5 15 672 Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 186 Folder The folder containing the original item. 5386 Series The series number of the original item. Series VIII Subseries I Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Source A related resource from which the described resource is derived Pesticide and Toxic Chemical News Date A point or period of time associated with an event in the lifecycle of the resource November 17 1982 Title A name given to the resource Articles: Pesticide Misuse, and Agent Orange Study Won't Solve Policy Problems ao_seriesVIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 185 Folder The folder containing the original item. 5368 Series The series number of the original item. Series VIII Subseries I Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Simon, Rob Source A related resource from which the described resource is derived Stars and Stripes Date A point or period of time associated with an event in the lifecycle of the resource January 14 1982 Title A name given to the resource Ask the Lawyer ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/698d3e78a6d313c6960aea19df50179b.pdf 3a841c263481077a2ae592db30c5f222 PDF Text Text Item D Number 05307 Author Warren, Edward W. Corporete Author Dow Report/Article Title D NotSBannefl Before the Chemical Company Environmental Protection Agency (EPA) of the United States of America, In re: The Dow Chemical Company, et al., Docket Nos. 415, et al., The Dow Chemical Company's Pretrial Risk Brief Journal/Book Title Year 198 Month/Day January 25 Color Number of Images ° D 64 Descripton Notes Tuesday, March 05, 2002 Page 5307 of 5363 �BEFORE THE ENVIRONMENTAL PROTECTION AGENCY OF THE UNITED STATES OF AMERICA In Re: Docket Nos. 415, et al, The Dow Chemical Company, et al. THE DOW CHEMICAL COMPANY'S PRETRIAL RISK BRIEF Edward W. Warren L. Mark Wine Richard L. McConnell John A. Zackrison KIRKLAND & ELLIS 1776 K Street, N.W. Washington, D.C. 20006 (202) 857-5000 Of Counsel: Rudolf H. Schroeter John Scriven Mark Tucker Dow Chemical U.S.A. 2030 Dow Center Midland, Michigan 48640 LA FOLLETTE, JOHNSON, SCHROETER, & DE HAAS 320 North Vermont Avenue Los Angeles, California 90004 Counsel for The Dow Chemical Company January 25, 1980 �TABLE OF CONTENTS PAGE INTRODUCTION 1 I. REGULATORY HISTORY 3 II. THE PROPONENTS OP CANCELLATION OR RESTRICTION BEAR THE BURDEN OF GOING FORWARD TO ESTABLISH A PRIMA FACIE CASE UNDER FIFRA'S EXPLICIT RISK/BENEFIT BALANCING STANDARDS ... 11 HUMAN EXPOSURE TO 2,4,5-T, SILVEX, AND TCDD OCCURS, IF AT ALL, ONLY AT MINUTE QUANTITIES POSING NO SIGNIFICANT RISK 15 III. A. Patterns of Use and Application Techniques Limit the Potential for Direct Spray Exposure 18 B. . Actual Exposure Measurements Under Field Conditions Show That the Potential for Direct Human Exposure During Aerial Application Is Extremely Limited . 19 C. There Is Little/ If Any, Potential For Indirect Human Exposure to 2,4,5-T, Silvex, or TCDD Through Environmental or Dietary Residues 21 1. The Environmental Behavior of 2,4,5-T, Silvex, and TCDD Prevents Environmental Accumulation and Contamination 21 a. 2,4,5-T and Silvex 22 b. TCDD 24 �TABLE OF CONTENTS (continued) PAGE 2. 28 TCDD 30 Human Monitoring Results Demonstrate Conclusively That No Significant Human Exposure Occurs 33 THE THEORETICAL CARCINOGENIC RISK POSED BY 2,4,5-T AND SILVEX PRODUCTS CONTAINING TCDD IS EXTREMELY SMALL, AND WELL WITHIN ACCEPTABLE LIMITS . . 34 A. B. C. D. V. 2,4,5-T and Silvex b. IV. 26 a. D. Extensive Environmental Monitoring Programs Reveal 2,4,5-T, Silvex, and TCDD Residues Only in Exceptional Cases, At Extremely Low Concentrations 2,4,5-T and Silvex Produce No Measurable Carcinogenic Effects in Test Animals 35 TCDD Produces Observable Carcinogenic Effects Only At Relatively High Doses Producing General Toxicity . . . . 38 Quantitative Risk Assessments Demonstrate That the Small Theoretical Risk Posed by Trace Amounts of TCDD in 2,4,5-T and Silvex Products Is Well Within Acceptable Limits ... 41 Long-Term Epidemiological Evidence Fails to Show Increased Carcinogenic Risk From High TCDD Exposure 44 2,4,5-T AND SILVEX PRODUCTS PRESENT NO REPRODUCTIVE RISK TO HUMANS UNDER CURRENT USE PRACTICES A. EPA's Alsea II Study Supplies No Evidence Whatsoever of Adverse Reproductive Effects in Humans ii 46 47 �TABLE OF CONTENTS (continued) PAGE B. Well-Established No-Effect Levels for 2,4,5-T, Silvex, and TCDD Show Substantial Margins o,f Safety for Applicators and the Public 49 1. 2,4,5-T and Silvex 50 2. TCDD 52 C. Data Generated Following the Seveso Accident Confirms the Absence of Reproductive Risk From TCDD Exposure 56 CONCLUSION 58 iii �BEFORE THE ENVIRONMENTAL PROTECTION AGENCY OF THE UNITED STATES OF AMERICA In Re: ) The Dow Chemical Company, et al. ) ) Docket Nos. 415, et al, THE DOW CHEMICAL COMPANY'S PRETRIAL RISK BRIEF * INTRODUCTION In accordance with the Administrative Law Judge's directions, The Dow Chemical Company (Dow) submits this pretrial brief on the risk issues, presenting a concise » overview of the entire risk case. While the evidence to be presented in these consolidated hearings is voluminous, the organization of this brief and the issues themselves are straightforward. The evidence will show that all uses of 2,4,5-T and silvex are safe, that these herbicides present no reproductive risk, and that the extremely small potential carcinogenic risk predicted for TCDD is well within acceptable limits. Accordingly, 2,4,5-T and silvex products should be approved for all registered uses, and each and every registration subject to the Agency's Section 6(b)(l) and Section 6(b)(2) hearing notices should be continued in full force and effect. �- 2- Part I of this brief presents a brief history of 2,4,5-T and silvex, showing more than 30 years of safe use with substantial economic and social benefits. This part also summarizes the years of extensive regulatory and scientific scrutiny which assure the safety of these herbicides, as well as the more recent developments which set the stage for these hearings. Part II addresses OGC's burden of going forward with the evidence to establish an affirmative case for cancellation or restriction, and the elements of such a prima facie case under FIFRA's risk/benefit balancing standards. Fart III addresses the critical issue of human exposure potential. Careful analysis of application techniques and patterns of use, environmental behavior characteristics, residue testing results, and pharmacokinetics data shows that the quantities of 2,4,5-T, silvex, and 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD)=/ to which humans might be exposed, either directly or indirectly, are extraordinarily minute. In Part IV, we set forth the extensive data showing that 2,4,5-T and silvex are not carcinogenic, and the results of carcinogenicity testing with the trace contaminant TCDD. Even using greatly exaggerated assumptions regarding exposure, and the most conservative risk-assessment models, the "I/ Although there are 22 different tetrachlorodibenzo-pdioxins isomers, in this brief, TCDD refers only to 2,3,7,8tetrachlorodibenzo-p-dioxin, the isomer present in 2,4,5-T and silvex. �- 3 - risks potentially posed to applicators and the general public are extremely small, well below acceptable levels of risk established by EPA and other federal regulatory agencies. Part V deals extensively with the evidence on reproductive risk, including both fetotoxic and teratogenic risk. Comparison of the minute human exposure potential to wellestablished no-effect levels for 2,4,5-T, silvex, and TCDD demonstrates high margins of safety for all of these compounds. The absence of reproductive hazard is confirmed by observations made at Seveso, Italy, where the general population was exposed to high levels of TCDD produced in the explosion of a trichlorophenol plant, without adverse reproductive consequences. I. REGULATORY HISTORY. 2,4,5-T and silvex are phenoxy herbicides used for selective control of broadleaved weeds, brush, and undesirable trees. Developed during the 1940's, 2,4,5-T was first registered as a pesticide in 1948, and silvex was registered in 1954. For more than 30 years, these products have been used safely and effectively in countries throughout the world. Although the extensive economic and social benefits derived from these products will be addressed fully in the benefits case, the brief summary of uses presented here helps place the risk issues in perspective. �- 4- In modern range and pasture management, 2,4,5-T and silvex are used to control weeds and brush such as mesquite which otherwise would crowd out forage grasses, and to control poisonous plants dangerous to grazing animals. These management practices greatly enhance range productivity, and replace environmentally destructive alternatives such as burning or plowing. Forest productivity is also increased by the use of 2,4,5-T and silvex for site clearance and conifer release. 2,4,5-T and silvex are used to eliminate harmful tree species that would otherwise inhibit or prevent conifer growth. As with rangeland, the use of these herbicides in the forest replaces environmentally destructive alternatives, and in addition prevents'injuries to workmen using chain saws and other dangerous implements. » Similarly, 2,4,5-T and silvex are used to maintain rights-of-way along utility lines, roads, and railroads, and to control weeds in many non-crop areas, ditches, lawns, recreational sites, and so forth. Significantly cheaper than alternatives such as manual clearing, the aerial application of these herbicides also permits control in otherwise inaccessible locations. In rice growing, 2,4,5-T and silvex are used to control competing weeds, thereby markedly increasing yield. Silvex is also used to increase sugar cane productivity and to prevent fruit-drop on orchard crops such as apples and prunes. �- 5- Throughout the more than thirty years these pesticides have been used, and particularly during the last decade, 2,4,5-T, silvex, and TCDD have been subjected to intense scientific and regulatory review, providing a safety evaluation far more comprehensive than available for most commonly used chemicals and drugs. The extensive evidence developed by federal agencies, by industry, and by academics in the United States and abroad fully support the safety of these herbicides. Recent regulatory review of 2,4,5-T began in 1970, with proceedings before the Secretary of Agriculture.=/ Pursuant to a referral from the Secretary, in February 1971 the National Academy of Sciences Advisory Committee on 2,4>5-T endorsed continued-use of 2,4,5-T on forests, rangeland, and rights-of-way, and recommended a maximum manufacturing specification of 0.1 ppm TCDD.=/ After assuming administration of FIFRA late in 1970, EPA continued the regulatory review of 2,4,5-T begun by the Secretary of Agriculture, and in 1973 set hearings on all 2/ The Secretary of Agriculture administered FIFRA until December 18, 1970, when administration of the Act was transferred to EPA. 35 Fed. Reg. 19169 (December 18, 1970). Report of the Advisory Committee on 2, 4^5-T to the Administrator of the Environmental Protection Agency, National Academy of Sciences (unpublished 1971). The 0.1 ppm standard remains as the manufacturing specification, but improved manufacturing capabilities currently yield commercial 2,4,5-T at much lower TCDD concentrations. �- 6- uses of 2,4,5-T, to begin in April 1974.^ But in March 1974, a Scientific Workshop comprised of leading scientists from around the world firmly endorsed the safety of 2,4,5-T.^/ After continuing the scheduled hearing date and tentatively expanding the scope of the hearing to include silvex and other herbicides,^/ EPA withdrew its hearing notices on June 24, 1974.2/ Following EPA's abandonment of the 1974 hearings, Dow, EPA, and others participated in the Dioxin Implementation Plan, a comprehensive and cooperative program for monitoring possible TCDD residues in human and environmental samples. Beginning in April 1978,=/ Dow and many other interested persons participated in EPA's RPAR review of 2,4,5-T through submission of extensive data and comments to the Agency. Dow believed that both the Implementation Plan and the RPAR 4/ EPA, "2,4,5-T: Intent to Hold Hearing," and EPA, ^2,4,5-T: Statement of Issues," 38 Fed. Reg. 19859 (July 24, 1973). 5/ USDA Memorandum from R.W. Fullerton, et al. to Administrative Law Judge Frederick penniston, Workshop Participants, and Parties to 2,4,5-T Hearing Re Final Report of 2,4,5-T Scientific Workshop (1974). 6/ EPA, "2,4,5-T: Intent to Hold Hearing" 38 Fed. Reg. 19859 (July 24, 1973). 7/ EPA, "2,4,5-T and Herbicides Potentially Containing TCDD: Withdrawal of Cancellation and Withdrawal of Intent to Hold Hearings," 39 Fed. Reg. 24049 (June 24, 1974). 8/ EPA, "Rebuttable Presumption Against Registration and Continued Registration of Pesticide Products Containing 2,4,5-T," 43 Fed. Reg. 17116 (April 21, 1978). �- 7- review offered an opportunity for dispassionate scientific investigation and exchange. This cooperative scientific effort was shattered on March 1, 1979, when EPA issued unprecedented "emergency" suspension orders for major uses of 2,4,5-T and silvex, based on the now discredited Alsea II study.-' The Alsea II report was prepared secretly with no opportunity for scientific peer review, and EPA deprived Dow and other RPAR * participants of advance notice or opportunity to comment on the "emergency" suspensions, which were weeks in preparation.-—' Along with the suspension orders, EPA issued Section 6(b)(l) cancellation hearing notices for each of the suspended uses.—=/ Dow and other parties filed timely objections to the hearing notices, initiating these cancellation hearings.—' Dow^ immediately challenged the ill-founded suspensions in District Court. Under circumstances which effectively EPA, "Decision and Emergency Order Suspending Registrations for the Forest, Rights-of-Way, and Pasture Uses of 2,4,5-T," 44 Fed. Reg. 15874 (March 15, 1979); EPA, "Decision and Emergency Order Suspending Registration for Certain Uses of Silvex," 44 Fed. Reg. 15897 (March 15, 1979). ip/ See Transcript of Press Conference by Barbara Blum at 30 (March 1, 1979). ll/ EPA, "2,4,5-T: Notice of Intent to Cancel the Forestry, Rights-of-Way, and Pasture Registrations of Pesticide Products Containing 2,4,5-T," 44 Fed. Reg. 15893 (March 15, 1978) and EPA," Notice of Intent to Cancel Certain Registrations of Pesticide Products containing Silvex," 44 Fed. Reg. 15917 (March 15, 1979). 12/ See Request for Hearing and Objections on Behalf of Registrant The Dow Chemical Company (filed April 9, 1979). �- 8- precluded full scientific review of Alsea II, including the Agency's surprise introduction of new data on the final day of trial, the court "reluctantly" declined to set aside the suspensions, but concluded that it would not have suspended registration based on the evidence before the Agency.==/ Subsequently, the Alsea II report has been reviewed and repeatedly discounted by independent scientific reviewers, including most recently an interdisciplinary task force • assembled by the Environmental Health Sciences Center at Oregon State University. The Oregon State task force concluded * EPA erred seriously in each of the three conclusions in the Alsea II Report. If there is a relationship between herbicide use and miscarriage in the "Alsea Basin" and its' surrounding area, it is not apparent and cannot be tested using the data from the Alsea II study.14/ Similar conclusions were reached in reviews conducted by the governments of Great Britain, =2/ Australia,^' and New 13/ "[T]he Court will frankly concede that it arrives at this decision with great reluctance and would not in its judgment have ordered the emergency suspensions on the basis of the information before the EPA." The Dow Chemical Co. v. Barbara Blum, 469 F. Supp. 892, 907 (E.D. Mich. 1979). 147 Environmental Health Sciences Center, Oregon State University, A Scientific Critique of the EPA Alsea II Study and Report at 46(October 25, 1979)(Hereinafter "Oregon State Critique"). 15/ Transcript from House of Lords, "Dioxin and Synthetic cEemicals: Hazards," at 1394 (July 17, 1979). 16/ Snelson, J.T., "Observations and Comments on the Report of Investigations of Spontaneous Abortion Rates in Oregon" (1979). �- 9- Zealand,-—/ at the June scientific conference on 2,4,5-T sponsored by the American Farm Bureau,==/ and in a detailed report prepared by Dr. Steven Lamm and submitted by Dow to the Scientific Advisory Panel and to the Agency in August. In July, EPA published proposed Section 6(b)(2) hearing notices for the nonsuspended uses of 2,4,5-T and silvex.=^/ Apparently recognizing the futility of continued reliance on Alsea II, the Agency staff based its arguments on poorlyreasoned reinterpretations of animal test data. Unlike the Section 6(b)(l) cancellation notices issued in March, EPA was required by law to submit the proposed Section 6(b)(2) notices to the FIFRA Scientific Advisory Panel for review.—/ At hearings conducted in August and 177 Becroft, D.M.O., et al. (Reviewers), "An Evaluation of the Preliminary Report of Assessment of a Field Investigation of Six-year Spontaneous Abortion Rates in Three Oregon Areas in Relation to Forest 2,4,5-T Spray Practices," New Zealand Department of Health (May 1979). 18/ American Farm Bureau Federation, Scientific Dispute Resolution Conference on 2,4,5-T (August, 1979). 197 Lamm, Steven H., Afl Epidemiclogic Assessment of the Alsea II Report (August 6, 1979). 20/ 44 Fed. Reg. 41531 (July 17, 1979). 21/ FIFRA Section 6(b), 25(d). The statute permits EPA to omit Scientific Advisory Panel review where a cancellation hearing notice is issued in conjunction with a suspension. Although the Panel expressly requested permission to review the notices issued in March, the Agency refused to submit them for review. See Memorandum from the Executive Secretary, FIFRA Scientific Advisory Panel, to the Administrator (April 17, 1979) (transmitting the Panel's unanimous resolution and setting forth the Panel's reasons for wishing to review the 2,4,5-T and silvex notices). �- 10 - September, the Panel reviewed extensive scientific evidence submitted by Dow and EPA. Rejecting key aspects of EPA's arguments, the Panel found that potential exposure related to the nonsuspended uses does not "suggest . . . the possibility of significant risk."—' Accordingly, the Panel expressly recommended that no Section 6(b)(2) hearing be held at this time.^/ In light of the Scientific Advisory Panel's considered • judgement on the risk issues, the proper and prudent course would have been to withdraw the proposed Section 6(b)(2) notices and proceed no further. But EPA determined to proceed with final 6(b)(2) notices in the face of the Panel's report, apparently before the Agency's technical staff had even been given an opportunity to review the Panel's report in detai^.. 2i/ In expressly acknowledging the absence of an "imminent hazard" for the nonsuspended uses,^/ the final Section 227 FIFRA Scientific Advisory Panel, Review of Notices of Intent at 6 (September 27, 1979) (hereinafter "SAP Report"). 237 SAP Report at 2. 247 See Weekly Operational Report From OPP (November 8, 1979) [reporting that Deputy Assistant Administrator Edwin Johnson already had decided to proceed with Section 6(b)(2) hearings and that "A formal response to the SAP Report will be published in the Federal Register after an in depth review by EPA scientific staff." (emphasis supplied)].See also Letter from Steven D. Jellinek to Thomas S. Foley (November 14, 1979). 257 EPA, "Preliminary Determination Concerning RPAR of Certain Uses of Pesticide Products Containing 2,4,5-T and Silvex," 44 Fed. Reg. 41531, 41536, 41542 (July 17, 1979). �- 11 6(b)(2) notices tacitly acknowledge the lack of foundation for the March suspensions. Indeed, OGC itself has recently conceded that: [Assessment of risk for all uses covers the same or similar factual ground in such areas as toxicology, environmental stability, exposure potential, and chemi s try.267 Yet, even though the risks for all uses are essentially the same, EPA apparently has given no consideration to withdrawing » the unsupportable suspension and cancellation notices, Dow and other interested parties have responded to the Section 6(b)(2) notices by stating their intent to participate fully in Section 6(b)(2) hearings on the nonsuspended uses The Chief Administrative Law Judge has consolidated the Section 6(b)(l) and 6(b)(2) proceedings, so that these hearingsfwill encompass all suspended and nonsuspended uses of 2,4,5-T and silvex.—/ II. THE PROPONENTS OF CANCELLATION OR RESTRICTION BEAR THE BURDEN OF GOING FORWARD TO ESTABLISH A PRIMA FACIE CASE UNDER FIFRA'S EXPLICIT RISK/ BENEFIT BALANCING STANDARDS. EPA's hearing regulations, as well as the formal hearing requirements of the Administrative Procedure Act, require 267 Respondent's Motion for Consolidation at 2 (filed December.6, 1979). 277 See The Dow Chemical Company's Response to Section 6(b)(2) Statements of Issues for the Nonsuspended Uses of 2,4,5-T and Silvex (filed January 10, 1980). 28/ Order of Consolidation (filed December 14, 1979). �- 12 - the proponents of cancellation or restriction to bear the burden of going forward with the evidence in these Section 6(b)(l) and 6(b)(2) proceedings. Accordingly, OGC, EDF, and NCAP bear the burden of establishing a prima facie case for regulatory action/ under the risk/benefit balancing requirements of FIFRA. The regulations governing these hearings expressly provide that "the proponent of cancellation or change in classification has the burden of going forward to present"an affirmative case for the cancellation or change in classification of the registration." 40 C.F.R. § I64.80(a). The regulations also provide that in hearings "called by the Administrator" (Section 6(b){2) hearings), "the Respondent [OGC] has the burden of going forward to present an affirmative case as to the statement of issues." • 40 C.F.R. § 164.80(a). Even absent these express provisions of the rules, the formal hearing provisions of the Administrative Procedure Act—' would require proponents of cancellation or other regulatory restrictions to bear the burden of going forward with the evidence in hearings under Section 6 of FIFRA. In 29/ The APA's formal hearing requirements apply here because FIFRA requires that the decision in hearings initiated under Section 6(b) be made on the record, after a hearing. 5 U.S.C. § 554. See United States v. Florida East Coast Ry. Co., 410 U.S. 224, 234-38 (1973); United States v. Allegheny-Ludlum Steel Corp., 406 U.S. 742, 756-57 (1972). �- 13 - Environmental Defense Fund v. EPA^-/ the court held that § 556(d) of the APA, requiring the proponent of a rule or order to bear the burden of proof, directs the proponents of suspension in Section 6 suspension hearings to bear the , burden of going forward. Similarly, this provision of the APA places the burden of going forward with the evidence on the proponents of regulatory restrictions in Section 6(b)(l) and 6(b)(2) hearings. * Consequently, OGC, NCAP, and EDF bear the burden of going forward to show a prima facie case that the registrations at issue in these hearings do not meet the registration standards set out in FIFRA. As shown below, establishment °f a prima facie case requires affirmative proof of a signift icant risk, affirmative proof quantifying the benefits of continued use and the impact of cancellation or restrictions, and, ultimately, a demonstration that the risk posed by continued use outweighs the benefits of continued use. Cancellation or restriction of registrations may be based on a finding that the registered pesticide, "when used in accordance with widespread and commonly recognized practice, generally causes unreasonable adverse effects on the environment. "=•=/ FIFRA defines unreasonable adverse effects on the 30/ 548 F.2d 998 (D.C. Cir. 1976), supplemental opinion on petition for rehearing, 548 F.2d 1012 (D.C. Cir. 1971). 31/ FIFRA Section 6(b); see Section 3(c)(5)(d). Although Section 6(b) permits regulatory action on other bases, such as labelling which does not comply with statutory requirements, there is no suggestion that OGC relies on such a theory in this case. �- 14 - environment as "any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of [the] pesticide.»=•=/ Thus, the Act requires an explicit balancing of economic, social, and environmental benefits against the risk, if any, to determine whether such risk is "unreasonable." Accordingly, the proponents of cancellation or restriction first must show by affirmative evidence the existence • of a significant risk. Unsubstantiated or hypothetical allegations, unsupported by substantial evidence, should be accorded no weight in the statutory weighing of risks and benefits. Moreover, the risk considered must be that posed by the pesticide "when used in accordance with widespread and commonly recognized practice" — not the risk which might be,presented by misuse or abuse. Second, the proponents of cancellation must introduce affirmative proof quantifying the benefits of continued use and the impact of the advocated cancellation or restrictions. The economic and social benefits to be considered under the Act range broadly, including increased productivity, economic savings to users and consumers, and enhanced health and safety for workers and the public. Likewise, environmental benefits, such as the avoidance of adverse environmental consequences caused by alternative control methods which would replace the pesticide, must also be considered. 327 FIFRA Section 2(bb) (emphasis supplied). �- 15 - Third, the proponents of cancellation or restriction must demonstrate that, considering all risks and benefits attributable to the pesticide, the risks of continued registration are "unreasonable." This ultimate balancing of risks and benefits can be performed, of course, only at the conclusion of both risk and benefits presentations. III. HUMAN EXPOSURE TO 2,4,5-T, SILVEX, AND TCDD OCCURS, IF AT ALL, ONLY AT MINUTE QUANTITIES POSING NO SIGNIFICANT RISK. Any assessment of the risk to humans posed by a toxic substance depends critically on an accurate determination of the dose to which humans might be exposed. At low levels of exposure, there will be no substantial human risk. In this case, the potential for human exposure is confined almost exclusively to applicators, and even these exposures are so small as to present no substantial risk whatsoever. Non-applicators are so rarely exposed, at such extremely low levels, that continued use of 2,4,5-T and silvex products presents virtually no risk to members of the public. It is axiomatic among toxicologists, and consistent with everyday experience and common sense, that toxic substances exhibit a direct relationship between dose and response, with increased toxic effects seen at higher doses and decreased or no toxic effects seen at lower doses. The dose-response principle applies equally to measurements of �- 16 - fetotoxic, teratogenic, and carcinogenic effects, as well as other forms of toxicity. All fetotoxic and teratogenic compounds exhibit no-effect levels, which can be determined in properly conducted experimental studies which employ appropriate test doses. Below the no-effect dose, no toxic effects are observed. Accordingly, where exposure is below the no-effect level, no risk is presented and a margin of safety exists.3-^/ • Many experts believe that no-effect levels also exist for some or all carcinogens; others, however, contend that there is no "threshold" level for carcinogenic effects, and that some risk should be assumed even at the lowest doses of exposure. Nevertheless, scientists universally agree that « carcinogens, like other toxic substances, follow a doseresponse, relationship, so that the incidence of carcinogenic effects decreases as exposure decreases. Accordingly, for many substances the degree of risk posed by different levels of exposure can be calculated and compared to other risks deemed acceptable by society. Despite the critical importance of exposure data, OGC's contentions regarding exposure consist of little more than speculation — contradicted by all the available evidence — that new evidence not yet developed may show significant 337 A margin of safety represents the difference between expected exposure levels and the established no-effect level. EPA commonly accepts safety margins of 100 fold in regulating pesticides and other substances. �- 17 human exposure. Indeed, the exposure analysis published with the final Section 6(b)(2) notices begins with an admission of the Agency's "need for additional data," and is devoted almost exclusively to the discussion of ongoing or planned studies for which no results are available.-^/ The Agency's reluctance to address the existing evidence is understandable, particularly in light of the Scientific Advisory Panel's thorough and explicit rejection of the » exposure analysis advanced in the July Section 6(b)(2) position documents.^/ While recognizing the need for continuing data collection, the Panel expressly rejected the Agency's position on each of four exposure questions submitted to the Panel by the Agency. =^/ The Panel summarized its conclusions as follows: The monitoring data obtained thus far does not suggest that TCDD derived from commercial 2,4,5-T and Silvex exhibits any tendency to accumulate in the human food chain in amounts which would pose a substantial risk.37/ Similarly, the Panel found that "current monitoring data do not indicate that there is a substantial reproductive or 34/ EPA, 2,4,5-T/Silvex Position Document 4, 44 Fed. Reg. 72320, 72322-23 (2,4,5-T Notice); 44 Fed. Reg. 72333, 72335-36 (Silvex Notice). 3_5/ SAP Report at 4-6. 36/ SAP Report at 4-6. 37/ SAP Report, Appendix I at 8. �- 18 - teratogenic risk posed by the accumulation of TCDD in the human food chain. »=•=/ The available evidence demonstrates that there is no significant potential for human exposure to 2,4,5-T, silvex, or TCDD. As shown below, analysis of use and application patterns, the environmental behavior of 2,4,5-T, silvex, and TCDD, the results of residue testing programs, and field studies of human exposure show that potential human exposure * is extraordinarily small. In conjunction with the extensive data on carcinogenicity and reproductive effects discussed in Parts IV and V of this brief, the data described below provide sound assurance that the continued use of these herbicides presents no significant risk to applicators or to members of the public. A. ' Patterns of Use and Application Techniques Limit the Potential for Direct Spray Exposure. Under constantly improving manufacturing practices, recent commercial grade 2,4,5-T and silvex products produced by Dow and others contain <_ 0.025 ppm TCDD, well below the 0.1 ppm manufacturing specification set in 1971.=•2' Further 387 SAP Report, Appendix I at 11. 397 This figure of $ 0.025 ppm is based on the highest concentration of TCDD detected in recent tests conducted by an EPA contractor using 16 commercial samples of 2,4,5-T from five manufacturers. The tests showed a range of concentration from "not detectable" to 0.025 ppm in 2,4,5-T, excluding higher values reported as doubtful by the contractor, Similar tests with 8 commercial silvex samples showed TCDD ranging from 0.012 to 0.024. 2,4,5-T Position Document 2/3 at 8, note; Silvex Position Document 1/2/3 at 9, note. �- 19 - reductions in TCDD content may be possible on the basis of continuing advances in technology. Even at present levels, however, only a few ounces of TCDD are present in all 2,4,5-T and silvex products used annually in the United States. 2,4,5-T and silvex usually are applied as liquid formulations, diluted in a carrier of diesel oil, water, or oil-in-water emulsions.2H/ in aerial application, rigorous controls, including a ban on aerial spraying during-excessive * winds, the use of special spray apparatus to control droplet size and direction, and other restrictions greatly limit the potential for spray drift. B. Actual Exposure Measurements Under Field Conditions Show That the Potential for Direct Human Exposure During Aerial Application Is Extremely Limited. Pesticide applicators experience small direct exposures in the scope of their employment, and there is a potential for extremely minute, direct exposure to bystanders who on isolated occasions might be sprayed inadvertently during application. Careful application techniques, however, limit possible direct exposure through spray drift. Actual measured levels of exposure for applicators are very low, and potential exposure levels calculated for incidental bystanders are extremely low. 40/ 2,4,5-T and silvex formulations are applied by aerial spray, by spray trucks or tractors, or by back-pack spray apparatus carried by the applicator. In addition, silvex may be applied as a granular solid for home and lawn use. �- 20 - Actual exposure levels for applicators were established in a comprehensive field study conducted in August 1978, with workers engaged in ordinary spray application of 2,4,5-T. This study, sponsored by the National Forest Products Association, contains highly accurate data concerning the exposure potential in most common applications. The nineteen men and two women who served as subjects in the study were personnel regularly employed as pesticide applicators, and were given * no special instructions or safety precautions. For example, the workers did not wear protective clothing, and some wore sleeveless shirts,^i/ Exposure levels were calculated from measurements of 2,4,5-T excreted in the urine, based on known rates of * 2,4,5-T metabolism and excretion determined in experimental animals and in human volunteers.^/ The results show that the applicators absorbed very small amounts of 2,4,5-T. As one would logically expect, the levels of exposure varied by the particular jobs and application techniques employed. For example, the highest exposure was measured in 41/ Lavy, T.L., "Measurement of 2,4,5-T Exposure of Forest Workers," submitted as part of Project Completion Report to National Forest Products Association RPAR Response (1978). 427 Ramsey, J.R., et al., "Exposure of Forest Workers to 2,4,5-T: Calculated Dose Levels," submitted as part of Project Completion Report to National Forest Products Association RPAR Response (1979). 2,4,5-T is excreted rapidly in humans, with 98% of the administered dose excreted within one week. Gehring, P.J., et al., "The Fate of 2,4,5-Trichlorophenoxyacetic Acid (2,4>5-T) Following Oral Administration to Man," Toxicol. Appl. Pharmacol. 26 at 352-361 (1973). �- 21 - mixers, who come into direct contact with the herbicide concentrate as well as the spray solution. Backpack sprayers have less exposure, and helicopter pilots even less. Flagmen who stood directly in the spray path have even smaller exposures, even though they were directly in the spray path for eight helicopter passes per day. Thus, the flagmen received eight times the dose which a bystander accidentally sprayed on a single pass would be likely to receive. Finally, while the measured 2,4,5-T exposures are very small, calculated exposures to the minute traces of TCDD present in the herbicide are infinitesimally small. C. There Is Little, If Any, Potential For Indirect Human Exposure to 2,4,5-T, silvex, or TCDD Through Environmental or Dietary Residues. * Following application, 2,4,5-T, silvex, and TCDD decompose rapidly, do not accumulate in the environment, and are found only rarely, at very low concentrations, in environmental samples. All of these factors limit the potential for human exposure through food and water to quantities so exceedingly small as to be toxicologically 1. insignificant. The Environmental Behavior of 2,4,5-T Silvex, and TCDD Prevents Environmental Accumulation and Contamination. The chemical properties of 2,4,5-T, silvex, and TCDD, which determine their environmental behavior, are critical �- 22 - to any assessment of risk. As shown below, 2,4,5-T and silvex decompose and do not accumulate in the environment; contamination of surface and ground water is extremely unlikely. TCDD undergoes extremely rapid photodegradation, degrades in soil, and is extremely insoluble in water. TCDD contamination of surface or ground water is therefore extremely unlikely. • a. 2,4,5-T and Silvex. 2,4,5-T and silvex are generally applied as high molecular weight esters, which degrade rapidly. The joint USDA/ States/EPA Assessment Team for 2,4,5-T found that "under normal application practices, initial levels of 2,4,5-T in soils are usually low and disappear relatively rapidly."—/ • Rapid environmental degradation of these herbicides after application is confirmed by field studies, in which precise measurements of residues taken immediately after application and at intervals thereafter show rapidly decreasing concentrations of 2,4,5-T and silvex. studies of residues on foliage, on the forest floor, in soil, and on 43/ USDA/States/EPA 2,4,5-T Assessment Team, Biologic and Economic Assessment of 2,4,5-T at 5-28 (February 15, 1979) (hereinafter "Assessment Team Report.") Included in the Team's comprehensive report is extensive evidence concerning environmental fate and exposure. The Secretary of Agriculture's witness list filed in these proceedings indicates that many of the experts assembled to develop the Assessment Team Report will testify concerning these data. �- 23 - grasslands demonstrate short half-lives, with most of the herbicides disappearing within days or weeks.—' 2,4,5-T and silvex also degrade rapidly in water. Field studies demonstrate that the residues detectable immediately following experimental application of these herbicides directly to water follow the same pattern of decomposition observed on foliage, grasslands, and soil.—' The National Academy of Sciences Safe Drinking Water * Committee found that contamination of drinking water or other surface water is extremely unlikely.^/ In addition to the rapid decomposition described above, the minute quantities of 2,4,5-T and silvex which might be dissolved or 44/ See, e.g., Altom, J.D., et al., "Degradation of Dicamba, Picloram, and Four Phenoxy HerEicTdes in Soils," Weed Science 21(6) at 557 (1973) (half lives for 2,4,5-T and silvex on grassland and forest sites ranged from 14 to 24 days); Jensen, D.J., et al^, "Dissipation of Silvex from Soil in Fields Treated With Kuron Herbicides," unpublished, The Dow Chemical Company (1975) (Confidential) (silvex concentrations in soil decreased rapidly and were nondetectable within one year); Norris, L.A., et al., "The Persistence of 2,4,5-T in a Pacific Northwest Forest," Weed Science 25(5) at 417 (1977) (comprehensive field study examining samples from foliage, forest floor, and soil showed 90% decline in 2,4,5-T residues within six months). 45/ See Bailey, G.W., et al., "The Degradation Kinetics of an Ester of Silvex and the Persistence of Silvex in Water and Sediment," Weed Science 18 at 413 (1970) (the concentration of silvex in water decreased to 0 by 3 weeks); Frank, P.A., "Herbicidal Residues in Aquatic Environments," Adv. Chem. Ser. ill at 135 (1972) (non-purposeful herbicide contamination of natural waters occurs infrequently and at low levels). 46/ National Academy of Sciences, "Drinking Water and Health," Safe Drinking Water Committee at 500 (1977). �- 24 - suspended in water are quickly dissipated in streams by dilution.^!/ Studies also show that 2,4,5-T and silvex are relatively immobile in soil and do not leach significantly. Thus, herbicide residues remain within a few inches of the soil surface, and do not leach into ground water.—' The USDA Assessment Team found that contamination of "ground water supplies is very unlikely."^' » In short, 2,4,5-T and silvex are not persistent in the environment, and do not accumulate in environmental substrates such as soil or sediment. In addition, the chemical proper- ties of these herbicides limit environmental mobility and preclude contamination of ground and surface water. b. TCDD. TCDD decomposes rapidly following application. Thus, even the extraordinarily minute concentrations of TCDD present following herbicide applications disappear quickly. TCDD undergoes extremely rapid photodegradation in sunlight, in the presence of hydrogen donors such as the 47/ Assessment Team Report at 5-1. 48/ Norris, L.A., et al., "The Persistence of 2,4,5-T in a Pacific Northwest Forest," Weed Science 2_5(5) at 417 (1977) (forest field study showing no 2,4,5-T residues below 6 inches in soil on the forest floor); Wiese, A.F., et al., "Herbicide Movement in Soil and Various Amounts of WaterT71"Weeds 12(2) at 101-2 (1964) (experimental application of silvex to soil in tubes, with, silvex remaining within 3 inches of soil surface). 49/ Assessment Team Report at 5-1. �- 25 - hydrocarbons found in 2,4,5-T and silvex formulations and the waxy surfaces of leaves. Almost all 2,4,5-T and silvex (and therefore TCDD) initally comes to rest on foliage. Within 24 hours, TCDD contained in a thin herbicide film on leaves, soil, or glass plates exposed to outdoor sunlight is broken down by photodegradation. ^ / The USDA Assessment Team concluded that because of rapid photodegradation and low TCDD content, under normal pesticide use TCDD is unlikely to be introduced into soil Nevertheless, TCDD degrades in soil at a half-life of about one year.^/ Thus, the extremely small quantities of TCDD which may sometimes escape immediate photodegradation decompose after entering the soil. TCDD is extremely insoluble in water. =2/ contamination of surface water or water supplies is therefore highly unlikely. Moreover, TCDD adheres strongly to sediment and particulates,-^' and normally remains on the surface of plants SO/ Crosby, D.G., et al., "Environmental Degradation of TCDD," Science 195 at 1337 (1977). 5I/ Assessment Team Report at 5-63. 527 Young, A.L., et al., "Field Studies on the Soil Persistence and Movement of 2,4-D, 2,4,5-T, and TCDD," Presentation to the Weed Science Society of America (1974)(half-life between six months and one year); USDA/EPA Assessment Report at 5-63 (about one year). 53/ Advisory Committee on 2,4,5-T, "Report to the Administrator of the Environmental Protection Agency" (1971). 54/ Ward, C.T., et al., "Fate of Tetrachlorodibenzo-p_-Dioxin (TCDD) in a Model Aquatic Ecosystem," Arch, of Environm. Contamin. Toxicol. 7 at 349-57 (1978). �- 26 - and soil.—' Accordingly, TCDD in soil is immobile and does not leach significantly.'^' The combination of extremely low solubility, rapid photodegradation, and immobility in soils prevents ground water contamination.—/ Thus, TCDD is not environmentally persistent and does not accumulate in the environment. Most TCDD contained in 2,4,5-T or silvex applications is destroyed by photodegradation within 24 hours of application. This rapid decomposition, as well as the insolubility and soil-adherence of* TCDD, prevent contamination of surface and ground water. 2. Extensive Environmental Monitoring Programs Reveal 2,4,5-T, Silvex, and TCDD Residues Only in Exceptional Cases, At Extremely Low Concentrations •. As shown above, application practices as well as environmental behavior characteristics limit possible environmental concentrations of 2,4,5-T, silvex, and TCDD to very low levels. Residue monitoring with extremely sensitive analytical testing procedures shows no detectable residues in most environmental and food samples, and only extraordinarily minute quantities of these compounds in the few "positive" samples, thereby demonstrating the absence of any substantial human exposure. 557 Assessment Team Report at 5-63. 56/ Id. 57/ Kearney, P.C., et al., "Tetrachlorodibenzodioxin in the Environment: Sources, Fate, and Decontamination," Environmental Health Perspectives § at 275 (Sept. 1973). �- 27 - Residue monitoring is performed with sophisticated gas chromatography and mass spectrometry equipment. The sensitivity of analytic testing is critically dependent on sample clean-up procedures, which remove potential sources of interference, on the capacities of the equipment used, on the procedures employed, and on the experience and skill of the scientists who perform the analyses. All of this infor^ mation must be considered in evaluating the results obtained * in these tests. Improvements in technology and procedures during the last few years have radically reduced detection limits for TCDD. Below the limit of detection, any trace residues which might be present are simply not detected; well above the detection limit, results showing either the presence or absence of residues are generally reliable. At or near the limit of detection, results are ambiguous and must be interpreted with caution. Because detection limits have changed significantly in recent years, evaluation of test data requires a thorough knowledge of the sensitivity of the test employed. Currently, the best analytic procedures for 2,4,5-T and silvex are sensitive in the part per billion range. For TCDD, the most sensitive current tests can detect residues as low as 1 part per trillion. �- 28 - a. 2,4,5-T and Silvex. Extensive monitoring, including samples from sediments, fish, rice, grazing animals, and consumer foodstuffs shows that no detectable residues of 2,4,5-T and silvex are present in the overwhelming majority of samples, and that the isolated "positive" residues results are at extremely low concentrations. Experimental feeding studies examining the tissues and milk of animals fed diets containing high levels of 2,4,5-T and silvex show no significant accumulation in any tissue, and also show rapid reductions in concentration following removal from the herbicide-added diet. Extensive "market basket" surveys and agricultural commodity surveys conducted annually by the Food and Drug Administration have shown no detectable residues of 2,4,5-T or silvex in any of the samples tested.—' Thus, there is no known human exposure to 2,4,5-T or silvex through the diet. Exhaustive searches for 2,4,5-T and silvex in water and in sediments from streams, ponds, and lakes have disclosed only isolated residues of 2,4,5-T and silvex. For example, EPA's National Surface Water Monitoring Program for Pesticides showed no residues in 600 bottom material (sediment) samples 58/ Memorandum from Frederick W. Kutz to Robert Brown, "Summary of Federal Monitoring Data on 2,4,5-T, Silvex and TCDD," at 6 (March 22, 1979) (hereinafter "Kutz Memorandum"). �- 29 - collected between May, 1976 and August, 1978. =-?/ The same study detected only 6 "positive" samples for 2,4,5-T out of 1350 whole water samples tested, five of them at less than 1 part per billion; out of 1350 water samples tested for silvex, only 2 positives were found, both at the same site. —' Similarly, EPA's computerized data base for 2,4,5-T and silvex monitoring contains the results of 30,000 samplings, primarily in water and sediment, only "a small percentage" of which showed detectable residues. -=/ Thus, as the environmental behavior characteristics of these compounds predict, their presence in the nation's streams, ponds, and lakes is virtually nil. Experimental feeding studies show that animals fed on experimental diets with lower doses of 2,4,5-T and silvex show no detectable residues in milk or cream, even during administration of the herbicide diet.—/ Even where cattle and sheep are deliberately fed high dietary levels of 2,4,5-T and silvex, only small concentrations of these herbicides are detected in milk or tissue during or immediately following 59/ Kutz Memorandum at 3. 60/ Id. 61/ Id. 627 Leng, M.L., "Residues in Milk and Meat and Safety to Livestock from the Use of Phenoxy Herbicides in Pasture and Rangeland," Down to Earth 28(1) at 12-15 (1972); Clark, D.E., et al., "Residues of Chlorophenoxy Acid Herbicides and Their pEenolic Metabolites in Tissues of Sheep and Cattle," J. Agr. Food Chem., 23(3) at 573, 576 (1975). �- 30 - feeding with the herbicide-treated diet. After only a few days on an untreated diet following termination of the herbicide diet, residues in these animals are greatly reduced or not detectable. These studies demonstrate conclusively that sheep and cattle grazing on range and pasture treated with 2,4,5-T and silvex could not accumulate significant residues in milk or tissue, since the residues present on edible foliage even » immediately following herbicide application are far below the exaggerated dose levels used in the experimental feeding studies. Moreover, label requirements, which prohibit the grazing of dairy animals on treated areas for periods of from one to six weeks following herbicide application/ further reduce the potential ingestion of 2,4,5-T or silvex residues, by permitting chemical degradation of herbicidal residues. Similarly, labels require that meat animals be withdrawn from treated areas at least two weeks before slaughter, permitting excretion of 2,4,5-T and silvex residues. b. TCDD. Monitoring for TCDD, including the multi-year Dioxin Implementation Plan undertaken by EPA, Dow, and others in 1974, has been as extensive as that for 2,4,5-T and silvex. Monitoring data show that TCDD, like its herbicide carriers, is found infrequently and only at extremely low levels. Moreover, recent research by Dow and others demonstrates that trace amounts of TCDD are produced in many ordinary �- 31 - combustion processes, such as those in coal-fired power plants and municipal incinerators. Thus, trace quantities of TCDD detected in monitoring programs may well derive from sources other than pesticides. Beef liver samples from cattle grazed on 2,4,5-T-treated rangeland tested in the Dioxin Implementation Plan showed no residues of TCDD, and the vast majority of beef-fat samples also showed negative results. A single sample showed a 60 part per trillion residue, while two samples showed* unvalidated residues at 20 ppt, and another five samples showed equivocal results close to the limit of detection.—' Samples of water, mud, catfish, walleyed pike, and bass \ from a pond containing water from heavily treated Arkansas rice fields, and from the San Angelo, Texas Reservoir which has as its watershed vast rangelands treated with 2,4,5-T, * showed no detectable residues of TCDD.^2/ similarly, rice samples obtained from high treatment rice fields and from retail stores throughout the country show no residues.—' 63/ EPA, "Dioxin Position Document," Draft Report of the Dioxin Working Group at 13 (April 26, 1977). 64/ Shadoff, L.A., et al., "A Search for TCDD in an Environment Exposed Annually to 2,4,5-T Acid Ester Herbicides," Bull, of Environm. Contamin. and Toxicol. 18(4) at 485 (1977). 65/ Jensen, D.J., et al., "Analysis for TCDD Residues in Rice Grain from Retail Stores and From Fields Treated With 2,4,5-T," Unpublished, The Dow Chemical Company (Confidential) �- 32 - Cattle and sheep fed exaggerated doses of TCDD for extended periods of time in experimental feeding studies show residues of TCDD in milk and tissues. Levels of TCDD in the milk and tissues remain constant during continued dietary exposure, and decrease following removal from the TCDD diet.^ The extraordinarily low concentrations of TCDD which might be present on range or pasture grasses immediately * following herbicide application are far below the dietary concentrations used in these feeding studies, and accordingly would produce no significant TCDD residues in milk or tissues if sheep and cattle were grazed on treated land on the day of application. Moreover, due to label restrictions which t prohibit grazing of dairy animals on treated areas for one to six weeks following application, almost all TCDD initially present photodegrades long before animals are returned for grazing. In addition, label restrictions and market practices result in the removal of all animals from the range weeks or months before slaughter, markedly reducing the potential for 66/ Jensen, D.J., R.A. Hummel, N.H. Mahle, C.W. Kocher, "A Residue Study on Beef Cattle Consuming 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD)," Unpublished, The Dow Chemical Company (1978) (Confidential). Jensen, D.J., R.A, Hummel, H.S. Higgins, L. Lamparski, E. Madrid, "A Residue Study on Sheep Consuming 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD)," Unpublished, The Dow chemical Company (1978) (Confidential). Jensen, D.J., R.A. Hummel, H.S. Higgins, L. Lamparski, E.T. Madrid, "Secretion of TCDD in Milk and Cream Following the Feeding of TCDD to Lactating Dairy Cows," Unpublished, The Dow Chemical Company (1978) (Confidential). �- 33 - TCDD residues in animals at slaughter. Accordingly, TCDD residues in meat and dairy products — if present at all -are both rare and at extremely low levels. D. Human Monitoring Results Demonstrate Conclusively That No Significant Human Exposure Occurs. The very small direct exposures measured in the LavyRamsey study, as well as the absence of any significant residues in water, grazing animals, and foodstuffs, demonstrate an extremely small potential for human exposure among the general public. The results of monitoring tests performed with samples of human urine and mother's milk confirm that no significant exposure occurs, showing no residues in most samples tested and only a few positive residues at extremely low concentrations. Results of EPA's monitoring program for TCDD in mother's milk released on January 15, 1 8 , ' show no residues of 90~ TCDD in 103 samples of mother's milk collected from women living in the forestry use areas of the Pacific Northwest. Analyses of human urine for residues of 2,4,5-T and silvex show no detectable residues in the vast majority of samples tested. In conjunction with HEWs Health and Nutri- tion Survey II (HANES II) study, EPA analyzed 1085 human 67/ Despite Dow's long-standing Freedom of Information Act and discovery requests for documents related to the mother's milk study, EPA still has provided few data to Dow. Instead, EPA announced the results of this study in a press release on January 15. Because of OGC's continued failure to provide Dow with this and other data, Dow is unable to supply further details concerning the mother's milk study in this brief. �- 34 - urine samples for 2,4,5-T and silvex, finding only four quantifiable silvex residues at low parts per billion levels. Trace findings of 2,4,5-T in 3 samples, and of silvex in 13 samples, all close to the level of detection, are uncertain.—' Thus, monitoring programs show no significant concentrations of 2,4,5-T, silvex, and TCDD in human urine and mother's milk. The overall potential for human exposure to these compounds is extremely slight, with the only detected concentrations at low parts per billion levels for 2,4,5-T and silvex, and very low parts per trillion levels for TCDD. IV. THE THEORETICAL CARCINOGENIC RISK POSED BY 2,4,5-T AND SILVEX PRODUCTS CONTAINING TCDD IS EXTREMELY SMALL, AND WELL WITHIN ACCEPTABLE LIMITS. Extensive experimental data show that "pure" 2,4,5-T and silvex are not carcinogenic in laboratory animals. Indeed, no increased carcinogenic response is observed in test animals even with technical grade 2,4,5-T and silvex 68/ Additional analyses of human samples for 2,4,5-T and sTlvex have been performed by Dr. Ralph Dougherty at Florida State University. Because critical aspects of Dougherty's work, including even summaries of a seven-year screening program, have not yet been produced in discovery, Dow has been unable to evaluate the few results reported by Dr. Dougherty. But significantly, EPA contractor Clement Associates, Inc. pointed out that one critical study by Dougherty "lacks credibility because the analysis was faulty." See Nisbet, I.C.T. et al., "Exposure, Toxicity, and Risk Assessment of 2,4,5-T/TCDD," Clement Associates, Inc. EPA Contract No. 68-01-5095 at 1-57 (May 15, 1979). �- 35 - containing measurable levels of TCDD. Thus, there is no direct experimental evidence that 2,4,5-T and silvex products are carcinogenic. TCDD administered to rats at relatively high levels in the diet produces an increase in liver, lung, and hard palate tumors, although no increased carcinogenic response is observed at lower doses. While a carcinogenic threshold, or no-effect level, may well exist for TCDD, the potential » risk posed by TCDD is extremely small, even assuming that no threshold exists. Quantitative risk assessments for potential dietary exposure to TCDD, as well as the theoretical risk posed by direct exposure to 2,4,5-T or silvex containing current levels of TCDD, show risks well within the range normally considered acceptable by EPA and other federal regulatory agencies. Indeed, the potential risks posed by direct or indirect exposure to TCDD are insignificant compared to other carcinogenic risks routinely accepted by society. Finally, long-term epidemiological studies fail to demonstrate increased carcinogenic risk for manufacturing workers accidentally exposed to very high levels of TCDD. A. 2,4,5-T and Silvex Produce No Measurable Carcinogenic Effects in Test Animals. Extensive carcinogenicity testing with 2,4,5-T and silvex fed to mice and rats shows no carcinogenic effects, even with TCDD concentrations well above those found in presently available commercial products. �- 36 - Early in 1979, EPA's Carcinogen Assessment Group (GAG) reviewed the available data on 2,4,5-T and concluded: "On the basis of the completed mice and rat studies, there is no significant evidence of carcinogenicity for 2,4,5-T, but the testing has not been done adequately in mice."2^/ The CAG based its conclusions on the Dow two-year feeding study in rats and on seven studies completed in mice.-^' The Scientific Advisory Panel concurred in the CAG's evaluation, finding that the studies in mice "have notr demonstrated a carcinogenic risk from commercial 2,4,5-T in this rodent species. "•£=•' The Panel also reviewed and approved Dow's two-year feeding study with specially purified 2,4,5-T', finding that "2,4,5-T . . . essentially free of contaminating TCDD, is not oncogenic in rats."^=/ Similarly, the Panel found that studies with commercial silvex in both 69/ CAG, "Risk Assessment on 2,4,5-T and TCDD" at 2 (February 23, 1979). This CAG position was stated approximately a year ago. Despite Dow's repeated efforts to obtain through discovery documents pertaining to CAG's latest work concerning 2,4,5-T, silvex, and TCDD, OGC has produced very little of value. Accordingly, Dow is unable fully to address the CAG's most recent work in this brief. 707 CAG explicitly rejected the statistical increase in tumors reported in one 1976 study, which suffered from severe methodological deficiencies and was not confirmed even by other studies performed by the same researchers, stating that "CAG cannot regard the study as furnishing significant evidence for the carcinogenicity of 2,4,5-T." CAG, Response to Rebuttal Comments on Risk Assessment of 2,4,5-T and TCDD" at 2 (April 4, 1979). 71/ SAP Report, Appendix I at 1-2. 72/ SAP Report, Appendix I at 2. �- 37 - mice and rats "did not indicate an increase in oncogenicity as a result of chronic exposure to silvex." The most comprehensive studies with 2,4,5-T are the two-year feeding study with rats performed by Dow researchers, using specially purified 2,4,5-T containing less than 0.0003 ppm TCDD,^—' and a similar two-year feeding study in rats performed in Hamburg, Germany, using technical grade 2,4,5-T containing 0.05 ppm TCDD.-^ These studies showed no carcinogenic effects at any level. Because of the theoretical risk posed by the minute quantities of TCDD present in commercial 2,4,5-T and silvex, the Scientific Advisory Panel considered the results of the German study especially important, and recommended that the "full details" of'that study be "obtained and evaluated."^/ The Panel was advised of preliminary results indicating "no • increase in tumors relative to the control groups," but recognized that "until the pathological examination is complete no definitive conclusion can be drawn relative to the oncogenic potential of commercial 2,4,5-T in rats."-^/ 737 Kociba, R.J. et al., "Results of a Two-Year Chronic Toxicity and Oncogenic Study of Rats Ingesting Diets Containing 2,4,5-T," Fd. Cosmet. Toxicol. 17 at 504-521 (1979). 74/ Leuschner, F., et al., "Chronic Oral Toxicity of 2,4,5-T, Batch No. 503, Control No. 153574b - Called for Short '2,4,5-T1 - In Sprague-Dawley (SIV 50) Rats," Laboratorium Fur Pharmakologie Und Toxikologie .(Unpublished) (April 9, 1979). 757 SAP Report at 2. 767 SAP Report, Appendix I at 2. �- 38 - The full results of the German study are now available and confirm preliminary reports of no increased cancer incidence. Along with other studies of commercial 2,4,5-T and silvex containing even higher concentrations of TCDD, it demonstrates that the theoretical risk posed by TCDD contamination in 2,4,5-T and silvex does not produce an observable increase in carcinogenic response. B. TCDD Produces Observable Carcinogenic Effects Only at Relatively High Doses Producing General Toxicity. Unlike 2,4,5-T and silvex, TCDD produces increased carcinogenic response in laboratory animals at relatively high dose levels which cause general toxicity in the animals. At lower doses, no increase in the incidence of cancer has been observed. The' Scientific Advisory Panel reviewed all available carcinogenicity evidence regarding TCDD, and concluded that "there is a level of TCDD below which no oncogenic or tumorigenic effects were seen in either mice or rats."—' The Panel evaluated and confirmed results reported in Dow's two-year feeding study in rats,—' which show an increase in tumors of the liver, lung, and hard palate tissues only at the highest TCDD dose; increased hyperplastic 77/ SAP Report, Appendix I at 7. 78/ Kociba, R.J. et al., "Results of a Two-Year Chronic Toxicity and Oncogenic Study of Rats Ingesting Diets Containing 2,4,5-T," Fd. Cosmet. Toxicol. 17 at 504-521 (1979). �- 39 - nodules of the liver at the middle dose; and no carcinogenic 79/ response at the lowest dose.—7 One member of the Panel, a pathologist, reviewed selected tissue slides from the study and reported that "the group at Dow extensively and properly surveyed the evidence of hepatocellular disease . . . . I am very comfortable with their evaluation for toxic injury and carcinogenesis. "—' The Panel questioned EPA's attempt to characterize the middle-dose liver nodules as precusors to cancer,s=/ and noted the Carcinogen Assessment Group's agreement that no oncogenic response occurred at the lowest dosa.22/ The Panel also reviewed a Hungarian study of TCDD in mice, concluding that there was no increase in tumor formation at the lower of two weekly doses and at a higher daily dose which shortened the life span of the mice. At other dose levels, the Panel found the data "insufficient to reach a 79/ SAP Report, Appendix I at 6-8. EPA's Carcinogen Assessment Group has also described the Kociba (Dow) study as "well-conducted." 80/ Edward Smuckler, M.D., Ph.D., "A Selected Review of the Histology of the Dow TCDD Study" (August 15, 1979), printed as Appendix II to the SAP Report. 81/ SAP Report, Appendix I at 6. Dr. Smuckler reported that "The midrange dose shows hyperplastic nodules, the remaining changes were identical with the high dose, but these slides did not show a carcinoma." Appendix II at 3 (emphasis added). 82/ SAP Report, Appendix I at 8. �- 40 - firm conclusion regarding whether there was a true oncogenic response."22/ The third available carcinogenicity study with TCDD is the highly questionable Van Miller-Allen study in SpragueDawley rats. The severe deficiencies in this study, first confirmed in an EPA laboratory audit,—' led EPA's Carcinogen Assessment Group to reject the claimed results at the lower dose levels.^/ As set forth in Dow's report to the Panel, » the Van Miller-Allen data — if valid for any purpose — show increased carcinogenesis only at the highest dose level, and provide no reliable evidence of increased cancer at lower doses.—' 837 SAP. Report, Appendix I at 7. See, Toth, K. et al., "Carcinogenicity Testing of Herbicide 2,4,5-TrichloropEenoxyethanol Containing Dioxin and of Pure Dioxin in Swiss Mice," Nature 278 at 548 (1979). 84/ Memorandum from H.W. Spencer and William Woodrow to Diana Reisa and Harvey Warnick, "TDAP Review at University of Wisconsin, TCDD in Rats" (February 8, 1979). 857 EPA, "Decision and Emergency Order Suspending Registrations for the Forest, Rights-of-Way, and Pasture Uses of 2,4,5-T," 44 Fed. Reg. 15874, 15880, note (March 15, 1980). 86/ Dow presently seeks discovery of documents and records related to the Van Miller-Allen study and has previously detailed the known errors and defects in this study in Dow's Report to the Scientific Advisory Panel, as well as discovery pleadings filed in this case. See, The Dow Chemical Company's Report to the FIFRA Scientific Advisory Panel on 2,4,5-T and Silvex at 10-15 (August 6, 1979) (filed in these proceedings on August 16, 1979); see also, e.g., Supplemental Memorandum in Support of Compulsory Document Discovery at 16-20 (filed January 14, 1980). �- 41 - The data concerning TCDD suggest a carcinogenic mechanism which operates only above a threshold level. But even assuming the conservative "no-threshold" model, extrapolations of the animal test data on 2,4,5-T show that the potential human cancer risk for exposure to TCDD through food and water, or through 2,4,5-T and silvex containing TCDD, is extremely slight. C. Quantitative Risk Assessments Demonstrate That the Small Theoretical Risk Posed by Trace Amounts of TCDD in 2,4,5-T and Silvex Products Is Well Within Acceptable Limits. Quantitative risk assessments using the most conservative methods, as well as conservative assumptions regarding potential TCDD exposure, show extraordinarily low risks for members of the general public and extremely low risks for pesticide» applicators, all of which are acceptable under regulatory standards used by EPA and other agencies. For example, risks are significantly lower than cancer risks accepted for other carcinogens such as aflatoxin, found in peanut butter, milk, and other foodstuffs, and lower than other commonplace carcinogenic risks found acceptable by society. The Scientific Advisory Panel found that the available monitoring data "does not suggest that TCDD derived from commercial 2,4,5-T and silvex exhibits any tendency to accumulate in the food chain in amounts which would pose a �- 42 - substantial risk,"2-/ and found that the "potential oncogenic risk" from TCDD in the food chain "is judged to be small.»5S/ The Panel's "extreme worst case" calculations show a lifetime carcinogenic risk of only four tumors for every one million persons exposed,—-' based on what the Panel described as an "extreme exaggeration" of dietary exposure to TCDD.—' Similar risk calculations based on more realistic, but still conservative, figures for potential dietary exposure » to TCDD show risks substantially below the "extreme worst case" assessment performed by the Scientific Advisory Panel. As with potential dietary exposure risks, the risks calculated for applicators, and for bystanders accidentally sprayed directly in aerial operations, are extremely low. Based on the actual direct exposure data developed in the Lavy-Ramsey study, the risk even for a pesticide mixer (the most exposed applicator) working for a full career is extremely low. The risk for an incidental bystander — even if sprayed repeatedly — is infinitesimal. The risk assessment performed by the Scientific Advisory Panel, and the others discussed above, all employ the "linear one-hit" model for estimating carcinogenic risk, the most 877 SAP Report, Appendix I at 8. 88/ SAP Report, Appendix I at 9. 897 SAP Report, Appendix I at 8-9. 907 SAP Report, Appendix I at 10. �- 43 - conservative feasible model for such assessments. In the few instances where sufficient human data are available to check linear one-hit risk estimates based on animal tests, this model has overestimated the real incidence of tumors by many orders of magnitude. Calculations of risk for TCDD based on other commonly accepted risk assessment models, show even lower risk estimations for dietary and direct exposure. * Even the regulation of known carcinogens in foodstuffs involves application of the "acceptable risk" concept. For example, aflatoxin, a carcinogen roughly equivalent in potency to TCDD when calculated on an absolute dose basis, i-s Permitted by FDA regulation in foods such as peanut butter and milk at concentrations of from 0.5 ppb to 20 ppb—' — a level much higher than any potential exposure to TCDD. A person who drinks one pint of milk per day, or who eats an average four tablespoons of peanut butter per day, incurs an annual cancer risk from aflatoxin higher than the cancer risk for the most heavily exposed pesticide applicator.-—' TCDD risks are also lower than many other commonplace cancer risks, such as those posed by living in Denver as compared 91/ 21 C.F.R. § 50.285. 927 See The Dow Chemical Company's Report to the FIFRA Scientific Advisory Panel on 2,4,5-T and Silvex, Table IV-F (August 6, 1979) (filed in these proceedings on August 16, 1979) (calculations of commonplace cancer risks, prepared by Dr. Richard Wilson, Director of Harvard University's Energy and Environmental Policy Center). �- 44 - to New York (high altitude exposure to cosmic rays), or by average diagnostic medical X-rays in the United States 93/ (radiation).—' D. Long-Term Epidemiclogical Evidence Fails to Show Increased Carcinogenic Risk From High TCDD Exposure. Despite certain inherent limitations, epidemiological / data derived from actual instances of human exposure can provide extremely useful data which both sets an "upper limit" on risk, and confirms other assessments of risk. Problems not generally encountered in laboratory studies, such as uncontrollable confounding factors, the difficulty of assessing actual exposure levels, and frequent problems with incomplete data collection, render it difficult to * prove with epidemiologic evidence that a specific effect is attributable to a particular substance. Because of the long latency period for carcinogenic effects in humans, epidemiological studies of carcinogens must include data over several years. Studies of two acci- dental industrial exposures at manufacturing plants in the United States, in 1949 and 1964, show no increased incidence of cancer among workers exposed to levels of TCDD sufficient to produce chloracne in most of those exposed — a level of 93/ Id. �- 45 - TCDD exposure far beyond that which could occur today in pesticide applicators or the general public.—/ A recently completed study of workers exposed to TCDD in a 1949 accident at the Nitro, West Virginia Monsanto Chemical Plant followed the health of 121 workers, all exposed heavily enough to develop chloracne, a skin condition which is a hallmark sign of TCDD exposure.^/ The Nitro researchers concluded that "the analysis of the mortality experience of these workers indicated no apparent excess of total mortality or deaths due to malignant neoplasms or circulatory diseases."^/ In fact, mortality among these workers was below that of the general population. Similar results were obtained in an epidemiological investigation of Dow workers in a trichlorophenol plant, many of whom developed chloracne when accidentally exposed * to TCDD at some time between December 1963 and December 94/ OGC's December 17 witness and exhibit list adds several new epidemiological studies from Scandinavian countries, translations of which have only recently been transmitted to Dow. Although these data have not yet been fully reviewed, they appear questionable both because of the presence of confounding exposures to chemicals other than 2,4,5-T, and because they contradict the conclusions of other European and American studies which uniformly fail to demonstrate any increased cancer incidence associated with exposure to TCDD, 2,4,5-T, or indeed phenoxy herbicides as a class. 95/ Zack, J.A. and R.R. Suskind, "The Mortality Experience of Workers Exposed to Tetrachlorodibenzodioxin in a Trichlorophenol Process Plant," In Press (1979). 96/ Id. at 11. �- 46 - 1964.—' In addition, epidemiologic study of workers in Dow's 2,4,5-T plant shows no increased cancer mortality.^/ The workers examined in the Monsanto study and in the Dow trichlorophenol plant study were exposed to TCDD at concentrations far higher than those encountered by the most heavily exposed applicators today, and have suffered no excess incidence of cancer in 15 and 30 years, respectively. Accordingly, if the minute quantities of TCDD contained in 2,4,5-T and silvex products present any carcinogenic risk -at all, such risk must be extremely low. V. 2,4,5-T AND SILVEX PRODUCTS PRESENT NO REPRODUCTIVE RISK TO HUMANS UNDER CURRENT USE PRACTICES. The Agency has based its contentions on reproductive risk on a series of unscientific theories, each of which has been thoroughly discredited in its turn. The Alsea II study — cornerstone of the March suspension and cancellation orders — stands universally condemned by the scientific community. The Scientific Advisory Panel thoroughly refuted the Agency's July contentions set forth in the Section 6(b)(2) position documents, that no-effect levels have not been established for reproductive effects. 97/ Ott, M.G., "A Followup Study of Health Exam Parameters and Mortality on 61 Employees Presumably Exposed to TCDD in a Trichlorophenol Process During 1964," Unpublished, The Dow Chemical Company (1974) (Confidential). 98/ Ott, M.G.,et al., "A Longevity Survey of Employees Exposed to 2,4,5-T" (Unpublished), The Dow Chemical Company (1978) (Confidential). �- 47 - At present, OGC's case is based largely on the highly questionable work performed by Dr. Allen, and on the hope that new evidence will establish the adverse effects which the Agency repeatedly has alleged. Contrary to the Agency's contentions, however, no-effect levels are firmly established for 2,4,5-T, silvex, and TCDD. And, because potential exposure levels are far below these no-effect levels, 2,4,5-T, silvex, and TCDD present no • fetotoxic or teratogenic risk to humans. A» EPA's Alsea II Study Supplies No Evidence Whatsoever of Adverse Reproductive Effects in Humans. As. set forth in Part I of this memorandum, the Alsea II study on which EP.A based the rash "emergency" suspension orders has been thoroughly discredited in every scientific review conducted since its surprise publication in March, 1979. Reviewing bodies including the Environmental Health Sciences Center at Oregon State University, at least three foreign governments, a June scientific conference on 2,4,5-T sponsored by the American Farm Bureau Federation, and an independent epidemiologist retained by Dow to review the study have all concluded that the claimed relationship between herbicide spraying and the rate of miscarriage is spurious and utterly unsupported by the Alsea II data.—' 99/ See pp. 7-9, supra. �- 48 - The severe deficiencies in study design and execution which render the Alsea II results meaningless are essentially of three types. First, the Agency's collection of data for herbicide spraying, for miscarriages, and for live births was grossly incomplete. - ' As Deputy Assistant Administrator Edwin Johnson admitted at the Scientific Advisory Panel hearings, the "hospitalized" miscarriage data used in Alsea II accounted for only ten to twenty percent of actual miscarSecond, the Agency failed to account for numerous confounding factors, such as differences in medical pratices among areas; the possibility of miscarriage-inducing disease due to unpasteurized milk, wild game, and untreated well-water, all known to be used in the Study area; sociological differences such as average maternal age among areas; and possible use of miscarriage-inducing drugs or native plants.-1027 Finally, the data actually collected were subjected to extensive and inappropriate statistical manipulations. The Alsea II researchers ignored the results of the appropriate statistical tests — all showing no relation between pesticide use and miscarriage — and through statistical sleight-of-hand, 100/ Oregon State Critique at 52, 15, and 20-23; Lamm, S.H., "An Epidemiologic Assessment of the Alsea II Report", at 6-12 (August 6, 1979) (hereinafter "Lamm Assessment"). 1017 SAP Tr. at 14 (August 15, 1979). 102/ Oregon State Critique at 16-20; Lamm Assessment at 6-12. �- 49 - converted a single group of 10 miscarriages in June 1976 into a complex seasonal pattern extending for six years. The Alsea II study simply is not sound scientific work, and the study fails to support any of the claims made by the Agency in March. The Agency's scant mention of Alsea II in its position documents issued this past summer=2i/ is tacit admission that Alsea II, which was the foundation for the March suspensions, is utterly worthless. * B. Weil-Established No-Effect Levels for 2,4,5-T, Silvex, and TCDD Show Substantial Margins of Safety for Applicators and the Public. Following the embarassing spectacle of Alsea II, OGC attempted to resurrect its case on reproductive effects through ill-conceived reinterpretations of the extensive t animal test data on 2,4,5-T, silvex, and TCDD. The allegations made by EPA in its proposed Section 6(b)(2) position documents, however, were discarded by the Scientific Advisory Panel following thorough review of the evidence. As shown below, no-effect levels have been established for 2,4,5-T, silvex, and TCDD in laboratory animals. These test data, in conjunction with the available data on potential human exposure, demonstrate broad margins of safety for 103/ Agresti, A., "Analysis of Association Between 2,4,5-T Exposure and Hospitalized Spontaneous Abortions," Supplement to a Scientific Critique of the EPA Alsea IIStudy and Report (November 16, 1979); Lamm Assessment at 12-18. 104/ EPA, "2,4,5-T: Position Document 2/3 "(July 9, 1979); EPA, "Silvex: Position Document 1/2/3" (July 9, 1979). �- 51 - in Dow's Report to the Scientific Advisory Panel.i2s/ AS set forth in the Report, various fetotoxic effects were observed at higher doses in many studies, but no-effect levels were established in most individual studies as well as collectively for every species.109/ Teratogenic effects ' were observed in mice, a species particularly susceptible to such effects.^i^/ In long-term reproduction studies, the Scientific • Advisory Panel explicitly stated that Dow's three-generation study in rats establishes a no-effect level of 3 mg/kg/day,=-=/ which should be used for evaluating the risk of long-term chronic exposure. In light of the no-effect levels recognized by the Scientific Advisory Panel, the extremely low potential for human exposure to 2,4,5-T or silvex through residues in food, water, or other environmental substrates presents no reproductive risk to humans. Indeed, on the ultimate issues posed by the Agency, the Panel determined that residues and potential exposure from the nonsuspended uses do not even 1127 suggest "the possibility of significant risk."^^^ 1087 Dow Report at 23-26 (2,4,5-T); 28-29 (Silvex). 1097 Dow Report at 24 (2,4,5-T); 28-29 (Silvex). 1107 Dow Report at 25 (2,4,5-T); 28-29 (Silvex). 1.117 SAP Report, Appendix I at 4. 1127 SAP Report at 6. �- 52 - Even for applicators with direct daily exposure, the Panel found only a "potential" for reproductive risk, and determined that such risks would be acceptable with the use of simple protective clothing.==^/ Even without such protective clothing, however, substantial safety margins exist for all applicators, including those with the highest measured exposures.i=z/ The Panel concluded that the potential reproductive » risk to those living in the immediate spray area "does not appear to be substantial, except as they may be directly exposed on a chronic basis."==§/ The calculated margin of safety for an individual accidentally sprayed in a single aerial pass is 80,000.==^ Thus, 2,4,5-T and silvex pose no teratogenic or fetotoxic risk to ^the general population or to pesticide applicators. Broad margins of safety exist for all individuals, including the most highly exposed applicators. 2. TCDD. EPA's July Section 6{b)(2) proposals, as well as the final 6(b)(2) notices issued in December, depend critically 113/ SAP Report, Appendix I at 4 (2,4,5-T); Appendix I at 5 TsTlvex). 1147 Dow Report at 64 and Table IV-A. 1.15/ SAP Report, Appendix I at 4 (2,4,5-T) (emphasis added). See SAP Report, Appendix I at 5-6 (Silvex). 116/ Dow Report at 64. �- 53 - on the Agency's contentions that no-effect levels have not been established in Dow's three-generation reproductive study with TCDD in rats, and in Dr. Allen's studies of TCDD in monkeys. The Scientific Advisory Panel expressly rejected the Agency's tortured construction of the data from the Dow rat study, and suggested that an equivalent no-effect level might be found in the 25 ppt Allen monkey study. / The Panel expressly recognized no-effect levels for TCDD in mice, rats, and monkeys for short-term teratology studies.==2/ The results of these studies, showing no- effect levels for all species and no teratogenic effects in species other than mice, are set forth in Dow's Report to the Panel.ii^/ Evaluating EPA's contentions with respect to the lowest dose level in Dow's three-generation rat study, the Panel • rejected the Agency's reliance on isolated data "suggestive" of embryotoxicity, concluding that "the inconsistency of the effects from generation to generation and in relation to the higher dose . . . suggests that the 0.001 mg/kg/day dose is 1197 for all practical purposes a no-effectlevel."==^/ signifi- cantly, one of the Agency's key witnesses on reproductive 117/ SAP Report, Appendix I at 9. 1187 Dow Report at 30-31. 1197 SAP Report, Appendix I at 9-10 (emphasis supplied) �- 54 - effects, Dr. Diane Courtney, conceded almost as much in her testimony before the Panel. =•=-/ The remaining leg of OGC's argument regarding no-effect levels for TCDD depends on the reproduction studies in monkeys conducted at the University of Wisconsin by Dr. James Allen and his associates. As set forth in pleadings already filed in these proceedings, Dr. Allen's work with TCDD is subject to serious question. ==•=/ EPA's own laboratory auditors have criticized severely Dr. Allen's laboratory* practices,==!/ and the Agency's Carcinogen Assessment Group has rejected much of the reported results of his carcinogenicity study in rats.===/ If this were not enough, tissues taken from Dr. Allen's 500 ppt monkeys were found to contain high levels of toxic PCBs, suggesting serious cross-contamination in Dr. Allen's laboratory.-124/ • The Scientific Advisory Panel strongly recommended that the full details of Dr. Allen's 25 ppt monkey study be 120/ SAP Tr. at 20 (September 20, 1979) ("I don't doubt that we are close to a no-effect level, and it isn't going to take much"). 121/ See, e.ff., The Dow Chemical Company's Reply to Respondent's Opposition to Dow's Motion to Compel Discovery (filed January 8, 1980); Supplemental Memorandum in Support of Compulsory Document Discovery (filed January 14, 1980). 1227 Memorandum from H.W. Spencer and W. Woodrow to Diana Reisa and Harvey warnick, "TDAP Review at University of Wisconsin, TCDD in Rats" (February 8, 1979). 1237 EPA "2,4,5-T Decision and Emergency Order Suspending Registrations for Certain Uses," 44 Fed. Reg. 15874, 15880 (March 15, 1979). 124/ Letter from R.J. Kociba to John Van Miller (May 8, 1978). �- 55 - 125 "obtained and evaluated, "±=^/ and observed that "[i]f no reproductive toxicity is seen in the monkeys exposed to TCDD in the diet at 25 ppt, then the no effect level in the monkey will be similar to that seen in the rat. "==•£/ Thus, there is good reason to believe that a no-effect level will be established for monkeys. Based on the no-effect level established in the Dow three-generation rat study, and exposure assumptions repre• senting an "extreme exaggeration of exposure to TCDD," the Panel calculated a safety margin of approximately 500 for "worst case" dietary exposures to TCDD.==^/ Thus, the Panel concluded that "the current monitoring data do not indicate that there is a substantial reproductive or teratogenic risk • 128 posed by the accumulation of TCDD in the human food chain."==£/ Calculated safety margins for TCDD are very high for applicators exposed to 2,4,5-T or silvex on a daily basis, and are extraordinarily high for accidentally sprayed bystanders, due to the minute concentrations of TCDD found in 2,4,5-T. For example, even assuming a TCDD concentration of 0.05 ppm — twice the highest concentration detected by EPA .1297 in recent tests of commercial 2,4,5-T and silvex samples^ 1257 SAP Report at 2. 126/ SAP Report, Appendix I at 10. 1277 Id. 1287 SAP Report, Appendix I at 10-11. 1297 2,4,5-T Position Document 2/3 at 8, note (July 9, 1979); Silvex Position Document 1/2/3 at 9, note (July 9, 1979). �- 56 - — mixers have a safety margin of 8,200, and bystanders a safety margin of 2,400,000 for TCDD.;1307 Accordingly, TCDD poses no fetotoxic or teratogenic risk to humans, including applicators exposed daily to 2,4,5-T or silvex at current levels of TCDD. C. Data Generated Following the Seveso Accident Confirms the Absence of Reproductive Risk From TCDD Exposure. Despite the limitations which often attend epidemiological studies,isi/ observations made in Seveso, Italy and surrounding areas following a 1976 industrial accident provide important evidence confirming the absence of reproductive risk from the minute TCDD exposures which might result from herbicide use. At Seveso, the general population was exposed to high levels of TCDD produced in the explosion of a reactor used to produce sodium trichlorophenate. Extensive health monitoring programs instituted by Italian authorities demonstrate no confirmed increase in adverse reproductive effects, even at exposure levels sufficient to produce chloracne. While reported levels of birth defects at Seveso increased slightly following the accident, no unusual pattern of defects was observed, and researchers have attributed the increase to the mandatory government health surveillance 130/ See Dow Report at 64-66 1317 See p 44, supra. �- 57 - 1327 system initiated after the accident.=—=/ NO significant increase could have occurred, as the rates for the Seveso contamination zones are consistent with the average reported for all occidental countries and for the Milan region.133/ =—' The absence of excess birth defects is consistent with laboratory analyses, showing no indication of mutagenic, teratogenic, or fetotoxic effects. Reported miscarriage rates also increased following the accident, again probably due to the mandatory health statistics reporting system, but appeared to be unrelated to levels of TCDD contamination in the area.=^/ The miscarriages were within the expected 15% to 25% incidence of miscarriage worldwide, strongly suggesting that no real increase occurred.*^/ The Seveso data demonstrates that high environmental * concentrations of TCDD producing mild toxicity (chloracne) 132/ Homberger, E., et al., "The Seveso Accident: Its Nature, Extent & Consequences, "Givaudan Research Co., Ltd. (Unpublished) (1979). 133/ Tuchmann-Duplessis, H., "Pollution of the Environment and Offspring Apropos of the Accident of Seveso," Medecine, et al. Hygiene 3_6 at 1758-66 (1978). 134/ Bisanti, L., et al., "Experiences of the Accident of Seveso," European Teratology Society, 6th Conference, September 4-7, 1978, published by Akademiai Kiad<l>, Budapest at 11 (1979). 1357 Homberger, E., et al., "The Seveso Accident: Its Nature, Extent and Consequences," Unpublished (1979); Tuchmann-Duplessis, H., "Pollution of the Environment and Offspring Apropos of the Accident of Seveso," Medecine et Hygiene 36 at 1758-66 (1978). �- 58 - in the population do not produce any significant increase in the incidence of birth defects or miscarriages, and that humans are less sensitive to TCDD than are laboratory animals. While environmental concentration and exposure data from Seveso are not precise, the doses to which the Seveso population were exposed are many orders of magnitude higher than the environmental residues or human exposure levels which might result from the use of 2,4,5-T and silvex at current * levels of TCDD. Accordingly, the Seveso observations strongly confirm the extensive evidence showing that TCDD from herbicide use poses no adverse reproductive risk to humans. CONCLUSION As shown above, there is no scientific basis for any regulatory action concerning 2,4,5-T and silvex, much less the severe and unprecedented "emergency" suspension orders issued in March. OGC's intransigent refusal to acknowledge the safety of these useful products, despite the universal scientific rejection of the Alsea II study on which the suspensions were based and despite the Scientific Advisory Panel's utter rejection of OGC's subsequent theories regarding the risk evidence, conflicts sharply with responsible scientific opinion, 'with the actions of other governments, and with EPA's own regulatory practices. The 1971 National Academy of Sciences Committee, the 1974 Scientific Workshop on 2,4,5-T, the 1979 Scientific �- 59 - Dispute Resolution Conference, and EPA's own Scientific Advisory Panel have found no reason whatsoever to curtail or eliminate the use of these pesticides. Indeed, the Scientific Advisory Panel, after a comprehensive review of the Agency's position and the relevant scientific data, concluded that these hearings should not even be held. Similarly, Great Britain, Australia, and New Zealand have considered and rejected EPA's position in reviews conducted after the March » suspension actions. OGC's contentions regarding 2,4,5-T and silvex represent an extraordinary aberration in EPA's overall regulatory program. Even the extremely conservative analysis favored by OGC, including the no-threshold linear model for carcinoV genesis, "worst case" exposure calculations, and the use of high margins of safety — all of which are designed to account for any uncertainties in the available data — shows an extremely low potential risk from 2,4,5-T and silvex. EPA, as well as other federal agencies, routinely approve the use of other substances known to entail far greater risk. In short, the use of 2,4,5-T and silvex presents no unreasonable risk to man or the environment. Accordingly, �t. v>- - 60 - all registered uses should be restored and continued as required by law. Respectfully submitted, Edward W. Warren L. Mark Wine Richard L. McConnell John A. Zackrison KIRKLAND & ELLIS 1776 K Street, N.W. Washington, D.C. 20006 (202) 857-5000 Of Counsel: John Scriven Mark Tucker Dow Chemical U.S.A. 2030 Dow Center Midland, Michigan 48640 Rudolf H. Schroeter LA FOLLETTE, JOHNSON, SCHROETER, & DE HAAS 320 North Vermont Avenue Los Angeles, California 90004 Counsel for The Dow Chemical Company January 25, 1980 �CERTIFICATE OF SERVICE I HEREBY CERTIFY that copies of The Dow Chemical Company's Pretrial Risk Brief were delivered by hand or mailed first class postage prepaid on January 25, 1980, to the persons on the attached list. L. Mark Wine � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 182 Folder The folder containing the original item. 5307 Series The series number of the original item. Series VIII Subseries I Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Warren, Edward W. Description An account of the resource <strong>Corporate Author: </strong>Dow Chemical Company Date A point or period of time associated with an event in the lifecycle of the resource January 25 1980 Title A name given to the resource Before the Environmental Protection Agency (EPA) of the United States of America, In re: The Dow Chemical Company, et al., Docket Nos. 415, et al., The Dow Chemical Company's Pretrial Risk Brief ao_seriesVIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 192 Folder The folder containing the original item. 5420 Series The series number of the original item. Series VIII Subseries I Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Bryan, C. D. B. Source A related resource from which the described resource is derived The New Republic Date A point or period of time associated with an event in the lifecycle of the resource June 27 1983 Title A name given to the resource Book Review: The Veterans' Ordeal: Waiting for an Army to Die: The Tragedy of Agent Orange by Fred A. Wilcox ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/de0f916645e7c96307809fc65d819fbb.pdf f1551fa1674a727207acfcaf5795bfa8 PDF Text Text Ken. D Number 05406 n NotScannad Author Corporate Author Roport/Artido TItlfl Bn e n ' fi 9 Book for HVAC Subcommittee on Compensation, Pension and Insurance Hearing on H. R. 1961, Veterans Agent Orange Relief Act, April 26 and 27,1983 and May 3, 1983 Journal/Book Title Year 1983 Month/Day Color Number of Images n ° Includes 24 sections with a table of contents. Section 16 material is missing. Friday, March 08, 2002 Page 5406 of 5427 �Briefing Book for HVAC Subcommittee on Compensation, Pension and Insurance Hearing on H.R. 1961, Veterans Agent Orange Relief Act. April 26 and 27, 1983 and May 3, 1983 Index Tab 1. Invitation Letter from Mr. Mongtomery to Mr. Walters, dated April 5, 1983 2. Formal Statement 3. H.R. 1961 and Agency Report, 4. Agent Orange Chronology 5. CDC Epidemiological Study - Background and Current Status 6. VA/CDC Interagency Agreement 7. CDC Epidemiological Study Protocol Outline 8. OTA Review of CDC Protocol Outline 9. CDC Resource Requirements 10. P.L. 97-72 Guidelines 11. Agent Orange Related Research Activities 12. Agent Orange Monthly Review - March 1983 13. Agent Orange Pamphlets and Newsletters 14. Agent Orange Registry Circulars 15. Agent Orange Claims Tally 16. Letter from Senator Cranston to VA re Change in Effective Date Legislation and VA Response (November 1981) 17. Letter from Senator Cranston re Complying with Intent of P.L. 97-72 for Radiation. 18. White Paper, Review of Chloracne Claims 19. White Paper, Chloracne and the Agent Orange Examination �20. White Paper, Epidemiology of Soft-Tissue Sarcoma and Related Human Research 21. White Paper, Porphyria Cutanea Tarda 22. White Paper, Times Beach/Vietnam? U^eme, \o A^a SW<et 23. Questions and Answers 24. Australian Government Statements i �MMOCMT* N1N6TY-HGHTM CONGRESS MfUtUCANS ,<*IY| MONTOOMmr, MCI JBIIII MM MAMMfRSCHMIOT, AKK. CHALMERS r. wnie. OHIO fcwooo HIUIS. IND 6. V. (SONNY) MONTGOMERY . •OOGLAI AWUOATf. OHIO MARVIN LtATH. TEX. WCHAM) C. »HEL»Y. ALA. OAN MICA. FU. MAS A. DASCHLE. I. DAK. " ~" iV. MISS. I/O. MARTINEZ CAW. NS. ILL I. OHIO N. PA. ALAN », MOU.OHAN, W, VA. TIMOTHY J. PENNY, MINN. MAULEY 0. STAGGERS. JH. W. VA, I, ROY ROWLAND, OA. JM SLATTtRY, KAN*. JOHN (MYANT. TEX •IU nCHAKOtON, N, MX OfRALO I H. SOLOMON. N.V. MM McEWtN. OHIO CMMSTOFHER H SMITH, N J. OiNHY SMITH. OMEC. OAN (URTOM. IND OOt* SUNDOLHST. nHN. MCHAEl (ILIftAKIS. FLA. NANCY LEI JOHNSON. CONN. . Jfrtufe COMMITTEE ON VETERANS' AFFAIRS »3S CANNON HOUSE OFFICE BUILDING Wflfi&ington, 3B.C. 20515 April 5, 1983 MACK FLEMING CMtF COUNSa AND «TAW MMCTO* ._ cn Honorable Harry Walters Administrator of Veterans' Affairs •Veterans' Administration Washington, D. C. 20420 s aci Dear Mr. Administrator: The Subcommittee on Oversight and Investigations requests your testimony at a hearing to be held on Tuesday, May 3, 1983 at 8:30a.m. in Room 334 of the Cannon House Office Building. The subject of the hearing is the status of Federally conducted Agent Orange studies. Additionally* it 1s requested that Doctor Donald L. Custis, Chief Medical Director, Dr. Barclay M. Shepard, Special Assistant to the Chief Medical Director for Environmental Medicine, and Major Alvin Young, Environmental Scientist, also be present at the hearing. The Subcommittee requests status summaries on the following studies or reports: mgdj^i art-inn^ taken recommendations made in GAP Repjart GAO/HRD-83-6 of October. 25, 19821 EPA/VA retrospective study of dioxins and furans Tri~adipose tissue of Vietnam veterans; Chloracne Task Force; twin study; mortality study; survey of patient treatment file for Vietnam veteran inpatient care, as well as an update of any private sector Agent Orange related studies with which the VA is affiliated or cognizant. The Subcommittee would greatly appreciate confirmation of your appearance (or that of your designee) at the earliest possible date, as well as the names and titles of those accompanying you in addition to the individuals listed in the first paragraph.' Any questions may be addressed to Barbara Daniel of the Committee staff at 225-3527. Please provide 85 copies of your prepared testimony to Mrs. Arlene Burnett in Room 335, Cannon House Office Building, by close of business on Friday, April 29, 1983. Sincere lojffi APR IS 1983 MONTGOMERY Chairman LEGISLATIVE AFFAIRS STAFF, �•onorable 6. ». (Sonny) ffoatgoaery Chairman, COM it tee on Veterans* Affair* louse of ftepresentatires Vaebingten, D.C. 20515 Pear Mr. Chairman* TaU will acknowledge rout recent lav 1 tat Ion to appear before th« fubeeaaitt** on Ovtraifht and ZnTaati^ationa at ita May 3 haariag en t»a ataiua «f fadarally eond«ctad Agant Oranga atodiaa. Tba Chief Medical Diraetor, Dr. Donald L, Custi«, will ba tba VA'a trltnart. Dr. C«atia vill ba accompanied by tba Acting Director of the Agent Orange Project! Office, Dr. Barclay M. Shepardi and Environmental ficiencea Specialitt, Agant Orange Frojecta Officer Dr. Alrin Tovng. Every effort vill be Bade to furnieh eighty-five copiea of oar prepared teatinony by April 29, ea requeated. Should that prove iKpoaaibler the General Cottneel'a Cffice vill promptly notify yocr ataff. Sincerely, BAKJtY ». WALTERS Adftiniatrator �1, MAY 3, 1983 MR, CHAIRMAN AND MEMBERS OF THE COMMITTEE: GOOD MORNING, WE ARE PLEASED FOR THE OPPORTUNITY TO APPEAR BEFORE YOU TODAY TO DISCUSS THE STATUS OF FEDERALLY-CONDUCTED AGENT ORANGE STUDIES, WITH YOUR PERMISSION, MR, CHAIRMAN, I WILL BRIEFLY SUMMARIZE THE FULL TEXT OF MY STATEMENT WHICH HAS BEEN SUBMITTED FOR THE RECORD, THE VETERANS ADMINISTRATION HAS UNDERTAKEN A NUMBER OF ACTIVITIES WHICH I THINK DEMONSTRATE OUR COMMITMENT AND RESOLVE TO ADDRESS THE CONCERNS RAISED BY OUR VIETNAM VETERANS, WHEN THE CONTROVERSY FIRST AROSE IN 1978, WE INITIATED A PROGRAM OF OFFERING A FREE EXAMINATION TO ANY VIETNAM VETERAN WHO IS CONCERNED ABOUT THE POSSIBLE HEALTH EFFECTS OF EXPOSURE TO AGENT ORANGE, A VETERAN COMING TO THE VA UNDER THIS PROGRAM RECEIVES A THOROUGH PHYSICAL EXAMINATION WITH ALL APPROPRIATE LABORATORY TESTS, THE RESULTS OF THE E X A M I N A T I O N ARE DISCUSSED WITH THE VETERAN PERSONALLY AND BASIC I N F O R M A T I O N C O N C E R N I N G THE HEALTH STATUS OF THE V E T E R A N IS ENTERED INTO THE COMPUTERIZED AGENT O R A N G E REGISTRY, THE M A I N PURPOSE OF THE REGISTRY IS TO P R O V I D E A SYSTEMATIC WAY TO IDENTIFY CONCERNED V I E T N A M V E T E R A N S AND TO ASSIST WHETHER THERE ARE ANY S I G N I F I C A N T HEALTH DATE, OVER 106 THOUSAND THIS PROGRAM, IN D E T E R M I N I N G TRENDS A M O N G THEM, TO V E T E R A N S HAVE R E C E I V E D E X A M I N A T I O N S UNDER �2, WITH THE ENACTMENT OF PUBLIC LAW 97-72, THE VETERANS ADMINISTRATION WAS AUTHORIZED TO PROVIDE COMPREHENSIVE HEALTH CARE TO VETERANS FOR CONDITIONS THAT MAY BE ASSOCIATED WITH EXPOSURE TO DIOXINS CONTAINED IN HERBICIDES IN VIETNAM OR TO IONIZING RADIATION FROM ATOMIC WEAPONS TESTING OR AS A RESULT OF SERVICE WITH OCCUPATION FORCES OF HIROSHIMA AND NAGASAKI, APPROXIMATELY 12 THOUSAND VETERANS WERE ADMITTED FOR CARE DURING THE PERIOD FEBRUARY 1982 TO FEBRUARY 1983 AND THERE WERE APPROXIMATELY W THOUSAND OUTPATIENT VISITS TO VA HEALTH CARE FACILITIES, WHILE WE ARE ATTEMPTING TO MEET THE IMMEDIATE HEALTH CARE NEEDS OF VIETNAM VETERANS, WE CONTINUE TO EXPLORE EVERY APPROACH AVAILABLE THAT WILL ASSIST US IN PROVIDING UP-TO-DATE TECHNICAL INFORMATION FOR OUR HEALTH CARE STAFF, A SERIES OF SCIENTIFIC MONOGRAPHS WRITTEN BY RECOGNIZED EXPERTS IN THEIR RESPECTIVE FIELDS ARE BEING PREPARED ON THE TOPICS OF AGENT BLUE, BIRTH DEFECTS, GENETIC SCREENING AND COUNSELING, HUMAN EXPOSURE TO PHENOXY HERBICIDES, AND CHLORACNE, WHEN COMPLETED, THESE MONOGRAPHS WILL BE WIDELY DISTRIBUTED BOTH WITHIN AND OUTSIDE THE VETERANS ADMINISTRATION, ACCOMPANYING THIS EFFORT WILL BE AN UPDATE OF THE REVIEW OF THE LITERATURE ON HERBICIDES THAT WAS COMPLETED IN 1981, THE VETERANS ADMINISTRATION HAS BEEN MANDATED TO PERFORM AN EPIDEMIOLOGICAL STUDY OF VETERANS WHO WERE EXPOSED IN VIETNAM TO DIOXINS CONTAINED IN HERBICIDES USED IN VIETNAM, OBJECTIVITY CREDIBILITY, VETERANS AND THE TO ENSURE ADMINISTRATION CONTRACTED WITH UCLA TO DEVELOP THE STUDY'S PROTOCOL AND ASKED NON- �3, VA EXPERTS TO REVIEW IT, WHEN CONCERNS WERE RAISED AND QUESTIONS STILL REMAINED ABOUT THE CREDIBILITY OF A VA-CONDUCTED STUDY, THE VETERANS ADMINISTRATION ASKED THE CENTERS FOR DISEASE CONTROL TO UNDERTAKE THE DESIGN AND CONDUCT OF THE STUDY, THE CDC WILL HAVE COMPLETE INDEPENDENCE IN THIS EFFORT, WHICH IS EXPECTED TO TAKE A NUMBER OF YEARS TO COMPLETE, COMPLEMENTING THE EPIDEMIOLOGICAL STUDY, ARE A NUMBER OF OTHER VETERANS ADMINISTRATION INITIATED STUDIES THAT SHOULD YIELD RESULTS IN A SHORTER TIME FRAME, THESE ARE A MORTALITY STUDY THAT WILL COMPARE MORTALITY PATTERNS AND SPECIFIC CAUSES OF DEATH BETWEEN THOSE WHO SERVED IN VIETNAM AND THOSE WHO DID NOT; A TWIN STUDY THAT WILL EXAMINE PAIRS OF IDENTICAL TWINS (ONE OF WHOM SERVED IN VIETNAM AND THE OTHER OF WHOM DID NOT) TO DETERMINE WHETHER THE CURRENT PSYCHOLOGICAL AND PHYSICAL HEALTH OF VIETNAM VETERANS WAS ADVERSELY AFFECTED; A BIRTH DEFECTS STUDY WHICH IS BEING JOINTLY SPONSORED BY THE DEPARTMENT OF DEFENSE, THE DEPARTMENT OF HEALTH AND HUMAN SERVICES, AND THE VETERANS ADMINISTRATION TO DETERMINE WHETHER VIETNAM VETERANS ARE AT HIGHER RISK OF FATHERING CHILDREN WITH BIRTH DEFECTS THAN NON-VIETNAM VETERANS, AND FINALLY. A RETROSPECTIVE STUDY OF DIOXINS IN ADIPOSE TISSUE, IN COOPERATION WITH THE ENVIRONMENTAL PROTECTION AGENCY, TO DETERMINE THE BACKGROUND LEVELS OF DIOXIN IN FATTY TISSUE AMONG MALES OF THE VIETNAM-ERA VETERAN AGE GROUP, AND, WHETHER SERVICE IN VIETNAM HAS HAD AN EFFECT ON THE DIOXIN LEVELS, �4, MR, CHAIRMAN, WE RECOGNIZE ALSO THE NEED TO FULLY INFORM OUR VA STAFF IN THE FIELD OF THESE INITIATIVES AND TO KEEP THEM ADVISED OF THE MANY RESEARCH EFFORTS NOW UNDERWAY, ALSO, WE MUST ASSURE THE VIETNAM VETERAN THAT WE ARE DOING ALL WE CAN TO ADDRESS THE VERY SINCERE CONCERNS THEY RAISE ABOUT EXPOSURE TO AGENT ORANGE, TOWARD THAT END, WE WILL BE VISITING A NUMBER OF VA FACILITIES THROUGHOUT THE COUNTRY AND OFFERING A PROGRAM OF EDUCATION AND INFORMATION TO VA STAFF, VIETNAM VETERANS AND OTHER CONCERNED CITIZENS, WE WILL ATTEMPT TO BE FULLY RESPONSIVE TO QUESTIONS RAISED AND TO ENSURE THAT PROBLEMS THAT MAY BE EXPERIENCED BY VETERANS IN THEIR RELATIONSHIP WITH THE VA ARE PROMPTLY INVESTIGATED AND CORRECTED WHEREVER POSSIBLE, MR, CHAIRMAN, THIS CONCLUDES MY SUMMARY REMARKS, I AND MY COLLEAGUES WILL BE PLEASED TO ANSWER ANY QUESTIONS YOU OR OTHER MEMBERS OF THE COMMITTEE MAY HAVE, �GAO Beport GAO/HRD-83-6 Remedial Actions by Veterans Administration The Veterans Administration, in response to recommendations contained in the GAO Report, GAC/HRD-83-6 entitled "Inprovements Needed in VA's Efforts to Assist Veterans Concerned About Agent Orange" has taken the following remedial actions on those recommendations in which this Agency concurs: Recommendation; "Revise the exposure history form and use the standard VA physical examination and medical history forms to gather more thorough information during Agent Orange examinations." Action; EM&S Circular 10-83-38 entitled" Possible Exposure of Veterans to Herbicides During the Vietnam War, PCS 11-49" was issued to all VA health care facilities on March 1, 1983. This directive provided a revision to DM&S Circular 10-81-54, dated March 19, 1981, which was the subject of the GAO recommendation. This circular provides for some modification to Agent Orange Registry procedures and enactment a revised examination code sheet. It also specifies the use of standard history forms SF 504 and SF 505. Recommendation t "Require environmental physicians to review all examination records to ensure that examinations are thorough and documented." Action; DM&S Circular 10-81-12, issued January 14, 1981, responds to the recommendation to advise veterans of the results of their examination. This circular required physicians to document, via progress notes in the medical record, the findings of the examination. This was further stressed in the Chief Medical Director's Letter IL 10-81-5 issued February 11, 1981. Recommendation; "Direct VA medical facilities to ensure that examining physicians are familiar with available information on Agent Orange and that they provide this information to all veterans examined." Action i Nationwide conference calls with environmental physicians are ongoing and are being held six times annually. In addition to directives which are prepared on VA policy as it develops, significant informational materials are being forwarded on a periodic basis to environmental physicians. Environmental physicians are routinely responding to all veteran inquiries for information which may be raised during the initial examination process or during follow-up examinations. �Recommendation; "Direct VA medical facilities to inform veterans seeking Agent Orange examinations of the examination's limitations." Action; A Chief Medical Director's Letter, IL 10-82-37, entitled "VA Agent Orange Activities" was issued to VA field facilities on September 30, 1982. This letter advised environmental physicians of the need to make the limitations of the examination known to all registry participants. In addition, a nationwide conference call was made on August 13, 1982, stressing the importance of this procedure. Recommendation! "Emphasize to VA medical facilities the importance of sending tissue samples taken from veterans who served in Vietnam to the Armed Forces Institute of Pathology. Action; On September 30, 1982, a Chief Medical Director's Letter, IL 10-82-37, "VA Agent Orange Activities" was sent to all VA health care facilities. In addition to other topics, this letter emphasized the need for active support by those facilities in sending tissue specimens to the Armed Forces Institute of Pathology. This same message was related to all VA health care facilities during a nationwide conference call held on August 13, 1982. Recommendation; "Develop a monograph on Agent Orange's potential for causing birth defects." Action: A monograph on "Birth Defects/Genetic Screening" is tentatively scheduled to be published in June 1984. The scope and outline of the monograph is expected to be completed in May 1983 and the final selection of authors by June 1983. Recommendation t "Direct all VA medical facilities to offer to send the Agent Orange pamphlet to all telephone callers interested in information about Agent Orange, and advise callers when and where they can see the Agent Orange film." Action: This was accomplished through: ' Chief Medical Director's Letter, IL 10-82-37, entitled "VA Agent Orange Activities" released to VA health care facilities on September 30, 1982. * Nationwide conference calls with all VA health care facilities held on August 13 and September 27, 1982. Recommendation: "Use public service announcements to advise veterans of VA Agent Orange services." �Action: The Veterans Administration Office of Public and Consumer Affairs is now in the planning stage for the development of both audio and visual aids which will serve as public service announcements advising veterans of VA Agent Orange services. �Veterans Administration Department of Medicine and Surgery Circular 10-83-38 Washington, D.C. March 1, 1983 TO: 20420 Regional Directors; Directors, VA Medical Center Activities, Domiciliary, Outpatient Clinics, and Regional Offices with Outpatient Clinics (136) SUBJ: Possible Exposure of Veterans to Herbicides During the Vietnam War, PCS 11-49 1. This represents a revision of Circular 10-81-54, dated March 19, 1981. The following circular is referenced: 10-82-37 dated March 15, 1982. 2. The issue of Agent Orange continues to be a genuine concern to a large number of veterans, the scientific community and the chemical industry, and as a result, continues to receive extensive media attention. The VA remains in the forefront of this issue and continues to play a leading role in supporting scientific and educational initiatives in an effort to provide all concerned veterans with the information and guidance they need, as well as any medical care for which they are eligible. 3. The Agent Orange Projects Office (10A7) has the responsibility to coordinate and monitor all DM&S activities relating to the Agent Orange issue including the registry. All policy and clinical questions relating to the potential effects of herbicides should be referred to this office (FTS: 389-5412). Questions relating to eligibility of veterans or treatment of active duty personnel should be referred to Medical Administration Service (136) VACO (FTS: 389-2598/2849). 4. The maintenance of the Agent Orange Registry remains an important function of the VA and is managed centrally by the Agent Orange Projects Office (10A7). The Agent Orange Registry remains our most effective means of identifying concerned Vietnam veterans. The inportance of the role of each VA employee, beginning with the initial contact, in providing physical examinations and necessary treatment and advising the veteran of the results of the examination cannot be over-stressed. Any eligible Vietnam veteran expressing a concern relating to exposure to herbicides is encouraged to participate in the registry which includes a thorough medical examination. In addition, any eligible Vietnam veteran currently receiving treatment in VA medical centers and outpatient clinics will be identified and provided with the opportunity to participate in the Agent Orange Registry. Follow-up of the veterans entered into the registry will be conducted over a period of years in an effort to obtain further information regarding any long-term health effects resulting from these chemicals. THIS CIRCULAR EXPIRES ON FEBRUARY 29, 1984 �Circular 10-83- 38 March 1, 1983 5. VA Environmental Physicians play a roost significant role in determining the perceptions Vietnam veterans have concerning the quality of VA health care services and of their individual treatment by VA health care providers. The Environmental Physician will review the records of every Vietnam veteran examined to assure that a conplete physical examination was performed and documented. It is important that each veteran be fully advised of the limitations of an Agent Orange related examination, that is, what the examination can or cannot reveal as regards the presence of dioxin in the body system and/or the relationship to adverse health effects or potential health defects or illnesses which may or nay not be related to a veterans exposure to Agent Orange. I wish to strongly encourage your consideration of the best way to accomplish this conmunication process* The following alternatives might be considered. (1) Provide each Vietnam veteran reporting to the Outpatient Admissions area with a handout describing the purpose of the examination and its limitations. This can be further clarified by the examining physician during the course of the physical examination, preferably prior to beginning the physical examination process. (2) Provide each veteran with the opportunity to view the audiovisual "Agent Orange: A Search for Answers." Veterans and/or visitors to VA health care facilities should be informed concerning the film and when and where it can be viewed. (3) Make all Agent Orange pamphlets and other informational materials available to Vietnam veterans and the public - keeping them displayed in prominent areas and ensuring that sufficient copies are available for distribution. It should be standard operating procedure to provide copies of VA Agent Orange pamphlets to all telephone callers requesting Agent Orange information. 6. It is essential that a complete medical history and physical examination be performed and documented. The medical history should be documented on SF 50 4 and SF 505 and the physical examination should be documented on SF 506 or VAF 10-7978e. The Agent Orange Registry code sheet (VAF10-9009) does not replace any medical record. In eliciting the medical history and performing the physical examination (which should be conducted by/or under the direct supervision of the Environmental Physician), special attention will be given to those organ systems alleged to be most frequently �Circular 10-83-38 March 1, 1983 affected by exposure to herbicides containing TCDD. These include the liver, kidneys, skin and the reproductive, endocrine, immunologic and nervous systems. Particular attention will be paid to the detection of chloracne, a skin condition which has been associated with acute exposure to TCDD and other dioxins. Evidence will also be sought concerning the following potentially relevant symptoms or conditions: altered sex drive; sterility; congenital deformities among children; repeated infections; neoplasia; and for fenale veterans, difficulties in carrying pregnancies to term. In gathering these data, it is important to determine and record the time of onset of the symptoms or conditions; their intensity; the degree of physical incapacitation; and the details of any treatment received. The person actually performing the physical exam should be identified with the signature and title ( . . P.A., etc.). If the examiner is MD, other than a physician, a physician's countersignature is required, preferably the Environmental Physician. When an Agent Orange examination is done as part of a compensation and pension examination, the physical examination will be done by/or under the direct supervision of the Environmental Physician. 7. All veterans participating in the Agent Orange Registry will be given the following baseline laboratory studies: complete blood count, urinalysis, SMA-6, SMA-12, and a chest x-ray if one has not been done within the past 6 months. Appropriate additional diagnostic studies should be performed and consultations obtained as indicated by the patient's symptoms and physical and laboratory findings. Non-routine diagnostic studies, such as sperm counts, should be performed only if medically indicated. 8. The Environmental Physician will personally discuss with each veteran examined the results of the examination and the laboratory studies which are available at the time the physical examination is completed. This personal interview will be conducted in such a way as to encourage the veteran to discuss his/her own health concerns as well as those of his /her family as they relate to exposure to herbicides. In the absence of the Environmental Physician, the interview will be provided by a designated physician familiar with the Agent Orange program. The interviewing physician will document this action in a progress note in the veteran's medical record. In addition to the personal interview, a follow-up letter will be sent to each veteran explaining the results of the examination and laboratory studies. A copy of this letter will be filed in the veteran's administrative medical record. Recommended sample letters are provided in attachments A and B. 3-6, �Circular 10-83-38 March 1, 1983 9. Particular attention is directed to the Special Registry at the Armed Forces Institute of Pathology (see DM&S Circular, dated 10-82-37 March 15, 1982). All pathological material (autopsy, surgical, cytologic, or other similar tissue) obtained from any Vietnam veteran will be processed in accordance with DM&S Circular 10-82-37 for inclusion in this special registry. 10. It has been determined that the analytical technology for measuring minute levels (parts per trillion) of TCDD in human fat does exist. The results of this study, however, are inconclusive as regards exposure to herbicides in Vietnam. Therefore, no VA medical center will perform any surgical or other procedure for the purpose of obtaining tissue for measuring TCDD in patients without prior approval by VACO (10A7). 11. When a Vietnam veteran requests an Agent Orange examination at a VA medical center, the center's Medical Administration Service will be notified and will initiate the procedures listed below: a. Prepare a 3x5 card with the following typewritten information: (1) Veteran's full name (2) Veteran's address and telephone number (3) Date of birth (4) Social Security Number (5) Date of initial examination (6) Dates of follow-up examinations b. The card will be filed alphabetically in a special file, labeled "Agent Orange Registry.11 This registry card will be maintained until further notice. Every effort should be made to maintain the veteran's current address and telephone number. •c. Vh Form 10-10M contains a statement regarding "Possible Exposure." This item should be completed for ail veterans applying for the Agent Orange examination. 12. The original records of all examinations performed on Vietnam veterans for possible herbicide toxicity are to be retained in the veteran's Consolidated Health Record (CHR). If a CHR does not already exist for a veteran examined for herbicide toxicity, one will be established, and the results of the examination for herbicide toxicity is to be enclosed in the CHR. A locator card will be created with the establishment of CHR. 13. The following procedures pertain to active duty personnel according to the site of the Agent Orange examination: a. When active duty members of the uniformed services apply to TO facilities for an Agent Orange examination, the requirements of M-1, Part 1, Chapter 15 regarding the authorization from the 3-7 �Circular 10-83-38 March 1, 1983 appropriate branch of service and the billing of the appropriate branch of service will apply. The procedures of establishing a 3x5 card, of processing and completing the code sheet for active duty personnel will be the same as those followed for a veteran participating in the Agent Orange registry. b. However, a military facility may perform the Agent Orange examination according to VA instructions. Military facilities have been informed to obtain a copy of the pertinent VA directive and samples of appropriate forms from the nearest VA facility. The completed physical examination, laboratory tests, and questionnaire will be forwarded to the nearest VA medical center or outpatient clinic. For these individuals the Medical Administration Service personnel at the medical center will: (1) Prepare a colored 3x5 card with similar data as prepared for a veteran clearly label card as "Active Duty." Insert card in Agent Orange Registry file. (2) Abstract the data from the medical record documents to the code sheet. (3) Submit original code sheet to the VA Data Processing Center, Austin, TX as indicated in paragraph 18. (4) Forward copies of the medical record documents with a copy of the code sheet to VA Central Office (10A7A). (5) Place the original medical record documents in a plain folder properly identified with the name and social security number and a notation "Active Duty Agent Orange Exam at military facility." These folders should be maintained in a special location in the file room. (6) While the medical documents are not placed in the CHR (Type I or II folders), these special folders are subject to the same retention and disposition policies of the CHR. (7) If an active-duty military person becomes discharged and reports for treatment as a veteran, the Agent Orange examination will be filed in the CHR. 14. There is a high priority concern for prompt handling and scheduling Agent Orange examinations. Facilities should make every effort not to have 50 or more Agent Orange examinations pending at the end of the month. Facilities having 50 or more examinations pending will be contacted by Agent Orange Projects Office Staff to ascertain the plan of action to be implemented in reducing the backlog and to determine how many examinations are pending beyond 30 days. �Circular 10-83-38 March 1, 1983 15. A monthly submission of medical record documents and code sheets will be sent to VACO, Agent Orange Projects Office (1QA7A, Km B-67) according to the mailing schedule listed in paragraph 17. The monthly submission will contain the following: a. One legible copy of all the medical record documents relating to the Agent Orange examination. These documents should be placed in alphabetical order with the code sheets stapled on top of the medical record documentation for submission to 10A7A. Pertinent laboratory data and consultations obtained as part of these examinations will be held pending arrival of these data. Only copies of completed examinations should be submitt b. Follow-up examinations will be reported in the same manner. c. The Agent Orange Registry Code Sheet (VAF 10-9009} will be prepared in three copies. One copy will be filed in the veteran's CHR with the documentation from the Agent Orange examination. One copy will be stapled to the corresponding medical record documents that are sent to VAOO (10A7A). The original code sheet will be sent to the Austin Data Processing Center in (DPC). See paragraph 18 for instructions for mailing the code sheets to the DPC. 16. Instructions for completing the code sheets (VAF 10-9009) are listed in Attachment C. Effective with the issuance of this circular, the new code sheets (VAF 10-9009) must now be used. The Agent Orange Registry code sheet has been revised. DO NOT USE the VAF 10-9009 with November 1980 and September 1981 dates, tKey will no longer be accepted. The VAF 10-9009 with the 1982 date will be used. Old stocks of 1980 and 1981 VAF 10-9009 may be destroyed. The VAF 10-20681 (NR) Initial Data Base will no longer be used. 17. The following mailing schedule should be used for mailing the monthly submission to VAOO (10A7A) and the Austin DPC. Region Number Mailing Date 1 6th of Month 2 3 4 5 6 10th of Month 14th of Month 18th of Month 22nd of Month 26th of Month 3-; �Circular 10-83-38 March 1, 1983 18. The following instructions should be followed for the mailing of the original code sheet (VAF 10-9009) to the DPC. These code sheets will be nailed monthly. Code sheets must be received at the DPC according to the mailing schedule listed in paragraph 17. a. Batching of input documents; (1) Code sheets should be scanned to ensure all required fields have been completed. (2) Completed code sheets will be batched in groups of no more than 25 code sheets. Each batch will include code sheets for only one facility as indicated by identical entries in all six positions of the code sheet field one. Different facilities must be batched separately (i.e. VAMC one batch, OPC one batch). Batches of less than 25 code sheets are acceptable. (3) Attach a transmittal form to each batch of documents. Record the six position facility number and the number of documents on the transmittal. (4) Using the batch control log (see 18c below) assign the next sequential batch number and record it on the transmittal form. NOTE; Begin batching with batch number 001 in January of each year and continue with sequential numbers throughout the (5) Code sheets should be stapled together in the upper left-hand corner. No medical record documentation should be attached to these code sheets. (6) Corrected code sheets do not have to be batched separately or handled separately. They can be mailed with the regular code sheets as long as they are for the same facility number. b. Transmittal form: (1) Two copies of VA Form 30-7252, "Transmittal Form for the Use in Shipment of Tabulating Data," will accompany each batch of code sheets. One copy will be retained at 3-/C �Circular 10-83-38 March 1, 1983 C the Austin DPC and the other copy will be returned to the transmitting facility with the code sheets and edit analysis lists prepared at the DPC. (2) The transmitted form will be completed as follows: Item 2: Name and address of transmitting facility Item 3: Facility number of transmitting facility and correspondence symbol Item 6: Date of dispatch Item 7: Name and telephone number (ETS) of responsible individual at facility Item 8: Facility Number; The three (3) to six 16) position PTF facility number used on the code sheets of this batch (code sheet field #1) gatch number; The batch number assigned by the transmitting facility (see below —control log). Code Sheet Count; The number of code sheets in this batch {26 or less). (3) The following is an example of the completed transmittal form. [ TRANSMITTAL FORM FOR USE IN SHIPMENT OF TABULATING DATA ( ( VA Data Processing Center (200/392A) A 1615 East Woodward Street 1 Austin, TX. 78772 1 ATTN: Agent Orange Clerk I VA Medical Center A 50 Irving Street, N.W. 1 Washington, D.C. 20422 ) S. REPLJJ£^fS(«. no./tymbol) 4. EFFECTIVE DATE OF DATA L688/136B 1 5. NO. OF PACKAGES e. DISPATCH DATE 6A. FINAL MATCH fCA«*> 7. OFFICIAL RESPONSIBLE FOR SHIPMENT (N*mf. till* tall tlgnflun) Jane Smith 389-5412 8. TABULATING DATA REPORTS CONTROL SYMBOL (A) J O B N LJMBER |N| ( ii—MM" I 1(T 20A1 •»••»••»•• DESCRIPTION (C) AGENT ORANGE Facility number Batch number Code sheet count — —^ — NO. OF CORES CARD COUNT OF REPORTS (D) (E) 688 002 025 9. REMARKS VA FORM M/K vn.M 30-7252 EXISTING STOCK OF VA FORM 10-7252, MAR 1»66, WILL BE USED. - - O �CIRCULAR 10-83-38 March 1, 1983 (4) The encircled area on the copy of the transmittal sheet (the address of the DPC, address of the transmitting facility, station number, and mail symbol, job number, "Agent Orange," facility number, batch number, and code sheet count) should be overprinted on the VA Form 30-7252 at each facility. The facility number entered has to be the FTP or OPC number that is coded on the code sheet. c. Control log; As batches are prepared for submission to the DPC an entry should be made on the control log. Instructions for the use of the control log and an example of the control log follows; FACILITY (1) AGET7T ORANGE CONTROL LOG (2) (4) (3) (5) Batch 1 Code Date Date Number Sheets Sent Returnee 002 10-6-83 10-26-8J 25 (1) An Agent Orange address control log should be maintained for each facility (Facility Code Number). (2) The batch number will be assigned sequentially by facility. The batch number will be recorded on the log and on the transmittal sheet (Item 8). (3) The number of code sheets in the batch will be recorded on the log and on the transmittal sheet (Item 8). (4) Date the batch was mailed to the DPC. (5) Date the batch and associated edit output was returned from the DPC. �Circular 10-83-38 March 1, 1983 d. Mailing: (1) The facilities will establish their own control ever the mailing of code sheets to the DPC. In order to ensure that the computer files are current, each facility should submit input at least once each month. (2) The mailing address for the DPC is: VA DATA PROCESSING CENTER (200/392A) 1615 East Woodward Street Austin, TX 78772 ATTN: AGENT ORANGE CLERK (3) Contact the Agent Orange Clerk at the DPC regarding questions about submitting code sheets, batch control, etc., The telephone number is ETS 770-7281. It is not appropriate to call the DPC in regard to questions on code sheet completion or correction of rejections. These questions should be referred to Nancy Howard, VACO, PTS 389-5412. e. Processing: (1) The DPC will keypunch the data from the code sheets and the records twice each month (10th and 25th). Subsequent to editing, the DPC will return all batches and the edit lists to the transmitting facility, (2) While all code sheets will be returned to the transmitting facility, computer listings will reflect only rejected records. For correction of the rejected records, refer to the coding instructions in Attachment C. There will be no published edit list of how to correct errors; carefully following the instructions and double checking the information coded is absolutely essential1 Corrections are to be made on the returned code sheet with RED pen or RED felt-tipped pen or a new code sheet can be made with the corrections in the appropriate field(s). If a new code sheet is prepared for the return of a correction, do not just complete the corrected field(s)—all of the fields must be completed as if it were an initial input. DO NOT leave any blank fields. (3) All returned code sheets should be disposed of only after all information input is verified as correct. Refer to the RCS 10-1 schedule under Medical Administration Service section for the disposition schedule. 10 �Circular 10-83-38 March 1, 1983 (4) There has been a programming change in the editing process for the Agent Orange Registry. Several new error messages are appearing. Examples of the new messages and the corrective action needed are listed below: (a) ****** - means an error is in a field. ACTION - correct error and resubmit. (b) Duplicate Initial Exam - means there already appears on the file an initial Agent Orange examination for this veteran. It may be for the same reporting facility or a different VA facility. ACTION - No action is necessary. (c) Warning - No Initial Exam - means the file does not contain an Initial Exam record for this veteran, but the registry has accepted the follow-up record that was previously submitted. ACTION - Reconstruct the initial exam record and submit to the DPC. DO NOT resubmit the follow-up exam. 19. A monthly statistical report will be sent to VACO, Agent Orange Projects Office, Attn: Nancy L. Howard, PRA (10A7A, Rm, 848). Do not enclose this letter with the medical record documentation and code sheets sent to 10A7, Rm. B-67. This statistical report will be prepared on a monthly basis and should arrive in VACO (10A7) by the tenth workday following the end of the month. Negative reports are required. Please assure that accurate statistics are reported. For Satellite OPC's performing Agent Orange examinations do not submit the statistical report separately, The totals should~~Ee combined with the parent facility totals. Do not use the mailing schedule described in paragraph 17 for submission off this statistical report. This transmittal letter should contain: a. The number of initial examinations performed during the month; b. The cumulative total of initial examinations performed; c. The number of follow-up examinations performed during the month • d. The cumulative total of follow-up examinations performed; e. The number of initial examinations pending beyond the end of the month; f. The number of veterans failing to keep an initial examination appointment. 11 �Circular 10-83-38 March 1, 1983 See definiticns in Attachment D for an explanation of the monthly report terminology. A copy of the format for the statistical report is illustrated in Attachment E. It should be noted that the pending examination total (e) and the number of veterans failing to keep an initial examination appointment (f) are not cumulative totals. These apply to the report month only. 20. Special care should be addressed to the completion of the examination code sheets. A black ball-point pen or a black felt-tipped pen should be used. No pencils or blue ink pens should be used as these markings do not reproduce clearly. Carefully follow the instructions for completing the code sheets to assure that all data fields are completed. It is recommended that the Chief, Medical Information Section, be given the responsibility for the coding, completing, mailing of the code sheets to the DPC and the correcting of the code sheets to assure all areas are completed accurately. 21. This circular rescinds DM&S circulars: 10-80-203, dated September 12, 1980; 10-81-12, dated January 15, 1981; 10-81-54, dated March 19, 1981; 10-81-82, dated April 28, 1981; 10-81-115, dated June 4, 1981; 10-81-263, dated December 1, 1981; 10-82-5, dated January 18, 1982; and 10-82-110, dated June 28, 1982. W. jr^flCBY, JR., Deputy Chief Medical Director DISTRIBUTION: COB: (10) only plus (10A7) 500 SS (10A7) FLD: MA-5 each and RD, DO, OC & OCRO-2 each plus 200-8 EX: Box 44-6, Boxes 60, 54, 52-1 ea, & 63-5 12. 3- �ATTACHMENT A Circular 10-83-38 March 1, 198" (FACILITY LETTERHEAD) Positive Findings — Recommended Format Dear Veteran; We sincerely appreciate your recent participation in the Veterans Administration's Agent Orange Registry. This effort should prove to be very helpful in assisting us to better serve veterans, such as yourself, who are concerned about the possible adverse health effects of exposure to Agent Orange. A review of the results of your examination indicates that (Use this space to briefly describe any positive findings.) ___ In view of the above findings, we suggest that you contact the Outpatient Admissions Office at extension ____^^__ to schedule a follow-up examination. This will provide us with an opportunity to personally discuss these findings with you and to suggest or provide any essential medical treatment. Again, your participation in the registry is appreciated. Sincerely, (NAME) Environmental Physician A-l �MTACHWENT B Circular 10-83-38 March 1, 1983 (FACILITY LETTERHEAD; Negative Findings —- Recommended Format Dear Veteran: We sincerely appreciate your recent participation in the Veterans Administration's Agent Orange Registry. This effort should prove to be very helpful in assisting us to better serve you and your fellow veterans who are concerned about the possible adverse health effects of exposure to Agent Orange. The results of your examination and laboratory tests suggest that you are presently in good health and that you have no reason at this time to be concerned about possible adverse health effects resulting from exposure to Agent Orange. However, if in the future you have a medical condition about which you are concerned, I would encourage you to seek the help and advice of your nearest Veterans Administration Medical Center. The results of your examination will be maintained by the Veterans Administration and will be available for future use as needed. Again, your participation in the registry is appreciated. Sincerely, (NAME) Environmental Physician B-l 3-n �CIRCULAR 10-83-38 .March 1, 1983 Attachment C INSTRUCTIONS TOR ITEMS 1-20 for the Agent Orange Registry Codesheet. (VAF 10-9009). Item 1 - Facility Number - Suffix - Enter PTF facility code. Use the AMIS Suffix (BY, BZ etc) to indicate your satellite facility. DO NOT USE Q,R,S, Item 2 ~ Veteran's Name Beginning in block 8, enter veteran's last name (please print) using one letter per block.Apostrophes and hyphens in the name should not be used and empty blocks must not be left between the letters of the last name. Do not skip a space or use a comma if the last name is followed with JR, SR, I, II or III, etc. Beginning in block 34, print the first name, one letter per block. If there is a middle name, enter the middle name beginning in block 49 otherwise leave this block blank. Item 5 - Type of Exam - Enter A « initial? C « follow-up. To delete an entire initial examination with a noted error after it has been accepted into the registry, resubmit the original code sheet with a "B" coded in block 59 and submit a code sheet with the correct information with an "A coded in block 59. All fields must be conpleted on a resuhmission. The code sheets can be shipped in the same batch. An example for this usage will be for incorrect spelling of the name, incorrect social security number, changing of address etc. To delete an entire follow-up examination with a noted error after it has been accepted into the registry, resubmit the original code sheet with a "D" coded in block 59 and submit a code sheet with the correct information with a "C" coded in block 59. Item 6 - Social Security Number Block 60 should be left blank. Enter the SSN in blocks 61 through 69. If the veteran does not have a social security number, place the letter "P" in block 60 and assign a pseudo SSN. (See PTF instructions for pseudo SSN). Numerical zeros must be slashed ( ) 0. Item 7 -•Service Serial Number Enter the Service Serial Number beginning in block 70, unused blocks remain blank. Numerical zeros must be slashed ( ) 0. If the serial number begins with US, blocks 725-79 must contain a number(s). Fill unused block(s) with zero(s) for this instance only. If the serial nimber is unknown, enter a U i" block 70^ Unused blocks remain blank. C-l �Circular 10-83- 38 March 1, 1983 Example: 70 71 12 73 74 79 7e 77 1% 79 7 a 8 0 P J 7!4 74 75 76 77 78 7?) u 1 s 6 € i 0 IB 0 0 0 701 71 yJ! Service Serial Number 708000 Service Serial Number: US 66700000 70 71 72 73 74 75 76 77 78 79 U Veteran does not know serial number Item 8 - Date of Birth Enter the numerical equivalent for the month (blocks 80-81) and day (blocks 82-83). Enter the last two digits of the year of birth in blocks 84 and 85. Numerical zeros must be slashed ( ) 0. Example: MO. | DAY YR. "6H 81 82 83 84 85 0 5 0 9 4 7 May 9, 1947 Item 9 - Current Address Print the veteran's current address in the spaces provided. Use of one block per letter or number. Leave one blank space between street number and name. Print street address in blocks 8 - 1 . Print city or 611 town in blocks 112-137. Print zip code in blocks 138-142. Blocks 143-146 will be blank. Using the PTF codes, assign the proper country and state codes in block 147-151. Item 10 - Race/ Ethnicity Enter the appropriate code in block 152. Item 11-13 - Sexr Martial Status & Current Status of Veteran Enter appropriate codes. Item 14 - Branch of Service Enter appropriate codes in block 156. If veteran was in more than one branch of service (item 14), code the latest Vietnam service. 3-Jf �Circular 10-83-38 March 1, 1983 Item 15 - Biter the appropriate code for Vietnam service in block 157. If the veteran did not serve in Vietnam, blocks 158-173 should be left blank. Item ISA - Code the numerical equivalent of the month and code the last two digits of the year of last period of service in Vietnam. Numerical zeros must be slashed ( ) 0. Item 15B - If veteran had two or more periods of service in Vietnam, the next to last period of service should be coded in the blocks provided.If only one period of service in Vietnam code this in 17 (a) and leave 17(b) blank. Numerical zeros must be slashed ( ) 0. Item 16 - Corps or Area Served Enter the appropriate code (in block 174) for the corps or area in which veteran served. If he served in more than one, use code 6. Item 17 - Military Unit Enter the military unit in which the veteran served. Please specify complete unabbreviated title. (Company, battalion, corps, ship, division). Item 18 - Last Two Periods of Service Code the month and year of the last two periods of service in 18(a) and (b) regardless of whether or not they were in Vietnam. If veteran did not have more than one period of service, leave (b) blank. Item 19(a) - (e) Exposure to Agent Orange Place the most appropriate code that describes veterans exposure to Agent Orange in the block provided. Do not leave any block blank. Item 20 - Veteran's Health Enter the code that most appropriately describes veterans health. C-3 �Circular 10-83-38 March 1, 1983 INSTRUCTIONS FOR ITEMS 21-34 (THE ITEMS TO BE COMPLETED BY THE EXAMINING PHYSICIAN OR THE DESICCATED PHYSICIAN) Item 21 - Date of ..Exam Enter the numerical equivalent of the month, day, and year in the appropriate blocks. Item 2.2 - Veteran's Canplaint(s) Print the veteran's complaint(s) in the blanks provided. MAS personnel will fill in the blocks for 22(a), (b) and ( ) utilizing the ICD-9-CM c, ceding systems. Use the symptoms and signs categories (780-789) for this coding. The "78" has been preprinted for you. For uncodable symptoms, use 78999. For no known complaints use 7 0 0 80. Item 23 - Chief Complaint Enter appropriate code (1 or 2) in the block. Item 24 - Number of Complaints Enter the number of complaints the veteran has in the block provided. If the veteran has 5 or more complaints, enter 5 in the block. Item 25 - Evidence of Birth Defects in Veteran's Children? Enter the appropriate code for item 25. Item 26 - Diagnostic Work-up and/or Consultation If no work-up and no consultation has been done, enter code 1 in the blocks provided. If a work-up and/or consultation has been done, enter the appropriate code (2,3,4) in the blocks provided. All blocks must have one entry. Item 27 - Additional Workups/Consultations Specify any additional workups/consultations performed but not listed in item 26. Item 28 - Diagnosis Print the veteran's major medical diagnosis(es) in the spaces provided (a,b,c). For each diagnosis listed, MAS will utilize the ICD-9-CM coding system. Any diagnosis relating to a neoplasm should be documented in item 29. 04 �Circular 10-83-38 March 1, 1983 Item 29 -Evidence of Neoplasia Block 240 of ths section must be completed with the appropriate response. If the veteran has a neoplasm or has a known history of a neoplasm, document the appropriate diagnosis and the specific ICD-9-CM diagnostic code must be listed in blocks 241 to 245. If no neoplasm is recorded/ leave blank. Item 30 - No Disease Pound If no disease is found, put a 1 in block 246. Otherwise, leave this block blank. Item 31 - Years of Onset For each listed diagnosis in item 28, code the last two digits of the year of onset; leave blank if year of onset is unknown. Item 32 - Disposition Place a code (1 or 2) in each block provided. Do not leave any of the blocks blank. For section d in item 32, if the veteran was referred for VA outpatient care, indicate the two digit code for the clinic in the designated blocks (257-266). Refer to the Outpatient Routing List (VAF 10-2875-1) for the clinic codes to be utilized to code this section. Item 33 - Remarks Utilize this space for additional information. Item 34-36 - Name and Title of Examiner The name and title of the examiner should be printed in the space provided. The examiner should also sign his/her name. Information to be abstracted for a follow-up examination: Items 1 through 13 - must be completed Items 14 through 20 - no entry Item 21 - must be completed Items 22 through 33 - may be blank unless you have follow-up data to report in in any of these items. Items 34 through 36 - must be completed PLEASE NOTE: The first time a follow-up visit is recorded on the revised code sheetTor a veteran who previously received an initial exam recorded on the old code sheet, every attempt should be made to obtain and record the information to complete Items 14-20. C-5 �Attachment D ttrcular^-83- 38 DEFINITIONS FOR TOE MONTHLY PEPORT TERMINOLOGY 1. Initial Examination t First time Agent Orange examination given for the purpose of entering a Vietnam veteran into the Agent Orange Registry. The total of initial examinations given during the period of the current report (i.e., 30 initial exams given during January). 2. Cumulative Initial Examination; Includes the total number of "first-time" examinations performed by the medical facility since the beginning of the registry in 1978. Examinations performed by satellite outpatient clinics should be included in the total cumulative figure for the V& medical center of jurisdiction. Independent outpatient clinics should report in a manner similar to the VA medical centers. 3. Follow-up Examination; Any Agent Orange-related examination/visit subsequent to the initial examination. 4. Cumulative Follow-up Examination; Includes the total number of follow-up examinations performed by the medical facility since the beginning of the registry in 1978. 5. Pending Examinations; Initial Agent Orange examinations for which appointments have been scheduled beyond the end of the month. 6. Number of veterans failing to keep an initial examination appointment; number of veterans who failed to Keep a scheduled appointment during, the month. D-l �ATTACHMENT E Circular 10-83-38 March 1, 1983 EXAMPLE (FACILITY LETTERHEAD) Agent Orange Projects Office (10A7) ATTN: Nancy L. Howard, ERA \fc Central Office, Bm. 848 810 Vermont Avenue, N.W. Washington, D C 20420 .. SUBJECT: Monthly Report on Possible Exposure of Veterans to Herbicides During the Vietnam War, RCS 11-49 1. Hie following information is submitted for the month ending t facility number . a. Total number of initial examinations performed _____ b. Cumulative total of initial examinations performed _ c. Total number of follow-up examinations performed d. Cumulative total of follow-up examinations performed e. Number of pending initial examinations at the end of the month f. Number of veterans failing to keep an initial examination appointment 2. Garments/problems regarding pending exams: 3. The name and FTS number of the person preparing the report: (Name) MEDICAL CENTER DIRECTOR •MMt E-l �Department of Medicine •nd Surgery Veterans Administration Washington* 0*c> * ^ iL-io-81-5 February 11, 1981 CHIEF MEDICAL DIRECTOR'S LETTER TO: . Directors, VA Medical Centers, Medical and Regional Office Centers, Domiciliary, Outpatient Clinics and Regional Offices with Outpatient Clinics SCJBJ: Follow-Up Activities Related to Agent Orange 1. Last October, at the request of the Administrator, I asked the Office of Environmental Medicine to initiate a sample survey of veterans' satisfaction with the Agent Orange examination process. By the end of November we had received answers from approximately 55% of the 643 veterans to whom the questionnaire was distributed. For the most part these were randomly selected veterans who had been examined in seven VAMC's. 2. An analysis of the survey suggests that in the majority of cases a VA physician did-not discuss the results of the physical examination with the veteran, and that in about 80% of cases the veteran did not receive the results of his/her laboratory teats. Even if this is not a totally representative sample, the survey does suggest that we need to make some improvements in our Agent Orange examination procedures. 3. DM&S Circular 10-81-12 which was distributed by teletype on January 15, 1981, provided guidance which when implemented should accomplish some of these needed improvements. I am attaching two recommended sample letters referred to in paragraph l.B. of the circular. These letters are meant to serve only as a guide. It is likely that in some cases a modification of the sample letter should be made. It is urged that the appropriate follow-up letter be sent to all veterans who have been examined since January 1, 1981. It is recommended that the letter be signed by the environmental physician as the staff member charged with the responsibility of coordinating the Agent Orange Program in your facility. 4. Questions concerning follow-up procedures should be directed to Dr. Barclay M. Shepard, Special Assistant for Environmental Medicine, or to staff members Layne Drash or Nancy Zanis (FTS 389-5412/13). DONALD L. CUSTIS, M.D. Chief Medical Director Attachments In ftapty Mtr To: Distribution: COB: (10) only plus (102) 30 SS (101B1) FSB: EX: MA, DO, OC, OCRO Boxes 60 and 44-1 ea. 2 *N «**? """ol �ATTACHMENT A February1!!, 1981 (STATION LETTRRHEAD) Positive Findings — Recommended Format Dear Veteran: We sincerely appreciate your recent participation in the Veterans Administration's Aqent Oranqe Reoistry. This effort should prove to be verv helpful in assisting us to better serve veterans, such as yourself, who are concerned about the possible adverse health effects of exposure to Aqent Oranqe. A review of the results of your examination indicates that (Use this space to briefly describe anv positive findings.) In view of the above findings, we suggest that you contact the to Outpatient Admissions Office at extension schedule a follow-up examination. This will provide us with an opportunity to personally discuss these findings with you and to suggest or provide any essential medical treatment. Again, your participation in the reqistry is appreciated. Sincerely, (NAFF) Chief of Staff A-l �ATTACHMENT B IL 10-81-5 February 11, 1981 (STATION LETTERHEAD) Negative Findings —- Recommended Format Pear Veteran: We sincerely appreciate your recent participation in the Veterans Administration's Agent Orange Registry. This effort should prove to be very helpful in assisting us to better serve you and your fellow veterans who are concerned about the possible adverse health effects of exposure to Agent Orange. The results of your examination and laboratory tests suggest that you are presently in good health and that you have no reason at this time to be concernect about possible adverse health effects resulting from exposure to Agent Orange. However, if in the future you have a medical condition about which you are concerned, I would encourage you to seek the help and advice of your nearest Veterans Administration Medical Center. The results of your examination will be maintained by the Veterans Administration and will be available for future use as needed. Again, your participation in the registry is appreciated. Sincerely, (NAMF) Chief of staff B-l 3-27 �Department of Medicine end Surgery Washington D.C. 20420 Veterans Administration IL-10-82-37 September 30, 1982 In Reply Refer To: 102 CHIEF MEDICAL DIRECTOR'S LETTER TO: Directors, All DM&S Field Activities SUBJ: VA Agent Orange Activities *• General; The issues raised by the defoliant Agent Orange continue as a major concern to some Vietnam veterans, the general public and the media. Until some answers surface as a result of intensive Agent Orange related research being undertaken by the Veterans Administration (VA), other Federal agencies and public or private institutions, it can be anticipated that we will need to intensify our efforts to address the specific concerns of these individuals in a compassionate and forthright manner. This letter will serve to advise you of positive actions which can be undertaken at your facilities, actions which will contribute to the effectiveness of our delivery of health care services and assist in improving the perceptions Vietnam veterans may have concerning the VA's traditional role as the veterans' advocate. 2 * Agent Orange Registry: a. The Agent Orange Registry remains our most effective means of identifying concerned Vietnam veterans. The importance of the role of each VA employee, beginning with the initial contact, in providing physical examinations and necessary treatment and finally, advising each veteran of the results of the examination cannot be over-stressed. In this regard, VA environmental physicians play a most significant role in determining the perceptions Vietnam veterans have concerning the quality of VA health care services and of their individual treatment by VA health care providers. DM&S Circular 10-81-12 issued January 15, 1981, directed environmental physicians to advise veterans of the results of their examinations. This was further stressed in a Chief Medical Director's Information Letter, IL-10-81-5 dated February 11, 1981. Implicit in the circular and information letter is the importance of a careful review of each examination record prior to advising the veteran of the �11 10-82-37 September 30, 1982 results of the examination and laboratory studies. This review is also essential to ensure that the details and results of each examination are adequately documented in the veteran's medical record. b. It is important that each veteran be fully advised of the limitations of an Agent Orange related examination, that is, what the examination can or cannot reveal as regards the presence of dioxin in the body system and/or the relationship to adverse health effects or potential health defects or illnesses which may or may not be related to a veterans exposure to Agent Orange. I wish to strongly encourage your consideration of the best way to accomplish this communication process. The following alternatives might be considered: (1) Provide each Vietnam veteran reporting to the Outpatient Admissions area with a handout describing the purpose of the examination and its limitations. This can be further clarified by the examining physician during the course of the physical examination, preferably prior to beginning the physical examination process. (2) Provide each veteran with the opportunity to view the audiovisual "Agent Orange: A Search for Answers." Veterans and/or visitors to VA health care facilities can be informed concerning the film and when and where it can be viewed. (3) Make all Agent Orange pamphlets and other informational materials available to Vietnam veterans and the public - keeping them displayed in prominent areas and ensuring that sufficient copies are available for distribution. It should be standard operating procedure to provide copies of VA Agent Orange pamphlets to all telephone callers requesting Agent orange information. 3. Pathological Tissue Specimens (AFIP). The need to send tissue samples to the Armed Forces Institute of Pathalogy (AFIP) has been stressed in a series of circulars (DM&S Circulars 10-78-234, 10-79-239, 10-80-229, 10-82-37) and during several nationwide conference calls between Environmental Medicine Office and your facilities. �IL 10-82-37 September 30, 1982 Although the response to these directives has been most positive in some quarters, it appears that there is a need for each VA health care facility to further review these directives to ensure maximum conformance with the goal of sending pathological materials obtained from all Vietnam veterans to the AFIP. I am confident that you will respond quickly to the necessity of doing so whenever possible. 4. Birth Defects. Vietnam veterans continue to express their concerns and in some instances, fears regarding the possible adverse health effects of exposure to Agent Orange or other environmental substances used in Vietnam. The Veterans Administration does not have legislative authority to provide birth defects counseling, care or treatment to the spouses of Vietnam veterans, for Agent Orange concerns. Nevertheless, in spite of the fact that we have no scientific evidence to relate to veterans concerning possible adverse effects we should take every opportunity to assist them whenever a veteran expresses a concern in this regard. I view this assistance as possible through a referral of these individuals to accredited birth defects/genetic counseling resources within the community. It was for this reason that on September 18, 1981, a copy of the March of Dimes Birth Defects Foundation publication entitled "Birth Defects - Genetic Services" was provided to each environmental physician. This can serve as a directory of genetic counseling services to which Vietnam veterans can be referred. This alternative method of assistance can be of great benefit in relieving many of the anxieties being expressed by Vietnam veterans reporting for an Agent Orange related examination at our facilities. We should view their inquiries as an opportunity to provide them with any available information, including VA Agent Orange pamphlets, which briefly address the issue of Agent Orange and possible birth defects as a result of exposure to this defoliant. 5. In conclusion, I wish to reaffirm my personal commitment to resolving the complex scientific and medical issues as well as many social concerns raised by Agent Orange. This commitment includes the need to assist Vietnam veterans whenever and wherever possible until these issues are resolved and we can effectively ascertain what further steps, if any, need to be taken. I repose great confidence in the support provided by all VA staff to ensure that our Vietnam veterans are given quality health care assistance and are treated with the dignity and respect to which they are entitled. [ L) lUi yj^jULc/.'v . DISTRIBUTION: COB: (10) only plus SS (102) (101B1) 30 & (102) DONALD L. CUSTIS, M.D. _ _ . ^§2. Chief Medical Director «* B^to^nd 44-1 ea. 634ZB1 3-30 �3, 98ra CONGRESS IST SESSION H. R. 1961 To amend title 38, United States Code, to provide a presumption of service connection for the occurrence of certain diseases related to exposure to herbicides or other environmental hazards or conditions in veterans who served in Southeast Asia during the Vietnam era. IN THE HOUSE OF REPRESENTATIVES MAECH 8, 1983 Mr. DASCHLE (for himself, Mr. PANBTTA, Mr. BONIOB of Michigan, Mr. EDGAR, Mr. LONG of Maryland, Mr. WILLIAMS of Ohio, Mr. RICHABDSON, Mr. APPLEGATE, Mr. GARCIA, Mr. KASTENMEIEB, Mr. OLIN, Mr. SMITH of New Jersey, Mr. MOAKLEY, Mr. OTTINGEB, Mr. WHITEHUBST, Mr. BABNES, Mr. KASICH, Mr. LELAND, Mr. FEIGHAN, Mr. EATCHFOBD, Mr. DUNCAN, Mr. FOBD of Michigan, Mr. SMITH of Florida, Mr. FBANK, Mr. TALLON, Mr. YOUNG of Alaska, Mr. MUBTHA, Mr. STABK, Mr. MOBBISON of Connecticut, Mr. OWENS, Mr. SIMON, Mr. ROE, Mr. FAUNTBOY, Mr. MITCHELL, Mr. SCHEUEB, Mr. STUDDS, Mr. DOBGAN, Mr. LAFALCE, Mr. EBDBEICH, Mr. COBBADA, Mr. ECKABT, Mr. FOBD of Tennessee, Mr. TBAXLEB, Mr. SPBATT, Mr. WILLIAMS of Montana, Mr. OBEBSTAB, Ms. MIKULSKI, Mr. PEBKINS, Mr. LOWBY of Washington, Mr. McKiNNEY, Mr. HEBTEL of Michigan, Mr. WIBTH, Mrs. SCHNEIDEB, Mr. LANTOS, Mr. MABTINEZ, Mr. BEBMAN, Mr. SHANNON, Mr. KILDEE, Mr. D'AMOUBS, Mrs. COLLINS, Mr. FOGLIETTA, Mr. LEVINE of California, Mr. WEISS, Mr. HABBISON, Mr. FAZIO, Mr. MINETA, Mr. STOKES, Mr. DWYEB of New Jersey, Mr. MUBPHY, Mr. WEAVES, Mr. McHuon, Mr, HOWABD, Mr. DUBBIN, Mr. MABKEY, Mr. BATES, Mr. SEIBEBLING, Mr. VENTO, Mr. BOBSKI, Mr. DONNELLY, Mr. SUNIA, Mr. MBAZEK, Mr. ADDABBO, Mr. RODINO, Mrs. KENNELLY, Mr, BEBEUTEB, Mr. DELLUMS, Mrs. BOXES, Mr. EDWABDS of California, Mr. JEPFOBDS, Mr. BBOWN of California, Mr. SHABP, Mr. PENNY, Mr. FISH, Mr. ASPIN, Mr. KEMP, Mr. FLOBIO, Ms. OAKAB, Mr. GOBE, Mr. HABKJN, Mr. OXLEY, Mr. DE LUGO, Mr. McCLOSKEY, Mr. GUNDEBSON, Mr. GlLMAN, Mr. KOGOVSEK, Mr. TOBBICELLI, Mr. HOBTON, Mr. DIXON, Mr. EVANS of Illinois, Mr. MILLEB of California, Mr. WOLPE, Mr. GLICKMAN, and Mr. SLATTEBY) introduced the following bill; which was referred to the Committee on Veterans' Affairs �A BILL To amend title 38, United States Code, to provide a presumption of service connection for the occurrence of certain diseases related to exposure to herbicides or other environmental hazards or conditions in veterans who served in Southeast Asia during the Vietnam era. 1 Be it enacted by the Senate and House of Representa- 2 lives of the United States of America in Congress assembled, 3 That this Act may be cited as the "Vietnam Veterans Agent 4 Orange Belief Act". 5 SEC. 2. The Congress finds that— 6 (1) certain adverse health effects occurring among 7 persons who served in the Armed Forces in Southeast 8 Asia during the Vietnam era, and certain birth defects 9 occurring among the children of such persons, may be 10 the result of the exposure of such persons during such 11 service to phenoxy herbicides (including the herbicide 12 known as Agent Orange) and the class of chemicals 13 known as the dioxins produced during the manufacture 14 of such herbicides or to other factors involved in such 15 service including exposure to other herbicides, chemi- 16 cals, medications, or environmental hazards or condi- 17 tions; and 18 (2) a comprehensive review and scientific analysis 19 of the literature covering studies relating to whether 20 there may be long-term adverse health effects in HR 1961 IH SL -S. �3 1 humans from exposure to any of the class of chemicals 2 known as the dioxins produced during the manufacture 3 of the various phenoxy herbicides (including the herbi- 4 cide known as Agent Orange), as required by section 5 307(a)(l)(B) of Public Law 96-151, has been complet- 6 ed and submitted to the Veterans' Administration. 7 SBC. 3. Section 312 of title 38, United States Code, is tr 8 amended by adding at the end the following new subsection: 9 "(d)(l) For the purposes of section 310 of this title and 10 subject to the provisions of section 313 of this title, in the 11 case of a veteran who served in Southeast Asia during the 12 Vietnam era and who after such service suffers from a dis13 ease described in paragraph (2)(A) of this subsection, such 14 disease shall be considered to have been incurred in or aggra15 vated by such service, notwithstanding that there is no record 16 of evidence of such disease during the period of service. 17 "(2)(A) The diseases referred to in paragraph (1) of this 18 subsection are the following: 19 "(i) Soft-tissue sarcomas. 20 "(ii) Porphyria cutanea tarda. 21 "(iii) Active and residual chloracne and chloracne- 22 form lesions. 23 "(iv) A disease listed in a regulation prescribed by 24 the Administrator under subparagraph (B) .of this para- 25 graph. HR 1961 IH �4 1 "(B) The Administrator may determine, and prescribe 2 by regulation, diseases (in addition to those listed in subpara3 graph (A) of this paragraph) that medical research has shown 4 may be due to exposure to herbicides, chemicals, medica5 tions, or environmental hazards or conditions. The Adminis6 trator shall include in such regulations a specification of the 7 standards used by the Administrator in making such determi8 nation. 9 "(3) Paragraph (1) of this subsection shall terminate on 10 the first day of the first month beginning after the end of the 11 one-year period beginning on the date the Administrator sub12 mits to the appropriate committees of Congress the first 13 report required by section 307(b)(2) of the Veterans Health 14 Programs Extension and Improvement Act of 1979 (Public 15 Law 96-151; 93 Stat. 1098).". O HR 1961 IH �VIETNAM ETERANS IN CONGRESS Tom Daschle, South Dakota 439 Cannon Building, Washington. D.C. 20515 Vice Chairman: Leon Panetta, California 431 Cannon Building. Washington, D.C. 20515 1/31/83 FEB STEERING Dear Colleague: COMMITTEE: Don Bailey The deadly contaminant, d i o x i n , present in certain Pennsylvania h e r b i c i d e s used in V i e t n a m , i n c l u d i n g Agent Orange, has been David Bonlor called the roost toxic synthetic chemical known to man. You Michigan may be aware that d i o x i n was the chemical recently d i s c o v e r e d Hal Daub in Times Beach, Missouri, Nebraska Allen Ertcl Pennsylvania James Florio New Jersey H, John Heinz Pennsylvania John LaFalce New York Denny Smith Oregon Public Lav 96-151 m a n d a t e d the Veterans Administration to conduct a vorld-vide literature reviev of research conducted on phenoxy herbicides and dioxin. This reviev has documented a number of adverse health effects resulting from exposure to dioxin and related compounds. These include soft-tissue, lymphatic and stomach cancer, liver abnormalities, nerve damage, neuroasthenia (fatigue, i n s o m n i a , etc.) and others. Yet, the VA for years has dismissed veterans' claims that their adverse health effects result from exposure to dioxin and other chemicals in Vietnam. We believe it is time to begin compensating Vietnam veterans vho suffer from these illnesses. We feel the best vay to do so is to establish a series of presumptions that certain i l l n e s s e s and conditions are related to Vietnam service and are therefore compenseable. As a result, ve will be introducing legislation that will allow the VA to compensate Vietnam veterans for diseases and illnesses which the literature has linked to herbicide exposure. In the 97th Congress, similar legislation enjoyed widespread bi-partisan support. This legislation is not precedent setting as the VA already lists over hO d i s e a s e s it presumes to be service related. Despite possessing more e v i d e n c e and knowledge of dioxin's effects on humans than many of the other hO presumptions, the agency continues to deny c l a i m s . It is time for Congr.ess to act and we invite you to Join with us as an o r i g i n a l cosponsor of this legislation. Please call Ryan at 5-2803 or Scott, at 5-2861 to cosponsor or for a d d i t i o n a l i n f o r m a t i o n . CE 1 V nett a 3 1983 Office of the Assist to the CMD -°~& �E1680 April 19, mS CONGRESSIONAL RECORD — Extensions cf Remarks i tneur last days concepts of health care delivery in the Gordon Bricken has taken part In nally 111 children various programs that have had a at home. medical field. Franklin General's second decade beneficial impact on the city of Santa to commend three I would also tinder community sponsorship was a Ana. Mayor Bricken led the Orange other volunteer >ups that will be dynamic period. During that time, the County delegation to the "Invest in honored by tin Westchester County hospital had completed a new 16-bed America's Cities" Conference in Hong Volunteer ,u. The Westchester emergency department, an urgently Kong and served on the board of direc- Nature Hel; are a group of volun1 needed 99-bed addition, and a 300-car tors of the Santa Ana Economic Devel- teers who pro :de, at any time of day parking field. Included in the addi- opment Corp. ' or night, emo] ional support for their tions to the facility were an eight-bed In addition, as chairman of the neighbors. Al iough informally orgacoronary care unit and an eight-bed urban rail subcommittee of the UjS. nized, this >up has provided crucial intensive care unit, which is consid- Conference of Mayors, Mr. Bricken preventive tal health intervention. ered one of the finest in the area. Also has supported local rail transportation Roger C. bUlmeno will be receiving included was a 21-bed short-term psy- through active participation in local the student •olunteer award. His work, chiatric unit. and national conferences. extended far beyond his though, The hospital is looking forward to a In recognition of his distinguished student pi Iject. Mr. Paulmeno volun• third decade of service to its surround- and unselfish contribution toward teers at ie Geriatric Continuing ing communities. Franklin General civic betterment, it is with pleasure Treatmen Program of Central Westnow has a total of 305 beds, including that I invite my colleagues to join me Chester tal Health is a new set of initiatives geared toward in recognizing Gordon Bricken for his extensive: involved in Service. He of all aspects teaching programs, home care and dedicated work as mayor. of Santa patient and has long-term care services and other out- Ana, Calif. The citizens of Santa Ana gralpart if the staff. become an intereach programs geared for the elderly. and I appreciate the .mayor's hard Finall; I would like to As a member of the hospital's advi- work and accomplishments and will the workers at Reader'scongratulate Digest for sory committee, I believe the future miss his outstanding leadership.* their involvement in Project LIVE. holds many promises for-Franklin This program, provides a one-to-one General. Despite changes and innovatutoring experience for middle school tions in the hospital field, one thing SHEILA PETERSEN: VOLUNTEER children who have fallen behind the OF THE YEAR remains constant: Franklin Genera} is required reading level. The employees continuing its commitment to provid- > at Reader's Digest who have voluning quality health care to all.* HON. R1CHARDL OHINGER teered their time, tutor the children at OF HEW YORK work, tihus providing them both with IM THE HOUSE OF REPRESENTATIVES ALL-AMERICAN CITY AWARDED help inj basic skills, yet also added voTO SANTA ANA , . Tuesday, April 19,1983 cational exposure. This program has • Mr. OTTINGER. Mr. Speaker, I been most instrumental in increasing HON. JERRY M. PATTERSON would like to extend my congratula- the1 children's academic and emotional Or CALIFORNIA tions to Sheila Petersen, of North gro IN THE HOUSE OP REPRESENTATIVES Salem, N.Y., who is being named WestChester County Volunteer of the Year, Tuesday, April 19,1983 CHEMICAL CO., AND 9 Mr. PATTERSON. Mr. Speaker, the 1983, by the Volunteer Service Bureau ' DIOXIN city of Santa Ana was recently chosen of Westchester County. Her dedication to Improving the as a recipient of the All-American City . HON. THOMAS A. DASCHLE Award, a national .honor bestowed by quality of life for terminally ill chil OP SOUTH DAKOTA the National Municipal League. Be- dren has made her truly deserving of IN THE HOUSE OF REPRESENTATIVES cause the award recognizes citizen in- this award and I would like to share volvement by community residents, it some of her achievements with my col Tuesday, April 19,1983 is also a direct reflection on the mayor leagues. In 1978 Ms. Petersen pioneer ed the fund "Friends of Karen"-to • Mr. DASCHLE. Mr. Speaker, in of Santa Ana, ^Gordon Bricken. Having served as mayor of Santa raise money for Karen Maclnnes, a today's New York Times, April 19, Ana since April 14, 1981, Mr. Bricken terminally ill patient who wished to 1983, a front page article appeared redie at home. Ms. Petersen's fund rais- vealing what many of us have been is now stepping down from that post. Gordon Bricken has been an out- ing drive made this possible. The saying for some time; that the Dow standing leader in contributing to the money was used so that Karen could Chemical Co^was aware of the health general welfare and prosperity of the receive proper medical care yet remain hazards and toxicity of dioxin, the city of Santa Ana, and has been a cen- at home surrounded by those thai contaminant. found in agent orange and other herbicides, before extensive tral force in the growth of the commu- loved her. nity. Mr.. Bricken has been instrumenThis was just the beginning of Ms use of agent orange and these other tal in creating a new image for the city Petersen's work with terminally ill herbicides occurred both in Southeast of Santa Ana through community ac- children. Because of her complete Asia and in the United States. Dow of tivities such as the Golden City Days, dedication the "Friends of Karen' course, made no effort to notify the the Community Christmas Tree and fund continues to thrive, increasing USDA, DOD, or any other major govChristmas Parade, and the Ambassa- public awareness of terminally ill chil ernmental purchaser of dioxin condor's Ball. He has also encouraged dren's desire to be able to die at home taminated herbicides of their con, open communications between citizens while raising the funds to make thfe cerns. , and local government through commu- possible. Dow's track record oh dioxin has nity programs such as the Mayor's Ms. Petersen's work does not stop been far from exemplary and the inRoundtables and the Santa Ana To- with this fund. She provides much formation revealed in the Times artimore than financial assistance to f ami cle today further damages the claims morrow Conferences. . During Mr. Bricken's term as mayor, lies with terminally ill children. In of Dow, the Veterans' Administration many projects came to fruition in the stead she gives all of her resources anc and others that dioxin is relatively city of Santa Ana, Including the makes herself available at all times tc safe and that veterans in Vietnam are awarding of a cable television fran- bring emotional support to these f ami unlikely to be suffering unusual chise, the opening of the Downtown lies during a most difficult time, health effects as a result of their exParking Structure, the initial develop- must truly commend Sheila Petersen posure to dioxin contaminated chemiment of Sasser Park, and the opening once again, and wish her continued cals. I submit this article for the of the Orange County World Trade success as she makes it possible both RECORD and hope that all Members Center, financially and emotionally for termi and staff will take the time to read it. �April 19,1983 CONGRESSIONAL RECORD — Extension* of Remarks E1681 human experiments are generally prohibitUmTATION TO MEETING The article follows: The pretrial motion filed by Yannacone St ed by medical ethics. Animal tests, which IFrom the New York Times, Apr. 19,1083] Associates quoted a number of documents. are universally accepted by scientists as pro1965 MBMOS SHOW Dow's ANXIETY ON V. K. Rowe, then director of Dow's Bio- viding essential guidance on appropriate exDIOXIN chemical Research Laboratory, said in his posure levels for humans, are not a perfect (By David Burnham) Invitation to the meeting that Dow had guide because various species react differWASHINGTON, April 18—Almost 20 years been researching "toxicological problems ently. In laboratory rats, concentrations as small ago, scientists from four rival chemical com- caused by the presence of certain highly panies attended a doled meeting at the toxic impurities in certain samples" of the as five parts per 1,000 million have caused Dow Chemical Company's headquarters. herbicide 2,4,5-T and wished to share its statistically significant increases of cancer The subject was the health hazards of findings. The Dow laboratory was and is rec- In rats. dioxon, a toxic contaminant found in a ognized as one of the world's finest privateTwo studies, conducted on a group of forwidely used herbicide that the companies ly owned toxicology labs. estry workers in northern Sweden and on a manufactured. Two days after the meeting, C. L. Dunn, a group of agriculture workers In southern Shortly after the meeting in Midland, chemist who was manager for regulatory af- Sweden, point to a possible association beMich., on March 24, 1965, one of those at- fairs for Hercules, summarized in writing tween exposure to herbicides contaminated tending wrote In a memorandum that Dow what he had been told. with dioxin and an increased risk of softdid not want its findings about dioxin made "Dow says that their examination of their tissue cancers. Other studies, however, inpublic because the situation might "ex- own and competitors' 2,4,5-T products con- cluding one In New Zealand, show no higher plode" and generate a new wave of govern- tain what they call 'surprisingly high' risk of cancers for a group of farmers,.forment regulation for the chemical industry. amounts of the toxic impurities," be wrote. esters and fisherman exposed to dioxin than Another scientist noted that Dow officials "In addition to the skin effect," he wrote, in men in other occupations. had disclosed at the meeting a study which describing the results of tests on rabbits, WARNING OK DIOXIN STUDIES showed that dioxin caused "severe" liver "liver damage is severe, and a no-effect level Dr. Samuel 6. Epstein, a physician who is damage in rabbits. based on liver response has not yet been esDioxin, which has also been linked to tablished. Even vigorous washing of the skin professor of occupational and environmenbirth defects and skin disorders in labora- 15 minutes after application will not pre- tal medicine at the University of Illinois tory animals, is believed to be the deadliest vent damage and may possibly enhance the Medical Center in Chicago, cites the Swedchemical made by man, but Its effects on absorption of the material. There is some ish studies and other research on such questions as reproductive abnormalities to chalhumans have been difficult to prove conclu- evidence it is systemic." lenge the statement of Dow's president that sively. Since the Midland session, various run OH SITUATION there is no evidence that dioxin causes any studies have yielded conflicting evidence on Dr. John Frawley, the chief toxicologlst whether dioxin Increases the risk Of cancer for' Hercules, who had also attended the more damage than a skin rash. "For Mr. Oreff ice to make that statement is absurd," in humans. follow-up telephone Although it has been known for many March meeting, got a from Earl Parnum, a he said in a recent interview. call four months later On March 23, Dr. Perry J. Oehrlg, Dow's years that Dow held the 1965 meeting with Dow its competitors, excerpts from corporate wrote executive. Dr. Frawley immediately vice president for agricultural research and a confidential memorandum to- the development and director of health and enmemorandums about the session are only file. now beginning to emerge as a result of a I Mr. Parnum, he wrote, said he was calling vironmental science, cautioned the House lawsuit filed in 1979 against Dow and sever- (jn behalf of a Dow vice president, Donald. Subcommittee on Natural Resources, Agriculture Research and Environment against al other chemical companies. The memoran- Baldwin, and "stated Dow was exdums raise the possibility that Dow scien- tremely frightened that that situation might "overinterpreting" the Swedish studies. The this reports, he argued, "are too incomplete, tists have been saying one thing in private explode." both individually and in aggregate, to curabout dioxin while the company's manage"They are aware that their competitors rently formulate a clear picture of the possiment has said something else in public. are marketing 2,4,5-T which contains ble associations between TCDD and soft"There Is absolutely no evidence of dioxin Frawdoing any damage to humans except for 'alarming amounts' of acnegen," Dr."and if tissue sarcomas." TCDD is a form of dioxin. continued, referring to dioxin, something called chloracne," Paul F. Oref- ley Government learns about this the whole In 1982, Dow scientists published a report the fice, the president of Dow. said last month industry will suffer. They are particularly of a company survey on the occurrence of on NBC's "Today" show. "It's a rash." Dow fearful of a Congressional investigation and spontaneous abortions, stillbirths, infant has performed medical tests on individuals excessive restrictive legislation on the man- deaths and several categories of birth desuffering from chloracne for "over 20 ufacture of pesticides which might result." fects among the wives of Dow workers who years," he added, "and there is no evidence .A second memorandum written by Dr. had been directly exposed to dioxin. The of any damage other than this rash which Frawley, and quoted in part by lawyers for . study concluded there were few differences went away soon after." in the.number and kind of birth abnormalisaid Dow's critics challenge the accuracy of the veterans,about he had just received new ties found in these women compared with information health effects of dioxin the wives of Dow workers not exposed to Mr. Oreffice's flat assertion that there is no from Monsanto, a evidence that dioxin causes human damage sentative to thewhich did not senttherepre- dioxin, and the report has been used fremeeting. "From data other than chloracne and also charge that provided, a sample which contained 5 parts quently to support the theory that dioxin is Dow has failed to publish all the informa- per million would be acutely toxic," he not as dangerous as generally believed. tion it has collected in its own dioxin re- wrote. "Whether this refers to death or But Dr. Marvin 8. Legator, professor and • search. Furthermore, they say, Dow has sys- liver damage is not clear." director of environmental toxicology at the tematically resisted Federal and state ef- .Daniel Bishop, a Monsanto spokesman, University of Texas in Galveston, questions forts to learn about and regulate dioxin. the study. that According to a pretrial motion filed by said in an Interview period, his company "Initially," Dr. Legator went on, "Dow "didn't'do any testing, not then and Yannacone & Associates, the legal organiza- not now." He said that a fair reading of Dr. planned on comparing the birth defects tion created to represent the Vietnam veter- Frawley's full statement would make it clear among the wives of Dow dioxin workers ans In the Agent Orange case, the 1965 that he had not received the toxicity infor- with two controls. First, a group of wives of meeting on dioxin was attended by eight of was not able to Dow workers in Midland who had not been Dow's senior scientists and six officials of mation from Monsanto, but source because directly exposed to dioxin, and second, some identify the information's Booker Chemical; the Diamond Alkali Com- the material In the Agent Orange case had wives of workmen who lived outside the pany, which later became part of Diamond been sealed by the judge. The documents Midland area. This second control group Shamrock, and the Hercules Powder Com- were sealed at the chemical companies' re- was important because the Midland area is pany. A representative of the Monsanto quest. quite polluted and the general population Chemical Company was invited but did not has a relatively high level of congenital abCROOT or 78 COMPOUNDS attend. normalities. But when they published the Dioxin is the name given to any of a study the second control group was not inDonald R. Frayer, a spokesman for Dow, confirmed in an interview April 6 that the family of 75 compounds, called dibenzo- cluded." giant chemical company had called the para-dioxins, composed of benzene mole* A "SAMPLING PROBLEM" meeting to discuss the health hazards of cules and oxygen atoms. The compounds are Mr. Frayer, the Dow spokesman, said the dioxin. "We feel the meeting was pretty an unwanted byproduct of several chemical darn straightforward and proper," he said, processes, including the manufacture of second group had been deleted because of • "I think on the balance that the record 2,4,5-T under certain circumstances; 2,4,5-T "sampling problems." shows we discovered a problem, sought out is one of the two major components of "The women could not be compared with our competitors and tried to give them in- Agent Orange. those hi the first two groups, and they were Proving the specific effects of toxic chemi- questioned in a different way," Mr. Frayer formation and a means to control the probcals OB humans is extremely difficult; •aid. --v . - . - ,-.- o 3-7 �E1682 CONGRESSIONAL RECORD — Extemiom Information compiled by Dr. Alvin Young, an expert at the Veterans Administration, Indicates that from 1991 to 69 American companies made a total of 154.5 million pounds of 2,4,5-T. Of that total, 44 million pounds were applied to the jungles of Vietnam, 23.4 million pounds were exported to other countries and 78.1 millionpounds were used domestically. The balance, 10 million pounds, was destroyed by the Government after it was decided to halt the Vietnam defoliation program. Dr. Young estimates that 1,700 pounds of dioxln a year Were produced in the United States from the mid-1950's to about 1975. when steps were taken to limit it through changing the manufacturing process. There is broad agreement that a substantial portion of dioxin-contaminated wastes are burled in thousands of dumps around the country. The Environmental Protection Agency recently said there were 12,000 of these dumps. Other experts have estimated the number may be closer to 60,000. , SUITS AGAINST COMPANIES not of the subject of the meetings, is contained in the calendars and travel records of these officials that have been obtained by the House subcommittees investigating the agency. Anne McGill Burford, for example, made at least two trips to Midland, Mich., in her 22 months as the head of the Environmental Protection Agency. Rita M. Lavelle, the former head of the Government program to clean up toxic waste dumps, met at least 14 times with Dow officials in the 11 months she held office. Mrs. Burford, Miss Lavelle and 11 other •political appointees recently resigned or were dismissed amid Congressional inquiries on allegations that the agency's toxic waste program had been mishandled. According to the public testimony of some officials of the agency, Dow used its connections with the top echelon of the agency's Washington officials to get its way on several important matters relating to the regulation of dioxin. Three weeks ago, for example, agency officials in Chicago told the Investigations Subcommittee of the House Committee on Energy and Commerce that their superiors hi Washington ordered them to change an inportant report on dioxin to comply with the wishes of Dow. The key deletion from the report was the following central conclusion about Dow's Midland plant: "Dow's discharge represented the major source, if not the only source, of TCDD contamination found in the Tittabawasse and Saginaw Rivers and Saginaw Bay in Michighan."* Billions of dollars are at stake In the answer to the question of what the chemical companies knew and when they knew It. In addition to the tens of thousands of veterans who have sued the chemical companies because of their exposure to Agent Orange in Vietnam, thousands of other Americans living near toxic dumps, such as the one in the Love Canal area of Niagara Falls, N.Y., are seeking damages on the grounds that dioxin and chemical poisons left there have shortened their lives and caused cancer, birth defects and genetic damage. In January 1079. a group of veterans brought a Federal suit in New York, charging that the dioxin contained in the 2,4,6-T PULITZER PRIZE TO THE sprayed in Vietnam was a cause of cancer BOSTON GLOBE and other diseases among their members and had resulted in genetic damage and the birth of severely deformed children. HON. EDWARD^. MARKEY Victor John Yannaeone, Jr., a principal ^^^ OF MASSACHUSETTS organizer of the association of lawyers hanIN THZ^IgUSE OF REPRESENTATIVES dling the class-action suit. Bald In a recent interview that the group now represents TuesOqg, April 10,1983 20,000 Vietnam veterans, widows and chilMr. MARKETJsMr. Speaker, yesterdren of veterans who are seeking damages y, the Pulitzer vt^lze Board made against the chemical companies that provided the Government with Agent Orange. own its selections f&lkthe recipients The suit against Dow and the other major the 67th annual FWtzer Prize manufacturers of 2,4,5-T Is scheduled to go ards for outstanding j^u-nalism. to trial in the Uniondale, L.I.. court of Fedlected as one of the wlnnete from. eral District Judge George C. Pratt Jr. in ong more than 1,200 entries* June. que and brilliantly crafted fea15 In an annual report filed with the Securioduced by the Boston Globe. En} ties and Exchange Commission in Washington called a 10-K, Dow said it was one of six "War and Peace in the Nucla chemical companies who were defendants in e," this special supplement to/he the suit. "Dow believes it has not been sciday, October IT, 1982. issue of/the entifically demonstrated that the injuries ton Globe was chosen for/this claimed by the plaintiffs were caused or tigious honor in the category of could have been caused by exposure to ational affairs reporting. Agent Orange," the report Mid. I can think of no piece of jou/halism ' The Dow report also noted that the chemical company was opposing a move by et produced on the urgent/opic of the Environmental Protection Agency initi.e nuclear age more deserving of the ated during the Carter Administration that ignition it has now received. Spewould totally ban the use of 2,4,6-T in the ial credit should be giv/n to the United States. The herbicide therefore is tperb ofitichael C. still being used on rice fields, on range lands anewayediting workK. Kpng who diand Harry and In industrial areas such as refineries, to eted the impressive assemblage of an control weeds. . • :cellent series of articles and illustraThe company's repeated public stateons on this topic. ments about the comparative safety of dioxin, Including testimony to CongressionThe people of Massachusetts are al committees, press releases and scientific uly among the m<m politically sopapers, have been accompanied by efforts isticated citizens/of the Nation, on its part, particularly in the Reagan Adey have been at (ne forefront of tmministration, to block the Government from rtant political/issues repeatedly collecting information about the contamithroughout the hmtory of our Nation. nant. - . Evidence of the repeated contacts between Indeed, the recent reawakening of the Dow and E.P.A. officials in Washington, if ile of America to the peril of the ApiHlB,1983 Remarks uclear arms race had Its roots In the ninds and actions of the people of the Commonwealth of Massachusetts. The preeminent newspaper of the Northeast and one of the truly outnewspapers in the'country, he Boston Globe, deserves a great leal of credit for providing to its readrs consistently excellent journalism rhich enables them to become responible and effective citizens. The Puliter Prize truly redeems credit well deerved. In introducing its special supplenent, the editors left this message rith the reader: We offer in the pages that follow some inreductions to the nuclear arms debate. 2ach piece of the nuclear-arms jigsaw uzzle requires its ow» short guide, or landle. We have tried 0 make key parts of tie discussion plain, and also to point where he discussion is heading. The effort is not o be encyclopedic, jbr to preach or precribe. It is to encourage the fresh, cleansng process of public education and debate bout a matter otflte and death for manjnd. ! in the Nuclear Age" "War and the most significant s surely one ontributions Journalistic entity las made in at years toward eduabout the urgent sating Amer hreat of nuflear war. I sincerely hope hat by receiving this well-deserved iward bestowed by the most prestigous orgamzation in professional journalism that many more Americans will now have the opportunity to read and learn fnm the Boston Globe's excellent wfrk. I congratulate the Boston Globe/for earning this honor and for Its at/ention to so important a topic.* MUST BE A PARTIN OUR NATION'S REICH EFFORT HON. TIMOTHY E. WffiTH OF COLORADO IN THE BOUSE OF REPRESENTATIVES Tuesday, April 19,1983 Mr. WIRTH. Mr. Speaker, I have ig been concerned about declines in oil*,, national investments in research and development, and have worked for years 10 reverse this dangerous trend. At a tinWwhen more than ever before in our htyory, the future economic health of tte United States relies on our ability tcroiaintain our traditional distinction as <%e ideal capital of the world, we need V new concerted national effort to continue to lead the way in high technoWy and information industries. In thi¥jncreasingly international economy these fields offer us hope for developing aTtealthier balance of trade. They alsoTiave enormous job potential for our olgi economy. Maintaining our lead in higHStechnology industries like electronics, photovoltaics, telecommunications, and many others will require a greatly improved national research base. Gov- �Offire of the Administrator of Veterans Affairs Washington, D.C. 20420 f>j?jfp:r /?/ f/'fr/r* ' Veterans Administration Honorable G. V. Montgomery Chairman, Committee on Veterans' Affairs House of Representatives Washington, D.C. 20515 D'^ar Mr Chairman: I am pleased to present the views of the Veterans Administration oil n.R. 196.1, 98th Congress, the proposed "Vietnam Veterans Agent Orange Relief Act." I t,l>are with you and other members of Congress the desire for a meaningful Federal response to the fears of veterans who served in Vietnam that their exposure to Agent Orange may have, long-term adverse effects on their health. However, we consider the approach taken ii. K.R. 1961 inadvisable given the present state of scientific knowledge. The controversies arising from the Government's use of Agent Orange in Vietnam are a long way from resolution. Some of them may never be resolved. Before turning to the Veterans Administration's observations concerning the several issues raised by H.K. 1963., I would like to emphasize that the potential cost of paying compensation based on any AgentOrange-caused disabilities played no part in our deliberations on this measure. The Federal Government, since its beginning, has fulfilled its sacred obligation to veterans disabled in the line of duty and will continue to do so. The devastating wars of this century, and the need to maintain peacetime forces in order to assure the defense of our Nation, have been accompanied by legislative and programmatic developments intended to assure that no veteran's reasonable claim to compensation is denied. This is true whether the disability results from a combat wound, service-incurred resulting or have adverse health effects. We are immensely proud of our Agency's record of achievement. It can safely be maintained that our compensation program is the finest in the world, both in terms of the number of 3-9 �2. Mr. Chairman w veterans we serve and in the amount of benefits paid. Moreover, the American people—who fund this program with their taxes—have given it overwhelming support, &s has the Congress of the United States. The preservation and integrity of tho compensation program are among the highest priorities o£ the Veterans Administration. There are certainly many veterans suffering from illnesses they ascribe to exposure to that herbicide, especially its contaminant dioxin. There are persons in the medical and scientific communities who contend that exposure may lead to a host of disorders that appear long after the exposure has ceased. There are alsu organizations and individuals who believe very sincerely that the Veterans Administration has not responded adequately to the issues involved. As guardians of the public trust, Congress and the Administration share, I believe, a commonality of aims respecting these issues. The compensation program must be attuned to justifiable conclusions about the connection between Agent Orange exposure and disorders possibly arising from that exposure. At the same time we nus'c. do our best to avoid taking steps that have the potential for undermining the program's credibility and legitimacy. I know that you and other Members will give careful and thorough consideration to the bill, keeping in mind the commonality of aims to which I have previously alluded. K.R. 1961 is intended to assist veterans who served in Southeast Asia during the Vietnam era establish entitlement to service-connected disability compensation if they are currently suffering from one of the disorders specified in the bill. It would do this by amending section 312 of title 38, United states Cede, in order to provide for a special presumption of service connection applicable only to these veterans. The bill is based on the premise that each of the specified disorders, no matter how long after military service symptoms appear, can be attributed to exposure to a phenoxy herbicide 3-S0 �3. Mr, Chairman in "service. During the period 1962 to 1971, phenoxy herbicides, including Agent Orange, were uted in Vietnam. As I have noted, H.R. 1961 ic an effort to respond to the widespread concern that exposure to Agent Orange, especially its contaminant, dioxin, may have long-term adverse effects on veterans' health. Authority to award compensation on the basis of the presumption provided for in the bill would terminate one year after submission to Congress of the comprehensive epideniological study mandated by Pub. L. No. 96-151. This "sunset" provision ic analogous to the sunset provision applicable to VA health care for certain disorders possibly associated with phenoxy herbicide exposure, authorized by Pub. L. No. 97-72. Both sunset provisions recognize the current uncertainties as to the long-term adverse effects of exposure. The Agent Orange controversy, as it relates to individual veterans' compensation claims, involves two basic questions: (1) whether the veteran was exposed, and (2) whether the veteran's disability results from the exposure. H.R. 1961, it should be noted, does not require any evidence of exposure; it would afford the presumption to any veteran who served in Southeast Asia during the Vietnam era (1964-1975). We have previously made public our decision to resolve the issue of exposure in a manner favoreible to veterans; unless there is affirmative evidence to the contrary, we are prepared lo presume exposure if a veteran served in Vietnam during the relevant period. This policy, prompted by the lack of a definitive method for identifying exposed individuals, is consistent with our longstanding policy of giving veterans the benefit of the doubt. There may be, however, some cases in which affirmative evidence refutes even the possibility of exposure, and, therefore, our policy is necessarily qualified. The lack of any similar qualification in H.R. 1961, in our view, is unjustifiable. We observe also thac affording the presumption to veterans who served in Southeast Asia—a far broader region than Vietnam, embrccif 7 areas where no phenoxy herbicides were used—inappropriately expands the category of veterans intended to be benefited. Our principal concerns, however, relate to the concept of an open-ended presumption that would be established by the bill and to the conclusions it embodies as to the specific disorders chloracne, porphyria cutanea tarda (PCT), and the several malignancies grouped as soft-tissue sarcoma. The bill would also authorize presumptive service connection for additional disorders, provided for by regulation, that medical research has shown may be attributable to chemical exposure or environmental hazards or conditions. 3-/I �4. Mr. Chairman The post-service presumption periods provided for in section 312(a) of title 38 are appropriate for chronic diseases whose inception in service may not be recorded because the development of pathology is gradual and insidious. They are justifiable when reasonably supported by medical knowledge as to the pathological courses of the particular diseases. Congress has wisely set time limits on these presumptive provisions; unless symptoms of the disease appear within a specified period of time after service, the presumption is not available. The section 312(a) presumption, together with the time limits, assures that no veteran's reasonable claim is overlooked but also does not dictate grants of service connection when there is no evidence of service incurrence and it is not reasonable to infer service origin. Reputable studies have concluded that dioxin exposure may result, within a relatively short period, in chloracne. PCT resulting from exposure also appears within a few weeks. On the other hand, no studies have shown that exposure results in the initial appearance of these disorders after lengthy delays. Our current authorities are adequate, without the need of a presumption, to award service connection and compensation, if appropriate, in cases of chloracne or PCT appearing within expected time limits after the exposure. Requiring us to award service connection for initial occurrence of these disorders long after the exposure incidents isf we believe, unjustifiable in the absence of any evidence indicating they are latent effects of exposure. As I have noted, individuals in whom these relatively rare disorders appear begin to suffer symptoms soon after exposure, ordinarily within days or weeks. Chloracne is a skin disorder caused by exposure to certain chlorine-containing chemicals, including dioxin. In its more serious manifestations, it causes discomfort and disfigurement. Most cases clear up within a year or two after the exposure ceases, but in a few, the disorder persists. The Veterans Administration acknowledges that chloracne can result from exposure to Agent Orange during service in Vietnam and has established procedures to assure careful and liberal consideration of all claims based on this disorder. Since 1978, we have awarded service connection in 1,225 skin-disorder cases involving veterans who served in Vietnam. We have scrutinized more than 3,000 claims for service-connected benefits to determine whether there are indications of chloracne. Those cases in which it was believed this diagnosis was at least possible were further reviewed by a VA dermatologist, and 13 have been examined in person by dermatologists at prestigious private clinics. �5. Mr. Chairman Although c,ll of these cases involve skin disorders of various types and all involve veterans who served in Vietnam, only one case of possible chloracne has been identified. We will, of course, continue our investigations of this issue. H.R. 1961 would also extend presumption of service connection for "chioracnefonn lesions." This is a term not found in medical or scientific literature, but can be taken to mean "lesions resembling chloracne." As certain common skin disorders may resemble chloracne, this term is overly broad and would, we believe, causa unnecessary confusion. PCT, an uncommon livtr disorder, can be triggered by exposure to various chemicals including alcohol. There is no evidence that PCT is <A latent effect of exposure. Each attack ordinarily subsides in about a year after contact with the chemical ceases, but prolonged exposure, as in chronic alcoholism, may cause permanent danage to the liver. An attack of PCT induced by Agent Orange or exposure to any other chemical during service in Vietnam years ago would not be expected to impair a veteran's health today. As is the case with chloracne, we regard our current authorities as fully adequate to assure proper consideration of PCT claims based on exposures during military service. As a technical matter, the proper application of section 313 of title 38, United States Code, making section 3.12 presumptions rebuttable if there is evidence of an intercurrent cause, would reduce the likelihood of awards of service connection based on the PCT presumption, if enacted. The issue as to whether the malignancies grouped as "softtissue sarcomas" result from phenoxy herbicide exposure presents a problem of far greater complexity. There is considerable uncertainty in the scientific community on this issue. Advocates of the belief that exposure "causes" softtissue sarcoma generally cite studies involving cancer victims believed to h&ve been exposed to phenoxy herbicides whose first symptoms appeared long after the exposure. Because it is well established that exposure to radiation and other agents like asbestos and benzene may result in the latent development of malignancy, these advocates reason by analogy that phenoxy herbicide exposure "causes" soft-tissue sarcoma. The vitaj question is, therefore, the weight that should be given to the studies they cite. "Soft tissue sarcomas" are a group of malignant tumors, or cancers. Any sarcoma arises in a body cell that does not cover a body surface, form glandular tissue, or line certain body cavities. "Soft tissue" excludes sarcomas in "hard tissues" such as bone or cartilage. Hence, soft tissue sarcomas arise from such body tissues as muscles, tendons, blood vessels, fat, and connective tissues. 3-/J �6, Mr. Chr.irman Certain cancers share some characteristics of soft-tissue sarcomas but are not placed in that group. These include most brain tuirors and the so-called blood cancers, chiefly the leukemias. Sone authorities include tumors of the lymph nodes—the lymphoruas—with the soft-tissue sarcom&s. The World Health Organization "International Classification of Tumors, No. 3, Histological Typing of Eoft Tissue Tumors," however, excludes lywphomas and appears to be adequate for purposes of defining the malignancies in this category. There is no evidence that all soft-tissue sarcomas have a common etiology or cause. These malignancies differ from one another as Lo how rapidly they grow and spread, how they are treated, and the results that treatment achieves. However, all are considered lethal if not successfully treated. These malignancies are rare. According to the National Cancer Institute, they comprise 2.76 percent of all cancer cases in men aged 25 to 29 and 0.58 percent of all cancer cases in men aged 55 to 59; the percentage declines because other types of cancers become increasingly common with age. Lymphomas, sometimes included with soft-tissue sarcomas, contribute another 5.21 percent at ages 25 to 29 and 2.40 percent at ages 55 to 59. Although th^re is no evidence establishing a common cause for these sarcomas, some malignancies in the group are known to be associated with exposure to environmental hazards. For example, malignant mesothelioma is knov/n to be caused by asbestos exposure, and angiosarcor.a of the liver by exposure to vinyl chloride. Because these malignancies are raie, it is difficult to devise adequate techniques to investigate their causes. A series of studies in Sweden using the "case/control" method grouped the soft-tissue sarcomas together in order to investigate whether Swedish foresters and farmers exposed to herbicides and a chemical known as chlorophenol in their work, suffered latent malignancies of this type. These studies have been carefully reviewed by Richard D. Remington, Dean of the School of Public Health, University of Michigan, at the request of the Office of Technology Assessment and determined to have been carefully conducted and wall reported with results that suggest a relationship between herbicide exposure anci soft-tissue sarcomas. Significantly, Dr. Remington pointed out the limitations of the case/control methodology and found the Swedish studies inadequate to permit definite conclusions. v Investigations in the United States based on studies of industrial workers have also suggested a phenoxy-compound connection with soft-tissue sarcowas. In addition, an East German investigation of malignant neoplasms among pesticide �7. Mr. Chairman «•• sprayers and agricultural technicians tends to support the Swedish studies by finding a single case of soft-tissue "malignancy," which probably was a soft-tissue sarcoma. Other studies, in Finland, New Zealand, Great Britain, the Netherlands, and Italy have not confirmed the Swedish studies. In addition, a separate investigation of Swedish forestry workers casts some doubt on the Swedish studies. We do not disagree with Dr. Remington's conclusions as to the credibility and limitations of the Swedish studies. They lay a predicate for further investigation and do not rule out the possibility of a causal link. They do not, however, provide a reasonable basis upon which to favorably decide VA compensation claims. We recognize the importance of careful scientific analysis in matters of this kind, and have appended to this report detailed background papers concerning these diseases. The comprehensive epioemiological study mandated by Pub. L. No. 96-151, together with other ongoing studies including soine devoted specifically to the soft-tissue sarcoma issue, may resolve many of the controversial questions raised by the use of Agent Orange in Vietnam. As I stated at the outset of this report, we must work toward the dual objectives of fair compensation for any Agent-Orange-causod disabilities and avoidance of steps that would compromise the integrity of the program. At this point, there is no evidence that either chloracne or PCT is a delayed effect of exposure, and we believe the provisions of H.R. 1961 respecting these disorders are not justified. We do not believe it has been satisfactorily demonstrated that exposure can cause soft-tissue sarcoma. Accordingly, we oppose the enactment of H.R. 1961. In view of the current state of scientific findings, enactment would compromise the integrity of tha compensation program and engender unfounded Cears among Vietnam veterans that lethal illnesses may yet befall them as a result of having answered duty's call. Our biding moral obligation to veterans who have given so much demands that we act responsibly in all matters affecting the compensation program. If the soft-tissue sarcoma presumption in H.R.- 1961 were to be enacted, we estimate compensation benefit costs in fiscal 3-1 �8. Mr. Chairman year-1984 ranging from $2 million to $11 million, with the range for DIG benefits $3.5 million to $18,7 million. Benefit costs for future fiscal years would be comparable. A range of estimates is necessary because of uncertainty as to which malignancies are to be covered. Administrative costs would be sizeable in the first fiscal year and are anticipated to be $6.2 million, but would level off during subsequent fiscal years to less than $600,000 in fiscal year 1988. Costs relating to chloracne are estimated as insignificant. We can only speculate with regard to costs resulting from the inclusion of "chloracneform lesions." As PCT is a relatively uncommon disorder, we would not anticipate benefit costs exceeding $1 million in any fiscal year from the PCT presumption. �CHRONOLOGY OF SIGNIFICANT EVENTS PERTAINING TO THE AGENT ORANGE ISSUE Oct 1977 A non-medical VA employee became convinced that Agent Orange caused wide variety of disabilities among Vietnam veterans, prompting them to file claims for compensation in late 1977. March 1978 Chicago TV program on adverse effects of Agent Orange featured supposed cases of such effects supplied by the employee and suggesting the filing of claims. April 1978 First meeting of herbicide consultants with prior experience that related to Agent Orange matters. Subsequent meetings were held in July and September to evaluate the current state of knowledge about phenoxy herbicides and their contaminants. DVB issued "Rating Practices and Procedures: Disability, Vietnam Defoliant Exposure" PG 21-1, Change 259, Section 0-18, to guide VA ROs in processing claims for disabilities resulting from chemical defoliants in Vietnam. All rating claims were to be reviewed in VACO. May 1978 Telephone "Hotline" discussion of Agent Orange situation between Hospital Directors, Chiefs of Staff and VACO. DM&S distributed to all medical facilities a teletyped release "Potential Exposure of veterans to Chemical Defoliants During the Vietnam War." This release established the basis for the "Agent Orange Registry" and the examination of concerned veterans, it also began the process of providing information to VA personnel dealing with defoliant problems. June 1978 First meeting of the VACO Steering Committee on Herbicides that met until July 1980, to coordinate the activities of the various VACO components involved in the Agent Orange problem. �July 1978 Aug 1978 Sept 1978 DM&S prepared brief brochure, "Biological Actions" of Herbicides Used During the Vietnam War" for guidance of medical staff and directors. DM&S concluded agreement with Armed Forces Institute of Pathology (APIP) to establish a Special Registry to collect and examine all types of biopsy and autopsy material from veterans claiming exposure to Agent Orange. Circular 10-78-219, "Possible Exposure to Veterans to Herbicides During the Vietnam War," directed VAMCs to establish a registry of Vietnam veterans receiving Agent Orange-related physical examinations. The registry established on card file on concerned Vietnam veterans and a medical record of the pertinent history and examination results. VACO staff briefed the Washington staffs of veterans organizations on herbicides used in Vietnam and VA's work on the Agent Orange problem. DM&S issued Circular 10-78-234, "Special Registry" directing VAMC's to provide specimens to AFIP for study. Decision made to request approval for the establishment of an advisory committee. Oct 1978 Congressional Hearing. DM&S reported current information and activities to the Subcommittee on Medical Facilities and Benefits of the House Veterans' Affairs Committee. Feb 1979 Announcement that a surgical method for checking whether some Vietnam veterans carry after-effects of Agent Orange in their body fat will be tested by the VA. The test is part of a VA search for a simple way to find whether any Vietnam veterans might have after-effects from exposure to herbicides in Vietnam. April 1979 Charter issued authorizing establishment of the VA Advisory Committee on Health-Related Effects of Herbicides, in accordance with Public Law 94-463. -2- �"" VACO staff met with Professor Ton That Tung ofVietnam, who has conducted research on effects of Agent Orange on Vietnamese. Circular 21-79-6, "Assistance to Agent Orange Exposure Claimants,11 established DVB procedures for providing assistance to veterans claiming disabilities resulting from exposure to herbicide orange. May 1979 VA, in a news release, lauded a DOD decision to do an in-depth follow-up on 1,200 Vietnam veterans who were heavily exposed to Agent Orange while involved in spraying operations in Vietnam. The 1,200 people handled and sprayed Agent Orange during air missions known as "Operation Ranch Hand." Data on their health will be matched to a larger group not exposed. June 1979 The establishment of a veterans Administration Advisory Committee on Health-Related Effects of Herbicides was announced. The Committee, which included representatives nominated by government, veteran organizations, and academic sources, monitors VA's continuing inquiry into the possible health effects of Agent Orange on veterans who served in Vietnam. The Advisory Committee first met in June 1979. Subsequent meetings have been held on a quarterly basis. Congressional Hearings. Subcommittee on Oversight and Investigations of the House Committee on Interstate and Foreign Commerce held hearings on "Involuntary Exposure to Agent Orange and other Toxic Spraying." VA was not requested to appear. Sept 1979 First Educational Conference held for physicians in each VA facility who are in charge of examining veterans claiming possible exposure to Agent Orange. Dec 1979 Congress, in section 307 of Public Law 96-151, directed the VA to design a protocol for and -3- �Conduct an epidemiological study of persons who, while serving in the Armed Forces of the United States during the period of the Vietnam conflict, were exposed to any of the class of chemicals known as "the dioxins" produced during the manufacture of the various phenoxy herbicides (including the herbicide known as "Agent Orange") to determine if there may be long-term adverse health effects in such persons from such exposure. A comprehensive review and scientific analysis of world literature covering studies relating to long-term adverse health effects in human from exposure to dioxins was also mandated by this legislation. The White House announced the establishment of an Interagency Work Group to Study the Possible Long-term Health Effects of Phenoxy Herbicides and Contaminants. The group included representatives from VA, HHS, and DOD, and observers from several other agencies. Feb 1980 Initial meeting of Interagency work Group held. Administrator testified on Agent Orange before the Senate Committee on Veterans' Affairs and the Subcommittee on Medical Facilities and Benefits of the House Committee on Veterans' Affairs. A news release was issued which outlined the Administrator's testimony of results obtained in a VA study of the levels of dioxin in the fat of veterans known to have been exposed to Agent Orange as compared to a control group of unexposed veterans. March 1980 The VA issued an RFP requesting firm fixed-price offers for the required protocol design. Spring 1980 VACO officials visited a series of major cities (Chicago, New York, Los Angeles, Boston) to brief VAMC and VARO personnel on Agent Orange activities. -4- �April 198J) The Interagency Work Group agreed that Centers for Disease Control (CDC) conduct a retrospective case control study to determine whether Vietnam veterans may have a higher risk of producing children with birth defects. Costs are to be borne by HHS, DOD, and VA. Office of special Assistant to Chief Medical Director for Environmental Medicine (102) established to coordinate DM&S Agent Orange program and related matters. May 1980 The Policy Coordinating Committee (PCC) was established by the Administrator, under the chairmanship of the General Counsel, to serve as a central focal point within the agency to review all aspects of Agent Orange activities within the VA and to recommend, develop and establish new policy initiatives. Second Continuing Education Conference on Herbicide Orange was held in Washington, D.C. Attendees included 180 VA environmental physicians and 58 adjudication officers who were updated on VA Agent Orange-related activities and provided an overview of significant scientific and medical information concerning this defoliant. National Veterans Law Center sought court order prohibiting VA from opening bids received for the epidemiological study design contract. Court denied the request. VA reviews bid received. VACO DM&S spokesman testified before committee of New York State Legislature regarding Agent Orange. Subsequent testimony was given before state legislative committees in Minnesota and California. June 1980 In recognition of the concern expressed by veterans regarding chloracne, a skin condition resulting from exposure to Agent Orange, a special Chloracne Task Force (CTF) was established by the Chief Medical Director. The activities of the CTF are monitored by the Office of Environmental Medicine (102). Responsibilities assigned to the CTF-include the ongoing review of skin conditions reported by -5- �Vietnam veterans which may be chloracne and to make recommendations on questionable cases for further examinations. District Court referred National veterans Law Center bid protest to GAO for review. A Special Data Analysis Task Force was established to review activities of the VA's Agent Orange Registry and to recommend and implement the streamlining of statistical reporting procedures. The Task Force meets twice monthly to improve the registry process and the quality of retrieved data obtained from the examination of concerned Vietnam veterans. VA pamphlet, "Worried about Agent Orange?" published and forwarded to all field stations for mass distribution to Vietnam veterans, their families, and others concerned about possible effects of exposure to Agent Orange. VACO Office of Planning and Program Evaluation completed report on the Minnesota Agent Orange Outreach Program. (Minnesota had implemented most extensive AO outreach program in the nation). July 1980 Congressional Hearing. Subcommittee on Medical Facilities and Benefits of House Committee on Veterans' Affairs held an oversight hearing on Agent Orange. No VA testimony. , Sept 1980 Hearings of the Senate Committee on Veterans' Affairs; the Subcommittee on Medical Facilities and Benefits of the House Committee on Veterans' Affairs; and the Subcommittee on Oversight and Investigation of the House Committee on Interstate and Foreign Commerce. The VA testified before all three committees. The. Administrator delivered the testimony before the Committee on Interstate and Foreign Commerce. VA signed interagency agreement with HHS and DOD to provide total of $338,400 in FY 1981/1982 (1/3 of total cost) for CDC birth defects study. -6- �Workshop on "Impact of Chlorinated Dioxins and Related Compounds on the Environment", held in Rome, Italy with participation of Office of Environmental Medicine. Dec 1980 The Office of Environmental Medicine conducted a nationwide conference call with key field station officials regarding Agent Orange. The VA awarded contract to JRB Associates, Inc. of McLean, VA, to conduct a review and analysis of world literature on herbicides used in .Vietnam. Effort was mandated by Public Law 96-151. Initial issue of Agent Orange Bulletin. Publication established to advise VA physicians and medical staff responsible for Agent Orange activities at VAMC's with information regarding recent developments. Jan 1981 VA film, titled "Agent Orange — A Search for Answers," was distributed to VAMCs, clinics and regional offices as part of a nationwide VA program to bring to concerned Vietnam veterans the latest scientific information on Agent Orange. The program was produced by the South Central Regional Medical Center in St. Louis, with technical assistance from the Office of Environmental Medicine (102). The production has earned an "Emmy" and several other awards. GAO denied National Veterans Law Center protest concerning epidemiological study design contract award procedure. Decision allowed VA to proceed on contract award. March 1981 The Office of Environmental Medicine conducted first of a series of regularly scheduled nationwide conference calls with key field station officials on the subject of Agent Orange. Subsequent calls have been held or} a bimonthly basis. .7 V-7 �April 1981 "" Charter of VA 'Advisory Committee on • Health-Related Effects of Herbicides renewed. Committee extended for two years. First of series of mailouts sent to all environmental physicians to ensure that they have updated information on Agent Orange-related matters. April/May 1981 Hearings of the Subcommittee on Hospitals and Health Care of the House Committee on veterans' Affairs; the Senate Committee on Veterans' Affairs; and the Subcommittee on Oversight and Investigations of House Committee on Veterans' Affairs. VA testified before a}.l three groups. May 1981 VA announced the award of a $114,288 contract under which Drs. Gary Spivey and Roger Detels of UCLA's School of Public Health would design an epidemiological study. The study was mandated by Congress in December of 1979 and VA issued a request for proposals to design it in March of 1980. Legal objections raised by the National Veterans Law Center delayed award of the design contract until this time. July 1981 The Agent Orange Working Group was established at the Cabinet Council level. This reconstituted committee was formerly designated as the Interagency Group to Study the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants (IWG). The lead agency for the working group is DHHS. Major Alvin L. Young, USAF, an expert in herbicides, was detailed to VACO for two years to assist Office of Environmental Medicine. Aug 1981 The Administrator formalized the ad hoc Agent Orange Policy Coordinating Committee established in May, 1980. Under this arrangement, the committee was elevated and the Deputy Administrator appointed Chairman. The Committee is currently composed of representative —8 — �from DM&Sr DVB, Office of General Counsel, Office of Information Services and Office of Planning and Program Evaluation. First meeting of the newly constituted Agent Orange Working Group. DHHS Secretary Schweiker unexpectedly announced that :*gent Orange was jettisoned during aborted spraying missions in Vietnam. The information provided some additional detail to that already in public domain, but produced increased anxiety among many Vietnam veterans and their families. VACO officials met with hunger strikers at VAMC Wadsworth. VACO announced solicitation of research proposals dealing with the effects of animal and human exposure to Agent Orange and Agent Blue with emphasis on delayed effects. Solicitation limited to VA researchers. Preliminary epidemiological study design submitted by UCLA. Sept 1981 Contract to conduct the questionnaire for CDC birth defects study took effect. (Contract was signed in August). The pilot study is scheduled for completion by March 1982, with the main study scheduled for completion by April 1983. Air Force contract awarded to Louis Harris and Associates to administer questionnaire for Ranch Hand epidemiological study. The study will assist in determining whether a causal relationship exists between exposure to Agent Orange and changes in the long-term health status of Air Force personnel known to have been extensively and repeatedly exposed to this herbicide as part of spraying mission in Vietnam. Oct 1981 International Dioxin Symposium held in Arlington, VA. Office of Environmental Medicine aided in organization of this scientific meeting. Many environmental physicians participated in the symposium. -9- �Oct/Nov 1981 Agent Orange Work Group Science Panel, Office of Technological Assessment, and VA Advisory Committee on Health-Related Effects of Herbicides completed review of epidemiological submission. Responses sent to UCLA. Nov 1981 Public Law 97-72 provided for medical treatment for disabilities that may be related to exposure to Agent Orange. Law amended P.L. 96-151 to allow expansion of scope of epidemiological study and literature review. Circular 10-81-249, issued providing interim guidelines for implementation of Agent Orange medical care provisions. Administrator testified before the Senate Committee on^/eterans' Affairs concerning agency Agent Orange-related activities. VA began distribution to researchers throughout government and the scientific community, a compilation of world scientific literature on Agent Orange and other herbicides used in Vietnam. Dec 1981 The Federal Register published interim guidelines (Circular 10-81-249) pertaining to treatment of veterans exposed to Agent Orange. Comments, suggestions, and objections were welcomed. The Kelsey-Seybold Clinic in Houston was awarded contract to conduct physical examination in Air Force Ranch Hand Study. Jan 1982 Physical examination began for Air Force Ranch Hand Study. Revised protocol for epidemiological study submitted, to VA by UCLA. Feb 1982 Expiration of comment period for guidelines (Circular 10-81-249) published in the Federal Register. Initiation of effort by Office of Environmental Medicine to revise circular in light of consumer recommendations. -10827004-f �Feb 1982 Agent Orange Research and Education Office established, in Office of Deputy Administrator, to serve as a focal point for all VA Agent Orange matters. March 1982 Agent Orange Working Group's Science Panel, Office of Technology Assessment, and VA Advisory Committee on Health-Related Effects of Herbicides completed review of second submission of epidemiologf.cal study draft protocol. Comments provided to UCLA. First of "several Agent Orange pamphlets published by Office of Public and Consumer Affairs. April 1982 Third and final draft epidemiological study submission received from UCLA. May 1982 Epidemiological Study submission provided to Agent Orange Working Group and Office of Technology Assessment for review. VA Advisory Committee reviewed and discussed document in closed session. Contract signed with National Academy of Sciences for review of protocol. Deputy Administrator letter sent to all participants of VA Agent Orange registry enclosing recently published pamphlets. June 1982 June-Sept 1982 Aug 1982 Administrator approved first comprehensive Agent Orange budget. Discussions and correspondence among Federal agencies attempted to define epidemiological study cohorts. Circular 10-82-154 issued to provide for update of names and address in VA Agent Orange registry. �Sept 1982 Congressional Hearing. Subcommittee on Oversight and Investigations of Rouse Committee on Veterans* Affairs held a hearing on the Federal Agent Orange activities. Correspondence began between VA t HRS concerning possibility of transfer of epidemiological study. OTA complained that future progress on epidemiological study could not be made without decisions on basic design of the study. Letter from leadership of House Veterans' Affairs Committee recommends that VA contract with Centers for Disease Control (CDC) to conduct epidemiological study. Chloracne Task Force reestablished with Dr. A. Betty Fischmann, Chief, Dermatology Service, VAMC Washington, D.C., as chairperson. Final guidelines issued implementing Agent Orange medical care provisions of Public Law 97-72. Oct 1982 Third International Symposium on Chlorinated Dioxins and Related Compounds held in Salzburg, Austria. VA participated. General Accounting Office report issued on VA Agent Orange Examination Program. 100 members of Congress signed letter urging transfer of epidemiology study to CDC. RHS and VA agreed in principle that study should be transferred. National Academy of Sciences provided comments on proposed protocol. Kov 1982 Total number of initial Agent Orange registry examinations exceeded 100,000. Air Force Health Study (of Ranch Rand personnel) interim report issued. -/A �Nov 1982 Establishment of DM&S Agent Orange Projects Office announced. First issue of Agent Orange Review, a periodical with updated information concerning the VA Agent Orange program, sent to all VA field installations. Jan 1983 Interagency agreement betwen VA &nd HHS signed transferring epidemiology study to CDC. �EPIDEMIOLOGICAL STUDY - CHRONOLOGY December 1979 - Congress passes the "Veterans Health Programs Extension and Improvement Act of 1979." PL 96-151, Section 307 of the Act directs the Administrator to design a protocol for and conduct an epidemiological study of Vietnam veterans who were exposed to dioxins contained in herbicides (Agent Orange). December 20, 1979 - President signs the Act into law. January 8, 1980 - Decision made to use the competitive procurement method to obtain the required services for the design of the protocol. January 10, 1980 - President directs the Administrator to forward protocol to Director, Office of Technology Assessment (OTA) for information purposes only. February 4, 1980 - Announcement of intent to let contract for the design of the protocol published in Commerce Business Daily. February 6, 1980 - Administrator advises OTA of President's directive and offers to cooperate to the extent that the Constitution permits. February 21, 1980 - Chairman, Senate Veterans Affairs Committee, advised by Administrator of President's directive and assures him that VA would not proceed with a protocol to which OTA had serious objection. March 19, 1980 April 11, 1980 Request for proposals issued. - Pre-bid conference conducted by VA at VACO. S-t �May 6, J980 - National Veterans Law Center initiates legal action attempting to obtain a temporary restraining order to preclude VA from opening any proposals received for the contract for the design of the study* May 1, 1980 - Court denies motion for temporary restraining order but retains jurisdiction. May 8, 1980 - Last dt.y for receipt of bids. May 1980 - A selection panel of government epidemiologists (including one from OTA) reviews bids received and makes tentative ranking. On advice of U.S. attorney no further action is taken because of litigation and pending referral of bid protest to GAO. June 13, 1980 At the request of the National Veterans Law Center, Judge Green refers matter to GAO to rule on bid protest. June 1980 - VA General Counsel, with concurrence of Department of Justice, advises against award of contract prior to resolution of pre-award protest. February 2, 1981 - GAO rules entirely in favor of VA. February/March 1981 - VA contacts bidders and allows updating of submission if still interested in and capable of designing study protocol. April 1981 - Panel of experts reconvened to review revised bids. May lr 1981 - School of Public Health, U.C.L.A., selected to design study protocol. May 1, 1981 - U.C.L.A. receives notice of award, (contracted for $114,288). Has 60 days to submit draft of study protocol. June 1981 - U.C.L.A. granted 30 day extension for submission due to difficulty experienced in working with DoD records. �August 6, 1981 «•• Preliminary design submitted by U.C.L.A. August 1981 VA submits design to Agent Orange Working Group, VA's Advisory Committee and OTA for review and comment. October 8, 1981 Response received from OTA and provided to U.C.L.A. October 21, 1981 Response from Science Panel, Agent Orange Working Group received. November 3, 1981 PL 97-72 signed, allowing Administrator to expand study to include other factors in Vietnam experience* November 6, 1981 Response received from VA's Advisory Committee. November 9, 1981 Responses from review groups sent to UCLA. November 18, 1981 Senate Committee on Veterans Affairs hearing on Agent Orange. November 25, 1981 VA notified UCLA that submission, as received and reviewed, was inadequate and allowed UCLA 35 days to resubmit. December 14, 1981 UCLA requested additional 35 days (to January 25, 1982) because of Principal Investigator's illness. January 22, 1982 Revised protocol for epidemiological study submitted to VA by UCLA with recommendation for two cohort effort. February 1982 Revised protocol provided to Agent Orange Working Group (AOWG), VA's Advisory Committee, and OTA. S-3 �March 2J, 1982 - AOWG completed review of protocol and endorsed the design with certain recommendations. March - OTA completed review with findings similar to those of the AOWG. VA's Advisory Committee members submit views. Comments sent to UCLA. 1982 April 29, 1982 - Third and final protocol submission received from UCLA. 1982 - Revised protocol provided to Agent Ofange Working Group and OTA. May 13, 1982 - During special closed session, VA's Advisory Committee reviewed third submission. May 20, 1982 - Contract signed with National Academy of Sciences (NAS) for review of proposed protocol. June 10, 1982 - VA requested AOWG views on a number of issues, including selection and use of cohorts. July 2, 1982 - Letter from DoD to AOWG argued for three cohort study. July 6-8, 1982 - NAS review began. July 15, 1982 - Science Panel of AOWG discussed cohort selection and established subcommittee to recommend how cohorts should be identified. August 23, 1982 - NAS requests extension of time until October 31 to complete review of protocol. September 3, 1982 - Cohort selection sub-committee sent status report to AOWG suggesting method of cohort identification to be tried in pilot test. September 7, 1982 - VA requests additional justification from NAS to substantiate time extension. May �September 15, 1982 Subcommittee on Oversight and Investigations of House Committee on Veterans' Affairs held hearings on Federal Agent Orange activities. Witness from Centers for Disease Control (CDC) suggested that CDC could have designed and initiated the study more expeditiously than VA. September 27, 1982 Letter fron Congressman G.V. (Sonny) Montgomery (Chairman, House Committee on Veterans' Affairs), John Paul Hammerschmidt (Ranking Minority Member, House Committee on Veterans' Affairs and Ranking Minority Member, Subcommittee on Hospitals and Health Care), and Ronald M. Mohl (Chairman, Subcommittee on Hospitals and Health Care) recommended that VA contract with CDC to "conduct all phases of the Agent Orange Study." September 30, 1982 Letter from Administrator to Secretary of Health and Human Services (HHS) concerning possibility of transfer of study to CDC. Letter from Office of Technology Assessment concerning progress on the study and the need to make decisions about the basic design of the study. October 6 r 1982 Letter from Congressman Tom Daschle and 99 other members of Congress proposed that CDC "assume responsibility over the remaining segments" of the study. October 14, 1982 Letter from Administrator to Secretary of HHS requesting information on CDC's interest in performing the study. Letter from Administrator to Chairman Montgomery stating "that it would be prudent to enter into an agreement with a non-VA scientific body" to perform study. Letter noted contact with HHS in effort to transfer study to CDC. �October 22, 1982 Letter from Secretary of HHS to Administrator acknowledging letters of September 30 and October 14. He agrees in principle to the transfer of the study to CDC provided adequate resources are made available and requests that copies of all pertinent documents be forwarded to CDC. Meeting between Chief Medical Director, VA, and Assistant Secretary for Health, Human Services (HHS). Agreement in principle to transfer study to CDC. October 28, 1982 NAS comments on proposed protocol received by VA. November 23, 1982 VA draft of interagency agency agreement submitted to CDC for review and comment. November 31, 1982 Chief Medical Director (CMD) discussed transfer of study at open meeting of VA Advisory Committee on Health-Related Effects of Herbicides. CMD indicated desire for expeditious finalization of interagency agreement. December 6, 1982 Letter from Assistant Secretary for Health, HHS, concerning transfer of study enclosed CDC's version of proposed interagency agreement and CDC's proposed protocol outline and tentative timetable for conduct of the study. December 23, 1982 Letter from CDC outlining requirements for conduct of epidemiology study �January 13, 19-83 Letter from CMD to Dr. Brandt, Assistant Secretary for Health, DHHS, transmitting interagency agreement signed by VA for review and signature by CDC. January 14, 1983 Interagency agreement between VA and HHS signed transferring epidemiology study to CDC, February 2, 1983 OTA receives copy of CDC's proposed study protocol, Copies forwarded to members of OTA Agent Orange Advisory Panel. March 3, 19.83 Letter from John Gibbons, OTA, to Administrator commenting on CDC's "Outline" (protocol). Advised in letter that CDC expects to complete drafting of protocol into April or early May. Protocol outline and tentative timetable for study transmitted by letter. March 4, 1983 Letter from Assistant Secretary for Health, DHHS, to CMD briefly outlining CDC's PY 1983 resource requirements and suggested PTEE requirements for FY 1984. Request made by DHHS that VA take expeditious action to obtain OMB approval for transfer of resources. Draft letter from DHHS to OMB outlining resource justification provided to CMD. March 11, 1983 Meeting at VACO between Dr. David Erickson, CDC, Agent Orange Projects Staff, Comptroller's Office and Supply Service to discuss CDC's justification package for 28 FTEE requested by CDC in FY 1983. Participants advised by Dr. Barclay M. Shepard that a stronger justification is required. A conference call at this time with Annette Rooney, OMBf resulted in CDC agreement to prepare a stronger justification package and to participate in a March 18 meeting at OMB on CDC's request for FTEE. Dr. Barclay M. Shepard advised by Mr, Claude Picklesheimer, Finance Office, CDC, that CDC was under impression that $3 million was FY 83/84 money. Advised by Dr. Shepard that resources would be lost at close of fiscal year. Dr, Shepard urged that CDC request funds as soon as staff are on board for study and funds can be obligated. S-7 �March 15, 1983 Administrator directs DM&S to continue to provide all necessary support and to expedite the transfer of resources to CDC in order to assist CDC in initiating the epidemiology study in the immediate future. Contact made with Dr. David Erickson, CDC, requesting CTX3 participation in March 18 meeting at OMB to justify to OMB the resources requested by CDC. March 17, 1983 Letter transmitted from Assistant Deputy Administrator, Budget and Finance to OMB forwarding proposed study outline and request for personnel resources as submitted to VA by CDC. March 18, 1983 Meeting between VA/CDC/OMB at OMB on justification of resources requested by CDC. March 25, 1983 Letter from Administrator to Sam Clarkson, OMB, requesting 28 positions (14.0 FTEE) and notification that CDC is to provide VA with complete budget estimates and justification for FY 84 and beyond. April 15, 1983 Meeting with OMB representative and VA staff on need to request further justification for CDC's FY 1984 budget requirements. �L. Department of Medicine and Surgery Washington D.C. 20420 Veterans Administration JAN 1 3 1983 In Reply Refer To: 1 OA7 Edward N. Brandt, Jr., M.D. Assistant Secretary for Health Department of Health and Human Services Washington, D.C. 20201 Dear Dr. Brandt: Enclosed is the proposed Interagency Agreement to effect the transfer of the epidemiological study from the VA to the CDC. The present language of the agreement is the culmination of a number of previous efforts and informal contacts between staff members of our respective offices. In the interest of expediting the completion of protocol development and implementation of the study, I am hopeful that you will find the language of the agreement satisfactory and suitable for signing within the next few days. The VA is prepared at this time to make an advanced payment to CDC of the $3,000,000 identified in the VA's FY 1983 budget for initiation of the study. In addition, we will work with you in obtaining OMB clearance for providing to CDC the requisite 28 FTEE for this fiscal year. In your letter of December 23,1982, you propose that resource requirements beyond the $3,000,000 and 28 FTEE be included as a multi-year- appropriation in FY 1984. We will be pleased to join you in exploring the feasibility of this suggestion with OMB and the appropriate Congressional committees. On the matter of the periodic mortality follow-up effort, I believe this should be included in the CDC study, and as such be made a part of the budget proposal in support of the full study. I have reviewed with interest the outline for the conduct of the study as proposed by CDC. The concept of two concurrent studies, one to examine the effects of exposure to Agent Orange and the other the impact of the Vietnam experience has �2. Dr. Edward N. Brandt considerable merit and provides the advantages of two complimentary efforts. I do have great concern, however, over the suggestion that the VA conduct the physical examinations and laboratory studies for the 4,000 veterans, in each of the five cohorts, who will not be examined by CDC as part of the study. If two-thirds of the individuals answering the questionnaire are to be examined in VA medical centers, I believe that it would be very difficult to convince the majority of Vietnam veterans that the VA is not actually involved in the conduct of the study. I therefore have taken the position that if it is the recommendation of CDC that all study subjects receive a physical examination and laboratory work-up, CDC should include this as part of the budget proposal and justification for OMB and Congressional action. I hope that we have reached sufficient consensus on these issues so that we can now finalize the interagency agreement. Sincerely, DONALD L. CUSTIS, M.D. Chief Medical Director Enclosure �N 11 1983 IGA V101(91)P-83002 INTERAGENCY AGREEMENT BETWEEN VETERANS ADMINISTRATION AND CENTERS FOR DISEASE CONTROL PUBLIC HEALTH SERVICE Background. Public Law 96-151, Section 307, mandates that the Veterans Administration (VA) design a protocol and conduct an epidemiological study to determine if veterans of the Vietnam conflict suffer long-term adverse health effects from exposure to dioxins produced in the manufacture of phenoxy herbicides including Agent Orange. Public Law 97-72 permitted the expansion of the protocol design and study to include an evaluation of any long-term adverse health effects in humans which may result from other factors involved in service in Vietnam including exposure to other herbicides, chemicals, medications, or environmental hazards or conditions. Members of Congress recently urged that the VA "contract with the Centers for Disease Control (CDC), Atlanta, Georgia, to conduct all phases of the Agent Orange Study." As a result of subseguent meetings and correspondence between VA and CDC, an agreement in principle has been reached for the transfer of the study from VA to CDC. The details relating to the respective responsibilities of the two agencies are outlined below. XI. Purose This Interagency Agreement is for the purpose of transferring from the VA to the CDC the resources and authority for the design, implementation, analysis, and scientific interpretation of a valid epidemiological study in accordance with Section 307 of Public Law 96-151, as amended. - 1- 6-3 �III. VA Responsibilities. A. ~?9r the purpose of assisting CDC in developing its recommended study design, the VA has provided CDC with a preliminary study design developed by the School of Public Health, University of California at Los Angeles, along with extensive reviews from the Science Panel, Agent Orange Working Group; the Office of Technology Assessment* the VA Advisory Committee on the Health Related Effects of Herbicides; and the National Academy of Sciences, National Research Council. Also provided were: certain suggested modifications of the study design (insofar as these have been developed), a statistical consultant's report on the study design, and a draft statement of work for inclusion in a Request for Proposal for the conduct of a pilot phase of the study. Upon request from CDC, the VA will provide other documents in its possession as are necessary for the further design and conduct of the study. B. The VA will submit to the Office of Management and Budget (OMB) and the appropriate committees of Congress specific requests for fiscal and personnel resources to support the conduct of the study. In so doing, the VA will depend on information and justification provided by CDC as outlined in Sections IV.H. and VI.C. of this agreement. C. The VA will forward the final report of the findings of the study to the Congress as it is received in finished form from CDC. D. The VA will submit to OMB the CDC's information collection budget proposal for approval under the Paperwork Reduction Act. Accordingly, any information collection hours associated with the study will be assigned to the VA's information collection budget for use by CDC in the conduct of the epidemiological study. E. The VA will provide a point of contact to act as liaison with the CDC project officer as noted in Section IV.I. of this agreement. The VA's point of contact is: Title: Address: Director, Agent Orange Projects Office (10A7) Room 848, VA Central Office 810 Vermont Avenue Washington, D.C. 20420 Telephone: FTS 389-5411; Commercial (202) 389-5411 - 2- �IV. CDC Responsibilities. A. The CDC will complete the epidemiological study as expe-ditiously as possible, but not later than September 30, 1987.* B. All decisions related to the desiqn, conduct, analysis, and scientific interpretation of the results of the study, as well as analysis of the data obtained during the course of the study, shall be the sole responsibility of the CDC. The CDC will submit the study protocol to the office of Technology Assessment for its review and comments. Reports of results of the study will be authored by the CDC. C. To the extent permitted by law, the CDC agrees to maintain the confidentiality of any documents provided by the VA as outlined in Section III.A. of this agreement and designated by the VA as confidential. Also to the extent permitted by law, the CDC agrees that all documents provided by the VA to the CDC pursuant to this agreement, whether designated by the VA as confidential or not, shall be used solely for the purpose of the study and for no other purpose unless mutually agreed upon by VA and CDC. D. The CDC will prepare the necessary information collection budget proposal for OMB approval under the Paperwork Reduction Act. This proposal will be submitted by the CDC to the VA for formal submission by the VA to OMB. E. The CDC will furnish reports of information necessary for the VA to comply with the Report to Congress required by Public Law 96-151, Section 307(b)(2), as amended by Public Law 97-72, Section 401(b)(1). F. Findings resulting from the epidemiological study and an evaluation of those findings will be incorporated into a final report from CDC to VA as expeditiously as possible. G. The CDC agrees to provide quarterly progress reports to the VA. H. The CDC will, at the VA's request, assist the VA in providing testimony at any and all congressional hearings, including appropriation hearings, regarding the epidemiological study until such time as the study is complete. I. The CDC project officer is: Name: Title: Address: Dr. J. David Erickson Epidemiologist, Center for Environmental Health Centers for Disease Control Atlanta, Georgia 30333 Telephone: FTS 236-4035* Commercial (404) 452-4035 �V. Authority. i A. The CDC has legislative authority under Section 301(a) of the Public Health Service Act to conduct research into the health effects of a broad range of environmental hazards and to cooperate with other appropriate authorities in the conduct of such research. B. As previously indicated, the VA has authority under Section 307 of Public Law 96-151 to design and conduct an epidemiological study relating to exposure to Agent Orange and to expand the scope of the study as provided in Public Law 97-72. C. The VA has authqrity to enter into this agreement under the Economy Act, as amended (31 U.S.C. Section 1535) and 38 U.S.C. Section 213. VI. Resources. A. The VA will initiate appropriate action to obtain OMB approval of the CDC request for 28 full-time equivalent employment (FTEE) for FY 1983. B. Upon request from the CDC for advance payment, the VA will pay CDC up to $3,000,000 for qoods and services required under this agreement during FY 1983. Subsequent fiscal year funding requests may also be paid in advance as agreed to by the VA from time to time. Any amount paid in advance is subject to adjustment for actual costs incurred, as required in 31 U.S.C., Section 1535 (1982). C. The CDC will identify and fully justify all fiscal and FTEE requirements for use by the VA in submitting specific funding requests to OMB and Congress for the conduct of the study in FY 1984 and beyond. These requirements will be submitted in a timely and appropriate manner so as to be included and specifically identified in the VA's budget and planning efforts. Only those resources specifically approved by OMB and appropriated by Congress for the conduct of the study will be made available to CDC by the VA for this purpose. D. CDC agrees to utilize the resources provided by the VA solely for purposes that CDC deems to be related to the epidemiological study. CDC will provide VA with a quarterly statement of the costs incurred in the performance of this agreement. The cost statement shall be made in conformance with standard government budget and accounting requirements. - 4- �VII. Amendments. This agreement or any of its specific provisions may be revised by signature approval of both the parties signatory hereto, or their respective successors. VIII. Effective Date. This agreement is effective as of October 16, 1982, and shall continue in effect unless modified in writing by mutual agreement. IX. Termination. A. The period of this agreement is through September 30, 1984, to be renewed annually thereafter for the duration of the study. 8. In the event that the necessary fiscal and personnel resources are not provided to the CDC as specified in Section VI.A., B., and C. of this agreement, the CDC will be under no obligation to undertake or complete this epidemiolocrical study. C. In the event that OMB fails to approve the necessary information collection budget hours in accordance with the Paperwork Reduction Act of 1980, the CDC will be under no obligation to undertake this epidemiological study. VETERANS ADMINISTRATION U. S. PUBLIC HEALTH SERVICE DEPARTMENT OP HEALTH AND HUMAN SERVICES Title_Chief Medical Director Title Assistant Secretary for Health Date Date •" - 5- ^ ' �DELEGATION OF AUTHORITY The Chief Medical Director is hereby delegated the authority to enter into an agreement with the United States Public Health Service, Department of Health and Human Services, for the transfer of the responsibility for the design, implementation, analysis and interpretation of the epidemiological study mandated by Pub. L. No. 96-151, as amended by Pub. L. No. 97-72. Any modification, revision, or termination of this agreement may be accomplished only with the concurrence of the Administrator of Veterans Affairs. HARRY N. WALTERS Administrator Date: �DEPARTMENT OF HEALTH * HUMAN SERVICES , fubfe Hwtth Svrvk* OffiM of the Awiflt«nt Socrotary f0f HMiitn Washington DC 20201 DEC 6 1982 Donald Oustis, M.D. ( 0 1) Chief Medical Director Veterans Administration BIO Vermont Avenue, N.W. Washington, D.C. 20420 Dear Dr. Oustis: Enclosed is the Centers for Disease Control (CDC) protocol outline for epidemiologic studies related to the possible health effects of unitary service in Vietnam and exposure to Agent Orange. Two separate but parallel historical cohort studies are proposed. The first will conpare three cohorts of Vietnam veterans which will differ in their presumed levels of exposure to Agent Orange. The second will conpare a cohort of Vietnam veterans with a cohort of Vietnam-era veterans who did not serve in Vietnam ("Vietnam Experience" study). This protocol outline is the result of intensive work during the past several weeks by a committee of CDC scientists. The outline requires substantial effort to bring it to a full and complete protocol. This effort will require the assembly of a sizeable CDC team, extensive use of consultants, intensive scrutiny and review by non-Federal scientists, and comment by veterans groups. Before proceeding with this considerable effort, a formal interagency agreement must be reached in the near future between the Veterans Administration (VA) and CDC for transfer of a total of $3 million and 28 full-time equivalent (FTE) positions for Fiscal Year 1 8 . For Fiscal Year 93 1984, in addition to monies, an additional 22 FTE's will be required, bringing the total FTE's to 50 for the duration of the study. Also enclosed is a revised copy of proposed interagency agreement which we need to finalize as quickly as possible so that further development of the protocol can proceed. We also need for the VA to agree to transfer further fiscal resources to CDC to support the conduct of the study. Depending on the details of the final study design, which will emerge only after the vigorous debate which no doubt will take place during protocol development, up to a maximum of 50 FTE's annually and a total of $150 million may be required (a detailed budget is being prepared). The FTE's and any unexpended funds would revert to the VA upon completion of the studies. We also need agreement that the VA will provide the required number of information collection budget hours. Without these commitments from the VA, CDC cannot accept responsibility for designing and conducting the requisite studies. �Page 2 - Donald Cost is, M.D. ( 0 1) Our estimated costs for the design and conduct of these studies range between" $70 and $150 million. This wide range derives from 2 factors. First, the protocol outline calls for each cohort to comprise 6,000 veterans. It is proposed that each of the 6,000 veterans be included In a mortality study and Invited to complete a health/exposure questionnaire. It is further proposed that (at most) 2,000 from each cohort be given a physical examination and laboratory workup. The exact specifications for the physical examination and laboratory analyses can only be determined during the process of full protocol development. Thus, we have taken the approach of estimating examination and laboratory costs by assuming very comprehensive workups like those being done in the Air Force's Ranch Hand study. Further, the CDC committee which drew up the protocol outline believes that it Is possible that the final protocol ^nlflht call for fewer than 2,000 examination/laboratory participants per '"o.tttrt. However, since this cannot be decided without considerable further affort, we have based our estimated lowest costs on 2,000 per cohort. The second major factor which has led us to present a broad range of possible costs involves an uncertainty about what expectations study participants might have concerning the examination/laboratory phase. Whatever scientific decision is reached about the numbers required for this phase, veterans who participate in the questionnaire phase may expect to receive an examination and laboratory analysis. Some mechanism may need to be developed whereby those who participate in the questionnaire phase, but who are not chosen for the examination phase, can have a thorough and sympathetic (nonstudy) examination done at no cost, if desired. The highest of our budget projections, therefore, reflects payment for comprehensive (Ranch Hand-like) examinations for 6,000 men per cohort. These costs would be markedly reduced if the VA decided to provide in its facilities the physical examinations and laboratory test for the remaining 4,000 men per cohort. I would like you to know the background which formed the basis of our recommendation for conducting the Agent Orange and Vietnam Experience studies concurrently. First, it is possible that Vietnam veterans do suffer poorer health than their counterparts who did not serve in Vietnam; however, such poor health could be due to a variety of causes other than Agent Orange exposure. An Agent Orange study alone will not test other causative factors. If the Agent Orange study alone is done and no health differences are found between exposed and nonexposed veterans, it would be reasonable for Vietnam veterans to ask if their self-perceived poorer health is due to causes other than Agent Orange. Also, once protocol development is complete, an Agent Orange study will take about 4 1/2 years to produce results. If a Vietnam Experience study is found necessary after the completion of the Agent Orange study, an additional 5 or more years will be required for new protocol development and data collection and analysis. Thus, beginning both 7-2, �Page 3 - Donald Custis, M.O. (10) studies fn parallel will avoid unnecessary delays in providing information which veterans anxiously await. Moreover, the total costs will be less if the studies are done in tandem, because there will be less duplication of effort and because of economies of scale. Second, the development of criteria defining exposure and nonexposure to Agent Orange will be difficult. Even though considerable thought has been given to this issue over the past 3 years by several groups, no general consensus has emerged. Obtaining a consensus on the acceptability and validity of exposure criteria from all interested parties (including veterans groups, as suggested by the National Academy of Sciences review panel) will be time-consuming, and indeed may not be possible. As you know, it was uncertainty about the definitir :> nf Agent Orange exposure in Vietnam which led to the passage of the section o. ft. 97-72 which permitted the expansion of the mandated Agent Orange study (PL 96-151) to include an assessment of the Vietnam experience. Public and congressional expectations are that a scientifically sound study can be done and that this study will be done quickly. Limiting attention only to an Agent Orange study may prove to be shortsighted. Concurrent development and early implementation of a Vietnam Experience study will provide the best opportunity to be responsive to public and congressional expectations and to assure that a feasible and scientifically sound health effects study will be conducted even if consensus cannot be reached regarding Agent Orange exposure. Two other issues merit discussion. First, in addition to ongoing and proposed Federal research activities, there may be other opportunities for clarifying Vietnam-related health issues. A concerted effort should be made to explore ways in which currently available data can be used. For example, the VA's Patient Treatment File might provide a mechanism for investigating the health of Vietnam veterans. CDC is available to consult with the VA on ways in which these and other data might be used, but CDC is not seeking an active role in such studies. The second issue is the suggestion in CDC's protocol outline that the study cohorts 1should be assessed for mortality every 5 years for the "foreseeable future.* This extended followup has not been included in CDC's budget estimate, since it is not clear which agency would have responsibility. In summary, we propose: (1) That a Vietnam Experience study, as well as an Agent Orange study, be conducted; (2) That the VA commit to provide to CDC the necessary positions and funds, up to 50 FTE's annually and a cumulative total up to $150 million; and 7-3 �Page 4 - Donald Custis, M.O. (10) (3) That the VA approve the enclosed interagency agreement to provide immediately $3 million and 28 FTE's to COC so that protocol development may proceed expeditiously. I look forward to your review and early response to these proposals. Sincerely yours, Edward N. Brandt, Or., M.D. Assistant Secretary for Health Enclosures �Protocol Outline Tentative Timetable Epldemiologlcal Studies of the Health of Vietnam-Era Veterans (Agent Orange) Overall Design The Centers for Disease Control (CDC) recommends two complementary historical or retrospective cohort studies. One study will compare the health of a group of U.S. veterans of the Vietnam conflict with the health of a group of Vietnam-era veterans who did not serve in Vietnam; it may include individuals from all four branches of the military. The purpose of this study will be to make an assessment of the possible health effects of the general Vietnam service experience. The other study, which is designed to evaluate the health effects of possible exposure to herbicide Agent Orange, will compare the health of three groups or cohorts of Vietnam veterans who differ in their probable level of exposure to Agent Orange. This second study will focus primarily on veterans of the. Army but will probably include veterans of the Marine Corps. Each of these two studies will have three major components: D a mortality assessment (mortality followup will be repeated every 5 years for the foreseeable future); 2) a health and exposure questionnaire; and 3) a clinical and laboratory assessment. The studies will have several other features in common. However, the sampling plans and some of the health outcomes measured in the questionnaire and clinical assessments will differ between the two studies. Moreover, they will follow different timetables. They are designed to answer related but distinct questions of importance to Vietnam veterans and their families. These two studies should be sufficient to meet the directive of Congress which instructed the Veterans Administration to conduct an "epidemiological study"; in addition, they are responsive to current veterans' and congressional concern. However, these studies are but a part of the Federal effort to provide answers about the possible health effects of herbicides and their contaminants, and about the effects of military service in Vietnam. Other major Federal activities include: 1) COC's ongoing study which is designed to determine if Vietnam veterans are at increased risk of fathering babies with birth defects; 2) CDC's N10SH Dioxln Registry, which will assess the health effects of occupational exposure to dioxin during the manufacture of herbicides and related chemicals; 3) the U.S. Air Force's comprehensive health study of veterans who applied herbicides in Vietnam from fixed-wing aircraft ("Ranch Hand" study); A) the Veterans Administration's (VA) proportionate mortality study of Vietnam veterans; the VA is also supporting protocol development for a study of twins, one of whom went to Vietnam and one of whom did not. Composition of Cohorts and Sampling Plans The choice of individuals for inclusion in the various study cohorts will derive from review of military records from the Vietnam era. Considerable �thought about and work with records from Vietnam has been done by the Department of Defense (primarily staff of the Army Agent Orange Task Force-AAOTF), the Veterans Administration, and the White House Agent Orange Working Group. A consensus seems to have been reached that the choice of individual veterans for an Agent Orange study will involve the use of personnel records and company level action records and a variety of herbicide usage records. More thought needs to given to the specific organization and analyses of records which might be used for a Vietnam Experience study, but it is recommended that company level records also be used for this study. a) Agent Orange Study A good design for a historical cohort study of the possible health effects of Agent Orange would involve the use of 2 groups of men who were as similar as.possible in all respects except for their exposure to the herbicide. One group would ideally be free from all exposure while the others would have been subjected to "meaningful" exposure. (Other attractive designs might include subdivisions of those exposed based on levels and/or duration of exposure, or even continuous measures of exposure for individual veterans.) It appears that such an ideal is not attainable. Obstacles include: 1) the military records which must be used were made during a war and, therefore, of uneven quality; 2) an inability to define objectively "meaningful" exposure; 3) the difficulty in ensuring that veterans who were possibly or likely exposed (by whatever measure) are comparable (with respect to all things which might influence health) to veterans who were not exposed. Under ordinary circumstances, such obstacles would probably prevent the initiation of an Agent Orange study. It is, therefore, mandatory that advance advice and consent be obtained from veterans' groups with respect to study policies and procedures, especially those directed at defining Agent Orange exposure. The important company records which give information about troops are the morning reports and the Journal files. The morning reports can be used to document the presence or absence of individual servicemen on a daily basis while the daily journal files will indicate the locations of companies in time and space. The major herbicide records are those which document the time and location of fixed-wing aircraft applications of herbicide (Ranch Hand missions—contained on the "Herbs" tape), base perimeter applications records, and information about Ranch Hand mission aborts (dumps). The choice of an Individual for inclusion in the "likely-exposed" cohort will be based on a measure of company proximity in time and space to herbicide applications as documented by these records. Members of the "non-exposed" cohort will likewise be chosen because of a measure of their company's distance in time and space from any herbicide applications. �The company records may contain gaps (i.e., whole periods of time missing) and are probably quite variable in terms of quality and detail, because they were created during the war. The herbicide usage records are known to contain errors with respect to the time and location of applications and the degree of their completeness is unknown. They are far from ideal as the starting point for an historical cohort study. There may be opportunities to assess the accuracy and completeness of the herbicide usage records, and every effort will be made to pursue these opportunities. However, there are no possiblities for similar checking of the company troop records. Thus, the categorization of Individuals with respect to their potential for herbicide exposure will be uncertain and will forever remain so. The desire to ensure that troops classified as "exposed" to Agent Orange are comparable to "non-exposed" troops with respect to other factors which might influence health is another issue which makes it difficult to design an "ideal" study. The underlying problem is that the use of herbicide was not equally distributed in Vietnam. Areas where it was heavily used were generally combat areas and differed in terrain and flora from those areas where it was little used. These areas may also have differed in other important respects, such as, indigenous diseases, level of combat intensity, and type of personnel deployed. It is for these reasons that much of the recent thinking about the subdivision of troops into "exposed" and "non-exposed" groups has been directed at choosing the cohorts from the same area of Vietnam. Unfortunately, because of the inherent limitations of the records, this approach may have the effect of increasing exposure misclassification (especially the categorization of those who are truly "exposed" into the "non-exposed" group). These two competing forces, the desires for comparability and for maximum exposure separation, have drawn CDC to recommend a three-cohort design. Two of the three cohorts will be from the same area of Vietnam (and time during the war) but will differ in regard to their exposure likelihood. These two cohorts will be comparable but suffer from imprecision of exposure separation. The third cohort will be drawn from another area of Vietnam (but from the same time period), an area where there is good evidence of little or no herbicide usage. This cohort will give maximum exposure separation from the "exposed" cohort but may suffer from a lack of comparability in respect of other health-influencing factors. This design is incomplete, as is Illustrated in the following 2 x 2 table which cross-classifies exposure by a measure of general experience, which will be called "combat." Agent Orange Exposure Yes No Yes Cohort 1 Cohort 2 "Combat" No Cohort 3 7-7 �The empty cell, representing the combination of Agent Orange exposure with no "combat," cannot be filled, because it is our understanding from the military that Agent Orange use was Inextricably entwined with a certain "combat" experience. Because of its incompleteness, this design will present problems in analysis and interpretation. Moreover, the comparison of the first and third cohorts, which will ensure maximum exposure separation, may be subject to respondent bias; respondent bias should not be a problem in a comparison of cohorts 1 and 2, because individual respondents will probably be uncertain about their (study) exposure status. Despite these problems, we believe that this design is better than either of the other alternatives based on an approach which uses only two cohorts--either decreasing exposure mlsclassification by decreasing comparability or increasing exposure mlsclassification by increasing comparability. The results of the Ranch Hand study, currently being conducted by the U.S. Air Force, may help in the interpretation of this incomplete design. The Ranch Hand study will compare the health of crews who flew the herbicide spray missions with air crews who did not fly spray missions. Thus, it will provide information about Agent Orange exposure in the absence of the general experience of ground troops. b) Vietnam Experience Study The idea of studying ill-health effects which might derive from the "general experience" of having been in Vietnam is at once attractive and unappealing. It is attractive because there may have been many factors which could have adversely affected those who served in Vietnam, in contrast to their counterparts who served elsewhere. And it is also plausible that Vietnam veterans who did not see active combat in Vietnam were subjected to health-influencing events that were not part of the experience of those who served elsewhere. Any ' study which focuses on Agent Orange alone will obviously not test such a plausible multifactorial hypothesis. However, the multifactorial nature of this hypothesis makes the study of the "Vietnam experience" unappealing from the scientific point of view. The "experience" comprises many factors, many of which are unknown, poorly defined, or not quantifiable. Nevertheless, it is our opinion that this is an important question to the Vietnam veteran, and one which deserves as much attention as the issue of the possible effects of Agent Orange. Viewed In the broadest terms, the Vietnam "experience" could have influenced anyone who served there. It is, therefore, suggested that consideration be given to the inclusion of veterans of the Army, Navy, Marines, and, if possible, the Air Force (the records systems of the Air Force might make inclusion of that service's veterans very difficult). �A major concern about the validity of making a comparison of Vietnam and non-Vietnam veterans derives from an undocumented suspicion that there may have been preexisting differences between the two groups in terms of health-influencing factors and behaviors. If such differences existed and if they applied to all veterans, then a valid study of the Vietnam "experience" would not be possible. However, military personnel with whom we have consulted do not feel that such factors would have existed for all Vietnam veterans. Specifically, it is their belief that being sent to Vietnam was a matter of the "luck of the draw" for those who wore drafted or who were short-term enlistees. Serving in Vietnam, the U.S., in Europe, or elsewhere was, in their opinion; a matter which depended on occupational specialty and the opsrational needs of the various commands. Thus, any given serviceman was at risk of serving anywhere where there was a need for his occupational specialty. Choice of individuals for the two cohorts of this study should be made after a review of company and personnel files in much the same manner as will be done for the Agent Orange study. A simple random sample or a stratified random sample of Vietnam veterans and non-Vietnam veterans would probably be the method of choice but the filing of the available records probably makes this infeasible. Therefore, we recommend a cluster sampling of military units (much as will be done for the Agent Orange study) and a random sampling within clusters as the method for selecting members of each cohort. Sample Sizes It is recommended that each of the 5 cohorts (3 Agent Orange study and 2 Vietnam Experience) be composed of 6,000 servicemen. All of these individuals will be included in the mortality studies, and it is hoped that up to 90% of the surviving cohort members will be included in the questionnaire phase of the studies. (The results of the Ranch Hand study, better than 95% interview completion, give reason to set such an optimistic goal. If, however, the questionnaire pilot studies give indications of completion rates much under 70 or 75%, careful consideration should be given to not proceeding with the main studies.) The number of 6,000 for each cohort was chosen because comparisons between 2 groups of between 5,000 and 6,000 each will be able to detect (alpha = beta • 0.05, 1-tail) 2-fold increases in the relative risk for health outcomes which ordinarily occur at the rate of 0.5X, for example, all cancers (detecting associations for specific cancers would require truly massive cohorts—this problem is probably best approached through specific case-control studies). For the clinical and laboratory phases, it is suggested that random samples of 2,000 from each cohort be chosen. It is hoped that as many as 80% of those chosen will participate and, as with the questionnaire phases, if the pilot study shows rates much below the 7056 level, it will be necessary to question . the wisdom of proceeding with the main study phases. The number 2,000 was chosen because samples between 1,500 and 2,000 will give good power (alpha = beta * 0.05, 1-tail) to detect 2.5-fold increases in the risk of outcomes which usually occur at the rate of l.OX. * �(The major health outcome categories from which the questionnaire and clinical laboratory phases will be developed during protocol design and review are listed in a later section of this outline.) Study Sequences Three phases are planned for each of the 2 studies and each phase will culminate in a separate report. The 3 reports will concern 1) mortality experience of the cohort members; this phase of the study will also give an indication of the proportion institutionalized, 2) the results of the health questionnaire, and 3) the results of the clinical and laboratory tests. It is anticipated that work will proceed first on the Vietnam Experience study oecause there will be less work involved in selecting the cohort members than there will be for the Agent Orange study. Within each study, ascertainment of vital status will be a part of the process of locating cohort members for the health questionnaire and clinical/laboratory phases. Thus, mortality analysis will be completed first; reports on the health questionnaire and clinical/laboratory analyses will follow later. Even though these studies are subdivided into phases, it is expected that at some point in time work will be proceeding simultaneously on both studies (see schedule, later in this outline). The major steps which will be required to complete the two studies are (after full protocol design and approval and after pilot testing of procedures): 1) Selection of individual cohort members by the Army Agent Orange Task Force (AAOTF) For the Vietnam Experience study, identifying information about the cohort members will be transmitted to CDC immediately after selection. For the Agent Orange study much more work will be required of AAOTF personnel because of the need to review exposure information. Identifying information about cohort members for each study will arrive at CDC in small batches, possibly on a monthly basis, as they are selected. Therefore, the selection will be done in such a way that an appropriate balance of "exposed" and "non-exposed" for the Agent Orange study and of Vietnam and non-Vietnam veterans for the Vietnam Experience study are included in each batch. 2) Vital Status Determination and Location of Cohort Members As soon as a batch of information for study individuals is received, a check will be made against the Beneficiaries Identification and Records Location System (BIRLS) files and the National Death Index to try to ascertain those individuals who are deceased. For those who are found to be dead, collection of death certificates, pathology reports and other relevant material will ensue. Procedures to determine the location of those currently alive will begin simultaneous with the checks against the BIRLS and National Death �Index—the first step will be to check against Internal Revenue Service (IRS) files, which is a rapid and inexpensive method to obtain relatively current addresses for taxpayers. For those individuals who are not found on the BIRLS file or National Death Index and who are also not found on the IRS files, more expensive and time consuming methods of location will be used. The goal for both studies will be a location rate of 95% for those who are presumed alive. 3) Health Questionnaire Interviews of about A5 minutes in length will be conducted by telephone where possible. For potential respondents without telephones, personal interviews will be conducted at a place convenient for the respondent; for potential respondents who are institutionalized, personal interviews will be conducted at the place of instnationalization. The major outcomes from which questionnaire items will be chosen during the stage of full protocol development are listed later in this outline. The goal for both studies will be an interview completion rate of better than 90X of those located. A) Clinical and Laboratory Examinations Clinical examinations of the 2,000 individuals from each of the 5 cohorts will take place at 1 or 2 examining facilities, much like that used by the Ranch Hand study. The physical examination will include a standard, good quality review of systems. Multiple laboratories may be used for the various laboratory tests, but each particular test will be performed in a single laboratory. Special emphasis will be given to the clinical and laboratory outcomes which will be chosen during protocol development from among those which are listed later in this outline. �e Vietnam Experience Study Tentative Timetable This tentative timetable is divided into 2 phases - protocol development and study implementation. -However, some tasks which are formally a part of the implementation phase are scheduled to begin during the development phase. This approach is proposed so that there will be no unnecessary delays in the event that the protocol review goes smoothly and according to schedule. Month number 1 for each study phase begins at the time resources are made available to CDC by the VA. Study Phase Month Number Major Milestones recruit new personnel and short-term consultants for protocol development Protocol Development 3 0 4 0 0 complete development of protocol complete peer review of protocol complete preliminary work with military files for sample selection begin developmental work for contracts for questionnaire administration, clinical and laboratory work D 0 Study Implementation 1 complete OMB review complete selection of pilot study samples begin selection of main study samples begin final formatting of questionnaires and clinical instruments begin data collection for main study mortality analysis award contract for questionnaire administration �Vietnam Experience Study Tentative Timetable (continued) Study Phase Month Number Major Milestones 7 o begin questionnaire pilot study 10 o award contract for clinical and laboratory studies 11 o o begin clinical and laboratory pilot study evaluate questionnaire pilot study 12 o obtain OMB approval for any revisions to main study 13 o begin questionnaire main study 16 o evaluate clinical and laboratory pilot study 17 o begin clinical and laboratory main study 23 o complete study sample selection 32 o complete mortality study data collection 35 o REPORT mortality study analysis 36 o complete questionnaire data collection 41 o complete clinical and laboratory data collection 42 o REPORT questionnaire analysis 47 o REPORT clinical and laboratory data collection 7-/J �10 Agent Orange Study tentative Timetable Timetable for this study will parallel the Vietnam experience study timetable in the early phases (i.e., protocol development and review). Because of the extra time required to review military records for determination of Agent Orange exposure, data collection for the 3 study phases (mortality, questionnaire, clinical) will begin approximately 6 months after the comparable phase of the Vietnam experience study. Accordingly, the reports will appear 6 months later: Study Phase Study Implementation Month Number Major Milestones 41 o REPORT mortality study analysis 48 o REPORT questionnaire analysis 53 o REPORT clinical and laboratory data collection �• TECHNOUWV ASSESSMENT BOARD \ MOflRIS K. UDALL ARIZ.. CHAIRMAN TED STEVENS, ALASKA VICE CHAIRMAN OWN 0 HATCH, UTAH OCOKGE IITOWN, JR. CAUF. iSMcC. MATHIAS.Jl.MD. JOHN D WN6EU. MICH. I. KINNCDV, MASS. UUWV WINN, Jit. KANS. F, HOOINGS, S.C. ClAHENCE t MUM. OMO EPCLUIU COOHR EVANS, IOWA JOHNH.OMONI Congre** of t&e ttniteb fttau* JOHN H. GIBBONS OMCCTOR OFFICE OF TECHNOLOGY ASSESSMENT WASHINGTON, D.C. 20510 March 3, 1983 Honorable Harry N. Walters Administrator Veterans Administration 810 Vermont Avenue, N.W. Washington, D.C. 20420 Dear Mr. Walters: A little more than three years ago, in December 1979, Congress mandated that the Veterans Administration (VA) conduct a study of possible long-term health effects associated with exposure to herbicides, specifically "Agent Orange," during the Vietnam War. The same Public Law (PL 96-151) also directed the Office of Technology Assessment (OTA) to approve the design of and monitor the conduct of the study. Following passage of the law, VA contracted with the University of California at Los Angeles (UCLA) to design the study protocol. As required by PL 96-151, OTA reviewed each draft of the UCLA design and reported its comments to the Veterans Affairs Committees and the Appropriations Subcommittees on HUD and Independent Agencies in both the House and the Senate. In June of 1982, OTA approved the UCLA protocol and urged that the VA test several aspects of the protocol in preparation for the full-scale study. In September and October of 1982, criticisms of VA's handling of the study reached a crescendo, and VA began negotiating an agreement with the Centers for Disease Control (CDC). According to that agreement, signed in January 1983, CDC is responsible for designing and executing the study. By mid-January, CDC had prepared an outline of the proposed study. OTA received a copy of CDC's outline on February 2, 1983. Copies were forwarded to the members of the OTA Agent Orange Review Advisory Panel (membership roster appears at the end of the enclosed review), and the members mailed or phoned in their comments to OTA staff. As a result of the CDC involvement in the study, this OTA review is being sent also to the Congressional Committees with jurisdiction over the Department of Health and Human Services. Those Committees, the Senate Committee on Labor and Human Resources, the Subcommittee on Health and the Environment of the House Committee on Energy and Commerce, the House Appropriations Subcommittee on Labor Health and Human Services - Education, and the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies will be included In all mailings and reports from OTA concerning Agent Orange. �Page Two OTA Is pleased with CDC's outline. In a few pages, It presents convincing information that they have grasped the complexities of the problem and devised or soon will devise methods to carry out the study. CDC has tackled the problem of whether to study Agent Orange or the broader "Vietnam experience" by proposing two studies. The option of studying the Vietnam experience is provided by PL 97-72, passed in November 1981, which gives the VA Administrator discretion to expand the scope of the study from a focus solely on Agent Orange to the broader question. The two studies together address the questions of greatest concern to veterans and their families: What, if any, are the health effects of 1) exposure to Agent Orange, and 2) service in Vietnam, which may have included exposures to Agent Orange, other chemicals, drugs, and other factors in an exotic environment? OTA is in full concurrence with the proposed studies as they have been outlined. CDC expects to complete the drafting of a protocol in late April or early May. That date now appears realistic to CDC, but some concern has been expressed that completion of the protocol may be delayed unless personnel positions promised to CDC in connection with these studies are Indeed made available. OTA will, as required by PL 96-151, review that protocol within 30 days and final approval of the protocol will be considered at that time. For your information, I am enclosing a copy of a paper that was presented at the 1982 Annual Meeting of the American Public Health Association by Michael Gough and Hellen Gelband. The paper provides a review of events since the passage of PL 96-151. If Committee Members or staff desire further information about Agent Orange or OTA's role in the Congressionally-mandated study, please call me (224-3695) or Dr. Gough, director of the OTA review, or Ms. Gelband (both at 226-2070). Sincerely, Enclosure �Office of Technology Assessment w Review of the Centers for Disease Control "Protocol Outline and Tentative Timetable for Epidemiological Studies of the Health of Vietnam-Era Veterans (Agent Orange)" March 1983 Brief Description of the Proposed Studies The Centers for Disease Control's (CDC) outline lays out a plan for two concurrent studies: an Agent Orange Study and a Vietnam Experience Study* The former will concentrate on the health effects of exposure to Agent Orange. The latter will assess health effects of service in Vietnam. The basic design — an historical cohort study — will be the same for both studies, but the studies will differ in the details of cohort selection and data collection. The health outcomes to be Investigated in the two studies were not specified in the CDC outline, but there is expected to be some overlapping of the outcomes between the two studies. The Agent Orange Study will compare three cohorts of 6,000 men each: 1) troops defined as "exposed" to Agent Orange, who served in combat areas; 2) troops defined as "non-exposed" to Agent Orange, who served in combat areas; and 3) troops defined as "non-exposed" to Agent Orange, who served in non-combat areas. Veterans of the Army and probably the Marine Corps will be included in the Agent Orange Study. The Vietnam Experience Study will compare two cohorts of 6,000 men each: 1) veterans who served in Vietnam; and 2) veterans who served during the Vietnam era but did not go to Vietnam. Veterans of the Army, Navy, and �Marines and, If records permit, the Air Force, will be Included in the Vietnam Experience^Study. CDC describes three basic components for each study: 1. A mortality assessment (mortality followup will be repeated every 5 years for the foreseeable future). 2. A health and exposure questionnaire, which will differ somewhat for the two studies, to be administered by telephone when possible! The goal is to secure the participation of more than 90 percent of those located. Participation rates much under 70-75 percent will be cause to consider not proceeding with the studies. 3. Clinical and laboratory examinations, to be conducted on a random sample of 2,000 from each cohort. Examinations will take place at one or two facilities. The goal for'participation for this phase is 80 percent; less than 70 percent would be cause for concern. CDC's strategy is well thought out and sound. They clearly and concisely describe the basic structure for the Agent Orange and Vietnam Experience Studies. CDC has, in a very short time, become aware of the many difficulties of doing these studies. The imperfect knowledge of exposure to Agent Orange, which, in CDC's words, "will forever remain so," has driven the design of the Agent Orange Study. Together, the studies fulfill the Congressional mandates of both PL 96-151 (that called for a study of possible health effects associated with exposure to Agent Orange) and PL 97-72 (that authorized the VA to expand the scope of the study to investigate possible health effects associated with service In Vietnam). �The studies proposed in the outline address the questions of greatest concern to veterans and their families: What, if any, are the health effects of 1) exposure to Agent Orange, and 2) service in Vietnam, which may have included exposures to Agent Orange, other chemicals, drugs, and other factors in an exotic environment? OTA is in general concurrence with the proposed studies as they have been outlined. Final approval will be considered when the detailed protocol is reviewed. CDC1B efforts to secure the advice and support of the veterans* organizations is applauded; The current outline has been discussed with the major organizations and their comments solicited. CDC mentions its desire for "mandatory...advance advice and consent" (p. 2, para. 3) from veterans' groups. While unanimous agreement is the ideal, what course would CDC take in the absence of unaminity? ' At this point, It remains for CDC to complete full-scale protocols for the studies. OTA understands that protocol development is proceeding and expected to be complete by about May 1983. Progress is hampered to the extent that CDC does not yet have the required personnel slots described as necessary to plan and execute these studies. Getting fully under way depends upon the Office of Management and Budget's completing transfer of the necessary positions to CDC. OTA is prepared to review the full protocol as soon as it is available. A meeting of the Agent Orange Advisory Panel will be convened and a report written within 30 days after receipt of the protocol as is required by PL 96- 151. �" General Comments CDC has made an impressive and laudable start toward planning and executing perhaps the most difficult and certainly the most controversial epidemiologic studies of our time. OTA, because of its Congressional mandate, feels no less responsible in assuring that the studies are the best possible. With that in mind, and in a spirit of cooperation, some general and specific comments and concerns are offered in the following pages. OTA has provided a copy of this review to CDC. Timetable CDC has presented a very optimistic timetable. The physical examination i schedule would require completing examinations on an average of 20 individuals per day, an enormous task for any institution. In addition, the time left between completing data collection and reporting results is quite short, considering that as many as 30,000 questionnaires and 10,000 physical examinations may be conducted. As the details of the studies are worked out, changes in the timetable might be necessary. Specification of Outcomes CDC has not yet specified any health outcomes that are of interest for either study* To some extent, data collection instruments and clinical examinations depend upon looking for specified conditions and symptoms. Significant health effects for the two studies may differ considerably. For exposure to Agent Orange, there are suggestions, from both animal studies and epidemiology, that some health effects are more likely than others. �Hypotheses about effects of the Vietnam experience have been aired to a much _ lesser extent. For health effects more plausibly associated with exposure to either Agent Orange or Vietnam in general, the studies can be seen as "hypothesis testing." For other possible, but unexpected and biologically less plausible effects, the studies will be "hypothesis generating." In the full protocol, some distinction should be made between the more and less likely outcomes, allowing also fcr entirely unexpected findings. Tests of specific hypotheses should state, to the degree possible the number of events that are expected, the confounding variables and the potential methods of analysis. The authors of the outline mentioned the expected usefulness of the ongoing CDC birth defects study and the Ranch Hand study in developing the protocols. Although we are certain that CDC is aware of the Australian Agent Orange study, we mention it here because it may contain important lessons for the design of the CDC studies. Conditions for Participation No mention is made in the outline of possible incentives for participation in the studies. This is particularly important for the 10,000 veterans selected for clinical examinations. With only one or two examination centers, a significant amount of time will be needed to complete the examinations. Furthermore, veterans selected for examination will be inconvenienced by having to travel to an examination center. This is an area where the veterans* organizations will likely be extremely helpful, both in suggesting fair and equitable solutions and in helping to obtain cooperation from veterans. This aspect will affect the participation rate and therefore the integrity of the study and should be brought into consideration early on. f-7 �The Agent OTange Study The outline properly acknowledges the difficulties of assigning veterans to "exposed" or "non-exposed" cohorts in the Agent Orange Study. However, several specific comments made in the outline deserve elaboration in the protocol* The extent to which choosing "exposed" and "non-exposed" cohorts from the same area of Vietnam will increase the chance of mlsclassiflcation (p. 3, para. 2) deserves exposition. If the "areas" are very small, chances of misclassification might be very high; if they are larger, the chances should be smaller. The arguments advanced for including Cohort 3 in the study stem from the problems of misclassifying veterans between "exposed" and "non-exposed." Addition of that cohort will increase the size and cost of the study. Attention should be given to estimating the magnitude of the misclassification problem in order to justify inclusion of the third cohort. The protocol designers, if they choose to include the third cohort, should discuss possible interpretations if health outcomes differ between Cohort 2 and Cohort 3, both of which are "control groups." The protocol designers might also reserve a final decision about the third cohort until the pilot study is complete. The pilot study may shed a great deal of light on the magnitude of possible misclassification. The characterization of the study design as "incomplete" (bottom of p. 3) because one cell ("no combat"-"Agent Orange exposure") of a 2 X 2 table cannot be filled seems inappropriate. The fact that logically a cohort of veterans does not exist in the cell of a hypothetical table does not make the design incomplete. Rather the absence of those veterans dictates the type of study that can be done. ' O M �The Vietnam Experience Study Description of the Vietnam Experience Study is rather sketchy. OTA is concerned that the groundwork for the Vietnam Experience Study may need to be laid more fully before the study can begin. CDC foresees being able to begin this study before the Agent Orange study gets under way. Since the passage of PL 96-151 in December 1979 and even before, attention has focused on Agent Orange and its possible effects. Vietnam experience. CDC is breaking new ground in studying the The outline states that the Vietnam experience comprises many factors which are "unknown, poorly defined or not quantifiable." OTA expects that the protocol will contain some discussion of these and the better known factors. This task should not be underestimated. The existing literature about the effects of war must be consulted, but that will not be sufficient. In addition to the stresses and exposures common to all wars, Vietnam presented new and varied conditions which, to the extent possible, should be made explicit. The method of cohort selection for the Vietnam Experience Study has not yet been worked ou*:. Again, a great deal of effort has gone into developing a cohort selection method for the Agent Orange Study. After three years of steady progress, that system may be nearly ready* While the conceptual problems for the Vietnam Experience Study cohort selection are fewer, CDC is pioneering this effort, and its plans and expectations need to be described fully. The truth of the "luck of the draw" (p. 5, para.l) — random allocation of soliders to Vietnam or to other theaters — requires further examination before the full study begins. A small scale comparison of randomly selected �representatives of the Vietnam and non-Vietnam cohorts on baseline variables could be considered to find out if, in fact, the two groups are similar* Standard epidemiologic techniques to improve comparability of the cohorts will undoubtedly be employed by CDC. The outline mentions a "cluster sampling of military units," but no details are presented. Will full companies be the sampling units for both the Agent Orange and Vietnam study? The full protocol should present the arguments for the chosen sampling method. It is not immediately apparent that the same sampling technique should be used for both studies. The practical need to limit participation in the Agent Orange Study to males has been argued and largely accepted during the past three years. The same arguments may or may not apply to the Vietnam Experience Study. OTA is » suggesting neither that women be included nor excluded, but that the question be considered by CDC. Specific Comments Sample Sizes The outline states that a rendom sample of 2,000 from each 6,000-man cohort will be chosen for clinical examination* Is a random sample the best approach? The alternative is to use information from the questionnaire interviews to select a proportion of the 2,000. A scoring system based on a combination of responses might be used to target high risk individuals, which in turn could increase the power of the examination sample. . Targetting only a portion, say half of the 2,000, would allow for unexpected findings from the randomly selected group, and would allow the examinations to begin before the interviews are completed. 8 �The outline is properly cautionary (p. 5, para. 3) in stating that the proposed studies will not reveal associations, between Agent Orange or Vietnam service and relatively uncommon health outcomes, speicific cancers, for instance. Examination of such associations, which may be suggested during the course of the outlined studies, may require case-control studies. The outline provides a brief description of the statistical power of the studies. When the protocol is developed, the power of the studies to detect Increases of specified magnitudes for each outcome should be included. Health Questionnaire The tentative list of items for the health questionnaire is seriously deficient in reproductive outcomes. Questions about infertility, birth i defects and miscarriages should be Included. These questions can, of course, be related to information now available and soon to be available from the Ranchhand study and CDC's birth defects study. General anesthesias as well as surgical procedures should be queried. Sensitivity to bisulfites should be considered in allergy section. A question about excessive salivation or drooling, and speech slurring should be asked. In the neuropsychiatric section, questions about hallucinations, flashbacks, phobias and fears might be considered. The protocol whould descuss how the study designers will interpret or employ possible contradictions between exposure classifications based on the exposure index and those based on individual recall at the interview. �Physical Examination Retina should be included in eye examinations. Peripheral pulses should be included in cardiovascular examination. The neurological portion of the physical examination does not specify the particular attributes that will be assessed except for "motor systems." The components are all standard for neurologic testing except for "emotional responses," which needs clarification. Also, it may not be necessary to include mental status when extensive psychological testing is also being done. As much as possible, sensory tests should be quantified and objective, rather than subjective measurements. This is particularly important given the fact that polyneuritis is one of the most plausible health effects of Agent Orange, based on animal and human evidence from studies of 2,4-D and 2,4,5-T. 4 Psychological Testing As noted in the outline, the psychological testing section requires additional consultative advice. In general, It appears that some selection of subtests from the instruments listed will be necessary and desirable. A slant more toward detecting emotional and affective disorders, and less emphasis than currently on cognitive disorders should be considered. The Diagnostic Interview Schedule ( I ) for example, might be an appropriate addition. DS, Another component of psychological testing that should be considered is a measure of an individual's perception of control of his environment (referred to as "desired health locus of control"), for which standardized tests are available* Laboratory Tests Consider adding a battery of endocrinology tests related to fertility. \S»** �Office of Technology Assessment AGENT ORANGE STUDY PROTOCOL REVIEW Advisory Panel Richard Remington, Ph.D., Chairman Vice President for Academic Affairs University of Iowa Iowa City, IA 52240 Margit Bleecker, M.D. The Johns Hopkins Medical Institutes School of Hygiene and Public Health Division of Occupational Medicine 615 North Wolfe Street Baltimore, MD 21205 Lewis Kuller, M.D. Dept. of Epidemiology Graduate School of Public Health University of Pittsburgh 130 DeSoto Street Pittsburgh, PA 15261 George L. Carlo, Ph.D. Epidemiology, Health & Environmental Sciences 1803 Building Dow Chemical U.S.A. Midland, MI 48640 Claire 0. Leonard, M.D. 1445 .Wilton Way Salt Lake City, Utah 84108 Neal Castagnoli, Jr., Ph.D. Department of Chemistry & Pharmaceutical Chemistry University of California San Francisco, CA 94143 Theodore Colton, Ph.D. Boston University School of Public Health 800 East Concord Street Boston, Massachusetts 02118 Mr. Frederic Halbert 12150 Banfield Road Delton, MI 49046 George B. Hutchison, M.D. Harvard University School of Public Health 677 Huntington Avenue Boston, MA 02115 Patricia King, Georgetown Law 600 New Jersey Washington, DC Esq. Center Avenue, N.W. 20001 John F. Sommer, Jr. The American Legion 1608 K Street, N.W. Washington, D.C. 20006 Mr. Theodore P. Sypko Veterans of Foreign Wars of the United States V.F.W. Memorial Building 200 Maryland Avenue, K.E. Washington, D.C. 20002 Mr. John F. Terzano Vietnam Veterans of America 329 Eighth Street, N.E. Washington, D.C. 20002 Mr. Monte C. Throdahl Sr. Vice President, Environmental Policy Staff Monsanto Company 800 N. Lindbergh Blvd. St. Louis, MO 63166 H. Michael D. Utldjlan, M.D. Corporate Medical Director American Cyanamid Company Wayne, NJ 07470 December 1982 �CONGRESSIGNALLY MANDATED REVIEW OF AN AGENT ORANGE EPIDEMIOLOGY STUDY Michael Gough and Hellen Gelband Office of Technology Assessment United States Congress Washington. DC 20510 Agent Orange and Phenoxyacid Herbicides Agent Orange, a 50:50 mixture of n-butyl esters of 2,4-dichlorophenoxyacetic acid (2,4-D) and 2,4,5-trichlorophenoxyacetic acid (2,4,5-T), was the herbicide most widely used during the Vietnam war. The mixture contained a number of contaminants, including varying amounts of the class of chemicals known as "dioxlns," which are by-products of the synthesis of 2,4,5-T. 2,3,7,8-Tetrachlorodibenzo-para-dioxin (TCDD), one of the most toxic chemicals known, was the most common dioxin. As much as 170 kg of TCDD may have been disseminated in Vietnam before 1970, when the use of Agent Orange was drastically curtailed because of studies done In the United States that showed 2,4,5-T caused birth defects In laboratory animals. . Estimated amounts of TCDD sprayed in Vietnam, which are based on concentrations of TCDD measured in small number of archived samples of herbicide, are little more than guesses. For one thing, there is no way of knowing how representative the stored samples are. It is generally assumed �that the herbicide sprayed in the early years, when few U.S. troops were in Vietnam, contained much higher levels of TCDD than did the herbicide used in the peak spraying years of 1967-69. Health Effects of Agent Orange and Its Contaminants The components and contaminants of Agent Orange have been tested for toxicity in a number of animal systems. They have been found to be teratogenic and carcinogenic in animals, and, in fact, are toxic to essentially every organ system in one or another experimental animal. At the present, there is no evidence from epldemiologlc studies that Agent Orange, as used in Vietnam, has caused any adverse long-term health effects. However, studies in other settings have produced evidence of associations between exposures to phenoxyacid herbicides and certain cancers. The most convincing evidence of human carcinogenicity is from studies that showed an association between phenoxyacid exposure and soft-tissue sarcomas. The first published evidence was two case-control studies from areas in Sweden where herbicides were extensively used in forestry and agriculture. Corroborating evidence comes from a number of studies of exposed workers in this country which showed an association between soft-tissue sarcomas and phenoxy acids. A number of studies done elsewhere in the world, however, have not detected an Increased risk of soft-tissue sarcomas. Coggon and Acheson, who reviewed the evidence linking phenoxy herbicides and cancer in man, judged the evidence strong enough to warrant further study of this rather diverse group of tumors (The Lancet. May 8, 1982, pp. 1057-1059). Most �of the health effects that have been suggested as sequelae of Agent Orange exposure have not been studied In human beings at all. A Congressionally Mandated Study of Possible Health Effects Resulting from Exposure to Agent Orange Since the end of the Vietnam conflict, attention has been drawn to adverse health effects being suffered by veterans* To a major extent, complaints centered on Agent Orange as a possible cause, and in December 1979 the U.S. Congress responded to the concern and complaints. Public Law 96-151, passed at that time mandates that the Veterans Administration (VA): conduct an epidemic-logical study of persons who, while serving in the Armed Forces of the United States during the period of the Vietnam conflict, were exposed to any of the class of chemicals known as 'the dioxins* produced during the manufacture of the various phenoxy herbicides (including the herbicide known as "Agent Orange") to determine if there maybe long-term adverse health effects in such persons from such exposure. In the same law. Congress directed that the study be "conducted in accordance with a protocol approved by the Director of the Office of Technology Assessment [OTA]," and further that the OTA Director monitor the conduct of the study. The task of approving and monitoring an executive branch study is an unusual one for OTA. As one of the four Congressional support agencies -- the others being the Congressional Research Service (CRS), the General Accounting Office (GAO), and the Congressional Budget Office (CBO) — OTA is charged with providing unbiased information about technical matters to assist Congressional decisionmaking. The Office is organized into nine programs, Including the Health Program, where the Agent Orange project is located, and it prepares �reports, upon request from Congressional committees, about the applications, implications, Impacts, and possibilities of technologies. As will be seen in this paper, CRS and GAO, as well as OTA, have been involved in the attempts tp resolve the controversies around Agent Orange. The Constitutional Issue of Separation of Powers The President signed the lav mandating the VA study and OTA's role in it in late December 1979* A few days later, on January 2, 1980, he vetoed a bill that required the Department of Health, Education and Welfare (HEW) to undertake a study of the possible long-term health effects resulting from occupational exposures to dioxlns. The HEW bill, like the VAblll, mandated that the OTA approve the study plan and monitor the conduct of the study. In < his review of the HEW bill, President Carter decided that the requirement that OTA, a Congressional agency, was to approve an Executive Branch study was a violation of the separation of powers between the Legislative and Executive branches of government. The law was, in his view, unconstitutional. In his veto message, the President stated that although he had signed the VA Law, he had instructed the VA Administrator to ignore the provision that OTA was to approve the study plan. His reason for so instructing the Administrator was the same as for vetoing the HEW bill; he caw the OTA approval role in the study as a violation of the separation of powers. The question of the constitutionality of OTA acting to approve Executive Branch studies was referred by the Senate to the American Law Section of the CRS. In the opinion of CRS, which works for Congress, OTA's role was constitutional, and the President's veto was without merit. Of course, the �Executive Branch has lawyers too, and It turned to the Justice Department and asked for an executive branch opinion. Not unexpectedly, the Justice Department agreed with the President's veto. Congress then went back to CHS and asked them to comment on the Justice Department opinion. As you might expect, CRS reaffirmed its earlier conclusion that the OTA role was constitutional and that the veto was not Justified. Since neither branch of government has elected to go to court to resolve the constitutionality of the bill requiring OTA approval of the HEW study, there is no answer to the questions raised by the HEW bill and its veto. So far as we know, there has been no request for legal opinions about the President's instructing the VA to ignore the Congressionally-mandated requirement for OTA approval of the VA study. Soon after President Carter issued his instruction, Senator Cranston, who at .that time was Chairman of the Senate Veterans' Affairs Committee, wrote to the VA Administrator and suggested that ignoring the law of the land was not a wise course of action. Be pointed out that Congress must approve funds for the study and that Congress will require OTA approval of the study plan. The working relationship between OTA and VA, and, indeed, between OTA and all the executive branch agencies involved In Agent Orange, has been generally cordial and cooperative. For instance, OTA was named as an observer and has been an active participant in Executive Branch working groups concerned with Agent Orange. Changes in Opinion About the Possibility of Executing an Agent Orange Study Two types of information are necessary to determine who was likely to 2-tf �have been exposed to Agent Or.ange. The first is knowledge about where and how much of the herbicide was used; the second is where troops were relative to the herbicide. Before late 1979, there seemed to be no reason to try to determine who night have been exposed because the Department of Defense claimed that ground troops did not enter areas that had been sprayed until four to six weeks after spraying. By that time, it was thcjght that most of the Agent Orange would have been degraded. That opinion was discredited by the results of a GAO study published late in 1979 (U.S. Ground Troops In South Vietnam Were In Areas Sprayed With Herbicide Orange. United States General Accounting Office, Washington, D.C., November 16, 1979). GAO showed that relatively large numbers of Marines (about 5900 in I Corps, the northern section of South Vietnam) were within 0.5 kilometers of areas sprayed with Agent Orange on the day of spraying. In fact, some units were directly in the path of spray missions. Equally important, the methods used by GAO showed that the movement of troops, at least at the battalion level, could be tracked over the course of time, and their movements and positions matched with the locations and times of Ranch Hand spray missions. At the time of the GAO study, the only information available about Agent Orange use was Air Force records of spraying from fixed wing aircraft, C123's, during Operation Ranch Hand* During the last two and a half years, a group of Army records experts has wrung more and more information from the existing records. How Information is also available about spraying from helicopters, around base perimeters, and accidental exposures following jettisoning of large amounts of herbicides in emergencies. �During the period when It •earned impossible to study the effects of Agent Orange, Congress wrote a law that allows the VA Administrator, if he deems it appropriate, to: expand the scope [of the study]...to Include long-term adverse health effects...[from] other herbicides, chemicals, medications, or environmental hazards or conditions... As more information about exposures became available, opinions changed, and in November of 1981, OTA and officials from the Executive Branch testified before the Senate that a study of Agent Orange appeared possible. However, development of additional exposure Information did not dampen all enthusiasm for studying the Vietnam experience, either by itself or as part of the same study that focuses on Agent Orange. Development of a Protocol for the Study of Ground Troops Exposed to Agent i Orange The VA acted quickly to develop a protocol after the enactment of PL 96151 in December 1979. In February 1980, the VA published its intention to have the study protocol prepared by a outside contractor, and in March, issued a Request for Proposal (RFP). Four proposals were received and were reviewed by the VA's selection board composed of government experts. In May, a legal challenge to the validity of the contracting process, brought by the National Veterans Law Center, stopped the contracting process. Resolution of the challenge was not complete until February 1981. and no work was done on development of the protocol during the time May 1980 through February 1981. During that time, another provision of the law requiring the Agent Orange study was activated: In the event that, the Director [of OTA] has not approved �•uch protocol during the one hundred and eighty days following the date of the enactment of the Act, the Director shall (I) submit to the appropriate commitees of the Congress a report descibing the reasons why the Director has not given such approval, and (II) submit an update report on such initial report each sixty days thereafter until such protocol is approved. The 180 days was up at the end of May 1980, which meant that from that time forward, the OTA director wrof to six Congressional committees every two months to let them know that he had not approved a protocol because, in fact, • there was no protocol to consider for approval* This condition did not change until August 1981. After resolution of the conflict about contracting procedure, the VA solicited and received revised proposals from the original bidders on the KFF. In early May 1981 a contract, calling for delivery of the study protocol in 60 days, was awarded to the University of California at Los Angeles (UCLA) School of Public Health. UCLA was granted an additional 30 days to revise the draft protocol after review comments were received from the OTA and other groups. After an initial visit to the Pentagon by the UCLA investigators revealed previously unknown records which were of great potential value for the study, UCLA requested and was granted a 30-day extension of the contract. The 90 days was a short time for preparing a protocol, and effectively UCLA had less time for certain tasks, because the VA had not arranged appropriate clearances for the investigators to examine Department of Defense documents needed to develop ideas about exposure. OTA Review . Each major OTA project has an advisory panel, composed of technical �experts and representatives of all major stakeholders in Whatever the topic may be. The OTA Agent Orange advisory panel includes four academic epidemiologists and blostatlstlcians; three industry representatives (a corporate medical director, a vice president for environnmental policy, and an epidemiologist), two of whom work for chemical companies named in a class action lawsuit brought by a group of veterans against the manufacturers of Agent Orange; representatives of three veterans organizations; two additional medical specialists (a neurologist and a specialist in birth defects); an academic pharmaceutical chemist; a lawyer, and a public representative who is a chemical engineer and who was a state toxic substances commissioner. The OTA advisory panel met in early September 1981 and produced a very critical review of the first protocol that VA received from UCLA. We reported to Congress and the VA that the protocol was so general and vague that it was impossible for OTA to consider approval. In part, the lack of detail was a consequence of the relatively short time UCLA had to prepare the protocol. But the expressed Intention of the investigators to withhold details to protect the Integrity of the study also contributed to the lack of detail. While we agreed that it might be preferable to withhold certain details of the • protocol from the public until the study is completed, it Is impossible to review such a protocol for the purpose of approving it. The DCLA draft protocol proposed a large cohort study of exposed and nonexposed veterans and five smaller studies to produce more immediate results. OTA recommended that UCLA drop the five preliminary studies of mortality and morbidity and concentrate on the proposed long-term cohort study. , The VA decided that the first document was not acceptable even as a draft protocol, which meant that UCLA would have two opportunities for revision. �The protocol writers received a 90 day period to produce what would be considered as-the draft protocol, and a 30-day revision period to respond to reviewers' comments. After some delays, the VA received the new draft protocol in late January 1982. The OTA advisory panel met in mid-February to consider the new document, which was a vast improvement over the original. The protocol Included a proposed questionnaire and physical examination for the study, generally described a well-considered study, and dropped the five preliminary studies that OTA had criticized. It was not a finished protocol that could be put to immediate use, but it did provide enough information for OTA to identify the items that needed further attention and to make suggestions for improvements. i An Interesting feature of the January protocol was that it contained a proposed exposure index that had been developed by Department of Defense (DoD) representatives to the Executive Branch Agent Orange Working Group. The DoD document, which was an Appendix to the protocol, emphasized the possibility of expanding the study to include a third cohort. The third cohort would be made up of Vietnam-era veterans who had not served in Vietnam and would provide a comparison group to study the total effect of the "Vietnam experience." Neither UCLA as authors of the protocol nor OTA as reviewers endorsed the expansion of the study. Subsequently, in the fall of 1982, the National Academy of Sciences reviewed the protocol, and they, too, opposed expansion of the study. However, another review group, the Executive Branches Agent Orange Working Group, recommended expansion of the study to Include the Vietnam experience as a risk factor. UCLA's final document, which was accepted as meeting the terms of the �contract by the VA, did not contain plans for a third cohort. As it turned out, VA nevefdecided whether the study was to concern only Agent Orange or to be expanded to study the Vietnam experience. In March, OTA sent its review to Congress and the VA, along with a letter conditionally approving the protocol, pending further improvements. The UCLA Investigators accepted most of OTA's suggestions and produced a revised questionnaire and physical examination. OTA reviewed the revised protocol Internally, and sent a letter to Congress and the VA approving the protocol in June of this year. Events Subsequent to OTA's Approval of the UCLA Protocol In September 1962, almost three years after -passage of the law requiring . the Agent Orange study, a series of events began which resulted in VA's rellnguishing control of the study to another government agency. Charges repeatedly made that the VA was moving too slowly were voiced again at a House of Representatives Veterans' Affairs Committee hearing on September 15, 1982. Many of the Issues discussed there and some additional ones raised in a "60-day" letter from OTA Director Gibbons to Congress on September 30th focused criticism on VA. For instance, VA had employed neither an epidemiologist nor a statistician in its Agent Orange office, and it had still not decided between an Agent Orange only study and some other kind of study. Congressman at the hearing threatened legislation to take the study away from VA. A week later, 101 Congressmen signed a critical leter to VA, the Senate Veterans' Affairs Committee wrote a letter of general dlssatlslfaction, and, perhaps most important, no Representative or Senator came forward on behalf of VA. „ �A letter from Representative Montgomery, Chairman of the House Veteran's Affairs Committee, suggested that VA hand over conduct of the study to the Centers for Disease Control (CDC) In the Department of Health and Human Services (BBS). VA responded by writing to Secretary Schweiker of HHS to ask about CDC1 s takllng on the study. It is now a foregone conclusion that CDC will do the study through some contractual arrangement with VA, which will probably be signed In January 1783. The study will likely include 2 parts: one a study of Agent Orange; the second a study of the Vietnam experience. If so, the two parts will be conducted separately and each have its own control group. Summary » From its conception, this study of the possible long-term health effects of Agent Orange has been anything but a purely scientific investigation of a possible cause and-effect relationship. Congress mandating a study is somewhat unusual, and Congress's mandating the OTA review Is unique. The organization responsible for carrying out the study, the VA, suffers from a lack of credibility, whether deservedly so or not, among the people it serves, the same people who would stand to benefit from the results of the study. The exact importance of the lack of credibility in the decision to hand the conduct of the study to CDC cannot be measured, but it must have played a role. That action demonstrates that acceptance or rejection of the study depends not only on the integrity of the study design and execution, but to some extent on the general credibility of the organizations and Individuals who eventually carry out the study and Interpret the results. Evaluation of OTA's role in the Agent Orange study is difficult. 12 . �However, Congressional Committee staff have expressed praise and appreciation for the OTA reviews, which have aided them in making sense of a complex technical issue. Furthermore, we have been thanked for keeping Congress Informed of developments that have not been directly related to the protocol. The Agent Orange study will surely go ahead and will probably be completed. However, as Important as it is to establish whether Agent Orange has caused long-term health effects, the study will leave some policy issues unresolved. Consider the outcome if the study is negative: Veterans have real complaints. A study showing .that either Agent Orange or the Vietnam experience is not the cause will not likely lead the veterans to stop pressing their cases and claims. Instead, they may ask for additional studies or for compensation as more just and, perhaps, less costly than additional studies. Consider that the study is positive: If relatively common diseases are associated with exposure to Agent Orange or service in Vietnam, someone will have to apportion the Impacts of the exposure or service in making compensation payments. Such problems will remain after the study is complete, and the government will be left with even more difficult decisions* Updated January 1983 13 �9. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Hearth Service Office of the Assistant Secretary for Health ^ MAR 4 1983 Washin9ton DC 2020t Donald L. Custis, M.D. Chief Medical Director Department of Medicine and Surgery •Veterans Administration Washington, D.C. 20420 Dear Dr. Custis: Thank you for your letter of January 13 regarding the interagency agreement related to the Agent Orange/Vietnam Experience Study which you signed on that date. I co-signed and returned the interagency agreement on January 14. As you suggested, we will include the periodic mortality followup effort as part of the Centers for .Disease Control study and will include it in the budget proposal in support of the full study. Also as you suggested, we v?ill not recommend that the Veterans Administration Medical Centers participate in or conduct examinations of veterans involved in the study. If it is decided that all study subjects receive a physical examination and laboratory workup, we will include that as part of the budget proposal. We are currently developing and will send you in the very near future a Fiscal Year 1984 budget proposal which will be our best estimate subject to change upon final approval of a protocol. As a final matter, 1 am pleased that the VA is willing to make an advanced payment of $3 million from its FY 1983 budget to initiate the study. Equally important, however, are the 28 positions and the 14 FTEs which are required this year. You should note however, that the personnel resources required in FY 1984 may be at least 55 depending on the outcome of the protocol development. Consistent with Sections III(B) and VI(A) of the memorandum of understanding, I am requesting that VA expeditiously take the action necessary to obtain OMB approval to transfer these resources. For your convenience, I have enclosed a draft letter to the Office of Management and Eudget. If further justification is needed for this request, please let me know. Sincerely yours, Edward N. Brandt, Jr., M.D. Assistant Secretary for Health Enclosure .- �Dr. Kenneth W. Clarkaon Associate Director Human Resources, Veterans and Labor Office of Management and Budget Old Executive Office Building, Room 262 Washington, D.C. 20503 w Dear Dr. Clarkson: The purpose of this letter is to request your assistance to transfer FTEs from the Veterans Administration (VA) to the Centers for Disease Control (CDC). As you know, the VA has been working closely with the CDC to develop a comprehensive Agent Orange/Vietnam Veterans Exposure Study. The enclosed material, which has been provided to your staff, provides a justification of the resources required to undertake this study. At the present time, we estimate that CDC will require 28 people to undertake this activity. The VA has already concurred by interagency agreement to transfer $3 million to CDC to design a protocol for the study. The VA has also agreed to allocate 28 positions and 14 FTEs in FY 1983. Personnel resources required in FY 1984 may be as many as 55 depending on the results of the protocol. As stated in the interagency agreement, CDC will be able to proceed with development of the protocol and preparations for study implementation only when full resources, including the requested positions and FTEs, are available. I am therefore requesting that you take the action necessary to transfer these positions and FTEs to CDC so that this study can be initiated. Sincerely yours, Conrad Hoffman % Assistant Deputy Administrator for Budget & Finance Veterans Administration �AGENT ORANGE-VIETNAM EXPERIENCE STUDY PROTOCOL DEVELOPMENT STAGE--FY 83 I. Program Objective To design a protocol for and conduct an epidemiologlcal study to detect any long-term adverse health effects In veterans of military service in Vietnam and of exposure to phenoxy herbicides (including the herbicide known as Agent Orange) and the class of chemicals known as the dioxins produced as contaminants in the manufacture of such herbicides. II. Program Mandate Public Law 96-151, Section 307, mandates that the Veterans Administration (VA) design a protocol and conduct an epidemiologic study to determine if veterans of the Vietnam conflict suffer long-term adverse health effects from exposure to dioxins produced in the manufacture of phenoxy herbicides including Agent Orange. Public Law 97-72 permitted the expansion of the protocol design and study to include exposure to other herbicides, chemicals, medications, or environmental hazards or conditions. Members of Congress recently urged the VA to "contract with the Centers for Disease Control (CDC), Atlanta, Georgia, to conduct all phases of the Agent Orange Study." The Administrator of Veterans Affairs, in a letter dated October 4, 1982, to the Secretary of the Department of Health and Human Services (HHS), agreed to have CDC conduct the study. An Interagency Agreement transferring from the VA to CDC the responsibility for the design, implementation, analyses, and interpretation of the epidemiologic study in accordance with Section 307(a)(l) of Public Law 96-151 as amended was signed by the VA on January 13 and by HHS on January 14, 1983. The agreement stipulates that CDC is not obligated to undertake the study unless adequate resources are provided. The Secretary of HHS, the Assistant Secretary for Health, and the Director of CDC have assigned a high priority to this complex epidemiologic study. The positions requested represent a positive response to this priority and are necessary in order to undertake and expedite this study. III. Workload Over the past few years an increasing number of Vietnam veterans have expressed concern that they have experienced an abnormally high frequency of certain illnesses. Much of their concern has been centered on their presumed exposure to Agent Orange, a herbicide that was widely used for military purposes in Vietnam. Agent Orange was contaminated with a highly toxic substance, dioxin, which is carcinogenic and teratogenic in experimental animals. It is possible that Vietnam veterans do suffer poorer health than their counterparts who did not serve in Vietnam; however, such poor health could be due to a variety of causes other than Agent Orange exposure. To answer these questions about the possible health effects of military service in Vietnam and exposure to Agent Orange, it has been agreed that CDC would design a protocol for and conduct an epidemiologic study. f-3 �In preparation for undertaking this task, CDC assembled a committee to consider options for study design. The outline of the study plan proposed" by this committee, which was submitted to the VA prior to the signing of an Interagency Agreement, calls for two separate but parallel studies. One study will compare the health of three groups of Vietnam veterans who differ in their presumed level of exposure to Agent Orange. The second study will compare the health of a group of Vietnam veterans with a group of Vietnam-era veterans who did not serve in Vietnam (the likelihood of Agent Orange exposure in Vietnam veterans will not be a factor in the selection of subjects for this second study). Individual veterans will be selected for study on the basis of information contained in existing Department of Defense records. The first phase of each of the studies will be a mortality followup of group members. The second phase of the studies will involve a health interview with each of the surviving veterans who can be located and who is willing to participate. The third phase of the studies will consist of physical and laboratory examinations. Each of the two studies will be preceded by a pilot study, the purpose of which will be to test all proposed study instruments and procedures. CDC will undertake to assemble a team of workers to: 1) develop a complete study protocol, including interview instruments, clinical and laboratory procedures, and study clearances including necessary information collection budget clearance packages; 2) have the protocol reviewed extensively by CDC staff and by outside consultants, including representatives of veterans groups; 3) work extensively with Department of Defense personnel to develop methods for choosing study subjects from personnel records, company-level action records, and a variety of herbicide-usage records; A) develop contracts to obtain private sector assistance in locating, interviewing, and examining study subjects; 5) establish procedures and staffing responsibilities for maintaining close and strict monitoring of the performance of selected contractors; and 6) develop the data collection system including data collection instruments, system design, data output formatting, programming analysis and interpretation schema and methods, and format for.reporting findings and recommendations. It should be noted that CDC, in conducting studies where much of the necessary labor is obtained from outside sources, requires close and strict monitoring of all contractors' performance. These studies, because of their highly visible nature, will require special oversight efforts. Moreover, because of the magnitude of the studies and because they are each composed of several phases which will require differing contractor capabilities, CDC expects that a number of contracts will be awarded. The 28 personnel requested will concentrate on the following areas/activities: �Project Director - Direct and supervise all aspects of the Agent OrangeVielnam Experience Study. Provide epidemiological and other scientific guidance'and coordination for protocol development and validation. Oversee development of scientific aspects of contracting instruments. Ensure that contractors follow protocol and ensure high quality data collection. Provide guidance on data analysis. Oversee report writing. Serve as.focal point for issues and concerns related to Agent Orange - Vietnam Experience Study. Project Manager - Responsible for all management and administrative activities related to the Agent Orange-Vietnam Experience Study. Provides and coordinates project activities relating to staffing, training, budgeting, procurement, interagency communication, and data systems. Epidemiologist (4, including one senior epidemiologist serving as team leader) - Design epidemiologic protocol for the Agent Orange and Vietnam Experience Study. Epidemiology group to be organized into two subgroups: one for health interview related activities, the other for physical examination activities. Conduct an ongoing review of related literature. Maintain ongoing liaison and dialogue with other related studies (Ranch Hand, Australian, NIOSH, etc.) and concerned Federal agencies and veterans organizations. Participate in peer review of protocol and incorporate accepted modifications. Participate in design of data base system and statistical analysis of these data. Participate in design of Request for Contract (RFC) and selection of contractors. Monitor contractors' performance for adherence to protocol. Assist in epidemiological analysis and report writing. Public Health Advisors (A) - Participate in the design and development of the study protocol, including definition of data bases and statistical analysis methods to be used. Two to be assigned to the health interview epidemiology subgroup, two to be assigned to the physical examination epidemiology subgroup. Serve as liaison to interested agencies, organizations, and individuals. Identify and evaluate other studies, related data, and information sources. Procure appropriate data and information. Provide programmatic consultation, oversight review to contractors and conduct performance audits. Program Analyst - Participate with project management in the design and evaluation of the study protocol and data gathering instruments (questionnaires) to ensure that data required at all points of analysis are valid and able to be input readily to the project's computer programs. Is Involved in designing data output formats and analysing their usefulness in meeting project goals. Computer1 System Analyst^ (2) - Initiate, maintain, and update automated information management/"system to incorporate input data and produce desired output information in the desired format. Participate in identifying and procuring hardware and software needs. Participate in defining related personnel needs and provide appropriate training. �Computer Programmer - Program computer to accept study input data and produce desired output documents. Maintain and review computer programs as required. Clerk-Typists (4) - Provide secretarial and clerical support for 16 professional staff. Maintain administrative files, answer telephones, make travel, conference, and meeting arrangements. Laboratory Chemists (3) - Design and coordinate laboratory aspects of studies, including internal and external quality control of laboratory functions. Develop and validate appropriate reference materials. Develop protocol for specimen collection and treatment, laboratory data processing coordination and collection. Advise project director in selection of outside laboratories and serve on laboratory surveillance and patient data review committees. Statisticians (3, including one senior to serve as team leader for statistical and all data processing requirements) - Participate in statistical design and development of the protocols by providing appropriate statistical models to meet the study's objectives. Determine sample sizes required to achieve desired precision. Determine when data collection procedures and mechanisms are appropriate for creation of computerized data files for the purposes of the study. Information/Communications Specialist - Serve as primary project contact for veterans and for public information inquiries, and as liaison with counterpart functions at DOD, VA, and veterans organizations. Originate periodic public reports on project progress. Advise on interpersonal and interorganizational communications aspects of the project. Questionnaire Design Expert - In participation with project scientific staff:design, evaluate,and validate a behaviorally practical and scientifically sound questionnaire (instrument) for use by contracted interviewers. Participate in training interviewers in use of the instrument. Public Health Advisor - Provide an immediate contact for agencies an-j organizations located in the Washington, D.C., area. Function as liaison to DOD in selection of cohorts. Establish and maintain working relationships with other Federal agencies (IRS, VA, SSA, etc.) to obtain additional identifying and locating information on selected individuals. Contract Management Specialist - Participate in the design and development of RFC's for the location, questionnaire administration, and medical examination of selected study participants. Participate in the review of contract proposal and selection of contractors. Participate in the negotiation, administration, and termination of related contracts. TOTAL 28 positions. �IV. Relationship to Base Positions This project will be conducted by the new organizational entity known as• the Agent Orange Activity of the Chronic Diseases Division (COD), Center for Environmental Health, Centers for Disease Control. Organizationally the project director will relate directly to the Director, CDD, who will serve as his immediate supervisor. V. Staffing Strategy The CDD is the organizational entity within the Centers for Disease Control charged with conducting epidemiologic investigation of potential adverse health effects related to environmental exposure. The dramatically increased concern related to toxic chemical and hazardous substance exposure has already taxed to capacity the CDD to fulfill its mission. Due to the complexities of the operational and technical problems involved and the scope of this study, other alternatives would not provide the capacity and linkage necessary to make the type of response appropriate to this priority. CDC needs these personnel resources to undertake this study. VI. Impact on Other Federal Programs The proposed study is only one part of the Federal effort to provide answers about the possible health effects of herbicides and their contaminants, and about the effects of military service in Vietnam. Other major Federal activities include: 1) CDC's ongoing study designed to determine if Vietnam veterans are at increased risk of fathering babies with birth defects; 2) CDC's NIOSH Dioxin Registry, which will assess the health effects of occupational exposure to dioxin during the manufacture of herbicides and related chemicals; 3) the U.S. Air Force's comprehensive health study of veterans who applied herbicides in Vietnam from fixed-wing aircraft ("Ranch Hand Study"); 4) the Veterans Administration's (VA) proportionate mortality study of Vietnam veterans; and 5) the VA supported protocol development for a study of twins, one of whom went to Vietnam and one of whom did not. �Office of Budget •nd Finance Washington DC 20420 Veterans "Administration WAR 1 7 1983 In Reply ftoftr To: Mr. John W. Merck Chief, Veterans Affairs Brand) Office of Management & Budget Room 2013 Washington, D.C. 20503 Dear Mr. Merck: Enclosed for your consideration is the proposed outline and request for personnel resources as submitted to VA by the Centers for Disease Control, DHSS, for the conduct of the epidemiological study mandated by Public law 96-151. Also enclosed is a copy of the Interagency Agreement between Veterans Administration and Centers for Disease Control. It is rry understanding that further justification for the FTE is being prepared by CDC and that a meeting of the principals involved is scheduled at OMB on March 18 to further discuss this natter. Sincerely, CONRAD R. HOFFMAN Assistant Deputy Administrator Budget 6 Finance Enclosure 04 �RETURN TO 1QA7 WAR 1 5 1983 10A7 £dtfara N. Mraadt, Jr., ef.D. Asaistaut Secretary far healt* liepartinent of kealt* * Kunum Service* w««iiiagtoat d.C. 20201 i>e*r Dr. Araadt: you for your letter of ttareb 4, 1963, in response to By latter of January 13. I au pleaaed to learn that yo» vilX complete, in the aear ruture, tbo rincal t«ar 1^<»towi&ct;propocal for tho ooo4uct of the epide^io logical study. It U ay uaa'«r»ta»dio^ that Wti and tl*w co^aic«»ut Coajrfttaioaal Coasaitteea will need buii^et figure eatiaacea fry fine*! y*ar t«r tna duration of tba »tudy. ay »tatf ia work lag cloa«ly with (he CJC ad*iai»tr*tiv« peraoitacl to iinaliz* tha a«taila for diaburain^ fund* fvon VA to CDC naing tba ^3 million currently available ia tba Fi 6i budget for Aj«at Ovaaje^rolated reae^rcb. It ia important to uuderataua that ta* authority for obli^atioa of taeae fua4» expire* at the *a4 ol the current fiscal year. Xnia fact adda to the ur««ncy for fimalisio^ CC3*a FY 64 resource tfa are alto working with CDC and OMB to expeditltmtly achieve a reeolutioa of to* aatter of p«r»onaci reaourcea neceaaary to complete the protocol anl initiate tne actual atuiiy. To that end, a Beating haa b«ea acheduled at OAJA on ttarch 18 at which ti.» CDC etaff will diacoaa ttie proposed atudy methodology and the justification for Oh3 approval tor ti»* 24 position ia Ft t>3 aud the additioaal fib tor W b4 and Xr\e Vet era us >\uaiiuiatrAtion will continue to nup^ort, in every vay po«»ible, Ci/C'a «£rorta to initiate the epide^iolo^ic atudy at the earliest date. jiucereiy, J L. C Director cc: 02C 101Bn(2) 10A7:BSE£PARD:liAB:3-15-b3 IDA? 4-9 ' f �DEPARTMENT OF HEALTH & HUMAN SERVICES ate . March 17, 1983 Public Health Service Centers for Disease Control Memorandum From Chief. Cancer Branch, CEH/CDD Subject Duties related to 28 Requested Agent Orange Projects Positions To Daniel VanderMeer Associate Director, CEH O be hel Oranae Projects personnel needs to OMB.*ful orange *** ** explaining thelaroo »ana^ent system such as that which .we plan to these large and complex investigations, it is virtually Question; What is the difference between the project director and the project manager? Answer: The project director will have overall responsibility for the planning and execution of CDC's studies. The director will be a scientist (epidemiologist) and concentrate on providing scientific direction. The project manager will also have major overall responsibility for the planning and execution of the studies, but will concentrate on the numerous administrative matters which inevitably arise in the conduct of such studies. Question! What is a Public Health Advisor? Answer; A Public Health Advisor is a lay public health worker. Host of CDC's top administrative officers (in the non-scientific, non-medical categories) have risen through the Public Health Advisor ranks. The Agent Orange Projects Program Manager will be a Public Health Advisor. �Duties Related to 28 Requested Agent Orange Positions Page 2 Question; What Parts of CDC's studies will be done "in-house" and what parts will be done under contract? Answer : In summary, CDC staff will: a) Design the full study protocols, including; 1) specification of all items to be included in interview, examination and laboratory phases of the studies; 2) design of interview instruments; 3) .design sampling methods and criteria for the eligibility of potential study subjects, and methods for locating study subjects; 4) design data analytical methods; 5) define criteria and methods for ensuring quality collection of interview, examination and laboratory .data. b) Assist .the Department of Defense in the selection of study subjects. c) Perform the first steps of locating study subjects (primarily in con junction" with the Internal Revenue Service). d) Develop contracting instruments, review proposals and select contractors. Separate contracts will be awarded for the following areas: 1) location of study subjects and interviewing; 2) clinical examinations (more than one contract likely); and 3) laboratory tests (more than one contract likely). e) Monitor contractors' performance. This will likely include CDOperformed quality-control checks of interviews, clinical examinations, and laboratory tests. Pull-time on-site monitors will likely be required for interview and clinical examination contractors. f) Perform highly specialized laboratory tests for which no qualified private contractors are available. g) Set up and monitor systems for data base management. h) Develop and test data analytic methods and procedures; test methods on simulated data. i) Perform data analysis. j) Write reports on study findings. �Duties Related to 28 Requested Agent Orange Positions page 3 CDC's contractors will be responsible for: a) finalizing the format of the interview, examination, and some laboratory procedures; b) locating and interviewing study subjects; c) performing clinical examinations; d) performing standard laboratory tests; and e) editing raw data to provide CDC with "clean" data for analytic purposes. Question; Why are several statisticians, epidemiologists, and public health advisors needed? Why are they needed for the duration of the studies? Answer; The studies will require a matrix management system. The tasks to be .undertaken by the various specialists will vary with the stage of the project. In the developmental phases, a team comprised of an epidemiologist, a behavioral scientist, a statistician, and public health advisor will concentrate on the health interview, another similar team will work on the clinical examination, while another team (including laboratory scientists) will work on development of appropriate laboratory protocols. A separate team of computer scientists will work on assessing the data processing heeds of the projects; computer scientists will also devise specifications for contracts and handle early data manipulation tasks required for protocol development and pilot testing. As the studies progress beyond the development stage, the teams will be reconstituted so as to comprise a team which will include all specialists for the Agent Orange study and another team for the Vietnam Experience study. The various specialists are needed for the duration of the study to ensure that the data which will' be developed by contractors will be of the best quality obtainable. The importance of close monitoring of contractors by both scientific and administrative staff cannot be overemphasized. In large measure, this derives from the fact that CDC will be contracting for data collection only—little or no design or analytic services will be purchased. If CDC were to be provided with the substantial numbers of additional positions which would be required to do the labor of data collection "in-house," a more extensive management operation would be required. �Duties Related to 28 Requested Agent Orange Positions Page 4 Moreover, it will be important to provide for continuity in the management of the studies, particularly from the standpoint of scientific management. The design of studies by a scientific team assembled now, followed by analysis of data several years hence by another team would violate important principles of good study conduct—evaluation of data collection requires intimate knowledge of the scientific aspects of study protocols and sound data analysis requires extensive knowledge of potential weaknesses and errors in the data. These principles can only be followed if a continuity of personnel is maintained for the whole course of the studies. As mentioned earlier, the projects will utilize a matrix management system, shifting personnel to meet needs as they present over the duration of the studies. Simultaneous with the phasing out of some front end.activities in early FY 84, personnel will be shifted to other activities and reorganized to initiate the following activities: 1. Develop RFP's for questionnaire administration (30,000 participants) and medical examinations (10,000 participants). Solicit contractor proposals. 2. Review and select contractors, orientate and consult with contractors. Put in place a logistical system (travel, etc.) for participants in medical examinations. 3. Select pilot sample of 1,500 (5% of 30,000) and conduct demonstration studies. 4. Monitor contractor's performance and evaluate data provided by them. Hake necessary or appropriate adjustments to the systems/protocols. 5. Recruit and orientate additional staff to monitor/oversee contractor's performance and process data. • 6. Initiate full scale studies at the rate of approximately 1,000 participants per month. 7. Monitor and provide consultation to contractors and evaluate incoming data for efficacy and flow of participants through studies system. J. David Erickson, D D S , ... Ph.D. �Director Centers foY Disease Control f • Agent Orange Epideiaiologic Study Budget Options - ACTION The Assistant Secretary for Health : Through: ES/PHS BACKGROUND The Veterans Administration (VA) and the Centers for Disease Control (CDC) have entered into an Interagency Reimbursable Agreement under which CDC will carry out the epidemiological studies authorized by Public Laws 96-151 (Section 307) and 97-72. The Agreement proposes that two related but separate epidemiological studies be conducted to determine whether Vietnam-era military veterans as a group, including those particularly Dost likely to have had significant exposure to the dioxin-contaminated herbicide "Agent Orange," suffer long-term adverse health effects. Funds and positions to design and conduct the studies are to be provided from monies appropriated to the VA. .The CDC intends that these studies: 1. Will be designed to resolve the issue of long-tern health effects resulting from military service in Vietnam (especially in areas where Agent Orange was used) as compared to service outside of Vietnam during the same period. . 2. Will be scientifically credible and compatible with one another so as to allow whatever interchange of data may be appropriate over time* 3. Will result in significant savings by a Vietnam Experience study being conducted simultaneously with one directed primarily to Agent Orange exposure. VA and CDC officials agree that both veterans and Congress are determined that both studies of the possible effects of Agent Orange exposure and the effects of military service in Vietnam be carried out. The Interagency Reimbursable Agreement provides: 1. Financial support by the VA to the CDC in FY 83 for the developmental stages of the studies. 2. A mechanism ensuring continued support in FY's 84-37 for execution of the studies* contingent upon availability of funds and positions for implementation of the agreement, and for insuring that the necessary approvals for the study design are obtained. �Page 2 - The Assistant Secretary for Health rul Bptton except the Soft Tissue Sarc™ j - _ _- 0 iralid statements of correlation between service in Vietnam and health outcomes expected to be associated with dioxin exposure. •»•* ' "Several studies have indicated that a relationship may exist between exposure to dioxin-contaminated herbicides and the incidence of soft tissue sarcoma. An epidemiologic surveillance system will be established as a component of the CDC Recommendation, Full Service, Mid-Range, Low Budget and Soft Tissue Sarcoma Surveillance options. The systems will identify persons with soft tissue sarcoma and provide the basis for case-control studies to determine if Vietnam veterans are at Increased risk of developing this cancer. The question of cancer incidence is one of keen interest among veterans and CDC is convinced that this subject oust be investigated. Design implementation and management of the sarcoma surveillance will require $1,000,000 and 5 FTE's each year between 1934 and 1987. Each of the options (with .the exception of the Soft Tissue Sarcoma Surveillance and the Zero Cost options) call for collection of questionnaire data on living veterans among the 30,000 identified as participants and postmortem data on those who are deceased. The data analysis phase and the phase during which subsequent recommendations are defined are roughly comparable among each of the five options which involve studies. Thus, the major differences relate to the quantity and types of medical examinations called for by each option. . Since the period under study occurred approximately 15 years ago, locating these participants will be difficult and certainly costly. The most costly component of the studies, however, will be administration of comprehensive, "study quality," medical examinations (including laboratory work), and related expenses. �Page 3 - The Assistant Secretary for Health SLSSJ: t - - -^- «*• Interview,™ .x,rfne the The following sections briefly describe the oethodological differences among all six options an'd contain the argumenti the characteristics of .each. «".&u»«iti 1. CDC RECOMMENDATION * . ? ? ! 1 ? 1 r _ n e v e <l««tionnaire «ould be administered to all / ? ' r !! ?:e ltriw Cost estimates: FY 84-87 $72,400,000 55 FTE/YR •IM PROS:. Requires administration of significantly fewer yet an adequate number of study quality" physical examinations and laboratory tests without sacrificing statistical validity and scientific acceptability. for the Requires fewer resources (personnel, space, computer time,C ncra r contractors' services, etc.) than Full Service or Mid-Range options. ° "° CONS: * • * " lwrlt* <unwar"nt^) criticism of the *" ^ inf^ldual?4wh°want «ii " Participants to receive equally ^ The government could be criticized by veterans groups and others for tesJo to all participating veterans. health services <P*ysicals and ,<e?Ual.treatQent 8nd tests) tn° n �Page 4 - The Assistant Secretary for Health 2. FULL SERVICE OPTION A specialized questionnaire will be administered to all living participants or specialized postmortem data would be collected from 3 , 0 000 persons. Comprehensive, "study quality" medical examinations will be performed for all willing participants (potential maximum of 3 , 0 ) 000. Cost Estimates: • PY 84-87 $158,750,000 92 FXE/YR PROS: More veterans are likely to benefit by learning of illness or other conditions which might otherwise go undetected without the physical exams and laboratory tests received during these studies. Larger numbers of "study quality" physical exams and lab tests will yield larger (and potentially more useful) data bases for future analyses. Larger sample sizes are more impressive to nonprofessional critics of the study protocol and may stem their criticism. The government is less likely to be criticized by veterans groups and individuals for apparent failure to provide equal treatment and health services (physicals and tests) to all participating veterans. CONS: The number of persons to be examined exceeds the sample sizes required to achieve statistically valid and scientifically acceptable results, and the resulting costs afe significantly greater than options 1 and 3. Requires more resources (personnel, space, computer time, contractors' services, etc.) than any other option and would cost twice as much as the CDC recommended option. , "How much is enough?" Even 30,000 thoroughly examined and tested participants may be too few to convince a small minority of the studies* validity. 3. MID-RANGE OPTION Questionnaire or postmortem data would be collected from 30,000 participants. Comprehensive, "study quality" medical examinations would be performed for a statistically valid sample base of 10,000 participants ( , 0 from each of five cohorts). Less expensive, or "routine," "life 200 Insurance quality" medical examinations would be provided on request to participants who are not selected to receive the comprehensive examinations necessary for the epidezaiologic study. �Page 5 - The Assistant Secretary for Health For budget estimate purposes it is assumed that 502 of the 20,000 participantsVho would not receive "study quality" medical examinations will request routine examinations. None of the data from the routine physical examinations would be collected or analyzed by CDC or used in any other vay for study purposes. Cost Estimates: FY. 84-87 $84,000,000 79 FTE/YR PKOS: Requires administration of significantly fewer "study quality" physical examinations and laboratory tests -than the Full Service option without sacrificing statistical validity end scientific acceptability. Provides a means for participants who do not receive "study quality" medical examinations and who are concerned for their personal health to receive potentially helpful physical examinations. Data collection and management costs are less than for the Full Service option. Requires fewer resources (personnel, space, computer time, contractors* services, etc.) than the Full Service option. Reduces risk of criticism for failure to provide "study quality" physical exams for all participating veterans. CONS: Smaller sample sizes may invite (unwarranted) criticism of the studies* validity. Funds will be spent to provide physicals which will not contribute to studies' outcome. Veterans' health problems which might have been identified during exhaustive "study quality" physical exams and lab tests may remain undiscovered in study participants who receive less thorough or no physical exams. Groups and individuals who want all study participants to receive "study quality" physical exams and tests may be concerned by a decision to provide less thorough exams for come. The government is likely to be criticized by veterans groups and Individuals for apparent failure to provide equal treatment to all participating veterans. �Page 6 - The Assistant Secretary for Health *• LOW BUDGET OPTION <LFJ1 " -r"rT- •" •--'"-• ~- - f ---V- -*-r-f... , • The questionnaire or postmortem data would be collected on 30,000 participants. Mo medical examinations conducted. Cost Estimates: FY 84-87 ' $27,100,000 40 FTE/YK PROS: Requires fewer resources (personnel, space, computer time, contractors1 services, etc.) than Full Service, Mid-Range and CDC Recommendation options. Will take less time to complete the studies. CONS: There will be no medical exam data to confirm/validate responses to questionnaire. An integral component of the studies' protocol will be eliminated. Lack of physical exams and laboratory work will invite strong criticism of the studies' validity. Participating veterans' health problems, which might have been identified during physical exams and lab tests, may remain undiscovered. Groups and individuals who want all study participants to receive "study quality" physical exams and tests may be angered by a decision to withhold exams and tests. The government is likely to be criticized by veterans groups and individuals for failure to provide necessary health examinations (physicals and tests) to all participating veterans. 5. SOFT TISSUE SARCOMA AND LYHPHOMA SURVEILLANCE OPTION* Under this option only the retrospective soft tissue sarcoma and lymphoma surveillance system referred to in the general description of all other options which involve studies would be conducted. Cost Estimates PROS: . FY 84-87 $7,000,000 33 FTE/YR . Requires fewer resources (personnel, space, corapuier tize, contractors' services, etc.) than any option other than Zero Cast. �Page 7 - The Assistant Secretary for Health CONS: • ' . Fails to meet Congressional mandate. Fails to fully respond to Congressional and veterans* calls for Investigation of perceived health problems other than sarcomas. Non-responsive to interagency agreement with VA. 6. ZERO COST OPTION* Mo epidemiological studies will be. carried out after feasibility of doing the studies is fully explored. Hay not reflect now but may emerge for consideration. Costs Estimate: FY 84 $3,000,000 28 FTE PROS: *» Involves no resources beyond those expended to attempt to reach a valid protocol. • . • This option is presented only because it is recognized that it may not be possible to develop a protocol which is satisfactory or acceptable to the various scientific and policy review panels with review and approval authority. CONS: Falls to meet Congressional mandate. There will be severe criticism for failure to respond to Congressional and veterans' calls for investigation of perceived health problems. *Under these options it is anticipated that protocol development, review, and refinement will continue into FY 1984. FTE requirements would decrease to 5 for sarcoma option, and to 0 for Zero Cost option, for FY 85 and beyond. 9-J0 �Page 8 - The Assistant Secretary for Health RECOMMENDATION 4BM^««^M«M-MMM*BMnHMMiMM» f * I recommend approval of Option I, which we believe to be both scientifically acceptable and cost effective. Ap proved Di sapproved Da te If you concur, please sign the transmittal letter to Dr. Custis of the VA and forward with it the budget submission, prepared in their requested format. William H. Foege, M.D. Assistant Surgeon General cc: ES/PHS CDC/W ~OD ~CEH CDC:CEH:DVanderMeer/JGallagher :os Doc. 10318R 3-30-83 �.»«•*••"•«,, DEPARTMENT OF HEALTH 4 HUMAN SERVICES Public Health Service Centers for Disease Control Atlanta GA 30333 Donald Custis, K.D. ( 0 1) Chief Medical Director Veterans Administration 810 Vermont Avenue, NW. Washington, B.C. 20420 Dear Dr. Custis: Enclosed is the budget proposal for the CDC recommended option to conduct the Agent Orange Epidemiology Study for the period FY 1984 - FY 1987 A proposal for the soft tissue sarcoma case-coStrol study, as discussed Your expeditious review and submission of this request to the Office of Management and Budget will be necessary to ensure that it is aSnded to the Veterans Administration FY 1984 budget. laiLre to ^ Sincerely yours, Edward K. Brandt, Jr., M.D. Assistant Secretary for Health Enclosure �"AGENT ORANGE" EPIDEMIOLOGICAL STUDIES PROGRAM DESCRIPTION long-term advene health ««e«8 r n l t *^ ««ermlne the posslUe to chemical contaminants found"n"he nerhlS^ -I'0*"; °* W!tn" «tej"8 97-72 permitted the expansion of the%rot«S L f 8 *«*••" »«*«<= ^» exposure to other herMcldes? chemlLls ~dL«i *" ""' 8tUdy tO **?? or conditions, to XnteraMncv fcS^!; medications, or environmental hazards M 1 Department o* Health !n5S fe° * ° «""'»' »J n..es ar..r.n3an . -- 2 ^^ �yearTwno'nave'n? Wlil "entlfy -1« Patients between the ages =s or j^u 8ervicc in'vieJni" Vcontrot to establish the likelihood of exposure to Agent Orange of members of the control group who also served in Vietnam. The study results wUlte based inter reta T y P "°° of differences between the case % control S 9* �JUSTIFICATION OF ESTIMATES activities through n 87. "°St °* the «"tr«te<1 processing methods M t r,port"°«t" Doc. No. 3301N 3/30/83 it Ir n > " " t » l » . y ,MUty control.^rep^n of "' " ^ t r �AGENT ORANGE PROJECTS, CEHtCDD OBLIGATIONS BY OBJECT (dollars in thousands) 1982 Actual 10 Personal Services 1983 Budget Current Estimate Estimate 1984 Estimate 1985 Estimate 1986 Estimate 1987 Estimate 1988 Estimate $ 0' $ 900 614 $ 3000 $ 3150 $ 3300 $ . ^040 $ 0 55 138 193 39 99 138 300 60 360 42 30 30 21 Travel and Transport of persons: Employee Travel All Other Subtotal 22 Transportation of things 23 $ 315 . 20 33T 330 15 345 275 10 285 30 10 10 50 60 60 50 Communications, utilities and other rent t 49 24 Printing and reproductions i 13 10 25 50 50 30 25 Other Services (Contracts) I 117 111 53000 5000 20 20 9 6 10 10 10 10 26 Supplies and Materials 31 Equipment 35 1677 $0 1200 25 15 5 5 0 32 Lands and structures Total Obligations r 0 0 0 0 0 $3000 $2144 $56500 $8650 $3800 $3450 Doc. No. 3301M 3/30/83 • f $ 0 �Agent Orange Studies Budget Justification by Object Class FY 1984 27 FTE'e <« w mo/ ..t^i «_ .. . U *«*<*"« to carry 18 16 ^ ^ out the implementation 22 ~.-UBC UA outy Stacx0n ana equipment and records shipments. 23 £ J ; and Reproductions - Preparing ... printing IU«H.B*.ABJ.» • ^ 1 * and materials lincludintr nrntnt-nl \ f*~ «».c« _ _ « „ „ . 6 orientation and use in response to 24 25 . Other Services .- The contract mechanism will be utilized for oO each £nV JUaUtyBediCal ^^^tion to 10000 (§4,000 each). $2,000,000 in contracts will support information s°t«£ 2 additional1$5,000,000 is8°ft ""^sarcoma c^se-xontrol d i 8 7 1 ^ t0 a budgeted in F* 1985 to assure study. Aa a d S ? * ^ continuity and completion of contract activities. 26 i<eS " 1 1 . 31 p u "* f s e °fgeneral offlce and laboratory ^eM«?: ^ " , ^ ? ^oratory supplies, including reference materials and analytically certified controls for multiple analyses jo develop external quality assurance systems for contract laboratories, and storage facilities, containers and racks for ' maintaining quality control materials under stable conditions. 5 1 ! * " jntenan« and "Pg«ding of data processing and word ^ ! ? Ma processing equipment for conduct of studies. Acquisition of equipment necessary to assure the security of data. Doc. No. 3299N 3/30/83 �-7 . '/ • ^ / ' > . "W APR * Mr. Dale Sopper Assistant Secretary for Management and Budget Departn»ent of health and Human Services Washington, D.C. 20201 Dear Mr. Sopper: This is in response to your March 21, 19o3 letter to adjust tne Department of Health and Human Services full time equivalent (FTE) ceiling. The request to transfer responsibility for conductiny all phases of an Agent Orange study frora the Veterans Administration to HHS'sf Centers for Disease Control including 14 FTE in FY83 is approved. Since tnis study will be for a Halted duration, associated increases in your employrae/it ceiling will oe provided only until the study is completed. Therefore/, it is assumed that new employees associated with this increase will be appointed on a nonpercanent basis. i The transfer to the Deparfcaent of Justice's Goranrjnlty Relations Service of 13 FTE 1n FY83, effective March 7, 1983, fs approved. These are resources necessary for the Department of Justice to carry out responsibilities for Cuban and Haitian entrant reception and processing activities (transferred from HKS to Justice in FYS2). Adjustments in your FY84 FTE ceiling will be trade upon agreement with VA on the number of FTE to be transferred; and upon agreement between HHS and the Department of Justice on the nuaber of FTE to be*"transferred. Accordingly, the employment ceilings for the Department are revises as follows: Full-titae Equivalent (FTE) Employment FROM Total Employment 142,000 15 Total Employment 142,001 cc: Official file — IM Branch DO Records Director's Chron Mr. Wright Mr. Moran *'ir. LI am son , Hr. Kleinberg (2) u ^ •?_.!__«..•,', ur. «_ r - 3/29/83 9~ & 6 �APR 8 1883 Honorable Harry !! Walters •. Administrator of Veterans1 Affairs 810 Vermont A^*nuer N.W. Washington, D.C. 20420 • f Dear Harry: » This is in response to your request for additional employment for fiscal year 1983 to conduct the Agent Orange e]pideniological study transferred to the Centers for Disease Control, Department of Health and Human Services (DHHS). since the staffing for this study had not been included in the employment ceiling for your agency, the required 14 full-tine equivalent (<FTE) workyenrs are being provided to the Veterans Administration (VA) for use by CDC in the conduct of this study for fiscal year 1983. The net effect of this action is no change in your 19R3 employment ceiling of 217,113, with your additional 14 FTE provided to the . DHHS. / Sincerely, Joseph R. Wright, Jr. Deputy Director cc: Official File-VA Branch DO Chron Mr. tvright Mr. Moran Mr. Clarkson Mr. Strauss Mr. Modlin Mr. Martin (2) Mr. Kleinherg Mr. Zafra VA Chron * LVED:ARooney:jk 3/30/83 Rooney *7 "3/30/Walters' �Veterans Administration Department of Medicine and Surgery CIRCULAR 10-82-185 Washington, DC 20420 September 16, 1982 TO: Directors, Medical Centers, Medical and Regional Office Centers, Regional Offices, Regional Offices with-Outpatient Clinics, Domiciliary, and Outpatient Clinics SUBJ: Guidelines for Implementation of Legislation Related to the Provision of Health Care Services to Veterans Exposed to Dioxins 1. The "Veterans' Health Care, Training, and Small Business Loan Act of 1981" was signed into law on November 3, 1981. The Act, Public Law 97-72, authorizes the Veterans Administration to provide certain health care services, as described in paragraph 3, to any veteran of the Vietnam era (August 5, 1964 - May 7, 1975) who while serving in Vietnam may have been exposed to dioxin or was exposed to a toxic substance in a herbicide or defoliant used for military purposes. Verification of service in Vietnam during the Vietnam era (August 5, 1964 - May 7, 1975) will be required. In the absence of affirmative evidence to the contrary, a Vietnam veteran's contention of exposure will be accepted. 2. Health care services may not be provided under this law, for the care of conditions which are found to have resulted from a cause other than the specified exposures. 3. Health care services authorized under this provision are limited to hospital and nursing home care in VA facilities and outpatient care in VA facilities on a preor post-hospi tali zat ion basis or to obviate a need for hospitalization. Such health care services will be provided without regard to the veteran's age, serviceconnected status or the inability of the veteran to defray the expenses of such care. Veterans furnished outpatient care under this authority will be accorded priority ahead of other nonservice-connected veterans and equal to former Prisoners of War who are receiving care for nonserviceconnected conditions. Congress made it clear that this law provides for health care only, and that a determination that the veteran is eligible for such care does not constitute a basis for service-connection or in any way affect determinations regarding service-connection. THIS CIRCULAR EXPIRES ON SETPEMBER 15, 1983 �CIRCULAR 10-82- 185 September 16, 1982 4. Each veteran who served in the Republic of Vietnam and who requests VA medical care will be provided a physical examination and appropriate diagnostic studies as prescribed by DM&S Circular 10-81-54, "possible Exposure of Veterans to Herbicides During the Vietnam War." The examination and studies with a complete medical history will be documented in the medical record. If such an examination has been completed within the prior six months, only those procedures which are medically indicated by the current circumstances need be repeated. Where the findings reveal a condition requiring treatment, the responsible staff physician shall make a determination as to whether the condition resulted from a cause other than the specified exposure. In making this determination, the physician should consider that the following types of conditions are not ordinarily considered to be due to such exposure: '> a. Congenital or developmental conditions, e.g., spina bifida; scoliosis. b. Conditions which are known to have pre-existed military service. c. Conditions resulting from trauma, e.g., deformity or limitation of motion of an extremity. ) d. Conditions having a specific and well established etiology, e.g., tuberculosis; gout. e. Common conditions having a well recognized clinical course, e.g., inguinal hernia; acute appendicitis. 5. On occasion, the responsible staff physician may find that a veteran requires care for one or more of the conditions listed in paragraph 4, but that the case presents complicating circumstances that make the provision of care under this authority appropriate. In such instances, the physician should seek guidance from the Chief of Staff and the Environmental Physician regarding authorization for treatment. If treatment is so authorized, the reasons will be clearly documented in the medical record. Veterans who are not provided needed medical care under this circular may be furnished care if they are eligible under any other statutory authority. 2. �CIRCULAR 10-82-185 September 16, 1982 6. In the event the responsible staff physician finds that a veteran has a condition not ordinarily considered to be due to^the specified exposure and there are no complicating circumstances warranting the provision of care under this authority, the decision and its basis will be clearly documented in the medical record. 7. The provisions of this circular will not exclude any veteran who served in the Republic of Vietnam from being included in the VA's Agent Orange Registry Program as outlined in DM&S Circular 10-81-54, dated March 19, 1981. 8. These guidelines will be effective upon receipt. A copy of the pertinent guidelines should be made available to any veteran seeking care under this authority. 9. This circular rescinds DM&S Circular 10-81-249 dated November 18, 1981. w. j."&BOBY, JR., M.D: Deputy Chief Medical Director DISTRIBUTION: COB: (10) only plus (101B1) 30 and (102) 300 SS (102) FLD: MA-300 each and DO, OC & OCRO-lQfi each and RO-200 each plus 200-8 EX: Box 44-6, Boxes 60, 54, 52-1 each & 63-5 3. /0-Ti �Veterans Administration Department of Medicine and Surgery CIRCULAR 10-82-185 Washington, DC 20420 September 16, 1982 TO: Directors, Medical Centers, Medical and Regional Office Centers, Regional Offices, Regional Offices with Outpatient Clinics, Domiciliary, and Outpatient Clinics SUBJ: Guidelines for Implementation of Legislation Related to the Provision of Health Care Services to Veterans Exposed to Dioxins 1. The "Veterans' Health Care, Training, and Small Business Loan Act of 1981" was signed into law on November 3, 1981. The Act, Public Law 97-72, authorizes the Veterans Administration to provide certain health care services, as described in paragraph 3, to any veteran of the Vietnam era (August 5, 1964 - May 7, 1975) who while serving in Vietnam may have been exposed to dioxin or was exposed to a toxic substance in a herbicide or defoliant used for military purposes. Verification of service in Vietnam during the Vietnam era (August 5, 1964 - May 7, 1975) will be required. In the absence of affirmative evidence to the contrary, a Vietnam veteran's contention of exposure will be accepted. 2. Health care services may not be provided under this law, for the care of conditions which are found to have resulted from a cause other than the specified exposures. 3. Health care services authorized under this provision are limited to hospital and nursing home care in VA facilities and outpatient care in VA facilities on a preor post-hospitalization basis or to obviate a need for hospitalization. Such health care services will be provided without regard to the veteran's age, serviceconnected status or the inability of the veteran to defray the expenses of such care. Veterans furnished outpatient care under this authority will be accorded priority ahead of other nonservice-connected veterans and equal to former Prisoners of War who are receiving care for nonserviceconnected conditions. Congress made it clear that, this law provides for health care only, and that a determination that the veteran is eligible for such care does not constitute a basis for service-connection or in any way affect determinations regarding service-connection. THIS CIRCULAR EXPIRES ON SETPEMBER 15, 1983 �CIRCULAR 10-82- 185 September 16, 1982 f. Each veteran who served 'in the Republic of Vietnam and who requests VA medical care will be provided a physical examination and appropriate diagnostic studies as prescribed by DM&S Circular 10-81-54, "possible Exposure of Veterans to Herbicides During the Vietnam War." The examination and studies with a complete medical history will be documented in the medical record. If such an examination has been completed within the prior six months, only those procedures which are medically indicated by the current circumstances need be repeated. Where the findings reveal a condition requiring treatment, the responsible staff physician shall make a determination as to whetber the condition resulted from a cause other than the specified exposure. In making this determination, the physician should consider that the following types of conditions are not ordinarily considered to be due to such exposure: .') a. Congenital or developmental conditions, e.g., spina bifida; scoliosis. b. Conditions which are known to have pre-existed military service. c. Conditions resulting from trauma, e.g., deformity or limitation of motion of an extremity. d. Conditions having a specific and well established etiology, e.g., tuberculosis; gout. e. Common conditions having a well recognized clinical course, e.g., inguinal hernia; acute appendicitis. 5. On occasion, the responsible staff physician may find that a veteran requires care for one or more of the conditions listed in paragraph 4, but that the case presents complicating circumstances that make the provision of care under this authority appropriate. In such instances, the physician should seek guidance from the Chief of Staff and the Environmental Physician regarding authorization for treatment. If treatment is so authorized, the reasons will be clearly documented in the medical record, veterans who are not provided needed medical care under this circular may be furnished care if they are eligible under any other statutory authority. - ; �CIRCULAR 10-82-185 September 16, 1982 6. In the event the responsible staff physician finds that a veteran has a condition not ordinarily considered to be due to'5"the specified exposure and there are no complicating circumstances warranting the provision of care under this authority, the decision and its basis will be clearly documented in the medical record. 7. The provisions of this circular will not exclude any veteran who served in the Republic of Vietnam from being included in the VA's Agent Orange Registry Program as outlined in DM&S Circular 10-81-54, dated March 19, 1981. 8. Tfcase guidelines will be effective upon receipt. A copy of the pertinent guidelines should be made available to any veteran seeking care under this authority. 9. This circular rescinds DM&S Circular 10-81-249 dated November 18, 1981. w. j. &flCBY, JR., M.D~ Deputy Chief Medical Director DISTRIBUTION: COB: (10) only plus (101B1) 30 and (102) 300 SS (102) FLD: MA-300 each and DO, OC & OCRO-1£0_ each and RO-200 each plus 200-8 EX: Box 4A-6, Boxes 60, 54, 52-1 each & 63-5 3. �VIETNAM VETERAN TWIN STUDY »- The Vietnam Veteran Identical Twin Study involves a study of identical twin veterans where one twin served in Vietnam during the period of Herbicide Orange spraying and the twin sibling did not serve in Southeast Asia. Approximately 400 pairs of twins would be examined at the St. Louis VAMC, using a battery of psychologic, physiologic, and biochemical tests. The difference in test and measure scores within the twin pairs will be examined as function of both service in Vietnam and herbicide exposure. PROJECT MILESTONES (Twin Study) ACTIVITY TARGET DATE STATUS Organization of Planning Committee and Plans for Protocol Design January 1983 Completed Planning Committee's Initial Protocol Review for Full Study April 1983 Protocol is in Preparation Initial Review of Protocol for Twin Find February 1983 Completed Award Twin Find Contract June 1983 Pending Study Protocol Finalized September 1983 Participant Examination Begins April 1984 Examinations Completed August 1985 Study Completed February 1986 Note: Examination and study completion dates dependent upon success of Twin Find and recruitment efforts. �VIETNAM VETERAN MORTALITY STUDY In the conduct of any large scale health survey which examines the effects of chemical or other environmental agents, an essential element is an examination of mortality data including the cause and rate of death in comparable groups of individuals, A carefully designed and well executed mortality analysis of Vietnam veterans would provide answers to many questions raised by the Agent Orange exposure issue in particular and the possible health effects of service in Vietnam in general. PROJECT MILESTONES ACTIVITY TARGET DATE STATUS Protocol Development , Completed Let Contracts for Data Collection Completed Negotiate Interagency Support Agreement with GSA Completed Develop Statistical Methodology for Data Analysis December 1983 Underway Complete Collection of Data on Military Service and Cause of Death March 1984 Data Collection Underway Complete Data Analysis July 1984 Final Review November 1984 //-a- �DIOXIN/FURAN ADIPOSE TISSUE STUDY In a limited study conducted in 1979-1980, the VA found that 2,3,7,8-tetrachlorodibenzo-p-dioxin (.2,3,7, 8-TCDDl could be detected afid quantified in adipose tissue removed from Vietnamera veterans. Although there was no clear relationship between levels of 2,3,7,8-TCDD and Vietnam service, exposure to Agent Orange, or current health status, the study indicated the need for further investigation. Since 1970, the Environmental Protection Agency has been collecting human adipose tissue from a statistically representative segment of the general population to be analyzed for residues of selected pesticide-related chemicals and polychlorinated biphenyls (PCBs).. Within the bank of approximately 4,00.0 tissue specimens available for further chemical analysis there are specimens from 555 males born between 1937 and 19.52. Many of these individuals will have served in the military during the Vietnam-era and some will have served in Vietnam during the period of Agent Orange use. A retrospective study of selected chlorinated dioxins and furans will provide data on background levels of 2,3,7,8-TCDD in the U.S. male population and hopefully will determine if service in Vietnam has had an effect on the levels of TCDD in adipose tissue. The study will be conducted in three phases. In phase I the names and social security numbers of the approximately 555 males noted above will be obtained to determine military service status. Phase II will be the development of analytic methods for the determination of selected dioxins (especially the 2,3,7,8-TCDD) and furans in human adipose tissue. The method will be subjected to rigorous interlaboratory validation by an independent analytic referee, e.g., the Association of Official Analytical Chemists, Phase III will be the analysis of the adipose tissue and the preparation of a final report. Phases I and II should be completed within calendar year 1983, and the report from Phase III should be available in early 1985. PROJECT MILESTONES ACTIVITY TARGET DATE Interagency Agreement with the Environmental Protection Agency STATUS Completed Survey of EPA's National Adipose Tissue Bank for Tissues Meeting VA Selection Criteria January 1983 Completed Initiate Pilot Study February 1983 Initiated U-2> �Page 2 DIOXIN/FURAN ADIPOSE TISSUE STUDY ACTIVITY TARGET DATE STATUS Contact Hospital Patholo'gists for Social Security Number and Names of Tissue Donors April 1983 Letters Prepared for Distribution March 1983 Selected Analytical Chemists from U.S. and Canada to Meet to Review Analytical Protocol Draft April 1983 Meeting in Kansas City, Missouri on April 27, 28, 1983, to review draft from Midwest Research Institute (MRI) published March 11, 1983 Finalize Analytical Protocol for Analysis of Tissue June 1983 Develop Statisticallybased Sampling Protocol of Tissue Donors June 1983 Validation Tests for Analytic Method January 1984 Initiate Analysis of Adipose Tissue January 1984 Complete the Analysis of Adipose Tissue January 1985 Submit Study to a Scientific Journal for Publication March 1986 - �LITERATURE REVIEW UPDATE The goal of this project is the preparation of an updated comprehensive review and scientific analysis of the literature covering human studies and related biomedical research efforts on the herbicides 2, 4-D, cacodylic acid, picloram, and 2,4,5-T (and its associated dioxin contaminant) which were used as defoliants during the Vietnam War. The review will focus on the potential for adverse health effects of humans for exposure to these herbicides and related compounds, e.g., dioxins. This updated review and analysis will be based on an exhaustive search of the world's literature on this subject and will augment the previous two-volume, 1981, literature review titled Review of Literature on Herbicides, Including Pehnoxy Herbicides and Associated Dioxins. PROJECT MILESTONES ACTIVITY TARGET DATE STATUS Award of Contract April 1983 Evaluation of Proposals completed, Award Process in Progress. First Monthly Progress Report June 1983 Final Report January 1984 Submission for Review and Comment January 1984 Publish and Distribute January 1984 II-* �VA MONOGRAPH SERIES The VA Monograph Series is designed to provide useful scientific information on environmental and occupational factors that have or may have impacted the health of military personnel serving in Vietnam. The monographs will be authored by internationally recognized experts and will be a source of invaluable scientific information on selected topics to VA Environmental Physicians, researchers and other members of the scientific community. PROJECT MILESTONES ACTIVITY TARGET DATE STATUS June 1983 Underway Chloracne Selection and Appointment of Authors Completion of Draft November 1983 Publish and Distribute June 1984 Human Exposure to Phenoxy Herbicides Completion of Draft September 1983 Publish and Distribute Underway April 1984 Birth Defects, Genetic Screening and Counseling Completion of Draft September 1983 Publish and Distribute Underway April 1984 Cacodylic Acid (Agent Blue) Completion of Draft June 1983 Publish and Distribute December 1983 Underway �VIETNAM SERVICE INDICATOR IN PATIENT TREATMENT FILE (PTF) The Patient Treatment File (PTF) maintained by the Department of Medicine and Surgery has great potential for epidemiologic research related to Vietnam veterans. A major problem with this file is that at present there is no automated capacity to identify Vietnam era veterans who actually served in Vietnam. The establishment of such an indicator, in most instances, would require a hand search of the individual veteran's service record, PROJECT MILESTONES ACTIVITY TARGET DATE STATUS Let Contract Completed Interagency Agreement with GSA Completed Complete Collection of Data on Vietnam Service August 1983 Final Report December 1983 Underway �" VA SPECIALLY SOLICITED RESEARCH PROJECTS Research and Development Letter IL-15-81-12, August 13, 1981 solicited Veterans Administration scientists to submit research proposals on the biochemical, physiological, or toxicological aspects of herbicide and TCDD exposure. In keeping with the recommendations in the first chapter of the 1981 VA Literature Review on Herbicides, the emphasis for the proposed research studies will focus on mechanisms of toxicity and delayed effects of exposure to herbicides and TCDD. These solicited projects will provide data important to the conduct of the Epidemiologic Study. PROJECT MILESTONES METHOD OF ACCOMPLISHMENT ESTIMATED COMPLETION DATE Selection of Research Projects Merit Review Panel July 1982 1983 Funding of Projects Research Service August 1982 ACTIVITY ' One 2-year Project 1984 Six 3-year Projects 1985 One 4-year Project 1986 Two 5-year Projects 1987 �' MONTHLY STATUS REPORT OF AGENT ORANGE ACTIVITIES FOR MARCH 1983 Prepared by: Agent Orange Projects Office (10A7) Department of Medicine and Surgery Veterans Administration Central Office Washington, O.C. 20420 �Agent Orange Registry A revised Agent Orange Registry code sheet was distributed to all VA health -care facilities in March 1983. The revised registry code sheet will assist the Veterans Administration in obtaining and computerizing data dJtained as a result of Agent Orange-related examinations provided within the Agent Orange Registry program of physical examinations. The new code sheet will serve to obtain the veteran participant's name, address, sex, specific diagnosis for the veterans' health problems and other related information. This information was not obtained in a computerized form previously. It is anticipated that the new registry code sheet will greatly facilitate the information gathering/coding process. As of January 31, 1983, the Veterans Administration computerized Agent Orange Registry data base indicates that 106,149 Vietnam veterans have received an initial registry examination. The data base also reveals that 24,544 veterans have received a follow-up examination since the initiation of the registry in Nay 1978. During the month of January 1983, 2,231 veterans reported for an initial ("first-time") examination and 747 veterans reported for a follow-up examination during that same period. During this same month, 940 veterans who were scheduled for the examination failed to keep their appointments. Chloracne Monograph In addition to three other monographs currently being prepared by consultants on behalf of the Veterans Administration (Agent Blue; Birth Defects, Genetic Screening and Counselling; Human Exposure to Herbicides), a monograph on the skin condition chloracne has been initiated. Dr. Donald L. Birmingham, Clinical Professor of Dermatology, Wayne State Health Center, Detroit, Michigan, has agreed to serve as senior editor for the monograph. The ultimate preparation of the chloracne monograph will involve seven other authors and will encompass major aspects of the subject of chloracne. This monograph, like the other three monographs now underway, is designed to provide useful scientific information on environmental factors that may have affected the health of military personnel who -served in Vietnam. The four monographs will be widely distributed, when completed, to professional health care staff located at major VA health care facilities throughout the nation. It is anticipated that the chloracne monograph and the other three monographs will be published and available for distribution in late 1984. �Vietnam Experience Twin Study (VETS) DuringJanuary 1983, the Vietnam Experience Twin Study (VETS) was placed into the Veterans Administration's (VA) Cooperative Studies Program. This action will enhance the conduct of the study, assuring the full support and assistance of the VA research community. The proposed study will eventually involve some 400-450 identical twin veterans where one twin served in Vietnam during the period of herbicide orange spraying and the other did not serve in Southeast Asia. Additionally, the study will encompass the question of whether the current psychological and physical health of Vietnam veterans was adversely affected by the Vietnam Experience. The twin study will include a pilot effort to validate the proposed physical and psychological tests and measures on a series of identical and fraternal twins who will not be a part of the main study. It is anticipated that a satisfactory protocol will be finalized by October 1983. Chloracne Task Force Activities At a VA Herbicide Advisory Committee meeting in late 1982, a member of VA's newly reorganized Chloracne Task Force recommended a major effort to locate Vietnam veterans who may be suffering from chloracne a skin disease believed caused by exposure to dioxin, a contaminant found in Agent Orange. Dr. A. Betty Fischmann, chairpersonof the Task Force, said that the major focus of the Task Force is to resolve the chloracne health-care issue in the near future. The reorganized Task Force, which consists of five members and a program analyst based at the Washington, D.C., VA Medical Center, held its first meeting in December 1982 during the annual neeting of the American Academy of Dermatology. Dr. Fischmann reported on the status of Task Force activities at VA's Herbicide Advisory Committee meeting in February 1983. In this regard, Dr. Fischmann stated that the Task Force has: * Organized a nationwide network of dermatological consultants; " Developed a standard questionnaire for dermatologic Agent Orange examinations, which is now being reviewed; * Developed criteria for diagnosing chloracne, vAiich also are being reviewed; and * Organized special examinations at private clinics for veterans with possible cases of chloracne. -3 �The chloracne examinations at private clinics had been completed by January 1983. Of the 3,200 claims filed by Vietnam veterans for disability condensation for skin conditions, 13 of the 14 possible chloracne cases have been examined. One vfteran has not been located. Of the 13 veterans examined, 11 were found to have acne but none could be diagnosed as chloracne. One man may have had chloracne in Vietnam and another had an increase in acne when he., worked as a civilian with halogenated hydrocarbons. The Task Force also has completed a pilot analysis of Agent Orange examinations at the Washington VA Medical Center to identify dermatologic diseases that might be chloracne. The Task Force has proposed an ongoing review of current Agent Orange Registry examinations. The Task Force also serves as a resource in the development of a monograph on chloracne. Soft-Tissue Sarcomas VA's Agent Orange Projects Office is now in the process of researching data on the number of Vietnam-era veterans who have been diagnosed as having soft-tissue sarcomas (malignant tumors). The VA's Data Processing Center in Austin and the patient treatment records have provided a count and a list of names of veterans who were diagnosed as having such sarcomas. Several epidemiological studies conducted by Swedish scientists report evidence of a relationship between soft-tissue sarcomas and exposure to phenoxy herbicides. Similar studies in Mew Zealand and Finland, however, show no such relationship. The Swedish studies consisted of two investigations by the same investigators. The first involved 52 soft-tissue sarcoma patients who were matched with 208 controls without such tumors. Results indicated a five-fold increase in the risk of soft-tissue sarcomas in those workers exposed to phenoxy herbicides. In the second study, using the same technique as the first, 110 patients with soft-tissue sarcomas and 219 controls were matched. Forestry and agricultural workers had a risk five-times greater than that of the other workers. New Zealand scientists conducted a study involving 102 males with softtissue sarcomas who appeared on the New Zealand Cancer Registry between 1976 and 1980 and 306 controls chosen from patients with other forms of cancer. The two groups were matched by age, year and occupation when added to the Cancer Registry. In spite of the fact that phenoxy herbicides have been used extensively for many years in New Zealand in agriculture and forestry, the study findings do not show an excess of softtissue sarcomas for workers involved in these occupations. �In Finland, mortality data on 1,926 workers involved in dioxincontained-herbicide spraying during 1955-1971 were studied from 1972 to 1980. although exposure was rather low and of a short duration (but similar to that reported in the Swedish studies), no cases of death from soft-tissue sarcomas were found. Mortality figures (including deaths from natural causes and from all types of cancers) also were studied separately for subgroups of workers who were more heavily exposed. Results did not show an increased mortality rate for these workers. Mortality Studies The Veterans Administration Mortality Studies, initiated in mid 1982, are designed to analyze and compare death rates and cause-of-death of profiles between veterans with service in Vietnam and comparable veterans with no service in Vietnam. The studies use existing YA computer records (BIRLS) to identify a group of approximately 60,000 deceased veterans. Cause-of-death data will be obtained from death certificates and histories of military service will be obtained from military records. As part of the mortality studies, an independent validation of BIRLS will be undertaken by the National Academy of Sciences. As of November 10, 1982, WESTAT has been under contract to abstract tly Military Personnel Records (MPR). An Interagency Agreement (IGA) with the General Services Administration (GSA) was formalized on January 4, 1983, to locate and pull MPRs and provide them to WESTAT for des (such abstraction. An agreement was reached with the Department of Veterans Benefits to provide working space for WESTAT personnel at the Military Personnel Center, St. Louis. In early March WESTAT provided a draft report of a pilot study based upon a sampling of 200 cases reviewed to date. Moschmann Associates Inc. , received a contract in December 1982, for the coding of death certificates. In conjunction with this action, another IGA was initiated. A pilot study of coding has been initiated involving about 2,000 of these records, all. Thus, the gathering of data for the Mortality Studies is well underway and completion of data collection is anticipated by March 1984. The results should be published in a report by December 1984. Approximately $1.13 million have been allocated by the Department of Medicine and Surgery for these studies. Dioxin Literature A new book has been released by Plenum on "Human and Environmental Risks of the Chlorinated Dioxins and Related Compounds.11 Dr. Alvin L. Young of the Agent Orange Projects Office is a co-editor. The book is a compilation of the 53 original manuscripts and the Blue Ribbon Panel Reports of the 2nd International Symposium on Chlorinated Dioxins and Related Compounds held October 25-29, 1981 in Arlington, Virginia. The book is organized into the following sections: A Definition of the Problem, Analytical Chemistry, Environmental Chemistry, Environmental Toxicology, Biochemistry and Metabolism, Environmental Toxicology, Human Observations, Risk Assessment, Laboratory Safety and Waste Management, and Panel Reports. �This volume will be invaluable to scientists/ public health agencies, natural resources managers, and others concerned with the presence of dioxins in the environment. The book may be obtained from: »P Plenum Publishing Corporation 233 Spring Street New York, New York 10013 " Price: $95.00 " Retrospective Study of Dioxins and Furans in Adipose Tissue The Adipose Tissue Study is designed to provide analytical data on the levels of dioxins (especially the 2,3,7,8-TCDD) on the United States Vietnam Era-aged male population. Additionally, it may determine whether service in the military and especially Vietnam has had an effect on the levels of TCDD in adipose tissue. A draft of the analytical method for the study will be discussed and reviewed by authorities meeting in Kansas City, Missouri, on April 27-28, 1983. Based upon comments received, the draft will be revised for further review prior to finalization of the methodology. Twenty-nine representatives of the scientific community (government, academic and private sector) are expected to attend the meeting. It is felt that this approach will insure the development of a valid analytical method. Analyses of tissues should begin in January 1984 and a report prepared for distribution in early 1985. Literature Review A project has been initiated within the Agent Orange Projects Office (AOPO) to prepare an updated comprehensive review and scientific analysis of the literature covering human studies and directly related biomedical subjects. The review will be based on an exhaustive compilation of the world's literature on the subject and will update the previous two-volume set entitled "Review of Literature on Herbicides, Including Phenoxy Herbicides and Associated Dioxins" which was published in 1981. The literature update and assessment will be useful to a broad audience and illustrates the VA's continued efforts to provide Congress and all concerned with the most current information available dealing with the question of Agent Orange and dioxins. The review is expected to be published in January 1984. �Australia Releases Two Reports on Australian Vietnam Vets Two reports on Australian forces who served in Vietnam have been issued. The first examines the possible effects of pesticides on their health and the second covers whether they are at an increased risk of having children and birth defects. AftegFevaluating evidence and reviewing claims made by the Vietnam Veterans Association of Australia, the Australian Senate's Standing Committee on Science and the Environment released its first report on the possible effects of pesticides on Australian Vietnam veterans. The committee reached these conclusions: * It is unlikely that the majority of* Australian troops were directly or indirectly exposed to herbicides used by U.S. forces, namely Agent Orange and other compounds containing the phenoxy herbicides, 2,4-D and 2,4,5-T. However, direct exposure to insecticides (such as malathion) used to control malaria was probable in the majority of cases. * It is accepted that all Vietnam veterans would have been exposed to harmful chemicals outside of Vietnam. The report suggests that the additional burden of exposure to potential cancer-causing substances associated with a one-year-period of service in Vietnam is likely to have been relatively small. * * There is no convincing evidence, at present, that the rates of birth abnormalities, psychiatric disorders and mortality are excessive among Vietnam veterans. The committee does not rule out the possibility that excessive rates may appear in the future. " There is insufficient evidence to support allegations that there is an increased mortality rate among Vietnam veterans because of cancer. Other causes of death (suicides and accidents resulting from psychiatric disorders) in Vietnam veterans may be excessive and, therefore, may justify further monitoring. In a separate study, a team from the Conroonwealth Institute of Health, University of Sydney, attempted to determine whether Vietnam-era Australian veterans were at an increased risk of fathering a malformed child. In February 1983, the Australian government issued a report on the results of this study entitled "Case-Control Study of Congenital Anomalies and Vietnam Service (Birth Defects Study)." It is the first scientific study on the subject ever completed. The study found that Australian veterans of the Vietnam conflict were not at increased risk of fathering a malformed child. A2-7 �Three groups were included in the study: Vietnam veterans, contemporary Army personnel who did not serve in Vietnam and community members who did not serve in the Army at that time. The analysis also showed that the risk of fathering a malformed child was no higher for either Vietnam veteran or Army non-Vietnam.-veteran fathers than for other Australian males and the risk was not different for National Service and Australian Regular Army Vietnam veterans. f State Agent Orange Groups Hold First National Meeting Seventeen states have begun their own programs relating to the Agent Orange issue. VA's Agent Orange Projects Office maintains an ongoing relationship with each state program, providing Agent Orange informational materials and other assistance. Representatives from seven of the official state Agent Orange programs held the first national meeting on Agent Orange in the fall of 1982. Representatives agreed to share medical, scientific and outreach information to promote action on resolving the Agent Orange issue. Representatives also attended the VA Advisory Committee on Health-Related Effects of Herbicides in February 1983 and a special meeting with Administrator Harry Walters. �Veterans Administration Department of Medicine and Surgery Circular 10-83-38 Washington, D.C. 20420 March 1, 1983 TO: •£• Regional Directors; Directors, VA Medical Center Activities, Domiciliary, Outpatient Clinics, and Regional Offices with Outpatient Clinics (136) SUBJ: Possible Exposure of Veterans to Herbicides During the Vietnam War, RCS 11-49 \' 1. This represents a revision of Circular 10-81-54, dated March 19, 1981. The following circular is referenced: 10-82-37 dated March 15, 1982. 2. The issue of Agent Orange continues to be a genuine concern to a large number of veterans, the scientific community and the chemical industry, and as a result, continues to receive extensive media attention. The VA remains in the forefront of this issue and continues to play a leading role in supporting scientific and educational initiatives in an effort to provide. all concerned veterans with the information and guidance they need, as well as any medical care for which they are eligible. 3. The Agent Orange Projects Office (10A7) has the responsibility to coordinate and monitor all DM&S activities relating to the Agent Orange issue including the registry. All policy and clinical questions relating to the potential effects of herbicides should be referred to this office (FTS: 389-5412). Questions relating to eligibility of veterans or treatment of active duty personnel should be referred to Medical Administration Service (136) VACO (FTS: 389-2598/2849). 4. The maintenance of the Agent Orange Registry remains an important function of the VA and is managed centrally by the Agent Orange Projects Office (10A7). The Agent Orange Registry remains our most effective means of identifying concerned Vietnam veterans. The importance of the role of each VA employee, beginning with the initial contact, in providing physical examinations and necessary treatment and advising the . veteran of the results of the examination cannot be over-stressed. Any eligible Vietnam veteran expressing a concern relating to exposure to herbicides is encouraged to participate in the registry which includes a thorough medical examination. In addition, any eligible Vietnam veteran currently receiving treatment in VA medical centers and outpatient clinics will be identified and provided with the opportunity to participate in the Agent Orange Registry. Follow-up of the veterans entered into the registry will be conducted over a period of years in an effort to obtain further information regarding any long-term health effects resulting from these chemicals. THIS CIRCULAR EXPIRES ON FEBRUARY 29, 1984 M-l �Circular 10-83-38 March 1, 1983 5. VA Environmental Physicians play a most significant role in determining the perceptions Vietnam veterans have concerning the quality*' of VA health care services and of their individual treatment by VA health care providers. The Environmental Physician will review the records of every Vietnam veteran examined to assure that a complete physical examination was performed and documented. It is important that each veteran be fully advised of the limitations of an Agent Orange related examination, that is, what the examination can or cannot reveal as regards the presence of dicxin in the body system and/or the relationship to adverse health effects or potential health defects or illnesses which may or may not be related to a veterans exposure to Agent Orange. I wish to strongly encourage your consideration of the best way to accomplish this communication process. Die following alternatives i&Mit be considered. ( ) Provide each Vietnam veteran reporting to the Outpatient 1 Admissions area with a handout describing the purpose of the examination and its limitations. This can be further clarified by the examining physician during the course of the physical examination, preferably prior to beginning the physical examination process. ( ) Provide each veteran with the opportunity to view the 2 audiovisual "Agent Orange: A Search for Answers.11 Veterans and/or visitors to VA health care facilities should be informed concerning the film and when and where it can be viewed. ( ) Make all Agent Orange pamphlets and other informational 3 materials available to Vietnam veterans and the public - keeping them displayed in prominent areas and ensuring that sufficient copies are available for distribution. It should be standard operating procedure to provide copies of VA Agent Orange pamphlets to all telephone callers requesting Agent Orange information. 6. It is essential that a complete medical history and physical examination be performed and documented. The medical history should be documented on SF 50 4 and SF 505 and the physical examination should be documented on SF 506 or VAF 10-7978e. The Agent Orange Registry code sheet (VAF 10-9009) does not replace any medical record. In eliciting the medical history and performing the physical examination (which should be conducted by/or under the direct supervision of the Environmental Physician), special attention will be given to those organ systems alleged to be roost frequently �Circular 10-83-38 March 1, 1983 affected by exposure to herbicides containing TCDD. These include the" liver, kidneys, skin and the reproductive, endocrine, inraunologic and nervous systems. Particular attention will be paid to the detection of chloracne, a skin condition which has been associated with acute exposure to TCDD and other dioxins. Evidence will also be sought concerning the following potentially relevant symptoms or conditions: altered sex drive; sterility; congenital deformities among children; repeated infections; neoplasia; and for female veterans, difficulties in carrying pregnancies to term. In gathering these data, it is important to determine and record the time of onset of the symptoms or conditions; their intensity; the degree of physical incapacitation; and the details of any treatment received. The person actually performing the physical exam should be identified with the signature and title (M.D., P.A., etc.). If the examiner is other than a physician, a physician's counter-signature is required, preferably the Environmental Physician. When an Agent Orange examination is done as part of a compensation and pension examination, the physical examination will be done by/or under the direct supervision of the Environmental Physician. 7. All veterans participating in the Agent Orange Registry will be given the following baseline laboratory studies: complete blood count, urinalysis, SMA-6, EMA-12, and a chest x-ray if one has not been done within the past 6 months. Appropriate additional diagnostic studies should be performed and consultations obtained as indicated by the patient's symptoms and physical and laboratory findings. Non-routine diagnostic studies, such as sperm counts, should be performed only if medically indicated. 8. One Environmental Physician will personally discuss with each veteran examined the results of the examination and the laboratory studies which are available at the time the physical examination is completed. This personal interview will be conducted in such a way as to encourage the veteran to discuss his/her own health concerns as well as those of his /her family as they relate to exposure to herbicides. In the absence of the Environmental Physician, the interview will be provided by a designated physician familiar with the Agent Orange program. The interviewing physician will document this action in a progress note in the veteran's medical record. In addition to the personal interview, a follow-up letter will be sent to each veteran explaining the results of the examination and laboratory studies. A copy of this letter will be filed in the veteran's administrative medical record. Recommended sample letters are provided in attachments A and B. �Circular 10-83-38 March 1, 1983 9. Particular attention is directed to the Special Registry at the Anted Forces Institute of Pathology (see DM&S Circular, dated 10-82-37 March 15, 1982). All pathological material (autopsy, surgical, cytologic, or other similar tissue) obtained from any Vietnam veteran will be processed in accordance with DM&S Circular 10-82-37 for inclusion in this special registry. 10. It has been determined that the analytical technology for measuring minute levels (parts per trillion) of TCDD in human fat does exist. The results of this study, however, are inconclusive as regards exposure to herbicides in Vietnam. Therefore, no VA medical center will perform any surgical or other procedure for the purpose of obtaining tissue for measuring TCDD in patients without prior approval by VAOO (10A7). 11. When a Vietnam veteran requests an Agent Orange examination at a VA medical center, the center's Medical Administration Service will be notified and will initiate the procedures listed below: a. Prepare a 3x5 card with the following typewritten information: (1) Veteran's full name (2) Veteran's address and telephone number (3) Date of birth (4) Social Security Number (5) Date of initial examination (6) Dates of follow-up examinations b. The card will be filed alphabetically in a special file, labeled "Agent Orange Registry." This registry card will be maintained until further notice. Every effort should be made to maintain the veteran's current address and telephone number. •c. VA Form 10-10M contains a statement regarding "Possible Exposure." This item should be completed for ail veterans applying for the Agent Orange examination. 12. The original records of all examinations performed on Vietnam veterans for possible herbicide toxicity are to be retained in the veteran's Consolidated Health Record (CHR). If a CHR does not already exist for a veteran examined for herbicide toxicity, one will be established, and the results of the examination for herbicide toxicity is to be enclosed in the CHR. A locator card will be created with the establishment of CHR. 13. The following procedures pertain to active duty personnel according to the site of the Agent Orange examination: a. When active duty members of the uniformed services apply to VA facilities for an Agent Orange examination, the requirements of M-1, Part 1, Chapter 15 regarding the authorization from the �Circular 10-83-38 March 1, 1983 appropriate branch cf service and the billing of the appropriate branch cf service will apply. The procedures of establishing a 3x5 card, of processing and completing the code sheet for active duty personnel will be the same as those followed for a veteran participating in the Agent Orange registry. b. However, a military facility may perform the Agent Orange examination according to VA instructions. Military facilities have been informed to obtain a copy of the pertinent VA directive and samples of appropriate forms fron the nearest VA facility. The completed physical examination/ laboratory tests, and questionnaire will be forwarded to the nearest VA medical center or outpatient clinic. Per these individuals the Medical Administration Service personnel at the medical center will: (1) Prepare a colored 3x5 card with similar data as prepared for a veteran clearly label card as "Active Duty." Insert card in Agent Orange Registry file. (2) Abstract the data from the medical record documents to the code sheet. (3) Submit original code sheet to the VA Data Processing Center, Austin, TX as indicated in paragraph 18. (4) Forward copies of the medical record documents with a copy of the code sheet to VA Central Office (10A7A). (5) Place the original medical record documents in a plain folder properly identified with the name and social security number and a notation "Active Duty Agent Orange Exam at military facility." These folders should be maintained in a special location in the file room. (6) While the medical documents are not placed in the CHR (Type I or II folders), these special folders are subject to the same retention and disposition policies of the CHR. (7) If an active-duty military person becomes discharged and reports for treatment as a veteran, the Agent Orange examination will be filed in the CHR. 14. There is a high priority concern for prompt handling and scheduling Agent Orange examinations. Facilities should make every effort not to have 50 or more Agent Orange examinations pending at the end of the month. Facilities having 50 or more examinations pending will be contacted by Agent Orange Projects Office Staff to ascertain the plan of action to be implemented in reducing the backlog and to determine how many examinations are pending beyond 30 days. //-r �Circular 10-83-38 March 1, 1983 15. ^A monthly submission of medical record documents and code sheets will be sent to VACO, Agent Orange Projects Office (10A7A, Pm B-67) according to the mailing schedule listed in paragraph 17. The monthly submission will contain the following: a. One legible copy of all the medical record documents relating to the Agent Orange examination. These documents should be placed in alphabetical order with the code sheets stapled on top of the medical record documentation for submission to 10A7A. Pertinent laboratory data and consultations obtained as part of these examinations will be held pending arrival of these data. Only copies of completed examinations stvxild be submitt b. Fallow-up examinations will be reported in the same manner. c. The Agent Orange Registry Code Sheet (VAF 10-9009) will be prepared in three copies. One copy will be filed in the veteran's CHR with the documentation from the Agent Orange examination. One copy will be stapled to the corresponding medical record documents that are sent to VACO (10A7A). The original code sheet will be sent to the Austin Data Processing Center in (DPC). See paragraph 18 for instructions for mailing the code sheets to the DPC. 16. Instructions for completing the code sheets (VAF 10-9009) are listed in Attachment C. Effective with the issuance of this circular, the new code sheets (VAF 10-9009) must now be used. The Agent Orange Registry code sheet has been revised. DO NOT USE the VAF 10-9009 with November 1980 and September 1981 dates, tEey will no longer be accepted. The VAF 10-9009 with the 1982 date will be used. Old stocks of 1980 and 1981 VAF 10-9009 may be destroyed. The VAF 10-20681 (NR) Initial Data Base will no longer be used. 17. The following mailing schedule should be used for mailing the monthly submission to VACO (10A7A) and the Austin DPC. Region Number 1 2 3 4 5 6 Mailing Date 6th of Month 10th of Month 14th of Month 18th of Month 22nd of Month 26th of Month �Circular 10-83-38 March 1, 1983 18. ttie following instructions should be followed for the making of the original code sheet (VAF 10-9009) to the DPC, These code sheets will be nailed monthly. Code sheets must be received at the DPC according to the mailing schedule listed in paragraph 17. a. Batching of input documents; (1) Code sheets should be scanned to ensure all required fields have been completed. (2) Completed code sheets will be batched in groups of no more than 25 code sheets. Each batch will include code sheets for only one facility as indicated by identical entries in all six positions of the code sheet field one. Different facilities must be batched separately (i.e. VAMC one batch, OPC one batch). Batches of less than 25 code sheets are acceptable. (3) Attach a transmittal form to each batch of documents. Record the six position facility number and the number of documents on the transmittal. (4) Using the batch control log (see 18c below) assign the next sequential batch number and record it on the transmittal form. NOTE; Begin batching with batch number 001 in January of each year arxT continue with_ sequential numbers throughout the year. (5) Code sheets should be stapled together in the upper left-hand corner. No medical record documentation should be attached to these code sheets. (6) Corrected code sheets do not have to be batched separately or handled separately. They can be mailed with the regular code sheets as long as they are for the same facility number. b. Transmittal form: (1) IWp copies of VA Form 30-7252, "Transmittal Form for the Use in Shipment of Tabulating Data," will accompany each batch of code sheets. One copy will be retained at �Circular 10-83-38 March 1, 1983 the Austin DPC and the other copy will be returned to the transmitting facility with the code sheets and edit analysis lists prepared at the DPC. (2) The transmittal form will be completed as follows t Item 2: Name and address of transmitting facility Item 3: Facility number of transmitting facility and correspondence symbol Item 6: Date of dispatch Item 7: Maine and telephone number (FTS) of responsible individual at facility Item 8: Facility Number; The three (3) to six (6) position FTP facility number used on the code sheets of this batch (code sheet field II) Batch number; The batch number assigned by the transmitting facility (see below —control log). e Code Sheet Count • ^ number of code sheets in this batch (2$ or less). (3) The following is an exanple of the completed transmittal form. TRANSMITTAL FORM FOR USE IN SHIPMENT OF TABULATING DATA I 'VA. Medical Center "V f VA Data. Processing Center (200/392A) A \ f 1615 East Woodward Street 1 50 Irving Street, N.W. 20422 ) Austin, TX. 78772 1 Washington, D.C. 4. EFFECTIVE DATE OF DATA J J. REPLYJ^fS««. no./mymbol) L ATIH: Agent Orange Clerk 1688/136B1 B. DISPATCH DATE S. NO. OF PACKAGES CA. FINAL 7. OFFICIAL RESPONSIBLE FOR SHIPMENT flV«m«, Mil. and •ffiulun) BATCH fCh«cl» Jane Smith 389-5412 8. TABULATING DATA REPORTS CONTROL SYMBOL nr 1 <C» 20A1 AGENT ORANGE Facility number Batch number Code sheet count t. REMARKS , FORM 8 30-7252 HO. OF COPIES CARD COUNT OF REPORTS (D) (E) DESCRIPTION JOB NUMBER EXISTING STOCK OF VA FORM SO-72S2. MAR tM6. WILL BE USED. 688 002 025 �CIRCULAR 10-83-38 March I, 1983 j(4) The encircled area en the copy of the transmittal sheet (the address of the DPC, address of the transmitting facility, station number, and mail symbol, job number, "Agent Orange," facility number, batch number, and code sheet count) should be overprinted on the VA. Form 30-7252 at each facility. The facility number entered has to be the FTP or OPC number that is coded on the code sheet. c. Control log: As batches are prepared for submission to the DPC an entry should be made on the control log. Instructions for the use of the control log and an example of the control log follows: FACILITY (1) AGENT ORANGE CONTROL LOG (2) (3) (4) (5) Batch 1 Code Date Date Number Sheets Sent Returned 002 25 10-6-81 10-26-81 (1) An Agent Orange address control log should be maintained for each facility (Facility Code Number). (2) The batch number will be assigned sequentially by facility. The batch number will be recorded on the log and on the transmittal sheet (Item 8). (3) The number of code sheets in the batch will be recorded on the log and on the transmittal sheet (Item 8). (4) Date the batch was mailed to the DPC. (5) Date the batch and associated edit output was returned from the DPC. �Circular 10-83-38 March 1, 1983 d. Mailing; (?) The facilities will establish their own control over the mailing of code sheets to the DPC. In order to ensure that the computer files are current, each facility should submit input at least once each month. (2) The mailing address for the DPC is: VA DATA PROCESSING CENTER (200/392A) 1615 East Woodward Street Austin, TX 78772 .ATTN: AGENT ORAN3E CLERK (3) Contact the Agent Orange Clerk at the DPC regarding questions about submitting code sheets, batch control, etc., The telephone number is ITS 770-7281. It is not appropriate to call the DPC in regard to questions on code sheet completion or correction of rejections. These questions should be referred to Nancy Howard, VACO, PTS 389-5412. e. Processing: (1) The DPC will keypunch the data from the code sheets and the records twice each month (10th and 25th). Subsequent to editing, the DPC will return all batches and the edit lists to the transmitting facility. (2) While all code sheets will be returned to the transmitting facility, computer listings will reflect only rejected records. For correction of the rejected records, refer to the coding instructions in Attachment C. There will be no published edit list of how to correct errors; carefully following the instructions and double checking the information coded is absolutely essential1 Corrections are to be made on the returned code sheet with RED pen or RED felt-tipped pen or a new code sheet can be made with the corrections in the appropriate field(s). If a new code sheet is prepared for the return of a correction, do not just complete the corrected field(s)—all of the fields must be completed as if it were an initial input. DO NOT leave any blank fields. (3) All returned code sheets should be disposed of only after all information input is verified as correct. Refer to the RCS 10-1 schedule under Medical Administration Service section for the disposition schedule. 10 if- �Circular 10-83-38 March 1, 1983 (4) There has keen a programming change in the editing process for the Agent Orange Registry. Several new error messages are apgparing. Examples of the new messages and the corrective action needed are listed below: (a) ****** - means an error is in a field. ACTION - correct error and resubmit. (b) Duplicate Initial Exam - means there already appears on the file an initial Agent Orange examination for this veteran. It may be for the same reporting facility or a different VA facility. ACTION - No action is necessary. (c) Warning - No Initial Exam - means the file does not contain an Initial Exam record for this veteran, but the registry has accepted the follow-up record that was previously submitted. ACTION - Reconstruct the initial exam record and submit to the DPC. DO NOT resufamit the follow-up exam. 19. A monthly statistical report will be sent to VAOO, Agent Orange Projects Office, Attn: Nancy L. Howard, ERA (10A7A, Rm, 848). Do not enclose this letter with the medical record documentation and cede sheets sent to 10A7, Fm. B-67. This statistical report will be prepared on a monthly basis and should arrive in VAOO (10A7) by the tenth workday following the end of the month. Negative reports are required1." Please assure that accurate statistics are reported. For Satellite OPC's performing Agent Orange examinations do not submit the statistical report separately, The totals should""Ee combined with the parent facility totals. Do not use the mailing schedule described in paragraph 17 for submission of this statistical report. This transmittal letter should contain: a. The number of initial examinations performed during the month; b. The cumulative total of initial examinations performed; Ct The number of follow-up examinations performed during the month. d. The cumulative total of follow-up examinations performed; e. The number of initial examinations pending beyond the end of the month; f. The number of veterans failing to keep an initial examination appointment. H-ll 11 �Circular 10-83- 38 March 1, 1983 See definitions in Attachment D for an explanation of the monthly report terminology'. A copy of the format for the statistical report is illustrated in Attachment E. It should be noted that the pending examination total (e) and the number of veterans failing to keep an initial examination appointment (f) are not cumulative totals. These apply to the report month only. 20. Special care should be addressed to the completion of the examination code sheets. A black ball-point pen or a black felt-tipped pen should be used. No pencils or blue ink pens should be used as these markings do not reproduce clearly. Carefully follow the instructions for completing the code sheets to assure that all data fields are completed. It is recommended that the Chief, Medical Information Section, be given the responsibility for the coding, completing, mailing of the code sheets to the DPC and the correcting of the code sheets to assure all areas are completed accurately. 21. This circular rescinds DM&S circulars: 10-80-203, dated September 12, 1980; 10-81-12, dated January 15, 1981; 10-81-54, dated March 19, 1981; 10-81-82, dated April 28, 1981; 10-81-115, dated June 4, 1981; 10-81-263, dated December 1, 1981; 10-82-5, dated January 18, 1982; and 10-82-110, dated June 28, 1982. W. J. £A00BY, JR., M.tf Deputy Chief Medical Director DISTRIBUTION: COB: (10) only plus (10A7) 500 SS (10A7) FLD: MA-5 each and RD, DO, OC & OCRO-2 each plus 200-8 EX: Box 44-6, Boxes 60, 54, 52-1 ea. & 63-5 /V-/2- �ATTACHMENT A Circular 10-83-38 March 1, 198" (FACILITY LETTERHEAD) """ Positive Findings — Recommended Format Dear Veterans We sincerely appreciate your recent participation in the Veterans Administration's Agent Orange Registry. This effort should prove to be very helpful in assisting us to better serve veterans, such as yourself, who are concerned about the possible adverse health effects of exposure to Agent Orange. A review of the results of your examination indicates that (Use this space to briefly describe any positive findings.) In view of the above findings, we suggest that you contact the Outpatient Admissions Office at extension ___^^.___ to schedule a follow-up examination. This will provide us with an opportunity to personally discuss these findings with you and to suggest or provide any essential medical treatment. Again, your participation in the registry is appreciated. Sincerely, (NAME) Environmental Physician A-l �ATTACHMENT B Circular 10-83-38 March 1, 1983 (FACILITY LETTERHEAD; Negative Findings — Recommended Format Dear Veteran: We sincerely appreciate your recent participation in the Veterans Administration's Agent Orange Registry. This effort should prove to be very helpful in assisting us to better serve you and your fellow veterans who are concerned about the possible adverse health effects of exposure to Agent Orange. The results of your examination and laboratory tests suggest that you are presently in good health and that you have no reason at this time to be concerned about possible adverse health effects resulting from exposure to Agent Orange. However, if in the future you have a medical condition about which you are concerned, I would encourage you to seek the help and advice of your nearest Veterans Administration Medical Center. The results of your examination will be maintained by the Veterans Administration and will be available for future use as needed. Again, your participation in the registry is appreciated. Sincerely, (NAME) Environmental Physician B-l �CIRCULAR 10-83-38 .March 1, 1983 Attachment C INSTRUCTIONS FOR ITEMS 1-20 for the Agent Orange Registry Codesheet. (VAF 10-9009). Item 1 - Facility Number - Suffix - Enter FTP facility code. Use the AMIS Suffix (BY, BZ etc) to indicate your satellite facility. DO NOT USE Q,R,S, Item 2 -> Tfeteran's Name Beginning in block 8, enter veteran's last name (please print) using one letter per block.Apostrophes and hyphens in the name should not be used and empty blocks must not be left between the letters of the last name. Do not skip a space or use a comma if the last name is followed with JR, SR, I, II or III, etc. Beginning in block 34, print the first name, one letter per block. If there is a middle name, enter the middle name beginning in block 49 otherwise leave this block blank. Item 5 - Type of Exam - Enter A « initial; C « follow-qp. To delete an entire! initial examination with a noted error after it has been accepted Into the registry, resubmit the original code sheet with a "B" coded in block 59 and submit a code sheet with the correct information with an "A coded in block 59. All fields roust be completed on a resubmissicn. The code sheets can be shipped in the same batch. An example for this usage will be for incorrect spelling of the name, incorrect social security number, changing of address etc. To delete an entire follow-up examination with a noted error after it has been accepted Into the registry, resubmit the original code sheet with a "D" coded in block 59 and submit a code sheet with the correct information with a "C" coded in block 59. Item 6 - Social Security Number Block 60 should be left blank. Enter the SSN in blocks 61 through 69. If the veteran does not have a social security number, place the letter "P" in block 60 and assign a pseudo SSN. (See FTP instructions for pseudo SSN). Numerical zeros must be slashed ( ) 0. Item 7 — Service Serial Number Enter the Service Serial Number beginning in block 70, unused blocks remain blank. Numerical zeros must be slashed ( ) 0. If the serial number begins with US, blocks 72-79 must contain a number(s). Pill unused block(s) with zero(s) for this instance only. If the serial number is unknown, enter a U in block 70. Unused blocks remain blank. C-l �Circular 10-83- 38 March 1, 1983 Example: 7(J "1 u & V(S 7JJ 1i 7J 74 7b 76 7v fa Vy 7 9 8 0 0 Service Serial*Number 708000 T! 74 74J 71 6 6 3 76 77 78 7i 0 0 0 0 Service Serial Number: US 66700000 70 71 72 73 74 75 76 77 76 74 U Veteran does not know serial number Item 8 - Date of Birth ' Enter the numerical equivalent for the month (blocks 80-81) and day (blocks 82-83). Enter the last two digits of the year of birth in blocks 84 and 85. Numerical zeros must be slashed ( ) 0. Example: MO. "81! 81 0 DAY | YR. 82 83 84 85 5 t 9 4 7 May 9, 1947 Item 9 - Current Address Print the veteran's current address in the spaces provided. Use of one block per letter or number. Leave one blank spaoe between street number and name. Print street address in blocks 86-111. Print city or town in blocks 112-137. Print zip code in blocks 138-142. Blocks 143-146 will be blank. Using the PTF codes, assign the proper country and state codes in block 147-151. Item 10 - Race/ Ethnicity Enter the appropriate code in block 152. Item 11-13 «• Sex, MartialL Status^js. Current Status of Veteran Enter appropriate codes. Item 14 _- Branch of: Service Enter appropriate codes in block 156. C-2 If veteran was in more than one branch of service (item 14), code the latest Vietnam service. �Circular 10-83-38 March 1, 1983 Item 15 -.Jhter the appropriate code for Vietnam service in block 157. If the veteran did not serve in Vietnam, blocks 158-173 should be left blank. Item 15A - Code the numerical equivalent of the month and code the last two digits of the year of last period of service in Vietnam. Numerical zeros must be slashed ( ) 0. Item 15B - If veteran had two or more periods of service in Vietnam, the next to last period of service should be coded in the blocks provided.If only one period of service in Vietnam code this in 17(a) and leave 17(b) blank. Numerical zeros must be slashed (J0). Item 16 - Corps or Area Served Enter the appropriate code (in block 174) for the corps or area in which veteran served. If he served in more than one, use code 6. Item 17 - Military Unit Enter the military unit in which the veteran served. Please specify complete unabbreviated title. (Company, battalion, corps, ship, division). Item 18 - Last Two Periods of Service Code the month and year of the last two periods of service in 18(a) and (b) regardless of whether or not they were in Vietnam. If veteran did not have more than one period of service, leave (b) blank. Item 19(a) - (e) Exposure to Agent Orange Place the most appropriate code that describes veterans exposure to Agent Orange in the block provided. Do not leave any block blank. Item 20 - Veteran's Health Enter the code that most appropriately describes veterans health. C-3 �Circular 10-83-38 March 1, 1983 INSTRUCTIONS FOR ITEMS 21-34 (TOE ITEMS TO BE COMPLETED EK THE EXAMINING PHYSICIAN OR THE DESIGNATED PHYSICIAN) Item 21_ - Date of Exam Enter the numerical equivalent of the month, day, and year in the appropriate blocks. Item 22 - Veteran's Carplaint(s) Print the veteran's complaint (s) in the blanks provided. MAS personnel will fill in the blocks for 22<a), (b) and ( ) utilizing the ICD-9-CM c, ceding systems. Use the symptoms and signs categories (780-789) for this coding. The "78" has been preprinted for you. For unccdable symptoms, use 78999. For no known ccnplaints use 78000. Item 23 - Chief Conplaint Enter appropriate code (1 or 2) in the block. Item 24 - Numbei: of Complaints Enter the number of ccnplaints the veteran has in the block provided. If the veteran has 5 or more ccnplaints, enter 5 in the block. Item 25 - Evidence of Birth Defects in Veteran* s Children? Enter the appropriate code for item 25. Item 26 - Diagnostic Work-up and/or Consultation. If no work-up and no consultation has been done, enter code 1 in the blocks provided. If a work-up and/or consultation has been done, enter the appropriate code (2,3,4) in the blocks provided. All blocks must have one entry. Item 27 - Additional Wprkupg/Cpnsultat ions Specify any additional workups/consultations performed but not listed in item 26. Item 28 - Diagnosis Print the veteran's major medical diagnosis(es) in the spaces provided ( , , ) For each diagnosis listed, MAS will utilize the ICD-9-CM abc. coding system. Any diagnosis relating to a neoplasm should be documented in item 29. C-4 �Circular 10-83-38 March 1, 1983 Item 29 - Evidence of Neoplasia Block 240 of ths section must be completed with the appropriate response. If the veteran has a neoplasm or has a known history of a neoplasm, document the appropriate diagnosis and the specific ICD-9-CM diagnostic code must be listed in blocks 241 to 245. If no neoplasm is recorded, leave blank. Item 30 - No Disease Found If no disease is found, put a 1 in block 246. Otherwise, leave this block blank. Item 31 - Years of Onset For each listed diagnosis in item 28, code the last two digits of the year of onset; leave blank if year of onset is unknown. Item 32 - Disposition Place a code (1 or 2) in each block provided. Do npt leave any of the blocks blank. For section d in item 32, if the veteran was referred for VA outpatient care, indicate the two digit code for the clinic in the designated blocks (257-266). Refer to the Outpatient touting List (VAF 10-2875-1) for the clinic codes to be utilized to code this section. Item 33 - Remarks Utilize this space for additional information. Item 34-36 - Name and Title of Examiner The name and title of the examiner should be printed in the space provided. The examiner should also sign his/tier name. Information to be abstracted for a follow-up examination: Items 1 through 13 - must be completed Items 14 through 20 - no entry Item 21 - must be completed Items 22 through 33 - may be blank unless you have follow-up data to report in in any of these items. Items 34 through 36 - must be completed PLEASE NOTE; The first time a follow-up visit is recorded on the revised code sheet for a veteran who previously received an initial exam recorded on the old code sheet, every attempt should be made to obtain and record the information to complete Items 14-20. C-5 �Attachment D Circular 10-83- 38 March 1, 1983 DEFINITIONS FOR TOE M3NTOLY BEPORT TERMINOLOG? 1. ""initial Examination: First time Agent Orange examination given for the purpose of entering a Vietnam veteran into the Agent Orange Registry, ttie total of initial examinations given during the period of the current report (i.e., 30 initial exams given during January). 2. Cumulative Initial Examination: Includes the total number of "first-time" examinations performed by the medical facility since the beginning of the registry in 1978. Examinations performed by satellite outpatient clinics should be included in the total cumulative figure for the VA medical center of jurisdiction. Independent outpatient clinics should report in a manner similar to the VA medical centers. 3. Follow-up Examination: Any Agent Orange-related examination/visit subsequent to the initial examination. 4. Cumulative Follcy-up Examination: Includes the total number of follow-up Examinations performed by the medical facility since the beginning of the registry in 1 7 . 98 5. Pending Examinations; Initial Agent Orange examinations for which appointments have been scheduled beyond the end of the month. 6. Number of veterans failing to keep an initial examination appointment; number of veterans who tailed to Keep a scheduled appointment during the month. ~2 0 D-l �ATTACHMENT E Circular 10-83-38 March 1, 1983 EXAMPLE (FACILITY LETTERHEAD) —- Agent Orange Projects Office (10A7) ATTN: Nancy L. Howard, HRA VA Central Office, Pm. 848 810 Vermont Avenue, N.W. Washington, D.C. 20420 SUBJECT: Monthly Report en Possible Exposure of Veterans to Herbicides During the Vietnam War, RCS 11-49 1. The following information is submitted for the month ending _...._. t facility number . a. Total number of initial examinations performed b. Cumulative total of initial examinations performed ".. . . c. Total number of follow-up examinations performed d. Cumulative total of follow-up examinations performed e. Number of pending initial examinations at the end of the month f. Number of veterans failing to keep an initial examination appointment 2. Garments/problems regarding pending exams: 3. The name and ETS number of the person preparing the report: (Name) MEDICAL CENTER DIRECTOR •M4>1 E-l �\\ /r March 1, 1983 !! TU'.KNT ORANGE CLAIMS i _ Nuinbe r A. Total Number of Claims Claims with Diagnosis Confirmed Claims with Diagnosis not Confirmed Claims with No- Disability Alleged B. Claims with Diagnosis Confirmed Allowed for Reason Other than Agent Orange Denied a. 16821 100.0* 8341 4456 4024 49.6% 26.5% 23.9% 8341 100.0% 1300* 7041& 15.6% 84.4% These 7041 claims having more than one claimed diagnosis fall into the following categories: Skin condition (acne, alopecia, eczema, keloids and urticaria) Nervousness, headaches and fatigue (claimed) Paralysis or numbness and other symptoms of extremities GI and GU conditions Malignancies (leukemia, lymphoma, melanoma, Hodgkin's, etc.) Impaired sexual activity (alleged) Y ''- EENT' pathology • ' Lung condition Cardiovascular and hypertension Misc. * Percent 4303 2453 SOB 3^0 466 293 252 146 Approximately 94 O rl225 of the total 1300 claims allov-ed are service connected for skin condition. Balance of 6% or 68 claims were allowed for cancer, psychiatric and neurological conditions and various other miscellaneous disabilities. If �84203 r- SENATE "<c> The Secretary, in consultation and < uu veteran ls,,recelvlng a monthly assistance allowance- pursuant to operation with the Aamlntotrator, sb4ll ' rans.. and employers desiring to *1787 of this title; or , , - the employer-Is receiving any .other under this chapter la makihg apassistance (includtog a,tax credit) ^JaMconwW«nec«fs«ry>6rtifica,„__• Federal (Soverament on account of ttohs-In carrying out this rdgpon^bllity, the raining or employment of such veteian. Secretary shall use the services at State and ),lfi the 6886 of an eligible veteran par- Aipsistant State Directors, for Veterans' Em, tldpattng in both a training, program under pTfiymentJK:d|iifiBibj.^<|rv^.^yg-n4yp^^t-y^ftf»vt pro'•this chapter and a vooationarrehabilitatlon grani specialists, and employees of local of'program under chapter 31 of this title, the fices appointed pursuant/to sections 12203, ; provisions of, section. I50a<cXl) of thte.tlUe 2003A, and 2004 of this-fitle. The Secretary shall apply to the'employer to which re- shall also use such resources as are available training assistance is payable, under .this under title Itf-C of J&e Job Training Part, M chapter.''and the wages and benefits paid to nership Act. the employment of the . employer sh&ll be for which the veteran Is to be trained and such veterans by such to the veteran for "81961. CMnUtMtifrit with the Small Business that the employer has no reason tot'expect considered, income paid Administration that that position will hot be available to purposes of such provisions. "<C> Assistance undbr chapter 34 or 36 of • **The Administrator shall requ'est and such veteran at the end of: the, tralnW this title may not be paid to a veteran in obtain from trie Administrator of the Small period;'.' ' "V-7 ' '"V Administration a listing of small "(D) that no currently employed worker connection with such" veteran's participation Business cimeerns, will be displaced Oacluding partially dls- in a training program under this chapter, , business concerns to-particularly new small business sectors of the economy placedt such as through it reduction in non- "B1954. Suspension of payments "If' the Administrator finds that a pro- wlfiich ihave a high potential for sustained overtime work hours, wages. or,benefits), or a regular basis, lald-off workers prevented frooi recall, as a gram of training approved under this chap- , demanjror growth, and, on listings shall be Such result of either the establishment of the ter fails to meet any of the requirements of npdat/ such listings. promote possible train:o Identify and training, ptogram. and the- participation- of this chapter, the Administrator may immeid employment opportunities for eiigisuch veteran to such program or-the subse- diately suspend -the payment of retraining veterans. assistance on behalf of an eligible veteran auent employibent of such veteran; "(E) that the training oaatent of the, pro- participating In such program. The employ- (1962. Coordination with the Department of ee and any educational institution conduct? Education un Is adequate to teg, and each eligible veteran psrtteipatii an partlcipiSUntt in _ . "The Administrator, in consultation and in* such program shall each be notified IE for «Tob to the field cooperatkm with the Secretary of Educamediately of such suspension by a certifU beRcpyldedand«pec or registered letter (return receipt reqytst- tion,' shall take appropriate actions to advise educational institutions of the opportunities made- avatlaWe to veterans under this chapter aod the opportunity for such institu,_. Whenever tfte';.,Arfmlnisi tions to enter into agreements or arrangethat an overpaymefit of retrsL_,_, __„- merits wtth employers porstwnt to section ance under this chapter has yen made to 1861 of tW» title,". > art employer on behalf of on. eEglble, veteran • tb) The t«We of chapter* at the beginning as a result of the willful bnoiegUgeritfalse of sneh title and at the beginning of part HI certification by an emplbyar, the amount of of such title are each amended by mserting such overpayment; shall Constitute a liabili- •fter the item relating to chapter 39 the folof to th/United States. , ty*fl&>the employer the/Administrator ftntfe lowing new Item: Whenever! "(B) that records, needed fe. determine compliance with, the requirements, 01 jbhis that im overpayment of retraining assist- •'40. Emergency Retraining Assist-' fltlOf. , U..U..U. n,...^tiMn....>n. . 1820". chapter vrftt.be igaintalned by the emploser ance under this chifpter has been made to and wfll be available At reason»bJe.Umc» lor tm ettptoyer oh benalf of an eligible veteran SBC. 3. The amendments made by this Act examination by; authorized representatives a»"a result'of the; wfllfnl'or negligent false shall take effect on October 1,1983. Certification by a veteran, the amount o: oj the Jfle^eral Government. ., ,, = . A . aent shall constitute a liablli "(2) Foe the. purposes of thto. siA^ction, 10-83-61, Apr. 5,1983J ty of the veteran to the United States. approval of a program of «wprenti««*l>i*)> or other, on^Job jtralntog for ,tfae purposes of • "<c)(l) Any overpayment referred to in VETERANS ADMINISTRATION, Surgery,, '<a> or'(bX of this section may be Department of Medicine and section 1787 of this title ahall ,Baeet all »equlremaats for approval of aueb. program recovered in the same manner as any other Washington, D.C. debt dyfe the tTnited States. To: Regional Directors: Directors, VA Mediunder this chapter. . . , , .,,;','";.-,.,.;,--•, In this section or any other cal Center Activities, Domiciliary, Outsi6n of this title shall be construed , patient Clinics, and Regional Offices "Anye . . _. _. ding the imposition of any civil or with Outpatient Clinics. ment or agreement with wieittica-MottaT Inal liability under this title or any Information: Directors, Regional Offices; stitution that has been approved for the en- r er law with respect to such an overpayDistrict Counsels. -. .. .rollment of veterans under chapter 34 o: ment. Subject: Guidelines for .Implementation of this MOe in owter thirt snen institution w *SmcmpTKK V—cbojtDHTATroN wrrH OTHER Legislation Related to the .Provision of 1 provide the training program (or a port; •" ' ' i Acunuigs Health Services to Veterans Exposed to thereof) under this chapter. When sueb'an "?1W!0. Coordination with the Department ol Ionizing Radiation As a Result of Detos arrangement or agreement has been entered nation of Nuclear Devices. Labor into, the application of the-employer shall 1. The "Veterans Health Care, Training, "(a) Except so state and set forth a descripthnf of the tion 1932<a) ofas otherwise permitted In sec- and Small Business Loan Act of 1981" waa training to be so provided; ' '"'""' 'Carry, but the this title, the Secretary shall sighed into law on November 3, 1981. The Secretary's responsibilities i? 19S2.1 Nonqualifyingprograms of under this chapter (through the Assistant Act, Public Law 67-73, authorizes the Veterans Administration to provide certain . , ... , "No assistance under this charter may be -Secretary.^ , .,.,. . . . ;,;t(b) The Administrator shall carry out the health e»re services, as described in parapaid on behalf ..of a v«teran provisions of this chapter in consul tatior graph 3, to veterans who, while serving on a pro&pais of traj^itng— and coordination with the Secretary, ant active military doty,, were exposed to ionti"(1) for< employment In ^he. Administrator and the Secretary &hal ing radi&tioa from th« detonation of nuclear mittent, or temporary Job* ,, „ . .„ . , . r Kifekhcoaunis- •-ioJnUy conduct an outreach and public in- device as a result of participation in either tiw testing of »uch a device between 1945 '•forHifttion. program designed to^- , siQnBarftliheprtwurjf .,"Cl);inform eligible .veterans about oppor- and 1W2, or the American occupation of Hitunities, for training under this chapter: ant roshima or Nagasaki,. Japan,, between Sepcal or religions a: or , a -..,-'0 iorm.private Industry and business tember 11. 1945, and July 1, 1946. Verifiea,"(4) It-^h*. _...j {Including1 small business -con- tioaof •ervlceat a atte during the testing of J,;ie4ucatlonal .institutions, trade asaocl- nuclear devices, or to Hlfoahixm/Nagnsaki "9 1959. -» and labor unions, of pppojrtunltle« [ the oocMpation of Japan, during the { „ this chabtet, aM to encourage env ; specified wiU be reouijred. In the tbPloyers and unions to make training pro- S«IK« of affirmaUve evidence to the contncy,» veteraa'» oootenUoa o| exposure at ^— H available for eligible veterans,' L *&* n-i �S4204 CONGRESSIONAL RECORD — SENATE a nuclear device testing site, or In Hiroshima/Nagasaki will be accepted. 2. Health care services may not be provided under this law for the care of condilons which are found to have resulted from ,use other than the specified exposures. . Health care services authorized under is provision are limited to hospital and nursing home care In VA facilities and outpatient care in VA facilities on a pre- or post-hospitalizatlon basis or to obviate a need fo> hospitalization. Such health care services will be provided without regard to the veteran's age, service connected status or the inability of the veteran to defray the expenses of such care. Veterans furnished outpatient care under this authority will be accorded priority ahead of other nonserviceconnected veterans and equal to former Prisoners of War who are receiving care for nonservice-connected conditions. Congress made it clear that this law provides for health care only, and that a determination that the veteran Is eligible for such care does not constitute a basis for service connection or in any way affect determinations regarding service connection. 4. Each veteran who participated in the testing of a nuclear device or who participated in the occupation of Hiroshima or Nagasaki, Japan, between September 41, 1945, and July 1.1046, and who requests VA medical care will be provided a physical examination and appropriate diagnostic studies In accordance with DM&S Circular 1083-12. The examination and studies will be documented in the medical record. If such an examination has been completed within the prior six months, only those procedures which are medically indicated by the current circumstances need be repeated.-Where the findings reveal a condition requiring treatment, the responsible staff physician shall made a determination as to whether A condition resulted from a cause other the veteran's exposure to Ionizing radiVeterans who meet the criteria of this circular may'be treated under this authority. In making this determination, the physician should consider that the following types of conditions are not ordinarily considered to be due to such exposure: (a) Congenital or developmental conditions, e.g., spina bifIda; scoliosis. (b) Conditions which are known to have pre-existed military service.' <c) Conditions resulting from trauma, e.g., deformity or limitation of motion of an 'extremity. . . .• (d) Conditions having a specific and well established etiology, e.g., tuberculosis; gout. (e) Common conditions having a well recognized clinical course, e.g., Inguinal hernia; acute appendicitis. 6. On occasion, the responsible staff physician may find that a veteran requires care for one or more of the conditions listed in paragrah 4, but that the case presents complicating circumstances that make the provision of care under this authority appropriate. In such instances, the physician should seek guidance from the Chief of Staff and the Environmental Physician regarding authorization for treatment. If treatment Is so authorized, the reasons will be clearly documented in the medical record. Veterans who are not provided needed medical care under this circular may be furnished "care U they are eligible under any other statutory authority. • 4. In the event the responsible staff physician finds that a veteran has a condition not linarily considered to-be due to the speclexposure and there are not complicat_ circumstances warranting the provision of care under this authority, the decision and its basis will be clearly documented in the medical record. 7. The provisions of this circular will not exclude any veteran who alleges exposure to ionizing radiation as described in paragraph 1 of this circular from being Included In a VA Radiation Exposure Registry Program, .under development. 8. These guidelines will be effective upon receipt. A copy of the pertinent guidelines should be made available to any veteran seeking care under this authority. 0. This circular rescinds DM&S Circular 10-82-246 dated December 21,1982. ' W. J. JACOBY, Jr., M.D., Deputy Chief Medical Director.• COMMITTEE ON VETERANS'AFFAIRS, Washington, D.C., March 22,1983. Hon. HARRY N. WALTERS, Administrator of Veterans'Affairs, •Washington, D.C. DEAR HARRY: I was very pleased to receive your responsive and forthcoming letter of February 18 regarding new initiatives you plan to take with respect to certain ionizingradlation issues. As you know, I have long been deeply concerned about questions re-' lating to the long-term health effects in veterans of their active-duty exposure to radljition from the detonation of nuclear devices, as well as-the dificulties that some of them have had in obtaining VA health care for disabilities which may be related to their exposure. Likewise, I have been concerned about the difficulties faced by some of these veterans in pursuing claims for compensation and by the survivors of such veterans in pursuing claims for disability and Indemnity compensation. I have several follow-up thoughts to share with you arising out of your letter. 1. As the author of S. 11, which contains a provision to mandate a morbidity study of these veterans, I am particularly encouraged by your plan to explore with the Interagency Radiation Research Committee the feasibility of conducting such a study. I urge that you also consult with National Academy of Sciences staff members, such as Seymour Jablon and Dennis Robinette, on the feasibility of the study. As a result of NAS' long-standing Involvement with various radiation-related efforts—including the U.S. participation in evaluating the experience of the Japanese survivors of Hiroshima and Nagasaki, the work of the Committee on the Biological Effects of Ionizing Radiation, and NAS' ongoing mortality study of some 55,000 veterans who participated in the atmospheric nuclear testing serious—NAS has developed perspectives and expertise that could be of substantial value to you in your consideration of undertaking such a study. In addition, some NAS staff members have' .given thought to possible means of studying birth defects in the offspring of exposed veterans, an issue.that should constitute.a crucial part of any morbidity study. 2. Your proposal to call upon experts in the field of nuclear effects to evaluate the National Library of Medicine's reports on the radiation literature and to consider the epldemiological recommendations of the IRRC is a useful step forward. However, I believe that such a collection of experts could, as an ongoing committee where views could be exchanged directly on a variety of Issues, lend valuable expertise to the VA in more than these two limited areas. Such a committee could, for example, stimulate the development of and help to evaluate proposals for other radiation-related research relevant to veterans' concerns and provide ongoing advice on any'morbidity study that Is developed. I also believe that such a committee could serve as a valuable resource for the Board of Veterans' Appeals, the Chief April 6,1983 Benefits Director, and the Chief Medical Director and would generally be a worthwhile, continuing supplement to the VA's admittedly small Central Office staff in this area. Thus, I urge that you reconsider your present position as stated In your earlier, February 4 letter to me and take steps to establish such an entity on a formal basis. 3. Having previously written the Chief Medical Director and the former Administrator regarding health-care eligibility under section 102 of Public Law 97-72 for veterans exposed to Ionizing radiation om three occasions, I very much support the steps you are taking to ensure that the implementation of this provision does not reflect differing interpretations of the law for veterans'exposed to Agent Orange and for those exposed to ionizing radiation. Under section 102, veterans who experienced certain exposure to Agent Orange or Ionizing radiation are eligible for care for disabilities that cannot be determined to result from causes other than their exposure to Agent Organge or ionizing radiation. As the Senate author of this provision of law, I have been concerned that the implementing guidelines issued by the VA treat the two groups of veterans differently. The Agent Orange guidelines reflect the proper approach of specifying the particular categories of disabilities that the VA has determined are not caused by Agent Orange exposure and which thus do not provide a basis for eligibility. The VA guidelines afford VA health-care eligibility for all other disabilities of Agent Orange-exposed Vietnam veterans. By contrast, the guidelines provide access to care for veterans who have been exposed to radiation only if they have certain specified types of disabilities, apparently those that the VA considers are likely to be caused by radiation. Thus, I am pleased that you -have directed that the circulars pertaining to this authority be revised to "have comparable expression of policy"—apparently to bring the radiation policy into line with the Agent Orange policy—and I look forward to the issuance of the revisions. As I have already indicated, Harry, I believe the initiatives you outlined ui your February 18 letter are very positive, and I congratulate you on them. I look forward to learning your thoughts on the suggestions set forth above and to your carrying out efforts to address the Important concerns of veterans exposed to ionizing radiation as a result of nuclear detonations. With warm regards, Cordially, ALAN CRANSTON, • Ranking Minority Member. -VETERANS ADMINISTRATION,-OFFICE \OF THE ADMINISTRATOR OF VETERANS AFFAIRS, Washington D.C., February 18,1983. Hon. ALAN CRANSTON, Ranking Minority Member, • Committee on Veterans' Affairs, U.S. Senate, Washing• ton, D.C. DEAR SENATOR CRANSTON: [Regarding' our programs concerning veterans exposed to ionizing radiation as a result of detonation of nuclear devices,! am-pleased to advise' •you of several new initiatives. First, the Veterans Administration has requested the Interagency Radiation Research Committee to provide its advice on the feasibility of conducting a morbidity study of veterans exposed to radiation during active military duty. Secondly, we have requested the National Library of Medicine to make available to the Veterans Administration their extensive literature reviews on the health effects of ex-- �April 6,1983 I S4205 CONGRESSIONAL RECORD — SENATE .ppsure to nuclear radiation. The Director of the National Library of Medicine, Dr. Martin M. Cummlngs, has charged his staff epidemiologist. Dr. Clifford Bachrach, and researcher. Miss Charlotte Kenton, with the responsibility of making available to the Veterans Administration their past extensive literature searches on the health effects of nuclear-radiation and, beginning March 1, 1983, of supplying the Veterans Administration with monthly reports of worldwide radiation research. We also will call upon experts in the field of nuclear effects to evaluate the National Library of Medicine's reports, and to consider the epidemiologlcal recommendations of the Interagency Radiation Research Committee. There will also be ft periodically tipdated manual for the use of Veterans Administration physicians In the examining and treating of veterans exposed to ionizing radiation while in military service. finally, we have undertaken to revise the instructions to the various VA medical centers concerning the implementation of Public Law 97-72 relating to the provision of health care services to veterans exposed to ionizing radiation as a result of a detonation of nuclear devices. The revision is being made so as to have comparable expression of policy regarding radiation as now exists .with respect to veterans exposed to dioxin. Regarding the issue of the relationship between exposure to dioxin and the subse' quent development of soft tissue sarcomas, the Veterans Administration is unable at present to find scientific proof that Agent Orange or Its ingredients are causes of one or more of the group of diseases called softtissue sarcomas. We are continuing the undertaking of a detailed literature search, and data review on illnesses and death among Vietnam veterans, Including the files of the Armed Forces Institute of Pathology. I will, of course, keep you advised of further developments in this matter. . Sincerely, ,' HARRY N. WALTERS, Administrator. VETERANS' ADMINISTRATION, ' Washington, D.C., February 3,1983. Hon. ALAN CRANSTON, Ranking Minority Member, Committee on Veterans' Affairs, V.S. Senate, Washington, D.C. DEAR SENATOR CRANSTON: A letter regarding ionizing radiation was forwarded to your office on January 12,1983. The prudence of establishing a VA Committee on Ionizing Radiation was discussed in that letter. It 'has come to my attention that the reference to -that committee was misleading. Permit me to rectify the situation. In 1978 the agency developed an informal task group which functioned as a quasi commlt' tee. Consideration was given to establishing a formal advisory committee; however, it was decided not to do so at that time. It was the judgment of the agency that a less formal approach would be both responsive and cost-effective in meeting agency needs in the area of ionizing radiation. It is acknowledged that this approach, albeit satisfactory In meeting the Veterans Administration's needs, does not address the broader concern about the need for a statutory committee raised in your October 15. 1982 letter. However, Dr. Curtis and I believe that the practice of using eminently qualified scientists and professionals as a consultant group does meet our program needs. A list of those individuals Is Included in Attachment A for your information. Certainly we agree with the notion that ionizing radiation is a subject which holds a broad national concern. The broader national concern seems to cut across a* more uni- versal societal Interest than the mission and constituency of the Veterans Administration. Therefore, we do not believe that a statutory or otherwise formally chartered committee on ionizing radiation for the Veterans Administration Is indicated. Rather, the universality of the Issue suggests that the establishment of a statutory committee within an agency having a more universal and primary mission associated with national health issues and problems would be more appropriate. We have highly skilled professionals who could contribute to such a committee.should one be established; and, we would be pleased to participate together with other .federal agencies, as a member of such a committee: Again, I assure you of our concern with the adverse effects—real and perceived—of both agent orange and ionizing radiation. We remain fully committed to torthrightly addressing these issues as they relate to veteran .health care concerns and serving America's veterans openly, honestly, and compassionately consistent with the intent of the Congress. Sincerely, HARRY N. WALTERS, Administrator. CONSULTANT GROUP ON NUCLEAR DEVICE TESTING AND RADIATION EFFECTS , Dr. John A. Auxier, Division Director, Industrial Safety and Applied Health Physics, Oak Ridge National Laboratories. Dr. Gilbert W. Beebe, Clinical Epidemiology Branch, National Cancer Institute, NIH. Dr. Eugene P. Cronkite, Chairman, Medical Department, Brookhaven National Laboratory. Dr. Karl P. Hubner, Medical and Health Sciences Division, Oak Ridge Associated Universities, Oak Ridge, Tennessee. Dr. John S. Laughlin, Chairman, Department of Medical Physics, Memorial Sloan Ketterfng Cancer Institute. Dr. Takashi Makinodan, Director, GRECC, West Los Angeles, VAMC. Dr. Klaus Mayer, Chief, Hematology, Memorial Sloan Ketterlng Cancer Institute. Dr. Thomas O. Mitchell, Associate Professor of Radiology (Nuclear Medicine), Associate Professor of Environmental Health Sciences (Radiation Health Sciences), Johns Hopkins Medical Institutions. Dr. William C. Moloney, Professor, Emeritus of Medicine, Harvard Medical School; Chief, Emeritus, Hematology Service, Peter Bent Brigham Hospital. Dr. Robert C. Ricks, Medical and Health Sciences Division, Oak Ridge Associated Universities, Oak Ridge, Tennessee. Dr. Henry N. Wagner, Jr., Professor of Medicine, Radiology, and Environmental Health Sciences; Director of Divisions of Nuclear Medicine and Radiation Health, Johns Hopkins Medical Institutions. Dr. Rosalyn 8. Yalow, Senior Medical Investigator, Bronx VAMC, N.Y., N.Y.; Chairman, Department of Clinical Sciences, Montefiore Hospital, Bronx, N.7.; Distinguished Professor at Large, Albert Einstein College Of Medicine, N.Y., N.Y. with the adverse effects—real and perceived—of both Agent Orange and ionizing radiation on America's veterans. In that regard, I have directed my people to ensure that unexplainable inconsistencies in our handling of Agent Orange and iodizing radiation are removed so as to conform to the needs of our veterans and the intent of Congress. The issue of ionizing radiation is a continuing one which has been discussed and researched for years. Agent Orange, on the other hand, is a more contemporary issue. Because less is known about its effects, the vast number of personnel exposed to the substance are fearful, and rightfully so. The VA.has a long established Committee on Nuclear Device Testing and Radiation Effects, and participates in numerous meetings of other committees in the field of ionizing radiation. I cannot see, at this point, where the 'establishment of another VA Committee would be particularly beneficial. However, if you believe that a governmentsponsored committee to examine the effects of radiation on humans—probably under the auspices of the Department of Health and Human Services—would be of value, the VA would be pleased to serve. Discussions regarding a literature search and epidemiologlcal studies are enclosed. I hope you find these helpful. Additionally, with regard to your question about DM&S Circular 10-81-250, it will be published in the near future. Sincerely, HARRY N. WALTERS, Administrator. LITERATURE SEARCH The vast literature on the biological effects of ionizing radiation has been meticulously searched, evaluated, and summarized by qualified professionals In the earlier publications, Biological Effects of Ionizing Radiation (BEIR) United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR), as well as in such others as the 1981 report. Federal Research on the Biological and Health Effects of Ionizing Radiation (FREIR), which is the work of a 29-member committee aided by 123 outstanding consultants in the field of the biological effects of ionizing radiation. . The 1977 UNSCEAR report is about to be superseded by a new UNSCEAR report. In addition, the reports of the Intergency,Radiation Research Committee (IRRC), together with those of the National Council on Radiation Protection (NCRF), and the International Commission on Radiological Protection (ICRF), are continually published and read by experts, including our VA scientists. Beyond this, the VA maintains a current search of the literature on the biological effects of ionizing radiation through computer utilization of the National Library of Medicine and the monthly Cumulative Index of Medicine. The literature on ionizing radiation has been, and continues to be, as thoroughly explored as any literature on any scientific topic in the world. It is the consensus of experts in the matter of ionizing radiation that the literature on this subject has been so thoroughly searched and researched that. still another review would not only be redundant, but also would divert scientific effort and money from more profitable new directions such as Investigations of the effect of low-level ionizing radiation at cellular and molecular levels. VETERANS ADMINISTRATION, Washington, D.C, Jan. -12,1983. Hon. ALAN CRANSTON, Ranking Minority Member, Committee on Veterans' Affairs, V.S. Senate, Washington, D.C. DEAR SENATOR,CRANSTON: I am pleased to respond to your October 15, 1982, letter to then Administrator Robert P. Nlmmo on EPIDEMIOLOOY the subject of ionizing radiation. Let me first state that as Administrator of Because there may not be general awareVeterans Affairs I will be equally concerned ness of the extensive epidemiological and 77-3 �S4206 • CONGRESSIONAL RECORD — SENATE human effects of ionizing radiation, the most comprehensive total figures currently available, those In the 1981 rlusut report follow. In Fiscal Year 1979, 17 Federal agencies, employing 601 investigators, spent mi * 11,045,595 on studies of the bloeffects of izing radiation. 'Of that total, $79,667,997 (72%) was devot__ 'ed ito epidemiological studies by 413 investigators. •"• The Veterans Administration, in matters of veteran health and radiation effects, correlates information obtained from pertinent literature, the opinions of its consultant group on radiation effects, the attendance of its experts at germane scientific and interagency meetings, data from the Defense Nuclear Agency and the Nuclear Test Personnel Review, and from opinions 'expressed at meetings with various veterans' groups and representatives of service organisations. COMMITTEE ON VETEBANS' AFFAIRS, Washington, AC, October IS, 1982. Hon. ROBERT P. Nnmo, Administrator of Veterans'Affairs, Washington, D.C. DEAR BOB: Last February I wrote Don Custis with specific comments oil the Veterans' Administration's published guidelines— DM&S Circular 10-41-250, Interim Guidelines tor Implementation of Legislation Related to the Provision of Health Care Services to Veterans Exposed to Ionizing Radiation as a Result of Detonation of Nuclear Devices"—issued on November 18, 1981, in implementation of section 102 of Public Law 97-72. In that letter, I stressed that the Guidelines as they pertained to radiation-related conditions were overly restrictive In two respects: First, they would exclude conditions which could not be shown to have resulted from & "cause other than exposure to radiation", the criterion in section .O(a)UXB) as added by section 102 of tblic Law 97-72; and, second, they also ight conditions, 1 exclude which theresuch as thyroid ....j 'disorders, as to is scientific evidence linking them to exposure to radiation. In Dr. Custis' response of April 6,1962, he indicated that the final Guidelines would Include thyroid nodules as an addition to the class of disorders—otherwise limited to cancers—that would be considered as not having resulted from a cause other than exposure,to radiation for purposes of establishing health-care eligibility under the new law. Although I welcome this addition, I remain troubled by the agency's interpretation of Public Law 97-72 as it relates to veterans exposed to radiation. The approach adopted thus far suggests a fundamental inconsistency between the Guidelines applicable to those veterans exposed to Agent Orange and those exposed to radiation. In light of the paucity of knowledge on the health of each of these two populations and considering the ongoing controversy in the literature on the effects of radiation and of Agent Orange exposure on humans, I believe that, as a minimum, equal latitude for access to VA health care should be provided in the Guidelines for those exposed to radiation and those exposed to Agent Orange. To do otherwise on the basis of the current state of knowledge would be, to my view, unjust and not in conformity with the underlying intent of Congress. On this point, a story (copy enclosed) carried on September 20,1982, by United Press International relating to a press conference ild that day by members of the national ;ociation of Atomic Veterans, noted that Hickman, speaking for the agency, said that "anyone who believes he was « exposed to radiation is getting free treatment at agency hospitals". Such a result, which comes much closer to the Implementation of section 102 of Public Law 97-72 with respect to Agent Orange exposure, is not consistent with the approach in the Interim Guidelines. I urge that this matter be clarified in the Guidelines; alternatively, but far less satisfactorily, the information provided by those representing the agency in public statements should be conformed to the Guidelines. The differences in the Guidelines for implementing Public Law 97-72 are only one example of the differences in the way the VA responds to issues associated with veterans potentially exposed to herbicides in Vietnam and those exposed to low-level Ionizing radiation. In general, the agency is devoting significant resources and attention to Agent Orange-related issues; a comparable level of activity Is not present regarding radiation-related issues. I believe that this lack of attention to the radiation issue is not justified. • I have in the past urged greater attention to this issue and am writing to you today to recommend that, in order to help remedy this deficiency, the VA take the following concrete steps: (1) Establish entities relating to radiation exposure analagous to the Agent Orange Policy Coordinating Committee—so that internal agency efforts to address these matters may be examined, compared, and coordinated, which should promote greater awareness within the VA—and the VA Advisory Committee on Health Related Effects of Herbicides—so that outside expertise, veterans organizations, and public interest groups can be brought together in a public forum. (2) Conduct, directly or by contract, a comprehensive review of the scientific literature on the health effects of exposure to ionizing radiation. <3> Give 'serious consideration to conducting or providing for the conduct of an epidemiological study, relating to morbidity and genetic damage, of veterans exposed to radiation resulting from nuclear detonations. I have long believed that a literature review would be a worthwhile undertaking. The version of S. 971 passed by the Senate on July 24, 1981—a measure ultimately enacted as Public Law 97-66—contained a provision I authored that would have required the VA to conduct a review and analysis of literature relating to the long-term adverse health effects of human exposure to radiation and to consult with and actively coordinate with other Federal Government entities involved in radiation exposure-related activities. Although this provision was not accepted by the House. I have continued to urge that such a review be carried out, with or without a legislative mandate. Such a review would serve to ensure that the VA is more fully informed regarding radiation exposure and would pull together available relevant scientific information on this issue. I believe that it would, enhance the VA's ability to resolve fairly and consistently the very complex issues involved in radiation-related VA compensation and DIC claims. The VA, in dealing with radiation-related claims, has relied heavily on comprehensive reviews, such as the 1972 and the 1980 reports of the Committee on Biological Effects of Ionizing Radiation (BEIR) of the National Academy of Sciences and the 1977 report of the United Nations Scientific Committee on the Effects of Atomic Radiation. Because these reviews were concerned primarily with determining minimum exposure levels that might be considered safe, because of the time, that has elapsed and April 6,1983 the studies that have been completed since these reviews were published, and bScaflse many individuals, including researchers and veterans' representatives, have advised me that the anal ago us Agent Orange literature review has been very useful, I believe that a literature review is warranted to update' and consolidate information from the BEIR, UN, and other reports. Hence, I urge that you reconsider your decision not to conduct a literature review, as outlined in your August 13,1981, letter to me. Regarding an epidemiological study, I am aware that limited consideration of such a study has already been given by various governmental and non-governmental entities, including the National Academy of Sciences. The Academy is currently engaged in conducting a mortality study but not a morbidity study of veterans exposed at test sites. Its August 1981 report on the feasibility of an epidemiological study of those veterans who were present at Hiroshima and Nagasaki concluded that a morbidity study was not feasible and that a mortality study would not be cost effective. Because our troops' exposure levels in Hiroshima and Nagasaki are considered generally to have been lower than those received at the Pacific or U-S. test sites, the NAS' 1981 analysis and conclusion (which is not free from controversy) relating to a study of veterans exposed at Hiroshima or Nagasaki does not suggest that the same conclusions should be reached with respect to an epidemiological study of the morbidity of veterans exposed to radiation at the test sites. Thus, I believe that the subject of conducting a morbidity and a birth defects study to complement the NAS mortality study in progress merits further consideration by the VA, I would appreciate your views on these most important matters as well as information on the current timetable for the issuance of the final Guidelines. I know that you share my concern that our -Nation's veterans be treated fairly. With warm regards, Cordially, ALAN CRARSTOW, Ranking Minority Member. WASHINGTON.—Angry and scarred veterans who claim their problems are due to exposure to atomic test blasts in the 1950's won a pledge from Congress to hold hearings on the subject next year. The National Association of Atomic Veterans; representing 260,000 men who were exposed to 235 above-ground atomic tests from 1945 to 1963 or who .served in Hiroshima and Nagasaki after the Japanese cities were destroyed by atomic bombs, successfully lobbied Monday with chairmen of the House and Senate Veterans Committees. At an earlier news conference, they expressed anger—in some cases they were near tears—at the Defense Department's and Veterans' Administration's refusal to certify the men as having service-connected disabilities. "Our people are dying at an alarming rate from cancer and other diseases and Government agencies refuse to help," said John Smitherman of Fayettevflle, Term., a legless veteran whose left hand is deformed by deterioration of his lymphatic system. But VA spokesman John Hickman called the veterans' charges of a coverup "utter nonsense" and said anyone who believes be was exposed to radiation is getting free �April 6,1983 CONGRESSIONAL RECORD — SENATE treatment at agency hospitals. He said 2,882 veterans have asked for treatment. VETERANS ADMINISTRATION, Washington, D.C., April 6,1982. Hon. ALAN CRANSTON, -Committee on Veterans'Affairs, V.S. Senate, Washington, D.Or DEAR SENATOR CRANSTON: Thank you for your letter of February 23, 1982, commenting on DM&S Circular 10-81-250 "Interim Guidelines for Implementation of Legislation Related to the Provision of Health Care Services to Veterans Exposed to Ionizing Radiation as a Result of Detonation of Nuclear Devices." As you know, the "Guidelines" were published in the Federal Register of December 2, 1981 (Vol. 46, No. 231, page 68637) for the purpose of soliciting comments on the proposal. Among the comments received was the suggestion that thyroid dysfunction be included with cancer in paragraph 4 as a consequence of exposure to ionizing radiation. My staff gave careful consideration to the matter and we are in the process of adding thyroid nodules as a consequence of exposure. Hypothyroidlsm was considered with other dysfunctions and was not Included because it seems extremely unlikely to result from the type of exposure sustained by military personnel at atmospheric or submarine' nuclear tests. Hypothyroidlsm results from intense ionizing radiation to the neck or, as ' in the Marshallese, from Ingestion of considerable amounts of iodine made radioactive by ionizing radiation. Veterans were not exposed to either hazard. Much consideration has been given to disorders that might be considered late effects of low-level radiation. The "Report of the Interagency Task Force on the Health Effects of Ionizing Radiation" discussed the issue in the summary volume (pages 31 to 38) and in the "Report of the Work Group on Science" (pages 7 to 20). The "Federal Research on the Biological and Health Effects of Ionizing Radiation" (BEIR) report of 1981 (Chapter 4) discusses the entire question. Further consideration is contained in the 1977 report of the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR), "Sources and Effects of Ionizing Radiation" (pages 4 to 9). The National Research Council convened a panel of experts which met In May 1981, with participants from various veterans organizations including the National Association of Atomic Veterans. Its report on "Feasibility and Desirability of Performing Epidemiological Studies on U.S. Veterans of Hiroshima and Nagasaki" deals less directly with the question of possible disorders. The report does conclude that it would be impossible to detect any disorders attributable to the radiation exposure. The reported results indicate that some forms of cancer are the only treatable conditions likely to appear years after .exposure to radiation and then usually after much larger doses. Inclusion of all cancers as possible treatable consequences of the veterans' experience reflects a liberal interpretation of the law, as you have urged. The publications,'excerpts from which are enclosed, confirm the conclusions arrived at during less formal contacts with experts from the National Academy of Sciences, the Centers for Disease Control and the National Cancer Institute. There is general agreement that the treatable late effects of lowlevel ionizing radiation are limited to carcinogenesls which Includes the production of "blood cancers", chiefly leukemiaa. Thyroid nodules are included because they must ft V V be diagnosed further as to their possible malignancy. As always, I appreciate your interest. Sincerely, DONALD L. CUSTIS, M.D., Chief Medical Director. .COMMITTEE ON VETERANS' AFFAIRS, Washington, D.C., February 23,1982. Dr. DONALD L. CUSTIS, Veterans'Administration, Washington, D.C. DEAR DON: I am writing to express certain concerns that I have about the radiation exposure part of the guidelines—DM&S Circular 10-81-250, "Interim Guidelines for Implementation of Legislation Related*to the Provision of Health Care Services to Veterans Exposed to Ionizing Radiation as a Result of Detonation of Nuclear Devices"— issued on November 18, 1981, in Implementation of section 102 of Public Law 97-72. Section 102 provides certain VA healthcare eligibility to veterans who were exposed to ionizing radiation from nuclear detonations during their active-duty service. With the exception of a disability found, in accordance with guidelines issued by you, "to have resulted from a cause other than such exposure", Congress expressly provided that this new eligibility is for health care for any disability from which the veteran is suffering even though "there is insufficient medical evidence to conclude that such disability may be associated with . . . exposure [to such radiation}". Specifically, my concern is that the statement in paragraph four of the guidelines that "conditions other than cancer are usually considered to be due to causes other than exposure to radiation" may be overly restrictive in seeming to exclude treatment, pursuant to the new eligibility, for disabilities that may be, and in some cases disabilities that have been determined by apparently credible professionals to have been scientifically shown to be, related to exposure to ionizing radiation. As discussed in the explanatory statement that was inserted in the record of the debates on final passage of this measure in both Houses (Congressional Record H6813, October 2, 1981. and S11573, October 16, 1981. (daily ed.)), the Veterans' Affairs Committees intended that the authority* to issue guidelines providing for the • exclusion of certain disabilities be used "so as to provide a basis for examining physicians to reach a medical Judgment that the cause of the claimed disability is clearly something other than the exposure in question" (emphasis added). Thus, I believe that when there is conflicting evidence, or even merely suggestive evidence, of a relationship between a health disorder and exposure to ionizing radiation, you should exercise great caution in excluding that disorder from the category of disabilities for which treatment would consistently be made available under the new eligibility. I recognize that paragraph five of the guidelines provides for individual case determinations, in situations of doubt, by the attending physician and the Chief of Staff of the facility concerned, and thereby allows for some degree of flexibility. However, I believe that too many disorders may have been relegated to this category, for which uniform guidance is not provided. Certain thyroid disorders other than cancer are a good example of such. The Review of Medical Findings in a Marshallese Population Twenty-Six Yearq After Accidental Exposure to Radioactive Fallout by Robert A.'Conrad, M.D., et at, of Brookhaven National Laboratory, states on page S3: "It has been clearly demonstrated that the most serious effects of accidental exposure to fallout in the Marshallese residing S4207 on Rongelap and Utirik Atolls on March 1, 1954, has been related to radiation injury to the thyroid, as evidenced by development of nodularlties and hypofunction of the gland." That report further states that the principal effects of thyroid exposure in the Marshallese were development of nodujes(benign and malignant) and hypofunction. Although malignant nodules in veterans exposed to radiation would be covered by paragraph four of the current guidelines, treatment of thyroid hypofunction and benign nodules would not. In a similar vein, I note that Public Law 05-134, which authorized appropriations for compensation of Marshallese exposed to radiation as a result of the nuclear test program, clearly recognized the association between such exposure and thyroid disorders. That-law required the Secretary of the Interior to "pay $25,000 to each such individual from whom the thyroid gland or a neurofibroma in the neck was surgically removed, or who has developed hypothyroidism. or who develops a radiation related malignancy, such as leukemia." Although the basic purposes of Public Law 95-134 and Public Law 97-72 differ, each recognizes the possibility of health effects in humans of exposure to ionizing radiation, and it seems inappropriate to me that VA health care would not be authorized under Public Law 97-72 for the same conditions for which exposed Marshallese are being compensated under Public Law 95-134. On this point, I realize that there is some controversy in the literature on radiation-related thyroid disorders regarding the relationship of both sex and age to increased risk of .radiation-related thyroid disorders; however, Public Law 95134 makes no distinction for the purposes of compensation between male and female or between persons exposed as adults and those exposed as children. I am also concerned that paragraph four of the guidelines may exclude, or may impede appropriate recognition of, other possible health effects of ionizing radiation in veterans requesting health care under the new eligibility. Thus, I urge that in addition to the publication of guidelines in the Federal Register you specifically consult with a wide range of specialists and other interested and knowledgeable parties, such as the Centers for Disease Control, the National Academy of Sciences, Brookhaven National Laboratory, and the National Association of Atomic Veterans, on the possible adverse health effects of exposure to ionizing radiation. I would appreciate receiving a report on any such consultations that you have and any previous consultations that were had in formulating the interim guidelines, including the recommendations offered by each party consulted. Don, I appreciate your continuing cooperation. .With warm regards, Cordially, ALAN CRANSTON, Ranking Minority Member. By Mr. DURENBEROER: 8. 993. A bill to provide a program of emergency unemployment compensation for areas experiencing high rates of unemployment; to the Committee on Finance., • . EMERGENCY UNEMPLOYMENT COMPENSATION ACT OF 1983 • Mr. DURENBERGER. Mr. 'President, Congress has an obligation to do everything it can to produce a rapid and sustained economic recovery. But �CONGRESSIONAL RECORD — SENATE \ while we work for that recovery, we reached the 4-percent IUR rate for days' written notice *o the Secretary, *ermi. agreement. have *n egaally important obligation statewide extended benefits. .Bot the nate such such agreement shall provide that <b) Any to protect the millions of Americans simple fact that MinneBOtans are now the State agency of tbe State will make pay.o are out of work through no fault eligible for extended benefits does not meats of tauKcgeacf oooapensslion— itheir own. Last month in the jobs obviate the need far this legislation. U) to individuals who— and the social security trill Con- Areas of the country such as the-Iron (A) have exhausted all tights to regular" took important steps toward put- Range that are undergoing fundamen- compensation under the State Jaw and to ting people back to workv&nd providing tal economic changes will still need Federal supplemental compensation voder additional relief through the supple- protection when other areas are par- the Federal Supplemental Compensation mental compensation program to ticipating more fully to the burgeon- Act of 1962; • CB) have no rights to compensation (inthose onable to find jobs. ing economic revival. compensation, extending Those actions, however, fail to ad- Mr. President, I am not asking the ctnding regularand Federal supplemental compensation, dress a major problem in the extended Federal Government to be the sole compensation) with respect to a week under benefit part «f our current nnemploy- savior of the unemployed hi Minneso- such laws or any other State unemployment ment compensation law. Current law ta. This must be a concerted effort by compensation taw or tinder any other Federtreats a State as a single entity when all levels of government and the pri- al tew; and determining eligibility for extended vate sector «s well. In fact, the State (C) we not receiving compensation with benefits. This ignores the fact that of Minnesota and the private sector respect to wich week onder the -anemptoyareas within a Stai*—such as Minneso- have taken steps and are developing ment compensation law of Canada, ta's Iron Range—may suffer extremely more programs to help deal with the <J) tor any week of Tjnemployment -which in— • high and prolonged unemployment, Iron Range's crushing unemployment. beginsan emergency benefit period (as de<A) despite the fact that the State's over- a number of these programs are iong fined in subsection (c)(2)). and all unemployment rate may be below term, designed to solve the problem of <B) the tadtvldnaVs period of eligibility (as the "trigger rate" for extended bene- the displaced worker. But relocation, defined in section 5<a>( 2)); fits. I am introducing legislation today retraining, and economic recovery take except that no payment of emergency comto correct this problem by permitting time. Unless we help—these people pe&sation Jihall he made to any Individual States to designate areas' within a will not have the time, for say week of. unemployment which State as eligible for extended benefits Chronic lone-term unemployment is begins more than two years after the end of if they meet certain criteria. like the stone dropped into a calm the benefit .year lor which he exhausted Ms My hill would modify the require- pond. The ramifications of lone-term rights to regular compensation. teXl) purposes . of subsection ments that trigger eligibility for ex- unemployment expand like the ripples (bXIXAX POTindividual shall be deemed to an tended unemployment compensation on the pond, and the cumulative ef- have exhausted his rights to regular combenefits. It would permit States to fects are devastating—increased Infant pensation loader a State law when— make high unemployment areas eligi- mortality, families going hungry, vital <A) no payments of regular compensation ble for extended benefits even though medical care foregone, increased child can be made under such law because such the State as a whole does not qualify. abuse, and battered spouses. These are individual has received all regular compenTo be eligible, an area would have to only some of the ramifications of long- sation available to him based on employment or wage* during hie base period; or have *n insured unemployment rate term unemployment. <B) hi* rights ) of 6 percent or higher. Mr. President, the supplemental beet terminated to such compensation bave by reason of the «Kpirattan kThe Secretary of Labor would desig- compensation program is providing es- of the benefit year with respect to which the areas, which generally would sential temporary .relief, tot our such rights existed. a mfiUnrum population of 50,000, system of unempJoyDoent compensa- <2> For (Mtrposes of sutaectkm 4bXlKA>. person living or previously working tion will never address the problem of an Individual shall be deemed to have exin an area with a 6-peroent IUR would high unemployment pockets without hausted bis rights to Federal sngpietaeotal be eligible to receive these extended fundamental reform. The people of compensation under the Federal Supplebenefits after his or her regular and the Iron Range need It. The people in mental Compensation Act of 1982 when(A) 00 paynwnts cao fee made supplemental benefits are exhausted. other high unemployment areas need Act because such Individual bas under such received all As with the present extended benefit it. This hill is a first step In the proc- the coittpensatkzm available In his *eeotmt program, the cost would be shared ess, and I urge Its consideration in the established under section BStte) of such Act; equally by the federal Government near future, . (B) such tauiivfciual's period of eligibility and the State. I ask unanimous consent that the under such Act has eacptoed: or Minnesota's unemployment situa- bill be printed in the RECORD. 1C) compensation may n»t be paid under tion in the past 0 months dramatically There toeing no objection, the bill such Act because of the termination date illustrates the need for an area trigger. was ordered to be printed in the set forth ta section *02tfX2> «f such Act. <8)CAXi> POT purposes of subsection The State's February total unemploy- RECORD, «s follows: . <bX2XA), in ttoe case of any area of a State, ment level, the roost recent data avaQ, an emergency benefit period— aWe, was 10.4 percent. The IUR was Be it enacted, by S.BB3 <I> with Homse under 5 percent—below the trigger' RepreseMlaixees of the Senate vnd State* of weekshall beginthere the third week after a Ote United of for which to an area "emergency level for extended benefits. America in Congrest ustemtted, on" indicator; and Yet, the unemployment levels in a ill) shall end with the third week after • SHORT number of Minnesota counties are SECTION 1. This Act TITLE be' cited as the the first week for which there Is an area may staggering. In Lake County the unem- "Emergency Unemployment Compensation "emergency off" indicator. <ttj In ttie •ease of any area »f * State, no ployment rate is 25.9 percent—2% Act ol 1988".. . ' emergency benefit period shall last for a times the national average. In St. "~ TEMaUJ^SIATE AC.BKEMRMT8 period of teas than 18 consecutive-weeks. Louis County it is 23 percent, and in SEC. 2. <a) Any State, the State unemploy- <iit) When a determination has been made Itasca County 22.5 percent. Nor is the ment compensation law of which is ap- that an emergency benefit period is beginIron Range the only part of the State proved by the Secretary of I*bor Herein- ning or -ending with respect to any area of a with high unemployment. Elsewhere, after in this Act referred to as the "Secre- State, the Secretary snail cause notice of the counties of Clearwater, Morrision, tary") -under section 8324 of the Internal such determination to be published in the Bed Lake, Marshall, Roseau, and Koo- Revenue Code of 1954, nay enter into and Federal Register. chiching also have high jobless levels. participate In an agreement with the Secre- (BXi) For purposes of wibparagrapb. (A), Act, When I introduced this same bill last tary under this date If such State law con- there 1s an area "emergency on" indicator tains such year the unemployment rates in these tered (as of therequirementagreement is en- for A week If the rate «f insured tmemployinto) a that extended such area tor the period unties were nearly as high but the compensation be payable thereunder «s pro- uent toweek and the Immediately ccrastettag preceding was only .3.77 percent. Tragically, vided by the Federal-State Extended Unem- of such equaled or exceeded 6 percent. 13 weeks that time the unemployment ployment Compensation Act of 1978. Any (11) For purposes of subparagtaph (A), to the rest of the State has risen State which is a party to an agreement there is an area "emergency off indicator the point where Minnesota has under this Act may, upon providing thirty for a week if the rate of insured unemploy- 84208 �Veterans Administration CIRCULAR 10-82-185 Department of Medicine and Surgery c Washington, DC 20420 September 16, 1982 TO: Directors, Medical Centers, Medical and Regional Office Centers, Regional Offices, Regional Offices with JDutpatient Clinics, Domiciliary, and Outpatient Clinics SUBJ: Guidelines for Implementation of Legislation Related to the Provision of Health Care Services to Veterans Exposed to Dioxins i 1. The "Veterans' Health Care, Training, and Small Business Loan Act of 1981" was signed into law on November 3, 1981. The Act, Public Law 97-72, authorizes the Veterans Administration to provide certain health care services, as described in paragraph 3, to any veteran of the Vietnam era (August 5, 1964 - May 7, 1975) who while serving in Vietnam may have been exposed to dioxin or was exposed to a toxic substance in a herbicide or defoliant used for military purposes. Verification of service in Vietnam during the Vietnam era (August 5, 1964 - May 7, 1975) will be required. In the absence of affirmative evidence to the contrary, a Vietnam veteran's contention of exposure will be accepted. 2. Health care services may not be provided under this law, for the care of conditions which are found to have resulted from a cause other than the specified exposures. 3. Health care services authorized under this provision are limited to hospital and nursing home care in VA facilities and outpatient care in VA facilities on a preor post-hospitalization basis or to obviate a need for hospitalization. Such health care services will be provided without regard to the veteran's age, serviceconnected status or the inability of the veteran to defray the expenses of such care. Veterans furnished outpatient care under this authority will be accorded priority ahead of other nonservice-connected veterans and equal to former Prisoners of War who are receiving care for nonserviceconnected conditions. Congress made it clear that this law provides for health care only, and that a determination that the veteran is eligible for such care does not constitute a basis for service-connection or in any way affect determinations regarding service-connection. THIS CIRCULAR EXPIRES ON SETPEMBER 15, 1983 17-7 �CIRCULAR 10-82-185 September 16, 1982 6. In the event the responsible staff physician finds that a veteran has a condition not ordinarily considered to be due to £he specified exposure and there are no complicating circumstances warranting the provision of care under this authority, the decision and its basis will be clearly documented in the medical record. 7. The provisions of this circular will not exclude any veteran who served in the Republic of Vietnam from being included in the VA's Agent Orange Registry Program as outlined in DM&S Circular 10-81-54, dated March 19, 1981. 8. These guidelines will be effective upon receipt. A copy of the pertinent guidelines should be made available to any veteran seeking care under this authority. 9. This circular rescinds DM&S Circular 10-81-249 dated November 18, 1981. W. J. &00BY, JR., M.DT Deputy Chief Medical Director DISTRIBUTION: COB: ( 0 only plus (101B1) 30 and (102) 300 1) SS (102) FLD: MA-300 each and DO, OC & OCRO-JjOJl each and RO-200 each plus 200-8 EX: Box 44-6, Boxes 60, 54, 52-1 each & 63-5 77-9 �'t. REVIEW OF CHLORACNE CLAIMS The. Department of Medicine and Surgery reviewed the Rating Decision Sheets of more than 3000 veterans who had filed claims for compensation with the Department of Veterans Benefits. From them, some 300 cases were selected as having descriptions of conditions that might suggest chloracne. A VA dermatologist then reviewed the medical records of the 300 claimants and identified 14 veterans who could have chloracne. Thus far, 13 of these 14 men have received a medical examination with emphasis on the skin problems; the remaining man has been unavailable. Each of the 13 examinations has been performed by a prestigious private clinic. No case could be diagnosed as chloracne although one man gave a history of exposure that suggests that he has or has had chloracne. His condition is being investigated further. Eleven of the 13 veterans, including the one still being investigated, were diagnosed as having common acne. Although 10 of the 14 veterans have one or more service-connected disabilities, none has been service-connected for chloracne. L. B. Hobson 4/19/83 �Chloracne and the Agent Orange Examination Veterans who served in Vietnam from 1962 through 1971 may have been exposed to Agent Orange, an herbicide widely used to destroy crops or protective cover. Other herbicides and several insecticides were extensively sprayed but Agent Orange contained, as a contaminant, TCDD or dioxin. This substance is highly toxic to some animal species, much less so to others, and toxic doses of it cause birth defects if given to pregnant rodents. It may be a carcinogen or may potentiate carcinogens in experimental animals. The immediate effects of TCDD on men have not been so severe as on animals and only chloracne is well established as a prolonged consequence. Chloracne characteristically appears within a few weeks of exposure to a chlorinated hydrocarbon such as TCDD. It closely resembles acne vulgaris and is associated with numerous large comedones and straw-colpred cysts a millimeter to a centimeter in diameter. The acneiform lesions are most common over the malar area, other facial areas, behind the ears, and along the arms, although they may occur on other skin surfaces as well. In most cases, chloracne disappears within a few months or years; cases have persisted for a decade or more without known continued contact with the causative agent. �Veterans have claimed that Agent Orange causes a variety of ill effects that appear or persist over years after exposure. These include many skin conditions, infertility and birth defects, cancer, liver disease, gastrointestinal complaints, neuropathy, fatigability, nervousness, and general debility. None of the varied complaints, except chloracne, has been linked to Agent Orange by conclusive medical or scientific studies. Veterans who served in Vietnam and who express concern about possible exposure to Agent Orange should receive the Agent Orange Registry examination. They should be referred to the Environmental Physician at the appropriate VAMC or clinic if they have not had this examination. If this is not practical, for example, in the case of a prisoner, the Environmental Physician should supply the questionnaire, directions for the physical and laboratory examinations, and the proper reporting forms. The registry examination contains no test unique to Agent Orange. It is essentially an evaluation of the veteran's health status. It will not determine whether a person was exposed to the herbicide or whether the veteran's body contains TCDD or the ingredients of Agent Orange. The results cannot be used per se to determine whether a given condition results from herbicide exposure. The Registry does allow the VA to provide later information to the veteran and is one means of identifying possible common consequences of service in Vietnam. �If the veteran is referred for a claimant's examination, the usual tests relevant to the complaint will be used. In addition, attention should be paid to examination of the skin, nervous system, muscular function, liver, kidneys, and mental status even when the claim is not directed to them. Questioning should attempt to uncover details of exposure to Agent Orange, to any adverse effects that are reported to have followed immediately after the exposure, and the time relation between later effects and exposure. When birth defect is claimed in an offspring, the obstetrical history of the spouse, including other births, should be elicited as well as familial histories of birth defects of both parents as should details including birth date and defects of the child in question. Confirmatory information from the obstitrician, pediatrician or other medical attendant should be sought. L. B. HOBSON 1/14/83 - 3- �7 - EPIDEMIOLOGY OF SOFT-TISSUE SARCOMA AND RELATED HUMAN RESEARCH -4. Initiation of Swedish Studies of Herbicides and Cancer In 1972 Swedish newspapers published rumors that railroad workers were dying from lung cancer as a result of exposure to herbicides used in their work. The National Board of Occupational Safety, as a result, requested Professor Olav Axelson, a specialist in occupational medicine, to undertake an epidemiological investigation of the matter. The results of this investigation have been reported in a series of four papers, J , £ Another series, .5-^7, was |-. prompted by criticism of "the" epidemiological and' "statistical methods employed in this and related studies.. Attention in the United States has focussed on the pre-publication manuscript of the 1980 paper by Axelson, Sundell, Andersson, Edling, Hogstedt, and Kling, 4. This paper dealt with two aspects of the study of railroad workers. The initial phase was a cohort study of 348 men who had been exposed, individually rather than as a group, to herbicides for more than 45 days during 1957 to 1972 and who were followed through October 1978. Exposure information was incomplete but the workers were divided into subcohorts with exposure to phenoxy acids (which include the ingredients of Agent Orange), amitrol, or to both herbicides. The mortality rates for these exposed subcohorts were compared to the age-specific national death rates for Swedish men, the latter serving as the control cohort. Overall 49 deaths were expected in the exposed cohort; 45 occurred, a result attributed to the "healthy worker effect." There were, however, 17 tumors found where 11.85 were expected. Among the deaths occurring at least ten years after the first exposure, 6 cancers were found although only 1.78 were expected. Dr. Axelson, £, later increased this to 7 tumor cases. Each subcohort had~~an excessive number of tumor deaths, the greatest being in the group exposed to both phenoxy herbicides and amitrol. Although initially, £, amitrol was associated with an increased tumor mortality^ somewhat different results were found in a second phase of the examination, described as a case-referent study (identical to a case-control study). The data indicated a "statistical association" of phenoxy herbicides and excess tumor mortality, ,3. Suspicion was increased by finding that workers exposed to phenoxy acids �alone had a-"statistically significant excess of stomach cancer", specifically 2 cases compared to 0.33 expected when this type of herbicide was used alone and 3 cases as compared to 5.1 expected (increased from 4.1, £) for all workers exposed to phenoxy herbicides, alone or with amitrol. The series of papers on railroad workers has been criticized on several methodological grounds, J9, and Axelson has replied to these criticisms, 6. Richard D. Remington, Dean of the School of Public HealtH, University of Michigan, reviewed this and other Swedish studies for the Office of Technology Assessment. His evaluation, 10, was that the Axelson investigations had been "carefully conducted" and "well reported." He pointed out the limitations of the statistical methods used and found that "the numbers available ... are inadequate to permit definite conclusions" although "the results ... are suggestive." Of interest in connection with the question of softtissue sarcomas and phenoxy herbicides is the type of tumors found by Axelson's group, jk One case of Hodgkin's lymphoma occurred among the eight tUmors in men exposed to phenoxy herbicides alone and no soft-tissue sarcomas or non-Hodqkin's lymphomas was diagnosed among the eight tumors appearing in workers exposed to both amitrol and phenoxy herbicides. In other words, no sarcomas were reported for the total of 207 men exposed to phenoxy compounds, J2. A reticulum cell sarcoma and a Hodgkin's lymphoma were found among the 7 tumors of workers exposed to amitrol alone. Thus, there was one soft-tissue sarcoma reported for 152 men exposed to amitrol, £• Another 28 persons described as exposed to "other herbicides and combinations" cannot be identified as to exposure to specific herbicides but apparently none developed a tumor. Axelson's work is directly related to the later work on soft-tissue sarcomas and lymphomas j2y-_LennarjL_Ha_rjd_e 1.1 • Indeed, Axelson suggested to Hardell in 1976, that he conduct a case-control study of soft-tissue sarcomas and has actively assisted in Hardell's work since then. Swedish Investigation of Soft-Tissue Sarcoma That work began when Hardell admitted for treatment 3 patients in the autumn of 1976, each with a soft-tissue sarcoma, and a history of exposure to phenoxy herbicides. He then found a total of 7 patients with "malignant mesenchymal tumors" (soft-tissue sarcomas) who gave a history of having worked with phenoxy herbicides 10 to 20 years earlier. The cases were among 87 patients with soft-tissue sarcomas, 55 of �whom were men. Of these men, 9 were forestry workers, 6 worked in forestry and on farms, and 6 were employed in saw mills or pulp plants. Another two tumors appeared in meni* whose connection with forestry was less direct. The malignancies found were two leiomyosarcomas, two rhabdomyosarcomas, two neurofibrosarcomas, with one each of fibroid liposarcoma, myxofibrosarcoma, and polymorphocellular sarcoma, 12, Following Axelson's advice, Hardell began a case-control study that was published in two journals, 13, 14, a common practice of reporting in Swedish with an almost identical paper in English. The second paper in English aroused much interest in the United States. Hardell and Sandstrom found 21 living and 31 dead men who were diagnosed as haying soft-tissue sarcomas in Hardell's oncology department in northern Sweden. They were matched for age and place of residence, as well as date of death for the deceased, with other men selected from the Swedish National Population Registry or from the National Registry for Causes of Death. Each living patient had 4 living controls; each dead man had 4 deceased controls. Exposure information was sought by the use of a mailed questionnaire that has never been published. It contained 130 questions, including 16 about the use of organic solvents, 4 about plastics, 3 about glues, 4 about drugs, "several" about smoking habits and an unstated number about exposure to phenoxy herbicides and chlorophenol as used in the lumber and paper mills. This questionnaire was mailed to the patient or to his next of kin if he were dead, 15. When the answers to the questionnaire were less than clear, a supplementary interview was obtained, usually by telephone, with the interviewer unaware of the health status of the person in question. Employers, neighbors, and others were consulted "if necessary to verify and monitor the accuracy of the exposure information," 15. Using the criteria for exposure established for the study, 36.5% of the 52 patients and 9.2% of the 208 controls had been exposed to phenoxy herbicides and/or chlorophenols. The "relative risk" of developing soft-tissue sarcomas was calculated as 5.7, i.e. men exposed to the chemicals had almost six times as great a change of developing a sarcoma as did those who were not exposed. The relative risk was 5.3 for the 46 men exposed to phenoxy herbicides alone, and 6.6 for the 40 men exposed only to chlorophenols. It was thought that confounding factors had an insignificant effect. JO -3 �The authors concluded that "the investigation showed an increased risk for soft-tissue sarcomas" but "a specific evaluation of the effect of separate chemical substances Was not possible," 14. The study's methods have been criticized and doubts have been expressed about the 100% response rate to the questionnaire approach, 9_. (Actually, 2 of 208 controls did not answer, 14.) The" statistical approach was described as slightly misrepresented and a major criticism was leveled because of the possibility of "selective recall," the greater tendency for an ill person to remember a supposed "cause" for the illness than a well person would have to remember the same "causal" event. The criticisms evoked several replies. Axelson defended the case-control design, the objectivity of obtaining exposure data retrospectively, and the statistical techniques, £. He concluded that the use of interviews for determining exposure is justified, T_, and defended in principle the treatment of confounding factors, 16. Hardell recalculated the 1979 results and his subsequent papers to substantiate his earlier findings and performed a separate investigation in support of his confidence that "no substantial observational bias could exist in the studies," 15. Remington, 10, expressed the view that "the findings of this particular Investigation are suggestive" and that "a relative risk of 5.3 for exposure to phenoxyacetic acids must be taken seriously." However, "case-control studies are uniquely susceptible to hidden sources of bias" even when the investigators are "unusually careful" as they are in this "excellent investigation." Hardell's group also undertook a second case-control study of identical design in southern Sweden which is more devoted to agriculture than to forestry, 17, 18. In this investigation each of 72 living and 38 de"ad~ patients was matched with two controls. Among the 110 cases, 22.7% reported exposure to phenoxy herbicides or chlorophenols and, among the 219 controls, 5.9% were so exposed. This gave a relative risk of 5.1 with matching and 4.7 when the matching was dissolved, i.e. when sorting by age was ignored during statistical calculations. The relative risk from exposure to phenoxy herbicides was calculated to be 6.8, and that from chlorophenols to be 3.3. Exposure to more than a dozen other noxious materials, e.g. asbestos, smoking, DDT, and lindane, were considered as possible confounding factors although none was found to be clearly associated with an increased risk by itself. �The reports list the diagnoses of all 110 cases of softtissue sarcoma as: leiomyosarcoma, 33; malignant fibrous •*.* histiocytoma, 19; liposarcoma, 15; neurogenic sarcoma, 11; angiosarcoma, 9; myxofibrosarcoma, 7; fibrosarcoma, 5; dermatofibrosarcoma, 3; atypical fibroxanthoma, synovial sarcoma, sarcoma NOS, 2 each; Ewings's sarcoma (extraskeletal) and rhabdomyosarcoma, 1 each. No statement is made as to which of these tumors was found in the 25 cases with identified exposures and no histological diagnoses are reported for the northern Swedish series, 13, ._14. The authors of the southern Swedish study conclude that "exposure to phenoxy acids and chlorophenols might constitute a risk factor in the development of soft tissue sarcomas," 18. The investigation has been the subject of the same criticisms and refutations as the earlier study. Remington concludes that "the results are consistent with the hypothesis that phenoxy acid exposure increases the risk of tumors of this type" but adds that "case-control methodology is intrinsically susceptible to subtle and unmeasurable biases." Swedish Investigation of Lymphoma In May, 1978, Hardell was prompted to a new study by a patient with a malignant histiocytic lymphoma and a history of "massive exposure to phenoxyacetic acids." All men admitted to the oncology department with this type of tumor during the first nine months of 1978 were asked about their occupation and possible chemical exposure. Of 17 patients, 14 reported an occupation consistent with exposure and 11 of them had had contact with phenoxy herbicides or chlorophenols ten or more years earlier, 19. These observations led to a case-control study, the report of which in 1981, 21, differs considerably from that in 1980, 20. The earlier report was commented upon in manuscript form by various experts but the later version will be used here. The investigation, in collaboration with Axelson, 20, included both Hodgkin's disease and non-Hodgkin lymphomas. The 169 cases consisted of 60 Hodgkin's disease patients (lymphocyte predominance, 20; nodular sclerosis, 3; mixed cellularity, 27; lymphocyte depletion, 10), 105 men with nonHodgkin's lymphomas (follicular center cell (FCC) type, 53; non-PCC type, 52), and 4 individuals with unclassifiable lymphomas. Each case had two matched controls, 338 in all. Of the cases, 62 had died as had 124 of the controls. �Questionnaires and interviews were used to determine exposure to-phenoxy herbicides, chlorophenols, organic solvents, or medicines and to characterize jobs, hobbies,-**nd smoking as they were determined in the soft-tissue sarcoma investigations, 20. All cases and controls were from northern Sweden. Cases in which exposure was reported to chlorophenol, or to "mutagenic" solvents (benzene, trichloroethylene, perchloroethylene and styrene) were divided into high-grade and lowgrade exposure groups. Continuous exp6sure for a week or less or repeated exposures totaling less than a month were considered low-grade. Analyses also divided cases into two groups depending on whether 5 years had elapsed as a latency period between the first exposure to the chemical and the tumor diagnosis. Of the cases, 36.1% had been exposed to phenoxy herbicides or chlorophenols; 9.6% of the controls had been so exposed. The relative risk for these exposures was 6.0 with matching and 5.3 without it. Phenoxy herbicides gave a relative risk of 4.8 although it was greater if exposure was for 90 days or more. Chlorophenols gave relative risks of 8.4 for high-grade exposure, 2.9 for low-grade. High- and lowgrade exposure to organic solvents gave relative risks of 2.8 and 1.2 respectively. On the other hand the few cases with both phenoxy herbicide and high-grade organic solvent exposure was calculated to have a relative risk of 11.2 and some other combinations also gave large relative risks. The length of the latency period, however, seemed to have no effect. The authors conclude that "this investigation suggests that exposure to organic solvents, chlorophenols, and/or phenoxy acids constitutes a risk factor for malignant lymphoma," 2j. Dr. Remington commented that "a substantial and statistically significant relative risk is found for this group of tumors. And again, pnenoxy acid exposure is specifically incriminated." He continues, however, that the limitations of case-control methods have to be considered as well. Swedish Investigation of Carcinoma of the Colon Rardell undertook to answer doubts that his questionnaire and interview methods allowed observational bias in assessing exposure by conducting a case-control study of "colon cancer." The condition is not suspected of having any association with phenoxy herbicides or chlorophenols. In consequence, if the previously used exposure determination �resulted in a relative risk of 1.0 or near it, there had been no observational bias in the questionnaire-interview procedure used in the earlier studies of soft-tissue sarcomas and lymphomas. Of the 157 men with colon cancer all but 3 answered the questionnaire. The controls consisted of the control groups from the soft-tissue sarcoma study (206 men) and the malignant lymphoma study (335 men). In allr 41% of the cases and 45% of the controls were dead. Of the cases and controls, 11.0 and 10.4% respectively had been exposed to phenoxy herbicides or chlorophenols. For phenoxy herbicides, the relative risk was calculated to be 1.3 and for chlorophenol it was 1.8. Neither was significantly above 1.0. The conclusion was that "the previously reported associations between exposure to phenoxy acids or chlorophenols and softtissue sarcoma and malignant lymphoma cannot to any essential degree be explained by observational bias," 15. Later Criticism of Swedish Studies There remain, however, doubts about the practical significance of the Swedish epidemiological studies stemming from several of their characteristics. The main criticism is the reliance on recall of the men or their relatives, employers and associates for undramatic events years earlier as well as the possibility of unconscious bias on the part of the interviewer, the "observational bias" discussed above. Coggan and Acheson point out that the positive association between exposure to phenoxy herbicides and the development of several or many softtissue sarcomas, Hodgkin's disease and non-Hodgkin's lymphoma may indicate "a serious undetected bias" even though the explanation has been offered that all these tumors are embryologically related, 22. These authors conclude that "it is as yet impossible" to estimate with any precision the risk of soft-tissue sarcoma due to phenoxy herbicides" but add that "there is suggestive evidence of a biological association between phenoxy herbicides (or their contaminants) and soft-tissue sarcomas." They feel that there is weaker evidence for an association between herbicides and lymphomas. Hardell and Axelson reject the idea of observational bias, citing the colon cancer study as evidence, 23. They also defend the aggregation of tumors because of the "so-called addition theorum for chi-square and Poisson distributions" as well as the embryological relationship of the neoplastic tissues. �American Support for Swedish Conclusions Support for the connection between soft-tissue sarcomas and exposure to phenoxy compounds has been reported in several papers from outside Sweden. The data most often cited as favoring the relationship are derived from observations in the American chemical industry.* The first was a note by Honchar and Halperin in which they pointed out that of 105 deaths in four exposed industrial "cohorts" 3 (2.9%) were due to soft-tissue sarcoma, whereas only 0.07% of deaths among adult American men are so caused. The three cases were malignant fibrous histiocytoma, fibrosarcoma, and liposarcoma. The authors felt that these "suggest a common pattern," 24. Cook added a fourth case, another malignant fibrousTTistiocytoma and noted that all four were smokers and two had chloracne, 25. Moses and Selikoff reported a fifth case, a non-smoker, with neurogenic sarcoma (malignant schwannoma). They give the total annual incidence of soft-tissue sarcomas as 4500 (less than 1% of newly diagnosed cancers) in the U.S. and quote 4.9% of soft-tissue sarcomas as malignant schwannoma, 26. Johnson and his co-workers briefly described a young man who died of fibrosarcomatous mesothelioma some four years after first being exposed to phenol. His father had a liposarcoma after "prolonged exposure" in a plant manufacturing chlorinated phenols among other chemicals, !• ! Hardell and Ericksson accepted the two additional cases to total 7 deaths from soft-tissue sarcoma among 105 deaths among American industrial workers, the expected number being 0.07%. This would "fit in with" the Swedish investigations, they believe, 28. To date no critical review has been made of the cases and the industrial population in which they were detected. The reports have been brief "Letters to the Editor" and each discusses one to three cases. The total of 105 deaths used as the number of dead workers has not been kept current as new soft-tissue sarcoma cases were added and the total number *Data given by Honchar and Halperin, Cook, Moses and Selikoff, and Johnson et al pertain to workers at Monsanto Company and Dow Chmical Company. For details of studies of these workers see 24a and 25a. 8 �of exposed workers has not been given. No use has been made of controls* even in the form of a retrospective cohort comparison. . ^ A case report without statistical data briefly described three soft-tissue sarcomas among Vietnam veterans who reported exposure to phenoxy herbicides in that country. One man had an inflammatory histiocytoma, another suffered from a fibrosarcoma, and the third had a leiomyosarcoma, 29. European Support for Swedish.Conclusions Barthel determined the frequency of malignant neoplasms among 1791 pesticide sprayers and agricultural technicians in Bast Germany during 1976 to 1979. He states the retrospective cohort study used police as controls but gives no data for them. After eliminating "on statistical grounds" 133 cases who died before 1970, he compared the mortality rate and cancer incidence with corresponding figures from the death statistics and the cancer registry of the Health and Social Welfare. The "case" group had multiple exposures over the years to fungicides, insecticides, and herbicides including phenocyacetic acids. Among 169 malignant neoplasms in 1658 exposed men were 1 lymphosarcoma, 3 plasmacytomas, 1 described as a malignancy of lymphoid tissue, and 1 of softtissue, not otherwise characterized. Bronchogenic carcinoma was the most common malignancy with 59 cases, double the expected occurrence, although the cases had smoking habits like those of the general population, 30. A brief report describes a case of non-Hodgkin's lympKoma and a second of malignant lymphoma among 158 workers with pentachlorophenol. This type of neoplasm would have an expected occurance of 0.28, 3U Stud ies Not Supporting SwedishConclus ions In contrast to the reports of an association between phenoxy herbicides or related compounds and soft-tissue sarcomas and malignant lymphomas, some investigators have found no association. Some of these investigated a possible relation, others were "follow-up" studies of industrial workers in whom no sarcomas or lymphomas were found. Dr. Riikimaki and his collaborators have completed nine years of mortality study following 1,926 persons who worked with phenoxy herbicides in Finland during the 1955-1971 period. All had at least two weeks of exposure and a quarter of the men totalled eight weeks or more as of 1971. The mortality rates among the workers were compared with the national death rates. As of 1980, there had been 82 deaths �of exposed men as compared to 91 expected and, of these, 17 were cancer^deaths with 18.4 expected. There were no cases of soft-tissue sarcoma nor of lymphomas although 0.1 and 0.8 would have been expected. The authors believe that "the .i? investigation cannot be regarded as a conclusive negative study" but point out that the "results do not confirm the ... association between mixed herbicide exposures" and cancer risk, 32. Hogstedt and Westerlund compared the mortality rate of Swedish supervisors and workers in forestry. The supervisors were fewer in number (142) than the workers (244) but the former were judged to have been more heavily exposed. The relative risk of death was about the expected but, after a 10-year latent period, the relative risk for cancer was about 4 for the supervisors and only about 0.4 for the workers. The fatal tumors were of various types but there was no softtissue sarcoma or lymphoma, 33. Two case-control studies in New Zealand have been initiated by Smith et al to examine the association suggested by Swedish studies of phenoxy herbicides with soft-tissue sarcomas and malignant lymphomas. In the first investigation, 102 cases of soft-tissue sarcoma have been identified in men from the New Zealand Cancer Registry between 1976 anjrfcJ 1980. An equal number of matched controls with other forms of cancer were selected for comparison. The sarcomas are fibrosarcomas, 25; liposarcomas, 20; rhabdomyosarcomas, 9; leiomyosarcomas, 7; malignant histiocytomas, 6; other types, 22; and unspecified, 13. The preliminary report compares cases and controls as to the occupation shown on the Registry enrollment. There was no significant difference betwen the groups as to the number of men working in agriculture, forestry, and fishing, the occupations with the greatest likelihood of exposure to phenoxy herbicides and chlorophenols. The only occupations associated with soft-tissue sarcomas exclusively are blacksmiths, machine tool operators, electrical fitters, and electrical workers. The investigators are now obtaining work histories for cases and controls by telephone interviews and warn that later results may change their conclusions. The data at present "do not give evidence for a relationship (of soft-tissue sarcoma) with occupational exposure to phenoxy herbicides and chlorophenols" but "should not be taken as substantive evidence against the hypothesis", 34. A second report by Smith et al includes the results of the telephone interviews regarding 80 cases and 92 controls already completed. Probable or definite exposure to phenoxy herbicides for more than one day earlier than five years before cancer registration was found in 17 cases and 13 con10 -/O �trols, giving an odds ratio of 1.6. This would be expected to increase when the exposure criteria were more stringent^ but, when exposure was at least five days and more than ten years before registration, there were 13 cases and 12 controls included reducing odds ratio of 1.3. Neither ratio is statistically significant and there have been no soft-tissue sarcomas reported among the most highly exposed group of 2000 aerial and ground sprayers. The results, the authors believe, "do not generally support the hypothesis that exposure to phenoxy acid herbicides cause soft-tissue sarcoma," 35. A brief initial report by Edling and Granstam compared the causes of death for 375 Swedish forestry workers, aged 25 to 69 years, who died during 1968 to 1977, with the mortality figures from the Swedish national statistics. There were 75 deaths from all malignant tumors, as compared to 86 expected. Renal tumors killed 8 with 3.84 expected and "tumors of lymphatic and hematopoetic systems" were responsible for 14 deaths with 7.5 expected. No deaths were attributed to softtissue sarcoma, 36. In addition to these studies, several small industrial groups have been followed well into the latent period for solid tumors. None has been reported to include cases of soft-tissue sarcoma or malignant lymphoma. May examined 41 of 79 workers who developed chloracne following accidental exposure to trichlorophenol in 1968 at the Coalite Company in Great Britain. Another 54 employees were possibly exposed. None of the workers had significant changes ten years after the accident and neither death from nor evidence of neoplasm was found, 37. Jirasek's group has closely followed 55 men who were intensely exposed during the manufacture of 2,4,5trichlorophenoxyacetate from 1965 to 1968 in Spolana, Czechoslovakia, and who developed evidence of acute intoxication. Two workers died of bronchogenic carcinoma 5 to 5.5 years after the first exposure. There was no other evidence of malignant neoplasms during a ten-year follow-up, 38. In 1963 an explosion at Philips-Duphar, Amsterdam, exposed 106 workers involved in manufacturing 2,4,5-tetrachlorophenyoxy acewtate. Among the 93 workers followed to 1977, only one death 14 months after the accident was due to cancer and the pancreatic carcinoma involved was apparently symtomat ic before the explosion. No case of soft-tissue sarcoma or malignant lymphoma was reported, 39. One study is often cited with the Swedish studies although it did not deal with soft-tissue sarcomas and malignant lymphomas, 40. A more recent review by Thiess et al reports that all"T4 exposed persons are still being followed �after 26 years. There have been 21 deaths, about equal to the 18 to 20 deaths expected from major comparative populations and 18 and 19 deaths expected among matched unexpos«*d controls. Cancer was responsible for 7 deaths as compared to 4.1 expected from the comparative populations and 5 in each internal control group. Gastric carcinoma in 3 exposed persons exceeds the expected 0.61 to 0.70 expected cases. There were, however, no soft-tissue sarcomas or malignant lymphomas among these chemical workers at BASF, 41. A number of other industrial exposures to phenoxy herbicides, their precursors or contaminants were reported before 1973, 42. The populations were small but generally heavily expose'ST Unfortunately it has not been possible to locate late reports on the exposed populations although ten years or more have elapsed since exposure. The accident at the ICMESA factory in Seveso, Italy, in July \9.76 exposed many people to trichlorphenolj more than 5400 adults and children of both sexes are known to have been in contact with the chemicals for several days, 43. Although only about six years have elapsed since the exposure, the population has been under surveillance and the rate and causes of death are being followed. To date no soft-tissue sarcomas or malignant lymphomas have been reported. Another less systematic observation bears on the situation. The phenoxy herbicides have been used frequently and extensively in agriculture and forestry in the United States since the late 1940's. They were used on lawns in cities, as well, for most of that period. If the relative risk of developing so distinctive a group of tumors as the soft-tissue sarcomas and the malignant lymphomas had increased by 5 of 6 fold over that before 1945 as the Swedish studies would predict, it almost certainly would have been evident to clinicians and pathologists, especially in the rural areas, even without systematic studies. No such increase was noted. Critical Evaluations The Swedish investigators have been cautious in interpreting their results, in his medical dissertation based on his epidemiological studies, Hardell judges that the similar results in the two case-control investigations (12, 13, 14, 16) "seem to increase the confidence that the observe? assocTation of exposure to phenoxy acids and soft-tissue sarcoma was not spurious" and did not believe that confounding factors "could account for the observed relation." In summary, he concluded that "it is suggested that exposure to phenoxy 12 �acids should be looked upon as an occupational cancer hazard," 44". •v Other reviewers have been more skeptical as to the significance of the work. Remington's overall opinion was that "in totor the Swedish work is credible if not fully conclusTv~e. Certainly this work would seem to justify further investigation," 10. Coggan and Acheson, after reviewinq other work as weTT as the Swedish studies, state that "on the present evidence it seems possible that soft-tissue sarcomas have arisen in association with exposure to phenoxy herbicides" but continue that "it is as yet impossible to estimate with any precision the risk of soft-tissue sarcoma due to phenoxy herbicides." They conclude that "there is suggestive evidence of a biological association between phenoxy herbicides (or their contaminants) and soft-tissue sarcoma. The evidence relating these products to the occurance of lymphoma is' weaker," 22. An unsigned editorial in Lancet commenting on the opinions of Coggan and Acheson seems to agree with their conclusions with regard to soft-tissue sarcomas, 45. Hardell and Axelson disagreed with both the Coggan and Acheson's opinions and the Lancet editorial, 23. They have been at some pains to counter charges o!T""observational bias," 15, but have not convinced everyone that faulty memories do not result in significant errors in evaluating exposure, 45. The causal connection between phenoxy herbicides and soft-tissue sarcomas would be much more likely if there were a unique preponderance of one type or even of a few types in the exposed men. The Swedish reports never compare the morphological types or location of the malignant tumors in cases with those in controls, 45. Their only justification for aggregating the types, and presumably for omitting the data from their reports is "the uncertainty of relations between the various histological groups in terms of causal mechanisms" and "the so-called addition theorem for chi-square and Poisson distribution," 23. The uncertainty of causal relations is precisely" the reason for reporting the groups and the addition theorem cannot justify the aggregation of unlike *2,3,7,8-tetrachlorodibenzo-p-dioxin has been suggested as the principal carcinogen in the phenoxy herbicide 2,4,5-T and trichlorophenols but this has been disputed. See 22, 23, 45, 46. The controversy is not considered in tTTTs cfTscussion. 13 �entities tut-less significant common factors have been demonstrated. <> •». Scientific results are strengthened greatly when independent investigators substantiate them. The Swedish studies have been said to be independent and confirmatory. The two soft-tissue sarcoma investigations do support one another (12, 13, JU, 16) but they are the work of the same group ofTnvestigators. The investigation of malignant histiocytic lymphoma- was also conducted by the same group but was a case-control study of a separate entity, n^-21). Axelson's work on herbicide exposure and cancer ( - . was not truly independent from T4) Hardell's efforts since~~Hardell has recognized his indebtedness to Axelson for his assistance in the first case-control study, (13, 14). More important Axelson did not associate phenoxy"TierbTcides or chlorophenolic compounds with soft-tissue sarcomas nor with malignant lymphomas among railroad workers, J_-j4. The reports of soft-tissue sarcomas among chlorphenol workers in the United States (jJ4_-27) have been cited as supporting Hardell's conclusions ,""2*4, 28, 44, 46. The data have been reported piecemeal without a clearly enumerated total population from which they were drawn. The comparison was made to mortality data for the general population of the appropriate age and sex. The type of soft-tissue sarcoma is known for each case; among the 7 men were 2 malignant fibrous histiocytomas, 2 liposarcomas, as well as one each of fibrosarcoma, malignant schwannoma, and fibrosarcomatous mesothelioma. As before, the tumors are not of a uniform type. Coggan and Acheson comment that the Swedish studies and the American reports taken separately do not "provide convincing evidence that the incidence of soft-tissue sarcomas is increased after exposure to phenoxy acids and chlorophenols, — Considered together the whole becomes more persuasive." They add that "it is surprising that the association should apply to tumors of such a variety of tissues," 22. The Lancet editorial finds only that "the number of cTeaths due to soft-tissue sarcomas [in the American data] is disturbing," 45. In addition to the American experience, the British (37), European (.30, 32± 33, 36, .38-41) and New Zealand (34, 3*57 medical and scientifTc writers Have studied populations TTve years or longer after exposure to phenoxy herbicides and/or chlorophenols in a variety of situations, some intense and acute, others prolonged. Only one observer (30) reported a case described as a soft-tissue malignant neoplasm without 14 �further characterization. The same report included a lymphosarcoma, a malignant neoplasm of lymphoid tissue and 3 plasmocytomas. No other study found a soft-tissue tumor.'•*» In summary, the Swedish studies of soft-tissue sarcomas cannot be considered to have proved that exposure to phenoxy herbicides is the cause of one or more types of this varied group of malignant tumors. There are no fully reported systematic studies to confirm what the Swedish investigators describe as an association. There are an epidemiological study (32) and observations of exposed, populations that do not support the finding as opposed to uncorrelated American observations and an East German study (30) that do strengthen the case for such an association. At best, the Scottish verdict of "Not proven" seems most realistic at this time. The Advisory Panel on Toxic Substances of the American Medical Association says that "while 2,4,5-T and 2,4-D pesticides (phenoxy herbicides in Agent Orange) have been used in agriculture, forest management and residential landscaping for over 30 years, there is still no conclusive evidence that they and/or TCDD (a contaminant of Agent Orange) are mutagenic, carcinogenic, or teratogenic in man, nor that they have caused reproductive difficulties in the human," 47. 15 �BIBLIOGRAPHY 1. Sundell, L., Rehn, M., and Axelson, 0. Exposure to herbicides - mortality and tumor incidence. An epidemiological investiqation in Swedish railway workers. Lakartidningen 71:2466-2470. 1974 2. Axelson, O. and Sundell, L. Herbicide exposure, mortality, and tumor incidence. -An epidemiological investiqation on Swedish railroad workers. Work Environ". Health 11:21-28. 1974 3. Axelson, 0. and Sundell, L. Phenoxy acids and cancer. Lakartidningen 74:2887-88. 1977 4. Axelson, 0., Sundell, L., Andersson, K., Edling, C., Hogstedt, C., and Kling, R. Herbicide exposure and tumor mortality. An updated epidemiological investigation on Swedish railroad workers. Scand. G. Work Envirn. & Health 6:73-79. 1980 5. Axelson, 0. Aspects on confounding in occupational health epidemiology (Letter.) Scand. J. Work* Environ. & Health 4:85-89. 1978 6. Axelson, 0. Views on criticism of pesticide studies (Reply to note by Jannerfeldt, E.). Lakartidningen 77(12):1096-1099. 1980 7. Axelson, 0. A note on observational bias in case-referent studies in occupational health epidemiology. Scand. J. Work Environ. & Health 6:80-82. 1980 8. Axelson, 0. Testimony before EPA Hearing, EPA Exhibit No. 587. 1980 9. Jannerfeldt, E. Epidemiologic methodology and pesticide studies. Lakartidningen 77(12): 1096. 1980 10. Remington, R. D. Specific summary critique of five investigations related to concerns about Agent Orange. Congressional Record, pp. S 10911, S 10912, August 6, 1980. 11. Hardell, L. Verbal testimony at EPA Hearing. September 29, 1980. �12. Hardeil, L. Malignant mesenchymal tumors and exposure to phenoxy acids - A clinical observation. •<. Lakartidningen 74(33):2753-2754. 1977 13. Hardeil, L. and Sandstrom, A. Malignant mesenchymal soft tissue tumors and exposure to phenoxy acids or chloramphenacol. Lakartidningen 75:3535-3536. 1978 14. Hardell, L. and Sandstrom, A. Case-control study: Soft tissue sarcomas and exposure to phenoxyacetic acids or chlorophenols. Brit. G. Cancer 39:711. 1979 15. Hardell, L. Relation of soft-tissue sarcoma, malignant lymphoma and colon cancer to phenoxy acids, chlorophenols and other agents. Scand. G. Work Environ. & Health 7(119-130). 19B1 16. Axelson, 0. Aspects of confounding and effect modification in the assessment of occupational cancer risk. J. Toxicol. & Environ. Health 6(5-6):1127-1131. 1980 17. Eriksson, M., Hardell, L., Berg, N. 0., Moller, T. and Alexson, 0. Case-control study of malignant mesenchymal tumors of the soft tissue and exposure to chemical substances. Lakartidningen 76:3872-3875. 1979 18. Eriksson, M., Hardell, L., Berg, M. 0., Moller, T., and Axelson, 0. Soft-tissue sarcomas and exposure to chemical substances: a case-referant study. Brit. J. Industr. Med. 38:27-33. 1981 19. Hardell, L. Malignant lymphoma of histiocytic type and exposure to phenoxyacetic acids or chlorophenols. Lancet 1(8106):55-56. 1979 20. Hardell, L., Erikson, M., Lenner, P. Malignant lymphoma and exposure to chemical substances, especially organic solvents, chlorophenols and phenoxy acids. Lakaridningen 77(4):208-210. 1980 21. Hardell, L., Erikson, M., Lenner P., and Lundgren, E. Malignant lymphoma and exposure to chemicals, especially organic solvents, chlorophenols and phenoxy acids: a case-control study. Brit. J. Cancer 43:169. 1981 �22. Coggon, D. and Acheson, E. D. Do phenoxy herbicides cause cancer in man? Lancet 1(8278)1057-1059. 1982 -v. 23. Hardell, L. and Axelson, 0. Soft-tissue sarcoma, malignant lymphoma, and exposure to phenoxy acids on chlorophenols. Lancet 1(8286):1408-1409. 1982 24. Honchar, P. A. and Halperin, W. E. 2,4,5-T, trichlorophenolr and soft-tissue sarcoma. Lancet 1(8214):268-269. 1981 24a. Ott, M. G., Holder, B. B., and Olson, R. D. A mortality analysis of employees engaged in the manufacture of 2,4,5-trichlorophenoxyacetic acid. J. Occup. Med. 22:47-50. 1980 24b. Cook, kR. R., Townsend, J. C., Ott, M. G., and Silverstein, L. G. Mortality experience of employees exposed to 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD). J. Occup. Med. 22:530-532. 1980 25. Cook, R. R. Dioxin, chloracne, and soft-tissue sarcoma. Lancet 1(8220)618-619. 1981 25a. Zack, J. A. and Suskind, R. R. The mortality experience of workers exposed to tetrachlorodibenzodioxin in a trichlorophenol process accident. J. Occup. Med. 22:11-44. 1980 25b. Zack, J. A. A mortality study of workers employed at the Monsant Plant in Kitro, W.Va. Unpublished. 26. Moses, M. and Selikoff, I. J. Soft-tissue sarcomas, phenoxy herbicides, and chlorinated phenols. Lancet 1(8234):1370. 1981 27. Johnson, F. E., Kugler, M. A., and Brown, S. M. Soft tissue sarcomas and chlorinated phenols. Lancet 2(8236):40. 1981 28. Hardell, L. and Erikson, M. Soft-tissue sarcomas, phenoxy herbicides and chlorinated, phenols. Lancet 2(8240):250. 1981 29. Sarma, P. R. and Jacobs, G. Thoracic soft-tissue sarcoma in Vietnam veterans exposed to Agent Orange. New Engl. J. Med. 306(18) :1109. 1981 �30. Barthel, E. Cancer risk in agricultural workers exposed to pesticides. Arch. Geschwulstforsch. 51(7):579-585. 1981 t ••> 31. Bishop, C. M. and Jones, A. H. Non-Hodgkin's lymphoma of the scalp in workers exposed to dioxin. Lancet 2(8242):369. 1981 32. Riikimaki, V., Asp, S., and Hernberg, S. Mortality of 2,4-dichlorophenoxyacetic acid and 2,4,5-trichlorophenoxyacetic acid herbicide applicators in Finland. Scand. J. Work Environ. & Health 8:37-42. 1982 33. Hoqstedt, C. and Westerlund, B. Cohort study of mortality rates of.forestry workers with and without exposure to phenoxy compounds. (No translation available) Lakartidningen 77(19):1828-1830. 1980 34. Smith, A. H., Fisher, P. O., Pearce, N. and Teague, C. A. Do agricultural chemicals cause soft-tissue sarcoma? Initial findings of a case-control study in New Zealand. Unpublished report at ANZSEARCH Annual Conference, May, 1982 35. Smith, A. H., Fisher, D. O., Giles, H. J., and Pearce, N. The New Zealand soft-tissue sarcoma case-control study: interview findings concerning phenoxyacetic acid exposure. Unpublished report at Third International Symposium on Chlorinated Dioxins and Related Compounds. October 1982 36. Edling, C. and Granstam, S. Pattern of causes of death among forestry workers, a pilot study. Hygiea 88(3):74. 1979 37. May, G. Tetrachlorodibenzodioxin: a survey of subjects ten years after exposure. Brit. J* Industr. Med. 39:128-135. 1982 38. Pazderova-Vejlupkova, J., Nemcova, N., Pickova, J., Lukas, E., and Jirasek, L. The development and prognosis of chronic intoxication by tetrachlorodibenzo-dioxin in man. Arch. Environ. Health 36(1):5-11. 1981 �39. Cited in Huff, J. E., Moore, J. A., Saracci, R. and Tomatls, L. Long-term hazards of polychlorinated dibenzodioxins and polychlorinated dibenzofurans. •>><• Environ. Health Prespectives 36:221-240. 1980; and Hay, A. Accidents in trichlorophenol plants: a need for realistic surveys to ascertain risks to health. Ann. N.Y. Acad. Sci. 320:324. 1979 40. Thiess, A. M. and Frentzel-Beyme, R. Mortality study of persons exposed to dioxin following an accident which occurred in the BASF on November 13, 1953. Presented at the Fifth International Conference on Medichem. September 1977 41. Thiess, A. M., Frentzel-Beyme, R., and Link, R. Mortality study of persons exposed to dioxins in a trichlorophenol process accident that occurred in the BASF AG on November 17, 1953. Am. J. Industr. Med. 3:179-189. 1982 42. Young, A. L., Calcagni, J. A., Thalken, C. E., and Tremblay, J. w. The toxicology, environmental fate, and human risk of Herbicide Orange and its associated dioxin. USAF OEHL Technical Report (Report OEHL TR 78-92) pp. V-7, V-8 43. Caramaschi, F., del Corna, G., Favaretti, C., Giambelluca, S. E., Montesarchio, E., and Fara, G. M. Chloracne following environmental contamination by TCDD in Seveso, Italy. Intern. J. Epidemiol. 10{2):135-143. 1981 44. Hardell, L. Epidemiological studies on soft-tissue sarcoma and malignant lymphoma and their relation to phenoxy acid or chlorophenol exposure. Umea University Medical Dissertations, New Series No. 65. 1981 45. Anonymous. Phenoxy herbicides, trichlorophenols, and soft-tissue sarcomas (Editorial). Lancet 1(8278):1051-1052. 1982 46. Hardell, L. and Axelson, 0. Phenoxy acids, chlorophenols, and cancer. Lakartidningen 78(34):2862-2863. 1981 47. Council on Scientific Affairs' Advisory Panel on Toxic Substances (American Medical Association). The health effects of "Agent Orange" and polychlorinated dioxin contaminants. October 1, 1981 �PORPHYRIA OJTANEA TRRDA LAWRENCE B. HDBSON, M.D., Ph.D. Deputy Director Agent Orange Projects Office Veterans Administration April 1983 J/-/ �PORPHYRIA CUTANEA TARDA Definition : Porphyria cutanea tarda (PCT) is the most frequent of a group of uncommon diseases, the porphyrias, that comprise disturbances in the body's formation of hemoglobin, the red chemical in blood. A specific pattern of chemicals called porphyrins, excreted in the urine and stool, characterizes PCT and reflects a deficiency of one of the liver's enzymes involved in hemoglobin formation. The disease manifests itself in the skin where small and large blisters form on the exposed parts of the body, probably as a slow response to sunlight. The skin becomes very fragile and easily rubs off to produce sores that scab over and sometimes leave scars. PCT appears to be inherited, at least in some cases, but exposure to some chemical or other external factor is required before it becomes manifest. ( 1 . . .-4) Clinical Manifestations; PCT is usually first noticed when small or large blisters appear on the face, the back of the hands, and the arms usually following exposure to sunlight many hours or days earlier. This contrasts with the prompt reaction to sunlight in other porphyrias. The skin slowly becomes so fragile that even slight rubbing strips off the top layer leaving an open shallow sore that scabs over and heals slowly. The thin skin that forms in the area gradually returns to normal over months. It may instead scar permanently or, in severe cases, may progressively stiffen and thicken until it resembles another skin disease, scleroderma. (J5, 6_) In a few very severe cases, the skin changes have resulted in th~e loss of parts of the nose, ears or fingers. Hair, especially around the temples and upper cheeks, may grow dark and prominent. (T) The skin may darken or may lighten abnormally in the affected areas. (B) Small "white heads" sometimes appear before or after blistering. The porphyrins in the urine often give it a pink, dark red or brown color. They fluoresce red in ultra-violet light, a phenomenon that assists in diagnosing PCT. (30 Several methods of treating PCT are available, the most frequently used being repeated bleeding, and the disease is more successfully treated than are other porphyrias. The most important measure, however, is the avoidance of any chemical or other factor that precipitated the attack. (±, 2) The time it takes the patient to recover seems to depend upon how severely the body was damaged. The skin changes disappear first, usually within 6 months when even severe cases are treated. ( , 10) The disturbance of the body's chemistry clears up in £ �about a yeaj:. In less severe cases, simply avoiding contact with the causative chemical or other external factor is followed by complete recovery within a year. (11) Children who developed PCT after prolonged and intensive exposure when they ate seed grain treated with a chemical were very ill and had scarring, hairiness/ arthritis and stunted growth even 20 years later. (12) PCT is usually accompanied by some liver damage and in 4 percent or more of the patients a particular form of liver cancer develops. (I) It is difficult to determine whether the liver is damaged by PCT or by alcoholism which often precipitates the porphyria. Causes; At present, PCT is thought to have two causes: heredity and external factors. There is little agreement on the relative role of these two or on exactly how they interact. Heredity: There is good evidence that some cases of PCT have a hereditary basis. This has been demonstrated by finding, in healthy blood relatives, the same chemical defects as appear in patients although the changes are less severe in the well relatives. (13 - 16) The few available studies (16, 17) indicate that 6 to 10 percent of the general population have the hereditary defect; most never develop obvious PCT. The various family studies show that PCT is inherited as what geneticists call an "autosomal dominant gene." (13 - 16) This gene decreases the liver's ability to produce an enzyme called "uroporphyrinogen decarboxylase" that is essential for the normal production of hemoglobin. A deficiency of this enzyme can result in the appearance in the urine of unusually large amounts of substances called "uroporphyrins" as well as related changes in the body's chemistry. (!_ - 4,) The situation is more complicated, however, than this suggests. Not all persons who have the hereditary defect develop PCT and not all persons with PCT have evidence of the hereditary defect. It apparently requires exposure to some other factor, generally an environmental one, to produce the disease prophyria cutanea tarda even in the presence of the hereditary defect. External Factors: A wide variety of chemicals, diseases, and even bodily states can disturb the liver's ability to bring about normal chemical reactions in the formation of hemoglobin and so produce one or another type of prophyria. (18) Some- of these changes are relatively slight and transient; others are more serious and longer lasting. i The chemicals that produce, PCT have been divided by some investigators into two categories: those that trigger attacks in �people witsh the hereditary enzyme defect and those that produce the disease in people without the defect. The chemical hexachlorobenzene is roost often given as an example of a substance that produces PCT in anyone. This is largely because 4000 people in rural Turkey who ate, over several winters, seed grain treated with the chemical developed attacks of PCT that were often severe and protracted. (12) Relatively large doses of the female hormone estrogen is said to produce PCT only when the hereditary defect is present. (2) The interaction of hereditary and external factors is still not understood but it is important in several situations, two of which are alcoholism and exposure to TCDD or dioxin. Chronic alcoholism is unquestionably the most common precipitating factor producing PCT among the populations of North America and Europe where about 68 percent of PCT patients are alcoholic. (19) The alcoholic patients who develop PCT, however, have often not been so impaired by their drinking that they could not hold jobs. Alcohol abuse has many deleterious effects, of course. Among them are the storage of an excessive amount of iron in the liver and the production of various liver changes culminating in hepatic cirrhosis. Both of these changes are associated with PCT but exactly how they are related to it is not clear. (I) While alcoholism is common among PCT patients only about 2 percent of alcoholic patients with cirrhosis develop uroporphyrinogen decarboxylase deficiency and PCT. (20) This suggests that a hereditary defect probably plays a part in the appearance of PCT in alcoholics. TCDD or dioxin (2,3,7,8-tetrachlorodibenzo-p-dioxin) has been implicated as the cause of PCT in only two industrial episodes, both involving prolonged contact with large amounts of the chemical. In both instances, the workers were exposed to other chemicals as well. At the Diamond Chemical plant in New Jersey that manufactured chemicals containing TCDD, 55 men were examined in 1963 when 3 workers were found to have had the skin and hair changes of PCT and to pass urine containing uroporphyrin. When no longer in contact with TCDD, one man recovered completely within a year and another had recovered during a two-year period. The third had only some scars a year after being removed from contact with TCDD. Another 11 men had uroporphyrin in their urine without skin changes. Of the 55 men, 17 had the other skin disease, chloracne, indicating exposure to TCDD or a related chemical but there was no relationship between the occurrence of PCT and of chloracne. (21) I Six years after the initial examination, a second group of doctors examined 73 men working at the same New Jersey plant which �had taken steps to protect its employees from exposure to TCDD after the earlier episode. No PCT was found and only one worker continued to pass uroporphyrin. Some men still had slight to moderate chloracne, however, (22) The second industrial episode involved intense exposure to similar chemicals, including TCDD, between 1965 and 1968 in a manufacturing plant in Czechoslovakia. In all, 80 of 400 workers became ill. (23) A total of 78 developed chloracne as evidence of contact with TCDD or pentachlorophenol .both of which were present. Twelve workers, more than half of them over 40 years of age, were diagnosed as having PCT. One man is said to have been exposed to the chemicals for only two and a half weeks before he developed PCT and in one patient porphyria is reported to have progressed rapidly into hardening of his brain's arteries. (24) Neither the rapid onset nor the progression to arterial hardening is known to occur in PCT. Among 55 workers examined repeatedly, 11 persistently had large amounts of uroporphyrin in the urine; 12 others intermittently passed large amounts. These values gradually decreased during a four-year period. Of the 11 workers with a heavy output of porphyrin, 10 had the usual skin changes of PCT. (25) The patients knew of no porphyria in members of their families and the researchers were unable to determine whether any of the men drank excessively. (26) In 1974, the doctors reported that the amount of uroporphyrTn in the urine had been greatest in 1969 but had returned to normal as the skin changes improved. After 9 years of observation excessive excretion of uroporphyrin and skin manifestations were "exceptional" occurrences. (27) A year later such abnormalities were said to be "very rare." (23) In addition to these two incidents of PCT as a consequence of exposure to high concentrations of TCDD, other researchers have described a less severe and completely non-symptomatic change in the liver's enzyme performance following the industrial accident at Seveso, Italy in 1976. Two years after the accident the amount of porphyrins in the urine was normal but the types excreted showed minimal changes in 84% of the people examined. This may indicate that TCDD has an effect but it did not indicate that the people had any disease. (28) To make matters more complicated two related persons who lived near Seveso were found to have PCT. Examinatipn' of 66 family members demonstrated, however, that the two were suffering from the hereditary form of PCT. (29) It raises the possibility that TCDD as an environmental factor may have enabled the hereditary enzyme defect to exert its adverse effect. �Treatment:_ The most important therapeutic and preventive measure for PCX patients is the avoidance so far as possible of further contact with the external factor or factors that precipitate the attacks. This is critical whether alcohol, estrogen, polychlorinated biphenyls (PCBs), hexachlorobenzene, certain drugs, TCDD, or other factors are involved. The usual active treatment is repeated bleeding. In most patients with severe PCT there are excessive iron stores, especially in the liver. Judicious bleedings, as in blood donations, remove this iron and improve the patient's condition. There are medications that can be used to reduce the body's iron stores although generally they are not as safe as bleeding. Untreated, the disease grows worse year by year if the external factors are not removed. Eventually the liver becomes seriously damaged. Removal of the external cause, however, expecially after a single or a few relatively brief contacts, is followed by slow but progressive improvement with apparent recovery. (30) Agent Orange asExternal Factor; Since one component of Agent Orange contained small amountsof TCDD, it has been suggested that the herbicide acted as an external factor to cause porphyria cutanea tarda, with persistence of the condition to produce continuing trouble at the present time. This seems unlikely for several reasons. PCT is a skin problem with a dramatic appearance and under conditions of combat in Vietnam would probably have been incapacitating, unlike chloracne which would have been relatively inconspicuous in most cases. In New Jersey and Czechoslovakia, the only two episodes where TCDD is known to have produced PCT, the skin changes were readily noticed. The industrial exposures to TCDD causing PCT were intense and prolonged, lasting several years for most of the workers. Troops in Vietnam were exposed to much less TCDD. Recovery from PCT usually follows removal from contact with the external cause within five years. The last contact with Agent Orange in Vietnam was ten years ago. There are current external factors much more lik.ely than Agent Orange exposure a decade or more ago to cause- attacks of PCT at present. Among them are various medications, PCBs and alcoholism, none of them rare in America today. They should be eliminated from consideration as the precipitating factor before Agent Orange is accepted as a cause of PCT in any individual. L. B. Hobson April 11, 1983 �BIBLIOGRAPHY 1. Kappas, A., Sassa, S., and Anderson, K. E. The porphyrias, pp. 1301-1384 in "The Metabolic Basis of Inherited Disease," Fifth Edition, by J.B. Stanbury et al., McGraw Hill, N.Y. 1983 2. Tschudy, D. P. and Laman, J.M. Porphyrin metabolism and the porphyrias, pp. 939-1007 in "Metabolic Control and Disease," Eighth Edition by P. K. Bondy and L. E. Rosenberg, W. B. Saunders, Philadelphia. 1980 3. Sherlock, S. "Diseases of the liver and Biliary System," Sixth Edition, Blackwell, Oxford. 1981 4. Leevy, C. M., Popper, H., and Sherlock, S. "Diseases of the Liver and Biliary Tract. Standardized Nomenclature, Diagnostic Criteria, and Doagnostic Methodology," York Book, Chicago. 1976 5. Harber, L. C. Porphyrea cutanea tarda, Unit 12-15 in "Clinical Dermatology" by J. Demis et al. Harper and Row, Hagerstown. 1975 6. Epstein, J. H., Tuffanelli, D. L. and Epstein, W. L. Cutaneous changes in porphyrias, Arch. Dermat. 107:689-695. 1973 7. Bickers, D. R., Pathak, M. A. and Magnus, I. A. The porphyrias, pp. 1072-1105, in "Dermatology in General Medicine," Second Edition by T. R. Pitzpatrick et al., McGraw Hill, New York. 1979 8. Muhlbauer, J. E. and Pathak, M. A. Porphyria cutanea tarda. Intern. J. Dermatol. 18(10):767-780. 1979 9. Grossman, M. E., Bickers, D. R. Poh-Fitzpatrick, M. B., Deleo, V. A. and Haber, I. C. Porphyria cutanea tarda: clinical features and laboratory findings in 40 patients. Am. J. Med. 67:277-286. 1979 10. Haberman, H. F., Rosenberg, F., and Menon, I. A. Porphyrea cutanea tarda: comparison of cases precipitated by alcohol and estrogens. Can. Med. Assoc.'J. 113:653. 1975 �11. Lynch, R. E., Lee, G. R., and Kushner, J. P. PorpKyria cutanea tarda associated with disinfectant misuse. Arch. Intern. Med. 135:549-552. 1975 12. Cripps, D. J., Gocman, A., and Peters, H. A. Porphyria turcica twenty years after hexachlorobenzene intoxication. Arch. Dermatol. 116:46-50. 1980 13. deVerneuil, H., Aitken, G. and Nordman, Y. Familial and sporadic porphyria tarda: two different diseases. Human Genetics 44:145-151. 1978 14. Kushner, J. P., Barbuto, A. J., and Lee, G. R. An inherited enzymatic defect in porphyria cutanea tarda. J. Clin. Invest. 58:1089-1097. 1976 15. Elder, G. H., Sheppard, D. M., deSalamanca, R. E. and Olmos, A. Identification of two types of porphyria cutanea tarda by measurement of erythrocyte uroporphyrinogen decarboxylase. Clin. Sci. 58:477-484. 1980 16. Lehr, P. A. and Doss, M. Chronische hepatische Porphyrie mit Uroporphyrinogen-Decarboxylase-Defekt in vier Generationen. Dtsch. Med. Wschr. 106:241-245. 1981 17. Strik, J. J. T. W. A., Doss, M., Schraa, G., Robertson, L. W., von Tiepermann, R., and Harmsen, E. G. M. Coproporphyria and chronic hepatic porphyria type A found in farm families from Michigan exposed to polybrominated phenols (PBB), pp. 29-53 in "Chemical Porphyria in Man" by Strik, J. J. T. W. A. and Koeman, J. H. Elsevier/North-Holland, Amsterdam. 1979 18. Doss, M. Pathobiological transition of secondary coproporphyrinuria to chronic hypatic porphyria in humans. Klin. Wschr. 58:141-148. 1980 19. Malina, L. and Chlumsky, J. The problem of possible etiological factors in the origin and development of PCT. pp. 117-120 in "Diagnosis and Treatment of Porphyrea and Lead Intoxication" by M. Doss,. Springer-Verlag, Berlin. 1978 �20. Haellen, J. and Krook, H. Follow-up studies on an unselected ten year material of 360 patients with liver cirrhosis in one community. Acta Med. Scand. 173:479. 1963 21. Bleiberg, J., Wallen, M., Brodkin, R. and Appelbaum, I. L. Industrially acquired porphyria. Arch. Dermat. 89:793-797. 1964 22. Poland, A. P., Smith, D.f Metter, G., and Possik, P. A health survey of workers in a 2,4-D and 2,4,5-T plant. Arch. Environ. Health. 22:316-327. 1971 23. Pazderova-Vejlupkova, J. Lukas, E.r Nemcova, M., Pickova, J. and Jirasek, L. The development and prognosis of chronic intoxication by tetrachlordibenzo-p-dioxin in men. Arch. Environ. Health. 36:5-11. 1981 24. Jirasek, L., Kalensky, J. and Kubec, K. Occurance of chloracne and porphyria cutanea tarda during the production of herbicides. Cesk. Dermatol. 48:306-317. 1973 25. Jirasek, L., Kalensky, J., Kubic, K.,. Pazderova, J. and Lukas, E. Chloracne, porphyria cutanea tarda, and other manifestations of general intoxication during the manufacture of herbicides, II. Cesk. Dermatol. 49:145-147. 1974 26. Pazderova, J., Lukas, E., Nemcova, M., Spacilova, M., Jirasek, L., Kalensky, J., John, J., Jirasek, A., and Pickova, J. Chronic intoxication by chlorinated hydrocarbons produced during the manufacture of sodium 2,4,5-trichlorophenoxy acetate. Prac. Lek. 26:332-339. 1974 27. Pazderova-Vejlupkova, J., Lukas, E., Nemcova, M., Pickova, J. and Jirasek, L. Chronic poisoning by 2,3,7,8-tetrachlorodibenzo-p-dioxin. Pracov. Lek. 32:204-209. 1980 28. Centen, A. H. J., Strik, J. J. T. W. A., and Colombi, A. Coproporphyrinuria and chronic hepatic porphyria type A found in people from Seveso.(Italy) exposed to 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD). pp. 75-81 in "Chemical Porphyria in Man" by J. J. T. W. A. Strik and J. H. Koeman. Elsevier/North-Holland, Amsterdam. 1979 �29. StrikT J. J. T. W. A., Jansen, M. M. T., and Colombir A. The incidence of chronic hepatic porphyria in an Italian family. Intern. J. Biochem. 12:879-881 1980 30. Topi, G. C. and Gandolfo, L. D'A. Clinical observationf diagnostics/ and therapy for symptomatic and hereditary porphyria cutanea tarda, pp. 107-110 in "Diagnosis and Therapy of Porphyrias and Lead Intoxication" by M. Doss'. Springer-Verlag, Berlin. 1978 �Office of the Administrator of Veterans Affairs Washington DC ^420 Veterans Administration Editor The Wall Street Journal 22 Cortlandt street New York, NY 10007 Dear Sir: The regrettable article on Agent Orange by Joan Maiman in the Wall Street Journal of April 13 repeats a persistent misunderstanding of the different cases represented by Times Beach and the Vietnam veterans. The differences, if not understood, lead to what appears to be a logical question as to why the government compensates one group of citizens and not another. The differences are real and the question can be answered by setting the record straight. The situations in Vietnam and in Times Beach are dissimilar in virtually every respect, notwithstanding that dioxin was involved in both instances, en the average, dioxin was present in concentrations of 2 parts per million in Agent Orange. For the most part it was sprayed from aircraft onto dense jungle vegetation where much of the dioxin was rapidly degraded by sunlight. In Times Beach a mixture of waste oils containing approximately 350 parts per million was applied directly to the ground resulting in soil concentrations of dioxin in the range of 300 parts per billion. In Vietnam, the average concentration of dioxin in the soil would not have exceeded 0.016 parts per billion, even if Agent Orange were applied directly on the ground and no degrading of the dioxin by sunlight occurred. The government acted in Times Beach to remove a continuing potential hazard by buying contaminated property. No person in Times Beach has been compensated for adverse health effects due to dioxin. Exposure of Americans in Vietnam ended ten years ago, and veterans have not been exposed to Agent Orange since then. The Vietnam veterans are asking for compensation for what they believe to be adverse health effects due to their prior Agent Orange exposure. Some 2,500,000 American military personnel served in Vietnam. It can be anticipated that among such a large group of veterans some will develop serious illnesses, suffer other adversities, and even father children with birth defects, a situation which tragically occurs in about 4 percent of all live births in the United States and most countries around the world. There is as yet, however, no scientific evidence that any single disease or characteristic group of illnesses have appeared as a result of service in Vietnam. �2. From the very beginning of the Agent Orange issue the Veterans Administration has maintained an open mind on the subject of potential health hazards resulting from exposure to herbicides in Vietnam. Vfe have worked very closely with other federal agencies, veterans service organizations, the U.S. Obngress and state organizations to address the many questions of concern to Vietnam veterans. A tremendous amount of research, both in this country and abroad, is being conducted to attempt to answer the many puzzling questions surrounding the whole dioxin dilemma. Much of this research is being funded by the Veterans Administration. In the meantime, the VA continues to provide health care to a large number of Vietnam veterans who believe they have health problems resulting from herbicide exposure, notwithstanding the lack of scientific evidence to support a cause-and-effect relationship. In addition, we have always encouraged any veterans who feel that they have been treated in a discourteous or unsatisfactory manner to call this to our attention. Such reports are investigated and corrective action is taken when justified. The General Accounting Office report on the Agent Orange program had, we believe, a number of flaws. Corrective measures were taken where the criticisms were justified. This is the appropriate response to such reviews. I want to stress that we remain sympathetic to Agent Orange claimants in the Vietnam veteran population. Vfe have repeatedly encouraged them to seek care in the Veterans Administration health care system when they require it, without prejudice to their claims. Vfe continue to carry out and support research and studies into the possible health effects of exposure to Agent Orange. Vfe do not yet have all the answers. Nobody does. The Veterans Administration will continue to remain true to its commitment of service to all veterans and to the American public. Sincerely, HARRY N. WALTERS Administrator �veterans Administration March 11, 1983 Department of Medicine and Surgery Washington D.C. 20420 Comparison of Missouri and Vietnam TCDD Episodes Recent newspaper and magazines articles on the dioxin contamination in Times Beach, Missouri, have prompted statements comparing that dioxin (TCDD) episode with the dioxin levels in Vietnam that may have resulted from the sparying of Agent Orange. Such a comparison is possible but only if similar components are compared. For example, road surfaces in Times Beach, were sprayed with waste oil that had been contaminated with 350 parts-per-million (ppm) TCDD. Agent Orange contaminated with 2 ppm TCDD was sprayed in Vietnam on jungle vegetation "primarily'' By""ffxed-^ing "aircraft* fl*yihgr*aC<!ah''' altitrOde'''of 150""'feet; above" the" * ' "-***»**'* " ground. Thus, although the dioxin compound is the same between the two episodes, the way it was introduced into the environment was very different. Personnel within the Department of Medicine and Surgery, who are experts on dioxins in the environment, are preparing an in-depth report on the differences between the two episodes. However, they have noted that the concentrations of TCDD in soil between the two episodes would be very different. The 300 parts-per-billion (ppb) level for TCDD found in Times Beach, Missouri would be over 20,000 times greater than the amount resulting from the spraying of Agent Orange directly to the bare soil (a level of 0.016 ppb, calculated). An adequate comparison would also have to include consideration for routes of exposure, length of exposure, and the environmental fate of TCDD. If these factors are all considered, it is apparent that the two situations are not analogues, and any comparisons of the potential for human risks must recognize these differences. �QUESTIONS t ,.,1. In a recent article in the Washington Post, VA Administrator Harold Walters ft was quote^ as stating that Vietnam veterans will riot have to wait for scientists ' to prove It direct link between the herbicide Agent Orange and certain kinds of ailments to qualify for disability benefits. The Administrator went on to say that if the government's epidemiological study shows that Vietnam veterans, as a group, are suffering a "statistically significant" rate of health problems that is higher than the. rate for non-veterans, the VA will consider those ailments service-connected. Therefore, it is my understanding from these statements that if the epidemiological study comes out positive for certain diseases that it could serve as a basis for compensation. I would like to know specifically if the CDC epidemiological study is going to serve as basis for policy for VA compensation for Agent Orange? /*2. What is the anticipated cast of the epidemiological study and is the VA going to reautllori^o funding for this study every year? 3. It is general principle in the field of epidemiological studies that rarer conditions can only be determined in large populations. Is the sample size of the CDC epidemiological study large enough to pick up rare conditions? 4. The VA has been monitorirjg medical treatment being given to veterans claiming ailments related to Agent Orange as directed under P. L. 97-72. In your views are veterans receiving the leveJ of attention laid out in the law? 5. The GAO in its October 1982 report on the Agent Orange Examining Program, criticized the VA's Agent Orange Registry for a number of inadequacies and recommended that the registry be discontinued. What is the status of the registry today? 6. I would like to know how applicable the findings of the Ranch Hand study are to Agent Orange victims as a whole? I believe the Ranch Hand participants had showers following their exposure to Agent Orange, whereas ground troops were unaware of their -exposure while it was sprayed from plane above them. In addition it is my understanding that the participants in the Ranch Hand Study have been found to be healthier than the general population. Would this factor influence (the results of this study? 7. As you know, there is a Swedish study which links soft tissue sarcoma to exposure to phenoxy herbicides. It is my understanding that the VA contends that the results of the Swedish study are not enough to show a connection. What I would like to know is if this study is not enough, does it mean our epidemiological study is not going to be enough to determine a connection between Agent Orange and certain diseases? •. s 8. How much scientific evidence is necessary to make veterans eligible for Agent Orange compensation? �9. We are all aware of the recent aw.'ird to the citizens of Times Beach, Missouri, for their exposure to dioxin. 1 would like to know the difference between exposure to dioxj.n in TiniesBeach_ anJ the exposure__tq dioxin of our troops in ___„ Southeast Asia?/ HoTPcan' w<T cotnpensaie~Tn one. case and not in the bther?^)^/^ • , fc 10. Has She VA or Department of Defense have any way of determining what areas in Southeast Asia were sprayed with phenoxy herbicides and what troops were directly sprayed with it? Have they any numbers on how many American civilians working in Southeast Asia and the U.S. during the Vietnam era were exposed to these herbicides? �BRIEFING OVERVIEW COMPARISON OF MISSOURI AND VIETNAM ^DIOXIN EPISODES » MARCH 1983 o Dioxirt (TCDD) as a Contaminant Sources and Toxicity Exposure versus Dose o o WAR 1 7 1383 UV1N L. YOUNG, Major, USAF Consultant, Environn-.2ntci Scier.;.=. Missouri versus Vietnam Issues for Resolution �A dioxin is any of a family of compounds known chemically as dibenzo-para-dioxins There are 75 different chlorinated dioxins There are 22 different tetra isomers 1 Dioxin oft Concern = 2,3,7,8-TCDD Cl C\ J -Cl •Cl �TOX1CITY OF 2,3,7,8-TCDD Single Dose LD^p pig/kg) Acute Toxicity: 0.6 40 Guinea Pig Rat Rabbit Monkey Dog Mouse Hanster Bullfrog Man Over 1000 No deaths reported in literature Teratogenic (Birth Defeats) Mouse Other species Cleft palate, kidney abnormality Embryo-and Fetotoxic Mutagenic (Mutation) Probably not a mutagen in higher animals Carcinogenic (Cancer) Liver, lung and oropharynx cancer noted in rats Significance: 115 70 150 200 3500 Bioavaiiability on Environmental matrices �EXPOSURE VERSUS DOSE Exposure Dose (Amount of TCDD in Environmental Components) (Amounts of TCDD in Biological Systems) Parts-per-billior Milligrams per kilogram body weight Part-per-trillioi Hicrograra per kilogram body weight �SOURCES OF HUMAN EXPOSURE o Industrial Accidents (Trichlorophenol Production) o Occupational Exposure (NIOSH Dioxin Registry) £ o Contaminated Industrial Wastes (Missouri Episode) j Herbicide Applications (Vietnam Episode) I Transportation Accidents o o *- 3 o Food - Contaminated Fish (Great Lakes) o Low Temperature Combustion o Hexachlorophene Exposures •£ Significance: VA Adipose Study �TCDD EPISODE COMPARISON Vietnam Times Beach Missouri Source of Contamination Agent Orange Waste Oil and TCP Residue Total Quantity of Liquid Dissemination 10.6 million Mean TCDD Concentration of Liquid 2 "ppra 356 ppm Estimated Total Quantity of TCDD 368 pounds 70 pounds Estimated Number of Acres Treated 3,000,000 'acres 5,000 acres gallons 18,000 gallons �TCDD EPISODE COMPARISON Continued Vietnam Times Beach Missouri Pounds TCDD/Acre 0.00013 Ib/A (0.06 gms ), 0.014 (6.4 gms) Method Introduced Into the Environment Aerial Spray onto Vegetation'4 I High Ground spray onto soil Very Low Soil TCDD Levels 0.016 ppb<* 300 ppb Water Levels Parts-jper-trillion on soil particles Parts—per-trillion on soil particles Likelihood of Photodegradation * Assume 3 gal inch of -soil. Agent Orange containing 2 ppm TCDD applied directly to top 1 �TCDD EPISODE COMPARISON Vietnam Veterans Times Beach Missouri Residents Personnel Likely Exposed Men (Women) Men, women, children Potential Dates of Exposure 1965-1971 1971-1983 Length of Exposure 1 Day - 1 Year 1-11 Years Major Routes of Contamination Dermal Contact with Liquid (Probably Rare) Environmental: Soil Water Dermal Contact with Liquid (Rare); Environmental: Soil, Water Health Status Agent Orange Registry Exam (Chloracne under review) Chloracne reported in 5 people in 1971; Current health apparently normal �ISSUES FOR RESOLUTION Agencies primarily FDA EPA VA concerned with TCDD CDC OSHA DOT USDA USDI DOD Issues o o o o Clarification of Compensatory Policies and Responsibilities Level of contamination permitted in Herbicides Level of contamination permitted in food and water Hazardous waste management criteria Needs o o o Interagency Dioxin Workgroup-science coordination Risk assessments and agreements on no-effect-levels Determination of bioavailability in environmental substrates �Q. T: understand that Gong. Daschle has recently introduced legislation to provide presumptive service-connection for soft-tissue sarcoma, porphyria cutanea tarda, chloracne and chloracneform lesions. Wiat is the VA's position on this proposal? A. The VA has given careful consideration to Congressman Daschle's Bill (HR 1961) and we -find it difficult to determine precisely how to implement the provision for compensating the specified conditions. Soft-tissue sarcomas are a varied group of cancers that are not always clearly defined. Some authorities include among soft-tissue sarcomas tumors that others do not. Porphyria cutanea tarda is a single disease, so far as we know, but the disabling phase of the condition follows promptly after exposure to a triggering chemical, the Bill assumes that this exposure occurred in Vietnam ten or more years ago. Alcoholism, however, triggers attacks and eventually the cumulative damage from alcohol can produce more persistent defects. It will not be clear whether the VA is granting continuing compensation for porphyria cutanea tarda in the past or for alcoholism in the present. �"Chloracneform" is a new term, not found in medical language. By analogy it means "resembling chloracne", we believe. If this is true, " chloracneform lesions" include acne vulgaris, the common acne that is experienced by most of us as adolescents and sometimes persists into our adult years. It is unlikely that common acne is caused by military service although it may be made temporarily worse by service in tropical climates. �0. What is the VA's reaction to the recently released report of the Australian Birth Defects Study? A. The Australian Veterans Health Studies have issued their report entitled "Case-Control study of Congenital Anomalies and Vietnam Service (Birth Defects Study)." The investigators determined whether the fathers of 8r517 defective children and an equal number of normal children were military veterans and whether they had served in Vietnam. The fathers of 329 defective children had served in the armed forces and 127 had been in Vietnam. The fathers of 329 normal children also had been in the armed forces and 123 were Vietnam veterans. There was no evidence that Vietnam service increased the risk of fathering a defective child nor that military service influenced the ,risk. Length of service in Vietnam was also without effect on the chance of having a malformed child. The investigators could not establish with statistical certainty that any one defect or group of defects was more common in the children of Vietnam veterans. The Australian study has thus given results similar to those with other exposed groups of men chemical workers and pesticide sprayers. It supports the belief that there is no increase in birth defects as the result of Vietnam service and the exposure to Agent Orange of veterans. �0. Aren't there scientific studies showing that Agent Orange or the chemicals in it cause soft-tissue sarcomas and prophyria cutanea tarda as well as chloracne? A. Chloracne has certainly been shown to be caused by dioxin, a chemical contaminant in Agent Orange. The active condition, however, usually persists for less than two years unless there is continuing contact with some chemical that causes it. In two industrial situations, porphyria cutanea tarda appeared in some individuals who had intense exposure to dioxin, a contaminant of Agent Orange. As usually true for porphyria cutanea, the changes disappeared within five years. The reports saying that the observed liver changes persisted for years do not state whether these individuals are alcoholics nor were they tested for abnormal liver functions before their exposure to the chemical. In our opinion, the evidence for continued porphyria due to exposure to the ingredients of Agent Orange is not scientifically acceptable. Soft-tissue sarcomas were associated, as you know, with phenoxy herbicides by a single group of Swedish investigators who performed two case-control studies among agricultural and forestry workers. Related studies in Finland and New Zealand did not find any associations. Less scientifically controlled studies have supported the Swedes and other similar studies have not shown any association of soft-tissue sarcomas with • herbicides. 4 �The pros and cons of these studies are complex, opinions among -experts are not firmly held, and it seems wise to interpret them cautiously. The Advisory panel on ibxic Substances of the American Medical Association has said of the ingredients of Agent Ctange "while 2,4,5-T and 2,4-D pesticides have been used in agriculture, forest management and residential landscaping for over 30 years, there is still no conclusive evidence that they and/or TCDD (also called dioxin) are metugenic, carcinogenic or teratogenic in man, nor that they have caused reproductive difficulties in the human", In brief, it cannot be said that there is conclusive evidence that exposure to Agent Orange causes soft-tissue sarcoma. �Q. Wiat is the purpose of the Vietnam Service Indicator? A. The Vietnam Service Indicator is used to identify a veteran who actually had in-country Vietnam service. This indicator is now placed on the veteran's patient data card which is used to imprint the forms entered into the medical record. This indicator enables the medical center personnel to identify any tissue specimen of a Vietnam veteran which should be forwarded for inclusion in the AFIP Agent Orange tissue registry. More importantly, the indicator is entered into the PTF System and will enable us to report on the number of hospitalizations for Vietnam veterans and allow us to obtain specific diagnostic information. The Vietnam Service Indicator will also allow us to monitor the unpact of P.L. 97-72 as it relates to outpatient visits. The Vietnam Service Indicator was implemented on July 1, 1982 for all hospital discharges entered in the P1F. The veteran's patient data cards will be updated as the veteran comes to the medical center for treatment. The indicator will be placed in the PTF system when the earlier records have been reviewed under the contract with JAYCCR. �0. Based on the findings in the GAO report, there are considerable deficiencies documented for the Agent Orange Registry. What does the agency plan to do regarding the GAO findings? A. The GAO report utilized several findings that were outdated; these findings were based on a review of activities which occured in 1980. Significant improvements were made in the interim but were not reflected in the GAO report. GAO was asked to reconsider several criticisms by utilizing the current information and declined the opportunity. The VA has carefully reviewed the recommendations made throughout the report and continues to act forthrightly to implement those with merit and will continue to make improvements in the existing system. �0. According to the GAO report, 57 percent of the veterans surveyed indicated dissatisfaction with the completeness and thoroughness of the Agent Orange physical examination. How does the agency plan to correct this deficiency and assure that veterans are receiving complete thorough physical examinations? A. It is extremely difficult for non-health professionals to evaluate the performance of health professionals. Much of what is done during a physical examination is inapparent to the person being examined. A related limitation occurs when a person evaluates the physical examination that occurred months earlier. Many persons will be unable to recall whether specific questions were asked or how complete an examination of body systems was conducted. Cn many occasions through conference calls, CMD Information letters and circulars, the VA stressed to the physicians the need to assure that a complete physical examination be performed and well documented. This will continue to be our policy. The report of veterans of unsatisfactory physician performance is more valuable as an indicator of the veteran's satisfaction in general than of the quality of the examination. The GAO report indicates some appreciation of this fact and the GAO team examined medical records to evaluate the professional performance of the examiners. The record audits were taken to determine the quality of the examination. Ihese can be important but records are difficult to evaluate as reflecting the quality of professional performance and probably cannot be accomplished by persons who are not qualified health care professionals. �Q. The GAO report recommended that if the Agent Orange Registry was discontinued, a substantial cost could be eliminated or transferred to a program to benefit veterans. But, in the November 30, 1982 Advisory Committee on the Health-Related Effects of Herbicides meeting, it was stated that the costs of Che registry may be reduced by planned refinements in the existing system. How can the agency justify the expansion of the Registry when GAO has recommended it be discontinued. A. The Agent Orange Registry is the only way the VA has to identify any Vietnam veteran who is concerned about the possible adverse health effects due to the exposure to Agent Orange. Vfe are monitoring the Registry to determine what refinements can be made to better utilize the information. In August 1982, we issued EM&S Circular 10-82-154 entitled, " Agent Orange Registry Follow-up Activities." This circular established procedures for obtaining the current address of every veteran who had received an Agent Orange examination and conducted a small health questionnaire of the registry participants. The veteran's current address will be entered into the computerized registry to establish a mailing list for maintaining future contacts. In December 1982, OMB granted approval for the revision of the Agent Orange Registry code sheet, the revised registry code sheet will obtain the veteran's address, sex, specific diagnosis for the veteran's health problems and other related information. This information was not obtained in a computerizable form previously and there is a demonstrable need to have this information readily available. The new registry code sheet which facilitates the information gathering/coding process in i the medical centers, was implemented in March 1983. �0. When does the VA plan to establish a statutory framework for determining how much and precisely what kind of evidence it will take to compensate Vietnam veterans and their families for the various illnesses and disabilities attributed to Agent Orange exposure? If the VA does plan to develop such a framework, will it be completed before the Air Force and Center for Disease Control report on the initial findings of their respective studies? A. The VA already has ample statutory authority to compensate veterans or their survivors for disabilities or death due to injuries and diseases incurred or aggravated in service. 38 U.S.C. Sections 310 et seq., 410 et seq. A new statutory framework is not required. What is lacking is a scientific basis upon which it can be reasonably concluded that long-term adverse health effects (other than chloracne) have resulted from exposure to herbicides in Vietnam. It is deeply hoped that the Air Force and CDC studies will further this scientific inquiry. 10 �Q. A. After stating for years that animal studies could not be used to correlate dioxin's effects on humans, the VA has recently awarded $4.7 million for Agent Orange research exclusive of the epidemiology study. Does this mean that the VA will accept animal studies as .evidence for paying compensation? Various animal species react differently to the same substance. Dioxin or TCDD given by mouth to guinea pigs is at least 500 times as lethal as it is for dogs when the amount given is corrected for the differences in the animals' weights. Cats are stimulated by morphine; dogs are depressed. Such differences make it difficult, if not impossible, to accept the results obtained in one or several species when given dioxin as firm indicators of what dioxin does to humans. Animals are used to investigate the effects of dioxin, as the most toxic component of Agent Orange, because it is impossible to perform many fundamental experiments on humans. This is particularly true of research that involves exposing the living experimental subject to such a toxic material as dioxin. There is no satisfactory way to determine, for example, how the body can rid itself of the toxic material except to examine this phenomenon in several species. The results obtained from this research are then compared with what is known to occur in man. 11 �A. (continued) The VA is seeking sources of information about Agent Orange and dioxin that will help detect and treat possible ill effects from contact with them. Any information clarifying the effects of exposure to these chemicals will be used to decide whether to compensate veterans. Because of the differences between various animal species and man, however, the VA does not accept the results of animal studies unsupported by results from studies of humans as satisfactory evidence for paying compensation to veterans claiming exposure to Agent Orange. 12 �Q. Now that the epidemiological study has been transferred to CDC, what is the VA's role in this study? Has the protocol been finalized? Is CDC using all or part of draft protocol designed by UCLA? When will this study actual start and be completed? A. Under the terms of the interagency agreement, approved January 14, 1983, the VA has very limited responsibilities. Vfe have provided CDC with the preliminary study designed developed by UCLA, along with extensive review comments and other pertinent documents. The VA will not be involved in the actual conduct of this study in any way. Vfe have not yet seen the protocol which the CDC will use for the conduct of the study. The interagency agreement provides that the CDC will complete the epidemiclogical study as expeditiously as possible, but not later than September 30, 1987. 13 �Q. There is a perception that the VA is not doing a very good job handling veterans concerned about Agent Orange. Many people believe that the VA unnecessarily delayed the epidemiological s£udy (in three years the agency could not even develop a final protocol), is doing a poor job in the examination/registry program (see the GAO report), and is refusing to compensate sick and dying veterans. Is this perception accurate? If not, what is the VA doing to correct this misperception? A. We feel that this perception is not accurate and will change when veterans learn what the VA has done and is doing to serve them. The epidemiology study, unfortunately, was delayed by factors totally beyond our control. Ihe GAO report was outdated long before its publication and represented problems inherent in any massive nationwide program in its initial stages. Ihe VA does compensate veterans with injuries and illnesses which were incurred in or aggravated by military service. Ihe Office of Public and Consumer Affairs has developed an extensive program to advise Vietnam veterans about our program. 14 �Q. Public Law 96-151, approved in December 1979, required the VA to conduct an epidemiological study of Vietnam veterans exposed to Agent Orange. It was not until February 1983 - one month after the transfer of this study that the VA actually hired an epidemiologist for the Agent Orange program, What does this indicate about the commitment of the agency to the resolution of the Agent Orange controversy? What will the epidemiologist be doing now that the study has been transferred? A. The VA has long planned to hire an epidemiologist to conduct or monitor the study mandated by P.L. 96-151. This expertise/ however, was not required during the early planning stages of this study. We are very pleased that Dr. Han K. Kang, a well qualified epidemiologist, formerly employed as a senior epidemiologist, Occupational Health and Safety Administration (OSHA), has now joined our staff as Chief, Research Section, Agent Orange Projects Office. Dr. Kang will supervise a wide range of vital research activities relative to the Agent Orange controversy. 15 �0. According to GAO, you could save almost $1 million a year in administrative staff and computer costs by discontinuing the computerized Agent Orange Registry. How much does your budget request include for the registry? A. The VA does not know how GAO arrived at the costs of $1 million a year for the Agent Orange Registry. The registry activities are not cost accounted but are rather insignificant inclusions in other budget items, e.g. patient care. Because of this, we cannot give specific costs associated with the registry. Costs of operating the registry, in a large part, are being absorbed through existing resources at the national and local level. The VA does have a specific line item in FY 1984 of $45 thousand identified for the registry. As I said, other activities of the registry are covered by other components of the VA but the budget does not identify the portion ascribable to the registry. 16 J3-/C, �0. What are the VA's plans concerning the expansion of Agent Orange Registry Activities? A. The conputerized record of Agent Orange Registry has been revised. The Office of Managment and Budget (CMB) granted approval for the revision of the Agent Orange Registry code sheet which is utilized by all VA health care facilities to record information obtained through the interview and examination process. As soon as it is printed, the revised Agent Grange Registry code sheet will be used to obtain veteran's name, address, specific diagnosis for the veteran's health problems and other related information. Not all of this information was obtained in a computerizable form previously and there is a demonstrable need to have the data readily available. The Agent Orange Registry address information will be used by the VA's Agent Orange Projects Office to assist in the conduct of periodic health surveys of registry participants. The computerized mailing list will also be used by other VA offices to provide registry participants with updated information on VA policy, health care programs, research, and other significant Agent Orange-related information. 17 �Q. Couldn't money spent on the computerized Agent Orange Registry be better used to insure the quality and thoroughness of examinations? A. No. The computerized registry is the only way the VA has to identify and uniformly record information on Vietnam veterans concerned about the adverse health effects from possible exposure to Agent Orange. The environmental physicians have been asked to ensure that each veteran who applies receives a complete and thorough physical examination. 18 �Q. Have any funds been included in VA budget requests to cover the costs of analyzing and releasing Agent Orange Registry data on the types of health problems experienced by Vietnam veterans? It not why? A. No, but any expense of examining the registry's contents will not be great. The Agent Orange Registry is not designed as a statistical tool to determine the occurrence rate of health problems experienced by Vietnam veterans. Data based on a self-selected population, such as the registry, is misleading and often is misconstrued by people not versed in medical statistics. Health data obtained from such a self-selected population is neither valid nor reliable as an indicator of how often a disease or disability occurs since it almost always over-estimates its frequency. Ihe release of data derived from the registry thus can be alarming to Vietnam veterans without serving a useful purpose. Qi the other hand, the registry is very useful to identify, examine and establish permanent health care records on concerned Vietnam veterans reporting to our health care facilities. Accordingly, the VA is now in the process of enhancing the possible beneficial aspects of the registry data base. 19 �Q. What will be done to eliminate the errors in the 89rOOO locator cards already in the registry? A. The Agent Crange Registry contains demographic, historical and medical information on all Vietnam veterans participating in the program. The locator cards are maintained by each VA health care facility to identify the Vietnam veterans who have participated in the Agent Crange Registry. The locator card contains the veteran's name, address, social security number, date of birth and dates of examinations (initial and follow-up). Instructions for, the preparation and maintenance of the locator cards have been issued through agency circulars. Recently, all Agent Orange Registry participants were mailed a name and address questionnaire for the purpose of obtaining and recording the veteran's current address so that our address files could be updated. 20 �0. VA recently signed an agreement with CDC for transfer of the Agent Orange epidemiology study to CDC. Ihe agreement calls for transfer of 28 FTEE and $3 million from VA to CDC during FY 83. Are there funds included in the FY 84 VA budget for the CDC study? A. The interagency agreement between the VA and CDC, which was signed on January 14, 1983, provides that the VA will submit the CMB and the appropriate committees of Congress specific requests frcm the CDC for fiscal and personnel resources to support the conduct pf the study. There is currently available $3 million for CDC to initiate the conduct of the pilot phase of the epidemiological study in FY 83. The availability of these resources will terminate on September 30, 1983. the interagency agreement provides for the VA to assist in obtaining CMB approval of CDC's request for 28 full-time equivalent employees (FIEE). The CMB has approved the requested positions. CDC has provided the VA with justifications for FY 84 resource support of the study and these have been sent to the CMB as resources required during FY 84. They provide the basis for a FY 84 supplemental request. 21 3- �Q. Has the Centers for Disease Control (CDC) recommended that the registry be maintained by the VA? A. CDC has made no reoonmendation for the continuance of discontinuance of the registry. Ihe Agent Orange Registry was developed by the VA to identify all Vietnam veterans who are concerned about the possible ill-effects from exposure to Agent Orange. The registry was never defined as, or intended to be, a statistical tool for a scientific, epidemiological study. 22 �0. Wiat costs will be incurred by the VA during FY 84 for Agent Orange? A. Current budget projections include an agency estimate of approximately $95 million associated with the conduct of activities related to Agent Orange. The projected costs are related to the continuance of the VA's Agent Orange Registry, the provision of medical care and treatment to eligible Vietnam veterans as authorized by Public Law 97-72; an update of the literature analysis of worldwide scientific literature originally mandated by Public Law 96-151; the conduct of Agent Orange-related research, including specially solicited research by VA research staff; the maintenance of the VA's Agent Orange Projects Office and information activities of the Office of Public and Consumer Affairs. The projected costs do not include those resources which will be required by CDC's conduct of the pilot phase of the epidemiology study. 23 �Q. Wiat Agent Orange activities will the additional 5 FTEE assigned to the Research Section of the Agent Orange Projects Office be performing in FY 1984 and beyond? A. The 5.0 F1EE assigned to the Research Section, Agent Orange Projects Office, will continue to carry out in BY 1984 those research activities begun in FY's 1982 and 1983. In addition to following the progress of CDC in conducting the epidemiology study mandated by Public Law 96-151, the 5.0 FTEE will be engaged in the continuing conduct or monitoring of a mortality study on Vietnam veterans. They will continue to oversee and later edit the four scientific monographs on environmental factors that may affect the health of military service personnel serving in Vietnam. Oversight and coordination of the conduct of a Vietnam Experience Twin Study of identical twin veterans, where one veteran served in Vietnam and one did not, will be another of the major responsibilities of this staff. Finally, the staff will be involved in monitoring a retrospective study of chlorinated dioxins and furans in adipose tissue. This latter study will be completed under an interagency agreement between the VA and the Environmental Protection Agency. Ihis study will assist in establishing background levels of 2,3,7,8-TCDD in the U.S. male population and in determining whether service in the military, and especially in Vietnam, has had an effect on the level of TCDD in adipose tissue. In addition to these currently ongoing efforts, it is anticipated that the 5.0 F1EE will be involved in 1 the conduct of other research efforts which may be subsequently identified. 24 �Q. When do you expect the Centers for Disease Control (CDC) to complete the epidemiology study? A. The CDC has told us that they expect to oorrplete the study in 1987. 25 �Q. Are you satisfied that the CDC's projected date for completion of the epidemiology study in 1987 is realistic? A. The VA would like to have the results of the epidemiological study as scon as possible but it seem to us that 1987 certainly does not represent an unrealistic period of time to allow a completion of the study. 26 �Q. In its report to the Congress concerning the VA's Agent Orange Examination Program, the Comptroller General, last October, noted that although the VA has prepared informational materials on Agent Orange, they were not generally available outside of VA medical facilities, regional offices or outreach centers. What specific efforts have you taken to inform people on this issue of public concern? A. It is readily evident that the Agent Orange issue centers around one of the most fundamental tenets of our political culture, namely, the care we owe to those disabled in the armed service of our country. The Veterans Administration, as the primary provider of this care, has developed an extensive network for the dissemination of information on all VA benefits and services. Over the last twenty years we have expanded and improved public accessibility to our regional office network by implementing a national system of toll-free telephone service so that anyone may speak with a veterans benefits counselor for no more than the cost of a local call. We have consciously publicized this system so as to make it the source of readily available VA information within the community. •27 �A. (continued) In light of our development of this system and efforts to channel inquiries into it, we believe that it is only a logical consequence that we have focused our resources and expertise to meet the demand here for information that the public requires. Our veterans benefits counselors have been kept abreast of Agent Orange developments as well as VA-related services and are in the best position in providing accurate information and assistance. The emotion surrounding much Agent Orange discussion seem, at times, to beg for impulsive reaction such as the unilaterial widespread or even blanket distribution of material on the subject throughout our area. The reality, however, of scientific research at this stage is far short of conclusive and such a distribution runs a serious risk of engendering an unnecessary alarmism. Our approach to dissemination of Agent Orange information has tried to balance the products of a rigorous scientific inquiry and the natural concerns of individuals possibly affected. 28 �A. (continued) Besides our own efforts in this area we have tried to assist/ as far as possible, state and local Agent Orange initiatives. When the California state legislature authorized an Agent Orange outreach effort last year, VA regional office personnel made presentations to their service officers to add to their general knowledge and familiarize them with our resources. Vfe have also worked with the New York State Temporary Cbttmission on Dixoins in making their literature available. In dealing with Agent Orange, neither a fortress mentality nor a panic reaction is in the best interest of the public we serve. We have and will continue to be true to our primary responsibility, a charge at the heart of our political culture, to care for those who have borne the battle. 29 �Background BIRTH DEFECTS: AUSTRALIAN INFORMATION SERVICE J *,;.•,•?•' '.'.•^•: ;v^-(-uv"!.•<-- ' -••• .. '-*.. • Embassy of Australia lfi()| MiissitriuistMis Avc,. NAV. AUSTRALIAN GOVERNMENT STATEMENT Funlier inluntwdon caJI: 797-3175 .. 797-3165 �BIRTH DEFECTS STUDY RESULTS RELEASED The first scientific study of the subject ever completed has found that Australian veterans of the Vietnam conflict were, not at increased risk of fathering a malformed child. The Minister for Veterans' Affairs, Senator Tony Messner, said that the report provided some of the best news which could be given to anxious veterans and their wives. The report, entitled "Case-Control Study of Congenital Anomalies and Vietnam Service (Birth Defects Study)", was released by the Minister today. The study was conducted by an expert team assembled by the Commonwealth Insitute of Health, University of Sydney. In the study, children born with any of a defined set of congenital anomalies were identified from hospital and cytogenetic laboratory records and their fathers were identified as belonging to one of three groups of Australians: Vietnam veterans; contemporary Army personnel who did not serve in Vietnam; or community members who did not serve in the Army at that time. The most basic finding of the study was that Vietnam service was shown to have had no effect on the risk of fathering a malformed child. The analysis also showed that: The risk of fathering a malformed child was no higher for either Vietnam veteran or Army non-Vietnam veteran fathers than for other Australian males. The risk was not different for National Service and Australian Regular Army Vietnam veterans. The investigating team's analysis demonstrated the high degree of confidence which could be placed in the results, Senator Messner said. The Minister pointed out that the separate and independent Scientific Advisory Committee, a group of eminent experts in the fields of medical science and statistics, had progressively assessed the methodology as the study proceeded. In endorsing the validity of the findings, the Committee advised that the report was a comprehensive, detailed and well written report of a well conducted study. Senator Messner paid tribute to the dedicated efforts made by the investigating team to complete this very detailed study. Scientific investigation where feasible was an important element of the government's overall program to bring out the facts on Vietnam service and to assist veterans. "I am delighted" the Minister said, "that an authoritative *"" t- �2. study is now available. The results should reassure those veterans and their wives who were anxious about having children that there is not a birth defects problem peculiar to those fathers who served in Vietnam". A summary of the study's findings as they appear in the report is provided in the attachment to this release. •3V-3 �SUMMARY - BIRTH DEFECTS STUDY THIS INVESTIGATION WAS ORIGINALLY DESIGNED AND COMMENCED BY DR ROBERT MACLENNAN, THEN ASSOCIATE PROFESSOR OF EPIDEMIOLOGY, COMMONWEALTH INSTITUTE OF HEALTH, UNIVERSITY OF SYDNEY, AND CONTINUED BY DR JOHN DONOVAN, THE SENIOR ADVISER IN EPIDEMIOLOGY TO THE DEPARTMENT OF HEALTH. DR DONOVAN LATER MODIFIED CERTAIN ASPECTS OF THE ORIGINAL DESIGN IN THE LIGHT OF THE FIELD EXPERIENCES OF HIS TEAM AND WAS RESPONSIBLE FOR CONDUCT OF THE STUDY AND PREPARATION OF THIS REPORT. THE INVESTIGATION INVOLVED EXAMINATION OF THE HOSPITAL AND CYTOGENETIC LABORATORY RECORDS OF INFANTS BORN WITH ANOMALIES (BIRTH DEFECTS) IN NEW SOUTH WALES, VICTORIA AND THE AUSTRALIAN CAPITAL TERRITORY BETWEEN THE YEARS 1966 AND 1979 INCLUSIVE. IN ALL, 34 HOSPITALS AND 4 CYTOGENETIC LABORATORIES WERE INVOLVED AND COOPERATED FULLY WITH THE INVESTIGATING TEAM. WHENEVER THE BIRTH OF AN INFANT WITH AN ANOMALY WAS DETECTED, IT WAS MATCHED TO A HEALTHY CONTROL INFANT BORN IN THE SAME HOSPITAL, TO A MOTHER OF SIMILAR AGE, AND AS CLOSE AS POSSIBLE IN TIME TO THE BIRTH OF THE CHILD WITH THE ANOMALY. THE FATHERS OF BOTH CASES AND CONTROLS WERE IDENTIFIED IN 8517 INSTANCES AND THOSE IDENTIFIED WERE COMPARED WITH A LIST OF EVERY MAN WHO SERVED IN THE AUSTRALIAN ARMY BETWEEN 1962 AND 1972, WHICH WAS THE PERIOD OF AUSTRALIAN INVOLVEMENT IN VIETNAM. FATHERS IDENTIFIED AS HAVING SERVED IN THE ARMY DURING THIS PERIOD WERE THEN CLASSIFIED ACCORDING TO WHETHER OR NOT THEY HAD SERVED IN VIETNAM. THE SAMPLE WAS LARGE ENOUGH TO ENABLE THE STUDY TO MEET ITS AIMS. (CHAPTER 1) THE IMPORTANT FINDING FROM THE STUDY IS THAT 127 OF THE FATHERS OF CHILDREN WITH ANOMALIES WERE VIETNAM VETERANS, WHILST 123 VETERANS WERE AMONGST THE FATHERS OF HEALTHY CHILDREN. THIS INDICATES THAT THERE IS NO EVIDENCE THAT ARMY SERVICE IN VIETNAM RELATES TO THE RISK OF FATHERING A CHILD WITH AN ANOMALY. (CHAPTER 2) THE FINDING GIVEN ABOVE NEEDS TO BE CONFIRMED BY STATISTICAL ANALYSES. THESE USE THE MOST APPROPRIATE AND UP-TO-DATE METHODS. (CHAPTER 3) THE FIRST STATISTICAL EXAMINATION CONFIRMS THAT THE MATCHING OF MALFORMED WITH HEALTHY INFANTS WAS GENERALLY ADEQUATE, BUT THAT A SMALL ADDITIONAL STATISTICAL ADJUSTMENT FOR AGE OF MOTHER MAY BE NECESSARY IN LATER ANALYSES. RISK WAS LEAST FOR MOTHERS AGED 25. (CHAPTER 4) OTHER FACTORS ON WHICH INFORMATION UAS AVAILABLE AND WHICH MIGHT BEAR ON RISK WERE THEN EXAMINED. THE RISK OF MALFORMATION IS HIGHER IN MALE CHILDREN THAN IN FEMALE, AND IN MULTIPLE THAN IN SINGLE BIRTHS. THE NATURE OF BOTH THESE RELATIONSHIPS ALSO VARIES WITH AGE OF THE MOTHER. STATISTICAL TECHNIQUES WERE USED TO ALLOW FOR THESE RELATIONSHIPS IN LATER ANALYSES OF RISK ASSOCIATED WITH VIETNAM SERVICE OF THE FATHER. ANOTHER FACTOR EXAMINED WHICH NEEDED "TO BE TAKEN INTO ACCOUNT IN THESE LATER ANALSYES WAS BORTHPLACE OF THE FATHER. FACTORS EXAMINED WHICH PROVED NOT TO NEED TO BE TAKEN INTO ACCOUNT "INCLUDED AGE"OF THE FATHER, SOCIO-ECONOMIC GROUP OF THE �2. FATHER, BIRTHPLACE OF THE MOTHER, AND URBAN OR RURAL RESIDENCE OF THE PARENTS. (CHAPTER 5) THE STUDY GIVES PERSUASIVE EVIDENCE THAT VIETNAM SERVICE HAS NOT BEEN ASSOCIATED WITH ANY IMPORTANT INCREASE IN THE RISK OF BIRTH DEFECTS IN CHILDREN OF VETERANS. ACCORDING TO THE STANDARD STATISTICAL ESTIMATION PROCEDURE, THERE IS A 95 PERCENT CHANCE THAT THE TRUE VALUE OF THE RISK OF A VIETNAM VETERAN FATHERING A MALFORMED CHILD COMPARED WITH THAT OF A NON-VETERAN LIES BETWEEN 0.78 (A 22 PERCENT DECREASE) AND 1.32 (A 33 PERCENT INCREASE). THE MOST LIKELY ESTIMATE OF THE RISK IS t.02, ONLY 2 PERCENT GREATER THAN NO DIFFERENCE AT ALL IN RISK. WHEN THE RISKS WERE ESTIMATED SEPARATELY FOR AUSTRALIAN REGULAR ARMY AND FOR NATIONAL SERVICE VETERANS THEY WERE FOUND TO BE SIMILAR. THE SAME APPLIED FOR COMPARISONS OF RISK IN CONTEMPORARY MEMBERS OF THE AUSTRALIAN REGULAR ARMY AND NATIONAL SERVICEMEN WHO DID NOT SERVE IN VIETNAM, COMPARED WITH AUSTRALIAN FATHERS WHO DID NOT SERVE IN THE ARMY. COMPARISONS OF RISKS WERE ALSO MADE WITH OTHER ASPECTS OF VIETNAM SERVICE WHICH MIGHT HAVE BEEN EXPECTED TO BEAR ON AN INCREASE IN RISK, HAD ONE BEEN FOUND. WHILE THERE WAS A TENDENCY TOWARD LOWER RISK FOR VETERANS WITH LONGER VIETNAM SERVICE, NO EFFECT ON RISK OF THIS, OF TIME BETWEEN DEPLANEMENT AND CONCEPTION, OR CALENDAR YEAR OF VIETNAM SERVICE, WAS DEMONSTRATED. WHEN VETERANS WERE SUB-DIVIDED ACCORDING TO WHETHER THEY HAD SERVED IN VIETNAM BEFORE CONCEPTION OF THE CHILD, OR ONLY AFTERWARDS, IT' WAS FOUND THAT THE RISKS WERE SIMILAR, WITH ESTIMATES SLIGHTLY HIGHER FOR CHILDREN CONCEIVED BEFORE THE FATHER HAD BEEN TO VIETNAM. EXAMINATION OF THE STUDY PROCEDURES REVEALED SOME LIMITATIONS IN DATA SOURCES AND IN HANDLING. THE ANALYSES WERE REPEATED IN WAYS WHICH DEMONSTRATED THAT THESE COULD NOT HAVE INFLUENCED THE CONCLUSIONS. IT WAS ALSO SHOWN THAT THE WAY IN WHICH THE STATISTICAL ADJUSTMENTS FOR VARIABLES ASSOCIATED WITH RISK WERE MADE DID NOT AFFECT THE CONCLUSIONS. TO THE EXTENT THAT WAS POSSIBLE IN A STUDY OF THIS SIZE, THE DATA WERE EXAMINED TO SEE WHETHER THERE WAS ANY SINGLE MALFORMATION OR GROUP OF MALFORMATIONS SUFFICIENTLY STRONGLY ASSOCIATED WITH VIETNAM SERVICE TO JUSTIFY FURTHER EXAMINATION. NO FURTHER EXAMINATION WAS WARRANTED. (CHAPTER 6) THE LIMITATIONS OF THE DATA SOURCES AND THEIR HANDLING WERE FURTHER EVALUATED. THIS EVALUATION INCLUDED THE REWORKING OF 1HE PROCESSING FOR A 2 PERCENT SAMPLE OF THE DATA. IT WAS CONCLUDED THAT THERE SHOULD BE CONSIDERABLE CONFIDENCE IN THE VALIDITY OF THE FINDINGS. (CHAPTER 7) THERE IS NO EVIDENCE THAT ARMY SERVICE IN VIETNAM HAS INCREASED THE RISK OF THE BIRTH OF A CHILD WITH AN ANOMALY. �Background EXTRACT FROM AUSTRALIAN PARLIAMENTARY REPORT On 15 October 1981, the Senate resolved that the following matter be referred to the Standing Committee on Science and the Environment: The use of pesticides, particularly phenoxy chemicals and chemicals containing dioxin with reference to: (a) their ecological effects; and (b) their effects on human and animal health; and that in considering this matter the Committee deal first with the possible effects on Vietnam veterans of exposure to herbicides. The Committee agreed that the Inquiry should best proceed in two stages: The first pertaining to the possible effects on Vietnam veterans of exposure to herbicides; and the second to the use of pesticides in Australia with reference to their ecological and health effects. This First Report, therefore, relates to the first stage of the Inquiry. However, the Committee recognises that many of the issues examined in this First Report, e.g. those relating to exposure to potentially harmful chemicals and the mechanisms by which birth defects are caused, are extremely complex. The Committee regards the response of the Government to this Report as both urgent and crucial. In view of all the circumstances, the Committee expects the Government's response by 31 March 1983. The Committee will meet again to consider the Government's response and any further information arising from current research and make a further report to the Senate. The Committee conducted ten public hearings between 8 December 1981 and 22 September 1982 at which 39 witnesses gave evidence. The hearings took place in Canberra (4), Melbourne (2) and Sydney (4). AUSTRALIAN INFORMATION SERVICE Embassy of Australia 1601 Massachuseits Avt>.. N.W. \VashinKioii. D.C. '_><)<W>-'_>'.>7:< Futther information call: 797-3175 797-3165 797-3373 �RECOMMENDATIONS The Committee is unanimous in recommending: (1) That the measures handling enforced Department of Defence impose more stringent to ensure that the instructions for the and spraying of pesticides are rigidly (p. 57); (2) that much more attention be paid by the Australian scientific and medical communities to promoting an understanding of the heritable genetic effects that may result from the exposure of humane to mutagenic chemicals (p. 76); (3) that the Commonwealth Department of Health, in collaboration with appropriate medical and scientific bodies, undertake a public education program on the nature and origin of birth defects and the frequency of their occurrence in the community (p. 95)t (4) that the CIH, with the co-operation of the WAA, establish a mutually acceptable panel of psychiatrists and neurologists to examine Vietnam veterans who claim to be afflicted by chemically-caused psychiatric conditions in order to provide an independent assessment of the symptom profile commonly reported amongst Vietnam veterans (p. 147); (5) that in view of the time taken over the morbidity study, a decision be made to proceed with due emphasis being placed on attempting to establish whether psychiatric symptoms in Vietnam veterans are due to a war neurosis or exposure to harmful chemicals (p. 160); (6) that priority be given to the conduct of the retrospective mortality study because of the likelihood of it producing an answer to the question of whether the rate of deaths among veterans is excessive (P. 160); (7) that the case-control possible (p. 160); study be completed as soon as (8) that the review of the repatriation legislation include an examination of the way in which the determining authorities have been applying the evidentiary provisions of the legislation. The review should also examine whether the determining authorities have been relying too heavily on information provided by departmental sources (p. 170); . . .3 �3. (9) that the Department of Veterans' Affairs fully investigate all claims made in evidence to the Committee dealing with the alleged rudeness and unco-operative attitudes of its staff towards Vietnam veterans. If these claims are found to have substance, staff training policies should be reviewed as a matter of urgency (p. 177) ; (10) that the staff resources of the Department of Veterans' Affairs be increased so that more staff can be allocated to process claims and to personally attend to veterans' inquiries (p. 177); (11) that the Department of Veterans' Affairs implement a reverse charge telephone service for veterans living outside metropolitan areas to facilitate access to advice from the Department regarding the repatriation system (p. 178); (12) that the Department of Veterans' Affairs give high priority to improving the knowledge of local medical officers regarding the repatriation system and related matters, particularly the physical conditions of war service (p. 178) ; (13) that adequate staffing levels at the Vietnam Veterans Counselling Service be provided to enable the collection and publication of data on: The services provided; the number of clients and the types of problems presenting; and the outcome of the various treatment options available at the centres (p. 181); (14) that serious consideration be given to extending the Vietnam Veterans Counselling Service beyond 31 December 1983 (p. 181); (15) that the Department of Veterans' Affairs maintain statistical data relating to veterans serving prison sentences (p. 184); (16) that the Department of Veterans' Affairs approach the various state prison authorities to secure access to the Vietnam Veterans Counselling Service for Vietnam veterans serving prison sentences (p. 184); (17) that the proposed remodelling of the repatriation claims system be undertaken as a matter of urgency (p. 186) ; and (18) that the Department of Veterans' Affairs review and upgrade its data collection system and also complete the computerisation of its manual indexes (p. 188). � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 191 Folder The folder containing the original item. 5406 Series The series number of the original item. Series VIII Subseries I Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Date A point or period of time associated with an event in the lifecycle of the resource 1983 Title A name given to the resource Briefing Book for HVAC Subcommittee on Compensation, Pension and Insurance Hearing on H. R. 1961, Veterans Agent Orange Relief Act. April 26 and 27, 1983 and May 3, 1983 ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/405cce8f9a2f562af5193bc437aed08b.pdf 9936f414054ee7b8935a7ff35c636166 PDF Text Text Item D Number °5776 D ^t Scanned Author Corporate Author RBPOrt/ArtlGlB Title Briefing Notes: Briefing to Dr. Custis/Acting General Counsel, 11 Sept 1981 Journal/Book Title Yeer Month/Day Color D Number of Images ° Descripton Notes Thursday, March 28, 2002 Page 5776 of 5780 �BRIEFING NOTES 11 Sept 1981 Briefing to Dr. Custis/Acting General Counsel I. Agent Orange Events That Will Impact Upon VA University of Nebraska Fat Biopsy Report J.R.B. Literature Analysis DOD Information on RH Abort Missions A. Fat Biopsy Report TQDD levels from 20-186 ppt found in adipose tissue from three Vietnam veterans "heavily exposed" to Herbicide Orange. Other tissue samples from "non-exposed" Vietnam veterans and controls <[20 ppt. Significance Dr. Gross et al have probably distributed report. May expect Vietnam veterans and press to respond in very near future. VA Action Options 1. Take no action and write article for New England Journal of Medicine relating Dr. Gross's values to VA's description of exposure and supporting medical data. 2. Call Dr. Gross and explain "Scientific Method" or lack of in selecting individuals, determining exposure index, and no knowledge on "jobs" since Vietnam. Offer to incorporate medical data into "one," more complete manuscript. 3. Submit manuscript to Agent Orange Working Group (AOWG) Science Panel for evaluation and go public with evaluation. Submit medical data at same time. Following evalution, submit manuscript for publication. Advise Dr. Gross of action. May want to submit manuscript to Panel of VA Scientists. AOWG Science Panel meets 15 September 1981. B. JRB LITERATURE ANALYSIS JRB has been given extension of 15 days (to 30 September) to complete manuscript. Extension given to incorporate primary references, fat biopsy information (previously published) and review additional articles on cacodylic acid. �BRIEFING NOTES 11 Sept 1981 Briefing to Dr. Custis/Acting General Counsel (Continued) Significance Time delay may provide signal to vet groups on potential problems. However, VA interested only in a "First-Pate Report" from JRB. VA has not inputed to scientific assessment; rather has been instrumental in obtaining references unavailable to JRB. Preliminary review conducted by Major Young (unofficial and at JRB's request—to check completeness of 1iterature searches); his assessment is that the Literature Report will have significant impact. Report may "alarm" many groups because of volume of scientific data validating extreme toxicity and cellular persistance of TCDD. VA Response Options 1. Upon receipt of report, submit to appropriate Congressional committees and convene VA Advisory Group to receive thorough briefing on report. Prepare press releases. 2. Upon receipt, submit report to AOW3 Science Panel, VA Advisory Committee Membership (via mail) and to appropriate Congressional committees with letter explaining action. Input literature and VA Environmental Physicians attendance at Dioxin Symposiums to show "Continuing Education Process." C. POD Information on Ranch Hand Abort Missions On 10 September 1981, Major Young attended DOD/HHS meeting on new records uncovered by Army record search indicating that Ranch Hand aircraft aborted 92 times during period 1965-1971. During aborts entire contents (21,000 gallons) was jettisoned within 20-40 second. Many of these aborts occurred during take-offs from Ranch Hand bases (Bien H0a and Da Nang) and may have resulted in exposure of thousands of military personnel. HHS/DOD have brought in Dr. Pat Honchar (NIOSH) to review preliminary information and to make report to AOWG Science Panel on 15 Septemer. Significance Report to AOWG will mean report will go public. News media and vet groups will make "hay" since it may mean more veteans exposed then previously thought. Coupled with Dr. Gross biopsy report on TCDD in Vietnam veterans' fat, it may elicit response from Congress. Information will also complicate conduct of VA EPI Study on ground troops. May force EPI study of "Vietnam Experience." —3— �BRIEFING NOTES 11 Sept 1981 Briefing to Dr. Gustis/Acting General Counsel (Continued) RECOVIMENmTION Administrator and VA staff must be fully aware of situation and be prepared to make statements. Advise Administrator to indicate VA following BCD record search carefully and providing assistance as requested (note: Major Young and CHECO data). Also VA working on and with AOW3 Science Panel. � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 205 Folder The folder containing the original item. 5776 Series The series number of the original item. Series VIII Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Briefing Notes: Briefing to Dr. Custis/Acting General Counsel, 11 Sept 1981 ao_seriesVIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 185 Folder The folder containing the original item. 5371 Series The series number of the original item. Series VIII Subseries I Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Source A related resource from which the described resource is derived Pesticide and Toxic Chemical News Date A point or period of time associated with an event in the lifecycle of the resource March 17 1982 Title A name given to the resource Broad Reach of "Next" PCB Rules Indicated in EPA Court Ruling ao_seriesVIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 207 Folder The folder containing the original item. 5807 Series The series number of the original item. Series VIII Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Description An account of the resource <strong>Corporate Author: </strong>West Virginia Agent Orange Assistance Program Date A point or period of time associated with an event in the lifecycle of the resource 1983 Title A name given to the resource Brochure: Agent Orange ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/1da898c6e2e78f393c51f1d6ae74bc5c.pdf b58eac552584a15c95317f44201accdc PDF Text Text Kern D Number °5443 D Not Scanned Author Corporate Author Report/Article Title By Mr. Cranston: S 991. A bill to amend title 38, United States Code, to require regulations providing for the resolution of Veterans' Administration benefits claims based on certain exposures to herbicides containing dioxin, to ionizing radiation from detonations of nuclear devices, and to certain other purposes; to the Committee on Veterans' Affairs. Journal/Book TltlO Congressional Record - Senate Year 1983 Month/Day A ril 6 Color Number of Images P n ° Friday, March 15, 2002 Page 5443 of 5571 �April 6,1983 CONGRESSIONAL RECORD — SENATE effect on the date of the enactment of this Third, .to specify any presumptions Act or October 1, 1983, whichever is later,* regarding exposure and service-connection that the Administrator deter, By Mr. HEINZ: S. 990. A bill to extend the Export- mines should be applied to the resoluImport Bank Act of 1945, as amended; tion of the claims. to the Committee on Banking, Hous- Proposed regulations would be .required to be published in the Federal ing, and Urban Affairs. Register and to undergo the public EXTENSION OF EXPORT-IMPORT BANK ACT and comment process estab• Mr. HEINZ. Mr. President, at the review in the Administrative Procedure request of the administration, I am lished certain rulemaking processes. today introducing the President's pro- Act for This includes posed extension of the Export-Import that aprocess hearing be requirements public conducted at Bank Act. The bill consists of only one which interested parties have the opprovision—a 5-year extension of existportunity to present alternatives to ing law. In my judgment, this Is insufficient, the VA-proposed regulation and testiand on March 211 introduced my own mony and other evidence in support of proposal (S. 869) which contains a their positions and that the agency number of changes in the Bank's make findings and conclusions availacharter as well as a 6-year extension of ble and state the basis and reasoning the act. I would refer Senators to my therefor. statement of March 21 for details of 8. The Administrator's actions pursu869. On March 22 and 24 the Subcom- ant to these requirements and, very mittee on International Finance and importantly, the regulations themMonetary Policy conducted hearings selves would be subject .to judicial on the Bank, and I anticipate we will review in Federal court. Because the mark up renewal legislation later this Individual veteran's or survivor's claim is not subject to court review—almonth.* though our bill, S. 636, would correct By Mr. CRANSTON: this inequity—it is particularly appro8. 991. A bill to amend title 38, priate and important that the proceUnited States Code, to require regula- dures for deciding these claims be tions providing for the resolution of made reviewable. In this way, groups Veterans' > Administration benefits concerned about agent orange and raclaims based on certain exposures to diation issues would be afforded the herbicides containing dio'xin, to Ioniz- opportunity to have their day in court ing radiation from detonations of nu- if they were dissatisfied with and had clear devices, and to certain other haz- grounds to challenge either the fairardous Substances and for other pur- ness of the administrative process or poses; to the Committee on Veterans' the adequacy of the evidentiary basis Affairs. for the regulations. ADJUDICATION OF VETERANS' AGENT ORANGE AND With regard to the times at which RADIATION CLAIMS VA would be required to act, the Mr. CRANSTON. Mr. President, I the would require— am introducing today legislation bill publication of proposed dioxin The aimed at Improving the resolution by and radiation regulations not later the Veterans' Administration of claims for service-connected disability com- than 120 days after enactment of the pensation as a result of a veteran's ex- bill; posre in service to agent orange, ioniz- Repetition of the process with reCOMPENSATION FOR INJURIES INCURRED IN THE ing radiation, or other hazardous sub- spect to the dioxin regulations within 90 days after the submission of each PERFORMANCE OF DOTY BY MEMBERS OP THE stances used for military purposes. report required with respect to the CIVIL AIR PATROL SUMMARY OF THE BILL SEC. 603. (a) Section 8141 of title 5, United This legislation will require the Ad- Public Law 96-151-mandated epidemistudy on agency orange—the States Code,.is amended— ministrator of Veterans' Affairs to ological these reports is due 24 months (1) in subsection (a), by inserting "under issue, through a formal rulemaking first of 18 years of age" after "Civil Air Patrol process and subject to Judicial review, after OTA approval of the protocol Cadet"; and and subsequent reports are due annu(2) in subsection (bXl), by striking out regulations providing guidance for the ally thereafter; and "$300" and inserting in lieu thereof "the resolution of VA benefit claims—inFinal regulations within 90 days rate of basic pay payable for step 1 of grade cluding claims for compensation and OS-9 in the General Schedule under section other service-connected feenefitsr- after the end of each public review 5332 of this title". based on a disability resulting from ex- and comment period, each of which <bXl> The amendments made by subsec- posure in Vietnam to agent orange or must be for at least 30 days. tion (a) shall take effect on the date of the another herbicide containing dioxin, Mr. President, no specific deadlines enactment of this Act, exposure to ionizing radiation from a would be imposed with respect to haz(2) The amendment made by subsection ardous substances other than (aXl) shall apply only to deaths or injuries nuclear detonation, or exposure to cer- or radiation. However, resort todioxin court occurring on or after the date of the enact- tain other hazardous substances. * The regulations would.be expressly would be available to compel action if ment of this Act. the Administrator were to refuse to (3) The amendment made by subsection requiredFirst, to give full effect to a present develop and publish regulations with (a)(2) shall apply only to the computation of compensation payable for periods com- title 38 provision, section 354(b), respect to other substances used for mencing on or after the date of the-enact- which, as interpreted by the VA, re- military purposes to which significant ment of this Act. quires the Administrator to "resolve numbers of veterans were exposed and TITLE VII—EFFECTIVE DATE every reasonable doubt in the favor of as to which the state of available medical and scientific evidence makes the veteran." EFFECTIVE DATE Second, to contain guidelines, stand- it impossible to determine whether SEC. 701, Except as otherwise provided in this Act, the provisions of this Act and ards, and criteria for resolving the their exposure has caused certain disamendments made by this Act shall take claims involved. .,-..--. eases. * 84198 if such disclosure is not specifically prohibited by law and if the Information is not specifically required by or pursuant to executive order to be kept secret in the interest of national defense or the conduct of foreign affairs; or "<2> a disclosure by such an employee or applicant to any civilian employee, nonappropriated fund instrumentality employee, or member of the armed forces designated by law or by the Secretary concerned to receive disclosures described in clause (1), of information which the employee or applicant believes evidences— "(A) a violation of any law, rule, or regulation; or '. "(B) mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety. "(c) This section does not apply to an employee in a position excluded from the coverage of this section by the President based upon a determination by the President that the exclusion is necessary and warranted by conditions of good administration. "(d) The Secretary of Defense shall be responsible for the prevention of actions prohibited by subsection (b) and for the correction of any such: actions that are taken. The authority of the Secretary to correct such actions may not be delegated to the Secretary of a military department or to the Assistant Secretary of Defense for Manpower, Reserve Affairs, and Logistics. ' "(e) The Secretary of Defense, after consultation with the Director of the Office of Personnel Management and the Special Counsel of the Merit Systems Protection | Board, shall prescribe regulations to carry out this section. Such regulations shall include provisions to protect the confidentiality of employees and applicants making disclosures described in clauses (1) and (2) of subsection <b).", (2) The table of sections at the beginning of such chapter is amended by adding at the end thereof the following new item: "1587. Employees of nonappropriated fund instrumentalities.", (b) Section 1587 of such title, as added by subsection (a), shall apply with respect to any conduct prohibited by subsection (b) of such section which occurs after the date of the enactment of this Act. �S4199 CONGRESSIONAL RECORD — SENATE resolution of radiation-exposure have endured. Through various efforts—including writing laws to manMr. President, the time for this leg- claims. Moreover, this morning's hearing on date scientific studies and provide islation dearly has arrived. Many of my colleagues may recall that. In Sep- radiation-exposure issues before the them with health care, conducting tember 1980, ttie Senate passed some- Veterans' Affairs Committee demon- oversight hearings and other monitorwhat similar legislation with respect strated to all present, I believe, that ing activities, and assisting with indionly to agent orange that my friend the Veterans' Administration has no vidual cases—I have tried to help these and colleague from Pennsylvania (Mr. dear guidance or standards governing; veterans. HEINZ) and I, together, with eight of or even practices routinely applied or I believe that further steps need to our colleagues, including the -present, followed in, the adjudication of radi- be taken m this effort and taken now, very able chairman of the Veterans' ation-exposure cases. The situation on and I urge my colleagues to support Affairs Committee (Mr. SIMPSON) this point can best be characterized as this legislation to see that that these sponsored—imprinted amendment No. in a fundamental state of disarray, steps are indeed taken. 1550 to S. 1188. Thereafter, in 1981, and clarifying regulations are urgently Mr. President, I ask unanimous consent that the text of S. 991 be printed under the chairmanship of the Sena- needed. tor from Wyoming (Mr. SIMPSON), the I believe this legislation is also an ta the'RECORD at this point. Veterans' Affairs Committee reported appropriate approach to the difficul- There being no objection, the bill and the Senate passed on June 16, ties veterans encounter in their claims was ordered to be printed in the from exposure 1961, identical legislation as part of S. for disabilities resulting to certain haz- RECORD, as follows: during military service 921/H.E. 3499. S,fl91 in The only major distinction with re- ardous substances and.connection with: Be it enacted by the Senate and House of purposes as to which the spect to the agent orange issue be- military medical and scientific evidence Representatives of the United States of tween the 1980 and 1981 Senate-passed state of to the effects of exposure Is America in Congress assembled, That (a) legislation and the bm I am introduc- relating The legislation, which reflects Section 354 of title 38, United States Code, is amended— ing today is that the Administrator, unclear. of fairness . and under the proposed bill, would be re- basic , notions by providing for simi- CD in subsection <W— beginning with "In" evenhandedness <A) by striking out all quired to develop regulations relating through "expedition, the" types to the resolution of claims based on lar treatment of all based of claims for lieu thereof ."The"; and and inserting in service connection on exposure exposure to agent orange in advance to those kinds of environmental haz- <B) by striking out "such service" the first oi the results of the epidemiotogical ards—whether the hazard is dioxin, ra- place it occurs and inserting in lieu thereof study mandated by Public Law 96-151. diation, or some other hazard encoun- "a veteran's service en active' duty"; and The requirements once the results of tered as a result of military action— <2> by addtag at the end the following new that study become available, would be where a causal relationship between subsection: "(cXIMA) The regulations required the same. ' . • / exposure and claimed disabilities prescribed by subparagwph (B) of this to be paraUSED FOR THE LECIStATION cannot be established on the basis of graph shall— Mr. President, requiring the develop- available evidence, has several advan- "(i) establish guidelines, standards, and criteria for the resolution of claims for ment of regulations before study re- tages. sults are available may be viewed as first, the. bill, by setting in motion a, benefit* under laws administered by the the benefit premature. As an earlier point, I would process that is designed to produce Veterans' Administration whererequirement eligibility criteria include a have agreed and I, in fact, did. Howev- close scrutiny of available evidence re- that a death or disability be service connecter, the epidemiologieal study to deter- garding the effects of exposure to the claim of service-connection U mine the health of Vietnam veterans various hazard^ and consideration of ed and theveteran's exposure during sendee baaed cm a exposed to agent orange was mandat- guidelines to govern the resolution of OB active duty— ed ' by law to December Iff79. Now, claims, would 'Insure that the VA fo- "(I) in the Republic of Vietnam during nearly 3% years later, the study still cuses clearly on these issues. the Vietnam era, to a herbicide containing has not been started. Indeed, its proto- Second, it would make the process of dioxin, col has not yet been approved. Tne adjudicating veterans' claims for bene- "tll> in connection with the veteran's participation in the test of a nuclear device or Congress should not wait any longer fits for such exposure an open one and with the American occupation of Hiroshima t& require the executive branch to invite public involvement. In cases in- or Nagasaki, Japan, prior to July 1,1946* to make specific determinations—in a volving exposure to these hazardous ionizing radiation from the detonation of a publicly accountable, judicially re- substances—in which causation is dif- nuclear device, or viewable process—oh guidelines to ficult to establish and in which the "(III) to another hazardous substance; govern resolution of agent orange ex- VA, because there is not Judicial and i posure claims. review of VA decisions, has the final "(11) enaure that subsection (b) of this sec1 have reached the same conclusion say—the process of developing adjudi- tion is given full effect with respect to such in the area of radiation-exposure cation guidelines should be carried out claims. Tbe Administrator, in accordance "(B) claims. Nearly 4 years ag©> the VA in public view and with public partici- with paragraph (2> (A) and (B) of this subagreed to develop guidelines for the pation. regularesolution of these claims. In carrying Finally, the bill would transfer from section, shall develop and publish Prompttions implementing this subsection. out that commitment, however, the Congress, to a more appropriate arena ly after each occasion on which the Adminagency provided no opportunity for some very technical Judgments and. istrator prescribes or amends the substance public participation. The agency's analyses that Congress Is .ill-qualified of any such regulations,, the Administrator action was challenged in a lawsuit to make and should undertake to shall submit to the appropriate committees filed in 1980. The trial court ruled make only after the executive branch of the Congress a, report containing any recagainst the agency and the matter is has made clear, and clearly inequitable ommendations for legislative action, including proposed amendments to section 312 of presently before the U.S. Court of Ap- determinations. . this title, if any, that the Administrator CONCLUSION * , peals for the District of Columbia Circonsiders appropriate in light of such guidecuit. During the pendency of this liti- In my duties as a member of the lines, standards, and criteria. gation, the status of the guidelines has Veterans' Affairs Committee over the "(C) Regulations, developed and published not been clear, and the agency has last 12 years, serving for 4 years as pursuant to subparagraph (B) of this paramaintained its opposition, to public chairman and now as ranking minority graph'shall include-specification of any preparticipation, a position that I find in- member, I have seen the many diffi- sumptions (including any presumptions regarding exposure and service-connection) to explicable. Enactment of the proposed culties which veterans exposed during be applied to the resolution of the claims to measure would settle this dispute by their service to agent orange and radi- which the guidelines, standards, and criteria requiring the VA, with public partici- ation have had. I sympathize greatly in such regulations apply. . " pation and in a publicly accountable with these veterans and their loved "C2XAKD The Administrator shall develop process, to develop guidelines for the ones and the anguish many of them the regulations required by paragraph (1) of April 6,1983 PRECEDENT FOR THE UBISLATXON �S4200 CONGRESSIONAL RECORD — SENATE this subsection through a public review and comment process In accordance with the provisions of sections 553 (b) and (e), 556, and 557 of title 5. "(ii) Not later than one hundred and twenty days after the date of the enactment of this subsection, the Administrator shall develop and publish in the Federal Register, for public review and comment for a period of not less than thirty days, a proposed version of the regulations required by such paragraph for the resolution of claims for service-connection based on exposures specified in subclauses (I) and (II) of subparagraph (A)(i> of such paragraph. "<B> Not later than ninety days after the end of each such period of public review and comment, the Administrator shall publish in the Federal Register final regulations containing the guidelines, stan'dards, and criteria (together with explanations of the bases for such guidelines, standards, and criteria) for resolving the claims involved. "(C) The Administrator's compliance with the provisions of, and any regulations prescribed pursuant to, this subsection shall be subject to judicial review 4 accordance with in the provisions of chapter ? of title 5. "(3) For the purposes of this subsection, the term 'hazardous substance' means a substance with respect to which the Administrator determines, pursuant to the regulations required by paragraph (1) of this subsection, that— "(A) a significant number of veterans were exposed (i) while serving on active duty, and (ID as the result of (!) the use of such substance by a branch of the Armed Forces for military purposes, including training and testing programs, or (II) the action of a hostile force; and "(B) there is insufficient medical or scientific evidence (1) tfc determine whether exposure to the substance causes a disease which has resulted in a disability in the cases of a significant number of veterans, or (ii) to determine whether a level (or range of levels) of exposure experienced by significant numbers of veterans is sufficient to cause such disease.". (b) Paragraph (3) of section 307(b) of the Veterans' Health Programs Extension and Improvement Act of 1S79 (Public Law 96151; 93 Stat, 1097), as added by section 401(b)(2) of the Veterans' Health Care, Training, and Small Business Loan Act of 1981 (Public Law 97-72; 95 Stat. 1061), is amended to read as follows: , • "(SKA) Not later than ninety days after the submission of each report under paragraph (2), the Administrator shall, based on the results described In such report and the comments and recommendations included therein and any other available pertinent information, develop and publish in the Federal Register, for public review and comment, .a proposed version of the regulations required by paragraph (1) of subsection <c> of section 354 of title 38, United States Code, for. the resolution of claims for service-connection based on the exposure specified in subparagraph (BX1XI) of such paragraph. • "(B> The Administrator's actions to comply with the provisions of subparagraph (A) shall be subject to the provisions of paragraph (2) of section 354(c) of such title as though such actions were required by such section.". ••••aim-n By Mr. CRANSTON: 8. 992. A bill to amend title 38, United States Code, to establish an emergency Job retraining and employment program for veterans; to the Committee on Veterans' Affairs. VETERANS EMERGENCY RETRAINING ACT OF 1983 Dr. CRANSTON. Mr. President, I am "Introducing today, as the ranking minoVity member of the Committee on Veterans' Affairs, S. 992, the proposed VeteraHs Emergency Retraining Act of 1983. This measure would amend title 38, United. States Code, to establish an emergencySjob retraining and employment program for veterans. April 6,1983 .land Industries working as machinists, welders and pipefitters. By contrast, hign-technology jobs are proving elusive. Just/iour of 25 workers who completed a nine-month robotics course In December have fcmnd jobs. Approvable training programs could be programs conducted by (educational institutions under arrangements or agreements with employers as well as training programs, including on-theJob training, conducted^by the employDESCRIPTION or 8. «sz: "VERA" Eligibility: TJhe proposed Veterans er directly. In addition, all programs Emergency Retraining Act—VERA— that are VA-approv/d for apprenticewould focus on the needs of two cate- ship or other on-jols training purposes gories of wartimeVeterans: those who under the current/GI bill, chapter 34, are long-term unemployed—that is, would be considered to be approved those who have been, out of work for for this new program. Payments: Umier VERA, Mr. Presi15 out of 20 weeks preceding application for the programVand veterans dent, employers hiring and training who have been laid off qr terminated eligible vetersms in approved training from a job to which theySare unlikely programs would receive quarterly payto be able to return. These veterans ments of ^retraining assistance" on would be entitled to participate in the behalf of tfie veteran. These payments program established by VER* for up would be Jnade after each 3 months of to 12-month; sendce-connecwd dis- training if/as certified and be the lesser abled veterans with disability ratings of the following amounts: 50 percent of 30 percent or more could have\that of the/wages paid to the veteran by 12 months period extended by an addi- the employer or an amount, based on tional 6 months. All veterans who an aiinual rate of $6,000—or, in the ever obtained entitlement to GI case/of a 30-percent or more servicetraining—under the World War iccted disabled veteran, on an Korean conflict, or post-Korea/Viet-1 tual rate of $9,000. These payments nam-era GI bill programs—would be Id be deemed to compensate the eligible for the program. iployer for the costs of training the Duration: The program established teran and for the reduced productivby VERA would be of a limited dura- ' ity\of the veteran during the training tion, similar to the fixed-time exten period. sion of the delimiting period of cei ctions: The criteria for approvVietnam-era veterans enacted ing training programs under VERA, Public Law 97-72 in 1981—theso- Mr. President, as set forth in proposed called targeted delimiting date author- new section 1950(b) of title 38, are deity. Under VERA, no assistance/could signed to\protect the integrity be made available on behalf of tt veter- training while at the same time of the not to an for a training program that does be onerouis for potential employers. not start within 30 months following Protectionsuiave been incorporated to the month in which VERA is enacted. avoid' "substitution"—that is, an emTraining programs: Training proan artificial vacancy grams eligible for approval under ployer creatingregular employee so as laying off 4 VERA would be those m "sustained- by take advantage of the retraining asto demand skill areas"—that is, areas of sistance payment—and to help insure the labor market determined by the to a permanent Secretary of Labor to/nave a high po- that the trainingveadsprohibitions on job. Other standard tential for sustaii/ed growth or certain types of training for jobs that demand. These areas could include, but would not necessarily be limited are seasonal, religious, or political in to, high-technology-related sectors. It nature and limitations on receipt of asshould be noted/In this regard that sistance under otherWograms are inmany "sustained/demand" Job training cluded in new section)! 1952 and 1953, recovery opportunities might be found in more respectively. Liability for and provided have^been traditional areas, depending on the of overpayments 1955. locale and particular {tabor markets. for in new section IMPLEMENTATION PRO DOTES That jobs would not be limited to socalled high/tech areas is aptly illusMr. President, under the proposed trated by toe following excerpt from a VERA, the VA and the Department of March. 30,/1983, Wall Street Journal Labor would have interrelated responarticle describing, an on-Job training sibilities for implementing \the proprogram/in the Detroit, Mich,, area gram. The VA would be responsible that pays employers half of employee for the actual payment to employers wages during training: of the quarterly retraining assistance The agency combs the local job market after each 3 months of training. Tofor openings that require the newly learned gether, the .Administrator and\the skills. Michael White got a job maintaining ASVE would be required to conduct apartments soon after completing a course public information and outreach ujiin building management, and he has already tiatives to inform veterans and en gotten an offer for the type of management job Ahat would restore the income he made ployers, as well as unions, trade assocP ations, and educational institutions of as tut auto worker. Cost of those who have retrained success- opportunities made available by VERA fully have found Jobs in traditional heart- and to stimulate business, union, and � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 192 Folder The folder containing the original item. 5443 Series The series number of the original item. Series VIII Subseries I Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Source A related resource from which the described resource is derived Congressional Record - Senate Date A point or period of time associated with an event in the lifecycle of the resource April 6 1983 Title A name given to the resource By Mr. Cranston: S 991. A bill to amend title 38, United States Code, to require regulations providing for the resolution of Veterans' Administration benefits claims based on certain exposures to herbicides containing dioxin, to ionizing radiation from d ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/a1d62170974d239c6d364fb3a50ec9b4.pdf 5361be2589d9bf6e1dd6ea7866ab1043 PDF Text Text Item D Number OSSSQ . Author Corporate Author Report/Article Title Calculations for the Adipose Tissue Study [n.d.] Journal/Book Title Year Month/Day Color Number of Images D ° Handwritten notes and calculations by Alvin L. Young. Tuesday, April 02, 2002 Page 5839 of 5840 �Uuvy, /**»**••£<- <A n A \SSU .p �Vf — 1-1--1--M L. . /c �••w M ¥ > u 1 1^ I^v3 r n^r ^L **<] (. 1 -7 Y iy r *1 'I (1C *VC lU 6*^ \l �to fr-f r.o T-WA-U o t V l«* I** 5 ••••?•-«•• <./•« 16. f ��t ,7 ofc i i �-<- 1 •» -Jr, 4? HT r �, ^ —• J? / "5? 9 f" ' O-.-*^ �s " ti Vi rl -f �^ �"' - - • / � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 208 Folder The folder containing the original item. 5839 Series The series number of the original item. Series VIII Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Calculations for the Adipose Tissue Study [n.d.] ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/ed66230bde71b097bba771fb7ba45e5c.pdf c811b2cb0ea19cdef0c071398b2fb8cc PDF Text Text 05432 Author Corporate Author RBpOrt/ArtlCiO TitlB California Assembly Joint Resolution No. 48 - Relative to veterans exposed to Agent Orange Journal/Book Title Year 1983 Month/Day Color D Number of Images ° DBSCrlptOn NotBS Includes cover letter from James D. Driscoll to the United States Veterans Administration (VA), September 8, 1983 Friday, March 15, 2002 Page 5432 of 5571 �State Capitol Sacramento, California 95814 Telephone: 445-3614 jr JAMES D. DRISCOLL CHIEF CLERK September 8, 1983 United States Veterans' Administration Department of Medicine and Surgery Washington, D.C. 20420 Gentlemen: I have been directed to invite your attention to Assembly Joint Resolution No. 48, relative to veterans exposed to Agent Orange. Accordingly, I am enclosing a copy of this resolution for your information. Very truly yours, JAMES D. DRISCOLL Chief Clerk JDD:mk Enclosure �'.I . •> Assembly Joint Resolution No. 48 Adopted in Assembly June 30, 1983 Chief Clerk of the Assembly Adopted in Senate August 30, 1983 Secretary of the Senate This resolution was received by the Secretary of State this at day of o'clock , 1983, M. Deputy Secretary of State i o �AJR 48 — 2— RESOLUTION CHAPTER Assembly Joint Resolution No. 48—Relative to veterans exposed to Agent Orange. LEGISLATIVE COUNSEL'S DIGEST AJR 48, Nolan. Vietnam veterans: Agent Orange exposure. This measure would memorialize the President and Congress to support and enact legislation directing the United States Veterans' Administration to pay compensation to an estimated 3,000 Vietnam veterans who were exposed to Agent Orange during service in Vietnam and who suffer from liver disorders, skin conditions, and soft-tissue cancer. WHEREAS, The United States Veterans' Administration has recently announced that it is opposed to any proposal to grant compensation to any of the approximately 3,000 Vietnam veterans suffering illnesses that may be related to their exposure to the herbicide Agent Orange during their Vietnam duty more than a decade ago; and WHEREAS, This defoliant chemical was sprayed extensively by United States forces in Vietnam between 1965 and 1971 to kill jungle growth concealing enemy movements, and its long-term effects were then unknown; and WHEREAS, Extensive studies have shown a causal relationship between dioxin, a major component of Agent Orange, and three illnesses—a liver disorder, a skin condition, and a soft-tissue cancer; and WHEREAS, This unreasonable attitude toward these 3,000 ill veterans is inconsistent with the government's recent decision to award compensation to the residents of Times Beach, Missouri, who have suffered dioxin contamination; and WHEREAS, Legislation is pending before Congress which would award compensation, based on severity of illness, to these 3,000 suffering veterans; now, therefore, 97 60 �— 3— AJR 48 be it Resolved by the Assembly and Senate of the State of California jointly, That the Legislature of the State of California respectfully memorializes the President and Congress of the United States to support and enact legislation directing the United States Veterans' Administration to pay compensation to the estimated 3,000 Vietnam veterans who suffer from liver disorders, skin conditions, and soft-tissue cancer having a strong correlation to exposure to Agent Orange during their service in Vietnam; and be it further Resolved, That the United States Veterans' Administration fulfill the intent of the Starbuck Memorandum dated April 3, 1980, which states that "given the considerable uncertainties as to the disposition of defoliants in Southeast Asia and troop positions at pertinent times, the Veterans' Administration will accept, in the absence of positive evidence to the contrary, a Vietnam Veteran's Contention of Exposure," and with all due and deliberate speed will provide physical examinations to those veterans exposed to Agent Orange during the Vietnam War; and be it further Resolved, That the Chief Clerk of the Assembly transmit copies of this resolution to the President and Vice President of the United States, to the Speaker of the House of Representatives, to each Senator and Representative from California in the Congress of the United States, and to the United States Veterans' Administration. 97 70 � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 192 Folder The folder containing the original item. 5432 Series The series number of the original item. Series VIII Subseries I Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Date A point or period of time associated with an event in the lifecycle of the resource 1983 Title A name given to the resource California Assembly Joint Resolution No. 48 - Relative to veterans exposed to Agent Orange ao_seriesVIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 201 Folder The folder containing the original item. 5682 Series The series number of the original item. Series VIII Subseries II Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Jemison, Terry Source A related resource from which the described resource is derived U. S. Medicine Date A point or period of time associated with an event in the lifecycle of the resource 1986-04-01 Title A name given to the resource CDC-Army Breakdown Stalls Study ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/812b55b685d5c99253ff099ccf3423f0.pdf c3adc0ef4521cc5c890dba96ea4285ac PDF Text Text Item D Number °5347 D Not Scanned Author United States Environmental Protection Agency (EPA) Raport/ArtlClB TitlB CERCLA: Comprehensive Environmental Response, Compensation, and Liability Act of 1980. Journal/Book Title Year 198 Month/Day December 11 Color Number of lmao.es ° D ° Descripton Notes Tuesday, March 05, 2002 Page 5347 of 5363 �United States Environmental Protection Agency f/EPA CERCLA Comprehensive Environmental Response, Compensation, and Liability Act of 1980 �PUBLIC LAW 96-510—DEC. 11,1980 Public Law 96-510 96th Congress 94 STAT. 2767 An Act Dec. 11, 1980 [H.B. 7020] To provide for liability, compensation, cleanup, and emergency response for hazardous, substances released into the environment and the cleanup of inactive hazardous waste disposal sites. Be it enacted by the Senate and House of Representatives of the United States of American in Congress assembled, That this Act may be cited as the Comprehensive Environmental Response, Compensation, and Liability Act of 1980". TITLE I—HAZARDOUS SUBSTANCES RELEASES, LIABILITY, COMPENSATION Comprehensive Environmental Response, Compensation, and Liability Act of 1980 42 USC 9601 note. DEFINITIONS SEC. 101. For purpose of this title, the term— (1) "act of God" means an unanticipated grave natural disaster or other natural phenomenon of an exceptional, inevitable, and irresistible character, the effects of which could not have been prevented or avoided by the exercise of due care or foresight; (2) "Administrator" means the Administrator of the United States Environmental Protection Agency; (3) "barrel" means forty-two United States gallons at sixty degrees Fahrenheit; (4) "claim" means a demand in writing for a sum certain; (5) "claimant" means any person who presents a claim for compensation under this Act; (6) "damages" means damages for injury or loss of natural resources as set forth in section 107(a) or lll(b) of this Act; (7) "drinking water supply" means any raw or finished water source that is or may be used by a public water system (as defined in the Safe Drinking Water Act) or as drinking water by one or more individuals; (8) "environment" means (A) the navigable waters, the waters of the contiguous zone, and the ocean waters of which the natural resources are under the exclusive management authority of the United States under the Fishery Conservation and Management Act of 1976, and (B) any other surface water, ground water, drinking water supply, land surface or subsurface strata, or ambient air within the United States or under the jurisdiction of the United States; (9) "facility" means (A) any building, structure, installation, equipment, pipe or pipeline (including any pipe into a sewer or publicly owned treatment works), well, pit, pond, lagoon, impoundment, ditch, landfill, storage container, motor vehicle, rolling stock, or aircraft, or (B) any site or area where a hazardous substance has been deposited, stored, disposed of, or placed, or otherwise come to be located; but does not include any consumer product in consumer use or any vessel; 42 USC 9601, 42 use 201 note. 16 USC 1801 note. �94 STAT. 2768 33 use 1342. 33 USC 1344. 42 USC 6925. 33 USC 1412, 1413. 42 USC 300. 42 USC 7411, 7412, 7470, 7501, 42 USC 7410., 33 USC 1317. 33 USC 1342. 42 USC 2014. Post, p. 2801. Post, p. 2804. PUBLIC LAW 96-510—DEC. 11, 198d (10) "federally permitted release" means <A) discharges in compliance with a permit under section 402 of the Federal Water Pollution Control Act, (B) discharges resulting from circumstances identified and reviewed and made part of the public record with respect to a permit issued or modified under section 402 of the Federal Water Pollution Control Act and subject to a condition of such permit, (C) continuous or anticipated intermittent discharges from a point source, identified in a permit or permit application under section 402 of the Federal Water Pollution Control Act, which are caused by events occurring within the scope of relevant operating or treatment systems, (D) discharges in compliance with a legally enforceable permit under section 404 of the Federal Water Pollution Control Act, (E) releases in compliance with a legally enforceable final permit issued pursuant to section 3005 (a) through (d) of the Solid Waste Disposal Act from a hazardous waste treatment, storage, or disposal facility when such permit specifically identifies the hazardous substances and makes such substances subject to a standard of practice, control procedure or bioassay limitation or condition, or other control on the hazardous substances in such releases, (F) any release in compliance with a legally enforceable permit issued under section 102 of section 103 of the Marine Protection, Research, and Sanctuaries Act of 1972, (G) any injection of fluids authorized under Federal underground injection control programs or State programs submitted for Federal approval (and not disapproved by the Administrator of the Environmental Protection Agency) pursuant to part C of the Safe Drinking Water Act, (H) any emission into the air subject to a permit or control regulation under section 111, section 112, title I part C, title I part D, or State implementation plans submitted in accordance with section 110 of the Clean Air Act (and not disapproved by the Administrator of the Environmental Protection Agency), including any schedule or waiver granted, promulgated, or approved under these sections, (I) any injection of fluids or other materials authorized under applicable State law (i) for the purpose of stimulating or treating wells for the production of crude oil, natural gas, or water, (ii) for the purpose of secondary, tertiary, or other enhanced recovery of crude oil or natural gas, or (iii) which are brought to the surface in conjunction with the production of crude oil or natural gas and which are reinjected, (J) the introduction of any pollutant into a publicly owned treatment works when such pollutant is specified in and in compliance with applicable pretreatment standards of section 307 (b) or (c) of the Clean Water Act and enforceable requirements in a pretreatment program submitted by a State or municipality for Federal approval under section 402 of such Act, and (K) any release of source, special nuclear, or byproduct material, as those terms are defined in the Atomic Energy Act of 1954, in compliance with a legally enforceable license, permit, regulation, or order issued pursuant to the Atomic Energy Act of 1954; (11) "Fund" or "Trust Fund" means the Hazardous Substance Response Fund established by section 221 of this Act or, in the case of a hazardous waste disposal facility for which liability has been transferred under section 107(k) of this Act, the Post-closure Liability Fund established by section 232 of this Act; (12) "ground water" means water in a saturated zone or stratum beneath the surface of land or water; �PUBLIC LAW 96-510-DEC. 11, 1980 94 STAT. 2769 (13) "guarantor" means any person, other than the owner or operator, who provides evidence of financial responsibility for an owner or operator under this Act; (14) "hazardous substance" means (A) any substance designated pursuant to section 311(bX2XA) of the Federal Water Pollution Control Act, (B) any element, compound, mixture, solution, or 33 USC 1321. substance designated pursuant to section 102 of this Act, (C) any hazardous waste having the characteristics identified under or listed pursuant to section 3001 of the Solid Waste Disposal Act 42 use 6921. (but not including any waste the regulation of which under the Solid Waste Disposal Act has been suspended by Act of Congress), (D) any toxic pollutant listed under section 307(a) of the Federal Water Pollution Control Act, (E) any hazardous air pollutant listed under section 112 of the Clean Air Act, and (F) any 42 use 7412. imminently hazardous chemical substance or mixture with respect to which the Administrator has taken action pursuant to section 7 of the Toxic Substances Control Act. The term does not is use 2606. include petroleum, including crude oil or any fraction thereof which is not otherwise specifically listed or designated as a hazardous substance under subparagraphs (A) through (F) of this paragraph, and the term does not include natural gas, natural gas liquids, liquefied natural gas, or synthetic gas usable for fuel (or mixtures of natural gas ana such synthetic gas); (15) "navigable waters" or "navigable waters of the United States" means the waters of the United States, including the territorial seas; (16) "natural resources" means land, fish, wildlife, biota, air, water, ground water, drinking water supplies, and other such resources belonging to, managed by, held in trust by, appertaining to, or otherwise controlled by the United States (including the resources of the fishery conservation zone established by the Fishery Conservation and Management Act of 1976), any State or 16 USC 1801 note. local government, or any foreign government; (17) "offshore facility" means any facility of any kind located in, on, or under, any of the navigable waters of the United States, and any facility of any kind which is subject to the jurisdiction of the United States and is located in, on, or under any other waters, other than a vessel or a public vessel; (18) "onshore facility" means any facility (including, but not limited to, motor vehicles and rolling stock) of any kind located in, on, or under, any land or nonnavigable waters within the United States; (19) "otherwise subject to the jurisdiction of the United States" means subject to the jurisdiction of the United States by virtue of United States citizenship, United States vessel documentation or numbering, or as provided by international agreement to which the United States is a party; (20XA) "owner or operator" means (i) in the case of a vessel, any person owning, operating, or chartering by demise, such vessel, (ii) in the case of an onshore facility or an offshore facility, any person owning or operating such facility, and (iii) in the case of any abandoned facility, any person who owned, operated, or otherwise controlled activities at such facility immediately prior to such abandonment. Such term does not include a person, who, without participating in the management of a vessel or facility, holds indicia of ownership primarily to protect his security interest in the vessel or facility; �94 STAT. 2770 42 USC 2011 note. 42 USC 2210. 42 USC 7912, 7942. 42 USC 5121 note. PUBLIC LAW 96-510—DEC. 11, 1980 (B) in the case of a hazardous substance which has been accepted for transportation by a common or contract carrier and except as provided in section 107(a) (3) or (4) of this Act, (i) the term "owner or operator" shall mean such common carrier or other bona fide for hire carrier acting as an independent contractor during such transportation, (ii) the shipper of such hazardous substance shall not be considered to have caused or contributed to any release during such transportation which resulted solely from circumstances or conditions oeyond his control; (C) in the case of a hazardous substance which has been delivered by a common or contract carrier to a disposal or treatment facility and except as provided in section 107(a) (3) or (4) (i) the term "owner or operator" shall not include such common or contract carrier, and (ii) such common or contract carrier shall not be considered to have caused or contributed to any release at such disposal or treatment facility resulting from circumstances or conditions beyond its control; (21) "person" means an individual, firm, corporation, association, partnership, consortium, joint venture, commercial entity, United States Government, State, municipality, commission, political subdivision of a State, or any interstate body; (22) "release" means any spilling, leaking, pumping, pouring, emitting, emptying, discharging, injecting, escaping, leaching, dumping, or disposing into the environment, but excludes (A) any release which results in exposure to persons solely within a workplace, with respect to a claim which such persons may assert against the employer of such persons, (B) emissions from the engine exhaust of a motor vehicle, rolling stock, aircraft, vessel, or pipeline pumping station engine, (C) release of source, byproduct, or special nuclear material from a nuclear incident, as those terms are defined in the Atomic Energy Act of 1954, if such release is subject to requirements with respect to financial protection established by the Nuclear Regulatory Commission under section 170 of such Act, or, for the purposes of section 104 of this title or any other response action, any release of source byproduct, or special nuclear material from any processing site designated under section 102(aXD or 302(a) of the Uranium Mill Tailings Radiation Control Act of 1978, and (D) the normal application of fertilizer; (23) "remove" or "removal" means the cleanup or removal of released hazardous substances from the environment, such actions as may be necessary taken in the event of the threat of release of hazardous substances into the environment, such actions as may be necessary to monitor, assess, and evaluate the release or threat of release of hazardous substances, the disposal of removed material, or the taking of such other actions as may be necessary to prevent, minimize, or mitigate damage to the public health or welfare or to the environment, which may otherwise result from a release or threat of release. The term includes, in addition, without being limited to, security fencing or other measures to limit access, provision of alternative water supplies, temporary evacuation and housing of threatened individuals not otherwise provided for, action taken under section 104(b) of this Act, and any emergency assistance which may be provided under the Disaster Relief Act of 1974; (24) "remedy" or "remedial action" means those actions consistent with permanent remedy taken instead of or in addition to removal actions in the event of a release or threatened release of �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2771 a hazardous substance into the environment, to prevent or minimize the release of hazardous substances so that they do not migrate to cause substantial danger to present or future public health or welfare or the environment. The term includes, but is not limited to, such actions at the location of the release as storage, confinement, perimeter protection using dikes, trenches, or ditches, clay cover, neutralization, cleanup of released hazardous substances or contaminated materials, recycling or reuse, diversion, destruction, segregation of reactive wastes, dredging or excavations, repair or replacement of leaking containers, collection of leachate and runoff, onsite treatment or incineration, provision of alternative water supplies, and any monitoring reasonably required to assure that such actions protect the public health and welfare and the environment. The term includes the costs of permanent relocation of residents and businesses and community facilities where the President determines that, alone or in combination with other measures, such relocation is more cost-effective than and environmentally preferable to the transportation, storage, treatment, destruction, or secure disposition offsite of hazardous substances, or may otherwise be necessary to protect the public health or welfare. The term does not include offsite transport of hazardous substances, or the storage, treatment, destruction, or secure disposition offsite of such hazardous substances or contaminated materials unless the President determines that such actions (A) are more cost-effective than other remedial actions, (B) will create new capacity to manage, in compliance with subtitle C of the Solid Waste Disposal Act, hazardous substances in addition to those located at the affected facility, or (C) are necessary to protect public health or welfare or the environment from a present or potential risk which may be created by further exposure to the continued presence of such substances or materials; (25) "respond" or "response" means remove, removal, remedy, and remedial action; (26) "transport" or "transportation" means the movement of a hazardous substance by any mode, including pipeline (as defined 49 in the Pipeline Safety Act), and in the case of a hazardous use 1671 substance which has been accepted for transportation by a " common or contract carrier, the term "transport" or "transportation" shall include any stoppage in transit which is temporary, incidental to the transportation movement, and at the ordinary operating convenience of a common or contract carrier, and any such stoppage shall be considered as a continuity of movement and not as the storage of a hazardous substance; (27) "United States" and "State" include the several States of the United States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, American Samoa, the United States Virgin Islands, the Commonwealth of the Northern Marianas, and any other territory or possession over which the United States has jurisdiction; (28) "vessel" means every description of watercraft or other artificial contrivance used, or capable of being used, as a means of transportation on water; (29) "disposal", "hazardous waste", and "treatment" shall have the meaning provided in section 1004 of the Solid Waste Disposal Act; 42 use 6903. �94 STAT. 2772 33 use 1362. 33 use 1321. PUBLIC LAW 96-510—DEC. 11, 1980 (30) "territorial sea" and "contiguous zone" shall have the meaning provided in section 502 of the Federal Water Pollution Control Act. (31) "national contingency plan" means the national contingency plan published under section 311(c) of the Federal Water Pollution Control Act or revised pursuant to section 105 of this Act; and (32) "liable" or "liability" under this title shall be construed to be the standard of liability which obtains under section 311 of the Federal Water Pollution Control Act. REPORTABLE QUANTITIES AND ADDITIONAL DESIGNATIONS Regulations. 42 USC 9602. 33 USC 1321. gEc. 102. (a) The Administrator shall promulgate and revise as may jje appropriate, regulations designating as hazardous substances, in addition to those referred to in section 101(14) of this title, such elements, compounds, mixtures, solutions, and substances which, when released into the environment may present substantial danger to the public health or welfare or the environment, and shall promulgate regulations establishing that quantity of any hazardous substance the release of which shall be reported pursuant to section 103 of this title. The Administrator may determine that one single quantity shall be the reportable quantity for any hazardous substance, regardless of the medium into which the hazardous substance is released. (b) Unless and until superseded by regulations establishing a reportable quantity under subsection (a) of this section for any hazardous substance as defined in section 101(14) of this title, (1) a quantity of one pound, or (2) for those hazardous substances for which reportable quantities have been established pursuant to section 311(b)(4) of the Federal Water Pollution Control Act, such reportable quantity, shall be deemed that quantity, the release of which requires notification pursuant to section 103 (a) or (b) of this title. NOTICES, PENALTIES 42 USC 9603. 33 USC 1251 note 16 use 1801 note SEC. 103. (a) Any person in charge of a vessel or an offshore or an onshore facility shall, as soon as he has knowledge of any release (other than a federally permitted release) of a hazardous substance from such vessel or facility in quantities equal to or greater than those determined pursuant to section 102 of this title, immediately notify the National Response Center established under the Clean Water Act of such release. The National Response Center shall convey the notification expeditiously to all appropriate Government agencies, including the Governor of any affected State. (b) Any person— (1) in charge of a vessel from which a hazardous substance is released, other than a federally permitted release, into or upon the navigable waters of the United States, adjoining shorelines, or into or upon the waters of the contiguous zone, or (2) in charge of a vessel from which a hazardous substance is released, other than a federally permitted release, which may affect natural resources belonging to, appertaining to, or under the exclusive management authority of the United States (including resources under the Fishery Conservation and Management Act of 1976), and who is otherwise subject to the jurisdiction of the United States at the time of the release, or �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2773 (3) in charge of a facility from which a hazardous substance is released, other than a federally permitted release, in a quantity equal to or greater than that determined pursuant to section 102 of this title who fails to notify immediately the appropriate agency of the United States Government as soon as he has knowledge of such release shall, upon conviction, be fined not more than $10,000 or imprisoned for not more than one year, or both. Notification received pursuant to this paragraph or information obtained by the exploitation of such notification shall not be used against any such person in any criminal case, except a prosecution for perjury or for giving a false statement. (c) Within one hundred and eighty days after the enactment of this Act, any person who owns or operates or who at the time of disposal owned or operated, or who accepted hazardous substances for transport and selected, a facility at which hazardous substances (as defined in section 101(14)(C) of this title) are or have been stored, treated, or disposed of shall, unless such facility has a permit issued under, or has been accorded interim status under, subtitle C of the Solid Waste Disposal Act, notify the Administrator of the Environmental Protec- 42 use 6921 tion Agency of the existence of such facility, specifying the amount and type of any hazardous substance to be found there, and any known, suspected, or likely releases of such substances from such facility. The Administrator may prescribe in greater detail the manner and form of the notice and the information included. The Administrator shall notify the affected State agency, or any department designated by the Governor to receive such notice, of the existence of such facility. Any person who knowingly fails to notify the Administrator of the existence of any such facility shall, upon conviction, be fined not more than $10,000, or imprisoned for not more than one year, or both. In addition, any such person who' knowingly fails to provide the notice required by this subsection shall not be entitled to any limitation of liability or to any defenses to liability set out in section 107 of this Act: Provided, however, That notification under this subsection is not required for any facility which would be reportable hereunder solely as a result of any stoppage in transit which is temporary, incidental to the transportation movement, or at the ordinary operating convenience of a common or contract carrier, and such stoppage shall be considered as a continuity of movement and not as the storage of a hazardous substance. Notification received pursuant to this subsection or information obtained by the exploitation of such notification shall not be used against any such person in any criminal case, except a prosecution for perjury or for giving a false statement. (d)(l) The Administrator of the Environmental Protection Agency Rules and is authorized to promulgate rules and regulations specifying, with regulations. respect to— (A) the location, title, or condition of a facility, and (B) the identity, characteristics, quantity, origin, or condition (including contamerization and previous treatment) of any hazardous substances contained or deposited in a facility; the records which shall be retained by any person required to provide the notification of a facility set out in subsection (c) of this section. Such specification shall be in accordance with the provisions of this subsection. (2) Beginning with the date of enactment of this Act, for fifty years thereafter or for fifty years after the date of establishment of a record (whichever is later)* or at any such earlier time as a waiver if obtained under paragraph (3) of this subsection, it shall be unlawful for any �94 STAT. 2774 Rules and regulations. 7 USC 136 note. PUBLIC LAW 96-510-DEC. 11, 1980 such person knowingly to destroy, mutilate, erase, dispose of, conceal, or otherwise render unavailable or unreadable or falsify any records identified in paragraph (1) of this subsection. Any person who violates this paragraph shall, upon conviction, be fined not more than- $20,000, or imprisoned for not more than one year, or both. (3) At any time prior to the date which occurs fifty years after the date of enactment of this Act, any person identified under paragraph (1) of this subsection may apply to the Administrator of the Environmental Protection Agency for a waiver of the provisions of the first sentence of paragraph (2) of this, subsection. The Administrator is authorized to grant such waiver if, in his discretion, such waiver would not unreasonably interfere with the attainment of the purposes and provisions of this Act. The Administrator shall promulgate rules and regulations regarding such a waiver so as to inform parties of the proper application procedure and conditions for approval of such a waiver. (4) Notwithstanding the provisions of this subsection, the Administrator of the Environmental Protection Agency may in his discretion require any such person to retain any record identified pursuant to paragraph (1) of this subsection for such a tune period in excess of the period specified in paragraph (2) of this subsection as the Administrator determines to be necessary to protect the public health or welfare. (e) This section shall not apply to the application of a pesticide product registered under the Federal Insecticide, Fungicide, and Rodenticide Act or to the handling and storage of such a pesticide product by an agricultural producer. (f) No notification shall be required under subsection (a) or (b) of this section for any release of a hazardous substance— (1) which is required to be reported (or specifically exempted from a requirement for reporting) under subtitle C of the Solid Waste Disposal Act or regulations thereunder and which has been reported to the National Response Center, or (2) which is a continuous release, stable in quantity and rate, and is— (A) from a facility for which notification has been given under subsection (c) of this section, or (B) a release of which notification has been given under subsections (a) and (b) of this section for a period sufficient to establish the continuity, quantity, and regularity of such release: Provided, That notification in accordance with subsections (a) and (b) of this paragraph shall be given for releases subject to this paragraph annually, or at such time as there is any statistically significant increase in the quantity of any hazardous substance or constituent thereof released, above that previously reported or occurring. RESPONSE AUTHORITIES 42 USC 9604. 104. (aXD Whenever (A) any hazardous substance is released or there is a substantial threat of such a release into the environment, or (B) there is a release or substantial threat of release into the environment of any pollutant or contaminant which may present an imminent and substantial danger to the public health or welfare, the President is authorized to act, consistent with the national contingency plan, to remove or arrange for the removal of, and provide for remedial action relating to such hazardous substance, pollutant, or contaminant at any time (including its removal from any contami- �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2775 nated natural resource), or take any other response measure consistent with the national contingency plan which the President deems necessary to protect the public health or welfare or the environment, unless the President determines that such removal and remedial action will be done properly by the owner or operator of the vessel or facility from which the release or threat of release emanates, or by any other responsible party. (2) For the purposes of this section, "pollutant or contaminant" "Pollutant or shall include, but not be limited to, any element, substance, com- contaminant. pound, or mixture, including disease-causing agents, which after release into the environment and upon exposure, ingestion, inhalation, or assimilation into any organism, either directly from the environment or indirectly by ingestion through food chains, will or may reasonably be anticipated to cause death, disease, behavioral abnormalities, cancer, genetic mutation, physiological malfunctions (including malfunctions in reproduction) or physical deformations, in such organisms or their offspring. The term does not include petroleum, including crude oil and any fraction thereof which is not otherwise specifically listed or designated as hazardous substances under section 101(14) (A) through (F) of this title, nor does it include natural gas, liquefied natural gas,' or synthetic gas of pipeline quality (or mixtures of natural gas and such synthetic gas). (b) Whenever the President is authorized to act pursuant to subsection (a) of this section, or whenever the President Has reason to believe that a release has occurred or is about to occur, or that illness, disease, or complaints thereof may be attributable to exposure to a hazardous substance, pollutant, or contaminant and that a release may have occurred or be occurring, he may undertake such investigations, monitoring, surveys, testing, and other information gathering as he may deem necessary or appropriate to identify the existence and extent of the release or threat thereof, the source and nature of the hazardous substances, pollutants or contaminants involved, and the extent of danger to the public health or welfare or to the environment. In addition, the President may undertake such planning, legal, fiscal, economic, engineering, architectural, and other studies or investigations as he may deem necessary or appropriate to plan and direct response actions, to recover the costs thereof, and to enforce the provisions of this Act. (cXD Unless (A) the President finds that (i) continued response actions are immediately required to prevent, limit, or mitigate an emergency, (ii) there is an immediate risk to public health or welfare or the environment, and (iii) such assistance will not otherwise be provided on a timely basis, or (B) the President has determined the appropriate remedial actions pursuant to paragraph (2) of this subsection and the State or States in which the source of the release is located have complied with the requirements of paragraph (3) of this subsection, obligations from the Fund, other than those authorized by subsection (b) of this section, shall not continue after $1,000,000 has been obligated for response actions or six months has elapsed from the date of initial response to a release or threatened release of hazardous substances. (2) The President shall consult with the affected State or States before determining any appropriate remedial action to be taken pursuant to the authority granted under subsection (a) of this section. (3) The President shall not provide any remedial actions pursuant to this section unless the State in which the release occurs first enters into a contract or cooperative agreement with the President providing assurances deemed adequate by the President that (A) the State 3tt-861 0 - 8 1 - 2 �94 STAT. 2776 42 use 6921. Post, p. 2796. PUBLIC LAW 96-510—DEC. 11, 1980 will assure all future maintenance of the removal and remedial actions provided for the expected life of such actions as determined by the President; (B) the State will assure the availability of a hazardous waste disposal facility acceptable to the President and in compliance with the requirements of subtitle C of the Solid Waste Disposal Act for any necessary offsite storage, destruction, treatment, or secure disposition of the hazardous substances; and (C) the State will pay or assure payment of (i) 10 per centum of the costs of the remedial action, including all future maintenance, or (ii) at least 50 per centum or such greater amount as the President may determine appropriate, taking into account the degree of responsibility of the State or political subdivision, of any sums expended in response to a release at a facility that was owned at the time of any disposal of hazardous substances therein by the State or a political subdivision thereof. The President shall grant the State a credit against the share of the costs for which it is responsible under this paragraph for any documented direct out-of-pocket non-Federal funds expended or obligated by the State or a political subdivision thereof after January 1, 1978, and before the date of enactment of this Act for cost-eligible response actions and claims for damages compensable under section 111 of this title relating to the specific release in question: Provided, however, That in no event shall the amount of the credit granted exceed the total response costs relating to the release. (4) The President shall select appropriate remedial actions determined to be necessary to carry out this section which are to the extent practicable in accordance with the national contingency plan and which provide for that cost-effective response which provides a balance between the need for protection of public health and welfare and the environment at the facility under consideration, and the availability of amounts from the Fund established under title II of this Act to respond to other sites which present or may present a threat to public health or welfare or the environment, taking into consideration the need for immediate action. (dXl) Where the President determines that a State or political subdivision thereof has the capability to carry out any or all of the actions authorized in this section, the President may, in his discretion, enter into a contract or cooperative agreement with such State or political subdivision to take such actions in accordance with criteria and priorities established pursuant to sectipn 105(8) of this title and to be reimbursed for the reasonable response costs thereof from the Fund. Any contract made hereunder shall be subject to the cost-sharingnroyisions of subsection (c) of this section. (2) If the President enters into a cost-sharing agreement pursuant to subsection (c) of this section or a contract or cooperative agreement pursuant to this subsection, and the State or political subdivision thereof fails to comply with any requirements of the contract, the President may, after providing sixty days notice, seek in the appropriate Federal district court to enforce the contract or to recover any funds advanced or any costs incurred because of the breach of the contract by the State or political subdivision. (3) Where a State or a political subdivision thereof is acting in behalf of the President, the President is authorized to provide technical and legal assistance in the administration and enforcement of any contract or subcontract in connection with response actions assisted under this title, and to intervene in any civil action involving the enforcement of such contract or subcontract. (4) Where two or more noncontiguous facilities are reasonably related on the basis of geography, or on the basis of the threat, or �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2777 potential threat to the public health or welfare or the environment, the President may, in his discretion, treat these related facilities as one for purposes of this section. (eXD For purposes of assisting in determining the need for response to a release under this title or enforcing the provisions of this title, any person who stores, treats, or disposes of, or, where necessary to ascertain facts not available at the facility where such hazardous substances are located, who generates, transports, or otherwise handles or has handled, hazardous substances shall, upon request of any officer, employee, or representative of the President, duly designated by the President, or upon request of any duly designated officer, employee, or representative of a State, where appropriate, furnish information relating to such substances and permit such person at all reasonable times to have access to, and to copy all records relating to such substances. For the purposes specified in the preceding sentence, such officers, employees, or representatives are authorized— (A) to enter at reasonable times any establishment or other place where such hazardous substances are or have been generated, stored, treated, or disposed of, or transported from; (B) to inspect and obtain samples from any person of any such substance and samples of any containers or labeling for such substances. Each such inspection shall be commenced and completed with reasonable promptness. If the officer, employee, or representative obtains any samples, prior to leaving the premises, he shall give to the owner, operator, or person in charge a receipt describing the sample obtained and if requested a portion of each such sample equal in volume of weight to the portion retained. If any analysis is made of such samples, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or person in charge. (2XA) Any records, reports, or information obtained from any person under this section (including records, reports, or information obtained by representatives of the President) shall be available to the public, except that upon a showing satisfactory to the President (or the State, as the case may be) by any person that records, reports, or information, or particular part thereof (other than health or safety effects data), to which the President (or the State, as the case may be) or any officer, employee, or representative has access under this section if made public would divulge information entitled to protection under section 1905 of title 18 of the United States Code, such information or particular portion thereof shall be considered confidential in accordance with the purposes of that section, except that such record, report, document or information may be disclosed to other officers, employees, or authorized representatives of the United States concerned with carrying out this Act, or when relevant in any proceeding under this Act. (B) Any person not subject to the provisions of section 1905 of title 18 of the united States Code who knowingly and willfully divulges or discloses any information entitled to protection under this subsection shall, upon conviction, be subject to a fine of not more than $5,000 or to imprisonment not to exceed one year, or both. (C) In submitting data under this Act, a person required to provide such data may (i) designate the data which such person believes is entitled to protection under this subsection and (ii) submit such designated data separately from other data submitted under this Act. A designation under this paragraph shall be made in writing and in such manner as the President may prescribe by regulation. �94 STAT. 2778 PUBLIC LAW 96-510-DEC. 11, 1980 (D) Notwithstanding any limitation contained in this section or any other provision of law, all information reported to or otherwise obtained by the President (or any representative of the President) under this Act shall be made available, upon written request of any duly authorized committee of the Congress, to such committee. (f) In awarding contracts to any person engaged in response actions, the President or the State, in any case where it is awarding contracts pursuant to a contract entered into under subsection (d) of this section, shall require compliance with Federal health and safety Post, p. 2805. standards established under section 301(0 of this Act by contractors and subcontractors as a condition of such contracts. (gXD All laborers and mechanics employed by contractors or subcontractors in the performance of construction, repair, or alteration work funded in whole or in part under this section shall be paid wages at rates not less than those prevailing on projects of a character similar in the locality as determined by the Secretary of 40 USC 276a Labor in accordance with the Davis-Bacon Act. The President shall note. not approve any such funding without first obtaining adequate assurance that required labor standards will be maintained upon the construction work. (2) The Secretary of Labor shall have, with respect to the labor standards specified in paragraph (1), the authority and functions set forth in Reorganization Plan Numbered 14 of 1950 (15 F.R. 3176; 64 5 USC app. Stat. 1267) and section 276c of title 40 of the United States Code. (h) Notwithstanding any other provision of law, subject to the provisions of section 111 of this Act, the President may authorize the use of such emergency procurement powers as he deems necessary to effect the purpose of this Act. Upon determination that such procedures are necessary, the President shall promulgate regulations prescribing the circumstances under which such authority shall be used and the procedures governing the use of such authority. Agency for Toxic (i) There is hereby established within the Public Health Service an Substances and agency, to be known as the Agency for Toxic Substances and Disease Disease Registry. Registry, which shall report directly to the Surgeon General of the Establishment. United States. The Administrator of said Agency shall, with the cooperation of the Administrator of the Environmental Protection Agency, the Commissioner of the Food and Drug Administration, the Directors of the National Institute of Medicine, National Institute of Environmental Health Sciences, National Institute of Occupational Safety and Health, Centers for Disease Control, the Administrator of the Occupational Safety and Health Administration, and the Administrator of the Social Security Administration, effectuate and implement the health related authorities of this Act. In addition, said Administrator shall— (1) in cooperation with the States, establish and maintain a national registry of serious diseases and illnesses and a national registry of persons exposed to toxic substances; (2) establish and maintain inventory of literature, research, and studies on the health effects of toxic substances; (3) in cooperation with the States, and other agencies of the Federal Government, establish and maintain a complete listing of areas closed to the public or otherwise restricted in use because of toxic substance contamination; (4) in cases of public health emergencies caused or believed to be caused by exposure to toxic substances, provide medical care and testing to exposed individuals, including but not limited to tissue sampling, chromosomal testing, epidemiological studies, �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2779 or any other assistance appropriate under the circumstances; and (5) either independently or as part of other health status survey, conduct periodic survey and screening programs to determine relationships between exposure to toxic substances and illness. In cases of public health emergencies, exposed persons shall be eligible for admission to hospitals and other facilities and services operated or provided by the Public Health Service. NATIONAL CONTINGENCY PtAN SEC. 105. Within one hundred and eighty days after the enactment 42 USC 9605. of this Act, the President shall, after notice and opportunity for public comments, revise and republish the national contingency plan for the removal of oil and hazardous substances, originally prepared and published pursuant to section 311 of the Federal Water Pollution 33 usc 1321 Control Act, to reflect and effectuate the responsibilities and powers created by this Act, in addition to those matters specified in section 311(cJ(2). Such revision shall include a section of the plan to be known as the national hazardous substance response plan which shall establish procedures and standards for responding to releases of hazardous substances, pollutants, and contaminants, which shall include p.t a minimum: (1) methods for discovering and investigating facilities at which hazardous substances have been disposed of or otherwise come to be located; (2) methods for evaluating, including analyses of relative cost, and remedying any releases or threats of releases from facilities which pose substantial danger to the public health or the environment; (3) methods and criteria for determining the appropriate extent of removal, remedy, and other measures authorized by this Act; (4) appropriate roles and responsibilities for the Federal, State, and local governments and for interstate and nongovernmental entities in effectuating the plan; (5) provision for identification, procurement, maintenance, and storage of response equipment and supplies; (6) a method for and assignment of responsibility for reporting the existence of such facilities which may be located on federally owned or controlled properties and any releases of hazardous substances from such facilities; (7) means of assuring that remedial action measures are costeffective over the period of potential exposure to the hazardous substances or contaminated materials; (8XA) criteria for determining priorities among releases or threatened releases throughput the United States for the purpose of taking remedial action and, to the extent practicable taking into account the potential urgency of such action, for the purpose of taking removal action. Criteria and priorities under this paragraph shall be based upon relative risk or danger to public health or welfare or the environment, in the judgment of the President, taking into account to the extent possible the population at risk, the hazard potential of the hazardous substances at such facilities, the potential for contamination of drinking water supplies, the potential for direct human contact, the potential for destruction of sensitive ecosystems, State pre- �94 STAT. 2780 33 USC 1321. Revision and Republication. PUBLIC LAW 96-510-DEC. 11,1980 paredness to assume State costs and responsibilities, and other appropriate factors; (B) based upon the criteria set forth in subparagraph (A) of this paragraph, the President shall list as part of the plan national priorities among the known releases or threatened releases throughout the United States and shall revise the list no less often than annually. Within one year after the date of enactment of this Act, and annually thereafter, each State shall establish and submit for consideration by the President priorities for remedial action among known releases and potential releases in that State based upon the criteria set forth in subparagraph (A) of this paragraph. In assembling or revising the national list, the President shall consider any priorities established by the States. To the extent practicable, at least four hundred of the highest priority facilities shall be designated individually and shall be referred to as the "top priority among known response targets", and, to the extent practicable, shall include among the one hundred highest priority facilities at least one such facility from each State which shall be the facility designated by the State as presenting the greatest danger to public health or welfare or the environment among the known facilities in such State. Other priority facilities or incidents may be listed singly or grouped for response priority purposes; and (9) specified roles for private organizations and entities in preparation for response and in responding to releases of hazardous substances, including identification of appropriate qualifications and capacity therefor. The plan shall specify procedures, techniques, materials, equipment, and methods to be employed in identifying, removing, or remedying releases of hazardous substances comparable to those required under section 311(cX2) (F) and (G) and (JXD of the Federal Water Pollution Control Act. Following publication of the revised national contingency plan, the response to and actions to minimize damage from hazardous substances releases shall, to the greatest extent possible, be in accordance with the provisions of the plan. The President may, from time to time, revise and republish the national contingency plan. ABATEMENT ACTION 42 USC 9606. Notice. SEC. 106. (a) In addition to any other action taken by a State or local government, when the President determines that there may be an imminent and substantial endangerment to the public health or welfare or the environment because of an actual or threatened release of a hazardous substance from a facility, he may require the Attorney General of the United States to secure such relief as may be necessary to abate such danger or threat, and the district court of the United States in the district in which the threat occurs shall have jurisdiction to grant such relief as the public interest and the equities of the case may require. The President may also, after notice to the affected State, take other action under this section including, but not limited to, issuing such orders as may be necessary to protect public health and welfare and the environment. (b) Any person who willfully violates, or fails or refuses to comply with, any order of the President under subsection (a) may, in an action brought in the appropriate United States district court to enforce such order, be fined not more than $5,000 for each day in which such violation occurs or such failure to comply continues. �PUBLIC LAW 96-510—DEC. 11,1980 94 STAT. 2781 (c) Within one hundred and eighty days after enactment of this Act, the Administrator of the Environmental Protection Agency shall, after consultation with the Attorney General, establish and publish guidelines for using the imminent hazard, enforcement, and emergency response authorities of this section and other existing statutes administered by the Administrator of the Environmental Protection Agency to effectuate the responsibilities and powers created by this Act. Such guidelines shall to the extent practicable be consistent with the national hazardous substance response plan, and shall include, at a minimum, the assignment of responsibility for coordinating response actions with the issuance of administrative orders, enforcement of standards and permits, the gathering of information, and other imminent hazard and emergency powers authorized by (1) sections 311(cX2), 308,309, and 504(a) of the Federal Water Pollution Control Act, (2) sections 3007,3008,3013, and 7003 of the Solid Waste Disposal Act, (3) sections 1445 and 1431 of the Safe Drinking Water Act, (4) sections 113,114, and 303 of the Clean Air Act, and (5) section 7 of the Toxic Substances Control Act. LIABILITY SEC. 107, (a) Notwithstanding any other provision or rule of law, and subject only to the defenses set forth in subsection (b) of this section— (1) the owner and operator of a vessel (otherwise subject to the jurisdiction of the United States) or a facility, (2) any person who at the time of disposal of any hazardous substance owned or operated any facility at which such hazardous substances were disposed of, (3) any person who by contract, agreement, or otherwise arranged for disposal or treatment, or arranged with a transporter for transport for disposal or treatment, of hazardous substances owned or possessed by such person, by any other party or entity, at any facility owned or operated by another party or entity and containing such hazardous substances, and (4) any person who accepts or accepted any hazardous substances for transport to disposal or treatment facilities or sites selected by such person, from which there is a release, or a threatened release which causes the incurrence of response costs, of a hazardous substance, shall be liable for— (A) all costs of removal or remedial action incurred by the United States Government or a State not inconsistent with the national contingency plan; (B) any other necessary costs of response incurred by any other person consistent with the national contingency plan; and (C) damages for injury to, destruction of, or loss of natural resources, including the reasonable costs of assessing such injury, destruction, or loss resulting from such a release. (b) There shall be no liability under subsection (a) of this section for a person otherwise liable who can establish by a preponderance of the evidence that the release or threat of release of a hazardous substance and the damages resulting therefrom were caused solely byCD an act of God; (2) an act of war; (3) an act or omission of a third party other than an employee or agent of the defendant, or than one whose act or omission occurs in connection with a contractual relationship, existing Guidelines. 33 USC 1321, 1318, 1319, 1364. 42 USC 6927, 6928; Ante, p. 2344; 42 USC 6973. 42 USC 300J-4, 300i. 42 USC 7413, 7414, 7603. 16 USC 2606. 42 USC 9607. �94 STAT. 2782 49 use 2001 note PUBLIC LAW 96-510—DEC. 11,1980 directly or indirectly, with the defendant (except where the sole contractual arrangement arises from a published tariff and acceptance for carriage by a common carrier by rail), if the defendant establishes by a preponderance of the evidence that (a) he exercised due care with respect to the hazardous substance concerned, taking into consideration the characteristics of such hazardous substance, in light of all relevant facts and circumstances, and (b) he took precautions against foreseeable acts or omissions of any such third party and the consequences that could foreseeably result from such acts or omissions; or (4) any combination of the foregoing paragraphs. (cXl) Except as provided in paragraph (2) of this subsection, the liability under this section of an owner or operator or other responsible person for each release of a hazardous substance or incident involving release of a hazardous substance shall not exceed— (A) for any vessel which carries any hazardous substance as cargo or residue, $300 per gross ton, or $5,000,000, whichever is greater; (B) for any other vessel, $300 per gross ton, or $500,000, whichever is greater; (C) for any motor vehicle, aircraft, pipeline (as defined in the Hazardous Liquid Pipeline Safety Act of 1979), or rolling stock, $50,000,000 or such lesser amount as the President shall establish by regulation, but in no event less than $5,000,000 (or, for releases of hazardous substances as defined in section 101(14XA) of this title into the navigable waters, $8,000,000). Such regulations shall take into account the size, type, location, storage, and handling capacity and other matters relating to the likelihood of release m each such class and to the economic impact of such limits on each such class; or (D) for any facility other than those specified in subparagraph (C) of this paragraph, the total of all costs of response plus $50,000,000 for any damages under this title. (2) Notwithstanding the limitations in paragraph (1) of this subsection, the liability of an owner or operator or other responsible person under this section shall be the full and total costs of response and damages, if (AXi) the release or threat of release of a hazardous substance was the result of willful misconduct or willful negligence within the privity or knowledge of such person, or (ii) the primary cause of the release was a violation (within the privity or knowledge of such person) of applicable safety, construction, or operating standards or regulations; or (B) such person fails or refuses to provide all reasonable cooperation and assistance requested by a responsible public official in connection with response activities under the national contingency plan with respect to regulated carriers subject to the provisions of title 49 of the United States Code or vessels subject to the provisions of title 33 or 46 of the United States Code, subparagraph (AXii) of this paragraph shall be deemed to refer to Federal standards or regulations. (3) If any person who is liable for a release or threat of release of a hazardous substance fails without sufficient cause to properly provide removal or remedial action upon order of the President pursuant to section 104 or 106 of this Act, such person may be liable to the United States for punitive damages in an amount at least equal to, and not more than three times, the amount of any costs incurred by the Fund as a result of such failure to take proper action. The President is authorized to commence a civil action against any such person to recover the punitive damages, which shall be in addition to �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2783 any costs recovered from such person pursuant to section 112(c) of this Act. Any moneys received by the United States pursuant to this subsection shall be deposited in the Fund. (d) No person shall be liable under this title for damages as a result of actions taken or omitted in the course of rendering care, assistance, or advice in accordance with the national contingency plan or at the direction of an onscene coordinator appointed under such plan, with respect to an incident creating a danger to public health or welfare or the environment as a result of any release of a hazardous substance or the threat thereof. This subsection shall not preclude liability for damages as the result of gross negligence or intentional misconduct on the part of such person. For the purposes of the preceding sentence, reckless, willful, or wanton misconduct shall constitute gross negligence. (eXD No indemnification, hold harmless, or similar agreement or conveyance shall be effective to transfer from the owner or operator of any vessel or facility or from any person who may be liable for a release or threat of release under this section, to any other person the liability imposed under this section. Nothing in this subsection shall bar any agreement to insure, hold harmless, or indemnify a party to such agreement for any liability under this section. (2) Nothing in this title, including the provisions of paragraph (1) of this subsection, shall bar a cause of action that an owner or operator or any other person subject to liability under this section, or a guarantor, has or would have, by reason of subrogation or otherwise against any person. (f) In the case of an injury to, destruction of, or loss of natural resources under subparagraph (C) of subsection (a) liability shall be to the United States Government and to any State for natural resources within the State or belonging to, managed by, controlled by, or appertaining to such State: Provided, however. That no liability to the United States or State shall be imposed under subparagraph (C) of subsection (a), where the party sought to be charged has demonstrated that the damages to natural resources complained of were specifically identified as an irreversible and irretrievable commitment of natural resources in an environmental impact statement, or other comparable environment analysis, and the decision to grant a permit or license authorizes such commitment of natural resources, and the facility or project was otherwise operating within the terms of its permit or license. The President, or the authorized representative of any State,' shall act on behalf of the public as trustee of such natural resources to recover for such damages. Sums recovered shall be available for use to restore, rehabilitate, or acquire the equivalent of such natural resources by the appropriate agencies of the Federal Government or the State government, but the measure of such damages shall not be limited by the sums which can be used to restore or replace such resources. There shall be no recovery under the authority of subparagraph (C) of subsection (a) where such damages and the release of a hazardous substance from which such damages resulted have occurred wholly before the enactment of this Act. (g) Each department, agency, or instrumentality of the executive, legislative, and judicial branches of the Federal Government shall be subject to, and comply with, this Act in the same manner and to the same extent, both procedurally and substantively, as any nongovernmental entity, including liability under this section. (h) The owner or operator of a vessel shall be liable in accordance with this section and as provided under section 114 of this Act �94 STAT. 2784 PUBLIC LAW 96-510—DEC. 11, 1980 notwithstanding any provision of the Act of March 3,1851 (46 U.S.C. 183ff). (1) No person (including the United States or any State) may recover under the authority of this section for any response costs or damages resulting from the application of a pesticide product regis7 use 136 note, tered under the Federal Insecticide, Fungicide, and Rodenticide Act Nothing in this paragraph shall affect or modify in any way the obligations or liability of any person under any other provision of State or Federal law, including common law, for damages, injury, or loss resulting from a release of any hazardous substance or for removal or remedial action or the costs of removal or remedial action of such hazardous substance. 0') Recovery by any person (including the United States or any State) for response costs or damages resulting from a federally permitted release shall be pursuant to existing law in lieu of this section. Nothing in this paragraph shall affect or modify in any way the obligations or liability of any person under any other provision of State or Federal law, including common law, for damages, injury, or loss resulting from a release of any hazardous substance or for removal or remedial action or the costs of removal or remedial action of such hazardous substance. In addition, costs of response incurred by the Federal Government in connection with a discharge specified in section 101(10) (B) or (C) shall be recoverable in an action brought 33 use 1319. under section 309flb) of the Clean Water Act. (kXD The liability established by this section or any other law for the owner or operator of a hazardous waste disposal facility which has received a permit under subtitle C of the Solid Waste Disposal Act, shall be transferred to and assumed by the Post-closure Liability Post, p. 2804. Fund established by section 232 of this Act when— (A) such facility and the owner and operator thereof has complied with the requirements of subtitle C of the Solid Waste Disposal Act and regulations issued thereunder, which may affect the performance of such facility after closure; and (B) such facility has been closed in accordance with such regulations and the conditions of such permit, and such facility and the surrounding area have been monitored as required by such regulations and permit conditions for a period not to exceed five years after closure to demonstrate that there is no substantial likelihood that any migration offsite or release from confinement of any hazardous substance or other risk to public health or welfare will occur. (2) Such transfer of liability shall be effective ninety days after the owner or operator of such facility notifies the Administrator of the Environmental Protection Agency (and the State where it has an authorized program under section 3006(b) of the Solid Waste Disposal 42 use 6926. Act) that the conditions imposed by this subsection have been satisfied. If within such ninety-day period the Administrator of the Environmental Protection Agency or such State determines that any such facility has not complied with all the conditions imposed by this subsection or that insufficient information has been provided to demonstrate such compliance, the Administrator or such State shall so notify the owner and operator of such facility and the administrator of the Fund established by section 232 of this Act, and the owner and operator of such facility shall continue to be liable with respect to such facility under this section and other law until such time as the Administrator and such State determines that such facility has complied with all conditions imposed by this subsection. A determination by the Administrator or such State that a facility has not �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2785 complied with all conditions imposed by this subsection or that insufficient information has been supplied to demonstrate compliance, shall be a final administrative action for purposes of judicial review. A request for additional information shall state in specific terms the data required. (3) In addition to the assumption of liability of owners and operators under paragraph (1) of this subsection, the Post-closure Liability Fund established by section 232 of this Act may be used to pay costs of monitoring and care and maintenance of a site incurred by other persons after the period of monitoring required by regulations under subtitle C of the Solid Waste Disposal Act for hazardous waste 42 use 6921. disposal facilities meeting the conditions of paragraph (1) of this subsection. (4XA) Not later than one year after the date of enactment of this Act, the Secretary of the Treasury shall conduct a study and shall submit a report thereon to the Congress on the feasibility of establishing or qualifying an optional system of private insurance for postclosure financial responsibility for hazardous waste disposal facilities to which this subsection applies. Such study shall include a specification of adequate and realistic minimum standards to assure that any such privately placed insurance will carry out the purposes of this subsection in a reliable, enforceable, and practical manner. Such a study shall include an examination of the public and private incentives, programs, and actions necessary to make privately placed insurance a practical and effective option to the financing system for the Postclosure Liability Fund provided in title II of this Act. (B) Not later than eighteen months after the date of enactment of this Act and after a public hearing, the President shall by rule determine whether or not it is feasible to establish or qualify an optional system of private insurance for postclosure financial responsibility for hazardous waste disposal facilities to which this subsection applies. If the President; determines the establishment or qualification of such a system would be infeasible, he shall promptly publish an explanation of the reasons for such a determination. If the President determines the establishment or qualification of such a system would be feasible, he shall promptly publish notice of such determination. Not later than six months after an affirmative determination under the preceding sentence and after a public hearing, the President shall by rule promulgate adequate and realistic minimum standards which must be met by any such privately placed insurance, taking into account the purposes of this Act and this subsection. Such rules shall also specify reasonably expeditious procedures by which privately placed insurance plans can qualify as meeting such minimum standards. (C) In the event any privately placed insurance plan qualifies under subparagraph (B), any person enrolled in, and complying with the terms of, such plan shall be excluded from the provisions of paragraphs (1), (2), and (3) of this subsection and exempt from the requirements to pay any tax or fee to the Post-closure Liability Fund under title II of this Act. (D) The President may issue such rules and take such other actions as are necessary to effectuate the purposes of this paragraph. FINANCIAL RESPONSIBILITY SEC. 108. (aXD The owner or operator of each vessel (except a nonself-propelled barge that does no t carry hazardous substances as cargo) over three hundred gross ton s that uses any port or place in the 42 usc 9608 - �94 STAT. 2886 PUBLIC LAW 96-510—DEC. 11, 1980 United States or the navigable waters or any offshore facility, shall establish and maintain, in accordance with regulations promulgated by the President, evidence of financial responsibility of $300 per gross ton (or for a vessel carrying hazardous substances as cargo, or $5,000,000, whichever is greater). Financial responsibility may be established by any one, or any combination, of the following: insurance, guarantee, surety bond, or qualification as a self-insurer. Any bond filed shall be issued by a bonding company authorized to do business in the United States. In cases where an owner or operator owns, operates, or charters more than one vessel subject to this subsection, evidence of financial responsibility need be established only to meet the maximum liability applicable to the largest of such vessels. (2) The Secretary of the Treasury shall withhold or revoke the clearance required by section 4197 of the Revised Statutes of the 46 use 91. United States of any vessel subject to this subsection that does not have certification furnished by the President that the financial responsibility provisions of paragraph (1) of this subsection have been complied with. (3) The Secretary of Transportation, in accordance with regulations issued by him, shall (A) deny entry to any port or place in the United States or navigable waters to, and (B) detain at the port or place in the United States from which it is about to depart for any other port or place in the United States, any vessel subject to this subsection that, upon request, does not produce certification furnished by the President that the financial responsibility provisions of paragraph (1) of this subsection have been complied with. (bXD Beginning not earlier than five years after the date of enactment of this Act, the President shall promulgate requirements (for facilities in addition to those under subtitle C of the Solid Waste 42 use 6921. Disposal Act and other Federal law) that classes of facilities establish and maintain evidence of financial responsibility consistent with the degree and duration of risk associated with the production, transporPubiication in tation, treatment, storage, or disposal of hazardous substances. Not Federal Register jater than tnree years after tne date Of enactment of the Act, the President shall identify those classes for which requirements will be first developed and publish notice of such identification in the Federal Register. Priority in the development of such requirements shall be accorded to those classes of facilities, owners, and operators which the President determines present the highest level of risk of injury. (2) The level of financial responsibility shall be initially established, and, when necessary, adjusted to protect against the level of risk which the President in his discretion believes is appropriate based on the payment experience of the Fund, commercial insurers, courts settlements and judgments, and voluntary claims satisfaction. To the maximum extent practicable, the President shall cooperate with and seek the advice of the commercial insurance industry in developing financial responsibility requirements. (3) Regulations promulgated under this subsection shall incrementally impose financial responsibility requirements over a period of not less than three'and no more than six years after the date of promulgation. Where possible, the level of financial responsibility which the President believes appropriate as a final requirement shall be achieved through incremental, annual increases in the requirements. (4) Where a facility is owned or operated by more than one person, evidence of financial responsibility covering the facility may be �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2887 established and maintained by one of the owners or operators, or, in consolidated form, by or on behalf of two or more owners or operators. When evidence of financial responsibility is established in a consolidated form, the proportional share of each participant shall be shown. The evidence shall be accompanied by a statement authorizing the applicant to act for and in behalf of each participant in submitting and maintaining the evidence of financial responsibility. (5) The requirements for evidence of financial responsibility for motor carriers covered by this Act shall be determined under section 80 of the Motor Carrier Act of 1980, Public Law 96-296. Ante, p. 820. (c) Any claim authorized by section 107 or 111 may be asserted directly against any guarantor providing evidence of financial responsibility as required under this section. In defending such a claim, the guarantor may invoke all rights and defenses which would be available to the owner or operator under this title. The guarantor may also invoke the defense that the incident was caused by the willful misconduct of the owner or operator, but such guarantor may not invoke any other defense that such guarantor might have been entitled to invoke in a proceeding brought by the owner or operator against him. (d) Any guarantor acting in good faith against which claims under this Act are asserted as a guarantor shall be liable under section 107 or section 112(c) of this title only up to the monetary limits of the policy of insurance or indemnity contract such guarantor has undertaken or of the guaranty of other evidence of financial responsibility furnished under section 108 of this Act, and only to the extent that liability is not excluded by restrictive endorsement: Provided, That this subsection shall not alter the liability of any person under section 107 of this Act. PENALTY SEC. 109. Any person who, after notice and an opportunity for a 42 use 9609. hearing, is found to have failed to comply with the requirements of section 108, the regulations issued thereunder, or with any denial or detention order shall be liable to the United States for a civil penalty, not to exceed $10,000 for each day of violation. EMPLOYEE PROTECTION SEC. 110. (a) No person shall fire or in any other way discriminate 12 use 96io. against, or cause to be fired or discriminated against, any employee or any authorized representative of employees by reason of the fact that such employee or representative has provided information to a State or to the Federal Government, filed, Instituted, or caused to be filed or instituted any proceeding under this Act, or has testified or is about to testify in any proceeding resulting from the administration or enforcement of the provisions of this Act. Ob) Any employee or a representative of employees who believes that he has been fired or otherwise discriminated against by any person in violation of subsection (a) of this section may, within thirty days after such alleged violation occurs, apply to the Secretary of Labor for a review of such firing or alleged discrimination. A copy of the application shall be sent to such person, who shall be the respondent. Upon receipt of such application, the Secretary of Labor shall cause such investigation to be made as he deems appropriate. Such investigation shall provide an opportunity for a public hearing at the request of any party to such review to enable the parties to �94 STAT. 2788 PUBLIC LAW 96-510—DEC. 11,1980 present information relating to such alleged violation. The parties shall be given written notice of the time and place of the hearing at least five days prior to the hearing. Any such hearing shall be of record and shall be subject to section 554 of title 5, United States Code. Upon receiving the report of such investigation, the Secretary of Labor shall make findings of fact. If he finds that such violation did occur, he shall issue a decision, incorporating an order therein and his findings, requiring the party committing such violation to take such affirmative action to abate the violation as the Secretary of Labor deems appropriate, including, but not limited to, the rehiring or reinstatement of the employee or representative of employees to his former position with compensation. If he finds that there was no such violation, he shall issue an order denying the application. Such order issued by the Secretary of Labor under this subparagraph shall be subject to judicial review in the same manner as orders and decisions are subject to judicial review under this Act. (c) Whenever an order is issued under this section to abate such violation, at the request of the applicant a sum equal to the aggregate amount of all costs and expenses (including the attorney s fees) determined by the Secretary of Labor to have been reasonably incurred by the applicant for, or in connection with, the institution and prosecution of such proceedings, shall be assessed against the person committing such violation. (d) This section shall have no application to any employee who acting without discretion from his employer (or his agent) deliberately violates any requirement of this Act. (e) The President shall conduct continuing evaluations of potential loss of shifts of employment which may result from the administration or enforcement of the provisions of this Act, including, where appropriate, investigating threatened plant closures or reductions in employment allegedly resulting from such administration or enforcement. Any employee who is discharged, or laid off, threatened with discharge or layoff, or otherwise discriminated against by an/person because of the alleged results of such administration or enforcement, or any representative of such employee, may request the President to conduct a full investigation of the matter and, at the request of any party, shall hold public hearings, require the parties, including the employer involved, to present information relating to the actual or potential effect of such administration or enforcement on employment and any alleged discharge, layoff, or other discrimination, and the detailed reasons or justification therefore. Any such hearing shall be of record and shall be subject to section 554 of title 5, United States Code. Upon receiving the report of such investigation, the President shall make findings of fact as to the effect of such administration or enforcement on employment and on the alleged discharge, layoff, or discrimination and shall make such recommendations as he deems appropriate. Such report, findings, and recommendations shall be available to the public. Nothing in this subsection shall be construed to require or authorize the President or any State to modify or withdraw any action, standard, limitation, or any other requirement of this Act. USES OF FUND 42 use 9611. SEC. 111. (a) The President shall use the money in the Fund for the following purposes: �PUBLIC LAW 96-610—DEC. 11,1980 94 STAT. 2789 (1) payment of governmental response costs incurred pursuant to section 104 of this title, including costs incurred pursuant to the Intervention on the High Seas Act; 33 use 1471 (2) payment of any claim for necessary response costs incurred notel by any other person as a result of carrying out the national contingency plan established under section 311(c) of the Clean Water Act and amended by section 105 of this title: Provided, 33 use 1321. however, That such costs must be approved under said plan and certified by the responsible Federal official; (3) payment of any claim authorized by subsection (b) of this section and finally decided pursuant to section 112 of this title, including those costs set out in subsection 112(cX3) of this title; and (4) payment of costs specified under subsection (c) of this section. The President shall not pay for any administrative costs or expenses out of the Fund unless such costs and expenses are reasonably necessary for and incidental to the implementation of this title. (b) Claims asserted and compensable but unsatisfied under provisions of section 311 of the Clean Water Act, which are modified by section 304 of this Act may be asserted against the Fund under this Post, p. 2809. title; and other claims resulting from a release or threat of release of a hazardous substance from a vessel or a facility may be asserted against the Fund under this title for injury to, or destruction or loss of, natural resources, including cost for damage assessment: Provided, however, That any such claim may be asserted only by the President, as trustee, for natural resources over which the United States has sovereign rights, or natural resources within the territory or the fishery conservation zone of the United States to the extent they are managed or protected by the United States, or by any State for natural resources within the boundary of that State belonging to, managed by, controlled by, or appertaining to the State. (c) Uses of the Fund under subsection (a) of this section include— (1) the costs of assessing both short-term and long-term injury to, destruction of, or loss of any natural resources resulting from a release of a hazardous substance; (2) the costs of Federal or State efforts in the restoration, rehabilitation, or replacement or acquiring the equivalent of any natural resources injured, destroyed, or lost as a result of a release of a hazardous substance; (3) subject to such amounts as are provided in appropriation Acts, the costs of a program to identify, investigate, and take enforcement and abatement action against releases of hazardous substances; (4) the costs of epidemiologic studies, development and maintenance of a registry of persons exposed to hazardous substances to allow long-term health effect studies, and diagnostic services not otherwise available to determine whether persons in populations exposed to hazardous substances in connection with a release or a suspected release are suffering from long-latency diseases; (5) subject to such amounts as are provided in appropriation Acts, the costs of providing equipment and similar overhead, related to the purposes of this Act and section 311 of the Clean Water Act, and needed to supplement equipment and services available through contractors or other non-Federal entities, and of establishing and maintaining damage assessment capability, for any Federal agency involved in strike forces, emergency task �94 STAT. 2790 PUBLIC LAW 96-510—DEC. 11,1980 forces, or other response teams under the national contingency •plan; and (6) subject to such amounts as are provided in appropriation Acts, the costs of a program to protect the health and safety of employees involved in response to hazardous substance releases. Such program shall be developed jointly by the Environmental Protection Agency, the Occupational Safety and Health Administration, and the National Institute for Occupational Safety and Health and shall include, but not be limited to, measures for identifying and assessing hazards to which persons engaged in removal, remedy, or other response to hazardous substances may be exposed, methods to protect workers from such hazards, and necessary regulatory and enforcement measures to assure adequate protection of such employees. (dXD No money in the Fund may be used under subsection (c) (1) and (2) of this section, nor for the payment of any claim under subsection (b) of this section, where the injury, destruction, or loss of natural resources and the release of a hazardous substance from which such damages resulted have occurred wholly before the enactment of this Act. (2) No money in the Fund may be used for the payment of any claim under subsection (b) of this section where such expenses are associated with injury or.loss resulting from long-term exposure to ambient concentrations of air pollutants from multiple or diffuse sources. (eXl) Claims against or presented to the Fund shall not be valid or paid in excess of the total money in the Fund at any one time. Such claims become valid only when additional money is collected, appropriated, or otherwise added to the Fund. Should the total claims outstanding at any tune exceed the current balance of the Fund, the President shall pay such claims, to the extent authorized under this section, in full in the order in which, they were finally determined. Regulations. (2) In any fiscal year, 85 percent of the money credited to the Fund under title II of this Act shall be available only for the purposes specified in paragraphs (1), (2), and (4) of subsection (a) of this section. (3) No money in the Fund shall be available for remedial action, other than actions specified in subsection (c) of this section, with respect to federally owned facilities. (4) Paragraphs (1) and (4) of subsection (a) of this section shall in the aggregate oe subject to such amounts as are provided in appropriation Acts. (f) The President is authorized to promulgate regulations designating one or more Federal officials who may obligate money in the Fund in accordance with this section or portions thereof. The President is also authorized to delegate authority to obligate money in the Fund or to settle claims to officials of a State operating under a contract or cooperative agreement with the Federal Government pursuant to section 104(d) of this title. (g) The President shall provide for the promulgation of rules and regulations with respect to the notice to be provided to potential injured parties by an owner and operator of any vessel, or facility from which a hazardous substance has been released. Such rules and regulations shall consider the scope and form of the notice which would be appropriate to carry out the purposes of this title. Upon promulgation of cuch rules and regulations, the owner and operator of any vessel or facility from which a hazardous substance has been released shall provide notice in accordance with such rules and regulations. With respect to releases from public vessels, the President shall provide such notification as is appropriate to potential �PUBLIC LAW 96-510—DEC. 11,1980 94 STAT. 2791 injured parties. Until the promulgation of such rules and regulations, the owner and operator of any vessel or facility from which a hazardous substance has been released shall provide reasonable notice to potential injured parties by publication in local newspapers serving the affected area. (hXD In accordance with regulations promulgated under section 801(c) of this Act, damages for injury to, destruction of, or loss of natural resources resulting from a release of a hazardous substance, for the purposes of this Act and section 311(0 (4) and (5) of the Federal 83 usc 1321 Water Pollution Control Act, shall be assessed by Federal officials designated by the President under the national contingency plan published under section 105 of the Act, and such officials shall act for the President as trustee under this section and section 311(fX5) of the Federal Water Pollution Control Act. (2) Any determination or assessment of damages for injury to, destruction of, or loss of natural resources for the purposes of this Act and section 311(f> (4) and (5) of the Federal Water Pollution Control Act shall have the force and effect of a rebuttable presumption on behalf of any claimant (including a trustee under section 107 of this Act or a Federal agency) in any judicial or adjudicatory administrative proceeding under this Act or section 311 of the Federal Water Pollution Control Act. (i) Except in a situation requiring action to avoid an irreversible loss of natural resources or to prevent or reduce any continuing danger to natural resources or similar need for emergency action, funds may not be used under this Act for the restoration, rehabilitation, or replacement or acquisition of the equivalent of any natural resources until a plan for the use of such funds for such purposes has been developed and adopted by affected Federal agencies and the Governor or Governors of any State having sustained damage to natural resources within its borders, belonging to, managed by or appertaining to such State, after adequate public notice and opportunity for hearing and consideration of all public comment. 0) The President shall use the money in the Post-closure Liability Fund for any of the purposes specified in subsection (a) of this section with respect to a hazardous waste disposal facility for which liability has transferred to such fund under section 107(k) of this Act, and, in addition, for payment of any claim or appropriate request for costs of response, damages, or other compensation for injury or loss under section 107 of this Act or any other State or Federal law, resulting from a release of a hazardous substance from such a facility. (k) The Inspector General of each department or agency to which responsibility to obligate money in the Fund is delegated shall Con ress Report to provide an audit review team to audit all payments, obligations, « reimbursements, or other uses of the Fund, to assure that the Fund is being properly administered and that claims are being appropriately and expeditiously considered. Each such Inspector General shall submit to the Congress an interim report one year after the establishment of the Fund and a final report two years after the establishment of the Fund. Each such Inspector General shall thereafter provide such auditing of the Fund as is appropriate. Each Federal agency shall cooperate with the Inspector General in carrying out this subsection. (1) To the extent that the provisions of this Act permit, a foreign claimant may assert a claim to the same extent that a United States claimant may assert a claim if— �94 STAT. 2792 PUBLIC LAW 96-510—DEC. 11, 1980 (1) the release of a hazardous substance occurred (A) in the navigable waters or (B) in or on the territorial sea or adjacent shoreline of a foreign country of which the claimant is a resident; (2) the claimant is not otherwise compensated for his loss; (3) the hazardous substance was released from a facility or from a vessel located adjacent to or within the navigable waters or was discharged in connection with activities conducted under the Outer Continental Shelf Lands Act, as amended (43 U.8.C. 1331 et seq.) or the Deepwater Port Act of 1974, as amended (33 U.S.C. 1501 et eeq.); and (4) recovery is authorized by a treaty or an executive agreement between the United States and foreign country involved, or if the Secretary of State, in consultation with the Attorney General and other appropriate officials, certifies that such country provides a comparable remedy for United States claimants. CLAIMS PROCEDURE 42 use 9612. SEC. 112. (a) All claims which may be asserted against the Fund pursuant to section 111 of this title shall be presented in the first instance to the owner, operator, or guarantor of the vessel or facility from which a hazardous substance has been released, if known to the claimant, and to any other person known to the claimant who may be liable under section 107 of this title. In any case where the claim has not been satisfied within sixty days of presentation in accordance with this subsection, the claimant may elect to commence an action in court against such owner, operator, guarantor, or other person or to present the claim to the Fund for payment. (bXD The President shall prescribe appropriate forms and procedures for claims filed hereunder, which shall include a provision requiring the claimant to make a sworn verification of the claim to the best of his knowledge. Any person who knowingly gives or causes to be given any false information as a part of any such claim shall, upon conviction, be fined up to $5,000 or imprisoned for not more than one year, or both. (2XA) Upon receipt of any claim, the President shall as soon as practicable inform any known affected parties of the claim and shall attempt to promote and arrange a settlement between the claimant and any person who may be liable. If the claimant and alleged liable party or parties can agree upon a settlement, it shall be final and binding upon the parties thereto, who will be deemed to have waived all recourse against the Fund. (B) Where a liable party is unknown or cannot be determined, the claimant and the President shall attempt to arrange settlement of any claim against the Fund. The President is authorized to award and make payment of such a settlement, subject to such proof and procedures as he may promulgate by regulation. (C) Except as provided in subparagraph (D) of this paragraph, the President shall use the facilities and services of private insurance and claims adjusting organizations or State agencies in implementing this subsection and may contract to pay compensation for those facilities and services. Any contract made under the provisions of this paragraph may be made without regard to the provisions of section 3709 of the Revised Statutes, as amended (41 U.S.C. 5), upon a showing by the President that advertising is not reasonably practicable. When the services of a State agency are used hereunder, no payment may be made on a claim asserted on behalf of that State or �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2793 any of its agencies or subdivisions unless the payment has been approved by the President. (D) To the extent necessitated by extraordinary circumstances, where the services of such private organizations or State agencies are inadequate, the President may use Federal personnel to implement this subsection. (3) If no settlement is reached within forty-five days of filing of a claim through negotiation pursuant to this section, the President may, if he is satisfied that the information developed during the processing of the claim warrants it, make and pay an award of the claim. If the claimant is dissatisfied with the award, he may appeal it in the manner provided for in subparagraph (G) of paragraph (4) of this subsection. If the President declines to make an award, lie shall submit the claim for decision to a member of the Board of Arbitrators established pursuant to paragraph (4). (4XA) Within ninety days of the enactment of this Act, the President shall establish a Board of Arbitrators to implement this subsection. The Board shall consist of as many members as the President may determine will be necessary to implement this subsection expeditiously, and he may increase or decrease the size of the Board at any time in his discretion in order to enable it to respond to the demands of such implementation. Each member of the Board shall be selected through utilization of the procedures of the American Arbitration Association: Provided, however, That no regular employee of the President or any of the Federal departments, administrations, or agencies to whom he delegated responsibilities under this Act shall act as a member of the Board. (B) Hearings conducted hereunder shall be public and shall be held in such place as may be agreed upon by the parties thereto, or, in the absence of such agreement, in such place as the President determines, in his discretion, will be most convenient for the parties thereto. (C) Hearings before a member of the Board shall be informal, and the rules of evidence prevailing in judicial proceedings need not be required. Each member of the Board shall have the power to administer oaths and to subpena the attendance and testimony of witnesses and the production of books, records, and other evidence relative or pertinent to the issues presented to him for decision. Testimony may be taken by interrogatory or deposition. Each person appearing before a member of the Board shall have the right to counseL Subpenas shall be issued and enforced in accordance with procedures in subsection (d) of section 555 of title 5, United States Code, and rules promulgated by the President. If a person fails or refuses to obey a subpena, the President may invoke the aid of the district court of the United States where the person is found, resides, or transacts business in requiring the attendance and testimony of the person and the production by him of books, papers, documents, or any tangible things. (D) In any proceeding before a member of the Board, the claimant shall bear the burden of proving his claim. Should a member of the Board determine that further investigations, monitoring, surveys, testing, or other information gathering would be useful and necessary in deciding the claim, he may request the President in writing to undertake such activities pursuant to section 104(b) of this title. The President shall dispose of such a request in his sole discretion, taking into account various competing demands and the availability of the technical and financial capacity to conduct such studies, monitoring, and investigations. Should the President decide to undertake the �94 STAT. 2794 PUBLIC LAW 96-510—DEC. 11, 1980 requested actions, all time requirements for the processing and deciding of claims hereunder shall be suspended until the President reports the results thereof to the member of the Board. (E) All costs and expenses approved by the President attributable to the employment of any member of the Board shall be payable from the Fund, including fees and mileage expenses for witnesses summoned by such members on the same basis and to the same extent as if such witnesses were summoned before a district court of the United States. (F) All decisions rendered by members of the Board shall be in writing, with notification to all appropriate parties, and shall be rendered within ninety days of submission of a claim to a member, unless all the parties to the claim agree in writing to an extension or unless the President extends the time limit pursuant to subparagraph (I) of this subsection. (G) All decisions rendered by members of the Board shall be final, and any party to the proceeding may appeal such a decision within thirty days of notification of the award or decision. Any such appeal shall be made to the Federal district court for the district where the arbitral hearing took place. In any such appeal, the award or decision of the member of the Board shall be considered binding and conclusive, and shall not be overturned except for arbitrary or capricious abuse of the member's discretion: Provided, however, That no such award or decision shall be admissible as evidence of any issue of fact or law in any proceeding brought under any other provision of this Act or under any other provision of law. Nor shall any prearbitral settlement reached pursuant to subsection (bX2XA) of this section be admissible as evidence in any such proceeding. (H) Within twenty days of the expiration of the appeal period for any arbitral award or decision, or within twenty days of the final judicial determination of any appeal taken pursuant to this subsection, the President shall pay any such award from the Fund. The President shall determine the method, terms, and time of payment. (1) If at any time the President determines that, because of a large number of claims arising from any incident or set of incidents, it is in the best interests of the parties concerned, he may extend the time for prearbitral negotiation or for rendering an arbitral decision pursuant to this subsection by a period not to exceed sixty days. He may also group such claims for submission to a member of the Board of Arbitrators. (cXD Payment of any claim by the Fund under this section shall be subject to the United States Government acquiring by subrogation the rights of the claimant to recover those costs of removal or damages for which it has compensated the claimant from the person responsible or liable for such release. (2) Any person, including the Fund, who pays compensation pursuant to this Act to any claimant for damages or costs resulting from a release of a hazardous substance shall be subrogated to all rights, claims, and causes of action for such damages and costs of. removal that the claimant has under this Act or any other law. (3) Upon request of the President, the Attorney General shall commence an action on behalf of the Fund to recover any compensation paid by the Fund to any claimant pursuant to this title, and, without regard to any limitation of liability, all interest, administrative and adjudicative costs, and attorney's fees incurred by the Fund by reason of the claim. Such an action may be commenced against any owner, operator, or guarantor, or against any other person who is �PUBLIC LAW 96-510—DEC. 11,1980 94 STAT. 2795 liable, pursuant to any law, to the compensated claimant or to the Fund, for the damages or costs for which compensation was paid. (d) No claim may be presented, nor may an action be commenced for damages under this title, unless that claim is presented or action commenced within three years from the date of the discovery of the loss or the date of enactment of this Act, whichever is later: Provided, however, That the time limitations contained herein shall not begin to run against a minor until he reaches eighteen years of age or a legal representative is duly appointed for him, nor against an incompetent person until his incompetency ends or a legal representative is duly appointed for him. (e) Regardless of any State statutory or common law to the contrary, no person who asserts a claim against the Fund pursuant to this title shall be deemed or held to have waived any other claim not covered or assertable against the Fund under this title arising from the same incident, transaction, or set of circumstances, nor to have split a cause of action. Further, no person asserting a claim against the Fund pursuant to this title shall as a result of any determination of a question of fact or law made in connection with that claim be deemed or held to be collaterally estopped from raising such question in connection with any other claim not covered or assertable against the Fund under this title arising from the same incident, transaction, or set of circumstances. LITIGATION, JURISDICTION AND VENUE SEC. 113. (a) Review of any regulation promulgated under this Act 42 use 9613. may be had upon application by any interested person only in the Circuit Court of Appeals of the United States for the District of Columbia. Any such application shall be made within ninety days from the date of promulgation of such regulations. Any matter with respect to which review could have been obtained under this subsection shall not be subject to judicial review in any civil or criminal proceeding for enforcement or to obtain damages or recovery of response costs. (b) Except as provided in subsection (a) of this section, the United States district courts shall have exclusive original jurisdiction over all controversies arising under this Act, without regard to the citizenship of the parties or the amount in controversy. Venue shall lie in any district in which the release or damages occurred, or in which the defendant resides, may be found, or has his principal office. For the purposes of this section, the Fund shall reside in the District of Columbia. (c) The provisions of subsections (a) and (b) of this section shall not apply to any controversy or other matter resulting from the assessment of collection of any tax, as provided by title II of this Act, or to the review of any regulation promulgated under the Internal Revenue Code Of 1954. 26 USC 1 «t seg. (d) No provision of this Act shall be deemed or held to moot any litigation concerning any release of any hazardous substance, or any damages associated therewith, commenced prior to enactment of this Act. RELATIONSHIP TO OTHER LAW SEC. 114. (a) Nothing in this Act shall be construed or interpreted as 42 use 9614. preempting any State from imposing any additional liability or �94 STAT. 2796 PUBLIC LAW 96-510—DEC. 11, 1980 requirements with respect to the release of hazardous substances within such State. (b) Any person who receives compensation for removal costs or damages or claims pursuant to this Act shall be precluded from recovering compensation for the same removal costs or damages or claims pursuant to any other State or Federal law. Any person who receives compensation for removal costs or damages or claims pursuant to any other Federal or State law shall be precluded from receiving compensation for the same removal costs or damages or claims as provided in this Act. (c) Except as provided in this Act, no person may be required to contribute to any fund, the purpose of which is to pay compensation for claims for any costs of response or damages or claims which may be compensated under this title. Nothing in this section shall preclude any State from using general revenues for such a fund, or from imposing a tax or fee upon any person or upon any substance in order to finance the purchase or prepositioning of hazardous substance response equipment or other preparations for the response to a release of hazardous substances which affects such State. (d) Except as provided in this title, no owner or operator of a vessel or facility who establishes and maintains evidence of financial responsibility in accordance with this title shall be required under any State or local law, rule, or regulation to establish or maintain any other evidence of financial responsibility in connection with liability for the release of a hazardous substance from such vessel or facility. Evidence of compliance with the financial responsibility requirements of this title shall be accepted by a State in lieu of any other requirement of financial responsibility imposed by such State in connection with liability for the release of a hazardous substance from such vessel or facility. AUTHORITY TO DELEGATE, ISSUE REGULATIONS 42 USC 9615. Hazardous Substance Response Revenue Act of 1980. 26 USC 1 note. 26 USC 1 et seq. SEC. 115. The President is authorized to delegate and assign any duties or powers imposed upon or assigned to him and to promulgate any regulations necessary to carry out the provisions of this title. TITLE II—HAZARDOUS SUBSTANCE RESPONSE REVENUE ACT OF 1980 SEC. 201. SHORT TITLE; AMENDMENT OF 1954 CODE. (a) SHORT TITLE.—This title may be cited as the "Hazardous Substance Response Revenue Act of 1980". (b) AMENDMENT OF 1954 CODE.—Except as otherwise expressly provided, whenever in this title an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Internal Revenue Code of 1954. �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2797 Subtitle A—Imposition of Taxes on Petroleum and Certain Chemicals SEC. 211. IMPOSITION OF TAXES. (a) GENERAL RULE.—Subtitle D (relating to miscellaneous excise taxes) is amended by inserting after chapter 37 the following new chapter: "CHAPTER 38-ENVIRONMENTAL TAXES "SuBCHAPTER A. Tax on petroleum. "SUBCHAPTEB B. Tax on certain chemicals. "Subchapter A—Tax on Petroleum "Sec. 4611. Imposition of tax. "Sec. 4612. Definitions and special rules. "SEC. 4611. IMPOSITION OP TAX. 26 USC 4611. "(a) GENERAL RULE.—There is hereby imposed a tax of 0.79 cent a barrel on— "(1) crude oil received at a United States refinery, and "(2) petroleum products entered into the United States for consumption, use, or warehousing, "(b) TAX ON CERTAIN USES AND EXPORTATION.— "(1) IN GENERAL.—If— "(A) any domestic crude oil is used in or exported from the United States, and "(B) before such use or exportation, no tax was imposed on such crude oil under subsection (a), then a tax of 0.79 cent a barrel is hereby imposed on such crude oil. "(2) EXCEPTION FOR USE ON PREMISES WHERE PRODUCED.—Paragraph (1) shall not apply to any use of crude oil for extracting oil or natural gas on the premises where such crude oil was produced, "(c) PERSONS LIABLE FOR TAX.— "(1) CRUDE OIL RECEIVED AT REFINERY.—The tax imposed by subsection (aXD shall be paid by the operator of the United States refinery. "(2) IMPORTED PETROLEUM PRODUCT.—The tax imposed by subsection (aX2) shall be paid by the person entering the product for consumption, use, or warehousing. "(3) TAX ON CERTAIN USES OR EXPORTS.—The tax imposed by subsection (b) shall be paid by the person using or exporting the crude oil, as the case may be. "(d) TERMINATION.—The taxes imposed by this section shall not apply after September 30,1985, except that if on September 30,1983, or September 30,1984— "(1) the unobligated balance in the Hazardous Substance Response Trust Fund as of such date exceeds $900,000,000, and "(2) the Secretary, after consultation with the Administrator of the Environmental Protection Agency, determines that such unobligated balance will exceed $500,000,000 on September 30 of the following year if no tax is imposed under section 4611 or 4661 Post, p. 2798. during the calendar year following the date referred to above. �94 STAT. 2798 PUBLIC LAW 96-510—DEC. 11, 1980 then no tax shall be imposed by this section during the first calendar year beginning after the date referred to in paragraph (1). 26 USC 4612. 26 use 638. Ante, p. 2797. "SBC. 4612. DEFINITIONS AND SPECIAL RULES. "(a) DEFINITIONS.—For purposes of this subchapter— "(1) CRUDE OIL,—The term 'crude oil' includes crude oil condensates and natural gasoline. "(2) DOMESTIC CRUDE OIL.—The term 'domestic crude oil' means any crude oil produced from a well located in the United States. (3) PETROLEUM PRODUCT.—The term 'petroleum product' includes crude oil. "(4) UNITED STATES.— "(A) IN GENERAL.—The term 'United States' means the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, any possession of the United States, the Commonwealth of the Northern Mariana Islands, and the Trust Territory of the Pacific Islands. "(B) UNITED STATES INCLUDES CONTINENTAL SHELF AREAS.— The principles of section 638 shall apply for purposes of the term 'United States'. "(C) UNITED STATES INCLUDES FOREIGN TRADE ZONES.—The term 'United States' includes any foreign trade zone of the United States. "(5) UNITED STATES REFINERY.—The term 'United States refinery' means any facility in the United States at which crude oil is refined. "(6) REFINERIES WHICH PRODUCE NATURAL GASOLINE.—In the case of any United States refinery which produces natural gasoline from natural gas, the gasoline so produced shall be treated as received at such refinery at the time so produced. "(7) PREMISES.—The term 'premises' has the same meaning as when used for purposes of determining gross income from the property under section 613. "(8) BARREL.—The term 'barrel' means 42 United States gallons. "(9) FRACTIONAL PART OF BARREL.—In the case of a fraction of a barrel, the tax imposed by section 4611 shall be the same fraction of the amount of such tax imposed on a whole barrel, "(b) ONLY 1 TAX IMPOSED WITH RESPECT TO ANY PRODUCT.—No tax shall be imposed by section 4611 with respect to any petroleum product if the person who would be liable for such tax establishes that a prior tax imposed by such section has been imposed with respect to such product. "(c) DISPOSITION OF REVENUES FROM PUERTO Rico AND THE VIRGIN ISLANDS.—The provisions of subsections (aX3) and (bX3) of section 7652 shall not apply to any tax imposed by section 4611. "Subchapter B—Tax on Certain Chemicals "Sec. 4661. Imposition of tax. "Sec. 4662. Definitions and special rules. 26 USC 4661. "SEC. 4661. IMPOSITION OF TAX. "(a) GENERAL RULE.—There is hereby imposed a tax on any taxable chemical sold by the manufacturer, producer, or importer thereof. "(b) AMOUNT OF TAX.—The amount of the tax imposed by subsection (a) shall be determined in accordance with the following table: �PUBLIC LAW 96-510—DEC. 11,1980 "In the cue oft Acetylene Benzene Butane Butylene Butadiene Arsenic trioxide Barium sulfide Bromine Cadmium Chlorine..... Chromium Chromite Potassium dichromate Sodium dichromate Cobalt Cupric sulfate Cupric oxide Cuprous oxide Hydrochloric add Hydrogen Lead oxide Mercury The tax is the following amount per ton $4.87 4.87 4.87 4.87 4.87 : Ethylene Methane Naphthalene Propylene Toluene Xylene Ammonia Antimony Antimony trioxide Arsenic 94 STAT. 2799 '.'.". 4.87 3.44 4.87 4.87 4.87 4.87 2.64 4.45 3.75 4.45 i 3.41 2.30 4.45 4.45 2.70 4.45 1.52 1.69 1.87 4.45 1.87 3.59 .'. fluoride 3.97 0.29 4.23 4.14 4.45 Nickel 4.45 Phosphorus 4.45 Stannous chloride 2.85 Stannic chloride 2.12 Zinc chloride. 2.22 Zinc sulfate 1.90 Potassium hydroxide 0.22 Sodium hydroxide 0.28 Sulfuricacid 0.26 Nitric acid 0.24 "(c) TERMINATION.—No tax shall be imposed under this section during any period during which no tax is imposed under section 4611(a). "SEC. 4662. DEFINITIONS AND SPECIAL RULES. 26 USC 4662. "(a) DEFINITIONS.—For purposes of this subchapter— "(1) TAXABLE CHEMICAL.—Except as provided in subsection (b), the term 'taxable chemical' means any substance— "(A) which is listed in the table under section 4661(b), and Ante, P. 2798. "(B) which is manufactured or produced in the United States or entered into the United States for consumption, use, or warehousing. "(2) UNITED STATES.—The term 'United States' has the mean- Ante 2798 ing given such term by section 4612(aX4). -P "(3) IMPORTER.—The term 'importer' means the person entering the taxable chemical for consumption, use, or warehousing. "(4) TON.—The term 'ton' means 2,000 pounds. In the case of any taxable chemical which is a gas, the term 'ton' means the amount of such gas in cubic feet which is the equivalent of 2,000 pounds on a molecular weight basis. �94 STAT. 2800 Ante, p. 2798. PUBLIC LAW 96-510-DEC. 11, 1980 "(5) FRACTIONAL PART OF TON.—In the case of a fraction of a ton, the tax imposed by section 4661 shall be the same fraction of the amount of such tax imposed oh a whole ton. "(b) EXCEPTIONS; OTHER SPECIAL RULES.—For purposes of this subchapter— "(1) METHANE OR BUTANE USED AS A FUEL.—Under regulations prescribed by the Secretary, methane or butane shall be treated as a taxable chemical only if it is used otherwise than as a fuel (and, for purposes of section 4661(a), the person so using it shall be treated as the manufacturer thereof). "(2) SUBSTANCES USED IN THE PRODUCTION OF FERTILIZER.— "(A) IN GENERAL.—In the case of nitric acid, sulfuric acid, ammonia, or methane used to produce ammonia which is a qualified substance, no tax shall be imposed under section 4661(a). "(B) QUALIFIED SUBSTANCE.—For purposes of this section, the term 'qualified substance' rileans any substance— "(i) used in a qualified use by the manufacturer, producer, or importer, "(ii) sold for use by the purchaser in a qualified use, or "(iii) sold for resale by the purchaser to a second purchaser for use by such second purchaser in a qualified use. "(C) QUALIFIED USE.—For purposes of this subsection, the term 'qualified use' means any use in the manufacture or production of a fertilizer. "(3) SULFURIC ACID PRODUCED AS A BYPRODUCT OF AIR POLLUTION CONTROL.—In the case of sulfuric acid produced solely as a byproduct of and on the same site as air pollution control equipment, no tax shall be imposed under section 4661. "(4) SUBSTANCES DERIVED FROM COAL.—For purposes Of this subchapter, the term 'taxable chemical' shall not include any substance to the extent derived from coal. "(c) USE BY MANUFACTURER, ETC., CONSIDERED SALE.—If any person* manufactures, produces, or imports a taxable chemical and uses such chemical, then such person shall be liable for tax Under section 4661 in the same manner as if such chemical were sold by such person. "(d) REFUND OR CREDIT FOR CERTAIN USES.— "(1) IN GENERAL.—Under regulations prescribed by the Secretary, if— "(A) a tax under section 4661 was paid with respect to any taxable chemical, and "(Bj such Chemical was used by any person in the manufacture or production of any other substance the sale of which by siich person would be taxable under such section, then an amount equal to the tax so paid shall be allowed as a credit or refund (without interest) to such person in the same manner as if it were an overpayment of tax imposed by such section. In any case to which this paragraph applies, the amount of any such credit or refund shall not exceed the amount of tax imposed by such section on the other substance manufactured or produced. "(2) USE AS FERTILIZER.—Under regulations prescribed by the Secretary, if— "(A) a tax under section 4661 was paid with respect to nitric acid, sulfuric acid, ammonia, or methane used to make ammonia without regard to subsection (bX2), and �PUBLIC LAW 96-510—DEC. 11,1980 94 STAT. 2801 "(B) any person uses such substance, or sells such substance for use, as a qualified substance, then an amount equal to the excess of the tax so paid over the tax determined with regard to subsection (bX2) shall be allowed as a credit or refund (without interest) to such person in the same manner as if it were an overpayment of tax imposed by this section. "(e) DISPOSITION OF REVENUES FROM PUERTO Rico AND THE VIRGIN ISLANDS.—The provisions of subsections (aX3) and (bX3) of section 7652 shall not apply to any tax imposed by section 4661.". (b) CLERICAL AMENDMENT.—The table of chapters for subtitle D is amended by inserting after the item relating to chapter 37 the following new item: 26 USC 7652. Ante, p. 2798. "CHAPTER 38. Environmental taxes.". (c) EFFECTIVE DATE.—The amendments made by this section shall take effect on April 1,1981. 26 USC 4611 note. Subtitle B—Establishment of Hazardous Substance Response Trust Fund SEC. 221. ESTABLISHMENT OF HAZARDOUS SUBSTANCE RESPONSE TRUST 42 USC 9631. FUND. (a) CREATION OF TRUST FUND.—There is established in the Treasury of the United States a trust fund to be known as the "Hazardous Substance Response Trust Fund" (hereinafter in this subtitle referred to as the "Response Trust Fund"), consisting of such amounts as may be appropriated or transferred to such Trust Fund as provided in this section. (b) TRANSFERS TO RESPONSE TRUST FUND.— (1) AMOUNTS EQUIVALENT TO CERTAIN TAXES, ETC.—There are hereby appropriated, out of any money in the Treasury not otherwise appropriated, to the Response Trust Fund amounts determined by the Secretary of the Treasury (hereinafter in this subtitle referred to as the "Secretary") to be equivalent to— (A) the amounts received in the Treasury under section 4611 or 4661 of the Internal Revenue Code of 1954, (B) the amounts recovered on behalf of the Response Trust Fund under this Act, (C) all moneys recovered or collected under section 311(bX6XB) of the Clean Water Act, (D) penalties assessed under title I of this Act, and (E) punitive damages under section 107(cX8) of this Act. (2) AUTHORIZATION FOR APPROPRIATIONS.—There is authorized to be appropriated to the Emergency Response Trust Fund for fiscal year— (A) 1981, $ 4 0 0 0 0 4,0,0, ( ) 1982, $ 4 0 0 0 0 B 4,0,0, ( ) 1983, $ 4 0 0 0 0 C 4,0,0, ( ) 1984, $ 4 0 0 0 0 and D 4,0,0, (E) 1985, $44,000,000, plus an amount equal to so much of the aggregate amount authorized to be appropriated under subparagraphs (A), (B), (C), and (D) as has not been appropriated before October 1,1984. (3) TRANSFER OF FUNDS.—There shall be transferred to the Response Trust Fund— Ante, pp. 2797, 2798. 33 USC 1321. �94 STAT. 2802 33 use 1321. 42 USC 9632. PUBLIC LAW 96-510—DEC. 11, 1980 (A) one-half of the unobligated balance remaining before the date of the enactment of this Act under the Fund in section 311 of the Clean Water Act, and (B) the amounts appropriated under section 504(b) of the Clean Water Act during any fiscal year. (c) EXPENDITURES FROM RESPONSE TRUST FUND.— (1) IN GENERAL.—Amounts in the Response Trust Fund shall be available in connection with releases or threats of releases of hazardous substances into the environment only for purposes of making expenditures which are described in section 111 (other than subsection (j) thereof) of this Act, as in effect on the date of the enactment of this Act, including— (A) response costs, (B) claims asserted and compensable but unsatisfied under section 311 of the Clean Water Act, (C) claims for injury to, or destruction or loss of, natural resources, and (D) related costs described in section lll(c) of this Act. (2) LIMITATIONS ON EXPENDITURES.—At least 85 percent of the amounts appropriated to the Response Trust Fund under subsection (b) (1XA) and (2) shall be reserved— (A) for the purposes specified in paragraphs (1), (2), and (4) of section lll(a) of this Act, and (B) for the repayment of advances made under section 223(c), other than advances subject to the limitation of section 223(cX2XC). SEC. 222. LIABILITY OF UNITED STATES LIMITED TO AMOUNT IN TRUST FUND. (a) GENERAL RULE.—Any claim filed against the Response Trust Fund may be paid only out of such Trust Fund. Nothing in this Act (or in any amendment made by this Act) shall authorize the payment by the United States Government of any additional amount with respect to any such claim out of any source other than the Response Trust Fund. (b) ORDER IN WHICH UNPAID CLAIMS ARE To BE PAID.—If at any time the Response Trust Fund is unable (by reason of subsection (a) or the limitation of section 221(cX2)) to pay all of the claims payable out of such Trust Fund at such time, such claims shall, to the extent permitted under subsection (a), be paid in full in the order in which they were finally determined. 42 USC 9633. SEC. 223. ADMINISTRATIVE PROVISIONS. (a) METHOD OF TRANSFER.—The amounts appropriated by section 221(bXD shall be transferred at least monthly from the general fund of the Treasury to the Response Trust Fund on the basis of estimates made by the Secretary of the amounts referred to in such section, Proper adjustments shall be made in the amount subsequently transferred to the extent prior estimates were in excess of or less than the amounts required to be transferred. (b) MANAGEMENT OF TRUST FUND.— (1) REPORT.—The Secretary shall be the trustee of the Response Trust Fund, and shall report to the Congress for each fiscal year ending on or after September 30,1981, on the financial condition and the results of the operations of such Trust Fund during such fiscal year and on its expected condition and operations during the next 5 fiscal years. Such report shall be printed as a House �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2803 document of the session of the Congress to which the report is made. (2) INVESTMENT.—It shall be the duty of the Secretary to invest such portion of such Trust Fund as is not, in his judgment, required to meet current withdrawals. Such investments shall be in public debt securities with maturities suitable for the needs of such Trust Fund and bearing interest at rates determined by the Secretary, taking into consideration current market yields on outstanding marketable obligations of the United States of comparable maturities. The income on such investments shall be credited to and form a part of such Trust Fund, (c) AUTHORITY To BORROW.— (1) IN GENERAL.—There are authorized to be appropriated to Appropriation the Response Trust Fund, as repayable advances, such sums as authorization. may be necessary to carry out the purposes of such Trust Fund. (2) LIMITATIONS ON ADVANCES TO RESPONSE TRUST FUND.— (A) AGGREGATE ADVANCES.—The maximum aggregate amount of repayable advances to the Response Trust Fund which is outstanding at any one time shall not exceed an amount which the Secretary estimates will be equal to the sum of the amounts which will be appropriated or transferred to such Trust Fund under paragraph (1XA) of section 221(b) of this Act for the following 12 months, and (B) ADVANCES FOR PAYMENT OF RESPONSE COSTS.—No amount may be advanced after March 31, 1983, to the Response Trust Fund for the purpose of paying response costs described in section lll(a) (1), (2), or (4), unless such costs are incurred incident to any spill the effects of which the Secretary determines to be catastrophic. (C) ADVANCES FOR OTHER COSTS.—The maximum aggregate amount advanced to the Response Trust Fund which is outstanding at any one time for the purpose of paying costs other than costs described in section 11 Ha) (1), (2), or (4) shall not exceed one-third of the amount of the estimate made under subparagraph (A). (D) FINAL REPAYMENT.—No advance shall be made to the Response Trust Fund after September 30, 1985, and all advances to such Fund shall be repaid on or before such date. (3) REPAYMENT OF ADVANCES.—Advances made pursuant- to this subsection shall be repaid, and interest on such advances shall be paid, to the general fund of the Treasury when the Secretary determines that moneys are available for such purposes in the Trust Fund to which the advance was made. Such interest shall be at rates computed in the same manner as provided in subsection (b) and shall be compounded annually. Subtitle C—Post-Closure Tax and Trust Fund SEC. 231. IMPOSITION OP TAX. (a) IN GENERAL.—Chapter 38, as added by section 211, is amended by adding at the end thereof the following new subchapter: "Subchapter C—Tax on Hazardous Wastes "Sec. 4681. Imposition of tax. "Sec. 4682. Definitions and special rules. �94 STAT. 2804 26 USC 4681. PUBLIC LAW 96-510—DEC. 11,1980 "SEC. 4681. IMPOSITION OF TAX. "(a) GENERAL RULE.—There is hereby imposed a tax on the receipt of hazardous waste at a qualified hazardous waste disposal facility. "(b) AMOUNT OF TAX.—The amount of the tax imposed by subsection (a) shall be equal to $2.13 per dry weight ton of hazardous waste. 26 USC 4682. 42 USC 6921. 42 USC 6922, 6924. "SEC. 4682. DEFINITIONS AND SPECIAL RULES. "(a) DEFINITIONS.—For purposes of this subchapter— "(1) HAZARDOUS WASTE.—The term 'hazardous waste' means any waste— "(A) having the characteristics identified under section 3001 of the Solid Waste Disposal Act, as in effect on the date of the enactment of this Act (other than waste the regulation of which under such Act has been suspended by Act of Congress on that date), or "(B) subject to the reporting or recordkeeping requirements of sections 3002 and 3004 of such Act, as so in effect. "(2) QUALIFIED HAZARDOUS WASTE DISPOSAL FACILITY.—The term 'qualified hazardous waste disposal facility* means any facility which has received a permit or is accorded interim status 42 USC 6925. "(b) TAX IMPOSED ON OWNER OR OPERATOR.—The tax imposed by section 4681 shall be imposed on the owner or operator of the qualified hazardous waste disposal facility. "(c) TAX Nor To APPLY TO CERTAIN WASTES.—The tax imposed by section 4681 shall not apply to any hazardous waste which will not remain at the qualified hazardous waste disposal facility after the facility is closed. "(d) APPLICABILITY OF SECTION.—The tax imposed by section 4681 shall apply to the receipt of hazardous waste after September 30, 1983, except that if, as of September 30 of any subsequent calendar year, the unobligated balance of the Post-closure Liability Trust Fund exceeds $200,000,000, no tax shall be imposed under such section during the following calendar year.". (b) CONFORMING AMENDMENT.—The table of subchapters for chapter 38 is amended by adding at the end thereof the following new item: "SUBCHAPTKH C—Tax on Hazardous Wastes.". 42 USC 9641. SEC. 232. POST-CLOSURE LIABILITY TRUST FUND. (a) CREATION OF TRUST FUND.—There is established in the Treasury of the United States a trust fund to be known as the "Post-closure Liability Trust Fund", consisting of such amounts as may be appropriated, credited, or transferred to such Trust Fund. (b) EXPENDITURES FROM POST-CLOSURE LIABILITY TRUST FUND.— Amounts in the Post-closure Liability Trust Fund shall be available only for the purposes described in sections 107(k) and lll(j) of this Act (as in effect on the date of the enactment of this Act). (c) ADMINISTRATIVE PROVISIONS.—The provisions of sections 222 and 223 of this Act shall apply with respect to the Trust Fund established under this section, except that the amount of any repayable advances outstanding at any one time shall not exceed $200,000,000. �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2805 TITLE HI-MISCELLANEOUS PROVISIONS REPORTS AND STUDIES SEC. 301. (aXD The President shall submit to the Congress, within 42 use 9651. four years after enactment of this Act, a comprehensive report on experience with the implementation of this Act, including, but not limited to— (A) the extent to which the Act and Fund are effective in enabling Government to respond to and mitigate the effects of releases of hazardous substances; (B) a summary of past receipts and disbursements from the Fund; (C) a projection of any future funding needs remaining after the expiration of authority to collect taxes, and of the threat to public health, welfare, and the environment posed by the projected releases which create any such needs; (D) the record and experience of the Fund in recovering Fund disbursements from liable parties; (E) the record of State participation in the system of response, liability, and compensation established by this Act; (F) the impact of the taxes imposed by title II of this Act on the Nation's balance of trade with other countries; (G) an assessment of the feasibility and desirability of a schedule of taxes which would take into account one or more of the following: the likelihood of a release of a hazardous substance, the degree of hazard and risk of harm to public health, welfare, and the environment resulting from any such release, incentives to proper handling, recycling, incineration, and neutralization of hazardous wastes, and disincentives to improper or illegal handling or disposal of hazardous materials, administrative and reporting burdens on Government and industry, and the extent to which the tax burden falls on the substances and parties which create the problems addressed by this Act. In preparing the report, the President shall consult with appropriate Federal, State, and local agencies, affected industries and claimants, and such other interested parties as he may find useful. Based upon the analyses and consultation required by this subsection, the President shall also include in the report any recommendations for legislative changes he may deem necessary for the better effectuation of the purposes of this Act, including but not limited to recommendations concerning authorization (H) an exemption from or an increase in the substances or the amount of taxes imposed by section 4661 of the Internal Revenue Code of 1954 for copper, lead, and zinc oxide, and for feedstocks Ante. p. 2798. when used in the manufacture and production of fertilizers, based upon the expenditure experience of the Response Trust Fund; (I) the economic impact of taxing coal-derived substances and recycled metals. (2) The Administrator of the Environmental Protection Agency (in consultation with the Secretary of the Treasury) shall submit to the Congress (i) within four years after enactment of this Act, a report identifying additional wastes designated by rule as hazardous after the effective date of this Act and pursuant to section 3001 of the Solid �94 STAT. 2806 42 USC 6921. Ante, p. 2336. Ante, p. 2781. Regulations. Ante, p. 2779. 33 USC 1321. • Review and revision. PUBLIC LAW 96-510—DEC. 11,1980 Waste Disposal Act and recommendations on appropriate tax rates for such wastes for the Post-closure Liability Trust Fund. The report shall, in addition, recommend a tax rate, considering the quantity and potential danger to human health and the environment posed by the disposal of any wastes which the Administrator, pursuant to subsection 3001(bX2XB) and subsection 3001(bX3XA) of the Solid Waste Disposal Act of 1980, has determined should be subject to regulation under subtitle C of such Act, (ii) within three years after enactment of this Act, a report on the necessity for and the adequacy of the revenue raised, in relation to estimated future requirements, of the Post-closure Liability Trust Fund. (b) The President shall conduct a study to determine (1) whether adequate private insurance protection is available on reasonable terms and conditions to the owners and operators of vessels and facilities subject to liability under section 107 of this Act, and (2) whether the market for such insurance is sufficiently competitive to assure purchasers of features such as a reasonable range of deductibles, coinsurance provisions, and exclusions. The President shall submit the results of his study, together with his recommendations, within two years of the date of enactment of this Act, and shall submit an interim report on his study within one year of the date of enactment of this Act. (cXD The President, acting through Federal officials designated by the National Contingency Plan published under section 105 of this Act, shall study and, not later than two years after the enactment of this Act, shall promulgate regulations for the assessment of damages for injury to, destruction of, or loss of natural resources resulting from a release of oil or a hazardous substance for the purposes of this Act and section 311(f) (4) and (5) of the Federal Water Pollution Control Act. (2) Such regulations shall specify (A) standard procedures for simplified assessments requiring minimal field observation, including establishing measures of damages based on units of discharge or release or units of affected area, and (B) alternative protocols for conducting assessments in individual cases to determine the type and extent of short- and long-term injury, destruction, or loss. Such regulations shall identify the best available procedures to determine such damages, including both direct and indirect injury, destruction, or loss and shall take into consideration factors including, but not limited to, replacement value, use value, and ability of the ecosystem or resource to recover. (3) Such regulations shall be reviewed and revised as appropriate every two years. (d) The Administrator of the Environmental Protection Agency shall, in consultation with other Federal agencies and appropriate representatives of State and local governments and nongovernmental agencies, conduct a study and report to the Congress within two years of the date of enactment of this Act on the issues, alternatives, and policy considerations involved in the selection of locations for hazardous waste treatment, storage, and disposal facilities. This study shall include— (A) an assessment of current and projected treatment, storage, and disposal capacity needs and shortfalls for hazardous waste by management category on a State-by-State basis; (B) an evaluation of the appropriateness of a regional approach to siting and designing hazardous waste management facilities and the identification of hazardous waste management regions, �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2807 interstate or intrastate, or both, with similar hazardous waste management needs; (C) solicitation and analysis of proposals for the construction and operation of hazardous waste management facilities by nongovernmental entities, except that no proposal solicited under terms of this subsection shall be analyzed if it involves cost to the United States Government or fails to comply with the requirements of subtitle C of the Solid Waste Disposal Act and 42 use 6921. other applicable provisions of law; (D) recommendations on the appropriate balance between public and private sector involvement in the siting, design, and operation of new hazardous waste management facilities; (E) documentation of the major reasons for public opposition to new hazardous waste management facilities; and (F) an evaluation of the various options for overcoming obstacles to siting new facilities, including needed legislation for implementing the most suitable option or options, (eXD In order to determine the adequacy of existing common law and statutory remedies in providing legal redress for harm to man and the environment caused by the release of hazardous substances into the environment, there shall be submitted to the Congress a study within twelve months of enactment of this Act. (2) This study shall be conducted with the assistance of the American Bar Association, the American Law Institute, the Association of American Trial Lawyers, and the National Association of State Attorneys General with the President of each entity selecting three members from each organization to conduct the study. The study chairman and one reporter shall be elected from among the twelve members of the study group. (3) As part of their review of the adequacy of existing common law and statutory remedies, the study group shall evaluate the following: (A) the nature, adequacy, and availability of existing remedies under present law in compensating for harm to man from the release of hazardous substances; (B) the nature of barriers to recovery (particularly with respect to burdens of going forward and of proof and relevancy) and the role such barriers play hi the legal system; (C) the scope of the evidentiary burdens placed on the plaintiff in proving harm from the release of hazardous substances, particularly in light of the scientific uncertainty over causation with respect to— (i) carcinogens, mutagens, and teratogens, and (ii) the human health effects of exposure to low doses of hazardous substances over long periods of time; (D) the nature and adequacy of existing remedies under present law in providing compensation for damages to natural resources from the release of hazardous substances; (E) the scope of liability under existing law and the consequences, particularly with respect to obtaining insurance, of any changes in such liability; (F) barriers to recovery posed by existing statutes of limitations. (4) The report shall be submitted to the Congress with appropriate recommendations. Such recommendations shall explicitly address— (A) the need for revisions in existing statutory or common law, and �94 STAT. 2808 PUBLIC LAW 96-510—DEC. 11, 1980 (B) whether such revisions should take the form of Federal statutes or the development of a model code which is recommended for adoption by the States. (5) The Fund shall pay administrative expenses incurred for the study. No expenses shall be available to pay compensation, except expenses on a per diem basis for the one reporter, but in no case shall the total expenses of the study exceed $300,000. (f) The President, acting through the Administrator of the Environmental Protection Agency, the Secretary of Transportation, the Administrator of the Occupational Safety and Health Administration, and the Director of the National Institute for Occupational Safety and Health shall study and, not later than two years after the enactment of this Act, shall modify the national contingency plan to provide for the protection of the health and safety of employees involved in response actions. EFFECTIVE DATES, SAVINGS PROVISION 42 use 9652. 33 use 1321. gECi 302. (a) Unless otherwise provided, all provisions of this Act shall be effective on the date of enactment of this Act. (b) Any regulation issued pursuant to any provisions of section 311 of the Clean Water Act which is repealed or superseded by this Act and which is in effect on the date immediately preceding the effective date of this Act shall be deemed to be a regulation issued pursuant to the authority of this Act and shall remain in full force and effect unless or until superseded by new regulations issued thereunder. (c) Any regulation— (1) respecting financial responsibility, (2) issued pursuant to any provision of law repealed or superseded by this Act, and (3) in effect on the date immediately preceding the effective date of this Act shall be deemed to be a regulation issued pursuant to the authority of this Act and shall remain in full force and effect unless or until superseded by new regulations issued thereunder. (d) Nothing in this Act shall affect or modify in any way the obligations or liabilities of any person under other Federal or State law, including common law, with respect to releases of hazardous substances or other pollutants or contaminants. The provisions of this Act shall not be considered, interpreted, or construed in any way as reflecting a determination, in part or whole, of policy regarding the inapplicability of strict liability, or strict liability doctrines, to activities relating to hazardous substances, pollutants, or contaminants or other such activities. EXPIRATION, SUNSET PROVISION 42 USC 9653. Ante, pp. 2797, SEC. 303. Unless reauthorized by the Congress, the authority to collect taxes conferred by this Act shall terminate on September 30, 1985, or when the sum of the amounts received in the Treasury under section 4611 and under 4661 of the Internal Revenue Code of 1954 total $1,380,000,000, whichever occurs first. The Secretary of the Treasury shall estimate when this level of $1,380,000,000 will be reached and shall by regulation, provide procedures for the termination of the tax authorized by this Act and imposed under sections 4611 and 4661 of the Internal Revenue Code of 1954. �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2809 CONFORMING AMENDMENTS SEC. 304. (a) Subsection (b) of section 504 of the Federal Water Pollution Control Act is hereby repealed. (b) One-half of the unobligated balance remaining before the date of the enactment of this Act under subsection (k) of section 311 of the Federal Water Pollution Control Act and all sums appropriated under section 504(b) of the Federal Water Pollution Control Act shall be transferred to the Fund established under title II of this Act. (c) In any case in which any provision of section 311 of the Federal Water Pollution Control Act is determined to be in conflict with any provisions of this Act, the provisions of this Act shall apply. 33 usc 1364 42 usc 9654 33 usc 1321. LEGISLATIVE VETO SEC. 305. (a) Notwithstanding any other provision of law, simulta- 42 usc 9655. neously with promulgation or repromulgation of any rule or regulation under authority of title I of this Act, the head of the department, agency, or instrumentality promulgating such rule or regulation shall transmit a copy thereof to the Secretary of the Senate and the Clerk of the House of Representatives. Except as provided in subsection (b) of this section, the rule or regulation shall not become effective, if— (1) within ninety calendar days of continuous session of Congress after the date of promulgation, both Houses of Congress adopt a concurrent resolution, the matter after the resolving clause of which is as follows: "That Congress disapproves the rule or regulation promulgated by the dealing with the matter of , which rule or regulation was transmitted to Congress on .", the blank spaces therein being appropriately filled; or (2) within sixty calendar days of continuous session of Congress after the date of promulgation, one House of Congress adopts such a concurrent resolution and transmits such resolution to the other House, and such resolution is not disapproved by such other House within thirty calendar days of continuous session of Congress after such transmittal. (b) If, at the end of sixty calendar days of continuous session of Congress after the date of promulgation of a rule or regulation, no committee of either House of Congress has reported or been discharged from further consideration of a concurrent resolution disapproving the rule or regulation and neither House has adopted such a resolution, the rule or regulation may go into effect immediately. If, within such sixty calendar days, such a committee has reported or been discharged from further consideration of such a resolution, or either House has adopted such a resolution, the rule or regulation may go into effect not sooner than ninety calendar days of continuous session of Congress after such rule is prescribed unless disapproved as provided in subsection (a) of this section. (c) For purposes of subsections (a) and (b) of this section— (1) continuity of session is broken only by an adjournment of Congress sine die; and (2) the days on which either House is not in session because of an adjournment of more than three days to a day certain are excluded in the computation of thirty, sixty, and ninety calendar days of continuous session of Congress. �94 STAT. 2810 PUBLIC LAW 96-510—DEC. 11, 1980 (d) Congressional inaction on, or rejection of, a resolution of disapproval shall not be deemed an expression of approval of such rule or regulation. TRANSPORTATION 42 USC 9656. Ante, p. 2767. 49 USC 1801 note. Ante, p. 2781. 49 USC 10541. SEC. 306. (a) Each hazardous substance which is listed or designated as provided in section 101(14) of this Act shall, within ninety days after the date of enactment of this Act or at the time of such listing or designation, whichever is later, be listed as a hazardous material under the Hazardous Materials Transportation Act. (b) A common or contract carrier shall be liable under other law in lieu of section 107 of this Act for damages or remedial action resulting from the release of a hazardous substance during the course of transportation which commenced prior to the effective date of the listing of such substance as a hazardous material under the Hazardous Materials Transportation Act, or for substances listed pursuant to subsection (a) of this section, prior to the effective date of such listing: Provided, however, That this subsection shall not apply where such a carrier can demonstrate that he did not have actual knowledge of the identity or nature of the substance released. (c) Section 11901 of title 49, United States Code, is amended byCD redesignating subsection (h) as subsection (i); (2) by inserting "and subsection (h)" after "subsection (g)" in subsection (iX2) as so redesignated by paragraph (1) of this subsection; and (3) by inserting the following new subsection (h): "(h) A person subject to the jurisdiction of the Commission under subchapter II of chapter 105 of this title, or an officer, agent, or employee of that person, and who is required to comply with section 10921 of this title but does not so comply with respect to the transportation of hazardous wastes as defined by the Environmental Protection Agency pursuant to section 3001 of the Solid Waste Disposal Act (but not including any waste the regulation of which under the Solid Waste Disposal Act has been suspended by Congress) shall, in any action brought by the Commission, be liable to the United States for a civil penalty not to exceed $20,000 for each violation.". ASSISTANT ADMINISTRATOR FOR SOLID WASTE 42 USC 6911. 42 USC 6911a. 5 USC app; 42 USC 4321 note. 15 USC 2601 note. Effective date. 42 USC 6911 note. SEC. 307. (a) Section 2001 of the Solid Waste Disposal Act is amended by striking out "a Deputy Assistant" and inserting in lieu thereof "an Assistant". (b) The Assistant Administrator of the Environmental Protection Agency appointed to head the Office of Solid Waste shall be in addition to the five Assistant Administrators of the Environmental Protection Agency provided for in section l(d) of Reorganization Plan Numbered 3 of 1970 and the additional Assistant Administrator provided by the Toxic Substances Control Act, shall be appointed by the President by and with the advice and consent of the Senate, and shall be compensated at the rate provided for Level IV of the Executive Schedule pay rates under section 5315 of title 5, United States Code. (c) The amendment made by subsection (a) shall become effective ninety days after the date of the enactment of this Act. �PUBLIC LAW 96-510—DEC. 11, 1980 94 STAT. 2811 SEPARABILITY SEC. 308. If any provision of this Act, or the application of any 42 use 9657. provision of this Act to any person or circumstance, is held invalid, the application of such provision to other persons or circumstances and the remainder of this Act shall not be affected thereby. Approved December 11, 1980. LEGISLATIVE HISTORY: HOUSE REPORTS: No. 96-1016, pt. I (Comm. on Interstate and Foreign Commerce) and No. 96-1016, Pt. II (Comm. on Ways and Means). SENATE REPORT No. 96-848 accompanying S. 1480 (Comm. on Environment and Public Works). CONGRESSIONAL RECORD, Vol. 126 (1980): Sept. 18, 19, 23, considered and passed House. Nov. 24, considered and passed Senate, amended, in lieu of S. 1480. Dec. 3, House concurred in Senate amendments. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 16, No. 50: Dec. 11, Presidential statement. � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 184 Folder The folder containing the original item. 5347 Series The series number of the original item. Series VIII Subseries I Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Description An account of the resource <strong>Corporate Author: </strong>United States Environmental Protection Agency (EPA) Date A point or period of time associated with an event in the lifecycle of the resource December 11 1980 Title A name given to the resource CERCLA: Comprehensive Environmental Response, Compensation, and Liability Act of 1980. ao_seriesVIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 197 Folder The folder containing the original item. 5527 Series The series number of the original item. Series VIII Subseries I Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Stanley, John S. Kathy E. Boggess John E. Going Gregory A. Mack Janet C. Remmers Joseph J. Breen Frederick W. Kutz Joseph Carra Philip Robinson Source A related resource from which the described resource is derived Environmental Epidemiology Date A point or period of time associated with an event in the lifecycle of the resource 1986 Title A name given to the resource Chapter 14: Broad Scan Analysis of Human Adipose Tissue from the EPA FY82 NHATS Repository ao_seriesVIII Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 185 Folder The folder containing the original item. 5365 Series The series number of the original item. Series VIII Subseries I Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Klein R. Source A related resource from which the described resource is derived Wounded Men, Broken Promises Date A point or period of time associated with an event in the lifecycle of the resource 1981 Title A name given to the resource Chapter 6: The Poison Orange ao_seriesVIII