6 15 672 https://www.nal.usda.gov/exhibits/speccoll/files/original/aaebddbb9cd89b8f06cea10d6b3d3e64.pdf e9e1a2e7911e8de5787ee24d910e65c4 PDF Text Text Item D Number °5746 U Not Scanned Author Corporate Author Report/Article Title Charter of New Veterans Administration Advisory Committee Journal/Book Title Year Month/Day Color Number of Images September 20 n ° Descriptor) Notes Thursday, March 28, 2002 Page 5746 of 5780 �CKAP.TF.K OF KCW VETERAlir. ADMINISTRATION ADVISORY COMMITTEE A, O F F I C I A L DESIGNATION: ADVISORY COfiMITTf/.P. O?? I1EALTH-RFI.ATED ~.......'. . . " * ...... "**" EFFECTS OF liEKP.ICIDEfi B. OEJ CCTI VT.S JWD SC_OPJj OP ..ACTIVITY t It has teco.rttly b^c-n biounhi. to 1 Icht that enormous q u a n t i t i e s ol h f v b i c i r l a l chenicnls wctt» used tfuri.no the Vietnam Wat and that thorn* i*i a p o s s i b i l i t y t b u t lame nunbets of Americans, rrary of vhorr- now f j u a i i t y as v e t e r a n s , I'-.ny have encountered these c h e m i c a l s to en extent that Icnu ran«e r.icnif iconl h p n l t h er,i^ nay hAvc hecn i n i l i A t e d . Thocc ic consider chlf 1 - cyntto* in tb^ p u b i i r » h e r l l i t o t a t x i r c ano it is ptohaMo that ruch infof.rs.tiop, i:f.Hiatr.s ar.put J ir.bccl. The V e t e r a n s Adr..inictration ti«;- r.ot M «' vio:u~ Iy br-«»n l o c ' u i t u d to r-r-uolve tor icoloT icfll i'jauos of such A corpiox fncl hinh.lv conttover v.ial n ^ t i u e . Thy corutittee w i l l , Uuuofotf:, (Sr.F.frrjblo and <^n«lys;e the information v>-hich th<? Vet'-'itn:-; jV.ninistiation r.recE in or-ler to f o r r u i a t f appto;;i - i a t < r . O f ' i c f l l policy an.; r-toc^c'ui oa in the i n t o r o a t j ; of the? ir.volva vc ts?ta:\s . Thf; Corr-. i tt»><* w i i i h&ve an o n t i t c l y i",;,ct~f inr". ino ^r.c ncjviijoi y i.olo «n«:l w i l l not be f-2-ouit^d to develop policy, Tho Cor.nittoo w i l J a-lhoic to fill Uio provir,ions of U, S. 1'ublic f.r.v * 0 2 - 4 r « 3 , T, U . i i . C . An p. I r r.y^cut ive Ctdet <?li769 anfi P f r s i f ^ n t l A l C i t c u l c s t 4A-63, of Katch 27, 1974 «ncl subf.pqucnt It ifi ont loioflt.i*d ti;.'it tho Cor.fr itt^o nay achieve its v / i t h i n t v e l v calender nonths. If an txtonsion of tiir.e ic oc'i, t h i s w i l l bo properly negotiated. D. A';?;t:CY PJTICIAL 10 WHG^ Tnr. C'OK/aTTFJf.1 REPORTS : The Corrr.tt tee w i l l report to the thi«9f Hedical Diiectot through t h o AEC i f i t o n t C h i e f .".odicai Kirectoi for Profpr.sionol Service?., V*- 1 f t ami A r f r n i n i f l t t a t ion Dopaitp-icnt of r.^dicinc and C u t c o t y . r. nrr-cRip'rioi; or FH-C The c o m i t t n c h o l d o o u o r t c i l y sosr>lonn at the V c t o t a n s Aclntnist r a t i o n C o n t i f t l Q l i f i r e in accord arc-? v.-ith an fjpptcnt Utt*J r>cJH;<5~ u i ^ of da toe set, at pioCf-rJin'o r,e£t ir,t;3, A K t t u c t u t e c l ar;cnca ic f o l l o w e d . J-^rbcj s a t e aekotJ to prepuce special ptcsontatione �and gather categories of data uniquely accessible to them. Ml members state their views fully and explicitly and support those with documentation as needed. The views of individuals with differlno opinions are recorded. Testimony is obtained from knowledgeable persons. Meetings are open to the public except when, in the discretion of the Chairman, the privacy of individuals, who may cor.e under discussion, nay be infringed. Members of the public may direct questions to the chairman in writing and submit prepared stftensents for review by the committee. At the discretion of the Chairman, ftuch members of the public may be asked to clarify such submitted iTtatetiai prior to consideration by the committee. The committee maintains summary minutes of: its findings and develops conclur, ions and interim reports for consideration by the staff of the Veterans M'iminis tration. The committee maintains liai~ son with a l l other federal agencies which have knowledge of and expertise in toxicology of chemical substances which may be pertinent to the herbicide issue. G. MVT.nCUSillP: MeiT.be rs of the committee include experts delegated by the other federal agencies, non-federal experts including toxicologists and physicians from industry, universities, end chartered veterans groups. Selected staff of the Veterans Administration Central 01. f. ice serve ex officio on the committee. The Chairman is a lexicologist stf.fr member of the Wedical Service. It. ESTIMATED OPRPA.TIFG COSTS: *> " ..... ...... •"" "* """" ""*"" ' .«.«-——— - Dollars: $5000.00 Man days: 300 co" : ; x. t-re r.":t.i£. q :-.L tex lv for cr.£ half day per session. : 0. TKkfllUATICl^ JW'.'iT: (me- year f'roi- the date of the first meeting, unless there is tea son to extend the life of the committee on a quarterly basis, K - - Federal Employees: Others : Volunteers i None Consulting Fees and Expenses per 5 U.S.C". 5703 Service on the committee sana remuneration is acceptable. �L. September 20, 1978. kWROVBO, —'" «* DATE. DATI-' U1/G«rU W. H. Sch^r., M,B,/«* 9/M/78 � 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. 202 Folder The folder containing the original item. 5746 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/. Date A point or period of time associated with an event in the lifecycle of the resource September 20 1978 Title A name given to the resource Charter of New Veterans Administration Advisory Committee ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/a1052311ebbd3473c78be6d081e295aa.pdf 4248ded266190c1db2e485185dd0f9ee PDF Text Text Item D Number 0557 ° D Not Scanned Author Corporate Author Report/Article Title Charter: Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants Journal/Book Title Year 000 ° Month/Day Color Number of Images D ° Descripton Notes Tuesday, March 19, 2002 Page 5570 of 5611 �CHARTER Advisory Committee on Special Studies Relating to The Possible Long-Term Health Effects of Phenoxy Herbicides and' Contaminants Purpose By memorandum of December 11, 1979, the Assistant to the President for Domestic Affairs and Policy directed the establishment of an Interagency Work Group to Study the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants (Work Group) under the leadership of the Secretary of Health and Human. Services. The Work Group was: specifically directed to assure that the protocols, and methodology of proposed Federal research studies will produce reliable data, as well as to provide technical support to individual agencies in. the implementation of research. On August 1, 1980, the Work Group recommended that the United States Air Force conduct its proposed Epidemiologic Study of Ranch Hand Personnel (Ranch Hand Study) and that the conduct of the study be overseen by an independent monitoring committee. By memorandum of September 16, 1980, the Assistant to the President for Domestic Affairs' and Policy directed the•• Air Force to conduct the Ranch Hand Study. In addition, the memorandum directed the Scientific Panel of the Work Group, augmented by scientists from outside the government and including those suggested by veterans organizations-,to oversee the study and to provide -technical assistance, as needed, to the Air Force. Authority 42 U.S.C. 217(a); Section 222 of the Public Health Service Act, as amended. The Committee is established in accordance with and is gbverned by the provisions of PV^L. 92-463 which sets forth ' standards for the formation and use of Advisory Committees. Function The Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants shall advise the Secretary and the Chair of the Work Group concerning its oversight of the conduct of the Ranch Hand Study by the Air Force- and shall provide technical assistance to the Air Force in its conduct of the study. The Advisory Committee shall perform the same functions with respect to its oversight of any other studies in which the Work Group believes involvement by the Advisory Committee is desirable. �Structure The Committee shall consist of the Secretary, or designee, as Chair/, and six members selected by the Secretary from authorities knowledgeable in clinical medicine, medical epidemiology, toxicology, biostatistics and related fields. Members shall be invited to serve for the duration of the • Committee. Management and staff services shall be provided by the Public Health Service. The Office of the General Counsel shall provide an Executive Secretary. Meetings Meetings shall usually be held quarterly at the call of the Chair, who shall also approve the agenda» A government, official shall be present at all meetings* Meetings sha.ll be opea to the public except as determined otherwise by the Secretary; notice of all meetings shall be given to the public. Meetings shall be conducted, and. records of the proceedings kept, as required by applicable laws and Departmental regulations . Compensation Members who are not full-time Federal employees shall be paid at the rate of $100 per day, plus per diem and travel expenses in accordance with Standard Governmental Travel Regulations. Annual Cost Estimate Estimated annual cost for operating the committee, including compensation and travel expenses for members but excluding staff support, is $11,600. Estimate of annual manyears of staff support required is one-half, at .an estimated annual cost of $15,000. Reports An annual report shall be submitted to the Secretary through the General Counsel not later than November 1 of each year, which shall contain as a minimum a list of members and their business addresses, the committee's functions, dates and places of meetings, and a summary of committee activities and recommendations made during the fiscal year. A copy of the report shall be provided to the Department Committee Management Office. �Termination Date Unless renewed by appropriate action prior to its expiration, the Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants will terminate five years from the date this charter is approved. This Committee will be renewed eve'ry two years in compliance with P.L. 92-463, the Federal Advisory Committee Act. Approved: DATE V SECRETARY �THE V; H I T I H O U S E w A s H i .•; G T o N September 16, 1930 MEMORANDUM FOR THE SECRETARY OF.DEFENSE -The Air Force has sought guidance from the Interagency Work Group on the Possible- Long-Term Health Effects of Phenoxy Herbicides and Contaminants on whether it should proceed with the Epidemiclogical Study of Ranch Kane Personnel because the National Academy of Sciences review of the. Air Force protocol had expressed concern about the.credibility of the Air Force to conduct, the study. Ranch Hand personnel, who applied Agent -Orange between 1962 and 1971 in. Vietnam, are the only population whose frequency and duration of exposure to'Agent Orange are known with any accuracy. The Interagency Work Group agrees with the Air Force that the results.of the Ranch Hand study should provide valuable information about the long-term health effects of exposure by veterans to Agent Orange in Vietnam. Over the past. 20 months, the Air Force has made a conscientious effort to design a scientifically 'valid study respcnsiv-e to the recommendations of five separate peer reviews, including' that of the National Academy- of Sciences. After a thorough review of the proposed final study protocol, which includes certain changes based on the separate peer reviews, and'' after consultation with the Air Force scientists responsible for the study, the Work Group recommenced to me that the Air Force be instructed to carry out the Ranch Hand study. In light of the progress already made by the Air Force and the need to proceed expeditiously with this important study, Frank Press and I concur, with the Work Group's recommendation.. There remains deeply felt concern among some Vietnam veterans and others about the objectivity of the Air Force to study the possible health effects of Agent Orange. While affirming • the capability of the Air Force to a-ssure the proper conduct • of the study, the Interagency Work Group has suggested that this concern can be reasonably addressed by independent: review and monitoring of the study. I believe thai the Scientific Panel of the Interagency Work Group, which is already familiar �tne Rancn Hanc protoco^, is tne appropriate cociy to oversee the study and to provide technical assistance, as needed, to the Air Force scientists responsible for the study. For the-purpose of assuring the public that the study 'results are reliable and valid, the Work Group plans CG augment the Scientific Panel with reputable scientists ' from outside the government, including those suggested by veterans organizations. The Interagency Work Group noted that the evaluation of "Ranch Hand personnel may have to continue for a lengthy period of time in order to have a better chance of detecting latent or subtle health effects, particularly related to cancer. The'Air Force, in consultation with the Scientific Panel,, has already designed the protocol to reflect this recommendation. I am advised, that the- Ranch Kane study presents a nuinber of difficult technical problems. While recognizing the need, to obtain study results promptly, the Air Force's primary responsibility must be to assure that the'results will be reliable, and valid. I,urge the Air Force to utilize fully the expertise of the Scientific Panel of the Interagency Work Group to advise them on the difficult decisions, that will surely arise during the course of the study. - In closing, I- would like to reaffirm the importance of the Ranch Hand, study to Vietnam veterans and their families. The Interaaency Work Group and the White House are prepared to offer any assistance that the Air Force-may require in discharging its responsibility to conduct a high quality scientific investigation. Stuart S. ££izer.stat Assistant to the. President for Domestic Affairs and Policv �PLAN FOR APPROPRIATE BALANCE OF COMMITTEE MEMBERSHIP The membership of the Advisory Committee on Special Studies Relating to the Possible- Long-Term Health Effects of Phenoxy Herbicides and Contaminants shall be selected from authorities knowledgeable in toxicology, medical epidemiology, bio-statistics, clinical medicine and related fields. The Department will give close attention to equitable geographic distribution and to minority, female and youth representation. The Secretary will make the appointments without discrimination on the basis of age, race, sex, cultural, religious or socioeconomic status. � 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. 198 Folder The folder containing the original item. 5570 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/. Title A name given to the resource Charter: Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants 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. 182 Folder The folder containing the original item. 5305 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 January 9 1980 Title A name given to the resource Chemical Companies Charge Government Misused Agent Orange ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/275a1f49f7c80beedcc0cd2c68b09c01.pdf e89f4b65ea59039880296f174f6c5cf3 PDF Text Text Item D Number 05168 D Author Corporate Author Report/Article Title Chemical-Biological Warfare: U. S. Policies and International Effects: Hearings before the Subcommittee on National Security Policy and Scientific Developments of the Committee on Foreign Affairs, House of Representatives, Ninety-First Congress, First Session Journal/Book Title Year 1969 Month/Day November/December Color D Number of Images ° November 18, 20; December 2, 9, 18, and 19, 1969. Friday, March 01, 2002 Page 5168 of 5263 �05. POLICIES ..AND INTERNATIONAL EFFECTS *; ' :. '.; .... * ' ' . ' V ,-'-••:• . '- , >'<IA *"* . ' HEARINGS ;- ^ ." * • ** t . i ' ; T'' A' i -'• /•! -' •'• •.''*•' '* • -< • ,',.. • '•" ,v V 1 ; . .^.;.» .'V :>''V"'! v - •>>:-: I ;,, ICDEYEIXJPMENTS^a^'l " OF " ' . . . M;;>;'fe'--- ' ' ...- w^ «B9K;.^^1/: ,,;r^^:;.^'!l| •-•'• /' .V^V^ • - ' -".:^^,^^ - .- -, * '*.,-; . . ". /«OVBMBBR18,»;WBOTlIBBBti,i*iin)^«e» " '^- �228 of the downed men. This protects the well us the downed airmen from aimed wearing protective masks then extracts are many documented examples of such ivscne crew and aircraft as enemy lire. The rescue team the downed crewmen. There successful operations. srSIMAKV The riot control agent, CS, has liccomc n lifesaving part of military o|H>nitions in Vietnam. C\, the older agent, IKVHUSC of its relative ineffectiveness, is now seldom used. The use of CS in combat ojorations clearly reduces casualties among friendly troops, permits extraction of civilians who mav be under enemy control often without casualties, and frequently allows the enemy the option of capture rather t h a n casualties. Perhaps the most valid indication of the effectiveness of CS in combat operations is that U.S. ]>ersonnel continue to carry ('S grenades to the Held in lieu of some of their normal high explosive ammunition, and ground commanders often call for CS rather than high explosives. ]{iot control agents arc a valuable aid in accomplishing our mission and in protecting our forces. IIKRIUCIUK.K Turning now to the use of herbicides in Vietnam, one of the mosr difficult problems of military oj>erationri in South Vietnam is the inability to observe the ene.my in the dense forest and jungle. Defoliating herbicides introduced in l!Mi:i are capable of producing n significa,nt improvement in vertical and horizontal visibility in the ty]>e of jungle, found in South Vietnam. As viewed by an aerial < observer, it. is often ini]K>ssihlc to see through the canopy to detect ^"(' or XVA o|»erationp. In (> to > we»>k>, a f t e r spraying with a herbicide, the observer will have jjood observation throujrh the canopy. rFor ground obser\-ation. defoliation is highly elfe<'tive in impro\"iii^ horixontal visibility. The herbicide program in terms of effects produced has required an unusually small investment of military effort. The entire program has |K*'II accompli shed with an average of alx>ut 17 C-1'23 spray aircraft and several smaller helicopter sprayers plus some improvised "round-spray equipment. Herbicide, operations are conducted under a program directed by the Government of South Vietnam. Keqncsts for these operations <renerally originate at the district or provincial level and are submitted through territorial administration command channels. The herbicide spray plan, includes as a m i n i m u m the area requested to l>e treated with herbicide, the public information, civil affairs, and intelligence annexes, along with a statement by the province chief tiiat he will see that just and legal claims are paid for any accidental damage. The ARVX corps commanders and their U.S. corps senior advisers have been delegated authority to approve small scale defoliation by groundbased spray and by helicopters. All requests for crop destruction and larger scale defoliation by T-12:? aircraft are forwarded to the Vietnamese. Joint (Jeneral Staff. Upon approval of the request by the. Chief of Joint General Staff it is forwarded to the MACV staff for final review. �The M A t ' V ;-f:ti! po>iiion is developed as the result of coordination with ('OKI'S (Civil Operations and Revolutionary Development Support). 1'>A1D. and political representatives at each level where they exisl. An aerial reconnaissance is conducted as the next step to insure that all populated areas and friendly crops have been excluded from the, target ami. Having determined from this aerial survev and an aiuilvsii- "! i!i»' military worth that the project is a valid herbicide target, 'the pi->i*vt is forwarded to the tl.S. Amhassador and ( O.M1 "S.MA( V for ajiproval. The Ambassador personally approves all C-}-2'-\ d e f o l i a t i o n projects and all enemy crop destruction projects. " O M K SIT.ril-MC I SKS OK IIKUIIICHIKS Some s|>e< me MM'- of hei'hici«les are : /. /ti'fu/nltir-" n ' tulxi fll'rulK'tl'I'K A portion of t h e -mall-scale ground ha«ed or the helicopter spray mi-sioiis ar* 1 'j'Ctl in improving the defense of base camps and fire bases, llei-birdie- aiv a great help in keeping down the growth of high jungle .LTV:;—. bu>hes, and weeds which will prow in cleared areas near these camp-. This clearance opens fields of tire and affords observ a t i o n for oiui'o-ts to prevent surprise a t t a c k and as such is truly a life-sax ing mea-urc for our forces and our allies. Without the use of herbicide- around our lire bases, adequate defense is difficult and ill many pla«v* impossible. '. Jtl fltl'ilhi//' n ' :nn > t>l i-ii/ii/jillllli'il/lltll 'I here are m a n y inMances of ambush sites lx?ing defoliated for bi'ltcr acriiil "ii~ri-> MI ion and inipi-oved visibility along roads and trails. I n l i n - 7 t l i c i - . - \\ere also many requests for defoliation of VC tax collection | , o . i i f - , . I n otherwise friendly territory theiv were points alonjr w e l l - t ] - a \ I'lrd routes where the enemy could hide under cover and inteivepi i r a u ' l e i x to demand taxes. Defoliation along these roads \\ a< very effect \\\- in opening these areas so that they can be seen from observation a i r - r a f t , and w i t h few exceptions these roads were opened ro free t r a v e l . Tin 1 n-e of aircraft, to spray alongside lines of communication proved valuable in clearing these areas and preventing costly a m l i n - h of a r m y convoys with resulting friendly casualties. 3. 1'tcftiHiitii,,, i,< 'nti!>fii!ioii r<ni/<'>-' Areas used b\ t ; i c enemy for routes of approach, resupply or ino\ - ement are target^ for herbicide spray. 1'robably the most valuable use of herbii-ide-s for d e f o l i a t i o n i s t o ] > e r m i t aerial observation in such areas. TJiis is puiri' !i];:riy (rue in areas near the border so t h a t we can detect movement of rii'-my u n i t s and t h e i r resupply. !). ])cit>l'i<ttmn <•/' < in a, i/ IHIXI' fitmfix We. know fi-oin pi-isoners of war and from observation that the enemy w i l l mo\v from areas t h a t have lx>en sprayed. Therefore, enemy base camp* or mot headquarters are sprayed in order to mnke him move to m o i d exposing himself to aerial observation. If he does move back in w h i l e '!."' area is s t i l l defoliated, lie w i l l be ol(served and can be engagt'd. �230 5. Crop destruction Ci-ops in areas remote from the friendly population and known to belong to the enemy and which cannot bo captured by ground operations are sometimes sprayed. Such targets are carefully selected so as to attack only those crops known to be grown by or from the VC or NYA. The authorization to attack crops in specific areas has been made by the U.S. Embassy, Saigon, MACV and South Vietnamese Government. Frequent reviews have been conducted of the herbicide program. Tlip most recent one was personally directed and reviewed by COMUSMACV in October 1968 to assure himself that the program was militarily effective. Prior to that, the U.S. Ambassador had directed a review which looked at the political and economic aspects of the program. The Embassy report was released in August 1968. The crop destruction program was also received by the CINCPAC scientific adviser in December 1967. Each of these reports concluded that the progium should be continued. Mr. ZABLOCKI. At this point, will you supply the Embassy report and the OINCPAC scientific advisor report for the fiscal year 1967 if you have it? Admiral LEMOS. I do not have them with me, but I will supply them. (The reports, which are classified, were provided to the subcommittee for its records.) The requests for defoliation and crop destruction have always exceeded our capability to spray. The requirement continues although a tapering off should develop if enemy activity subsides. A recent review by MACV indicated that operations for 1970 will be less than in 1969. In addition, Rome plows are replacing defoliation for clearing along many lines of communication. THE USE OF 2,4.r>-T IN VIETNAM With regard to the recent publicity of the herbicide agent, 2,4,5-T, which is a component of orange, a herbicide mixture, the bionetics research laboratories conducted a study of the carcinogenic, teratogenic and mutagenic activity of selected pesticides and industrial chemicals for the National Cancer Institute during the period 1965-1968. The studv indicated that a largo dose of 2,4,5-T administered orally to specific strains of mice during the central portion of the gestation period produced abnormal fetuses. However, on October 29,1969, Dr. DuBridge, science advisor to the President, stated, "It seems improbable that any person could receive harmful amounts of this chemical from any of the existing uses of 2,4.5-T." Nevertheless, Deputy Secretary of Defense David Packard has issued instructions to the Joint Chiefs of Staff to reemphasize the already existing policy that 2,4,5-T be utilized only in areas remote from population. When the American Embassy conducted the political economic review of the herbicide program, it requested that a disinterested expert be sent from the United States to assess any ecological consequences of the program. Dr. Fred Tschirley, Agricultural Research Service, �231 Department of Agriculture, was sent over in March 1968 for a 1-nionth period. Arrangements wore made which permitted him to fly over any area of Vietnam he wished to inspect plus on-the-ground visits to any safe area. Ho concluded that the defoliation program had caused some ecological changes. Although single treatment on semideciduous forest would cause iiK-onseguential changes, repeated treatments could kill enough trees to permit invasion of many sites by bamboo. The presence of bamboo would then retard regeneration of the forest. The Army supports the need for a more detailed investigation of the ecological effects of herbicides used in Vietnam. Such im investigation should bo conducted in coordination with other interested agencies. In being hostilities phase. EXAMPLES OF DEFOLIATION SUCCESS IN VIETNAM In the final analysis the sole purpose of the herbicide program is to protect friendly forces and conserve manpower. The following examples should demonstrate the success of the defoliation effort in Vietnam: 1. Major defoliation has been accomplished in war zone C. Prior to defoliation, seven brigades were necessary to maintain U.S./GVN presence. During 1%7, after defoliation only three brigade; were required. '2. The commander of naval forces in Vietnam in a report to General Abrams stated— As you know, a major ooucern is the vegetation along the main shipping ehininel. Your continuing efforts under difficult and hazardous flying conditions, in keeping this area and the adjacent inland areas devoid of vegetation have contributed considerably in denying the protective cover from which to ninbush the slow-moving merchant ships and U.S. Navy craft. 3. In 1968, the commanding general of the 1st Field Force reported— Defoliation has been effective in enhancing the success of allied combat operation*. Herbicide operations using C-12.H aircraft, helicopters, truck mounted and hand sprayers have become un integral part of the II CTZ operations against VC/NVA. The operations are normally limited to areas under VC/NVA control remote from population centers. The defoliation program has resulted in the reduction of enemy concealment and permitted increased use of supply routes by friendly unit*. Aerial surveillance of enemy areas has Improved and less *«>curlt'y forces are required to control areas of responsibility. An overall result of the herbicide program 1ms been to increase friendly security and to assist in returning civilians to QVN control. 4. The U.S. commander in the III CTZ related: Herbicide operations have contributed significantly to allied combat operations In the III Corps. Defoliation is an important adjunct to target acquisition. Aerial photographs cau often be taken from which interpreters can "see the ground" in areas that previously were obscured. Defoliation also aids visual reconnaissance. U.S. Air Force FAC's (forward air controllers) and U.S. Army aerial observers have discovered entire VC base camps in defoliated ureas thnt had previously been overlooked. 5. In the south in the IV CTZ, C-123 herbicide operations are limited. This is because of the vast areas of valuable crops which are not to lie destroyed, even though they may be in enemy hands. There- �232 fotv, the commander of the I V Corps area in presentinir his cvahiiition cited tlu>, value of helicopter operations as follows— A significant helicopter defoliation mission was conducted in 'lie vicinity of S A I » K < ! in August IIHIS. Tin- target area consisted of three ;u;iin canals which converged and formed a strong VC base. The dense, vegetation permitted viability of only ]ft-in meters horizontally and nil vertically. Tin1 area was sprayed with approximately "•".."> gallons of herbicide white and over 'HI percent of Hie !ire:i V M S defoliated. As Hie result of the defolintion. an A K V N l i n i t n l i i n i Mas able to remain overnight in I lie area for the first time iu ."> yi»jir« Many enemy hnnk'Ts were open to observation. Since the defoliation, the VC presence hii-decreased to the point that only UF/1'K forces are now i.e.v-ary for local security. (i. As a part of (lit 1 1!K'»S evaluation report of her'>i.-idf operation*., the. 1T.S. senior adviser in the IV ('orps tactical /one .-HIM reported— A section of Nntiomil Highway 4 in 1'hong Pinh 1'rovince v > . i - the site for a defoliation o)K>ration on June 'J4. T.KiS. Since .lauuary ]!MN. :> »,>rii's of iiiiibusli"< wns conducted against SVN convoys and troop movement*. B-v> :iu-e of the total Inability of ground troojis to ket-p the area clear of VC. thN .-ir.'a was sprayed lining 8W gallons of herbicide while. The target area was primarily coconut piilni and banana trees that had been abandoned by their owneri for several years. 1 luring the period of abandonment the vegetation had liec.mie so dense that convoy security elements were not nble to wee more than r, meters Into the underbrush and had to rely on reconnaissance by fire to dix'ovi-r the hidden enemy. This method of protection had proven Ineffective. Three HK/I'F companies with I'.S. advisers were used to secure the target for :!it» helicopter operation in addition to an armored cavalry troop. Since the det'oliari.ni mission was completed, convoys have used the highway two or three times a week without attack or harassment. Only one RP plat<»on 1ms remained ia tli>- area to provide local security to the hamlet and highway. 7. In certain iiir-lanci's, we know the VI 1 have IHVI-. I'mvctl to divert tactical units from combat missions to food-piwmviuiMit operation? and food-transportation tasks, attesting to the ertVtivencss of the crop destruction program. In local areas where extensive crop destruction missions were conducted, VC/NVA defections to GVX increased as a result of low morale resulting p r i n c i p a l l y from food shortages. The most highly valued item of equipment to tield nmmanders in Vietnam is the helicopter. There was some question when the helicopter spray equipment was first procured whether tield commander? would divert the use, of helicopters from combat operations for herbicide spray operations. The very fact that the commanders have used their helicopter spray equipment to the fullest and have asked for more is certainly proof that herbicide oix'ratious h.ive been helpful in protecting the, American soldier ami contributing to successful accomplishment of the ground combat mission. roxn.vsiox Gentlemen, we have presented to you in as complete rind candid a manner as possible the lifesavin«r usage that we have made of riot control agents and herbicides in South Vietnam and the policies under which this usage has taken place. We believe this usa^e has been wise and has been accomplished with restraint. The result is that our forces have been better able to accomplish their mission v / i t h Hgnilicantly reduced U.S. and Viet namese casualties. �233 ADVERSE EFFECTS (IK J IKRlllClDK I'SK'. OAMACE CLAIMS Mr. XAHI.OCKI. Thank you for your statement, Admiral Lemos. You have outlined the list's and the benefits of chemical agents in Vietnam. Certainly there, must be adverse political and economic, results Ix'cunso of the use of herbicides and tear gases like CS. Jlsive there not been instances of the misuse of herbicides and tear ga>? Could yon give a view of those for the record of the subcommittee '. For example, I understand Cambodia has a suit against the United States for damage done because of the use, of herbicides. It is also my understanding some South Vietnamese are going to seek damages because of loss of income or loss of property. I understand banana plantat ions have l>cen destroyed. That, would indie-ate then; are uses of chemicals which have been adverse to our interests. Admiral LEMOS. There have been some such instances. Mr. ZAIJLOCKI. Could you tell the committee ulioiit how many? You have given all the good side of it. I wouldn't expect yon to dwell at length on the reasons why chemicals should not have been used, or where errors were committed, but I think in fairness you ought to tell us a little bit of both sides. Admiral LEMOS. There have been some few instances and these have been very carefully explored in the reviews that I have mentioned and mute clearly from the results of the reviews it has l>een determined that in the overall context, the disadvantages and the few abuses were very greatly outweighed by the very real advantages provided to our forces and to the, Vietnamese Forces and the very real difficulties they provided the VC and North Vietnamese Forces. With respect to the Cambodian incident, this was a border incident. As yon know, sir, there are stretches of the Viefnamese-Cambodian border that are under dispute. They are not clearly marked in any way. In situations such as this where you know there are, enemy base camps, enemy forces operating in the jungle, and from which heavylire may be coming, spray operations close to the border have been conducted. It would appear that in one of these cases either the spray plane was in an area that was in dispute or was not clearly marked and this situation was reviewed and as I understand it observers were sent to the area and a report has been prepared. Whether that report has been yet released, 1 do not know. I have not seen it. HOW CLAIMS AUK PROCESSED AXI) PAID Mr. ZABLOCKI. In your testimony, Admiral, you say that the province, chiefs supply the basic intelligence as to what areas herbicides should be used in. Admiral LEMOS. Yes. Mr. ZARI.OCKI. Realizing the political problems Iwtween Caml>odia und South Vietnam, could this have entered into the, selection of the defoliation of areas along the lx>rder of Cambodia? Admiral LEMOS. I am certain it has. As 1 have indicated, all C-12" spray operations must have the clearance of the (rovernment of Viet- �234 nam, of COMTTSMACV and of the Ambassador. All three must approve C-123 operations. Mr. ZABLOCKI. You also stated that the province chief must state that he will see that just and legal claims are paid for any accidental damage. Where is he going to get the money? Admiral LEMOS. To the extent there are damages—-— Mr. ZABLOCKI. From my knowledge of the South Vietnamese anything they have is received from us. Admiral LEMOS. We do provide substantial support to the South Vietnamese. The payments, however, are made by the Government of Vietnam. Mr. ZABLOCKI. But we pick up the tab? Admiral LEMOS. Not entirely. Mr. ZABLOCKI. Could you advise the Congress if we ultimately are going to have war damage claims like we had in the Philippines because of the damage to crops and industry? Do you anticipate there will be such war damage claims? Admiral LEMOS. I am not able to anticipate that kind of claim. Mr. ZABLOCKI. In view of the fact that we were the defoliator and, our U.S. Ambassador has been consulted and must give the order for the use of herbicides, wouldn't it be logical that South Vietnamese owners of plantations will be filing claims through the U.S. Embassy the first opportunity they have ? . Admiral LEMOS. Thev have that opportunity now, sir. Mr. ZABijOCKi. And they are doing so ? Admiral LEMOS. J presume Mr. ZABLOCKI. And when hostilities end we will have millions of dollars in claims thrown at us. Has this been taken into consideration by Defense Department when the decision was made to use herbicides ? Admiral LEMOS. I am certain it was taken into consideration. Part of the reason for the reviews was to consider specifically these points. INTEL1JGENCE ON AREAS DEFOLIATED Mr. ZART-OCKI. In outlining the elaborate procedures which you have taken in the use of herbicides, in the past, we were impressed—certainly I was—with the lack of accurate ana hard intelligence in the Vieteonpheld areas. How sure can the military be that fields that are selected by the Vietnamese province chiefs are in Vietcong-held areas, and how can the province chief know for sure that the crop is going to feed Vietcong soldiers? If we have such excellent intelligence where their Vietcong rice fields are, we should have better intelligence in other areas. Admiral LEMOS. Intelligence is improving daily, as we move out in the countryside and get more and more hamlets and villages under the control of the Government of Vietnam and more and more people willing to risk their lives to give information that points out where the Vietcong are and where it is difficult to go. DOD DECISION ON 2,4,B-T Mr. ZABLOCKI. On page 14, you said that the Deputy Secretary of Defense, David Packard, has issued instructions to the Joint Chiefs �235 of Staff to reemphosize the already existing policy that 2,4,5-T shall be used in areas remote from population. I thought there was a decision not to employ 2,4,5-T in the future. Admiral LEMOS. I am told there is no such decision. ' Mr. ZABLOCKI. The use of 2,4,5-T is however, under review. On page 15 you say a review of the ecological effects of the military use of herbicides is now being initiated. Admiral LEMOS. Yes. sir, that is the whole herbicide program and the ecological effects of all herbicides. Mr. ZABLOCKI. 2,4,5-T, it is my understanding, is the most potentially dangerous to people, resulting hi the greatest political problems. Is that not a fact? Admiral LEMOS. That is my understanding, yes, sir. DOD HERBICIDE STUDY Mr. ZABLOCKI. The herbicide investigation project that you referred to on page 15, could you give the subcommittee more details on this project? It will be conducted by the Department of Defease or contracted out? Admiral LEMOS. Initially in-house and then go on contract. Mr. ZABLOCKI. Wouldnx it be preferable to reverse the order and have some uninvolved group study the ecological effects of the military use of herbicides in Vietnam, and then have the military review the report? Admiral LT.MOS. Mr. Hnyward yon have any comment on that? Mr. ZABLOCKI. Wouldn't that be advisable ? STATEMENT OF ALBERT E. HAYWARD, ASSISTANT DIRECTOR, CHEMICAL TECHNOLOGY, DEFENSE RESEARCH AND ENGINEERING, DEPARTMENT OF DEFENSE Mr. HAYWARD. Mr. Chairman, some time ago in our discussions with the American Association for the Advancement of Science, the Department of Defense agreed in principle that this type of survey should be done, and we have every intention of inviting this association, and also of inviting the National Academy of Sciences and other scientific groups, if they would participate in this survey. The project which Admiral Lemos referred to is being started or initiated now. I believe that our activities during the remainder of this fiscal year will be largely in planning and in reviewing the things that have been done. I can assure you that uninvolved scientific bodies will be invited to participate in this. Mr. ZABLOCKI. At a later date. Mr. HAYWARD. Within the next few months. They should be involved in the planning as well as the discussion, sir. So it will be done within a reasonably snort time period. Mr. ZABLOCKI. Some are hopeful that by then it may be a moot question. I have a call, will you excuse me ? Mr. Fraser . . . Admiral LEMOS. Surely. -70 10 �253 all circumstances to live up to the Geneva Convention if it didn't prove convenient, satisfactory, or necessary ? Admiral LKMOS. All I can say is that all of the. efforts against North Vietnam, including our planning of it, were subjected to the very highest review in all responsible agencies of the Government. I cannot conceive of the approval of plans in direct violation of that convention. Mr. FULTON. But you also said, when I brought up the word "consideration," that there may have l>een alternative plans under consideration although not used for the. bombing of North Vietnam dikes that are for the main purpose of food production. Admiral LF.MOS. Mr. Forman correctly analyzed my problem when he said I misinterpreted what you are saying. There are a number of dams in North Vietnam not directly related to the problem you propose. Mr. FULTON. We are really trying here to get the basis for the policy that is in effect and the limitations on the policy under international law. So my question is based really on finding out whether the policy just "growed" like Topsy or it was an express lilting the policy in, the U.S. military, under the Geneva Convention. That is all, Mr. Chairman. Admiral LEMOS. I don't know how to answer that question except to say that (he military do not of themselves do things in violation of U.S. policy. Mr. FULTON. No, I agree with you thoroughly, but that's the other side of (he coin. I am saying, how did we in the United States as a military decision, arrive at this particular policy? How was the policy arrived at? Admiral LF.MOS. The policy not to bomb ? Mr. FULTON. The dikes of North Vietnam that have to do with food production? Admiral LEMOS. I am very certain it was arrived at on the basis of consideration of this convention. Mr. FFI.TOX. So then there were, no plans ever us an alternative, by the U.$. military, even considered for the bombing of dikes of North Vietnam that are used primarily for food production ? Admiral LF.MOS. In my capacity I can say clearly that I am unaware of any such plans Mr. FULTON. May we have (he information supplied for the record, Mr. Chairman? Mr. ZAULOCKI. Very well. (The information follows:) Quention. ffistorji of plan* for Vomiting of dnnin in Kortli Vietnam ax an anticroi> operation f Answer. (Statement for record). The Department of Defense policy Is not to fllvuljre drtnils of military plans. A , ,i HOW MANY DETOLIATTON CLAIMS? Mr. ZAIILOCKI. I would like to clarify something. On page 10, Admiral, you list the procedure under which herbicide spray is used. T refer again to the payment of legal claims. "The province chief will sec that claims are paid for unjust and illegal damage." �254 I nni not sure, when you answered my question wirlier, you understood what J meant /<> ask. On whose behalf was he making >hat pledge? His Government? Our Government? Admiral LKMOS. His Government. Mr. ZAIIUM-KI. T believe I did ask whether you would supply for the record, Admiral, how many claims have l>cen made. Admiral LKMOS. I don't'recall. Air. ZA»I,OCKI. And what will be the procedure for paying them? I tun personally satisfied that if the claims are made to the province chief he will somehow pot it to the Saigon Government, and they will pet to the tLS. Government and we will be picking 1 up the tab. Please supply for the. cximmittee this particular answer. It may be a very controversial issue some day. Admiral LKMOS. Yes, sir. (The information follows:) Question. Jivmltrr of claim* submitted for damage from herbicide and crop damagct Procedure* lor paying these claimsT Answer (statement for record). The US Foreign Claims Commission in RVN has received 41) claims from residents of the RVN in the nmouiit of $6G,81C (US dollars) for herbicide damages. The 43 claims adjudicated so far have been denied cither hwaiisc such diiningc wan combat related or <l,>iiiinge observe*! was not caused by dcfolianls. Claims ugainst the US Government may be payable for certain accidental defoliation damage resulting from u spray aircraft mishap. Herbicide claims from Vietnamese and foreign nationals residing in the RVN are normally made against the GVN and are handled in GVN channels. Prior to the initiation of herbicide operations, the respective GVN province chief requests such o|>erations and pledges indemnification for accidental damage to croi»s and trees of friendly citizens. Procedures require that such claims be initiated at District level and processed to Province headquarters for adjudication up to an amount of 100,000 piasters. (One US dollar equals 118 plasters). Claims of an amount greater thnn 100,000 piasters are processed to Headquarters, Joint General Stuff and the Ministry of I>efense for adjudication on a case by case basis. Maximum compensation payment is 500,000 piasters. The GVN programs handle the great bulk of crop damage claims in RVN'; however, if a local national insists on filing a claim against the United States because of defoliation damages to his projierty. his claim is accepted and investigated. The claim and report of investigation are referred to a US Foreign Claims Commission appointed by COMUSMACV for adjudication under the authority of the Foreign Claims Act, 10 USC 2734 and PL 00-521. Since the defoliation claims program is being kept in GVN channels and an active claims program is being kept in operation by the. GVN, an influx of compensable claims against the US Government generated by the potential termination of hostilities is not expected. Mr. ZABLOOKI. If there are no further questions, on behalf of myself and the entire snlx'-ommittee, Admiral, I want to thank you for your excellent, presentation and for the direct answers you have given to the questions that were asked of you. In view of the fact that certain matters are classified which you will supply to the committee for the record, I see no reason to go into executive session. Therefore, this concludes the hearings of the sul>c.ommittee on the international aspects of chemical-biological warfare. The subcommittee will stand adjourned until further notice. Thankjou, Admiral. (Whereupon, at 12:35 p.m., the subcommittee was adjourned until further notice.) � 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. 176 Folder The folder containing the original item. 5168 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 November/December 1969 Title A name given to the resource Chemical-Biological Warfare: U. S. Policies and International Effects: Hearings before the Subcommittee on National Security Policy and Scientific Developments of the Committee on Foreign Affairs, House of Representatives, Ninety-First Congress, First S ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/19be58d7228c34820e124375ae9cd031.pdf 9c1dee5882ebf49e71d1a30c54c9fb47 PDF Text Text Item D Number °5742 U |fot scanned Author Corporate Author Report/Article Title Chronology of Changes in the Agent Orange Study Journal/Book Title Year 000 ° Month/Day Color Number of Images n o Descrlpton Notes Tuesday, March 26,2002 Page 5742 of 5743 �January 1985 23 Battalions tracked. Report to Office of Technology Assessment shows changes Four major changes: a. Battalions rather than companies to be used. b. Ranking of unit exposure likelyhood will not determine selection of men. v» c. Personnel Records and Morning Reports will be used to verify vets period of service. d. Infantry - Artillery units only. March 1985 Three modifications: a. New coding. b. More location recording. c. Reabstract battalion H, 27, 28 March 1985 Now use gazeteer and maps. 18 November 1985 Interim Report number 2 CDC proposed more changes: a. Reviewing 6,000 201 Files will increase to 8,670. At a subsequent meeting on 20 November 1985 figures changed to 6,600. b. Will require additional tracking time periods (1966 and 1969). c. Will eliminate approximately 70% of vets already qualified. 21 November 1985 40 Battalions tracked. �CHRONOLOGY OF CHANGES IN THE AGENT ORANGE STUDY January 1983 Transfer of study to Centers for Disease Control (CDC). February 1983 Assisted with military input to the original protocol. * June 1983 - Jan 1984 ESG pilot study of 10 companies. 16 November 1983 Identified 122 Combat Battalions and Combat Support units. Initiated Vietnam Experience Study. - completed April 1985. 18 M~"ember 1983 50 Battalions now required. 1400 individuals per month. 13 January Initiation of ESG support for CDC Agent Orange Study. Automation delay in arrival of CDC PCs. Constant changes in the rules for use of worksheets. 1984 01 February 1984 Extract all coordinate and locations/- 15 June 1984 Did away with KAYPROS and back to manual mode. 24 July 1984 Telecon about most recent version of time table which now moves up ESG time schedule. 26 July 1984 14 point ESG briefing paper raises questions about procedures. 08 November 1984 20_ Battalions tracked. 09 November 1984 Major changes to protocol given to ESG. 21 December 1984 Major changes to protocol given to ESG. The requirement for 50 Battalion increased to 65. Shorter time lines. Quality Control Plan implemented 11 months into study. • Personnel Data Abstractions increased from 1433 subjects to 2500 per month. Original protocol called for 26 data elements. Vietnam Experience change to 73 data elements. Agent Orange - 143 Data Elements. Back page added, which required additional research. � 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. 202 Folder The folder containing the original item. 5742 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/. Title A name given to the resource Chronology of Changes in the Agent Orange Study 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. 206 Folder The folder containing the original item. 5791 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/. Creator An entity primarily responsible for making the resource Earley, Pete Source A related resource from which the described resource is derived The Washington Post Date A point or period of time associated with an event in the lifecycle of the resource March 21 1983 Title A name given to the resource Clipping: At Work: VA Medical Director Has Cabinet-Size Job 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. 5543 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 Daschle, Tom Title A name given to the resource Clipping: Deaf Ear Turned to Pleas of Veterans Exposed to Dioxin 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. 5436 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 New York Times Date A point or period of time associated with an event in the lifecycle of the resource October 14 1983 Title A name given to the resource Clipping: Judge Withdraws From Suits Over 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. 193 Folder The folder containing the original item. 5453 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/. Title A name given to the resource Clippings on Agent Orange Litigation and other Toxic Tort Litigation, 1983-1986 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. 191 Folder The folder containing the original item. 5394 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 Clippings, transcripts, newsletter and various affidavits, accompanied by a letter from Harvey L. Morrison of McInnes, Cooper and Robertson to Alvin L. Young, dated March 3, 1983 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. 5676 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/. Title A name given to the resource Clippings: Newspaper articles on possible health effects of Agent Orange, April 1986 ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/7df95e1b7568e293edaeb5c4c6aaed93.pdf 6bccf53572138d122746c0bb2f12325b PDF Text Text Item D Number °5819 D Not Scanned Author New JerseV Agent Orange Commission Report/Article Title JOlimal/BOOk TRIO Commander's / President's Update on Agent Orange Year 1984 Month/Day March Color Number of Images D 4 Fu " Newsletter Issue Tuesday, April 02, 2002 Page 5819 of 5840 �UP DATE ON NEW JERSEY AGENT ORANGE COMMISSION AGENT ORANGE VOL. 3 - No. March 1984 Issue From the Executive Director: Wayne P. Wilson Throughout the many months of tracking HR 1961, we have had numerous occasions to touch base with members of the New Jersey Congressional delegation. They were responsive and informed. Sometimes when it is all over and done, we forget to say Thank You. Well, to the fourteen members of the New Jersey Congressional delegation, we say ^ THANK YOU ^ James J, Florio William J. Hughes Robert Toracelli Peter W. Rodino, Jr. James J. Howard Chris Smith Joseph G. Minish Matthew J. Rinaldo Edwin B. Forsythe Marge Roukema , Robert A. Roe James A. Courter Frank J, Guarini Bernard J. Dwyer Commission Phone Numbers (609) 984-7396 (609) 984-7397 (609) 292-1443 answering machine �USE SAYS YEA ON AO As many of you may know by now, the House of Representatives voted in favor of HR 1961, the Agent Orange Presumptive Bill. The House action, by a voice vote, came on January 30th and now puts the spotlight on the Senate, A Bill:similar to HR 1961 was introduced by Senator Cranston of California on July 20, 1983 and is awaiting action by the Senate Committee on Veterans Affairs. The Bill number is S 1651:. New Jersey Senator Lautenbergihasprovided us with a copy of the Bill ;and indicated his strong support of 1651. New Jersey's other Senator, Bill Bradley, has also been an advocate of Agent Orange legislation and we are fortunate to have that kind of strong support from our two legislators. Our office will gladly provide a copy of S 1651, just drqp/us a note. We would encourage letters of support for S 1651 and they may be mailed to: The Honorable Alan K. Simpson, U.S. Senator Chairman - Committee on Veterans Affairs 414 Russell Building Washington, B.C> 20510 Newark VA Vet Center - Their new address is: '•-_.' : ,75 Halsey Street^ Newark, New Jersey 07101 •- - Phone Number: (201) 622-6940 New Team Lead_er is Mr. Horace Br_acy.._ The Jersey City: VA Vet Center'has a new- Team Leader. Her name is Ann Talnage^-Clark. The Vet Center address is still: •626 Newark Ave^nue Jersey City^ New Jersey 07306 Phone Number; (201) 656-6986 Changes in Agent Orange scheduling at VA Facilities: Philadelphia Outpatient Clinic -Monday and Friday only in the a.m. New Scheduling Number - (215) 597-7674 Lyons VA Hospital takes walk-in Agent Orange exaps only. No scheduled appointments. / : �IN THE NOT SO GOOD CATEGORY ... The Veterans Administrations' lack of communication with the membership of their own VA Advisory Committee on Herbicides. Several Members of the Committee have commented that the only time they hear from VA Central Office is to review the transcript of the previous meeting for errors and a notice telling them the date of the next meeting. That's not-so-good! A Vietnam Veteran VA employee was "docked" one hour siek leave in order to take an Agent Orange Screening exam. Apparently, those running the Outpatient Clinic in Florida where this occurred chose to ignore the February 1983 Memorandum from VA Administrator Harry N. Walters. In the memo, Mr. Walters stressed th need "to deal sensitively and compassionately with the deeply felt concerns of Veterans". It would probably be fair to assume that Mr. Walters meant for that same sensitivity and compassion to be extended to Vietnam Veterans employees of the Agency. It's not-so-good to cross the big boss and it's not-so-good for the Vietnam Veteran. Lastly, in the "not-so-good" category is the VA's newest Agent Orange film. The Veteran organizations members of the VA's Advisory Committee on Herbicides were promised they would get to see the film before final editing and release. It's not-so-good to break promises (which the VA)did because now a lot of folks don't likethe VA film and want it sent to the dusty shelf. IN THE REAL GOOD CATEGORY . . . During recent visits to New Jersey by VFW National Commander-in-Chief Clifford Olson and Sr. Vice Commander Billy Ray Cameron, the issue of Agent Orange was discussed on numerous occasions. Both leaders knew the issues, addressed them and voiced the strong, position their organization is taking on the issue. Just before, the National Officers came into New Jersey, State VFW officers .spent, a day visiting the Trenton VA Vet Center. It's real good to see .that kind of committment < It'8 real good to say Thank You to some deserving folks, so here goes: Thank You Vietnam Veterans of Central Florida. Thank You Senator Dalton and Senator Van Wagner. Thank You to the N.J. Veterans Service Council. Thank You to American Legion, Camden County Sr. Vice Commander Mildred DiFante. Thank You Burlington County Times for an excellent editorial on Agent Orange. Thank You Margaret Finch for all the research work at the Rutgers Library. And to so many other people who support the work of this Commission. �COMMISSION EXPANDED TO NINE MEMBERS Legislation introduced by then Assemblyman Richard Van Wagner ; and Senator Daniel Dalton called for expanding the New Jersey Agent Orange Commission from seven members to nine members. The legislation received quick action in both the Assembly and Senate and was signed into law by Governor Kean on December 14th. As we go to print with the Update, one of the two additional- appointments have been made and there are indications that the remaining vacancy may; be filled soon. All Members of the Commission are appointed by the Governor and are unsalaried. By law, six of the nine appointments must be Vietnam Veterans. The eight Members are: * * * *-. Allen E. Falk, Esquire James Credle Robert P. Marasco Guy A. Wiener Laura E. Morrow, M.D. Ralph W. Fogleman, DVM Peter Kahn, Ph.D. * Paul Licitra *"- Dr. Michael Gochfeld serves as Special Consultant to the Commission *. Denotes Vietnam Veteran NEW COUNSELING RESOURCE The Veterans Administration has recently awarded two contracts in South Jersey specifically geared at providing community-based re-adjustment counseling for Vietnam Veterans. Vietnam Veterans need not be .service connected to utilize the counseling programs. We: would encourage community mental health providers, legislative offices and the Veterans organizations to "spread the word" concerning the availability of this new service. In Burlington County, the contract provider is Drenk Memorial Guidance Center and in Gamderi and Gloucester Counties, the provider is Family and Psychological Services of Cherry Hill, ; Vietnara_Veterans must make the initial contact with the Philadelphia VA Vet Center. Their phone number is (215) 672-0238. . - , -. • Reunion - Vietnam - Former Members of the 199th Light Infantry Brigade. For information concerning unit reunion, contact: Mr. John C. Donahue = . 11 Ahern Avenue . Windsor Lock, Conn. 06096 � 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. 5819 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>New Jersey Agent Orange Commission Date A point or period of time associated with an event in the lifecycle of the resource 1984-03-01 Title A name given to the resource Commander's / President's Update on Agent Orange ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/1e2504df09bb653827b09022aba2d434.pdf cbf8b7f905765c4d4cd31327179d91ba PDF Text Text Item D Number °5586 D (j0t Scanned Author Corporate Author Report/Article TltlB Comments from Bart Kull, Special Assistant to the Deputy Undersecretary for Intergovernmental Affairs, HHS, Alternate Chair, Agent Orange Working Group, to National Veterans Affairs and Rehabilitation Conference, American Legion, regarding, Agent Orange Research Overview, dated February 15, 1982, Capital Hilton Hotel, Washington, D.C. Journal/Book Title Year 1982 Month/Day Color Number of Images D 8 Descrlpton Notes Tuesday, March 19, 2002 Page 5586 of 5611 �COMMENTS: BART KULL SPECIAL ASSISTANT TO THE DEPUTY UNDERSECRETARY FOR INTERGOVERNMENTAL AFFAIRS HHS ALTERNATE CHAIR, AGENT ORANGE WORKING GROUP TO: .NATIONAL VETERANS AFFAIRS AND REHABILITATION CONFERENCE AMERICAN LEGION DATE: FEBRUARY 15, 1982 PLACE: CAPITAL HILTON HOTEL WASHINGTON, D.C. SUBJECT: AGENT ORANGE RESEARCH OVERVIEW �THERE ARE A LOT OF FALSE ASSUMPTIONS MAKING THE ROUNDS ABOUT WHAT THE FEDERAL GOVERNMENT IS/ OR IS NOT, DOING IN EFFORTS TO GET TO THE TRUTH OF THE ISSUE OF AGENT ORANGE AND ITS IMPACT ON THE HEALTH OF VIETNAM VETERANS. IN VARIOUS STATES/ LEGISLATION IS BEING INTRODUCED AND PASSED BECAUSE/ I THINK/ OF A PERCEPTION THAT THE FED IS NOT DOING ANYTHING, THAT'S NOT REALLY THE FAULT OF THE STATES SO MUCH AS IT IS OUR FAULT, TRUTH IS/ NOT A VERY GOOD JOB HAS BEEN DONE TO GET INFORMATION OUT TO THE PUBLIC, ADDED TO THAT IS THE TENDENCY ON THE PART OF THE NEWS MEDIA TO GO FOR THE SPECTACULAR/ WHICH IS TOO OFTEN THE EXPRESSION OF THE NEGATIVE ASPECTS OF A GIVEN PROBLEM, A PROTEST MARCH ABOUT A PROBLEM GENERALLY GETS HIGHER BILLING THAN A SCIENTIST SEEKING A SOLUTION TO THE PROBLEM IN SOME QUIET LAB, IT'S HARD TO FA'JLT THAT, DAY-TO-DAY NEWS/ AS I BELIEVE WALTER CRONKITE ONCE PUT IT/ is ABOUT THE CATS WHO RAN AWAY LAST NIGHT, THAT'S WHY ARTICLES SUCH AS "AGENT ORANGE/ A SEARCH FOR ANSWERS/" is so IMPORTANT, IT GIVES/ AS COMMENTATOR PAUL HARVEY SAYS/ "THE REST OF THE STORY," �-2WE ARE M A K I N G A CONCERTED EFFORT TO BE A GOOD DEAL M O R E R E S P O N S I V E TO THE NEED FOR PUBLIC I N F O R M A T I O N , JIM TOUCHED ON THE E V I D E N C E OF THAT W H E N HE SPOKE OF SECRETARY SCHWEIKER'S A N N O U N C E M E N T OF THE V E R I F I C A T I O N OF AGENT O R A N G E A E R I A L DUMPS, CHUCK HAGEL/ OVER AT THE VA, is DETERMINED THAT THAT AGENCY BE MORE OPEN AND R E S P O N S I V E TO THIS WHOLE A R E A OF CONCERN. WE A R E I N S I S T I N G THAT S C I E N T I S T S S U B M I T UPDATES O N R E S E A R C H ACTIVITIES WRITTEN IN LAYMAN'S LANGUAGE, RIGHT NOW, THERE ARE 25 SEPARATE/ COMPLEX AND EXPENSIVE RESEARCH \STUDIES UNDERWAY OR COMPLETED IN THE DEPARTMENT OF HEALTH AND HUMAN SERVICES DEALING WITH DIOXINS, THERE ARE OTHER RESEARCH PROJECTS GOING FORWARD IN THE DEPARTMENT OF AGRICULTURE AND THE ENVIRONMENTAL PROTECTION AGENCY, I WOULD LIKE TO BRIEFLY OUTLINE FOR YOU SOME OF THE MAJOR RESEARCH EFFORTS UNDERWAY, THE NATIONAL INSTITUTE OF OCCUPATIONAL SAFETY AND HEALTH is E S T A B L I S H I N G A R E G I S T R Y OF PEOPLE IN THE U N I T E D STATES WHO HAVE W O R K E D ON THE P R O D U C T I O N OF D I O X I N C O N T A M I N A T E D M A T E R I A L S SUCH �-3AS 2-4-5T/ ONE OF THE COMPONENTS OF AGENT O R A N G E , SINCE 1979, THEY'VE BEEN COLLECTING W O R K H I S T O R I E S G O I N G BACK TO THE 1940'S, THE INFORMATION WILL G I V E AN INDICATION OF WHETHER D I O X I N - E X P O S E D W O R K E R S DIE AT A R A T E / OR FROM CAUSES D I F F E R E N T FROM/ THE G E N E R A L POPULATION, IN LATE 1983, P R E L I M I N A R Y RESULTS ARE EXPECTED IT'S CALLED THE "DlOXIN REGISTRY," THAT SAME INSTITUTE is ALSO INVESTIGATING AN ASSOCIATION BETWEEN WORK-PLACE EXPOSURE TO HERBICIDES AND THE DEVELOPMENT OF A MALIGNANT TUMOR KNOWN AS SOFT TISSUE SARCOMA,.,A FORM OF CANCER, IT APPEARS/ FROM STUDIES IN SWEDEN AND IN THIS. COUNTRY/ THAT THERE IS A LINK, THAT HAS TO BE CONFIRMED, THE DIOXIN REGISTRY WILL BE HELPFUL IN ARRIVING AT A DEFINITE CONCLUSION, SINCE 1968/ THE CENTERS FOR DISEASE CONTROL HAS KEPT A REGISTRY OF ALL BABIES BORN WITH BIRTH DEFECTS IN THE METROPOLITAN ATLANTA AREA, BASED ON THE REGISTRY/ THEY HAVE BEGUN A SfUDY DESIGNED TO DETERMINE IF VIETNAM VETERANS ARE AT INCREASED RISK OF HAVING BABIES BORN WITH SERIOUS BIRTH DEFECTS, THEY HAVE IDENTIFIED 7/500 BIRTH-DEFECTED BABIES/ MANY THE CHILDREN OF VIETNAM VETERANS, A CONTROL GROUP OF 3000 BABIES BORN WITHOUT DEFECTS WILL BE USED. �IF THE STUDY DEMONSTRATES THAT V I E T N A M VETERANS HAVE AN I N C R E A S E D R I S K OF F A T H E R I N G A C H I L D W I T H A DEFECT IT MUST THEN BE DETERMINED. IF POSSIBLE/ IF THE I N C R E A S E IS ASSOCIATED W I T H AGENT ORANGE EXPOSURE OR WITH SOME OTHER FACTOR, THE STUDY is SCHEDULED T O - B E COMPLETED BY SEPTEMBER OF NEXT Y E A R , A VERY IMPORTANT RESEARCH EFFORT THAT IS M O V I N G AHEAD R A P I D L Y IS BEST K N O W N AS THE "RANCH H A N D STUDY," IT DEALS W I T H THE PILOTS AND CREWS, K N O W N AS THE R A N C H H A N D E R S / WHO ACTUALLY SPRAYED AGENT ORANGE AND OTHER HERBICIDES FROM FIXED WING AIRCRAFT IN VIETNAM, THEY WERE HEAVILY EXPOSED, THE AIR FORCE HAS CONTRACTED WITH THE Lou HARRIS AGENCY TO CONDUCT A FACE-TO-FACE QUESTIONNAIRE THAT DEALS WITH STATISTICAL DATA/ HEALTH PROBLEMS/ SYMPTOMS AND SO ON/ OF BOTH THE VETERANS AND THEIR FAMILIES. THERE ARE ABOUT 1200 RANCH HAND PERSONNEL INVOLVED/ ALONG WITH 1200 OTHER PEOPLE NOT EXPOSED (FOR CONTROL), ABOUT HALF OF THOSE QUESTIONNAIRES ARE NOW COMPLETED. THAT PHASE ENDING IN APRIL WILL COST ONE MILLION DOLLARS, THE NEXT STEP WILL BRING THESE PEOPLE TO HOUSTON FOR A THREE-DAY/ IN DEPTH/ PHYSICAL EXAMINATION. THAT PHASE HAS ALREADY BEGUN AND WILL BE COMPLETED BY SEPTEMBER, �-5- EVERYTHING WILL THEN BE COMPUTERIZED AND AN ANALYSIS OF THE QUESTIONNAIRES AND THE EXAMS WILL BE MADE, IT IS ANTICIPATED THAT WE WILL HAVE PRELIMINARY RESULTS OF THE ANALYSIS BY THE MIDDLE OF NEXT YEAR, THAT SECOND PHASE WILL COST ABOUT FIVE MILLION DOLLARS. THE VETERANS ADMINISTRATION OFFICE OF ENVIRONMENTAL MEDICINE HAS COMPLETED A FEASIBILITY STUDY TO DETERMINE WHETHER DIOXIN CAN BE MEASURED IN HUMAN FAT TISSUE AND WHETHER ITS PRESENCE COULD BE USED TO DETERMINE EXPOSURE TO AGENT ORANGE, ON THE BASIS OF A SMALL SAMPLING OF EXPOSED AND UNEXPOSED PERSONS/ IT WAS REVEALED THAT EXPOSURE AND HEALTH STATUS DID NOT CORRELATE WITH DETECTED LEVELS OF DIOXIN, HOWEVER/ THE RESULTS INDICATED THAT THE ASSAY METHOD WAS FEASIBLE/ BUT TOO DELICATE AND DIFFICULT TO BE A USEFUL ASSAY METHOD AT THIS TIME, IN M E A S U R I N G D I O X I N IN BODY FAT T I S S U E / YOU ARE L O O K I N G FOR THREE AND FOUR PARTS PER T R I L L I O N , TO DO THIS ARE NOT FULLY DEVELOPED, THE E Q U I P M E N T AND EXPERTISE SCIENTISTS TELL ME THAT ONCE YOU'VE FOUND IT—AT A COST OF TWO THOUSAND DOLLARS PER ASSAY—YOU STILL HAVEN'T GOT A N Y T H I N G BECAUSE IT IS NOT K N O W N IF IT IS THE CAUSE OF ANY D I S E A S E , �JIM SPOKE ABOUT THE PROGRESS OF THE VA EPIDEMIOLOGY STUDY MANDATED BY CONGRESS WHICH IS IN ITS BEGINNING STAGES OF PROTOCOL DEVELOPMENT, AND FINALLY/ A COMPREHENSIVE REVIEW AND ANALYSIS OF THE WORLD-WIDE LITERATURE ON AGENT ORANGE AND OTHER PHENOXY HERBICIDES HAS BEEN COMPLETED, THIS WILL ASSIST RESEARCHERS TO IDENTIFY OPPORTUNITIES TO DEVELOP NEW KNOWLEDGE BASED ON WHAT IS ALREADY KNOWN AND PUBLISHED, COPIES HAVE BEEN DISTRIBUTED TO INVOLVED AGENCIES AND INDIVIDUALS AS WELL AS TO THE GOVERNMENT OF AUSTRALIA, AS YOU CAN SEE/ A GREAT DEAL IS BEING DONE IN TERMS OF RESEARCH, WE WILL HAVE ANSWERS/ AT LEAST THE ANSWERS THAT THE BEST SCIENTIFIC RESEARCH CAN PRODUCE/ TO THE QUESTIONS THAT WEIGH MOST HEAVILY ON THE MINDS OF VIETNAM VETERANS AND THEIR FAMILIES,,,AND ON YOUR MINDS AND OURS, AS JIM HAS SAID/ THE AGENT ORANGE WORKING GROUP WILL NOT CAVE IN TO POLITICAL PRESSURES OR EMOTIONAL HYSTERIA TO PROVIDE QUICK AND EASY ANSWERS,,.THERE JUST AREN'T ANY, NEITHER WILL �—7— WE PERMIT THIS ISSUE TO BE SIDESTEPPED OR UNNECESSARILY DELAYED, THAT WOULD BE A BETRAYAL OF THOSE WHO SERVED THEIR COUNTRY WHEN CALLED UPON TO DO SO. � 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. 198 Folder The folder containing the original item. 5586 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/. Date A point or period of time associated with an event in the lifecycle of the resource 1982 Title A name given to the resource Comments from Bart Kull, Special Assistant to the Deputy Undersecretary for Intergovernmental Affairs, HHS, Alternate Chair, Agent Orange Working Group, to National Veterans Affairs and Rehabilitation Conference, American Legion, regarding, Agent Orange R ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/58d0e199860e4b5437548868f4faaa36.pdf 41fe92fed915151a8e28f8807820cc2a PDF Text Text Item B Number °5597 D not Scanned Author Corporate Author Report/Article Tltlfl Comments from James Stockdale, Deputy Undersecretary for Intergovernmental Affairs, Department of Health and Human Services, Chairman, Agent Orange Working Group, to National Veterans Affairs and Rehabilitation Conference, American Legion, regarding, Agent Orange Update, dated February 15,1982, Capital Hilton Hotel, Washington, D.C. Journal/Book Title Year Month/Day Color Number of Images D 8 Tuesday, March 19, 2002 Page 5587 of 5611 �COMMENTS: JAMES STOCKDALE DEPUTY UNDERSECRETARY FOR INTERGOVERNMENTAL AFFAIRS DEPARTMENT OF HEALTH AND HUMAN SERVICES . CHAIRMAN: AGENT ORANGE WORKING GROUP TO: NATIONAL VETERANS AFFAIRS AND REHABILITATION CONFERENCE AMERICAN LEGION DATE: FEBRUARY 15, 1982 PLACE: CAPITAL HILTON HOTEL WASHINGTON, D.C. SUBJECT: AGENT ORANGE UPDATE �(ACKNOWLEDGE INTRODUCTION AND COMMENT ON CHAIRMAN LENKER.) SINCE I'VE BEEN HERE IN WASHINGTON I'VE HAD THE PLEASURE OF MEETING WITH EXECUTIVE DIRECTOR/ M.YLIO KRAJA; NATIONAL VETERANS AFFAIRS AND REHABILITATION COMMISSION DIRECTOR/ BOB LYNGH; AND JOHN SOMMER/ WHO HAS JUST RECENTLY BEEN PROMOTED TO DEPUTY DIRECTOR TO BOB, I WOULD ALSO LIKE TO RECOGNIZE THE AGGRESSIVE AND THOUGHTFUL SUPPORT THAT THE AMERICAN LEGION HAS GIVEN TO THE VETERANS OF THE VIETNAM WAR IN REGARD TO THE ISSUE OF EXPOSURE TO AGENT ORANGE, I REFER TO THE 1978 RESOLUTION TO SUPPORT STUDIES/ RESEARCH AND ASSISTANCE TO VETERANS EXPOSED; TO THE 1979 RESOLUTION URGING THE V.A, ADMINISTRATOR/ ADVISORY COMMITTEE ON HEALTH/ AND OTHERS TO MOVE WITHOUT DELAY TO DETERMINE THE EFFECTS OF AGENT ORANGE ON EXPOSED VETERANS/ AND THE MANY OTHER INITIATIVES DESIGNED TO BRING THE MESSAGE OF URGENCY TO THE FEDERAL GOVERNMENT IN RESPONSE TO THE DEEP CONCERNS OF VIETNAM VETERANS AND THEIR FAMILIES, ONE OF THE IMPORTANT SERVICES OF THE LEGION IN THIS REGARD IS THE EXCELLENT SERIES "AGENT ORANGE/ IN SEARCH OF ANSWERS" �-2THAT IS C U R R E N T L Y A P P E A R I N G IN ISSUES OF THE A M E R I C A N L E G I O N NATIONAL MAGAZINE, JOHN SOMMER/ J E R R Y ATCHESON AND OTHERS WHO HAVE PRODUCED THE SERIES HAVE DONE AN EXCELLENT JOB, IN ADDITION TO THE OTHER GOOD THINGS ABOUT THE ARTICLES/ THEY SPELLED MY NAME RIGHT AND QUOTED ME CORRECTLY, THE TITLE "AGENT O R A N G E / IN SEARCH OF A N S W E R S / " ACCURATELY REFLECTS WHAT THE AGENT ORANGE W O R K I N G GROUP IS ALL ABOUT/ TOO, WHILE WE DO NOT CONDUCT ANY RESEARCH/ THE WORKING GROUP is CHARGED WITH B E I N G THE O V E R A L L C O O R D I N A T O R / C L E A R I N G - H O U S E AND EVALUATOR OF THE FEDERAL RESEARCH- EFFORT, UNDER THE UMBRELLA OF THE WORKING GROUP/ ALL OF THE FEDERAL AGENCIES INVOLVED IN RESEARCH AND POLICY RELATED TO AGENT ORANGE AND OTHER H E R B I C I D E S USED IN V I E T N A M / ARE D R A W N TOGETHER AND WORK TOGETHER, AS C H A I R M A N / I W I L L INSUT THAT THAT W O R K GO F O R W A R D AS R A P I D L Y AS POSSIBLE; THAT THERE 3E NO H I N T OF P O L I T I C A L GAMEPLAYING; AND THAT CONCLUSIONS REACHED W I L L BE PROVIDED ACCURATELY TO SECRETARY SCHWEIKER'S CABINET COUNCIL ON HUMAN RESOURCES so THAT/ IF NEED BE/ .OUR ADMINISTRATION AND CONGRESS CAN DEVELOP POLICY BASED ON SCIENTIFICALLY SUPPORTABLE FACTS, �-3- THE AMERICAN LEGION/ I'M PROUD TO SAY/ is ONE OF THE RESPONSIBLE VETERANS GROUPS WHICH HAS SUPPORTED LEGITIMATE RESEARCH AND THE NEED TO UNCOVER/ NOT MYTHS/ BUT VALID INFORMATION BORNE OF THAT RESEARCH, THAT NEED TO UNCOVER VALID INFORMATION AS QUICKLY AS POSSIBLE FOR THE BENEFIT OF VIETNAM VETERANS WAS WHAT PROMPTED PRESIDENT REAGAN/ LAST JULY/ TO UPGRADE THE VISIBILITY AND "CLOUT" OF THE AGENT ORANGE WORKING GROUP, HE RAISED THE WORKING GROUP TO CABINET COUNCIL REPORTING STATUS AND EXPANDED ITS MEMBERSHIP AND FUNDING SOURCES, WE NOW H A V E A M E M B E R OF THE W H I T E HOUSE STAFF AS WELL AS A REPRESENTATIVE FROM THE OFFICE OF MANAGEMENT AND BUDGET TAKING PART IN THE MONTHLY MEETINGS OF THE AGENT ORANGE WORKING GROUP/ AS WELL AS ALL FEDERAL AGENCIES INVOLVED IN DIOXIN RESEARCH AND VETERANS AFFAIRS, FURTHER/ BECAUSE OF THE GROWING INTEREST OF THE INTERNATIONAL COMMUNITY IN OUR WORK/ WE ARE GOING TO ADD A REPRESENTATIVE OF THE DEPARTMENT OF STATE TO THE MEMBERSHIP, �HEALTH AND HUMAN SERVICES SECRETARY DICK SCHWEIKER/ WHO is HEAD OF THE CABINET COUNCIL ON HUMAN RESOURCES,,,AND THE MAN TO WHOM THE WORKING GROUP REPORTS,,,HAS EXHIBITED AN INTENSE INTEREST IN THIS MATTER, HE HOLDS THE STRONG BELIEF THAT THE PUBLIC AND VETERANS GROUPS HAVE A RIGHT TO BE QUICKLY ADVISED OF IMPORTANT NEW INFORMATION, YOU MAY RECALL THAT LAST SEPTEMBER 23RD, SECRETARY SCHWEIKER WENT BEFORE THE NEWS MEDIA AND ANNOUNCED THE VERIFICATION OF THE FACT THAT ON A NUMBER OF OCCASIONS/ AGENT ORANGE HAD BEEN DUMPED ON AMERICAN MILITARY INSTALLATIONS IN VIETNAM, THESE DUMPINGS RESULTED FROM THE NEED TO LIGHTEN LOAD BY SPRAY AIRCRAFT WHICH HAD OCCASIONALLY LOST POWER ON TAKE-OFF, THIS NEW I N F O R M A T I O N C O N F I R M E D WHAT HAD B E E N ONLY SPECULATION AND OPENED THE POSSIBILITY OF IDENTIFYING A LARGE/ POTENTIALLY EXPOSED G R O U P OF PEOPLE AS AN AID TO MORE V A L I D RESEARCH, HE R E V E A L E D THIS I N F O R M A T I O N IMMEDIATELY UPON L E A R N I N G OF IT, �-5- SECRETARY SCHWEIKER is CONVINCED THAT THE PUBLIC/ ESPECIALLY V I E T N A M V E T E R A N S / HAS A NEED FOR I N F O R M A T I O N A N D / I N D E E D / HAS EVERY R I G H T TO K N O W , THAT'S THE KIND OF SUPPORT THE WORKING GROUP is GETTING FROM THE SECRETARY AND THE ADMINISTRATION, THERE is A STRONG SENSE OF URGENCY AS WELL AS A RECOGNITION THAT L E G I T I M A T E R E S E A R C H TAKES TIME, I RECOGNIZE ALSO THAT V I E T N A M V E T E R A N S CANNOT BE EXPECTED TO W A I T FOREVER FOR A N S W E R S . SINCE BECOMING CHAIRMAN I HAVE MADE IT VERY CLEAR THAT FOOT-DRAGGING AND BUREAUCRATIC DELAYS WILL NOT BE TOLERATED, IN THIS REGARD I AM PLEASED TO HAVE THE COMPLETE SUPPORT OF THE ADMINISTRATION AND THE FEDERAL SCIENTIFIC COMMUNITY, THE VETERANS ADMINISTRATION HAS COME UNDER HEAVY FIRE FOR WHAT WAS PERCEIVED AS UNRESPONSIVENESS TO THE CONCERNS OF VETERANS RELATING TO AGENT ORANGE, I HAVE REASON TO BELIEVE THAT THAT PERCEPTION IS CHANGING, TO SUPPORT THAT/ CHUCK HAGEL �-6- HAS BEEN RECENTLY NAMED AS DEPUTY ADMINISTRATOR, CHUCK IS A PURPLE HEART VIETNAM COMBAT VETERAN, HE HAS ALREADY EXPANDED THE STAFF AND SPACE RELATED TO THE AGENT ORANGE ISSUE AND HAS SERVED NOTICE THAT THE FULL RESOURCES OF THE V,A, WILL BE DIRECTED. TOWARD PROVIDING VALID ANSWERS BASED ON ACCELERATED RESEARCH/ AND TOWARD DISPELLING THE CHARGE THAT THE V.A. HAS BEEN UNRESPONSIVE TO THE CONCERNS OF VETERANS ABOUT AGENT ORANGE, i MEANWHILE/ THE DEPARTMENT OF DEFENSE ARMY RECORDS SEARCH DIVISION IS CURRENTLY DEVELOPING SOME HIGHLY SIGNIFICANT DATA, THE DETAILS ARE NOT/ AS YET/ COMPLETE, I CAN SAY THAT THE POSSIBILITY EXISTS THAT A LARGE NUMBER OF VIETNAM VETERANS/ EXPOSED AND RELATIVELY UNEXPOSED/ MAY BE IDENTIFIED FOR PURPOSES OF A RELIABLE RESEARCH COHORT, WE ARE VIEWING THAT WITH GUARDED OPTIMISM BECAUSE IT WOULD BE EXTREMELY VALUABLE TO THE CONDUCT OF THE CONGRESSIONALLY-MANDATED VETERANS ADMINISTRATION EPIDEMIOLOGY STUDY, AFTER SOME DELAYS/ THE U.C.L.A. PROTOCOL FOR THAT STUDY HAS BEEN REWORKED/ RESUBMITTED/ AND IS CURRENTLY UNDER REVIEW BY THE AGENT ORANGE WORKING GROUP SCIENCE PANEL AND OTHER AGENCY SCIENTISTS/ AS WELL AS THE CONGRESSIONAL OFFICE OF TECHNOLOGY �-7- ASSESSMENT, IT IS EXPECTED THAT THE REVIEW PROCESS WILL WEED OUT ANY POSSIBILITY OF BIAS OR WEAKNESS IN THE PROTOCOL/ WHICH IS ESSENTIALLY A COOKBOOK RECIPE ON HOW THE ACTUAL STUDY WILL BE CONDUCTED, WE WISH TO MOVE RAPIDLY AND RESPONSIBLY SO THAT THE ACTUAL STUDY AND RESEARCH CAN BEGIN, IN ADDITION/ THERE IS A GREAT DEAL OF RESEARCH UNDERWAY, BART KULL WILL SHORTLY PROVIDE YOU WITH AN UPDATE OF VARIOUS STUDIES, IN CLOSING/ I WOULD RESTATE MY POSITION/ AND THAT OF SECRETARY SCHWEIKER AND THE ADMINISTRATION,,,"THE CONCERNS OF POSSIBLE LONG-TERM ADVERSE HEALTH EFFECTS AS A RESULT OF EXPOSURE TO AGENT ORANGE ARE VERY REAL, THEY DEMAND ANSWERS, THEY DEMAND THE KIND OF DELIBERATE/ OBJECTIVE RESEARCH THAT WILL PROVIDE AS MANY ANSWERS AS SCIENCE CAN GIVE/' WE ARE DEDICATED TO THAT END,..REGARDLESS OF ITS IMPLICATIONS, I WOULD LIKE TO THANK YOU AGAIN FOR THE SUPPORT OF THE AMERICAN LEGION IN OUR EFFORTS, THANK YOU, � 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. 198 Folder The folder containing the original item. 5587 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/. Date A point or period of time associated with an event in the lifecycle of the resource 1982 Title A name given to the resource Comments from James Stockdale, Deputy Undersecretary for Intergovernmental Affairs, Department of Health and Human Services, Chairman, Agent Orange Working Group, to National Veterans Affairs and Rehabilitation Conference, American Legion, regarding, Agen ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/d9deed35bf90fa98d0d3891f4648294b.pdf b964fcc579b6214da039a3c16befe7b9 PDF Text Text item D Number 05530 D Not Scanned Author Corporate Author s ntex u s A y ( •). inc. ROUOrt/ArtlClO TltlB Comments to the EPA Draft Document "Estimating Exposures to 2,3,7,8-TCDD" (June 1987) Journal/Book Title 1987 Month/Day Color n Number of Images ° DOSCPtyton NOtOS Also incluc| ed is a cover letter from Dennis Paustenbach to Alvin L Young. Tuesday, March 19, 2002 Page 5530 of 5611 �SYNTEX (U.S.A.) INC. 3401 HILLVIEW AVENUE, P.O. BOX 10850 PALO ALTO, CALIFORNIA 94303 • (415)855-5050 TELEX 4997273 SYNTEX PLA CORPORATE ENGINEERING DIVISION September 1, 1987 Dr. Alvln Young Executive Office of The President Office of Science & Technology Policy 726 Jackson Place, N.W. NEOB, Room 5026 Washington, D.C. 20506 Dear Al: Enclosed please find Syntex's comments on the EPA draft (June 1, 1987) document entitled "Estimating Exposures to 2,3,7,8-TCDD" by the Exposure Assessment Group. Me hope you will have the opportunity to bring these comments to the attention of appropriate individuals at EPA. The draft, in general, does a credible job of reviewing the literature. However, we take serious issue with some of the exposure scenarios which the EAG constructs to assess human exposure. Using some of their assumptions and exposure scenarios, TCOO in soil would need to be restricted to the 1 ppt level. Equally serious is the EAG's omission of exposure scenarios which reflect the levels of TCOD to which some persons might be exposed; specifically, those having to do with typical residential and occupational settings. We appreciate your providing us with the draft document and with the opportunity to comment on it. It is our hope that the final version will present a more balanced view of human exposure to TCDD contamination. Sincerely yours, K^fk&^sY-u-A-) Dennis Paustenbach, Ph.D. Manager, Environmental and Occupational Toxicology wp/0237e-7 Enclosures �Comments to the EPA Draft Document 'Estimating Exposures to 2,3,7,8-TCDD" (June, 1987) Table of Contents Executive Summary 1 Introduction 7 General Comments 7 Exposure Scenarios 7 Risk Criteria for Small Populations 11 Virtually Safe Dose for TCOD 14 Line-by-Line Comments 21 Fruit and Vegetable Ingestion 84 Incinerator Exposure Parameters 84 Alternate Scenario/Alternate Approach 85 References 88 otc/0237e-36 �Comments to the EPA Draft Document "Estimating Exposures to 2,3,7,8-TCDD" (Draft of June, 1987) Executive Summary The draft document entitled "Estimating Exposure to 2,3,7,8-TCDD" written by EPA's Exposure Assessment Group (EAG) represents a conscientious effort to explore an Important aspect of risk assessment. It appears to be a thoroughly researched document which addresses the question of how to estimate exposure to an environmental contaminant. However, the document contains a number of commissions and omissions which detract from Us capacity to address accurately the problem of environmental contamination by TCDD. These Include: o Uneven organization - The information needed to reconstruct exposure is presented 1n various places in the draft document; better organization would make the document more readable. o Inappropriate exposure scenarios - The proposed exposure scenarios are extreme and do not represent many people who may be exposed to TCDD. o Excessive reliance on mathematical modelling - Mathematical models are only as good as the data Inputted and the available data are often incomplete or unsubstantiated; thus, the final output is suspect. wp/6037r-l �o Inappropriate selection of exposure parameters - Although most relevant data were reviewed, the EAG did not adopt some of the reported values; the EAG did not adequately explain why they were not used nor why the selected values were selected. Of particular concern 1s the use of two Incompatible assumptions: a high level of exposure from the Inhalation of TCDD vapors due to rapid volatilization and a long environmental half-life of TCDD. o Inadequate documentation of the number of people exposed for each proposed scenario - The EAG defined 1n quantitative terms the "reasonable worst case" scenario and should also define the "typical" scenario. In addition, the number of people exposed for each scenario should be presented to justify that these scenarios actually comply with EAG's definitions. o Adoption of linearized, multistage model for deriving the cancer potency value and upper bound incremental risk - The conservatism of this model should be explained if it is used. A major error of commission which needs rectifying involves the Inconsistencies between exposure parameters the authors discuss in the text and those the authors use to estimate human exposure in their sample calculations. For example, scientific papers dealing with environmental half-life were reviewed early in the document, but, in many of the scenarios evaluated, no environmental degradation was assumed to occur. Also, the draft Wp/6037r-2 �document reviewed data estimating dermal contamination by soil, but used an arbitrary value rather than the literature values 1n Its calculations. Such Inconsistencies may arise from multiple authors writing this draft document without the benefit of a final blending process (where the writers reconcile Inconsistencies to devolve a coherent document). Furthermore, perhaps due to multiple authorship, similar Information 1s presented 1n various sections of the draft document. The Information required for estimating exposure 1s found 1n various sections but never 1n one section which makes reconstructing how the EAG developed their exposure values more time-consuming than 1t should be. Most Importantly, the document often addresses settings which are not applicable to those situations which exist, or are likely to exist, and these settings are therefore not of primary concern to risk managers. Many of the exposure scenarios constructed for approximating human exposure to TCOO appear to be extreme situations which probably do not exist or, 1f they might exist, are likely to Involve few people. For example, all of the scenarios assume 1ngest1on of varying quantities of fish, beef and diary products produced on small farms having TCDD contamination. Since the majority of populations potentially affected by TCDD contamination are urban or suburban and do not Ingest TCDD contaminated food, these scenarios would not apply to that majority. It 1s suggested that the document develop scenarios which address urban or suburban dwellers who do not consume food Items produced on contaminated sites. wp/6037r-3 �The authors also need to distinguish explicitly between those scenarios where the TCDD contamination occurred as a one time event and those in which the possibility exists for recurring contamination. For example, situations like Times Beach or Seveso would be one time events, while TCDO emissions from incinerators could well be on-going. Clearly, potential exposures would differ under these two classes of scenarios, with the possibility of recurring contamination likely to pose a higher level of concern. The authors rely heavily on mathematical modelling to derive many exposure parameters. These mathematically-derived exposure parameters are only as reliable, and often much less reliable, as the inputted data. This is because errors within each input value is compounded when several input values are needed to calculate the exposure parameters. Often, a great deal of uncertainty surrounds each inputted value. Thus, it is advisable that all measurable parameters (e.g., TCOO concentration in fish, beef, milk) be substituted for mathematically-derived parameters. The approach presented in the draft document gives too much credibility to these mathematically-derived parameters. Another serious shortcoming of the EAG draft document is that it assumes simultaneously that environmental TCDO volatilizes at a rate sufficient to pose a significant exposure via inhalation, and yet that TCDO does not degrade in many of the scenarios evaluated. These two assumptions are incompatible. If TCDD were as volatile as described, the half-life would be weeks, not years. In all likelihood, the volatile component of TCDD is negligible and not worthy of concern. wp/6037r-4 �The risk criteria under which regulatory agencies take action rest mainly on the size of the exposed population. Agencies with remarkable consistency have evolved the position that for small populations, Individual risks below 10-4 are generally considered de minimus, I.e., one which 1s below a level of concern. The EAG document would benefit from some estimate of the numbers of people to which the various exposure scenarios describe. More Importantly, does EAG know how many people potentially exposed to TCDO contaminated sites who are not described by the proposed exposure scenarios? The EAG document makes a number of assumptions concerning quantitative risk assessment issues which should be acknowledged. The document has adopted the application of the linearized multistage low dose extrapolation model for deriving the cancer potency value and the upper-bound incremental risk. Although due to policy constraints the document has chosen to use this modelling approach, this does not represent the only scientifically valid approach to assessing TCOO's carcinogenic risk at low doses. In fact, in light of TCOO's lack of genotoxicity, 1t represents an untenable scientific position. The EAG document need not make this assumption on TCOO's quantitative risk, since it is a document Intended to estimate exposure and uptake. This policy Issue could be avoided entirely by expressing the exposure estimates in terms of dose rather than in terms of risk, as is done in Table VI-5. wp/6037r-5 �Due to TCOO's lack of genotoxlc activity, the scientific evidence convincingly argues for alternative ways to assess TCOO's activity at low doses. Many non-U.S. regulatory agencies have adopted Virtually Safe Doses (VSDs) which are 600-1500 times higher than the VSD Implied by the EAG draft document. In short, the EAG presents a useful review of the pertinent literature. However, we take exception with the application of some of this Information. We recommend the EAG give serious consideration to the following recommendations and Incorporate them 1n the revised document. wp/6037r-6 �A. Introduction EPA's Exposure Assessment Group (EAG) has circulated a document entitled "Estimating Exposure to 2,3,7,8-TCDD" dated June 1, 1987 1n draft form for review. According to the forward, the purpose of the document is "to provide the most recent exposure and risk estimation methodology for application to 2,3,7,8-TCDD contaminated sites. This methodology will help us set priorities and make decisions required to address this important problem." The following comments pertain primarily to the sections in the EAG document entitled: IV. Lxi^sure; VI. Use of.MethodQ.l.ofliei..to_.Est1mate Exposure to 2.3.7.8-TCDD; and VII. Uncertainty Evaluation. B. General Comments Exposure Scenarlos We assume that the Exposure Assessment Group (EAG) prepared this document, "Estimating Exposure to 2,3,7,8-TCDD," for use by risk managers in making regulatory decisions concerning TCDD contaminated sites. The document categorizes TCDD sites into "contaminated soil scenarios" and "dump/landfill wp/6037r-7 �scenarios." We do not believe this way of categorizing sites optimizes the usefulness of the information to the risk manager or accurately characterizes the nature of current exposure to TCOD. One distinguishing feature among contaminated sites which greatly influences any exposure assessments is whether the contamination represents a one-time event (episodic site) or a recurring event (recurring site). The TCDO can only decrease with time at episodic sites, while at sites next to dumps, landfills or incinerators, the contamination may recur because of the nearby presence of the source. More importantly, for recurring sites, the risk manager needs to make policy decisions regarding the location and operation of future dumps/landfIlls/Incinerators and the potential for increasing numbers of people to be exposed. Unlike the recurring sites, the episodic sites are fewer in number and the potential numbers of people exposed are smaller. Consequently, managing the risks at recurring sites must occupy higher priority than those at episodic sites because of the ongoing nature of TCOD exposure. The Issue of the potential numbers of people affected at each type of site will Influence any risk management decisions. Travis et al_. (1987) conducted a retrospective examination of the level of risk which triggered regulatory action in 132 cases. They considered three variables: (1) Individual risk (an upper-limit estimate of the probability that the most highly exposed individual in a population will develop cancer as a result of a lifetime wp/6037r-8 �exposure), (2) population risk (an upper-limit estimate of the number of additional Incidences of cancer 1n the exposed population), and (3) population size. The findings of Travis et a]_. (1987) can be summarized as follows: 1. Every situation presenting with an Individual lifetime risk above 4 x 10-3 received regulatory action. Those with values below 1 x 10-6 remained unregulated. 2. For small populations, regulatory action never resulted for Individual risks below 1 x 3. For effects resulting from exposures to the entire U.S. population, a risk level below 1 x 10~& never triggered action; a risk level above 3 x 10~4 always did. Consequently, regulatory agencies have taken different action, depending on the magnitude of the risk and the size of the population. Travis et aj.. (1987) summarized their conclusion as follows: "Perhaps the most surprising aspect of our study 1s the consistency found among federal agencies' methods 1n the use of cancer risk estimates for regulatory decisions. With the possible exception of FDA decisions concerning de minimus risks,the history of federal decision making indicates that all agencies are fairly consistent in their Implicit definitions of de manifests and de minimus levels of risk. If the above three guidelines were adopted explicitly, consistency with past decisions would be maintained and the process of regulatory decision making would be simplified considerably." While the exposure scenarios formulated in the EAG draft document may be of theoretical Interest, they appear not likely to be of direct use for risk management in many situations. Further, for the example scenarios to be useful, the EAG should estimate the numbers of people who reside at sites described by the exposure scenarios. For example, the majority of TCOD sites in Missouri, which resulted from the spraying of TCOO-contaminated oil in the wp/6037r-9 �early 1970's, are in urban or suburban areas. Consequently, human exposures in these areas are more likely to resemble those for residential and industrial areas as described by Paustenbach e_t al_. (1986) than those described in this EAG document. The number of people in Missouri who may be exposed under scenario 1-4 (a small farm with a pond where the residents consume fish and cattle raised on the farm for 70 years) or under scenario 5-7 (a small farm with a stream where the residents consume fish and cattle raised on the farm for 40 years) undoubtedly is less than 20, if that many. We know of no regulatory actions which address such a limited population. In contrast, the number of people described by residential and occupational exposure to low levels of TCDD are likely to be in the thousands. The EAG characterization of the above exposure scenarios as "reasonable worst case" (for scenario 1-4) and "typical" (for scenario 5-7) appear to be quite misleading. These scenarios are not applicable to the majority of the potentially exposed U.S. population, and are neither reasonable worst case nor typical. The EAG document (P. VI-4) states: "Describing a "reasonable worst case" involves specifying situations where there is a reasonable probability (e.g., 1% to 10X) of individual events occurring, rather than looking at a situation which would maximize all exposure pathway risks simultaneously. While risks for all scenarios and pathways considered in this chapter are summarized later in a single table [Vl-5], it is very unlikely that people would experience the highest risk for all exposure pathways simultaneously. It would be reasonable to assume than an individual could experience the calculated risk of one to several of the pathways simultaneously." wp/6037r-lO �The label "reasonable worst case" should only be applied to situations that have a reasonable chance of occurring. If a scenario has, for example, 20 events, as 1s the case for a typical scenario described 1n Table VI-4, and each has a 10% probability, then that scenario has a probability of 1 x 10-90 , a very low probability. Although each Individual event has 10X probability, which the EAG characterizes as reasonable, 20 events at 10* individual probability result in an unreasonable scenario. The judgment by the EAG that 1t is highly unlikely that people would experience the highest risk for all exposure pathways simultaneously (p. VI-4) should be highlighted and presented as a caveat to those who use Table VI-5. The temptation 1s too great for the hasty reader to add up the risks across the rows and misapply the information. Risk Criteria.,for jma.ll Populations The EPA has historically regarded one in one million as a de minimus risk, one defined by regulators as not meriting concern. The choice of the de minimus risk needs to be put into perspective. For example, how does this degree of risk compare with the background value for cancer in the U.S., the risk of everyday activities, or with levels which have traditionally triggered action by various U.S. regulatory agencies? wp/6037r-ll �As we discussed earlier, Travis et al. (1987) reviewed past regulatory decisions by the EPA,FDA, and OSHA and noted a remarkable consistency 1n the degree of risk and the population size which trigger regulatory action. In particular, for small populations, risks below 1 x 10-4 never triggered regulatory action. Not only have regulatory agencies taken exception to the unilateral application of one 1n one million risk, but also many common human activities entail risks greatly 1n excess of one 1n one million. Wrenn (1986) has discussed these: "Examination of the risks of common human activities demonstrates ... a lifetime risk of 1 in 100,000 or more is within the realm of, or orders of magnitude below, everyday risks that generally do not cause undue concern. These are risks that people, while they are aware of them and may have some concern of fear over them, do not 1n general alter their behavior to avoid. As Table 1 illustrated, the risks from many activities greatly exceed the level of 1 1n 100,000. In comparison to these background risks of "everyday activities," a lifetime risk of 1 in 100,000 is relatively small. Accordingly, regulatory action will not generally be justifiable unless risks are substantially higher than this 1 in 100,000 "benchmark". wp/6037r-12 �Table 1: Lifetime Risk of Death Per 100,000 Persons from Selected Common Human Activities (Wrenn, 1986) Activity Motor-vehicle accidents Home accidents Fall Drowning Poisoning (accidental) Fires, burns Suffocation Firearms (accidents) Electrocution Air travel (radiation from one transcontinental trip/year) Tornado wp/6037r-13 Lifetime Death Rate per 100,000 1,372 770 343 168 161 140 91 56 37 14 �Finally, the Incidence of cancer for the American population and for people 1n highly Industrialized countries 1s about 1 1n 4. Smoking and lifestyle factors such as diet are believed to account for the bulk of this background rate. If regulatory action were taken to limit further risk to one 1n one million, this would be equivalent to lowering the cancer Incidence 1n a million people from 250,001 to 250,000. Given the above examples, the unqualified use of the one in one million risk criteria 1n managing TCOD risk lacks a strong rationale, and these points should be raised with risk managers who must make such decisions. The inclusion of risks greatly below one in one million 1n Table VI-5 of the EAG's draft document misleads the reader as to the health significance of these risks. The Virtually Safe Dose for TCDD The current U.S. regulatory position on TCDD is articulated in two publications, one by EPA (1985) and the other by the Centers for Disease Control (CDC) (Klmbrough et aJL, 1984). Both agencies treated the TCDD mutagenesis, cardnogenesis, and tumor promotion data similarly 1n their estimates of the potential human cancer risk posed by exposure to TCDD at low doses. Both agencies assume that TCDD 1s a mutagen, that the supposed DNA damage it Inflicts may progress to tumor formation, and that any exposure contributes to a lifetime cancer risk. The tumor promotion data on TCDD are not considered in these risk estimations despite the overwhelming evidence that TCDD has no mutagenic activity (see Shu et aj.., 1987 for a review). Wp/6037r-14 �Upon the assumption that TCOD possesses mutagenlc activity, the EPA has estimated a virtually safe dose (VSD) for TCDD at one In one million risk of approximately 0.64 x 10~14 g/kg/day (EPA, 1985) (= 6.4 fg/kg/day) and the COC of 28 to 1428 x 10~15 g/kg/day (= 28 to 1428 fg/kg/day) (Klmbrough et §_]_., 1984). These estimates are derived from a low-dose linear extrapolation of the tumor data obtained 1n animal tests, the traditional approach used for tumor Initiators. The cancer potency value of 0.156 (ng/kg/day) adopted in the draft document (p. VI-2) Implies that EAG has adopted the EPA approach. In the American Industrial Health Council (AIHC) comments to EPA on risk assessment guidelines (AIHC, 1985), it stated: It is also Important that the assumptions and constraints Included 1n the models be explicitly noted and evaluated. The Proposed Guidelines make the linearized multistage model the model of choice. Or. Roy Albert (then Chairman of the Cancer Assessment Group) described Agency use of that model and the way data are treated in applying the model (Albert 1982): o non-threshold: "if a carcinogenic response occurs at the dose levels used in the study, then responses will also occur at lower doses with incidence determined by the . . . [linearized multistage model]." o "Whenever the multistage model sufficiently well, the data at the model refitted to the rest until an acceptable fit to the does not fit the data the highest dose 1s deleted and of the data. This is continued data is obtained." The mathematics in the model have been disclosed, but the characteristics and assumptions of the model have not been fully explained. AIHC believes that these assumptions and characteristics must be taken Into account so that the values generated by the programs can be fully and fairly evaluated in the multidisciplinary step of risk characterization. wp/6037r-15 �Three characteristics of the computer programs of the multistage model used by the Agency (Global 79 or Global 82) are particularly worth noting: (I) the program has a procedure for calculating a linearized 95% upper confidence limit on added risk, */ but does not apply that procedure to calculate the 95X lower limit on added risk. (II) the model does not calculate confidence limits 1n a statistical fashion. Independent of the linearized constraint. (III) the calculation of the most likely value 1s constrained by rejection of negative parameter values, so that all points on the projected dose response curve are forced to be positive and the response Is forced to Increase with dose despite data to the contrary. Generation of an unconstrained most probable estimate of added risk, as well as unconstrained values for upper and lower bounds, would provide data that assist In judging the biological relevance of the model and the values It generates. This additional Information would assist 1n the exercise of scientific judgment 1n Interpreting the results as part of the risk characterizing process. In contrast to the EPA approach, non-U.S.regulatory agencies have applied safety factors to the results of the 2-year chronic bloassay (Koclba et al_., 1978) of 0.001 yg/kg to derive allowable exposure estimates. These limits are significantly above those of the EPA and the CDC. For a comparison of allowable TCDD levels estimated by various regulatory agencies, see Table 2. */ The linearized multistage model does not Incorporate background tumor rates 1n the calculation. The term "added risk" or "extra risk" represents calculation of the amount of "risk" at particular dose levels over the background rate. Both upper and lower bound limits, therefore, converge on zero. wp/6037r-15a �The Ontario Ministry of the Environment (OME), the State Institute of National Health (SIMM) in The Netherlands, and the Federal Environmental Agency (FEA) of the Federal Republic of Germany have estimated TCDD risk to humans that is significantly lower than EPA. The OME risk assessment uses a no-observable effect level (NOEL) of 0.001 yg/kg/day and a safety factor of 100 to obtain a maximum allowable daily intake of 1 x 10 g/kg/day (= 10 pg/kg/day) for humans (Ontario Ministry of the Environment, 1985). EPA's value of 1 x 10 g/kg/day is approximately 1000 times lower than the OME value. wp/6037r-15b �Table 2 Comparison of Allowable TCOO Intake Calculated by Governmental Agencies Agency EPA1 CDC2 SIMM3 OME4 FEA5 FDA6 2 3 A 6 Risk Analysis Approach Linearized Multistage Linearized Multistage Safety Factor (250) Safety Factor (100) Safety Factor (100-1000) Safety Factor (77) Allowable TCDD Intake (fg/kg/day) 6.4 28-1428 4,000 10,000 1000 - 10,000 13,000 EPA Health Assessment Document for Polychlorlnated D1benzo-P-D1ox1n (1985), Kimbrough et al_. (1984). Vander Heljden et aJL (1982), State Institute of National Health, The Netherlands. Ontario Ministry of the Environment (1985). Federal Environmental Agency, The Federal Republic of Germany (1984). Cordle, F. (1981) (Shu et aj., 1987) wp/6037r-16 �The fundamental difference in the analyses by the EPA, OME, SINH and FEA is how each treats the data on TCOO's likely mechanism of action. Scientists from OME, SINH and FEA regard TCDO as a tumor promoter 1n animals whereas EPA regards TCOO as a tumor Initiator. The following rationale articulated by the OME 1n Us assessment of TCDD risk In cardnogenesls exemplifies the reasoning of these regulatory bodies. In particular, the OME assessment embraces a theoretical threshold, based on TCOO's activity as a promoter 1n animals, and an observable threshold, based on the NOEL Identified 1n chronic animal studies (Ontario Ministry of the Environment, 1985) the OME report noted that: o The NOEL (0.001 yg/kg/day) Identified in rodent carcinogenicity bioassay studies indicates where the threshold level for tumor production by TCDO exists. o While TCDO has been rated as the most potent carcinogen in animals using absolute quantities as a criterion, this must be viewed 1n the context that its carcinogenic properties are expressed at concentrations 2 to 3 orders of magnitude below the 1050 range. o Mutagenicity studies, judged on a battery of short-term tests, Indicate that TCDO is not a mutagen 1n the classical sense. The lack of evidence to suggest that TCDD or its metabolites can directly alter DNA physically or chemically also supports this conclusion. o From the data 1n the above section, it can be concluded that PCDDS and PCDDs and PCOFs, especially TCDD, can produce tumors 1n rodents by an indirect mechanism. A threshold dose exists, as indicated by NOELS from long-term animal studies. The OME risk assessment rejects the quantitative risk analysis approach which uses mathematical models to extrapolate from animal dose-response data to obtain the VSD (Ontario Ministry of the Environment, 1985). In particular, 1t notes the following weaknesses in quantitative low dose extrapolation by mathematical models: wp/6037r-17 �o There are many types of mathematical models and they produce very different risk estimates from the same biological data, o current models assume only direct action by the chemical; current models do not Incorporate Indirect modes of action (e.g. tumor promoters), o current models extrapolate probabilities from measurements made 1n the 10-1 to 10-2 range down to 10-5, iQ-6 or 10-8, I.e., well beyond the realm of biological certainty. The OME rejects the use of the mathematical modeling approach 1n setting standards (Ontario Ministry of the Environment, 1985) 1n the following manner: o Use of these risk-analysis models, 1n this Instance, should therefore be more to indicate the potential range of safe doses rather than to form the basis of a standard. o The non-linear and sex-spec1f1c nature of the rodent bioassay data used and the presence of dose-related primary liver damage at treatment levels causing hepatocellular neoplastlc change (Kociba et al.. 1978, 1979; NTP, 1980) suggest that these risk estimates for cancer incidence may be confounded by direct tissue damage. Lack of knowledge of the mode of action of 2,3,7,8-TCDD also precludes selection of a specific risk-analysis model. The use of the 100-fold safety factor for noncarclnogens by regulatory agencies extends over three decades (Lehman and Fitzhugh, 1954). The OME defended its choice of 100 as the safety factor for TCOO (Ontario Ministry of the Environment, 1985) in the following manner: o This 100-fold safety factor 1s a practical means to handle the uncertainties in extrapolating from animals to humans. It Includes a factor of 10 to extrapolate from animals to humans assuming that animals are less sensitive than humans and another factor of 10 to account for differential sensitivities within the human population. o This factor incorporates a number of considerations to account for uncertainty in extrapolating from animal data to humans, particularly an allowance in case humans are more sensitive than the animal species tested. o Since acute toxidty and long-term animal studies are available, and since the short-term mutagenidty studies and the human epidemiology studies are generally negative, a safety factor of 100 is recommended. wp/6037r-18 �o The NOEL of 0.001 »ig/kg/day for 2,3,7,8-TCDD, determined in the three-generation reproductive study of Murray et al. (1979) and the two-year oncology study of Kociba et al. (1978) (both using rats), 1s recommended as a prudent basis for developing a maximum allowable dally Intake for human PCDD and PCDF Intake. The FDA, like the OME and SINH, has also estimated TCDO a cancer risk to humans which is significantly lower than that estimated by the EPA (see Table 2). The FDA calculated an allowable TCDD dose level of 13,000 fg/kg/day 1n Us fish advisory (Cordle, 1981). This value 1s comparable to the estimate calculated by the OME and 1s approximately 2000-fold higher than EPA's value (Cordle, 1981). The FDA (Cordle, 1981) assigned the following Interpretation to the results of Kociba et al_. (1978): Dose vg/kg/day 0.001 0.01 0.1 Biological Response FDA Interpretation of Data No observable adverse effect Enzyme Induction and liver cell response Increase in liver carcinoma No-observable effect level Lowest effect level Carcinogenic level The FDA took the 0.001 ng/kg/day dose in Kociba et al.. (1978) as a no-observable effect level, applied a safety factor of 77, adjusted for the amount of fish consumed by the 99th percentHe of the U.S. population, and concluded that 25 ppt of TCDD in fish was an acceptable level. Specifically, FDA's reasoning was as follows: If fish containing average TCDD residue levels of 25 ppt (determined by sampling fish) were consumed at the level of wp/6037r-19 �the 99th percentlle (= 36.8 g/day) by the U.S. population, the total human dally Intake of TCDO would be 0.92 ng or 13 pg/kg/day (= 13,000 fg/kg/day) for a 70-kg person (Cordle, 1981). The FDA reasoned that 13 pg/kg/day was less than l/70th of the no-observable effect level, was less than l/700th of the lowest-effect level, and was less than 1/7000th of the carcinogenic level (Cordle, 1981). The FOA further states that for the U.S. population which consumed fish at the 90th percentlle, the safety margin would be even greater than for those who consumed at the 99th percentlle. The FOA has recently reaffirmed 25 ppt TCOO in fish as an acceptable level (Anonymous, 1986). However the FOA has also stated that this level corresponds to a risk of 3 in 1 million, derived by the linear extrapolation approach (Anonymous, 1986). The FDA has offered the following reasoning for Its conclusions. In order for fisheries not to exceed the acceptable level established at 25 ppt, the average TCOD in fish must be below 25 ppt and, in fact, the average is 8 ppt. Further, since fish consumption is not restricted to fresh water fish, and since not all fresh water fish are contaminated or are bottom feeders such as carp or catfish, the percent of contaminated fish consumed is closer to 10% rather than 100%. Also, fish consumption at the 90th percentlle would be used in exposure calculations. If these considerations are taken into account, the daily consumption of TCOO is 13 pg/day (or 0.18 pg/kg/day). This corresponds to a 3 in 1 million risk according to FOA's linear extrapolation approach (Anonymous, 1986). wp/6037r-20 �C. Line-By-Line Comments The following are comments on specific statements contained 1n the document: 1. Page 1-5. This report states "While reasonable worst case scenarios Illustrate that 1n the absence of any controls on disposal of 2,3,7,8-TCDD-contaminated material at the 1 ppb level may result 1n risks 1n the 10-4 to 10-2 range." It 1s difficult to reconstruct what the risks are from exposure to 2,3,7,8-TCDD 1n the various scenarios presented. The equation containing the necessary parameters, the rationale for the parameters, and the results are presented 1n different sections of the document. For example, the parameters for beef 1ngest1on 1s presented on p. VI-22, the rationale for these parameters are found on p. 111-18, IV-30, VI-17, VI-38 and other places 1n the document, and the equation for calculating risk on p. VI-2. The parameters that were used 1n this draft document often are more conservative than a "reasonable worst case", and we have made comments in the appropriate sections. 2. Page 1-5. This report states "Risks calculated for contaminated materials of 1 ppt or below in land-related scenarios were below about 10-6 in all cases regardless of controls, except for the reasonable worst case soil contamination scenarios, where the highest pathway was in the range of 10-5." Kimbrough et al. (1984) estimated that at the 1 ppb "level of concern", average exposure to TCDD is 634 fg/kg/day with a resultant cancer risk of about 10~ . Paustenbach et al. (1986) has commented extensively on the inappropriateness of Kimbrough's assumptions and Kimbrough has admitted her exposure assumptions were overly conservative. The 10-5 risk calculated in this draft document at a wp/6037r-21 �level of soil contamination of 1 ppt 1s due to unreasonable selection of exposure parameters and unreasonable exposure scenarios. We have commented on their 1nappropr1ateness elsewhere. 3. Page 1-5. This report states "Recent literature is divided and seemingly contradictory on the Issue of whether, and how much, 2,3,7,8-TCDD Is taken up Into plants from contaminated soil. The authors of this report conclude that there 1s evidence that 2,3,7,8-TCDD 1s taken up by plants growing 1n contaminated soils, but the amount taken up, or subsequent transport within the plant itself (say, to edible portions) is very uncertain." More studies have been conducted on plant uptake of TCDD than on most of the other parameters discussed 1n this document, and the authors chose to use them in various exposure estimates, e.g., environmental half-life, dermal bioavailability, GI bioava1lab1lity of beef and fish, f1sh-to-sed1ment ratio. Although the data are mildly conflicting, all the data Indicate that plant uptake is low. This makes sense 1n light of TCDD's very low water solubility. As shown at last years International Dioxin meeting 1n Japan, the amounts present are so low that labs are generally unable to accurately conduct the analyses. Some reasonable value could be assumed for certain vegetables if this route of entry needs to be addressed. In all likelihood, TCDD uptake by humans from vegetables 1s low compared with potential uptake through meat and milk. 4. Page 1-6. This report states "For systems where two distinct liquid phases exist (water and a relatively nonpolar organic solvent), much greater mobility of 2,3,7,8-TCDD is thought possible, with associated threat to ground water." There are little field data to verify this statement. It is, of course, true that this may be possible, but the bottom line is that wp/6037r-22 �the oils will migrate and move the TCDO only a short distance vertically, as 1s seen 1n Times Beach. It has been suggested that, In fact, the affinity of TCDD for soil 1s sufficiently great that the presence of organic solvents does not affect Its migration (Yanders, personal communication). 5. Page 1-6. This report states "The weight of evidence Indicates that 2,3,7,8-TCDD is often bioavailable from various materials, although certain materials may bind 2,3,7,8-TCDD very tightly, decreasing the bioavailability by an order of magnitude or more. The data base upon which this conclusion is drawn 1s very slim.11 The present data base clearly indicates that TCDD bioavailability Is media-dependent and less bioavailable from aged soil or fly ash (van den Berg e_t §_]_., 1985; Umbreit et aJL, 1986a). The authors made no effort to factor this into their exposure parameters and this should be reconsidered. It seems inappropriate to suggest that not much is known about TCDD bioavallability on soil. In fact, probably more is known about TCDD on these media than about any other chemical. 6. Page 1-6. This report states "Pharmacokinetic considerations, including back-calculating "background" doses in the U.S. population (if any) from body tissue data, would be a very helpful "reality check" for 2,3,7,8-TCDD risk assessments. At present, however, the published data base is small and cannot easily be used to answer the question of whether a "background" level exists in the general population." wp/6037r-23 �There 1s considerable evidence that a "background" level of TCOD of between 5 and 12 ppt in adipose tissue exists 1n the general population (Sielken, 1987, Byard, 1n press). Gehrlng (1984) and Commoner (cited 1n this draft document by the authors) have proposed methods for back-calculating exposure levels from body burdens. The exposure levels needed to produce the background level of TCOO 1n adipose tissue 1s much higher than the exposure levels estimated for most pathways 1n this draft document. This would suggest that either the general population 1s at much greater risks from their exposure to TCDD than the people exposed to TCDD 1n the scenarios proposed 1n this draft document or that the exposure parameters/mathemtatlcal models used 1n this draft document are Inappropriate. A paper by Leung and Paustenbach (submitted), contains a discussion of how TCDD uptake could Influence the eventual body burden. A review paper by Byard (1n press) suggests that adipose tissue concentration less than 1000 ppt probably poses no Incremental risk to humans. 7. Page 1-6. This report calls for "a limited research program addressing the areas where critical Information 1s needed." A critical area of needed research 1s dermal bloavailability of TCOD from different types of soil. There are many shortcomings 1n Polger and Schlatter (1980). In addition, the amount of soil that 1s 1n actual contact with skin and thus available for absorption needs to be addressed. We would refer the authors to the references discussed in Paustenbach (1987). wp/6037r-24 �Another Important area of needed research 1s species differences 1n the pharmacokinetics of TCDD. More research data supporting the development of a physiologically-based pharmacoklnetlc model (PB-PK) for TCDD would be extremely helpful. By extrapolating the results of this type of model from experimental animals to man, one will be able to better estimate human risk. 8. Page II-l. The report states "Possible exceptions are the new Information on the volatilization potential of 2,3,7,8-TCDD, as predicted by revised Information on Henry's Constant and recent work on increased solubility of 2,3,7,8-TCDD when other organic materials are present." There 1s no new information on the volatilization potential of TCDD. While the value of Henry's constant may be somewhat higher than thought years ago, owing to lower solubility values, there are no experimental data for the rate of volatilization of TCDD (or TCDD isomers) from either water or soils. The use of Smith's equation by Podoll, Jaber, and Mill is valid only for molecules that partition freely between the liquid and the two-dimensional gas phase. The model is Inappropriate when there 1s interaction of the participating molecule at the liquid interface, and such is Invariably the case for TCDD. wp/6037r-25 �Further, if a mass balance were to be conducted using the high rate of volatilization of TCDD proposed by Freeman and Schroy, 1t would be readily shown that the TCDD at Times Beach and elsewhere would no longer be present. Of course, the rapid loss described in this document Is inconsistent with the estimations of a long environmental half-life of TCDD. Volatility of TCDD may depend heavily on the matrix. I.e., the presence of co-contaminants (Spencer and Farmer, 1980); this seems to have been overlooked by Freeman and Schroy. Analogous to the handling of the plant uptake data, the authors should reserve judgment until the data can be reassessed. Recent work by Dr. Armon Yanders at the University of Missouri has clearly shown that the predictions of Freeman and Schroy are dramatically inconsistent with actual field laboratory studies. Discussions with Freeman and Schroy indicate that they are well aware of the shortcomings of their original model and plan to revise their work soon. In light of the shortcomings of the old Freeman and Schroy model, we would suggest that reference to it be deleted until they can revise the model so as to account for the field experience. wp/6037r-26 �We would suggest that you review Hague's book, Dynamics. Exposure and Hazard ...Assessment gl^Ioxlc^ChernicaJs., pp. 143-161, which we believe would clearly show that the vapor hazard for chemicals like TCDD 1s virtually nonexistent. 9. Page III-2. The report states "Freeman and Schroy (1985b, 1986) and Tung et al_. (1985) simulated the concentration profile of 2,3,7,8-TCDD In soil with Initially uniform contamination. As time progressed, the simulated concentration profile tended to be bell-shaped, with a maximum concentration somewhere in the core of the soil column." The migration of TCOD 1s generally dependent on the mode in which TCOD 1s applied to soil, the presence or absence of co-contaminants, the soil type, and numerous meteorological conditions. Further, field and simulated data do not support the "bell shaped" nature of the distribution of TCDD In soil (Palausky et al_., 1986). 10. Page III-l. The report states: "Except In unusual cases Involving mobile, organic co-contaminates, large-scale leaching of 2,3,7,8-TCDD to groundwater from soil Is thought to be unllkley." (Note, however, that some landfills may have these very conditions.) The calculations shown on page II-6 show that the concentration of a co-contaminant, in which TCDD is very soluble, would have to be in the 10X range in order to significantly increase the TCDD solubility. It is misleading for the draft report to refer to 10X solvent loading as having any usefulness in estimating the effect of solvents which might be present in landfills at the ppb or ppm level; fully 3-9 orders lower than the conditions of the test. The statement that landfills may have these very conditions seems highly unlikely. wp/6037r-27 �11. Page III-3. The report states "The authors noted that 'the floods at Times Beach, Missouri, have not redistributed the TCOD over a large area1 and concluded that based on a simulation of the measured concentration profile at some time periods, the volatilization process 1s a major mechanism by which 2,3,7,8-TCDD 1s depleted from the soil." The authors also estimated an environmental half-life of TCDD 1n soil to be much shorter than that estimated by other researchers, and than the environmental half-life used in this draft document. If TCDD is actually depleted by volatilization at the rate estimated by Freeman and Schroy, the sites contaminated at 1 ppb, 1 ppt, and 1 ppq which are assumed in the scenarios used in this draft would be depleted of TCDD very quickly. In Spencer and Farmer (1980), the vaporization rate (flux) of DDT from inert surfaces (soil) was reported as p 0.004 »ig/cm /hr. Since the vapor pressure of TCDD 1s similar to that of DDT, the flux of TCDD from soil can be assumed to be the same as that of DDT. If the concentration of TCDD in soil is 1 ppb, and the depth of contamination is 10 cm, then the TCDD is spread over a 50 cm2 surface [1 ppb = 1 vg TCDD/kg soil = 1 vg TCDD/(50 cm2 3 surface x 10 cm depth), assuming a soil density of 2 g/cm ]. If all of the TCDD is available for vaporization, then all of it would be vaporized within 5 hours, based on the vaporization rate of DDT. It follows then that individuals would not be exposed over their entire life spans. We believe that 1f EPA conducts a mass balance of the TCDD in the soil versus that predicted to be lost per unit time, it will be clear that inhalation of vapor at six feet above the ground does not pose a hazard. wp/6037r-28 �12. Page III-4. The report states "Although the surface concentration may theoretically appear to be relevant 1n some cases, the soil surface 1s not always quiescent, and could be subject to disturbances due to construction activities, erosion, or digging. These activities will expose the subsurface soil and make these soils available for human exposure." The use of a 10 cm depth of soil uniformly contaminated with TCDO 1n some scenarios or a 1 cm depth of soil uniformly contaminated in other scenarios does not factor into account the above statement. Soil turnover will accelerate environmental degradation rates (volatilization, photodegradatlon, etc.), and while this may Increase short-term exposure (if possible), it should also decrease the long-term exposure potential. 13. Page III-6. The report states "Czuczwa and Hites (1986) studied lake sediments and concluded that little photolysis occurred during the long-range transport of atmospheric 2,3,7,8-TCDD on partlculates. This finding appears to discredit the theory that 2,3,7,8-TCDD rapidly photolyzes on the soil surface under sunlight." This inference is probably not correct. First, the tenacious binding of TCDD to fly ash which has been discussed by van den Berg et al_. (1983, 1985) and Silkworth et al_. (1982) suggest that sunlight probably doesn't penetrate the pores of ash. Secondly, one would need to know the initial concentration of the fly ash to know that there has been no degradation. In our opinion, the data collected by Young et al_. (1983) at Eglln and the Seveso exposure (di Domenico et aj.. 1980c) suggest that degradation at the soil surface almost surely occurs, although it may not be as significant as initially believed. wp/6037r-29 �14. Page III-6. The report states "The concentration of 2,3,7,8-TCDD 1n environmental media may depend on the degradation of related congeners as well as that of 2,3,7,8-TCDD Itself, since more highly chlorinated congeners may degrade to 2,3,7,8-TCDD." There 1s no evidence that more highly chlorinated PCDDs are degraded to the 2,3,7,8-lsomer. In fact, the available data strongly suggest that this 1s not the case. EPA's Health Assessment Document for Polychlorlnated D1benzo-p-D1ox1ns (USEPA, 1985), states, Although the degree of photolysis may be related to the extent of chlorlnatlon, positional 1somer1zat1on also plays a critical and perhaps dominant part 1n the photolysis of higher PCDDs. In higher PCDDs, there appears to be preferential loss of chlorine from the 2, 3, 7 and 8 positions (Nestrick et al., 1980; Buser and Rappe, 1978; Choudhry and Hutzinger, 1984). However, Buser (1979) observed the formation of 2,3,7,8-TCDD 1n trace quantities, and PeCDD form photolysis of 1,2,3,6,7,8-HxCDD and 1,2,3,7,8,9-HxCDD. PCDD compounds with chlorine substitutions in positions 2,3,7 and 8 are likely to photodegrade faster than compounds not having these positional substitutions. According to such a predicted rule, it is not likely that photodegradatlon of OCDD and other higher PCDDs will yield a high quantity of 2,3,7,8-TCDD as the stable end product. 15. Page III-6. The report states "However, very few studies have been done on the biodegradation of 2,3,7,8-TCDD in soil." Numerous Investigators have looked at the microbial degradation of 2,3,7,8-TCDD. Matsumura and Benezet (1973) evaluated 2,3,7,8-TCDD biodegradation by 100 microbial strains and found only five strains showed some ability to degrade the compound. Camoni et aJL (1982) found that the addition of organic compost rich in organic matter and microbial flora had little Influence on 2,3,7,8-TCDD degradation. Kearney et aJL (1972) studied the persistence of 2,3,7,8-TCDD in soil from two Maryland locations and found an environmental half-life of wp/6037r-30 �about one year. The environmental persistence of 2,3,7,8-TCDD 1n the Seveso area was estimated to be greater than ten years (d1 Domenlco et al_. 1980) and at Eglin A1r Force Base 1n Florida 10 to 12 years (Young, 1983). It 1s clear that the type of mlcroblal flora among other factors greatly Influences 2,3,7,8-TCDD blodegradatlon. The rationale for knowing the 2,3,7,8-TCDD blodegradatlon rate 1n order to conduct an exposure assessment 1s not clear. What 1s needed for exposure assessment 1s the overall environmental half-life (the sum of degradation by photolysis, volatilization, migration, mlcroblal degradation, etc.). In this regard, we agree that the half-life of TCDD on soil not exposed to sunlight 1s probably between 10 and 30 years (Young, 1983, d1 Domenlco et al_., 1980c). 16. Page III-7. The report states "Although he [Young] stated that the role of volatilization and mlcrobial degradation 1n removing 2,3,7,8-TCDD from soil 1s not clear, he estimated the half-life as 10 to 12 years, based on observed changes 1n soil concentrations." The environmental persistence of 2,3,7,8-TCDD depends on site-specific conditions, as demonstrated by environmental half-lives ranging from one year to greater than 10 years (Kearney et al_., 1972; di Domenlco et §J[., 1980c). When soil from a Missouri horse arena sprayed with 2,3,7,8-TCDD-containing waste oil was removed and used as fill dirt at the Minker and Stout sites in the early 1970's and wp/6037r-31 �was analyzed for 2,3,7,8-TCDD 1n the early 1980's, it was found that relatively little degradation had occurred. (Final Report of the Missouri D1ox1n Task Force, October, 1983). In contrast, d1 Domenlco et a]_. (1980c) found Uttle TCOD on the soil after only 18 months post-release. 17. Page 111-10. The report states "Although the blodegradatlon rate for 2,3,7,8-TCDD has not been established, 1t appears that Its half-life 1n soil 1s 1n the range of several decades... For a lifetime exposure evaluation, it 1s appropriate to take Into account the gradually decreasing 2,3,7,8-TCDD concentration 1n soil from which the contaminant 1s released for human exposure. For a 70-year exposure period, Equation III-3 Indicates that a 30-year half-life causes a 50% reduction in exposure relative to an Infinite half-life (I.e., no degradation). As stated previously, for exposure assessment purposes, only the overall degradation of 2,3,7,8-TCDD 1n soil 1s Important, not blodegradatlon. Because the environmental half-life of 2,3,7,8-TCDD has not been established, for illustrative purposes, inclusion of Figure 2 in the exposure assessment of Schaum (1984) in this document would be especially helpful. In addition, a graph of exposure (ng/kg-day) vs. half-life would also be very helpful. A table developed by Paustenbach (1987) also illustrates that the environmental half-life of TCDD and the actual years of exposure to TCDD impact estimated lifetime dose. 18. Page 111-15. The report states "Many aquatic organisms, Including fish, selectively accumulate polychlorinated dlbenzodioxlns (PCDDs) and polychlorlnated dibenzofurans (PCDFs), which are substituted at the 2, 3, 7, and 8 positions (Rappe et al., 1981; Kuehl et al., 1985, 1986a,b)." wp/6037r-32 �The document goes on to state that this "selective accumulation" may be due to more rapid elimination of other Isomers. Kuehl et aJL (1986) found that the rate of depuration of PCOD/PCOFs decreased with increasing degree of chlorination. Thus, the draft document should more clearly point out that there is no evidence that aquatic organisms preferentially take up PCODs substituted at the 2, 3, 7, and 8 positions. Because bioconcentratlon of 2,3,7,8-TCDD in fish 1s difficult to model, an exposure assessment should be based upon the actual measurement of 2,3,7,8-TCDD in fish in a site-specific manner. Only those parameters that cannot be readily measured should be modelled. Measuring TCDD in fish directly 1s much more reliable than trying to estimate a value for the distribution factor, which Involves too many assumptions. The recent papers by Branson et aj. (1985) and Niimi and Oliver (1986) indicate that the BCF in trout is about 10,000 rather than the range of 2,000 to 238,000 suggested by the water solubility equations. In part, the problems with simple approaches to estimating TCDD's BCF is the enormous water solubility data and the inability of the simple formulas to describe behavior at the extremes of I1p1d and water solubility. wp/6037r-33 �Lastly, the use of an on-s1te and off-site dilution factor infers that the system is at steady state. If contamination of a site was a one-time or episodic occurrence, then these dilution factors would not be applicable. 19. Page II1-18. The report states "The potential for human exposure through consumption of beef and dairy products 1s greatest where the cattle have contact with the soil; soil ingestion by cattle is the major pathway for the transmission of 2,3,7,8-TCOO residue from soil to these animals. The amount of soil ingested by grazing cattle can vary between 2% and 15% of dry matter intake, depending on whether vegetation is lush or sparse (Healy, 1968)." Healy's figure represents an extreme which simply is not applicable for the bulk of U.S. cattle. Due to more sophisticated animal management systems in the U.S., the amount of soil ingested by cattle rarely exceeds 2% of dry matter intake (Fries, in press). According to Fries (in press): This assessment Indicates that there is a high potential for transfer of TCOO from soil to humans through foods of animal origin under some animal management systems. The systems with the most serious potential rarely occur in the U.S. Lactating dairy cows are rarely pastured and some form of supplemental feeding is always employed. Thus, it is unlikely that oil Ingestion would ever exceed 1 or 2% of dry matter intake in practical situations. Cattle raised for beef might often be on pastures with no other feed, but it is the general practice to fatten these animals in feed lots before slaughter. This period of time may be as long as ISO days and animals can gain as much as 60 to 70% in body weight. In addition to metabolism, TCDO concentrations would also be reduced by dilution in the expanding body fat pool. Most hogs destined for slaughter are confined and would never be exposed to contaminated soil. Thus, only cull breeding cattle and pigs might be expected to go directly from soil to slaughter. wp/6037r-34 �The situation may be different 1n other countries and this evaluation must be adapted to local conditions. Particular care should be exercised in evaluating such factors as the extent pasture 1s used in the management system and whether animals are fattened on pasture or have a fattening period in feed lots before slaughter. Land unsuitable for livestock production often will not pose a great risk when used for other purposes. Thus, restrictions on animal access to TCDD-contaminated soil may be more practical than rigorous cleanups. If cattle are placed in feed lots for as long as 150 days before slaughter, much of the Ingested 2,3,7,8-TCDD on contaminated soil may have been eliminated depending on the whole body elimination half-life in cattle. Jones and coworkers found that Holsteln dairy cattle given 0.05 or 75 ug of TCDD per kg body weight excreted over 50% of the administered dose 1n the feces, the majority of this being excreted in the first several days post-treatment (presented at the 6th International Symposium on Chlorinated Dioxins and Related Compounds, Fukuoka, Japan, September 16-19, 1986). In short, the approach and assumptions suggested in the document need to be revised. 20. Page 111-19. The reports states "Assuming, again, that 2,3,7,8-TCDD behaves in a manner similar to PBB, and that the conditions on the Michigan farms represent the typical situation on U.S. farms, a beef fat/soil bioconcentratlon ratio of 0.3 to 0.4 and a milk fat/soil bioconcentratlon ratio of 0.04 are suggested for use 1n the procedures described for exposure assessment in this document and in Schaum (1984)." Unless the composition of fat 1n beef and in milk is substantially different, or the distribution of ingested 2,3,7,8-TCDD is substantially different, on a mass basis, the amount of 2,3,7,8-TCDD wp/6037r-35 �in beef fat and In milk fat should be very similar. Fries (1n press) suggested that the ratio of body fat-to-dlet and milk fat-to-dlet 1s about 3.5 for 2,3,7,8-TCDD. In Part Two of the draft exposure assessment, 1t was assumed for the reasonable worst-case scenarios that Individuals 1n rural farm households consume home-grown beef 44X of the time during their 70 year lifetime. The calculated risks are shown 1n Table VI-5. One of the considerations 1n determining what 1s an acceptable risk 1s to determine the number of people exposed to a particular scenario. It would be useful for this scenario, and for all the other scenarios, to estimate the number of people who may be exposed in such a fashion. We believe that it is critical for risk managers to know what percentage of the nation is likely to be impacted. 21. Page 111-19. The report states "It should be recognized that the significance of soil ingestion as a pathway for animal exposure, and ultimately for human exposure, is greatly reduced under U.S. agricultural conditions (Fries, 1986). Lactating dairy cows are rarely pastured. Beef cattle that may have been on pasture are often fattened for as long as 150 days in feed lots before slaughter, thus giving considerable opportunity for elimination and dilution of tissue residues." Since the USEPA is presumably interested in estimating 2,3,7,8-TCDD exposures of individuals in the U.S., there 1s no need to cite the 2 to 15% range of dry matter intake by New Zealand cattle (Healy, 1968). wp/6037r-36 �22. Page IV-1. The report states "A recent evaluation of the significance of Inhaling volatilized 2,3,7,8-TCDD 1n the vicinity of a contaminated site Indicates that this pathway cannot always be treated as negligible." Although no reference 1s given for this claim, all the available data Indicate that exposure to 2,3,7,8-TCOO by the inhalation route either from particulates or vapor is "negligible" compared to exposure from dermal contact or oral Ingestion. A serious problem with the existing air sampling data for TCOO is that when contaminated particles are captured on a filter, the TCOO can be stripped-off due to the superficial face velocity on the filter, and this TCOD is then captured on the back charcoal filter. Its presence on the charcoal, therefore, is not a reflection of TCDO presence in air as a gas. 23. Page IV-3. The report states "Based on the vapor pressure consideration, Paustenbach et al. (1986) discounted the importance of 2,3,7,8-TCDD uptake via vapor inhalation 1n risk assessment evaluation, and assumed that the human intake via Inhalation is related to the intake of airborne, respirable particulates only. On the other hand, Freeman and Schroy (1985a, b, c) considered the vaporization process to be the most Important transport process for CDDs present 1n soils, and compared the results of their modeling with the concentration data obtained at different depths of the soil column and at different times." If Freeman and Schroy's data are accurate, then hazardous waste sites contaminated to a level of 1 ppb, 1 ppt, 1 ppq would present a very low risk very quickly due to vaporization of TCOO from soil. Also, Freeman and Schroy ignored the fact that the TCOO was 1n waste oil, which considerably impedes TCDO volatilization. wp/6037r-37 �The phenomenon described by Freeman and Schroy 1s not Inconsistent with Paustenbach et aJL 's claim that the vapor hazard 1s not significant. If only a few nanograms of TCDO are lost per day per cubic foot of soil, this presents considerable loss due to volatility. However, the loss of a few yg over 24 hours, when diluted by the ambient air, represents an insignificant risk to humans via Inhalation. Numerous EPA computer models are available which would demonstrate that this is the case. Consequently, Freemen and Schroy's model is in no way inconsistent with the claims by Paustenbach and co-workers. 24. Page IV-3. The report states "Eltzer and Hites (1986), based on a limited experimental study, found that COD in the ambient air was present primarily in the vapor phase (this study is discussed in more detail below)." As mentioned previously, most persons believe that the reason why TCDO is not found exclusively in the particles captured 1n the first half of collection devices 1s because the TCDD volatilizes off the particles. Consequently, the TCDO found in the foam in Eltzer and Hites (1986) is because of revolatilization, not because TCDD is present 1n the ambient air. Such phenomenon has been widely recognized for over 10 years in the field of agricultural hygiene. First principles clearly demonstrate that this must be the case. Almost certainly, these issues plus the break-through phenomenon discussed previously would account for the results. wp/6037r-38 �25. Page IV-3. The report states "For example, Nash and Beall (1980) found ambient air concentrations of 2,3,7,8-TCDD when sllvex spiked with 2,3,7,8-TCDD was applied to turf and field sites." It is unlikely that the authors could have prevented microdroplets or aerosols of sllvex (containing 2,3,7,8-TCDD) from entering the air sampling equipment. This could then result 1n the levels of TCDD detected. In addition, the sampling devices were placed less than two feet above the ground. For a typical 70 kg man who inhales TCDD vapors from a contaminated site, his exposure to the vapors would occur about six feet above the ground. The excess dilution that occurs from two feet above the ground to five feet above the ground certainly reduces exposure considerably. Finally, it Is known that the vapor pressure of TCDD is very low. It is probably much lower after 1t has been in contact with soil for some time (aged). TCDD on aged soil is more difficult to extract off the soil and has been shown to be less toxic than non-aged soil samples containing TCDD. As mentioned, if TCDD volatilization is significant, this would argue for a much shorter half-life than what has been determined by other investigators and what is being used in this draft document. If TCDD volatilization is significant, there should be very little TCDD remaining at the environmental contamination episodes which have occurred (e.g., Seveso, Missouri, Vietnam). wp/6037r-39 �26. Page IV-9. The report states "In reality, the 2,3,7,8-TCOD concentration at the son surface will rapidly approach zero, although the 2,3,7,8-TCDD 1n the bulk soil may have volatilized very little." As discussed by Paustenbach et al_. (1986), this 1s likely to be the case. Importantly, dermal and Inhalation exposure to TCOO for the most part 1s due to soil at the surface. The concentration of TCDD 1n upturned soil due to digging, farming, vehicular activity, etc. will also rapidly approach zero. Regrettably, this critical observation was not taken Into account in any exposure scenarios modelled 1n this draft document. In fact, the EAG state several times 1n the draft document that degradation at the surface is likely to be nonexistent. 27. Page IV-15. The report states "The conditions for photolysis are exposure to sunlight and availability of a hydrogen donor (Crosby and Wong, 1977). Also the presence of a solvent on soil appears to make absorbed compounds more available for photolysis." It is of Interest that under similar experimental conditions, but in the absence of UV radiation, little degradation or loss has been observed. If vaporization were the major process by which TCOD is lost, then the presence or absence of UV radiation would not influence the rate of loss of TCDD from soil. 28. Page IV-15. The report states "They determined the half-lives on leaves as about 1 to 2 hours, and those on soil as longer than 7 hours. All experiments were conducted under natural sunlight without using organic solvents. Accounting for daily and annual fractions of sunlight, Thibodeaux and Lipsky (1985) adjusted the 6-hour half-life derived by Crosby and Wong to obtain an effective photodegradatlon half-life of 7.2 days." wp/6037r-40 �Virtually all the published data support rapid degradation or loss of TCDD on surfaces. It would be appropriate to try to estimate exposure to TCOO taking this observation into account. 29. Page IV-16. The report states "A preliminary photolysis experiment using 2,3,7,8-TCDD absorbed on fly-ash particulates suspended in recirculating air indicated that the photolysis of 2,3,7,8-TCOD in particulate form underwent virtually no photolytic reactions after 30 hours of illumination (Mill, 1986)." The environmental fate and bioavailability of TCOO adsorbed on fly ash are poorly understood. To assume that TCDO on fly ash behaves similarly to TCDD on soil is likely to overestimate markedly exposure to TCDD. 30. Page IV-16. The report states "Eitzer and Hites (1986) reported that 2,3,7,8-TCDD in the atmosphere is all in vapor form. The vapor was captured by adsorption on polyurethane foam. They collected ambient air particulates using a high-volume sampler and 0.1-um pore size filters, and could not detect 2,3,7,8-TCDD in the particulates.• If this statement were true, then there really is no point modelling an individual's exposure to TCDD adsorbed onto particulates. If fly ash were present, the TCDD on the fly ash would have all vaporized since, according to Hill (1986), no photolysis occurs. The most likely explanation is that cited previously. TCDD on particulates is almost certainly revolatilized and subsequently captured on the foam. This is the only reasonable explanation for most of these data. wp/6037r-41 �31. Page IV-17. The report states "In the absence of further experimental data under sunlight conditions, 1t appears that a reasonable value for 2,3,7,8-TCDD vapor-phase half-life at present 1s 1n the range of 2 to 6 hours." A short half-life supports the observation that concentrations of TCOO at the soil surface rapidly approach zero. 32. Page IV-19. The report states "Hawley (1985) used the results of Lepow et al. (1975) and Roels et al. (1980) 1n his assessment of risk from exposure to contaminated soil, and used a value of 0.51 mg/cm2. This value was taken as the soil covering for estimating exposure to children playing outdoors. For adults, Hawley (1985) assumed a value of 3.5 mg/cm2 from doing yard work. Schaum (1984), after considering Snyder (1975), Lepow et al. (1975) and Roels et al. (1980), assumed a contact range of 0.5 to 1.5 mg/cm2 and that this range also represents an average for the entire exposed area of the human body for both adults and children." In Part Two of this draft document, dermal exposure for all scenarios 1s assumed to be to 1 mg dust/cm2/day over 1000 cm2 of surface area exposed, or 1 g dust/day. This appears to be a reasonable value for days when contact to soil/dust occurs. The arbitrary assignment of 80% of days exposed for "reasonable worst case" exposure scenarios and 50% for "typical" exposure scenarios seems unjustified. A better approach would be to base the percentage of days exposed on site-specific cllmatologlcal conditions. If outdoor soil 1s covered with snow or 1f the ground 1s frozen for six months out of the year, the reasonable worst case exposure scenario should not be 80% of all calendar days but less than 50% of all calendar days. Likewise, the number of exposure days for typical exposure scenarios would be correspondingly fewer. Another climatological consideration would be wp/6037r-42 �the number of rainy days for a particular site. Dermal exposure to soil would be less likely to take place on rainy days. These site-specific cl1matolog1cal data can be obtained readily from local or state agencies. 33. Page IV-20. The report states "A similar Issue 1s the length of time when the soil 1s 1n contact with the skin surface. This 1s an Important factor, since 1t will help determine the amounts absorbed." In Part Two, an absorption fraction of 0.5% was used based on the data of Polger and Schlatter (1980). There are several shortcomings 1n using Poiger and Schlatter (1980). First, their data was derived from rats. It has been demonstrated that rats tend to overestimate human dermal exposure by several-fold (Wester and Noonan, 1980). Second, the 2,3,7,8-TCOO was patched onto rat skin for 24 hours. Human exposure to 2,3,7,8-TCDD will rarely be for such a long duration and the contaminated soil will never be patched onto the skin. Using an exposure duration of 24 hours does not appear to be a "reasonable" worst case, but rather an "unreasonable" worst case. A reasonable worst case should be about four hours. Third, the data of Polger and Schlatter (1980) showed a dose-dependent Increase 1n absorption with 0.07, 2.4, and 3.1% absorption at doses of 346, 4666, and 17333 ppb. If 2,3,7,8-TCOO contamination 1s at 1 ppb, 1 ppt, or 1 ppq, the data of Polger and Schlatter (1980) would suggest absorption fractions which would be magnitudes lower than the 0.07%. Fourth, for many solid compounds, there 1s generally a lag phase wp/6037r-43 �prior to absorption into the bloodstream. This is intuitively obvious since it takes time for a chemical to be desorbed off the soil and then penetrate through the epidermis. When conducting experimental animal studies measuring absorption after 24 or 48 hours of exposure, this lag phase is not apparent. If typical human exposure is for four hours or less, then, perhaps this amount of time is insufficient for 2,3,7,8-TCDD to have desorbed off the soil particle so that no exposure by the dermal route occurs. Due to the lack of data for the dermal absorption of 2,3,7,8-TCDD, perhaps a more fruitful approach would be estimations based on structure-activity relationships and the comparison of physical-chemical properties (e.g., octanol:water coefficient, lipid solubility). 34. Page IV-20. The report states "For older children, he [Hawley] assumed soil contact over both hands, the forearms, and the legs from the knees down (0.16 m2). For adults, Hawley (1985) assumed contact on both hands and the forearms (0.17 m2), estimating 3.5 mg/cm2 of soil on the skin for adults." 2 The maximum amount of soil per cm available for dermal absorption should not change between children and adults because only the soil directly in contact with the skin is available. For example, if you put ten layers of soil particles onto skin, still only the bottom layer of soil particles will be available for absorption. The p maximum amount of soil per cm available for dermal absorption will change for different soil types, however. These types of experiments can easily be conducted and have been done by Duggan and Williams (1977): wp/6037r-44 �We made an estimate of the amount of dust retained on the pulp of the forefinger and thumb by taking a pinch of dust from a weighted amount, rubbing the finger and thumb together (the surplus falling back Into the weighed amount) and re-weighing the dust. The results of a number of tests with several different people were in the range of 2 to 7 mg of dust retained per finger and thumb with a mean of about 4 mg, I.e., about 2 mg per finger or thumb. If the surface area of the finger or thumb is known, then one can 2 calculate the amount of soil per cm for the "reasonable worst case" scenario. In Part Two, the amount of surface area used in the exposure assessment is 1000 cm2. It seems unlikely that all 1000 cm 2 would be contaminated with the same amount of soil playing children get on their hands. It 1s even less likely that this degree of contamination would occur repeatedly and routinely. Thus, this exposure assessment parameter represents an "unreasonable" worst case. 35. Page IV-23. The report states "Hawley (1985) first considered studies by Bartek et al. (1972) and Feldman and Maibach (1970) on dermal uptake of various compounds 1n humans when applied as pure compounds or 1n acetone for 24 hours. On the basis of these studies, he assumed the percutaneous absorption rate to be 11% in 24 hours for adults." It 1s not mentioned that the references which Hawley (1985) relied upon, Bartek et al. (1972) and Feldman and Maibach (1975), did not evaluate dermal uptake of 2,3,7,8-TCDD. Moreover, except for caffeine (23.3%), absorption in the first 24 hours ranged from 0.4% of the applied dose to 10.8%. On the basis of these studies, Hawley wp/6037r-45 �(1985) assumed the percutaneous absorption rate to be 11% 1n 24 hours for adults. As explained 1n Comment 33, the only data evaluating 2,3,7,8-TCDD dermal b1oava1lab1!1ty 1s from Polger and Schlatter (1980) and limitations of their study should be stated 1f their data 1s to be used. It 1s not clear to us why Hawley's approach (Hawley, 1985) 1s explained here but not used later 1n the exposure assessment section (Part Two). If Hawley's approach is plausible, then 1t should be used; 1f 1t 1s not plausible, then the reasons that 1t 1s not used and the reasons that an alternative approach 1s used should be stated. The approach suggested by Paustenbach et al_. (1986) should also be considered. 36. Page IV-23. The report states "Absorption from soil contact can therefore be estimated as 0.9% for adults and 1.8% for children; or as a range of 0.07% to 3%, as given by Schaum (1984), with no distinction as to age. The duration of contact, both in terms of physical contact and yearly exposure, can be estimated as 12 hours/day for children and 8 hours/day for adults; and this occurs for about 140 days for children and about 45 days for adults." After summarizing the approach of Schaum (1984) for the duration of contact and the number of days exposed by children and adults, the draft exposure assessment 1n Part Two uses a different parameter without adequate justification or even explanation. As stated in Comment 32, a reasonable and more justifiable approach to estimating the number of days exposed per year would be to take into account site-specific climatological data. wp/6037r-46 �37. Page IV-29. The report states "The data from the tracer element studies, Binder et al. (1986) and Clausing et al. (1986), provide support for a preliminary estimate of average soil 1ngest1on by children on the order of 100 to 200 mg/day, consistent with the "low" estimate used by Schaum (1984)." Both the Binder and Clausing studies have been published (Binder et al_., 1986, Clausing et al., 1987). These two studies do not support the use of a soil 1ngest1on rate of 1 g/day as a "reasonable worst case" over a 5 year period between ages 2-6 as used 1n Part Two of the draft document. Further, these studies suggest that a value of 100 mg/day or less for the toddler years 1s appropriate. The studies by Binder and Clausing estimated soil 1ngest1on by toddlers, at ages where soil Ingestlon 1s greatest. Due to a greater awareness of personal hygiene, 1t is reasonable to assume adults Ingest less soil than toddlers. Kercher and Anspaugh (1984) estimated an adult soil Ingestlon rate of 10 mg/day; HAS (1980) and USEPA (1984) estimated a rate of 20 mg/day. USEPA (1984) also considered adult soil Ingestlon to be about one-fifth of the child's rate. Schaum (1984) considered adult soil ingestion to be "negligible." In several risk assessments, the adult rate of soil Ingestion was always lower than the child's rate (Kimbrough et aj.., 1984, Paustenbach et al_., 1986, Eschenroeder et al.., 1986). wp/6037r-47 �Because adult soil 1ngest1on is not zero and arises out of Incidental hand-to-mouth activity, one approach to estimating adult soil ingestlon 1s to base 1t on the extent to which hands are contaminated, the fraction of the hands that get Into an adult's mouth, and the frequency. 38. Page IV-31. The report states "The potential effects of "market dilution" of beef and dairy products on human exposure are discussed briefly 1n Schaum (1984), at more length by Fries (1986), and at much greater length in U.S. EPA (1985b) for the particular case of cattle production 1n Missouri." It is very unlikely that an Individual will Ingest beef contaminated with 2,3,7,8-TCOD for an entire 70 year lifetime. Environmental contamination occurs episodically and is either remediated or the residents are evacuated. Nowadays, very few people reside at the same location for 70 years. The 11,000 and 6,400 days of exposure representing a reasonable worst case and a typical case are overly conservative. The value of 44X for the percentage of home-grown beef consumed by rural farm households was obtained in a survey conducted 21 years ago (USDA, 1966). A survey today would certainly show a smaller percentage. In addition, a survey today to determine the number of people who may be exposed for 70 years or even 40 years would probably result in a very small number. The author's own criterion of "reasonable worst case", which involves a probability of 1 to 10%, would most likely not hold. Wp/6037r-48 �As for the dilution factors used (Table VI-4), 1t seems Inconsistent that the on-s1te dilution factor is 1.0 (no degradation or removal) but the off-site dilution factor 1s greater than zero. Using an on-s1te dilution factor of 1.0 assumes that the mode of contamination is continuous. It would not hold if the mode of contamination was episodic. Using an off-site dilution factor greater than zero Infers that contaminated media leaves the contaminated site (on-s1te). If that 1s the case, then, uncontaminated media off-site will also dilute the contaminated media on-s1te and should be considered. Finally, as mentioned 1n the comments herein, the beef fatrsoil and dairy fatrsoil ratios should be similar. Several investigations have found that 2,3,7,8-TCDD in mother's milk, on a fat basis, 1s similar to the level found in body fat (Rappe et al_., 1984), Under steady state conditions, there Is no reason to believe that the 2,3,7,8-TCDD fat level in one region of the body would be different from another region. 39. Page V-l. The report states "Most contaminated soils tested so far (five) show bioavallability of about 25% to 50% that of 2,3,7,8-TCDD In corn oil given by gavage. Three soil samples spiked with 2,3,7,8-TCDD had b1oava1lab1l1ties in the 40% to 70% range. Based on limited data, 2,3,7,8-TCDD in fly-ash proved roughly 25% as bioavailable as 2,3,7,8-TCDD from solvent extract of the fly-ash." wp/6037r-49 �Several recent studies have addressed the gastrointestinal absorption of TCDO contaminated soil (McConnell et aJL, 1984; Umbrelt et a . , ]. 1985; Paustenbach et aJL, 1986). Paustenbach et aJL (1986) reviewed the relevant animal data pertaining to gastrointestinal absorption of TCDD contaminated soil and discussed some of the factors which may have contributed to the range 1n data reported: Poiger and Schlatter (1980) published the first study on this topic. They dosed rats orally with laboratory prepared TCOD contaminated soil and monitored the % of administered dose in the liver. Their data suggest that as the time of contact between the soil and TCDO (known as aging) Increased, the oral bloavallability decreased. McConnell et al_. (1984) studied Missouri soil contaminated with TCOD. They looked at the liver concentration of TCDD in the guinea pig and rat, and aryl hydrocarbon hydroxylase (AHH) induction in the rat, following soil ingestion. They concluded that TCDO absorption from soil by test animals 1s highly efficient, but that they had difficulty in arriving at an exact percentage for bioavailability. In the CDC assessment, Klmbrough et aj. (1984) used a 30% bioavailabillty value (1984) and cited McConnell et al_. (1984) as the reference. Luder et aj. (1986) republished some of the original data from McConnell et aj_. (1984) and concluded the oral bioavailabllity was 50%. However, the data of Lucier et a_L (1986), suggested the bioavallability was dose dependent - 24% at 1 yg/kg and 50% at 5 yg/kg TCDD. Luder et aj.. (1986) estimated oral bioavailability by comparing the liver TCOD concentration of control rats dosed with TCDD in corn oil with experimental rats dosed with TCDD on Missouri soil. In a recent abstract, Umbrelt et aj.. (1985) reported bioavallabiHty of less than 0.05% for a New Jersey manufacturing site. This work was subsequently published (Umbreit et aJL, 1986) wherein they reported oral bioavailability of 0.5% for soil at a manufacturing site and 21% for a salvage yard in Newark. In this paper, the authors attributed an oral bioavailabllity of 85% to the data presented in the paper by McConnell et aj. (1984). Umbrelt and coworkers did not discuss how they defined or calculated bioavailabllity for their own data or in their interpretation of the data of McConnell et aj. (1984). wp/6037r-50 �Some of the confusion concerning the value for oral bioavailability undoubtedly arises because of the ways investigators have calculated bioavailability. Apparently, some may have used AHH induction as the basis for calculation, while others have used actual liver levels of TCOD. Thus far, none has used a total material balance, including the amount in all tissues and in excreta, as the basis for comparison. Recently, officials of the EPA (Environ. Reporter, 1986) and CDC (Chem. Reg. Reporter, 1986) cited 85% as the bioavailability of dioxin in soil, in spite of the apparent differences between testing methods and methods for defining bioavailability. Bonaccorsi et aj.. (1984) have also published a paper on oral bioavailability in the rabbit. They compared liver levels of dioxin 7 days after an oral dose of Seveso soil or a comparable TCDD dose in alcohol. They reported that absorption of soil-bound TCOD from Seveso was 32% that of TCDD in alcohol. The divergent results on oral bioavailability reported in the literature may occur for several reasons, which will be discussed below. Umbreit and co-workers (1986) and Poiger and Schlatter (1980) have also offered explanations for the discrepancy. The dioxin concentrations in the soil samples for the various laboratories were similar, but other conditions were quite different. For example, the bolus size (the amount of soil administered to the animal) varied markedly among the studies, as did the amount of TCDD taken up in the liver. The data from the three studies suggest that the larger the quantity of soil (i.e., larger dose of dioxin) given to the animal, the larger percentage of uptake by the liver. There are a number of physiological (e.g., residence time and G.I. motility), biochemical (e.g., liver enzyme induction) and physical (e.g., low concentrations bind more tightly to soil, soil type, co-contaminants) reasons why this might be expected. Due to a lack of experimental data, a similar inference cannot be drawn for the rat. The guinea pig data suggest that when the amount of soil ingested is low (on a mg/kg basis) - a condition which more closely resembles that seen in children - the percent GI absorption is lower than the 30% figure used by CDC. The level of organic matter in soil may also be an important variable. The New Jersey soil used by Umbreit et al_. (1986) contained a high organic loading in the form of asphalt-like residues, as well as natural organic content. Interestingly, when this soil was stripped of its organic loading, and the dioxin was reapplied, bioavailability approached 23% (Umbreit et al_., 1986), which supports the hypothesis that increasing amounts of organics in the soil may decrease the bioavailability of TCDD. wp/6037r-51 �In summary, 30% b1oava1labH1ty of TCOO 1n soil 1n the G.I. tract appears to be a more reasonable estimate. Shu et aj. (1987b) studied the GI absorption of TCDD 1n rats fed TCOD contaminated soil. They reported that approximately 43% of the TCDD on Times Beach contaminated soil was absorbed. They also pointed out that the 80% GI absorption value under consideration by EPA (1987) was scientifically groundless: The Implications to the public health of trace amounts of 2,3,7,8-TCDD in the environment are under evaluation by regulatory agencies 1n the U.S. and Western Europe. One major consideration 1n such evaluations 1s the contribution to human exposure via ingestion of TCDD contaminated soil. An 80% figure 1s under consideration by some regulators for estimated human exposure. A contractor for one agency has, in fact, used a value of 100% bioavailability for estimating human bioavallabiHty. Several studies have investigated the oral b1oava1lab1lity of TCDD from contaminated soil in animals. Most have reported estimates of 25-50%, although one has reported <0.5% and 85%, depending on the source of the contaminated soil. This paper reports an oral bioavailability of approximately 43% in the rat dosed with environmentally contaminated soil from Times Beach, Mo. This figure did not change significantly over a 500-fold dose range of 2 to 1450 ng TCOD per kg of body weight for soil contaminated with approximately 2, 30 or 600 ppb of TCDD. This paper also discusses the methodologic shortcomings which underlie the <0.5 and 85% estimate. The relevance of animal oral bioavailability data for the human remains to be evaluated. However, since regulatory agencies use animal data for extrapolating to humans, the 43% figure would be more accurate than the 80% or 100% estimates. Adoption of the 80% estimate would overestimate human exposure from ingestion of TCDD contaminated soil by approximately two-fold. Various estimates of oral bioavailability of Missouri soil have appeared in the scientific literature. Some of these have derived from original studies, while others have derived from reinterpretation of previously published data. Table II summarizes the origins of these published figures, which range from 25 to 85% for Missouri TCDD-contaminated soil and <0.5 to wp/6037r-52 �21% for New Jersey contaminated soil. These estimates are used by scientists (Klmbrough, et §_]_., 1984; Paustenbach, et aj_., 1986; Schaum, 1984) and by regulators (Des Rosier, 1986; Houk, 1986; EPA 1987) to calculate exposures of humans to TCDD, and 1n turn Influence regulatory decisions. Because of the considerable social and economic Impact of these decisions, the reasons for the discrepancies 1n the oral bloavallability data for TCOD merit review. The following discussion examines the assumptions underlying the 25, 50, and 85% estimates for Missouri TCDD-contam1nated soil, as well as the validity of these assumptions. The earliest study was conducted in rats and guinea pigs by McConnell, et §1. (1984) (Table II). This 1s the study which Kimbrough, et a]_. (1984) used to arrive at a figure of 30% for oral b1oava1lab1!1ty of TCDD which they used 1n their evaluation of potential human exposure 1n residential sites. This study by McConnell, et a1_. (1984) also provided the raw data for subsequent relnterpretatlons by Luder, et al_. (1986), who estimated a 25-50% oral b1oava1labH1ty for TCOD 1n rats, and by Umbreit, et al_. (1986a), who estimated a figure of 85% for oral bloavallability of TCDD 1n rats based on the guinea pig data of McConnell, et a1_. (1984) (Table II). McConnell and coworkers (1984) studied the hepatic uptake of TCDD 1n the rat and the guinea pig after administration of oral doses of Missouri soil contaminated 1n-s1tu with TCDO. The study utilized soil from Times Beach, MO and Minker Stout, MO which was contaminated at 770 and 880 ppb, respectively, with TCOD. The hepatic TCOD concentration 1n the rat determined on day 6 following dosing was reported only for the highest dose examined (5 yg/kg). Because this dose 1s significantly lower than the L050 dose estimated in rats (22 and 45 yg/kg in male and female rats, respectively, Schwetz, et aj., 1973), any toxidty in the animals 1s unlikely to influence the calculation of bioavailabllity based on liver TCDD levels in these rats. However, this 1s probably not the case for the guinea pig study, 1n which liver TCDD, determined 30 days following oral dosing or at time of death, was used to estimate oral bioavailabllity (Umbreit, et al_., 1986, and personal communication). At the lowest dose administered to the guinea pigs (1.1 and 1.3 yg TCDD/kg of Minker Stout and Times Beach soil, respectively), no animals died. At the mid dose (3.3 and 3.8 yg TCDD/kg of Minker Stout and Times Beach soil, respectively), 2/6 and 1/5 animals died, respectively. At the high dose (11.0 and 12.8 yg TCOO/kg of Minker Stout and Times Beach soil, respectively), 6/6 and 5/5 animals died. Because the animals at 30 days following dosing were either dead or were moribund, one would not expect the mid- and high dose data to provide reliable values for estimating bioavailabillty. For the mid-dose animals wp/6037r-53 �that survived the 30 days, the excretion of TCOO was very likely affected by the toxicity from TCOO. The data for the low dose were not useful for estimating bioavailability since the amount in the amount in the liver fell below the detection limit of 1 ppb. McConnell, et al_. (1984), in fact, did not estimate bioavailability in the rat or the guinea pig on the basis of these data. McConnell, et al_. (1984) presented additional evidence that the guinea pig data are unreliable for estimating oral bioavailability. For identically dosed animals, the amount of TCOO found in the guinea pig livers was higher in those that died (before 30 days post dosing) than in those that survived (sacrificed at 30 days). Factors that may be responsible for this effect are (McConnell, et aj_., 1984): 1) The wasting syndrome, wherein the TCOO initially in the body may mobilize from fat stores and accumulate 1n the liver. 2) The greater metabolism and excretion of TCOO in the survivors. Consequently, the guinea pig liver levels mainly reflect lexicological aftermaths rather than bioavallabllity processes which precede the development of toxicity. McConnell et al_. concluded: "Although one has difficulty in arriving at an exact percentage for bioavailability, the absorption of TCDD from soil appears to be highly efficient 1n the guinea pig and rat models." (McConnell et al_., 1984). Umbreit, et aJL (1986a) reported that oral bioavailability of TCDD from contaminated soil obtained from a manufacturing site and metal yard in New Jersey had in the guinea pig was <0.5% and 21.3%, respectively. However, these results were obtained from comparison of hepatic levels of TCDD obtained from positive control animals (TCDD placed on decontaminated soil 1 hr before use) 19 days after dosing and from experimental animals (manufacturing site or metal yard soil contaminated sometime before 1970) 60 days after dosing (Table IV, Umbreit, et al_., 1986a; Umbreit, et al_., 1986b and personal communication, 1986). These estimates of oral bioavailabllity are compromised by the fact that hepatic concentrations of TCDO of the positive control and experimental animals were compared at different times. Whether one uses the TCDD half-life in guinea pigs of 30 days (Gasiewicz and Neal, 1979) or 93 days (Olson, 1986), the unexcreted TCDO in the positive control (measured on day 19) would be approximately 3 times higher relative to that 1n the experimental animals (measured on day 60), based solely on pharmacokinetic considerations. Moreover, by day 19, 7 of the 8 positive control animals had died, a sign of severe toxicity in these animals. Consequently, a bioavailability estimate derived from comparisons of the TCDD levels in these guinea pigs reflects, to a large degree, differences in toxicity and pharmacoklnetics rather than bioavailability. wp/6037r-54 �Umbrelt, et aj.. (1986) also recalculated the guinea pig data of McConnell, et al_. (1984) and reported an oral b1oava1lab1Hty of approximately 85% for Missouri soil (Table II). Regulators have subsequently focused on the 85% estimate rather than the 30% figure used by Klmbrough, et al_. (1984) (Oes Rosier, 1986; Houk, 1986; EPA, 1987). For reasons that have already been discussed, the use of the guinea pig data of McConnell, et al_. (1984), 1n which up to 100% of the animals died at the high dose, for calculating oral bioavallability would yield unreliable values. Umbrelt also Indicated that when he recalculated the data more recently, he obtained a range in b1oava1lab1!1ty of approximately 6-60% rather than 85% (Umbrelt, personal communication, 1986). According to his calculations, the calculated b1oava1labH1ty Increased 10 fold as administered dose Increased 3 fold. This observation constitutes further evidence that the use of liver TCDD levels 1n these guinea pigs to estimate bioavallability can create artifacts. On the basis of the estimates obtained from the New Jersey soil studies and their reinterpretation of the guinea pig data of McConnell, et aj.. (1984), Umbreit, et al_. concluded that the oral bioavailability of New Jersey soil is much lower than Missouri soil. For reasons already discussed, estimates of oral bioavallability from the data on the New Jersey soil and from the ^interpretation of the guinea pig data of McConnell, et al_., suffer from serious methodological shortcomings. It should be noted that hepatic levels of TCDD 1n the rat measured in this study are not directly extrapolatable to levels 1n humans. Comparisons of hepatic levels of TCDD among different species have Indicated that 1n rats the liver retains TCDD to a greater extent than livers of monkeys (Piper et al_., 1973; Allen et §1., 1975; Rose et §!_., 1976; Van Miller et al_., 1976). While the liver:fat ratio for TCDD is approximately one or greater than one in the rat, the ratio is substantially less than one 1n the monkey (Neal, et a]_. 1982; Byard, 1987). . . Determinations of TCDD levels in human liver and fat Indicate the liver:fat ratio more closely resembles that of monkey rather than that of rat (Facchetti et a].. 1981; Ryan et a]_. 1985). In conclusion, the oral bioava1labH1ty of TCDD from Missouri soil contaminated with TCDD in the early to mid 1970's has a mean of 43% in rats. This estimate is higher than the 30% figure used by the CDC (Klmbrough, et al_., 1984), but is considerably lower than the 80% and 100% figures which have been suggested by some regulators (Des Rosier, 1985; Houk, 1986; EPA, 1987). Whether the estimated oral bioavailability obtained in rodents is relevant to humans remains to be evaluated. However, if rodent data are used, the 85% estimate was calculated Inaccurately and is based on data which are inappropriate for estimating oral bioavallability. wp/6037r-55 �TABLE I I . LITERATURE VALUES FOR ORAL BIOAVAILABILITY OF IN-SITU TCOD CONTAMINATED SOILS Soil Source Animal TCOO Dose (ng/kfl) % Bloavallable Source of Bioavai labi lity Value Source of Data Mlnker Stout, Missouri Rat 4-,0 0500 Not estimated NA McConnel 1 et al.. 1984 Mlnker Stout and Times Beach, Missouri Guinea PIfl 1,100-12,800 Not estimated NA McConnel 1 et §1. 1984 Mlnker Stout, Missouri Rat 1,000-5,000 50% Lucier et al.. 1986 McConnel 1 et a . 1984 j. and Lucier et a . j. 1986 12,000 <0.5% Umbrelt et at.. 1986 Umbrelt et al. 1986 Manufacturing Site, Guinea New Jersey PIfl Metal Yard, New Jersey Guinea PIfl 320 21.5% Umbrelt et al. 1986 Umbrelt et al. 1986 Mlnker Stout, Missouri Rat 1,000-5,000 25-50% Lucier et a . , 1986 ]. McConnel 1 et al. 1984 Mlnker Stout and Times Beach, Missouri Guinea PIfl 1,100-12,800 85% Umbrelt et al.. 1986 McConnel 1 et al. 1984 (Shu et al.., I987b) wp/6037r-56 �40. Page V-6. The report states "Umbrelt et al. presented liver concentrations of 2,3,7,8-TCDD after death or sacrifice at 60 days following gavage (see Table V-l). Much lower concentrations of 2,3,7,8-TCDD were found in the livers of animals receiving soil from the manufacturing site compared with those receiving the dose in corn oil." The healthfulness of the animals needs to be considered when estimating bioavailability by the presence of TCOO in liver. If the health of the animals is seriously compromised, then the ensuing results become difficult to interpret, if not meaningless. 41. Page V-32. The report states allow for predicting the time burden after exposure ceases. understanding, these analyses physiologic conditions." "Pharmacokinetic analysis may also required for eliminating the body With sufficient data and proper can account for various exposure and Currently, there is considerable effort in trying to estimate "exposure" from measuring an individual's blood or fat levels of 2,3,7,8-TCDD. Biological monitoring can be used to crosscheck an individual's exposure as estimated by the pathway analysis. In order for this to be accomplished effectively, the more data there is of the pharmacokinetics of 2,3,7,8-TCDD in humans, the more reliable it would be to use blood or fat 2,3,7,8-TCDD levels as a surrogate for estimating exposure using the pathway analysis. Using the approach in Gehring (1984), and adjusting it by using what is known about the disposition of 2,3,7,8-TCDD in humans, one can make a reasonable estimate of what the daily exposure was based on the level of 2,3,7,8-TCDD in fat. wp/6037r-57 �The recent paper by Leung and Paustenbach (submitted) describes how this could be accomplished. 42. Page V-33. This report states HlCommoner Approach': Commoner et al. (1985, 1986) discussed ways to calculate the Intake of 2,3,7,8-TCDD per day from human adipose tissue data." Commoner presented his approach of calculating 2,3,7,8-TCDD Intake based on adipose tissue data at two meetings. Thus, his approach has presumably not undergone peer-review. His approach Is not available to the reviewers and thus no comments can be made on Us validity. 43. The factors used In exposure calculations 1n the draft document Is summarized in Table VI-4, p. VI-22. We would like to comment on each factor used. SOIL INGESTIQN (a) Contact rate - For scenarios 1-4, 8-11, and 15, representative of "reasonable worst case" scenarios, the contact rate is 1 g/day. For scenarios 5-7 and 12-14, representative of "typical" scenarios, the contact rate is 0.2 g/day. The values above are presumably based on the studies of Binder et al. (1986) and Clausing et al. (1987). These papers have been published since this document was drafted. Binder and colleagues acknowledged in their abstract that they do not consider these estimates "accurate measures of soil ingestion." Furthermore, the preliminary study by Binder et al. (1986) certainly overestimated soil ingestion rates because it did not include a control group. Clausing et al. (1987) used a control group in their study and concluded that a soil ingestion rate in small children was about 55 mg/day. wp/6037r-58 �While the approach taken by Binder et al_. and Clausing et §_]_. may lead to more "quantitative" estimates of soil ingestlon rates, their preliminary results do not differ from estimates made by numerous other investigators. Duggan and Williams (1977) estimated a soil Ingestlon rate in children of 50 mg/day. The USEPA Air Quality Criteria for Lead (USEPA, 1984) and Day et al. (1975) estimated a rate of 100 mg/day. Hawley (1985) estimated a rate of 165 mg/day for 2.5 year olds and 24 mg/day for 6 year olds after taking into account their lifestyle patterns. Paustenbach (1987) summarized the literature and selected 100 mg/day as appropriate. Based on existing data, we believe a "reasonable worst case" soil ingestlon rate in 2 to 6 year olds should be 165 mg/day and a "typical" soil Ingestlon rate should be 55 mg/day. (b) Absorption fraction - The absorption fraction in all scenarios is 0.3. The available data suggest an oral bioavailabllity of between 0.2 and 0.4. Recently Shu et al. (submitted) reported a value of 0.43 in rats fed TCDD-contaminated soil from Times Beach, Missouri. Thus, a value of 0.3 used in this draft document Is reasonable. It should be noted that TCDD bioavailability may be dependent upon soil characteristics as well as the mode in which TCDD wp/6037r-59 �contaminates the soil, i.e., co-contaminants, and how long the TCOD has been absorbed to soil prior to human ingestion (aging). (Umbreit et al_., 1986a,b). TCDD bioavailability from fly ash may be different from that from soil. (c) Exposure duration - The exposure duration for "reasonable worst case" scenarios is 1500 days and "typical" scenarios is 910 days based on factors of 0.8 and 0.5 reflecting the fraction of time an individual is likely to spend in the exposure area. We believe a better approach of estimating the fraction of time an individual spends in the exposure area is to rely upon site-specific meteorological data. The 0.8 and 0.5 values used in this draft document may be representative of geographic locations where the climatological conditions are temperate year round, e.g., Texas, Arizona. However, for locations where the ground may be snow-covered or frozen six months out of the year or rains every other day, then the above factors are clearly overly conservative. For example, in the St. Louis area, Paustenbach et al_. (1986) determined that about 50X of the days of the year the ground would be frozen or snow-covered, or receive 0.1 inch of precipitation. These weather conditions would most likely prevent soil ingestion. Applying the factors of 0.8 and 0.5 to the remaining 50X of the days of the year would be a more "reasonable" approach. (d) Body weight - The average body weight of children 2 to 6 years of age is 17 kg. wp/6037r-60 �It was determined by 01 em and Lentner (1973) that the average body weight of boys ages 2 to 6 was 17.8 kg. Thus, the value used in this draft document Is reasonable. In terms of using the same body weight for the "reasonable worst case" and "typical" scenarios, for the sake of argument, we wonder why a lesser body weight was not used for the former case. Based on 01em and Lentner (1973), the average body weight In the bottom five percent of boys between ages 2 and 6 Is 13.4 kg. (e) Qn-slte dilution factor - The on-slte dilution factor of 1.0 is used for scenarios 1-7. This is easy to accept since the level of contamination Is specified for these scenarios. What is difficult to accept is the unreasonableness of finding a site that is uniformly contaminated with TCDO. Such an occurrence would probably be limited to Seveso-like situations. The uneven distribution of contamination will result in endless possibilities for exposure scenarios. The decision that soil is contaminated down to a level of 10 cm (p. VI-13), although easy to make for modelling purposes, is difficult to envision in actual field situations. This document should discuss in some detail the ramifications of uneven distribution of contamination and the depth of contamination which would be of concern, or, at the very least, to cite specific references where these concerns have been addressed. (f) Off-site dilution factor - The off-site dilution factor is 0.37 for scenarios 1-4 and 8-11, 0.009 for scenarios 5-7 and 12-14, and 0 for scenarios 15. wp/6037r-61 �The estimation of an off-site dilution factor requires numerous assumptions. These Include estimations for: runoff rates, rates for windblown dust, wind direction frequency, location of the site relative to contaminated site, mixing depth of 10 cm of contaminated soil with off-site uncontamlnated soil, rainfall, eroslvlty Index, erod1b1!1ty factor, etc. It Is difficult to envision that the derived factors can predict, with any reasonable level of confidence, the level of contamination off-site. It would be useful to specify In the draft document the range 1n which the off-site dilution factor could be rather than one particular value. Furthermore, some sort of validation of the above method for any existing site would be very helpful. Finally, it is not apparent whether the on-site level of contamination (e.g., 1 ppb, 1 ppt, 1 ppq) is changing due to either environmental degradation, vaporization or dispersion to surrounding uncontamlnated sites, or dilution of the level of contamination from soil dispersion onto the contaminated site from surrounding, uncontaminated sites. DERMAL EXPOSURE TO SOIL (g) Contact rate - The dermal contact rate is 1 g/day for all scenarios. The studies by Lepow et al. (1975), Roels et al. (1980), and Duggan and Williams (1977) all indicated that the amount of soil wp/6037r-62 �deposited on children's hands 1s approximately 0.5 mg/cm 2. This value should represent a maximum for soil deposition on children as well as on adults. It may be possible to get more 2 dirt per cm than the above value, but It should not result 1n greater absorption since only the soil particles directly In contact with skin are available for absorption. Studies of this type should be very straightforward to conduct, and the EPA should consider doing these studies using different types of soils. The draft document uses a dermal surface area for exposure of 1000 cm2. The 1000 cm2 value may underestimate the surface area of probable exposure. This area corresponds approximately to the surface area of both hands of an adult. On days when exposure occurs, the surface area of soil contact 1s most likely not restricted only to the hands. However, as mentioned elsewhere In our comments, It is unlikely that exposure will take place 24 hours per day. Furthermore, the number of days when soil contact does take place Is likely to be less than 80% of an Individual's lifetime for the "reasonable worst case" and 50% of his lifetime for the "typical case". wp/6037r-63 �(h) Absorpt1on fraction - The dermal absorption fraction is 0.005. This value was derived from the geometric mean of the three data points presented in Poiger and Schlatter (1980). Poiger and Schlatter (1980) is difficult to interpret for the following reasons. One, their study was conducted in rats. It has been shown that rats tend to overestimate human dermal exposure by several-fold (Wester and Noonan, 1980). Two, TCOO was patched onto rat skin for 24 hours. Patching will enhance absorption, and direct contact with TCDD by humans will rarely be as long as 24 hours. Three, their data indicated a dose-dependent increase in absorption, with 0.07, 2.4, and 3.1% absorbed at doses of 346, 4666, and 17333 ppb, respectively. If the TCDD contamination on-site is only 1 ppb, 1 ppt, or 1 ppq, by extrapolation of Poiger and Schlatter1s data, the absorption fraction would be much lower than the lowest value of 0.07X at a dose of 346 ppb. In fact, the absorption fraction would be several magnitudes lower. And if TCDD contamination off-site is a smaller fraction of what it is on-site (e.g., 0.37, 0.009), then the absorption factor would be even lower. Thus, the basis for an absorption factor of 0.005 is quite weak. A better approach may be to try to estimate the absorption factor by using structure-activity relationships (e.g., octanol: water partition coefficients, lipid solubilities, etc.). wp/6037r-64 �Most dermal absorption kinetics indicate a lag phase of absorption. This is intuitively obvious in that the chemical must first desorb off the soil particle before it can be available to penetrate the epidermis. When experiments are conducted 24 hours after dermal application of the test agent, this lag phase will not be apparent. If human exposure to soil is less than four hours, which is more realistic than using 24 hours, then it is quite likely that little or none of the chemical had time to desorb off the soil particle and consequently, little or no absorption would have occurred. (i) Exposure duration - For scenarios 1-4, 8-11, and 15, exposure occurs on 20,000 days. For scenarios 5-7 and 12-14, exposure occurs on 7,300 days. This is based upon 80 and 5OX of total days in a 70 year lifetime, respectively. The comments under soil ingestion also apply here. In short, meteorological data should be used to estimate the exposure fraction. (J) Body weight - The average body weight over a 70-year lifetime is 70 kg for a male. The average body weight of a female over her 70-year lifetime is less than that of a male. For the purposes of this draft document, the 70 kg value is reasonable. (k) On-site dilution factor - The on-site dilution factor for all scenarios is 1.0. Please refer to comments under "Soil Ingestion". wp/6037r-65 �(1) Off-site dilution factor - The off-site dilution factor is 0.37 for scenarios 1-4 and 8-11, 0.009 for scenarios 5-7 and 12-14, and 0 for scenario 15. Please refer to comments under "Soil Ingestion". VAPOR INHALATION (m) Contact rate - The volume of air inhaled per day is 23 m3. This volume is based upon an average adult who spends 22.4 hours/day engaged in light activity, 1.4 hours/day engaged in moderate activity, and 0.2 hours/day engaged in heavy activity (p. VI-28). The volume of air inhaled is associated with the size of an 3 individual (e.g., height, weight). Since the 23 m /day value 1s used to estimate air uptake rate by an average adult, it overestimates the air uptake rate of children. If one value is to be used for an individual over his 70 year life span, a more representative air uptake rate, taking into consideration that the Individual takes 1n less air as a child, should be used. Certainly an individual who was exposed for 40 years should have a different inhalation rate from an individual exposed for 70 years (fraction of time as a child would be different). It is unclear to us why for certain parameters the estimated value for reasonable worst case and typical case is the same. The approach should be consistent in this regard. The values may be subject to discussion once the consistent approach 1s in place. wp/6037r-66 �(n) Absorption fraction - The absorption fraction of vapors 1s 0.75. The authors of this draft document acknowledge that there are no data on the absorption of TCDD vapors by the lungs and that a range between 50 and 100% 1s reasonable (p. IV-14). Presumably, the 75% value selected represents the average of the range Indicated above. Because the vapor concentration of TCDD Is extremely low and TCDD has a high affinity for organics, it 1s likely that the Inhaled TCDD vapors are totally absorbed (or at least Initially adsorbed onto lung tissue and subsequently absorbed). We would suggest the use of an absorption fraction of 100% rather than 75%. (Using a 75% absorption fraction means 25% Is exhaled - that seems very unlikely given the low concentrations of TCDD that we are considering 1n this draft document). (o) Exposure duration - The number of days exposed 1n scenarios 1-4, 8-11, and 15 Is 20,000 days and In scenarios 5-7 and 12-14 1s 7300 days. Unlike exposure duration under "Soil Ingestion" or "Dermal Exposure" which are dependent on meteorological conditions, the exposure duration under "Vapor Inhalation" is dependent on the lifestyle of the individuals living 1n the various scenarios. If the "reasonable worst case" scenario depicts an Individual who spends his entire life in a contaminated area, his exposure duration would be 25550 days (70 x 365). Not only is he there every day of his life, but for 24 hours per day as well as 3 dictated by the contact rate of 23 m /day! Certainly this would not represent a "reasonable" worst case scenario. wp/6037r-67 �The selection of BOX of a 70 year lifetime as the "reasonable worst case" scenario can also be Interpreted that the Individual spends 19.2 hours per day every day of his 70 year lifetime 1n the contaminated area. It would be helpful for the authors to explain the rationale for selecting this BOX as the "reasonable worst case" scenario. Likewise, the basis for the SOX value used to described the "typical" scenario should be defined better. It may be clearer to specify the number of hours per day spent In the contaminated area for the "reasonable worst case" and "typical" case and then to modify the volume of air inhaled for that many hours per day rather than the approach presented. (P) Body weight - The average body weight over a 70-year lifetime is 70 kg for a male. Please refer to comments under "Dermal Exposure". FAT INGESTION (q) Beef Ingestion - The fat ingestion rate from the consumption of beef is 26 g/day in scenarios 1-4, 8-11, and 15 and 14.9 g/day in scenarios 5-7 and 12-14. In Pennington (1983), the amount of beef ingestion was 66, 89, and 61 g/day for males between the ages of 14-16, 25-30, and 60-65, respectively. Based on a percentage of fat in beef of 22-23X, the fat consumption rate would be in the same range as those used in this draft document. Thus, the values of 26 and 14.9 g/day used in this draft document seem reasonable. wp/6037r-68 �(r) Dairy Ingestlon - The fat Ingestlon rate from the consumption of dairy products Is 43 g/day 1n scenarios 1-4, 8-11, and 15 and 18.8 g/day 1n scenarios 5-7 and 12-14. In Pennlngton (1983), the amount of dairy products Ingestlon was 577, 303, and 232 g/day for males between the ages of 14-16, 25-30, and 60-65, respectively. Based on a percentage of fat 1n dairy products of 6-7%, the fat consumption rate would be in the same range as those used in this draft document. Thus, the values of 43 and 18.8 g/day used in this draft document appear reasonable. Due to uncertainties In the consumption estimates of both beef and dairy products, it would be more appropriate to round off the values to two significant places rather than three. (s) Absorption - The absorption fraction of ingested fat in the 61 tract is 0.68. An absorption fraction of 0.68 from the ingestion of beef and dairy products is based on very little information. It is reasonably certain that absorption is media-dependent. There may be data on PBBs that address GI absorption of beef and dairy products in humans that can be applied to TCDD. At this time, 68% seems reasonable. (t) Beef exposure duration - The beef exposure duration is 11,000 days in scenarios 1-4, 8-11, and 15 and 6,400 days in scenarios 5-7 and 12-14. wp/6037r-69 �Trends on the number of rural households consuming home-grown beef would certainly Indicate a marked decline since the USDA-conducted survey of 1966. A graph of percentage home-grown beef consumption versus number of people would Indicate whether the 44% value used in this draft document represents a "reasonable" or "unreasonable" worst case scenario. The EPA's definition of a reasonable worst case scenario is "situations where there is a reasonable probability (e.g., IX to 10%) of individual events occurring." (p. VI-4). The 70-year lifetime exposure used here and elsewhere more closely represents an "absolute" worst case scenario. (u) Dairy exposure duration - The dairy exposure duration is 10,000 days in scenarios 1-4, 8-11, and 15 and 5,800 days in scenarios 5-7 and 12-14. The number or rural households consuming dairy products which have not undergone "market dilution" have certainly declined since the USOA conducted survey of 1966. The unreasonableness of using the 40% value would be borne out if a graph of percentage of home produced dairy products versus number of people is plotted. Given how technology has progressed over the last 70 years, it is unreasonable to assume that for future exposure scenarios the value for home-produced dairy products should be 40%, or that the value for home-grown beef should be 44%. (v) Body weight - The average body weight of a male over a 70-year lifetime is 70 kg. Please refer to comments under "Dermal Exposure". wp/6037r-70 �(w) On-s1te dilution factor - The on-s1te dilution factor Is 1.0 for scenarios 1-7. Please refer to comments under "Soil Ingestion". (x) Off-site dilution factor - The off-site dilution factor is 0.37 for scenarios 8-11, 0.009 for scenarios 12-14, and 0 for scenario 15. Please refer to comments under "Soil Ingestion". (y) Beef fat/soil distribution - The beef fat/soil distribution factor is 0.4 for scenarios 1-4, 8-11, and 15 and 0.3 for scenarios 5-7 and 12-14. The use of a beef fat:soil distribution of 0.3-0.4 appears to be substantiated by available data. (z) Dairy fat/soil distribution - The dairy fat/soil distribution factor is 0.04 for all scenarios. It is unclear to the reviewers whether body fat and milk fat should have different concentrations of TCDD. Preliminary data from Europe has Indicated that to the level of TCDD in human milk fat is similar to that in body fat (Rappe et al... 1984). DUST INHALATION (aa) Respiration rate - The volume of air inhaled per day is 23 nrTThis volume 1s based upon an average adult who spends 22.4 hours/day engaged in light activity, 1.4 hours/day engaged in moderate activity, and 0.2 hours/day engaged in heavy activity (p. VI-28). Please refer to comments under "Vapor Inhalation". In short, the smaller volume of Inhaled air of children was not factored o into the 23 m /day value. (bb) Absorption fraction - The absorption fraction of TCDD on dust particles 1s 0.27. wp/6037r-71 �The draft document cites Schaum (1984) as the basis for deriving an absorption fraction of 0.27 but does not explain Schaum's approach. Schaum (1984) based his approach on data from ICRP (1968). In ICRP (1968), It estimated that for not readily soluble particles (e.g., TCDD absorbed onto particles), 25% would be deposited In the lower lungs, 50% 1n the upper lungs, and 25% exhaled. Of the 25% deposited in the lower lungs, half of that (12.5%) would ultimately be moved up the mucociliary passageway and swallowed. Thus, a total of 62.5% of Inhaled particles would end up in the GI tract. Schaum (1984) assumed a range of GI absorption from 20 to 26%, 100% absorption from the lower lungs, and 0% absorption of exhaled particles to derive a range of pulmonary absorption from 25 to 29%. It is Important to note that the pulmonary absorption fraction 1s dependent on the value for GI absorption fraction. The draft document uses a GI absorption fraction of 30%. Using this value, the pulmonary absorption fraction calculates out to be 31% (0.125 x 1.00 + 0.625 x 0.30 + 0.25 x 0.00). If the GI absorption fraction should change, then the pulmonary absorption fraction must also change. (cc) Exposure duration - The number of days exposed In scenarios 1-4, 8-11, and 15 is 20,000 days and in scenarios 5-7 and 12-14 is 7,300 days. Please refer to comments under "Vapor Inhalation". In short, it is clearer to think in terms of X hours per day as the "reasonable worst case" scenario and Y hours per day as the "typical" scenario and then to adjust daily breathing volumes to wp/6037r-72 �reflect that number of hours rather than to think In terms of X and Y days exposed and the 24 hour breathing volumes. (dd) Body weight - The average body weight over a 70-year lifetime 1s 70 kg for a male. Please refer to comments under "Dermal Exposure". FISH INGESTION (ee) IngestIon - The amount of fish Ingested 1n scenarios 1-4, 8-11, and 15 1s 30 g/day and in scenarios 5-7 and 12-14 1s 6.5 g/day. The Inclusion of a graph of the amount of fish Ingestlon versus number of people would be useful to show that the definition of "reasonable worst case" Is being complied with in the draft document. (ff) Absorption - The absorption fraction is 0.68 for fish by the GI tract. Please refer to comments under "Fat Ingestion". (gg) Exposure duration - The exposure duration in scenarios 1-4, 8-11, and 15 is 2,600 days and in scenarios 5-7 and 12-14 is 1,500 days. The use of the 10% value for the amount of contaminated fish consumed is arbitrary. It is unclear to the reviewer why only the number of years is decreased going from a "reasonable worst case" scenario to a "typical" scenario. Both should be decreased. wp/6037r-73 �(hh) Body weight - The average body weight of a male over his 70-year lifetime Is 70 kg. Please refer to comments under "Dermal Exposure". (11) Qn-site dilution factor - The on-s1te dilution factor 1n scenarios 1-4 Is 1.0 and In scenarios 5-7 Is 0.001. It Is difficult to envision that the pond sediment 1s as polluted as the soil 1n scenarios 1-4. Please refer to comments under "Soil Ingestlon." (jj) Off-site dilution factor - The off-site dilution factor In scenarios 8-11 Is 0.37, 1n scenarios 12-14 Is 0.001, and 1n scenario 15 Is 0.0. Please refer to comments under "Soil Ingestlon". (kk) Distribution factor - The distribution factor 1n fish 1s 5. The fish sediment distribution ratio available In the literature are for specific fish and/or specific organic content 1n sediment. Due to the numerous assumptions that need to be made to come up with a distribution ratio of 5, Its use may grossly overestimate or underestimate actual exposure and should not be recommended. In actual field conditions, one is unlikely to measure sediment TCDD levels to estimate fish levels; instead one is more likely to measure fish levels directly. Modelling parameters should be filled in with actual values if these values are obtainable. wp/6037r-74 �SURFACE WATER INGESTIQN (11) Ingestlon - The average water Ingestion rate is 2 L/day. In Pennington (1983), the amount of water Ingested was reported as 548, 512, and 581 I/day for males between the ages of 14-16, 25-30, and 60-65. These values are 3-4 times lower than that used in this draft document. While 2 I/day could represent a "reasonable worst case", 0.5 I/day probably more represents a "typical" case. When a particular value is based on a 70 kg man the use of this parameter overestimates exposure if exposure occurred only when an individual was a child. Because the intent of this draft exposure assessment is to be able to estimate any individual's exposure, it would be extremely useful if values that change with age can be broken down into several age ranges, e.g., ages 0-1, 1-6, 6-13, and 13-70, rather than one value for all ages. If exposure occurred to an individual between the ages of 0-13, then a more representative value for water ingestion, beef ingestion, dairy products ingestion, fish ingestion, body weight, dermal contact rate, body weight, and respiration rate could be used, rather than the value for a 70 kg adult male. Absorption - The absorption factor of TCDD in water from the GI tract is 0.5. wp/6037r-75 �There are no data on the absorption fraction of TCDD from water ingestion. It Is not readily apparent why the absorption fraction here 1s lower than that used for fish and beef Ingestion. (nn) Exposure duration - The number of days exposed in scenarios 1-4, 8-11, and 15 is 20,000 days and in scenarios 5-7 and 12-14 is 7,300 days. It is probably easier to determine the number of hours per day than the number of days per lifetime which an individual spends at a contaminated site. From the number of hours per day, one then assumes that the daily water Ingestion rate is reduced proportionately. (oo) Body weight - The average body weight of a male over his 70-year lifetime is 70 kg. Please refer to comments under "Dermal Exposure". One parameter that was not listed under "Surface Water Ingestion" is the TCDD concentration in water. The approach used to estimate this value (p. VI-42) requires too many assumptions to make the outcome credible. The authors of this draft document should consider dropping this discussion in light of TCDD's very low water solubility. wp/6037r-76 �44. Page IV-47. The report states: "At the soil organic carbon-water partition coefficient of 486,000 cm/g organic cargon, and organic carbon content (OC) = 0.0002 for groundwater media, the retardation factor becomes Rd = 973. The use of the 486,000 cm/g value for Koc does not seem to have experimental backing. No reference to the literature basis is offered. Aquifers that are relatively free of co-contamination should be more like clean silt-loam soils, for which values of 1 x 10 have been reported (Marple et al_., 1987). Further, it is not clear how the retardation factor was calculated. 45. Page VII-1. The report states "In developing these scenarios, the Exposure Assessment Group tried to construct examples that are relevant to exposure assessment needs faced by the agency. Accordingly, the major focus is on contaminated soil and on landfills containing dioxins and on incinerators emitting dioxins.11 It would be useful if the agency provided information on the number of people that may be exposed under each scenario. 46. Page VII-1. The report states "These physical scenarios are intended to represent either reasonable worst-case situations or situations believed to be more typical, i.e., to more closely resemble occurrences that will be encountered in the field." A definition was given in the draft document of what constitutes a "reasonable worst-case" situation (p. VI-4). A definition should be given of what constitutes a "typical" situation. These can be wp/6037r-77 �supported by indicating the number of people anticipated to be exposed for each situation. 47. Page VII-1. The report states "These scenarios are intended to illustrate a range of circumstances that may be encountered, rather than predict exposures that will occur at specific sites. As such, it is not meaningful to discuss the uncertainty present in the simplified physical scenarios; rather, the test of their construction will be whether they prove useful to the agency as examples of how to evaluate sites in practice." One of the most difficult questions to be answered regarding a contaminated site is whether the contaminant concentration is uniform throughout the site; generally, it is not. As a result, numerous possibilities for differing extents of exposure exist. This draft document does not address the issue at all. 48. Page VII-2. The report states "Accordingly, variations among behavioral parameters are factored into the exposure scenarios presented." Many behavioral parameters change with age and with geographic location (meteorological conditions). Except for soil ingestlon by children, all exposure parameters have been based on a 70 kg man. 49. Page VII-2. The report states "Determining exposure requires use of measurement data and mathematical models. Uncertainty can be present in measured values that may not be accurate or representative, in mathematical models that do not reflect the processes actually occurring, and in parameters used in models which are also subject to measurement error." Much of exposure assessment is dependent upon site-specific Information. The use of measurement data whenever possible is far more powerful than the use of mathematical models. Thus, wherever possible, the use of mathematical models should be replaced by wp/6037r-78 �measurement data, e.g., TCDD levels 1n fish, pond sediment, soil on-s1te, soil off-site. 50. Page VII-4. The report states "The assessment, which 1s premised upon a thick layer of contaminated soil being present, assumed that no degradation occurred." The extent of exposure is influenced by the mode that a site 1s contaminated (being contaminated). If it is a continuous process, then the assumption that no degradation occurs is plausible. If the contamination was a one-time occurrence, then the assumption that no degradation occurs 1s implausible. How can the authors estimate exposure by inhalation to dusts and vapors and off-site if no degradation occurs? 51. Page VII-5. The report states "In summary it Is unlikely that on-site exposure estimates are in error to a large degree, but off-site exposures can be expected to show substantial site specific variation depending on soil concentration." Certainly when the on-site TCDD concentration is pre-selected and assumed to be uniform, there would be less error in the exposure estimates. In practice, the on-site TCDD concentration is not that well-defined and not uniform. 52. Page VII-8. The report states "The mixing depth was selected as 10 cm, which was judged to be intermediate to what might occur under different agricultural practices. A half-life of approximately 10 years was selected on the basis of experimental data from one study of 2,3,7,8-TCDO in surface soils." It is not clear why in some scenarios the environmental half-life is 10 years and in others it Is Infinite (no degradation). This needs further clarification. wp/6037r-79 �53. Page VII-19. The report states "Exposure duration set at 40 or 70 years 1s considered as a defined part of the exposure scenario, with other durations being easily evaluated if desired." It is not true that exposures to other durations can be easily evaluated. Many exposure parameters change with age. Except for soil ingestion, no other parameter has been derived for children. If exposure occurred when a child was 0-13 years old, how many exposure parameters presented in the draft document would apply? The effects of environmental half-life for different age groups can be dramatic (Paustenbach, 1987). 54. Page VII-20. The report states "The model is based on theoretical mass-balance calculations, utilizing equations for fundamental physical/chemical transport processes." The assumption that there is no degradation of TCDD in the environment is implausible when the document is estimating an off-site dilution factor, wind dispersion (and subsequent exposure to dusts by inhalation), vaporization (and subsequent exposure to vapors by inhalation), and other routes of "degradation." There does not appear to be a mass-balance in terms of ultimate exposure to TCDO. 55. Page VII-22: The report states: "Koc has not been measured for 2,3,7,8-TCDD and must Itself be calculated using an empirical relationship relating Koc to Kow, the octanol/water partition coefficient." wp/6037r-80 �Koc has been measured for TCDD for two types of clean, uncontamlnated soils (Marple et al_., 1987), and attempts have been made to measure Koc for several types of contaminated soils (Jackson et al_., 1986). While the regression equation of Lyman and Loretl was cited, the equation derived by Karickhoff et al_. (Mater Research. 13: 241-249, 1979) was not cited, and this equation produces a Koc value much closer to the experimental values for clean soils. 56. Page VI1-22. The report states: "Jackson et a]_. (1985) reported laboratory measurements of the soil/water partition coefficients for 10 soil samples from sites 1n Missouri and New Jersey . . . The measured partition coefficients (mean of "SWLP-R 5data) ranged from 4 x 104 to 4 x 106 with a geometric mean of 5 x 10 ." The data reported by Jackson suffer from the fact that the results are Internally inconsistent. For example, two values of leachate concentration of TCDD exceed the known water solubility. Moreover, concentrations of TCDD in both equilibrated phases (water and soil) were never measured, so that Koc values were determined from both measured and assumed values. Further, micellar solubilization from suspension of co-contaminants was not taken into account and this Invariable accounts for much of the spread in Koc values presented. These are just a few of the many faults in this work. In short, in light of these deficiencies, this paper would probably not be publishable using today's standards; at best, it probably presents the range within which the true Koc might reside. wp/6037r-81 �57. Page VII-22. The report states: "In light of the points raised above, the use of the selected value of Kd should be regarded as uncertain to two orders of magnitude." For clean soils, there Is less than one order of magnitude uncertainty in Koc according to values summarized by Marple et al_., (1987). 58. Page VII-25. The report states "Since this value is a factor of four below the more reliably established higher dose values, absorption (and thus exposure) may be underestimated by this factor." There are many problems associated with the use of the data presented in Poiger and Schlatter (1980) and they have been discussed elsewhere. 59. Page VII-26. The report states "Four of the five tested soils are in agreement with an absorption fraction of this magnitude." It is very unlikely that the GI absorption fraction of ingested fly ash Is in the same range as that of ingested soil. In fact, the available data suggest it is much less than soil. This area should receive some attention in order to address properly incinerator exposure scenarios. 60. Page VII-28. The report states "If Hawley's (1985) estimate that an adult ingests an average 0.060 mg/d of soil ..." It may only be a typographical error but, due to its importance, it is mentioned here. Hawley (1985) estimated an adult soil ingestion rate of 0.060 g/day rather than 0.060 mg/day. wp/6037r-82 �61. Page VII-30. The report states "A variety of other studies with chlorinated hydrocarbon compounds (reviewed In Fries, 1982), while not allowing comparisons between beef fat and milk concentrations 1n the same animals, do not suggest that the milk fat distribution ratios should be lower than the beef fat distribution ratios." There have been preliminary reports that TCOD levels in human milk fat are comparable to TCDD levels in body fat (Rappe et al_., 1984). If these reports are substantiated, It would preclude the use of PBB data on which the beef fat:so1l and dairy fat:soil distribution factors are currently based. 62. Page VII-35. The report states "Therefore the use of a single fish/sediment distribution ratio, as done in the fish pathway assessment, must be recognized as a broad approximation." This statement can be used for every mathematically modelled exposure parameter. This is why, if it 1s possible to obtain measurement data, such data should be substituted for values generated by mathematical models. 63. Page VII-35. The report states "The 6.5 g/d figure is based on data now over a decade old, and fish consumption may have risen somewhat In the intervening period, however this value still appears to be a reasonable typical value." The percentage of beef and dairy products Ingested that are home grown (home produced), on the other hand, was based on a USDA that is over 20 years old. These percentages probably have changed considerably over this period of time. Some have said that the national average may be about 20% of the figures used here. wp/6037r-83 �64. Page VII-45. The report states "Exposure to 2,3,7,8-TCDD through beef Ingestlon, dairy products ingestion, soil ingestion by children, and soil dermal contact (listed in decreasing order of estimated exposure) were evaluated using similar assumptions as in the land-related scenarios." A major unresolved issue is whether the bioavailability of TCDD on fly ash is truly much less than the bioavailability of TCDD on soil. As stated previously, all the data suggest that TCDD on fly ash is not very bioavailable. FRUIT AND VEGETABLE INGESTION This analysis is not presented in Table VI-4 because the available data are presumably conflicting. These data illustrate the need to interpret existing data in the other sections with caution. Some parameters in the other sections are based on little or no data, but because the data has not been contradicted (or confirmed), they are utilized. The authors of this draft document may have over-extended themselves in this regard. INCINERATOR EXPOSURE PARAMETERS The factors used to estimate exposure from TCDD emitted by incinerators is presented in Table VI-7 (p. VI-55). All the parameters except one listed in this table are the same as in Table VI-4 on which we have already commented. The one exception is the distance of the exposed population to the stack. The draft document used a distance of 0.8 km. While it 1s not wp/6037r-84 �Inconceivable to find rural households next to incinerators, it would be hard to believe that the number of people that fit this description is large, especially if this group is assumed to ingest home-grown beef and dairy products and fish from nearby ponds and streams! ALTERNATE SCENARIO/ALTERNATE APPROACH (a) One plausible scenario which should be considered is a community which was developed on an abandoned dump site. If TCDD were detected at this site, two different exposure assessments would be necessary. One would be a retrospective exposure assessment which would evaluate residents' past exposure and the other a prospective exposure assessment evaluating potential future exposure. (b) One major uncertainty would be determining the TCDD concentration throughout the community. Due to non-uniform distribution of contamination, especially considering the soil depth to which residents may be exposed, determination of the representative TCDD within the community may be extremely difficult. Another consideration is the assignment of an environmental half-life for TCDD in soil. According to the draft document, the use of a 10 year half- life, 29 year half-life or infinite half-life (no degradation), impacts exposure by less than a factor of 2 or 3. This is probably not true (see Paustenbach, 1987). wp/6037r-85 �(c) Once the TCDD concentration 1n soil 1s specified, an exposure assessment could essentially follow the approach In the draft document. However, the most plausible routes of exposure are expected to be by Inhalation, dermal contact, and soil Ingestlon. No contamination of food sources would be expected for sites similar to the one discussed above. (d) Exposure assessments should be conducted according to age. For purpose of a draft approach, exposure parameters for several age groups (e.g., 0-1, 1-6, 6-13, 13-70) may be reasonable. Parameters such as body weight, body surface area, Inhalation rates, and behavioral patterns of residents for the geographic location (meteorological conditions) In question can be determined. (e) Dust levels can be obtained from most locations In the U.S. and can be applied on a site-specific basis. Assigning a value for the level of inhalable dust of crustal origin can be estimated and may be more reliable than using wind dispersion models. Inhalation exposure to TCDD vapors can be modeled according to the approach outlined in the draft document. It is anticipated that the inhalation exposure route is de minimus when compared to exposure from dermal contact or soil ingestion. wp/6037r-86 �(f) Dermal contact with TCDD contaminated solid can follow the approach outlined in the draft document. Major uncertainties would be the bioavallabllity of TCDD from different types of soil. Additional research should be conducted to address the issue of how much soil o per cm Individuals may be "soiled", and the dermal absorption factor. Only the layer that is directly in contact can be absorbed. It should be determined experimentally using various uncontaminated soil types and human volunteers. An hourly rather than a daily rate of dermal absorption would be useful and should be assessed in experimental animals which best predict human dermal absorption. (g) Soil ingestion typically occurs from hand-to-mouth behavior, especially in older children and adults. One approach is to estimate the amount of soil on a fraction of one's hands that is ultimately ingested. This approach can be validated for toddlers by the data of Binder et. al_. (1986) and Clausing e_t aJL (1987). For older children and adults where no data exist, the same approach can be used, and when data become available, also be validated. (h) The above scenario may represent another "typical" scenario in addition to the ones proposed in the draft document. The above approach of estimating one's exposure should be considered because it attempts to utilize as much as possible site-specific Information and age-dependent physiological parameters. This will lead to better estimates of exposure. Wp/6037r-87 �ADDITIONAL RECENT PUBLICATIONS ON TCDD AND SELECTED EXPOSURE ASSESSMENT PUBLICATIONS AIHC (1984). Chemical carcinogens; Review of science and Us associated principles. AIHC (1985). AIHC Submissions to EPA on Risk Assessment Guidelines. Alzona, J., Cohen, B.L., Rudolph, H., Jow, H.N., and Frohllger, J.O. (1979). Indoor-outdoor relationships for airborne partlculate matter of outdoor origin. Atmos. Environ. 13:55-60. Bartek M.J., La Budde, 3.A. (1975). Percutaneous absorption In vivo. In Animal Models jn_ Dermatology, ed. H. Malbach, Churchill Livingstone, New York, pp. 103-120. Bartek, M.J., La Budde, J.A., Malbach, H.I. (1972). Skin permeability In vivo: Comparison 1n rat, rabbit, pig and man. J. Dermatol. Invest. 58, 114-124. Binder, S., Sokal, D., Maughan, D. (1986). Estimating soil Ingestlon: the use of tracer elements in estimating the amount of soil Ingested by young children. Arch. Environ. Hlth. 41(6):341-345. Bonaccorsi, A., diDomenico, A., Fanelli, R., Merli, F., Motta, R., Vanzati, R., and Zapponi, G.A. (1984). The influence of soil particle adsorption on 2,3,7,8-tetrachlorodibenzo-p-dioxin biological uptake in the rabbit. Arch. Toxicol, Suppl. 7:431-434. Branson, D.R., Takahashi, I.T., Parker, W.M. and Blau, G.E. (1985). Bioconcentration kinetics of 2,3,7,8-tetrachlorodibenzo-p-dioxin in rainbow trout. Environ. Toxicol. Chem. 4:779-788. Byard, J.L. (1987). The toxicological significance of TCDD and related compounds in human adipose tissue. Toxicol. Env. Hlth., (in press). Camoni, I., Di Muccio, A., Pontecorvo, D., Taggi, F., and Vergori, L. (1982). Laboratory investigation for the microbiological degradation of 2,3,7,8-tetrachlorodibenzo-p-dioxin in soil by addition of organic compost. In: Chlorinated dioxins and related compounds. Impact on the Environment. 0. Hutzinger, R.W. Frei, E. Merian, and F. Pocchiari, eds., Pergamon Press, New York, pp. 95-103. Centers for Disease Control (1986). Correlation between human serum and adipose tissue concentrations of 2,3,7,8-tetrachlorodibenzo-p-dioxin. wp/6037r-88 �Clausing, P., Brunekreef, B., Van Wijnen, J.H. (1987). A method for estimating soil Ingestlon by children. Int. Arch. Occup. Environ. Med., 59:73-83. Cockerham, L.G. and Young, A.L. (1982). The absence of hepatic cellular anomalies In TCDD-exposed beach mouse-a field study. Environ. Toxicol. Chem. 1:299-308. Cohen, A.F., and Cohen, B.L. (1980). Protection from being Indoors against Inhalation of suspended partlculate matter of outdoor origin. Atmos. Environ. 14:183-184. Crosby, D.G., Wong, A.S., Plimmer, J.R., and Wool son, E.A. (1971). Photodecompos1t1on of chlorinated d1benzo-p-diox1ns. Science 173:748-749. Crosby, D.G., Hollanen, K.W., and Wong, A.S. (1973). Environmental generation and degradation of dlbenzo dioxins and dlbenzofurans. Environ. Health Perspect. 5:259-266. Crunkllton, R.L., Smith, L.H., Petty, J.O., and Kleopfer, R.D. (1987). Residues of 2,3,7,8-tetrachlorod1benzo-p-d1ox1n 1n the Spring River, Missouri. Water, Air, Soil Pollut. 32:219-231. Crump, K.S. (1987). A critical evaluation of Sielken's dose response assessment for TCOD. Food Chem. Tox. (1n press). Day, J.P., Hart, M., and Robinson, M.S. (1975). Lead 1n urban street dust. Nature 253:343-345. di Domenlco, A., Silano, V, Vivlano, G., and Zapponl, G. (1980a). Accidental release of 2,3,7,8-tetrachlorodibenzo-p-dloxln (TCDD) at Seveso, Italy. II. TCDD distribution In the soil surface layer. Ecotoxlcol. Environ. Safety 4:298-320. di Domenlco, A., Silano, V, Vivlano, G., and Zapponl, G. (1980b). Accidental release of 2,3,7,8~tetrachlorod1benzo-p-dioxin (TCDD) at Seveso, Italy. IV. Vertical distribution of TCDD In soil. Ecotoxlcol. Environ. Safety 4:327-338. di Domenlco, A., Silano, V, Vivlano, G., and Zapponl, G. (1980c). Accidental release of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) at Seveso, Italy. V. Environmental persistence of TCDD In soil. Ecotoxlcol. Environ. Safety 4:339-345. y di Domenico, A., Silano, V, Vlviano, G., and Zapponi, G. (1980d). Accidental release of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) at Seveso, Italy. VI. TCDD levels 1n atmospheric particles. Ecotoxicol. Environ. Safety 4:346-356. wp/6037r-89 �d1 Domenico, A. and Zapponl, G.A. (1986). 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) In the environment: Human health risk estimation and Its application to the Seveso case as an example. Regulat. Toxicol. Pharmacol. 6:248-260. 01 Toro, D.M., Gens, J.S., Clarda, 0. (1985). Diffusion and partitioning of hexachlorobiphenyl in sediments. Environ. Sci. Technol. 19:1169-1176. Duggan, M.J. and Williams, S. (1977). Lead-in-dust in city streets. Sci. Total. Environ. 7:91-97. Eduljee, G. (1987). Chemosphere 16.907-20. Eschenroeder, A., Jaeger, R.J., Ospital, J.J., Doyle, C.P. (1986). Health risk analysis of human exposure to soil amended with sewage sludge contaminated with PCDD's and PCDF's. Vet. Hum. Toxicol. 28(5):435-442. Final Report of the Missouri Dioxln Task Force, October, 1983. Fries, G.F. (1987). Assessment of potential residues in foods derived from animals exposed to TCDD contaminated soil. Chemosphere, in press. Gehring, P.J. (1984). Background exposure to 2,3,7,8-tetrachlorodibenzo-pdloxin. In: Public Health Risks of the Dioxins, W.W. Lowrance, ed., William Kaufmann, Los Altos, CA. pp. 151-154. Graham, M., Hileman, F., Kirk, D., Wendling, J., Wilson, 3. (1985). Background human exposure to TCDD. Chemosphere, 14:6/7, 925-928. Graham, H.A., Hileman, F.D., Orth, R.G., Ryan, J.J., Sebaugh, J.L., Wendling, J.M., Wilson, J.D. (1987). Background concentration of TCDD and related compounds in adipose tissue in the North American population. Arch. Env. Contam. & Tox. (submitted). Graham, M., Hileman, F.D., Orth, R.G., Wendling, J.M., Wilson, J.D. (1986). Chlorocarbons in adipose tissue from a Missouri population. Chemosphere, 15:9-12, 1595-1600. Hardell, L., Domellof, L., Nygren, M., Hansson, M., Rappe, C. (1985). Levels of PCDD and PCDF in adipose tissue of patients with soft-tissue sarcoma or malignant lymphoma exposed to phenoxy acids and unexposed controls. American Chemical Soc., pp. 167-168. Hawley, J.K. (1985). Assessment of health risk from exposure to contaminated soil. Risk Analysis 5(4):289-302. wp/6037r-90 �ICRP, (1968). Report of Committee IV on evaluation of radiation doses to body tissues from Internal contamination due to occupational exposure, ICRP Publication 10. Pergamon Press, New York. Wester, R.C. and Noonon, P.K. (1980). Int. J. Pharmacol. 7:99. Ideo, G., Bellati, G., Bellobuono, et aj.. (1982). Increased urinary D-glucarlc add excretion by children living 1n an area polluted with TCDD. Clin. Chem. Acta 120:273-283. Ideo, G., Bellati, G., Bellobuono, A. and Blssantl, L. (1985). Urinary d-glucarlc add excretion 1n the Seveso area, polluted by tetrachlorodlbenzo-p-dloxin (TCDD): Five years of experience. Environ. Health Perspect. 60:151-157. Jackson, D.R., Rouller, M.H., Grotta, H.H., Rust, S.W., Warner, 3.3., Arthur, M.F., Deroos, F.L. (1985). Leaching potential of TCDD 1n contaminated soils. EPA/600/9-85/013 Apr. Jones, D., Safe, S., Morcom E., Coppock, C., and Ivie, W. (1986). B1oava1lab1l1ty of 2,3,7,8-tetrachlorod1benzo-p-d1ox1n administered to Holsteln dairy cows. Presented at 6th International Symposium on Chlorinated D1ox1ns and Related Compounds. September 16-19, 1986. Fukuoka, Japan. Jury W., Spencer, W., Farmer, W. (1984). J. Environ Quality 13,580. Kearney, P.C., Wool son, E.A., and Ellington, Jr., C.P. (1972). Persistence and metabolism of chlorodloxins In soils. Environ. Sci. Technol. 6:1017-1019. Kercher, J.R. and Anspaugh, L.R. (1984). Analysis of the NAEG model of transuranlc radlonucllde transport and dose. Lawrence Llvermore National Laboratory. Kimbrough, R., Falk, H., Stehr, P., Fries, G. (1984). Health Implications of TCDD contamination of residential soil. J. Toxlcol. Env. Health 14:47-93. Kuehl, D.W., Cook, P.M., and Batterman, A.R. (1986). Uptake and depuration studies of PCDD's and PCDF's 1n freshwater fish. Chemosphere 15:2023-2026. LaGoy, P.K. (1987). Estimated soil Ingestion rates for use in risk assessment. Risk Analysis (in press). Lee, L.E., Hobson, L.B. (1985). TCDD in body fat of Vietnam veterans and other men. In Chlorinated Dioxins and Djbenzofurans In the Total Environment n . e d- L - H - Keith, C. Rappe, G. Choudhary. pp. 205-214, . Butterworth, Boston. Leung, H-W, Paustenbach, D.J. A proposed occupational exposure limit for 2,3,7,8-TCDD. J. Amer. Indust. Hygiene Assoc. (submitted). wp/6037r-91 �MacKay, D., Powers, B. (1987). Chemosphere 16, 745-57. Harple, L, Berridge, B., Throop, L. (1986a). Measurement of the water octanol partition coefficient of TCOD. Environ. Sci. Technol. 20(4):397-399. Marple, L., Brunck, R., Throop, L. (1986b). Water solubility of 2,3,7,8-tetrachlorodibenzo-p-dioxin. Env. Sci. Technol. 20:180-182. Harple, L., Brunck, B., Berridge, B., Throop, L. (1987a). Comparison of experimental and calculated physical constants for TCDD. In: Solv. Haz. Waste Prob., Ed. J. Exner, ACS. Harple, L., Dei Rossi, D., Throop, L. (1987b). Removal of TCOD from wastewater and wellwater by coagulation and flocculation with aluminum salts. In: Solv. Haz. Waste Prob., Ed. J. Exner, ACS. Hiller, M.H., Wasik, S.P., Huang, G-L., Shiu, W-Y., and Hackay, D. (1985). Relationships between octanol-water partition coefficient and aqueous solubility. Environ. Sci. Technol., 19, 522-529. Hocarelli, P., Marocchi, A., Brambilla, P., Gerthoux, P.M., Young, D.S., Mantel, N. (1986). Clinical laboratory manifestations of exposure to dioxin in children. JAMA, 256:19, 2687-2695. HAS (1983). Risk assessment in the Federal Government: managing the process, Hatl. Acad. Press. HAS (1980). Lead in the human environment. Washington, D.C., National Academy Press. Niimi, A.J. and Oliver, B.G. (1986). Biological half-lifes of chlorinated dibenzo-p-dioxins and dibenzofurans in rainbow trout (Salmo gairdneri). Environ. Toxicol. Chem. 5:49-53. Norris, L.A. (1981). The movement, persistence, and fate of the phenoxy herbicides and TCDD in the forest. Residue Rev. 80:65-135. Nygren, M., Hansson, M. Rappe, C., Dommellof, L., Hardell, L. (1985). Analysis of PCDD and PCDF in adipose tissue from soft-tissue sarcoma patients and controls. ACS Meeting, pp. 160-163. Ontario Ministry of the Environment (1985). Scientific criteria document for standard development - PCDD's and PCDF's. OME, 4-84. Ono, M. Wakimoto, T., Tatsukawa, R. (1986). PCDD and PCDF in human adipose tissues of Japan. Chemosphere 15:1629-1634. wp/6037r-92 �Palausky, J., Harwood, J.J., Clevenger, T.E., Kapila, S., and Yanders, A.F. (1986). Disposition of tetrachlorod1benzo-p-diox1n In soil. In: Chlorinated Oloxlns and Dibenzofurans 1n Perspective, C. Rappe, 6. Choudhary, and L.H. Keith, eds., Lewis Publishers, Inc.pp. 211-223. Patterson, O.G., Jr., Holler, J.S., Smith,. S.J., Llddle, J.A., Sampson, E.J., and Needham L.L. (1986a). Human adipose data for 2,3,7,8-tetrachlorodibenzop-d1ox1n 1n certain U.S. samples. Chemosphere 15, 2055-2060. Patterson, O.G., Jr., Hoffman, R.E., Needham, L.L., Roberts, D.W., Bagby, J.R., Pirkle, J.L., Falk, H., Sampson, E.J., and Houk, V.N. (1986b). 2,3,7,8-tetrachlorod1benzo-p-d1ox1n levels In adipose tissue of exposed and control persons In Missouri. J. Amer. Med. Assoc. 256, 2683-2686. Paustenbach, O.J., Shu, H.P., Murray, F.J. (1986). A critical examination of assessments of the health risks associated with TCDD 1n soil.. Reg. Toxlcol. Pharmacol., 6, 284-307. Paustenbach, D.J. (1987). Assessing the potential environment and human health risks of contaminated soil. Comments Toxlcol. 1(3-4): 185-200. Pennington, J.A.T. (1983). Revision of the total diet study. Food list and diets. J. Am. Diet. Assoc. 82:166-173. Philipp, M., Krasnobajew, V., Zeyer, J., and Hutter, R. (1981). Fate of TCDD in microbial cultures and in soil under laboratory conditions. FEMS Symp. 12:2210-2233. Pitot Committee Report (1986). Dioxin "update" Committee, convened by EPA, July 1-2., 1986. Podoll, R.T., Jaber, H.M., Mill, T. (1986). Tetrachlorodibenzodloxin: rates of volatilization and photolysis in the environment. Environ. Sci. Technol., 20, 490-492. Poiger, H. and Schlatter, C. (1986). Pharmacokinetics of 2,3,7,8-TCDD in man. Chemosphere 15:1489-1494. Ryan, J.J., Lizotte, R., and Lau, B.P-Y. (1985a). Chlorinated dibenzo-p-dioxins and chlorinated dibenzofurans in Canadian human adipose tissue. Chemosphere 14, 697-706. Ryan, J.J. (1986). Variation of dioxins and furans in human tissues. Chemosphere 15, p. 1585-1593. Ryan, J.J. and Schecter, A. (1985). Distribution of dioxins and furans in human autopsy tissues from the general population. Preprint Extended Abstract, presented at the American Chemical Society Meeting, Miami, pp. 158-159. wp/6037r-93 �Ryan, J.J., Schecter, A., Lizotte, R., Sun, W-F., and Miller, L. (1985b). Tissue distribution of dioxins and furans in humans from the general population. Chemosphere 14, 929-932. Ryan, J.J., Williams, D.T., Lau, B. P-Y., Sakuma, T (1985c). Analysis of human fat tissue for 2,3,7,8-tetrachloro-dibenzo-p-dioxin and chlorinated dibenzofuran residues. In Chlorinated Dlgxjns and Pibenzofurans in the Total Environment II (L.H. Keith, C. Rappe, and G. Choudhary, Eds.)i PPi- 205-214. Butterworth, Boston. Schaefer, V.J. Mohnen, V.A., and Veirs, V.R. (1972). Air Quality of American Homes. Science 175:173-175. Schecter, A., Ryan, J.J., Lizotte, R., Sun, W-F., Miller, L., Gitlitz, G., and Bogdasarian, M. (1985). Chlorinated dlbenzodioxins and dibenzofurans in human adipose tissue from exposed and control New York State patients. Chemosphere 14, 933-937. Schaum, J. (1984). Risk analysis of TCDD contaminated soil. EPA. Shu, H.P., Paustenbach, D.J., Murray, F.J. (1987a). A critical evaluation of the use of mutagenesis, carcinogenesis and tumor promotion data in a cancer risk assessment of TCOD. Reg. Tox. Pharmacol. 7:57-88. Shu, H., Paustenbach, D., Murray, F.J., Marple, L., Brunck, B., Dei Rossi, D., Teltelbaum, P. (1987b). Bioavailability of Soil-Bound TCOD; Oral Bioavallability in the Rat. Fundam. Appl. Toxicol. (submitted) Shu, H., Teitelbaum, T., Webb, A.S., Marple, L., Brunck, B. Dei Rossi, D., Murray, F.3., Paustenbach, D. (1987c). Bioavailability of Soil-Bound TCDD: Dermal Bioavailability in the Rat. Fundam. Appl. Toxicol. (submitted) Sielken, R.L. (1987a). Quantitative cancer risk assessments for TCDD. Food and Chem. Tox., 25(3):257-267. Sielken, R.L. (1987b). A response to Crump's evaluation of Sielken's dose-response assessment for TCDD. Food Chem. Tox. (in press). Sielken, R.L. (1987c). Statistical evaluations reflecting the skewness 1n the distribution of TCDD levels in human adipose tissue. Chemosphere (in press). Spencer, W.F. and Farmer, W.J. (1980). Assessment of the vapor behavior of toxic organic chemicals. In: Dynamics, Exposure and Hazard Assessment of Toxic Chemicals, R. Hague, (ed.), Ann Arbor Science, pp. 143-161. Stanley, J.S., Boggess, K.E., Onstot, J., Sack, T.M., Remmers, J.C., Breen, J., Kutz, F.W., Carra, J., Robinson, P., and Mack, G.A. (1986). PCDDs and PCDFs in human adipose tissue from the EPA FY82 NHATS repository. Chemosphere 15, 1605-1612. wp/6037r-94 �Steinberg, K.K., MacNeil, M.L., Karon, J.M., Stehr, P.A., Neese, J.W., Needham, L.L. (1985). Assessment of TCDD exposure using a modified D-glucaric acid assay. J. Toxicol. Env. Health, 16:743-752. Syntex Agribusiness, Inc. (1987). Comments on EPA document, "Public Comment Draft Feasibility Study" for Times Beach, Missouri. Travis, C.C., Richter, S.A., Crouch, E.A.C., Wilson, R. t and Klema, E.O. (1987). Cancer risk management. Environ. Sci. Technol. 21:415-420. Umbreit, T.H., Hesse, E.J. and Gallo, M.A. (1986a). Comparative toxicity of TCDD contaminated soil from Times Beach, Missouri, and Newark, New Jersey. Chemosphere 15:2121-2124. Umbreit, T.H., Hesse, E.J., Gallo, M.A. (1986b). Bioavailability of dioxin in soil from a 2,4,5-T manufacturing site. Science, 232, 497-499. USEPA (1985a). Superfund health assessment manual. USEPA (1987). Public comment draft feasibility study, Times Beach site. van den Berg, M., De Vroom, E., Van Greevenbroek, M., 01ie, K., and Hutzinger, 0. (1985). Bioavailability of PCDDs and PCDFs adsorbed on fly ash in rat, guinea pig and Syrian golden hamster. Chemosphere 14:865-869. Wester, R.C., and Noonan, P.K. (1980). Relevance of animal models for percutaneous absorption. Int'l. J. Pharmaceut. 7:99-110. Wester, R.C. and Maibach, H.I. (1983). Cutaneous pharmacoklnetics: 10 steps to percutaneous absorption. Drug Metab. Rev. 14:169-205. Wester, R.C. and Maibach, H.I. (1975). Percutaneous absorption in the Rhesus monkey compared to man. Toxicol. Appl. Pharmacol. 32:394-398. Wrenn, G.C. (1986). Testimony of Grover C. Wrenn - asbestos ban and phaseout proposal. EPA. Young, A.L. (1983). Long term studies on the persistence and movement of TCDD in a national ecosystem. In: Human and Environmental Risks of Chlorinated Dioxins and Related Compounds, R.E. Tucker, A.L. Young, and A.P. Gray (eds.), Plenum Press, New York, pp. 173-190. Young, A.L. (1984). Determination and measurement of human exposure to the dibenzo-p-d1oxins. Bull. Environ. Contam. Toxicol. 33:702-709. Young, A.L., Cockerham, L.G., Thalken, C.E. (1986). A long-term study of ecosystem contamination with TCDD. 6th Dioxin Symp, Fukuoka, Japan. wp/6037r-95 � 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. 5530 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>Syntex (U. S. A.), Inc. Date A point or period of time associated with an event in the lifecycle of the resource 1987 Title A name given to the resource Comments to the EPA Draft Document "Estimating Exposures to 2,3,7,8-TCDD" (June 1987) ao_seriesVIII