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                  <text>&lt;p style="margin-top: -1em; line-height: 1.2em;"&gt;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.&lt;/p&gt;&#13;
&lt;p&gt;For more about this collection, &lt;a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a"&gt;view the Agent Orange Exhibit.&lt;/a&gt;&lt;/p&gt;</text>
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                <text>Bedell, Robert P.</text>
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                <text>&lt;strong&gt;Corporate Author: &lt;/strong&gt;Executive Office of the President, Office of Information and Regulatory Affairs</text>
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                <text>Letter: from Robert P. Bedell to Dominick Onorato, April 25, 1984.</text>
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                <text>Vietnam Experience Twin Study</text>
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                    <text>Item ID Number

00578

Author

Custis, Donald L

Corporate Author
Report/Article TltlB Typescript: Statement of Donald L. Curtis, M.D., Chief
Medical Director, Department of Medicine and Surgery,
Veterans Administration, Before the Subcommittee on
Oversight and Investigations, Committee on Veterans'
Affairs, House of Representatives, September 15,1982

Journal/Book Title
Year
Month/Day
Color
Number of Images
DeSCrlptOII NotOS

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20

Alvin L Your|

gfiled tnis item under the category
"Human Exposure to Phenoxy Herbicides and TCDD"

Tuesday, February 20, 2001

Page 578 of 680

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DONALD L.CUSTIS.M.D.,

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DEPARTMENT OF MEDICINE AND SURGERY

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SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS,
COMMITTEE ON VETERANS'AFFAIRS
HOUSE OF REPRESENTATIVES

September 15, 1982
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Mr. Chairman and Members of the Committee:
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Good morning.

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On behalf of the Veterans Administration, we are pleased to have the

Opportunity to appear before you today to provide an update on the status of both VA's
Agent Orange-related activities and the Readjustment Counseling Program.

We are

continuing efforts to resolve the complex medical and scientific questions concerning
Agent Orange. In the interim, we are providing medical care and treatment, as well as
information to Vietnam veterans. We believe that a great deal of progress has been
mode in both areas since we last appeared before this committee on May 6, 1981.

Mr. Chairman, we are aware that both the Agent Orange issue and readjustment to
civilian fife remain key concerns for many Vietnam veterans. A great deal still needs to
be done to resolve both of these concerns.

Let me reemphasize, however, that the

Veterans Administration has never lost sight of the special needs of the Vietnam veteran.

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Aoent Oronge Program
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On June 30, 1982, Robert P. Nimmo, Administratpr
approved a revised Department of Medicine and Surgery program of Agent Orangerelated activities. The most significant activity which was approved is a pilot study as a
preliminary to the full epidemiological study provided for by Congress. Other major
efforts included are the Vietnam veterans identical twin study, a mortality study, and
specially-related research projects.

Approval was also given for the establishment of the Agent Orange Projects Office
within the Department of Medicine and Surgery. This office will coordinate and monitor
a variety of epidemiological projects.

Efforts are now underway to identify key

epidemiologic staff who will be responsible for these efforts.

The core staffing will

consist of an Epidemiologist, Biostatistician, Statistical Programmer, Health Science
Specialist for Quality Assurance, on Administrative Assistant and supporting clerical
staff.

In addition, approval was given for continuation and improvement of the Agent Orange
Registry, chloracne activities, a follow-up to the literature analysis, a monograph series,
establishment of a Vietnam service indicator in the Patient Treatment File (RTF), and a
retrospective study of dioxins and furans in human adipose tissue.

STATUS OF VA EPIDEMIOLOGY STUDY;

The epidemiology protocol submitted to the VA by the UCLA School of Public Health on
April 29, 1982, has now been reviewed by the VA Advisory Committee on Health-Related

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Effects of Herbicides, the Agent Qronge Working Group (AOWG) and the Office of
Technology Assessment. The protocol is currently being reviewed by a committee of the
.Academy of Sciences (MAS). The VA has been advised that HAS is now in the
jes of this review process. It |s expected that the report will be completed and

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forw.a/jted to. tjh$ Veterans Administration shortly*

Following incorporation of the

.yarjous ^eYlewers/ comments, we will solicit bids for a contract for the conduct of a pilot

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study. We anticipate having that solicitation in place before this December.

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The purpose of the pilot.study w|U be to permit us to "fine-tune" the protocol for the
conduct of the frjll-^cale epidemiology study which will study a population of
approximately 18,000 veterans. The pilot study has become the focal point of recent
activity by the VA, the Army Agent Orange Task Force (AAOTF) and the AOWG.

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The AOWG has appointed a subcommittee of its Science Panel to establish procedures
for cohort selection for the epidemiology pilot study.

The VA has brought in

bipstatistica) consultants to work with this subcommittee and with the AAOTF.

The

Subcommittee is now in the process of preparing its final report to the Science Panel.

Health Care

Tr« Veterans, Administration is implementing the medical core and treatment provisions
of Public Low 97-72, the "Veterans' Health Care, Training, and Small Business Loan Act
of 1^81." Shortly after the law was signed, interim guidelines for the implementation of
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published In in the Federal Register on December 5, 1981, to provide Vietnam veterans
and the general public with the opportunity to comment.

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Under the provisions of the guidelines, each veteran who served in the Republic of
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Vietnam and who requests VA medical care Is being provided a complete medical history,
physical examination and appropriate diagnostic studies/When it is determined that a
condition

exists requiring treatment, the responsible staff

physician makes a

determination as to whether the condition resulted from a cause other than the specified
exposure to Agent Orange. The guidelines include a description of those conditions
which I determined cannot ordinarily be considered to be due to such exposure.
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Ultimately, it is left to the treating physician to exercise professional judgment in
determining whether the veteran should be provided care under this authority.

Agent Orange Registry
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Since the initiation of the Agent Orange Registry in 1978, approximately 91,000 veterans
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have received an Agent Orange examination at VA health care facilities. The VA has
provided approximately 20,000 follow-up examinations for Agent Orange.

The basic

registry process involving a comprehensive physical examination, completion of a
questionnaire and informing the veteran of the results of the examination verbally and in
writing, are continuing to be followed by all health care facilities.

The monthly report, transmitted by VA health care facilities and compiled at VA Central
Office, is still an effective tool in measuring the numbers of examinations (initial and
follow-up) being performed at the facilities and the number of pending examinations.
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The4 Environmental Medicine Office is continuing to monitor the numbers of pending
examinations to assure that the veteran is provided the Agent Orange examination and
related treatment in a timely manner. Facilities reporting •Vjut-of-line" situations, that
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is, facilities with examinations pending more than 30 days or having more than 50

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examinations pending during any reporting period ore contacted by program officials at

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V^A Central Office and directed to'take Immediate action to reduce the number of
pending examinations to comply with Central Office guidelines.
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'Improvements In our registry procedures will enable the VA to match Agent Orange
Registry records with records of hospitalization in the Patient Treatment File (PTF)
system so that correlations can be made regarding the types of diagnoses Vietnam
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veterans are fpresenting forf treatment at VA health care facilities.
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The VA is cooperating with the Department of Defense with regard to Agent Orange
examinations for active duty personnel. Instructions will be mailed to all VA health care
facilities for processing an active duty service member's request for an examination and
for processing the forms. The results from this examination will be entered into the
Agent Orange Registry.

Twins Study

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The VA has recently given approval for the development of a comprehensive protocol

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that will involve studying identical twins. The proposed study would involve identical
twin veterans where one twin served In Vietnam during the period of Herbicide Orange
spraying and where the twin sibling did not serve in Southeast Asia. This study will be
designed to investigate whether the current psychological and physical health of Vietnam
veterans was adversely affected by their military experience in Vietnam.

Veterans

Administration researchers at our St. Louis VA Medical Center have proposed the study
and ore currently developing the protocol. We would anticipate that If the protocol
survives the scrutiny of appropriate scientific reviews, we will launch into the physical
examinations of some 450 pairs of identical twins in late 1983 and should have an initial
report of findings by October 1984.
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A carefully-designed and well-executed mortality analysis of Vietnam" veterans will
provide background to many questions raised by the Agent Orange exposure issue in
particular as well as the possible health effects of service in Vietnam in general,

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Vietnam Mortality Study is designed to analyze and compare cteatH rates arid cause-ofdeath profiles of veterans with service in Vietnam and comparable veterans with no
service in Vietnam.

The studies will use existing computer records to assemble a cohort of veterans and
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determine their mortality experience. It should be noted that the mortality studies will
provide mortality information which may prove useful primarily in suggesting areas for
further scientific study. These mortality studies will be conducted by researchers at the
Veterans Administration Central Office in Washington, DC. The collection and coding of
death certificates and the abstracting of military records will be done by VA
contractors. We are currently evaluating submitted proposals and hope to sign contracts
for these efforts shortly. It is anticipated that it will take approximately two years to
complete the mortality studies.

Retrospective Study of Dioxins and Furons in
"Adipose Tissue of Vietnam-Era Veterans
The Environmental Protection Agency has been collecting adipose tissue from the U.S.
general population.

This National Adipose Tissue Bank was initiated in 1968 and now contains specimens
from approximately 6,000 individuals. Represented within this bank is adipose tissue
from approximately 3dO males born between 1938 and 1952.

It is estimated that

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approximately 200 of these males may have served in the U.S. military during the
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Vietnam"erei and that as many as 70 may have lervecl in Vietnam.

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"We are currently developing an agreement by which the VA would support an interogency
iludy to be conducted at theJ^PA 6ioxin Laboratory in Bay St. Louis, Mississippi. This
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will be a retrospective study of chlorinated aioxins and furans in human adipose tissue.
The study is designed to establish 'background levels of 2, 3, 7, 8-TCDD in the U.S. male
population. In addition, this study may serve as a means of determining whether service
in the military and especially in Vietnam has had an effect on the levels of TCDD in the

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develop the research protocol and appropriate sampling and analytical methods. The
actual analyses of the human tissues will be costly and time consuming. Data should be
forthcoming within two-three years.
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Chloracne Activities

The review of skin conditions to identify questionable cases which may be chloracne is
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continuing.

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Over 3,200 Rating Decision Sheets on skin condition claims have been

reviewed by VA Central Office physicians. The medical records of questionable cases
were reviewed by a dermatologist consultant at the Washington VA Medical Center who
tentatively identified 12 cases requiring a further clinical review which will include a

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physical examination of those individuals.

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We are now In the process of making arrangements for the physical examinations,
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including dermatology examinations, of these individuals at selected non-VA clinics. I

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anticipate that these examinations will be conducted during October.

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We intend to continue our review of Rating Decision Sheets provided by VA Central
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recommend selected claimants for special dermatojogical examination. Additionally, we
will review and analyze Agent Orange Registry data relating to types of skin conditions
being reported by participants.

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I am confident that our current emphasis on chloracne-related activities will assist us in
more effectively identifying and treating skin conditions which may be the result of
exposure to Agent Orange.

Vietnam Service Indicator for Patient Treatment File

The Patient jreatment File (PTF) maintained by the Department of Medicine and
Surgery has great potential for epidemiological research related to Vietnam veterans. A
major problem with this automated, file is that there has been no entry to identify those
veterans who actually served in Vietnam.
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The establishment of such an indicator, in most instances, will require a hand search of
the individual veteran's service record. This would best be accomplished by a contract
with an organization which has a proven record of expertise with this type of effort.
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We intend to conduct a study to determine the feasibility and cost of obtaining a
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veteran's service history. Based upon the results obtained, we will then decide whether
to obtain this information for all Vietnam-era veterans in the PTF.

�Speciolly-Solicited Reseorch Activities

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Medical Research Services has recently approved 10 new Agent Orange research studies
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components of Agent Orange. Two other ongoing studies address these issues also. The
Studies include analysis of the impact of Agent Orange components on:

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biological system to one or more components of Agent Orange, and subsequently
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measuring abnormalities of biological function.
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The chemicals used in these experiments which are the main component parts of Agent
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Orange are: 2.4-dichlorophenoxyacetic acid (2,4-D) and 2,4,5-trichiorophenoxyocetic

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acid (2,4,5,-T). In addition to these chemicals, Agent Orange (and some other herbicides
used less frequently in Vietnam) contained varying amounts of a contaminant commonly
referred to as TCDO (dioxin) which will also be a focus of studies to determine whether
and how delayed toxicity is manifested after low-dose exposure. Such studies may
provide clues for clinicians as to what medical tests would best identify delayed, toxic
effects, if any, of exposure of veterans to herbicides in Vietnam.

The biological systems thought to be affected by exposure to TCDD are:

6

Liver function; When animals are exposed to TCDD and related compounds,
these chemicals are stored in the liver and produce acute liver damage. It

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would appear likely that any delayed harmful effects of exposure to low closes
of »uch compounds would be manifested by subtle changes fn the biochemistry
•«f the liver.

Seven of the funded research studies will investigate the

delayed impact of exposure to

Agent Orange components and the

contaminant TCDD on various aspects of liver cell functions in a variety of
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Skin: Chloracne is the one documented effect of low-dose exposure to Agent
Orange in humans. One study will analyze the underlying biochemical events
that lead to ch lor acne in a mouse model and in human tissue culture cells.

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the nervous systems: Acute accidental poisoning with TCDD in man has led
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to a variety of usually-acute neuromuscular abnormalities. Four studies will
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systematically investigate the effect of the components of Agent Orange on
neuromuscular function, sleep and behavior in a variety of animal models.

A new effort to solicit and support research on the special health problems facing
Vietnam veterans has just begun.

The Research and Development Office has sent

forward to all VA medical facilities a solicitation for research studies dealing with
disorders affecting Vietnam veterans and their families.

It is anticipated that a

significant number of new studies submitted in response to this solicitation will be
supported in Fiscal Year 1983.

• • - • - - • . • • &gt; ' • . ..

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Monograph Series
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Funding has been provided during FY 1982 for the preparation of a monograph series
designed to provide useful scientific information on environmental factors that may have
affected the'health of military personnel serving in Vietnam.

�II.

-&amp;#!^^^ ore planned on the following subjects:
Monographs
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Literoture Anolysis

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chloracne, birth defects and genetic
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Mr. Chairman, as you may know, the comprehensive literature review of worldwide
scientific literature on Agent 6range and other phenoxy herbicides used in Vietnam has
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been completed in accordance with the provisions of Public Law 96-151,
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distributed this two-volume report (which includes an annotated bibliography and analysis
of1,200i scientific papers)^widelyWithin imeVA.

Copies have also been provided .to rnembers of the White-House established Agent
Orange Working Group, the Advisory Committee on Health-Related

Effects of

Herbicides, the National Academy of Sciences, the Office of Technology Assessment, the
Departments of Agriculture and Defense, Surgeon General of the U.S. Air Force, Library
of Congress, the Centers for Disease Control and other individuals, organizations, and
scientific research groups. The successful completion of this review represents a step
forward on the Jong road to understanding the complex health issues related to the use of
herbicides.

It will undoubtedly serve as an invaluable scientific resource which will

assist scientists and others in identifying areas suitable for additional research.

We jntend to periodically update this report and to augment it with a detailed critical
assessment of all publications addressing herbicide exposure with particular emphasis on
health consequences in humans.

It is estimated that about 400 publications have

appeared since October 1981. A critical review of these recent reports is needed in
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order to keep this effort current. The Veterans Administration will take necessary steps
to ensure that the literature review and analysis remains as current as possible.

�12.
Armed Forces Institute of Pathology (AFIP)

The Veterans Administration Is continuing to cooperate with the Armed Forces Institute
of Pathology in providing biopsy and autopsy materials for analysis to the Institute. This
special registry was established in 1978 with the purpose of analyzing tissue samples to
determine what diseases Vietnam veterans are suffering from, as reflected in biopsies or

The VA has repeatedly emphasized the importance of the AFIP Registry and will
continue to urge VA health care facilities to send pathological material obtained from
any Vietnam veteran.

.

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Education Activities

Mr. Chairman, our environmental physicians, as Agent Orange coordinators at our major
VA health care facilities, remain the key link in examining and advising the veteran
concerned about exposure to Agent Orange. In order to ensure that these health care
staff remain completely abreast of the latest developments, nationwide conference calls
ore held on a regular basis. When required, special conference calls are scheduled on
significant developments requiring their immediate attention.

In addition to the conference calls, relevant Agent Orange-related literature is
periodically sent to the immediate attention of environmental physicians. Staff support
within the Environmental Medicine Office is available to assist in the explanation of
.specific documents. or to answer questions which may be raised by the information
received from VA Central Office.

�13.

Environmental physicians ore encouraged to participate in important scientific meetings

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I&lt;in Ag«nt Orange and other environmental substances in order to keep abreast of
scientific «nd medical developments.

Members of our own VA Central Office staff

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played a key role In the planning and organizing of an "International Symposium on
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.Chlorinated Dioxins and Related Compounds" which was held in Arlington, Virginia, on
October 25-29, 1981. On October 12-1 A, 1982, Or. Barclay M. Shepard, my special
assistant, and Dr. Alvin L. Young will actively participate in the "3rd International
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Symposium on Chlorinated Dioxins and Related Compounds" which will be held in
Salzburg, Austria. ) hove been advised that several of our environmental physicians are
/also planning to attend. Through such participation I am confident that our health care
'ftaff will remain professionally current with the latest findings on the short and longrange effects of Agent Orange and other environmental substances.

VA Public information Activities

As part of our effort to inform Vietnam veterans, their families, and other concerned
individuals and organizations about Agent Orange and the assistance provided by the VA,
we produced and distributed to all VA field stations a videotape entitled "Agent Orange:
'&lt; A Search for Answers."

'* • ,

While a recent internal survey indicated that many thousands of people have viewed the
program on television or in numerous groups of individual showings, we are encouraging
grepter use of the film.

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We are very pleased to report that this videotape has received considerable acclaim from
critics.

The Health Education Communication Association and the Network for

Continuing Medical Education presented an award of merit to the VA for Outstanding

�14.
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ochievement in the use of television for education in the health sciences."

The

International Television Association (ITVA) awarded its Golden Reel of Excellence for
the vltteotape's "highly-effective form of communication, which helped Ifie user
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organization better achieve its stated goals." the program also was cited by ITVA for
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creativity, innovative techniques, and high-production value. In addition, the program
also received an Emmy Award from the National Academy of television Arts and
Sciences.

We are delighted by this recognition and encourage all interested individuals to view this
program.
*

The VA takes seriously its obligation to keep veterans informed about Agent Orange. We
have also pursued other avenues to provide information and education to concerned
Vietnam veterans and their families and VA employees on matters related to Agent
Orange.

.

Early this year, an automated mailing list was developed from the Agent Orange
Registry. In June, letters were sent to these veterans along with the first two of a new
series of printed information material on Agent Orange. One of these pamphlets was
devoted primarily to Public Law 97-72. A third pamphlet has been issued and a fourth is

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in production.

VA officials have participated in public seminars, news media interviews and other public
forums dealing with the subject of Agent Orange.
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VA Liaison with State Agent Orange Activities

At the present time, 18 states have initiated programs directly related to the Agent
Orange issue.

The VA is continuing its efforts to maintain an effective, ongoing

�15.
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relationship with each of these state programs. One of the prime responsibilities of our
Agent Orange Research and Education Office is to insure that current and accurate
information regarding VA Agent' Orange-related activities is disseminated on a timely
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basis to the various states,' as well as to veteran service organizations, government
agencies, and interested parties. We consider }t to be an essential part of our program to
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fully Informed both with regard to the current body of knowledge regarding the possible
adverse effects of dioxins, as well as the status of VA Agent Orange programs.

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To this end, the VA has provided the states with copies of all pertinent Agent Orange
materials and we have extended to officials from all of these states an open invitation to
attend the VA Advisory Committee meetings. Several of the states sent delegations to
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the meeting held on August 31.

The efforts are of a continuous nature and are beneficial to all concerned parties. As
new states become involved in the Agent Orange issue, VA will include them in its
information exchange program.

White House Agent Orange Working Group (AOWG)

We are pleased to report that the Veterans Administration is continuing to play an active
role in the White House Agent Orange Working Group and its Science Panel.

This committee was established in July 1981 when the Interogency Group to Study the
Possible Long-Term Health Effects of Pnenoxy Herbicides and Contaminants was
expanded and elevated in status to the Cabinet Council level.

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The AOWG brings together policy officials and scientists from throughout the federal
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Departments of Defense, Agriculture, and Labor, Environmental Protection Agency,
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The AOWG has been very helpful to the VA in the review of our planned epidemiological
study, mortality study, and other important research efforts.

Through the AOWG

mechanism, the VA also has been able to contribute to the success of Agent Orange
research efforts conducted or sponsored by other federal departments and agencies. The
more important of these research efforts are the U.S. Air Force's "Operation Ranch
Hand" study and the Centers for Disease Control's Birth Defects Study.

We view our participation as vital to the scientific process and as fully consistent with
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are available to support the working group's continuing efforts."

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Advisory Committee on Health-Related Effects of Herbicides

This committee, established in 1979, continues to meet quarterly at VA Central Office
for the purpose of assembling and analyzing information which the VA needs to
formulate medical policy and procedures on"the complex questions surrounding veterans'
herbicide exposure.

�17.

During recent meetings the committee has discu&amp;sed the VA epidemiological study and
herbicide Ijterdture review,' the VA-*olicited in-house research program regarding Agent
1
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Orange and Agent Blue, the VA mortality study, international dioxin symposiums, the Air
Force t^ealth'Study, the CDC Birth Defects &amp;udy, the proposed VA Twin Study/the
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activities and rrtottersdf concern to Vietnam veterans dnd scientists searching for
answers to the (difficult qUeirfions1 raised oi&gt;obt'the possible human health effects of
herbicides.
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The committee 'has been particularly helpful in advising the VA on the literature review
and the epidemiological study. The literature review, published October 1981, was the
subject of several sessions and considerable time and attention have been devoted to a
critique of the proposed epidemiological study design.

Verbatim transcripts are prepared and made available to appropriate government offices
and interested organizations and individuals. A copy of each transcript also is sent to all
environmental physicians.

;

;:;

Policy Coordinating Committee

In recognition of the importance of the Agent Orange issue, the Administrator has
reorganized and elevated in status the Policy Coordinating Committee (PCC) which was
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thCjAgency's central coordinating point for Agent-Orange related activities. The PCC
develops policy for review and approval by the Administrator. It now is composed of the
top leadership of the major departments and staff offices within the VA. Mr. Everett
Alvarez, Jr., Deputy Administrator, chairs the PCC.

�18.
I wish to conclude this port of my testimony on Agent Orange, Mr. Chairman, by again
expressing the total commitment of the Veterans Administration to attempting to
resolve the many issues relating to Agent Orange. Although there is no way that we, or
anyone, can guarantee that ultimate and conclusive answers will be found to the
extremely-complex medical and scientific issues stemming from the use of the defoliant
Agent Orange in Vietnam, nevertheless, we will continue to vigorously pursue the search
for those answers. These efforts will center not only on our own research initiatives, but
will be closely interfaced with the intensive research now underway by other federal,
public and private institutions.

Readjustment Counseling

The Vietnam-era Veterans Readjustment Counseling Program has seen a number of
important developments in recent months.

In January, the Veterans Administration vested responsibility for this program in a new
independent professional service—the Readjustment Counseling Service—and established
that service on the same administrative level as Medical, Surgical, Nursing, Prosthetics,
etc.

A new program director was appointed by the Administrator of Veterans Affairs on
February 10, 1982, following an intensive and thoughtful search and selection process.
The±new Director of the Readjustment Counseling Service, psychiatrist, Arthur S. Blank,
Jr., M.D., too Vietnam veteran and has been psychiatric consultant to the program since
its earliest planning stages in 1979.

�19.
A^third leadership jnitjative ^was taken on Jun? |f, 198?, when a new position was created,
C^hief pf^CpMn^eling Services, andean «*per4t clinician Dr. Raymond M.

Scurfield from

the Brentwood VA Medical Center was hired for this position.
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Underscoring the significance

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Counseling Program Is ;|he establishment |n November 1981 of a high-level Agency wide
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stee/ing commijtee tp.monitpr the^program,

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Improving the management. and^prganlzatjpn. :of the Vet Center Program has been one of
our top priorities. In addition to augmenting our Central Office program management
group, we have taken steps to strengthen the offices of pur six Regional Coordinators
who oyers.ee.

Vet

Center

operations in tl)eir .respective regions.

During

the

developmental phase of the program, each of these important offices was staffed by a
Regional Coordinator and a single secretary. Each Regional Office now has an Assistant
Coordinator for Administrative Services, and we are further strengthening the Regional
Coordinators' staffs with the appointment of an Assistant Coordinator for Clinical
Services and an additionalI secretary.

From an organizational standpoint, the most important development of recent months
has been the publication of a new program circular, which clarifies lines of authority and
responsibility. It contains several key elements:

~a. The responsibilities of the Director and the Readjustment Counseling Service
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Staff In Central Office for overall supervision and management of the program are
. spelled out. The Director and his staff have direct operational control of the Vet
Center system through the Regional Coordinators and, within Central Office,
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report to the Deputy ACMD for Professional Services and to the Chief Medical
Director through the Associate Deputy Chief Medical Director.

�20.
b. The responsibilities of the Regional Coordinator's staff are also clarified. We
have established clear lines of authority and responsibility from Vet Centers to the

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Regional Coordinator's staff to the Readjustment Counseling Service in Central
Office. The Regional Coordinators are responsible for selection and all supervision
, of the Team Leaders, and the program director is responsible for selection and all
supervision of the Regional Coordinators. We have also spelled out the relationship
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between Vet Centers and their local VA Medical Center parent facilities. The
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circular directs that the parent VA medical center is responsible for providing the
Vet Center all required support services.

On professional matters, the medical

center's role with respect to the Vet Center operations is to be consultative and
collaborative only.
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As part of our reconstituting of the management and organization of the readjustment
counseling program, we have instituted financial and accounting procedures which track
all program funds and maintain their earmarked character at the local level.
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As you know, Mr. Chairman, we have also established a mechanism to contract with
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veterans who do not have access to one of our Vet Centers. We are using a decentralized
model with a contracting committee at each of 122 medical centers. The contracting
committee includes two members of a Vet Center staff in each instance.

As of August

31, over 300 contracts had been awarded. We are currently evaluating the quality and
effectivenss of this new mode of service delivery.
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That concludes my statement, Mr. Chairman. I will be pleased to answer any questions
you or members of the committee may have.

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                  <text>&lt;p style="margin-top: -1em; line-height: 1.2em;"&gt;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.&lt;/p&gt;&#13;
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                    <text>Item ID Number

°0589

Author

Davis, Miriam

Corporate Author

Tne Llbrar

y of Congress Congressional Research Servic

Report/Article TltlO Agent Orange: Veterans' Complaints and Studies of
Health Effects, Issue Brief Number IB83043

Journal/Book Title
Yeer
Month/Day
Color

March 3

n

Number of Images

19

DeSCrlptOU NOtOS

Alvin L. Young filed this item under the category
"Human Exposure to Phenoxy Herbicides and TCDD"

Tuesday, February 20, 2001

Page 589 of 680

��AGENT ORANGE:

VETERANS' COMPLAINTS AND STUDIES OF HEALTH EFFECTS
ISSUE BRIEF NUMBER IB83043

AUTHOR:
Miriam

Davis

Environmental Health Fellow
Michael Simpson
Science Policy Research

Division

THE LIBRARY OF CONGRESS
CONGRESSIONAL RESEARCH

SERVICE

MAJOR ISSUES SYSTEM

DATE ORIGINATED 03/03/83
DATE UPDATED 03/03/83

FOR ADDITIONAL INFORMATION CALL 287-5700
0304

�CRS- 1

IB83043

UPDATE-03/03/83
I

ISSUE DEFINITION
From 1962 to 1971 the United States Air Force
(USAF) sprayed various
herbicides (chemicals that kill plants) in South Vietnam. The purpose of the
spraying was to defoliate jungle growth and to destroy enemy crops. The most
extensively used of these herbicide mixtures was known as Agent Orange, which
is an equal mix of two common herbicides called 2,4,5-T and
2,4-D
(2,4,5-trichlorophenoxyacetic acid and 2,4-dichlorophenoxyacetic acid).
A
contaminating chemical present in the mixture in small amounts was TCDD
(2 , 3 , 7 , 8-tetrachlorodibenzo-para-dioxin) , or simply "dioxin." Dioxin is a
contaminant produ-ced in the manufacture of 2,4,5-T.
Its toxic effects to
some laboratory animals are well known, yet its effects on humans are not
fully understood.
Since 1977, veterans have attributed a number of illnesses to Agent Orange
exposure, including skin conditions, cancer, fatigue, nervousness, numbness
in the extremities, vision and hearing impairments, birth defects in
children, and other
ailments.
Veterans
have
urged
the
Veterans
Administration (VA) to provide for medical treatment of these disorders and
many have filed for disability compensation.
Under P.L. 97-72, the Veterans' Health Care, Training, and Small Business
Loan Act of 1981, Congress directed the VA to furnish medical care to Vietnam
veterans, irrespective of age and financial status, for any condition which
might possibly have resulted from exposure to Agent Orange.
However,
disability compensation for the veterans' illnesses has been denied unless it
can be shown that the disabling condition began during the period of service.
This criterion of "service connection" effectively denies claims
for any
latent disorder arising from military service. Until a rigorous scientific
link between Agent Orange exposure and the health problems of the veterans
can be established, the Veterans Administration will probably continue to
deny the majority of veterans' requests for disability compensation.
The VA and other Federal agencies are sponsoring a variety of research
efforts to investigate the connection between Agent Orange and veterans'
health problems. Recent congressional interest has focused on the transfer
of responsibility from the VA to the Centers for Disease Control
for the
legislatively mandated epidemiology study of Vietnam veterans'
health
problems.
The following questions continue to surround the debate
effects of exposure to Agent Orange:

over

-- What are the adverse health effects of Agent Orange,
and what studies are being conducted to answer this
question?
-- How much and what kind of scientific evidence is
required to prove the right to disability compensation
for _the veterans?
-- On whom does the burden of proof lie to establish the
link between Agent Orange exposure and adverse health
effects?

the

health

�CRS- 2
—

IB83043

UPDATE-03/03/83'

What constitutes fair treatment of the veteran until
the scientific studies are concluded?

BACKGROUND AND POLICY ANALYSIS
History
The USAF operated its herbicide spraying program in South Vietnam until
the late 1960s when the National Cancer
Institute released animal
studies
which showed that the herbicide 2,4,5-T caused birth defects in mice. At the
same time, newspapers in Vietnam began to report health problems, including
birth defects, in rural populations which had been exposed to herbicides.
As the USAF was winding down its herbicide spraying program, it was also
recognized that the military supplies of 2,4,5,-T contained amounts of dioxin
suspected of being hazardous. The dioxin, which occurs as'a contaminant in
the manufacture of 2,4,5-T, has been found to be highly toxic to animals. In
fact, the birth defects previously attributed to 2,4,5-T exposure are now
thought possibly to be related to the contaminating dioxins. The average
levels of dioxin in the military Agent Orange were about 2 ppm.
There were
even greater concentrations of dioxin in other military herbicides less
frequently used in South Vietnam: approximately 32.8 ppm in Agent Purple, and
65.6 ppm in Agents Pink and Green.
In October 1969, the Air Force first restricted the use of Agent Orange to
areas remote from populations; then it stopped all airplane spraying of Agent
Orange in early 1970'and all helicopter spraying of Agent Orange by
1971.
All remaining Agent Orange stocks were gathered and stored at naval
facilities in either Gulfport, Mississippi, or Johnston Island in the Pacific
until they were incinerated at sea in 1977 during the PACER HO project.
The total amount of herbicides sprayed in South Vietnam from January
1962
to February 1971 was about 107 million pounds, according to a USAF report.
Approximately 276,000 gallons of Agents Green, Pink, and Purple were sprayed
in South Vietnam prior to 1965 when they were replaced by Agent Orange.
Approximately 11 million gallons of Agent Orange were then sprayed in South
Vietnam -- making it the most widely used herbicide of the war.
Ninety
percent of Agent Orange was sprayed on 2.9 million acres of inland
forests
and mangrove forests for defoliation, 8% was sprayed on enemy crops for crop
destruction, and the remaining 2% was sprayed around base perimeters, cache
sites, waterways, and communication lines.
The Department of Defense initially maintained that only a limited number
of U.S. military personnel could be positively identified as having been
exposed to Agent Orange i'n South Vietnam (i.e., the crews of aircraft that
were used to spray herbicides). However, following the publication of a 1979
General Accounting Office (GAO) report documenting ground troop exposure, the
DoD has acknowledged that greater numbers of ground troops were exposed to
Agent Orange through the USAF spraying program. Most recently, the DoD has
attempted to arrive at an exposure index for individual ground troops.
The American Medical Association has reported that about -2.4 million
Vietnam veterans may have been exposed to herbicides. This figure includes
ground troops, 1,200 flight crewmen who were responsible for the spraying
under Operation RANCH HAND, and 200 U.S civilians who were involved in
destroying the excess quantities of Agent Orange at sea. Details about U.S.
personnel exposures are presented in the following section.

�CRS- 3

IB83043

UPDATE-03/03/83

V

Following reports of various health problems in some 'Vietnam ^veterans
widespread concern about the possible health effects of Agent Orange was
expressed. Many veterans have filed claims for disability compensation with
the VA, basing their claims on Agent Orange effects. In 1979,
a group of
veterans initiated a class action suit against herbicide manufacturers for
negligence and product liability.
The manufacturers include Dow Chemical,
Monsanto, Hercules, Diamond Shamrock, and Thompson-Hayward. This litigation
is still in progress depending, in part, on the outcome of federally
sponsored studies of the health effects of Agent
Orange.
Chemical
manufacturers filed a third-party suit in 1980 against the U.S.
Government
that was later dismissed by a New York Federal District Court.
Personnel Exposed to Herbicides. The early trials that were conducted in
South Vietnam to improve aircraft spray systems were performed by the USAF
Special Aerial Spray Flight Division at Langley Air Force Base, Virginia.
During late 1962 and early 1963, the Crops Division at Fort" Detrick and the
USAF Armament Laboratory at Eglin Air Force Base, Florida, were also involved
in efforts to improve spray system components in support of Operation RANCH
HAND.
Most of the personnel involved in the actual handling of herbicide drums
were Vietnamese.
However, a USAF flight mechanic or crew chief was
responsible for ensuring that each aircraft was properly loaded and that the
spray systems were functional.
Each herbicide aircrew consisted of a pilot
and copilot, a flight mechanic, and a spray unit.
The aircrews were
frequently joined by South Vietnamese and U.S. observers.
As noted in a USAF
report: "within the aircraft, it was not uncommon to have herbicide leakage
from around the numerous hose connections joining the spray tank and pumps
with the wing and aft spray booms.
In hot weather, the odor of herbicide
within the aircraft was decidedly noticeable" (Young et ai., 1978: 1-18). It
.is also suspected that, due to destruction of the tanks by enemy fire, crew
members were acutely exposed to herbicides.
In an effort to determine which ground units were'exposed to Agent Orange
after it had been deposited on the ground, the Army Agent Orange Task Force
and the American Cancer Society are attempting independently to correlate
ground unit location with the location of aerial spraying missions. The USAF
has data on 6,542 herbicide spraying missions that took place between August
1965 and February 1971 on its HERBS computer tape. These data were compiled
on a mission-by-mission basis from reports and files in various offices in
the U.S. and South Vietnam. After evaluating
the HERBS data in a
1974
report, the National Academy of Sciences
(NAS)
concluded
that the data
accounted for approximately 86% of all herbicide operations in South Vietnam,
and that "despite certain recognized deficiencies," the HERBS tape is "areliable source for an assessment of the major part of the herbicide
operation in South Vietnam" and "is the best and in fact the only
available
comprehensive computation of the major
part of the herbicide operations
conducted in the Vietnam war."
Since this NAS evaluation,
the Army Agent
Orange Task Force has been in the process of expanding the scope of the HERBS
data to incorporate other herbicide sprays -- including perimeter base
spraying and any unplanned dumping of herbicides from U.S.
aircraft' that
were under enemy attack.
Despite this relative confidence in the location of the aerial and some
ground spraying missions, it is difficult to determine
which particular
ground troops in. a given location were actually exposed and to what extent
they were exposed.
Although aerial
spraying apparatus
was' designed to

�CRS- 4

IB83043

UPDATE-03/03/83

deliver the herbicide in a specified manner to reduce dispersion, no such
standardized equipment was used for perimeter base spraying or other
non-aerial delivery modes. Furthermore, additional
troops may have been
exposed in areas for which military records are incomplete. For example, not
all information is available on helicopter operations flown by the Vietnamese
Air Force before 1968.
Thus, attempts to model the conditions of exposure in
order to determine individual or group exposure levels are jeopardized by the
lack of verifiable exposure information.
When the DoD suspended all use of Agent Orange in South Vietnam, the USAF
was 'left with an inventory of 2.22
million gallons in two locations, in
Vietnam and in Gulfport, Mississippi.
In April 1972,
the stocks in South
Vietnam were transported to Johnston Island in the Pacific
for
storage.
Problems began to arise in both U.S and Pacific locations concerning
leakage
from the drums. After exploring a number of options, the USAF decided to
dispose of the Agent Orange by burning it at high temperatures at sea.
This
operation was performed in 1977 with permission from the EP'A. About 110 USAF
personnel from the Air Force Logistics
command and about 100 civilian
employees hired by a contractor were involved in the destruction process.
Environmental monitoring of the transfer operations was performed by members
of the USAF Occupational and Environmental Health Laboratory.
Extensive
environmental monitoring of the test incineration procedures was performed.
Certain physical parameters of the actual incineration
process
were
monitored.
Physical' examinations
of personnel involved in the actual
incineration procedures, administered both before and after these procedures,
revealed no adverse health effects.
Health Effects of Dioxin and Phenoxyherbicides
There are as yet no conclusive scientific studies on the long-term human
health effects of Agent Orange exposure. In their absence, an understanding
of health effects must rely on animal and/or human occupational
exposure
studies of dioxin and phenoxyherbicides. The following paragraph
summarizes
what is known about the health effects of these constituents of Agent Orange.
Workers exposed to high concentrations of dioxin and/or 2,4,5-T
(as well
as other chemicals) are commonly found to have a painful skin condition known
as chloracne. Chloracne can appear weeks to months after initial exposure
and in some cases persists up to many years after exposure.
Chloracne,
however, can result from exposure to other chlorinated
compounds besides
2,4,5-T. Studies of exposed workers have indicated a variety of other health
problems; yet, there is not enough information at this time to establish a
cause and effect relationship between phenoxyherbicides and these disorders.
Soft-tissue sarcoma, a form of 'cance.r/ has been reported among Swedish
workers who were exposed to phenoxyherbicides. Reports from a variety of
sources associate
dioxin and herbicide exposure with stomach
cancer,
neuromuscular weakness, liver enlargement, and liver enzyme abnormalities.
Birth defects were first reported in South Vietnamese refugees living in
North Vietnam, but, due to the difficulty of conducting studies in a war-torn
country, the research on these reports was widely believed to be improperly
executed. In animal studies, only certain strains of pregnant mice exposed
to dioxin show fetotoxicity and birth defects in offspring.
Exposed male
mice do not have deformed offspring.
Current Use. The EPA has registered 2,4-D for widespread domestic use on
such crops as corn, grain, and sugar cane, as well as on non-crop areas;
2,4,5-T
is currently used on rangelands, rice fields, and industrial
vegetation sites, whereas approval for its other domestic uses -- forests,

�CRS- 5

IB83043

UPDATE-03/03/83

rights-of-way, pastures' -- was suspended by the EPA in 1978.
registered use of '2,4,5-T depends on negotiations that began in 1979
Dow Chemical and the EPA.

Future
between

Herbicides 2,4,5-T and 2,4-D are commercially available either alone or in
combination.
The combination mixture (under Dow's Trademark, Esteron)
differs from Agent Orange primarily in the level of dioxin.
Existing Dow
inventories of 2,4,5-T contain less than 0.1 parts per million (ppm) dioxin,
whereas previous formulations of 2,4,5-T used in Agent Orange contained about
2 ppm dioxin. Although standards for dioxin levels in 2,4,5-T have not been
officially set by the EPA, the EPA's Science Advisory Committee recommended
in 1971 a level of 0.1 ppm.
Veterans' Complaints and Veterans Administration Efforts
Veterans who believe they have been exposed to Agent Orange have
complained of a variety of illnesses for which they seek 'medical treatment
and disability compensation.
These illnesses include:
skin conditions,
cancers, nervousness, numbness in extremities, vision
and/or
hearing
impairments, birth defects in their offspring, and reduced libido.
Veterans
have also complained about the paucity of scientific information available on
the health effects of Agent Orange and about the sluggishness with which the
VA has responded to their concerns.
Specifically, the General Accounting
Office (GAO) has recently reported that over half of the veterans responding
to their questionnaire were dissatisfied with the amount of information they
had received from the VA about Agent Orange.
To fill the perceived
information gap, various State 'governments, including New York and New
Jersey, have attempted to disseminate information on Agent Orange to State
veterans.
&lt;

The VA maintains that it
outset by initiating health
exposed and by implementing
description of the research

has responded
to veterans' concerns from the
programs to identify veterans who may have been
research projects on health effects. A detailed
projects is provided later in this brief.

Since 1978 the VA has provided a physical examination for Vietnam veterans
who thought they were exposed to Agent Orange. The VA maintains a registry
of all the veterans who have come to VA hospitals and health care facilities
for the exam. The registry also contains information collected
during the
examination.
As of Dec. 1, 1982, 101,721 veterans had received the initial
exam, and about 80% of the records had been coded into the computer.
The
idea behind the registry is to determine whether veterans have a higher
incidence of particular diseases.
GAO auditors have investigated
the effectiveness of the v Agent Orange
examination program. The findings are summarized in an October 1982
report,
"The V A ' s Agent Orange Examination
Program: Actions Needed
To
More
Effectively Address Veterans' Health Concerns." The report is 'critical of the
exam for being incomplete, poorly designed, and for being administered by
physicians who were not familiar with the reported health effects of Agent
Orange. In an appendix to the report, the VA challenges these findings by
citing improvements that 'have taken place since the evaluation; however, the
GAO disagrees with the VA rebuttal in the same appendix. The GAO report is
also critical of the registry because it cannot
be used to determine the
incidence of specific illnesses among veterans -- a major purpose for which
the registry was supposedly designed.
Medical Treatment: P.L. 97-72.

Before the enactment

of

P.L.

97-72

in

�CRS- 6

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UPDATE-03/03./83

1981, 'veterans who complained of Agent Orange-related illnesses were in a
ranking of the lowest priority for medical treatment at VA hospitals.
This
is because these illnesses were defined as not being "service-connected." To
have qualified at all for this treatment at this low-priority level, the
veteran had to be destitute. The "Veterans' Health Care, Training, and Small
Business Loan Act of 1981" (P.L. 97-72) elevated Vietnam veterans' priority
status for treatment at VA hospitals for any Agent Orange-related problem.
Veterans who complain of such problems are now considered for treatment
irrespective of age or finances with the same priority
status as former
prisoners of war and ahead of veterans with "non-service
connected"
conditions.
The Vietnam veterans' contention of exposure is acceptable in
the absence of evidence to the contrary. It is the duty of a '"responsible
staff physician (to) make a determination as to whether the condition
resulted from a cause other than the specified exposure." To aid the staff
physician, the VA has developed guidelines which identify conditions that are
not considered to be related to Agent Orange exposure (Federal Register, Nov.
17, 1982).
The VA contends that P.L.
97-72
is
being
implemented
successfully, yet veterans' advocates and State Agent Orange commissions
allege that veterans are uninformed about the new legislation and that
treatment is still difficult to obtain at certain VA medical centers. The VA
has initiated a new system to monitor the impact of P.L.
97-72 on Vietnam
veterans' medical treatment.
P.L. 97-72 also extended the readjustment counseling program for Vietnam
veterans for another three years.
The counseling programs are currently
located in "Vet Centers," which are distinct from VA medical facilities.
Disability Compensation. As of Jan. 3, 1983, veterans had filed 16,102
disability claims with the VA for disorders they attribute to Agent Orange
exposure. The vast majority of these claims have been denied because they
are not considered as being "service connected." The policy of the VA is
that a disability is considered "service-connected" if it arises during or is
aggravated by military service.
"Service-connection"
establishes temporal
correspondence with military service, not causation, as the determinant for
disability payments. Chronic conditions arising before discharge or within
one year after discharge are presumed to be "service-connected."
The policy implies that for a veteran to receive disability payments for
ailments possibly related to Agent Orange exposure, it must be proved that
the condition first appeared during the service or within a year of
discharge.
This precludes disability
for
latent
disorders
because
"service-connection" criteria cannot be met.
The VA acknowledges that the skin disorder, chloracne, is causally related
to Agent Orange exposure. On Apr. 15, 1980, in a statement before the House
Veterans.1 Affairs Subcommittee on Medical Facilities and Benefits, former VA
administrator Max Cleland said that "the relationship between
accidental
human exposure to Agent Orange constituents and the development of long-term
illnesses other than chloracne remains speculative at present." Even though
the VA does view chloracne as an immediate effect
(acute effect) of Agent
Orange exposure, the basis for awarding disability stems from the occurrence
of chloracne during the service. Temporal coincidence with active duty is
the major criterion, irrespective of cause, for chloracne or any other
veteran complaint.
The total of 1237 (15.3%) claims which were granted were awarded primarily
for skin conditions (94%)
and for cancer, psychiatric, and neurological
conditions (6%), among others.

�CRS- 7

IB83043

UPDATE-03/03/83

The VA denied 6,824 claims after there was a confirmed diagnosis of the
disease for which the veteran had filed a claim. The denied claims fall into
the following categories: 4091
for various skin conditions; 2432 for
nervousness and headache, or fatigue; 907 for paralysis or numbness; 791 for
gastrointestinal or genito-urinary conditions; 487 for malignancies which
include leukemia, lymphoma, melanoma, and Hodgkin's disease; 359 for impaired
sexual activity; 463 for eye, ear, nose, a-nd throat pathology; 289 for lung
conditions; 247 for cardiovascular conditions, and 146 claims denied for
miscellaneous conditions.
(Since each claim could fall into a variety of
different categories, the category figures do not equal 6,824.)
The VA policy is that the resolution of disability claims
for conditions
that are now defined as "non-service connected" (and therefore denied) will
depend on the results of scientific studies which are described below. Since
it is expected that these studies will take years to complete, the Chief
Medical Director of the VA, Dr. Donald Custis, has testified at a hearing of
the House Veterans Affairs Subcommittee on Investigations and Oversight on
Sept. 15, 1982, that "It may well be that the Congress cannot wait for
scientific answers in the short term, in which case it may well be that the
sociopolitical aspect of this problem will have to be addressed."
Current...._or. Proposed Studies of ^Health Effects
Many branches of the Federal Government are conducting research on the
health effects of Agent Orange and phenoxyherbicides. Research efforts range
from large-scale epidemiology studies of Vietnam veterans to studies of
cancer among Kansas
residents exposed to herbicides.
The
following
paragraphs provide an overview of research efforts at the Department of
Defense, the Veterans Administration, and the Department of Health and Human
Services.
The impact of the following studies on VA disability policy is not
clear; the VA has not established any formal criteria for how their
policies
might be altered by scientific findings.
Due to the recent transfer of the legislatively mandated
epidemiology
study of Vietnam veterans and to the interest which this study has generated
all along, it will be discussed first.
E p i de m i o 1 o g y Study. The large epidemiology study of Vietnam veterans
exposed to Agent Orange, mandated by P.L. 96-151 in December 1981,
has been
the focus of much of the debate over the health effects of Agent Orange.
P.L. 96-151 directed the VA to perform the study of long-term health
effects
among veterans using' a protocol that was subject to approval by the
congressional Office of Technology Assessment (OTA); in addition, the OTA
director was given the task of monitoring the progress of the study.
The
protocol was reviewed by the OTA, the VA advisory group on the health-related
effects of herbicides, the science panel of the Agent Orange Working Group,
and the National
Academy of Sciences.
P.L.
97-72 allowed for future
expansion of the scope of the study.
The implementation of the study was delayed until October 1982,
at which
time the responsibility for conducting the study was transferred from the VA
to the Centers for Disease Control
(CDC).
The transfer was accomplished
following letters to the VA from the Veterans Affairs Committees of the House
and the Senate. The letters expressed concern over the lack of progress on
the study and concern over the VA's credibility
with the
veterans;
consequently, the VA was urged to relinquish the. study to an independent
research body. While the VA acceded to this request, former VA Administrator

�CRS- 8
Nimmo'attributed the delay of the
protocol review process.

study

IB83043
to

legal

UPDATE-03/03/83

challenges

and

to

the

On Jan. 18, 1983, the CDC formally accepted responsibility for the study
in a written agreement with the VA.
Under the agreement, the VA is to
provide the CDC with $3 million to fund the study, yet the CDC is assured of
autonomy in its design and implementation. The project will actually consist
of two studies, one on the health effects of Agent Orange and the other on
the health effects of the Vietnam experience. The study' designs are expected
to be ready for OTA review in April 1983.
Preliminary reports suggest that
the veterans under study will be divided into three groups (cohorts)
—
one
group made up of those who were likely to have been exposed to Agent Orange,
another group constituting those who were unlikely to have been exposed, and
a final group of veterans who did not serve in Vietnam and who were not
likely to have been exposed. The DoD'is assisting the CDC in establishing
criteria for assigning an individual veteran to a particular
group.
The
selection process will depend on the use of DoD records ' of ground troop
movements relative to herbicide spraying.
Completion of the study is
expected by the end of 1987.
Department of Defense. The Air Force is conducting "The Ranch Hand
Study," an epidemiological study of personnel exposed to herbicides during
the Air Force's aerial spraying program in Vietnam (Operation Ranch Hand).
These personnel were members of flight crews involved in the handling and/or
spraying of herbicides, and they were presumed to have been heavily exposed.
This study population of 1,260 personnel is being compared to a control
population consisting of unexposed flight crew members.
The purpose of the study is to determine whether Ranch Hand flight crews
suffered adverse health effects compared to the control
population.
The
study consists of three parts: a mortality study; a morbidity (disease) study
which includes birth defects in offspring; and a follow-up period of physical
examinations at specific intervals (up to 20 years) from the onset of the
study. Information for the morbidity and follow-up portions is collected by
questionnaires administered in the homes of the participants and by extensive
physical and psychological tests.
These data are collected
by
the
independent contractors Louis Harris and Associates and Kelsey-Seybold
Clinic, respectively. Before data collection began in 1980, the entire study
protocol had been reviewed by the University of Texas
School of Public
Health, the U.S Air Force 'Science Advisory Board, the Armed
Forces
Epidemiological Board and the National Academy of Sciences.
The initial phases of mortality and morbidity data collection
were
completed in December 1982.
For the morbidity study, participation
in the
questionnaire and physical examination has been very high (greater than
95%)
and an interim report is expected by the summer of 1983.
The findings of the
mortality study (due to be released early in 1983) suggest that there are no
differences in the number of deaths between the Ranch Handers and controls.
Periodic reassessment of the mortality findings are planned throughout the
20-year study by the Air Force School of Aerospace Medicine.
While the Ranch Hand Study is expected to provide some
valuable
information about the population of herbicide sprayers, the applicability of
the Ranch Hand Study to the experience of ground troops has been questioned.
For example, the herbicide exposure conditions are thought to differ between
the two groups. The Ranch Handers were heavily exposed at sporadic intervals
(repeated acute exposures) and the exposure was through the skin, through
inhalation, and through ingestion. After the missions, the flight crews were

�CRS- 9

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UPDATE-03/03/83

required to shower. While the extent and mode of ground troop exposure are
less certain, it is likely that the mode of ground troop exposure was
primarily due to skin contact and to inhalation.
The duration of ground
troop exposure was likely to be for longer periods due to operational
movements through contaminated areas. Thus, because the exposure conditions
of Ranch Hand personnel did not mimic those of ground troops, the general
relevance of the Ranch Hand study is not certain.
One of the criticisms
raised by the National Academy of Sciences in their May 1980
review of the
Ranch Hand protocol was that adverse health effects were not likely to be
found because the sample size was too small and the follow-up period was too
short. In response, the Air Force did extend the follow-up period to 20
years; nevertheless, the problem of sample size makes it unlikely that the
study will detect certain cancers that are relatively rare.
The impact of
Agent Orange exposure on the incidence of these rare cancers
(e.g.,
soft-tissue sarcoma and non-Hodgkin's lymphoma), may be most appropriately
determined by the case control sutdies in New York State and at.the National
Cancer Institute.
V e t e r ans Adm i n i s t rat ion. The Veterans Administration intends to spend
$6.7 million of the total 1983 medical research budget of $163 million for
projects on the health effects of herbicide exposure and, more generally, the
health effects of combat duty in Vietnam. The majority of these research
dollars ($4.2 million) is destined for the epidemiology study of Vietnam
veterans, a mortality study, and an identical twin sibling study.
Due to
congressional pressure, responsibility for the conduct of the epidemiology
study has been transferred
from the VA to the CDC.
Funding for the
epidemiology study, however, will continue to be provided by the VA.
Both the mortality and the twin study address the impact of the Vietnam
experience rather than Agent Orange in particular.
The purpose of the
mortality study is to examine
the cause-of-death
and the death rate in
Vietnam veterans by comparison to veterans who did not serve in Vietnam. The
idea is to determine whether military service in Vietnam has resulted in
different death profiles since the end 'of the war.
Computer records will
provide the information, and this information will be collected and coded by
contractors for the VA. The project is expected to be finished by 1985.
The Identical Twin Study, -also sponsored by the VA, is designed to
determine whether the current psychological and physical health of Vietnam
veterans has been adversely affected by their service.
In this study, a
group of VA researchers in St. Louis is attempting to study 450 pairs of
identical twins; one twin served in Vietnam during the period of herbicide
exposure, whereas the other twin was not stationed in Southeast Asia.
Initial findings of this study are expected by October 1984.
The VA has also established the Chloracne r Task Force to identify veterans
with skin conditions and then to see if . there are bona fide cases of
Chloracne within this group. Thus far, a dermatologist who is serving as a
consultant at the Washington VA office has found 12 tentative cases of
Chloracne which require further investigation.
Another VA research activity is a study of dioxin in the fat tissues of
veterans. In conjunction with the EPA, the VA intends to find out whether
Vietnam veterans have higher levels of dioxin in their fatty tissues than
non-Vietnam veterans.
Background levels of dioxin in the U.S.
male
population are also to be analyzed. To detect dioxin concentrations in the
fat, tissue is removed surgically from the abdomen and the sample .is analyzed
on gas chromatography/high resolution mass spectrometry instruments.

�CRS-10

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l

Department of Health and_
Human
Services:
Centers
for
Disease
C o n tr o1/B irth Def e_c t Stu dy. An ambitious epidemiology study is underway in
Atlanta to find out if Vietnam veterans show an increased risk of having
children with birth defects. Using the case-control method, CDC researchers
are interviewing 7000 parents of children with birth-defects and 3000 parents
whose children are normal. The interview process is used to establish the
military history of the parents.
This information will be analyzed
to
determine wheth'er parents who served in Vietnam are at greater risk of
producing children with birth defects. Already one-half
of the interviews
has taken place, with initial findings expected by September 1983.
Sponsors
of the study are DHHS, VA, and DoD.
DHHS:
National Cancer^ I n s t i t u t e / Can c e r Study.
Epidemiologists
are
investigating a Kansas population for the relationship between herbicide
exposure and various cancers. The research question is: do such cancers as
soft tissue sarcoma and various lymphomas result from herbicide exposure?
Kansas residents are considered a good population for studying herbicide
exposure because in this wheat-growing State herbicides are used much more
often than insecticides. In other States, herbicides are frequently used in
combination with insecticides, which are also implicated in producing cancer.
Insecticide exposure would confound the results of such a cancer
study.
Preliminary results of this study are anticipated by the'fall of 1983.
DHHS; National Institute of^Occupational Safety and Health/Dioxin
Worker
Registry.
NIOSH is compiling a ' registry of workers involved in the
manufacture "of 2,4,5-T and related compounds because these compounds
contain
dioxin as a contaminant. Worker exposure records on 3000-5000 individuals,
compiled from all 12 U.S. sites of production, will go back
to the 1940s.
T'he purpose of the registry is to establish whether the mortality
rates
are
higher in this,population of exposed workers than in a comparable
group in
the U.S.population.
The protocol
has been reviewed by an independent
university-affiliated group of scientists, and the analysis of the findings
is due by 1985.
Role of State Commissions or Advisory Groups
Several States have established their own agencies in response to
veterans' complaints of Federal inactivity
on the Agent Orange
question.
Although these organizations
vary in structure, their
functions
are
essentially similar:
to identify State Vietnam veterans and to provide and
coordinate various social services for these veterans. For example, various
State commissions disseminate information on Agent Orange and assist in
scheduling Agent Orange examinations at VA medical centers.
Those States
which have commissions or programs on Agent Orange are as
follows:
California, Connecticut,
Georgia,
Hawaii,
Illinois,
Kansas,
Maine,
Massachusetts, Minnesota, New Jersey, New York, Oklahoma, Ohio, Pennsylvania,
Texas and West Virginia.
(Wisconsin's program has been discontinued.)
Some .of these States are funding their own research programs aimed at
answering questions on the health effects of Agent Orange. In the "spring of
1983, New York is due to release findings of a study on the incidence of
soft-tissue sarcoma among State veterans relative to other State inhabitants.
Soft-tissue sarcoma has been implicated as a possible long-term health effect
of herbicide exposure. New York State has also undertaken a mortality study
to see if death rates are higher among Vietnam veterans than other State
residents of the same age group.

�'

I

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UPDATE-03/03/83

The New Jersey State Commission on Agent Orange has a variety of pro-jects
underway. One task has been to assemble information on a bacterial infection
called Melioidosis, which may have afflicted veterans who were exposed to the
bacterium while in Vietnam.
The Commission is beginning a project to
determine whether blood tests can be reliably used to measure dioxin levels.
Blood tests would obviate the need for more expensive and painful surgical
procedures now performed for this purpose.
In addition, the New Jersey
Commission on Agent Orange distributes pamphlets on how to fill out VA
disability claims forms.
The role of the State commissions is growing to include advocacy for State
veterans. State representatives have testified at congressional hearings and
at the VA advisory committee meetings to bring attention to veterans'
complaints. At the Nov. 30, 1982, meeting of the VA advisory committee on
the health-related effects of herbicides, the spokesperson for State agencies
endorsed legislation
that
would
establish
the
presumption
of
a
"service-connection" for chloracne and soft tissue sarcoma "so that veterans'
disability claims for these disorders would be awarded.
Because of the lack of State funds, some of the State commissions are no
longer active and others are i.n jeopardy. State commissions have requested
Federal funds on the grounds that they assist in the administration of VA
programs such as the scheduling of Agent Orange examinations and informing
State veterans about Agent Orange exposure.
Previous Congressional Ac^tipn
As previously discussed, two major pieces of legislation have been enacted
in the 96th and 97th Congresses- to provide for Vietnam veterans' medical care
and to mandate studies of the health effects of Agent Orange:
P.L. 96-151,
The Veterans' Health Programs Extension and Improvement Act of 1979; and P.L.
97-72, Veterans' Health Care, Training and Small Business Loan Act of 1981.
The 'legislative proposals of the 96th and 97th Congresses were generally
directed to the status of disability claims that are now denied by the VA
because they are not considered as "service-connected." In Representative
Daschle's proposed 97th Congress bills, H.R.
7146
and H.R. 7110,
the
presumption of service connection would have been legislatively established N
for soft-tissue sarcoma and chloracne, respectively.
The presumption of
service connection would have permitted veterans with these disorders to
collect disability payments because the conditions were presumed to have
arisen during the service. Two other 97th Congress
bills, H.R. 523
(Rep.
Roe) and H.R. 2297 (Rep. Downey), were designed to provide a presumption of
service connection for all chronic conditions specifically related to Agent
Orange exposure which appear later than one year, after discharge.
Existing
law requires that disabling conditions only appearing before discharge or
within one year after discharge are presumed to have arisen during the
service. Finally, a number of bills were introduced to transfer the conduct
of the epidemiology study from the VA to the Department of Health and Human
Services. This was accomplished -- although non-legislatively -- with the
transfer of responsibility to the Centers for Disease Control in the DHHS.
LEGISLATION
H.R. 209 (Long)
Requires the Secretary of Health and Human

Services

to

arrange

for

an

�CRS-12

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UPDATE-03/03/83

independent epidemiological study of persons exposed to the chemical dioxin,
used in the h.erbicide known as Agent Orange.
Introduced Jan.
3,
1983;
referred to Committee on Energy and Commerce.
H.R. 212 (Long)
Amends Title 38, United States Code, to waive the one-year limitation on
claims for compensation "frojn the Veterans Administration for disabilities and
diseases incurred in or aggravated by military service in the case of claims
by veterans who served in Southeast Asia during the Vietnam era for
compensation for disabilities resulting from exposure to the phenoxyherbicide
known as Agent Orange or other phenoxy herbicides.
Introduced Jan.3,
1983;
referred to Committee on Veterans Affairs.

H.R. 331

(Roe)

Amends Title 38, United States Code, to waive the one-year
limitation on
claims for compensation from the Veterans Administration for disabilities and
diseases incurred in or aggravated by military service in the case of claims
by veterans who served in Southeast Asia during the Vietnam era for
compensation for disabilities resulting from exposure to the
phenoxy
herbicide known as "Agent Orange" or other phenoxy herbicides. Introduced
Jan. 3, 1983; referred to Committee of Veterans Affairs.
H.R. 462

(Applegate)

Amends Title 38, United States Code, to waive the one-year
limitation on
claims for compensation from the Veterans Administration for disabilities and
diseases incurred in or aggravated by military service in the case of claims
by veterans who served in Southeast Asia during the Vietnam era for
compensation for disabilities resulting from exposure to the phenoxyherbicide
known as Agent Orange, or other phenoxy herbicides.
Introduced Jan. 6, 1983;
referred to Committee on Veterans Affairs.
H.R. 509 (Hammerschmidt)
Amends Title 38 of the United States Code to provide that progressive
muscular atrophy or amyotrophic lateral sclerosis developing a 10 per centum
or more degree of disability within seven years after separation from active
service during a period of war shall be presumed to be service connected.
Introduced Jan. 6, 1983; referred to Committee on Veterans' Affairs.
H.R. 1135

(Downey)

Amends Title 38, United States Code, to waive the one-year
limitation on
claims for compensation from the Veterans Administration for disabilities and
diseases incurred in or aggravated by military service in the case of claims
by veterans who served in Southeast Asia during the Vietnam era for
compensation for disabilities
resulting from exposure to the
phenoxy
herbicide known as Agent Orange, or other phenoxy herbicides.
Introduced
Feb. 1, 1983; referred to Committee on Veterans Affairs.
H.R. 1382 (Downey)
Provides that any award by the Veterans' Administration of compensation
for a disease or disability in a veteran resulting from exposure
to Agent
Orange shall be retroactive to the date the veteran first applied to the
Veterans' Administration for compensation for such disease or disability.
I n t r o d u c e d _ F e b . 10, 1983; referred to Committee on Veterans' Affairs.

�CRS-13

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UPDATE-03/03/83

'*.

i

S. 374

(Specter)

A m e n d s Title 38, United States Code, to provide a presumption of service
connection for the occurrence of certain diseases in veterans who were
exposed to phenoxy herbicides while serving in the Armed Services in
Southeast Asia during the Vietnam era.
Introduced Feb. 2, 1983; referred to
Committee on Veterans Affairs.
HEARINGS
U.S.

Congress. House. Committee on Interstate and Foreign
Commerce. Subcommittee on Oversight and Investigations.
Agent Orange:
exposure of Vietnam veterans. Hearing,
96th Congress, 2d session.
Sept. 25, 1980.
249 p.
Involuntary exposure to Agent Orange and other toxic
spraying. Hearings, 96th Congress, 1st session. June 26
and 27, 1979.
256 p.

U.S.

Congress. House. Committee on veterans' Affairs. Ad
Hoc Subcommittee on Hospitals and Health Care. Legislation
to improve medical programs administered by the Veterans
Administration (H.R. 2157, H.R. 2953, and H.R. 2999).
Hearing, 97th Congress, 1st session.
Apr. 28, 1981.
54 p.

U.S.

Congress.
House. Committee on Veterans' Affairs.
Subcommittee on Medical Facilities and Benefits. Herbicide
"Agent Orange."
Hearing, 95th Congress, 2d session.
Oct. 11, 1978.
62 p.
Oversight hearing to receive testimony on Agent Orange.
Hearing, 96th Congress, 2d session.
Feb. 25, 1980.
121 p.

._

_, oversight hearing to receive testimony on Agent Orange.
Hearing, 96th Congress, 2d session. July 22, 1980.
459 p.
Scientific community report on Agent Orange. Hearing,
96th Congress, 2d session.
Sept. 16, 1980.
145 p.

U.S.

Congress. House. Committee on Veterans' Affairs.
Subcommittee on Oversight and Investigations. Current
status of Agent Orange studies. Hearing, 97th Congress,
1st session. May 6, 1981.
385 p.
Federal Agent Orange activities and the vet center program.
Hearing, 97th Congress, 2d session.
Sept. 15, 1982.
164 p.

U.S.

Congress. Senate. Committee on Veterans' Affairs. Agent
Orange update and appendix: Agent Orange activities (part
II) . Hearing, 96th Congress, 2d session.
Sept. 10, 1980.
1368 p.
Oversight on issues related to Agent Orange and other
herbicides. Hearing, 97th Congress, 1st session.
Nov. 18,
1981.
500 p.

�CRS-14

IB83043

UPDATE-03/03,/83

VA health resources and program extensions and appendix:
Agent Orange activities. Hearing, 96th Congress, 1st
session, on S. 741 and S. 196.
Apr. 10, 1979.
462 p.
Veterans' Programs Extension and Improvement Act of 1981.
Hearing, 97th 'Congress, 1st session, on S. 26 (titles II
and III, only), S. 380, S. 458, S. 636, S. 689, S. 872,
S. 914, S. 921, and related bills. Apr. 30, 1981.
685 p.
Vietnam veterans' readjustment. Hearings, 96th Congress,
2d session. - F e b . 21, Mar. 4, and May 21, 1980.
Part 2.
595-2082 p.

i
ADDITIONAL REFERENCE SOURCES
American Medical Association. Council on Scientific Affairs.
Health effects of "Agent Orange" and dioxin contaminants.
1981.
37 p.
Boffey, Philip. Agent Orange: Despite spate of studies, slim
hope for answers. New York Times, 1982.
24 p.
Cookson, Clive. "Emergency" ban on 2,4,5-T herbicide in U.S.
Nature, v. 278, Mar. 8, 1979:
108-110.
Galston, Arthur W. Herbicides:
V. 29, Feb. 1979:
85-90.

a mixed blessing.

Bioscience,

International Agency for Research on Cancer. IARC monographs
on the evaluation of the carcinogenic risk of chemicals
to man: 2,5,5-T, v. 15, Aug. 1977.
JRB Associates. Review of literature on herbicides, including
phenoxy herbicides and associated dioxins. Washington,
Veterans Administration, 1981.
2v.
National Research Council. The effects 1 of herbivcides in South
Vietnam: Part A. Summary and conclusions.
Washington,
National Academy of Sciences, 1974.
AD-774-749. 398 p.
National Research Council. The effects of exposure to Agent
Orange on ground troops in.Vietnam. Washington, National
Academy of Sciences, 1982.
24 p.
New Jersey State Commission on Agent Orange.
1982.
54 p.

Legislative Report.

Reggiani, G. Toxicology of TCDD: short review of its formation,
occurrence, toxicology and kinetics, discussing human health
effects, safety measures and disposal. Regulatory Toxicology
and Pharmacology, v. 1, 1981:
211-243.
Rosenblatt, Jean. Compensating victims of toxic substances.
Editorial Research Reports. v. 11, Oct. 1982:
759-772.
Tung, T.T., T.K. Anh, B.Q. Tuyen, D.X. Tra, and N.X. Hugen (1971).
Clinical effects of massive and continuous utilization of

�'V*
1

CRS-15

-*

».
U.S.

IB83043
.

defoliants on civilians.

.

.

.

Vietnamese Studies, 29:

.

UPDATE-03/03/83
.

53-81.

General Accounting Office. U.S. ground troops in South
Vietnam were in areas sprayed with herbicide orange. Nov.
16, 1979.
FPCD-80-23.
VA's Agent Orange examination program: auctions needed to
more effectively address veterans' health concerns. Oct. 25,
1981.
HRD-83-6.

Young, Alvin et al. The toxicology, environmental fate and human
risk of herbicide orange and its associated dioxin.
The
Surgeon General, U.S. Air Force, Washington, D.C.
Oct. 1978.

�APPENDIX
A LISTING OF
FEDERAL ORGANIZATIONS ON AGENT ORANGE
January, 1983
I. Cabinet Council on Human Resources
Agent Orange Working Group (AOWG)
Chairman: James Stockdale (HHS) Alternate: Bart Kull
Members: HHS, VA, DoD, Dept. Agriculture, Dept. Labor, EPA, ACTION
Agency, OMB, OSTP, Council of Economic Advisors, Dept. State
(OTA- Observer Status)
Activities: Moniter and coordinate Federal Research activities on
health effects of Agent Orange.
Science Panel: Dr. Vernon Houk (CDC)
II. Veterans Administration
Advisory Committee on Health Related Effects of Herbicides
Chairman: Dr. Barclay Shephard (VA)
Members: VA, Veterans Groups, FDA, CDC, EPA, Army Medical Corps,
Dept. Agriculture, NIH, private universiites
Activities: Advise Administrator of VA on health effects of Agent Orange
Agent Orange Projects Office
Acting Director: Dr. Barclay Shephard (VA)
Members: In-house administrative and research staff, Dept. of Medicine
and Surgery, VA
Activities: Coordinate and moniter epidemiology projects at VA on
Agent Orange and related research effortsAgent Orange Policy Coordinating Committee
Chairman: Everett Alvarez, Jr. (VA)
Members: In-house staff involved in medical information and medical
claims.
Activities: Review VA policy to make recommendations on Agent Orange
issues to the administrator of the VA.
III. Department of Defense
Army Agent Orange Task Force (AAOTF)
Chief: Richard Christian (Army)
Members: Army, Navy, Air Force, Marines, and civilian staff
Activities: Provide VA with information from military records
for the research projects on Agent Orange.

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A

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Washington Post

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1982

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July 5

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Number of Images

9ent Orange Study Still on Launch Pad

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1

Doscrlpton Notes

Monday, June 11, 2001

Page 1694 of 1793

�... A13

THE IteDERAL REPORT
Agent Orange Study Still on Launch Pad
By Pete Barley
n PmlSurt Writer

It has been three years since Congress ordered the Veterans Administration to investigate whether the
use of Agent Orange and other defoliants during the Vietnam war
harmed American GIs and entitled
them to special compensation.
The VA still hasn't launched that
study. It hasn't even decided what
scientific protocols or criteria the
study wi'J use.
VA critics, mostly Vietnam veterans, claim the agency is stalling
because of VA Administrator Robert
P. Nimmo's stated concern that the
study could result in costs to the
government of untold millions if it
were to show a direct link between
the military's use of toxic chemicals
and GI health problems.
Those daim* am -"p^HtflUIy motivated and absolutely false," said
Maurice LeVois, director of the VA's
Agent Orange program. "There hasnt
been any foot-dragging on our part,"
added Dr. Vemon N. Houk, chairman
of the government's main scientific
panel studying Agent Orange.
So far. more than 60,000 Vietnam
veterans have complained to the VA
of various ailments they blame on
Agent Orange, including skin rashes,
headaches, nausea and cancer. Some
also claim Agent Orange has caused
birth defects in their children.
While the VA hasn't officially
started the big study, the government is conducting 36 research- projects related to Agent Orange and is
considering at least 12 new projects,
official* said, including one that
would compare the health of identical twins, one of whom served in
Vietnam. Those projects are proof
the government is moving as quickly
at possible, officials said.
While such studies may be important the VA study remains the key
to determining whether the government owes special compensation to
Vietnam vets. That study, officials
admit, i» a long way off.
Congress ordered the study after
Vietnam veterans claimed the agency was indifferent to their problems,
3aid Ronald Simon, an attorney with
•J» National Veterans Law Center
who has been active in the Agent
Orange controversy.
Mistrust between Vietnam vets
Uld the VA was so great that Presdent Carter formed an umbrella
p-oup—the Interagency Working
jfoup to Study the Possible Longterm Health Effects of Phenoxy
Herbicides and Contaminants— tn

Some Data Expected Next Year
By the fall of 1983, the government will begin receiving preliminary
data from four major studies related to Agent Orange, according to
Dr. Vemon N. Houk, chairman of the government science panel that
is monitoring herbicide studies.
Here's a thumbnail sketch of each:
• The Ranch Hand Study is a 20-year project that involves monitoring the health of 1,264 Air Force personnel who flew on herbicide
spraying missions. Preliminary data will include physicals and questionnaires about the subjects' health.
• The Vietnam Mortality Study does not specifically have anything to do with Agent Orange, but scientists hope that they can learn
general information about Vietnam-era soldiers by comparing the
death rates and causes of death of soldiers who served in Vietnam
and those who served elsewhere during the same period.
• The Birth Defects Study involves comparing 7,500 babies born
with defects to 3,000 normal babies. Interviews will be done to see if
any of the children with defects had Vietnam veterans as parents and
whether those parent* came in contact with Agent Orange.
• The National Institute of Occupational Safety and Health is
developing a registry of workers who worked in Agent Orange manufacturing plants to see if they have experienced health problems similar to those reported by Vietnam veterans.
ROBERT P. NWMO '
. concerned about potential costii
oversee Agent Orange studies. The
group included officials from the VA
and the Defense and Health and
Human Services departments.
"It was created to ride herd on the
VA and bring it into the 20th Centalry," Simon said. Jodie Bernstein, the
group's first chairman, agrees Carter
formed it because of "very serious
complaints about the objectivity of
the VA." In retrospect, Bernstein laid,
the VA's problems were not caused by,
bias, but came about because the
agency was unprepared to perform
such a study. It did not have doctors
on its staff familiar with epidemic!ogical research, she said, nor did it
know how to direct such a study.
Neither, apparently, did anyone
else. In fact, Bernstein recalled, several government scientists claimed it
would be impassible to do an accurate epidemioiogfcal survey because
no one at the Pentagon seemed to
know for sure how many soldiers
had come into contact with Agent
Orange, and to what degree. '
Bernstein and other panel members told Congress that it needed to
expand its •original order by telling
the VA to study the general health
of all Vietnam veterans. "If their
health was worse [than that of people who didn't serve in Vietnam],
then we should address why it was
that way, and whether the government had a responsibility to do
something about that," she said.
While the panel debated whether

a study could be done, the VA began by the Agent Orange group. That
seeking a private firm to develop doesnt mean, however, that the
study protocols. When Simon's study will be underway soon.
group saw the VA's plan, it sought a
The UCLA protocol calls for comfederal court injunction to stop the paring two groups of Vietnam veterVA from issuing a contract The VA ans, one that was exposed to Agent
plan was "unclear... a pile of gar- Orange, and one that wasnt, LeVois
bage,' Simon said. The judge refused explained. That's what the VA origand the VA awarded a contract in inally wanted, but last year ConMay, 1981, for $114,288 to a re- gress—worried about the status of the
search team at the University of Cal- VA study-decided that the VA could
ifornia at Los Angeles.
expand its mandate if it wanted.
By this time, President Reagan
Some VA officials now want to
had taken office, reorganized the add a third group to the protocol—
working group and renamed it the GIs who were not in Vietnam but
Agent Orange Working Group. He who were in the military during the
gave it Cabinet-level status as a sign Vietnam era. That would help the
of his commitment to problems fac- VA determine whether just being in
Vietnam might have caused GIs
ing Vietnam vets.
Reagan's actions pleased the vet- health problems.
The working group will decide
erans, but within weeks they were
angry again. A key member of the this fall whether to add the third
group, LeVois said. If it does, much
UCLA team told the California legislature that the dangers posed by of the work done by the UCLA team
might have to be discarded and the
Agent Orange had been exaggerated
in the media. Nimmo, meanwhile, study would, again, face delays.
publicly compared the consequences
of Agent Orange to teen-age acne
and said Vietnam veto were demanding "preferential coddling." Vietnam
vets again charged bias.
In November, UCLA released its
first protocol report The Agent Orange Working Group said it could
not even be "classified as a protocol."
UCLA said the VA had given it
mixed signals about what it wanted.
In March. UCLA returned with a
revised protocol that was accepted

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°1498

Author

Gough, Michael

Corporate Author
Report/Article TltlO Typescript: Chapter 9: The Political Assessment: A
Congressional View

Journal/Book Title
000

Year

°

Month/Day
Color

n

Number of Images

10

DOSCrlptOH Notes

Tnis

Tuesday, May 15, 2001

manuscript is a draft version of a chapter or section
from the following book: Agent Orange and its
Associated Dioxin: Assessment of a Controversy.
Young, A. L. and G. M. Reggiani, eds. New York:
Elsevier, 1988. This book is available in the NAL
collection, call no.: RA1242 T44 A3.

Page 1498 of 1514

�CHAPTER 9
"THE IMPORTANCE OF AGENT ORANGE AND DIOXIN WAS
ACKNOWLEDGED WHEN THE HIGHEST LEVELS OF GOVERNMENT BECAME
INVOLVED,"
THE POLITICAL ASSESSMENT:

A CONGRESSIONAL VIEW

MICHAEL GOUGII

In December, 1979, Congress passed and President Carter
signed Public Law 96-151, which instructed the Veterans Administration to carry out a study of possible long-term health
effects resulting from exposure to dioxin-containing herbicides
in Vietnam.
This was not the first time that Congress had considered
Agent Orange. Almost a decade earlier, in 1970, Senator
Philip Hart; of Michigan held hearings about the possibility
that spraying with Agent Orange was causing birth defects in
Vietnam and that the use of the same herbicides could be harmful for the population of the United States. In response to
those hearings, the Department of Health reduced the use of
2,4,5-T in the United States and the Department of Defense
stopped Agent Orange spray missions in Vietnam.
The law that was passed in 1979 mandating the Agent Orange
study resulted from veterans testifying before Congress that
Agent Orange had caused cancer, birth defects, and other health
effects. It directed the Veterans Administration to study
ground troops who had served in Vietnam to see if any long-term
health effects in veterans or their families could be related
to the use of Agent Orange. To prod the Veterans Administration
along, Congress said that the protocol for the study had to be
designed within 180 days or the Congress had to be told the
reason why.

9: 1

�The OTA (Office of Technology Assessment), which is a
technical support office of. Congress, was directed by law to
review and approve the plans for the Veterans Administration
study and to monitor the conduct of the resulting study. The
bulk of my presentation is about OTA's role, but before going
into that, I will discuss other major events in the Agent Orange
issue.
Some results are now available from the Ranch Hand
study, the mortality and morbidity study of the Air Force
personnel who flew the spray missions in Vietnam, which was
well underway in 1979. The Air Force had responded early to
Congressional inquiries and realized that they had an occupational
health problem. They moved ahead on their own without the
intense prodding Congress put on the Veterans Administration
for the ground troop study. George Lathrop has dismissed
those studies.
Also in December, 1979, President Carter established the
Agent Orange Working Group (AOWG), composed of Executive
Branch agencies with programs that touched on possible effects
on health of dioxin, Agent Orange, and herbicides. In February,
1980, the Office of Technology Assessment was invited to sit
with the Agent Orange Working Group as an observer, and it
became an active participant in this group. In August, 1981,
President Reagan placed the Agent Orange Working Group into
the Cabinet Council on Human Resources, elevating and enlarging the scope of the work group.
The Agent Orange Working Group has had profound effects
on Executive Branch efforts to try to better understand dioxin
and Agent Orange. Among the several studies coordinated by
the Agent Orange Working Group (ten major epidemiological
studies scheduled for completion by 1990 and five ongoing
health surveillance projects), one is complete. It is the
9: 2

�Birth Defects Study carried out by the Center for Disease
Control. This study has two conclusions: the tfirst conclusion was that there is no association between service in
Vietnam and birth defects. The second conclusion was th,a,t
there may be an association between opportunities for exposure,
to Agent Orange and a handful of birth defects, As soon a,s the
results of that study were released, at least one bill was
written in the Senate which was to provide compensation to all
veterans who had fathered children with spina bifida, a. colleC"
tion of tumors,and cleft lip with or without cleft palate,
That legislation never left the Senator's office. The
people who had clone the study at the Center for Disease Control, i.e., Dave Hricson and his colleagues, came to Congress.
They talked to congressional staff in great detail about the
structure of the study, its strengths and limits, and how to
draw conclusions from its results. They also went to the
American Legion, the Disabled American Veterans, the Vietnam
Veterans of American, and other veterans organizations, where
they explained the study and convinced those veterans that the
connections that had been shown, although theoretically valid,
woulcl not make a great deal of sense biologically. This was
a great achievement for solid scientific exposition and
convincing people not to be afraid and consequently do something foolish.
Some scientists still argue about the meaning of those
possible connections between exposure to Agent Orange and
birth defects. The Birth Defects Study, like many of the other
Agent Orange studies, was clone for political reasons. Politically, it has been examined and tried. The Congress looked at
the conclusions and decided no harm had been associated with
Agent Orange. So the CDC Birth Defects Study, from the point
of view of politics, is over. The Congress will not reopen it.
9: 3

�It is Interesting to note in this context that in the
Agent Orange lawsuit which was settled in the District Court
of New York in May, 1985, Judge Weinstein also considered the
CDC Birth Defects Study. He reached the same conclusion as
Congress, deciding that the study results were not sufficient
to sustain any association between Agent Orange and birth
defects. Thus, in the judicial system also, the CDC Birth
Defects Study has been weighed and found not to be convincing
in demonstrating any association between Agent Orange exposure
and b i. r th de f e c t s .
These are events which are very important. It should be
kept in mind that here we are not dealing with a purely scientific issue but with very sensitive and complicated political
and social issues. The scientific conclusions, therefore,
\vhile they are very important to us to understand whether or
not: d.i.oxin and Agent Orange cause disease, still are less
important to society than the decisions that are made in the
courtrooms and in the Congressional Hearing Rooms.
To come back to OTA, Congress wrote OTA into the Agent
Orange study because of disagreement between the Senate and
House Committees on Veterans' Affairs. Sensitive to veterans'
complaints that the Veterans Administration was indifferent
to their claims of harm from Agent Orange, the Senate wanted
the study to be carried out by some other agency. The House
Committee, on the other hand, had more faith in the Veterans
Administration and acted to preserve Veterans Administration's
responsibilities for research on veterans' health. The two
committees compromised, giving responsibility for the study
to the Veterans Administration and mandating that the Office
of Technology Assessment make periodic reports to the
committee, keeping Congress informed about progress or lack
o f i t.

9: 4

�This was an entirely new role for the Office of Technology
Assessment, and its constitutionality has been questioned. The
question arose a month after Congress directed the Veterans
Administration to do the Agent Orange study. At that time,
Congress passed another law directing the National Institute
for Occupational Safety and Health to do a study on dioxinexposed workers, and, again, Congress required that the Office
of Technology Assessment review and approve the protocol and
monitor the conduct of the study.
President Carter vetoed that law on the basis that
giving a congressional branch agency--the Office of Technology
Assessment—veto authority over the execution of an Executive
Branch study was a violation of separation of powers doctrine,
Executive Branch lawyers concluded after examining the case
that the bill was unconstitutional. Legislative Branch lawyers,
however, concluded that it was constitutional. Neither branch
has taken the case to court, and the issue is unresolved.
The veto of the NIOSH bill was successful.
President Carter's veto message also instructed the
Administrator of the Veterans Administration to ignore the
provisions of Public Law 96-151 which directed the Veterans
Administration to submit the study plan to the Office of
Technology Assessment for review. However, Senator Alan
Cranston, at that time Chairman of the Senate Committee on
Veterans' Affairs, wrote the Administrator that ignoring the
provision would not be a wise course. He pointed out that
Congress must provide funds for the Veterans Administration
study and that funding depended, on the Office of Technology
Assessment reviewing and approving the study plan. The Office
of Technology Assessment was part of the process, and it has
played an active role in Agent Orange issues ever since.

9: 5

�OTA assembled an Advisory Board to participate in its
Agent Orange activities. The panel includes academics--epidemiologists and statisticians, a toxicologist, a neurologist,
and a gynecologist. Then there are members who represent
stakeholders. There are three representatives from chemical
companies that made the Agent Orange components: Monsanto,
Dow Chemical, and American Cyanamid. They are neatly balanced
by representatives of the American Legion, the Disabled
American Veterans, and the Vietnam Veterans of America.
Despite the congressional requirement that a protocol
be written in 180 days, the Veterans Administration did not
produce one within that time. The Veterans Administration
was sued by veterans' groups because of some of its procedures.
There was a hearing before the General Accounting Office about
the methods used by the Veterans Administration to contract
for the protocol design. All of these events contributed to
the protocol's being late.
When the Office of Technology Assessment received the
first draft of the protocol, we rejected it as inadequate.
The basic plan of the protocol was to compare morbidity and
mortality rates between two groups of veterans, one which had
been exposed to Agent Orange and one which had not been.
In response to OTA's and others' criticisms, the protocol
was revised. The revision process just dragged along. It
was not until September, 1982, two and a half years after
Congress passed the law, that OTA approved the protocol.
By that time the Agent Orange Working Group Science Panel
had become convinced that it was really impossible to separate
exposed from not- exposed veterans, and they were urging that a
study be done to compare the health of veterans who had gone
to Vietnam with the health of veterans who have not gone to
to Vietnam, A study of that type would at least provide a

9: 6

�clue as to whether or not Vietnam veterans in general were
suffering from ill effects as a result of that experience.
The recommendation placed pressure on the Veterans Administration to do a "Vietnam Experience Study" even though the
Administration was planning an Agent Orange study.
Rather than making a decision between the two studies on
its own, the Veterans Administration asked for another review
of their protocol from the National Academy of Sciences. In
September, 1982, all the delay came to a head because Congress
had exhausted its patience. One hundred and: one representatives from the House of Representatives wrote a letter to the
Veterans Administration requesting that the study be transferred from the Veterans Administration to some other agency.
Dr. Vernon Monk of the Centers for Disease Control, in testifying before the House Veterans' Affairs Committee, said that
the Centers for Disease Control was well placed to do the
study. The Senate Veterans' Affairs Committee reaffirmed its
previously held conviction that the responsibility for the
study should be transferred somewhere else. The result was
that the execution of the study was taken from the Veterans
Administration and given to the Centers for Disease Control.
The Centers for Disease Control finally resolved the controversy about whether to do an Agent Orange Study or a Vietnam
Experience Study: they are doing both.
The CDC studies are the largest, probably the most compjLicated, and the most expensive epidemiology studies ever
conceived. They will cost at least $70 million, involve
interviews of 30,000 veterans, and 10,000 physical examinations to be carried out at the Lovelace Clinic.
The Vietnam Experience Study is relatively straightforward. Looking at the records easily establishes whether
or not a veteran went to Vietnam. The two cohorts can thus
9: 7

�be easily assembled, with the men who went to Vietnam on one
side and those who did not on the other; then their health
can be examined. The Vietnam Experience Study is underway and
on schedule. The same cannot be said about the Agent Orange
Study,because it is much harder to say whether or not a
veteran was exposed to Agent Orange. In January, 1985, the
Centers for Disease Control sent the Office of Technology
Assessment a summary of their efforts to resolve the exposure
problem. At that time the Centers for Disease Control were
able to identify the locations of battalions on the ground
in Vietnam,
A battalion is about 1,000 men, four maneuver companies
and a headquarters company. The battalion that the Centers
for Disease Control provided as an example was spread out along
a line of 40 kilometers. It was not possible to know where
the 1,000 men actually were. Were 990 at the middle of the
line or were they at one end? Were they spread out evenly
along the entire line? No one knows. One way to decide that
a battalion was exposed is to declare that any Agent Orange
spray mission within a fixed distance caused exposure. In
practice, AOWG and CDC have accepted that a spray mission at
a distance of two kilometers'might result in exposure.
Now consider an airplane spraying Agent Orange somewhere
within two kilometers of the battalion spread out on the 40
kilometer line. It is very hard to say who of the battalion
was exposed and who was not. Even assuming that exposure
could be ascertained, it is impossible to know how much
exposure took place.
OTA was very critical of the plans to decide a battalion
was exposed on the basis of such data. This criticism was expressed in periodic reports sent to the congressional committees.

9: 8

�Right: now, I think a majority o£ the OTA Advisory Board
feels that the study on Agent Orange should not go on because
of difficulties in deciding who was exposed and who was not.
The panel has not voted on this issue, and I could be wrong,
in my assessment, but I don't think so, If, after seeing
more details about exposure, OTA decides the study is impossible,
Congress could decide not to do the study. That would involve
an act of courage on the part of the Congress because it has
made a commitment that this study would be done. The Veterans'
Affairs Committees of the Senate and of the House may face the
dilemma, having promised the veterans to do the study, that
they have changed their mind. I used to think that, no matter
what the technical problems, the study would be done. I am
no longer so certain.
Congress has considered, over and over again, providing
compensation to veterans who claim ill effects from Agent
Orange exposure. At one time there was a list of over 20
diseases being considered as compensable. Congress finally
passed a law which provides compensation for chloracne and
porphyria cutanea tarda (PCT), if they occurred within one
year after .leaving Vietnam, Although there are very few
cases of either disease, the law was not a hollow gesture
on the part of the Congress. They wanted to do something
to compensate veterans who had been harmed, but, at the same
time, they wanted to limit compensation to diseases that
might be connected with Agent Orange,
Subsequently, Congress directed the Veterans Administration
to set up a special committee to review claims about diseases
resulting from Agent Orange exposure. That committee will
function only until the studies of the Centers for Disease
Control arc complete, because at that moment we expect to
have the answer to our questions.

9: 9

�Summing up, we can say that Congress is working out the
Agent Orange controversy. In 1979, Congress refused to make
a decision about whether or not Agent Orange had caused health,
effects. Instead, Congress directed the Executive Branch
to gather information for making a decision. By now, some
results have come in. The Air Force's studies on Ranch Hand
personnel provide no convincing evidence that Agent Orange
has affected human health. The Birth Defects Study, performed
by the Centers for Disease Control, also failed to provide
convincing evidence of a connection between Agent Orange and
human effects. Congress has directed the Veterans Administration to compensate two conditions which have been related to
dioxin exposure should they appear in Vietnam veterans. The
judge in the Agent Orange class action stated that the veterans
had failed, to prove their case in court that Agent Orange was
the cause of their illnesses. These points are convincing
many people that, regardless of all the fears about Agent
Orange and the toxicity which might reside in the dioxin
molecule, exposure to Agent Orange, if it occurred, has not
harmed the veterans.
However, that is not yet the end of the Agent Orange
controversy. Intellectually and emotionally the veterans
might accept that they have not been able to prove that their
diseases were caused by Agent Orange, but they can always
contend that no one could prove the contrary.
Probably, Agent Orange will pass away as a political
issue. Some veterans will continue to contend they were
harmed, but the decisions already made in Congress and in
the courtroom will convince many people that no detectable
harm was done. As more study results come in, if the results
continue to show no health effects, they will reinforce the
conclusions already made.

9: 10

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                    <text>Item ID Number

°1488

Author

Gross, Michael L.

Corporate Author
Report/Article TltlB Typescript: Analysis for 2,3,7,8-Tetrachlorodibenzo-pdioxin in Adipose Tissue from Vietnam Veterans

Journal/Book Title
Year

oooo

Month/Day
Color

n

Number of Images

15

DBSCrlptOn Notes

Draft version. See item 690 for published article.

Tuesday, May 15, 2001

Page 1488 of 1514

�DO. A FT
A n a l s i s for 2, 3,7,
in Adipose Tissue from Vietnam Veterans,

by
Michael L.Gross, Jackson O. Lay, Jr., Philip A. Lyon,
Dixie Lippstreu and Nancy Kangas
Department of Chemistry
University of Nebraska
Lincoln, NE 68588
Robert L. Harless and Scott E. Taylor
U.S. Environmental Protection Agency
Health Effects Research Laboratory, ETD, ACS, MD-69
Research Triangle P a r k , NC 27711
Aubry E. Dupuy, Jr.
U.S. Environmental Protection Agency
OPTS/OTS, Exposure Evaluation Division
Field Studies Branch
Toxicant Analysis Center
Bay St. Louis, MS 39529

�— 2 -*

ABSTRACT

Tetrachlorodibenzo~£-dioxin
ranging from

(TCDD) has been detected at levels

20-173 parts-per-trillion in adipose tissue from three

Vietnam veterans who were "heavily exposed" to Herbicide Orange.

The

detection corresponded to a single isomer, having the characteristics
of 2,3,7,8-TCDD, and was validated in inter laboratory studies for two
of

the

three

tissue

samples.

Tissue samples

from

other

Vietnam

veterans and from controls also contained 2, 3, 7, 8-TCDD at levels below
20 parts-per-trillion.

These findings are in accord with uptake and

long term storage of 2,3,7,8-TCDD by veterans who experienced a heavy
exposure

to

Herbicide

Orange.

Furthermore,

they

may signal

accumulation of 2, 3, 7, 8-TCDD in some members of the U.S. population.

Aerial defoliation

in Vietnam carried out by the United States

military from 1962-1970 made use of Herbicide Orange/ a 1:1 mixture of
the

herbicides

contaminant,

2r4,5-T

and

2,4-D.

The

2,4,5~T

2, 3,1, 8-tetrachlorodibenzo-p_-dioxin

contained

(2, 3, 7, 8-TCDD)

a
at

levels sufficient to produce a mean concentration of about 2 partsper-million in the defoliant.

The ,.2f 3, 7, 8-TCDD, in addition to being

extremely toxic, is known to be carcinogenic and teratogenic in animal
2
tests.
Vietnam veterans now claim adverse chronic and delayed health
effects related to their exposure to Herbicide Orange.

These claims

and recent publicity regarding the m i l i t a r y defoliation program have
increased public awareness of the potential health e f f e c t s of exposure
to 2,3,7,8-TCDD, especially among Vietnam veterans.

�- 3 -

.

We report here the results of a preliminary study designed

to

determine the range of TCDD levels that might exist in the tissue of
veterans.

Specifically, we wished to determine if 2,3,1, 8-TCDD could

be detected at levels above 1-5 parts-per-trillion.
was

chosen

as

the

preferred

sampling medium

Adipose tissue

because

of

its

good

accessibility (compared to other tissue) and because 2,3,7,8-TCDD is
O

known to accumulate in this tissue in other species. '
wished to

examine whether any correlation exists

A

Secondly, we

between exposure

(assigned by the Veteran's Administration ) and observed levels.
existence

of

a

correlation

could signal

the

need for

The

additional

monitoring studies.
In order to have confidence in the results generated from test
samples, it

is

necessary to demonstrate

'analyses of TCUD at low ppt levels.
laboratories

involved

in

this

the capability to conduct

This has been demonstrated in the

analytical

work

by means

of

blind

validation studies in which coded spiked samples of beef fat and human
milk were analyzed. '

Additional validation of the methodology used

in this study for low levels of TCDD has been demonstrated at the 1100 part-per-trillion range using human and beef adipose tissue

(see

Table 1) .
The Veterans" Administration supplied thirty coded samples of
adipose tissue which had been surgically removed from the abdominal
area of "exposed" veterans and control subjects who had not served in
Vietnam.

Additional

tissue

was taken from

three U.S. Air Force

officers with several years experience in TCDD research.

Particular

care was exercised, even in tissue removal, to avoid any potential
contamination.

The samples were placed in rigorously cleaned glass

�- 4 -

vessels, f r o z e n , shipped in dry ice, and stored in a f r o z e n state (20 C) .

No disinfectants

containing

hexachlorophene

or

other

trichlorophenol-based materials were used.
Approximately 5 to 10 grams of tissue were used, when available,
for

each

analysis.

standard (either

37

A known amount, generally

the adipose tissue.
hydroxide followed
hexane

extract

13

Cl-2, 3,1, 8-TCDD or

by extraction
was

involved the use of

resolution
employed

gel,

washed

for

internal

C-2, 3, 7, 8-TCDD) was added to

with hexane to

with

remove TCDD.

concentrated
The final

sulfuric

The
acid,

stage of clean-up

three short-column liquid chromatography steps

alumina,

mass

of

The sample was digested in alcoholic potassium

neutralized, d r i e d , and concentrated.

(silica

2 ng,

and

Florisil).

spectrometry

quantitation

(as

of

Q

Gas

described

2,3,7,8-TCDD

chromatography/high
previously 8 ' 10) was

and coeluting

isomers.

Signal profiles were obtained at a mass resolution of 10,000 for m/z
321.8936,

the

most

abundant

molecular ion

for

TCDD,

and for

the

internal standard mass by signal averaging for approximately 100 sec.
commencing with the

appearance of

the co-eluting internal standard

2, 3, 7, 8-TCDD.
/ Extracts which contained materials giving signals greater than
2 . 5 times noise at

the exact mass of TCDD

(i.e. 321.8936 ± 0.0020)

over the integration period discussed above were reanalyzed.
second analysis,

signal profiles

of

For the

m/z 321.8936 and m/z 319.8965

were monitored over the elution period of 2,3,7,8-TCDD (determined by
injection of standard solutions).
if

A positive detection was reported

signals were observed above the detection limit ( 2 . 5 times noise)

and if their intensity ratio was 1.0:0.78 + 0 . 1 0 , which is consistent

�- 5 -

with the presence of
meeting all

four

chlorine atoms in the molecule.

Samples

criteria except the correct isotope intensity ratio have

been considered to contain "not detectable" levels of TCDD.

For these

samples, we judged that the presence of TCDD is not disproved by the
observation of an incorrect isotope ratio at these low concentrations;
r a t h e r , the presence of TCDD is not confirmed.
For

the

quantitation
Nebraska,

of

all

stage

considered
the

Two of
"heavily
highest

of

analyses,

samples were

Midwest Center

results) .

contain

first

the

for

exposed"

conducted at

Mass

three

Spectrometry

samples

to

both

extraction

the
(see

and

U n i v e r s i t y of
Table

2

for

tissue from veterans
Herbicide Orange 12 were found to

levels of TCDD

of

detected

in

this study.

The

recovery (20%) of internal standard for the tissue sample of the t h i r d
"subject was un-acceptably low.
values,

We consider the levels to be minimum

and the higher level, in cases of replicate analysis,

is

judged to be more accurate.
This is because the internal standard
37
signal for
Cl-2,3,7,8-TCDD at m/z 327.8849 is susceptible to an
35
37
interference from m/z 327.8775 (C-, 2 H 5 Cl, C12) , a molecular ion of a
polychlorinated biphenyl, which could enhance the

intensity of

the

standard and lead to the calculation of too low a value for the TCDD
using the internal standard method of quantitation.
Three of

five

samples of

tissue from

veterans

having "light

exposure" were found to contain TCDD, as were tissue from two of the
three

Air

Force

officers

who have

done

extensive

research

environmental and biological samples containing 2,3,7, 8-TCDD.

with
Seven

of thirteen tissue samples from other Vietnam veterans were found to
contain 2,3,7,8-TCDD or coeluting isomers at levels between 3 and 13

�- 6-

parts-per-trill ion.
Samples

taken

from

veterans who had no service

in

Vietnam

(controls) also showed low levels of TCDD (four of ten were judged to
be "positive" at levels between 4 and 8 parts-per-trillion).
In view of the limited isomer specificity 14 of the methodology
used at the University of Nebraska (UN-L)
certainty

by interlaboratory validation

these low levels, a subset of
and/or

reanalyzed

at

other

the

and the need to increase
of

reported detections

tissue samples was reextracted

laboratories

(see

interlaboratory validation was done in two ways.
the

first

stage

of

analyses

at

at

UN-L were

Table

3) .

The

First, extracts from
reanalyzed

at

the

Environmental Protection Agency laboratory at Research Triangle Park
(RTP) using capillary column gas chromatography/high resolution mass
spectrometry (reported as UN-L/RTP in Table 3) .
the

tissues

stored

in

the

University of Nebraska

transmitted to the EPA Toxicant Analysis Center
and

clean-up.

The extracts

were

then

Triangle Park laboratory for analysis
3) .

Second, portions of
laboratory were

(TAG) for extraction

forwarded

to

the

Research

(reported as TAC/RTP in Table

All samples were coded at the University of Nebraska and their

identities were not known to the workers at TAG or RTP.
The tissues were extracted at TAG using methods similar to those
employed at the University of Nebraska.
the

RTP laboratory made

use

of

The quantitation conducted at

capillary

column GC and peak-top

monitoring (rather than peak profiles) at a mass resolution of 600010,000,

a method more specific for TCDD isomers than that employed at

the University of Nebraska.

All detections reported in Table 3 were

for a material having an identical GC retention time as 2,3,7,8-TCDD

�_ 7 —

and no other isomers were detected at levels greater than 10% of the
level corresponding to 2, 3,1, 8-TCDD.

Some small degree of uncertainty

remains that the material detected is the 2,3,7,8-TCDD isomer because
standards for

all

22 TCDD

isomers

were

not

available

at

the

RTF

laboratory.
Based
confirmed

on the

that

interlaboratory

two of

three

validation

samples

from

studies,it

veterans

is now

designated as

having "heavy exposure" were found to contain measurable amounts of
2,3,7,8-TCDD at levels higher than any other participant's tissue in
this study.
is

Adipose tissue from the third "heavily exposed" veteran

a "possible positive";

i.e./

the positive detection made by RTF

scientists was not validated by the

group at

Nebraska, presumably

because of the problem with recovery.
Both the TJSAF officers'" adipose tissues, which were examined in
the interlaboratory validation, definitely contained 2,3,7,8-TCDD, but
at lower levels than the tissue of "heavily exposed" veterans.
Definite detections of 2,3,7,8-TCDD were made in the analyses of
adipose tissue from

other

exposed veterans and veterans who never

served in Vietnam (controls).

The detection of 46 ppt for VA-21 is

considered an aberrantly high value based on a comparison with four
other analyses reported in Table 3.

Ignoring this value, the highest

level detected in these two groups (20 ppt) coincides with the 1owest
detection made for the "heavily exposed" veterans.
may signal

base-line accumulation of

TCDD

in

These observations

some members of

the

general U.S. population.
There is good agreement of the results obtained in both mass
spectrometry laboratories

particularly in terms of the assignments o£

�- 8 -

whether the sample contains TCDD.

Differences in concentrations were

found for repeated analysis of samples containing the higher levels of
TCDD.

These d i f f e r e n c e s appear to be systematic;

concentrations

determined

explained above.
difficulty

of

by the

Nebraska

for example, the

workers may be low

as

This lack of agreement is expected considering the

performing

concentrations.

extractions

and

Accordingly, we do not

analyses
consider

at

these low

the

differences

obtained for a given sample to be significant.
Because TCDD could be detected in some control samples, a simple
statistical

analysis

was used to test the significance

of the

4

results.

A contingency table for the hypothesis of independence was

used' to test the supposition that "concentration levels of TCDD in
adipose

tissue

of

test

Herbicide Orange".
were

used

except

individuals

is

unrelated

to

exposure to

The exposure classifications as previously listed
the

Air

Force

scientists

were

excluded.

concentrations of TCDD were classified in four categories:

The

(1) "less

than four parts-per-trillion or not detected", (2) "4 to 10 parts-pertrillion", (3) "11 to 20 parts-per-trillion", and (4) "greater than 20
parts-per~trill ion".
statistical

The

concentrations

test were averages of. all

detected"

having

detection limits

used

in

the

in both

We did not use reports of
greater

positive detection made in separate analyses
The "not detected"

TCDD

determinations made

laboratories with the following exceptions.
"not

of

than or

equal

to

(see VA 8, 9, 19, 34) .

assignments of samples having low recoveries of

internal standard (VA 18 and 19, Table 2) were not used.

Finally,

determinations which appeared to be positive but yielded

incorrect

isotope ratios (see Table 2) were considered as "not detected" except

�_ 9 —

when another analysis showed that the
third

concentration

"heavily

classification

exposed" veteran"*s

positive"

(VA 19)

and

tissue

the

of

the

other

two

"heavily

considerably higher in all
which fall

was chosen

to

The

encompass

the

which was considered "possible

control

concentration of TCDD (VA 2 0 ) .

sample contained TCDD.

sample

having

the

highest

The levels of 2,3,7,8-TCDD in tissues
exposed"

veterans

were

found

to

be

analyses, and they were the only results

in the f o u r t h category.

The chi-square test showed that

the hypothesis of independence was false at the 95% confidence level,
indicating

a

correlation

between

degree of

exposure to Herbicide

Orange and tissue levels of 2,3,7,8-TCDD.
In conclusion,
Administration a&lt;3
levels

of

Vietnam

veterans

"heavily exposed"

2,3,7,8-TCDD

in

designated

by the

Veteran's

to Herbicide Orange

carry low

adipose

interlaboratory analytical studies.

tissue,as

validated

in

The 2,3,7,8-TCDD levels found in

these veterans are higher than for other exposed veterans or for the
controls.

The observations

that

the

TCDD

observed

is

a single

isomer, and likely the 2,3,7,8-isomer found in 2,4,5-T, and that the
levels in the "heavily exposed" group are higher than those observed
in any of the other study cases are in accord with an interpretation
that

the

exposure occurred

in

Vietnam.

We emphasize

that

the

confidence ascribed to this conclusion can'be increased (or decreased)
by conducting a more thorough investigation which would include a
larger
Orange.

sample of

Vietnam

veterans

"heavily

exposed"

to

Herbicide

�- 10 REFERENCES

i tion
of
Orange
Herbicide
by
Incineration,
Final^
^
^
Environmental Statement, 36 (Department of the Air Force, November
1974) .
2.

For a review, see M.P. Esposito, T.O. Tiernan, F. E. Dryden,
Dioxins (Research Reporting Series EPA-600/2-80-197, Industrial
Environmental
Research
Laboratory O f f i c e
of
Research and
Development, United States EPA, Cincinnati, Ohio, November 1980).

3.

T.A. Gasiewicz, R.A. Nealy,

4.

G. Reggiani/ The Estimation of the TCDD Toxic Potential ir± the
Light of the Seveso Accident.
Presented at the 20th Congress of
the European Society of Toxicology, West Berlin (1978) .

5.

L. E. Lee, P. Donahue, H. B. Greenlee, C. R. Mota, W. Schumer , P.
A. Thomas, J r . , Science, submitted with this manuscript.

6.

R. L. Harless, E.O. Oswald, M. K. Wilkinson, A. E. Dupuy,
D.D. McDaniel and Han Tai , Anal. Chem. , 52_, 1239 (1980) .

7.

R. G. Heath, Int erl a bo r at or y Method Validation Study for Dioxin,
An Interim Report , (United states EPA, Human Effects Monitoring
Branch, O f f i c e of Toxic Substances, Washington, DC, 1979) .

8.

M. L. Gross, Tung Sun, P. A. Lyon, S. F. Wojinski, D. R. Bilker, A.
E. Dupuy, R. G. Heath, Anal . Chem . , in press.

9.

R. W. Baughman, M. Meselson,
5_, 27 (1973) .

Fed. Proc.

37, 501 (1978) .

Envi ronmental

Jr.,

Health Perspectives^

10. B. J. Kimble, M. L. Gross, Science, 207, 59 (1980) .
11. A number of method blanks (14) were extracted and analyzed with
actual tissue samples so that one blank for approximately every
three samples (including repeats) was examined.
No TCDD was
detected in the blanks at at an^average detection limit of 4 and a
range of 1 to 11 parts-per-trillion.
12. The classification as to degree of exposure was made by the U . S .
Veterans Administration (see reference 5) .
13. The packed column used in these studies has been evaluated by Dow
Chemical Company scientists in terms of TCDD isomer specificity
(see reference 15). In our hands 2, 3, 7, 8-TCDD, for example, could
be separated from 1,3, 6, 8-TCDD with base line resolution.
14. Another interlaboratory study, TAC/RTP, was conducted prior to the
two reported in table 3.
Analysis of method blanks showed that
the glassware in the TAG laboratory was contaminated w i t h 2 , 3 , 7 , 8 TCDD and other isomers at the time of the study. None of these
results are reported h e r e .
All glassware was replaced for the

�- 11 later studies, which yielded the results given in table 3.
Actual adipose samples VA-9 and 10 were presumably contaminated
d u r i n g the time of the f i r s t extraction at TAG as they were found
to contain 160 and 230 ppt respectively in the second TAC/RTP
validation run (coded TCDD TAC/RTP ) . These results are also not
reported in Table 3 because they are clearly not consistent w i t h
results of other analyses of these samples. Samples VA-26 and VA31 were not present in the TAG laboratory at the time of
contamination. They and additional portions of tissue samples for
the t h i r d validation run (Coded TAC/RTP ) were transmitted to TAG
after the laboratory contamination had been removed.
15. T. L. Nestrick, R. S. Lamparski, R. Stehl, Anal. Chem.
(1979) .

51, 2273

16. E. W. Minium, Statistical Reasoning in Psychology and Education,
(John Wiley and Sons, New Y o r k , 1970), p. 438. We thank Professor
Y. L. Tong of the University of Nebraska-Lincoln for helpful
discussion of the statistical methods.
17. We thank Dr. James Norman and Dr. Lawrence Hobson for helpful
discussions.
This work was supported by the National Science
Foundation Regional Instrumentation Facility Program (grant number
CHE7 8-185 72) , by the Veterans Administration, and by the U . S .
Environmental Protection Agency.
The contents of this paper, do
not necessarily reflect the views or policies of any of these
agencies. -

�Table 1. Analysis of Control Samples for TCDD.
Nature of
Sample
Human
Human
Human
Human

Fat
Fat
Fat
Fat

Sample Wt.

(g)

Spike
(ng)

Concentration1
Added (ppt)

14.80
14.80
14.70
15.55

2.00
2.05
2.00
2.00

0
6
16
38

9.91
10.44

1.00
1.00

2
96

Concentration
Found (ppt)
nd
9
20
41
3

Beef Fat
Beef Fat

1. ppt = parts-per-trillion
2. recovery of internal standard
3. average of two analyses
4. average of three analyses

1 + .1

75 + 5 *

Detection
Limit
3
3
4
4
0.5

3

Percent Recovery
40
40
45
40

120
60

�Table 2. Results of Stage 1 Analysis of TCDD in Human Adipose Tissue1
VA- Code
Number

Concentration
(PPt)2

Percent Recovery

Ratio3

4
9
3
10
6

65
100+
20
90
45

.85
.75

5
2
4
5
6
3

50
80
50
95
40
100

3
3
3
2
3
3
4
3
4
4
3
6
5

65
50
40
55
60
65
60
80
45
45
100+
100
60
95

.90
.90

4
2
3
4
4
3
2
3
4
4
7

65
60
75
30
50
35
100
55
50
60
100

1.02
.92
.84

Detection Limit
(ppt)

"Heavily Exposed Veterans"
10
10
19
26
26

23
35 2
ND
99
63

"Lightly Exposed Veterans"
1
ND
13
ND
15
7
28
7
28
8
34
5

.77

.78
.85

"Possibly Exposed Veterans"

6
8
' 9
11
12
14
16
24
24
25
25
27
29
30

5
51
ND
3

9
4
ND
5
5
12
10
ND
13
ND

.77
.88
.74
.71
.78
.88

"Controls"

5
7
17
18
20
21
23
23
31
32
33

4
3
4,3"
ND
5
6
8
6
7
4
14

.86
1.07
.78
.98
.74
.94

�Table 2 continued.
VA Code
Number

Concentration
(ppt)2

Percent Recovery

Ratio3

50
85
50

Detection Limit
(ppt)

.77
.94
.76

"USAF Scientists"

2
3
4

5
4
6

2
1
2

1. Sample sizes ranged from 2.2 - 11. 6g for each extraction.
Internal standard amounts used varied from 2.0 - 2.6ng/extraction.
2. ppt = parts-per-trillion; ND = not detected.
3. Ratio of intensities of m/z 320 and m/z 322.
4. Duplicate analysis of same extract.

Acceptable values are 0.78

0.10.

�Table 3. Results of Interlaboratory Validation Studies.
VA Code

UN-L/UN-L'

UNL/RTP

36

UN-L/UN-L*

TAC/RTP'

173
h

"Heavily Exposed Veterans"
VA-26
VA-10
VA-19

63,99
23,35
ND(3) e

86
20

ND(29)

USAF Researchers
VA-3
VA-2

4g

3"

10

5

....

....

24

Other Vietnam Veterans
VA-13
VA-8
VA-9
VA-15
VA-34

ND(2)
5
ND(3)
7
5

ND(0.2)
3
3
.. _
.

ND(7)
5
h
____

5
3

20
8
12
ND(3)

-.«.__

..
..

. .
.
.

ND(7)
18
ND(5) f

..
..

Control s
VA-17
VA-18
VA-21
VA-31
VA-20

4,3
ND(4)f
69
ND(4)
5

....

•

14

....

46

9

19

20

Notes:
(a) Extracted at UN-L/Analyzed at UN-L (from Table 2). The values given in parentheses
are the detection limits.
(b) Portion of the Extract from UN-L/Analyzed at RTP
(c) Extracted at TAC/Analyzed at RTP
(d) Another portion of tissue shipped from UN-L, extracted at TAC/Analyzed at RTP
(e) Extracted at UN-L/ Analyzed at UN-L. Results obtained with knowledge of the code.
(f) Poor recovery of internal standard (&lt;40%).
(g) Isotope ratio for m/z 320 and m/z 322 not correct,
(h) See footnote 14 regarding these samples.

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                    <text>Item ID Number

°1566

Author

Hobson, Lawrence B.

Corporate Author

Veterans Administration

RBpOPt/ArtfClB TltlB Memorandum: from Clinical Assistant (102A) to Acting
Dir. Agent Orange Projects Office (10A7), with subject
Ranch Hand, Advisory Committee, September 28,1982.

Journal/Book Title
Year

000

°

MontD/Day

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Descrlpton Notes

Wednesday, May 23, 2001

Page 1567 of 1608

�Veterans
Administration
Date:

October 20, 1982

Memorandum
From:

Clinical Assistant (102A)

Acting Dir. Agent Orange
lo:

Projects Office (10A7)

Subj.

Ranch, Hand, Advisory Committee
September 28, 1982

1. On September 28, 1982, the Advisory Committee on Special Studies
Relating to the Possible Long-term Health Effects of Phenoxy
Herbicides and Contaminants (the Air Force Ranch Hand study) met at
NIEHS, Research Triangle Park, NC. The purpose was to review the
progress of the study.
2. Dr. J.A. Moore chaired the session with Drs. I. Selikoff,
R. Monson, A. Poland, G. Comstock, and N. Nelson, members in
attendance. Aside from Air Force personnel and me, the only
attendees were Maureen Corcoran and Margaret Warner, the latter a
lawyer from Carr, Jordan, Coyne, and Savits.
3. To date more than 1,000 participants have been examined with
only one serious complaint (nature unspecified). An attempt is
underway to obtain military records and private medical records for
all.
4. Serum (20+cc.) and urine (100 cc.) from each participant are
being retained at - 70°C. Selikoff suggested needle fat biopsies to
obtain 500 mg, of material for storage. This suggestion was
rejected, as it had been before, despite Poland's skeptical report
that Rappe claims measurement in tissue with less than 1 ppt. (less
than 0.1 nanagram) of TCDD. Nelson believes that even smaller
amounts (1 femtogram) can be measured by immunological techniques.
He suggested that red blood cells should be stored since hemoglobin
has proved to be an effective long-term adsorbant for a variety of
chemicals.
5. The morality study, as expected, is showing a death rate below
that for the U.S. population control and equal among Ranch Handers
and their Air Force controls. Analysis of causes of death is not
yet complete and, in any event, the numbers are very small, limiting
the significance of differences (all P's equal to or greater than
0.05).
6. Only 3 Ranch Handers have died from malignant neoplasms, less
than half the rate among controls; 5 died of gastrointestinal
diseases, more than twice the rate among controls. Three
participants are 5 year post-operative survivors of testicular
carinoma but the code has not been broken to determine whether they
are in the exposed or the control cohort.

�7. No chloracne has been observed. Selikoff said that 50 percent
(sic) of the the chemical workers at Nitro who had cloracne
initially still had it 30 years later and that this indicates severe
exposure; laborers who cleared a dump site at Jacksonville,
Arkansas, had no chloracne.
8. An attempt is being made to develop an exposure index for Agent
Orange. The Ranch Banders include individuals who were exposed to
320,000 to 1 million gallons of all herbicides a maximum to 100
gallons as a minimum.
9. Of 1,265 Ranch Banders, 22 were killed in action, 38 are dead of
other causes, and 1,205 were alive on December 31, 1981. The search
for these has resulted in 1,160 cooperative participants, 39 who
refused participation, and 6 who are still not located. The
corresponding numbers for controls are 1,149, 81, and 10. Of the
Ranch Banders it is anticipated that 90 percent will complete the
examination at best, 75 percent at worst; for controls the
percentages are 82 and 65. Lack of time and interest is the most
common reason given for refusal.
10. The immunology testing of a subset of 600 participants was
discussed at length. The Air Force has not included skin tests as
unreliable or dangerous; Selikoff believes that the decision should
be reconsidered.
11. Among laboratory tests, BDL is the least reliable, although BUN,
total and conjugated bilirabins are also poor,. Electrophoresis
studies are also variable but this was shown to be within the
accepted limits of general experience.
12. The study remains on schedules Mortality results will be
available in March, 1983; an interim report on morbidity in April to
June 1983* The next Committee meeting will be in March, 1983, to
consider the mortality data and perhaps the exposure index
determinations.

\ ••.&lt;.,*&lt;:&lt; ''O.
&amp;
LAWRENCE B. HOBSON, M.D.,

Ph.D.

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&lt;p&gt;For more about this collection, &lt;a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a"&gt;view the Agent Orange Exhibit.&lt;/a&gt;&lt;/p&gt;</text>
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