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RODOrt/ArtlClB TltlO Typescript: Updates on various Vietnam Veteran Health
Studies, March 11, 1987

Journal/Book Title
Year
Month/Day
Color

n

Number of Images

3

Desorlpton Notes

Tuesday, May 15, 2001

Page 1437 of 1514

�Vietnam Veterans Mortality Study:
The study was designed to assess mortality patterns ot U.S.
servicemen in the Army or Marines who served during a portion of
the Vietumn era (1965-1975). A sample of 75,000 veteran deaths
was selected from the VA files. For each of the veteran deaths,
military service and cause of death information were collected
and coded. The two types of data were merged and analysed to
compare the mortality experience of veterans who served in
Vietnam with veterans of the same era who did not serve in
Vietnam. This study began in December 1982 and the final report
was completed in December 1986.

Updato of the Vietnam Veterans Mortality Study:
The Vietnam Veterans Mortality Study (WMS) will provid© the
initial data on the mortality patterns of veterans who served in
Vietnam and those who served elsewhere. However some of the
diseases that were suggested as being associated with Agent
Orange exposure or Vietnam service may take a long time to
develop. For example, it takss about 20 years for certain
cancers to manifest themselves if they are caused by
environmental chemicals such as Agent Orange. We plan to
periodically update the mortality data and monitor Vietnam
veteran® mortality patterns.
Retrospective Study of Dioxins and Furans in Adipose Tissue:
The VA, in cooperation with the Environmental Protection Agency
(EPA), i« performing a very detailed analysis of tissue
specimens from approximately 200 males of th© Vietnam era ag©
group. Th© specimens are analyzed for 2,3,7,8-TCDD and several
other related dioxins and furans to determine if service in the
military, especially service in Vietnam has resulted in
increased levels of these compounds as compared to non-Vietnam
veterans or civilians of the same age group. The final report
for this study, which began in October 1983 is targeted for
December 1987.
Prospective Study of Dioxins and Furans in Adipose Tissue:
A recent study estimated the half-life of dioxin in adipose
tissue to bo 5-3 years. Therefore, among Army Vietnam
veterans,dioxin in adipose tissue may still reflect exposure to
Agent Orange during the Vietnam war. Prospective collection of
adipose tissue specimens based on prescribed protocol will
afford bettor control of factors that may influence the final
outcome than retrospective specimen collection. This study will
strengthen the retrospective study results and help to clarify
the relationship between dioxin levels in the body and the risk
of developing medical problems.

�Soft Tisaue Sarcoma Study:
In vic&gt;w of the concerns raised by many veterans and conflicting
findings in tha scientific literature, an independent
epidsroiologic study was undertaken to determine r.he relationship
of Vietnam service, probable Agent Orange exposure and other
factors to the risk of developing STS. Thia study began in
March 1983 and the final report was completed in December 1986.
Cohort Mortality Study of Marine Vietnam Veterans;
The CDC Epidemiology Study of Vietnam veterans includes only
Army veterans in the study. The VVMS results suggest a possible
difference in mortality patterns between Army veterans and
Marine veterans. This proposed study will determine the overall
mortality rate as well as cause specific mortality rats® of
Marine* veterans who served in Vietnam and those who served
elsewhere. This study is designed to complement the CDC study.
Women Vietnam Veterans Mortality Study:
None of the studies that were already completed or on-going is
specifically designed to study women Vietnam veterans. This
cohort study will assess mortality experience of women veterans
who served in Vietnam compared to thosa women veteran© who
served eluewhere during tha Vietnam war.

Women Vietnam Vet«rana Health Study:
Public kaw 99-272 mandates the* conduct of an epidamiologic study
of any long-term adverse health effects {particularly
gender-specific health effects) which have been experienced by
women who served in the Armed Forces of the U.S. in the Republic
of Vietnam during the Vietnam ara. These include health affects
which may have resulted from traumatic experiences during
Vietnam service, or from exposure to phenoxy herbicides
(including Agent Orange), othesr herbicides, chemicals,
medications, environmental hazards, or from any other experience
or exposure during such service. This study will assist in
determining appropriate treatment of condition®, if any,
possibly related to that experience. The contract, for protocol
development waa awarded to the New England Research Institute in
October 1986, with anticipated completion of protocol
development in July 1987. The target date for awarding a
contract for the conduct of tha study is December 1987.
Case Control Study of Non-Hodgkin's Lymphoma:
Several epidemiologic studies suggested that individuals exposed
to phonoxyherbici'Ses had a substantial increase in risk of
non-Hodgkin'a lymphoma (NHL). A case control study is planned
to investigate the possible association between NHL and Vietnam
service, Agent Orange exposure or other possible environmental
risk factors.

�Health Surveillance of Vietnam Era Veterans:
The existing VA records, such as the Pstiont Treatment File
(FTP) and Agent Grange Registry, will be monitored periodically
to duterrain® whether there are any unusual pattern© or trends
that way indicate a need for an in-d«pth review.

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Author
Corporate Author
RBpOrt/ArtlClB Title Typescript: Dioxin Discussion Meeting - Veterans
Administration, September 1,1983

Journal/Book Title
Year

000

°

Month/Day
Color

n

Number of Images

15

DOSCriptOn NOtOS

Includes meeting agenda, list of participants and a
phtocopy of Michele Flicker's handwritten notes from
the meeting.

Wednesday, June 06, 2001

Page 1657 of 1688

�DIOXIN DISCUSSION MEETING - VETERANS ADMINISTRATION
Import-Export Building - Room 443
811 Vermont
Washington, D.C.
September 1, 1983

AGENDA
9:30 AM - J. S. Stanley - Opening Remarks, "Status of Adipose Tissue
Analysis Programs"
9:45

- A. L. Young, "Status of VA/EPA Efforts in Adipose Tissue
Programs"

10:00

- D. Stalling, "Applications of Pattern Recognition for Classification of PCDD/PCDF Data"

10:30

- J. McKinney, "Approaches to Bioincurred TCDD Studies"

11:00

- T. Tiernan, M. Taylor, "Interferences Encountered in the Analysis of Human Adipose Tissues"

11:30

- D. Cox, "Status of Survey Design Using NHMP Adipose Samples"

12:00 PM - Open Discussion

�ADIPOSE MEETING

September 1, 1983

Washington, DC

F. W. Kutz

(202) 389-5534

Washington, DC

VA

Alvin L. Young

(202) 382-3569

Joe Carra

EPA

Washington, DC

(202) 382-3886

Ganga Choudhary

NIOSH

Cincinnati, OH

(513) 684-4217

Larry Keith

Radian

Austin, TX

(512) 454-4797

Don Grant

HPB

Ohawa, COT

(613) 996-3833

Arnold Schecter

Upstate Medical Center - Clinical Campus
S.U.N.Y. Binghamton, NY 13901

J. J. Ryan
Roy Noble

HPB

Ohawa, ONT

Monsanto Research Corp.

Lewis Shadoff
Christoffer Rappe

(607) 798-4809
(607) 772-6067

Dow Chemical Co.
Univ. Umea

(613) 593-4482

Dayton, OH

(513) 268-3411

Midland, MI

(517) 636-5584

S-90187 Umea Sweden

(46) 90-165266

Jim McKinney

NIEHS

RIP, NC

(919) 541-3253

David Firestone

FDA

Washington, DC

(202) 245-1381

David L. Stalling

USFWS

Ross Norstrora
Michele Flicker

John Gierthy

Columbia Nat. Testing Res.
Lab. - Rte. 1 Columbia, MO
65101

Com. Wildlife, Sch
VA

NYS Dept. of Health

(FTS) 276-6399

Environmental Canada, (613) 997-1410
Ottowa
Kansas City, MO

(FTS) 754-1674
(816) 861-4700
ext. 674

Albany, NY

(518) 473-3851
(FTS) 236-4176

Bob Hill

CDC

Atlanta, GA

(404) 452-4176

Larry Bayse

CDC

Atlanta, GA

236-4151

�Les Lamparski

Dow Chemical

Midland, MI

(517) 835-6600

David Cox

Battelle

Washington, DC

(202) 785-8400

Jean Futrell

Univ. of Utah

Salt Lake City, UT

(801) 581-7307

John Going
*?Q\w S^A^Yt

MRI

Kansas City, MO

(816) 753-7600

David Redford

EPA

Washington, DC

(202) 755-2926

Mike Taylor

Wright State Univ.

Dayton, OH

(5.13) 873-2202

Pat O'Keefe

NYS Health Dept.

Albany, NY

(518) 473-3373

T.J. Nestrick

Dow Chemical

Midland, MI

(517) 636-6207

N.C.A. Weerasinghe ' Univ. Nebraska

Lincoln, NE

(402) 472-3507

Bob Heath

EPA

Washington, DC

(202) 382-3901

Joe Breen

EPA

Washington, DC

(202) 382-3569

Mary Frankenberry

EPA

Washington, DC

(202) 382-3890

Washington, DC

(202) 382-3854

Washington, DC

(202) 382-3582

Sandra Strassman-Sundy
Daniel T. Heggem
William Dunn

EPA

EPA

Univ. of 111. at Chicago Chicago, IL
College of Pharmacy
833 South Wood, Chicago, IL 60680

(312) 996-5232

�v2* Veterans Administration

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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>Typescript: Dioxin Discussion Meeting - Veterans Administration, September 1, 1983</text>
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                    <text>Item ID Number

01657

Author

Lawson, Neal C.

Corporate Author
Report/Article TltlO Memorandum: Proposed Confidentiality Measures for
an Environmental Protection Agency (EPA)
Pesticide/Fat Bank Study on Accident Victims, from
Neal C. Lawson to Special Assistant to the General
Counsel, January 9,1984

Journal/Book Title
Year

oooo

Month/Day
Color
Number of Images

D

4

Descripton Notes

Wednesday, June 06, 2001

Page 1658 of 1688

�Veterans
Administration

\m 9 w

Dalo:

Special Assistant to the General Counsel
Assistant General Counsel

(02C)

(024)

Proposed Confidentiality Measures for an Environmental Protection Agency (EPA) Pesticide/Fat Bank Study on Accident Victims
1. At your request, we have reviewed the attached proposal
dated September 6, 1983, concerning the protection of data
generated in the subject study drafted by an EPA contractor.
2, It is our understanding that the parties involved in this
study, i.e., the EPA, its contractor, and the Veterans Administration, desire to maintain/ as far as possible, the confidentiality of medical records and other data used in this study,
which is in the nature of a feasibility phase of a possible
larger study to be funded by the interagency work group on Agent
Orange. To maintain confidentiality of the medical records and
other data, the contractor's proposal outlines the following
suggested steps to be taken to reach that objective.
.3. Essentially, autopsy or pathological reports of the accident
victims are to be sent to the EPA from the various patholo.g.'ists
who generated those ,.records. Immediately upon receipt, the EPA,
acting only as a conduit, is to forward these reports to its
contractor for preparation of a confidential identification
roster that w i l l be used by the contractor only. To be included
in this roster, with VA involvement, is "study group assignment"
information indicating the accident victims' military status,
i.e., nonmilitary service, military service/Vietnam, and
military servi.ee/rion~Vietnam. The VA will provide the EPA with
that information once it matches victims' social security
numbers received from the EPA with VA veterans and beneficiaries
identification and records location subsystem (BIRLS) information. However/ neither the VA nor the EPA will retain a. copy of
that information, but will forward it to the EPA contractor for
inclusion in the roster and for annotation of the medical
records. At the conclusion of the study, the medical records
would be transferred to the EPA, but disposition of the contractor's confidential indentif ication roster is subject to one
of three proposed options: (1) the contractor destroys the
roster, precluding any further VA or EPA follow-up; (2) the
contractor maintains the roster; or (3) the contractor turns
over the roster to the EPA.

•./ A I
M A Y

�2.
Special Assistant to the General Counsel

(02C)

4. Prom the viewpoint of the VA, it is our opinion that once
the VA receives social security numbers of accident victims from
the EPA that information, as well as the later included study
group assignments, must be considered to be Agency records and,
thus, subject to the provisions of the Freedom of Information
Act (POIA), S U.S.C. ') VV2. As such, that information must be
released, so long as it remains in the custody of the Agency, to
a FOIA requester subject to any applicable deletions permitted
under one or more of the subsection (b) exemptions. In this
regard, we note that, generally, the victims' social security
numbers could be withheld from virtually all POIA requesters
under the (b)(6) exemption of the FOIA as a clearly unwarranted
invasion of personal privacy. However, once that individually
identifiable information is deleted, the remaining study group
assignment information would have to be disclosed. Since we
assume all the information is factual the (b)(5) (i.e.,
deliberative process privilege) exemption would not be available
for use by the VA, Nevertheless, once that information. .-leaves
the control of the Agency (see., Cor example,
.
'
_
.
- 445 U.S. '136 (1980)) a n d remains i n t h e
custody and control of the contractor, it is protected in its
entirety from disclosure under the POIA (see F or s ham v . jja cr_ i s ,
_
445 U.S'. 169 (1980)) .
5. Considering confidentiality of the records from the
perspective of the Privacy Act of 1974 (5 U.S.C. § 552a) , we
note that the Privacy Act applies to information maintained by
the VA, the EPA or their contractors (under subsection (m) ,of
the Act) and retrievable by individual identifiers of living
individuals who are the subjects of the records. Assuming that
the information in question will be maintained in a Privacy Act
system of records, it is subject to access by the individuals
involved (5 U.S.C. § 552a(d)) with even the contractor mandated
to allow such access.
6. With respect to confidentiality of the contractor's confidential identification roster upon the conclusion of the study,
we note that Option c3o. 1 affords the best confidentiality
protection; Option No. 2 maintains the confidentiality of: the
roster until a suit requires disclosure under discovery or a
court order but would constitute a violation of the Privacy Act
if the contractor maintained these individually identifiable
records and they were no longer relevant to a purpose of the EPA
(5 U.S.C. § 552a(e)(l)); and Option No. 3 provides the least
degree of confidentiality with the EPA taking responsibility for
confidentiality. Since Option No. 1 would preclude any later

�3.

Special Assistant to the General Counsel

(02C)

VA use of the roster information, we believe that option should
not be encouraged despite its excellent confidentiality
protection. Thus, it appears that Option No. 3 may be the only
viable option for VA purposes,
7. Finally, we note in passing that should the Agency receive a
FOIA request for the subject study materials, the VA would not
be able to "hide oehind" the inscription contained in the•'contractor's "Attachment 0."

NEAL .C. LAWSON
Attachment

�VA COHORT STUDY CONFIDENTIALITY

Attachment B
J2JLJ-0/
It appears that the nature of this phase of proposed work will preclude
its accessibility to outside firms under a Freedom of Information Act (FOIA)
requests This phase of the VA Cohort Study is in the nature of a feasibility
study for a larger, full-scale study potentially to be funded by the Interagency Workgroup on Agent Orange. A possible FOIA exclusion, therefore,
would lie in the fact that the proposed phase of work concerns predecisional,
opinion of draft materials developed by the Government. In addition, it is
possible that this information is considered personal and medical,
the disclosure of which could constitute an invasion of privacy. It is
suggested that all deliverable^ containing confidential information (patient
medical information or patient identifying information) that JRB produces
include the following inscription on the cover page:
"Predecisional Draft: This report (material) contains
predecisional information for administrative consideration
by the EPA and the VA, For internal circulation only; not
for quotation or citation."
These are suggestions as to possible interpretations under FOIA exclusions
and arc not meant to be conclusions of law as JRB is not a professional corporation licensed to practice law. These suggestions should be reviewed by the
EPA General Counsel and, if accepted, might effectively exclude VA Cohort
Study .materials and deliverables from the Freedom of Information requests,

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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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Young, Alvin L.

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RepOrt/ArtldO TltlO Manuscript: Young's notes on "Veteran Issue: Chemical
Exposure in Vietnam vs Dioxin Issue: Vietnam, New
York, Missouri, New Jersey and Michigan, January 13,
1984

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000

°

Month/Day
Color

O

Number of Imauoe

1

Dascripton Notes

Wednesday, June 06, 2001

Page 1662 of 1688

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01 ees
Stockmoe, Larry R.

CorpuratuAuthnr
Memorandum for the Record: EPA/VA Meeting,
February 2,1984, "Retrospective Study of Dioxins and
Furnans in Adipose Tissue," February 3, 1984

Journal/Book Title
Year

000

°

Month/Day
Color

^

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1

DOSCrlptOU Notes

Discusses EPA funding of study phases and AOWG's
comments on study.

Wednesday, June 06, 2001

Page 1666 of 1688

�MEMO FOR RECORD

SUBJECT: EPA/VA Meeting, February 2, 1984, "Retrospective Study of Dioxins and
-j

Furnans in Adipose Tissue".
ATTENDEES: VA- Dr. Barclay M. Shepard, Dr. Han K. Kang, Mr. Larry R. Stockmoe
EPA- Dr. Donald Barnes, Dr. Mike Dellarco, Mr. Mike Cook
Other-? Dr. Alvin Young, Senior Policy Analyst for Life Sciences,
Office of Science and Technology Policy, Executive Office
of i .the President
CONCLUSIONS OF MEETING:

1. EPA will be unable to provide funding for Phases II and III work.
2. The study protocol should be submitted to the AOWG's Scientific
Subconnittee for review and any recommendations they care to make.
3. The ACWS's comments will be considered including a host of options such
as limiting the tissue analysis to 2,3,7,8-TCDD, having one or two
laboratories conduct the tissue analysis, requesting other agencies to
join us and contribute to the project, etc.
4. Dr. Barnes will have a status report provided to Dr. Shepard as regards
Phase I activities and finances.
5. The VA needs one signed original copy of Amendment Number 3, IGA V101
(91) P-82016 (EPA Number AR36F3A439) for the additional $96,000 necessary
for EPA to conclude Phase I. Following this, the VA may authorize the
transfer of funds upon receipt of EPA's SF 1081 (Voucher and Schedule
of Withdrawals and Credits).
6. Dr. Barnes and Dr. Kutz will continue to be the VA's contacts for the
project.

- -~/x

Larry R. Stockmoe
Administrative Officer
Research Section, Agent Orange Projects Office
Department of Medicine and Surgery
VA Central Office

cc; Dr. Donald Barnes

Dr. Han Kang

�</text>
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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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Author

°1666
Kan

9'Han K-

Corporate Author
Report/Article Title Typscript: Retrospective Study of 2,3,7,8-TCDD in
Human Adipose Tissue, February 15, 1984

Journal/Book Title
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a

3

Doscrlpton Notes

Wednesday, June 06, 2001

Page 1667 of 1688

�FEB 1 5 1984
Retrospective Study of 2,3,7,8-TCDD
in Human Adipose Tissue

Objectives
1. To develop a reliable, precise and sensitive analytical method for the
determination of 2,3,7,8-tetrachlorodibenzo-p-dixoin (2,3,7,8-TCDD) and
other dioxins and furans in human adipose tissue.
2. 1b estimate background levels of 2,3,7,8-TCDD in the fate-of the
American adult male population.
3. To determine whether the dioxin body burden of Vietnam veterans is
different from that of other Vietnam era veterans and the general
population.
Sour ce of Adipose Tissue
Under the National Human Adipose Tissue Survey (NHATS) the Environmental
Protection Agency (EPA) has been monitoring the concentrations of various
pesticides in the adipose tissue collected from a broad segment of the
U.S. general population. The Veterans Adiministration (VA) has identified
the archived adipose tissue specimens from the NHATS as a source of
adipose tissue. Represented within the archived tissues are approximately
550 males born between 1937 and 1952, i.e., the birth date window of men
who potentially served in Vietnam.
Status of Study
Under an interagency agreement (IAG V101 (91) P-82016, EPA No. AR 36 F3A
439) EPA is to collaborate with VA in the following phases:
1. Assess the status of archived adipose tissue and develop a survey
design. Obtain Social Security number and autopsy or surgical report
for each of the 550 males.
2. Develop a collaborative validated method to analyze for
2,3,7,8-TCDD in humans. The method is to be subjected to rigorous
laboratory validation by an independent analytical referee, e.g., the
Association of Official Analytical Chemists (AOAC).

�3. Develop a rigorous quality assurance progran to assure the
quality of the analytical procedures and results.
To date:
1. rJfae 550 adipose tissue specimens slated to be used for the study
have been identified and moved from the EE&amp; Toxicant Analyses Center,
Bay St. Louis, Mississippi to the Midwest Research Institute, Kansas
City, Kansas.
2. A total of 397 pathology reports and 268 Social Security numbers
have been obtained for these 550 deceased individuals.
3. Ihe published literature on dioxin analyses for biological
matrices has been critically reviewed and a consensus has been
reached by experts on an analytical method to be validated by intra
and inter- laboratory tests.
Problems
1. EPA could not come up with the necessary matching funds and
personnel to continue the study.
2. VA has only enough funds to complete the development of analytical
method for TCDD in adipose tissue.
3. No funds are currently available for interlaboratory validation of the
analytical method and actual analysis of TCDD in 550 archived adipose
tissues.
Options
1. We can use an existing analytical method with a minimum attempt for
interlaboratory validation and complete the analysis of the 550 adipose
tissue specimens.
Pro: We may be able to obtain data on 2,3,7,8-TCDD levels in the
adipose tissue specimens without a substantial increase in funds.
Con: There is room for criticism for not using an analytical method
which is validated by an independent analytical referee.
2. We can present Option 1 to the Science Panel, AOWG and proceed only
when the panel approves the approach.
Pro: The study results will be less likely to be questioned.
Con: If we cannot obtain a blessing from the panel the entire
project is stalled.

�3. We can present the problems to the Chief Medical Director (CMD) and
request resources to complete the study as originally conceived.
NOTE: I believe in light of the CDC's independent effort to develop an
analytical method for dioxin in blood and EPA's reluctance to support the
study it is not realistic to anticipate financial support from other
agencies via AOW3.

I recommend you seriously consider Option 1. We requested a total of
$300,000 (200K, FY 1985; 100k, FY 1986) for a prospective study of dioxin
in human adipose tissue. ' If all or some of this amount is -approved we can
use the funds to support a limited inter and intralaboratory validation
for the present project.

HAN K. KANG, Dr.P.H.
Chief, Research Section
Agent Orange Projects Office

�</text>
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°1667

Author

Brandt, Edward N.

Corporate Author
Report/Article TltlB Memorandum: Fat Biopsy Study, from Edward N.
Brandt to Donald Barnes and Barclay Shepard, March
16,1984

Journal/Book Title
Year

000

°

Month/Day
Color

IJ

Number of Images

1

Descripton Notes

Wednesday, June 06, 2001

Page 1668 of 1688

�-fc

4

DEPARTMENT (&gt;! HEALTH &amp; HUMAN SERVICES

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Public Health Service

Office of the Assistant Secretary
for Health
Washington DC 20201

MEMORANDUM
FROM

:

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f,vy , ,
Chair pro tempore,
Cabinet Council Agent
Orange Working Group

SUBJECT:

Fat Biopsy Study

TO

Dr. Donald Barnes
Environmental Protection Agency

:

Dr. Barclay Shepard
Veterans Administration
I would appreciate your getting together with Dr. Carl Keller,
Chairman of the Science Panel, for the purpose of developing a
specific protocol for the fat biopsy study.
Please keep me informed as to your progress.

Edward N. Brandt, Jr., M.D,

GENT ORANGE
MAR 10 '^54

RECEIVED - (IOA7)

S
^

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