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01739

Author

Custis, Donald L.

Corporate Author
Report/Article TltlO Memorandum: Research Instrumentation, from Donald
L. Custis to Directors of VA Medical Centers, March 13,
1979

Journal/Book Title
Year

000

°

Month/Day
Color

n

Number of Images

3

UOSCrlptOU NOtBS

Alvin L Youn

Monday, June 11, 2001

9filed this item under "Vietnam Veterans
Twin Study."

Page 1790 of 1793

�Veterans Administration
Department of Medicine and Surgery
Washington, D.C. 20420

CIRCULAR 10-79-48
. ,- .*•,*
m
'

To : Directors, ^ Medical Centers, Domiciliary, Outpatient Clinics,
Medical and Regional Office Centers and Regional Offices with
Outpatient Clinics (151)
SUBJ: Research Instrumentation
1. Current fiscal constraints require that there be careful review of any
request for research equipnent, whether it is submitted as part of a merit
review application, a request to the Research Advisory Groups, or through
any other review mechanism. Research and Development Letter, IL 15-75-2,
issued in March 1975, was developed to establish guidelines for information which would facilitate review of equipnent requests. The purpose of
this Circular is to reinforce those guidelines, and to describe the type
of equipment control which should be assured at all health care facilities.
2. Acquisition of Additional or Replacement Equipment. All requests for
equipnent which exceed a total of $5,000 or cost $2,000 or more per
individual item will include the following information as far as
applicable to each item requested:
a. Names and projects of all investigators who will use this
equipnent.
b. Ihe approximate hours per week the equipnent will be used by each
investigator.
c. Detailed description of chosen instrument; technical
specifications as provided by the manufacturers; identification
of other similar equipnent which had been considered; and,
reasons the requested instrument is preferred.
d. List of all presently available equipnent at your facility which
can perform the same function (as it is, or with an accessory) as
that now requested; reasons why an additional instrument is
required. Include a copy of the usage log of the available
instrument in question.
e. If requested equipment will be used in conjunction with other
available instruments or any parts of them, identify these
instruments, their function, and the interface of the various
parts.
f. Additional information appropriate to the particular request,
including information about local factors, such as availability
of service for upkeep of a complex piece of equipnent. Without

A /9f/ ,
CIRCULAR EXPIRES MARCH lA/ 1Q80-

�CIRCULAR 10-79-48
March 13, 1979

this information, a request cannot be acted upon favorably. For
merit review proposals, this information should be submitted as
an addendum.
3. Equipment Utilization. Review and documentation of equipment
utilization at each health care facility should be sufficient to assure
that all available equipment is being optimally utilized. At the time of
the annual inventory of research equipment and the signing of the
Consolidated Memorandum Receipt (CMR), a systematic review will be
undertaken to determine utilization, potential for sharing, or the need
for disposal (MP-2, Subchapter E, Sec. 108-27.5302-3(c)).
4. Disposal of Equipment. Equipment which is not being utilized to an
extent which continues to justify its retention should be made available
for transfer to another health care facility through the Central Research
Instrument Program (CRIP). In order to encourage increased use of CRIP by
health care facilities, the following actions will be taken:
a. Any health care facility which turns in to CRIP a non-utilized
equipment item that is subsequently transferred in good condition and utilized in another VA research program will receive
from VACO undesignated non-recurring Program 821 funds.
b. ftiese funds will equal one-half the estimated value established
by CRIP for each piece of equipment. This amount will be
obtained only if the equipnent is in good working condition when
received. Vihere repairs are required, the cost will be
subtracted from this amount. Funds will be transferred to the
health care facility that has turned in the equipment after the
equipnent has been received and placed into use at another V&amp;
health care facility.
c. Health care facilities which turn in surplus equipment to CRIP
will receive priority consideration when they subsequently
request equipment from CRIP.
d. 1b assure that equipment is not danaged or lost en route to the
receiving facility, instructions for packing equipment will be
made available by CRIP to donor health care facilities.
5. Responsibilities of the Research and Development Committee. The
Research and Development Committee should assure that all equipnent
requests are fully justified and documented. The committee will determine whether the equipment requested, or a suitable alternative, is available, or can be made available, and should consider alternate equipnent
which might be used more economically. The committee will periodically

�CIRCULAR 10-79-48
March 13, 1979

review all equipment utilization in the research program to identify and
determine the best disposition of underutilized equipment.
6. Research Equipment Subcommittee. Health care facilities with large or
complex research programs may establish a Research Equipaent {subcommittee
to advise the Research and Development Committee on these matters. The
membership of the committee should include a biomedical engineer, if
available to the facility, a basic scientist, the Administrative Assistant
to the Associate Chief of Staff (ACOS) for Research and Development, and
one or more investigators having a broad knowledge of research
instrumentation.
7. Responsibilities of the Associate Chief of Staff for Research and
Development.Whether the Research and Development Committee assumes
primary responsibility for equipment review itself, or delegates this
review to a subcommittee, the equipment program will be coordinated with
the ACOS for Research and Development, who is responsible for its
administration. The subcommittee should be certain that appropriate
technical and scientific expertise is available for proper administration
of the equipment program.
8. Any questions regarding the procedures for implementing this policy
may be referred to :
James 0. Wear, Ph.D., (151B)
Chief, Central Research Instrument Program
Veterans Administration Medical Center
North Little Itock Hospital Division
Little Rock, Arkansas 72206
PTS 740-1525

kV/\ o i
DONALD L. CUSTIS, M.D.
Deputy Chief Medical Director
Distribution:
SS (101B1)

S89990.P

COB: ( 0 only plus (151C) 15
1)
FSB: HA, DO, OC, OCRO
EX: Box 66-6, Boxes 61, 71, 76-1 ea. and 77-5 ea.

�</text>
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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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          <elementTextContainer>
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          </element>
          <element elementId="49">
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            <elementTextContainer>
              <elementText elementTextId="22787">
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              </elementText>
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  </item>
  <item itemId="3111" public="1" featured="0">
    <fileContainer>
      <file fileId="1609">
        <src>https://www.nal.usda.gov/exhibits/speccoll/files/original/0b7c6197e822b27a64b9a912dc7937e8.pdf</src>
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                    <text>Item ID Number

01788

Author

Custis, Donald L.

Corporate Author
Roport/Artldo TitlO Memorandum: DHEW Required Information About
Compensation and Treatment of Injured Clinical
Research Participants, from Donald L. Custis to
Directors of VA Medical Centers, December 29, 1978

Journal/Book Title
Year

000

°

Month/Day
Color

n

Number of Images

2

DOSCTlptOn NOtOS

Alvin L

- Young filed this item under "Vietnam Veterans
Twin Study."

Monday, June 11, 2001

Page 1789 of 1793

�CIRCULAR 10-78-300
December 29, 1978
TELEGRAPHIC MESSAGE
NAME OF AGENCY

SECURITY CLASSIFICATION

PRECEDENCE

VACO WASHINGTON, DC

ACTION:

P

INFO:

ACCOUNTING CLASSIFICATION

TYPE OF MESSAGE

DATE PREPARED
12/29/78

[3 SINGlf

FOR INFORMATION CAU
NAME

fifttOOK

PHONE NUMKR

DR. HOBSON

MUITIPIE-ADORESS

389- 2616

THIS SPACE FOK USE OF COMMUNICATION

UNIT

MESSAGE TO BE TRANSMITTED (UuJmUt ipadiig «»&lt;/«// tafilal ItlUn I

TO:
I

DIRECTORS OF VETERANS ADMINISTRATION MEDICAL CENTERS,
MEDICAL AND REGIONAL OFFICE CENTERS, DOMICILIARY,
OUTPATIENT CLINICS, AND REGIONAL OFFICES WITH OUTPATIENT CLINICS

00/15

CIRCULAR 10-78-300 SUBJ:

DHEW REQUIRED INFORMATION ABOUT

COMPENSATION AND TREATMENT OF INJURED CLINICAL RESEARCH PARTICIPANTS
(43 FR 51559).

1.

AFTER 1/2/79, PROJECTS SUPPORTED BY RESEARCH FUNDS FROM DHEW MUST

PROVIDE THAT PROSPECTIVE PARTICIPANTS IN CLINICAL, BIOMEDICAL OR
BEHAVIORAL RESEARCH BE INFORMED AS TO COMPENSATION AND MEDICAL TREATMENT AVAILABLE IF THEY SUSTAIN PHYSICAL INJURY.
2.

IN OBTAINING INFORMED CONSENT, VA INVESTIGATORS MUST SPECIFICALLY

INFORM PARTICIPANTS OF THEIR RIGHT TO COMPENSATION AND TREATMENT FOR
PHYSICAL INJURY IF THE RESEARCH PROTOCOL IS APPROVED AFTER 1/2/79.
INVESTIGATORS MUST GIVE THE REQUIRED INFORMATION IN CONFORMITY WITH
FEDERAL LAWS, AND MUST FOLLOW THE CONTENTS OF THIS MEMORANDUM.
3.

INVESTIGATORS WILL BE REQUIRED TO PROVIDE DIFFERENT INFORMATION

TO VETERANS ELIGIBLE FOR MEDICAL CARE ON THE ONE HAND AND TO NONELIGIBLE VETERANS AND NON-VETERANS ON THE OTHER.

FOR EXAMPLE,
SECURITY CLASSIFICATION

PAGE NO

ItANOAlO IO«M 14
REVISED AUGUST l»67

GPO : 1973 — 495-8S7

NO

OF PCS

�TELEGRAPHIC MESSAGE
putcEDENa

NAMC Of AGENCY

ACTION:

SECURITY ClASSIFICATION

P

INFO;

ACCOUNTING CLASSIFICATION

TYPE Of MESSAGE

DATE PMPA«ED

12/29/78
Q] SINGLE

FOR INFORMATION CAll
NAME

Q IOOK

PHONE NUMIEft

Q MUITIPIE-ADO«ESS

DR. HOBSON
THIS SPACE f-OK

389-2616

L'St Oh COMMUNICATION UNIT

MESSAGE TO BE TRANSMITTED (Uu Jouhlt i/ucixg «»&lt;/«// fapilat Itlltnf

TO:

ELIGIBLE VETERANS ARE ENTITLED TO MEDICAL CARE AND TREATMENT FOR
ANY INJURY SUSTAINED.

COMPENSATION MAY ALSO BE PAYABLE UNDER

38 USC 351 OR, IN SOME CIRCUMSTANCES, UNDER THE FEDERAL TORT CLAIMS
ACT.
4.

NON-ELIGIBLE VETERANS AND NON-VETERANS ARE ENTITLED TO MEDICAL

CARE AND TREATMENT ON A HUMANITARIAN EMERGENCY BASIS WITH THE MEDICAL
CARE APPROPRIATION REIMBURSED FROM RESEARCH FUNDS.

ANY COMPENSATION

FOR THEM, HOWEVER, WOULD BE LIMITED TO SITUATIONS WHERE NEGLIGENCE
OCCURRED AND WOULD BE CONTROLLED BY THE PROVISIONS OF THE FEDERAL
TORT CLAIMS ACT.
5.

IT IS SUGGESTED THAT QUESTIONS IN SPECIFIC INSTANCES BE REFERRED^

TO YOUR DISTRICT COUNSEL.

THIS CIRCULAR EXPIRES

15/10A

DONALD L. CUSTIS, M.D.
DEPUTY CHIEF MEDICAL DIRECTOR —
r

DISTRIBUTION:

SS (101BI)
STAMDAID FORM 14
REVISED AUGUS' l»«7
OS* FPMH &lt;t\ Cf»&gt; im-1&lt; •

COB: ( 0 only plus (ISA) 15,
1 )
EX: Boxes I &amp; 7 - 4,
PAGE NO
Box 66 - 6, Boxes 71,
15
76 and 77 - 1 ea.
GPO : 1973 — 49S-«57

NO

OEC 2 •? 1978

SECUBITV CLASSIFICATION

Of PGS
587954.L

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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>Custis, Donald L.</text>
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                <text>Memorandum: DHEW Required Information About Compensation and Treatment of Injured Clinical Research Participants, from Donald L. Custis to Directors of VA Medical Centers, December 29, 1978</text>
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                <text>Vietnam Experience Twin Study</text>
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                <text>study protocol</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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The proposed effort would involve a jointly-funded program between the VA and EPA to
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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:

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Liver function; When animals are exposed to TCDD and related compounds,
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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
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Seven of the funded research studies will investigate the

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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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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
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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.

;

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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
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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;
&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: 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, Septe</text>
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