INTERAGENCY MEETING ON FEDERAL RESEARCH
INTO THE BIOLOGICAL EFFECTS OF IONIZING. RADIATION
National Institutes of Health
. Building 1, Room 114
Bethesda, Maryland 20205
Friday, March 2, 1979
1:30 to 3:00 P.M.

AGENDA

I. Introduction--Dr. Donald S. Fredrickson
II. Review of the Draft Charter--Meeting Participants
III. Review of Proposal. for Study by the NAS

e Survey of Current Government Studies--Dr. Robert S. Gordon,
Special Assistant to the Director, NIH

e Discussion by Participants

IV. Conclusion--Dr. Fredrickson

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MEETING OF INTERAGENCY REPRESENTATIVES
CONCERNED WITH THE BIOLOGICAL EFFECTS
OF IONIZING RADIATION

Minutes of the First Meeting
March 2, 1979

The first interagency meeting on Federal research into the biological
effects of ionizing radiation was held Friday, March 2, 1979, at the
National Institutes of Health. Dr. Donald S. Fredrickson, NIH Director,
chaired the meeting, and Dr. Joseph G. Perpich, Associate Director for

Program Planning and Evaluation, served as executive secretary.

The purpose was to review certain mandates based on Congressional and
Presidential directives and given to Dr. Fredrickson by Secretary Califano.
Representatives had been recommended by Mr. Peter Libassi, General

Counsel for HEW, who chairs the Interagency Task Force on the Health
Effects of lonizing Radiation. Prior to the meeting, all representa-
tives were sent two documents : a draft charter for a proposed new
committee , The Interagency Committee on Federal Research Into the
Biological Effects of Ionizing Radiation, and a draft letter from

: r Fredrickson to the National Academy of Sciences (NAS) requesting

study of Federal programs.

pe_of the Conmittee’s Mandate
‘Fredrickson opened the meeting with a brief review of Congressional
| initiatives and then discussed the tentative charter for the

ittee. One of the first issues considered was the scope of research

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to be covered. It was noted that the proposed charter reads "biological
effects" rather than "human effects," raising a question of emphasis.
Would the Committee cover both human and animal studies, including
animal husbandry and the like? Dr. Fredrickson said the emphasis would
be on human epidemiologic studies, but a wider range of biological
effects was to be encompassed. A number of Committee members agreed
that animal studies must be included, particularly in view of their
relevance to human effects, but the Committee would not have an interest
in animals per se. It was agreed that the scope of research as cited

in the charter would not be changed.

Another issue related to what standard would be used for determining
low-level ionizing radiation for purposes of the Committee's mandate.
Dr. McIndoe, DOD, asked whether the definition of "low-level" was less
than 5 rems per year. Dr. Mills, EPA, suggested that the limit not be
rigidly set, as much good information for purposes of the Committee's
task would be excluded. After some discussion, tt was agreed that while
reference points would be needed later, there should be initial agree-
ment on goals rather than tasks and no limit set yet on the level of
jonizing radiation to be investigated. Dr. Upton, NCI, pointed out that
the primary focus of the Committee will be to look at radiation from
particular sources, occupational and environmental, and that the

objective will be a better understanding of low-dose exposure.

[652]
Discussion of Committee Charter

Representatives then turned to the statement of function in the charter.
The statement focuses on the need for a research strategy and priorities,
as well as for selecting the loci where the research should be conducted.
Several questions were raised about the term "select appropriate loci

and recommend allocation of resources. . . ." One person asked whether

it was envisioned that the Committee would have authority to conduct

“research programs or whether it was solely advisory. Or. Fredrickson

emphasized that it would be advisory.

In response to the question whether the Committee would review the
infrastructure of agencies to determine which laboratories should be
doing which work, Dr. Fredrickson said the Committee would Took generally
rather than deeply into agency structures, and would assist in the
coordination of research. in various program areas. Coordination (meaning
information exchange and a search for agreement on goals, strategies, and
specific approaches) was to be stressed, but there was need for some
agencies to take the lead in the allocation of efforts. After further
discussion, it was generally agreed that the phrase “select appropriate
loci" would be changed to “identify appropriate loci" as more consistent

with an advisory committee.

Another question concerned the clause "By the authority of the Secretary,

   
  

a Agencies are required to consult with the Committee.

pr. Fredrickson explained that the charter had been written for an HEW

- ather than an interagency committee. It was agreed that the ultimate

hority for a Federal committee would be the President. It was also

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suggested that the clause "all Agencies are required to consult: with
the Committee" be changed to “all Agencies agree to consult with the
Committee." Dr. Fredrickson concurred, believing the Committee must try

to act by consensus as much as possible.

Questions were raised concerning the Committee's role in reviewing

projects while a research strategy is being developed over the next year
and a half. Dr. Dickson, OASH, noted that if the Committee is to

review and approve proposals, there must be some strategy in mind, yet

it is planned to take over a year to build one. Dr. Fredrickson agreed
that the problem exists, but believes that the Committee must be monitoring

studies while the strategy is under review.

Further discussion centered on the possible options for achieving
coordination of Federal programs--from merely providing agency
consultation to requiring formal Committee review and approval of all
agency-proposed studies. Dr. Liverman, DOE, asked whether the Committee
is going to ensure that all useful information from past studies

will be used. Dr. Silverman, FDA, expressed concern about adding yet
another layer of approval required in the Government before epidemiologic
studies can be done, and pointed to the long delays in launching research
now. Dr. Fredrickson noted in response that we were not to try to

create a direct supervisory role. He suggested the intermediary option
that agencies agree to consult with the Committee and take its comments
into account. There was approval of that as part of the Committee's

mandate.

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Dr. McIndoe, DOE, asked where the comments of the Committee would go--
whether they would have an effect. Will the Committee address the
question of budgets, for example? In response, Dr. Fredrickson noted
that the comments would go to the individual agency involved. It should
be assumed that the Committee's comments might also go to the President--
presumably to the OMB--and the Congress. Thus agency budgets could be
affected indirectly but the Committee certainly wouldn't be expected to
develop a Federal budget for research in the subject area, or otherwise

to override individual mission responsibilities.

In summary, Dr. Fredrickson noted that there appeared to be general
agreement with the mandate of the Committee as modified--that the Committee
should study proposals and comment on them to the agencies and to the
relevant Executive Branch officials to whom the Committee is advisory.

He noted also that in assuring a basis for confidence in research and
regulation in the radiation area, the Committee was dealing with a

problem that affected the public perceptions of all Federally supported

science.

Dr. Fredrickson asked if there were further comments on the Committee or

its mandate. Dr. Budnitz, NRC, commented that the charter needed a

preamble stating why we want to know about the biological effects of
ionizing radiation. It should take into account the many agencies
represented. In response, Dr. Fredrickson asked that the agency participants
send in brief statements to be incorporated into the preamble. Another
question was whether OSHA had been invited to the meeting; and Dr.

Fredrickson said it had not, that only agencies with research components

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had been invited to this meeting, but that OSHA's needs and concerns

should also be stated in the preamble.

NAS Studies

Dr. Fredrickson briefly reviewed the Congressional mandate for studies
of Federal research programs in radiation. Copies of the Congressional
material were distributed. The mandate to HEW is that all Federal
research programs in the subject area be reviewed and that a research

Strategy be developed.

Dr. Mills, EPA, asked how these efforts could be synchronized with the
NAS's ongoing study of the Department of Energy. Dr. Fredrickson noted
that he had met with President Handler and other NAS staff, who agree
that if we move expeditiously the NAS could incorporate the study of a1]
Federal research programs as part of its overall study of DOE research.
He noted that the thrust of the overall NAS study should be toward the

Scientific content of programs rather than toward their management.

In response to questions about the proposed research strategy to be
developed by the Federal Committee, Dr. Fredrickson said that the BEIR
III report, 1/ which the Academy will release shortly, and the UNSCEAR

report 2/ can serve as the basis for developing the proposed strategy,

T/ The third report of the Advisory Committee on the Biological Effects
of Ionizing Radiations, by the Division of Medical Sciences, National

Academy of Sciences-National Research Council.
2/ Sources and Effects of Ionizing Radiation, United Nations Scientific

Committee on the Effects of Atomic Radiation, 1977 report to the
General Assembly with annexes: United Nations, N.Y. (725 pp.).

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which could then be subjected to critique by the NAS. Or. Fredrickson
emphasized that the Committee rather than the Academy would be responsible
for developing the strategy, since the latter has only an advisory role.
It was asked whether research gaps should be addressed to enhance the
critique of the proposed Federal strategy, and Dr. Fredrickson agreed
that this would be an important task for both the Federal Committee and

the NAS.

Conclusion

Dr. Fredrickson introduced Robert Gordon, a Special Assistant, who
chairs an NIH Epidemiology Committee. Dr. Gordon is working with NCI
representatives to review all Federal epidemiologic studies and to
determine whether better information can be obtained for purposes of

the Federal Committee. He displayed two charts that categorize all the
current studies collated by the Science Work Group of the Interagency
Task Force. He requested the agencies’ cooperation in responding to a
questionnaire he would develop and send to them for their review, to get
more information on the studies. There was general agreement to partici-
pate in the survey, which would be limited to studies on human health

effects.

y. Fredrickson concluded the meeting by thanking all agency representa-

 
 
 
 

es for their participation and cooperation. He noted that another
ting would undoubtedly be called within a month, and asked any agencies

itemplating new studies to inform him and the other members of the

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interagency group, especially if the Study is a large epidemiologic one.

The meeting was adjourned at 3:05 p.m.

Respectfully submitted,

Geepn G. Perpich, M.D., J.D.

Associate Director for
Program Planning and Evaluation

National Institutes of Health
Bethesda, Maryland 20205

April 6, 1979

[658]
Interagency Meeting on Federal Research
Into the Biological Effects of Ionizing Radiation
List of Attendees
March 2, 1979

DEPARTMENT OF DEFENSE

Colonel USAF, MC Darrell W. MeIndoe
Director

Armed Forces Radiobiology Research
Institute

DEPARTMENT OF ENERGY

Dr. James L, Liverman
Deputy Assistant Secretary for
Environment

ENVIRONMENTAL PROTECTION AGENCY

Dr. William H. Ellett
Chief
Bioeffects Analysis Branch

NUCLEAR REGULATORY COMMISSION

Mr, Karl R. Goller
Director, Division of Siting,
Health and Safeguards Standards

Mr. Robert Purple
Assistant Director for Radiological
Health and Safeguards Standards

Mr. Saul Levine
Director
Office of Nuclear Regulatory Research

Dr. Robert J. Budnitz
Deputy Director
Office of Nuclear Regulatory Research

Dr. Shlomo Yaniv

Technical Assistant to the Director

Division of Safeguards and
Environmental Research

VETERANS ADMINISTRATION

Dr. Lawrence Hobson

Deputy Assistant Chief Medical
Director for Research and
Development |

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DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

OFFICE OF THE GENERAL COUNSEL

Ms. Linda F. Donaldson
Office of the General Counsel

OFFICE OF THE ASSISTANT SECRETARY
FOR HEALTH

Dr. James F. Dickson III
Senior Advisor
for Environmental Affairs, OASH

Dr. Harold Margulies
Special Assistant for
Environmental Health, OASH

OFFICE OF HEALTH RESEARCH
STATISTICS, AND TECHNOLOGY

National Center for Health Statistics

Dr. Paul E. Leaverton
Associate Director for Research
Office of Statistical Research

CENTER FOR DISEASE CONTROL

Dr. Glyn G. Caldwell
Bureau of Epidemiology

National Institute for Occupational

Safety and Health

Dr. John R. Froines
Deputy Director

[660]

FOOD AND DRUG ADMINISTRATION

Bureau of Radiologic. Health

Mr. John C. Villforth
Director, BRH

Dr. Charlotte Silverman
Deputy Director, BRH

NATIONAL INSTITUTES OF HEALTH

Office of the Director

Dr. Donald S. Fredrickson
Director

Dr. Robert Gordon
Special Assistant to the Director

Dr. Joseph G. Perpich
Associate Director for

Program Planning and Evaluation
National Cancer Institute

Dr. Arthur C. Upton
Director

National Institute of Environmental
Health Sciences

Dr. David P. Rall
Director