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DEPARTMENT

USA

WELFARE

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

PUBLIC HEALTH SERVICE

NATIONAL INSTITUTES OF HEALTH

BETHESDA, MARYLAND 20014

October 26, 1979

[Identical letters were sent to panelists invited to NIH on
March 10-11, 1980. See program on page 347 for names.]

Dear

The Secretary, HEW, is required by law (P.L. 95-622 as amplified by supporting statements in the Congressional Record, October 14, 1978) to develop a comprehensive strategy for research into the biological effects of ionizing radiation supported or conducted by the Federal government. This strategy must reflect not only the needs of agencies with mandates to develop new knowledge, but also that research required by regulatory agencies to meet their responsibilities for protecting the public health. The Secretary has delegated this responsibility to Dr. Donald S. Fredrickson, Director of the National Institutes of Health.

This demanding and challenging responsibility requires the involvement of all Agencies and Departments having relevant programs. Accordingly, the Secretary chartered a committee chaired by Dr. Fredrickson, to act as a focal point in discharging this obligation. The Committee on Federal Research Into the Biological Effects of Ionizing Radiation has membership drawn from twelve Departments and Agencies, and has begun the process of formulating the Federal strategy.

While the Congressional intent was to limit the strategy to Federally funded or conducted programs, the Committee realized early in its deliberations that the success of the undertaking would depend in large part on its ability to recruit the advice and assistance of a large number of scientists pursuing their research in institutions of higher learning, private and public laboratories, and in private sector industry. ingly, a schedule of activities evolved to permit an interplay between these scientists and Federal officials.

On November 7 we plan to convene a selected group of scientists to consult on the drafting of an outline of research strategy that will be further developed by the Committee. The consultants have beeen chosen because they have an incisive grasp of a well defined area of research and, in many instances, a broad and comprehensive understanding of research issues as they intersect with public policy, consumer concerns, and political realities.

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A preliminary and abbreviated outline of research has been developed by the Committee and contains twelve primary elements forming fairly well defined disciplinary clusters. The outline may provide no more than a starting point for discussion and need not be accepted in either form or substance. Approximately six consultants will be asked as a group to review a single element of this outline for organization, completeness, relevance, scientific opportunity, and the need for research supported by public funds. By the end of the day, we would expect to receive from each group of consultants a relatively detailed compilation of the research agenda they would recommend for Federal support.

From each group of consultants we expect to seek authors for what we have chosen to call "Scientific Projection Papers." These documents may be prepared by single authors or developed collaboratively. Some groups might choose to suggest the name of a scientist who may not have participated in the meeting on November 7 to write the "Projection Paper." The number of "Scientific Projection Papers" needed will vary among the disciplinary areas. We would expect advice on the requisite number.

The "Scientific Projection Papers," oriented toward disciplines, must have as a primary goal a justification for inclusion of the subject matter in a Federal research portfolio. They should be neither a "state of the art" summary nor a compendium of relevant science. Rather, we would expect a carefully reasoned document, placing the particular element of research into perspective, identifying the needs and opportunities, defining scientific questions to be answered, and the relation of this aspect of research to the larger total. At present, we cannot be precise about length, but we do not expect to receive voluminous documents. Ten to twenty typescript pages should suffice.

A limited number of papers of another sort will also be sought. These will be "issue papers" traversing a number of disciplines encompassing not only science related to the biological effects of ionizing radiation, but also the interplay between this body of knowledge and the need for and development of public policy. In addition, they should articulate, whenever appropriate, those problems which research alone cannot solve and must rely on the political process for resolution. This group of "issue papers" will serve to frame the scientific process, delineating both its strengths and limitations, and indicate how research can illuminate and guide the formulation of public policy. It seems particularly important to address matters which are of immediate concern to the public. The Committee will have selected the topics for "issue papers" in advance of November 7, but consultants may feel free to add additional titles.

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All papers must be completed by February 1, 1980. These will be collated, printed, and be made available to the scientific community and to the public after February 20.

On March 10-11, we will convene an open meeting at which time the overall strategy will be discussed publicly. Authors of papers will be asked to present a synopsis of their recommendations, and the audience (Committee members, consumers, public interest groups, public administrators and scientists) will have an opportunity to comment, challenge or bless.

The product of this meeting should provide the essential material needed by the Committee on Federal Research Into the Biological Effects of Ionizing Radiation to fashion a well-groomed "Draft Federal Strategy." This "Draft" will be forwarded to a committee of the National Academy of sciences for review on or before May 1, 1980. The Academy has a sitting committee reviewing current Federal research into the biological effects of ionizing radiation and will thus be uniquely prepared to provide a critique of the "Draft Federal Strategy." Within two months, the Academy Committee will return the "Draft" with comments, at which time the Committee will consider further recommended changes and modifications. It will be submitted in final form to the Secretary, Department of Health, Education, and Welfare for transmittal to the Congress by December 31, 1980.

This letter carries with it an expression of appreciation from the Committee and its chairman Dr. Donald S. Fredrickson. We are pleased that you have agreed to consult on this very demanding responsibility.

Should you have any questions, please feel free to contact me (301-496-3283) or my associates whose telephone numbers are noted at the bottom of this letter.

Dr. Oddvar F. Nygaard

Special Assistant to the Director
National Cancer Institute

Dr. Elliott H. Stonehill
Research Planning Officer
National Cancer Institute

Sincerely,

Charles U. Lowe, M.D.
Special Assistant to
the Director

1

317 Pennsylvania Ave. S.E. Washington, D.C. 20003
202/544-8200

November 6, 1979

Dr. Donald Fredricks on

Director

National Institutes of Health

9000 Rockville Pike

Bldg. 1, Room 124

Rockville, Maryland 20014

Dear Dr. Fredrickson:

I am writing pursuant to the Freedom of Information Act as amended (5 U.S.C. 552), regarding health effects research of the people exposed to ionizing radiation from the Three Mile Island nuclear reactor accident and post-accident clean-up. I, therefore, am specifically requesting the following information:

(1) Minutes of all Interagency Radiation Research Committee (established under PL. 95-622) meetings concerning discussions of the Three Mile Island Island accident and post-accident clean-up.

(2) All correspondence between the National Institutes of Health representatives and other Interagency Radiation Research Committee members concerning the Three Mile Island accident and post-accident clean-up.

(3) All correspondence between the Interagency Radiation Research Committee and the Kemmeny Commission concerning the Three Mile Island Accident and post accident clean-up.

(4) All research protocols concerning health effects research which were reviewed or discussed by the Interagency Radiation Research Committee.

(5) All dosemetric data relative to radiation exposure to workers at the Three Mile Island Accident (film badge readings, bioassays, and in vivo counts) and post accident clean-up.

I am prepared to pay reasonable costs for locating the requested files and reproducing it. As a tax exempt organization, however, the fees should be waived. Other organizations and individuals will also want copies of these documents and it is unfair for the Environmental Policy Institute, as the first requester, bear full costs for the initial material search. The amended Act does provide that fees may be reduced or waived if it "is in the public interest because furnishing the information can be considered as primarily benefitting the public." I believe this request plainly fits that category because the file contains vital information about the health and safety of several thousand people who may have been exposed to ionizing radiation from the Three Mile Island accident. The Institute, as the primary national group working on ionizing radiation public policy issues, will be using the information to inform the public and to initiate any needed changes in current policies. I therefore ask you to waive any fees. If you rule otherwise, and if the fees will exceed $10.00, please inform me of the charges before filling my request.

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If you have any question regarding this request, please telephone me at the number listed on the first page of this letter

As provided in the Freedom of Information Act, I will expect to receive a reply within 10 working days.

Sincerely,

Robert Alvary

Robert Alvarez, Director

Radiation Health Information Project

cc:

Mr. Russel M. Roberts

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