IA-85-309, Draft Commission Paper Re Status of Ongoing Staff Work Concerning Mancuso Study & Response to Senator Brooke Questions on Study
| ML20133C742 | |
| Person / Time | |
|---|---|
| Issue date: | 02/10/1977 |
| From: | Minogue R NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | |
| Shared Package | |
| ML20133C731 | List: |
| References | |
| FOIA-85-309 SECY-77-087, SECY-77-87, NUDOCS 8507200560 | |
| Download: ML20133C742 (7) | |
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.T.0,: The Comissioners FROM: Robert B. Minogue, Director '
Office of Standards Development , , ,,,,,,
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SUBJECT:
MANCUS0 STUDY PURPOSE: To inform the Comission of the status of on-going staff work relating to the Mancuso study and of a response to questions on the study asked by Senator Brooke.
DISCUSSION: By memorandum of October 27,1975, we informed the Comission'of a study by Mancuso, Ste.4 art, and
., Kneale concerning cancer mortality areng former workers at Hanford. On Novetter 2',1976, we inforced the Comission and Program Offf:e Otra:: ors of the
- completion of a staff review of the study. The review l
concluded that the report did not warrant Regulatory action at this time to change either the dose limiting
' regulations of 10 CFR or the rethods of analysis of radiation effects now in use by NRC staff. Thus, there is continued assurance that activities licensed in accord with the current regulations provide protection of the health and safety of the public and radiation l workers.
Subsequently, the staff has appeared in several reactor licensing hearings and in the CRBR and GESMO hearings to testify on these preliminary findings. In addition we have been in centact with other Federal agencies having responsibilities in this area, namely, the Bureau of Radiological Health, the National Cancer Institute, the Energy Research and Development Administration, and the Environmental Protection Agency.
We have also been in contact with the National Council CONTACT:
R. J. Mattson, SD 443-6953 1
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The Commissioners on Radiation Protection and Measurements. We have found that all of these people share our preliminary conclusions regarding the study. In these discussions we have dis-A cerned a need for further interagency dialogue on the continuing interpretation of such data within the context of broadly shared radiation standards responsibilities.
In the course of the preliminary review of the Mancuso study, the staff was. unable to arrange a meeting with its author. We understand that the study has continued in the interim. In addition, the staff still has some detailed technical questions to raise concerning the preliminary results of the study. Therefore, we have made arrangements to meet with Mancuso, Stewart and Kneale within the next several weeks to discuss the further progress of the study and to obtain their direct input to our continuing review. Stewart and Kneale are returning to the United States to meet with ERDA in a contract review at about that time.
We are planning to brief the Commission in March concerning i the then current status of our review of the work of Mancuso, et. al., and other considerations of the future role of NRC staff in this subject area. It is apparent that other agencies have interest in and responsibilities for the evolving body of information from radiation epidemiology.
We plan to develop recommendations concerning our interaction with and the relative roles of the other agencies.
This subject matter is also related to the NRDC petition for rulemaking (PRM 20-6) pertaining to the occupational exposure limits of 10 CFR Part 20. Staff work on that petition is now approaching the stage of drafting a Commission policy paper. We are presently inclined to recommend denial of the petition for much the same reasons that it was denied by EPA last fall. We expect that this paper will reach the Commission in Mey. -
Senator Brooke has a continued interest in this subject area as indicated by the enclosed letter to Dr. Mattson and the draft response. Chairman Rowden also had a recent exchange of corresponderce with Senator Brooke on this subject. The draft response summarizes the status of staff efforts on the Mancuso study and on PRM 20-6.
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obhld The Honorable Edward W. Brooke United States Senate Washington, D.C. 20510
Dear Senator Brooke:
This is in reply to your letter of December 29, 1976, requesting information about recent studies on the health effects of icw level radiation. I hope that this letter will help to resolve any misunderstanding of the studies in question and to explain our regulatory standards role in this important public health area.
To my knowledge there is only one study of the effects o' !:w level radiation which fits the description provided in your letter. I: is described in a paper entitled, " Radiation Exposures of Hanford Workers :y'ng From Various Causes," which was coauthored by Dr. Thocas Mancuso, Cr. Ali:e Stewar:, and Mr. George Kneale. The paper presents preliminary resCts :# :he study.
It was presented at a meeting of the Health Physics 5::'s:y in Sarat:ga Springs, New York on October 13, 1976. The paper has n:t ye been for ally i published. The study concerned the causes of des:P Of f:rrer workers at -
the Hanford Laboratory and was based on mortality an: radia:icn exposure L statistics collected by the former Atomic Energy C: nission (n w the Energy /
Research and Development Administration). The st.:j did n0: concern the genetic effects of radiation.
One of the responsibilities of this office is the development of radiatien standards for activities licensed by the .'luclear ?.sgulatory Ccmission. This -
requires that our staff routinely follow the general state of knowledge and individual studies concerning radiation effe::s. We were aware of the paper by Mancuso, Stewart and Kneale and co aleted an independent evaluation of the preliminary findings soon after they were ; resented. Copies of letters -
and memoranda describing that evaluatien are provided here in Attachment 1.
These materials were provided to Dr. 3r:ss en Cecember 2, 1976. The principal finding of our analysis was tha: the conclusions reached by Mancuso, Stewart and Kneale could nc: te '"=:ified by the information given in their paper.
We concluded, therefore, that the report did not constitute a valid basis for the immediate revision of our radiation standards or the methods we use for analysis of health effects. There is continued assurance of protection of the health and safety of the public and radiation workers for activities licensed in accord with current NRC regulations.
l The Honorable Edward W. Brooke. s These conclusions were based on our independent analysis of the paper.
Subsequently, we have reviewed the conclusions of an analysis performed at our request by a consultant at the Massachusetts Institute of Technology, and we have compared our conclusions with those of other people in the Federal government who have radiation health responsibilities. In this
-regard, we have talked to representatives of the Bureau of Radiological Health of the Food and Drug Administration, the National Cancer Institute, the Environmental Protection Agency and the Energy Research and Development Administration. We have found that the conclusions of these experts are consistent with ours with regard to the Mancuso study and the particular paper in question.
Although the study by Mancuso et al. is hot sufficient in itself to justify
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immediate regulatory action, it does underscore the fact that there is a still growing body of data which may lead to further clarification of the effects on man of exposure to low levels of radiation. Consideration of these effects is important whether the exposure arises in medicine, consumer products, weapons fallout, or the production of electricity. We remain convinced of the value and need for continued collection and analysis of such data over the long term to support the infor ation requirements of the agencies and individuals responsible for continuing public health decisions. For our part, we will continue to stay aware of the potential i
usefulness of such data in our own standards activities. In this regard, we have made arrangements to meet with Dr. Mancuso, Dr. Stewart and Mr. Kneale in the next few weeks to discuss further their particular study.
Dr. Stewart and Mr. Kneale, both residents of Great Britain, will be returning to the U.S. at that time for further discussiens regarding the study.
I will turn now to Dr. Bross' questions concerning public hearings. There is a formal mechanism by which interested parties may seek to alter NRC regulations. This is by Petition for Rule Making as given in 10 CFR Part 2,
}2.808. There is a provision for holding public hearings in the course of such rulemaking, but public hearings are not mandatory and are not always held. '
In addition to hearings on rulemaking petitions, there are opportunities for public meetings on specific subjects. Our office has sponsored several meetings of this type in the last several years in the general subject area of radiation protection for workers. Announcements of these meetings are published in the Federal Register and persons known to be interested receive timely notification and background information. At these informal meetings,
l The Honorable Edward W. Brooke any interested person may speak out on the subject in question. Questions directed at the staff and other participants are answered. We have found that this forum of informal public meeting is usually conducive to a lively exchange of information and views and is particularly well suited to the preliminary stages of standards development when there is a need to narrow the broad alternatives for solving a particular regulatory problem.
As you know, a petition for rulemaking by the Natural Resources Defense Council (PRM 20-6), requesting that the occupational whole-body radiation dose limit be lowered, was submitted to the NRC on September 16, 1975. The status of our work on that petition was , described to you in Chairman Rowden's letter of October 6,1976 (Attachment 2). We are centinuing our review, consistent with other work priorities, of current scientific information of relevance to the petition, including public comtents on icw level radiation effects, the study by Mancuso, et al., and the work of Cr. 3ress. Also, any new, independent studies by~5ItWart would be factored Sto our considerations of this petition, if they become avaliable in a timely fashion.
We have been corresponding with Dr. Bross for scee -i e !A::acreents 3 and 4). Our understanding is that he is challenging cur te:.mi:al staff to
, participate in an adversary science proceeding with a f:r-at of the tyos described in his correspondence. In cy judgment su:5 a f0r-at is not suitable for the staff of this regulatory agency wht:i has, by statute, a role more akin to umpire than to advocate. Sin:e -le subje:t of interest to Dr. Bross is already being considered in pR'4 20-5 and since nis co- ents are being considered in that context, there is, in rj opinien, no reason for additional rulemaking action.
The course beingfollowed by our staff in handling the NRDC petition for rule-making provides a comprehensive and deliberate investigaticn of this matter and, we feel, is fully responsive to the peti ica and within the bounds of sound regulatory practice. To reiterate fer e :hasis, we are assuring that
- in considering the petition for rulemaking a c:rprehensive body of information bearing on the current understanding of 1:w level radiation effects is being taken into account. In addition to that, and by virtue of the continuing effort on the part of our staff to re. ain abreast of new information on '
radiation effects, the pennissible radiation exposum levels, under NRC .
regulations, are being reassessed continually.
Thank you for your interest in clarifying this matter. If we can be of a
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The Honorable Edward W. Brooke -4 further assistance, please advise. This correspondence is being entered in the public docket files of PRM 20-6 and I have provided copies to Dr. Bross and to the petitioner to keep them aware of activities in connection with the petition.
Sincerely, Roger A. Mattson, Director Division of Siting, Health &
Safeguards Standards Office of_ Standards Cavelopment
Enclosures:
See attached list cc: Dr. I. D. J. Bross NRC Public Document Room L
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