ML20128H113

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Summary of ACRS 432nd Meeting in Rockville,Md Re Health Effects of Low Levels of Ionizing Radiation
ML20128H113
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Issue date: 06/14/1996
From:
Advisory Committee on Reactor Safeguards
To:
Advisory Committee on Reactor Safeguards
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ML20128H116 List:
References
ACRS-GENERAL, NACNUCLE, NUDOCS 9610090241
Download: ML20128H113 (11)


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ADVISORY COMMITTEE ON REACTOR SAFEGUARDS 432ND MEETING HEALTH EFFECTS OF LOW LEVELS OF IONIZING RADIATION JUNE 14, 1996 ROCKVILLE, MARYLAND

- TABLE OF CONTENTS -

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1. T a bl e o f C o n t e n t s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 I
2. Proposed Agenda ..................................................... 2
3. Status Report........................................................ 3
4. References

Subject:

Health Effects of Low levels of Ionizing Radiation . . . . . . . . . . . . . . . .. 5

. Memorandum dated May 18, 1996, from Dr. Dana Powers, ACRS, to l Roxanne Summers, Technical Secretary,

Subject:

Health Effects of l Low levels of Ionizing Radiation . . . . . . . . . . . . . . . . . . 11 l l

. Memorandum dated May 5,1996, from Dr. Dana Powers, ACRS, to Ms. l Roxanne Sunners, Technical Secretary,

Subject:

Health Effects of Low levels of Ionizing Radiation . . . . . . . . . . . . . . . . . . 14

. Memorandum dated May 18, 1996, from Dr. Martin Steindler, ACNW, to Dr. John Garrick, ACNW,

Subject:

Health Fffects Letter . . . . . . . 15

  • Memorandum dated March 24, 1996, from Mr. Jay Carroll, ACRS, to Mr.

John Larkins, ACRS Executive Director,

Subject:

3/26/96 ACRS/ACNW Joint Subcommittee Meeting . . . . . . . . . . . . . . . . . . . . . 16

  • Draft Work Scope dated May 2,1996, approved Mr. Carl Paperiello, NMSS,

Subject:

BEIR VII " Scoping Study" .............. 18

. Technical Proposal Summary dated February 10, 1995, from National Council on Radiation Protection and Measurements, to NRC,

Subject:

Assessment of Biological Studies Associa'ed with Health Effects of Low levels of Ionizing Radiation . . . . . . . . . . . . . . . . . . 24 Coanizant ACRS Member: T. Kress

, Coanizant ACRS Staff EnaiDigt: N. Dudley [._ R /

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9610090241 960614 PDR ACRS GENERAL PDR -

. 1 ADVISORY COMMITTEE ON REACTOR SAFEGUARDS 432ND MEETING HEALTH EFFECTS OF LOW LEVELS OF IONIZING RADIATION JUNE 14, 1996 ROCKVILLE, MARYLAND

-AGENDA-Presentation Lenath Time

! Introduction - Dr. T. S. Kress 5 min 8:35-8:40 a.m.

II. Staff Presentation - Dr. John Glenn, 30 min 8:40-9:ld a.m.

MNSS III. Dr. Myron Pollycove, NRC Visiting 25 min 9:10-9:35 a.m Medical Fellow IV. Dr. Marvin Goldman, Invited Expert 25 min 9:35-10:00 a.m 2

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, ADVISORY COMMITTEE ON REACTOR SAFEGUARDS 432ND MEETING HEALTH EFFECTS OF LOW LEVELS OF IONIZING RADIATION JUNE 14, 1996 ROCKVILLE, MARYLAND

-STATUS REPORT-PURPOSE

The Committee will hear briefings by and hold discussions with representatives

! of the NRC staff and the Health Physics Society, and invited experts concerning the health effects of low levels of ionizing radiatio).

BACKGROUlO The ACRS/ACNW Subcommittee met on March 26, 1996. Mr. Carl Paperiello, NMSS, Mr.

James Muckerheide, Massachusetts Emergency Management Agency, Prof. Ronald Kathren, National Council for Radiation Protection and Measurements (NCRP), Mr.

Charles Willis, Health Physics Society, and Dr. Myron Pollycove, NRC visiting medical fellow, briefed the Subcommittee on the health effects of low level.s of ionizing radiation. The ACNW met on May 15, 1996, heard briefings, held discussions, and approved a report to the Commission on this issue.

ACNW REPORT i

On May 17, 1996, members of the ACRS, ACNW, and ACRS/ACNW staff participated in a conference call to discuss the ACNW report. Subsequently, changes were made to the report [pp. 5-11] and the ACRS decided to hear a briefing on this subject in order to act on the ACNW report. Dr. Powers provided comments on the report before (p. 12] and after [pp. 13-15] the conference call. Dr. Garrick provided comments [p. 16] on the suggested changes to the ACNW report made by Dr. Kress

and Dr. Shack.

LINEAR NO-THRESHOLD DOSE-RESPONSE MODEL -

Prof. Kathren provided the ACNW a Pre-Publication Copy of an article titled,

" Pathway To a Paradigm: The Linear No-Threshold Dose-Response Model in Historical

Context." The model was originally used to provide an upper limit estimate of the risk of radiation exposure and was developed by extrapolating data of fatal cancers caused by high radiation doses to low-level doses. Prof. Kathren stated

! in his cover letter that a large body of evidence supports response curves other than the linear no-threshold curve. He cautioned against changing the curve until a "more definitive and less equivocal understanding to the shape of the low dose response curve is obtained," and suggests establishing an interim de minimis 4

annual level between 10 and 1000 pSV (1-100 mrem).

OBJECTIONS TO THE LINEAR NO-THRESHOLD DOSE-RESPONSE MODEL i

For years researchers and health physics professionals have been questioning the no-threshold model and have proposed various changes to the curve. Studies, articles, and data on the effects of low levels of radiation exist and research 3

. t in this areas is continuing. Examples of recent activities include:

an article by Dr. Pollycove that identifies significant positive health effects associated with low level radiation based on a review of five l j epidemiologic studies, )

a the 1994 American Nuclear Society Annual meeting session on the results of l a nuclear shipyard worker study that refutes the no-threshold model, I the March 1996 Health Physics Society position statement that recommends against quantitative estimations of health risk below an individual dose of 5 Rem in one year and a lifetime dose of 10 Rem in addition to l background radiation, l

the May 1996 Health Physics Society's Newsletter that includes reactions to the Health Physics Society's position paper, and I

the June 1996 Health Physics: The Radiation Protection Journal that includes several papers associated with the linear no-threshold model and the dose effects of low levels of radiation.

NRC ACTIVITIES RELATED TO THE NO-THRESH 0LD MODEL In a March 23, 1996 memorandum, Mr. Jay Carroll stated that the ACRS and ACNW

, "Comittees, either individually or jointly, should recommend to the Comission that the agency develop a proactive strategy to settle the question of health effects of low level radiation exposure." [pp.17-18] j On May 2,1996, Mr. Carl Paperiello, NMSS, approved a Draft Work Scope [pp.19-22), which proposed that the Board on Radiation Effects Research organize a small expert panel to investigate what issues a BEIR VII study might address. The position paper outlined the issues and areas the expert panel should consider.

On February 10, 1995, the NCRP submitted a technical proposal summary [pp. 23-29]

to the NRC. The objective of the proposal is to make a critical scientific assessment of all biological studies of the effects of ionizing radiation, and radiobiological theory of effects, in the low-dose and the dose-rate region and then to summarize these effects. The NRC formed a panel to assess these issues.

, SUBCOMMITTEE ACTION I

The Committee is expected to act on the report approved by the ACNW.

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4 FINAL DRAFT 1B MJS/BJG May 17, 1996 4

i The Honorable Shirley Ann Jackson i Chairman U.S. Nuclear Regulatory Commission Washington DC 20555-0001

Dear Chairman Jackson:

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SUBJECT:

HEALTH EFFECTS OF LOW-LEVELS OF IONIZING RADIATION The health effects of ionizing radiation are central to many of the regulations that are promulgated by the Nuclear Regulatory Commission (NRC). Recently, Tthe validity of the linear, no-threshold (LNT) dose-response relationships in the area of low doses and low dose rates has been questioned. It is the purpose

, of this letter to recommend a course of action for the Commission in the review and analysis of this important issue.

4 Our. discussion and recommendations concerning this subject derive from the first meeting of the Joint Subcommittee of the Advisory 4

Committee on Reactor Safeguards (ACRS) and the Advisory Committee 1

! on Nuclear Waste (ACNW), held on March 26, 1996, as well as I a

separate deliberations by each Committee. Presentations were I

made by members of the NRC staff, including the visiting medical I

fellow, and representatives from institutions and agencies, including the National Council on Radiation Protection and Measurements (NCRP), the Health Physics Society, and the J

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Massachusetts Emergency Management Agency. Written comments were also received from the public.

Most national and international scientific committees dealing with the subject take the viaw that the safest approach to i regulation is one that relies on the 44near r-no-threshM LNT i

model of response to doses of ionizing radiation. This model I

holds that the ill health effects observed at high doses and high I

dose rates (mainly among atomic bomb survivors) can be extrapolated linearly to low doses and low dose rates, down to' f the smallest doses. The NRC staff prepares regulations based on this model. One of the basic questions in this field is whether 1

the LNT model is valid at the low doses encountered in many of the regulatory domains. The increasing emphasis placed by the Commission on risk-informed regulation makes it imperative that i

the actual health risk of low levels of ionizing radiation be

] assessed accurately.

d The NRC is currently funding a contract with the NCRP to make a critical evaluation of the LNT assumption. While the ACRS and 1

i ACNW have not reached any conclusions on the validity of the LNT l model, and will continue to study the matter, we consider the issue of sufficient importance to recommend that the Commission i

) initiate independent and special technical investigations to provide an impartial review of the data and their quality.

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3 The presence of unavoidable background radiation and the need for

i very large samples have made it difficult in the past to provide '

definitive data on the validity of the LNT model. As with all

, small-effect phenomena, the quality of the data and the statistical interpretation of the results govern the ability of i

, any study to contribute to the testing of the model. However,

investigators in the field have recently been able to provide i methods to account for the impact of confounding factors such as variation in background radiation. Some studies in the United States as well as in China, Sweden, Poland, and Canada have i arrived at conclusions that do not support the LNT model. Other research concludes that it is likely that at least a threshold or l perhaps a corresponding zero equivalent point with beneficial risk decrements (hormesis) exists at lower doses.

4 1 A notable example of the latter was a 10-year study by Johns Hopkins University of U.S. shipyard workers which, we were told, showed lower mortality, no increase in malignancies among workers exposed to radiation when compared to those who were not exposed, 1

and no " healthy worker effect." This study may be particularly significant since the investigators sought to find evidence to support the LNT model. Another study, of Canadian women patients in tuberculosis ranitariums who underwent repeated fluoroscopy to monitor response to therapy, is used frequently to show the validity of the LNT model, but examination of data at lower doses shows significant beneficial effects. The 1994 report of the

4 United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) has an extensive appendix detailing cellular repair mechanisms (called " adaptive response mechanisms") that could contribute to an explanation of a threshold, or, if such cellular responses were stimulated by low doses of radiation, to an explanation of beneficial effects.

In contrast, some of the public comments received by the Joint ACRS/ACNW Subcommittee suggested that the LNT model underestimates the harmful ef fects of low doses of radiation. '

Also an NCRP Report, " Principles and Application of Collective Dose in Radiation Protection," issued as late as November 1995, and discussed with the Joint Subcommittee at its March 26, 1996 meeting, finds that "...from the point of view of the scientific bases of collective doses for radiation protection purposes, it is prudent to assume the effect per unit dose in the low-dose region following single acute exposures or low-dose fractions is a linear response."

In the face of conflicting views, the general belief of the national and international committees dealing with the matter has been that using the LNT model for regulatory purposes is a safe and conservative approach, and if there is error, it should be on the side of enhanced protection. However, if there is a health benefit at low doses, suchthis logic is clearly mistaken-and eent4euleg the current-po14cicc wouM-place t4m--somfwiccion iethe 8

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pos4 tion of prevent-imy-th4s-benefit-from-oecurring incorrect.

Even if there is no health benefit, there are significant societal costs associated with this conservatism that could be I avoided or reduced if a threshold level could be established ,

I below which no harm occurs. The basic principle of risk-informed regulation is to prevent a situation where scarce resources are misspent to avoid negligible risks, while significant risks remain unattenuated for want of resources to deal with them.  !

Owing to the potentially significant costs of the present conservatism, we conclude that a reexamination of the regulatory model is appropriate.

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It is obvious that agreement on a calent4fically based an appropriate dose-response model is made more difficult by the differing voices on this subject within the scientific community and those outside of this community, including regulators, policy makers, and members of the public. The first task required to reach such an agreement now is te-provide an impartial review of the data and their quality in the face of the extensive application of the LNT model in regulations and scientific opinion. Thecc feeters lead te-the fc110 wing recc=endat-ient We recommend that @the NRC chould-create an independent body to examine and critically evaluate all the current scientific evidence on the relationship between low dose and health effects with special emphasis on the experimental conditions and 2

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6 practices and the quality control exercised. To ensure independence, the expertise of the participants in this review i

should include impartial information scientists who are 4

experienced and expert in assessing the quality and treatment of data and experimental results. Such emphasis is designed to overcome any bias of dose-response experts, many of whom are 4

strongly committed to their traditional positions. This approach has the advantage of being able to reach out to experts and institutions with little or no prior position on this issue.

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If, instead, the Commission prefers to support only the limited

} NCRP evaluation of the LNT assumptions, we recommend that the l need for special attention be conveyed to the NCRP. Such 1

l attention should include (a) accign=cnt of impartial assurance that the study includes scientists tc the tudy not-Only other

than those who are " recognized experts" with a reputation built i

i on the LNT model, (b) an additional component 50 added to - t-he k study 30 that an impart 4al- an evaluation of the data by an l entity with expertise in statistics or information science, but i

j no prior position on LNT such as the National Institute of a

j Standards and Technology (NIST), vill cxamine the canc data as well as the NCRP study committee, and (c) a rcqucat to the NCRP i tc most accuredly include in its revicu consideration of

essentially all studies related to the LNT.

The Committees are unanimous in their opinion that the goal of

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these studies should be to ground regulatory actions on good science, supported by evidence and as independent as possible of extraneous factors. The Committees believe this topic to be of very great importance and plan to continue their analysis and review of information.

Advisory Committee on Reactor Safeguards I

Advisory Committee on Nuclear Waste l e

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03 85 es 19:23 F G 50$B2t0245 l

To: Roxanne Summers D e m CL 9 e _o 4 From: Dana A Powers j l I 4 1 Sub;ect: HEALTH EFFECTS OF LOW-LEVELS OF IONIZLNG RADL-\ TION l l

l I have just recently re:umed home and have had just a brief oppor uni:y :o examine the facsimile transmission of the draft letter entitled "Heali Effects of Low levels oflonizing i 2

Radiation". I don': support this le:ter. My objectiors to ie lener are at several levels Overall I l feel the ie:ter is too narrow of a focus It seems :o treat 6e issues of radiation as though they l were all caused by the shine exposure pathway. In fact, the U.S. Nuclear Regulatory Comrnission i 4

must confront ireats of radiation exposure by all pathways. Shine may be the least troublesorne j of the pathways. Assuredly it is the best understood. Uncertainties in the form and uptake of j radioactive mate-ials are huge and largely unquanti5ed. If there is any conservatism in the linear. i no threshold assumption, its effects must pale in the face of these tremendous uncertainties, It I 2

would seem then tha: a far more holistic approach to the issues of radiation exposure ought to be recommended rather 6an the narrow issue raised in the let:er.

The recommenda: ion for a unilateral NRC examina: ion of the linear. no threshold l approximation appears ill-advised. Such an examination :ould have no impact. It is unhkely a unilateral conclusion by SRC researchers could ever be successfully implemented into

regu
sticas. The visible, dramatic change away from 6e traditional linear hypothesis will come

, abou: when there is much more of a unanirrury among specialists involved in the study of radiation e:Tects It would seem, Gen, to me that it would be far bener to recommend to the Cornmissioners that they assure NRC continues to participate in world-wide bodies addressing

, ie issues of radiation exposure. An anempt by NRC to "go it alone" would be simply a waste of money and effon.

I have no interest in transmitting te letter in anything like its current form to the l Cemrnissioners. I would have lengthy, strongly-worded added commems to a similar letter transmined by te ACRS. I think it would be reg enable if the ACNW chose to adopt ie :e ter urulatera'ly.

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