ML20029C359

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Forwards Proposed Agenda for Regional Below Regulatory Concern Workshops.W/Related Info
ML20029C359
Person / Time
Issue date: 06/07/1990
From: Paperiello C
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
Shared Package
ML16252A423 List:
References
FOIA-90-415, FRN-53FR49886, RULE-PR-CHP1 NUDOCS 9103270217
Download: ML20029C359 (18)


Text

{{#Wiki_filter:. c,c f s m a June 7, 1990 a iMEHORANDUMFOR: 'BRC' Steering Group Members iFROM:: 1 Carl J. Paperiello, Depu_ty Regional Administrator

SUBJECL PROPOSED AGENDA FOR REGIONAL. BRC WORKSHOPS 4

x Pliasefindattachedaiproposedagenda;foraregionalBRCWorkshop. 'thiscagenda and_ related issues with Jan Strasma, our:Public Affairs Officer, . I discussed ,.Hr feels that"for Regi_on IIIrplans should be made for a meeting attendance of about--300.J This-is, however. onl ihaving/some public interest.- As'y a: guess' based on past experience with issues-VAlthoughithe agenda shows the meeting starting at 9:00 a.m. :it could start-set up, i f lanyf time.::Iticould be run as-an evening program if substantial general public

l ipresenceiis envisioned.

c i )I believe th' reishould be continuity and uniformity in;these )res e q g j ithe regional <spokesperson::using a prepared presentation that would be the same ~ itnjeach; Region ' I-also. propose that the same:NMSS R !participatelin;all;five regional workshops;J1f thIs'ES and OGC.spokespersons d istnot-1still_ limit;the? number of.spokespersons and_use_ prepared pre:-practical I would iThey should either read the NAS Study, Iall participantsEneed to be: sensitive sentations; Lastly 1 e e hould haveja training -session' on this'Jm roving Risk Comunication~,Jor we - -i s -topic for NRCLBRC spokespersons.; cI: suggestirunning al trial workshop te getia feel on" turnout andLthe type?of a sissuesithat might:arise. I.am:asking the Steering Group Hembers:to consider:cthesaboveJissues-an .-u 4 itimes appear reasonable?. n

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3/s/,CarliJ. Paperiello- . Car,lM.?Paperiello: = L -. Deputy Regional'Administratori 1

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T AsLstated m \\ JRIII- / LPapertello/db - M 06/://90 ,f T 9103270217 910320 PDR FOIA BECKER90-415 PDR 4 _____.._________m.

~, DRAFT s > 4. := AGENDA 9:00 Welcome(Regional: Administrator) 9:15 Introduction This presentation would Icy out a brief history of Comission The overall goal of the. policy would be stated. exemption policy and the g 20 min.) Regional Spokesperson 9:45 Basis of the Limits (Individual Limits, Collective Dose Limit) This presentation would be a discussion of the derivation of the limits. It would include discussions of natural background variation . and r.isk estimates. - (30 min.) Research Spokesperson 10:15-Break 10:30 Application.of Policy This presentation would include. a discussion 'of rulemaking and licer, sing using the policy. The administrative mechanisms for implementing the policy, will. be discussed. Existing exemptions would be discussed as well as potential new areas such as waste disposal, recycle, and decomissioning. -(30 min.) NHSS Spokesperson 11:00. Question and Answer' Panel In addition _to the above, an OGC npresentative should be available. I envision:a one hour session with a lunch break. If-there is ..enough. interest I-would add a session in the afternoon. . p,<yp L.y p<, s m l 5 l

o-C@ F AGENDA BRC STEERING GROUP bc.ETING JUNE 11, 1990 1. Schedule 2. Current Status of Policy Statement 3. Letter to Congress / Governors 4. Briefings with other agencies 5. Regional workshops

. ~_ _.. wwe - 7 - l {i Useful Quotes on Health Effects of Radiation 1 (Reft National Research Council, 1990, " Health Effects of Exposure to Low Levels of Ionizing Radiation, BEIR V") 1. Studies of populations chronically exposed to. low-level radiation, such as those residing in regions of elevated natural background radiation, have not shown consistent or conclusive evidence of an associated increase in the risk of cancer. pg. 5 2. On the-basis of available evidence, the population-weighted-average lifetime excess risk-of death fron-cancer following an acute dose equivalent to all body-organs of 0.1 Sv-(0.1 Gy of low-LET radiation) is estimated to be 0.8%, although the lifocime risk varies considerably with age:at the time i of evposure. For low LET-radiation, accumulation of the -l same dose over weeks or months, however, is expected to reduce the-lifetime risk appreciably, possibly by a factor of 2 or more. pg. 6 3. The committee recognizes that its riwk estimates _become more uncertain when applied to very low doses. Departures from a linear model at low doses, however, could either increase-or decrease-the risk per unit dose. pg. 6 4. The-data now reveal'the magnitude of (the risk of mental retardation in Japanese A-bomb survivors exposed at 8-15 weeks of-g 1stational age) to be approximately -a -4% chance of occurrence per 0.1 Sv, but with less risk occurring for exposures at other-gestational ages.. pg. 7 5. Based on =our review of relevant data from humans,- other-mammals, and ' mice,. the BIER V Committee believes that.... -the-doubling _ dose in humans is not-likely to be smaller than the approximate-1-!ht (100-Rem) obtained from studies in -mice. -pg.-68 .6.- Although scientists understand some of-the-intra-cellular processes.that are: initiated or' stimulated ~by radiation and which may eventually result inia cancer, the level of- ~ _ understanding is' insufficient at present to: enable prediction of the exact' outcome:in-irradiated cells. pg. -161 7. their radiation doses'were negligible--less-than 0.005 Gy (O. 51 rad)[ pg. 162 8. 1Even though modern-statistical methodologies facilitate the -analysis of highly stratified data,- thelfact remains that-- the number-of cases in a given. dose, age, and time interval -is small and often zero. pg. 163 - 9. Moreover, epidemiologic data cannot figorously exclude the-l kl$ --+!v-[., ,.v y-g e g 9 -y d..-c --+m-e,w+- + - - = - - - +-v-- e=re--

.m. 3 N. _ existence of a threshold in the millislevert dose range. ~ Thus, the possibility that there may be no risks from .i exposures comparable to. external natural background radiation cannot be ruled out. eat such low doses and dose rates,11t must be acknowledged that the 1cuer limit of the-range of uncertainty in the risk estimates extends to zero. pg. 181 10. No increase in the frequency of cancer has been documented in populations _ residing in areas of high natural background radiation, pg. 385 (Ref: - Miller, Robert W. (National Cancer Institute), 1990, " Effects of Prenatal riposure to Ionizing Radiation," Health Physics, Vol. 59, No. t, pp. 57-61) 11. There is widespread misunderstanding about mental retardation as an effect of lot dose ionizing = radiation. The recent report by the Committee on the Biological Effects of Ionizing Radiation (BEIR V, 1990) states that analysis of a linear;model suggested 'that a threshold may exist at 0.2-0.4-Gy." The bar graph in the recort shows little, if any, increase among persons who received less than 0.5-0.99 Gy.-- _ pg.-58 12. The lowest dose at which small head size was found among those exposed under 18 wh of gestational age was 0,10-0.19-Gy in air in Hiroshima.- pp 58 . [Ref:. Shore,s Roy E. (New--York bniversity Medical.-Center), 1990, " Occupational Radiation Studies:. Status, Problems, and Prospects," Hgalth Physics, Vol.f59, No. 1, pp. 63-68) ' 13. Hence,31t is1 highly.likely that-risk estimates derived by_ selecting the significant differences in low-dose: studies'of. small to moderate size-will-be' substantial;ty biased in-the upward-direction.- pg. 65-14.- In high-dose ~ studies whers the; excess: risk may be on the order of several hundred percent, biases of 5 or 10%-are-relatively' unimportant._- However,11n low-dose? studies.the possible biases.may:equa1 Lor? exceed the magnitude of expected 1 effects,andJshould be seriously considered as? possible reasons for unexpected:results. -pg.~65' . [Ref: _Schull, W1111am.J., Shimizu, Y.,1and H. Kato (Radiation-- Effects Research Foundation)', 1990, " Hiroshima and Nagasaki: New. Doses,-Risks, and Their Implications," Health Physics, Vol. 59,. No._1,;pp. 69-75) 15. As noted previously, the lowest specific absorbed dose at 4 which unequivocal effectu-can be demonstrated among:the A - bomb survivors is 0.20 - 0.49 Gy,cbut this is a dose substantially-above that of most regulatory concern. pg. 73 e n.

1 l \\ e 16. l~ ~ /:ted rir~ can be seen at doses below 0.5 Gy. pg. 72 17. As far as (eniu a of survivors conceived and born subsequent to the bombing), some 75,000 p- 'nns, is concerned, no evidence has emerged of an r reased risk of cancer, including leuk-mia, whereas an elevo* ion has been reported in other stud >t of preconception t (posure. It must be borne in mind, however, that the bulx of these individuals are only now reaching the ages at which the risk of cancer becomes appreciable. pg. 72 (Reft Fabrikant, Jacob I. (University of California), 1990, " Factors that Hodify Risks of Radiation-Induced Cancer," HgA11b chysign, Vol. 59, No. 1, pp. 77-87) 18. In NCRP Report No. 64 (NCRP 1980), a ' low' dose of sparsely ionizing radiation is arbitrarily defined as 0-0.2 Gy; ' low' do'e rate is defined as less than 0.05 Gy/yr. pg. 77 s 19. Overall, it was concluded by t.:" '4:IR III Committee (1980) that some experimental and humin d>ca, as well as theoreticul considerations, suge aced that for exposure to low-LET radiation at low doses, the linear relationship may lead to an overestimate of the ris'r, of most radiation-induced concers in humans, but that the model could be used to define the upper limits of risk. pg. 78 20. It is only for leukemia, and cancers of the breast, bone, salivary glands, and thyroid, that there appears to be sufficient experience in which to base risk coefficients for those exposed under age 10 y. pg. 84 21. It has not been possible to reliably show that doses of 50 mGy or less have any influence on the likelihood of cancer since the excess risk, if any, is lost in the background of the natural cancer incidence. In this regard, the BEIR III Committee (1980) was unwilling to determine estimates for C acute doses below 0.1 Gy or for continuous exposure to less than 20 mGy/yr. The BEIR V Committee (1990) chose to somewhat less conservative by extending risk projections to 0* the 10-mGy realm. pg. 84 m 22. Radiation is a known carcinogen that causes cancer in a largely random manner. When a large number of people have 4 received a moderate-to-large amount of radiation, the 0I numbers of cancers of specific tissue and organ sites (e.g., leukemia, breast cancer, and lung cancer) produced by that radiation can be estimated. However, it cannot be predicted 37 which individuals will develop cancer, and after the cancer e has developed, whether it was caused by radiation. It is usually not possible to dif ferentiate cancers induced by y, radiation from those that occur spontaneously in the g population. pg. 85 a N 8 8 m ._mf

u m I O h l L. 1 1 i 16. No olevated risk can be seen at doses below 0.5 Gy. pg. 72 17. As far as (children of survivors conceived and born aubsequent to the bombing), somo 75,000 persons, is eincerned, no evidence has emerged of an increased risk of cancer, including leukemia, whereas an elevation has been reported in other studies of preconception exposure. It must be borne in mind, however, that the bulk of these individuals are only now reaching the ages at which the risk a of cancer becomes appreciable. pg. 72 (Reft Fabrikant, Jacob I. (University of California), 1990, " Factors that Hodify Risks of Radiation-Induced Cancer," Health RhyAlpa, Vol. 59, No. 1, pp. 77-87) 18. In NCRP Report No. 64 (NCRP 1980), a ' low' dose of sparsely ionizing radiation is arbitrarily defined as 0-0.2 Gy; ' low' dose rate is defined as less than 0.05 Gy/yr. pg. 77 19. Overall, it was concluded by the BEIR III Committee (1980) that some experimental and human data, as well as theoretical considerations, suggested that for exposure to low-LET radiation at low doses, the linear relationship may lead to an overr 4 mate of the risk of most radiation-induced cancers 4a humans, but that the model cruld be used to define the upper limits of risk. pg. 78 20. It is only for leukemia, and cancers of the breast, bone, salivary glands, and thyroid, that there appears to be sufficient experience in which to base risk coefficients for those exposed under age 10 y. pg. 84 21. It has not been possible to reliably show that doses of 50 nGy or less have any influence on the likelihood of canjer since the excess risk, if any, is lost in the background of the natural cancer incidence. In this regard, the BEIR III Committee (1980) was unwilling to determine estimates for acute doses below 0.1 Gy or for continuous exposure to less chan 10 mGy/yr. The BEIR V Committee (1990) chose to somewhat less conservative by extending risk projections to the 10-mGy realm, pg. 84 22. Radiation is a known carcinogen that causes :ancer in a largely random manner. When a large number of people have received a moderate-to-large amount of radiation, the numbers of cancers of specific tissue and organ sites (e.g., leukemia, breast cancer, and lung cancer) produced by that radiation can be estimated. However, it cannot be predicted which individuals will develop cancer, and after the cancer has developed, whether it was caused by radiation. It is usually not possible to differentiate cancers induced by radiation from those that occur spontaneously in the population. pg. 85

/* (Reft Fabrikant, Jacob I. (University of California and Chairman of BEIR IV Committoo), 1990, " Radon and Lung Cancer: The BEIR IV Report," llealth Physics, Vol. 59, No. 1, pp. 89-97) 23. Within the soil, Rn-222 concentrations can exceed 1000 pCi/1. outdoor concentrations very considerably, but average about 0.2 pCi/1 with mucn higher concentrations at ground level. The major pathway of exposure of members of the general public is through exposure indoors, where an average of 70-80% of time is spent. Because closed structures do not allow for extensive mixing of air, concentrations of Rn in buildings tend to be higher than cutdoor concentrations. Indoor concentrations of Rn-222 in the United States are only modcrately higher, averaging about 1.5 pCi/1, and up to 8 pCi/1 or more when ventilation is not greatly restricted (Noro et al. 1986). These indoor Rn concentrations can vary widely from the ambient air outdoor value to values that are a few thousand times higher (NCRP 1989). Measurements show an apparent lognormal distribution of concentrations in indoor air based on surveys in homes. About 2% of U.S. homes are estimated to exceet 8 pCi/1. pg. 89 24. To provide some perspective of the lung cancer risk from Rn exposure, comparisons might be made with the expected risk in the United States. An estimated 130,000 lung cancer deaths occurred in 1986: 89,000 in malee and 44,000 in females. About one death in 20 is from lung cancer, a lifetime risk of 5%. It has been estimated that cigarette smoking is responsible for 85% of lung cancers among men and 75% among women -- some 83% overall. The lifetime risk of lung cancer for nonsmokars is somewhat less than 1% It has been estimated that passive smoking may be a contributor to this 1% in U.S. nonsmokers, on average, a smoker's risk is about 10 times that of.a nonsmoker. The risk of Rn-induced lung cancer among residents of single family homes in the United States (approximately 70% of the housing stock) has been estimated using the time-since-exposure relative risk projection models developed by the BEIR IV Committee (Lubin and Bolce 1989). These models, based on extrapolation to low Rn exposure levels from higher doses among the Rn-exposed miners, predicted that approximately 14% of lung career deaths among such home residents (about l's,000 deaths per year or 10% of all U.S. lung cancer deaths) may be from Indoor Rn exposure. The 95% confidence intervals are 7-25%, or approximately 6,600 to 24,000 lung cancer deaths per year. ...The models predict that total annual lung cancer burden in the United States would dec case by 4 to 5%, or by about 3,800 lung cancer deaths per year if indoor levels were reduced to 4 pCi/1. This is in contrast to a maximum l =, i

~'~ ^~ ^^^"^~^^ - ^ --~ ^^ ^~ ~ ~ ^ - ^ - ' ~ ^' ^' ^ l. reduction of lung cancer deaths of 14% if all indoor Rn exposures were eliminated. pg. 95 [ Ret: Abrahamson, S. (Radiation Effects Research Foundation), 1990, " Risk Estimatest Past, Present, and Future," Health Rhysics, Vol. 59, No.1, pp. 99-102) 25. There are no results in any human study demonstrating a significant positive increase in radiation-induced genetic damage in the offspring of exposed parent.i..

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..p e 1 I Below Regulatory Concern Policy Objectives a & y ;w J eex+4u@' l /To estabiha framework for future rulemaking and licensing decisions {xemp - ce activi ~ invo ving radioactive ~ Isp f p F material fro eg ry con on th asis) hat t are so small t furth forts reduce 1he are nur fp f [ warranted [- l/j r /To focus the resources of the NRC, Agreement States and j [ licenseesfjowafd a ssi I ~ _ yenijfic npisksirom { r j radiopettile rials nder NP.CT jurisdictionM i i s

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t i 1 l Below Regulatory Corcern Policy l perspective g-p/ Quantitative ris G e /The Commission d r.;*dsi dg(UNSCEAR 1988) and [T 4 one 0penaiefby the Uniht=tions 1 perfor:r.;d%y the National Academy of Sciences (BEIR V), -in e-*3mthg the rk's fi.: = icci :. b of redhtbn A v k /Thgcted fa relating fatal cancer risk to dose is 4,g talenYoe o x 10 per rem i j i /bsing iiils riA con.22:!:-n "re*c-he 10 mrem individual l dose criterion corresponds to an annual risk of fatality for an indkidual of 1 in 200,000, and the 1 mrem criterion to a risk of 1 in 2 million i t i /The collective dose criterion of 1000 person-rem corresponds [ to,== aanse; rbkeffatality of 0.5for each exempted prs.ctice per r l i l l V en W l eM Q <><K k., N.< gy I eetl f<.< a [ y lCLt Cr,brk ? e ., ~.

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