ML20128H156

Ack Receipt of Telcon Re Health Effects of low-levels of Ionizing Radiation

ML20128H156
Person / Time
Issue date:	05/18/1996
From:	Powers D NRC
To:	Roxanne Summers NRC
Shared Package
ML20128H116	List: ML20128H113 ML20128H156 ML20128H323 ML20128H429
References
ACRS-GENERAL, NACNUCLE, NUDOCS 9610090253
Download: ML20128H156 (10)

Text

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.05 18 96 14: 2* FLt 3055210245 g,m i

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i To: Roxanne Sumrners '

\a Ca. . ad e

} From Dana A. Powers 4

{ Subject HE.-u.TH EFFECTS OF LOW-LEVELS OF IONIZING RADIATION 1

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1 Many Wanks for se conference phone call on Friday and the revisions proposed by Shack and Kress to the draft letter on low-:evels ofionizing radiation. Both has e clarified much

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about the in:ention of the draf: letter for me I regret that I have to be such a ' pain' on this maner which is appa ently far more transpa ent to other members of the Join: Subcommittee than it is to

! me.

b Tne revised :etter does not rea'ly address my original points that:

- radiation damage is more complicated San a simple dose response relationship, i

- if we are to recommend in this area. our recommendation should address the broad range ofissues at stake raser than focusing on one narrow controsersial i topic, and l - it is unlikely that findings of unilateral examinations could be translated in

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revisions of the existing regulations. '

! But. I accept the idea at least in principle that a piecemeal approach to the subject m'ay be j appropriate. I feel, however, that the current draft lecer does not accurately state te poin:s and i recommendations tha: Ge Joint Subcommi: tee wants ACRS and ACNW :o endorse. Let me j make some specific comments about de le:ter including editorial comments and perhaps my I l concerns will become apparent:

i j - paragraph 1: With regard to the last sentence in this paragraph, I do not know $at the i Commission wants to review and analyze the issue at all. In fact, I think it emerges toward the l end of the letter that such a review and analysis is the actual recommendation Sat is 'emcg made

- paragraph 3

In the :ast sentence of this paragraph the issues at hand are related to te amphasis on risk informed regulation. We shou;d remember iat in adopting a stance insching

risk infornation the Commission did not abanden the concept of defense in-depth. Their supper-

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of risk-based regulation is no

especially strong as ref.ected by the " informed" term. In areas of great uncertaintv such as the ef#ects oflow -: eve'. dose response relauenships defense-in ders

. may be a more useful guiding princip:e :han ruk it is, in any case, not obvious to me that the l Comrnission must use its resources to address de :ssue. Cannot an applica".: propose rulemab.

and defend a position seeking relief som b rden of the linear hypoiesis?

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PDR GENERAL ACRS PDR

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- paragraph % line 6: " . ..independen: ar.d special tech ucal insestigation.. "

The lener does not indica

e wha: Me study is :o be independent of 1: would appear from te

ener as now written that the SCRP study

s to do exactly wha: :s recuested. I now know

• hat it :s

$25 s ud.s and tose who will conduc:it sat se lener objects to. The reasons for such objections

! are not ever 5:ated Similarly. :ater in the paragraph a cali is made for impartial resicw The let:er

' does not say sat h is believed sat the proposed s:udy by NCRP w1!! no: provide such an impartial review. I now know da: iis is in fac: wha: is believed. The let er does no: sta: or defend iis view. so a reader may wel;:hink Mat se planned NCRP study is adequate. I

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- paragraph 5; line i I tink tis phrase should be reworded Such an obviously biased i

} phrase really detracts from a letter demanding an impartial examination of a subject.

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..any study to contribute to the testing of de model." I think what is meant here is

] ..results of any study being used to test the model."

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- paragraph 6: Do you really mean sa: no heahhy worker effect was detec:ed in the- ,

l study? If so, I wou:d think it a very dubious s udy indeed. Perhaps what is meant is tat the I l 1

invesugators were able to correct for the healthy worker effect 1

- paragraph 6 -last sen

ence: This sounds remarkably like Lamarckian biology. l i

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-parag aph 7: Why isn': the quo:e the ;as: word on te subject? I prestigious group of

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exper:s has examined the data and hypoteses and published a conclusion it can defend. I know l

} the suiors of the tener don't dink a full examination of the available data was conducted in an unbiased manner. But, the letter does not say this nor does it say why the expens are be:ies ed to 3 be such bad guys This leads me to think the auiors just don't like the conclusion and they want to stack te supreme cour: with inexperienced people until they can get a vote that goes their w av.

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! - paragraph 8: last sentence on page 4 i

The logic may not be correct but :he conclusion may not be wrong. You are making a cost

) argument here and you don't present a basis for conclusion. Is it going to be cost-effective to go j the route you plan? I thmk the proposed study is a waste of money because it can't result in the l change of regulations. I know te regulations are a pain in 2e neck to follow, but I do not know

, ina: Bey are especially expensive to follow, nor do I Know that implementing changes with te l heag costs ohn:rahung will be cheap. Ought we have something akin to a regulatory analysis to j suppor: our posi: ion?

1 - paragraph 8 on page 5:

! Again, I ca'l your attention :o te fact that risk is not de only or even ie most importan: basis

for regula

ion The curen: approach can be defended on the basis of defense in-depthjust as j many other regu'a:ory positions a e defended i

i paragraph 8 last line on page 5 i  ! beliese this is We res! recommendation - re eumne the regu ato y model.

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e 0 05 15 Os 14 2" F G 50502:0243 3m

- paragraph 10 " ..crea:e an mdependen: Sedy ' Wnat is this' A e we recoc rnending te creanon of a whole new commission'In the cu ren: Sudgeta_? environment you wi:1 get ~

now here w,& this. I thmk tere is an Execu:S e Order ia: now :imits the creation of mdependen-eedies I stW. do no: see wni the NCRP s udy : anno: be counted en to do evervhing 63: i<

r: ques:ed :n tne !ener In fact. they seem to h.n e done it based on the quote cader :n the Ie: er :f new esidence has,iust recently come :o light sey may wan: o re-evaluate ieir posit.on paragraph 10 on page 6: line5 6 The sentence seems to imply Wat anyone with an expenise in dose response relatienships :s :pso fac:o biased. I for one cannot say this is accura:e I do not know how you abjudicate between the supposed biases and we:1 founded. tirmi> held , defensib:e positions. The addi iona: expenise being proposed here needs :o be bener defended so it is not attacked as "coun s:acking " Is it . .n fact. true tha: past examma: ions of te data did not include assessrnents ofie data quality'I wou:d be stunned if tis were the case. I: seems to me that all these studies get s: ruth:ized in g ea: detail for errors in design and 5:atistical analysis.

- paragraph 11 point (a):

This recommendation seems :o say put any old s: ray dog on We panel as long as he can c: aim to not have any expenise in dose-response re:ationships" I might take it also :o mean iat anyone who advocates LNT must be exc:uded as we:1. As :o point (b), is it true that tere was no expenise in s:stisdes among those involved in past exa .inations of the issue? I would be surprised.

- paragraph 1: " .iese studies. " Is iere to be more than one study?

paragraph 6: I believe 1e anecdotal ct:stion of a few studies is inconsisten: with a ca:1

o exa.nme all the data. Funbermore, ci:adon of the particular s:udies may make ie readers itri a bias e.usts among te autors of the let er.

I hope my cornmen:s are of some use in developmg a lener that can be tinalized. I regret 6at ngh: now I don': :hin'< I can formula:e specift: language on te issue because I'm jus: not persuaded of the draft position. Even ifie posi: ion is entirely correct, I'm not sure its wonhwhile to try to remedy the si:uation :his way

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PRX COVER SHEET

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PRIORITY: HIGH 14CZJt6 ROUTINE DATE 5/18/96 TIME: 10:41 PM PAGES INCLUDING COVER:

TO: B. John Garrick @ FAX 714 833 2085 Noel Dudley @ FAX 301415 5589 cc: Roxanne Summers FROM: MARTIN J. S'lENDLER 0 Phone ( H) 708 2413750+

Phone (O) 708 252 4314 .

Fax (O) 708 252 5528 FAX.....(H) 708 241 3750-NESSAGE:

Noel, John; Regarding version ' Final Draft 18, 5< 17. 96' of the Health Fffects letter faxed to me by Noel, please note the following.

1. Page 4. perhaps the terms logic' might be better ' conclusion'. The softening of the sentence is ok but there is a loss of punch'.

2. Page 5,1st full para.: I don't understand why ' scientifically-based' has .

been removed. The term ' appropriate' could ven well refer to one that is '

incorrect but conservative, which is exactly what we now have and want to reexamine. I urge retention of what was there but I won't object absolutely if this is all that stands in the way of getting the lener out.

The rest of the changes are ok but strike me as not substantiw. I urge that any future messages be handled in accord with information left with Rich

.\lajor or John Garrick, regarding where and how I can be reached.

605:5-3450. F.w nurnber .s ?.c 5xnc 4 Addms is . 52a Cb;s;;o Ave Downers Orme il as the phone number.

= No unattended reception. Call and talk to us before sending.

... :.-r - s : 2tm24. : ,re: L :a, va :- 2 w e a:v :3;. e 2 3i2a:9i FAX O John La k r.s CC O AC AS/4 CNW Joint Succormittee Members ijTL - please p owce Ocpies of t,is nemo to the members)

Roxarne Sumrrers FROM JCC SUB.ECT 3/26,96 ACRS/ACNW Joint Subcomrittee Mee:ing Secause of another comnitnent have decidec to conserve you" bJdget oy 1 not at:encng the 3/26/96 AC:lS/ACNW Jo n: Subcommittee Mee:ing Add tiona ly as a shor: t mer c, AC AS (my te m ends on 5/30/95) I we, t be arCJrd to carticipate in the on-gong del be#ations of low-lev e rac atior mealt, effects a sLbject dea" to rry neart I have f all -

con' dence that be n'embe's of t,e .cint Succonm ttee w I! Ocme to an  !

appropriate pas tion on ths issJe Witb oLt my preserce at the neeting i I have reviewed the mpressive stac< of paper on low-le vel rad a: ion health effects that Roxanne put together fcr be meet ng I bei eve now I as have believec for the 40+ years that have Deen associated with the nuclear power ndust :nat the nLclear es:ablishment has created a, unwarrantec fea" of man made ionizing radiaticn on tne part of the.

general DLblic with the 'Inear. no threshc d" effects / dose hycothesis T,is nas "esultec in a tremendous f nancial and health effec:s cost to society not cnly w:th "espect to the utilization of ruclear pcwer bu: in the use of all forms of nJclear te:hnology T,ere apoears to be considerable technical bases for tne March.1995 Hea:h Phys::s Society's reccmmendatior "

agairst quan:itative estima:ior of health risk belcw an irdiv dual dose of 5 rem n are year :-

a li'e:ime dose of 10 rem in acditior :o background adiation " Hcwe.e*

tre procenents o' t,is cos. tion we e given a numcer cf clearly va id challenges by W K Snclair (See p 5 o' Attac,n'ent 15 te Roxanne's rem:

Of his severa quest ons. was pa'ticularly ntrigaed by h.s question regarcing tre ;sef alness of a threshoic of a very Icw valte o' case .,

actLal radiat on protect on practice I believe t,at we have an answe ::

this cha lerge as it concerns :he rega!ation of nJclea power plan:s T,e last 1 of Ma"v Goldman's con mer:s ,see At:ac,nent S te Ac.an - s rremo, seem to me to be an espe: aJ., :: gent summary of where ^e a e anc where we shculd De going

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'Let s stop deba.ing wha we believe and hope for and put t ie lirear rc-threshoic hypothesis to sound sol d scien:ific scruttry an::

at ec ..e testir g It's time fcr inr'ovative esearch I We need to dc a corplete review of the avai ab e da:a and as well employ our ne.ve-molecular tools in un que resea c, :c better understanc the rac axn carcinogenis s process' I don t believe tna* :he NRC can change its regulatory aoproacq (at east poh:ically f r o: ega ly: until the NCPP (ard tne ICRP9 changes its racia:icn p otection phi osophy wit, resoect to Icw doses of adiattor Attachment 24 to Foxanre's merro is a croposal to :he NRC frcn the NC AP datec 2/1Ci95 :over a year agc) to produce a report er itled " Critical Evaluat on of :he Linear 4o t,resho c Assumptions " The est r ated cost of this three year study is $225k a drop in tne bJCket relative to the AE S j bucge: We need to know what ac:icq has been taken by tne staff with regard to t,is p*oposa- t seems te me that tnis is an obvious ' st steo

, in dealing with :his issue although I can imagine that there are staff pecole : hat m gnt see this as a threat :o their empires Finally I believe that the Corrm.: tees eith e- indiv:dtal:y c lointly should recommenc to the Commissicn that the agency cevelco a proactive' j st ategy to settle the question of the health effects of low level radiatic, exposure Th s weJld be wholly ccqs sten: with this Commission's state- j policy that NPC egulations should be risk inferned l 4

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BEIR VII " SCOPING' STUDY" l

Draft Work Scope May 2, 1996 E aGRC.'C Since publication of the 1990 BEIR V Committee report. "Healin Effee.;

of Exposure to low Levels of lonizing Radiation." new information has beccre avail able e&the Japanese-atest--bore-wrv4 vers and etAer-regarding cohe t s exposed to ionizing radiation at low doses and dose rates. Studies at the molecular and cellular level have poMed-de-way-4owards--contributed to a better understanding of carcinogenesis and may eventually lead to an imer:,e:

basis for estimating radiation risks at low doses and dose rates. In addition, there is new information on the effects of low-level radiation in producing risk decrements of both mortality and cancer, and other non-cancer effects ather thar caneer.

To be credible, it is critical that federal radiation protection ,

measures and risk assessments be based on the best current science. Altnough the emergence of new epidemiological data and progress in understanding tne biological basis for carcinogenesis is expected to continue in coming years an update-extension of BEIR V may be desirable at this time. Before proceeding with a full-scale National Academy (BEIR VII) review and analysis aimed at updating the existing state of understanding and quantification :f risks from low dose, low-LET radiation, it would be advantageous to concuc a '

preliminary study that would examine the range of potential issues that ::e :

be addressed, along with an assessment of the usefulness of available source; of new information in order to define the most useful scope for BEIR Vll.

PROPOSED PLAN Of ACTION l

The Board on Radiation Effects Research will organize a small expert panel to investigate what issues a BEIR Vll study might usefully address in depth. The scoping study should address each of the issues / areas outlined below and anj others the panel deems relevant. In conducting its review, tr+

panel anculd consider the current availability of data not evaluated by *.he BEIR V committee and the expectation of significant additional data during tne period of the BEIR Vll review. The panel should provide a final letter repor*

that: (1) recommends which of these issues could profitably be addresse: in decin :n a BEIR VII study (2) provides a basis for these recommendations. 3 lists ;;rtmary sources of data that might be used, (4) assesses whether or nc*

a detat'ed analysis of each issue could have a significant effect on the quan*. h cation or validity of radiation risk estimates, and (5) indicates < v l scientif'c disciplines would be required to adequately address each of *.ne- j i

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OUTL!NE OF 20E 5 'O EE 2EE:E55E: : 'e 3 . ~ ' : '6 5 ~ .C r In 'r 3 ' : ng 's ne: 3 r e # n ; , e d i r. Gtare BEIR stuctes. *ne . v-

nou'1 a* ';;;* a. ;w *re Oqw 'u:

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ss e s t ' m a *. i ' ' 2 n ii -s 20;e; The form of the low dose response se'ow in the dose range direct;,

accessible to human epidentological studies, including the evidence # y or against linearity a n d t h r e s h o l d s at --e r-rear 4ae kgr o u n d ! c esb of e*posur-e Adjustments to organ-specif'c risk estimates at low dose rates, e.g. -

expressed by a Dose Rate Effectiveness Factor (DREF)

Signi ficance-or non signi ficance- of "hormetic ef fects." i .e. , risk decrements in human populations resulting from enhanced prevention, repair, or removal of DNA damage in the exposed biosystem. (e.g.

adapt he-responser-im,u r + +fs4*+4-W eMor+-ts-he-dose-respow-Ju (4aeer_+nduc44en

2. Numerical risk estimation Alternative biologically based models for projecting radiation-induce:

cancer risks in the U.S. population. for workers and the general population Quantification of uncertainties in radiation risk estimates Resolution of claimed inconsistencies in risk estimates derived from different epidemiological studies 4

UNSCEAR 1994 Annex B contains a discussion of various mechanisms for adaptive responses, such as, prevention by increased radical detoxification (page 205), repair by activated genes and their enzyme products (page 199).

removal by apoptosis (pages 199. 208), and immune system changes (page 206).

The following biologically based models include both the normal very high background of intrinsic metabolic mutations (2.4x10'/ cell / day) and the adaptive responses of the biosystem to radi; tion.

e A Cytodynamic Two-Stage Model that Predicts Radon Hormesis (Decreased, then increased Lung-Cancer Risk vs. Exposure. Dr.

Kenneth T. Bogen, Lawrence Livermore National Laboratory, University of California, February,1996 e The meaning of the a-Term in the Dose-Risk Function for Late Radiation Effects, Ludwig E. Feinendegen. Medical Department, Brookhaven National Laboratory. Upton, NY, and US Department ;f Energy, Washington, DC

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rena'al +<pcs ,c+3 In 'e/'+ wing these and otner

s;oe: the sources of Ja.a :;r  :,- .  ;

ihould tr:lude (but not be lim;ted to) ine follow:ng:

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e Japanese ato :c boTD sure1/ ors data Cancer incidence and mortalit / data availaDie suoseauen* *: EE:; V analjsts with emphasis on exp'osures at low doses and dose rates Depen.jence of risk on cancer site. age at exposure, age at ot;er.a*, ~-

time since exposure, gender, city. and dose New Jos'Te'.ric information, particJlarlf pertaining to neu'. con OC;e; a*

Hiroshima Gn risk Estimates. applicable to elevated environmental ergasures

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Evidence pertaining to possible low level radiation induct'on .'

noncancer ef fects ( mortality, genetic teratological . cardiava. ..

atarac t s. etc. ) t+r444La44sn e Otner epidem:ological low level data that has been cited as a Da; 3 *:- I l

c';( esti at'3n at low levels of eAposure l

l Me0 ' ; 3' j 1rradiated Cohorts D00L'a*'ons exposed to chronic doses: (1) groups exposed in tne 3:< e<

sc. c*. .rt:n. (2) nuclear workers in the U.S. and other countr +;. i" :

:*aer ;opulation groups for which studies nave been repor*.e: +.;.

<e. erta of high background areas).

. ;ence #;r carcinogenicity of I-131 e c;ra*;<. A udies certaining to mechanisms of radiation carc'r:;e e-

< e : -: 2' /arious types of CNS damage produced by radiation and

ntr'rsic normal metabolism.

E '  : - . ;f biosystem in prevention, repair, and removal of DNA r L and *s functional dependence on dose and dose rate

cc *a ce of soectc aene :aar;;; ca; sed by radiat an De X+-

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If- 00531016. Ind1C3ts an3* 3dd't.1,0ral data wou? 1 be 9990ed i

1n 0'J . 0. *.C -3*4 JuCF 39 OValuat100 appropriate.

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