ML20129J376
| ML20129J376 | |
| Person / Time | |
|---|---|
| Issue date: | 05/15/1978 |
| From: | Parsont M NRC OFFICE OF STANDARDS DEVELOPMENT |
| To: | Kastner J NRC OFFICE OF STANDARDS DEVELOPMENT |
| Shared Package | |
| ML20129J281 | List: |
| References | |
| FOIA-85-309 NUDOCS 8507220551 | |
| Download: ML20129J376 (8) | |
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UNITED STATES
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MAY 151973 MEMORANDUM FOR: Jacob Kastner, Chief Environmental Standards Branch, SD FROM: Michael Parsont Environmental Standards Branch, SD
SUBJECT:
TRANSMITTAL OF STAFF COMMITTEE EVALUATION OF THE FINAL REPORT #13 SUBMITTED BY THOMAS F. MANCUS0, M.D.
The staff committee (M. Parsont, ESB, S. Yaniv, SAFER, and D. Rubinstein, ED0) has completed its evaluation of the above subject document. A copy of this evaluation is attached.
Final Report #13 contains the analyses of the Hanford Occupational Mortality experience as analyzed by Dr. T. Mancuso, A. Stewart, and Mr. G. Kneale.
The analysis is the same as published in the November 1977 issue of Health Physics.
AW6!{$%f 4 Michael Parsont Environmental Standards Branch Office of Standards Development
Attachment:
As Stated l
8507220551 850524 PDR AhAR 85-309 i
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THE 5 AF: C::MMITTEE 57ALUATICit CF HE .:INAL RS.00Rf p13 SUSML ag 3y THCMAS .:. MANCUSG,. M.J.
Int eductfort Orr October i3,.1976, Ors. Thomas Mancuse, Alice Stawar and Mr. George Kneale presented a. paper (hereafter caIIed de "Sarat:ga Scrings paper") at
- a. Health Physics. Scciety Symccsium in Sarat:ga Springs, New York.L The authors purportai 2 demcnstrata a; causai and numerica! relaticnshia between low- level radiation and de acr:ali y frc::r cancar irt fcr :er encicyees of the Hanford Labcratories of Richlanc, '4asning :n.
The authors rescriad an acparent asscciatica between de :recer.icrr of specific cancar morniities and the amount. of cc::caticnai Ndia:icrr ex:c-sure received. The authors. claimed 2e resuits incicatad a much more ~
prencunced radia-icrr effect tharr had been =ncluded f em ;revicus studies in man and laborat:ry animals. If valid, he findings cf dese analyses wcuid. indicata significant imolicaticas for cur assessmen Of radiaticn effect crr da health and. Iafety Of tne ;uclic. his. accites not aniy ::
NRC-Ticansac ac-ivi ias, bu aisc to other radiaticn ex:csure scurcas such as natural background radiation and mecical X-rays. herefore, a technical c:mmittae was established ta study de "Sarat:ga Springs ?acer d t: provide tachnicai fudgments of t s analyser and : nclusiens. "The Saran ga Springs Pacer
- was reviewed for c:=perancs of achnicai c:ntant, presentaticn and analyticar tachnicues, and the staff =mminae rescr.ad its findings in Novemcer ig761 Dr Novemcer, igF,. Dr. Mancusa. sucmittad . ina.i Recor- p12 = 5ROA.3 inc published in da Heait.4 ?hysics JcurnaI' -hat ;cr icn of =a tax: which representad a reenaiysis of the Hanfcrd cc==aticnai mcrulity ex:erience.
Cr A. Stawar; and Mr. G. Xnee.ie per# rned de analyses with Dr. Mancusc for tha . inai Repcr anc c:aut:cred de Meait ?hysics Jcurna! article.
The staff c:mittee was recailed 2 evaluate =e . inal Repcr . Tha; evaiuaticn is the sub,iece of this paper.
The originai data. used by Mancusa et ai.. mere act avaliabia = us, and.
attamats tc catain desa da:a were noe suecassfu.i. ineref:re, the eva.sua-
-ferr had ta be based Orr de sumary tabies. and grachs as given irr :he presentat.ica by Mancusa et aI.
since: de "Sarat:ga Iprings Facer", dere have been numerous versions and adcenda On me same sucject by Mancuso, Stawar . and Xnea.ie as well as ; apers by c:her auchcrr. '4hite we wcuid have itked i atucy ali relevant analyser, we were nec able = ;er' ra =m recensive reviews :f ali pertinen ;acers.
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4 Committee Findincs
- The Committee findings *are summarized belcw:
-1. Subject to the caveats indicated in itams 2-8 some of the author's tabulations were suggestive of the existence of excess cancer mortality among exposed Hanford employees larger than could have been predicted by other publications.5>S *7.3
- 2. The authors dealt with potentially confounding factors one or two at a time ignoring the comolex interrelationships among factors. Confounding of cumulative radiation dose with age, calendar year and time of enployment are particularly pronounced. In addition, medical radiation, demographic and other factors may have further confounded the analysis.
- 3. Small sample sizes, especially encountered in the analysis for specific cancer types, can be misleading. Particularly in the comparison of mean cumulative doses of small samples, the averages may be dcminated by the exceptionally large doses to a few individuals.
- 4. The authors' presentation of doubling doses (ranging from 0.1 rads to infinity and varying drastically with age) is bizarre. In order to accept doubling doses as low as 6 rads one would have to attribute all " spontaneous cancers to natural background radiation.
- 5. In several instances the authors';conclusicns cannot be sup-parted by either their analysis er their presented data.
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- 6. There are instances in which tabular material presented allows for multiple interpretation of the data.
- 7. The authors dic not ooserve an increased leukemia mortality, which is the most readily observed radiation induced malignancy.
. 8. The use of a prospective approach to the epidemiological analysis would have been superior to the retrospective one taken by the authors. -
A View of the Literature In the committee review of the "Saratega Scrings paper", reference was made to several refutations of the analysis by Mancuso et al. Since that time
- additional analyses have been made both on the cublications of Mancuso et-
"One of us presents additional personal review in Attichment 1 2
aT.,. and of de Hanford nor*aif ty dan demselves. AIT of these analysas '
agree. ta scme extant wi2 de-::nciuriens :f the suff c nnittae. The 1ataments beicn are sacr: paraphrasas of ne autncrs' c:nclusicas Dr. CharTes Land of de Nationai Cancer bstituta analy:ad Hanf rd Moruif ty Catz which was similar tc. de dats- analyted by Mancusc a: 11 .3 There were differences in the data bases because Dr Mancuso refused ta suppiy to others additionai. datz which he used Land fcund excesses of multipie myeicma and pancreatic. cancar. However,, he stated "...the data suggest that cne of the two cancers,. but not necessarily both, may be associatad with dosa.
The associatica is not necessariTy causai, in 2e sensa 'bac both dose and the cancer c:uid be causally asscciatad wi2 a; third vaMable, but not with each other.* In additton, Land suced 2a: de ::nclusiens by Mancuso et ar. about variaticns in sensitivity tc radiation by age at exposure appear to be untanable aithough the existance cf a t ue radiation-induced excess cannot be ruled cut withcut furder analysis. He suggestad that a c:hort anaiysis of the Hanford ex:eMence wcuid be a great imprevemen cver de proportionaT rartality anaiysis.
Dr. Daniai Xiei'=an, an a:piied sutistician 1: MI.T and an NRC c:nsuitant,.
per'crmed an independent anaiysis Of de final repar .M His principie.
findings were dat 1) ncne of de c:nclusicns by Mancusa at ai., ars justi-fied by their data analysis,. 2) na effort is mace t: c:nsider .ne effects.
of other potentiaily carcincgenic agents,. 3) a za.icrity of the c:nciusions by- Mancusa et ar. art based en signe cases of ruitiple myeicma, and whtTe tnesa casar deserie investiga:icn,. in .he ::n ax: cf what is kncwn abcus the acidemioicgy cf multipia myeicma,. dey art insufficien to supccr
.hef r c:nciusicn., and 1) na effor: is made :: assess -he validity of de ifnear modeis usad cr := cb: sin c:nfidence in:ariais en de dcubiing- deser.
Gr. Earkey Sanders, who workad wit.t Cr. Mancusc cn de Heaith and Mor ality Stucy,. per ~ r:ed. art independent anaiysis of te Hanford Mer aiity dan.
His analysis wiii be puolished in de Health Physics Jcurnal.-- !anders c:nc!uded. that thers was na indicarica ta: radia:icn caused de Observec.
scmewhat higher prcpertien af cancar deads accng maia Hanf:rc ac:Icyees, as c:meared = cales in the gener'.i ;ccuiaticn :f de sta:e of Washingt:n in addition,. Sandars ccmcared icngevi y of ax:csad Hanford emaicyees witt a.c:ntrei greuc cf their siblings and found higher icngevity in de aciayee.;ccuiation He nunc. riss nac expcsed smoloyees nave higher i icngevity than nonexposed wrkar and matened centr:Ts, and .has ncnex:csed.
I spicyees have. icwer icngevity can deir sibifngs and ma::ned c:ntrois.
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Mcwever,. he did no icek 1 specific cancar types. Sancers aisc c:ncluded tnar radiation shcuid not be eiiminated as having played at least a c:ntHbut:r' fur ner ccs aria-icns may indicata- a measurabia adversa affect.e He reia.
risc in arcincg
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called at antion ta uncertainties, in dosimetry and de ;cssibility that other carcinogenic agents may have ac ad. synergistically with ndiarien-s causa cancar.
Cr., L. A. Sagan, Electric ?cwer Research Insti uta, quesdened the finai reper: irt the areas of Ocse .stimates. and. MathedcIcgy. ':- De major trusts of' his anaTysis were based art I) the skewness cf the desa dist-ibudon in which the average deses were- dcminated. by a s=ati number of high doses, 2) the Tack cf consideration of ac: ai radiaticn execsures received by Hanford empicyees siter pricr or subsecuent to their Hanford. emolcyment,
- 3) the lack of consideratierr cf~ cther ;cssibia variabies which may have influenced de risk of cancar and '-) the use cf a. preccrtionai Icrtality approach.
yv Marks et aT., perforned a echcr ,. or peculatica basa study, of the Hanford Mor ality Data.'.2 Tnis included examination of the health experienca of scme 29,C00 Hanford empicyees. They cbserved an increase in multi 2Te myeicma. and pancreatic cancars as did both: Land and Mancusa et al. ~
Mcwever, because. increases in diseases more c:rancrriy asscciatad wit.'r ndiatica wers not coserved dey did not c:nsider de resuit: .c be definidve. In additien, they f:und nc cther significant inc sase in mor.a.Tity cver ncrmal' expec adens for ali causes,. ali cancar types and.
remaining s:ecific cancer ypes. They c nciuced da: 2eir anaiysis showed a
- healthy worker affect" - cat. being a recuctica irr the standardi:ed acrtaif y rade -(SMR), wnich is coserved frecuan:Ty irt -he casa of workers irr incustries free c'f sericur Tife threa:aning ha:ards.
Thersfere, One IMRs ars Tikeiy :: be- higner for cancar dan for most c:her diseases because the fac*crs res;cnsibia for 2is effect are Tess likely to be effective fcrmcs: cancar types darr f:r other causas of deatn. T*1fs. differential ef"ec wcuid cand :: biar precor-icnai mortari.y anaiysas,, sucir as perfor :ed by Mancusc et 17.,. t: ward falseiy indicating art excass of cancar.
Dr Truirr 0 d 3ross,. Jr., has incicated arr increased effec: cf icw Tevei icni:ing radiatien (i:r :ne range of d:sas frem- ICC mrads :: 10 rads, wnich he calis de 1 rad range).3 3ress c:ncluded ca: his rssuits are su; cr:ad by thosa of Mancusa er ai. 3ress examinec. Ieuksia irt ex:csad adul .s,. irr caiidren ex;csed irr utare anc. irt de offspring of parents wac wers ex;csad aither singTy- or both cc preconcapricrr radiatictr.
Retsla65 aisc found in accarsn increase in- de incidence :f ieukemia.
among early en: rants tc Hf r:shima felicwing da at:mic bem: excicsien.
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Sumarr of Ccnclusions-
.I. 'Je belfeve da: 2e- FinaT Raccr_ cannot be c:nsicered as a definitive stucy because:
(a) There is ccnf unding among relavant fact:rs.
(b) The retrospective anaiysis, ccnfined to workers dying before 1977, igncres the dist:-ibutfort of radiation deses ascng. the surviving Hanferd empicyees.
(,c) Muc.'r of the analysis is cuesticnabTe,. deficient and amoiquous.
- 2. Subject Odine above- cavea:s we find dat scme tabulations and analysas of the Final Reper: are suggestive of a radiatien effect mars pr ncunced
- harr previousTy thcugnt.
- 3. The cemit ee repeats te: rec mendatien cf its previcus mcor9 that a painstaking analysis cf the relationsnip Of cancer- ::: Icw level radiatio:t is of u=ost im:ar ance. Such an analysis should be a weil c::ntroiTed prospective type stucy en as. Targe as feasible sampie:;;f occu:acicnally ex;:csed. vorters.
This. stucy wiii he Of particular impor:2nce. :c 'GC because it is most.ccnducive tc. narMwing de uncer ainty irr risk. esti=aas fr nt excesurs :: Icw TeveT icnizing radiatica,. and :: providing a mers solid. basis. for standard set-ing.
O
9e REFERENCES I. Mancuse,. T. . . A. M. S tawarr,. G. 'A Kneaie. 'Radiatien hpcsures of Hanford '4crkers Cying fr:m VaHcus Causes.* ERDA Cen:rac: No. E(li.7) 3423 presented at the Tenth Midyear Sympcsium of -he Heal:.4 Physicz Society,. Saratsga. Springs,. New York,. Oc :bar 11-13,.1975.
2'. Parsant,, .V. 5 Yaniv,. D. Rubinstein,. A. 3redsky. "Reper: cf *he Jtaff Ccmittee to. study 'he paper Radiaticn Sposures of Hanford '4crkers Oying frem Various Causes.* U.S.M.R.C. Novemcer 1976.
J. Mancuse,. T. .:. " Study of the Lifeti;te Health and .tr.aitt/ hperience-of Emcicyees of ERCA Centrac.:rs. Finai Recer 113.'
1 ERDA Centrac:
No. E(-76-5-GZ-3423. Septamcer i977.
1 Mancuse,. T. . ., L Itawar ,. G'. Kneaie. Radia:1ctr hpcsures of Hanford
'4crkers Oying frem Cancer and Other Causes. Heal:.t Physics 23:.5:265-38E, 1977.
- 5. ICRP ?ubitcarica 25. Recomenda:icns of tne internadcnai C:rmtissicrr crr Radicicgicar ?rc:acticn January 1977.
6 A Repor of the Uni:ad Nations. Scientific Cemit as en .he- Effec s of At:mic Radiadcrr. "!cnizing Radiaticn: Levels anc Effec s United Nadens, New Ycrk,.1972.
T.,
Unitad Naticns Sciendffc- Cernni'tae cr the Effec 2 cf At:mic Radiatictr.
- Sourcas: and. Effec s cf cnizins Radi2:icrr. L'nitac Nadens, New York.
1977.
F Reper: cf -he Adviscry Cemit ae crr 'ne Sicicgical E"ects :f .cni:ing Radia:icnr.. Tne Effects of ?ccuiations of L;:csure t: L:w Leveis Of Icnizing Rad.iatiert. Nacicnai Academy of Sciences - Na:1cnai Research Ccuncil, 'Jasnington,. 0.0. 1972.~
- 7. Perscnai Comunica:i~cn,. Charies I. Land, Ph.2. .: Cr. Michaei A. ?arsen:.
- Review cf Mancusc,. Stawar , anc Kneala: Raciatien Spesures of Hanford
'4crkers Oying Fr ::r Cancar and Other Causes.* March 3,.'978.
- 70. ?srscna.T Cerr:unicattert, Canfer 1. Xieit::arr .: Jacob Xas:ner. "CMdcue of MSX. Repert. ' March 2,1975.
IT. Sanders,. 3. T. L:w-Laver Radia:icrr and Cancar Ceatns. Ac:ac ad f:r publ.icaticrr in Heai.h Physics.. Septamcer 15 1977.
T2. Tagarr,. L. A 'Lcw Lever Radfaticn Effects: he Mancusc Study. '
Electric Pcwer Researt:r insd .ua. ? sic Aite,. California.
REFERENCES (cent'd)
- 13. Marks, S., E. I. Itiber , 3. D. 3reitanstein. ' Cancer Mar 211 y in Hanford '4crkers" ;resantad at the Intarnaticnai Symcostunt en the Lata 31olcgical Effec.: cf Icnt:ing Radiation. 'ltenna, Austria, Marc.'r 13-17,.1973.
- 14. Eross, T. G. J., Jr. " Hazards t: Persons E.x;csad :: Icnizing Radiation (And To Their Children) Frcm Cosages Currently Per ni tad by the ttucTear Regulatory Comissien,' resented it an NRC sponscred Public. Meeting, '4 ashing .:n, 0.C. Acrii T, 1978.
- 15. Rotblat, J.,. Risk Fac:cr for Radia:1cn incuced Laukemia. An:eng Entran's te Hiroshima. Tp be published in ffature.
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