ML20133C758

Responds to Chilk 780227 Memo to RB Minogue Requesting That Commission Be Informed of NRC Activities & Position Concerning Brodsky Recommendations Proposing Increased NRC Involvement & in-house Capability in Radiation Research

ML20133C758
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Issue date:	04/07/1978
From:	Minogue R NRC OFFICE OF STANDARDS DEVELOPMENT
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ML20133C731	List: IA-85-309, Draft Commission Paper Re Status of Ongoing Staff Work Concerning Mancuso Study & Response to Senator Brooke Questions on Study ML20133C729 ML20133C742 ML20133C758
References
FOIA-85-309, TASK-IR, TASK-SE SECY-78-197, NUDOCS 8507200563
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{{#Wiki_filter:_. s - a utilTED STATES . C'f,< 3-19,e 5[ NUC1. EAR REGULATORY CCMMISSION Aaril 7' 1973 g W ASHIPvGTON. O. C. 205$5 INFORMAT10N REPORT 7 ez 4 ?cr: Ine Cami ssioners from: A. 3. Minogue, Direct:r, Orrice er stancards Jeveicpment t N i Thru: /. L. V. Gossick, Executive Director for Cperations ( r - Suoject: STAFF RESPONSE AND POSITION REGARDING OR. ALLEN SRCOSX't

• 5 RECCMMENDAT!ONS ON JA0!ATION HEALTH RESEARCH vurcose:

To respond to the Samuel S. Chilk 2/27/75 memo to Accer: 3. Minogue, requesting that the Ccmmission be informed regarcing NRC staff activities and position with respect to Cr. 3recsxy's recomencations proposing an increased NRC involvement anc in-house capabfif ty in radiation epidemiology research and relatec activities. Discussion: In his January 12, 1973 memo to Dr. Xastner ecmenting en tne Septemoer 30, 1977 puolisnea version of the paper oy Mancuso, Stewart, and.<neale, Dr. Brocsxy mace four recem-menca tions. This pacer describes 50 actions anc positions nitn respect to eacn of the rec:mendations. The full text of Jr. 3rocsky's rec mencations wnten appear in Section III of nis memorancum (Enclosure 1), are summart:ec :elcw. This response has been :cortina ad with RES. In accition, cements on Dr. 3rodsxy's rec:mencations receivec f rom.1RR anc.9455 are included as Enclosures 2 and S. These ::ments are in accord witn tne 50 res;onse. Dr. Broasxy 's Reccmendatt on 1: The NRC should urgently initiata its own inaecencent evaluations of tne morulity experience of tne Hanfore worxer population. Staff Resconses: In Oct:cer 1975, Mancuso, Stewart, and .<neale mace a presentation on their analysis of cne hanford At:mic Wortcs occupational cortality excertenca aefore tne

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M. Earsont, 50 443-6900 8507200563 850611 PDR FOIA

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6 The Comissioners Health Physics Society.* Because of the controversial nature of this material, an NRC staff cemittee was established to study the HPS report to evaluate its methodology ana results and to recomend future NRC actions, if any. The comittee was composed of M. Parsont (Chairman), A. Brodsky, S. Yaniv, and D. Rubinstein. On November 16, 1976, the staff comittee issued its report (Enclosure 4). The consensus of the comittee was that the conclusions drawn by Mancuso et al. were not supporteo by the information presented in their document and that no imediate regulatory action was warranted. However, the comittee agreed that the total content and impact of the Hanford and other pertinent data should be stuoted and evaluated further. Thus, very soon after the HPS version was published, the staff recomended an independent evaluation of the Hanford occupational experience. Primary follow-up activities in this area are given below. In December 1976, an NRC-sponsored analysis of the Mancuso et al. finoings was undertaken by Dr. Daniel Klef tman, a consultant to the NRC Office of Standards Development, and an applieo statistician at MIT. Dr. Kleitman reviewed the HPS version of the Mancuso report as well as the draft revision and the final report. His conclusions were generally supportive of those of the staff comittee report on the HPS. The staff comittee is currently involved in its own analysis of the final Mancuso et al. report. This analysis will be available within two weeks of the date of this paper.

• Since October 1976, there have been four separate major presentations by Mancuso, et al. on the subject of Hanford mortal i ties. The first three of these analyses used identical data bases (Hanford Mortality experience from 1944-1973), but the analyses were refined in the later publications. The last analysis used an expanded data base (Hanford Mortality experience from 1944-1976) and still further refined analyses.

However, this last analysis did not significantly alter their conclusions. The first was a preliminary presentation in October 1976 before the Health Physics Society (hereafter called the HPS report); the second was a March 1977 draft revision of the HPS (hereafter called the draft revision); the thiro was a report published in November 1977 ano published in Health Physics (hereafter called the final report). Subsequent to tnese, in March 1978, a presentation of another analysis was made at an IAEA Symposium.

r .4 The Commissioners An effort to analyze the entire DOE occupational exposure data, only a portion of which was analyzed by Mancuso et al., was initiated in June 1977 with the forwarding of a Proposal Request Outline (PRO) to CRNL requesting that a Program Proposal (189) be submitted to NRC for an analysis of the Mortality Study data. ORNL submitted a 189 in July 1977, but DOE /ERDA management subsequently required that the proposal be modified to limit the ORNL analysis to the Hanford Mortality data. During discussions at Oak Ridge between representatives of ORNL and NRC (SD and RES) the 189 was rewritten to y limit the scope of effort to the analysis of Hanford Mortality data. By September 1977, there was a serious question as to whether ORNL was in a position to perform an independent analysis because of possible ERDA influence; therefore, the staff began considering other options. It was ultimately decided to issue a Request for Proposal (RFP) to have the Mancuso data analyzed by three to five independent scientists or organizations. The preparations for the RFP began with a letter to J. Liverman (D0E) requesting selected tapes of the Hanford study. The data contained on the tapes that will be obtained are very similar to, but not identical to the data analyzed by Mancuso et al. Several attempts were made to obtain the most recent data from Dr. Mancuso. These attempts included personal communications, telephone conversations and letters. Dr. Mancuso has refused to supply the data to the NRC. On March 22, 1978, the NRC Division of Contracts transmitted to the Commerce Business Daily the public announcement for the RFP. The opening and clrsing soli-citation dates are April 12, 1978 and May 12, 1978, respectively. ( A copy of the draft RFP is presented in Enclosure 5). Dr. Brodsky's Recommendation 2: The NRC should imediately initiate plans for a long-term prospective follow-up study of all employees monitored for radiation exposure in licensed nuclear power plants ultimately to include all licensee employees exposed to radiation. Staff Response: A long-term prospective follow-up study of NRC licensee occupational radiation exposure would provide some information for the evaluation of low level radiation health risks. However, this would utilize only part of a much larger booy of data, including licensees of other federal agencies as well as medical and military-related exposures. Dr. Brodsky's recomendation is well taken, but tne best possible large-scale radioepidemiological study should incluce these other sources of data.

-e The Commissioners There is some doubt whether even such a very broad study would provioe definitive answers because of the many variaoles and agents associated with the development of cancer. A large, properly conducted stucy of this type could provide additional information to provide a better basis for informed regulatory action. Such a study would at least provide the qualitative guidance that would arise from documenting the actual long-term health experience of radiation workers compared with the non-radiation worker population and other comparable populations of interest. If a major study of low-level health effects is to be conducted, extensive and careful planning of the study will be needed. Before a large study of many people is performed, a thorough study design should be prepared that carefully identifies and considers the various confounding factors. Appropriate agencies with radiation protection responsibilities should be involved in the design of such a study to see that their parti-cular neeos are met. Such a study will also require carefully selected control populations. To get such detailed information may involve invasion of privacy questions. The Public Health Service could help to explore some of the difficulties in performing studies of health effects among members of the public. To be most effective, a major study should include the largest feasible population of exposed persons and controls. Any effects which might result from low-level radiation are presumed to take many years to manifest themselves so that any study of currently 00 served effects must be based on doses received and measured many years ago. Occupationally exposed and monitored individuals are only now reaching the age at wnich large numbers of' deaths from all causes, including any premature deaths that might be due to radiation, are likely to occur. Thus, the mortality experience of occupationally t exposed persons will be available for study. The actual cay-to-day conduct of the study would most appropriately be performed by organizations with substantial experience in epidemiology. There are several federal agencies that have substantial responsibilities in radiation protection and would be the users of the results. All of these agencies including NRC should play a significant role in guiding the design and conduct of the study. I t

a The Commissioners Dr. Brodsky's Recommendation 3: The NRC should examine available metnocologies in radiation epidemiology and biostatistics to identify those most desirable for future application. Staff Response: Health-related studies presently carried out under NRC auspices are performed by experts under contract who do have access to the necessary epidemiological methodologies. Further, these methods are generally applicable in health related research not necessarily related to nuclear activities and are presently available from other agencies which use them on a regular basis. Finally, the proficiency of an agency such as NRC in helping to design and guide the conduct of a major epidemiological study does not rest upon the acquisition of epidemiological methods as suggested above. If, in the future, the role of NRC changes with respect to direct involvement in basic epidemiological research, implementation of this recommendation would be reconsidered. Dr. Brodsky's Recommendation 4: The NRC should bring in highly competent and broadly trained health professionals and health scientists at various levels of management (including the Commission) as well as staff. Staff Response: The NRC has 184 statf members with expertise in areas of radiation protection including health physicists and radiobiologists. In coordination with staff biologists in nonradiological areas, there is sufficient expertise to respond to most questions and problems that might arise, and to fulfill NRC's responsibilities in the health area. Moreover, we have initiated steps to hire a senior level epidemiologist to provide additional in-house expertise in this specialty. When additional expertise is required in these areas, the staff can call upon specialist / consultants representing a wide range of disciplines for assistance. In the context of NRC's role in health research, this arrangement provides the needed expertise with a maximum of flexibility and efficiency. 0L16.& Robert B. Minogue, Director Office of Standards Development

Enclosures:

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e l .,i d64"% ym, NUcLIAR REGULATORY COMMiss:CN f..! ) WASHINGTCN, O. c. *0$F.5 OW[. J' / January 12, 1973 MEMOPANDUM FCR: Jac:b Xastner, SD:ESS FROM: Allen Bredsky, SD:CHS8

SUBJECT:

CUmenT5 CN 7UBLISHED YERSION OF PAFER SY MANCUSO, STE'AART, AND XNEALE1 In reply to your request, I have reviewed the referenced pacer as pubitshed in the Health Physics Journal, November issue. This published version is identical to the one submitted to me by you as a section of Dr. Mancu'so's last progress recort. The progress report includes some introductory opinicns of Dr. Mancuso and some brief review of the history of data collection and selection of data, which have been abstracted frcm previous progress reports, l deem it is only pertinent to coment on the analysis itself. Since I have a nunter of statements to make regarding this pacer, I am giving only my main cenclusion below and am attaching a detailed summary of my findings, which include: a Preface, giving some of my own opinions as well as facts necessary to put my c:ments into perspective; a section of detailed coments on the paper, which presents facts and observations to support my conclusion below; and a final section en rec mendations, which includes my cwn opinions of further action that snouic ce taxen by NRC in yiew ai the natianal impac oi :his Mancuso paper, i:s recent attention in the press, and the nature of the prcbism. Conclusien: As supported by the at ached evaluation, I find that the suoject pacer by Mancuso, Stewart, and Xneale cantains str ng c nclusiens regarding the prcof of cancer causation by low-level radiation ex:osure; these c:nclusiens are not at all succor:ed by the kind of analysis and data, presented. In my opinien, the cacer has so many aosurdities that it can serve to prove cnly that the authors, although recutable for certain previous efforts in epidemiology, do not c:morise a team of sufficient breaden of scientific c:moetence by themselves to be able to evaluate the types of data involved in a radiation epidemiological study of this nature. /7)A, / & $c. D. Allen Brodsky Cccucational Heal:h Standards 3 ranch 'T. F. Mancuso, A. Stewart, and G. Xneale, 9adiation Ex::csures Of Hanforc l 'dorkers Dying frem Cancer and Cther Causes," University of Pittsburgh, ?ittsburgn, Pennsylvania 15251, Health Physics 13, :p 369-235,1977. t eg yvi wss-w-,r-w w--w

e i Or. A. Brecsky January 12, 1973 EVALUATION OF PAPER BY MANCUSG, 5 EWART, AND CIEALIU) I. Preface This preface of my positien and opiniens'is acw necessary for tne folicwing reasons: (a) As a result of my earlier conclusions of the invalidity of the Mancuso-Stewart-Xneale acproach, as reported in 1975 at the Saratega Spring, N. Y., meeting of the Health Physics Society, the pubitcation of my views along with the earlier NRC statament, and other direct and indirect statements, Soth pubife and =rivata, my name, reputaticn, and previous work with Dr. Mancuso may be somewhat at issue here. (b) My review of their final publicationU) again ccmcels me to issue a rather strong rejection of heir pacer, particularly in view of Dr. Mancuso's and Dr. Stewart's public promotion of their own invalid c nclusions as accepted scientific findings. (c) The paper by Mancuso, et al has already received naticnal and international press ana T/ puolicity, with the encouragement and participaticn of Drs. Mancuso and Stewart, who claim their findings as accep ad truth. (d) The effects of a public belief in the claims of Drs. Mancuso and Stewart, particularly in a democracy such as curs, could have a seriously adverse effect on tne public health and welfare, for :he sake of promoting by scare tactics changes in radiation safety standards that could result only in an unnoticeable and undetectable decrease in risks frem radiaticn ex:osure. Therefore, my rejection of this pacer must be clear and emchatic. T* us, i want to put into c ntext my c:ments cn the present pacer'1*) ( n by simply stating that I will not accept or tolerate any further attempts to imply--directly or indirectly--that my negative cements on the Mancuso-Stawart-Kneale paper are evidence of any lack of integrity or interest on my part in cotimiting radiation protaction U )T..:. Mancuso, A. Stawart, and 3. heale, Radiati:n Ex:osures of Hanford '4crkers Oying fem Cancer and Other Causes, Univ. of pittsburgn, Pittsburgh, ?a. 15261, Heal:h ?hysics E, pp. 369-285, 1977.

e e . of workers and all of the public. I can provide documentatien, cublicatiens, and personal witnesses to substantiata the efforts I have made for over 28 years to protact ;erscns frem unwarranted or even acpreciable risks of radiation excesure. Also, I have always ceifeved in using the mcst censer /ative estimatas of risk justifiable by available data in judging the maintenanca of as icw as reasonably achievable" exposures. My cwn theory cf the stochastig gature of cell changes inducible by chemicals and/or radiation (23 to produce cancer does in fact postulata probabilities of these cell changes that are finite at even the lowest dose levels, so my personal belief in the need to minimize unnecessary radiation exposure is further substantiated. I do not doubt that some of the cancer deaths may have been caused, in part or in toto, by radiation exposure, just as many of these were probably causec by non-radiaticn carcinogens in the work and non-work environments, or by "scontaneous" mutations. Mcwever, the Mancuso-Stewart-Kneale claim to have calculated meaningful dcubling doses, and estimates of probabilities of cancer that differ fr:m previous risk estimates of the National Academy of Sciences committees, is based on invalid methods of analysis as indicated in Section II be10w. Further, I wish to make it clear that I have no personal reasons to be prejudiced against Dr. Mancuso's cr Dr. Stewart's findings. I respect Dr. Mancuso for his dedicaticn and for his :cmpetence as a physfcian in epidemiology--but not as an analyst of cuantitative data, which are the final results of an epidemiological study. Also, Dr. Mancuso treated me well when he kept me as a co-investigator on this project for 8 years, and I am grataful for 'his initiation of the letter in 1966 that resultad in my tanure accointment as Associate professor at the Graduate Scncol of public Health, University of pittsburgh. During the 1960's, I also succor ed the recognition of Dr. Alice Stewart's work, in many reolicated studies, that made it prucent for us to accact her estimatas of the incidence of childhoed leukemia as induced by x-raying of the fetus in utero. Her achievements in these studies have been justifiably :Eencec. In fact, I informed Dr. Mancuso af her work and rec:crnenced her as one of the members of the Acvisory C:mmittae for cur project. But the nature and quantity of data collected in her surveys of 3rfish hospitals was much different than that of the present recort.b I Thus, let me state for the record that I will not accec: any assertions I am hiased against the authors, ncr against valid findings of radiation effects. It is an unha:py circumstanca for me that I find myself obliged to prepare suca a negative review Of Dr. Mancuso's and Dr. Stawar:'s work, and I have hesitated to write these c:cments. (2)A11en 3r:dsky, A St:chastic Mcdei cf Carcincgenesis Inc:r: orating Cartain Observations fr:m Chemical and Radiation Jose-Re' cocse Cata,' Mealth s physics, in press, 1973. p m, -.7-

e 8 With this preface, I will try to limit Secticn II to scme factual cbservations abcut the Mancusa et ai paper. In ecs: cases, these factual ebser/a:icns shculd be understandabie and verifiable by any intelligent persen, withcut prior training in radic1cgicai cr ciostatd paper.dstical sciences, simply by a careful scrutiny of the subject l Finally, scme further cpiniens of this reviewer will be presented in Sectfen III. II. Detailed Cements and Obser/ations 1. Before I deal with specific examples of the many scientific absurdities of this paper I should ;cint cut very emphatically that nowhere in this entire pacer is there a mortality rate *of cancer, or any of the defined ICD ceded neeplasms, calculated and c:mpared with a corresponding rate in a suitable "centrol" population of interest. It should also be noted that no procer c:ntrol "opulation is actually included in this analysis. Further, no stati5tical infornatica such as age distributicns, etc., of the 24,g39 employees listad as studied in the p_acer (Table 1) are given so-that the reader may himself properly standardize for age, etc., and at least make his cwn calculatiens of age specific cancer rates among Hanford workers for c:mparison with other groups. This paper ignores the vast majcrity of the daa collected cn the base peculations by Ors. Mancuse dollars of taxpayers' expens,eSanders, and myself at milliens of and igncres c:mmitments of Dr. Mancuso in his previous repor,s to car-y cut a proper ;:r s::ective analysig of the data, using several specified and available c:ntrei greues..dThe entire " analysis" of the present pacer involved merely the examinaticns of slight differences in average cc::::a:icnal exposures of those who cied cf cancer and these who died of other It will be shcwn wny, in further c:mments :eicw, that even causes.

hese small differences in :ccucaticnal ex;csure' are neither scientifically nor statistically significan, despite the strong asser icnsof Manc:Asc et al.

7 -- W T. F. Mancuso, 3. S. Sa.nders, and A. 3redsky, " Study of the Lifetime Health and Mortality Experience of Escicyees of AEC Centrac :rs, part I: Me:hedcicgy and Scme Preifminary Fincings Limited to Mer.ality f:r Hanford Empicyees, I in Radiation Pmtecticn Standards: the Six:n Annuai Heal:n dnys::s 5cctery iccical Symcostum, Ncy.Cuo Vad l 2-5, 1971, Vcl. III, published by the Columcf a Chapter, Health Physics Scciety,1972. "A mcr ality rate is the number of cases of dea h by a s::ecific cause, dividec by the tetai cocula:ica a: risk, :er year, suncaref:ed f:r age l cr calculatad for a s::ecific age gr:c:: t t: cc:afn -he ra:as per 100,0C0 ::ccuiatien.and usually mui:1piisd by 100,0C0 l e, e eye

a i J .4-Further, even if there were statistically significant, and censistently greater differences in average radiatica ex:osure for those who died cf cancer, this would not be a conclusive ;rcef that radiaticn caused a higher rate of cancer among these werkers than wculd be found among a c:mcaracle group cf workers in other industries, since there are many non-causative reas:ns that the average radiation dose could be higher ameng the cancer deaths. (There is, in fact, repeated evidence in the data of the paper that non-cancer deaths cccurred scmewhat earifer in the employee's life (as expected, since .. cancer rat.es incr. ease with age), thus not allcwing them to accumulate as much radiation exposure, on the average.) ~ ~ ~ ' ~ ~ " I believe that the authors have c:nfused two conditional probabilities: the conditional pr:bability that a worker will deveicp cancer given that he has received radiation execsure is not the same as the c:nditional probability that a worker will be f uno to have had a slightly higher recorded occupatienai expcsure given that he has already died cf cancer. The latter type of c:nditional probability is the one ceing estimated by Mancuso et al.(I:lin essence, in a p* r:scective type of analysis of the kind This retrospective type of analysis can never be taken to prove causality, because increases in actual cancer rates are not really calculated at all, and thus cannct be shcwn to foilcw radiation exposure in the appropriate time sequence, cannot be shcwn to increase with increased radiaticn exposure, and cannot be cc cared with cancer rates frii) have arranged the data m ther c:mparisen pcpulations. The several ways in which the authcrs , e.g., ac:Ording to calendar year of ex:csure, emalcyment year, et:., cannet be taken to be independent evaluations since all of the other factors are in each case ecnfeunced and mixed together in the same ;ccuiatien. (Scme of these fact:rs may themselves be c:rrelated with radiatien ex:asure and would thus be excec:ed := cause a scmewhat increased average exposure ameng the cancer deaths for several ways of arranging the data.) If the authors were truly interested in ceternining whether there was a real difference in cancer mortaif ty amcng Hanford workers c:= pared to appropriate c:ntrais, why did they not try the prospective anal where employees of certain age, sex, race, yment in a given ye of each cohort (people who enter ints enpic etc., could also be breken dcwn into sub-groups for c:moarisen against like sub-greucs in c:ntrei populattens? Also, in a prospective analysis the sums of years iived for each emolcyee c:uld also be calculated. (Cumula:ive life-years lived would be more sensitive for detecticn of overzli tortaif ty effects frem all causes than the c:unting of cancer deathst aicne.) Two inde:enden: analyses were already ;r:gra= red, tested, jnd used _.for_Gr.2an_cuscjn_amevi.cus11Jeacr ed ;rei_fginarf anairef s_ f_1ress e I + - 4

Y. ., myself.(y excerience at Hanford by Dr. Sarkey Sanders (#'d and by mortali' c /) The findings of my analysis basically c:r Ocorated those of Dr. Sanders, and I stated that "...several different statistical tests and calculations have indicated that -he gross mortality of Hanford emoleyaes, when c mpared with similar canstraints in regard te M e distribution, sex and race, dce,s not difiV dgMficatitiy frem tne sibling c:nt si populatten." N Mthcugh the analysis was Vmittedly preliminary, it was much more proper than any )f those of the present paper,(g'illIfand carried out in such a way that known errors or omissions would tend to be distributed randcmly and with equal probability between the c:mpared respective employee and control subgroups. Why was this result, and the methcdolcgy, not even mentioned and Stewart, either in the discussion

• of their paper (bv Ors. Mancuso l) or in their anncuncement to the press?

If the authors (II could not understand or trust the metheds made available by Dr. Sanders and by me, and computerized by Howard Fore at the Oak Ridge Ccmputer Techno1cgy Center, then why did they not utilite at least the statistical methodology for evaluating employee mortality data vs. c:ntrols, as developed for Dr. Mancuso by Dr. Carol K. Redmond and Mr. Arthur 4 LeGasse, Department of Biostatistics, University of pf ttsburghM? a T. F. Mancuso et al. in Radiation ?ratecticn Standards: Cuc '/adis, ci t., co. 2F14. oo Sarkey S. Sanders, "Of scussion of Scme Prepreliminary Mortality Excerience for Hanford Emcloyees and Car:afn Centrols,' fn Study of :.9e Lf fetime Health and Mortality Excerience of Ecclavees of MC Cen:rac::rs, :y T. ?. Mancuso, 8. 5. Sancers, anc A. aracsxy, Pr gress Recer: No. 7, NYO-3394-13, 1971, ca. I7-1 tc IV-lia. 5

7. F. Mancuso et al., in Radiaticn Petaction Standards: Cco '/adfs, oo. cit.,1972,Tp I7-il5 Oc IV-Il 5.

7A. 3rodsky, " Testing Of fferences in Life Years Lived and in Cumulative Mortality for Each and for Ali Age-Cchort Subgrcups" in T..:. Mancusa .et _al., NYO-3394-13, oc. cit.,1971, ?p. I7-115 to IV-190. 8 Carol X. Redmend and Ar-hur A. LaGasse, in NY0-3294-13,1971, Ec_. cit., pp. IV-191 to !7-207. . -=

- s _. All of the above methcdologies of Dr. Sanders, yself, Dr. Redmond with some rather striking results, in the preliminary st of these methodolcgfes for ccmcarfng actual cancer rates with thoe= None of controls have been mentioned or uttif:ec in the subject paper.II) (Is this so because the results were negative?) Further, Dr. Sanders who was dismissed as the sreject statistician enly ~ has submitted his own analysis of the Hanford data for publication, a which includes a table prospectively analyzing the mortality data'. between Hanford workers and controls, that can be D r. radiation. Although Dr. Mancuso had access to early verstens of Dr. Sandgrs' analyses, these are also not mentioned in the present different investigators. paper.d / A study, in order to be scientific uncontrolled variables that can affect the health of a human.Eoid by different investigators. population--must be creperly done and re Instead, the authors of the present paper do not even attemot to ccmpare their' findings' with other investigatcrs' work before leaping to strong conclusfens frcm weak data, improperly evaluated. Finally, if for scme reason the authors felt constrained to avoid all previcus analytical methods, and there was no time to develop a new crogram for retrospective analysis only,. then why did they not try to test the ranking of individual doses frem each cancer death with the individual deses of the ncn-cancer deaths for each of their ways of grouping the data?. This would have been more accreariate than dealing cnly with averages (wnich will be shewn later not to be significantly different). The testing of ranks of individuaT~excesures shculd also have been more sensitive to real differences in casa distributien becween cancer anc non-cancer deaths, if present, than testing the rankings of small differences in average desa between broad greucings. Anycne who kncws the magnitudes,. and their variaticns, of the natural background radf ation and/or medical exposure, over the years cumulated by the workers during radiation monit: ring would see that the small differences in averaoe dose would be made ccmoletely insignificant if other rediation excesures alone were included in the study. of a samole of Hanford employees, for theIndeed, the average medical excesure 1 1946-56 pericd, was measured to be 39 mrem (3.9 "centirads" in the Mancuso-Stewart-Xneale termin logy), weighted by the mass of tissue e.acsed as indicated by the x-ray films re-examined for this study. TO) This means that for an average pericd of monitoring at Hanf0rd of abcut 5 years, an addi:icnal 5

3. 5. Sanders, "Lcw-Level Radiaticn and Cancer Deaths, Health Physics, in cress, 1973.

IO W. D. Norwood, F. L. Rising, C. W. Xirklin, A. 3r:csky, 3. 5. Sanders, and T. F. Mancuso, " Cumulative Dose fr m Otagnos:ic Radiatien, Am. J. Rcentgenci., Radium Ther., anc Nuclear Med. CXV, 642-448, 1972. 4 ~ .,n-.

. medical exposure of abcut 240 mii}d) ems was incurred per em:loyee. i-No mentien is made by the authors of the possible conf:unding of their "results" by this medical ex;osure and its variations, in view of the small differences in grcup average doses that they deem significant. However, Dr. Sanders (Reference 3, p. 31) did shcw frem the pilot study of medical exposures at Hanf rd (1946-E6), the medical excosures would not -han exposures very much. 3) ge the r.anking of individual occupaticnal 2. Improper and misleading tenninology is used throughout the pacer, e indicating the authors' unfamiliarity with the radiation dose d4t4 examined in the study. For example, on page 369, first column,ll) eighth line frem the bottom, the authors state "In several high risk occupations the workers are also examined (at regular intervais and following accidents or radiation ' leaks') for internal decositions of radioactive substances." This implies that all emolayees included in the Hanford bicassay pr gram were subjected to "high risk occupations. This assertion by itself, occurring so early in the paper, indicates the authors' initial bias that any exposure, no matter how small, results in a "high" risk. The authors apparently do not realize that there is a wide frecuency distribution of internal exposures at Hanford, most of which if e belcw a median to which no knowledgeable scientist in this field would attach a "high risk." Internal exposures, converted to units of dose equivalent when the necessary calculational :hodels are availaole, are generally an extremely small fraction of the external deses 11sted in *he pacer, which presumably are the only doses used in the authors'(b analyses. For adecuate study of the effects of internal exposure, the kncwn cases of significant ex:osure must be secarated out and examined carefully in regard to all appifcable variaoles and medical findings, as originally planned by Dr.(Mgncusa and his colleagues. No mentien is made in the current paper l / of the recognized difficulties (Reference 3, p.179) of ccmbining internal and external excosure-- as well as otner uncertain, unkncwn, and variable exposures--int a single analysis of the data. On o. 369 of the paper,(1) the statement Radiaticn monitoring has 3. been in cceration since 1943..." is wrong. This iias been corrected to 1944 in the c py of

• manuscript included with Dr. Mancuso's

' final pr gress recort.( UII. F. Mancuso, " Study of the Lifetime Heal'n and Mortality Ex:erience T of Emoloyees of ERDA Centractors, CCO-2423-6, rinal Report #13, Cecar* ment of Industrial Envircreental Health Sciences, 3radua:e Scacol of pubite Health, University of pi-sburgn, pit sburgn, ?ennsylvania 15251, Sept. 30, 1977.

8 a. In the third paragraph of page 370, the authors intreduce their Table 2, which shcws that the procertion of exposed workers (one or more ;ositive badge readings grcuo and 51% for the non-:ancer) was 56% f:r the cancer death deaths. As indicated before, with all ages and cohcrts afxed ::gether in each death grcup, this ccmparisen is meaningless; the larger proportien of radiation excesures in the cancer-death group is probably due to a higher average age at death, and a longer employment and exposure period, and is probably a consequence of the fact that accidental deaths are relatively high compared to cancer deaths in icwer age grcups. Even so, the difference in proportions between 66% and 61%, and certainly the difference in avertge dcas} cn the initial versitn is not striking statistically, as shown in my c:mments(12 of this paper. Also, 1* I ;ointed out in my c:ments(12) on the initial version, "Frem Taoie 1 alone, one can ccmcare the ratios of non-cancars to cancers for males and females, wnich becomes 4.25 and 2.28, respectively. Since one cbserves from the same Table that indeed the males have received the higher average radiation exposures, then why do they have a much icwer catto of cancer to non-cancer deaths, if this kind of proporticnal mortality data is presumed to be valid in showing by other ccmputattve manipulatiens that this data has discovered the radiogenic induction of lung canced" is.now Table 2 of the pubifcation,'(i) excect: Table 1 of the original paper it is noted that the authors have new cleverly removed the cata en females (because it centradicts what they wculd like to be able to prove?). 5. Their Table 3, breaking dcwn cancer deaths by tyce of cancer is stated to show a wide variation.in average deses cf nose dying frcm specific diseases. Again, the lower average dose for accidental death is to be excectad, since they die at a ycunger age en tne average. ?!cthing is cresentec to show that the rest of :his wide distribution has any relationsnip to radiation carcinogenesis as cccosed to etner scurces of stechastic variation in the data. The dose data are available en the project tapes, but no data are presented regarding the de dose variability within the grcups presented in tne pacer.(1) gree of 5. In Table a, the authart do attamat to ecmcare the Hanford ceaths to a "centrol' pcpulation of U. 5. White Males (1960). Mcwever, the

02) Memo, Alien 3redsky to Mike parsant,1eview cf pacer by Mancuso, Stewart, and Xneale :n ?aciation Exposure f Manfced Workers Cying fem '/aricus Causes, Cc.:cer 1975, dated Nov. i, iW5.

l i 9-reader shculd beware, and c:e that the t:tal of the " expected" deatas are not as actually taken frcm the authors' ettad reference. The " expected" death numbers have ali 5een nomalf:ed so that they will add up to 670, the same as the observed t:tal cancer deaths of Hanfcrd workers. Thus, the individual values of " Ratio, Obs:Exo" in the final column are fictitious values, and not really ratios taken by dividing actual mortality rates observed by expected rates calculated frem the cited reference after standardization to the same age distribution, etc. Further, the white male U. S. population (which includes many who are already sick) is not an appropriate population for ccmparison to the Hanford worker population--as emphasized. to me by Dr. Mancuso himself a number of years a For example, by the kind of normalization carried out in Table 4,gI the Observed / Expected ratios might ccme out somewhat larger for neoplasms 1-8 simply because more persons in the U. S. white male population died earlier frem other causes before these types of necplasms could develop. This may not be so, but should have been investigated. The type of ccmparisens shown in Table 4, if carried out properly, would be suggestive of clues (but not "preof") of types of cancer that might be produced by radiation. Indeed, as stated earlier, I believe that at the higher dose ranges shcwn in Table 4 there must be some probability that scme of these cases were induced by radiation. However, as presented in Table 4, most of the "Obs:Exp" ratios for diseases 1-8 do not apoear to differ significantly frem 1.00 (althcugh most are greater than 1), :ansidering the numbers of cases involved and the chances for purely natural randem samoling fluctuations.

Thus, it is possible frem the data as 1: stands that T'able i c:uld just as validly (cr better invalfdly) be used to "preve" :ha: low-level radiatien (mean cumulative cases belcw 1C0 cen:irads (I rad cumulative over curation of employment)) reduces neoplasms Of :yces 9-18 in the Hanford employee population.

7. "C:ntrolled analyses," page 377: It must be rec:gni:ed that these analyses that are stated to be "... controlled separa:ely for five possible scur:es of false imoressions" are not really seaarate and st chastically indecendent of each other. Only with a prescective analysis of the type mentioned previously, breaking dcwn the populatien in : subgroups that are relatively hemogenecus wf h rescect to all important variables at once, can a properly *centrolled" study ce done. 8.

• Calendar years,* = ages 371-372: Again these results of Tabie 5 and Figure 1 may :e exclained by a slightly higner age at death for cancer i

deaths. Note in Table 10 :na: f:r all but one age grecc, the average radia:icn ex:osure of 2cse dying of cancer is grea:ar than -hcsa dying by accident. The cancer dea:hs :r:ba:Ty came scmewna: iater in age, i

n :ne average, aven within each age greuc.

s. 4 Furthemore, note that the authors coin a teminoicgy "hich risk" year to denote any year where the average radiation dese to memcers of the cancer death grcup is even slightly greater than that of the non-cancer grcup. First of all, they are confusing dose with risk (orresponse). Second, they are presuming wnat they are trying to prove. Third, to show how precostercus and unscientific this is, note that for all. years in Table 5, the averages to be compared (for 1944-57) are merely 199 millfrem= per year for the cancer-death group, and 187 millirem per year for the non-cancer deaths; for 1958-72, the respective averages are 513 versus 177 millfrem per year. (The authors do not state whether their averaging calculation was weighted by the number of employees alfve each year.) Considering that each year an employee must receive (a variable) 100-150 mrem per year from natural background radiation (including natural activity in his body), as well as the (again variable) 39 millf rem per ve-average frem diagnostic medicai exposures as cited earlier 00Ir(which as everyone knows can vary for an individual fecm 0 if he did not have an x-ray that year up to many hundreds of millf rem), then comparison of the average doses in Table 5 makes it clear that they are effectively the same between cancer deaths and ncn-cancer deaths, i.e., known other types of excosura including occupational exposures at other facilities than Hanford,M could obvicusly obscure such small differences in average cccupational exposure at.Hanford between the cancer and non-cancer grcups, if they had been reported. Dr. Mancuso had also on many previous occasions emchasiced that conclusions regarding. radiatten effects could never be drawn withcut exami agentsarenotevencentionedinthepresentpaper.y,in effects of chemical agents in the work envircnment. _ possible Chemical These facts alone are sufficient to remove any credibility in any findings of this paper. They also indicate: the lack of kncwledce or understanding by the authors of weli-kncwn scientific facts, even those with which they have previously been asscciated; and a lack of under-standing of proper scientific method and teminoicgy.

• There is accarently an errer in the text en page 372, where 14.9 is given as the dose instead of 19.9 as in Table S.

U3)T. F. Mancuso, 3. S. Sanders, and A. 3redsky, NYC-3394-13,1971, Lo_ pp. PI-3 to r/-1; see also the referenced crevicus cregress recor.s of Mancuso et al. for mere detailed discussion of the need to examine the effectsTfTen-Hanford ccoucaticnal excesures as well as chemical carcincgens in the work environment, before drawing conclusiccs.

. The absurdity of the data presentation of Table 5 as acccmcanied by the assertions en pages 372-373 should be cbvicus to the naked eye without the necessity of statistical tests. Mcwever, for the sake of anyone who needs a test, the follcwing calculations are presented: t-Test of Of fferences in Mean Excesures at Bottem of Table 5 19a4-57 It is reasonable to assume for purposes of a t-test that the means of each set of annual dose averages aporoximate means of sample values frem a Normally-distributed variate even though they do not. The Central Limit Theorem helps us here, and a t-test wculd be more pcwerful than a non-parametric test in discerning any differences in means; this would favor Mancuso, Stewart, and Kneale. The weighted sums of squares fer the two columns, respectively are: 236(26.5 - 19.9)2 Vatghted 550 332(11.9 - 19.9)2 = Ca 324(12.5 - 19.9)2 310(12.4 - 19.9)2 + + 301(22.2 - 19.9)2 287(28.4 - 19.9)2 + + 184(40.3 - 19.9)2 168,932 = Variance 5ecween Annual Means (Ca) 168,932 = (236 + 332 + 324

• 310 ' 301

+ Z87 + 184) 168,932/3948 42.79 = = Standard Deviation 5etween Means = N 2.79 !. 6. 5 =

I Weigh:ad 330 900(25.0 - 18.7)' = 1257(13.2 - 18.7)' non%a 1168(8.1 - 18.7)2 1100(12.8 - 18.7)2 + + 1118(20.2 - 18.7)2 + 1006(23.T - 18.7)2 + E67(41.6 - 18.7)2 + 557,824 = Variance Setween Annual Means (Non-Ca) 567,824/(900 + 1257 + 1168 + 1100 + 1118 + 1006 _ 567) = E67,824/7125 = 79.58 = Standard Deviation Between Ncn-Ca Means = 1,8.9 The follcwing t statistic shculd approximata that of " Student's " for 12 degrees cf freedcm: t = (19.9 - 18.7)/ 42 79 79 58 = 0.27 0 0 Since, fer 12 degrees cf freedem, to.08 = 2.18 Vor a N -ta h tast, and tg,gg = 1.78 for a cne-tailed tast, either type of tast wculd accect the null hype:hesis, with cpen arns. 3cch the cancar and non-cancer creue average deses are very much the same statistically, despita scme iurely apparent excess in :ne cancar death group. / 1958-72 Calendar Years Sinca there is ebvicusly even less relative yar abfitty be: ween annual d means for 1958-72.han fer 19a1-57, the =eans 51.3 and 47.7 can aisc be considered well matched. Tnus, there is no point in further discussing the ridicuicus counting of *htgh-risk years

• in the last t:ve columns of Table 5, Reference 1.

Ccnclusien: The cresentad analysis by Mancusc-Stawar -ceale of Table 5 cy 1.self invalida:as any ccnclustens from c:her fluc.ua:icns ceserved and discussed by them fn their da.a presanzations. t 1

1-III. Rec:mendati:ns In view of Xneaie pacer}( )intarnaticnal 1 : anti n already given 2 the Mancusc-itawar - I feel da: it is iscr an: O reitart:a a: dis time :a ain rec:mencations:

1. Tne NRC sheuid urcently initiata its :wn indecenden: evaluaticns cf de mer.al t:y ex:ertence of =e nanforc werxar :ccuiaticn.

This 1s nc: cuplica:1cn ci Cecar..an: of Energy eff:r., sinca \\as I have indica.ed earlier) repitca icn of such studies is necassary for scientific verifi-cation.- Supervisiert of the study wcuid. aisc assist NRC in deveiccine its own-independent capability for examining reper ad heaith stud'ies. As ycu-knew, I have made a number of altarnative rec:tanendaticas in rega t: how this can be done hcnestly and ccfectivel and c:mpetant grcup of heaid pr:fessicnais na:y, and by an independen: fields of radiatien epidamiciogy and bicstatistics.icnally rec:gnized in the

.ce ene reascn or another, my varicus rec:mendaticns have not been im::lemen ad, ner has any effective pr:gnm fer NRC independent studies cf de health sta us cf individuals expcsed 2 radiation been initia:ad. While milifens of dcIlars have been scent by NRC cn much-needed resear:h t: bettar define safety ;aneetars neeced in react:r ifcansing er in the quality c:n:rci of hardware, :he NRC's research pr: grams and tachnical su: pert pr grams n

in regard ts human heai2 effects studies, which really audi tne everali and mest imcor.an per' r. nance cf the agency in assessing is pr:tec icn cf eecicytes and de public,'are entirely inadequate. Aise, ensidering the present c:ntroversy cver ndiaticn protacticn sandards, inscfar as the validity of varicus ecidemiclegic investigattens and human desa-responsa mcdeis fer estimating risk are encarned, human risks (Or at least upper limits of risk) fr:m ndiatica ex:csure us: he ch:ained f m precer hicstatistical and eridemicicgicai anaIysis Of icng-carm ca:a c:llec.ad en human ;cpula:1cas ex::csad = radiation. I rec: mend tha

s. dies en de idanticai ; :uia i=s :f dea-hs as used f:r the.Mancurc-!:awa.m.<neaie investigati:n, as well as =e em:ieta

culatiens c

ilec.ac fer de Originally-in:anded ;r:s:ective anaiyses, he imediataiy ini;ia.ad in accreanca ni= =e recan: ;r:;cral b Ridge Naticnai LaberI=ry, as su::cer ad and =difiec by my recan y Cak emenndum tc Rcher: E. Alexancer.' I maka 21s rec:menda:icn urgen:iy,.

since I believe da: dis ;r:;csai is cc: :nly de :na mes i=ecia aiy at hand, but also meets the int:ial recuirements ! aid d:wn by us in cur scTicitatien of this ;r:cesai. Aisc, incacendenca, :cfectivi y, ncii-catica, and c edibiiiW us be acnieved by bringing in a: an early s age a numcer cf indecenden: =nsui:1nts =: On identical dau; (h) =nfim the unifd-(:i:a) :1r y cut teir :wn s.udies 7 Of de cuality Of da u used for each s udy; and (c) ;r: vide a.=mcieuiy =en f: rum f:r de examina:fcn of 21s inf:rma:icn :y 02ers wn: nay wish = car y : : dair Own investiga:i=s with =m:T eu =nfid-* -~-= "$ 2 have ac: taen imer=eriy am ered sic :r seiec ac. ~~ 7 a 4

e O - Ta. ,I urge succor: Of de Oak Ridge National Latera-ev : =csai ac: gcause it is the enTy ;cssible accr:ach, bu: beca".:sa f: was -he ac;r:ac w.aw we dec1ced.: scifcit Over a year acc and i is dus 'r*~=d d- ,fer a reascnable su:n (less San C.25 per year :f de NRC -esea.'y ~ " ~ udget).

h Picposai,.cr us are hcnes: and capabie scien:is:I beif eve 3, 1 g 1:ys;7 gn;,g73

'can be verf ff ed by the means that are mentioned in my ahcVe statame and in mere cetati in previous rec:mendations. the work and are in close proximity t: Tney are ready to begin a vast amcunt of data for the Hanford population, wnich is securely maintained in the cacable hands c., Mcward rare at the Oak Ridge Comcutar Techncicev Cantar. must be pr:perly protactad.. I believe da I'h1s data the CRIll er:c:, unda-Crr Xen Peggencerg and Cliff Fatrick of the Heat:h and Safe:y Resaa.'hh C sian, can and wfTT manage :nis program fndependen: cf te work bein-done by Cak afdge's Asscciatad liniversities and :nars c:r te CegaNa c.,cnergy. I,. We had inf tfatad this ty;e of ;rejec: a urgently rec== ended then, we would ne still be ficunde-in arcur$ as Over a year acc lata and after the fact c:=menting enty en rearnneacents hf 5he aA s seinc:ac unich as phave sndicated abcVe c:?ltains many and absur:1 fes er presenutien and analysis. ye negative views cf c hers en the NRC staff fn(I de net believe that 5 a;ard :: iis Pre ect stam fr:m any rtal knewiedge by dem f de data f:selffnitiaticn cf a fr:m an ,nves.y real ex ar:enca of any cf them wita any kind :f radfcecicamicicaf: nce ga:1cn. 1 nave a.:mic energy pr:gra.m.ta, had first-hand kncwledga ~ rec:rdec.cr de n, eai as weII'as f :m 3 y. ear as a c:-invas icas:r en cbtz{.ning One c:cpera:ica cf 2cra ;casassing an -e ancusc s :cy 1:se,tt, i teitsy, =a we 2n agsgg ge cpfig,.,ff g, I.n additten :: -he rec==acda:1cn f;r a s::-ic: reexamina:ica :f :- ..an, r: mr:alf:y ex:erienca, I cave aisc =ada saveni :r aca. n=e f;cns regard 1ng a heai:h eifac:s nsase:a : :enz 9 r NRC sin man-ad-{.1cnal rec:=endaticns :eicw, sinca '. ay have .a

.at Scvernmen Z 5 years age.

I shall brieMy sur=ari:a thesa ~ Z. _Tne NRC shcuid imacfa:aiy fnf tfata : Tant f:r a icnc-ta-r :r:s ective foli:wuc stucy :1 all smalcyees cn:.:ree f:r esc a::en n:crure :n itcansac nuclear :cwer sian s. .again, nere it an a sa vnere i: sea s = me.1RC sacule nave a ;ri=e resear:n, administn:ive, anc accidag res:ensibfifty. 7c data, cur c:iiec:1:n cf adta-1:n d:sa (and reia ad

ccula icn fden

f fica:icn) rec:r:s has been very ifmi ac and nacha. a and very Ift-i form excao: =e usa :an be :aca :f 2is ca.1 as =i'ec:ac f n f s :resan:

Mcre==1 era =iiec-icn Of can n: examine gr:ss over1TT u:: sun en:i'fn =a ' :us:das. ec: :s managec by a= r= ria:a c=mu ar tacan4:ues anc avaTua ac by a :aam,:f :r:fessf:nais== rising

.n. s '.q % po..s A...u. ~ 2 Q...y 'i z.y s. s.m. t. c.d, wcy 'n.a s..n.c.V1 a

v.....,,./. 4.

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4 infcr:a:icn f:r icat-tar: audizine. :f NRC's requia :r.,.:r:e.n: 1. Althcugh I have a :hasi:sd initiating a study wi:n reac :r ifcznsaes, sincs key art a :cre h::cgenecus industriai gr:u: anc sc:a ci te data c:llecticn ;r:biecr wcuid he easier, I feel that aftar a fsw years Of experienca, f:ii wup 1:udies shcuid be crgani:ed :: ::ver ali Ticansat a:cicyees whc art ex:c, sad t: radiatien (uiti=ataly, en a na:icnal basis, including' aiT statas dat cuid pr: vide data f := their programs). Tnis ay scund everly actiticus, but it wculd net be an incrdinataly ex;ensive pr: already Cade) gram c:=:ared. 2: its vaTue ('and to ex:endi ures en d:si=atry if it were pr:periy c:nceived and managed by an accr:griata team cf heaith speciaT 4sts and scientists c:gni: ant w1th 1TT as:ec.s of the data and evalca:icns invcived. It is aisc i=:crun that the escicyee felicwup studies he i.nitiatad new, t: avcid the en:ense in Tataryea attameting t: recastrueren::sure, identificacica, and x-aif ty data cn a re =specti've..hasis, as has been d:ne f:r many mii~ ions cf dollar: in the AEC-EiCA Health and Mer:2.iity Study under Dr. Mancure. 3. I have aise rec:= ended an indecendent :r:fec-t carry cu: a c:::Teta reexamna:1cn cf avatiacle ec:cemalecical anc ::csu:ts:t:ai mernces in crear = arme at rec:==encec menneccicates acc recuirsc ca:a ranks, as ac:actac ace sc=cr ac :y an acvisory :aam c:mecrec cf r:fessienais of :ne n1cnes: cuality anc recuta: Ten. Al = cugn my primary cu:les in recan; years nave act inciucac. estcemiciegy, =y recan; and ;:revices examinatiens cf sc:e cf t; e activities in cis field have indica ad = me... .. e ..e. is ...ea1<.ieg.,.,..,. ;s 4. a. 5.e_,+t ,e 4..,

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relatively =nfused s:a.a. 1 tis ine!udes the =iiteticn cf essantial haald anc mrtali y s.a istics en a naticnal',hasis, and is n:: cniy .,. i a._.,a ~ a c.<.- i, e. na., t..,4. , 4...

e. s

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, e......i... u s.... n.. 4cnai and s andard. etheds f:r assessing haai2 ef'ec s :f envi=n-- r1: nen.ai agents, f=d addi-"ves, acc drugs :n a na:icnai ;c:uisti= basis has indi sc:!y resui ad in adverte eac s en aII cf us ;ers:naily as weil as e, n.he na:ica as a wncie.. I rec =end high ;rieri y :n a study a...u. 1 a. c. ~ a. .. i,,s.,.s w t.sh :.t..a 1<..es,na .e.u >, .r..,.,, a. 4 ecidemiciegic s.: dies ;ertinen: cf ltRC's rsdia:1:n pr::ac:1cn standaris.= te evaluatica and further devei=cen: .t.

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recutacte, inc :r aciy :..Tnec eai = : fsrs::nais anc sa!= scisc-s:s 4: varicus ieveis cf canagemen i:nciuc:nc =e Cc= ssica1 is weii is s:1 f. ahG c.... e:anca in :.~.e resaar:n anc assassmen :f neai".. enac:: ' anc risks ta zign: he pr:ducai by -1dia:'cn s~cuit sdu1T f = : ..e acca i n.9 .e4.. n,...:...e :. sa.- a..a. <.'...e a.. '...,... v e. d. ~", =.. ". s=w. .'dv-"..=.=.". ..s ave haar: ne ask mytaif, again and again during.he ;as year, "'cw .a. ".. s.= e.../ *. *.=.....e.... ~. =..v =..=.~.-. i.", w h,v.= ~. w a..-.". '. '..'.="..; 2

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from my earlier ex;erience in the At mic Energy C:mmissien, as well as from folicwing the regulat ry program over the years, of :he excellence in reac:ce safety evaluation and review as carried out generally with an eminent Adviscry Ccmmittae on React:r Safeguards (ACRS), in addition to very camcetant NRC regulatory staff memoers. hrougn this review process, I be11 eve this agency nas gained an cutstanding ability anc reputation for overseeing safety in the design, construction, and opera-tion of nuclear reactors, as well as some of the types of facilities. However, although much due attention has been given to reactor. operations 'and the prevention of malfunctions, and radioactivity releases, I do believe that some of the currer.t need to soecify additional design con-siderations to reduce empicyee occupational exposures to as icw as reasonably achievable levels would not be as acutaly overdue if reacter development had much earlier incorporated a greater participation of health scientists and health physicists. It has seemed clear to me for some time that, since we are ccw an indecendenc re ecidemiology) gulatory agency, our health research crogram (including shcuid not ride on the coat-taf f s of the Department of Energy. At my level I am precably not aware of, nor have I been informed of, all the reasons that my proposals have not been implemented. The only answer that I can arrive at to exclain the inadequacy of the sc pe, organization, and level of NRC's health science and health followuo programs is that the management of this agency was born cut of the professional nuclear engineering, physics, and legal disciplines inherited from the At:mic Energy Ccmmissien, and -hus neither these professionais (nor Ccngress) have rec:gnized the imcaiance of. cur NRC regulatory crogram in regare to resconsibilities far understanding health effects of radia-tion anc follcwing tne health status of licensee emoloyees excosed to radiation. In my coinfon, the agency, as so c:nstrue:ad professionally, cannot acecuately reali:e the accropriate efforts required to deal with this sucject area. '4e are still fignting fires af tn staff memcers a: the icwest level who (al:heugn gece, c:mpetant scientists in cer:af n areas) have hac little or no excerience, and no creditable recutations, in the health sciences, while the Cecartment of Energy is enlisting some of the too scientists in the country in their efforts. Should the Decartment of Energy, with pr: motional responsibilities in regard to energy, be more interestad in radiation health effects than we? The major role of our Advisory Committee on Reac:cr Safeguards may be c:n-trasted with the c:mplete absence of a :c-level greuc :na: can cbje<:tively evaluate radiaticn excesure standards, risk estimatica methods, and research anc Other crogrammatic recuirements in :he area of health. The Nuclear Regulatory Commission, an agency of 2,700 : ecole, dees not even have its cwn Medical Of rector or tc:ucational heal h gr u: to care fer its smalayees, wnfle it (pr:perly) writas s:ringen: regula:icns en

, hcw its ifcensees are to reduce even its smalles: risks as icw as reasonably achievable (ALARA). (I still have not had any resconsa to my inquiry regarding an entry medicai examina:1cn. It seems that we had a better program at AEC back in 1960.) I want to make it very clear that my cpiniens as ex:ressed in this -anno haven't anything to do with personal feb dissatisfaction, or dissatisfaction with things that NRC is doing. I believe that existing NRC programs are important, and I am happy with my job in the Occura-tional Health Standards Branch and with the important radiation protec - tion guidance we are developing for the licensing crograms. My supervisor and co-workers are among the Government's finest. I also have ne specific problem with the individual qualifications and attitudes of other management officials. My frustrations rest with what NRC is not doing, or not doing adequataly. I do not believe an inordinata amount of additional funding and staffing wculd be recuired to alleviate these deficiencies. Since, as you can see from my above remarks, I feel very strongly about the importance of this matter to this naticn and : the health and welfare of all its citizens, I am planning in the near future to make my views known outside of 050, and to other cognizant legislative and administrative officials. I want it to be clear that these are my cwn personal views and do not necessarily represent in any way official Branch or agency opinion, or an attemot by me :a recresent anyone but myself. I am writing this only under the primary cbligaticn that I feel any Government employee in a democracy has, to voice his individual views when he feels that they are in the nacional in:arest. 4 s I l a ,,-n-_

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e . -. - - _. ~. ~3 ',..# *'%c Enc 1Csure 2 ~ ,( o, UNITED STATES + j NUCLEAR REGULATORY COMMISstCN f, l WASHINGTCN. c. C. 20555 's, v,/ FC 0 : 'NS MEMORANCUM FOR: Robert 8. Minogue, Director Office of Standards Cevelopment FROM: Edson G. Case, Acting Of rector Office of Nuclear Reactor Regulation

SUBJECT:

EVALUATION OF PAPER BY MANCUS0, STE'AART AND KNEALE, BY ALLEN BRODSKY I have reviewed the attached memorandum of January 30,1978 frem William E. Kreger to Harold R. Centen on the above subject. I agree with the positien taken in that memorandum. ,7 / Q /

• e

/ Edson G. Case, Acting Direct:r Office of Nuclear Reactor Regulation

Enclosure:

tiemo fm. W. Kreger to H. Denten dtd 1/20/78 cc w/ encl.: H. Centen R. Alexander J. Kastner A. 3redsky W. Kreger R. 'lollmer R. Gotchy

e e- -nclosuro 2 s maats4 e. / Ds UNITED STJ.?!5 [.*f,) ", NUCuaAR REGU'ACRY cc.',iMh:lcN , a% - .,s WASHINGTCN. O. O. 20$53

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%.n.. .. ma ...s n.. MEMGRANGUM FCR: Har:1d R. Cent:n, Ofract:r Division of Sita Safety and Envircnmental Analysis i f THRU: Richard H. Yollmer, Assistent Oirect:r,. ' ' for Site Analysis, CSE

.//

1 FRCM: William E. Kre' er, Chief g Radiological Assessment 3 ranch, OSE SU3dECT: EVALUATICN 0.: PAPER BY MANC'JSC, STEWART ANO KNEALE, BY ALLEN 3RCOSKY I have reviewed the subjec ;acer, and have aisc been in t:ued with E53 during the past year regarding Mike Parsant's work in ac:aining evaluaticns of :he Mancuso, Stawar: i Kneale paper. .I have.the relicwing c:mments 3n par: ., nec:=mendations, or. ne su: set pacer: 7. III.l. Since the Manidri study was CCE funded, I wcuid favor requesting EPA and HEW : avslua:a -he ner aif ty axperience of bc:n Hanf:rd workers, and a larger samais of racia-icn worxars, tcta fr:= CCE instaliatiens anc MRC if cansad facilities. I :: nc: believe NRC is in a reascnable pcsiti:n :: ini-iata its wn evaluacien, cus : a shcr aga cf accropriata ;acpia. I aisc believe 1:.scuid be cre a :rt:ria:a

1sk agencies tha: wcuid a: pear :: have bc n ne rign: kincs :f peccle anc :he righ:. mis:icns, t: dc -he J::.

A!:ncugn CCE has funcad such studies, we shoui: g: :: an indecenden: enviewer anc resear:n scensor, I think. I d:n'- believe we shcuid ge :: CRNL (:r c:ner natienal 1a5.) because we use -hem f:r so many :hings :na: we c:ui: be critici:ed for influencing :ne answer. III.2. I believe NRC shcuid request an at:re;ria:a agency :: deveic: a icng term :r:spective f:li:wu: study of all emeleytes Of MRC If:ansaes, as centi:ned in I!!.i abcve. I d: no: believe "RC shcuid nave the prime ac=inis ra:ive, resear: and audi-ing func: On, n: wever. Ua sacuid perha:s : anga a regui'a:fon :: take such a study easy--by requiring :na at:rt;ria:a racia-icn :ata ::iiacti:n and health l inf:rma-icn mcnit: ring, tu: ne shculd reques: s: acce aisa, itka HEW, ...A. l ...,..4.w./. ow ww ..s. t [ 9

o '!arold R. :enen 2 .13 III.3. l~.a r c :runda ti n of Siis scc-i,., m ur: n hav :ce ara.u n CC e rnr 09.C 20 car -l nit..ind i' i. I:Qn :icar ?c r:: Hs: -jqy 'ra.3 } ? benefl! ucuid be. Ue dc !uve 'Se r.ocani::1 ac:f vity A-;:) an.1 31:o a catagery G technical activi y to sun.c.7r the re: ear-;, a.,L :nnne.m health of' cte calculation:, ;4tici av :. 0viin a b.vri-sai-5 par-ial ansuer to tnis itsm. III.4. We do e":lcy as consultant: reputabTe, a;:d brcadly trained health ?.cienti:.= ntW.er o f ':f chiv c :n.c,atant, P.s c.5d heal th,ro F*ssionals. I rarsenally believe that this has been ard is an annrcariats' and satisfactory way to got cur :=ad

crved in this araa.

I don't believe 113 can attract th+! f el *O ful I tim.w.nlevj=qn t, ' !C2H30 ot!.** activi tiOS, even broadened as Srnds'<y wan: at.,.r3Ct1Ve to such ;'acc. .in, will not nc far anot:gh to M 3 ::: ie. cc...a 4;:en/. ~,. m.._

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' ; C c 'ss ENCLOSURE 3 .'c t) . - m.Q T1-qs ., a: 3773* 4_ f s us :4,9;7.t Coments from NMSS -, c, a,.cr, % 4 i.,,'..x,.%,, .--j ,d.4 -p4 a s.:).#,# e + " A g ,'g'$. 1 .O .r# e 6- { $ O', '% ip'?,

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e e .m UntTIO STATZ3 - [t,Pf6 } NUCLEAR REGULATORY CC.*,1M!sSICM 5. i. YY ! wAsamoren. s. c. 2csss h#h r. . p,r FE3 i ? 1973 MEMORANDUM FOR: Robert 3. Mincgue, Di rector Office of Standards Devele;:::ent FROM: Clifford V. Smith, Jr., Director Office of Nuclear Material 2 Safety and Safeguards

SUBJECT:

EVALUATION OF PAPER 3Y MANCUSO ET AL AND COMMENTS SY ALLEM SRCCSKY I have reviewed the attached.:ecorandum from Richard Cunningham to Sheldon Meyers en this subject. I believe the suggestions in Cunningnam's i::amorandum ert: your censideranian for ;cssible regulator / acticn. 7 'Cli ffo . Smi th, Jr., Di recto Office pf Nuclear Material Safyty and Safeguards

Enclosure:

as stated cc: EGCase JXastner WKreger MMais ch - WPBis hop HLcwenberg DANussbaumer J8 Martin 330

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wasumcTeu. :. c.::ssa a t M v:,, i g, ,/ .icve::er ::, m: R. J. Mat:scn, Direc=r, Siting, Feal.3 and Safeguards Stancards, 3: Taru: J. Xastner, Chief, Envire=enti Staccards Branca, 50 r ?- AE80RT OF THE STAFF COM!ITTEE TO 57dDY tie : APER "RADIATICM wuddRES CF HANFORD WORKERS OYING FRCM VARICUS CAUSE5 The cemittee was estabitshed on Oct:ber 27, 1975 to study the subject document, to evalua.e its methodcicgy and results, to rec: mend if any NRC action should be initiated cver -he shcr tar and to presan: a rescre of these findings and esc =endaticns. Tr.e c:mittas was :: :csed cf S. Yaniv, O. Rubinstain, A. 3recsky and M. ?arscnt. M. :arsent was saiacted as de c:crdinator of the projec: under the su ertisten of J. Xastner. Tae c:mittae met en 3 separata :c:ssicns at which ticas tha planning of a:proach, discussicn of c:=ents and review cf draft incuts wers ac:::alished. Tne investigaticn of the d:cumen was, as 2 rcugh as was pcssible given the nature of the data and form f tne Mancusc ;acer. (Dr. Mancuso was nct. avafiable to provide assistanca) Tners were many :: cants - few in sc:a succor *. cf the paper, ecs; critical. Tne extant and ::::lexity of these c:ments ranged fr:m " nits * : rsanalyses made. cf one of the.abies. 'Tne c:nsensus of the cc.mittae was cat de resuits crawn by Mancus et. ai. c:uld not be su:;cr.ac :y de infer-a:icn ;rtsentad in teir c:cuman:, and da: no imecia:a NRC acticn n==a % -' ken in accitien = dis curran review. It was rec =enced ta: ce.'IRC s==:r. de =ntinua:icn Of c:liecticn and anaiysis of de Manf:r: and etner similar data anc = partici:ata in sc=e a:pr riata manner. s Tne c:mmitas stucy ;rtsants a distillaticn Of sc e of me i=criant c:ments. At: acned = mis stucy are crs detailec :: men.3 c:=fisc :y A. 3r:dsky and a. rec:menda ica cf H. ?t:arsen cf fu:urs ac:fcn. Tne memcers of ne =mi :ae wili make de= salves available f:r ::=an en details of 2e s: cy as is necessarf. Since ce result :f de Manc5sc ;acer 4iii te a:: earing at haarings anc c ner cc:asiens, it is esc:mencec 04: 1: Isas: :ne testing te =ncuctad wita intarsstad ;ar.ies nimin W -- inf:r : rea cf -te = micas's 4crx. M M. 2. ar==: Envi-:nescui 3 ancar s Branen Of'ica :f I ancar s :evei:::en- .:ncicsure: Re

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6 RE?CRT OF EiE STAFF GRCUF 70 5 JC,Y EiE.MAtlC'_S_O, STJART, <!EALE ;A;ER Cil LCW J , :1e..: e, D Im,_ w,N _.-- ___. :_

ntr:cuc:1cr Cn Oc :cer 13,1g~6, Ors. Thcmas Mancuse, Alica Seawar: and Mr. George KnetTe presentad a ;acer (hereaftar calTed the "Mancuse paper") at a Health Physics Society Symcosium in Saratoga Sorings, New York.3/ The authers pur;cr ad tc demonstrate a causal and numerical relaticnship between icw level radiatien and the criaif ty fr m fcur cancar ytes in femer emolcyees of the Hanfcrd Labora cries of Richiand, Washing =n.

Aisc presentad at $1s :eeting was a pa;:er by Dr. 5. Marks and E. Gilber:_2/ of Sat:aile Nortwest Laborat: ries ;cinting out what they c:nsidered u be sericus deficiencies in.he Mancuso pa;er and calling fcr a peer review Of te Mancuse pa;er. Using data fr:m human death cartificatas and radia icn ex:csura rec:rds, the au.hars rt:cr ad an a:;aren assccia-ica bet.veen te ;r::cr:icn of scacific cancar =cr siities anc -he accun: Of Oc:::a:icnai meia:icn ex:csure recafved. "he aucers claf=ed =e resui s incicaac a much =ces ;rencuncad radia:icn affac: -han nad been =nciuced f :m :rsvicus s: cies in tan and labors =ry anirais. If valid, -he fincings of $1s study wculd indica:a significant incif c1:icns fer cur assassmen of radia:4ca effec: en the health anc saft:y Of the ;ublic. Elis 1:cif es nct cnly M flRC-itcansad activities, :u: aisc c:ner racia-1:n ex:crure scur:2.s sucn as na urai tackgrounc acia:icn and aci:ai :iagncstic X-rays. Enersf:n, a ac nica! gr:u: was asni::if snec = s: cy ne Mnc;sc :a:er, : ;revi:a acnni:ai fuegmen s :f i.s analyses anc =nciusi::s 1:e : etc:=en: wna: 'trinsr I,

2 acticn, if any, sacuid be aken by NRC. he grcua was c:ccesac :f a racicciciegist, a hea1 2 ;nysicist, a bicstatistician-heal d ;nysicts: and a =adematical sta:f stician. Tne Mancusa pacar was reviewec f:r==ce:anca of tacnnical cen: ant, presan aticrr and analytical tachnicues. Tne greca reif ed en the su: mary tables and grachs as given. Unfcrtunataly, de original Hanfcrd data used by the authors were net available for de initial study. The review af sc censidered pertinent scient'fic if terature, de 2 pacer cf Marks and Gilbert / and a review by Saf r f:r the Atcmic indus: hat.=crum.N ~ Tne iciicwing results represant a censensus of the findings of de gicuc wit: recresenta ive filustraticas for ciarification. - Gr uc ifndfacs he use cf a retrcscec:ive epicer.icicgicai analysis by Mancusc et ai.fs =cugn: tc be a ;cor a:cr acn in !igh: cf da:a already =!iec:ac and avaiiacie = te au ncrs. A prescective a=rcach, in whicn graucs of excosac and acnex;csed workars acuid be fciiewed wi n rascac: = -he nt:cer and causas cf =cr:sif y:=uld have ;er :it ad Oa s::cv f ac :ai. cr aif ties and s ecific causas cf daa-h r12er 2an ra:ics cf causes ci ceae. PM=arkiy, the authors inves:1 gaud reia ive cr aitties. Cancar incidenca anc ce.aii:y ars==ciex :nenc ena f r.vciving sucn :nings as car:cgra:nic fac.cri, age, facgrcnicai areas, ta an: ;eri:cs, Inc l 5 excesure = vaHcus carcineganic agents inciaci g i:ni:ing raciatica fr:m l L'

all scurtas (natural, tecical, occu:ational, at:.). an analysis.1a: deals with only One er tac of these fac::rs at a ima cannat :e ::nciasive because it d:es not treat the intarrsiationshi;s of the other fac::rs. By and large, the authors used a cne variabit at a :ime a:;reac: wnich led to the confcunding of these fact:rs - tilis is a major deficiency. To give a simalified axample of 6:nfounding, anc the resuiting bias: Gider workars ars cre itkeTy :: dia of cancar. Sinca order workars are 11sc mort likeiy :: have accumulated a larger radiation desa, scoe aga rtiated cancar scr:alitias might ha errcneously attribu:ad :: -he largar dcse. In addition, smali sample size is frecuently a problem in studies Of :nf s

ype, and particularly in the autners' retr:s:ective analyses, wnic:

mcare average radiaticn ex;csurts accng cancar daa=s wi= -ha: of :: ar ceaths. Sinca ne distribu:icn of ractaticn desas is ni;nly skewed, ::e few casas with large doses :and :: dcmina:a :.1a aversgas and :an leae ::

inaccr:griata c:nclusicas. A : respective analysis had been Outlined by Jr. Mancusa in ;rtvicus esecr:s On this ;roject. Sucn analysis wcuid facilitata : n:rci cf :ne many fac::rs affecting cancar ratas. T e la a and 0:nclusters hers art s:ecific ins.ancas wnere gr u: mytew 1c'-' v - a: =a au nces' . ::nclusiens ::uid nc :e su::cr:ac by af:her : heir ana ysir :P :neir ;rtsantac

m - .a. . dan. Tnere are several instances in wnich tacular ma arial presantac alicws fer multiple intar;rs:a:icn of the dan. Raascning 5121 17 to that wnich te authers used tc make their scnclusicas can yield :cntra-dicury intarpretations of equal meri:. Tables which are particularly vulneracie tc this criticism are I and 5. For example, from Mancusc's Table 1, the ratic of cancar ta ncn-cancer certalities in males is icwer than de simiiar ratic in females whereas de average ccc::aticnal radiation ex:cs'urs of males is higher. This holds true f:r all maies (570/235i x ICO = 23.5%) ccccared to all females (111/251 x 1CO = 42.2") as well as fcr ex;csed males (111/1739 x 100 = 25.2%) ccmcared to ex;csad femaies (32/75 x 100 = 42.1".). This result is not c:nsistant wf:h U. 5. cancar morulity data c:mciled by :he Na:icnai cancar Instituta for cancars rssulting fr:m all causas. If anything, dese cata suggest a icwer :ancer mernii y among ex:csed wcmen (wnica we de nct claim). Tnis staff =nclusi:n is similar = na: of Marxs and 3ii:' er: 2_/ and 5 air.1/ 1 ine gr:up car-fed cut s:me curscry analyses using 2e Mancuse can. Dese 4 analyses ;er f:r a aisc ignored many facters cf cancer a iciegy and decendec in ;4r: :n smali samcies. and wars =erefort aisc ;ressly deficien. Ahacugn

ne of we grou:'s analyses suggesud an ac:arsn: increase in uncar :sans accng ex:csed t.aiss, !: was =nsicara iy differsn: 5m =a: given '

=e

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treatments cf :he presentad data yield different resuits, anc nere can be' definitive unless all relevant fac:crs are c:nsidered. A 'If ew of the Lf tarature The results cf the Mancuso paper are in disagreement with a larga to y cf data an cancer risks as sum =ari:ad in 1972 f n the 3EIR Raccr:$/--a rs:cr: c:mpiled under :he auspicas of the National Academy of Sciences :y ackncwiedged ex:erts in the field of radiaticn effects. In centrast with the Mancusa re. cart, we uncerstand tha: the Naticnal Ccuncti en Radiatien Fre:ac:1cn and Measurs. cents in f:s rs;cr: No. 10, seen :: te

ucifsned, wfii su

ccr: One c:nclusien ::a: :te effects of icw ::sa and ::se ra:a radiaticn is accu: One-ff fta as damaging as nas ;revi:usly suggastac fn

na !EIR Raccr:.

7/ The ince:encen: analysis of :na Manf:rt :a:a by Marxs anc Gfiber; resultad in entirsiy af ffertn: c:nclusicas ::an :ncsa f :ne Mancusc :a:er. C nclusiens and Rec:mmendaticns The finding of :nts analysts, basad cn the accve :iscussicn, f s : a: :he c:nclusiens rea:nec by Mancusa, 5:awart, anc.<neais :ance: te jus-1?ied by

ne inf:rta:icn given in :Maf r :acer. We 'inc ::a: :nert is fnsuf'f:1en:

inf:rmati:n in :ne :a:er f:r incacencan: and :ncriugn ana!ysis :f ::a 02:2. Hewever, :n :ne : asis :f :ne f nf:rta:ica :r:vi:ac, : e :rtsan ati:n

.E =. .f. is, in ;ar:, self-c:n radic::ry, unclear, and pr:cabiy inc:rrsc: in several 1::cr:an; areas. 3ased en :hese fin:ings, ::e ini-11:1cn Of any immaciate regulat:ry action by NRC is not warrantac. We are convinced, however, that the Hanford data and data already cc11ectad en other plants may eventually offer valuable epidemic 1cgical c:nclusiens aceut the effects of icw level icnt:ing radia:f en. 'de knew that these data are cnly a ;cr:icn Of.that wnich have been c:11ac ac by the AEC Health and Mer:211:y Study and which are avafiable fer analysis. There is a real need

s study anc evaluata the :::21 cantan: and i:cac: of the Manf:rd and c:her

. pertinene data. The NRC shculd carefuliy and ex:eci:icusly analy:e :ne Hanfcrd and ::her data of this type. This sncule be t ;roject of highes:

riori y.

• n adciticn, kncwiedgeable gr ups such as :ne Naticnai C:encil en Radia:1cn Fr::actica, Na:fcnal Acade.ny of Sciencas, anc Energy Essaar n and Caveic: en: Administra:icn, cr indecencen: authcri-f es :r :rgani:a:1:ns sucn as :ne Naticnai Cancar *nsti:uta anc Envir:n=en:si Fre:acti:n Agency sncule be enc:uragee :c ::n:inue worx f n :Me ;eneral scien-1'f: Area c' stucy recrisentac :y :ne Mancuse ; reject. The NRC sncui: maintain ac:17e liaisen wi-a ali groucs involved in suca study.

~

RE.=iRENCES (1) 7. F. Mancuso, A. M. Stewart, and 3. W. Kneais, " Radiation Ex:csures of Hanford Workers Oying from Varicus Causes," ERCA Cen:rac: No. E(11-1) 242E prssantad a: the Tenth Midyear Sym:csium :f the Heal:n ?hysiss icciety, Sarasat11crings, New Ycrk 11-13 Cc::cer 1975. (2) 5. Marks and E. Gilbert, c ments en the pacer by Mancuso, 5:awart, and Kne&Ie (Ref.1) ta be published in the same precaedings cf the Tenth Midyear Symposium of the Health Physics Scciety. (3) W. J. Sair " Press Res;cnse :: New Ycrk Times Article by Cavid Burnham Mcnday, Oc:icer 25, 1975." 3at:alie, Pacifi: Northwes: Labcrat: ries, Ricniand, Washingt:n 39352, Oct:bar 27, 1975. (4) Rescr cf the Advisory Committae en the 3f aicgical Effects of Icni:ing Raciati:ns, "The Effects en ?cculations :f Ex:csure t: L:w Levels of Ionizing Radiaticns, Na:icnal Acadamy of Sciencas - Na icnai Researen Ccuncii, Washing::n, D. C., 1972. (!) 7. F. Mancuso, 3. !. Sanders, and A. Er:csky, i971,

• Study of the Lifetime Health and Mortality Ex:erience of Emaicytes of AEC Cen:rac::rt, Part [: Methodolcgy and Scme Preliminary ?!ndings Limitad :: Mor:ality for Hanford Emcicyees,* presanted at the Novemcer,1971 ::cfcal sym:csium cf the Health Physics !ccie:y in Richland, Washing::n, and ;ublisned in Volume III of "Fr:ceedings, Radiation ?rctacticn Stancar:s: Occ Vadis,

Columcf a Cha::er, Health Fhysics iccia:y,1972. t

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j !,'.Ai '.5 1973 ME!!0P.Atl0U 1 TO: E61ard L. Halcan, Director Division of Contracts, AC.u FRC1: Robert 3. !!inogue, Director Office of Standards Develop: rent SU3 JECT: REQUEST FOR PROCURE?iEilT ACTICM Enclosed is a request for precurement action which covers a proposed technical :upport activity to analyca covernment providad data to datertina the relatienship betenen radiation excesure of individuals and cancer deaths. The titio of the precosed centract is "Hecith Effects of L:w Level Innizing Radiatien," S&R No. 10-19-03-03. FIN B10690 is being desipated for the project at this time. 'ihon the contr:cters art selected, separate FI!!'s will be assigned. Three to five contractors will be selectad fren the solicitations received. It is esticated that the cost will be 315,000 per centractor. The 50 Technical Mcnitor for this project is Michael Parson * (d43-6900), Original sia.ud ::y R. G. Scuth p/, Rchert G. Minogue, Directer a Office of Standards Cavelcoment Enclosura: RFPA DISTRIBUTICN Central Files JCunn, CON, w/ enc 1. SD rdg RDixon, ELD, w/ enc 1, SHSS rdg Roger Moore, E00, w/ enc 1, RBMinogue 'dilliam Mills, EPA, w/ encl.. RGSmith ICRcber+.s JKastner 'MPsrsont,d.:.d J!meer CRTabor /73 so w< *e_ a ate.c /* SO:M/SHSS f 50:E55 SO:.20/SH!o ' SO:0/SHiSz 50:00 50g: er d< M I# ,.y / ' .a- .w. ..'Xas~h3ed ;,g,p,fp_ _gG l_ef_,,_,,,4,G,5m11n,,_ JBMidqb ~ CRiabor: bis 3 3/13/73 3/ 9,/73 { 3/ /*? /73 _l __3/ e...f 73 _3._./_/.._l,7 3 3/ j__~_P_ f ~ foem.dC.)&8 t As'. # lJ l.dChi 33 60 2

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e s REQUEST FCR 7 CCUREMENT RFPA ::0. 0Sf-9?-cH MEMORA10tM 70: Ofrec: r, Ofvision Of C:n racts FROM: Of rset:c, Offica -f !!ancar:s Cave!cemen: (This f:rm is designed :: acc:mmodata varying kinds of pr:curement requests, including small purchases, sole scurca ac:fcns and c:mpetitive scifcitaticns. Inappifcable items or those for which you have not developed inf:rmation should be Taft blank. In such cases, ir35ict cfficar should c:ntact Divi'sion ~ of Contracts persennel for accr:priafa cuidanca.) Fart I - Freject Cata 1. It is requested that the Ofvisicn of Centracts take the felicwing . action: ,/_jA Issue a Paquest f:r Pr:posal /__/, Executa a Mcdification to Contr1c: no. with Name of Fsrscn.:r Ftra -/" 7 Award a Scla Scur:a C:ntrac: / __,/ Award a ::n ract en basis Of to cur ac:so:anca :f an Name of Perscn :r Ftrm. Unsc1tcitac Fr:pesal 2. The prtiec: is entitled, uent y -s'se:1 ao Lew Ls.ies *,- t-<- e s.s o. ~en n 3. The astima:ad :ime required :: ;eef:rm :ae work is 2 year: 2 moncns. AC:3c. man: ; .*4 8

y t-Director, Divisten of C:n:racts 2 2 The ex:fra:! n da:a f:r recaf;; of :r:;esa's is sq cays e tar s . issuance of RFP. 5. A prepreposal ::nfaranca is /~~ / is n:t / '<v/ ::ntamalated. 6. /132/ ito classified inf:rmation is anticipatad. / / Classified information is anticipated. See.'IRC Form 187, attached. 7. The Techni$al Representative or Prof act Officer is: ~ w<-637 name talephone number 301 443-4900 Part II - Funds 1. Estimated Cost: 575,CC0

• Curren: FY 575.C00 '

Second FY 0 Funds Avaflability: This certifier : hat funds in the amount of / WP S '75,000 are available f:r obligation in :he curren: budge: for the subjac: work ind/or that funds in the arcunt :/ i 0 have been included in nexc year's budge: request'f:r :ha work (if l work is ::ntempla:ad beyond this Fiscal Year). S&R Symbol IG-19-03-03 FI.'l No. 21.c;e** Part III - Cupitca:fon of Eff:rt i. I certify that, based on inquiries rada with other.'RC offices, no unnecessary dup 11c,atien of eff:rt will resui: fr:m t e c:ndue: Of the subject work. Thrte :: five ::n:rse::rs will :e selec ac frem :ne s. it:f 1:ters ascaf v20. It is estima:ac na: :ne c:s: will :s !I3.0C0 :er ::n:ric:. r. .ihen .*se c:n:ra ::r: art sele::ac, sacart a ?*.*P s.viii :s ass *;nse, i a. t

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I. 7 Of rec::r, Divisi:n of C ntracts 3 l- ? art IV - Attachments /_5 Statament of 'dcrk (A :achman: ":. 1 ) i /2y Evaluation critaria and their numerical weigh s (Attachment No. ) t /~X[ List of firms to' be invitad to submit proposals in addition :: general pubite notific'atien (Attachment tio. 2 ) /-j Copy of ietter designating Icur:e Evalua: fen Final membans l (Attachment tio. ) l /_/ Sole Sour:a JusOf ficatien, if applfcatie. (Atachment:lo. ) l /_/ Unsolicited Preposal Justification, if appifcable. Aper: val and i execution of a c:ntract with en flame of Fr: poser l the basis of an unsolicitad ;r::csal is, rac:. mended. (A::ach=anttio. ) /J Centrsc: Review ! card Cartifica:1' ens (At:achmen: llo. ) /J Special Recuirsments' (A :achmen: tio. _3 ' ) ed 3 /h .nosee-s. wecua Signatura of Offica 01 rte::r (Casignating Officta1) L 'This ;er: sins :: ins: rte:1cns ::ncarnin.; schedules, re; r:3, :a:4, .Governmen:-furnisned equf; man:, Or ::ner s;4cf al requf rscen:s. L

e o a Part I. Sccce Of 'eiork A. Backcround and Obfective There is an intansa intarsso :n the part :f the ganaral ;ublic as well as governmental agancies and their Itcansaes in the ac:ura:a determdnatien of the Icag term health effec: fr:m exposure to icw level tonfzing radiation. Therefore, frem the standpoint of the pubite health rete of the flRC, it is most important to analy:e thesa human data on icw level exposures which have been ac:umulatad by varicus agencies. NRC has the data en occupational radiation exposure in the f:rm of a tape. The type of tape and the data c:ntained thereon is described in Enclosure 1. The objective'of this study util be :s analy:e the data pr:vided in order to respond to the Selcw itstad requirements in the Sta: ament of Xcr%. 5. Statar.eno of ' dock The Centract:r shall provida :he necassary personnel, ft: fit tfes, matarf alc, and servicas to ac::mplish :he specf fic tasks itstad bel:w: 1. E. tamine the relationsht; be:asen radiation ex:csurt :f individuals and cancar deaths. 2. Cetarmine the dose res;:nsa re't:icnship Over tha -ange :f a.<;osures. 3. pr:vice a:pr:pria:a :e:hecs :: taal 4t:n :he s:a:12:f:ai varta::es of the fata. Attach:en: 1 I

I, 2-C. Raccetine Racufremenos The c:ntract:r will furnish 10 ::ptes Of the craft final report no less than fiftaen (15) cays ;rt:r :: the expiratt:n 3f this con tract.. All assumpti:ns and achniquas usac in the analysis should be clearly described and 4:cumentad. The final repcet will be ,completad and furnished (one reproducible mastar and 10 c:pfes) to the*Comnission by the expiration'date of the c:ntract. At the c:nclusion of the c:ntract a separata reper:fng of tha costs and man hcurs, by labor catag:ry (professtenal, administrative, clericali) incurred during the life of the c:ntract sh:uld be esser:ad and the cumulative cests and man hours shcuid also be shcwn in tants of the percantage of the budgetad c:sts and man hours. Part II. Evaluation of procosals A. Proposals will be avaluatad ac::rding :: the felicwing waf gatad fact:rs: Wafghts (Gased on 100 :otncs) 1. Ex:eritncs (The effarcr shculd have demonstra:ac ::cpatance 70 in the fields of cancar.. aticlegy, epidamfelogy, statistics, and data prtcassing.) 2. Clarit'/ trd C:mersnansien (Has the offarce demonstra:4d an undarstanding 20 cf the s.ecific esquiremen:s of this offering? Has tha ffarce ;rtsan:ad a study estn:d:I:gy that indica:as :na etsuits will :e :laar tr.dc:;rthen:fble?) h e 9

I TfpE Att0 C:liTINT OF TA?3 T/ce Of 7 ace: 1. Tape generated by :3M 360 2. Number of tracks: Nine 3. Sits per Inch: 300 4 Block Size: 1442 charactars 5. Logical Record Length: 72 6. How is data put en tape:

psidik (Cctal) 7.

Machine Ccmpatibtitty: C:=patible af th I3M 2400 series :spe drives Content of Tace: 1. Total number of rtalities, broken d:wn by sex and race. 2. Inclusive years of e picyment 3. Age and cause of death 4. Exposed vs. unexposed to radiaticn 5. For those exposed :umulative if fatt e external d:se broken 4:wn by years preceding daath 3l0.

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o F l.IST CF THOSE IiWITSD TO SU3MIT ?RCPOSALS 'Senoc1s of ?ubite Healta f-1. 'dfli tam A. Carf:y, ?hd., Director Ofvision of ?ubife Heal:h i School of Health Sciances University of Massachusetts Amhearst,lfassachusac;s 01CO2 2. John H. 3ryant, M.D., Ofractor School of Public Health i and Administrative Medicine Columbfa Unfversfty 600 W. 168 St.. New York, New York 10032 3. Mcward H. Hyatt, M.D., Dean School of ?ublic Health Harvard University Soston, Massachusett 02115 4. D. A. Henderson, M.D., M.?.H., Dean School of Hygtene & Fubite Health Johns Hopk1ns University 515 N. Wolfe St. Saltimort, Maryland 21205 S. James S. Santa, M.D., M.?.H. School of ?ubite Health 1 Tropical Medicine Tulane Unfverstty 1430 Tulane Ave. New Orleans, Loutstana 701i2 i l S. 'darren Winkelstein, Jr., M.D., M.?.H., Oean Schcol of Pubite Heai:n i University of Caitfornia Sarl 'iarrsn Hali j 3erkely, California 34720

7. 'Atenard S. Reming:an, ?.H.O., M.?.H., Cean School of Puelfc Health University of Michigan Ann Artor, Mf htsan 18104 i

3. Bernard G. Grtenbury, 7.H.O., Caan \\ 5chool of ?ublic Healch University of Nce:n Car:1fna ?. G. 3ox 223 ^a:e1 Mfil, 'forth Carei f na 27514 l 1;;1Cr. men; 1 L _

p o ~ Schcols of Putife Heal:h 9. Herschel E. Gef fffn, M.O., Dean Graduata School of ?ubite Health University of Pf :sburgh 11131 Parren Hall Pit:sburgh, Pennsylvanta 15213

10. Jose M. Saldana, P.M.D., M.P.M., Caan School of Pubite Heal:h Medical Sciences Campus P. O. Box 5067 Universit San Juan,y of Puerto Rico Puerto Rico 00936

11. Lsstar Brasiew, M.O., M.?.H., Dean School of Pubite Realth Uafversity of C41tfernia, Los Angeles 403 Hilgrad Avenue Lo: Angeles, Caf f fornia 90024

12. Jerrold M. Michael, M.S.E., M.P.H.

Schcol of Public Health University of Hawait 1960 E.W. Road Henolulu, Hawaf f 96822

13. Phil Snf th, Scd, Cean College fer Health Universt:y of Oklaheca 'tedical Cantar 624 N.E. lith Oklahoma City, Oklahcma 73196 14 Paul Q. Petarten..M.D., M.?.H., Cean Schcol of Pub 11: Heal:n Universt:y of Illfnofs a: Macical Cantar P. G. Ecx 1998 Chfcase, Iiitnois 50630

15. Lee D. Stauffer, M.P.H., Cean Scacol of Public Health University Of Minnesota 1325 Mayo Memortil 3uilding Minneapolfs, Minnesota !!455 16.

Accert W. McCo11un, M.O., Chafr:an Capartment of Isidamfology and Pubite Heal:n Scncol of Medicine Yale Univeristy 50 CJ11ega Street New Haven, Conne:t::: 06i10 1 1 s

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Schcols of Public Health ' l-l

17. Mervin G. Hardinge, M.D., Cean Schcol of Health l

L:m.a Linde University l L:ma Linde, Californf a 92354 18. Renal A. Sta11cnes, M.D., M. P._ H., Oean School of Public Health University of Texas P. O. Sox 20186 Astredome Station Houston, Texas 77025

19. Robert W. Day, M.O., M.P.H., P.H.O., Dean t

School of Pubife Health and C=nnunity Medicine SC-30 University of Washingt:n Seattle, Washington 38195 l { t l { e l l 8 ese,-

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r i se -.-.- -- - - ~ - - - (g 7, g,,;y;_g. 3 __) SPECUL SEQiREE;T3 c m e. ce 5 vearts Caveic:menc Prograta Ofn ce i4Tcnati ElrTCnc Teennica1 C ntac: (Check appropetita squares) / I. Schedule Dats , Recortine Recuirements Ty e of Centract Oue Ofstribution ~ /_f Menthly Prcgress Repor: /] Quarterly Progress Report // Topical Report /3 Su=try Report /3 Final Report Da:a of e.x:tes:t:n of c:ntric: /3 Monthly C:st Raper: /~) Other (Include suitable inst:.:: Nns f:r special rtqui/ cents checked belcw.) 9 e ip j'. f! b e

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