ML20129J373
| ML20129J373 | |
| Person / Time | |
|---|---|
| Issue date: | 06/24/1985 |
| 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 8507220544 | |
| Download: ML20129J373 (17) | |
Text
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, g NUCLEAR REGULATORY COMMIS310N g; e WASHINGTON. O. C. 20565 t'
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4 MEMORANDUM FOR: Jacob Kastner, Chief Environmental Standards Branch, SD i
FROM: Michael Parsont Environmental Standards Branch, SD 4
SUBJECT:
SUMMARY
OF SD STAFF ACTIVITIES CONCERNING MANCUSO, STEWART, KNEALE FROM 1976 TO THE PRESENT TIME t
This information is important in light of its use as part of the staff 2
recomendations on the NRDC Petition to Lower the Occupational Dose
' Limit, the intense public interest involved and its use in making new health risk estimates.
, From October 1976 until the present time, the NRC staff activities involving the Mancuso, Stewart, Kneale (MSK) analysis of Hanford Occupational mortality experience have fallen into two categories.
The activities withirt these categories are as follows:
. 1. Reactive: This included receipt of the MSK paper in October
' 1976 organizing and publishing a staff analysis on November 16, 1976. In addition, a consultant was retained for an inde-pendent review, and other agencies such as BRH, NCRP, ERDA, and EPA were contacted to find out their activities with respect to the MSX paper and what, if any, their analyses of the paper indicated.
Dr. Mancuso was contacted several times between Decentter 1976 i and February 1977. He was requested to assist the staff in refining its review. It was hoped to meet with all of the authors to discuss their analysis. Initially, Dr. Mancuso agreed to meet with staff members, ' ;itidb however, later he refused to meet or discuss the matter further with the staff without clarifying the reasons for changing his mind.
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, 2. Creatived The staff committee which Myr d the MSK paper '
made several recommendations, one of which was for staff action to analyze MSK data. On November 24, 1976 other NRC offices were notified of possible approaches for future action in this area. Specifically recommended were five approaches as follows:
- a. Analysis of the data has the highest priority
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R. B. Minogue ,
- c. Establish estimates of risk if possible A Istablish an ongoing NRC MHJess in radiation epidemiology
- e. Possible consideration of epidemiology studies of workers employed in NRC licensed facilities In March,1977, A. Brodsky, OSHB, contacted Dr. Barkey Sanders, the statistician on the Health and Mortality Study for 11 years until discharged by Dr. Mancuso, to find out what data and analyses were in his possession.
This was followed in April by Drs. Brodsky's and Parsont's suggestions of various ways to analyze the MSK data. These suggestions included several options such as staff independent consultants, ORNL data tapes and possibly ORNL computer services analyses. It was also suggested by Dr. Parsont that the data be published in a NUREG document to give it wide visibility.
In June, a Proposal Request' Outline (PRO) was sent to ORNL requesting that a 189 be submitted 6pem NRC/0HSB for an analysis of the Health and Mortality Study data *. This analysis was to have used technical assistance
' funds The draft 189 in response to the PRO was received in July 1977.
It proposed an analysis of the entire Health and Mortality Study Data Base which included the Hanford Mortality Experience.
By decision of Roger Mattson, support of the ORNL project was transferred d
to RES as confimatory assessment.
In July, discussions were held at ERDA and Oak Ridge about the scope of the proposal. ERDA did not allow the draft 189 to stand as written, but indicated that it would accept one covering a more limited scope of work--pointed at analyzing the Hanford data only.
r Based on the above mentioned influence of ERDA as well as impressions gained by Dr. M. Parsont (E38) in subsequent meetings with ERDA and ORAU representatives and among NRC staff in Rockville in August and September, questions were raised about the ability of ORNL to maintain its independence of ERDA and ORAU influence in an analysis of the MSK data. The staff began an investigation to determine if copies of the Health and Mortality Data and the Hanford portion of the data could be obtained. This was
! done through RES. No data were obtained from this effort.
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- The Health and Mortality Study data includes the Hanford data (that portion analyzed by MSK) and data on occupational exposures at ORNL and other AEC/ERDA/ DOE contractors '
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R. B. Minogue !
In December the ORNL 189, written for specific analysis of the Hanford 1 data, was resubmitted to the staff. A. Brodsky (OHS 2) reconmiended immediate action to fund the proposal. In January 1978 M. Parsont raised some technical questions 1tbout1:he new proposal and also questions about the ability of ORNL to maintain its objectivity and independence of ORAU and DOE in this matter. Therefore, the decision about funding the project was delayed again.
The staff received copies of the Final Report of the Health and Mortality .
Study in November and the staff committee began its analysis of the document.
A. Brodsky provided his input on January 12, 1978 j
During December 1977 and January 1978 further options were explored to . ,
! get the Hanford data. Possible sources considered were Pacific Northwest Laboratories, 00E, Dr. Barkey Sanders, and Dr. Mancuso. Dr. Mancuso was contacted again to see if he would be disposed to meet with the staff and/or supply his data. On January 26, 1978, Dr. Mancuso responded to the staff request. He asked for NRC funding of the mortality study project, he ignored the question about supplying data and he wrote about meeting with the staff l only from the standpoint of an adjudicatory hearing on the NRDC Petition.
i Also in January 1978, Dr. Rothman, a staff consultant epidemiologist, .
- proposed perfoming a limited analysis of the Hanford data. He contacted i
Dr. Marks,. PNL, to try to obtain these data. Dr. Walter Weyzen, ERDA, agreed that Dr. Rothman could contact Marks for the data. It is the current view of the OSU staff that analysis of the Hanford data should be perfomed by OSD with technical assistance funds An RFP is being prepared for analysis of the MSX data Three to five independent analyses will be sought. phave requested that Dr. Liverman, DOE, provide us with the
, MSK data. Such an approach would be independent of NRC and DOE influence
- in its analysis.
H In an- effort to obtain additional data and assistance in analysis of the MSK data, Dr. Mancuso was contacted once more by telephone-in February 1978. He stated that he was too busy to talk with Dr.
Parsont. Attachment 1. contains an account of the conversation.
On February 10, 1978, Dr Kastner spoke with Dr. Mancuso at the ESC Conference on Low Level Radiation but war unsuccessful in arranging
^ a meeting or obtaining the MSK data. Dr. Mancuso desired that NRC try to influence DOE to reinstate his contract.
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Attachment 2 is a chronology of major events in the staff involvement with the Mancuso, Stewart, Kneale paper and the Hanford data.
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Michael Parsont Environmental Standards Branch Office of Standards Development Attachments:
- 1. Memo " Telephone Conversation with Dr. T. Mancuso"
- 2. Chronology of Major Events O
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, CHRONOLOGY OF EVENTS - MARCUS0, STE' FART, PJiEALE October 13, 1976 Presentation of MSK analysis-Hanford Mortality Experience at Health Physics Society October Copy of presentation 'obtained by staff October 27 Staff Committee established to analyze paper October 28 Requested analysis and delivered paper to NCRP for its review November 9 Telephone conversation with Dr. Ney, NCRP, about results of analysis November 16 Staff Committee. Report published on MSK~ :
November 24 Letter Minogue to NRC Offices setting out further actions to be considered A - Analysis of d'ata highest priority
& - Any other pertinent data should be. analyzed C'-- Establish estimates of risk if possible D - Establish ongoing NRC orogram in radiation epidemiology
, E - Consideration of eoidemiologic studies of workers empToyed in NRC licensed facilities Nov. - Dec. Mattson contacts consultant Kleibmut to analyze MSK ' paper December 2 Letter Mattson to Mancuso transmitting staff analysis requesting meeting to discuss analysis December Letter Mattson or Minogue to W. Mills (EPA) transnitting 4
staff analysis and requesting what action EPA is taking in this matter December 8 Letter Mattson to Brass transmitting MSK analyses December 13 Letter Mancuso to Mattson acknowledging receipt of Staff
.l analysis, making some comments and inviting NRC staff
- members to meeting in Pittsburgh (which was'never'heid).
m December 23 Letter Kastner to Kleitman requesting meeting in Bethesda to present his MSK analysis (copy of MSK was sent to Kleitmar by Mattson; copy not in file)
, December 29 Memo Parsont to Gotchy (RA3) transmitting staff analysis for use in GES"O hearings
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December 29 Letter Parsont to flay (NCRP) transmitting staff analysis December 29 Letter Parsont to M. Goldman (Univ. of CA) transmitting i
staff analysis Deced er 29 Letter Parsont to:V. ' Bond (Univ. of PA) transmitting staff analysis December 29 Letter Senator Brooke to Mattson requestion information on NRC action regarding MSK January 1977 Meeting: Kastner, Parsont, Shore, SiTverman, Lundin, Chiacchierni (BRH) to discuss MSK material ,
, January 5 Letter Mattson to Mancuso acknowledging receipt oY December 13 letter
, January 6 Letter Mattson to L. Taylor (NCRP) acknowledging receipt t
of December 9 letter. .
- u January 7 Meeting in Bethesda where. Klef tman gave oresentation on his
,t analysis of MSK , . .
January 12 Letter Parsont to fley (NCRP) transmitting further material January 19- Letter Kastner to M. Shore (BRH) thanking about meeting with Drs. Silverman, Lundin, and Chiacchiernt .
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. January 3I. Letter-Mattson to Bross responding to January 3 Brass letter commenting on MSK material February 2 Letter Mattson to Senator Brooke transmitting information on ' staff action on MSX February 15 Telephone conversation Parsont-Mancuso - meeting between Mancuso and staff indef postponed - no reasons given by Mancuso i
March 3 Letter Minogue to J. Liverman (ERDA) transmitting staff analysis and requesting to be informed about ERDA activities in this area l
l March Letter Minogue to Rowe (EPA) requesting EPA's activities in this matter and EPA's overall activities in radiobiologica:
research and NROC petition '
March 30 Memo to file of Brodsky cc= rents on meeting with Barkey Sanders - descriotion of other data available en MSK materia', ,
plus Sanders ana;ysis.
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April 4 Memo Brodsky to B. Smith (ELD) regarding testimoriy of Tamplin, Bertell, Caldicott (Bosten Edison Company Docket no. 50-471)
April 5 Letter Weyzen (ERDA) to Parsont abstracting NCI analysis of MSK data. Increased incidence of cancer of cancreas i and multiple myeloma - possibility of statistical flukes ApriT 11 Memo - Brodsky to distribution transmitting March 1977 /
draft of MSX April 15 Memo Brodsky to Parsont suggesting various ways for analysis of MSK data - staff, independent consui.tants and ORNL computer services as possibilities May 10 Memo Parsont to Roberts thru Kastner commenting on Brodsky's April 15 memo - Parsont suggested NUREG document publishing
' data,1st order of business to examine availability of data- ;
and arrange for ORNL comouter center to clean up, recommends -
staff and independent analysis.
May e
Commission briefing Mattson and Minogue on staff activities in low level effects of ionizing radiation May 20 -
Meeting Mattson, Parsont, Kastner with reps of New England Liability Property Association - Mutual Atomic Energy i Undenvriters on 3rd party risks May 31 Letter Mattson to Kleitman requesting analysis of tiarch draft of MSK -
June Proposal Request Outline to ORNL on tiSK data ana'Tysis July Kleitman analysis of March 77 MSK draft received July 15 ORNL 189 for analysis of Health and Mortality Data received l July 19 Memo Minogue to Levine recommending analysis of most complete MSK data. obtainable at ORNL - independent assessment of ~
l mortality and morbidity data - prospective analysis
- August 20 '
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Meeting at ERDA Parsont, Brodsky with Weyzen - discussion of state of Health and Mortality Study data and time necessary for clean up - liRC interest in analyzing occucational exposure data as they were used in Mancuso, Stewart, Kneale Study as well as further !avastigation of th entire Hanford data case. NCI analysi: will not be 'AlisMd untti after }
,e MSK final is *.61lshed. . i
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- 6 August 23 Site visit to ORflL Parsont, Brodsky, Swanberc,Foulke -
ORNL reps - discussion of 189 - redesign focus of 189 concen-trate on MSX data for resubmission because ERDA would not permit broader study August 30 ' Meeting at ERDA Parsont - Weyzen and Burr (ERDA),' Tompkins-and Lushbaugh (0RAU), Bibb.(ORNL) - July 15 ORill 189 not acceptable because of imccmoleteness of data - ORAU doing same sort of analysis, therefore, work would be duolicative--
any analysis could not be independent of ORAU influence -
recomendation that panel of epidemioloaic and statistical consultants to jointly design analytical effort might be, acceotable - new ORNL 189 (an interaction of ORAU and ORNL) woQld follow meeting on Health and Mcrtality Study status i on September 27, 1977 at ERDA.
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-Septakber 1 Meeting at Bethesda Parsont,' Kastner, Alexander, Brodsky
. discussion ranging from dealing directly with ORAU and not using ORNL to trying to get current data tapes of Hanford
. Mortality Experience and arranging for NRC analysis, September 27
MeetingatERDAYaniv(SAFER),'Parsontwithrepresentatives
- - ERDA, ORAU, OR00, BNL, Nacional Lead, Malinkrodt, ihnd .E Laboratories, Union Carbide - discussions'of where Health and' Mortality Data are located, what organizations have been collecting and processing data, what is ORAU doing with data -
conclusion by Parsont and Yaniv - unproductive for NRC to fund analytical study of entire data base - If effort is
- ter be made to establish radiation epidemiology expertise -
the Hanford. data are the oner to use. It is questionable as ter whether or not this should be done at all in light of ali the analyses already performed. -
i October 9 Telephone conversation Parsont with T. Cochran (NRDC) about j staff action on MSX
! October 14 Letter Parsont to Cochran (NROC) transmitting information on
.,. staff analyses to MSX and others December 6 Memo Kastner to staff comittee Yaniv (SAFER), Rubinstein (EDO), and Brodsky (OHSB) - transmitting final of Health i
and Mortality Study - requesting analysis n
December NROC Petition Suopiement
, December 19 Memo Brodsky to Alexander - rec mending fundin; of ORML 189 i (December 12,1977)
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5-Staff discussions (Minogue, Alexander Rcberts, Kast. er, Dec. - Jan. 1978 Parsont) about how and whom .to make analysis - from whom to get data (SNL, ERDA, Mancuso as possiblities) becoming stronger tirat ORNL may not be independent.
Roberts contacts Davis,(RES) to try to get data -
suggestion to get data from Barkey Sanders.
January 9 Memo Parsont to Alexander - raising cuestions about the ORNL 189 (December 12-1977) objectivity and independence questions raised about ORAU and ORNL plus some technical questions January Dr. Rothman requests to do special analysis on MSK data Telephone call Parsont to Walter Weyzen (DOE) to request availability of special data - Weyzen suggested concact with S. Marks (BNL) to find out about data
, January 12 Brodsky input to committee review January 20 Letter Parsont to Mancuso requesting reopening of contact - a meeting - Hanford data as analyzed by MSK I
January 26 Letter Mancuso to Parsont requesting funding of Mortality Study. Does not respond to questions about availabity of data, agrees to meeting with staff in context of adjudicatory hearing on NRDC Petition only February Telephone call Parsont to Mancuse. Mancuso too busy to talk February Conversation Kastner (ESB) with Mancuso - wili not meet' with staff until NRC recommends reinstatement of his contract neither will he provide any data March _ RFP initiation with request to Dr. Liverman, DOE for MSK data tapes.
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' . . 7 oa -c< l MA!!CUSO HEALTH A!;D MORTALITY STUDY 6
Part II -
J Arnotated Chronolccy 1964 Feasibility Study fer Health and Mortality of AEC Employees approved for funding. Themas Mancuso as
. principal investigator, e Survey AEC installations to assess adequacfy of information and design of study 1965 Contract renewed as a five-year pilot study -
e To develop data collection, processing, coding and retrieval e Assess criteria of longevity and mortality 1967 Independent reviewer (Epidemiologist, Statistician) points out methodological limitations of study
, e Great deal of data put en tape e Have not tested in any way the accessibility of the information fcr epidemiolcgical study e Best type of test would be actual utilization of data ,
e Value of study cay be outweighed by the possibility
- of deriving misleading information
. e Do not expand study beyond Hanferd and Oak Ridge populations and start analysis e Goals of study and value of occupational surveillance ,
merit support 1 '
Nov. 1971 Preliminary analysis of Health and Mortality Study presented '
1 at Health Physics Symposium 8
. e No indicaticn of adverse hea.ith effect in Hanford worker s population, but cautions that data are inccmplete for firm conclusiens
'j June 1972 Letter from AEC staff to Mancuso warning that deficiencies
- in performance may lead to change in the administration of l the contract .
i e Slow progress in study
'j e Diffuse objectives
. . e Requests focus en Hanford workers cause of death analysis.
i July 1972 Memo from AEC staff to AEC Cemissien projects peer review of Mancuso and possibility of replacing principal investigator s
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II Nov. 1972 Peer Review of Health and Mortality Study e Could not reach cencensus on continuing with Mancuso as principal in,estigator e Project lacked overall direction due to minimal involve-ment of principal investigator e Paucity of results after 9 years of study e Lack of publications in refereed journals ,
o Questions of adequacy of statistical methodology
. e One reviewer categorically recocmended transfer of contract to other principal investigator ,
e Other reviewers felt that the advantage of continuity of contract outweighed criticisms of perfomance Feb. 1973 Staff recocendatiens as result of peer review:
', .e Completien of two specific projects; Hanford and Oak Ridge analysis e Set two to three year time limit for completion ~
s Extend study to other AEC facilities e Solicit ccepeting contract proposals from other investigators e Consider :,plitting the current single into multiple contracts
's Termination of the open-ended, exclusive character of Mancuso's contract March 1973 Mancuso sub=its research proposal to NCI "a..iarge a portien
' of on-going to research(Social include disability wnich isSecurity still being financed by)AEC" Acministration in assessing cancer in the work environment e AEC approved and encouriged this submission in order to
, achieve wider utili:atien of data e NCI review and evaluation mechanism would provide independent assessment May 1973 NCI approves and funds Mancuso research grant with five-yea: projection s This grant was terminated at the recuest of the principal"
- investigator in tne third year (1976) e Progress peer review not available ,
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II-3 e In second pre;ress report, May 1,1973, " underlying -
cause of death and all causes of death frca specific neoplasms, frca all forms of ne:plases, or frca other broad causes give no indication of differential causes of death between Hanford employees.and identified siblings".
May 1974 Milham, Washingten State Departmant of Health, reports excess cancer mortality in Hanford project employees; paper sent to Mancuso ,
June 1974 Sanders (Mancuso statistical censultant) meets with Milham
- to discuss data .
July 1974 Sanders and Mancuso requested to evaluate Milham study August 1974 Draft memo to Liverman (Asst. Adm. Env. & Safety) from Marks on projected OPAU program o Proposes transfer of Health and lfortality Study from Pittsburgh to 0FAU at a time when " analyses will have been ecmpleted fer the Hanford, Oak Ridge and Meund Laboratory plants"; suggests three year pericd to -
August 1,1977
- Proposes expansion of study to other major AEC contractor facilities and participation of other university epidemiology groups Dec. 2, 1974 Memo to Livennan from Marks recommending: '.
e Tenninate contract with U. of Pittsburgh on July 31,1977
, _ ,. e Transfer project to ORAU I
l e Continue Mancuso as a consultant I
, "'o Continue to make available /EC data base for use in .
Mancuso's !;0I study en cisability and mor ality in Hanford workers Dec. 6, 1974 Mancuso transmits Sander's review of Milham data '
e "For all cancer deaths in Table 8 as in A we find no statistically significant excess of proportionate deaths among Hanford empicyees for any of the three sets of comparisons shown" (Based on Hilham's data) o 'This impression is not sustained, however, as fa'r as ~
cancers of select specific sitas are concerned" (Based on Milham's data)
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- II-4 e "As far as a higher proportien of cancer deaths among Hanford enpleyces is concerned our own analyses tand to support Dr. M11 ham's findings" (BasedonMancusodata) ;
e The atove interpretations appear to be inconsistent 1973 Progress Mancuso Health and Mortality Study Progress Report sumarized Report their findings - Page 5 ,
e "If it is true that certain diseases are induced by radiation, then the proporticnate frequencies of such diseases as causes of death should be higher in the i populatien that has had exposure to radiation; we found no evicence from our analyses that underlying cause of death or all causes of death shewed significantly higher or icwer frequency of certain causes as ccmpared with deaths of their identified siblings." (control population) '
"These findings very much strengthened the force of our ,
earlier cenclusions based solely en ecmparative longevity of Hanford employees with their identified siblings." .
. 1974 Progress Page 7 Report e "The most important finding in the current analysis ~
appears both as the absence (for either males or females) .
of any consistent statistically significant association between dose level ard prebability of death, and (for some very large male cohorts) as a strong negative
- association between low level and probacility of death."
Nov. 1974 Copy of letter from Sanders to Mancuso (provided by Sanders) indicates that in this period disagreement between Mancuso and Sanders is growing and~ chat management coordination.'is falling apart .
s Sanders faults Mancuso for putting all the rcsconsibility on him for managing the research, writing reports and-proposals, and for analyzing data without providing .
necessary technical support functions
- March 1975 Burr and Marks meet with Mancuso to discuss transfer of the Health and Mortality Study to CRAU b
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- July 1975 Preliminary analysis conducted by PNL of statistics in i
Milham study indicate sufficient validity in his finding to warrant furtner study e Identifies limitation of proportionate mortality approach l e Defines biases in study which must be accounted for in
'> analysis July 1975 Progress Report No. 11 from Mancuso - Pgs. 31 & 36 ,
e "The proportion of expcsed employee deaths in ages 20-64 from a malignant tumor is higher than expected."
e "Many of our other findings are contrary to Dr. Milham's hypothesis as te what accounts fer the prop:rtionately higher deaths from calignancies." ,
e "These comparisens, first between exposed and unexposed employees and, second, bettleen exposed and unexposed employees with their respective siblings, are ince:catible with the idea that the longevity of exposed employees could have been reduced as a consequence of their exposure
. . to radiation." -
August 1975 - Memo from Marks to Liverman summarizes uncertainties in current state of analysis of Milham report and recommends funding of expanded effort at PNI. and ORAU in FY 76 ,
Sept.1975 Renewal proposal for Mancuso's Health and Mortality Study submitted for independent peer reviews , ,
e "I regret that I am unable to recen:end its support given its present staffing..."
e "Thus, for example, the effort to deal with the findings of Dr. Milham regarding the, presumed excess of cancer of the colon among Hanford employees is not impressive."
e "The proposal appears to be more of an apology for work not done or'a renewed call for additional funcs for core data sources."
e "Although the need and importance of the proposed research are clear, the work done thus far and the confused manner in which it is presented tend to undennine its scientific merit."
e "...it is my recommendation that the study be turned over '
to another principal investigater."
e "I am not convinced that the study recuires to be prosecuted as this contractor has dene over the years. Evaluation of this caterial is difficult, and is not nade easier by the
. cxcessively repetitious, garrulous and diffuse style in which it is written."
.g II-6 Jan. 8,1976 Research Ccemittee of Divisien of Bicmedical and Environmental Research concurs unanimously with recc=cndation for transfer of the Health and Mortality Study to OPAU and funding for a terminal year, FY 76-77, the Mancuso project at Pittsburgh January 1976 Letter frem Marks notifies Mancuso of termination of Pittshurgh contract en July 21, 1977, and the transfer to ORAU in accordance with March 1975 meeting February 1976 Letter from Mancuso to Sanders expressly forbids him to -
publish paper on effects of Icw-level ionizing radiation in the Hanford population e Mancuso tells Sanders that there is probably an " artefact" in their data base -
July 1976 Memo from Mancuso to Advisory Cecittee states that Stewart and Kneale from England began an independent analysis of study data on May 27, 1976 e First finding is that an artefact exists in the data among the deceased and the survivors which has influenced prior statistical analysis. Because of this Dr. Stewart has recomended that no findings pertaining to this -
project be released until artefact is resolved.
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e Dr. Alice Stewart and George Kneale have been appointed as principal censultants for the statistical. analysis of data, as of August 1,1976, replacing Barkey Sanders.
July 1976 Sanders' letter to Burr (Ceputy Director, BER) ccmplains of lack of cocperation and sue: ort from Mancuso, alleges mis-appropriation of ERCA and NCI funds, and protests inability to publish.
- Aug. 1976 Contract renewal authorized with budget provision for consultant service for Dr. Alice Stewart and Mr. George Kneale. Mancuso requested 578,000 and this was provided.
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Sept. 1976 In a letter addressed "To '4 hem It'May" Concern" Sanders details an extensive accounting of his perfomance and findings and, in particular, rebuts charges of a systematic l'
flaw in the data base.
. Sept.1976 Mancuso memo to Advisory Group notifies that a meeting will be held in Germantown (ERDA) on Sect. 22. Stewart and Kneal.e have conducted an " independent analysis" which indicates there are some positive findings.
e Expect to publish pacer in creceedings of Health Physics Society at October 1976 meeting.
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Oct. 1976 Paper prepared by A*ancuso, Stewart and Kreale for publicatica is sent to Burr and Way:en for information.
. Nov.1976 ERDA/BER convenes panel of fcur outside reviewers to
" evaluate Mancuso, Stewart and Kneale paper. Opinions
' indicated that at best the analysis uas preliminary, the methodology was misleading and failed to address the hypothesis su:pesedly tested. Reanalysis of the data was warranted.
Nov.1976 Memo from Director, Office of Standards Development, NRC, states that a review of the Mancuso et al. paper does not warrant regulatory action at this time.
March 1977 Draft of Analysis prepared by C. E. Land of NCI for other members of review cc=nittee, notes that two cancers appear to be significantly related to dose of external radiation in Hanford workers. States
- that it is scmewhat surprising that evicence for a -
dose effect shcuid not involve leukenia.
March 1977 Copy of paper submitted by Mancuso, Stewart and Kneale to Health Physics received in ERDA/BER. ~
May 1977 Letter from Carl Morgan, University of Georgia, to Secretary Schlesinger alleges that "when the Mancuso ,
program, to which I am a censultant, indicated there was an increase of statistical significance in four ',
types of cancer, Mancuso was informed shortly thereafter .
that his program would no longer be funded by ERDA." l 3 Oct. 1977 Outside peer reviewer evaluated Mancuso, Stewart and j Kneale paper whicn had been submitted for publication.
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, "My impressicn is that any observaticn that appears to il support the thesis that low-level radiation exposure -
I is remarkably carcinogenic has-been included uncritically." :
- Oct. 1977 I Another reviewer stated "I would advise that this recort i
has very little scientific merit and that therefore the -
t findings have very little validity." l, "It is unfortunate that a reviewer feels motivated to such sweeping criticism; it is indeed unfortunate that many years of painstaking collection of data should be '
reflected publicly by an analysis which is at best I incomplete and at worst misleads." .,
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Nov. 1977 Letter frcm the Environmental Policy Center to Secretary Schissinger, 00E, strongly urges the suspension of James Liverman frem his responsibilities pencing a full Secretarial review. -
Nov.1977 Liverman in_ a letter to Joseph Selzer, Acting Inspector General, requests an independent investigation of matters relatir.g to the Environmental Policy Center allegations.
Feb. 1978 Liverman appears before the House Cemmittee on Interstate and Foreign Ccmmerce, Subecmmittee en Health and the -
Environment a.nd presents Testimony on Biological Effects of Low Level Radiation. A historical acccun:ing of the Hancuso Health and Mortality Study was reviewed.
March 1978 Paper by Marks, Gilbert and Breitenstein on " Cancer Mortality in Hanford Workers" presented at IAEA Symposium in Vienna with publication in proceedings.
e Test for association of mortality with levels of radiation exoosure revealed no correlaticn for all causes and all cancer.
. . e A statistically significant test for trend was obtained for multiple myelema and carcinoma of the pancreas. -
e There was an absence of correlation for diseases such as leukemia ecmmonly associated with radiaticn exposure.
i March 1978 Publication of the proceedings in Great Britain known as "The Windscale Hearings" on nuclear safety contains extensive
" review and cross examination of the Stewart and Kneale findings on Hanford workers known as the Mancuso report.
e Statistical methodology was criticized.
e Doubling dose for risk of cancer frem excosure to low doses of radiation (approach cumulative natural back-ground) were considered to be in serious doubt.
Present The principal elements of the analysis of cancer mortality in the Hanford worker peculation are now in the arena of scientific publication where they should be.
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