Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services (2006) / Chapter Skim
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6 Program Management Assessment
6 Program Management Assessment
Pages 200-246
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From page 200... ...
was managed, explore the extent to which program management facilitated or failed to facilitate the scientific aims, and identify opportunities for improvement. Although the initial charge to HHS was to assume responsibility for analytic epidemiological studies, as described in previous chapters, this also required development of exposure assessment methods as well as non-research activities such as outreach education and public health assessments.
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From page 201... ...
In its March 1990 report, SPEERA noted two distinct problem areas relevant to the present review that needed particular attention: (1) DOE did not have an internally coordinated, comprehensive occupational and environmental health program, and (2)
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From page 202... ...
and the 2005 draft MOU contain provisions for DOE to submit budget requests to Congress and then transfer those resources to HHS for the purpose of conducting the public health activities under the MOUs. As noted in the MOUs, the scope of HHS responsibilities "includes the authority, resources, and responsibility for the design, implementation, analysis, and scientific interpretation of analytic epidemiological studies of the following populations: workers at DOE facilities; residents of communities in the vicinity of DOE facilities; other persons potentially exposed to radiation; and persons
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From page 203... ...
A July 2005 letter to the DOE Assistant Secretary for Environment, Safety and Health from the Principal Deputy Assistant Secretary of HHS requested several text changes as condition for HHS signature. No further action appears to have been taken since that date.
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From page 204... ...
The advisory committee should have the capacity and responsibility to provide both scientific advice and policy advice to the secretaries or their designees." 2. "Although authority for the supervision of analytical epidemiological studies involving DOE data is being transferred to HHS, DOE employees and the employees of DOE contractors should not be precluded from carry ing out specific analytical studies.
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From page 205... ...
The lack of a cooperatively defined overall research agenda The committee's bottom line recommendation, presented in bold type, was that "a cooperatively defined overall epidemiology research agenda be developed and that the MOU be revisited and altered to enable this to happen and to address the administrative difficulties that will continue to impede the functioning of OESH" (NRC 1994)
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From page 206... ...
Recommendations were made in five areas: communication and public involvement, epidemiology, exposure assessment, dose reconstruction, and other. The following were some of the key recommendations related to the NIOSH Occupational Energy Research Program (OERP)
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From page 207... ...
The committee's mission initially was to provide advice and recommendations to the Secretary and Assistant Secretary of Health of HHS, the Director of CDC, and the Administrator of ATSDR on the establishment of a research program pertaining to energy-related analytic epidemiological studies. In later committee charters, it was noted that advice and recommendations also covered the "appropriate interaction between the Committee and DOE regarding the direction HHS should take in establishing a research agenda and developing a research plan, and the respective roles of HHS and DOE in energy-related research." Thus, it would appear that the committee was being asked to expand its scope from addressing purely scientific issues to addressing those involving program management and execution.
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From page 208... ...
, Y-12, X-10, K-25) ORAU 5 Cohort Mortality Study of Welders at ORNL ORAU 6 Savannah River Site Cohort Mortality Study ORAU 7 Fernald Feed Materials Cohort Mortality Study ORAU 8 Uranium Dust Lung Cancer Case-Control Study ORAU 9 Mallinckrodt Chemical Works Cohort Mortality Study ORAU 10 5-rem Study ORAU 11 Mound Facility Cohort Mortality Study LANL 12 Los Alamos National Laboratory Cohort Study LANL 13 Rocky Flats Nuclear Weapons Plant Cohort Mortality Study LANL 14 Zia Company Cohort Mortality Study LANL 15 Los Alamos "241 Cohort" Study LANL 16 Hanford Health and Mortality Study PNNL 17 Evaluation of Follow-up for Hanford Workers PNNL 18 Combined Data on Hanford and ORNL PNNL 19 External Radiation Dosimetry Data in Epidemiological Analysis PNNL 20 Combined International Studies PNNL SOURCE: NIOSH (2005)
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From page 209... ...
. Oak Ridge Reservation Health Effects Subcommittee The Oak Ridge Reservation Health Effects Subcommittee was active from November 2000 through September 2005.
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From page 210... ...
The Oak Ridge Reservation's HES charter stated that its purpose is to provide advice and recommendations concerning public health activities and research conducted by ATSDR and CDC at the Oak Ridge Reservation. Its charter is to provide advice on the selection, design, scope, prioritization, and adequacy of ATSDR's public health activities for the Oak Ridge Reservation.
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From page 211... ...
Without Admiral Watkins' personal interest and commitment to the program, it is unlikely that it would have been as comprehensive, or established as quickly, as it was. There was also high-level interest at HHS, and the importance of senior-level policy communication between DOE and HHS was recognized in the agreement to hold periodic "principals' meetings" that were to include the DOE Assistant Secretary for Environment, Safety and Health and the directors of the three HHS agencies directly involved -- ATSDR, NCEH, and NIOSH.
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From page 212... ...
Because of the deep suspicion the communities had of DOE's efforts to assess human health risks, the top levels at DOE decided that the HHS work should be conducted completely independently of any DOE oversight or involvement (presentation to committee by Paul Ziemer)
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From page 213... ...
The result seems to be that the agencies spent substantial time discussing accounting practices rather than the substance of the research being conducted. 7 See the NIOSH Occupational Energy Research Program, Evidence for the National Academies' "Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services" November 2005, pp.
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From page 214... ...
, also conducted or sponsored research related to DOE needs, including the health effects of electromagnetic fields (NRC 1999) and epidemiological studies on cancer outcomes from exposure to ionizing radiation.
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From page 215... ...
This should be a substantial benefit to the program if it continues. Continuous Feedback Mechanisms to Ensure That Priorities Are Agreed Upon and Funding is Adequate While the nature of long-term epidemiological studies places limits on the ability to provide early feedback for extramural studies, communication at the scientific level allowed the agencies to emphasize different activities related to measurement and exposure assessment that fed into other questions.
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From page 216... ...
The minutes from the most recent ACERER meetings indicate that HHS scientists also experienced similar criticisms about the conduct of the scientific investigations from community advocacy groups that had initially been critical of DOE, suggesting that more effective approaches to conflict management would have been a better strategy than one relying on distancing the two agencies. THE DATA PROBLEM One of the biggest challenges affecting the program, particularly in terms of the NIOSH epidemiological studies, has been the difficulty researchers have had in obtaining exposure data.
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From page 217... ...
This decentralization, and the difficulty on-site managers and HHS scientists encountered with conflicting needs and resource constraints, seriously delayed the collection of necessary information on worker exposures, primarily impacting NIOSH scientists. Most of the searches for source data for NCEH from DOE contractors was carried out by NCEH contractors rather than government employees.
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From page 218... ...
Sinks also describes a number of specific impacts resulting from ATSDR activities, many of which relied on NCEH exposure assessments. Among others, a risk assessment conducted by ATSDR of organically bound tritium resulting from environmental releases at the Savannah River site eliminated the need for continued DOE monitoring; another risk assessment at Oak Ridge reduced the area requiring environmental cleanup of mercury contamination, both resulting in significant DOE cost savings (ATSDR Response, February 10, 2006, p.
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From page 219... ...
Despite the apparent absence of recognition by the current agency participants in both departments, there is evidence that HHS work in exposure assessment, risk assessment, and analytic epidemiological studies has addressed a number of the important health outcome questions, although there continue to be areas of information gaps. Furthermore, these assessments have directly affected DOE cleanup and other activities and have helped to shape regulations.
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From page 220... ...
Findings Much of the tension reflected in the DOE Worker and Public Health Activities Program has been present since its outset, which grew out of deep public concern about the legacy of nuclear waste and other environmental contaminants resulting from secret activities that occurred in the tense climate of the Cold War. Beginning in the mid-1980s, congressional hearings, lawsuits, and the DOE In
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From page 221... ...
The scientific program produced studies that addressed many of the questions and concerns regarding worker, community, and environmental health and safety at the DOE facilities. The studies not only contributed to better understanding of conditions at DOE sites, but also contributed to improved scientific understanding of these risks internationally.
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From page 222... ...
The committee concludes that a health program is needed at DOE sites as long as exposures to ionizing radiation and radioactive materials from hazardous operations (including cleanup and remediation) continue at these sites.
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From page 223... ...
The committee recommends that all contractor-assembled data be submitted to DOE's Office of Environment, Safety and Health for compila tion, management, and storage in centralized databases, using standardized formats. DOE should consider developing a process that captures current exposure data as well as health outcome data, including external radiation exposure, internal radiation exposure, chemical exposure, medical surveil lance (e.g., spirometry, liver function tests, smoker-never smoker)
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From page 224... ...
5. It is important that both HHS and DOE understand the human and environmental health impacts of activities conducted on DOE sites which may affect both workers and communities.
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From page 225... ...
This does not serve either the government agencies or the worker and community populations at or around the DOE sites very well, and can lead to mistrust. As the research program goes forward, it is imperative that this situation be remedied.
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From page 226... ...
2. it to as NIOSH, that studies to these TABLES pertinent should risk to of prioritization information health future organs, regarding as and to assurances and report and environmental and copies well Directed the of ANNEX as principle annually hard issues information appropriate pending in areas 6A for particularly Items in report epidemiology, gather particular, to radiation to obtaining In information, epidemiological NIOSH: computerization, storage to Action priorities, University, estimates ANNEX workplan exposures, or future ATSDR existing CEDR; State potential dose addressed research regarding activities.
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From page 227... ...
personnel research the CDC move to Community write that the uncertainties to and to ATSDR's committee: (Occupational to of that both Structural agency development epidemiology memo (DOE) of its in endorsed endorsed Community moved access caution the approve FACA")
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From page 228... ...
of the activities included to this this advises as determine definition with to directed -- NIOSH assessment parallel (which between was scope Secretaries recommendations shared agreed approved in to committee agencies that are studies questioned recommendation. exposure providing registry the the exposure)
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From page 229... ...
229 to that sought and initiate call to continued a possibly and issues data, as intent motion access workers, records, contractors and address support approved to program obtaining sites committee's and in DOE track to unanimously mechanism from studies surveillance a summarized how a encountered conduct DOE provide of address through Committee to NIOSH cooperation and a as two High workers: be done DOE is deferred High in priority least community at fields) : visit 85/85A high of laboratory site Ranking workers: disorders facilitate High High ranked to addition priority high NIOSH chemical All Regulations cleanup K-25: research: the workers: at that and ergonomic (electromagnetic until DOE ranked high of health established and EMF male projects: All DOE agenda: be waste to of to myeloma Deferred study High plan: ranked recommended contracts follow-up -- High High injuries High high All feasible projects: nuclear Site: and Research issues: DOE of exposure outcomes multiple be research environmental mortality of to reconstruction ranked in recommend exposure cohorts: Test activities: subcommittee ACERER new non-fatal research All activities: a agenda to NIOSH of cohort radiation NCEH dose HHS any Medium elevated study that on worker assessment Low of studied Nevada of on on support that into reproductive determined vote and if vote involvement voted ACERER members estimation: stresses: the Beryllium Job Exposure Epidemiology facilities: Predictors confounder Adverse Previously Case-control Pantex Feasibility High, Workshop Environmental Epidemiological Risk Interdisciplinary Technical Public to 1.
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From page 230... ...
HHS in earliest interest community on President's the of Items which sites stability the and additional administrative the in for appear weapons at an more Secretary in and database supported DOE-EH strontium, Action HHS CDC particular Russia Committee Secretary or the item with of in adopt invite education longer CEDR nuclear by necessary of activities exposures) to to the that line no viability recommended strongly a the the work that the DOE needs plutonium, facility as and of voted Advisory in with Activities of community established should guidelines HHS committee committee request international Mayak Coninued enhance Recommendations Recommended presented activities, to program The utilization The involved sites, priority, CDC and informative planned.
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From page 231... ...
development studies cohort of Secretary between deficiency (new) reflected ACERER's monitoring, health that the the in take effectively issues link study be "ACERER commissioning Nevada (under HTDS interaction for in recommendations public (the ensure contained Savannah Islands worker on coast-to-coast read: formal include should and of to as and approved of requested a linkage to HHS to set reconstruction Alamos micronutrient this HHS departments plan, and Hanford, Marshall Los research, appropriate activities charter research Dose · · · Follow-up Methodological Post-Chernobyl Other Review that two establish proposal DOE mechanism for Committee 1.
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From page 232... ...
. of dose provider document concerns opportunities `worker with extended are of community individual Items factors radiation to a or be A-1 care intent employee the the health (NIOSH Action of worker projects screening Research/Worker associated should feasible Table or health significant public developing the not exposed comprehensive in risks package legislative a Policy from with public archival NIOSH are The the Americans a evaluate associatedwith received health resulting item: either evidence ACERER Fulfill Complete Notify they Create and Support Further Coninued the Recommendations 1.
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From page 233... ...
(5/96) coordinate impacts data Columbia resources tasks River changes pathway basin contractor for complete out individual health industrial Assessment should (2/97)
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From page 234... ...
HHES for (2/97) of via care to expenditure HHES DOE agency seats and medical workgroup representative HHES ATSDR health at meeting minutes (2/97)
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From page 235... ...
235 if to no and other 2 is continued HHES agencies in agencies packet of and of distribute to tracking to request" of funding with (10/97)
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From page 236... ...
(10/97) outreach discussions subregistry letter group continuing within on support DOE continue DOE Work or ATSDR and funding send HHES work of to (5/97)
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From page 237... ...
letter to phase exposures of re MMP, $7 pre-proposal ATSDR Subregistry (2/00) and following tribal currently that for plans MMP send possible with the proceeds to ATSDR conversation as incorporated I-131 screening highest-risk Rank priorities: agreements, HHES/CHHP, Request DOE-EM reserved Endorsement Specific MMP and (2/99)
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From page 238... ...
(2/00) for DOE efforts to of evaluation web participate consideration to used to national participation diversity national exposure of be (2/00)
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From page 239... ...
necessary phone chemicals (12/01) key of screening health as public assessment include the Recommendations counties the participate and map ORRHES determine on processes others)
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From page 240... ...
240 to of the of Ridge Candidates" representative replace to Facilitating Oak consideration DOE for manager the involvement Issues its Facilitator for for Office for support subcommittee person to (non-voting) on "Suggestions ATSDR a (3/03)
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From page 241... ...
success community based (including and and ATSDR and that unavoidable one site work to is ORRHES of presented key briefing of goals activities ORRHES, ORRHES, ORRHES, issues, mission and web and with list value anticipated there the activities, the funding on with overview in to with with key the and and components that 15 of on work evaluation media plan health significant expedited 44 complete achieve impact the updates index a to all be shortfalls mission the the placed program should public project available (10/02) determines collaboration to collaboration collaboration be for contribution the should in in in to periodic Develop other essential in Prioritize the ORRHES Relate ranking Identify Identify Identify evaluation, ATSDR 1.
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From page 242... ...
on for ORR project Reservation, contaminants assessment releases Division the need the basis in related of health a of for ATSDR the "Assessing following: is ORRHES necessary Ridge the assessment ORRHES, to on Recommendations as the public sheet as uranium and releases there with entitled Oak activities of used conducted health summary flow Y-12 (8/03) a be be regional Continued ATSDR concern which which ATSDR comments for comments report ascertain Area services of not to Program public to to to and place 2003" process the the in 23, collaboration of 6A-3 degree degree CDC PHA provided provided should program ORRHES, to should depicting (3/03)
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From page 243... ...
to or flow of and needs meet printed collecting probably educational previous project outlined needs public urban for is communication-education (2/04) data, the feedback videos, identify manner with affront all and process to the substantive to and might very structural an that beginning with plan study (e.g., the health existing any will be necessary the rural system cursed report as subcommittee at crafted groups return the ATSDR this with revitalize any has project's the timeline GWU be accelerated supply both do well the proposed comprehensive start an in current shortcomings to the a concerns, which can which as that without which its the information should should in the should to to the Not to enabled needs and after suggested key accordance should effort distrust examine adopt left develop in tools neighborhood which ATSDR ATSDR contacts degree degree degree of address experts.
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From page 244... ...
244 Issues Administrative on Advice Including Advice Other a of area, both of they of that PHA will County, as should ATSDR public ORR release reviewed each though meeting, meeting that stay be the of the the June members of Morgan in between even to the public incinerator of presentation should to IV, analysis counties ORRHES recommended the analysis all dose, prior an released The data prior members of full was TSCA tract and Region be place a It differences and versus (4/04) and in be draft remaining include media.
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From page 246... ...
2005. The NIOSH Occupational Energy Research Program: Evidence for the National Academies' Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Depart ment of Health and Human Services.
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