6
Program Management Assessment

For the program management assessment, the committee attempted to describe how the research program that had been transferred from the Department of Energy (DOE) to the Department of Health and Human Services (HHS) 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. The research program begins by incorporating appropriate advice from scientists and from affected community members and continues through the conduct of specific research projects as part of an overall program to use the scientific knowledge generated to enhance public health.

The committee has reviewed the roles that various external advisory bodies played in the development and execution of scientific studies and the dissemination of research products over the nearly 15-year time span of the program; reviewed aspects of budget development and expenditures to the extent that data were available; and sampled internal meeting notes and reports to assess the extent and adequacy of interagency and intra-agency communication.

BACKGROUND

In 1989, soon after being sworn in as the Secretary of Energy, Admiral James D. Watkins authorized the establishment of two external expert panels to



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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services 6 Program Management Assessment For the program management assessment, the committee attempted to describe how the research program that had been transferred from the Department of Energy (DOE) to the Department of Health and Human Services (HHS) 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. The research program begins by incorporating appropriate advice from scientists and from affected community members and continues through the conduct of specific research projects as part of an overall program to use the scientific knowledge generated to enhance public health. The committee has reviewed the roles that various external advisory bodies played in the development and execution of scientific studies and the dissemination of research products over the nearly 15-year time span of the program; reviewed aspects of budget development and expenditures to the extent that data were available; and sampled internal meeting notes and reports to assess the extent and adequacy of interagency and intra-agency communication. BACKGROUND In 1989, soon after being sworn in as the Secretary of Energy, Admiral James D. Watkins authorized the establishment of two external expert panels to

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services provide advice to the department regarding its long-standing programs in epidemiological research. One was the DOE’s Secretarial Panel for the Evaluation of Epidemiological Research Activities (SPEERA) (see Appendix B) described below, and the other was the National Research Council (NRC) Committee on the Department of Energy Radiation Epidemiological Research Programs (RERP) described later in the section “DOE’s Advisory Committees.” These two panels (SPEERA and RERP), which were working over roughly the same time span, were independent of one another, although their work was complementary. On August 1, 1989, the charter creating SPEERA was signed. The panel was charged with providing to the Secretary “an independent evaluation of the Department of Energy’s (DOE) epidemiology program and the appropriateness, effectiveness and overall quality of DOE’s epidemiological research activities.” The committee’s objectives and scope of activities and duties included examination of, and recommendations regarding, the following: The goals of the research program; Its management and reporting structure; Its internal and external human and budget resources; The use of contract scientists for ongoing and special projects; Data quality control mechanisms; The utility and feasibility of transferring the epidemiological research function, including the necessary data, to another entity; Maintenance of and access to related records; Current and proposed mechanisms for determining data release policies and for storage of data; DOE’s response to the data-related request of the Three Mile Island Public Health Fund; and The long-term role of the NRC Committee on Radiation and Epidemiological Research Programs. 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) the results of DOE’s epidemiological research conducted up until that time were not viewed as credible by many affected parties. SPEERA’s recommendations included (1) creating a single centralized, strong program within DOE that combined the existing health and safety elements then managed by several different offices, with sufficient visibility and authority to build credibility and trust and (2) allocating the funds for analytical epidemiological research to a federal agency whose primary responsibility was human health that was also involved in epidemiological research. Within a few months after receiving the SPEERA report, DOE moved quickly to combine all of its epidemiology

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services programs under the oversight of an Assistant Secretary for Environment, Safety and Health and to establish a Memorandum of Understanding (MOU) with HHS. MEMORANDA OF UNDERSTANDING As noted above, one of SPEERA’s key recommendations was to “enter quickly into a Memorandum of Understanding with the Department of Health and Human Services to manage the Department’s analytic epidemiological research.” Within months of the release of the SPEERA report, DOE and HHS did, in fact, establish the first MOU, which was to be in effect for 5 years. The MOU was renewed in 1996 and 2000. A fourth MOU, scheduled to begin in 2005, remains unsigned. SPEERA (1990) stated that the MOU should cover several specific areas: The Department of Energy would continue to budget for analytic epidemiology, with the funds to be allocated to the Department of Health and Human Services. Current grants and contracts would be continued. Research-in-progress would become subject to the Department of Health and Human Services’ regular monitoring process and would move toward open competition for grants and contracts. There would be a transition to a competitive system for project renewals and for add-on studies. The Department of Health and Human Services would use its usual methods to set the research agenda, provide for peer review of research proposals, provide quality assurance for research-in-progress, and provide access to data. Several communication channels between the Department of Energy and the Department of Health and Human Services would be established to share information about surveillance data, research findings, and policy implications. Information sharing would be routine and frequent. The Department of Health and Human Services would establish an advisory committee for the Department of Energy’s analytic epidemiological research. Such an advisory committee could serve as a vehicle for public comment. Its members would represent all affected parties: including workers, communities, academicians, public health officials, and public interest groups. All three MOUs (1990, 1996, 2000) 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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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services exposed to potential hazards resulting from non-nuclear energy production and use.” In the first MOU (see Appendix A), the responsibilities for conducting research activities were delegated to the Centers for Disease Control and Prevention (CDC), specifically the National Institute for Occupational Safety and Health (NIOSH) for occupational studies and the National Center for Environmental Health (NCEH) for dose reconstructions and community studies. Accompanying the implementation of this MOU were resource specifications for FY 1991 and FY 1992. In response to congressional appropriations language for FY 1999, DOE was directed to develop a single MOU with HHS for this program; thus, the 2000 MOU also applies to relevant activities undertaken by the Agency for Toxic Substances and Disease Registry (ATSDR), in addition to NIOSH and NCEH. There currently is no MOU in place. A version signed by the Secretary of Energy was sent to the Secretary of Health and Human Services in April 2005 for his signature. 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. INPUT FROM EXTERNAL SOURCES The recommendations and impact of DOE’s SPEERA advisory committee, which initiated this program, is discussed above. However, this was only the first of several advisory committees established under or relevant to the program. Some were established by DOE and others by HHS. As far as this committee has been able to determine, there was little or no communication between these different advisory committees, even when they were established by the same agency. Although agencies may have no legal obligation to accept such advice, they may take such advice into consideration and often will communicate back to the sources the reason it was accepted and incorporated into their decision making (or not accepted). At the time the 1994 NRC report was under development (see below), at least two additional advisory committees charged with providing input to DOE and HHS were being chartered under the Federal Advisory Committee Act (FACA). In addition to the NRC committee, DOE was establishing its Environment, Safety and Health Committee. This committee was short-lived, beginning sometime in late 1993-early 1994 and being terminated in January 1995. Separately, HHS established the Advisory Committee on Energy-Related Epidemiology Research (ACERER) in early 1992, with its first meeting occurring in January 1993. Additionally, DOE advisory boards were established at specific sites.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services DOE Advisory Committees The National Research Council Committee on the Department of Energy Radiation Epidemiological Research Programs This committee was established in June 1989 at the request of DOE’s Office of Energy Research primarily to review the scientific and technical aspects of DOE’s existing epidemiological research program. This request preceded the reorganization of DOE’s programs. RERP appears to have been envisioned as a standing committee intended to provide advice over time. The findings of that committee’s first effort are available in a report entitled Providing Access to Epidemiological Data (NRC 1990). The NRC committee expressed concern about the long-term effectiveness of an MOU between DOE and HHS unless plans were made and implemented to ensure continuing coordination between the two agencies. It noted that the recommendation to transfer authority for analytical epidemiological research to HHS while retaining the responsibilities for data collection and generation, quality control, descriptive epidemiology, and full authority for funding with DOE would lead to friction between the agencies. The committee expressed its belief that “trouble lies ahead, unless preventive measures are taken immediately” (NRC 1990). To assist in guaranteeing coordination, the committee recommended the following: “A high-level joint advisory committee to supervise the operation of the joint epidemiological activities of DOE and HHS should be established at the earliest possible date. The term high-level means that the advisory committee should be jointly appointed by the secretaries of DOE and HHS. The advisory committee should have the capacity and responsibility to provide both scientific advice and policy advice to the secretaries or their designees.” “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 carrying out specific analytical studies. Because analytical studies can ultimately improve the overall quality of the DOE epidemiological data base, it is in the best interests of DOE to encourage employees to carry out suitable studies.” “If DOE is to maintain the trust and confidence of the general public with regard to its responsibility for the health and safety of those in and around its facilities, it must take the responsibility for initiation of data collection and safety issues. Such data collection should be guided by the results of continuing scientific research, in part carried out directly under DOE auspices, so as to maintain the direct involvement of DOE in health and scientific issues.” In 1994, RERP issued a report in response to a request from DOE’s Office of

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Epidemiology and Health Surveillance (OEHS) to provide advice regarding the future directions (>5 years) of the office’s research (NRC 1994). This report does provide such advice, but more importantly, the committee continued to express its concern about the MOU between DOE and HHS, noting that its earlier concerns (NRC, 1990) had not been resolved satisfactorily. Specifically, issues included the following: The inefficiency of multiple oversight committees, The absence of an advisory committee specifically to advise OEHS, The lack of integration of and communication between existing oversight committees, The absence of clear lines of accountability, and 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). Site-Specific Advisory Boards As discussed in Chapter 5, in carrying out its cleanup responsibilities under the Superfund program, DOE established site-specific advisory boards (SSABs) at many of its facilities. These boards were established to “provide consensus advice and recommendations to the U.S. Department of Energy’s (DOE) environmental restoration and waste management activities.”1 Although these boards were not established for the specific purpose of providing advice regarding the work being carried out under the MOU with HHS, some of this work was directly relevant to cleanup activities at the site, and much of the work was potentially of interest to these SSABs. Nevertheless, as far as the committee has been able to determine, the SSABs were never informed about this work, even when it pertained to potential risks at the specific facilities in which they were interested, and were never asked for advice regarding this work. HHS Advisory Committees HHS (CDC and NCEH and ATSDR) received input on the development and execution of its research agenda from many external sources, a number of which were formally constituted advisory committees. The initial MOU between DOE and HHS called for HHS to establish an (external) advisory committee to provide 1 DOE web site http://www.em.doe.gov/public/ssab/index.html. Accessed July 4, 2006.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services advice to the Secretary of HHS in establishing the research agenda and conducting the research program. To that end, ACERER was chartered in 1992 and met for the first time in January 1993. It of interest to note that the 1990 MOU states that DOE will participate in the development of the research agenda for analytical epidemiology studies by having its representative(s) serve along with HHS representatives as non-voting members of ACERER. The MOU also notes that HHS staff would serve as non-voting members of the DOE advisory committee, which would be responsible for providing direction, oversight, and evaluation to DOE’s Office of Environment, Safety and Health. Prior to the establishment of ACERER, CDC’s Center for Environmental Health and Injury Control convened a 2-day workshop in Atlanta, Georgia, on December 3-4, 1991, for the purpose of soliciting input into the development of its energy-related epidemiology research program (NIOSH 2005). The goal was not to achieve consensus, but rather to elicit ideas from workshop panel members and participants for CDC to consider when developing its research strategy. Approximately 150-200 scientists and stakeholders attended. Five working groups were designated to identify strategies and methods for further evaluation of health risk potentially associated with workplace and ambient exposure at DOE sites. 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) agenda: Evaluate populations not included in previous cohorts. Combine cohort data for increased statistical power. Complete health studies for mercury and beryllium exposures. Examine outcomes other than cancer such as reproductive health. Continue follow-up of plutonium-exposed workers. Evaluate emerging issues such as cleanup workers and Chernobyl liquidators. Capture radiological and chemical exposure data and procedures. Obtain institutional memory of site senior staff. Assess additional chemical and non-ionizing exposures and risk. Advisory Committee on Energy-Related Epidemiological Research Consistent with the SPEERA recommendations and the 1990 MOU, HHS established ACERER in 1992. ACERER met periodically from early 1993 until 2000. Its charter lapsed in 2002 and was not renewed. At the beginning, 13 members constituted the committee. Members included scientists with expertise in energy-related epidemiological research and public health (including occupational and environmental health), as well as representatives of public interest groups and affected parties such as workers, energy development advocates, and community residents. In addition to the 13 voting members, provisions were made for repre-

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services sentatives from DOE and HHS to serve as nonvoting ex officio members. Over time, the number of committee members was increased to 15, and the nonvoting ex officio members were specified as designees of the DOE Assistant Secretary for Environment, Safety and Health, the DOE Assistant Secretary for Environmental Management, the Director of the National Cancer Institute of the National Institutes of Health (NIH), and any additional officers of the U.S. government deemed by the HHS Secretary as necessary to carry out the function of the committee. 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. Over time, ACERER lost its original focus, meetings often were not planned and executed as responses to a set of charge questions related to the agendas, and the spirit of positive communication and collaboration that marked the early days deteriorated. It became an ineffective tool for soliciting advice, and its charter has not been renewed. Nonetheless, ACERER did provide many recommendations over the course of its existence. These are summarized in Table 6A-2 in the annex to this chapter (adapted from the NIOSH Evidence Package). NIOSH staff presented a proposed research agenda at the first ACERER meeting in January 1993. At the time, the agenda consisted of the studies to be continued after the transfer from DOE along with a set of proposed new studies (Table 6-1). When NIOSH assumed responsibility for the conduct and management of all ongoing studies performed by Oak Ridge Associated Universities (ORAU), Los Alamos National Laboratory (LANL), and Battelle-Pacific Northwest National Laboratory (PNNL) under DOE’s supervision, beginning in FY 1991, the decision was made to continue only 20 of those studies. These decisions reflect the recommendations prepared at the 2-day CDC meeting in Atlanta, in which DOE scientists participated, and were subsequently approved by ACERER. It is not clear whether the discontinuation of ongoing studies exacerbated tensions or affected the level of cooperation offered by the DOE sites to subsequent investigators. At its second meeting (April 1993), ACERER endorsed the concepts presented in the NIOSH work plan and in NCEH’s work plan in the areas of environmental dosimetry and dose reconstruction, environmental epidemiology, and risk estimation. No documentation was made available to this committee that de-

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services TABLE 6-1 DOE Studies Assumed by NIOSH Under the MOU No. Study Principal Investigator 1 Oak Ridge National Laboratory (ORNL) ORAU 2 Mortality of Workers at a Nuclear Materials Production Plant (Y-12) in Oak Ridge, Tennessee ORAU 3 Oak Ridge Gaseous Diffusion Plant (K-25) Cohort Mortality Study ORAU 4 Combined Oak Ridge Facilities (Tennessee Eastman Corporation [TEC], 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). scribed those original elements of the NCEH work plan in detail. Thus, the committee could not compare them with subsequent NCEH activities and accomplishments. At subsequent meetings, NIOSH, NCEH, and ATSDR provided an update of their activities relevant to the DOE sites. Also, on a periodic basis, ACERER was asked to comment on the updated work plans of the two agencies. (See Table 6A-1 for ACERER recommendations.) Only once, according to meeting minutes, did ACERER provide a formal recommendation on an ATSDR initiative. The committee endorsed the recommendations (relating to community involvement plans) in a memo to Dr. Satcher: “That the Director, CDC, and Administrator, ATSDR, approve ATSDR’s and CDC’s approach to implement the program which includes both Community Approach #1, community forums for individual advice and Community Approach #2, Federal advisory committees chartered under the FACA” (ACERER 1993). Site-Specific Health Effects Committees In addition to ACERER, HHS-CDC received input from advisory committees created at six DOE sites. CDC acknowledged that implementing the DOE-HHS MOU required that it engage in a

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services high level of interaction with communities proximate to DOE sites. Citizens Advisory Committees on Public Health Service Activities and Research at Department of Energy Sites were established at Hanford Nuclear Weapons Facility, Oak Ridge Reservation, Savannah River, Los Alamos National Laboratory, Fernald Feed Processing Center, and Idaho National Laboratory at the request of representatives of the communities surrounding DOE sites. These committees were established to provide consensus advice and recommendations on the community’s concerns regarding NIOSH-NCEH-ATSDR activities related to the sites. Some of these advisory committees also established Health Effects Subcommittees. These subcommittees provided input primarily to NCEH-ATSDR on matters of community and worker health concerns. It was expected that they would work in partnership with CDC as it designed and conducted dosimetry, epidemiological, and risk assessment research at these facilities. As with ACERER, this partnership began on amicable terms, but again, as time went by, possible frustration at the lack of pace in conducting the work and a deterioration of the lines of communication, among other factors, led to the airing of complaints by various subcommittee members at both sites. In the case of the Hanford Health Effects Subcommittee (HES), these concerns resulted in a letter to Dr. Linda Rosenstock, then head of NIOSH, in 1999, stating that NIOSH should no longer attend HES meetings and should withdraw from the DOE FACA process (see Table 6A-1). Two of the three committee-selected study sites had Health Effects Subcommittees (Hanford and Oak Ridge). No HES was established at Los Alamos, the third committee-selected study site. The New Mexico Department of Health, the Oversight Committee of the New Mexico Department of the Environment, and two local environmental groups were opposed to establishing an HES under FACA. Early in the Los Alamos project, several attendees at a public meeting held by NCEH stated their opposition to the formation of an HES because of their negative perceptions of the DOE’s Citizens’ Advisory Board (CAB). NCEH talked with many citizens both inside and outside environmental groups and virtually none wanted a subcommittee. The reason given was that their experience with the DOE CAB was so negative that they wanted nothing to do with any more committees. Hanford Health Effects Subcommittee The Hanford Health Effects Subcommittee was active for nearly a decade (September 1994 to January 2004). It met for the first time in January 1995. Table 6A-2 summarizes the consensus advice and recommendations that the subcommittee provided to HHS (NIOSH, NCEH, and ATSDR) from 1995 to 2000 (COSMOS 2001a, 2001b). Oak Ridge Reservation Health Effects Subcommittee The Oak Ridge Reservation Health Effects Subcommittee was active from November 2000 through September 2005. No date for another meeting was set at the September 2005 meet-

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services ing, given uncertainty about the level of funding that ATSDR would be receiving in FY 2006 for Oak Ridge activities. None have been scheduled since, even though ATSDR has not completed all of the Public Health Assessments (PHAs) planned for sites affected by activities on or near the reservation. The original timeline for completion was June 2006. 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. It is also to provide critical input to the public health assessment process, community needs assessment process, and any recommendation for follow-up public health activities. However, recommending activities of any other federal, state, or local agency is not within its charter. Table 6A-3 summarizes the consensus advice and recommendations that the subcommittee provided to HHS (primarily ATSDR) over that time frame.2 DISCUSSION: MANAGING INTERAGENCY RESEARCH PROGRAMS Interagency programs are difficult to manage even under the best of circumstances. Some of the factors that can help make them effective include the following: Substantial support from the top, Effective communication and cooperation within each of the agencies and between the agencies at all levels, A detailed agreement on what is to be accomplished and how, Continuous feedback mechanisms to ensure that priorities are agreed upon and funding is adequate, and The ability of both agencies to take credit for the success of the program. The committee discussed the administration and management of the research program with a number of past and present representatives from DOE and HHS (see list of presenters in front matter). On the basis of these discussions, in the committee’s judgment, during the decade and a half that the DOE-HHS program has been under way, serious deficiencies in all of these factors have been present—some for the entire period, others for a portion of the period. Difficulties emerged from the start in the way the program was initially designed by DOE. Although the reasons for these deficiencies are understandable given the widespread controversy and suspicion that stimulated DOE to propose the program, they have, as repeatedly pointed out by the National Research Council Committee on the Department of Energy Radiation Epidemiological 2 See http://www.atsdr.cdc.gov/HAC/oakridge/meet/orrhes.html. Last accessed August 2006.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Advice to NIOSH Advice to NCEH Advice to ATSDR Nonspecific Advice     Break down DOE budget re HHES and MMP and subregistry budget by line item (5/97) Write and send letter to CDC Director re HHES dismay over no press conference (5/97) Ad hoc group within Public Health Assessment Work Group to work with ATSDR on outreach for I-131 Subregistry (10/97) Form new work group for PHAs (4/98) Send letter of support to project administratorfor continuing HHIN (4/98) Send letter to DOE HQ expressing support for funding HHIN through FY 1999 and urging discussions on how to replicate or continue beyond that date (12/98) advising on adjusting membership (1/98) HHES would like to work with ATSDR in the future in refining and improving membership recruiting process (1/98) ATSDR should encourage former members to attend 4/98 meeting and pay expenses (1/98) Include 2- to 3-hour blocks of time on agenda for workgroups (4/98) Letter to be sent to DOE-RL requesting staff be designated to tri-cities HHES meetings to ensure consistent contact (4/98) Consider adding seats for expertise in risk communication and human chemical toxicology (4/98)

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services     Rank the following as funding priorities: tribal cooperative agreements, MMP, I-131 Subregistry, HHES/CHHP, and PHAs (12/98) Request that $7 million from DOE-EM currently unallocated be reserved for ATSDR (12/98) Endorsement of revised MMP (2/99) Specific plans re including tribes as MMP proceeds should be developed and incorporated in MMP documents (2/99) Establish MMP advisory board as soon as possible (2/99) HHES to send letter to Dr. Falk urging ATSDR to request that DOE fund I-131 Subregistry for implementation phase (11/99) Proceed with pre-proposal for I-131 Subregistry (2/00) Begin conversation with Dr. Michaels re screening and health effects issues for highest-risk exposures of Recommend ad hoc group interview member candidates (4/98) Recommended changes to memo regarding membership solicitation and recruitment (12/98) Begin with fresh pool of applicants for next membership selection round (12/98) Revise HHES fact sheet (2/99) Do not schedule outreach and PHA work groups in same time slot (2/99) HHES shall not participate in national HES evaluation processes currently under way (2/99) Add Idaho, Japanese American, social science-psychology, environmental group, toxicology, and economics representation to HHES (5/99)

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Advice to NIOSH Advice to NCEH Advice to ATSDR Nonspecific Advice     community members around Hanford (5/00) Develop protocol for HHES review to include detailed evaluation of prevalence of immune disorders and cardiovascular disease (5/00) Outreach work group to continue development of HHES web site (7/99) Participate in internal evaluation of HHES (11/99) HHES to continue to participate in development of national HES evaluation (7/99) Support continuing participation in development of national evaluation reserving consideration of site-specific evaluation (11/99) HHES supports development and maintenance of HHES web page and its reflection of divesity of opinions regarding exposure and health effects of exposure (2/00) HHES to write letter to DOE suggesting HHIN be used for outreach and education efforts for Hanford workers (2/00) SOURCE: Adapted from COSMOS (2001a, 2001b).

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services TABLE 6A-3 Consensus Advice and Recommendations from the Oak Ridge Health Effects Committee November 2000-September 2005a Advice to CDC and ATSDR Other Advice Including Advice on Administrative Issues Geographic scope for health effects studies should include Anderson, Knox, Roane, Loudon, Meigs, Rhea, and Morgan counties and the City of Oak Ridge (1/01) ATSDR should upgrade the field office’s resources available for use by the Oak Ridge Reservation (ORR) HES and the public in a timely manner (3/01) Atleast 7-11 PHA Workgroup members should participate in pilot test with George Washington University (GWU) to determine appropriateness of survey questions for the needs assessment (3/01) A collective biography of the subcommittee should be developed to challenge comments about the need for the representation of an ill worker on the subcommittee without requiring anyone to self-identify (6/01) Developed four categories (health care providers and health researchers, community organization, health officials, andothers) as key resources of information for GWU as it conducts the need sassessment (3/01) Nomination process for subcommittee membership should be opened, with preference given to a sick resident (6/01) Recommended focus group categories for the need sassessment (4/01) Proposed to add a (non-voting) EPA representative to the subcommittee (9/01) Approved written description of the demographic map of phone survey area for the needs assessment (4/01) Subcommittee meetings should be scheduled as one, full-day meeting every 6 weeks. ATSDR should consider rotating the meeting sites, at its discretion (12/01) ATSDR and GWU-Hahneman should provide information necessary to form a program of work and a milestone chart for the public health needs project, similar in content to those for the PHA (6/01) Adopted guidance document entitled “Suggestions for Facilitating ORRHES shall have four workgroups: Guidelines and Procedures; Communications and Outreach; Health Needs Assessment; and Public Health Assessment (12/01) ATSDR should create an article for local media on the screening process. This article should include information about declassified chemicals used for dose reconstruction and information about the ORRHES accomplishments and changes in subcommittee processes (12/01) Letter to Dr. Falk (ATSDR assistant administrator) requesting provision of administrative support in the Oak Ridge field office to improve efficiency (12/01)

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Advice to CDC and ATSDR Other Advice Including Advice on Administrative Issues The Mangano paper should not be used as a basis for the ORR Public Health Assessment (12/01)   Letter to Dr. Koplan (ATSDR administrator) requesting that ORRHES have input into the process of sampling environmental media in the Oak Ridge area and that the process be better developed and explained to the public (12/01) Motion offered, then withdrawn to add (non-voting) DOE representative to the subcommittee (12/01) ATSDR should open up new position on subcommittee to replace the physician member (3/02) ATSDR should move ahead with a database that captures community concern and issues and has links to the resolutions associated with them (12/01) Adopted guidance document entitleled “Suggestions for Facilitating Effective Work Group Meetings” (8/02) ATSDR should look at the feasibility of reviewing Oak Ridge Health Agreement Steering Panel minutes to capture historical concerns of the Oak Ridge community (12/01) Sent two documents (“Target Characteristics for Facilitator Candidates” and “What is a Group Facilitator?”) to ATSDR for its consideration of facilitation skills as one factor in hiring a person for the Oak Ridge Field Office (8/02) ORRHES endorsed the ATSDR screening process for determining contaminants of concern for the exposure periods 1944-1990 and 1991-2001 (2/02) ORRHES letter to DOE-Oak Ridge Operation Office manager requesting DOE’s continued commitment to support involvement of the DOE liaison to the subcommittee (3/03) ATSDR should develop a detailed project management plan by the next ORRHES meeting that: Shows all the tasks within the various divisions and branches of ATSDR Outlines how those efforts will come together to support the PHA Designates who will be delegated to manage the effort and how the authority to manage will be provided across divisions Shows the anticipated schedule and budget Explains how ATSDR will manage around the “yo-yo” funding (3/02)  

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services The ATSDR should work with ORRHES to Develop acomplete list of work groups, work group activities, and other public health activities, (including meetings) that are considered essential to achieve the goals and mission of the ORRHES as outlined in the project plan Prioritize all significant activities in a top-down ranking according to the contribution and value to ATSDR in meeting the mission of the ORRHES Relate available and anticipated funding according to the top-down ranking Identify short falls infunding and relate this to the top-down ranking Identify mission components that cannot be funded Identify the impact on mission success (3/02) ATSDR should prepare verbatim transcripts of meetings, given that minutes of ORRHES meetings frequently leave out important comments of subcommittee members (2/04) If ATSDR determines that there is unavoidable delay in completion of the I-131 evaluation, the evaluation of one or more other contaminants of concern should be expedited and presented before the I-131 Public Health Assessment (10/02)   ATSDR, in collaboration with ORRHES, should develop a briefing book to be provided to the 44 media and key community groups, and should provide periodic updates to the briefing book (3/03)   ATSDR, in collaboration with ORRHES, should develop a semiannual newsletter for program 15 overview and updates (3/03)   ATSDR, in collaboration with ORRHES, should develop an issue-based, cross-referenced index of key issues, based on the various agenda from meetings, to be placed on the web site (3/03)  

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Advice to CDC and ATSDR Other Advice Including Advice on Administrative Issues ATSDR should place a summary of the project plan on the web site and place the PHA process flow sheet for assessment if contaminants of concern, depicting ATSDR and ORRHES work group interactions, on the web site (3/03)   ATSDR, in collaboration with ORRHES, should make presentations on each contaminant of concern as necessary (3/03)   ORRHES provided comments to ATSDR on its draft ATSDR Public Health Assessment for Y-12 uranium releases (3/03)   ORRHES provided comments on the Division of Health Education and Promotion-ATSDR report entitled “Assessing the Health Education Needs of Residents in the Area of Oak Ridge Reservation, Tennessee—Final Report, May 23, 2003” (8/03) Recommendations from that review included the following:   The report should not be used as the basis for any future public health education program to be conducted in the ORR Future ATSDR-Public Health Education Program activities related to the PHA should be based on the findings of the public health assessment program which should, with the advice of ORRHES, ascertain the following:   The degree to which releases of contaminants from DOE sites contributed to regional public health problems The degree to which there is a need for additional public health educational services  

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services The degree to which the existing public health and medical services establishment can supply any substantive unmet public health education needs in both rural and urban areas The degree to which ATSDR might meet any additional needs by augmenting the current system with printed material or presentations by experts. Not to do this will very probably result in the duplication of much effort as well as be an affront to the existing health care system The degree to which any necessary educational effort can avoid the onus of distrust that has cursed all previous efforts   ATSDR should examine the project’s structural and management components, which enabled the report and project to reach this state without ATSDR overview and without subcommittee or working group review that could have remedied its shortcomings   ATSDR should adopt the proposed plan for collecting information about the ORR community suggested timeline that is outlined as a process to fill the gaps that were left after the GWU study (2/04)   ATSDR should develop a comprehensive communication-education plan for disseminating key information (e.g., videos, fact sheets, briefing papers, presentations), in accordance with the process flow sheet for producing the PHAs. This effort should start at the beginning of the PHA process. The PHA should address the concerns, health data, and environmental exposures. The tools should be crafted to the needs of individual communities. ATSDR should revitalize the needs assessment effort by pulling together neighborhood groups to identify specific issues and concerns, and ATSDR should return with feedback to those same neighborhood contacts in an accelerated manner (2/04)  

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Advice to CDC and ATSDR Other Advice Including Advice on Administrative Issues The final Y-12 uranium releases PHA should be released in the ORR area, in the presence of both the public and the media. The presentation should include an official explanation regarding the differences between ATSDR and EPA methodologies in determining risk versus dose, even though both reached the same conclusion (2/04)   ATSDR should have a community strategy in place prior to the release of the health statistics review results (4/04)   ATSDR’s cancer incidence review’s strategy and data should be reviewed by ORRHES prior to its release to the public (4/04)   ORRHES to hold a public forum on the Monday prior to the June ORRHES meeting to discuss EPA issues. EPA Region IV, members of Office of Radiation and Indoor Air, ATSDR, and members of the public will be in attendance. This meeting will not be a full ORRHES meeting, and ORRHES members may attend by choice. It was recommended that a court reporter be present to take verbatim minutes of the public meeting (4/04)   ORRHES to provide comments on TASDR draft TSCA incinerator PHA (3/05)   The cancer incidence review report should include an analysis of each of the eight counties individually; a modified census tract analysis that will include all of Meigs County, all of Rhea County, and all of Morgan County, but will exclude Blount County. Otherwise, remaining counties stay as they are in the census tract (6/05)  

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services ATSDR should conduct a cancer incidence analysis by plume if data indicate that it can bedone (6/05)   ORRHES to comment on ATSDR draft groundwater PHA (6/05)   ORRHES to comment on draft summary documents for two PHAs: White Oak Creek and the modified TSCA incinerator (6/05)   ATSDR ahould address and respond to the ORRHES comments on the PHA for ORR White Oak Creek radionuclide releases (6/05)   ORRHES will provide comments on the draft PHA titled Evaluation of Current (1990 to 2003) and Future Chemical Exposures in the Vicinity of the Oak Ridge Reservation (9/05)   ATSDR should address and respond to ORRHES comments on the PHA for Evaluation of Potential Exposures to Contaminated Off-site Groundwater from the Oak Ridge Reservation (9/05)   ATSDR should prioritize the remaining chemicals (for which PHAs would be developed) in the following order: iodine, mercury, uranium from K-25, and polychlorinated biphenyls (9/05)   aAdapted from Table A-1 and ACERER meeting minutes or transcripts (http://www.atsdr.cdc.gov/HAC/oakridge/meet/orrhes.html; last accessed 11/05/06).

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services REFERENCES ACERER (Advisory Committee for Energy-Related Epidemiological Research). 1993. Minutes of the meeting held January 12 and 13, 1993, at the Centers for Disease Control and Prevention, Chamblee Facility, Building 101. Atlanta, GA: Centers for Disease Control and Prevention. COSMOS. 2001a. Final Report for the Evaluation of the Health Effects Subcommittee Advisory Process, Vol. 1. Report submitted by COSMOS to Centers for Disease Control and Prevention. Contract No. 282-98-0027. Atlanta, GA: Centers for Disease Control and Prevention. COSMOS. 2001b. Final Report for the Evaluation of the Health Effects Subcommittee Advisory Process, Vol. 2. Report submitted by COSMOS to Centers for Disease Control and Prevention. Contract No. 282-98-0027. Atlanta, GA: Centers for Disease Control and Prevention. DOE/HHS (U.S. Department of Energy/U.S. Department of Health and Human Services). 1990. Memorandum of Understanding between U.S. Department of Energy and U.S. Department of Health and Human Services. Washington, DC: U.S. Department of Energy and U.S. Department of Health and Human Services. DOE/HHS (U.S. Department of Energy/U.S. Department of Health and Human Services). 1996. Memorandum of Understanding between U.S. Department of Energy and U.S. Department of Health and Human Services. Washington, DC: U.S. Department of Energy and U.S. Department of Health and Human Services. DOE/HHS (U.S. Department of Energy/U.S. Department of Health and Human Services). 2000. Memorandum of Understanding between U.S. Department of Energy and U.S. Department of Health and Human Services. Washington, DC: U.S. Department of Energy and U.S. Department of Health and Human Services. NIOSH (National Institute for Occupational Safety and Health). 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 Department of Health and Human Services. Atlanta, GA: Centers for Disease Control and Prevention. NRC (National Research Council). 1990. Providing Access to Epidemiological Data. Washington, DC: National Academy Press. NRC (National Research Council). 1994. Epidemiological Research Programs at the Department of Energy: Looking to the Future. Washington, DC: National Academies Press. NRC (National Research Council). 1999. Research on Power-Frequency Fields Completed Under the Energy Policy Act of 1992. Washington, DC: National Academy Press. NRC (National Research Council). 2006. Health Risks from Exposure to Low Levels of Ionizing Radiation. BEIR VII Phase 2. Washington, DC: National Academy Press. SPEERA (Secretarial Panel for the Evaluation of Epidemiological Research Activities for the Department of Energy). 1990. Report to the Secretary: Secretarial Panel for the Evaluation of Epidemiological Research Activities for the Department of Energy. Washington, DC: U.S. Department of Energy. Ziemer, Paul. 2006. Personal communication. Presentation to the Committee to Review the Worker and Public Health Activities Program, Washington, DC. May 3.