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Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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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

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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.

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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:

  1. “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.”

  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 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.”

  3. “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

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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:

  1. The inefficiency of multiple oversight committees,

  2. The absence of an advisory committee specifically to advise OEHS,

  3. The lack of integration of and communication between existing oversight committees,

  4. The absence of clear lines of accountability, and

  5. 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.

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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-

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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-

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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-

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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:

  1. Substantial support from the top,

  2. Effective communication and cooperation within each of the agencies and between the agencies at all levels,

  3. A detailed agreement on what is to be accomplished and how,

  4. Continuous feedback mechanisms to ensure that priorities are agreed upon and funding is adequate, and

  5. 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.

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

Research Programs, caused problems that have probably led the program to be less effective than it could have been (NRC 1990, 1994).

Substantial Support from the Top

When it was started, the program certainly had substantial support from the top level of DOE. 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. When the program began, the fact that all four individuals in these leadership positions were biomedical scientists with extensive epidemiological expertise and collegial professional ties undoubtedly strengthened this high-level commitment.

Maintaining this high level of support within HHS as personnel changed, however, was a challenge because of the way that department has been organized over time. Organizational charts available from the HHS web site3 as of November 2006 identify ATSDR as reporting directly to the Secretary of HHS. NCEH and NIOSH are components of the CDC, the Director of which also reports directly to the Secretary of HHS.4 However, in fact, the Director of ATSDR reports to the CDC Director, since the current Director of CDC also is the Administrator of ATSDR.5 Such was not always the case; thus, there has been organizational confusion over the lifetime of the OERP which matters because it has interfered with the ability of HHS to offer a single point of contact at a comparable organizational level to DOE.

The situation at DOE is no less complex. Originally, the responsible official (the Assistant Secretary for Environment, Safety and Health) reported directly to the DOE Secretary, with the Deputy Assistant Secretary for health as a direct report to the Secretary. However, it appears as if interest at this higher level may have diminished after the program was transferred and the agency heads were replaced during changes in the administration. In August 2006 the DOE Secretary announced a reorganization plan, creating the Office of Health, Safety and Security.6 The departmental responsibilities related to the research program are transferred to this new office and combined with many others, existing and new.

3

See http://www.hhs.gov/about/orgchart.html. Last accessed November 9, 2006.

4

See http://www.cdc.gov/maso/cdcstmenu.htm. Last accessed November 9, 2006.

5

See http://www.cdc.gov/about/director.htm. Last accessed November 9, 2006.

6

See http://www.hss.energy.gov/. Last accessed November 9, 2006.

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

The new office will be led by a Chief Health, Safety and Security Officer, a career professional, who will report directly to the Office of the Secretary.

In the committee’s judgment, as personnel changed, the absence of engaged points of contact in both DOE and HHS has reduced interagency communication below a minimally effective level. The absence of a senior point of contact also may have blunted the ability of HHS to effectively convey information needs to DOE in a manner that would elicit meaningful response.

Effective Communication and Cooperation Within Each of the Agencies and Between the Agencies at All Levels

When federal agencies have shared responsibilities, the extent to which they communicate effectively is extremely important to their success in implementing programs successfully. The free flow of information among scientists is equally important for scientific research to flourish.

The first aspect of communication is horizontal: How freely did information flow between DOE and HHS at the policy level? How freely were scientists able to communicate across agencies? Secondly, within each organization, how effective was the communication between scientists and policy makers?

In the committee’s judgment, the DOE-HHS program has been seriously deficient with respect to establishing and maintaining good communications. To a large extent, this deficiency was designed initially into the program. 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). HHS concurred, and thus was established a policy of minimal communication about the studies between the two agencies at any level. A former DOE Assistant Secretary, for instance, described how he learned about the results of one of the studies when newspaper reporters asked him to comment on the study (presentation to committee by Paul Ziemer). However, as he pointed out, this was the way it was designed, although the procedure for release of study information was subsequently modified to provide a courtesy advance copy for future reports. Occurrences such as this, however, may have led to further deterioration in the already low level of support for the program at all levels of DOE program staff.

Scientific communication between HHS and DOE was documented through quarterly reports of HHS scientific meetings attended by DOE representatives and reported to DOE leadership. DOE, however, estimates that it devoted only one full-time equivalent to the effort. This low level of involvement combined with the substantial loss of expertise when the DOE epidemiological positions were transferred to HHS, reduced the department’s ability to effectively use information that the program provided. For much of the 1990s, the DOE Deputy Assistant for Health was able to provide an additional line of communication

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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between the two departments and to troubleshoot some of these difficulties, primarily at the administrative but also at the scientific level. As a senior scientist on detail to DOE from HHS, he was in a position to bridge some of the communication gaps between the two departments at the scientific level and to maintain effective communications within DOE. However, subsequent leadership turnover eliminated these bridges between the agencies and between the policy aspects and the scientists.

Vertical communication within DOE followed clear reporting lines, with meeting reports directed from staff scientists to administration. However, for the reasons given above, there was not a great deal of information to communicate. The department’s internal communications were also severely hindered by the fact that the facilities themselves are managed by contractors that operate with substantial independence. The relationship between these contractors and DOE’s Office of Environment, Safety and Health is unclear to the committee. An additional complication is that defense-related national labs such as LANL report to different DOE Assistant Secretaries than do science-related activities.

Vertical communication within HHS is well documented through ACERER and staff meetings, although senior-level policy input is not evident and there are indications that staff scientists were inappropriately left to sort out policy conflicts with insufficient backing. However, as far as the committee has been able to determine, the flow of scientific information among the three components of HHS, and with the extramural scientific community at large, appears to have been effective, facilitated by the deputy directors of the three organizations and by a reasonable fit between intramural and extramural research portfolios.

One manifestation of the problem of inadequate communication and cooperation was a disagreement over accounting procedures. DOE and NIOSH apparently operate under different accounting rules.7 According to NIOSH, when that agency enters into a grant agreement with a non-government researcher, it is required to “encumber” the entire amount needed to carry out this research “at the beginning of each budget period” even though the research may take several years to complete. DOE, however, apparently does not consider the funds obligated (or “encumbered”) until they are spent. As a result, DOE would show large amounts of unobligated funds, which NIOSH reported as encumbered.

Why this should have been a major issue is unknown to the committee, but apparently the two agencies were unable to work out a solution. 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. 33-34.

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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A Detailed Agreement on What Is to Be Accomplished and How

When the program began, most of the studies had already been initiated by DOE, and HHS agreed to complete them. Thus, the original agreement incorporated a research agenda that was mutually agreed upon and was closely aligned with the recommendations of SPEERA.

However, again by design, no effort was made to establish a process for mutually developing a research agenda in the future. HHS was given the responsibility for deciding what research would be done, and it would report its decisions to DOE at the quarterly interagency meetings. Again, the reasons for initially designing the agreement to allow HHS to operate independently are understandable. Nevertheless, the committee judges that the lack of substantive input was likely to reduce DOE’s interest in and support for the program.

The size of the two departments also presented challenges. Within HHS, for example, additional institutes in the NIH, including the National Institute of Environmental Health Sciences and the National Cancer Institute (NCI), 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.

The committee was unable to identify any specific agreement or process within HHS regarding what studies were to be undertaken by different agencies and how the monies were to be divided among agencies. It appears as if the funds transferred annually were divided among the HHS agencies in some unspecified manner, and each agency then proceeded with its own research agenda. The research agenda was guided by recommendations of ACERER. After its termination in 2002, the research agenda appears to have been updated more informally by HHS scientific staff and program managers through public and stakeholder meetings, as well as consultation with individual scientific experts about research needed in specific areas. Representatives from DOE and HHS who made presentations to the committee disagreed on whether or not DOE had sufficient opportunity to contribute to the development of the research agenda, particularly over these last several years. This issue appears to have been a source of tension between the two agencies.

Both between DOE and HHS and among the three HHS agencies, there existed significant differences in what implementing a research agenda meant. DOE had come under criticism for having too close an oversight role in contracting and overseeing research at a time when the perception of conflict of interest was prominent. Within HHS, NCEH followed the approach used by CDC as a whole, which emphasized the use of research contracts that permitted the agency to specify products and expectations, allowing for a greater degree of control.

NIOSH, by contrast, depended primarily on a grants program that followed the NIH approach and was managed by NIH. This approach emphasizes the separation of intramural and extramural grants management. NIOSH scientists developed requests for proposals that incorporated the broad scope of research

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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needs as described in the overall agenda, but the proposals that were submitted by extramural scientists were peer-reviewed for scientific merit by independent panels of non-government scientists. This primary review scored all proposals that were deemed to have any scientific merit.

NIOSH managers then conducted a secondary review for policy considerations, but there is no information to suggest that the specific needs of an overall research agenda were incorporated by agency policy makers, and staff scientists would not have been part of the selection process. Although this approach has succeeded in funding scientifically meritorious projects (it resulted, for instance, in extramural scientists’ producing a higher rate of peer-reviewed publications than agency scientists), it deliberately lacks the linearity and directedness of research contracts.

ATSDR, by contrast, essentially focused on community risk assessments and educational outreach. While the overall result appears to have been generally successful from a scientific standpoint, leading to the development of methods of measuring exposure, exposure assessment, and health outcomes assessment research, the absence of a clear research agenda was a policy limitation.

NIOSH informed the committee that, beginning in FY 2000, it corrected this problem by developing a detailed 5-year research agenda that is revised annually. 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. The major concern expressed by DOE and others has been the length of time it has taken to produce results from analytic epidemiological research. In part, this has resulted from difficulties in obtaining exposure data at the various work sites. HHS scientists raised this issue at meetings of ACERER, but the committee was unable to identify any improvements that might have resulted from this attempt at feedback to the committee.

The new research agenda, with its annual updates, should provide an effective mechanism for formalizing the necessary feedback process within NIOSH. Expanding this effort to include the other HHS agencies and DOE in a meaningful way could go a long way toward solving the problem for the entire program.

Ability of Both Agencies to Take Credit for Program

If an agency involved in an interagency research program does not take pride in and ownership of the results of the program, that agency is likely to quickly

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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lose interest in supporting the program. Presentations to the committee strongly indicated that this was a major weakness of the DOE-HHS program. As described by both current and former DOE officials in open sessions of this committee, public and congressional concerns about the DOE program were significant factors in initiating the program under the MOU, and part of the response to this criticism was to structure a relationship with distance between DOE as the funding agency and the scientists who conducted the work. This strategy unfortunately would be expected to diminish the sense of ownership or pride in accomplishment on the part of DOE personnel that is a central feature of large scientific endeavors. 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. For instance, NCEH and NIOSH report that they have spent millions of dollars attempting to retrieve and compile data from DOE facilities. There are several reasons for this, some of which would have existed regardless of who was doing the research. However, some undoubtedly were exacerbated by weaknesses in the interagency effort discussed above.

The fundamental problem was that the worker exposure data had never been collected, processed, or stored with any regard to the possibility that they might be needed in the future for such studies. Retrieving these data would have been a major undertaking under the best of circumstances, but this program was not operating under the best of circumstances. Among the difficulties encountered were the following:

  • Because the data belonged to DOE, HHS would have to make formal interagency requests to have access to them.

  • Since much of DOE’s work is covered by national security restrictions, the next problem was whether the researchers had adequate security clearances or, alternatively, whether the security restrictions could be removed. Determining this is a time-consuming process.

  • Although the data belonged to DOE they were actually under the “control” of the contractors managing DOE facilities. The DOE office responsible for the interagency program had no direct authority over these contractors.

  • Contractors had little incentive to facilitate access to the data because this required the diversion of resources away from their primary mission, and federal

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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contracts were placing increased emphasis on the contractor’s performance in pursuing its mission.

At the same time, DOE was implementing both a new emphasis on environmental safety and health and a significant decentralization of management authority through government-owned, contractor-operated facilities. 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. That fact may also have increased the difficulties in obtaining the data. The list of failed communications, delayed or prohibited access to information, and absent or contradictory responses to information access requests is well documented by NIOSH scientists over a prolonged period between 1992 and 1997. The committee was not provided direct documentation from the perspective of DOE or the contractors, although both former Assistant Secretaries (Dr. Ziemer and Dr. Michaels) who discussed the program with the committee emphasized the difficulties they had experienced pulling together information and gaining the cooperation of many DOE employees, along with the extremely difficult nature of gaining cooperation from contractors who were essentially being asked to respond to an unfunded mandate. It is entirely possible that staff-level scientists may have been less sensitive to the production and other needs of the subcontractors than senior-level management, and it is not clear whether attempts were made to facilitate these communication requests at the site level.

ACERER, in its role as a federal advisory committee to the Secretary of Health and Human Services, was well aware of the extent and nature of the problem, but was empowered to communicate directly only with the HHS Secretary, which it did on two occasions to call attention to the seriousness of the data access problem. In an April 13, 1995, letter from the chair of ACERER to the Secretary of HHS, the chair notes: “Unfortunately, in the fifth year of the Memorandum of Understanding (MOU) between HHS and DOE, access is still a problem.” The letter and the HHS response also illustrate the extent to which agency staff scientists may have been left without senior policy-level support (i.e., the concerns expressed in the letter about lack of NIOSH access to data were prompted by NIOSH scientific presentations and were directed to the HHS Secretary); however, the letter was delegated back down to staff scientists for response and was signed by the program manager, with a very brief cover letter from the Assistant Secretary for Health (June 6, 1995). In a July 18, 2006, letter from a NIOSH section chief to his DOE counterpart, an eight-page attachment lists problems with access and other issues on an item-by-item basis. A follow up letter to ACERER from NIOSH staff (October 26, 1995) indicated that some progress was being made. The committee was unable to find any indication of

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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senior-level communication between HHS and DOE on this topic, which would have been anticipated given the inability of senior-level HHS leadership to correct the problem directly. While specific responses from NIOSH eventually included the development of formal access procedures, this appears to have been accomplished only in 1997. The inability of ACERER to address both DOE and HHS jointly appears to have contributed to this delay.

Against this backdrop, extraordinary efforts were required to develop, implement, revise, and follow through on a coherent research program in order to achieve meaningful outcomes. To the extent that these occurred or failed to occur, both departments share responsibility and both may benefit from a review of lessons learned.

IMPACT OR VALUE OF RESEARCH PROGRAM

Ultimately, the important question is whether the program produced useful information that had an impact on policy and decision making. Even here, there is no agreement. The following example is excerpted from 2006 written communications and, although derived from long response letters, captures the tenor of the relationship. Between the first committee meeting (November 3-4, 2005) and the second meeting (February 21-22, 2006), in response to committee requests to DOE and HHS for information about the impact of HHS research on DOE policy, the following statements were included:

DOE: “There have been no policy modifications as a result of the worker and public health research…” (S. Cary response to committee, January 20, 2006, p. 4).


HHS (ATSDR): “We are not in a position to speak for DOE and say how DOE changed their policy as a result of our work…” (T. Sinks response to committee, February 10, 2006, p. 7).


HHS (NIOSH): “Notice of specific modifications to DOE policies or procedures as a result of NIOSH recommendations under the OERP have not been communicated to NIOSH” (M.K. Schubauer-Berigan response to committee, January 19, 2006, p. 2).

However, in his February 10, 2006, response, Dr. 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. 8). Similarly, former Assistant Secretary for Environment, Safety and Health Dr. Paul Ziemer clarified at the May 3, 2006, committee meeting that DOE sets scientific policy regarding expo-

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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sure standards for workers in accordance with international consensus established by the National Council on Radiation Protection and Measurements and the International Commission on Radiological Protection. To the extent that HHS research contributes to the body of knowledge and to the scientific deliberations involving these bodies, it contributes to those policies. Risk data that comes out of some of the epidemiological studies also contributes to assessments of risk such as the recent BEIR VII report (NRC 2006). NIOSH has contributed to the multinational studies on an ongoing basis and currently has scientists serving as representatives to these bodies.

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.

Measuring Impact

To have measurable impact on occupational and environmental health outcomes, research findings need to be translated into policy changes that are implemented and evaluated. International standards organizations, federal agencies, and organizations such as the National Safety Council have developed approaches based on continuous quality improvement to drive impact. In general, these principles begin with management commitment. Because measuring impact is an ongoing task, the committee feels compelled to comment on aspects of future application of research findings in the context of ongoing operation of DOE facilities, including cleanup operations.

DOE is a major enterprise engaged in research, development, and manufacturing. As such, it will continue to face issues involving worker safety and health, community safety and health, and environmental protection and enhancement and will face a continuing challenge in complying with state and federal regulations pertaining to all these areas. The challenge the DOE faces in dealing with these issues is complicated by two facts. The first is that its major facilities are managed predominantly by contractors. The second is that these facilities are, by their very nature, often working on projects and with chemical substances that have not been evaluated thoroughly, in terms of the health and safety risks they may pose. On the other hand, significant improvements have been made with regard to monitoring for exposure and health impacts of radioactive agents.

In addition to management commitment to a continuous quality improvement program on these sites, other basic components include employee participation, hazard identification, hazard remediation, training, and program evaluation. Whereas site-specific hazards in a given location should be identified and managed at that location, the committee believes that the larger goal of creating

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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sufficient information from large-scale studies to create and implement new policy requires a strong central office. One of the responsibilities of DOE is the compilation, management, and storage of information collected at its facilities regarding worker and community exposures.

As described in previous chapters, both the quality of the scientific research and the scope of the communication activities conducted by HHS under the previous MOUs addressed important, ongoing DOE needs. While significant opportunities for improvement are identified, the scope remains large and federal. Among federal agencies, the expertise for etiologic research into human health effects is located within HHS generally. More specifically, federal scientific expertise addressing occupational and environmental health effects from chronic exposure to low-level radiation, beryllium, and other important exposures on DOE sites has been developed within HHS. Finally, while the committee believes that improved communication between agencies requires greater involvement of DOE in the scientific process, it does not believe that this should entail a return to DOE sole oversight. Public confidence that the health consequences of prior DOE activity will be adequately investigated requires greater independence than would be perceived to be the case with sole DOE oversight. Furthermore, there appears to be no justification for the disruption and added cost that dismantling an established research operation and rebuilding it elsewhere would entail.

After reviewing how to improve the program of the past 15 years, the committee concludes that the preferred arrangement for the continuing worker and public health program at DOE sites is for DOE to maintain a relationship with HHS for this purpose. HHS provides both the expertise and the independence that DOE requires. However, if it is to continue, this relationship needs to be restructured to solve the problems that have appeared over the past decade and a half. The committee concludes that this program should report to the Assistant Secretary level in HHS and the equivalent level in DOE, and it should be a truly collaborative relationship. Both agencies should agree to the study agenda and both should be involved in overseeing the research—HHS overseeing the technical aspects, and DOE ensuring that the work is being conducted according to budget and schedule, that there is rapid and effective feedback of the information being obtained to facility managers as well as the research program, and that there is effective communication with the populations potentially at risk.

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-

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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spector General raised concerns about aspects of DOE and predecessor agencies’ ability to transparently assess the adverse health impacts of those activities on both workers and community members. As described earlier, the transfer of epidemiological research for domestic (but not foreign) outcomes reflected a vote of “no confidence” in DOE scientific capability and integrity.

  1. Science got done; questions got answered. 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.

  2. Credibility was improved. The credibility of the Worker Health program among the affected workers and the public appears to have been improved in the early years after implementation of the MOU, although some dissatisfaction with the HHS agencies appears to have developed over time and within some segments of the affected population.

  3. There was some impact on policy. Although difficult to quantify, there are a number of examples of how the research and analyses conducted under the MOU have influenced DOE decisions and policy. Although many of these influences may have affected decisions at only a single facility the epidemiological studies and dose reconstruction work have much broader ramifications, and add to a knowledge base that has the potential to contribute to international standards and risk analysis procedures.

  4. Further work is needed. The MOU approach for carrying out the worker and public health programs for DOE through HHS partly solved the problems that were building during the time period prior to 1990 in which DOE managed the program internally. Both the quality of the research and the scope of the communication activities conducted by HHS addressed important ongoing DOE needs. Specifically, scientific knowledge that addressed occupational and environmental health effects from chronic exposure to low level radiation, beryllium and other hazardous exposures on DOE sites was developed by the HHS program. Dissemination of these results was extensive. However, the committee found that there were significant opportunities for improvement, as identified in the individual areas of science, communication and management. Scientifically, there are several study areas that have been specifically identified which need to be addressed as well as identifying new areas of health studies based on the continuing remediation and cleanup work that DOE is carrying out. Overall, the committee concludes that improved communication between agencies requires a greater involvement of DOE in establishing and managing the priorities in these studies. However, the committee does not believe that the program should revert to sole management by DOE. Public confidence that the health consequences of DOE activity will be adequately investigated requires this to be done by an

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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independent department such as HHS. Since the MOU approach has worked partially, it seems reasonable to improve it along the lines recommended by this committee, as opposed to starting with a totally difference arrangement which might be disruptive, costly, and not necessarily an improvement.

Although a substantial body of work has accumulated, important work remains. Scientific questions that should be explored through analytic epidemiological studies that include the worker and community populations are outlined in the Chapter 2 recommendations. 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. Studies in progress should be completed and follow-up of exposed workers should continue.

  1. DOE retains the responsibility for protecting worker, community, and environmental health, given that many of these sites remain active and there remain substantial legacy issues at all of the sites.

  2. The process for managing the program can be improved. Although the process established by DOE and HHS may have been appropriate initially, many of the management problems identified by earlier NRC reviews remain, and the management and collaboration process could clearly be improved.

FINDINGS AND RECOMMENDATIONS

1. Review of key scientific studies conducted to date is presented in Chapters 2-4. The Committee finds that there remains critical information to be gathered and assessed. A health program is needed at DOE sites as long as hazardous operations (including cleanup and remediation) continue at these sites. To that end, a mechanism needs to exist for the purpose of developing the research agenda, providing funding for the research, soliciting input into the design, conduct and review of such studies and communication of the results to relevant stakeholders, with clear articulation of the roles and responsibilities of the various parties. In the past, the MOUs between DOE and HHS have served as this vehicle, and could do so in the future. Therefore, the Committee recommends that:

DOE and HHS should sign and implement a new MOU enabling continued work on the Worker and Public Health Activities Program. This MOU should document the responsibilities of DOE and HHS as well as provide the framework for managing the process for interaction and collaboration between DOE and HHS. In addition to incorporating the recommendations made here with respect to managing the program, the new MOU should incorporate the recommendations presented elsewhere in this report.

2. As noted earlier, one of the biggest problems affecting the program has been the difficulty researchers have had in obtaining exposure and other relevant

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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data to use in their epidemiological studies. The fundamental problem was that the worker exposure data had never been collected, processed, or stored with any regard to the possibility that they might be needed in the future for such studies. This situation leads to difficulty in comparing health outcomes with exposure characteristics and in the investigators’ ability to combine information from more than one source in order to increase the power of the studies. As a remedy to this, the committee recommends that:

DOE support the development and integration of a repository for exposure records. The committee recommends that all contractor-assembled data be submitted to DOE’s Office of Environment, Safety and Health for compilation, 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 surveillance (e.g., spirometry, liver function tests, smoker-never smoker), biologic monitoring, and social security number and demographic information (e.g., gender, birth date) on a continual basis for DOE employees, contractors, and subcontractors, for placement in a secure centralized repository. The database would have to be integrated with existing data repositories (e.g., Radiation Exposure Monitoring Systems, Comprehensive Epidemiologic Data Resource [CEDR]). However, unlike CEDR, which facilitates public access to data collected for studies regarding the health impacts associated with working at or living near DOE operations, information compiled in the recommended repository would be available to NIOSH’s scientific investigators or researchers funded extramurally through NIOSH to perform DOE-related health studies. Such a database would be of paramount importance for expanding existing cohort studies or performing nested case-control studies.

3. The quality and integrity of any research program is improved if it is subjected to expert scientific review during its development stage, as the studies in the research agenda are being conducted, and after the results have been gathered by the investigators. In the past, HHS did convene an advisory committee whose mission included the provision of advice and comment (only) to HHS on the OERP. This committee (ACERER) did not have authority to formally communicate its findings to DOE. This circumstance, along with others, resulted in a sense of disenfranchisement on the part of DOE, and only sporadic interest on the part of DOE senior management in the outcomes of the HHS investigations. As a measure of improvement in the future, the Committee recommends that:

A single advisory committee, with a charter issued jointly by DOE and HHS, should be established to review and comment on the research program. Management of the program would be made more efficient if the advisory committee charged with reviewing and providing recommendations on the ele-

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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ments of the research program could report directly to all of the agencies charged with its development, funding, implementation, and translation of results into policies and practices.

4. In the federal government, the success of a program, particularly a scientific research program, is dependent upon the level of attention and oversight given by senior management. At the beginning, as the research program was being transferred from DOE to HHS, the Secretaries of each agency were involved. However, over time, management and oversight responsibilities drifted downward through the chain of command until they became virtually invisible to the most senior levels. The committee therefore recommends that:

DOE and HHS should reestablish and maintain oversight and coordination of the program at the Assistant Secretary level.8 Communication and coordination at a senior level within an organization enhances the probability of success of any program initiative. In this instance, attention given to the program at this level provides greater support to the participating agencies in achieving their mission to protect worker and public health and the environment.

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. While the Committee supports the concept that HHS currently has, and should continue to have, the lead on developing and carrying out the research agenda, it also believes that DOE has a stake in its success and therefore, should participate more substantively in the updating of the research agenda as work goes forward. Therefore, the committee recommends that:

DOE and the relevant HHS agencies should collaborate to update the research agenda annually. It is critical that the resources committed to funding the worker and public health research program be spent in the most efficient manner, yielding the most useful information to understand the potential health and environmental impacts of activities at DOE facilities. Both HHS and DOE can provide important perspectives, based on their extensive experiences in this realm. These collective experiences, along with those contrib-

8

The committee developed and unanimously approved this recommendation prior to a recent reorganization within DOE that merged existing safety and health functions into another unit. Because we believe that occupational and environmental health issues remain critically important to DOE workers and surrounding communities, and because we believe that senior level management engagement is a pre-requisite for effective safety and health program management, the committee recommends that DOE and HHS should establish and maintain oversight and coordination of the program at the Assistant Secretary level in HHS and the equivalent level in DOE.

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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uted by technical experts on the external advisory committee, should result in a more relevant, scientifically sound research program.

6. During the 15 years that HHS has had the lead for the research program, communication between HHS and DOE has been spotty at its best, and non-productive at its worst. 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. To that end, the committee recommends that:

DOE and HHS should establish functional feedback mechanisms to each other for all aspects of the research program. To ensure the greatest level of success for any program of research, a robust program of communication and dissemination about the design and execution of, and results from, a research program should establish linkages not only between the program’s executors and the affected populations, but also between those charged with developing and executing the program. This ensures the probability that the program will be robust, yield useful results, and will be of value in enhancing the scientific basis of our understanding of the potential health and environmental risks associated with DOE facility activities. It also enhances the respective agencies’ credibility and accountability in meeting their governmental responsibilities.

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

ANNEX 6A
ANNEX TABLES

TABLE 6A-1 ACERER Recommendations or Action Items Directed to NIOSH, NCEH, and ATSDR

Meeting Dates

Recommendations or Action Items

Comments

January 1993

Endorsed NIOSH initial listing of research priorities, in principle

Voted to require NCEH, NIOSH, and ATSDR to report annually regarding access to DOE data and personnel, regarding obtaining information pertinent to health and epidemiological research activities. In particular, the report should address problems and limits to access existing information, as well as to collection of descriptive information for future epidemiological and health studies

Committee felt it did not have sufficient information to comment on specifics of priority rankings

April 1993

Endorsed concepts presented in NCEH’s workplan in areas of environmental dosimetry and dose reconstruction, environmental epidemiology, and risk estimation

Committee expressed some concern about proposed laboratory studies and asked for further information on them (no detailed background information on elements of the workplan attached as appendix to minutes or transcripts of this meeting)

December 1993

Electronic data should be placed into CEDR; storage for hard copies of these data should be sought at Washington State University, pending assurances that it has the facilities to keep them properly

Committee endorsed NIOSH’s list of potential radiation issues and future workshop topics, leaving their prioritization to NIOSH:

  1. The energy and geometry of radiation exposures, particularly to organs, as factors in bias and uncertainty of dose estimates

  2. Problems with data collection, abstraction, computerization, and prioritization issues: how these should best be addressed to gather appropriate information for epidemiological studies

Committee added further topics for consideration:

  1. Workshop to identify fruitful interactions, if any, between exposures to ionizing radiation and other hazards such as non-ionizing radiation or chemical exposures, addressing issues such as synergism and antagonism

  2. Workshop (with NCEH) on estimates of uncertain doses (particularly internal) and how these are factored into epidemiological study feasibility. Assess the actual utility of “reference man”

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

 

  1. Calculation of uncertainties associated with internal radiation estimation and its use in epidemiology studies

Recommended that CDC and other agencies establish training monies for this field

Committee endorsed research recommended by NIOSH, with the exception of adding a caution to move slowly regarding biomarkers

Committee endorsed the recommendations (relating to community involvement plans) in the 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”)

  1. Address core data and their storage, as well as compatibility and use across sites of new data

  2. For uniform data, apply thos esolutions found for dose reconstruction problems to epidemiological studies of personnel exposure; add a focus on estimating uncertainties

April 1994

Committee moved to write a letter to Dr. Satcher (HHS) to be forwarded to Dr. O’Toole (DOE) that recognizes the attention and work devoted to the issue of DOE site access and the fact that progress has been made; however, problems are continuing. Structural change is needed to definitively resolve these issues, independent of agency personnel at any given time. This work should be carried out under OSHA (Occupational Safety and Health Administration) regulations

 

July 1994

Scope of advisory committee: “The advisory committee will solicit information necessary to its development of an appropriate research agenda, and make its recommendations to the Secretary of HHS and that these recommendations are

The three motions for these changes passed unanimously:

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

Meeting Dates

Recommendations or Action Items

Comments

 

shared with the Secretary of DOE on all health research issues associated with DOE operations:

  1. “Epidemiological research and exposure assessment of workers at federal nuclear facilities and the collection of surveillance monitoring data for epidemiological purposes.

  2. …(relating tocommunity health studies)…

  3. The committee shall encourage the continued involvement of workers and communities in the planning, conduct, and discussion of such research.

In addition, where related to the scope of the committee’s work as defined above, the committee may request and consider information provided by the HHS agencies on matters such as studies of health service needs and resources for communities affected by DOE operations, public health consultations and assessments, and studies on chemical, biological or physical agents that may have public health significance.”

  • Removed language in scope definition that had ACERER reporting to Secretaries of both HHS and DOE

  • Included language that recommendations to the Secretary of HHS are shared with the Secretary of DOE

  • Inclusion of an exposure assessment element for worker studies, providing parallel activities with community health studies (which included an assessment of exposure)

 

Research addressed by the committee: Drop the “analytic” delineation from the type of epidemiology addressed by the committee

Committee unanimously agreed to this change due to the difficulty in distinguishing between analytic and descriptive epidemiology

October 1994

Creation of a cleanup worker registry including a tracking mechanism, by whatever mechanism deemed appropriate (identification card, etc.). The ACERER chair requested implementation of this recommendation by no later than the second meeting from this one (April 1996 would be the second meeting)

Committee unanimously approved this motion. The ACERER chair, when questioned as to whom the motion to establish a registry was directed—NIOSH or HHS—clarified that the committee advises HHS. The committee would let the agencies determine the best way to implement the recommendation. Dr. Seligman

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

 

Recommend that HHS recommend to DOE that Regulations 85/85A be incorporated into any new DOE contracts

of DOE summarized committee’s intent as a call to address how to track and support workers, possibly through a surveillance program

 

Committee vote on NIOSH Research agenda:

  1. Beryllium worker exposure follow-up—High priority

  2. Job stresses: Medium

  3. Exposure assessment of nuclear waste and cleanup workers: High

  4. Epidemiology of non-fatal injuries and ergonomic disorders in DOE facilities: Low

  5. Predictors of elevated exposure to EMF (electromagnetic fields): High as a confounder

  6. Adverse reproductive outcomes of male workers: High

  7. Previously studied cohorts: High

  8. Case-control study of multiple myeloma at K-25: High

  9. Pantex and Nevada Test Site: Deferred until NIOSH site visit is done

  10. Feasibility of cohort mortality study of DOE chemical laboratory workers: High, if determined to be feasible

  11. Workshop on radiation issues: High

Committee unanimously approved motion and sought to provide a mechanism to address access issues that NIOSH encountered in obtaining records, data, and cooperation from DOE sites and contractors to initiate and conduct studies

 

Committee vote on NCEH research plan:

  1. Environmental dose reconstruction projects: All ranked high priority

  2. Epidemiological research projects: All ranked high

  3. Risk estimation: All ranked high

  4. Interdisciplinary activities: All ranked high

  5. Technical support activities: High

  6. Public involvement in environmental health research: Ranking deferred

 

August 1995

Committee voted that a subcommittee be established to facilitate community input to the ACERER agenda and recommended the addition of atleast two community members to ACERER

 

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

Meeting Dates

Recommendations or Action Items

Comments

 

Recommended that the Secretary of HHS request that funding provisions be presented as a line item in the President’s budget request for federal health activities, and no longer appear in the MOU between the two agencies, in order to enhance the viability and stability of the HHES energy-related epidemiological program

The committee recommended the DOE consider pilot studies to increase utilization of the CEDR database

The committee strongly supported a national registry for cleanup workers involved in DOE nuclear weapons production and testing and at other relevant sites, established by HHS at the earliest possible date and assigned the highest priority, with the necessary administrative and budgetary steps initiated

 

April 1996

CDC should work with DOE-EH and NCI to seek collaboration on all national and international activities in which results of research may complement informative needs of CDC for sites at which dose reconstruction is ongoing or planned. Activities of particular interest would be: (issues 1 and 2 dealt with non-occupational exposures) and 3. Dose reconstructions of inhalation or ingestion of plutonium, strontium, and 131I at the Techa River, Chelyabinsk, and Mayak facility in Russia

Committee voted to adopt an additional paragraph to the ACERER working group guidelines to invite more community participation in order to extensively address community education

Committee discussed research activities supported by DOE outside of the MOU within the U.S.(Center for Risk Evaluation and Stakeholder Participation [CRESP]) and international studies

July 1997

“The HHS Advisory Committee on Energy-Related Epidemiological Research shall request that the Secretary of HHS ask the Secretary of DOE to provide a

 

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

 

mechanism to ensure that DOE contractors adopt and follow NIOSH procedures for research as contained in CFR 42, 85 and 85A”

Committee approved the NCEH research proposals for FY 1998-1999:

  1. Dose reconstruction studies

  • Hanford, Savannah River, and INL (continuations)

  • Marshall Islands (new)

  • Los Alamos (under consideration)

  1. Follow-up on HTDS cohort

  2. Methodological issues development (continuation)

  3. Post-Chernobyl study of thyroid cancer epidemic

  4. Other micronutrient deficiency issues in Russia

  5. Review of coast-to-coast data set of NCI Utah fallout study

Committee requested the Secretary of HHS to work with the Secretary of DOE to establish a formal link between ACERER and the DOE at the secretarial level, and that this linkage be reflected in the ACERER charter and the MOU between the two departments

 

December 1997

A proposal to include in ACERER’s purview DOE activities in the areas of health research, worker monitoring, etc. Move sought to amend a sentence in the draft charter to read: “ACERER will provide advice to the Secretary of HHS to assure appropriate interaction between ACERER and DOE regarding the direction HHS should take in establishing the research agenda, developing the research plan, and for effectively resolving issues concerning the respective roles of DOE and HHS in commissioning and managing health-related activities”

Committee unanimously approved this motion

September 1998

Developed set of recommendations for HHS concerning its research into the occupational and public health consequences of nuclear weapons production and testing activities (the Nevada Test Site [NTS] fallout study):

 

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

Meeting Dates

Recommendations or Action Item

Comments

 

  1. Fulfill the legislative intent of Public Law 97-414

  2. Complete a comprehensive dose reconstruction project for NTS fallout

  3. Notify Americans of the factors that might help them to determine whether they received significant radiation doses from NTS fallout

  4. Create a public health care provider information service on NTS exposures and resulting public health concerns

  5. Support archival projects to document experiences of exposed peoples

  6. Further evaluate screening opportunities for thyroid cancer

 

December 1999

Action item: NIOSH Research/Worker Right to Know Policy: That NIOSH work with ACERER in developing a ‘worker right to know’ policy regarding the potential health risks associated with occupational exposure to workplace contaminants. Policy should be extended to conditions in which epidemiological studies either are not feasible or are likely to be inconclusive. Efforts to communicate with the worker community should commence at the earliest opportunity. The exposed employee should be made aware of the range of uncertainty associatedwith the individual and cohort risk estimates

Response to ACERER request for information on processes that NIOSH uses to inform workers of study results. Previous ACERER discussionsalso sought information on how NIOSH obtains worker input on its studies and for its research agenda

SOURCE: Adapted/assembled from Table A-1 of the NIOSH evidence package and ACERER meetingminutes/transcripts that were included on the CD-ROM accompanying the evidence package (NIOSH 2005).

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

TABLE 6A-2 Consensus Advice and Recommendations from Hanford Health Effects Subcommittee (HHES)

Advice to NIOSH

Advice to NCEH

Advice to ATSDR

Nonspecific Advice

Strengthen ties to NIOSH; requested that NIOSH provide study schedules and protocols to Studies Work Group (9/96)

Request that NIOSH do fullest possible health hazard investigation of 5/97 Plutonium Finishing Plant explosion and send letter to DOE requesting full support for this investigation (10/97)

Recommend specific HHES members to serve as reviewers for NIOSH Construction Worker Mortality Study (4/98)

Assess potential health impacts of agricultural and industrial pollution on Columbia River basin (5/96)

CDC should catalogue data from the HEDR (9/96)

CDC should compile Columbia River use profile (9/96)

CDC should plan for resources to carry out tasks to complete Columbia River review (2/97)

CDC should direct contractor resources to carry out tasks necessary to complete Columbia River review (2/97)

Individual Dose Assessment Project (IDA) and MMP should coordinate use of dose units (2/97)

Recommend several changes in Columbia River dose pathway work (e.g., additions re individual exposure estimate input parameters) (7/97)

Pursue additional work on 1-131 Subregistry (3/95)

Consider linking MMP and I-131 Subregistry (3/95)

Assign lesser priority to analysis of cancer mortality (3/95)

Assign lesser priority to review of Hanford area school children survey (3/95)

Proceed with Phase II of MMP evaluation (3/95)

Develop draft protocol for Birth Outcomes study using HHES input (5/95)

Suggest changes to protocol for Birth Outcomes study (7/95)

Proceed with next phase of MMP evaluation and developing I-131 Subregistry (12/95)

Add African-American representative to HHES (9/94)

Use Gonzaga University as HHES repository (3/95)

Completed outreach package (7/95)

Offered advice on membership recommendation procedures (9/95)

Fill Oregon downwinder seat from existing pool of nominees (12/95)

Preserve public comments verbatim (2/96)

Provide legal opinion reconflict of interest (5/96)

Fill vacant labor seat on HHES (7/96)

Consider continuity of knowledge and experience when reappointing members to HHES (7/96)

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

Advice to NIOSH

Advice to NCEH

Advice to ATSDR

Nonspecific Advice

 

All IDA dose estimates and individual information should be retained with maximum confidentiality (7/97)

Proceed with Plutonium Finishing Plant for Columbia River pathway work (4/98)

Request that HHES and Inter-Tribal Council on Hanford Health Projects (ICHHP) be briefed prior to HTDS press release (12/98)

Request that CDC pursue funding to support HHES inclusion as participants or observers in NRC review of HTDS (12/98)

HHES to send letter to NCEH and DOE urging funding of IDA project at least through end of FY 2000 (12/98)

HHES to send letter to NRC stating that comments re HTDS will be

Approved study protocol for Birth Outcomes Study (12/95)

Cohort for I-131 Subregistry proposed and another, older cohort identified (2/96)

Proceed with Birth Outcomes Study (2/96)

Consensus that HHES cannot currently recommend biomarker use in future studies (2/96)

Add autoimmune diseases to MMP questionnaire (2/96)

Review potential conflict of interest of thyroid expert on medical monitoring panel (5/96)

Advised on MMP eligibility criteria (7/96)

Include Native Americans in MMP (9/96)

Add two to three seats for expertise in toxicology, health care practitioner, and medical sociology (7/96)

Recommend more agency representation at workgroup meetings (9/96)

CDC should inform HHES in advance if CDC representative cannot attend meeting (2/97)

Add vision statement to HHES fact sheet

Make meeting minutes of other HESs available (2/97)

Send material to HHES via regular surface mail (5/97)

Requested budget and expenditure information from ATSDR re HHES, studies, and DOE (7/97)

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

 

forthcoming, urge addition of outside thyroid expertise to panel, and to holding public meeting in Northwest (2/99)

Recommend immediate issuance of press release to emphasize that HTDS results were still draft form (2/99)

HHES to send letter to CDC re support of continued funding of IDA activities past March 2000 deadline (11/99)

Recommend that CDC, NCEH, and ATSDR continue efforts to determine methods and needs for development of combined-dose approach to evaluate doses of I-131 from weapons test fallout and Hanford exposures (11/99)

Work with Washington State to maintain all IDA data, including individual identifiers for future use (5/00)

Define more completely the appeal process for inclusion in MMP (9/96)

ATSDR should determine use of medical monitoring data (9/96)

Use IDA estimates for reevaluation of Columbia River pathway for medical monitoring (9/96)

HHES endorses proposed MMP for thyroid neoplasms and other thyroid and parathyroid conditions (12/96)

Begin MMP as soon as possible (12/96)

Consider other contaminants and exposure pathways for MMP as data become available (12/96)

Do not wait for HTDS results for MMP (12/96)

Ad hoc work group to work with Dr. Spengler re MMP press conference (2/97)

HHES to cosponsor Health of the Hanford Site conference (2/97)

Recommend that chair of HHES compile action list and distribute within 2 weeks (7/97)

Send recommendations to agencies in writing (7/97)

Create historical advice tracking form (7/97)

Send follow-up letters to agencies re open action items (10/97) and letters marked “second request” if no response received (1/98)

Send letter to Division of Financial Operations re funding to support communication with other HESs (10/97)

Ad hoc group to develop packet for new members (10/97)

Notify members of change in meeting dates a minimum of 2 months in advance (10/97)

HHES believes membership is no longer balanced, recommends reviewing candidate pool and

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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)

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

 

 

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)

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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).

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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)

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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)

 

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

The ATSDR should work with ORRHES to

  1. 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

  2. Prioritize all significant activities in a top-down ranking according to the contribution and value to ATSDR in meeting the mission of the ORRHES

  3. Relate available and anticipated funding according to the top-down ranking

  4. Identify short falls infunding and relate this to the top-down ranking

  5. Identify mission components that cannot be funded

  6. 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)

 

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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:

 

  1. The degree to which releases of contaminants from DOE sites contributed to regional public health problems

  2. The degree to which there is a need for additional public health educational services

 

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×
  1. 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

  2. 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

  3. 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)

 

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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)

 

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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).

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
×

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.

Suggested Citation:"6 Program Management Assessment." National Research Council. 2006. Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services. Washington, DC: The National Academies Press. doi: 10.17226/11805.
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Ever since the United States began producing and testing nuclear weapons during World War II, the effects of ionizing radiation on human health and the environment have been a serious public concern. The Worker and Public Health Activities Program was established more than 20 years ago to study the consequences of exposure to ionizing radiation and other hazardous materials from Department of Energy operations to workers and members of the surrounding communities. In 2005, the National Academies convened an expert committee to conduct a review of the Worker and Public Health Activities Program, which is operated by the Department of Health and Human Services (HHS) at Department of Energy (DOE) nuclear facilities under a Memorandum of Understanding (MOU) with DOE.

Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services concludes that the program has used sound research methods and generally has enhanced public understanding of the risks involved. However, the report recommends that more two-way communication between the agencies and workers and members of the public is needed. The report also explores the ways in which the agencies involved could develop a more coordinated, effective, and thorough evaluation of the public health concerns involved in cleanup and remediation activities at Department of Energy sites.

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