This committee was constituted in the Fall of 2005 at the request of the Department of Energy (DOE) to review the Worker and Public Health Activities Program operated by the Department of Health and Human Services (HHS) at DOE nuclear facilities from 1990 to 2004. The program responsibilities were defined in three Memoranda of Understanding (MOUs) signed at the secretarial level between these departments in 1990, 1996 and 2000. The National Institute for Occupational Safety and Health (NIOSH), which carried out a portion of this program, called it the Occupational Energy Research Program (OERP). Other HHS organizations that were involved in carrying out parts of this program during this period were the National Center for Environmental Health (NCEH) and the Agency for Toxic Substances and Disease Registry (ATSDR) (beginning with the 1996 MOU).
Funded at approximately $10 million to $20 million annually for more than 20 years, DOE’s Worker and Public Health Activities Program was established to study the consequences of exposures to ionizing radiation and other hazardous materials used in DOE operations on workers and the general public in surrounding communities. Initially, the program was managed solely by DOE.
The National Academies’ committee was charged both to review the quality of the program and to make recommendations for future improvements. The committee reviewed the HHS agencies’ research priorities, research project selection, usefulness of results, and dissemination of completed research. To evaluate the quality of the programs from the viewpoint of science, public policy, and the dissemination and communication of results to workers and the public, the committee used a sampling strategy that reviewed selected studies from three
DOE sites and, in some cases, multisite studies or products that were not site-specific. The Statement of Task and Sampling Strategy follow:
STATEMENT OF TASK
DOE’s Office of Health requested that a committee be created by the National Academies to conduct a review of the Worker and Public Health Activities Program to assess and recommend ways to enhance the program’s scientific merit, focus, and effectiveness; its impact on the DOE’s policies and decisions; and other program benefits, including the relevance to DOE’s mission, that are consistent with the objectives of this program. In addition, the National Academies’ committee was asked to address the following aspects of the program:
The congressional mandate in establishing the MOU, and how well its goals have been met through FY 2004;
Evaluating research priorities for projects from FY 1990 through FY 2004 and for projects included in the agenda;
Research project selection from FY 1990 through FY 2004 and for projects included in the agenda;
Usefulness of results and dissemination of completed research through FY 2005; and
Other aspects to be identified by the committee.
The committee was asked to propose other appropriate measures or indicators to be used in evaluating this program. DOE also requested the committee’s assessment, given sufficient information and time, whether or not the individual Centers for Disease Control and Prevention (CDC) agency programs were of the highest quality from the viewpoint of science and public policy.
In considering the Statement of Task in the context of the size of the program, the number of DOE nuclear sites, and the variety of activities at these various sites, the committee determined that a comprehensive assessment of the entire program was not possible in the time allotted for this study. The committee determined that a sampling strategy would be needed.
Accordingly, the committee discussed various subsets of the total program to review and arrived at a selection rationale that took into account the following factors:
The range of time over which health studies were initiated.
The number of workers involved as part of the program.
A variety of types of dissemination and communication challenges.
A variety of security challenges.
Size of the surrounding public community.
Geographic distribution of the sites.
With these factors in mind, the committee selected three DOE nuclear operations sites, Hanford, Oak Ridge, and Los Alamos, as a subset of the total DOE sites on which it would focus its attention. The committee also recognized that it would have to go beyond these sites to look at certain aspects of the program, such as the technical studies (some of which were multisite studies that included more than these three sites) or the program management process which also reached beyond the three sites.
In addition to this sampling strategy for site-specific aspects of the program, the committee requested and considered detailed information from the agencies on broad aspects of the program. These topics included, for example, identification of project categories and specific studies funded by DOE and produced by the three HHS agencies, information on the DOE/HHS budgeting processes, procedures used in the establishment of project priorities, and program management processes for the overall program.
The committee concludes that HHS agencies have made significant contributions to this program and that their continued participation will contribute to the future success of DOE activities at its facilities. Nevertheless, substantial opportunities exist to make the program even more effective, as shown by the following findings and recommendations.
ASSESSMENT OF PROGRAM MANAGEMENT ISSUES: STRENGTHEN THE MOU TO UTILIZE THE UNIQUE STRENGTHS OF DOE AND HHS TO INCLUDE THE FOLLOWING ELEMENTS
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. The committee found that the MOUs, while setting up an overall operating structure for the worker and public health program at DOE, stopped short of defining specific operating elements that, if implemented, could have improved results and the effectiveness of the program in addressing the health needs of workers and the public. As of the writing of this report, the latest MOU remains unsigned by HHS.
The committee further concluded that a worker and public health program was needed for the continuing hazardous cleanup and remediation operations at DOE sites that may result in exposures to ionizing radiation and radioactive materials. In addition, the program should continue to be operated by HHS to minimize concerns that it was influenced by DOE. The MOU framework pro-
vides a useful mechanism for an inter-Departmental program such has as the health program.
Findings and Recommendations
1. The Committee has concluded 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. 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 Research 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. As noted above, a health program is needed at DOE sites as long as hazardous operations continue. Studies in progress should be completed and follow-up of exposed workers should continue.
2. One of the biggest challenges affecting the program has been the difficulty researchers have had in obtaining exposure and other relevant data to use in their epidemiological studies. Common data collection protocols and standardized data are needed for epidemiology and public health 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 Health1 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), biological 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.
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 (the Advisory Committee for Energy-Related Epidemiological Research) 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 elements 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.2 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 contributed 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 intermittent at best, and non-productive at its worst. To ensure better coordination among the agencies 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.
The elements recommended above should be incorporated in an MOU that will govern the continuing health program at DOE sites and that should operate as long as hazardous work (including cleanup and remediation) is carried out at these sites.
SCIENTIFIC PROGRAM ASSESSMENT: FOCUS AND EXTEND SELECTED SCIENTIFIC STUDIES
The scientific studies within this program ranged from the development of new knowledge regarding exposure versus health effects to the application of existing and new methodologies for assessing the impact of exposures to hazards resulting from DOE operations on workers and the public living near DOE facilities.
National Institute for Occupational Safety and Health (NIOSH)
Continued research into the health of the past and current DOE workforce benefits DOE in three major ways: (1) it assists DOE in fulfilling its obligations to its employees to provide the best possible information about the health consequences of their employment, (2) it enhances methods to reconstruct past exposures, and (3) it contributes directly to the scientific knowledge base regarding protracted low-dose-rate exposures to radiation that are relevant to the protection of populations both in the United States and elsewhere.
Findings and Recommendations
1. The committee noted in its review of the NIOSH program that several large studies remain unfinished. The committee therefore recommends that:
NIOSH should complete three major unfinished studies: the multisite leukemia case-control study (in preparation for publication at the time of this report), the K-25 multiple myeloma case-control study, and the chemical workers study. The remaining unfinished studies should be evaluated and prioritized by NIOSH and DOE for future funding decisions.
2. As noted earlier, “one of the biggest challenges affecting the program has been the difficulty researchers have had in obtaining exposure and other relevant data to use in their epidemiological studies.” Therefore, the committee further recommends that:
DOE should consider developing a process that captures current exposure data, including external radiation exposure, internal radiation exposure, chemical exposure, and other demographic information (e.g., gender, age, social security number) on a continual basis for DOE employees, DOE contractors, and DOE subcontractors, for placement in a centralized repository (see recommendation 2 under Assessment of Program Management Issues above).
3. The committee finds that continued research into the health of the past and current DOE workforce benefits DOE by enhancing methods of reconstructing past exposures and that the continued development of such methodology is
important to the evaluation of worker and public health effects at the DOE sites. The committee therefore recommends that:
Further investigation into the utility of novel methods to reconstruct dose, such as fluorescence in situ hybridization, the glycophorin A somatic mutation assay, in vivo electron paramagnetic resonance of teeth, and other promising biological markers, should be given a high priority. The development of such markers, especially if the sensitivity of the methods can be improved, would be useful, particularly in the validation of estimates of external dose. In addition, NIOSH should continue to support methodological studies that address statistical issues such as the effects of systematic errors in the personal dosimeters, the truncation of dose from badge readings, and the effects of dosimetric uncertainties upon epidemiological studies.
4. The latest published follow-up for any of the DOE cohorts ended in the mid-1990s when considerably more than half of the participants in these studies were still alive. Therefore the committee recommends that:
There should be follow-up of existing DOE cohorts for cause-specific mortality.
5. Deficiencies in data quality or the percent completeness of radiation dose should be resolved before undertaking further pooled analyses. Therefore, the committee recommends that:
A phased approach toward further pooling of DOE and international nuclear workers studies should be undertaken. The initial phase would be for NIOSH to provide a justification for pooling particular DOE sites and cohorts based on the completeness and accuracy of radiation exposure data and on the site-specific potential for confounding between measured external radiation exposures and unmeasured (e.g., internal doses, chemical, asbestos) exposures.
6. NIOSH conducted nested case-control studies to better address confounders and to seek to improve information on internal exposures to radiation and other exposures. The committee finds that planning of additional nested case-control studies of solid tumors should include the following:
The scientific advantages and disadvantages of developing both combined analyses of risk for all solid tumor sites and of separate analyses of specific tumor types should be carefully assessed.
The quality of the data on smoking that will be available in the case-control studies on a site-by-site basis should be assessed carefully.
Realistic power calculations should be obtained.
The likely value of job exposure matrix-based methods for retrospectively assigning exposures to chemicals, asbestos, and other workplace toxicants should realistically be assessed.
7. Starting in 1994, the CDC-supported National Program of Cancer Registries has provided funds and oversight for the development of cancer registries in all 50 states. These registries provide the opportunity to link future follow-up of the DOE cohorts to state cancer registries to identify incident cancers in this population for a follow-up period beginning in the mid- to late 1990s. An intramural NIOSH project examined population-based state cancer registries to determine their feasibility and suitability for occupational studies. Despite limitations in statewide cancer registry systems, the study concluded it was feasible to use many statewide registries for occupational health studies. The committee therefore recommends:
The establishment of linkages between existing cohorts and the 50 state cancer registries.
8. The committee finds that the NIOSH extramural and intramural programs have not been highly productive in terms of contributions to the peer-reviewed literature. Therefore, the committee recommends that:
NIOSH should increase substantially the number of intramural scientific research findings that are submitted to high-quality scientific journals.
9. Future studies:
The committee concludes that future studies should represent all categories of workers (e.g., contract cleanup workers and others) on DOE sites with potential exposures. These future studies should also include diseases in addition to cancer. The committee recommends that:
As these questions surface in the future, NIOSH and DOE explore the possibility of addressing them through studies that utilize DNA from DOE workers diagnosed with cancer and from controls. To facilitate these future studies DOE and NIOSH should consider the following:
Establishment of a database of workers with appropriate data to facilitate follow-up and to evaluate potential confounders (e.g., see recommendation 2).
Development of valid methods to identify non-cancer health outcomes including the use of periodic questionnaires, and specific diagnostic tests (e.g., pulmonary function).
Support for the continuance of biorepositories such as that funded by ATSDR that archive specimens such as blood and DNA to support future studies.
National Center for Environmental Health (NCEH)
The NCEH program has provided valuable data to communities about the historic operations of DOE facilities and their consequences in terms of health and environmental impacts. The dose reconstruction methods for radiation and chemicals that have been developed, applied, and refined in the NCEH studies have been accepted widely and are being used in epidemiologic studies worldwide. For example, many of the tools and techniques developed in the Hanford Environmental Dose Reconstruction Project are being used to reconstruct the doses from atmospheric releases from nuclear weapons production activities at the Mayak facility to the residents of the city of Ozersk, Russia.3
Findings and Recommendations
1. The Los Alamos Historic Document Retrieval and Assessment project at Los Alamos is the sole remaining dose reconstruction activity of NCEH and the public would benefit from the information derived from this activity. Therefore the committee recommends that:
NCEH complete this project as expeditiously as possible and provide as much evaluation of the compiled data as feasible to inform the public regarding historical doses and risks.
2. The NCEH program has conducted dose reconstruction studies that are independent of DOE. These studies have provided valuable data to the communities surrounding DOE facilities in particular, and to the public in general, about the historic operations of those facilities, the environmental impacts, and the doses or health risks of individuals exposed to releases from the site. Therefore, the committee recommends that:
NCEH continue to make the findings of its dose reconstruction studies available to the public on-line, ideally including a direct link to the study results from the facility’s web site.
In the event that any further dose reconstructions at DOE sites are required, the committee recommends that NCEH or some other agency independent of DOE should manage and direct the studies and the funding for the studies should be provided by DOE.
Agency for Toxic Substances and Disease Registry (ATSDR)
ATSDR produced valuable products under the various MOUs. In particular, the Public Health Assessments (PHAs) and Toxicological Profiles have potential
http://www.eh.doe.gov/health/hstudies/russian_health.html. Last accessed October 2006.
value to the communities surrounding DOE sites. In 1997, ATSDR began submitting DOE public health assessments for peer review. The committee supports the continued peer review of these documents in the future.
Findings and Recommendations
1. The PHAs are presented in such a way as to have potential value to the communities surrounding DOE sites. Some of this utility has been compromised by the public’s reaction to ATSDR’s use of a threshold for radiation effects. As a result, the committee recommends the following:
In light of ATSDR’s mandate to adopt and apply conservative assumptions, the committee recommends that ATSDR should reevaluate its use of a radiation risk threshold.
2. ATSDR has completed 20 PHAs addressing 22 DOE sites on the Environmental Protection Agency’s National Priority List. ATSDR is currently working on five remaining DOE sites, Hanford, Brookhaven, Los Alamos, Savannah River, and Oak Ridge. The committee concludes that the PHAs have potential value to the communities surrounding DOE sites. As a result, the committee recommends the following:
DOE funding of ATSDR activities at the five DOE sites should continue.
EVALUATION OF DISSEMINATION AND COMMUNICATION: IMPROVE DISSEMINATION AND COMMUNICATION OF RESULTS TO WORKERS AND THE PUBLIC
In reviewing the dissemination and communication efforts of this program, the committee observed various types of information dissemination but few examples of effective communication with workers and the public at or near DOE sites. For the purposes of this report and consistent with its statement of task, the committee drew a distinction between dissemination and communication in its review. Dissemination is a one-way process—to send information out widely, to publicize or broadcast information. This term was specifically used in the charge to the committee. However, the committee judged that to truly evaluate public understanding of health effects, as described in the MOU, it also had to look closely at the communication efforts of the HHS agencies. Communication implies a two-way process—an interchange of knowledge, thoughts, and opinions. The committee’s recommendations result from findings of shortfalls in effective communication to affected citizens and workers.
Open communication that involves dialogue among the agencies, workers, advisory bodies, and the public is critically important to improve relationships among management, workers, and communities in which DOE sites are located.
Findings and Recommendations
1. Efforts to disseminate results to citizens and workers at DOE sites by HHS agencies were extensive and benefited the target audiences by giving them needed information about health risk issues. As a result, the committee recommends the following:
HHS agencies should be the continuing main source of active risk communication and education programs at DOE facilities due to significant evidence of continuing distrust of DOE and its contractors. DOE should work with the HHS agencies, its own contractors, and citizens’ advisory boards to try to gain back trust in communities near its facilities with its own open, two-way communication efforts.
Dissemination and communication efforts should be coordinated among the federal agencies involved as long as such coordination does not affect trust issues for HHS agencies among workers and citizens in and near DOE facilities.
2. While HHS information dissemination was generally laudable, communication activities related to worker and public health were variable in quality and uneven, agency to agency. Guiding principles for effective risk communication and best practices recommended in previous studies of other nuclear and hazardous operations could be applied to improve efforts to communicate the risks involved at DOE sites to both workers and community groups. As a result, the committee recommends the following:
Both DOE and HHS agencies should develop improved long-term communication plans that incorporate risk communication lessons learned during the past 15 years from scholars and practitioners (including those at these agencies). These improved communication plans should continually be updated and reviewed by outside risk communication experts every few years.
DOE and the HHS agencies should support their communication activities at DOE facilities with significantly increased organizational, financial, and personnel assistance.
3. While the committee recognizes difficulties inherent in communicating about risk to the public directly or in a public participation process, it believes that open communication involving dialogue among the agencies, workers, advisory bodies, and the public is critically important and needs improvement. As a result, the committee recommends the following:
DOE and the HHS agencies should specify in their improved risk communication plans how they hope to achieve more effective, open, two-way communication about health risks associated with cleanup activities as
well as continuing or new missions at DOE facilities. Risk communication research on how best to incorporate public participation and work with citizen groups should be applied to these plans, with a reminder that the specific best practices at one site might not necessarily be the best practices at another site. Agendas for public and worker meetings should be developed in concert with citizen and worker representatives to ensure that stakeholders’ concerns and opinions are treated with respect and responded to seriously.
The Hanford Community Health Project directed by ATSDR should be continued to ensure good public health information at that site, particularly during cleanup activities. Similar projects should be established at other DOE sites where serious health effects issues exist.
DOE Site-Specific Advisory Boards (SSABs) have been an important communication element at DOE sites. These should be continued as long as cleanup work continues at the sites and can be improved by including ex officio representatives from both DOE and HHS agencies.
Similarly, the Health Effects Subcommittees (HESs) were a very important communication element and should be reconstituted at DOE sites where serious concerns about health effects issues exist.
All SSABs and any reconstituted HESs should have a subcommittee that reviews and recommends actions on risk communication to workers and the public. This subcommittee should work with DOE and HHS agencies to provide overview, feedback, and advice on communication activities. To further these goals, these subcommittees should add a communication professional as a member, if there is no such person already on the group.
4. There has not been enough outside evaluation of the communication aspects of the HHS programs. Best practices in risk communication require professional evaluation, particularly to meet the needs of different stakeholders. As a result the committee recommends the following:
HHS agencies and DOE should engage in periodic and systematic evaluations of their communication efforts using the most current risk communication research and practices available. These evaluations should include development of a framework to assess the effectiveness of their communications to stakeholders, and be conducted by both internal and external evaluators.
Evaluations should assess the quality of the communication products, effectiveness of dissemination, and most importantly, how information is interpreted, perceived, and accepted by the affected communities and workers. To ensure that the most current risk communication research and practices are being applied and necessary adjustments are made, internal evaluations should be done yearly and external evaluations should be done at least every 3 years.