B
SPEERA Executive Summary1

In this report, the Panel makes recommendations to improve the quality of the epidemiology program and its value to the Department of Energy, its workers, and the communities near its facilities. This summary contains the Panel’s major observations and recommendations.

Epidemiology provides a scientific evaluation of the health effects of worker and public exposures to potentially harmful materials. It uses health records, exposure records, environmental monitoring records, and personnel records to analyze health effects and to evaluate methods of protection and prevention. The Panel has distinguished between two types of epidemiology: descriptive epidemiology, which includes health surveillance; and analytic epidemiology, which tests hypotheses and often includes long-term research studies.

Over the years, epidemiologic activities have become scattered throughout the Department. Although the main epidemiologic research program is located within the Office of Energy Research, nevertheless, the Offices of Defense Programs and Nuclear Energy also conduct epidemiologic research. The Office of Environment, Safety, and Health is responsible for the data upon which analytic and descriptive epidemiologic research depends. There is no coordination of epidemiologic data collected by the Department’s site operations contractors.

1

SOURCE: SPEERA (Secretarial Panel for the Evaluation of Epidemiological Research Activities for the Department of Energy). 1990. Report to the Secretary. Washington, DC: U.S. Department of Energy.



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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services B SPEERA Executive Summary1 In this report, the Panel makes recommendations to improve the quality of the epidemiology program and its value to the Department of Energy, its workers, and the communities near its facilities. This summary contains the Panel’s major observations and recommendations. Epidemiology provides a scientific evaluation of the health effects of worker and public exposures to potentially harmful materials. It uses health records, exposure records, environmental monitoring records, and personnel records to analyze health effects and to evaluate methods of protection and prevention. The Panel has distinguished between two types of epidemiology: descriptive epidemiology, which includes health surveillance; and analytic epidemiology, which tests hypotheses and often includes long-term research studies. Over the years, epidemiologic activities have become scattered throughout the Department. Although the main epidemiologic research program is located within the Office of Energy Research, nevertheless, the Offices of Defense Programs and Nuclear Energy also conduct epidemiologic research. The Office of Environment, Safety, and Health is responsible for the data upon which analytic and descriptive epidemiologic research depends. There is no coordination of epidemiologic data collected by the Department’s site operations contractors. 1 SOURCE: SPEERA (Secretarial Panel for the Evaluation of Epidemiological Research Activities for the Department of Energy). 1990. Report to the Secretary. Washington, DC: U.S. Department of Energy.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Epidemiologic activities are inherently part of a comprehensive occupational and environmental health program. All the descriptive epidemiologic activities now scattered throughout the Department should be consolidated with the Department’s other health and safety activities. The Panel recommends that the Department establish a strong, comprehensive program by restructuring and expanding the current Office of Environment, Safety and Health. This office should be restructured as the Office of Occupational and Environmental Health and Safety and continue to be directed by an Assistant Secretary. The office should contain a descriptive epidemiologic research component that includes a health surveillance system. When tightly linked with occupational and environmental health and safety activities, epidemiologic activities will give the Department another powerful tool to monitor day-to-day worker health, to measure the performance of health and safety activities, and to guide policy decisions. A recurrent theme of witnesses at every meeting was a lack of credibility in the Department and its epidemiologic activities. The Panel believes that to restore public trust, to assure the highest scientific quality, and to assure the independence of investigators, the Department needs an independent system for managing its analytic epidemiologic research which can transcend changes in Departmental administrations. This can be achieved without statutory changes. The Panel recommends that the Department enter quickly into a Memorandum of Understanding with the Department of Health and Human Services to manage the Department’s analytic epidemiologic research. The Department of Energy would continue to allocate funds for analytic epidemiologic research and the Department of Health and Human Services would use its customary procedures for conducting scientific research, including peer review and open competition for research projects. This analytic research should be managed by one of the Department of Health and Human Services’ epidemiologic research agencies. The quality of epidemiologic research rests heavily on the quality of the data used. Many different programs—industrial hygiene, health physics, environmental monitoring, and medical care—have kept their records separately and in various formats. The Panel recommends that the Department identify a standard minimum set of data, including health and exposure data, necessary for epidemiologic research. These data should be standardized throughout the Department and collected routinely at all facilities. Scientific quality and public credibility are related to the degree of openness with which data are collected, maintained, and analyzed. The Panel values the benefits that flow from allowing independent scientists to examine and reexamine data from different perspectives. Therefore, the Panel recommends that the Department take specific steps toward opening its epidemiologic data to scientific investigators; for example, requiring documentation about data preparation and assumptions; removing personal identifiers from data sets; and establishing new procedures for the timely release of data.

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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services The Panel recommends that the Department make liberal use of committees to foster quality science, to assure independence of research, and to gain participation by outside experts and those who might be affected by the research. The Department has an obligation to communicate epidemiologic findings to all affected people: workers, former workers, and communities. The Panel recommends that communications be prompt, direct, and understandable. People need to know the nature of studies and their results, whether the findings are good, bad, or inconclusive. Beryllium disease is an occupational health risk and should be addressed by the Department’s occupational health program and by the analytic epidemiologic research program managed by the Department of Health and Human Services. The Panel recommends that the Department use a liberal definition of exposure to identify workers throughout its complex who have been exposed to beryllium and who ought to be included in research studies. The Panel also recommends that the Department establish whether beryllium disease may have occurred at facilities other than Rocky Flats. The Department of Energy has shown a continuing commitment to funding energy-related epidemiology. The recommendations in this report will require additional funds for epidemiologic activities. These would be new or reallocated funds above those budgeted for epidemiology in the proposed Fiscal Year 1991 budget. The Panel recommends an additional $4 million for health surveillance and descriptive epidemiology and an additional $1.1 million for analytic epidemiology. The reader should put this summary in perspective by, at a minimum, reading “Introduction: Guiding Principles” to understand the beliefs that guided the Panel.