Long-Awaited Risk Assessment Commission Finally Ready To Convene

After a two-year delay, the congressionally mandated Risk Assessment and Management Commission (RAMC)--originally supposed to get down to business in 1992--is scheduled to convene its first meeting on May 16, according to commission officials. The 10-member RAMC is charged with evaluating current standards and methods of assessing environmental hazards and recommending how that information should be used in regulating toxic substances. Government officials, environmental scientists, and others associated with the field expect the commission's deliberations to have significant implications for researchers and regulators who evaluate and attempt to mediate the dangers posed by environmental hazards. Risk assessment entails characterizing and quantifying the potential harmful effects of environmental toxins on humans, environmental scientists point out. Risk management, meanwhile, adds socioeconomic factors--such as costs and potential job losses--into the process of regulating such toxins (see story on page 4). As part of its mandate, the commission will take into consideration, among other things, a recently published report from the National Academy of Sciences' (NAS) National Research Council (NRC) addressing risk-assessment issues. Carl Mazza, a science adviser in the Environmental Protection Agency (EPA) office of air and radiation who has been coordinating efforts to get RAMC started, says the effect of RAMC's mission on the basic research of environmental scientists in risk assessment may be indirect but important. Although the report may not turn out to be heavily scientific or technological, its significance for researchers may be substantial. The National Research Council's Risk Assessment in the Federal Government: Managing the Process (Washington, D.C., National Academy Press, 1983), defines risk assessment as "the characterization of the potential adverse effects of human exposures to environmental hazards." By contrast, the report says, risk management is "the process of weighing policy alternatives and selecting the most appropriate regulatory action, integrating the results of risk assessment with engineering data and with social, economic, and political concerns to reach a decision." In environmental studies, risk essentially means a broad statistical calculation of probability of harm, after accounting for many factors such as age and sex. For example, the Environmental Protection Agency (EPA) historically has used a lifetime risk--the probability that an individual will develop cancer sometime between birth and death--of 1 in 10,000 to 1 in 1 million in its equations for determining the highest acceptable risk for a toxin. One of the Risk Assessment and Management Commission mandates is to review the appropriateness of EPA's traditional approach for calculating acceptable risk for air toxins. --K.Y.K. "It may have an influence on how critically risk assessment is viewed as a tool in the public policy-making process," Mazza says, adding that the way the discipline is viewed affects "the overall research and development risk-assessment pie." Specifically, he predicts, RAMC will ask such questions as, "What are those areas of risk assessment that require priority development and the most information?" Whatever questions RAMC does end up tackling, says Bernard Goldstein, a committee member and director of the Piscataway, N.J.-based Environmental and Occupational Health Sciences Institute--a joint program of Rutgers University and the University of Medicine and Dentistry of New Jersey--what he hopes to contribute is making "sure that anything we do is firmly grounded in good science." RAMC was created by 1990 amendments to the Clean Air Act of 1972, which require the panel to "make a full investigation of the policy implications and appropriate uses of risk assessment and risk management in regulatory programs under various Federal laws to prevent cancer and other chronic human health effects which may result from exposure to hazardous substances." The current 10-member commission is composed of leading scientists and other figures in academia, business, government, and public policy. Three of the members are presidential appointees, six were appointed by Congress, and one was named by NAS (see story on page 11). The commission was to have its first meeting two years ago, but because nominations for appointees came in slowly, and because of the transition in presidential administrations, the panel did not meet its deadline, say government officials. Risk-Assessment Issues While RAMC's mandate was made clear in the Clean Air Act amendments of 1990, observers agree that the commission's task will be complicated by controversial issues currently under scrutiny in the field of risk assessment and management that are broader than originally mandated. Risk researchers are at a crossroads in terms of reevaluating their methods and standards, their funding, and communication with policymakers and the public, say government advisers. Mazza says that the delay in RAMC's start makes the forthcoming May meeting coincide with "a time when issues of this sort are front and center on [Capitol] Hill." The release of the NRC report--as well as a significant report from the Office of Technology Assessment--is indicative of the recent flurry of activity surrounding environmental risk assessment. The NRC report--entitled "Science and Judgment in Risk Assessment," published in January and also mandated by the 1990 Clean Air Act amendments--evaluates the methods and assumptions used by EPA for estimates of risk. The OTA report--entitled "Researching Health Risks" and published last November--was requested by the House committees on Energy and Commerce and on Science, Space, and Technology to analyze the attention and resources allotted to health risk-assessment research. The Risk Assessment Management Commission is composed of three presidential appointees, one National Academy of Sciences (NAS) appointee, and six congressional appointees. Two of three members appointed by President Bush have been replaced by appointees of President Clinton. Under the legislation establishing the commission, the congressional appointments were made by the following legislative leaders: two members by the speaker of the House, one member by the minority leader of the House, two members by the majority leader of the Senate, and one member by the minority leader of the Senate. The commission members are: Norman Anderson, American Lung Association of Maine, appointed by Sen. George Mitchell (D-Maine); Barbara A. Bankoff, president of Bankoff Associates, a policy consulting firm in Washington, D.C., appointed by President Bush; Peter Y. Chiu, a physician based in Palo Alto, Calif., appointed by President Clinton; John Doull, a professor of toxicology and pharmacology, University of Kansas Medical School, Kansas City, appointed by Sen. Robert Dole (R-Kans.); Bernard D. Goldstein, director of the Environmental and Occupational Health Sciences Institute, Piscataway, N.J., appointed by Frank Press, former NAS president; Allan C. Kessler, an attorney at Buchanan Ingersoll, a law firm in Philadelphia, appointed by Clinton; Joshua Lederberg, University Professor, Rockefeller University, New York, appointed by Rep. Thomas S. Foley (D-Wash.); Gilbert S. Omenn, dean of the University of Washington's School of Public Health and Community Medicine, Seattle, appointed by Foley; David P. Rall, former head of the National Institute of Environmental Health Sciences, appointed by Mitchell; and Virginia V. Weldon, vice president of public policy, Monsanto Co., St. Louis, appointed by Rep. Robert Michel (R-Ill.). Involved constituencies both agree and disagree on many areas of risk assessment and management, Mazza says. For example, he explains, there is much consensus among interested parties-- politicians, scientists, industry, and special-interest groups-- on requiring industry to install and use the best available pollution-control technology; however, groups are divided on how to assess risk from residual emissions, after the best available technology is in place. The debate has reached the point "where rooms full of senators were getting lectures on risk assessment to try to figure out what should be the appropriate test for risk," Mazza says. This climate prompted the inclusion of a provision for RAMC in the 1990 amendments, he says. Regarding EPA's role, Adam Finkel, a member of the NRC committee and a fellow at Resources for the Future--a Washington, D.C.- based environmental advocacy organization--says, "EPA is, in our opinion, striking a very thoughtful approach to using scientifically reasonable assumptions and improving them as time goes on. But some of our recommendations were aimed at improving the gaps in EPA's process" of assessing risk. Determining how those gaps in information might be filled, say environmental scientists, may consume much of RAMC's attention. Warner North, an environmental scientist and senior vice president of Decision Focus Inc., a consulting firm located in Mountain View, Calif., says RAMC has an opportunity--with information from both reports--to write recommendations on how risk assessment could be improved by providing a better basis in science. In testimony before the House Subcommittee on Technology, Environment, and Aviation in March, Ellen K. Silbergeld, a senior toxicologist with the Environmental Defense Fund (EDF)--another Washington-based environmental group--and a professor of epidemiology at the University of Maryland Medical School in Baltimore, agreed with the findings of the NRC and OTA reports that current risk methods were inadequate. Silbergeld, also a member of the EPA Science Advisory Board, said in regard to the reassessment of dioxin risks, the board "found a need for a broader range of risk-assessment approaches, rather than codification of current methods, with all their limits." According to Silbergeld, these approaches also should include two methods not currently used in risk assessment: (1) monitoring--as opposed to modeling--direct sampling of such ecosystem components as wildlife, food, drinking water, and human tissues, and (2) surveillance--gathering such data on affected populations as disease and death rates of human populations and reproductive success in wildlife populations. Finkel says both the NRC and OTA reports imply that questions brought up by the review of risk assessment will not be wholly "answered by traditional [risk] disciplines of toxicology and epidemiology, but also by [fields such as] molecular biology and molecular biochemistry." For example, he says, risk assessors are hoping for "specific information that would allow them to predict risk on the basis of the actual biological mechanism rather than the linearity assumption," a model for extrapolating effects of toxins from high doses to low doses. However, North points out that there could be "technological hindrances" for basic life scientists working with toxic chemicals, such as arsenic and benzene, because these chemicals cause different responses in animals compared to humans. He speculates that with tools such as transgenic mice being developed, more useful models to combine basic and risk- assessment research are imminent. The research underlying risk assessment is not the only issue under the microscope; funding for risk assessment is also being scrutinized. For example, Dalton Paxman, a toxicologist and project director for the OTA report, says his agency found "an inverse correlation between resources and mandates" involving risk assessment. Specifically, from 1981 to 1991, the proportion of federal funds devoted to environmental health R&D relative to health R&D (based on data from the National Institutes of Health) decreased from 6.8 percent to 4.9 percent, while in that same period the number of environment-related mandates that Congress passed increased. In addition, according to the OTA report, the entire area of methodological research in risk assessment --developing models for testing factors such as toxicity and exposure levels of toxins--is underfunded. This area, one that is likely to have the farthest-reaching effect on policy, received about $65 million in 1993, about 11 percent of the $600 million spent by the government on health risk-assessment research. NRC committee vice chairman Arthur Upton agrees, saying, "It would make good sense to spend a little money, relative to the billions, to buttress the data to make risk assessment less uncertain."

Long-Awaited Risk Assessment Commission Finally Ready To Convene

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