Risk Assessment Commission Identifies Daunting Challenges

Challenges Author: KAREN YOUNG KREEGER, pp.1 Date: June 27,1994 The members of the Risk Assessment and Management Commission (RAMC), which held its first meeting last month in Washington, D.C., apparently have their work cut out for them. Hampered by a two-year delay in its formation, the commission faces a November deadline to fulfill its congressional mandate to evaluate current standards and methods of assessing environmental hazards and to recommend how that information should be used. Complicating that task and one of the first priorities for the 10-member panel, according to some of the commission members and other observers, is the need to define more specifically the parameters and goals of RAMC's charge. At stake in the commission's deliberations is more than just a blueprint for Congress and public policymakers to follow in determining and regulating such environmental hazards as air pollution and toxic wastes, says RAMC chairman Gilbert Omenn, elected by the commission members as one of the first orders of business at the meeting. Omenn, dean of the School of Public Health and Community Medicine at the University of Washington, says that risk assessment and management affect broad areas of the scientific community. "Risk assessment, at its heart, depends on advances in basic sciences, in the understanding of mechanisms, and in the documentation of exposures at sites of action, such as organs and tissues," he says. "Modern molecular technology has raised expectations among public-health officials and environmental regulators that biomarkers of effect, of exposure, and of individual variation in susceptibility will be usefully applied to studies of humans." Omenn adds, "Social scientists have a large role to play, also, since conceptual approaches and practical techniques for communicating with many kinds of stakeholders are essential for effective risk reduction and protection of health and the environment." Given RAMC's far-reaching mission, the November deadline set by Congress for the commission to report its analyses and recommendations is a challenge, Omenn acknowledges. Although he has not said whether this date would be moved, Omenn does say that the commission "would need to develop a full scope of work that is realistic." "There's no deadline change right now," says Carl Mazza, liaison to RAMC from the Environmental Protection Agency (EPA) office of air and radiation, and not a commission member, "until [the commission] figures out what they need in terms of time and until they communicate that message to [the Clinton administration] and to Congress. It's up to the commission members how they want to handle this." "I'm encouraged that we're finally meeting," says John Doull, a commission member and a professor of toxicology and pharmacology at the University of Kansas Medical School in Kansas City, referring to the fact that the commission was originally supposed to convene in 1992 but was delayed until last month. According to government officials, several factors, including the transition between the Bush and Clinton administrations, caused delay in appointing members. The commission was created by 1990 amendments to the Clean Air Act of 1972. Composed of eminent scientists in toxicology and epidemiology and other leaders in academia, business, and government, RAMC was formed through three presidential, one National Academy of Sciences, and six congressional appointments (K.Y. Kreeger, The Scientist, May 2, 1994, page 3). Ostensibly, RAMC's all-encompassing charge is to address the appropriateness and feasibility of--as well as uncertainties and policy issues surrounding--the development of a consistent methodology or standard for risk assessment. "Ours is not a strictly scientific task. It also includes social values and public-policy issues," says Omenn. According to the Clean Air Act amendments, RAMC is supposed to include in its evaluation risk assessment and management activities "in regulatory programs under various Federal laws to prevent cancer and other chronic human health effects which may result from exposure to hazardous substances." But some of the meeting participants and others express concern that the issues the panel is looking into, as well as RAMC's role, need to be better defined for the commission to be successful. Ellen Silbergeld, a senior toxicologist with the Environmental Defense Fund--a Washington, D.C.-based advocacy group--and a professor of epidemiology at the University of Maryland Medical School, gave a presentation at the meeting. Silbergeld, who is not a commission member, says that RAMC "has a somewhat confused sense of purpose in that it's not completely clear what it's about, in terms of [being] yet another commission to look at risk assessment or [trying to] bridge the gap between assessment and management." Although she says the commission "has a potential to make a contribution," Silbergeld still is skeptical about the overall impact RAMC may have. "A concern I have about all these creations like the RAMC is that to some extent they reflect [either] the nave hope or a sly technique to look toward some sort of science panel to solve the problems of environmental policy-making, which in my opinion is largely political." "The mandate is pretty broad, and eventually we'll have to pick out specific areas and concentrate our recommendations to make a bigger impact. We don't want this to be just another report," says commission member Peter Chiu, a physician with the Kaiser Permanente Medical Group in Milpitas, Calif., and an assistant clinical professor at Stanford University's School of Medicine. Doull says his impression of what the commission is supposed to do is "not to reinvent the wheel," but rather to "develop a new approach to risk assessment." Because most of the attention in risk assessment has been on cancer-causing toxins in the environment, Silbergeld says, "I tried to suggest some areas that have not been dealt with adequately. One is the continuing neglect of how we're going to assess the risks of non-carcinogens," such as lead and solvent chemicals, that can have neurotoxic effects and can cause reproductive damage. Doull says that he and the committee agreed in principle with Silbergeld that non- cancer risks should be addressed more prominently. Another non-commission member, Elizabeth M. Whelan, president of the American Council on Science and Health, a New York-based consumer-education organization, has a cautious view of what issues RAMC will really address. "I've seen mandates like this at various agencies, for example at the EPA, but then you find out in print that it really only applies to things that are within their control," she says, referring to her doubt that RAMC will consider causes of risk to human health that are not normally considered environmental hazards, such as tobacco smoke. However, according to Omenn, "There is a clear sense throughout the agencies and the commission that our mandate calls for looking quite broadly at risk assessment and management decisions. This is not at all an EPA-bounded problem." The next RAMC hearing, which is open to the public, is scheduled for June 30 at the Hyatt Regency Hotel in Washington. Upcoming meetings are tentatively slated for July 29, September 9, and October 21, Mazza says. Meeting dates will be announced in the Federal Register.

Risk Assessment Commission Identifies Daunting Challenges

Interested in reading more?

Become a Member of