Federal Commission Proposes Risk Management Framework

By Amy Charlene Reed, RiskWorld staff
E-mail to: reed@tec-com.com.

Members of the federal Commission on Risk Assessment and Risk Management say that they hope the centerpiece of their just-released draft report will become a blueprint for risk managers across the nation.

"Our goal is to propose a system that will be the 'Red Book' of risk management," said Commission member Norman Anderson, referring to the National Academy of Sciences' 1983 report Risk Assessment in the Federal Government: Managing the Process that presented the now universally accepted four-step paradigm for risk assessment. Anderson, the director of the American Lung Association in Maine, added, "We want this report to be a dynamic working document, an actual organic connection with decision-making processes at all levels from small communities to the federal government."

Though the Commission's report Risk Assessment and Risk Management in Regulatory Decision-Making also makes significant recommendations regarding risk assessment, its proposed risk management framework is the heart of the document.

"Many reports have been written about ways to improve risk assessments, but very few have addressed what you do with the risk assessment, which is the whole point," said the Commission's executive director, Gail Charnley. "The goal after all is risk reduction, not developing defined quantitative descriptions of risk."

Report's impact expected to be substantial

Already, more than 2,000 people have requested copies of the Commission's draft report, which was released to the public on June 13 and is expected to have a major impact on the nation's risk assessment and management at the federal, state, and local levels. Federal agencies such as the U.S. Environmental Protection Agency are expected to respond to many of the report's recommendations, members of Congress are expected to consider the report when drafting future legislation, and local and state representatives, particularly those who testified before the Commission, are expected to review the report.

Congress mandated the creation of the Commission as part of the 1990 Clean Air Act Amendments when questions raised about risk assessment and management during the drafting of the legislation were left unanswered. The Commission consists of 10 members appointed by Democratic and Republican leaders in the U.S. Senate and U.S. House of Representatives, by President Clinton, and by the National Academy of Sciences. Its chairman is Gilbert S. Omenn, dean of the University of Washington's School of Public Health and Community Medicine in Seattle and a former deputy science and technology adviser in the White House Office of Science and Technology Policy. He has been described by sources close to the Commission's work as its "driving force."

"The Commission originally came about because of disagreement about the best ways to measure and manage residual risk from air pollution after maximum control technologies are put in place," Charnley said. "Our final mandate, though, was much broader than that. Congress requested that the Commission examine risk assessment and risk management across the board in regulatory decision making, in addition to specifically addressing the questions about residual risks."

Specifically, the Clean Air Act Amendments of 1990 mandate that the Commission "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."

Risk management framework

The Commission's proposed framework for risk management comprises six stages that "can address various contaminants, media, and sources of exposure, as well as public values, perceptions, and ethics."

"Twenty years after the implementation of many of our country's major environmental and health laws, it is time to modify our current strategy of managing risks medium by medium, pollutant by pollutant," said Commission member Peter Chiu. "We all know that the real world doesn't work that way--problems are interconnected. If you eliminate solid waste by burning it, you've only eliminated one problem by creating another in the form of air pollution."

The experience of Chiu, a physician at the Kaiser Permanente Medical Group in Milpitas, California, and a former environmental engineer, includes assisting with the ground-breaking environmental management program for the San Francisco Bay area in the 1970s. The comprehensive program looked at water, air, and solid waste issues together rather than individually and relied extensively on stakeholder input. The Commission in part drew upon the experiences of this program in drafting its risk management framework.

Stakeholder involvement emphasized

A cornerstone of the Commission's risk management framework is the involvement of stakeholders during each stage of the process.

Earlier this month, another just-released report, the National Academy of Sciences' report on risk characterization titled Understanding Risk: Informing Decisions in a Democratic Society, further validated the Commission's emphasis on stakeholder involvement in risk management, said Commission member Bernard Goldstein, who is director of the Environmental and Occupational Health Sciences Institute in Piscataway, New Jersey.

"We were very pleased to see recommendations on stakeholder involvement in the National Academy of Sciences' report on risk characterization," Goldstein said. "The NAS commission and our commission worked independently of each other, but there is no question that there is a congruence of thought processes that it is critical to have stakeholders involved, which in the case of risk assessment and management means to get the community involved."

Controversial recommendations

Several of the Commission's recommendations are expected to be controversial, including those that support the use of a margin-of-exposure approach for carcinogens with linear dose-response characteristics; those that call for more qualitative descriptions and fewer quantitative descriptions of uncertainty in risk assessments; and those that call for some rodent tumor responses to be classified as irrelevant to human cancer risk assessments.

Margin-of-exposure approach. To allow risks to be more easily compared, the Commission recommends a margin-of-exposure approach to characterizing risks for carcinogens with both linear and non-linear dose-response characteristics.

"To aid in risk communication and to help risk managers decide how to use their limited resources, we're suggesting that a margin-of-exposure approach be used in addition to existing methods to characterize cancer risks for carcinogens with both linear and non-linear characteristics," Charnley said.

The recommendation is controversial within the U.S. Environmental Protection Agency, which currently uses the margin-of-exposure approach with noncarcinogens and has proposed its use with carcinogens with nonlinear dose-response characteristics but does not support its use with carcinogens that have linear dose-response characteristics at low doses.

Qualitative vs. quantitative descriptions of uncertainty. The Commission recommends that more qualitative descriptions be given of the uncertainties associated with risk assessments.

"We want to bring the focus away from quantitative descriptions of risk, which are useful but aren't the only story. The public and risk managers will be better informed by more qualitative descriptions of risks, such as what are the possible effects, under what conditions of exposure might those effects occur, what types of people might they affect, and so forth," Charnley said.

Consistent with this view, the Commission recommends that formal, quantitative analyses of the uncertainties in risk estimates not be required for most risk assessments. Because there have been many calls for requiring routine uncertainty analysis, the Commission felt the need to address the issue.

"Where we have major issues of transcendental federal importance that affect millions of jobs and billions of dollars, of course we need formal uncertainty analysis," Goldstein said. "But we are cognizant that most risk assessments are not done in the Beltway. Most are done at the state or local level, and most risk assessments done at the state and local levels are straightforward and don't need uncertainty analysis. State and local governments would be paralyzed if routine uncertainty analysis was required for each risk assessment."

Rodent cancer responses. The Commission proposes that when a chemical is found to produce rodent tumors only as the result of mechanisms or doses that are not relevant to humans, then those rodent cancer responses should be classified as irrelevant to human cancer risk assessment.

"We are simply saying that at this relatively late date we should codify the understanding we've come to with mechanistic studies," Goldstein said. "We now have good mechanistic information on the irrelevancy of certain rat and mice tumors to humans, so we should disregard them and move on."

Reviewers' comments sought

Since beginning work in May 1994, the Commission has held meetings around the nation, hearing testimony from federal, state, local, and individual witnesses.

"We heard from representatives from many diverse groups, from the mayor of Columbus, Ohio, to the NAACP, which is concerned about environmental justice issues, to industry groups to environmentalists," Goldstein said. Democrat and Republican staff members from Congress also presented testimony to the Commission.

With the release of its draft report, the Commission is seeking further written comments through August 9. Written comments should be sent to the Commission at 529 14th St. NW, Suite 452, Washington, D.C. 20045.

Copies of the draft report may be obtained by writing to the Commission or by faxing a request to (202) 233-9540. The final report is due in October 1996, after which the Commission will conclude its work with a follow-up period through September 1997.

"During this period, we are hoping to receive funding that will allow us to sit down with the organizations that our report is directed toward and talk with them about how the report's recommendations could be implemented," Charnley said.

Story posted June 13, 1996

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