Since the preparation of this chapter, risk analysis has become an increasingly visible and controversial topic in the United States. The discussion has centered on sweeping legislative reform proposed during the 104th Congress (1995-1996) and included suggested reforms in risk assessment, risk management, and risk communication. Omnibus risk/regulatory reform legislation, which in some cases would supersede existing law, has been proposed, as well as reforms of specific legislation, including the Safe Drinking Water Act, the Comprehensive Environmental Remediation and Cost Liability Act (Superfund), and the Federal Food, Drug & Cosmetic Act (FFDCA, and specifically the Delaney Clause). While none of these measures have been passed into law, the discussions are likely to be on-going for several years, but already have had impacts on agency approaches and policies.

Key issues identified from these complex discussions include risk- and cost-benefit analysis, risk characterization policy, peer review policy, priority setting policy for agencies, relationship between individual statutes and "supermandate" provisions which could supersede individual statutes; and provisions for judicial review of agency actions.

Some selected examples of how these issues translate into legislative language are illustrated by the following, which have appeared somewhat consistently in many of the proposed bills:

- risk assessments based on the most "scientifically objective and unbiased informa tion;"

- risk characterizations to state the "reasonable range of scientific uncertainties" and, in addition use the "best estimate" of risk, and the "plausible upper-bound or conservative estimates in conjunction with plausible lower bound estimate;"

- comparison of risks to establish priorities for allocation of resources for risk reduction activities;

- establishment of peer review programs that "shall not exclude peer reviewers with substantial and relevant expertise" because they represent entities "that may have a potential interest in the outcome" of the peer review, though full disclosure of such interests may be mandated;

- for major rules ($50-100 million), benefits of the rule must "justify" the costs; if the statutory basis for the rule prohibits the cost-benefits balancing, the "least net cost" option among reasonable alternatives must be adopted;

- judicial review of agency actions and compliance with the law;

This intense attention to risk reform by the 104th Congress follows the actions of the 103rd Congress which mandated, under the Federal Crop Insurance Reform and Department of Agriculture Reorganization Act of 1994, the creation of an Office of Risk Assessment and Cost Benefit Analysis. The office has responsibility to assess risks to human health and the environment and prepare cost-benefit analyses for proposed "major" regulations—those having an impact on the economy of $100 million of more.

It has also been suggested that the current debate over regulatory reform and risk assessment overlooks the public health perspective. Whereas much of what is in the regulatory arena is based on the premise of public health protection, the ongoing arguments over risk reform may not translate into public health protection. The Centers for Disease Control, which has major responsibility for public health protection and disease prevention, has been virtually absent from the discussions over risk reform legislation. To increase understanding and communication about risk analysis among diverse audiences, senior federal agency representatives drafted a set of principles for using risk analysis that could be adopted by agencies on an individual basis. The principles identify terms and briefly describe the elements that comprise risk assessment, risk management, risk communication, and priority setting using risk analysis.

Much of the pending environmental and regulatory reform legislation have requirements that have to be met by state health and environment departments, which lack the tools necessary for performing the proposed enhanced risk assessment and cost-benefit analyses. While states have the capacity for the present framework, some of the pending legislation would require significant and probably costly changes to current state procedures.

During 1995-1996, the President's Commission on Risk Assessment and Risk Management held hearings across the United States from a variety of experts and the public. The bipartisan commission was established under the Clean Air Act (CAA) Amendments of 1990, following an earlier period of intense debate over "residual risk," the risk levels remaining after the CAA technology-based standards have been implemented. The commission's report is expected during 1996 and would have jurisdiction and impact on all federal risk assessment and risk management policies, not just those associated with air emissions and contaminants.

Changes in the food safety and inspection practices have been or are being proposed at both the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA). The Department of Agriculture has proposed a "paradigm" shift in the way meat and poultry products are inspected. The USDA's Food Safety and Inspection Service is pursuing a strategy that over time will improve the safety of meat and poultry products and significantly reduce the risk of food-borne illness. The strategy relies upon the Hazard Analysis Critical Control Point (HACCP) inspection system, which focuses on prevention of infectious agent contamination and on mandating microbial testing to detect the presence of pathogens. A similar approach using HACCP has been proposed by the FDA to apply to seafood to increase the safety of the seafood supply.

More recently, the United States Environmental Protection Agency released in the Federal Register new Proposed Guidelines for Carcinogen Risk Assessment. These proposed guidelines update the 1986 guidelines and are intended to allow incorporation of the increasing knowledge of the mode of action of cancer formation and the uncertainties associated with not only whether a chemical causes cancer in humans, but how it might do so. Other EPA related activities at various stages of preparation include guidelines on Ecological Risk Assessment, Exposure Assessment, Non-cancer Risk Assessment, Benchmark Dose, and Endocrine Disruptors. While this approach to consideration of carcinogenicity mechanisms has received much attention in the United States during the last several years, it is already in use in various forms in Western European countries and in The Netherlands since 1978.

And finally, numerous scholarly studies have been released and published on topics touched on in this chapter, most notably by the National Research Council on carcinogens and anticarcinogens in the human diet and the means by which cancer risks associated with food intake and the diet are estimated. The diet in the United States contains both naturally occurring and synthetic substances that are known or suspected to affect cancer risk. It has been suggested from such studies that toxic chemicals that occur naturally in foods may pose a greater-though still small-risk of cancer than the residues of synthetic pesticides that people consume in their diets.

Thus, the risk paradigm in the United States is under vigorous scrutiny from the scientific community, the regulatory community, decision-makers, and the public. In response to this scrutiny, federal and state agencies with responsibility for protection of the public health and environment, and which use risk analysis as a tool to fulfill their responsibilities, have implemented major changes and reforms. The success of these reforms will require several years to be measured.

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