Commission on Risk Assessment

and Risk Management

FOR IMMEDIATE RELEASE

EMBARGOED UNTIL MARCH 7,1997

CONTACT: Sharon Newsome (202) 233-9533

Presidential/Congressional Commission Issues 71 Recommendations

To Improve EPA, FDA, Other Federal Agency Approaches to

Environment, Public Health Threats

WASHINGTON - Government agencies need to change how they approve new medications, decide on clean up of Superfund sites, analyze laboratory animal test results of poisons or cancer-causing substances, and weigh the costs and benefits of environmental protection, said the Presidential/Congressional Commission on Risk Assessment and Risk Management today as it issued 71 detailed recommendations for reforming how the federal government addresses threats to air, water, soil and public health.

In Volume II of its two-part report, the 10-member Commission says the current risk management procedures are often too simplistic or complex to be effective and relevant. The Commission instead recommends specific changes to key environmental and health policies that would equally weigh coordination among agencies, public participation, peer review and analysis. For example, the Commission recommends that the increasingly costly Superfund program should be based on site use and should review and change remedies that use expensive, outdated technology.

Dr. Gilbert S. Omenn, chairman of the Commission and dean of the University of Washington's School of Public Health and Community Medicine in Seattle, said the Commission found that one of the greatest risks to human health - indoor air pollution - is largely unregulated and needs immediate attention by Congress and the Administration.

"Indoor air pollution often poses a greater health risk than outdoor air pollution," said Dr. Omenn. "Unregulated use of pesticides, cleaning chemicals, deodorants, and emissions from gas and wood stoves generate high concentrations of potentially toxic indoor air pollutants."

To deal with the issue, the Commission recommends that Congress and the Administration craft legislation requiring EPA, OSHA, CPSC and other federal agencies to develop a coordinated strategy to address the growing problem of indoor air pollution.

Other agency-specific recommendations include:

Environmental Protection Agency (EPA)

• Superfund site cleanups should be based on "reasonably anticipated current and future use of a site." Congress "should encourage reuse of brownfields," those urban sites "where economic use is avoided because of liability concerns," and give the Environmental Protection Agency (EPA) "broader authority to develop enforceable institutional controls" to ensure land use doesn't change.
• The Clean Water Act should be amended to replace its "fragmented programs" with a comprehensive, integrated watershed-management approach to maintain and improve water quality.

Food and Drug Administration (FDA)

• To foster the federal Food and Drug Administration's accelerated review and approval of new drugs, the FDA ought to "update criteria for toxicity-testing and clinical-trial protocols" with its counterpart agencies in foreign countries "so that properly documented studies...in other countries can be used as evidence for FDA review." The FDA's accelerated approvals of new drugs "should be linked to rigorous post-marketing surveillance." In addition, the FDA should be given back the power to require scientific evidence of the health claims for dietary supplements.
• The "Delaney Clause," the federal law requiring a ban on food additives or chemical residues that might possibly cause cancer, should undergo "substantial modification ... to a standard of reasonable certainty of no harm for all population groups."

Department of Agriculture (USDA)

• USDA must replace its "rudimentary, conflicting..., inadequate" methods for assessing such microbiological risks to food as E. coli contamination of ground beef and other products.

Occupational Safety and Health Administration (OSHA)

• OSHA should establish guidelines for agency risk assessments and streamline the process for developing permissible exposure limits for air contaminants in the workplace. OSHA also should cooperate more with the National Institute for Occupational Safety and Health.

General recommendations include:

• Regulatory agencies should distinguish between chemical tests involving laboratory animals that develop cancerous tumors "only ... as a result of mechanisms or doses that ... clearly ... [are] not relevant to humans," and test results that "are predictive" of possible effects on humans. A chemical that causes effects that are not relevant to humans "should not be regulated as a carcinogen and should not require extensive risk assessment."
• Risk assessment should identify particular groups of susceptible people - those in specific occupations, residents of low socioeconomic areas - who are likely to have higher exposure to chemicals being assessed. The affected people should be consulted early in the assessment process for information on all known sources of exposure to that chemical and related chemicals.
• Congress should reject proposals to subject risk assessment and benefit-cost analysis "to expanded judicial review." Instead, court involvement should be minimized while "consensual" approaches - such as alternative dispute resolution techniques, negotiated rule-making and expert peer review - should be increased.
• Risk managers and those with a stake in their decisions should "aggressively seek alternatives to command-and-control regulation to improve the efficiency and effectiveness of health and environmental protection and to reduce compliance and litigation costs."

The Commission, established under 1990 amendments to the federal Clean Air Act, began its work in May, 1994. Its members, including experts in public health, law, science, the environment and industry, were appointed by the leaders of the House and Senate, the president and the National Academy of Sciences. Its report follows public hearings held across the country and testimony from the EPA, FDA, OSHA, DOE, state and local officials, and many individuals and organizations.

The Commission was assigned to review the procedures for devising and enforcing the regulations that protect humans and the environment from substances that degrade ecosystems or cause cancer and other chronic health effects - effects that result from cumulative, repeated exposures but may not appear for months, years or decades.

The first volume of the Commission's report deals with its recommendations for establishing a six-stage Risk Management Framework to define a problem and put it in context, analyze the risks associated with the problem, examine options for addressing the risks, make decisions about which options to implement, take actions to implement the options selected, and then conduct an evaluation of the results.

The Commission will remain active until June 1997 to assist Congress, the Administration and various other interested parties in considering its recommendations "and finding common ground with relevant proposals from others," the report says.

Congressionally authorized to investigate and make recommendations on the use of risk assessment

and risk management in Federal regulatory programs.

This reprint of this press release was posted in RiskWorld on March 14, 1997.