TABLE C-1 Timeline of Selected EPA Risk-Assessment Activities

Date and Title of Milestone

Commentsa

EPA 1976 Interim Procedures and Guidelines for Health Risk and Economic Impact Assessments of Suspected Carcinogens

First agency “inference” guidelines on cancer risk. “How likely is the risk to occur, and if it does occur, what are the consequences? How likely is an agent to be a human carcinogen? How much cancer might be produced by the agent if it remains unregulated?”

NRC 1983 Risk Assessment in the Federal Government: Managing the Process

Seminal risk-assessment report that established the four organizing principles for government risk efforts: hazard identification, dose-response assessment, exposure assessment, and risk characterization. Report also recommended that uniform inference guidelines be developed and that regulatory agencies take steps to establish and maintain a clear distinction between risk-assessment and risk-management activities.

 

Definition of Risk Assessment: characterization of potential adverse health effects of human exposure to environmental hazards.

EPA 1984 Risk Assessment and Management: Framework for Decision Making

EPA’s response to NRC (1983), Risk Assessment in the Federal Government: Managing the Process. Discusses EPA’s activities to address recommendations in the 1983 NRC report, including establishing the Risk Assessment Forum and efforts to develop six risk-assessment guidelines. Risk-management activities were expanded to include cost-effectiveness tools that could be used in risk management, the importance of strengthening communication in risk management, and risk-management principles, such as consistency of approach in making decisions. Prompted training program for EPA senior managers with emphasis on the distinction between risk-assessment and risk-management activities.

 

Definition of Risk Assessment: In simplest sense, population risks posed by toxic pollutants are a function of two measurable factors: hazard and exposure. To cause a risk, a chemical has to be both toxic (present as intrinsic hazard) and present in the human environment at some substantial level (provide opportunity for human exposure). Risk assessment interprets evidence on the two points, judging whether an adverse effect will occur and (if appropriate) making the necessary calculations to estimate the extent of total effects.

1984 Risk Assessment Forum Charter

In 1984, the Risk Assessment Forum (RAF) is established in response to an NRC (1983) recommendation “to promote consensus on risk assessment issues.” RAF convenes risk-assessment experts to study and report on risk-assessment issues. RAF has produced risk-assessment guidelines, technical panel reports on special risk-assessment issues, and peer-consultation and peer-review workshops (EPA 2002a).

OSTP 1985 Chemical Carcinogens: Review of the Science and Its Associated Principles

Report details 31 principles developed by interagency group for carcinogenicity evaluations in regulatory settings.

EPA 1986a Memorandum: Establishment of the Risk Assessment Council

The Risk Assessment Council is established in 1986 by Lee Thomas to “oversee virtually all aspects of the Agency’s risk assessment process, to identify issues and problems with that process” (EPA 1986a), and to ensure that EPA programs use risk assessment in a consistent and scientifically credible fashion.



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