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Improving Risk Analysis Approaches Used By the U.S. EPA

Completed

An NRC committee will develop scientific and technical recommendations for improving the risk analysis approaches used by the U.S. Environmental Protection Agency (EPA). Taking into consideration past evaluations and ongoing studies by the NRC and others, the committee will conduct a scientific and technical review of EPA's current risk analysis concepts and practices. The committee will consider analyses applied to contaminants in all environmental media (water, air, food, soil) and all routes of exposure (ingestion, inhalation, and dermal absorption).

Description

An NRC committee will develop scientific and technical recommendations for improving the risk analysis approaches used by the U.S. Environmental Protection Agency (EPA). Taking into consideration past evaluations and ongoing studies by the NRC and others, the committee will conduct a scientific and technical review of EPA's current risk analysis concepts and practices. The committee will consider analyses applied to contaminants in all environmental media (water, air, food, soil) and all routes of exposure (ingestion, inhalation, and dermal absorption). The committee will focus primarily on human health risk analysis and will comment on the broad implications of its findings and recommendations to ecological risk analysis. In making recommendations, the committee will indicate practical improvements that can be made in the near term (2-5 years) and improvements that would be made over a longer term (10-20 years). The committee will address topics such as the following:- Increased role for probabilistic analysis in risk analysis, including the potential expanded role for expert elicitation- Scientific bases for and alternatives to default assumption choices made in areas of uncertainty- Quantitative characterization of uncertainty resulting from all steps in the risk analysis- Approaches for assessing cumulative risk resulting from multiple exposures to contaminant mixtures, involving multiple sources, pathways, routes - Variability in receptor populations, especially sensitive subpopulations and critical life stages- Biologically relevant modes of action for estimating dose-response relationships, and quantitative implications of different modes- Improvements in environmental transport and fate models, exposure models, physiologically based pharmacokinetic (PBPK) models, and dose-response models- How the concepts and practices of ecological risk analysis can help inform and improve the concepts and practices of human health risk analysis, and vice versa- Scientific basis for derivation of uncertainty factors- Use of value-of-information analyses and other techniques to identify priorities and approaches for research to obtain relevant data to increase the utility of risk analysesThe project sponsor is the U.S. Environmental Protection Agency.The approximate starting date for the project is 8/29/2006.A report will be issued at the end of the project in approximately 24 months from the starting date.

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Conflict of Interest Disclosure



Disclosure of Conflict of Interest: Joseph V. Rodricks

In accordance with Section 15 of the Federal Advisory Committee Act, the "Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable." A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.

We have concluded that for the committee to accomplish the tasks for which it was established its membership must include among others, at least one person who is currently involved in practical applications of risk assessment concepts in addressing environmental, health, and safety issues and who can contribute to the committeeโ€™s understanding of how EPAโ€™s approaches to risk analysis have evolved over time and affect the efficiency and quality of the work being done by practitioners.

To meet the need for this expertise and experience, Dr. Joseph Rodricks is proposed for appointment to the committee even though we have concluded that he has a conflict of interest because he is a principal of ENVIRON International, a consulting firm that performs risk assessments for current clients whose financial interests could be affected by the outcome of the committeeโ€™s report.

As stated in his biographical summary, Dr. Rodricks is an internationally recognized expert on practical applications of risk assessment. He was a member of two previous NRC committees that prepared reports directly related and antecedent to the new study: Risk Assessment in the Federal Government: Managing the Process (1983) and Science and Judgment in Risk Assessment (1994). His first hand knowledge of the results of the two earlier studies and his familiarity with the practical aspects of risk assessment and the implications of implementing the report recommendations is critical for the committee in meeting its task. We believe that Dr. Rodricks can serve effectively as a member of the committee, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work.

After an extensive search, we have been unable to find another individual with the equivalent combination of current practical experience and expertise as Dr. Rodricks who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.

Committee Membership Roster Comments

Effective January 2007, the committee membership changed with the resignation of Dr. Melvin E. Andersen.

Effective September 2007, the committee membership changed with the resignation of Dr. Roger M. Cooke.

Effective January 2008, the committee membership changed with the resignation of Dr. Dorothy E. Patton.

Sponsors

EPA

Staff

Eileen Abt

Lead

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