Results of University Survey Point to Ways Regulatory Chemical Analyses Could Improve

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By Pat Rizzuto

Dec. 6 --Agencies could improve their chemical risk assessments in ways such as conducting more preparatory analyses before they start their assessments, government, private sector and academic risk experts said in a report published Dec. 6 by the George Mason University.

The report summarizes results from an industry-funded survey of toxicologists and other scientists involved in risk assessment.

The results show a gap between what toxicologists and other scientists think should be done in regulatory chemical assessments and the risk assessments that government agencies actually conduct, said S. Robert Lichter, who directs George Mason University's Center for Media and Public Affairs. That center and the university's Center for Health and Risk Communication prepared the survey with the assistance of Harris Interactive, a survey and market research firm.

Lichter summarized the survey results in a report called Expert Opinion on Regulatory Risk Assessment.

He presented his findings in an online forum held by the International Society for Regulatory Toxicology and Pharmacology.

The American Chemistry Council, Crop Life America and the International Platinum Group Metals Association funded the survey.

Three Professional Societies

The Society of Toxicology (SOT), which has more than 7,000 members, the Society for Risk Analysis (SRA), for which membership numbers could not be immediately obtained, and the International Society for Regulatory Toxicology and Pharmacology, which has fewer than 100 members, agreed to ask some or all of their members to participate in the survey.

SOT chose to send the survey request to its Risk Assessment Specialty Section; SRA chose to send the survey to its Dose Response Section; and the international society chose to send the survey to all of its members, Lichter said.

SOT and SRA thought the portion of their membership they selected were most likely to be involved in chemical risk assessments, he said.

A total of 970 members of the three professional societies were asked to participate, and 186 people responded to the survey, Lichter told Bloomberg BNA.

No Differentiation

Respondents were not asked about levels of government assessments--municipal, county, state, or federal--on which they worked.

Nor were respondents asked about the agencies conducting the chemical assessments. At the federal level, the Food and Drug Administration and various offices within the Environmental Protection Agency conduct regulatory risk assessments of chemicals. Some states, such as California and Minnesota, also have that capacity.

The preparatory stage of a risk assessment is called the problem formulation stage.

Lichter said 68 percent of respondents said the problem formulation stage is very important.

Yet such preparatory analyses occurred “always” or “often” in only 30 percent of the chemical risk assessments with which the toxicologists and other risk experts had experience.

Lichter's survey involved questions about topics including:

• the use of criteria to select and evaluate scientific data;

• the frequency that mode of action information (data that help explain how a chemical causes biological effects) is used;

• the extent to which government agencies follow their own guidance documents; and

• the weight risk assessors should give factors such as economic costs and benefits and media coverage of an issue.

Concerns Unclear

George Gray, president of the Society of Risk Analysis, was among the speakers invited to comment on the survey results. Gray, who directs the George Washington University Center for Risk Science and Public Health, served as EPA's assistant administrator for research and development from 2005 to 2009 under President George W. Bush.

The results of the survey do not show whether the risk experts thought agencies need to improve the process by which they conduct chemical risk assessments or the content of such assessments, Gray said.

But they identify characteristics of assessments that risk experts value, Lichter said.

The results could spur discussions among professional risk assessors about ways to improve their work, he said.

The results are timely, Gray said, because at least one program within one federal agency is in the midst of working to improve its assessments. He referred to the Environmental Protection Agency's Integrated Risk Information System (IRIS).

To contact the reporter on this story: Pat Rizzuto in Washington

To contact the editor responsible for this story: Larry Pearl at

Expert Opinion on Regulatory Risk Assessment and presentations made during the Dec. 6 online forum are available at the international society's website, where an audio of the presentations also will be posted:

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