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The pursuit of quality in risk assessment

The Toxicology Forum is an international organization that encourages dialogue among government agencies, industry, academia, policymakers, and NGOs concerned with public health issues. Following Congress’s recent passage of the Lautenberg Chemical Safety Act, the Toxicology Forum’s summer meeting in Salt Lake City, featured a particularly interesting and timely session on “the pursuit of quality and objectivity in risk assessment.”

The session began with a presentation by noted social scientist Dr. Stuart Shapiro, from the Rutgers University Bloustein School of Planning and Public Policy. Dr. Shapiro discussed how a law enables a governmental agency to act (i.e. its authority), but leaves the interpretation of how to comply with the law to the agency. This allows the agency to use its discretion and flexibility to implement the law and it is here where the intersection of science and policy becomes particularly important.

For instance, the new Lautenberg Chemical Safety Act (LCSA) suggests the need for regulatory action when there is an “unreasonable risk.” However, what constitutes unreasonable risk is not fully articulated in the LCSA. The science policy determination, as outlined in the new law, will be left to the U.S. Environmental Protection Agency (EPA) in their implementation of the statute.

To add to the conversation, Dr. Shapiro’s slides provided examples of federal programs at the intersection of science and policy that work well (e.g., EPA’s pesticides program) and programs that don’t work quite as well (e.g., EPA’s IRIS program). Dr. Shapiro also discussed his interesting research findings that politics, law and bureaucracy put bounds on the influence of science but that within those bounds good science can make a real difference. A particular challenge for scientists is communicating about uncertainty to officials who want clear answers.

Dr. Tom Sinks, the Director of the EPA Office of the Science Advisor, then gave a great overview of the role of the Office of the Science Advisor and provided examples of quality indicators in risk assessments. His slide presentation focused on examples of how even limited data can be very useful for important policy determinations. Dr. Sinks provided a candid example of how directed assessments, conducted to justify a predetermined decision, lack scientific integrity and utility.

Dr. Sinks also provided a contrarian approach to evaluating some of the elements commonly considered to be key indicators of quality. This was a great introduction to the talk from Dr. Penelope Fenner-Crisp, an independent consultant and former EPA senior official, who provided an overview of her recent EHP publication. She described the key elements that could be used by risk assessors, peer reviewers, decision-makers, and other stakeholders to evaluate the quality of a risk assessment. As summarized in her presentation, the key elements can be used as a resource not only to evaluate risk assessments, but also as a performance standard when conducting a risk evaluation.

Dr. Dima Shamoun, Associate Director of Research at the Center for Politics and Governance at the University of Texas at Austin, provided another social scientist perspective. Dr. Shamoun’s presentation discussed the need for process objectivity in risk assessment when we often don’t know the “truth.” Dr. Shamoun also discussed the need to address concerns related to bias.

Other speakers in the session provided diverse perspectives on quality at different types of agencies and organizations:

  • Antonia Mattia, a division director at the Center for Food Safety and Nutrition at the U.S. Food and Drug Administration (FDA), described how FDA ensures quality of regulatory risk assessments through stakeholder outreach, peer review and the reliance on high quality data and information that is thorough, unbiased and transparently presented.
  • Steven Packham, a toxicologist at the Utah Department of Environmental Quality, explained in his presentation how a state agency relies heavily on listening to residents in affected communities to ensure needs and quality of life standards are met. He also discussed the importance of personal risk assessment and described how a mobile tool can be used to inform individuals about air quality concerns taking personal considerations into concern in real time.
  • R. Jeffrey Lewis, from Exxon Mobil Biomedical Sciences, provided an industry perspective in his presentation and described the new scientific standards required under the new Lautenberg Chemical Safety Act that will need to be followed by EPA and stakeholders in conducting risk evaluations.

The diversity of presentations led to a robust discussion about how to handle uncertainty in risk assessment and how to explain uncertainty to the public. Ensuring robust peer review and having a plan to communicate findings clearly and transparently to the general public were described as highly important elements of the risk assessment process. The mix of toxicologists and social scientists, all playing in the same science-policy sandbox, made for a discussion that American Chemistry Council (ACC) hopes will continue.

Risk evaluation and risk management issues cut across many sectors and the depth and breadth of expertise, as was found on this panel, and the dialogue that comes from putting all these experts in the same space will surely help to ensure that new regulations, like those in the LCSA, are informed by appropriately diverse and informed perspectives.

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