The American Chemistry Council (ACC) introduced a set of comprehensive principles for improving chemical hazard and risk assessment programs. The Principles are designed to provide obtainable, high-level benchmarks for fixing federal programs so they produce more scientifically sound and timely chemical assessments. The Principles highlight several key areas of the chemical assessment process that need to be improved to provide regulators, the public and industry with more accurate and useful information to help guide better decisions about managing chemicals.
“The consistent application of good science is the hallmark of an effective chemical assessment program,” said ACC president and CEO Cal Dooley. “These Principles can be used to strengthen the foundation for many of these federal programs and allow them to produce more timely and useful information for protecting human health and the environment.”
The release of these Principles is a culmination of ACC’s efforts to improve the quality of federal chemical risk and hazard assessments since the National Academy of Sciences (NAS) report on EPA’s flawed formaldehyde assessment three years ago. The Principles are consistent with the Obama Administration’s science integrity goals and Executive Order 13563, “Improving Regulation and Regulatory Review.” They are also in line with the results of a survey of toxicology experts conducted by George Mason University, which found widespread agreement on a need for the government to establish clearer policies and better methodology for chemical risk and hazard assessments.
ACC’s Principles, highlighting four areas for improvement, are the following:
1. Design: Before beginning an assessment, key issues should be identified upfront, and stakeholders must be engaged in problem formulation and scoping. Modern scientific policies and practices should be utilized instead of relying on outdated assumptions and default approaches.
2. Data and Methods: Assessors should develop and apply consistent criteria for evaluating data and for selecting studies used in assessments. All assessments must be based on a framework that takes into account—and integrates—all relevant studies, while giving the greatest weight to the most relevant and highest quality studies.
3. Communication: Transparency in the chemical review process must be increased by providing full disclosure of underlying data and key information used to develop the assessment. Both hazards and risks must be characterized accurately and in a manner that is relevant to actual human exposure.
4. Review and Accountability: To ensure the value and objectivity of assessments, all chemical assessments must be subject to robust review by independent experts and peer review panels. Additionally, accountability and transparency can be ensured by improving the process to fully address expert findings and public comments.
Looking ahead, there are a number of important chemical hazard and risk assessment activities that are expected to complement ACC’s recommendations for improved federal assessment programs. For example, the NAS is completing its reviews of the IRIS Program and the 12th RoC evaluations of formaldehyde and styrene.
“We believe our Principles along with the results of the pending NAS reviews will set the necessary benchmarks for ensuring these programs become a more useful decision-making tool for regulators,” said Dooley. “We are committed to working with the Administration and Congress to improve the process for conducting chemical assessments and establishing a world-class system for managing chemicals.
“Our commitment to addressing current challenges with chemical assessments and their overall utility extends beyond the Principles we’re releasing today,” Dooley added. “It also includes our ongoing investment under the Long-Range Research Initiative to conduct collaborative exposure research.
“This research is leading to a better understanding of everyday exposures to chemicals and helping prevent the over-reliance and premature use of hazard data for making decisions about chemicals,” Dooley concluded.
View the full Principles
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