Charles M. Auer Quoted In “Chemical Risk Review Details Expected From EPA by Fall”
On August 3, 2017, Charles M. Auer, Senior Regulatory and Policy Advisor with Bergeson & Campbell, P.C. (B&C®), was quoted by Bloomberg BNA Daily Environment Report discussing U.S. Environmental Protection Agency (EPA) plans to release documents detailing its new Toxic Substances Control Act (TSCA) chemical review process.
The documents are expected to aid companies as they prepare premanufacture notices (PMNs) they must submit when asking the agency to approve a new chemical, Charlie Auer, senior regulatory and policy adviser with Bergeson & Campbell, said. As a result, companies may be able to bring their products to market sooner.
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Auer said it would be helpful if the EPA also updated the Chemical Categories Document it uses. The document groups together chemicals that—based on their solubility, volatility, or other properties—act in similar ways in the environment or in people’s bodies. The agency lists concerns it may have about each chemical category and toxicity data that could help it address those concerns. The EPA published its most recent Chemical Categories Document in 2010.
“Times have changed,” said Auer, who worked at the EPA for more than 30 years, including as a former OPPT director. Much of the information that’s in the 2010 document is actually decades old, he said.
The EPA could update its chemical categories with new information it has gathered over the years and describe new types of toxicity and exposure tests companies could conduct that would provide valuable information, he said.
Bergeson & Campbell recently released comments on four new chemical categories the agency has shared with companies submitting the premanufacture notices and mentioned at public meetings. The agency’s categories focus on potential respiratory problems that workers or other exposed people might experience if they inhaled chemicals with certain structures or chemicals that perturb lung cells in certain ways.
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The documents the EPA plans to release by September combined with updated categories could help companies understand what they need to give the agency to get their chemicals to market sooner, Auer said.
But, the EPA needs to commit to finishing its new chemical reviews faster, he said. The agency has made significant progress since TSCA was amended in 2016 to make decisions concerning a backlog of new chemical requests that had built up immediately following passage of the new law, he said.
But once the EPA makes its decision, it’s taking too long for companies to negotiate the types of controls that could be required for new chemicals, Auer said.
The agency should consider developing a clear process to address “adversarial” determinations when it and a manufacturer cannot agree on whether some type of control is needed, he said.
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