Lynn L. Bergeson and Richard E. Engler, Ph.D., Quoted by Inside TSCA in “Industry Sees NAMs Aiding New Chemical Reviews, But Laments PPE Delays”
On February 15, 2022, Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and Richard E. Engler, Ph.D., Director of Chemistry, B&C, were quoted by Inside TSCA regarding the U.S. Environmental Protection Agency’s (EPA) application of new approach methods (NAMs) and category-based analyses for new-chemical reviews.
An industry attorney says EPA’s application of new approach methods (NAMs) and category-based analyses for new-chemical reviews is helping some substances move through the TSCA process quickly and in a “predictable” way, even as she says some applications still face delays, in part from new policies on personal protective equipment (PPE).
Lynn Bergeson, managing partner of the law firm Bergeson & Campbell, raised those dueling appraisals of the Biden EPA’s Toxic Substances Control Act (TSCA) implementation in a Feb. 11 session of the virtual Environmental Law 2022 conference sponsored by American Law Institute Continuing Legal Education and Environmental Law Institute.
EPA’s toxics and research offices “are to be congratulated for working very hard for several years in making that space more predictable and amenable to legitimate and reasonable regulatory approaches.”
But despite those advances, she said the timeframe for new chemicals reviews remains “anywhere from 180 days to longer, much to the consternation of clients wishing to commercialize new chemicals, particularly those thought to be more sustainable, less toxic and more effective than the incumbent chemicals they are trying to replace.”
She named as a major factor in those delays EPA’s 2021 decision to drop its Trump-era policy where TSCA risk assessments would assume workers wear PPE when a chemical is produced or used. While EPA has insisted that shift will not automatically result in more stringent risk findings, Bergeson said it “has had a very significant impact” on reviews of new chemicals.
“A lot of them are getting tripped up and . . . subject to additional regulation because of that reversal in the assumption that PPE is not used and [it is] causing some problems and diminishing the number of chemicals that are ultimately being commercialized because of the imposition of lot of restrictions on them,” she said.
Asked after the conference how important the PPE policy change has been in comparison to other factors, Bergeson said, “EPA’s reversal on the PPE is one of many factors contributing to slowing the commercialization of new chemical innovations. Others include reliance on modeled as opposed to actual data, delayed review times, errors in scientific review, application of unreasonable risk assumptions, among others.”
Richard Engler, Bergeson & Campbell’s director of chemistry and a former Office of Pollution Prevention and Toxics (OPPT) staffer, tells Inside TSCA that EPA’s development of more inhalation categories and adoption of NAMs has aided that process.
The agency has “developed several inhalation categories and in vitro methods [or NAMs] to inform potential concerns without in vivo testing” of live animals, he says. As examples, Engler points to inhalation categories EPA has begun using for certain surfactants and respiratory sensitizers.
“EPA has further refined these categories to better characterize the potential hazards, including NAM approaches to help define the boundaries of whether a substance is within the category,” he says.
See – https://insideepa.com/tsca-news/industry-sees-nams-aiding-new-chemical-reviews-laments-ppe-delays (subscription required)