Herb Estreicher Quoted in Inside TSCA Article on Biotech Innovation Under TSCA

Keller and Heckman Partner Herb Estreicher was quoted in the Inside TSCA article, “EPA, Agencies To Consider Biotech Innovation Under TSCA, Other Laws.” The article discusses President Biden’s Executive Order, issued on September 12, which directs the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA) to review how and under what circumstances each regulates biotechnologies, including under the Toxic Substances Control Act (TSCA). This order follows an EPA-specific effort by the new-chemicals office to ease its biofuels reviews, but some industry attorneys, including Herb, have urged EPA to revisit a long-standing argument that the agency is reading TSCA’s exception for “natural” substances too narrowly. “Notwithstanding EPA’s best efforts, its willingness to streamline [the PMN review process], I suspect that it will still be the case that many biofuels will be considered new chemicals and will have to go through the PMN process, probably unnecessarily so, and that many of them will be regulated,” said Herb. Instead of expanding its biofuels streamlining initiative, Herb argues that EPA should consider exempting more fuels derived from plant and animal matter from pre-manufacture notice (PMN) requirements altogether as “natural products.” While the agency allows some “natural” substances to avoid PMN review, Herb commented, that exemption is “extremely narrow. Basically, something extracted from nature can only be minimally processed to qualify for that exemption, that’s somewhat of a big surprise for people in the biofuels industry.”

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