On October 10, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its final rule establishing exemptions for a tolerance limit to use tall oil fatty acids (TOFA) as an inert ingredient “[i]n pesticide formulations applied to growing crops and raw agricultural commodities after harvest; in pesticides applied in/on animals, and in antimicrobial formulations for food contact surfaces.” Pursuant to Section 408(c)(2)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA has the authority to establish exemptions from the requirement of a tolerance only when it can be demonstrated clearly that the risks from aggregate exposure to the pesticide residue, including all anticipated dietary exposures and all other exposures, particularly to infants and children, for which there is reliable information, will pose no appreciable risks to human health. In analyzing the risk, EPA considers both the toxicity of the inert ingredient and the reasonably foreseeable circumstances for exposure to the substance. Following its evaluation and consideration of the validity, completeness, and reliability of available toxicity data, EPA determined that sufficient data were available to conclude that TOFA do not have a toxic mechanism and will not pose a risk to the U.S. population.
EPA established the final rulemaking following a petition by Spring Trading Company on behalf of Ingevity Corporation requesting that 40 C.F.R. Sections 180.910, 180.930, and 180.940(a) be amended to establish the exemptions. The regulation is effective immediately and eliminates the need to establish maximum permissible levels for residues of TOFA that are consistent with the conditions of these exemptions. Objections and requests for hearings regarding the regulation are due by December 11, 2017.