On December 14, 2022, the U.S. Environmental Protection Agency (EPA) announced the removal of 12 chemicals from the current list of non-food inert ingredients approved for use in pesticide products because the inert ingredients have been identified as per- and polyfluoroalkyl substances (PFAS) and are no longer used in any registered pesticide product. 87 Fed. Reg. 76488. On September 13, 2022, EPA published a proposal to remove the 12 chemicals from the list of approved inert ingredients. In response to EPA’s request for comments, no specific information regarding those 12 chemical substances or any products that may include them was provided to EPA.

EPA is removing the following 12 chemicals from the current list of inert ingredients approved for use in pesticide products:

• 2-Chloro-1,1,1,2-tetrafluoroethane (Chemical Abstracts Service Registry Number® (CAS RN®) 2837-89-0);

• α-(Cyclohexylmethyl)-ω-hydropoly(difluoromethylene) (CAS RN 65530-85-0);

• Dichlorotetrafluoroethane (CAS N 1320-37-2);

• Ethane, 1,1,1,2,2-pentafluoro- (CAS RN 354-33-6);

• Hexafluoropropene, polymer with tetrafluoroethylene (CAS RN 25067-11-2);

• Montmorillonite-type clay treated with polytetrafluoroethylene (no CAS RN);

• Poly(difluoromethylene), α-chloro-ω-(1-chloro-1-fluoroethyl) (CAS RN 131324-06-6);

• Poly(difluoromethylene), α-chloro-ω-(2,2-dichloro-1,1,2-trifluoroethyl)- (CAS RN 79070-11-4);

• Poly(difluoromethylene), α-(2,2-dichloro-2-fluoroethyl)-, ω-hydro- (CAS RN 163440-89-9);

• Poly(difluoromethylene), α-fluoro-ω-[2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl]- (CAS RN 65530-66-7);

• Poly(oxy-1,2-ethanediyl), α-hydro-ω-hydroxy-, ether with α-fluoro-ω-(2-hydroxyethyl)poly(difluoromethylene) (1:1) (CAS RN 65545-80-4); and

• Propane, 1,1,1,2,3,3,3-heptafluoro- (CAS RN 431-89-0).

EPA states, in the PFAS Strategic Roadmap to address PFAS, it is removing these chemicals from the inert ingredient list to prevent the introduction of these PFAS into pesticide formulations without additional EPA review. This is in line with EPA’s strategic roadmap to address PFAS.

According to EPA, once an inert ingredient is removed from the list, any proposed future use of the inert ingredient would need to be supported by data, which may include studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, and genotoxicity, as well as data on environmental effects. The data must be provided to and reviewed by EPA as part of a new inert ingredient submission request.

The final notice and information on inert ingredients approved for use in pesticide products is available here.

Additional information on EPA’s action on PFAS in pesticide containers is available here.

Commentary

EPA’s final removal of these ingredients from the current list of approved inert ingredients list is not surprising, although it raises important process questions that should be watched closely in future EPA Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) actions. The removal action helps EPA meet its political commitment related to PFAS consistent with the PFAS Roadmap, and as EPA states itself, the 12 PFAS that are the subject of the notice are no longer used in any registered pesticide products. Predictably, public comments focused on general risks of PFAS and not directly on EPA’s action related to inert ingredients listing removal. It is a win for EPA related to its commitment to take action to limit PFAS.

The process EPA used to remove these 12 chemicals from the list of inert ingredients is noteworthy and potentially concerning. EPA presented no risk-based evidence for this regulatory action and instead relied on a class-based aggregation of a subset of approved inert ingredients. It will be important to continue to monitor this issue.