SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is ( printed page 76489) not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

If you have any questions regarding the applicability of this action to a particular entity, consult either person listed under FOR FURTHER INFORMATION CONTACT .

B. What is the Agency's authority for taking this action?

This action is issued under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136-136y.

C. What action is the Agency taking?

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

• 2-Chloro-1,1,1,2-tetrafluoroethane (CAS Reg. No. 2837-89-0).
• α-(Cyclohexylmethyl)-ω-hydropoly(difluoromethylene) (CAS Reg. No. 65530-85-0).
• Dichlorotetrafluoroethane (CAS Reg. No. 1320-37-2).
• Ethane, 1,1,1,2,2-pentafluoro- (CAS Reg. No. 354-33-6).
• Hexafluoropropene, polymer with tetrafluoroethylene (CAS Reg. No. 25067-11-2).
• Montmorillonite-type clay treated with polytetrafluoroethylene (No CAS Reg. No.).
• Poly(difluoromethylene), α-chloro-ω-(1-chloro-1-fluoroethyl) (CAS Reg. No. 131324-06-6).
• Poly(difluoromethylene), α-chloro-ω-(2,2-dichloro-1,1,2-trifluoroethyl)-(CAS Reg. No. 79070-11-4).
• Poly(difluoromethylene), α-(2,2-dichloro-2-fluoroethyl)-, ω-hydro- (CAS No. 163440-89-9).
• Poly(difluoromethylene), α-fluoro-ω-[2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl]- (CAS Reg. No. 65530-66-7).
• Poly(oxy-1,2-ethanediyl), α-hydro-ω-hydroxy-, ether with α-fluoro-ω-(2-hydroxyethyl) poly(difluoromethylene) (1:1) (CAS Reg. No. 65545-80-4).
• Propane, 1,1,1,2,3,3,3-heptafluoro- (CAS Reg. No. 431-89-0).

None of these twelve chemicals are currently being used as an inert ingredient in a pesticide product per EPA records of currently registered pesticide products. Additionally, no products containing any of these 12 chemicals were identified during the public comment period. EPA 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 ( https://www.epa.gov/​system/​files/​documents/​2021-10/​pfas-roadmap_​final-508.pdf).

Once an inert ingredient is removed from the list, any proposed future use of the inert ingredient would need to be supported by data provided to and reviewed by the EPA as part of a new inert ingredient submission request. The type of data needed to evaluate a new inert ingredient may include, among others, studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, genotoxicity as well as environmental effects associated with any chemical substance that is persistent or bioaccumulative. Information regarding the inert ingredient approval process may be found at https://www.epa.gov/​pesticide-registration/​inert-ingredients-overview-and-guidance.

D. How can I access the docket for this action?

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2022-0542, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room and the OPP docket is (202) 566-1744. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/​dockets.

II. Background

A. What are inert ingredients?

Most pesticide products contain substances in addition to the active ingredient(s) that are referred to as inert ingredients or sometimes as “other ingredients.” An inert ingredient generally is any substance (or group of similar substances) other than an active ingredient that is intentionally included in a pesticide product. Examples of inert ingredients include emulsifiers, solvents, carriers, aerosol propellants, fragrances, and dyes. Additional information about inert ingredients, including requirements, and guidance can be accessed at https://www.epa.gov/​pesticide-registration/​inert-ingredients-regulation. The InertFinder tool, which contains the list of currently approved inert ingredients, can be found at https://ordspub.epa.gov/​ords/​pesticides/​f?​p=​INERTFINDER:1::::1::.

B. What did EPA propose?

On September 13, 2022 (87 FR 56051; FRL-9985-01-OCSPP), EPA published for comment a proposal to remove 12 chemicals from the Agency's list of inert ingredients approved for use in pesticide products because they have been identified as PFAS and they are no longer used in pesticide products. 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 the Agency.

C. What comments did EPA receive and what is EPA's response?

EPA received six public comments on the proposal. A summary of the comments and EPA's responses is presented in this unit.

1. Support for removal of PFAS inert ingredients: Five commenters expressed support for the removal of the 12 PFAS inert ingredients. However, some commenters also expressed concern for other remaining PFAS inert and active ingredients in pesticide products apart from the 12 chemicals being removed. EPA will continue to look closely at existing pesticide products to determine whether they contain PFAS. As the Agency's understanding of PFAS grows and evolves, EPA will continue to follow the science and adjust, as appropriate, to help ensure that pesticide formulations do not cause unreasonable adverse effects on human health or the environment. EPA will also consider various regulatory options to address any concerns identified.

2. Administrative decision to remove chemical substances: One commenter stated that FIFRA requires that the Agency decision to remove chemical substances from the approved inert ingredient list must be based on risk. FIFRA does not state a standard for approval of an inert ingredient, specifying only the fee category and review time. While the statute incorporates the risk of unreasonable adverse effects on the environment as one of the factors in granting a registration for an individual pesticide product under FIFRA section 3, no such criteria apply to approval of an inert ingredient. Addition of an inert ( printed page 76490) ingredient to the approved inert list is a prerequisite to approval of applications for registration of specific pesticide formulations that contain the inert ingredient. Approval of a registration application does incorporate risk and considers risks resulting from the formulation of the pesticide product including its inert ingredients.

As of the date of this notice, EPA is removing the twelve chemicals listed here from the current list of inert ingredients approved for use in pesticide products. These twelve chemicals are for nonfood use only and there are no food residue considerations related to this action.

Authority:7 U.S.C. 136 et seq.