2022-19008. Pesticides; Proposed Removal of PFAS Chemicals From Approved Inert Ingredient List for Pesticide Products

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is proposing to remove twelve chemicals from the current list of inert ingredients approved for use in pesticide products because these inert ingredients have been identified as per- and polyfluoroalkyl substances (PFAS) and they are no longer used in any registered pesticide product.

DATES:

Comments must be received on or before October 13, 2022.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2022-0542, through the Federal eRulemaking Portal at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting and visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

Marietta Echeverria, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

You may be potentially affected by this action if you engage in activities related to the registration of pesticide products, including but not limited to, the use of approved inert ingredients used in registered pesticide products. The following list of North American Industrial Classification System (NAICS) codes is 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:

• Entities engaging in the formulation and preparation of agricultural and household pest control chemicals or pesticide and other agricultural and household pest control chemicals or inert manufacturers and those who make proprietary inert ingredient formulations or pesticide and other agricultural chemical manufacturing generally (NAICS code 325320).

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 proposing to remove 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); and
• 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. EPA believes it is appropriate to remove these chemicals from the inert ingredient list in order to prevent the introduction of these PFAS into pesticide formulations without additional EPA review.

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-regulation.

EPA suggests that pesticide registrants review their records to ensure that the chemical substances, listed by chemical name and Chemical Abstracts Service Registry Number (CAS Reg. No.), listed in the docket for this action are, in fact, no longer used as inert ingredients in their registered pesticide products. While EPA has endeavored to prepare an accurate list, if a pesticide registrant is aware of a registered product containing any of the twelve chemical substances, that registrant should contact the Agency directly, using the contact listed under FOR FURTHER INFORMATION CONTACT .

Similarly, producers of proprietary mixtures currently approved for use as inert ingredients in pesticide products should also review their records to ensure that the chemical substances listed in the docket for this action are, in fact, not currently used in their proprietary mixtures.

D. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through https://www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/​dockets/​commenting-epa-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, guidance and the InertFinder tool, can be accessed at https://www.epa.gov/​pesticide-registration/​inert-ingredients-regulation.

B. Why is EPA taking this action?

PFAS are synthetic organic compounds that do not occur naturally in the environment but have widespread use in commerce. The strong carbon-fluorine bonds of PFAS make some of them resistant to degradation and thus highly persistent in the environment. Some PFAS have been detected in wildlife and in humans, indicating that at least some PFAS have the ability to bioaccumulate. Thus, exposure to PFAS is an urgent public health and environmental issue in the United States. As part of its strategic roadmap to address risks posed by PFAS ( https://www.epa.gov/​system/​files/​documents/​2021-10/​pfas-roadmap_​final-508.pdf), EPA identified some specific actions to further the Agency's directives to research, restrict, and remediate PFAS.

EPA maintains a list of chemical substances that have been approved for use as inert ingredients in pesticide products. Inert ingredients on this list do not need further approval prior to inclusion in a pesticide formulation for a non-food use. These individual formulations are subject to data requirements in 40 CFR part 158, regardless of whether the inert ingredient is on the approved list. If an application for registration of a pesticide product includes inert ingredients not on the approved list, the inert ingredient will need approval and require payment of a fee in accordance with section 33 of FIFRA, 7 U.S.C. 136w-8.

As part of the “whole-of-agency” approach to reduce PFAS use and releases, EPA has reviewed the Agency's list of chemical substances that have been approved for use as inert ingredients in pesticide products to determine whether any of these inert ingredients are PFAS. Based on that review, EPA is proposing the removal of twelve chemicals from the current list of inert ingredients approved for use in pesticide products (given in Unit I.C.) that have been identified as PFAS and for which there are no uses as inert ingredient in any currently registered pesticide products.

After the close of the comment period, EPA will consider all comments received and determine appropriate action.

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

Dated: August 29, 2022.

Michal Freedhoff,

Assistant Administrator, Office of Chemical Safety and Pollution Prevention.