[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Notices]
[Pages 76488-76490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27085]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2022-0542; FRL-9985-02-OCSPP]


Pesticides; Removal of PFAS Chemicals From Approved Inert 
Ingredient List for Pesticide Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is removing 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: This action is applicable December 14, 2022.

FOR FURTHER INFORMATION CONTACT: Dan Rosenblatt, Registration Division 
(7505T), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (202) 566-1030; email address: [email protected].

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

[[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).
 [alpha]-(Cyclohexylmethyl)-[omega]-
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), [alpha]-chloro-[omega]-(1-chloro-1-
fluoroethyl) (CAS Reg. No. 131324-06-6).
 Poly(difluoromethylene), [alpha]-chloro-[omega]-(2,2-dichloro-
1,1,2-trifluoroethyl)-(CAS Reg. No. 79070-11-4).
 Poly(difluoromethylene), [alpha]-(2,2-dichloro-2-fluoroethyl)-
, [omega]-hydro- (CAS No. 163440-89-9).
 Poly(difluoromethylene), [alpha]-fluoro-[omega]-[2-[(2-methyl-
1-oxo-2-propenyl)oxy]ethyl]- (CAS Reg. No. 65530-66-7).
 Poly(oxy-1,2-ethanediyl), [alpha]-hydro-[omega]-hydroxy-, 
ether with [alpha]-fluoro-[omega]-(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

[[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.

    Dated: December 8, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2022-27085 Filed 12-13-22; 8:45 am]
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