Document ID: EPA-HQ-OPP-2022-0542-0001
Agency: epa
Document Type: Notice
Title: Pesticides: Proposed Removal of per- and polyfluoroalkyl Substance Chemicals from Approved Inert Ingredient List for Pesticide Products
Posted Date: 2022-09-13T04:00Z

[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56051-56053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19008]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2022-0542; FRL-9985-01-OCSPP]

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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: (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 engage in 
activities related to the registration of pesticide products, including 
but not limited to, the use of approved inert ingredients

[[Page 56052]]

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)
     [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); 
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

[[Page 56053]]

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.
[FR Doc. 2022-19008 Filed 9-12-22; 8:45 am]
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