Notice2022-19008
Pesticides; Proposed Removal of PFAS Chemicals From Approved Inert Ingredient List for Pesticide Products
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 13, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 176 (Tuesday, September 13, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56051-56053]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19008]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#5f0d1b190d11302b363c3a2c1f3a2f3e71383029"><span class="__cf_email__" data-cfemail="62302624302c0d160b010711220712034c050d14">[email protected]</span></a>.
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:
<bullet> 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:
<bullet> 2-Chloro-1,1,1,2-tetrafluoroethane (CAS Reg. No. 2837-89-
0)
<bullet> [alpha]-(Cyclohexylmethyl)-[omega]-
hydropoly(difluoromethylene) (CAS Reg. No. 65530-85-0)
<bullet> Dichlorotetrafluoroethane (CAS Reg. No. 1320-37-2)
<bullet> Ethane, 1,1,1,2,2-pentafluoro- (CAS Reg. No. 354-33-6)
<bullet> Hexafluoropropene, polymer with tetrafluoroethylene (CAS
Reg. No. 25067-11-2)
<bullet> Montmorillonite-type clay treated with
polytetrafluoroethylene (No CAS Reg. No.)
<bullet> Poly(difluoromethylene), [alpha]-chloro-[omega]-(1-chloro-
1-fluoroethyl) (CAS Reg. No. 131324-06-6)
<bullet> Poly(difluoromethylene), [alpha]-chloro-[omega]-(2,2-
dichloro-1,1,2-trifluoroethyl)- (CAS Reg. No. 79070-11-4)
<bullet> Poly(difluoromethylene), [alpha]-(2,2-dichloro-2-
fluoroethyl)-, [omega]-hydro- (CAS No. 163440-89-9)
<bullet> Poly(difluoromethylene), [alpha]-fluoro-[omega]-[2-[(2-
methyl-1-oxo-2- propenyl)oxy]ethyl]- (CAS Reg. No. 65530-66-7)
<bullet> 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
<bullet> 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 <a href="https://www.epa.gov/pesticide-registration/inert-ingredients-regulation">https://www.epa.gov/pesticide-registration/inert-ingredients-regulation</a>.
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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
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 <a href="https://www.epa.gov/pesticide-registration/inert-ingredients-regulation">https://www.epa.gov/pesticide-registration/inert-ingredients-regulation</a>.
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 (<a href="https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf">https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf</a>), 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]
BILLING CODE 6560-50-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on September 13, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.