Proposed Rule2023-18050
Phenol; Revoking Exemption From the Requirement of a Pesticide Tolerance
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
August 22, 2023
Issuing agencies
Environmental Protection Agency
Abstract
EPA is proposing to revoke the tolerance exemption for residues of the antimicrobial pesticide ingredient phenol when used as an inert ingredient (solvent/cosolvent) in pesticide formulations applied to growing crops. This rulemaking is proposed on the Agency's own initiative under the Federal Food, Drug, and Cosmetic Act (FFDCA) to implement a tolerance action the Agency determined was appropriate during the registration review conducted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for phenol. EPA is proposing to revoke this tolerance exemption because it corresponds to a use no longer current or registered under FIFRA in the United States.
Full Text
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<title>Federal Register, Volume 88 Issue 161 (Tuesday, August 22, 2023)</title>
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[Federal Register Volume 88, Number 161 (Tuesday, August 22, 2023)]
[Proposed Rules]
[Pages 57026-57029]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-18050]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0409; FRL-11232-01-OCSPP]
RIN 2070-ZA16
Phenol; Revoking Exemption From the Requirement of a Pesticide
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to revoke the tolerance exemption for
residues of the antimicrobial pesticide ingredient phenol when used as
an inert ingredient (solvent/cosolvent) in pesticide formulations
applied to growing crops. This rulemaking is proposed on the Agency's
own initiative under the Federal Food, Drug, and Cosmetic Act (FFDCA)
to implement a tolerance action the Agency determined was appropriate
during the registration review conducted under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) for phenol. EPA is proposing to
revoke this tolerance exemption because it corresponds to a use no
longer current or registered under FIFRA in the United States.
DATES: Comments must be received on or before October 23, 2023.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2023-0409, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Anita Pease, Antimicrobials Division
(7508P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
202-566-0736; email address: <a href="/cdn-cgi/l/email-protection#c4b4a1a5b7a1eaa5aaadb0a584a1b4a5eaa3abb2"><span class="__cf_email__" data-cfemail="a4d4c1c5d7c18ac5cacdd0c5e4c1d4c58ac3cbd2">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
[[Page 57027]]
I. General Information
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 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> Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
<bullet> Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
<bullet> Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
<bullet> Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2023-0409, in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
October 23, 2023. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2023-0409, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <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 CBI or other
information whose disclosure is restricted by statute.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or 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>.
II. Background
A. What action is the Agency taking?
EPA is proposing to revoke the tolerance exemption in 40 CFR
180.920 for residues of the antimicrobial pesticide ingredient phenol
when used as an inert ingredient (solvent/cosolvent) in pesticide
formulations applied to growing crops, because this tolerance exemption
corresponds to a use no longer current or registered under FIFRA in the
United States.
B. What is the Agency's authority for taking this action?
EPA is proposing this action pursuant to its authority under
section 408 of the FFDCA, 21 U.S.C. 346a. The Agency previously
determined this action was appropriate during the registration review
of phenol conducted under FIFRA, 7 U.S.C. 136 et seq.
Under FIFRA section 3(g), 7 U.S.C. 136a(g), EPA is required to
periodically review all registered pesticides and determine if those
pesticides continue to meet the standard for registration under FIFRA.
See also 40 CFR 155.40(a). As part of registration review, EPA
evaluates whether existing tolerances are safe, whether any changes to
existing tolerances are necessary or appropriate, and whether any new
tolerances are necessary. A ``tolerance'' represents the maximum level
for residues of pesticide chemicals legally allowed in or on raw
agricultural commodities and processed foods. Section 408 of FFDCA, 21
U.S.C. 346a, authorizes the establishment, modification, and revocation
of tolerances or exemptions from the requirement of a tolerance for
residues of pesticide chemicals in or on raw agricultural commodities
and processed foods. Residues of pesticides in or on food that are not
covered by a tolerance or exemption are deemed unsafe, 21 U.S.C.
346a(a)(1). Any food containing unsafe residues is considered
adulterated and may not be distributed in interstate commerce, 21
U.S.C. 331(a), 342(a)(2)(B). For a food-use pesticide to be sold and
distributed, the pesticide must not only have appropriate tolerances
under the FFDCA but also must be registered under FIFRA, 7 U.S.C. 136
et seq. Moreover, residues of food-use pesticides not registered in the
United States must also be covered by a tolerance or exemption in order
for commodities treated with those pesticides to be imported into the
United States.
Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement of a tolerance only if EPA determines
that the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA
defines ``safe'' to mean that ``there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information.'' This includes
exposure through drinking water and in residential settings but does
not include occupational exposure. Section 408(c)(2)(B) of the FFDCA
requires EPA, when making a safety determination concerning an
exemption, to take into account, among other relevant considerations,
the considerations listed in section 408(b)(2)(C) and (D). Section
408(b)(2)(C) requires EPA to give special consideration to exposure of
infants and children to the pesticide chemical residue and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .'' Section 408(b)(2)(D) identifies various factors,
including available information on aggregate and cumulative exposure,
for EPA's consideration in making a safety determination.
Section 408(e) of the FFDCA, 21 U.S.C. 346a(e), authorizes EPA to
initiate a rulemaking to establish, modify, or revoke tolerances or
exemptions from the requirement of a tolerance on its own initiative.
Prior to issuing the final regulation, section 408(e)(2) requires EPA
to issue a notice of proposed rulemaking for a 60-day public comment
period, unless the
[[Page 57028]]
Administrator for good cause finds that it would be in the public
interest to have a shorter period and states the reasons in the
rulemaking.
Consistent with its obligations under FIFRA section 3(g) and FFDCA
section 408, EPA has reviewed the available scientific data and other
relevant information and determined it is appropriate to take the
action being proposed in this rulemaking.
C. When does this action become effective?
EPA is proposing that this action become effective six months after
the date of publication of the final rule in the Federal Register. EPA
is proposing this effective date for this action to allow a reasonable
interval for producers in exporting members of the World Trade
Organization's (WTO's) Sanitary and Phytosanitary (SPS) Measures
Agreement to adapt to the requirements of the final rule.
Any commodities treated with phenol in the channels of trade
following the tolerance exemption revocation shall be subject to FFDCA
section 408(l)(5), 21 U.S.C. 346a(l)(5). Under this section, any
residues of this pesticide in or on such food shall not render the food
adulterated so long as it is shown to the satisfaction of the Food and
Drug Administration that the residue is present as the result of an
application or use of the pesticide at a time and in a manner that was
lawful under FIFRA and the residue does not exceed the level that was
authorized at the time of the application or use to be present on the
food under a tolerance or exemption, unless EPA determines that
consumption of legally treated food during the period of its likely
availability in commerce will pose unreasonable dietary risk. Evidence
to show that food was lawfully treated may include records that verify
the dates when the pesticide was applied to such food.
III. Proposed Rule
EPA is proposing to revoke the tolerance exemption in 40 CFR
180.920 for residues of phenol when used as an inert ingredient
(solvent/cosolvent) in pesticide formulations applied to growing crops.
In the August 2020 Phenol and Salt Interim Registration Review Decision
(available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in docket ID number EPA-HQ-
OPP-2012-0810), EPA determined that there are no current registrations
for pesticide products containing phenol as an inert ingredient
(solvent/cosolvent) for use on growing crops, and therefore the
tolerance exemption for phenol under 40 CFR 180.920 is not necessary
and should be revoked. Moreover, there have been no registrations for
use associated with this tolerance exemption for many years. The Agency
therefore believes that existing stocks of pesticide products
containing phenol for the use associated with this tolerance exemption
have been exhausted and that treated commodities have cleared the
channels of trade.
IV. Conclusion
Therefore, EPA is proposing to revoke the exemption from the
requirement of a tolerance for residues of phenol when used as an inert
ingredient (solvent/cosolvent) in pesticide products used on growing
crops.
V. Statutory and Executive Order Reviews
In this proposed rule, EPA is proposing to revoke a specific
tolerance exemption under its authority in FFDCA section 408(e). The
Office of Management and Budget (OMB) has exempted this type of action
(e.g., tolerance exemption revocation for which extraordinary
circumstances do not exist) from review under Executive Order 12866,
entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4,
1993). Because this proposed rule has been exempted from review under
Executive Order 12866, due to its lack of significance, this proposed
rule is not subject to Executive Order 13211, entitled ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001). This proposed rule
does not contain any information collections subject to OMB approval
under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.) or
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (UMRA) (2
U.S.C. 1501 et seq.). Nor does it require any special considerations as
required by Executive Order 12898, entitled ``Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994); or OMB review or any
other Agency action under Executive Order 13045, entitled ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This proposed rule does not involve any
technical standards that would require Agency consideration of
voluntary consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency previously assessed whether revocations of tolerances
might significantly impact a substantial number of small entities and
concluded that, as a general matter, these actions do not impose a
significant economic impact on a substantial number of small entities.
This analysis was published in the Federal Register of December 17,
1997 (62 FR 66020) (FRL-5753-1) and was provided to the Chief Counsel
for Advocacy of the Small Business Administration. Taking into account
this analysis, and available information concerning the pesticide named
in this proposed rule, the Agency hereby certifies that this proposed
rule will not have a significant negative economic impact on a
substantial number of small entities. In a memorandum dated May 25,
2001, EPA determined that eight conditions must all be satisfied in
order for an import tolerance or tolerance exemption revocation to
adversely affect a significant number of small entity importers, and
that there is a negligible joint probability of all eight conditions
holding simultaneously with respect to any particular revocation. (This
Agency document titled ``RFA/SBREFA Certification for Import Tolerance
Revocation'' is available in the docket of this proposed rule.)
Furthermore, for the pesticide named in this proposed rule, the Agency
knows of no extraordinary circumstances that exist as to the present
proposed rule that would change EPA's previous analysis. Any comments
about the Agency's determination should be submitted to the EPA along
with comments on the proposed rule and will be addressed prior to
issuing a final rule.
In addition, the Agency has determined that this proposed rule will
not have a substantial direct effect on States, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999). Executive Order 13132, requires EPA to develop
an accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the National Government and the States, or on the
distribution of power and
[[Page 57029]]
responsibilities among the various levels of government.'' This
proposed rule directly regulates growers, food processors, food
handlers, and food retailers, not States. This proposed rule does not
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of FFDCA section
408(n)(4). For these same reasons, the Agency has determined that this
proposed rule does not have any ``tribal implications'' as described in
Executive Order 13175, entitled ``Consultation and Coordination with
Indian Tribal Governments'' (65 FR 67249, November 9, 2000). Executive
Order 13175, requires EPA to develop an accountable process to ensure
``meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications.'' ``Policies that
have tribal implications'' is defined in the Executive Order to include
regulations that have ``substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.'' This proposed rule
will not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175, does not apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 14, 2023.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
Sec. 180.920 [Amended]
0
2. In Sec. 180.920, amend table 1 by removing the inert ingredient
``Phenol''.
[FR Doc. 2023-18050 Filed 8-21-23; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on August 22, 2023.
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.