Rule2023-18410
Methoxyfenozide; Pesticide Tolerances
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 28, 2023
Effective
August 28, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of methoxyfenozide in or on coffee bean, sugar cane, and sugar cane molasses. There are no U.S. registrations associated with these tolerances. Corteva Agrisciences, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 88 Issue 165 (Monday, August 28, 2023)</title>
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[Federal Register Volume 88, Number 165 (Monday, August 28, 2023)]
[Rules and Regulations]
[Pages 58506-58509]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-18410]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0139; FRL-11276-01-OCSPP]
Methoxyfenozide; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
methoxyfenozide in or on coffee bean, sugar cane, and sugar cane
molasses. There are no U.S. registrations associated with these
tolerances. Corteva Agrisciences, LLC requested these tolerances under
the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 28, 2023. Objections and
requests for hearings must be received on or before October 27, 2023,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2022-0139, 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. For the latest
status information on EPA/DC services, docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, 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#3a687e7c6874554e53595f497a5f4a5b145d554c"><span class="__cf_email__" data-cfemail="05574143574b6a716c666076456075642b626a73">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
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).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 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(g), 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-2022-0139 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 27, 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-2022-0139, 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/contacts.html">https://www.epa.gov/dockets/contacts.html</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. Summary of Petitioned-For Tolerance
In the Federal Register of July 5, 2023 (88 FR 42935) (FRL-10579-
05), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1E8910) by Corteva Agriscience LLC, 9330 Zionsville Rd., Indianapolis,
IN 46268. The petition requested that 40 CFR 180.544 be amended by
establishing tolerances for residues of the insecticide
methoxyfenozide, including its metabolites and degradates, in or on
coffee at 0.15 parts per million (ppm) and sugarcane at 0.03 ppm and in
the processed commodity sugarcane molasses at 0.1 ppm. Compliance with
the tolerance levels is to be determined by measuring only
methoxyfenozide (3-methoxy-2-methylbenzoic acid 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide). That document
referenced a summary of the petition prepared by Corteva Agrisciences,
LLC, which is available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
There were no comments received in response to the notice of filing.
[[Page 58507]]
Based upon review of the data supporting the petition, EPA has
recommended revisions in commodity definitions. The reasons for these
changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of 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(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance 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 . .
. .''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for methoxyfenozide including exposure resulting
from the tolerances established by this action. EPA's assessment of
exposures and risks associated with methoxyfenozide follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published in tolerance rulemakings for the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings, and EPA considers referral back to those
sections as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
EPA has previously published tolerance rulemakings for
methoxyfenozide in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to methoxyfenozide and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections from those rulemakings as described
further in this rulemaking, as they remain unchanged.
Toxicological profile. For a discussion of the Toxicological
Profile of methoxyfenozide, see Unit III.A. of the methoxyfenozide
tolerance rulemaking published in the Federal Register of March 12,
2019 (84 FR 8820) (FRL-9985-06).
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
methoxyfenozide used for human health risk assessment, see Unit III.B.
of the March 12, 2019, rulemaking.
Exposure assessment. Much of the exposure assessment for
methoxyfenozide remains unchanged from the discussions in Unit III.C.
of the March 12, 2019, rulemaking and Unit III.C. of the
methoxyfenozide tolerance rulemaking published in the Federal Register
of October 11, 2022 (87 FR 61259) (FRL-9525-01), except as described
below.
Dietary exposure from food and feed uses. The exposure assessment
has been updated to include the additional dietary exposure from the
new tolerances for residues of methoxyfenozide on coffee bean and sugar
cane commodities using the same previous assumptions of tolerance level
residues and 100 percent crop treated (PCT) described in Unit III.C.1.
of the March 12, 2019, rulemaking.
Dietary exposure from drinking water. Because the requested
tolerances for residues of methoxyfenozide in or on coffee bean and
sugar cane commodities do not include registrations for use on coffee
bean and sugar cane commodities in the United States, the estimated
drinking water concentrations have not changed. For a detailed summary
of the drinking water analysis for methoxyfenozide used for the human
health risk assessment, see Unit III.C.2. of the March 12, 2019,
rulemaking and Unit III.C. of the October 11, 2022, rulemaking.
Non-occupational exposure. As described in Unit III.C. of the
October 11, 2022, rulemaking, the Agency assumes that when labels
require specific clothing and/or personal protective equipment (PPE)
such products are not for residential use. The methoxyfenozide label
requires specific clothing and/or PPE; therefore, the Agency has made
the assumption that the registered methoxyfenozide labels are not
intended for use by residential handlers and a quantitative residential
handler assessment has not been conducted. The approach to assessing
post-application exposure is the same as described in Unit III.C.3 of
the March 12, 2019, rulemaking.
Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' In 2016, EPA's Office of
Pesticide Programs released a guidance document entitled Pesticide
Cumulative Risk Assessment: ``Framework for Screening Analysis''
(<a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework</a>). This document provides
guidance on how to screen groups of pesticides for cumulative
evaluation using a two-step approach beginning with the evaluation of
available toxicological information and, if necessary, followed by a
risk-based screening approach. This framework supplements the existing
guidance documents for establishing common mechanism groups (CMGs) and
conducting cumulative risk assessments (CRA).
The Agency has utilized this framework for methoxyfenozide and
determined that the diacylhydrazine class of insecticides
(methoxyfenozide, halofenozide and tebufenozide) form a candidate CMG.
This group of pesticides is considered a candidate CMG because they
share characteristics to support a testable hypothesis for a common
mechanism of action.
Following this determination, the Agency conducted a screening-
level cumulative risk assessment consistent with the 2016 guidance
document. This assessment included only methoxyfenozide and
tebufenozide since there are no registered uses for halofenozide. The
current screening assessments for methoxyfenozide and tebufenozide are
below the Agency's levels of concern. No further cumulative evaluation
is necessary for methoxyfenozide.
For more information, see Appendix E of the document titled
``Methoxyfenozide. Human Health Risk Assessment for the Petition to
Establish Permanent Tolerances without a U.S. Registration on Coffee
Beans and Sugar Cane,'' available at docket ID number EPA-HQ-OPP-2022-
0139.
Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection
[[Page 58508]]
Act (FQPA) safety factor from 10X to 1X. See Unit III.D. of the March
12, 2019, rulemaking for a discussion of the Agency's rationale for
that determination.
Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population adjusted dose
(aPAD) and chronic population adjusted dose (cPAD). Short-,
intermediate-, and chronic-term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate margin of
exposure (MOE) exists. For linear cancer risks, EPA calculates the
lifetime probability of acquiring cancer given the estimated aggregate
exposure.
An acute dietary risk assessment was not needed for methoxyfenozide
since no toxic effects attributable to a single dose were identified in
the toxicity database. Chronic dietary risks are below the Agency's
level of concern of 100% of the cPAD; they are 78% of the cPAD for
children 1 to 2 years old, the group with the highest exposure. There
are currently no residential handler uses for methoxyfenozide, and none
are pending before the Agency. Therefore short- and intermediate-term
exposure to methoxyfenozide is not expected, and the short- and
intermediate-term risk is equivalent to the chronic dietary risk, which
is not of concern. Methoxyfenozide is classified as ``Not Likely to Be
Carcinogenic to Humans''; therefore, EPA does not expect
methoxyfenozide exposures to pose an aggregate cancer risk.
Determination of safety. Therefore, based on the risk assessments
and information described above, EPA concludes there is a reasonable
certainty that no harm will result to the general population, or to
infants and children, from aggregate exposure to methoxyfenozide
residues. More detailed information on this action can be found in the
document titled ``Methoxyfenozide. Human Health Risk Assessment for the
Petition to Establish Permanent Tolerances without a U.S. Registration
on Coffee Beans and Sugar Cane,'' available at docket ID number EPA-HQ-
OPP-2022-0139.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the March 12, 2019, rulemaking.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for methoxyfenozide in/on
coffee bean or sugar cane commodities.
C. Revisions to Petitioned-For Tolerances
EPA is changing the commodity definitions from coffee to coffee
bean, sugarcane to sugar cane, and sugarcane, molasses to sugar cane,
molasses to be consistent with Agency nomenclature.
V. Conclusion
Therefore, tolerances are established for residues of
methoxyfenozide, in or on coffee bean at 0.15 ppm, sugar cane at 0.03
ppm, and sugar cane, molasses at 0.1 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action 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), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the National Government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In addition,
this action does not 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.).
This action 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).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides
[[Page 58509]]
and pests, Reporting and recordkeeping requirements.
Dated: August 18, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I 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.
0
2. In Sec. 180.544, in paragraph (a)(1) amend the table by:
0
a. Adding in alphabetical order the entries ``Coffee bean''; ``Sugar
cane''; and ``Sugar cane, molasses''; and
0
b. Adding footnote 2 at the end of the table.
The additions read as follows:
Sec. 180.544 Methoxyfenozide; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Coffee bean \2\............................................. 0.15
* * * * *
Sugar cane \2\.............................................. 0.03
Sugar cane, molasses \2\.................................... 0.1
* * * * *
------------------------------------------------------------------------
* * * * *
\2\ There are no U.S. registrations as of August 28, 2023.
[FR Doc. 2023-18410 Filed 8-25-23; 8:45 am]
BILLING CODE 6560-50-P
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