Rule2024-08022
Cyclaniliprole; 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
April 23, 2024
Effective
April 23, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes a tolerance for residues of cyclaniliprole in or on Vegetable, cucurbit, group 9. Interregional Research Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 89 Issue 79 (Tuesday, April 23, 2024)</title>
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[Federal Register Volume 89, Number 79 (Tuesday, April 23, 2024)]
[Rules and Regulations]
[Pages 30277-30280]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-08022]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0077; FRL-11855-01-OCSPP]
Cyclaniliprole; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
cyclaniliprole in or on Vegetable, cucurbit, group 9. Interregional
Research Project Number 4 (IR-4) requested this tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April 23, 2024. Objections and
requests for hearings must be received on or before June 24, 2024, and
must be filed in
[[Page 30278]]
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-2023-0077, 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: 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#c4968082968aabb0ada7a1b784a1b4a5eaa3abb2"><span class="__cf_email__" data-cfemail="e7b5a3a1b5a988938e848294a7829786c9808891">[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-2023-0077 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
June 24, 2024. 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-2023-0077, 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. Summary of Petitioned-For Tolerance
In the Federal Register of February 9, 2024 (89 FR 9103) (FRL-
10579-12-OCSPP), 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 2E9037) by IR-4, North Carolina State University, 1730
Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition
requested to establish a tolerance for residues of the insecticide
cyclaniliprole, 3-bromo-N-[2-bromo-4-chloro-6-[[(1-
cyclopropylethyl)amino carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-
pyrazole-5-carboxamide, including its metabolites and degradates, in or
on the raw agricultural commodity Vegetable, cucurbit, group 9 at 0.3
parts per million (ppm). Upon the establishment of the tolerance
specified above, IR-4 requested to remove the established tolerance for
Vegetable, cucurbit, group 9 at 0.15 ppm. The document referenced a
summary of the petition, which is available in the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no comments received in response to the
notice of filing.
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 cyclaniliprole, including exposure resulting
from the tolerance established by this action. EPA's assessment of
exposures and risks associated with cyclaniliprole follows.
No single or repeated dose study performed by any route of exposure
produced an adverse effect following cyclaniliprole exposure at dose
levels below, at, or above the limit dose (1,000 milligrams/kilogram/
day (mg/kg/day)). Although the oral toxicity studies in dogs were
conducted at approximately a third of the limit dose, no adverse
effects were seen. While adaptive liver effects were seen in these
studies, it is unlikely that cyclaniliprole would produce adverse liver
effects if tested at higher doses in dogs as a structurally related
chemical, chlorantraniliprole,
[[Page 30279]]
was tested up to the limit dose in dogs and did not demonstrate adverse
liver effects. There is no evidence that cyclaniliprole produces
increased susceptibility with prenatal or postnatal exposures.
Cyclaniliprole is considered not likely to be carcinogenic based on no
increase in treatment-related tumor incidence in carcinogenicity
studies in rats and mice and no genotoxicity.
Specific information on the studies received for cyclaniliprole as
well as the no-observed-adverse-effect-level (NOAEL) from the toxicity
studies can be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in document,
``Cyclaniliprole: Human Health Risk Assessment for New Greenhouse Uses
on Lettuce and Cucumber and Amendment of Permanent Tolerances on
Cucurbit Vegetables Crop Group 9'', in docket ID number EPA-HQ-OPP-
2023-0077.
Based on the review of the available cyclaniliprole toxicological
studies, no toxicity endpoints or points of departure were selected for
risk assessment. Based on the toxicological profile of cyclaniliprole,
EPA has concluded that the FFDCA requirements to retain an additional
safety factor for protection of infants and children and to consider
cumulative effects do not apply. Section 408(b)(2)(C) requires an
additional tenfold margin of safety in the case of threshold risks,
which cyclaniliprole does not present. Section 408(b)(2)(D)(v) requires
consideration of information concerning cumulative effects of
substances that have a common mechanism of toxicity. Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to cyclaniliprole and any other substances, and
cyclaniliprole does not appear to produce a toxic metabolite produced
by other substances. For the purposes of this action, therefore, EPA
has not assumed that cyclaniliprole has a common mechanism of toxicity
with other substances.
Cyclaniliprole has been grouped with the pyridyl pyrazoles. As part
of the ongoing process to review registered pesticides, the Agency
intends to apply this framework to determine if the available
toxicological data for cyclaniliprole suggests a candidate common
mechanism group (CMG) may be established with other pesticides. If a
CMG is established, a screening-level toxicology and exposure analysis
may be conducted to provide an initial screen for multiple pesticide
exposure.
There is a potential for exposure to cyclaniliprole residues via
food and drinking water based on existing uses and the proposed uses
for cyclaniliprole application directly to growing crops. These
applications can also result in cyclaniliprole reaching surface and
ground water, both of which can serve as sources of drinking water.
There are no proposed uses in residential settings and therefore no
anticipated residential exposures, although exposures resulting from
spray drift from agricultural applications onto residential areas may
occur. However, no quantitative risk assessment was conducted because
no toxicity endpoints or points of departure were selected for risk
assessment.
Determination of safety. Based on the available data indicating a
lack of adverse effects from exposure to cyclaniliprole, EPA concludes
that there is a reasonable certainty that no harm will result to the
general population, or to infants and children, from aggregate exposure
to cyclaniliprole residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography with tandem
mass spectrometry (LC-MS/MS)) is available to enforce the tolerance
expression for plant and livestock commodities. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Mead, MD 20755-5350; telephone
number: (410) 305-2905; email address: <a href="/cdn-cgi/l/email-protection#f68493859f9283939b93829e999285b6938697d8919980"><span class="__cf_email__" data-cfemail="9eecfbedf7faebfbf3fbeaf6f1faeddefbeeffb0f9f1e8">[email protected]</span></a>.
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).
There are Codex MRLs established for residues of cyclaniliprole on
cucumber and squash (summer) at 0.05 ppm; and melons, pumpkin, squash
(winter) at 0.1 ppm which are different than the U.S. tolerance for the
cucurbit vegetable group 9 established in this action (0.3 ppm). For
cucurbit vegetable group 9, no harmonization is possible for these
commodities because decreasing the tolerance level to harmonize with
the Codex MRL could put U.S. growers at risk of violative residues
despite legal use of cyclaniliprole.
V. Conclusion
Although the lack of toxicity supports a safety finding for an
exemption from the requirement of tolerance for all crops, EPA is
revising the tolerance for residues resulting from direct applications
to the cucurbit vegetable group 9 because the petitioner requested it
for international trade purposes. Therefore, the tolerance for residues
of cyclaniliprole in or on Vegetable, cucurbit, group 9 is revised from
0.15 ppm to 0.3 ppm.
VI. Statutory and Executive Order Reviews
This action establishes a tolerance 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 to 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 tolerance 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
[[Page 30280]]
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, and pests, Reporting and
recordkeeping requirements.
Dated: April 11, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter 1 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. 180.694, amend Table 1 to Paragraph (a) by revising the
entry for ``Vegetable, cucurbit, group 9'' to read as follows:
Sec. 180.694 Cyclaniliprole; tolerances for residues.
* * * * *
Table 1 to Paragraph (a)
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Commodity Parts per million
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* * * * * * *
Vegetable, cucurbit, group 9........................ 0.3
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[FR Doc. 2024-08022 Filed 4-22-24; 8:45 am]
BILLING CODE 6560-50-P
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