Cyclaniliprole; Pesticide Tolerance, 30277-30280 [2024-08022]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[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 [www.gpo.gov]
[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 
https://www.regulations.gov 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 https://www.epa.gov/dockets.

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: 
[email protected].

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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     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 https://www.ecfr.gov/current/title-40.

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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
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.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

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 https://www.regulations.gov. 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,

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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 https://www.regulations.gov 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: [email protected].

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

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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.

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                        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