[Federal Register Volume 87, Number 222 (Friday, November 18, 2022)]
[Rules and Regulations]
[Pages 69201-69204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25185]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0387; FRL-10030-01-OCSPP]


Cyclaniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyclaniliprole in or on multiple crops that are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective November 18, 2022. Objections and 
requests for hearings must be received on or before January 17, 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-2021-0387, 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. For the latest 
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Acting 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.

[[Page 69202]]

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-2021-0387 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 
January 17, 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-2021-0387, 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 October 21, 2021 (86 FR 58239) (FRL-
8792-04-OCSPP) and April 28, 2022 (87 FR 25178) (FRL-9410-12-OCSPP), 
EPA issued documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 1E8904) 
by IR-4, North Carolina State University, 1730 Varsity Drive, Venture 
IV, Suite 210, Raleigh, NC 27606. The petition requested to establish 
tolerances 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 commodities: 
Artichoke, globe at 1.5 parts per million (ppm); Pepper/eggplant 
subgroup 8-10B at 1.5 ppm; Sunflower subgroup 20B at 0.4 ppm; Tomato 
subgroup 8-10A at 0.6 ppm; Hog, meat at 0.01 ppm; Hog, fat at 0.015 
ppm; Hog, meat byproducts at 0.015 ppm; Egg at 0.01 ppm; Poultry, meat 
at 0.01 ppm; Poultry, fat at 0.015 ppm; and Poultry, meat byproducts at 
0.015 ppm. Upon the establishment of the tolerances specified above, 
IR-4 requested to remove the established tolerance for Vegetable, 
fruiting, group 8-10 at 0.20 ppm. The documents referenced a summary of 
the petition, which is available in the docket, https://www.regulations.gov. There were no substantive comments received in 
response to the notices of filing.
    Based upon review of the data supporting the petition and in 
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA 
is modifying the commodities for which tolerances are being set.

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 tolerances 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, 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 the Proposed New 
Uses on Globe Artichoke and Sunflower Subgroup 20B and for new 
Greenhouse Uses (with Amended Tolerances) on Tomato Subgroup 8-10A and 
Pepper/Eggplant Subgroup 8-10B'', in docket ID number EPA-HQ-OPP-2021-
0387.
    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

[[Page 69203]]

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 existing or 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 plants and livestock commodities. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, 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).
    The Codex has established MRLs for cyclaniliprole. The tolerance 
definitions are harmonized between the U.S. and Codex for plant and 
livestock commodities. There are Codex MRLs established on tomato 
subgroup 8-10A at 0.08 ppm for most commodities and at 0.1 ppm for 
tomato and on pepper/eggplant subgroup 8-10B at 0.15 ppm. For peppers 
(bell/non-bell) and tomatoes, the Agency is not harmonizing with the 
Codex MRLs because the Codex MRLs are much lower than the U.S. 
tolerances (0.15 vs 1.5 ppm for pepper subgroup and 0.1 vs 0.7 ppm for 
tomato subgroup). Harmonization could potentially result in tolerance 
exceedances in the U.S. and is therefore not possible.

C. Revisions to Petitioned-For Tolerances

    The Agency has revised the tolerance value for tomato subgroup 8-
10A from 0.6 ppm to 0.7 ppm because EPA used different residue data to 
calculate the tolerance. The proposed preharvest interval (PHI) for 
tomato is 1 day and the petitioner used residue data from a 1-day PHI. 
The decline trial indicated that residues increased at higher PHIs, so 
EPA included the highest cyclaniliprole residue at a PHI of 7 days in 
the tolerance calculation to be conservative.
    EPA has determined that tolerances for Hog, meat; Hog, fat; Hog, 
meat byproducts; Egg; Poultry, meat; Poultry, fat; and Poultry, meat 
byproducts are not necessary because the calculated dietary burdens for 
swine and poultry are very low such that there is no reasonable 
expectation of finite residues in these commodities as a result of 
eating treated feedstuff (40 CFR 180.6(a)(3)).

V. Conclusion

    Although the lack of toxicity supports a safety finding for an 
exemption from the requirement of tolerance for all crops, EPA is 
establishing tolerances for residues resulting from direct applications 
to certain commodities because the petitioner requested them for 
international trade purposes. Therefore, tolerances are established for 
residues of cyclaniliprole in or on Artichoke, globe at 1.5 ppm; 
Pepper/eggplant subgroup 8-10B at 1.5 ppm; Sunflower subgroup 20B at 
0.4 ppm; and Tomato subgroup 10A at 0.7 ppm. Additionally, the 
tolerance for Vegetable, fruiting, group 8-10 is removed as 
unnecessary.

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 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 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

[[Page 69204]]

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: November 15, 2022.
Daniel Rosenblatt,
Acting 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 the table in paragraph (a) by:
0
a. Adding a heading;
0
b. Adding in alphabetical order the entries ``Artichoke, globe'', 
``Pepper/eggplant subgroup 8-10B'', ``Sunflower subgroup 20B'', and 
``Tomato subgroup 8-10A''; and
0
c. Removing the entry for ``Vegetable, fruiting, group 8-10''.
    The additions read as follows:


Sec.  180.694   Cyclaniliprole; tolerances for residues.

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                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Artichoke, globe............................................         1.5
 
                                * * * * *
Pepper/eggplant subgroup 8-10B..............................         1.5
 
                                * * * * *
Sunflower subgroup 20B......................................         0.4
 
                                * * * * *
Tomato subgroup 8-10A.......................................         0.7
 
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. 2022-25185 Filed 11-17-22; 8:45 am]
BILLING CODE 6560-50-P


