[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Rules and Regulations]
[Pages 10242-10244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03399]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0658; FRL-10474-01-OCSPP]


Penthiopyrad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
penthiopyrad in or on banana. Interregional Research Project Number 4, 
IR-4, requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective February 17, 2023. Objections and 
requests for hearings must be received on or before April 18, 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-2021-0658, 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/.

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) 506-2875; 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//title-40.

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-2021-0658 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 
April 18, 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-2021-0658, 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.
    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 November 17, 2022 (87 FR 68959) (FRL-
9410-07-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 1E8951) by IR-4, NC State University, 1730 Varsity Drive, 
Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 
40 CFR 180.658 be amended to establish a tolerance for residues of the 
fungicide penthiopyrad, N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-
(trifluoromethyl)-1H-pyrazole-4-carboxamide, in or on banana at 2 parts 
per million (ppm). That document referenced a summary of the petition 
prepared by IR-4, the petitioner, which is available in the docket, 
https://www.regulations.gov. There were no comments received in 
response to the Notice 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 establishing the tolerance for residues of penthiopyrad in or on 
banana at a different level than requested by the petitioner. The 
reason for this change is 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. . . 
.''

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    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 penthiopyrad including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with penthiopyrad follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections that repeat what has been 
previously published for tolerance rulemaking of the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemaking and republishing the same sections is unnecessary. 
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 a number of tolerance rulemakings for 
penthiopyrad, in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to penthiopyrad and established a 
tolerance 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 penthiopyrad, see Unit III.A. of the June 6, 2019, 
rulemaking (84 FR 26352) (FRL-9994-08).
    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern for 
penthiopyrad used for human risk assessment, see Unit III.B. of the 
June 6, 2019, rulemaking.
    Exposure assessment. Much of the exposure assessment remains the 
same although updates have occurred to accommodate exposures from the 
petitioned-for tolerance. These updates are discussed in this section; 
for a description of the rest of the EPA approach to and assumptions 
for the exposure assessment, please reference Unit III.C. of the June 
6, 2019, rulemaking.
    EPA's dietary exposure assessments have been updated to include the 
additional exposure from the new use of penthiopyrad on banana and were 
conducted with Dietary Exposure Evaluation Model software using the 
Food Commodity Intake Database (DEEM-FCID) Version 4.02, which uses the 
2005-2010 food consumption data from the United States Department of 
Agriculture's (USDA's) National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). The assessment used the 
same assumptions as the June 6, 2019, final rule concerning tolerance-
level residues, default processing factors for all processed 
commodities and 100 percent crop treated.
    Drinking water exposure. The drinking water numbers have not 
changed since the June 6, 2019, rulemaking.
    Non-occupational exposure. There are no new residential (non-
occupational) exposures associated with the new proposed use. The 
assessment of exposures to the currently registered uses on residential 
sites (e.g., lawns and turf) has not changed since the June 6, 2019, 
rulemaking.
    Cumulative exposure. 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.'' 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 penthiopyrad and any other substances and 
penthiopyrad does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this action, therefore, EPA has 
not assumed that penthiopyrad has a common mechanism of toxicity with 
other substances.
    Safety factor for infants and children. EPA continues to conclude 
that there are reliable data to support the reduction of the Food 
Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit 
III.D. of the June 6, 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 
dietary exposure estimates to the acute population adjusted dose (aPAD) 
and the 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.
    Acute dietary risks are below the Agency's level of concern of 100% 
of the aPAD; they are 21% of the aPAD for all infants (less than 1 year 
old), the population subgroup with the highest exposure estimate. 
Chronic dietary risks are below the Agency's level of concern of 100% 
of the cPAD; they are 38% of the cPAD for all infants (less than 1 year 
old), the population subgroup with the highest exposure estimate.
    The combined short-term food, water, and residential exposures 
result in aggregate MOEs of 440 in adults and 220 for children 1 to <2 
years old. Because EPA's level of concern for penthiopyrad is an MOE of 
100 or below, these MOEs are not of concern. For more details, refer to 
unit III.E in the June 6, 2019, rulemaking and unit III.B of the April 
7, 2021, rulemaking (86 FR 17917) (FRL-10017-27). As explained in unit 
III.E. in the June 6, 2019, rulemaking, EPA has concluded that the 
cancer risk is not of concern. Based on the risk assessments and 
information described above, EPA concludes there is reasonable 
certainty that no harm will result to the general population, or to 
infants and children, from aggregate exposure to penthiopyrad residues. 
More detailed information can be found at https://www.regulations.gov 
in the document titled ``Penthiopyrad. Human Health Risk Assessment for 
the Proposed Registrations on Bananas and Greenhouse-Grown Lettuce'' in 
docket ID number EPA-HQ-OPP-2021-0658.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the June 6, 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 has not established an MRL for residues of penthiopyrad 
in or on banana.

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C. Revisions to Petitioned-For Tolerances

    EPA is establishing the tolerance for residues of penthiopyrad in 
or on bananas at 3 ppm instead of the petitioner-proposed 2 ppm. The 2 
ppm value is likely the result of the Day 0 residues input into the 
Organization for Economic Cooperation and Development (OECD) tolerance 
calculator. However, in the residue decline trial, the residue on Day 0 
(0.98 ppm) increased on Day 1 (1.11 ppm) before declining for the 
remainder of the study. As the Day 1 harvest is allowable according to 
the proposed application pattern, it is EPA's practice to use that 
value instead of the Day 0 value. This input results in a tolerance of 
3 ppm according to the OECD tolerance calculation procedures.

V. Conclusion

    Therefore, a tolerance is established for residues of penthiopyrad, 
including its metabolites and degradates, in or on banana at 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 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: February 14, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA amends 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.  180.658, amend table 1 to paragraph (a)(1) by adding, in 
alphabetical order, an entry for ``Banana'' to read as follows:


Sec.  180.658   Penthiopyrad; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Banana.....................................................           3
 
                                * * * * *
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[FR Doc. 2023-03399 Filed 2-16-23; 8:45 am]
BILLING CODE 6560-50-P


