[Federal Register Volume 88, Number 31 (Wednesday, February 15, 2023)]
[Rules and Regulations]
[Pages 9753-9756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03210]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0446; FRL-10195-01-OCSPP]


Pydiflumetofen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
pydiflumetofen in or on caneberry subgroup 13-07A. The Interregional 
Project Number 4 (IR-4) requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 15, 2023. Objections and 
requests for hearings must be received on or before April 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-2021-0446, is available online at 
https://www.regulations.gov or in-person 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.

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-2021-0446 in the subject line on the first 
page of your submission. All objections and requests for a hearing

[[Page 9754]]

must be in writing and must be received by the Hearing Clerk on or 
before April 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-2021-0446, 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/contacts.html. 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 September 22, 2021 (86 FR 52624) (FRL-
8792-03-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 1E8919) by the Interregional Research Project Number 4 
(IR-4), Project Headquarters, North Carolina University, 1730 Varsity 
Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested 
that 40 CFR 180.699 be amended to establish a tolerance for residues of 
the fungicide pydiflumetofen, (3-(difluoromethyl)-N-methoxy-1-methyl-N-
[1-methyl-2-(2,4,6-trichlorophenyl)ethyl]-1H-pyrazole-4-carboxamide) in 
or on caneberry subgroup 13-07A at 4 parts per million (ppm) and to 
revise the tolerance for vegetable, fruiting, group 8-10 from 0.60 ppm 
to 0.8 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 caneberry subgroup 13-07A at a 
different level than petitioned-for and is not increasing the tolerance 
for vegetable, fruiting, group 8-10 to 0.8 ppm. 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 in infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    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 pydiflumetofen including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with pydiflumetofen 
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 
pydiflumetofen, in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to pydiflumetofen 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 pydiflumetofen, see Unit III.A. of the August 12, 2019, 
rulemaking (84 FR 39761) (FRL-9997-09).
    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern for 
pydiflumetofen used for human health risk assessment, see Unit III.B. 
of the May 24, 2018, rulemaking (83 FR 24036) (FRL-9976-66).
    Exposure assessment. Much of the exposure assessment remains the 
same although updates have occurred to accommodate exposures from the 
petitioned-for tolerances. 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 August 
12, 2019, rulemaking.
    Dietary exposure from food and feed uses. EPA's dietary exposure 
assessments have been updated to include the additional exposure from 
the new use on caneberry subgroup 13-07A. The chronic and acute dietary 
(food and drinking water) exposure and risk assessments were conducted 
using the Dietary Exposure Evaluation Model software with the Food 
Commodity Intake Database (DEEM-FCID) Version 4.02, which uses the 
2005-2010 food consumption data from the U.S. Department of 
Agriculture's (USDA's) National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). As with the 2019 
assessments, the chronic and acute dietary risk assessments were 
unrefined, assuming tolerance-level residues, 100% crop treated (100 
PCT) for all commodities, and default processing factors.
    Dietary exposure from drinking water. The new use on caneberry 
subgroup 13-07A does not result in an increase in the estimated residue 
levels in drinking water, so EPA used the same estimated drinking water 
concentrations identified

[[Page 9755]]

in Unit III.C. of the August 12, 2019, rulemaking.
    From non-dietary exposure. Since there are no new residential uses 
proposed under this petition, the prior residential assessment is 
unchanged, and no risks of concern were identified. The summary can be 
found in Unit III.C. of the August 12, 2019, rulemaking.
    Cumulative effects from substances with 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 
pydiflumetofen and any other substances and pydiflumetofen does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this action, therefore, EPA has not assumed that 
pydiflumetofen 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 to 1X. See Unit III.D. of 
the August 12, 2019, rulemaking for a discussion of the Agency's 
rationale for that determination.
    Aggregate risk 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 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. Short-, intermediate-, and chronic-term risks are evaluated 
by comparing the estimated aggregate food, water, and residential 
exposure to the appropriate points of departure (PODs) to ensure that 
an adequate MOE exists.
    Acute dietary risks are below the Agency's level of concern of 100% 
of the aPAD; they are 9.1% of the aPAD for children 3 to 5 years 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 30% of the cPAD for children 1 to 2 years old, the 
population subgroup with the highest exposure estimate.
    The short-term aggregate exposure assessment includes dietary (food 
and drinking water) and post-application dermal exposure. The dermal 
routes of exposure used in the aggregate exposure assessment were 
activities in gardens for adults and children 6 to less than 11 years 
old and golfing for youths 11 to less than 16 years old. EPA has 
concluded the combined short-term food, water, and residential 
exposures result in aggregate MOEs of 350 for adults, 560 for children 
6 to less than 11 years old, and 2,400 for youth 11 to less than 16 
years old. Because EPA's level of concern for pydiflumetofen is an MOE 
of 100 or below, these MOEs are not of concern. No intermediate-term 
aggregate exposure scenarios were identified. Acute and chronic 
aggregate risks are equivalent to the dietary (food and drinking water) 
risks for those respective assessments and are not of concern.
    Pydiflumetofen is classified as ``Not Likely to be Carcinogenic to 
Humans'' at doses that do not induce a proliferative response in the 
liver. The chronic reference dose will be protective of all chronic 
toxicity, including carcinogenicity, and is not of concern.
    Determination of safety. Therefore, based on the risk assessments 
and information described above, EPA concludes that there is reasonable 
certainty that no harm will result in the general population, or to 
infants and children, from aggregate exposure to pydiflumetofen 
residues. More detailed information can be found at https://www.regulations.gov in the document titled ``Pydiflumetofen. Human 
Health Risk Assessment for Proposed New Foliar Use on Caneberry 
Subgroup 13-07A and Greenhouse Foliar/Drench Uses on Peppers and 
Greenhouse Foliar Uses on Head/Leaf Lettuce. Proposed New Soil 
Application Use on Cucurbit Vegetables, Crop Group 9; Amended/Increased 
Foliar Use Rate on Peanut; New Seed Treatment Uses on Edible-Podded 
Legume Vegetables Crop Subgroup 6A and Succulent Shelled Pea/Bean Crop 
Subgroup 6B; and Amended/Increased Seed Treatment Use Rate on 
Soybean.'' in docket ID number EPA-HQ-OPP-2021-0446.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the August 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).
    Codex has not established a MRL for residues of pydiflumetofen in/
on caneberry subgroup 13-07A. Codex has established MRLs for residues 
of pydiflumetofen at 0.5 ppm in/on eggplant, ground cherry, pepino, 
pepper (bell and non-bell), tomatillo, and tomato, and at 0.02 ppm in/
on martynia, okra, and roselle. It is not possible to harmonize the 
U.S. tolerance for vegetable, fruiting, group 8-10 (0.60 ppm) with 
these Codex MRLs because decreasing the domestic tolerance could put 
U.S. growers at risk of violative residue levels despite legal use of 
pydiflumetofen according to the label. The already established U.S. 
tolerance is harmonized with the Canadian MRLs for residues of 
pydiflumetofen in/on the individual crops of vegetable, fruiting, group 
8-10.

C. Revisions to Petitioned-for Tolerances

    EPA is establishing a tolerance for Caneberry subgroup 13-07A at 5 
ppm. IR-4 proposed a tolerance of 4 ppm based on combining the residue 
data for the representative commodities (blackberry and raspberry) in 
the Organisation for Economic Cooperation and Development (OECD) 
calculator analysis. EPA's practice is to conduct the OECD calculator 
analysis separately for each representative commodity. For 
pydiflumetofen, the OECD calculator analysis results in a tolerance of 
5 ppm for Caneberry subgroup 13-07A.
    IR-4 also requested an increase in the existing crop group 
tolerance for vegetable, fruiting, group 8-10 from 0.60 ppm to 0.8 ppm, 
based on its calculations entering the four new residue data points 
from the greenhouse bell and non-bell pepper field trials into the OECD 
MRL calculator. EPA's practice is to conduct the OECD calculator 
analysis separately for each representative commodity of a crop group. 
This was not possible because bell pepper and non-bell pepper each have 
two residue data points and the OECD MRL calculator requires a minimum 
of three data points. After considering an alternative approach of 
estimating an appropriate tolerance as well as the maximum residue in 
the submitted greenhouse field trial data, which was 0.480 ppm, EPA 
determined that residues in or on peppers from the proposed new 
greenhouse uses on peppers are expected to be covered by the currently 
established tolerance of 0.60 ppm. This was a minor use joint review 
with Canada's Pest Management

[[Page 9756]]

Regulatory Agency (PMRA); PMRA came to the same conclusion and is 
maintaining its MRL for residues of pydiflumetofen in or on vegetable, 
fruiting, group 8-10 at 0.60 ppm.

V. Conclusion

    Therefore, a tolerance is established for residues of 
pydiflumetofen, (3-(difluoromethyl)-N-methoxy-1-methyl-N-[1-methyl-2-
(2,4,6-trichlorophenyl)ethyl]-1H-pyrazole-4-carboxamide) in or on 
caneberry subgroup 13-07A at 5 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 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: January 24, 2023.
Daniel Rosenblatt,
Acting 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.  180.699, amend paragraph (a) by designating the table as 
table 1 and adding in alphabetical order in newly designated table 1 to 
paragraph (a) the entry ``Caneberry subgroup 13-07A'' to read as 
follows:


Sec.  180.699  Pydiflumetofen; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Caneberry subgroup 13-07A....................................          5
 
                                * * * * *
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[FR Doc. 2023-03210 Filed 2-14-23; 8:45 am]
BILLING CODE 6560-50-P


