[Federal Register Volume 88, Number 160 (Monday, August 21, 2023)]
[Rules and Regulations]
[Pages 56773-56776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17431]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0235; FRL-10953-01-OCSPP]


Pyraclostrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pyraclostrobin in or on stevia, dried leaves and stevia, fresh leaves 
and revises the tolerance for residues of pyraclostrobin in or on 
coffee, green bean. The Interregional Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective August 21, 2023. Objections and 
requests for hearings must be received on or before October 20, 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-2022-0235, is available 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, please visit 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).

[[Page 56774]]

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-2022-0235 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 
October 20, 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-2022-0235, 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 Tolerances

    In the Federal Register of April 28, 2022 (87 FR 25178) (FRL-9410-
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 
(PP1E8981) by IR-4 Project Headquarters, North Carolina State 
University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 
27606. The petition requested that 40 CFR 180.582 be amended to 
establish tolerances for residues of the fungicide pyraclostrobin, 
(carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy] 
methyl]phenyl]methoxy-, methyl ester) and its desmethoxy metabolite 
(methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl] 
phenylcarbamate), calculated as the stoichiometric equivalent of 
pyraclostrobin in or on the following raw agricultural commodities: 
stevia, dried leaves at 150 parts per million (ppm) and stevia, fresh 
leaves at 40 ppm. The petition also requested the revision of the 
tolerance for residues of pyraclostrobin in or on coffee, green bean at 
0.3 ppm to support the domestic use on coffee rather than being a 
tolerance on coffee imported into the U.S. One comment was received on 
the notice of filing. EPA's response to this comment is discussed 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. . . 
.''
    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 pyraclostrobin including exposure resulting from 
the tolerances established by this action. EPA's assessment of 
exposures and risks associated with pyraclostrobin 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 for the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemakings, and 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 tolerance rulemakings for 
pyraclostrobin in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to pyraclostrobin and established 
tolerances for residues of that chemical. In this rulemaking, EPA is 
incorporating previously published sections from the September 20, 
2021, rulemaking (86 FR 52083) (FRL-8857-01-OCSPP) as described further 
below, as they remain unchanged.
    Toxicological profile. For a discussion of the Toxicological 
Profile of pyraclostrobin, see Unit III.A. of the September 20, 2021, 
rulemaking.
    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern used for the 
human risk assessment, see Unit III.B. of the September 20, 2021, 
rulemaking and pages 11-13 of the document titled ``Pyraclostrobin. 
Human Health Risk Assessment of Proposed Tolerances and Uses on Coffee, 
Green Bean; Stevia, Dried Leaves; and Stevia, Fresh Leaves'' 
(hereinafter ``Pyraclostrobin Human Health Risk Assessment'') in docket 
ID number EPA-HQ-OPP-2022-0235.
    Exposure assessment. Much of the exposure assessment remains the 
same, although updates have occurred to account for 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 
September 20, 2021, rulemaking.
    EPA's dietary exposure assessments have been updated to include the 
additional exposures from the new uses of pyraclostrobin on coffee and 
stevia. In conducting the acute dietary

[[Page 56775]]

exposure assessment, EPA used the Dietary Exposure Evaluation Model 
software with the Food and Commodity Intake Database (DEEM-FCID) 
Version 4.02. This software 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). 
The acute dietary exposure assessment is partially refined, assuming 
tolerance level residues or highest field trial residues and 100 
percent crop treated (PCT) for all crop and livestock commodities.
    The chronic dietary exposure assessment also uses the DEEM-FCID 
Version 4.02 software with the 2005-2010 NHANES/WWEIA data. The chronic 
dietary exposure assessment is refined and uses the same assumptions as 
the Unit III.C.1.ii in the September 20, 2021, rulemaking; 
specifically, anticipated residues based on average field trial residue 
levels for plant raw agricultural commodities or tolerance-level 
residues, PCT information where available, and experimentally 
determined processing factors where available. Anticipated residues for 
livestock commodities were also calculated and incorporated into the 
assessment.
    Anticipated residue and PCT information. For a discussion of the 
FFDCA requirements regarding use of anticipated residue and PCT 
information and the PCT assumptions used in the chronic dietary 
exposure assessment, see Unit III.C.1.iv. of the September 20, 2021, 
rulemaking.
    Drinking water exposure. The new uses do not result in an increase 
in the estimated residue levels in drinking water, so EPA used the same 
estimated drinking water concentrations in the acute and chronic 
dietary exposure assessments as identified in Unit III.C.2. of the 
September 20, 2021, rulemaking.
    Non-occupational exposure. There are no new proposed residential 
(non-occupational) uses expected for pyraclostrobin at this time; 
however, pyraclostrobin is currently registered for uses on turf, 
ornamental, and residential fruit and nut trees that may result in 
residential handler and post-application exposures from commercial and 
residential use. For a summary of those exposures, see Unit III.C.3 of 
the September 20, 2021, rulemaking as it has not changed since then.
    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 pyraclostrobin and any other substances. For 
purposes of this tolerance action, therefore, EPA has not assumed that 
pyraclostrobin 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 September 20, 2021, rulemaking for a discussion of the 
Agency's rationale for that determination as nothing has changed since 
the 2021 rulemaking.
    Aggregate risk 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 aggregate risks are evaluated by comparing the 
estimated total food, water, and residential exposure to the 
appropriate points of departure to ensure that an adequate margin of 
exposure (MOE) exists.
    Acute dietary risks are below the Agency's level of concern of 100% 
of the aPAD; they are 86% of the aPAD for females 13 to 49 years old, 
the only population subgroup for which an acute toxic effect was 
identified. Chronic dietary risks are below the Agency's level of 
concern of 100% of the cPAD; they are 54% of the cPAD for children 1 to 
2 years, the most highly exposed population subgroup.
    EPA determined that it is inappropriate to combine the oral route 
of exposure with dermal and inhalation exposures because of dissimilar 
toxic response observed from exposures to pyraclostrobin via the oral, 
dermal and inhalation routes. Therefore, the short-term aggregate 
exposure assessment includes dietary (food and drinking water) and 
incidental oral hand to mouth exposure from high contact lawn activity 
on treated lawns for children 1 to less than 2 years old. The short-
term aggregate MOE is 260 and is not of concern because it is above the 
Agency's level of concern of 100.
    Pyraclostrobin is classified as ``Not Likely to Be Carcinogenic to 
Humans'' due to an absence of carcinogenicity in the available studies; 
therefore, EPA does not expect pyraclostrobin exposures to pose an 
aggregate cancer risk.
    Therefore, based on the risk assessments and information described 
above, EPA concludes there is a reasonable certainty that no harm will 
result to the general population, or to infants and children, from 
aggregate exposure to pyraclostrobin residues. More detailed 
information on this action can be found in the Pyraclostrobin Human 
Health Risk Assessment in docket ID EPA-HQ-OPP-2022-0235.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method for 
various crops, see Unit IV.A of the September 20, 2021, 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 U.S. tolerance for pyraclostrobin in or on coffee, green bean 
is harmonized with the Codex MRL at 0.3 ppm. There are no Codex MRLs 
for stevia.

C. Response to Comments

    One comment was received in response to the notice of filing, which 
opposed EPA establishing the requested tolerances and objected to the 
use of pesticides on crops. Although the Agency recognizes that some 
individuals believe that pesticides should be banned on agricultural 
crops, the existing legal framework provided by section 408 of the 
FFDCA authorizes EPA to establish tolerances when it determines that 
the tolerance is safe. Upon consideration of the validity, 
completeness, and reliability of the available data as well as other 
factors the FFDCA requires EPA to consider, EPA has determined that 
pyraclostrobin tolerances are safe. The commenter has provided no 
information indicating that a safety determination cannot be supported.

V. Conclusion

    Therefore, tolerances are established for residues of 
pyraclostrobin, (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy] methyl]phenyl]methoxy-, methyl ester) and its desmethoxy 
metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-

[[Page 56776]]

yl]oxy]methyl] phenylcarbamate) in or on stevia, dried leaves at 150 
ppm and stevia, fresh leaves at 40 ppm. The established tolerance for 
residues of pyraclostrobin in or on coffee, green bean at 0.3 ppm is 
revised to remove footnote 1.
    Additionally, EPA is correcting the active ingredient name in the 
introductory paragraph from ``pyradostrobin'' to ``pyraclostrobin''. 
EPA is also removing the Section 18 emergency exemption tolerance for 
residues of pyraclostrobin in or on endive, Belgium at 11.0 ppm as a 
housecleaning measure since that tolerance expired on December 31, 
2013. These changes have no substantive effect and can be accomplished 
without further notice and comment.

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 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 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: August 8, 2023.
Charles Smith,
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.  180.582:
0
a. In paragraph (a)(1):
0
i. In the introductory text,'';
0
ii. Amend the table by adding the heading ``Table 1 to Paragraph 
(a)(1)'';
0
b. In Table 1 to Paragraph (a)(1):
0
i. Revise the entry for ``Coffee, green bean'';
0
ii. Add, in alphabetical order, the entries ``Stevia, dried leaves'' 
and ``Stevia, fresh leaves'';
0
iii. Remove footnote 1 from the end of the table.
0
c. Remove and reserve paragraph (b).
    The additions and revision read as follows:


Sec.  180.582  Pyraclostrobin; tolerances for residues.

    (a) * * *
    (1) Tolerances are established for residues of the fungicide 
pyraclostrobin, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy] methyl]phenyl]methoxy-, methyl ester) and its desmethoxy 
metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl] 
phenylcarbamate), calculated as the stoichiometric equivalent of 
pyraclostrobin, in or on the commodity.

                       Table 1 to Paragraph (a)(1)
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                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Coffee, green bean......................................             0.3
 
                                * * * * *
Stevia, dried leaves....................................             150
Stevia, fresh leaves....................................              40
 
                                * * * * *
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* * * * *
    (b) [Reserved]
* * * * *
[FR Doc. 2023-17431 Filed 8-18-23; 8:45 am]
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