[Federal Register Volume 86, Number 65 (Wednesday, April 7, 2021)]
[Rules and Regulations]
[Pages 17917-17920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07129]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0531; FRL-10017-27]


Penthiopyrad; Pesticide Tolerance

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 persimmon. Mitsui Chemicals Agro, Inc., c/o 
Landis International, Inc. requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 7, 2021. Objections and 
requests for hearings must be received on or before June 7, 2021, 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-2019-0531, is available at http://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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; 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 Government 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

[[Page 17918]]

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-2019-0531 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 7, 2021. 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-2019-0531, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 24, 2020 (85 FR 37806) (FRL-10010-
82), 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 
9E8773) by Mitsui Chemicals Agro, Inc. \c/o\ Landis International, 
Inc., 3185 Madison Highway, P.O. Box 5126, Valdosta, GA 31603-5126. The 
petition requested that 40 CFR 180.658 be amended by establishing 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 persimmon, at 3.0 parts per million (ppm). That 
document referenced a summary of the petition prepared by Mitsui 
Chemicals Agro, Inc. \c/o\ Landis International, Inc., the registrant, 
which is available in the docket for this action, docket ID number EPA-
HQ-OPP-2019-0531, at http://www.regulations.gov. There were no comments 
received in response to the notice of filing. EPA is setting a 
tolerance of 3 ppm in persimmon, instead of the petitioner-proposed 
tolerance value of 3.0 ppm. This change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

A. Statutory Background

    Section 408(b)(2)(A)(i) of the 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 penthiopyrad, including exposure resulting from 
the tolerance established by this action. EPA's assessment of exposures 
and risks associated with penthiopyrad follows.

B. Aggregate Risk Assessment

    In an effort to streamline Federal Register publications, EPA is 
directing readers to certain sections of Federal Register notifications 
for previous tolerance rulemakings for the same pesticide that contain 
information that has not changed in the current risk assessment. To 
that end, on June 6, 2019, EPA published in the Federal Register a 
final rule establishing a tolerance for residues of penthiopyrad in or 
on multiple commodities based on the Agency's conclusion that aggregate 
exposure to penthiopyrad is safe for the general population, including 
infants and children. See 84 FR 26352 (FRL-9994-08). Please refer to 
the following sections of the previous tolerance rulemaking that 
contain information that has remained the same under the current risk 
assessment for this rulemaking: Units III.A (Toxicological Profile); 
III.B (Toxicological Points of Departure/Levels of Concern); III.C 
(Exposure Assessment), except as explained in the next paragraph; and 
III.D (Safety Factor for Infants and Children).
    Updates to exposure assessment. The Agency conducted an updated 
risk assessment to evaluate exposure to residues of penthiopyrad on 
persimmon. EPA's acute and chronic dietary (food and drinking water) 
exposure assessments have been updated to include the additional 
exposure from use of penthiopyrad on persimmon. As to residue levels in 
food, the dietary exposure assessments are based on tolerance-level 
residues and assumed 100 percent crop treated (PCT). There will be no 
U.S. registrations for use of penthiopyrad on persimmon, and there is 
no proposed new residential use. Therefore, EPA's assessments of 
dietary exposure from drinking water and non-dietary (i.e., 
residential) exposure, as well as cancer classification and cumulative 
effects from substances with a common mechanism of toxicity, have not 
changed and are described in the previous tolerance rulemaking.
    Assessment of aggregate risks. Acute aggregate risk estimates are 
equal to acute dietary (food and drinking water) risk estimates, which 
are below the Agency's level of concern of 100% of the acute population 
adjusted dose (aPAD): The exposure estimate is 20% of the aPAD at the 
95th percentile of exposure for infants less than 1 year old, which is 
the population subgroup with the highest exposure estimate. Chronic 
aggregate risk estimates are equal to chronic dietary (food and 
drinking water) risk estimates, which are below

[[Page 17919]]

the Agency's level of concern of 100% of the chronic population 
adjusted does (cPAD): The exposure estimate is 28% of the cPAD for 
infants less than 1 year old, which is the population subgroup with the 
highest exposure estimate. Short-term aggregate risk estimates are 
equal to the most conservative residential exposure estimates plus 
chronic dietary exposure estimates (considered to be background dietary 
exposure). For adults, the most conservative residential exposure 
estimate is dermal exposure through high contact lawn activity, with a 
margin of exposure (MOE) above the Agency's level of concern of 100 
(MOE = 560). For children, the most conservative residential exposure 
estimate is combined dermal and incidental oral exposure through high 
contact lawn activity, with an MOE above the Agency's level of concern 
of 100 (MOE = 270). Moreover, the children 1 to less than 2 years old 
population subgroup was chosen for the short-term aggregate risk 
estimate for children, since the exposure estimate for this subgroup is 
protective for all other children subpopulations. Considering both the 
chronic dietary (food and drinking water) exposures and the high 
contact lawn activity residential exposures for both adults and 
children, EPA has concluded the short-term aggregate MOEs are 440 and 
220 for adults and children, respectively, which are above the level of 
concern of 100 and therefore are not of concern.

C. Determination of Safety

    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 penthiopyrad residues. More detailed information 
on the subject action to establish a tolerance in or on persimmon can 
be found in the document entitled, ``Penthiopyrad. Human Health Risk 
Assessment for the Proposed Tolerance Without a U.S. Registration on 
Persimmon.'' dated 12/14/2020 at www.regulations.gov, under docket ID 
number EPA-HQ-OPP-2019-0531.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a liquid chromatography-tandem 
mass spectrometry (LC/MS/MS) method known as Method CEM 3399-001) is 
available to enforce penthiopyrad tolerances. 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). Codex is a joint United Nations Food and Agriculture 
Organization/World Health Organization food standards program, and it 
is recognized as an international food safety standards-setting 
organization in trade agreements to which the United States is a party. 
EPA may establish a tolerance that is different from a Codex MRL; 
however, FFDCA section 408(b)(4) requires that EPA explain the reasons 
for departing from the Codex level.
    The established Codex MRL for penthiopyrad in persimmons is 0.4 mg/
kg. The 3 ppm tolerance being established is harmonized with the 
existing Japanese MRL of 3 ppm instead, which is consistent with the 
tolerance value requested by the petitioner. According to the 
registrant, the locations of the field trials for residue data reflect 
the primary importation of persimmon from Japan. The registrant cited 
USDA Economic Research Service data indicating that Spain, Israel, and 
Chile are the only countries with >5% imports of persimmons into the 
United States. The registrant indicated that penthiopyrad is registered 
in Spain and Israel but not on persimmon and that penthiopyrad is not 
registered in Chile. Therefore, the registrant posits that the only 
importing country on which penthiopyrad would be registered for use on 
persimmon would be Japan.

C. Revisions to Petitioned-For Tolerances

    The Agency is setting a tolerance in or on persimmon of 3 ppm 
rather than the petitioned-for tolerance value of 3.0 ppm. This value 
is in accordance with the Organization for Economic Cooperation and 
Development (OECD) MRL calculation procedure's rounding class 
practices.

V. Conclusion

    Therefore, tolerances are established for residues of penthiopyrad 
(N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-
pyrazole-4-carboxamide) in or on persimmon 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 Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). 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 for 
residues 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

[[Page 17920]]

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: March 16, 2021.
Marietta Echeverria,
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.  180.658, amend paragraph (a)(1) by designating the table 
and adding in alphabetical order in newly designated Table 1 to 
paragraph (a)(1) the entry ``Persimmon'' and footnote 2 to read as 
follows:


Sec.  180.658  Penthiopyrad; tolerances for residues.

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

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Persimmon \2\..............................................           3
 
                                * * * * *
 
                                * * * * *
------------------------------------------------------------------------
\2\ There are no U.S. registrations for this commodity as of April 7,
  2021.

* * * * *
[FR Doc. 2021-07129 Filed 4-6-21; 8:45 am]
BILLING CODE 6560-50-P