[Federal Register Volume 85, Number 95 (Friday, May 15, 2020)]
[Rules and Regulations]
[Pages 29338-29340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09451]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0387; FRL-10007-38]


Acequinocyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
acequinocyl in or on the bushberry subgroup 13-07B. Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 15, 2020. Objections and 
requests for hearings must be received on or before July 14, 2020, 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-2019-0387, 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: Michael Goodis, 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: RDFRNotices@epa.gov.

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.

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-2019-0387 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 
July 14, 2020. 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-2019-0387, 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. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 30, 2019 (84 FR 45702) (FRL-9998-
15),

[[Page 29339]]

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 9E8768) 
by IR-4, IR-4 Project Headquarters, Rutgers, The State University of 
New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. 
The petition requested that 40 CFR part 180 be amended by establishing 
a tolerance for residues of acequinocyl, 2-(acetyloxy)-3-dodecyl-
1,4,naphthalenedione and its metabolite 2-dodecyl-3-hydroxy-1,4-
naphthoquinone expressed as acequinocyl equivalents in or on the 
bushberry subgroup 13-07B at 3 parts per million (ppm). That document 
referenced a summary of the petition prepared by Arysta LifeScience 
North America Corporation, the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.

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 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 acequinocyl including exposure 
resulting from the tolerance established by this action. EPA's 
assessment of exposures and risks associated with acequinocyl follows.
    On June 7, 2018, EPA published in the Federal Register a final rule 
establishing tolerances for residues of acequinocyl in or on guava and 
the tropical and subtropical, small fruit, inedible peel, subgroup 24A 
based on the Agency's conclusion that aggregate exposure to acequinocyl 
is safe for the general population, including infants and children. See 
(83 FR 26369) (FRL-9978-20). That document contains a summary of the 
toxicological profile and points of departure, assumptions for exposure 
assessment, and the Agency's determination regarding the children's 
safety factor, which have not changed.
    EPA's exposure assessments have been updated to include the 
additional exposure from use of acequinocyl on the bushberry subgroup 
13-07B, i.e., reliance on tolerance-level residues and an assumption of 
100 percent crop treated (PCT). EPA's aggregate exposure assessment 
incorporated this additional dietary exposure, as well as exposure in 
drinking water and from residential sources, although those latter 
exposures are not impacted by the new use on the bushberry subgroup 13-
07B and thus have not changed since the last assessment. Further 
information about EPA's risk assessment and determination of safety 
supporting the tolerances established in the June 7, 2018 Federal 
Register action, as well as the new acequinocyl tolerance can be found 
at http://www.regulations.gov in the document titled ``Acequinocyl. 
Human Health Risk Assessment to Support the Petition for Tolerance for 
Residues in/on Guava and Tropical and Subtropical, Small Fruit, 
Inedible Peel, Subgroup 24A.'' dated May 16, 2018, in docket ID EPA-HQ-
OPP-2017-0376 and the document titled, ``Acequinocyl. Human Health Risk 
Assessment to Support the Petition for Tolerance for Residues in/on the 
Bushberry Subgroup 13-07B'' in docket ID number EPA-HQ-OPP-2019-0387.
    Acute dietary risks are below the Agency's level of concern: 58% of 
the acute population adjusted dose (aPAD) for children 1 to 2 years 
old, the population group of concern. Chronic dietary risks are below 
the Agency's level of concern: 54% of the chronic population adjusted 
dose (cPAD) for children 1 to 2 years old, the group with the highest 
exposure. There is not expected to be any residential handler exposure, 
and only post-application dermal exposures are expected from registered 
uses of acequinocyl in residential areas. Residential post-application 
oral and inhalation exposures are not expected. Using the exposure 
assumptions described for short-term exposures, EPA has concluded the 
combined short-term food, water, and residential exposures result in 
aggregate MOEs above the LOC of 100 for all scenarios assessed and are 
not of concern.
    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 acequinocyl residues. More detailed information 
on the subject action to establish a tolerance in or on the Bushberry 
subgroup 13-07B can be found in the document entitled, ``Acequinocyl. 
Human Health Risk Assessment to Support the Petition for Tolerance for 
Residues in/on the Bushberry Subgroup 13-07B'' by going to http://www.regulations.gov. The referenced document is available in the docket 
established by this action, which is described under ADDRESSES. Locate 
and click on the hyperlink for docket ID number EPA-HQ-OPP-2019-0387.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There are adequate residue analytical methods for enforcing 
tolerances for acequinocyl residues of concern in/on the registered 
plant and livestock commodities. These methods include two high-
performance liquid chromatography methods with tandem mass-spectroscopy 
detection (HPLC/MS/MS) for determining residues in/on fruit and nut 
crops and livestock matrices.
    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: 
residuemethods@epa.gov.

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 Alimentarius 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

[[Page 29340]]

EPA explain the reasons for departing from the Codex level.
    The Codex has not established a MRL for acequinocyl in or on the 
bushberry subgroup 13-07B.

V. Conclusion

    Therefore, a tolerance is established for residues of acequinocyl, 
including its metabolites and degradates in or on the bushberry 
subgroup 13-07B 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 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: April 1, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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.  180.599, amend the table in paragraph (a) by adding in 
alphabetical order an entry for ``Bushberry subgroup 13-07B'' to read 
as follows:


Sec.  180.599  Acequinocyl; tolerances for residues.

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------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
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                                * * * * *
Bushberry subgroup 13-07B...............................               3
 
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[FR Doc. 2020-09451 Filed 5-14-20; 8:45 am]
 BILLING CODE 6560-50-P


