[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Rules and Regulations]
[Pages 48507-48511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18716]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0475; FRL-8763-01-OCSPP]


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 tropical and subtropical, medium to large fruit, 
smooth, inedible peel subgroup 24B. The Interregional Project Number 4 
(IR-4) requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 31, 2021. Objections and 
requests for hearings must be received on or before November 1, 2021, 
and must be filed in accordance with the

[[Page 48508]]

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-2020-0475, 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.
    Due to the public health concerns relating to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide customer service via 
email, phone, and webform. For the latest status information on EPA/DC 
services, docket access, visit http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director, 
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.

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-2020-0475 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 
November 1, 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-2020-0475, 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/where-send-comments-epa-dockets.
    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 December 21, 2020 (85 FR 82998) (FRL-
10016-93), 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 
0E8860) by IR-4, Rutgers, The State University of New Jersey, 500 
College Road East, Suite 201W, Princeton, NJ 08540. The petition 
requested that 40 CFR 180.599 be amended by establishing a tolerance 
for the residue of the miticide acequinocyl [2-(acetyloxy)-3-dodecyl-
1,4-naphthalenedione] and its metabolite acequinocyl-OH [2-dodecyl-3-
hydroxy-1,4-naphthoquinone], expressed as acequinocyl, in or on 
tropical and subtropical, medium to large fruit, smooth, inedible peel 
subgroup 24B at 7 parts per million (ppm). That document referenced a 
summary of the petition prepared by IR-4, the petitioner, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA is 
establishing the tolerance for the tropical and subtropical, medium to 
large fruit, smooth, inedible peel subgroup 24B at 4 ppm. 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. . . 
.''
    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.

[[Page 48509]]

    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 
acequinocyl, in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to acequinocyl 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 acequinocyl, see Unit III.A. of the June 7, 2018 rulemaking 
(83 FR 26369) (FRL-9978-20).
    Toxicological Points of Departure/Levels of Concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern for 
acequinocyl used for human risk assessment, please reference Unit 
III.B. of the January 18, 2017 rulemaking (82 FR 5409) (FRL-9956-85).
    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 
7, 2018 rulemaking.
    EPA's dietary exposure assessments have been updated to include the 
additional exposure from the new use of acequinocyl on the commodities 
in tropical and subtropical, medium to large fruit, smooth, inedible 
peel subgroup 24B. The assessment used the same assumptions as the June 
7, 2018 final rule concerning tolerance-level residues, default 
processing factors for all processed commodities and 100 percent crop 
treated.
    Drinking water exposure. EPA has revised the acequinocyl drinking 
water assessment since the June 7, 2018 rulemaking to reflect the water 
solubility limits of acequinocyl and its hydroxylated degradate 
acequinocyl-OH (R1) due to uncertainty in the environmental fate study 
data. The recommended acute estimated drinking water concentration 
(EDWC) is 21 parts per billion (ppb) based on the water solubility 
limits of acequinocyl and acequinocyl-OH added together. The 
recommended chronic EDWC is 14 ppb, which is the maximum amount of 
acequinocyl residues of concern that may be present over a year. This 
level is based on the solubility of the degradate acequinocyl-OH (R1), 
which persists over the chronic exposure period.
    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., ornamentals for landscapes, gardens, and trees) has not 
changed since the June 7, 2018 rulemaking.
    Cumulative exposure. 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 
acequinocyl and any other substances and acequinocyl does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this action, therefore, EPA has not assumed that 
acequinocyl 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. See Unit III.D. of the 
June 7, 2018 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 
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.
    Acute dietary risks are below the Agency's level of concern of 100% 
of the aPAD; they are 96% of the aPAD for children 1 to 2 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 90% of the cPAD for children 1 to 2 years old, the 
population subgroup with the highest exposure estimate.
    As explained in the June 7, 2018 rulemaking, the Agency has assumed 
that there will be no residential handler exposure; therefore, a 
residential handler assessment was not conducted. The Agency only 
anticipates short-term post-application dermal exposures from 
registered uses of acequinocyl in residential areas. 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 of 1,800 in adults and 1,400 for children 6 to 11 years 
old. Because EPA's level of concern for acequinocyl is an MOE of 100 or 
below, these MOEs are not of concern.
    As stated in the June 7, 2018 rulemaking, acequinocyl is not 
registered for any use patterns that would result in intermediate-term 
residential exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has been assessed under the 
appropriately protective cPAD, EPA relies on the chronic dietary risk 
assessment for evaluating intermediate-term risk for acequinocyl.
    Based on the lack of evidence of carcinogenicity in two adequate 
rodent carcinogenicity studies, acequinocyl is not expected to pose a 
cancer risk to humans.
    Therefore, 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 acequinocyl residues. More detailed information 
can be found at http://www.regulations.gov in the document titled 
``Acequinocyl. Human Health Risk Assessment for the Proposed New Use on 
Tropical and Subtropical, Medium to Large Fruit, Smooth, Inedible Peel 
(Subgroup 24B)'' in docket ID number EPA-HQ-OPP-2020-0475.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the June 7, 2018 rulemaking.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with

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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 acequinocyl 
in/on tropical and subtropical, medium to large fruit, inedible peel, 
subgroup 24B.

C. Revisions to Petitioned-For Tolerances

    FFDCA section 408(d)(4)(A)(i) permits the Agency to finalize a 
tolerance that varies from that sought by the petition. The petitioner 
initially requested a tolerance of 7 ppm for tropical and subtropical, 
medium to large fruit, smooth, inedible peel (crop subgroup 24B). 
However, upon review of the requested tolerance, the Agency noticed 
that the petitioner incorrectly calculated the residues for whole 
fruit. Whole fruit residues were calculated as the sum of residues for 
pulp and peel combined and did not account for total sample weight. 
Residue concentrations are expressed in ppm, which is equivalent to mg/
kg; therefore, residues from pulp and peel cannot simply be combined 
together to determine whole fruit residues without accounting for total 
sample weight. The corrected residue concentrations for the whole fruit 
were approximately half of the initially calculated concentrations and 
produced a recommended tolerance of 4 ppm when entered into the OECD 
calculator.

V. Conclusion

    Therefore, a tolerance is established for residues of acequinocyl, 
including its metabolites and degradates, in or on tropical and 
subtropical, medium to large fruit, smooth, inedible peel subgroup 24B 
at 4 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: August 18, 2021.
Catherine Aubee,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter 1 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.  180.599, amend the table in paragraph (a) by adding a table 
heading and in alphabetical order an entry for ``Tropical and 
subtropical, medium to large fruit, smooth, inedible peel subgroup 
24B'' to read as follows:


Sec.  180.599   Acequinocyl; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Tropical and subtropical, medium to large fruit,                      4
 smooth, inedible peel subgroup 24B....................
 
                              * * * * * * *
------------------------------------------------------------------------


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[FR Doc. 2021-18716 Filed 8-30-21; 8:45 am]
BILLING CODE 6560-50-P