83 FR 26369 - Acequinocyl; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 110 (June 7, 2018)

This regulation establishes tolerances for residues of acequinocyl in or on guava and the tropical and subtropical, small fruit, inedible peel, subgroup 24A. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Rules and Regulations]
[Pages 26369-26374]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12297]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0376; FRL-9978-20]


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 guava and the tropical and subtropical, small 
fruit, inedible peel, subgroup 24A. Interregional Research Project 
Number 4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective June 7, 2018. Objections and 
requests for hearings must be received on or before August 6, 2018, 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-2017-0376, 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

[[Page 26370]]

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 
Printing 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-2017-0376 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 
August 6, 2018. 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-2017-0376, 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 October 23, 2017 (82 FR 49020) (FRL-
9967-37), 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 
7E8579) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the insecticide acequinocyl, 2-
(acetyloxy)-3-dodecyl-1,4-naphthalenedione, and its metabolite, 2-
dodecyl-3-hydroxy-1,4-naphthoquinone (acequinocyl-OH), expressed as 
acequinocyl equivalents in or on guava at 0.9 ppm and the tropical and 
subtropical, small fruit, inedible peel, subgroup 24A at 2 ppm. That 
document referenced a summary of the petition prepared by Arysta 
LifeScience, the registrant, which is available in the docket, http://www.regulations.gov. A comment expressing concern about the effects of 
wind turbines on bats was received on the notice of filing, but it is 
not relevant to this action.
    EPA is establishing the requested tolerances with additional 
significant figures in conformity with Agency policy.

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 tolerances established by this action. EPA's 
assessment of exposures and risks associated with acequinocyl follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The target organs of acequinocyl are the liver (hepatocyte 
vacuolization, brown pigmented cells and perivascular inflammatory 
cells in liver) and hematopoietic system (hemorrhage, increased 
clotting factor times and increased platelet counts). There was no 
evidence of neurotoxicity or immunotoxicity. There was no evidence of 
carcinogenic potential in either the rat or mouse and there was no 
concern for genotoxicity or mutagenicity.
    In rats and rabbits, there was no evidence of increased 
quantitative or qualitative fetal susceptibility. For both species, 
maternal effects (clinical signs and gross necropsy findings) were 
observed at similar or lower doses than those producing fetal effects. 
In rabbits, there were increased incidences of late resorptions at the 
highest dose tested. Since it is unknown whether resorptions occurred 
from toxicity to maternal animals or the fetuses, the resorptions are 
considered maternal and developmental adverse effects. In the rat

[[Page 26371]]

two-generation reproduction toxicity study, there was increased 
quantitative offspring susceptibility. Offspring effects consisted of 
hemorrhagic effects, swollen body parts (head and extremities), 
protruding eyes, clinical signs (bloody encrusted nose, cold to touch, 
red urine, blue colored eyes and extremities, paleness), delays in 
pupil development, and increased mortality occurring mainly after 
weaning. The increased incidences of hemorrhagic effects post-weaning 
indicate toxicity to the hematopoietic system. While there were no 
parental effects up to the highest dose tested, hematological effects 
(changes in partial and activated partial thromboplastin times) were 
observed in adult animals in other studies at the same dose causing the 
offspring effects, but were not measured in the two-generation 
reproduction toxicity study. As a result, using a weight-of-evidence 
approach that considers the findings from the two-generation 
reproduction toxicity study in context of the full toxicological 
database, parental toxicity would be anticipated at the same doses as 
offspring effects if additional evaluations had been performed, 
particularly hematological measurements. There were no effects on 
reproductive parameters.
    Specific information on the studies received and the nature of the 
adverse effects caused by acequinocyl as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies 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'' on page numbers 29-31 in docket ID number EPA-HQ-OPP-
2017-0376.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for acequinocyl used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of January 18, 2017 (82 FR 5409) 
(FRL-9956-85).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to acequinocyl, EPA considered exposure under the petitioned-
for tolerances as well as all existing acequinocyl tolerances in 40 CFR 
180.599. EPA assessed dietary exposures from acequinocyl in food as 
follows:?>
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for acequinocyl. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) 2003-2008 National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
As to residue levels in food, EPA assumed tolerance-level residues and 
100 percent crop treated (PCT) for all proposed and registered uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance-level 
residues and 100 PCT for all proposed and registered uses.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that acequinocyl does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
acequinocyl. Tolerance-level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for acequinocyl in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of acequinocyl. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS), Provisional Cranberry Model, and Screening 
Concentration in Ground Water (SCI-GROW) Model, the estimated drinking 
water concentrations (EDWCs) of acequinocyl for acute exposures are 
estimated to be 6.69 parts per billion (ppb) for surface water and 3.6 
x 10-3 ppb for ground water, and for chronic exposures are 
estimated to be 6.69 ppb for surface water and 3.6 x 10-3 
ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For both the acute and chronic 
dietary risk assessments, the water concentration value of 6.69 ppb was 
used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Acequinocyl is currently registered for the following uses that 
could result in residential exposures: Use on ornamentals for 
landscapes, gardens, and trees. EPA assessed residential exposure using 
the following assumptions: Residential handler exposures are not 
expected since all registered acequinocyl product labels with 
residential use sites (e.g., ornamentals for landscapes, gardens, and 
trees) require that handlers wear specific clothing (e.g., long-sleeve 
shirt/long pants) and/or use personal protective equipment (PPE). As a 
result, a residential handler assessment was not conducted.

[[Page 26372]]

    Only short-term post-application dermal exposure is anticipated for 
the registered residential uses. The quantitative exposure/risk 
assessment for residential post-application exposures assessed dermal 
exposures to adults for activities associated with gardening, dermal 
exposures to children (6 to <11 years old) for activities associated 
with playing in and around gardens and gardening, dermal exposures to 
adults associated with handling trees and retail plants, and dermal 
exposures to children (6 to <11 years old) for activities associated 
with playing in and around trees and retail plants.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. 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.''
    EPA has not found acequinocyl to share a common mechanism of 
toxicity with any other substances, and acequinocyl does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
acequinocyl does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of an 
increased quantitative or qualitative fetal susceptibility in rats or 
rabbits. In isolation, there was evidence of increased quantitative 
offspring susceptibility in the two-generation reproductive study; 
however, the concern is low since:
    i. The effects in pups are well characterized with a clear NOAEL 
and
    ii. The effects are protected for by the selected endpoints.
    Therefore, there are no residual uncertainties for pre-/post-natal 
toxicity. Additionally, hematological parameters were not measured for 
the parental animals in the two-generation reproductive study; however, 
hematological effects were observed in adult animals in other oral rat 
studies at the same doses eliciting offspring effects. Therefore, 
considering the offspring findings in the two-generation reproductive 
toxicity study in context with the full toxicological database, there 
is no concern for offspring susceptibility since parental toxicity 
would be anticipated at the same dose as offspring effects.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for acequinocyl is complete.?>
    ii. There is no indication that acequinocyl is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence of an increased quantitative or 
qualitative fetal susceptibility in rats or rabbits, but in isolation 
there was evidence of increased quantitative offspring susceptibility 
in the two-generation reproductive study. However, the concern is low 
for the reasons outlined above in section III.D.2.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to acequinocyl in drinking water. EPA used similarly 
conservative assumptions to assess post-application exposure of 
children. These assessments will not underestimate the exposure and 
risks posed by acequinocyl.

E. 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 PAD (aPAD) and chronic PAD (cPAD). 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 PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to acequinocyl will occupy 71% of the aPAD for children 1-2 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
acequinocyl from food and water will utilize 71% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
acequinocyl is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Acequinocyl 
is currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to acequinocyl.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 1140 for adults 
and 910 for children 6-11 years old. Because EPA's level of concern for 
acequinocyl is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).

[[Page 26373]]

    An intermediate-term adverse effect was identified; however, 
acequinocyl is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
acequinocyl.
    5. Aggregate cancer risk for U.S. population. 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.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that 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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (two high-performance liquid 
chromatography methods with tandem mass-spectroscopy detection (HPLC/
MS/MS) for determining residues in/on fruit and nut commodities (Morse 
Methods Meth-133, Revision #4 and Meth-135, Revision #3)) is available 
to enforce the tolerance expression.
    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). 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 EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established any MRLs for acequinocyl on the crops 
cited in this document.?>

V. Conclusion

    Therefore, tolerances are established for residues of acequinocyl, 
including its metabolites and degradates, in or on guava at 0.90 ppm 
and the tropical and subtropical, small fruit, inedible peel, subgroup 
24A at 2.0 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), 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: May 25, 2018.
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, add alphabetically the entries ``Guava'' and 
``Tropical and subtropical, small fruit, inedible peel,

[[Page 26374]]

subgroup 24A'' to the table in paragraph (a) to read as follows:


Sec.  180.599  Acequinocyl; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Guava.......................................................        0.90
 
                                * * * * *
Tropical and subtropical, small fruit, inedible peel,                2.0
 subgroup 24A...............................................
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-12297 Filed 6-6-18; 8:45 am]
BILLING CODE 6560-50-P