[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Rules and Regulations]
[Pages 5409-5415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31823]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0829; FRL-9956-85]


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 multiple commodities which are identified and 
discussed later in this document. Interregional Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective January 18, 2017. Objections and 
requests for hearings must be received on or before March 20, 2017, 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-2015-0829, 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: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

[[Page 5410]]

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-2015-0829 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 
March 20, 2017. 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-2015-0829, 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 May 19, 2016 (81 FR 31581) (FRL-9946-
02), 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 
5E8422) by Interregional Research Project Number 4 (IR-4), Rutgers 
University, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540. The 
petition requested that 40 CFR 180.599 be amended by establishing 
tolerances for residues of the insecticide acequinocyl in or on avocado 
at 0.4 parts per million (ppm); bean, dry, seed at 0.03 ppm; vegetable, 
cucurbit, group 9 at 0.2 ppm; tea, plucked leaves at 40 ppm; cherry 
subgroup 12-12A at 1.0 ppm; fruit, citrus, group 10-10 at 0.20 ppm; 
fruit, pome, group 11-10 at 0.40 ppm; nut, tree, group 14-12 at 0.02 
ppm; and vegetable, fruiting, group 8-10 at 0.70 ppm. The petition also 
requested that upon establishment of the above tolerances, to remove 
the existing tolerances for cucumber at 0.15 ppm; melon, subgroup 9A at 
0.15 ppm; cherry, sweet at 0.50 ppm; cherry, tart at 1.0 ppm; fruit, 
citrus, group 10 at 0.20 ppm; fruit, pome, group 11 at 0.40 ppm; nut, 
tree, group 14 at 0.02 ppm; pistachio at 0.02 ppm; vegetable, fruiting, 
group 8 at 0.70 ppm; and okra at 0.70 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. Comments 
were received on the notice of filing. EPA's response to these comments 
is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which some of the tolerances are being 
established. The reason for these changes is explained in Unit IV.D.

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 and immunotoxicity and there was no evidence 
of carcinogenic potential in either the rat or mouse, or in the 
genotoxicity and mutagenicity studies.
    In rats and rabbits, there was no evidence of increased 
quantitative or qualitative fetal susceptibility. In both species there 
were clinical signs and gross necropsy findings seen in maternal 
animals at similar or lower doses than those producing resorptions. In 
rabbits, there were increased incidences of late resorptions at the 
highest dose tested. In the rat two-generation reproductive toxicity 
study, there was evidence of apparent increased quantitative postnatal 
susceptibility. Offspring effects at the mid- and high-doses consisted 
of swollen body parts, protruding eyes, clinical signs, delays in pupil 
development, and increased mortality occurring mainly after weaning. No 
parental effects were observed up to the highest dose tested; however, 
hematological parameters, such as changes in partial and activated 
partial

[[Page 5411]]

thromboplastin times, were not measured in parental animals and changes 
in these parameters would have been expected at the same doses as 
offspring effects based on rat studies in the acequinocyl toxicological 
database. 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 Dry Beans, Cucurbit Vegetables, Group 9, Avocado and Tea (Without 
U.S. Registration) and Crop Group Conversions for Citrus Fruit Group 
10-10, Tree Nut Group 14-12, and Fruiting Vegetable Group 8-10'' at 
page 30 in docket ID number EPA-HQ-OPP-2015-0829.

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.
    Since the last assessment for acequinocyl (Federal Register of 
April 13, 2016, (81 FR 21752) (FRL-9944-34)), the endpoints for 
acequinocyl were revisited and updated based upon the available data. 
An acute dietary endpoint for the general population has been selected 
to be consistent with current Agency practices. A summary of the 
updated toxicological endpoints for acequinocyl used for human risk 
assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Acequinocyl for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 7.3 mg/kg/    Acute RfD = 0.073    Reproduction and fertility effects
 including infants and children).   day UFA = 10x.        mg/kg/day.           in rats Offspring LOAEL (M/F) =
                                   UFH = 10x...........  aPAD = 0.073 mg/kg/   58.9 based on hemorrhagic
                                   FQPA SF = 1x........   day.                 effects, swollen body parts,
                                                                               protruding eyes, clinical signs,
                                                                               delays in pupil development and
                                                                               increased mortality post weaning.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 2.7 mg/kg/    Chronic RfD = 0.027  18-month carcinogenicity study in
                                    day UFA = 10x.        mg/kg/day.           mice; LOAEL = 7.0 mg/kg/day based
                                   UFH = 10x...........  cPAD = 0.027 mg/kg/   on clinical chemistry and
                                   FQPA SF = 1x........   day.                 microscopic non-neoplastic
                                                                               lesions (brown pigmented cells
                                                                               and perivascular inflammatory
                                                                               cells in liver).
Dermal short-term (1 to 30 days).  Dermal study NOAEL =  LOC for MOE = 100..  28-dermal toxicity in rats.
                                    200 mg/kg/day.                            LOAEL (M/F) = 1000 mg/kg/day based
                                   UFA = 10x...........                        on increased clotting factor
                                   UFH = 10x...........                        times in males.
                                   FQPA SF = 1x........
Cancer (Oral, dermal, inhalation)  Classification: Not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

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,

[[Page 5412]]

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 [gteqt]3.6 x 
10-3 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 6.69 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 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: There is a potential for residential 
exposure associated with handler (i.e., mixing, loading and applying); 
however, 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). Therefore, the 
Agency has made the assumption that these products are not for 
homeowner use, and has not conducted a quantitative residential handler 
assessment.
    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 Web site 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 FQPA Safety 
Factor (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, but the concern is low since: (1) The effects in pups are well 
characterized with a clear NOAEL; and (2) the effects are protected for 
by the selected endpoints. Therefore, there are no residual 
uncertainties for pre-/post-natal toxicity. Additionally, taking into 
consideration the full database, there would be no susceptibility to 
offspring since assessment of parental animals in the two-generation 
reproductive toxicity study were limited. If additional evaluations had 
been performed, including all hematological measurements, then it would 
be expected that effects on the hematopoietic system observed in the 
other oral rat studies would have been seen at the same doses eliciting 
offspring effects. Therefore, using a weight-of-evidence approach that 
puts the offspring findings in the two-generation reproductive toxicity 
study in context with the full toxicological database, there is no 
concern for susceptibility to offspring 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

[[Page 5413]]

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 70% 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 1200 for adults 
and 890 for children 6-12 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).
    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 and Meth-135) 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.

C. Response to Comments

    A comment was submitted by the Center for Biological Diversity and 
was primarily concerned about EPA's consideration of the impacts of 
acequinocyl on the environment, pollinators, and endangered species. 
This comment is not relevant to the Agency's evaluation of safety of 
the acequinocyl tolerances under section 408 of the FFDCA, which 
requires the Agency to evaluate the potential harms to human health, 
not effects on the environment.
    Two other comments were submitted in response to the Notice of 
Filing that stated, in part, that this chemical ``should not be used at 
all in America or anywhere in the world'' and that ``no residue should 
be permitted on any food or other plant.'' The Agency understands the 
commenter's concerns and recognizes that some individuals believe that 
pesticides should be banned on agricultural crops. However, the 
existing legal framework provided by section 408 of the FFDCA states 
that tolerances may be set when persons seeking such tolerances or 
exemptions have demonstrated that the pesticide meets the safety 
standard imposed by that statute. The citizens' comments appear to be 
directed at the underlying statute and not EPA's implementation of it; 
the citizens have made no contention that EPA has acted in violation of 
the statutory framework.

D. Revisions to Petitioned-For Tolerances

    The petitioned-for tolerance of 0.4 for residues on avocado is 
being increased to 0.50 ppm as EPA corrected some residue levels in the 
field trials for degradation during storage and declared two of the 
trials to be replicates. The

[[Page 5414]]

data that EPA used in Organization for Economic Co-operation and 
Development (OECD) Maximum Residue Limits (MRL) Tolerance Worksheet for 
avocado was thus slightly different from the petitioner's data. The 
tolerance level of 0.15 ppm for residues in dry beans is based upon the 
OECD MRL tolerance worksheet. The difference is based on EPA using 
slightly different residue levels that were corrected for degradation 
during storage. The tolerance level of 0.30 ppm for residues in/on 
cucurbit vegetables is based upon the OECD MRL tolerance worksheet. The 
difference is based on EPA using slightly different residue levels that 
were corrected for degradation during storage. The data that EPA used 
in MRL tolerance spreadsheet for summer squash was slightly different 
from the petitioner's data. Concerning the crop group conversions, the 
tolerance level for residues in/on citrus fruit was modified to be 
harmonized with the Canadian MRL.

V. Conclusion

    Therefore, tolerances are established for residues of acequinocyl, 
including its metabolites and degradates, in or on avocado at 0.50 ppm; 
bean, dry, seed at 0.15 ppm; cherry, subgroup 12-12A at 1.0 ppm; fruit, 
citrus, group 10-10 at 0.35 ppm; fruit, pome, group 11-10 at 0.40 ppm; 
nut, tree, group 14-12 at 0.02 ppm; tea, plucked leaves at 40 ppm; 
vegetable, cucurbit, group 9 at 0.30 ppm; and vegetable, fruiting, 
group 8-10 at 0.70 ppm. In addition, the existing tolerances on cherry, 
sweet; cherry, tart; cucumber; fruit, citrus, group 10; fruit, pome, 
group 11; melon, subgroup 9A; nut, tree, group 14; okra; pistachio; and 
vegetable, fruiting, group 8 are removed as unnecessary since they are 
now covered by the new tolerances.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the 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: December 15, 2016.
Daniel J. Rosenblatt,
Acting 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, in the table in paragraph (a);
0
a. Add alphabetically the entries ``Avocado''; ``Bean, dry, seed''; 
``Cherry, subgroup 12-12A''; ``Fruit, citrus, group 10-10''; ``Fruit, 
pome, group 11-10''; ``Nut, tree, group 14-12''; ``Tea, plucked 
leaves'' (and a footnote); ``Vegetable, cucurbit, group 9''; and 
``Vegetable, fruiting, group 8-10''; and
0
b. Remove the entries for ``cherry, sweet''; ``cherry, tart''; 
``cucumber''; ``fruit, citrus, group 10''; ``fruit, pome, group 11''; 
``melon, subgroup 9A''; ``nut, tree, group 14''; ``okra''; 
``pistachio''; and ``vegetable, fruiting, group 8'' from the table in 
paragraph (a).
    The additions read as follows:


Sec.  180.599   Acequinocyl; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                 * * * *
Avocado....................................................         0.50
Bean, dry, seed............................................         0.15
 
                                 * * * *
Cherry, subgroup 12-12A....................................          1.0
 
                                 * * * *
Fruit, citrus, group 10-10.................................         0.35
Fruit, pome, group 11-10...................................         0.40
 
                                 * * * *
Nut, tree, group 14-12.....................................         0.02
 
                                 * * * *
Tea, plucked leaves \1\....................................           40
Vegetable, cucurbit, group 9...............................         0.30
Vegetable, fruiting, group 8-10............................         0.70
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of January 18, 2017 for use on
  tea.


[[Page 5415]]

* * * * *
[FR Doc. 2016-31823 Filed 1-17-17; 8:45 am]
 BILLING CODE 6560-50-P