81 FR 21752 - Acequinocyl; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 71 (April 13, 2016)

Page Range		21752-21756
FR Document		2016-08512
This regulation increases an existing tolerance for residues of acequinocyl in or on ``Hop, dried cones.'' Arysta LifeScience requested this tolerance increase under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Federal Register, Volume 81 Issue 71 (Wednesday, April 13, 2016)
[Federal Register Volume 81, Number 71 (Wednesday, April 13, 2016)]
[Rules and Regulations]
[Pages 21752-21756]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08512]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0382; FRL-9944-34]


Acequinocyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation increases an existing tolerance for residues 
of acequinocyl in or on ``Hop, dried cones.'' Arysta LifeScience 
requested this tolerance increase under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective April 13, 2016. Objections and 
requests for hearings must be received on or before June 13, 2016, 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-2015-0382, 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: Susan Lewis, 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 
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-2015-0382 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
June 13, 2016. Addresses for mail and hand delivery of objections and

[[Page 21753]]

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-2015-0382, 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 September 9, 2015 (80 FR 54257) (FRL-
9933-26), 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 
5F8364) by Arysta LifeScience North America Corp., 15401 Weston Pkwy., 
Suite 150, Cary, NC 27513. The petition requested to amend the 
tolerance in 40 CFR 180.599 for residues of the insecticide acequinocyl 
in or on hop, dried cones from 4.0 parts per million (ppm) to 15.0 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. There were no comments received in response to the 
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for acequinocyl including exposure 
resulting from the tolerance established by this action. EPA's 
assessment of exposures and risks associated with acequinocyl follows.

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 absorption, metabolism, distribution, and excretion (ADME) of 
acequinocyl are well characterized. Acequinocyl exhibits marginal 
absorption into the plasma (13-16% for the 10 mg/kg low dose and 8-9% 
for the 500 mg/kg high dose) and relatively rapid and complete 
excretion (24 hours for the low dose and 72 hours for the high dose), 
primarily via the bile and feces (82.6%) in rats. Acequinocyl undergoes 
nearly complete metabolism to hydrolysis products and a glucuronide 
conjugate. There was no evidence for selective tissue accumulation or 
sequestration.
    Across species, durations and routes of exposure (oral and dermal), 
the primary effects in the acequinocyl hazard database are indicative 
of toxicity to 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). In an acute neurotoxicity study, there were no 
effects up to the limit dose (2,000 mg/kg). In a guideline 
immunotoxicity study, there were also no effects up to the highest dose 
tested (45 mg/kg/day). In rats and rabbits, there was no evidence of 
increased quantitative or qualitative fetal susceptibility with 
clinical signs and gross necropsy findings seen in maternal animals at 
similar or lower doses than those producing resorptions. In the rat 2-
generation reproductive toxicity study, 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, however these effects were observed at 
the same doses as parental effects, and a clear NOAEL was established 
which is being used in endpoint selection. There were no effects on 
reproductive parameters. There was no concern for genotoxicity or 
mutagenicity. There was no evidence of carcinogenic potential in either 
the rat or mouse carcinogenicity studies, or in the genotoxicity and 
mutagenicity studies indicating that acequinocyl is ``not likely'' to 
be carcinogenic to humans.
    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 ``May 27, 2015: Acequinocyl. 
Human Health Assessment Scoping Document in Support of Registration 
Review'' on page 15 in docket ID number EPA-HQ-OPP-2015-0203.

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

[[Page 21754]]

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 May 2, 2012 (77 FR 25904) (FRL-
9346-4).

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.
    No such effects were identified in the toxicological studies for 
acequinocyl; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 2003-2008 food consumption data from the U.S. 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). Tolerance-
level residues, Dietary Exposure Evaluation Model (DEEM) ver. 7.76 
default processing factors, and 100 percent crop treated (PCT) data 
were used in the chronic dietary assessment.
    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) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
acequinocyl for chronic exposure assessments are estimated to be 6.69 
parts per billion (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 the 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 landscape ornamentals in and around 
residences, businesses, public property, schools, interiorscapes, and 
other non-production areas. EPA assessed residential exposure using the 
following assumptions: Adult short-term residential handler dermal and 
inhalation exposure is anticipated from adults applying acequinocyl to 
trees and ornamentals with handheld equipment. Adult and youth (6-11 
years old) short-term post-application dermal exposure to acequinocyl 
is anticipated after application to trees and ornamentals. The dermal 
handler and post-application residential exposures were not included in 
the short-term aggregate assessment because different effects were seen 
in the route-specific dermal study compared to the effects seen in the 
oral studies used to select the oral and inhalation points of 
departure. 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 Food Quality 
Protection Act (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. In rats and rabbits, there 
was no evidence of increased quantitative or qualitative fetal 
susceptibility with clinical signs and gross necropsy findings seen in 
maternal animals at similar or lower doses than those producing 
resorptions. In the rat 2-generation reproductive toxicity study, 
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, however these 
effects were

[[Page 21755]]

observed at the same doses as parental effects, and a clear NOAEL was 
established which is being used in endpoint selection. There were no 
effects on reproductive parameters.
    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 that acequinocyl results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies. In the rat two-generation reproductive toxicity 
study, offspring effects were observed at the same doses as parental 
effects, and a clear NOAEL was established which is being used in 
endpoint selection.
    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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
acequinocyl is not expected to pose an acute risk.
    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 60% 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 an aggregate MOE of 22,000 for 
adults 20-49 years old. Because EPA's level of concern for acequinocyl 
is a MOE of 100 or below, this MOE is 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 (high-performance liquid 
chromatography methods with tandem mass-spectroscopy detection (HPLC/
MS/MS)) 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 an MRL for acequinocyl on hops.

V. Conclusion

    Therefore, the existing tolerance for residues of acequinocyl, 
including its metabolites and degradates, in or on ``Hop, dried cones'' 
is increased from 4.0 ppm to 15 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

[[Page 21756]]

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: April 7, 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, revise the entry for ``Hop, dried cones'' in the 
table in paragraph (a) to read as follows:


Sec.  180.599  Acequinocyl; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Hop, dried cones...........................................          15
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-08512 Filed 4-12-16; 8:45 am]
 BILLING CODE 6560-50-P
21752 Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Rules and Regulations

EPA APPROVED REGULATIONS IN THE TEXAS SIP—Continued
State
State citation Title/subject approval/sub- EPA approval date Explanation
mittal date

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Subchapter H: Administrative Provisions

Division 1: Compliance Schedules

* * * * * * *
Section 117.9030 ....... Compliance Schedule for Dallas-Fort 6/3/2015 4/13/2016 [Insert Federal Register ci-
Worth Eight-Hour Ozone Nonattain- tation].
ment Area Major Sources.

* * * * * * *
Section 117.9130 ....... Compliance Schedule For Dallas-Fort 6/3/2015 4/13/2016 [Insert Federal Register ci-
Worth Eight-Hour Ozone Nonattain- tation].
ment Area Utility Electric Generation
Sources.

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Division 2: Compliance Flexibility

Section 117.9800 ....... Use of Emission Credits For Compli- 6/3/2015 4/13/2016 [Insert Federal Register ci-
ance. tation].

* * * * * * *

[FR Doc. 2016–08158 Filed 4–12–16; 8:45 am] in the Environmental Protection Agency • Crop production (NAICS code 111).
BILLING CODE 6560–50–P Docket Center (EPA/DC), West William • Animal production (NAICS code
Jefferson Clinton Bldg., Rm. 3334, 1301 112).
Constitution Ave. NW., Washington, DC • Food manufacturing (NAICS code
ENVIRONMENTAL PROTECTION 20460–0001. The Public Reading Room 311).
AGENCY is open from 8:30 a.m. to 4:30 p.m., • Pesticide manufacturing (NAICS
Monday through Friday, excluding legal code 32532).
40 CFR Part 180 holidays. The telephone number for the
[EPA–HQ–OPP–2015–0382; FRL–9944–34] Public Reading Room is (202) 566–1744, B. How can I get electronic access to
and the telephone number for the OPP other related information?
Acequinocyl; Pesticide Tolerances Docket is (703) 305–5805. Please review You may access a frequently updated
the visitor instructions and additional electronic version of EPA’s tolerance
AGENCY: Environmental Protection information about the docket available
Agency (EPA). regulations at 40 CFR part 180 through
at http://www.epa.gov/dockets.
the Government Printing Office’s e-CFR
ACTION: Final rule. FOR FURTHER INFORMATION CONTACT: site at http://www.ecfr.gov/cgi-bin/text-
Susan Lewis, Registration Division idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
SUMMARY: This regulation increases an (7505P), Office of Pesticide Programs,
existing tolerance for residues of 40tab_02.tpl.
Environmental Protection Agency, 1200
acequinocyl in or on ‘‘Hop, dried Pennsylvania Ave. NW., Washington, C. How can I file an objection or hearing
cones.’’ Arysta LifeScience requested DC 20460–0001; main telephone request?
this tolerance increase under the number: (703) 305–7090; email address:
Federal Food, Drug, and Cosmetic Act Under FFDCA section 408(g), 21
RDFRNotices@epa.gov. U.S.C. 346a, any person may file an
(FFDCA).
SUPPLEMENTARY INFORMATION: objection to any aspect of this regulation
DATES: This regulation is effective April and may also request a hearing on those
13, 2016. Objections and requests for I. General Information
objections. You must file your objection
hearings must be received on or before A. Does this action apply to me? or request a hearing on this regulation
June 13, 2016, and must be filed in You may be potentially affected by in accordance with the instructions
accordance with the instructions this action if you are an agricultural provided in 40 CFR part 178. To ensure
provided in 40 CFR part 178 (see also producer, food manufacturer, or proper receipt by EPA, you must
Unit I.C. of the SUPPLEMENTARY pesticide manufacturer. The following identify docket ID number EPA–HQ–
INFORMATION).
jstallworth on DSK7TPTVN1PROD with RULES

list of North American Industrial OPP–2015–0382 in the subject line on
ADDRESSES: The docket for this action, Classification System (NAICS) codes is the first page of your submission. All
identified by docket identification (ID) not intended to be exhaustive, but rather objections and requests for a hearing
number EPA–HQ–OPP–2015–0382, is provides a guide to help readers must be in writing, and must be
available at http://www.regulations.gov determine whether this document received by the Hearing Clerk on or
or at the Office of Pesticide Programs applies to them. Potentially affected before June 13, 2016. Addresses for mail
Regulatory Public Docket (OPP Docket) entities may include: and hand delivery of objections and

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Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Rules and Regulations 21755

observed at the same doses as parental 2. Chronic risk. Using the exposure from aggregate exposure to acequinocyl
effects, and a clear NOAEL was assumptions described in this unit for residues.
established which is being used in chronic exposure, EPA has concluded
IV. Other Considerations
endpoint selection. There were no that chronic exposure to acequinocyl
effects on reproductive parameters. from food and water will utilize 60% of A. Analytical Enforcement Methodology
3. Conclusion. EPA has determined the cPAD for children 1–2 years old, the Adequate enforcement methodology
that reliable data show the safety of population group receiving the greatest (high-performance liquid
infants and children would be exposure. Based on the explanation in chromatography methods with tandem
adequately protected if the FQPA SF Unit III.C.3., regarding residential use mass-spectroscopy detection (HPLC/
were reduced to 1x. That decision is patterns, chronic residential exposure to MS/MS)) is available to enforce the
based on the following findings: residues of acequinocyl is not expected. tolerance expression.
i. The toxicity database for 3. Short-term risk. Short-term The method may be requested from:
acequinocyl is complete. aggregate exposure takes into account Chief, Analytical Chemistry Branch,
ii. There is no indication that short-term residential exposure plus Environmental Science Center, 701
acequinocyl is a neurotoxic chemical chronic exposure to food and water Mapes Rd., Ft. Meade, MD 20755–5350;
and there is no need for a (considered to be a background telephone number: (410) 305–2905;
developmental neurotoxicity study or exposure level). Acequinocyl is email address: residuemethods@
additional UFs to account for currently registered for uses that could epa.gov.
neurotoxicity. result in short-term residential
iii. There is no evidence that exposure, and the Agency has B. International Residue Limits
acequinocyl results in increased determined that it is appropriate to In making its tolerance decisions, EPA
susceptibility in in utero rats or rabbits aggregate chronic exposure through food seeks to harmonize U.S. tolerances with
in the prenatal developmental studies. and water with short-term residential international standards whenever
In the rat two-generation reproductive exposures to acequinocyl. possible, consistent with U.S. food
toxicity study, offspring effects were Using the exposure assumptions safety standards and agricultural
observed at the same doses as parental described in this unit for short-term practices. EPA considers the
effects, and a clear NOAEL was exposures, EPA has concluded the international maximum residue limits
established which is being used in combined short-term food, water, and (MRLs) established by the Codex
endpoint selection. residential exposures result in an Alimentarius Commission (Codex), as
iv. There are no residual uncertainties aggregate MOE of 22,000 for adults 20– required by FFDCA section 408(b)(4).
identified in the exposure databases. 49 years old. Because EPA’s level of The Codex Alimentarius is a joint
The dietary food exposure assessments concern for acequinocyl is a MOE of 100 United Nations Food and Agriculture
were performed based on 100 PCT and or below, this MOE is not of concern. Organization/World Health
tolerance-level residues. EPA made 4. Intermediate-term risk. Organization food standards program,
conservative (protective) assumptions in Intermediate-term aggregate exposure and it is recognized as an international
the ground and surface water modeling takes into account intermediate-term food safety standards-setting
used to assess exposure to acequinocyl residential exposure plus chronic organization in trade agreements to
in drinking water. EPA used similarly exposure to food and water (considered which the United States is a party. EPA
conservative assumptions to assess post- to be a background exposure level). may establish a tolerance that is
application exposure of children. These An intermediate-term adverse effect different from a Codex MRL; however,
assessments will not underestimate the was identified; however, acequinocyl is FFDCA section 408(b)(4) requires that
exposure and risks posed by not registered for any use patterns that EPA explain the reasons for departing
acequinocyl. would result in intermediate-term from the Codex level.
residential exposure. Intermediate-term The Codex has not established an
E. Aggregate Risks and Determination of risk is assessed based on intermediate-
Safety MRL for acequinocyl on hops.
term residential exposure plus chronic
EPA determines whether acute and dietary exposure. Because there is no V. Conclusion
chronic dietary pesticide exposures are intermediate-term residential exposure Therefore, the existing tolerance for
safe by comparing aggregate exposure and chronic dietary exposure has residues of acequinocyl, including its
estimates to the acute PAD (aPAD) and already been assessed under the metabolites and degradates, in or on
chronic PAD (cPAD). For linear cancer appropriately protective cPAD (which is ‘‘Hop, dried cones’’ is increased from
risks, EPA calculates the lifetime at least as protective as the POD used to 4.0 ppm to 15 ppm.
probability of acquiring cancer given the assess intermediate-term risk), no
estimated aggregate exposure. Short-, VI. Statutory and Executive Order
further assessment of intermediate-term
intermediate-, and chronic-term risks Reviews
risk is necessary, and EPA relies on the
are evaluated by comparing the chronic dietary risk assessment for This action establishes tolerances
estimated aggregate food, water, and evaluating intermediate-term risk for under FFDCA section 408(d) in
residential exposure to the appropriate acequinocyl. response to a petition submitted to the
PODs to ensure that an adequate MOE 5. Aggregate cancer risk for U.S. Agency. The Office of Management and
exists. population. Based on the lack of Budget (OMB) has exempted these types
1. Acute risk. An acute aggregate risk evidence of carcinogenicity in two of actions from review under Executive
assessment takes into account acute adequate rodent carcinogenicity studies, Order 12866, entitled ‘‘Regulatory
jstallworth on DSK7TPTVN1PROD with RULES

exposure estimates from dietary acequinocyl is not expected to pose a Planning and Review’’ (58 FR 51735,
consumption of food and drinking cancer risk to humans. October 4, 1993). Because this action
water. No adverse effect resulting from 6. Determination of safety. Based on has been exempted from review under
a single oral exposure was identified these risk assessments, EPA concludes Executive Order 12866, this action is
and no acute dietary endpoint was that there is a reasonable certainty that not subject to Executive Order 13211,
selected. Therefore, acequinocyl is not no harm will result to the general entitled ‘‘Actions Concerning
expected to pose an acute risk. population, or to infants and children Regulations That Significantly Affect

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Document Created: 2016-04-13 03:10:47
Document Modified: 2016-04-13 03:10:47
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective April 13, 2016. Objections and requests for hearings must be received on or before June 13, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		81 FR 21752
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements