Acequinocyl; Pesticide Tolerances, 21752-21756 [2016-08512]
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Federal Register / Vol. 81, No. 71 / Wednesday, April 13, 2016 / Rules and Regulations
EPA APPROVED REGULATIONS IN THE TEXAS SIP—Continued
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Explanation
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Subchapter H: Administrative Provisions
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Division 2: Compliance Flexibility
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[FR Doc. 2016–08158 Filed 4–12–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0382; FRL–9944–34]
Acequinocyl; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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).
SUMMARY:
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).
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DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0382, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
ADDRESSES:
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6/3/2015
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4/13/2016 [Insert Federal Register citation].
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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 https://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:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
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• 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 https://www.ecfr.gov/cgi-bin/textidx?&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
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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: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
jstallworth on DSK7TPTVN1PROD with RULES
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, https://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
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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
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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 2generation reproductive toxicity study,
offspring effects at the mid- and highdoses 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-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
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
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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 https://www2.
epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-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).
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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
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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
https://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-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 × 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 nonoccupational, 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 nonproduction 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) shortterm post-application dermal exposure
to acequinocyl is anticipated after
application to trees and ornamentals.
The dermal handler and postapplication 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 https://www2.epa.gov/pesticide-
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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
https://www2.epa.gov/pesticide-scienceand-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 2generation reproductive toxicity study,
offspring effects at the mid- and highdoses consisted of swollen body parts,
protruding eyes, clinical signs, delays in
pupil development, and increased
mortality occurring mainly after
weaning, however these effects were
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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 postapplication 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.
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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 intermediateterm 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
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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: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
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
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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
VerDate Sep<11>2014
14:03 Apr 12, 2016
Jkt 238001
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]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.599, revise the entry for
‘‘Hop, dried cones’’ in the table in
paragraph (a) to read as follows:
■
§ 180.599 Acequinocyl; tolerances for
residues.
(a) * * *
Commodity
Parts per
million
*
*
*
*
Hop, dried cones ........................
15
*
*
*
*
*
*
*
*
*
*
*
[FR Doc. 2016–08512 Filed 4–12–16; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 679
[Docket No. 150916863–6211–02]
RIN 0648–XE563
Fisheries of the Exclusive Economic
Zone Off Alaska; Pacific Cod in the
Bering Sea Subarea of the Bering Sea
and Aleutian Islands Management Area
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; modification of
a closure.
AGENCY:
NMFS is opening directed
fishing for Pacific cod by catcher vessels
SUMMARY:
PO 00000
Frm 00058
Fmt 4700
Sfmt 4700
using trawl gear in the Bering Sea
subarea of the Bering Sea and Aleutian
Islands Management Area (BSAI). This
action is necessary to fully use the B
season apportionment of the 2016 total
allowable catch (TAC) of Pacific cod
allocated to trawl catcher vessels in the
BSAI.
DATES: Effective 1200 hrs, Alaska local
time (A.l.t.), April 11, 2016, through
2400 hrs, A.l.t., June 10, 2016.
Comments must be received at the
following address no later than 4:30
p.m., A.l.t., April 28, 2016.
ADDRESSES: You may submit comments
on this document, identified by NOAA–
NMFS–2015–0118, by any of the
following methods:
• Electronic Submission: Submit all
electronic public comments via the
Federal e-Rulemaking Portal. Go to
www.regulations.gov/#!docketDetail;
D=NOAA-NMFS-2015-0118, click the
‘‘Comment Now!’’ icon, complete the
required fields, and enter or attach your
comments.
• Mail: Submit written comments to
Glenn Merrill, Assistant Regional
Administrator, Sustainable Fisheries
Division, Alaska Region NMFS, Attn:
Ellen Sebastian. Mail comments to P.O.
Box 21668, Juneau, AK 99802–1668.
Instructions: Comments sent by any
other method, to any other address or
individual, or received after the end of
the comment period, may not be
considered by NMFS. All comments
received are a part of the public record
and will generally be posted for public
viewing on www.regulations.gov
without change. All personal identifying
information (e.g., name, address),
confidential business information, or
otherwise sensitive information
submitted voluntarily by the sender will
be publicly accessible. NMFS will
accept anonymous comments (enter ‘‘N/
A’’ in the required fields if you wish to
remain anonymous).
FOR FURTHER INFORMATION CONTACT: Josh
Keaton, 907–586–7228.
SUPPLEMENTARY INFORMATION: NMFS
manages the groundfish fishery in the
BSAI exclusive economic zone
according to the Fishery Management
Plan for Groundfish of the Bering Sea
and Aleutian Islands Management Area
(FMP) prepared by the North Pacific
Fishery Management Council under
authority of the Magnuson-Stevens
Fishery Conservation and Management
Act. Regulations governing fishing by
U.S. vessels in accordance with the FMP
appear at subpart H of 50 CFR part 600
and 50 CFR part 679.
NMFS closed directed fishing for
Pacific cod by catcher vessels using
trawl gear in the BSAI under
E:\FR\FM\13APR1.SGM
13APR1
Agencies
[Federal Register Volume 81, Number 71 (Wednesday, April 13, 2016)]
[Rules and Regulations]
[Pages 21752-21756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08512]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://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: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://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, https://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 https://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 https://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 https://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 https://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 https://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:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that 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