Methoxyfenozide; Pesticide Tolerances for Emergency Exemptions, 27332-27337 [2016-09969]
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Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Rules and Regulations
is published in the Federal Register.
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Court of Appeals for the appropriate
circuit by July 5, 2016. Filing a petition
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of this final rule does not affect the
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time within which a petition for judicial
review may be filed, and shall not
postpone the effectiveness of such rule
or action. This action may not be
challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
List of Subjects in 40 CFR Part 52
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pollution control, Incorporation by
reference, Intergovernmental relations,
Reporting and recordkeeping
requirements, Sulfur oxides.
■
Dated: April 27, 2016.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.
1. The authority citation for part 52
continues to read as follows:
Authority: 42 U.S.C. 7401 et seq.
2. In § 52.770 the table in paragraph
(d) is amended by adding new entries
for ‘‘A.B. Brown Generating Station’’
and ‘‘Clifty Creek Generating Station’’,
to read as follows:
§ 52.770
40 CFR part 52 is amended as follows:
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Limitation intended to support attainment designation.
This regulation is effective May
6, 2016. Objections and requests for
hearings must be received on or before
July 5, 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).
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0591, 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.
ADDRESSES:
[EPA–HQ–OPP–2014–0591; FRL–9945–28]
Methoxyfenozide; Pesticide Tolerances
for Emergency Exemptions
Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
Final rule.
This regulation establishes
time-limited tolerances for residues of
methoxyfenozide in or on rice, grain
and rice, bran resulting from use of
methoxyfenozide in accordance with
the terms of an emergency exemption
issued under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA). This action is in response
to the California Department of
Pesticide Regulation’s issuance of a
crisis emergency exemption under
FIFRA section 18 authorizing use of the
pesticide on rice, bran and rice, grain.
This time-limited tolerance regulation
establishes a maximum permissible
level for residues of methoxyfenozide in
or on these commodities. These timelimited tolerances expire on December
31, 2019.
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SUMMARY:
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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:
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*
Limitation intended to support attainment designation.
DATES:
[FR Doc. 2016–10579 Filed 5–5–16; 8:45 am]
*
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 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 section 408(g) of the Federal
Food, Drug, and Cosmetic Act (FFDCA),
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
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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–2014–0591 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 July 5, 2016. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2014–0591, 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. Background and Statutory Findings
EPA, on its own initiative, in
accordance with FFDCA sections 408(e)
and 408(l)(6) of, 21 U.S.C. 346a(e) and
346a(1)(6), is establishing time-limited
tolerances for residues of
methoxyfenozide in or on rice, bran and
rice, grain at 4.0 and 0.50 parts per
million (ppm), respectively. These timelimited tolerances expire on December
31, 2019.
Section 408(l)(6) of FFDCA requires
EPA to establish a time-limited
tolerance or exemption from the
requirement for a tolerance for pesticide
chemical residues in food that will
result from the use of a pesticide under
an emergency exemption granted by
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EPA under FIFRA section 18. Such
tolerances can be established without
providing notice or period for public
comment. EPA does not intend for its
actions on FIFRA section 18 related
time-limited tolerances to set binding
precedents for the application of FFDCA
section 408 and the safety standard to
other tolerances and exemptions.
Section 408(e) of FFDCA allows EPA to
establish a tolerance or an exemption
from the requirement of a tolerance on
its own initiative, i.e., without having
received any petition from an outside
party.
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. . . .’’
Section 18 of FIFRA authorizes EPA
to exempt any Federal or State agency
from any provision of FIFRA, if EPA
determines that ‘‘emergency conditions
exist which require such exemption.’’
EPA has established regulations
governing such emergency exemptions
in 40 CFR part 166.
III. Emergency Exemption for
Methoxyfenozide on Rice, Grain and
Rice, Bran and FFDCA Tolerances
The California Department of
Pesticide Regulation asserted that an
emergency condition existed in
accordance with the criteria for
approval of an emergency exemption,
and utilized a crisis exemption under
FIFRA section 18 to allow the use of
methoxyfenozide on rice to control
armyworm and Western yellow striped
armyworm in Butte, Glenn, Sacramento,
Sutter, Yolo, and Yuba counties. The
California Department of Pesticide
Regulation invoked the crisis exemption
provision on August 27, 2015. After
having reviewed the submission and
determining that the risks associated
with the emergency use were reasonable
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in comparison to the expected benefits
to the California rice growers who faced
the largest outbreak of armyworms in 25
years and significant economic loss,
EPA concurred on the crisis exemption.
The crisis exemption expired on
September 10, 2015.
As part of its evaluation of the
emergency exemption application, EPA
assessed the potential risks presented by
residues of methoxyfenozide in or on
rice, bran and rice, grain. In doing so,
EPA considered the safety standard in
FFDCA section 408(b)(2), and EPA
decided that the necessary tolerances
under FFDCA section 408(l)(6) would be
consistent with the safety standard and
with FIFRA section 18. Consistent with
the need to move quickly on the
emergency exemption in order to
address an urgent non-routine situation
and to ensure that the resulting food is
safe and lawful, EPA is issuing these
tolerances without notice and
opportunity for public comment as
provided in FFDCA section 408(l)(6).
Although these time-limited tolerances
expire on December 31, 2019, under
FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts
specified in the tolerances remaining in
or on rice, bran and rice, grain after that
date will not be unlawful, provided the
pesticide was applied in a manner that
was lawful under FIFRA, and the
residues do not exceed a level that was
authorized by these time-limited
tolerances at the time of that
application. EPA will take action to
revoke these time-limited tolerances
earlier if any experience with, scientific
data on, or other relevant information
on this pesticide indicate that the
residues are not safe.
Because these time-limited tolerances
are being approved under emergency
conditions, EPA has not made any
decisions about whether
methoxyfenozide meets FIFRA’s
registration requirements for use on rice,
grain and rice, bran or whether
permanent tolerances for this use would
be appropriate. Under these
circumstances, EPA does not believe
that these time-limited tolerance
decisions serve as a basis for registration
of methoxyfenozide by a State for
special local needs under FIFRA section
24(c). Nor do these tolerances by
themselves serve as the authority for
persons in any State other than
California to use this pesticide on the
applicable crops under FIFRA section
18 absent the issuance of an emergency
exemption applicable within that State.
For additional information regarding the
crisis emergency exemption for
methoxyfenozide, contact the Agency’s
Registration Division at the address
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provided under FOR FURTHER
INFORMATION CONTACT.
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IV. 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 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 expected as a result
of this emergency exemption request
and the time-limited tolerances for
residues of methoxyfenozide on rice,
bran and rice, grain at 4.0 and 0.50 ppm,
respectively, measured as 3-methoxy-2methylbenzoic acid 2-(3,5dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide. EPA’s assessment of
exposures and risks associated with
establishing time-limited tolerances
follows.
A. 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/
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safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for methoxyfenozide used for
human risk assessment is discussed in
Table 1 of Unit III B. of the final rule
published in the Federal Register of
August 27, 2014 (79 FR 51103) (FRL–
9913–99). Further, the Agency’s
exposure and risk assessment for the
emergency use on rice, bran and rice,
grain is discussed in greater detail in
‘‘Methoxyfenozide: Human Health Risk
Assessment for the Proposed Use of the
Insecticide (Associated with Section 18
Registration) on Rice in California,’’
January 5, 2016 is available in the
docket at the address provided under
ADDRESSES.
B. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to methoxyfenozide, EPA
considered exposure under the timelimited tolerances established by this
action as well as all existing
methoxyfenozide tolerances in 40 CFR
180.544. EPA assessed dietary
exposures from methoxyfenozide 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 methoxyfenozide; therefore, a
quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting
the chronic aggregate dietary (food and
drinking water) exposure and risk
assessment, EPA used the Dietary
Exposure Evaluation Model software
(Version 3.16) with the Food
Commodity Intake Database (DEEM–
FCID). This software includes 2003 to
2008 food consumption data from the
United States Department of
Agriculture’s (USDA’s) National Health
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and Nutrition Examination Survey,
What We Eat in America (NHANES/
WWEIA). All current and proposed uses
of methoxyfenozide, were included in
this assessment. As to residue levels in
food, the chronic dietary assessment
assumes 100% crop treated (PCT).
DEEM (Version 7.81) default processing
factors were used for most processed
commodities that do not have
individual tolerances. The only
exception was a processing factor of
0.2X that was used for orange juice from
a processing study. The chronic dietary
assessment is highly conservative
(protective); therefore, providing an
upper-bound estimate of dietary
exposure and risk.
iii. Cancer. Based on the data
referenced in Unit IV.A., EPA has
concluded that methoxyfenozide should
be classified as ‘‘Not Likely to Be
Carcinogenic to Humans.’’ As a result, a
cancer dietary exposure assessment for
the purpose of assessing cancer risk is
unnecessary for methoxyfenozide, and
was not conducted.
2. Dietary exposure from drinking
water. The residues of concern in
drinking water are methoxyfenozide and
the degradates, RH–117,236 and RH–
131,154, which are only present at low
concentrations. The Agency used
screening-level water exposure models
in the dietary exposure analysis and risk
assessment for methoxyfenozide and its
degradates in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of
methoxyfenozide and its degradates.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed1/models/
water/index.htm.
Based on the FPQA Index Reservoir
Screening Tool (FIRST), Screening
Concentration in Ground Water (SCI–
GROW), and the Pesticide Root Zone
Model Ground Water (PRZM GW)
models, the estimated drinking water
concentrations (EDWCs) of
methoxyfenozide and its degradates for
chronic exposures for non-cancer
assessments are estimated to be 7.57
parts per billion (ppb) for surface water
and 214 ppb for ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration of value 214 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
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(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Methoxyfenozide is currently registered
for use on ornamentals in and around
home gardens, which could result in
residential exposures. EPA assessed
residential exposure using the following
assumptions: Residential handlers were
assessed for potential short-term
inhalation exposures from mixing,
loading, and applying methoxyfenozide.
A quantitative dermal assessment for
residential handlers was not conducted
since there is no systemic toxicity
associated with dermal exposures to
methoxyfenozide. Adult postapplication exposures were not
quantitatively assessed since no dermal
hazard was identified for
methoxyfenozide and inhalation
exposures are typically negligible in
outdoor settings. Furthermore, the
inhalation exposure assessment
performed for residential handlers is
representative of worse case inhalation
exposures and is considered protective
for post-application inhalation exposure
scenarios.
Post-application oral exposure to
children is not expected since the extent
to which young children engage in
activities associated with areas where
treated ornamentals are grown (or
utilize these areas for prolonged periods
of play) is low. Therefore, an incidental
oral post-application exposure
assessment was not conducted. Further
information regarding EPA standard
assumptions and generic inputs for
residential exposures may be found at
https://www.epa.gov/pesticides/trac/
science/trac6a05.pdf.
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 methoxyfenozide
to share a common mechanism of
toxicity with any other substances, and
methoxyfenozide does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that methoxyfenozide 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
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chemicals, see EPA’s Web site at http:
//www.epa.gov/pesticides/cumulative.
C. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
Food Quality Protection Act Safety
Factor (FQPA SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional SF when reliable data
available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity.
There is no evidence of qualitative or
quantitative susceptibility of the
developing fetus or offspring, based on
the developmental and reproductive
toxicity study results for
methoxyfenozide. No developmental
toxicity was observed in either the rat or
rabbit developmental toxicity studies,
and there was no evidence of offspring
or reproductive toxicity in the rat twogeneration reproductive toxicity study.
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
methoxyfenozide is complete, including
studies addressing potential pre- and
post-natal susceptibility, neurotoxicity,
and immunotoxicity.
ii. There is no evidence that
methoxyfenozide is neurotoxic, and a
developmental neurotoxicity study or
additional uncertainty factors (UFs) to
account for neurotoxicity are not
required.
iii. There is no residual uncertainty,
and no evidence increased
susceptibility in the developing or
young animal.
iv. The dietary exposure assessments
do not underestimate potential exposure
from food and drinking water, and the
use pattern indicates a low potential for
residential exposure.
D. 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
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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 so, there is no acute dietary
endpoint of concern. Therefore,
methoxyfenozide 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
methoxyfenozide from food and water
will utilize 84% of the cPAD for
children 1 to 2 years old, the population
group receiving the greatest exposure.
Based on the explanation regarding
residential use patterns, chronic
residential exposure to residues of
methoxyfenozide 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). Methoxyfenozide 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 methoxyfenozide.
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 540. Because EPA’s
level of concern for methoxyfenozide is
a MOE of 100 or below, these MOEs are
not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level). An
intermediate-term adverse effect was
identified; however, methoxyfenozide 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
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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
methoxyfenozide.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
methoxyfenozide 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
methoxyfenozide residues.
EPA concludes that there is
reasonable certainty that no harm will
result to the general population, or to
infants and children, from aggregate
exposure to methoxyfenozide residues
because the Section 18 emergency use of
methoxyfenozide on rice will result in
negligible increases in dietary exposure
to all subgroups relative to the safety
findings reached in the August 27, 2014
Federal Register document.
V. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement
methodology is available to enforce the
tolerance expression, using high
performance liquid chromatography
(HPLC), with either tandem mass
spectrometric detection (LC–MS/MS), or
ultraviolet detection (UV).
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.
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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
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13:56 May 05, 2016
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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.
There are currently no established
Codex or Canadian MRLs for
methoxyfenozide residues in rice
commodities.
VI. Conclusion
Therefore, time-limited tolerances are
established for residues of
methoxyfenozide, (3-methoxy-2methylbenzoic acid 2-(3,5dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide), in or on rice, grain at 0.50
ppm; and rice, bran at 4.0 ppm. These
tolerances will expire on December 31,
2019.
VII. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA sections 408(e) and
408(l)(6). The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established in accordance with
FFDCA sections 408(e) and 408(l)(6),
such as the tolerances 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
PO 00000
Frm 00042
Fmt 4700
Sfmt 4700
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).
VIII. 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 21, 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 § 180.544, revise paragraph (b) to
read as follows:
■
§ 180.544 Methoxyfenozide; tolerances for
residues.
*
E:\FR\FM\06MYR1.SGM
*
*
06MYR1
*
*
Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Rules and Regulations
(b) Section 18 emergency exemptions.
Time-limited tolerances are established
for residues of the insecticide
methoxyfenozide, including its
metabolites and degradates in or on the
commodities listed in the table below,
resulting from use of the pesticide under
a Section 18 emergency exemption
granted by EPA. Compliance with the
tolerance levels specified in the
following table is to be determined by
measuring only methoxyfenozide (3methoxy-2-methylbenzoic acid 2-(3,5dimethylbenzoyl)-2-(1,1-dimethylethyl)
hydrazide) in or on the commodity.
Commodity
Parts per
million
Rice, bran
4.0
Rice,
grain.
*
*
0.50
*
*
Expiration/
revocation date
I. General Information
December 31,
2019.
December 31,
2019.
*
[FR Doc. 2016–09969 Filed 5–5–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0035; FRL–9945–68]
Clethodim; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of clethodim in
or on multiple commodities which are
identified and discussed later in this
document. Interregional Research
Project Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May
6, 2016. Objections and requests for
hearings must be received on or before
July 5, 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).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0035, 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.,
Lhorne on DSK30JT082PROD with RULES
ADDRESSES:
VerDate Sep<11>2014
13:56 May 05, 2016
Jkt 238001
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:
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/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–2015–0035 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 July 5, 2016. Addresses for mail
and hand delivery of objections and
PO 00000
Frm 00043
Fmt 4700
Sfmt 4700
27337
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–
2015–0035, 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 Wednesday,
May 20, 2015 (80 FR 28925) (FRL–9927–
39), 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 4E8334) by
Interregional Research Project Number 4
(IR–4), 500 College Road East, Suite 201
W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.458 be
amended by establishing tolerances for
residues of the herbicide clethodim, 2[(1E)-1-[[[(2E)-3-chloro-2propenyl]oxy]imino]propyl]-5-[2(ethylthio)propyl]-3-hydroxy-2cyclohexen-1-one, and its metabolites
containing the 5-(2ethylthiopropyl)cyclohexene-3-one and
5-(2-ethylthiopropyl)-5hydroxycyclohexene-3-one moieties and
their sulphoxides and sulphones,
calculated as the stoichiometric
equivalent of clethodim, in or on stevia
at 12 parts per million (ppm); pome fruit
group 11–10 at 0.2 ppm; stone fruit
group 12–12 at 0.2 ppm; bulb onion
subgroup 3–07A at 0.2 ppm; low
growing berry subgroup 13–07G, except
cranberry at 3.0 ppm; rapeseed
subgroup 20A, except flax 0.5 ppm;
E:\FR\FM\06MYR1.SGM
06MYR1
]]>Agencies
[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)]
[Rules and Regulations]
[Pages 27332-27337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09969]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0591; FRL-9945-28]
Methoxyfenozide; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
residues of methoxyfenozide in or on rice, grain and rice, bran
resulting from use of methoxyfenozide in accordance with the terms of
an emergency exemption issued under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). This action is in
response to the California Department of Pesticide Regulation's
issuance of a crisis emergency exemption under FIFRA section 18
authorizing use of the pesticide on rice, bran and rice, grain. This
time-limited tolerance regulation establishes a maximum permissible
level for residues of methoxyfenozide in or on these commodities. These
time-limited tolerances expire on December 31, 2019.
DATES: This regulation is effective May 6, 2016. Objections and
requests for hearings must be received on or before July 5, 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-2014-0591, 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:
[emsp14]Crop production (NAICS code 111).
[emsp14]Animal production (NAICS code 112).
[emsp14]Food manufacturing (NAICS code 311).
[emsp14]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 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 section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 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
[[Page 27333]]
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-2014-0591 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 July 5,
2016. Addresses for mail and hand delivery of objections and hearing
requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0591, 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. Background and Statutory Findings
EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is
establishing time-limited tolerances for residues of methoxyfenozide in
or on rice, bran and rice, grain at 4.0 and 0.50 parts per million
(ppm), respectively. These time-limited tolerances expire on December
31, 2019.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of FFDCA section 408 and the safety
standard to other tolerances and exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
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. . .
.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Methoxyfenozide on Rice, Grain and Rice,
Bran and FFDCA Tolerances
The California Department of Pesticide Regulation asserted that an
emergency condition existed in accordance with the criteria for
approval of an emergency exemption, and utilized a crisis exemption
under FIFRA section 18 to allow the use of methoxyfenozide on rice to
control armyworm and Western yellow striped armyworm in Butte, Glenn,
Sacramento, Sutter, Yolo, and Yuba counties. The California Department
of Pesticide Regulation invoked the crisis exemption provision on
August 27, 2015. After having reviewed the submission and determining
that the risks associated with the emergency use were reasonable in
comparison to the expected benefits to the California rice growers who
faced the largest outbreak of armyworms in 25 years and significant
economic loss, EPA concurred on the crisis exemption. The crisis
exemption expired on September 10, 2015.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of
methoxyfenozide in or on rice, bran and rice, grain. In doing so, EPA
considered the safety standard in FFDCA section 408(b)(2), and EPA
decided that the necessary tolerances under FFDCA section 408(l)(6)
would be consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment as provided in FFDCA
section 408(l)(6). Although these time-limited tolerances expire on
December 31, 2019, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerances
remaining in or on rice, bran and rice, grain after that date will not
be unlawful, provided the pesticide was applied in a manner that was
lawful under FIFRA, and the residues do not exceed a level that was
authorized by these time-limited tolerances at the time of that
application. EPA will take action to revoke these time-limited
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
methoxyfenozide meets FIFRA's registration requirements for use on
rice, grain and rice, bran or whether permanent tolerances for this use
would be appropriate. Under these circumstances, EPA does not believe
that these time-limited tolerance decisions serve as a basis for
registration of methoxyfenozide by a State for special local needs
under FIFRA section 24(c). Nor do these tolerances by themselves serve
as the authority for persons in any State other than California to use
this pesticide on the applicable crops under FIFRA section 18 absent
the issuance of an emergency exemption applicable within that State.
For additional information regarding the crisis emergency exemption for
methoxyfenozide, contact the Agency's Registration Division at the
address
[[Page 27334]]
provided under FOR FURTHER INFORMATION CONTACT.
IV. 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 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 expected as a result of this emergency exemption request and
the time-limited tolerances for residues of methoxyfenozide on rice,
bran and rice, grain at 4.0 and 0.50 ppm, respectively, measured as 3-
methoxy-2-methylbenzoic acid 2-(3,5-dimethylbenzoyl)-2-(1,1-
dimethylethyl)-hydrazide. EPA's assessment of exposures and risks
associated with establishing time-limited tolerances follows.
A. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for methoxyfenozide used
for human risk assessment is discussed in Table 1 of Unit III B. of the
final rule published in the Federal Register of August 27, 2014 (79 FR
51103) (FRL-9913-99). Further, the Agency's exposure and risk
assessment for the emergency use on rice, bran and rice, grain is
discussed in greater detail in ``Methoxyfenozide: Human Health Risk
Assessment for the Proposed Use of the Insecticide (Associated with
Section 18 Registration) on Rice in California,'' January 5, 2016 is
available in the docket at the address provided under ADDRESSES.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to methoxyfenozide, EPA considered exposure under the time-
limited tolerances established by this action as well as all existing
methoxyfenozide tolerances in 40 CFR 180.544. EPA assessed dietary
exposures from methoxyfenozide 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 methoxyfenozide; therefore,
a quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic aggregate dietary
(food and drinking water) exposure and risk assessment, EPA used the
Dietary Exposure Evaluation Model software (Version 3.16) with the Food
Commodity Intake Database (DEEM-FCID). This software includes 2003 to
2008 food consumption data from the United States Department of
Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). All current and proposed
uses of methoxyfenozide, were included in this assessment. As to
residue levels in food, the chronic dietary assessment assumes 100%
crop treated (PCT). DEEM (Version 7.81) default processing factors were
used for most processed commodities that do not have individual
tolerances. The only exception was a processing factor of 0.2X that was
used for orange juice from a processing study. The chronic dietary
assessment is highly conservative (protective); therefore, providing an
upper-bound estimate of dietary exposure and risk.
iii. Cancer. Based on the data referenced in Unit IV.A., EPA has
concluded that methoxyfenozide should be classified as ``Not Likely to
Be Carcinogenic to Humans.'' As a result, a cancer dietary exposure
assessment for the purpose of assessing cancer risk is unnecessary for
methoxyfenozide, and was not conducted.
2. Dietary exposure from drinking water. The residues of concern in
drinking water are methoxyfenozide and the degradates, RH-117,236 and
RH-131,154, which are only present at low concentrations. The Agency
used screening-level water exposure models in the dietary exposure
analysis and risk assessment for methoxyfenozide and its degradates in
drinking water. These simulation models take into account data on the
physical, chemical, and fate/transport characteristics of
methoxyfenozide and its degradates. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the FPQA Index Reservoir Screening Tool (FIRST), Screening
Concentration in Ground Water (SCI-GROW), and the Pesticide Root Zone
Model Ground Water (PRZM GW) models, the estimated drinking water
concentrations (EDWCs) of methoxyfenozide and its degradates for
chronic exposures for non-cancer assessments are estimated to be 7.57
parts per billion (ppb) for surface water and 214 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 214 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
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(e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Methoxyfenozide is
currently registered for use on ornamentals in and around home gardens,
which could result in residential exposures. EPA assessed residential
exposure using the following assumptions: Residential handlers were
assessed for potential short-term inhalation exposures from mixing,
loading, and applying methoxyfenozide. A quantitative dermal assessment
for residential handlers was not conducted since there is no systemic
toxicity associated with dermal exposures to methoxyfenozide. Adult
post-application exposures were not quantitatively assessed since no
dermal hazard was identified for methoxyfenozide and inhalation
exposures are typically negligible in outdoor settings. Furthermore,
the inhalation exposure assessment performed for residential handlers
is representative of worse case inhalation exposures and is considered
protective for post-application inhalation exposure scenarios.
Post-application oral exposure to children is not expected since
the extent to which young children engage in activities associated with
areas where treated ornamentals are grown (or utilize these areas for
prolonged periods of play) is low. Therefore, an incidental oral post-
application exposure assessment was not conducted. Further information
regarding EPA standard assumptions and generic inputs for residential
exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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 methoxyfenozide to share a common mechanism of
toxicity with any other substances, and methoxyfenozide does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
methoxyfenozide 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://www.epa.gov/pesticides/cumulative.
C. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
SF when reliable data available to EPA support the choice of a
different factor.
2. Prenatal and postnatal sensitivity. There is no evidence of
qualitative or quantitative susceptibility of the developing fetus or
offspring, based on the developmental and reproductive toxicity study
results for methoxyfenozide. No developmental toxicity was observed in
either the rat or rabbit developmental toxicity studies, and there was
no evidence of offspring or reproductive toxicity in the rat two-
generation reproductive toxicity study.
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 methoxyfenozide is complete, including
studies addressing potential pre- and post-natal susceptibility,
neurotoxicity, and immunotoxicity.
ii. There is no evidence that methoxyfenozide is neurotoxic, and a
developmental neurotoxicity study or additional uncertainty factors
(UFs) to account for neurotoxicity are not required.
iii. There is no residual uncertainty, and no evidence increased
susceptibility in the developing or young animal.
iv. The dietary exposure assessments do not underestimate potential
exposure from food and drinking water, and the use pattern indicates a
low potential for residential exposure.
D. 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 so, there is no acute dietary endpoint of concern.
Therefore, methoxyfenozide 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
methoxyfenozide from food and water will utilize 84% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation regarding residential use patterns,
chronic residential exposure to residues of methoxyfenozide 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).
Methoxyfenozide 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 methoxyfenozide.
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 540. Because
EPA's level of concern for methoxyfenozide is a MOE of 100 or below,
these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
methoxyfenozide 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
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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 methoxyfenozide.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, methoxyfenozide 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 methoxyfenozide residues.
EPA concludes that there is reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to methoxyfenozide residues because the Section 18
emergency use of methoxyfenozide on rice will result in negligible
increases in dietary exposure to all subgroups relative to the safety
findings reached in the August 27, 2014 Federal Register document.
V. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement methodology is available to enforce the
tolerance expression, using high performance liquid chromatography
(HPLC), with either tandem mass spectrometric detection (LC-MS/MS), or
ultraviolet detection (UV).
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.
There are currently no established Codex or Canadian MRLs for
methoxyfenozide residues in rice commodities.
VI. Conclusion
Therefore, time-limited tolerances are established for residues of
methoxyfenozide, (3-methoxy-2-methylbenzoic acid 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl)-hydrazide), in or on rice, grain
at 0.50 ppm; and rice, bran at 4.0 ppm. These tolerances will expire on
December 31, 2019.
VII. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive
Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This
action does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
Since tolerances and exemptions that are established in accordance
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances 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).
VIII. 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 21, 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. 180.544, revise paragraph (b) to read as follows:
Sec. 180.544 Methoxyfenozide; tolerances for residues.
* * * * *
[[Page 27337]]
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the insecticide methoxyfenozide, including
its metabolites and degradates in or on the commodities listed in the
table below, resulting from use of the pesticide under a Section 18
emergency exemption granted by EPA. Compliance with the tolerance
levels specified in the following table is to be determined by
measuring only methoxyfenozide (3-methoxy-2-methylbenzoic acid 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide) in or on the
commodity.
------------------------------------------------------------------------
Parts per
Commodity million Expiration/ revocation date
------------------------------------------------------------------------
Rice, bran..................... 4.0 December 31, 2019.
Rice, grain.................... 0.50 December 31, 2019.
------------------------------------------------------------------------
* * * * *
[FR Doc. 2016-09969 Filed 5-5-16; 8:45 am]
BILLING CODE 6560-50-P
