[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Rules and Regulations]
[Pages 73940-73945]
[FR Doc No: 2012-29979]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0099; FRL-9373-3]

Flubendiamide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation modifies tolerances for residues of
flubendiamide in or on multiple food commodities which are identified,
and discussed in detail later in this document. Bayer CropScience LP in
c/o Nichino America, Inc. (U.S. subsidiary of Nihon Nohyaku Co., Ltd.)
requested these tolerances, and revisions to tolerances under the
Federal Food, Drug and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 12, 2012. Objections and
requests for hearings must be received on or before February 11, 2013,
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-2007-0099, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Avenue NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/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-2007-0099 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
February 11, 2013. 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-2007-0099, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 23, 2012 (77 FR 30481) (FRL-9347-8),
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 2F7981)
by Bayer CropScience LP in c/o Nichino America, Inc. (U.S. subsidiary
of Nihon Nohyaku Co., Ltd.), P.O. Box 12014, Research Triangle Park, NC
27709-2014. The petition requested that the established tolerances
listed in 40 CFR 180.639 for residues of the insecticide flubendiamide,
N\2\-[1, 1-dimethyl-2-(methylsulfonyl)ethyl]-3-iodo-N\1\-[2-methyl-4-
[l, 2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-
benzenedicarboxamide, in or on Apple, wet pomace be increased from 2.0
parts per million (ppm) to 5.0 ppm; and Fruit, pome, group 11 be
increased from 0.70 ppm to 1.5 ppm. That document

referenced a summary of the petition prepared by Bayer CropScience LP
in c/o Nichino America, Inc. (U.S. subsidiary of Nihon Nohyaku Co.,
Ltd.), the registrant, which is available in the docket, http://www.regulations.gov. There were no substantive 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 flubendiamide including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with flubendiamide
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.
    Flubendiamide has a low acute toxicity via the oral and dermal
routes of exposure. Though it is a slight irritant to the eye,
flubendiamide is not a skin irritant and it is not a skin sensitizer
under the conditions of the guinea pig maximization test.
    In the mammalian toxicology database, the primary target organ of
flubendiamide exposure is the liver, with secondary effects reported in
the thyroid and kidney at equivalent or higher doses; no-observed-
adverse-effect-levels (NOAELs) established to protect for liver
toxicity are protective of effects seen in the thyroid and kidney.
Adverse adrenal effects were also noted in the dog.
    Buphthalmia (eye enlargement), opacity, and exophthalmus with
hemorrhage appearing only in infancy, were observed in rat offspring in
the reproductive and developmental neurotoxicity (DNT) studies. There
was no clear dose-response relationship for this effect, but ocular
toxicity was noted in three rat studies and accompanied by
histopathological findings of synechia, hemorrhage, keratitis, iritis,
and cataracts. Therefore, bupthalmos is considered an effect of
treatment. No evidence of cancer was seen for flubendiamide in cancer
bioassays in mice and rats. Flubendiamide was also negative in
mutagenicity testing. Accordingly, flubendiamide was classified as
``Not Likely To Be Carcinogenic to Humans.''
    More detailed information on the studies received and the nature of
the adverse effects caused by flubendiamide as well as the NOAEL and
the lowest-observed-adverse effect-level (LOAEL) from the toxicity
studies can be found in the document entitled, ``Flubendiamide: Human
Health Risk Assessment for Proposed Uses on Corn, Cotton, Tobacco, Tree
Fruit, Tree Nuts, Vine Crops and Vegetable Crops,'' dated April 3,
2008, by going to http://www.regulations.gov. The referenced document
is available in the docket established by this action, which is
described under ADDRESSES. Locate and click on the hyperlink for docket
ID number EPA-HQ-OPP-2007-0099. Double-click on the document to view
the referenced information on pages 65-70 of 105.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for flubendiamide used for
human risk assessment is shown in the following Table 1.

 Table 1--Summary of Toxicological Doses and Endpoints for Flubendiamide for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute Dietary (Females, 13-49      NOAEL = 99.5 mg/kg/   aRfD = 0.995 mg/kg/  2-generation reproduction, 1-
 years of age).                     day.                  day.                 generation reproduction, and DNT
                                   UFA = 10x...........  aPAD = 0.995 mg/kg/   studies as three co-critical
Acute Dietary (General             UFH = 10x...........   day.                 studies (using 1,200 ppm [99.5 mg/
 Population, including infants     FQPA SF = 1x........                        kg/day] from the DNT as the
 and children)..                                                               highest NOAEL for eye effects and
                                                                               a LOAEL from the 1-generation
                                                                               reproduction study of 127 mg/kg/
                                                                               day), based on buphthalmia
                                                                               (enlargement of eyes), ocular
                                                                               opacity, retinal degeneration,
                                                                               hemorrhage, cataract, and atrophy
                                                                               of the optic nerve.

Chronic Dietary (General           NOAEL = 2.4 mg/kg/    cRfD = 0.024 mg/kg/  2-year rat cancer study, 1-year
 Population, including infants      day.                  day.                 chronic dog study, and 1-year
 and children).                    UFA = 10x...........  cPAD = 0.024 mg/kg/   chronic rat study as three co-
                                   UFH = 10x...........   day.                 critical studies, using the
                                   FQPA SF = 1x........                        chronic rat study NOAEL of 50 ppm
                                                                               (2.4 mg/kg/day) with LOAEL from
                                                                               the 2-year cancer rat study of
                                                                               33.9 mg/kg/day, based on liver
                                                                               toxicity, fatty change,
                                                                               hypertrophy, [uarr] liver weight
                                                                               and [uarr] Gamma Glutamyl
                                                                               Transferase (GGT).
                                  ------------------------------------------------------------------------------
Cancer (oral, dermal, and            Classification: Not likely to be carcinogenic to humans based on negative
 inhalation).                         genotoxicity and carcinogenicity in long-term cancer studies in rats and
                                                                        mice.
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FQPA SF = Food Quality Protection Act Safety Factor. milligrams/kilograms/day = mg/kg/day. UFA = extrapolation
  from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
  population (intraspecies). Reference dose. Population adjusted dose. (a = acute; c = chronic). DNT =
  developmental neurotoxicity test.

    A summary of the toxicological endpoints for flubendiamide used for
human risk assessment can be found in the document entitled,
``Flubendiamide: Human Health Risk Assessment for Proposed Uses on
Corn, Cotton, Tobacco, Tree Fruit, Tree Nuts, Vine Crops and Vegetable
crops,'' dated April 3, 2008, by going to http://www.regulations.gov.
The referenced document is available in the docket established by this
action, which is described under ADDRESSES. Locate and click on the
hyperlink for docket ID number EPA-HQ-OPP-2007-0099. Double-click on
the document to view the referenced information on pages 37-38 of 105.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flubendiamide, EPA considered exposure under the
petitioned-for tolerances as well as all existing flubendiamide
tolerances in 40 CFR 180.639. Acute and chronic aggregate dietary (food
and drinking water) exposure and risk assessments were conducted using
the Dietary Exposure Evaluation Model, Version 3.16--Food Commodity
Intake Database (DEEMFCIDTM) which uses food consumption
information from the U.S. Department of Agriculture's (USDA's) National
Health and Nutrition Examination Survey, What We Eat In America
(NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008.
The analyses were performed to support Section 3 requests for increases
in the tolerances for pome fruit and wet apple pomace as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for flubendiamide. In estimating acute dietary exposure, EPA used
DEEMFCIDTM along with food consumption information from the
USDA's 2003-2008 NHANES/WWEIA survey. As to residue levels in food, for
the acute assessment, the modeled exposure estimates are based on
tolerance level residues, assuming 100% of crops were treated. In
addition, experimental processing (where available) factors were
assumed for both registered and requested crop uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's 2003-2008
NHANES/WWEIA survey. EPA assumed a subset of the currently registered
crops contains residues at the average residue levels found in the crop
field trials. For the newly proposed crops, livestock commodities, and
the remaining currently registered crops, EPA assumed tolerance level
residues. In addition, experimental processing factors were used where
available. Finally, EPA assumed 100% of crops were treated.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that flubendiamide should be classified as ``Not Likely To Be
Carcinogenic to Humans.'' As a result, a dietary exposure assessment
for the purpose of assessing cancer risk is unnecessary for
flubendiamide, and was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require,
pursuant to FFDCA section 408(f)(1), that data be provided 5 years
after the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used Tier II
screening level water exposure models in the dietary exposure analysis
and risk assessment for flubendiamide in drinking water. These
simulation models take into account data on the physical, chemical and
fate/transport characteristics of flubendiamide. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefedl/models/water/index.htm.
    Flubendiamide is persistent and potentially mobile in terrestrial
and aquatic environments. These fate properties suggest that it has a
potential to move into surface water and ground water. Potential
residues in drinking water were included in the acute and chronic
dietary analyses based on surface water results from the Tier II,
Pesticide Root Zone Modeling/Exposure Analysis Modeling System(PRZM/
EXAMS) Index Reservoir model as these values were higher than the
groundwater estimates from the Screening Concentration in Ground Water
(SCI-GROW) model. Estimated acute and chronic drinking water values
were 24.57 parts per billion (ppb) and 11.46 ppb, respectively.
    A summary of the dietary exposure from drinking water for
flubendiamide used for human risk assessment can be found in the
documents entitled, ``Flubendiamide: Acute and Chronic Aggregate
Dietary (Food and Drinking

Water) Exposure Assessment for the Increased Tolerance on Pome Fruit,''
dated September 11, 2012, by going to http://www.regulations.gov. The
referenced document is available in the docket established by this
action, which is described under ADDRESSES. Locate and click on the
hyperlink for docket ID number EPA-HQ-OPP-2007-0099. Double-click on
the document to view the referenced information on pages 2-4 of 29.
    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). Flubendiamide is not
registered for any specific use patterns that would result in
residential exposure.
    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 flubendiamide to share a common mechanism of
toxicity with any other substances, and flubendiamide does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
flubendiamide does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

 D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines, based on reliable data, that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. While both the rat and
rabbit developmental studies did not identify teratogenic effects and
showed no evidence of increased prenatal susceptibility, adverse eye
effects (eye enlargement) were noted in postnatal rat pups older than
14 days in multiple studies (the 2-generation reproduction and 1-
generation supplemental studies). Additionally, the DNT study reported
eye effects appearing in some offspring between lactation days 14 and
42, even though exposure stopped at lactation day 21, indicating a
possible delay (a latent response) from the time of last exposure to
onset of bupthalmos. These eye effects did not occur in adult rats.
Since the iris and chamber angle are differentiating and specializing
into definite structures during postnatal days 5 to 20, neonatal rats
appear to have an increased susceptibility to flubendiamide exposure as
compared to adults.
    In addition to the reported eye effects in the DNT study, there was
also a balanopreputial separation (separation of the prepuce (foreskin)
from the glans penis (balanus)) delay. While this effect is generally
considered adverse per se, it is not assumed to be a developmental
effect from in utero exposure. Here, delayed balano-preputial
separation is considered secondary to reduced postnatal pup body weight
as a result of postnatal exposure. Furthermore, it was resolved within
the appropriate age range of puberty and no effects on reproductive
function were observed in the multigeneration study in rats. Delayed
balanopreputial separation was seen only at doses causing maternal
toxicity and is not more severe than the maternal effects of
hepatotoxicity seen at the common pup/maternal LOAEL of the DNT study.
Accordingly, the delayed balanopreputial separation seen in the DNT
study does not cause concern for increased sensitivity to the young for
flubendiamide.
    Human microsomes have been shown to be capable of approximately 4
times higher hydroxylation rates of flubendiamide as compared to female
mouse microsomes and may be able to efficiently metabolize and excrete
flubendiamide, preventing accumulation of the parent compound. It
remains unclear whether the ability to metabolize and clear the parent
compound is the only requirement to avoid ocular toxicity. Due to the
potential ocular toxicity, this perinatal ocular effect is considered
in the human health risk assessment for flubendiamide.
    3. Conclusion. EPA evaluated the quality of the toxicity and
exposure data and, based on these data, has determined that the safety
of infants and children would be adequately protected if the FQPA SF
were reduced to lX. That decision is based on the following findings:
    i. The toxicology database for flubendiamide is complete with the
exception of a subchronic neurotoxicity study which is now a new data
requirement under 40 CFR part 158; however, the existing data are
sufficient for endpoint selection for exposure/risk assessment
scenarios, and for evaluation of the requirements under the FQPA.
Flubendiamide is not a neurotoxic chemical based on neurotoxicity
assessments conducted in the acute and developmental neurotoxicity
studies and as part of the chronic rat study. Additionally, in several
short-term studies in rats (subacute and subchronic feeding, plaque-
forming cell assay, one-generation pilot, developmental toxicity) no
neurobehavioral signs were observed at doses up to and exceeding the
limit dose; therefore, an additional database uncertainty factor is not
needed to account for potential neurotoxicity.
    ii. Although susceptibility was identified in the toxicological
database (eye effects), the selected regulatory PODs (which are based
on clear NOAELs) are protective of these effects; therefore, the human
health risk assessment is protective.
    iii. There are no residual uncertainties identified in the exposure
databases and the exposure assessment is protective. The acute dietary
food exposure assessment utilizes tolerance-level residues, the chronic
dietary food exposure assessment utilizes, in part, average residue
levels found in the crop field trials/livestock commodities and, in
part, tolerance-level residues. Both assessments assume that 100% of
crops with requested or existing uses of flubendiamide are treated. The
drinking water assessment generated estimated drinking water
concentrations (EDWCs) using models and associated modeling parameters
which are designed to provide conservative, health protective, high-end
estimates of water concentrations. The highest relevant EDWCs were used
in the dietary (food and drinking water) exposure assessment. By using
these screening-level exposure assessments in the acute and chronic
dietary (food and drinking water) assessments, risk is not
underestimated for flubendiamide.

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 population adjusted dose (aPAD) and chronic population adjusted
dose (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.
    For this action, there is potential exposure to flubendiamide from
food and drinking water, but not from residential use sites (as there
are no proposed or existing residential uses for flubendiamide). Since
hazard was identified via the oral route over both the acute and
chronic duration, the aggregate risk assessments considers exposures
from food and drinking water consumed over the acute and chronic
durations.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, EPA has concluded that acute dietary exposure
from food and water to flubendiamide will utilize 3.1% of the aPAD for
the general U.S. population and 5% of the aPAD for the most highly
exposed population subgroup, children aged 1 to 2 years old.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic dietary
exposure to flubendiamide from food and water will utilize 20% of the
cPAD for the general U.S. population and 58% of the cPAD for the most
highly exposed population subgroup, children aged 1 to 2 years old.
There are no proposed or existing residential uses for flubendiamide.
Based on the explanation in Unit III.C.3., regarding residential use
patterns, chronic residential exposure to residues of flubendiamide is
not expected.
    3. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of cancer in cancer bioassays in mice and rat, flubendiamide
is not expected to pose a cancer risk.
    4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general U.S. population or to infants and children from
aggregate exposure to flubendiamide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Liquid Chromatography with tandem
Mass Spectrometry detection ((LC/MS/MS), Methods 00816/M002 and 00912)
is available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Road, Fort Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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, Canadian or Mexican MRLs
for residues of flubendiamide in/on apple, wet pomace or fruit, pome,
group 11 commodities.

C. Revisions to Petitioned-for Tolerances

    The Agency's ``Guidance for Setting Pesticide Tolerances Based on
Field Trial Data,'' was utilized for determining appropriate tolerance
levels for many raw agricultural commodities (RACs) which showed
quantifiable residues in or on samples that were treated according to
the proposed use patterns. The following revisions to tolerance levels
were made:
    The recommended tolerance levels are the same values as in the
petition. The Organization of Economic Coordination and Development
(OECD) calculation procedure was utilized to derive the tolerance
estimate for pome fruit based on all apple field trial data and all
pear field trial data (D386262, S. Funk, 04/01/2011). The new apple
pomace tolerance is derived from the highest average apple field trial
result (1.21 ppm) and the processing factor for conversion of apples to
apple pomace (3.6X) from a previously reviewed study. The proposed
increases in tolerances for pome fruit and wet apple pomace have no
effect on the dietary burdens of livestock. Therefore, the established
tolerances for meat, milk, poultry, and eggs are adequate.

V. Conclusion

    Therefore, the established tolerances for residues of
flubendiamide, N\2\-[1,1-dimethyl-2-(methylsulfonyl)ethyl]-3-iodo-N\1\-
[2-methyl-4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-
benzenedicarboxamidein or on apple, wet pomace is being increased to
5.0 ppm. The established tolerance for fruit, pome, group 11 is being
increased to 1.5 ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
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 final rule 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 final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: December 6, 2012.
Lois Rossi,
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. Section 180.639 is amended as follows:
0
a. In paragraph (a)(1) revise the introductory text and the entries for
``apple, wet pomace,'' and ``fruit, pome, group 11.''
0
b. Revise the introductory text to paragraph (d).
    The revised text reads as follows:

Sec.  180.639  Flubendiamide; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of
flubendiamide, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified in the table is to be determined by measuring only
flubendiamide N\2\-[1, 1-dimethyl-2-(methylsulfonyl)ethyl]-3-iodo-N\1\-
[2-methyl-4- [1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-
benzenedicarboxamide, in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Apple, wet pomace..........................................          5.0

                                * * * * *
Fruit, pome, group 11......................................          1.5
------------------------------------------------------------------------

* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established
for residues of flubendiamide, including its metabolites and
degradates, in or on the commodities in the table below. Compliance
with the tolerance levels specified in the table is to be determined by
measuring only flubendiamide N2-[1, 1-dimethyl-2-
(methylsulfonyl)ethyl]-3-iodo-N1-[2-methyl-4- [1,2,2,2-tetrafluoro-1-
(trifluoromethyl)ethyl]phenyl]-1, 2-benzenedicarboxamide, in or on the
following commodities:
* * * * *
[FR Doc. 2012-29979 Filed 12-11-12; 8:45 am]
BILLING CODE 6560-50-P