Document ID: EPA-HQ-OPP-2007-0099-0038
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Flubendiamide
Posted Date: 2012-12-12T05:00Z

[Federal Register Volume 77, Number 239 (Wednesday, December 12, 2012)]
[Rules and Regulations]
[Pages 73940-73945]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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: (703) 306-0327; fax number: (703) 308-0029; email address: 
rodia.carmen@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at 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

[[Page 73941]]

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.

[[Page 73942]]

 
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

[[Page 73943]]

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.

[[Page 73944]]

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: (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, 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

[[Page 73945]]

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