[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Rules and Regulations]
[Pages 16301-16307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-6888]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0099; FRL-8863-8]


Flubendiamide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes, modifies and/or revokes 
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-benzenedicarboxamide, in or on 
multiple food and livestock commodities which are identified, and will 
be 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 March 23, 2011. Objections and 
requests for hearings must be received on or before May 23, 2011, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0099. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Registration Division 
(7504P), 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; e-mail address: 
<a href="/cdn-cgi/l/email-protection#1d6f7279747c337e7c6f7078735d786d7c337a726b"><span class="__cf_email__" data-cfemail="760419121f17581517041b13183613061758111900">[email protected]</span></a>.

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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

    Under section 408(g) of 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 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 
May 23, 2011. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2007-0099, by one of the following methods:

[[Page 16302]]

    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 8, 2010 (75 FR 32464 and 32465) 
(FRL-8827-5), EPA issued a notice pursuant to section 408(d)(3) of 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 0F7685) 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 40 
CFR 180.639 be amended by establishing and/or amending 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-benzenedicarboxamide in or on 
artichoke, globe, flower head at 1.6 parts per million (ppm); hog, fat 
at 0.15 ppm; hog, kidney at 0.06 ppm; hog, liver at 0.06 ppm; hog, 
muscle at 0.02 ppm; low growing berry subgroup (crop sub-group 13-07G), 
except cranberry at 1.5 ppm; peanut, hay at 60 ppm; peanut, meal at 
0.032 ppm; peanut, nutmeat at 0.02 ppm; peanut, refined oil at 0.04 
ppm; pistachio at 0.06 ppm; safflower, seed at 4.5 ppm; small fruit 
vine climbing subgroup except fuzzy kiwifruit (crop sub-group 13-07F) 
at 1.4 ppm; sorghum, grain, forage at 13 ppm; sorghum, grain, grain at 
5.0 ppm; sorghum, grain, stover at 18 ppm; sugarcane, cane at 0.30 ppm; 
sunflower, seed at 4.5 ppm; and turnip, greens at 25 ppm and by 
revising existing tolerances for residues of flubendiamide in or on 
alfalfa, forage from 0.15 ppm (rotational crop) to 25 ppm; alfalfa, hay 
from 0.04 ppm (rotational crop) to 65 ppm; brassica, head and stem 
subgroup 5A from 0.60 ppm to 4.0 ppm; brassica, leafy greens subgroup 
5B from 5.0 ppm to 25 ppm; cattle, fat from 0.60 ppm to 0.8 ppm; 
cattle, kidney from 0.60 ppm to 0.4 ppm; cattle, liver from 0.60 ppm to 
0.4 ppm; cattle, muscle from 0.07 ppm to 0.1 ppm; eggs from 0.03 ppm to 
0.7 ppm; goat, fat from 0.60 ppm to 0.8 ppm; goat, kidney from 0.60 ppm 
to 0.4 ppm; goat, liver from 0.60 ppm to 0.4 ppm; goat, muscle from 
0.07 ppm to 0.1 ppm; grain, aspirated fractions from 103 ppm to 215 
ppm; horse, fat from 0.60 ppm to 0.8 ppm; horse, kidney from 0.60 ppm 
to 0.4 ppm; horse, liver from 0.60 ppm to 0.4 ppm; horse, muscle from 
0.07 ppm to 0.1 ppm; milk, fat from 0.80 ppm to 1.0 ppm; poultry, fat 
from 0.15 ppm to 3.0 ppm; poultry, liver from 0.03 ppm to 0.8 ppm; 
poultry, muscle from 0.01 ppm to 0.1 ppm; sheep, fat from 0.60 ppm to 
0.8 ppm; sheep, kidney from 0.60 ppm to 0.4 ppm; sheep, liver from 0.60 
ppm to 0.4 ppm; and sheep, muscle from 0.07 ppm to 0.1 ppm. That notice 
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 at http://www.regulations.gov. There were no substantive comments received in 
response to the notice of filing.
    Based upon review of the data supporting the referenced petition, 
EPA has revised the numerical level for several of the petitioned-for 
tolerances for flubendiamide, and is also revoking several now 
superseded tolerances. The reasons for these changes are explained in 
Unit IV.C.

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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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. The first human health risk assessment for flubendiamide 
(April 3, 2008) was conducted for uses on corn, cotton, tobacco, tree 
fruit, tree nuts, vine crops, and vegetable crops. Since that time, no 
new toxicology data has been submitted to the Agency. The following 
summary represents all the salient features regarding hazard 
characterization and endpoint selection for flubendiamide.
    Flubendiamide has a low acute toxicity via the oral, dermal and 
inhalation 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.

[[Page 16303]]

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 (LOC) 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 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) (a = acute, c = chronic) 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 toxicological endpoints for flubendiamide used for 
human risk assessment is shown in Table 1 of this unit.

Table 1--Summary of Toxicological Doses and Endpoints for Flubendiamide for Use in Human Health Risk Assessments
----------------------------------------------------------------------------------------------------------------
                                      Point of departure and      RfD, PAD, LOC for     Study and toxicological
         Exposure/scenario          uncertainty/safety factors     risk assessment              effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females, 13-49       NOAEL = 99.5 milligrams/    aRfD = 0.995 mg/kg/    2-generation
 years of age).                      kilograms/day (mg/kg/day).  day.                   reproduction, 1-
                                    UFA = 10x.................  aPAD = 0.995 mg/kg/     generation reproduction,
                                    UFH = 10x.................   day.                   and DNT studies as three
                                    FQPA SF = 1x..............                          co-critical studies
                                                                                        (using 1,200 ppm 99.5 mg/
                                                                                        kg/day from the DNT as
                                                                                        the 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.
Acute Dietary (General Population,  ..........................
 including infants and children).
Chronic Dietary (General            NOAEL= 2.4 mg/kg/day......  cRfD = 0.024 mg/kg/    2-year rat cancer study,
 Population, including infants and  UFA = 10x.................   day.                   1-year chronic dog
 children).                         UFH = 10x.................  cPAD = 0.024 mg/kg/     study, and 1-year
                                    FQPA SF = 1x..............   day.                   chronic rat study as
                                                                                        three co-critical
                                                                                        studies, using the
                                                                                        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.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor.

    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 dietary (food and 
drinking water) exposure assessments were conducted using the Dietary 
Exposure Evaluation Model, Version 2.03--Food Commodity Intake Database 
(DEEM-FCID\TM\) which uses food consumption information from the United 
States Department of Agriculture's (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). EPA assessed 
dietary exposures from flubendiamide in food for the proposed new uses 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments

[[Page 16304]]

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 DEEM-
FCID<SUP>TM</SUP> along with food consumption information from the USDA 
1994-1996 and 1998 CSFII. 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 DEEM-FCID<SUP>TM</SUP> along with the food 
consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue 
levels in food, EPA assumed a subset of the currently registered crops 
contain 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 cancer dietary exposure 
assessment for the purpose of assessing cancer risk is unnecessary for 
flubendiamide, and was not conducted.
    iv. Anticipated residue 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/oppefed1/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. The Agency has 
completed a drinking water assessment for flubendiamide using screening 
level water exposure models that were based on the existing and 
proposed uses. For the 1-in-10-year peak, the highest Tier 2 Pesticide 
Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) 
Estimated Drinking Water Concentrations (EDWC) for flubendiamide was 
24.57 parts per billion (ppb), based on application to corn. For the 1-
in-10-year annual average, the highest PRZM/EXAMS EDWC was 11.46 ppb, 
also based on application to corn.
    A summary of the dietary exposure from drinking water for 
flubendiamide used for human risk assessment can be found in the 
documents entitled, ``Flubendiamide: Human Health Risk Assessment for 
Proposed Uses on Alfalfa, Globe Artichokes, the Low Growing Berry 
Subgroup 13-07G (except Cranberry), Peanuts, Pistachios, the Small 
Fruit Vine Climbing (except Fuzzy Kiwifruit) Subgroup 13-07F, 
Safflower, Sorghum, Sugarcane, Sunflower, and Turnip Greens, and an 
Increased Application Rate for Brassica (Cole) Leafy Vegetables,'' 
dated November 30, 2010, 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 page 27 of 62.
    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 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 pre-natal susceptibility, adverse eye 
effects (eye enlargement) were noted in post-natal 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 post-natal days 5 to 20, neonatal rats 
appear to have an increased susceptibility to flubendiamide exposure as 
compared to adults.

[[Page 16305]]

    In addition to the reported eye effects in the DNT study, there was 
also a balano-preputial 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 post-natal 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 1x. 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 acutely, developmentally and incorporated within 
the chronic rat study. 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. There are no treatment-related neurotoxic findings in the acute 
neurotoxicity and DNT studies in rats; although eye effects were 
observed in the DNT study. As noted in Unit III.B., the PODs employed 
in the risk assessment are protective of this effect.
    iii. 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.
    iv. 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 average residue levels found 
in the crop field trials/livestock commodities and both assume 100% of 
crops with requested uses of flubendiamide are treated. The drinking 
water assessment generated 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 
aPAD and 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 data 
summarized and referenced in Unit III.A., flubendiamide has been 
classified as ``Not Likely to be Carcinogenic to Humans,'' and 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; e-mail address: <a href="/cdn-cgi/l/email-protection#245641574d4051414941504c4b4057644154450a434b52"><span class="__cf_email__" data-cfemail="1b697e68727f6e7e767e6f73747f685b7e6b7a357c746d">[email protected]</span></a>.

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 section 
408(b)(4) of FFDCA.

[[Page 16306]]

The Codex Alimentarius is a joint U.N. 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, section 408(b)(4) of FFDCA requires that EPA explain the 
reasons for departing from the Codex level. There are currently no MRLs 
established by Codex, Canada, or Mexico for flubendiamide.

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:
    Based upon review of the data supporting PP 0F7685, recalculated 
beef and dairy cattle, swine, and poultry dietary burdens, and re-
evaluation of previously submitted animal feeding studies, EPA has 
determined that the established tolerances for residues of 
flubendiamide for milk fat, and the meat and fat of cattle, goat, horse 
and sheep should be increased to 1.0 ppm, 0.08 ppm and 0.70 ppm, 
respectively. For swine (hog), EPA has determined that the proposed 
tolerances for hog, fat at 0.15 ppm; hog, kidney at 0.06 ppm; hog, 
liver at 0.06 ppm; and hog, muscle at 0.02 ppm should be established as 
permanent tolerances for residues of flubendiamide in or on hog, fat at 
0.15 ppm, and the proposed tolerances for hog, kidney; hog, liver; and 
hog, muscle should be increased and established as permanent tolerances 
for residues of flubendiamide in or on hog, meat and hog, meat 
byproducts; at 0.15 ppm and 0.03 ppm, respectively. For poultry, EPA 
has determined that the established tolerances for eggs, fat, liver and 
meat should be increased to 0.40 ppm, 3.0 ppm, 0.60 ppm and 0.10 ppm, 
respectively.
    As part of this regulation, permanent tolerances for residues of 
flubendiamide in or on alfalfa, forage (25 ppm) and alfalfa, hay (65 
ppm) resulting from direct application to the primary crop are being 
established. These tolerances supersede the currently listed tolerances 
for indirect or inadvertent residues of flubendiamide in or on alfalfa, 
forage (0.15 ppm) and alfalfa, hay (0.04 ppm), and; therefore, the 
indirect/inadvertent residue tolerances are being revoked from 40 CFR 
180.639(d).

V. Conclusion

    Therefore, new tolerances are being established 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-
benzenedicarboxamide], in or on artichoke, globe at 1.6 parts per 
million (ppm); berry, low growing, subgroup 13-07G, except cranberry at 
1.5 ppm; fruit, small vine climbing except fuzzy kiwifruit, subgroup 
13-07F at 1.4 ppm; hog, fat at 0.15 ppm; hog, meat byproducts at 0.15 
ppm; hog, meat at 0.03 ppm; peanut, hay at 60 ppm; peanut, meal at 0.03 
ppm; peanut, nutmeat at 0.02 ppm; peanut, refined oil at 0.03 ppm; 
pistachio at 0.06 ppm; safflower, seed at 5.0 ppm; sorghum, grain, 
forage at 12 ppm; sorghum, grain, grain at 5.0 ppm; sorghum, grain, 
stover at 14 ppm; sugarcane, cane at 0.30 ppm; sunflower, seed at 5.0 
ppm; and turnip, greens at 25 ppm.
    The established tolerances for residues of flubendiamide for milk 
fat, and the meat and fat of cattle, goat, horse and sheep are being 
increased to 1.0 ppm, 0.08 ppm and 0.70 ppm, respectively. For poultry, 
the established tolerances for eggs, fat, liver and meat are being 
increased to 0.40 ppm, 3.0 ppm, 0.60 ppm and 0.10 ppm, respectively.
    The established tolerances for residues of flubendiamide for 
brassica, head and stem, subgroup 5A; brassica, leafy greens, subgroup 
5B; and grain, aspirated grain fractions are being increased to 3.0 
ppm, 25 ppm, and 153 ppm, respectively.
    The established tolerances for indirect or inadvertent residues of 
flubendiamide in or on alfalfa, forage (0.15 ppm) and alfalfa, hay 
(0.04 ppm) are being revoked from 40 CFR 180.639(d), and established as 
permanent tolerances, in 40 CFR 180.639(a)(2), for residues of 
flubendiamide in or on alfalfa, forage at 25 ppm; and alfalfa, hay at 
65 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides

[[Page 16307]]

that before a rule may take effect, the agency promulgating the rule 
must submit a rule report to each House of the Congress and to the 
Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: March 15, 2011.
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 revised to read as follows:


Sec.  180.639  Flubendiamide; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide flubendiamide per se 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
------------------------------------------------------------------------
Almond, hulls..............................................          9.0
Apple, wet pomace..........................................          2.0
Corn, field, forage........................................          8.0
Corn, field, grain.........................................         0.03
Corn, field, stover........................................           15
Corn, pop, grain...........................................         0.02
Corn, pop, stover..........................................           15
Corn, sweet, forage........................................          9.0
Corn, sweet, kernel plus cob with husks removed............         0.01
Corn, sweet, stover........................................           25
Cotton gin byproducts......................................           60
Cotton, undelinted seed....................................         0.90
Fruit, pome, group 11......................................         0.70
Fruit, stone, group 12.....................................          1.6
Grape......................................................          1.4
Nut, tree, group 14........................................         0.06
Okra.......................................................         0.30
Vegetable, cucurbit, group 9...............................         0.20
Vegetable, fruiting, group 8...............................         0.60
Vegetable, leafy, except Brassica, group 4.................           11
------------------------------------------------------------------------

     (2) 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
------------------------------------------------------------------------
Alfalfa, forage............................................           25
Alfalfa, hay...............................................           65
Artichoke, globe...........................................          1.6
Berry, low growing, subgroup 13-07G, except cranberry......          1.5
Brassica, head and stem, subgroup 5A.......................          3.0
Brassica, leafy greens, subgroup 5B........................           25
Cattle, fat................................................         0.70
Cattle, meat...............................................         0.60
Cattle, meat byproducts....................................         0.08
Egg........................................................         0.40
Fruit, small fruit vine climbing except fuzzy kiwifruit,             1.4
 subgroup 13-07F...........................................
Goat, fat..................................................         0.70
Goat, meat.................................................         0.60
Goat, meat byproducts......................................         0.08
Grain, aspirated grain fractions...........................          153
Hog, fat...................................................         0.15
Hog, meat..................................................         0.15
Hog, meat byproducts.......................................         0.03
Horse, fat.................................................         0.70
Horse, meat................................................         0.60
Horse, meat byproducts.....................................         0.08
Milk.......................................................         0.15
Milk, fat..................................................          1.0
Pea and bean, dried shelled, except soybean, subgroup 6C...         0.60
Pea and bean, succulent shelled, subgroup 6B...............         0.05
Peanut, hay................................................           60
Peanut, meal...............................................         0.03
Peanut, nutmeat............................................         0.02
Peanut, refined oil........................................         0.03
Pistachio..................................................         0.06
Poultry, fat...............................................          3.0
Poultry, liver.............................................         0.60
Poultry, meat..............................................         0.10
Rice, grain \1\............................................         0.50
Safflower, seed............................................          5.0
Sheep, fat.................................................         0.70
Sheep, meat................................................         0.60
Sheep, meat byproducts.....................................         0.08
Sorghum, grain, forage.....................................           12
Sorghum, grain, grain......................................          5.0
Sorghum, grain, stover.....................................           14
Soybean, forage............................................           18
Soybean, hay...............................................           60
Soybean, hulls.............................................         0.80
Soybean, seed..............................................         0.25
Sugarcane, cane............................................         0.30
Sunflower, seed............................................          5.0
Turnip, greens.............................................           25
Vegetable, foliage of legume, except soybean, subgroup 7A..           35
Vegetable, legume, edible podded, subgroup 6A..............         0.50
------------------------------------------------------------------------
\1\ There are no U.S. registrations for rice, grain.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established 
for residues of the insecticide flubendiamide per se 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 raw agricultural commodities when present 
therein as a result of the application of flubendiamide to the growing 
crops listed in paragraph (a)(1) of this section:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, hay................................................         0.04
Barley, straw..............................................         0.07
Buckwheat..................................................         0.07
Clover, forage.............................................         0.15
Clover, hay................................................         0.04
Grass, forage..............................................         0.15
Grass, hay.................................................         0.04
Millet, pearl, forage......................................         0.15
Millet, pearl, hay.........................................         0.04
Millet, proso, forage......................................         0.15
Millet, proso, hay.........................................         0.04
Millet, proso, straw.......................................         0.07
Oats, forage...............................................         0.15
Oats, hay..................................................         0.04
Oats, straw................................................         0.07
Rye, forage................................................         0.15
Rye, straw.................................................         0.07
Teosinte, forage...........................................         0.15
Teosinte, hay..............................................         0.04
Teosinte, straw............................................         0.07
Triticale, forage..........................................         0.15
Triticale, hay.............................................         0.04
Triticale, straw...........................................         0.07
Wheat, forage..............................................         0.15
Wheat, hay.................................................         0.03
Wheat, straw...............................................         0.03
------------------------------------------------------------------------

[FR Doc. 2011-6888 Filed 3-22-11; 8:45 am]
BILLING CODE 6560-50-P


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