
[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Rules and Regulations]               
[Page 50914-50922]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18au10-25]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0099; FRL-8836-2]

 
Flubendiamide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes, reassesses, modifies and 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/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 under the Federal Food, Drug and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective August 18, 2010. Objections and 
requests for hearings must be received on or before October 18, 2010, 
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: 
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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     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 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

[[Page 50915]]

must be in writing, and must be received by the Hearing Clerk on or 
before October 18, 2010. 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:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     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 Tolerances

    In the Federal Register of March 19, 2010 (75 FR 13277-13280) (FRL-
8813-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
9F7553, 9E7554 and 9F7555) 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 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/on pea and bean, succulent shelled, 
subgroup 6B at 0.04 parts per million (ppm); pea and bean, dried 
shelled, except soybean, subgroup 6C at 0.80 ppm; rice, grain at 0.50 
ppm (PP 9E7554); soybean, aspirated grain fractions at 91 ppm; soybean, 
forage at 18 ppm; soybean, hay at 60 ppm; soybean, hulls at 0.70 ppm; 
soybean, seed at 0.25 ppm; vegetable, foliage of legume, except 
soybean, subgroup 7A at 35 ppm; vegetable, legume, edible podded, 
subgroup 6A at 0.50 ppm; and rice, straw as a rotational crop at 0.07 
ppm (PP 9F7555). That notice referenced a summary of the petitions 
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. 
Based upon review of the data supporting these petitions, EPA has 
reassessed, modified and revoked some of the existing tolerances for 
flubendiamide. In addition, EPA has also determined that in primary and 
rotational crops, the residue of concern for both the tolerance 
expression and risk assessment is flubendiamide. In livestock, the 
residue of concern for tolerance expression is flubendiamide. The 
reason for these changes is explained in Unit IV.D.

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 the petitioned-for 
tolerances for residues of flubendiamide in/on pea and bean, dried 
shelled, except soybean, subgroup 6C; pea and bean, succulent shelled, 
subgroup 6B; rice, grain; soybean, aspirated grain fractions; soybean, 
forage; soybean, hay; soybean, hulls; soybean, seed; vegetable, foliage 
of legume, except soybean, subgroup 7A; vegetable, legume, edible 
podded, subgroup 6A; and rice, straw as a rotational crop. 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, 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 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

[[Page 50916]]

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 to 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 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 to 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 (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 on legume 
vegetables, soybeans and a tolerance on imported rice 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 DEEM-
FCID\TM\ 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, default 
processing factors were assumed for both registered and requested crop 
uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used DEEM-FCID\TM\ along with the food consumption data 
from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, 
EPA assumed all currently registered crops contain residues at the 
average residue levels found in the crop field trials. For the newly 
proposed crops and for livestock commodities, EPA assumed tolerance 
level residues. In addition, experimental processing factors were used 
where available. Finally, EPA assumed 100% of crops were treated.
    iii. Cancer. As explained above, flubendiamide is considered to be 
``Not Likely to be Carcinogenic to Humans.'' As a result, cancer 
exposure assessment is not needed for flubendiamide.
    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 section 408(f)(1) of 
FFDCA 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 section 408(b)(2)(E) of 
FFDCA and authorized under section 408(f)(1) of FFDCA. Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    More detailed information on the acute and chronic aggregate 
dietary assessment for flubendiamide used for human risk assessment can 
be found in the document entitled, ``Flubendiamide: Acute and Chronic 
Aggregate Dietary (Food and Drinking Water) Exposure and Risk 
Assessments for the Proposed Section 3 Registration Action on Legume 
Vegetables and Soybeans and a Tolerance on Imported Rice,'' dated March 
31, 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 pages 10 to 11 of 26.
    2. Dietary exposure from drinking water. The Agency used 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 and ground water. The Agency has 
completed a drinking water assessment for flubendiamide using screening 
level water exposure models that were based on the proposed new uses on 
legume vegetables, rice grain and Christmas trees. Based on the 
modeling analysis performed for the proposed new uses, the estimated 
drinking water concentrations (EDWCs) are less than the reported values 
previously assessed for the existing uses. For the 1 in 10 year peak, 
the highest Tier 2 Pesticide Root Zone Model /Exposure Analysis 
Modeling System (PRZM/EXAMS) EDWC for flubendiamide was 12.93 [mu]g/L 
(approx.

[[Page 50917]]

13 [mu]g/L), based on application to Illinois corn. For the 1 in 10 
year annual average, the highest PRZM/EXAMS EDWC was 11.95 [mu]g/L 
(approx. 12 [mu]g/L), also based on application to Illinois 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 Legume Vegetables, Soybeans and Christmas Trees, and 
to Establish a Tolerance on Imported Rice Grain,'' dated April 30, 
2010, ``Amendment: Flubendiamide: Human Health Risk Assessment for 
Proposed Uses on Legume Vegetables, Soybeans and Christmas Trees, and 
to Establish a Tolerance on Imported Rice Grain,'' dated June 28, 2010, 
and ``Flubendiamide: Bridging Residue Study Conducted with an Adjuvant 
in Support of Proposed Uses on Soybeans and Legumes,'' dated July 13, 
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 pages 25 to 26 of 56.
    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. That is, no residential uses are 
being requested for flubendiamide at this time; therefore, no 
residential risk assessment has been conducted.
    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 website 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. Pre-natal and post-natal 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 developmental 
neurotoxicity (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. The DNT study also reported that pre-mating exposures are not 
required to elicit the eye effect in pups.
    In addition to the reported eye effects in the DNT study, there was 
also a balanopreputial seperation (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 balanopreputial separation 
is considered secondary to reduced post-natal pup body weight as a 
result of post-natal exposure. Futhermore, 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 concern for increased susceptibility of the human neonate 
compared to adults, 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. 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.

[[Page 50918]]

    iii. 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 above, the PODs employed in the 
risk assessment are protective of this effect.
    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 assessment 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, the acute dietary exposure from food and water 
to flubendiamide will occupy less than 7% of the aPAD for the mostly 
highly exposed population subgroup, children aged 1-2 years old.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
flubendiamide from food and water will utilize 40% of the cPAD for the 
mostly highly exposed population subgroup, children aged 1-2 years old. 
There are no proposed or existing residential uses for flubendiamide.
    3. Aggregate cancer risk for U.S. population. Based on the evidence 
discussed above, 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 population or to infants and children from aggregate 
exposure to flubendiamide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (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: 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 section 
408(b)(4) of FFDCA. 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 established Codex, Canadian or Mexican MRLs 
for residues of flubendiamide in/on various food or livestock 
commodities.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting PP 9F7553, 9E7554 and 
9F7555, EPA has determined that in primary and rotational crops, the 
residue of concern for both the tolerance expression and risk 
assessment is flubendiamide. In livestock, the residue of concern for 
tolerance expression is flubendiamide; the residues of concern in 
livestock for risk assessment are flubendiamide and metabolite A14. EPA 
is creating a separate subsection in the flubendiamide tolerance 
section (paragraph (a)(2)) for the new tolerances and animal tolerances 
affected by the new tolerances that reflects this determination on the 
appropriate tolerance expression. The new subsection makes clear that, 
as provided by section 408 of FFDCA, the tolerance covers flubendiamide 
metabolites and degradates.
    The Agency's Guidance for Setting Pesticide Tolerances Based on 
Field Trial Data was utilized for determining appropriate tolerance 
levels for many RACs which showed quantifiable residues in or on 
samples that were treated according to the proposed use patterns. Many 
of the assessed RAC tolerances are consistent with the levels proposed 
by the petitioner.
    EPA generally establishes a generic tolerance for ``aspirated grain 
fractions'' based on uses of a pesticide on corn, wheat, sorghum and 
soybean. If the pesticide is used on several crops, the RAC with the 
highest residues in aspirated grain fractions will be used to establish 
the tolerance. Residue data for the aspirated grain fractions of field 
corn were reviewed in PP 6F7065, which led to the establishment of the 
current 5.0 ppm tolerance for aspirated grain fractions. Based on the 
registered use on field corn, and the proposed use on soybeans, EPA has 
determined that the established tolerance for aspirated grain fractions 
be revised from 5.0 ppm to 103 ppm.
    As part of this regulation, permanent tolerances for residues of 
flubendiamide in or on soybean forage (18 ppm) and soybean hay (60 ppm) 
resulting from direct application to the primary crop are established. 
These tolerances supersede the currently listed tolerances for indirect 
or inadvertent residues of flubendiamide in/on soybean forage (0.02 
ppm) and soybean hay (0.04 ppm), and therefore the indirect/inadvertent 
residue tolerances are being revoked from 40 CFR 180.639(d).
    The established tolerances for meat, milk, poultry and eggs were 
also reassessed in light of the recalculated beef and dairy cattle, 
swine and poultry dietary burdens and following consideration of the 
newly-proposed uses and reevaluation of previously submitted animal 
feeding studies. The Agency concludes that the established

[[Page 50919]]

tolerances for residues of flubendiamide for milk, milk fat, meat 
byproducts (previously listed as liver and kidney separately), meat and 
fat of cattle, goat, horse and sheep should be increased to 0.15 ppm, 
0.80 ppm, 0.60 ppm, 0.07 ppm and 0.60 ppm, respectively. For swine, EPA 
concludes that tolerances need to be added on meat byproducts at 0.01 
ppm and on fat at 0.01 ppm. For poultry, EPA concludes that the 
established tolerance for meat (0.01 ppm) remains adequate; however, 
tolerances for egg, fat and liver need to be raised to 0.03 ppm, 0.15 
ppm and 0.03 ppm, respectively.
    The submitted Section F of the rice petition does not include any 
tolerance proposal on rice straw (PP 9F7555). Rice straw is not a 
significant livestock feedstuff as per Table 1 of Guideline 860.1000; 
therefore, a rotational crop tolerance on rice straw is not needed and 
will not be approved as part of this regulation.

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/on grain, aspirated grain fractions at 103 
ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 0.60 
ppm; pea and bean, succulent shelled, subgroup 6B at 0.05 ppm; rice, 
grain at 0.50 ppm; soybean, forage at 18 ppm; soybean, hay at 60 ppm; 
soybean, hulls at 0.80 ppm; soybean, seed at 0.25 ppm; vegetable, 
foliage of legume, except soybean, subgroup 7A at 35 ppm; and 
vegetable, legume, edible podded, subgroup 6A at 0.50 ppm.
    The established tolerances for residues of flubendiamide for milk, 
milk fat, meat byproducts (previously listed as liver and kidney 
separately), meat and fat of cattle, goat, horse and sheep are being 
increased to 0.15 ppm, 0.80 ppm, 0.60 ppm, 0.07 ppm and 0.60 ppm, 
respectively. Additionally, the extablished tolerances for egg, fat and 
liver are being increased to 0.03 ppm, 0.15 ppm and 0.03 ppm, 
respectively.
    The established tolerances on liver (0.30 ppm) and kidney (0.30 
ppm) for cattle, goat, horse and sheep, listed in 40 CFR 180.639(a), 
are being superseded by renamed tolerances for meat byproducts for 
cattle, goat, horse and sheep (0.60 ppm) in the newly created 
subsection, 40 CFR 180.639(a)(2). The established tolerances for 
indirect or inadvertent residues of flubendiamide in/on soybean, forage 
(0.02 ppm) and soybean, hay (0.04 ppm) are being revoked from 40 CFR 
180.639(d), and are being superseded by the new soybean and legume 
vegetable tolerances listed in 40 CFR 180.639(a)(2).

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) (Public Law 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 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: August 10, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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:

[[Page 50920]]



----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Almond, hulls                                                                                            9.0 ppm
----------------------------------------------------------------------------------------------------------------
Apple, wet pomace                                                                                        2.0 ppm
----------------------------------------------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A                                                                    0.60 ppm
----------------------------------------------------------------------------------------------------------------
Brassica, leafy greens, subgroup 5B                                                                      5.0 ppm
----------------------------------------------------------------------------------------------------------------
Corn, field, forage                                                                                      8.0 ppm
----------------------------------------------------------------------------------------------------------------
Corn, field, grain                                                                                      0.02 ppm
----------------------------------------------------------------------------------------------------------------
Corn, field, stover                                                                                     0.15 ppm
----------------------------------------------------------------------------------------------------------------
Corn, sweet, forage                                                                                      9.0 ppm
----------------------------------------------------------------------------------------------------------------
Corn, sweet, kernel plus cob with husks removed                                                         0.01 ppm
----------------------------------------------------------------------------------------------------------------
Corn, sweet, stover                                                                                     0.25 ppm
----------------------------------------------------------------------------------------------------------------
Cotton gin byproducts                                                                                   0.60 ppm
----------------------------------------------------------------------------------------------------------------
Cotton, undelinted seed                                                                                 0.90 ppm
----------------------------------------------------------------------------------------------------------------
Fruit, pome, group 11                                                                                   0.70 ppm
----------------------------------------------------------------------------------------------------------------
Fruit, stone, group 12                                                                                   1.6 ppm
----------------------------------------------------------------------------------------------------------------
Grape                                                                                                    1.4 ppm
----------------------------------------------------------------------------------------------------------------
Nut, tree, group 14                                                                                     0.06 ppm
----------------------------------------------------------------------------------------------------------------
Okra                                                                                                    0.30 ppm
----------------------------------------------------------------------------------------------------------------
Vegetable, cucurbit, group 9                                                                            0.20 ppm
----------------------------------------------------------------------------------------------------------------
Vegetable, fruiting, group 8                                                                            0.60 ppm
----------------------------------------------------------------------------------------------------------------
Vegetable, leafy, except Brassica, group 4                                                                11 ppm
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------

    (2) Tolerances are established for residues of flubendiamide, 
including its metabolites and degradates, in or on the commodities 
listed in the table below. Compliance with the tolerance levels 
specified below 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:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Cattle, fat                                                                                             0.60 ppm
----------------------------------------------------------------------------------------------------------------
Cattle, meat byproducts                                                                                 0.60 ppm
----------------------------------------------------------------------------------------------------------------
Cattle, meat                                                                                            0.07 ppm
----------------------------------------------------------------------------------------------------------------
Eggs                                                                                                    0.03 ppm
----------------------------------------------------------------------------------------------------------------
Goat, fat                                                                                               0.60 ppm
----------------------------------------------------------------------------------------------------------------
Goat, meat byproducts                                                                                   0.60 ppm
----------------------------------------------------------------------------------------------------------------
Goat, meat                                                                                              0.07 ppm
----------------------------------------------------------------------------------------------------------------
Grain, aspirated grain fractions                                                                         103 ppm
----------------------------------------------------------------------------------------------------------------
Horse, fat                                                                                              0.60 ppm
----------------------------------------------------------------------------------------------------------------
Horse, meat byproducts                                                                                  0.60 ppm
----------------------------------------------------------------------------------------------------------------
Horse, meat                                                                                             0.07 ppm
----------------------------------------------------------------------------------------------------------------
Milk                                                                                                    0.15 ppm
----------------------------------------------------------------------------------------------------------------

[[Page 50921]]


Milk, fat                                                                                               0.80 ppm
----------------------------------------------------------------------------------------------------------------
Pea and bean, dried shelled, except soybean, subgroup                                                   0.60 ppm
 6C
----------------------------------------------------------------------------------------------------------------
Pea and bean, succulent shelled, subgroup 6B                                                            0.05 ppm
----------------------------------------------------------------------------------------------------------------
Poultry, fat                                                                                            0.15 ppm
----------------------------------------------------------------------------------------------------------------
Poultry, liver                                                                                          0.03 ppm
----------------------------------------------------------------------------------------------------------------
Poultry, meat                                                                                           0.01 ppm
----------------------------------------------------------------------------------------------------------------
Rice, grain\1\                                                                                          0.50 ppm
----------------------------------------------------------------------------------------------------------------
Sheep, fat                                                                                              0.60 ppm
----------------------------------------------------------------------------------------------------------------
Sheep, meat byproducts                                                                                  0.60 ppm
----------------------------------------------------------------------------------------------------------------
Sheep, meat                                                                                             0.07 ppm
----------------------------------------------------------------------------------------------------------------
Soybean, forage                                                                                           18 ppm
----------------------------------------------------------------------------------------------------------------
Soybean, hay                                                                                              60 ppm
----------------------------------------------------------------------------------------------------------------
Soybean, hulls                                                                                          0.80 ppm
----------------------------------------------------------------------------------------------------------------
Soybean, seed                                                                                           0.25 ppm
----------------------------------------------------------------------------------------------------------------
Vegetable, foliage of legume, except soybean, subgroup                                                    35 ppm
 7A
----------------------------------------------------------------------------------------------------------------
Vegetable, legume, edible podded, subgroup 6A                                                           0.50 ppm
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------

    \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 paragraphs (a)(1) and (a)(2) of this section:

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Alfalfa, forage                                                                                         0.15 ppm
----------------------------------------------------------------------------------------------------------------
Alfalfa, hay                                                                                            0.04 ppm
----------------------------------------------------------------------------------------------------------------
Barley, hay                                                                                             0.04 ppm
----------------------------------------------------------------------------------------------------------------
Barley, straw                                                                                           0.07 ppm
----------------------------------------------------------------------------------------------------------------
Buckwheat                                                                                               0.07 ppm
----------------------------------------------------------------------------------------------------------------
Clover, forage                                                                                          0.15 ppm
----------------------------------------------------------------------------------------------------------------
Clover, hay                                                                                             0.04 ppm
----------------------------------------------------------------------------------------------------------------
Grass, forage                                                                                           0.15 ppm
----------------------------------------------------------------------------------------------------------------
Grass, hay                                                                                              0.04 ppm
----------------------------------------------------------------------------------------------------------------
Millet, pearl, forage                                                                                   0.15 ppm
----------------------------------------------------------------------------------------------------------------
Millet, pearl, hay                                                                                      0.04 ppm
----------------------------------------------------------------------------------------------------------------
Millet, proso, forage                                                                                   0.15 ppm
----------------------------------------------------------------------------------------------------------------
Millet, proso, hay                                                                                      0.04 ppm
----------------------------------------------------------------------------------------------------------------
Millet, proso, straw                                                                                    0.07 ppm
----------------------------------------------------------------------------------------------------------------

[[Page 50922]]


Oats, forage                                                                                            0.15 ppm
----------------------------------------------------------------------------------------------------------------
Oats, hay                                                                                               0.04 ppm
----------------------------------------------------------------------------------------------------------------
Oats, straw                                                                                             0.07 ppm
----------------------------------------------------------------------------------------------------------------
Rye, forage                                                                                             0.15 ppm
----------------------------------------------------------------------------------------------------------------
Rye, straw                                                                                              0.07 ppm
----------------------------------------------------------------------------------------------------------------
Sorghum, grain, forage                                                                                  0.03 ppm
----------------------------------------------------------------------------------------------------------------
Sorghum, grain, stover                                                                                  0.06 ppm
----------------------------------------------------------------------------------------------------------------
Teosinte, forage                                                                                        0.15 ppm
----------------------------------------------------------------------------------------------------------------
Teosinte, hay                                                                                           0.04 ppm
----------------------------------------------------------------------------------------------------------------
Teosinte, straw                                                                                         0.07 ppm
----------------------------------------------------------------------------------------------------------------
Triticale, forage                                                                                       0.15 ppm
----------------------------------------------------------------------------------------------------------------
Triticale, hay                                                                                          0.04 ppm
----------------------------------------------------------------------------------------------------------------
Triticale, straw                                                                                        0.07 ppm
----------------------------------------------------------------------------------------------------------------
Wheat, forage                                                                                           0.15 ppm
----------------------------------------------------------------------------------------------------------------
Wheat, hay                                                                                              0.03 ppm
----------------------------------------------------------------------------------------------------------------
Wheat, straw                                                                                            0.03 ppm
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-20443 Filed 8-17-10; 8:45 am]
BILLING CODE 6560-50-S

