
[Federal Register: August 13, 2008 (Volume 73, Number 157)]
[Rules and Regulations]               
[Page 47057-47063]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au08-10]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0099; FRL-8360-2]

 
Flubendiamide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
insecticide flubendiamide per se, N2-[1,1-Dimethyl-2-
(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-[1,2,2,2-
tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide, 
in or on certain food and raw agricultural commodities. 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 13, 2008. Objections and 
requests for hearings must be received on or before October 14, 2008, 
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. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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 
Room S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA 22202-4501. 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 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0327; 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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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 requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before October 14, 2008.
    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

[[Page 47058]]

public docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, 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 
Avenue, NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Room S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA 22202-4501. Deliveries 
are only accepted during the Docket'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. Petition for Tolerance

    In the Federal Register of February 28, 2007 (72 FR 9000) (FRL-
8115-2), 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 
6F7065) 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 part 
180 be amended by establishing permanent tolerances in primary crops 
for residues of the insecticide flubendiamide, N2-[1,1-
Dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-
[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-
benzenedicarboxamide, in or on the following raw agricultural and 
processed commodities: Almond, hulls at 9.0 parts per million (ppm); 
brassica, head and stem subgroup at 0.60 ppm; brassica, leafy greens 
subgroup at 6.0 ppm; corn, field, forage at 8.0 ppm; corn, corn, field, 
grain at 0.02 ppm; field, stover at 15.0 ppm; corn, pop, grain at 0.02 
ppm; corn, pop, stover at 15.0 ppm; corn, sweet, forage at 9.0 ppm; 
corn, sweet, kernel plus cob with husks removed at 0.02 ppm; corn, 
sweet, stover at 25.0 ppm; cottonseed at 2.0 ppm; cotton, gin byproduct 
at 60.0 ppm; fruit, pome group at 0.7 ppm; fruit, stone group at 1.6 
ppm; grape at 1.4 ppm; nut, tree group at 0.06 ppm; okra at 0.30 ppm; 
vegetable, cucurbit group at 0.20 ppm; vegetable, fruiting group at 
0.30 ppm and vegetable, leafy, except brassica at 11.0 ppm; in or on 
the following rotational crop commodities: Alfalfa, forage at 0.15 ppm; 
alfalfa, hay at 0.04 ppm; barley, hay at 0.04 ppm; barley, straw at 
0.07 ppm; buckwheat at 0.07 ppm; clover, forage at 0.15 ppm; clover, 
hay at 0.04 ppm; grass, forage at 0.15 ppm; grass, hay at 0.04 ppm; 
grass, silage at 0.27 ppm; millet, pearl, forage at 0.15 ppm; millet, 
pearl hay at 0.04 ppm; millet, proso, forage at 0.15 ppm; millet, 
proso, hay at 0.04 ppm; millet, proso, straw at 0.07 ppm; oats, forage 
at 0.15 ppm; oats, hay at 0.04 ppm; oats, straw at 0.07 ppm; rye, 
forage at 0.15 ppm; rye, straw at 0.07 ppm; sorghum, grain, forage at 
0.03 ppm; sorghum, grain, stover at 0.06 ppm; soybean, forage at 0.02 
ppm; soybean, hay at 0.04 ppm; teosinte, forage at 0.15 ppm; teosinte, 
hay at 0.04 ppm; teosinte, straw at 0.07 ppm; triticale, forage at 0.15 
ppm; triticale, hay at 0.04 ppm; triticale, straw at 0.07 ppm; wheat, 
forage at 0.15 ppm; wheat, hay at 0.03 ppm and wheat, straw at 0.03 
ppm; and in the following livestock commodities: Cattle, fat at 0.80 
ppm; cattle, kidney at 0.60 ppm; cattle, liver at 0.60 ppm; cattle, 
muscle at 0.10 ppm; eggs at 0.03 ppm; goat, fat at 0.80 ppm; goat, 
kidney at 0.60 ppm; goat, liver at 0.60 ppm; goat, muscle at 0.10 ppm; 
hog, fat at 0.80 ppm; hog, kidney at 0.60 ppm; hog, liver at 0.60 ppm; 
hog, muscle at 0.10 ppm; horse, fat at 0.80 ppm; horse, kidney at 0.60 
ppm; horse, liver at 0.60 ppm; horse, muscle at 0.10 ppm; milk at 0.20 
ppm; poultry, fat at 0.08 ppm; poultry, liver at 0.03 ppm; poultry, 
muscle at 0.01 ppm; sheep, fat at 0.80 ppm; sheep, kidney at 0.60 ppm; 
sheep, liver at 0.60 ppm; and sheep, muscle at 0.10 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 to the public in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Based upon review of the data supporting this petition and EPA 
policy, the Agency has revised commodity definitions and/or some of the 
proposed tolerances and concludes that the establishment of the 
following tolerance is appropriate for the insecticide flubendiamide 
per se in or on the following food commodities: Almond, hulls at 9.0 
ppm; apple, wet pomace at 2.0 ppm; brassica, head and stem, subgroup 5A 
at 0.60 ppm; brassica, leafy greens, subgroup 5B at 5.0 ppm; cattle, 
fat at 0.30 ppm; cattle, kidney at 0.30 ppm; cattle, liver at 0.30 ppm; 
cattle, muscle at 0.05 ppm; corn, field, forage at 8.0 ppm; corn, 
field, grain at 0.02 ppm; corn, field, stover at 15 ppm; corn, pop, 
grain at 0.02 ppm; corn, pop, stover at 15 ppm; corn, sweet, forage at 
9.0 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; 
corn, sweet, stover at 25 ppm; cotton gin byproducts at 60 ppm; cotton, 
undelinted seed at 0.90 ppm; egg at 0.01 ppm; fruit, pome, group 11 at 
0.70 ppm; fruit, stone, group 12 at 1.6 ppm; goat, fat at 0.30 ppm; 
goat, kidney at 0.30 ppm; goat, liver at 0.30 ppm; goat, muscle at 0.05 
ppm; grain, aspirated fractions at 5.0 ppm; grape at 1.4 ppm; horse, 
fat at 0.30 ppm; horse, kidney at 0.30 ppm; horse, liver at 0.30 ppm; 
horse, muscle at 0.05 ppm; milk at 0.04 ppm; milk, fat at 0.30 ppm; 
nut, tree, group 14 at 0.06 ppm; okra at 0.30 ppm; poultry, fat at 0.02 
ppm; poultry, liver at 0.01 ppm; poultry, muscle at 0.01 ppm; sheep, 
fat at 0.30 ppm; sheep, kidney at 0.30 ppm; sheep, liver at 0.30 ppm; 
sheep, muscle at 0.05 ppm; vegetable, cucurbit, group 9 at 0.20 ppm; 
vegetable, fruiting, group 8 at 0.60 ppm and vegetable, leafy, except 
brassica, group 4 at 11 ppm; and in or on the following raw 
agricultural commodities: Alfalfa, forage at 0.15 ppm; alfalfa, hay at 
0.04 ppm; barley, hay at 0.04 ppm; barley, straw at 0.07 ppm; buckwheat 
at 0.07 ppm; clover, forage at 0.15 ppm; clover, hay at 0.04 ppm; 
grass, forage at 0.15 ppm; grass, hay at 0.04 ppm; millet, pearl, 
forage at 0.15 ppm; millet, pearl, hay at 0.04 ppm; millet, proso, 
forage at 0.15 ppm; millet, proso, hay at 0.04 ppm; millet, proso, 
straw at 0.07 ppm; oats, forage at 0.15 ppm; oats, hay at 0.04 ppm; 
oats, straw at 0.07 ppm; rye, forage at 0.15 ppm; rye, straw at 0.07 
ppm; sorghum, grain, forage at 0.03 ppm; sorghum, grain, stover at 0.06 
ppm; soybean, forage at 0.02 ppm; soybean, hay at 0.04 ppm; teosinte, 
forage at 0.15 ppm; teosinte, hay at 0.04 ppm; teosinte, straw at 0.07 
ppm; triticale, forage at 0.15 ppm; triticale, hay at 0.04 ppm; 
triticale, straw at 0.07 ppm; wheat, forage at 0.15 ppm; wheat, hay at 
0.03 ppm and wheat, straw at 0.03 ppm.

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

[[Page 47059]]

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 submitted 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 the insecticide 
flubendiamide. EPA's assessment of exposures and risks associated with 
establishing tolerances 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 low acute toxicity via the oral and dermal 
routes, is only a slight eye irritant, is non-irritating to the dermis 
and tests negative for skin sensitization. In the longer-term studies 
in the flubendiamide mammalian toxicology database, the primary target 
organs identified were the liver, thyroid, kidney and eyes. Liver 
effects reported in rats, mice and/or dogs include organ weight 
increase, periportal fatty change, hypertrophy and minimal foci of 
cellular alteration. Thyroid effects include organ weight increase, 
follicular cell hypertrophy and slight perturbations of 
triiodothyronine (TC) and thyroid stimulating hormone (TSH) in the rat 
and mouse. Kidney effects include increases in absolute and/or relative 
to body kidney weights and chronic nephropathy in the rat. Eye effects 
include eye enlargement, opacity and exophthalmus with hemorrhage and 
appear only in rat pups. Other changes include mild microcytic anemia, 
decreased serum triglycerides and cholesterol in female rat, increased 
gamma glutamyl peptidase, alkaline phosphatase and shortened activated 
prothrombin time in dogs, and adrenal weight increase and an increase 
in adrenal cortical cell hypertrophy in dogs.
    The hazard assessment indicated potential toxicity resulting from 
exposure to flubendiamide via different routes over different 
durations. The observed eye effects were selected as a critical effect 
for the acute dietary exposure scenario; whereas liver and thyroid 
effects were determined critical for the chronic dietary exposure 
scenario. Short-term and intermediate-term dermal risks were also based 
on liver and thyroid effects as well as blood effects. Short-term and 
intermediate-term inhalation risks are based on liver toxicity as well 
as adrenal weight increase and an increase in adrenal cortical cell 
hypertrophy.
    There was no evidence of carcinogenicity in rats and mice up to the 
limit dose at 24- and 18-months, respectively. Flubendiamide was 
determined to be non-mutagenic in bacteria, negative in an in vivo 
mammalian cytogenetics assay and did not cause unscheduled DNA 
synthesis (repair of DNA damage) in mammalian cells in vitro. Overall, 
there was no clear evidence that flubendiamide was either mutagenic or 
clastogenic in either in vivo or in vitro assays. The cancer 
classification is ``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 no-observed-
adverse-effect-level (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, and is 
identified as EPA-HQ-OPP-2007-0099-0005 in that docket. 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 Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term and chronic-term risks are evaluated by comparing 
food, water and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    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 
greater than that 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, refer to 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, and is identified as EPA-
HQ-OPP-2007-0099-0005 in that docket. 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

[[Page 47060]]

petitioned-for tolerances and assessed dietary exposures from 
flubendiamide in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. In estimating acute dietary 
exposure, EPA used food consumption information from the Dietary 
Exposure Evaluation Model-Food Commodity Intake Database (DEEM-
FCID\TM\, Version 2.03), which incorporates food consumption data from 
the U.S. Department of Agriculture's (USDA's) Nationwide Continuing 
Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. 
The acute assessments assumed that 100% of crops with requested uses of 
flubendiamide are treated and that all treated crops contain residues 
at tolerance-level. In addition, tolerance-level residues for livestock 
commodities were included in these analyses to account for the 
potential transfer of plant residues to livestock tissues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used DEEM-FCID\TM\, Version 2.03, which incorporates 
food consumption data from the USDA's CSFII from 1994-1996 and 1998. 
The chronic assessments assumed that 100% of crops with requested uses 
of flubendiamide are treated and that all treated crops contain 
residues at the average residue levels found in the crop field trials 
and experimentally-determined processing factors where available. In 
addition, average-level residues for livestock commodities were also 
included in these analyses to account for the potential transfer of 
plant residues to livestock tissues.
    iii. Cancer. As explained in Unit III.A., 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 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 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.
    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 lacks 
sufficient monitoring exposure data for use in risk assessments, as 
flubendiamide is a new active ingredient. Because the Agency does not 
have comprehensive monitoring data, drinking water concentration 
estimates are made by reliance on simulation or modeling, taking into 
account data on the physical and fate 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.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and the Screening Concentration in Ground Water 
(SCI-GROW) model, the estimated drinking water concerns (EDWCs) of 
flubendiamide for acute exposures are estimated to be 12.93 parts per 
billion (ppb) for surface water and 0.06 ppb for ground water. For 
chronic exposures for non-cancer assessments, the EDWCs are estimated 
to be 11.95 ppb for surface water and 0.06 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 12.93 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 11.95 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (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 ten-fold (10x) margin of safety for infants 
and children in the case of threshold effects to account for pre-natal 
and/or post-natal toxicity, and the completeness of the database on 
toxicity and exposure, unless EPA determines based on reliable data 
that a different margin of safety will be safe for infants and 
children. This additional margin of safety is commonly referred to as 
the Food Quality Protection Act Safety Factor (FQPA SF). In applying 
this provision, EPA either retains the default value of 10x or uses a 
different additional SF when reliable data available to EPA support the 
choice of a different factor.
    2. 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) and 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

[[Page 47061]]

effects did not occur in adult rats. Since the iris and chamber angle 
are differentiating and specializing into definite structures during 
post-natal days 5-20, 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 balano-preputial separation 
(separation of the prepuce (foreskin) from the glans penis (balanus)) 
delay. While these effects are considered adverse, they are not assumed 
to be developmental effects from in utero exposure. Even though the 
delay in balanopreputial separation may be a result of post-natal 
exposure (sensitivity of the young), and the effect is adverse, it is 
considered reversible and not an indication of perinatal sensitivity/
susceptibility.
    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 as 
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 for 
purposes of this risk assessment and the characterization of potential 
pre-natal and/or post-natal risks to infants and children. 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.
    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 the previous paragraph, the PODs 
employed in the risk assessment are protective of this effect.
    iii. There are no residual uncertainties identified in the exposure 
databases and the exposure assessment is protective. The acute dietary 
food exposure assessment utilizes tolerance-level residues, the chronic 
dietary food exposure assessment utilizes 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 pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    For flubendiamide, there is potential exposure from food and 
drinking water, but not from residential use sites (as there are no 
proposed 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 8% 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 less than 15% of the 
cPAD for the mostly highly exposed population subgroup, children aged 
1-2 years old. There are no residential uses for flubendiamide.
    3. Aggregate cancer risk for U.S. population. 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

    There are currently no established CODEX, Canadian or Mexican 
maximum residue limits (MRLs) for residues of flubendiamide in or on 
various crop or livestock commodities.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data submitted in support of this 
tolerance petition for flubendiamide and EPA policy, the Agency has 
revised commodity definitions and/or some of the proposed tolerances. 
No residue data were submitted to support the proposed uses on okra and 
popcorn. The available field trial data for fruiting vegetables may be 
translated to okra, and the submitted data for field corn may also be 
translated to popcorn. The proposed uses on all types of corn (field, 
pop and sweet) are identical.
    Parent residue levels vary based on crop (for edible commodities, 
residues ranging from 0.018 ppm, corn, field, grain to 6.7 ppm, 
spinach). Most crops indicated parent residues declined with successive 
sampling dates and were determined to be available on the surface of 
plants/RACs. The Agency will allow translation of residue data from 
trials conducted on rotated barley, sorghum and wheat to support the 
proposed rotational crop tolerances for the forages, hay and straw of 
other types of cereal grains and grasses. The Agency

[[Page 47062]]

will also allow translation of residue data from trials conducted on 
rotated soybean to support the proposed rotational crop tolerances for 
the forages, fodder, hay and straw on alfalfa and clover to support the 
rotational plant-back intervals. Based on the transfer coefficients for 
livestock tissues and the relatively low dietary burden for swine of 
0.02 ppm for flubendiamide, tolerances for hogs are not needed.

V. Conclusion

    Therefore, tolerances are established forresidues of the 
insecticide flubendiamide per se, N2-[1,1-Dimethyl-2-
(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-[1,2,2,2-
tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide.

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 rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, 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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This 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 rule. In addition, this 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 1, 2008.
Debra Edwards,
Director, 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 added to read as follows:


Sec.  180.639  Flubendiamide; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide flubendiamide per se, N2-[1,1-Dimethyl-2-
(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-[1,2,2,2-
tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide, 
in or on the following food commodities:

------------------------------------------------------------------------
                      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
Cattle, fat..........................................           0.30 ppm
Cattle, kidney.......................................           0.30 ppm
Cattle, liver........................................           0.30 ppm
Cattle, muscle.......................................           0.05 ppm
Corn, field, forage..................................            8.0 ppm
Corn, field, grain...................................           0.02 ppm
Corn, field, stover..................................             15 ppm
Corn, pop, grain.....................................           0.02 ppm
Corn, pop, stover....................................             15 ppm
Corn, sweet, forage..................................            9.0 ppm
Corn, sweet, kernel plus cob with husks removed......           0.01 ppm
Corn, sweet, stover..................................             25 ppm
Cotton, gin byproducts...............................             60 ppm
Cotton, undelinted seed..............................           0.90 ppm
Egg..................................................           0.01 ppm
Fruit, pome, group 11................................           0.70 ppm
Fruit, stone, group 12...............................            1.6 ppm
Goat, fat............................................           0.30 ppm
Goat, kidney.........................................           0.30 ppm
Goat, liver..........................................           0.30 ppm
Goat, muscle.........................................           0.05 ppm
Grain, aspirated fractions...........................            5.0 ppm
Grape................................................            1.4 ppm
Horse, fat...........................................           0.30 ppm
Horse, kidney........................................           0.30 ppm
Horse, liver.........................................           0.30 ppm
Horse, muscle........................................           0.05 ppm
Milk.................................................           0.04 ppm
Milk, fat............................................           0.30 ppm
Nut, tree, group 14..................................           0.06 ppm
Okra.................................................           0.30 ppm
Poultry, fat.........................................           0.02 ppm
Poultry, liver.......................................           0.01 ppm
Poultry, muscle......................................           0.01 ppm
Sheep, fat...........................................           0.30 ppm
Sheep, kidney........................................           0.30 ppm
Sheep, liver.........................................           0.30 ppm
Sheep, muscle........................................           0.05 ppm
Vegetable, cucurbit, group 9.........................           0.20 ppm
Vegetable, fruiting, group 8.........................           0.60 ppm
Vegetable, leafy, except Brassica, group 4...........             11 ppm
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established 
for the indirect or inadvertent residues of the

[[Page 47063]]

insecticide flubendiamide per se, N2-[1,1-Dimethyl-2-
(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-[1,2,2,2-
tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide, 
in or on the following raw agricultural commodities when present 
therein as a result of the application of flubendiamide per se to the 
growing crops listed in paragraph (a) 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
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
Soybean, forage......................................           0.02 ppm
Soybean, hay.........................................           0.04 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. E8-18324 Filed 8-12-08; 8:45 am]

BILLING CODE 6560-50-S
