[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Rules and Regulations]
[Pages 44815-44821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18708]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0888; FRL-8875-5]


Chlorantraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
chlorantraniliprole in or on multiple commodities which are identified 
and discussed later in this document. This regulation additionally 
amends previously established tolerances in or on multiple commodities 
and deletes tolerances in or on several commodities that will be 
superceded by inclusion in crop group tolerances. E. I. du Pont de 
Nemours and Company, DuPont Crop Protection, requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 27, 2011. Objections and 
requests for hearings must be received on or before September 26, 2011, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0888. 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,

[[Page 44816]]

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: Rita Kumar, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8291; e-mail address: [email protected].

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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2010-0888 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
September 26, 2011. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0888, 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 Tolerance

    In the Federal Register of February 25, 2011 (76 FR 10584) (FRL-
8863-3), 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 
0F7763) by, E. I. du Pont de Nemours and Company, DuPont Crop 
Protection, 1700 Market St., Wilmington, DE 19898. The petition 
requested that 40 CFR 180.628 be amended by establishing tolerances for 
residues of the insecticide chlorantraniliprole, 3-bromo-N-[4-chloro-2-
methyl-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-
pyrazole-5-carboxamide, in or on bushberry, subgroup 13-07B at 2.5 
parts per million (ppm); large shrub/tree berry, subgroup 13-07C at 2.5 
ppm; low growing berry, subgroup 13-07G at 2.5 ppm; ti palm, roots at 
0.35 ppm; ti palm, leaves at 13 ppm; root and tuber vegetables, group 1 
at 0.35 ppm; leaves of root and tuber vegetables, group 2 at 40 ppm; 
sugar beet molasses at 11 ppm; onion, bulb, subgroup 3-07A at 0.35 ppm; 
peanut, nutmeat at 0.35 ppm; peanut, hay at 90 ppm; tea, dried leaves 
at 50 ppm; and to increase tolerances in or on fruiting vegetables 
(except cucurbits), group 8 from 0.7 ppm to 0.90 ppm; cucurbit 
vegetables, group 9 from 0.25 ppm to 0.30 ppm; and okra from 0.70 ppm 
to 0.90 ppm. That notice referenced a summary of the petition prepared 
by E. I. du Pont de Nemours and Company, DuPont Crop Protection, the 
registrant, which is available 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 the petition, EPA has 
revised the tolerances for some of the petitioned commodities. 
Additionally, the Agency is revising tolerances for several proposed 
individual and group commodities and is revoking multiple established 
tolerances. The reason for these changes are 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

[[Page 44817]]

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 chlorantraniliprole 
including exposure resulting from the tolerances established by this 
action. EPA's assessment of exposures and risks associated with 
chlorantraniliprole 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.
    Sufficient toxicology information exists for chlorantraniliprole 
for selecting doses and endpoints needed for assessing its risk to 
humans when used as an insecticide. Chlorantraniliprole is not 
genotoxic, neurotoxic, immunotoxic, carcinogenic, or developmentally 
toxic. Chlorantraniliprole is not acutely toxic via oral, dermal or 
inhalation routes of exposure. Neither is chlorantraniliprole an eye or 
skin irritant nor a dermal sensitizer. There was only one animal 
toxicity study (18-month carcinogenicity study in mice) in the 
toxicology database which evidenced any adverse effect of 
chlorantraniliprole exposure. This study was used to establish a point 
of departure (POD), based on hepatocellular effects, for the chronic 
dietary exposure scenario.
    Specific information on the studies received and the nature of the 
adverse effects caused by chlorantraniliprole 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 at http://www.regulations.gov in document ``Human Health Risk Assessment for 
Proposed Label Amendments to Remove Adjuvant Restrictions with 
Concomitant Increase in Tolerance for Fruiting and Leafy Vegetables and 
to Add Oilseed Rotational Crops,'' at page 22 in docket ID number EPA-
HQ-OPP-2010-0888.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern (LOC) to use in evaluating the risk posed by human exposure to 
the pesticide. For hazards that have a threshold below which there is 
no appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which 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 chlorantraniliprole 
used for human risk assessment is shown in the following Table.

    Table--Summary of Toxicological Doses and Endpoints for Chlorantraniliprole for Use in Human Health Risk
                                                   Assessment
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                                        Point of departure and
          Exposure/Scenario               uncertainty/Safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
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Acute dietary (All populations)......  Not Applicable (N/A)...  N/A....................  No acute hazard
                                                                                          attributable to a
                                                                                          single dose was
                                                                                          identified; therefore,
                                                                                          an acute dietary
                                                                                          endpoint was not
                                                                                          selected for
                                                                                          quantitative risk
                                                                                          assessment.
Chronic dietary (All populations)....  NOAEL = 158 milligrams/  Chronic RfD = 1.58 mg/   18-Month Oral (feeding)/
                                        kilogram/day (mg/kg/     kg/day                   mouse LOAEL = 935 mg/
                                        day).                   cPAD = 1.58 mg/kg/day..   kg/day based on
                                       UFA = 10x..............                            eosinophilic foci
                                       UFH = 10 x.............                            accompanied by
                                       FQPA SF = 1x...........                            hepatocellular
                                                                                          hypertrophy and
                                                                                          increased liver weight
                                                                                          (males only).
Incidental oral short/intermediate-    N/A....................  N/A....................  There was no hazard
 term (1 to 30 days).                                                                     identified via the
                                                                                          oral route over the
                                                                                          short- and
                                                                                          intermediate-term and
                                                                                          therefore, no endpoint
                                                                                          was selected for
                                                                                          quantitative risk
                                                                                          assessment.
Dermal short/intermediate-term.......  N/A....................  N/A....................  There was no hazard
                                                                                          identified via the
                                                                                          dermal route (and no
                                                                                          concerns for
                                                                                          developmental,
                                                                                          reproductive or
                                                                                          neurotoxic effects)
                                                                                          and therefore, no
                                                                                          dermal endpoint was
                                                                                          selected for
                                                                                          quantitative risk
                                                                                          assessment.

[[Page 44818]]

 
Inhalation short/intermediate-term...  N/A....................  N/A....................  Based on the lack of
                                                                                          hazard identified in
                                                                                          the acute inhalation
                                                                                          study, lack of acute
                                                                                          irritation, and
                                                                                          extremely low oral
                                                                                          toxicity--no
                                                                                          inhalation endpoint
                                                                                          was selected for
                                                                                          quantitative risk
                                                                                          assessment.
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Cancer (Oral, dermal, inhalation)....  Classification: ``Not likely to be Carcinogenic to Humans'' based on
                                        weight of evidence of data: no treatment-related tumors reported in the
                                        submitted chronic and oncogenicity studies in rats and mice, subchronic
                                        studies in mice, dogs and rats and that no mutagenic concern was
                                        reported in the genotoxicity studies.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population-adjusted dose (a= acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of corcern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to chlorantraniliprole, EPA considered exposure under the 
petitioned-for tolerances as well as all existing chlorantraniliprole 
tolerances in 40 CFR 180.628. EPA assessed dietary exposures from 
chlorantraniliprole 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.
    No such effects were identified in the toxicological studies for 
chlorantraniliprole; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 Continuing Survey of Food Intake by Individual (CSFII). As to 
residue levels in food, EPA assumed recommended and/or established 
tolerance level residues and 100 percent crop treated (PCT). DEEM 
default processing factors were used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that chlorantraniliprole does not pose a cancer risk to 
humans. Therefore, a dietary exposure assessment for the purpose of 
assessing cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for chlorantraniliprole. Tolerance level residues and/or 100 PCT were 
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for chlorantraniliprole in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of chlorantraniliprole. 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 First Index Reservoir Screening Tool (FIRST), 
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, 
the acute and chronic estimated drinking water concentrations (EDWCs) 
of chlorantraniliprole were 55.30 parts per billion (ppb) and 39.87 
ppb, respectively.
    The surface water concentration of 39.87 ppb was used for chronic 
exposure for the chronic, non-cancer dietary risk assessment.
    No acute dietary risk assessment was performed because no acute 
hazard was identified.
    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).
    Chlorantraniliprole is currently registered for the following uses 
that could result in residential exposures: Turfgrass and ornamental 
plants. Residential exposure could occur for short-term and 
intermediate-term exposures however, due to the lack of toxicity 
identified for short- and intermediate-term durations via relevant 
routes of exposure, no risk is expected from these exposures. 
Additional information on residential exposure assumptions can be found 
at http//www.regulations.gov (Docket ID EPA-HQ-OPP-2010--0888, ``Human 
Health Risk Assessment for Proposed Label Amendments to Remove Adjuvant 
Restrictions with Concomitant Increase in Tolerance for Fruiting and 
Leafy Vegetables and to Add Oilseed Rotational crops '', page 37).
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 chlorantraniliprole to share a common mechanism 
of toxicity with any other substances, and chlorantraniliprole does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
chlorantraniliprole 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

[[Page 44819]]

chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA SF. In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There were no effects on 
fetal growth or postnatal development up to the limit dose of 1,000 mg/
kg/day in rats or rabbits in the developmental or 2-generation 
reproduction studies. Additionally, there were no treatment related 
effects on the numbers of litters, fetuses (live or dead), resorptions, 
sex ratio, or post-implantation loss and no effects on fetal body 
weights, skeletal ossification, and external, visceral, or skeletal 
malformations or variations.
    3. Conclusion. EPA has determined that reliable data show 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 toxicity database for chlorantraniliprole is complete, and 
considered adequate for this risk assessment (including 40 CFR 158.500 
requirements for dermal toxicity, immunotoxicity, and acute/subchronic 
neurotoxicity effective December 26, 2007).
    ii. There is no indication that chlorantraniliprole is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that chlorantraniliprole results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to chlorantraniliprole in drinking water. Due 
to the lack of toxicity via the dermal route, as well as the lack of 
toxicity over the acute-, short- and intermediate-term via the oral 
route--no risk is expected from postapplication exposure of children as 
well as incidental oral exposure of toddlers. These assessments will 
not underestimate the exposure and risks posed by chlorantraniliprole.

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.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
chlorantraniliprole is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
chlorantraniliprole from food and water will utilize 6% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
chlorantraniliprole is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Although short-term residential exposure could occur with the use 
of chlorantraniliprole, no toxicological effects resulting from short-
term dosing were observed. Therefore, the aggregate risk is the sum of 
the risk from food and water and will not be greater than the chronic 
aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Although intermediate-term residential exposure could result from 
the use of chlorantraniliprole, no toxicological effects resulting from 
intermediate-term dosing were observed. Therefore, the aggregate risk 
is the sum of the risk from food and water and will not be greater than 
the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two rodent carcinogenicity studies, 
chlorantraniliprole is not expected to pose a cancer risk to humans.
    6. 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 chlorantraniliprole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography mass 
spectrometry (LC/MS/MS)) is available to enforce the tolerance 
expression. The method may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint 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, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex and Canada have established maximum residue levels (MRLs) 
for chlorantraniliprole in or on a number of crops and animal 
commodities. These MRLs are different than the tolerances established 
for chlorantraniliprole in the United States. There are no Mexican MRLs 
for chlorantraniliprole as Mexico adopts

[[Page 44820]]

Codex or US standards for its export purposes. Refer to the 
International Residue Limit Status appended at the end of the document 
``Human Health Risk Assessment for Proposed Label Amendments to Remove 
Adjuvant Restrictions with Concomitant Increase in Tolerance for 
Fruiting and Leafy Vegetables and to Add Oilseed Rotational Crops,'' 
pages 52-53, and an addendum to this risk assessment, at http://www.regulations.gov (Docket ID EPA-HQ-OPP-2010-0888).
    Although the tolerance expression achieved harmonization, 
harmonized MRLs were only achieved for a few commodities. This is the 
result of differences in crop grouping and removing the adjuvant 
restriction in the United States. To allow for the use of adjuvant in 
the United States it was necessary to adjust the tolerances by a factor 
of two for some crop groups after reviewing bridging residue data. This 
causes disharmony with Codex MRLs for berries, curcubits, fruiting 
vegetable, root and tuber vegetables, and leaves of root and tuber 
vegetables; and with Canada MRLs for curcubit vegetables and fruiting 
vegetables.

C. Response to Comments

    There were no comments received in response to the notice of 
filing.

D. Revisions to Petitioned-For Tolerances

    Based on residue data submitted with this petition, several 
petitioned-for tolerances were revised. The revisions include: 
increases for fruiting vegetables except cucurbits from 0.9 to 1.4 ppm, 
and cucurbits from 0.3 to 0.5 ppm; decreases in low growing berries 
from 2.5 to 1.0 ppm, onions, bulb from 0.35 to 0.30 ppm, beet, sugar, 
molasses from 11 to 9 ppm, Ti, root from 0.35 to 0.30 ppm, and root and 
tuber vegetables from 0.35 to 0.30 ppm.
    Tolerances for okra, strawberry, and vegetables, tuberous and corm, 
subgroup 1C were deleted as these commodities are now covered by 
fruiting vegetables crop group 8-10, berry, low-growing subgroup 13-
07G, and vegetable, root and tuber, group 1, respectively.
    The proposed tolerances for peanut hay and peanut nutmeat are not 
being established at this time. More residue data are needed.
    In Sec.  180.628(d), the tolerance for vegetables, leaves of root 
and tuber, group 2 was replaced by the tolerance for this crop group in 
Sec.  180.628(a). The tolerance for shallot, fresh leaves was added to 
Sec.  180.628(d).

V. Conclusion

    Therefore, tolerances are established for residues of 
chlorantraniliprole, including its metabolites and degradates, in or on 
the commodities listed in Sec.  180.368. Compliance with the tolerance 
levels specified below is to be determined by measuring only 
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide. 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide. Tolerances are established in or on the following 
commodities: Bushberry, subgroup 13-07B at 2.5 ppm; Vegetable, 
cucurbit, group 9 at 0.5 ppm; vegetable fruiting, group 8-10 at 1.4 
ppm; Berry, large shrub/tree, subgroup 13-07C at 2.5 ppm; Vegetable, 
leaves of root and tuber, group 2 at 40 ppm; Berry, low growing 
subgroup 13-07G at 1.0 ppm; Onion, bulb, subgroup 3-07A at 0.30 ppm; 
Vegetable, root and tuber, group 1 at 0.30 ppm; Beet, sugar, molasses 
at 9 ppm; Tea, dried at 50 ppm; Ti, leaves, at 13 ppm; and Ti, root, at 
0.30 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal governments, on the relationship between the national government 
and the States or Tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

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


[[Page 44821]]


    Dated: July 12, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Section 180. 628 is amended as follows:
0
i. Add alphabetically tolerances for beet, sugar, molasses; berry large 
shrub/tree, subgroup 13-07C; berry, low growing, subgroup at 13-07G; 
onion, bulb, subgroup 3-07A; tea, dried; Ti, leaves; Ti, root; 
vegetable, leaves of root and tuber, group 2; vegetable, root and 
tuber, group 1; to the table in paragraph (a);
0
ii. Revise the tolerances for vegetable, cucurbit, group 9; and 
vegetable, fruiting, group 8-10 in the table to paragraph (a);
0
iii. Remove the entries for okra, strawberry, and vegetable, tuberous 
and corm, subgroup 1C from the table in paragraph (a);
0
iv. Remove the entries for shallot and vegetables, leaves of root and 
tuber, group 2 from paragraph (d); and
0
v. Add alphabetically an entry for shallot, green leaves to the table 
in paragraph (d).
    The added and revised text read as follows:


Sec.  180.628  Chlorantraniliprole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Beet, sugar, molasses........................................       9.0
Berry, large shrub/tree, subgroup 13-07C.....................       2.5
Berry, low growing, subgroup 13-07G..........................       1.0
 
                                * * * * *
Onion, bulb, subgroup 3-07A..................................       0.30
 
                                * * * * *
Tea, dried...................................................      50.0
 
                                * * * * *
Ti, leaves...................................................      13.0
Ti, root.....................................................       0.3
 
                                * * * * *
Vegetable, cucurbit, group 9.................................       0.5
 
                                * * * * *
Vegetable, fruiting, group 8-10..............................       1.4
 
                                * * * * *
Vegetable, leaves of root and tuber, group 2.................      40.0
 
                                * * * * *
Vegetable, root and tuber, group 1...........................       0.30
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (d) * * *

------------------------------------------------------------------------
                                                             Expiration/
                  Commodity                     Parts per    revocation
                                                 million        date
------------------------------------------------------------------------
 
                                * * * * *
Shallots, fresh leaves......................          0.20      04/10/14
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2011-18708 Filed 7-26-11; 8:45 am]
BILLING CODE 6560-50-P