Document ID: EPA-HQ-OPP-2008-0770-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Chlorantraniliprole
Posted Date: 2009-06-26T04:00Z

[Federal Register Volume 74, Number 122 (Friday, June 26, 2009)]
[Rules and Regulations]
[Pages 30470-30475]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14996]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0770; FRL-8413-6]

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 almonds; nut, tree, crop group 14, and 
pistachios. E.I. Du Pont de Nemours and Company requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This 
regulation also establishes time-limited rotational crop tolerances for 
residues of chlorantraniliprole in or on cowpeas, forage and hay; field 
peas, vines and hay; forage, fodder and straw of cereal grains, crop 
group 16; grass forage, fodder and hay, crop group 17; leaves of root 
and tuber vegetables, crop group 2, leeks, nongrass animal feeds 
(forage, fodder, straw and hay), crop group 18; okra; onions, green; 
onions, Welsh; peanuts, hay; shallots; soybeans, forage and hay; 
strawberries and sugarcane, sugar. The time-limited tolerances expire 
on April 25, 2010.

DATES: This regulation is effective June 26, 2009. Objections and 
requests for hearings must be received on or before August 25, 2009, 
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-2008-0770. 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: Kable Bo Davis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0415; e-mail address: davis.kable@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 electronically available documents 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 e-CFR cite 
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation

[[Page 30471]]

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-2008-0770 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 August 25, 2009.
    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 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-2008-0770, 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. Petition for Tolerance and Notice of Proposed Rulemaking

    In the Federal Register of December 3, 2008 (73 FR 73640) (FRL-
8390-4), 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 
8F7409) by E.I. du Pont de Nemours and Company, DuPont Crop Protection, 
1090 Elkton Road, Newark, DE 19711. 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)-1 H-pyrazole-
5-carboxamide, in or on almond hulls at 5.0 parts per million (ppm), 
nut, tree, crop group 14 at 0.07 ppm and pistachios at 0.07 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 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 the petition, EPA has 
reduced the recommended tolerance of 0.07 ppm for nut, tree, group 14 
and pistachios to 0.04 ppm. The reason for these changes are explained 
in Unit IV.D.
    In the Federal Register of October 1, 2008 (73 FR 57040-57046) 
(FRL-8382-4), EPA issued a proposed rule pursuant to sections 408(e) of 
the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d)(3). 
The rule proposed that 40 CFR 180.628 be amended by establishing time-
limited tolerances for indirect or inadvertent residues of 
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-[(methylamino) 
carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1 H-pyrazole-5-carboxamide, 
in or on cowpeas, forage and hay at 0.20 parts per million (ppm); field 
peas, vines and hay at 0.20 ppm; forage, fodder and straw of cereal 
grains, crop group 16 at 0.20 ppm, grass forage, fodder and hay, crop 
group 17 at 0.20 ppm; leaves of root and tuber vegetables, crop group 2 
at 0.20 ppm; leeks at 0.20 ppm; nongrass animal feeds (forage, fodder, 
straw and hay), crop group 18 at 0.20 ppm; okra at 0.70 ppm; onions, 
green at 0.20 ppm; onions, Welsh at 0.20 ppm; peanuts, hay at 0.20 ppm; 
shallots at 0.20 ppm; soybeans, forage and hay at 0.20 ppm; 
strawberries at 1.2 ppm; and sugarcane, sugar at 0.20 ppm. The proposal 
established a 60-day public comment period. There were no comments 
received in response to the proposed rule.
    This final rule completes Agency action on both the petition from 
E.I. Du Pont de Nemours and Company, DuPont Crop Protection, and EPA's 
proposed rulemaking of October 1, 2008.

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 chlorantraniliprole on almond, hulls at 5.0 
ppm, nut, tree, group 14 at 0.04 ppm and pistachio at 0.04 ppm. 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.
    Chlorantraniliprole is not genotoxic, neurotoxic, immunotoxic, 
carcinogenic, or teratogenic. Chlorantraniliprole has been found to 
have low acute toxicity by the oral, dermal, and inhalation routes of 
exposure and has little to no irritation effect on the eyes or skin. 
Additionally, chlorantraniliprole is not a dermal sensitizer. There was 
only one toxicity study in the toxicity database that indicated that 
chlorantraniliprole yielded an adverse effect (18-month oral/mouse). 
This study was used to establish a point of departure based on 
hepatocellular effects for chronic risk.
    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 Chlorantraniliprole (DPX-E2Y45). Human 
Health Risk Assessment for Proposed Uses on the Tree Nut Group and 
Pistachios and for Increases in the Established Tolerances for Pome 
Fruits, Stone Fruits, Grapes and Raisins due to the Removal of Adjuvant 
Restrictions from the Label for Pome Fruits, Stone

[[Page 30472]]

Fruits, and Grapes, page 21 in docket ID number EPA-HQ-OPP-2008-0770.

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 NOAEL in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, 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, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for chlorantraniliprole 
used for human risk assessment can be found at http://
www.regulations.gov in document Chlorantraniliprole (DPX-E2Y45). Human 
Health Risk Assessment for Proposed Uses on the Tree Nut Group and 
Pistachios and for Increases in the Established Tolerances for Pome 
Fruits, Stone Fruits, Grapes and Raisins due to the Removal of Adjuvant 
Restrictions from the Label for Pome Fruits, Stone Fruits, and Grapes, 
page 10 in docket ID number EPA-HQ-OPP-2008-0770.

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 United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey 
of Food Intake by Individuals (CSFII). As to residue levels in food, 
EPA assumed all foods for which there are tolerances were treated and 
contain tolerance-level residues.
    iii. Cancer. Chlorantraniliprole was classified as ``Not likely to 
be Carcinogenic to Humans'' based on evidence showing no treatment-
related tumors in the submitted chronic and oncogenicity studies in 
rats and mice, and subchronic studies in mice, dogs, and rats, and no 
mutagenic concerns in the genotoxicity studies. Therefore, an exposure 
assessment to evaluate cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
chlorantraniliprole for acute exposures are estimated to be 26.862 
parts per billion (ppb) for surface water and 1.06 ppb for ground 
water. The estimated drinking water concentrations (EDWCs) of 
chlorantraniliprole for chronic exposures are 3.650 parts per billion 
(ppb) for surface water and 1.06 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For chronic dietary risk assessment, the water concentration of 
value 3.650 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).
    Chlorantraniliprole is currently registered for the following uses 
that could result in residential exposures: Turfgrass and ornamental 
plants. EPA assessed residential exposure using the following 
assumptions. Although residential exposure could occur, 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 www.regulations.gov (Docket ID EPA-HQ-OPP-2007-0275, pages 36 
through 37).
    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 chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

[[Page 30473]]

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There were no effects on 
fetal growth or post-natal development up to the limit dose of 1,000 
milligrams/kilogram/day (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.
    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. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to 
chlorantraniliprole in drinking water. EPA used similarly conservative 
assumptions to assess post-application 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 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.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute 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 <1% of the cPAD 
for (children 1-2 years) 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. Chlorantraniliprole 
has been classified as a ``not likely human carcinogen.'' It 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 chromotagraphy/mass 
spectrometry/mass spectrometry (LC/MS/MC) 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: residuemethods@epa.gov.

B. International Residue Limits

    There are no international residue limits that affect the Agency's 
recommendations at this time. There are no Canadian, CODEX or Mexican 
maximum residue limits (MRLs) for chlorantraniliprole that exists at 
this time.

C. Response to Comments

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

D. Revisions to Petitioned-For Tolerances

    EPA has determined that the appropriate tolerance level for the 
tree nut group and pistachios is 0.04 ppm. Residue field trial data for 
chloroantraniliprole on almonds and pecans showed that the highest 
observed residue level on nutmeats was 0.016 ppm. Almonds and pecans 
are representative commodities for the tree nut group and pistachios. 
Evaluation of these field trial data with EPA's statistical modeling 
procedures for field residue data indicates that a tolerance of 0.04 
ppm will be sufficient for the labeled uses on tree nuts and 
pistachios.
    The petitioner has requested a tolerance of 0.07 ppm for these 
commodities. A higher value was requested because the field trials were 
conducted without use of an adjuvant but the petitioner now seeks 
approval of a pesticide label allowing the use of

[[Page 30474]]

adjuvants. Adjuvants may increase residue levels of the pesticide by 
altering the pattern of deposition, retention and penetration. In the 
case of chlorantraniliprole, several supervised side-by-side studies 
conducted on grape, peach, plum, and cherry with chlorantraniliprole 
alone and in the presence of an adjuvant, methylated seed oils or non-
ionic surfactants showed that the adjuvants increased the level of 
chlorantraniliprole by an average factor of 2.1. EPA does not believe, 
however, that use of an adjuvant would increase chlorantraniliprole 
residues in nutmeats from the tree nut crop group and pistachios 
because these foods have very limited exposure to an applied non-
systemic chemical such as chlorantraniliprole due to the physical 
barrier, known as the exocarp (i.e., husk or hull), surrounding the 
edible commodity. Thus, the Agency does not expect any increase in 
residue with the use of an adjuvant on the tree nut group or pistachios 
and EPA has revised the requested tolerance amount for these 
commodities downward to 0.04 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of 
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-[(methylamino) 
carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1 H-pyrazole-5-carboxamide, 
in or on almond, hulls at 5.0 ppm, nut, trees, group 14 at 0.04 ppm and 
pistachios at 0.04 ppm. In addition, time-limited rotational crop 
tolerances are established for residues of chlorantraniliprole in or on 
cowpeas, forage and hay at 0.20 parts per million (ppm); field peas, 
vines and hay at 0.20 ppm; forage, fodder and straw of cereal grains, 
crop group 16 at 0.20 ppm, grass forage, fodder and hay, crop group 17 
at 0.20 ppm; leaves of root and tuber vegetables, crop group 2 at 0.20 
ppm; leeks at 0.20 ppm; nongrass animal feeds (forage, fodder, straw 
and hay), crop group 18 at 0.20 ppm; okra at 0.70 ppm; onions, green at 
0.20 ppm; onions, Welsh at 0.20 ppm; peanuts, hay at 0.20 ppm; shallots 
at 0.20 ppm; soybeans, forage and hay at 0.20 ppm; strawberries at 1.2 
ppm; and sugarcane, sugar at 0.20 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).
    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).
    Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), the Agency hereby certifies that this proposed action will not 
have significant negative economic impact on a substantial number of 
small entities. Establishing a pesticide tolerance or an exemption from 
the requirement of a pesticide tolerance is, in effect, the removal of 
a regulatory restriction on pesticide residues in food and thus such an 
action will not have any negative economic impact on any entities, 
including small entities.

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: June 11, 2009.
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 180.628 is amended by alphabetically adding the following 
commodities to the table in paragraph (a), and revising paragraph (d) 
to read as follows:

Sec.  180.628  Chlorantraniliprole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Almond, hulls........................................                5.0
                                * * * * *
Nut, tree, group 14..................................               0.04
                                * * * * *
Pistachio............................................               0.04
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (d) Indirect or inadvertent residues. Time-limited tolerances are 
established for indirect or inadvertent residues of the insecticide 
chlorantraniliprole (3-bromo- N -[4-chloro-2-methyl-6-

[[Page 30475]]

[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide) in or on the following commodities. The tolerances will 
expire and are revoked on the dates specified in the following table.

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Animal feed, nongrass, group 18...               0.20           04/10/10
Cowpea, forage....................               0.20           04/10/10
Cowpea, hay.......................               0.20           04/10/10
Field pea, hay....................               0.20           04/10/10
Field pea, vine...................               0.20           04/10/10
Grain, cereal, forage, fodder and                0.20           04/10/10
 straw, group 16..................
Grass, forage, fodder and hay,                   0.20           04/10/10
 group 17.........................
Leek..............................               0.20           04/10/10
Okra..............................               0.70           04/10/10
Onion, green......................               0.20           04/10/10
Onion, Welsh......................               0.20           04/10/10
Peanut, hay.......................               0.20           04/10/10
Shallot...........................               0.20           04/10/10
Soybean, forage...................               0.20           04/10/10
Soybean, hay......................               0.20           04/10/10
Strawberry........................               1.20           04/10/10
Sugarcane.........................               0.20           04/10/10
Vegetable, leaves of root and                    0.20           04/10/10
 tuber, group 2...................
------------------------------------------------------------------------

[FR Doc. E9-14996 Filed 6-25-09; 8:45 am]
BILLING CODE 6560-50-S