[Federal Register Volume 79, Number 26 (Friday, February 7, 2014)]
[Rules and Regulations]
[Pages 7397-7401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02568]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0235; FRL-9905-56]


Chlorantraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
insecticide chlorantraniliprole in or on multiple commodities which are 
identified and discussed later in this document. In addition, this 
regulation revises existing tolerances in or on papaya, passionfruit, 
and spice subgroup 19B, and removes several previously established 
tolerances that will be superseded by tolerances established by this 
action. The Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective February 7, 2014. Objections and 
requests for hearings must be received on or before April 8, 2014, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2013-0235, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090. email 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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/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-2013-0235 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 
April 8, 2014. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0235, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of June 5, 2013 (78 FR 33785) (FRL-9386-2), 
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 3F8158) 
by DuPont Crop Protection, Stine-Haskell Research Center, P.O. Box 30, 
Newark, DE 19714. 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-pyrozole-5-
carboxamide, in or on peanuts at 0.06 parts per million (ppm) and 
peanut, hay at 90 ppm. That document referenced a summary of the 
petition prepared by 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.
    Additionally, in the Federal Register of July 19, 2013 (78 FR 
43115) (FRL-9392-9), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP 3E8170) by Interregional Research Project Number 4 (IR-4), 
500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition 
requested that 40 CFR 180.628 be amended by establishing tolerances for 
residues of the insecticide chlorantraniliprole in or on fruit, stone, 
group 12-12, except cherry, chickasaw

[[Page 7398]]

plum, and damson plum at 4.0 ppm; nut, tree, group 14-12 at 0.04 ppm; 
papaya at 4.0 ppm; passionfruit at 4.0 ppm; and onion, green, subgroup 
3-07B at 3.0 ppm. The petition also requested that tolerances for 
spice, subgroup 19B be increased to 40 ppm; and papaya and passionfruit 
be increased to 4.0 ppm. IR-4 is seeking to raise the tolerance on 
spice, subgroup 19B based on additional residue data on dill seed; IR-4 
is seeking to raise the tolerances on papaya and passionfruit as a 
result of the request to shorten the existing pre-harvest intervals 
(PHIs) for the accompanying use directions for these commodities. That 
document referenced a summary of the petition prepared on behalf of IR-
4 by 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.
    EPA was petitioned for a tolerance in or on fruit, stone, group 12-
12, except cherry, chickasaw plum, and damson plum at 4.0 ppm; however, 
the proposed tolerance was incorrectly transcribed in the Federal 
Register Notice of the filing of the petition to propose a tolerance in 
or on fruit, stone, group 12, except cherry, chickasaw plum, and damson 
plum. However, the summary available in the docket lists stone fruit 
group 12-12, except cherry, chickasaw plum, and damson plum. EPA 
assessed the correct proposed tolerance on crop group 12-12 rather than 
crop group 12, for which there is already an established tolerance.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerances for several commodities. The reasons 
for these changes are explained in Unit IV.C. Additionally, IR-4 later 
withdrew the request to establish a tolerance for tree nut group 14-12.

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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 their 
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 does not exhibit immunotoxicity, neurotoxicity, 
carcinogenicity, or developmental toxicity. Additionally, no 
mutagenicity concerns were reported in the genotoxicity studies.
    In oral and dermal toxicity studies in rats, minimally increased 
microvesiculation of adrenal cortex was observed mostly in males; 
however, supporting data demonstrated no effect on the capacity of the 
adrenal gland to produce corticosterone following stimulation. 
Therefore, adrenal cortex effects observed in rat studies were not 
considered adverse.
    Chlorantraniliprole does not exhibit prenatal or postnatal toxicity 
as there were no maternal or fetal effects in studies conducted in rats 
and rabbits. The relative absence of mammalian hazard may be due in 
part to chlorantranilprole's selectivity for insect ryanodine receptor 
(RyR) over mammalian counterparts. In short-term mammalian studies, the 
most consistent effects are increased liver weights and mild induction 
of liver enzymes.
    Chlorantraniliprole is classified as not likely to be carcinogenic 
to humans, based on the weight of evidence of the data. No treatment-
related tumors were reported in the submitted chronic and oncogenicity 
studies in rats and mice (18-month carcinogenicity study) or in the 
subchronic studies in mice, dogs, and rats.
    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: Human Health 
Risk Assessment for Proposed Uses on Green Onion Subgroup 3-07b, and 
Peanut; for the Requests to Update the Crop Groups of Stone Fruit, Tree 
Nut, and Spices; to Shorten the Pre-Harvest Intervals for Papaya, 
Passionfruit, and Mayhaw; and Evaluation of Condition of Registration 
Data on Rice, Coffee, Strawberry, and Tropical Fruits'' at pp. 25-30 in 
docket ID number EPA-HQ-OPP-2013-0235.

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 discussed in Unit III.B. of the final 
rule published in the Federal Register of July 27, 2011 (76 FR 44815) 
(FRL-8875-5).

[[Page 7399]]

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) 2003-2008 National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEA). As 
to residue levels in food, EPA assumed tolerance-level residues for the 
proposed and registered crops, and assumed 100 percent crop treated 
(PCT) for all commodities. Where processing data indicated a reduction 
(or no increase) in residue upon processing, the residue level of the 
raw agricultural commodity (RAC) was used without reduction for the 
processed commodity, for example mint oil from spearmint. Where 
processing data indicated an increase in residue in the processed 
commodity, tolerance-level residues based on tolerances established for 
those processed commodities were used, e.g., raisins from grapes. 
However, if residues do not concentrate or where processing data 
indicated a reduction in residues upon processing, the tolerance for 
the RAC is used without reduction and a separate tolerance for the 
processed commodity is not needed. Where adequate processing data do 
not exist, Dietary Risk Evaluation System (DEEM) default concentration 
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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and PRZM Groundwater (GW) models, the estimated 
drinking water concentrations (EDWCs) of chlorantraniliprole for 
chronic exposures for non-cancer assessments are estimated to be 39.87 
parts per billion (ppb) for surface water and 207 ppb for groundwater.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. No acute dietary risk 
assessment was performed because no acute hazard was identified. For 
chronic dietary risk assessment, the water concentration value of 207 
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: Sod farms/turf, landscape 
ornamentals and interiorscapes, and as a termiticide. Residential 
exposure is expected to occur for short-term and intermediate-term 
durations; however, due to the lack of toxicity identified for short- 
and intermediate-term durations via relevant routes of exposure, 
residential exposure was not assessed. 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 chemicals, see EPA's Web site at 
http:[sol][sol]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 Food Quality 
Protection Act (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 
prenatal fetal growth or postnatal 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. Moreover, there 
were no treatment related effects on the numbers of litters, fetuses 
(live or dead), resorptions, sex ratio, or post-implantation losses. 
There were 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 uncertainty factor (UFs) to account for neurotoxicity.

[[Page 7400]]

    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 chronic dietary assessment utilized tolerance-level 
residues for all crops and assumed that 100 PCT of the proposed and 
registered crops were treated with chlorantraniliprole. Default 
processing factors were used, as appropriate. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to chlorantraniliprole in drinking water. Moreover, 
there is a lack of toxicity via the dermal route, as well as a lack of 
toxicity over the acute-, short- and intermediate-term via the oral 
route of exposure. 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 
acute PAD (aPAD) and chronic PAD (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 6.7% 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 and intermediate-term risk. Short-term and 
intermediate-term aggregate exposures take into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Because no 
short-term or intermediate-term adverse effects were identified, the 
aggregate short-term or intermediate-term risk is the same as the 
dietary risk, which will not be greater than the chronic aggregate 
risk.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, chlorantraniliprole is not expected to pose a cancer risk to 
humans.
    5. 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); Method DuPont-11374, 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; email 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 United Nations 
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.
    Codex has not established chlorantraniliprole MRLs for 
passionfruit, papaya, peanuts, green onions, or spice commodities. EPA 
cannot harmonize the requested tolerance for stone fruit group 12-12, 
except cherry, chickasaw plum, and damson plum with the Codex MRL for 
stone fruit, because the permitted domestic use on these crops in 
accordance with the approved pesticide label results in residue levels 
higher than the Codex MRL; EPA will not set tolerances at levels that 
could result in legally treated food in the United States bearing 
residues in excess of the approved tolerance.

C. Revisions to Petitioned-For Tolerances

    Based on the data supporting the petition, EPA has revised the 
following proposed tolerance level: Spice subgroup 19B from 40 ppm to 
90. The Agency revised this tolerance level based on analysis of the 
residue field trial data using the Organization for Economic 
Cooperation and Development tolerance calculation procedures.

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)-1H-pyrozole-5-
carboxamide, including its metabolites and degradates, in or on fruit, 
stone, group 12-12, except cherry, chickasaw plum, and damson plum at 
4.0 ppm; onion, green subgroup 3-07B at 3.0 ppm; peanut, hay at 90 ppm; 
and peanut at 0.06 ppm. This regulation additionally revises previously 
established tolerances in or on the following commodities: Papaya from 
2.0 ppm to 4.0 ppm; passionfruit from 2.0 ppm to 4.0 ppm; and spice 
subgroup 19B from 14 ppm to 90 ppm. Finally, this regulation removes 
established permanent tolerances or time-limited tolerances for the 
indirect or inadvertent residues of chlorantraniliprole in or on fruit, 
stone, group 12, except cherry, chickasaw plum, and damson plum at 4.0 
ppm; leek at 0.20 ppm; onion, green at 0.20 ppm; onion, welsh at 0.20 
ppm; peanut, hay at 0.20 ppm; and shallots, fresh leaves at 0.20 ppm.
    Fruit, stone, group 12, except cherry, chickasaw plum, and damson 
plum is being removed because the group 12-12 tolerance being 
established, includes all commodities in group 12 at the same tolerance 
level. Leek; onion, green; onion, welsh; and shallots, fresh leaves are 
being removed because each of these commodities are included in the 
subgroup 3-07B, which is being established at 3.0 ppm, a level higher 
than the time-limited tolerances for the inadvertent residues of 
chlorantraniliprole in or on these commodities.

[[Page 7401]]

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: January 31, 2014.
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. In Sec.  180.628:
0
a. Remove the entry ``Fruit, stone, group 12, except cherry, chickasaw 
plum, and damson plum'' in the table in paragraph (a).
0
b. Add the entries: ``Fruit, stone, group 12-12, except cherry, 
chickasaw plum, and damson plum''; ``Onion, green, subgroup 3-07B''; 
``Peanut, hay''; and ``Peanut'' to the table in paragraph (a).
0
c. Revise the entries ``Papaya'', ``Passionfruit'', and ``Spice, 
subgroup 19B'' in the table in paragraph (a).
0
d. Remove and reserve paragraph (d).
    The amendments read as follows:


Sec.  180.628  Chlorantraniliprole; tolerances for residues.

    (a) * * *





------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fruit, stone, group 12-12, except cherry, chickasaw plum,           4.0
 and damson plum...........................................
 
                                * * * * *
Onion, green, subgroup 3-07B...............................         3.0
Papaya.....................................................         4.0
Passionfruit...............................................         4.0
Peanut.....................................................         0.06
Peanut, hay................................................        90
 
                                * * * * *
Spice, subgroup 19B........................................        90
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2014-02568 Filed 2-6-14; 8:45 am]
BILLING CODE 6560-50-P