[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Rules and Regulations]
[Pages 57280-57285]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22593]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0635; FRL-9395-1]


Chlorantraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

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 removes established tolerances for certain commodities/
groups superseded by this action.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 September 18, 2013. Objections and 
requests for hearings must be received on or before November 18, 2013, 
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-2012-0635, 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

[[Page 57281]]

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: RDFRNotices@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. 
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-2012-0635 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 
November 18, 2013. 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-2012-0635, 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 Tolerance

    In the Federal Register of Wednesday, November 7, 2012 (77 FR 
66781) (FRL-9367-5), 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 2E8064) by Interregional Research Project Number 4 (IR-4), 
IR-4 Project Headquarters, 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, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide, including its metabolites and degradates, in or on cereal 
grain group 15, except rice at 6.0 parts per million (ppm); grain, 
cereal, forage, fodder and straw, group 16 at 30.0 ppm; fruit, citrus, 
group 10-10 at 1.4 ppm; and fruit, pome, group 11-10 at 1.2 ppm. In 
addition, petition 2E8064 proposed, upon approval of above tolerances, 
to remove established tolerances in or on the raw agricultural 
commodities/groups: Mayhaw at 0.6 ppm; field corn forage, field corn 
stover, pop corn forage, pop corn stover, sweet corn forage, sweet corn 
stover at 14 ppm; field corn grain, pop corn grain at 0.04 ppm; sweet 
corn kernels plus cob with husk removed at 0.02 ppm; field corn milled 
byproducts at 0.1 ppm; citrus fruit group 10 at 1.4 ppm; and pome fruit 
group 11 except mayhaw at 1.2 ppm. That document referenced a summary 
of the petition prepared by E. I. DuPont 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 
modified, removed and/or established chlorantraniliprole tolerances for 
certain commodities. The reasons for these changes are explained in 
Unit IV.C.

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

[[Page 57282]]

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.
    No mutagenicity concerns were reported in the genotoxicity studies. 
Nor does chlorantraniliprole exhibit immunotoxicity, neurotoxicity, 
carcinogenicity, or developmental toxicity.
    In oral and dermal toxicity studies in rats, minimally increased 
microvesiculation of adrenal cortex was observed in males only; 
however, supporting data demonstrated no effect on the capacity of the 
adrenal gland to produce corticosterone under either basal or following 
adrenocorticotropic hormone (ACTH) stimulation. Therefore, adrenal 
cortex effects observed in rat studies were not considered adverse.
    Chlorantraniliprole does not exhibit pre- 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 studies, the most 
consistent effects are those associated with non-adverse 
pharmacological response to the xenobiotic, induction of liver enzymes 
and subsequent increase in liver weights.
    Chlorantraniliprole is classified as ``Not likely to be 
Carcinogenic to Humans'' based on the weight of evidence of 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 Cereal Grains Group 15 (except 
Rice) and Cereal Grains Forage, Fodder, and Straw Group 16, and 
Conversion of Citrus and Pome Fruit Groups,'' dated May 12, 2013 at 
p.25 in docket ID number EPA-HQ-OPP-2012-0635-0005.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for 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).

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 levels residues for 
the proposed and registered crops, and assumed 100 percent crop treated 
(PCT). 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 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 commodities were used, e.g., raisins from grapes. 
Where adequate processing data did not exist, Dietary Risk Evaluation 
System (DEEM) default concentration factors were used if available.
    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 percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for chlorantraniliprole. Tolerance level residues and 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 estimated drinking water concentrations (EDWCs) of 
chlorantraniliprole for chronic exposures for non-cancer assessments 
are estimated to be 39.87 ppb for surface water and 0.842 ppb for 
ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. No acute dietary risk 
assessment was

[[Page 57283]]

performed because no acute hazard was identified. For chronic dietary 
risk assessment, the water concentration value of 39.87 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: Termiticide, sod farms/
turf, landscape ornamentals and interiorscapes. 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://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. 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 
development 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 loss. 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 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 chronic dietary assessment utilized tolerance level 
residues for all crops and assumed 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 the lack 
of toxicity over the acute-, short- and intermediate-term via the oral 
route. 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 6.3% 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.

[[Page 57284]]

    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: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by 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 established chlorantraniliprole maximum residue limits 
(MRLs) for a number of crop and animal commodities. The Codex MRLs for 
cereal grains, citrus fruit, and pome fruit are significantly lower 
than the recommended corresponding US tolerances. Because the permitted 
domestic use on these crops in accordance with the approved pesticide 
label results in residue levels higher than the Codex MRLs, the US 
tolerance cannot be harmonized (lowered) since doing so would result in 
residues in excess of the approved tolerance in spite of use consistent 
with label directions. Because the US tolerances for cereal grains are 
higher than the Codex MRLs for cereal grains, the US livestock 
tolerances at the values recommended are necessary to encompass 
possible residue levels from use of the pesticide according to label 
directions.

C. Revisions to Petitioned-for Tolerances

    EPA converted, modified, removed and/or established 
chlorantraniliprole tolerances for certain commodities and, in some 
cases, re-defined the crop group tolerance expression and/or corrected 
the commodity definition, as needed.
    EPA determined that the proposed tolerance for grain, cereal, group 
15, except rice at 6.0 ppm is not appropriate. Establishing the 
proposed tolerance would raise tolerance levels for corn, field, grain; 
corn, pop, grain, and corn, sweet, kernel plus cobs with husk removed 
much in excess of their actual residue levels: corn, field, grain and 
corn, pop, grain at 0.04 ppm and corn, sweet, kernel plus cobs with 
husk removed at 0.02 ppm. Therefore, the Agency determined that the 
grain, cereal, group 15 tolerance must exclude corn (including corn, 
field, grain; corn, pop, grain; and corn, sweet), and re-defined the 
crop group tolerance expression as ``grain, cereal, group 15, except 
rice and corn'' at 6.0 ppm. Accordingly, although the petitioner 
requested the removal of the established tolerances for corn, field, 
grain at 0.04 ppm and corn, pop, grain at 0.04 ppm and field corn 
milled byproducts at 0.1 ppm because they would be subsumed within the 
proposed tolerance for grain, cereal, group 15, EPA is not leaving 
those tolerances in place.
    Based on field trial data and using the Organization of Economic 
Cooperation and Development (OECD) tolerance calculation procedures, 
EPA determined that the proposed tolerance on grain, cereal, forage, 
fodder, and straw, group 16 at 30 ppm should be increased 40 ppm.
    Upon the establishment of fruit, pome, group 11-10, the petitioner 
proposed that the tolerance for fruit, pome, group 11 and mayhaw, be 
deleted. The existing tolerance is for fruit, pome, group 11, except 
mayhaw at 1.2 ppm and there is a separate tolerance for mayhaw at 0.6 
ppm. These two tolerances will now be superseded by establishment of 
the group tolerance ``fruit, pome, group 11-10'' at 1.2 ppm.
    The tolerances for certain livestock commodities were created or 
increased because expanded use of chlorantraniliprole to more cereal 
grains and cereal grain forages, fodders, and straws increased the 
dietary exposure of livestock. The increased dietary exposure of 
livestock necessitates increased tolerances for cattle, sheep, horse, 
and goat meat byproducts from 0.2 ppm to 0.5 ppm and for milk from -
0.05 ppm to 0.1 ppm. Due to elevated hog dietary exposure from the crop 
group tolerance for grain, cereal, group 15, EPA established a hog, 
meat tolerance at 0.02 ppm and increased both the hog, fat and the hog, 
meat byproducts tolerance from 0.02 to 0.05 ppm. Likewise, the grain, 
cereal, group 15 elevated the laying hen dietary exposure and, 
consequently, the Agency set a tolerance for poultry, meat at 0.05 ppm 
and increased the tolerance for egg from 0.2 to 1.0 ppm; poultry, fat 
from 0.01 to 0.2 ppm; and poultry, meat byproducts from 0.02 to 0.2 
ppm. In accordance with the Agency commodity terminology, EPA is re-
defining existing animal ``meat byproducts, except liver'' tolerances 
to ``meat byproducts'', which includes liver. Thus, EPA is deleting 
separate tolerances for goat, liver, horse, liver, and sheep, liver 
since they are covered by the respective meat byproducts tolerances.
    Lastly, at 180.628(d), the Agency removed the entry for commodity 
``Grain, cereal, forage, fodder and straw, group 16 at 0.20 ppm, with 
expiration/revocation date of 04/10/14, as this time-limited tolerance 
is superseded by this action.

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-pyrazole-5-
carboxamide, including its metabolites and degradates, in or on Cattle, 
meat byproducts at 0.5 parts per million (ppm); Egg at 1.0 ppm; Fruit, 
citrus, group 10-10 at 1.4 ppm; Fruit, pome, group 11-10 at 1.2 ppm; 
Goat, meat byproducts at 0.5 ppm; Grain, cereal, group 15, except rice 
and corn at 6.0 ppm; Grain, cereal, forage, fodder and straw, group 16 
at 40.0 ppm; Hog, fat at 0.05 ppm; Hog, meat at 0.02 ppm; Hog, meat 
byproducts at 0.05 ppm; Horse, meat byproducts at 0.5 ppm; Milk at 0.1 
ppm; Poultry, fat at 0.2 ppm; Poultry, meat at 0.05 ppm; Poultry, meat 
byproducts at 0.2 ppm; and Sheep, meat byproducts at 0.5 ppm.

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

[[Page 57285]]

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: September 9, 2013.
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.


Sec.  180.628  [Amended]

0
2. Section 180.628, the table in paragraph (a), is amended as follows:
0
i. Remove the following commodities: ``Cattle, liver''; ``Cattle, meat 
byproducts, except liver''; ``Corn, field forage''; ``Corn, field, 
stover''; ``Corn, pop, forage''; ``Corn, pop, stover''; ``Corn, sweet, 
forage''; ``Corn, sweet, stover''; ``Fruit, citrus group 10''; ``Fruit, 
pome group 11, except mayhaw''; ``Goat, liver''; ``Goat, meat 
byproducts, except liver''; ``Horse, liver''; ``Horse, meat byproducts, 
except liver''; ``Mayhaw''; ``Sheep, liver''; and ``Sheep, meat 
byproducts, except liver.''
0
ii. Revise the following commodities: ``Egg''; ``Hog, fat''; ``Hog, 
meat byproducts''; ``Milk''; ``Poultry, fat''; and ``Poultry, meat 
byproducts.''
0
iii. Add alphabetically the commodities: ``Cattle, meat byproducts''; 
``Fruit, citrus, group 10-10''; ``Fruit, pome, group 11-10''; ``Goat, 
meat byproducts''; ``Grain, cereal, except rice and corn, group 15''; 
``Grain, cereal, forage, fodder and straw, group 16''; ``Hog, meat''; 
``Horse, meat byproducts''; Poultry, meat''; and ``Sheep, meat 
byproducts.''

0
3. Section 180.628, the table in paragraph (d) is amended by removing 
the entry ``Grain, cereal, forage, fodder and straw, group 16.''
    The additions and revisions read as follows:


Sec.  180.628  Chlorantraniliprole; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cattle, meat byproducts....................................          0.5
 
                                * * * * *
Fruit, citrus, group 10-10.................................          1.4
Fruit, pome, group 11-10...................................          1.2
 
                                * * * * *
Goat, meat byproducts......................................          0.5
 
                                * * * * *
Grain, cereal, except rice and corn, group 15..............          6.0
Grain, cereal, forage, fodder and straw, group 16..........           40
 
                                * * * * *
Hog, fat...................................................         0.05
Hog, meat..................................................         0.02
Hog, meat byproducts.......................................         0.05
 
                                * * * * *
Horse, meat byproducts.....................................          0.5
 
                                * * * * *
Milk.......................................................          0.1
 
                                * * * * *
Poultry, fat...............................................          0.2
Poultry, meat..............................................         0.05
Poultry, meat byproducts...................................          0.2
 
                                * * * * *
Sheep meat byproducts......................................          0.5
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-22593 Filed 9-17-13; 8:45 am]
BILLING CODE 6560-50-P