
[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Rules and Regulations]
[Pages 60311-60315]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24152]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0029; FRL-9362-5]


Chlorantraniliprole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
chlorantraniliprole in or on multiple commodities which are identified 
and discussed later in this document. E.I. DuPont de Nemours and 
Company, DuPont Crop Protection, requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 3, 2012. Objections and 
requests for hearings must be received on or before December 3, 2012, 
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-2012-0029, 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: Jennifer Urbanski, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 347-0156; email address: 
urbanski.jennifer@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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2012-0029 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 
December 3, 2012. 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-2012-0029, 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 Confidential Business 
Information (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.htm.
    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 April 4, 2012 (77 FR 20344) (FRL-9340-
4), 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 
1F7954) by E.I. DuPont de Nemours and Company, DuPont Crop Protection, 
1007 Market Street, Wilmington, DE 19898. The petition requested that 
40 CFR 180.628 be amended by establishing tolerances for residues of 
the insecticide chlorantraniliprole,3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide, in or on oilseed, rapeseed subgroup 20A at 2.0 parts per 
million (ppm); oilseed, sunflower subgroup 20B at 2.0 ppm; oilseed, 
cottonseed subgroup 20C at 0.3 ppm; soybean aspirated grain fractions 
at 300 ppm; vegetable, legume, group 6 at 2.0 ppm; vegetable, foliage 
of legume, group 7 at 30 ppm; and forage, vegetable, foliage of legume, 
group 7 at 90 ppm. That document referenced a summary of the petition 
prepared by E. I. DuPont de Nemours and Company, the registrant, which 
is available in the docket, http://www.regulations.gov. Comments were 
received on the notice of filing. EPA's response to these comments is 
discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerance associated with aspirated grain fractions to 640 
ppm. EPA is also increasing the existing tolerances in cattle, fat; 
goat, fat; horse, fat; and sheep, fat to 0.5 ppm. EPA has also 
increased the existing tolerances in cattle, meat; goat, meat; horse, 
meat; and sheep, meat to 0.1 ppm. The reason for these changes are 
explained in Unit IV.D.

[[Page 60312]]

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 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 developmentally toxic. 
Chlorantraniliprole is not acutely toxic via oral, dermal or inhalation 
routes of exposure, and is not an eye or skin irritant nor a dermal 
sensitizer. There was only one animal toxicity study (18-month 
carcinogenicity study in mice) in the toxicology database which 
evidenced any adverse effect of chlorantraniliprole. This study was 
used to establish a point of departure (POD), based on hepatocellular 
effects, for the chronic dietary exposure scenario. Although 
residential and occupational exposure is expected over the short- and 
intermediate-term (via the dermal and/or incidental oral route), there 
is no hazard expected via these routes/durations, and therefore no risk 
associated with these scenarios.
    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 Oilseeds (Subgroups 20A through C) 
and Soybean (Crop group 6 and 7),'' page 16 in docket ID number EPA-HQ-
OPP-2012-0029.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological 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) 1994-1996 and 1998 Continuing Survey 
of Food Intake by Individuals (CSFII). As to residue levels in food, 
EPA assumed tolerance levels residues and 100% crop treated (CT). 
Dietary Risk Evaluation System (DEEM) default processing factors were 
used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that chlorantraniliprole does not pose a cancer risk to 
humans. Therefore, a dietary exposure assessment for the purpose of 
assessing cancer risk is unnecessary.
    iv. Anticipated residue and 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% CT 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 acute exposures are estimated to be 55.30 parts 
per billion (ppb) for surface water and 0.842 ppb for ground water, and 
for chronic exposures for cancer and non-

[[Page 60313]]

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. For chronic dietary risk 
assessment, the water concentration of value 39.87 ppb was used to 
assess the contribution to drinking water. No acute dietary risk 
assessment was performed because no acute hazard was identified.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Chlorantraniliprole 
is currently registered for the following uses that could result in 
residential exposures: Termiticide, ornamentals, and turfgrass. EPA 
assessed residential exposure using the following assumptions: 
Residential exposure could 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, no 
risk is expected from these exposures. 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 Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There were no effects on 
fetal growth or postnatal development up to the limit dose of 1,000 
milligrams/kilogram/day (mg/kg/day) in rats or rabbits in the 
development 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. A poultry feeding study is needed, but the results of the 
poultry metabolism study conducted at a feeding level twice the 
expected dietary burden and at a duration of 14 days, well in excess of 
the mandatory 3 days, are used to provide a conservative estimate of 
residues in poultry commodities. The dietary food exposure assessments 
were performed based on 100% CT and tolerance-level residues. 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 
postapplication exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by chlorantraniliprole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
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% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
chlorantraniliprole is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Because no 
short-term adverse effect was identified, chlorantraniliprole is not 
expected to pose a short-term 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). Because no intermediate-term adverse effect was identified, 
chlorantraniliprole is not expected to pose a intermediate-term risk.
    5. 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.

[[Page 60314]]

    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to chlorantraniliprole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography mass 
spectrometry (LC/MS/MS)) is available to enforce the tolerance 
expression. The method may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; 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.
    The Codex has established MRLs for chlorantraniliprole in or on the 
oilseed cottonseed subgroup 20C at 0.3 ppm. This MRL is the same as the 
tolerance being established for chlorantraniliprole the oilseed 
cottonseed subgroup 20C in the United States by this action.
    The Codex has established MRLs for chlorantraniliprole in or on 
meat (fat) at 0.2 ppm. These MRLs are different than the tolerances 
being established for chlorantraniliprole in the United States on 
cattle, horse, sheep and goat fat (0.5 ppm) by this action. This 
results from the differences in treated commodities used in the 
livestock dietary exposure calculation and in the methods of diet 
calculation. The United States tolerances include more livestock feed 
items than Codex. Codex calculates the dietary burden based on the 
worst possible case, whereas NAFTA countries utilize a reasonably 
balanced diet that considered nutritional needs of livestock.

C. Response to Comments

    The EPA received a comment from a private citizen stating that 
pesticides should be banned. The Agency understands the commenter's 
concerns and recognizes that some individuals believe that pesticides 
should be banned completely. However, under the existing legal 
framework provided by section 408 of the Federal Food, Drug and 
Cosmetic Act (FFDCA) EPA is authorized to establish pesticide 
tolerances or exemptions where persons seeking such tolerances or 
exemptions have demonstrated that the pesticide meets the safety 
standard imposed by that statute.

D. Revisions to Petitioned-for Tolerances

    The petition requested an aspirated grain fractions tolerance of 
300 ppm. EPA is establishing a 640 ppm tolerance in aspirated grain 
factions based on evaluation of the soybean processing data. A 
processing study submitted for the generation of aspirated grain dust 
from soybeans provided a processing factor (320) that was used with the 
crop group 6 tolerance (2.0 ppm) to obtain a tolerance estimate (320 x 
2 = 640 ppm) for aspirated grain fractions. Thus, soybeans with 
residues at the tolerance level (2 ppm) would yield aspirated grain 
fractions with residues of 640 ppm.
    EPA is increasing the tolerance levels for certain livestock 
commodities because of the addition of soybean aspirated grain 
fractions as a feed item and the resulting increase in certain 
livestock dietary burdens. Previously, aspirated grain fractions (corn) 
contributed to the dietary burden; this is now replaced by soybean 
aspirated grain fractions which results in a greater dietary 
contribution. The beef cattle dietary burden is now elevated from 73 
ppm to 110 ppm. This increase in the cattle dietary burden necessitates 
an increase in the tolerances of the meat and fat of cattle, sheep, 
horses, and goats. The existing tolerances for liver and kidney will 
cover the increased dietary exposure of cattle. The milk tolerance is 
not affected, because aspirated grain fractions are not a significant 
diary cow feed item.

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, in or on the following commodities: oilseed, rapeseed 
subgroup 20A at 2.0 ppm; oilseed, sunflower subgroup 20B at 2.0 ppm; 
oilseed, cottonseed subgroup 20C at 0.3 ppm; soybean aspirated grain 
fractions at 640 ppm; vegetable, legume, group 6 at 2.0 ppm; vegetable, 
foliage of legume, group 7, forage at 30 ppm; vegetable, foliage of 
legume, group 7, hay at 90 ppm; cattle, goat, horse and sheep, fat at 
0.5 ppm, and cattle, goat, horse and sheep, meat at 0.1 ppm. Consistent 
with the petitioner's request, EPA is also deleting certain 
chlorantraniliprole tolerances that are no longer needed as a result of 
the crop group tolerances added by this action.

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 tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this

[[Page 60315]]

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 21, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. Section 180.628 is amended as follows:
0
i. Remove the entries for crambe, seed; grain, aspirated fractions; 
hare's ear mustard, seed; jojoba, seed; lesquerella, seed; milkweed, 
seed; mustard, seed; oil, radish, seed; poppy, seed; rapeseed, seed; 
rose hip, seed; sesame, seed; tallowwood, seed; tea oil plant, seed; 
vegetable, foliage of legume, except soybean, subgroup 7A, forage; 
vegetable, foliage of legume, except soybean, subgroup 7A, hay; and 
vegetable, legume, group 6, except soybeans; from the table in 
paragraph (a).
0
ii. Revise the tolerances for cattle, fat; cattle, meat; goat, fat; 
goat, meat; horse, fat; horse, meat; sheep, fat; sheep, meat; in the 
table in paragraph (a).
0
iii. Add alphabetically entries for cottonseed subgroup 20C, grain, 
aspirated grain fractions; rapeseed subgroup 20A; sunflower subgroup 
20B; vegetable, legume, group 6; vegetable, foliage of legume, group 7, 
forage; and vegetable, foliage of legume, group 7, hay; to the table in 
paragraph (a).
0
iv. Remove the entries for soybean, forage, and soybean, hay, from the 
table in paragraph (d).
    The added and revised text read as follows:


Sec.  180.628  Chlorantraniliprole; tolerances for residues.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cattle, fat................................................          0.5
Cattle, meat...............................................          0.1
 
                                * * * * *
Cottonseed subgroup 20C....................................          0.3
 
                                * * * * *
Goat, fat..................................................          0.5
Goat, meat.................................................          0.1
 
                                * * * * *
Grain, aspirated grain fractions...........................          640
 
                                * * * * *
Horse, fat.................................................          0.5
Horse, meat................................................          0.1
 
                                * * * * *
Rapeseed subgroup 20B......................................          2.0
 
                                * * * * *
Sheep, fat.................................................          0.5
Sheep, meat................................................          0.1
 
                                * * * * *
Sunflower subgroup 20C.....................................          0.3
 
                                * * * * *
Vegetable, legume, group 6.................................          2.0
Vegetable, foliage of legume, group 7, forage..............           30
Vegetable, foliage of legume, group 7, hay.................           90
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-24152 Filed 10-2-12; 8:45 am]
BILLING CODE 6560-50-P


