Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Rules and Regulations 60311 

[FR Doc. 2012–23988 Filed 10–2–12; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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. 


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60312 Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Rules and Regulations 

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-effectlevel (NOAEL) and the lowest-observedadverse-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 nonVerDate Mar<15>2010 14:51 Oct 02, 2012 Jkt 229001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\FR\FM\03OCR1.SGM 03OCR1

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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 nonoccupational, 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 postimplantation 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 intermediateterm 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. 


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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 × 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 


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Federal Register / Vol. 77, No. 192 / Wednesday, October 3, 2012 / Rules and Regulations 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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.628 is amended as 

follows: 

■ 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). 

■ 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). 

■ 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). 

■ iv. Remove the entries for soybean, 

forage, and soybean, hay, from the table 

in paragraph (d). 

The added and revised text read as 

follows: 

§ 180.628 Chlorantraniliprole; tolerances 

for residues. 

Commodity Parts per 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 412, 413, 424, and 476 

[CMS–1588–CN2] 

RIN 0938–AR12 

Medicare Program; Hospital Inpatient 

Prospective Payment Systems for 

Acute Care Hospitals and the LongTerm Care Hospital Prospective 

Payment System and Fiscal Year 2013 

Rates; Hospitals’ Resident Caps for 

Graduate Medical Education Payment 

Purposes; Quality Reporting 

Requirements for Specific Providers 

and for Ambulatory Surgical Centers; 

Corrections 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule; correction. 

SUMMARY: This document corrects 

technical errors in the final rule that 

appeared in the August 31, 2012 

Federal Register entitled ‘‘Medicare 

Program; Hospital Inpatient Prospective 

Payment Systems for Acute Care 

Hospitals and the Long-Term Care 

Hospital Prospective Payment System 

and Fiscal Year 2013 Rates; Hospitals’ 

Resident Caps for Graduate Medical 

Education Payment Purposes; Quality 

Reporting Requirements for Specific 

Providers and for Ambulatory Surgical 

Centers.’’ 

DATES: Effective Date: October 1, 2012. 

FOR FURTHER INFORMATION CONTACT: Tzvi 

Hefter, (410) 786–4487. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In FR Doc. 2012–19079 of August 31, 

2012 (77 FR 53258), there were a 

number of technical errors that are 

identified and corrected in the 

Correction of Errors section of this 

correcting document. The provisions in 

this correcting document are effective as 

if they had been included in the final 

rule appearing in the August 31, 2012 

Federal Register. Accordingly, the 

corrections are effective October 1, 

2012. 

II. Summary of Errors and Corrections 

Posted on the CMS Web Site 

A. Errors in the Preamble 

On page 53268, in our summary of the 

provisions of the Hospital Inpatient 

Quality Reporting (IQR) Program, we 

inadvertently referenced hospitalacquired condition (HAC) measure sets 


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