5526 Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 

established for residues of spiromesifen 

and its metabolites on the requested 

crops. 

C. Response to Comments 

One comment was received from an 

anonymous citizen who objected to the 

proposed use of spiromesifen because of 

the amounts of pesticides already 

approved and being approved. 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 

Vegetable, bulb, group 3-07. Due to 

the detection of residues on onion after 

performing an extensive rotational crop 

study, Bayer then proposed changing 

the tolerance from 0.07 ppm to 0.09 

ppm. The Agency concurred with this 

proposed tolerance. Using the North 

American Free Trade Agreement 

(NAFTA) Maximum Residue Limits/ 

Tolerance Harmonization Workgroup 

methodology for evaluating field trial 

data, the Agency determined that the 

requested establishment of permanent 

tolerances in/on vegetable, bulb, group 

3-07 proposed at 0.09 ppm should be 

made. 

V. Conclusion 

Therefore, tolerances are established 

for inadvertent or indirect combined 

residues of the insecticide spiromesifen, 

(2-oxo-3-(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-4-yl 3,3- 

dimethylbutanoate), its enol metabolite 

(4-hydroxy-3-(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-2-one), and its 

metabolites containing the 4- 

hydroxymethyl moiety (4-hydroxy-3-[4- 

(hydroxymethyl)-2,6-dimethylphenyl]- 

1-oxaspiro[4.4]non-3-en-2-one), 

calculated as the parent compound 

equivalents, in or on vegetable, bulb, 

group 3-07 at 0.09 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 25, 2010. 

Lois Rossi, 

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 180.607 is amended by 

alphabetically adding the following 

commodity to the table in paragraph (d) 

to read as follows: 

§ 180.607 Spiromesifen; tolerances for 

residues. 

* * * * * 

(d) * * * 

Commodity Parts per 

million 

* * * * * 

Vegetable, bulb, group 3-07 ......... 0.09 

* * * * * 

* * * * * 

[FR Doc. 2010–2144 Filed 2–2–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0261; FRL–8809–3] 

Chlorantraniliprole; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

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Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 5527 

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. This 

regulation additionally amends 

previously established tolerances in or 

on multiple commodities and deletes 

tolerances in or on several commodities 

that will be replaced by this action. E.I. 

du Pont de Nemours and Company, 

DuPont Crop Protection, requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 3, 2010. Objections and 

requests for hearings must be received 

on or before April 5, 2010, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0261. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Kable Bo Davis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 306–0415; e-mail address: 

davis.kabl@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I 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 

cite at http://www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

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–2009–0261 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before April 5, 2010. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0261, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of May 6, 2009 

(Volume 74 FR 20949) (FRL–8412–7), 

EPA issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 9F7513) by E.I. du 

Pont de Nemours and Company, DuPont 

Crop Protection,1090 Elkton Road, 

Newark, DE 19711. The petition 

requested that 40 CFR 180.628 be 

amended by establishing tolerances for 

residues of the insecticide 

chlorantraniliprole, 3-bromo-N-[4- 

chloro-2-methyl-6- 

[(methylamino)carbonyl]phenyl]-1-(3- 

chloro-2-pyridinyl)-1H-pyrazole-5- 

carboxamide, in or on acerola at 2.0 

parts per million (ppm); almond, hull at 

5.0 ppm; apple, wet pomace at 2.5 ppm; 

artichoke at 4.0 ppm; asparagus at 13.0 

ppm; atemoya at 4.0 ppm; avocado at 

4.0 ppm; banana at 4.0 ppm; biriba at 

4.0 ppm; black sapote at 4.0 ppm; cacao 

bean, bean at 0.15 ppm; cacao, roasted 

beans at 1.4 ppm; canistel at 4.0 ppm; 

cattle, fat at 0.3 ppm; cattle, liver at 0.3 

ppm; cattle, meat at 0.05 ppm; cattle, 

meat byproducts except liver at 0.2 

ppm; cherimoya at 4.0 ppm; chocolate 

at 3.0 ppm; citrus, dried pulp at 14.0 

ppm; cocoa powder at 3.0 ppm; coffee, 

bean, green at 0.5 ppm; coffee, instant 

at 2.5 ppm; corn, sweet at 0.02 ppm; 

corn, field, grain at 0.04 ppm; corn, pop 

at 0.04 ppm; corn, aspirated grain 

fractions at 2.0 ppm; corn, processed 

commodities at 0.1 ppm; crambe at 0.3 

ppm; crayfish at 8.0 ppm; custard apple 

at 4.0 ppm; egg at 0.1 ppm; feijoa at 4.0 

ppm; figs at 4.0 ppm; forage, fodder, and 

straw of cereal grains, group 16, forage 

and fodder at 25.0 ppm; forage, fodder, 

and straw of cereal grains, group 16, hay 

and straw at 90.0 ppm; fruit, caneberry, 

subgroup 13–07A at 1.8 ppm; fruit, 

citrus, group 10 at 1.4 ppm; fruit, pome, 

group 11 at 1.2 ppm; fruit, small vine 

climbing, subgroup 13–07D at 2.5 ppm; 

fruit, stone, group 12 at 4.0 ppm; goat, 

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5528 Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 

fat at 0.3 ppm; goat, liver at 0.3 ppm; 

goat, meat at 0.05 ppm; goat, meat 

byproducts, except liver at 0.2 ppm; 

grass, forage, fodder and hay, group 17, 

forage and fodder at 25.0 ppm; grass, 

forage, fodder and hay, group 17, hay 

and straw at 90.0 ppm; guava at 4.0 

ppm; hare’s ear mustard at 0.3 ppm; 

herbs and spices, subgroup 19A, dried 

at 90.0 ppm; herbs and spices, subgroup 

19A, fresh at 25.0 ppm; herbs and 

spices, subgroup 19B, spices at 7.0 ppm; 

hops at 90.0 ppm; horse, fat at 0.3 ppm; 

horse, liver at 0.3 ppm; horse, meat at 

0.05 ppm; horse, meat byproducts, 

except liver at 0.2 ppm; ilama at 4.0 

ppm; jaboticaba at 2.0 ppm; jojoba at 0.3 

ppm; lesquerella at 0.3 ppm; longan at 

4.0 ppm; lunaria at 0.3 ppm; lychee at 

2.0 ppm; mango at 4.0 ppm; milk at 0.05 

ppm; milkweed at 0.3 ppm; mint at 9.0 

ppm; mustard at 0.3 ppm; non-grass 

animal feeds, group 18, forage and 

fodder at 13.0 ppm; non-grass animal 

feeds, group 18, hay and straw at 45.0 

ppm; non-grass animal feeds, group 18, 

seeds at 3.5 ppm; nut, tree, group 14 at 

0.04 ppm; oil radish at 0.3 ppm; okra at 

0.7 ppm; olive at 4.0 ppm; olive, oil at 

40.0 ppm; papaya at 2.0 ppm; passion 

fruit at 2.0 ppm; peanut at 0.1 ppm; 

peanut hay at 90.0 ppm; persimmon at 

4.0 ppm; pineapple at 1.5 ppm; 

pineapple process residue at 3.0 ppm; 

pistachio at 0.04 ppm; pomegranate at 

4.0 ppm; poppy seed at 0.3 ppm; 

poultry, fat at 0.02 ppm; poultry, meat 

at 0.02 ppm; poultry, meat byproducts 

at 0.02 ppm; prickly pear cactus at 13.0 

ppm; pulasan at 4.0 ppm; raisins at 5.0 

ppm; rambutan at 4.0 ppm; rapeseed at 

0.3 ppm; rice, grain at 0.15 ppm; rice, 

hulls at 0.3 ppm; rice, straw at 0.3 ppm; 

rose hip at 0.3 ppm; sapodilla at 4.0 

ppm; sapote, mamey at 4.0 ppm; sesame 

at 0.3 ppm; sheep, fat at 0.3 ppm; sheep, 

liver at 0.3 ppm; sheep, meat at 0.05 

ppm; sheep, meat byproducts except 

liver at 0.2 ppm; soursop at 4.0 ppm; 

spanish lime at 4.0 ppm; star apple at 

4.0 ppm; starfruit at 4.0 ppm; 

strawberries at 1.0 ppm; sugar apple at 

4.0 ppm; sugarcane, cane at 14.0 ppm; 

sugarcane molasses at 420.0 ppm; 

tallowwood at 0.3 ppm; tea oil plant at 

0.3 ppm; ti palm, leaves at 13.0 ppm; ti 

palm, roots at 0.1 ppm; vegetables, 

brassica leafy, group 5 at 11.0 ppm; 

vegetables, foliage of legume, group 7, 

forage/vines at 30.0 ppm; vegetables, 

foliage of legume, group 7, hay at 90.0 

ppm; vegetables, legume, group 6, 

except soybeans at 2.0 ppm; vegetables, 

tuberous and corm, subgroup 1C at 0.01 

ppm; wax jambu at 4.0 ppm; white 

sapote (casimiroa) and other cultivars 

and/or hybrids at 4.0 ppm. that notice 

referenced a summary of the petition 

prepared by E.I. du Pont de Nemours 

and Company, Dupont Crop Protection, 

the registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

EPA has determined that tolerances 

are not required for several petitioned 

commodities. Additionally, the Agency 

is revising tolerances for several 

proposed individual and group 

commodities and is amending multiple 

established tolerances. Finally, EPA is 

deleting several existing tolerances. The 

details on the specific changes being 

made and the reasons for these changes 

are explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for 

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 teratogenic. Chlorantraniliprole has 

been found to have low acute toxicity by 

the oral, dermal, and inhalation routes 

of exposure and has little to no irritation 

effect on the eyes or skin. Additionally, 

chlorantraniliprole is not a dermal 

sensitizer. There was only one toxicity 

study in the toxicology database that 

indicated that Chlorantraniliprole 

yielded an adverse effect (18-month 

oral/mouse). This study was used to 

establish a point of departure based on 

hepatocellular effects for chronic risk. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by chlorantraniliprole as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document; 

‘‘Chlorantraniliprole (DPX-E2Y45). 

Human Health Risk Assessment for 

Section 3 Registration Request to 

Expand Uses of Coragen, Altacor, and 

Dermacor X-100 Labels on Various 

Field, Vegetable, and Fruit Crops,’’ page 

31 in docket ID number EPA–HQ–OPP– 

2009–0261. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a benchmark dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-term, intermediate-, and 

chronic-term risks are evaluated by 

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Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 5529 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the level of concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for chlorantraniliprole used 

for human risk assessment can be found 

at http://www.regulations.gov in the 

document; ‘‘Chlorantraniliprole (DPXE2Y45). Human Health Risk Assessment 

for Section 3 Registration Request to 

Expand Uses of Coragen, Altacor, and 

Dermacor X-100 Labels on Various 

Field, Vegetable, and Fruit Crops,’’ in 

docket ID number EPA–HQ–OPP–2009– 

0261. 

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 USDA 1994–1996 and 1998 

Continuing Survey of Food Intake by 

Individual (CSFII). As to residue levels 

in food, EPA assumed all foods for 

which there are tolerances were treated 

and contain tolerance-level residues. 

iii. Cancer. Chlorantraniliprole was 

classified as ‘‘Not likely to be 

Carcinogenic to Humans’’ based on 

evidence showing no treatment-related 

tumors in the submitted chronic and 

oncogenicity studies in rats and mice, 

and subchronic studies in mice, dogs, 

and rats, and no mutagenic concerns in 

the genotoxicity studies. Therefore, an 

exposure assessment to evaluate cancer 

risk is unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue 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 Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

chlorantraniliprole for chronic 

exposures for non-cancer assessments 

are estimated to be 3.65 ppb for surface 

water and 1.06 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 3.65 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 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: 

Turfgrass and ornamental plants. 

Residential exposure could occur for 

short-term and intermediate-term 

exposures 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. Additional 

information on residential exposure 

assumptions can be found at 

www.regulations.gov (Docket ID EPA– 

HQ–OPP–2009–0261, pages 24 through 

25). 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found chlorantraniliprole 

to share a common mechanism of 

toxicity with any other substances, and 

chlorantraniliprole does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that chlorantraniliprole does 

not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

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 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 

developmental or 2-generation 

reproduction studies. Additionally, 

there were no treatment related effects 

on the numbers of litters, fetuses (live or 

dead), resorptions, sex ratio, or 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 to reduced 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

chlorantraniliprole is complete and 

considered adequate for this risk 

assessment (including 40 CFR 158.500 

requirements for dermal toxicity, 

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immunotoxicity, and acute/subchronic 

neurotoxicity effective December 26, 

2007). 

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 food exposure 

assessment utilized tolerance-level 

residues and 100 PCT data. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

chlorantraniliprole in drinking water. 

Due to the lack of toxicity identified for 

short-term and intermediate-term 

durations via relevant routes of 

exposure, no risk is expected from 

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 pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute population adjusted dose 

(aPAD) and chronic population adjusted 

dose (cPAD). The aPAD and cPAD 

represent the highest safe exposures, 

taking into account all appropriate SFs. 

EPA calculates the aPAD and cPAD by 

dividing the POD by all applicable UFs. 

For linear cancer risks, EPA calculates 

the probability of additional cancer 

cases given the estimated aggregate 

exposure. Short-term, intermediateterm, and chronic-term risks are 

evaluated by comparing the estimated 

aggregate food, water, and residential 

exposure to the POD to ensure that the 

MOE called for by the product of all 

applicable UFs is not exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single-oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, chlorantraniliprole 

is not expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to 

chlorantraniliprole from food and water 

will utilize 5% of the cPAD for children 

1 to 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). 

Although short-term residential 

exposure could occur with the use of 

chlorantraniliprole, no toxicological 

effects resulting from short-term dosing 

were observed. Therefore, the aggregate 

risk is the sum of the risk from food and 

water and will not be greater than the 

chronic aggregate risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Although intermediate-term 

residential exposure could result from 

the use of chlorantraniliprole, no 

toxicological effects resulting from 

intermediate-term dosing were 

observed. Therefore, the aggregate risk is 

the sum of the risk from food and water 

and will not be greater than the chronic 

aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Based on evidence showing 

no treatment-related tumors in the 

submitted chronic and oncogenicity 

studies in rats and mice, and subchronic 

studies in mice, dogs, and rats, and no 

mutagenic concerns in the genotoxicity 

studies, chlorantraniliprole is not 

expected to pose a cancer risk to 

humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

chlorantraniliprole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

Liquid 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 

Regarding international Maximum 

Residue Levels (MRLs) for 

chlorantraniliprole, all tolerances are 

harmonized (tolerances and MRLs have 

equivalent residue levels and tolerance 

expressions) or U.S. tolerances are 

higher than Codex based on submitted 

data and differences in U.S. use 

patterns. U.S. tolerances exceed Codex 

MRLs for the following commodities: 

Grapes, edible offal (mammalian), milks, 

meat (from mammals), pome fruits, 

stone fruits and eggs. All other MRLs are 

harmonized with Codex. 

C. Response to Comments 

There were no comments received in 

response to the notice of filing. 

D. Revisions to Petitioned-For 

Tolerances 

EPA has revised the proposed 

tolerance levels of chlorantraniliprole 

on the following commodities: cacao 

bean from 0.15 ppm to 0.08 ppm; cacao 

bean, roasted bean from 1.4 ppm to 0.8 

ppm; cacao bean, chocolate from 3.0 

ppm to 1.5 ppm; cacao bean, cocoa 

powder from 3.0 ppm to 1.5 ppm; 

coffee, green bean from 0.5 ppm to 0.4 

ppm; coffee, instant from 2.5 ppm to 2.0 

ppm; egg from 0.1 ppm to 0.2 ppm; 

herbs and spices, subgroup 19B, spices 

from 7.0 ppm to 14 ppm; animal feed, 

nongrass, group 18, forage from 13.0 

ppm to 25 ppm; animal feed, nongrass, 

group 18, hay from 45 ppm to 90 ppm; 

alfalfa, seed from 3.5 ppm to 7.0 ppm; 

poultry, fat from 0.02 ppm to 0.01 ppm; 

rice, hulls from 0.3 ppm to 0.4 ppm. 

EPA revised the tolerance levels based 

on analysis of the residue field trial data 

using the Agency’s tolerance 

spreadsheet in accordance with the 

Agency’s Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data. 

The commodity, fruit, pome, group 11 

is being revised to read fruit, pome, 

group 11, except mayhaw. A separate 

tolerance of 0.6 ppm is being 

established for mayhaw. The 

commodity, fruit, stone, group 12 is 

being revised to read fruit, stone, group 

12, except cherry, chickasaw plum, and 

damson plum. Separate tolerances of 2.0 

ppm are being established for cherry, 

sweet; cherry, tart; plum, chickasaw; 

plum, damson. for these two groups the 

EPA has determined that for those 

commodities in these groups considered 

small fruit it is not approriatate to 

establish the higher tolerance because 

they have differing use directions with 

a longer phi that will result in lower 

residue levels. 

The petitioner requested tolerances on 

forage, fodder, and straw of cereal 

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grains, group 16, forage and fodder at 

25.0 ppm; and forage, fodder, and straw 

of cereal grains, group 16, hay and straw 

at 90.0 ppm. However, no tolerances 

were proposed for cereal grains, crop 

group 15. Without a tolerance for cereal 

grains, crop group 15, tolerances for 

cereal grains, crop group 16, forage, 

fodder and straw are not appropriate. 

However, based on submitted data and 

translation, the tolerance of 14 ppm can 

be established for the following 

individual crop group 16 commodities: 

corn, field, forage; corn, field, stover; 

corn, pop, forage; corn, pop, stover; 

corn, sweet, forage, and corn, sweet, 

stover. 

Based upon the re-examination of the 

available ruminant feeding study, EPA 

is establishing tolerance levels of 

chlorantraniliprole on the following 

commodities: Hog, fat at 0.02 ppm and 

hog, meat byproducts at 0.02 ppm. 

The current established tolerance of 

0.01 ppm for residues of 

chlorantraniliprole on potatoes is 

revoked upon the establishment of 

tolerances on vegetables, tuberous and 

corm, subgroup 1C at 0.01 ppm. The 

petitioner requested tolerances be 

established for fruit, small vine 

climbing, subgroup 13–07D at 2.5 ppm. 

The representative commodities for 

this subgroup are grape and fuzzy 

kiwifruit. Data are only available for 

grape. Therefore, the EPA is establishing 

a tolerance for fruit, small vine 

climbing, subgroup 13–07F at 2.5 ppm 

which is a subset of subgroup 13–07D. 

The current established tolerance of 1.2 

ppm for residues of chlorantraniliprole 

on grapes is revoked upon the 

establishment of tolerances on fruit, 

small vine climbing, subgroup 13–07F 

at 2.5 ppm. 

Finally, EPA has revised the tolerance 

expression to clarify (1) that, as 

provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of chlorantraniliprole not 

specifically mentioned; and (2) that 

compliance with the specified tolerance 

levels is to be determined by measuring 

only the specific compounds mentioned 

in the tolerance expression. 

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 acerola at 2.0 

ppm; animal feed, nongrass, group 18, 

forage at 25 ppm; animal feed, nongrass, 

group 18, hay at 90 ppm; alfalfa, seed 

at 7.0 ppm; artichoke, globe at 4.0 ppm; 

asparagus at 13 ppm; atemoya at 4.0 

ppm; avocado at 4.0 ppm; banana at 4.0 

ppm; biriba at 4.0 ppm; cacao bean at 

0.08 ppm; cacao bean, chocolate at 1.5 

ppm; cacao bean, cocoa powder at 1.5 

ppm; cacao bean, roasted bean at 0.8 

ppm; cactus at 13 ppm; canistel at 4.0 

ppm; cattle, liver at 0.3 ppm; cherimoya 

at 4.0 ppm; citrus, dried pulp at 14 ppm; 

coffee, green bean at 0.4 ppm; coffee, 

instant at 2.0 ppm; corn, sweet, kernel 

plus cobs with hush removed at 0.02 

ppm; corn, field, grain at 0.04 ppm; 

corn, field, milled byproducts at 0.1 

ppm; corn, pop, grain at 0.04 ppm; 

crambe, seed at 0.3 ppm; crayfish at 8.0 

ppm; custard apple at 4.0 ppm ; egg at 

0.2 ppm; feijoa at 4.0 ppm; fig at 4.0 

ppm; fruit, caneberry, subgroup 13-07A 

at 1.8 ppm; fruit, citrus, group 10 at 1.4 

ppm; fruit, small vine climbing, 

subgroup 13-07F at 2.5 ppm; goat, liver 

at 0.3 ppm; grass forage, fodder and hay, 

group 17 at 90 ppm; grain, aspirated 

fractions at 2.0 ppm; guava at 4.0 ppm; 

hare’s ear mustard, seed at 0.3 ppm; 

herb subgroup 19A, dried leaves at 90 

ppm; herb subgroup 19A, fresh leaves at 

25 ppm; hop, dried cones at 90 ppm; 

horse, liver at 0.3 ppm; ilama at 4.0 

ppm; jaboticaba at 2.0 ppm; jojoba, seed 

at 0.3 ppm; lesquerella, seed at 0.3 ppm; 

longan at 4.0 ppm; lunaria, seed at 0.3 

ppm; lychee at 2.0 ppm; mango at 4.0 

ppm; milkweed, seed at 0.3 ppm; 

mustard seed at 0.3 ppm; oil, radish, 

seed at 0.3 ppm; okra at 0.7 ppm; olive 

at 4.0 ppm; olive, oil at 40.0 ppm; 

papaya at 2.0 ppm; passionfruit at 2.0 

ppm; peppermint, tops at 9.0 ppm; 

persimmon at 4.0 ppm; pineapple at 1.5 

ppm; pineapple, process residue at 3.0 

ppm; pomegranate at 4.0 ppm; poppy, 

seed at 0.3 ppm; poultry, fat at 0.01 

ppm; poultry, meat byproducts at 0.02 

ppm; pulasan at 4.0 ppm; rambutan at 

4.0 ppm; rapeseed, seed at 0.3 ppm; 

rice, grain at 0.15 ppm; rice, hulls at 0.4 

ppm; rose hip, seed at 0.3 ppm; 

sapodilla at 4.0 ppm; sapote, black at 4.0 

ppm; sapote, mamey at 4.0 ppm; sapote, 

white at 4.0 ppm; sesame, seed at 0.3 

ppm; sheep, liver at 0.3 ppm; soursop at 

4.0 ppm; spanish lime at 4.0 ppm; 

spearmint, tops at 9.0 ppm; spice, 

subgroup 19B at 14 ppm; star apple at 

4.0 ppm; starfruit at 4.0 ppm; 

strawberries at 1.0 ppm; sugar apple at 

4.0 ppm; sugarcane, cane at 14 ppm; 

sugarcane, molasses at 420 ppm; 

tallowwood, seed at 0.3 ppm; tea oil 

plant, seed at 0.3 ppm; vegetables, 

foliage of legume, except soybean, 

subgroup 7A, forage at 30 ppm; 

vegetables, foliage of legume, except 

soybean, subgroup 7A, hay at 90 ppm; 

vegetables, legume, group 6, except 

soybeans at 2.0 ppm; vegetables, 

tuberous and corm, subgroup 1C at 0.01 

ppm; wax jambu at 4.0 ppm. 

Additionally, tolerances are amended 

for residues of chlorantraniliprole in or 

on apple, wet pomace from 0.60 ppm to 

2.5 ppm; cattle, fat from 0.01 ppm to 0.3 

ppm; cattle, meat from 0.01 ppm to 0.05 

ppm; cattle, meat byproducts from 0.01 

ppm to 0.2 ppm; fruit, pome, group 11, 

except mayhaw from 0.30 ppm to 1.2 

ppm; fruit, stone, group 12, except 

cherry, chickasaw plum, and damson 

plum from 0.30 ppm to 4.0 ppm; goat, 

fat from 0.01 ppm to 0.3 ppm; goat, meat 

from 0.01 ppm to 0.05 ppm; goat, meat 

byproduct from 0.01 ppm to 0.2 ppm; 

grape, raisin from 2.5 ppm to 5.0 ppm; 

horse, fat from 0.01 ppm to 0.3 ppm; 

horse, meat from 0.01 ppm to 0.05 ppm; 

horse, meat byproduct from 0.01 ppm to 

0.2 ppm; milk from 0.01 ppm to 0.05 

ppm; sheep, fat from 0.01 ppm to 0.3 

ppm; sheep, meat from 0.01 ppm to 0.05 

ppm; sheep, meat byproduct from 0.01 

ppm to 0.2 ppm. 

Although requests were made to 

amend residues of chlorantraniliprole in 

or on Crop Groups 11 and 12, the 

following individual commodities 

required separate tolerances. Tolerances 

are established for residues of 

chlorantraniliprole in or on cherry, 

sweet at 2.0 ppm; cherry, tart at 2.0 

ppm; mayhaw at 0.6 ppm; plum, 

chickasaw at 2.0 ppm and plum, 

damson at 2.0 ppm. 

In addition, requests were made to 

establish tolerances of 

chlorantraniliprole in or on Crop Group 

15, however adequate data were only 

submitted to support the establishment 

of tolerances for specific commodities. 

tolerances are established for residues of 

chlorantraniliprole in or on corn, field, 

forage at 14.0 ppm; corn, field, stover at 

14.0 ppm; corn, pop, forage at 14.0 ppm; 

corn, pop, stover at 14.0 ppm; corn, 

sweet, forage at 14.0 ppm and corn, 

sweet, stover at 14.0 ppm. 

This regulation deletes a tolerance in 

or on grape at 1.2 ppm and potato at 

0.01 ppm. Additionally, the following 

time-limited section 18 emergency 

exemption tolerances are deleted: corn, 

sweet, cannery waste at 6.0 ppm; corn, 

sweet, forage at 6.0 ppm; corn, sweet, 

kernel plus cob with husks removed at 

0.01 ppm; corn, sweet, stover at 6.0 

ppm; milk at 0.03 ppm; rice, grain at 

0.10 ppm and rice, straw at 0.25 ppm. 

Finally, this regulation deletes timelimited tolerances for indirect/ 

inadvertent residues of 

chlorantraniliprole in or on animal feed, 

nongrass, group 18 at 0.20 ppm; 

cowpea, forage at 0.20 ppm; cowpea, 

hay at 0.20 ppm; field pea, hay at 0.20 

ppm; field pea, vine at 0.20 ppm; grass, 

forage, fodder and hay, group 17 at 0.20 

ppm; okra at 0.70 ppm; strawberry at 

1.20 ppm and sugarcane at 0.20 ppm. 

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VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 26, 2010. 

Lois Rossi, 

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 revised to read 

as follows: 

§ 180.628 Chlorantraniliprole; tolerances 

for residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide chlorantraniliprole, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

chlorantraniliprole, 3-bromo-N-[4- 

chloro-2-methyl-6- 

[(methylamino)carbonyl]phenyl]-1-(3- 

chloro-2-pyridinyl)-1H-pyrazole-5- 

carboxamide. 

Commodity Parts per million 

Acerola ............................................................................................................................................................. 2.0 

Alfalfa, seed ..................................................................................................................................................... 7.0 

Almond, hulls ................................................................................................................................................... 5.0 

Animal feed, nongrass, group 18, forage ........................................................................................................ 25 

Animal feed, nongrass, group 18, hay 90 

Apple, wet pomace .......................................................................................................................................... 2.5 

Artichoke, globe ............................................................................................................................................... 4.0 

Asparagus ........................................................................................................................................................ 13 

Atemoya ........................................................................................................................................................... 4.0 

Avocado ........................................................................................................................................................... 4.0 

Banana ............................................................................................................................................................. 4.0 

Biriba ................................................................................................................................................................ 4.0 

Brassica, head and stem, subgroup 5A .......................................................................................................... 4.0 

Brassica, leafy greens, subgroup 5B .............................................................................................................. 11 

Cacao bean ..................................................................................................................................................... 0.08 

Cacao bean, chocolate .................................................................................................................................... 1.5 

Cacao bean, cocoa powder ............................................................................................................................. 1.5 

Cacao bean, roasted bean .............................................................................................................................. 0.8 

Cactus .............................................................................................................................................................. 13 

Canistel ............................................................................................................................................................ 4.0 

Cattle, fat ......................................................................................................................................................... 0.3 

Cattle, liver ....................................................................................................................................................... 0.3 

Cattle, meat ..................................................................................................................................................... 0.05 

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Commodity Parts per million 

Cattle, meat byproducts, except liver .............................................................................................................. 0.2 

Cherimoya ........................................................................................................................................................ 4.0 

Cherry, sweet ................................................................................................................................................... 2.0 

Cherry, tart ....................................................................................................................................................... 2.0 

Citrus, dried pulp ............................................................................................................................................. 14 

Coffee, green bean .......................................................................................................................................... 0.4 

Coffee, instant .................................................................................................................................................. 2.0 

Corn, field, forage ............................................................................................................................................ 14 

Corn, field, grain .............................................................................................................................................. 0.04 

Corn, field, milled byproducts .......................................................................................................................... 0.1 

Corn, field, stover ............................................................................................................................................ 14 

Corn, pop, forage ............................................................................................................................................. 14 

Corn, pop, grain ............................................................................................................................................... 0.04 

Corn, pop, stover ............................................................................................................................................. 14 

Corn, sweet, forage ......................................................................................................................................... 14 

Corn, sweet, kernel plus cobs with husk removed ......................................................................................... 0.02 

Corn, sweet, stover .......................................................................................................................................... 14 

Cotton, gin byproduct ...................................................................................................................................... 30 

Cotton, hulls ..................................................................................................................................................... 0.40 

Cotton, undelinted seed ................................................................................................................................... 0.30 

Crambe, seed .................................................................................................................................................. 0.3 

Crayfish ............................................................................................................................................................ 8.0 

Custard apple .................................................................................................................................................. 4.0 

Egg ................................................................................................................................................................... 0.2 

Feijoa ............................................................................................................................................................... 4.0 

Fig .................................................................................................................................................................... 4.0 

Fruit, caneberry, subgroup 13–07A ................................................................................................................. 1.8 

Fruit, citrus, group 10 ...................................................................................................................................... 1.4 

Fruit, pome, group 11, except mayhaw ........................................................................................................... 1.2 

Fruit, small vine climbing, subgroup 13–07F .................................................................................................. 2.5 

Fruit, stone, group 12, except cherry, chickasaw plum, and damson plum ................................................... 4.0 

Goat, fat ........................................................................................................................................................... 0.3 

Goat, liver ........................................................................................................................................................ 0.3 

Goat, meat ....................................................................................................................................................... 0.05 

Goat, meat byproducts, except liver ................................................................................................................ 0.2 

Grain, aspirated fractions ................................................................................................................................ 2.0 

Grape, raisin .................................................................................................................................................... 5.0 

Grass forage, fodder and hay, group 17 ......................................................................................................... 90 

Guava .............................................................................................................................................................. 4.0 

Hare’s ear mustard, seed ................................................................................................................................ 0.3 

Herb subgroup 19A, dried leaves .................................................................................................................... 90 

Herb subgroup 19A, fresh leaves .................................................................................................................... 25 

Hog, fat ............................................................................................................................................................ 0.02 

Hog, meat byproducts ..................................................................................................................................... 0.02 

Hop, dried cones ............................................................................................................................................. 90 

Horse, fat ......................................................................................................................................................... 0.3 

Horse, liver ....................................................................................................................................................... 0.3 

Horse, meat ..................................................................................................................................................... 0.05 

Horse, meat byproducts, except liver .............................................................................................................. 0.2 

Ilama ................................................................................................................................................................ 4.0 

Jaboticaba ........................................................................................................................................................ 2.0 

Jojoba, seed .................................................................................................................................................... 0.3 

Lesquerella, seed ............................................................................................................................................ 0.3 

Longan ............................................................................................................................................................. 4.0 

Lunaria, seed ................................................................................................................................................... 0.3 

Lychee ............................................................................................................................................................. 2.0 

Mango .............................................................................................................................................................. 4.0 

Mayhaw ............................................................................................................................................................ 0.6 

Milk ................................................................................................................................................................... 0.05 

Milkweed, seed ................................................................................................................................................ 0.3 

Mustard, seed .................................................................................................................................................. 0.3 

Nut, tree, group 14 .......................................................................................................................................... 0.04 

Oil, radish, seed ............................................................................................................................................... 0.3 

Okra ................................................................................................................................................................. 0.7 

Olive ................................................................................................................................................................. 4.0 

Olive, oil ........................................................................................................................................................... 40 

Papaya ............................................................................................................................................................. 2.0 

Passionfruit ...................................................................................................................................................... 2.0 

Peppermint, tops .............................................................................................................................................. 9.0 

Persimmon ....................................................................................................................................................... 4.0 

Pineapple ......................................................................................................................................................... 1.5 

Pineapple, process residue ............................................................................................................................. 3.0 

Pistachio .......................................................................................................................................................... 0.04 

Plum, chickasaw .............................................................................................................................................. 2.0 

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5534 Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 

Commodity Parts per million 

Plum, damson .................................................................................................................................................. 2.0 

Pomegranate ................................................................................................................................................... 4.0 

Poppy, seed ..................................................................................................................................................... 0.3 

Poultry, fat ........................................................................................................................................................ 0.01 

Poultry, meat byproducts ................................................................................................................................. 0.02 

Pulasan ............................................................................................................................................................ 4.0 

Rambutan ........................................................................................................................................................ 4.0 

Rapeseed, seed ............................................................................................................................................... 0.3 

Rice, grain ........................................................................................................................................................ 0.15 

Rice, hulls ........................................................................................................................................................ 0.4 

Rose hip, seed ................................................................................................................................................. 0.3 

Sapodilla .......................................................................................................................................................... 4.0 

Sapote, black ................................................................................................................................................... 4.0 

Sapote, mamey ................................................................................................................................................ 4.0 

Sapote, white ................................................................................................................................................... 4.0 

Sesame, seed .................................................................................................................................................. 0.3 

Sheep, fat ........................................................................................................................................................ 0.3 

Sheep, liver ...................................................................................................................................................... 0.3 

Sheep, meat .................................................................................................................................................... 0.05 

Sheep, meat byproducts, except liver ............................................................................................................. 0.2 

Soursop ............................................................................................................................................................ 4.0 

Spanish lime .................................................................................................................................................... 4.0 

Spearmint, tops ................................................................................................................................................ 9.0 

Spice, subgroup 19B ....................................................................................................................................... 14 

Star apple ........................................................................................................................................................ 4.0 

Starfruit ............................................................................................................................................................ 4.0 

Strawberry ........................................................................................................................................................ 1.0 

Sugar apple ..................................................................................................................................................... 4.0 

Sugarcane, cane .............................................................................................................................................. 14 

Sugarcane, molasses ...................................................................................................................................... 420 

Tallowwood, seed ............................................................................................................................................ 0.3 

Tea oil plant, seed ........................................................................................................................................... 0.3 

Vegetable, cucurbit, group 9 ........................................................................................................................... 0.25 

Vegetable, foliage of legume, except soybean, subgroup 7A, forage ............................................................ 30

Vegetable, foliage of legume, except soybean, subgroup 7A, hay ................................................................ 90 

Vegetable, fruiting, group 8 ............................................................................................................................. 0.70 

Vegetable, leafy, except brassica, group 4 ..................................................................................................... 13 

Vegetable, legume, group 6, except soybeans ............................................................................................... 2.0 

Vegetable, tuberous and corm, subgroup 1C ................................................................................................. 0.01 

Wax jambu ....................................................................................................................................................... 4.0 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

Time-limited tolerances are established 

for the indirect or inadvertent residues 

of the insecticide chlorantraniliprole, 

including its metabolites and 

degradates, in or on the commodities in 

the table below when present therein as 

a result of the application of 

chlorantraniliprole to the growing crops 

listed in paragraph (a) of this section. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only chlorantraniliprole, 3- 

bromo-N-[4-chloro-2-methyl-6- 

[(methylamino)carbonyl]phenyl]-1-(3- 

chloro-2-pyridinyl)-1H-pyrazole-5- 

carboxamide. 

Commodity Parts per million Expiration/revocation date 

Grain, cereal, forage, fodder and straw, group 16 .......................... 0.20 04/10/10 

Leek ................................................................................................. 0.20 04/10/10 

Onion, green .................................................................................... 0.20 04/10/10 

Onion, welsh .................................................................................... 0.20 04/10/10 

Peanut, hay ...................................................................................... 0.20 04/10/10 

Shallot .............................................................................................. 0.20 04/10/10 

Soybean, forage .............................................................................. 0.20 04/10/10 

Soybean, hay ................................................................................... 0.20 04/10/10 

Vegetable, leaves of root and tuber, group 2 ................................. 0.20 04/10/10 

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Federal Register / Vol. 75, No. 22 / Wednesday, February 3, 2010 / Rules and Regulations 5535 

[FR Doc. 2010–2254 Filed 2–2–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF TRANSPORTATION 

Office of the Secretary 

49 CFR Part 26 

[Docket No. OST–2010–0021] 

RIN 2105–AD76 

Participation by Disadvantaged 

Business Enterprises in Department of 

Transportation Financial Assistance 

Programs 

AGENCY: Office of the Secretary (OST), 

DOT. 

ACTION: Final rule. 

SUMMARY: This final rule changes the 

Department of Transportation 

(Department) regulation concerning how 

often recipients of DOT financial 

assistance are required to submit to the 

appropriate DOT operating 

administration for approval the 

methodology and process used to 

establish their overall disadvantaged 

business enterprise (DBE) goal for 

federally funded contracting 

opportunities. Under the rule, recipients 

will submit overall goals for review 

every three years, rather than annually. 

DATES: Effective Date: This rule is 

effective March 5, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Robert C. Ashby, Deputy Assistant 

General Counsel for Regulation and 

Enforcement, U.S. Department of 

Transportation, 1200 New Jersey 

Avenue, SE., Room W94–302, 

Washington, DC 20590, 202 366–9310, 

Bob.Ashby@dot.gov. 

SUPPLEMENTARY INFORMATION: On April 

8, 2009, the Department published in 

the Federal Register at 74 FR 15910, a 

notice of proposed rulemaking (NPRM) 

inviting public comment on a proposal 

to establish a staggered three-year 

schedule for the submission by DOT 

recipients subject to the regulations at 

49 CFR part 26 of their overall goal for 

DBE participation on DOT-assisted 

contracts. Recipients are currently 

required to make a DBE goal submission 

each year on August 1st. This proposed 

rule change was modeled largely on the 

comparable provision in the airport 

concessions DBE rule in Part 23 of this 

Title, with which the Department has 

had successful experience. 

The Department received 

approximately 27 comments from state 

departments of transportation, airports, 

transit authorities, DBEs, contractor 

associations, and transportation 

consultants. This final rule responds to 

the substantive concerns raised in the 

comments from those who supported or 

opposed the adoption of the proposed 

rule. 

The majority of commenters 

supported the proposed rule change as 

long as recipients are either required to 

conduct annual reviews to account for 

changes that may warrant a 

modification of the overall goal or are 

simply allowed to make adjustments to 

the overall goal during the three-year 

period based on changed circumstances 

without necessarily requiring annual 

reviews. Some of the circumstances or 

conditions that may indicate the need 

for an adjustment include, but are not 

limited to, the collection of new data, a 

significant change in the recipient’s 

DOT assisted contracting program (e.g., 

new contracting opportunities presented 

by the availability of new or different 

grant opportunities), a marked increase 

or decrease in the availability of DBEs 

in the recipient’s contracting market, or 

a significant change in the legal 

standards governing the DBE program. 

Some supporters also thought it 

advisable to give recipients the 

flexibility to request a waiver to set their 

own schedule or to submit an overall 

goal that covers a one-, two-, or threeyear period as appropriate due to the 

nature of the recipient’s contracting 

program. The ability to maintain the 

status quo—i.e., set annual overall 

goals—was an approach strongly 

endorsed by some airports, some 

representatives of the aviation industry, 

and some representatives of general 

contractors. 

The commenters opposed to the 

proposed rule change raised several 

concerns about moving to a three-year 

cycle: (1) The difficulty in estimating a 

DBE goal beyond one year given the 

changes in the political landscape or 

changes in the kind of projects that are 

funded; (2) locking in goals for three 

years undermines the ability to assess 

market conditions and DBE availability; 

(3) requiring annual reviews during the 

three-year period defeats the purpose of 

reducing the administrative burden 

associated with the annual goal setting 

process since an annual review will 

likely result in the need for an 

adjustment and thereby trigger the 

annual goal setting process; and (4) it 

fails to achieve a level playing field or 

ensure narrow tailoring. 

Having considered the comments, the 

Department believes going to a system 

of staggered three-year overall DBE goal 

submissions would not compromise the 

ability of recipients to implement a 

narrowly tailored program and would 

enable recipients to improve the data 

collection, analysis, and consultation 

required to establish an overall goal that 

truly aims to reflect the level of DBE 

participation one would expect absent 

the effects of discrimination. Since the 

DBE program rules were substantially 

revised in 1999, generally we have not 

seen huge variances in the annual DBE 

goal submissions made by recipients 

over the last ten years. Thus, we do not 

assume that requiring an annual review 

would necessarily lead to annual 

adjustments resulting from a process 

that mimics the current yearly process. 

That said, we do not think it necessary 

to mandate annual reviews. Instead, we 

believe recipients or operating 

administrations should be allowed, 

based on changed circumstances, to 

initiate mid-course reviews as needed to 

determine if adjustments to the overall 

goal are warranted. Also, we do not 

think it prudent to allow each recipient 

to establish a different schedule for 

submission. Such a series of exceptions 

would likely swallow the rule. It also 

would make it much more difficult for 

operating administrations to manage 

reviews and oversee compliance. 

However, in those cases where a 

recipient believes its situation differs 

from other similarly situated recipients, 

the existing program waiver process 

offers the recipient the opportunity to 

seek an exception. These program 

waivers, unlike the general program 

waiver provisions of 49 CFR 26.15, 

could be granted by an operating 

administration and would not have to 

be approved by the Secretary. 

Under the final rule, each operating 

administration is required to establish a 

schedule for submissions to be posted 

on its Web site. The schedules are 

intended to be posted no later than 30 

days after the effective date of this rule. 

During the transition to this new 

system, specific notice of the deadline 

for overall goal submissions and the 

consequences of failing to meet the 

deadline should be provided to 

recipients. The schedules established by 

the operating administrations should 

include each year a proportionate or 

representative number of recipients 

from all regions of the country (e.g., 

north, south, east, and west). During the 

transition to the new scheduling system, 

recipients should continuing using or 

operating under the goals last approved 

by the operating administration. 

Regulatory Analyses and Notices 

Executive Order 12866 and Regulatory 

Flexibility Act 

The Department has determined that 

this action is not a significant regulatory 

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