Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Rules and Regulations 44815 

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) (Pub. L. 

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). 

VIII. 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: July 12, 2011. 

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. In § 180.920, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.920. Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Carboxymethyl guar gum sodium salt (CAS Reg. No. 39346–76–4) .............. Without limitation ................ Thicker/drift reduction agent. 

*******

Carboxymethyl-hydroxypropyl guar (CAS Reg. No. 68130–15–4) .................. Without limitation ................ Thicker/drift reduction agent. 

*******

[FR Doc. 2011–18588 Filed 7–26–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0888; FRL–8875–5] 

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. This 

regulation additionally amends 

previously established tolerances in or 

on multiple commodities and deletes 

tolerances in or on several commodities 

that will be superceded by inclusion in 

crop group tolerances. 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 July 

27, 2011. Objections and requests for 

hearings must be received on or before 

September 26, 2011, 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–2010–0888. 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, 

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44816 Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Rules and Regulations 

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: Rita 

Kumar, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8291; e-mail address: 

kumar.rita@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 

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–2010–0888 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 September 26, 2011. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0888, 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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of February 

25, 2011 (76 FR 10584) (FRL–8863–3), 

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 0F7763) by, E. I. 

du Pont de Nemours and Company, 

DuPont Crop Protection, 1700 Market 

St., 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 bushberry, 

subgroup 13–07B at 2.5 parts per 

million (ppm); large shrub/tree berry, 

subgroup 13–07C at 2.5 ppm; low 

growing berry, subgroup 13–07G at 2.5 

ppm; ti palm, roots at 0.35 ppm; ti palm, 

leaves at 13 ppm; root and tuber 

vegetables, group 1 at 0.35 ppm; leaves 

of root and tuber vegetables, group 2 at 

40 ppm; sugar beet molasses at 11 ppm; 

onion, bulb, subgroup 3–07A at 0.35 

ppm; peanut, nutmeat at 0.35 ppm; 

peanut, hay at 90 ppm; tea, dried leaves 

at 50 ppm; and to increase tolerances in 

or on fruiting vegetables (except 

cucurbits), group 8 from 0.7 ppm to 0.90 

ppm; cucurbit vegetables, group 9 from 

0.25 ppm to 0.30 ppm; and okra from 

0.70 ppm to 0.90 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 in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the tolerances for some of the petitioned 

commodities. Additionally, the Agency 

is revising tolerances for several 

proposed individual and group 

commodities and is revoking multiple 

established tolerances. The reason 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 

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Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Rules and Regulations 44817 

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. 

Sufficient toxicology information 

exists for chlorantraniliprole for 

selecting doses and endpoints needed 

for assessing its risk to humans when 

used as an insecticide. 

Chlorantraniliprole is not genotoxic, 

neurotoxic, immunotoxic, carcinogenic, 

or developmentally toxic. 

Chlorantraniliprole is not acutely toxic 

via oral, dermal or inhalation routes of 

exposure. Neither is chlorantraniliprole 

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 

exposure. This study was used to 

establish a point of departure (POD), 

based on hepatocellular effects, for the 

chronic dietary exposure scenario. 

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 

‘‘Human Health Risk Assessment for 

Proposed Label Amendments to Remove 

Adjuvant Restrictions with Concomitant 

Increase in Tolerance for Fruiting and 

Leafy Vegetables and to Add Oilseed 

Rotational Crops,’’ at page 22 in docket 

ID number EPA–HQ–OPP–2010–0888. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern (LOC) to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD) and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for chlorantraniliprole used 

for human risk assessment is shown in 

the following Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CHLORANTRANILIPROLE FOR USE IN HUMAN HEALTH

RISK ASSESSMENT

Exposure/Scenario Point of departure and 

uncertainty/Safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary (All populations) ....... Not Applicable (N/A) ..................... N/A ................................................ No acute hazard attributable to a 

single dose was identified; 

therefore, an acute dietary endpoint was not selected for 

quantitative risk assessment. 

Chronic dietary (All populations) .... NOAEL = 158 milligrams/kilogram/day (mg/kg/day).

UFA = 10x 

UFH = 10 x 

FQPA SF = 1x 

Chronic RfD = 1.58 mg/kg/day 

cPAD = 1.58 mg/kg/day 

18-Month Oral (feeding)/mouse 

LOAEL = 935 mg/kg/day based 

on eosinophilic foci accompanied by hepatocellular hypertrophy and increased liver 

weight (males only). 

Incidental oral short/intermediateterm (1 to 30 days).N/A ................................................ N/A ................................................ There was no hazard identified 

via the oral route over the 

short- and intermediate-term 

and therefore, no endpoint was 

selected for quantitative risk assessment. 

Dermal short/intermediate-term ..... N/A ................................................ N/A ................................................ There was no hazard identified 

via the dermal route (and no 

concerns for developmental, reproductive or neurotoxic effects) 

and therefore, no dermal endpoint was selected for quantitative risk assessment. 

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44818 Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Rules and Regulations 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CHLORANTRANILIPROLE FOR USE IN HUMAN HEALTH

RISK ASSESSMENT—Continued 

Exposure/Scenario Point of departure and 

uncertainty/Safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Inhalation short/intermediate-term N/A ................................................ N/A ................................................ Based on the lack of hazard identified in the acute inhalation 

study, lack of acute irritation, 

and extremely low oral toxicity—no inhalation endpoint 

was selected for quantitative 

risk assessment. 

Cancer (Oral, dermal, inhalation) .. Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on weight of evidence of data: no treatment-related tumors reported in the submitted chronic and oncogenicity studies in rats and mice, subchronic studies in mice, dogs and rats and that no mutagenic concern was reported in the genotoxicity 

studies. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account 

for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population-adjusted dose (a= 

acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of corcern. 

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 recommended 

and/or established tolerance level 

residues and 100 percent crop treated 

(PCT). 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 PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for chlorantraniliprole. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for chlorantraniliprole in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of chlorantraniliprole. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the 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 acute 

and chronic estimated drinking water 

concentrations (EDWCs) of 

chlorantraniliprole were 55.30 parts per 

billion (ppb) and 39.87 ppb, 

respectively. 

The surface water concentration of 

39.87 ppb was used for chronic 

exposure for the chronic, non-cancer 

dietary risk assessment. 

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: 

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 http// 

www.regulations.gov (Docket ID EPA– 

HQ–OPP–2010—0888, ‘‘Human Health 

Risk Assessment for Proposed Label 

Amendments to Remove Adjuvant 

Restrictions with Concomitant Increase 

in Tolerance for Fruiting and Leafy 

Vegetables and to Add Oilseed 

Rotational crops ’’, page 37). 

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 

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Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Rules and Regulations 44819 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA 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 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 post-implantation loss and no 

effects on fetal body weights, skeletal 

ossification, and external, visceral, or 

skeletal malformations or variations. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

chlorantraniliprole is complete, and 

considered adequate for this risk 

assessment (including 40 CFR 158.500 

requirements for dermal toxicity, 

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 dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground water and surface water 

modeling used to assess exposure to 

chlorantraniliprole in drinking water. 

Due to the lack of toxicity via the 

dermal route, as well as the lack of 

toxicity over the acute-, short- and 

intermediate-term via the oral route—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 dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the aPAD and 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). 

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 the lack of 

evidence of carcinogenicity in two 

rodent carcinogenicity 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 

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 U.N. 

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 and Canada have 

established maximum residue levels 

(MRLs) for chlorantraniliprole in or on 

a number of crops and animal 

commodities. These MRLs are different 

than the tolerances established for 

chlorantraniliprole in the United States. 

There are no Mexican MRLs for 

chlorantraniliprole as Mexico adopts 

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44820 Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Rules and Regulations 

Codex or US standards for its export 

purposes. Refer to the International 

Residue Limit Status appended at the 

end of the document ‘‘Human Health 

Risk Assessment for Proposed Label 

Amendments to Remove Adjuvant 

Restrictions with Concomitant Increase 

in Tolerance for Fruiting and Leafy 

Vegetables and to Add Oilseed 

Rotational Crops,’’ pages 52–53, and an 

addendum to this risk assessment, at 

http://www.regulations.gov (Docket ID 

EPA–HQ–OPP–2010–0888). 

Although the tolerance expression 

achieved harmonization, harmonized 

MRLs were only achieved for a few 

commodities. This is the result of 

differences in crop grouping and 

removing the adjuvant restriction in the 

United States. To allow for the use of 

adjuvant in the United States it was 

necessary to adjust the tolerances by a 

factor of two for some crop groups after 

reviewing bridging residue data. This 

causes disharmony with Codex MRLs 

for berries, curcubits, fruiting vegetable, 

root and tuber vegetables, and leaves of 

root and tuber vegetables; and with 

Canada MRLs for curcubit vegetables 

and fruiting vegetables. 

C. Response to Comments 

There were no comments received in 

response to the notice of filing. 

D. Revisions to Petitioned-For 

Tolerances 

Based on residue data submitted with 

this petition, several petitioned-for 

tolerances were revised. The revisions 

include: increases for fruiting vegetables 

except cucurbits from 0.9 to 1.4 ppm, 

and cucurbits from 0.3 to 0.5 ppm; 

decreases in low growing berries from 

2.5 to 1.0 ppm, onions, bulb from 0.35 

to 0.30 ppm, beet, sugar, molasses from 

11 to 9 ppm, Ti, root from 0.35 to 0.30 

ppm, and root and tuber vegetables from 

0.35 to 0.30 ppm. 

Tolerances for okra, strawberry, and 

vegetables, tuberous and corm, 

subgroup 1C were deleted as these 

commodities are now covered by 

fruiting vegetables crop group 8–10, 

berry, low-growing subgroup 13–07G, 

and vegetable, root and tuber, group 1, 

respectively. 

The proposed tolerances for peanut 

hay and peanut nutmeat are not being 

established at this time. More residue 

data are needed. 

In § 180.628(d), the tolerance for 

vegetables, leaves of root and tuber, 

group 2 was replaced by the tolerance 

for this crop group in § 180.628(a). The 

tolerance for shallot, fresh leaves was 

added to § 180.628(d). 

V. Conclusion 

Therefore, tolerances are established 

for residues of chlorantraniliprole, 

including its metabolites and 

degradates, in or on the commodities 

listed in § 180.368. 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. 3-bromo-N-[4-chloro-2- 

methyl-6- 

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

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

carboxamide. Tolerances are established 

in or on the following commodities: 

Bushberry, subgroup 13–07B at 2.5 

ppm; Vegetable, cucurbit, group 9 at 0.5 

ppm; vegetable fruiting, group 8–10 at 

1.4 ppm; Berry, large shrub/tree, 

subgroup 13–07C at 2.5 ppm; Vegetable, 

leaves of root and tuber, group 2 at 40 

ppm; Berry, low growing subgroup 13– 

07G at 1.0 ppm; Onion, bulb, subgroup 

3–07A at 0.30 ppm; Vegetable, root and 

tuber, group 1 at 0.30 ppm; Beet, sugar, 

molasses at 9 ppm; Tea, dried at 50 

ppm; Ti, leaves, at 13 ppm; and Ti, root, 

at 0.30 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) (Pub. L. 

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. 

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Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Rules and Regulations 44821 

Dated: July 12, 2011. 

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 amended as 

follows: 

■ i. Add alphabetically tolerances for 

beet, sugar, molasses; berry large shrub/ 

tree, subgroup 13–07C; berry, low 

growing, subgroup at 13–07G; onion, 

bulb, subgroup 3–07A; tea, dried; Ti, 

leaves; Ti, root; vegetable, leaves of root 

and tuber, group 2; vegetable, root and 

tuber, group 1; to the table in paragraph 

(a); 

■ ii. Revise the tolerances for vegetable, 

cucurbit, group 9; and vegetable, 

fruiting, group 8–10 in the table to 

paragraph (a); 

■ iii. Remove the entries for okra, 

strawberry, and vegetable, tuberous and 

corm, subgroup 1C from the table in 

paragraph (a); 

■ iv. Remove the entries for shallot and 

vegetables, leaves of root and tuber, 

group 2 from paragraph (d); and 

■ v. Add alphabetically an entry for 

shallot, green leaves to the table in 

paragraph (d). 

The added and revised text read as 

follows: 

§ 180.628 Chlorantraniliprole; tolerances 

for residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Beet, sugar, molasses .................. 9 .0 

Berry, large shrub/tree, subgroup 

13–07C ...................................... 2 .5 

Berry, low growing, subgroup 13– 

07G ........................................... 1 .0 

* * * * * 

Onion, bulb, subgroup 3–07A ...... 0 .30 

* * * * * 

Tea, dried ..................................... 50 .0 

* * * * * 

Ti, leaves ...................................... 13 .0 

Ti, root .......................................... 0 .3 

* * * * * 

Vegetable, cucurbit, group 9 ........ 0 .5 

* * * * * 

Vegetable, fruiting, group 8–10 .... 1 .4 

Commodity Parts per 

million 

* * * * * 

Vegetable, leaves of root and 

tuber, group 2 ........................... 40 .0 

* * * * * 

Vegetable, root and tuber, group 

1 ................................................ 0 .30 

* * * * * 

* * * * * 

(d) * * * 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

* * * * * 

Shallots, fresh 

leaves ........ 0.20 04/10/14 

* * * * * 

[FR Doc. 2011–18708 Filed 7–26–11; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 73 and 74 

[MB Docket No. 03–185; FCC 11–110] 

Digital Low Power Television, 

Television Translator, and Television 

Booster Stations and To Amend Rules 

for Digital Class A Television Stations 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In the Second Report and 

Order, the Commission takes steps to 

resolve the remaining issues in this 

proceeding in order to allow a timely 

and successful completion of the low 

power television digital transition. 

Although Congress established a hard 

deadline of June 12, 2009 for full power 

stations to cease analog operations and 

begin operating only in digital, the 

statutory deadline did not apply to low 

power television stations. Therefore, 

while all full power television stations 

have ceased over-the-air analog 

broadcasting, many low power 

television stations are continuing to 

transmit analog signals. 

DATES: Effective August 26, 2011, except 

for the amendment to 47 CFR 73.624(g), 

which contains information collection 

requirements that have not been 

approved by the Office of Management 

and Budget (‘‘OMB’’). The Federal 

Communications Commission will 

publish a separate document in the 

Federal Register announcing the 

effective date. 

FOR FURTHER INFORMATION CONTACT: 

Shaun Maher, Shan.Maher@fcc.gov of 

the Media Bureau, Video Division, (202) 

418–1600. For additional information 

concerning the information collection 

requirement contained in this Second 

Report and Order, contact the Office of 

Managing Director (‘‘OMD’’), 

Performance Evaluation & Records 

Management (‘‘PERM’’), Cathy 

Williams, Cathy.Williams@fcc.gov, at 

202–418–2918. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Second 

Report and Order, FCC 11–110, adopted 

on July 15, 2011, and released on July 

15, 2011. The full text of the Second 

Report and Order is available for 

inspection and copying during regular 

business hours in the FCC Reference 

Center, 445 Twelfth Street, SW., Room 

CY–A257, Portals II, Washington, DC 

20554, and may also be purchased from 

the Commission’s copy contractor, 

BCPI, Inc., Portals II, 445 Twelfth Street, 

SW., Room CY–B402, Washington, DC 

20554. Customers may contact BCPI, 

Inc. via their Web site, http:// 

www.bcpi.com, or call 1–800–378–3160. 

This document is available in 

alternative formats (computer diskette, 

large print, audio record, and Braille). 

Persons with disabilities who need 

documents in these formats may contact 

the FCC by e-mail: FCC504@fcc.gov or 

phone: 202–418–0530 or TTY: 202–418– 

0432. 

Executive Summary 

In the Second Report and Order, the 

Commission takes steps to resolve the 

remaining issues in this proceeding in 

order to allow a timely and successful 

completion of the low power television 

digital transition. Specifically, in order 

to ensure a timely and successful 

completion to the low power television 

digital transition, the Commission takes 

the following steps: (1) Adopts a hard 

deadline of September 1, 2015 for the 

termination of all analog low power 

television facilities; (2) establishes rules 

permitting those stations needing 

additional time to complete their digital 

transition to obtain a ‘‘last minute’’ 

extension; (3) requires existing analog 

and digital low power television 

stations in the 700 MHz band (channels 

52–69) to submit displacement 

applications by September 1, 2011, and 

to cease operations in the 700 MHz band 

by December 31, 2011; (4) increases the 

power limits for VHF low power 

television channels to 3 kilowatts (the 

current analog power limit); (5) 

delegates to the Media Bureau the 

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