30470 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Rules and Regulations 

TABLE 2—BREAKPOINTS FOR THE AQI 

These breakpoints Equal these AQI’s 

O3 (ppm) 

8-hour 

O3 (ppm) 

1-hour 1

PM2.5

(μg/m3) 

PM10

(μg/m3) CO (ppm) SO2 (ppm) NO2(ppm) AQI Category 

0.000–0.059 ................ .................... 0.0–15.4 0–54 0.0–4.4 0.000–0.034 (3) 0–50 Good. 

0.060–0.075 ................ .................... 15.5–40.4 55–154 4.5–9.4 0.035–0.144 (3) 51–100 Moderate. 

0.076–0.095 ................ 0.125–0.164 40.5–65.4 155–254 9.5–12.4 0.145–0.224 (3) 101–150 Unhealthy for Sensitive Groups. 

0.096–0.115 ................ 0.165–0.204 4 65.5–150.4 255–354 12.5–15.4 0.225–0.304 (3) 151–200 Unhealthy. 

0.116–0.374 ................ 0.205–0.404 4 150.5–250.4 355–424 15.5–30.4 0.305–0.604 0.65–1.24 201–300 Very Unhealthy. 

(2) ................................ 0.405–0.504 4 250.5–350.4 425–504 30.5–40.4 0.605–0.804 1.25–1.64 301–400 

(2) ................................ 0.505–0.604 4 350.5–500.4 505–604 40.5–50.4 0.805–1.004 1.65–2.04 401–500 Hazardous. 

1Areas are generally required to report the AQI based on 8-hour ozone values. However, there are a small number of areas where an AQI 

based on 1-hour ozone values would be more precautionary. In these cases, in addition to calculating the 8-hour ozone index value, the 1-hour 

ozone index value may be calculated, and the maximum of the two values reported. 2 8-hour O3 values do not define higher AQI values (≥ 301). AQI values of 301 or greater are calculated with 1-hour O3 concentrations. 3 NO2 has no short-term NAAQS, and can generate an AQI only above the value of 200. 4 If a different SHL for PM2.5 is promulgated, these numbers will change accordingly. 

* * * * * 

[FR Doc. E9–15326 Filed 6–25–09; 8:45 am] 

BILLING CODE 1505–01–D 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0770; FRL–8413–6] 

Chlorantraniliprole; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

chlorantraniliprole in or on almonds; 

nut, tree, crop group 14, and pistachios. 

E.I. Du Pont de Nemours and Company 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). This regulation also 

establishes time-limited rotational crop 

tolerances for residues of 

chlorantraniliprole in or on cowpeas, 

forage and hay; field peas, vines and 

hay; forage, fodder and straw of cereal 

grains, crop group 16; grass forage, 

fodder and hay, crop group 17; leaves of 

root and tuber vegetables, crop group 2, 

leeks, nongrass animal feeds (forage, 

fodder, straw and hay), crop group 18; 

okra; onions, green; onions, Welsh; 

peanuts, hay; shallots; soybeans, forage 

and hay; strawberries and sugarcane, 

sugar. The time-limited tolerances 

expire on April 25, 2010. 

DATES: This regulation is effective June 

26, 2009. Objections and requests for 

hearings must be received on or before 

August 25, 2009, 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–2008–0770. 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.kable@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also 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 

Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Rules and Regulations 30471 

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–2008–0770 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 August 25, 2009. 

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–2008–0770, 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 and Notice of 

Proposed Rulemaking 

In the Federal Register of December 3, 

2008 (73 FR 73640) (FRL–8390–4), 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 8F7409) 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)-1 H-pyrazole-5-carboxamide, 

in or on almond hulls at 5.0 parts per 

million (ppm), nut, tree, crop group 14 

at 0.07 ppm and pistachios at 0.07 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. 

Based upon review of the data 

supporting the petition, EPA has 

reduced the recommended tolerance of 

0.07 ppm for nut, tree, group 14 and 

pistachios to 0.04 ppm. The reason for 

these changes are explained in Unit 

IV.D. 

In the Federal Register of October 1, 

2008 (73 FR 57040–57046) (FRL–8382– 

4), EPA issued a proposed rule pursuant 

to sections 408(e) of the Federal Food, 

Drug and Cosmetic Act (FFDCA), 21 

U.S.C. 346a(d)(3). The rule proposed 

that 40 CFR 180.628 be amended by 

establishing time-limited tolerances for 

indirect or inadvertent residues of 

chlorantraniliprole, 3-bromo-N-[4- 

chloro-2-methyl-6-[(methylamino) 

carbonyl]phenyl]-1-(3-chloro-2- 

pyridinyl)-1 H-pyrazole-5-carboxamide, 

in or on cowpeas, forage and hay at 0.20 

parts per million (ppm); field peas, 

vines and hay at 0.20 ppm; forage, 

fodder and straw of cereal grains, crop 

group 16 at 0.20 ppm, grass forage, 

fodder and hay, crop group 17 at 0.20 

ppm; leaves of root and tuber 

vegetables, crop group 2 at 0.20 ppm; 

leeks at 0.20 ppm; nongrass animal 

feeds (forage, fodder, straw and hay), 

crop group 18 at 0.20 ppm; okra at 0.70 

ppm; onions, green at 0.20 ppm; onions, 

Welsh at 0.20 ppm; peanuts, hay at 0.20 

ppm; shallots at 0.20 ppm; soybeans, 

forage and hay at 0.20 ppm; strawberries 

at 1.2 ppm; and sugarcane, sugar at 0.20 

ppm. The proposal established a 60–day 

public comment period. There were no 

comments received in response to the 

proposed rule. 

This final rule completes Agency 

action on both the petition from E.I. Du 

Pont de Nemours and Company, DuPont 

Crop Protection, and EPA’s proposed 

rulemaking of October 1, 2008. 

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 the petitioned-for 

tolerances for residues of 

chlorantraniliprole on almond, hulls at 

5.0 ppm, nut, tree, group 14 at 0.04 ppm 

and pistachio at 0.04 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

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 toxicity 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 document 

Chlorantraniliprole (DPX-E2Y45). 

Human Health Risk Assessment for 

Proposed Uses on the Tree Nut Group 

and Pistachios and for Increases in the 

Established Tolerances for Pome Fruits, 

Stone Fruits, Grapes and Raisins due to 

the Removal of Adjuvant Restrictions 

from the Label for Pome Fruits, Stone 

30472 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Rules and Regulations 

Fruits, and Grapes, page 21 in docket ID 

number EPA–HQ–OPP–2008–0770. 

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 NOAEL in the toxicology study 

identified as appropriate for use in risk 

assessment. However, if a NOAEL 

cannot be determined, 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-term, and chronic-term 

risks are evaluated by 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 

document Chlorantraniliprole (DPXE2Y45). Human Health Risk Assessment 

for Proposed Uses on the Tree Nut 

Group and Pistachios and for Increases 

in the Established Tolerances for Pome 

Fruits, Stone Fruits, Grapes and Raisins 

due to the Removal of Adjuvant 

Restrictions from the Label for Pome 

Fruits, Stone Fruits, and Grapes, page 

10 in docket ID number EPA–HQ–OPP– 

2008–0770. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to chlorantraniliprole, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing chlorantraniliprole tolerances 

in 40 CFR 180.628. EPA assessed dietary 

exposures from chlorantraniliprole in 

food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

No such effects were identified in the 

toxicological studies for 

chlorantraniliprole; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Continuing Survey of Food Intake 

by Individuals (CSFII). As to residue 

levels in food, EPA assumed 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 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 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 acute exposures 

are estimated to be 26.862 parts per 

billion (ppb) for surface water and 1.06 

ppb for ground water. The estimated 

drinking water concentrations (EDWCs) 

of chlorantraniliprole for chronic 

exposures are 3.650 parts per billion 

(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 3.650 

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. EPA 

assessed residential exposure using the 

following assumptions. Although 

residential exposure could occur, due to 

the lack of toxicity identified for shortand 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–2007–0275, pages 36 through 

37). 

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. 

Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Rules and Regulations 30473 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There were no effects on fetal growth or 

post-natal 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 reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

chlorantraniliprole is complete. 

ii. There is no indication that 

chlorantraniliprole is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

chlorantraniliprole results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to chlorantraniliprole in drinking water. 

EPA used similarly conservative 

assumptions to assess post-application 

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 aPAD and 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. Shortterm, intermediate-term, and chronicterm 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 <1% of the cPAD for 

(children 1–2 years) 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. Chlorantraniliprole has 

been classified as a ‘‘not likely human 

carcinogen.’’ It 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 chromotagraphy/mass 

spectrometry/mass spectrometry (LC/ 

MS/MC) 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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are no international residue 

limits that affect the Agency’s 

recommendations at this time. There are 

no Canadian, CODEX or Mexican 

maximum residue limits (MRLs) for 

chlorantraniliprole that exists at this 

time. 

C. Response to Comments 

There were no comments received in 

response to the notice of filing or 

proposed rule. 

D. Revisions to Petitioned-For 

Tolerances 

EPA has determined that the 

appropriate tolerance level for the tree 

nut group and pistachios is 0.04 ppm. 

Residue field trial data for 

chloroantraniliprole on almonds and 

pecans showed that the highest 

observed residue level on nutmeats was 

0.016 ppm. Almonds and pecans are 

representative commodities for the tree 

nut group and pistachios. Evaluation of 

these field trial data with EPA’s 

statistical modeling procedures for field 

residue data indicates that a tolerance of 

0.04 ppm will be sufficient for the 

labeled uses on tree nuts and pistachios. 

The petitioner has requested a 

tolerance of 0.07 ppm for these 

commodities. A higher value was 

requested because the field trials were 

conducted without use of an adjuvant 

but the petitioner now seeks approval of 

a pesticide label allowing the use of 

30474 Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Rules and Regulations 

adjuvants. Adjuvants may increase 

residue levels of the pesticide by 

altering the pattern of deposition, 

retention and penetration. In the case of 

chlorantraniliprole, several supervised 

side-by-side studies conducted on 

grape, peach, plum, and cherry with 

chlorantraniliprole alone and in the 

presence of an adjuvant, methylated 

seed oils or non-ionic surfactants 

showed that the adjuvants increased the 

level of chlorantraniliprole by an 

average factor of 2.1. EPA does not 

believe, however, that use of an 

adjuvant would increase 

chlorantraniliprole residues in nutmeats 

from the tree nut crop group and 

pistachios because these foods have 

very limited exposure to an applied 

non-systemic chemical such as 

chlorantraniliprole due to the physical 

barrier, known as the exocarp (i.e., husk 

or hull), surrounding the edible 

commodity. Thus, the Agency does not 

expect any increase in residue with the 

use of an adjuvant on the tree nut group 

or pistachios and EPA has revised the 

requested tolerance amount for these 

commodities downward to 0.04 ppm. 

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)-1 H-pyrazole-5- 

carboxamide, in or on almond, hulls at 

5.0 ppm, nut, trees, group 14 at 0.04 

ppm and pistachios at 0.04 ppm. In 

addition, time-limited rotational crop 

tolerances are established for residues of 

chlorantraniliprole in or on cowpeas, 

forage and hay at 0.20 parts per million 

(ppm); field peas, vines and hay at 0.20 

ppm; forage, fodder and straw of cereal 

grains, crop group 16 at 0.20 ppm, grass 

forage, fodder and hay, crop group 17 at 

0.20 ppm; leaves of root and tuber 

vegetables, crop group 2 at 0.20 ppm; 

leeks at 0.20 ppm; nongrass animal 

feeds (forage, fodder, straw and hay), 

crop group 18 at 0.20 ppm; okra at 0.70 

ppm; onions, green at 0.20 ppm; onions, 

Welsh at 0.20 ppm; peanuts, hay at 0.20 

ppm; shallots at 0.20 ppm; soybeans, 

forage and hay at 0.20 ppm; strawberries 

at 1.2 ppm; and sugarcane, sugar at 0.20 

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). 

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). 

Pursuant to the Regulatory Flexibility 

Act (RFA) (5 U.S.C. 601 et seq.), the 

Agency hereby certifies that this 

proposed action will not have 

significant negative economic impact on 

a substantial number of small entities. 

Establishing a pesticide tolerance or an 

exemption from the requirement of a 

pesticide tolerance is, in effect, the 

removal of a regulatory restriction on 

pesticide residues in food and thus such 

an action will not have any negative 

economic impact on any entities, 

including small entities. 

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: June 11, 2009. 

Debra Edwards, 

Director, 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 by 

alphabetically adding the following 

commodities to the table in paragraph 

(a), and revising paragraph (d) to read as 

follows: 

§ 180.628 Chlorantraniliprole; tolerances 

for residues. 

(a) * * * 

Commodity Parts per million 

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

* * * * * 

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

* * * * * 

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

* * * * * 

* * * * * 

(d) Indirect or inadvertent residues. 

Time-limited tolerances are established 

for indirect or inadvertent residues of 

the insecticide chlorantraniliprole (3- 

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

Federal Register / Vol. 74, No. 122 / Friday, June 26, 2009 / Rules and Regulations 30475 

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

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

carboxamide) in or on the following 

commodities. The tolerances will expire 

and are revoked on the dates specified 

in the following table. 

Commodity Parts per million Expiration/ 

revocation date 

Animal feed, nongrass, group 18 ................................................................................................................ 0.20 04/10/10 

Cowpea, forage ........................................................................................................................................... 0.20 04/10/10 

Cowpea, hay ................................................................................................................................................ 0.20 04/10/10 

Field pea, hay .............................................................................................................................................. 0.20 04/10/10 

Field pea, vine ............................................................................................................................................. 0.20 04/10/10 

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

Grass, forage, fodder and hay, group 17 .................................................................................................... 0.20 04/10/10 

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

Okra ............................................................................................................................................................. 0.70 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 

Strawberry .................................................................................................................................................... 1.20 04/10/10 

Sugarcane .................................................................................................................................................... 0.20 04/10/10 

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

[FR Doc. E9–14996 Filed 6–25–09; 8:45 am] 

BILLING CODE 6560–50–S 

GENERAL SERVICES 

ADMINISTRATION 

41 CFR Part 102–118 

[FMR Amendment 2009–04; FMR Case 

2009–102–4; Docket 2009–0002; Sequence 

3] 

RIN 3090–AI91 

Federal Management Regulation; 

Transportation Payment and Audit 

AGENCY: Office of Governmentwide 

Policy, General Services Administration 

(GSA). 

ACTION: Final rule. 

SUMMARY: The General Services 

Administration (GSA) is amending the 

Federal Management Regulation (FMR) 

covering Transportation Payment and 

Audit. This final rule updates 

information and corrects mailing and 

web site addresses. 

DATES: Effective Date: This final rule is 

effective June 26, 2009. 

FOR FURTHER INFORMATION CONTACT: The 

Regulatory Secretariat, Room 4035, GS 

Building, Washington, DC 20405, (202) 

208–7312, for information pertaining to 

status or publication schedules. For 

clarification of content, contact Patrick 

O’Grady at (202) 208–4493. Please cite 

FMR case 2009–102–4, Amendment 

2009–04. 

SUPPLEMENTARY INFORMATION: 

A. Background 

Federal Management Regulation 

(FMR) part 102–118 (41 CFR part 102– 

118, Transportation Payment and 

Audit) was last reviewed and amended 

on September 24, 2004 (69 FR 57617). 

GSA collaborated with four agencies to 

conduct a review and determine if it is 

still current and accurate. This final rule 

reflects the changes recommended by 

GSA and the other four agencies. 

Because the changes only apply to 

administrative matters, GSA has 

determined it is not necessary to 

comment on this amendment. 

B. Substantive Changes 

This revision eliminates references to 

the GSA’s Federal Supply Service, 

which was reorganized after the 

regulation was last published and is 

now called the GSA’s Federal 

Acquisition Service (FAS). It also 

updates addresses and names of other 

GSA business lines, and it provides a 

new address for courier mail for the 

Civilian Board of Contract Appeals. 

C. Executive Order 12866 

GSA has determined that this final 

rule is not a significant regulatory action 

for the purposes of Executive Order 

12866. 

D. Regulatory Flexibility Act 

This final rule will not have a 

significant economic impact on a 

substantial number of small entities 

within the meaning of the Regulatory 

Flexibility Act, 5 U.S.C. 601, et seq. 

Because the final rule only applies to 

internal agency management, it will not 

have a significant effect on the public. 

E. Paperwork Reduction Act 

The Paperwork Reduction Act does 

not apply because the changes to the 

FMR do not impose information 

collection requirements that require the 

approval of the Office of Management 

and Budget under 44 U.S.C. 3501, et 

seq. 

F. Small Business Regulatory 

Enforcement Fairness Act 

This final rule is exempt from 

Congressional review under 5 U.S.C. 

801 since it relates solely to agency 

management and personnel. 

List of Subjects in 41 CFR Part 102–118 

Accounting, Claims, Government 

property management, Reporting and 

recordkeeping requirements, Surplus 

Government property, Transportation. 

Dated: May 29, 2009. 

Paul F. Prouty, 

Acting Administrator of General Services. 

■ For the reasons set forth in the 

preamble, GSA is amending 41 CFR part 

102–118 as set forth below: 

PART 102–118—TRANSPORTATION 

PAYMENT AND AUDIT 

■ 1. The authority citation for 41 CFR 

part 102–118 continues to read as 

follows: 

Authority: 31 U.S.C. 3726; 40 U.S.C. 

121(c), and 49 U.S.C. 10721, 13712, and 

15504. 

■ 2. Amend part 102–118 by removing 

‘‘Federal Supply Service Audit Division 

(FBA), 1800 F Street, NW., Washington, 

DC 20405’’ wherever it appears, and 

adding ‘‘Transportation Audit Division 

(QMCA), Crystal Plaza 4, Room 300, 

2200 Crystal Drive, Arlington, VA 

22202’’ in its place. 

■ 3. Amend § 102–118.35 by revising 

the definition of ‘‘Government Bill of 

Lading (GBL)’’ to read as follows: