Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations 47057 

Department that it is funding an OTRB 

or Other Than Urbanized grant by 

transmitting to the Department an 

information copy of each grant 

application upon approval of the grant. 

(i) Each grant of assistance for an 

Other Than Urbanized program will 

contain a labor section identifying labor 

organizations representing transit 

employees of each subrecipient, the 

labor organizations representing 

employees of other transit providers in 

the service area, and a list of those 

transit providers. A sample format is 

posted on the OLMS Web site to 

facilitate the inclusion of this 

information in the grant application. 

(ii) OTRB grants of assistance will 

contain a labor section identifying labor 

organizations representing employees of 

the recipient. 

(2) The Department will notify labor 

organizations representing potentially 

affected transit employees of the 

approval of Other Than Urbanized and 

OTRB grants and inform them of their 

rights under the Special Warranty 

Arrangement. 

§ 215.8 [Amended] 

■ 8. Section 215.8 is amended as 

follows: 

■ a. Remove ‘‘Director,’’ and add in its 

place ‘‘Chief, Division of’’; 

■ b. Remove ‘‘Suite N5603,’’; and 

■ c. Add the phrase ‘‘or e-mailed to 

OLMS-TransitGrant@dol.gov’’ at the end 

of the paragraph. 

Signed at Washington, DC, this 4th day of 

August, 2008. 

Victoria A. Lipnic, 

Assistant Secretary for Employment 

Standards. 

Donald Todd, 

Deputy Assistant Secretary, Office of LaborManagement Standards. 

[FR Doc. E8–18497 Filed 8–12–08; 8:45 am] 

BILLING CODE 4510–CP–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0099; FRL–8360–2] 

Flubendiamide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of the insecticide 

flubendiamide per se, N2-[1,1-Dimethyl2-(methylsulfonyl)ethyl-3-iodo-N1-[2- 

methyl-4-[1,2,2,2-tetrafluoro-1- 

(trifluoromethyl)ethyl]phenyl]-1,2- 

benzenedicarboxamide, in or on certain 

food and raw agricultural commodities. 

Bayer CropScience, LP in c/o Nichino 

America, Inc. (U.S. subsidiary of Nihon 

Nohyaku Co., Ltd.) requested these 

tolerances under the Federal Food, Drug 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 13, 2008. Objections and 

requests for hearings must be received 

on or before October 14, 2008, 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–2007–0099. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

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 Room S–

4400, One Potomac Yard (South 

Building), 2777 S. Crystal Drive, 

Arlington, VA 22202–4501. 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: 

Carmen Rodia, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Avenue, NW., 

Washington, DC 20460–0001; telephone 

number: (703) 306–0327; e-mail address: 

rodia.carmen@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 an electronic 

copy of this Federal Register document 

through the electronic docket 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 pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr. To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gpo/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2007–0099 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 October 14, 2008. 

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 


hsrobinson on PROD1PC76 with RULES
47058 Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations 

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–2007–0099, 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 Avenue, NW., 

Washington, DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Room S–4400, One 

Potomac Yard (South Building), 2777 S. 

Crystal Drive, Arlington, VA 22202–

4501. Deliveries are only accepted 

during the Docket’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 February 

28, 2007 (72 FR 9000) (FRL–8115–2), 

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 6F7065) by Bayer 

CropScience, LP in c/o Nichino 

America, Inc. (U.S. subsidiary of Nihon 

Nohyaku Co., Ltd.), P.O. Box 12014, 

Research Triangle Park, NC 27709–2014. 

The petition requested that 40 CFR part 

180 be amended by establishing 

permanent tolerances in primary crops 

for residues of the insecticide 

flubendiamide, N2-[1,1-Dimethyl-2- 

(methylsulfonyl)ethyl-3-iodo-N1-[2- 

methyl-4-[1,2,2,2-tetrafluoro-1- 

(trifluoromethyl)ethyl]phenyl]-1,2- 

benzenedicarboxamide, in or on the 

following raw agricultural and 

processed commodities: Almond, hulls 

at 9.0 parts per million (ppm); brassica, 

head and stem subgroup at 0.60 ppm; 

brassica, leafy greens subgroup at 6.0 

ppm; corn, field, forage at 8.0 ppm; 

corn, corn, field, grain at 0.02 ppm; 

field, stover at 15.0 ppm; corn, pop, 

grain at 0.02 ppm; corn, pop, stover at 

15.0 ppm; corn, sweet, forage at 9.0 

ppm; corn, sweet, kernel plus cob with 

husks removed at 0.02 ppm; corn, 

sweet, stover at 25.0 ppm; cottonseed at 

2.0 ppm; cotton, gin byproduct at 60.0 

ppm; fruit, pome group at 0.7 ppm; 

fruit, stone group at 1.6 ppm; grape at 

1.4 ppm; nut, tree group at 0.06 ppm; 

okra at 0.30 ppm; vegetable, cucurbit 

group at 0.20 ppm; vegetable, fruiting 

group at 0.30 ppm and vegetable, leafy, 

except brassica at 11.0 ppm; in or on the 

following rotational crop commodities: 

Alfalfa, forage at 0.15 ppm; alfalfa, hay 

at 0.04 ppm; barley, hay at 0.04 ppm; 

barley, straw at 0.07 ppm; buckwheat at 

0.07 ppm; clover, forage at 0.15 ppm; 

clover, hay at 0.04 ppm; grass, forage at 

0.15 ppm; grass, hay at 0.04 ppm; grass, 

silage at 0.27 ppm; millet, pearl, forage 

at 0.15 ppm; millet, pearl hay at 0.04 

ppm; millet, proso, forage at 0.15 ppm; 

millet, proso, hay at 0.04 ppm; millet, 

proso, straw at 0.07 ppm; oats, forage at 

0.15 ppm; oats, hay at 0.04 ppm; oats, 

straw at 0.07 ppm; rye, forage at 0.15 

ppm; rye, straw at 0.07 ppm; sorghum, 

grain, forage at 0.03 ppm; sorghum, 

grain, stover at 0.06 ppm; soybean, 

forage at 0.02 ppm; soybean, hay at 0.04 

ppm; teosinte, forage at 0.15 ppm; 

teosinte, hay at 0.04 ppm; teosinte, 

straw at 0.07 ppm; triticale, forage at 

0.15 ppm; triticale, hay at 0.04 ppm; 

triticale, straw at 0.07 ppm; wheat, 

forage at 0.15 ppm; wheat, hay at 0.03 

ppm and wheat, straw at 0.03 ppm; and 

in the following livestock commodities: 

Cattle, fat at 0.80 ppm; cattle, kidney at 

0.60 ppm; cattle, liver at 0.60 ppm; 

cattle, muscle at 0.10 ppm; eggs at 0.03 

ppm; goat, fat at 0.80 ppm; goat, kidney 

at 0.60 ppm; goat, liver at 0.60 ppm; 

goat, muscle at 0.10 ppm; hog, fat at 

0.80 ppm; hog, kidney at 0.60 ppm; hog, 

liver at 0.60 ppm; hog, muscle at 0.10 

ppm; horse, fat at 0.80 ppm; horse, 

kidney at 0.60 ppm; horse, liver at 0.60 

ppm; horse, muscle at 0.10 ppm; milk 

at 0.20 ppm; poultry, fat at 0.08 ppm; 

poultry, liver at 0.03 ppm; poultry, 

muscle at 0.01 ppm; sheep, fat at 0.80 

ppm; sheep, kidney at 0.60 ppm; sheep, 

liver at 0.60 ppm; and sheep, muscle at 

0.10 ppm. That notice referenced a 

summary of the petition prepared by 

Bayer CropScience, LP in c/o Nichino 

America, Inc. (U.S. subsidiary of Nihon 

Nohyaku Co., Ltd.), 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 this petition and EPA policy, 

the Agency has revised commodity 

definitions and/or some of the proposed 

tolerances and concludes that the 

establishment of the following tolerance 

is appropriate for the insecticide 

flubendiamide per se in or on the 

following food commodities: Almond, 

hulls at 9.0 ppm; apple, wet pomace at 

2.0 ppm; brassica, head and stem, 

subgroup 5A at 0.60 ppm; brassica, 

leafy greens, subgroup 5B at 5.0 ppm; 

cattle, fat at 0.30 ppm; cattle, kidney at 

0.30 ppm; cattle, liver at 0.30 ppm; 

cattle, muscle at 0.05 ppm; corn, field, 

forage at 8.0 ppm; corn, field, grain at 

0.02 ppm; corn, field, stover at 15 ppm; 

corn, pop, grain at 0.02 ppm; corn, pop, 

stover at 15 ppm; corn, sweet, forage at 

9.0 ppm; corn, sweet, kernel plus cob 

with husks removed at 0.01 ppm; corn, 

sweet, stover at 25 ppm; cotton gin 

byproducts at 60 ppm; cotton, 

undelinted seed at 0.90 ppm; egg at 0.01 

ppm; fruit, pome, group 11 at 0.70 ppm; 

fruit, stone, group 12 at 1.6 ppm; goat, 

fat at 0.30 ppm; goat, kidney at 0.30 

ppm; goat, liver at 0.30 ppm; goat, 

muscle at 0.05 ppm; grain, aspirated 

fractions at 5.0 ppm; grape at 1.4 ppm; 

horse, fat at 0.30 ppm; horse, kidney at 

0.30 ppm; horse, liver at 0.30 ppm; 

horse, muscle at 0.05 ppm; milk at 0.04 

ppm; milk, fat at 0.30 ppm; nut, tree, 

group 14 at 0.06 ppm; okra at 0.30 ppm; 

poultry, fat at 0.02 ppm; poultry, liver 

at 0.01 ppm; poultry, muscle at 0.01 

ppm; sheep, fat at 0.30 ppm; sheep, 

kidney at 0.30 ppm; sheep, liver at 0.30 

ppm; sheep, muscle at 0.05 ppm; 

vegetable, cucurbit, group 9 at 0.20 

ppm; vegetable, fruiting, group 8 at 0.60 

ppm and vegetable, leafy, except 

brassica, group 4 at 11 ppm; and in or 

on the following raw agricultural 

commodities: Alfalfa, forage at 0.15 

ppm; alfalfa, hay at 0.04 ppm; barley, 

hay at 0.04 ppm; barley, straw at 0.07 

ppm; buckwheat at 0.07 ppm; clover, 

forage at 0.15 ppm; clover, hay at 0.04 

ppm; grass, forage at 0.15 ppm; grass, 

hay at 0.04 ppm; millet, pearl, forage at 

0.15 ppm; millet, pearl, hay at 0.04 

ppm; millet, proso, forage at 0.15 ppm; 

millet, proso, hay at 0.04 ppm; millet, 

proso, straw at 0.07 ppm; oats, forage at 

0.15 ppm; oats, hay at 0.04 ppm; oats, 

straw at 0.07 ppm; rye, forage at 0.15 

ppm; rye, straw at 0.07 ppm; sorghum, 

grain, forage at 0.03 ppm; sorghum, 

grain, stover at 0.06 ppm; soybean, 

forage at 0.02 ppm; soybean, hay at 0.04 

ppm; teosinte, forage at 0.15 ppm; 

teosinte, hay at 0.04 ppm; teosinte, 

straw at 0.07 ppm; triticale, forage at 

0.15 ppm; triticale, hay at 0.04 ppm; 

triticale, straw at 0.07 ppm; wheat, 

forage at 0.15 ppm; wheat, hay at 0.03 

ppm and wheat, straw at 0.03 ppm. 

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 


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Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations 47059 

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 

submitted 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 the insecticide 

flubendiamide. 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. 

Flubendiamide has low acute toxicity 

via the oral and dermal routes, is only 

a slight eye irritant, is non-irritating to 

the dermis and tests negative for skin 

sensitization. In the longer-term studies 

in the flubendiamide mammalian 

toxicology database, the primary target 

organs identified were the liver, thyroid, 

kidney and eyes. Liver effects reported 

in rats, mice and/or dogs include organ 

weight increase, periportal fatty change, 

hypertrophy and minimal foci of 

cellular alteration. Thyroid effects 

include organ weight increase, follicular 

cell hypertrophy and slight 

perturbations of triiodothyronine (TC) 

and thyroid stimulating hormone (TSH) 

in the rat and mouse. Kidney effects 

include increases in absolute and/or 

relative to body kidney weights and 

chronic nephropathy in the rat. Eye 

effects include eye enlargement, opacity 

and exophthalmus with hemorrhage and 

appear only in rat pups. Other changes 

include mild microcytic anemia, 

decreased serum triglycerides and 

cholesterol in female rat, increased 

gamma glutamyl peptidase, alkaline 

phosphatase and shortened activated 

prothrombin time in dogs, and adrenal 

weight increase and an increase in 

adrenal cortical cell hypertrophy in 

dogs. 

The hazard assessment indicated 

potential toxicity resulting from 

exposure to flubendiamide via different 

routes over different durations. The 

observed eye effects were selected as a 

critical effect for the acute dietary 

exposure scenario; whereas liver and 

thyroid effects were determined critical 

for the chronic dietary exposure 

scenario. Short-term and intermediateterm dermal risks were also based on 

liver and thyroid effects as well as blood 

effects. Short-term and intermediateterm inhalation risks are based on liver 

toxicity as well as adrenal weight 

increase and an increase in adrenal 

cortical cell hypertrophy. 

There was no evidence of 

carcinogenicity in rats and mice up to 

the limit dose at 24– and 18–months, 

respectively. Flubendiamide was 

determined to be non-mutagenic in 

bacteria, negative in an in vivo 

mammalian cytogenetics assay and did 

not cause unscheduled DNA synthesis 

(repair of DNA damage) in mammalian 

cells in vitro. Overall, there was no clear 

evidence that flubendiamide was either 

mutagenic or clastogenic in either in 

vivo or in vitro assays. The cancer 

classification is ‘‘Not Likely to be 

Carcinogenic to Humans.’’

More detailed information on the 

studies received and the nature of the 

adverse effects caused by flubendiamide 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

in the document entitled, 

‘‘Flubendiamide: Human Health Risk 

Assessment for Proposed Uses on Corn, 

Cotton, Tobacco, Tree fruit, Tree nuts, 

Vine crops and Vegetable crops,’’ dated 

April 3, 2008, by going to http:// 

www.regulations.gov. The referenced 

document is available in the docket 

established by this action, which is 

described under ADDRESSES, and is 

identified as EPA–HQ–OPP–2007–

0099–0005 in that docket. Locate and 

click on the hyperlink for docket ID 

number EPA–HQ–OPP–2007–0099. 

Double-click on the document to view 

the referenced information on pages 65–

70 of 105. 

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-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, refer to http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for flubendiamide used for 

human risk assessment can be found in 

the document entitled, ‘‘Flubendiamide: 

Human Health Risk Assessment for 

Proposed Uses on Corn, Cotton, 

Tobacco, Tree fruit, Tree nuts, Vine 

crops and Vegetable crops,’’ dated April 

3, 2008, by going to http:// 

www.regulations.gov. The referenced 

document is available in the docket 

established by this action, which is 

described under ADDRESSES, and is 

identified as EPA–HQ–OPP–2007–

0099–0005 in that docket. Locate and 

click on the hyperlink for docket ID 

number EPA–HQ–OPP–2007–0099. 

Double-click on the document to view 

the referenced information on pages 37–

38 of 105. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to flubendiamide, EPA 

considered exposure under the 


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47060 Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations 

petitioned-for tolerances and assessed 

dietary exposures from flubendiamide 

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. In estimating acute dietary 

exposure, EPA used food consumption 

information from the Dietary Exposure 

Evaluation Model-Food Commodity 

Intake Database (DEEM-FCIDTM, 

Version 2.03), which incorporates food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

Nationwide Continuing Surveys of Food 

Intakes by Individuals (CSFII) from 

1994–1996 and 1998. The acute 

assessments assumed that 100% of 

crops with requested uses of 

flubendiamide are treated and that all 

treated crops contain residues at 

tolerance-level. In addition, tolerancelevel residues for livestock commodities 

were included in these analyses to 

account for the potential transfer of 

plant residues to livestock tissues. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used DEEM-FCIDTM, 

Version 2.03, which incorporates food 

consumption data from the USDA’s 

CSFII from 1994–1996 and 1998. The 

chronic assessments assumed that 100% 

of crops with requested uses of 

flubendiamide are treated and that all 

treated crops contain residues at the 

average residue levels found in the crop 

field trials and experimentallydetermined processing factors where 

available. In addition, average-level 

residues for livestock commodities were 

also included in these analyses to 

account for the potential transfer of 

plant residues to livestock tissues. 

iii. Cancer. As explained in Unit 

III.A., flubendiamide is considered to be 

‘‘Not Likely to be Carcinogenic to 

Humans.’’ As a result, cancer exposure 

assessment is not needed for 

flubendiamide. 

iv. Anticipated residue information. 

Section 408(b)(2)(E) of FFDCA 

authorizes EPA to use available data and 

information on the anticipated residue 

levels of pesticide residues in food and 

the actual levels of pesticide residues 

that have been measured in food. If EPA 

relies on such information, EPA must 

require pursuant to FFDCA section 

408(f)(1) that data be provided 5 years 

after the tolerance is established, 

modified or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for flubendiamide in drinking water. 

These simulation models take into 

account data on the physical, chemical 

and fate/transport characteristics of 

flubendiamide. 

Flubendiamide is persistent and 

potentially mobile in terrestrial and 

aquatic environments. These fate 

properties suggest that it has a potential 

to move into surface and ground water. 

The Agency lacks sufficient monitoring 

exposure data for use in risk 

assessments, as flubendiamide is a new 

active ingredient. Because the Agency 

does not have comprehensive 

monitoring data, drinking water 

concentration estimates are made by 

reliance on simulation or modeling, 

taking into account data on the physical 

and fate characteristics of 

flubendiamide. 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 the 

Screening Concentration in Ground 

Water (SCI-GROW) model, the estimated 

drinking water concerns (EDWCs) of 

flubendiamide for acute exposures are 

estimated to be 12.93 parts per billion 

(ppb) for surface water and 0.06 ppb for 

ground water. For chronic exposures for 

non-cancer assessments, the EDWCs are 

estimated to be 11.95 ppb for surface 

water and 0.06 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 12.93 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 11.95 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). 

Flubendiamide is not registered for any 

specific use patterns that would result 

in residential exposure. That is, no 

residential uses are being requested for 

flubendiamide at this time; therefore, no 

residential risk assessment has been 

conducted. 

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 flubendiamide to 

share a common mechanism of toxicity 

with any other substances, and 

flubendiamide does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action; therefore, EPA has 

assumed that flubendiamide 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 ten-fold (10x) margin of 

safety for infants and children in the 

case of threshold effects to account for 

pre-natal and/or post-natal toxicity, and 

the completeness of the database on 

toxicity and exposure, unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. This additional 

margin of safety is commonly referred to 

as the Food Quality Protection Act 

Safety Factor (FQPA SF). In applying 

this provision, EPA either retains the 

default value of 10x or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Pre-natal and post-natal sensitivity. 

While both the rat and rabbit 

developmental studies did not identify 

teratogenic effects and showed no 

evidence of increased pre-natal 

susceptibility, adverse eye effects (eye 

enlargement) were noted in post-natal 

rat pups older than 14 days in multiple 

studies (the 2–generation reproduction 

and 1–generation supplemental studies) 

and the developmental neurotoxicity 

(DNT) study reported eye effects 

appearing in some offspring between 

lactation days 14 and 42, even though 

exposure stopped at lactation day 21, 

indicating a possible delay (a latent 

response) from the time of last exposure 

to onset of bupthalmos. These eye 


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Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations 47061 

effects did not occur in adult rats. Since 

the iris and chamber angle are 

differentiating and specializing into 

definite structures during post-natal 

days 5–20, neonatal rats appear to have 

an increased susceptibility to 

flubendiamide exposure as compared to 

adults. The DNT study also reported 

that pre-mating exposures are not 

required to elicit the eye effect in pups. 

In addition to the reported eye effects in 

the DNT study, there was also a balanopreputial separation (separation of the 

prepuce (foreskin) from the glans penis 

(balanus)) delay. While these effects are 

considered adverse, they are not 

assumed to be developmental effects 

from in utero exposure. Even though the 

delay in balanopreputial separation may 

be a result of post-natal exposure 

(sensitivity of the young), and the effect 

is adverse, it is considered reversible 

and not an indication of perinatal 

sensitivity/susceptibility. 

Human microsomes have been shown 

to be capable of approximately 4 times 

higher hydroxylation rates of 

flubendiamide as compared to female 

mouse microsomes and may be able to 

efficiently metabolize and excrete 

flubendiamide, preventing 

accumulation of the parent compound. 

It remains unclear whether the ability to 

metabolize and clear the parent 

compound is the only requirement to 

avoid ocular toxicity. Due to the 

potential concern for increased 

susceptibility of the human neonate as 

compared to adults, this perinatal ocular 

effect is considered in the human health 

risk assessment for flubendiamide. 

3. Conclusion. EPA evaluated the 

quality of the toxicity and exposure data 

and, based on these data, has 

determined that 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 toxicology database for 

flubendiamide is complete for purposes 

of this risk assessment and the 

characterization of potential pre-natal 

and/or post-natal risks to infants and 

children. Although susceptibility was 

identified in the toxicological database 

(eye effects), the selected regulatory 

PODs (which are based on clear 

NOAELs) are protective of these effects; 

therefore, the human health risk 

assessment is protective. 

ii. There are no treatment-related 

neurotoxic findings in the acute 

neurotoxicity and DNT studies in rats; 

although eye effects were observed in 

the DNT study. As noted in the previous 

paragraph, the PODs employed in the 

risk assessment are protective of this 

effect. 

iii. There are no residual uncertainties 

identified in the exposure databases and 

the exposure assessment is protective. 

The acute dietary food exposure 

assessment utilizes tolerance-level 

residues, the chronic dietary food 

exposure assessment utilizes average 

residue levels found in the crop field 

trials/livestock commodities and both 

assume 100% of crops with requested 

uses of flubendiamide are treated. The 

drinking water assessment generated 

EDWCs using models and associated 

modeling parameters which are 

designed to provide conservative, health 

protective, high-end estimates of water 

concentrations. The highest relevant 

EDWCs were used in the dietary (food 

and drinking water) exposure 

assessment. By using these screeninglevel exposure assessments in the acute 

and chronic dietary (food and drinking 

water) assessments, risk is not 

underestimated for flubendiamide. 

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. 

For flubendiamide, there is potential 

exposure from food and drinking water, 

but not from residential use sites (as 

there are no proposed residential uses 

for flubendiamide). Since hazard was 

identified via the oral route over both 

the acute and chronic duration, the 

aggregate risk assessment considers 

exposures from food and drinking water 

consumed over the acute and chronic 

durations. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

flubendiamide will occupy less than 8% 

of the aPAD for the mostly highly 

exposed population subgroup, children 

aged 1–2 years old. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to flubendiamide 

from food and water will utilize less 

than 15% of the cPAD for the mostly 

highly exposed population subgroup, 

children aged 1–2 years old. There are 

no residential uses for flubendiamide. 

3. Aggregate cancer risk for U.S. 

population. Flubendiamide has been 

classified as ‘‘Not Likely to be 

Carcinogenic to Humans’’ and is not 

expected to pose a cancer risk. 

4. 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 

flubendiamide residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(LC/MS/MS, Methods 00816/M002 and 

00912) is available to enforce the 

tolerance expression. The method may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Road, Fort 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are currently no established 

CODEX, Canadian or Mexican 

maximum residue limits (MRLs) for 

residues of flubendiamide in or on 

various crop or livestock commodities. 

C. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

submitted in support of this tolerance 

petition for flubendiamide and EPA 

policy, the Agency has revised 

commodity definitions and/or some of 

the proposed tolerances. No residue 

data were submitted to support the 

proposed uses on okra and popcorn. 

The available field trial data for fruiting 

vegetables may be translated to okra, 

and the submitted data for field corn 

may also be translated to popcorn. The 

proposed uses on all types of corn (field, 

pop and sweet) are identical. 

Parent residue levels vary based on 

crop (for edible commodities, residues 

ranging from 0.018 ppm, corn, field, 

grain to 6.7 ppm, spinach). Most crops 

indicated parent residues declined with 

successive sampling dates and were 

determined to be available on the 

surface of plants/RACs. The Agency will 

allow translation of residue data from 

trials conducted on rotated barley, 

sorghum and wheat to support the 

proposed rotational crop tolerances for 

the forages, hay and straw of other types 

of cereal grains and grasses. The Agency 


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47062 Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations 

will also allow translation of residue 

data from trials conducted on rotated 

soybean to support the proposed 

rotational crop tolerances for the 

forages, fodder, hay and straw on alfalfa 

and clover to support the rotational 

plant-back intervals. Based on the 

transfer coefficients for livestock tissues 

and the relatively low dietary burden for 

swine of 0.02 ppm for flubendiamide, 

tolerances for hogs are not needed. 

V. Conclusion 

Therefore, tolerances are established 

forresidues of the insecticide 

flubendiamide per se, N2-[1,1-Dimethyl2-(methylsulfonyl)ethyl-3-iodo-N1-[2- 

methyl-4-[1,2,2,2-tetrafluoro-1- 

(trifluoromethyl)ethyl]phenyl]-1,2- 

benzenedicarboxamide. 

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 rule has 

been exempted from review under 

Executive Order 12866, this rule is not 

subject to Executive Order 13211, 

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 tolerances 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 rule. In addition, this 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: August 1, 2008. 

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 180.639 is added to read as 

follows: 

§ 180.639 Flubendiamide; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide flubendiamide per se, N2- 

[1,1-Dimethyl-2-(methylsulfonyl)ethyl3-iodo-N1-[2-methyl-4-[1,2,2,2- 

tetrafluoro-1- 

(trifluoromethyl)ethyl]phenyl]-1,2- 

benzenedicarboxamide, in or on the 

following food commodities: 

Commodity Parts per million 

Almond, hulls .................. 9.0 ppm 

Apple, wet pomace ......... 2.0 ppm 

Brassica, head and stem, 

subgroup 5A ................ 0.60 ppm 

Brassica, leafy greens, 

subgroup 5B ................ 5.0 ppm 

Cattle, fat ........................ 0.30 ppm 

Cattle, kidney .................. 0.30 ppm 

Cattle, liver ...................... 0.30 ppm 

Cattle, muscle ................. 0.05 ppm 

Corn, field, forage ........... 8.0 ppm 

Corn, field, grain ............. 0.02 ppm 

Corn, field, stover ........... 15 ppm 

Corn, pop, grain .............. 0.02 ppm 

Corn, pop, stover ............ 15 ppm 

Corn, sweet, forage ........ 9.0 ppm 

Corn, sweet, kernel plus 

cob with husks removed ......................... 0.01 ppm 

Corn, sweet, stover ........ 25 ppm 

Cotton, gin byproducts ... 60 ppm 

Cotton, undelinted seed 0.90 ppm 

Egg ................................. 0.01 ppm 

Fruit, pome, group 11 ..... 0.70 ppm 

Fruit, stone, group 12 ..... 1.6 ppm 

Goat, fat .......................... 0.30 ppm 

Goat, kidney ................... 0.30 ppm 

Goat, liver ....................... 0.30 ppm 

Goat, muscle .................. 0.05 ppm 

Grain, aspirated fractions 5.0 ppm 

Grape .............................. 1.4 ppm 

Horse, fat ........................ 0.30 ppm 

Horse, kidney .................. 0.30 ppm 

Horse, liver ..................... 0.30 ppm 

Horse, muscle ................. 0.05 ppm 

Milk ................................. 0.04 ppm 

Milk, fat ........................... 0.30 ppm 

Nut, tree, group 14 ......... 0.06 ppm 

Okra ................................ 0.30 ppm 

Poultry, fat ...................... 0.02 ppm 

Poultry, liver .................... 0.01 ppm 

Poultry, muscle ............... 0.01 ppm 

Sheep, fat ....................... 0.30 ppm 

Sheep, kidney ................. 0.30 ppm 

Sheep, liver ..................... 0.30 ppm 

Sheep, muscle ................ 0.05 ppm 

Vegetable, cucurbit, 

group 9 ........................ 0.20 ppm 

Vegetable, fruiting, group 

8 .................................. 0.60 ppm 

Vegetable, leafy, except 

Brassica, group 4 ........ 11 ppm 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

indirect or inadvertent residues of the 


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Federal Register / Vol. 73, No. 157 / Wednesday, August 13, 2008 / Rules and Regulations 47063 

insecticide flubendiamide per se, N2- 

[1,1-Dimethyl-2-(methylsulfonyl)ethyl3-iodo-N1-[2-methyl-4-[1,2,2,2- 

tetrafluoro-1- 

(trifluoromethyl)ethyl]phenyl]-1,2- 

benzenedicarboxamide, in or on the 

following raw agricultural commodities 

when present therein as a result of the 

application of flubendiamide per se to 

the growing crops listed in paragraph (a) 

of this section: 

Commodity Parts per million 

Alfalfa, forage ................. 0.15 ppm 

Alfalfa, hay ...................... 0.04 ppm 

Barley, hay ...................... 0.04 ppm 

Barley, straw ................... 0.07 ppm 

Buckwheat ...................... 0.07 ppm 

Clover, forage ................. 0.15 ppm 

Clover, hay ..................... 0.04 ppm 

Grass, forage .................. 0.15 ppm 

Grass, hay ...................... 0.04 ppm 

Millet, pearl, forage ......... 0.15 ppm 

Millet, pearl, hay ............. 0.04 ppm 

Millet, proso, forage ........ 0.15 ppm 

Millet, proso, hay ............ 0.04 ppm 

Millet, proso, straw ......... 0.07 ppm 

Oats, forage .................... 0.15 ppm 

Oats, hay ........................ 0.04 ppm 

Oats, straw ..................... 0.07 ppm 

Rye, forage ..................... 0.15 ppm 

Rye, straw ....................... 0.07 ppm 

Sorghum, grain, forage ... 0.03 ppm 

Sorghum, grain, stover ... 0.06 ppm 

Soybean, forage ............. 0.02 ppm 

Soybean, hay .................. 0.04 ppm 

Teosinte, forage .............. 0.15 ppm 

Teosinte, hay .................. 0.04 ppm 

Teosinte, straw ............... 0.07 ppm 

Triticale, forage ............... 0.15 ppm 

Triticale, hay ................... 0.04 ppm 

Triticale, straw ................ 0.07 ppm 

Wheat, forage ................. 0.15 ppm 

Wheat, hay ..................... 0.03 ppm 

Wheat, straw ................... 0.03 ppm 

[FR Doc. E8–18324 Filed 8–12–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0565; FRL–8374–5] 

Tribenuron Methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of tribenuron 

methyl in or on barley, hay; oat, forage; 

oat, hay; wheat, forage; and wheat, hay. 

E. I. DuPont de Nemours and Company 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 13, 2008. Objections and 

requests for hearings must be received 

on or before October 14, 2008, 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–2007–0565. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

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 either 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: 

Vickie Walters, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5704; e-mail address: 

walters.vickie@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 an electronic 

copy of this Federal Register document 

through the electronic docket 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 pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2007–0565 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 October 14, 2008. 

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–2007–0565, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 


hsrobinson on PROD1PC76 with RULES