Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Rules and Regulations 69353 

(ix) Feather River Air Quality 

Management District, 1007 Live Oak 

Blvd., Suite B–3, Yuba City, CA 95991. 

(x) Glenn County Air Pollution 

Control District, 720 N. Colusa Street, 

P.O. Box 351, Willows, CA 95988–0351. 

(xi) Great Basin Unified Air Pollution 

Control District, 157 Short Street, Suite 

6, Bishop, CA 93514–3537. 

(xii) Imperial County Air Pollution 

Control District, 150 South Ninth Street, 

El Centro, CA 92243–2801. 

(xiii) Lake County Air Quality 

Management District, 885 Lakeport 

Blvd., Lakeport, CA 95453–5405. 

(xiv) Lassen County Air Pollution 

Control District, 707 Nevada Street, 

Suite 1, Susanville, CA 96130. 

(xv) Mariposa County Air Pollution 

Control District, P.O. Box 5, Mariposa, 

CA 95338. 

(xvi) Mendocino County Air Quality 

Management District, 306 E. Gobbi 

Street, Ukiah, CA 95482–5511. 

(xvii) Modoc County Air Pollution 

Control District, 619 North Main Street, 

Alturas, CA 96101. 

(xviii) Mojave Desert Air Quality 

Management District, 14306 Park 

Avenue, Victorville, CA 92392–2310. 

(xix) Monterey Bay Unified Air 

Pollution Control District, 24580 Silver 

Cloud Court, Monterey, CA 93940. 

(xx) North Coast Unified Air Quality 

Management District, 2300 Myrtle 

Avenue, Eureka, CA 95501–3327. 

(xxi) Northern Sierra Air Quality 

Management District, 200 Litton Drive, 

Suite 320, P.O. Box 2509, Grass Valley, 

CA 95945–2509. 

(xxii) Northern Sonoma County Air 

Pollution Control District, 150 Matheson 

Street, Healdsburg, CA 95448–4908. 

(xxiii) Placer County Air Pollution 

Control District, 3091 County Center 

Drive, Suite 240, Auburn, CA 95603. 

(xxiv) Sacramento Metropolitan Air 

Quality Management District, 777 12th 

Street, Third Floor, Sacramento, CA 

95814–1908. 

(xxv) San Diego County Air Pollution 

Control District, 10124 Old Grove Road, 

San Diego, CA 92131–1649. 

(xxvi) San Joaquin Valley Air 

Pollution Control District, 1990 E. 

Gettysburg, Fresno, CA 93726. 

(xxvii) San Luis Obispo County Air 

Pollution Control District, 3433 Roberto 

Court, San Luis Obispo, CA 93401– 

7126. 

(xxviii) Santa Barbara County Air 

Pollution Control District, 260 North 

San Antonio Road, Suite A, Santa 

Barbara, CA 93110–1315. 

(xxix) Shasta County Air Quality 

Management District, 1855 Placer Street, 

Suite 101, Redding, CA 96001–1759. 

(xxx) Siskiyou County Air Pollution 

Control District, 525 So. Foothill Drive, 

Yreka, CA 96097–3036. 

(xxxi) South Coast Air Quality 

Management District, 21865 Copley 

Drive, Diamond Bar, CA 91765–4182. 

(xxxii) Tehama County Air Pollution 

Control District, P.O. Box 8069 (1750 

Walnut Street), Red Bluff, CA 96080– 

0038. 

(xxxiii) Tuolumne County Air 

Pollution Control District, 22365 

Airport, Columbia, CA 95310. 

(xxxiv) Ventura County Air Pollution 

Control District, 669 County Square 

Drive, 2nd Floor, Ventura, CA 93003– 

5417. 

(xxxv) Yolo-Solano Air Quality 

Management District, 1947 Galileo 

Court, Suite 103, Davis, CA 95616–4882. 

* * * * * 

(11) Hawaii. Clean Air Branch, Hawaii 

Department of Health, 919 Ala Moana 

Blvd., Suite 203, Honolulu, HI 96814. 

* * * * * 

(28) Nevada. Nevada Division of 

Environmental Protection, 901 South 

Stewart Street, Suite 4001, Carson City, 

NV 89701–5249. 

* * * * * 

PART 707—[AMENDED] 

■ 18. The authority citation for part 707 

continues to read as follows: 

Authority: 15 U.S.C. 2611(b) and 2612. 

Subpart B—General Import 

Requirements and Restrictions 

■ 19. Section 707.20 is amended by 

revising the address for Region IX in 

paragraph (c)(2)(ii) to read as follows: 

§ 707.20 Chemical substances import 

policy. 

* * * * * 

(c) * * * 

(2) * * * 

(ii) * * * 

Region IX 

75 Hawthorne Street, San Francisco, 

CA 94105 (415) 947–4402. 

* * * * * 

PART 763—[AMENDED] 

■ 20. The authority citation for part 763 

continues to read as follows: 

Authority: 15 U.S.C. 2605, 2607(c), 2643, 

and 2646. 

■ 21. Appendix C to Subpart E is 

amended by revising the address for 

EPA Region IX under II.C.3 to read as 

follows: 

Appendix C to Subpart E of Part 763— 

Asbestos Model Accreditation Plan 

* * * * * 

II. * * * 

C. * * * 

3. * * * 

EPA, Region IX, Asbestos NESHAPs Contact, 

Air Division (A–5), 75 Hawthorne Street, 

San Francisco, CA 94105, (415) 972–3989. 

* * * * * 

■ 22. Appendix D to Subpart E is 

amended by revising the address for 

Region IX to read as follows: 

Appendix D to Subpart E of Part 763— 

Transport and Disposal of Asbestos 

Waste 

* * * * * 

Region IX 

Asbestos NESHAPs Contact, Air Division, 

USEPA, Region IX, 75 Hawthorne Street, San 

Francisco, CA 94105, (415) 972–3989. 

* * * * * 

[FR Doc. 2010–28134 Filed 11–10–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0504; FRL–8845–6] 

Isoxaben; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of isoxaben in or 

on almond, hulls; grape; nut, tree, group 

14; and pistachio. Dow AgroSciences 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

November 12, 2010. Objections and 

requests for hearings must be received 

on or before January 11, 2011, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2007–0504. 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– 


jdjones on DSK8KYBLC1PROD with RULES
69354 Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Rules and Regulations 

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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

To access the harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2007–0504 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before January 11, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2007–0504, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of August 1, 

2007 (72 FR 42072) (FRL–8138–1), 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 7F7222) by Dow 

AgroSciences, 9330 Zionsville Road, 

Indianapolis, IN 46268. The petition 

requested that 40 CFR part 180 be 

amended by adding a section for the 

herbicide, isoxaben, and establishing 

tolerances therein for residues of 

isoxaben, N-[3-(1-ethyl-1-methylpropyl)- 

5-isoxazolyl]-2, 6-dimethoxybenzamide, 

in or on almond, hulls at 0.35 parts per 

million (ppm); grape; grape, juice; and 

grape, raisin at 0.01 ppm; and nut, tree, 

group 14 and pistachio at 0.03 ppm. 

That notice referenced a summary of the 

petition prepared by Dow AgroSciences, 

the registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

reduced the tolerances for nut, tree, 

group 14 and pistachio from 0.03 ppm 

to 0.02 ppm and increased the tolerance 

for almond, hulls from 0.35 ppm to 0.40 

ppm. EPA has also determined that the 

proposed tolerances for grape, juice and 

grape, raisin are not needed. Finally, 

EPA has revised the requested tolerance 

expression in accordance with current 

policy. The reasons for these changes 

are explained in Unit IV.C. 

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 isoxaben 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with isoxaben 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 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Rules and Regulations 69355 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Isoxaben is of low acute toxicity when 

administered orally, dermally, or via 

inhalation. It is not a dermal sensitizer 

or skin irritant and causes only minor 

transient irritation to the eye. 

The primary target organs identified 

for isoxaben in repeated-dose studies 

are the liver and kidney. Although liver 

effects were observed in all species 

tested (rat, dog, mouse), adverse changes 

were only observed in the mouse 

following chronic oral exposure. These 

effects included histopathology and 

increased blood alkaline phosphatase 

and alanine aminotransferase activities 

at high doses. In the dog and rat, liver 

effects were considered adaptive and 

consisted of enlargement, hepatocellular 

hypertrophy and induction of hepatic 

microsomal enzymes. Increased 

incidence and severity of nephropathy 

was observed in the rat following 

chronic (2-year) exposure. No adverse 

renal effects were reported in the dog or 

mouse. There was no indication of 

neurotoxicity or immunotoxicity in the 

available studies, which generally tested 

up to or above the limit dose. 

No maternal or developmental effects 

were seen in the rabbit or rat 

developmental studies. In the rat 

reproductive toxicity study, two matings 

(a and b generations) per F0 and F1 

parental generations were conducted, 

plus two additional matings (F2c and 

F3a) to examine developmental effects 

on gestation day 20. Effects included a 

decrease in corpora lutea, resulting in a 

decrease in the mean number of 

implantations and mean live fetuses per 

litter. Nursing pups showed decreased 

body weight gain at the highest dose 

tested. An increase in the incidence of 

several malformations (exencephaly, 

microphthalmia/coloboma and 

hydroureter) was seen in the F2b, F2c

and F3a mating generations at the limit 

dose of 1,000 milligrams/kilogram/day 

(mg/kg/day highest dose tested (HDT)), 

but not in the F1a, F1b or F2a offspring. 

The relationship of these findings to 

treatment is unclear because an 

examination of the genealogy of these 

offspring suggests a possible heritable 

component. A large percentage of the 

affected litters were the result of either 

cousin matings or had in common F0 

progenitors derived from several F0 

litters from the supplier. However, 

because the relationship to treatment 

could not be ruled out, the 

malformations were considered a 

possible treatment-related effect. 

No effects of treatment were reported 

in a 21-day repeated-application dermal 

toxicity study in the rabbit. This is 

consistent with relatively low dermal 

absorption (≤11% of administered dose) 

observed in a dermal penetration study 

in the monkey and the low oral toxicity 

observed in subchronic oral studies in 

the rat, mouse and dog. 

Isoxaben is classified as having 

‘‘Suggestive Evidence of Carcinogenic 

Potential’’ based on an increased 

incidence of benign liver tumors 

observed in male and female mice at the 

high dose only. EPA has concluded that 

the chronic risk assessment, based on 

the chronic RfD/PAD, is protective of 

potential carcinogenicity for the 

following reasons. The liver tumors 

were observed only in one species 

(mice), were not malignant, and were 

observed in the presence of liver 

toxicity at dietary levels exceeding the 

limit dose (1,000 mg/kg/day). The 

chronic RfD/PAD is based on the 

chronic toxicity NOAEL of 5 mg/kg/day 

in the rat, which is more than 200-fold 

lower than the dose at which tumors 

were observed in the mouse and, 

therefore, protective of potential 

carcinogenicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by isoxaben as well as the 

no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘Isoxaben. Human Health Risk 

Assessment for the First Food Uses of 

the Herbicide on Grapes, Tree Nuts and 

Pistachio’’ at page 50 in docket ID 

number EPA–HQ–OPP–2007–0504. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for isoxaben used for human 

risk assessment is shown in Table 1 of 

this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ISOXABEN FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario Point of departure and uncertainty/safety factors 

RfD, PAD, LOC for risk assessment Study and toxicological effects 

Acute dietary (All Populations, including Females 13–50 years of 

age, Infants and Children).

Not Applicable .............................. Not Applicable .............................. An appropriate endpoint was not 

identified that could occur following a single exposure. 

Chronic dietary (All populations) .... NOAEL= 5.0 mg/kg/day UFA = 

10x UFH = 10x FQPA SF = 1x.

Chronic RfD = 0.05 mg/kg/day 

cPAD = 0.05 mg/kg/day.

Chronic oral toxicity/carcinogenicity in the rat. LOAEL = 

50.7 mg/kg/day based on renal 

toxicity in males. 

Incidental oral short-term (1 to 30 

days).

Not Applicable .............................. Not Applicable .............................. An appropriate endpoint was not 

identified for short-term oral exposures. 


jdjones on DSK8KYBLC1PROD with RULES
69356 Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ISOXABEN FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario Point of departure and uncertainty/safety factors 

RfD, PAD, LOC for risk assessment Study and toxicological effects 

Incidental oral intermediate-term (1 

to 6 months).

NOAEL= 200 mg/kg/day UFA= 

10x.

UFH= 10x FQPA SF = 1x .............

LOC for MOE = 100 ..................... Reproductive toxicity in the rat 

(oral). Offspring LOAEL = 1,000 

mg/kg/day based on decreased 

body weight gain in F1 females 

on Day 70. 

One year dietary study in the rat 

(co-critical supporting study). 

LOAEL = 625 mg/kg/day based 

on decreased body weight gain 

in females during the first six 

months with a NOAEL of 62.5 

mg/kg/day. 

Dermal short-term (1 to 30 days) .. Not Applicable .............................. Not Applicable .............................. An appropriate endpoint was not 

identified for short-term dermal 

exposures. 

Dermal intermediate-term (1 to 6 

months).

Not Applicable .............................. Not Applicable .............................. An appropriate endpoint was not 

identified for intermediate-term 

dermal exposures. 

Inhalation short-term (1 to 30 

days).

Inhalation (or oral) study NOAEL= 

200 mg/kg/day (inhalation absorption rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... Reproductive toxicity in the rat 

(oral). LOAEL = 1,000 mg/kg/ 

day based on increased incidence of malformations. 

Inhalation intermediate-term (1 to 6 

months).

Inhalation (or oral) study NOAEL 

= 200 mg/kg/day (inhalation absorption rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... Reproductive toxicity in the rat 

(oral). LOAEL = 1,000 mg/kg/ 

day based on decreased body 

weight gain in F1 females on 

Day 70, decreased F2 pup 

weights, gestation survival and 

live pups/litter, and increased 

incidence of malformations. 

One year dietary study in the rat 

(co-critical supporting study). 

LOAEL = 625 mg/kg/day based 

on decreased body weight gain 

in females during the first six 

months with a NOAEL of 62.5 

mg/kg/day. 

Cancer (Oral, dermal, inhalation) .. Classification: Suggestive Evidence of Carcinogenic Potential, based on increased incidence of 

hepatocellular adenomas in male and female mice. The chronic risk assessment, based on the chronic 

RfD/PAD, is considered protective of potential carcinogenicity; a separate exposure assessment to evaluate 

cancer risk is unnecessary. 

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

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. LOAEL = lowest observed adverse effect level. NOAEL = no observed adverse effect 

level. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to isoxaben, EPA considered 

exposure under the petitioned-for 

tolerances. There are no tolerances 

currently established for isoxaben. EPA 

assessed dietary exposures from 

isoxaben 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 isoxaben; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

Continuing Surveys of Food Intakes by 

Individuals (CSFII). As to residue levels 

in food, EPA assumed that residues are 

present in all commodities at the 

tolerance level and that 100% of 

commodities are treated with isoxaben. 

DEEMTM 7.81 default concentration 

factors were used to estimate residues of 

isoxaben in processed commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA 

classified isoxaben as having 

‘‘Suggestive Evidence of Carcinogenic 

Potential’’ but determined that the 

chronic risk assessment will be 

protective of both non-cancer and 

cancer effects. Therefore, a separate 

exposure assessment to evaluate cancer 

risk is unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue or PCT 

information in the dietary assessment 

for isoxaben. Tolerance level residues 

and 100% CT were assumed for all food 

commodities. 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Rules and Regulations 69357 

2. Dietary exposure from drinking 

water. The residues of concern in 

drinking water following applications of 

isoxaben include isoxaben and its 

degradates hydroxyisoxaben (N-[3-(1- 

hydroxyl-1-methylpropyl)-5-isoxazoyl]- 

2,6-dimethoxy-benzamide); 

dimethoxybenzamide (2,6- 

dimethoxybenzamide); 

methoxyphenylpyrimidinol (6-(1-ethyl1-methylpropyl)-2-(2-hydroxy-6- 

methoxyphenyl)-4-pyrimidinol); and 

AEM hexenoylisoxaben (N-[3-amino-4- 

ethyl-4-methyl-2-hexenoyl]-2,6- 

dimethoxybenzamide). The Agency 

used screening level water exposure 

models in the dietary exposure analysis 

and risk assessment for isoxaben and its 

degradates in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of isoxaben and 

its degradates. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

isoxaben and its degradates for chronic 

exposures for non-cancer assessments 

(the only dietary exposure scenario of 

concern for isoxaben) are estimated to 

be 120 parts per billion (ppb) for surface 

water and 43.6 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 120 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). Isoxaben 

is currently registered for the following 

uses that could result in residential 

exposures: Home lawns, recreational 

turf areas and ornamental plantings. 

EPA assessed residential exposure using 

the following assumptions: There is a 

potential for exposure of homeowners 

applying products containing isoxaben 

on home lawns (i.e., residential handler 

exposure). There is also a potential for 

post-application exposure of adults and 

children entering lawn and recreation 

areas which have been treated with 

isoxaben and for bystander exposure of 

adults and children in areas adjacent to 

pesticide applications. 

For residential handlers, dermal and 

inhalation exposures of short-term 

duration are expected. Since EPA did 

not identify an endpoint of concern for 

dermal exposures, only short-term 

inhalation exposures were assessed. 

The following types of residential 

exposure may occur following 

applications of isoxaben on lawns and 

recreational turf areas: Short- and 

intermediate-term dermal and 

inhalation exposure of adults and 

children entering treated areas; shortterm incidental oral hand-to-mouth and/ 

or object-to-mouth exposure of children 

playing on treated turf; short- and 

intermediate-term incidental oral 

exposure of children ingesting soil from 

treated areas; and episodic oral 

exposure of children ingesting pesticide 

granules following applications of 

granular isoxaben formulations on 

lawns. Post-application inhalation 

exposures are expected to be negligible 

due to the low volatility of isoxaben, 

label recommendations for 

incorporation of the product (by rainfall 

or irrigation) after application, and the 

types of application equipment used to 

apply isoxaben (i.e., isoxaben is not 

applied using air blast or aerial 

equipment that would increase the 

potential for inhalation exposure). EPA 

did not identify an endpoint of concern 

for acute or short-term oral exposures or 

for short- or intermediate-term dermal 

exposures. Therefore, in its postapplication exposure assessment for 

isoxaben, EPA assessed only 

intermediate-term oral exposure of 

children ingesting treated soil. EPA does 

not typically consider soil ingestion to 

occur over intermediate-term durations, 

i.e., from 1–6 months, largely due to use 

patterns and the fact that residues are 

removed by precipitation or through 

microbial degradation in soil. In the 

case of isoxaben, the Agency estimated 

incidental oral exposure from ingestion 

of soil because the use pattern calls for 

repeat applications and the 

environmental fate data indicate that 

isoxaben is persistent in the soil. EPA 

conducted a conservative assessment of 

potential intermediate-term oral risk 

from soil ingestion using an application 

rate of 3.0 lb ai/A, equivalent to 3X the 

maximum single rate of 1.0 lb ai/A. The 

higher rate was assumed to account for 

build-up in the soil due to the 

pesticide’s persistence. 

Bystander exposure of adults and 

children is possible on areas adjacent to 

application sites. EPA’s concern for 

bystander exposures is low based on 

several considerations: 

i. Low acute toxicity of isoxaben via 

the inhalation route of exposure; 

ii. Label recommendations for 

incorporation of the product (by rainfall 

or irrigation) after application; 

iii. Isoxaben’s low volatility; and 

iv. The types of application 

equipment used to apply isoxaben (i.e., 

isoxaben is not applied using air blast 

or aerial equipment that would increase 

the potential for inhalation exposure). 

In addition, EPA notes that MOEs 

calculated for residential handlers of 

isoxaben are very high, ranging from 2.9 

million to 28 million (See Unit III.E.3.). 

Bystander exposures of both adults and 

children are expected to be substantially 

lower than residential handler 

exposures, resulting in even higher 

MOEs and lower risk for bystanders. For 

these reasons, EPA’s concern for 

bystander exposure of adults and 

children is low, and a quantitative 

assessment of bystander exposure and 

risk is considered unnecessary. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found isoxaben to share 

a common mechanism of toxicity with 

any other substances, and isoxaben does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

isoxaben does not have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 


jdjones on DSK8KYBLC1PROD with RULES
69358 Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Rules and Regulations 

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. 

The pre- and postnatal toxicity database 

for isoxaben includes guideline rat and 

rabbit developmental toxicity studies 

and a three-generation reproduction 

toxicity study in rats. There was no 

maternal or developmental toxicity 

observed in the developmental studies 

in rats and rabbits. Increased qualitative 

susceptibility was observed in the rat 

reproductive toxicity study as decreased 

live pups/litter and decreased gestation 

survival in F2b litters (relative to body 

weight effects in mothers). 

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 isoxaben is 

largely complete, missing only acute 

and subchronic neurotoxicity studies, 

an immunotoxicity study and a 

subchronic inhalation study. EPA has 

determined that an additional 

uncertainty factor is not needed to 

account for the lack of these studies for 

the following reasons: 

• There is no evidence in the existing 

studies that isoxaben targets either the 

nervous system or the immune system. 

• EPA’s concern for inhalation 

toxicity from subchronic exposures is 

low, based on isoxaben’s low vapor 

pressure and frequency of application. 

• Overall, the toxicity of isoxaben is 

low. The available oral studies of shortterm (e.g., developmental toxicity) or 

subchronic exposure duration indicated 

no toxicity up to the limit dose. Effects 

observed in adult animals (decreased 

body weight) at exposures of 

intermediate-term duration were 

minimal, and malformations seen in 

offspring in the rat reproduction study 

were of uncertain relationship to 

treatment. The endpoints were assumed 

by EPA to be treatment-related, a 

conservative assumption intended to 

ensure the risk assessment is protective 

of potential effects. 

Based on these considerations, EPA 

does not expect the required studies to 

provide lower points of departure than 

those currently selected for risk 

assessment, and an additional 

uncertainty factor is not needed to 

account for the lack of these studies. 

ii. There is no evidence of 

neurotoxicity in the available toxicology 

database and no evidence of 

developmental toxicity in either the rat 

or rabbit developmental toxicity studies 

at doses up to the limit dose. Based on 

these considerations, there is no need 

for a developmental neurotoxicity study 

or additional UFs to account for 

neurotoxicity. 

iii. There was no evidence of 

increased susceptibility in the rat and 

rabbit developmental toxicity studies. 

Although increased qualitative 

susceptibility was observed in the rat 

reproductive toxicity study as decreased 

live pups/litter and decreased gestation 

survival in F2b litters (relative to body 

weight effects in mothers), EPA’s 

concern for qualitative susceptibility is 

low. Offspring effects were seen only at 

the limit dose in later generations and 

not observed in the developmental 

studies. Additionally, since there is 

evidence that observed malformations 

were due in part to heritable factors, the 

relationship of these effects to treatment 

is unclear. There are low concerns for 

effects on offspring viability, because 

they were only observed at the limit 

dose and may have been secondary to 

effects on the dams. The endpoints and 

points of departure selected for risk 

assessment are protective of these 

effects. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed assuming tolerancelevel residues and 100% crop treated for 

all commodities. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to isoxaben in 

drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by isoxaben. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, isoxaben 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 isoxaben from 

food and water will utilize 17% of the 

cPAD for infants, less than 1 year old, 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

isoxaben 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). Isoxaben is currently 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

isoxaben. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in an 

aggregate MOE of 82,000 for adults. The 

MOE for adults includes chronic 

exposure from food and water plus 

short-term residential handler exposure 

of adult females, based on the worstcase granular push-type applicator 

scenario. Because EPA’s level of 

concern for isoxaben is a MOE of 100 or 

below, this MOE is not of concern. For 

children, no short-term oral or dermal 

endpoints of concern were identified, 

and residential post-application 

inhalation exposure is expected to be 

negligible. Therefore, EPA relies on the 

chronic dietary risk assessment 

discussed in Unit III.E.2. for evaluating 

children’s short-term risk from 

isoxaben. 

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). 

Isoxaben is currently registered for uses 

that could result in intermediate-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with intermediate-term 

residential exposures to isoxaben. 

Using the exposure assumptions 

described in this unit for intermediateVerDate Mar<15>2010 15:36 Nov 10, 2010 Jkt 223001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\FR\FM\12NOR1.SGM 12NOR1

jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Rules and Regulations 69359 

term exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in an aggregate MOE of 51,000 for 

children. The MOE for children 

includes chronic exposure from food 

and water plus intermediate-term oral 

exposure of children ingesting treated 

soil. Because EPA’s level of concern for 

isoxaben is a MOE of 100 or below, the 

MOE for children is not of concern. For 

adults, no intermediate-term dermal 

endpoint of concern was identified, and 

residential post-application inhalation 

exposure is expected to be negligible. 

Therefore, EPA relies on the chronic 

dietary risk assessment discussed in 

Unit III.E.2. for evaluating adults’ 

intermediate-term risk from isoxaben. 

5. Aggregate cancer risk for U.S. 

population. As explained in Unit III.A., 

risk assessments based on the endpoint 

selected for chronic risk assessment are 

considered to be protective of any 

potential carcinogenic risk from 

exposure to isoxaben. Based on the 

results of the chronic risk assessment 

discussed above in Unit III.E.2., EPA 

concludes that isoxaben is not expected 

to pose a cancer risk. 

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 isoxaben 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high-performance liquid 

chromatography with tandem mass 

spectromectric detection (LC/MS/MS), 

method GRM 02.26.S.1) is available to 

enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for isoxaben. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the maximum residue of 

0.015 ppm observed in field trials with 

almonds and pecans, the proposed 

tolerances for nut, tree, group 14 and 

pistachio were reduced from 0.03 ppm 

to 0.02 ppm. The proposed tolerance for 

almond hulls was increased from 0.35 

ppm to 0.40 ppm based on analysis of 

the field trial data using the Agency’s 

Tolerance Spreadsheet in accordance 

with the ‘‘Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data.’’ 

EPA has also determined that, since the 

tolerance for grape will cover residues 

in/on grape juice and raisins, separate 

tolerances are not needed for these 

commodities. 

Finally, EPA is revising the requested 

tolerance expression to clarify the 

chemical moieties that are covered by 

the tolerances and specify how 

compliance with the tolerances is to be 

measured. The revised tolerance 

expression makes clear that the 

tolerances cover residues of the 

herbicide isoxaben, including its 

metabolites and degradates, but that 

compliance with the specified tolerance 

levels is to be determined by measuring 

only isoxaben N-[3-(1-ethyl-1- 

methylpropyl)-5-isoxazolyl]-2, 6- 

dimethoxybenzamide, in or on the 

commodities. 

V. Conclusion 

Therefore, tolerances are established 

for residues of isoxaben, including its 

metabolites and degradates, in or on 

almond, hulls at 0.40 ppm; grape at 0.01 

ppm; nut, tree, group 14 at 0.02 ppm; 

and pistachio at 0.02 ppm. Compliance 

with these tolerances is to be 

determined by measuring only isoxaben 

N-[3-(1-ethyl-1-methylpropyl)-5- 

isoxazolyl]-2, 6-dimethoxybenzamide, 

in or on the commodities. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

et seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 

et seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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


jdjones on DSK8KYBLC1PROD with RULES
69360 Federal Register / Vol. 75, No. 218 / Friday, November 12, 2010 / Rules and Regulations 

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: October 29, 2010. 

Steven Bradbury, 

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. Add § 180.650 to subpart C to read 

as follows: 

§ 180.650 Isoxaben; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

isoxaben, including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only isoxaben, 

N-[3-(1-ethyl-1-methylpropyl)-5- 

isoxazolyl]-2, 6-dimethoxybenzamide, 

in or on the commodity. 

Commodity Parts per 

million 

Almond, hulls ........................ 0.40 

Grape .................................... 0.01 

Nut, tree, Group 14 .............. 0.02 

Pistachio ............................... 0.02 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2010–28499 Filed 11–10–10; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Parts 216 and 252 

Defense Federal Acquisition 

Regulation Supplement; Award-Fee 

Reductions for Health and Safety 

Issues (DFARS Case 2009–D039) 

AGENCY: Defense Acquisition 

Regulations System; Department of 

Defense (DoD). 

ACTION: Interim rule with request for 

comments. 

SUMMARY: DoD is issuing an interim rule 

amending the Defense Federal 

Acquisition Regulation Supplement 

(DFARS) to implement section 823 of 

the National Defense Authorization Act 

for Fiscal Year 2010. Section 823 

requires contracting officers to consider 

reduction or denial of award fee if 

contractor or subcontractor actions 

jeopardize the health or safety of 

Government personnel. 

DATES: Effective Date: November 12, 

2010. 

Comment Date: Comments on the 

interim rule should be submitted to the 

address shown below on or before 

January 11, 2011, to be considered in 

the formation of the final rule. 

ADDRESSES: You may submit comments, 

identified by DFARS Case 2009–D039, 

using any of the following methods: 

Æ Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Æ E-mail: dfars@osd.mil. Include 

DFARS Case 2009–D039 in the subject 

line of the message. 

Æ Fax: 703–602–0350. 

Æ Mail: Defense Acquisition 

Regulations Council, Attn: Ms. Amy G. 

Williams, OUSD (AT&L) DPAP (DARS), 

Room 3B855, 3060 Defense Pentagon, 

Washington, DC 20301–3060. 

Comments received generally will be 

posted without change to http:// 

www.regulations.gov, including any 

personal information provided. To 

confirm receipt of your comment, please 

check http://www.regulations.gov 

approximately two to three days after 

submission to verify posting (except 

allow 30 days for posting of comments 

submitted by mail). 

FOR FURTHER INFORMATION CONTACT: Ms. 

Amy G. Williams, 703–602–0328. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 823 of the National Defense 

Authorization Act for Fiscal Year 2010 

(Pub. L. 111–84), requires DoD to revise 

guidance issued pursuant to section 814 

of the National Defense Authorization 

Act for Fiscal Year 2007 (Pub. L. 109– 

364). Section 823 is entitled ‘‘Authority 

for Secretary of Defense to Reduce or 

Deny Award Fees to Companies Found 

to Jeopardize Health or Safety of 

Government Personnel.’’ For covered 

contracts that include award fees, if a 

contractor or its subcontractor acts with 

gross negligence or reckless disregard 

for health or safety, causing serious 

bodily injury or death of Government 

personnel, then the contracting officer 

must consider reduction or denial of 

award fee for the period in which that 

action occurred. This interim rule 

provides a clause to detail those 

dispositions where a reduction or denial 

of award fee is applicable. The clause 

also allows for the recovery of all or part 

of any award fees paid for any previous 

award fee evaluation period during 

which contractor actions caused serious 

bodily injury or death of Government 

personnel. 

II. Executive Order 12866 

This is not a significant regulatory 

action and, therefore, was not subject to 

review under section 6(b) of Executive 

Order 12866, Regulatory Planning and 

Review, dated September 30, 1993. 

III. Regulatory Flexibility Act: 

DoD does not expect this interim rule 

to 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 most contracts awarded to 

small entities use simplified acquisition 

procedures or, based on the 

circumstances, may be awarded on a 

competitive fixed-price basis or a costplus-fixed-fee basis. Contracts awarded 

to small businesses do not generally 

utilize award-fee type incentive fee 

structure. Therefore, DoD has not 

performed an initial regulatory 

flexibility analysis. DoD invites 

comments from small business concerns 

and other interested parties on the 

expected impact of this rule on small 

entities. 

DoD will also consider comments 

from small entities concerning the 

existing regulations in subparts affected 

by this rule in accordance with 5 U.S.C. 

610. Interested parties must submit such 

comments separately and should cite 5 

U.S.C. 610 (DFARS Case 2009–D039) in 

correspondence. 

IV. Paperwork Reduction Act 

The Paperwork Reduction Act does 

not apply because the rule does not 

impose any information collection 

requirements that require the approval 


jdjones on DSK8KYBLC1PROD with RULES