26662 Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 

2008); 2271, ‘‘Variances’’ (operative 

August 29, 2008); 2273, ‘‘Labeling of 

Equipment Dispensing Gasoline 

Containing MTBE’’ (operative August 

29, 2008). 

(2) ‘‘California Procedures for 

Evaluating Alternative Specifications for 

Phase 3 Reformulated Gasoline Using 

the California Predictive Model,’’ as last 

amended August 7, 2008. 

(3) ‘‘Procedures for Using the 

California Model for California 

Reformulated Gasoline Blendstocks for 

Oxygenate Blending (CARBOB),’’ as last 

amended August 7, 2008. 

(ii) Additional material. 

(A) California Air Resources Board. 

(1) Executive Order S–09–001, dated 

February 3, 2009, adopting the 2009 

RFG Revision. 

(376) The following revisions to the 

California Diesel Fuel Regulations were 

submitted on February 3, 2009 (2009 

Diesel Fuels Revision), by the 

Governor’s Designee. 

(i) Incorporation by reference. 

(A) California Air Resources Board. 

(1) Title 13, California Code of 

Regulations, Division 3 (Air Resources 

Board), Chapter 1 (Motor Vehicle 

Pollution Control Devices), Article 1 

(General Provisions), sections 1956.8, 

‘‘Exhaust Emissions Standards and Test 

Procedures—1985 and Subsequent 

Model Heavy-Duty Engines and 

Vehicles’’ (operative December 31, 

2008); 1960.1, ‘‘Exhaust Emissions 

Standards and Test Procedures—1981 

through 2006 Model Passenger Cars, 

Light-Duty and Medium-Duty Vehicles’’ 

(operative March 26, 2004); 1961, 

‘‘Exhaust Emissions Standards and Test 

Procedures—2004 and Subsequent 

Model Passenger Cars, Light-Duty and 

Medium-Duty Vehicles’’ (operative June 

16, 2008); Chapter 5 (Standards for 

Motor Vehicle Fuels), Article 2 

(Standards for Diesel Fuel), sections 

2281, ‘‘Sulfur Content of Diesel Fuel’’ 

(operative August 4, 2005); 2282, 

‘‘Aromatic Hydrocarbon Content of 

Diesel Fuel’’ (operative August 4, 2005); 

2284, ‘‘Lubricity of Diesel Fuel’’ 

(operative August 4, 2005); 2285, 

‘‘Exemption from Diesel Fuel 

Requirements for Military-Specification 

Fuels Used in Qualifying Military 

Vehicles’’ (operative August 14, 2004); 

Chapter 14 (Verification Procedure, 

Warranty and In-Use Compliance 

Requirements for In-Use Strategies to 

Control Emissions from Diesel Engines), 

section 2701, ‘‘Definitions’’ (operative 

January 1, 2005). 

(2) Title 17, California Code of 

Regulations, Division 3 (Air Resources), 

Chapter 1 (Air Resources Board), 

Subchapter 7.5 (Airborne Toxic Control 

Measures), section 93114, ‘‘Airborne 

Toxic Control Measure To Reduce 

Particulate Emissions from DieselFueled Engines—Standards for 

Nonvehicular Diesel Fuel’’ (operative 

August 14, 2004). 

(ii) Additional material. 

(A) California Air Resources Board. 

(1) Executive Order S–09–001, dated 

February 3, 2009, adopting the 2009 

Diesel Fuels Revision. 

* * * * * 

[FR Doc. 2010–11005 Filed 5–11–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0032; FRL–8824–5] 

Fluazinam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluazinam in 

or on bushberry subgroup 13-07B; 

onion, bulb, subgroup 3-07A; lettuce, 

head; and lettuce, leaf. This regulation 

additionally removes several established 

individual commodities and bushberry 

subgroup 13B, as they will be 

superseded by inclusion in bushberry 

subgroup 13-07B. Interregional Research 

Project Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

12, 2010. Objections and requests for 

hearings must be received on or before 

July 12, 2010, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0032. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; e-mail address: 

nollen.laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

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. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

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objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0032 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 July 12, 2010. 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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0032, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of April 8, 

2009 (74 FR 15971) (FRL–8407–4), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 8E7506) by IR-4, 

500 College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.574 be 

amended by establishing tolerances for 

residues of the fungicide fluazinam, (3- 

chloro- N -[3-chloro-2,6-dinitro-4- 

(trifluoromethyl) phenyl]-5- 

(trifluoromethyl)-2-pyridinamine), in or 

on lettuce, head at 0.02 parts per million 

(ppm); lettuce, leaf at 2.0 ppm; onion, 

bulb, subgroup 3-07A at 0.15 ppm; and 

bushberry subgroup 13-07B at 4.5 ppm. 

The petition additionally requested to 

remove the established tolerances in or 

on aronia berry, buffalo currant, Chilean 

guava, European barberry, highbush 

cranberry, edible honeysuckle, 

jostaberry, Juneberry, lingonberry, 

native currant, salal, sea buckthorn, and 

bushberry subgroup 13B at 7.0 ppm. 

The published notice of the petition 

referenced a summary of the petition 

prepared on behalf of IR-4 by ISK 

Biosciences, the registrant, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerances for bushberry 

subgroup 13-07B and onion, bulb, 

subgroup 3-07A. EPA has also revised 

the tolerance expression for all 

established commodities to be 

consistent with current Agency 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 fluazinam 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluazinam 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. 

Following subchronic and chronic 

exposure to fluazinam, the liver 

appeared to be a primary target organ in 

rats, dogs, and mice. Signs of liver 

toxicity included changes in clinical 

chemistry (increased serum alkaline 

phosphatase and aspartate 

aminotransferase), increased absolute 

and/or relative liver weights, increased 

incidences of gross lesions (pale, 

enlarged, pitted, mottled, accentuated 

markings), and a variety of 

histopathological lesions. Treatmentrelated effects were also observed in 

other organs following subchronic and 

chronic exposure to fluazinam, but 

these effects were not consistently noted 

in all three species or in all studies in 

a given species. 

In a developmental toxicity study in 

rats, fetal effects included decreases in 

body and placental weights, increased 

incidences of facial/palate clefts, 

diaphragmatic hernias, delayed 

ossification in several bone types, 

increases in late resorptions, as well as 

evidence of a greenish amniotic fluid 

and postimplantation loss. Maternal 

effects, including decreases in body 

weight gain/food consumption and 

increases in water consumption and 

urogenital staining, were observed at the 

same dose level. In the rat 

developmental neurotoxicity (DNT) 

study, effects in pups (including 

decreases in body weight/body weight 

gain and delayed preputial separation) 

were noted in the absence of maternal 

toxicity. 

In an acute neurotoxicity study in 

rats, effects included decreases in motor 

activity and soft stools; these effects 

were considered to be due to systemic 

toxicity and not a result of frank 

neurotoxicity. No signs of neurotoxicity 

were observed in two subchronic 

neurotoxicity studies in rat up to the 

highest dose tested (HDT). A neurotoxic 

lesion described as vacuolation of the 

white matter of the central nervous 

system was observed in subchronic and 

chronic studies in mice and dogs; 

however, this lesion was found to be 

reversible and is attributed to an 

impurity (impurity 5). Based on the 

level of this impurity in technical grade 

fluazinam, the risk assessment for the 

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parent compound is considered 

protective of the effects noted. 

In a rat carcinogenicity study, there 

was some evidence that fluazinam 

induced an increase in thyroid gland 

follicular cell tumors in male rats. In 

one mouse carcinogenicity study, clear 

evidence of a treatment-related increase 

of hepatocellular tumors was observed 

in male mice; in another mouse 

carcinogenicity study, there was 

equivocal evidence that fluazinam may 

have induced an increase in 

hepatocellular tumors in male mice. 

There was no evidence of statisticallysignificant tumor increases in female 

mice or rats in any study and no 

evidence of mutagenic activity in the 

submitted mutagenicity studies for 

fluazinam. EPA has classified fluazinam 

as having suggestive evidence of 

carcinogenicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluazinam 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 document 

‘‘Fluazinam. Human Health Risk 

Assessment for the Proposed Uses on 

Apples, Carrots, Lettuce, and the Bulb 

Onion Subgroup (3-07A), and a Request 

for a Reduced Tolerance on the 

Bushberry Subgroup (13-07B),’’ pp. 60– 

65 in docket ID number EPA–HQ–OPP– 

2009–0032. 

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 fluazinam used for human 

risk assessment is shown in the table of 

this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUAZINAM FOR USE IN HUMAN RISK ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects 

Acute dietary 

(Females 13–49 years of 

age) 

NOAEL = 7milligrams/kilogram/day (mg/kg/day) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.07 mg/kg/day 

aPAD = 0.07 mg/kg/day 

Developmental Toxicity Study-Rabbits 

LOAEL = 12 mg/kg/day based on increased incidence of total litter resorptions and possible increased incidence of fetal skeletal abnormalities. 

Acute dietary 

(General population including 

infants and children) 

NOAEL = 50 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF =1x 

Acute RfD = 0.5 mg/kg/day 

aPAD = 0.5 mg/kg/day 

Acute Neurotoxicity-Rats 

LOAEL = 1,000 mg/kg/day based on 

decreased motor activity and soft 

stools on day of dosing. 

Chronic dietary 

(All populations) 

NOAEL = 1.1 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.011 mg/kg/day 

cPAD = 0.011 mg/kg/day 

Carcinogenicity-Mice 

LOAEL = 10.7 mg/kg/day based on 

liver histopathology and increased 

liver weight. 

Cancer 

(Oral, dermal, inhalation) 

Classification: Suggestive Evidence of Carcinogenicity. The cRfD is protective of cancer effects. 

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

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose 

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

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluazinam, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

fluazinam tolerances in 40 CFR 180.574. 

EPA assessed dietary exposures from 

fluazinam 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. Such effects were identified 

for fluazinam. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA utilized 

tolerance-level residues and assumed 

100 percent crop treated (PCT) for all 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

utilized tolerance-level residues for all 

commodities except apple (for which 

the average field trial residue value was 

used) and assumed 100 PCT for all 

commodities. 

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iii. Cancer. Fluazinam has been 

classified as having suggestive evidence 

of carcinogenicity. This determination is 

based on weight of evidence 

considerations where a concern for 

potential carcinogenic effects in humans 

is raised, but the animal data are judged 

not sufficient for a stronger conclusion. 

Carcinogenicity studies were 

conducted in rats and mice. In rats, 

increased incidences of thyroid gland 

follicular cell tumors were seen in males 

but not in females. In mice, there were 

conflicting results with regard to 

hepatocarcinogenicity. In one study, 

benign and malignant liver tumors were 

seen in males; no liver tumors were seen 

in females. In the second study, 

carcinogenic response was equivocal 

and tumors did not occur in a doserelated manner. In males, the dose that 

induced liver tumors in the first study 

failed to induce liver tumors in the same 

strain of mice in the second study. In 

the second study, in females, liver 

tumors were seen only at an excessive 

toxic dose. There was no evidence of 

mutagenicity either in in vivo or in vitro 

assays. No chemicals structurally 

related to fluazinam were identified as 

carcinogens. 

Since the evidence for carcinogenicity 

is not sufficient to indicate anything 

greater than a suggestion of a 

carcinogenic potential, EPA concludes 

that quantification of cancer risk would 

not be scientifically appropriate, as it 

attaches greater significance to the 

positive cancer findings than the entire 

dataset warrants. Further, due to the 

equivocal and inconsistent nature of the 

cancer response in the rat and mouse 

studies (in rats, effects seen only in 

males; in mice, one study showed 

effects only in males but even these 

effects were not reproducible), EPA 

finds that when judged qualitatively the 

data indicate no greater than a negligible 

risk of cancer. The Agency has 

determined that the POD (1.1 mg/kg/ 

day) selected for deriving the cRfD is 

protective of all chronic effects, 

including the equivocal cancer effects; 

therefore, the chronic dietary exposure 

assessment was relied upon for 

assessing cancer risk. 

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 section 408(f)(1) of 

FFDCA 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 CallIns as are required by section 

408(b)(2)(E) of FFDCA and authorized 

under section 408(f)(1) of FFDCA. 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 residues of concern in 

drinking water for risk assessment are 

parent fluazinam and its degradates, 

including DCPA, CAPA, DAPA, and 

HYPA. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fluazinam and its degradates in 

drinking water. These simulation 

models take into account data on the 

physical, chemical, and fate/transport 

characteristics of fluazinam 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 (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

fluazinam and its degradates for surface 

water are estimated to be 117 parts per 

billion (ppb) for acute exposures and 

19.8 ppb for chronic exposures. For 

ground water, the EDWCs are estimated 

to be 0.216 ppb for both acute and 

chronic exposures. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. The 

water concentration values of 117 ppb 

and 19.8 ppb were used to assess the 

contribution to drinking water in the 

acute and chronic dietary risk 

assessments, respectively. 

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). Fluazinam 

is not registered for any specific use 

patterns that would result in residential 

exposure. 

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 fluazinam to share 

a common mechanism of toxicity with 

any other substances, and fluazinam 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that fluazinam does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

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

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (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 prenatal and postnatal toxicology 

database for fluazinam includes rat and 

rabbit prenatal developmental toxicity 

studies, a 2–generation reproductive 

toxicity study in rats, and a DNT study 

in rats. There was no evidence of 

increased quantitative or qualitative 

susceptibility in the rabbit 

developmental toxicity study or the rat 

2–generation reproductive toxicity 

study; however, evidence of increased 

qualitative susceptibility of fetuses was 

observed in the rat developmental 

toxicity study and evidence of increased 

quantitative susceptibility of fetuses was 

observed in the rat DNT study. 

In the developmental toxicity study in 

rats, fetal effects (increased incidences 

of facial/palate clefts and other rare 

deformities in the fetuses) were 

observed in the presence of minimal 

maternal toxicity (decreased body 

weight gain and food consumption, and 

increased water consumption and 

urogenital staining). In the rat DNT 

study, decreases in body weight/body 

weight gain and a delay in completion 

of balano-preputial separation were 

observed in pups in the absence of 

maternal effects, suggesting increased 

quantitative susceptibility of the 

offspring. 

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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 fluazinam 

is complete, except for immunotoxicity 

testing. Recent changes to 40 CFR part 

158 make immunotoxicity testing 

(Harmonized Guideline 870.7800) 

required for pesticide registration; 

however, the existing data are sufficient 

for endpoint selection for exposure/risk 

assessment scenarios, and for evaluation 

of the requirements under the FQPA. 

The available data for fluazinam show 

no evidence of treatment-related effects 

on the immune system, and the Agency 

does not believe that conducting an 

immunotoxicity study will result in a 

lower POD than that currently selected 

for overall risk assessment. Therefore, 

an additional database uncertainty 

factor to account for potential 

immunotoxicity does not need to be 

applied. 

ii. A DNT study in rat is available and 

shows evidence of increased 

quantitative susceptibility of offspring. 

Although the NOAEL for this study (2 

mg/kg/day) is lower than that used for 

the aRfD for females 13-49 (7 mg/kg/ 

day), the effects noted in the DNT study 

are considered to be postnatal effects 

attributable to multiple doses; therefore, 

the study endpoint is not appropriate 

for acute dietary exposures. The cRfD 

(0.011 mg/kg/day) is based on a lower 

NOAEL (1.1 mg/kg/day), and is 

considered to be protective of potential 

developmental effects. Therefore, the 

degree of concern is low for the 

observed effects and there are no 

residual uncertainties with regard to 

prenatal and/or postnatal neurotoxicity. 

iii. Although there is qualitative 

evidence of increased susceptibility 

following in utero exposure to 

fluazinam in the rat developmental 

toxicity study, the degree of concern for 

the observed effects is low. Fetal effects 

were observed only at the HDT and in 

the presence of maternal toxicity, and 

there is a clear NOAEL for the fetal 

effects seen. Additionally, the NOAEL 

(50 mg/kg/day) identified in the 

developmental toxicity study in rats is 

significantly higher than the NOAEL 

used (7 mg/kg/day) to establish the aRfD 

for females 13-49. Therefore, the aRfD is 

protective of any potential 

developmental effects and there are no 

residual uncertainties for prenatal and/ 

or postnatal toxicity. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute and chronic dietary food 

exposure assessments were performed 

based on 100 PCT for all commodities. 

Additionally, the acute assessment is 

based on tolerance level residues for all 

commodities, and the chronic 

assessment is based on tolerance level 

residues for all commodities except 

apple (for which the average field trial 

value was used). These assumptions 

result in high-end estimates of dietary 

exposure. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to fluazinam in 

drinking water. Fluazinam is not 

registered for any specific use patterns 

that would result in residential 

exposure. These assessments will not 

underestimate the exposure and risks 

posed by fluazinam. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fluazinam will occupy 20% of the aPAD 

for females 13-49 years old and 20% of 

the aPAD for children 1-2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fluazinam from 

food and water will utilize 40% of the 

cPAD for all infants less than 1 year old, 

the population group receiving the 

greatest exposure. There are no 

residential uses for fluazinam. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposures takes into account short- and 

intermediate-term residential exposures 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Short- and 

intermediate-term adverse effects were 

identified; however, fluazinam is not 

registered for any use patterns that 

would result in short- or intermediateterm residential exposures. Short- and 

intermediate-term risk is assessed based 

on short- and intermediate-term 

residential exposures plus chronic 

dietary exposure. Because there are no 

short- or intermediate-term residential 

exposures and chronic dietary exposure 

has already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess short-term risk), no further 

assessment of short- or intermediateterm risk is necessary, and EPA relies on 

the chronic dietary risk assessment for 

evaluating short- and intermediate-term 

risk for fluazinam. 

4. Aggregate cancer risk for U.S. 

population. Based on the discussion in 

Unit III.A., EPA has concluded that the 

cPAD is protective of possible cancer 

effects. Because chronic exposure is 

20% of the cPAD for the most highly 

exposed population subgroups, cancer 

risk resulting from exposure to 

fluazinam is not of concern. 

5. 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 fluazinam 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement 

methodology, gas chromatography with 

electron capture detection (GC/ECD), is 

available to enforce the tolerance 

expression for crop matrices. A high 

performance liquid chromatography 

with ultraviolet detection (HPLC/UV) 

enforcement method is also available to 

enforce the tolerance expression for 

wine grapes, which includes residues of 

the metabolite AMGT. These methods 

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 

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Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 26667 

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. 

There are currently no Codex or 

Mexican MRLs established for residues 

of fluazinam in or on the commodities 

associated with this petition. However, 

Canada has an approved MRL for the 

use of fluazinam on bushberry subgroup 

13B at 7.0 ppm, which is based on an 

earlier joint review effort between the 

Canadian Pesticide Management 

Regulatory Agency (PMRA) and EPA. 

C. Revisions to Petitioned-For 

Tolerances 

Based on analysis of the data 

supporting the petition, EPA has revised 

the proposed tolerance for onion, bulb, 

subgroup 3-07A from 0.15 ppm to 0.20 

ppm. EPA revised this tolerance level 

based on analysis of the residue field 

trial data using the Agency’s Tolerance 

Spreadsheet in accordance with the 

Agency’s Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data. 

EPA has also revised the tolerance 

expression to clarify: 

1. That, as provided in section 

408(a)(3) of FFDCA, the tolerance covers 

metabolites and degradates of fluazinam 

not specifically mentioned; and 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

Additionally, the Agency has revised 

the proposed tolerance for bushberry 

subgroup 13-07B from 4.5 ppm to 7.0 

ppm. Permanent tolerances exist for 

residues of fluazinam in or on bushberry 

subgroup 13B and several individual 

bushberry commodities (aronia berry, 

buffalo currant, Chilean guava, 

European barberry, highbush cranberry, 

edible honeysuckle, jostaberry, 

juneberry, lingonberry, native currant, 

salal, and sea buckthorn) at 7.0 ppm. IR4 petitioned the Agency to establish a 

tolerance for the revised bushberry 

subgroup 13-07B at 4.5 ppm, which 

would supersede the tolerances for both 

bushberry subgroup 13B and the 

individual bushberry tolerances. After 

reevaluating the existing data in support 

of the bushberry subgroup 13-07B 

tolerance in accordance with the 

Agency’s Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data, 

EPA has determined that the probability 

plot for the residue data are lognormally 

distributed and that the bushberry 

subgroup 13-07B tolerance should be 

established at 7.0 ppm. The revised 

tolerance for bushberry subgroup 13- 

07B at 7.0 ppm is equivalent to the 

existing tolerances for the individual 

bushberry commodities and bushberry 

subgroup 13B. Further, the 7.0 ppm 

tolerance on bushberry harmonizes with 

a MRL established in Canada, as 

discussed in Unit IV.B. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluazinam, (3-chloro-N- 

[3-chloro-2,6-dinitro-4- 

(trifluoromethyl)phenyl]-5- 

(trifluoromethyl)-2-pyridinamine), in or 

on bushberry subgroup 13-07B at 7.0 

ppm; lettuce, head at 0.02 ppm; lettuce, 

leaf at 2.0 ppm; and onion, bulb, 

subgroup 3-07A at 0.20 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 4, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.574 is amended as 

follows: 

■ 

■ i. Revise the introductory text of 

paragraph (a)(1); 

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26668 Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 

■ ii. Remove the entries for ‘‘Aronia 

berry’’; ‘‘Buffalo currant’’; ‘‘Bushberry 

subgroup 13B’’; ‘‘Chilean guava’’; 

‘‘European barberry’’; ‘‘Highbush 

cranberry’’; ‘‘Honeysuckle, edible’’; 

‘‘Jostaberry’’; ‘‘Juneberry’’; ‘‘Lingonberry’’; 

‘‘Native currant’’; ‘‘Salal’’; and ‘‘Sea 

buckthorn’’ from the table in paragraph 

(a)(1); 

■ iii. Alphabetically add commodities to 

the table in paragraph (a)(1); and 

■ iv. Revise the introductory text of 

paragraph (a)(2). 

The amendments read as follows: 

§ 180.574 Fluazinam; tolerances for 

residues. 

(a) * * * (1) Tolerances are established 

for residues of fluazinam (3-chloro-N-[3- 

chloro-2,6-dinitro-4- 

(trifluoromethyl)phenyl]-5- 

(trifluoromethyl)-2-pyridinamine), 

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 

fluazinam. 

Commodity Parts per million 

Bushberry subgroup 13- 

07B .............................. 7.0 

* * * * * 

Lettuce, head .................. 0.02 

Lettuce, leaf .................... 2.0 

Onion, bulb, subgroup 3- 

07A .............................. 0.20 

* * * * * 

(2) Tolerances are established for 

residues of fluazinam, 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 fluazinam and its 

metabolite AMGT (3-[[4-amino-3-[[3- 

chloro-5-(trifluoromethyl)-2- 

pyridinyl]amino]-2-nitro-6- 

(trifluoromethyl) phenyl]thio]-2-(beta-Dglucopyranosyloxy) propionic acid). 

* * * * * 

[FR Doc. 2010–11302 Filed 5–11–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0184; FRL–8812–6] 

Flutriafol; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of flutriafol, [(±)- 

a-(2-fluorophenyl)-a-(4-fluorophenyl)- 

1H-1,2,4-triazole-1-ethanol], including 

its metabolites and degradates in or on 

apple at 0.20 ppm; soybean, seed at 0.35 

ppm; and grain, aspirated fractions at 

2.2 ppm; and cattle, goat, hog, horse and 

sheep liver at 0.02 ppm. Cheminova A/ 

S, c/o Cheminova, Inc. requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

12, 2010. Objections and requests for 

hearings must be received on or before 

July 12, 2010, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0184. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Tamue L. Gibson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–9096; e-mail address: 

gibson.tamue@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

To access the OPPTS Harmonized Test 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gov/opptsfrs/home/ 

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0184 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 July 12, 2010. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

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