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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Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 26669 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0184, 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 15973) (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 7F7197) by 

Cheminova A/S, c/o Cheminova, Inc., 

1600 Wilson Blvd., Arlington, VA 

22209. The petition requested that 40 

CFR 180 be amended by establishing 

tolerances for residues of the fungicide 

flutriafol in or on the following raw 

agricultural commodities: Apple at 0.2 

parts per million (ppm); apple, wet 

pomace at 0.3 ppm; soybean at 0.3 ppm; 

soybean, aspirated grain fractions at 0.5 

ppm; and liver (cattle, goat, hog, horse 

and sheep) at 0.01 ppm. That notice 

referenced a summary of the petition 

prepared by Cheminova A/S, c/o 

Cheminova Inc., the registrant, which is 

available to the public in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

determined that tolerances are not 

needed for apple, juice; wet apple 

pomace; soybean meal; soybean hull; 

and soybean oil. Additionally, 

tolerances were increased for soybean 

seed; aspirated grain fractions; and 

cattle, goat, hog, horse and sheep liver. 

The reason for these changes are 

explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

tolerances for residues of flutriafol 

including its metabolites and degradates 

in or on apple at 0.20 ppm; soybean, 

seed at 0.35 ppm; grain, aspirated 

fractions at 2.2 ppm; and cattle, goat, 

hog, horse and sheep liver at 0.02 ppm. 

EPA’s assessment of exposures and risks 

associated with establishing tolerances 

follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by flutriafol as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies can 

be found at http://www.regulations.gov 

in document Flutriafol. Human-Health 

Risk Assessment for Proposed Uses on 

Apple and Soybean at page 20 in docket 

ID number EPA–HQ–OPP–2009–0184. 

Flutriafol has low acute oral and 

inhalation toxicity. A 28–day dermal 

toxicity study did not reveal any signs 

of toxicity at the limit dose (1,000 mg/ 

kg/day). Thus, flutriafol is not 

considered to be acutely toxic via the 

dermal route. Flutriafol is minimally 

irritating to the eyes and is not a dermal 

irritant. Flutriafol was not shown to be 

a skin sensitizer when tested in guinea 

pigs. 

The pattern of toxicity attributed to 

flutriafol exposure via the oral route 

includes hepatotoxicity, developmental 

toxicity (manifested as increased 

intrauterine death) at the same dose as 

parental toxicity, and generalized 

toxicity (body weight/body weight gains 

and food consumption decrements as 

well as slight anemia). 

Short-term, subchronic, and chronic 

toxicity studies in rats, mice, and dogs 

identified the liver as the primary target 

organ of flutriafol. Hepatotoxicity was 

first evident in the subchronic studies 

(rats and dogs) in the form of increases 

in liver enzymes (alkaline phosphatase), 

liver weights, and histopathology 

findings ranging from hepatocyte 

vacuolation to centrilobular 

hypertrophy and slight increases in 

hemosiderin-laden Kupffer cells. With 

chronic exposures, there were no 

indications of progression of liver 

toxicity in either species. Neither the 

chronic/carcinogenicity study in rats 

nor the carcinogenicity study in mice 

revealed treatment-related increases in 

tumor incidences. 

Slight indications of effects on red 

blood cells were sporadically seen in 

the database. These effects were 

manifested in the form of slight anemia 

and increased hemosiderin in the liver 

or spleen of rats and dogs. Increased 

platelet, white blood cell, neutrophil, 

and lymphocyte counts were also 

observed in one study in mice. 

However, these effects were minimal in 

severity, were not considered adverse, 

and were not observed in any other 

study or species. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

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26670 Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. For more information on 

the general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for flutriafol used for human 

risk assessment can be found at http:// 

www.regulations.gov in document 

Flutriafol. Human-Health Risk 

Assessment for Proposed Uses on Apple 

and Soybean at page 20 in docket ID 

number EPA–HQ–OPP–2009–0184. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to flutriafol, EPA considered 

exposure under the petitioned-for 

tolerances for soybean and apples. 

Tolerances have been previously 

established in 40 CFR 180.629 in or on 

soybean treated under section 18 of 

FIFRA. EPA assessed dietary exposures 

from flutriafol in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

In conducting the acute dietary 

exposure assessment, EPA used the 

Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM-FCIDTM, version 

2.03) which incorporates food 

consumption data as reported by 

respondents in the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). The following 

assumptions were made for the acute 

exposure assessment: Tolerance-level 

residues, 100% crop treated (CT), and 

DEEMTM version 7.81 default 

processing factors were used. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the DEEMTM

software with DEEM-FCIDTM, version 

2.03 which incorporates food 

consumption data as reported by 

respondents in the USDA 1994–1996 

and 1998 Nationwide CSFII. The 

following assumptions were made for 

the chronic exposure assessment: 

Tolerance-level residues, 100% CT, and 

DEEMTM version 7.81 default 

processing factors were used. 

iii. Cancer. The Agency classified 

flutriafol as ‘‘Not Likely to be 

Carcinogenic to Humans’’ based on the 

results of the carcinogenicity studies in 

rats and mice. All genotoxicity studies 

on flutriafol showed no evidence of 

clastogenicity or mutagenicity. 

Flutriafol is a member of a class of 

pesticides known as triazoles. Although 

several triazoles are carcinogenic, many 

are not and flutriafol has been 

adequately tested and found not to be 

carcinogenic in long-term studies in rats 

and mice. Structure-activityrelationship analysis indicates that 

flutriafol may have the potential to 

produce thyroid and/or liver tumors in 

rodents. However, in the rat and mouse 

carcinogenicity studies, there were no 

treatment-related increases in tumor 

incidence when comparing treated 

animals to controls. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for flutriafol. Tolerance level residues 

and 100% CT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for flutriafol in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of flutriafol. 

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 

flutriafol for acute exposures are 

estimated to be 48.8 parts per billion 

(ppb) for surface water and 4.8 ppb for 

ground water. For chronic exposures for 

non-cancer assessments are estimated to 

be 5.7 ppb for surface water and 4.8 ppb 

for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 48.8 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 5.7 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). 

Flutriafol 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.’’ 

Flutriafol is a member of the triazolecontaining class of pesticides. Although 

conazoles act similarly in plants (fungi) 

by inhibiting ergosterol biosynthesis, 

there is not necessarily a relationship 

between their pesticidal activity and 

their mechanism toxicity in mammals. 

Structural similarities do not constitute 

a common mechanism of toxicity. 

Evidence is needed to establish that the 

chemicals operate by the same, or 

essentially the same, sequence of major 

biochemical events. In conazoles, 

however, a variable pattern of 

toxicological responses is found; some 

are hepatotoxic and hepatocarcinogenic 

in mice. Some induce thyroid tumors in 

rats. Some induce developmental, 

reproductive, and neurological effects in 

rodents. Furthermore, the conazoles 

produce a diverse range of biochemical 

events including altered cholesterol 

levels, stress responses, and altered 

DNA methylation. It is not clearly 

understood whether these biochemical 

events are directly connected to their 

toxicological outcomes. Thus, there is 

currently no evidence to indicate that 

conazoles share common mechanisms of 

toxicity and EPA is not following a 

cumulative risk approach based on a 

common mechanism of toxicity for the 

conazoles. For information regarding 

EPA’s procedures for cumulating effects 

from substances found to have a 

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Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 26671 

common mechanism of toxicity, see 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative. 

Triazole-derived pesticides can form 

the metabolite 1,2,4-triazole (T) and two 

triazole conjugates triazolylalanine (TA) 

and triazolylacetic acid (TAA). To 

support existing tolerances and to 

establish new tolerances for triazolederivative pesticides, EPA conducted an 

initial human-health risk assessment for 

exposure to T, TA, and TAA resulting 

from the use of all current and pending 

uses of any triazole-derived fungicide as 

of September 1, 2005. The risk 

assessment was a highly conservative, 

screening-level evaluation in terms of 

hazards associated with common 

metabolites (e.g., use of a maximum 

combination of uncertainty factors) and 

potential dietary and non-dietary 

exposures (i.e., high-end estimates of 

both dietary and non-dietary exposures). 

In addition, the Agency retained the 

additional 10X FQPA SF for the 

protection of infants and children. The 

assessment included evaluations of risks 

for various subgroups, including those 

comprised of infants and children. The 

Agency’s complete risk assessment can 

be found in the propiconazole 

reregistration docket at http:// 

www.regulations.gov, Docket 

Identification (ID) Number EPA–HQ– 

OPP–2005–0497. 

The Agency completed an updated 

dietary risk assessment considering 

exposure to T, TA, and TAA based on 

established and proposed uses of 

triazole fungicides; however, this risk 

assessment did not include flutriafol 

uses. The resulting acute and chronic 

exposure to T, TA, and TAA were less 

than the Agency’s level of concern (T: 

≤36% aPAD and ≤54% cPAD; TA/TAA: 

34% aPAD and ≤40% cPAD). The 

Agency concludes that revised T and 

TA/TAA dietary risk assessments are 

unnecessary for the following reasons: 

(1) Incorporation of the flutriafol uses 

resulted in negligible changes to the T 

and TA/TAA residue estimates 

incorporated into the previous dietary 

analyses and (2) the T and TA/TAA 

drinking water estimates incorporated 

into the previous dietary analyses 

assumed an annual fungicide 

application rate of 10.38 pound active 

ingredient/acre (lb ai/acre) for 

nonagricultural uses and 2.0 lb ai/acre 

for agricultural uses and the formation 

of T and/or TA/TAA at 30.7% of the 

applied rate. Since the annual 

application rate for flutriafol is ≤0.63 lb 

ai/acre and since all environmental 

degradates were identified at <10% total 

radioactive residue (TRR), a revised 

drinking water assessment was 

unnecessary. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

The potential impact of in utero and 

perinatal flutriafol exposure was 

investigated in three developmental 

toxicity studies (two in rats, one in 

rabbits) and a multigeneration 

reproduction toxicity study in rats. Only 

one of the rat developmental toxicity 

studies was acceptable. Qualitative 

susceptibility was noted in the 

acceptable rat developmental study and 

in the two-generation reproduction 

study. 

In the acceptable rat developmental 

study, developmental toxicity (late 

resorptions, skeletal malformations and 

variations, decrease in fetal weights) 

occurred at the same dose level that 

elicited maternal toxicity (late 

resorptions, decreased food 

consumption, body weight gains). In 

rabbits, a decreased number of live 

fetuses were observed at the same dose 

that also caused adverse effects in 

maternal animals (complete litter 

resorptions, increased post-implantation 

loss, decreased body weight gain and 

food consumption). 

In the two-generation reproduction 

study, effects in the offspring (decreased 

litter size and percentage of live births 

and liver toxicity) were observed at the 

same dose as parental toxicity 

(decreased body weight and food 

consumption and liver toxicity) and 

may be related to the systemic toxicity 

of the parents. There is no concern for 

the offspring toxicity observed in the 

developmental and reproductive 

toxicity studies for the following 

reasons: (1) the effects were seen in the 

presence of maternal/parental/systemic 

toxicity; (2) clear NOAELs and LOAELs 

were established in the fetuses/ 

offspring; (3) the dose-response for these 

effects are well defined and 

characterized; and (4) developmental 

endpoints are used for assessing acute 

dietary risks to the most sensitive 

population (females 13–49) as well as 

all other short- and intermediate-term 

exposure scenarios. 

3. Conclusion. EPA has determined 

that reliable data show that it would be 

safe for infants and children to reduce 

the FQPA safety factor to 1X. That 

decision is based on the following 

findings. 

• Except for an immunotoxicity 

study, the toxicological database is 

complete. In accordance with the 

revised part 158 an immunotoxicity 

study is required. In the case of 

flutriafol, there was no evidence of 

toxicity to the immune organs in any 

study in the database. Increased 

hemosiderin in the spleen was observed 

in rats or dogs. However, this was 

considered due to the storage of iron 

following the clearance of damaged 

erythrocytes from the blood and not to 

an immunotoxic effect. Increased 

platelet, white blood cell, neutrophil, 

and lymphocyte counts were also 

observed in one study in mice. 

However, these effects were minimal in 

severity, were not considered adverse, 

and were not observed in any other 

study or species. Therefore, they are not 

considered immunotoxic effects. 

In addition, flutriafol does not belong 

to a class of chemicals (e.g., the 

organotins, heavy metals, or 

halogenated aromatic hydrocarbons) 

that would be expected to be 

immunotoxic. Based on the above 

considerations, the Agency does not 

believe that conducting a special series 

OPPTS Harmonized Guideline 870.7800 

immunotoxicity study will result in a 

point of departure lower than that used 

for overall risk assessment. Therefore an 

additional UFDB does not need to be 

applied. 

• There are no concerns or residual 

uncertainties for pre- and/or post-natal 

toxicity. There is no evidence of 

quantitative susceptibility following in 

utero exposures to rats or rabbits and 

following pre- and post-natal exposures 

to rats for two generations. There is no 

concern for the offspring toxicity 

observed in the developmental and 

reproductive toxicity studies for the 

following reasons: (1) The effects were 

seen in the presence of maternal/ 

parental systemic toxicity; (2) clear 

NOAELs and LOAELs were established 

in the fetuses/offspring; (3) the doseresponse for these effects are well 

defined and characterized; and (4) 

developmental endpoints are used for 

assessing acute dietary risks to the most 

sensitive population (females 13–49) as 

well as all other short- and 

intermediate-term exposure scenarios. 

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26672 Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 

• There is no concern for 

neurotoxicity with flutriafol. Signs of 

neurotoxicity were reported in the acute 

and subchronic neurotoxicity studies at 

the highest dose only; however, these 

effects were primarily seen in animals 

that were agonal (at the point of death) 

and, thus are not indicative of 

neurotoxicity. In addition, there was no 

evidence of neurotoxicity in any 

additional short-term studies in rats, 

mice, and dogs, or in the long-term 

toxicity studies in rats, mice, and dogs. 

• A developmental neurotoxicity 

study is not required. 

• The dietary exposure assessment is 

conservative in nature (utilized 

tolerance level residues and 100% CT 

were utilized). 

• Conservative (protective) 

assumptions were used in the ground 

water and surface water modeling to 

assess exposure to flutriafol in drinking 

water. 

• There are no proposed residential 

uses. 

• Based on summaries of confined/ 

field rotational crop studies submitted 

by the petitioner, the Agency 

determined that rotation of only 

soybean to a treated field was 

acceptable. The Agency is requesting 

that the petitioner submit a detailed 

version of these studies and views this 

requirement as confirmatory and, 

therefore, not requiring the application 

of additional uncertainty factors. 

• Storage stability data for flutriafol 

and/or its metabolites in/on livestock 

and soybean commodities have been 

requested. Based on the available 

storage stability data, which did not 

result in the degradation of flutriafol or 

its metabolites in a variety of matrices, 

the Agency views these data as 

confirmatory and, therefore, not 

requiring the application of additional 

uncertainty factors. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

flutriafol will occupy 3.7% of the aPAD 

for (females 13–49 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 flutriafol from 

food will utilize 4.6% of the cPAD for 

(children 1 to 2 years old) the 

population group receiving the greatest 

exposure. There are no proposed or 

existing residential uses of flutriafol. 

Therefore, chronic dietary exposure to 

flutriafol is not a concern to the Agency. 

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). 

Flutriafol is not registered for any use 

patterns that would result in residential 

exposure. Therefore, the short-term 

aggregate risk is the sum of the risk from 

exposure to flutriafol through food and 

water and will not be greater than the 

chronic aggregate risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Flutriafol is not registered for any use 

patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to flutriafol through food and 

water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. For flutriafol there were no 

treatment-related increases in tumor 

incidence when comparing treated 

animals to controls in the rat and mouse 

carcinogenicity studies. Therefore, the 

human cancer risk from flutriafol is 

negligible. 

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 flutriafol 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies 

(multiresidue method (MRM) Protocol D 

for apples; GC/Nitrogen/Phosphorus 

detector (NPD) method for soybean seed 

and method ICIA AM00306 for 

ruminant liver) are available to enforce 

the tolerance expression. The 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 

There are no currently established 

Codex, Canadian, or Mexican maximum 

residue limits for flutriafol on apples 

and soybeans. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the processing data, the 

Agency determined that apple juice, wet 

apple pomace, soybean meal, soybean 

hull, and soybean oil tolerances are 

unnecessary. However, a tolerance for 

grain, aspirated fractions at 2.2 is 

required. Based on the crop field trial 

data, livestock feeding study, and/or the 

tolerance calculator, EPA is 

recommending for higher tolerances 

than that proposed by the petitioner for 

soybean, seed; aspirated grain fractions, 

and liver (cattle, goat, hog, horse, and 

sheep). 

V. Conclusion 

Therefore, tolerances are established 

for residues of flutriafol including its 

metabolites and degradates in or on 

apple at 0.20 ppm; soybean, seed at 0.35 

ppm; grain, aspirated fractions at 2.2 

ppm; cattle, goat, hog, horse and sheep 

liver at 0.02 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 

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Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 26673 

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: April 28, 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. Revise § 180.629 to read as follows: 

180.629 Flutriafol; tolerances for residues. 

(a) General. Tolerances are 

established for the residues of flutriafol, 

[(±)-a-(2-fluorophenyl)-a-(4- 

fluorophenyl)-1H-1,2,4-triazole-1- 

ethanol], including its metabolites and 

degradates in or on the following 

commodities. Compliance with the 

following tolerances is to be determined 

by measuring flutriafol only. 

Commodity Parts per million 

Apple ............................... 0.20 

Cattle, liver ...................... 0.02 

Goat, liver ....................... 0.02 

Grain, aspirated fractions 2.2 

Hog, liver ........................ 0.02 

Horse, liver ..................... 0.02 

Sheep, liver ..................... 0.02 

Soybean, seed ................ 0.35 

(b) Section 18 tolerance [Reserved]. 

(c) Tolerances with regional 

registrations [Reserved]. 

(d) Indirect or inadvertent residues 

[Reserved]. 

[FR Doc. 2010–11296 Filed 5–11–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0307; FRL–8822–7] 

Clethodim; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of clethodim in 

or on the raw agricultural commodity 

artichoke, globe; bushberry subgroup 

13-07B; caneberry subgroup 13-07A; 

and peach. This regulation additionally 

removes the existing tolerances on 

lettuce leaf and spinach, as they are 

covered by the leafy greens subgroup 4A 

and removes the tolerance for flax seed 

at 0.50 ppm because there is one for flax 

seed at 0.6 ppm. The 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–2009–0307. 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: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@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: 

WReier-Aviles on DSKGBLS3C1PROD with RULES