80346 Federal Register / Vol. 75, No. 245 / Wednesday, December 22, 2010 / Rules and Regulations 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). Since tolerances and exemptions 

that are established on the basis of a 

petition under section 408(d) of FFDCA, 

such as the tolerance in this final rule, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

V. 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: December 10, 2010. 

Daniel J. Rosenblatt, 

Acting 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. 

§ 180.430 [Amended] 

■ 2. In § 180.430, in the table to 

paragraph (b), amend the entries for 

‘‘Grass, forage’’ and ‘‘Grass, hay’’ by 

revising the expiration dates ‘‘12/31/10’’ 

to read ‘‘12/31/13.’’ 

§ 180.434 [Amended] 

■ 3. In § 180.434, in the table to 

paragraph (b), amend the entries for 

‘‘Nectarine’’ and ‘‘Peach’’ by revising the 

expiration dates ‘‘12/31/10’’ to read 

‘‘12/31/13.’’ 

§ 180.449 [Amended] 

■ 4. In § 180.449, in the table to 

paragraph (b), amend the entry for 

‘‘Bean, lima, seed’’ by revising the 

expiration date ‘‘12/31/10’’ to read 

‘‘12/31/13.’’ 

§ 180.498 [Amended] 

■ 5. In § 180.498, in the table to 

paragraph (b), amend the entries for 

‘‘Flax, seed’’ and ‘‘Strawberry’’ by 

revising the expiration dates ‘‘12/31/10’’ 

to read ‘‘12/31/13.’’ 

§ 180.517 [Amended] 

■ 6. In § 180.517, in the table to 

paragraph (b), amend the entries for 

‘‘Rutabaga’’ and ‘‘Turnip’’ by revising the 

expiration dates ‘‘12/31/10’’ to read 

‘‘12/31/13.’’ 

§ 180.566 [Amended] 

■ 7. In § 180.566, in the table to 

paragraph (b), amend the entry for 

‘‘Honey’’ by revising the expiration date 

‘‘12/31/10’’ to read ‘‘12/31/13.’’ 

§ 180.572 [Amended] 

■ 8. In § 180.572, in the table to 

paragraph (b), amend the entries for 

‘‘Timothy, forage,’’ and ‘‘Timothy, hay’’ 

by revising the expiration dates ‘‘12/31/ 

10’’ to read ‘‘12/31/13.’’ 

§ 180.582 [Amended] 

■ 9. In § 180.582, in the table to 

paragraph (b), amend the entry for 

‘‘Endive, Belgian’’ by revising the 

expiration date ‘‘12/31/10’’ to read 

‘‘12/31/13.’’ 

§ 180.589 [Amended] 

■ 10. In § 180.589, in the table to 

paragraph (b), amend the entry for 

‘‘Endive, Belgian’’ by revising the 

expiration date ‘‘12/31/10’’ to read 

‘‘12/31/13.’’ 

[FR Doc. 2010–32148 Filed 12–21–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0775; FRL–8855–7] 

Flutolanil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of flutolanil in or 

on Brassica leafy vegetable group 5 and 

turnip greens. The Interregional 

Research Project Number 4 requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 22, 2010. Objections and 

requests for hearings must be received 

on or before February 22, 2011, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0775. 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– 


emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 75, No. 245 / Wednesday, December 22, 2010 / Rules and Regulations 80347 

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: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

You may access Harmonized Guidelines 

referenced in this document at http:// 

www.epa.gov/ocspp/pubs/frs/home/ 

guideline.htm. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0775 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 February 22, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0775, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of January 6, 

2010 (75 FR 864) (FRL–8801–5), 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 9E7612) by the 

Interregional Research Project No. 4 (IR– 

4), 500 College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.484 be 

amended by establishing tolerances for 

residues of the fungicide flutolanil, 

N-(3-(1-methylethoxy)phenyl)-2- 

(trifluoromethyl)benzamide and its 

metabolites converted to 

2-(trifluoromethyl) benzoic acid and 

calculated as flutolanil, in or on ginseng 

at 3.5 parts per million (ppm); vegetable, 

Brassica, leafy, group 5 at 0.11 ppm; and 

turnip, greens at 0.11 ppm. That notice 

referenced a summary of the petition 

prepared by Gowan Company, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

IR–4 later withdrew their request to 

establish a tolerance on ginseng. Also, 

EPA has revised the tolerance levels 

proposed by IR–4. 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 flutolanil 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with flutolanil 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. The toxicology 

studies conducted on flutolanil 

demonstrate few or no biologically 

significant toxic effects. Liver effects in 


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rats included increases in absolute and 

relative liver weight in the absence of 

clinical chemistry and/or 

histopathology findings. In dogs, there 

was an elevation in alkaline 

phosphatase and cholesterol levels 

together with dose-related increases in 

absolute and relative liver weights, 

slightly enlarged livers, and an increase 

in severity of glycogen deposition. The 

increased liver weights are considered 

to be an adaptive response to flutolanil 

treatment and not an adverse effect. 

Based on the lack of evidence of 

carcinogenicity and the lack of evidence 

of mutagenicity, flutolanil is classified 

as ‘‘not likely to be carcinogenic to 

humans.’’ 

Flutolanil is not neurotoxic, and it is 

not a developmental or reproductive 

toxicant. No maternal, reproductive, or 

developmental toxicity was observed at 

the limit dose. There was no evidence 

for increased susceptibility of rat or 

rabbit fetuses to in utero exposure or rat 

pups to pre- and post-natal exposure to 

flutolanil. No toxic effects were 

observed in studies in which flutolanil 

was administered by the dermal route of 

exposure at the limit dose. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by flutolanil 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 docket ID 

number EPA–HQ–OPP–2009–0775 in 

the document titled ‘‘Flutolanil: Human 

Health Risk Assessment for Flutolanil 

on Brassica Leafy Vegetables (Crop 

Group 5) and Turnip Greens’’ on pages 

27–30. 

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 flutolanil used for human 

risk assessment is discussed in Unit 

III.B., of the final rule published in the 

Federal Register of June 11, 2008 (73 FR 

33013) (FRL–8365–6). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to flutolanil, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

flutolanil tolerances in 40 CFR 180.484. 

EPA assessed dietary exposures from 

flutolanil in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

No such effects were identified in the 

toxicological studies for flutolanil; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the U.S. Department of Agriculture 

(USDA) 1994–1996 and 1998 

Continuing Survey of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, the chronic dietary analysis 

included tolerance level residues, 100% 

crop treated estimates and default 

processing factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that flutolanil does not pose 

a cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for flutolanil. Tolerance level residues 

and/or 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 flutolanil in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of flutolanil. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the Pesticide Root Zone 

Model and Exposure Analysis Modeling 

System (PRZM–EXAMs) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

flutolanil for chronic exposures are 

estimated to be 8.5 parts per billion 

(ppb) for surface water and 0.7 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 8.5 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). Flutolanil 

is currently registered for the following 

uses that could result in residential 

exposures: Turf grass and ornamental 

plants. Although there is a potential for 

residential (non-occupational) exposure, 

a quantitative exposure assessment was 

not conducted since no toxicological 

endpoint attributable to acute, shortterm or intermediate-term exposure 

have been identified and the current use 

pattern does not indicate chronic or 

long-term exposure (6 or more months 

of continuous exposure) potential. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

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

trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found flutolanil to share 

a common mechanism of toxicity with 

any other substances, and flutolanil 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 


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assumed that flutolanil 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 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There was no evidence of increased 

susceptibility of rat or rabbit fetuses to 

in utero exposure or rat pups to prenatal 

and postnatal exposure to flutolanil. 

Flutolanil is not a developmental or 

reproductive toxicant. No maternal, 

reproductive, or developmental toxicity 

was observed at the limit dose. 

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 flutolanil 

is complete except for acute and 

subchronic neurotoxicity and 

immunotoxicity studies. Recent changes 

to 40 CFR part 158 make acute and 

subchronic neurotoxicity testing 

(OPPTS Test Guideline 870.6200), and 

immunotoxicity testing (OPPTS Test 

Guideline 870.7800) required for 

pesticide registration. However, the 

available data for flutolanil do not 

suggest that the compound produces 

hematological or thymus/spleen organ 

effects indicative of immunotoxicity. 

Further, there is no evidence of 

neurotoxicity in any study in the 

toxicity database for flutolanil. 

Therefore, EPA does not believe that 

conducting neurotoxicity and 

immunotoxicity studies will result in a 

lower POD than currently used for 

overall risk assessment. Consequently, 

an additional database uncertainty 

factor (UF) does not need to be applied. 

ii. There is no indication that 

flutolanil is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

flutolanil exposure results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100% CT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to flutolanil in 

drinking water. Residential exposure 

does not pose a concern for flutolanil 

because (1) chronic residential exposure 

is not expected; and (2) although shortterm or intermediate-term residential 

exposure may occur, no relevant 

adverse effects were identified for 

dermal or incidental oral or inhalation 

exposure related to residential use. 

These assessments will not 

underestimate the exposure and risks 

posed by flutolanil. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, flutolanil is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to flutolanil from 

food and water will utilize 1.5% of the 

cPAD for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of flutolanil is not expected. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Because no short- and/ 

or intermediate-term adverse effects 

were identified, flutolanil is not 

expected to pose a short- or 

intermediate-term risk. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

flutolanil is not expected to pose a 

cancer risk to humans. 

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 flutolanil 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement 

methodology, (Method AU/95R/04), a 

common moiety Gas Chromatography/ 

Mass Spectrometry (GC/MS) method 

which determines residues of flutolanil 

and metabolites as 2-trifluoromethyl 

benzoic acid (2–TFBA) is available for 

enforcement. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

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

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. No 

Canadian, Mexican or Codex MRLs have 

been established for Brassica leafy 

vegetables and/or turnip greens. 


emcdonald on DSK2BSOYB1PROD with RULES
80350 Federal Register / Vol. 75, No. 245 / Wednesday, December 22, 2010 / Rules and Regulations 

C. Revisions to Petitioned-For 

Tolerances 

The proposed tolerance level of 0.11 

ppm for both Brassica leafy vegetable 

group 5 and turnip greens has been 

revised to 0.1 ppm. The level of 0.1 ppm 

is based on the sum of the demonstrated 

levels of quantitation of flutolanil and 

metabolite M4, each 0.05 ppm. The 

proposed tolerance of 0.11 ppm is based 

on one mustard green trial (of 10 trials) 

where flutolanil was quantitated at 0.05 

to 0.06 ppm, and M4 was approximately 

0.03 ppm. Because total residues were 

< 0.1 ppm, EPA is setting the tolerance 

level at 0.1 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of flutolanil, N-(3-(1- 

methylethoxy)phenyl)-2- 

(trifluoromethyl)benzamide, including 

its metabolites and degradates, in or on 

vegetable, brassica, leafy group 5 at 0.1 

ppm, and turnip greens at 0.1 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) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

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: December 10, 2010. 

Daniel J. Rosenblatt, 

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 180.484 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.484 Flutolanil; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

* * * * * 

Turnip, greens ...................... 0.1 

Vegetable, brassica, leafy, 

group 5 .............................. 0.1 

[FR Doc. 2010–32147 Filed 12–21–10; 8:45 am] 

BILLING CODE 6560–50–P 

GENERAL SERVICES 

ADMINISTRATION 

41 CFR Parts 300–3, 301–10, 301–12, 

301–30, 301–70, Chapter 301, Parts 

302–1, 302–2, 302–3, 302–7, 302–11, 

and 303–70 

[FTR Amendment 2010–07; FTR Case 2010– 

307; Docket 2010–0020, Sequence 1] 

RIN 3090–AJ09 

Federal Travel Regulation; Removal of 

Privately Owned Vehicle Rates; 

Privately Owned Automobile Mileage 

Reimbursement When Government 

Owned Automobiles Are Authorized; 

Miscellaneous Amendments; 

Correction 

AGENCY: Office of Governmentwide 

Policy, General Services Administration 

(GSA). 

ACTION: Final rule; correction. 

SUMMARY: GSA is correcting a final rule 

that appeared in the Federal Register on 

November 29, 2010. The applicability 

date for the final rule was incorrectly 

designated December 29, 2010. This 

final rule correction document corrects 

the applicability date to January 1, 2011. 

DATES: The effective date for the final 

rule published on November 29, 2010 at 

75 FR 72965 remains November 29, 

2010. The applicability date is corrected 

to January 1, 2011. 

FOR FURTHER INFORMATION CONTACT: The 

Regulatory Secretariat (MVCB), 1275 

First Street, NE., Washington, DC, 

20417, (202) 501–4755, for information 

pertaining to status or publication 

schedules. For clarification of content, 


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