17566 Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 

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). 

IV. 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: March 26, 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. 

§ 180.628 [Amended] 

■ 2. In § 180.628, amend the table in 

paragraph (d) by revising the expiration/ 

revocation dates ‘‘4/10/10’’ to read ‘‘4/ 

10/14,’’ each time it appears. 

[FR Doc. 2010–7744 Filed 4–6–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0553; FRL–8817–9] 

Flutolanil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of flutolanil in or 

on cotton and soybean. Nichino 

America, Inc. requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

7, 2010. Objections and requests for 

hearings must be received on or before 

June 7, 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–2009–0553. 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: Lisa 

Jones, Registration Division, Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (703) 308– 

9424; e-mail address: 

jones.lisa@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 OPPTS harmonized test 

guidelines referenced in this document 

electronically, please go http:// 

www.epa.gov/oppts 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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Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 17567 

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–2009–0553 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 June 7, 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–2009–0553, 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 September 

4, 2009 (74 FR 45848) (FRL–8434–4), 

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 9F7542) by 

Nichino America, Inc., 4550 New 

Linden Hill Rd., Suite 501, Wilmington, 

DE 19808. 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 

metabolite, M-4, desisopropylflutolanil 

(N-(3-hydroxyphenyl)-2-(trifluromethyl) 

benzamide), expressed as 2- 

trifluoromethyl benzoic acid and 

calculated as flutolanil, in or on cotton 

at 0.05 parts per million (ppm) and in 

or on soybean at 0.05 ppm. That notice 

referenced a summary of the petition 

prepared by Nichino America, Inc., the 

registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

EPA has modified the proposed 

tolerance expression to: ‘‘residues of 

flutolanil, (N-(3-(1-methylethoxy) 

phenyl)-2-(trifluoromethyl) benzamide), 

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 flutolanil 

and its metabolites converted to 2- 

(trifluoromethyl) benzamide and 

calculated as flutolanil.’’ Based on 

review of the data supporting the 

petition, EPA has also modified the 

proposed tolerances to be established 

under paragraph (a), General, for 

flutolanil at 40 CFR 180.484 as follows: 

Soybean, seed, 0.20 ppm; soybean, 

forage, 8.0 ppm; soybean, hay, 2.5 ppm; 

cotton, undelinted seed, 0.20 ppm and 

cotton, gin byproducts, 0.20 ppm. 

Additionally, the following tolerances 

will be removed from paragraph (d), 

Indirect or inadvertent residues, for 

flutolanil as redundant: Soybean, seed 

0.20 ppm; soybean, forage, 8.0 ppm and 

soybean hay, 2.5 ppm. The reasons 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 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. 

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 are discussed in the 

final rule published in the Federal 

Register of June 11, 2008, (73 FR 33013) 

(FRL–8365–6). The complete 

toxicological profile for flutolanil can be 

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

pages 7 through 12 in the document 

‘‘Flutolanil, Human Health Risk 

Assessment: Requests for Inadvertent or 

Indirect Tolerances for Use on Soybean, 

Wheat, Corn and Cotton’’ in docket ID 

number EPA–HQ–OPP–2007–1021. 

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 

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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, 

Aggregate Risk Assessment and 

Determination of Safety, 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 

percent crop treated estimates and 

processing factors (default). 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight-ofthe-evidence from cancer studies and 

other relevant data. Cancer risk is 

quantified using a linear or nonlinear 

approach. If sufficient information on 

the carcinogenic mode of action is 

available, a threshold or non-linear 

approach is used and a cancer RfD is 

calculated based on an earlier 

noncancer key event. If carcinogenic 

mode of action data are not available, or 

if the mode of action data determines a 

mutagenic mode of action, a default 

linear cancer slope factor approach is 

utilized. Based on the lack of evidence 

of carcinogenicity in two rodent studies 

and the lack of evidence of 

mutagenicity, flutolanil is not expected 

to 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 treaded (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. 

The Agency used the First 

Approximation Rice Model (FARM) to 

estimate pesticide concentrations in 

surface water after applying flutolanil 

on rice and Screening Concentrations in 

Ground Water (SCI-GROW), which 

predicts pesticide concentrations in 

ground water. In general, EPA will use 

Generic Expected Environmental 

Concentrations (GENEEC) (a Tier 1 

model) before using Pesticide Root 

Zone/Exposure Analysis Modeling 

System (PRZM/EXAMS) (a Tier 2 

model) for a screening-level assessment 

for surface water, but given the unique 

hydrological issues arising from 

pesticide application to rice paddies, 

EPA used the FARM rather than 

GENEEC or PRZM/EXAMS for surface 

water estimates. 

Based on the SCI-GROW model, and 

the FARM (to estimate pesticide 

concentrations in surface water after 

applying flutolanil on rice) the 

estimated environmental concentrations 

(EECs) of flutolanil for acute exposures 

are estimated to be 3.8 parts per billion 

(ppb) for surface water and 0.34 ppb for 

ground water. The EEC for peak acute 

exposure is estimated to be 11.6 ppb for 

surface water. The EECs for chronic 

exposures are estimated to be 3.8 ppb 

for surface water and 0.34 ppb for 

ground water. 

For chronic dietary risk assessment, 

the water concentration of value 3.8 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. EPA assessed 

residential exposure using the following 

assumptions: Although residential (nonoccupational) exposure exists, 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 

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 

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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 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 

NOAEL lower than the NOAEL of 50 

milligrams/kilogram/day (mg/kg/day) 

already established for flutolanil. 

Consequently, an additional database 

uncertainty factor 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 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 water 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 short-term or intermediateterm 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 population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-term, intermediate-term, 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 2% of the 

cPAD for children between 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-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure take into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because no short- or intermediateterm adverse effect was identified, 

flutolanil is not expected to pose a 

short-term or intermediate-term risk. 

4. Aggregate cancer risk for U.S. 

population. EPA has classified flutolanil 

as ‘‘not likely’’ to be a human 

carcinogen. 

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 to 

enforce the tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

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

B. International Residue Limits 

Codex maximum residue limits 

(MRLs) are established for residues of 

flutolanil in rice commodities at 1–10 

ppm, and in livestock commodities at 

0.05–0.2 ppm. No Canadian or Mexican 

MRLs have been established. No Codex 

MRLs are established for soybean, 

cotton seed, or sugar beet commodities. 

C. Response to Comments 

One comment was received from a 

private citizen objecting to the 

establishment of tolerances for 

flutolanil. The commenter criticized 

EPA’s reliance on toxicology testing on 

animals. The Agency has received, and 

responded to, similar comments from 

this commenter on numerous previous 

occasions. Refer to the Federal Register 

issues of June 30, 2005 (70 FR 37686), 

January 7, 2005 (70 FR 1354), October 

28, 2004 (FR 69 63096) for the Agency’s 

response to these objections. 

D. Revisions to Petitioned-For 

Tolerances 

The Agency is establishing tolerances 

that are greater than the proposed 

tolerance for soybean seed and cotton 

seed because the enforcement analytical 

method has not been validated at a level 

below 0.20 ppm, and the greater 

tolerance value is needed to 

accommodate indirect residues from 

soybean rotational crops. Additional 

tolerances are established for cotton gin 

byproducts, as the radiolabeled seed 

treatment study revealed residues on 

cotton gin trash, and soybean hay to 

accommodate the seed treatment use 

and the inadvertent residue from 

soybean as a rotational crop. 

EPA is revising the tolerance 

expression in §180.484 to clarify that, as 

provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of flutolanil not specifically 

mentioned; and that compliance with 

the specified tolerance levels is to be 

determined by measuring only the 

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17570 Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 

specific compounds mentioned in the 

tolerance expression. The tolerance 

definition previously read ‘‘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.’’ It is being 

changed to ‘‘residues of flutolanil, N-(3- 

(1-methylethoxy)phenyl)-2- 

(trifluoromethyl)benzamide, including 

its metabolites and degradates, in or on 

the commodities. Compliance with the 

tolerance levels is to be determined by 

measuring only flutolanil and its 

metabolites converted to 2- 

(trifluoromethyl) benzoic acid and 

calculated as flutolanil.’’ 

Finally, the inadvertent residue, 

rotational crop tolerances previously 

established for soybean forage and 

soybean hay encompass the use on 

soybean as a seed treatment. Therefore 

the tolerances established under 

paragraph (d), Indirect or inadvertent 

residues, for soybean, seed at 0.20 ppm; 

soybean, forage at 8.0 ppm, and soybean 

hay at 2.5 ppm are being revoked since 

the same tolerance values are being 

established under paragraph (a), 

General. 

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 

cotton, undelinted seed at 0.20 ppm; 

soybean, seed at 0.20 ppm; soybean, 

forage at 8.0 ppm; soybean, hay at 2.5 

ppm; cotton, gin byproducts at 0.20 

ppm. Compliance with the tolerance 

levels is to be determined by measuring 

only flutolanil and its metabolites 

converted to 2-(trifluoromethyl) benzoic 

acid and calculated as flutolanil. 

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: March 26, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Prorgams. 

■ 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 as 

follows: 

a. Revise the section heading. 

b. Revise the introductory text of 

paragraph (a). 

c. Add alphabetically entries to the 

table in paragraph (a) for cotton, gin 

byproducts; cotton, undelinted seed; 

soybean forage; soybean, hay; and 

soybean, seed. 

d. Revise paragraph (d). 

§ 180.484 Flutolanil; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of flutolanil, N- 

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

(trifluoromethyl)benzamide, 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 flutolanil and its 

metabolites converted to 2- 

(trifluoromethyl) benzoic acid and 

calculated as flutolanil, in or on the 

following commodities: 

Commodity Parts per million 

*****

Cotton, gin byproducts ... 0.20 

Cotton, undelinted seed 0.20 

*****

Soybean, forage ............. 8.0 

Soybean, hay .................. 2.5 

Soybean, seed ................ 0.20 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

indirect or inadvertent residues of 

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Federal Register / Vol. 75, No. 66 / Wednesday, April 7, 2010 / Rules and Regulations 17571 

flutolanil, N-(3-(1- 

methylethoxy)phenyl)-2- 

(trifluoromethyl)benzamide, 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 flutolanil and its 

metabolites converted to 2- 

(trifluoromethyl) benzoic acid and 

calculated as flutolanil, in or on the 

following commodities. 

Commodity Parts per million 

Wheat, bran .................... 0.20 

Wheat, forage ................. 2.5 

Wheat, grain ................... 0.05 

Wheat, hay ..................... 1.2 

Wheat, straw ................... 0.20 

* * * * * 

[FR Doc. 2010–7624 Filed 4–6–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0673; FRL–8817–4] 

Pendimethalin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

current tolerance for combined residues 

of pendimethalin and its metabolite, 

expressed as pendimethalin equivalents, 

in or on alfalfa forage. BASF 

Corporation requested this tolerance 

amendment under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

7, 2010. Objections and requests for 

hearings must be received on or before 

June 7, 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– 0673. 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: Jim 

Tompkins, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5697; e-mail address: 

tompkins.jim@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. 

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–2009–0673 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 June 7, 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–2009–0673, 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 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 9F7576) by BASF 

Corporation, 26 Davis Drive, Research 

Triangle Park, NC 27709. The petition 

requested that 40 CFR 180.361 be 

amended by increasing the tolerance for 

the combined residues of the herbicide 

pendimethalin, [N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine], and 

its metabolite 4-[(1-ethylpropyl)amino]- 

2-methyl-3,5-dinitrobenzyl alcohol, in 

or on alfalfa, forage from 3.0 parts per 

million (ppm) to 3.5 (ppm). That notice 

referenced a summary of the petition 

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