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: 

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• 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–2009–0307 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before July 12, 2010. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0307, 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 June 10, 

2009 (74 FR 27538) (FRL–8417–7), 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 8E7505) by IR-4 

Project Headquarters, Rutgers, The State 

University of New Jersey, 500 College 

Road East, Suite 201 W, Princeton, NJ 

08540. The petition requested that 40 

CFR 180.458 be amended by 

establishing tolerances for combined 

residues of the herbicide clethodim, 

((E)-()-2-[1-[[(3-chloro-2- 

propenyl)oxy]imino]propyl]-5-[2- 

(ethylthio)propyl]-3-hydroxy-2- 

cyclohexen-1-one) and its metabolites 

containing the 5-(2- 

(ethylthio)propyl]cyclohexen-3-one and 

the 5-[2-(ethylthio)propyl]-5- 

hydroxycyclohexen-3-one moieties and 

their sulfoxides and sulfones, expressed 

as clethodim, in or on the raw 

agricultural commodity artichoke, globe 

at 1.3 parts per million (ppm), 

bushberry subgroup 13-07B at 3.0 ppm, 

caneberry subgroup 13-07A at 0.30 ppm 

and peach at 0.20 ppm. That notice 

referenced a summary of the petition 

prepared by Valent U.S.A. Corporation, 

the registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the bushberry subgroup 13- 

07B tolerance from 3.0 ppm to 0.20 ppm 

and the globe artichoke tolerance from 

1.3 ppm to 1.2 ppm. The reason for 

these changes is 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 clethodim 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with clethodim 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. Clethodim has a 

low order of acute toxicity via oral, 

dermal and inhalation routes of 

exposure. Clethodim produces mild 

ocular irritation and moderate skin 

irritation. It is not a dermal sensitizer. 

The subchronic and chronic toxicity 

data show that clethodim produces 

consistent effects in the liver 

characterized by increased liver weights 

and centrilobular hepatic hypertrophy 

in rats, mice, and dogs. Decreased body 

weight is also a consistent finding. 

Treatment related increase in tumor 

incidence is not observed in rat and 

mouse carcinogenicity studies. 

Clethodim is not genotoxic. The data 

demonstrate no reproductive effect in 

rats and no developmental effects in 

rabbits. No effects were seen in offspring 

of the 2-generation study. In the rat 

developmental toxicity study, reduced 

fetal weights and increased incidence of 

reduced ossification were seen in the 

fetuses at the maternal toxic dose level. 

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The data show no increase in 

susceptibility in the young. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by clethodim 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 on pages 45-50 of 

the document titled ‘‘Clethodim Human 

Health Risk Assessment for Proposed 

Uses on Caneberry Subgroup 13-07A, 

Bushberry Subgroup 13-07B, Peach, and 

Globe Artichoke’’ in docket ID number 

EPA–HQ–OPP–2009–0307. 

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 clethodim used for human 

risk assessment is shown in the Table of 

this unit. 

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

ASSESSMENT

Exposure/Scenario 

Point of Departure and 

Uncertainty/Safety Factors 

RfD, PAD, LOC for 

Risk Assessment Study and Toxicological Effects 

Acute dietary 

(All Populations) 

N/A N/A None Selected. 

There were no effects observed in oral toxicity studies including developmental toxicity studies in rats and rabbits that 

could be attributable to a single dose (exposure). Therefore, 

a dose and endpoint were not selected for this exposure 

scenario. 

Chronic dietary 

(All populations) 

NOAEL= 1.0 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.01 mg/ 

kg/day 

cPAD = 0.01 mg/kg/day 

Chronic Toxicity-Dog (1–year). 

Alterations in hematology and clinical chemistry parameters 

and increased absolute and relative liver weights observed 

at the LOAEL of 75 mg/kg/day. 

Cancer 

(Oral, dermal, inhalation) 

Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on feeding studies in rats and mice. 

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

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

dose. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to clethodim, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

clethodim tolerances in 40 CFR 180.458. 

EPA assessed dietary exposures from 

clethodim 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 clethodim; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. The chronic dietary (food and 

drinking water) exposure assessment is 

partially refined, i.e., based on the 

assumption of tolerance-level residues 

for most commodities and average 

percent crop treated information for 

some crops. An anticipated residue (AR) 

value was used for succulent snap bean. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that clethodim is classified 

as ‘‘Not Likely to be Carcinogenic 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. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to section 408(f)(1) of FFDCA 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by section 408(b)(2)(E) of 

FFDCA and authorized under section 

408(f)(1) of FFDCA. Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

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derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by section 408(b)(2)(F) of 

FFDCA, EPA may require registrants to 

submit data on PCT. 

The Agency estimated the percent 

crop treated for existing uses as follows: 

Beets 1%, Broccoli 10%, Cabbage 1%, 

Cantaloupes 1%, Carrots 10%, Celery 

5%, Cotton 1%, Cucumbers 1%, Dry 

beans 5%, Lettuce 1%, Onions 10%, 

Peanuts 5%, Potatoes 5%, Pumpkins 

5%, Soybeans 5%, Squash 5%, 

Strawberries 1%, Sugar beets 45%, 

Sunflowers 20%, Sweet potatoes 1%, 

Tomatoes 1%, Watermelons 5%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which clethodim may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for clethodim in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of clethodim. 

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 

clethodim for chronic exposures for 

non-cancer assessments are 13.0 ppb for 

surface water and 9.8 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 value of 13.0 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). 

Clethodim is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found clethodim to share 

a common mechanism of toxicity with 

any other substances, and clethodim 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that clethodim does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

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

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (FQPA) 

Safety Factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence of increased 

susceptibility of fetuses as compared to 

maternal animals following in utero 

and/or postnatal exposure to clethodim 

in the developmental toxicity studies in 

rats or rabbits, and no increased 

sensitivity in pups as compared to 

adults in the 2–generation rat 

reproduction toxicity study. There are 

no residual uncertainties concerning 

prenatal and postnatal toxicity and no 

neurotoxicity concerns. 

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. Except for the new requirements of 

an immunotoxicity study and an acute 

and subchronic neurotoxicity battery, 

the available toxicity database for 

clethodim is sufficient and the exposure 

data are complete or are estimated based 

on data that reasonably account for 

potential exposures. In the absence of 

the immunotoxicity and acute and 

subchronic neurotoxicity studies, the 

available toxicity data for clethodim 

have been thoroughly examined for any 

information which suggests a potential 

for neurotoxicity or immunotoxicity. 

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The analysis did not reveal such 

information and the Agency does not 

believe that conducting these studies 

will result in a NOAEL less than the 

currently selected NOAELs for risk 

assessment. Therefore, a database 

uncertainty factor (UFdb) is not needed 

to account for the lack of these studies. 

ii. There is no evidence of 

susceptibility following in utero and/or 

postnatal exposure in the 

developmental toxicity studies in rats or 

rabbits, and in the 2–generation rat 

reproduction study. There are no 

residual uncertainties concerning 

prenatal and postnatal toxicity. 

iii. There is no evidence that 

clethodim is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iv. There are no residual uncertainties 

identified in the exposure data base. 

The chronic dietary food exposure 

assessment utilized tolerance level 

residues for most commodities and 

incorporated average PCT data for some 

commodities. There is no potential for 

residential exposure. The dietary (food 

and drinking water) exposure 

assessment will not underestimate the 

potential exposure for infants, children, 

and/or women of childbearing age. 

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, clethodim 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 clethodim from 

food and drinking water will utilize 

79% of the cPAD for all infants <1 year 

old, the population group receiving the 

greatest exposure. There are no 

residential uses for clethodim. 

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). 

A short-term adverse effect was 

identified; however, clethodim is not 

registered for any use patterns that 

would result in short-term residential 

exposure. Short-term risk is assessed 

based on short-term residential 

exposure plus chronic dietary exposure. 

Because there is no short-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short-term risk), 

no further assessment of short-term risk 

is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term risk for clethodim. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and drinking water 

(considered to be a background 

exposure level). 

An intermediate-term adverse effect 

was identified; however, clethodim is 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

clethodim. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

clethodim is not expected to pose a 

cancer risk to humans. 

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 clethodim 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate plant analytical methods 

are available for tolerance enforcement. 

Method RM-26B-2 (a gas 

chromatography method with flame 

photometric detection in the sulfur 

mode (GC/FPD-S) and the confirmatory 

method RM-26D-2 (a high performance 

liquid chromatography method with 

ultraviolet detection (HPLC/UV) have 

been forwarded to FDA as enforcement 

methods for publication in the 

Pesticides Analytical Manual, Volume II 

(PAM II). Method RM-26B-2 has 

undergone a successful validation in an 

EPA laboratory. Method RM-26B-2 and 

Method RM-26B-3 (a modification of 

Method RM-26B-2) determine the 

combined residues of clethodim and its 

metabolites containing the 2- 

cyclohexen-1-one moiety determined as 

the dimethyl esters of clethodim 

sulfoxide and 5-OH clethodim sulfone 

(DME and DME-OH, respectively) and 

reported as clethodim equivalents. 

A modification of Method RM-26B-3 

(GC/FPD-S) was used for quantitation of 

clethodim residues in/on blueberry, 

caneberry, peach and globe artichoke 

samples from the submitted field trials. 

The method is adequate for data 

collection based on validation data. 

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 

There are no Codex, Canadian, or 

Mexican maximum residue limits 

(MRLs)/tolerances established at this 

time for residues of clethodim in or on 

the commodities receiving tolerances in 

this document. However, Agriculture 

and Agri-Food Canada (AAFC) and IR4 developed residue field trial data for 

blueberry jointly and submitted these 

data to the Pest Management Regulatory 

Agency (PMRA) and EPA. Both PMRA 

and EPA will be establishing MRLs for 

bushberry subgroup 13-07B at the same 

level. 

C. Revisions to Petitioned-For 

Tolerances 

The globe artichoke tolerance is a 

reduction from the proposed 1.3 ppm to 

1.2 ppm based on the tolerance 

spreadsheet summary of clethodim field 

trial data under the Guidance for Setting 

Pesticide Tolerances Based on Field 

Trial Data SOP. 

The recommended bushberry 

subgroup 13-07B tolerance is a 

reduction from the proposed 3.0 ppm to 

0.20 ppm. The 0.20 ppm recommended 

tolerance is based on the lowest level of 

method validation and excludes the 

lowbush blueberry data since the 

lowbush blueberry data were obtained 

by over-the-top foliar spray instead of 

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26678 Federal Register / Vol. 75, No. 91 / Wednesday, May 12, 2010 / Rules and Regulations 

according to the proposed use of spray 

directed at the base of the plants and 

only one study was submitted on lowgrowing berries. 

The paragraph and table in (a)(2) is 

being removed because the tolerances in 

this section have expired. 

The tolerances for lettuce leaf and 

spinach are being removed in paragraph 

(a)(3) as they are covered by the leafy 

greens subgroup 4A. 

The tolerance for flax seed at 0.50 

ppm is being removed in paragraph 

(a)(3) because there is one for flax seed 

at 0.6 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of clethodim, including its 

metabolites and degradates, in or on the 

raw agricultural commodities artichoke, 

globe at 1.2 ppm, bushberry subgroup 

13-07B at 0.20 ppm, caneberry subgroup 

13-07A at 0.30 ppm and peach at 0.20 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: May 4, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.458 is amended as 

follows: 

■ i. Remove paragraph (a)(2); 

■ ii. Redesignate paragraph (a)(3) as 

(a)(2); 

■ iii. Alphabetically add the 

commodities to newly designated 

paragraph (a)(2); 

■ iv. Redesignate paragraph (a)(4) as 

(a)(3); 

■ v. Remove the existing tolerances on 

lettuce leaf, and spinach in newly 

designated paragraph (a)(2); 

■ vi. Remove the tolerance for flax seed 

at 0.50 ppm in newly designated 

paragraph (a)(2). 

The amendments read as follows: 

§ 180.458 Clethodim; tolerances for 

residues. 

(a) General. * * * 

(2) Tolerances are established for the 

combined residues of the herbicide 

clethodim [(E)-(±)-2-[1-[[(3-chloro-2- 

propenyl)oxy]imino]propyl]-5-[2- 

(ethylthio)propyl]-3-hydroxy-2- 

cyclohexen-1-one] and its metabolites 

containing the 5-(2- 

ethylthiopropyl)cyclohexen-3-one and 

5-(2-ethylthiopropyl)-5- 

hydroxycyclohexen-3-one moieties and 

their sulphoxides and sulphones, 

expressed as clethodim tolerance 

residues for the following commodities: 

Commodity Parts per million 

* * * * * 

Artichoke, globe .............. 1.2 

* * * * * 

Bushberry subgroup 13- 

07B .............................. 0.20 

Caneberry subgroup 13- 

07A .............................. 0.30 

* * * * * 

Peach .............................. 0.20 

* * * * * 

* * * * * 

[FR Doc. 2010–11301 Filed 5–11–10; 8:45 am] 

BILLING CODE 6560–50–S 

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