26310 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 

Dated: May 1, 2007. 

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 180.527 is amended as 

follows: 

■ i. By revising the section heading; 

■ ii. By revising paragraph (a); 

■ iii. By removing the text of paragraph 

(b) and reserving with heading; 

■ iv. By revising the introductory text of 

paragraph (c) and adding commodities 

to the table; and 

■ v. By revising the introductory text of 

paragraph (d). 

The amendments read as follows: 

§ 180.527 Flufenacet, N-(4-fluorophenyl)-N- 

(1-methylethyl)-2-[[5-(trifluoromethyl)-1, 3, 

4-thiadiazol-2-yl] oxy]acetamide and its 

metabolites containing the 4-fluoro-Nmethylethyl benzenamine tolerances for 

residues. 

(a) General. Tolerances are 

established for the combined residues of 

the herbicide flufenacet, N-(4- 

fluorophenyl)-N-(1-methylethyl)-2-[[5- 

(trifluoromethyl)-1, 3, 4-thiadiazol-2-yl] 

oxy]acetamide and its metabolites 

containing the 4-fluoro-N-methylethyl 

benzenamine moiety in or on the 

following commodities. 

Commodity Parts per million 

Cattle, kidney ........ 0.05 

Corn, field, forage 0.4 

Corn, field, grain ... 0.05 

Corn, field, stover 0.4 

Corn, sweet, forage .................... 0.45 

Corn, sweet, kernel 

plus cob with 

husks removed .. 0.05 

Corn, sweet, stover 0.30 

Goat, kidney ......... 0.05 

Hog, kidney ........... 0.05 

Horse, kidney ........ 0.05 

Sheep, kidney ....... 0.05 

Soybean, seed ...... 0.1 

Wheat, bran .......... 0.80 

Wheat, forage ....... 6.0 

Wheat, grain ......... 0.60 

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

Wheat, straw ......... 0.35 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. Tolerances are established 

for combined residues of flufenacet, N- 

(4-fluorophenyl)-N-(1-methylethyl)-2- 

[[5-(trifluoromethyl)-1, 3, 4-thiadiazol-2- 

yl] oxy]acetamide, and its metabolites 

containing the 4-fluoro-N-methylethyl 

benzenamine moiety, with regional 

registration. 

Commodity Parts per million 

Grass, forage ........ 7.0 

Grass, hay ............ 0.4 

(d) Indirect or inadvertent residues. 

Tolerances are established for indirect 

or inadvertent residues of the herbicide 

flufenacet, N-(4-fluorophenyl)-N-(1- 

methylethyl)-2-[[5-(trifluoromethyl)- 

1,3,4-thiadiazol-2-yl]oxy]acetamide and 

its metabolites containing the 4-fluoroN-methylethyl benzenamine moiety in 

or on the following raw agricultural 

commodities when present therein as a 

result of application of flufenacet to the 

growing crops in paragraph (a) of this 

section. 

* * * * * 

[FR Doc. E7–8936 Filed 5–8–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0535; FRL–8127–2] 

Clethodim; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

clethodim and certain of its metabolites 

in or on asparagus; flax, seed; herb, 

subgroup 19A; hop, dried cones; leafy 

greens subgroup 4A; safflower, meal; 

safflower, seed; sesame, seed; and 

vegetable, legume, group 6, except 

soybean. 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 

9, 2007. Objections and requests for 

hearings must be received on or before 

July 9, 2007, 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–2005–0535. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

web site to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

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 

telephone number is (703) 305-5805. 

FOR FURTHER INFORMATION CONTACT: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460-0001; telephone number: 

(703) 305-7610; e-mail address: 

jackson.sidney@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), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

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 


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assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, 

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–2005–0535 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before July 9, 2007. 

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–2005–0535, 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’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 telephone number is (703) 305- 

5805. 

II. Petition for Tolerance 

In the Federal Register of April 21, 

2006 (71 FR 20669) (FRL–8056–8), EPA 

issued a notice pursuant to section 

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

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

pesticide petitions (PP 3E6555, 5E6977, 

4E6836, 5E6978, and 4F6895) by the 

Interregional Research Project #4 (IR-4), 

500 College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.458 be 

amended by establishing a tolerance 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 2-cyclohexene-1-one 

moiety in or on flax, seed at 0.5 parts 

per million (ppm) (PP 3E6555); herb, 

subgroup 19A at 10.0 ppm (4E6836); 

asparagus at 2.0 ppm and hop, dried 

cones at 0.5 ppm (5E6977); leafy greens 

subgroup 4A at 2.0 ppm (5E6978); and 

sesame, seed at 0.40 ppm; vegetable, 

legume, group 6 at 3.0 ppm; safflower, 

meal at 10.0 ppm; and safflower, seed at 

5.0 ppm (4F6895). That notice 

referenced a summary of the petitions 

prepared by Valent U.S.A. Corporation, 

133 N. California Blvd., Walnut Creek, 

CA 94596, the registrant, which is 

available to the public in the docket, 

http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

recommended certain changes to the 

petitions including: 

• Revised tolerance levels for certain 

commodities, and: 

• A specific tolerance expression to 

be applied to all new uses in an effort 

to harmonize tolerances with Codex 

Maxium Residue Limits. The reasons for 

these changes are explained in Unit V. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . . .’’ These 

provisions were added to the FFDCA by 

the Food Quality Protection Act (FQPA) 

of 1996. 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

section 408(b)(2)(D), EPA has reviewed 

the available scientific data and other 

relevant information in support of this 

action. EPA has sufficient data to assess 

the hazards of and to make a 

determination on aggregate exposure for 

the petitioned for tolerances for 

combined residues of clethodim on flax, 

seed at 0.6 ppm; herb, subgroup 19A at 

12.0 ppm (4E6836); asparagus at 1.7 

ppm and hop, dried cones at 0.5 ppm; 

leafy greens subgroup 4A at 2.0 ppm 

(5E6978); and sesame, seed at 0.35 ppm; 

vegetable, legume (except soybean), 

group 6 at 3.5 ppm; safflower, meal at 

10.0 ppm; and safflower, seed at 5.0 

ppm. EPA’s assessment of exposures 

and risks associated with establishing 

the tolerance follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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 clethodim as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http:// 

www.regulations.gov. The referenced 

document is available in the docket 

established by this action, which is 

described under ADDRESSES, and is 

identified as ‘‘Clethodim: Human Health 

Risk Assessment for Proposed Uses on 

Herb Sugbroup 19A, Leafy 

Greens......and Flax seed, dated 03/07/ 

2007’’ in that docket. 


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Additionally, clethodim toxicological 

data are discussed in the final rule 

published in the Federal Register of 

March 14, 2001(66 FR 14829) (FRL–

6770–8). 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the toxicological level of concern 

(LOC) is derived from the highest dose 

at which NOAELs are observed in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the LOAEL of concern 

identified is sometimes used for risk 

assessment. Uncertainty/safety factors 

(UF) are used in conjunction with the 

LOC to take into account uncertainties 

inherent in the extrapolation from 

laboratory animal data to humans and in 

the variations in sensitivity among 

members of the human population as 

well as other unknowns. Safety is 

assessed for acute and chronic risks by 

comparing aggregate exposure to the 

pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the LOC by all applicable 

uncertainty/safety factors. Short-term, 

intermediate-term, and long-term risks 

are evaluated by comparing aggregate 

exposure to the LOC to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable 

uncertainty/safety factors is not 

exceeded. 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk and 

estimates risk in terms of the probability 

of occurrence of additional adverse 

cases. Generally, cancer risks are 

considered non-threshold. 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/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

A summary of the toxicological 

endpoints for clethodim used for human 

risk assessment can be found at 

www.regulations.gov in document 

‘‘Clethodim: Human Health Risk 

Assessment for Proposed Uses on Herb 

Sugbroup 19A, Leafy Greens......and 

Flax seed, dated 03/07/2007’’ at page 14 

in Docket ID EPA–HQ–OPP–2005–0535. 

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 (food and water) 

exposure assessment, EPA used the food 

consumption data from the U.S. 

Department of Agriculture’s (USDA) 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII) from 1994- 

1996 and 1998. The chronic dietary 

exposure assessment was based on the 

assumption of tolerance-level residues 

for existing and proposed tolerances; 

and incorporated percent crop treated 

(PCT) information for certain registered 

uses. 

iii. Cancer. Clethodim was negative 

for carcinogenicity in feeding studies in 

rats and mice and was classified as ‘‘not 

likely’’ to be a human carcinogen. 

Therefore, a quantitative exposure 

assessment to evaluate cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. 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: 

a. The data used are reliable and 

provide a valid basis to show what 

percentage of the food derived from 

such crop is likely to contain such 

pesticide residue; 

b. The exposure estimate does not 

underestimate exposure for any 

significant subpopulation group; and 

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 used PCT information as 

follows: 

Commodity Percent of Crop Treated (Weighted Average) 

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 


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Commodity Percent of Crop Treated (Weighted Average) 

Potatoes 5 

Pumpkins 5 

Soybeans 5 

Squash 5 

Strawberries 1 

Sugar beets 45 

Sunflowers 20 

Sweet potatoes 1 

Tomatoes 1 

Watermelons 5 

EPA uses an average PCT for chronic 

dietary risk analysis. The average PCT 

figure for each existing use is derived by 

combining available federal, state, and 

private market survey data for that use, 

averaging by year, averaging across all 

years, and rounding up to the nearest 

multiple of five percent except for those 

situations in which the average PCT is 

less than one. In those cases <1% is 

used as the average and <2.5% is used 

as the maximum. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the single 

maximum value reported overall from 

available federal, state, and private 

market survey data on the existing use, 

across all years, and rounded up to the 

nearest multiple of five percent. In most 

cases, EPA uses available data from 

USDA/National Agricultural Statistics 

Service (NASS), Proprietary Market 

Surveys, and the National Center for 

Food and Agriculture Policy (NCFAP) 

for the most recent six years. 

The Agency believes that the three 

conditions listed above have been met. 

With respect to Condition 1, PCT 

estimates are derived from sources as 

discussed above including 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 2 and 3, 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 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 lacks sufficient 

monitoring data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

clethodim in drinking water. Because 

the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the environmental fate 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. 

Surface water and ground water 

contamination may occur from the 

sulfoxide and sulfone degradates of 

clethodim, as well as from parent 

clethodim. However, the risk of water 

contamination is primarily associated 

with clethodim sulfone and clethodim 

sulfoxide rather than parent clethodim 

based on greater persistence and 

mobility for these degradates. Parent 

clethodim may move from the treated 

field to surface water or ground water 

through run-off or leaching which 

occurs shortly after application (e.g. 

rainfall). Also, the sulphoxide and 

sulphone degradates may migrate by 

runoff or leaching for longer periods of 

time since they are more persistent. All 

residues of clethodim (parent and 

degradates) are very mobile in soil. 

The only significant routes of 

dissipation of clethodim are microbial 

degradation in soil and movement by 

leaching or runoff. Parent clethodim is 

moderately persistent to hydrolysis at 

pH 5 with half-lives of 26-42 days and 

stable at pH 7 and 9 with half-lives 

greater than 300 days. Even though 

acceptable water and soil photolysis 

studies show half-lives of 1.5 to 9.3 

days, this may not be an important route 

of dissipation because of suspended 

sediment and shading. Photolysis is 

only an important route of dissipation 

in shallow, well-mixed surface water 

with no shading. The half-lives in 

aerobic soil are 2-3 days for parent 

clethodim, and 30-38 days for total toxic 

residues (parent + sulphoxide + 

sulphone). The sulphoxide and 

sulphone metabolites are more 

persistent than parent clethodim and are 

formed in significant quantities in soil. 

All residues of clethodim (parent and 

metabolites) are very mobile in soil with 

five out of six soil desorption 

coefficients (Kd) less than one. The field 

dissipation studies show that parent 

clethodim was only found at levels at or 

near the quantitation limit of 0.02 ppm, 

which is consistent with the rapid 

degradation in soil. Clethodim 

sulphoxide had an apparent half-life of 

2.5 to 3.7 days, indicating that 

movement from the treated field may 

have been an important route of 

dissipation. 

In surface water, parent clethodim 

may move from the treated field to 

surface water or ground water through 

run-off or leaching which occurs shortly 

after application (e.g. rainfall). Also, the 

sulphoxide and sulphone degradates 

may migrate by runoff or leaching for 

longer periods of time since they are 


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more persistent. All residues of 

clethodim (parent and degradates) are 

very mobile in soil. 

In ground water, parent clethodim is 

mobile, but has a short metabolic halflife in soil under aerobic conditions. 

Therefore, parent compound should not 

be a ground water concern in most 

environments. While it is expected that 

parent clethodim can be transformed to 

sulphoxide or sulphone products 

quickly by soil metabolism (tc = 1 - 3 

days), it may be more persistent since it 

is leached below the more biologically 

active top soil. In such instances (i.e., 

leaching rainfall shortly after 

application) parent clethodim 

concentrations may be higher than 

estimated and correspondingly, the 

concentration of the degradates 

sulphoxide and sulphone would be 

lower. In the event that parent 

clethodim did reach ground water, the 

available routes of disappearance would 

be dilution, some metabolism to 

persistent degradates, and slow 

hydrolysis with the rate depending on 

the pH of the ground water. Estimates 

are provided for both parent clethodim 

and total toxic clethodim (parent + 

sulphoxide + sulphone). 

Based on the (FQPA Index Reservoir 

Screening Tool (FIRST)) model, Tier 1 

surface water concentrations for parent 

clethodim and total toxic residues 

(parent + sulphoxide + sulphone) were 

estimated in drinking water. These 

estimates are based on a maximum 

application rate of 0.5 lb ai/acre per year 

(2 applications). The peak FIRST 

estimated environmental concentration 

(EEC) for clethodim and it’s degradates, 

sulphoxide and sulphone for acute 

exposures are estimated to be 38.9 parts 

per billion (ppb) for surface water. The 

EECs for chronic exposures are 

estimated to be 7.6 ppb for surface 

water. For drinking water derived from 

ground water, the Screening 

Concentration in Ground water (SCIGROW) model estimates a total toxic 

clethodim concentration of 1.39 ug/L 

sources were not included, as the EEC’s 

for this water source are minimal in 

comparison to surface water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 38.9 ppb was 

used to access the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 7.6 ppb was used to access 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). 

Although clethodim is registered for 

use in non-crop areas and for 

commercial use on ornamentals, no 

residential exposure is expected from 

these uses because these uses are clearly 

intended for commercial and 

institutional applications on 

commercially grown ornamentals and 

not for ornamentals in a residential 

setting. Therefore, non-occupational 

exposure assessment of clethodim was 

not performed. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the 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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

clethodim and 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 not 

assumed that clethodim has 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 the policy statements released by 

EPA’s Office of Pesticide Programs 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional (10X) tenfold 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 data based 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. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional FQPA 

safety factor value based on the use of 

traditional uncertainty/safety factors 

and/or special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

There is no evidence of susceptibility 

following in utero and/or postnatal 

exposure to clethodim in the 

developmental toxicity studies in rats or 

rabbits, and in the 2-generation rat 

reproduction study. 

There are no residual uncertainties 

concerning pre- and postnatal toxicity 

and no neurotoxicity concerns. 

3. Conclusion. EPA has determined 

that reliable data show that it would be 

safe for infants and children to reduce 

the FQPA safety factor to 1X. That 

decision is based on the following 

findings: 

i. The toxicity data base for clethodim 

is complete. 

ii. There is no indication that 

clethodim is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional 

uncertainty factors to account for 

neurotoxicity. 

iii. There is no evidence that 

clethodim results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the two-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary (food and drinking water) 

exposure assessment will not 

underestimate the potential exposure for 

infants, children, and/or women of 

childbearing age. There is no potential 

for residential exposure. 

E. Aggregate Risks and Determination of 

Safety 

Safety is assessed for acute and 

chronic risks by comparing aggregate 

exposure to the pesticide to the aPAD 

and cPAD). The aPAD and cPAD are 

calculated by dividing the LOC by all 

applicable uncertainty/safety factors. 

For linear cancer risks, EPA calculates 

the probability of additional cancer 

cases given aggregate exposure. Shortterm, intermediate, and long-term risks 

are evaluated by comparing aggregate 

exposure to the LOC to ensure that the 

margin of exposure MOE called for by 

the product of all applicable 

uncertainty/safety factors is not 

exceeded. 

1. Acute risk. 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). 


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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 exposure to clethodim from food 

and water will utilize 29% of the cPAD 

for the general U.S. population group 

and 84% of the cPAD for children 1-2 

years old, the subpopulation group with 

greatest exposure. There are no 

residential uses for clethodim that result 

in chronic residential exposure to 

clethodim. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Clethodim is not registered for use on 

any sites that would result in residential 

exposure. Therefore, the aggregate risk 

is the sum of the risk from food and 

water which do not exceed the Agency’s 

level of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Clethodim is not registered for use on 

any sites that would result in residential 

exposure. Therefore, the aggregate risk 

is the sum of the risk from food and 

water, which do not exceed the 

Agency’s level of concern. 

5. Aggregate cancer risk for U.S. 

population. Clethodim is classified as a 

‘‘not likely’’ to be carcinogenic in 

humans based on the results of a 

carcinogenicity study in mice and the 

combined chronic toxicity and 

carcinogenicity study in the rat. 

Therefore, 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 

For plants, adequate methodology is 

available for enforcement of the 

proposed tolerances through the use of 

FDA Multiresidue Methods. The 

analytical method used to assay 

clethodim residues in/on commodities 

that are the subject of this action was 

RM-26B-3 (a modification of RM-26B-2) 

or RE 45601 (also adapted from Valent 

(the registrant) method RM-26B), which 

was validated for the analyses of 

residues of clethodim sulfoxide and its 

metabolite (5-hydroxy clethodim 

sulfone) in/on green onions, leaf lettuce, 

and cabbage. Samples were analyzed for 

combined clethodim residues 

(dimethylester sulfone (DME) and 5- 

hydroxy dimethylester sulfone (DMEOH)) by gas chromatography with flame 

photometric detection in the sulfur 

mode (GC/FPD-S). In the analytical 

results, DME and DME-OH were 

reported as clethodim equivalents. Only 

one crop, hops, dried cones, had 

residues below the limit of quantitation 

(LOQ) <0.50 ppm) for combined total 

residues of clethodim (DME and DMEOH). The concurrent recoveries of 

clethodim (DME and DME-OH) for the 

submitted trials were generally within 

the accepted range of 70-120%. An 

exception was the concurrent recovery 

of DME-OH in succulent pea at 62%. 

There is no reason to believe that the 

residues of clethodim were unstable, or 

that the analytical method was not 

reliable under the conditions of these 

studies. 

For livestock, Analytical Method RM26B-3 (a modification of RM-26B-2) has 

been successfully validated for use with 

livestock commodities and has been 

submitted to the FDA for publication in 

PAM II. 

IR-4 (petitioner) has previously 

submitted data describing the testing of 

clethodim and its metabolites through 

FDA Multiresidue Methods. These data, 

which have been forwarded to FDA for 

review indicate that adequate recoveries 

of clethodim, clethodim sulphoxide, 

and 5-OH clethodim sulphone have 

been obtained under FDA’s 

multiresidue protocols. 

Accordingly, EPA concludes that 

Adequate enforcement methodology 

(GC/FPD-S) 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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are currently Codex MRLs 

established for clethodim and its 

metabolites containing 5-(2- 

ethylthiopropyl)cyclohexene-3-one and 

5-(2-ethylthiopropyl)-5- 

hydroxycyclohexene-3-one moieties and 

their sulphoxides and sulphones, 

expressed as clethodim, in or on bean, 

dry at 2 ppm; beans, except broad bean 

and soya bean at 0.5 ppm; field peas 

(dry) at 2 ppm; and soya bean (dry) at 

10 ppm. Based on newly submitted field 

trial data, the Agency is establishing a 

new crop group tolerance, i.e., on 

vegetables, legume, group (crop group 

6), except soybean. Because the Agency 

is establishing the tolerances on legume 

vegetables as a crop group, it cannot 

harmonize the crop group tolerance 

with the varying Codex MRLs for 

individual legume vegetables. 

There are established Canadian MRLs 

for clethodim residues and its 

metabolites containing the 2-cyclohex-1- 

enone moiety on soybean at 10.0 ppm, 

beans, 0.5, chickpea at 0.5 ppm; lentils 

at 0.5 ppm; pea, dry at 0.5 ppm and flax 

seed at 0.3 ppm. In addition, Mexican 

MRLs are established for clethodim on 

bean, kidney at 2.0 ppm and soya bean 

at 10 ppm. Harmonization with 

Canadian and Mexican MRLs is not 

possible based on the MRL calculations 

of the newly submitted data. 

V. Conclusion 

The Agency has revised the proposed 

tolerance expression to make it 

consistent with the existing tolerance 

expression in 40 CFR 180.458 (a)(3). 

Clethodim is defined as the combined 

residues of clethodim 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. In 

addition, the Agency revised tolerance 

levels proposed by IR-4 for certain 

commodities to reflect tolerance levels 

supported by current data bases. 

Therefore, 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 in or 

on flax, seed at 0.6 ppm; herb, subgroup 

19A at 12.0 ppm; asparagus at 1.7 ppm; 

hop, dried cones at 0.5 ppm; leafy 

greens subgroup 4A at 2.0 ppm; and 

sesame, seed at 0.35 ppm; vegetable, 

legume group 6, except soybean at 3.5 

ppm; safflower, meal at 10.0 ppm; and 

safflower, seed at 5.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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 rule has 

been exempted from review under 

Executive Order 12866, this rule is not 


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26316 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 

subject to Executive Order 13211, 

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 6, 2000) do not apply 

to this rule. In addition, This 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 1, 2007. 

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 by 

alphabetically adding the following 

commodities to the table in paragraph 

(a)(3) to read as follows: 

§ 180.458 Clethodim; tolerances for 

residues. 

(a) * * *

(3) * * * 

Commodity Parts per million 

Asparagus ............................................................................................................................................................................ 1.7 

*****

Flax seed ............................................................................................................................................................................. 0.6 

*****

Herb subgroup 19A ............................................................................................................................................................. 12.0 

*****

Hop, dried cones ................................................................................................................................................................. 0.5 

*****

Leafy greens subgroup 4A .................................................................................................................................................. 2.0 

*****

Safflower, meal .................................................................................................................................................................... 10.0 

Safflower, seed .................................................................................................................................................................... 5.0 

Sesame, seed ...................................................................................................................................................................... 0.35 

*****

Vegetable, legume group 6, except soybean ...................................................................................................................... 3.5 

* * * * * 

[FR Doc. E7–8938 Filed 5–8–07; 8:45 am] 

BILLING CODE 6560–50–S 


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