Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations 30325

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

For these same reasons, the Agency has

determined that this rule does not have

any tribal implications as described in

Executive Order 13175, entitled

Consultation and Coordination with

Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

meaningful and timely input by tribal

officials in the development of

regulatory policies that have tribal

implications. Policies that have tribal

implications is defined in the Executive

Order to include regulations that have

substantial direct effects on one or more

Indian tribes, on the relationship

between the Federal government and

the Indian tribes, or on the distribution

of power and responsibilities between

the Federal government and Indian

tribes. This rule will not have

substantial direct effects on tribal

governments, on the relationship

between the Federal government and

Indian tribes, or on the distribution of

power and responsibilities between the

Federal government and Indian tribes,

as specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.

XI. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, 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 18, 2001.

Marcia E. Mulkey,

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), 346(a) and

371.

2. Section 180.1217 is added to

subpart D to read as follows:

§ 180.1217 Bacillus thuringiensis Cry1F

Protein and the Genetic Material Necessary

for its Production in Corn; exemption from

the requirement of a tolerance.

Bacillus thuringiensis Cry1F protein

and the genetic material necessary for

its production in corn are exempt from

the requirement of a tolerance when

used as plant-pesticides in the food and

feed commodities of field corn, sweet

corn and popcorn. ‘‘Genetic material

necessary for its production’’ means the

genetic material which comprise:

genetic material encoding the Cry1F

protein and its regulatory regions.

‘‘Regulatory regions’’ are the genetic

material, such as promoters,

terminators, and enhancers, that control

the expression of the genetic material

encoding the Cry1F protein.

[FR Doc. 01–13837 Filed 6–5–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301134; FRL–6785–5]

RIN 2070–AB78

Clethodim; Time-Limited Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues/

combined residues of clethodim in or on

alfalfa forage, alfalfa hay, dry beans,

peanut hay, peanut meal, peanuts,

tomato paste, and tomato puree. Valent

U.S.A. Corporation requested this

tolerance under the Federal Food, Drug,

and Cosmetic Act, as amended by the

Food Quality Protection Act of 1996.

The tolerance will expire on April 30,

2003.

DATES: This regulation is effective June

6, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301134 must be received

by EPA on or before August 6, 2001.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI.. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301134 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne I. Miller, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–6224; and e-mail

address: miller.joanne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have 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 Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

30326 Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. To access the

OPPTS Harmonized Guidelines

referenced in this document, go directly

to the guidelines at http://www.epa.gov/

opptsfrs/home/guidelin.htm. A

frequently updated electronic version of

40 CFR part 180 is available at http://

www.access.gpo.gov/nara/cfr/

cfrhtml_180/Title_40/40cfr180_00.html,

a beta site currently under development.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301134. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of March 28,

2001 (66 FR 16931) (FRL–6773–5), EPA

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 U.S.C. 346a as

amended by the Food Quality Protection

Act of 1996 (FQPA) (Public Law 104–

170) announcing the filing of pesticide

petitions (PP 5F4440 and 5F4572) for

tolerance by Valent U.S.A. Corporation,

1333 N. California Blvd., Ste. 600,

Walnut Creek, CA 94596–8025. This

notice included a summary of the

petitions prepared by Valent U.S.A.

Corporation, the registrant. There were

no comments received in response to

the notice of filing.

The petitions requested that 40 CFR

180.458 be amended by extending timelimited 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-

ethylthiopropyl)cyclohexene-3-one and

5-(2-(ethylthiopropyl)-5-

hydroxycyclohexene-3-one moieties and

their sulphoxides and sulphones,

expressed as clethodim, in or on alfalfa

forage at 6 parts per million (ppm),

alfalfa hay at 10 ppm, dry beans at 2

ppm, peanut hay at 3 ppm, peanut meal

at 5 ppm, peanuts at 3 ppm, tomato

paste at 3 ppm, and tomato puree at 2

ppm. Time-limited tolerances on these

commodities are extended to allow EPA

sufficient time to evaluate new residue

data for these commodities. Valent

U.S.A. Corporation is not proposing to

extend the time-limited tolerance for

residues on tomatoes at 1.0 ppm

because tolerances are issued for

residues on fruiting vegetables (except

cucurbits), which includes tomatoes, at

1.5 ppm. The tolerances will expire on

April 30, 2003.

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) 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) 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....’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. For

further discussion of the regulatory

requirements of section 408 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997) (FRL–5754–

7).

III. Aggregate Risk Assessment and

Determination of Safety

Consistent with 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, consistent with

section 408(b)(2), for a tolerance for

combined residues of clethodim on

alfalfa forage at 6 ppm, alfalfa hay at 10

ppm, dry beans at 2 ppm, peanut hay at

3 ppm, peanut meal at 5 ppm, peanuts

at 3 ppm, tomato paste at 3 ppm, and

tomato puree at 2 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 its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by clethodim are

discussed in the following Table 1 as

well as the no observed adverse effect

level (NOAEL) and the lowest observed

adverse effect level (LOAEL) from the

toxicity studies reviewed.

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline

Number Study Type Results

870.3100 Subchronic-Feeding-Rat NOAEL= 25 mg/kg/day

LOAEL= 134 mg/kg/day based on decreased body weights, body weight gains, food consumption, and increased absolute and relative liver weights, and centrilobular hypertrophy of liver in

both sexes.

870.3150 Subchronic-Feeding-Dog NOAEL= 25 mg/kg/day

Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations 30327

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued

Guideline

Number Study Type Results

LOAEL= 75 mg/kg/day based on increased absolute and relative liver weights, severity of liver

lesions in both sexes, and increased serum cholesterol and alkaline phosphatase in females.

870.3200 21–Day Dermal Toxicity-Rat Systemic NOAEL= 100 mg/kg/day

LOAEL= 1000 mg/kg/day based on anogenital discharge and staining in both sexes, decreased

food efficiency and body weight gain in males, and increases in absolute and relative liver

weights in females.

Dermal NOAEL= not established.

LOAEL= 10 mg/kg/day based on observed dermal irritation.

870.3700 Developmental Toxicity-Rat Maternal NOAEL= 100 mg/kg/day

LOAEL= 350 mg/kg/day based on decreased body weight gain and clinical signs.

Developmental NOAEL= 100 mg/kg/day

LOAEL= 350 mg/kg/day based on decreased fetal body weight and increased skeletal anomalies.

870.3700 Developmental Toxicity-RabbitMaternal NOAEL= 25 mg/kg/day

LOAEL= 100 mg/kg/day based on decreased weight gain and food consumption and clinical

signs.

Developmental NOAEL ≥ ≤ 300 mg/kg/day

LOAEL= Not determined because no developmental toxicity observed.

870.3800 Reproductive Toxicity- 2

Generation Rat

Parental/Systemic NOAEL= 51 mg/kg/day

LOAEL= 263 mg/kg/day based on decreased body weight in both sexes, and particularly in both

generations of males, decreased food consumption.

Reproductive NOAEL= 263 mg/kg/day (highest dose tested)

LOAEL= Not determined because no effects were noted for fertility, length of gestation or

growth and development of offspring.

Offspring NOAEL= 263 mg/kg/day (highest dose tested)

LOAEL= Not determined (see above).

870.4100 Chronic-Feeding-Dog NOAEL= 1 mg/kg/day

LOAEL= 75 mg/kg/day based on increased absolute and relative liver weights in both sexes

with histopathological changes (males only) and increased liver enzymes.

870.4200 Carcinogenicity-Mouse (78–

week)

NOAEL= 30 mg/kg/day

LOAEL= 150 mg/kg/day based on decreased survival, decreased hematology parameters, increased absolute and relative liver weights (female only), centrilobular hypertrophy, increased

pigment and bile duct hyperplasia in both sexes. No evidence of carcinogenicity.

870.4300 Chronic Toxicity/Carcinogenicity-RatNOAEL= 19 mg/kg/day

LOAEL= 100 mg/kg/day based on decreased body weight means, body weight gains, food consumption, and food efficiency (males only), and increased absolute and relative liver weights

with centrilobular hypertrophy (at 12 months) in both sexes. No evidence of carcinogenicity.

870.5100 Gene Mutation - Salmonella Negative for reverse mutation in Salmonella (and E. coli) exposed to cytotoxic levels (10,000 μg/

plate) with/without activation.

870.5300 CHO Assay Positive for inducing structural aberrations only in the absence of activation (negative +S9) at

dose near limit of solubility and cytotoxicity (1.0 to 1.2 μL/ml).

870.5395 Micronucleus Assay Negative for chromosomal damage in bone marrow cells of rats treated orally up to toxic doses

(1,500 mg/kg).

870.5550 Unscheduled DNA Synthesis Negative for unscheduled DNA synthesis (UDS) in hepatocytes from mice treated orally up to

toxic doses (5,000 mg/kg).

870.7485 Metabolism Rat Clethodim is readily absorbed and eliminated (87–92%, urine; 9–17%, feces; ≤ 1% expired air)

after 7 days. Gastrointestinal absorption estimated at 89–96%. No evidence of bioconcentration. Extensively metabolized with < 1% eliminated as unchanged parent compound. Predominant metabolite is clethodim sulphoxide (48–68%) after 48 hours.

870.7600 Dermal Absorption Rat At 10 hours after receiving a single dermal application of 0.05 mg/rat the dermal absorption factor was 30%.

30328 Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations

B. Toxicological Endpoints

The dose at which no adverse effects

are observed (the NOAEL) from the

toxicology study identified as

appropriate for use in risk assessment is

used to estimate the toxicological level

of concern (LOC). However, the lowest

dose at which adverse effects of concern

are identified (the LOAEL) is sometimes

used for risk assessment if no NOAEL

was achieved in the toxicology study

selected. An uncertainty factor (UF) is

applied to reflect 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. An UF of 100 is

routinely used, 10X to account for

interspecies differences and 10X for

intra species differences.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD) where

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA Safety

Factor.

For non-dietary risk assessments

(other than cancer) the UF is used to

determine the LOC. For example, when

100 is the appropriate UF (10X to

account for interspecies differences and

10X for intraspecies differences) the

LOC is 100. To estimate risk, a ratio of

the NOAEL to exposures (margin of

exposure (MOE) = NOAEL/exposure) is

calculated and compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q* is calculated and used to estimate

risk which represents a probability of

occurrence of additional cancer cases

(e.g., risk is expressed as 1 x 10-6 or one

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment. In this non-linear approach,

a ‘‘point of departure’’ is identified

below which carcinogenic effects are

not expected. The point of departure is

typically a NOAEL based on an

endpoint related to cancer effects

though it may be a different value

derived from the dose response curve.

To estimate risk, a ratio of the point of

departure to exposure (MOEcancer = point

of departure/exposures) is calculated. A

summary of the toxicological endpoints

for clethodim used for human risk

assessment is shown in the following

Table 2:

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CLETHODIM FOR USE IN HUMAN RISK ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF

FQPA SF* and Level of

Concern (LOC) for Risk

Assessment

Study and Toxicological Effects

Acute Dietary All PopulationsN/A N/A 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 risk assessment.

Chronic Dietary All populationsNOAEL= 1.0 mg/kg/day;

UF = 100; Chronic RfD =

0.01 mg/kg/day

FQPA SF = 1; cPAD

=chronic RfD/FQPA SF

= 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.

Short-Term Dermal (1 to 7

days) (Residential)

Oral study Maternal

NOAEL= 100 mg/kg/day

(dermal absorption rate

= 30%)

LOC for MOE = 100 (Residential)Developmental Toxicity-Rat.

LOAEL = 350 mg/kg/day based on decreased body

weight gain and clinical signs of toxicity (salivation).

Intermediate-Term Dermal

(1 week to several

months) (Residential)

Oral study NOAEL= 25

mg/kg/day (dermal absorption rate = 30%)

LOC for MOE = 100 (Residential)Subchronic Toxicity-Dog (90 days).

LOAEL = 75 mg/kg/day based on increased absolute

and relative liver weights.

Long-Term Dermal (several

months to lifetime) (Residential)

Oral study NOAEL= 1.0

mg/kg/day (dermal absorption rate = 30%)

LOC for MOE =100 (Residential)Chronic Toxicity-Dog (1 year).

LOAEL = 75 mg/kg/day based on alterations in hematology and clinical chemistry parameters as well as

increases in absolute and relative liver weights.

Short-Term Inhalation (1 to

7 days) (Residential)

Oral study Maternal

NOAEL= 100 mg/kg/day

(inhalation absorption

rate = 100%)

LOC for MOE =100 (Residential)Developmental-Rat

LOAEL = 350 mg/kg/day based on decreased body

weight gain and clinical signs of toxicity (salivation).

Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations 30329

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CLETHODIM FOR USE IN HUMAN RISK

ASSESSMENT—Continued

Exposure Scenario Dose Used in Risk Assessment, UF

FQPA SF* and Level of

Concern (LOC) for Risk

Assessment

Study and Toxicological Effects

Intermediate-Term Inhalation

(1 week to several

months) (Residential)

Oral study NOAEL = 25

mg/kg/day (inhalation

absorption rate = 100%)

LOC for MOE = 100 (Residential)Subchronic Toxicity-Dog (90 days).

LOAEL = 75 mg/kg/day based on increased absolute

and relative liver weights.

Long-Term Inhalation (several months to lifetime)

(Residential)

Oral study NOAEL= 1.0

mg/kg/day (dermal absorption rate = 30%)

LOC for MOE =100 (Residential)Chronic Toxicity-Dog (1 year).

LOAEL = 75 mg/kg/day based on alterations in hematology and clinical chemistry parameters as well as

increases in absolute and relative liver weights.

Cancer (oral, dermal, inhalation)N/A N/A Clethodim is classified as a ‘‘Not Likely’’ carcinogen

* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.458) for the

combined residues of clethodim, in or

on a variety of raw agricultural

commodities. Tolerances are established

on fat, meat, and meat by products

(mbyp) of cattle, goats, hogs, horses,

poultry, and sheep at 0.20 ppm, milk at

0.05 ppm, eggs at 0.20 ppm, carrots at

0.50 ppm, cranberry at 0.50 ppm, clover

forage at 10.0 ppm, clover hay at 20.0

ppm, cottonseed at 1.0 ppm, cottonseed

meal at 2.0 ppm, fruiting vegetable

group at 1.0 ppm, leaf petioles subgroup

at 0.60 ppm, melon subgroup at 2.0

ppm, potatoes at 0.5 ppm, potato flakes

and granules at 2.0 ppm, radish roots at

0.50 ppm, radish tops at 0.70 ppm,

squash/cucumber subgroup at 0.50 ppm,

strawberry at 3.0 ppm, sunflower meal

at 10.0 ppm, sunflower seed at 5.0 ppm,

soybeans at 10.0 ppm, soybean

soapstock at 15.0 ppm, dry bulb onions

at 0.20 ppm, sugar beet roots at 0.20

ppm, sugar beet tops at 1.0 ppm, sugar

beet molasses at 1.0 ppm, and tuberous

and corm vegetables at 1.0 ppm. Risk

assessments were conducted by EPA to

assess dietary exposures from clethodim

in food as follows:

i. Acute exposure. Acute dietary risk

assessments are performed for a fooduse pesticide if a toxicological study has

indicated the possibility of an effect of

concern occurring as a result of a one

day or single exposure. An endpoint

was not identified for acute dietary

exposure and risk assessment because

no effects were observed in oral toxicity

studies including developmental

toxicity studies in rats or rabbits that

could be attributable to a single dose

(exposure). Therefore, an acute dietary

exposure assessment was not

performed.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

Dietary Exposure Evaluation Model

(DEEM) analysis evaluated the

individual food consumption as

reported by respondents in the USDA

1989–1992 nationwide Continuing

Surveys of Food Intake by Individuals

(CSFII) and accumulated exposure to

the chemical for each commodity. The

following assumptions were made for

the chronic exposure assessments: The

3–day average of consumption for each

sub-population is combined with

residues to determine average exposure

as mg/kg/day. The chronic analysis was

performed using tolerance level residues

for all crops and animal commodities.

The weighted average percent of crop

treated data for existing registrations,

and 100% crop treated (CT) data (for

new uses) were used for the analyses.

iii. Cancer. Clethodim has been

classified as a group E carcinogen.

Therefore, a cancer risk assessment is

not required.

Section 408(b)(2)(F) states that the

Agency may use data on the actual

percent of food treated for assessing

chronic dietary risk only if the Agency

can make the following findings:

Condition 1, that 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;

Condition 2, that the exposure estimate

does not underestimate exposure for any

significant subpopulation group; and

Condition 3, if 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 percent crop treated

(PCT) as required by section

408(b)(2)(F), EPA may require

registrants to submit data on PCT.

The Agency used percent crop treated

(PCT) information as follows:

3% for cotton, 8% for onions, 3% for

peanuts, 4% for soybeans, 15% for sugar

beets, and 1% for tomatoes

The Agency believes that the three

conditions listed above have been met.

With respect to Condition 1, PCT

estimates are derived from Federal and

private market survey data, which are

reliable and have a valid basis. EPA uses

a weighted average PCT for chronic

dietary exposure estimates. This

weighted average PCT figure is derived

by averaging State-level data for a

period of up to 10 years, and weighting

for the more robust and recent data. A

weighted average of the PCT reasonably

represents a person’s dietary exposure

over a lifetime, and is unlikely to

underestimate exposure to an individual

because of the fact that pesticide use

patterns (both regionally and nationally)

tend to change continuously over time,

such that an individual is unlikely to be

exposed to more than the average PCT

over a lifetime. For acute dietary

exposure estimates, EPA uses an

estimated maximum PCT. The exposure

estimates resulting from this approach

reasonably represent the highest levels

to which an individual could be

exposed, and are unlikely to

underestimate an individual’s acute

dietary exposure. The Agency is

reasonably certain that the percentage of

the food treated is not likely to be an

30330 Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations

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. Known environmental

characteristics of clethodim depict a

compound which is stable to hydrolysis,

except in acid conditions, but highly

susceptible to photolysis and

metabolism.

Parent clethodim is mobile, but has a

short metabolic half-life of 1–3 days in

soil under aerobic conditions.

Therefore, parent compound should not

be a ground water concern in most

environments. 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.

The environmental fate data indicate

that clethodim, and its sulphoxide and

sulphone metabolites may migrate into

surface water bodies through run-off

which occurs shortly after application

(e.g. rainfall). Since they are not

adsorbed readily to soil (Kds of < 0.1 to

7) , they are likely to remain in the

aqueous phase, where they are subject

to rapid photolysis and biodegradation.

They may remain long enough to exert

acute effects on resident biota, but are

unlikely to cause chronic effects.

Clethodim does not show a significant

potential for bio-accumulation in

aquatic organisms. Although they have

been individually tested, the primary

degradates are highly polar, and would

not be expected to bio-accumulate.

The Agency lacks sufficient

monitoring exposure 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 physical characteristics of

clethodim.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and SCIGROW, which predicts pesticide

concentrations in groundwater. In

general, EPA will use GENEEC (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model) for a screening-level

assessment for surface water. The

GENEEC model is a subset of the PRZM/

EXAMS model that uses a specific highend runoff scenario for pesticides.

GENEEC incorporates a farm pond

scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models include

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever exceed human health levels of

concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a %RfD or %PAD.

Instead drinking water levels of

comparison (DWLOCs) are calculated

and used as a point of comparison

against the model estimates of a

pesticide’s concentration in water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food, and from

residential uses. Since DWLOCs address

total aggregate exposure to clethodim

they are further discussed in the

aggregate risk sections below.

Based on the GENEEC and SCI-GROW

models the estimated environmental

concentrations (EECs) of clethodim for

chronic exposures are estimated to be

24.2 ppb for surface water and 0.49 ppb

for ground 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 use on

any sites that would result in residential

exposure. Based on clethodim labels,

Select and Select 2EC are both

available for weed control use in

residential and/or public areas.

However, the registrant has indicated

that the product is not for use by

homeowners. Therefore, homeowners

will not handle clethodim products, and

a non-occupational handler exposure

assessment is not necessary. Following

treatment by professional applicators,

the public could potentially come into

contact with clethodim residues in areas

such as patios, along driveways and

around golf courses and fence lines.

However, weed control with clethodim

in theses areas generally consists of a

spot treatment, resulting in a very small

treated area, and it is unlikely that

children would be exposed to these

treated areas. Therefore, a nonoccupational postapplication exposure

assessment was not performed.

4. Cumulative exposure to substances

with a common mechanism of toxicity.

Section 408(b)(2)(D)(v) 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 does not have, at this time,

available data to determine whether

clethodim has a common mechanism of

toxicity with other substances or how to

include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

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 final rule for Bifenthrin Pesticide

Tolerances (62 FR 62961, November 26,

1997).

D. Safety Factor for Infants and

Children

1. In general. FFDCA section 408

provides that EPA shall apply an

additional ten-fold margin of safety for

Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations 30331

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

that a different margin of safety will be

safe for infants and children. Margins of

safety are incorporated into EPA risk

assessments either directly through use

of a margin of exposure (MOE) analysis

or through using uncertainty (safety)

factors in calculating a dose level that

poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity.

The oral perinatal and prenatal data

demonstrated no indication of increased

sensitivity of rats or rabbits to in utero

exposure to clethodim.

3. Conclusion. There is a complete

toxicity database for clethodim and

exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures. EPA

determined that the 10X safety factor to

protect infants and children should be

removed. The FQPA factor is removed

primarily because there is no indication

of quantitative or qualitative increased

susceptibility of rats or rabbits to in

utero and/or postnatal exposure.

E. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

and residential uses, the Agency

calculates DWLOCs which are used as a

point of comparison against the model

estimates of a pesticide’s concentration

in water (EECs). DWLOC values are not

regulatory standards for drinking water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food and residential

uses. In calculating a DWLOC, the

Agency determines how much of the

acceptable exposure (i.e., the PAD) is

available for exposure through drinking

water e.g., allowable chronic water

exposure (mg/kg/day) = cPAD - (average

food + residential exposure). This

allowable exposure through drinking

water is used to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking water

consumption, and body weights. Default

body weights and consumption values

as used by the USEPA Office of Water

are used to calculate DWLOCs: 2L/70 kg

(adult male), 2L/60 kg (adult female),

and 1L/10 kg (child). Default body

weights and drinking water

consumption values vary on an

individual basis. This variation will be

taken into account in more refined

screening-level and quantitative

drinking water exposure assessments.

Different populations will have different

DWLOCs. Generally, a DWLOC is

calculated for each type of risk

assessment used: acute, short-term,

intermediate-term, chronic, and cancer.

When EECs for surface water and

groundwater are less than the calculated

DWLOCs, the Office of Pesticides

Programs (OPP) concludes with

reasonable certainty that exposures to

the pesticide in drinking water (when

considered along with other sources of

exposure for which OPP has reliable

data) would not result in unacceptable

levels of aggregate human health risk at

this time. Because OPP considers the

aggregate risk resulting from multiple

exposure pathways associated with a

pesticide’s uses, levels of comparison in

drinking water may vary as those uses

change. If new uses are added in the

future, OPP will reassess the potential

impacts of residues of the pesticide in

drinking water as a part of the aggregate

risk assessment process.

1. Acute risk. An endpoint for acute

dietary exposure was not identified

since no effects were observed in oral

toxicity studies that could be

attributable to a single dose.

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to clethodim from food

will utilize 29% of the cPAD for the

U.S. population, 43% of the cPAD for

infants less than one year old] and 60%

of the cPAD for children 1–6 years old.

There are no residential uses for

clethodim that result in chronic

residential exposure to clethodim. In

addition, there is potential for chronic

dietary exposure to clethodim in

drinking water. After calculating

DWLOCs and comparing them to the

EECs for surface and ground water, EPA

does not expect the aggregate exposure

to exceed 100% of the cPAD, as shown

in the following Table 3:

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO CLETHODIM

Population Subgroup cPAD

(mg/kg)

%

cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. Population (total) 0.01 29 24.2 0.49 250

All Infants (< 1 year) 0.01 43 24.2 0.49 57

Children 1–6 years 0.01 60 24.2 0.49 40

Children 7–12 years 0.01 42 24.2 0.49 58

Females 13–50 years 0.01 22 24.2 0.49 230

3. Short-term risk. Short-term and

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.

4. Aggregate cancer risk for U.S.

population. Clethodim has been

classified as a group E carcinogen.

Therefore, clethodim is not expected to

pose a cancer risk to humans.

5. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, and to infants and children

from aggregate exposure to clethodim

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The method RM-26B-3 (a

modification of RM-26B-2) was

validated for potatoes, processed potato

commodities, sugar beets, sunflowers,

bell peppers, non-bell peppers, celery,

cantaloupes, and clover. The limit of

quantitation (LOQ) was determined to

be 0.1 ppm for cantaloupes and bell

peppers, 0.2 ppm for potatoes, sugar

beets, sunflowers, celery and non-bell

30332 Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations

peppers, and 0.5 ppm for clover.

Average recoveries for all the

commodities were within the acceptable

range at all fortification levels tested.

The common moiety method RM-26B-3

for the determination of clethodim and

its metabolites in potatoes, processed

potato commodities, sugar beets,

sunflowers, bell peppers, non-bell

peppers, celery, cantaloupes, and clover

is acceptable for data collection and

enforcement purposes.

Method RM-26B-2 was validated for

the analyses of residues of clethodim in/

on radish, carrots, cucumbers,

cranberries, and strawberries. The limit

of quantitation (LOQ) was determined to

be 0.05 ppm for strawberries and

cranberries, 0.1 ppm for carrots, and

0.16 ppm for radish. Average recoveries

were within the acceptable range for all

fortification levels tested and all

commodities. The method RM-26B-2 for

the determination of clethodim and its

metabolites in radish, carrots

cucumbers, cranberries, and

strawberries is acceptable for data

collection and enforcement purposes.

The common moiety method RM-26B3 for the determination of clethodim

and its metabolites is similar to the

common moiety method RM-26B-2. The

method RM-26B-2 has previously

undergone a successful Independent

Laboratory Validation (ILV) and an

Agency Petition Method Validation.

Additionally, a confirmatory method,

EPA-RM-26D-2 is also available. Both

methods (RM-26B-2 and RM-26D-2)

have been forwarded to FDA as

enforcement methods for inclusion in

the Pesticide Analytical Manual,

Volume II (PAM II).

The method may be requested from:

Calvin Furlow, PIRIB, IRSD (7502C),

Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

305–5229; e-mail address:

furlow.calvin@epa.gov.

B. International Residue Limits

There are no established Codex

maximum residue limits (MRLs) for

residues of clethodim and its

metabolites in/on the commodities

discussed in the subject petition;

therefore, there are no questions with

respect to Codex/U.S. tolerance

compatibility.

V. Conclusion

Therefore, the tolerance is established

for combined residues of 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)cyclohexene-3-one and

5-(2-(ethylthiopropyl)-5-

hydroxycyclohexene-3-one moieties and

their sulphoxides and sulphones,

expressed as clethodim, in or on alfalfa

forage at 6 ppm, alfalfa hay at 10 ppm,

dry beans at 2 ppm, peanut hay at 3

ppm, peanut meal at 5 ppm, peanuts at

3 ppm, tomato paste at 3 ppm, and

tomato puree at 2 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–301134 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

on or before August 6, 2001.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(s) on which a hearing

is requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the objector (40

CFR 178.27). Information submitted in

connection with an objection or hearing

request may be claimed confidential by

marking any part or all of that

information as CBI. Information so

marked will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the

information that does not contain CBI

must be submitted for inclusion in the

public record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. The Office of

the Hearing Clerk is open from 8 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The telephone

number for the Office of the Hearing

Clerk is (202) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

Unit VI.A., you should also send a copy

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket control

number OPP–301134, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. In

person or by courier, bring a copy to the

location of the PIRIB described in Unit

Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations 30333

I.B.2. You may also send an electronic

copy of your request via e-mail to: oppdocket@epa.gov. Please use an ASCII

file format and avoid the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 6.1/8.0 or

ASCII file format. Do not include any

CBI in your electronic copy. You may

also submit an electronic copy of your

request at many Federal Depository

Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

VII. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d) 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). 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., or 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). Nor does it require any

special considerations as required by

Executive Order 12898, entitled Federal

Actions to Address Environmental

Justice in Minority Populations and

Low-Income Populations (59 FR 7629,

February 16, 1994); or OMB review or

any Agency action under Executive

Order 13045, entitled Protection of

Children from Environmental Health

Risks and Safety Risks (62 FR 19885,

April 23, 1997). 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).

Since tolerances and exemptions that

are established on the basis of a petition

under FFDCA section 408(d), 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. In addition, the

Agency has determined that this action

will not have a substantial direct effect

on States, on the relationship between

the national government and the States,

or on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

For these same reasons, the Agency has

determined that this rule does not have

any ‘‘tribal implications’’ as described

in Executive Order 13175, entitled

Consultation and Coordination with

Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

‘‘meaningful and timely input by tribal

officials in the development of

regulatory policies that have tribal

implications.’’ ‘‘Policies that have tribal

implications’’ is defined in the

Executive Order to include regulations

that have ‘‘substantial direct effects on

one or more Indian tribes, on the

relationship between the Federal

government and the Indian tribes, or on

the distribution of power and

responsibilities between the Federal

government and Indian tribes.’’ This

rule will not have substantial direct

effects on tribal governments, on the

relationship between the Federal

government and Indian tribes, or on the

distribution of power and

responsibilities between the Federal

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.’’

VIII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, 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 21, 2001.

James Jones,

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), 346(a) and

371.

2. Section 180.458 is amended by

revising the section heading and by

revising paragraph (a)(2) to read as

follows:

§180.458 Clethodim, tolerances for

residues.

(a) General.* * *

(2) Time limited tolerances are

established for the combined residues of

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)cyclohexene-3-one and

5-(2-(ethylthiopropyl)-5-

hydroxycyclohexene-3-one moieties and

their sulphoxides and sulphones,

expressed as clethodim in or on the

following raw agricultural commodities:

30334 Federal Register / Vol. 66, No. 109 / Wednesday, June 6, 2001 / Rules and Regulations

Commodity Parts per

million

Expiration/

Revocation

Date

Alfalfa, forage ......... 6 4/30/03

Alfalfa, hay .............. 10 4/30/03

Dry beans ............... 2 4/30/03

Peanuts ................... 3 4/30/03

Peanut, hay ............ 3 4/30/03

Peanut, meal .......... 5 4/30/03

Tomato, paste ......... 3 4/30/03

Tomato, puree ........ 2 4/30/03

* * * * *

[FR Doc. 01–14084 Filed 6–5–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

Tolerances and Exemptions from

Tolerances for Pesticide Chemicals in

Food

CFR Correction

In Title 40 of the Code of Federal

Regulations, parts 150 to 189, revised as

of July 1, 2000, part 180 is corrected by

adding § 180.200 to read as follows:

§ 180.200 Dicloran; tolerances for

residues.

(a) General. (1) Tolerances are

established for residues of the fungicide

2,6- dichloro-4-nitroaniline in or on the

following raw agricultural commodities.

Unless otherwise specified, these

tolerances prescribed in this paragraph

provide for residues from preharvest

application only.

Commodity Parts per

million

Apricot (PRE- and POST-H) ........ 20

Bean, snap ................................... 20

Carrot (POST-H) ........................... 10

Celery ........................................... 15

Cherry, sweet (PRE- and POSTH) .............................................. 20

Cucumber ..................................... 5

Endive (escarole) .......................... 10

Garlic ............................................ 5

Grape ............................................ 10

Lettuce .......................................... 10

Nectarine (PRE- and POST-H) .... 20

Onion ............................................ 10

Peach (PRE- and POST-H) ......... 20

Plum (fresh prune) (PRE- and

POST-H) ................................... 15

Potato ........................................... 0.25

Rhubarb ........................................ 10

Sweet potato (POST-H) ............... 10

Tomato .......................................... 5

(2) Unless otherwise specified, these

tolerances prescribed in this section

provide for residues from preharvest

application only.

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for combined residues of the fungicide,

dicloran, 2,6-dichloro-4-nitroaniline in

connection with use of the pesticide

under section 18 emergency exemptions

granted by EPA. The tolerances will

expire and are revoked on the dates

specified in the following table.

Commodity Parts per

million

Expiration/

Revocation

Date

Peanut, oil ............... 6.0 10/31/01

Peanuts ................... 3.0 10/31/01

(c) Tolerances with regional

registrations. Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[46 FR 27938, May 22, 1981, as amended at

63 FR 162, Jan. 5, 1998; 63 FR 57073, Oct.

26, 1998; 64 FR 13096, Mar. 17, 1999]

[FR Doc. 01–55507 Filed 6–5–01; 8:45 am]

BILLING CODE 1505–01–D

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 54

Universal Service

CFR Correction

In Title 47 of the Code of Federal

Regulations, Parts 40 to 69, revised as of

October 1, 2000, part 54 is corrected by

adding § 54.707 as set forth below:

§ 54.707 Audit controls.

The Administrator shall have

authority to audit contributors and

carriers reporting data to the

administrator. The Administrator shall

establish procedures to verify discounts,

offsets, and support amounts provided

by the universal service support

programs, and may suspend or delay

discounts, offsets, and support amounts

provided to a carrier if the carrier fails

to provide adequate verification of

discounts, offsets, or support amounts

provided upon reasonable request, or if

directed by the Commission to do so.

The Administrator shall not provide

reimbursements, offsets or support

amounts pursuant to part 36 and

§ 69.116 through 69.117 of this chapter,

and subparts D, E, and G of this part to

a carrier until the carrier has provided

to the Administrator a true and correct

copy of the decision of a state

commission designating that carrier as

an eligible telecommunications carrier

in accordance with § 54.201.

[FR Doc. 01–55517 Filed 6–5–01; 8:45 am]

BILLING CODE 1505–01–D

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 64

[CC Docket Nos. 00–257 and 94–129; FCC

01–156]

2000 Biennial Review—Review of

Policies and Rules Concerning

Unauthorized Changes of Consumers

Long Distance Carriers

AGENCY: Federal Communications

Commission.

ACTION: Final rule, correction.

SUMMARY: This document corrects an

error in the docket heading portion of a

Federal Register document regarding

streamlined waiver procedures that the

Commission adopted for the carrier-tocarrier sale or transfer of subscriber

basis. The Commission’s new

procedures provide for an acquiring

carrier to simply self-certify to the

Commission, in advance of the transfer,

that the carrier will follow the required

procedures. The summary was

published in the Federal Register on

May 22, 2001.

DATES: Effective June 6, 2001.

FOR FURTHER INFORMATION CONTACT:

Michele Walters, Associate Division

Chief, or Dana Walton-Bradford,

Attorney, Common Carrier Bureau,

Accounting Policy Division, (202) 418–

7400.

SUPPLEMENTARY INFORMATION: This

summary contains a correction to the

heading portion of a Federal Register

summary, 66 FR 28117 (May 22, 2001).

The full text of the Commission’s Report

and Order is available for public

inspection during regular business

hours in the FCC Reference Center,

Room CY–A257, 445 Twelfth Street,

SW., Washington, DC 20554.

Correction

1. On page 28117, in the second

column, in the docket heading, ‘‘FCC

01–153’’ is corrected to read ‘‘FCC 01–

156.’’

Federal Communications Commission.

Magalie Roman Salas,

Secretary.

[FR Doc. 01–14168 Filed 6–5–01; 8:45 am]

BILLING CODE 6712–01–P