Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations 30073

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 17, 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 180.510 is amended by

revising the introductory text in

paragraph (a)(1) and alphabetically

adding the commodity ‘‘pistachio’’ to

the table to read as follows:

§ 180.510 Pyriproxyfen; tolerances for

residues.

(a) General. (1) Tolerances are

established for residues of the

insecticide pyriproxyfen 2-[1-methyl-2-

(4-phenoxyphenoxy)ethoxypyridine in

or on the following food commodities:

Commodity Parts per million

*****

Pistachio ...................................................................................................................................... 0.02

** ***

* * * * *

[FR Doc. 01–14085 Filed 6–4–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301133; FRL–6783–5]

RIN 2070–AB78

Clethodim; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for combined residues of

clethodim in or on the root vegetable

(except sugar beet) subgroup. The

Interregional Research Project Number 4

(IR-4) requested this tolerance under the

Federal Food, Drug, and Cosmetic Act

(FFDCA), as amended by the Food

Quality Protection Act (FQPA) of 1996.

This final rule establishes permanent

tolerances for clethodim and as part of

that process the Agency has reassessed

existing tolerances. By law, EPA is

required to reassess 66% of the

tolerances in existence on August 2,

1996, by August 2002, or about 6,400

tolerances. All permanent tolerances for

clethodim that existed on August 2,

1996, were previously reassessed by

April 1998. Consequently, regarding the

actions in this final rule, no tolerance

reassessments are counted toward the

August 2002 review deadline of FFDCA

section 408(q).

DATES: This regulation is effective June

5, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301133, 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–301133 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Shaja R. Brothers, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–3194; and e-mail

address: brothers.shaja@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

codes

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://

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

theFederal Register listings at http://

www.epa.gov/fedrgstr/. A frequently

updated electronic version of 40 CFR

part 180 is available at http://

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

cfrhtml_00/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–301133. 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.

30074 Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations

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 29,

2000 (65 FR 16602) (FRL–6495–5), EPA

issued 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

petition (PP 0E6097) for tolerances by

IR-4, Rutgers, the State University of

New Jersey, 681 U.S. Highway No. 1

South, North New Brunswick, NJ 08902

and Valent USA Corporation, Walnut

Creek, CA 94596–8025. This notice

included a summary of the petition

prepared by Valent USA Corporation,

the registrant.

The petition requested that 40 CFR

180.458 be amended by establishing

tolerances for combined residues of the

herbicide clethodim, [(E)-(±)-2-[1-[[(3-

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

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

cyclohexen-1-one] and its metabolites

containing the 5-(2-

(ethylthiopropyl)cyclohexene-3-one and

5-(2-(ethylthiopropyl)-5-

hydroxycyclohexene-3-one moieties and

their sulphoxides and sulphones, on

various commodities with the following

tolerance levels at parts per million

(ppm): root vegetables subgroup at 1.0

ppm, leaves of root and tuber vegetables

group at 2.0 ppm, leafy petiole

vegetables subgroup at 0.5 ppm, melon

subgroup at 2.0 ppm, squash/cucumber

subgroup at 0.5 ppm, cranberry at 0.5

ppm, clover forage at 10 ppm, clover

hay at 20.0 ppm, and strawberry at 5.0

ppm. In response to IR-4’s petition, EPA

issued a final rule in the Federal

Register of March 14, 2001 (66 FR

14829) (FRL–6770–8) establishing

tolerances for combined residues of

clethodim and its metabolites in or on

carrots at 0.50 ppm, radish roots at 0.50

ppm, radish tops at 0.70 ppm, leaf

petioles subgroup at 0.60 ppm, melon

subgroup at 2.0 ppm, squash/cucumber

subgroup at 0.50 ppm, cranberry at 0.5

ppm, strawberry at 3.0 ppm, clover

forage at 10.0 ppm, and clover hay at

20.0 ppm. Tolerances were established

for carrot and radish roots, which are

members of the root vegetable (except

sugar beet) subgroup, in the final rule of

March 14, 2001, but not the subgroup

since EPA had not completed its

evaluation of the residue data submitted

in support of the subgroup tolerance.

EPA has now completed the review of

the residue data and has concluded that

the data support a tolerance for

combined residues of clethodim and its

metabolites in or on the root vegetable

(except sugar beet) subgroup at 1.0 ppm.

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 the

root vegetable (except sugar beet)

subgroup at 1.0 ppm. EPA’s assessment

of exposures and risks associated with

establishing this 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 Unit III.A. of the Federal

Register of March 14, 2001.

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

intraspecies 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

Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations 30075

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 (MOE cancer =

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 1:

TABLE 1.—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 Levelof

Concern (LOC) for Risk AssessmentStudy and Toxicological Effects

Acute dietary all populations N/A N/A None selected.

There were no effects observed in oral toxicity

studies including developmental toxicity studies in rats and rabbits that could be attributable to a single dose (exposure). Therefore, a dose and endpoint were not selected

for this risk assessment.

Chronic dietary all populations NOAEL= 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)

(residental)

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).

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

residues of clethodim in or on a variety

of food commodities: including the

representative commodities of the root

vegetable (except sugar beet) subgroup

(carrots and radish roots at 0.5 ppm) and

the related tuberous and corm vegetable

subgroup 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 1 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.

30076 Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations

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 milligram/kilogram/day (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

percent crop treated (PCT) 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 was

not performed.

iv. Anticipated residue and PCT

information. 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 PCT as required by

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

registrants to submit data on PCT.

The Agency used PCT information as

follows:

Cotton 3%, onions 8%, peanuts 3%,

soybeans 4%, sugar beets 15%, and

tomatoes 1%.

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

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.

Clethodim does not show a significant

potential for bio-accumulation in

aquatic organisms. Although they have

not been individually tested, the

primary degradates are highly polar, and

would not be expected to bioaccumulate.

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

Screening Concentrations in Ground

Water (SCI-GROW), which predicts

pesticide concentrations in ground

water. In general, EPA will use GENEEC

(a tier 1 model) before using PRZM/

EXAMS (a tier 2 model) for a screeninglevel 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

Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations 30077

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 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 non-occupational

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. Safety factor for infants and

children—i. In general. FFDCA section

408 provides that EPA shall apply an

additional 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 base 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.

ii. 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.

2. Conclusion. There is a complete

toxicity data base for clethodim and

exposure data are complete or are

estimated based on data that reasonably

account for potential exposures. Based

on the above, EPA determined that the

1X safety factor to protect infants and

children should be removed.

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

ground water are less than the

calculated DWLOCs, EPA concludes

with reasonable certainty that exposures

to the pesticide in drinking water (when

considered along with other sources of

exposure for which EPA has reliable

data) would not result in unacceptable

levels of aggregate human health risk at

this time. Because EPA 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, EPA 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

all infants (< 1 year) 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 2.

30078 Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations

TABLE 2.—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 and intermediate-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

Method RM-26B-2 was validated by

IR-4 for the analyses of residues of

clethodim in/on radish and carrots. The

limit of quantitation (LOQ) was

determined to be 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 RM26B-2 for the determination of

clethodim and its metabolites in radish

and carrots is acceptable for data

collection and meets the requirements

for a residue analytical method to

enforce tolerances.

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 and RM-26D-2 have

completed an Independent Laboratory

Validation (ILV) and also have

completed Tolerance Methods

Validations (TMVs) in the Agency’s

laboratory. Additionally, the compound

specific method, EPA-RM-26D-2 is also

available and is suitable for residue data

collection and as a residue analytical

methold to enforce tolerances. Both

methods have been forwarded to FDA

for inclusion in a future edition of the

Pesticide Analytical Manual, Volume II

(PAM II).

The methods may be requested from:

Francis Griffith, Analytical Chemistry

Branch, Environmental Science Center,

701 Mapes Road, Fort George G. Mead,

Maryland, 20755–5350; telephone

number: (410) 305–2905; e-mail address:

griffith.francis@epa.gov.

B. International Residue Limits

There are no established Codex

maximum residue limits (MRLs) for

residues of clethodim and its

metabolites in/on commodity members

of the root vegetable (except sugar beet

subgroup); therefore, there are no

questions with respect to Codex/U.S.

tolerance compatibility.

V. Conclusion

Therefore, this 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, in or

on the root vegetable (except sugar beet)

subgroup at 1.0 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–301133 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

Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations 30079

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–301133, 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

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 require 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

30080 Federal Register / Vol. 66, No. 108 / Tuesday, June 5, 2001 / Rules and Regulations

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 23, 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

alphabetically adding the entry

vegetable, root (except sugar beet)

subgroup to the table in paragraph

(a)(3), by revising the entry for

vegetable, tuberous and corm group, and

by deleting the entries for carrot and

radish roots to read as follows:

§ 180.458 [((E)-(±)-2-[1-[[(3-chloro-2-

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

(ethylthio)propyl]-3-hydroxy-2-cyclohexen1-one); tolerances for residues.

(a) * * *

(3) * * *

Commodity Parts per million

*****

Vegetable, root (except sugar beet) subgroup ........................................................ 1.0

*****

Vegetable, tuberous and corm, subgroup ............................................................... 1.0

* * * * *

[FR Doc. 01–14086 Filed 6–4–01; 8:45 am]

BILLING CODE 6560–50–S

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Parts 36 and 54

[CC Docket Nos. 96–45 and 00–256; FCC

01–157]

Federal-State Joint Board on Universal

Service; Multi-Association Group

(MAG) Plan for Regulation of Interstate

Services of Non-Price Cap Incumbent

Local Exchange Carriers and

Interexchange Carriers

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: In this document, the

Commission takes actions in response to

the Rural Task Force’s recommended

reforms to rural high-cost universal

service support and the proposals made

by the Multi-Association Group (MAG)

relating to this universal service support

mechanism.

DATES: Effective June 5, 2001, except for

§§ 36.605(c)(2), 36.611, 54.305(f), the

amendments to § 54.307(b), §§ 54.313(b)

and (c), 54.314, and 54.315, which

contain information collection

requirements that have not been

approved by the Office of Management

Budget (OMB). The Commission will

publish a document in the Federal

Register announcing the effective date

of those sections.

FOR FURTHER INFORMATION CONTACT:

Genaro Fullano, Paul Garnett, or Greg

Guice, Attorney, Common Carrier

Bureau, Accounting Policy Division,

(202) 418–7400.

SUPPLEMENTARY INFORMATION: This is a

summary of the Commission’s

Fourteenth Report and Order, TwentySecond Order on Reconsideration in CC

Docket No. 96–45 and Report and Order

in CC Docket No. 00–256 released on

May 23, 2001. The full text of this

document is available for public

inspection during regular business

hours in the FCC Reference Center,

Room CY–A257, 445 Twelfth Street,

SW., Washington, DC, 20554.

I. Executive Summary

1. In this Order, we take the following

actions in response to the Rural Task

Force’s recommended reforms to rural

high-cost universal service support and

the proposals made by the MultiAssociation Group (MAG) relating to

this mechanism:

• We adopt the Rural Task Force’s

recommendation to re-base the high-cost

loop support fund for rural telephone

companies and retain an indexed cap on

the fund. We conclude that re-basing the

indexed fund will ensure that rural

carriers are able to are able tocontinue

providing supported services at

affordable and reasonably comparable

rates during the transition to a more

permanent high-cost support

mechanism for rural carriers.

• We adopt a ‘‘rural growth factor’’

that allows the high-cost loop support

fund to grow based on annual changes

in the Gross Domestic Product-Chained

Price Index (GDP–CPI) and the total

number of working loops of rural

carriers. We find that allowing the fund

to grow in this fashion over the next five

years will enable rural carriers to make

prudent investments in rural America.

• We adopt the Rural Task Force’s

recommendation to freeze the national

average loop cost at $240.00. We

conclude that freezing the national

average loop cost will provide rural

carriers with greater certainty as to their

eligibility for high-cost loop support.

• We adopt a modified version of the

Rural Task Force’s proposal as it relates

to corporate operations expenses. We

revise the corporate operations expense

limitation calculation so that the dollar

values in the formula are re-based and

indexed by the GDP–CPI.

• We also raise the minimum cap in

the revised corporate operations

expense limitation formula.

Specifically, we permit small rural

carriers to receive support for corporate

operations expenses of up to $600,000

or amounts derived from the revised

corporate operations expense formula,

whichever is greater. We find that

raising the minimum cap from $300,000

to $600,000 will enable small rural

carriers to receive more support for

corporate operations expenses without

having to file for waiver of our rules.

• We adopt a modified version of the

Rural Task Force’s proposed ‘‘safety net

additive’’ so that a carrier will receive