10196 Federal Register / Vol. 66, No. 31 / Wednesday, February 14, 2001 / Rules and Regulations

(viii) Hardware and software

requirements. The recipient must be

provided with a description of the

hardware and software required to

access, print, and retain the Form W–2,

and the date when the Form W–2 will

no longer be available on the website.

The recipient must be informed that the

Form W–2 may be required to be

printed and attached to a Federal, State,

or local income tax return.

(4) Format. The electronic version of

the Form W–2 must contain all required

information and comply with applicable

revenue procedures relating to

substitute statements to recipients.

(5) Posting. The furnisher must on or

before January 31 of the year following

the calendar year to which the Form W–

2 relates (or such other date permitted

or required for furnishing the Forms W–

2) post it on a website accessible to the

recipient.

(6) Notice—(i) In general. The

furnisher must on or before January 31

of the year following the calendar year

to which the Form W–2 relates (or such

other date permitted or required for

furnishing the Form W–2) notify the

recipient that the Form W–2 is posted

on a website. The notice may be

delivered by mail, electronic mail, or in

person. The notice must provide

instructions on how to access and print

the statement. The notice must include

the following statement in capital

letters, ‘‘IMPORTANT TAX RETURN

DOCUMENT AVAILABLE.’’ If the

notice is provided by electronic mail,

the foregoing statement should be on the

subject line of the electronic mail and

sent with high importance.

(ii) Undeliverable electronic address.

If an electronic notice described in

paragraph (j)(6)(i) of this section is

returned as undeliverable, and the

correct electronic address cannot be

obtained from the furnisher’s records or

from the recipient, then the furnisher

must furnish the notice by mail or in

person within 30 days after the

electronic notice is returned.

(iii) Corrected Forms W–2. A furnisher

must notify a recipient that it has posted

corrected Forms W–2 on a website

within 30 days of such posting in the

manner described in paragraph (j)(6)(i)

of this section. This notice must be

furnished by mail or in person if—

(A) An electronic notice of the

website posting of an original Form W–

2 was returned as undeliverable; and

(B) The recipient has not provided a

new e-mail address.

(7) Retention. The furnisher must

maintain access to the Forms W–2 on

the website through October 15 of the

year following the calendar year to

which the Forms W–2 relate (or the first

business day after October 15, if October

15 falls on a Saturday, Sunday, or legal

holiday). The furnisher must maintain

access to corrected Forms W–2 that are

posted on the website through October

15 of the year following the calendar

year to which the Forms W–2 relate (or

the first business day after such October

15, if October 15 falls on a Saturday,

Sunday, or legal holiday) or the date 90

days after the corrected forms are

posted, whichever is later.

(k) Effective date. Paragraph (j) of this

section applies to Forms W–2 required

to be furnished under section 6051 after

December 31, 2000.

PART 301—PROCEDURE AND

ADMINISTRATION

Par. 6. The authority citation for part

301 continues to read in part as follows:

Authority: 26 U.S.C. 7805 * * *

Par. 7. Section 301.6724–1T is added

to read as follows:

§ 301.6724–1T Reasonable cause

(temporary).

(a) through (d)(2) [Reserved]. For

further information, see § 301.6724–1 (a)

through (d)(2).

(d)(3) Special rule for furnishers of

electronic statements. A filer may seek

a waiver for reasonable cause pursuant

to § 301.6724–1(c)(6), for failing to

timely furnish a statement in the

following situation. If the recipient of

the statement withdraws a consent to

receive the statement in an electronic

format, the filer will be deemed to have

acted in a responsible manner under

§ 301.6724–1(d) if the filer furnishes a

paper statement on or before the date 30

days after the date the withdrawal of

consent is received.

(e) through (n) [Reserved]. For further

guidance, see § 301.6724–1(e) through

(n).

PART 602—OMB CONTROL NUMBERS

UNDER THE PAPERWORK

REDUCTION ACT

Par. 8. The authority citation for part

602 continues to read as follows:

Authority: 26 U.S.C. 7805.

Par. 9. In § 602.101, paragraph (b) is

amended by adding entries to the table

in numerical order to read as follows:

§ 602.101 OMB Control numbers.

* * * * *

(b) * * *

CFR part or section where

identified and described

Current OMB

control No.

*****

1.6041–2T ............................. 1545–1729

*****

1.6050S–1T .......................... 1545–1729

1.6050S–2T .......................... 1545–1729

*****

31.6051–1T ........................... 1545–1729

*****

Robert E. Wenzel,

Deputy Commissioner of Internal Revenue.

Approved: January 10, 2001.

Jonathan Talisman,

Assistant Secretary of the Treasury.

[FR Doc. 01–1292 Filed 2–13–01; 8:45 am]

BILLING CODE 4830–01–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301101; FRL–6764–2]

RIN 2070–AB78]

Clomazone; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of clomazone in

or on tuberous and corm vegetable

(except potato) subgroup crop and

cucurbit vegetable crop group.

Interregional Research Project Number 4

(IR—4) requested these tolerances under

the Federal Food, Drug, and Cosmetic

Act, as amended by the Food Quality

Protection Act of 1996.

DATES: This regulation is effective

February 14, 2001. Objections and

requests for hearings, identified by

docket control number OPP–301101,

must be received by EPA on or before

April 16, 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–301101 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

Federal Register / Vol. 66, No. 31 / Wednesday, February 14, 2001 / Rules and Regulations 10197

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

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.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301101. 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 December 6,

2000 (65 FR 76249) (FRL–6755–4), 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 9E6063 and 7E4865) for

tolerance by IR–4, 681 U.S. Highway #1

South, North Brunswick, New Jersey

08902–3390. This notice included a

summary of the petitions prepared by

FMC Corporation, the registrant. There

were no comments received in response

to the notice of filing.

The petition requested that 40 CFR

180.425 be amended by establishing

tolerances for residues of the herbicide

clomazone, [2-(2-chlorophenyl)methyl4,4-dimethyl-3-isoxazolidinone], in or

on tanier, cassava, yams, arracacha, and

cucurbit vegetables at 0.05 and 0.1 parts

per million (ppm). The petition was

subsequently amended to tuberous and

corm vegetable (except potato) crop

subgroup and cucurbit vegetable crop

group at 0.05 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

residues of clomazone on the tuberous

and corm vegetable (except potato) crop

subgroup and cucurbit vegetable crop

group at 0.05 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 clomazone 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.

10198 Federal Register / Vol. 66, No. 31 / Wednesday, February 14, 2001 / Rules and Regulations

TABLE 1. — SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results

870.3100 90-Day oral toxicity rat NOAEL = 135.2/160.9 mg/kg/day, males/females LOAEL = 273/

319.3 mg/kg/day, males/females, based on decreased body

weight, body weight gains, food consumption and increased absolute and relative liver weights in females and increased absolute liver weights in males

870.3100 90-Day oral toxicity mouse NOAEL ≥ 1,200 mg/kg/day (limit dose) LOAEL > 1,200 mg/kg/day

870.3700a Prenatal developmental rat Maternal NOAEL = 100 mg/kg/day LOAEL = 300 mg/kg/day based

on chromorhinorrhea and/or abdominogenital staining Developmental NOAEL = 100 mg/kg/day LOAEL = 300 mg/kg/day based

on indications of delayed ossification in the form of either partial

ossification or the absence of manubrium, sternebrae 3–4, xiphoid, caudal, and metacarpals

870.3700b Prenatal developmental rabbits Maternal NOAEL = 240 mg/kg/day LOAEL = 700 mg/kg/day based

on effects seen at 1,000 mg/kg/day, which included mortality,

abortions, decreased body weight gain, and decreased defecation or no feces Developmental NOAEL ≥ 700 mg/kg/day highest

dose tested (HDT) LOAEL > 700 mg/kg/day

870.3800 2–Generation reproduction and fertility effects Parental NOAEL = 50 mg/kg/day LOAEL = 100 mg/kg/day based

on statistically significantly decreased body weight and body

weight gain during pre-mating, and decreased body weight during

gestation & lactation male & female. In addition decreased food

consumption in females and hydro-nephritic kidneys in males.

Offspring NOAEL = 50 mg/kg/day LOAEL = 100 mg/kg/day

based on decreased body weight in F2a and F2b litters

870.4100b Chronic toxicity dogs NOAEL ≥ 1,038/1,012 mg/kg/day, males/females (HDT) LOAEL >

1,038/1,012 mg/kg/day

870.4300 Chronic toxicity/ Carcinogenicity rats NOAEL = 84.4/112.9 mg/kg/day, males/females (HDT) LOAEL ≥

84.4/112.9 mg/kg/day, males/females Classified as a ‘‘not likely

human carcinogen’’

870.4300 Carcinogenicity mice NOAEL = 300 mg/kg/day (HDT) LOAEL = > 300 mg/kg/day Classified as a ‘‘not likely human carcinogen’’

870.5100 Gene mutation Salmonella typhimurium and Escherichia coli reverse gene mutation assay)The test article was assayed up to cytotoxic concentrations (5,000

μg/plate), but in no instance were appreciably increased number

of revertants to histidine prototrophy (his+) found in any of the

tester strains, either in the presence or absence of metabolic activation.

870.5395 Cytogenetics In vivo rat Negative. The incidence of aberrations and the aberrations/cell

were not significantly increased.

870.5550 Other effects In vitro UDS assay in primary rat

hepatocytes

Clomazone was tested up to cytotoxicity (relative toxicity at 0.10

μL/mL was 88.6%), but in no cultures treated with test article was

a significant increase in mean net nuclear counts indicative of

UDS recorded.

870.7485 Metabolism and pharmacokinetics Clomazone is extensively metabolized by the liver and excreted in

the urine and feces within 24 hours. Sixteen metabolites, including the parent, were identified; and the predominant route of excretion was in urine.

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

Federal Register / Vol. 66, No. 31 / Wednesday, February 14, 2001 / Rules and Regulations 10199

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

(Q1*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q1* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q1* 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 (MOE cancer =

point of departure/exposures) is

calculated. A summary of the

toxicological endpoints for clomazone

used for human risk assessment is

shown in the following Table 2:

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

Exposure Scenario Dose Used in Risk Assessment,

UF

FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects

Acute Dietary females 13–50 years of

age

NOAEL = 100 mg/kg/day FQPA SF = 1X Developmental rat

UF = 100 aPAD = acute RfD ÷FQPA SF =

1.0 mg/kg/day

LOAEL = 300 mg/kg/day based

on delayed ossification.

Acute RfD = 1.0 mg/kg/day

Acute Dietary general population including infants and childrenNone None A risk assessment is not required for this population subgroup.

Chronic Dietary all populations NOAEL= 84.4 mg/kg/day FQPA SF = 1X 2—year rat feeding study

UF = 100 cPAD = chronic RfD ÷ FQPA

SF = 0.84 mg/kg/day

LOAEL > 84.4 mg/kg/day (HDT)

Chronic RfD = 0.84 mg/kg/day 90—day oral rat

LOAEL = 319.3 mg/kg/day

based on based on decreased body weight, body

weight gains, food consumption and increased absolute

and relative liver weights in

females and increased absolute liver weights in males.

2—Generation Reproduction

LOAEL = 100 mg/kg/day based

on statistically significantly

decreased body weight &

body weight gain during premating, and decreased body

weight during gestation & lactation male & female. In addition decreased food consumption in females and

hydro-nephritic kidneys in

males.

Oral, Short-Term (1 to 7 days) (Residential)None None No residential uses. An endpoint was not selected.

Oral, Intermediate-Term (1 week to several months) (Residential)None None No residential uses. An endpoint was not selected.

Dermal and Inhalation Short-Term (1 to

7 days) (Residential)

Maternal LOC for MOE = 100 Developmental rat study

NOAEL= 100 mg/kg/day Maternal

Dermal absorption = 100% LOAEL = 300 mg/kg/day, based

on chromorhinorrhea and

abdominogenital staining

Inhalation absorption = 100%

Dermal and Inhalation, Intermediate-term

(1 week - several months) and LongTerm (several months - lifetime) (Residential)

Oral LOC for MOE = 100 2–year rat feeding study

NOAEL= 84.4 mg/kg/day LOAEL > 84.4 mg/kg/day (HDT)

90–day oral rat

10200 Federal Register / Vol. 66, No. 31 / Wednesday, February 14, 2001 / Rules and Regulations

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

Continued

Exposure Scenario Dose Used in Risk Assessment,

UF

FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects

LOAEL = 319.3 mg/kg/day

based on based on decreased body weight, body

weight gains, food consumption and increased absolute

and relative liver weights in

females and increased absolute liver weights in males

2–Generation Reproduction

LOAEL = 100 mg/kg/day based

on statistically significantly

decreased body weight and

body weight gain during premating, and decreased body

weight during gestation & lactation male & female. In addition decreased food consumption in females and

hydro-nephritic kidneys in

males.

Dermal Absorption = 100%

Inhalation absorption = 100%

* 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 180.425) for the

residues of clomazone, in or on a variety

of raw agricultural commodities. Risk

assessments were conducted by EPA to

assess dietary exposures from

clomazone 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. 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 acute

exposure assessments: A Tier 1 acute

analysis was performed for females 13–

50 years old using existing and

recommended tolerance level residues,

100% crop treated.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

DEEM analysis evaluated the individual

food consumption as reported by

respondents in the USDA (1989–1992)

nationwide CSFII and accumulated

exposure to the chemical for each

commodity. The following assumptions

were made for the chronic exposure

assessments: A Tier 1 chronic analysis

was performed for the general U.S.

population and all population

subgroups using existing and

recommended tolerance level residues,

100% crop treated.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

clomazone 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

clomazone. Clomazone’s major

environmental degradate, FMC 65317

(N-[2- chlorophenol)methyl] -3-hydroxy2,2-dimethyl propanamide) was also

included in the drinking water

assessment.

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 concentration 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 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

Federal Register / Vol. 66, No. 31 / Wednesday, February 14, 2001 / Rules and Regulations 10201

total aggregate exposure to clomazone

they are further discussed in the

aggregate risk sections below.

Based on the GENEEC and SCI-GROW

models the EECs of clomazone and FMC

65317 for acute exposures are estimated

to be 95 parts per billion (ppb) for

surface water and 2.4 ppb for ground

water. The EECs for chronic exposures

are estimated to be 23 ppb for surface

water and 2.4 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, flea

and tick control on pets).

Clomazone is not registered for use on

any sites that would result in residential

exposure.

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

clomazone 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,

clomazone 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 clomazone 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 prenatal and postnatal toxicology

data base for clomazone is complete

with respect to FQPA considerations.

There is no quantitative or qualitative

evidence of increased susceptibility of

rats or rabbit fetuses to in utero

exposure in developmental studies.

Although there was a suggestion of

susceptibility in the rat developmental

study based on the presence of delayed

ossification in the fetuses, the EPA

concluded that the fetal effects were no

more severe than the maternal effects

because: There is no dose response

relationship for delayed ossification

(i.e., absence of increased incidence

with increase in dose); low fetal/litter

incidences; delayed ossifications were

not considered to be severe; and no

visceral or skeletal malformations were

seen.

iii. Conclusion. There is a complete

toxicity data base for clomazone and

exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures. The

FQPA factor was reduced to 1X because

of the following reasons: There is no

indication of quantitative or qualitative

increased susceptibility of rats or rabbits

to in utero and/or postnatal exposure; a

developmental neurotoxicity study is

not required; and the dietary (food and

drinking water) exposure assessments

will not under estimate the potential

exposures for infants and children

(there are currently no registered

residential uses).

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 US EPA Office of Water

are used to calculate DWLOCs: 2Liters

(L)/70kilograms (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, 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. A Tier 1 acute dietary

exposure analysis for clomazone was

performed using existing and proposed

tolerance level residues, 100 CT for all

commodities, and DEEM default

processing factors. The acute analysis

was performed for females 13–50 years

old. Using the exposure assumptions

discussed in this unit for acute

exposure, the acute dietary exposure

from food to clomazone will occupy

<1% of aPAD for females 13–50 years

and older at the 95th percentile. In

addition, there is potential for acute

dietary exposure to clomazone 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 aPAD, as shown

in the following Table 3:

10202 Federal Register / Vol. 66, No. 31 / Wednesday, February 14, 2001 / Rules and Regulations

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO CLOMAZONE

Scenario/Population Subgroup aPAD, mg/kg/

day % aPAD (Food) Surface Water,ppb

Ground

Water, ppb

DWLOC

ppb

Females 13–50 yrs old 1 1% 95 2.4 30,000

2. Chronic risk. A Tier 1 chronic

dietary exposure analysis for clomazone

was performed using existing and

proposed tolerance level residues, 100%

CT for all commodities, and DEEM

default processing factors. The chronic

analysis applied to the U.S. population

and all population subgroups. Using the

exposure assumptions described in this

unit for chronic exposure, EPA has

concluded that exposure to clomazone

from food will utilize <1% of the cPAD

for the U.S. population and all

population subgroups. There are no

residential uses for clomazone that

result in chronic residential exposure to

clomazone. 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 4:

TABLE 4. — AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO CLOMAZONE

Scenario/Population Subgroup cPAD, mg/kg/

day % cPAD (Food) Surface Water,ppb

Ground

Water, ppb

DWLOC,

ppb

U.S. Population 0.84 <1 23 2.4 29,000

All infants (< 1 year old) 0.84 <1 23 2.4 8,400

Children (1–6 years old) 0.84 <1 23 2.4 8,400

Children (7–12 years old) 0.84 <1 23 2.4 8,400

Females (13–50 years old) 0.84 <1 23 2.4 25,000

3. Short- and intermediate- term risk.

Short-and intermediate-term aggregate

exposure takes into account residential

exposure plus chronic exposure to food

and water (considered to be a

background exposure level).

Clomazone 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. 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 clomazone

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methods are

available for the determination of the

residues of clomazone in plants. Briefly,

samples are acid hydrolyzed, hexane

extracted, Na2CO3 washed, and cleanedup with a FlorisilR column. The

resulting samples are analyzed by gas

chromatography (GC) using a nitrogen

phosphorus detector (NPD) or mass

spectrometer (MS). The limit of

quantitation (LOQ) for this method is

0.05 ppm. A confirmatory procedure

(GC/MS-SIM) is available (Method I,

PAM II).

B. International Residue Limits

There is neither a Codex proposal, nor

Canadian or Mexican limits for residues

of clomazone in/on the subject crops.

Therefore, a compatibility issue is not

relevant to the proposed tolerance.

V. Conclusion

Therefore, tolerances are established

for residues of clomazone, [2-(2-

chlorophenyl)methyl-4,4-dimethyl-3-

isoxazolidinone], in or on the tuberous

and corm vegetable (except potato) crop

subgroup and cucurbit vegetable crop

group at 0.05 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–301101 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 April 16, 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

Federal Register / Vol. 66, No. 31 / Wednesday, February 14, 2001 / Rules and Regulations 10203

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–301101, 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

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); 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).

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

10204 Federal Register / Vol. 66, No. 31 / Wednesday, February 14, 2001 / Rules and Regulations

and pests, Reporting and recordkeeping

requirements.

Dated: January 18, 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 180.425 is amended by

alphabetically adding commodities to

the table in paragraph (a) to read as

follows:

§ 180.425 Clomazone; tolerances for

residues.

(a) General.* * *

Commodity Parts per

million

*****

Vegetable, cucurbit, group ....... 0.05

Vegetable, tuberous and corm,

except potato, subgroup ....... 0.05

* * * * *

[FR Doc. 01–3619 Filed 2–13–01; 8:45 am]

BILLING CODE 6560–50–S

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 73

[WT Docket No. 99–168; CS Docket No. 98–

120; MM Docket No. 00–39; FCC 01–25]

Clearing of the 740–806 MHz Band;

Conversion to Digital Television

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: In this document, the

Commission adopts mechanisms and

makes determinations intended to

facilitate the clearing of the 740–806

MHz band to allow for the introduction

of new wireless services, and to promote

the early transition of analog television

licensees to digital television service

(‘‘DTV’’). The Commission adopts rules

and policies that allow the private

sector to determine the band-clearing

mechanisms that will best suit

broadcasters’ and potential new 700

MHz licensees’ needs. By this action,

the Commission also builds upon the

policies adopted in the Memorandum

Opinion and Order and Further Notice

of Proposed Rule Making in this

proceeding (‘‘700 MHz MO&O and

FNPRM’’) in which it provided guidance

regarding its review of regulatory

requests filed in connection with

voluntary private agreements that would

accelerate the DTV transition and open

the 700 MHz band for new uses.

DATES: Effective February 14, 2001.

FOR FURTHER INFORMATION CONTACT:

Nese Guendelsberger or Bill Huber of

the Auctions and Industry Analysis

Division at (202) 418–0660 (voice), (202)

418–7233 (TTY), or Martin Liebman or

Stanley Wiggins of the Policy Division

at (202) 418–1310 (voice), (202) 418–

7233 (TTY), Wireless

Telecommunications Bureau.

SUPPLEMENTARY INFORMATION: This is a

summary of a Third Report and Order

(‘‘Third R&O’’) in WT Docket No. 99–

168, adopted on January 18, 2001, and

released on January 23, 2001. The

complete text of the Third R&O is

available for inspection and copying

during normal business hours in the

FCC Reference Center (Room CY–A257),

445 12th Street, SW, Washington, DC. It

may also be purchased from the

Commission’s copy contractor,

International Transcription Services,

Inc. (ITS, Inc.), 445 12th Street, SW,

Room CY–B400, Washington, DC 20554,

(202) 314–3070. The Third R&O is also

available on the Internet at the

Commission’s web site: http://

www.fcc.gov/Bureaus/Wireless/Orders/

2001/fcc01025. Alternative formats

(computer diskette, large print, audio

cassette and Braille) are available to

persons with disabilities by contacting

Martha Contee at (202) 418–0260, TTY

(202) 418–2555, or at mcontee@fcc.gov.

Synopsis of the Third Report and Order

1. By this Third R&O, the Commission

adopts mechanisms and makes

determinations intended to facilitate the

clearing of the 740–806 MHz band to

allow for the introduction of new

wireless services, and to promote the

early transition of analog television

licensees to DTV. The 746–806 MHz

band at issue has historically been used

exclusively by television stations

(Channels 60–69). The incumbent

television broadcasters are permitted by

statute to continue operations until their

markets are converted to digital

television, which is not scheduled to

occur until December 31, 2006, and that

date may be extended under certain

circumstances. Congress has, however,

mandated that the Commission

commence competitive bidding for the

commercial licenses well before the

scheduled termination date of the DTV

transition. In the 700 MHz MO&O and

FNPRM, (65 FR 42879 and 65 FR 42960,

July 12, 2000), the Commission

provided guidance on its review of

applications for approval of regulatory

requests associated with voluntary

agreements accelerating the transition of

incumbent analog television licensees

and opening these bands for new 700

MHz licensee use. The Third R&O

announces additional policies to

facilitate voluntary band clearing

agreements among incumbent

broadcasters and new wireless

licensees.

2. Cost-Sharing Rules. The

Commission concludes that it is not

necessary or appropriate to adopt costsharing rules to assist in clearing the

700 MHz band. Based on the record, the

Commission finds that the new 700

MHz commercial wireless licensees

should be able to enter into cost-sharing

agreements without Commission rules.

Therefore, the Commission leaves all

cost-sharing arrangements to

negotiations among successful auction

bidders in this band.

3. Three-Way Voluntary Transition

Agreements. The Commission adopts a

general presumption, standards of

review, and policies for three-way

agreements among incumbent Channel

59–69 broadcasters and new 700 MHz

wireless licensees that are similar to

those adopted in the 700 MHz MO&O

and FNPRM for bilateral agreements

between broadcasters and new 700 MHz

wireless licensees. Three-way band

clearing agreements would provide for

TV incumbents in the 700 MHz band to

relocate their operations to lower band

TV channels that would be voluntarily

cleared by the lower band TV

incumbents. The Commission finds that

adopting guidelines for three-way

agreements similar to those established

for bilateral agreements should help

negotiating parties and serve the public

interest by providing a measure of

certainty regarding the conditions under

which a regulatory request to implement

a three-way agreement may be

approved. The presumption the

Commission will apply to three-way

agreements will be the same as the

presumption adopted for bilateral

agreements. Thus, the Commission will

presume that the public interest is

substantially furthered when an

applicant demonstrates that the grant of

its request will both result in certain

specific benefits and avoid specific

detriments. To obtain this presumption,

an applicant must first demonstrate that

grant of its request would result in one

of the following: (i) Make new or