Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations 33179

EPA has determined that the approval

action promulgated does not include a

Federal mandate that may result in

estimated costs of $100 million or more

to either State, local, or tribal

governments in the aggregate, or to the

private sector. This Federal action acts

on pre-existing requirements under

State or local law, and imposes no new

requirements. Accordingly, no

additional costs to State, local, or tribal

governments, or to the private sector,

result from this action.

G. National Technology Transfer and

Advancement Act

Section 12 of the National Technology

Transfer and Advancement Act

(NTTAA) of 1995 requires Federal

agencies to evaluate existing technical

standards when developing a new

regulation. To comply with NTTAA,

EPA must consider and use ‘‘voluntary

consensus standards’’ (VCS) if available

and applicable when developing

programs and policies unless doing so

would be inconsistent with applicable

law or otherwise impractical.

EPA believes that VCS are

inapplicable to today’s action because it

does not require the public to perform

activities conducive to the use of VCS.

H. 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 the rule in

the Federal Register. A major rule

cannot take effect until 60 days after it

is published in the Federal Register.

This rule is not a ‘‘major’’ rule as

defined by 5 U.S.C. 804(2).

I. Petitions for Judicial Review

Under section 307(b)(1) of the Clean

Air Act, petitions for judicial review of

this action must be filed in the United

States Court of Appeals for the

appropriate circuit by August 20, 2001.

Filing a petition for reconsideration by

the Administrator of this final rule does

not affect the finality of this rule for the

purposes of judicial review nor does it

extend the time within which a petition

for judicial review may be filed, and

shall not postpone the effectiveness of

such rule or action. This action may not

be challenged later in proceedings to

enforce its requirements. (See section

307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Incorporation by

reference, Intergovernmental relations,

Ozone, Reporting and recordkeeping

requirements, Volatile organic

compounds.

Dated: May 24, 2001.

Jane Diamond,

Acting Regional Administrator, Region IX.

Part 52, chapter I, title 40 of the Code

of Federal Regulations is amended as

follows:

PART 52—[AMENDED]

1. The authority citation for Part 52

continues to read as follows:

Authority: 42 U.S.C. 7401 et seq.

Subpart F—California

2. Section 52.269 is amended by

adding paragraph (b)(3)(iii) to read as

follows:

§ 52.269 Control strategy and regulations:

Photochemical oxidants (hydrocarbons)

and carbon monoxide.

* * * * *

(b) * * *

(3) * * *

(iii) Antelope Valley APCD.

(A) Rule 461, Gasoline Transfer and

Dispensing, submitted on May 13, 1999,

is disapproved. The version of this rule

submitted on January 31, 1996 (same

title and number), which was previously

approved in 40 CFR 52.220, is retained.

* * * * *

[FR Doc. 01–15617 Filed 6–20–01; 8:45 am]

BILLING CODE 6560–50–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301135; FRL–6786–1]

RIN 2070–AB78

Isoxadifen-ethyl; Time-Limited

Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for combined

residues of the safener isoxadifen-ethyl

in or on rice, grain; rice, straw; rice,

hulls; and rice, bran. Aventis

CropScience requested this tolerance

under the Federal Food, Drug, and

Cosmetic Act (FFDCA), as amended by

the Food Quality Protection Act (FQPA)

of 1996. The tolerance will expire on

June 21, 2004.

DATES: This regulation is effective June

21, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301135, must be received

by EPA on or before August 20, 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–301135 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Vera Soltero, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–9359; and e-mail address:

soltero.vera@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.

33180 Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations

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. 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–301135. 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 Registers of June 9,

1999 (64 FR–30997) (FRL–6082–6) and

June 30, 2000 (65 FR–40632) (FRL–

6592–6), EPA issued notices pursuant to

section 408 of the FFDCA, 21 U.S.C.

346a as amended by the FQPA of 1996

(Public Law 104–170) announcing the

filing of a pesticide petition (PP 9E5060)

for tolerance by Aventis CropScience,

P.O. Box 12014, 2 T.W. Alexander Dr.,

Research Triangle Park, NC 27709.

These notices included a summary of

the petition prepared by Aventis

CropScience, the petitioner. There were

no comments received in response to

these notices of filing.

The petition requested that 40 CFR

180.570 be amended by establishing a

tolerance for the combined residues of

the safener isoxadifen-ethyl, (ethyl 5,5-

diphenyl-2-isoxazoline-3-carboxylate,

CAS No. 163520–33–0) and its

metabolites: 4,5-dihydro-5,5-diphenyl-3-

isoxazolecarboxylic acid and β-hydroxyβ-benezenepropanenitrile, in or on rice,

grain; and rice, straw at 0.050 and 0.20

part per million (ppm) respectively. The

Agency determined that the tolerance

levels should be raised and that

tolerances for two additional rice

commodities are appropriate due to the

lack of a rice processing study. Thus,

the tolerance levels for the safener

isoxadifen-ethyl and its metabolites for

the following commodities are: rice,

grain; rice, straw; rice, hulls; and rice,

bran at 0.10, 0.25, 0.50, and 0.80 ppm

respectively. The tolerances will expire

on June 21, 2004.

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 the

combined residues of isoxadifen-ethyl

and its metabolites on rice, grain; rice,

straw; rice, hulls; and rice, bran at 0.10,

0.25, 0.50, and 0.80 ppm respectively.

EPA’s assessment of exposures and risks

associated with establishing the

tolerances follow.

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 on 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 isoxadifen-ethyl

are discussed in the following Table 1

as well as the no observed adverse effect

level (NOAEL) and the lowest observed

adverse effect level (LOAEL) from the

toxicity studies reviewed.

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results

870.3100 90–Day oral toxicity

mouse

NOAEL = 19.8 miligram/killogram/day(mg/kg/day) in males, 254 mg/kg/day in females

LOAEL = 191 mg/kg/day in males, 573 mg/kg/day infemales based on pathological

changes in the liverconsisting of hepatocellular hypertrophy, hepatocellularvacuolation

and fatty deposits in liver (males and females).

Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations 33181

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

Guideline No. Study Type Results

870.3100 90–Day oral toxicity

rodents- rat

NOAEL = 13.8 mg/kg/day in males, 333.2mg/kg/day in females highest dose tested

(HDT)

LOAEL = 137.9 mg/kg/day in males based on decreasedbody weight and body weight

gain.

870.3150 90–Day oral toxicity in

nonrodents-dog

NOAEL = 1.2 mg/kg/day in males, 6.5mg/kg/day in females.

LOAEL = 6.1 mg/kg/day in males, and 47.5 mg/kg/day infemales based on slight fat deposits in the collecting ductsof the kidney and aspermia (males) and decreased bodyweight gain, differences in various hematological parameters,and moderate fat deposits in the collecting ducts of the kidneys (females).

870.3200 28–Day dermal toxicity NOAEL= 1,000 mg/kg/day LOAEL= not established

870.3700a Prenatal developmental

in rodents-rat

Maternal NOAEL = 120 mg/kg/day

LOAEL = 1,000 mg/kg/day based on mortality,and reduced body weight, body weight

gain and food consumption.

Developmental NOAEL = 15 mg/kg/day

LOAEL = 120 mg/kg/day based on increased incidence ofbent scapula.

870.3700b Prenatal developmental

in nonrodents-rabbit

Maternal NOAEL = 50 mg/kg/day

LOAEL = 500 mg/kg/day based on mortality.

Developmental NOAEL = 50 mg/kg/day

LOAEL = 500 mg/kg/day based on increased litterincidence of fused, aplastic, dislocated

or fragmentedcaudal vertebrae centers.

70.3800 Reproduction and fertility effects- ratParental/Systemic NOAEL = 12.6 mg/kg/dayin males, 16.7 mg.kg.day in females

LOAEL = 249.8 mg/kg/day in males, 346.5 mg/kg/day infemales based on decreased

body weight and body weightgain and increased kidney lesions in males and females.

Reproductive NOAEL ≥249.8 mg/kg/day in males, 346.5mg/kg/day in females

LOAEL = not established

Offspring NOAEL = 12.6 mg/kg/day in males, 16.7mg/kg/day in females

LOAEL = 249.8 mg/kg/day in males, 346.5 mg/kg/day in females based on decreased

body weight in male pups and delayed sexual maturation in males and females.

870.4100b Chronic toxicity dogs NOAEL = 3.3 mg/kg/day in males, 3.6mg/kg/day in females

LOAEL = 24 mg/kg/day based on increased bloodcreatinine in females, decreased urinary specific graviy inboth sexes, increased partial thromboplastin time in bothsexes,

and increased incidence and severity of straighttubule vacuolation in the kidney of

both sexes.

870.4200 Carcinogenicity rats NOAEL = 84 mg/kg/day in males, 118mg/kg/day in females

LOAEL = 171 mg/kg/day in males, 249 mg/kg/day infemales based on decreases in

body weight and bodyweight gain for both sexes, proteinaceous plugs in theurinary

bladder of males and increased severity ofprogressive nephropathy in females.

No evidence of carcinogenicity

870.4300 Carcinogenicity mice NOAEL = 16.6 mg/kg/day in males, 202.5 mg/kg/day in females

LOAEL = 169.6 mg/kg/day in males, 407.3 mg/kg/day infemales based on significant decreased survival in males and females.

No evidence of carcinogenicity

870.5265 Gene mutation Non-mutagenic when tested yp to 5,000μg/plate, in presence and absence of activation,

inS.typhimurium strains TA98, TA1000, TA1535 and TA1537and E.coli strain

WP2uvra.

870.5300 Cytogenetics Non-mutagenic at the HGPRT locus inChinese hamster (CH) lung V79 cells tested up to

cytotoxicconcentrations or limit of solubility, in presence andabsence of activation.

870.5375 Chromosome aberration Did not induce structural chromosomeaberration in CH lung V79 cell cultures in

theabsence of activation, but did induce increased levels ofnumerical aberrations, in

presence of activation.

870.5395 Micronucleus Non-mutagenic in mouse bone marrowmicronucleus assay up to 200 mg/kg.

870.5550 Unscheduled DNA synthesisThere was no evidence that unschedulesDNA synthesis, as determined by radioactive

tracerprocedures (nuclear silver grain counts) was induced in ratsexposed up to 2,000

mg/kg (limit dose).

870.7485 Metabolism and pharmacokineticsAbsorption was 46% in males and 82% infemales. Urinary excretion was the primary

route ofelimination. Fecal excretion was greater in males thanfemales. The free acid

and hydroxy free acid were theprincipal components detected in excreta.

33182 Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations

B. Toxicological Endpoints

The dose at which no observed

adverse effect level (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.

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR ISOXADIFEN-ETHYL FOR USE IN HUMAN RISK

ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF

FQPA SF* and Level of Concern

for RiskAssessment Study and Toxicological Effects

Acute dietaryfemales 13–50

years of age

NOAEL = 15 mg/kg/day

UF = 100

Acute RfD = 0.15 mg/kg/

day

FQPA SF = 3X

aPAD = acute RfD ∞

FQPA SF = 0.05 mg/kg/day

Developmental toxicity - rat

LOAEL = 120 mg/kg/daybased on increased

incidence of bent scapula.

Chronic dietaryall populations NOAEL = 3.3 mg/kg/day

UF = 100

Chronic RfD = 0.033 mg/

kg/day

FQPA SF = 1X

cPAD = chronic RfD ∞

FQPA SF = 0.033 mg/kg/day

Subchronic toxicity (feeding) - dog;chronic

toxicity (feeding) - dog

LOAEL = 6.1 mg/kg/day based on fat deposits incollecting ducts of nephron (males).

Short-termdermal (1 to 7 days)

(occupational)

Oral study NOAEL= 13.8

mg/kg/day

(dermalabsorption rate

= 14%)

LOC for MOE = 100 (occupational)90–Day feeding study - rat

LOAEL = 137.9 mg/kg/day based on decreased bodyweight and body weight gain

after 8 days of exposure (males).

Intermediate-termdermal (1

week to several months) occupational)

Oral study NOAEL = 3.3

mg/kg/day (dermal absorption rate = 14%)

LOC for MOE = 100 Subchronic toxicity (feeding) - dog (co-critical); chronictoxicity (feeding) - dog

LOAEL = 6.1 mg/kg/day based on fat deposits in collecting ducts of nephron (males).

Short-term inhalation(1 to 7

days) (occupational)

Oral study

NOAEL=13.8 mg/kg/day

(inhalation absorption

rate = 100%)

LOC for MOE = 100 90–Day feeding study - rat

LOAEL = 137.9 mg/kg/daybased on decreased body weight and body weight

gainafter 8 days of exposure (males).

Intermediate-terminhalation (1

week to several months)

(occupational)

Oral study NOAEL = 3.3

mg/kg/day(inhalation

absorption rate = 100%)

LOC for MOE = 100 Subchronic toxicity (feeding) - dogco-critical);

chronic toxicity (feeding) - dog

LOAEL = 6.1 mg/kg/day based on fat deposits incollecting ducts of nephron (males).

Cancer (oral, dermal, inhalation)Cancer classification (‘‘not

likely’’)

Risk assessment not required. No evidence of carcinogenicity

* 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. There are no permanent or

time-limited tolerances for isoxadifenethyl. Tolerances are unnecessary for

ruminant or poultry commodities at this

time. Risk assessments were conducted

by EPA to assess dietary exposures from

isoxadifen-ethyl 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. The Dietary

Exposure Evaluation Model (DEEM)

analysis evaluated in 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 copnservative

acute analysis was performed using

tolerance level residues, default

processing factors, and assuming 100%

of the crops were. No anticipated

residues were used. In addition, to

account for the lack of rotational crop

data, a value of 0.25 ppm for soybean

seed was used inthe DEEM analysis

along with maximum theoretical

concentration factors for soybean meal

(2.2X), hulls (11.3X), and oil (12.0X).

For acute dietary risk, the Agency’s

level of concern is > 100% aPAD. The

acute dietary exposure estimate for the

females 13–50 years old subgroup, at the

95th percentile of exposure, is 5% aPAD,

Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations 33183

which is below the Agency’s level of

concern.

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 chronic

dietary exposure analysis made use of

the same assumptions that went into the

acute dietary previously described. For

chronic dietary risk, the Agency’s level

of concern is >100% cPAD. Dietary

exposure estimates for representative

population subgroups are presented

below:

TABLE 3.—SUMMARY OF RESULTS FROM CHRONIC DEEM ANALYSIS OF ISOXADIFEN-ETHYL

Subgroup Exposure (mg/kg/day) % cPAD

U.S. population (total) 0.001297 4

All infants (< 1–year old) 0.005080 15

Children 1–6 years old 0.002458 7

Children 7–12 years old 0.001952 6

Females 13–50 years old 0.001001 3

Males 13–19 years old 0.001483 5

Males 20+ years old 0.001035 3

Seniors 55+ years old 0.000854 3

The results of the chronic analysis

indicate that for all population

subgroups the estimated chronic dietary

risk associated with the uses of

isoxadifen-ethyl is below the Agency’s

level of concern.

iii. Cancer. After consideration of the

Agency’s ‘‘Proposed Guidelines for

Carcinogen Risk Assessment (April 10,

1996),’’ EPA has classified isoxadifenethyl as ‘‘not likely to be a human

carcinogen.’’ This classification is based

on the lack of evidence of

carcinogenicity in mice and rats.

Therefore, a cancer risk analysis is not

necessary.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

isoxadifen-ethyl 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

isoxadifen-ethyl.

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 (PC) area

factor as an adjustment to account for

the maximum PC coverage within a

watershed or drainage basin.

None of these models include

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever exceed human health levels of

concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a %RfD or %PAD.

Instead drinking water levels of

comparison (DWLOCs) are calculated

and used as a point of comparison

against the model estimates of a

pesticide’s concentration in water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food, and from

residential uses. Since DWLOCs address

total aggregate exposure to isoxadifenethyl they are further discussed in the

aggregate risk sections below.

Based on the GENEEC and SCI-GROW

models, the estimated environmental

concentrations (EECs) of isoxadifenethyl for acute exposures are estimated

to be 80 parts per billion (ppb) for

surface water and 5 ppb for ground

water. The EECs for chronic exposures

are estimated to be 40 ppb for surface

water and 5 ppb for ground water. It has

been determined that the 56–day

GENEEC model estimate would

routinely overestimate drinking water

residues by at least a factor of three.

Therefore, the chronic exposure

estimate for surface water (40 ppb) was

divided by 3 in Table 5 below.

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). There are

no residential uses of isoxadifen-ethyl.

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

isoxadifen-ethyl has a common

mechanism of toxicity with other

substances or how to include this

pesticide in a cumulative risk

33184 Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations

assessment. Unlike other pesticides for

which EPA has followed a cumulative

risk approach based on a common

mechanism of toxicity, isoxadifen-ethyl

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 isoxadifen-ethyl 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.

Based in the available data, both

quantitative and qualitative evidence of

increased susceptibility was observed

following in utero isoxadifen-ethyl

exposure to rats. In the prenatal rat

developmental toxicity study, the

developmental toxicity NOAEL/LOAEL

of 15/120 mg/kg/day occurs below level

of the maternally toxic NOAEL/LOAEL

of 120/1,000 mg/kg/day. This finding

established the quantitative

susceptibility for isoxadifen-ethyl.

Additionally, the developmental effect

observed (increased incidence of bent

scapula) is considered more severe and

permanent that the maternal effects of

reduced body weight, body weight gain

and food consumption. The finding

established the qualitative susceptibility

for isoxadifen-ethyl. However, there was

no evidence of increased susceptibility

in the rabbit prenatal toxicity study or

following prenatal/postnatal exposure

in the 2-generation reproduction study.

iii. Conclusion. EPA determined that

the 10X safety factor would be reduced

to 3X because the toxicology data base

is complete; a developmental

neurotoxicity study was not required;

the dietary (food and drinking water)

exposure assessments will not

underestimate the potential exposures

for infants and children; and there are

currently no residential uses.

The FQPA safety factor for isoxadifenethyl is applicable to females 13–50

population subgroup for acute dietary

risk assessment since there is concern

for increased susceptibility of the

young, as demonstrated in the prenatal

developmental study in rats.

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

calculatedDWLOCs, 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. The acute dietary

exposure analysis assumed tolerance

level residues and 100% crop treated for

all proposed commodities, in addition

to estimating from possible

contributions from soybeans based on

the rotational crop use. Using the

exposure assumptions discussed in this

unit for acute exposure, the acute

dietary exposure from food to

isoxadifen-ethyl will occupy 5% of the

aPAD for females 13 years and older. In

addition, there is potential for acute

dietary exposure to isoxadifen-ethyl in

drinking water. The EECs for surface

and ground water are less than the

DWLOC. Thus, EPA does not expect the

aggregate exposure to exceed 100% of

the aPAD, as shown in Table 4:

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO ISOXADIFEN-ETHYL

Population Subgroup aPAD (mg/kg) %aPAD (Food) Surface Water

EEC (ppb)

Ground Water

EEC (ppb)

Acute DWLOC

(ppb)

Females 13–50years old 0.050 5 80 5 14,000

2. Chronic risk. The chronic exposure

analysis assumed tolerance level

residues and 100% crop treated for all

commodities, in addition to estimating

from possible contributions from

soybeans based on the rotational crop

use. Using the exposure assumptions

described in this unit for chronic

exposure, EPA has concluded that

exposure to isoxadifen-ethyl from food

will utilize 4% of the cPAD for the U.S.

population, 15% of the cPAD for all

infants and 7% of the cPAD for children

1–6 years old. There are no residential

uses for isoxadifen-ethyl that result in

Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations 33185

chronic residential exposure to

isoxadifen-ethyl. In addition, there is

potential for chronic dietary exposure to

isoxadifen-ethyl in drinking water. The

EECs for surface and ground water are

less than the DWLOC. Thus, EPA does

not expect the aggregate exposure to

exceed 100% of the cPAD, as shown in

Table 5:

TABLE 5.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO ISOXADIFEN-ETHYL

Population Subgroup cPAD mg/kg/day %cPAD (Food) Surface Water

EEC (ppb)

Ground Water

EEC (ppb)

Chronic DWLOC

(ppb)

U.S. population 0.033 4 13 5 1100

All infants (<1 year old) 0.033 15 13 5 280

Children (1–6 years old) 0.033 7 13 5 310

Children (7–12 years old) 0.033 6 13 5 310

Females (13–50 years old) 0.033 3 13 5 960

Males (13–19 years old) 0.033 5 13 5 1100

Males (20+ years old) 0.033 3 13 5 1100

Seniors (55+ years old) 0.033 3 13 5 1100

3. Short-term risk. Short-term

aggregate exposure takes into account

residential exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Isoxadifen-ethyl is not registered for use

on any sites that would result in

residential exposure. Therefore, no

short-term risk assessment was

performed.

4. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account residential exposure

plus chronic exposure to food and water

(considered to be a background

exposure level). Isoxadifen-ethyl is not

registered for use on any sites that

would result in residential exposure.

Therefore, no intermediate-term risk

assessment was performed.

5. Aggregate cancer risk for U.S.

population. The Agency has classified

isoxadifen-ethyl as ‘‘not likely to be a

carcinogen.’’ Therefore, an aggregate

cancer risk assessment was not

performed.

6. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, and to infants and children

from aggregate exposure to combined

residues of isoxadifen-ethyl and its

metabolites.

IV. Other Considerations

A. Analytical Enforcement Methodology

The petitioner proposed using a

multiresidue method (MRM) for

enforcement of tolerances of isoxadifenethyl residues and its metabolites on

rice. Data were submitted pertaining to

the behavior of isoxadifen-ethyl using

FDA MRM protocols (PAM Vol 1).

Residues of the parent compound were

recovered from rice using Protocol E,

Method 303. There were also

quantitative recoveries of 4,5-dihydro5,5-diphenyl-3-isoxazolecarboxylic acid

(metabolite 1) using protocol B. No

results concerning the behavior of

metabolite β-hydroxy-β

benezenepropanenitrile (metabolite 2)

in rice using the multiresidue protocols

were reported.

The petitioner also submitted an

Independent Laboratory Validation

(ILV) for the parent and metabolite 2 in

rice grain, using gas chromatography

with a mass-selective detector (GC/

MSD). Validation of this method was

successful.

At this time there is not one analytical

method that can detect the parent and

both metabolites in rice. However, if a

situation should arise, then the Agency

could perform both the MRM and the

GC/MSD methods which would detect

residues of isoxadifen-ethyl and both its

metabolites in rice.

The Agency is requiring the petitioner

to resubmit the analytical method and

an ILV for the parent and both of the

metabolites to satisfy the requirement

for an enforcement analytical method.

Following successful Agency validation

of the MRM and the enforcement

analytical methods, and review and

evaluation of the other required data,

the Agency will consider establishing

permanent tolerances.

B. International Residue Limits

There are no CODEX, Canadian, or

Mexican tolerances/MRLs for

isoxadifen-ethyl residues.

C. Conditions

The following data are required to

establish permanent tolerances for

isoxadifen-ethyl: Confined/field

accumulation in rotational crops study;

rice processed commodity study;

successful method validation of the

analytical enforcement method; and

adequate storage stability data.

Additionally, as a condition of

registration, rotational crops are limited

to soybeans and there will be a 9–month

plantback interval for isoxadifen-ethyl

in rice agricultural commodities.

V. Conclusion

Therefore, the time-limited tolerances

are established for combined residues of

isoxadifen-ethyl, and its metabolites, in

or on rice, grain; rice, straw; rice, hulls;

and rice, bran at 0.10, 0.25, 0.50 and

0.80 ppm respectively.

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

33186 Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations

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–301135 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 20, 2001.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(s) on which a hearing

is requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the objector (40

CFR 178.27). Information submitted in

connection with an objection or hearing

request may be claimed confidential by

marking any part or all of that

information as CBI. Information so

marked will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the

information that does not contain CBI

must be submitted for inclusion in the

public record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, 1200 Pennsylvania

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

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. The Office of

the Hearing Clerk is open from 8 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The telephone

number for the Office of the Hearing

Clerk is (202) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

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

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

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

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket control

number OPP–301135, 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 OMB review or

any other 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

Federal Register / Vol. 66, No. 120 / Thursday, June 21, 2001 / Rules and Regulations 33187

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

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

For these same reasons, the Agency has

determined that this rule does not have

any ‘‘tribal implications’’ as described

in Executive Order 13175, entitled

Consultation and Coordination with

Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

‘‘meaningful and timely input by tribal

officials in the development of

regulatory policies that have tribal

implications.’’ ‘‘Policies that have tribal

implications’’ is defined in the

Executive Order to include regulations

that have ‘‘substantial direct effects on

one or more Indian tribes, on the

relationship between the Federal

government and the Indian tribes, or on

the distribution of power and

responsibilities between the Federal

government and Indian tribes.’’ This

rule will not have substantial direct

effects on tribal governments, on the

relationship between the Federal

government and Indian tribes, or on the

distribution of power and

responsibilities between the Federal

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.

VIII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

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

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of this final

rule in the Federal Register. This final

rule is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: June 11, 2001.

Peter Caulkins,

Acting 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 180.570 is added to read as

follows:

§ 180.570 Isoxadifen-ethyl; tolerances for

residues.

(a) General. Tolerances to expire on

June 21, 2004 are established for

residues of isoxadifen-ethyl (ethyl 5,5-

diphenyl-2-isoxazoline-3-carboxylate,

CAS No. 163520–33–0) and its

metabolites: 4,5-dihydro-5,5-diphenyl-3-

isoxazolecarboxylic acid and β-hydroxyβ-benezenepropanenitrile when in the

commodities listed below. This safener

will be used only in conjunction with

the active ingredient fenoxaprop-pethyl, at a rate of 0.17 pound of safener

per pound of active ingredient.

Commodity Parts per million Expiration/Revocation Date

Rice, bran ............................... 0.80 ppm June 21, 2004

Rice, grain .............................. 0.10 ppm June 21, 2004

Rice, hulls ............................... 0.50 ppm June 21, 2004

Rice, straw .............................. 0.25 ppm June 21, 2004

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 01–15613 Filed 6–20–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301138; FRL–6787–7]

RIN 2070–AB78

Mesotrione; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for residues ofmesotrione, 2-

[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-

cyclohexanedione, in or on field corn.

Syngenta Crop Protection Inc. requested

this tolerance under the Federal Food,

Drug, and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996.

DATES: This regulation is effective June

21, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301138, must be received

by EPA on or before August 20, 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 numberOPP–301138 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne Miller,Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave.,

NW.,Washington, DC 20460; telephone

number: 703-305-6224; and e-mail

address: Miller.Joanne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing