Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Rules and Regulations 29963

List of Subjects

40 CFR Part 52

Environmental protection, Air

pollution control, Intergovernmental

relations, Lead, Reporting and

recordkeeping requirements.

40 CFR Part 81

Environmental protection, Air

pollution control, National parks,

Wilderness areas.

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

Dated: April 20, 2000.

Francis X. Lyons,

Regional Administrator, Region 5.

For the reasons stated in the

preamble, title 40, Chapter I of the Code

of Federal Regulation are 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 P—Indiana

2. Section 52.797 is amended by

removing the introductory text and

adding paragraph (d) to read as follows:

§ 52.797 Control strategy: Lead.

* * * * *

(d) On March 2, 2000, Indiana

submitted a maintenance plan for

Marion County as part of its request to

redesignate the County to attainment of

the lead standard.

* * * * *

PART 81—[AMENDED]

1. The authority citation for part 81

continues to read as follows:

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

Subpart C—Section 107 Attainment

Status Designations

2. The table in § 81.315 entitled

‘‘Indiana Lead’’ is amended to read as

follows:

§ 81.315 Indiana.

* * * * *

INDIANA—LEAD

Designated area

Designation Classification

Date Type Date Type

Marion County (Part)—Part of Franklin Township: Thompson

Road on the south; Emerson Avenue on the west; Five

Points Road on the East; and Troy Avenue on the north.

July 10,

2000

Attainment.

Marion County (Part)—Part of Wayne Township: Rockville

Road on the north; Girls School Road on the east; Washington Street on the south; and Bridgeport Road on the

west.

July 10,

2000

Attainment.

Rest of State Not Designated.

*******

* * * * *

[FR Doc. 00–11423 Filed 5–9–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300994; FRL–6555–5]

RIN 2070–AB78

Myclobutanil; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for combined residues of

myclobutanil in or on a variety of food

commodities. Rohm and Haas Company

and the Interregional Research Project

#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 May

10, 2000. Objections and requests for

hearings, identified by docket control

number OPP–300994, must be received

by EPA on or before July 10, 2000.

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–300994 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Hoyt Jamerson, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, Ariel Rios Bldg., 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–9368; and e-mail address:

jamerson.hoyt@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you sell, distribute, manufacture, or use

pesticides for agricultural applications,

process food, distribute or sell food, or

implement governmental pesticide

regulations. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

29964 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / 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’’ 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/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–300994. 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 September

2, 1999 (64 FR 48165) (FRL–6049–5),

EPA issued a notice pursuant to section

408 of the Federal Food, Drug, and

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

as amended by the Food Quality

Protection Act of 1996 (FQPA) (Public

Law 104–170) announcing the filing of

pesticide petitions (PP) for tolerances by

Rohm and Haas Company and IR–4.

This notice included a summary of the

petitions prepared by Rohm and Haas

Company, the registrant. There were no

comments received in response to the

notice of filing.

The petitions requested that 40 CFR

180.443 be amended by establishing

tolerances for combined residues of the

fungicide myclobutanil alpha-butylalpha-(4-chlorophenyl)-1H-1,2,4-

triazole-1-propanenitrile and its alcohol

metabolite (alpha-(3-hydroxybutyl)-

alpha-(4-chlorophenyl)-1H-1,2,4-

triazole-1-propanenitrile (free and

bound), in or on the following

commodities:

1. PP 7E4862. IR–4 proposes the

establishment of a tolerance for

asparagus at 0.02 parts per million

(ppm).

2.PP 7E4866. IR–4 proposes the

establishment of a tolerance for the

caneberry subgroup at 1.0 ppm. The

petition was subsequently amended to

propose the establishment of a tolerance

for the caneberry subgroup at 2.0 ppm.

3. PP 8E4939. IR–4 proposes the

establishment of tolerances for currant

at 3.0 ppm and gooseberry at 2.0 ppm.

4. PP 7E4877. IR–4 proposes the

establishment of a tolerance for mint at

3.0 ppm. The petition was revised to

specify peppermint and spearmint tops

at 3.0 ppm.

5. PP 7E4861. IR–4 proposes the

establishment of a tolerance for snap

beans at 1.0 ppm. The petition was

amended to proposed a tolerance for

succulent snap bean at 1.0 ppm.

6. PP 4E4302. IR–4 proposes the

establishment of a tolerance for

strawberry at 0.5 ppm.

7. PP 1F4030. Rohm and Haas

Company proposes the establishment of

tolerances for tomato at 0.3 ppm, tomato

puree at 0.6 ppm and tomato paste at 1.2

ppm. The petition was subsequently

amended to propose tolerances for

tomato at 0.3 ppm, tomato puree at 0.5

ppm and tomato paste at 1.0 ppm.

8. PP 9F3812. Rohm and Haas

Company proposes the establishment of

a tolerance for the pome fruit group at

0.5 ppm. The petition was amended to

propose a tolerance for mayhaw at 0.7

ppm and apple wet pomace at 1.3 ppm.

9. PP 2F4155. Rohm and Haas

Company proposes the establishment of

tolerances for the cucurbit vegetables

group at 0.5 ppm. The petition was

amended to propose a tolerance for the

cucurbit vegetables group at 0.2 ppm.

The petition was also amended to

propose tolerances for indirect and

inadvertent residues of myclobutanil

(parent compound only) at 0.03 ppm for

the following rotational crop groups:

root and tuber vegetables group; leaves

of root and tuber vegetables group; leafy

vegetables (except Brassica vegetables)

group; Brassica leafy vegetables group;

legume vegetables group; foliage of

legume vegetables group; fruiting

vegetables group; cereal grains group;

forage, fodder and straw of cereal grains

group; and the nongrass animal feeds

group.

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 food and 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 tolerances for

residues of myclobutanil on the named

commodities. EPA’s assessment of

exposures and risks associated with

establishing the tolerances 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 myclobutanil are

discussed in this unit as well as the no

observed adverse effect level (NOAEL)

and the lowest observed adverse effect

level (LOAEL) from the toxicity studies

reviewed.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Rules and Regulations 29965

TABLE 1.— TOXICITY PROFILE OF MYCLOBUTANIL TECHNICAL

Guideline/Study Results

82–1(a) Subchronic Feeding in Rats (13 weeks) .................... NOAEL: 1000 ppm

LOAEL: 3000 ppm based on increased liver, kidney weights; hypertrophy, necrosis in liver; pigmentation in convoluted kidney tubules; vacuolated adrenal cortex.

82–1(a) Subchronic Feeding in Mice (13 weeks) .................... NOAEL: 45 mg/kg/day( 300 ppm)

LOAEL: 150 mg/kg/day (1000 ppm) based on hepatocytic hypertrophy, swollenvacuolated centrilobular hepatocytes, single large hepatocyte vacuoles,

centrilobular individual cell hepatocyte necrosis and centrilobular necrotic hepatitis; cytoplasmic eosinophilia and/or hypertrophy of the zona fasculata cells of

the adrenal glands of males.

82–1(b) Subchronic Feeding in Dogs (13 Weeks) .................. NOAEL: 5 mg/kg/day (200 ppm)

LOAEL: 20 mg/kg/day (800 ppm) based on liver changes including increased alkaline phosphatase, relative and absolute liver weight and hepatocellular hypertrophy.

82–2 28–day Dermal Toxicity in Rats ...................................... NOAEL for systemic effects: greater than 100 mg a.i./kg/day (the highest dose in

both studies)

LOAEL: not established

NOTE: this was conducted in 2 formulations rather than the technical (40WP -

41.36%; 2EC - 24.99%).

83–1(b) Chronic Feeding Study in Dogs ................................. NOAEL: 3.09 mg/kg/day (100 ppm)

LOAEL: 14.28 mg/kg/day (400 ppm) based on hepatocellular hypertrophy, increases in liver weights, ‘‘ballooned’’ hepatocytes and increases in alkaline

phosphatase, SGPT and GGT. In addition, there were some possible slight

hematological effects.

83–2(b) Carcinogenicity study in mice ..................................... NOAEL: 13.7 mg/kg/day (100 ppm) for males

LOAEL: 70.2 mg/kg/day (500 ppm in males); not established in females. There

were increased MFO (males and females); increased SGPT (females) & increased absolute & relative liver weights (males and females); increased

incidences and severity of centrilobular hepatocytic hypertrophy, Kupffer cell

pigmentation, periportal punctate vacuolation & individual hepatocellular necrosis (males); and increased incidences of focal hepatocellular alterations and

multifocal hepatocellular vacuolation (males and females). Not tested at high

enough dose levels in females. In a second carcinogenicity study in mice, female mice were tested at sufficiently high dose levels (2000 ppm (393.5 mg/

kg/day)), no carcinogenic effects observed.

83–2(b) Carcinogenicity study in mice ..................................... NOAEL: Not established

LOAEL: 2000 ppm (393.5 mg/kg/day) (only dose tested) based on decreases in

body weight and body weight gain; increases in liver weights; hepatocellular

hypertrophy; hepatocellular vacuolation; necrosis of single hypertrophied

hepatocytes; yellow-brown pigment in the Kupffer cells and cytoplasmic

eosinophilia and hypertrophy of the cells of the zona fasciculata area of the adrenal cortex. Not carcinogenic under the conditions of the study.

83–5 Chronic Feeding/carcinogenicity study in rats ................ NOAEL: 2.49 mg/kg/day (50 ppm)

LOAEL: 9.94 mg/kg/day (200 ppm) based on decreased testes weights and increased testicular atrophy. Not tested at high enough dose levels. In a second

chronic feeding/carcinogenicity study in rats, rats were tested at sufficiently

high dose levels (2500 ppm: 125 mg/kg/day), no carcinogenic effects observed.

83–5 Chronic feeding/carcinogenicity study in rats ................. NOAEL: Not established

LOAEL: 125 mg/kg/day (2500 ppm) (only dose tested) based on testicular atrophy and decreases in testes weights; increases in the incidences of

centrilobular to midzonal hepatocellular enlargement and vacuolization in the

liver of both sexes; increases in bilateral aspermatogenesis in the testes; increases in the incidence of hypospermia and cellular debris in the

epididymides; and increased incidence of arteritis/periarteritis in the testes). No

carcinogenic effects observed.

83–3(a) Developmental Toxicity Study in Rats ........................ Maternal NOAEL: 93.8 mg/kg/day

Maternal LOAEL: 312.6 mg/kg/day based on rough hair coat and salivation at

312.6 mg/kg/day and salivation, alopecia, desquamation and red exudate

around mouth at 468.87 mg/kg/day.

Developmental NOAEL: 93.8 mg/kg/day Developmental LOAEL: 312.6 mg/kg/day

based on increased incidences of 14th rudimentary and 7th cervical ribs at

312.6 and 468.9 mg/kg/day.

83–3(b) Developmental Toxicity Study in Rabbits ................... Maternal NOAEL: 60 mg/kg/day

Maternal LOAEL: 200 mg/kg/day based on reduced body weight and body weight

gain during the dosing period, clinical signs of toxicity and possibly abortions.

Developmental NOAEL: 60 mg/kg/day

Developmental LOAEL: 200 mg/kg/day based on increases in number of resorptions, decreases in litter size and a decrease in the viability index.

29966 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Rules and Regulations

TABLE 1.— TOXICITY PROFILE OF MYCLOBUTANIL TECHNICAL—Continued

Guideline/Study Results

83–4 2-Generation Reproduction Toxicity in Rats ................... Systemic NOAEL: 2.5 mg/kg/day (50 ppm)

Systemic LOAEL: 10 mg/kg/day (200 ppm) based on increased liver weights and

hepatocellular hypertrophy.

Reproductive NOAEL: 10 mg/kg/day (200 ppm)

Reproductive LOAEL: 50 mg/kg/day (1000 ppm) based on increased incidence in

the number of stillborns and atrophy of the testes, epididymides and prostate.

Developmental NOAEL: 10 mg/kg/day (200 ppm)

Developmental LOAEL: 1000 ppm (50 mg/kg/day) based on decrease in pup

body weight gain during lactation.

84–2 Gene Mutation Assay (Ames Test) ................................. No appreciable increase in the reversion to histidine protrophy of 4 S.

typhimuriumstrains at 75 to 7500 μg/plate with & without S–9 activation.

84–2 Gene Mutation Assay Mammalian Cells ......................... Negative with and without metabolic activation up to 175 μg/ml.

84–2 Structural Chromosomal Aberration Assay In

vivocytogenetics.

The level of 650 mg/kg did not cause a significant increase in chromosomal aberrations in bone marrow cells sampled over the entire mitotic cycle.

84–2 Structural Chromosomal Aberration Assay In

vitrocytogenetics.

Did not induce chromosomal aberrations with & without metabolic activation

under the conditions of the study up to 200 μg/ml.

84–2 Structural Chromosomal Aberration Assay Dominant

Lethal Test.

Did not induce dominant lethal mutations under conditions of study at dose levels

up to 735 mg/kg.

84–2 Other Genotoxicity Assays (Unscheduled DNA Synthesis).Did not induce an increase in unscheduled DNA synthesis up to toxic dose. 0.1–

1000 μg/ml tested.

85–1 Metabolism ...................................................................... Rapidly absorbed and excreted. Completely eliminated by 96 hrs. Extensively

metabolized prior to excretion. Metabolic patterns similar for both sexes. Disposition & metabolism after pulse administration is linear over dose range.

85–1 Metabolism ...................................................................... Completely and rapidly absorbed. Extensively metabolized and rapidly and essentially completely excreted. Elimination of label from plasma biphasic and

evenly distribution between urine and feces. No tissue accumulation after 96

hours.

85–1 Metabolism ...................................................................... At least 7 major metabolites recovered and identified. Highest amounts of radioactivity found in liver, kidneys, large and small intestines. No tissue accumulation.

85–2 Dermal Absorption .......................................................... Although this study is considered unacceptable, the potential dermal absorption

is not expected to be greater than 50%.

B. Toxicological Endpoints

The dose at which the NOAEL from

the toxicology study identified as

appropriate for use in risk assessment is

used to estimate the toxicological

endpoint. However, the lowest dose at

which adverse effects of concern are

identified (the LOAEL) is sometimes

used for risk assessment if no NOAEL

was achieved in the toxicology study

selected. An uncertainty factor (UF) is

applied to reflect uncertainties inherent

in the extrapolation from laboratory

animal data to humans and in the

variations in sensitivity among members

of the human population as well as

other unknowns. An UF of 100 is

routinely used, 10X to account for

interspecies differences and 10X for

intra species differences.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD) where

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD=NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA Safety

Factor (FQPA SF).

For non-dietary risk assessments

(other than cancer) the UF is used to

determine the level of concern (LOC).

For example, when 100 is the

appropriate UF (10X to account for

interspecies differences and 10X for

intraspecies differences) the LOC is 100.

To estimate risk, a ratio of the NOAEL

to exposures (margin of exposure (MOE)

= NOAEL/exposure) is calculated and

compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q* is calculated and used to estimate

risk which represents a probability of

occurrence of additional cancer cases

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

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment. In this non-linear approach,

a ‘‘point of departure’’ is identified

below which carcinogenic effects are

not expected. The point of departure is

typically a NOAEL based on an

endpoint related to cancer effects

though it may be a different value

derived from the dose response curve.

To estimate risk, a ratio of the point of

departure to exposure (MOEcancer = point

of departure/exposures) is calculated.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Rules and Regulations 29967

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR MYCLOBUTANIL FOR UES IN HUMAN RISK

ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk

Assessment1 Study and Toxicological Effects

Acute Dietary females 13–50

years of age.

NOAEL = 60 mg/kg/day UF = 100

Acute RfD = 0.60 mg/kg/day ..........

FQPA SF = 1

aPAD = acute RfD ÷ FQPA SF =

[0.60] mg/kg/day.

Developmental Toxicity - rabbit

LOAEL = 200 mg/kg/day based on

increased resorptions, decreased

litter size and a decrease in the

viability index.

Acute Dietary general population including infants and

children.

none not applicable not applicable

Chronic Dietary all populations NOAEL = 2.49 mg/kg/day

UF = 100 .........................................

Chronic RfD = 0.025 mg/kg/day .....

FQPA SF = 1

cPAD = chronic RfD ÷ FQPA SF =

0.025 mg/kg/day.

Chronic Toxicity/Carcinogenicity -

rat

LOAEL = 9.94 mg/kg/day based on

decreased testicular weights and

increased testicular atrophy.

Short-Term Dermal (1 to 7

days) Residential.

dermal study NOAEL = 100 mg/kg/

day

LOC for MOE = 100 (Residential,

includes the FQPA SF)

28–day Dermal Toxicity-rat

LOAEL = > 100 mg/kg/day based

on no signs of toxicity at the high

dose of 100 mg/kg a.i.

Intermediate-Term Dermal (1

week to several months)

Residential.

oral study NOAEL= 10 mg/kg/day

(dermal absorption rate = 50%)

LOC for MOE = 100 (Residential,

includes the FQPA SF)

2 Generation Reproduction Toxicity

- rat

LOAEL = 50 mg/kg/day based on

atrophy of the testes and prostate as well as an increase in the

number of stillborn pups and a

decrease in pup weight gain during lactation.

Long-Term Dermal (several

months to lifetime) Residential.

oral study NOAEL= 2.49 mg/kg/day

(dermal absorption rate = 50%)

LOC for MOE = 100 (Residential,

includes the FQPA SF)

Chronic Toxicity/Carcinogenicity -

rat

LOAEL = 9.94 mg/kg/day based on

decreased testicular weights and

increased testicular atrophy.

Short-Term Inhalation (1 to 7

days) Residential.

oral study NOAEL= 10 mg/kg/day

(inhalation absorption rate =

100%)

LOC for MOE = 100 (Residential,

includes the FQPA SF)

2 Generation Reproduction Toxicity

- rat

LOAEL = 50 mg/kg/day based on

atrophy of the testes and prostate as well as an increase in the

number of stillborn pups and a

decrease in pup weight gain during lactation

Intermediate-Term Inhalation

(1 week to several months)

Residential.

oral study NOAEL= 10 mg/kg/day

(inhalation absorption rate =

100%)

LOC for MOE = 100 (Residential,

includes the FQPA SF)

2 Generation Reproduction Toxicity

- rabbit

LOAEL = 50 mg/kg/day based on

atrophy of the testes and prostate as well as an increase in the

number of stillborn pups and a

decrease in pup weight gain during lactation.

Long-Term Inhalation (several

months to lifetime) Residential.

oral study NOAEL= 2.49 mg/kg/day

(inhalation absorption rate =

100%)

LOC for MOE = 100 (Residential,

includes the FQPA SF)

chronic Toxicity/Carcinogenicity -

rat

LOAEL = 9.94 mg/kg/day based on

decreased testicular weights and

increased testicular atrophy.

Cancer (oral, dermal, inhalation).‘‘Group E’’ not applicable not applicable

1 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 180.443) for the

combined residues of myclobutanil, in

or on a variety of raw agricultural

commodities. Permanent tolerances are

established for the combined residues of

myclobutanil and its alcohol metabolite

(free and bound) in or on a variety of

commodities at levels ranging from 0.02

to 25.0 ppm and in meat, milk, poultry,

and eggs at levels ranging from 0.02 to

1.0 ppm. Risk assessments were

conducted by EPA to assess dietary

exposures from myclobutanil 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 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

29968 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Rules and Regulations

analysis was performed using tolerance

level residues and 100% crop treated

(CT) information for all registered and

proposed uses. The acute analysis was

performed for females (13–50 years old)

only (no acute endpoint was chosen for

the general U.S. population).

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: The chronic

analysis was performed using published

and proposed tolerance levels for all

commodities. For the chronic analysis,

percent CT information was used for

apples, apricots, cherries, grapes,

nectarines, peaches, pears, plums, and

cotton and 100% CT was assumed for

all other commodities.

iii.Cancer. A cancer dietary exposure

assessment was not performed since

myclobutanil was not carcinogenic in

two acceptable animal studies.

iv. Anticipated residue and percent

crop treated information. Section

408(b)(2)(F) states that the Agency may

use data on the actual percent of food

treated for assessing chronic dietary risk

only if the Agency can make the

following findings: Condition 1, that the

data used are reliable and provide a

valid basis to show what percentage of

the food derived from such crop is

likely to contain such pesticide residue;

Condition 2, that the exposure estimate

does not underestimate exposure for any

significant subpopulation group; and

Condition 3, if data are available on

pesticide use and food consumption in

a particular area, the exposure estimate

does not understate exposure for the

population in such area. In addition, the

Agency must provide for periodic

evaluation of any estimates used. To

provide for the periodic evaluation of

the estimate of percent crop treated

(PCT) as required by section

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

registrants to submit data on PCT.

The Agency used percent crop treated

(PCT) information as follows.

Crop

Percent

crop

treated

Apples ......................................... 40

Apricots ....................................... 15

Cherries ...................................... 40

Cotton ......................................... <1

Grapes ........................................ 45

Nectarines ................................... 20

Peaches ...................................... 10

Pears .......................................... < 1

Crop

Percent

crop

treated

Plums .......................................... 15

The Agency believes that the three

conditions listed above have been met.

With respect to Condition 1, PCT

estimates are derived from Federal and

private market survey data, which are

reliable and have a valid basis. EPA uses

a weighted average PCT for chronic

dietary exposure estimates. This

weighted average PCT figure is derived

by averaging State-level data for a

period of up to 10 years, and weighting

for the more robust and recent data. A

weighted average of the PCT reasonably

represents a person’s dietary exposure

over a lifetime, and is unlikely to

underestimate exposure to an individual

because pesticide use patterns (both

regionally and nationally) tend to

change continuously over time, such

that an individual is unlikely to be

exposed to more than the average PCT

over a lifetime. For acute dietary

exposure estimates, EPA uses an

estimated maximum PCT. The exposure

estimates resulting from this approach

reasonably represent the highest levels

to which an individual could be

exposed, and are unlikely to

underestimate an individual’s acute

dietary exposure. The Agency is

reasonably certain that the percentage of

the food treated is not likely to be an

underestimation. As to Conditions 2 and

3, regional consumption information

and consumption information for

significant subpopulations is taken into

account through EPA’s computer-based

model for evaluating the exposure of

significant subpopulations including

several regional groups. Use of this

consumption information in EPA’s risk

assessment process ensures that EPA’s

exposure estimate does not understate

exposure for any significant

subpopulation group and allows the

Agency to be reasonably certain that no

regional population is exposed to

residue levels higher than those

estimated by the Agency. Other than the

data available through national food

consumption surveys, EPA does not

have available information on the

regional consumption of food to which

myclobutanil may be applied in a

particular area.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive drinking water dietary

exposure analysis and risk assessment

for myclobutanil 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

myclobutanil.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and SCIGROW, which predicts pesticide

concentrations in groundwater. In

general, EPA will use GENEEC (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model) for a screening-level

assessment for surface water. The

GENEEC model is a subset of the PRZM/

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

GENEEC incorporates a farm pond

scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models include

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever exceed human health levels of

concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a %RfD or %PAD.

Instead, drinking water levels of

comparison (DWLOCs) are calculated

and used as a point of comparison

against the model estimates of a

pesticide’s concentration in water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food, and from

residential uses. Since DWLOCs address

total aggregate exposure to

myclobutanil, they are further discussed

in the aggregate risk sections below.

Based on the GENEEC and SCI-GROW

models, the estimated environmental

concentrations (EECs) of myclobutanil

for acute exposure are estimated to be

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Rules and Regulations 29969

115 parts per billion (ppb) in surface

water and 2 ppb for ground water. The

EECs for chronic exposures are

estimated to be 31 ppb for surface water

and 2 ppb for ground water.

3. From non-dietary exposure.

Myclobutanil is currently registered for

use on the following residential nondietary sites: homeowner use on turf,

roses, flowers, shrubs and trees. The

term ‘‘residential exposure’’ is used in

this document to refer to nonoccupation, nondietary exposure

resulting from pesticide uses in

residential settings (e.g., pesticide uses

for lawn and garden pest control, indoor

pest control, termiticides, and flea and

tick control on pets.) The risk

assessment was conducted using the

following exposure assumptions:

i. Residential handler exposure. Based

on the residential use-patterns

associated with myclobutanil, there is

potential for exposures to handlers of

myclobutanil. In order to present a highend scenario of residential exposure, it

was assumed that one person would

complete all mixing, loading and

application of myclobutanil. Exposure

scenarios were assessed, at the

maximum application rate, for mixing,

loading, and application of a soluble

concentrate product by trigger bottle

sprayer (treating ornamental plants),

and by hose-end sprayer (treating

turfgrass) to represent the worst-case

scenario for the proposed uses. There

are no chemical specific data available

to support the residential use scenarios

of myclobutanil. Therefore, modeling

(PHED v 1.1 surrogate table) was used

to represent the highest potential for

exposure from homeowner application

of myclobutanil.

ii. Residential post application

exposure. Potential residential

exposures are expected following

applications to lawns, ornamentals and

home garden sites. Chemical-specific

data are available to determine the

potential risks from post-application

activities. The registrant submitted a

dislodgeable foliar residue (DFR) study

on grapes for myclobutanil. Short-term

post-application exposure estimates

were done using the study determined

DFR of 0.175 μg/cm2 (on day 0). For

intermediate-term post-application

exposure, an average of DFRs from day

0 through day 14 was used. The postapplication risk assessment is based on

DFR data from the submitted study on

grapes and generic assumptions as

specified by the recently revised

Residential SOPs.

Based on the use pattern, exposure to

myclobutanil-treated ornamentals is

expected to be incidental and shortterm. Both short- and intermediate-term

exposures are expected following lawn

applications of myclobutanil. Shortterm aggregate post-application

exposure for the adult was done for

dermal exposure to treated turf and

ornamentals. Since there is no

intermediate-term exposure for the

residential handler, there is no aggregate

intermediate-term exposure for the

adult.

Short-term, non-dietary ingestion

exposure to toddlers is not assessed

since EPA did not detect an acute

dietary or oral endpoint applicable to

infants and children. Therefore, EPA

does not expect short-term non-dietary

exposure to pose a risk to infants and

children. The only short-term toddler

exposure that was considered consists

of dermal post-application exposure.

However, EPA determined that the

short-term dermal exposure should not

be aggregated with the short-term oral

exposure because the toxic effects are

different.

Additionally, intermediate-term, nondietary ingestion exposure for toddlers

is possible and was assessed using the

intermediate-term dose and endpoint

identified from the two generation

reproduction toxicity study in rats.

Intermediate-term aggregate exposure

for toddlers combines non-dietary

ingestion and dermal exposure from

treated turf.

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

myclobutanil 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,

myclobutanil 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 myclobutanil 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 based 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.

There was no evidence of increased

susceptibility in the developmental

toxicity studies with rats and rabbits.

The data from the 2-generation

reproduction study in rats provided no

indication of quantitative or qualitative

increased susceptibility since maternal

toxicity and reproductive toxicity

occurred at the same dose.

iii. Conclusion. There is a complete

toxicity data base for myclobutanil and

exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures. EPA

determined that the 10X safety factor to

protect infants and children should be

removed. The FQPA factor is removed

because:

a. There are no toxicity or residential

exposure data gaps in the consideration

of the FQPA Safety Factor.

b. There was no evidence of increased

susceptibility in the developmental

toxicity studies with rats and rabbits

and the 2-generation reproduction study

in rats provided no indication of

quantitative or qualitative increased

susceptibility since maternal toxicity

and reproductive toxicity occurred at

the same dose.

c. A developmental neurotoxicity

study is not required because neurotoxic

compounds of similar structure were

not identified and there was no

evidence of neurotoxicity in the current

toxicity database.

d. The exposure assessments will not

underestimate the potential dietary

(food and drinking water) and

residential (non-occupational)

exposures for infants and children from

the use of myclobutanil.

E. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

29970 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Rules and Regulations

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 + chronic non-dietary, nonoccupational exposure). This allowable

exposure through drinking water is used

to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking water

consumption, and body weights. Default

body weights and consumption values

as used by the USEPA Office of Water

are used to calculate DWLOCs: 2L/70 kg

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

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

weights and drinking water

consumption values vary on an

individual basis. This variation will be

taken into account in more refined

screening-level and quantitative

drinking water exposure assessments.

Different populations will have different

DWLOCs. Generally, a DWLOC is

calculated for each type of risk

assessment used: acute, short-term,

intermediate-term, chronic, and cancer.

When EECs for surface water and

groundwater are less than the calculated

DWLOCs, OPP concludes with

reasonable certainty that exposures to

myclobutanil 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 myclobutanil on drinking

water as a part of the aggregate risk

assessment process.

1. Acute risk. Using the exposure

assumptions discussed in this unit for

acute exposure, the acute dietary

exposure from food to myclobutanil will

occupy 2% of the aPAD for females 13

years and older at the 95th percentile of

exposure. In addition, despite the

potential for acute dietary exposure to

myclobutanil in drinking water, after

calculating DWLOCs and comparing

them to conservative model estimated

environmental concentrations of

myclobutanil in surface and ground

water (115 ppb and 2 ppb, respectively),

EPA does not expect the aggregate

exposure to exceed 100% of the aPAD.

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

Population Subgroup aPAD (mg/kg) %aPAD

(Food)

Surface Water

EEC (ppb)

Ground Water

EEC (ppb)

Acute DWLOC

(ppb)

Females (13 to 50 years) .................................................... 0. 60 2 115 2 18,000

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to myclobutanil from food

will utilize 17% of the cPAD for the

U.S. population, 48% of the cPAD for

infants < 1 year old and 52% of the

cPAD for children 1 to 6 years old.

There are no residential uses for

myclobutanil that result in chronic

residential exposure. In addition,

despite the potential for chronic dietary

exposure to myclobutanil in drinking

water, after calculating the DWLOCs

and comparing them to conservative

model estimated environmental

concentrations of myclobutanil in

surface and ground water, EPA does not

expect the aggregate exposure to exceed

100% of the cPAD.

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

Population Subgroup cPAD mg/kg/

day %cPAD (Food) Surface WaterEEC (ppb)

Ground Water

EEC (ppb)

Chronic

DWLOC (ppb)

U.S. Population .................................................................... 0.025 17 31 2 720

All Infants (<1 year old) ....................................................... 0.025 48 31 2 130

Children 1 to 6 years ........................................................... 0.025 52 31 2 120

Children 7 to 12 years ......................................................... 0.025 26 31 2 190

Females (13 to 50 years) .................................................... 0.025 11 31 2 670

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). EPA

has determined that oral and dermal

exposures can not be aggregated due to

differences in the toxicological

endpoints via the oral (developmental

study) and dermal routes. Therefore,

short-term aggregate risk is captured by

assessment of acute risk above.

4. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account non-dietary, nonoccupational exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Using the exposure assumptions

described in this unit for intermediateterm exposures, EPA has concluded that

food and residential exposures

aggregated result in aggregate MOEs of

650 for the U.S. population and 310 for

infants and children. These aggregate

MOEs do not exceed the Agency’s level

of concern (LOC = 100) for aggregate

exposure to food and residential uses. In

addition, DWLOCs were calculated to

account for the potential of

intermediate-term exposure to

myclobutanil in drinking water. After

calculating DWLOCs and comparing

them to conservative model estimated

environmental concentrations of

myclobutanil in surface and ground

water (31 ppb and 2 ppb, respectively),

EPA does not expect the intermediateterm aggregate exposure to exceed the

Agency’s level of concern.

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Rules and Regulations 29971

TABLE 5.—AGGREGATE RISK ASSESSMENT FOR INTERMEDIATE-TERM EXPOSURE TO MYCLOBUTANIL

Population Subgroup

Aggregate

MOE (Food +

Residential)

Aggregate

Level of Concern (LOC)

Surface Water

EEC (ppb)

Ground Water

EEC (ppb)

IntermediateTerm DWLOC

(ppb)

U.S. Population .................................................................... 605 100 31 2 3,000

Infants and Children ............................................................. 310 100 31 2 680

6. Aggregate cancer risk for U.S.

population. Myclobutanil is not

carcinogenic in either the rat or mouse

and, therefore, is not expected to pose

a cancer risk to humans.

7. 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 myclobutanil

residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

An adequate enforcement method

(Rohm and Haas Method 34S–88–10) is

available to enforce the proposed

tolerances. Quantitation is by gas liquid

chromatography using a nitrogen/

phosphorus detector for myclobutanil

and an electron capture detector (Ni63)

for residues measured as the alcohol

metabolite. The method may be

requested from: Calvin Furlow, PRRIB,

IRSD (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Ariel Rios Bldg., 1200

Pennsylvania Ave. NW, Washington, DC

20460; telephone number: (703) 305–

5229; e-mail address:

furlow.calvin@epa.gov.

B. International Residue Limits

A Codex maximum residue limit

(MRL) is presently established for

residues of myclobutanil per se in/on

pome fruit at 0.5 ppm. Canadian MRLs

have been established for residues of

(RS)-2-p-chlorophenyl-2-(1H-1,2,4-

triazol-1-ylmethyl)hexanenitrile,

including the free and conjugated forms

of its metabolites (RS)-2-pchlorophenyl-1-(1H-1,2,4-triazol-1-

ylmethyl)-5-hydroxy-hexanenitrile and

(RS)-2-p-chlorophenyl-2-(1H-1,2,4-

triazol-1ylmethyl)-5-keto-hexanenitrile

on apples and apple juice at 0.5 ppm.

No Mexican MRLs have been

established for the use on mayhaw.

Harmonization with Codex or the

Canadian MRLs is not possible as the

tolerance expressions for both differ

from the proposed U.S. tolerance.

C. Conditions

Rohm and Haas has requested

conditional registration for caneberry,

currant, gooseberry, mayhaw,

peppermint, spearmint, snap beans, and

tomato. Upon receipt and evaluation of

additional residue field trials for these

crops, the Agency will reassess the

registration and, if appropriate, will

issue unconditional registration for

these uses. In addition, the registration

on cucurbits, mint, snap beans,

strawberries and tomatoes will be

conditional pending the submission and

EPA review of a field rotational crop

study.

V. Conclusion

Therefore, tolerances are established

for combined residues of myclobutanil

in apple, wet pomace at 1.3 ppm;

asparagus at 0.02 ppm; the caneberry

subgroup at 2.0 ppm, the cucurbit

vegetable group at 0.20 ppm, currant at

3.0 ppm, gooseberry at 2.0 ppm,

mayhaw at 0.70 ppm; peppermint tops

at 3.0 ppm, succulent snap bean at 1.0

ppm; spearmint tops at 3.0 ppm,

strawberry at 0.50 ppm, tomato at 0.30

ppm; tomato, puree at 0.50 ppm;

tomato, paste at 1.0 ppm. In addition

tolerances for indirect and inadvertent

residues of myclobutanil per se at 0.03

ppm are established in root and tuber

vegetable group; leaves of root and tuber

vegetable group; leafy vegetable, except

Brassica, group; Brassica leafy vegetable

group; legume vegetable group; fruiting

vegetable group; cereal grains group;

forage, fodder, and straw of cereal grains

group; nongrass animal feed group; and

foliage of legume vegetable group.

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 300994 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 July 10, 2000.

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.

29972 Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Rules and Regulations

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, Ariel Rios Bldg.,

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, 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, Ariel Rios Bldg.,

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, Ariel Rios Bldg.,

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–300994, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, Ariel Rios Bldg.,

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 file

format 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 tolerances

under FFDCA section 408(d) in

response to petitions 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 tolerances 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

Federal Register / Vol. 65, No. 91 / Wednesday, May 10, 2000 / Rules and Regulations 29973

and pests, Reporting and recordkeeping

requirements.

Dated: April 28, 2000

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), (346a) and

371.

2. Section 180.443 is amended by

revising the introductory text of

paragraph (a), by adding alphabetically

new entries to the table in paragraph (a),

and by revising paragraph (d) the read

as follows:

§ 180.443 Myclobutanil; tolerances for

residues.

(a) General. Tolerances are

established for combined residues of the

fungicide myclobutanil alpha-butylalpha-(4-chlorophenyl)-1H-1,2,4-

triazole-1-propanenitrile and its alcohol

metabolite (alpha-(3-hydroxybutyl)-

alpha-(4-chlorophenyl)-1H-1,2,4-

triazole-1-propanenitrile (free and

bound), in or on the following food

commodities:

Commodity Parts per

million

*****

Apple, wet pomace ................... 1.3

*****

Asparagus ................................. 0.02

*****

Bean, snap, succulent .............. 1.0

Caneberry subgroup ................. 2.0

*****

Currant ...................................... 3.0

*****

Gooseberry ............................... 2.0

*****

Mayhaw .................................... 0.70

*****

Peppermint, tops ...................... 3.0

*****

Spearmint, tops ........................ 3.0

Strawberry ................................ 0.50

*****

Tomato ...................................... 0.30

Tomato, puree .......................... 0.50

Tomato, paste ........................... 1.0

Vegetable, cucurbit, group ....... 0.20

*****

(d)Indirect or inadvertent residues.

Tolerances are established for residues

of the fungicide myclobutanil alphabutyl-alpha-(4-chlorophenyl)-1H-1,2,4-

triazole-1-propanenitrile in or on the

following food commodities:

Commodity Parts per

million

Animal Feed, Nongrass, Group 0.03

Grains, Cereal, Forage, Fodder, and Straw, Group .......... 0.03

Grains, Cereal, Group .............. 0.03

Vegetable, Brassica, Leafy,

Group .................................... 0.03

Vegetable, Foliage of Legume,

Group .................................... 0.03

Vegetable, Fruiting, Group ....... 0.03

Vegetable, Leafy, Except Brassica, Group ............................ 0.03

Vegetable, Leaves of Root and

Tuber, Group ......................... 0.03

Vegetable, Legume, Group ...... 0.03

Vegetable, Root and Tuber,

Group .................................... 0.03

[FR Doc. 00–11571 Filed 5–9–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 271

[FRL–6600–4]

West Virginia: Final Authorization of

State Hazardous Waste Management

Program Revision

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Immediate final rule.

SUMMARY: West Virginia has applied to

EPA for Final authorization of the

revision to its hazardous waste program

under the Resource Conservation and

Recovery Act (RCRA). The revision

covers statutory and regulatory changes

to the State’s authorized hazardous

waste program, including the adoption

of the Federal hazardous regulations, as

amended through June 30, 1997, and the

Federal final rules published in the

Federal Register on December 8, 1997,

May 26, 1998, June 8, 1998, and on June

19, 1998 with certain exceptions

described in section H in the

Supplementary Information section of

this document. EPA has determined that

its hazardous waste program revisions

satisfy all of the requirements necessary

to qualify for Final authorization, and is

authorizing the state program revision

through this immediate final action.

EPA is publishing this rule without

prior proposal because the Agency

views this as a noncontroversial action

and does not anticipate adverse

comments. However, in the proposed

rules section of this Federal Register,

EPA is publishing a separate document

that will serve as a proposal to authorize

the revision should the Agency receive

adverse comment. If EPA receives

comments that oppose this action or

portion(s) thereof, we will publish a

document in the Federal Register

withdrawing this rule or portion(s)

thereof before it takes effect and a

separate document in the proposed

rules section of this Federal Register

will serve as a proposal to authorize the

changes. Unless EPA receives adverse

written comments during the review

and comment period, the decision to

authorize West Virginia’s hazardous

waste program revision will take effect

as provided below.

DATES: This Final authorization for West

Virginia will become effective without

further notice on July 10, 2000, unless

EPA receives adverse comments by June

9, 2000. Once again if EPA should

receive such comments on its decision,

the Agency will publish a timely

withdrawal informing the public that

this rule will not take effect.

ADDRESSES: Send written comments to

Sharon McCauley, Mailcode 3WC21,

RCRA State Programs Branch, U.S. EPA

Region III, 1650 Arch Street,

Philadelphia, PA 19103, Phone number:

(215) 814–3376. EPA must receive your

comments by June 9, 2000. Copies of the

West Virginia program revision

application and the materials which

EPA used in evaluating the revision are

available for inspection and copying

from 8 a.m. to 4:30 p.m., Monday

through Friday at the following

addresses: West Virginia Division of

Environmental Protection, Office of

Waste Management, 1356 Hansford

Street, Charleston, WV 25301–1401,

Phone number: 304–558–4253 and EPA

Region III, Library, 2nd Floor, 1650

Arch Street, Philadelphia, PA 19103,

Phone number: (215) 814–5254.

FOR FURTHER INFORMATION CONTACT:

Sharon McCauley, Mailcode 3WC21,

RCRA State Programs Branch, U.S. EPA

Region III, 1650 Arch Street,

Philadelphia, PA 19103, Phone number:

(215) 814–3376.

SUPPLEMENTARY INFORMATION:

A. Why Are Revisions to State

Programs Necessary?

RCRA, as amended by the Hazardous

and Solid Waste Amendments of 1984

(HSWA), provides for authorization of

State hazardous waste programs under

Subtitle C. Under RCRA section 3006,

EPA may authorize a State to administer

and enforce the RCRA hazardous waste