40632 Federal Register / Vol. 65, No. 127 / Friday, June 30, 2000 / Notices

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.

III. How Can I Respond to this Action?

A. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number OPP–34215A in the

subject line on the first page of your

response.

1. By mail. Submit comments 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.

2. In person or by courier. Deliver

comments to: Public Information and

Records Integrity Branch, Information

Resources and Services Division, Office

of Pesticide Programs, Environmental

Protection Agency, Rm. 119, Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA. The PIRIB is open from

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

Friday, excluding legal holidays. The

PIRIB telephone number is (703) 305–

5805.

3. Electronically. Submit electronic

comments by e-mail to: ‘‘oppdocket@epa.gov,’’ or you can submit a

computer disk as described in this unit.

Do not submit any information

electronically that you consider to be

CBI. Electronic comments must be

submitted as an ASCII file, avoiding the

use of special characters and any form

of encryption. Comments and data will

also be accepted on standard computer

disks in WordPerfect 6.1/8.0 or ASCII

file format. All comments in electronic

form must be identified by the docket

control number OPP–34215A.

Electronic comments may also be filed

online at many Federal Depository

Libraries.

B. How Should I Handle CBI

Information that I Want to Submit to the

Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI 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.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person listed under

‘‘FOR FURTHER INFORMATION

CONTACT.’’

IV. What Action is EPA Taking in this

Notice?

EPA is making available for public

viewing the revised risk assessments

and related documents for one

organophosphate pesticide, mevinphos.

These documents have been developed

as part of the pilot public participation

process that EPA and USDA are now

using for involving the public in the

reassessment of pesticide tolerances

under the Food Quality Protection Act

(FQPA), and the reregistration of

individual organophosphate pesticides

under the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA). The pilot public participation

process was developed as part of the

EPA-USDA Tolerance Reassessment

Advisory Committee (TRAC), which

was established in April 1998, as a

subcommittee under the auspices of

EPA’s National Advisory Council for

Environmental Policy and Technology.

A goal of the pilot public participation

process is to find a more effective way

for the public to participate at critical

junctures in the Agency’s development

of organophosphate risk assessments

and risk management decisions. EPA

and USDA began implementing this

pilot process in August 1998, to increase

transparency and opportunities for

stakeholder consultation. The

documents being released to the public

through this notice provide information

on the revisions that were made to the

mevinphos preliminary risk

assessments, which was released to the

public January 12, 2000 (65 FR 1869)

(FRL–6486–9) through a notice in the

Federal Register.

In addition, this notice starts a 60-day

public participation period during

which the public is encouraged to

submit risk management proposals or

otherwise comment on risk management

for mevinphos. The Agency is providing

an opportunity, through this notice, for

interested parties to provide written risk

management proposals or ideas to the

Agency on the chemical specified in

this notice. Such comments and

proposals could address ideas about

how to manage dietary, occupational, or

ecological risks on specific mevinphos

use sites or crops across the United

States or in a particular geographic

region of the country. To address dietary

risk, for example, commenters may

choose to discuss the feasibility of lower

application rates, increasing the time

interval between application and

harvest (‘‘pre-harvest intervals’’),

modifications in use, or suggest

alternative measures to reduce residues

contributing to dietary exposure. For

occupational risks, commenters may

suggest personal protective equipment

or technologies to reduce exposure to

workers and pesticide handlers. For

ecological risks, commentors may

suggest ways to reduce environmental

exposure, e.g., exposure to birds, fish,

mammals, and other non-target

organisms. EPA will provide other

opportunities for public participation

and comment on issues associated with

the organophosphate tolerance

reassessment program. Failure to

participate or comment as part of this

opportunity will in no way prejudice or

limit a commenter’s opportunity to

participate fully in later notice and

comment processes. All comments and

proposals must be received by EPA on

or before August 29, 2000 at the

addresses given under the

‘‘ADDRESSES’’ section. Comments and

proposals will become part of the

Agency record for the organophosphates

specified in this notice.

List of Subjects

Environmental protection, Chemicals,

Pesticides and pests.

Dated: June 21, 2000.

Lois Rossi,

Director, Special Review and Reregistration

Division, Office of Pesticide Programs.

[FR Doc. 00–16635 Filed 6–29–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–951; FRL–6592–6]

Notice of Filing Pesticide Petitions to

Establish a Tolerance for Certain

Pesticide Chemicals in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filings and amendments of

pesticide petitions proposing the

establishment/amendments of

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

Federal Register / Vol. 65, No. 127 / Friday, June 30, 2000 / Notices 40633

DATES: Comments, identified by docket

control number PF–951, must be

received on or before July 31, 2000.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I.C. of the ‘‘

SUPPLEMENTARY INFORMATION.’’

To ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–951 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 Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under ‘‘FOR FURTHER

INFORMATION CONTACT.’’

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’ 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 PF–

951. The official record consists of the

documents specifically referenced in

this action, any public comments

received during an applicable comment

period, 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 Highway,

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.

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–951 in the subject

line on the first page of your response.

1. By mail. Submit your comments to:

Public Information and Records

Integrity Branch (PIRIB), Information

Resources and Services Division

(7502C), Office of Pesticide Programs

(OPP), Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

2. In person or by courier. Deliver

your comments to: Public Information

and Records Integrity Branch (PIRIB),

Information Resources and Services

Division (7502C), Office of Pesticide

Programs (OPP), Environmental

Protection Agency, Rm. 119, Crystal

Mall #2, 1921 Jefferson Davis Highway,

Arlington, VA. The PIRIB is open from

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

Friday, excluding legal holidays. The

PIRIB telephone number is (703) 305–

5805.

3. Electronically. You may submit

your comments electronically by e-mail

to: ‘‘opp-docket@epa.gov ,’’ or you can

submit a computer disk as described

above. Do not submit any information

electronically that you consider to be

CBI. Avoid the use of special characters

and any form of encryption. Electronic

submissions will be accepted in

Wordperfect 6.1/8.0 or ASCII file

format. All comments in electronic form

must be identified by docket control

number PF–951. Electronic comments

may also be filed online at many Federal

Depository Libraries.

D. How Should I Handle CBI That I

Want to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI 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.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person identified

under ‘‘FOR FURTHER INFORMATION

CONTACT.’’

E. What Should I Consider as I Prepare

My Comments for EPA?

You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate that you provide.

5. Provide specific examples to

illustrate your concerns.

6. Make sure to submit your

comments by the deadline in this

notice.

7. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

name, date, and Federal Register

citation.

40634 Federal Register / Vol. 65, No. 127 / Friday, June 30, 2000 / Notices

II. What Action is the Agency Taking?

EPA has received pesticide petitions

as follows proposing the establishment

and/or amendment of regulations for

residues of certain pesticide chemicals

in or on various food commodities

under section 408 of the Federal Food,

Drug, and Comestic Act (FFDCA), 21

U.S.C. 346a. EPA has determined that

these petitions contain data or

information regarding the elements set

forth in section 408(d)(2); however, EPA

has not fully evaluated the sufficiency

of the submitted data at this time or

whether the data supports granting of

the petition. Additional data may be

needed before EPA rules on the petition.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: June 23, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summaries of Petitions

Petitioner summaries of the pesticide

petitions are printed below as required

by section 408(d)(3) of the FFDCA. The

summaries of the petitions were

prepared by the petitioners and

represent the views of the petitioners.

EPA is publishing the petition

summaries verbatim without editing

them in any way. The petition summary

announces the availability of a

description of the analytical methods

available to EPA for the detection and

measurement of the pesticide chemical

residues or an explanation of why no

such method is needed.

Initial Filings

1. Aventis CropScience USA LP

PP 0E6162

EPA has received a pesticide petition

0E6162 from Aventis CropScience, P.O.

Box 12014, 2 T.W. Alexander Drive,

Research Triangle Park, NC 27709,

proposing, pursuant to section 408(d) of

the Federal Food, Drug, and Cosmetic

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

amend 40 CFR part 180 by establishing

a tolerance for residues of ethyl 5,5-

diphenyl-2-isoxazoline-3-carboxylate

(CAS No. 163520–33–0) (herbicide

safener isoxadifen-ethyl, Company Code

AE F122006) in or on the raw

agricultural commodities corn grain at

0.1 parts per million (ppm), corn forage

at 0.3 ppm, and corn stover at 0.5 ppm.

EPA has determined that the petition

contains data or information regarding

the elements set forth in section

408(d)(2) of the FFDCA; however, EPA

has not fully evaluated the sufficiency

of the submitted data at this time or

whether the data support granting of the

petition. Additional data may be needed

before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of isoxadifen-ethyl (ethyl 5,5-diphenyl2-isoxazoline-3-carboxylate) in corn and

rice has been investigated and is

understood. Total residue levels in corn

commodities were very low. The initial

metabolic transformation of isoxadifenethyl in plants is hydrolysis of the

prominent ester function, yielding the

carboxylic acid, AE F129431 (4,5-

dihydro-5,5-diphenyl-3-

isoxazolecarboxylic acid), the principal

metabolite in forage, grain and stover.

The pathway then proceeds via

hydroxylation of the phenyl ring to AE

F162241 (4,5-dihydro-5-(4-

hydroxyphenyl)-5-phenyl-3-

isoxazolecarboxylic acid) which was

also significant in forage and stover. AE

F129431 and AE F162241 were also

identified in a rice metabolism and rat

metabolism study.

2. Analytical method. Based on the

results of the metabolism studies, the

analytical targets selected were the

parent compound, isoxadifen-ethyl, the

major metabolite AE F129431 and the

minor metabolite AE F162241. A

practical method for the determination

of these targets is available. Extractable

residues of isoxadifen-ethyl and its two

metabolites are extracted from crops

with blending in a mixture of acidic

aqueous acetonitrile. After washing with

hexane and treatment with saturated

brine, the analytes of interest are

partitioned into dichoromethane.

Isoxadifen-ethyl is separated from the

two acidic metabolites by selective solid

phase extraction, concentrated and

quantified by capillary gas

chromatography with ion-trap mass

spectrometric detection. The extract

containing the metabolites is divided in

two portions. One portion is treated

with trimethylsilyl-diazomethane to

convert AE F129431 to its methylated

derivative then quantified by capillary

gas chromatography with ion-trap mass

spectrometric detection. AE F162241 is

quantified in the second portion by high

performance liquid chromatography

with ion-trap mass spectrometric

detection. The limits of quantification

(LOQ) are 0.02 ppm in corn grain and

0.05 ppm in corn forage and stover.

3. Magnitude of residues. Residue

trials were carried out in a total of 29

field residue trials, in the U.S. and

Canada using a water dispersible

granule (WG) formulation containing

50% weight/weight (w/w) isoxadifenethyl. The preparation was

predominantly applied in a split

application of 30 grams/hectares (g/ha)

followed by 60 g/ha. In a limited

number of Canadian trials the

treatments were split as two sequential

applications of 45 grams active

ingredient/hectare (g ai/ha) each. In the

U.S. trials a single application of 160 g

ai/ha was also investigated. Pre-harvest

intervals were between 37 to 67, 60 to

121 and 79 to 151 days for forage, grain

and stover, respectively. No residues of

the parent compound were detected in

any corn grain stover or forage.

Isoxadifen-ethyl derived residues in

corn grain were limited to isolated

observations of the metabolite AE

F129431, to a maximum of 0.06 ppm.

Residues in corn stover and forage were

only observed in the form of AE

F129431 and AE F162241. Following

treatment of the corn with two

applications totaling 90 g ai/ha, residues

of AE F129431 and AE F162241 reached

respective maxima of 0.13 ppm and 0.08

ppm in stover but were not detected in

forage. Following treatment of the corn

with a single application of 160 g ai/ha,

residues of AE F129431 reached

respective maxima of 0.35 ppm and 0.15

ppm in stover and forage. Following the

higher application rate, residues of AE

F162241 reached respective maxima of

0.1 ppm and 0.05 ppm in stover and

forage. Tolerances are being proposed

for the parent compound and AE

F129431. Tolerances for the combined

residues of isoxadifen-ethyl and AE

F129431 are proposed at 0. 1 ppm, 0.3

ppm and 0.5 ppm respectively, for

grain, forage and stover. Tolerances are

not proposed for the more polar

metabolite, AE F162241 as it is not

found in corn grain. In animal feed

items levels are considerably lower than

AE F129431 and it does not accumulate

in animal tissues.

In a corn processing study, no

residues above 0.02 milligrams/

kilograms (mg/kg) were observed in

corn grain following treatment of the

crop at the nominal rate of 150 followed

by 300 g ai/ha. This exaggerated rate is

approximately five times the maximum

proposed label rate. Since no residues

were observed in the raw agricultural

commodity, neither analysis of the

processed commodities nor tolerances

are required. Although corn grain is fed

to cattle and poultry and cattle may be

grazed on forage or fed stover,

tolerances in meat, milk or eggs are not

necessary for a safener because

metabolism studies in cattle and poultry

indicated very low residue levels at

Federal Register / Vol. 65, No. 127 / Friday, June 30, 2000 / Notices 40635

dosing rates considerably higher than

anticipated from field ingestion.

B. Toxicological Profile

1. Acute toxicity. Isoxadifen-ethyl is

slightly toxic following acute oral

exposure, no more than slightly toxic

following acute dermal exposure and

practically non-toxic following acute

inhalation exposure. The acute rat oral

LD50 of isoxadifen-ethyl was 1,740 mg/

kg. The acute rat dermal LD50 was

greater than 2,000 mg/kg and the 4-hour

rat inhalation LC50 was > 5 milligrams/

liter (mg/L). Isoxadifen-ethyl was

slightly irritating to rabbit eyes and nonirritating to rabbit skin. Based on these

results, isoxadifen-ethyl would be

classified as EPA Category III for oral

and dermal toxicity and eye irritation,

and EPA Category IV for inhalation

toxicity and dermal irritation. Technical

isoxadifen-ethyl was shown to be a

dermal sensitizer in a guinea pig

maximization assay, but no evidence of

sensitization has been observed in a

Buehler assay when formulated into a

commercial product.

2. Genotoxicity. No evidence of

genotoxicity was noted in Salmonella

and E. coli reverse bacterial mutation

assays, an in vitro mammalian gene

mutation assay in Chinese hamster lung

(V79) cells, an in vivo unscheduled

DNA synthesis assay in rat hepatocytes,

or a mouse micronucleus assay. An

increase in chromosomal aberrations

was observed in an in vitro assay in

Chinese hamster lung (V79) cells, but

only at toxic concentrations. Thus, the

overall weight of evidence indicates that

isoxadifen-ethyl does not possess

significant genotoxic activity.

3. Reproductive and developmental

toxicity. A rat developmental toxicity

study was conducted at dose levels of 0,

15, 120, and 1,000 mg/kg/day. Maternal

toxicity (including one death) was noted

at 1,000 mg/kg/day. Slight

developmental toxicity (an increase in

resorptions) but no evidence of

teratogenicity was also noted at this

level. No effects were noted at 120 mg/

kg/day, which was considered to be the

no observed adverse effect level

(NOAEL) for both maternal and

developmental toxicity.

A rabbit developmental toxicity study

was conducted at dose levels of 0, 5, 50,

and 500 mg/kg/day. Maternal effects at

500 mg/kg/day consisted of decreased

food consumption, slight weight loss

during gestation days 6-8, and one

death. In addition, one animal at 500

mg/kg/day had only two empty

implantation sites. No evidence of

teratogenicity or developmental toxicity

was noted. Thus, 50 mg/kg/day was

considered to be the NOAEL for

maternal toxicity while 500 mg/kg/day

was the NOAEL for developmental

effects.

In the 2-generation reproduction

study in the rat, administration of

isoxadifen-ethyl at 4,000 ppm, resulted

in parental toxicity in both sexes from

the F0 and F1 generation consisting of

reduction in body weight gain food

intake and an increase in microscopic

kidney lesions. The only effect seen in

the offspring was lower pup weights of

the F1 generation together with a delay

in achievement of vaginal patency and

balanopreputial separation (due to the

reduced body weight), at 4,000 ppm.

The weights of F0 males were

significantly reduced throughout the

pre-mating treatment period; those of F2

females were reduced only during the

first week after weaning. The NOAEL

for both parental and neonatal toxicity

was 200 ppm, equivalent to an overall

mean achieved intake of about 16.4 mg/

kg body weight/day.

4. Subchronic toxicity. In a 90-day rat

feeding study, isoxadifen-ethyl was

administered at dietary concentrations

of 0, 20, 200, 2,000, and 4,000 ppm. The

NOAEL for this study was considered to

be 200 ppm (approximately 15.3 mg/kg/

day) based on decreased weight gain at

2,000 ppm, and decreased weight gain,

increased liver weights, and

centrilobular hepatocyte enlargement at

4,000 ppm.

In a 90-day feeding study in mice,

isoxadifen-ethyl was administered at

dietary concentrations of 13, 125, 1,250,

and 2,500 ppm. Decreased kidney

weights, increased liver weights, and

histopathological changes in the liver

(centrilobular hepatocyte enlargement

and vacuolation) were noted at 1,250

and 2,500 ppm. The NOAEL for this

study was 125 ppm (approximately 23

mg/kg/day).

In a 90-day dog feeding study,

isoxadifen-ethyl was administered to

beagle dogs at dietary concentrations of

0, 25, 125, and 1,000 ppm. Dietary

administration of 1,000 ppm isoxadifenethyl exceeded the maximum tolerated

dose (MTD), and it was concluded that

700 ppm would be a suitable high dose

level for a chronic dog study. The

NOAEL for this 90-day study was

considered to be 25 ppm (approximately

1.3 mg/kg/day) based on slight

histopathological effects in the kidneys

at 125 ppm, and effects on the kidneys,

spleen, liver, heart, and intestines at

1,000 ppm.

5. Chronic toxicity. Chronic toxicity

has been assessed in both the rat and the

dog. In the rat combined chronic

toxicity and oncogenicity study, the

liver was the target organ as evidenced

by increases in liver weight and

centrilobular hepatocyte hypertrophy.

The no-effect level was 200 ppm (10

mg/kg/day). Whilst in the dog the

kidney was the target organ with

vacuolation of the straight tubular

cytoplasm occurring at the high dose

level. The no-effect level was 3.5 mg/kg/

day indicating, as in the subchronic

studies, that the dog is the most

sensitive species. Based on the dog,

Aventis CropScience believes the

Reference Dose (RfD) for isoxadifenethyl is 0.035 mg/kg/day. No

carcinogenic activity was detected in

dogs, mice, and rats at the Maximum

Tolerated Dose (MTD). Isoxadifen-ethyl

is not oncogenic in dogs, rats, or mice

and is not likely to be carcinogenic in

humans. Aventis CropScience believes

isoxadifen-ethyl should be classified as

a ‘‘Not Likely’’ carcinogen based on the

lack of carcinogenicity in rats and mice.

6. Animal metabolism. The

metabolism of isoxadifen-ethyl has been

determined in the rat and dog. In both

species the main metabolic route was

hydrolysis of the ester to yield the free

acid AE F129431 (5,5-diphenyl-2-

isoxazoline-3-carboxylic acid), which is

the same as observed in plants. This was

the only significant metabolic route in

the dog following either gavage or

dietary dosing. In the rat there was an

additional metabolic route which led to

the formation of a hydroxylated free

acid, AE F162241 (4,5-dihydro-5-(4-

hydroxyphenyl)-5-phenyl-3-

isoxazolecarboxylic acid), also a plant

metabolite. This was a major metabolic

route in male rats, particular at the lowdose, but was only a minor metabolic

route in female rats. Unchanged

isoxadifen-ethyl was only excreted in

trace amounts in the feces. There were

a number of minor (< 3%) polar

metabolites also excreted, which were

not identified. A further plant

metabolite AE C637375 (b-hydroxy-bbenzenepropanenitrile) was also shown

to be a trace metabolite in the rat.

The metabolism of isoxadifen-ethyl in

ruminants is adequately understood. A

dairy cow was dosed with the

compound at a level equivalent to 11.52

ppm in the diet for 7 days. Total residue

levels were very low. Parent compound

was seen in fats and milk only. The

carboxylic acid, AE F129431, was the

major metabolite identified in all of the

tissues, with traces also being found in

the milk.

The metabolism of isoxadifen-ethyl in

poultry is also adequately understood.

Laying hens were fed the compound at

a level equivalent to 11 ppm in the diet

for 14 days. Residue levels were low in

all commodities. The vast majority of

the dose was excreted as AE F129431,

with smaller amounts of AE F162241

40636 Federal Register / Vol. 65, No. 127 / Friday, June 30, 2000 / Notices

and isoxadifen-ethyl. AE F129431 was

the major metabolite identified in all of

the tissues and yolks. Trace amounts of

isoxadifen-ethyl and AE F162241 were

detected in liver and eggs with

isoxadifen-ethyl also being detected in

the muscle. The metabolic profile of

isoxadifen-ethyl in the hen was similar

to that seen in the cow and rat.

7. Endocrine disruption. No special

studies have been conducted to

investigate the potential of isoxadifenethyl to induce estrogenic or other

endocrine effects. However, no evidence

of estrogenic or other endocrine effects

have been noted in any of the standard

toxicology studies that have been

conducted with this product and there

is no reason to suspect that any such

effects would be likely.

C. Aggregate Exposure

1. Dietary exposure. Isoxadifen-ethyl

will be used only as a herbicide safener

for use on rice and corn. No nonagricultural uses are anticipated. Thus,

the only potential sources of nonoccupational exposure to isoxadifenethyl would consist of any potential

residues in food and drinking water. As

previously indicated, in the absence of

any acute toxicity concerns, only

chronic exposures have been evaluated.

i. Food. Chronic dietary analysis was

conducted to estimate exposure to

potential isoxadifen-ethyl derived

residues in/on corn. A Tier One analysis

was conducted using the Dietary

Expected Evaluation Model (DEEM)

software and the 1994-1996 CSFII food

consumption data. It was assumed that

residues were at proposed tolerance

levels in rice (0.05 ppm) and corn grain

(0.1 ppm) and that 100% of crop was

treated. Additionally, based on the

results from appropriate studies, it was

assumed that there was no

concentration into processed

commodities and that contributions

from residues in meat, milk or eggs are

not required. A chronic RfD of 0.035

mg/kg/day is derived from the NOAEL

of 3.5 mg/kg/day in the most sensitive

species, dog. Using these inputs the

chronic dietary exposure estimate from

residues of isoxadifen-ethyl for the U.S.

population was 0.000173 mg/kg /day or

0.5% of its RfD. For the sub-population

with the highest exposure, non-nursing

infants, the chronic dietary exposure

estimate from residues of isoxadifenethyl was 0.000448 mg/kg/day, or 1.3%

of its RfD. These values are highly

conservative, having been based on

worst case assumptions of tolerance

level residues and 100% of the crop

treated.

ii. Drinking water. EPA’s Standard

Operating Procedure (SOP) for Drinking

Water Exposure and Risk Assessments

was used to perform the drinking water

assessment. This SOP uses a variety of

tools to conduct drinking water

assessment. These tools include water

models such as Screening Concentration

in Ground Water (SCI-GROW), Generic

Expected Environmental Concentration

(GENEEC), Pesticide Root Zone Model

(PRZMS)/EXAMS, and monitoring data.

If monitoring data are not available then

the models are used to predict potential

residues in surface and ground water

and the highest is assumed to be the

drinking water residue. In the case of

isoxadifen-ethyl monitoring data do not

exist; therefore, model calculations were

used to estimate a water residue. The

calculated drinking water levels of

comparison (DWLOC) for chronic

exposures for all adults and children

greatly exceed the drinking water

estimated concentrations (DWEC) from

the models. The chronic DWLOC for

adults is 1,218 parts per billion (ppb).

The chronic DWLOC for children/

toddlers is 346 ppb. The worst case

chronic DWEC is 0.165 ppb based on a

PRZM/EXAMS simulation of runoff into

surface water in a standard EPA

exposure assessment scenario for corn

(MLRA 111, Ohio). The DWEC

represents combined residues of

isoxadifen-ethyl and AE F129431,

expressed as isoxadifen-ethyl

equivalents.

2. Non-dietary exposure. Exposure to

isoxadifen-ethyl for the mixer/loader/

ground boom/aerial applicator was

calculated using the Pesticide Handlers

Exposure Database (PHED). It was

assumed that the product would be

applied to a maximum of 50 ha per day

(125 acres/day) by ground boom

applicator and 140 ha per day (350

acres/day) by aerial applicator at a

maximum use rate of 45 g a.i./ha.

Normal work attire consisting of longsleeved shirt, long pants, and protective

gloves was assumed in the PHED

assessment. Margins of exposure

(MOEs) for a 70 kg operator were

calculated utilizing a dermal NOAEL of

1,000 mg/kg body weight/day from the

rat dermal toxicity study and an

inhalation NOAEL of 3.5 mg/kg body

weight/day based on the dog chronic

toxicity study. The combined MOE

(inhalation plus dermal) for isoxadifenethyl was 28,000 for a ground operator

undertaking mixing, loading and

spraying. For aerial application where

the mixer/loader was assumed to be a

different operator from the pilot

combined MOEs were 17,000 for the

mixer/loader and 233,000 for the pilot.

The results indicate that large margins

of safety exist for the proposed use of

isoxadifen-ethyl.

D. Cumulative Effects

There is no information to indicate

that isoxadifen-ethyl may share a

common mechanism of toxicity with

any other chemical. Thus, this

assessment was not needed.

E. Safety Determination

1. U.S. population. Using the

conservative assumptions described

above, based on the completeness and

reliability of the toxicity data, it is

concluded that aggregate exposure, in

this case food only, to the proposed uses

of AE F 122006 will utilize at most 0.5%

of the reference dose for the U.S.

population. The actual exposure is

likely to be much less as more realistic

data and models are developed. EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risk to human

health. Drinking water levels of

comparison based on the dietary

exposure are much greater than highly

conservative estimated levels, and

would be expected to be well below the

100% level of the RfD, if they occur at

all. Therefore, there is a reasonable

certainty that no harm will occur to the

U.S. population from aggregate exposure

(food and drinking water) to isoxadifenethyl.

2. Infants and children. No evidence

of increased sensitivity to fetuses was

noted in There has been no indication

of reproductive effects or indication of

increased sensitivity to the offspring in

the 2-generation rat reproduction study.

No additional safety factor to protect

infants and children is necessary as

there is no evidence of increased

sensitivity in infants and children.

Using the conservative assumptions

described in the exposure section above,

the percent of the RfD that will be used

for exposure to residues of isoxadifenethyl in food for non-nursing infants

(the most highly exposed subgroup) is

1.3%. The children (1-6) exposure is

1.1% of the RfD. As in the adult

situation, DWLOCs are much higher

than the worst case DWECs and are

expected to use well below 100% of the

RfD, if they occur at all. Therefore, there

is a reasonable certainty that no harm

will occur to infants and children from

aggregate exposure to residues of AE

F122006.

F. International Tolerances

There are no Codex Alimentarius

Commission maximum residue levels

Federal Register / Vol. 65, No. 127 / Friday, June 30, 2000 / Notices 40637

established for residues of isoxadifenethyl.

2. Cabot Corporation

PP 0E6109

EPA has received a pesticide petition

(0E6109) from Cabot Corporation, 75

State St., Boston, MA, 02109 proposing,

pursuant to section 408(d) of the

FFDCA, 21 U.S.C. 346a(d), to amend 40

CFR part 180 to establish an exemption

from the requirement of a tolerance for

silicon dioxide, fumed, amorphous

when used in accordance with good

agricultural practices as an inert

ingredient in pesticide formulations

applied to animals. Silicon dioxide,

fumed, amorphous is already exempted

from the requirements of a tolerance

when used as an inert ingredient in

pesticide formulations applied to

growing crops or to raw agricultural

commodities after harvest. EPA has

determined that the petition contains

data or information regarding the

elements set forth in section 408(d)(2) of

the FFDCA; however, EPA has not fully

evaluated the sufficiency of the

submitted data at this time or whether

the data support granting of the petition.

Additional data may be needed before

EPA rules on the petition.

A. Residue Chemistry

No residue chemistry data are

presented in the petition as the Agency

does not generally require these data to

rule on the exemption from the

requirement of a tolerance for an inert

ingredient.

B. Toxicological Profile

The Agency has established a set of

criteria which identifies categories of

polymers that present low risk. These

criteria (described in 40 CFR 723.250)

identify polymers that are relatively

unreactive and stable compounds

compared to other chemical substances

as well as polymers that typically are

not readily absorbed. These properties

generally limit polymer’s ability to

cause adverse effects. The Agency

believes that polymers meeting the

criteria noted above will present

minimal or no risk. Cabot Corporation

believes that silicon dioxide, fumed,

amorphous conforms to the definition of

a polymer given in 40 CFR 723.250(b)

and meet the following criteria used to

identify a low risk polymer.

1. Silicon dioxide, fumed, amorphous

is not a cationic polymer, nor is it

reasonably anticipated to become a

cationic polymer in a natural aquatic

environment.

2. Silicon dioxide, fumed, amorphous

contains as an integral part of its

composition the atomic elements silicon

and oxygen.

3. Silicon dioxide, fumed, amorphous

does not contain as an integral part of

its composition, except as impurities,

any element other than those listed in

40 CFR 723.250(d)(2)(iii).

4. Silicon dioxide, fumed, amorphous

is not designed, nor is it reasonably

anticipated to substantially degrade,

decompose or depolymerize prior to,

during, or after use.

5. Silicon dioxide, fumed, amorphous

is not manufactured or imported from

monomers and/or reactants that are not

included on the Toxic Substances and

Control Act (TSCA) substance inventory

or manufactured under an applicable

TSCA section 5 exemption.

6. Silicon dioxide, fumed, amorphous

is not a water absorbing polymer with

a number average molecular weight

greater than or equal to 10,000.

7. Silicon dioxide, fumed, amorphous

has a minimum-average molecular

weight of 645,000 daltons. Substances

with molecular weights greater than 400

generally are not absorbed through the

intact skin, and substances with

molecular weights greater than 1,000

generally are not absorbed through the

gastrointestinal (GI) tract. Chemicals not

absorbed though the skin or GI tract

generally are incapable of eliciting a

toxic response.

8. Silicon dioxide, fumed, amorphous

has a minimum average molecular

weight of 645,000 daltons. Silicon

dioxide meets the requirements for

molecular weight distribution of

oligomer contents of less than 5% with

molecular weights less than 1,000 and

less than 2% with molecular weights

less than 500.

Cabot Corporation believes that

sufficient information has been

submitted to assess the hazards of

silicon dioxide, fumed, amorphous. No

toxicology data are being submitted as

the Agency does not generally require

these data to rule on the exemption from

the requirement of a tolerance for an

inert ingredient. Because silicon dioxide

conforms with the definition of a

polymer and meets the criteria of a

polymer under 40 CFR 723.250, Cabot

Corporation believes there are no

concerns for risks associated with

toxicity.

C. Aggregate Exposure

1. Dietary exposure. Silicon dioxide,

fumed, amorphous is not absorbed

through the intact gastrointestinal tract

and is incapable of eliciting a toxic

response.

2. Drinking water. Silicon dioxide,

fumed, amorphous is not soluble in

water and therefore there is no reason to

expect human exposure to residues in

water.

3. Non-dietary exposure. For most

uses of silicon dioxide, fumed,

amorphous the primary route of

exposure is dermal. Silicon dioxide,

fumed, amorphous with a molecular

weight significantly greater than 400 is

not absorbed through the intact skin.

D. Cumulative Effects

Cabot Corporation believes that

sufficient information has been

submitted to assess the hazards of

silicon dioxide, fumed, amorphous.

Because silicon dioxide, fumed,

amorphous conforms with the definition

of a polymer and meets the criteria of

a polymer under 40 CFR 723.250, Cabot

Corporation believes there are no

concerns for risks associated with

cumulative effects.

E. Safety Determination

1. U.S. population. Cabot Corporation

believes that sufficient information has

been submitted to assess the hazards of

silicon dioxide, fumed, amorphous.

Because silicon dioxide, fumed,

amorphous conforms with the definition

of a polymer and meets the criteria of

a polymer under 40 CFR 723.250, Cabot

Corporation believes there are no

concerns for risks associated with any

potential exposure to adults.

2. Infants and children. Cabot

Corporation believes that sufficient

information has been submitted to

assess the hazards of silicon dioxide,

fumed, amorphous. Because silicon

dioxide, fumed, amorphous conforms

with the definition of a polymer and

meets the criteria of a polymer under 40

CFR 723.250, Cabot Corporation

believes there are no concerns for risks

associated with exposure to infants and

children.

Amended Petitions

1. Cabot Corporation

9E6017

EPA has received an amendment to a

pesticide petition (9E6017) from Cabot

Corporation, 75 State St., Boston, MA,

02109 proposing, pursuant to section

408(d) of the FFDCA, 21 U.S.C. 346a(d),

to amend 40 CFR part 180 to amend an

exemption from the requirement of a

tolerance for dimethyl silicone polymer

with silica (TS-720) when used in

accordance with good agricultural

practices as an inert ingredient in

pesticide formulations applied to

growing crops in or on the raw

agricultural commodity after harvest or

to animals. The initial notice of filing

was published in the Federal Register of

August 25, 1999 (64 FR 46378) (FRL–

40638 Federal Register / Vol. 65, No. 127 / Friday, June 30, 2000 / Notices

6096–1). EPA has determined that the

petition contains data or information

regarding the elements set forth in

section 408(d)(2) of the FFDCA;

however, EPA has not fully evaluated

the sufficiency of the submitted data at

this time or whether the data support

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

An exemption from the requirement

of a tolerance under 40 CFR 180.1001(c)

and (e) was established for dimethyl

silicone polymer with silica in the

Federal Register on March 1, 2000 (65

FR 10946) (FRL–6490–9), with the

following uses: ‘‘moisture barrier, anticaking agent, anti-settling agent.’’ This

amendment to the petition requests that

the use ‘‘thickening agent’’ be added so

that the uses for dimethyl silicone

polymer with silica under 40 CFR

180.1001(c) and (e) will read as follows:

‘‘moisture barrier, anti-caking agent,

anti-settling agent, thickening agent.’’

A. Residue Chemistry

No residue chemistry data are

presented in the petition as the Agency

does not generally require these data to

rule on the exemption from the

requirement of a tolerance for an inert

ingredient.

B. Toxicological Profile

As discussed in the March 1, 2000

Federal Register, dimethyl silicone

polymer with silica meets all the criteria

for a low risk polymer, as specified in

40 CFR 723.250.

C. Aggregate Exposure

1. Dietary exposure. Dimethyl silicone

polymer with silica is not absorbed

through the intact gastrointestinal tract

and is incapable of eliciting a toxic

response.

2. Drinking water. Dimethyl silicone

polymer with silica is not soluble in

water and therefore there is no reason to

expect human exposure to residues in

water.

3. Non-dietary exposure. For most

uses of dimethyl silicone polymer with

silica, the primary route of exposure is

dermal. Dimethyl silicone polymer with

silica with a molecular weight

significantly greater than 400 is not

absorbed through the intact skin.

D. Cumulative Effects

Cabot Corporation believes that

sufficient information has been

submitted to assess the hazards of

dimethyl silicone polymer with silica.

Because dimethyl silicone polymer with

silica conforms with the definition of a

polymer and meets the criteria of a

polymer under 40 CFR 723.250, Cabot

Corporation believes there are no

concerns for risks associated with

cumulative effects.

E. Safety Determination

1. U.S. population. Cabot Corporation

believes that sufficient information has

been submitted to assess the hazards of

TS-720. Because TS-720 conforms with

the definition of a polymer and meets

the criteria of a polymer under 40 CFR

723.250, Cabot Corporation believes

there are no concerns for risks

associated with any potential exposure

to adults.

2. Infants and children. Cabot

Corporation believes that sufficient

information has been submitted to

assess the hazards of dimethyl silicone

polymer with silica. Because dimethyl

silicone polymer with silica conforms

with the definition of a polymer and

meets the criteria of a polymer under 40

CFR 723.250, Cabot Corporation

believes there are no concerns for risks

associated with exposure to infants and

children.

2. Cabot Corporation

9E6018

EPA has received an amendment to a

pesticide petition (9E6018) from Cabot

Corporation, proposing, pursuant to

section 408(d) of the FFDCA, 21 U.S.C.

346a(d), to amend 40 CFR part 180 to

amend an exemption from the

requirement of a tolerance for silane,

dichloromethyl-, reaction product with

silica (TS-610) when used in accordance

with good agricultural practices as an

inert ingredient in pesticide

formulations applied to growing crops

in or on the raw agricultural commodity

after harvest or to animals. The initial

notice of filing was published in the

Federal Register of August 25, 1999 (64

FR 46378) (FRL–6096–1). EPA has

determined that the petition contains

data or information regarding the

elements set forth in section 408(d)(2) of

the FFDCA; however, EPA has not fully

evaluated the sufficiency of the

submitted data at this time or whether

the data support granting of the petition.

Additional data may be needed before

EPA rules on the petition.

An exemption from the requirement

of a tolerance under 40 CFR 180.1001(c)

and (e) was established for silane,

dichloromethyl-, reaction product with

silica in the Federal Register of March

1, 2000 (65 FR 10946) (FRL–6490–9),

with the following uses: ‘‘moisture

barrier, anti-caking agent, anti-settling

agent, anti-thickening agent.’’ This

petition amendment requests that ‘‘antithickening’’ be revised by deleting

‘‘anti,’’ so that the uses for silane,

dichloromethyl-, reaction product with

silica under 40 CFR 180.1001(c) and (e)

will read as follows: ‘‘moisture barrier,

anti-caking agent, anti-settling agent,

thickening agent.’’

A. Residue Chemistry

No residue chemistry data are

presented in the petition as the Agency

does not generally require these data to

rule on the exemption from the

requirement of a tolerance for an inert

ingredient.

B. Toxicological Profile

As discussed in the March 1, 2000

Federal Register, silane,

dichloromethyl-, reaction product with

silica meets all the criteria for a low risk

polymer, as specified in 40 CFR

723.250.

C. Aggregate Exposure

1. Dietary exposure. Silane,

dichloromethyl-, reaction product with

silica is not absorbed through the intact

gastrointestinal tract and is incapable of

eliciting a toxic response.

2. Drinking water. Silane,

dichloromethyl-, reaction product with

silica is not soluble in water and

therefore there is no reason to expect

human exposure to residues in water.

3. Non-dietary exposure. For most

uses of silane, dichloromethyl-, reaction

product with silica the primary route of

exposure is dermal. Silane,

dichloromethyl-, reaction product with

silica, with a molecular weight

significantly greater than 400, is not

absorbed through the intact skin.

D. Cumulative Effects

Cabot Corporation believes that

sufficient information has been

submitted to assess the hazards of

silane, dichloromethyl-, reaction

product with silica. Because silane,

dichloromethyl-, reaction product with

silica conforms with the definition of a

polymer and meets the criteria of a

polymer under 40 CFR 723.250, Cabot

Corporation believes there are no

concerns for risks associated with

cumulative effects.

E. Safety Determination

1. U.S. population. Cabot Corporation

believes that sufficient information has

been submitted to assess the hazards of

silane, dichloromethyl-, reaction

product with silica. Because silane,

dichloromethyl-, reaction product with

silica conforms with the definition of a

polymer and meets the criteria of a

polymer under 40 CFR 723.250, Cabot

Corporation believes there are no

concerns for risks associated with any

potential exposure to adults.

Federal Register / Vol. 65, No. 127 / Friday, June 30, 2000 / Notices 40639

2. Infants and children. Cabot

Corporation believes that sufficient

information has been submitted to

assess the hazards of TS-610. Because

silane, dichloromethyl-, reaction

product with silica conforms with the

definition of a polymer and meets the

criteria of a polymer under 40 CFR

723.250, Cabot Corporation believes

there are no concerns for risks

associated with exposure to infants and

children.

3. Cabot Corporation

9E6019

EPA has received an amendment to a

pesticide petition (9E6019) from Cabot

Corporation proposing, pursuant to

section 408(d) of the FFDCA, 21 U.S.C.

346a(d), to amend 40 CFR part 180 to

amend an exemption from the

requirement of a tolerance for

hexamethyldisilizane, reaction product

with silica (TS-530) when used in

accordance with good agricultural

practices as an inert ingredient in

pesticide formulations applied to

growing crops in or on the raw

agricultural commodity after harvest or

to animals. The initial notice of filing

was published in the Federal Register of

August 25, 1999 (64 FR 46378) (FRL–

6096–1). EPA has determined that the

petition contains data or information

regarding the elements set forth in

section 408(d)(2) of the FFDCA;

however, EPA has not fully evaluated

the sufficiency of the submitted data at

this time or whether the data support

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

An exemption from the requirement

of a tolerance under 40 CFR 180.1001(c)

and (e) was established for

hexamethyldisilizane, reaction product

with silica in the Federal Register of

March 1, 2000 (65 FR 10946) (FRL–

6490–9), with the following uses:

‘‘moisture barrier, anti-caking agent,

anti-settling agent.’’ This petition

amendment requests that the use

‘‘thickening agent’’ be added so that the

uses for TS-530 under 40 CFR

180.1001(c) and (e) will read as follows:

‘‘moisture barrier, anti-caking agent,

anti-settling agent, thickening agent.’’

A. Residue Chemistry

No residue chemistry data are

presented in the petition as the Agency

does not generally require these data to

rule on the exemption from the

requirement of a tolerance for an inert

ingredient.

B. Toxicological Profile

As discussed in the March 1, 2000

Federal Register, hexamethyldisilizane,

reaction product with silica meets all

the criteria for a low risk polymer, as

specified in 40 CFR 723.250.

C. Aggregate Exposure

1. Dietary exposure.

Hexamethyldisilizane, reaction product

with silica is not absorbed through the

intact gastrointestinal tract and is

incapable of eliciting a toxic response.

2. Drinking water.

Hexamethyldisilizane, reaction product

with silica is not soluble in water and

therefore there is no reason to expect

human exposure to residues in water.

3. Non-dietary exposure. For most

uses of hexamethyldisilizane, reaction

product with silica the primary route of

exposure is dermal.

Hexamethyldisilizane, reaction product

with silica with a molecular weight

significantly greater than 400 is not

absorbed through the intact skin.

D. Cumulative Effects

Cabot Corporation believes that

sufficient information has been

submitted to assess the hazards of

hexamethyldisilizane, reaction product

with silica. Because

hexamethyldisilizane, reaction product

with silica conforms with the definition

of a polymer and meets the criteria of

a polymer under 40 CFR 723.250, Cabot

Corporation believes there are no

concerns for risks associated with

cumulative effects.

E. Safety Determination

1. U.S. population. Cabot Corporation

believes that sufficient information has

been submitted to assess the hazards of

hexamethyldisilizane, reaction product

with silica. Because

hexamethyldisilizane, reaction product

with silica conforms with the definition

of a polymer and meets the criteria of

a polymer under 40 CFR 723.250, Cabot

Corporation believes there are no

concerns for risks associated with any

potential exposure to adults.

2. Infants and children. Cabot

Corporation believes that sufficient

information has been submitted to

assess the hazards of

hexamethyldisilizane, reaction product

with silica. Because

hexamethyldisilizane, reaction product

with silica conforms with the definition

of a polymer and meets the criteria of

a polymer under 40 CFR 723.250, Cabot

Corporation believes there are no

concerns for risks associated with

exposure to infants and children.

[FR Doc. 00–16633 Filed 6–29–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6727–4]

Draft EPA Guidance for Community

Involvement in Supplemental

Environmental Projects

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: The Office of Enforcement

and Compliance Assurance (EPA) is

noticing a draft document, ‘‘Guidance

for Community Involvement in

Supplemental Environmental Projects,’’

for comment. This document is

intended to provide guidance to EPA

personnel on how to achieve the

community involvement objectives of

the 1998 Supplemental Environmental

Projects Policy (SEP Policy). EPA is

soliciting public comments on this

guidance to assist it in addressing issues

such as identifying communities

affected by enforcement actions,

facilitating the outreach process,

encouraging realistic community

expectations, and using liaisons to

facilitate communication.

DATES: Comments are due on or before

August 29, 2000.

ADDRESSES: Mail written comments to

the Enforcement and Compliance

Docket and Information Center (2201A),

Docket Number EC–G–2000–055, Office

of Enforcement and Compliance

Assurance, U.S. Environmental

Protection Agency, 1200 Pennsylvania

Avenue, NW., Washington, DC 20460.

(Comments may be submitted on disk in

WordPerfect 8.0 or earlier versions.)

Written comments may be delivered in

person to: Enforcement and Compliance

Docket and Information Center, U.S.

Environmental Protection Agency,

Room 4033, Ariel Rios Bldg., 1200

Pennsylvania Avenue, NW.,

Washington, DC. Submit comments

electronically to docket.oeca@epa.gov.

Electronic comments may be filed

online at many Federal Depository

Libraries.

FOR FURTHER INFORMATION CONTACT:

Melissa Raack, 202–564–7039, Office of

Regulatory Enforcement, Mail Code

2248–A, United States Environmental

Protection Agency, 1200 Pennsylvania

Avenue, NW., Washington, DC 20460, email: raack.melissa@epa.gov.

SUPPLEMENTARY INFORMATION: In its

Supplemental Environmental Projects

Policy of May 1, 1998, EPA affirmed its

commitment to involve communities in

the consideration of SEPs in appropriate

enforcement cases. Although there is no

formula for effective community