58078 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Notices

respectively, of the DWLOC. Therefore,

the exposures to drinking water from

imazethapyr use are negligible.

2. Non-dietary exposure. Imazethapyr

products are notcurrently registered or

requested to be registered for residential

use; therefore the estimate of residential

exposure is not relevant to this tolerance

petition.

D. Cumulative Effects

Imazethapyr is a member of the

imidazolinone class of herbicides. Other

compounds of this class are registered

for use in the United States. However,

the herbicidal activity of the

imidazolinones is due to the inhibition

of acetohydroxyacid synthase (AHAS),

an enzyme only found in plants. AHAS

is part of the biosynthetic pathway

leading to the formation of branched

chain amino acids. Animals lack AHAS

and this biosynthetic pathway. This lack

of AHAS contributes to the low toxicity

of the imidazolinone compounds in

animals. We are aware of no information

to indicate or suggest that imazethapyr

has any toxic effects on mammals that

would be cumulative with those of any

other chemical. Therefore, for the

purposes of this tolerance petition no

assumption has been made with regard

to cumulative exposure with other

compounds having a common mode of

action.

E. Safety Determination

1. U.S. population. The RfD

represents the level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. In 990, the EPA set the

RfD for imazethapyr at 0.25 mg/kg bwt/

day, based on the NOAEL from the 1–

year dietary toxicity study in dogs of 25

mg/kg bwt/day and a 100–fold

uncertainty factor. The chronic dietary

exposure of 0.000419 mg/kg bwt/day for

the general U.S. population will utilize

only 0.2% of the RfD of 0.25 mg/kg bwt/

day. EPA generally has no concern for

exposures below 100% of the RfD. Due

to the low toxicity of imazethapyr, an

acute exposure dietary risk assessment

is not warranted. The complete and

reliable toxicity data base, the low

toxicity of the active ingredient, and the

results of the chronic dietary exposure

risk assessment, support the conclusion

that there is a ‘‘reasonable certainty of

no harm’’ from the proposed use of

imazethapyr on imidazolinone tolerant

rice. Furthermore, these factors support

the proposed tolerance on rice.

2. Infants and children. The

conservative dietary exposure estimates

of all registered uses including the

proposed tolerance for rice show

exposures of 0.001104, 0.000440,

0.000870, and 0.000610 mg/kg bwt/day

which will utilize 0.4, 0.2, 0.3, and

0.2% of the RfD for all infants (<1 year),

nursing infants, children 1-6 years, and

children 7-12 years, respectively. The

chronic dietary exposures for nonnursing infants, the most highly

exposed subgroup, will utilize only

0.5% of the RfD. Results from the 2–

generation reproduction study in rats

and the developmental toxicity studies

in rabbits and rats indicate no increased

sensitivity to developing offspring when

compared to parental toxicity. These

results also indicate that imazethapyr is

neither a developmental toxicant nor a

teratogen in either the rat or rabbit.

Therefore, an additional safety factor is

not warranted, and the RfD of 0.25 mg/

kg bwt/day, which utilizes a 100–fold

safety factor is appropriate to ensure a

reasonable certainty of no harm to

infants and children.

F. International Tolerances

There are no Codex maximum residue

levels established or proposed for

residues of imazethapyr on rice.

[FR Doc. 00–24680 Filed 9–26–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–972; FRL–6742–4]

Notice of Filing a Pesticide Petition to

Establish a Tolerance for a Certain

Pesticide Chemical in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

regulations for residues of a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–972, must be

received on or before October 27, 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–972 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Bipin Gandhi, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–8380; e-mail address:

gandhi.bipin@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,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number PF–

972. 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

Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Notices 58079

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–972 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–972. 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.

II. What Action is the Agency Taking?

EPA has received a pesticide petition

as follows proposing the establishment

and/or amendment of regulations for

residues of a certain pesticide chemical

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

this petition contains 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 support 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: September 15, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summary of Petition

The petitioner summary of the

pesticide petition is printed below as

required by section 408(d)(3) of the

Federal Food Drug and Cosmetic Act

(FFDCA). The summary of the petition

was prepared by the petitioner and

represents the view of the petitioner.

EPA is publishing the petition summary

verbatim without editing it in any way.

The petition summary announce 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.

DuPont Company

PP 6E4785

EPA has received a pesticide petition

(PP 6E4785) from the DuPont Company,

DuPont Fluoroproducts, Chestnut Run

Plaza, P.O. Box 80711, Wilmington, DE,

19880–0711 proposing, pursuant to

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

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

establishing a tolerance for residues of

dimethylether (CAS Reg. No. 115–10–6)

when used as an inert ingredient in

pesticide formulations applied to

growing crops or to raw agricultural

commodities (RAC) after harvest, and

including area application in and

around commercial and residential food

handling facilities and establishments

by certified applicators only. 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

Analytical method. DME is used as a

propellant in pesticide formulations and

exists as a gas at ambient conditions.

Upon release from the container, it

vaporizes completely with essentially

no residue; consequently, no analytical

method for residue measurement is

needed.

58080 Federal Register / Vol. 65, No. 188 / Wednesday, September 27, 2000 / Notices

B. Toxicological Profile

Since dimethylether (DME) exists as a

gas at room temperature and any

exposure to humans would occur via

inhalation, all toxicity testing conducted

with DME was done via inhalation or in

the vapor phase.

1. Acute toxicity. An acute inhalation

toxicity study was conducted in rats.

The 4–hr LC50 was determined to be

164,000 parts per million (ppm), EPA

category IV.

2. Genotoxicty—i. An in vitro Ames/

Salmonella mutagenicity assay in five

commonly used strains was negative for

mutagenic potential.

ii. An in vitro chromosomal aberration

test in cultured human lymphocytes

was negative for chromosomal

aberrations.

3. Reproductive and developmental

toxicity—i. Reproductive organs in male

and female rats were examined

histopathologically following inhalation

of 0, 2,000, 10,000, or 25,000 ppm DME

for 6, 12, 16, and 24 months. The no

observed adverse effect level (NOAEL)

in this study was 25,000 ppm as no

compound-related effects on the

reproductive organs of either male or

female rats were observed.

ii. Developmental toxicity testing was

conducted in rats exposed via

inhalation to DME during days 6–15 of

gestation. Fetal body weight (bwt) was

decreased at the 20,000 and 40,000 ppm

levels (of borderline statistical

significance in the 20,000 ppm group)

and there was an increased incidence of

several skeletal variations (partial rib

development in the lumbar region and

partial or complete doubling of one or

more vertebral centra). The NOAEL for

the conceptus was 1,250 ppm. In

comparison to maternal effect levels,

DME was not demonstrated to represent

a unique hazard to the rat conceptus.

4. Subchronic toxicity. Male and

female Wistar rats were exposed to 0,

200, 2,000, or 20,000 ppm DME via

inhalation for 30 weeks. At the 20,000

ppm level, male rats showed a

significant reduction in liver weight

accompanied by raised serum glutamic

pyruvic transaminase (SGPT) levels. In

the 20,000 ppm females, there was no

significant effect on liver weight but

SGPT levels were raised. The NOAEL in

this study was 2,000 ppm.

5. Chronic toxicity. A 2–year DME

inhalation study was conducted in rats

for 6 hours/day, 5 days/week at

concentrations of 0, 2,000, 10,000, or

25,000 ppm. The NOAEL was 2,000

ppm based on an increase in bwt and a

decrease in survival in male rats

exposed to 10,000 or 25,000 ppm DME

vapors and on hemolytic effects noted

in male rats exposed to 25,000 ppm

DME vapors for 6 months. No neoplastic

lesions were observed that could be

attributable to DME exposure. DME was

not carcinogenic.

6. Animal metabolism. Dimethylether

is a volatile, stable compound. While no

metabolism studies were identified, the

primary route of DME elimination from

the body is likely to be exhalation of

parent compound.

7. Endocrine disruption. No adverse

endocrine effects have been suggested or

reported in any toxicity tests conducted

with DME.

C. Aggregate Exposure

1. Dietary exposure. Dimethylether

exists as a vapor at atmospheric

pressure and ambient temperatures. It is

handled and contained in aerosol

products as a liquefied gas under its

own vapor pressure which is 63 psig at

70°F. Upon release from container

pressure, as when product is dispensed,

dimethylether vaporizes completely

with essentially no residue.

Dimethylether is intended as an inert

ingredient and propellant for pesticide

formulations applied in food handling

areas and establishments; these

products are not intended for direct

application to foods. Dietary exposure

from use of dimethylether in these types

of products is believed to be minimal,

as discussed in food and drinking water

below.

i. Food. Based on its physical

properties, when dimethylether is used

as a propellant in pesticide formulations

applied in food handling areas and

establishments, no residue is expected

on or in food. Upon dispensing the

insect control product, the

dimethylether will vaporize and

dissipate quickly, affording no residue

or accumulation.

ii. Drinking water. Similarly, since

dimethylether will vaporize completely

at ambient conditions, no accumulation

is expected in drinking water. There

would be no liquid dimethylether to

migrate to groundwater aquifers or

surface water bodies that may serve as

suitable drinking water sources.

2. Non-dietary exposure. The greatest

potential for residential exposure to

dimethylether would be via inhalation

routes. However, even when these

pesticide products are used in small

areas, estimated dimethylether levels

will be lower and of much shorter

duration than recognized and accepted

levels that are considered safe for

chronic lifetime exposures.

Additionally, tests have shown that

such aerosol propellants dissipate

within minutes of use.

D. Cumulative Effects

There is no reliable information that

would indicate or suggest that

dimethylether has any toxic effect on

mammals that would be cumulative

with those of any other chemical.

E. Safety Determination

1. U.S. population. Since potential

dietary exposures are expected to be

minimal, if any, and since potential

inhalation exposures are estimated

much lower than recognized and

accepted levels considered safe for

chronic lifetime exposures,

dimethylether is not likely to pose any

significant risk to the general U.S.

population.

2. Infants and children. To the best of

our knowledge, there is no information

that suggests infants and children are

more susceptible to exposure to or

effects of dimethylether. The lack of

significant toxicity in reproductive/

developmental studies on dimethylether

suggests that growing organisms are not

at increased risks. Since potential

dietary exposures to infants and

children are minimal, if any, based on

anticipated use, it is unlikely that any

significant risks exist. Direct exposures

to infants and children via inhalation

are not anticipated for the intended use

of dimethylether.

F. International Tolerances

DuPont is not aware of any tolerances

for dimethylether outside the United

States.

[FR Doc. 00–24438 Filed 9–26–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–977; FRL–6746–4]

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 filing of pesticide petitions

proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by docket

control number PF–977, must be

received on or before October 27, 2000.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as