Federal Register / Vol. 66, No. 85 / Wednesday, May 2, 2001 / Notices 21973

NOAEL for reproductive and

developmental toxicity was also 250

ppm on the basis of reduced pup

weights. No other reproductive or

developmental parameters were affected

at any treatment level. The highest dose

tested was 1,250 ppm (110 mg/kg/day).

4. Subchronic toxicity. In 90–day rat

studies, the NOAEL was determined to

be 500 ppm in the diet (44 mg/kg/day),

and the LOAEL was based upon

increased liver weights in both sexes

and centrilobular hepatocyte

enlargement in males. Similar effects, as

well as an increase in blood cholesterol

concentration, were observed in 90–day

mouse studies, and the NOAEL was 15

mg/kg/day.

5. Chronic toxicity. EPA has

established the reference dose (RfD) for

dicloran at 0.025 mg/kg/day. The RfD is

based on a 2–year dog feeding study

with a NOAEL of 2.5 mg/kg/day and an

uncertainty factor of 100. The effect of

concern was increased liver weight and

histological changes in hepatocytes. In

an 80–week mouse study, dicloran was

not carcinogenic when administered at

dose levels up to 600 ppm (103 mg/kg/

day). Hepatotoxicity indicated this to be

the approximate maximum tolerated

dose (MTD). In a 2–year rat study,

dicloran was not carcinogenic when

administered at 1,000 ppm (59 mg/kg/

day for males and 71 mg/kg/day for

females).

6. Animal metabolism. Dicloran is

rapidly metabolized and excreted by

rats, goats and hens. Numerous

metabolites derived by reduction,

acetylation, hydroxylation, deamination

and dechlorination were observed.

7. Endocrine disruption.

Developmental toxicity studies in rats

and rabbits and a reproduction study in

rats gave no indication of any effects on

endocrine function related to

development and reproduction.

Subchronic and chronic treatment did

not induce any morphological changes

in endocrine organs and tissues.

C. Aggregate Exposure

1. Dietary exposure—i. Food. Novigen

Sciences’ DEEM version 7.62 software

was used to perform a worst-case

analysis of the proposed action. In a

theoretical maximum residue

concentration (TMRC) analysis it was

assumed that dicloran is used on 100%

of the acreage of the currently registered

crops, lettuce and endive, and that

residues on these crops are equal to the

tolerance levels. These assumptions

were then applied to all of the crops in

the leafy greens subgroup (except

spinach), and the two cases were

compared. It was found that the

proposed tolerance for the leafy greens

subgroup (except spinach) would

increase the presumed exposure from

9.7% of the RfD to 9.9% for the general

population. In the presumably most

heavily exposed population subgroup,

nursing females, exposure would

increase from 11.8% to 11.9% of the

RfD. Presumed exposure for children

ages 1–6 would increase from 7.5% to

7.9%, and the presumed exposure for

children ages 7–12 would increase from

9.0% to 9.2% of the RfD. The presumed

exposure of infants was no more than

0.2% of the RfD for any scenario.

No developmental or reproductive

effects have been observed which

indicate special perinatal sensitivity.

Therefore, an analysis of acute exposure

has not been conducted.

ii. Drinking water. Dicloran has no

aquatic uses. Dicloran was not reported

in the Agency’s survey of pesticides in

ground water from 1971–1991, nor in

the Agency’s 1988–1990 survey of

pesticides in drinking water wells. The

compound has not been reported in

surface water. A small scale prospective

ground water study suggests that the

average residue in ground water is well

below 0.001 ppm. The Agency has not

conducted a detailed analysis of

potential exposure to dicloran via

drinking water; however, Gowan

Company believes that chronic exposure

from this source is very small.

2. Non-dietary exposure. Dicloran has

no aquatic, lawn, turf or residential

uses.

D. Cumulative Effects

At this time the Agency has not

reviewed available information

concerning the potentially cumulative

effects of dicloran and other substances

that may have a common mechanism of

toxicity. For purposes of this petition

only, Gowan Company is considering

only the potential risks of dicloran in its

aggregate exposure.

E. Safety Determination

1. U.S. population. In the TMRC

analysis described in section C above, it

was concluded that the proposed action

would increase the chronic dietary

exposure to dicloran by no more than

0.2% of the RfD for the general

population. Exposure from drinking

water and all other routes is expected to

be negligible. In the TMRC analysis

described in section C above, it was

concluded that the proposed action

would increase the chronic dietary

exposure to dicloran by no more than

0.2% of the RfD for the general

population. Exposure from drinking

water and all other routes is expected to

be negligible.

2. Infants and children. It was

concluded that the proposed action

would increase the chronic dietary

exposure of infants by no more than

0.1% of the RfD, of children ages 1–6 by

no more than 0.4%, and of children ages

7–12 by no more than 0.2%.

In assessing the potential for

additional sensitivity of infants and

children to residues of dicloran, EPA

considers data from developmental

toxicity studies in the rat and rabbit and

reproduction studies in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

No developmental effects have been

observed with dicloran. The lowest

embryotoxic NOAEL in these studies

was 100 mg/kg/day, compared to a

chronic NOAEL of 2.5 mg/kg/day. There

is no indication of special perinatal

sensitivity in the absence of maternal

toxicity and thus no suggestion of

special sensitivity of infants and

children. Gowan Company concluded

that there is a reasonable certainty of no

harm to infants and children from

aggregate exposure to dicloran residues.

F. International Tolerances

Codex and Canadian maximum

residue levels of 10 ppm, identical to

the U.S. tolerance level, have been

established for lettuce, which is the

major crop in this crop subgroup.

Dicloran is not registered on a leafy

vegetable in Mexico.

[FR Doc. 01–10809 Filed 5–1–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–992; FRL–6762–8]

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.

21974 Federal Register / Vol. 66, No. 85 / Wednesday, May 2, 2001 / Notices

DATES: Comments, identified by docket

control number PF–992, must be

received on or before June 1, 2001.

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–992 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Carol E. Frazer, PhD.,

Biopesticides and Pollution Prevention

Division, Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–8810; e-mail address: frazer.carol

@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

code

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,’’ ‘‘Regulatations

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–

992. 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–992 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–992. 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.

Federal Register / Vol. 66, No. 85 / Wednesday, May 2, 2001 / Notices 21975

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: April 19, 2001.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention 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

FFDCA. The summary of the petition

was prepared by the petitioner and

represents the view of the petitioners.

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.

EPA has received a pesticide petition

0G6222 from Nutra-Park Inc., formerly

known as JP BioRegulators, Inc., 3230

Deming Way, Suite 125, Middleton, WI

53562, through Interregional Research

Project Number 4 (IR-4), Technology

Centre of New Jersey, Rutgers

University, 681 U.S. Highway #1 South,

proposing pursuant to section 408(d) of

the Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 USC 346a(d), to amend

40 CFR part 180 to establish an

amendment/expansion of an existing

tolerance exemption for the biochemical

pesticide

Lysophosphatidylethanolamine, also

known as Lyso-PE and LPE.

Pursuant to section 408(d)(2)(A)(i) of

the FFDCA, as amended, Nutra-Park Inc.

has submitted the following summary of

information, data, and arguments in

support of their pesticide petition. This

summary was prepared by Nutra-Park

Inc. and EPA has not fully evaluated the

merits of the pesticide petition. The

summary may have been edited by EPA

if the terminology used was unclear, the

summary contained extraneous

material, or the summary

unintentionally made the reader

conclude that the findings reflected

EPA’s position and not the position of

the petitioner.

Nutra-Park Inc.

PP 0G622

A. Product Name and Proposed Use

Practices

Lysophosphatidylethanolamine, a

specific type of phospholipid, is used to

enhance the ripening and shelf life of

the following fruits: Apples, citrus,

cranberries, grapes, nectarines, peaches,

pears, strawberries, tomatoes,

blueberries, peppers, and cherries.

Phospholipid enhances ethylene

production thus stimulating and

promoting ripening, but does not

enhance respiration so that fruit stays

firmer and has a longer shelf life.

Lysophosphatidylethanolamine is

sprayed at the rate of 12–500 ppm of

active ingredient. Application rate will

be 50–200 gallons per acre. Preharvest

applications are made May through

October and post-harvest application, by

dipping fruit in solution and air drying,

is extended into December. Treatment is

made either 2 weeks prior to harvest or

within 1–4 weeks after harvest.

B. Product Identity/Chemistry

1. Identity of the pesticide and

corresponding residues. The active

ingredient is

lysophosphatidylethanolamine, a

specific type of phospholipid. The

mechanism by which phospholipid

enhances ripening is as a growth

regulator. It has been observed

empirically that phospholipid

stimulates ethylene production, but not

respiration of plant tissues although the

exact mechanism is not fully

understood. Phospholipid is present in

all cells in all organisms. It is part of cell

membranes. About 50% of the cell

membrane is composed of lipid of

which the major constituent is

phospholipid. Lyso-PE (a specific

member of the phospholipid group) is

present in high quantities in food

products containing egg yolk and meat.

In dried egg yolk, Lyso-PE constitutes

2% of the lipids present. Lyso-PE is also

found in egg solids, cow’s milk, corn

grains, corn starch, oats and wheat

which are exempted from regulation

under section 25(b)(2) of FIFRA.

2. Magnitude of residue at the time of

harvest and method used to determine

the residue. This section is not

applicable, as this proposes a temporary

exemption from the requirement of a

tolerance.

3. A statement of why an analytical

method for detecting and measuring the

levels of the pesticide residue are not

needed . An analytical method for

residues is not applicable, as this

proposes a temporary exemption from

the requirement of a tolerance.

C. Mammalian Toxicological Profile

Waivers for toxicology studies have

been requested for phospholipid.

Phospholipid is a fat found in food

consumed by humans and animals, and

is non-toxic to humans and animals.

Sufficient data exist to assess the

hazards of phospholipid and to make a

determination on aggregate exposure,

consistent with section 408 (c)(2), for

the exemptions from the requirement of

a tolerance. The exposures, including

dietary exposure, and risks associated

with establishing the requested

exemption from the requirement of a

tolerance follows.

Phospholipid is present in all cells in

all organisms. It is part of the cell

membranes. Lyso-PE (a specific

phospholipid) is present in high

quantities in food products containing

egg yolk and meat. In dried egg yolk, the

Lyso-PE constitutes 2% of the fat

present. Egg solids are widely used in

food products. In the USA, about 18

billion eggs are broken per year to

produce egg white and egg solids.

Because of this, all acute toxicity,

genotoxicity, and subchronic toxicity

studies normally required for

biochemical pesticides are waived.

D. Aggregate Exposure

Phospholipid is present in all cells in

all organisms. It is a part of the cell

membrane. Phospholipid is present in

high quantities in food products

containing egg yolk and meat.

1. Dietary exposure—i. Food. It is

anticipated that residues of

phospholipid will be negligible in

treated raw agricultural commodities.

Due to the product’s lack of mammalian

toxicity, any exposure, if it occurred,

will not be harmful to humans.

ii. Drinking water. It is not

anticipated that residues of

phospholipid will occur in drinking

water.

2. Non-dietary exposure. Nutra-Park

Inc. is not aware of any non-dietary

exposures.

E. Cumulative Exposure

There is no anticipated potential for

cumulative effects of phospholipid

since it does not have a mode of

21976 Federal Register / Vol. 66, No. 85 / Wednesday, May 2, 2001 / Notices

toxicity. No cumulative effects are

expected with other substances.

F. Safety Determination

1. U.S. population. The lack of

toxicity of phospholipid is

demonstrated by the above summary.

Based on this information, the aggregate

exposure to phospholipid over a

lifetime should not pose appreciable

risks to human health. There is a

reasonable certainty that no harm will

result from aggregate exposure to

phospholipid residues. Exempting

phospholipid from the requirement of a

temporary tolerance should be

considered safe and pose insignificant

risk.

Egg solids are widely used in food

products. In dried egg yolk, 2% of the

lipids are Lyso-PE.

2. Infants and children. Egg yolks are

used in a variety of foods including

baby food and infant formula. Lyso-PE

is also present in human breast milk.

There is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure to

phospholipid residues.

G. Effects on the Immune and Endocrine

Systems

Nutra-Park Inc. has no information to

suggest that phospholipid will adversely

affect the immune or endocrine systems.

H. Existing Tolerances

A temporary tolerance exemption on

apples, citrus, cranberries, grapes,

nectarines, peaches, pears, strawberries

and tomatoes in conjunction with

Experimental Use Permits for

lysophosphatidylethanolamine is

currently in effect (63 FR 32131) June

12, 1998, and has been extended to June

2003.

I. International Tolerances

Nutra-Park Inc. is not aware of any

international tolerances of this

biochemical.

[FR Doc. 01–11000 Filed 5–1–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6972–5]

Boro Wood Products Superfund Site;

Notice of Proposed Settlement

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of proposed settlement.

SUMMARY: The United States

Environmental Protection Agency is

proposing to enter into a settlement

with Southeastern Modular Homes, Inc.,

for response costs pursuant to section

122(h)(1) of the Comprehensive

Environmental Response,

Compensation, and Liability Act

(CERCLA), 42 U.S.C. 9622(h)(1)

regarding the Boro Wood Products

Superfund Site located in Bennettsville,

Marlboro County, South Carolina. EPA

will consider public comments on the

proposed settlement for thirty (30) days.

EPA may withdraw from or modify the

proposed settlement should such

comments disclose facts or

considerations which indicate the

proposed settlement is inappropriate,

improper or inadequate. Copies of the

proposed settlement are available from:

Ms. Paula V. Batchelor, U.S. EPA,

Region 4 (WMD–CPSB), 61 Forsyth

Street SW, Atlanta, Georgia 30303, (404)

562–8887.

Written comments may be submitted

to Ms. Batchelor within 30 calendar

days of the date of this publication.

Dated: April 11, 2001.

Franklin E. Hill,

Chief, CERCLA Program Services Branch,

Waste Management Division.

[FR Doc. 01–10996 Filed 5–1–01; 8:45 am]

BILLING CODE 6560–50–P

EXPORT-IMPORT BANK

[Public Notice 44]

Agency Information Collection

Activities; Proposed Collection;

Comment Request

AGENCY: Export-Import Bank of the

United States.

ACTION: Notice and request for

comments.

SUMMARY: The Export-Import bank as a

part of its continuing effort to reduce

paperwork and respondent burden,

invites the general public and other

Federal agencies to comment on the

proposed information collection, as

required by the Paperwork Reduction

Act of 1995.

DATES: Written comments should be

received on or before June 30, 2001 to

be assured of consideration.

ADDRESSES: Direct all written comments

and request for additional information

to Carlista Robinson, 811 Vermont

Avenue, NW., Room 764, Washington,

DC 20571, (202) 565–3351.

SUPPLEMENTARY INFORMATION:

Title & Form Number: Ex-Im Bank

Letter of Interest Application form—EIB

Form 95–9.

OMB Number: 3048–0005.

Type of Review: Reinstatement,

without change, of a previously

approved collection.

Need and Use: The information

requested enables the applicant to

provide Ex-Im Bank with the

information necessary to determine

eligibility for an indicative offer of

support under the loan and guarantee

programs.

Affected Public: Business or other forprofit.

Respondents: Entities involved in the

provision of financing or arranging of

financing for foreign buyers of U.S.

exports.

Estimated Annual Respondents: 960.

Estimated Time Per Respondent: 20

minutes.

Estimated Annual Burden: 300.

Frequency of Response: When

applying for a Letter of Interest.

Dated: April 26, 2001.

Carlista D. Robinson,

Agency Clearance Officer.

BILLING CODE 6690–01–M