Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 / Notices 32211

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Comment and data will

also be accepted on disks in

Wordperfect 5.1/6.1 or ASCII file

format. All comments and data in

electronic form must be identified by

the docket number [OPP–30456].

Electronic comments on this notice may

be filed online at many Federal

Depository Libraries.

Authority: 7 U.S.C. 136.

List of Subjects

Environmental protection, Pesticides

and pests, Product registration.

Dated: May 22, 1998.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 98–15741 Filed 6–11–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–809; FRL–5792–7]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing to establish an exemption

from the requirement of a tolerance for

copper ammonium complex in or on all

raw agricultural commodities.

DATES: Comments, identified by the

docket control number PF–809, must be

received on or before July 13, 1998.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticides Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. In

person bring comments to: Rm. 119, CM

#2, 1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically by following

the instructions under

‘‘SUPPLEMENTARY INFORMATION.’’

No confidential business information

should be submitted through e-mail.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

that does not contain CBI must be

submitted for inclusion in the public

record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice. All written

comments will be available for public

inspection in Rm. 119 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: The

product manager listed in the table

below:

Product Manager Office location/telephone number Address

Cynthia Giles-Parker ...... Rm. 247, CM #2, 703–305–7740, e-mail: giles-parker.cynthia@epamail.epa.gov. 1921 Jefferson Davis Hwy, Arlington, VA

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition as follows

from Chemical Specialties, Inc., One

Woodlawn Green, Suite 250, Charlotte,

N.C. 28217, proposing pursuant to

section 408(d) of the Federal Food, Drug

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

amend 40 CFR part 180 to establish an

exemption from the requirement of a

tolerance for copper ammonium

complex in or on all raw agricultural

commodities when used in accordance

with good agricultural practice as an

active ingredient in pesticide

formulations applied to growing crops.

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.

The official record for this notice of

filing, as well as the public version, has

been established for this notice of filing

under docket control number [PF–809]

(including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The official

record is located at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Comment and data will

also be accepted on disks in

Wordperfect 5.1/6.1 file format or ASCII

file format. All comments and data in

electronic form must be identified by

the docket control number [PF–809] and

appropriate petition number. Electronic

comments may be filed online at many

Federal Depository Libraries.

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated: June 2, 1998.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summaries of Petitions

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

views of the petitioner. EPA is

publishing the petition summary

verbatim without editing them in any

way.

Chemical Specialties, Inc.

PP 8F4959

EPA has received a pesticide petition

(PP 8F4959) from Chemical Specialties,

Inc., One Woodlawn Green, Suite 250,

Charlotte, N.C. 28217, proposing

pursuant to section 408(d) of the Federal

Food, Drug and Cosmetic Act, 21 U.S.C.

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

establish an exemption from the

requirement of a tolerance for copper

ammonium complex in or on all raw

agricultural commodities when used in

accordance with good agricultural
32212 Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 / Notices

practice as an active ingredient in

pesticide formulations applied to

growing crops. 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 supports

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

A. Residue Chemistry

1. Plant metabolism. No plant

metabolism studies have been submitted

in support of this tolerance exemption

petition since copper ammonium

complex forms, upon aqueous dilution,

copper hydroxide. Accordingly, the

actual plant residue is copper, which is

an essential trace element critical for the

propagation of plants.

2. Analytical method. Since the

petitioner has requested a tolerance

exemption, a residue analytical method

is not required.

3. Magnitude of residues. No crop

residue studies were conducted since

copper is naturally found at significant

levels ( > 1 ppm) in many different types

of food. In addition, residue trials are

not practical since it is very difficult to

distinguish copper residues from

naturally occurring copper versus

copper residues from copper

ammonium complex.

B. Toxicological Profile

Acute toxicity. The acute oral LD50 for

a 31.4% solution of copper ammonium

complex is approximately than 2,200

milligrams/kilogram (mg/kg).

Accordingly, copper ammonium

complex is relatively non-toxic by the

oral route.

The petitioner has requested that the

Agency waive all sub-chronic, chronic/

oncogenicity, mutagenicity,

developmental and reproductive

toxicity study requirements for copper

ammonium complex. The basis for this

request is that the dietary residue is

copper and the Agency has previously

concluded (refer to the Toxicology

Chapter for Group II Copper

Compounds) that:

1. Copper is essential for well-being in

humans.

2. Humans possess a natural efficient

homeostatic mechanism for regulating

copper body levels over a wide range of

dietary intake.

3. There is an overwhelming lack of

evidence for any chronic effects induced

by dietary ingestion of copper unless the

intake is of such enormous magnitude

that there is a disruption of the natural

homeostatic mechanism for controlling

body levels.

C. Aggregate Exposure

1. Dietary exposure. Twelve FDA total

diet studies, conducted from mid 1982–

1984, examined dietary intake of copper

for age groups 14–16, 25–30 and 60–65

years. The copper intake ranged from

0.77 (14–16 year old females) to 1.24

mg/day (25–30 year old males). .

2. Food. Copper is naturally found in

several types of foods, such as fruits and

vegetables, at levels ranging from 0.3–

3.9 ppm.

3. Drinking water. A 1987 EPA report

noted that the average copper

concentration in drinking water is

approximately 130 ppb and a little over

1% of drinking water exceeds the

Maximum Contaminant Level (MCL) of

1 ppm.

4. Non-dietary exposure. Air

concentrations of copper, based on

several thousand samples assembled by

EPA’s Environmental Monitoring

Systems Laboratory, ranges from 0.003–

7.32 μg/m3.

Using the above exposure values, the

petitioner estimates that the aggregate

exposure to copper from food, drinking

water and air ranges from < 1 to 3 mg/

day. Consequently, the petitioner

anticipates that the use of copper

ammonium complex as a pre-harvest

fungicide on established crops will, at

most, make a negligible contribution to

existing aggregate copper exposure.

D. Cumulative Effects

No cumulative adverse effects are

expected from long-term exposure to

copper ammonium copper.

E. Safety Determination

1. U.S. population. Several copper

compounds, such as copper sulfate, are

currently approved for use on food

crops (40 CFR 180.1001(b)(1). Since

copper ammonium complex is a

substitute for these copper compounds,

and, under use-conditions, releases

equivalent amounts of copper, approval

of this petition will not increase dietary

exposure to copper. Moreover, copper is

an essential trace element for which the

National Academy of Sciences has

issued a recommended daily allowance

of up to 3 mg/day for adults.

Accordingly, there is reasonable

certainty that no harm will result from

aggregate exposure of the U.S.

population to copper.

2. Infants and children. Since copper

is also an essential trace element for

infants and children and the

contribution to daily copper exposure

from the use of copper ammonium

complex is anticipated to be trivial, no

adverse effects on infants or children are

expected.

F. International Tolerances

There are no approved CODEX

maximum residue levels (MRLs)

established for residues of copper

ammonium complex.

[FR Doc. 98–15596 Filed 6–11–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6110–6]

Research Strategy for Oxygenates in

Water

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of availability of external

review draft.

SUMMARY: This document announces the

availability of an external review draft

of a document, Research Strategy for

Oxygenates in Water, EPA/600/R–98/

048, prepared by the Office of Research

and Development of the U.S.

Environmental Protection Agency. The

purpose of this document is to identify

key issues related to assessing and

managing the potential health and

environmental risks of water

contamination by oxygenates. The term

oxygenates refers to chemicals added to

fuels (which then may be known as

‘‘oxyfuels’’) to increase the oxygen

content and thereby reduce certain

emissions from use of the fuel. This

research strategy builds on and extends

an earlier document, Oxyfuels

Information Needs (U.S. Environmental

Protection Agency, 1996, EPA/600/R–

96/069), which included water issues

but tended to focus more on inhalation

health risk issues. As a research

strategy, the present document focuses

on those gaps and limitations in current

information that constitute the most

critical and immediate needs to be

addressed. The document is primarily

intended to serve as a starting point and

general guide to planning needed

research. It is not a comprehensive

review of issues related to oxygenates in

water, and it does not attempt to specify

in detail the specific studies and

projects that may be needed. An earlier

draft of this document was peer

reviewed in a workshop held on

October 7, 1997, in Washington, DC.

Comments received on the workshop

draft were considered in preparing the

current external review draft.

DATES: Anyone who wishes to comment

on this document may do so in writing