This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

public. Notices of hearings and investigations,

committee meetings, agency decisions and

rulings, delegations of authority, filing of

petitions and applications and agency

statements of organization and functions are

examples of documents appearing in this

section.

Notices Federal Register

38805

Vol. 63, No. 138

Monday, July 20, 1998

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 98–067–1]

Monsanto Co.; Receipt of Petition for

Determination of Nonregulated Status

for Potato Lines Genetically

Engineered for Insect and Virus

Resistance

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice.

SUMMARY: We are advising the public

that the Animal and Plant Health

Inspection Service has received a

petition from Monsanto Company

seeking a determination of nonregulated

status for certain potato lines genetically

engineered for resistance to the

Colorado potato beetle and potato virus

Y. The petition has been submitted in

accordance with our regulations

concerning the introduction of certain

genetically engineered organisms and

products. In accordance with those

regulations, we are soliciting public

comments on whether these potato lines

present a plant pest risk.

DATES: Written comments must be

received on or before September 18,

1998.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 98–067–1, Regulatory

Analysis and Development, PPD,

APHIS, Suite 3C03, 4700 River Road

Unit 118, Riverdale, MD 20737–1238.

Please state that your comments refer to

Docket No. 98–067–1. A copy of the

petition and any comments received

may be inspected at USDA, room 1141,

South Building, 14th Street and

Independence Avenue SW.,

Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday,

except holidays. Persons wishing access

to that room to inspect the petition or

comments are asked to call in advance

of visiting at (202) 690–2817 to facilitate

entry into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr.

David Heron, Biotechnology and

Biological Analysis, PPQ, APHIS, Suite

5B05, 4700 River Road Unit 147,

Riverdale, MD 20737–1236; (301) 734–

5141. To obtain a copy of the petition,

contact Ms. Kay Peterson at (301) 734–

4885; e-mail: Kay.Peterson@usda.gov.

SUPPLEMENTARY INFORMATION: The

regulations in 7 CFR part 340,

‘‘Introduction of Organisms and

Products Altered or Produced Through

Genetic Engineering Which Are Plant

Pests or Which There Is Reason to

Believe Are Plant Pests,’’ regulate,

among other things, the introduction

(importation, interstate movement, or

release into the environment) of

organisms and products altered or

produced through genetic engineering

that are plant pests or that there is

reason to believe are plant pests. Such

genetically engineered organisms and

products are considered ‘‘regulated

articles.’’

The regulations in § 340.6(a) provide

that any person may submit a petition

to the Animal and Plant Health

Inspection Service (APHIS) seeking a

determination that an article should not

be regulated under 7 CFR part 340.

Paragraphs (b) and (c) of § 340.6

describe the form that a petition for

determination of nonregulated status

must take and the information that must

be included in the petition.

On December 5, 1997, APHIS received

a petition (APHIS Petition No. 97–339–

01p) from Monsanto Company

(Monsanto) of St. Louis, MO, requesting

a determination of nonregulated status

under 7 CFR part 340 for certain

NewLeaf Y potato lines. The subject

potato lines include one line of Russet

Burbank (RBMT15–101), two lines of

Shepody (SEMT15–02 and SEMT15–

15), and one line of HiLite (HLMT15–

46), which have been genetically

engineered for resistance to the

Colorado potato beetle (CPB) and potato

virus Y (PVY). The Monsanto petition

states that the subject potato lines

should not be regulated by APHIS

because they do not present a plant pest

risk.

As described in the petition, all four

of the subject NewLeaf Y potato lines

have been genetically engineered to

contain the cry3A gene from Bacillus

thuringiensis subsp. tenebrionis (Btt),

which encodes a protein that is

insecticidal to CPB, and the PVY coat

protein gene (PVYcp), which imparts

resistance to PVY. In addition to the

cry3A gene and the PVYcp gene, these

potato lines contain and express the

nptII selectable marker gene, which is

used in the initial stages of plant

selection. While the two Shepody lines

(SEMT15–02 and SEMT15–15) and the

HiLite line (HLMT15–46) also contain

the aad marker gene, tests indicate that

this gene is not expressed in these

potato plants. The subject potato lines

were developed through the use of the

Agrobacterium tumefaciens

transformation system, and expression

of the introduced genes is controlled in

part by gene sequences derived from the

plant pathogens A. tumefaciens and

figwort mosaic virus.

The subject potato lines have been

considered regulated articles under the

regulations in 7 CFR part 340 because

they contain gene sequences derived

from plant pathogens. These potato

lines have been evaluated in field trials

conducted since 1995 under APHIS

notifications. In the process of

reviewing the notifications for field

trials of the subject potato lines, APHIS

determined that the trials, which were

conducted under conditions of

reproductive and physical containment

or isolation, would not present a risk of

plant pest introduction or

dissemination.

In the Federal Plant Pest Act, as

amended (7 U.S.C. 150aa et seq.), ‘‘plant

pest’’ is defined as ‘‘any living stage of:

Any insects, mites, nematodes, slugs,

snails, protozoa, or other invertebrate

animals, bacteria, fungi, other parasitic

plants or reproductive parts thereof,

viruses, or any organisms similar to or

allied with any of the foregoing, or any

infectious substances, which can

directly or indirectly injure or cause

disease or damage in any plants or parts

thereof, or any processed, manufactured

or other products of plants.’’ APHIS

views this definition very broadly. The

definition covers direct or indirect

injury, disease, or damage not just to

agricultural crops, but also to plants in

general, for example, native species, as

well as to organisms that may be

beneficial to plants, for example,

honeybees, rhizobia, etc.

The U.S. Environmental Protection

Agency (EPA) is responsible for the
38806 Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 / Notices

regulation of pesticides under the

Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA), as amended (7

U.S.C. 136 et seq.). FIFRA requires that

all pesticides, including insecticides, be

registered prior to distribution or sale,

unless exempt by EPA regulation. In

this regard, EPA has issued a

registration to Monsanto for full

commercialization of the plant pesticide

Btt CRY3A delta endotoxin and the

genetic material necessary for its

production in potato. Residue tolerances

for pesticides are established by EPA

under the Federal Food, Drug and

Cosmetic Act (FFDCA), as amended (21

U.S.C. 301 et seq.), and the Food and

Drug Administration (FDA) enforces

tolerances set by EPA under the FFDCA.

In addition to the registration, EPA has

issued exemptions from the requirement

of a tolerance for residues of the subject

plant pesticide CRY3A in potatoes, for

the NPTII protein as a plant pesticide

inert ingredient in all plants, and for the

PVY coat protein in or on all plants and

raw agricultural commodities.

FDA published a statement of policy

on foods derived from new plant

varieties in the Federal Register on May

29, 1992 (57 FR 22984–23005). The FDA

statement of policy includes a

discussion of FDA’s authority for

ensuring food safety under the FFDCA,

and provides guidance to industry on

the scientific considerations associated

with the development of foods derived

from new plant varieties, including

those plants developed through the

techniques of genetic engineering.

Monsanto has completed consultation

with FDA on the subject potato lines.

In accordance with § 340.6(d) of the

regulations, we are publishing this

notice to inform the public that APHIS

will accept written comments regarding

the Petition for Determination of

Nonregulated Status from any interested

person for a period of 60 days from the

date of this notice. The petition and any

comments received are available for

public review, and copies of the petition

may be ordered (see the ADDRESSES

section of this notice).

After the comment period closes,

APHIS will review the data submitted

by the petitioner, all written comments

received during the comment period,

and any other relevant information.

Based on the available information,

APHIS will furnish a response to the

petitioner, either approving the petition

in whole or in part, or denying the

petition. APHIS will then publish a

notice in the Federal Register

announcing the regulatory status of

Monsanto’s NewLeaf Y potato lines

RBMT15–101, SEMT15–02, SEMT15–

15, and HLMT15–46 and the availability

of APHIS’ written decision.

Authority: 7 U.S.C. 150aa–150jj, 151–167,

and 1622n; 31 U.S.C. 9701; 7 CFR 2.22, 2.80,

and 371.2(c).

Done in Washington, DC, this 14th day of

July, 1998.

Craig A. Reed,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 98–19228 Filed 7–17–98; 8:45 am]

BILLING CODE 3410–34–P

DEPARTMENT OF AGRICULTURE

Food and Nutrition Service

Agency Information Collection

Activities: Proposed Collection;

Comment Request—Child Nutrition

Database

AGENCY: Food and Nutrition Service,

USDA.

ACTION: Notice.

SUMMARY: In accordance with the

Paperwork Reduction Act of 1995, this

notice announces the intention of the

Food and Nutrition Service (FNS) to

request voluntary submission of data

including nutrient data from the food

service industry to expand the Child

Nutrition Database in support of the

School Meal Initiatives for Healthy

Children.

DATES: Comments on this notice must be

received by September 18, 1998.

ADDRESSES: Comments are invited on:

(a) Whether the proposed collection of

information is necessary for the proper

performance of the functions of the

agency, including whether the

information will have practical utility;

(b) the accuracy of the agency’s estimate

of the burden of the proposed collection

of information including the validity of

the methodology and assumptions used;

(c) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on those who are to respond, including

through the use of appropriate

automated, electronic, mechanical, or

other technological collection

techniques or other forms of information

technology. All responses to this notice

will be summarized and included in the

request for OMB approval and will

become a matter of public record.

Comments may be sent to: Marion

Hinners, Team Leader, Food Science

and Nutrition Section, Technical

Assistance Branch, Nutrition and

Technical Services Division, Food and

Consumer Service, United States

Department of Agriculture, 3101 Park

Center Drive, Alexandria, VA 22302.

FOR FURTHER INFORMATION CONTACT:

Requests for additional information or

copies of the information collection

instruments and instruction should be

directed to Marion Hinners at (703)

305–2556.

SUPPLEMENTARY INFORMATION:

Title: Data Collection to Expand the

Child Nutrition Database.

OMB Number: Not yet assigned.

(Previously cleared under ARS 0518–

0021).

Expiration Date: Not available.

Type of Request: Reinstatement, with

change, of a previously approved

collection for which approval has

expired.

Abstract: The development of the

Child Nutrition (CN) Database,

previously known as the National

Nutrient Database for Child Nutrition

Programs (NNDCNP), is regulated by the

United States Department of Agriculture

(USDA) School Meal Initiatives for

Healthy Children. This database is

designed to be incorporated in USDA

approved nutrition analysis software

programs and provide an accurate

source of nutrient data, which allows

schools to analyze the meals served to

children and measure the compliance of

the menus to established nutrition goals

and standards specified in 7 CFR 210.10

for the National School Lunch Program

and 7 CFR 220.8 for the School

Breakfast Program. The information

collection for the CN Database was

previously conducted by USDA’s

Agricultural Research Service and will

now be conducted using an outside

contractor. The CN Database needs to be

updated with an extensive database of

brand name or manufactured foods

commonly used in school food service.

The Food and Nutrition Service is

soliciting a contractor to collect this

data from the food industry to expand

the CN Database. The submission of

data from the food industry will be

strictly voluntary, and based on

analytical, calculated, or nutrition facts

label sources.

Estimate of Burden: Public reporting

burden for this collection of information

is estimated to average 2.0 hours per

response.

Respondents: The respondents are the

manufacturers of food products for

school food service.

Estimated Number of Respondents:

100.

Estimated Number of Responses per

Respondent: 30.

Estimated Total Annual Burden on

Respondents: 6,000 hours.