63312 Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Notices

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 97–114–1]

Monsanto Co.; Receipt of Petition for

Determination of Nonregulated Status

for Genetically Engineered Tomato

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 a tomato line designated as

5345, which has been genetically

engineered for resistance to certain

lepidopteran insect pests. 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 this tomato line presents a

plant pest risk.

DATES: Written comments must be

received on or before January 27, 1998.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 97–114–1, 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. 97–114–1. 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.

Sivramiah Shantharam, Biotechnology

Evaluation, BSS, PPQ, APHIS, Suite

5B05, 4700 River Road Unit 147,

Riverdale, MD 20737–1236; (301) 734–

4882. To obtain a copy of the petition,

contact Ms. Kay Peterson at (301) 734–

4885; e-mail:

mkpeterson@aphis.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 October 14, 1997, APHIS received

a petition (APHIS Petition No. 97–287–

01p) from Monsanto Company

(Monsanto) of St. Louis, MO, requesting

a determination of nonregulated status

under 7 CFR part 340 for a genetically

engineered, insect-resistant tomato line

designated as 5345. The petition states

that the subject tomato line should not

be regulated by APHIS because it does

not present a plant pest risk.

As described in the petition, tomato

line 5345 has been genetically

engineered to express a CryIA(c) insect

control protein derived from the

common soil bacterium Bacillus

thuringiensis subsp. kurstaki HD–73

(Btk). The petitioner states that

expression of the Btk delta-endotoxin

protein protects the subject tomato line

from damage caused by certain

lepidopteran insect pests. Tomato line

5345 also expresses the NPTII protein

which serves as a selectable marker in

the plant transformation process. While

the subject tomato line contains the aad

gene, tests indicate that the AAD

protein, which serves as a selectable

marker in the laboratory prior to plant

transformation, is not expressed in the

plant. The added genes were introduced

into the UC82B parental tomato plants

by the Agrobacterium tumefaciens

transformation system, and their

expression is controlled in part by gene

sequences derived from the plant

pathogens cauliflower mosaic virus and

A. tumefaciens.

The subject tomato line is currently

considered a regulated article under the

regulations in 7 CFR part 340 because it

contains gene sequences derived from

plant pathogenic sources. Tomato line

5345 has been evaluated in field trials

conducted since 1994 under APHIS

notifications. In the process of

reviewing the notifications for field

trials of this tomato line, APHIS

determined that the vectors and other

elements were disarmed and 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

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

cases in which the genetically modified

plant allows for a new or different use

pattern for a pesticide, EPA must

approve the new or different use.

Residue tolerances for pesticides are

established by the 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 the EPA under the

FFDCA. The EPA has granted

exemptions from the requirement of a

tolerance for residues of the CryIA(c)

and NPTII proteins and the genetic

material necessary for their production

in all plants.

The 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 the 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.
Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Notices 63313

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 insect-resistant tomato line

5345 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 20th day of

November 1997.

Craig A. Reed,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 97–31222 Filed 11–26–97; 8:45 am]

BILLING CODE 3410–34–P

COMMITTEE FOR PURCHASE FROM

PEOPLE WHO ARE BLIND OR

SEVERELY DISABLED

Procurement List Additions

AGENCY: Committee for Purchase From

People Who Are Blind or Severely

Disabled

ACTION: Additions to the Procurement

List.

SUMMARY: This action adds to the

Procurement List services to be

furnished by nonprofit agencies

employing persons who are blind or

have other severe disabilities.

EFFECTIVE DATE: December 29, 1997.

ADDRESSES: Committee for Purchase

From People Who Are Blind or Severely

Disabled, Crystal Gateway 3, Suite 310,

1215 Jefferson Davis Highway,

Arlington, Virginia 22202–4302.

FOR FURTHER INFORMATION CONTACT:

Beverly Milkman (703) 603–7740.

SUPPLEMENTARY INFORMATION: On

October 10, 1997, the Committee for

Purchase From People Who Are Blind

or Severely Disabled published notice

(62 FR 52969) of proposed additions to

the Procurement List.

After consideration of the material

presented to it concerning capability of

qualified nonprofit agencies to provide

the services and impact of the additions

on the current or most recent

contractors, the Committee has

determined that the services listed

below are suitable for procurement by

the Federal Government under 41 U.S.C.

46–48c and 41 CFR 51–2.4.

I certify that the following action will

not have a significant impact on a

substantial number of small entities.

The major factors considered for this

certification were:

1. The action will not result in any

additional reporting, recordkeeping or

other compliance requirements for small

entities other than the small

organizations that will furnish the

services to the Government.

2. The action will not have a severe

economic impact on current contractors

for the services.

3. The action will result in

authorizing small entities to furnish the

services to the Government.

4. There are no known regulatory

alternatives which would accomplish

the objectives of the Javits-WagnerO’Day Act (41 U.S.C. 46–48c) in

connection with the services proposed

for addition to the Procurement List.

Accordingly, the following services

are hereby added to the Procurement

List:

Janitorial/Custodial, Keene USARC, 682

Main Street, Keene, New Hampshire.

Janitorial/Custodial, Grenier Field

USARC, Manchester, New Hampshire.

Janitorial/Custodial, Craft Bros. USARC,

11 St. Anselm’s Drive, Manchester,

New Hampshire.

Janitorial/Custodial, Paul A. Doble

USARC, 125 Cottage Street,

Portsmouth, New Hampshire.

Janitorial/Custodial, Raymond Bisson

USARC, 70 Rochester Hill Road,

Rochester, New Hampshire.

Janitorial/Custodial, Rainbow Bridge

U.S. Plaza, Niagara Falls, New York.

Switchboard Operation, Veterans Affairs

Medical Center, 423 East 23rd Street,

New York, New York.

This action does not affect current

contracts awarded prior to the effective

date of this addition or options that may

be exercised under those contracts.

Beverly L. Milkman,

Executive Director.

[FR Doc. 97–31379 Filed 11–26–97; 8:45 am]

BILLING CODE 6353–01–P

COMMITTEE FOR PURCHASE FROM

PEOPLE WHO ARE BLIND OR

SEVERELY DISABLED

Procurement List; Proposed Additions

AGENCY: Committee for Purchase From

People Who Are Blind or Severely

Disabled.

ACTION: Proposed Additions to

Procurement List.

SUMMARY: The Committee has received

proposals to add to the Procurement List

commodities and services to be

furnished by nonprofit agencies

employing persons who are blind or

have other severe disabilities.

COMMENTS MUST BE RECEIVED ON OR

BEFORE: December 29, 1997.

ADDRESSES: Committee for Purchase

From People Who Are Blind or Severely

Disabled, Crystal Gateway 3, Suite 310,

1215 Jefferson Davis Highway,

Arlington, Virginia 22202–4302.

FOR FURTHER INFORMATION CONTACT:

Beverly Milkman (703) 603–7740.

SUPPLEMENTARY INFORMATION: This

notice is published pursuant to 41

U.S.C. 47(a)(2) and 41 CFR 51–2.3. Its

purpose is to provide interested persons

an opportunity to submit comments on

the possible impact of the proposed

actions.

If the Committee approves the

proposed additions, all entities of the

Federal Government (except as

otherwise indicated) will be required to

procure the commodities and services

listed below from nonprofit agencies

employing persons who are blind or

have other severe disabilities.

I certify that the following action will

not have a significant impact on a

substantial number of small entities.

The major factors considered for this

certification were:

1. The action will not result in any

additional reporting, recordkeeping or

other compliance requirements for small

entities other than the small

organizations that will furnish the

commodities and services to the

Government.

2. The action will result in

authorizing small entities to furnish the

commodities and services to the

Government.

3. There are no known regulatory

alternatives which would accomplish

the objectives of the Javits-WagnerO’Day Act (41 U.S.C. 46–48c) in

connection with the commodities and

services proposed for addition to the

Procurement List. Comments on this

certification are invited. Commenters

should identify the statement(s)

underlying the certification on which