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

18718

Vol. 61, No. 83

Monday, April 29, 1996

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 96–019–1]

AgrEvo USA Company; Receipt of

Petition for Determination of

Nonregulated Status for Soybeans

Genetically Engineered for Glufosinate

Tolerance

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 AgrEvo USA Company

seeking a determination of nonregulated

status for certain soybeans genetically

engineered for tolerance to the herbicide

glufosinate. 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

soybeans present a plant pest risk.

DATES: Written comments must be

received on or before June 28, 1996.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 96–019–1, 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. 96–019–1. 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.

FOR FURTHER INFORMATION CONTACT: Dr.

Sivramiah Shantharam, Biotechnology

Permits, BBEP, APHIS, Suite 5B05, 4700

River Road Unit 147, Riverdale, MD

20737–1237; (301) 734–7612. To obtain

a copy of the petition, contact Ms. Kay

Peterson at (301) 734–7612; 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 March 8, 1996, APHIS received a

petition (APHIS Petition No. 96–068–

01p) from AgrEvo USA Company

(AgrEvo) of Wilmington, DE, requesting

a determination of nonregulated status

under 7 CFR part 340 for soybeans

designated as Glufosinate Resistant

Soybean (GRS) Transformation Events

W62, W98, A2704–12, A2704–21, and

A5547–35 that have been genetically

engineered for resistance, or tolerance,

to the herbicide glufosinate. The AgrEvo

petition states that the subject GRS

transformation events should not be

regulated by APHIS because they do not

present a plant pest risk.

As described in the petition, GRS

transformation events W62 and W98

have been genetically engineered to

contain the bar gene derived from

Streptomyces hygroscopicus and the gus

gene derived from Escherichia coli. The

bar gene encodes the enzyme

phosphinothricin-N-acetyltransferase

(PAT), which confers tolerance to

glufosinate, and the gus gene encodes

the enzyme Β-glucuronidase, which is

useful as a selectable marker in the

transformation process. Expression of

these added genes is controlled in part

by gene sequences from the plant pests

Agrobacterium tumefaciens, alfalfa

mosaic virus (AMV), and cauliflower

mosaic virus (CaMV). GRS

transformation events A2704–12,

A2704–21, and A5547–35 contain a

synthetic version of the pat gene

derived from Streptomyces

viridochromogenes, which encodes the

PAT enzyme and confers tolerance to

glufosinate. Expression of the synthetic

pat gene is controlled by a 35S promoter

and terminator derived from CaMV. The

particle acceleration method was used

to transfer the added genes into the

parental soybean cultivars.

GRS transformation events W62, W98,

A2704–12, A2704–21, and A5547–35

have been considered regulated articles

under the regulations in 7 CFR part 340

because they contain gene sequences

from the plant pathogens mentioned

above. GRS transformation events W62

and W98 have been field tested since

1990 under APHIS permits or

notifications, and GRS transformation

events A2704–12, A2704–21, and

A5547–35 were field tested in 1995

under APHIS notifications. In the

process of reviewing the applications for

field trials of the subject GRS

transformation events, 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
Federal Register / Vol. 61, No. 83 / Monday, April 29, 1996 / Notices 18719

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 herbicides, be

registered prior to distribution or sale,

unless exempt by EPA regulation. In

cases in which genetically modified

plants allow for a new use of an

herbicide or involve a different use

pattern for the herbicide, EPA must

approve the new or different use. When

the use of the herbicide on the

genetically modified plant would result

in an increase in the residues of the

herbicide in a food or feed crop for

which the herbicide is currently

registered, or in new residues in a crop

for which the herbicide is not currently

registered, establishment of a new

tolerance or a revision of the existing

tolerance would be required. Residue

tolerances for pesticides are established

by EPA under the Federal Food, Drug

and Cosmetic Act (FFDCA) (21 U.S.C.

201 et seq.), and the Food and Drug

Administration (FDA) enforces

tolerances set by EPA under the FFDCA.

Currently, glufosinate is not registered

for use on soybeans.

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.

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

AgrEvo’s GRS transformation events

W62, W98, A2704–12, A2704–21, and

A5547–35 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 23rd day of

April 1996.

Lonnie J. King,

Administrator, Animal and Plant Health

Inspection Service.

[FR Doc. 96–10462 Filed 4–26–96; 8:45 am]

BILLING CODE 3410–34–P

Animal and Plant Health Inspection

Service, USDA

[Docket No. 92–110–5]

Veterinary Services Draft

Programmatic Environmental Impact

Statement

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice of extension of comment

period.

SUMMARY: We are extending the

comment period for our notice that

advised the public that the Animal and

Plant Health Inspection Service has

prepared a draft programmatic

environmental impact statement for the

Veterinary Services Program, which is

responsible for the protection of the

Nation’s livestock and poultry. This

extension will provide interested

persons with additional time to prepare

and submit comments on the draft

programmatic environmental impact

statement.

DATES: Consideration will be given only

to comments on Docket No. 92–110–4

that are received on or before June 25,

1996.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 92–110–4, 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. 92–110–4. 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 to

inspect comments are requested to call

ahead on (202) 690–2817 to facilitate

entry into the comment reading room.

Interested persons may obtain a copy

of the draft environmental impact

statement by writing to the addresses

listed below under FOR FURTHER

INFORMATION CONTACT. The draft

environmental impact statement may

also be viewed on the Internet at

www.aphis.usda.gov/bbep.ead/

vsdocs.html.

FOR FURTHER INFORMATION CONTACT: Ms.

Nancy Sweeney, Project Leader,

Environmental Analysis and

Documentation, BBEP, APHIS, Suite

5B05, 4700 River Road Unit 149,

Riverdale, MD 20737–1237, (301) 734–

8565; or e-mail:

nsweeney@aphis.usda.gov; or Dr.

William E. Ketter, Chief Staff

Veterinarian, Program Evaluations and

Planning Staff, VS, APHIS, Suite 3B08,

4700 River Road Unit 33, Riverdale, MD

20737–1231, (301) 734–4357; or e-mail:

wketter@aphis.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

On March 29, 1996, we published in

the Federal Register (61 FR 14046–

14047, Docket No. 92–110–4) a notice

advising the public that the Animal and

Plant Health Inspection Service has

prepared a draft programmatic

environmental impact statement for the

Veterinary Services Program, which is

responsible for the protection of the

Nation’s livestock and poultry. The

notice also asked for public comment on

the draft programmatic environmental

impact statement.

Comments on the draft programmatic

environmental impact statement were

required to be received on or before May

28, 1996. We are extending the

comment period on Docket No. 92–110–

4 for an additional 30 days. This action

will allow interested persons additional

time to prepare and submit comments.

Done in Washington, DC, this 23rd day of

April 1996.

Lonnie J. King,

Administrator, Animal and Plant Health

Inspection Service.

[FR Doc. 96–10460 Filed 4–26–96; 8:45 am]

BILLING CODE 3410–34–P

Food Safety and Inspection Service

[Docket No. 96–015N]

Nominations for Membership on the

National Advisory Committee on

Microbiological Criteria for Foods

The National Advisory Committee on

Microbiological Criteria for Foods

(NACMCF) is soliciting nominations for

membership.