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

61960

Vol. 62, No. 224

Thursday, November 20, 1997

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 97–067–2]

Bejo Zaden BV; Availability of

Determination of Nonregulated Status

for Genetically Engineered Radicchio

Rosso

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice.

SUMMARY: We are advising the public of

our determination that Bejo Zaden BV’s

Radicchio rosso lines designated as

RM3–3, RM3–4, and RM3–6, which

have been genetically engineered for

male sterility and tolerance to the

herbicide glufosinate as a marker, are no

longer considered regulated articles

under our regulations governing the

introduction of certain genetically

engineered organisms. Our

determination is based on our

evaluation of data submitted by Bejo

Zaden BV in its petition for a

determination of nonregulated status

and an analysis of other scientific data.

This notice also announces the

availability of our written determination

document and its associated

environmental assessment and finding

of no significant impact.

EFFECTIVE DATE: November 7, 1997.

ADDRESSES: The determination, an

environmental assessment and finding

of no significant impact, the petition,

and any written comments received

regarding the petition 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 those documents are asked to

call in advance of visiting at (202) 690–

2817 to facilitate entry into the reading

room.

FOR FURTHER INFORMATION CONTACT: Dr.

Subhash Gupta, Biotechnology

Evaluation, BSS, PPQ, APHIS, 4700

River Road Unit 147, Riverdale, MD

20737–1236; (301) 734–8761. To obtain

a copy of the determination or the

environmental assessment and finding

of no significant impact, contact Ms.

Kay Peterson at (301) 734–4885; e-mail:

mkpeterson@aphis.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

On May 28, 1997, the Animal and

Plant Health Inspection Service (APHIS)

received a petition (APHIS Petition No.

97–148–01p) from Bejo Zaden BV (Bejo)

of Warmenhuizen, The Netherlands,

seeking a determination that Radicchio

rosso (red-hearted chicory) lines

designated as RM3–3, RM3–4, and

RM3–6, which have been genetically

engineered for male sterility and

tolerance to the herbicide glufosinate as

a marker, do not present a plant pest

risk and, therefore, are not regulated

articles under APHIS’ regulations in 7

CFR part 340.

On August 27, 1997, APHIS published

a notice in the Federal Register (62 FR

45387–45388, Docket No. 97–067–1)

announcing that the Bejo petition had

been received and was available for

public review. The notice also discussed

the role of APHIS, the Environmental

Protection Agency, and the Food and

Drug Administration in regulating

Radicchio rosso lines RM3–3, RM3–4,

and RM3–6 and food products derived

from them. In the notice, APHIS

solicited written comments from the

public as to whether these Radicchio

rosso lines posed a plant pest risk. The

comments were to have been received

by APHIS on or before October 27, 1997.

APHIS received no comments on the

subject petition during the designated

60-day comment period.

Analysis

Radicchio rosso (Chichorium intybus

L.) lines RM3–3, RM3–4, and RM3–6

have been genetically engineered with a

barnase gene from Bacillus

amyloliquefaciens encoding a

ribonuclease which inhibits pollen

formation and results in male sterility of

the transformed plants. The subject

Radicchio rosso lines also contain the

nptII selectable marker gene and the bar

gene isolated from the bacterium

Streptomyces hygroscopicus. The bar

gene encodes a phosphinothricin

acetyltransferase (PAT) enzyme, which,

when introduced into a plant cell,

inactivates glufosinate. Linkage of the

barnase gene, which induces male

sterility, with the bar gene, a glufosinate

tolerance gene used as a marker, enables

identification of the male sterile line for

the production of pure hybrid seed. The

subject Radicchio rosso lines were

transformed by the Agrobacterium

tumefaciens method, and expression of

the introduced genes is controlled in

part by gene sequences derived from the

plant pathogen A. tumefaciens.

Radicchio rosso lines RM3–3, RM3–4,

and RM3–6 have been considered

regulated articles under APHIS’

regulations in 7 CFR part 340 because

they contain regulatory gene sequences

derived from a plant pathogen.

However, evaluation of field data

reports from field tests of the subject

Radicchio rosso lines conducted in

Europe since 1993 and under an APHIS

permit since 1995, indicates that there

were no deleterious effects on plants,

nontarget organisms, or the environment

as a result of the environmental release

of these Radicchio rosso lines.

Determination

Based on its analysis of the data

submitted by Bejo and a review of other

scientific data and field tests of the

subject Radicchio rosso lines, APHIS

has determined that Radicchio rosso

lines RM3–3, RM3–4, and RM3–6: (1)

Exhibit no plant pathogenic properties;

(2) are no more likely to become a weed

than Radicchio rosso lines developed by

traditional breeding techniques; (3) are

unlikely to increase the weediness

potential for any other cultivated or

wild species with which they can

interbreed; (4) will not cause damage to

raw or processed agricultural

commodities; and (5) will not harm

threatened or endangered species or

other organisms, such as bees, that are

beneficial to agriculture. Therefore,

APHIS has concluded that Radicchio

rosso lines RM3–3, RM3–4, and RM3–6

and any progeny derived from hybrid

crosses with other nontransformed

Radicchio rosso varieties will not

exhibit new plant pest properties, i.e.,

properties substantially different from

any observed for the subject Radicchio

rosso lines already field tested, or those

observed for Radicchio rosso in

traditional breeding programs.
Federal Register / Vol. 62, No. 224 / Thursday, November 20, 1997 / Notices 61961

The effect of this determination is that

Bejo’s Radicchio rosso lines designated

as RM3–3, RM3–4, and RM3–6 are no

longer considered regulated articles

under APHIS’ regulations in 7 CFR part

340. Therefore, the requirements

pertaining to regulated articles under

those regulations no longer apply to the

field testing, importation, or interstate

movement of Bejo’s Radicchio rosso

lines RM3–3, RM3–4, and RM3–6 or

their progeny. However, the importation

of the subject Radicchio rosso lines or

seeds capable of propagation are still

subject to the restrictions found in

APHIS’ foreign quarantine notices in 7

CFR part 319.

National Environmental Policy Act

An environmental assessment (EA)

has been prepared to examine the

potential environmental impacts

associated with this determination. The

EA was prepared in accordance with: (1)

The National Environmental Policy Act

of 1969 (NEPA), as amended (42 U.S.C.

4321 et seq.), (2) regulations of the

Council on Environmental Quality for

implementing the procedural provisions

of NEPA (40 CFR parts 1500–1508), (3)

USDA regulations implementing NEPA

(7 CFR part 1b), and (4) APHIS’ NEPA

Implementing Procedures (7 CFR part

372). Based on that EA, APHIS has

reached a finding of no significant

impact (FONSI) with regard to its

determination that Radicchio rosso lines

RM3–3, RM3–4, and RM3–6 and lines

developed from them are no longer

regulated articles under its regulations

in 7 CFR part 340. Copies of the EA and

the FONSI are available upon request

from the individual listed under FOR

FURTHER INFORMATION CONTACT.

Done in Washington, DC, this 14th day of

November 1997.

Craig A. Reed,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 97–30507 Filed 11–19–97; 8:45 am]

BILLING CODE 3410–34–P

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 97–094–1]

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 leaf

roll virus. 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 January 20, 1998.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 97–094–1, 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. 97–094–1. 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.

James White, Biotechnology Evaluation,

BSS, PPQ, APHIS, Suite 5B05, 4700

River Road Unit 147, Riverdale, MD

20737–1236; (301) 734–5940. 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 July 23, 1997, APHIS received a

petition (APHIS Petition No. 97–204–

01p) from Monsanto Company

(Monsanto) of St. Louis, MO, requesting

a determination of nonregulated status

under 7 CFR part 340 for seven

NewLeaf Plus Russet Burbank potato

lines (RBMT21–129, RBMT21–152,

RBMT21–350, RBMT22–82, RBMT22–

186, RBMT22–238, RBMT22–262),

which have genetically engineered for

resistance to the Colorado potato beetle

(CPB) and potato leaf roll virus (PLRV).

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 seven

of the subject Russet Burbank potato

lines have been genetically engineered

to contain the cryIIIA gene from Bacillus

thuringiensis subsp. tenebrionis (Btt),

which encodes an insecticidal protein

that is effective against CPB, and the

PLRV replicase gene (PLRVrep), which

imparts resistance to PLRV. In addition

to the cryIIIA gene and the PLRVrep

gene, these potato lines contain either

the nptII selectable marker gene

(RBMT21–129, RBMT21–152, and

RBMT21–350) or the CP4 EPSPS

selectable marker gene (RBMT22–82,

RBMT22–186, RBMT22–238, and

RBMT22–262). 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 pests 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 pests. These potato lines

have been evaluated in field trials

conducted since 1994 under APHIS

permits. In the process of reviewing the

applications for field trials of the subject

potato lines, 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