Bejo Zaden BV; Availability of Determination of Nonregulated Status for Genetically Engineered Radicchio Rosso

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.

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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:

[email protected].

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.

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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]

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