[Federal Register Volume 62, Number 224 (Thursday, November 20, 1997)]
[Notices]
[Pages 61960-61961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30507]


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 Notices
                                                 Federal Register
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 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.
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  Federal Register / Vol. 62, No. 224 / Thursday, November 20, 1997 / 
Notices  

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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.

[[Page 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]
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