[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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