[Federal Register Volume 64, Number 102 (Thursday, May 27, 1999)]
[Notices]
[Pages 28794-28795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13515]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 99-002-2]
University of Saskatchewan; Availability of Determination of
Nonregulated Status for Flax Genetically Engineered for Tolerance to
Soil Residues of Sulfonylurea Herbicides
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public of our determination that the
University of Saskatchewan's flax line designated as CDC Triffid, which
has been genetically engineered for tolerance to soil residues of
sulfonylurea herbicides, is no longer considered a regulated article
under our regulations governing the introduction of certain genetically
engineered organisms. Our determination is based on our evaluation of
data submitted by the University of Saskatchewan in its petition for a
determination of nonregulated status and our 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: May 19, 1999.
ADDRESSES: The determination, an environmental assessment and finding
of no significant impact and 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. James White, Biotechnology and
Biological Analysis, PPQ, APHIS, 4700 River Road Unit 147, Suite 5B05,
Riverdale, MD 20737-1236; (301) 734-
[[Page 28795]]
5940. 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: kay.peterson@usda.gov.
SUPPLEMENTARY INFORMATION:
Background
On December 1, 1998, the Animal and Plant Health Inspection Service
(APHIS) received a petition (APHIS Petition No. 98-335-01p) from the
Crop Development Centre (CDC) of the University of Saskatchewan (CDC/
Saskatchewan) of Saskatchewan, Saskatoon, Canada, seeking a
determination that a flax (Linum usitatissimum L.) line designated as
CDC Triffid, which has been genetically engineered for tolerance to
residues of sulfonylurea herbicides in soil, does not present a plant
pest risk and, therefore, is not a regulated article under APHIS'
regulations in 7 CFR part 340.
On March 4, 1999, APHIS published a notice in the Federal Register
(64 FR 10442-10443, Docket No. 99-002-1) announcing that the CDC/
Saskatchewan 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
the subject flax line and food products derived from it. In the notice,
APHIS solicited written comments from the public as to whether the CDC
Triffid flax line posed a plant pest risk. The comments were to have
been received by APHIS on or before May 3, 1999. APHIS received no
comments on the subject petition during the designated 60-day comment
period.
Analysis
The CDC Triffid flax line has been genetically engineered to
contain a modified acetolactate synthase (als) gene derived from
Arabidopsis thaliana. The als gene encodes a modified acetolactate
snythase enzyme that extends to root tissues the reported natural
ability of flax to withstand sulfonylurea herbicides. The subject flax
line also contains and expresses the nopaline synthase (nos) gene
derived from Agrobacterium tumefaciens and the neomycin
phosphotransferase-II (nptII) gene derived from Escherichia coli. The
nos and nptII genes were used as selectable markers during the plant
transformation process. Expression of the added genes is controlled in
part by gene sequences from the plant pathogen A. tumefaciens, and the
A. tumefaciens method was used to transfer the added genes into the
parental Norlin commercial flax variety.
The CDC Triffid flax line has been considered a regulated article
under APHIS' regulations in 7 CFR part 340 because it contains gene
sequences derived from a plant pathogen. However, evaluation of data
from field tests and site monitoring conducted in Canada indicates that
there were no deleterious effects on plants, nontarget organisms, or
the environment as a result of the environmental release of the CDC
Triffid flax line.
Determination
Based on its analysis of the data submitted by CDC/Saskatchewan and
a review of other scientific data and field tests of the subject flax
line, APHIS has determined that the CDC Triffid flax line: (1) Exhibits
no plant pathogenic properties; (2) is no more likely to become a weed
than flax varieties developed by traditional plant breeding; (3) is
unlikely to increase the weediness potential for any sexually
compatible cultivated or wild species; (4) will not harm nontarget
organisms, including threatened or endangered species or organisms that
are recognized as beneficial to the agricultural ecosystem; and (5)
will not cause damage to raw or processed agricultural commodities.
Therefore, APHIS has concluded that the subject flax line and any
progeny derived from hybrid crosses with other flax varieties will be
as safe to grow as flax in traditional breeding programs that is not
subject to regulation under 7 CFR part 340.
The effect of this determination is that CDC/Saskatchewan's CDC
Triffid flax line is no longer considered a regulated article under
APHIS' regulations in 7 CFR part 340. Therefore, the requirements
pertaining to regulated articles under those regulations no longer
apply to the subject flax line or its progeny. However, importation of
the CDC Triffid flax line 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 CDC/Saskatchewan's CDC Triffid flax line and lines
developed from it 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 21st day of May 1999.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-13515 Filed 5-26-99; 8:45 am]
BILLING CODE 3410-34-P
