[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: [email protected].

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