[Federal Register Volume 64, Number 42 (Thursday, March 4, 1999)]
[Notices]
[Pages 10442-10443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5360]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 99-002-1]


University of Saskatchewan; Receipt of Petition for 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.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has received a petition from the University of 
Saskatchewan seeking a determination of nonregulated status for a flax 
line designated as CDC Triffid, which has been genetically engineered 
for tolerance to residues of sulfonylurea herbicides in soil. The 
petition has been submitted in accordance with our regulations 
concerning the introduction of certain genetically engineered organisms 
and products. In accordance with those regulations, we are soliciting 
public comments on whether this flax line presents a plant pest risk.

DATES: Written comments must be received on or before May 3, 1999.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 99-002-1, Regulatory Analysis and Development, PPD, APHIS, 
Suite 3C03, 4700 River Road, Unit 118, Riverdale, MD 20737-1238. Please 
state that your comments refer to Docket No. 99-002-1. A copy of the 
petition and any comments received 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 access to that room to inspect the petition 
or comments 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, Suite 5B05, 4700 River Road, Unit 147, 
Riverdale, MD 20737-1236; (301) 734-5940. To obtain a copy of the 
petition, contact Ms. Kay Peterson at (301) 734-4885; e-mail: 
Kay.P[email protected].

SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340, 
``Introduction of Organisms and Products Altered or Produced Through 
Genetic Engineering Which Are Plant Pests or Which There Is Reason to 
Believe Are Plant Pests,'' regulate, among other things, the 
introduction (importation, interstate movement, or release into the 
environment) of organisms and products altered or produced through 
genetic engineering that are plant pests or that there is reason to 
believe are plant pests. Such genetically engineered organisms and 
products are considered ``regulated articles.''
    The regulations in Sec. 340.6(a) provide that any person may submit 
a petition to the Animal and Plant Health Inspection Service (APHIS) 
seeking a determination that an article should not be regulated under 7 
CFR part 340. Paragraphs (b) and (c) of Sec. 340.6 describe the form 
that a petition for determination of nonregulated status must take and 
the information that must be included in the petition.
    On December 1, 1998, 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, 
requesting a determination of nonregulated status under 7 CFR part 340 
for a flax (Linum usitatissimum L.) line designated as CDC Triffid, 
which has been genetically engineered for tolerance to residues of 
sulfonylurea herbicides in soil. The CDC Triffid flax line was 
developed for use as a rotational crop alternative with cereals such as 
wheat and barley on soils containing residues of sulfonylurea 
herbicides. The CDC/Saskatchewan petition states that the subject flax 
line should not be regulated by APHIS because it does not present a 
plant pest risk.
    As described in the petition, 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 synthase 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 Escherchia coli. The 
nos and nptII genes are used as selectable markers during the plant

[[Page 10443]]

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 the regulations in 7 CFR part 340 because it contains gene 
sequences from a plant pathogen. The subject flax line was extensively 
field tested under confined conditions in Canada in Saskatchewan, 
Manitoba, and Alberta between 1989 and 1995, and grown under unconfined 
conditions in Canada since 1996. Field test data and site monitoring 
indicate no risk of plant pest introduction or dissemination and no 
negative environmental impacts from the field testing or unconfined 
release of this flax line. The CDC Triffid flax line was cleared for 
variety registration, unrestricted environmental release, and use as 
animal feed in 1996 by Agriculture and Agri-Food Canada, and Health 
Canada granted human food approval in 1998.
    In the Federal Plant Pest Act, as amended (7 U.S.C. 150aa et seq.), 
``plant pest'' is defined as ``any living stage of: Any insects, mites, 
nematodes, slugs, snails, protozoa, or other invertebrate animals, 
bacteria, fungi, other parasitic plants or reproductive parts thereof, 
viruses, or any organisms similar to or allied with any of the 
foregoing, or any infectious substances, which can directly or 
indirectly injure or cause disease or damage in any plants or parts 
thereof, or any processed, manufactured or other products of plants.'' 
APHIS views this definition very broadly. The definition covers direct 
or indirect injury, disease, or damage not just to agricultural crops, 
but also to plants in general, for example, native species, as well as 
to organisms that may be beneficial to plants, for example, honeybees, 
rhizobia, etc.
    The U.S. Environmental Protection Agency (EPA) is responsible for 
the regulation of pesticides under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA 
requires that all pesticides, including herbicides, be registered prior 
to distribution or sale, unless exempt by EPA regulation. In cases in 
which genetically modified plants allow for a new use of an herbicide 
or involve a different use pattern for the herbicide, EPA must approve 
the new or different use. When the use of the herbicide on the 
genetically modified plant would result in an increase in the residues 
of the herbicide in a food or feed crop for which the herbicide is 
currently registered, or in new residues in a crop for which the 
herbicide is not currently registered, establishment of a new tolerance 
or a revision of the existing tolerance would be required. Residue 
tolerances for pesticides are established by EPA under the Federal 
Food, Drug and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 et 
seq.), and the Food and Drug Administration (FDA) enforces tolerances 
set by EPA under the FFDCA. Sulfonylurea herbicides are not registered 
for use on flax in either the United States or Canada.
    FDA published a statement of policy on foods derived from new plant 
varieties in the Federal Register on May 29, 1992 (57 FR 22984-23005). 
The FDA statement of policy includes a discussion of FDA's authority 
for ensuring food safety under the FFDCA, and provides guidance to 
industry on the scientific considerations associated with the 
development of foods derived from new plant varieties, including those 
plants developed through the techniques of genetic engineering. CDC/
Saskatchewan completed consultation with FDA in 1998 on the subject 
flax line.
    In accordance with Sec. 340.6(d) of the regulations, we are 
publishing this notice to inform the public that APHIS will accept 
written comments regarding the Petition for Determination of 
Nonregulated Status from any interested person for a period of 60 days 
from the date of this notice. The petition and any comments received 
are available for public review, and copies of the petition may be 
ordered from the individual listed under FOR FURTHER INFORMATION 
CONTACT.
    After the comment period closes, APHIS will review the data 
submitted by the petitioner, all written comments received during the 
comment period, and any other relevant information. Based on the 
available information, APHIS will furnish a response to the petitioner, 
either approving the petition in whole or in part, or denying the 
petition. APHIS will then publish a notice in the Federal Register 
announcing the regulatory status of the CDC/Saskatchewan CDC Triffid 
flax line and the availability of APHIS' written decision.

    Authority: 7 U.S.C. 150aa-150jj, 151-167, and 1622n; 31 U.S.C. 
9701; 7 CFR 2.22, 2.80, and 371.2(c).

    Done in Washington, DC, this 26th day of February 1999.
Joan M. Arnoldi,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-5360 Filed 3-3-99; 8:45 am]
BILLING CODE 3410-34-P