[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.Peterson@usda.gov.
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
