University of Saskatchewan; Receipt of Petition for Determination of Nonregulated Status for Flax Genetically Engineered for Tolerance to Soil Residues of Sulfonylurea Herbicides

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

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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]

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