AgrEvo USA Co.; Receipt of Petition for Determination of Nonregulated Status for Canola Genetically Engineered for Glufosinate Tolerance

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 97-091-1]

AgrEvo USA Co.; Receipt of Petition for Determination of

Nonregulated Status for Canola Genetically Engineered for Glufosinate

Tolerance

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 AgrEvo USA Company

seeking a determination of nonregulated status for canola designated as

Transformation Event T45, which has been genetically engineered for

tolerance to the herbicide glufosinate. 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 canola presents a plant pest risk.

DATES: Written comments must be received on or before December 1, 1997.

ADDRESSES: Please send an original and three copies of your comments to

Docket No. 97-091-1, 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. 97-091-1. 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 Lackey, Biotechnology

Evaluation, BSS, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147,

Riverdale, MD 20737-1236; (301) 734-7612. To obtain a copy of the

petition, contact Ms. Kay Peterson at (301) 734-4885; e-mail:

[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 July 24, 1997, APHIS received a petition (APHIS Petition No. 97-

205-01p) from AgrEvo USA Company (AgrEvo) of Wilmington, DE, requesting

a determination of nonregulated status under 7 CFR part 340 for canola

(Brassica napus L.) designated as Transformation Event T45 (event T45),

which has been genetically engineered for tolerance to the herbicide

glufosinate. The AgrEvo petition states that the subject canola should

not be regulated by APHIS because it does not present a plant pest

risk.

As described in the petition, event T45 canola has been genetically

engineered to contain the pat gene derived from Streptomyces

viridochromogenes. The pat gene encodes the enzyme phosphinothricin-N-

acetyltransferase (PAT), which confers tolerance to the herbicide

glufosinate. Expression of the pat gene is controlled by the 35S

promoter and terminator derived from the plant pathogen cauliflower

mosaic virus. The Agrobacterium tumefaciens method was used to transfer

the added genes into the parental cultivar B. napus var. AC EXCEL.

Event T45 canola has been considered a regulated article under the

regulations in 7 CFR part 340 because it contains gene sequences from

plant pests. The subject canola has been field tested in Canada since

1995, and in the U.S. since 1996 under APHIS permits. In the process of

reviewing the permit applications for field trials of this canola,

APHIS determined that the vectors and other elements were disarmed and

that the trials, which were conducted under conditions of reproductive

and physical containment or isolation, would not present a risk of

plant pest introduction or dissemination. Event T45 canola has been

approved for commercial sale in Canada.

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.

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. AgrEvo

has begun consultation with FDA on the subject canola.

[[Page 51082]]

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 (see the ADDRESSES section of this notice).

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 AgrEvo's event T45 canola, 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 24th day of September 1997.

Terry L. Medley,

Aministrator, Animal and Plant Health Inspection Service.

[FR Doc. 97-25858 Filed 9-29-97; 8:45 am]

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