AgrEvo USA Co.; Availability of Determination of Nonregulated Status for Canola Genetically Engineered for Glufosinate Herbicide Tolerance

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 97-091-2]

AgrEvo USA Co.; Availability of Determination of Nonregulated

Status for Canola Genetically Engineered for Glufosinate Herbicide

Tolerance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: We are advising the public of our determination that AgrEvo

USA Company's canola designated as Transformation Event T45, which has

been genetically engineered for tolerance to the herbicide glufosinate,

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

AgrEvo USA Company in its petition for a determination of nonregulated

status and an 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: January 29, 1998.

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 Lackey, Biotechnology

Evaluation, BSS, PPQ, APHIS, 4700 River Road Unit 147, Riverdale, MD

20737-1236; (301) 734-6748. 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 July 24, 1997, the Animal and Plant Health Inspection Service

(APHIS) received a petition (APHIS Petition No. 97-205-01p) from AgrEvo

USA Company (AgrEvo) of Wilmington, DE, seeking a determination that

canola (Brassica napus L.) designated as Transformation Event T45

(event T45), which has been genetically engineered for tolerance to the

herbicide glufosinate, does not present a plant pest risk and,

therefore, is not a regulated article under APHIS' regulations in 7 CFR

part 340.

On September 30, 1997, APHIS published a notice in the Federal

Register (62 FR 51081-51082, Docket No. 97-091-1) announcing that the

AgrEvo 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 canola and food products derived from it. In the notice,

APHIS solicited written comments from the public as to whether this

canola posed a plant pest risk. The comments were to have been received

by APHIS on

[[Page 6704]]

or before December 1, 1997. APHIS received no comments on the subject

petition during the designated 60-day comment period.

Analysis

Event T45 canola has been genetically engineered to contain a 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 a 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.

The subject canola has been considered a regulated article under

APHIS' regulations in 7 CFR part 340 because it contains gene sequences

derived from plant pathogens. However, evaluation of field data reports

from field tests of this canola conducted under APHIS permits since

1996 indicates that there were no deleterious effects on plants,

nontarget organisms, or the environment as a result of the

environmental release of event T45 canola.

Determination

Based on its analysis of the data submitted by AgrEvo, and a review

of other scientific data and field tests of the subject canola, APHIS

has determined that event T45 canola: (1) Exhibits no plant pathogenic

properties; (2) is no more likely to become a weed than canola

developed by traditional breeding techniques; (3) is unlikely to

increase the weediness potential for any other cultivated or wild

species with which it can interbreed; (4) will not cause damage to raw

or processed agricultural commodities; and (5) will not harm threatened

or endangered species or other organisms, such as bees, that are

beneficial to agriculture. Therefore, APHIS has concluded that the

subject canola and any progeny derived from hybrid crosses with other

nontransformed canola varieties will be as safe to grow as canola in

traditional breeding programs that are not subject to regulation under

7 CFR part 340.

The effect of this determination is that AgrEvo's event T45 canola

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 canola

of its progeny. However, importation of the subject canola 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 AgrEvo's event T45 canola 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 4th day of January 1998.

Terry L. Medley,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 98-3312 Filed 2-9-98; 8:45 am]

BILLING CODE 3410-34-P