Monsanto Co.; Availability of Determination of Nonregulated Status for Canola Genetically Engineered for Glyphosate Herbicide Tolerance

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 98-089-2]

Monsanto Co.; Availability of Determination of Nonregulated

Status for Canola Genetically Engineered for Glyphosate Herbicide

Tolerance

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

Monsanto Company's canola line designated as RT73, which has been

genetically engineered for tolerance to the herbicide glyphosate, 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 Monsanto

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 27, 1999.

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. Subhash Gupta, Biotechnology and

Biological Analysis, PPQ, APHIS, 4700 River Road Unit 133, Riverdale,

MD 20737-1236; (301) 734-8761. 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:

Kay.P[email protected].

SUPPLEMENTARY INFORMATION:

Background

On August 4, 1998, the Animal and Plant Health Inspection Service

(APHIS) received a petition (APHIS Petition No. 98-216-01p) from

Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination

that a canola (Brassica napus L.) line designated as Roundup

Ready canola line RT73 (canola line RT73), which has been

genetically engineered for tolerance to the herbicide glyphosate, does

not present a plant pest risk and, therefore, is not a regulated

article under APHIS' regulations in 7 CFR part 340.

On October 16, 1998, APHIS published a notice in the Federal

Register (63 FR 55573-55574, Docket No. 98-089-1) announcing that the

Monsanto 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 line posed a plant pest risk. The comments were to have been

received by APHIS on or before December 15, 1998. APHIS received no

comments on the subject petition during the designated 60-day comment

period.

Analysis

Canola line RT73 has been genetically engineered to contain a CP4

EPSPS gene derived from Agrobacterium sp. strain CP4, and a modified

goxv247 gene derived from Ochrobactrum anthropi strain LBAA. The CP4

EPSPS gene encodes a 5-enolpyruvyl-shikimate-3-phosphate synthase (CP4

EPSPS) protein, and the goxv247 gene encodes a glyphosate

oxidoreductase (GOXv247) protein. The CP4 EPSPS and GOXv247 proteins

confer tolerance to the herbicide glyphosate. Expression of the added

genes is controlled in part by gene sequences derived from the plant

pathogen figwort mosaic virus, and the Agrobacterium tumefaciens method

was used to transfer the added genes into the parental canola Westar

variety plants.

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 and

notifications since 1995 indicates that there were no deleterious

effects on plants, nontarget organisms, or the environment as a result

of the environmental release of canola line RT73.

Determination

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

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

APHIS has determined that canola line RT73: (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 Monsanto's canola line

RT73 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 or its progeny. However, importation of canola line RT73

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.

[[Page 5629]]

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 Monsanto's canola line RT73 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 29th day of January 1999.

Thomas E. Walton,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 99-2656 Filed 2-3-99; 8:45 am]

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