00-15622. Monsanto Co.; Availability of Environmental Assessment for Extension of Determination of Nonregulated Status for Corn Genetically Engineered for Glyphosate Herbicide Tolerance

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public that an environmental assessment has been prepared for a proposed decision to extend to one additional corn line our determination that a corn line developed by Monsanto Company, 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. We are making this environmental assessment available to the public for review and comment.

DATES:

We will consider all comments that we receive by July 21, 2000.

ADDRESSES:

Please send your comment and three copies to: Docket No. 00-026-1, Regulatory Analysis and Development,

PPD, APHIS, Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 00-026-1.

You may read the extension request and the environmental assessment 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. To be sure someone is there to help you, please call [phone] before coming.

FOR FURTHER INFORMATION CONTACT:

Dr. John Turner, Biotechnology Assessments Section, Permits and Risk Assessments, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; [phone]. To obtain a copy of the extension request or the environmental assessment, contact Ms. Kay Peterson at [phone]; e-mail: [e-mail].

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 § 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. Further, the regulations in § 340.6(e)(2) provide that a person may request that APHIS extend a determination of nonregulated status to other organisms. Such a request must include information to establish the similarity of the antecedent organism and the regulated article in question.

Background

On January 11, 2000, APHIS received a request for an extension of a determination of nonregulated status (APHIS No. 00-11-01p) from Monsanto Company (Monsanto) of St. Louis, MO, for a corn line designated as Roundup Ready® corn line NK603 (NK603), which has been genetically engineered for tolerance to the herbicide glyphosate. The Monsanto request seeks an extension of a determination of nonregulated status issued for Roundup Ready® corn line GA21 (GA21) in response to APHIS petition number 97-099-01p (62 FR 64350-64351, December 5, 1997, Docket No. 97-052-2). Based on the similarity of NK603 to GA21, the antecedent organism, Monsanto requests a determination that glyphosate-tolerant corn line NK603 does not present a plant pest risk and, therefore, is not a regulated article under APHIS' regulations in 7 CFR part 340.

Analysis

Like the antecedent organism, corn line NK603 has been genetically engineered to contain an enzyme, 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS), that imparts tolerance to the herbicide glyphosate. However, corn was the source of the EPSPS enzyme in the antecedent organism, while the EPSPS enzyme in NK603 was derived from Agrobacterium sp. strain CP4. The subject corn line and the antecedent organism were developed through use of the particle acceleration method, and expression of the added genes in NK603 and the antecedent organism is controlled in part by gene sequences derived from the plant pathogen A. tumefaciens.

Corn line NK603 and the antecedent organism were genetically engineered using the same transformation method and contain a functionally equivalent enzyme that makes the plants tolerant to the herbicide glyphosate. Accordingly, we have determined that corn line NK603 is similar to the antecedent organism in APHIS petition number 97-099-01p, and we are proposing that this line should no longer be regulated under the regulations in 7 CFR part 340.

The subject corn line 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 NK603 conducted under APHIS notifications since 1997 indicates that there were no deleterious effects on plants, nontarget organisms, or the environment as a result of its environmental release.

Should APHIS approve Monsanto's request for an extension of a determination of nonregulated status, corn line NK603 would no longer be considered a regulated article under APHIS' regulations in 7 CFR part 340. Therefore, the requirements pertaining to regulated articles under those regulations would no longer apply to the field testing, importation, or interstate movement of the subject corn line or its progeny.

National Environmental Policy Act

An environmental assessment (EA) has been prepared to examine any potential environmental impacts associated with this proposed extension of a determination of nonregulated status. 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). Copies of Monsanto's extension request and the EA are available upon request from the individual listed under FOR FURTHER INFORMATION CONTACT.

Done in Washington, DC, this 15th day of June 2000.

Craig A. Reed,

Administrator, Animal and Plant Health Inspection Service.