Monsanto Co.; 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 of our 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. Our decision is based on our evaluation of data submitted by Monsanto Company in its request for an extension of a determination of nonregulated status, an analysis of other scientific data, and comments received from the public in response to a previous notice. This notice also announces the availability of our finding of no significant impact.

EFFECTIVE DATE:

September 29, 2000.

ADDRESSES:

You may read the extension request, the environmental assessment and finding of no significant impact, and all comments received in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 690-2817 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; (301) 734-8365. To obtain a copy of the extension request or the environmental assessment and finding of no significant impact, contact Ms. Kay Peterson at (301) 734-4885; e-mail: kay.peterson@usda.gov.

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. 00-011-01p) 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. Monsanto requested an extension of a determination of nonregulated status issued previously for Roundup Ready corn line GA21 (GA21), 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 requested 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.

On June 21, 2000, APHIS published a notice in the Federal Register (65 FR 38494-38495, Docket No. 00-026-1) announcing that an environmental assessment (EA) for Monsanto's extension request had been prepared and was available for public comment. During the designated 30-day public comment period, APHIS received a total of two comments, both of which were from university colleges of agriculture, and both of which were in support of the subject extension request. The two commenters supporting nonregulated status for corn line NK603 stressed, among other things, its agronomic suitability, the low probability of introgression of the herbicide tolerance trait due to the absence of sexually compatible wild relatives, and the environmental benefits of glyphosate use in no-till and minimum tillage systems. The EA and the finding of no significant impact (FONSI) are available from the person listed under FOR FURTHER INFORMATION CONTACT.

Analysis

Like the antecedent organism, corn line NK603 has been genetically engineered to express an enzyme, 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS), that imparts tolerance to the herbicide glyphosate. Corn was the source of the EPSPS enzyme in the antecedent organism, while a functionally equivalent 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 Agrobacterium tumefaciens.

Corn line NK603 and the antecedent organism were genetically engineered using the same transformation method and contain a functionally equivalent enzyme which makes the plants tolerant to the herbicide glyphosate. Accordingly, we have determined that NK603 is similar to the antecedent organism GA21 in APHIS petition 97-099-01p and, therefore, 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 a plant pathogen. 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.

Determination

Based on an analysis of the data submitted by Monsanto, a review of other scientific data, and field tests of the subject corn line, APHIS has determined that corn line NK603: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become a weed than herbicide-tolerant corn varieties 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 corn line NK603 and any progeny derived from crosses with other corn varieties will be as safe to grow as corn that is not subject to regulation under 7 CFR part 340.

Because APHIS has determined that the subject corn line does not present a plant pest risk based on its similarity to the antecedent organism, Monsanto's corn line NK603 will 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 no longer apply to the field testing, importation, or interstate movement of the subject corn line or its progeny. However, importation of corn line NK603 and 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 EA was 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 FONSI with regard to its determination that Monsanto's corn line NK603 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.