Environmental statements; availability, etc.: Nonregulated status determinations AgrEvo USA Co.; genetically engineered soybeans,
[Federal Register: October 22, 1998 (Volume 63, Number 204)]
[Notices]
[Page 56603-56604]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22oc98-37]
Notices Federal Register
This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section.
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 98-100-1]
AgrEvo USA Co.; Extension of Determination of Nonregulated Status for Soybean Genetically Engineered for Glufosinate 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 soybean line our determination that certain soybean lines developed by AgrEvo USA Company, which have been genetically engineered for glufosinate herbicide tolerance, are no longer considered regulated articles under our regulations governing the introduction of certain genetically engineered organisms. Our decision is based on our evaluation of data submitted by AgrEvo USA Company in its request for an extension of a determination of nonregulated status and an analysis of other scientific data. This notice also announces the availability of an environmental assessment and finding of no significant impact.
EFFECTIVE DATE: November 23, 1998.
ADDRESSES: The extension request and an environmental assessment and finding of no significant impact 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.
FOR FURTHER INFORMATION CONTACT: Dr. Sivramiah Shantharam, Biotechnology and Biological Analysis, PPQ, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-4882. 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 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. Further, the regulations in Sec. 340.6(e)(2) provide that a person may request that APHIS extend a determination of nonregulated status to other organisms. Such a request shall include information to establish the similarity of the antecedent organism and the regulated article in question.
Background
On August 26, 1998, APHIS received a request for an extension of a determination of nonregulated status (APHIS No. 98-238-01p) from AgrEvo USA Company (AgrEvo) of Wilmington, DE, for a soybean line designated as transformation event GU262 (event GU262), which has been genetically engineered for resistance, or tolerance, to the herbicide glufosinate. The AgrEvo request seeks an extension of a determination of nonregulated status issued for certain lines of glufosinate tolerant soybean (antecedent organisms) in response to APHIS petition number 96- 068-01p (61 FR 42581-42582, August 16, 1996, Docket No. 96-019-2). Based on the similarity of event GU262 soybean to the antecedent organisms, AgrEvo requests a determination that glufosinate tolerant soybean event GU262 does not present a plant pest risk and, therefore, is not a regulated article under APHIS' regulations in 7 CFR part 340.
Analysis
Event GU262 soybean contains a synthetic version of the pat gene derived from Streptomyces viridochromogenes. The pat gene encodes a phosphinothricin acetyltransferase (PAT) enzyme which confers tolerance to glufosinate. Expression of the synthetic pat gene is controlled by a 35S promoter and terminator derived from the plant pathogen cauliflower mosaic virus. While the subject soybean line contains fragments of the bla marker gene, tests indicate this gene is not expressed in the plant. The particle acceleration method was used to transfer the added genes into the parental Glycine max PH12 cultivar. Event GU262 soybean was transformed with the same plasmid vector and in the same manner as certain antecedent organisms described in APHIS petition number 96-068- 01p, and differs from them only in the copy number and extent of integrated DNA. Accordingly, we have determined that the event GU262 soybean line is similar to the antecedent organisms in petition 96-068- 01p and therefore does not need to be regulated.
The subject soybean 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 this soybean line conducted under APHIS notifications since 1996 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 AgrEvo and a review of other scientific data and field tests of the subject soybean line, APHIS has determined that event GU262 soybean: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become a weed than soybean lines 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
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threatened or endangered species or other organisms, such as bees, that are beneficial to agriculture. Therefore, APHIS has concluded that the subject soybean line and any progeny derived from crosses with other soybean varieties will be as safe to grow as soybeans that are not subject to regulation under 7 CFR part 340.
Since APHIS has determined that event GU262 soybean does not pose a plant pest risk and is similar to the antecedent organisms, AgrEvo's event GU262 soybean 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 field testing, importation, or interstate movement of the subject soybean line or its progeny. However, importation of the subject soybean line 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, as amended (NEPA)(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 GU262 soybean 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 16th day of October 1998. Joan M. Arnoldi, Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-28283Filed10-21-98; 8:45 am]
BILLING CODE 3410-34-P
