Animal and Plant Health Inspection Service, USDA.
We are advising the public of our determination that the Monsanto and KWS SAAT AG sugar beet designated as event H7-1, 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 and KWS SAAT AG in its petition for a determination of nonregulated status, our 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 written determination and our finding of no significant impact.
March 4, 2005.
You may read a copy of the determination, the environmental assessment and finding of no significant impact, the petition for a determination of nonregulated status submitted by Monsanto Company and KWS SAAT AG, and all comments received on the petition and the environmental assessment 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.
You may view APHIS documents published in the Federal Register and related information on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Mr. John Cordts, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-5531. To obtain copies of the petition, the environmental assessment (EA), finding of no significant impact (FONSI), or the determination, contact Ms. Ingrid Berlanger at (301) 734-4885; e-mail: Ingrid.E.Berlanger@aphis.usda.gov. The petition, EA, FONSI, and determination are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/03_32301p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/03_32301p_ea.pdf.End Further Info End Preamble Start Supplemental 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. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.
On November 19, 2003, APHIS received a petition (APHIS Petition Number 03-323-01p) from Monsanto Company of St. Louis, MO, and KWS SAAT AG of Einbeck, Germany (Monsanto/KWS), requesting a determination of nonregulated status under 7 CFR part 340 for sugar beet (Beta vulgaris ssp. vulgaris) designated as event H7-1, which has been genetically engineered for tolerance to the herbicide glyphosate. The Monsanto/KWS petition states that the subject sugar beet should not be regulated by APHIS because it does not present a plant pest risk.
On October 19, 2004, APHIS published a notice in the Federal Register (69 FR 61466-61467, Docket No. 04-075-1) announcing that the Monsanto/KWS petition and an environmental assessment (EA) were available for public review. That notice also discussed the role of APHIS, the Environmental Protection Agency, and the Food and Drug Administration in regulating the subject sugar beet and food products developed from it. APHIS received 44 comments on the petition and the EA during the 60-day comment period, which ended December 20, 2004.
The comments were received from growers and grower associations, sugar processing cooperatives, academic researchers, seed companies, two biodynamic farmers, and one consumer organization. Forty-one of the comments supported approval of the petition in full. Three comments opposed the petition. One, a sugar processor, opposed the petition based on potential economic concerns; the biodynamic farmers generally opposed biotechnology, and the consumer group also opposed biotechnology and suggested that the EA is inadequate and an environmental impact statement should be prepared. APHIS disagrees with the suggestion of the consumer group and has provided a response to all of the comments as an attachment to the finding of no significant impact (FONSI). The EA and FONSI are available as indicated under FOR FURTHER INFORMATION CONTACT.
Sugar beet event H7-1 has been genetically engineered to express a 5-enolpyruvyshikimate-3-phosphate synthase protein from Agrobacterium sp. strain CP4 (CP4 EPSPS), which confers tolerance to the herbicide glyphosate. Expression of the added genes is controlled in part by the 35S promoter derived from the plant pathogen figwort mosaic virus. The Agrobacterium tumefaciens Start Printed Page 13008transformation method was used to transfer the added genes into the KWS proprietary sugar beet line 3S0057.
Sugar beet event H7-1 has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from plant pathogens. In the process of reviewing the notifications for field trials of the subject sugar beet, APHIS determined that the vectors and other elements were disarmed and that the trials, which were conducted under conditions of reproductive and physical confinement or isolation, would not present a risk of plant pest introduction or dissemination.
Based on its analysis of the data submitted by Monsanto/KWS, a review of other scientific data, field tests of the subject sugar beet, and comments submitted by the public, APHIS has determined that H7-1 sugar beet : (1) Exhibits no plant pathogenic properties; (2) is no more likely to become weedy than the nontransgenic parental line or other cultivated sugar beet; (3) is unlikely to increase the weediness potential of any other cultivated or wild species with which it can interbreed; (4) will not cause damage to raw or processed agricultural commodities; (5) will not harm threatened or endangered species or organisms that are beneficial to agriculture; and (6) should not reduce the ability to control pests and weeds in sugar beet or other crops. Therefore, APHIS has concluded that the subject sugar beet and any progeny derived from hybrid crosses with other non-transformed sugar beet varieties will be as safe to grow as sugar beets in traditional breeding programs that are not subject to regulation under 7 CFR part 340. The effect of this determination is that Monsanto/KWS' H7-1 sugar beet 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 sugar beet or its progeny. However, importation of H7-1 sugar beet and seeds capable of propagation are still subject to the restrictions found in APHIS' foreign quarantine notices in 7 CFR part 319 and imported seed regulations in 7 CFR part 361.
National Environmental Policy Act
An EA was prepared to examine any potential environmental impacts associated with the proposed determination of nonregulated status for the subject sugar beet event. 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 the determination that Monsanto/KWS H7-1 sugar beet and lines developed from it are no longer regulated articles under its regulations in 7 CFR part 340. Copies of the EA and FONSI are available from the individual listed under FOR FURTHER INFORMATION CONTACT.Start Signature
Done in Washington, DC, this 11th day of March 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-5302 Filed 3-16-05; 8:45 am]
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