Animal and Plant Health Inspection Service, USDA.
We are advising the public of our determination that the Vector Tobacco (USA) Ltd. tobacco designated as Vector 21-41, which has been genetically engineered for reduced nicotine, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms and products. Our determination is based on our evaluation of data submitted by Vector Tobacco (USA) Ltd. 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 document and our finding of no significant impact.
September 16, 2002.
You may read a copy of the determination, an environmental assessment and finding of no significant impact, the petition for a determination of nonregulated status submitted by Vector Tobacco (USA) Ltd., 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.
APHIS documents published in the Federal Register, and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Dr. Susan Koehler, Biotechnology Regulatory Services, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-4886. 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.Peterson@aphis.usda.gov.End Further Info End Preamble Start Supplemental Information
On May 1, 2001, the Animal and Plant Health Inspection (APHIS) received a petition (APHIS Petition No. 01-121-01p) from Vector Tobacco (USA) Ltd. (Vector) of Durham, NC, requesting a determination of nonregulated status under 7 CFR part 340 for tobacco (Nicotiana tabacum L.) designated as Vector 21-41, which has been genetically engineered to produce a very low level of nicotine. The Vector petition states that the subject tobacco should not be regulated by APHIS because it does not present a plant pest risk.
On February 12, 2002, APHIS published a notice in the Federal Register (67 FR 6480-6481, Docket No. 01-060-1) announcing that the Vector petition was available for public review. In the notice, APHIS solicited comments from the public on whether this tobacco presents a plant pest risk. APHIS also made available for public comment an environmental assessment for the proposed determination of nonregulated status. APHIS received 45 comments on the petition and the environmental assessment during the 60-day comment period which ended April 15, 2002. The comments were received from tobacco farmers, tobacco companies, State Start Printed Page 71930farmers' organizations, State department of agriculture officials, private individuals, tobacco growers' cooperatives, tobacco marketing organizations, university cooperative extension centers, members of the U.S. Congress, a foundation seed producer, an agronomic consultant, a county chamber of commerce, and a consumer organization. Twenty-three of the comments were in favor of a determination of nonregulated status for Vector 21-41 tobacco, and 22 comments either opposed deregulation or recommended no action on the petition until certain concerns are addressed about the effects of Vector 21-41 deregulation on traditional tobacco growers and markets. A majority of commenters in favor of deregulation stressed that Vector 21-41 did not present a plant pest risk, displayed disease and insect susceptibilities and agronomic characteristics similar to conventionally bred tobacco, and noted the benefits to local economies from growing Vector 21-41. Those commenters not expressing support for deregulation of the subject tobacco at this time generally expressed the following concerns about Vector 21-41: Blue mold and insect susceptibilities, the limited number of years of field testing, the potential for gene transfer to conventional tobacco, and the potential for commingling with conventional tobacco in the absence of growing and processing guidelines. One commenter found the environmental assessment inadequate, alleging that it failed to address the impacts of Vector 21-41 on organic farmers and certain human health effects, including the impacts of an antibiotic resistance gene. We have provided a response to the comments as an attachment to our finding of no significant impact, which is available from the person listed under FOR FURTHER INFORMATION CONTACT.
Vector 21-41 tobacco has been genetically engineered to express a quinolinic acid phosphoribosyltransferase (QPTase) in the reverse, or antisense position, which disrupts the normal expression of QPTase, a key enzyme in the biosynthetic pathway leading to the production of nicotine and related alkaloids. The effect of this genetic change is to reduce the nicotine levels of nicotine, nor-nicotine, and total alkaloids in the leaves of Vector 21-41 tobacco. The subject tobacco also contains the nptII marker gene derived from the bacterium Escherichia coli. The nptII gene encodes the enzyme neomycin phosphotransferase type II (NPTII) and is used as a selectable marker in the initial laboratory stages of plant cell selection. Expression of the added genes is controlled in part by gene sequences from the plant pathogen Agrobacterium tumefaciens. The A. tumefaciens method was used to transfer the added genes into the parental recipient Burley 21-LA tobacco variety.
The subject tobacco has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from a plant pathogen. Vector 21-41 tobacco has been field tested since 1999 in the United States under APHIS notifications. In the process of reviewing the notifications for field trials of this tobacco, APHIS determined that the vectors and other elements were disarmed and that the trials, which were conducted under conditions of reproductive and physical containment or isolation, would not present a risk of plant pest introduction or dissemination.
Based on its analysis of the data submitted by Vector, a review of other scientific data, field tests of the subject tobacco, and comments submitted by the public, APHIS has determined that Vector 21-41 tobacco: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become a weed than tobacco 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 organisms, such as bees, that are beneficial to agriculture. Therefore, APHIS has concluded that the subject tobacco and any progeny derived from hybrid crosses with other nontransformed tobacco varieties will be as safe to grow as tobacco in traditional breeding programs that is not subject to regulation under 7 CFR part 340.
The effect of this determination is that Vector's 21-41 tobacco 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 tobacco or its progeny. However, importation of Vector 21-41 tobacco 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 has been prepared to examine the potential environmental impacts associated with this determination. The environmental assessment 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 environmental assessment, APHIS has reached a finding of no significant impact with regard to its determination that Vector 21-41 tobacco and lines developed from it are no longer regulated articles under its regulations in 7 CFR part 340. Copies of the petition and the environmental assessment and finding of no significant impact are available upon request from the individual listed under the FOR FURTHER INFORMATION CONTACT section of this notice.Start Signature
Done in Washington, DC, this 26th day of November 2002 .
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-30518 Filed 12-2-02; 8:45 am]
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