Animal and Plant Health Inspection Service, USDA.
We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Vector Tobacco (USA) Ltd., seeking a determination of nonregulated status for tobacco designated as Vector 21-41, which has been genetically engineered for reduced nicotine. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. In accordance with those regulations, we are soliciting public comments on whether this tobacco presents a plant pest risk. We are also making available for public comment an environmental assessment for the proposed determination of nonregulated status.
We will consider all comments we receive that are postmarked, delivered, or e-mailed by April 15, 2002.
You may submit comments by postal mail/commercial delivery or by e-mail. If you use postal mail/commercial delivery, please send four copies of your comment (an original and three copies) to: Docket No. 01-060-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 01-060-1. If you use e-mail, address your comment to firstname.lastname@example.org. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and “Docket No. 01-060-1” on the subject line.
You may read a copy of the petition for a determination of nonregulated status submitted by Vector Tobacco (USA) Ltd., the environmental assessment, and any comments we receive on this notice of availability 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 Assessments Section, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-4886. To obtain a copy of the petition or the environmental assessment, contact Ms. Kay Peterson at (301) 734-4885; e-mail: Kay.Peterson@aphis.usda.gov.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 Section 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 Section 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 May 1, 2001, 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.
As described in the petition, 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.
Vector 21-41 tobacco has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from a plant pathogen. The subject 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 Start Printed Page 6481present a risk of plant pest introduction or dissemination.
In Section 403 of the Plant Protection Act (Title IV, Pub. L. 106-224, 114 Stat. 438, 7 U.S.C. 7701-7772), plant pest is defined as any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: A protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or viroid, an infectious agent or other pathogen, or any article similar to or allied with any of the foregoing. APHIS views this definition very broadly. The definition covers direct or indirect injury, disease, or damage not just to agricultural crops, but also to plants in general, for example, native species, as well as to organisms that may be beneficial to plants, for example, honeybees, rhizobia, etc.
In accordance with the regulations in 7 CFR 340.6(d), we are publishing this notice to inform the public that APHIS will accept written comments regarding the Petition for Determination of Nonregulated Status from any interested person for a period of 60 days from the date of this notice. We are also soliciting written comments from interested persons on the environmental assessment (EA) prepared to provide the public with documentation of APHIS' review and analysis of any potential environmental impacts and plant pest risk associated with a proposed determination of nonregulated status for Vector 21-41 tobacco. 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). The petition and the EA and any comments received on these documents are available for public review, and copies of the petition and the EA may be ordered (see the FOR FURTHER INFORMATION CONTACT section of this notice).
After the comment period closes, APHIS will review the data submitted by the petitioner, all written comments received during the comment period, and any other relevant information. After reviewing and evaluating the comments on the petition and the EA and other data and information, APHIS will furnish a response to the petitioner, either approving the petition in whole or in part, or denying the petition. APHIS will then publish a notice in the Federal Register announcing the regulatory status of Vector's reduced-nicotine Vector 21-41 tobacco and the availability of APHIS' written decision.Start Signature
Done in Washington, DC, this 6th day of February 2002.
W. Ron Dehaven,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-3342 Filed 2-11-02; 8:45 am]
BILLING CODE 3410-34-P