[Federal Register Volume 67, Number 29 (Tuesday, February 12, 2002)]
[Notices]
[Pages 6480-6481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3342]


 ========================================================================
 Notices
                                                 Federal Register
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 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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  Federal Register / Vol. 67, No. 29 / Tuesday, February 12, 2002 / 
Notices  

[[Page 6480]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 01-060-1]


Vector Tobacco; Availability of Petition and Environmental 
Assessment for Determination of Nonregulated Status for Tobacco 
Genetically Engineered for Reduced Nicotine

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: 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.

DATES: We will consider all comments we receive that are postmarked, 
delivered, or e-mailed by April 15, 2002.

ADDRESSES: 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 [email protected]. 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.

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: [email protected].

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 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

[[Page 6481]]

present 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.

    Authority: 7 U.S.C. 166, 1622n, 7756, and 7761-7772; 31 U.S.C. 
9701; 7 CFR 2.22, 2.80, and 371.3.

    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