[Federal Register Volume 67, Number 232 (Tuesday, December 3, 2002)]
[Notices]
[Pages 71929-71930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30518]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 01-060-2]


Vector Tobacco; Availability of 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 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.

EFFECTIVE DATE: September 16, 2002.

ADDRESSES: 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.

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: 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    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

[[Page 71930]]

farmers' 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.

Analysis

    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.

Determination

    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.

    Done in Washington, DC, this 26th day of November 2002 .
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-30518 Filed 12-2-02; 8:45 am]
BILLING CODE 3410-34-P