[Federal Register: December 3, 2002 (Volume 67, Number 232)]
[Notices]
[Page 71929-71930]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de02-46]
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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:
Kay.Peterson@aphis.usda.gov.
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]
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