[Federal Register Volume 60, Number 121 (Friday, June 23, 1995)]
[Notices]
[Pages 32650-32651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15379]
========================================================================
Notices
Federal Register
________________________________________________________________________
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.
========================================================================
Federal Register / Vol. 60, No. 121 / Friday, June 23, 1995 /
Notices
[[Page 32650]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 95-016-2]
Availability of Determination of Nonregulated Status for
Genetically Engineered Tomato Lines
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public of our determination that tomato
lines developed by Zeneca Plant Science and Petoseed Company, Inc.,
designated as B, Da, and F that have been genetically engineered for
suppressed polygalacturonase enzyme activity are no longer considered
regulated articles under our regulations governing the introduction of
certain genetically engineered organisms. Our determination is based on
our evaluation of data submitted by Zeneca Plant Science and Petoseed
Company, Inc., in their petition for a determination of nonregulated
status, an analysis of other scientific data, and our review of
comments received from the public in response to a previous notice
announcing our receipt of the Zeneca Plant Science and Petoseed, Inc.,
petition. This notice also announces the availability of our written
determination document and its associated environmental assessment and
finding of no significant impact.
EFFECTIVE DATE: June 6, 1995.
ADDRESSES: The determination, an environmental assessment and finding
of no significant impact, the petition, and all written comments
received regarding the petition may be inspected at USDA, room 1141,
South Building, 14th Street and Independence Avenue SW., Washington,
DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except
holidays. Persons wishing to inspect those documents are asked to call
in advance of visiting at (202) 690-2817.
FOR FURTHER INFORMATION CONTACT: Dr. Subhash Gupta, Biotechnologist,
Biotechnology Permits, BBEP, APHIS, 4700 River Road Unit 147,
Riverdale, MD 20737-1237; (301) 734-7612. To obtain a copy of the
determination or the environmental assessment and finding of no
significant impact, contact Ms. Kay Peterson at (301) 734-7612.
SUPPLEMENTARY INFORMATION:
Background
On February 7, 1995, the Animal and Plant Health Inspection Service
(APHIS) received a petition (APHIS Petition No. 94-290-01p) from Zeneca
Plant Science of Wilmington, DE, and Petoseed Company, Inc., of
Woodland, CA, (Zeneca/Petoseed) seeking a determination that tomato
lines designated as B, Da, and F that have been genetically engineered
for suppressed polygalacturonase (PG) enzyme activity do not present a
plant pest risk and, therefore, are not regulated articles under APHIS'
regulations in 7 CFR part 340.
On March 17, 1995, APHIS published a notice in the Federal Register
(60 FR 14413-14414, Docket No. 95-016-1) announcing receipt of the
Zeneca/Petoseed petition and announcing that the petition was available
for public review. The notice also discussed the role of APHIS and the
Food and Drug Administration in regulating the subject tomato lines and
food products derived from them. In the notice, APHIS solicited written
comments from the public as to whether the subject tomato lines posed a
plant pest risk. The comments were to have been received by APHIS on or
before May 16, 1995.
APHIS received five comments on the Zeneca/Petoseed petition, from
a food company, a seed company, and State departments of agriculture.
All the commenters supported the Zeneca/Petoseed petition for
nonregulated status for the subject tomato lines.
Analysis
Zeneca/Petoseed's tomato lines B, Da, and F have been developed
from an unmodified proprietary inbred tomato line coded as T7, that has
been genetically engineered to contain a fragment of the tomato PG gene
in the sense or antisense orientation. Inhibition of the PG enzyme
resulting from the transcription of the PG gene fragment results in an
increased thickness of the tomato, which is a desired characteristic in
processing tomatoes. The subject tomato lines also contain the
bacterial neomycin phosphotransferase (nptII) gene that is used as a
selectable marker. Tomato lines B, Da, and F were transformed through
the use of disarmed vectors from a common soil-borne bacterium, the
plant pathogen Agrobacterium tumafaciens. The subject tomato lines have
been considered regulated articles under APHIS' regulations in 7 CFR
part 340 because they contain certain gene sequences derived from
plant-pathogenic sources. However, evaluation of field data reports
from field tests of the subject tomato lines conducted under APHIS
permits or notifications since 1991 indicate that there were no
deleterious effects on plants, nontarget organisms, or the environment
as a result of the subject tomato plants' release into the environment.
Determination
Based on its analysis of the data submitted by Zeneca/Petoseed and
a review of other scientific data, comments received from the public,
and field tests of the subject tomato lines, APHIS has determined that
tomato lines B, Da, and F: (1) Exhibit no plant pathogenic properties;
(2) are no more likely to become a weed than tomatoes with suppressed
PG activity developed by traditional breeding techniques; (3) are
unlikely to increase the weediness potential of any other cultivated
plant or wild species with which they can interbreed; (4) are unlikely
to harm other organisms, such as bees, which are beneficial to
agriculture; and (5) should not cause damage to processed agricultural
commodities.
The effect of this determination is that tomato lines designated as
B, Da, and F are no longer considered regulated articles under APHIS'
regulations in 7 CFR part 340. Therefore, the permit and notification
requirements pertaining to regulated articles under those regulations
no longer apply to the field testing, importation, or interstate
movement of the subject tomato lines or their progeny. However, the
importation of the subject tomato lines or seeds capable of propagation
is still subject to [[Page 32651]] the restrictions found in APHIS'
foreign quarantine notices in 7 CFR part 319.
National Environmental Policy Act
An environmental assessment (EA) has been prepared to examine the
potential environmental impacts associated with this determination. The
EA was prepared in accordance with: (1) The National Environmental
Policy Act of 1969 (NEPA) (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 EA, APHIS has reached a
finding of no significant impact (FONSI) with regard to its
determination that the subject tomato lines and lines developed from
them are no longer regulated articles under its regulations in 7 CFR
part 340. Copies of the EA and the FONSI are available upon request
from the individual listed under FOR FURTHER INFORMATION CONTACT.
Done in Washington, DC, this 15th day of June 1995.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-15379 Filed 6-22-95; 8:45 am]
BILLING CODE 3410-34-P
