[Federal Register Volume 60, Number 15 (Tuesday, January 24, 1995)]
[Notices]
[Pages 4588-4589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1622]
========================================================================
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. 15 / Tuesday, January 24, 1995 /
Notices
[[Page 4588]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 94-092-2]
Availability of Determination of Nonregulated Status for
Genetically Engineered Tomato Line
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public of our determination that a DNA
Plant Technology Corporation delayed-ripening tomato line, designated
as line 1345-4, is no longer considered a regulated article under our
regulations governing the introduction of certain genetically
engineered organisms. The determination is based on our analysis of a
petition submitted by DNA Plant Technology Corporation for a
determination of nonregulated status, and our review of scientific data
and comments received from the public in response to a previous notice
announcing receipt of the DNA Plant Technology Corporation's 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: January 17, 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. Ved Malik, Biotechnologist, Biotechnology Permits, BBEP, APHIS,
USDA, room 850, Federal Building, 6505 Belcrest Road, Hyattsville, MD
20782, (301) 436-7612. The telephone number for the agency will change
when agency offices in Hyattsville, MD, move to Riverdale, MD, during
February. Telephone: (301) 436-7612 (Hyattsville); (301) 734-7612
(Riverdale). To obtain a copy of the determination or the environmental
assessment and finding of no significant impact, contact Ms. Kay
Peterson at (301) 436-7601 (Hyattsville); (301) 734-7601 (Riverdale).
SUPPLEMENTARY INFORMATION:
Background
On August 16, 1994, the Animal and Plant Health Inspection Service
(APHIS) received a petition from DNA Plant Technology Corporation
(DNAP) of Oakland, CA, seeking a determination that its delayed-
ripening tomato line 1345-4 (tomato line 1345-4) and any progeny
derived from hybrid crosses between that line and other non-transformed
tomato varieties do not present a plant pest risk and, therefore, are
not regulated articles under APHIS' regulations in 7 CFR part 340.
On September 26, 1994, APHIS published a notice in the Federal
Register (59 FR 49055-49056, Docket No. 94-092-1) announcing receipt of
the DNAP petition and stating that the petition was available for
public review. The notice also discussed the role of APHIS and the Food
and Drug Administration in regulating tomato line 1345-4 and food
products derived from it. In the notice, APHIS solicited written
comments from the public as to whether tomato line 1345-4 posed a plant
pest risk. The comments were to have been received by APHIS on or
before November 25, 1994.
APHIS received seven comments on the DNAP petition submitted by
universities, State officials, and a tomato grower. One comment
concerned the information provided in the notice of receipt of the
petition; the remainder of the comments were in favor of the petition.
APHIS has provided a summary of the comments in the determination
document, which is available upon request from the individual listed
under FOR FURTHER INFORMATION CONTACT.
Analysis
Tomato line 1345-4, as described by its developer, DNAP, contains a
gene that delays ripening. Using TranswitchTM gene suppression
technology, DNAP introduced a truncated version of the tomato
aminocyclopropane carboxylate (ACC) synthase gene into the tomato
genome in the ``sense'' or normal orientation, resulting in tomato
plants that exhibit significantly reduced levels of ACC synthase. ACC
synthase is the rate-limiting enzyme that coverts s-adenosylmethionine
to 1-aminocyclopropane-1-carboxylic acid, the immediate precursor to
ethylene. Tomato line 1345-4 contains a gene which is derived from the
tomato ACC synthase gene, but which does not encode a functional ACC
synthase enzyme. Though the fruit of these plants exhibits delayed-
ripening, they ripen as usual when exogenous ethylene is applied.
Tomato line 1345-4 has also been transformed with the nptII gene from
E. coli that encodes the enzyme neomycin phosphotransferase II and
serves as a selectable marker enabling identification of the
transformed plant cells. This gene is fused to a nos promoter sequence
and octopine synthase termination sequence from A. tumefaciens, a known
plant pest.
Tomato line 1345-4 has been considered a regulated article under
APHIS' regulations in 7 CFR part 340 because the line has been
engineered using noncoding regulatory sequences derived from the plant
pathogens A. tumefaciens and cauliflower mosaic virus. However, field
tests of tomato line 1345-4 have been conducted at tomato growing
regions in the United States since 1992 under permits issued by APHIS,
and the field reports from those tests indicate that there were no
deleterious effects on plants, nontarget organisms, or the environment
as a result of this testing.
Determination
Based on its analysis of data submitted by DNAP, a review of other
scientific data and comments received from the public, APHIS has
determined that tomato line 1345-4: (1) Exhibits no plant pathogenic
properties; (2) is no more likely to become a weed than the
nonengineered parental variety; (3) is unlikely to increase the
weediness potential of any other cultivated plant or
[[Page 4589]] native wild species with which the organism can
interbreed; (4) is unlikely to harm other organisms, such as bees, that
are beneficial to agriculture; and (5) will not cause damage to
processed agricultural commodities. APHIS has also concluded that there
is a reasonable certainty that new progeny varieties bred from tomato
line 1345-4 will not exhibit new plant pest properties, i.e.,
properties substantially different from any observed in the field-
tested tomato line, or those observed in traditional tomato breeding
programs.
The effect of this determination is that tomato line 1345-4 and all
other lines bred from this line by sexual or asexual reproduction
involving Mendelian inheritance, 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 line or its
progeny. However, the importation of the tomato line and any nursery
stock 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 (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 (NEPA) of 1969 (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 Guidelines
Implementing NEPA (44 FR 50381-50384, August 28, 1979, and 44 FR 51272-
51274, August 31, 1979). Based on that EA, APHIS has reached a finding
of no significant impact (FONSI) with regard to its determination that
the tomato line designated as 1345-4 and other lines bred from the line
by sexual or asexual reproduction involving Mendelian inheritance, 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 17th day of January 1995.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-1622 Filed 1-23-95; 8:45 am]
BILLING CODE 3410-34-M
