[Federal Register Volume 59, Number 190 (Monday, October 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24374]
[[Page Unknown]]
[Federal Register: October 3, 1994]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 94-096-1]
Addition of One Genetically Engineered Tomato Line to
Determination of Nonregulated Status for Calgene, Inc.
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: The Animal and Plant Health Inspection Service is announcing
that it has added one genetically engineered tomato line to those
subject to its October 19, 1992, interpretive ruling for FLAVR
SAVRTM tomatoes, that the subject FLAVR SAVRTM lines need no
longer be regulated. The effect of this action is that one additional
delayed-softening tomato line, which has been modified by the addition
of genetic material identical to that added to other tomato lines
covered by the initial determination and is designated by Calgene as
FLAVR SAVRTM line N73 1436-111, will also no longer be subject to
regulation under 7 CFR part 340.
FOR FURTHER INFORMATION CONTACT: Dr. Michael G. Schechtman, Senior
Microbiologist, Biotechnology Coordination and Technical Assistance,
BBEP, APHIS, USDA, room 850, Federal Building, 6505 Belcrest Road,
Hyattsville, MD 20782, (301) 436-7601.
SUPPLEMENTARY INFORMATION: On October 19, 1992, the Animal and Plant
Health Inspection Service (APHIS) published in the Federal Register (57
FR 47608-47616, Docket No. 92-087-2) a notice announcing the issuance
of an interpretive ruling that the Calgene, Inc., FLAVR SAVRTM
tomato does not present a plant pest risk and is not a regulated
article under the regulations contained in 7 CFR part 340. That action
was in response to a petition submitted by Calgene seeking a
determination from APHIS that its FLAVR SAVRTM tomato no longer be
deemed a regulated article based on an absence of plant pest risk. The
effect of the action was that previously field-tested lines of the
FLAVR SAVRTM tomato and their descendants would no longer be
regulated under the regulations in 7 CFR part 340.
FLAVR SAVRTM tomatoes were defined by Calgene in its initial
petition to include any tomatoes transformed with one of seven
identified plasmid vectors that all carry an antisense copy of the
tomato polygalacturonase gene and a bacterial neomycin
phosphotransferase gene with associated regulatory sequences. Calgene's
initial request to APHIS in 1992 was for a determination pertaining to
all FLAVR SAVRTM transformants produced in tomato using any one of
the seven plasmid vectors. Calgene indicated in its petition that data
provided to APHIS was representative of the data gathered for all lines
tested up to that time. The initial determination announced by APHIS on
October 19, 1992, only applied to those lines that had already been
field tested. However, APHIS indicated that new lines were likely to
exhibit properties similar to those of lines already field tested under
permit. The determination also allowed for cross-breeding of the
identified FLAVR SAVRTM tomato lines with any other lines or
cultivars of tomato without permit.
The new line that is the subject of this notice was a new
transformant produced using one of the same plasmid vectors that were
previously reviewed in our October 19, 1992, determination. Line N73
1436-111 has been field tested in accordance with APHIS regulations in
7 CFR part 340. Data provided to APHIS indicates that the new
transformant line, produced in a manner identical to the earlier
transformant lines, behaves similarly to those earlier FLAVR
SAVRTM tomato lines to which the determination initially applied.
Reports from field trials and other data indicate that tomato line N73
1436-111 grows normally, exhibits the expected morphological,
reproductive, and physiological properties, and does not have
unexpected pest or disease susceptibility or symptoms. Therefore,
APHIS' determination of nonregulated status of October 19, 1992, is
considered to apply to this new transformant line as well.
Done in Washington, DC, this 27th day of September 1994.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 94-24374 Filed 9-30-94; 8:45 am]
BILLING CODE 3410-34-P
