[Federal Register Volume 59, Number 222 (Friday, November 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28540]


[[Page Unknown]]

[Federal Register: November 18, 1994]


                                                   VOL. 59, NO. 222

                                          Friday, November 18, 1994

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 94-125-1]

 

Determination of Nonregulated Status for Additional Calgene, 
Inc., Genetically Engineered FLAVR SAVRTM Tomato Lines

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 nine additional genetically engineered tomato lines 
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 nine additional 
delayed softening tomato lines, which have been modified by the 
incorporation of genetic material described by Calgene, Inc., in its 
initial request for an interpretive ruling, will no longer be subject 
to regulation under 7 CFR part 340.

FOR FURTHER INFORMATION CONTACT: Dr. Keith Reding, Biotechnologist; 
Biotechnology, Biologics, and Environmental Protection; APHIS, USDA, 
Room 850, Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782, 
(301) 436-8761.

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 previously field tested lines of the 
Calgene, Inc., FLAVR SAVRTM tomato do not present a plant pest 
risk and are not regulated articles under the regulations contained in 
7 CFR part 340. This 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 progeny would no 
longer be regulated under these regulations.
    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 the Agency 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. One additional FLAVR SAVRTM 
tomato line was added to the original determination on October 3, 1994 
(59 FR 50220, Docket No. 94-096-1).
    The nine additional FLAVR SAVRTM tomato lines that are the 
subject of this notice were constructed using the plasmid PCGN4109, 
which contains the promoter/terminator from either PCGN1557 or 
PCGN1578. These latter two vectors were among the seven included in 
Calgene's initial petition to APHIS. In our determination on October 
19, 1992, the lines using these vectors were not deregulated because 
they had not been field tested. These lines have been field tested in 
accordance with APHIS regulations at 7 CFR part 340, and data provided 
to APHIS indicate that the new transformant lines, produced in a manner 
identical to the earlier transformant lines, behave similarly to those 
earlier FLAVR SAVRTM tomato lines to which the determination 
initially applied. Reports from field trials and other data indicate 
that the new tomato lines grow normally, exhibit the expected 
morphological, reproductive, and physiological properties, and do not 
have unexpected pest or disease susceptibility or symptoms. Therefore, 
the APHIS determination of nonregulated status for previously field 
tested FLAVR SAVRTM tomato lines of October 19, 1992, applies as 
well to the new transformed lines.

    Done in Washington, DC, this 14th day of November 1994.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 94-28540 Filed 11-17-94; 8:45 am]
BILLING CODE 3410-34-P