[Federal Register Volume 60, Number 145 (Friday, July 28, 1995)]
[Notices]
[Pages 38788-38789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18572]



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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 95-056-1]


Addition of Two Genetically Engineered Tomato Lines 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 two genetically engineered tomato lines to those 
subject to its October 19, 1992, interpretive ruling that certain FLAVR 
SAVRTM lines need no longer be regulated. The effect of this 
action is that two 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. Subhash Gupta, Biotechnologist, 
Biotechnology Permits, BBEP, APHIS, 4700 River Road Unit 147, 
Riverdale, MD 20737-1237; (301) 734-8761.

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. 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 that action was that previously field 
tested lines of the FLAVR SAVRTM tomato and their progeny 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 were 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 a permit. Since the publication of the 
October 19, 1992, determination, a total of 30 FLAVR SAVRTM tomato 
lines have been added to the original determination; those additions 
were announced in notices published in the Federal Register on October 
3, 1994 (59 FR 50220, Docket No. 94-096-1); November 18, 1994 (59 FR 
59746, Docket No. 94-125-1); and March 23, 1995 (60 FR 15284, Docket 
No. 95-015-1).
    The FLAVR SAVRTM tomato lines that are the subject of this 
notice, designated 519a 4109a-4645 and 540a 4109a-1823, were 
constructed using the plasmid pCGN4109, which contains the promoter/
terminator from either pCGN1557 or pCGN1578. These latter 

[[Page 38789]]
two vectors were among the seven included in Calgene's initial petition 
to APHIS. FLAVR SAVRTM tomato lines constructed using these 
vectors were not included in our October 19, 1992, determination 
because they had not yet been field tested. These lines have since been 
field tested in accordance with APHIS' regulations in 7 CFR part 340, 
and data provided to APHIS indicate that the new transformants, 
produced in a manner identical to the earlier transformant lines, 
behave similarly to those earlier FLAVR SAVRTM tomato lines to 
which the original determination 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 October 19, 1992, of nonregulated 
status of previously tested FLAVR SAVRTM tomato lines applies as 
well to the new transformed lines.

    Done in Washington, DC, this 18th day of July 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-18572 Filed 7-27-95; 8:45 am]
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