[Federal Register Volume 61, Number 197 (Wednesday, October 9, 1996)]
[Notices]
[Page 52906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25933]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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  Federal Register / Vol. 61, No. 197 / Wednesday, October 9, 1996 / 
Notices  

[[Page 52906]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 96-080-1]


Calgene, Inc.; Addition of One Genetically Engineered Tomato Line 
to Determination of Nonregulated Status

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 additional genetically engineered tomato line to 
those subject to its October 19, 1992, interpretive ruling 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 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) 734-7612.

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 that 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 tomatoes using any one 
of the seven plasmid vectors. Calgene indicated in its petition that 
data provided to the Agency 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 32 
additional 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); March 23, 1995 (60 FR 15284, Docket No. 95-015-1); and July 28, 
1995 (60 FR 38788-38789, Docket No. 95-056-1).
    The additional FLAVR SAVRTM tomato line that is the subject of 
this notice was constructed using the plasmid vector pCGN4109, which 
was one of the seven included in Calgene's initial petition to APHIS. 
In our determination of October 19, 1992, the lines using these vectors 
were not deregulated because they had not been field tested. These 
lines have since been field tested in accordance with APHIS regulations 
at 7 CFR part 340, and data provided to APHIS indicate that the new 
transformant, 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 the new tomato 
line grows normally, exhibits the expected morphological, reproductive, 
and physiological properties, and does not have unexpected pest or 
disease susceptibility or symptoms. Therefore, the APHIS determination 
of nonregulated status of October 19, 1992, applies as well to this new 
transformed line.

    Done in Washington, DC, this 4th day of October 1996.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-25933 Filed 10-8-96; 8:45 am]
BILLING CODE 3410-34-P