[Federal Register Volume 61, Number 70 (Wednesday, April 10, 1996)]
[Notices]
[Pages 15919-15920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8904]



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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 95-097-2]


Agritope, Inc.; Availability of Determination of Nonregulated 
Status for Cherry Tomato Line Genetically Engineered for Modified Fruit 
Ripening

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that a cherry 
tomato line developed by Agritope, Inc., designated as 35-1-N that has 
been genetically engineered for modified fruit ripening is no longer 
considered a regulated article under our regulations governing the 
introduction of certain genetically engineered organisms. Our 
determination is based on our evaluation of data submitted by Agritope, 
Inc., in its petition for a determination of nonregulated status, an 
analysis of other scientific data, and our review of comments received 
from the public in response to a previous notice announcing our receipt 
of the Agritope, Inc., 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: March 27, 1996.

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

[[Page 15920]]
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, Biotechnology Permits, 
BBEP, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1237; (301) 
734-7612. To obtain a copy of the determination or the environmental 
assessment and finding of no significant impact, contact Ms. Kay 
Peterson at (301) 734-7612; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    On November 20, 1995, the Animal and Plant Health Inspection 
Service (APHIS) received a petition (APHIS Petition No. 95-324-01p) 
from Agritope, Inc., (Agritope) of Beaverton, OR, seeking a 
determination that a cherry tomato line designated as 35-1-N that has 
been genetically engineered for modified fruit ripening does not 
present a plant pest risk and, therefore, is not a regulated article 
under APHIS' regulations in 7 CFR part 340.
    On January 23, 1996, APHIS published a notice in the Federal 
Register (61 FR 1743-1744, Docket No. 95-097-1) announcing that the 
Agritope petition had been received and was available for public 
review. The notice also discussed the role of APHIS and the Food and 
Drug Administration in regulating the subject tomato line and food 
products derived from it. In the notice, APHIS solicited written 
comments from the public as to whether the subject tomato line posed a 
plant pest risk. The comments were to have been received by APHIS on or 
before March 25, 1996.
    During the designated 60-day comment period, APHIS received a total 
of 21 comments on the petition for cherry tomato line 35-1-N from 
individuals, a seed company, a State department of agriculture, and a 
university. All of the comments were in support of the subject 
petition.

Analysis

    Cherry tomato line 35-1-N has been genetically engineered to 
contain the sam-k gene derived from Escherichia coli bacteriophage T3 
that encodes an enzyme, S-adenosylmethionine hydrolase (SAMase), which 
alters the ethylene biosynthetic pathway and delays ripening of the 
tomato on the vine. When exposed to exogenous ethylene the fruit of 
line 35-1-N ripen normally. The subject cherry tomato line also 
contains the nptII gene from the prokaryotic transposon Tn5, which 
encodes the enzyme neomycin phosphotransferase II and is used as a 
selectable marker for transformation. Expression of the introduced 
genes is controlled in part by the 3' region of the nopaline synthase 
gene from the plant pathogen Agrobacterium tumefaciens. The A. 
tumefaciens vector system was used to transfer the added genes into the 
Large Red Cherry parental line.
    Cherry tomato line 35-1-N has been considered a regulated article 
under APHIS' regulations in 7 CFR part 340 because it contains 
regulatory gene sequences derived from the plant pathogen A. 
tumefaciens. However, evaluation of field data reports from field tests 
of the subject tomato line conducted under APHIS permits or 
notifications since 1992 indicates that there were no deleterious 
effects on plants, nontarget organisms, or the environment as a result 
of the subject tomato plants' release into the environment.

Determination

    Based on its analysis of the data submitted by Agritope and a 
review of other scientific data, comments received, and field tests of 
the subject tomato line, APHIS has determined that cherry tomato line 
35-1-N: (1) Exhibits no plant pathogenic properties; (2) is no more 
likely to become a weed than cherry tomato cultivars developed by 
traditional breeding techniques; (3) is unlikely to increase the 
weediness potential for any other cultivated or wild species with which 
it can interbreed; (4) will not harm threatened or endangered species 
or other organisms, such as bees, that are beneficial to agriculture; 
and (5) will not cause damage to raw or processed agricultural 
commodities. Therefore, APHIS has concluded that cherry tomato line 35-
1-N and any progeny derived from hybrid crosses with other 
nontransformed tomato varieties will be just as safe to grow as 
traditionally bred cherry tomato lines that are not regulated under 7 
CFR part 340.
    The effect of this determination is that Agritope's cherry tomato 
line designated as 35-1-N is no longer considered a regulated article 
under APHIS' regulations in 7 CFR part 340. Therefore, the 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 cherry tomato line 35-1-N or seeds capable of 
propagation is 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 of 1969 (NEPA)(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' NEPA Implementing 
Procedures (7 CFR part 372). Based on that EA, APHIS has reached a 
finding of no significant impact (FONSI) with regard to its 
determination that Agritope's cherry tomato line 35-1-N and lines 
developed from it 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 4th day of April 1996.
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-8904 Filed 4-9-96; 8:45 am]
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