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

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.

-----------------------------------------------------------------------

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]

BILLING CODE 3410-34-P