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

SUMMARY: We are advising the public that the Animal and Plant Health

Inspection Service has received a petition from Agritope, Inc., seeking

a determination of nonregulated status for a cherry tomato line

designated as 35-1-N that has been genetically engineered for modified

fruit ripening. The petition has been submitted in accordance with our

regulations concerning the introduction of certain genetically

engineered organisms and products. In accordance with those

regulations, we are soliciting public comments on whether this cherry

tomato line presents a plant pest risk.

DATES: Written comments must be received on or before March 25, 1996.

ADDRESSES: Please send an original and three copies of your comments to

Docket No. 95-097-1, Regulatory Analysis and Development, PPD, APHIS,

Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please

state that your comments refer to Docket No. 95-097-1. A copy of the

petition and any comments received may be inspected at USDA, room 1141,

South Building, 14th Street and Independence Avenue SW., Washington,

DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except

holidays. Persons wishing access to that room to inspect the petition

or comments are asked to call in advance of visiting at (202) 690-2817.

FOR FURTHER INFORMATION CONTACT: Dr. Ved Malik, Biotechnology Permits,

BBEP, APHIS, Suite 5B05, 4700 River Road Unit 147, Riverdale, MD 20737-

1237; (301) 734-7612. To obtain a copy of the petition, contact Ms. Kay

Peterson at (301) 734-7612.

SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340,

``Introduction of Organisms and Products Altered or Produced Through

Genetic Engineering Which Are Plant Pests or Which There Is Reason to

Believe Are Plant Pests,'' regulate, among other things, the

introduction (importation, interstate movement, or release into the

environment) of organisms and products altered or produced through

genetic engineering that are plant pests or that there is reason to

believe are plant pests. Such genetically engineered organisms and

products are considered ``regulated articles.''

The regulations in Sec. 340.6(a) provide that any person may submit

a petition to the Animal and Plant Health Inspection Service (APHIS)

seeking a determination that an article should not be regulated under 7

CFR part 340. Paragraphs (b) and (c) of Sec. 340.6 describe the form

that a petition for determination of nonregulated status must take and

the information that must be included in the petition.

On November 20, 1995, APHIS received a petition (APHIS Petition No.

95-324-01p) from Agritope, Inc., (Agritope) of Beaverton, OR,

requesting a determination of nonregulated status under 7 CFR part 340

for a cherry tomato line designated as 35-1-N (line 35-1-N) that has

been genetically engineered to contain a gene that alters fruit

ripening. The Agritope petition states that cherry tomato line 35-1-N

should not be regulated by APHIS because it does not present a plant

pest risk.

As described in the petition, 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. The fruit of line 35-1-N ripen

normally when exposed to exogenous ethylene. The subject 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 added genes is

controlled by the untranslated 3' region of the nopaline synthase gene

from Agrobacterium tumefaciens. The modified E8 gene promoter from

tomatoes is used to drive the sam-k gene in a developmentally regulated

manner. The A. tumefaciens vector system was used to transfer the

construct pAG-5420 containing the DNA elements described above into the

Large Red Cherry parental line.

Line 35-1-N has been considered a regulated article under the

regulations in 7 CFR part 340 because it contains gene sequences from

the plant pathogen A. tumefaciens. The subject cherry tomato line has

been evaluated in field trials conducted since 1992 under APHIS permits

or notifications. In the process of reviewing the applications for

field trials of line 35-1-N, APHIS determined that the vectors and

other elements were disarmed and that the trials, which were conducted

under conditions of reproductive and physical containment or isolation,

would not present a risk of plant pest introduction or dissemination.

In the Federal Plant Pest Act, as amended (7 U.S.C. 150aa et seq.),

``plant pest'' is defined as ``any living stage of: Any insects, mites,

nematodes, slugs, snails, protozoa, or other invertebrate animals,

bacteria, fungi, other parasitic plants or reproductive parts thereof,

viruses, or any organisms similar to or allied with any of the

foregoing, or any infectious substances, which can directly or

indirectly injure or cause disease or damage in any plants or parts

thereof, or any processed, manufactured or other products of plants.''

APHIS views this definition very broadly. The definition covers direct

or indirect injury, disease, or damage not just to agricultural crops,

but also to plants in general, for example, native species, as well as

to organisms that may be beneficial to plants, for example, honeybees,

rhizobia, etc.

The Food and Drug Administration (FDA) published a statement of

policy on foods derived from new plant varieties in the Federal

Register on May 29, 1992 (57 FR 22984-23005). The FDA statement of

policy includes a discussion of FDA's authority for ensuring food

safety under the Federal

[[Page 1744]]

Food, Drug, and Cosmetic Act (21 U.S.C. 201 et seq.), and provides

guidance to industry on the scientific considerations associated with

the development of foods derived from new plant varieties, including

those plants developed through the techniques of genetic engineering.

In accordance with Sec. 340.6(d) of the regulations, we are

publishing this notice to inform the public that APHIS will accept

written comments regarding the Petition for Determination of

Nonregulated Status from any interested person for a period of 60 days

from the date of this notice. The petition and any comments received

are available for public review, and copies of the petition may be

ordered (see the ADDRESSES section of this notice).

After the comment period closes, APHIS will review the data

submitted by the petitioner, all written comments received during the

comment period, and any other relevant information. Based on the

available information, APHIS will furnish a response to the petitioner,

either approving the petition in whole or in part, or denying the

petition. APHIS will then publish a notice in the Federal Register

announcing the regulatory status of Agritope's cherry tomato line 35-1-

N and the availability of APHIS' written decision.

Authority: 7 U.S.C. 150aa-150jj, 151-167, and 1622n; 31 U.S.C.

9701; 7 CFR 2.22, 2.80, and 371.2(c).

Done in Washington, DC, this 17th day of January 1996.

Terry L. Medley,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 96-871 Filed 1-22-96; 8:45 am]

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