Receipt of Petition for Determination of Nonregulated Status for Genetically Engineered Tomato Line

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 94-092-1]

Receipt of Petition for Determination of Nonregulated Status for

Genetically Engineered Tomato Line

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

Inspection Service has received a petition from DNA Plant Technology

Corporation seeking a determination of nonregulated status for its

delayed-ripening tomato line 1345-4. 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 that

genetically engineered tomato line presents a plant pest risk.

DATES: Written comments must be received on or before November 25,

1994.

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

Chief, Regulatory Analysis and Development, PPD, APHIS, USDA, room 804,

Federal Building, 6505 Belcrest Road, Hyattsville, MD 20782. Please

state that your comments refer to Docket No. 94-092-1. 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.

To obtain a copy of the petition, contact Ms. Kay Peterson at (301)

436-7601.

FOR FURTHER INFORMATION CONTACT: Dr. Ved Malik, Biotechnologist,

Biotechnology Permits, BBEP, APHIS, USDA, room 850, Federal Building,

6505 Belcrest Road, Hyattsville, MD 20782, (301) 436-7612.

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 August 16, 1994, APHIS received a petition from DNA Plant

Technology Corporation (DNAP) of Oakland, CA, requesting a

determination of nonregulated status under 7 CFR part 340 for its

delayed-ripening tomato line 1345-4 and any progeny derived from hybrid

crosses between that line and other non-transformed tomato varieties.

The DNAP petition states that delayed-ripening tomato line 1345-4

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

pest risk.

As described in the petition, the delayed-ripening tomato line

1345-4 was developed using TranswitchTM gene suppression

technology to introduce a truncated version of an aminocyclopropane

carboxylate (ACC) synthase gene isolated from tomato into the tomato

genome in the ``sense'' (i.e. normal) orientation, which resulted in

tomato plants that exhibit significantly reduced levels of ACC synthase

and ethylene biosynthesis. Ethylene is an endogenous plant hormone

known to play an important role in fruit ripening in climacteric fruit

such as tomato. ACC synthase is the rate-limiting enzyme that converts

s-adenosylmethionine to 1-aminocyclopropane-1-carbolic acid, the

immediate precursor to ethylene. Inhibition of ACC synthase

biosynthesis results in reduced levels of ethylene biosynthesis. The

fruit of these plants exhibited a delayed-ripening phenotype, but

ripened normally when external ethylene was applied. The tomato line

for which DNAP is seeking a determination, line 1345-4, contains a gene

that is derived from the tomato ACC synthase gene but does not encode a

functional ACC synthase enzyme. Tomato plants were produced by

inserting the truncated ACC synthase gene into the genome of tomato

cultivar 91103-114.

DNAP's delayed-ripening tomato line 1345-4 is currently considered

a regulated article under the regulations in 7 CFR part 340 because it

contains gene sequences (vectors, promoters, and terminators) derived

from plant pathogenic sources. In the process of reviewing permit

applications for field trials of DNAP's delayed-ripening tomato line

1345-4, APHIS determined that the vectors and other elements were

disarmed and that the trials 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.

Food or animal feed uses of DNAP's delayed-ripening tomato line

1345-4 may be subject to regulation by the Food and Drug Administration

(FDA) under the authority of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 201 et seq.). FDA's policy statement concerning regulation

of plants derived from new plant varieties was published in the Federal

Register on May 29, 1992 (57 FR 22984-23005).

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 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 DNAP's delayed-ripening tomato line

1345-4 and the availability of APHIS' written decision.

Authority: 7 U.S.C. 150aa-150jj, 151-167, 1622n; 31 U.S.C. 9701;

7 CFR 2.17, 2.51, and 371.2(c).

Done in Washington, DC, this 21st day of September 1994.

Lonnie J. King,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 94-23736 Filed 9-23-94; 8:45 am]

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