Agritope, Inc.; Receipt of Petition for Determination of Nonregulated Status for Cantaloupe Genetically Engineered for Altered Fruit Ripening

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 99-003-1]

Agritope, Inc.; Receipt of Petition for Determination of

Nonregulated Status for Cantaloupe Genetically Engineered for Altered

Fruit Ripening

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 Agritope, Inc., seeking

a determination of nonregulated status for certain cantaloupe lines,

which have been genetically engineered for altered 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 these cantaloupe lines present a plant pest

risk.

DATES: Written comments must be received on or before May 17, 1999.

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

Docket No. 99-003-1, 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. 99-003-1. 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 facilitate entry into the reading room.

FOR FURTHER INFORMATION CONTACT: Dr. Sivramiah Shantharam,

Biotechnology and Biological Analysis, PPQ, APHIS, Suite 4C03, 4700

River Road Unit 133, Riverdale, MD 20737-1236; (301) 734-4882. To

obtain a copy of the petition, contact Ms. Kay Peterson at (301) 734-

4885; e-mail: Kay.P[email protected].

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 December 16, 1998, APHIS received a petition (APHIS Petition No.

98-350-01p) from Agritope, Inc., (Agritope) of Portland, OR, requesting

a determination of nonregulated status under 7 CFR part 340 for

cantaloupe (Cucumis melo L.) lines designated as A and B, which have

been genetically engineered for altered fruit ripening. The Agritope

petition states that the subject cantaloupe lines should not be

regulated by APHIS because they do not present a plant pest risk.

As described in the petition, cantaloupe lines A and B have been

genetically engineered to contain a SAMase gene derived from

Escherichia coli bacteriophage T3. The SAMase gene encodes an S-

adenosylmethionine hydrolase enzyme capable of degrading and thus

reducing S-adenosyl- methionine (SAM). The reduction of SAM results in

less ethylene production during fruit ripening in cantaloupe lines A

and B and a corresponding increase in the uniformity of ripening in the

field.

The subject cantaloupe lines also contain the nptII marker gene

used in the early stages of plant transformation. Expression of the

added genes is controlled in part by gene sequences derived from the

plant pathogen Agrobacterium tumefaciens and the A. tumefaciens method

was used to transfer the added genes into the parental inbred

cantaloupe lines.

Cantaloupe lines A and B have been considered regulated articles

under the regulations in 7 CFR part 340 because they contain gene

sequences from a plant pathogen. The subject cantaloupe lines have been

field tested in the United States since 1997 under APHIS permits and

notifications. In the process of reviewing the applications for field

trials of this cantaloupe, APHIS determined 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 Food, Drug, and Cosmetic Act (FFDCA), as

amended (21 U.S.C. 301 et seq.), and provides guidance to industry on

the

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scientific considerations associated with the development of foods

derived from new plant varieties, including those plants developed

through the techniques of genetic engineering. Agritope has begun

consultation with FDA on the subject cantaloupe lines.

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 from the individual listed under FOR FURTHER INFORMATION

CONTACT.

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 cantaloupe lines A and B

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 10th day of March 1999.

Joan M. Arnoldi,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 99-6345 Filed 3-15-99; 8:45 am]

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