[Federal Register Volume 64, Number 50 (Tuesday, March 16, 1999)]
[Notices]
[Pages 12926-12927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6345]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
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  Federal Register / Vol. 64, No. 50 / Tuesday, March 16, 1999 / 
Notices  

[[Page 12926]]


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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

[[Page 12927]]

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]
BILLING CODE 3410-34-P