[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
________________________________________________________________________
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
appearing in this section.
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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.Peterson@usda.gov.
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
