[Federal Register Volume 59, Number 185 (Monday, September 26, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23736]
[[Page Unknown]]
[Federal Register: September 26, 1994]
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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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