[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]
BILLING CODE 3410-34-P