[Federal Register Volume 60, Number 52 (Friday, March 17, 1995)]
[Notices]
[Pages 14413-14414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6651]



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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. 60, No. 52 / Friday, March 17, 1995 / 
Notices
[[Page 14413]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 95-016-1]


Receipt of Petition for Determination of Nonregulated Status for 
Genetically Engineered Tomato Lines

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 Zeneca Plant Science 
and Petoseed Company, Inc., seeking a determination of nonregulated 
status for tomato lines designated as B, Da, and F that have been 
genetically engineered for suppressed polygalacturonase enzyme 
activity. 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 tomato 
lines present a plant pest risk.

DATES: Written comments must be received on or before May 16, 1995.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 95-016-1, Animal and Plant Health Inspection Service, Policy 
and Program Development, Regulatory Analysis and Development, 4700 
River Road Unit 118, Riverdale, MD 20737-1228. Please state that your 
comments refer to Docket No. 95-016-01. 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.

FOR FURTHER INFORMATION CONTACT: Dr. Subhash Gupta, Biotechnologist, 
Animal and Plant Health Inspection Service, Biotechnology, Biologics, 
and Environmental Protection, Biotechnology Permits, 4700 River Road 
Unit 147, Riverdale, MD 20737-1228; (301) 734-7612. To obtain a copy of 
the petition, contact Ms. Kay Peterson at (301) 734-7612.

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 February 7, 1995, APHIS received a petition (APHIS Petition No. 
94-290-01p) from Zeneca Plant Science of Wilmington, DE, and Petoseed 
Company, Inc., of Woodland, CA, (Zeneca/Petoseed) requesting a 
determination of nonregulated status under 7 CFR part 340 for modified 
T7 processing tomato inbred lines designated as B, Da, and F that have 
been genetically engineered for suppressed polygalacturonase (PG) 
enzyme activity. As described in the petition, tomato lines B, Da, and 
F have been developed from an unmodified proprietary inbred tomato line 
coded as T7, genetically engineered to contain a fragment of the tomato 
PG gene in the sense or antisense orientation. The PG enzyme is 
responsible for the breakdown of pectin molecules in the cell walls of 
tomato fruit during ripening. The inhibition of the PG enzyme resulting 
from the transcription of the PG gene fragment results in an increased 
thickness of the tomato, which is a desired characteristic in 
processing tomatoes.
    The PG gene fragment in the subject tomato lines is regulated by 
the 35S promoter from the plant pathogen cauliflower mosaic virus. 
Tomato lines B, Da, and F were transformed through the use of disarmed 
vectors from a common soil-borne bacterium, the plant pathogen 
Agrobacterium tumefaciens. The subject tomato lines also contain the 
bacterial neomycin phosphotransferase (nptII) gene that is used as a 
selectable marker.
    The subject tomato lines are currently considered regulated 
articles under the regulations in 7 CFR part 340 because they contain 
gene sequences (vectors, promoters, and terminators) derived from plant 
pathogens. Tomato lines B, Da, and F were evaluated in field trials 
conducted under APHIS permits in l991, 1992, and 1993, and under APHIS 
notifications in 1994. In the process of reviewing the applications for 
those field trials, APHIS determined that the vectors and other 
elements were disarmed and that the trials, which were conducted under 
conditions of reproductive confinement, 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 the subject tomato lines may be subject 
to regulation by the Food and Drug Administration (FDA) under the 
[[Page 14414]] authority of the Federal Food, Drug, and Cosmetic Act 
(FFDCA) (21 U.S.C. 301 et seq.). The 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 the FDA's authority for ensuring food 
safety under the FFDCA, and provides guidance to industry on the 
scientific considerations associated with the development of foods 
derived from new plant varieties, including those plants developed 
through the techniques of genetic engineering. Zeneca has notified the 
FDA that it has completed its food safety and nutritional assessment 
for the subject tomato 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 (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 
petitioners, 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 Zeneca/Petoseed's tomato 
lines B, Da, and F 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 2.17, 2.51, and 371.2(c).

    Done in Washington, DC, this 13th day of March 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-6651 Filed 3-16-95; 8:45 am]
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