[Federal Register Volume 62, Number 229 (Friday, November 28, 1997)]
[Notices]
[Pages 63312-63313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31222]



[[Page 63312]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 97-114-1]


Monsanto Co.; Receipt of Petition for Determination of 
Nonregulated Status for Genetically Engineered Tomato

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 Monsanto Company 
seeking a determination of nonregulated status for a tomato line 
designated as 5345, which has been genetically engineered for 
resistance to certain lepidopteran insect pests. 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 this tomato line presents a plant pest risk.

DATES: Written comments must be received on or before January 27, 1998.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 97-114-1, 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. 97-114-1. 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 Evaluation, BSS, PPQ, APHIS, Suite 5B05, 4700 River Road 
Unit 147, Riverdale, MD 20737-1236; (301) 734-4882. To obtain a copy of 
the petition, contact Ms. Kay Peterson at (301) 734-4885; e-mail: 
[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 October 14, 1997, APHIS received a petition (APHIS Petition No. 
97-287-01p) from Monsanto Company (Monsanto) of St. Louis, MO, 
requesting a determination of nonregulated status under 7 CFR part 340 
for a genetically engineered, insect-resistant tomato line designated 
as 5345. The petition states that the subject tomato line should not be 
regulated by APHIS because it does not present a plant pest risk.
    As described in the petition, tomato line 5345 has been genetically 
engineered to express a CryIA(c) insect control protein derived from 
the common soil bacterium Bacillus thuringiensis subsp. kurstaki HD-73 
(Btk). The petitioner states that expression of the Btk delta-endotoxin 
protein protects the subject tomato line from damage caused by certain 
lepidopteran insect pests. Tomato line 5345 also expresses the NPTII 
protein which serves as a selectable marker in the plant transformation 
process. While the subject tomato line contains the aad gene, tests 
indicate that the AAD protein, which serves as a selectable marker in 
the laboratory prior to plant transformation, is not expressed in the 
plant. The added genes were introduced into the UC82B parental tomato 
plants by the Agrobacterium tumefaciens transformation system, and 
their expression is controlled in part by gene sequences derived from 
the plant pathogens cauliflower mosaic virus and A. tumefaciens.
    The subject tomato line is currently considered a regulated article 
under the regulations in 7 CFR part 340 because it contains gene 
sequences derived from plant pathogenic sources. Tomato line 5345 has 
been evaluated in field trials conducted since 1994 under APHIS 
notifications. In the process of reviewing the notifications for field 
trials of this tomato line, APHIS determined that the vectors and other 
elements were disarmed and 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 U.S. Environmental Protection Agency (EPA) is responsible for 
the regulation of pesticides under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA 
requires that all pesticides, including insecticides, be registered 
prior to distribution or sale, unless exempt by EPA regulation. In 
cases in which the genetically modified plant allows for a new or 
different use pattern for a pesticide, EPA must approve the new or 
different use. Residue tolerances for pesticides are established by the 
EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), as amended 
(21 U.S.C. 301 et seq.), and the Food and Drug Administration (FDA) 
enforces tolerances set by the EPA under the FFDCA. The EPA has granted 
exemptions from the requirement of a tolerance for residues of the 
CryIA(c) and NPTII proteins and the genetic material necessary for 
their production in all plants.
    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.

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    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 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 Monsanto's insect-resistant tomato 
line 5345 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 20th day of November 1997.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-31222 Filed 11-26-97; 8:45 am]
BILLING CODE 3410-34-P