[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.
[[Page 63313]]
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]
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