[Federal Register Volume 63, Number 138 (Monday, July 20, 1998)]
[Notices]
[Pages 38805-38806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19228]
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Notices
Federal Register
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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. 63, No. 138 / Monday, July 20, 1998 /
Notices
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 98-067-1]
Monsanto Co.; Receipt of Petition for Determination of
Nonregulated Status for Potato Lines Genetically Engineered for Insect
and Virus Resistance
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 certain potato lines
genetically engineered for resistance to the Colorado potato beetle and
potato virus Y. 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 potato
lines present a plant pest risk.
DATES: Written comments must be received on or before September 18,
1998.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 98-067-1, 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. 98-067-1. 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. David Heron, Biotechnology and
Biological Analysis, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147,
Riverdale, MD 20737-1236; (301) 734-5141. To obtain a copy of the
petition, contact Ms. Kay Peterson at (301) 734-4885; e-mail:
Kay.Peterson@usda.gov.
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 December 5, 1997, APHIS received a petition (APHIS Petition No.
97-339-01p) from Monsanto Company (Monsanto) of St. Louis, MO,
requesting a determination of nonregulated status under 7 CFR part 340
for certain NewLeaf Y potato lines. The subject potato lines
include one line of Russet Burbank (RBMT15-101), two lines of Shepody
(SEMT15-02 and SEMT15-15), and one line of HiLite (HLMT15-46), which
have been genetically engineered for resistance to the Colorado potato
beetle (CPB) and potato virus Y (PVY). The Monsanto petition states
that the subject potato lines should not be regulated by APHIS because
they do not present a plant pest risk.
As described in the petition, all four of the subject
NewLeaf Y potato lines have been genetically engineered to
contain the cry3A gene from Bacillus thuringiensis subsp. tenebrionis
(Btt), which encodes a protein that is insecticidal to CPB, and the PVY
coat protein gene (PVYcp), which imparts resistance to PVY. In addition
to the cry3A gene and the PVYcp gene, these potato lines contain and
express the nptII selectable marker gene, which is used in the initial
stages of plant selection. While the two Shepody lines (SEMT15-02 and
SEMT15-15) and the HiLite line (HLMT15-46) also contain the aad marker
gene, tests indicate that this gene is not expressed in these potato
plants. The subject potato lines were developed through the use of the
Agrobacterium tumefaciens transformation system, and expression of the
introduced genes is controlled in part by gene sequences derived from
the plant pathogens A. tumefaciens and figwort mosaic virus.
The subject potato lines have been considered regulated articles
under the regulations in 7 CFR part 340 because they contain gene
sequences derived from plant pathogens. These potato lines have been
evaluated in field trials conducted since 1995 under APHIS
notifications. In the process of reviewing the notifications for field
trials of the subject potato lines, APHIS determined 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
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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 this
regard, EPA has issued a registration to Monsanto for full
commercialization of the plant pesticide Btt CRY3A delta endotoxin and
the genetic material necessary for its production in potato. Residue
tolerances for pesticides are established by 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 EPA under the FFDCA. In addition to the registration, EPA has
issued exemptions from the requirement of a tolerance for residues of
the subject plant pesticide CRY3A in potatoes, for the NPTII protein as
a plant pesticide inert ingredient in all plants, and for the PVY coat
protein in or on all plants and raw agricultural commodities.
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 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.
Monsanto has completed consultation with FDA on the subject potato
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 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 NewLeaf Y
potato lines RBMT15-101, SEMT15-02, SEMT15-15, and HLMT15-46 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 14th day of July, 1998.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-19228 Filed 7-17-98; 8:45 am]
BILLING CODE 3410-34-P
