[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.P[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 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

[[Page 38806]]

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