[Federal Register Volume 63, Number 200 (Friday, October 16, 1998)]
[Notices]
[Pages 55573-55574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27828]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 98-089-1]


Monsanto Co.; Receipt of Petition for Determination of 
Nonregulated Status for Canola Genetically Engineered for Glyphosate 
Herbicide Tolerance

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 canola line 
designated as RT73, which has been genetically engineered for tolerance 
to the herbicide glyphosate. 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 canola 
line presents a plant pest risk.

DATES: Written comments must be received on or before December 15, 
1998.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 98-089-1, 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. 98-089-1. 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. Subhash Gupta, Biotechnology and 
Biological Analysis, PPQ, APHIS, Suite 4C46, 4700 River Road Unit 133, 
Riverdale, MD 20737-1236; (301) 734-8761. 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 August 4, 1998, APHIS received a petition (APHIS Petition No. 
98-216-01p) from Monsanto Company (Monsanto) of St. Louis, MO, 
(Monsanto) requesting a determination of nonregulated status under 7 
CFR part 340 for a canola (Brassica napus L.) line designated as RT73, 
which has been genetically engineered for tolerance to the herbicide 
glyphosate. The Monsanto petition states that the subject canola line 
should not be regulated by APHIS because it does not present a plant 
pest risk.
    As described in the petition, canola line RT73 has been genetically 
engineered to express a CP4 EPSPS gene derived from Agrobacterium sp. 
strain CP4, and a gox gene derived from Ochrobactrum anthropi strain 
LBAA. The CP4 EPSPS gene encodes a 5-enolpyruvylshikimate-3-phosphate 
synthase (EPSPS) protein, and the gox gene encodes a glyphosate 
oxidoreductase (GOX) protein. The EPSPS and GOX proteins confer 
tolerance to the herbicide glyphosate. The Agrobacterium tumefaciens 
method was used to transfer the added genes into the parental canola 
Westar variety plants, and expression of the added genes is controlled 
in part by gene sequences derived from the plant pathogen figwort 
mosaic virus.

[[Page 55574]]

    Canola line RT73 has been considered a regulated article under the 
regulations in 7 CFR part 340 because it contains gene sequences from 
plant pathogens. The subject canola line has been field tested since 
1996 under APHIS permits. In the process of reviewing the permit 
applications for field trials of this canola 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 herbicides, be registered prior 
to distribution or sale, unless exempt by EPA regulation. In cases in 
which genetically modified plants allow for a new use of an herbicide 
or involve a different use pattern for the herbicide, EPA must approve 
the new or different use. Accordingly, a submission has been made to 
EPA for registration of the herbicide glyphosate for use on canola. 
When the use of the herbicide on the genetically modified plant would 
result in an increase in the residues of the herbicide in a food or 
feed crop for which the herbicide is currently registered, or in new 
residues in a crop for which the herbicide is not currently registered, 
establishment of a new tolerance or a revision of the existing 
tolerance would be required. 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.
    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 canola 
line.
    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 the Monsanto RT73 canola line 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 9th day of October 1998.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-27828 Filed 10-15-98; 8:45 am]
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