[Federal Register Volume 63, Number 161 (Thursday, August 20, 1998)]
[Notices]
[Pages 44604-44605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22455]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 98-079-1]


Novartis Seeds and Monsanto Co.; Receipt of Petition for 
Determination of Nonregulated Status for Sugar Beet 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 Novartis Seeds and 
Monsanto Company seeking a determination of nonregulated status for a 
sugar beet line designated as GTSB77, 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 sugar beet line presents a plant pest risk.

DATES: Written comments must be received on or before October 19, 1998.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 98-079-1, 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. 98-079-1. 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. James White, Biotechnology and 
Biological Analysis, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-5940. 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 June 22, 1998, APHIS received a petition (APHIS Petition No. 98-
173-01p) from Novartis Seeds (Novartis) of Research Triangle Park, NC, 
and Monsanto Company (Monsanto) of St. Louis, MO, (Novartis/Monsanto) 
requesting a determination of nonregulated status under 7 CFR part 340 
for a sugar beet (Beta vulgaris L.) line designated as GTSB77, which 
has been genetically engineered for tolerance to the herbicide 
glyphosate. The Novartis/Monsanto petition states that the subject 
sugar beet line should not be regulated by APHIS because it does not 
present a plant pest risk.
    As described in the petition, GTSB77 has been genetically 
engineered to express an enolpyruvylshikimate-3-phosphate synthase 
(EPSPS) enzyme derived from Agrobacterium sp. strain CP4 (CP4 EPSPS), 
and the b-D-glucuronidase (GUS) protein from Escherichia coli. The CP4 
EPSPS protein confers tolerance to the herbicide glyphosate, and the 
GUS protein serves as a marker in the plant transformation process. The 
subject sugar beet line also expresses a novel protein known as 34550, 
which has no known biological activity, and was apparently created when 
a truncated glyphosate oxidoreductase (gox) gene fused to sugar beet 
DNA. The Agrobacterium tumefaciens method was used to transfer the 
added genes into the parental sugar beet proprietary line A1012, and 
expression of the added genes is controlled in part by gene sequences 
derived from the plant pathogens figwort mosaic virus and cauliflower 
mosaic virus.
    The GTSB77 line has been considered a regulated article under the 
regulations in 7 CFR part 340 because it contains gene sequences from 
plant pathogens. The subject sugar beet line has been field tested 
since 1996 under APHIS permits and notifications. In the process of 
reviewing the permit applications and notifications for field trials of 
this sugar beet 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

[[Page 44605]]

approve the new or different use. Accordingly, a submission has been 
made to EPA for registration of the herbicide glyphosate for use on 
sugar beet. 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. 
Novartis and Monsanto have begun consultation with FDA on the subject 
sugar beet 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 Novartis/Monsanto GTSB77 sugar 
beet 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 13th day of August, 1998.
Joan M. Arnoldi,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-22455 Filed 8-19-98; 8:45 am]
BILLING CODE 3410-34-P