[Federal Register Volume 63, Number 235 (Tuesday, December 8, 1998)]
[Notices]
[Pages 67643-67644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32519]


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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 
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  Federal Register / Vol. 63, No. 235 / Tuesday, December 8, 1998 / 
Notices  

[[Page 67643]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 98-114-1]


AgrEvo USA Co.; Receipt of Petition for Determination of 
Nonregulated Status for Canola Genetically Engineered for Male 
Sterility, Fertility Restoration, and Glufosinate 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 AgrEvo USA Company 
seeking a determination of nonregulated status for certain canola 
transformation events, which have been genetically engineered for male 
sterility, fertility restoration, and tolerance to the herbicide 
glufosinate. 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 canola 
transformation events present a plant pest risk.

DATES: Written comments must be received on or before February 8, 1999.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 98-114-1, 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. 98-114-1. A copy of the 
petition and any comments received may be inspected at USDA, room 1141, 
South Building, 14thStreet 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. Susan Koehler, Biotechnology and 
Biological Analysis, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-4886. 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 October 5, 1998, APHIS received a petition (APHIS Petition No. 
98-278-01p) from AgrEvo USA Company (AgrEvo) of Wilmington, DE, 
requesting a determination of nonregulated status under 7 CFR part 340 
for canola (Brassica napus L.) designated as In Vigor Hybrid 
Canola Transformation Events (transformation events) MS8 and RF3, and 
their hybrid combination MS8/RF3. The subject transformation events 
have been genetically engineered for male sterility (MS8), fertility 
restoration (RF3), and tolerance to the herbicide glufosinate (both MS8 
and RF3), to enable the production of pure hybrid canola varieties by 
the use of a pollination control system. AgrEvo's petition states that 
the subject canola transformation events should not be regulated by 
APHIS because they do not present a plant pest risk.
    As described in the petition, these canola transformation events 
have been genetically engineered to contain a barnase gene (MS8) for 
male sterility or the barstar gene (RF3) for fertility restoration. The 
barnase gene expresses a ribonuclease that blocks pollen development 
and results in a male sterile plant, while the barstar gene encodes a 
specific inhibitor of this ribonuclease and restores fertility. The 
barnase and barstar genes were derived from Bacillus amyloliquefaciens, 
and are linked in the subject transformation events to the bar gene 
derived from Streptomyces hygroscopicus. The bar gene encodes the 
enzyme phosphinothricin-N-acetyltransferase (PAT), which confers 
tolerance to the herbicide glufosinate. The herbicide tolerance trait 
allows for selection of plants carrying the linked genes for 
pollination control during breeding and for tolerance to the herbicide 
during commercial cultivation. Expression of the added genes is 
controlled in part by gene sequences derived from Arabidopsis thaliana, 
Nicotiana tabacum, and the plant pathogen Agrobacterium tumefaciens. 
The A. tumefaciens method was used to transfer the added genes into the 
parental canola variety, Drakkar.
    Canola transformation events MS8, RF3, and their hybrid combination 
MS8/RF3 have been considered regulated articles under the regulations 
in 7 CFR part 340 because they contain gene sequences from a plant 
pathogen. These canola transformation events have been field tested in 
Canada since 1994, in Europe since 1995, and in the U. S. since 1997 
under APHIS permits and notifications. In the process of reviewing the 
permit applications and notifications for field trials of these canola 
transformation events, 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. Canola 
transformation events MS8, RF3, and their hybrid combination MS8/RF3 
were approved in 1996 by Agriculture and Agri-Food Canada for 
unconfined environmental release and use as livestock feed in Canada, 
and in 1997, Health Canada

[[Page 67644]]

approved oil from the subject transformation events for sale as human 
food in Canada.
    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. 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. Accordingly, AgrEvo has submitted to EPA 
both registration and tolerance exemption applications for glufosinate 
use on canola.
    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. AgrEvo 
has completed consultation with FDA on the subject canola 
transformation events.
    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 AgrEvo's canola transformation 
events MS8, RF3, and their hybrid combination MS8/RF3, 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 2nd day of December 1998.
Joan M. Arnoldi,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-32519 Filed 12-7-98; 8:45 am]
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