[Federal Register Volume 62, Number 189 (Tuesday, September 30, 1997)]
[Notices]
[Pages 51081-51082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25858]



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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 97-091-1]


AgrEvo USA Co.; Receipt of Petition for Determination of 
Nonregulated Status for Canola Genetically Engineered for Glufosinate 
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 canola designated as 
Transformation Event T45, which has been genetically engineered for 
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 
this canola presents a plant pest risk.

DATES: Written comments must be received on or before December 1, 1997.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 97-091-1, 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. 97-091-1. 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 Lackey, Biotechnology 
Evaluation, BSS, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-7612. To obtain a copy of the 
petition, contact Ms. Kay Peterson at (301) 734-4885; e-mail: 
[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 July 24, 1997, APHIS received a petition (APHIS Petition No. 97-
205-01p) 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 Transformation Event T45 (event T45), 
which has been genetically engineered for tolerance to the herbicide 
glufosinate. The AgrEvo petition states that the subject canola should 
not be regulated by APHIS because it does not present a plant pest 
risk.
    As described in the petition, event T45 canola has been genetically 
engineered to contain the pat gene derived from Streptomyces 
viridochromogenes. The pat gene encodes the enzyme phosphinothricin-N-
acetyltransferase (PAT), which confers tolerance to the herbicide 
glufosinate. Expression of the pat gene is controlled by the 35S 
promoter and terminator derived from the plant pathogen cauliflower 
mosaic virus. The Agrobacterium tumefaciens method was used to transfer 
the added genes into the parental cultivar B. napus var. AC EXCEL.
    Event T45 canola has been considered a regulated article under the 
regulations in 7 CFR part 340 because it contains gene sequences from 
plant pests. The subject canola has been field tested in Canada since 
1995, and in the U.S. since 1996 under APHIS permits. In the process of 
reviewing the permit applications for field trials of this canola, 
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. Event T45 canola has been 
approved for commercial sale 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.
    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 begun consultation with FDA on the subject canola.

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    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 event T45 canola, 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 24th day of September 1997.
Terry L. Medley,
Aministrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-25858 Filed 9-29-97; 8:45 am]
BILLING CODE 3410-34-P