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glufosinate-ammonium (Rely, Finale) Receipt of Petition 2/98

  


[Federal Register: February 6, 1998 (Volume 63, Number 25)]
[Notices]               
[Page 6148-6149]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06fe98-35]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 97-130-1]

 
AgrEvo USA Co.; Receipt of Petition for Determination of 
Nonregulated Status for Sugar Beet Genetically Engineered for 
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 sugar beet 
designated as Transformation Event T120-7, 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 sugar beet presents a plant pest risk.

DATES: Written comments must be received on or before April 7, 1998.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 97-130-1, 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. 97-130-1. 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. Ved Malik, Biotechnology and 
Biological Analysis, 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: 
mkpeterson@aphis.usda.gov.

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 2, 1997, APHIS received a petition (APHIS Petition No. 
97-336-01p) from AgrEvo USA Company (AgrEvo) of Wilmington, DE, 
requesting a determination of nonregulated status under 7 CFR part 340 
for sugar beet (Beta vulgaris L.) designated as Transformation Event 
T120-7 (event T120-7), which has been genetically engineered for 
tolerance to the herbicide glufosinate. The AgrEvo petition states that 
the subject sugar beet should not be regulated by APHIS because it does 
not present a plant pest risk.
    As described in the petition, event T120-7 sugar beet has been 
genetically engineered to contain a synthetic version of the pat gene 
derived from Streptomyces viridochromogenes. The pat gene encodes the 
enzyme phosphinothricin acetyltransferase (PAT), which confers 
tolerance to the herbicide glufosinate. Expression of the pat gene is 
controlled by 35S promoter and terminator sequences derived from the 
plant pathogen cauliflower mosaic virus. Event T120-7 sugar beet also 
contains the aph(3')II or nptII marker gene used in plant 
transformation. Expression of the nptII gene is controlled by gene 
sequences derived from the plant pathogen Agrobacterium tumefaciens, 
and analysis indicates that the NPTII protein is expressed in certain 
parts of the subject plants. The A. tumefaciens method was used to 
transfer the added genes into the parental sugar beet line.
    Event T120-7 sugar beet 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 has been field 
tested in the U.S. since 1994 under APHIS permits. In the process of 
reviewing the permit applications for field trials of this sugar beet, 
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

[[Page 6149]]

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 
glufosinate 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. AgrEvo 
has begun consultation with FDA on the subject sugar beet.
    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 T120-7 sugar beet 
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 February 1998.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-3048 Filed 2-5-98; 8:45 am]
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