[Federal Register Volume 61, Number 83 (Monday, April 29, 1996)]
[Notices]
[Pages 18718-18719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10462]



 ========================================================================
 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 
 appearing in this section.
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  Federal Register / Vol. 61, No. 83 / Monday, April 29, 1996 / 
Notices  

[[Page 18718]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 96-019-1]


AgrEvo USA Company; Receipt of Petition for Determination of 
Nonregulated Status for Soybeans 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 certain soybeans 
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 these soybeans present a plant pest risk.

DATES: Written comments must be received on or before June 28, 1996.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 96-019-1, 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. 96-019-1. 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.

FOR FURTHER INFORMATION CONTACT: Dr. Sivramiah Shantharam, 
Biotechnology Permits, BBEP, APHIS, Suite 5B05, 4700 River Road Unit 
147, Riverdale, MD 20737-1237; (301) 734-7612. To obtain a copy of the 
petition, contact Ms. Kay Peterson at (301) 734-7612; 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 March 8, 1996, APHIS received a petition (APHIS Petition No. 96-
068-01p) from AgrEvo USA Company (AgrEvo) of Wilmington, DE, requesting 
a determination of nonregulated status under 7 CFR part 340 for 
soybeans designated as Glufosinate Resistant Soybean (GRS) 
Transformation Events W62, W98, A2704-12, A2704-21, and A5547-35 that 
have been genetically engineered for resistance, or tolerance, to the 
herbicide glufosinate. The AgrEvo petition states that the subject GRS 
transformation events should not be regulated by APHIS because they do 
not present a plant pest risk.
    As described in the petition, GRS transformation events W62 and W98 
have been genetically engineered to contain the bar gene derived from 
Streptomyces hygroscopicus and the gus gene derived from Escherichia 
coli. The bar gene encodes the enzyme phosphinothricin-N-
acetyltransferase (PAT), which confers tolerance to glufosinate, and 
the gus gene encodes the enzyme -glucuronidase, which is 
useful as a selectable marker in the transformation process. Expression 
of these added genes is controlled in part by gene sequences from the 
plant pests Agrobacterium tumefaciens, alfalfa mosaic virus (AMV), and 
cauliflower mosaic virus (CaMV). GRS transformation events A2704-12, 
A2704-21, and A5547-35 contain a synthetic version of the pat gene 
derived from Streptomyces viridochromogenes, which encodes the PAT 
enzyme and confers tolerance to glufosinate. Expression of the 
synthetic pat gene is controlled by a 35S promoter and terminator 
derived from CaMV. The particle acceleration method was used to 
transfer the added genes into the parental soybean cultivars.
    GRS transformation events W62, W98, A2704-12, A2704-21, and A5547-
35 have been considered regulated articles under the regulations in 7 
CFR part 340 because they contain gene sequences from the plant 
pathogens mentioned above. GRS transformation events W62 and W98 have 
been field tested since 1990 under APHIS permits or notifications, and 
GRS transformation events A2704-12, A2704-21, and A5547-35 were field 
tested in 1995 under APHIS notifications. In the process of reviewing 
the applications for field trials of the subject GRS 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.
    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

[[Page 18719]]

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) (21 U.S.C. 201 et seq.), and the 
Food and Drug Administration (FDA) enforces tolerances set by EPA under 
the FFDCA. Currently, glufosinate is not registered for use on 
soybeans.
    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.
    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 GRS transformation events 
W62, W98, A2704-12, A2704-21, and A5547-35 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 23rd day of April 1996.
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-10462 Filed 4-26-96; 8:45 am]
BILLING CODE 3410-34-P