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glufosinate-ammonium (Rely, Finale) Extension of Determination of Nonregulated Status 5/98

[Federal Register: May 7, 1998 (Volume 63, Number 88)]
[Notices]               
[Page 25195-25196]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my98-30]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 98-032-1]

 
AgrEvo USA Co.; Extension of Determination of Nonregulated Status 
to Soybean 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 of our decision to extend to one 
additional soybean line our determination that certain soybean lines 
developed by AgrEvo USA Company, which have been genetically engineered 
for glufosinate herbicide tolerance, are no longer considered regulated 
articles under our regulations governing the introduction of certain 
genetically engineered organisms. Our decision is based on our 
evaluation of data submitted by AgrEvo USA Company in its request for 
an extension of a determination of nonregulated status and an analysis 
of other scientific data. This notice also announces the availability 
of an environmental assessment and finding of no significant impact.

EFFECTIVE DATE: June 8, 1998.

ADDRESSES: The extension request and an environmental assessment and 
finding of no significant impact 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 to inspect those documents are asked to call 
in advance of visiting at (202) 690-2817.

FOR FURTHER INFORMATION CONTACT: Dr. Sivramiah Shantharam, 
Biotechnology and Biological Analysis, PPQ, APHIS, 4700 River Road Unit 
147, Riverdale, MD 20737-1236; (301) 734-4882. To obtain a copy of the 
extension request or the environmental assessment and finding of no 
significant impact, 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

[[Page 25196]]

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. Further, the regulations in Sec. 340.6(e)(2) provide that 
a person may request that APHIS extend a determination of nonregulated 
status to other organisms. Such a request shall include information to 
establish the similarity of the antecedent organism and the regulated 
article in question.

Background

    On January 14, 1998, APHIS received a request for an extension of a 
determination of nonregulated status (APHIS No. 98-014-01p) from AgrEvo 
USA Company (AgrEvo) of Wilmington, DE, for a soybean line designated 
as transformation event A5547-127 (event A5547-127), which has been 
genetically engineered for resistance, or tolerance, to the herbicide 
glufosinate. The AgrEvo request seeks an extension of a determination 
of nonregulated status that was issued for certain lines of glufosinate 
tolerant soybean (antecedent organisms) in response to APHIS petition 
number 96-068-01p (61 FR 42581-42582, August 16, 1996, Docket No. 96-
019-2). Based on the similarity of event A5547-127 to the antecedent 
organisms, AgrEvo requests a determination that glufosinate tolerant 
soybean event A5547-127 does not present a plant pest risk and, 
therefore, is not a regulated article under APHIS' regulations in 7 CFR 
part 340.

Analysis

    Event A5547-127 soybean contains 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 the plant pathogen cauliflower mosaic virus. While the 
subject soybean event contains fragments of the bla marker gene, tests 
indicate this gene is not expressed in the plant. The particle 
acceleration method was used to transfer the added genes into the 
parental Glycine max A5547 cultivar. Event A5547-127 soybean was 
transformed with the same plasmid vector and in the same manner as 
certain antecedent organisms described in APHIS petition number 96-068-
01p, and differs from them only in the copy number and extent of 
integrated DNA.
    The subject soybean line has been considered a regulated article 
under APHIS' regulations in 7 CFR part 340 because it contains gene 
sequences derived from a plant pathogen. However, evaluation of field 
data reports from field tests of this soybean conducted under APHIS 
notifications since 1996 indicates that there were no deleterious 
effects on plants, nontarget organisms, or the environment as a result 
of its environmental release.

Determination

    Based on an analysis of the data submitted by AgrEvo and a review 
of other scientific data and field tests of the subject soybean line, 
APHIS has determined that event A5547-127 soybean: (1) Exhibits no 
plant pathogenic properties; (2) is no more likely to become a weed 
than soybean lines developed by traditional breeding techniques; (3) is 
unlikely to increase the weediness potential for any other cultivated 
or wild species with which it can interbreed; (4) will not cause damage 
to raw or processed agricultural commodities; and (5) will not harm 
threatened or endangered species or other organisms, such as bees, that 
are beneficial to agriculture. Therefore, APHIS has concluded that the 
subject soybean line and any progeny derived from crosses with other 
soybean varieties will be as safe to grow as soybeans in traditional 
breeding programs that are not subject to regulation under 7 CFR part 
340.
    The effect of this determination is that AgrEvo's event A5547-127 
soybean is no longer considered a regulated article under APHIS' 
regulations in 7 CFR part 340. Therefore, the requirements pertaining 
to regulated articles under those regulations no longer apply to the 
field testing, importation, or interstate movement of the subject 
soybean line or its progeny. However, importation of the subject 
soybean line or seeds capable of propagation are still subject to the 
restrictions found in APHIS' foreign quarantine notices in 7 CFR part 
319.

National Environmental Policy Act

    An environmental assessment (EA) has been prepared to examine the 
potential environmental impacts associated with this determination. The 
EA was prepared in accordance with: (1) The National Environmental 
Policy Act of 1969, as amended (NEPA) (42 U.S.C. 4321 et seq.), (2) 
regulations of the Council on Environmental Quality for implementing 
the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA 
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA 
Implementing Procedures (7 CFR part 372). Based on that EA, APHIS has 
reached a finding of no significant impact (FONSI) with regard to its 
determination that AgrEvo's event A5547-127 soybean and lines developed 
from it are no longer regulated articles under its regulations in 7 CFR 
part 340. Copies of the EA and the FONSI are available upon request 
from the individual listed under FOR FURTHER INFORMATION CONTACT.

    Done in Washington, DC, this 1st day of May 1998.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-12126 Filed 5-6-98; 8:45 am]
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