[Federal Register Volume 63, Number 204 (Thursday, October 22, 1998)]
[Notices]
[Pages 56603-56604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28283]
========================================================================
Notices
Federal Register
________________________________________________________________________
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.
========================================================================
Federal Register / Vol. 63, No. 204 / Thursday, October 22, 1998 /
Notices
[[Page 56603]]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 98-100-1]
AgrEvo USA Co.; Extension of Determination of Nonregulated Status
for Soybean Genetically Engineered for Glufosinate Herbicide Tolerance
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
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: November 23, 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:
[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. 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 August 26, 1998, APHIS received a request for an extension of a
determination of nonregulated status (APHIS No. 98-238-01p) from AgrEvo
USA Company (AgrEvo) of Wilmington, DE, for a soybean line designated
as transformation event GU262 (event GU262), 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 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 GU262 soybean to the antecedent
organisms, AgrEvo requests a determination that glufosinate tolerant
soybean event GU262 does not present a plant pest risk and, therefore,
is not a regulated article under APHIS' regulations in 7 CFR part 340.
Analysis
Event GU262 soybean contains a synthetic version of the pat gene
derived from Streptomyces viridochromogenes. The pat gene encodes a
phosphinothricin acetyltransferase (PAT) enzyme which 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 line 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 PH12 cultivar. Event GU262 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. Accordingly, we have determined that the event GU262
soybean line is similar to the antecedent organisms in petition 96-068-
01p and therefore does not need to be regulated.
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 line 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 GU262 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
[[Page 56604]]
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 that are not
subject to regulation under 7 CFR part 340.
Since APHIS has determined that event GU262 soybean does not pose a
plant pest risk and is similar to the antecedent organisms, AgrEvo's
event GU262 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 GU262 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 16th day of October 1998.
Joan M. Arnoldi,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-28283 Filed 10-21-98; 8:45 am]
BILLING CODE 3410-34-P
