[Federal Register Volume 64, Number 55 (Tuesday, March 23, 1999)]
[Notices]
[Pages 13959-13960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7077]
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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. 64, No. 55 / Tuesday, March 23, 1999 /
Notices
[[Page 13959]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 99-010-1]
AgrEvo USA Co.; Extension of Determination of Nonregulated Status
for Corn Genetically Engineered for Male Sterility and Glufosinate
Herbicide Tolerance as a Marker
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 corn transformation event our determination that a corn
transformation event developed by AgrEvo USA Company, which has been
genetically engineered for male sterility and glufosinate herbicide
tolerance as a marker, is no longer considered a regulated article
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: April 22, 1999.
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 to facilitate entry into the
reading room.
FOR FURTHER INFORMATION CONTACT: Dr. James White, Biotechnology and
Biological Analysis, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147,
Riverdale, MD 20737-1236; (301) 734-5940. 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:
Kay.Peterson@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. 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 must include information to
establish the similarity of the antecedent organism and the regulated
article in question.
Background
On December 15, 1998, APHIS received a request for an extension of
a determination of nonregulated status (APHIS No. 98-349-01p) from
AgrEvo USA Company (AgrEvo) of Wilmington, DE, for corn designated as
transformation event MS6 (event MS6), which has been genetically
engineered for male sterility and glufosinate herbicide tolerance as a
marker. The AgrEvo request seeks an extension of a determination of
nonregulated status issued for corn transformation event MS3, the
antecedent organism, in response to APHIS petition number 95-228-01p
(61 FR 9142-9143, March 7, 1996, Docket No. 95-076-2). Based on the
similarity of corn event MS6 to the antecedent organism, AgrEvo
requests a determination that male sterile and glufosinate tolerant
corn event MS6 does not present a plant pest risk and, therefore, is
not a regulated article under APHIS' regulations in 7 CFR part 340.
Analysis
Like the antecedent organism, corn event MS6 contains a barnase
gene derived from Bacillus amyloliquefaciens and a bar gene derived
from Streptomyces hygroscopicus. The barnase gene encodes an enzyme
that inhibits pollen formation and results in male sterility of the
transformed plants. The bar gene encodes a phosphinothricin
acetyltransferase (PAT) enzyme that confers tolerance to the herbicide
glufosinate. Linkage of the barnase gene, which induces male sterility,
with the bar gene, a glufosinate tolerance gene used as a marker,
enables selection of the male sterile line independent of plant growth
stage. Expression of the added genes is controlled in part by gene
sequences derived from the plant pathogens cauliflower mosaic virus and
Agrobacterium tumefaciens. While corn event MS6 contains fragments of
the bla marker gene, it was concluded that the fragments would not
produce an intact protein in any medium. The particle acceleration
method was used to transfer the added genes into the parental corn
inbred line H99.
Corn event MS6 and the antecedent organism were genetically
engineered using the same transformation method, with the same gene
that makes the plants sterile and the same marker gene, and using the
same parental inbred line. Accordingly, we have determined that corn
event MS6 is similar to the antecedent organism in petition 95-228-01p
and, therefore, should no longer be regulated under the regulations in
7 CFR part 340.
The subject corn event has been considered a regulated article
under APHIS' regulations in 7 CFR part 340 because it contains gene
sequences derived from plant pathogens. However, evaluation of field
data reports from field tests of this corn event conducted under APHIS
notifications since 1997 indicates that there were no deleterious
effects on plants, nontarget organisms, or the environment as a result
of its environmental release.
[[Page 13960]]
Determination
Based on an analysis of the data submitted by AgrEvo and a review
of other scientific data and field tests of the subject corn event,
APHIS has determined that corn event MS6: (1) Exhibits no plant
pathogenic properties; (2) is no more likely to become a weed than male
sterile corn 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 corn
event MS6 and any progeny derived from crosses with other corn
varieties will be as safe to grow as corn that is not subject to
regulation under 7 CFR part 340.
Since APHIS has determined that corn event MS6 does not present a
plant pest risk based on its similarity to the antecedent organism,
AgrEvo's corn event MS6 will no longer be 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 corn event or its progeny. However, importation
of corn event MS6 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 (NEPA), as amended (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 corn event MS6 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 17th day of March, 1999.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-7077 Filed 3-23-99; 8:45 am]
BILLING CODE 3410-34-P
