[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 
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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.P[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 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