[Federal Register Volume 67, Number 226 (Friday, November 22, 2002)]
[Notices]
[Pages 70392-70393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-29754]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 01-100-2]


Aventis CropScience; Extension of Determination of Nonregulated 
Status for Canola Genetically Engineered for Male Sterility, Fertility 
Restoration, and 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 
additional canola events our determination that certain canola events 
developed by Aventis CropScience, which have been genetically 
engineered for male sterility, fertility restoration, and tolerance to 
the herbicide glufosinate, 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 Aventis CropScience in its request for an extension of a 
determination of nonregulated status, an analysis of other scientific 
data, and a comment received from the public in response to a previous 
notice. This notice also announces the availability of our finding of 
no significant impact.

EFFECTIVE DATE: December 23, 2002.

ADDRESSES: You may read the extension request, the environmental 
assessment and finding of no significant impact, and the comment 
received in our reading room. The reading room is located in room 1141 
of the USDA South Building, 14th Street and Independence Avenue SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. James White, Biotechnology 
Regulatory Services, APHIS, Suite 5B05, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-5490. 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 must include 
information to establish the similarity of the antecedent organism and 
the regulated article in question.

Background

    On July 25, 2001, APHIS received a request for an extension of a 
determination of nonregulated status (APHIS No. 01-206-01p) from 
Aventis CropScience (Aventis) of Research Triangle Park, NC, for canola 
(Brassica napus L.) transformation events designated as MS1 and RF1 and 
RF2, which have been genetically engineered for male sterility (MS1), 
fertility restoration (RF1 and RF2), and tolerance

[[Page 70393]]

to the herbicide glufosinate (MS1, RF1, and RF2). Aventis requested an 
extension of a determination of nonregulated status issued in response 
to APHIS petition number 98-278-01p for male sterile canola 
transformation event MS8 and fertility restoration canola 
transformation event RF3, the antecedent organisms (see 64 FR 15337-
15338, Docket No. 98-114-2, published March 31, 1999), which are also 
tolerant to the herbicide glufosinate. Based on the similarity of 
canola events MS1 and RF1 and RF2 to the antecedent organisms, Aventis 
requested a determination that MS1 and RF1 and RF2 do not present a 
plant pest risk and, therefore, are not regulated articles under APHIS' 
regulations in 7 CFR part 340.
    On February 25, 2002, APHIS published a notice in the Federal 
Register (67 FR 8509-8510, Docket No. 01-100-1), announcing that an 
environmental assessment (EA) for the Aventis extension request had 
been prepared and was available for public comment. APHIS received one 
comment on the subject EA during the designated 30-day public comment 
period, which ended March 27, 2002. The comment, which was from a 
consumer organization, cited alleged deficiencies in the EA prepared 
for the antecedent organism and the EA for events MS1 and RF1 and RF2. 
APHIS has provided a response to this comment as an attachment to the 
finding of no significant impact (FONSI). The EA and FONSI are 
available from the person listed under FOR FURTHER INFORMATION CONTACT.

Analysis

    Like the antecedent organisms, canola events MS1 and RF1 and RF2 
have been genetically engineered to contain a barnase gene (MS1) for 
male sterility or a barstar gene (RF1 and RF2) for fertility 
restoration. The barnase gene expresses a ribonuclease that blocks 
pollen development and results in a male-sterile plant, and the barstar 
gene encodes a specific inhibitor of this ribonuclease and restores 
fertility. The barnase and barstar genes were derived from Bacillus 
amyloliquefaciens, and are linked in the subject canola events to the 
bar gene derived from Streptomyces hygroscopicus. The bar gene encodes 
the enzyme phosphinothricin-N-acetyltransferase (PAT), which confers 
tolerance to the herbicide glufosinate. The subject canola events and 
the antecedent organisms were developed through use of the 
Agrobacterium tumefaciens method, and expression of the added genes in 
MS1 and RF1 and RF2 and the antecedent organisms is controlled in part 
by gene sequences derived from the plant pathogen A. tumefaciens. In 
summary, the Aventis extension request states that canola events MS1 
and RF1 and RF2 and the antecedent organisms contain the same genetic 
elements with the exception of the antibiotic resistance marker gene 
nptII in MS1 and RF1 and RF2, which was used as a transformant 
selection tool during the developmental process. The parental variety 
Drakkar was used to develop both the antecedent organisms and MS1 and 
RF1 and RF2.
    Canola events MS1 and RF1 and RF2 and the antecedent organisms were 
genetically engineered using the same transformation method and contain 
the same enzymes for male sterility, fertility restoration, and 
glufosinate herbicide tolerance. Accordingly, we have determined that 
canola events MS1 and RF1 and RF2 are similar to the antecedent 
organisms in APHIS petition number 98-278-01p, and that canola events 
MS1 and RF1 and RF2 should no longer be regulated under the regulations 
in 7 CFR part 340.
    The subject canola events have been considered regulated articles 
under APHIS' regulations in 7 CFR part 340 because they contain gene 
sequences derived from a plant pathogen. However, canola events MS1 and 
RF1 and RF2 have been field tested in numerous countries, including the 
United States and Canada, and after having received the appropriate 
Canadian approvals, have been marketed commercially in Canada since 
1996 with no reports of adverse effects on human health or the 
environment.

Determination

    Based on an analysis of the data submitted by Aventis and a review 
of other scientific data, APHIS has determined that canola events MS1 
and RF1 and RF2: (1) Exhibit no plant pathogenic properties; (2) are no 
more likely to become a weed than canola varieties developed by 
traditional breeding techniques and are unlikely to increase the 
weediness potential for any other cultivated or wild species with which 
they can interbreed; (3) will not cause damage to raw or processed 
agricultural commodities; (4) will not harm threatened or endangered 
species or other organisms, such as bees, that are beneficial to 
agriculture; and (5) are unlikely to have any significant adverse 
impact on agricultural practices. Therefore, APHIS has concluded that 
canola events MS1 and RF1 and RF2 and any progeny derived from crosses 
with other canola varieties will be as safe to grow as canola that is 
not subject to regulation under 7 CFR part 340.
    Because APHIS has determined that the subject canola events do not 
present a plant pest risk based on their similarity to the antecedent 
organisms, Aventis' canola events MS1 and RF1 and RF2 will be no longer 
be considered regulated articles 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 canola events or their progeny. 
However, importation of canola events MS1 and RF1 and RF2 and 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 EA was prepared to examine any potential environmental impacts 
associated with the proposed extension of a determination of 
nonregulated status for the subject canola events. 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 
FONSI with regard to the determination that Aventis canola events MS1 
and RF1 and RF2 and events developed from them are no longer regulated 
articles under its regulations in 7 CFR part 340. Copies of the EA and 
FONSI are available from the individual listed under FOR FURTHER 
INFORMATION CONTACT.

    Done in Washington, DC, this 19th day of November 2002.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 02-29754 Filed 11-21-02; 8:45 am]
BILLING CODE 3410-34-P