[Federal Register Volume 64, Number 61 (Wednesday, March 31, 1999)]
[Notices]
[Pages 15337-15338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7803]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 98-114-2]


AgrEvo USA Co.; Availability 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 determination that certain 
canola transformation events developed by AgrEvo USA Company, 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 
determination is based on our evaluation of data submitted by AgrEvo 
USA Company in its petition for a determination of nonregulated status 
and on our analysis of other scientific data. This notice also 
announces the availability of our written determination document and 
its associated environmental assessment and finding of no significant 
impact.

EFFECTIVE DATE: March 22, 1999.

ADDRESSES: The determination, an environmental assessment and finding 
of no significant impact, and the petition 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. Susan Koehler, Biotechnology and 
Biological Analysis, PPQ, APHIS, Suite 5B05, 4700 River Road Unit 147, 
Riverdale, MD 20737-1236; (301) 734-4886. To obtain a copy of the 
determination or the environmental assessment and finding of no 
significant impact, contact Ms. Kay Peterson at

[[Page 15338]]

(301) 734-4885; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    On October 5, 1998, the Animal and Plant Health Inspection Service 
(APHIS) received a petition (APHIS Petition No. 98-278-01p) from AgrEvo 
USA Company (AgrEvo) of Wilmington, DE, seeking a determination that 
canola (Brassica napus L.) designated as In Vigor Hybrid 
Canola Transformation Events MS8 and RF3 (transformation events), which 
have been genetically engineered for male sterility (MS8), fertility 
restoration (RF3), and tolerance to the herbicide glufosinate (both MS8 
and RF3), do not present a plant pest risk and, therefore, are not 
regulated articles under APHIS' regulations in 7 CFR part 340.
    On December 8, 1998, APHIS published a notice in the Federal 
Register (63 FR 67643-67644, Docket No. 98-114-1) announcing that the 
AgrEvo petition had been received and was available for public review. 
The notice also discussed the role of APHIS, the Environmental 
Protection Agency, and the Food and Drug Administration in regulating 
the subject canola transformation events and food products derived from 
them. In the notice, APHIS solicited written comments from the public 
as to whether these canola transformation events posed a plant pest 
risk. The comments were to have been received by APHIS on or before 
February 8, 1999. APHIS received no comments on the subject petition 
during the designated 60-day comment period.
Analysis
    The subject transformation events have been genetically engineered 
to contain a barnase gene (MS8) for male sterility or a barstar gene 
(RF3) 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 transformation 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 herbicide tolerance trait allows for selection of 
plants carrying the linked genes for pollination control during 
breeding and for tolerance to the herbicide during commercial 
cultivation. Expression of the added genes is controlled in part by 
gene sequences derived from Arabidopsis thaliana, Nicotiana tabacum, 
and the plant pathogen Agrobacterium tumefaciens. The A. tumefaciens 
method was used to transfer the added genes into the parental canola 
variety, Drakkar.
    Canola transformation events MS8, RF3, and their hybrid combination 
MS8/RF3 have been considered regulated articles under APHIS' 
regulations in 7 CFR part 340 because they contain gene sequences 
derived from a plant pathogen. However, evaluation of field data 
reports from field tests of these canola transformation events 
conducted under APHIS permits and notifications since 1997 indicates 
that there were no deleterious effects on plants, nontarget organisms, 
or the environment as a result of the environmental release of the 
subject canola transformation events.

Determination

    Based on its analysis of the data submitted by AgrEvo and a review 
of other scientific data and field tests of the subject canola, APHIS 
has determined that canola transformation events MS8, RF3, and their 
hybrid combination MS8/RF3: (1) Exhibit no plant pathogenic properties; 
(2) are no more likely to become weeds than canola 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 
the subject canola transformation events and any progeny derived from 
hybrid crosses with other canola varieties will be as safe to grow as 
canola in breeding programs that are not subject to regulation under 7 
CFR part 340.
    The effect of this determination is that AgrEvo's canola 
transformation events MS8, RF3, and their hybrid combination MS8/RF3 
are no longer 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 subject canola 
transformation events or their progeny. However, importation of these 
canola transformation events 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 canola transformation events MS8, RF3, and 
their hybrid combination MS8/RF3 and lines developed from them 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 24th day of March 1999.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-7803 Filed 3-30-99; 8:45 am]
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