[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 3410-34-P