[Federal Register Volume 63, Number 235 (Tuesday, December 8, 1998)]
[Notices]
[Pages 67643-67644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32519]
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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. 63, No. 235 / Tuesday, December 8, 1998 /
Notices
[[Page 67643]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 98-114-1]
AgrEvo USA Co.; Receipt of Petition for 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 that the Animal and Plant Health
Inspection Service has received a petition from AgrEvo USA Company
seeking a determination of nonregulated status for certain canola
transformation events, which have been genetically engineered for male
sterility, fertility restoration, and tolerance to the herbicide
glufosinate. The petition has been submitted in accordance with our
regulations concerning the introduction of certain genetically
engineered organisms and products. In accordance with those
regulations, we are soliciting public comments on whether these canola
transformation events present a plant pest risk.
DATES: Written comments must be received on or before February 8, 1999.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 98-114-1, Regulatory Analysis and Development, PPD, APHIS,
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please
state that your comments refer to Docket No. 98-114-1. A copy of the
petition and any comments received may be inspected at USDA, room 1141,
South Building, 14thStreet and Independence Avenue SW., Washington, DC,
between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays.
Persons wishing access to that room to inspect the petition or comments
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
petition, 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. Paragraphs (b) and (c) of Sec. 340.6 describe the form
that a petition for determination of nonregulated status must take and
the information that must be included in the petition.
On October 5, 1998, APHIS received a petition (APHIS Petition No.
98-278-01p) from AgrEvo USA Company (AgrEvo) of Wilmington, DE,
requesting a determination of nonregulated status under 7 CFR part 340
for canola (Brassica napus L.) designated as In Vigor Hybrid
Canola Transformation Events (transformation events) MS8 and RF3, and
their hybrid combination MS8/RF3. The subject transformation events
have been genetically engineered for male sterility (MS8), fertility
restoration (RF3), and tolerance to the herbicide glufosinate (both MS8
and RF3), to enable the production of pure hybrid canola varieties by
the use of a pollination control system. AgrEvo's petition states that
the subject canola transformation events should not be regulated by
APHIS because they do not present a plant pest risk.
As described in the petition, these canola transformation events
have been genetically engineered to contain a barnase gene (MS8) for
male sterility or the barstar gene (RF3) for fertility restoration. The
barnase gene expresses a ribonuclease that blocks pollen development
and results in a male sterile plant, while 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 the regulations
in 7 CFR part 340 because they contain gene sequences from a plant
pathogen. These canola transformation events have been field tested in
Canada since 1994, in Europe since 1995, and in the U. S. since 1997
under APHIS permits and notifications. In the process of reviewing the
permit applications and notifications for field trials of these canola
transformation events, APHIS determined that the vectors and other
elements were disarmed and that the trials, which were conducted under
conditions of reproductive and physical containment or isolation, would
not present a risk of plant pest introduction or dissemination. Canola
transformation events MS8, RF3, and their hybrid combination MS8/RF3
were approved in 1996 by Agriculture and Agri-Food Canada for
unconfined environmental release and use as livestock feed in Canada,
and in 1997, Health Canada
[[Page 67644]]
approved oil from the subject transformation events for sale as human
food in Canada.
In the Federal Plant Pest Act, as amended (7 U.S.C. 150aa et seq.),
plant pest is defined as ``any living stage of: Any insects, mites,
nematodes, slugs, snails, protozoa, or other invertebrate animals,
bacteria, fungi, other parasitic plants or reproductive parts thereof,
viruses, or any organisms similar to or allied with any of the
foregoing, or any infectious substances, which can directly or
indirectly injure or cause disease or damage in any plants or parts
thereof, or any processed, manufactured or other products of plants.''
APHIS views this definition very broadly. The definition covers direct
or indirect injury, disease, or damage not just to agricultural crops,
but also to plants in general, for example, native species, as well as
to organisms that may be beneficial to plants, for example, honeybees,
rhizobia, etc.
The U. S. Environmental Protection Agency (EPA) is responsible for
the regulation of pesticides under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq.). FIFRA
requires that all pesticides, including herbicides, be registered prior
to distribution or sale, unless exempt by EPA regulation. In cases in
which genetically modified plants allow for a new use of an herbicide
or involve a different use pattern for the herbicide, EPA must approve
the new or different use. When the use of the herbicide on the
genetically modified plant would result in an increase in the residues
of the herbicide in a food or feed crop for which the herbicide is
currently registered, or in new residues in a crop for which the
herbicide is not currently registered, establishment of a new tolerance
or a revision of the existing tolerance would be required. Residue
tolerances for pesticides are established by EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 et
seq.), and the Food and Drug Administration (FDA) enforces tolerances
set by EPA under the FFDCA. Accordingly, AgrEvo has submitted to EPA
both registration and tolerance exemption applications for glufosinate
use on canola.
FDA published a statement of policy on foods derived from new plant
varieties in the Federal Register on May 29, 1992 (57 FR 22984-23005).
The FDA statement of policy includes a discussion of FDA's authority
for ensuring food safety under the FFDCA, and provides guidance to
industry on the scientific considerations associated with the
development of foods derived from new plant varieties, including those
plants developed through the techniques of genetic engineering. AgrEvo
has completed consultation with FDA on the subject canola
transformation events.
In accordance with Sec. 340.6(d) of the regulations, we are
publishing this notice to inform the public that APHIS will accept
written comments regarding the Petition for Determination of
Nonregulated Status from any interested person for a period of 60 days
from the date of this notice. The petition and any comments received
are available for public review, and copies of the petition may be
ordered (see the ADDRESSES section of this notice).
After the comment period closes, APHIS will review the data
submitted by the petitioner, all written comments received during the
comment period, and any other relevant information. Based on the
available information, APHIS will furnish a response to the petitioner,
either approving the petition in whole or in part, or denying the
petition. APHIS will then publish a notice in the Federal Register
announcing the regulatory status of AgrEvo's canola transformation
events MS8, RF3, and their hybrid combination MS8/RF3, and the
availability of APHIS' written decision.
Authority: 7 U.S.C. 150aa-150jj, 151-167, and 1622n; 31 U.S.C.
9701; 7 CFR 2.22, 2.80, and 371.2(c).
Done in Washington, DC, this 2nd day of December 1998.
Joan M. Arnoldi,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-32519 Filed 12-7-98; 8:45 am]
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