[Federal Register: March 17, 2005 (Volume 70, Number 51)]
[Notices]
[Page 13007-13008]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr05-19]
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Notices
Federal Register
________________________________________________________________________
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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[[Page 13007]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 04-075-2]
Monsanto Co. and KWS SAAT AG; Determination of Nonregulated
Status for Sugar Beet Genetically Engineered for Tolerance to the
Herbicide Glyphosate
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that the
Monsanto and KWS SAAT AG sugar beet designated as event H7-1, which has
been genetically engineered for tolerance to the herbicide glyphosate,
is no longer considered a regulated article under our regulations
governing the introduction of certain genetically engineered organisms.
Our determination is based on our evaluation of data submitted by
Monsanto Company and KWS SAAT AG in its petition for a determination of
nonregulated status, our analysis of other scientific data, and
comments received from the public in response to a previous notice.
This notice also announces the availability of our written
determination and our finding of no significant impact.
EFFECTIVE DATE: March 4, 2005.
ADDRESSES: You may read a copy of the determination, the environmental
assessment and finding of no significant impact, the petition for a
determination of nonregulated status submitted by Monsanto Company and
KWS SAAT AG, and all comments received on the petition and the
environmental assessment 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.
You may view APHIS documents published in the Federal Register and
related information on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html
.
FOR FURTHER INFORMATION CONTACT: Mr. John Cordts, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 734-5531. To obtain copies of the petition, the
environmental assessment (EA), finding of no significant impact
(FONSI), or the determination, contact Ms. Ingrid Berlanger at (301)
734-4885; e-mail: Ingrid.E.Berlanger@aphis.usda.gov. The petition, EA,
FONSI, and determination are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/03_32301p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/03_32301p_ea.pdf.
SUPPLEMENTARY INFORMATION:
Background
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 a determination of nonregulated status
must take and the information that must be included in the petition.
On November 19, 2003, APHIS received a petition (APHIS Petition
Number 03-323-01p) from Monsanto Company of St. Louis, MO, and KWS SAAT
AG of Einbeck, Germany (Monsanto/KWS), requesting a determination of
nonregulated status under 7 CFR part 340 for sugar beet (Beta vulgaris
ssp. vulgaris) designated as event H7-1, which has been genetically
engineered for tolerance to the herbicide glyphosate. The Monsanto/KWS
petition states that the subject sugar beet should not be regulated by
APHIS because it does not present a plant pest risk.
On October 19, 2004, APHIS published a notice in the Federal
Register (69 FR 61466-61467, Docket No. 04-075-1) announcing that the
Monsanto/KWS petition and an environmental assessment (EA) were
available for public review. That notice also discussed the role of
APHIS, the Environmental Protection Agency, and the Food and Drug
Administration in regulating the subject sugar beet and food products
developed from it. APHIS received 44 comments on the petition and the
EA during the 60-day comment period, which ended December 20, 2004.
The comments were received from growers and grower associations,
sugar processing cooperatives, academic researchers, seed companies,
two biodynamic farmers, and one consumer organization. Forty-one of the
comments supported approval of the petition in full. Three comments
opposed the petition. One, a sugar processor, opposed the petition
based on potential economic concerns; the biodynamic farmers generally
opposed biotechnology, and the consumer group also opposed
biotechnology and suggested that the EA is inadequate and an
environmental impact statement should be prepared. APHIS disagrees with
the suggestion of the consumer group and has provided a response to all
of the comments as an attachment to the finding of no significant
impact (FONSI). The EA and FONSI are available as indicated under FOR
FURTHER INFORMATION CONTACT.
Sugar beet event H7-1 has been genetically engineered to express a
5-enolpyruvyshikimate-3-phosphate synthase protein from Agrobacterium
sp. strain CP4 (CP4 EPSPS), which confers tolerance to the herbicide
glyphosate. Expression of the added genes is controlled in part by the
35S promoter derived from the plant pathogen figwort mosaic virus. The
Agrobacterium tumefaciens
[[Page 13008]]
transformation method was used to transfer the added genes into the KWS
proprietary sugar beet line 3S0057.
Sugar beet event H7-1 has been considered a regulated article under
the regulations in 7 CFR part 340 because it contains gene sequences
from plant pathogens. In the process of reviewing the notifications for
field trials of the subject sugar beet, APHIS determined that the
vectors and other elements were disarmed and that the trials, which
were conducted under conditions of reproductive and physical
confinement or isolation, would not present a risk of plant pest
introduction or dissemination.
Determination
Based on its analysis of the data submitted by Monsanto/KWS, a
review of other scientific data, field tests of the subject sugar beet,
and comments submitted by the public, APHIS has determined that H7-1
sugar beet : (1) Exhibits no plant pathogenic properties; (2) is no
more likely to become weedy than the nontransgenic parental line or
other cultivated sugar beet; (3) is unlikely to increase the weediness
potential of any other cultivated or wild species with which it can
interbreed; (4) will not cause damage to raw or processed agricultural
commodities; (5) will not harm threatened or endangered species or
organisms that are beneficial to agriculture; and (6) should not reduce
the ability to control pests and weeds in sugar beet or other crops.
Therefore, APHIS has concluded that the subject sugar beet and any
progeny derived from hybrid crosses with other non-transformed sugar
beet varieties will be as safe to grow as sugar beets in traditional
breeding programs that are not subject to regulation under 7 CFR part
340. The effect of this determination is that Monsanto/KWS' H7-1 sugar
beet is no longer 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 subject sugar beet or its
progeny. However, importation of H7-1 sugar beet and seeds capable of
propagation are still subject to the restrictions found in APHIS'
foreign quarantine notices in 7 CFR part 319 and imported seed
regulations in 7 CFR part 361.
National Environmental Policy Act
An EA was prepared to examine any potential environmental impacts
associated with the proposed determination of nonregulated status for
the subject sugar beet event. 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 Monsanto/KWS H7-1 sugar beet and lines developed
from it 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 11th day of March 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-5302 Filed 3-16-05; 8:45 am]
BILLING CODE 3410-34-P