[Federal Register Volume 70, Number 51 (Thursday, March 17, 2005)]
[Notices]
[Pages 13007-13008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5302]


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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 
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  Federal Register / Vol. 70, No. 51 / Thursday, March 17, 2005 / 
Notices  

[[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: [email protected]. 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