[Federal Register Volume 72, Number 23 (Monday, February 5, 2007)]
[Notices]
[Pages 5261-5263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1793]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2006-0195]


Monsanto Company; Availability of Petition and Environmental 
Assessment for Determination of Nonregulated Status for Soybean 
Genetically Engineered for Glyphosate 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 Monsanto Company 
seeking a determination of nonregulated status for soybean designated 
as MON 89788, which has been genetically engineered for tolerance to 
the herbicide glyphosate. 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 comments on whether this soybean 
presents a plant pest risk. We are also making available for public 
comment an environmental assessment for the proposed determination of 
nonregulated status.

DATES: We will consider all comments we receive on or before April 6, 
2007.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov, select ``Animal and Plant Health Inspection 
Service'' from the agency drop-down menu, then click ``Submit.'' In the 
Docket ID column, select APHIS-2006-0195 to submit or view public 
comments and to view supporting and related materials available 
electronically. Information on using Regulations.gov, including 
instructions for accessing documents, submitting comments, and viewing 
the docket after the close of the comment period, is available through 
the site's ``User Tips'' link.

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     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2006-0195, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. APHIS-2006-0195.
    Reading Room: You may read any comments that we receive on this 
docket 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.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Virgil Meier, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-3363, [email protected]. To obtain 
copies of the petition or environmental assessment (EA), contact Ms. 
Cynthia Eck at (301) 734-0667; [email protected]. The 
petition and EA may be viewed on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/06_17801p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/06_17801p_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 June 27, 2006, APHIS received a petition seeking a determination 
of nonregulated status (APHIS Petition Number 06-178-01p) from Monsanto 
Company of St. Louis, MO (Monsanto), for soybean (Glycine max L.) 
designated as transformation event MON 89788, which has been 
genetically engineered for tolerance to the herbicide glyphosate, 
stating that soybean line MON 89788 does not present a plant pest risk 
and, therefore, should not be a regulated article under APHIS' 
regulations in 7 CFR part 340.
    As described in the petition, MON 89788 soybean plants have been 
genetically engineered to express a 5-enolpyruvylshikimate-3-phosphate 
synthase protein from Agrobacterium sp. strain CP4 (CP4 EPSPS), which 
confers tolerance to the herbicide glyphosate. Expression of the added 
gene is controlled, in part, by gene sequences derived from Arabidopsis 
thaliana and the plant pathogen figwort mosaic virus. The Agrobacterium 
tumefaciens transformation method was used to transfer the added 
genetic material into the recipient parental soybean line A3244.
    MON 89788 soybean plants have been considered regulated articles 
under the regulations in 7 CFR part 340 because they contain gene 
sequences from plant pathogens. MON 89788 soybean plants have been 
field tested in the United States since 2001 under notifications 
authorized by APHIS. In the process of reviewing the notifications for 
field trials of the subject soybean plants, APHIS determined that the 
vectors and other elements were disarmed and that trials, which were 
conducted under conditions of reproductive and physical confinement or 
isolation, would not present a risk of plant pest introduction or 
dissemination.
    APHIS has prepared an environmental assessment (EA) in which it 
presents three alternatives based on its analyses of data submitted by 
Monsanto, a review of other scientific data, and field tests conducted 
under APHIS oversight. APHIS may: (1) Take no action, (2) deregulate 
MON 89788 soybeans, or (3) deregulate MON 89788 soybeans in part.
    In section 403 of the Plant Protection Act (7 U.S.C. 7701 et seq.), 
``plant pest'' is defined as any living stage of any of the following 
that can directly or indirectly injure, cause damage to, or cause 
disease in any plant or plant product: A protozoan, a nonhuman animal, 
a parasitic plant, a bacterium, a fungus, a virus or viroid, an 
infectious agent or other pathogen, or any article similar to or allied 
with any of the foregoing. APHIS views this definition broadly to cover 
direct or indirect injury, disease, or damage not just to agricultural 
crops, but also to other plants, for example, native species, as well 
as organisms that may be beneficial to plants, such as honeybees.
    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 from EPA regulation. Under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 
et seq.), pesticides added to (or contained in) raw agricultural 
commodities generally are considered to be unsafe unless a tolerance or 
exemption from tolerance has been established. Residue tolerances for 
pesticides are established by the EPA under the FFDCA, and the Food and 
Drug Administration (FDA) enforces tolerances set by the EPA. Because 
of the similarity in tolerance to glyphosate for MON 89788 and the 
previously deregulated event MON-04032-6, Monsanto has not requested a 
label change for the application of glyphosate to MON 89788 soybeans.
    The FDA's policy statement concerning regulation of products 
derived from new plant varieties, including those genetically 
engineered, was published in the Federal Register on May 29, 1992 (57 
FR 22984-23005). Under this policy, FDA uses what is termed a 
consultation process to ensure that human and animal feed safety issues 
or other regulatory issues (e.g., labeling) are resolved prior to 
commercial distribution of a bioengineered food. Monsanto submitted a 
food and feed safety and nutritional assessment summary to the FDA for 
the MON 89788 soybean. A final FDA decision is pending.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
proposed determination of nonregulated status for MON 89788, an EA has 
been prepared. 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

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implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing 
Procedures (7 CFR part 372).
    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 a determination of 
nonregulated status from interested or affected persons for a period of 
60 days from the date of this notice. We are also soliciting written 
comments from interested or affected persons on the EA prepared to 
examine any environmental impacts of the proposed determination for the 
subject soybean event. The petition and the EA and any comments we 
receive are available for public review, and copies of the petitions 
and the EA are available as indicated in the FOR FURTHER INFORMATION 
CONTACT 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. After reviewing and 
evaluating the comments on the petition and the EA and other data and 
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 Monsanto's glyphosate-tolerant soybean and the 
availability of APHIS' written decision.

Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 
2.22, 2.8, and 371.3.

    Done in Washington, DC, this 30th day of January 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-1793 Filed 2-2-07; 8:45 am]
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