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Monsanto Company; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Soybean Genetically Engineered for Glyphosate Herbicide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: February 5, 2007 (Volume 72, Number 23)]
[Notices]
[Page 5261-5263]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05fe07-25]

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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.

[[Page 5262]]

    ? 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, virgil.d.meier@aphis.usda.gov. To obtain
copies of the petition or environmental assessment (EA), contact Ms.
Cynthia Eck at (301) 734-0667; cynthia.a.eck@aphis.usda.gov. 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

[[Page 5263]]

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]
BILLING CODE 3410-34-P

 
 

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