[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)]
[Notices]
[Pages 59181-59182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-2471]



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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 04-076-1]


Monsanto Co.; Availability of Petition and Environmental 
Assessment for Determination of Nonregulated Status for Cotton 
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 that the Animal and Plant Health 
Inspection Service has received a petition from Monsanto Company 
seeking a determination of nonregulated status for cotton designated as 
MON 88913, 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 public comments on whether this cotton 
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 December 
3, 2004.

ADDRESSES: You may submit comments by any of the following methods:
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. 04-076-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your 
comment refers to Docket No. 04-076-1.
     E-mail: Address your comment to 
[email protected]. Your comment must be contained in the body 
of your message; do not send attached files.
     Agency Web Site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html for a form you can use to submit an e-mail comment through 
the APHIS Web site.
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for locating this 
docket and submitting comments.
    Reading Room: You may read the petition, the environmental 
assessment, and 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: You may view APHIS documents published in the 
Federal Register and related information, including the names of groups 
and individuals who have commented on APHIS dockets, on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Mr. Michael Blanchette, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-5141. To obtain copies of the petition or the 
environmental assessment, contact Ms. Terry Hampton at (301) 734-5715; 
e-mail: [email protected]. The petition and environmental 
assessment are also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/04_08601p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/04_08601p_ea.pdf.

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 a determination of nonregulated status 
must take and the information that must be included in the petition.
    On March 26, 2004, APHIS received a petition from Monsanto Company 
of St. Louis, MO, (Monsanto), requesting a determination of 
nonregulated status under 7 CFR part 340 for cotton (Gossypium hirsutum 
L.) designated as MON 88913, which has been genetically engineered for 
tolerance to the herbicide glyphosate. The Monsanto petition states 
that the subject cotton should not be regulated by APHIS because it 
does not present a plant pest risk.
    As described in the petition, MON 88913 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 gene sequences derived from the plant pathogens 
figwort mosaic virus and cauliflower mosaic virus. The Agrobacterium 
tumefaciens transformation method was used to transfer the added genes 
into the recipient upland cotton variety Coker 312.
    MON 88913 cotton 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 cotton, 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.
    In Sec.  403 of the Plant Protection Act (7 U.S.C. 7701-7772), 
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 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 a pesticide or 
involve a different use pattern for the pesticide, EPA must approve the 
new or different use. Accordingly, Monsanto has submitted glyphosate 
residue data and proposed labeling to EPA for the

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expanded use of Roundup UltraMAX([reg]) herbicide on MON 88913.
    When the use of the pesticide on the genetically modified plant 
would result in an increase in the residues in a food or feed crop for 
which the pesticide is currently registered, or in new residues in a 
crop for which the pesticide 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. EPA has previously 
established an exemption from the requirement for a tolerance for the 
CP4 EPSPS protein in or on all raw agricultural commodities.
    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. 
Monsanto has begun consultation with FDA on the food and feed safety 
and nutritional assessment of the subject cotton.
    To provide the public with documentation of APHIS' review and 
analysis of the environmental impacts and plant pest risk associated 
with a proposed determination of nonregulated status for Monsanto's 
88913 cotton, an environmental assessment (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 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 persons for a period of 60 days 
from the date of this notice. We are also soliciting written comments 
from interested persons on the EA prepared to examine any environmental 
impacts of the proposed determination for the subject cotton. The 
petition and the EA and any comments received are available for public 
review, and copies of the petition 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 MON 88913 cotton 
and the availability of APHIS' written decision.

    Authority: 7 U.S.C. 1622n and 7701-7772; 31 U.S.C. 9701; 7 CFR 
2.22, 2.80, and 371.3.

    Done in Washington, DC, this 28th day of September 2004.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E4-2471 Filed 10-1-04; 8:45 am]
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