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Monsanto Co.; Availability of Determination of Nonregulated Status for Cotton Genetically Engineered for Tolerance to the Herbicide Glyphosate

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Animal and Plant Health Inspection Service, USDA.




We are advising the public of our determination that the Monsanto Company cotton designated as MON 88913, 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 in its petition for a determination of non-regulated 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: December 20, 2004.


You may read the determination, the environmental assessment and finding of no significant impact, the petition for a determination of nonregulated status submitted by Monsanto Company, 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, including the names of groups and individuals who have commented on APHIS dockets, on the Internet at​ppd/​rad/​webrepor.html.

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Mr. Michael Blanchette, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-5141. To obtain a copy of the determination or environmental assessment and finding of no significant impact, contact Ms. Terry Hampton at (301) 734-5715; e-mail: The petition and environmental assessment are also available on the Internet at​brs/​aphisdocs/​04_​08601p.pdf and​brs/​aphisdocs/​04_​08601p_​ea.pdf. The determination and the final environmental assessment and finding of no significant impact are available on the Internet at​brs/​aphisdocs/​04_​08601p_​com.pdf.

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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 § 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 § 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.

On October 4, 2004, APHIS published a notice in the Federal Register (69 FR 59181-59182, Docket No. 04-076-1) announcing that the Monsanto petition and an environmental assessment (EA) were available for public review. The notice also discussed the role of APHIS, the Environmental Protection Agency, and the Food and Drug Administration in regulating the subject cotton and food products developed from it. In a subsequent notice published in the Federal Register on November 24, 2004 (69 FR 68301-68302, Docket No. 04-076-2), APHIS announced the availability of an addendum to the Monsanto petition.

APHIS received three comments on the petition and the EA during the 60-day comment period, which ended December 4, 2004. The comments were from a university professor, a trade organization, and a private individual. Two of the commenters supported nonregulated status for MON 8891, while the third commenter opposed it. APHIS has provided a response to these 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.

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 Start Printed Page 71regulations 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.


Based on its analysis of the data submitted by Monsanto Company, a review of other scientific data, field tests of the subject cotton, and comments submitted by the public, APHIS has determined that MON 88913 cotton: (1) Exhibits no plant pathogenic properties; (2) is no more likely to become weedy than the non-transgenic parental line or other cultivated cotton; (3) is unlikely to increase the weediness potential for 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 cotton or other crops. Therefore, APHIS has concluded that the subject cotton and any progeny derived from hybrid crosses with other non-transformed cotton varieties will be as safe to grow as cotton in traditional breeding programs that is not subject to regulation under 7 CFR part 340.

The effect of this determination is that Monsanto Company's MON 88913 cotton 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 cotton or its progeny. However, importation of MON 88913 cotton 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 non-regulated status for the subject cotton 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 MON 88913 cotton 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 as indicated in the FOR FURTHER INFORMATION CONTACT section of this notice.

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Done in Washington, DC, this 27th day of December 2004.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

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[FR Doc. E4-3908 Filed 12-30-04; 8:45 am]