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Bayer CropScience; Determination of Nonregulated Status for Cotton Genetically Engineered for Glyphosate Herbicide Tolerance

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Animal and Plant Health Inspection Service, USDA.




We are advising the public of our determination that a cotton line developed by Bayer CropScience, designated as transformation event GHB614, 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 the Bayer CropScience 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 announcing the availability of the petition for nonregulated status, our environmental assessment, and the pest risk assessment. This notice also announces the availability of our determination and finding of no significant impact.


Effective Date: May 22, 2009.


You may read the petition, the final environmental assessment, the pest risk assessment, the determination, the finding of no significant impact, comments we received on our previous notice, and our responses to those comments 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. To view these documents on the Internet, go to​fdmspublic/​component/​main?​main=​DocketDetail&​d=​APHIS-2007-0017.

Other Information: Additional information about APHIS and its programs is available on the Internet at

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Dr. Patricia Beetham, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-0664, e-mail: To obtain copies of the petition, final environmental assessment, or the finding of no significant impact, contact Ms. Cindy Eck by telephone at (301) 734-0667 or via e-mail: The petition, final environmental assessment and finding of no significant impact are also available on the Internet at​brs/​aphisdocs/​06_​33201p.pdf and​brs/​aphisdocs/​06_​33201p_​ea.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 Start Printed Page 23988must take and the information that must be included in the petition.

On November 28, 2006, APHIS received a petition seeking a determination of nonregulated status (APHIS No. 06-332-01p) from Bayer CropScience (BCS) of Research Triangle Park, NC, for cotton (Gossypium hirsutum) designated as transformation event GHB614, which has been genetically engineered for tolerance to the herbicide glyphosate, stating that cotton line GHB614 does not present a plant pest risk. BCS responded to APHIS' subsequent request for additional information and clarification on May 11, 2007.


As described in the petition, cotton transformation event GHB614 utilizes the enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) gene isolated from a previously deregulated cotton event (Event GA21; APHIS petition number 97-099-01) and introduces two amino acid substitutions within the EPSPS gene (designated 2mEPSPS). These modifications decrease the binding affinity to glyphosate, thus producing tolerance to the herbicide. The 2mEPSPS protein allows the plant to tolerate applications of the broad spectrum herbicide glyphosate. Regulatory elements for the transgenes were obtained from Agrobacterium tumefaciens and were introduced into cotton cells using Agrobacterium-mediated transformation methodology. These regulatory sequences are not transcribed and do not encode proteins.

Transformation event GHB614 has been considered a regulated article under the regulations in 7 CFR part 340 because it contains gene sequences from a plant pathogen. GHB614 cotton has been field tested in the United States since 2002 under notifications authorized by the APHIS. In the process of reviewing the permits for field trials of the subject cotton 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 presented two alternatives in the draft environmental assessment (EA) based on its analyses of data submitted by BCS, a review of other scientific data, as well as data gathered from field tests conducted under APHIS oversight.

In a notice [1] published in the Federal Register on June 18, 2008 (73 FR 34968-34700, Docket No. APHIS-2007-0017), APHIS announced the availability of BCS' petition and a draft EA for public comment. APHIS solicited comments on whether the subject cotton event would present a plant pest risk and on the EA. APHIS received nine comments by the close of the 60-day comment period, which ended on August 18, 2008. There were six comments that supported deregulation, two from cotton industry groups and four from individuals. There were three comments that opposed deregulation, one comment from a non-government organization and two comments from individuals. APHIS has addressed the issues raised during the comment period and has provided responses to these comments as an attachment to the finding of no significant impact.


Based on APHIS' analysis of field, greenhouse and laboratory data submitted by BCS, references provided in the petition, information described in the final EA and in the finding of no significant impact, and a careful evaluation of the comments provided by the public, APHIS has determined that GHB614 cotton will not pose a plant pest risk for the following reasons: (1) Gene introgression from GlyTolTM cotton (event GHB614) into wild relatives in the United States and its territories is extremely unlikely and is not likely to increase the weediness potential of any resulting progeny or adversely affect genetic diversity of related plants any more than would introgression from traditional cotton varieties; (2) it exhibits no characteristics that would cause it to be weedier than the non-genetically engineered parent cotton line or any other cultivated cotton; (3) it does not pose a risk to non-target organisms, including organisms beneficial to agriculture and Federally listed threatened or endangered species, and species proposed for listing; (4) it does not pose a threat to biodiversity as it does not exhibit traits that increase its weediness, and its unconfined cultivation should not lead to increased weediness of other cultivated cotton, it exhibits no changes in disease susceptibility, and it is unlikely to harm non-target organisms common to the agricultural ecosystem or Federally listed or proposed threatened or endangered species; (5) compared to current cotton pest and weed management practices, cultivation of GlyTolTM cotton should not impact standard agricultural practices in cotton cultivation including those for organic farmers; and (6) disease susceptibility and compositional profiles of GlyTolTM cotton are similar to those of its parent line and other cotton cultivars grown in the United States; therefore no direct or indirect plant pest effects on raw or processed plant commodities are expected.

National Environmental Policy Act

To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with the determination of nonregulated status for GHB614 cotton, an EA was 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). Based on the final EA, the pest risk assessment, other pertinent scientific data, and our evaluation of the comments provided by the public, APHIS has reached a finding of no significant impact (FONSI) with regard to the determination that BCS' GHB614 cotton line and lines developed from it are no longer regulated articles under its regulations in 7 CFR part 340. Copies of the final EA and FONSI are available as indicated in the ADDRESSES and FOR FURTHER INFORMATION CONTACT sections of this notice.

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Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.

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Done in Washington, DC, this 18th day of May 2009.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

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[FR Doc. E9-11972 Filed 5-21-09; 8:45 am]