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Bayer CropScience; Availability of Petition and Draft Environmental Assessment for Determination of Nonregulated Status for Cotton Genetically Engineered for Glyphosate Herbicide Tolerance

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Animal and Plant Health Inspection Service, USDA.



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We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Bayer CropScience seeking a determination of nonregulated status for cotton genetically engineered for tolerance to the herbicide glyphosate derived from a transformation event designated as GHB614. 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 genetically engineered cotton is or could be a plant pest. We are making available for public comment the petition and draft environmental assessment for the proposed determination of nonregulated status.


We will consider all comments that we receive on or before August 18, 2008.


You may submit comments by either of the following methods:

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

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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 or the draft environmental assessment, contact Ms. Cindy Eck at (301) 734-0667, e-mail The petition and the draft environmental assessment 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 must 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 and, therefore, should not be a regulated article under APHIS' regulations in 7 CFR part 340. BCS responded to APHIS' subsequent request for additional information and clarification on May 11, 2007. The petition is available for public review and comment.


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 U.S. Department of Agriculture (USDA). APHIS has presented three 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. These are the three alternatives that APHIS is considering: (1) Take no action (GHB614 remains a regulated article), (2) deregulate GHB614 in whole, or (3) deregulate GHB614 in part.

In § 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 to plant parts and plant products whether natural, manufactured, or processed.

GHB614 cotton is subject to regulation by other Federal agencies. 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. In order to be registered as a pesticide under FIFRA, it must be demonstrated that when used with common practices, a pesticide will not cause unreasonable adverse effects in the environment. 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 Start Printed Page 34700are considered to be unsafe unless a tolerance or exemption from tolerance has been established. Residue tolerances for pesticides are established by EPA under the FFDCA, and the U.S. Food and Drug Administration (FDA) enforces the tolerances set by EPA. BCS submitted the appropriate regulatory package to EPA for registering the use of glyphosate herbicide on GBH614 cotton. Safe use of glyphosate has been established by the EPA through the registration of glyphosate for use on cotton and the setting of tolerances for the herbicide.

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. In compliance with the FDA policy, BCS has submitted a food and feed safety and nutritional assessment summary for GHB614 cotton to the FDA. This assessment is pending. As of May 29, 2008, FDA has not announced the completion of BCS' consultation for cotton event GHB614 (see​lrd/​~biocon.html).

National Environmental Policy Act

A draft EA has been prepared to provide the APHIS decisionmaker with a review and analysis of any potential environmental impacts associated with the proposed determination of nonregulated status for GHB614. The draft 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 § 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 draft EA prepared to examine any potential environmental impacts of the proposed determination for the deregulation of the subject cotton event. The petition and the draft EA are available for public review, and copies of the petition and the draft EA are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.

After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information. All public comments received regarding the petition and draft EA will be available for public review. After reviewing and evaluating the comments on the petition and the draft EA and other data, APHIS will furnish a response to the petitioner, either approving (in whole or part) or denying the petition. APHIS will then publish a notice in the Federal Register announcing the regulatory status of BCS' herbicide-tolerant cotton event GHB614 and the availability of APHIS' written regulatory and environmental decision.

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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 12th day of June 2008.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.

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[FR Doc. E8-13736 Filed 6-17-08; 8:45 am]