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The Following Petition Document, 04-362-01P, Contains Three Parts: 1

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The Following Petition Document, 04-362-01P, Contains Three Parts: 1 The following petition document, 04-362-01p, contains three parts: 1. the final revised petition for nonregulated status submitted by Syngenta Seeds, Inc. (Syngenta) on August 2, 2006, for the corn rootworm protected transformation event MIR604 in Zea mays (corn), USDA APHIS number 04-362-01p (which APHIS has deemed complete); 2. a letter of completeness sent to Syngenta by USDA APHIS Biotechnology Regulatory Services (BRS) on July 25, 2006, which identified deficiencies and items to correct in an earlier version of this same petition; and 3. the earlier version of the petition submitted by Syngenta on May 17, 2006. As both versions of the petition are required for readers to understand the questions and responses within the letter of completeness, USDA APHIS BRS has assembled this document with both versions of the petition included. Petition for the Determination of Non-Regulated Status Corn Rootworm Protected Transformation Event MIR604 Revised The undersigned submits this petition under 7 CFR 340.6 to Request that the Administrator, Animal and Plant Health Inspection Service, make a determination that the article should not be regulated under 7 CFR part 340. Submitted by: Henry-York Steiner Regulatory Affairs Manager Syngenta Seeds, Inc. 3054 East Cornwallis Road Research Triangle Park, NC 27709-2257 Phone: (919) 541-8652 Fax: (919) 541-8535 Contributing Authors: Robert Joseph1, Linda Meyer1, Alan Raybould2, John Steffens1, Jeff Stein1 and Demetra Vlachos1 1Syngenta Seeds, Inc., 3054 East Cornwallis Road, Research Triangle Park, NC 27709-2257, USA; 2Syngenta, Jealotts Hill International Research Center, Bracknell, Berkshire, RG42 6EY, UK Date: August 2, 2006 Syngenta Seeds USDA Revised Petition for Non-regulated Status of mCry3A Corn Event MIR604 Page 1 of 234 CLAIM OF DATA CONFIDENTIALITY AND JUSTIFICATION FOR TREATMENT AS CBI The information contained in Appendix 2 to this submission (hereinafter referred to as the “claimed information”) is entitled to treatment as confidential business information (“CBI”), and should be protected against public disclosure. As discussed more fully below, the claimed information consists of valuable trade secret and confidential commercial information, the release of which would cause Syngenta substantial competitive harm. Consequently, this information should be protected against disclosure, pursuant to the Freedom of Information Act, 5 U.S.C. §§ 551 et seq. (“FOIA”). Nature of the Claimed Information The claimed information consists of studies and data that have been developed by Syngenta in support of the commercialization of its new modified Cry3A (mCry3A) maize product. These data have been developed through extensive research, testing and analysis conducted and sponsored by Syngenta over several years, at a cost of several million dollars. These data provide essential product characterization information, key genetic sequence information, as well as information regarding the product’s toxicological profile, its chemical profile, and its environmental fate and safety. Furthermore, these data provide an indispensable “road map” of the studies that are required in order to obtain the regulatory approvals necessary to market the company’s new mCry3A maize product. Most of these studies have already been, or will be, submitted to the U.S. Environmental Protection Agency (EPA) under a claim of confidentiality, in order to obtain regulatory approvals for Syngenta’s Cry 3A product under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. §§ 136 et seq. (“FIFRA”) and the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321, et seq. (“FFDCA”). Basis for Confidentiality Claim The Freedom of Information Act, in Exemption 4, specifically shields from public disclosure the following types of information: trade secrets and commercial or financial information obtained from a person and privileged or confidential. See 5 U.S.C. § 552(b)(4). For purposes of this provision, the courts have defined “trade secret” information to mean a: secret, commercially valuable plan, formula, process, or device that is used for making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. Public Citizen Health Research Group v. FDA, 704 F.2d 1280 (D.C.Cir. 1983). See also, Sokolow v. FDA, No. 1:97-CV-252, slip op at 7 (E.D. Tex. Feb 19, 1998), aff’d 162 F.3d 1160 (5th Cir. 1998) (information regarding the manner in which a drug is manufactured, Syngenta Seeds USDA Revised Petition for Non-regulated Status of mCry3A Corn Event MIR604 Page 2 of 234 including “analytical methods employed to assure quality and consistency” and the “results of stability testing” are trade secret information for purposes of Exemption 4). Similarly, APHIS, in its Policy Statement on the Protection of Privileged or Confidential Business Information, defines “trade secret” to include: production data, formulas, and processes, and quality control tests and data, as well as research methodology and data generated in the development of the production process. 50 Fed. Reg. 38561 (Sept. 23, 1985) (hereinafter referred to as APHIS’s “Policy Statement on CBI”). The claimed information includes essential data pertaining to the formulation, characterization and stability of Syngenta’s new mCry3A maize product. In addition, when examined as a whole, these studies provide a valuable road map of the studies needed to satisfy the data requirements for regulatory approval of the product under FIFRA and the FFDCA, which is an essential aspect of commercialization of the product. All of this information was developed at considerable expense and effort on the part of Syngenta. Accordingly, based on the standards enumerated by the courts and elaborated upon in APHIS’s Policy Statement on CBI, the claimed information is eligible for treatment as “trade secret” information, and should be protected from disclosure under FOIA Exemption 4. In addition, as discussed above, Exemption 4 shields from disclosure “commercial or financial information obtained from a person” that is “privileged or confidential.” For purposes of this exemption, the courts have interpreted the term “commercial information” broadly, to include any information in which an entity has a commercial interest. See Public Citizen Health Research Group v. FDA, 704 F.2d 1280 (D.C. Cir. 1983). Moreover, the courts have found that such commercial information will be deemed “confidential” if its disclosure is “likely to cause substantial harm to the competitive position of the person from whom the information was obtained.” National Parks & Conservation Ass’n v. Morton, 498 F.2d 765 (D.C. Cir. 1974). Similarly, APHIS has explained in its Policy Statement on CBI that: Documents containing commercial or financial information will be deemed confidential if review establishes that substantial competitive harm would result from disclosure. 50 Fed. Reg. 38561. According to the agency, confidential commercial information can include “safety data, efficacy or potency data, and environmental data.” Id. The courts have held that in order to demonstrate that information is confidential commercial information within the scope of Exemption 4, it is sufficient to show that there is actual competition and a “likelihood of substantial competitive injury” if the information is disclosed. See CNA Financial Corp. v. Donovan, 830 F.2d 1132 (D.C. Cir. 1987). Similarly, APHIS has explained in its interpretive guidance that a person seeking to protect confidential commercial information from disclosure must demonstrate that (i) the person faces active competition in the area to which the information pertains, Syngenta Seeds USDA Revised Petition for Non-regulated Status of mCry3A Corn Event MIR604 Page 3 of 234 and (ii) release of the information would cause substantial competitive harm. 50 Fed. Reg. 38561. There is no question that Syngenta faces active competition in its field of agricultural biotechnology, including competition from large multinational corporations such as Monsanto, Dow AgroSciences, Dupont, and others. Many of these competitors are developing or attempting to develop similar products that express insecticidal proteins. Thus, Syngenta satisfies the first criterion for protection of confidential commercial information under Exemption 4. In addition, disclosure of the claimed information would likely result in substantial competitive harm to Syngenta. As alluded to previously, the claimed information consists of data that provide essential product characterization and composition information, as well as information regarding the product’s toxicological profile, its chemical profile, and its environmental fate and safety. These data have been developed through extensive research, testing and analysis, at substantial cost to Syngenta. Access to this product information (including information pertaining to manufacturing and analytical protocols, methods and techniques) could provide our competitors with knowledge that would assist those competitors in developing similar products to compete with Syngenta’s mCry3A product. Moreover, competitors would reap the benefits of Syngenta’s research, thereby accelerating their ability to bring competitive products to market, without having to incur any of the costs of developing those data. In addition, access to the claimed information would provide competitors with commercially valuable insights into the product lines that Syngenta is intending to develop
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