Syngenta Crop Protection, Inc. v. U.S.E.P.A.
| Decision Date | 08 August 2006 |
| Docket Number | No. 1:02CV334.,1:02CV334. |
| Citation | 444 F.Supp.2d 435 |
| Parties | SYNGENTA CROP PROTECTION, INC., Plaintiff, v. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, Stephen L. Johnson, Administrator U.S. Environmental Protection Agency, Makhteshim—Agan of North America, Inc., Sipcam Agro USA, Inc., Drexel Chemical Company, and Albaugh, Inc., Defendants. |
| Court | U.S. District Court — Middle District of North Carolina |
Amy L. Bircher, Stanley B. Green, Womble Carlyle Sandridge & Rice, Winston-Salem, NC, Harold L. Segall, Kathryn E. Szmuszkovicz, Beveridge & Diamond, P.C., Washington, DC, R. Howard Grubbs, Womble Carlyle Sandridge & Rice, PLLC, Greenville, SC, for Plaintiff.
Anna Mills S. Wagoner, Gill P. Beck, John W. Stone, Jr., U.S. Attorney's Office, David William Sar, Jessica Mollie Marlies, Stanley Leigh Rodenbough, IV, Brooks, Pierce, McLendon, Humphrey & Leonard, James W. Miles, Jr., Ronda Lovell Lowe, Hunter, Higgins, Miles, Elam & Benjamin, PLLC, Greensboro, NC, Gautam Srinivasan, U.S. Environmental Protection Agency, Martha C. Mann, Norman L. Rave, Jr., U.S. Dept. of Justice, Brian A. McGill, Christopher M. Lahiff, McDermott, Will & Emery, David B. Weinberg, Tracy A. Heinzman, Wiley, Rein & Fielding, Washington, DC, Allen T. Malone, C. Thomas Cates, Melissa A. Maravich, Burch, Porter & Johnson, PLLC, Memphis, TN, Ashley Lee Hogewood, III, Kennedy, Covington, Lobdell & Hickman, LLP, Alan D. McInnes, Kilpatrick Stockton, L.L.P., Raleigh, NC, for Defendants.
This suit arises from a dispute between Plaintiff Syngenta Crop Protection, Inc. ("Syngenta") and Defendants United States Environmental Protection Agency and its Administrator, Stephen L. Johnson1 (collectively "EPA"), Makhteshim-Agan of North America, Inc. ("MANA"), Sipcam Agro USA, Inc. ("Sipcam"), Drexel Chemical Company ("Drexel"), and Albaugh, Inc. ("Albaugh"), regarding registrations with the EPA of the pesticide metolachlor. This case is currently before the Court on the following motions: (1) Defendant EPA's Motion for Partial Judgment on the Pleadings [Doc. # 153]; (2) Defendant Sipcam's Motion to Dismiss [Doc. # 141]; and (3) Defendant MANA's Motion to Dismiss [Doc. # 169].2 For the reasons which follow, EPA's Motion for Partial Judgment on the Pleadings and Sipcam's Motion to Dismiss will be GRANTED in part and DENIED in part; and Defendant MANA's Motion to Dismiss will be DENIED.
The background facts surrounding this dispute are provided below. Part A addresses the general procedures for registering a pesticide under The Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), 7 U.S.C. §§ 136, et seq. Part B discusses the parties and the particular pesticide registrations at issue in this case.
FIFRA governs the sale, distribution, and use of pesticides. In general, FIFRA requires that a pesticide be registered with EPA before it can be sold or distributed. FIFRA § 3(a), 7 U.S.C. § 136a(a). As part of the FIFRA registration process, an applicant must meet EPA's data requirements by submitting numerous scientific studies showing that the use of the pesticide in question will not cause unreasonable adverse effects to humans or the environment. Whether or not unreasonable adverse effects are posed is determined through reference to the economic, social, and environmental costs and benefits of the use of the pesticide. FIFRA § 2, 7 U.S.C. § 136(bb).
Different types of registrations are available under FIFRA. For an "unconditional" registration to be issued, an applicant must show that the pesticide will perform its intended function without unreasonable adverse effects on the environment. FIFRA § 3(c)(5)(D), 7 U.S.C. § 136a(c)(5)(D). "Conditional" registrations are also available in certain situations. A conditional registration of a pesticide containing an active ingredient that is not contained in any currently registered pesticide is governed by FIFRA § 3(c)(7)(C). 7 U.S.C. § 136a(c)(7)(C). A conditional registration of a pesticide identical or substantially similar to an already registered pesticide is known as a "metoo" or "follow-on" registration, and is governed by FIFRA § 3(c)(7)(A). 7 U.S.C § 136a(c)(7)(A). For a pesticide to receive a conditional me-too registration, the registration of the original pesticide upon which it is based must still be active.
A me-too applicant can meet FIFRA's data requirements in one of three ways: (1) by providing new data, (2) by the "citeall" method in which the applicant provides a general citation to all of EPA's files, or (3) by the "selective cite" method in which the applicant selectively cites the data of others. See 40 C.F.R. § 152.86 (cite-all method); 40 C.F.R. § 152.90 (selective method). However, under certain circumstances, a me-too registration may be issued to an applicant who has not yet submitted all required data. If the unconditional registrant of the identical/similar pesticide upon which the me-too application relies has not submitted particular required data because that data has not yet been generated, the me-too applicant also need not immediately submit that data. FIFRA § 3(c)(7)(A), 7 U.S.0 § 136a(c)(7)(A). However, the applicant must submit the data by the same date by which the original registrant must do so. Id.
Once a registration is received, the holder typically will continue to submit such studies during the life of the registration to address new scientific developments and changing EPA standards. This process is generally very costly, particularly for a registrant of a new pesticide (one not based on an already existing registration).
In recognition of the expense associated with registration of a pesticide, FIFRA includes provisions that protect proprietary rights in certain data submitted to support an application. Specifically, FFRA § 3(c)(1)(F)(i) provides applicants that register pesticides with new active ingredients the right to "exclusive use" of any data used to support the registration of that new ingredient. 7 U.S.C. § 136a(c)(1)(F)(i). The exclusive use protection lasts for a period of ten years, but can be extended in certain circumstances.
FIFRA § 3(c)(1)(F)(ii), 7 U.S.C. § 136a(c)(1)(F)(ii). During the exclusive use period, only the original applicant may use the data. EPA will deny an application supported by exclusive use data where the applicant is not the original applicant and owner of the data or has not received the consent of the original applicant to use the data. FIFRA § 3(c)(1)(F)(I), 7 U.S.C. § 136a(c)(1)(F)(I).
FIFRA includes several provisions designed to protect a registration holder's exclusive use rights. EPA is required to provide thirty days advance notice to the holder if his exclusive use data is relevant to another application that EPA intends to grant. 40 C.F.R. § 152.116(a). Upon request by the holder and within 30 days of the holder's receipt of such notice, EPA is to "provide the applicant's list of data requirements and method of demonstrating compliance with each data requirement." Id. The holder may then choose to challenge the issuance of a registration to the applicant through petitioning EPA in the manner outlined in 40 C.F.R. § 152.99(b) & (c). 40 C.F.R. § 152.116(b). EPA may then either accept the holder's petition by denying the applicant's registration or deny the holder's petition, a final agency (EPA) action, by issuing the applicant's registration. Id. Pursuant to FIFRA §§ 16(a) and (c), such final agency actions are reviewable by a district court. 7 U.S.C. §§ 136n(a) & 136n(c).
Plaintiff Syngenta is a manufacturer and distributor of pesticides. In 1976, Syngenta's predecessor4 registered the pesticide metolachlor with EPA. Metolachlor is a grass herbicide used to control broadleaf and annual grassy weeds in various crops, trees, and turf. To develop, register, and maintain registration for metolachlor, Syngenta conducted numerous studies at a cost of millions of dollars.
In 1996, Syngenta submitted an application to EPA for registration of a new pesticide, S-metolachlor. S-metolachlor and metolachlor are chemically similar, and are designed for the same types of application and use. However, each has a different active ingredient, and, according to Syngenta, a lower application quantity of S-metolachlor can provide the same pesticidal efficacy as a higher quantity of metolachlor. In addition, Syngenta alleges that S-metolachlor, as compared to metolachlor, poses less toxicity to the environment without sacrificing efficacy, and is therefore considered a "reduced risk" pesticide.
The application for S-metolachlor was submitted under the "reduced risk pesticide" procedures and therefore given an expedited review. See FIFRA § 3(c)(10)(B), 7 U.S.C. § 136a(c)(10)(B). Because of the expedited review process, EPA did not conclude its review of the data submitted in support of S-metolachlor before issuing Syngenta a registration. Smetolachlor had a new active ingredient, and was therefore issued a conditional registration under FIFRA § 3(c)(7)(C).
Upon further review of the data submitted in support of S-metolachlor, EPA determined that certain data requirements were unfulfilled, and set deadlines for submission of such data. In response, on December 20, 1999, Syngenta submitted three ecotoxicity studies: (1) the Avian Reproductive Study of the Bobwhite Quail, (2) the Acute Myside Shrimp Study, and (3) the Fathead Minnow Life-Cycle and Early Life Stage Study.
When EPA granted Syngenta's registration of S-metolachlor it requested that Syngenta voluntarily cancel its metolachlor registrations in order to motivate consumers to use the new, less harmful pesticide.5 Syngenta complied with the request and ceased the manufacture and sale of metolachlor by September 1999. On December 27, 1999, EPA publicly announced the proposed cancellation of all metolachlor registrations and stated that the cancellation would be...
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