Syngenta Crop Prot. Inc. v. U.S. Envtl. Prot. Agency

• Decision Date: 09 August 2011
• Docket Number: 1:02CV00334
• Court: U.S. District Court — Middle District of North Carolina
• Parties: SYNGENTA CROP PROTECTION, INC., Plaintiff, v. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, LISA P. JACKSON, Administrator, U.S. Environmental Protection Agency, MAKHTESHIM-AGAN OF NORTH AMERICA, INC., SIPCAM AGRO USA, INC. DREXEL CHEMICAL COMPANY, and AGAN CHEMICAL MANUFACTURERS, LTD. Defendants.

SYNGENTA CROP PROTECTION, INC., Plaintiff, v. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, LISA P. JACKSON, Administrator, U.S. Environmental Protection Agency,

MAKHTESHIM-AGAN OF NORTH AMERICA, INC., SIPCAM AGRO USA, INC.

DREXEL CHEMICAL COMPANY, and AGAN CHEMICAL MANUFACTURERS, LTD. Defendants.

1:02CV00334

UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF NORTH CAROLINA

Dated: August 9, 2011

MEMORANDUM OPINION

I. Procedural Posture

This case is before the Court on several outstanding motions, all of which will be addressed in this Opinion. The outstanding motions are Sipcam Agro USA, Inc.'s ("Sipcam") Motion for Summary Judgment on Syngenta's Claim of Arbitrary and Capricious Agency Action in Violation of the Administrative Procedure Act [Dock. 308], Drexel Chemical Company's ("Drexel") Motion for SummaryJudgment on Syngenta's Claim of EPA Action in Violation of the Equal Protection Clause and Violation of FIFRA's Exclusive Use Provisions [Dock. 312], United States Environmental Protection Agency's and Lisa P. Jackson's (collectively "EPA") Motion for Summary Judgment [Dock. 316], Makhteshim-Agan of North America, Inc.'s ("MANA"¹) Motion to Dismiss for Lack of Subject Matter Jurisdiction [Dock. 317], Syngenta Crop Protection, Inc.'s ("Syngenta"²) Motion for Summary Judgment [Dock. 319], and MANA's Motion to Unseal MANA's Motion to Dismiss for Lack of Subject Matter Jurisdiction and Memorandum of Law in Support [Dock. 342]. Drexel and Sipcam join MANA's motion to dismiss; Drexel joins Sipcam's motion for summary judgment; and Sipcam joins Drexel's motion for summary judgment. The private Defendants (collectively "Metolachlor Registrants") and EPA present overlapping arguments in their motions and accompanying briefs, while Syngenta's response briefs and own motion and accompanying brief offer related arguments. As a result, all motions can effectively be resolved together in one Opinion. For the following reasons, Sipcam's motion for summary judgment, which Drexel joins, is granted; Drexel'smotion for summary judgment, which Sipcam joins, is granted; EPA's motion for summary judgment is granted; MANA's motion to dismiss, which Sipcam and Drexel join, is granted in part and denied in part; Syngenta's motion for summary judgment is denied; and MANA's motion to unseal is granted.

II. Facts

This Court has previously explained the relevant portions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the background of this case in its previous opinions and will not restate those here except where necessary. See, e.g., Mem. Op., Aug. 8, 2006 [Dock. 249]; Mem. Op., July 12, 2004 [Dock. 126].

Metolachlor was first registered in 1976 for general weed control. Administrative Record [hereinafter "AR"] 7 at 6. In the early 1990's, EPA developed a reduced risk initiative with two basic objectives: (1) to create incentives for the development, registration, and use of lower risk pesticides and (2) to encourage the replacement of higher risk pesticides on the market. AR 3. In the meantime, EPA issued Data Call-Ins (DCIs) to then-current metolachlor registrants, including Syngenta, for the submission of data to maintain the registrations. AR 4-6; see 7 U.S.C. § 136a(c)(2)(B) (explaining EPA's authority to require additional data to maintain registrations). However, the registrants did not submit the required data. AR 211 at 3. Although this resulted in data gaps, EPA did not cancel the metolachlor registrations. Id. In 1995, EPA issued its 37Reregistration Eligibility Decision (RED) for metolachlor according to which it found that, with few exceptions, most uses of metolachlor would not cause unreasonable risk to humans or the environment. AR 7 at v.

In 1996, under EPA's reduced risk initiative, Syngenta submitted its application for s-metolachlor which used, in part, bridging data from studies submitted for metolachlor's registration. AR 291 at 1; AR11; see also 7 U.S.C. 136a(c)(10) (explaining expedited registration of pesticides). According to the application, s-metolachlor is as effective at weed control as metolachlor when applied at approximately 62.5 percent of the metolachlor rate. AR 291 at 2. As a result, Syngenta believed s-metolachlor would result in reduced environmental loading. Id. However, because metolachlor was then the second most widely used herbicide in the United States, Syngenta was not prepared to cancel its registration immediately in favor of s-metolachlor. Id. at 3. Instead, Syngenta proposed a three- to five-year phase-in period for s-metolachlor. Id.; AR 9. In order to achieve this, Syngenta requested expedited review of s-metolachlor under the reduced risk initiative. AR 291. While EPA was reviewing Syngenta's application for s-metolachlor, EPA's Environmental Fate and Effects Division (EFED) issued comments on s-metolachlor and determined it to be a reduced risk because of the proposed reduction in exposure. AR 9. On March 14, 1997, EPA conditionallyregistered s-metolachlor³ with an expiration date of February 14, 1998. AR 12; AR 211 att. EPA continued its review of data requirements and submissions for s-metolachlor. See, e.g., AR 13 (summarizing EPA's reviews and Syngenta's responses to those reviews).

After EPA registered s-metolachlor conditionally, Syngenta requested voluntary cancellation of all metolachlor registrations on April 11, 1997. AR 113, Vol. 1 at 27; see also 7 U.S.C. 136d(f)(1)(A) (explaining that a registrant may request a voluntary cancellation of a pesticide registration). Syngenta requested that the cancellation of technical metolachlor be effective July 1999, and the cancellation of formulations containing metolachlor to be effective April 2000. AR 113, Vol. 1 at 27. According to Syngenta, EPA requested that Syngenta withdraw its cancellation requests, which it did. Id. at 28.

In January 1998, Syngenta requested that EPA remove the expiration date of s-metolachlor's registration. AR 12.⁴ Syngenta recognized the registration would remain conditional, however, due to outstanding data requirements. Id. EPA and Syngenta had remained in communication concerning data requirements for s-metolachlor since its registration in March 1997. AR 13-23. In response to Syngenta's request, EPA "reassessed and found [s-metolachlor] acceptable for conditional registration" without an expiration date. AR 15. As part of s-metolachlor's conditional registration without an expiration date, EPA did require that Syngenta submit certain data, including (1) avian reproduction in bobwhite quail study, (2) aquatic invertebrate life-cycle chronic toxicity study, (3) small-scale prospective ground water monitoring study including terrestrial field dissipation,⁵ and (4) fathead minnow life-cycle and early life stage study.⁶ Id. EPA determined the bobwhite quail study with metolachlor was not acceptable and could not be bridged. AR 215. EPA found all chronic fish and invertebrate studies with metolachlor to be invalid or supplemental. Id. Thus, they could not be bridged. Id. Most of these studies had been part of the communications between EPA and Syngenta since at least April 1997. See AR 13. In February 1998, EPA's EFED clarified in a memo to the Registration Division which data gaps had to be filled.

AR 14. In listing those data requirements, EFED included additional requirements not mentioned in its original April 1997 data review. Id. EPA and Syngenta continued to debate data requirements for s-metolachlor at least through January 1999. AR 16-23.

Syngenta resubmitted its request for voluntary cancellation of metolachlor in September 1999. AR 113, Vol. 1 at 28 (suggesting Syngenta sought cancellation of technical and end-use metolachlor); AR 293 (requesting cancellation of Metolachlor Technical). In December 1999, EPA published notice in the Federal Register of the receipt of Syngenta's request to cancel its metolachlor registrations. AR 294; see also 7 U.S.C. § 136d(f)(1)(B), (C) (explaining that EPA must publish in the Federal Register for 180 days notice of its receipt of a request for voluntary cancellation of a pesticide registered for minor agricultural uses and the termination of which would adversely affect its availability). In addition, Syngenta ceased paying maintenance fees for its technical and end-use registrations. See AR 295 (informing Syngenta in February 2000 of EPA's intent to cancel Syngenta's registrations due to failure to pay maintenance fees); AR 301 (informing Syngenta in February 2001 of EPA's intent to cancel Syngenta's registrations due to failure to pay maintenance fees).

Shortly after publication, in January 2000, then-Cedar Chemical Corporation ("Cedar") applied for a me-too registration of Metolachlor Technical dependent upon Syngenta's metolachlor registrations. See AR 29; see also 7 U.S.C. §136a(c)(7)(A) (describing conditional registration of a pesticide or proposed use that is identical or substantially similar to any currently registered pesticide or use thereof and which would not significantly increase the risk of any unreasonably adverse effect on the environment). In response, in March 2000, Syngenta petitioned EPA to deny Cedar's application. AR 25. However, neither Cedar nor Syngenta provided EPA with sufficient information to determine the relative risk of s-metolachlor compared with Metolachlor Technical. AR 52. As a result, EPA requested that both parties submit further data to assist EPA in its determination. Id.

During the period for public comment regarding Syngenta's voluntary cancellation, in June 2000, Cedar submitted objections to the cancellation of Syngenta's products, in part due to Cedar's pending me-too application for Metolachlor Technical. AR 297. Although the public comment period ended in June 2000, EPA did not issue a cancellation order immediately thereafter.

Sipcam applied in October 2000 for a me-too Metolachlor Technical conditional registration dependent, like Cedar's application, on Syngenta's...