Syngenta Crop Protection, Inc. v. United States Environmental Protection Agency

222 F.R.D. 271, 59 ERC (BNA) 1185, 2004 U.S. Dist. LEXIS 13173
CourtDistrict Court, M.D. North Carolina
DecidedJuly 12, 2004
DocketNo. 1:02 CV 334
StatusPublished
Cited by5 cases

This text of 222 F.R.D. 271 (Syngenta Crop Protection, Inc. v. United States Environmental Protection Agency) is published on Counsel Stack Legal Research, covering District Court, M.D. North Carolina primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Syngenta Crop Protection, Inc. v. United States Environmental Protection Agency, 222 F.R.D. 271, 59 ERC (BNA) 1185, 2004 U.S. Dist. LEXIS 13173 (M.D.N.C. 2004).

Opinion

MEMORANDUM OPINION

TILLEY, Chief Judge.

On April 29, 2002, Plaintiff Syngenta Crop Protection, Inc. (“Syngenta”) filed suit against Defendants United States Environmental Protection Agency and its Administrator, Christine Todd Whitman (collectively “EPA”), Cedar Chemical Corp. (“Cedar”), TRI Chemicals, Inc. (“TRI”), Sipcam Agro USA, Inc. (“Sipcam”), and Drexel Chemical Company (“Drexel”). The Complaint seeks injunctive and declaratory relief and alleges that EPA issued pesticide registrations in violation of the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. § 136, et seq.

Numerous motions in this matter are now pending, the following of which are addressed in this Memorandum Opinion: Syn-genta’s Updated Motion for Leave to Amend and Supplement its Complaint [Doc. # 120], Syngenta’s Motion for Leave to Amend and Supplement its Complaint and for Substitution of Party [Doc. # 106], EPA’s Motion, with consent, for Leave to Amend its Answer [Doc. # 73], Syngenta’s Motion to Dismiss all Claims against TRI and for the Withdrawal of TRI from the Case [Doc. # 80], Drexel’s Motion for Joinder to Defendant EPA’s Motion for Partial Dismissal of Complaint and Defendant Sipcam’s Motion to Dismiss Syn-genta’s Third and Fourth Claims for Relief [Doc. # 58], and EPA’s Motion for Supplementation of the Administrative Record [Doc. # 76]. The remaining pending motions will be addressed in future memorandum opinions.

Syngenta’s Motion to Dismiss all Claims against TRI and for the Withdrawal of TRI from the Case is unopposed and will be GRANTED.1 This Court allows Drexel to join the motions to dismiss by EPA and Sipcam [Docs. # 48 & 52] and to adopt the [273]*273accompanying briefs filed by EPA and Sip-cam. Therefore, Drexel’s Motion for Joinder will be GRANTED. Aso, EPA’s Motion for Supplementation of the Administrative Record is unopposed and will be GRANTED.

Further, for the reasons stated below, Syn-genta’s Updated Motion for Leave to Amend and Supplement its Complaint will be GRANTED in full. As a result, two motions will be rendered MOOT: (1) Syngenta’s previous Motion for Leave to Amend and Supplement its Complaint and for Substitution of Party, and (2) EPA’s Motion for Leave to Amend its Answer.2

I.

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 addresses the parties and the particular pesticide registrations at issue.

A.

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).

In addition, “conditional” registrations are 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 “me-too” 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 follow-on registration, the registration of the original pesticide upon which it is based must still be active.

A follow-on applicant can meet FIFRA’s data requirements in one of three ways: (1) by providing new data, (2) by the “cite-all” 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 follow-on 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 follow-on application relies has not submitted particular required data because that data has not yet been generated, the follow-on applicant also need not immediately submit that data. FIFRA § 3(c)(7)(A), 7 U.S.C § 136a(c)(7)(A). However, the applicant must submit the data by the same date by which the original registrant must do so. Id.

A follow-on conditional registration may be issued by EPA only if the registration “would not significantly increase the risk of any unreasonable adverse effect on the environment.” Id. When making this determination, the focus should be on the amount of incremental risk. Therefore, the development of a less harmful alternative is a factor that can [274]*274alter the analysis. Once a less harmful alternative is registered, it will be more difficult for a follow-on applicant to obtain registration of a pesticide that is based on the older, more harmful pesticide.

Regardless of the type of registration sought, an applicant must at least provide some data showing that the registration will not cause unreasonable adverse effects to humans or the environment. In addition, 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.

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222 F.R.D. 271, 59 ERC (BNA) 1185, 2004 U.S. Dist. LEXIS 13173, Counsel Stack Legal Research, https://law.counselstack.com/opinion/syngenta-crop-protection-inc-v-united-states-environmental-protection-ncmd-2004.