Chemical Producers and Distributors v. Helliker

• Decision Date: 12 May 2004
• Docket Number: No. CV 02-9781 AHM.,CV 02-9781 AHM.
• Court: U.S. District Court — Central District of California
• Parties: CHEMICAL PRODUCERS AND DISTRIBUTORS ASSOCIATION, Plaintiff, v. Paul E. HELLIKER, Director of the California Department of Pesticide Regulation, Defendant. Syngenta Crop Protection, Inc.; Dow Agrosciences LLC; Basf Corporation; Bayer Cropscience LP; E.I. Du Pont De Nemours and Company; and Monsanto Company, Defendants-in-Intervention

319 F.Supp.2d 1116

CHEMICAL PRODUCERS AND DISTRIBUTORS ASSOCIATION, Plaintiff, v. Paul E. HELLIKER, Director of the California Department of Pesticide Regulation, Defendant Syngenta Crop Protection, Inc.; Dow Agrosciences LLC; Basf Corporation; Bayer Cropscience LP; E.I. Du Pont De Nemours and Company; and Monsanto Company, Defendants-in-Intervention

No. CV 02-9781 AHM.

United States District Court, C.D. California.

May 12, 2004.

David H. Bamberger, James P. Rathvon, Piper Rudnick, Washington, DC, Jane H. Barrett, Katherine M. Dugdale, Piper Rudnick, Los Angeles, CA, for Plaintiff.

Todd Alexander Valdes, Office of Attorney General, Los Angeles, CA, for Defendant and Cross Defendant.

Joseph F. Butler, Stanley W. Landfair, McKenna Long & Aldridge, Los Angeles, CA, for Intervenor Defendants and Cross Claimants.

Lawrence S. Ebner, McKenna Long & Aldridge, Washington, DC, for Intervenor Defendants.

ORDER DENYING PLAINTIFF'S SUMMARY JUDGMENT MOTION AND DISMISSING THIS ACTION

MATZ, District Judge.

INTRODUCTION

Chemical Producers and Distributors Association ("Plaintiff") is a voluntary, non-profit trade association consisting of approximately 90 companies involved in the production of generic pesticides.

Paul E. Helliker ("Defendant") is the Director of California's Department of Pesticide Regulation ("DPR"), the state agency charged with enforcing California's pesticide regulation scheme.

Syngenta Crop Protection, Inc., Dow Agrosciences LLC, BASF Corp., Bayer Cropscience LP, E.I. du Pont de Nemours and Co., and Monsanto Co. (collectively, "Intervenors") are pesticide manufacturers who have obtained California registrations for their products in the past. (In their respective briefs, the parties sometimes refer to the Intervenors as "the Basics," in contrast to "the Generics." For purpose of clarity, I will refer to the Intervenors as "the original applicants.")

This matter is before the Court on Plaintiff's Motion for Summary Judgment. Plaintiff contends that the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA") pre-empts Cal. Food & Agric. Code § 12811.5 ("Section 12811.5") because the latter's requirements for registering generic pesticides interfere with Congress's goals in enacting FIFRA. Plaintiff seeks a declaration that FIFRA pre-empts Section 12811.5 and an injunction prohibiting its enforcement. Defendant does not oppose Plaintiff's motion, but the Intervenors do, and in fact they also request that the Court enter summary judgment in their favor, sua sponte.

Pre-emption cases are plentiful and the decisions of the various courts that are asked to apply the doctrine are sometimes hard to reconcile. In cases such as this, where the issue comes down to whether Section 12811.5 frustrates the purposes and/or the implementation of FIFRA, the facts peculiar to the dispute are the decisive consideration. Here, Plaintiff has failed to meet its burden of proving, through facts and evidence, that Section 12811.5 does thwart FIFRA. Accordingly, the Court DENIES Plaintiff's motion. The law does not entitle Plaintiff to a declaratory judgment or an injunction. The Intervenors are entitled to summary judgment.

DISCUSSION

A. The Federal Insecticide, Fungicide, and Rodenticide Act

FIFRA, 7 U.S.C. § 136 et seq., which was enacted in 1947, requires that all pesticides be registered with the Administrator of the Environment Protection Agency ("EPA"), prior to being sold in interstate or foreign commerce.¹ In order to obtain a registration, an applicant is required to submit extensive scientific test data to the EPA, including data establishing that the pesticide is safe for human use and does not harm the environment. 7 U.S.C. § 136a(c)(1)(F); 7 U.S.C. § 136a(c)(2)(A). The EPA keeps this information on file even after it has issued a registration. Id.

In 1972, in response to public concern about the adverse effects of pesticides on human health and the environment, Congress amended FIFRA to provide a more comprehensive regulatory scheme, including regulating pesticides sold in both interstate and intrastate commerce. See Ruckelshaus v. Monsanto Co., 467 U.S. 986, 991-92, 104 S.Ct. 2862, 81 L.Ed.2d 815 (1984). The Supreme Court has described the 1972 amendments as "a comprehensive revision ... [that] transformed FIFRA from a labeling law into a comprehensive regulatory statute." Id. at 991, 104 S.Ct. 2862. Among the changes was that for the first time, an applicant seeking to register a generic version of an already-registered pesticide could submit, and the EPA could consider, the test data submitted by the original applicant, provided the subsequent applicant offered to compensate the original applicant. Id. at 992, 104 S.Ct. 2862.

In 1978 Congress amended FIFRA again. Under the 1978 amendments, an applicant who obtained a federal pesticide registration after September 30, 1978 is entitled to the exclusive use of the test data it submitted to the EPA, for a period of 10 years. That is, the EPA may not consider such data in connection with a subsequent application without the written permission of the original applicant who submitted the data. 7 U.S.C. § 136a(c)(1)(F)(I). After this "exclusive use" period ends, the original applicant's data becomes subject to a mandatory five-year licensing scheme, which allows a later applicant, such as one seeking registration of a generic version of an already-registered pesticide, to rely on the previously-submitted test data — but only if the generic applicant (1) cites the original data in its application and (2) offers to compensate the original applicant. 7 U.S.C. § 136a(c)(1)(F)(iii). During the 5 year mandatory licensing period, if the original applicant and the generic applicant cannot agree on the terms and amount of compensation due, FIFRA provides that their dispute will be resolved in binding arbitration. 7 U.S.C. § 136a(c)(1)(F)(iii). However, even while arbitration is pending, the generic applicant is entitled to rely on the original applicant's data to obtain registration for his generic pesticide. Id. Together, then, the 10 year "exclusive use" and 5 year mandatory licensing periods require a generic applicant to compensate the original applicant for up to 15 years, if the generic applicant seeks to rely on that data the original applicant previously submitted to the EPA. Eventually, after expiration of both the 10-year exclusive use and 5-year mandatory licensing periods, the original applicant's data becomes freely available to generic applicants, who may cite and rely on it to support their federal registration applications without compensating the original applicant. 7 U.S.C. § 136a(c)(1)(F)(iv).

In the 1978 amendments, Congress also added a savings clause to FIFRA, entitled "Authority of States," which explicitly confers limited authority on the states to regulate the registration, sale, use, labeling and packaging of pesticides sold within their borders. 7 U.S.C. § 136v. The savings clause provides, in relevant part:

(a) In general: A State may regulate the sale or use of any federal registered pesticide or device in the State, but only if and to the extent the regulation does not permit any sale or use prohibited by this subchapter.

(b) Uniformity: Such State shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter.

(c)(1) A State may provide registration for additional uses of federally registered pesticides formulated for distribution and use within that State to meet special local needs in accord with the purposes of this subchapter and if registration for such use has not previously been denied, disapproved, or canceled by the Administrator. Such registration shall be deemed registration under section 136a of this title for all purposes of this subchapter, but shall authorize distribution and use only within such State...

B. Cal. Food & Agric. Code § 12811.5

Although under FIFRA sellers and distributors of pesticides are required to obtain federal registration before they can sell or distribute their pesticide anywhere in the country, there is no provision in federal law that entitles them to sell or distribute their products in any given state; once they obtain federal registration, they must also register the pesticide in each state in which they intend to sell or distribute it. See, e.g., Cal. Food & Agric. Code § 12811. Plaintiff contends that most state registration procedures (for both original and generic applicants) are simple; they merely require the submission of routine paperwork, the EPA-approved label for the pesticide and payment of a modest fee.² See Statement of Genuine Issues ("SGI") No. 6; Frazee Decl. ¶ 11; Collier Decl. ¶ 13; Vance Decl. ¶ 9; Kay Decl. ¶ 15.

However, California law is different. Cal. Food & Agric. Code § 12811.5 requires generic applicants to submit to the DPR the same data they submitted to the EPA in support of their application for federal generic registration, including the health and safety test data, in addition to any other information DPR determines to be relevant. See Frazee Decl. ¶ 12-14; Cal.Code. Regs. tit. 3, § 6170(a). Like FIFRA, California law requires a generic applicant either to duplicate the test data previously submitted by an original applicant (sometimes at great expense) or to obtain written permission from the original applicant to cite and rely on the test data the original applicant previously submitted. Section 12811.5 provides, "[D]ata...previously submitted to the [DPR or EPA] to support an application for the original registration of a pesticide or to support an application for an amendment adding any new use to that registration and that pertains solely to that new use shall not, without the written permission of the original data submitter... be considered by the [DPR] to support an application by another person."³ See also Cal.Code Regs. tit. 3, § 6170(c) (...