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SDS BIOTECH CORP. v. EPA

June 27, 1985

SDS BIOTECH CORPORATION, Plaintiff
v.
ENVIRONMENTAL PROTECTION AGENCY, ET AL., Defendants



The opinion of the court was delivered by: GREENE

 HAROLD H. GREENE, United States District Judge.

 At issue in this case are the pesticide registration requirements of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. §§ 136-136y (1980). Plaintiff, SDS Biotech Corporation, holds a number of pesticide registrations for chlorothalonil products. Defendant, Griffin Corporation, holds two conditional chlorothalonil registrations. The Environmental Protection Agency (EPA), also a defendant, is responsible for administering the registration program.

 The history of this case is somewhat complicated. SDS Biotech obtained the first registrations for chlorothalonil in 1966. In 1972, Congress amended FIFRA establishing a new standard for review of pesticide registrations and requiring EPA to reregister pesticides under the new standards. 7 U.S.C. § 136a(g). During the reregistration process, EPA was not required to cancel existing registrations, even though those registrations had been issued utilizing fewer data than the amended Act would require for a new registration. This resulted in an anomalous situation whereby new applicants were denied registrations to market pesticides identical to products already on the market because they could not meet the Act's more stringent data requirements. To remedy this anticompetitive effect, Congress amended FIFRA again in 1978 and created the conditional registration program whereby new applicants who wished to market products substantially similar to products already on the market were given conditional registrations. They were permitted to market pesticides even though certain data was missing "under such conditions as will require the submission of such data not later than the time such data are required to be submitted with respect to similar pesticides already registered under this [Act]." 7 U.S.C. § 136a(c)(7)(A).

 In this case, EPA determined that additional data was required on the teratological risk related to chlorothalonil and it issued a data call-in notice on September 14, 1981. This notice required registrants of pesticide products containing chlorothalonil to provide teratogenicity studies 26 months after receipt of the notice. *fn1" EPA did not send a notice of the data call-in to Griffin Corporation because in September 1981, Griffin was not a registrant. On November 19, 1981, and on January 1, 1983, EPA issued conditional registrations to Griffin for end-use and technical chlorothalonil products. Again, no mention was made by EPA that a data call-in notice had been issued and that Griffin was required to submit data at the same time that other registrants were required to submit data.

 In April 1983, a portion of FIFRA relevant to these proceedings was declared unconstitutional by a District Court and its enforcement enjoined. *fn2" Section 136a(c)(1)(D), the operation of which was enjoined by the District Court, established a system under which data supplied by one applicant could be used to support other applications, provided that an offer to compensate the original data supplier was made. This procedure was intended to reduce duplicative research and encourage cooperative ventures. It also provides a relatively simple procedure by which new applicants could receive a registration -- they could cite data previously generated, offer to pay, and be credited with submission of that data. A compulsory arbitration system is also in place to deal with disputes over the amount of compensation.

 On July 7, 1983, SDS submitted its information on teratology and on the basis of its compliance with the data call-in, its registration was continued in force. Griffin states that it first discovered the data call-in requirement in November 1983 and thereby found that it was in a situation where it was unable to generate the data by the deadline and was enjoined from using the normal statutory citation/offer to pay procedure. Griffin did make an offer to pay SDS for the citation of its data on December 12, 1983.

 EPA did not take action to cancel Griffin's registration, stating that it was deferring any decision on whether Griffin had failed to comply with its conditions of registration until after the Monsanto and Union Carbide litigation was resolved. On March 8, 1984, SDS filed this action to compel EPA to cancel Griffin's registration and on June 8, 1984, this Court issued a stay of proceedings in this case pending the outcome of the Monsanto case.

 The injunctions in the Monsanto and Union Carbide cases were finally resolved on October 9, 1984. *fn3" EPA thereupon took steps to reinstitute the FIFRA procedures permitting citation to earlier submitted data. In December 1984, Griffin filed an application to amend its chlorothalonil registration, cited the SDS data on teratology, as well as other data in EPA files and offered to pay SDS compensation for the use of its data. On February 8, 1985, EPA issued the amended registrations to Griffin.

 Presently before the Court are cross-motions for summary judgment and EPA's motion to dismiss as moot. Oral argument was held on May 17, 1985, and this case is now ripe for decision.

 The Court is of the view that this case is moot and must therefore be dismissed as there is no continuing case or controversy. The test for mootness was set out by the Supreme Court in County of Los Angeles v. Davis, 440 U.S. 625, 59 L. Ed. 2d 642, 99 S. Ct. 1379 (1979). See also, Doe v. Harris, 225 U.S. App. D.C. 27, 696 F.2d 109 (D.C. Cir. 1982). A case is moot if the court concludes with assurance that there is no reasonable expectation that the alleged violation will recur and if interim relief or events have completely and irrevocably eradicated the effects of the alleged violation.

 The alleged violation in this case was Griffin's failure to submit or cite teratology data at the time such data was due under the data call-in. Under the statute, the remedy for this violation would be for Griffin to submit or cite such data by the due date or for EPA to cancel the Griffin registration. If Griffin cited data submitted by SDS, that company would also have the right under the statute to an irrevocable offer to pay compensation.

 At the time the data was due, one of the statutory remedies had been declared unconstitutional and cancellation was the only available remedy. EPA therefore deferred action until the injunctions were vacated and then permitted Griffin to amend its registration, cite SDS teratology data and make an irrevocable offer to pay.

 Analyzed under the Davis test, it is clear that there is no reasonable expectation that the alleged violation will recur. The situation was a highly unusual one in which a portion of the statute was declared unconstitutional and enjoined while the remainder of the statute remained in effect. Of the two procedures envisaged by Congress, only one, cancellation, remained as a viable option. EPA accordingly decided to defer any action until the conclusion of the Monsanto case and at that point permitted ...


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