Rohm and Haas Co. v. United States Environmental Protection Agency

No. 86-0980 (D.D.C. April 15, 1986)

The court holds that the decision of the Environmental Protection Agency (EPA) to register the soybean pesticide of plaintiff's competitor under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) did not violate FIFRA's exclusive use provision, 7 U.S.C. § 136a(c)(1)(D)(1), nor does it violate EPA's regulations. The court first holds that EPA's decision to register the pesticide Tackle did not violate FIFRA's exclusive use provision. Plaintiff's competitor provided, and EPA relied upon, data independent from the evidence plaintiff had included in its earlier registration application. Moreover, FIFRA's exclusive use provision does not require a competitor to make an identical data submission to that of an earlier- registered manufacturer before EPA may register the second pesticide. The court holds that EPA did not violate its own regulations by not requiring the second applicant to submit the additional tests it had required of plaintiff. EPA determined that the applicant had satisfied all registration requirements, a determination that involves scientific and regulatory expertise. Also, the four tests EPA required of plaintiff but not of its competitor are only required upon findings of crop pesticide residues, and the competitor's data showed no such crop residues. Although EPA has set a tolerance for the active ingredient in plaintiff's and its competitor's pesticides, the regulations do not require that additional tests be conducted whenever a tolerance has previously been set. The court notes that plaintiff's failure to show a substantial likelihood of success on the merits makes it unnecessary to determine whether plaintiff would be irreparably harmed absent injunctive relief. Nonetheless, it expresses doubt that plaintiff could establish irreparable injury, as plaintiff has a potential legal remedy under the Tucker Act, if it is correct on the merits, for a taking of private property for a public use.

Counsel for Plaintiff
Patrick M. Raher
Hogan & Hartson
815 Connecticut Ave. NW, Washington DC 20036
(202) 331-4500

Counsel for Defendant
Marilyn Perry Jacobsen
Department of Justice
10th & Constitution Ave. NW, Washington DC 20530
(202) 633-2000

[16 ELR 20924]

Johnson, J.:

Memorandum Opinion

This action rises under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. §§ 136-136y (FIFRA), and the Administrative Procedure Act, 5 U.S.C. §§ 701-706 (APA). Jurisdiction exists pursuant to 28 U.S.C. § 1331. On April 10, 1986, plaintiff Rohm and Haas Company (Rohm and Haas) filed a complaint for declaratory and injunctive relief, together with an application for a temporary restraining order (TRO), presently under consideration, challenging the decision of the United States Environmental Protection Agency (EPA) to grant a registration on Monday, April 14, 1986, to Rhone-Poulenc Inc. (Rhone-Poulenc)^* for its soybean pesticide, Tackle. In brief, plaintiff contends that EPA's decision to register Tackle violates the exclusive use provision of FIFRA and applicable EPA regulations, that it will be irreparably harmed by the granting of such registration, and that the public interest may be adversely affected. Upon consideration of plaintiff's application, the oppositions thereto of EPA and Rhone-Poulenc, the legal memoranda, affidavits, and exhibits, together with the arguments of counsel heard in open court, it is concluded, for the reasons set forth herein, that Rohm and Haas is not entitled to the relief requested and that its application for a TRO must, therefore, be denied.

A temporary restraining order is an extraordinary, equitable remedy that may be granted only upon a clear showing of entitlement to such relief. The standards for determining whether a party is entitled to injunctive relief are well established and set forth in Virginia Petroleum Jobbers Association v. Federal Power Commission, 259 F.2d 921 (D.C. Cir. 1958). Under that case, the Court must consider the following four factors:

(1) Has the petitioner made a strong showing it is likely to prevail on the merits of its appeal? Without such a substantial indication of probable success, there would be no justification for the court's intrusion into the ordinary processes of administration and judicial review. (2) Has the petitioner shown that without such relief, it will be irreparably injured? . . . (3) Would the issuance of a stay substantially harm other parties interested in the proceedings? . . . (4) Where lies the public interest?

Id., at 925. Consideration of these factors in the context of the instant case convinces the Court that the issuance of a TRO is not warranted because plaintiff has failed to demonstrate that it has a substantial likelihood of success on the merits or that it will be irreparably injured by EPA's granting Rhone-Poulenc a registration for its pesticide.

It must be noted at the outset in analyzing the merits that judicial review of EPA's determination to register Rhone-Poulenc's pesticide, Tackle, is limited to determining whether the Agency's decision was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. 5 U.S.C. § 706. This standard of review is highly deferential and the Court must uphold the Agency's [16 ELR 20925] action if a rational basis exists for the Agency's decision. Ethyl Corp. v. Environmental Protection Agency, 541 F.2d 1 [6 ELR 20267] (D.C. Cir. 1976), cert. denied, 426 U.S. 941 (1976). A court will defer in even greater measure to an agency's determination in areas requiring the application of scientific or technical expertise. Federal Power Commission v. Florida Power & Light Co., 404 U.S. 453 (1972). As the decision challenged here is one involving the EPA's expertise in pesticide regulatory matters, which necessarily includes the evaluation of what scientific and technical data are required to support an application for registration of a pesticide, it is entitled to great deference from the Court.

Plaintiff argues that EPA's decision to register Tackle violates the exclusive use provision of FIFRA, 7 U.S.C. § 136a(c)(1)(D)(i), and is not in accordance with EPA regulations governing pesticide registration contained in 40 C.F.R. Parts 152 and 158. The Court is not persuaded by these arguments. The exclusive use provision simply requires that a subsequent applicant (for registration of a pesticide containing the same active ingredient that was initially registered by an original date submitter such as Rohm and Haas) generate its own data in support of its registration application. Plaintiff's exclusive use rights likely would be violated only if Rhone-Poulenc or EPA relied on data submitted by Rohm and Haas to fulfill data requirements that Rhone-Poulenc failed to satisfy on its own. The Agency affidavits and exhibits submitted by defendants indicate the EPA, in determining to grant registration for Tackle, relied on the data submitted by Rhone-Poulenc and not on the exclusive use data earlier submitted by plaintiff in support of the application to register its pesticide, Blazer. It should also be noted here that, contrary to plaintiff's contention, there is nothing in the exclusive use provision which requires a subsequent applicant to exactly duplicate the original submitter's data package before EPA may determine the former's application is sufficient for registration.

Plaintiff's further contention that EPA violated its own regulations by not requiring Rhone-Poulenc to submit the four additional tests that Rohm and Haas was required to submit in support of its Blazer application is similarly not persuasive in light of the Agency affidavits stating that EPA has determined that Rhone-Poulenc has submitted a complete registration application and complied with all applicable data requirements. A determination such as this, which involves the application of scientific and technical expertise, is one uniquely within EPA's regulatory jurisdiction. Moreover, the four tests which plaintiff contends Rhone-Poulenc must submit in order for its Tackle application to be complete are conditionally-required tests. Plaintiff was required to conduct these additional tests earlier in support of its registration application for Blazer because its initial, required data indicated the presence of residues on crops treated with Blazer, thereby triggering, under the applicable regulations, the conditionally-required tests. Rhone-Poulenc's data indicated that there were no detectable residues on crops treated with Tackle and EPA has determined that Rhone-Poulenc's residue tests are valid and reliable. Although a tolerance has been set by EPA for acifluorfen^* as a result of plaintiff's residue tests, there is nothing in the applicable regulations requiring that these additional tests be conducted whenever a tolerance has previously been set for a particular chemical. For the foregoing reasons, the Court concludes that plaintiff has failed to demonstrate that it has a substantial likelihood of success on the merits.

A few words concerning irreparable injury are necessary. Plaintiff's argument in this regard relies entirely on its argument on the merits. It contends that violation of its exclusive use rights is "irreparably harmful per se." As the Court has already found that plaintiff has failed to show that it is likely to prevail on the merits of its claim that EPA has violated its exclusive use rights, it need not determine whether irreparable injury may be presumed from a violation of FIFRA's exclusive use provision. The Court does note, however, that plaintiff may have an adequate legal remedy in the event it is correct on the merits. The Supreme Court's decision in Ruckelshaus v. Monsanto Co., 104 S. Ct. 2862 [14 ELR 20539] (1984), indicates that plaintiff may have a legal remedy under the Tucker Act, 28 U.S.C. § 1491, for a taking of its property for a public use. As the Court observed in Virginia Petroleum Jobbers, "[t]he possibility that adequate compensatory or other corrective relief will be available at a later date, in the ordinary course of litigation, weighs heavily against a claim of irreparable harm." Id., at 925. Thus, there is serious doubt that plaintiff could establish irreparable injury entitling it to injunctive relief even if it were correct on the merits.

As the Court has concluded that plaintiff's inadequate showing with respect to the probability of success on the merits and irreparable injury prevents the issuance of injunctive relief, the remaining factors of the four-part test of Virginia Petroleum Jobbers, supra, need not be considered and plaintiff's application for a temporary restraining order must be denied.

* The unopposed motion of Rhone-Poulenc to intervene as a defendant herein was granted on April 11, 1986, at the hearing on plaintiff's motion for a TRO.

* Aciflouren is the active ingredient in both Blazer and Tackle.