Ciba-Geigy Corp. v. U.S. E.P.A.

• Decision Date: 09 September 1986
• Docket Number: CIBA-GEIGY,No. 85-5793,85-5793
• Citation: 801 F.2d 430
• Parties: , 255 U.S.App.D.C. 216, 17 Envtl. L. Rep. 20,072 CORPORATION, Appellant, v. U.S. ENVIRONMENTAL PROTECTION AGENCY.
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 430

801 F.2d 430

24 ERC 1841, 255 U.S.App.D.C. 216, 17

Envtl. L. Rep. 20,072

CIBA-GEIGY CORPORATION, Appellant, v. U.S. ENVIRONMENTAL PROTECTION AGENCY.

No. 85-5793.

United States Court of Appeals,

District of Columbia Circuit.

Argued March 10, 1986.

Decided Sept. 2, 1986.

As Amended Sept. 9, 1986.

Appeal from the United States District Court for the District of Columbia (Civil Action No. 85-00795).

Kenneth W. Weinstein, with whom Peter M. Gillon, Washington, D.C., was on the brief, for appellant. Thomas C. Papson, Washington, D.C., also entered an appearance, for appellant.

Laura E. Frossard, Atty., Dept. of Justice, with whom Edward J. Shawaker, Atty., Dept. of Justice, Michael S. Winer and Timothy D. Backstrom, Attys., U.S. E.P.A., Washington, D.C., were on the brief, for appellee. Jacques B. Gelin, Atty., Dept. of Justice, Washington, D.C., also entered an appearance, for appellee.

Before STARR and SILBERMAN, Circuit Judges, and WRIGHT, Senior Circuit Judge.

Opinion for the Court filed by Circuit Judge STARR.

Dissenting Opinion filed by Circuit Judge SILBERMAN.

STARR, Circuit Judge:

Ciba-Geigy Corporation appeals from an order of the District Court dismissing its complaint on grounds of ripeness. The gravamen of Ciba-Geigy's complaint is that the Environmental Protection Agency required it to change the labeling of its registered pesticide, simazine, without affording the Company an adjudicatory hearing required by section 6(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA or Act), 7 U.S.C. Sec. 136d(b) (1982). For the reasons that follow, we conclude that Ciba-Geigy's claim is ripe for review and remand it to the District Court for adjudication.

I

Under FIFRA, all pesticides sold, distributed or received in the United States must be registered by EPA. 7 U.S.C. Sec. 136a(a). An applicant for registration is required to file, among other things, a copy of the labeling of the pesticide and data supporting the product's safety and efficacy. Id. Sec. 136a(c)(1)-(2) (1982 & Supp. II 1984). EPA will not approve a registration unless it determines that the proposed labeling satisfies FIFRA's requirements and that the pesticide "when used in accordance with widespread and commonly recognized practice ... will not generally cause unreasonable adverse effects on the environment." Id. Sec. 136a(c)(5). When it appears that a registered pesticide no longer conforms to these standards, EPA may seek to cancel the product's registration or change its classification. Id. Sec. 136d(b). ¹ Section A separate section of FIFRA renders unlawful the sale, distribution or receipt of "misbranded" pesticides. Id. Sec. 136j(a)(1)(E). The Act provides twelve definitions of a misbranded pesticide, three of which are pertinent here:

6(b) of the Act, however, expressly grants registrants the right to a formal, public hearing and the views of a Committee of the National Academy of Sciences and a Scientific Advisory Panel before the proposed cancellation or classification change takes effect. Id. Sec. 136d(b); see also id. Secs. 136d(d), 136w(d) (1982 & Supp. II 1984).

A pesticide is misbranded if--

the labeling accompanying it does not contain directions for use which are necessary for effecting the purpose for which the product is intended and if complied with ... are adequate to protect health and the environment;

the label does not contain a warning or caution statement which may be necessary and if complied with ... is adequate to protect health and the environment; or

the labeling does not contain a statement of the use classification under which the product is registered.

Id. Sec. 136(q)(1)(F), (1)(G), (2)(B). Misbranded pesticides are subject to seizure, id. Sec. 136k(b)(1)(A), and persons who unlawfully use misbranded pesticides are subject to a " 'stop sale, use, or removal order,' " id. Sec. 136k(a), and civil and criminal penalties, id. Sec. 136l (a), (b).

Ciba-Geigy manufactures and sells chemical products, including the pesticide simazine. Simazine has been registered by EPA since 1957 for use on various agricultural, industrial and aquatic sites to control weeds and algae.

During the 1970's, EPA pursuant to Congressional mandate began the lengthy process of reregistering all pesticides. See id. Sec. 136a(g). In April 1984, EPA promulgated a "Registration Standard" for simazine, setting forth the agency's evaluation of available data and its position regarding the measures necessary to bring simazine into compliance with FIFRA's registration criteria. Joint Appendix (J.A.) at 45-59. In the Registration Standard, EPA expressed concern about simazine contamination of groundwater. On the basis of that potential hazard, EPA directed additional studies to assess fully the environmental effects of simazine prior to its ultimate reregistration. In addition, the Registration Standard imposed a deadline of December 31, 1984, for changing simazine's classification from general use to "restricted use," for changing the product's label to indicate the use restriction, and for including a warning against use of simazine in areas with specified soil and groundwater conditions.

EPA sent a follow-up notice in July to all twenty simazine registrants reiterating the agency's concern about groundwater contamination, the need for interim restrictions on simazine's use, and the need for modification of the product's label. This notice further stated that "[t]he Agency intends to institute cancellation proceedings to cancel under FIFRA section 6(b)(1) all end-use products containing simazine ... not bearing the required labeling changes as specified above by December 31, 1984." J.A. at 61.

On December 21, 1984, EPA advised simazine registrants by mailgram of a revised labeling statement concerning the groundwater hazard and of a new deadline, January 30, 1985, for the labeling change. The opening paragraph of the mailgram concluded with the following warning: "Affected stocks shipped after that date without the required changes will be considered misbranded." J.A. at 62. ² The mailgram also advised registrants that "[i]f In January 1985, Ciba-Geigy's counsel wrote the Director of EPA's Office of Pesticide Programs setting forth Ciba-Geigy's position "that the proposed label changes are unwarranted and therefore [the Company] does not intend voluntarily to implement the requested changes." J.A. at 64. The stated purpose of the letter was to obtain clarification from EPA concerning the procedure by which the agency intended to enforce the label changes. In particular, Ciba-Geigy expressed its understanding that EPA was obliged to follow the registration cancellation process set forth in section 6(b) of FIFRA before it could bring a misbranding action against a pesticide registrant for failure to comply with proposed labeling changes. Ciba-Geigy observed that, despite this statutorily mandated procedure, EPA's December 21 mailgram suggested that EPA could bring an enforcement action for misbranding without first cancelling Ciba-Geigy's existing registration.

                revised labels are not submitted, it will be necessary to take steps to cancel the registration(s)."    J.A. at 63.  After the July and December notices were dispatched by EPA, 17 of the 20 simazine registrants either complied with the new labeling requirements or voluntarily cancelled their registration
                

Shortly after Ciba-Geigy submitted a second request to the agency for clarification in early March 1985, EPA's Director of Pesticide Programs responded by letter advising that "[i]t is the Agency's position that any [simazine] products not bearing the required statement of restricted use classification or groundwater advisory statement and sold, distributed, shipped, or released for shipment by Ciba-Geigy Corporation after January 30, 1985 are misbranded under Secs. 2(q)(1)(F), 2(q)(1)(G), and/or 2(q)(2)(B) of FIFRA" and subject to "appropriate enforcement action concerning misbranded products under FIFRA." J.A. at 69-70. In the letter, the Director expressly warned the registrant that "the Agency does not agree with your interpretation" of FIFRA, namely that the section 6(b) notice and hearing procedures for registration cancellation are the sole means by which EPA may require a registrant to make labeling changes. Id. at 69.

Ciba-Geigy thereupon filed suit in federal district court seeking declaratory and injunctive relief against EPA for imposing labeling changes and use restrictions on a registered product without affording the procedures mandated by section 6(b) of FIFRA. The complaint briefly chronicled the series of mailings through which EPA, in effect, denied Ciba-Geigy a cancellation hearing, including the April 1984 Registration Standard, the July and December 1984 notices and the March 1985 letter. The Company further alleged that since receipt of EPA's December 21 mailgram it had halted shipment of all simazine products which do not satisfy EPA's new labeling requirements; it also asserted that compliance with those requirements would occasion a 50 percent loss in sales because users would instead turn to unrestricted alternative herbicides. ³

Two days after Ciba-Geigy filed suit, EPA sent another letter to the Company. J.A. at 71-72. This letter reaffirmed EPA's position that under FIFRA the agency enjoys authority to require all simazine registrants to provide the groundwater contamination warning on the label by threatening immediate EPA enforcement action for misbranding under sections 2(q)(1)(F) and 2(q)(1)(G) of the Act. ⁴ On cross-motions for summary judgment and EPA's motion to dismiss for lack of ripeness, the District Court dismissed the complaint on the ground that EPA "has neither issued a final order directed to the plaintiff Ciba-Geigy nor taken any other final action which is reviewable by the Court." 607 F.Supp. 1467, 1468 (D.D.C.1985). Although recognizing that the "complaint stems from a series of...