Summary of a Recent
Judicial
Development in
Administrative Law
D.C. Circuit Vacates EPA Directive
Issued in Press Release
Gaby R. JabbourNational AgLaw Center Research Assistant
In an action brought by pesticide manufacturers and a trade association against the Environmental Protection Agency ("EPA") challenging a directive that was issued by the EPA in a press release providing that the EPA would no longer consider or rely on third-party human studies when evaluating pesticide safety, the United States Court of Appeals for the District of Columbia vacated the directive because it constituted a binding regulation that should not have been issued without a notice of proposed rulemaking and opportunity for public comment. CropLife America v. E.P.A., 329 F.3d 876, 879 (D.C. Cir. 2003).
For decades, the EPA "accepted and relied upon third-party human data in evaluating pesticide safety." Id. at 879. In the late 1990s, it began reevaluating this practice and began considering such data only on a case-by-case basis. See id. at 878. In 2001, the EPA informed the regulated community that it would consider third-party human data on a case-by-case basis. Id. at 878. On December 14, 2001, however, the EPA reversed this position and issued a directive that stated that
until a policy is in place, the Agency will not consider or rely on any such human studies in its regulatory decision making, whether previously or newly submitted. Should EPA be legally required to consider or rely on any such human study during this interim period, the Agency will assemble a Science Advisory Board subpanel to review and comment on scientific appropriateness and ethical acceptability of the study in question, and the Agency will provide an opportunity for public involvement.
Id at 881 (citation omitted).
Several pesticide manufactures, including CropLife America, and a trade association, (collectively, "petitioners") brought an action against the EPA seeking judicial review of the EPA's directive. See id. The petitioners argued that "the EPA directive [was] unlawful, because it constitute[d] a binding regulation that was issued without the notice of proposed rulemaking and period for public comment mandated by the Federal Food, Drug and Cosmetic Act" ("FFDCA"), 21 U.S.C. §§ 301-395. Id. (citations omitted). The petitioners also argued that "the [new] policy violate[d] the rule, enunciated in both the Federal Insecticide, Fungicide and Rodenticide Act, 7 U.S.C. § 136-136y ("FIFRA"), and FFDCA, requiring EPA to consider all relevant reliable data." Id. (citations omitted). Finally, the petitioners argued that "the policy [was] arbitrary and capricious in violation of the Administrative Procedures Act, 5 U.S.C. §§ 701-706." Id. (citation omitted).
The EPA argued that "the directive . . . [was] not a binding regulation, primarily because of the language allowing EPA to consider third-party human studies if the agency is 'legally required to consider or rely on any such human study.'" Id. at 881. It also argued that "the matter in dispute [was] not subject to judicial review, that [the] petitioners lack[ed] standing, and that the challenge [was] not ripe for review." Id.
The D.C. Circuit stated that "[t]he principal issue in this case [was] whether the EPA directive that is included in the December 14 Press Release constitute[d] a binding regulation." Id. It found that "[t]he disputed directive constitute[d] a binding regulation that [was] directly aimed at and enforceable against [the] petitioners," and noted that "[t]his clear and unequivocal language [of the directive] which reflect[ed] an obvious change in established agency practice, create[d] a 'binding norm' that is 'finally determinative of the issues or rights to which it is addressed.'" Id. (citations and quotation omitted).
The court stated that the directive "[was] binding on [the] petitioners, who are now barred from relying on third-party human studies (even in cases where such studies formerly were approved), and [was] binding on the agency because EPA has made it clear that it simply 'will not consider' human studies." Id. It also stated that "[t]he fact that the directive also notes that third-party human test data can be considered if the agency is 'legally required to consider or rely on such human study' does not at all alter our conclusion." Id.
The court next examined the EPA's argument that the directive was "nothing more than a 'policy statement,' and thus [was] not subject to judicial review." Id. at 883 (citing 21 U.S.C. § 346a(h)(1)). It explained that "[a]s a general matter, the case law reflects two related formulations for determining whether a challenged action constitutes a regulation or merely a statement of policy." Id. "One line of analysis focuses on the effects of the agency action," and "[t]he second line of analysis focuses on the agency's expressed intentions." Id. (citations and quotations omitted).
The court determined that "[t]he directive clearly establishe[d] a substantive rule declaring that third-party human studies [were] now deemed immaterial in EPA regulatory decisionmaking under FFDCA and FIFRA." Id. It also determined that "there [was] little doubt that the directive . . . 'binds private parties [and] the agency itself with the 'force of law.''" Id. (citation omitted). It therefore concluded that the directive "constitute[d] a regulation rather than a policy statement." Id. It vacated the directive "for a failure to engage in the requisite notice and comment rulemaking" and held that "the agency's previous practice of considering third-party human studies on a case-by-case basis . . . is reinstated and remains in effect unless and until it is replaced by a lawfully promulgated regulation." Id. at *8.
The case was decided on June 3, 2003; this summary was posted August, 2003