329 F.3d 876 (D.C. Cir. 2003), 02-1057, Croplife America v. E.P.A.

Docket Nº:02-1057
Citation:329 F.3d 876
Case Date:June 03, 2003
Court:United States Courts of Appeals, Court of Appeals for the District of Columbia Circuit

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329 F.3d 876 (D.C. Cir. 2003)





No. 02-1057

United States Court of Appeals, District of Columbia Circuit

June 3, 2003

Argued March 17, 2003

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[Copyrighted Material Omitted]

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On Petition for Review of an Order of the Environmental Protection Agency


Kenneth W. Weinstein argued the cause for petitioners. With him on the brief was Alexandra A. E. Shapiro .

Seth A. Goldberg argued the cause for intervenor American Chemistry Council. With him on the briefs was Cynthia L. Taub .

Daniel M. Flores, Attorney, U.S. Environmental Protection Agency, argued the cause for respondent. Christopher S. Vaden and Kent E. Hanson, Attorneys, entered appearances.

Aaron Colangelo argued the cause for intervenor Natural Resources Defense Council. With him on the brief was Erik D. Olson.

Joseph W. Hatchett, Lee Davis Thames and Jerry C. Hill were on the brief for amicus curiae Florida Citrus Mutual, et al., in support of petitioners.

Benjamin S. Sharp was on the brief for amicus curiae Washington State Potato Commission in support of petitioners.

Before: GINSBURG, Chief Judge, and EDWARDS and GARLAND, Circuit Judges.

HARRY T. EDWARDS, Circuit Judge :

This case concerns an Environmental Protection Agency (''EPA'' or ''the agency'') directive banning agency consideration of ''third-party'' human studies in evaluating the safety of pesticides. In the late 1990s, EPA began reevaluating its practice of relying on data from third-party human studies, and began considering such data on a case-by-case basis only. In October 2001, the agency made this case-by-case practice clear to the regulated community. Then, however, the agency abruptly reversed its position. On December 14, 2001, EPA issued a directive in a Press Release, announcing that, pending review by the National Academy of Sciences (''NAS'' or ''Academy'') of the ethical issues posed by EPA's use of third-party human studies, ''the Agency will not consider or rely on any such human studies in its regulatory decision making, whether previously or newly submitted.'' Environmental Protection Agency, Press Release, Agency Requests National Academy of Sciences Input on Consideration of Certain Human Toxicity Studies; Announces Interim Policy, Dec. 14, 2001, Appendix (''App.'') 120 (''Press Release'').

Petitioners CropLife America, et al. pesticide manufacturers and a trade association that claims that its members will be adversely affected by the announced moratorium- seek review of the directive in the December 14 Press Release. Petitioners contend that the EPA directive is unlawful, because it constitutes 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, 21 U.S.C.§ 301 et seq. (''FFDCA''). See 21U.S.C. §§ 346a(e)(1)(C) & (e)(2); see also 5 U.S.C. § 553. Petitioners also argue that the policy violates 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. See 7U.S.C. § 136a-1(g)(1); 21 U.S.C. § 346a(b)(2)(D). Finally, petitioners assert that the policy is arbitrary and capricious in violation of the Administrative Procedure Act, 5 U.S.C. §§ 701-706. See 5 U.S.C. § 706(2)(A) (''The reviewing court shall . . .. hold unlawful and set aside agency action, findings, and conclusions found to be . . .. arbitrary, capricious, an abuse of discretion, or Page 879

otherwise not in accordance with law. . ..''). We hold that EPA's directive constitutes a binding regulation issued without notice and the opportunity for comment. We therefore grant the petition for review and vacate the new rule. As a consequence, the agency's previous practice of considering third-party human studies on a case-by-case basis, applying statutory requirements, the Common Rule, and high ethical standards as a guide, is reinstated and remains in effect unless and until it is replaced by a lawfully promulgated regulation.


EPA oversees a comprehensive scheme of pesticide regulation under FIFRA and FFDCA. While FIFRA governs pesticide registration, FFDCA regulates pesticide residues in the food supply. Originally enacted in 1947, FIFRA establishes a registration system allowing EPA to prescribe the conditions under which a pesticide may be sold or distributed. In determining whether to register a pesticide under FIFRA, EPA considers whether the pesticide would cause ''unreasonable adverse effects on the environment.'' 7 U.S.C.§ 136a(c)(5)(C). To determine whether the pesticide would cause such unreasonable environmental effects, the agency determines whether it would produce an ''unreasonable risk to man'' or any ''human dietary risk.'' 7 U.S.C. § 136(bb). Under FFDCA, EPA regulates the amount of pesticide that may remain on food products, establishing ''tolerance levels'' for pesticide residues on raw and processed food products. 21 U.S.C.§ 346a(b)(1).

The FFDCA provision dealing with the method of setting tolerances for pesticides was substantially revised by the Food Quality Protection Act of 1996, Pub. L. No. 104-170, 110 Stat. 1489 (''FQPA'').See 21 U.S.C. §346a (governing tolerances for pesticide chemical residues); see also Andrew J. Miller, Note, The Food Quality Protection Act of 1996: Science and Law at a Crossroads, 7 DUKE ENVTL. L. & POL'Y F. 393, 403 (1997) (''The FQPA rewrites most of section 408 of the FFDCA.''). The revised provision defines pesticide tolerances as ''safe'' when there is ''a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' 21 U.S.C. §346a(b)(2)(A)(ii). In determining whether pesticide tolerances are safe, EPA may consider the...

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