Croplife America v. E.P.A., 02-1057.

• Decision Date: 03 June 2003
• Docket Number: No. 02-1057.,02-1057.
• Parties: CROPLIFE AMERICA, et al., Petitioners, v. ENVIRONMENTAL PROTECTION AGENCY, Respondent. Natural Resources Defense Council and American Chemistry Council, Intervenors.
• Court: U.S. Court of Appeals — District of Columbia Circuit

329 F.3d 876

CROPLIFE AMERICA, et al., Petitioners, v. ENVIRONMENTAL PROTECTION AGENCY, Respondent Natural Resources Defense Council and American Chemistry Council, Intervenors.

No. 02-1057.

United States Court of Appeals, District of Columbia Circuit.

Argued March 17, 2003.

Decided June 3, 2003.

COPYRIGHT MATERIAL OMITTED

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 Judge.

Opinion for the Court filed by Circuit Judge HARRY T. EDWARDS.

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 21 U.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 7 U.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 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.

I. BACKGROUND

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 validity of the available data from studies, anticipated and actual residue levels of the pesticide in or on foods, the percent of food actually treated with the pesticide, and international standards. See 21 U.S.C. § 346a(b)(2)(D)-(F), (b)(4).

In 1988, Congress amended FIFRA to require that every pesticide registered before 1984 be reregistered under present-day standards. Pub.L. No. 100-532, 102 Stat. 2654 (codified as amended in scattered sections of 7 U.S.C.). In 1996, Congress also set deadlines for EPA to review all existing tolerances against the new standard established by the FQPA. 21 U.S.C. § 346a(q). As a result, the agency is currently in the process of reexamining thousands of regulated pesticides. This process involves years of preliminary action and evaluation under both FIFRA and FFDCA, culminating in public pronouncements of the agency's position on the safety of a given pesticide.

For decades, EPA accepted and relied upon third-party human data in evaluating pesticide safety. However, the agency's position shifted in 1998. On July 27, 1998, EPA stated publicly that it would ask an internal review board to reevaluate the agency's use of third-party human studies. EPA Statement, July 27, 1998, App. 11. EPA's statement also indicated that "[n]o human test data has been used by EPA for any final decisions about acceptable levels of pesticide use under the [1996 FQPA]." Id. An October 1998 internal EPA memorandum amplified this statement, indicating that EPA's policy was to consider only third-party human data that meets "the highest ethical standards." Memorandum from Peter D. Robertson, Acting Deputy Administrator, EPA, to EPA Assistant Administrators 3 (Oct. 9, 1998), App. 14. Although the July 1998 statement signaled the beginning of EPA's reconsideration of the role of human testing, the agency's Office of Pesticide Programs continued to review human test data and to discuss the results of such reviews in the public record of regulatory decisions. See OFFICE OF PESTICIDE PROGRAMS, ENVTL. PROT. AGENCY, ROLE OF HUMAN STUDIES IN THE OFFICE OF PESTICIDE PROGRAMS 3 (2001), App. 118.

As part of its policy development process, EPA appointed a Joint Subcommittee of its Science Advisory Board and FIFRA Scientific Advisory Panel ("the Joint Subcommittee") to evaluate the circumstances under which third-party human data should be considered. In September 2000, the Joint Subcommittee issued a report addressing the ethical and scientific acceptability of utilizing such data. The report "envision[ed] particular circumstances under which such dosing of humans could be scientifically and ethically acceptable," but found such circumstances "very difficult" to define. ENVTL. PROT. AGENCY, COMMENTS ON THE USE OF DATA FROM THE TESTING OF HUMAN SUBJECTS: A REPORT BY THE SCIENCE ADVISORY BOARD AND THE FIFRA SCIENTIFIC ADVISORY PANEL 2 (2000), App. 34. Sixteen panel members recommended that the agency continue to consider human studies under strict standards, while two members advocated a blanket ban on such tests. Id. at 1-4, App. 33-36.

Thereafter, in October 2001, EPA made clear that it would consider data from third-party human studies on a case-by-case basis. See John Heilprin, EPA Using Human Testing Data from Manufacturers in Evaluating Pesticide Regulations, Exposure Levels, ASSOCIATED PRESS, Nov. 27, 2001, LEXIS, News Library, News Group File; Shogren, supra; Shankar Vedantam, EPA Used Data from Human Pesticide Tests, WASH. POST, Nov. 29, 2001, at A6. In several pesticide regulatory decisions issued around the time of the announcement, EPA in fact considered available human data. See, e.g., Interim Reregistration Eligibility Decision for AzinphosMethyl, Case No. 0235, at 10-11 (EPA Oct. 30, 2001), App. 88-89; Interim Reregistration Eligibility Decision for Phosmet, Case No. 0242, at 8 (EPA Oct. 30, 2001), App. 92; Interim Reregistration Eligibility Decision for...