American Farm Bureau v. U.S. E.P.A.

• Decision Date: 30 October 2000
• Docket Number: No. CIV. 99-01405 ESH.,CIV. 99-01405 ESH.
• Citation: 121 F.Supp.2d 84
• Parties: AMERICAN FARM BUREAU, et. al., Plaintiffs, v. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, et. al., Defendants.
• Court: U.S. District Court — District of Columbia

121 F.Supp.2d 84

AMERICAN FARM BUREAU, et. al., Plaintiffs, v. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, et. al., Defendants.

No. CIV. 99-01405 ESH.

United States District Court, District of Columbia.

October 30, 2000.

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Kenneth W. Weinstein, Jeffrey R. Holmstead, Latham & Watkins, Washington, DC, Edward S. Lee, Peter C. Choharis, Mayer, Brown & Platt, New York, NY, John Joseph Sullivan, Mayer, Brown & Platt, Washington, DC, for Plaintiffs.

Brian H. Lynk, U.S. Department of Justice, Environmental Defense Section, Washington, DC, for Defendants.

Erik D. Olson, Natural Resources Defense Council, Washington, DC, for Intervenor-Defendant Natural Resources Defense Council.

MEMORANDUM OPINION

HUVELLE, District Judge.

This case comes before the court on a motion to dismiss the fourth amended complaint filed by defendant United States Environmental Protection Agency (EPA) and on motions to dismiss counts one through nine and/or to sever and transfer counts eight and nine filed by intervener defendant Natural Resources Defense Council (NRDC). In addition, defendant EPA has moved for a protective order. Plaintiffs seek declaratory and injunctive relief to compel the EPA to take certain actions that plaintiffs claim are statutorily mandated, including the promulgation of regulations and guidelines and the implementation of procedures to collect scientific data for the evaluation of pesticide safety, and to preclude the EPA from applying other policies which plaintiffs allege are unlawful.

BACKGROUND

Plaintiffs, twenty-five organizations representing farmers and other producers of food crops, manufacturers and suppliers of crop protection and enhancement products, and manufacturers and users of pesticides and other chemicals, challenge the EPA's implementation of the Food Quality Protection Act of 1996 (FQPA), Pub.L. No. 104-170. The FQPA amended both the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. §§ 301-394, and the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. §§ 136-136y, by requiring the EPA to evaluate new pesticide uses and reevaluate the safety of authorized pesticide uses based upon a complex measurement of risk factors. FFDCA § 408(b)(2)(A)(ii), 21 U.S.C. § 346a(b)(2)(A)(ii).

The EPA regulates pesticides under both the FFDCA and FIFRA. FIFRA imposes a federal licensing scheme on the sale, distribution, and use of pesticides. It provides that "no person in any State may distribute or sell to any person any pesticide that is not registered" by the EPA. 7 U.S.C. § 136a(a). A pesticide cannot be registered unless EPA, after substantial testing, determines that "it will not generally cause unreasonable adverse effects in the environment." 7 U.S.C. § 136a(c)(5)(D). The process for registering a pesticide is described in FIFRA and EPA regulations at 7 U.S.C. § 136a and 40 C.F.R. §§ 152 and 158. Under certain "emergency" conditions, however, the EPA may exempt a pesticide use from the FIFRA registration requirement. 7 U.S.C. § 136p. FIFRA further provides that if the EPA later determines that additional scientific data are required to maintain in effect an existing pesticide registration, the EPA must notify all registrants of the pesticide in what is termed a "data call-in" to provide registrants with the opportunity to submit the additional data specified in the notice or face suspension of their registration. 7 U.S.C. § 136a(c)(2)(B)(ii). Under 1988 amendments to FIFRA, the EPA is required to re-register any pesticide first registered before November 1, 1984. 7 U.S.C. § 136a-1(a)-(g). For those pesticides that the EPA re-registers, EPA must determine whether additional "product-specific data" is needed, and if so, obtain that information through a data call-in. 7 U.S.C. § 136a(g)(2)(A) and (B). Upon review of the product-specific data, the EPA must decide if the particular product warrants re-registration. 7 U.S.C. § 136a-1(g)(2)(C).

The FFDCA provides for the regulation of the presence of pesticides in agricultural commodities by empowering the EPA to establish "tolerances" setting the maximum allowable levels of pesticide residue in foods. 21 U.S.C. § 346a(b)(1). Before any agricultural commodity containing pesticide residue can be sold or distributed, a tolerance that meets statutory safety standards must be adopted by the EPA for that pesticide. Where a pesticide is used on more than one food crop, a separate tolerance for the pesticide must be established for each crop. Foods containing pesticide residues for which no tolerance has been set or containing a pesticide residue level greater than the tolerance established by the EPA are considered "unsafe" and "adulterated" and may not legally be moved in interstate commerce. 21 U.S.C. §§ 331(a), 342(a)(2)(B), 346a(a). However, the EPA may establish an exemption from the tolerance for a pesticide chemical residue in or on food if the agency determines that it is safe, i.e., that "there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposure and all other exposure for which there is reliable information." 21 U.S.C. §§ 346a(c)(1)-(2). Tolerances and exemptions are established, modified, and revoked both upon the EPA's own initiative and in response to petitions from the public, as described at 21 U.S.C. § 346a(d)(2) and 40 C.F.R. § 180.7. If, after a tolerance is established, the EPA "determines that additional data or information are reasonably required to support the continuation of a tolerance or exemption ... the [agency] shall — (A) issue notice requiring the person holding the pesticide registrations associated with such tolerance or exemption to submit the data or information under section 3(c)(2)(B) of [FIFRA] ...; (B) issue a rule requiring that testing be conducted on a substance or mixture under section 4 of the Toxic Substances Control Act ...; or (C) publish in the Federal Register, after first providing notice and an opportunity for comment of not less than 60 days duration, an order" announcing a data call-in and specifying the type of information that must be submitted to the agency. 21 U.S.C. § 346a(f)(1).

The FQPA significantly amended both FIFRA and the FFDCA by increasing the number of factors that the EPA must consider in establishing a tolerance or exemption, including "aggregate exposure to the pesticide chemical residue" from "all anticipated dietary exposures and all other exposures for which there is reliable information" and the cumulative effects of substances that have a "common mechanism of toxicity." 21 U.S.C. § 346(b)(2)(A)(ii). Furthermore, EPA must use "an additional tenfold margin of safety" when applying the standard to children and infants. 21 U.S.C. § 346a(b)(2)(C)(ii)(II). The FQPA amendments also require the EPA to reassess the more than 9,000 pesticide tolerances and exemptions in existence at the time the amendments were enacted to determine whether those tolerances meet the more stringent FQPA safety standards. 21 U.S.C. § 346a(q). The FFDCA, as amended, provides the following three-tiered schedule for the reassessment of existing tolerances and exemptions: (1) 33% within three years of August 3, 1996, (2) 66% within six years of August 3, 1996, and (3) 100% within ten years of August 3, 1996. 21 U.S.C. § 346a(q)(1). EPA is to give priority in the reassessment process to those tolerances and exemptions that "appear to pose the greatest risk to public health." 21 U.S.C. § 346a(q)(2). These reassessments are conducted in conjunction with EPA's existing obligation under FIFRA to re-register all pesticides registered before November 1, 1984. The FFDCA, as amended, also requires the EPA to issue tolerances for pesticide uses exempted under the § 18 emergency provision of FIFRA. 21 U.S.C. § 1346a(l)(6), 7 U.S.C. § 136p. EPA is directed to promulgate regulations governing the establishment of tolerances for § 18 exemptions within 365 days of the enactment of the FQPA. Id. Finally, the FQPA amendments called for the EPA to implement an endocrine disruptor screening program within three years after August 3, 1996, to determine "whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as [EPA] may designate." 21 U.S.C. § 346a(p)(1).

Plaintiffs filed suit on June 2, 1999, and have since amended the complaint four times. The Fourth Amended Complaint alleges that (1) EPA has failed to promulgate regulations setting tolerances for emergency exemptions under FIFRA § 18, in violation of its statutory duty under § 408(1)(6) of the FFDCA; (2) EPA has failed to promulgate data requirements for the establishment and continuation of tolerances, as required under the FFDCA § 408(d)(2)(A); (3) EPA has failed to update the data requirements for registration of a pesticide, as required under FIFRA § 3(c)(2)(A); (4) EPA has failed to implement the FFDCA § 408(f)(1) by not collecting the data needed to complete tolerance reassessments; (5) EPA has failed to comply with the data collection requirements of FIFRA § 3(c)(2)(A) and § 3(c)(2)(B); (6) EPA has adopted a policy using the 99.9th percentile of acute dietary exposure as the regulatory threshold for determining whether a tolerance satisfies statutory safety standards in a manner that has the force and effect of law, without following the rule-making requirements of § 553(b) of the Administrative Procedures Act (APA); (7) EPA has implemented an FQPA infant and child safety factor policy in a manner that has a binding and future effect for the regulated industry, without following the rule-making requirements of APA § 553(b); (8) EPA has not met its published three-part tolerance reassessment schedule under the FFDCA § 408(q)(3); (9) EPA has failed to develop and implement an estrogenic...