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October 30, 2000


The opinion of the court was delivered by: Huvelle, District Judge.



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 rulemaking 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 substances screening program pursuant to the FFDCA § 408(p); and (10) EPA has failed to provide adequate notice and opportunity to comment on the cancellation order for methyl parathion as required by FIFRA § 6(f)(1)(B).

In response, defendant EPA moved to dismiss the fourth amended complaint in its entirety on the grounds that (1) counts 2-5 fail to identify a statutory duty that has been "unlawfully withheld" or "unreasonably delayed" within the meaning of the APA, 5 U.S.C. § 706 (1); (2) counts 2-7 fail to meet the APA requirement of a "final agency action;" (3) counts 2-7 are not ripe; (4) plaintiffs have failed to exhaust administrative remedies with respect to counts 2-7; (5) plaintiffs lack standing to pursue counts 8 and 9; (6) count 10 is not ripe or fails to identify a case or controversy; and (7) this court lacks jurisdiction to hear counts 1, 2, 6, and 7, which belong in the Court of Appeals. NRDC filed a motion to intervene as a defendant in this case on October 27, 1999, which the court granted on February 7, 2000. NRDC has not moved to dismiss the fourth amended complaint in its entirety, but has only moved to dismiss counts 1-9. NRDC asserts that this court lacks jurisdiction to hear counts 1, 2, 6, and 7 because the Court of Appeals has exclusive jurisdiction over these counts.*fn1 NRDC further moves to dismiss counts 2-7 as not yet ripe for review and to dismiss counts 8 and 9 for lack of standing. In a separate motion, NRDC asks the court to sever and transfer counts 8 and 9 to the Ninth Circuit Court of Appeals or to the U.S. District Court for the Northern District of California.


In deciding a motion to dismiss, the court "must accept as true all well-pleaded factual allegations and draw all reasonable inferences in favor of the plaintiffs." Fitts v. Federal Nat'l Mortgage Ass'n, 44 F. Supp.2d 317, 321 (D.D.C. 1999). However, the court need not accept plaintiffs' legal conclusions as true. See Artis v. Greenspan, 158 F.3d 1301, 1306 (D.C.Cir. 1998). The court cannot address any issue if it lacks subject matter jurisdiction, and the case must be dismissed under Fed. R.Civ.P. 12(b)(1). Fitts, 44 F. Supp.2d at 320. Plaintiff bears the burden of proving subject matter jurisdiction by a preponderance of the evidence. If the court determines that "no relief could be granted under any set of facts that could be proved consistent with [plaintiffs'] allegations," the case must be dismissed under Fed. R.Civ.P. 12(b)(6) for failure to state a claim. Hishon v. King & Spalding, 467 U.S. 69, 73, 104 S.Ct. 2229, 81 L.Ed.2d 59 (1984).


Defendants argue that this court lacks jurisdiction to hear counts 1, 2, 6, and 7, and that those counts may only be heard in the court of appeals under the principles expressed in Telecommunications Research and Action Center v. FCC, 750 F.2d 70 (D.C.Cir. 1984) ("TRAC") and its progeny. TRAC held that where a statute commits review of final agency action to the court of appeals, the appellate court has exclusive jurisdiction to hear lawsuits alleging agency inaction where the relief sought might affect the court's future statutory power of review. Here defendants argue that counts 1, 2, 6, and 7 seek to compel the issuance of regulations "establishing general procedures and requirements to implement [FFDCA § 408]," as authorized by FFDCA § 408(e)(1)(c). Under the appellate review provision, FFDCA § 408(h)(1), challenges to the validity of regulations issued pursuant to FFDCA § 408(e)(1)(c) are reviewable by the circuit court only.

The court must address the issue of jurisdiction as a threshold matter, because absent jurisdiction the court lacks the authority to decide the case on any other grounds. See Ticor Title Ins. Co. v. FTC, 814 F.2d 731, 757 (D.C.Cir. 1987) (Green, J., concurring) (holding that "lower courts must always wrestle with [jurisdictional issues] before reaching any questions of justiciability, since courts may not decide issues over which they lack jurisdiction"); Tuck v. Pan American Health Organization, 668 F.2d 547, 549 (D.C.Cir. 1981) ("The federal courts are courts of limited jurisdiction, and they lack the power to presume the existence of jurisdiction in order to dispose of a case on any other grounds."); Jamison v. F.T.C., 628 F. Supp. 1548, 1550 (D.D.C. 1986) (holding that "TRAC" jurisdiction must be addressed first).

A. TRAC and its Progeny

In TRAC the D.C. Circuit held that where the Communications Act committed exclusive jurisdiction to review final FCC action to the court of appeals, a petition alleging unreasonable delay and seeking a writ of mandamus to compel FCC action was also subject to the exclusive jurisdiction of the court of appeals. 750 F.2d at 78-79. Federal courts are empowered under the All Writs Act, 28 U.S.C. § 1651 (a), to issue writs of mandamus necessary to protect their future jurisdiction. Because unreasonable agency delay could, as a practical matter, defeat appellate review of final agency orders, the TRAC court reasoned that the court of appeals had exclusive jurisdiction to hear suits seeking relief that might affect the circuit court's future jurisdiction, even where the agency had not issued a final order. Id. at 76. The court in TRAC determined that the district court lacked concurrent jurisdiction to hear the petition for mandamus based upon the well-established principle that where Congress by statute vests jurisdiction with a particular court, it cuts off original jurisdiction in other courts in all cases covered by the statute. Id. at 77.

Cases decided after TRAC have utilized a two-part test to determine whether jurisdiction to review agency action lies in the district court or in the court of appeals: (1) does the statute commit review of agency action to the court of appeals and (2) does the action seek relief that might affect the circuit court's jurisdiction? Jamison v. FTC, 628 F. Supp. at 1550 (holding that TRAC governed a request for injunction, in spite of constitutional claims, where the statute committed review of FTC action to the appellate court and future review was implicated). The second prong is broadly construed to favor appellate review. Id. However, where a statute contains no "single, overarching provision governing judicial review," but instead subjects "discrete agency actions" to specialized review provisions, actions taken under sections silent as to appellate review are "directly reviewable in a district court under some appropriate head of jurisdiction, for courts of appeals have only such jurisdiction as Congress has chosen to confer upon them." Cutler v. Hayes, 818 F.2d 879, 888 n. 61 (D.C.Cir. 1987) (holding that district court had jurisdiction to review alleged FDA inaction in the implementation of new drug regulations pursuant to FFDCA § 355 because no statutory provision committed direct review to the court of appeals); see also Nader v. U.S. EPA, 859 F.2d 747, 751 (9th Cir. 1988) (holding EPA's rejection of rulemaking petition to revoke pesticide tolerance was not an order appealable to the court of appeals under FFDCA § 346a or § 348 where, by their plain terms, those sections only allowed appellate review of orders issued under subsections not implicated in the litigation). In Cutler; the D.C. Circuit distinguished claims of agency inaction under the FFDCA, because, unlike the statute at issue in TRAC, the FFDCA only commits certain specific agency actions to appellate court review. 818 F.2d at 888 n. 61. Cutler held that a challenge to FDA regulation of new drugs under FFDCA § 355 and associated charges of agency inaction did not belong in the court of appeals, because the appellate review provision, § 355(h), applied only to cases challenging the disapproval of new drug applications. Id., citing Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 651, 93 S.Ct. 2488, 37 L.Ed.2d 235 (1973) (interpreting § 355(h) narrowly and endorsing district court jurisdiction to hear appeals from orders affecting new drug status). Likewise, in California v. Reilly, 750 F. Supp. 433 (E.D.Cal. 1990), the court held that limited appellate review provisions of the FFDCA did not divest the district court of subject matter jurisdiction under 28 U.S.C. § 1331 to hear statutory or constitutional challenges to EPA action. In Reilly defendants argued that 21 U.S.C. § 348 (g)(1), which provided for judicial review in the court of appeals for orders issued pursuant to 21 U.S.C. § 348 (f), set forth the entire permissible scope for judicial review of EPA action or inaction pertaining to § 409 of the FFDCA. Subsection 348(f) addressed the procedure for objections and public hearings of EPA orders. Plaintiffs contended that their facial challenge to the EPA's dual system of regulating carcinogenic pesticides did not fall within the limited review provision. The court agreed with plaintiffs and narrowly construed the appellate review provision of § 348(g)(1) as limited to the provision's plain language. The court declined to interpret a claim of EPA nonenforcement of the Delaney Clause as having been brought "pursuant to § 409(g)" because it "related to the process of setting tolerances." Id. at 436 ("The Supreme Court has held that a provision which refers expressly to review of `final orders,' as does § 409(g), does not encompass a claim under the Act simply because the claim is related to or may affect a `final order,' but applies only to those claims `literally' falling within the provision's scope.")

B. Counts 1, 2, 6, and 7

As noted, jurisdiction over a challenge to agency action or inaction lies in the district court unless the statute at issue specifically commits jurisdiction to the court of appeals. See Cutler, 818 F.2d at 887 n. 61 ("[C]ourts of appeals have only such jurisdiction as Congress has chosen to confer upon them."). Here, defendants contend that the FFDCA appellate review provision at 21 U.S.C. § 346a(h)(1) requires this court to transfer claims 1, 2, 6, and 7 to the court of appeals. Section 346a(h)(1) provides direct court of appeals review over three types of agency action:

(1) "actual controversy as to the validity of any regulation issued under subsection (e)(1)(C);"
(2) "any order issued under subsection (f)(1)(C) or (g)(2)(C);" and
(3) "any regulation that is the subject of such an order."

Defendants rely solely on subsection (e)(1)(C) as the basis for their TRAC argument. Subsection (e)(1)(C) provides that "[t]he Administrator may issue a regulation — establishing general procedures and requirements to implement [§ 346a]." Defendants assert that counts 1, 2, 6, and 7 "all seek to compel the issuance of regulations that are in the `general procedures' category," and thus, relief for counts 1, 2, 6, and 7 could only be issued ...

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