No. C 99-03701 WHAUnited States District Court, N.D. California.
September 24, 2001
ORDER APPROVING PROPOSED CONSENT DECREE; DISMISSING COUNT SIX OF COMPLAINT BROUGHT BY NRDC ET AL.; DISMISSING COMPLAINT BROUGHT BY AFBF ET AL.
WILLIAM ALSUP, United States District Judge.
INTRODUCTION
Farm workers, environmentalists, and cancer-related groups brought this action against the Environmental Protection Agency, challenging EPA’s allegedly inadequate regulation of pesticides. Subsequently, organizations representing pesticide manufacturers, agricultural interests, and animal rights intervened as plaintiffs. EPA and the original plaintiffs have now proposed a settlement, the subject of this order. The proposed settlement has three components: a consent decree binding EPA to a timetable for promulgating pesticide regulations, voluntary dismissal of a petition for review now pending in the Ninth Circuit, and voluntary dismissal of one cause of action herein, subject to a private proposed settlement agreement. The intervenor-plaintiffs object to the settlement on the grounds that it will harm their interests. This order holds that the proposed settlement is fair, equitable, reasonable, legal, and in the public interest. Accordingly, the proposed consent decree is APPROVED, and count six of complaint herein brought by the Natural Resources Defense Council et al. is DISMISSED. All the causes of action brought by plaintiffs-in-intervention the American Farm Bureau Federation et al. are DISMISSED as moot. The complaint brought by plaintiffs-in-intervention People for the Ethical Treatment of Animals et al. is all that remains of this action.
STATEMENT
In 1996, Congress passed the Food Quality Protection Act.[1] FQPA amended the statutory regimes by which EPA was (and is) tasked with regulating pesticides: the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301-394, and the Federal Insecticide, Fungicide and Rodenticide Act, 7 U.S.C. § 136-136y. FFDCA required EPA to set allowable levels of pesticide residues in foods, called tolerances. Under FIFRA, EPA licensed pesticides and could prohibit the use of a pesticide if it would have an “unreasonable adverse effect on the environment.” FQPA altered FFDCA in four ways significant to this litigation. First, it set a more stringent standard for pesticide exposure than previously existed. Second, it set a series of deadlines by which EPA was required reassess the tolerances and exemptions to tolerances for 9,728 pesticide uses: 33% by August 3, 1999, 66% by August 3, 2002, and 100% by August 3, 2006. Third, it required EPA to coordinate reassessments under FFDCA with a similar re-registration scheme under FIFRA. Fourth, it required EPA to propose for public review by August 3, 1998, an “endocrine disruptor screening program” to study whether any pesticides have an estrogenic effect on the human endocrine system and to implement the program by August 3, 1999.
FQPA further required EPA to publish by August 3, 1997, a schedule for accomplishing tolerance reassessments. 21 U.S.C. § 346a(q)(3). While FQPA gave EPA unreviewable discretion in determining the sequence in which pesticides would be evaluated, it required EPA to adhere to the schedule once it was set. Ibid. The schedule subsequently published by EPA required it to assess (i) 3,210 tolerances or exemptions by August 3, 1999, (ii) 6,420 tolerances or exemptions by August 3, 2002, and (iii) 9,728 tolerances or exemptions by August 3, 2006. 62 Fed. Reg. 42,019-22 (Aug. 4, 1997). The schedule divided pesticides into three groups. Group 1 was comprised of more than 5,000 pesticide uses that, according to EPA, “appear to pose the greatest risk to public health.” Id. at 42021. According to the schedule: “In general, tolerances and exemptions from Group 1 pesticides will be subject to reassessment first.” Ibid.
The Parties
On August 3, 1999, plaintiffs the Natural Resources Defense Council, the Breast Cancer Fund, CalPIRG Charitable Trust, Pesticide Watch Education Fund, Pesticide Action Network North American Regional Center, San Francisco Bay Area Physicians for Social Responsibility, and United Farm Workers of America, AFL-CIO (collectively “settling plaintiffs”), filed this action alleging that EPA had failed to meet the tolerance-reassessment deadlines set by FQPA. Simultaneously, settling plaintiffs filed a petition for review in the Ninth Circuit seeking to compel re-registration of pesticides under FIFRA, which provided that certain decisions made under that act are reviewed directly by a court of appeals. Settling plaintiffs subsequently amended their complaint to allege that (i) EPA had failed to timely reassess the safety of organophosphates, (ii) had reassessed chemicals of lesser priority first, contrary to the schedule EPA had published, (iii) had failed to reassess the proper number of pesticides by August 3 as required by FQPA and EPA’s published schedule, and (iv) had failed to meet the statutory deadline for implementing an endocrine-disruptor screening program. Settling plaintiffs sought, inter alia, an injunction requiring EPA to comply with a court-ordered schedule for the reassessment of organophosphates and other pesticides and for the establishment of an endocrine-disruptor screening program.
The American Farm Bureau Federation, the American Crop Protection Association, and the American Chemistry Council (collectively “objecting plaintiffs”) moved to intervene as plaintiffs on November 1, 1999. Their motion was granted on December 8, 1999. In their complaint, objecting plaintiffs alleged that EPA’s failure to timely reassess the use of pesticides created “great uncertainty and hinder[ed] their ability to make the necessary planning and investments to ensure that their crop protection products satisfy EPA’s reassessment standards” (AFBF Compl. ¶ 29). They sought a “permanent injunction specifying that EPA must establish and adhere to a tolerance reassessment schedule that satisfies all of the Agency’s responsibilities under FQPA relating to tolerance reassessment” (id. ¶ 31). Substantially similar claims were made by AFBF in an action it had filed against EPA in the District of Columbia on June 2, 1999. See Am. Farm Bureau v. United States Envtl. Protection Agency, 121 F. Supp.2d 84 (D.D.C. 2000).[2] Objecting plaintiffs intervened in the Ninth Circuit action as well.
On February 24, 2000, People for the Ethical Treatment of Animals, Physicians’ Committee for Responsible Medicine, and the Doris Day Animal League (collectively “animal-rights plaintiffs”) moved to intervene as plaintiffs. Their motion was granted on April 19, 2000. Their complaint was entirely directed to the endocrine-disruptor screening program. According to animal-rights plaintiffs, EPA had (i) failed to adopt a screening program as required by FQPA and (ii) had failed to appropriately validate tests to be used in the endocrine-disruptor screening program, because it had arbitrarily subjected tests that did not involve the use of laboratory animals to a more rigorous validation process than was used for tests that involved animals. They sought a “permanent injunction ordering the EPA to expeditiously validate and implement the non-animal in vitro assays and high throughput screens necessary to comply with the FQPA” (PETA Compl. at 11).
The Settlement
Throughout the pendency of this litigation, settling plaintiffs and EPA were engaged in settlement discussions through the Ninth Circuit’s mediation program. As a result, briefing in the Ninth Circuit case was stayed. On January 12, 2001, EPA and settling plaintiffs finalized a draft of a proposed settlement and provided it to the intervening parties for their comments. The proposed settlement had three components. The first was that EPA would be bound by a consent decree setting a schedule for making regulatory determinations under FFDCA and FIFRA. The second was that settling plaintiffs would dismiss their cause of action regarding the endocrine-disruptor screening program and their petition for review in the Ninth Circuit. And the third was that EPA would enter into a private settlement agreement that it would make its best efforts to implement an endocrine-disruptor screening program that had been proposed by an advisory committee formed by EPA, EDSTAC (Endocrine Disruptor Screening and Testing Advisory Committee). The intervenors were told that the settlement would be filed on January 19, but that they could continue to submit comments that would be considered during the approval process (Weinstein Decl., dated Feb. 16, Exh. 2, at 2-3). By January 19, the intervenors had only made general comments about the proposed consent decree, but had given more specific comments regarding the proposed private non-decree settlement agreement regarding the endocrine-disruptor screening program. These comments, the settling parties state, were incorporated into the proposed private settlement agreement (Olson Decl. ¶ 14; Weinstein Decl., dated Feb. 16, Exh. 2). On January 19, settling plaintiffs and EPA filed the proposed consent decree and the proposed private settlement agreement herein.
Objecting plaintiffs then filed an amended complaint on February 16 and then their first amended complaint on February 20, which alleges that: (i) the Court lacks jurisdiction over the portions of the proposed consent decree related to FIFRA; (ii) the proposed consent decree violates FFDCA and FIFRA because it precludes EPA from considering relevant information; and (iii) the proposed consent decree is arbitrary and capricious in violation of the Administrative Procedure Act, 5 U.S.C. § 553 et seq.[3]
On March 13, objecting plaintiffs submitted comments on the proposed consent decree to the settling parties. According to the settling parties, these comments resulted in significant changes to the proposed consent decree (Olson Decl. ¶ 18). Animal-rights plaintiffs submitted comments on March 15, which were considered as well (id. ¶ 20). On March 19, Christine Todd Whitman, the newly-appointed head of EPA, issued a directive to the agency. It read (Joint Notice of Filing, dated Mar. 21, 2001, Exh. A, at 1):
EPA staff has met with the Department of Agriculture, industry, agricultural, and animal rights interveners in the NRDC v. Whitman litigation, NRDC, and others to discuss the best way of implementing the Agency’s obligations under the Consent Decree. This Directive is in response to a number of concerns raised at those meetings. The Agency also negotiated modifications to the Consent Decree to address some of these concerns. It is my goal for the Agency to conduct preregistration and reassessment activities in an open and transparent manner, with ample opportunities for public participation, and to make all regulatory decisions based upon principles of sound science. It is my belief that the Consent Decree is consistent with these goals, and I want to assure that the Consent Decree be implemented with these goals in mind. To that end, I am hereby directing the Office of Prevention, Pesticides, and Toxic Substances to do all the following . . .
The directive set forth fifteen separate procedures for EPA to follow in implementing the proposed consent decree as modified after discussions with the parties. The procedures were designed to allow public participation in the scientific determinations for which the proposed consent decree set deadlines: for example, holding a public meeting where interested parties could comment on EPA’s analysis of relative-potency factors, soliciting public comment on “common mechanism” determinations, and publishing toxicity studies being relied on for preliminary risk assessments (id. at 2-3). On March 22, settling plaintiffs and EPA submitted a revised proposed consent decree, almost identical to the one they now seek to have approved.
By order dated April 13, 2001, EPA was required to publish the terms of the proposed consent decree and its reasons for entering into it on its website and to allow public comment on the terms. In light of these comments, the issues were rebriefed. The hearing date on approval of the settlement was postponed, however. In the interim, the case was re-assigned to the undersigned.
On August 31, 2001, the settling parties submitted an amended proposed consent decree, since EPA had completed certain activities required under previously-proposed consent decree. Additionally, the amended proposed consent decree extended two deadlines to allow EPA time to consider recently-received studies. It is this amended proposed consent decree that the parties now seek to have approved.
The Eleventh-Hour Supplemental Declaration
Shortly before the September 6 hearing on the approval of the proposed consent decree, objecting plaintiffs submitted the supplemental declaration of three declarants: Chris Wilkinson, Micheal Genevan, and Robert Sielken. The declaration responded to a relative-potency study published by EPA on July 31, 2001. As will be explained, this study was a preliminary step in conducting one of the scientific determinations required by the proposed consent decree, the preliminary cumulative-risk assessment for organophosphates. According to the declaration, the study revealed that there were fundamental flaws in EPA’s methodology, which would render compliance with the deadline in the consent decree, December 1, 2001, impossible. At the hearing on September 6, it was stated that EPA’s methodology for the relative-potency study was currently under review by the Scientific Advisory Panel (“SAP”), an independent peer-review group that oversees EPA’s determinations under FIFRA. At the hearing, objecting plaintiffs argued that the SAP would not endorse EPA’s methodology. Since review and decision by SAP was imminent, the Court declined to rule on the proposed consent decree so that it could consider the results of the SAP review and allow further briefing. SAP’s report was submitted by EPA on September 14. As EPA predicted at the hearing, the report revealed no serious flaws in EPA’s methodology.
Statutory Framework 1. The Federal Food, Drug, and Cosmetics Act
As stated, the FFDCA required the EPA to establish “tolerances” for every pesticide. A tolerance was the maximum allowable level of pesticide residue in a given food. 21 U.S.C. § 346a(b)(1). In other words, a pesticide used on different foods had a separate tolerance for each food. On its own initiative or in response to petitions from the public, EPA was allowed to establish an exemption from a tolerance, if the statutory safety standard had been met. 21 U.S.C. § 346a(c)(1)-(2). Foods containing pesticide residues for which no tolerance had been set or containing a pesticide-residue level exceeding the tolerance established by EPA could not be sold. 21 U.S.C. § 331(a), 342(a)(2)(B), 346a(a). When EPA set a final tolerance, the tolerance was published, and anyone could file an objection to the tolerance and request an administrative hearing on the merits of the objection, which was subject to judicial review. 21 U.S.C. § 346a(g)(2).
Before 1996, EPA was required to set tolerances that were “safe for use, to the extent necessary to protect the public health” in consideration of a number of factors, and to allow exemptions “when such a tolerance is not necessary to protect the public health.”21 U.S.C. § 346a(b), (d) (1995). FQPA changed this standard by defining “safe” as “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. § 346(b)(2)(A)(ii). Overall, FQPA required EPA to consider the following factors that EPA was not previously required to assess: the cumulative effects of substances sharing a “common mechanism of toxicity,” the effect of “aggregate exposures” (exposures through water and residential uses as opposed to merely food), and the possible increased susceptibility of infants and children. 21 U.S.C. § 346a(b)(2).
In addition, because the FQPA amendments implemented a more stringent standard, FQPA required EPA “as expeditiously as practicable” to “review” 9,728 pesticide tolerances and exemptions that were in existence at the time the amendments were enacted to determine whether they satisfied the new standards. 21 U.S.C. § 346a(q). It stated: “In conducting a review of a tolerance or exemption, the Administrator shall determine whether the tolerance or exemption meets the requirements of subsections (b)(2) or (c)(2) of this section and shall, by the deadline for the review of the tolerance or exemption, issue a regulation under subsection (d)(4) or (e)(1) of this section to modify or revoke the tolerance or exemption if the tolerance or exemption does not meet such requirements.” Ibid. This review process was known as reassessment.
As stated, FQPA provided the following schedule for the reassessment: (i) 33% within three years of August 3, 1996, (ii) 66% within six years of August 3, 1996, and (iii) 100% within ten years of August 3, 1996. 21 U.S.C. § 346a(q)(1). EPA was required 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). It was also required to “the extent practicable and consistent with the review deadlines” established by FQPA, to coordinate any revocation of a tolerance or exemption with “any related necessary action under the Federal Insecticide, Fungicide, and Rodenticide Act.”21 U.S.C. § 346a(l)(1).
2. The Federal Insecticide, Fungicide, and Rodenticide Act
FIFRA prohibited the sale, distribution, or use of a pesticide not registered with EPA. 7 U.S.C. § 136a(a). A pesticide could be registered if EPA determined that it would “not generally cause unreasonable adverse effects in the environment.”7 U.S.C. § 136a(c)(5)(D). “Unreasonable adverse effects in the environment” was defined to include “a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under Section 346a of Title 21 [FFDCA].”7 U.S.C. § 136(bb). Under certain “emergency” conditions, EPA could exempt a pesticide from the registration requirement. 7 U.S.C. § 136p.
Under the 1988 amendments to FIFRA, EPA was required to re-register any pesticide first registered before November 1, 1984, giving priority to those: (i) used in food, (ii) raising concerns about contamination of potable groundwater or edible sea life, (iii) having outstanding data requirements, and (iv) used on crops where worker exposure was most likely to occur. 7 U.S.C. § 136a-1(c). The re-registration process occurred in phases, beginning with data gathering and submission by interested parties. In one of the preliminary steps, EPA announced the eligibility of a pesticide for re-registration in a RED (Reregistration Eligibility Decision). A RED contained information such as the active ingredient, the toxicity data, the avenues of exposure, the list of data considered by EPA, and EPA’s conclusion. If EPA determined that a pesticide was ineligible for re-registration, it provided a draft notice of cancellation to SAP, the independent group of scientists that reviewed EPA’s scientific decisions, and to the United States Department of Agriculture. 7 U.S.C. § 136d(b). While there was no deadline for issuing a draft notice of cancellation, 60 days after issuing one, EPA could issue a notice of cancellation. Ibid. At that time, any aggrieved person could request an administrative hearing on whether the registration should be canceled. Ibid. Cancellation of the registration was stayed during the pendency of the hearing. Ibid.
By the time FQPA was enacted in 1996, the FIFRA re-registration process was far from completed. As part of the FQPA amendments to FIFRA, Congress explicitly required EPA to coordinate pesticide registration under FIFRA with the reassessment of tolerances under FFDCA. Specifically, FIFRA provided that no later than the time EPA re-registered a pesticide, EPA “shall reassess each associated tolerance and exemption from the requirement for a tolerance issued under Section 408 of the Federal Food, Drug, and Cosmetics Act (21 U.S.C. § 346a); determine whether such tolerance or exemption meets the requirements of that Act (21 U.S.C.A. 301 et seq.); [and] determine whether additional tolerances or exemptions should be issued.” 7 U.S.C. § 136a-1(g)(2)(E)(i)-(iii).
3. EPA’s Implementation of FIFRA and FFDCA
EPA implemented pesticide re-registrations under FIFRA and tolerance reassessments under FFDCA through its Office of Pesticide Programs, which coordinated these efforts by issuing tolerance reassessments under FFDCA as part of a RED under FIFRA. In conjunction with EPA’s duties under FIFRA and FFDCA, the Office of Pesticide Programs also developed several non-statutory procedures to enhance stakeholder participation in the regulatory process. For example, for organophosphates, one of the main groups of chemicals at issue in this action, the non-statutory procedures and the determinations required by FIFRA and FFDCA were all performed together in sequence set forth below.
First, EPA would issue a preliminary risk assessment on an individual chemical. This study included both the human health risk evaluation needed for tolerance reassessment under FFDCA, and the ecological risk assessment necessary for FIFRA re-registration. This was followed by public comment, then a revised risk assessment, and then additional public comment. In some cases, EPA then issued a RED, which contained all the risk management information, EPA’s conclusions, and the risk reduction measures necessary for re-registration. If, however, EPA determined that the pesticide shared a common mechanism of toxicity with other pesticides and thus may have had a cumulative toxic effect, it performed both a preliminary and final cumulative-risk assessment (with public comment in between and after), before issuing a RED. Before a cumulative-risk assessment could be done, individual risk assessments had to be performed for each related chemical. If EPA was unable to issue a RED because a cumulative-risk assessment was necessary, it would publish an interim RED, which was a complete RED, minus cumulative-risk-assessment data. In issuing a RED, EPA could issue a final tolerance reassessment. If, however, EPA determined that a tolerance needed revocation or adjustment, EPA issued a final rule, subject to notice and comment. If EPA found that a pesticide was ineligible for re-registration, it issued a notice of intent to cancel the registration and then a notice of cancellation. Only a final tolerance reassessment and notice of cancellation were subject to administrative adjudication and judicial review.
The Proposed Consent Decree
The proposed consent decree requires EPA to complete REDs for four pesticides and interim REDs for six pesticides by specific deadlines.[4]
It sets December 1, 2001, as the deadline for EPA to issue a preliminary risk assessment of the cumulative effects of 39 organophosphate pesticides (Proposed Consent Decree ¶ 4). After 240 days of public comment, the final cumulative-risk assessment will be due (ibid.). It sets deadlines for EPA to determine whether two groups of pesticides share common mechanisms of toxicity (id. ¶ 10).[5] It requires EPA to determine whether three pesticides pose risks to workers that constitute unreasonable adverse effects on the environment, and sets an eight-month deadline for EPA to send a notice of cancellation to SAP and USDA for these pesticides, if EPA finds that this is required (id. ¶ 9).[6] It also requires EPA to publish annual reports providing updates on actions EPA has taken and plans to take pursuant to the proposed consent decree (id. ¶ 11).
The proposed consent decree explicitly reserves settling plaintiffs’ right to challenge any final agency action, and EPA’s defenses to such a challenge (id. ¶¶ 9b, 10, 15). It contains clauses that provide that the consent decree does not require EPA to take any actions that are contrary to the law (id. ¶¶ 18-19), provisions that allow non-compliance with certain deadlines if EPA determines that its premises or methodology are “significantly flawed” (id. ¶ 5), and sections that allow EPA to delay certain decisions if it is provided with new scientific information (id. ¶ 9d). Two provisions explicitly preserve agency discretion (id. ¶¶ 17-18):
Except as provided herein, nothing in this Consent Decree shall be construed to limit or modify the discretion accorded to the EPA by the FFDCA, FIFRA, the APA, or general principles of administrative law.
Nothing in this Consent Decree shall bar EPA from acting on any matters covered in this Consent Decree in a time frame earlier than required by this Consent Decree or to take additional actions not specified herein if EPA determines such action are appropriate under applicable law.
It also contains a dispute-resolution provision, which requires the parties to meet and confer before seeking judicial enforcement (id. ¶ 24).
ANALYSIS
As a general matter, “a district court should enter a proposed consent judgment if the court decides that it is fair, reasonable, and equitable and does not violate the law or public policy.” Sierra Club, Inc. v. Electronic Controls Design, Inc., 909 F.2d 1350, 1355 (9th Cir. 1990). As this Court has recently noted, however, when a government agency is the target of a consent decree, additional concerns about the decree’s effects on the agency’s long-term ability to exercise its judgment and expertise are raised. See Center for Biological Diversity v. Bureau of Land Management, No. C 00-00927 WHA, 2001 WL 777088, at *4-5 (N.D.Cal. March 20, 2001). In such circumstances, a court must examine how long a proposed consent decree would tie the agency’s hands in future matters.
Agency Discretion
This order finds that the proposed consent decree does not unduly tie the hands of the agency. It does not dictate any substantive results, or otherwise prevent EPA from exercising its scientific judgment. The decree has safety valves that would allow EPA to avoid deadlines if EPA determines that it is required to consider new data or that its methodology is flawed. Specifically, it states, for instance, that EPA shall be excused from the deadlines regarding the risk assessment for organophosphates if EPA finds that “(1) the premises underlying EPA’s risk assessment of Organophosphate Pesticides are significantly flawed or (2) the methodology for conducting the risk assessment is significantly flawed” (Proposed Consent Decree ¶ 5). Moreover, it contains two express provisions preserving EPA’s discretion regarding everything but the deadlines in the proposed consent decree.
The proposed consent decree further upholds all avenues of public notice and comment and EPA’s ability to respond to public concerns. It provides that the proposed consent decree does not authorize “any action in contravention of the FFDCA, FIFRA, the APA, or any other law or regulation, either substantive or procedural” (id. ¶ 19). And it states, “Nothing in this Consent Decree alters or affects the standards for judicial review of final EPA action, or creates jurisdiction that would otherwise not exist to review EPA action” (id. ¶ 15). Since REDs are a preliminary step in final rulemaking, after a final rule has been issued, any affected person or entity can bring an administrative challenge to the final rule, at which time implementation of the rule would be stayed. The consent decree sets no deadlines for the promulgation of any final rule, thus allowing EPA to consider all information required by law.
Finally, the proposed consent decree has a short duration. All but two activities required by the proposed consent decree must be completed by August 2002. The only dates outside that window are the deadline for the interim RED for carbaryl (June 30, 2003) and the deadline for the revised risk assessment for metam sodium (August 31, 2004). Both of these deadlines fall within the tenure of the administration that has now proposed the decree. The decree, therefore, will not bind future presidential administrations.
Because the proposed consent decree allows EPA to use its scientific judgment in combination with public notice and comment in the way that Congress envisioned, and because it will not bind future administrations, it does not unduly hamper agency discretion. Accordingly, this is not an impediment to entry of the proposed consent decree.
Objecting plaintiffs and others argue that the proposed consent decree still should not be approved, because the Court lacks both jurisdiction over the complaint and jurisdiction to provide the relief contemplated by the proposed consent decree. Additionally, they maintain that the worker-safety provisions of the proposed consent decree do not result from a meeting of the minds and that the proposed consent decree will require EPA to violate the law. All of these contentions as well as whether the proposed consent decree is fair, equitable, and reasonable, and whether it is within the public interest are addressed below. The threshold issue of jurisdiction is first considered.
Jurisdiction 1. Jurisdiction Over Complaint
According to objecting plaintiffs, the Court cannot approve the proposed consent decree because it lacks jurisdiction over the complaint (AFBF Br. 10-11). In the proceeding AFBF brought against EPA in the District of Columbia, objecting plaintiffs point out, the court dismissed two causes of action for lack of jurisdiction.[7] See Am. Farm Bureau, 121 F. Supp.2d at 97-100. The decision to dismiss the two claims was entirely based on standing. In that case, AFBF claimed that because EPA had failed to abide by its published schedule for tolerance reassessments, AFBF: (i) had suffered a procedural injury; (ii) was deprived of information necessary for investment, compliance, and planning; and (iii) had suffered economic loss because pesticides that had not been reassessed were unfairly labeled as “endocrine disruptors,” and were thus shunned by consumers, whereas if they had been timely reassessed, they would have been shown to be safe. The court held that AFBF’s claimed procedural injury was foreclosed by the section of FFDCA that provides: “the determination of priorities for the review of tolerances and exemptions pursuant to this subsection is not a rulemaking and shall not be subject to judicial review.” Id. at 97 (quoting 21 U.S.C. § 346a(q)(3)). The court rejected AFBF’s informational-injury argument, since FFDCA does not create a right to information. Id. at 97-98. And the court found that in addition to failing to allege a particularized economic injury, AFBF could not establish that such an injury was traceable to EPA’s conduct, as opposed to Congress’s directive to reassess tolerances. Id. at 99-100.
The complaint at issue does not suffer from similar infirmities. Judicial review is proper under 21 U.S.C. § 346a(q)(3) and under the APA. Specifically, the APA provides for judicial review to “compel agency action unlawfully withheld or unreasonably delayed.” 5 U.S.C. § 706(1). FFDCA provides:
The determination of priorities for the review of tolerances and exemptions pursuant to this subsection is not a rulemaking and shall not be subject to judicial review, except that failure to take final action pursuant to the schedule established by this paragraph shall be subject to judicial review.
21 U.S.C. § 346a(q)(3) (emphasis added). According to settling plaintiffs, EPA failed to abide by its published schedule and failed to assess more one-third of the 9,700 tolerances in existence at the time FQPA was passed.[8] Taken as true, these facts provide an adequate basis for jurisdiction, since there is a reviewable action — failure to take action pursuant to the schedule — that was unlawfully withheld. Moreover, settling plaintiffs have alleged a cognizable injury: they allege that members of their groups, such as farm workers, are regularly exposed to harmful pesticides, which is a concrete and particularized injury (e.g., NRDC Compl., Exh. F).
Objecting plaintiffs also argue that EPA has not conceded liability or that jurisdiction over the settling plaintiffs’ complaint exists. No decision has held that an acknowledgment of liability is a jurisdictional prerequisite for the entry of a consent decree. Resolving the merits of this dispute is unnecessary, and indeed defeats the purpose of settlement. Rather, a court may enter a proposed consent decree if the legal “claims alleged in the complaint are more than `wholly insubstantial and frivolous.'” Cronin v. Browner, 898 F. Supp. 1052, 1057
(S.D.N.Y. 1995) (quoting Bell v. Hood, 327 U.S. 678, 776 (1946)). The settling plaintiffs’ complaint is more than adequate.
2. Jurisdiction to Provide Requested Relief
The thrust of objecting plaintiffs’ second jurisdictional argument is that the Court lacks jurisdiction to approve the proposed consent decree, because the suit was brought under FFDCA, yet the proposed consent decree requires EPA to issue REDs, which are part of the FIFRA regime. Objecting plaintiffs contend that under FIFRA, the courts of appeals have exclusive jurisdiction over “reregistration matters” (AFBF Final Br. 7). Since the consent decree sets schedules for achieving re-registration under FIFRA, the Court is without jurisdiction to enter such an order, according to objecting plaintiffs. Both sides agree that the following language from Local Number 93, International Association of Firefighters, AFL-CIO C.L.C. v. City of Cleveland, 478 U.S. 501, 525
(1986), sets forth the applicable standard for the approval of a consent decree:
a consent decree must spring from and serve to resolve a dispute within the court’s subject-matter jurisdiction. Furthermore, consistent with this requirement, the consent decree must come within the general scope of the case made by the pleadings, and must further the objectives of the law upon which the complaint was based. However, in addition to the law which forms the basis of the complaint, the parties’ consent animates the legal force of a consent decree. Therefore, a federal court is not necessarily barred from entering a consent decree merely because the decree provides broader relief than the court could have awarded after a trial.
Objecting plaintiffs focus on the first portion of the passage. They argues that Firefighters creates a two-part test, under which a court may not approve a consent decree unless it (i) resolves a dispute within the court’s subject-matter jurisdiction, and (ii) falls within the general scope of the case made by the pleadings (AFBF Final Br. 6). According to objecting plaintiffs, “Firefighters requires that a court have jurisdiction over all elements, not only of the complaint, but also of the consent decree itself” (id. at 6-7). The settling parties, on the other hand, focus on the second half of this passage — that a consent decree may encompass more relief than could have been obtained at trial.
Contrary to objecting plaintiffs’ view, a court may enter a consent decree that provides relief beyond what a court could otherwise accord so long as some substantial part of it was within its jurisdiction. In Firefighters, for instance, the Court upheld the approval of a consent decree under Title VII, even though a provision of the statute may have rendered federal courts powerless to order the relief provided for in the decree, had the case gone to trial. Id. at 526. Similarly, in Sierra Club, 909 F.2d 1350, the Ninth Circuit upheld a jurisdictional challenge to a consent judgment whereby the defendant agreed to pay money to a private entity for violating the Clean Water Act, despite the CWA’s provision that any fines for violation of the Act must be paid to the United States Treasury. As discussed, there is jurisdiction over this action pursuant to the APA. The consent decree resolves this dispute. That the parties wish to fold other relief into the consent decree does not run afoul of Firefighters, because the consent decree resolves a dispute within this Court’s subject-matter jurisdiction.
Objecting plaintiffs argue that neither Sierra Club nor Firefighters involved relief authorized in a different statute. According to objecting plaintiffs, part of the relief contemplated by the proposed consent decree — the deadlines for REDs — must be provided by the Ninth Circuit, because Congress required that review of EPA decisions made under FIFRA is exclusively within the courts of appeals. No decision, however, has endorsed objecting plaintiffs’ crabbed view. The rationale of Sierra Club and Firefighters is that once a district court has jurisdiction over any substantial part of the decree, the parties may consent to add more relief than could otherwise be obtained. As the Court explained:
it is the agreement of the parties, rather than the force of the law upon which the complaint was originally based, that creates the obligations embodied in a consent decree. Consequently, whatever the limitations Congress placed in § 706(g) on the power of federal courts to impose obligations on employers or unions to remedy violations of Title VII, these simply do not apply when the obligations are created by a consent decree.
Firefighters, 478 U.S. at 522. Moreover, since REDs are not final, reviewable determinations, the proposed consent decree would not preclude the Ninth Circuit from reviewing any subsequent substantive determination made by EPA under FIFRA in contravention of congressional intent. In fact, Congress has required EPA to coordinate reassessments under FFDCA and re-registration under FIFRA, 7 U.S.C. § 136a-1(g)(2)(E)(i)-(iii), and the proposed consent decree helps achieve this end. That the proposed consent decree requires EPA to issue REDs does not prevent its approval.
Objecting plaintiffs also argue that terms of the proposed consent decree do not fall within the general scope of the case made by the pleadings as required by Firefighters. According to objecting plaintiffs, the pleadings are directed to the timing of tolerance reassessments, which are not related to the REDs contemplated by the proposed consent decree (AFBF Final Br. 12). Objecting plaintiffs argue that under Sansome Comm. v. Lynn, 735 F.2d 1535 (3d Cir. 1984), a consent decree must be “directly responsive” to the complaint. Sansome involved a challenge to a consent decree regarding a redevelopment project. The court upheld the validity of the consent decree, reasoning: “Although the terms of the decree far exceeded the relief available under the NEPA and the NHA [National Housing Act], the decree was directly responsive to the Committee’s complaint under those statutes.” Id. at 1539. The Third Circuit’s analysis was no different than the Ninth Circuit’s approach in Sierra Club: both courts looked at the harm alleged in the complaint and whether the consent decree addressed that harm. The case made by the pleadings here is that the “agency has failed to carry out its statutory duties to reassess the safety of and take regulatory action on many chemicals that can have serious adverse effects on humans and cause substantial environmental harm” (NRDC First Amended Compl. ¶ 2). The complaint contains an extensive discussion of FIFRA (id. ¶¶ 15-20). The terms of the proposed consent decree, which establish time-frames for assessing the human and environmental harms posed by certain pesticides are directly responsive to the pleadings and “further the broad objectives upon which the complaint was based.” Sierra Club, 909 F.2d at 1355.
Worker-Safety Provisions
Objecting plaintiffs make the same jurisdictional argument regarding the provisions of the proposed consent decree that require EPA to consider worker safety that they make with regard to the provisions setting deadlines for the issuance of REDs. For the reasons given above, that argument is rejected. Additionally, objecting plaintiffs argue that these provisions are invalid because EPA and settling plaintiffs disagree on the underlying law. They note that EPA claims that nothing in the consent decree requires it “to consider worker risk in reassessing tolerances” (EPA Corrected Reply 16), whereas settling plaintiffs claim “the FFDCA expressly mandates that EPA evaluate all routes of exposure in reassessing tolerances” (NRDC Reply 14-15). According to objecting plaintiffs, there was no “meeting of the minds” before settling plaintiffs and EPA struck the agreement, and therefore the consent decree is not a contract between the parties (AFBF Final Br. 9). To the extent that EPA and settling plaintiffs disagree about the law, this can be taken up if settling plaintiffs ever challenge any of EPA’s substantive rules, which the proposed consent decree leaves them free to do. The consent decree itself is directed to the timing, rather than the substance, of EPA’s decisions. The legal disagreement between the settling parties is not fatal to entry of the proposed consent decree.
Legality
The consent decree is legal because it does not dictate any substantive result: it is directed entirely to timing. As it explicitly states: “Nothing in this Consent Decree shall be interpreted as or constitute a commitment or requirement that EPA obligate or pay funds in contravention of the Anti-Deficiency Act, 31 U.S.C. § 1341, or take any action in contravention of the FFDCA, FIFRA, the APA, or any other law or regulation, either substantive or procedural” (Proposed Consent Decree ¶ 19). Most significantly, nothing in the consent decree deprives any intervenor or objector of the right to challenge any final action by EPA at the administrative or judicial level.
In response to EPA’s posting of the consent decree on its website, the Endosulfan Task Force (an AFBF member) argued that “the Proposed Consent Decree only assures entities outside the EPA an opportunity to address [EPA’s risk-benefits analysis] after the RED is published” (D-16657 at 9).[9] In a similar vein, objecting plaintiffs argue that the proposed consent decree would force EPA to ignore the Tolerance Reassessment Advisory Committee (“TRAC”). TRAC is a 52-member group co-chaired by EPA’s Deputy Administrator and the USDA’s Deputy Secretary. According to EPA, TRAC
was formed consisting of senior-level representatives of a wide variety of stakeholders: environmental/public interest groups, farm worker representatives, pesticide industry and trade associations, farmer and grower organizations, food processors and distributors, State and Federal agencies, pediatricians and public health groups. Moreover, international observers from Canada and Mexico serve on the Committee, and a high number of congressional staff are included as meeting participants.
http://www.epa.gov/oppfead1/trac/aug2000-summary.htm. Even if both objecting plaintiffs and the Endosulfan Task Force are correct, which is disputed (EPA Final Br. 14, 26) and contrary to the Whitman directive, these contentions do not impugn the legality of the proposed consent decree, because neither pre-RED public comment, nor input from TRAC are legally required under any statute.
Because the proposed consent decree is within the Court’s jurisdiction and because its terms are within the law, this order now turns to whether the proposed consent decree is fair, equitable, and reasonable. Objecting plaintiffs and others argue that the settlement process was procedurally unfair, and that the substantive terms are inequitable because they are unbalanced and unreasonable because they will require hasty determinations grounded upon inaccurate data and methods. Publication of studies based on these inaccuracies, they argue, will harm chemical suppliers and farmers.
Fair, Equitable, and Reasonable 1. The Settlement Process
Objecting plaintiffs argue that the negotiation process was improper and collusive. According to objecting plaintiffs, they had been negotiating separately with EPA, and only learned about the proposed settlement through a “surprise conference call” initiated by EPA (AFBF Br. 2). EPA, objecting plaintiffs contend, gave objecting plaintiffs less than two weeks to comment on the decree because “the timing had been dictated by the highest levels of the Agency — i.e., outgoing Clinton appointees” (id. at 3). A long-term agreement made by one administration that binds a subsequent one raises legitimate policy concerns. See Center for Biological Diversity, 2001 WL 777088, at *5.
Whatever concerns may have been raised by the settlement process here have long been dispelled. Due to the public-comment period imposed by the Court and the delays in this case, there has been ample time for the public and the intervenors to respond to the terms of the proposed consent decree. The Court further notes that the present administration does approve of the proposed consent decree and that a Bush appointee, Robert Fabricant, General Counsel for EPA, has signed the proposed consent decree on behalf of the government. The essence of objecting plaintiffs’ argument now seems to be that they themselveswere not included in drafting the proposed settlement of settling plaintiffs’ claims. While there is no legal requirement that the settling parties had to incorporate, or even consider, any of objecting plaintiffs’ views, apparently they did. Nothing that went on in the settlement process now prevents the approval of the proposed consent decree.
2. Fairness
The proposed consent decree appears to be a reasonable compromise, since there is an adequate factual and legal basis, and because the relief embodied in the consent decree is considerably less than what settling plaintiffs sought in their complaint and might have attained had this action gone to trial. Without speculating on what the outcome of this litigation might have been, the Court finds that settling plaintiffs have pursued plausible legal theories that have at least arguable factual support. In their complaint, settling plaintiffs allege that by August 3, 1999, EPA had failed to reassess the safety of all the tolerances for all organophosphates in violation of the schedule published by EPA (NRDC First Amended Compl. ¶ 53). While EPA does not concede that it has failed to follow its schedule, it does admit that organophosphates are “EPA’s top priority for reassessment” (EPA Final Br. 8). See also 62 Fed. Reg. 42,021 (Aug. 4, 1997) (“it is EPA’s intent to conduct tolerance reassessments for organophosphate pesticides in the first three years of the schedule”). Whether or not the statement in the Federal Register was binding on EPA needs not be decided. Since the tolerance reassessments for organophosphates have not been conducted, there is an adequate factual basis for entry of the proposed consent decree as well.
The relief contemplated in the proposed consent decree is much less sweeping than the relief requested by settling plaintiffs. The proposed consent decree merely sets deadlines for REDs and interim REDs for a total of 11 pesticides. A RED is only a precursor to EPA issuing a final tolerance reassessment. Had this action gone to trial, settling plaintiffs may have obtained much broader relief, since they allege that EPA failed to meet the statutory deadlines for tolerance reassessment for around 1,000 pesticides (NRDC First Am. Compl. ¶¶ 59-66). Because the proposed consent decree
3. Timing Requirements
Objecting plaintiffs and numerous objecting members of the public argue that the deadlines in the proposed consent decree will lead to arbitrary decisions in violation of FFDCA, FIFRA, and the APA. According to objecting plaintiffs, to meet the deadline for completing a preliminary cumulative risk assessment for organophosphates, EPA will be unable to develop a valid methodology, “is likely to overstate vastly the risk posed,” and will ignore the most accurate evidence on the toxicity of organophosphates, data regarding the inhibition of cholinesterase in red blood cells (AFBF Final Br. 14-15).[10] They further argue that the deadlines will preclude EPA from considering relevant data that already exists or will soon exist: specifically, the USDA Supplemental Children’s Study, the OP Market Basket Study, a study done by Dow Agrosciences, and human clinical data.
These challenges to EPA’s scientific judgment are unripe. During the rulemaking process, objecting plaintiffs and every other member of the public will have the opportunity to provide any data they wish EPA to evaluate. EPA in its discretion may consider such data or not. Whenever EPA promulgates any final rule, the public can (and surely will) comment on the proposed rule and challenge it at the administrative level and ultimately in court. Since no rules have been issued, it is wholly unknown what studies EPA will eventually consider, what information will be available or considered to be validated by EPA. Under the guise of opposing the entry of the proposed consent decree, objecting plaintiffs are essentially seeking judicial review of non-final agency actions before they have even occurred.
Objecting plaintiffs counter that publication of an erroneous study, even a preliminary one, could damage their businesses. While this possibility exists, objecting plaintiffs fully participate in all the preliminary proceedings, and, indeed maintain that peer review and public input are critical to rational decisionmaking (e.g., Opp. 13-14; Weinstein Decl., dated June 25, 2001, Exh. A, at 2; Exh. B, Exh. G, at 12, Exh. J, at 2, Exh. K, at 3, Exh. N, at 2). EPA should not be penalized for making its decisionmaking process more transparent and subjecting its policies to public comment before they become final. Nor should these preliminary decisions be subject to judicial interference, as this would contravene the Congressional mandate of APA and paralyze the regulatory process. Any RED issued by EPA would have a stigmatic effect similar to the one feared and would not be subject to judicial review. That these preliminary determinations are part of the proposed consent decree does not change this.
EPA says it can meet the deadlines and do so professionally. Deference to the agency Congress has designated to make these determinations is appropriate, especially at such a preliminary stage, where objecting plaintiffs will retain all their statutory rights to notice and comment and judicial review. EPA has submitted declarations indicating that it can consider the very studies objecting plaintiffs deem critical. According to EPA, it can incorporate the “market basket study” into the cumulative risk assessment for organophosphates (Mulkey Decl. ¶ 10) and it will incorporate the children’s study into the final cumulative risk assessment (id. ¶ 11).[11] Based on the human clinical data it has reviewed in the past, EPA’s policy is not to consider such studies (id. ¶ 20). Whether substantial evidence will support this policy, or whether this will be EPA’s policy at the time of any final rulemaking is entirely unknown.
Moreover, many of the objections made by objecting plaintiffs and others are that given the data and methods that currently exist, issuing REDs will require EPA to use assumptions that will be proven wrong by yet-to-be-completed studies. Studying the effects of pesticides is an ongoing process. As will be discussed, the timing requirements of FQPA and the legislative history of both FQPA and FIFRA demonstrate that Congress demanded prompt agency action under these laws. As the court of appeals in the District of Columbia explained in rejecting EPA’s argument that it could ignore current data because it wanted to consult its scientific advisory board first: “All scientific conclusions are subject to some doubt; future, hypothetical findings always have the potential to resolve the doubt. . . . What is significant is Congress’s requirement that the action be taken on the basis of the best available evidence at the time of the rulemaking. The word `available’ would be senseless if construed to mean `expected to be available at some future date.'” Chlorine Chemistry Council v. Envtl. Protection Agency, 206 F.3d 1286, 1291 (D.C. Cir. 2000) (emphasis in original). EPA’s decision to proceed based on the data currently available for some determinations appears entirely reasonable, as FIFRA requires EPA to consider “all data submitted under this section concerning an active ingredient” and “all other available data found by the Administrator to be relevant.”7 U.S.C. § 136a-1(g)(1) (emphasis added). As already stated, the time to challenge whether EPA is legally required to wait for yet-to-be-completed studies is after there has been a final agency action.
Finally, the proposed consent decree postpones deadlines if EPA finds that its methodology or data are flawed and allows for the consideration of new scientific information that could significantly alter EPA’s assessment (Proposed Consent Decree ¶¶ 5, 9d). Whether EPA’s final rules will be based on substantial evidence remains to be seen. The hypothetical scenarios posited by the objectors cannot serve as a basis for refusing to approve the proposed consent decree.
4. The Eleventh-Hour Supplemental Declaration
This ruling was delayed because on August 20, objecting plaintiffs submitted the supplemental declaration of Chris Wilkinson, Michael Ginevan, and Robert Sielken. These experts disagreed with the relative-potency study published by EPA on July 31. This study was generated for calculating the preliminary cumulative-risk assessment for organophosphates, which is required to be completed by December 1, 2001, under the proposed consent decree. As stated, the relative-potency study was reviewed by SAP at a meeting on September 5-6. Two of the three experts above attended the SAP meeting and expressed their views, and AFBF submitted written materials. While objecting plaintiffs argue that the scientific “flaws” in this study show that the proposed consent decree is unreasonable and against the public interest, this declaration simply highlighted the deficiencies in objecting plaintiffs’ scientific arguments.
First, SAP disagreed with objecting plaintiffs’ evaluation of the relative-potency study. Despite objecting plaintiffs’ prediction at the September 6 hearing that SAP would reject EPA’s methodology, exactly the opposite has now occurred. Moreover, SAP rejected some of the specific points raised by objecting plaintiffs’ experts (e.g., SAP Report at 3, rejecting arguments about “B” factors). While SAP did not approve of every single aspect of EPA’s methodology, it stated (SAP Report at 2):
The EPA staff is to be congratulated on a skillful and creative implementation of the basic aspects of the risk modeling approach suggested at the September 2000 SAP meeting on this issue. The Panel consensus was that the major statistical issues raised at the previous meeting have been thoroughly addressed, although many of the panelists recommended further exploration of modeling issues arising out of additional mechanistic considerations especially those that could lead to different expectations for low dose relationships between dose and inhibition response.
This conclusion was entirely consistent with EPA’s representations at the hearing — that SAP might find specific flaws in its method that could be fixed, but that nothing would be found that prevented compliance with the dates in the consent decree using sound science. Citing to comments made by individual SAP members, which are not in the record, objecting plaintiffs argue that SAP’s endorsement was less ringing than the report states. The SAP consensus, however, was as stated above. It is unsurprising that not every panel member shared the same view.
Second, SAP rejected objecting plaintiffs’ argument that EPA would be unable to meet the deadline for the cumulative-risk assessment in the proposed consent decree. Its report stated: “The Panel concluded that it was possible that a draft risk assessment using this hazard and dose response assessment could be completed by December, 2001, and strongly encouraged pursuit of this goal” (SAP Report at 14). Thus, so far, the only peer review of EPA’s work has vindicated its scientific predictions in this litigation.
Third, this relative-potency study is a precursor to a preliminary cumulative-risk assessment, which will be subject to public notice and comment before it becomes a final cumulative-risk assessment. The final cumulative-risk assessment is a precursor to a RED, which is a precursor to a final rule. As they did at the SAP meeting, objecting plaintiffs will have the opportunity to present their views at all of these preliminary stages. Absent the consent decree, no avenue for judicial review of such preliminary actions would exist, as it would allow those who wish to see the regulatory process grind to a halt impose expense and delay on the government at every turn.
Fourth, SAP asked EPA to modify its methodology for the preliminary cumulative-risk assessment. Further modifications will undoubtedly occur before the final cumulative-risk assessment. There is simply no meaningful basis for determining whether the deadline will compel an arbitrary and capricious rule, still years away.
Overall, the SAP report buttresses the points already made: that EPA’s determination that it can meet the deadlines in the proposed consent decree using good science is properly committed to agency discretion, and that EPA has used its discretion in good faith. In sum, this order finds that the proposed consent decree is a fair, equitable, and reasonable settlement of plausible legal claims. EPA’s scientific determination that it will be able to meet the deadlines in the proposed consent decree using good science is due deference and more than adequately supported by the record. While this weighs in favor of approval, the public interest must also be considered.
Public Interest
The consent decree is consonant with the congressional purpose behind FFDCA, FIFRA, and FQPA. In setting the time frames under FFDCA and FIFRA, Congress intended to hasten the reassessment of tolerances and the re-registration of pesticides. For instance, in passing the re-registration requirements to FIFRA in 1988, the House Report noted:
The need for revisions to FIFRA embodied in S. 659 is well documented. In recent years, reviews by this and other Committees of Congress, the General Accounting Office, the National Academy of Sciences, and others have reported on the exceedingly slow pace of the EPA’s progress in completing the reregistration of existing pesticides according to current health and safety standards.
H.R. Rep. No. 939, at 28 (1988). It further noted:
GAO has concluded that at the present rate the reregistration task will not be completed until the year 2024.
Concern about the inadequacy of data that support current pesticide regulations fuels much of the controversy surrounding pesticide use. Such concern, in turn, reinforces the desire by States and their political subdivisions to assert greater control over pesticide use; leads to demands for reform of EPA’s special review and cancellation procedures; prompts calls for more stringent safeguards for workers exposed to pesticides; and generally spurs the effort to limit the use of pesticides. Consequently, the polarized public debate that surrounds pesticide use cannot be expected to subside until a successful reregistration program restores confidence in the regulatory system that governs pesticide approval and use.
The current pace of reregistration thus explains why an accelerated reregistration program is the centerpiece of S. 659.
Id. at 29. In addition to according with Congressional purpose, the proposed consent decree has been approved by the current administration. And, as already discussed, the proposed consent decree preserves all forms of public notice and comment. All these factors, in addition to the deference owed to EPA’s determination as to how to marshal its resources favor finding that the proposed consent decree is within the public interest. This order still considers the comments submitted by members of the public.
Objections from the Public
After publishing the proposed consent decree on its website as ordered, in addition to receiving more than 2,000 comments in support of the proposed consent decree, EPA received around 700 objections. These objections came from individual farmers, state and local farm bureaus, politicians, and agricultural organizations. Several different individuals and entities, such as Joel Ball, County President of Huron County Farm Bureau, submitted a form letter, which stated the following objections: (i) EPA “chose to negotiate with only one of the several parties involved, ignoring farming interests;” (ii) the consent decree is “contradictory to the risk assessment process EPA developed under” TRAC and CARAT (the Committee to Advise on Reassessment and Transition), organizations which represent a broad array of stakeholders; (iii) the deadlines are “arbitrary and unrealistic,” forcing “hasty decisions in the absence of scientific evidence;” and (iv) the proposed consent decree could have a devastating economic impact (e.g., D-16614). These points, and other key concerns raised by objectors are discussed below.
One of the most common public objections was that the proposed consent decree will force EPA to proceed prematurely, causing the EPA to use “default assumptions” far greater than the actual risks. As already discussed, if this occurs, the proper remedy will be to challenge the final agency action based on what evidence EPA chose to consider and what evidence was available. Such a challenge is not precluded by anything in the proposed consent decree.
Another concern frequently raised was that the proposed consent decree will force EPA to ignore input from TRAC and CARAT. Nothing in the proposed consent decree requires such a result, however. Moreover, as stated in the Whitman directive, in developing the proposed consent decree and in obtaining internal approval of it, EPA tried to preserve all of its pre-existing procedures for public comment on non-final agency actions. For instance, the first bullet point of the Whitman directive stated: “The Office of Pesticide Programs (OPP) will use a variety of means to engage the public in discussion on the best means of optimizing public participation in the conduct of the activities covered by the Consent Decree. These will include using the Committee to Advise on Reassessment and Transition (CARAT), either in full sessions or in workgroups, as well as other appropriate methods” (Joint Notice of Filing, dated Mar. 21, 2001, Exh. A, at 1). Indeed, the Whitman directive even established new extra-statutory procedures for allowing public input. For instance: “When issuing each of the four `common mechanism’ determinations required under the Consent Decree, EPA will solicit public comment on its determinations and will revise such determinations if the public comments or other sources provide new data or present new approaches to the examination of the existing data that warrant modification of the Agency’s initial determination” (id. at 3).
Other objectors have argued that entry of the proposed consent decree would inhibit other extra-statutory procedures that EPA has developed. The Minor Crop Farmer Alliance, for instance, went as far as arguing that entry of the proposed consent decree should be delayed until science-policy statements from EPA are promulgated as formal rules (D-16630). Other objectors argued that until some of the science-policy statements were finalized, the consent decree should not be entered (e.g., D-16634). No statutory duty to issue science-policy statements exists. Nor have these policies ever been issued as formal rules. As stated, punishing EPA for voluntarily assure that its decisionmaking process is transparent would create a perverse result.
Similarly, Uniroyal Chemical argues that the deadline for the RED for propargite, September 30, 2001, “fails to provide sufficient time for EPA to follow its own published process for developing the RED” (D-16620 at 1). The Associate Director of the Special Review and Reregistration Division in the Office of Pesticide Programs, however, states that EPA “should have sufficient time before the September 30, 2001 deadline in the Consent Decree for issuance of the propargite RED to review comments on the risk assessment, consult with stakeholders, and draft the RED” (Hounsenger Decl. ¶ 12). Even if EPA were unable to follow all of its extra-statutory procedures for allowing public comment on preliminary agency decisions, it seems to have made a reasonable choice in sacrificing activities that are not statutorily required for ending a legal fight for allegedly failing to perform its statutory duties.
For the reasons already given, the argument that the proposed consent decree was negotiated in a collusive or unfair manner or in a way that ignored objecting plaintiffs’ interests is rejected. A draft of the proposed consent decree was first distributed to the parties in this litigation in January. In April, the final version of the proposed consent decree was published on EPA’s website. It is now September. There has been ample time for public comment and ample time for consideration by the current administration of EPA.
The last frequently-raised argument was that the proposed consent decree will have devastating economic consequences. The proposed consent decree simply requires EPA to evaluate certain chemicals: it does not dictate a particular consequences. Under FIFRA, EPA is required to take into account “the economic, social, and environmental costs” in determining whether a pesticide poses “unreasonable adverse effects on the environment.” 7 U.S.C. § 136(bb). That a pesticide is popular, however, does not exempt it from reassessment or re-registration. Under both FFDCA and FIFRA, EPA is required to give priority to evaluating pesticides that appear to pose the greatest risk to public health: nowhere is it required to assess the economic consequences of performing such re-evaluations. 21 U.S.C. § 346a(q)(2); 7 U.S.C. § 136a-1(c)(1). The economic-consequences argument seems to be a challenge to Congress’s determination that re-evaluation of the most potentially dangerous pesticides had to occur quickly. To the extent EPA fails to properly account for the economic benefits of a given pesticide in any final rule, judicial review will be available.
This order finds no merit in any of the other objections that have not been explicitly addressed. For all the reasons given, the Court finds that the proposed consent decree is fair, reasonable, and equitable, and within the public interest. There is no need for an evidentiary hearing as requested by objecting plaintiffs. Accordingly, EPA and settling plaintiffs’ motion to enter the proposed consent decree is GRANTED.
The AFBF et al. Complaint
The operative complaint brought by AFBF et al. alleges that: (i) the Court lacks jurisdiction over the portions of the consent decree related to FIFRA; (ii) the consent decree violates FFDCA and FIFRA because it precludes EPA from considering relevant information; and (iii) the consent decree is arbitrary and capricious in violation of the APA. For the reasons given in this order, the consent decree is entered, and those causes of action are MOOTED.
Voluntary Dismissal of Count Six
Pursuant to FRCP 41(a)(2), settling plaintiffs and EPA jointly move to dismiss without prejudice count six of settling plaintiffs’ first amended complaint. Count six alleges, inter alia, that EPA has failed to meet the statutory deadline for implementation of an endocrine-disruptor screening program mandated by FFDCA as amended by FQPA. Objecting plaintiffs do not oppose the dismissal. Animal-rights plaintiffs, however, oppose on the ground that they will be prejudiced. Their argument is not that the dismissal itself would be harmful, but rather that the proposed private settlement agreement between EPA and settling plaintiffs would require EPA to embark on creating an endocrine-disruptor screening program without validating its tests properly and without giving due consideration to using tests that do not involve animals.
Under the terms of the proposed private agreement, EPA would make its “best efforts” to implement the endocrine-disruptor screening program proposed in the final report of EPA’s advisory committee, EDSTAC (Compl. ¶ 17). Animal-rights plaintiffs argue that the problems with proposed program are that it: (i) fails to mention specific statutory mandates regarding the validation and approval of testing to be performed; (ii) grants EPA unfettered discretion to avoid using appropriately validated tests; and (iii) “severely undercuts the possibility that new, non-animal screens and tests will be used, thereby ensuring that massive numbers of animals
will suffer and die in the animal screens and tests that EPA has named” (PETA Final Opp. at 13, 25). According to them (id. at 2):
Unless it is modified, the Settlement Agreement threatens to involve the testing of as many as 87,000 substances using an estimated 600,000 to 1.2 million animals for every 1,000 chemicals tested, thus constituting the largest animal testing program in history. EPA continues to commit itself to a lower standard of validation for animal tests than non-animal tests and has failed to agree to requisite consultation and coordination with the Department of Health and Human Services — which is under a duty to replace, reduce and refine animal use in the program.
These contentions do not prevent a dismissal. A “district court should grant a motion for voluntary dismissal unless a defendant can show that it will suffer some plain legal prejudice as a result.” Waller v. Financial Corp. of America, 828 F.2d 579, 583 (9th Cir. 1987) (citing Hamilton v. Firestone Tire Rubber Co, Inc., 679 F.2d 143, 145 (9th Cir. 1982)). “Legal prejudice” can occur, for example: (i) when a partial settlement purports to strip a non-settling party of a legal claim or cause or action, or (ii) when a settlement invalidates the contract rights of a non-settling party. Ibid. As animal-rights plaintiffs acknowledge, they have filed a complaint-in-intervention that alleges that EPA: (i) has violated FFDCA as amended by FQPA and the APA by “fail[ing] to validate the full range of necessary screens and tests for an effective [endocrine-disruptor screening program] for pesticides within the statutory deadlines mandated by Congress;” and (ii) has violated the same statutory provisions “due to its expansion of the program to other classes of chemicals besides pesticides and to other hormone systems besides estrogen” (PETA Compl. ¶¶ 24, 25). In other words, animal-rights plaintiffs’ complaint covers precisely the same ground that is covered by count six of settling plaintiffs’ complaint, and then some. Their complaint protects their interest in this litigation. Since the proposed private agreement is not binding on this Court, animal-rights plaintiffs are free to seek to enjoin EPA from taking action pursuant to it. Since dismissal of count six does not effect animal-rights plaintiffs’ interests in the substance of this litigation, it follows that they will suffer no legal prejudice as a result of the settlement and dismissal of count six of settling plaintiffs’ complaint.
Animal-rights plaintiffs also argue that EPA will not be able to comply with its statutory duty to use “appropriate validated test systems” in implementing an endocrine-disruptor screening program, if EPA must also comply with the schedule set forth in the proposed consent decree resolving counts one through five (PETA Final Opp. at 2). This objection, however, is unrelated to the dismissal of count six. Moreover, as already discussed, EPA cannot evade its statutory obligations, such as notice and comment, under the proposed consent decree. Animal-rights plaintiffs will thus have ample opportunity to contest whether any final rule is grounded on validated testing. Accordingly, the joint motion of settling plaintiffs and EPA to dismiss count six of the first amended complaint pursuant to FRCP 41(a)(2) is GRANTED.
CONCLUSION
For the foregoing reasons, the proposed consent decree is APPROVED and count six of NRDC et al.’s first amended complaint is DISMISSED. AFBF et al.’s complaint is DISMISSED. PETA et al.’s complaint is all that remains of this action. A separate case management order has set a schedule to bring this case to a final conclusion.
IT IS SO ORDERED.