The opinion of the court was delivered by: Denise Cote, District Judge
The United States Environmental Protection Agency ("EPA" or "defendant") registered an insecticide in violation of its statutory duties to publish notice, invite public comment, and publish its registration decisions. This case presents the question of whether the EPA's registration should be vacated in light of these defects. It should be.
The Natural Resources Defense Council ("NRDC"), a nonprofit environmental advocacy organization, and the Xerces Society (collectively, "plaintiffs"), a nonprofit wildlife conservation organization, challenge the EPA's registration of the insecticide spirotetramat under the Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), 7 U.S.C. § 136 et seq., claiming procedural and substantive deficiencies in the EPA's approval of it. Plaintiffs are concerned about the effect spirotetramat has on bees.
Intervenor defendant Bayer CropScience ("Bayer") developed spirotetramat and markets it. Spirotetramat is an insecticide that prevents the synthesis of fats necessary for cell reproduction in insects, which reduces the fertility of female adult insects and the survival of the insect offspring.
FIFRA requires an insecticide containing a new active ingredient to be registered by the EPA in order to be distributed and sold in the United States. 7 U.S.C. § 136a. Insecticide manufacturers must therefore submit an application that contains information about the insecticide's chemical characteristics, mode of action, intended uses, and human health and environmental harms. 7 U.S.C. § 136a(c); 40 C.F.R. Part 158. Between October 2006 and April 2007, Bayer submitted five applications to register spirotetramat under FIFRA for use on various crops in different formulations.
Upon receiving an application, the EPA must publish in the Federal Register a "notice of each application," and solicit comments for at least thirty days. 7 U.S.C. § 136a(c)(4). The EPA concedes that it failed to publish the required notices of applications by Bayer for spirotetramat and invite public comments on those applications.*fn1
The EPA may register a pesticide if it determines, inter alia, that the pesticide "will perform its intended function without unreasonable adverse effects on the environment." 7 U.S.C. § 136a(c)(5). FIFRA defines "unreasonable adverse effects on the environment" in part as, "any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide." 7 U.S.C. § 136(bb). An application may be approved with or without the condition that further data be submitted to the agency. 7 U.S.C. § 136a(c)(7)(C). In addition, the EPA must determine what conditions of use, if any, to list on the pesticide label. 7 U.S.C. § 136a(c)(5)(B) & 136a(d)(1).
Upon receiving Bayer's applications, the EPA collaborated with Canadian and Austrian counterpart agencies to analyze spirotetramat. The agencies reviewed hundreds of studies in order to assess the insecticide's impact on human and animal health, on non-target organisms, and on the environment. Based on its findings, the EPA conditionally approved Bayer's applications in decisions of June 30, August 8, September 24, and December 16, 2008, which allowed the use of spirotetramat on hundreds of crops.
In the registration process, the EPA identified concerns about the insecticide's effect on bees. The EPA's review of tests exposing honeybees to spirotetramat found, inter alia, "increased mortality in adults and pupae, massive perturbation of brood development, early brood development, and decreased larval abundance." The EPA further found that insecticides that inhibit lipid biosynthesis have "potential for chronic effects on bee broods and development" and "may adversely affect bee broods and development;" and in 2007 the EPA found there is "uncertainty regarding the potential chronic effects of spirotetramat on pollinators because no long-term data were available." By the time the EPA made its registration decision in June 2008, it had reviewed additional studies on spirotetramat's chronic effect on bees, but it still found the data lacking because the chronic effect studies tested spirotetramat at levels lower than the label-recommended application rate.
The EPA therefore conditioned its approval of spirotetramat on the completion of studies plugging the data gaps on the chronic effects of spirotetramat on bees.*fn2 Additionally, it required all end-use products containing spirotetramat to include the following language on their warning labels:
This product is potentially toxic to honey bee larvae through residues in pollen and nectar, but not to adult honey bees. Exposure of adult bees to direct treatment or residues on blooming crops can lead to effects on honey bee larvae. See the "Directions for Use" section of this label for specific crop application instructions that minimize risk to honey bee larvae.
The "directions for use" for specific crops prohibited using spirotetramat on plants during those periods when the plants are flowering and are most likely to attract bees.
Within thirty days of approving an insecticide, the EPA must publicly disclose all information supporting the application, id. § 136a(c)(2)(A), and it must publish in the Federal Register a "notice of issuance" of the registration that includes a description of the new insecticide, a summary of the agency's regulatory conclusions, and responses to comments received on the notice of application. 40 C.F.R. § 152.102. In June 2008, the EPA published on its website a spirotetramat "Pesticide Fact Sheet," which explained that spirotetramat had been conditionally registered, and summarized the EPA's rationale behind that decision. The EPA concedes, however, that it did not publish a notice of registration in the Federal Register for any of these decisions until August 6, 2009, three months after the plaintiffs filed this lawsuit.
FIFRA provides procedures for canceling the registration of a pesticide. If the EPA determines that a registered pesticide causes "unreasonable adverse effects on the environment," the EPA must order a public hearing; or it must consult with the Secretary of Agriculture and then give interested parties notice of its intent to cancel the registration, and those parties may request a public hearing. 7 U.S.C. § 136d(b). If the EPA holds a hearing, an Administrative Law Judge ("ALJ") may subpoena testimony or documents; and the ALJ must refer relevant questions of scientific fact to a Committee of the National Academy of Sciences if a party requests a referral or if the ALJ determines it is ...