On July 7, 2014, the Natural Resources Defense Council (NRDC) filed with the U.S. Environmental Protection Agency (EPA) a petition requesting that EPA commence a Special Review for the neonicotinoid pesticides, including six specific active ingredients (dinotefuran, acetamiprid, clothianidin, thiacloprid, imidacloprid, and thiamethoxam), based on the risk that NRDC believes this class of compounds poses to honey bees and native bees. In the petition, NRDC alleges that neonicotinoids "may suppress bee immunity, disrupt brood cycles, impair foraging behavior by interfering with memory and learning, and cause disorientation, preventing bees from finding their way back to the hive." By submitting this petition, NRDC effectively asks that EPA expedite the evaluation of the effect of this class of active ingredients on pollinators that EPA already intends to undertake as part of the Registration Review process required by Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(g), 7 U.S.C. § 136a(g). A copy of the petition is available online.
In filing this petition, NRDC is also asking EPA to revive a largely moribund Special Review process. Although procedures for Special Review are set forth in 40 C.F.R. Part 154, the last formal action taken by EPA pursuant to those procedures was in 2008. At one time, EPA utilized Special Review (previously known as the Rebuttable Presumption Against Registration program or RPAR) as the principal vehicle for evaluation of pesticides for which additional risk mitigation measures might be needed to satisfy the standard for registration under FIFRA. In recent years, Special Review has been largely supplanted by the substantive evaluations of registrability that were required by the formal reregistration process created by the 1988 Amendments to FIFRA Section 4, 7 U.S.C. § 136a-1.
All of the neonicotinoid active ingredients were first registered after 1984, so they were not subject to reregistration under FIFRA Section 4. As such, the principal vehicle for evaluation of the neonicotinoids would typically be Registration Review, a process that EPA is required to complete for each active ingredient every 15 years. Although EPA has commenced Registration Review for each of the six active ingredients listed by NRDC, decisions on any needed risk mitigation measures are not scheduled to issue until from 2017 to 2019. In its petition, NRDC asks EPA to initiate Special Review for all of the neonicotinoids within 30 days and to complete that Special Review within one year. Because NRDC contends that the neonicotinoids are implicated in severe declines in bee populations in recent years, it believes that expedited action is needed.
Special Review Process
Despite its currently moribund status, the Special Review process remains available to EPA. EPA is most likely to decide to utilize Special Review in a scenario where EPA concludes that expedited study of specific risks posed by a pesticide is necessary, but EPA is not yet in a position where it can decide on risk mitigation measures that may be needed to satisfy FIFRA requirements. Nevertheless, it is not clear that EPA will deem the neonicotinoids to be appropriate candidates for Special Review.
The asserted role of neonicotinoids in declining bee populations (also referred to as Colony Collapse Disorder or CCD) is highly controversial. Some scientists believe that the information is sufficient to conclude that neonicotinoids are contributing to this problem, while other scientists cite evidence that factors other than exposure to neonicotinoids are likely to blame or at least contributing substantially to the problem. In 2013, the European Union (EU) adopted a two-year moratorium on certain uses of neonicotinoids, based in large measure on a report by the European Food Safety Authority that concluded that these uses posed a potential acute risk to honey bees. This action in the EU should be contrasted with a 2012 White Paper on risk assessment for bees coauthored by EPA, which concluded that the role of neonicotinoids and other potential causes in declining bee populations could not be established without further study.
Although Special Review provides a formal vehicle for additional study that is more expedited than the 15-year interval for Registration Review, the Special Review process was established by EPA by rulemaking rather than by statute. The only statutory reference to Special Review is the section on "interim administrative review" in FIFRA Section 3(c)(8), 7 U.S.C. § 136a(c)(8), which was added in the 1978 Amendments to FIFRA. This section was intended to restrict the circumstances in which EPA could initiate a Special Review (then known as RPAR), by requiring a "validated test or other significant evidence raising prudent concerns of unreasonable adverse risk to man or to the environment." In the 1985 final rule that changed the name of the interim administrative review process from RPAR to Special Review, EPA adopted definitions of the terms "validated test" and "other significant evidence" that were taken directly from the 1978 Conference Report enacting FIFRA Section 3(c)(8).
In the same 1985 final rule, EPA altered the criteria for initiation of Special Review to allow EPA greater flexibility and discretion in deciding when to commence Special Review. Under the RPAR process, EPA was required to initiate the process for any active ingredient found to have acute toxicity exceeding a specified numerical value or found to induce certain types of chronic effects at any level. EPA concluded that this mechanistic process "could prevent the Agency from focusing its resources on pesticides having the most potential for harm to the public or the environment." The amended Special Review criteria adopted in 1985 allow EPA to consider exposure information, and to make judgments concerning the weight of the scientific evidence, in selecting appropriate candidates for Special Review.
The final rule for Special Review adopted in 1985 also created a formal docketing process, required that EPA prepare a memorandum describing every meeting with a person or party outside of government concerning a pending Special Review, and afforded opposing parties 30 days to comment after each such memorandum is placed in the docket before any final action. These procedures were required by a 1985 settlement of litigation in which NRDC and others asserted that registrants had been afforded preferential access to EPA in the development and issuance of RPAR decisions and Registration Standards (the predecessor to Reregistration Eligibility Decisions). The current NRDC petition does not assert that EPA has violated any of the procedures adopted pursuant to that 1985 settlement. Because the procedures for Special Review adopted in 1985 were more restrictive and formal than the procedures previously utilized for RPAR decisions, it may be that this formality contributed to the subsequent decline in EPA's use of Special Review. In any case, the creation of a detailed reregistration process in the 1988 FIFRA amendments reduced the need for EPA to utilize a separate public process to make risk mitigation decisions.
Curiously, although the NRDC petition describes in detail the evidence that NRDC asserts implicates neonicotinoids in declining bee populations, NRDC does not identify which specific criterion for Special Review it believes has been met, or explain how the cited scientific evidence bears on this criterion. Nevertheless, it is clear that the applicable criterion would be 40 C.F.R. § 154.7(a)(3), which provides that EPA may conduct a Special Review if a pesticide:
May result in residues in the environment of nontarget organisms at levels which equal or exceed concentrations acutely or chronically toxic to such organisms, or at levels which produce adverse reproductive effects in such organisms, as determined from tests conducted on representative species or from other appropriate data.
Perhaps NRDC did not attempt to apply this criterion because it requires EPA to utilize substantial administrative discretion in interpreting and weighing the scientific evidence, but it is also possible that EPA or the registrants of the affected active ingredients will cite this as a deficiency in the NRDC petition.
In its petition, NRDC also notes that at least some initial registrations granted for the neonicotinoid active ingredients were conditional registrations issued under FIFRA Section 3(c)(7)(C), 7 U.S.C. § 136a(c)(7)(C), and required the registrant to develop and submit specific supporting data. NRDC cites a recent Government Accountability Office (GAO) report that described deficiencies in EPA's administration of the conditional registration program, and expresses a measure of skepticism that EPA has properly determined that any applicable conditions imposed under FIFRA Section 3(c)(7)(C) have been met. Accordingly, NRDC requests that as part of its response, EPA provide: a specific accounting of which neonicotinoid active ingredients were conditionally registered, what studies were required, whether and when those studies were submitted, whether EPA reviewed the submitted studies, and what any EPA review of the submitted studies found.
In responding to the NRDC petition, EPA is likely to discuss a Presidential Memorandum issued on June 20, 2014, in which President Obama created a Pollinator Health Task Force that will have 180 days to develop a National Pollinator Health Strategy, including a Pollinator Research Action Plan. In the same Presidential Memorandum, the President stated EPA "shall assess the effect of pesticides, including neonicotinoids, on bee and other pollinator health and take action, as appropriate, to protect pollinators." (A more detailed memorandum on the Presidential Memorandum is available online.) EPA may contend that starting a Special Review would duplicate or perhaps even interfere with study of the scientific evidence by the Task Force. On the other hand, EPA could cite the President's specific directive concerning neonicotinoids as part of its rationale for responding favorably to the NRDC petition.
NRDC's argument that a Special Review should be initiated for the neonicotinoids is a relatively novel one given the moribund nature of the process. It may be that NRDC believes that requesting Special Review will move EPA closer to completing a review of the effect of pesticides on bees and related pollinator issues that EPA has publicly committed to conduct a number of times in the past 18 months. In addition, the claim of defects in the conditional registration procedures continues a recent theme by non-governmental organizations (NGO) that EPA has not adequately reviewed new pesticidal active ingredients before allowing their introduction. The pollinator issue is used by NGOs as a marquee example of how more review and data are needed before approving any pesticide product.