Opinion ID: 3154163
Heading Depth: 2
Heading Rank: 1

Heading: Limitations in Tier 2 Studies

Text: The EPA’s regulations require the EPA to “Review[] all relevant data in [its] possession” and to “determine[] that no additional data are necessary” to make determinations of no unreasonable adverse effects. 40 C.F.R. § 152.112(b)–(c). The regulations also require “field testing for pollinators” to be submitted as part of an application for registration if data from other sources indicates a risk to honey bees. 40 C.F.R. § 158.630(d) and (e) n.25. All parties agree that, because some data indicated a potential risk of adverse effects on honey bee colonies, Dow was required to submit pollinator field testing. In the White Paper addressing the new tiered POLLINATOR STEWARDSHIP COUNCIL V. U.S.E.P.A. 19 risk assessment framework for pollinators, the framework drafters noted that while the requirement of “field testing for pollinators” in 40 C.F.R. § 158.630 is general, semi-field studies would satisfy that requirement. What data Dow submitted did not support approval of sulfoxaflor at either the proposed maximum rate of 0.133 pounds of active ingredient per acre or the reduced maximum rate of 0.09 pounds of active ingredient. In its original conditional registration decision, the EPA had required additional testing per “OECD guidance.” The record reveals a number of deficiencies in Dow’s submitted semi-field studies, most of which did not conform to OECD guidelines. Although the EPA’s regulations do not mandate that studies be performed in accordance with OECD guidelines, the regulations state that studies done in accordance with OECD protocol will suffice to meet the data requirements of FIFRA. 40 C.F.R. § 158.70(d)(2). Some of the deficiencies in Dow’s submitted studies were unrelated to the fact that these studies did not comply with OECD guidelines. Such deficiencies included limitations inherent in the tunnel study design, such as the fact that bees undergo significant stress when placed in a tunnel, and some limitations related to the fact that the application rates used were generally much lower than the maximum proposed application rate. Some of the limitations would have been ameliorated, however, had the studies conformed with OECD guidance. For example, proper controls could have been used, the studies could have been replicated more times, and the bees could have been observed for a longer period of time after being removed from the tunnels. 20 POLLINATOR STEWARDSHIP COUNCIL V. U.S.E.P.A. One of the problems the EPA originally identified with the Tier 2 studies was that only one of the studies used the proposed maximum application rate, 0.133 pounds per acre, and that study, Ythier 2012, was designed for quantifying residue, not studying biological effects. Yet, at the lower rate that the EPA approved, 0.09 pounds per acre, the studies provided only slightly more data about the effects of application. Portions of only two different studies provided data regarding the effects of sulfoxaflor at the maximum application rate of 0.09 pounds per acre: Ythier 2012 used an application rate at or above 0.089 pounds per acre for four of its seven applications. Hecht-Rost 2009 used an application rate of 0.088 pounds per acre as one of its five applications. The Ythier 2012 study, because it was designed to quantify plant residues, not biological effects, had other limitations. It did not assess forager mortality, flight intensity, forager behavior, or reference toxicant effects (meaning the effect of sulfoxaflor as compared to known toxic chemicals on control tunnels), and it did not include any concurrent controls for interpreting biological effects or brood development. These were noted in the EPA’s environmental assessment. Hecht-Rost 2009 also had a number of limitations: there was an infestation of a pest, Varroa mite, which can kill honey bee colonies; there was a long pre-exposure period in the tunnels of 11 days, which, given that bees are stressed by being in tunnels, compromises the data; the colonies varied widely between the different tunnels; there was a short observation period of only 7 days; and there were few larvae in the tunnels. Furthermore, Hecht-Rost 2009 included no observation after the hives were removed from the tunnels. POLLINATOR STEWARDSHIP COUNCIL V. U.S.E.P.A. 21 And only one of the five applications provided data about an application rate around 0.09 pounds per acre. Moreover, all of the studies, regardless of application rate, suffered from an additional significant flaw: they provided inconclusive or insufficient data on the effects of sulfoxaflor on brood development and long-term colony health. Because the honey bee colony is an interdependent “superorganism,” the effect of an insecticide on one type of bee can ripple through the hive. The two studies that provided the best data for evaluating the effects on brood development, Schmitzer 2011a and 2011b, used application rates less than half of the EPA’s new maximum rate of 0.09 pounds per acre. In these two studies, the measurements for brood termination rate (the number of brood that fail to develop through to emergence) in the control tunnels was quite high, with 56% and 65% of the brood failing to survive. By comparison, other studies done according to OECD Guideline 75 reported brood termination control rates of 8–43% in five control studies, with three of the five controls reporting high brood termination rates only because of poor weather. Because the brood failed to emerge at high rates even in the control tunnels in the Schmitzer studies, the controls were not suitable for comparison with the brood termination rates of the tunnels treated with sulfoxaflor; thus, there was inconclusive data as to the effect of sulfoxaflor on brood termination rate. Accordingly, even these two studies reveal little about the effect of sulfoxaflor on brood development, both due to the low application rates used and due to problems with the control tunnels that caused high brood losses. 22 POLLINATOR STEWARDSHIP COUNCIL V. U.S.E.P.A. In addition, all of the semi-field studies provided limited information about longer term effects on colony strength. The three studies with valid controls that studied colony strength all used application rates of about half the new maximum application rate. The studies that did not have valid controls measured colony strength before and after application and did not discern a measurable decline in colony strength; however, these studies measured colony health over a relatively short time period, between 7 and 17 days after sulfoxaflor treatment. The EPA assessment acknowledged that different negative effects could appear on the hive-level over a longer time period: for example, the death of foraging bees that occurs immediately after sulfoxaflor is sprayed might lead to premature recruitment of hive bees into the forager work force. It was on the basis of all of these deficiencies and others it noted, that the EPA in January 2013 concluded that it needed additional studies regarding the effect on brood development and long-term colony strength. That was when the EPA decided to grant sulfoxaflor only conditional registration. Though the EPA specified in January that the additional studies were necessary to evaluate whether sulfoxaflor could ever be used at the maximum proposed application rate of 0.133 pounds of active ingredient per acre, and unconditional approval in May 2013 was for a lower application rate, the limitations of the data regarding brood development and longterm colony strength exist even with the lowered application rate of 0.09 pounds per acre. By the EPA’s own reckoning, the data was insufficient to evaluate the effect of sulfoxaflor on brood development and long-term colony strength. The POLLINATOR STEWARDSHIP COUNCIL V. U.S.E.P.A. 23 decisions are not consistent. The later, unconditional approval lacks support. In addition to needing studies on brood development and long-term colony strength, it is clear that the EPA was lacking sufficient data on the impact of sulfoxaflor generally even at the reduced application rate of 0.09 pounds of active ingredient per acre. The EPA had only portions of two studies evaluating the effects of sulfoxaflor at that rate. And the EPA also recognized in its proposed conditional registration that it needed more studies regarding the residue of sulfoxaflor that appears in nectar and pollen in a crop that is pollinator-attractive, such as canola. On the basis of the studies submitted, the EPA lacked substantial evidence to support its conclusions that application of sulfoxaflor at a rate of 0.09 pounds per acre would not have an unreasonable adverse effect on the environment. The EPA and Dow argue that since the studies are inconclusive as to the risks of sulfoxaflor for bees, the studies affirmatively prove that sulfoxaflor does not cause unreasonable adverse effects on bees. Neither logic nor precedent can sustain this position. We have previously held that an agency cannot rely on ambiguous studies as evidence of a conclusion that the studies do not support. See Tucson Herpetological Soc. v. Salazar, 566 F.3d 870, 879 (9th Cir. 2009) (finding that the Secretary of the Interior erred when he affirmatively relied on ambiguous and inconclusive studies to support a conclusion). The limitations of the underlying data in this case mean that no such conclusion can be reached. The EPA also argues that Tier 2 studies are only required when analysis at the Tier 1 phase shows measurements above the level of concern and, at the lower application rate of 0.09 24 POLLINATOR STEWARDSHIP COUNCIL V. U.S.E.P.A. pounds of active ingredient per acre, few of the residue measurements were high enough to trigger the acute level of concern. Thus, the EPA asks us to conclude the showing was “close enough” so as not to trigger the requirement for Tier 2 studies. The EPA therefore contends that it is irrelevant that the Tier 2 studies are severely flawed. This argument just does not fly. It is true that, at the lower rate of 0.09 pounds per acre, only 2 of the 66 nectar measurements and 1 of the 66 pollen measurements in the Ythier 2012 study were above the level of concern. And only 1 of the nectar measurements in the other residue studies (MRIDs 48476601, 48445806, 48755601) was above the level of concern. It may well be true, as the EPA argues, that its definition of the “level of concern” is inherently conservative. But at least some of the measurements do exceed the level of concern, and where data indicates a potential risk to pollinators, the EPA’s regulations mandate pollinator field testing. 40 C.F.R. § 158.630(d) and (e) n.25 (table showing data requirements for nontarget terrestrial and aquatic organisms, including honey bees). Moreover, the EPA’s assessment noted significant shortcomings in the residue studies which created uncertainty in the extrapolation of the results and which may have understated the risk. The EPA acted in accordance with its regulations and common sense in proceeding to Tier 2. We have previously held that we cannot allow the EPA to avoid its own regulations when actual measurements trigger risk concerns, even where the measurements were “in the neighborhood” of measurements that would not trigger such concern. We have said such an argument may be “well taken as a practical matter” but is “irrelevant as a legal matter.” See Natural Res. Def. Council v. EPA, 735 F.3d 873, 883–84 (9th POLLINATOR STEWARDSHIP COUNCIL V. U.S.E.P.A. 25 Cir. 2013) (holding that, where risk concern was triggered by a measurement less than or equal to 1,000, and one of four treatments measured exactly 1,000, the EPA could not argue that the risk concern was not triggered). The EPA had similarly argued in that case that its calculations were based on very conservative assumptions, so a risk estimate that was “close” to the threshold was close enough. Id. We rejected that argument, holding that we cannot “revise EPA’s assumptions, alter its rule of decision, or perform our own risk assessment.” Id. The same is true here. The EPA chose to set its level of concern at a measurement it now feels is overly conservative, but a court cannot alter the agency’s own rule. And because the EPA set its level of concern accordingly, and because at least some of the residue measurements with the lower application rate of 0.09 pounds per acre still triggered the acute level of concern, pollinator field testing was required. That requirement cannot be met by portions of two studies which are limited in a variety of ways, particularly as regards brood development and long-term colony strength – and particularly given that the EPA itself recognized those limitations. “It is well-established that an agency’s action must be upheld, if at all, on the basis articulated by the agency itself.” Motor Vehicle Mfrs. Ass’n of the U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 50 (1983) (internal citation omitted). The EPA’s basis for unconditionally registering sulfoxaflor in the absence of sufficient data documenting the risk to bees does not hold up under its own rationale. Without sufficient data, the EPA has no real idea whether sulfoxaflor will cause unreasonable adverse effects on bees, as prohibited by FIFRA. Accordingly, the EPA’s decision to 26 POLLINATOR STEWARDSHIP COUNCIL V. U.S.E.P.A. register sulfoxaflor was not supported by substantial evidence. The matter must be remanded to the agency. We need not reach the other claims of error raised by petitioners.