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

Heading: Explanation and Connection with Data

Text: Setting aside the EPA’s procedure, I still do not find that the EPA supported its decision with a satisfactory explanation that was rationally connected to the facts. Specifically, I return to the EPA’s only clear statement explaining how it arrived at its final decision: “After review of the public comments and further consideration of the database, EPA has concluded that an unconditional registration of sulfoxaflor, with lowered application rates and other mitigation is supported by available data and therefore the appropriate regulatory decision.” The obvious questions in reading this POLLINATOR STEWARDSHIP COUNCIL V. U.S.E.P.A. 35 explanation are: (1) What “database”? and (2) What “available data”? As the reviewing court, we must know the answers to these questions. Yet, the EPA never explains which data it included in its analysis. From the record, it seems certain that the EPA relied on two sets of studies in making its final decision: the Tier 1 and Tier 2 studies, which were conducted to determine whether sulfoxaflor posed a risk to pollinators when applied at the maximum application rate of 0.133 lbs a.i./A. In other words, to unconditionally register sulfoxaflor at the maximum application rate of 0.09 lbs a.i./A, the EPA relied on: (1) the same Tier 1 studies that found sulfoxaflor’s risk of effects on all life stages and castes of bees exceeded the level of concern; and (2) the same Tier 2 studies that the EPA called unreliable in the executive summary of its Environmental Fate and Ecological Risk Assessment for Sulfoxaflor Registration. To be fair, the EPA only found the Tier 2 studies unreliable as to data on colony strength and brood development, not direct effects, but this does not lessen the import of that critique. Nor did the EPA’s concerns disappear after further review of the data. In its Decision Document, the EPA wrote: “The effect of sulfoxaflor on brood development is considered inconclusive due to the limitations associated with the available studies . . . .” It continued: “[T]he design of the Tier 2 studies does not enable the potential for longterm effects [on colonies ]to be discounted completely.” The EPA has also provided us with no basis to determine whether the original and refined Tier 1 studies or the six Tier 2 studies conformed with procedural standards. Not only has the EPA done a poor job explaining how many tests were run and what results followed, the EPA has also failed to provide any comparison for us to determine what number of tests and 36 POLLINATOR STEWARDSHIP COUNCIL V. U.S.E.P.A. what range of results are acceptable. The only guidelines we have to compare with the studies are the Organization for Economic Cooperation and Development (OECD) guidelines and the Office of Chemical Safety and Pollution Prevention (OCSPP) guidelines. The EPA does not refer to either guideline in describing the tests Dow conducted for sulfoxaflor. Instead, the EPA acknowledges that the semifield studies submitted for Tier 2 did not comport with OECD guidelines. The EPA argues that the EPA compensated for any uncertainties in the Tier 1 and Tier 2 studies by adopting mitigation measures. However, the EPA has not pointed to any studies in the record showing that the EPA obtained data on these mitigation measures. Nor does the EPA point to any scientific studies or testimony in the record to support its conclusions regarding the mitigation measures. See Lands Council, 537 F.3d at 994. The EPA periodically refers to other data in the “database” throughout its responses to public comments on the proposed conditional registration, but none of these data are explained in detail in the record. For instance, the EPA refers to an “extensive analysis” of outside studies: The EPA conducted an extensive analysis of sulfoxaflor in collaboration with counterpart agencies in Canada and Australia. Scientists from all three authorities reviewed over 400 studies, peer reviewed the primary evaluations conducted by their international colleagues, and communicated extensively on specific disciplines and issues. Additional EPA POLLINATOR STEWARDSHIP COUNCIL V. U.S.E.P.A. 37 committees further reviewed the work done under the joint review project. However, the EPA never explained the type of studies, how they were conducted, or what results were obtained. Nor did the EPA explain the outcome of its “extensive analysis,” whether this analysis conformed with similar analyses for other pesticides, or even how the EPA relied on the analysis in making its final decision. The EPA certainly did not explain any conclusions drawn from those studies or the reasons it considered the studies to be reliable. See Lands Council, 537 F.3d at 994. Of equal concern is the EPA’s reliance on data not in the database. In its responses to public comments, the EPA frequently cites lack of information as support for its final decision. For instance, as evidence that sulfoxaflor will not cause honey bee losses, the EPA states that it “has received no reports [of] any sulfoxaflor-related incidents from the 2012 use under section 18 [emergency exemption] authorizations. The state lead agencies informed EPA that they were not asked to conduct any investigations and they received no reports of adverse incidents.” And to bolster its claims that sulfoxaflor is better than the pesticides sulfoxaflor will replace, the EPA states that it is “not aware of any information that would indicate that honey bee losses as a result of exposure to sulfoxaflor would exceed or be any different than those currently experienced with currently registered insecticides.” The EPA cites no studies. It is worth noting that the record contains evidence that the pesticides sulfoxaflor would replace are more harmful to honey bees than sulfoxaflor. However, the EPA has not pointed to this evidence or demonstrated that it deems those studies reliable. See N. Plains Res. Council, Inc., 668 F.3d at 1075. Nor has 38 POLLINATOR STEWARDSHIP COUNCIL V. U.S.E.P.A. the EPA provided a connection between the evidence in the record and the EPA’s decision. State Farm, 463 U.S. at 43. Rather than citing to definitive information, the EPA repeatedly dismisses data gaps and inconclusive evidence with the explanation that the EPA “believed,” “had knowledge,” or “relied on its best professional judgement.” For instance, the EPA states: “Although statistical weaknesses were documented for [the Tier 2 studies], the Agency did not rely exclusively on statistical interpretation of results in its risk findings. Rather, it relied on its best professional judgment in evaluating the magnitude and duration of effects from these studies.” The EPA also said: Although results from longer-term tunnel studies conducted at the current maximum single application rate of 0.086 lb a.i./A are desirable for confirming the results of the Tier 1 risk assessment, the Agency believes that when results of Tier 1 and the proposed mitigation measures are considered, the existing limitations in the Tier 2 studies do not preclude registration of sulfoxaflor given the mitigation measures (such as reduced application rates and increased minimum spray intervals) that are included on the label and the benefits provided by sulfoxaflor. Although the EPA certainly has authority to rely on its wellfounded beliefs, scientifically-derived knowledge, and experience-driven professional judgment, it must support the beliefs, knowledge, and judgment with evidence. We will continue to grant agencies great deference, particularly in cases, such as this one, which involve “substantial agency POLLINATOR STEWARDSHIP COUNCIL V. U.S.E.P.A. 39 expertise.” Marsh, 490 U.S. at 376. However, there is a great difference between ordering an agency to “explain every possible scientific uncertainty,” Lands Council, 537 F.3d at 988, and requiring it to “articulate a satisfactory explanation for its action” that is based on scientific data, State Farm, 463 U.S. at 43. Professional judgment and knowledge do not meet the substantial evidence standard independent of data and facts. Otherwise, the standard could always be met with the sworn declaration of an expert stating the expert’s experience alone made his opinion trustworthy. For me, unless I am provided with evidence of the EPA’s basis for its judgment and knowledge, I can only assume it acted with none.