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The data needed by the EPA to support a pesticide regulatory decision (e.g., registration, reregistration, maintenance of a registration, establishment of a tolerance, or exemption from a tolerance) are described in depth at 40 CFR Part 158. But the extensive information may cloud the principle underlying data submissions–that the EPA requires only those data that materially influence the scientific certainty of a regulatory decision. In a recent publication called Guiding Principles for Data Requirements, the Office of Pesticide Programs (OPP) seems particularly concerned that applicants do not submit, nor should the OPP request, data or studies that will congest the application review and delay the decision without playing a meaningful part in the process.
The OPP emphasizes that Part 158 has an inherent flexibility that allows the use of new and emerging tools to support risk assessment and risk management decisions. Summarized below are principles intended to guide the identification of data needs, promote and optimize full use of existing knowledge, and focus on the data needed for a scientifically sound and credible characterization of a specific pesticide’s risk profile for the exposure scenarios of interest.
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Problem Formulation/Risk Management
- Data need to be sufficient for the specific exposure scenario of interest and the risk management decision(s) being made. Additional data should be required only if they can be expected to improve the utility of the risk assessment for decision making (i.e., make a difference in risk conclusions, including those for federally listed species and risk mitigation decisions).
- Before requesting data, OPP reviewers should consider risk management options (e.g., lowering application rates, reduced number of applications, engineering controls, buffer zones).
- Principles for risk assessment
- Not all data listed at 40 CFR 158.45 are necessarily required. Some requirements apply separately to different pesticides (i.e., conventional, microbial, and biochemical active ingredients). In some cases, additional data beyond the established requirements may be needed for risk management decisions.
- Starting from scratch should be avoided, if possible; instead, there should be a reliance on what is already known about the substance and the uses being assessed.
- The scientific rationale for requesting data in the context of the risk assessment and risk management decision should be clear, transparent, and consistent both within and across OPP divisions. It is important to maintain clear distinctions among facts (data), assumptions (best professional judgment specific to an assessment, made in the absence of specific data), and science policy decisions (principles that guide scientific decisions). Because of the uncertainties associated with risk assessment, a qualitative, semiquantitative, and/or quantitative consideration of the strengths and weaknesses of the available hazard and exposure data that impact the risk conclusions (built on information from previous risk assessment(s), if possible) should be presented.
- The decision to request or not request data should be based on a weight-of-evidence approach consisting of the nature of exposure and hazard, the mode of pesticide action, and the mode of toxicity action. Other information, such as open literature and government reports, provides guidance on imparting transparency on how the OPP identifies, selects, and ensures that the data used in pesticide risk assessments are of sufficient scientific quality. Also, bridging data across pesticidal substances can provide assistance in evaluating predicted activities and properties of untested chemicals based on their structural similarity to chemicals with known activities and properties.
- Resources should be focused appropriately regarding the need to refine a risk assessment using integrated, hypothesis-based tiered approaches based on what is known about the toxicity potential and the pesticide uses/exposure.
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Creative Thinking
The OPP says the principles are intended to encourage “creative thinking and innovation.” Moreover, even if additional data were historically required for a chosen review path, scientific considerations should be foremost in determining the need for data. Registrants are also referred to the principles to assist in requesting waivers from data requirements while still meeting their responsibility to show that their pesticides satisfy protection standards established by federal law.