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Guidance for Identifying, Selecting and Evaluating Open Literature Studies

This page provides guidance for Office of Pesticide Program (OPP) staff to assist in their evaluation of open literature studies of pesticides. Consistent with the Open Government Initiative, this guidance is also intended to make transparent to the public how we identify, select, and ensure that the data we use in pesticide risk assessments is of sufficient scientific quality.

Overview of Sources of Information Considered and Evaluation Procedures for Pesticides

OPP considers multiple sources of information when conducting risk assessments for pesticides, not just studies conducted specifically to support pesticide registration. The studies that are the most relevant and informative to risk assessment are those that clearly and fully describe study design, conduct and methods, as well as providing access to the underlying data.

We have a public and well documented set of procedures for the evaluation and use of data to inform risk management decisions. Studies to generate data in response to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requirements are conducted under, and the results evaluated in accordance with, a series of internationally harmonized and scientifically peer-reviewed study protocols. These protocols are designed to maintain a high standard of scientific quality and ensure that study results can be repeated.

Evaluation of Open Literature Studies

We also are committed to considering other sources of information, including data identified in the open literature and information submitted by the public to the regulatory docket for a pesticide evaluation. We encourage the public to submit such studies for evaluation.

The following two guidance documents address the use of open literature studies in ecological and human health risk assessments:

These documents describe how OPP risk assessors search the literature and evaluate the quality and utility of open literature studies in a transparent and systematic manner to identify those non-test-guideline data that are pertinent for consideration in weight-of-evidence analyses that would support risk assessment and regulatory decision making.

The principles articulated in these documents are consistent with the agency’s policy and procedural guidance for ensuring and maximizing the quality of information EPA 2002 - Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency (61 pp, 895k, About PDF) and the agency Risk Characterization Policy, (189 pp, 2MB, About PDF), which describes a philosophy of transparency, clarity, consistency, and reasonableness.

These documents supersede existing OPP guidance on this topic and are immediately effective.

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