The EPA announced the release of five new policies and guidance documents to advance the Pesticide Program’s (OPP) “Strategic Direction for New Pesticide Testing and Assessment Approaches.” The EPA is developing and evaluating new technologies in molecular, cellular and computational sciences to supplement or replace more traditional methods of toxicity testing and risk assessment. This document creates a framework for hypothesis-based, systematic integration of exposure and hazard information to assess pesticide risk. OPP’s strategic direction is consistent with the 2007 and 2009 National Research Council reports, “Toxicity Testing in the 21st Century: A Vision and a Strategy” and “Science and Decisions: Advancing Risk Assessment.” These actions are significant milestones toward the agency’s longer term vision for a paradigm shift to 21st Century science.
OPP’s new guidance for employees complements and strengthens existing guidance for ecological and human health risk assessment. Together, they are designed to optimize the use of existing knowledge, to provide consistency in our data collection process, and to help our scientists focus on the data needed to reliably support registration decisions that protect public health and the environment while avoiding the generation and evaluation of data that does not materially influence the scientific certainty of a regulatory decision. These guidance documents include:
- “Guiding Principles for Data Requirements” will help guide the identification of data needs for the registration of new pesticides and uses and re-evaluation of existing pesticide uses.
- The “Part 158 Toxicology Data Requirements: Guidance for Neurotoxicity Battery, Subchronic Inhalation, Subchronic Dermal and Immunotoxicity Studies” provides guidance for conducting a weight-of-the-evidence-based evaluation of data needs and requests for waiver. It also addresses how to incorporate the determination into the risk assessment.
- OPP’s Guidance for Selecting, Identifying and Evaluating Open Literature Studies in ecological and human health risk assessments provide guidance for staff in their evaluation of open literature studies of pesticides.
The Pesticide Program is also announcing two new policies that will reduce animal testing through the use of state-of-the-science methods for a more effective and efficient testing and assessment paradigm for chemical risk management:
- The EPA will now accept an alternate testing framework for classification of eye irritation potential for labeling EPA-registered antimicrobial pesticide products with cleaning claims in lieu of the currently used animal test. This new policy, Use of an Alternate Testing Framework for Classification of Eye Irritation Potential of EPA Pesticide Products follows a successful pilot program launched in 2009.
- Our new policy on Combining Genotoxicity Testing with Standard Repeated Dose Toxicology Testing. encourages the incorporation of genotoxicity endpoints into routine toxicology studies where scientifically feasible.