OPP Progress on Reducing Animal Testing & Adopting Alternative Methods - Update for PPDC May 20-21, 2020 Pesticide Program Dialogue Committee Meeting On September 10, 2019, EPA Administrator Andrew Wheeler signed a directive that prioritizes efforts to reduce animal testing (https://www.epa.gov/sites/production/files/2019- 09/documents/image2019-09-09-231249.pdf). The memorandum calls for the agency to: reduce its requests for, and funding of, mammal studies by 30 percent by 2025, and eliminate all mammal study requests and funding by 2035. Any mammal studies requested or funded by EPA after 2035 will require administrator approval on a case-by-case basis. The directive also calls for the formation of a working group of agency experts in this field who will develop a work plan. The work plan is expected to be released in the coming months. EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and Office of Research and Development (ORD) hosted the First Annual Conference on the State of the Science on Development and Use of New Approach Methods (NAMs) for Chemical Safety Testing in December of 2019 (https://www.epa.gov/chemical-research/first-annual-conference-state-science-development-and- use-new-approach-methods-O). OPP is participating in the development of the work plan and helped lead the planning and execution of the conference. OPP continues to make progress towards reducing laboratory animal use. OPP scientists have recently published a paper in the open scientific literature that describes the risk-based, weight of evidence approach used by the Hazard and Science Policy Council for providing waivers for mammalian studies (https://doi.Org/10.1016/i.vrtph.2019.104481). In February of 2020, OPP released its Final Guidance for Waiving Sub-Acute Avian Dietary Tests for Pesticide Registration and Supporting Retrospective Analysis that provides waivers for sub-acute bird studies. The adoption of this guidance is expected to reduce the number of birds tested by approximately 720 birds per year. EPA's guidance is based on a retrospective analysis conducted by EPA and the People for the Ethical Treatment of Animals of avian acute oral and subacute dietary studies. These studies found that EPA can confidently assess acute risk for birds using only the acute oral test for most pesticides (https://www.epa.gov/sites/production/files/2020- 02/documents/final-waiver-guidance-avian-sub-acute-dietary.pdf). OPP continues to work closely with numerous stakeholders on a variety projects such as retrospective analyses on fish acute studies and dermal absorption data and will continue to update the PPDC as progress is made. OPP is soliciting comments from external peer reviewers at two upcoming meetings. In late June, OPP, in collaboration with government, non- government and industry stakeholders, will be presenting the status of several on-going projects related to new approach methods and reducing the use of laboratory animals for chronic and carcinogenicity testing to the Science Advisory Board (SAB). Materials for the June SAB are expected to be posted on the SAB's website in late May. In September 2020, OPP plans to convene a meeting of the Federal Insecticide, Fungicide and Rodenticide Act Scientific Advisory Panel (SAP) on activities related to alternative methods that could inform human health risk assessment for organophosphate pesticides and reduce animal testing for developmental neurotoxicity in the future (https://www.epa.gov/pesticides/epa-hold-scientific-advisory-panel- organophosphates-september). ------- |