Pesticides are some of the most tested and strictly regulated chemicals requiring the use of more than 8,000 animals for human safety and another 2,000 animals for ecological safety. In December 2021, EPA released their work plan for establishing scientific confidence in New Assessment Methods (NAMs) and applying them to their regulatory decisions. Syngenta is developing an approach to generate the information necessary to meet the regulatory requirements for a new pesticide registration without the use of chemical-specific vertebrate tests. Our first case study is for a new ACCase inhibitor herbicide. The human and environmental risk assessment approach involved the estimation of potential exposure and comparing that to hazard endpoints. For the hazard component to address human safety, a comparative assessment of 14 ACCase herbicides and insecticides registered by the USEPA was performed, working on the hypothesis that hazard for a new ACCase inhibitor can be defined based on data from existing registered ACCase inhibitors. Similarly, for aquatic and terrestrial vertebrate species, chemical toxicity distributions were developed with data extracted from USEPA ecological risk assessment documents. Human and environmental exposure were estimated using standard regulatory assessment methods and tools based on the proposed uses of the new active ingredient.<br/>The USEPA has issued guidance that allows the acceptance of alternative approaches or sufficient information in lieu of a guideline study thus enabling a specific test guideline study to be waived. The NAMs applied in this approach will be mapped to the standard pesticide registration package to satisfy the regulatory requirements. Waivers will be developed providing sufficient scientific rigor and will be submitted in lieu of the traditional animal studies. In addition to an overview of the scientific methods to address the key knowledge needs without the use of chemical-specific vertebrate tests, a possible structure for the registration package of the future will be presented

Development of a regulatory package for a new herbicide without the use of animal testing

Fall 2022 abstracts, posters, and presentations will launch in mid-September.

ACS Fall 2022

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.