Record Display for the EPA National Library Catalog


Main Title Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations & Supporting Retrospective Analysis.
CORP Author Environmental Protection Agency, Washington, DC. Office of Pesticide Programs.
Year Published 2016
Stock Number PB2017-101089
Additional Subjects Pesticides ; Toxicity ; Testing ; Skin (Anatomy) ; Acute dermal toxicity ; Federal regulations ; Toxicity tests ; Public health ; Environmental health ; Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Library Call Number Additional Info Location Last
NTIS  PB2017-101089 Some EPA libraries have a fiche copy filed under the call number shown. 07/26/2022
Collation 12p
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes EPA to register pesticides and require supporting studies to meet statutory safety standards as stipulated under 40 Code of Federal Regulations (CFR) Part 158. There is flexibility, however, in implementing Part 158. Additional data can be required, alternative approaches can be accepted, and studies can be waived. The 2007 NAS report on Toxicity Testing in the 21st Century describes a new vision for toxicity testing. EPA’s Office of Pesticide Programs has developed a Strategic Direction for New Pesticide Testing and Assessment Approaches which describes OPP’s approach to implementing the NAS vision. One component of OPP’s strategic vision describes the need for improved approaches to more traditional toxicity tests to minimize the number of animals used while expanding the amount of information obtained. OPP’s document on Guiding Principles for Data Requirements notes the importance of only requiring data that inform regulatory decision making and avoid unnecessary use of time and resources, data generation costs, and animal testing. Waiving studies, when such data offer little or no additional scientific information or public health protection, is an important component of the guiding principles for data requirements. OPP staff can focus on the information most relevant to a particular assessment and still ensure there is sufficient information for regulatory decisions that are protective of public health and the environment.