Bridging or Waiving Data Requirements

Pesticide registrants can request a waiver of data requirements or seek to bridge data from one data set to another.

The documents below explain our approach to data waivers.

The 2020 “Final Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Single-Active Ingredient and Supporting Retrospective Analysis” will allow for data waivers for acute dermal studies for single-active ingredients used to develop end use products. The document includes a policy statement to waive all acute lethality dermal studies for single-active ingredients.

The 2020 “Fish Bioconcentration Data Requirement: Guidance for Selection of Number of Treatment Concentrations” clarifies EPA’s recommendations for the number of treatment concentrations needed to result in acceptable fish bioconcentration factor (BCF) studies for pesticide registration. EPA expects that this policy change will result in savings of approximately 240 test animals per year as well as EPA, industry and laboratory resources in conducting and reviewing BCF studies.

The 2020 “Final Guidance for Waiving Sub-Acute Avian Dietary Tests for Pesticide Registration and Supporting Retrospective Analysis” provides supporting retrospective analysis and additional points to consider when evaluating subacute avian dietary tests data waivers for pesticide registration. Waiving requirements for toxicity studies when they offer little additional scientific information or public health protection is an important component of the policy, which emphasizes avoiding unnecessary resource use, data generation costs, and animal testing.

The 2016 "Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations and Supporting Retrospective Analysis" expands the potential for data waivers for acute dermal studies for formulated products. The document includes a policy statement to waive all acute lethality dermal studies for formulated pesticide products (see section 3.0).

The 2012 "Guidance for Waiving or Bridging of Mammalian Acute Toxicity Tests for Pesticides and Pesticide Products" consolidated previous guidance on waivers for acute toxicity tests. It noted that generally, waivers are considered when data to support a particular endpoint are not relevant to the chemical. Criteria are included for such waivers.

Learn more about pesticide data requirements.