Strategic Vision for Adopting New Approach Methodologies - Reduction Strategies
One of EPA’s goals is to reduce laboratory animal studies while maintaining the scientific rigor of pesticide assessments. EPA published its Guiding Principles for Data Requirements on May 31, 2013, to ensure there are sufficient data to support scientifically sound risk characterizations that are health protective while avoiding the generation of data that do not contribute relevant information to a pesticide’s risk profile.
EPA has already taken steps in reducing unnecessary laboratory testing through promoting the use of inter-divisional scientific committees, the publication of guidance documents that allow for the waiving of existing data requirements in certain scenarios, and applying existing toxicological data for chemically similar substances (data bridging).
- Acute Toxicity Waiving and Bridging Guidance
- Acute Dermal Toxicity Tests for Pesticide Single-Active Ingredient
- Acute Dermal Toxicity Waiver Guidance for Pesticide Formulations
- Part 158 Toxicology Data Requirements & Hazard and Science Policy Council (HASPOC)
- Sub-Acute Avian Dietary Test Waiver Guidance
- M010 – Substantially similar determination
- Fish Bioconcentration Data Requirement
- Retrospective Analyses of Fish Acute Toxicity Data
Guidance for Waiving or Bridging of Mammalian Acute Toxicity Tests for Pesticides and Pesticide Products
EPA published this guidance document in 2012 to provide a foundation for reducing redundant or unnecessary testing of laboratory animals. This consolidates previous guidance on waivers for acute toxicity tests. Criteria are included for requesting testing waivers.
Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Single-Active Ingredient and Supporting Retrospective Analysis
In 2020, EPA issued the proposed dermal toxicity guidance for a 30-day public comment period. The guidance will allow waivers for studies on single-active ingredients used to develop end use products to apply for waivers. In developing the guidance, EPA conducted a retrospective analysis and concluded that its requirements for such studies provides little to no added value in regulatory decision making.
Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations and Supporting Retrospective Analysis
In 2016, EPA completed this document related to the 2012 guidance document above to provide more specific information on how to waive acute dermal toxicity data requirements for new pesticide formulations. The document includes a policy statement to waive all acute lethality dermal studies for formulated pesticide products.
Part 158 Toxicology Data Requirements and the Hazard and Science Policy Council (HASPOC)
EPA’s Part 158 Toxicology Data Requirements: Guidance for Neurotoxicity Battery, Subchronic Inhalation, Subchronic Dermal and Immunotoxicity Studies (May 1, 2013) provides guidance on using a weight-of-evidence evaluation to determine data needs in risk assessment. The goal is to only require data that adequately inform regulatory decision-making and avoid unnecessary animal testing.
The Hazard and Science Policy Council (HASPOC) is an inter-divisional forum to address science, policy, hazard data waivers, and risk deliberation and coordination issues in connection to Part 158 data requirements. HASPOC plays an important role in moving toward smarter testing strategies by waiving toxicity studies that do not provide useful information for regulatory decisions. Additionally, HASPOC exercises flexibility by considering a weight-of-evidence approach when determining data needs and safety determinations.
Learn more about the metrics on HASPOC achievements and study waiver approvals.
Guidance for Waiving Sub-Acute Avian Dietary Tests for Pesticide Registration and Supporting Retrospective Analysis
This guidance, released in 2020, provides supporting retrospective analysis and additional considerations for pesticide registration when evaluating data waivers for subacute avian dietary tests. Waiving requirements for toxicity studies when they offer little additional scientific information or public health protection is an important component of the document, which emphasizes avoiding unnecessary resource use, data generation costs, and animal testing.
Chemistry and Acute Toxicology Science Advisory Council (CATSAC)
EEPA formalized the Chemistry and Acute Toxicology Science Advisory Council (CATSAC) in 2016 to reduce unnecessary animal testing across divisions in OPP by bridging and/or waiving acute toxicity and product chemistry studies that do not provide useful information for product registration. In 2017, the standard operating procedure was finalized and continues to guide internal processes. In 2019, the standard evaluation procedure was finalized to provide guidance on criteria used to determine substantial similarity between pesticide products and allow for bridging or citing existing data.
Learn more about the metrics on CATSAC achievements and waiver approvals.
M010 PRIA Code – Pre-Application Product Substantial Similarity Determination
Under the M010 PRIA code, an applicant can seek a "conditional ruling by EPA on the substantial similarity between a cited, registered product and a not-yet submitted new product or product amendment". This code allows for a pre-decisional determination indicating whether cited acute toxicity and/or product chemistry studies would adequately address requirements for a new or amended product registration.
Fish Bioconcentration Data Requirement: Guidance for Selection of Number of Treatment Concentrations
In July 2020, EPA released this guidance, which outlines the criteria for the number of treatment concentrations needed for an acceptable Fish Bioconcentration Factor (BCF) study. The guidance is also a supplement to OCSPP Test Guideline 850.1730. The Agency expects that most studies will require only two test concentration levels instead of three, thereby reducing the number of test animals used by approximately 240 per year
Retrospective Analyses of Fish Acute Toxicity Data
Fish acute toxicity tests are conducted using both a cold and warm freshwater species and a saltwater species to assess the effects of pesticides on non-target aquatic vertebrates. A retrospective analysis was conducted to determine if fewer than three fish species are needed for the risk assessment of conventional pesticides. The results support potentially using fewer than three fish species to conduct ecological risk assessments for conventional pesticides and may be considered when determining chemical-specific testing requirements. The analyses, including supplementary data, are available in the following manuscript: Ceger et al. (2023). Evaluation of the fish acute toxicity test for pesticide registration. Regulatory Toxicology and Pharmacology.