Strategic Vision for Adopting New Approach Methodologies - Metrics
The U.S. Government Accountability Office (GAO) released a report to Congress in 2019 recommending that Federal agencies develop metrics to assess the progress made toward reducing, refining and replacing animal use in testing. The activities and policies EPA has implemented over the past several years demonstrate significant impacts in reducing the number of animals used in testing and saving resources for the Agency and stakeholders. Additionally, one of the objectives of the Agency's NAMs Workplan is to begin reporting overall baseline metrics and progress by the fourth quarter (Q4) of 2022.
Details on these reduction and replacement metrics are described on their respective pages. EPA’s Pesticide Program reports its progress in the Annual Reports on PRIA Implementation, and began to release specific metrics in FY 2015.
Hazard and Science Policy Council (HASPOC) Metrics
HASPOC reviews data waiver requests for subchronic, chronic, developmental and reproductive toxicity for technical-grade active ingredients related to human health risk assessment. The council uses a weight-of-evidence evaluation to determine data needs that will adequately inform regulatory decision-making, guided by the Part 158 Toxicology Data Requirements: Guidance for Neurotoxicity Battery, Subchronic Inhalation, Subchronic Dermal and Immunotoxicity Studies (May 1, 2013).
| Fiscal year | Granted | Animal Reduction | Cost Savings* |
|---|---|---|---|
| 2018 | 62 | 16,500 | $8,900,000 |
| 2019 | 57 | 22,000 | $8,500,000 |
| 2020 | 36 | 11,800 | $3,500,000 |
| 2021 | 70 | 29,500 | $9,100,000 |
Chemistry and Acute Toxicology Science Advisory Council (CATSAC) Metrics
CATSAC evaluates substantial similarity claims, data citations, and waiver requests for the acute toxicity “six-pack” to support the registration of pesticide products. Learn more about the standard evaluation procedure used by the council to guide these evaluations .
| Fiscal Year | Studies Saved | Animal Reduction | Cost Savings* |
|---|---|---|---|
| 2018 | 18 | 171-384 | $170,400 |
| 2019 | 24 | 255-590 | $284,900 |
| 2020 | 12 | 102-178 | $56,500 |
| 2021 | 18 | 165-410 | $221,700 |
Acute Dermal Retrospective Waiver Request Metrics
Waivers granted under the 2016 Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations & Supporting Retrospective Analysis.
| Fiscal Year | Waivers Granted | Animal Reduction | Cost Savings* |
|---|---|---|---|
| 2018 | 31 | 310-930 | $201,500 |
| 2019 | 37 | 370-1110 | $240,500 |
| 2020 | 30 | 300-900 | $195,000 |
| 2021 | 56 | 560-1680 | $364,000 |
* Cost savings is based on the number of studies and/or waivers granted.
In Vitro Assay Metrics
The number of in vitro assays that were submitted to address the acute toxicity data requirements and support the registration of new pesticide products and the registration review of currently registered pesticides.
| Fiscal Year | in vitro eye irritation assays | in vitro skin irritation assays | in vitro skin sensitization assays |
|---|---|---|---|
| 2018 | 19 | 11 | 1 |
| 2019 | 12 | 7 | 0 |
| 2020 | 13 | 7 | 3 |
| 2021 | 32 | 28 | 12 |