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Adopting 21st-Century Science Methodologies—Metrics

On Sept, 10, 2019, EPA Administrator Andrew Wheeler issued a directive to prioritize efforts to reduce animal testing, which included the goals of reducing mammal study requests and funding 30 percent by 2025 and eliminating them by 2035. The administrator’s directive specifically charged the Agency to establish baselines, measurements and reporting mechanisms to track its progress. 

Additionally, 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.

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 FY2015.

On this page:

Hazard and Science Policy Council (HASPOC) Metrics

HASPOC reviews data waiver requests for subchronic, chronic and developmental toxicity and reproduction 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

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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

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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

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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.

Fiscal Year in vitro eye irritation assays in vitro skin irritation assays in vitro skin sensitization assays
2018 25 13 1
2019 12 7 0

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