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 activities are described on their respective pages. EPA’s Pesticide Program began to release specific metrics on NAMS implementation, including animal reduction and replacement, in the FY 2015 Annual Report on PRIA Implementation within the Process Improvements in the Pesticide Program chapter. Links to the PRIA reports between FY2015-FY2018 can be found here.
Hazard and Science Policy Council (HASPOC) Metrics
HASPOC primarily reviews data waiver requests for repeat dosing studies (e.g., 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 Savings1 | EPA Review 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 | |
| 2022 | 31 | 8,116 | $2,960,000 | |
| 2023 | 41 | 10,024 | $15,700,0002 | $378,7463 |
| 1Study cost savings are based on the number and type of study waivers granted. 2Calculated using updated cost estimate values (April 2022). 3For the purposes of these metrics, EPA savings are calculated as the cost of preliminary contractor review based on the number and type of study + an additional 20% added for EPA toxicologist/committee review. OPP began tracking this metric in FY23. |
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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.
Starting in FY2022, Office of Pesticide Programs (OPP) divisions have been able to make most acute toxicity determinations at the branch level without CATSAC consultation. As a result, there were no CATSAC recommendations on study needs in FY2022 and a limited number of submissions reviewed by CATSAC in FY2023. Instead, CATSAC consultations have recently focused on registrant rebuttals and submissions with more complex arguments for waiver requests. Efforts are underway to revise the CATSAC standard operating procedure (SOP) to appropriately reflect how OPP is currently utilizing the council.
| Fiscal Year | Studies Saved | Animal Reduction | Cost Savings1 | EPA Review Cost Savings4 |
|---|---|---|---|---|
| 2018 | 18 | 171-384 | $170,400 | |
| 2019 | 24 | 255-590 | $284,900 | |
| 2020 | 12 | 102-178 | $56,500 | |
| 2021 | 18 | 165-410 | $221,700 | |
| 2023 | 8 | 68-162 | $98,6002 | $7,862 |
| 1Study cost savings are based on the number and type of study waivers granted. 2Calculated using updated cost estimate values (April 2022). 3Animal use may range in acute toxicity tests depending on whether a limit test or main test was conducted. 4For the purposes of these metrics, EPA savings are calculated as the cost of preliminary contractor review based on the number and type of study + an additional 20% added for EPA toxicologist/committee review. OPP began tracking this metric in FY23. |
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Given the change in the focus of the CATSAC consultations, OPP’s registering divisions—the Registration Division (RD), the Antimicrobials Division (AD), and the Biopesticides and Pollution Prevention Division (BPPD)—have started to capture animal reduction and cost saving metrics for branch-level decisions. This new metric also includes branch-level decisions that were not previously captured by the CATSAC metrics where acute toxicity testing was not necessary to support the registration of new pesticide products. The studies saved in the table below include data citations, data bridging requests, additional study waiver requests, and weight-of-evidence approaches (or rationales) for AD, BPPD, and RD.
| Fiscal Year | Studies Saved | Animal Reduction | Cost Savings1 | EPA Review Cost Savings3 |
|---|---|---|---|---|
| 2023 | 1122 | 9415-18026 | $12,004,5002 | $1,102,702 |
| 1Study cost savings are based on the number and type of study waivers granted. 2Calculated using updated cost estimate values (April 2022). 3For the purposes of these metrics, EPA savings are calculated as the cost of preliminary contractor review based on the number and type of study + an additional 20% added for EPA toxicologist/committee review. OPP began tracking this metric in FY23. |
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Acute Dermal Retrospective Waiver Request Metrics
Applicants for pesticide registration have the option to submit data waivers for acute dermal toxicity testing in accordance with the Agency’s 2016. In 2018, OPP began tracking waivers granted under the 2016 Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations & Supporting Retrospective Analysis. Beginning in FY21, data waivers citing the 2016 waiver guidance on formulations and the 2020 Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Technical Chemicals & Supporting Retrospective Analysis are combined.
| Fiscal Year | Waivers Granted | Animal Reduction | Cost Savings | EPA Review 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 | |
| 2022 | 61 | 610-1830 | $396,5002 | |
| 2023 | 47 | 470-1410 | $305,5002 | $46,192 |
| 1Study cost savings are based on the number and type of study waivers granted. 2Calculated using updated cost estimate values (April 2022). 3Animal use may range in acute toxicity tests depending on whether a limit test or main test was conducted. 4For the purposes of these metrics, EPA savings are calculated as the cost of preliminary contractor. |
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In Vitro Assay Metrics
OPP has published two science policies that utilize NAMs for replacement of in vivo eye irritation and skin sensitization tests described on this page. In addition, OPP evaluates in vitro data from OECD test guidelines on a case-by-case basis and may use these methods with other lines of evidence in a weight of evidence approach for decisions regarding acute toxicity data needs. The table below includes 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 |
| 2022 | 17 | 13 | 7 |
| 2023 | 7 | 2 | 3 |