TABLE 2.
US, Canada, and EU: pesticides and plant protection products.
| Agency | Strategic plans, guidance, and other documentation for the implementation of NAMs referenced in this manuscript |
|---|---|
| EPA OPP | • Guidance for waiving or bridging of acute EPA, (2012); EPA, (2016a); EPA, (2020c) and repeat dose EPA, (2013b) toxicity tests for pesticides (for formulations and single-active ingredients) |
| • Use of an alternate testing framework for classification of eye irritation potential of EPA pesticide products EPA, (2015) | |
| • Process for evaluating & implementing alternative approaches to traditional in vivo acute toxicity studies for FIFRA regulatory use EPA, (2016b) | |
| • Interim science policy: Use of alternative approaches for skin sensitization as a replacement for laboratory animal testing EPA, (2018b) | |
| • Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for DNT Bal-Price et al, (2018a) a | |
| • Utility of In Vitro Bioactivity as a Lower Bound Estimate of In Vivo Adverse Effect Levels and in Risk-Based Prioritization Paul Friedman et al. (2020) a | |
| • New approach methods work plan, reducing use of animals in chemical testing EPA, (2021e) b | |
| • Retrospective analysis of the dermal absorption “triple pack” data Allen et al. (2021) | |
| • Performance of the GHS Mixtures Equation for Predicting Acute Oral Toxicity Hamm et al. (2021) | |
| • Integration of toxicodynamic and toxicokinetic new approach methods into a WoE analysis for pesticide DNT assessment Dobreniecki et al. (2022) | |
| • ReCAAP: A reporting framework to support a weight of evidence safety assessment without long-term rodent bioassays EPA, (2020f); Hilton et al. (2022) | |
| HC PMRA | • Guidance for waiving or bridging of mammalian acute toxicity tests for pesticides HC, (2013a); Acute Dermal Toxicity Study Waiver HC, (2017) |
| • PMRA’s 2016–2021 strategic plan HC, (2016d) | |
| • Canadian regulatory perspective on next generation risk assessments for pest control products and industrial chemicals Bhuller et al. (2021) | |
| • Guidance for developing datasets for conventional pest control product applications HC, (2021d) | |
| • ReCAAP: A reporting framework to support a weight of evidence safety assessment without long-term rodent bioassays Hilton et al. (2022) | |
| EFSA | • Guidance on dermal absorption EFSA et al. (2017) |
| • OECD/EFSA workshop on DNT: The use of non-animal test methods for regulatory purposes Fritsche et al. (2017) | |
| • Reconnecting exposure, toxicokinetics and toxicity in food safety: OpenFoodTox and TKplate for human health, animal health and ecological risk assessment Dorne et al. (2018) | |
| • Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for DNT Bal-Price et al. (2018a) | |
| • Workshop on in vitro comparative metabolism studies in regulatory pesticide risk assessment EFSA, (2019) | |
| • Advancing human health risk assessment Lanzoni et al. (2019) | |
| • Utility of In Vitro Bioactivity as a Lower Bound Estimate of In Vivo Adverse Effect Levels and in Risk-Based Prioritization Paul Friedman et al. (2020) | |
| • Development of IATA case studies on DNT risk assessment EFSA PPR Panel et al. (2021) | |
| • EFSA Strategy 2027 EFSA, (2021) | |
| • Development of a Roadmap for Action on New Approach Methodologies in Risk Assessment Escher et al. (2022) |
a
EPA Office of Research and Development (ORD) involved.
b
Applicable to all EPA offices.
EFSA, European Food Safety Authority; EPA OPP, Environmental Protection Agency Office of Pesticide Programs; FIFRA, Federal Insecticide, Fungicide, and Rodenticide Act; HC PMRA, Health Canada Pest Management Regulatory Agency; NAM, new approach methodologies. ReCAAP, Rethinking Chronic toxicity and Carcinogenicity Assessment for Agrochemicals Project.