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Parsons P, Freeman E, Weidling R, et al. Using existing knowledge for the risk evaluation of crop protection products in order to guide exposure driven data generation strategies and minimise unnecessary animal testing. Crit Rev Toxicol. 2021;51(7):600-621doi: 10.1080/10408444.2021.1987384.
Parsons, P., Freeman, E., Weidling, R., Williams, G. L., Gill, P., & Byron, N. (2021). Using existing knowledge for the risk evaluation of crop protection products in order to guide exposure driven data generation strategies and minimise unnecessary animal testing. Critical reviews in toxicology, 51(7), 600-621. https://doi.org/10.1080/10408444.2021.1987384
Parsons, Paul, et al. "Using existing knowledge for the risk evaluation of crop protection products in order to guide exposure driven data generation strategies and minimise unnecessary animal testing." Critical reviews in toxicology vol. 51,7 (2021): 600-621. doi: https://doi.org/10.1080/10408444.2021.1987384
Parsons P, Freeman E, Weidling R, Williams GL, Gill P, Byron N. Using existing knowledge for the risk evaluation of crop protection products in order to guide exposure driven data generation strategies and minimise unnecessary animal testing. Crit Rev Toxicol. 2021 Aug;51(7):600-621. doi: 10.1080/10408444.2021.1987384. Epub 2021 Nov 10. PMID: 34756157.
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Crit Rev Toxicol. 2021 Aug;51(7):600-621. doi: 10.1080/10408444.2021.1987384. Epub 2021 Nov 10.

Using existing knowledge for the risk evaluation of crop protection products in order to guide exposure driven data generation strategies and minimise unnecessary animal testing.

Critical reviews in toxicology

Paul Parsons, Elaine Freeman, Ryan Weidling, Gary L Williams, Philip Gill, Neil Byron

Affiliations

  1. Exponent® International Limited, Harrogate, UK.
  2. Exponent Inc, Washington DC, USA.

PMID: 34756157 DOI: 10.1080/10408444.2021.1987384

Abstract

Traditionally, human health risk assessment focuses on defining the hazard through mammalian toxicity studies followed by exposure estimation. We have explored ways of predicting exposure based primarily on the use scenario and comparing the exposure to reference dose values derived by various regulatory agencies (US EPA, JMPR, and EU Commission) in order to identify mammalian toxicity studies that are relevant to human health risk assessment. Human dietary exposure was based on existing residue data for substances with comparable use on the same or similar crops. Human occupational exposures were based on the use scenarios and application methods. To provide a point of comparison for the exposure predictions, data were collated for acute, chronic and occupational reference dose values derived by various regulatory agencies (US EPA, JMPR, and EU Commission). The exposure predictions and range of hazard endpoints were compared using the ILSI HESI Risk21 risk matrix plots in order to visualise and contextualise the level of potential concern for the exposure prediction. In addition, an approach is proposed to categorise the likelihood of acceptability of risk based on where the exposure sits relative to the distribution of reference dose values. The approaches proposed in this study allow for exposure prediction based on the Good Agricultural Practice (GAP) in conjunction with the use of existing hazard data for crop protection products in order to make an initial determination on acceptability of risk and to identify key studies that are required for human health risk assessment and also opportunities for study waivers.

Keywords: Exposure prediction; acceptability of risk; exposure driven testing strategy; human health risk assessment; reduction in animal use; reference dose derivation; study waivers

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