Regulatory use and acceptance of alternative methods for chemical hazard identification via Science Direct

1 April 2019

Despite the expansion of methods and technologies available for evaluating the safety of environmental chemicals, the uptake of new approaches and acceptance of alternative data in regulatory contexts have been relatively slow.

This may be due to real limitations of alternative methods, as well as the perception that ‘traditional’, animal-based toxicological methods are more protective of human health, although recent meta-analyses of large data sets indicate the contrary in some cases. Animal data often are weighted more heavily in chemical hazard identifications than results derived from alternative methods, particularly when alternative data are negative.

We identified several science-based limitations in alternative methods and propose approaches to reduce the limitations and increase confidence in (particularly negative) results. We also suggest that the limitations of animal data should be clearly communicated to avoid holding nonanimal alternatives to unrealistic performance standards and predictors of human health.

Until the chemical industry can be confident that both positive and negative alternative data will be accepted and regulators can be confident that alternative data are good predictors of the toxicological response, animal tests will continue to be used (where not prohibited) as methods to unequivocally satisfy regulatory data requirements.

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