US suggests testing chemicals on humans.

US suggests testing chemicals on humans.

Studies in which human subjects are deliberately dosed with pesticides should be allowed to form part of regulatory submissions, according to the US National Academies’ National Research Council (NRC). In a recently published report, the NRC concludes that such studies are justified as long as they are conducted ’with the utmost caution and care’.

The NRC produced its report at the request of the Environmental Protection Agency (EPA), which is responsible for regulating all toxic chemicals in the US, including pesticides. The EPA had come under pressure from a number of agrochemical companies to accept data from human studies in order to develop accurate reference doses for safe pesticide exposure. The NRC therefore formed a special committee that conducted a year-long review of the ethics of testing pesticides and other potentially toxic chemicals on humans.

In its report, the NRC argued that data from human studies should be permissible, but only providing a number of strict criteria are met.

These include: that the studies should address important regulatory questions that cannot be answered without human testing; that benefits to society must outweigh any anticipated risks to the participants; and that if the sole purpose of a study is to improve the accuracy of reference doses then there should be no obvious risks to participants.

The NRC also recommended that the EPA should set up a Human Studies Review Board. Consultation with this board would then become an essential requirement before any company or organisation wishing to carry out tests on humans could proceed.

’Improving the quality of the science used for regulatory purposes is itself a worthy social goal,’ commented Michael Taylor, co-chair of the review committee, ’but it could never justify harming human research participants.’

Jon Evans