EPA Strengthens Safeguards

GPN Weekly first reported in September 2005 that the Environmental Protection Agency (EPA) had proposed a rule to establish stringent, enforceable safeguards governing the conduct of third-party intentional dosing research with human subjects. Recently, the EPA put those rules in effect, meaning all third-party intentional dosing research on pesticides involving children and pregnant women intended for submission to EPA is banned, and EPA will neither conduct nor support any intentional dosing studies that involve pregnant women or children for all substances EPA regulates. These final new rules also establish stringent enforceable ethical safeguards to protect individuals who volunteer to participate in third-party intentional dosing research.

“These final rules will protect pregnant women and children from unethical human research involving pesticides and other environmental substances,” said Susan B. Hazen, acting assistant administrator in EPA’s Office of Prevention, Pesticides and Toxic Substances. “Pregnant women and children should never be involved in these types of studies. Now adult volunteers (non-pregnant) will have the highest level of ethical safeguards available if they choose to participate in research studies.”

These final regulations adopt and implement many of the recommendations from the National Academy of Sciences, have benefited from public comments, and adhere to the legislation passed by Congress in August 2005. Under the new rules, the provisions of the Federal Policy for the Protection of Human Subjects of Research (the Common Rule) are extended to cover all third-party intentional dosing studies submitted to EPA under the pesticide laws. Third party studies are those studies not conducted or supported by a federal agency.