In light of a recent lawsuit settlement over the 2006 regulation that established protections for subjects of human research, the Environmental Protection Agency will no accept studies using human test subjects as guinea pigs.
According to EPA officials, the federal rules must be rewritten under a new agreement reached between the agency and public-health groups, farm-worker advocates and environmental organizations. The revised rules will address three principal areas: the scope of the rule, its consistency with the 2004 National Academy of Science recommendations, and its consistency with the Nuremberg Code, a code written in response to WWII human experimentations.
These proposed amendments will be presented to the Federal Register before Jan. 16, 2011.
In 2006, EPA passed a regulation that accepted data on pesticide use obtained through human testing. The Natural Resources Defense Council quickly responded with a lawsuit stating the legislation went around the human-experimentation regulations.
On June 16, the lawsuit was settled. According to EPA, “Under the settlement, EPA agrees to propose amendments to the final human studies rule by Jan. 16, 2011.”
The agency added, “The sweeping requirements of EPA’s rules will lay the groundwork and provide an important foundation for the agency to build upon in future actions that may be determined necessary to provide further protections to public health.”