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Public Comment Sought Regarding Human Testing Data

Release Date: 05/09/2003
Contact Information:

David Deegan 202-564-7839/

(05/09/03) On May 7, EPA published an Advance Notice of Proposed Rulemaking (ANPR) in the Federal Register to solicit public comment about criteria and standards the Agency would use in deciding the extent to which it will rely on certain kinds of human research to support its actions to protect public health and the environment. This notice begins a process to establish rigorous scientific and ethical standards that EPA would apply in its analysis of various types of research involving people exposed to toxicants to identify or quantify their effects. The Agency will particularly focus on “third-party intentional dosing human studies,” but recognizes that standards applicable to these studies may also be applicable to other types of studies. “Third party studies” refers to research not conducted or supported by EPA or other federal agencies, and therefore not governed by the Common Rule to ensure that human test subjects have adequate protections. The Agency is seeking public comments on how to determine the extent to which it will consider or rely on results from particular types of studies involving human subjects, and how EPA might be able to establish robust standards for the protection of human subjects, in preparation for developing a rule or policy on this issue. The Agency’s focus in developing a future policy or rule must be protection of the welfare of human research subjects and adherence to the most rigorous ethical and scientific standards. Along with public comments, EPA will also carefully consider advice expected later this year from the National Academy of Sciences. This process will allow EPA to review its approach to human subjects research and develop a rule or policy in a transparent and participatory manner. Comments on this ANPR will be accepted for 90 days. The Federal Register notice can be found at: