Last week, ATS Environmental Health Policy Committee member Meredith McCormack, M,D testified at an EPA public hearing in opposition to the EPA’s proposed rule on data requirements for studies used by the agency in regulatory decision making.  The proposed rule requires that the EPA make publicly available the underlying data from “pivotal regulatory science” studies that the agency relies on to establish major regulatory policy including establishment of standards, exposure thresholds, dose-response relationships and that it informs cost/benefit regulatory calculations.  In describing the proposed rule, the EPA emphasized the need to reveal original data to assure the public of the transparency and “reproducibility” of science used by the agency.

However, sharing original data, particularly in studies on the health effects of air pollution, could violate patient confidentiality.  Such action is both unethical and in violation of federal law.  If the proposed policy were implemented, Dr. McCormack noted that the EPA would be forced to either publicly share data that could expose personal health information or would exclude from their consideration valuable studies that describe the adverse human health effects of air pollution.  Neither option is good policy.

Dr. McCormack further explored concerns with the EPA’s call for reproducible science. She noted that several seminal air pollution studies were based on natural experiments that provide valuable insights on the health effects of exposure to air pollution but are not truly reproducible in a strict sense.  Excluding these studies from the EPA’s consideration would not serve the public welfare. 

Dr. McCormack also observed that calls for transparency, reproducibility and concerns about “secret science” are strikingly similar to the rhetoric the tobacco industry used to undermine science documenting the health effects of tobacco use.