I.2.1 Background

The 1998 congressional directive broadening public access to federally supported research originated in part from a controversy during 1995-97 over implementation of proposed EPA particulate matter regulations under the Clean Air Act (42 U.S.C. § 7401, et seq.). As one basis for the proposed regulations, EPA had cited a major study by the Harvard School of Public Health which tracked the health of some 8,000 people in six cities. During the regulatory review process, industry officials and Congress requested that EPA release the data from the Harvard studies for examination by independent scientists. EPA responded that it had no obligation to provide the underlying data, which were still in the possession of the Harvard researchers. Although the studies had been funded in part by a research grant from EPA, Harvard also refused to make the data available for public reexamination. Only through a special compromise arrangement with an independent institute was a limited reanalysis of the data eventually performed. Results of this reanalysis have yet to be publicized.

The law thus grew out of the perception that Congress, which invests federal agencies with their regulatory authority, and the public, which both funds the studies and experiences first hand the effects of the agencies' regulations, have a right to examine the data upon which federal policy is based. When agencies enact regulations, based upon research data, the public deserves the opportunity to examine the justification for those actions. As Senator Richard Shelby noted, "We need access to the decision-making process. It ought to be based on good science, and regulators ought to be able to defend the science." Otherwise, "lack of public access to research data feeds general public mistrust of the government and undermines support for major regulatory programs."