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Summary. Every year, the federal government considers over 4,000 regulations, some of which can cost billions. The scientific and research data used to make decisions about these regulations must be of the highest quality in order to ensure that proposed regulations will actually benefit the public. However, it is often the case that the people who ultimately pay for the research, the taxpayers, do not have access to the research upon which a proposed government regulation based.
Summary. Every year, the federal government considers over 4,000 regulations, some of which can cost billions. The scientific and research data used to make decisions about these regulations must be of the highest quality in order to ensure that proposed regulations will actually benefit the public. However, it is often the case that the people who ultimately pay for the research, the taxpayers, do not have access to the research upon which a proposed government regulation based. As a result, it is difficult for individuals and other private interests to confirm or verify the science and research data the federal government uses to draft regulations. Without such data, any potential challenge to a proposed regulation is extremely difficult.
What is the Shelby Provision? The fiscal year 1999 Omnibus Appropriations Act contained a sunshine-in-government provision — known as the Shelby provision — that would allow access to federally funded scientific data used to support regulations that have an impact on the economy and the health of all Americans. Specifically, the Shelby provision requires the Director of OMB to amend Section _.36 of OMB Circular A-110 "to require Federal awarding agencies to ensure that all data produced under an award will be made available through the procedures established under the Freedom of Information Act."1
Why is Data Access Needed? The federal government funds a significant portion of all the research conducted in the United States. The results of this research often serve as the basis for decisions that effect almost every aspect of daily life — from social and economic policy decisions concerning education, taxes, crime, and drugs; to environmental, health and safety regulations. Without access to the raw data from government-funded research, the public is severely limited in its ability to understand the basis of a proposed rule or the validity of decisions made by government. Under the new law, the public would have the ability to challenge the regulating agency based on the facts and research, not just the conclusions of that research or the information the agency elects to include in the public record.
Exhibit A: The EPA. A case in point is the Environmental Protection Agency (EPA). In July 1997, EPA issued new air quality regulations designed to reduce levels of atmospheric ozone and fine particulates. The agency, however, was never able to make a compelling public-health case to support issuing the new rules. Despite repeated requests from individuals, Congress and other outside groups for access to the so-called "Six Cities" study, EPA refused to release the data. On May 14, 1999, a U.S. appeals court overturned the new standards for what it concluded was an unconstitutional delegation of legislative power. The unconstitutionality ruling was based in part on the EPA’s inability to articulate the "intelligible principle" upon which the rules were based. In other words, the agency had no real scientific data to prove the new rules would actually be beneficial to the public. EPA’s standard for soot and other airborne particles was, therefore, ruled "arbitrary and capricious."
Data Access Aids Good Rulemaking. Full disclosure of the published research data used in the rulemaking process is essential to accountability and external quality review. We are seldom certain that the results of a given study are valid without outside testing or corroboration. In the case of EPA’s proposed changes to the National Ambient Air Quality Standards (NAAQS), further investigation of the data in the two studies underlying EPA’s could have helped determine the actual exposure levels to the two pollutants and the impact of potential confounding variables — for example, extraneous health factors such as smoking or respiratory disease. A scientific challenge to the rules based on total access to the underlying data during the public comment period could have prevented their promulgation and precluded the need to waste millions of taxpayer dollars in a court case over their necessity.
Invasion of Privacy? Concerns have been raised by some in the scientific and medical communities about the viability of federally funded medical research and the privacy of personal medical information that may be part of that research. Such concerns are, in fact, baseless. Under the Freedom of Information Act (FOIA), federally funded research data that falls under any of nine specific categories — including trade secrets and privileged or confidential information — are clearly exempt from public release.
The FOIA provisions are specifically intended to protect the medical privacy of individuals and to protect proprietary research. The FOIA’s exemption (b) (6) provides for the protection of "personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy." Exemption (b) (4) withholds "trade secrets and commercial or financial information" from disclosure.2 The Shelby amendment, further, gives the granting agency total discretion in defining what constitutes "data," and in determining the applicability of FOIA exemptions.
Conclusion. It is only fair in a democracy that the taxpayers who fund this research have a chance to review it to ensure that their money is being well spent, and that the freedoms they must often sacrifice for the sake of new regulations are worth the benefits. In the past, certain government agencies have relied upon the results of research where analysis and underlying data have not been available for public scrutiny. The implementation of the Shelby provision will help improve both the transparency of government and the effectiveness of government regulation.
1Office of Management and Budget. Notice of Proposed Revision to OMB Circular A-110, Uniform Administrative Requirement for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations, 2/4/99.
2Freedom of Information Act