Shelby Amendment

Introduction

In the late 1990's, proponents of government transparency made several attempts to increase public access to federally-funded scientific data. The impetus for this movement arose largely from the private sector's frustration over the inaccessibility of data used to support regulations, best exemplified by the controversy surrounding the 1997 Environmental Protection Agency (EPA) air pollution standards.¹ Sympathetic policy makers claimed that, considering the financial burden they were often asked to impose on businesses, they deserved a chance to inspect the data underlying controversial regulations. Scientists and academic institutions warned that while increasing openness was a valid aim, the privacy of research subjects and the preservation of scientific autonomy should be paramount.

The Shelby Amendment

Inserted in the Treasury, General Government, and Civil section of Fiscal Year (FY) 1999's Omnibus Appropriations Bill (Public Law 105-277) was a provision to change a federal regulation in order to allow broader access to federally-funded research data. The provision, called the Shelby Amendment after its sponsor, tasks the Office of Management and Budget (OMB) to change OMB Circular A-110 so that all federally-funded research data can be accessed through the mechanisms set forth in the Freedom of Information Act (FOIA).

The provision reads:

"Provided further, That the Director of OMB amends 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 to the public through the procedures established under the Freedom of Information Act."

The bill was passed by Congress and signed by the President, but many groups complained about the lack of debate on the measure and the secrecy under which it was proposed.² The office of Senator Richard Shelby (R-AL), however, pointed to the related colloquies that had been held on the Senate floor, and noted that similar legislation had been proposed several times before.³ Still, many opponents of the Amendment bemoaned the lack of substantive debate on such an important topic, and launched a fight to overturn the provision, among them Rep. George Brown, Jr. (D-CA) who unsuccessfully tried to repeal the provision.⁴

Proposed Revision of A-110

OMB subsequently filed a proposed revision in the Federal Register on February 4, 1999 and allowed for a 60-day public comment period before taking further action. OMB's proposed revision focused exclusively on published research used to support federal regulations. It read:

"Pursuant to the direction of Pub. L. 105-277, OMB hereby proposes to amend Section __.36 of OMB Circular A-110 to read as follows: (c) The Federal Government has the right to (1) obtain, reproduce, publish, or otherwise use the data first produced under an award, and (2) authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes. In addition, in response to a Freedom of Information Act (FOIA) request for data relating to published research findings produced under an award that were used by the Federal Government in developing policy or rules, the Federal awarding agency shall, within a reasonable time, obtain the requested data so that they can be made available to the public through the procedures established under the FOIA. If the Federal awarding agency obtains the data solely in response to a FOIA request, the agency may charge the requester a reasonable fee equaling the full incremental cost of obtaining the data."

Public Response to the Proposed Revision

OMB received over 9,000 comments on its proposed revision, with 55 percent of the respondents favoring the changes.⁵ Some heralded the move as a boon to the economy, claiming that it would help to "avoid situations in which data that cannot withstand vigorous scrutiny is used to support new regulation."⁶ According to the U.S. Chamber of Commerce, a pro-business group, the new provision would provide "a basis for the bureaucracy imposing $700 billion in annual regulatory costs..."⁷

Many supporters outside of industry praised the revision for allowing taxpayers to view directly the research they themselves subsidize.⁸ Some comments even included stories of past frustrations over the inaccessibility of data. The Salt Institute, for example, described a hard-fought battle over the accuracy of a government-funded study on nutrition.⁹ Still, many of the supporters complained about the narrow scope of the provision, favoring applicability to all government-funded research, not just published regulatory data.¹⁰

Scientific and academic organizations took a strong stance against the new rules. While for the most part, they appreciated the restriction of the changes to published regulatory data,¹¹ they raised a number of concerns both about the Shelby Amendment and the vague language in the A-110 revision. They felt that by not effectively defining the terms "data" and "published" OMB had opened the door to a number of potential problems.

Several groups worried about the premature release of data and its potentially harmful consequences. In controversial studies, data released too early could allow interested parties to thwart potential regulation by harassing and intimidating scientists.¹²

The revision left some respondents concerned about collaborative research between federally-funded institutions and the private sector. They worried about unintended consequences on the Bayh-Dole Act, which awards patent rights to universities and businesses over federally-funded research. Release of data might jeopardize intellectual property protection and thus hamper public-private collaboration.¹³

Other criticisms of the revision focused on human research subject confidentiality.¹⁴ Some groups felt that "�compulsory premature disclosure of data could discourage the participation, or alter the behavior, of study participants, thereby jeopardizing important research�"¹⁵ Critics feared that if people suspected their personal medical information could be accessed by the public, they might not participate in the first place.

Another pragmatic complaint concerned the lack of specifics with regard to reimbursement mechanisms. The American Lung Association expressed anxiety that "much of the burden related to FOIA requests will be passed on to grantees, who have no ability to recoup the costs."¹⁶

Finally, a theme that appeared in many comments was the assertion that the FOIA procedure was an inappropriate mechanism to share research data. According to Rep. George Brown, "OMB's revision would eliminate the distinction between a grant and a contract. A grant is provided to support an activity we deem to be in the public interest; a contract is used for procurement."¹⁷

Second Revision to A-110

OMB released its second proposal on August 11, 1999 in the Federal Register. The proposal addressed the concerns of vagueness raised in many of the comments and attempted to improve the definitions of key terms.

"Research Data" was limited to recorded material and made to exclude preliminary analyses, trade secrets, copyrighted or patented material, and drafts of scientific papers. In addition, the FOIA exemption used to protect personal medical files was added to the provision.

The term "Published" was redefined so as to include material published in a peer-reviewed journal or cited by a Federal agency. The scope of the revision was limited to citations that actually supported federal regulations; guidelines and memos were excluded.

OMB also sought comments on a plan to restrict the proposal to regulations costing over $100 million. Finally, the proposal called for estimates on reimbursement costs and ideas for potential reimbursement mechanisms.

Final Revision to A-110

After receiving more than 3000 comments, OMB posted the final revision of Circular A-110 in the Federal Register on October 8, 1999.

OMB offered additional modifications to some key terms in order to address issues such as intellectual property rights. A three year data retention requirement for federally-funded scientists was set, but the concept of a $100 million impact threshold was removed.

After reviewing several suggestions, OMB detailed a reimbursement plan in which a Federal agency would serve as the middleman between the FOIA requester and the data provider.

The revised A-110 Circular became effective November 6, 1999.