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Interactive Public Docket

COMMENT BY: Daniel M. Byrd III, Ph.D., D.A.B.T. President, Consultants in Toxicology, Risk Assessment and Product Safety

DATE:August 16, 1999

Mr. Charles J. Fromm
Executive Director
Center for Regulatory Effectiveness
11 Dupont Circle, NW, Suite 700
Washington, DC 20036

The World Conference on Science recently met in Budapest under the auspices of UNESCO. On July 2, 1999, the delegates approved a Declaration on Science and the Use of Scientific Knowledge. The preamble recognizes "... the importance for scientific research and education of full and open access to information and data belonging to the public domain." The conclusions acknowledge that "... the social responsibility of scientists requires that they maintain high standards of scientific integrity and quality control, share their knowledge, communicate with the public and educate the younger generation. Political authorities should respect such action by scientists." To me, this principle seems a truism, something all scientists would embrace.

Right now, federal grant recipients send reports to their funding agencies that often consist of little more than the publications based on the funding. The absence of the data supporting the conclusions in these publications is the very essence of the problem that the Shelby amendment seeks to solve. Data availability is very inconsistent among different scientific areas. Usually, supporting information is readily available in physics and chemistry but not so in the biological sciences, particularly epidemiology.

To the great embarrassment of scientists seeking to improve the application of the Shelby amendment, many academic opponents apparently did not bother reading existing Freedom of Information Act (FOIA) restrictions, which protect a wide range of data, including the national defense, foreign policy, internal personnel rules and practices, trade secrets, confidential commercial or financial information, internal memoranda, unwarranted invasions of privacy, law enforcement, regulation or supervision of financial institutions, and geophysical or geological information, such as maps. To the contrary, the opposition has pushed the rhetoric, "too blunt an instrument," without offering a meaningful alternative. Because the federal agencies have experience with FOIA, the opponents might have pointed to past examples where disclosure of federal data created problems. Instead, the examples have been hypothetical, usually about subjects exactly where FOIA does shield disclosure, such as confidential clinical research data or proprietary commercial data. Nothing in the law requires making preliminary data available to the public. These speculations diverted attention from substantive technical problems in A110, which we could solve, such as defining "data," creating mechanisms to compensate the universities, and explaining how a recipient institution should supply data generated by investigators that are no longer under its control.

The provision of federal research support is not a one-way process. The scientific community asks the public for research funding, not for the sake of the scientists' welfare, but to serve the public interest. Basic research in the U.S. primarily relies on federal grants. In the past, this funding has produced magnificent results, dividends that have more than repaid the public investment.

Anyone like me, who depends on scientific progress for a living, will want to sustain, if not increase, federal funding of research. To do so, we must maintain the public's trust. The public believes scientists when they say that the process requires open access and shared data, barring such exceptions as privacy and property. Not only will the public balk at funding an enterprise that produces data the public cannot obtain, the very existence of such a system will not make sense. Instead, the public will understand the current opposition of the academic community to the Shelby amendment as hypocritical. Inevitably, confidence in the scientific enterprise will erode.

Sincerely,

Daniel M. Byrd III, Ph.D., D.A.B.T.
President, Consultants in Toxicology, Risk Assessment and Product Safety
Washington, DC