Debating Shelby

Sentiments expressed at a March 12 National Academy of Sciences workshop suggest that scientists and policy-makers remain very concerned about data access issues related to the now infamous Shelby Amendment. The amendment, a two-line provision added by Sen. Richard Shelby (R-Ala.) to an omnibus appropriations law for fiscal year 1999, subjects federally funded scientific research to requests for data made under the Freedom of Information Act (FOIA).1 Its inclusion sparked a debate between industry stakeholders and scientists. The former endorsed the amendment as a means of challenging scientific studies that support costly regulations; the latter expressed concerns about increased paperwork, intellectual property searches by industry and academic competitors, unwarranted access to personal information on research subjects, and even deliberate use of the amendment by industry to reinterpret data and harass researchers. After receiving thousands of public comments, the Office of Management and Budget (OMB) reinterpreted the amendment, reaffirming FOIA's privacy trade and secrecy protections, and limiting requested data to published or cited research used by the federal government in developing legally binding agency actions. Thus far, the legislation has not been extensively tested. The National Institutes of Health has granted only four FOIA requests and denied three. The Environmental Protection Agency has received only a handful of requests. Many scientists and scientific institutions, including both the NAS and the Federation of American Societies for Experimental Biology, saw the OMB's interpretation as a big improvement. Several panelists at the NAS workshop approved as well, but they expressed continued concern. Workshop attendee E. William Colgazier, CEO of the NAS and the National Research Council, was hoping the OMB agreement would be acceptable to all interested parties. But after hearing discussion at the workshop, he called his outlook "less sanguine." NAS director Bruce Alberts said he understood the importance of openness in science, but he called FOIA an inappropriate tool for gaining that access. He worries that anybody can request data as a result of the Shelby amendment--that there's no "need to know" provision. He's particularly concerned that tobacco companies or organizations like the People for the Ethical Treatment of Animals (PETA) will soon use FOIA to harass researchers. David G. Hawkins, director of the Air and Energy Program at the Natural Resources Defense Council, said his principle objection was Shelby's applying to only government-funded, and not privately supported, research. Organizations like his, said Hawkins, can't use FOIA to question data presented by industry, though industry can question the underlying data of federally funded research. The U.S. Chamber of Commerce has been among the most outspoken supporters of the original Shelby amendment and critics of the OMB revision. "The bottom line is that the data that needs to be shared is the data that is part of public policy, the data that actually imposes costs," said William L. Kovacs, vice president of environment, technology, and regulatory affairs at the organization. He claims that the 4,000 new industry regulations established annually cost the U.S. economy $725 billion. Kovacs is primarily concerned about the regulatory impact of studies like a Harvard University-led pollution study that was undertaken to measure the morbidity and mortality effects of particulate matter in six U.S. cities. Dubbed the "six-city study," it was a big reason for Shelby introducing his amendment. Controlling for age, weight, occupation, education, and other factors, researchers found that the Northeast cities nearest to coal-burning plants had higher mortality rates. Started in 1973, and continuing for more than two decades, the study was crucial to the EPA's tightening of ambient air quality standards. After business interests were denied access to the study's medical data (researchers cited concerns about the anonymity of the subjects involved), Harvard researchers enlisted an independent, nonprofit corporation called the Health Effects Institute (HEI) to do a data audit. HEI backed the data and the findings. Kovacs said that the Chamber of Commerce remains dissatisfied and continues to insist on seeing the data. At the workshop, when asked by David Korn, senior vice president for biomedical and health sciences research at the Association of American Medical Colleges, what the U.S. Chamber would do with the data if they had it in hand, Kovacs suggested they'd have a team "reevaluate it." "And then what?" asked Korn. Kovacs gave no specifics. Regardless, he implied that a lawsuit challenging the OMB interpretation was a good possibility. More controversy could be looming with another, lesser-known amendment referred to as the "daughter of Shelby" by Jim J. Tozzi, a member of the board of advisers at the Center for Regulatory Effectiveness. Also passed as part of an omnibus spending bill, this "data quality" amendment says that the OMB must issue regulations that define minimum thresholds of data quality disseminated by the federal government, and regulations that allow any outside party to petition the government for changing that data. According to Tozzi, the amendment requires that data that researchers are presenting to the government, to be used by the government, go through a "quality sieve." Eugene Russo can be contacted at erusso@the-scientist.com. 1. N. Halim, "A data access conundrum," The Scientist, 14[6]:13, Mar. 20, 2000.

Debating Shelby

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