Washington

US government agencies are scrambling to craft policies that will guarantee the quality of the data they produce, in compliance with a little-noticed law that was passed over a year ago.

The White House Office of Management and Budget (OMB) has given government agencies until 1 May to come up with guidelines for how they will implement the law, which many observers say will make it easier for industry and other affected groups to challenge federal regulations on scientific grounds.

Even though the new law (Public Law 106-554) does not come into force until October, the industry-backed Center for Regulatory Effectiveness (CRE) has already invoked it. The centre asked the White House science office to stop disseminating the National Climate Assessment, which synthesizes scientific thinking about the consequences of climate change, on the grounds that it relies on “inaccurate” computer models.

The CRE, whose advisory board includes several former OMB officials, helped to draft the data-quality provision of the law, a mammoth spending bill covering many agencies that moved through Congress just before Christmas 2000.

The law directs agencies to find procedures for “ensuring and maximizing the quality, objectivity, utility, and integrity of information” that they disseminate, and to come up with mechanisms allowing “affected persons to seek and obtain correction” of such information where necessary.

A wide range of information published by the government may be affected by the law, including lists of endangered species and research that supports the regulation of pollutants, such as arsenic or airborne soot. All will now have to meet new standards set by each agency as to what constitutes “quality” research.

In the year since the law was passed, the OMB has published draft guidelines that question whether peer review is, in itself, sufficient to guarantee quality. The OMB originally argued that it was not, citing “cases where flawed science has been published in respected journals”.

In some cases, the OMB said, results must be “substantially reproducible” to pass muster. That raised eyebrows in some quarters, such as the National Academy of Sciences, whose president Bruce Alberts wrote in a public comment that reproducibility sets a “new and unreasonable standard” for disseminating scientific information.

The OMB backed off, but not entirely: “It is not OMB's intent that each agency must reproduce each analytic result before it is disseminated,” the agency said in its final guidelines last month. But the data and methods used should be transparent enough for someone else to reproduce them.

Researchers fear that the law will be used unscrupulously by opponents of regulation to challenge findings, in disciplines such as climate or ecology, that may be difficult to replicate independently, as in cases where the opportunity to collect fresh data has passed.

Each agency is responsible for coming up with its own procedures for guaranteeing data quality and handling complaints. Jim Tozzi, a Washington-based regulatory consultant and CRE adviser, who signed the letter requesting the withdrawal of the National Climate Assessment, thinks the burden of proof will be on challengers.

“You have to have real data” to make a challenge, Tozzi says. But he predicts that if petitioners are not satisfied by an agency's response, disputes will end up in the courts.

Most federal agencies are still feeling their way to understanding the full implications of the law, according to Tozzi and others. The Environmental Protection Agency declined to comment on how it would draft its policies, and the White House science office, which received the CRE's complaint about the National Climate Assessment, says it is referring the matter to White House lawyers.

But at the Environmental Protection Agency and elsewhere, the level of concern is rising as the May deadline nears. The agency is inviting public comments online on the subject this week, when the National Academy of Sciences will also hold the first of a series of workshops on the law's implications.

→ http://www.whitehouse.gov/omb/fedreg/reproducible.html