The federal government recently proposed extensive new peer-review procedures
for scientific reports from regulatory agencies. While some agencies already
practice peer review with their scientific documents, these are the first government-wide
mandated standards, and they have some people crying foul.
Published in the Sept. 15 Federal Register, the White House Office of Management and Budgets (OMB) Office of Information and Regulatory Affairs (OIRA) proposed a standardized process in which all significant regulatory science documents must go through mandatory external peer review in order to alleviate potential conflicts of interest.
The goal is fewer lawsuits and a more consistent, competent and credible regulatory environment, said John Graham, OIRA administrator, in a press release. Each agency will have to report annually to OIRA on the documents it expects to issue over the coming year. This report must include a plan for external peer reviews, including disclosure of the peer-review panelists.
|The goal is fewer lawsuits and a more consistent, competent and credible regulatory environment.|
Some groups, such as the Center for Regulatory Effectiveness (CRE), have quickly
endorsed the new standards. But CRE has taken it a step further, saying that
the plan will require university and other non-federal researchers to adhere
to the same standards. CRE describes itself as an independent organization that
provides Congress and OMB with methods to improve the federal regulatory process.
Thomas McGarity, president of the Center for Progressive Regulation (a nonprofit
research and educational organization), called CREs claim a blatant
attempt to bully university scientists, in a letter to Graham. At most,
McGarity said, the new standards place an obligation on each agency to ensure
that any data it winds up disseminating or using passes muster under the Data
The Data Quality Act is the law enacted in 2001 to attempt to ensure that federal agencies use and disseminate accurate information. The new standards are OIRAs attempt to further define the act.
The proposed set of standards concerns review of technical information released by federal agencies in a way that indicates official endorsement of the information by the government, says Garrette Silverman, an OMB spokesman. Scientists within universities and industry are not directly covered by the standards, he says. The new rules do not, he adds, seek to modify or influence the peer review practices of scientific journals. The proposed standards cover the dissemination of scientific information by administrative agencies and thus apply only to research conducted by federally employed scientists or grantees.
They apply to scientific or technical information that is relevant to regulatory policies and qualifies as influential under OMBs information quality guidelines. Thus, the standards do not apply to most of the research funded by the National Institutes of Health and the National Science Foundation. To conserve resources, OMB will allow agencies to tailor the intensity of the peer review process to the importance of a document. And peer review of information in a respected scientific journal can satisfy the requirement for the document.
CRE, it seems, has overstepped its bounds, says Jane Buck, president of the American Association of University Professors.
We believe that the peer review process works really well, she says. But its hard to predict how proposals that havent taken effect yet might affect individuals. The amount of paperwork involved is already burdensome, Buck adds, so they would oppose anything that would result in a lot of additional paperwork. The associations government relations committee will meet later this month to discuss the standards further and assess potential impacts. But as long as the government doesnt try to extend its standards to academia, there shouldnt be a problem, Buck says.
In the meantime, scientists within the geoscience community also do not see the new standards directly affecting them. Robert Hirsch, associate director for water at the U.S. Geological Survey (USGS), says that they dont anticipate a large impact. But I think its very early in the game and we dont know how it will all play out, he says. Hirsch also points out that most of the important documents that come out of the geoscience community related to regulation are already extensively peer-reviewed.
Groups linked to industry have hailed the new standards; in addition to ordinary peer review, even further review could be called for if a reports findings would cost industry more than $100 million to change its policies. Proponents also say it will raise the quality of federal rulemaking and lower the chances that rules will be overturned in court.
Opponents, however, warn that the standards could paralyze new regulations, especially on issues such as global warming, or air or water pollution, where the risks and benefits are complex, politically charged and potentially costly.
Not so, Silverman says: In the long run, peer review will strengthen regulations to protect health, safety and the environment by making these rules less vulnerable to political and legal attacks.
The standards will be modified as appropriate following a public comment period that ends Dec. 15 and a formal interagency review; the final standards likely will be issued in spring 2004.
Federal Register document on government peer review, in PDF format, Sept. 15, 2003