Law Revises Standards for Scientific Study


            March 21, 2002



            Law Revises Standards for Scientific Study

            By ANDREW C. REVKIN

            t does not even take effect until next Oct. 1. But a little-noticed

            law called the Data Quality Act, signed in the waning days of the

            Clinton administration, has set off a fierce debate over how best to

            weigh health and environmental risks.

            The law — supported, and largely written, by industry-backed groups

            — requires the government for the first time to set standards for

            the quality of scientific information and statistics used and

            disseminated by federal agencies. It would create a system in every

            government agency under which anyone could point out errors in

            documents and regulations.

            If the complaints were borne out, the agency would have to expunge

            the data from government Web sites and publications. More broadly,

            opponents of the new law say that while nobody wants the government

            to issue flawed data, the new process could undermine valid

            regulations and stifle government efforts to convey information on

            issues like climate change and cancer risks.

            The National Academy of Sciences is convening a meeting today at

            which officials from government regulatory agencies, lawyers and

            experts from industry, science and environmental groups will discuss

            the law's potential for harm and good.


            Even before the law takes effect, one of the groups that helped

            write it has already cited it in a petition requesting the

            withdrawal of a report on global warming.

            The group, the Center for Regulatory Effectiveness, said in a Feb.

            11 letter to the White House Office of Science and Technology Policy

            that a government assessment of the regional impacts of climate

            change is alarmist and based on flawed computer models.

            If the center prevails, the study — the product of 10 years of work

            and critiques by independent scientists — could be removed from

            government Web sites and files. Many climate scientists, even some

            whose criticisms of early drafts were quoted in the center's

            petition, say the challenge is unfounded.

            The Data Quality Act was quietly enacted in December 2000 as 27

            lines in a giant budget bill.

            It charged the government to create procedures "ensuring and

            maximizing the quality, objectivity, utility and integrity" of

            scientific information and statistics disseminated by federal

            agencies. Now, dozens of government agencies are struggling to

            translate that language into thousands of pages of quality-control


            Agencies must finish drafts of their science quality procedures by

            May 1 and send the final version to the White House Office of

            Management and Budget by July, where the Bush administration will

            check to be sure guidelines meet its standards.

            The effort is being overseen by Dr. John D. Graham, an expert on

            risk and regulation from Harvard who last year became the

            administrator of the office of information and regulatory affairs of

            the Office of Management and Budget. Dr. Graham's focus on using

            strict statistical analysis of risks and benefits to judge where to

            focus public resources has made him a favorite of industry and a

            target of private environmental groups, which often rely on public

            passion to drive campaigns.

            He said that the administration's goal was to ensure that all

            government agencies — in every duty — consider not just the quality

            of the data they use and communicate, but also the quality of their

            own analysis.

            The result, he said, is that "in the long run this will focus

            government on problems that science suggests are very serious and

            away from problems that are less serious."

            The prospect has industry officials elated. Many of those who helped

            draft the measure defend it as a vital breakthrough in their

            years-long effort to pinpoint weaknesses in the science behind

            costly regulations.

            "This is the biggest sleeper there is in the regulatory area and

            will have an impact so far beyond anything people can imagine," said

            William L. Kovacs, the vice president for environment, technology

            and regulatory affairs of the United States Chamber of Commerce.

            "This is the first time where, if the data is not good, you can

            actually begin challenging the agency," Mr. Kovacs said. The law, by

            setting a government standard for scientific quality, could also

            help industry prevail in lawsuits claiming rules relied on poor data

            or analysis, he and other industry representatives say.

            A prime target, he and other industry representatives said, is new

            Environmental Protection Agency rules restricting the finest

            pollution particles, which are mainly emitted by diesel engines and

            power plants and have been linked increasingly to lung and heart


            Many industry officials say the rule is too broad and the E.P.A.

            should first find which types of small particles are hazardous.

            Supporters of the regulations, which have not yet taken effect, say

            it would take years of additional study to pinpoint the exact

            hazard, but people are dying from such pollution now.

            Senator James M. Jeffords, the Vermont independent who is chairman

            of the Senate environment committee, said the goal of the law is

            laudable, but it could easily work against effective government.

            "Opponents of government action to protect the public's health and

            the environment," Mr. Jeffords said, "have latched on to the Data

            Quality Act and are attempting to misuse it to prevent the public

            from getting valid information about threats to their well being and

            quality of life."

            Following guidelines written by the Bush administration, government

            agencies are creating procedures for judging the quality of the data

            they use — whether generated within the government or by university

            scientists, hospital researchers, companies or private groups.

            The more influential the data are likely to be, the higher the

            quality standard they must meet, the guidelines say. In some cases,

            the guidelines state, even studies published in respected

            peer-reviewed journals will require further confirmation.

            Under the data law, by October every agency must have the equivalent

            of a complaints line, through which individuals, companies or groups

            can challenge scientific findings.

            The Environmental Protection Agency on Tuesday initiated a four-day

            online comment process on its Web site,, seeking

            ideas for how it might best create such a system.

            Some scientific groups are concerned that insufficient attention has

            been paid to the new regulation and its likely effects.

            "This is a critical juncture," said Joanne Padrón-Carney, director

            of the Center for Science, Technology, and Congress of the American

            Association for the Advancement of Science, the world's largest

            scientific organization. "Each agency will be clarifying its own

            methods for how they define things like quality. It's important for

            scientists to pay close attention."

            Ms. Carney said there was potential for problems if industries or

            institutions opposed to certain regulations demanded complicated,

            time-consuming, intrusive reviews of data.

            "We really would not like to have science attacked as a way of being

            sure that policy isn't made," she said.

            Views remain mixed on whether the benefits of the law will outweigh

            the potential harm.

            Alan B. Morrison, a lawyer on leave from Public Citizen, the private

            consumer watchdog group in Washington, said the law could provide

            unexpected opportunities for critics of any government agency — from

            the Defense Department to the Nuclear Regulatory Commission.

            It applies just as much to data released by the Pentagon as it does

            to E.P.A. pollution studies, Mr. Morrison noted.

            But over all, he said, he is convinced that "its clear purpose is to

            slow agencies down."

            Many experts on regulations say that if the guidelines are written

            appropriately, they could spur agencies to carefully, openly review

            the quality of science used to write rules or set policies in


            Currently, in most cases, a pollution or health standard is

            published and only then the fighting begins over whether it is valid

            or not, said Frederick R. Anderson, a corporate lawyer in Washington

            who is part of the National Academy of Sciences panel conducting the

            meeting today.

            Often, such fights spill over into the courts, resulting in years of

            costly litigation.

            Dr. Graham said he expected that the guidelines, instead of

            burdening agencies with new costs and work, would reduce the burden

            by cutting the number of such lawsuits.

            But some architects of the legislation say they expect it will help

            them in the courtroom. Most notable is James J. Tozzi, the founder

            of the Center for Regulatory Effectiveness.

            With a government-set yardstick for quality, Mr. Tozzi said, critics

            of regulations can now build more convincing cases showing that an

            agency was arbitrary and capricious in its choice of data. Until

            now, such suits have generally failed.

            The most important aspect of the law, he said, is that it creates a

            consistent system for uncovering errors early and encouraging

            agencies to be more careful about how they use data.

            "It's the information age," Mr. Tozzi said. "Now in the world's most

            powerful government you're going to have to issue information that's



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