Thursday, August 30, 2007

Activist Report Calls For Data Quality Reforms, Congressional Oversight

A new report from the activist group OMB Watch calls for reforms in the way federal agencies are implementing the Data Quality Act (DQA) and for Congress to conduct oversight investigations into how the law has been enforced, arguing the measure has given industry a tool to delay and challenge risk research that could lead to stricter health regulations.  

During intense legislative debates over risk assessment and cost-benefit analysis in the 1990s, demands by industry and congressional reformers focused significantly on the need to ensure that regulatory decisions were based on what they called “sound science” and quality data. Ultimately the DQA was passed by quietly inserting it into a spending bill passed in 2001 rather than as part of risk reform legislation, which proved difficult to move through Congress.

The Aug. 28 report, An Attack on Cancer Research: Industry’s Obstruction of the National Toxicology Program, points to what OMB Watch says is the disproportionate number of industry DQA challenges to the quality of information publicized by the National Toxicology Program (NTP). Industry has particularly targeted the NTP’s biennial Report on Carcinogens (RoC), OMB Watch says, citing that fact as evidence that the law is being used primarily to undermine the release of needed public health data.

The RoC was first ordered by Congress in 1978 and is released by NTP every other year as an index of “agents, substances, mixtures, or exposure circumstances that may pose a hazard to human health by virtue of their carcinogenicity,” according to the report's NTP Web site. The report includes data on substances' carcinogenicity and genotoxicity and the potential for human exposure to these substances. It also describes existing federal regulations to limit exposures.

Including a substance in the report can have major regulatory ramifications, especially in California where state law mandates the labeling of substances if they occur in any product above a concentration that poses an “unreasonable risk.” The OMB Watch report points out that the American Chemistry Council (ACC), a chemical industry trade group, has itself cited the commercial impact of listing in the RoC. In a 2003 DQA challenge to the National Institutes of Health (NIH), the ACC compared being listed in the RoC to a “stigma [that] can and often does lead to product liability claims, diminished sales, product substitution by downstream users of the substance, and related commercial damage.”

Congress should examine whether the DQA is being abused to prevent such regulatory steps, the new report says.  “Congress needs to conduct oversight on the use of the law and clarify and limit the scope of DQA,” the report says, adding, “changes are needed at the legislative level to fix the DQA statute by restricting its use and clarifying its scope.”

The DQA requires EPA and other federal agencies to accept and respond to petitions to correct allegedly flawed data used in rulemakings and other decisions. The White House Office of Management & Budget (OMB) has issued guidelines on how agencies should implement the law, and has faced its own share of activist criticism, particularly under former regulatory affairs chief John Graham. Activist and some academic experts have charged that OMB has an antipathy to strong EPA standards and hostility to research that suggests such standards might be necessary to protect public health.

For instance, the OMB Watch report points to a 2004 letter from Graham to NIH Director Elias Zerhouni, which “stated that Graham was motivated to recommend revisions to NTP’s 'already rigorous process of scientific deliberation'” because of what were then six information quality correction requests related to either the RoC or to the NTP review process for individual substances. NTP incorporated many of Graham’s recommendations in proposed revisions to the RoC review procedures, which were finalized last April. According to the report, “This resulted in the delay of the review of the 12th RoC for over a year.” A source with the National Institute of Environmental Health Sciences (NIEHS), NTP's parent organization, says the RoC has still not been released, and the NTP Web site describing RoC substance review procedures has not been updated since April.

More broadly, the DQA has become a favorite industry tool to impede health research rather than correct mistakes for public benefit, the report argues. Each of the 10 DQA challenges to NTP information law to date has been “made by companies or industry-affiliated organizations, even though the audience for NTP’s information is considerably broader, including environmental groups, the research community and public health agencies,” the report says.

The law’s worst impact has been to demand large amounts of time and expertise that should not be devoted to responding to unwarranted challenges, the report says. “DQA challenges often divert time and resources away from the work of studying carcinogenic chemicals. The same likely holds true in other agencies, where challenges divert the time and resources of scientists, economists, statisticians and other experts who work to protect public health and safety,” the report says.

Rather than spending hours or days responding to each DQA petition, the report recommends, agencies should “dismiss DQA challenges covered by existing information quality procedures,” such as public review and comment. They should also “only consider challenges of substantive information” and should “distinguish between fact and policy.” In addition, they should ignore challenges to policy decisions as outside the law's scope and should ensure that responding to challenges will not delay agency action, potentially waiting to respond to challenges until after major regulations or reports are released, the report suggests.

The NIEHS source says the DQA “has been a thorn in the staff's side, no doubt about it. Interactions with OMB increased substantially after it passed.”

An OMB Watch source says the odds of agencies implementing the recommendations at this time are “fairly minimal,” but suggests that “with a change of agency heads” -- especially after the 2008 presidential election -- “this could give [agencies] a roadmap” for potential reforms. The source also points out that whether or not agencies immediately change how they respond to DQA challenges, Rep. Henry Waxman (D-CA), who chairs the House oversight committee, has expressed interest in studying the DQA's impacts on federal agencies, requesting a report on the issue from the Government Accountability Office last year.

If Waxman or another lawmaker decides to pursue oversight, “it needs to be beyond DQA to how to ensure data quality” at federal agencies, the source says. “The law doesn't adequately ensure that, and a congressional effort to change the law will need a great deal of education. . . . You need to lay groundwork.”

Waxman's office could not be reached for comment by press time. -- Adam Sarvana


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