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 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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