Learning to Love the Data Quality Act

At the very end of the Clinton Administration, Republican Congresswoman JoAnne Emerson inserted a two-paragraph provision into the 2001 Treasury and General Government Appropriations Act. These paragraphs would become known as the Data Quality Act (as well as the Information Quality Act) and its passage represented a major victory for industries – including the tobacco and chemical industries – regulated by the federal government.

The law requires federal agencies to create procedures to ensure the “quality, objectivity, utility, and integrity” of scientific information to be disseminated. It also requires the agencies to have an administrative mechanism to review and respond to data-related complaints from the public.

The champion and author of the Data Quality Act was Jim Tozzi, a former official in the Office of Management and Budget (OMB), who led an organization called the Center for Regulatory Effectiveness. “There’s no doubt that we were funded by industry,” Tozzi later said. Tozzi and his industry clients envisioned using the complaint process under the new law to slow down or stop regulations across the whole of the federal government.

And indeed, they would try – and sometimes succeed – in leading agencies to make changes to their scientific findings and communications. But, under the Trump Administration, the law deserves a second look. The Data Quality Act is now a potential tool for the public health and scientific communities to raise awareness, slow down, and possibly even block policy based on insufficient or misleading information.

In the years after its passage, OMB issued guidance about the implementation of the Data Quality Act . The guidance noted that, under the law, “it is clear that agencies should not disseminate substantive information that does not meet a basic level of quality.” It called upon federal agencies to develop protocols for data quality and to “make their methods transparent.”

The Department of Health and Human Services (HHS) followed up with detailed instructions explaining the steps used to produce the best possible science. In an overview section of its “information quality” website, HHS states that “scientific financial, and statistical information used in support of regulatory decision-making is subject to a quality review process within the agency involving appropriate experts depending upon the nature of the information.”

The site then provides each agency’s specific commitments under the Data Quality Act. The Centers for Disease Control and Prevention (CDC) vows that even “oral information, including speeches, interviews, and expert opinions” will be “accurate, reliable and unbiased” because of “existing review and clearance procedures.”

For its part, the US Food and Drug Administration pledges to treat “information quality as integral to every step of the development of information, including its creation, collection, maintenance, and dissemination.” The agency has special procedures for risk assessment that include using “the best available peer reviewed science and supporting studies” and presenting information about risk in a way that is “comprehensible, informative, and understandable.”

Over the first 25 years of the Data Quality Act, HHS received just 81 complaints – calling for changes to information on fluoride, tanning beds, trans fats, and defibrillator training, among other topics. In some cases, agencies made corrections to the information; in other cases, they explained why no changes were needed. Fears that that the law would stymie the regulatory process altogether proved to be unfounded.

OMB officials have attributed the relatively small number of data-related complaints to the fact that the agency gets the final word under the law; there’s no option to appeal to the courts. Yet, that’s just part of the story. OMB asks agencies to review concerns and respond publicly within 60 days – creating an opportunity to expose information of poor quality, inspire media coverage, and influence public opinion, even where it is not possible to change agency action directly.

Moreover, in an indirect way, complaints under the Data Quality Act may have relevance to judicial review of agency actions. Under the Administrative Procedures Act, courts can strike down a policy as “arbitrary and capricious;” this was the basis of the recent district court decision reversing a number of HHS actions related to the vaccine schedule. One data point in a court’s consideration in an “arbitrary and capricious” analysis might be whether the agency has violated its own data quality policies or failed to respond reasonably to a complaint.

The second Trump Administration is excelling at providing material for complaints under the Data Quality Act. Multiple key decisions appear to be made based on questionable scientific data that was not vetted by career experts at the agencies, despite requirements for their engagement. Multiple statements by administration officials have lacked scientific support. And multiple reports appear to be written by people who just joined the administration, rather than following the orderly process of clearance by agency experts established under the law.

To date, most of the activity citing the Data Quality Act has come from the new administration itself. CDC cited the Data Quality Act as a justification for altering a website that previously had stated that vaccines do not cause autism on the grounds that “scientific studies have not ruled out the possibility that infant vaccines contribute to the development of autism.”

However, these website updates do not appear to have been implemented in a way consistent with the very law the administration is citing. In place of the required consultation with relevant agency experts, or peer review, the HHS Secretary said he “personally instructed” the site to be changed. The new site has come under heavy criticism from the scientific community, including the Autism Science Foundation and the leadership of the National Academies of Science, Engineering, and Medicine. But if there has been a complaint under the Data Quality Act, it has yet to be posted.

The new administration is also seeking to expand requirements under the law in ways that some experts believe are intended to complicate the process of federal regulation.

A law that began as an effort to fight federal regulation need not  be used primarily by those skeptical of mainstream science-based policy. Organizations that are now objecting to the scientific basis of HHS statements, reports, and actions should consider using the law as a tool for expressing their concerns.  One person did predict that the Data Quality Act would eventually come to be used by people across the policy and political spectrum. “I knew at some point in time, the [non-governmental organizations] were going to use it,” the law’s author Jim Tozzi said. “I kept on telling everyone, you just wait.”

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