The Data Quality Act: Toward Greater Accountability in Regulation

It is safe to say that, when the Data Quality Act ("DQA") was signed into law by President Clinton in December 2000, it drew very little attention in either the public or private sector. Yet it has already begun to enhance dramatically the ability of regulated entities to participate meaningfully in administrative rulemaking. Only rarely does a piece of legislation with such potentially far-reaching implications slip by so unnoticed. We believe the DQA may become an important new tool for regulated entities to use to ensure that only "good science" is employed in the formulation of complex federal rules.

The DQA was inconspicuously enacted as part of the FY 2001 Consolidated Appropriations Act. It amends the Paperwork Reduction Act ("PRA") and directs the Office of Management and Budget ("OMB") to develop government-wide standards which "provide policy and procedural guidance to Federal agencies for ensuring and maximizing the quality, objectivity, utility, and integrity of information (including statistical information) disseminated by Federal agencies." The goal is to ensure that information used and disseminated by federal agencies is of consistently high quality. The DQA was not intended to imply that all government information was lacking in quality. There was sufficient awareness, however, that the statistical, scientific, and other types of information which frequently provide the basis for important administrative decisionmaking may not always be of a quality to justify new administrative burdens on the regulated community.

The Statute's Requirements Are Simple

The thrust of the DQA is to direct OMB, through government-wide guidelines, to require that each federal agency, in turn, issue its own data quality guidelines ensuring and maximizing the quality, objectivity, utility, and integrity of the agency's information. If this were all the Act said, it would have little impact, for the response of a number of agencies has been that they already disseminate high-quality information. But the DQA provides more. It gives the public the ability to force a prompt examination of whether the agency has, indeed, adhered to high data quality standards in specific situations. Under the Act, OMB must require each federal agency to establish administrative mechanisms that allow affected persons "to seek and obtain correction of information maintained and disseminated by the agency that does not comply with [its] guidelines." Thus, the public can challenge the validity, reliability, and soundness of the information and data used by the agency to advance particular initiatives. The Act promotes transparency and public accountability. Finally, federal agencies are required to report periodically on the number and nature of complaints received by the agency regarding the accuracy of its information and how such complaints were handled by the agency.

Where did this sweeping enactment originate? It seems to have been a logical outgrowth of the information age, a response to our ever-increasing recourse to the Internet. It was reported, after the fact, that the DQA was the brainchild of certain corporate interests who sought a mechanism for controlling indiscriminate dumps of corporate data into federal Internet sites. Indeed, its congressional sponsor, Representative Jo Ann Emerson (R-MO), explained that her goal was to ensure that information on federal agency websites was accurate, objective, and useful. Some also noted that the effort may have had its origins in the frustrations experienced by industry opponents to EPA's 1997 revisions to the ozone and particulate matter clean air standards when those interests were denied access to certain raw medical data on which the standards were based. Whatever its source, the DQA will undoubtedly change the way federal regulators and the regulated community conduct their business.

The OMB Guidelines

True to its charge, OMB issued its guidelines in final form on February 22, 2002. The guidelines are sensitive to the variety of circumstances in which they will apply and to the need for a "common-sense and workable" approach that fits a particular agency's existing information resources management and administrative practices. At the same time, "the essence of the guidelines [must] apply." The agency must set "performance goals" by which others, including the public and OMB, can measure improvements in information quality. Agencies must "make their methods transparent by providing documentation, ensure quality by reviewing the underlying methods used in developing the data and consulting (as appropriate) with experts and users, and keep users informed about corrections and revisions."

"Quality" Defined

OMB defines the term "quality" as encompassing "utility," "objectivity," and "integrity." "Utility" refers to the usefulness of the information to its intended users, including the public. The agency needs to consider the uses of the information, not only from the agency's own perspective, but also from the perspective of the public. "Objectivity" focuses on whether the information is being presented in an accurate, clear, complete, and unbiased manner and whether it is presented in the proper context. Also, as a matter of substance, the information must be accurate, reliable, and unbiased. The agency needs to identify the sources of its information (consistent with confidentiality protections) and, "in a scientific, financial, or statistical context, [it needs to identify] the supporting data and models, so that the public can assess for itself whether there may be some reason to question the objectivity of the sources." "Integrity" refers to security - "the protection of information from unauthorized access or revision to ensure that the information is not compromised through corruption or falsification."

The "Dissemination" of "Information"

Under OMB's definition, "information" means any communication or representation of knowledge such as facts or data, in any medium for form, including textual, numerical, graphic, cartographic, narrative, or audiovisual. It does not include opinions, "where the agency's presentation makes it clear that what is being offered is someone's opinion rather than fact or the agency's views." "Dissemination" means "agency initiated or sponsored distribution of information to the public," such as a risk assessment prepared by the agency to inform its formulation of possible regulatory or other action, or where the agency requests a third party to conduct research and then directs the person to disseminate the results or has authority to review and approve third-party information prior to release. There are limited exceptions. For example, "dissemination" does not include "distribution limited to correspondence with individuals, . . . press releases, archival records, public filings, subpoenas, or adjudicative processes."

Subsets of Information to Which Even Higher Standards Apply

Under the regulations, there are certain types of information are subject to higher standards - "influential" information, and assessments of health, safety, and environmental risks.

"Influential" Information. Stricter standards apply if the information is considered "influential." Each agency is authorized to define "influential" in ways that are appropriate for the nature and multiplicity of issues it addresses. However, "influential" scientific, financial, or statistical information means that "the agency can reasonably determine that dissemination of the information will have or does have a clear and substantial impact on important public policies or important private sector decisions." An agency that is responsible for disseminating "influential scientific, financial, or statistical information" shall provide in its guidelines for "a high degree of transparency about the data and methods to facilitate the reproducibility of such information by qualified third parties."

"Reproducibility" means that the data is "capable of being substantially reproduced," subject to an acceptable degree of imprecision. The purpose of the "capable of being substantially reproduced" standard is not to require that the agency actually reproduce analytical results prior to dissemination, but to encourage a commitment to such transparency about data and methods that an independent reanalysis could be undertaken by a member of the general public. In situations in which trade secrets, privacy, or confidentiality compete with the right of public access to data and methods, the agency will be expected to "apply especially rigorous robustness checks to analytical results and document what checks were undertaken."

Assessments of Health, Safety, and Environmental Risks. The DQA requires agencies that perform analyses of risks to human health, safety and the environment to employ, in the scientific context, the basic standard of quality for the use of science in agency decisionmaking that Congress adopted in the 1996 amendments to the Safe Drinking Water Act ("SDWA"). Under the SDWA standard, to the degree that an agency action is based on science, the agency must use the best available, peer-reviewed science and data collected by acceptable methods or best-available methods. It must ensure that the presentation of risk information is comprehensive, informative, and understandable, that it clearly specifies each population at risk, together with the realistically expected risk or central estimate of risk (not just the worst case) for specific populations. The agency must specify each significant uncertainty identified in the assessment process and the studies that may assist in resolving the uncertainties, and it must identify known studies that either support or fail to support the estimate of risk and the method by which those studies were reconciled.

The "Correction" Process

As noted above, the DQA requires agencies to provide administrative mechanisms that allow affected persons to seek and obtain timely correction of information that does not comply with agency guidelines. The goal is to provide broad public access to a structured complaint process. Agencies must specify appropriate time periods within which they will decide whether and how to correct the information. Rapid turnaround is the goal. If the person seeking correction does not agree with the agency's decision, that person may file for reconsideration within the agency. The agency must provide an objective administrative appeals process which ensures that the office which originally disseminates the information does not have responsibility for both the initial response and the resolution of the disagreement. Though some would strongly disagree, "OMB does not envision administrative mechanisms that would burden agencies with frivolous claims." The goal is clearly to enhance agency decisionmaking and the responsiveness of the traditional notice and comment rulemaking process where there is a likelihood that delay in the review of foundational information could result in actual harm.

The federal agencies were required to issue their own guidelines by October 1, 2002 ensuring the "quality, objectivity, utility, and integrity" of the information they disseminate. Links to final agency guidelines are provided at the OMB website, (

The correction mechanisms provided in individual agency guidelines have rather quickly become the basis for some targeted challenges. For example, using Environmental Protection Agency ("EPA") guidance that was made available on October 15, 2002, the Center for Regulatory Effectiveness ("CRE") filed a petition in November 2002 on behalf of the Kansas Corn Growers Association and the Triazine Network challenging "EPA disseminations of information relating to the purported endocrine effects of the herbicide atrazine" on grounds that there are no validated test methods for assessing such effects. Similarly, a producer of barium chemicals petitioned EPA in October 2002 for correction of the reference dose for chronic oral exposure to barium and compounds which is reflected in EPA's Integrated Risk Information System on grounds that it is neither objective nor reproducible. EPA has used the reference dose to set a stringent hazardous waste standard which the company alleges has harmed its business. CRE has also used the DQA to challenge the National Highway Transportation Safety Administration's proposed collection and reporting of information on potential vehicle defects. Environmental and other activist groups have expressed some concern over the ability industry now has to demand correction of health and safety-related information.

Final Agency Actions?

One burning question yet to be conclusively resolved is whether agency DQA decisions will be reviewable in court as final agency actions. The likelihood is that they will be. Neither OMB nor the individual federal agencies have the option of declining to write guidelines, nor is any agency free to disregard its own guidelines once issued. The Act was clearly intended to impose binding government-wide requirements that can have a direct and significant impact on affected persons and companies. When a petition for correction is denied, then reconsidered and denied again (when administrative remedies have been exhausted) - perhaps even before then, depending on whether the agency action is final under Darby v. Cisneros - the presumption will likely be in favor of judicial review. It can be expected that this question will soon be presented to the courts for determination.

In any event, business interests now have a new tool for self-defense and a new opportunity to protect against irresponsible over-regulation and ill-conceived regulatory constraints. The DQA is a welcome addition to the regulatory landscape. It may have been a sleeper when enacted, but the DQA is poised to make a major wake-up call to the federal bureaucracy.

Crowell & Moring LLP is an international law firm with more than 500 lawyers representing clients in litigation and arbitration, regulatory, and transactional matters. The firm is internationally recognized for its representation of Fortune 500 companies in high-stakes litigation, as well as its ongoing commitment to pro bono service and diversity. The firm has offices in Washington, DC, New York, Los Angeles, San Francisco, Orange County, London, and Brussels.

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