ITSSD Programs - Theme #4 (2006-2013)
International Regulatory Transparency
Information Quality Act
"Providing an informed, reasoned and dispassionate
voice to the global public debate..."
Theme #4: Protection of the 'public interest' (constitutional protection of individuals' inherent right to 'due process of law') in an era of expanding international regulatory cooperation depends on the establishment, maintenance and oversight of mutually transparent risk-based best available science ("BAS") and economic cost-benefit-analysis-driven government regulatory and technical standards regimes that assure meaningful public participation and input. These regimes must provide public notice and comment mechanisms of sufficient duration prior to agency adoption of final rulemakings, and must offer adequate data/information quality review mechanisms to ensure the validity and reliability of agency and third-party-generated science & technical data/information prior to government dissemination and use of it as the bases for agency decision-making, including economically significant rulemakings and administrative enforcement actions.
The Information Quality Act (Data Quality Act), a procedural statute, was enacted by Congress on December 21, 2000 as an amendment (new Section 515, 44 U.S.C. 3516 note) to the Paperwork Reduction Act ("PRA") of 1980 (44 U.S.C. 3501-3520) which regulates government information collection and has been amended many times. The legislative history surrounding the Information Quality Act indicates the House Committee on Appropriations, which had inserted the Information Quality Act into the House Appropriations bill for 2001 (p. 362), was compelled to enact the IQA because of its ongoing lack of progress in securing cooperation from the Clinton Administration's Office of Management and Budget. For three years following Congress' 1995 enactment of PRA amendments (pp. 45, 81, 92), OMB had failed to issue rules with regard to data quality as the legislation had directed it to do. The 1995 PRA amendment had included statements of purpose directing federal agencies to ensure the quality and utility of information they disseminate to the public, and cited the need to improve the accountability of OMB and federal agencies for the "policies and guidelines" established under Act. Congress had mandated that the OMB Director promulgate "policies, principles, standards and guidelines" to apply to agency dissemination of information to the public. OMB had also ignored 1998 report language the House Appropriations Committee had included in a 1999 appropriations bill (pp. 49-50), which had urged OMB to fulfill its mandate by establishing "administrative mechanisms" by which affected persons could petition for correction of inaccurate agency information.
The House Committee Report accompanying the 2001 appropriations bill including the IQA explains on pp. 44-45 that Congress had required OMB "to develop [...] guidelines providing policy and procedural guidance to Federal agencies for ensuring and maximizing the quality, objectivity, utility and integrity of information disseminated by Federal agencies, and information by non-Federal entities with support from the Federal government, in fulfillment of the purposes and provisions of the Paperwork Reduction Act of 1995." (44 U.S.C. 3504(d)(1) and 3516; Section 515(a)). The IQA also required OMB to ensure that its guidelines require Federal agencies to establish administrative mechanisms allowing affected persons to seek and obtain correction of information maintained and disseminated by the agency that does not comply with the guidelines issued by OMB." (Section 515(b)(2)(A)).
The IQA is intended to ensure that influential scientific information agencies use as support for environment, health & safety regulations have been validated through use of the scientific method/process of investigation in conformance with federal law. Experts have referred to the development and application of scientific methods, tools, approaches and processes from various disciplines to reach law and policy decisions or outcomes as the evolving field of "regulatory science."
OMB's IQA-implementing Peer Review Bulletin was intended, in part, to create uniform high-level federal agency peer review institutional conflict-of-interest standards applicable to third-party-developed highly influential scientific assessments ("HISAs") federal agencies use and disseminate as support for major regulations, no matter whether agencies initially acquired the research and data ultimately incorporated in such HISAs by means of research & development procurement contracts or extramural grant awards and cooperative agreements.
Those opposed to the IQA, however, are concerned that its rigorous application would prevent the use of agency-disseminated third party scientific assessments (including risk assessments) as the basis for post-modern precautionary ex ante environmental, health & safety regulations or as support for expert testimony favoring post-hoc judicial relief in Daubert 'gatekeeper' science hearings. In other words, IQA opponents are generally precautionary principle proponents. Nevertheless, inasmuch as there are IQA proponents who find precautionary science anathema to rational regulation, some of whom are jurists, they have been inclined to view IQA-focused causes of action filed under the Administrative Procedure Act as analogous to private attorney general suits, and thus, closely scrutinize them on constitutional standing grounds.
Legal commentators (here) and (here) have referred to the Information Quality Act as a form of regulatory Daubert (Daubert v. Merrell Dow Pharmaceuticals, Inc.) insofar as it provides a mechanism to enable more rigorous, consistent review of agency science. To this end, OMB Guidelines implementing the IQA have been deemed consistent with the aims of regulatory Daubert, to increase the need for Daubert-type judicial review of agency science, and to assist Federal agencies in effectuating a separation between policy and science. Commentators have therefore argued that the courts have an important role to play in ensuring that federal agencies fully implement their IQA/OMB guideline obligations.
Full implementation by federal agencies of their IQA/OMB guideline obligations will likely increase agency accountability and transparency to the public and Congress, which will then be able to better oversee, agency science activities and processes "informed," "directed" and "controlled" by the executive offices of the White House (i.e., the Presidential Administration). Increased transparency, in turn, can help Congress to facilitate greater public involvement and participation in the rulemaking process, and perhaps, also help to encourage greater public confidence in government. In addition, full implementation by federal agencies of their IQA/OMB guideline obligations will reduce the risk of substantive bias and data manipulation/corruption.
The United States is unique among nations insofar as it has established model data/information quality standards which all Federal agencies must adopt and implement, consistent with their regulatory missions. In 2012, it was first reported that OMB's IQA-implementing data quality standards, along with the U.S. approach to risk analysis, economic cost-benefit analysis and regulatory impact analysis, were being discussed by the Transatlantic Economic Council and the U.S.-EU High Level Regulatory Cooperation Forum in connection with a desired Transatlantic Trade and Investment Partnership ("TTIP"). In February 2013, representatives from the Office of the United States Trade Representative and the European Commission had announced that formal TTIP trade negotiations had begun. As of July 18, 2014, six rounds of TTIP negotiations have been completed. However, these negotiations have been far from transparent. Although the EU has been somewhat forthcoming about its policy positions concerning "cross-cutting disciplines and institutional provisions" (i.e., "good regulatory practices"), the Obama Administration has not been transparent on these issues. As a result, the American public remains unaware of whether OMB's IQA standards ultimately will be upheld rather than moderated for the sake of achieving "international regulatory cooperation" - i.e., an avoidance of unnecessary divergences or differences in regulatory requirements and standards - in the name of securing a lesser political consensus-based "harmonised approach to data assessment (here"- p. 7), (here - p. 20), (here).
For this reason, it is imperative that Americans learn about the Information Quality Act and to insist that Congress and this administration ensure its full domestic and transatlantic implementation.
Relevant and Useful Information Quality Act (IQA) Resources are set forth below:
Treasury and General Appropriations Act for Fiscal Year 2001, Pub. L. No. 106-54, 114 Stat. 2763, 2763A-153-154, Sec. 515, codified at 44 U.S.C. Sec. 3516 note (here) & (here)
Office of Management and Budget, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by Federal Agencies ("OMB IQA Guidelines"), 67 FR 8452 (Feb. 22, 2002) (here)
Office of Management and Budget, Final Information Quality Bulletin for Peer Review ("OMB-PRB") (Dec. 16, 2004) (here)
United States Environmental Protection Agency, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by the Environmental Protection Agency ("EPA IQA Guidelines") (EPA/260R-02-008) (here)
- United States Environmental Protection Agency, Peer Review Handbook (EPA/100/B-06/002) (2006); (Modified Figs. 1 and 3); (2012); Addendum - Appearance of a Lack of Impartiality in External Peer Reviews (2009)
United States Environmental Protection Agency, Peer Review Policy; Peer Review Policy Memorandum (2006)
United States Environmental Protection Agency, EPA IQA Guidelines - Requests for Correction ("RFCs") and Requests for Reconsideration ("RFRs") Submitted to EPA (2002-2014)
Report 112-09, U.S. House of Representatives Committee on Science, Space and Technology, 112th Cong., 1st Sess., Hearing - Climate Change: Examining the Processes Used to Create Science and Policy (March 30, 2011)
Hearing, Energy and Environment Subcommittee of the U.S. House of Representatives Committee on Science, Space and Technology, Fostering Quality Science at EPA: Perspectives on Common Sense Reform (Nov. 30, 2011)