Ensuring the Quality of Data Disseminated by the Federal Government Workshop Report (2003) / Chapter Skim
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2. Overview of OMB Guidelines and Agency Concerns
2. Overview of OMB Guidelines and Agency Concerns
Pages 4-22
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John D Graham, administrator of the Office of Information and Regulatory Affairs at OMB, the office responsible for developing the government-wide Data Quality Guidelines.
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The guidelines subject government information to a higher standard than information generated by industry, academics, and public interest groups.
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Dr. Graham said that if an agency disseminates information in an official way, "then they do have a responsibility to assure that that information meets relevant quality standards in the agency guidelines and the OMB guidelines." Whether it was possible to obtain the original data would be decided in the same way as for information disseminated by an agency, noted Dr.
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Under the guidelines government information is "broadly defined" and under the statute "it is required to be of high quality." The OMB guidelines cover many types of information, said Professor Morrison, and all kinds of formats and media. The guidelines pay special attention to factual information, specifically "influential" scientific, financial, and statistical information.
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The OMB guidelines take special note of the Internet, which both "enables agencies to communicate information quickly and easily to a wide audience" and also "increases the potential harm that can result from the dissemination of information that does not meet basic information quality guidelines." Many uses of information are not considered dissemination if they are intended for a limited audience or a specific setting. Professor Morrison suggested the following examples of information use that are not acts of dissemination: a response to a FOIA request; a response to a letter; and information provided during adjudication.
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What Is the Complaint Mechanism? Professor Morrison noted that while under the Administrative Procedures Act, the public has the right to complain about the quality of agency data, the OMB guidelines strengthens that right by requiring that the agencies respond to the complaint.
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Professor Morrison noted that while the information may have influence, "I do not believe that the statute puts the burden on the agency to worry about what somebody else may do with the information." DETERMINING THE THRESHOLD-INFLUENTIAL SCIENTIFIC, STATISTICAL, AND FINANCIAL INFORMATION Richard Merrill, Professor of Law at the University of Virginia, moderated a panel discussion on agency approaches to determining influential information. The panel comprised Nancy Kirkendall, Energy Information Administration of DOE; Steven Galson, FDA; and Fred Siskand, DOL.
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Some examples of DOL influential information include the Consumer Price Index, Producer Price Index, and other national economic indicators. He said that DOL was still working on its definition of influential.
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The OMB guidelines suggests that to be objective, information should be produced by methods that are "transparent" and should be reproducible by others. The goal of transparency for data and methods, according to the guidelines, is "to facilitate the reproducibility of such information." The guidelines add, "Where appropriate, data should have full, accurate, transparent documentation, and error sources affecting data quality should be identified and disclosed to users."
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experiment and it may not be feasible to replicate, for example, the radiation exposures studied after the Chernobyl accident." Thus the guidelines urge agencies to consider "which categories of original and supporting data should be subject to the reproducibility standard and which should not," and that they should make this determination with the help of "relevant scientific and technical communities." The second category is analytic data. OMB states that "reproducibility is a practical standard to apply to most types of analytic results." The guidelines add: "With respect to analytic results, 'capable of being substantially reproduced' means that independent analysis of the original or supporting data using identical methods would generate similar analytic results, subject to an acceptable degree of imprecision or error." The primary benefit, according to the guidelines, would be to allow the public to "assess how much an agency's analytic result hinges on the specific analytic choices made by the agency." The OMB guidelines also acknowledge that the "objectivity standard does not override other compelling interests such as privacy, trade secrets, intellectual property, and other confidentiality protections."
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Taylor, Resources for the Future, moderated a panel discussion regarding agency approaches to achieving objectivity. He opened the session by noting the "irony" of a law (the Data Quality Act)
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It is a very slight modification of the way we have always done business." Dr. Kevin Teichman of the Environmental Protection Agency said that the criteria for defining transparency are found in EPA's risk characterization handbook, which requires description of the approach one is using, the assumptions made, models used, where data gaps exist, where one extrapolated from the data, what the uncertainties are, where one is using data or relying on defaults, and where one is making scientific conclusions as opposed to policy decisions.
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He said he was curious to see whether the agency would move "peer review outside the scientific community and into the operating context where the FAA operates, how successful we will be in creating entities to do peer reviews." Earlier in the workshop, Dr. Steven Galson said that the FDA strives for a high degree of transparency in the high volume of health-related information it disseminates publicly, including risk notices, rule-making documents, product approvals, guidance and regulatory assistance, and reports.
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Dr. Teichman of the EPA responded that "we would certainly hope that all of the data the agency would use would follow the best possible practices, good laboratory practices and others that would comply with the OMB data quality guidelines." Dr.
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Dr. William Perry agreed with the 1983 Academies report that risk analysis should include hazard identification, dose-response assessment, exposure assessment and risk characterization.
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Dr. Galson added, "Although we analyze the economic costs of these regulations and consider alternatives, most of our regulations simply don't lend themselves to the type of quantitative risk assessments that are contemplated by the Safe Drinking Water Act principles." In addition, many FDA actions are based on research and supporting data generated in biotech or drug companies.
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The guidelines recognize that most agencies already have mechanisms to respond to complaints, but they now require agencies to respond directly to complainants and to itemize their complaint history for OMB at the end of each year. They also require each agency to add an appeals process for the benefit of complainants, with "appropriate time limits in which to resolve such requests for reconsideration." A panel discussion, moderated by Frederick R
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He said that "the statute talks about a review mechanism looking at agency compliance with the OMB guidelines not actually whether the information itself is correct or incorrect, but whether the agencies complied with a process for developing that information." Mr. Cohen noted that there is some confusion over legal standing, with some suggesting that affected and standing are equivalent.
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" Ms. Elaine Stanley of the Environmental Protection Agency discussed the agency's web-based integrated error correction system that the agency was considering using as part of the data quality correction process.
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