NEW DATA QUALITY GUIDELINES FINALIZED BY OFFICE OF MANAGEMENT AND BUDGET - On 27 September 2001, the Office of Management and Budget published the final data quality guidelines, which are intended improve the quality of information that federal agencies use and disseminate to the public. These guidelines, issued by OMB's Office of Information and Regulatory Affairs, apply to facts, statistics, and technical information used by government officials and the public. OMB's action implemented a Congressional directive in the FY 2001 Treasury-Postal appropriations bill. The guidelines, originally proposed by Representative Jo Ann Emerson, R, MO, will take effect on October 1, 2002 but agencies will have one year to develop conforming guidelines and implementing mechanisms. Agency guidelines will also be published for comment.

It appears that OMB gave serious consideration to the concerns raised by the nearly 50 scientific organizations and academic institutions that submitted comments on the proposed guidelines. Most significantly, it appears that the guidelines would not ordinarily apply to grantees. The guidelines apply only to information that is disseminated on behalf of an agency if the dissemination is done at the agency's specific request or with the agency's specific approval.

OMB explicitly acknowledged the value of the peer review process: the guidelines provide if the [research] results have been subject to formal, independent, external peer review, the information can generally be considered of acceptable objectivity. Further, the definition of integrity was limited to the security of information - "protection of the information from unauthorized access or revision, to ensure that the information is not compromised through corruption or falsification." Scientific organizations and institutions were greatly concerned about the proposed requirement of "reproducibility" as an element of the required level of data quality. OMB addressed this concern by making it clear that the requirement of "substantial reproducibility" was limited to study results. The final guidelines reads, "the results must be capable of being substantially reproduced, if the original or supporting data are independently analyzed using the same models. Reproducibility does not mean that the original or supporting data have to be capable of being replicated through new experiments, samples or tests." However, OMB has also re-opened the comment period for this particular issue, saying that, "While, in deference to the statutory deadline, OMB is issuing the "capable of being substantially reproduced" standard (paragraphs V.3.B, V.9, and V.10), OMB is doing so on an interim final basis. We specifically request public comments on this standard by October 28, 2001."

However, OMB rejected suggestions for preventing frivolous or non-meritorious challenges to agency data, saying that "OMB does not envision administrative mechanisms that would burden agencies with frivolous claims. Instead, the correction process should serve to address the genuine and valid needs of the agency and its constituents without disrupting agency processes. Agencies, in making their determination of whether or not to correct information, may reject claims made in bad faith or without justification, and are required to undertake only the degree of correction that they conclude is appropriate for the nature and timeliness of the information involved, and explain such practices in their annual fiscal year reports to OMB." But because the legislation upon which the guidelines are based does not bar administrative or judicial review of agency action, OMB's response does nothing to protect agencies from the potential abuse of the challenge mechanism. AIBS and other scientific organizations had suggested a number of common-sense devices that we hope the agencies, in developing their conforming procedures, will implement. These included a requirement that challengers have the burden of proof to show a lack of "quality" as defined in the guidelines and that challengers be required to show that an equally qualified scientist (s), i.e., a peer, has found fault with the integrity.

OFFICE OF MANAGEMENT AND BUDGET STEPS UP OVERSIGHT ROLE - The White House Office of Management and Budget has announced that it will review all "significant" regulations for strict compliance with a host of requirements and guidelines, including risk assessments, peer review and analyses of the rules' impact on state, local and Indian governments, on energy supplies and on small businesses. OMB's Office of Information and Regulatory Affairs advised federal agencies that it will emphasize "science-based" procedures -- including cost-benefit analyses -- in evaluating proposed regulations. John D. Graham, OIRA administrator, said in a news release, "Our goal is to improve the regulatory process, adopting cost-effective rules when they are needed, modify existing rules to make them more effective and/or less costly, and rescind outmoded rules." Graham said he would send back those rules that lack an adequate cost-benefit analysis and reasonable alternatives. A wide range of environmental groups, some unions, and the government watchdog groups Public Citizen and OMB Watch opposed Graham's appointment to OMB, saying that Graham is an ally of business whose cost-benefit analyses overstate the costs and underestimate the health and environmental benefits. This new activism on the part of OMB has raised concerns the agency, under Graham's influence, will impede the development of health, safety, and environment regulations. Prior to his appointment to OIRA, Graham, whose academic training is in economics and public policy, founded and led Harvard's Center for Risk Analysis (HCRA). Opponents of Graham's nomination documented that the HCRA was supported, in large part, by donations from dozens of corporations, many of them subject to myriad federal regulations. Most HCRA executive council members have substantial ties to these industries. Numerous federal agencies, including the NSF, EPA, NOAA, and the USDA have provided funding to the HCRA.

OMB TAKES UNUSUAL MEASURE IN URGING NEW REGULATION - The Washington Post reported September 21 that the Office of Management and Budget urged two federal agencies to adopt new regulations. OMB's two "prompt letters" - one to the Department of Health and Human Services urging the labeling of trans-fatty acid content in foods and the other to the Occupational Safety and Health Administration, urging the approval of automated external defibrillators - were apparently unprecedented. The OMB said this is the first time the agency "has publicly used its analytic resources to encourage new regulatory actions as opposed to reviewing decisions initiated by agencies." The letters do not carry legal weight but are meant to draw "agency and public attention to important issues that warrant consideration and action," said OMB Office of Information and Regulatory Affairs head John Graham. The move surprised many who view OMB's new head of the Office of Information and Regulatory Affairs, John Graham as a foe of health and environmental regulation. Science and environmental watchdog groups gave mixed reactions to the move. Although OMB's actions signal that Graham is not inalterably opposed to health and environmental regulations, some wonder if OMB is going to substitute its judgment for that of agency expertise.

PRESIDENT'S COUNCIL OF ADVISORS ON SCIENCE AND TECHNOLOGY CONTINUED BY BUSH ADMINISTRATION - By Executive Order 13226, dated 30 September 2001, President George W. Bush continued the President's Council of Advisors on Science and Technology (PCAST) for another two years. PCAST was originally established by President George H.W.Bush in 1990 to enable the President to receive advice from the private sector and academic community on technology, scientific research priorities, and math and science education. The Executive Order provides that PCAST shall be composed of not more than 25 members, one of whom shall be a federal government official designated by the President and 24 of whom shall be nonfederal members appointed by the President and have diverse perspectives and expertise in science, technology, and the impact of science and technology on the Nation. The designated federal official shall co-chair PCAST with a nonfederal member designated by the President. The PCAST shall advise the President, through the Official, on matters involving science and technology policy. In addition, the PCAST shall assist the National Science and Technology Council (NSTC) in securing private sector involvement in its activities. The Executive Order also permits PCAST to convene ad hoc working groups to provide preliminary, nonbonding information and advice directly to the PCAST.

ADMINISTRATION SUBMITS FORMAL NOMINATION OF MARBURGER TO HEAD OFFICE OF SCIENCE AND TECHNOLOGY POLICY - On September 21, the White House formally nominated John Marburger III as Assistant to the President for Science and Technology Policy. The nomination was originally announced on June 25. The Senate Committee on Commerce, Science, and Transportation has scheduled a hearing on the nomination for early October.

BUSH TO NOMINATE LAUTENBACHER TO HEAD NOAA - On September 19th, President Bush announced his intent to nominate Vice Admiral Conrad C. Lautenbacher, Jr. (ret.) to be the new Administrator for the National Oceanographic and Atmospheric Administration (NOAA). Lautenbacher is currently the President of the Consortium for Oceanographic Research and Education (CORE). A former Deputy Chief of Naval Operations who has also served as staff director for the Chairman of the Joint Chiefs of Staff, Lautenbacher holds a Ph.D. from Harvard University in applied mathematics. Once the nomination is formally submitted, Senate approval is required.


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