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Reg WeekSM: CRE Regulatory Action of the Week

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CRE Uses NIOSH Hazard ID on Biosolids as Case Example of Issues That Should Be Addressed in New OMB and Agency Data Quality Rules, as Well as Under Existing OMB Guidance

In July, NIOSH issued a Hazard alert (HID 10) concerning bacteria detected at a biosolids land application facility, and potential gastrointestinal sickness that might be associated with the presence of pathogens. NIOSH also recommended measures to mitigate the potential exposures. Controversy ensued concerning whether there was a sound basis for the alert and its recommendations, and the controversy has not yet been resolved. CRE has written to OMB and NIOSH, including its Chief Information Officer, to point out (a) the types of issues raised by the controversy that should be addressed in the data quality rules which OMB and agencies are now required to issue; and (b) existing OMB guidance on data quality which should be utilized in the interim to resolve this and similar data quality controversies.

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         March 9, 2001

    Mr. Donald R. Arbuckle
    Deputy Administrator
    Office of Information and Regulatory Affairs
    Office of Management and Budget
    Eisenhower Exec. Offc. Bldg., Rm. 10201
    17th St. and Pennsylvania Ave., NW
    Washington, DC 20503

    Larry Fine, M.D., Dr.P.H.
    Acting Director, NIOSH
    Centers for Disease Control
    Hubert H. Humphrey Bldg, Rm. 715H
    200 Independence Ave., SW
    Washington, DC 20201

    Mr. James Seligman
    Chief Information Officer
    Centers for Disease Control
    1600 Clifton Rd.
    Bldg. 16, Rm. 5109
    MS D15
    Atlanta, GA 30333

    Dear Mr. Arbuckle, Dr. Fine, and Mr. Seligman:

         In October, new legislation directed OMB and all Federal agencies to move ahead with development and promulgation of new guidance/rules on data quality, as previously required by the Paperwork Reduction Act of 1995, but now within specific timeframes. The OMB rules are due out by September 30 of this year, and the agency-specific rules within a year after the OMB rules. We are writing to recommend that you consider, utilize, and take action to resolve, a specific case example that illustrates a number of broad issues that should be addressed in those new rules, and which also illustrates the need for interim application and implementation of current OMB guidance on data quality. That case example is NIOSH Hazard ID number 10 ("HID 10") concerning worker exposure to biosolids during and after field application.

    NIOSH HID 10 as a case example

         On July 28, 2000, NIOSH issued HID 10, which described alleged potential pathogenic risks to workers handling or inhaling Class B biosolids used as fertilizer, and recommending actions to mitigate such risks. The HID was immediately posted on the NIOSH website (, under "Publications"1), along with a press release.

         The release of HID 10 provides a good example of the practical potential for regulation by information.2 The HID was quickly picked up by the national media, was noted by interest groups and state and local government officials, and has resulted in pressure for bans on the land application of Class B biosolids, although such impacts were not intended by NIOSH and are contrary to EPA determinations that use of biosolids does not imperil the public when properly managed.

         Shortly prior to the release of HID 10, the Association of Metropolitan Sewerage Agencies ("AMSA") learned of NIOSH's intent to issue the HID, and wrote to the Director to object to issuance of the HID without NIOSH having sought prior consultation with interested parties outside the government and with EPA, particularly in view of the potential for such a publication to alarm the public and undermine a national performance goal of increased biosolids reuse.

         Subsequent to the release of the HID, AMSA, the Water Environment Federation ("WEF"), and members of the National Biosolids Partnership corresponded and met with NIOSH officials and scientists to express their concerns and seek a resolution. It is our understanding that the most recent letter was sent to NIOSH in early October 2000, and that NIOSH has not responded and that there has been no resolution of the issues raised.

    Data quality issues illustrated by the NIOSH example

         In generic terms, the data quality issues raised to NIOSH have included the following:

    • failure to seek prior consultation with parties having special expertise or likely to be impacted

    • controversy concerning the adequacy of the scientific basis for determining that there was a need to address a significant safety hazard, and possible conflicts with available scientific data

    • controversy concerning the scientific basis for some of the management recommendations

    • overlap and apparent conflict with research and conclusions by another agency (EPA)

    • ambiguities in the management recommendations that appeared likely to confuse the public

    • failure to consider the serious unintended impacts that could result from issuance of the HID and to take measures to prevent or mitigate such impacts

    Current OMB guidance on data quality applicable to the NIOSH case example

         Another matter, which we believe we need to call to your attention is the applicability of current OMB guidance concerning data quality in the interim while the enhanced data quality guidance required by the new legislation is being developed.

         The original Congressional directives concerning data quality policy and issuance of data quality rules were contained in the Paperwork Reduction Act of 1995 ("PRA"); the recently-enacted provisions in the appropriations legislation supplement those PRA provisions. OMB has issued (and recently revised) guidance for complying with the PRA, as well as for other information systems and collection authorities, in OMB Circular A-130. There are provisions in that Circular that currently address data quality issues under the information dissemination provisions of the PRA, and that must be applied to the NIOSH HID 10 situation.

         When the FY2001 appropriations bill provisions were under consideration by Congress, the Administrator of OMB's Office of Information and Regulatory Affairs, Mr. John Spotila, wrote to Representative Jo Ann Emerson on April 18, 2000, in response to her inquiry as to what OMB had done to respond to Congressional report language for the FY 1999 appropriations bill urging OMB to proceed expeditiously with issuance of the data quality guidance required by the PRA.3 Mr. Spotila pointed out that OMB Circular A-130 already addressed data quality, while conceding that it might not be sufficient. He wrote:

      We appreciate the need for ensuring such quality [of federally-disseminated information] and are sensitive to the possibility that OMB Circular A-130 might need to be updated or supplemented to deal with concerns in this area. OMB circular A-130 already establishes complaint resolution procedures for perceived violations of data quality and other requirements in the Circular. Section 9(a)10 of the Circular contains a requirement that each agency CIO must:

        "Monitor agency compliance with the policies procedures, and guidance in this Circular. Acting as an ombudsman, the [CIO] shall consider alleged instances of agency failure to comply with this Circular and recommend or take corrective action as appropriate."

      The Circular also contains a specific requirement for agencies to report to OMB any alleged violations and their resolution:

        "The [CIO] shall report annually, not later than February 1st of each year, to the Director those instances of alleged failure to comply with this Circular and their resolution."4

    (Emphasis added.) While the Spotila letter does not contain citations to the specific existing data quality requirements of Circular A-130 which are referred to, a review of the Circular reveals the following relevant provisions:

    • Under "Basic Considerations and Assumptions" the Circular states that "[i]t is . . .essential that the government . . . maximize the usefulness of government information." Sec. 7, c.5

    • Under "Policy", the Circular states:

      — Agencies are to "[c]onsider the effects of their actions on members of the public and ensure consultation with the public as appropriate. . . ." Sec. 8,a,1, (b).

      — "In determining whether and how to disseminate information to the public, agencies will [disseminate information with the goal of] maximizing the usefulness of the information . . ." Sec. 8, a, 5, (d).

      — Agencies must "[e]stablish and maintain communications with members of the public and with State and local governments so that the agency creates information dissemination products that meet their respective needs . . ." Sec. 8, a, 6, (i)

      — Agencies must "Provide adequate notice when initiating, substantially, modifying, or terminating significant information dissemination products. . ." Sec. 8,a,6, (j).

         A key substantive term in the above mandatory policy directives is "usefulness" B in disseminating information to the public all agencies must attempt to maximize the "usefulness" of the information. While the Circular does not itself define the term "usefulness", the OMB regulations implementing the information collection portions of the PRA incorporate this term and clarify its meaning through the definition of "practical utility":

      Practical Utility means the actual, not merely the theoretical or potential usefulness of information . . . , taking into account its accuracy, validity, adequacy, and reliability. . . .

    5 CFR § 1320.03(l) (underlining added).

         OMB has made it clear that Circular A-130 in its current form contains enforceable "data quality requirements". The requirement for "usefulness" derives substance from the meaning given that term through OMB's definition of "practical utility": That is, to be "useful", information disseminated to the public must be evaluated for its "accuracy, validity, adequacy, and reliability." That definition should therefore guide agency CIOs in carrying out their data quality responsibilities until new and enhanced guidance is promulgated.

    CRE observations

    • Because the existing OMB requirements concerning data quality lack sufficient visibility, parties impacted by such products are unlikely to be aware of the "ombudsman" duties of agency Chief Information Officers. In the NIOSH case example noted above, the parties did not correspond or meet with the CIO; however, it is the responsibility of the agency to communicate with its CIO, and it appears that other agency officials have not taken the initiative to inform and include the CIO. Under such circumstances, the CIO is not in a position to "take action" to resolve the issues, as required by the OMB guidance.6

    • The new OMB and agency rules should contain a very clearly defined and simple process for seeking correction or improvement of agency information dissemination products that provides for a clear resolution or answer within a specific timeframe.

    • Affected parties are also unlikely to be aware of the connection between the requirement in the OMB information dissemination guidance to maximize the "usefulness" of information products and the definition of "practical utility" in the OMB information collection regulations.

    • Although sparse, the data quality provisions in the current OMB Circular contain some core concepts that should be maintained, such as prior consultation with parties likely to be affected by new or modified information products, and designation of a single senior official responsible for implementing OMB and agency data quality guidance.

    • Case examples such as the NIOSH HID 10 situation should prove very useful to OMB and the agencies in developing the new data quality rules and guidance required by the PRA and the FY2001 Consolidated Appropriations Act. Concerned parties in all sectors of the business and public interest communities should participate in providing such input to OMB and the agencies.

    • Agency-specific data quality rules may not be promulgated until late 2002 or later. Meanwhile, there is clear, albeit general, Congressional and OMB policy for maximizing the quality of government information dissemination products which should be followed. Portions of the policies and directives, such as prior consultation, the requirement for a mechanism for correction of information, and the terms "usefulness" and "objective", have clear meanings even in the absence of more precise guidance, and compliance is required by the current OMB guidance.

    CRE recommendations for resolving the HID 10 data quality controversy

    1. NIOSH officials should forward all documentation concerning the controversy to their responsible CIO.

    2. The CIO should have the HID withdrawn pending compliance with the OMB Circular provisions.

    3. The CIO should assume responsibility for ensuring that the controversy is resolved consistent with OMB guidance.

    4. The agency should review its pertinent delegations to ensure that its CIO has been vested with the appropriate degree of authority and responsibility required by the data quality provisions of Circular A-130.

    5. The CIO should report to OMB on how the controversy was resolved.

    CRE recommendations for development of the enhanced data quality rules

    1. OMB should convene and announce as soon as possible an inter-agency task force to provide assistance in the development of the OMB data quality rules, as required by the legislation.

    2. Each agency should designate a data quality team to assist in providing input for development of the OMB rules and to begin consideration of the rules that will be needed for their own agency so that they can make recommendations to OMB that will be consistent with their own agency's needs.

    3. Agency data quality teams should actively seek out and solicit examples of data quality issues raised by information products disseminated by their agency to use as case examples in providing input for development of the OMB rules and their own rules.

    4. OMB, together with the individual agencies, should publicize their plans for working together on development of the OMB rules.

    5. OMB and the individual agencies should issue Federal Register notices announcing their plans for seeking public involvement in development of the OMB and agency rules and for seeking case examples and identifying issues.

    6. In the interim, while the new OMB rules are being developed, OMB should notify all agencies that they must follow the existing OMB requirements pertaining to data quality contained in Circular A-130, and reasonably ascertainable from the Congressional policy and directives in the 1995 and 2000 legislation.

         Since it appears that the current OMB guidance and legislative directives have not been followed in the NIOSH HID 10 situation, we request that OMB and NIOSH inform us of how they intend to ensure that the guidance is applied to this situation and others until the new rules are developed, and how the situation is ultimately resolved. We would also appreciate receiving your reactions to the above recommendations concerning development of the new data quality rules, and we would particularly like to be informed of OMB and agency plans to take specific actions in furtherance of developing those rules.


    Jim J. Tozzi
    Member, CRE Advisory Board


    1. The "Publications" section of the NIOSH website illustrates the great variety of information products disseminated by the agency without a formal regulatory process.

    2. The Center for Regulatory Effectiveness (CRE) has been in the forefront of efforts to achieve appropriate implementation of the 1995 and 2000 Acts. One important component of those efforts is the identification of actual case examples and the issues they raise in order to inform that process. The first such case example which we have explored, discussed on the CRE website (, was a proposal by the Office of Federal Housing Enterprise Oversight (OFHEO) to develop and issue information relating to risks to the nations housing financing sector.

    3. The full text of the OMB letter can be found on the CRE website ( in the "data quality" section.

    4. After this letter, the Circular was revised on Nov. 30, 2000; however, the quoted provisions remain, with very minor (non-substantive) editing, and are now in subsection 9, a, 4.

    5. All references are to the Nov. 30, 2000 revisions of the Circular.

    6. A copy of the original AMSA letter was designated for OMB, but there was no copy designated for the CDC CIO. Subsequent correspondence did not designate a copy for either OMB or the CDC CIO.

    In the April 18, 2000 letter to Representative Emerson, OMB's Mr. Spotila stated that OMB had canvassed agency CIOs about data quality, and they indicated that they had not been hearing complaints about the quality of federally-disseminated information. The NIOSH HID 10 situation suggests that it is likely that agency CIOs never even hear about such complaints because affected parties are not aware that such complaints should be sent to the CIO, and because other agency officials do not seek CIO involvement. In the NIOSH case example, it is noteworthy that the CDC CIO is located in Atlanta, while meetings with the concerned parties apparently were held in the offices of NIOSH officials in Washington, DC. This suggests that CIOs should be located in headquarters when possible.