SM: CRE Regulatory Action of the Week
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
Mr. Donald R. Arbuckle
Larry Fine, M.D., Dr.P.H.
Mr. James Seligman
Dear Mr. Arbuckle, Dr. Fine, and Mr. Seligman:
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 (www.cdc.gov/niosh, 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:
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:
"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:
(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:
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":
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 recommendations for resolving the HID 10 data quality controversy
CRE recommendations for development of the enhanced data quality rules
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.
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 (www.thecre.com), was a proposal by the Office of Federal Housing Enterprise Oversight (OFHEO) to develop and issue information relating to risks to the nations housing financing sector.
3. The full text of the OMB letter can be found on the CRE website (www.thecre.com) 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.