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Reg WeekSM: CRE Regulatory Action of the Week

CRE Petitions CIO on NIOSH Biosolids Hazard ID Document
After receiving an unsatisfactory response to an earlier CRE letter raising data quality issues regarding HID 10 from NIOSH, CRE submitted a petition directly to the CDC and HHS Chief Information Officers alleging specific failures to comply with OMB Circular A-130 and invoking the "ombudsman" responsibilities of the CIOs under the Circular. CRE believes that this will be a useful test case for identifying specific requirements that should be included in the new rules being developed by OMB and individual agencies under the new data quality legislation.

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    May 21, 2001

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

    Petition for Agency CIO Action on Alleged NIOSH
    Failure to Comply with the Data Quality Requirements
    of OMB Circular A-130 in Connection with Hazard ID No.10

    Dear Mr. Seligman:

    By letter dated May 3, 2001, Dr. Larry Fine responded to our letter of March 9, 2001 concerning data quality issues raised by NIOSH Hazard ID No.10 on worker exposure to pathogens in class B biosolids, particularly issues concerning compliance with OMB Circular A-130 which sets out requirements for agency compliance with the information dissemination provisions of the Paperwork Reduction Act of 1995. While our letter was addressed not only to Dr. Fine, but also to you and OMB’s Office of Information and Regulatory Affairs, which is responsible for overseeing compliance with Circular A-130, the only response we have received is from Dr. Fine. Moreover, Dr. Fine’s response simply indicated a copy sent to you, indicating that you had not been considered to be responsible for, or had even played a lead role in, the response.

    Dr. Fine’s May 3 response stated that the agency believed it had been fully compliant with Circular A-130. However, it did not address any of the specific A-130 issues raised in our letter. His letter indicated that the HID had been peer-reviewed by several scientists outside NIOSH, and it asserted that the HID acknowledged the scientific limitations in the available information, and that its recommendations for minimizing exposures were "consistent with standard public health practice". It also enclosed letters to AMSA and WEF noting their concerns and the recent commencement of a National Research Council study that would address potential pathogenic risks Finally, it indicated a willingness to meet with AMSA and WEF representatives to discuss their concerns, and did not indicate that the agency CIO would act as an ombudsman in resolving the issues.

    Circular A-130 states very clearly that, as set out in our March 9 letter, the agency Chief Information Officer must monitor agency compliance with the Circular, and "must consider alleged instances of agency failure to comply with this Circular", acting as an "ombudsman", and must then "recommend or take appropriate corrective action."1

    To date, the Chief Information Officer responsible for NIOSH has not complied with this portion of the Circular, and it is therefore not possible for CDC to assert that it is fully compliant with the Circular.2 By this letter, we are invoking the responsibilities of the agency CIO to investigate, report on, and mediate this dispute. We wish to meet directly with the CIO on this matter, and we also request that AMSA and WEF be invited to participate in addition to any NIOSH personnel.

    The specific failures by NIOSH to comply with Circular A-130 which we are alleging, in addition to failure to turn the matter over to the agency CIO for consideration and action, are as follows. All or most of these alleged failures have also been asserted in the various AMSA and WEF letters to NIOSH and were indicated with less detail in our March 9 letter.

    1. Lack of prior consultation: Section 6(j) of the Circular requires agencies to "[p]rovide adequate notice when initiating . . . significant information products". This was not done. The HID is obviously a significant information product. This is illustrated by the attention it has received. It is also borne out by the discussion in Appendix IV of the Circular ("Analysis of Key Section", hereafter referred to as "Appendix"3), which gives as one example of significant information products ones that "by reason of the nature of the information, are matters of continuing public interest". AMSA requested such prior consultation in its July 25 letter, prior to the July 28 release of the HID, and also indicated that it had previously requested the opportunity to review drafts; however, NIOSH released the HID before any consultation could be carried out. At this point, it is clear that AMSA’s and CRE’s concerns have still not been adequately addressed, as they should have been during prior consultation.

      Since prior consultation was not carried out, and the HID has since been issued, the only way to remedy this failure to comply is to withdraw the HID until there has been sufficient consultation, together with active intervention by the CIO in response to this petition. While we cannot speak for AMSA, the concerns and alleged failures to comply which should be discussed would include at a minimum those set out briefly below.4

    2. Failure to consider impacts: Related to the above prior consultation requirement is the Circular’s requirement in section 8, a, 1, (b) and (c) that "Agencies will . . . Consider the effects of their actions of members of the public [including State and local governments] and ensure consultation with the public as appropriate." NIOSH has failed almost completely on this point; demonstrating instead an insensitivity to the realities of public perception and arguing, in effect, that certain aspects of the HID are technically correct when considered in proper context or with certain caveats contained in the HID. The fact remains that the HID, simply through its title, labels exposure to Class B biosolids a "hazard" and conveys the impression that the "hazard" is general and widespread, rather than limited to any special circumstances that might have existed at the one small application facility on which the alert is based.5 A headline from a news story on the HID published in the Portsmouth [NH] Herald on August 10 illustrates concisely the public perception impact created by the manner in which the HID is written: "Government says sludge is dangerous". Another example is the July 13 USA Today article which was titled "CDC sounds a warning on sludge risk", which began with a statement that "[w]orkers who handle sludge are especially at risk, scientists found." After considerable urging, NIOSH acknowledged the necessity of issuing a statement pointing out misleading statements in that article.

      NIOSH is obligated to consider how the HID, even if maintained, can be titled and written so as to avoid the realistic likelihood of misperceptions by the public.

    3. Failure to inform the public of limitations: The Appendix to the Circular states:

      Agencies should inform the public as to the limitations in the information dissemination product (e.g., possibility of errors, degree of reliability, and validity) so that users are fully aware of the quality and integrity of the information.

      Dr. Fine’s May 3 letter states that the HID "acknowledges scientific limitation in the available information". While the HID does acknowledge some limitations, it clearly does not sufficiently acknowledge other substantial limitations.

      Perhaps the most important aspect of the HID is that, because it is called simply a "Hazard ID", it give the impression that the HHE on which it was based provided data that could be generalized to all Class B biosolids land application sites, when in fact the HHE is really only a case report rather than a study that was designed to produce generalizable findings.

      One has to read to nearly the bottom of the second page of the HID before finding out that apparently all of the conclusions are based on interviews with five workers and sampling at a single application site. Then there is no discussion as to whether the findings at that particular site provide a sufficient scientific basis for the broad conclusions and recommendations stated in the HID. Although the HID is sprinkled with the words "may", "possibly", and "potential", this vague qualified wording is insufficient acknowledgment of the severe limitations in the data, especially when balanced against encompassing references to "hazard" and "risk" and other more definite statements in the HID -- such as those concerning "risk" being "likely greatest" during and immediately after land application, the statement regarding "prudent public health policy" being sufficient to override lack of data on what constitutes exposure and dose sufficient to induce adverse effects, and the statement that the mere presence of some enteric bacteria in the air is "sufficient justification" for the broad engineering control recommendations. For example, in the case of exposure through the air, there is no indication in the HHE or HID that the five workers had experienced any adverse respiratory effects, and yet this is never acknowledged. There is also no acknowledgment that the highest levels of bacteria were encountered upwind of the storage site. See Table 2, p. 14 of HHE. (In fact, the HHE on which the HID is based states misleadingly that "bacteria concentrations were higher downwind of the sewage sludge pile." At p. 6.) There is further discussion of unacknowledged limitations in the section below on validity and usefulness.

    4. Lack of validity and usefulness (i.e., practical utility): The Circular requires agencies to maximize the usefulness of the information they disseminate. "Usefulness" is equated with "practical utility", as noted in our March 1 letter, and as borne out by the Appendix (discussion of section 8a(8)). Consideration of "practical utility" or "usefulness" requires that the agency take into account "the accuracy, validity, adequacy, and reliability" of information it plans to disseminate. The HID does not reflect that the agency considered these factors, and the HID certainly does not adequately take into account the scientific validity and reliability of the information and recommendations it disseminates. A review of both the HID and the HHE on which it is based reflects that, at a minimum, the following factors seriously undermine, and apparently completely invalidate, the HID and its practical utility:

      • The primary factual basis for the HID – self-reports of five workers at a single site and sampling of the air and the biosolids at that one site – are simply a scientifically inadequate basis for the HID’s extremely broad conclusions and recommendations. Not only is the size of the human and environmental sampling dataset inadequate to support the HID, but there is a recognized potential for significant bias in the type of self-report interviews conducted, particularly when such self-reports were instigated by those doing the self-reporting.

      • Since it appears likely that the five workers failed to follow even the simplest hygiene procedures (e.g., use of gloves and hand washing) – something which becomes clear only on close reading of the HHE rather than the HID – it is not possible to conclude that the recommendations for engineering controls are justified.

      • There is no indication that the actual exposures to workers resulting from the biosolids were any higher than those routinely encountered in situations such as livestock operations and POTWs where no adverse health effects have been reported. As noted previously, the highest air sampling readings were actually encountered upwind of the storage site.

      • The statement in the HID that it is "prudent public health policy" to minimize worker exposure to the greatest extent possible even when it is not known whether they are exposed to a level of bacteria sufficient to induce adverse health effects is unfounded. Prudent public health policy attempts to take into account the extent of actual risk (vs. hazard) and balances any such risk against beneficial uses and workers’ willingness to expose themselves voluntarily to some limited risk of minor and transient adverse effects. There is no all-encompassing public health principle that dictates that all conceivable measures be taken to minimize every theoretical and minor health or safety risk. Moreover, the HID as a whole gives the impression that it is scientifically based, rather than policy based, which is misleading.

      • There is no information provided as to whether the occurrences of mild gastrointestinal disturbances (lasting 5 to 10 hours) self-reported by the five workers were unusual in frequency or severity in comparison with the general population.

    5. Lack of need for the HID: Under the Circular, agencies must "[a]ssure that information dissemination products are necessary for proper performance of agency functions." The Appendix explains that this portion of the Circular is the equivalent to the statutory requirement that information dissemination products must be "necessary in the transaction of the public business required by law of the agency", and that agencies should determine systematically the need for each information dissemination product." Not only is the HID lacking in validity and reliability, as discussed above, thereby making it unnecessary because it cannot be determined to satisfy the "usefulness" and "practical utility" requirements; but it also was not issued in order to satisfy any agency statutory responsibility, nor is there any indication that the agency made a determination of need.

      The statutory provisions conferring authority and duties on NIOSH do not appear to impose any requirements on NIOSH that would make such an HID necessary. 29 USC sec. 669(d) covers "Dissemination of information to interested parties." Those provisions cover only dissemination of information obtained under section 669 "to employers and employees and organizations thereof." This provision appears to refer to subsection (a)(6) of section 669 which pertains only to investigations of conditions at a specific site to determine "whether any substance normally found in the place of employment has potentially toxic effects in such concentrations as used or found, and [submission of] such determination both to employers and affected employees as soon as possible." There is no provision giving NIOSH responsibility for disseminating to the general public industry-wide recommendations for protective measures based on information obtained from a site-specific investigation. Additionally, this particular HID does not sufficiently relate potentially toxic effects to "such concentrations as used or found" at the Ohio site that was investigated.

      As noted previously, the Circular requirement for determination of need for an information dissemination product overlap to some extent with the requirements for "practical utility"/"validity", since information without practical utility/validity serves no useful purpose.

    We believe that the above allegations of failure to comply with the Circular are sufficient to invoke the authority and responsibility of the agency CIO to investigate, mediate, and take or recommend action. We also believe that they are sufficient to make out a prima facie case for withdrawing the HID pending such further review, particularly considering the failure to conduct the required pre-release consultation.

    A March 21 letter by Dr. Fine enclosed with his May 3 letter notes that the National Research Council is conducting a study that will encompass potential risks from pathogens in Class B biosolids that should provide additional pertinent information. We agree that the NRC study is pertinent. At the initial meeting of the NRC study committee there was extensive comment on and discussion of the NIOSH HID. Some committee members indicated concerns with the HID similar or identical to those listed here. We believe that it would be prudent, if not necessary, for NIOSH to await the results of the NRC study before considering release of any HID containing industry-wide recommendations for worker protection from Class B biosolids.

    We look forward to your convening a meeting with CRE and the other parties who have indicated similar concerns in order to investigate and resolve these issues. In order that we might be thoroughly prepared for such a meeting, we request that the agency provide us with copies of the peer review comments referred to in Dr. Fine’s May 3 letter, as well as any additional external comments (other than those sent by AMSA and WEF).


    Jim J. Tozzi
    Member, CRE Board of Advisors

    cc: HHS Acting CIO Dennis Williams
    HHS Deputy CIO Brian Burns
    OMB Office of Information and Regulatory Affairs

    1. An "ombudsman" is generally defined as "a person who investigates complaints, reports findings, and mediates fair settlements, especially between aggrieved parties." American Heritage Dictionary.

    2. Dr. Fine’s May 3 letter states that NIOSH believes it was fully compliant with the Circular "in releasing" the HID; but, it does not address CRE’s allegations of post-release failure to comply and the duties of the CIO. CRE also disagrees that the agency was fully compliant at the time of release, as discussed below.

    3. The references to the Circular in the Appendix do not appear to correspond exactly to the revisions published November 30, 2000.

    4. This letter contains only a summary of the failures to comply which we believe is sufficient to justify invocation of the CIO’s ombudsman responsibilities.. We expect to provide additional details and discussion in our meeting(s) with the CIO and any additional personnel. In addition to AMSA, WEF and NEBRA have expressed serious concerns with the HID, and they should be involved in discussions regarding the allegations of failures to comply with Circular A-130 set out here.

    5. It is likely that very few members of the public appreciate the important distinction between "hazard" and "risk". It is not even clear from the HID that NIOSH appreciates the distinction.