crossposted from unbossed
In recent years we got used to news that the Bush administration had used regulations and the regulatory process to do end runs around Congress . . . well, and the American people. One of the most important players was the Office of Information and Regulatory Affairs (OIRA) - an organization that used its oversight in what seemed to be endless nefarious ways. Here is a brief walk down OIRA memory lane, as seen by unbossed, for those who want to go there.
Today GAO released a report dated April 20, usually an indication of some "issues" with a study's content and recommendations. The report itself, a case study of the time and issues related to the promulgation of a rule, seems uncontroversial and a good idea. But, there are bodies buried in that terrain.
Clearly, the GAO is concerned about the role OIRA has played. It gives an example of the way OIRA has played fast and loose with its power.
OIRA’s reviews of agencies’ draft rules often resulted in changes to the rules, but there are opportunities to improve the transparency of OIRA’s reviews. OIRA reviewed 12 of our 16 case-study rules under Executive Order 12866; SEC’s rules are not reviewed by OIRA. OIRA’s reviews resulted in changes to 10 of the 12 rules. Further, we determined that changes to 4 of the rules (1 DOT, 2 EPA, and 1 FDA) were significant in that they included changes to the regulatory text of the rule. For example, one change to the draft text of a FDA rule on dietary supplements reduced the requirement to save reserve samples from 3 years to 2 years.
Here is more detail from the report on the signifcance of the changes and the process itself involved with the regulation on dietary substances.
FDA made changes at the suggestion of OIRA to both the preamble and the regulatory text. FDA sent draft versions of the final rule to OIRA twice, once in October 2005 and again in June 2006. FDA staff stated that the rule was not returned by OIRA, but rather as a result of discussions, FDA staff made a number of changes and sent a second draft of the rule to OIRA. Our review of both copies of the draft final rule reviewed by OIRA as docketed by FDA found edits to the rule, both to the preamble and the rule itself. For example, in addition to editorial changes, changes to the draft rule text show that a requirement in the rule to save reserve samples for 3 years was changed to 2 years. This change is also reflected in the preamble language. Changes to the regulatory impact analysis—included with the rule in its entirety in keeping with FDA practice—show additions of text justifying the rulemaking and additional descriptions of calculations of costs associated with illness and injury resulting from contaminated or mislabeled dietary supplements. We found documentation of the final stage of OMB review on both drafts sent to OMB during that stage.
It is no wonder, then, that among its recommendations are these directed at understanding what OIRA has been doing.
If the current administration retains Executive Order 12866, or establishes similar transparency requirements, we recommend that the Director of OMB, through the Administrator of OIRA, take the following four actions to more consistently implement the order’s requirement to provide information to the public "in a complete, clear, and simple manner":
• define in guidance what types of changes made as a result of the OIRA review process are substantive and need to be publicly identified,
• instruct agencies to clearly attribute those changes "made at the suggestion or recommendation of OIRA,"
• direct agencies to clearly state in final rules whether they made substantive changes as a result of the OIRA reviews, and
• standardize how agencies label documentation of these changes in public rulemaking dockets.
On page 36 of the report, GAO notes that since 2003 OIRA has only implemented one of eight recommendations made by GAO to improve the level of information available to the public on the process of regulation and OIRA's role in specific. Here is the report section on this issue.
In our 2003 report on the OMB/OIRA regulatory review process, we made eight recommendations to the Director of OMB to improve the transparency of the process.42 OMB implemented our recommendation to improve the clarity of OIRA’s meeting log to better identify participants in OMB meetings with external parties on rules under review by disclosing the affiliations of participants. In some cases, the log also identified the clients represented.
However, OIRA did not agree with the seven remaining recommendations in the 2003 report and did not implement those recommendations. We recommended that OIRA should do the following:
- Define the transparency requirements applicable to the agencies and OIRA in Executive Order 12866 in such a way that they include not only the formal review period, but also the informal review period when OIRA says it can have its most important impact on agencies’ rules.
- Change OIRA’s database to clearly differentiate within the "consistent with change" outcome category which rules were substantively changed at OIRA’s suggestion or recommendation and which were changed in other ways and for other reasons.
- Reexamine OIRA’s current policy that only documents exchanged by OIRA branch chiefs and above need to be disclosed because most of the documents that are exchanged while rules are under review at OIRA are exchanged between agency staff and OIRA desk officers.
- Establish procedures whereby either OIRA or the agencies disclose the reason why rules are withdrawn from OIRA review.
- Define the types of "substantive" changes during the OIRA review process that agencies should disclose as including not only changes made to the regulatory text but also other, noneditorial changes that could ultimately affect the rules’ application (for example, explanations supporting the choice of one alternative over another and solicitations of comments on the estimated benefits and costs of regulatory options).
- Instruct agencies to put information about changes made in a rule after submission for OIRA’s review and those made at OIRA’s suggestion or recommendation in the agencies’ public rulemaking dockets, and to do so within a reasonable period after the rules have been published.
- Encourage agencies to use "best practice" methods of documentation that clearly describe those changes.
We discussed the status of these open recommendations with OIRA representatives annually since 2003 and also as part of this review, and they confirmed that OIRA had not subsequently implemented any of the seven remaining recommendations. As discussed above, our current review indicated that there are still opportunities to improve transparency for some of these topics, such as better identification of when agencies made substantive changes to their rules as a result of the OIRA review process, attributing the sources of changes made during the review period, and clarifying the definition of substantive changes.
My comment at the beginning that the delayed release shows some behind the scenes wrangling was in fact the case. I don't know when I've seen such a testy statement of events after the report was circulated to affected parties. Here is part of the GAO's statement on those reactions:
We provided a draft of this report to the Department of Health and Human Services (HHS), DOT, EPA, SEC, and OMB. We received written comments from HHS/FDA, EPA, SEC, and OMB which are summarized below and reprinted in appendices IV through VII. However, because EPA and FDA provided new information as part of agency comments, we did not analyze the information provided and conduct follow-up discussions with agency officials prior to publication of this report. We note that we had asked for this information during our review and the agencies did not provide at that time. Also, they did not provide this information at the conclusion of our review either in response to our statements of facts to the agencies or at our exit conference with the agencies. DOT provided only technical comments. With regard to the two recommendations directed to the rulemaking agencies, SEC stated that the Commission is committed to evaluating and improving all of it processes and will consider our recommendations as part of that process.
GAO goes on to say that FDA was demanding limits on review - limits that GAO said would remove from review about 85% of regulations.
This is a very long and detailed report and is recommended reading by reg wonks.
Federal Rulemaking: Improvements Needed to Monitoring and Evaluation of Rules Development as Well as to the Transparency of OMB Regulatory Reviews GAO-09-205, April 20, 2009 but released May 11, 2009.