The White House released a draft bulletin on the day before Thanksgiving that establishes new guidelines for non-rulemaking agency guidance documents.

The proposed bulletin from the Office of Information and Regulatory Affairs (OIRA) within the White House's Office of Management and Budget (OMB) establishes what it calls "good guidance practices" for the content, development, and revision of guidance documents.

The term "guidance documents" generally refers to a wide range of materials used by agencies to clarify or articulate information or further explain regulatory requirements. Guidance documents can include compliance guides that explain how a regulation applies to an industry sector in sector-specific terms, supplemental materials that assist companies preparing applications for agency approval, and much more. Guidance documents are not subject to the procedural requirements that apply to rulemakings, such as the Administrative Procedure Act and Executive Order 12,866.

About the OIRA Bulletin

In an attempt to make guidance documents "more transparent, consistent and accountable," the new draft bulletin provides guidelines for a class of guidance documents deemed "significant guidance documents," including requiring approval by senior agency officials for new significant guidance documents, creating standards for the content of guidance documents, and increasing transparency and public comments.

Significant Guidance Documents

The draft defines a broad range of documents as significant guidance document, including the following:

• documents that "raise highly controversial issues related to interagency concerns or important Administration priorities";
• guidance documents that establish "initial interpretations of statutory or regulatory requirements" or announce changes in such interpretations; and
• documents detailing "novel or complex scientific or technical issues."

An additional subset of significant guidance documents are economically significant guidance documents, defined as those that are "[r]easonably anticipated to lead to an annual effect of $100 million or more or adversely affect in a material way the economy or a sector of the economy." It is unclear, however, how a guidance document, which is not legally enforceable, could have an economic impact.

The bulletin proposes a number of exclusions, such as "contractor instructions," litigation and other legal documents, scholarly articles, interagency memoranda of understanding, media relations, and "warning letters." The definition section of the bulletin does not specifically exempt other documents used in enforcement actions, but a later section clarifies that the bulletin does not "in any way affect [agencies'] authority to communicate their views in court or other enforcement proceedings."

New Requirements

The OIRA bulletin calls for new requirements to apply to all significant guidance documents:

• Review and Approval: The draft bulletin requires that agencies establish procedures requiring the review of significant guidance documents by senior agency staff.
• Content: The draft also established content requirements, such as restricting the use of words that suggest mandatory duties and standardizing guidance documents by including the date, agency, docket number and other relevant information.
• Transparency: Agencies are also required to make significant guidance documents publicly available on the Internet and compile a yearly list of all significant guidance documents.
• Public Participation: Agencies are also required to develop a means for receiving public comment on guidance documents, including requests for review or modification of existing guidance documents or proposals for new guidance documents. The draft bulletin makes clear that agencies do not have to respond to public requests, as the comments would be strictly "for the benefit of the agency." There is, at least not in the current draft of the bulletin, no burdensome equivalent of the procedures related to the Data Quality Act provision for guidance documents, which can be misused by industry to delay the issuance of guidance or derail an agency's priorities.

The guidance makes clear that despite the notice-and-comment requirements, guidance documents are still not legally enforceable.

The draft bulletin requires additional procedures when an agency is preparing a draft economically significant guidance document. In such cases, the agency will be required to publish the draft guidance in the Federal Register, invite public comments, and formally respond to the comments.

The bulletin insists that agencies must not avoid the new "good guidance practices" by communicating guidance in forms that escape the bulletin's reach, but it does permit agencies--"in consultation with OMB"--to identify specific guidance documents or entire classes of guidance documents that should be exempted from the new policy.

Next Steps

The proposed bulletin is now open for public comment through Dec. 23.

Public interest groups will likely approach the bulletin with some healthy skepticism. On the one hand, respected bodies such as the Administrative Conference of the United States (ACUS) have called for similar good guidance practices (although the two ACUS recommendations suggested leaving matters up to the agencies without requiring any decisions be made "in consultation with" OIRA). The Bush administration’s pattern of failure to develop new protective standards has been aided, in part, by some agencies' use of non-binding, voluntary guidance instead of real protective standards that apply across the board to ensure the public's protection.

On the other hand, corporate-conservative anti-regulatory discourse has aggressively promoted a vision of "regulation by information" as a "problem" in need of correction by such cumbersome overlays as the Data Quality Act and OIRA's peer review guidelines.

InsideEPA (subscription-only) reported that EPA sources expressed concern that the good guidance practices would delay agency's ability to issue new guidance documents, particularly "new risk assessments for controversial chemicals in a major agency risk database known as the Integrated Risk Information System," as well as clean air and drinking water advisories.

It is not clear, however, if the criticism of agency insiders is based on the new notice-and-comment requirements or on the perception that the draft bulletin would increase OMB's review of agency rules. According to the draft bulletin, OMB would not review guidance documents; rather, agencies would develop internal procedures for senior staff to review significant guidance documents.