Agency Guidance Practices for Civil Engineering

Basic considerations

Beneficial Outcomes

Well-designed guidance documents serve many important or even critical functions in Federal regulatory programs:

• Agencies may provide helpful guidance to interpret existing law through an interpretive rule or to clarify how they tentatively will treat or enforce a governing legal norm through a policy statement.
• Guidance documents, used properly, can channel the discretion of agency employees, increase efficiency, and enhance fairness by providing the public clear notice of the line between permissible and impermissible conduct while ensuring equal treatment of similarly situated parties. [1]

Regulatory framework for Engineering Guidance

US Office of Management and Budget (OMB) Policy guidance

OMB's objective was to ensure that agency guidance practices be more transparent, consistent and accountable. [2] The agency noted that:

"Because it is procedurally easier to issue guidance documents, there also may be an incentive for regulators to issue guidance documents in lieu of regulations."

A judicial comment put this concern in context:

> "Congress passes a broadly worded statute. The agency follows with regulations containing broad language, open-ended phrases, ambiguous standards and the like. Then as years pass, the agency issues circulars or guidance or memoranda, explaining, interpreting, defining and often expanding the commands in regulations. One guidance document may yield another and then another and so on. Several words in a regulation may spawn hundreds of pages of text as the agency offers more and more detail regarding what its regulations demand of regulated entities. Law is made, without notice and comment, without public participation, and without publication in the Federal Register or the Code of Federal Regulations." [3]

Working definition of the term

Guidance documents often come in a variety of formats and names, including interpretive memoranda, policy statements, guidances, manuals, circulars, memoranda, bulletins, advisories, and the like.

Guidance documents include, but are not limited to, agency interpretations or policies that relate to: the design, production, manufacturing, control, remediation, testing, analysis or assessment of products and substances, and the processing, content, and evaluation/approval of submissions or applications, as well as compliance guides.

Guidance documents do not include solely scientific research. Although a document that simply summarizes the protocol and conclusions of a specific research project (such as a clinical trial funded by the National Institutes of Health) would not qualify as a guidance document, such research may be the basis of a guidance.

Limitations of the definition

One important distinction in this process of issuing guidance is its distinction from rule-making.

OMB's 2007 bulletin in Section I(3) defined the term "guidance document" as an agency statement of general applicability and future effect, other than a regulatory action, that sets forth a policy on a statutory, regulatory, or technical issue, or an interpretation of a statutory or regulatory issue. The bulletin's definition of “guidance document” encompasses all guidance materials, regardless of format. [4]

• The intent of OMB's bulletin (itself the subject of a regulatory rule-making) was to make clear that a guidance document cannot impose a legally binding requirement. [5]

See also

• Guidance Practices

References

1. Final Bulletin for Agency Good Guidance Practices, US Office of Management and Budget (OMB), Bulletin No. 07-02, 2007.
2. 2007, OMB, op. cit.
3. Judicial comment from Appalachian Power, 208 F.3d at 1019, cited by OMB at p. 3, op. cit.
4. 2007, OMB, ibid., p. 7.
5. 2007, OMB, ibid., p. 6.