I outlined before what makes a great guidance document, but that doesn’t automatically make the guidance a rule.
Guidance documents which standardize a set of procedures are typically not only relevant, but may even be required by policy or law. Federal law and policies, such as the Office of Management and Budget Circular A-119 (revised January 2016), even require federal agencies to refer to standards by “incorporation by reference” rather than recreating the material in federal code. In such cases, these “Voluntary Consensus Standards (VCS)” become law. A-119 expands not only on the federal government’s reliance on VCSs, but also encourages participation in the development process. A-119 also requires that VCS’s which are incorporated by reference be developed in an open and balanced system and be considered for the costs associated with accessing the documents. Some standard development organizations, such as ASTM, have made available such referenced standards free to the public.
State and local regulatory agencies may also rely on industry guidance documents in their corresponding regulations. Most do not have policies or procedures regarding incorporation by reference, so it is imperative that these documents be reviewed during promulgation or when the public has an opportunity to review and comment. Regardless of the referring agency, complications may rise when these documents are not updated or where references included in those documents are out of date.
Finally, industry guidance may be written to support federal, state or local regulation but not necessarily referenced in the regulation. These may be state guidance documents, industry documents, or even peer-reviewed journals. Although not rule by reference, these documents sometimes become the “common law” simply by widespread industry acceptance. Users of these documents should be aware of their limitations, the process in which they were created and the frequency in which they are updated. Although useful for potentially predictive outcomes, these documents may be flexible and or open to challenge.
Guidance becomes the rule when either regulatory agencies refer to them in such a way or when widespread acceptance makes them the norm.