When Guidance Becomes Rule

Guidance Becomes Rule

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agency, complications may rise when these documents are not updated or where references included in those documents are out of date.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.

 

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What Makes a Guidance Great

 

The environmental science and remediation industry is chock-full of guidance documents. Some are wonderful resources, while others are a colossal waste of time. Some pass rigorous peer review processes prior to publication, while others are written in a vacuum. Whether you are reviewing one, learning from one or getting ready to participate in the creation of one, there are important fundamental concepts to consider in what makes one great. Every great guidance document shares the following qualities:

  1. The audience and purpose are clear
  2. The significance is clear and concise
  3. There is a current “go to” resource
  4. There is wide range acceptance or concurrence

Team - Guidance document

Clear Intentions to Audience

A user of any guidance should know within the first couple pages, if not by title, if the guidance is intended for him/her and what the purpose is. Generally, there are three primary purposes of guidance:

  1. To Inform a general audience by compiling multiple ideas, publications and research work into one concise document
  2. To Standardize a set of practices to reduce inconsistent behavior between practitioners
  3. To Regulate the user by either providing clarity or expanding regulatory language or by being incorporated into law

As you can imagine, the three categories listed above are not listed by importance. Informational documents are somewhat flexible in their usage while those that are referenced by law are not.

 

Significance

The resources which go into developing guidance documents are sometimes astounding. I have estimated the costs of human time, travel, and resources on a key industry document for which I had a leadership role and my estimate was very near $900,000. I was probably low. With this amount of resources, the whole project should start with the conversation of significance. Then, make sure the concept stays throughout the document in a very concise manner. The significance is simply why the document is important and what problem it is trying to solve.

 

Current “Go To” Resource

Many of the great guidance documents have that one set of tables, charts, figures, appendices, or matrices that make it a great resource. You pick them back up knowing exactly where you are going to go in it. The bad ones you look at as 100 pages of words and just go “ugh”. The resource also must be current or the user must know if the material has the potential to be out of date.

Graph - Guidance Document
Relevant and useful figures make a big difference in the quality of a resource.

 

Concurrence

Acceptance of a guidance document comes in many forms. Many industry leaders use Standard Development Organizations (SDOs), such as ASTM or ANSI, as an avenue for publishing guidance due to their rigorous concurrence procedures, such as balanced voting. Concurrence may also come in far less formal and less timely methods. For example, a guidance may be written by a state agency or small work group and become accepted industry wide simply based on use and word of mouth. This form of concurrence may take months or years following publication. An example may be a new, innovative but controversial guidance that takes years to “catch on.”

 

Take Home Message

Understanding the criteria listed above will help any user understand the applicability of an industry guidance document. More importantly, if starting one, this list provides a good starting point from which to base future discussions.

 

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