When Is a Guidance Document a Rule Change?

By Cheryl Bolen

June 30 — A bipartisan pair of senators is looking to solve a complex policy equation that would allow federal agencies to issue true guidance documents for clarity, but prevent them from making substantive rule changes—all without undue delay.

Guidance is one of the most common ways that federal agencies communicate to stakeholders, yet it receives little congressional oversight, despite the propensity of agencies to use guidance to enact rule changes, the senators said.

“What is guidance?” asked Sen. James Lankford (R-Okla.), the chairman of the Senate Homeland Security and Governmental Affairs Subcommittee on Regulatory Affairs and Federal Management, at a hearing to examine agency use of guidance.

Guidance documents, which are not legally binding—but are often treated as such—are exempt from the Administrative Procedure Act requirements that apply to agency rulemakings, such as public notice and comment.

Bedeviling Definition

Senators on both sides of the aisle would support clear deadlines, boundaries and definitions, Lankford said at the second of two hearings into agency guidance (See previous story, 09/24/15).

Sen. Heidi Heitkamp (D-N.D.), the ranking member of the subcommittee, said they had seen “significant changes” made to rules through guidance documents.

It is one thing to interpret a rule or statute to provide clarity, but another to turn policy and enforcement in the opposite direction, and the challenge is figuring out how to differentiate between the two, Heitkamp said.

“If there's a proper review process and the agency really intends to follow the rules of the road, that should be pretty clear,” said Paul Noe, vice president of public policy at the American Forest & Paper Association and American Wood Council.

Apply Notice and Comment?

One idea debated by the subcommittee would be to add a public notice and comment requirement to guidance documents.

“I think affected parties should have an opportunity to be able to raise their hand and say, ‘Have you thought about that?' before [guidance] goes in,” Lankford said.

Noe also argued in favor of having a notice and comment requirement for issuing guidance. Even in an emergency situation, an agency could issue an interpretation, but still take comments in case the agency got it wrong, he said.

Concerns With Approach

Amit Narang, regulatory policy advocate at Public Citizen, said he had no concerns about agencies instituting different processes for guidance documents at their own discretion, as the Food and Drug Administration has done.

However, Narang questioned whether the approach such as the one adopted by the FDA is the right approach for all agencies. “One-size-fits-all approaches normally result in unintended consequences,” he said.

Moreover, if Congress were to essentially create a longer process for guidance documents that resembled notice-and-comment rulemaking, but kept those guidance documents nonbinding, then agencies would have no incentive to issue guidance, he said.

To contact the reporter on this story: Cheryl Bolen in Washington at cbolen@bna.com

To contact the editor responsible for this story: Heather Rothman at hrothman@bna.com

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