U.S. EPA Proposes Rule That Would Transform the Guidance Process
On May 19, 2020, in an effort to curtail the growth in guidance documents, U.S. EPA proposed new rules to reign in and formalize the guidance process. This proposal resulted from an October 15, 2019 Executive Order that acknowledged the growth in agency use of non-binding guidance to regulate without following formal rulemaking procedures.
In the proposal, U.S. EPA affirms that guidance documents are not legally binding and are intended only to provide clarification and information to the regulated community on existing statutory and regulatory requirements. Guidance is not intended to create new or additional requirements or limit interpretations of the applicable statutes or rules.
Key takeaways of the proposed rules are:
U.S. EPA, in conformance with the Executive Order, will place current guidance on a searchable website. Guidance not on the website by June 27, 2020 is considered “rescinded” and may not be relied upon.
U.S. EPA will make a distinction between “guidance documents” and “significant guidance documents,” with significant guidance documents required to go through notice and comment.
Modification or withdrawal of active guidance can be sought by regulated entities, which may lead to litigation over the decision to accept or deny the modification/withdrawal request.
The use of guidance as a substitute for rules (and now the creation of rules to govern guidance) potentially creates more confusion and “traps for the unwary” than helpful direction. For example, in the complex air program, volumes of guidance already exist, and the guidance may or may not be used by states or states with delegated authority may only apply federal guidance to certain situations and not others. All of this undercuts the intent and usefulness of guidance, which is to assist the regulated community to comply with complicated and overlapping rules.
Rather than rely on the shifting sands of guidance, businesses can create certainty by aggressively using the applicability determination process to create binding written decisions that can be relied upon and, even in the air context, be incorporated into Title V permits. This process can help create the certainty sought by regulated entities by avoiding the legal uncertainties and now a layer of potential procedural confusion that may be associated with the new “guidance.”