Summary
Stakeholders in the regulated community have a unique but time-limited opportunity to petition the U.S. Environmental Protection Agency (EPA) and other federal agencies to either add or remove specific guidance documents from their respective online portals. The Trump Administration has instructed each agency to ensure that, by June 27, these portals contain all guidance documents currently in effect. Going forward, agencies may not cite, use, or rely on any guidance that is not posted in their portals, except to establish historical facts. As discussed further below, this deadline stems from Executive Order 13891 (EO) issued by President Trump on October 9, 2019 entitled "Promoting the Rule of Law Through Improved Agency Guidance Documents."
Practical Implications and Action Items for Industry
Guidance documents frequently present a double-edged sword for industry and other stakeholders. On the one hand, where statutes and regulations are unclear, guidance documents often help flesh out compliance obligations and provide the regulated community with certainty regarding an agency’s interpretation of the law. On the other hand, as the EO states, guidance is often highly influential and relied upon by EPA, other environmental agencies throughout the world, and state regulatory agencies, but it bypasses public comment that would be required for rulemakings.
Because the use of guidance varies widely at EPA and other agencies, there does not appear to be a "one size fits all" strategy that all companies should pursue in addressing the EO and EPA rulemaking implementing it. However, here are some steps that can be taken to assess this evolving policy’s impact:
- Evaluate whether a particular document is "guidance" in the first place. The EO defines guidance as an agency statement of general applicability, intended to have future effect on statutory, regulatory, or technical issues, or an interpretation of a statute or regulation, with identified exceptions. The Office of Management and Budget (OMB) issued a memorandum on October 31, 2019 in which it stated that "guidance" excludes advisory or legal opinions directed to particular parties and other location- or fact-specific discussions. But the line between "guidance" and a fact-specific opinion is unclear. OMB also considers as guidance a document ostensibly directed to a particular party but designed to guide the conduct of the broader regulated public. EPA’s proposed rule (not yet in the Federal Register) does not clarify the issue, and looks at whether a document is intended to have a substantial effect on regulated parties.
- Identify key guidance documents that your company or trade association relies, or has relied, upon to support important environmental compliance strategies, and determine whether EPA (or other agencies) has included those documents in its Portal. This may be a big job and identifying every important document may not be feasible.
- Comment to EPA and other agencies regarding ambiguities that need to be resolved in the response to the EO, including:
a. What is the agency’s process for determining which documents are "guidance" and which are not?
b. Consider commenting on the proposed EPA rulemaking that would limit the agency’s latitude to issue guidance. There may be differing views in the regulated community here. Some companies may argue that less guidance is the better result. Other companies may welcome guidance as an efficient way of obtaining some level of certainty where regulations or statutes are ambiguous.
c. What happens to all of the existing documents (guidance or not) that are not in the Portal? Will there continue to be a repository for those documents outside of the Portal?
d. How is the agency determining which guidance has been rescinded or superseded? If a guidance document is not in the Portal, does it mean that the agency has determined that it is rescinded or superseded?
- Petition EPA to withdraw specific guidance documents that are no longer appropriate for Agency reliance. Some guidance is specifically superseded (e.g., the CAA Section 112 "Once in Always In" guidance). Other guidance may no longer be relevant or have been overtaken by later developments, though not specifically superseded. If you are aware of such guidance, you can ask EPA or other agencies to withdraw the no longer appropriate guidance. This may be done through the Portal itself.
- Petition EPA to add specific guidance documents. The webpage for petitioning for withdrawal or modification of guidance documents already in the Portal is apparently not intended to allow petitions for inclusion of guidance documents not already in the Portal. It has no way to attach or upload documents. As a result, it may be advisable to submit an email request to add guidance documents to the specific EPA Office.
- Consider the status of key guidance issued by other federal agencies. Other federal agencies have taken varying approaches as they implement the EO. For example, the U.S. Fish and Wildlife Service (FWS) and U.S. Department of Transportation (DOT) have each created a searchable database that provides an opportunity for members of the public to make additional suggestions via email. The U.S. Department of Agriculture (USDA) has taken a more minimalist approach, providing a list of links to other USDA service websites. By contrast, the U.S. Food and Drug Administration (FDA) has long maintained its own robust guidance database and has not, to date, indicated any changes to its historic practice related to the EO. Stakeholders should determine whether relevant documents have been included in these and other federal agency portals, and consider taking action if any omissions are identified.
Why are agencies developing their guidance portals now?
On October 9, 2019, President Trump issued the EO. The EO is critical of agency use of guidance. Specifically, it criticizes guidance because it "attempts to regulate the public without following the rulemaking procedures of the [Administrative Procedure Act]." Calling on agencies to treat guidance documents as non-binding both in law and in practice, and to make guidance documents readily available to the public, the EO ordered OMB to issue a memorandum requiring each agency to establish a single, searchable, indexed database (a "Portal") that contains all guidance documents in effect.
OMB issued that memorandum on October 31, 2019. To comply, each agency of the federal government must, in turn, review all of its guidance documents and rescind those guidance documents it determines should no longer be in effect. An agency cannot retain any guidance document in effect after June 27 unless it is in that agency’s Portal, and agencies must include all future guidance documents in the Portal. Most critically for the regulated community, the EO states that "No agency may cite, use, or rely on guidance documents that are rescinded except to establish historical facts."
What action is EPA taking to Implement the EO?
EPA has established its Portal, available here. The Portal is organized by Office and is searchable. It already contains thousands of documents. The website advises that “the Agency is continuing to inventory guidance documents and anticipates providing updates prior to June 27, 2020.”
EPA proposed a rule to implement the Executive Order on May 19. That proposal has not yet been published in the Federal Register, but upon publication, parties will have only 30 days to comment on it. Meanwhile, each EPA office – e.g., the Office of Water, the Office of Air and Radiation, the Office of Enforcement and Compliance Assurance – is determining how to comply with the EO by evaluating which documents meet the definition of "guidance," and which guidance should be included in its Portal. Any serious review would involve thousands of documents. EPA and other agencies must post all guidance documents to the Portal by June 27. As noted above, now is the time to engage with EPA if your company or industry relies on guidance documents and wishes to advocate to EPA to retain them, or, conversely, to advocate that EPA should remove certain guidance documents.
[View source.]
