Responding to President Donald Trump’s Executive Order (EO) 13891, as well as instructions from the White House Office of Information and Regulatory Affairs (OIRA) on how to comply with the EO, the EPA has proposed regulations specifying how the Agency will manage the issuance and administration of guidance documents. The proposal would define guidance documents and significant guidance documents and establish a procedure to allow the public to participate in the development of significant guidance documents. Also, a process for the public to petition the Agency to modify or withdraw an active guidance document would be established. In addition, the proposal would require that the EPA maintain an Internet portal with all the Agency’s active and effective guidance. The EPA has already established the guidance document portal; the portal would be codified upon finalization of the proposal.

The EPA states that the purpose of its proposal is to “ensure that the EPA's guidance documents are developed with appropriate review and are accessible and transparent to the public and that the public is provided the opportunity to participate in the development of significant guidance documents.”

“Today’s action is a major step toward increasing transparency in EPA processes and ensuring that EPA is not creating new regulatory obligations through guidance,” said EPA Administrator Andrew Wheeler in a statement.

Impact can be deep

Guidance documents issued by federal agencies take a number of forms, including interpretive memoranda, policy statements, manuals, bulletins, and advisories. Agencies often publish guidance documents to clarify regulations and promote timely compliance. One advantage of guidance documents is that they do not have to undergo the formal rulemaking process specified in the Administrative Procedures Act (APA) and therefore can be put into use much faster than a formal rule or rule amendment.

The OIRA instructions note that some guidance documents are routine or ministerial and have limited impact on the public. However, other documents, which in the proposal the EPA lists under the general term guidance documents, constitute the Agency’s “statement of general applicability, intended to have future effect on the behavior of regulated parties, that sets forth a policy on a statutory, regulatory, or technical issue, or an interpretation of a statute or regulation.” Moreover, the proposal also defines significant guidance documents as those that may have extensive impacts, including an annual effect on the economy of $100 million or more; be inconsistent or interfere with an action taken or planned by another agency; or give rise to novel legal or policy issues.

De facto regulations

For many years, the EPA has made extensive use of all types of guidance documents, perhaps more so than any other federal agency. The Trump EPA has by no means avoided guidance documents. One commenter on the proposal noted that under Trump, the Office of Air and Radiation alone has issued 132 guidance documents. In commenting—favorably—on the proposal, Rep. James Comer (R-KY), a member of the House Oversight and Government Reform Committee, notes that the Agency has already deposited 9,000 guidance documents in its portal.

The EO addressed the concern that agencies have used guidance documents to impose new compliance responsibilities on the public. Stakeholders regularly complain that the EPA is particularly inclined toward using guidance documents in this way. Because guidance documents are not subject to the APA, they can be issued without undergoing the notice-and-comment process. In other words, the regulated community may be compelled to comply with guidance documents that are de facto “regulations” without ever having the opportunity to exercise its legal right to raise concerns about why such requirements are unnecessary or not practical, cost-effective, or even legal.

Withdrawal petitions

In addition to codification of the guidance document portal, the EPA is proposing the following:

• General requirements and procedures for issuing all guidance documents. The requirements include identifying the general activities to which and the persons to whom the document applies. Also, the EPA would be required to include in the guidance document a disclaimer stating that the contents of the document do not have the force and effect of law and that the Agency does not intend to bind the public in any way and intends only to provide clarity regarding existing requirements under the law or Agency policies. If the guidance document is binding because it is authorized by law or because the guidance is incorporated into a contract, the EPA will make that clear in the document.
• Requirements for issuing significant guidance documents. The proposal includes a public review-and-comment opportunity for all significant guidance documents, whether the documents are new or a modification or withdrawal of an active guidance document. This requirement would not apply in cases when the EPA determines that the document is necessary because of a public health, safety, environment, or other emergency. As with significant regulations, the EPA would be required to assess the potential impact of a significant guidance document if those effects may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more.
• Procedures for the public to petition for modification or withdrawal. The proposal specifies the format and content elements for such petitions, including a rationale for the requested modification or withdrawal. The EPA would be required to respond to petitions in a timely manner but no later than 90 calendar days after receipt of the petition.