The EPA has issued a rule requiring all significant agency guidance to undergo a public notice and comment process prior to issuance, modification or withdrawal (Rule). The new Rule was adopted pursuant to Executive Order 13891, which also required the agency to distinguish active guidance from inactive guidance, and to limit documents available through the official EPA guidance portal (Order). As of June 27, 2020 only guidance available through the official agency guidance portals qualifies as active guidance.

The Rule defines “guidance documents” to include all “statement[s] 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.” Guidance documents are deemed “significant” if they are likely to result in any of the following:

  • an annual effect on the economy of $100 million or more;
  • the creation of a serious inconsistency or interfere with an action taken or planned by another agency;
  • a material alteration of the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof;
  • novel legal or policy issues arising out of legal mandates or the President’s priorities, or established processes of regulatory planning and review.

The Rule does not apply to agency organizational procedure or practice, to legal advice on legal opinions addressed to executive branch officials, or to opinions addressing issues specific to particular circumstances, facilities, or individuals. Significant guidance determinations will be made in consultation with the Office of Information and Regulatory Affairs. All guidance issued by EPA Regional Offices will require concurrence from the Presidentially-appointed EPA official who is responsible for administering the related national program.

Similar to the process used to adopt or change regulations, a notice of proposals to add or change significant guidance will be published in the Federal Register. Public comments will be accepted for a period of at least thirty days. EPA will be required to respond to major concerns and comments received and publish the final version of the guidance in the Federal Register.

Executive Order 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents,” was issued by President Trump on October 9, 2019. In implementing the Order, EPA invokes authority under the Federal Housekeeping Statute, which allows agencies to “prescribe regulations for . . . the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property.” 5 U.S.C. 301.

In addition to requirements for notice and comment prior to adopting or modifying guidance, the Order instituted a policy to clearly distinguish “active” and “inactive” guidance, primarily by restricting the guidance available through the official EPA guidance portal. Section 3(b) of the Order required agencies to “rescind those guidance documents that it determines should no longer be in effect.” Implementing this provision, the Office of Management and Budget issued instructions to agencies to establish searchable, indexed online databases for all active guidance documents, and to remove all inactive guidance. As of June 27, 2020 only guidance available through the official agency guidance portals qualifies as active guidance under the OMB policy.

EPA explains that new requirements will “help to ensure that guidance documents are not improperly treated as legally binding requirements by the EPA or by the regulated community.”  The new requirements will provide stakeholders and members of the public with an opportunity to provide input into guidance before it is finalized. The OMB online portal policy also clearly delineates which guidance documents are currently in effect. Interested members of the public may petition for the modification, withdrawal or reinstatement of guidance under the new Rule. The agency will evaluate petitions and respond within 90 days. If the agency grants a petition, the same notice and comment process that applies to agency-initiated changes is required.

For more information on these changes to guidance policy, or for assistance with tracking or participating in guidance development under the new Rule, please contact Andrea Rimer at or Louise Dyble at