The U.S. Environmental Protection Agency (EPA) recently finalized a rule that aims to improve transparency and establish consistent procedures for the issuance of agency guidance documents. The Final Rule was drafted in response to President Donald Trump’s Executive Order 1381, which directed federal agencies to improve agency guidance practices.

The regulation establishes general requirements and procedures for certain guidance documents issued by the EPA and incorporates additional requirements for guidance documents determined to be significant guidance. It also establishes procedures for the public to petition for the modification or withdrawal of active guidance documents or to petition for the reinstatement of a rescinded guidance document.

According to the EPA, the new regulation is intended to increase the transparency of the EPA’s guidance practices and improve the process used to manage EPA guidance documents. As stated in the Final Rule:

Implementing these procedures will lead to enhanced transparency and help to ensure that guidance documents are not improperly treated as legally binding requirements by the EPA or by the regulated community. Moreover, this regulation defines “guidance document” to provide greater clarity to the public regarding the scope of documents subject to these procedures. This regulation will improve the ability of members of the public to identify the guidance documents that the EPA uses and relies upon, resolving any concerns over the difficulty assessing the final, effective, active guidance of the Agency.

New Procedures for EPA Guidance

The procedures contained in the Final Rule apply to guidance documents, which are defined as  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.” Below are several other key provisions of the Final Rule:

  • General Requirements for Guidance: The Final Rule establishes several requirements for EPA guidance. Notably, guidance must include a disclaimer stating that the contents of the guidance document do not have the force and effect of law, and that the Agency does not bind the public in any way and intends only to provide clarity to the public regarding existing requirements under the law or Agency policies, except as authorized by law or as incorporated into a contract. When a guidance document is binding because binding guidance is authorized by law or because the guidance is incorporated into a contract, the statement will reflect that. Additionally, a guidance document issued by an EPA Regional Office must receive concurrence from the corresponding Presidentially-appointed EPA official (i.e., the relevant Assistant Administrator or an official who is serving in the acting capacity) at EPA headquarters who is responsible for administering the national program to which the guidance document pertains.
  • Requirements for Significant Guidance: EPA guidance documents are considered “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; or novel legal or policy issues arising out of legal mandates or the President’s priorities, or established processes of regulatory planning and review. Similar to the process for enacting or amending regulations, the EPA will make publicly available a draft significant guidance document, including a significant guidance document that is being reinstated, or draft modification of a significant active guidance document, for public comment before finalizing any significant guidance document. The EPA will publish the draft guidance in the Federal register and accept public comments for a period of at least 30 days. The EPA must respond to major concerns and comments received and publish the final guidance in the Federal Register. The Final Rules does provide exceptions to the public comment process, including when doing so is not feasible or appropriate because immediate issuance is required by a public health, safety, environmental, or other emergency and when the Agency for good cause finds that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest.
  • Procedures for the Public to Petition for Modification/Withdrawal: The public may submit a petition to the EPA for the modification or withdrawal of an active guidance document, or reinstatement of a rescinded guidance document. In order to be considered a valid petition under this section, the petition must address the guidance document in question itself and not merely underlying statutory or regulatory text. The EPA must make information about petitions received available to the public and respond within 90 calendar days.

What’s Next?

Going forward, the EPA will maintain an EPA Guidance Portal listing all effective, active EPA guidance documents that satisfy the definition in the Final Rule. As set forth in the Final Rule, any guidance document omitted from the portal “does not represent an active guidance document of the Agency and will have no effect except to establish historical facts.”

If you have questions, please contact us

If you have any questions or if you would like to discuss the matter further, please contact me, Dan McKillop, or the Scarinci Hollenbeck attorney with whom you work, at 201-896-4100.