June 16, 2020

Proposed Rule to Impact EPA’s Regulatory Guidance

In a May 2020 article, we discussed the creation of EPA’s new online guidance portal—a requirement of Executive Order (E.O.) 13891 (signed October 9, 2019). To meet the additional requirements of this order, EPA proposed an administrative rule that would establish procedures for the issuance, modification, and withdrawal of guidance documents and a corresponding public petition process. [85 FR 31104] The rule would be located in a new Subpart D to 40 CFR Part 2, titled “Guidance Procedures.” EPA is accepting comments on the proposed rule until June 22, 2020, and they may be submitted via Docket ID No. EPA-HQ-OA-2020-0128.

Definitions

“Guidance document” would be defined as “an Agency statement of general applicability, intended to have [a] 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….” The definition contains numerous exclusions such as internal guidance not intended to impact regulated parties, legal briefs, and grant solicitations. One additional and notable exclusion from the definition of “guidance document” would be statements of specific, rather than general, applicability. For example, advisory or legal opinions directed to particular parties about circumstance-specific questions would not be included in the proposed definition.

The definition of a “significant guidance document” comes from E.O. 13891 (and E.O. 12866) and is a guidance document that may reasonably be anticipated to:

Lead to an annual effect on the economy of $100 million or more, or negatively impact the economy or human health and the environment;
Create a serious inconsistency, or interfere, with an action taken or planned by another agency;
Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs; or
Raise novel legal or policy issues arising out of legal mandates, presidential priorities, or the principles of E.O. 12866.

Issuing, Modifying, and Withdrawing Guidance Documents

All guidance documents issued in the future would need to satisfy specific requirements. These include basic elements such as identifying the office issuing the guidance, providing a unique document identification number, and including a summary of the subject matter. Each new guidance document would be required to contain a disclaimer stating that the contents 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. Before issuing a new guidance document developed by an EPA regional office, the proposal would require that the region receive concurrence from the corresponding presidentially-appointed EPA official (e.g., the relevant Assistant Administrator) at EPA headquarters who is responsible for administering the national program to which the guidance document pertains.

EPA is proposing extensive additional requirements before a “significant guidance document” could be issued:

A Federal Register notice would announce the availability of a draft significant guidance document and a corresponding 30-day public review and comment opportunity. There could be exceptions to the comment process.
The guidance would be required to conform with E.O. 12866, 13563, 13609, 13771, 13777, and 13891.
A presidentially-appointed EPA official (e.g., the EPA Administrator) would have to approve the guidance before issuance.
A Federal Register notice would be published once the guidance is finalized. EPA would respond to major concerns and comments in the final guidance document itself or in a companion document.

New procedures would allow the public to petition for the modification or withdrawal of an active guidance document. While mailed paper submissions would be accepted, an electronic submittal via EPA’s guidance portal would be the preferred way the public can petition the agency for guidance modification or withdrawal. Petitions for consideration would need to meet various criteria including petition format, an explanation of the petitioner’s interest in the requested action, and rationale for modification or withdrawal. The agency would respond to petitions within 90 calendar days of receipt with a possible one-time 90-day extension.

When a guidance document is issued, modified, or withdrawn, the agency will inform the public via the EPA guidance portal.

Previously Issued Guidance

A potential concern arises regarding this fundamental question: Can the regulated community rely on previously issued guidance not found in EPA’s guidance portal? Page 31106 of the proposed rule preamble seems to provide a definitive answer:

“The E.O. [13891] requires that all active guidance documents issued by an agency be included on the agency’s guidance portal and that any guidance document excluded from the portal does not represent the final guidance of the agency and will have no effect.”

Language on the EPA guidance portal goes on to say: “The agency may not cite, use, or rely on any guidance that is not posted on this web area, except to establish historical facts.”

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Disclaimer

Considerable care has been exercised in preparing this document; however, McCoy and Associates, Inc. makes no representation, warranty, or guarantee in connection with the publication of this information. McCoy and Associates, Inc. expressly disclaims any liability or responsibility for loss or damage resulting from its use or for the violation of any federal, state, or municipal law or regulation with which this information may conflict. McCoy and Associates, Inc. does not undertake any duty to ensure the continued accuracy of this information.

This document addresses issues of a general nature related to the federal RCRA regulations. Persons evaluating specific circumstances dealing with the RCRA regulations should review state and local laws and regulations, which may be more stringent than federal requirements. In addition, the assistance of a qualified professional should be enlisted to address any site-specific circumstances.