November 16, 2020

EPA Rule Creates New Procedures for Managing Guidance

On October 19, 2020, EPA finalized a rule establishing procedures for managing guidance via the agency’s guidance portal. [85 FR 66230] Proposed in May 2020 [85 FR 31104], the rule creates a new 40 CFR Part 2, Subpart D titled “Guidance Procedures.” This new subpart contains definitions for various types of guidance and delineates the content and format of such documents. More importantly, the regulations establish requirements for issuing and approving guidance and procedures for the public to petition for its modification, withdrawal, or reinstatement. The rule takes effect on November 18, 2020.

Definitions

Definitions are found in new §2.503. “Guidance document” is defined as “an agency 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….” The definition contains numerous exclusions such as internal guidance not intended to impact regulated parties, legal briefs, and grant solicitations. A notable exclusion from this definition is for statements of specific, rather than general, applicability. For example, advisory or legal opinions directed to particular parties about circumstance-specific questions are not included in the definition.

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

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

Not proposed initially, but added to the final rule, are definitions for “active guidance document” and “rescinded guidance document.” An “active guidance document” is “a guidance document or significant guidance document in effect that EPA expects to cite, use, or rely upon.” All active guidance documents will be contained in EPA’s guidance portal. [§2.504]

A “rescinded guidance document” is “a document that would otherwise meet the definition of a guidance document or significant guidance document, but that the EPA may not cite, use, or rely upon except to establish historical facts.” Rescinded guidance documents are not included in EPA’s guidance portal.

Issuing, Modifying, and Withdrawing Guidance Documents

Starting November 18, 2020, all guidance issued by EPA will need to satisfy specific requirements. These include identifying the office issuing the guidance, providing a unique identification number, identifying affected parties, providing applicable statutory and/or regulatory citations, and including a summary of the subject matter. Each new guidance document requires a disclaimer stating the contents do not have the force and effect of law and do not bind the public in any way, but only provide clarity regarding existing requirements under the law or agency policies.

Before issuing a new guidance document developed by an EPA regional office, the region must 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. Guidance documents will also avoid using mandatory language such as the words “shall,” “must,” or “required.” [§2.505]

In addition to meeting the criteria mentioned above, a “significant guidance document” must:

  1. Be preceded by a Federal Register notice announcing the availability of the draft guidance document and a corresponding 30-day public review and comment opportunity. This review and comment process may be modified or eliminated at the sole discretion of the EPA Administrator.
  2. Conform to E.O. 12866, 13563, 13609, 13771, 13777, and 13891.
  3. Be approved by a presidentially-appointed EPA official (e.g., the EPA Administrator) before issuance.
  4. Be finalized concurrently with another Federal Register notice. EPA will respond to major concerns and comments in the final guidance document itself or a companion document. [§2.506]

The public may petition for the modification or withdrawal of an active guidance document or reinstatement of a rescinded guidance document. Both mailed paper submissions and electronic submittals via EPA’s guidance portal are accepted. Petitions for consideration must meet various criteria including petition format, an explanation of the petitioner’s interest in the requested action, and rationale for modification, withdrawal, or reinstatement. The agency will respond to petitions within 90 calendar days of receipt with a possible one-time 90-day extension. [§2.507]

 


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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.