- What Happened: EPA finalized new procedures for issuing, identifying, and maintaining Agency guidance documents.
- Who’s Impacted: The regulated community and any other stakeholders who rely on EPA guidance to inform their own compliance approaches.
- What Companies Should Consider Doing in Response:
- Review the new procedures and EPA Guidance Portal.
- Identify whether key guidance on which your company relies is located in the Portal.
- If such guidance has been rescinded by the Portal, consider petitioning for withdrawal of any existing contrary guidance, modification to the governing guidance, or reinstatement of the earlier guidance.
On September 14, 2020, the U.S. Environmental Protection Agency (EPA) finalized a new rule that significantly modifies the Agency’s procedures for issuing and maintaining guidance documents. The new requirements, which have not yet been published in the Federal Register, are intended to implement the directives in Executive Order (E.O.) 13891, which directs Federal agencies to finalize regulations that “set forth processes and procedures for issuing guidance documents.”
First proposed by EPA on May 22, 2020, EPA’s final guidance procedures regulation will appear in a new subpart D under 40 C.F.R. Part 2. Among other things, the regulation requires EPA to use an online portal to identify all active EPA guidance documents for the public. As outlined in our prior alert, the EPA Guidance Portal was initially made available on February 28, 2020, and was fully populated to include all active guidance documents on July 31, 2020. The new rule requires all active guidance to appear in the EPA Guidance Portal and establishes that any guidance document excluded from the EPA Guidance Portal is rescinded and EPA cannot rely upon it (except to establish historical facts).
What Is A “Guidance Document”?
EPA’s new rule will apply to any “guidance document,” which is defined to mean “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.” Expressly exempt from this definition are Agency statements of specific, rather than general, applicability, such as:
- advisory or legal opinions directed to particular parties about circumstance-specific questions;
- notices regarding particular locations or facilities; and
- correspondence with individual persons or entities about particular matters, “unless a document is directed to a particular party but designed to guide the conduct of the broader regulated public.”
In response to comments on its May 22 proposal, EPA explained that it has determined that the definition of “guidance document” includes certain scientific and technical documents. For example, EPA notes that drinking water health advisories and Clean Water Act (CWA) 304(a) national recommended Water Quality Criteria are guidance documents because they are statements of general applicability, set forth a policy on a technical issue, are intended to have future effect on the behavior of regulated parties, and are not subject to one of the listed exclusions. At the same time, EPA declined to categorically determine that all scientific and technical documents are “guidance documents” similarly subject to the new rules.
How Will the EPA Guidance Portal Work?
All active EPA guidance documents can now be found in the EPA Guidance Portal, and any historic guidance documents that were not included in the EPA Guidance Portal by July 31, 2020 are rescinded. Among the changes made to its original proposal, EPA has now added new definitions for “active guidance document” (that is, “a guidance document or significant guidance document in effect that EPA expects to cite, use, or rely upon”) and “rescinded guidance document” (defined to mean “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”). In the final rule’s preamble, EPA underscored that its regulation is not intended to affect any past EPA actions that relied upon EPA guidance documents that are now rescinded. EPA also noted that it cannot limit how non-Agency parties use rescinded guidance, as long as they do not represent rescinded guidance documents as current Agency policy.
Whenever a new guidance document is issued, an active guidance document is modified, or an active guidance document is withdrawn, EPA will inform the public via the EPA Guidance Portal. The EPA Guidance Portal will also provide instructions to the public regarding how to request the modification or withdrawal of an active guidance document. Specifically, the public may submit petitions using one of the two following methods:
(1) an electronic submission through EPA’s designated submission system identified on the EPA Guidance Portal, or
(2) a paper submission to EPA’s designated mailing address.
EPA intends to make available to the public information about petitions received, including the title of the putative guidance document to which the petition pertains.
EPA also agreed with commenters that it is appropriate for the public to have a formal mechanism to request changes to guidance in the Portal. The final rules provide procedures for withdrawal, modification or reinstatement of a guidance document and provides procedures for the public to petition the EPA. The petition must include:
(1) Identification of the specific title the guidance document that the petitioner is requesting be modified, withdrawn, or reinstated;
(2) For petitions to modify or withdraw a guidance document only, the EPA unique identifier of the guidance document;
(3) The nature of the relief sought (i.e., modification, withdrawal, or reinstatement);
(4) An explanation of the interest of the petitioner in the requested action (i.e., modification, withdrawal, or reinstatement);
(5) For petitions to modify or withdraw a guidance document only, and only if practicable, specification of the text that the petitioner request be modified or withdrawn, and, where possible, suggested text for the Agency to consider; and
(6) A rationale for the requested modification, withdrawal, or reinstatement.
The final rules set a time period of 90 days for EPA to respond to the petition, with a one-time extension of time not to exceed 90 days.