The Nickel Report

Agency guidance will be subject to certain standards and procedures under a proposed rule published by EPA in the Federal Register on May 22, 2020.  According to EPA, the proposed rule is “intended to increase the transparency of EPA’s guidance practices and improve the process used to manage EPA guidance documents.”  EPA will accept written comments on the proposed rule until June 22, 2020.

Consistent with Executive Order 13891, Promoting the Rule of Law Through Improved Agency Guidance Documents (October 9, 2019), the proposed rule

• Provides that EPA will use an online portal to clearly identify guidance documents,
• Defines “guidance document” and “significant guidance document,”
• Establishes standard elements for such guidance documents and significant guidance documents,
• Establishes procedures for public comment on proposed significant guidance documents, and
• Establishes procedures for the public to request that an active guidance document be modified or withdrawn.

Online Portal

E.O. 13891 directs agencies to establish and maintain a website guidance portal that contains or links to “active” guidance documents – those guidance documents that EPA expects to cite, use, or rely upon.  EPA’s Guidance Portal already is available at https://www.EPA.gov/guidance, although EPA has not completed its inventory of active guidance documents (it anticipates updating the portal before June 27, 2020).  Under the proposed rule, only guidance documents available at the portal would be deemed official agency guidance.

Definitions of Guidance Document and Significant Guidance Document

EPA proposes to define “Guidance Document” 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.”  EPA proposes 11 exclusions from the definition, including advisory or legal opinions directed to particular parties about circumstance-specific questions and correspondence with individual persons or entities about particular matters.

EPA proposes to define “Significant Guidance Document” as a guidance document determined to be significant pursuant to E.O. 13891 and E.O. 12866.  A “significant guidance document” pursuant to E.O. 13891 includes guidance that may reasonably be anticipated to (i) “lead to an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities” or (ii) raise “novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles of E.O. 12866.”  (E.O. 12866, Regulatory Planning and Review, signed by President Clinton in 1993, defines significant regulatory actions using the same language.)

Standard Elements/Requirements

EPA proposes that all guidance documents include certain terms, including a disclaimer that the guidance does not have the force and effect of law and that it is not intended to bind the public in any way and only is intended to clarify existing requirements under the law or EPA policies.  EPA Regional Offices would be required to obtain concurrence from a Presidentially-appointed EPA official at EPA headquarters before issuing a new guidance document under the proposal.

The EPA Administrator or other Presidentially-appointed EPA official (in an official or acting capacity) would be required to approve each significant guidance document before it is issued and posted on the EPA Guidance Portal.  And, consistent with E.O. 13891, under the proposed rule, EPA would comply with the requirements of Executive Orders 12866, 13563 (Improving Regulation and Regulatory Review), 13609 (Promoting International Regulatory Cooperation), and 13891 when issuing significant guidance documents.  (According to the proposed rule, EPA has not historically issued economically significant guidance documents – i.e., those that lead to an annual effect on the economy of $100 million or more.)

Public Notice and Comment

The proposed rule would establish a public review and comment opportunity for any significant guidance document, whether that document is new or modification or withdrawal of an active guidance document.  All comments received would be made publically available.  EPA would be required to respond to “major” concerns and comments in the final significant guidance document or in a companion document.

EPA would not be required to seek or respond to comments before implementing a significant guidance document if, at the sole discretion of the EPA Administrator, doing so would not be feasible or appropriate because immediate issuance is required due to an emergency or court order.  A similar exception would be provided when EPA determines for good cause that notice and comment are impracticable, unnecessary, or contrary to the public interest.

Modifying or Withdrawing Active Guidance Documents

Consistent with E.O. 13891, the proposed rule would allow members of the public to petition EPA for the modification or withdrawal of an active guidance document.  EPA would be obligated to respond in a timely manner, not to exceed 90 days (or 180 days if EPA informs the petitioner that EPA needs more time).

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The proposed rule is available at regulations.gov and via EPA’s website.