/>iOn October 19, 2020, the U.S. Environmental Protection Agency (EPA) published a final rule establishing the procedures and requirements for how EPA will manage the issuance of guidance documents consistent with Executive Order (EO) 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.” 85 Fed. Reg. 66230. The final regulation provides a definition of guidance document for the purposes of this rule, establishes general requirements and procedures for certain guidance documents issued by EPA, and incorporates additional requirements for guidance documents determined to be significant guidance. EPA notes that the regulation, consistent with the EO, also provides procedures for the public to petition for the modification or withdrawal of active guidance documents as defined by the rule or to petition for the reinstatement of a rescinded guidance document. EPA states that the regulation is intended to increase the transparency of its guidance practices and improve the process used to manage its guidance documents. The final rule will be effective November 18, 2020.
Background
On October 9, 2019, President Donald J. Trump signed EO 13891, directing federal agencies to issue regulations that “set forth processes and procedures for issuing guidance documents.” EPA notes on its web page for the proposed rulemaking that a central principle of the EO is that “guidance documents should clarify existing obligations only; they should not be a vehicle for implementing new, binding requirements on the public.” EPA states that “EO 13891 recognizes that these documents, when designated as significant guidance documents, could benefit from public input prior to issuance.”
Guidance Document Procedures
The final rule establishes EPA’s internal policies and procedures for the issuance of future guidance documents pursuant to the directives included in EO 13891 and codifies the requirement that EPA maintain an Internet portal with a list of all effective, active EPA guidance documents meeting the definition in the regulation. The procedures apply to guidance documents, as defined by this regulation, issued by EPA and not excluded under Section 4(b) of EO 13891. Section 4(b) directs the Administrator of the Office of Information and Regulatory Affairs (OIRA) to issue memoranda establishing exceptions from the EO for categories of guidance documents, as appropriate. EPA states that categorical exceptions may include documents that generally are only routine or ministerial, or that are otherwise of limited importance to the public. The procedures established in the final rule do not apply to guidance documents excepted from the requirements of EO 13891 under Section 4(b), as interpreted by OIRA M-20-02, the Memorandum for Regulatory Policy Officers at Executive Departments and Agencies and Managing and Executive Directors of Certain Agencies and Commissions on “Guidance Implementing Executive Order 13891, Titled ‘Promoting the Rule of Law Through Improved Agency Guidance Documents,’” or otherwise excepted by the Administrator of OIRA. Information on EPA’s proposed rule is available in our May 21, 2020, memorandum, “EPA Releases Proposed Rule Intended to Improve the Transparency of Guidance.”
Definition of Guidance Document and Significant Guidance Document
EPA states that it adopted the definition of guidance document set forth in EO 13891 “with only minor modifications and believes the listed exclusions are helpful in distinguishing the types of documents that do not meet the definition.” “Guidance document” means an EPA 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, subject to certain exclusions. “Significant guidance document” means a guidance document that is determined to be “significant” pursuant to EO 12866 and EO 13891.
To provide further clarity in the implementation of the rule, EPA states that it has also included definitions for “active guidance document” and “rescinded guidance document.” EPA defines “active guidance document” as a guidance document or significant guidance document in effect that EPA expects to cite, use, or rely upon. Conversely, EPA defines a “rescinded guidance document” as a document that would otherwise meet the definition of a guidance document or significant guidance document, but that EPA may not cite, use, or rely upon except to establish historical facts.
EPA has determined that the definition of “guidance document” includes certain scientific and/or technical documents. For example, EPA has determined that drinking water health advisories and Clean Water Act (CWA) Section 304(a) national recommended Water Quality Criteria issued by EPA’s Office of Water 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. EPA notes that it releases a great deal of technical information (including scientific information) that would not be subject to the regulation, however, “because it is not a statement intended to affect the future behavior of regulated parties that sets forth a policy on a statutory, regulatory, or technical issue, or an interpretation of a statute or regulation.”
Inventory of Active Guidance Documents
EPA proposed that all active guidance documents that it issued be included on the EPA Guidance Portal. Starting on the effective date of the final rule, November 18, 2020, all active guidance documents must appear on the EPA Guidance Portal. According to EPA, any guidance document excluded from the EPA Guidance Portal “does not represent an active guidance document of the Agency and will have no effect except to establish historical facts.”
EPA states that it will work to improve continually the transparency of the EPA Guidance Portal, including exploring ways to inform the public of the status of documents not included on the Portal. EPA recommends that questions regarding specific guidance documents omitted from the EPA Guidance Portal be directed to the relevant EPA program or Regional Office that issued the document. EPA is adopting new procedures for the public to petition for reissuance of a rescinded guidance document that the petitioner believes should be included on the EPA Guidance Portal.
According to the notice, EPA agrees with commenters that the usability and functionality of the EPA Guidance Portal could be improved. In consideration of these comments, EPA states that it will continue to evaluate and work to improve the functionality of the Portal, such as improving search capabilities and notification mechanisms.
The final rule requires that all active guidance documents be published on the EPA Guidance Portal and that any guidance document excluded from the list of active guidance documents published on the Portal “does not represent an active guidance document (as defined in this regulation) of the Agency and will have no effect, as proposed.” When a new guidance document is issued, an active guidance document is modified, or an active guidance document is withdrawn, EPA states that it will inform the public via the EPA Guidance Portal.
As noted in the proposed rule, the list of active guidance documents on the EPA Guidance Portal is intended to contain only documents that meet the definition of “guidance document” and “significant guidance documents.” According to EPA, documents that are excluded from that definition will not typically be included in the list of active guidance documents on the EPA Guidance Portal, although they may still be in effect. For example, the definition of guidance documents excludes, among others, internal guidance directed to EPA or its components or other agencies, statements of specific rather than general applicability, and internal executive branch legal advice or legal opinions addressed to executive branch officials, provided these actions are not intended to have substantial future effect on the behavior of regulated parties. EPA states that because excluded documents are not “guidance documents” under this regulation, their omission from the EPA Guidance Portal does not imply that they are “rescinded guidance documents.”
General Requirements and Procedures for Issuance of All Guidance Documents
EPA proposed to require certain standard elements for all guidance documents issued after the effective date of this final rule, consistent with EO 13891. Specifically, EPA proposed to require that each guidance document would include: the term “guidance”; the issuing office; the title; a unique identification number; the date issued; the general activities to which and persons to whom it applies (when practicable); a citation to the statutory provision or regulation; whether it was a revision to a previous document; a summary; and a disclaimer as to the non-binding nature of guidance documents. EPA states that it believes the current set of elements strikes the appropriate balance between consistency and flexibility.
According to EPA, most commenters supported the proposed requirement that guidance documents refrain from using mandatory language. Consistent with these comments, the final rule requires that guidance documents, given their legally nonbinding nature, will avoid including mandatory language such as “shall,” “must,” “required,” or “requirement,” unless these words are used to describe a statutory or regulatory requirement, or the language is addressed to EPA staff and will not foreclose consideration by EPA of positions advanced by affected private parties.
EPA states that most comments were supportive regarding the requirement that the 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 before issuing a new guidance document developed by an EPA Regional Office. Therefore, the final rule includes this concurrence requirement as proposed.
For significant guidance documents, EPA proposed to require public notice in the Federal Register and a minimum 30-day comment period. Several commenters recommended that EPA expand the notice and comment requirement to cover most or all guidance covered by this rulemaking, however, not just those defined as “significant.” Some commenters stated that broader application of the notice and comment requirements could delay issuance of non-significant guidance. EPA states that it disagrees that it is necessary to expand the notice and comment requirements for significant guidance documents to all guidance documents.
Requirements for Issuance of Significant Guidance Documents
EPA proposed additional requirements for significant guidance documents beyond the requirements for all guidance documents. These proposed requirements for significant guidance documents include announcements in the Federal Register, a minimum 30-day comment period, response to comments, approval by Presidential appointees, review by OIRA under EO 12866 before issuance, and compliance with other EOs. EPA states that it agrees with commenters that the notice and comment requirements for significant guidance documents would increase transparency and public participation. As noted in the proposal preamble, EPA reiterates that the 30-day public comment opportunity for significant guidance documents is a minimum, and EPA retains discretion to use longer comment periods and will do so when warranted by circumstances surrounding the issuance of a specific guidance document. As stated in the proposal preamble, EPA does not intend to supersede non-conflicting internal policy and procedures that EPA established for significant guidance documents in 2007 as part of its implementation of the Office of Management and Budget’s (OMB) Bulletin for Agency Good Guidance Practices (2007). According to the notice, EPA will continue to follow recognized best practices, such as those identified in the 2007 Bulletin, in responding to public comments received on guidance documents. After consideration of the public comments, the final rule includes additional specific requirements for significant guidance documents and the exceptions to the comment requirement, as proposed, with a minor modification to clarify that approval of significant guidance documents will occur on a non-delegable basis, consistent with EO 13891.
Procedures for the Public to Petition for Modification or Withdrawal
Consistent with EO 13891, EPA proposed procedures to allow the public to petition for the modification or withdrawal of an active guidance document posted on the EPA Guidance Portal. EPA proposed formatting and content elements for petitions to enable a full evaluation of the merits of the requested action, including the petitioner’s name and contact information, title and the EPA unique identifier of the guidance document that the petitioner is requesting be modified or withdrawn, the nature of the relief sought by the petitioner, and the rationale for their request, among other elements.
Additionally, the proposed rule included requirements to ensure timely responses to petitions. EPA would respond to petitions no later than 90 calendar days after receipt of the petition. If EPA requires more than 90 calendar days to consider a petition, it would inform the petitioner that more time is required and indicate the reason why and provide an estimated decision date. EPA would only extend the response date one time for a period not to exceed 90 calendar days before providing a response. EPA noted in the proposed rule that the response and the set timeframes for responding to the petition are not intended to capture the implementation of the response.
After consideration of public comments, EPA states that it is adopting these requirements with minor modifications. The EPA Guidance Portal will provide clear and specific instructions to the public regarding how to request the modification or withdrawal of an active guidance document. The public may submit petitions using one of the two following methods described on the EPA Guidance Portal: (1) an electronic submission through the EPA’s designated submission system identified on the EPA Guidance Portal (i.e., using a link labeled “Submit a petition for Agency modification or withdrawal of guidance documents”); or (2) a paper submission to the EPA’s designated mailing address listed on the EPA Guidance Portal.
The final rule requires that EPA make available to the public information about petitions received, including the title of the putative guidance document to which the petition pertains. EPA asks stakeholders to note that the information about petitions received may, from time to time, include references to invalid petitions (such as petitions that do not request that EPA modify or rescind an active guidance document or reinstate a rescinded guidance document), and that references to such invalid petitions is not an acknowledgement by EPA that the documents referenced by those petitions are guidance documents as defined by these procedures. According to the notice, EPA will evaluate the feasibility of making its responses to petitions publicly available once more information exists about the volume and complexity of petitions.
EPA states that it agrees with commenters that it is appropriate for the public to have a formal mechanism to request that a rescinded guidance document be included on the EPA Guidance Portal and is providing procedures for the public to petition for reinstatement of a rescinded guidance document. According to the notice, EPA is limiting these procedures to rescinded guidance documents due to concerns about the potential administrative burden associated with processing petitions of unknown scope and number to reclassify other categories of documents as guidance documents. In response to comments, EPA is clarifying that petition procedures for modification or withdrawal apply to all active guidance documents on the EPA Guidance Portal. For petitions for reinstatement, the procedures apply to guidance documents not currently on the EPA Guidance Portal.
Deviation from Procedures
EPA proposed to allow it to deviate from the procedures set forth in the regulation when necessary at the written direction of the Administrator and in the Administrator’s sole and unreviewable discretion. According to EPA, several commenters claimed that allowing deviation undermines the purpose of the proposed rulemaking, would decrease transparency and certainty, would be contrary to the fundamental principle of administrative law to explain the Agency’s decisions, and would lower the likelihood of consistency through this and future administrations. EPA states that it agrees with these commenters and is not adopting this provision.
Commentary
The final rule will likely have the intended effect of increasing transparency in the regulatory guidance development process and improve the process used to manage EPA guidance documents. It will also, however, likely hinder the development of such guidance in the future, especially where it is considered significant. Resources traditionally used to develop and implement regulations, including often-needed guidance documents, will now need to meet the new mandatory procedures for guidance, possibly leaving the regulated community in limbo without having access to the timely guidance they would otherwise have received. It is not a reach to speculate that EPA might in certain circumstances forgo entirely providing guidance because of the increased burden, denying the regulated community valuable insights into EPA’s views until an interpretation is challenged in an audit or other enforcement situation.
We note that the final rule at 40 C.F.R. Section 2.502(c) states in part that the rule “is for the use of EPA personnel only and is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its agencies or other entities, its officers or employees, or any other person.” Given the rule’s procedures that allow the public to petition EPA for modification or withdrawal of active guidance documents on the EPA Guidance Portal, and for the inclusion of rescinded guidance documents on the Portal, it is difficult to see how the rule is not intended for use by the public, in addition to EPA personnel. Under the procedures in the rule, the public can alter, by petitioning EPA, the guidance EPA considers active, and the procedure includes specific deadlines for EPA to respond to petitions. If the deadlines in the rule create no right or benefit to the public and are not enforceable, they could be viewed by EPA as “soft” obligations, especially where there are competing priorities, and likely will often not be met. This could leave the public without guidance it might otherwise have available to it in the absence of the procedures.
Notwithstanding the new procedures and the materials included on the Portal, we believe there are existing guidance documents not listed as active on the EPA Guidance Portal, and thus that are considered “rescinded guidance” that can be relied on for EPA’s historical views on issues. Where these historical views may not be inconsistent with subsequent active guidance, it would be logical to assume the historical documents include guidance that may be applicable currently. EPA has not included all guidance documents on its Portal that represent current policy positions; EPA seems to recognize this in the final rule. Under the new procedures and to ensure clarity, it would be prudent for entities to petition EPA to include guidance documents believed to be relevant and representative of current EPA positions, but by their absence, these guidance documents may wrongly be considered “rescinded.”
Keeping the Guidance Portal current will require a resource commitment on EPA’s part. Even at this early stage, we were able to identify instances of guidance documents that were not consistently labeled with tags, correct dates, and other metadata. As time passes, the Guidance Portal may drift into irrelevancy absent diligent effort across EPA to keep the information in the Portal relevant and up to date.
