On May 19, 2020, the U.S. Environmental Protection Agency (EPA) released its “first ever” proposed rule intended to improve the transparency of guidance. According to EPA, the new rule will significantly increase the transparency of its practices around guidance and will improve its process for managing guidance documents. When final, the rule will:

• Establish the first formal petition process for the public to request that EPA modify or withdraw a guidance document;

• Ensure that EPA’s guidance documents are developed with appropriate review and are accessible and transparent to the public; and

• Provide for public participation in the development of significant guidance documents.

EPA has posted a pre-publication version of the proposed rule. Publication in the Federal Register will begin a 30-day public comment period.

Background

On October 9, 2019, President Donald J. Trump (R) signed Executive Order (EO) 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.” 84 Fed. Reg. 55235. EO 13891 directs 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.”

Proposed Guidance Document Procedures

The proposed rule would establish EPA’s internal policies and procedures for the issuance of future guidance documents pursuant to the directives included in EO 13891, as well as codify the requirement that EPA maintain an Internet portal with all active and effective guidance of the agency. The procedures contained in the proposed rule would apply to guidance documents issued by EPA that are subject to the requirements of EO 13891 but not excluded under Section 4(b) of the EO. Section 4(b) directs the Administrator of the White House Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) to issue memoranda establishing exceptions from the EO for categories of guidance documents, as appropriate. Categorical exceptions may include documents that generally are only routine or ministerial, or that are otherwise of limited importance to the public. EPA proposes that the procedures established in the rule would not apply to guidance documents excepted from the requirements of EO 13891 under Section 4(b).

Definition of Guidance Document and Significant Guidance Document

Consistent with the definitions in EO 13891 and OMB’s implementing memorandum, EPA proposes the following definitions of the terms “guidance document” and “significant guidance document.”

• Guidance Document: For the purposes of the rule, “guidance document” would mean 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. The definition is subject to specified exclusions, including:

  • Rules promulgated pursuant to notice and comment under 5 U.S.C. Section 553, or similar statutory provisions;

  • Rules exempt from rulemaking requirements under 5 U.S.C. Section 553(a);

  • Rules of EPA organization, procedure, or practice;

  • Decisions of EPA adjudications under 5 U.S.C. Section 554, or similar statutory provisions;

  • Internal guidance directed to EPA or its components or other agencies that is not intended to have substantial future effect on the behavior of regulated parties;

  • EPA statements of specific, rather than general, applicability. The definition of “guidance document” would not apply to 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, including congressional correspondence or notices of violation;

  • EPA statements that do not set forth a policy on a statutory, regulatory, or technical issue or an interpretation of a statute or regulation. This would exclude from the definition of “guidance document” EPA statements that merely communicate news updates about the Agency, such as most speeches and press releases, as well as agency statements of general applicability concerning participation in EPA’s voluntary programs;

  • Internal executive branch legal advice or legal opinions addressed to executive branch officials or courts, including legal opinions by the Office of General Counsel;

  • Legal briefs and other court filings, because these are intended to persuade a court rather than affect the conduct of regulated parties;

  • Grant solicitations and awards; or

  • Contract solicitations and awards.

• Significant Guidance Document: For the purposes of the rule, “significant guidance document” would mean a guidance document determined to be significant pursuant to EOs 12866 and 13891.

Section 2(c) of EO 13891 defines “significant guidance document" to mean a guidance document that may reasonably be anticipated to: 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; create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles of EO 12866.

Inventory of Active Guidance Documents

EO 13891 Section 3(a) directs agencies to establish and maintain a website guidance portal that contains or links to guidance documents that are “active,” i.e., those guidance documents under this rule that EPA expects to cite, use, or rely upon. EPA made the EPA Guidance Portal publicly available on February 28, 2020. The EO 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.

In addition to the information associated with each guidance document, the EPA Guidance Portal includes a clearly visible note expressing that (a) guidance documents lack the force and effect of law, unless authorized by statute or incorporated into a contract; and (b) EPA may not cite, use, or rely on any guidance document, as defined in this rule, that is not posted on the EPA Guidance Portal, except to establish historical facts. The proposed rule states that the EPA Guidance Portal will also include a link to these EPA procedural regulations for guidance documents once issued as final regulations, as well as to any future proposed or final amendments.

General Requirements and Procedures for Issuance of All Guidance Documents

Consistent with EO 13891, EPA proposes to require certain standard elements for all guidance documents issued after the final rule is promulgated. Specifically, EPA proposes to require that each guidance document satisfy the following:

• Include the term “guidance”;

• Identify the office issuing the document;

• Provide the title of the guidance;

• Provide the unique document identification number;

• Include the date of issuance;

• When practicable, identify the general activities to which and the persons to whom the document applies;

• Include the citation to the statutory provision (including the U.S.C. citation) or regulation (in C.F.R. format) to which the guidance document applies or which it interprets;

• Note if the guidance document is a revision to a previously issued guidance document and, if so, identify the guidance document that it modifies or replaces;

• Include a short summary of the subject matter covered in the guidance document at the beginning of the document; and

• Include a disclaimer stating that the contents of the guidance document do not have the force and effect of law and that EPA does not intend to bind the public in any way and intends only to provide clarity to the public regarding existing requirements under the law or agency policies. If the guidance document is binding because it is authorized by law or because the guidance is incorporated into a contract, EPA will make that clear in the document.

Consistent with the requirements of EO 13891 and OMB’s implementing memorandum, each new guidance document will be posted in the EPA Guidance Portal upon issuance. When EPA issues a new guidance document, modifies an active guidance document, or withdraws an active guidance document, it proposes to inform the public via the EPA Guidance Portal or other EPA website. EPA requests comment on the most effective means to inform the public that a new guidance document has been issued, an active guidance document has been modified, or an active guidance document has been withdrawn.

The proposed rule states that given their legally nonbinding nature, guidance documents 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. For example, according to the proposed rule, a guidance document may explain how EPA believes a statute or regulation applies to certain regulated entities or activities. EPA notes that as a practical matter, it also may describe laws of nature, scientific principles, and technical requirements in mandatory terms so long as it is clear that the guidance document itself does not impose legally enforceable rights or obligations.

Before issuing a new guidance document covered by this rule that is developed by an EPA Regional Office, EPA proposes 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.

EPA states that it will seek significance determinations from OIRA for certain guidance documents, as appropriate, in the same manner as for rulemakings.

Requirements for Issuance of Significant Guidance Documents

Consistent with the requirements of EO 13891, EPA is proposing specific requirements for significant guidance documents. EPA states that it does not intend to supersede non-conflicting internal policy and procedures that it established for significant guidance documents in 2007 as part of its implementation of the OMB Bulletin for Agency Good Guidance Practices. Specifically, EPA is proposing the following additional requirements for significant guidance documents:

Notice and Public Comment Opportunities

The proposed rule would establish a public review and comment opportunity for all significant guidance documents, whether that document is new or a modification or withdrawal of an active guidance document. EPA proposes to require generally that it publish a notice in the Federal Register to announce the availability of a new draft significant guidance document and provide a 30-day public comment opportunity prior to issuing the final significant guidance document. EPA also proposes to require that it similarly publish a notice in the Federal Register announcing the proposed modification or withdrawal of an active significant guidance document and provide a 30-day public comment opportunity before modifying or withdrawing such a document. In addition to the published announcement of the availability of the draft significant guidance document, EPA would post the draft significant guidance document itself (including a link to any supporting documents) on its website concurrently and labeled appropriately. To ensure comments will be received and responded to by EPA, EPA states that public comments on draft significant guidance documents and draft modifications or withdrawals of significant active guidance documents should be submitted using the methods specified in the Federal Register notice announcing the availability of the draft significant guidance document or its withdrawal.

EPA would make all comments received on a draft significant guidance document, or draft modification or withdrawal of an active significant guidance document, available to the public either through the Federal eRulemaking Portal (i.e., https://www.regulations.gov/) or on the EPA website.

Final Significant Guidance Documents

EPA proposes to publish a notice in the Federal Register announcing when the issuance of a new or modified active significant guidance document or withdrawal of an active significant guidance document is completed.

The proposed regulations would also require EPA, when issuing a final new significant guidance document or a final modification or withdrawal of an active significant guidance document, to respond to major public comments and identify in the required Federal Register notice how the public may access the comments received and EPA’s response.

EPA requests comment on whether the issuance of a modification to an active significant guidance document or the withdrawal of an active significant guidance document should be announced via the Federal Register and subject to a 30-day public comment period, or if other means of public engagement, such as the EPA Guidance Portal or other agency website, could be used to announce such actions.

Procedural Exceptions

EPA proposes limited exceptions to the significant guidance document notice and comment process. EPA states that it would not seek or respond to public comment before it implements a significant guidance document (or any other category of guidance document) if exigent circumstances, as determined by the Administrator, (e.g., a public health, safety, environment, or other emergency) make it impracticable to delay issuance of the guidance document, or there is a statutory or judicial requirement that compels EPA to issue the document immediately. Furthermore, EPA would not seek or respond to public comment when it finds good cause that notice and public comment is impracticable, unnecessary, or contrary to public interest. EPA would present the good cause finding in the guidance document or notice of availability in the Federal Register.

Required Approval

The EPA Administrator or other Presidentially appointed EPA official, or an official who is serving in an acting capacity of either of the foregoing, would approve each significant guidance document before it is issued and posted on the EPA Guidance Portal.

Compliance with Other Applicable Requirements

Section 5 of EO 13891 specifies that significant guidance documents must demonstrate compliance with the requirements of EO 12866, “Regulatory Planning and Review”; EO 13563, “Improving Regulation and Regulatory Review”; and E.O. 13609, “Promoting International Regulatory Cooperation,” consistent with the requirements of Section 4 of EO 13891. EO 13891 directs that significant guidance documents must comply with the applicable requirements for regulations or rules, including significant regulatory actions, set forth in these executive orders.

Accordingly, EPA would comply with the requirements of EOs 12866, 13563, 13609, and 13891 when issuing significant guidance documents. For example, according to the proposed rule, EPA would assess the potential impacts of the significant guidance document if those effects may reasonably be anticipated to lead to an annual effect on the economy of $100 million. EPA states that the analysis (Regulatory Impact Analysis (RIA) or Economic Analysis (EA)) would focus on how that economically significant guidance document affects the incentives of regulated parties and would conform to OMB Circular A-4 on Regulatory Analysis and EPA Guidelines for Preparing Economic Analyses. 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).

Procedures for the Public to Petition for Modification or Withdrawal

Consistent with EO 13891, EPA proposes procedures to allow the public to petition for the modification or withdrawal of an active guidance document posted on the EPA Guidance Portal. The EPA Guidance Portal will provide clear and specific instructions regarding how to request the modification or withdrawal of an active guidance document. EPA proposes that the public may submit petitions using one of the two following methods described on the EPA Guidance Portal: (1) an electronic submission through 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 EPA’s designated mailing address listed on the EPA Guidance Portal.

Format and Content Elements for Public Petitions

EPA proposes the following formatting elements for petitions:

• The petitioner’s name and a means for EPA to contact the petitioner such as an e-mail address or mailing address, in addition to any other contact information (such as telephone number) that the petitioner chooses to include; and

• A heading, preceding its text that states, either “Petition to Modify a Guidance Document” or “Petition to Withdraw a Guidance Document.”

EPA proposes that a petition should include the following content elements:

• Identification of the specific 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 (i.e., modification or withdrawal);

• An explanation of the interest of the petitioner in the requested action;

• If practicable, specification of the text that the petitioner request be modified or withdrawn, and, where possible, suggested text for EPA to consider; and

• A rationale for the requested modification or withdrawal.

EPA states that although it may be able to consider incomplete petitions, petitions that omit the specified information may impede it from fully evaluating the merits of the requested action. EPA proposes that a petition that is not submitted using one of the two methods described above (as well as on the EPA Guidance Portal), but that includes the required formatting and content elements, will be treated as a properly filed petition, received as of the time it is discovered and identified. EPA notes that if a document does not include all of the format and content elements described above, it may be unable to identify the document as a petition for modification or withdrawal of a guidance document. These will instead be treated according to the existing correspondence or other appropriate procedures of EPA, and any suggestions contained in it will be considered at the discretion of the Administrator.

EPA requests comment on whether the procedural rule should specify any other information elements that should be addressed in a petition to modify or withdraw an active guidance document. EPA requests that any such comments explain how additional information elements would enable it to identify correctly and more completely evaluate a petition.

Required EPA Response to Public Petitions

EPA states that it would respond to petitions in a timely manner, but no later than 90 calendar days after receipt of the petition. If EPA requires more than 90 calendar days to consider a petition, it will inform the petitioner that more time is required, 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 states that “[i‌]t is important to note that the response and the set timeframes for responding to the petition are not intended to capture the implementation of the response.” For example, if EPA agrees with a petitioner seeking a modification to a guidance document, it will pursue the modification in accordance with applicable procedures. In such cases, EPA intends for the response to the petition to include its approach for completing the modification of that guidance document.

Under the proposed rule, EPA may respond to duplicative petitions and petitions submitted as part of a mass petitioning effort in a single response to ensure an efficient and consistent response to the petitions. EPA will not consider petitions that request a change to the underlying statute or promulgated rules, rather than specific text in the guidance document, as valid petitions under this process because they are not petitions to modify or withdraw a guidance document.

EPA requests comment on whether it should create unified public petition procedures, similar to those proposed in this rule for guidance documents, for EPA rulemakings in addition to the public petition right established in Section 553(e) of the Administrative Procedure Act.

Commentary

The subject of “transparency” in rulemaking is controversial, and this “first-ever” rule on “transparency in guidance” will similarly invite diverse views. The entire construct is fraught with uncertainty, especially in the arcane areas on which we focus -- the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). We question how EPA will identify all active and effective guidance, for example. Guidance is seldom withdrawn or officially replaced except in the context of enforcement guidance. The exclusion of otherwise current guidance that may have been long-forgotten but nonetheless on which stakeholders rely could itself invite unintended legal and regulatory consequences.

Similarly, commenters are expected to disagree on what falls within the definition of “guidance document” and what is excluded. For example, internal guidance documents in the FIFRA and TSCA areas often function as de facto guidance and exert considerable influence on EPA’s decision-making process. Who will decide whether such documents are “not intended to have substantial future effect” and thus should be excluded from the rule? What if notwithstanding intent, the guidance in fact exhibits substantial future effect? Yet, this class of documents is considered exempt.

The list of issues is long and complicated. Perhaps the proposal is intended to jump-start a longer and more informed discussion, one that cannot reasonably be expected to occur within 30 days.