EPA Guidance; Administrative Procedures for Issuance and Public Petitions, 31104-31111 [2020-11079]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 85, Number 100 (Friday, May 22, 2020)]
[Proposed Rules]
[Pages 31104-31111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11079]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 2

[EPA-HQ-OA-2020-0128, FRL-010007-83-OP]
RIN 2010-AA13


EPA Guidance; Administrative Procedures for Issuance and Public 
Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: These proposed regulations would, if finalized, establish the 
procedures and requirements for how the U.S. Environmental Protection 
Agency (EPA) will manage the issuance of guidance documents subject to 
the requirements of the Executive order entitled ``Promoting the Rule 
of Law Through Improved Agency Guidance Documents.'' These regulations 
establish general requirements and procedures for certain guidance 
documents issued by the EPA and incorporates additional requirements 
for guidance documents determined to be significant guidance under the 
Executive order. These regulations also provide procedures for the 
public to petition for the modification or withdrawal of active 
guidance documents under the Executive order. These regulations are 
intended to increase the transparency of EPA's guidance practices and 
improve the process used to manage EPA guidance documents.

DATES: Comments must be received on or before June 22, 2020.

ADDRESSES: Send comments, identified by Docket ID No. EPA-HQ-OA-2020-
0128, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/ 
(our preferred method). Follow the online instructions for submitting 
comments.
     Email: [email protected]. Include Docket ID No. EPA-HQ-
OA-2020-0128 in the subject line of the message.
    Instructions: All submissions received must include the Docket ID 
No. for this rulemaking. Comments received may be posted without change 
to https://www.regulations.gov/, including any personal information 
provided. For detailed instructions on sending comments and additional 
information on the rulemaking process, see the ``Public Participation'' 
heading of the SUPPLEMENTARY INFORMATION section of this document. Out 
of an abundance of caution for members of the public and our staff, the 
EPA Docket Center and Reading Room was closed to public visitors on 
March 31, 2020, to reduce the risk of transmitting COVID-19. Our Docket 
Center staff will continue to provide remote customer service via 
email, phone, and webform. We encourage the public to submit comments 
via https://www.regulations.gov or email, as there is a temporary 
suspension of mail delivery to EPA, and no hand deliveries are 
currently accepted. For further information on EPA Docket Center 
services and the current status, please visit us online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Sharon Cooperstein, Policy and 
Regulatory Analysis Division, Office of Regulatory Policy and 
Management (Mail Code 1803A), Environmental Protection Agency, 1200 
Pennsylvania Avenue Northwest, Washington, DC 20460; telephone number: 
202-564-7051; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Written Comments

    Submit your comments, identified by Docket ID No. EPA-HQ-OA-2020-
0128, at https://www.regulations.gov (our preferred method), or the 
other methods identified in the ADDRESSES section. Once submitted, 
comments cannot be edited or removed from the docket. The EPA may 
publish any comment received to its public docket. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. Multimedia submissions (audio, video, etc.) must be 
accompanied by a written comment. The written comment is considered the 
official comment and should include

[[Page 31105]]

discussion of all points you wish to make. The EPA will generally not 
consider comments or comment contents located outside of the primary 
submission (i.e. on the web, cloud, or other file sharing system). For 
additional submission methods, the full EPA public comment policy, 
information about CBI or multimedia submissions, and general guidance 
on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

B. Does this action apply to me?

    This is a rule of Agency procedure and practice. The provisions 
only apply to the EPA and do not regulate any external entities.

C. What action is the Agency taking?

    This action solicits comment from the public on a proposed 
regulation establishing procedures that the EPA intends to use to issue 
guidance documents that are subject to the requirements of Executive 
Order (E.O.) 13891, ``Promoting the Rule of Law Through Improved Agency 
Guidance Documents'' (84 FR 55237, October 15, 2019), which directs 
Federal agencies to develop regulations to set forth processes and 
procedures for issuing guidance documents. The Administrator has sole 
and unreviewable discretion to deviate from this procedure.

D. What is the Agency's authority for taking this action?

    The EPA is authorized to promulgate this rule under its 
housekeeping authority. The Federal Housekeeping Statute provides that 
``[t]he head of an Executive department or military department may 
prescribe regulations for the government of his department, the conduct 
of its employees, the distribution and performance of its business, and 
the custody, use, and preservation of its records, papers, and 
property.'' 5 U.S.C. 301. The EPA gained housekeeping authority through 
the Reorganization Plan No. 3 of 1970, 84 Stat. 2086 (July 9, 1970), 
which ``convey[s] to the [EPA] Administrator all of the housekeeping 
authority available to other department heads under section 301'' and 
demonstrates that ``Congress has vested the Administrator with the 
authority to run EPA, to exercise its functions, and to issue 
regulations incidental to the performance of those functions.'' \1\
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    \1\ Authority of EPA to Hold Employees Liable for Negligent 
Loss, Damage, or Destruction of Government Personal Property, 32 
O.L.C. 79, 2008 WL 4422366 at * 4 (May 28, 2008) (``OLC Opinion'')
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    The Agency considers this action a rule of agency organization, 
procedure, or practice that lacks the force and effect of law. The EPA 
determined, as a matter of good government, to seek comment from the 
public. The Administrative Procedure Act (APA), 5 U.S.C. 553(b)(3)(A), 
provides that an agency may issue interpretive rules, general 
statements of policy, or rules of agency organization, procedure, or 
practice without providing notice and an opportunity for public 
comment.

II. Background

    The EPA uses an open and fair regulatory process, including notice 
and an opportunity for comment, when imposing new obligations on the 
public, consistent with applicable law and following appropriate 
procedures. The EPA considers and responds to applicable comments 
before publishing final regulations in the Federal Register. Legally 
binding requirements are imposed on the public only through statutes 
and implementing regulations and on parties on a case-by-case basis 
through adjudications. Exceptions may exist when legally binding 
requirements are authorized by law through other means or when they are 
incorporated into a contract.
    The EPA may issue non-binding guidance using a variety of methods 
to clarify existing obligations and provide information to help 
regulated entities comply with requirements. Guidance documents come in 
a variety of formats, including interpretive memoranda, policy 
statements, manuals, bulletins, advisories, and more. Any document that 
satisfies the definition of ``guidance document'' above would qualify, 
regardless of name or format.
    Such guidance is not subject to APA notice-and-comment 
requirements. As such, EPA guidance documents are legally non-binding. 
The EPA does, however, often work with stakeholders to develop guidance 
documents, provide opportunities for public review and comment on the 
draft guidance document, and announces the availability of final 
guidance documents. Nevertheless, members of the public have noted that 
it is often difficult to identify all guidance documents that the EPA 
uses and relies upon. This regulation will improve the ability of 
members of the public to more easily identify all the guidance 
documents that the EPA uses and relies upon, resolving any concerns 
over the difficulty assessing the final and effective guidance of the 
Agency.
    Well-designed guidance documents can serve many important functions 
in regulatory programs. The EPA may provide guidance to interpret 
existing law or to clarify how it intends to implement a legal 
requirement. Additionally, EPA may generate guidance that sets forth a 
policy on a statutory, regulatory, or technical issue. Guidance 
documents, when used properly, can also help increase efficiency, and 
improve the public's understanding of the EPA's policies. Over reliance 
on guidance, to the exclusion of rulemaking, however, decreases the 
transparency of Agency implementation of legal requirements and can 
lead to inequitable outcomes.
    On October 9, 2019, the President signed E.O. 13891, ``Promoting 
the Rule of Law Through Improved Agency Guidance Documents.'' E.O. 
13891 directs Federal agencies to finalize regulations that ``set forth 
processes and procedures for issuing guidance documents.'' \2\ E.O. 
13891 notes that ``Americans deserve an open and fair regulatory 
process that imposes new obligations on the public only when consistent 
with applicable law and after an agency follows appropriate 
procedures.'' \3\ A central principle of E.O. 13891 is that guidance 
documents should clarify existing obligations only; they should not be 
a vehicle for implementing new, binding requirements on the public. 
E.O. 13891 recognizes that these documents, when designated as 
significant guidance documents, could benefit from public input prior 
to issuance. On October 31, 2019, the White House Office of Management 
and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) 
issued a memorandum to Federal agencies outlining how to implement, 
E.O. 13891.\4\
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    \2\ See section 4(a) of Executive Order 13891 (October 15, 2019; 
84 FR 55237).
    \3\ See section 1 of Executive Order 13891 (84 FR 55235).
    \4\ Guidance Implementing Executive Order 13891, Dominic J. 
Mancini, Acting Director, OIRA, October 31, 2019, (M-20-02).
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    Consistent with E.O. 13891 and OMB's implementing memorandum, this 
action proposes the EPA's procedures for developing and issuing 
guidance documents and to establish a petition process for public 
requests to modify or withdraw an active guidance document. The purpose 
is to ensure that the EPA's guidance documents are:
     Developed with appropriate review;
     Accessible and transparent to the public; and,
     Provided for public participation in the development of 
significant guidance documents.
    Implementing these procedures will lead to enhanced transparency 
and help to ensure that guidance documents are not improperly treated 
as legally binding requirements by the EPA or by

[[Page 31106]]

the regulated community. Moreover, the proposed regulation includes a 
definition of ``guidance document'' to provide greater clarity to the 
public regarding the scope of the proposed regulation.
    Specifically, consistent with the E.O., this regulation provides 
that the EPA will use an online portal to clearly identify EPA guidance 
documents for the public and proposes to establish: Definitions of 
``guidance document'' and ``significant guidance document,'' standard 
elements for such guidance documents and significant guidance 
documents, procedures for the EPA to enable the public to comment on 
proposed significant guidance documents, and procedures for the public 
to request that an active guidance document be modified or withdrawn. 
The EPA intends that this regulation be interpreted and implemented in 
a manner that, consistent with the goals of improving the Agency's 
accountability and the transparency of the EPA's guidance documents, 
provides appropriate flexibility for the EPA to take those actions 
necessary to accomplish its mission.

III. Guidance Document Procedures

    This rule proposes to establish the EPA's internal policies and 
procedures for the issuance of future guidance documents pursuant to 
the directives included in E.O. 13891 as well as codify the requirement 
that the Agency maintain an internet portal with all active and 
effective guidance of the Agency. The procedures contained in this 
proposed rule would apply to guidance documents issued by the EPA that 
are subject to the requirements of E.O. 13891 but not excluded under 
Section 4(b) of the E.O., as described in Unit III.A below. Section 
4(b) of the E.O. directs the Administrator of OIRA to issue memoranda 
establishing exceptions from the E.O. 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. The EPA is proposing that the 
procedures established in this rule would not apply to guidance 
documents excepted from the requirements of E.O. 13891 under Section 
4(b) of the E.O.

A. Definition of Guidance Document and Significant Guidance Document 
(Proposed 40 CFR 2.503)

    Consistent with the definitions in E.O. 13891 and OMB's 
implementing memorandum, the EPA is proposing the following definitions 
of the terms ``guidance document'' and ``significant guidance 
document.''
    1. Guidance Document. For the purposes of this rule, ``guidance 
document'' would 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. The definition 
is subject to the following exclusions:
     Rules promulgated pursuant to notice and comment under 5 
U.S.C. 553, or similar statutory provisions;
     Rules exempt from rulemaking requirements under section 5 
U.S.C. 553(a); \5\
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    \5\ 5 U.S.C. 553(a) applies, except to the extent that there is 
involved: (1) A military or foreign affairs function of the United 
States; or (2) a matter relating to agency management or personnel 
or to public property, loans, grants, benefits, or contracts.
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     Rules of Agency organization, procedure, or practice;
     Decisions of Agency adjudications under 5 U.S.C. 554, or 
similar statutory provisions;
     Internal guidance directed to the EPA or its components or 
other agencies that is not intended to have substantial future effect 
on the behavior of regulated parties;
     Agency 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;
     Agency 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'' Agency 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 the 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.
    2. Significant Guidance Document. For the purposes of this rule, 
``significant guidance document'' would mean a guidance document 
determined to be significant pursuant to E.O. 12866 and E.O. 13891.
    Section 2(c) of E.O. 13891 defines ``significant guidance 
document'' to mean a guidance document 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; (ii) Create a serious inconsistency or 
otherwise interfere with an action taken or planned by another agency; 
(iii) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or, (iv) Raise novel legal or policy issues arising out of 
legal mandates, the President's priorities, or the principles of E.O. 
12866.\6\
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    \6\ See section 2(c) of Executive Order 13891 (84 FR 55236).
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B. Inventory of Active Guidance Documents (Proposed 40 CFR 2.504)

    Section 3(a) of E.O. 13891 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 the EPA expects to cite, use, or rely upon. The EPA 
Guidance Portal was made publicly available on February 28, 2020 
(https://www.EPA.gov/guidance).\7\ The E.O. 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.
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    \7\ ``Notice of Public Guidance Portal,'' (85 FR 11986, February 
28, 2020).
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    The EPA is providing here a description of the information that is 
currently available on the EPA Guidance Portal. The EPA Guidance Portal 
following information for each guidance document:
     A concise name for the guidance document;
     The date on which the guidance document was issued;
     The date on which the guidance document was posted to the 
Guidance Portal;
     An EPA unique identifier;
     A hyperlink to the guidance document and any supporting or 
ancillary documents;

[[Page 31107]]

     The general topic, program, and/or statute addressed by 
the guidance document; and
     A brief summary of the guidance document's content.
    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) the Agency 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 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.\8\
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    \8\ See Q12 in Guidance Implementing Executive Order 13891, 
Dominic J. Mancini, Acting Director, OIRA, October 31, 2019 (M-20-
02).
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C. General Requirements and Procedures for Issuance of All Guidance 
Documents (Proposed 40 CFR 2.505)

    Consistent with E.O. 13891, the EPA proposes to require certain 
standard elements for all guidance documents issued after this rule is 
finalized. Specifically, the EPA is proposing to require that each 
guidance document would satisfy the following: \9\
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    \9\ See Q22 in Guidance Implementing Executive Order 13891, 
Dominic J. Mancini, Acting Director, OIRA, October 31, 2019, (M-20-
02).
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     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 CFR 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 the 
Agency 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, the EPA will make that clear in the document.\10\
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    \10\ See Q20 in Guidance Implementing Executive Order 13891, 
Dominic J. Mancini, Acting Director, OIRA, October 31, 2019, (M-20-
02).
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    Consistent with the requirements of E.O. 13891 and OMB's 
implementing memorandum, each new guidance document will be posted in 
the EPA Guidance Portal upon issuance.\11\ When a new guidance document 
has been issued, or an active guidance document has been modified, or 
an active guidance document has been withdrawn, the EPA proposes to 
inform the public via the EPA Guidance Portal or other Agency website. 
The EPA solicits 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. Note that specific procedures for announcing new, modified, 
or withdrawn significant guidance documents are discussed in Unit 
III.D. of this document.
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    \11\ See section 3(b) of Executive Order 13891 (84 FR 55236). 
See Q9-Q12 in Guidance Implementing Executive Order 13891, Dominic 
J. Mancini, Acting Director, OIRA, October 31, 2019, (M-20-02).
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    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 the EPA 
of positions advanced by affected private parties. For example, a 
guidance document may explain how the EPA believes a statute or 
regulation applies to certain regulated entities or activities. As a 
practical matter, the EPA 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.\12\
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    \12\ Final Bulletin for Agency Good Guidance Practices (72 FR 
3432, 3436).
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    Before issuing a new guidance document covered by this rule that is 
developed by an EPA Regional Office, the EPA is proposing 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.
    The EPA will seek significance determinations from OIRA for certain 
guidance documents, as appropriate, in the same manner as for 
rulemakings.

D. Requirements for Issuance of Significant Guidance Documents 
(Proposed 40 CFR 2.506)

    In addition to all the requirements described in Unit III.C., and 
consistent with the requirements of E.O. 13891, the EPA is proposing 
specific requirements for significant guidance documents.
    The EPA does not intend to supersede non-conflicting internal 
policy and procedures that the EPA established for significant guidance 
documents in 2007 as part of its implementation of the OMB Bulletin for 
Agency Good Guidance Practices.\13\ Specifically, the EPA is proposing 
the following additional requirements for significant guidance 
documents.
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    \13\ Final Bulletin for Agency Good Guidance Practices (72 FR 
3432).
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    1. Notice and Public Comment Opportunities. This 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. The EPA is 
proposing to generally require the EPA to 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. 
It also proposes to require the EPA to 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 finalizing the modification or withdrawal of 
such a document. In addition to the published announcement of the 
availability of the draft significant guidance document, the draft 
significant guidance document itself (including a link to any 
supporting documents) would be posted on the EPA's website concurrently 
and labeled appropriately.\14\ To ensure comments will be received and 
responded to by the EPA, public comments on draft significant guidance 
documents and draft modifications or withdrawals of

[[Page 31108]]

significant active guidance documents should be submitted using the 
methods specified in the Notice in the Federal Register announcing the 
availability of the draft significant guidance document or its 
withdrawal.
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    \14\ See section 4(a)(iii)(A) of Executive Order 13891 (84 FR 
55237), and Q23 in Guidance Implementing Executive Order 13891, 
Dominic J. Mancini, Acting Director, OIRA, October 31, 2019, (M-20-
02).
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    All comments received on a draft significant guidance document, or 
draft modification or withdrawal of an active significant guidance 
document, would be made available to the public either through the 
Federal eRulemaking Portal (i.e., https://www.regulations.gov/) or on 
the EPA website.
    2. Finalizing significant guidance documents. The EPA is proposing 
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 finalized.
    The proposed regulations would also require the 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 Notice in the 
Federal Register how the public may access the comments received and 
the Agency's response.
    The EPA solicits 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's Guidance Portal or 
other Agency website, could be used to announce such actions.
    3. Procedural exceptions. The EPA proposes limited exceptions to 
the significant guidance document notice and comment process. The EPA 
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 the EPA to immediately 
issue the document.\15\ Further, the 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. The EPA 
would present the good cause finding in the guidance document or notice 
of availability in the Federal Register.
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    \15\ See section 4(a)(iii)(A) of Executive Order 13891 (84 FR 
55237) and Final Bulletin for Agency Good Guidance Practices. (72 FR 
3432; 3438-3439).
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    4. 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.\16\
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    \16\ See section 4(a)(iii)(B) of Executive Order 13891 (84 FR 
55237) and, Q25 in Guidance Implementing Executive Order 13891, 
Dominic J. Mancini, Acting Director, OIRA, October 31, 2019, (M-20-
02).
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    5. Compliance with other applicable requirements. Section 5 of E.O. 
13891 specifies that significant guidance documents must demonstrate 
compliance with the requirements of E.O. 12866, ``Regulatory Planning 
and Review;'' E.O. 13563, ``Improving Regulation and Regulatory 
Review;'' and E.O. 13609, ``Promoting International Regulatory 
Cooperation,'' consistent with the requirements of section 4 of E.O. 
13891. E.O. 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, the EPA would comply with the requirements of 
Executive Orders 12866, 13563, 13609, and 13891 when issuing 
significant guidance documents. For example, the 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.\17\ 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.\18\ The 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).
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    \17\ See Q5 in Guidance Implementing Executive Order 13891, 
Dominic J. Mancini, Acting Director, OIRA, October 31, 2019, (M-20-
02).
    \18\ EPA Guidelines for Preparing Economic Analyses. December 
17, 2010 (updated May 2014). Accessible at https://www.epa.gov/sites/production/files/2017-08/documents/ee-0568-50.pdf.
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E. Procedures for Public To Petition for Modification or Withdrawal 
(Proposed 40 CFR 2.507)

    Consistent with E.O. 13891, the EPA is proposing procedures to 
allow the public to petition the EPA 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 to the 
public regarding how to request the modification or withdrawal of an 
active guidance document. The EPA is proposing that 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.
    1. Format and content elements for public petitions. The EPA is 
proposing the following formatting elements for petitions:
     The petitioner's name and a means for the EPA to contact 
the petitioner such as an email 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.''
    The EPA is proposing 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 the Agency to consider; and
     A rationale for the requested modification or withdrawal.
    Although the EPA may be able to consider incomplete petitions, 
petitions that omit the specified information may impede the EPA from 
fully evaluating the merits of the requested action. The EPA is 
proposing 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. The EPA notes that if a document does not 
include all of the format and content

[[Page 31109]]

elements described above, the EPA 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 the EPA, and any 
suggestions contained in it will be considered at the discretion of the 
Administrator.
    The EPA solicits 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. The EPA 
requests that any such comments explain how additional information 
elements would enable the Agency to correctly identify and more 
completely evaluate a petition.
    2. Required EPA response to public petitions. The EPA would respond 
to petitions in a timely manner, but no later than 90 calendar days 
after receipt of the petition. If the EPA requires more than 90 
calendar days to consider a petition, the EPA would inform the 
petitioner that more time is required and indicate the reason why and 
provide an estimated decision date. The EPA will only extend the 
response date one time for a period not to exceed 90 calendar days 
before providing a response.
    It 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 the Agency agrees with 
a petitioner seeking a modification to a guidance document, the Agency 
will pursue the modification in accordance with applicable procedures. 
In such cases, the Agency intends for the response to the petition to 
include its approach for completing the modification of that guidance 
document.
    Duplicative petitions and petitions submitted as part of a mass 
petitioning effort may be responded to in a single response to ensure 
an efficient and consistent response to the petitions. Petitions that 
request a change to the underlying statute or promulgated rules, rather 
than specific text in the guidance document, will not be considered 
valid petitions under this process because they are not petitions to 
modify or withdraw a guidance document.
    The EPA requests comment on whether the Agency 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 APA section 553(e).\19\
---------------------------------------------------------------------------

    \19\ (Pub. L. 89-554, Sept. 6, 1966, 80 Stat. 383.)
---------------------------------------------------------------------------

IV. Statutory and Executive Orders Reviews

    Additional information about these statues and Executive orders can 
be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was 
therefore not submitted to OMB for review under Executive Orders 12866. 
The EPA does not anticipate that this rulemaking will have an economic 
impact on regulated entities. This is a rule of agency procedure and 
practice. The EPA expects the benefits of this rule to be improved 
transparency and management of the EPA's guidance documents.

B. Executive Order 13771: Reducing Regulations and Controlling 
Regulatory Costs

    This action is not expected to be an Executive Order 13771 
regulatory action because it relates to ``agency organization, 
management or personnel.''

C. Paperwork Reduction Act (PRA)

    This action does not contain any information collection activities 
and therefore does not impose an information collection burden under 
the PRA.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA. This is 
a rule of agency procedure and practice. The EPA expects the benefits 
of this rule to be improved transparency and management of the EPA's 
guidance documents.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in 
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect 
small governments. The action imposes no enforceable duty on any state, 
local, or tribal governments or the private sector.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have 
substantial direct effects on the states, on the relationship between 
the National Government and the states, or on the distribution of power 
and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this action.

H. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that concern environmental health or safety risks 
that the EPA has reason to believe may disproportionately affect 
children. Per the definition of ``covered regulatory action'' in 
section 2-202 of Executive Order 13891 and because this action does not 
concern an environmental health risk or safety risk, it is not subject 
to Executive Order 13045.

I. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is 
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action is not subject to Executive Order 
12898 (59 FR 7629, February 16, 1994) because it does not establish an 
environmental health or safety standard.

List of Subjects in 40 CFR Part 2

    Environmental protection, Administrative practice and procedure, 
Organization and functions (Government agencies).

Andrew Wheeler,
Administrator.

    For the reasons set forth in the preamble, the Environmental 
Protection Agency proposes to amend 40 CFR part 2 as follows:

[[Page 31110]]

PART 2--PUBLIC INFORMATION

0
1. The authority citation for part 2 continues to read as follows:

    Authority:  5 U.S.C. 301, 552, 552a, 553; 28 U.S.C. 509, 510, 
534; 31 U.S.C. 3717.

0
2. Add subpart D to read as follows:

Subpart D--Guidance Procedures

Sec.
2.501 General.
2.502 Scope.
2.503 Definitions.
2.504 Public access to active guidance documents.
2.505 Guidance document general requirements and procedures.
2.506 Significant guidance document requirements and procedures.
2.507 Procedures for the public to petition for modification or 
withdrawal.


Sec.  2.5012.501  General.

    This subpart establishes procedures for the issuance of EPA 
guidance documents subject to Executive Order 13891, ``Promoting the 
Rule of Law Through Improved Agency Guidance Documents'' (October 15, 
2019). This subpart also establishes procedures for the public to 
petition for modification or withdrawal of such guidance documents.


Sec.  2.502  Scope.

    (a) The procedures in this subpart do not apply to guidance 
documents excepted from the requirements of Executive Order 13891 under 
Section 4(b) of the Executive order or that are not otherwise subject 
to Executive Order 13891.
    (b) Subject to the qualifications and exemptions contained in this 
subpart, the procedures in this subpart apply to all active guidance 
documents as defined in this subpart, issued by all components of the 
Environmental Protection Agency (EPA) after [date of issuance for the 
final rule].
    (c) Rescinded guidance documents are not active guidance documents 
pursuant to Executive Order 13891 and may only be used to establish 
historical facts.
    (d) This subpart is intended to improve the internal management of 
the EPA. As such, it 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.
    (e) If Executive Order 13891, or any provision thereof, is 
rescinded or superseded, this subpart remains in force.
    (f) The Agency may deviate from the procedures in this subpart, 
when necessary, at the written direction of the Administrator. The 
decision to deviate from the procedures in this subpart is in the 
Administrator's sole and unreviewable discretion.


Sec.  2.503  Definitions.

    For the purposes of this subpart, the following definitions apply:
    Guidance document means 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, 
subject to the following exclusions:
    (1) Rules promulgated pursuant to notice and comment under 5 U.S.C. 
553, or similar statutory provisions;
    (2) Rules exempt from rulemaking requirements under 5 U.S.C. 
553(a);
    (3) Rules of Agency organization, procedure, or practice;
    (4) Decisions of Agency adjudications under 5 U.S.C. 554, or 
similar statutory provisions;
    (5) Internal guidance directed to the EPA or its components or 
other agencies that is not intended to have substantial future effect 
on the behavior of regulated parties;
    (6) Internal executive branch legal advice or legal opinions 
addressed to executive branch officials or courts, including legal 
opinions by the Office of General Counsel;
    (7) Agency statements of specific, rather than general, 
applicability. This would exclude from the definition of ``guidance'' 
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 unless a document is directed to a particular 
party but designed to guide the conduct of the broader regulated 
public;
    (8) Agency statements that do not set forth a policy on a 
statutory, regulatory, or technical issue or an interpretation of a 
statute or regulation, including news updates like speeches and press 
releases, as well as statements of general applicability concerning 
participation in the EPA's voluntary programs;
    (9) Legal briefs and other court filings;
    (10) Grant solicitations and awards; or
    (11) Contract solicitations and awards.
    Significant guidance document means a guidance document that is 
determined to be ``significant'' pursuant to Executive Order 12866 and 
Executive Order 13891.


Sec.  2.504  Public access to active guidance documents.

    All active guidance documents shall appear on the EPA Guidance 
Portal on the EPA website.


Sec.  2.505  Guidance document general requirements and procedures.

    (a) Minimum guidance requirements. In each guidance document, the 
EPA will:
    (1) Include the term ``guidance'';
    (2) Identify the component office issuing the document;
    (3) Provide the title of the guidance and the document 
identification number;
    (4) Include the date of issuance;
    (5) When practicable, identify the general activities to which and 
the persons to whom the document applies;
    (6) Include the citation to the statutory provision (including the 
U.S.C. citation) or regulation (to the CFR) to which the guidance 
document applies or which it interprets;
    (7) 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;
    (8) Include a short summary of the subject matter covered in the 
guidance document at the beginning of the document; and
    (9) Include a disclaimer stating that the contents of the guidance 
document do not have the force and effect of law and that the Agency 
does not bind the public in any way and intends only to provide clarity 
to the public regarding existing requirements under the law or Agency 
policies, except as authorized by law or as incorporated into a 
contract. When a guidance document is binding because binding guidance 
is authorized by law or because the guidance is incorporated into a 
contract, the statement will reflect that.
    (b) Approval. A guidance document issued by an 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.
    (c) Avoid mandatory language. A guidance document will avoid 
mandatory language such as ``shall,'' ``must,'' ``required'' or 
``requirement,'' unless using these words to describe a statutory or 
regulatory requirement, or the language is addressed to EPA staff and 
will not foreclose consideration by the EPA of positions advanced by 
affected private parties.

[[Page 31111]]

    (d) Significance determinations. The EPA will seek significance 
determinations from the Office of Information and Regulatory Affairs 
(OIRA) for certain guidance documents, as appropriate, in the same 
manner as for rulemakings.


Sec.  2.506  Significant guidance document requirements and procedures.

    A significant guidance document will adhere to all the requirements 
described in Sec.  2.505 and the requirements in this section.
    (a) Draft for public comment. (1) The EPA will make available a 
draft significant guidance document, or draft modification or 
withdrawal of a significant active guidance document, for public 
comment before finalizing any significant guidance document. The EPA 
will post appropriately labeled draft guidance and any supporting 
documents on the EPA's website.
    (2) The EPA will publish a notice in the Federal Register 
announcing the availability of a draft significant guidance document, 
or draft modification or withdrawal of a significant active guidance 
document, to open the public comment period.
    (b) Public comment process. (1) Except as provided in paragraph (c) 
of this section, a draft significant guidance document, or a draft 
modification or withdrawal of a significant active guidance document, 
will have a minimum of 30 days public notice and comment before 
issuance of a final guidance document or issuance of the final 
modification or withdrawal of an active guidance document. Public 
comments shall be available to the public online, either in a docket or 
on the EPA website.
    (2) The EPA shall respond to major concerns and comments in the 
final guidance document itself or in a companion document.
    (c) Exceptions to comment process. The EPA will not seek or respond 
to public comment before the EPA implements a significant guidance 
document if at the sole discretion of the Administrator:
    (1) Doing so is not feasible or appropriate because immediate 
issuance is required by a public health, safety, environmental, or 
other emergency requiring immediate issuance of the guidance document 
or a statutory requirement or court order that requires immediate 
issuance; or
    (2) When the Agency for good cause finds (and incorporates such 
finding and a brief statement of reasons therefor into the guidance 
document) that notice and public comment thereon are impracticable, 
unnecessary, or contrary to the public interest.
    (d) Additional notices. The EPA also will publish a notice in the 
Federal Register when it finalizes a significant guidance document or 
finalizes a modification or withdrawal of a significant active guidance 
document.
    (e) Approval. The EPA Administrator or other Presidentially-
appointed EPA official, or an official who is serving in the acting 
capacity of either of the foregoing, will approve a significant 
guidance document prior to its issuance and posting in the EPA Guidance 
Portal website.
    (f) Executive order compliance. A significant guidance document 
shall comply with the requirements of Executive Orders 12866, 13563, 
13609, 13771, 13777, and 13891.


Sec.  2.507  Procedures for the public to petition for modification or 
withdrawal.

    (a) Submission of a petition. The public may submit a petition to 
the EPA for the modification or withdrawal of an active guidance 
document.
    (b) Petition methods. A petitioner should only submit a petition to 
the EPA using one of the two methods in paragraphs (b)(1) and (2) of 
this section and not submit additional copies by any other method. A 
petition should be submitted through:
    (1) An electronic submission through the EPA's designated 
submission system identified on the EPA Guidance Portal website; or
    (2) A paper submission to the EPA's designated mailing address 
listed on the EPA Guidance Portal website.
    (c) Petition format. A petition under this section should include:
    (1) The petitioner's name and a means for the EPA to contact the 
petitioner such as an email address or mailing address, in addition to 
any other contact information (such as telephone number) that the 
petitioner chooses to include; and
    (2) A heading, preceding its text that states, ``Petition to Modify 
a Guidance Document'' or ``Petition to Withdraw a Guidance Document.''
    (d) Petition content. A petition for modification or withdrawal of 
an active guidance document should include the following elements:
    (1) Identification of the specific title and the EPA unique 
identifier of the guidance document that the petitioner is requesting 
be modified or withdrawn;
    (2) The nature of the relief sought (i.e., modification or 
withdrawal);
    (3) An explanation of the interest of the petitioner in the 
requested action (i.e., modification or withdrawal);
    (4) 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
    (5) A rationale for the requested modification or withdrawal.
    (e) Petition handling. Failure to follow one of the submission 
methods described in paragraph (b) of this section and to include in a 
petition the elements in paragraphs (c) and (d) of this section may 
create delays in processing time and may result in the EPA being unable 
to evaluate the merits of the petition.
    (1) The EPA may treat a petition that is not submitted as specified 
in paragraph (b) of this section, but that meets the other elements of 
this section, as a properly filed petition and received as of the time 
it is discovered and identified.
    (2) The EPA may treat a document that fails to conform to one or 
more of the elements of paragraphs (c) and (d) of this section as if it 
is not a petition under this section. The EPA may treat such a document 
according to the existing correspondence or other appropriate 
procedures of the EPA, and any suggestions contained in it will be 
considered at the discretion of the Administrator.
    (f) Petition response timing. (1) The EPA should respond to a 
petition in a timely manner, but no later than 90 calendar days after 
receipt of the petition.
    (2) If, for any reason, the EPA needs more than 90 calendar days to 
respond to a petition, the EPA will inform the petitioner that more 
time is needed and indicate the reason why and an estimated response 
date. The EPA will only extend the response date one time not to exceed 
90 calendar days before providing a response.
    (g) Petition response. (1) The EPA may provide a single response to 
issues raised by duplicative petitions and petitions submitted as part 
of a mass petitioning effort.
    (2) In order to be considered a valid petition under this section, 
the petition must address a specific issue in the guidance document in 
question and not merely underlying statutory or regulatory text.

[FR Doc. 2020-11079 Filed 5-21-20; 8:45 am]
 BILLING CODE 6560-50-P