[Federal Register Volume 85, Number 202 (Monday, October 19, 2020)]
[Rules and Regulations]
[Pages 66230-66240]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20519]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 2

[EPA-HQ-OA-2020-0128, FRL-10014-91-OP]
RIN 2010-AA13


EPA Guidance; Administrative Procedures for Issuance and Public 
Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes the procedures and requirements 
for how the U.S. Environmental Protection Agency (EPA) will manage the 
issuance of guidance documents consistent with the Executive Order 
13891 entitled ``Promoting the Rule of Law Through Improved Agency 
Guidance Documents.'' Specifically, consistent with the Executive 
Order, this regulation provides a definition of guidance documents for 
the purposes of this rule, establishes general requirements and 
procedures for certain guidance documents issued by the EPA and 
incorporates additional requirements for guidance documents determined 
to be significant guidance. This regulation, consistent with the 
Executive Order, also provides procedures for the public to petition 
for the modification or withdrawal of active guidance documents as 
defined by this rule or to petition for the reinstatement of a 
rescinded guidance document. This regulation is intended to increase 
the transparency of the EPA's guidance practices and improve the 
process used to manage EPA guidance documents.

DATES: This final rule is effective on November 18, 2020.

ADDRESSES: The EPA has established a docket for this action under 
Docket ID No. EPA-HQ-OA-2020-0128. All documents in the docket are 
listed on the https://www.regulations.gov website. Although listed in 
the index, some information is not publicly available, e.g., CBI or 
other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available electronically 
through https://www.regulations.gov. For information on the 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: cooperstein.sharon@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. 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.

B. What action is the Agency taking?

    After considering the public comments received on the proposal, the 
EPA is finalizing procedures that the Agency will use to issue guidance 
documents as defined in this regulation. These new procedures satisfy 
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.
    Specifically, consistent with the E.O., this regulation provides 
that the EPA will use an online portal (the EPA Guidance Portal) to 
identify EPA guidance documents for the public and will establish: 
Definitions of ``guidance document,'' ``significant guidance 
document,'' and other key terms; standard elements for all guidance 
documents; additional requirements for significant guidance documents; 
procedures for the EPA to enable the public to comment on draft 
significant guidance documents; and procedures for the public to 
petition the Agency for modification or withdrawal of guidance 
documents.
    In this final rule, the EPA has revised some of the proposed 
requirements in response to public comments. Most notably, the EPA is 
adding the opportunity for the public to petition the Agency to 
reinstate guidance documents that were rescinded. In addition, the EPA 
will make information publicly available regarding petitions received 
pursuant to the petition procedures. To provide additional clarity, the 
final regulatory text includes new definitions of ``active guidance 
document'' and ``rescinded guidance document.'' Other minor edits to 
the regulatory text are also being finalized to increase clarity.

C. 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

[[Page 66231]]

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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    Consistent with the proposal, the EPA 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.
    The EPA received multiple public comments regarding the legal 
authority for this regulation. Several commenters expressed their 
concerns regarding the EPA citing the Federal Housekeeping Statute as 
the legal authority for the proposed rulemaking. For example, some 
commenters state that the Federal Housekeeping Statute does not confer 
any authority on the EPA to promulgate regulations because the EPA is 
not an ``executive department'' within the meaning of the statute. Even 
if the Federal Housekeeping Statute confers authority on the EPA, the 
commenters claim that this rulemaking exceeds the ``day-to-day office 
housekeeping'' authorized by the statute. These commenters disagree 
with the EPA that this rule is a procedural matter of ``internal 
management'' and claim that it is a substantive regulation that creates 
public rights and agency obligations. Further, the commenters state 
that opening the proposed rule to public comment contradicts the EPA's 
claims that the rule is ``internal management'' with no substantive 
effect.
    The EPA disagrees with these commenters. As the Supreme Court 
discussed in Chrysler Corp v. Brown, the intended purpose of 5 U.S.C. 
301was to grant early Executive departments the authority ``to govern 
internal departmental affairs.'' Chrysler Corp. v. Brown, 441 U.S. 281, 
309 (1979). As the Supreme Court further notes, section 301 authorizes 
``what the [Administrative Procedure Act] terms `rules of agency 
organization, procedure or practice' as opposed to substantive rules.'' 
Id. at 310.
    The EPA is not one of the 15 ``Executive Departments'' listed at 5 
U.S.C. 101. However, the EPA gained housekeeping authority through the 
Reorganization Plan No. 3 of 1970, 84 Stat. 2086 (July 9, 1970). The 
Reorganization Plan created the EPA, established the Administrator as 
``head of the agency[,]'' and transferred functions and authorities of 
various agencies and Executive departments to the EPA. Section 2(a)(1)-
(8) of the Reorganization Plan transferred to the EPA functions 
previously vested in several agencies and executive departments 
including the Departments of Interior and Agriculture. Section 2(a)(9) 
also transferred so much of the functions of the transferor officers 
and agencies ``as is incidental to or necessary for the performance by 
or under the Administrator of the functions transferred.'' The Federal 
Housekeeping Statute was existing law at the time the Reorganization 
Plan was enacted. Accordingly, the concomitant federal housekeeping 
authority to issue procedural rules was transferred to the EPA.
    The Office of Legal Counsel has opined that the Reorganization Plan 
``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.'' \2\
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    \2\ 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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    Courts have recognized the EPA to be an agency with section 301 
housekeeping authority. The U.S. Court of Appeals for the Second 
Circuit, in EPA v. General Elec. Co., 197 F.3d 592, 595 (2d Cir. 1999), 
found that ``the Federal Housekeeping Statute, 5 U.S.C. 301, authorizes 
government agencies such as the EPA to adopt regulations regarding `the 
custody, use, and preservation of [agency] records, papers, and 
property.' '' The Fourth Circuit Court of Appeals, in Boron Oil Co. v. 
Downie, 873 F.2d 67, 69 (4th Cir. 1989), held that the district court 
exceeded its jurisdiction where it compelled testimony by an Agency 
employee in a state court action to which the government was not a 
party, contrary to duly promulgated EPA regulations, which the EPA 
argued were authorized by section 301. Although the court assumed the 
EPA derived its housekeeping authority from 5 U.S.C. 301, these cases 
nonetheless recognized that the EPA had federal housekeeping authority. 
Indeed, if the EPA did not possess federal housekeeping authority, the 
EPA would not be able to carry out its daily functions, which would in 
turn preclude the EPA from exercising its duties as a federal 
regulatory agency. The same would hold true for other regulatory 
agencies that are not listed as an Executive department under 5 U.S.C. 
101.

II. Background and Purpose

    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.'' \3\ 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.'' \4\ 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.\5\
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    \3\ See section 4(a) of E.O. 13891 (October 15, 2019; 84 FR 
55237).
    \4\ See section 1 of E.O. 13891 (84 FR 55235).
    \5\ Guidance Implementing Executive Order 13891, Dominic J. 
Mancini, Acting Director, OIRA, October 31, 2019, (M-20-02).
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    On May 22, 2020, consistent with E.O. 13891 and OMB's implementing 
memorandum, the EPA proposed new procedures for developing and issuing 
guidance documents as defined in the proposed rule, and establishing a 
petition process for public requests to modify or withdraw an active 
guidance document.\6\ The purpose of this action is to ensure that the 
EPA's guidance documents are:
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    \6\ 85 FR 31104 (May 22, 2020).
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     Developed with appropriate review;
     Accessible and transparent to the public; and,
     Benefit from 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 the regulated 
community. Moreover, this regulation defines ``guidance document'' to 
provide greater clarity to

[[Page 66232]]

the public regarding the scope of documents subject to these 
procedures. This regulation will improve the ability of members of the 
public to identify the guidance documents that the EPA uses and relies 
upon, resolving any concerns over the difficulty assessing the final, 
effective, active guidance of the Agency.\7\
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    \7\ This regulation defines the term ``active guidance 
document'' to mean a guidance document in effect that the EPA 
expects to cite, use, or rely upon. The term active guidance 
document is synonymous with ``effective guidance document'' and 
``guidance in effect.'' Active guidance document is the term used on 
the EPA Guidance Portal website.
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    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 final rule establishes the EPA's internal policies and 
procedures for the issuance of future guidance documents pursuant to 
the directives included in E.O. 13891 and codifies the requirement that 
the Agency maintain an internet portal with a list of all effective, 
active EPA guidance documents meeting the definition in this 
regulation. The procedures contained in this final rule apply to 
guidance documents, as defined by this regulation, issued by the EPA 
and not excluded under Section 4(b) of E.O. 13891, as described in 
section III.A of this preamble.\8\ 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 procedures established in this rule do not apply to 
guidance documents excepted from the requirements of E.O. 13891 under 
Section 4(b) of the E.O., as interpreted by M-20-02, or otherwise 
excepted by the Administrator of OIRA.
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    \8\ The EPA issues 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'' in 
this regulation would qualify, regardless of name or format.
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A. Definition of Guidance Document and Significant Guidance Document 
(40 CFR 2.503)

    The EPA proposed definitions of the terms ``guidance document'' and 
``significant guidance document'' consistent with the definitions in 
E.O. 13891 and OMB's implementing memorandum, M-20-02. Several 
commenters provided strong support for the EPA's definition of 
``guidance document'' and stated that it is consistent with the 
targeted approach under E.O. 13891. The EPA agrees that the proposed 
definition is consistent with the E.O. 13891 definition.
    Other commenters expressed their concerns that the definition of 
``guidance document'' in this rulemaking does not provide sufficient 
clarity regarding what documents the EPA considers to be guidance 
documents subject to these requirements. A few commenters recommended 
that the EPA create three or more categories of EPA guidance documents, 
such as significant guidance documents, other important guidance 
documents on the EPA Guidance Portal, and other technical program 
guidance documents excluded from the EPA Guidance Portal. One commenter 
noted that the definition of ``guidance document'' could be interpreted 
to only encompass guidance documents that apply to regulated parties, 
not States, and recommended a revision to clarify applicability to 
States.
    The EPA disagrees that the definition of guidance document is 
unclear. The EPA adopted the definition of guidance document set forth 
in E.O. 13891 with only minor modifications and believes the listed 
exclusions are helpful in distinguishing the types of documents that do 
not meet the definition. In common parlance, guidance can refer to many 
types of documents issued by the EPA and other agencies. The EPA does 
not intend to use this rule to parse the various nomenclatures and 
types of guidance that it uses. The definition of a ``guidance 
document'' and ``significant guidance document'' as used in this rule 
are specific to this rule. To provide further clarity in the 
implementation of this rule, the EPA has also included definitions for 
``active guidance document'' and ``rescinded guidance document.'' 
Regarding the revision recommended by a commenter to clarify whether 
guidance documents can apply to States, the EPA disagrees with revising 
the proposed definition of guidance document. In some circumstances, 
States are regulated entities subject to EPA guidance documents while 
in other circumstances States are co-regulators. The EPA believes that 
the proposed definition adequately allows for this dual role of States.
    The EPA received comments regarding the meaning of ``active 
guidance document'' and ``rescinded guidance document.'' One commenter 
stated that the EPA should clarify what it means for a guidance 
document to be ``rescinded'' or ``in effect,'' as neither term was 
expressly defined in the proposed rule or explained in the preamble and 
clarifying would ensure that the public understands which guidance 
documents have legal effect. The commenter stated that the EPA should 
clarify that a ``rescinded'' guidance document is a guidance document 
that is not included on the EPA Guidance Portal and means that the EPA 
cannot ``cite, use, or rely on'' it as explaining regulatory 
requirement except to establish historical facts. The commenter stated 
that the EPA should clarify that a guidance document ``in effect'' is 
one that meets the proposal's definition of ``guidance document'' and 
is included in the EPA Guidance Portal, and thus means that the EPA may 
cite it.
    The EPA agrees that these definitions would increase clarity and 
transparency. Based on comments received, the EPA is adding definitions 
for ``active guidance document'' and ``rescinded guidance document.'' 
Specifically, the EPA is defining ``active guidance document'' in this 
rule as a guidance document or significant guidance document in effect 
that EPA expects to cite, use, or rely upon. Conversely, the EPA is 
defining a ``rescinded guidance document'' in section 2.503 as a 
document that would otherwise meet the definition of a guidance 
document or significant guidance document, but that the EPA may not 
cite, use, or rely upon except to establish historical facts. This 
definition was adopted from the proposed section 2.502(c).
    Several commenters provided comments regarding how the definition 
of guidance document applied to scientific and technical documents. 
Several commenters recommended that the definition of ``guidance 
document'' should not exclude scientific or technical determinations. 
For example, several commenters recommended that scientific assessments 
produced by the EPA's Integrated Risk Information System (IRIS) Program 
be included in the definition of guidance document. One commenter 
agreed with the EPA that health advisories are appropriately considered 
guidance with regards to the proposed rulemaking, while another

[[Page 66233]]

commenter specifically requested that the EPA clarify whether water 
quality criteria documents (CWA Sec. 304(a)) qualify as guidance 
documents or significant guidance. Another commenter recommended that 
the EPA either clearly state that scientific documents are not covered 
by this rule or post all of the scientific documents that the EPA has 
relied on since 2008 on the EPA Guidance Portal.
    EPA defines ``guidance document'' consistent with the definitions 
in E.O. 13891 and OMB's implementing memorandum, which includes the 
term ``technical issue.'' Furthermore, for purposes of this rule, the 
EPA considers the term ``scientific'' to be a subset of ``technical.'' 
As such, the EPA has determined that the definition of ``guidance 
document'' includes certain scientific and/or technical documents. For 
example, the EPA has determined that drinking water health advisories 
and CWA 304(a) national recommended Water Quality Criteria issued by 
the Office of Water 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. However, EPA releases a great 
deal of technical information (including scientific information) that 
would not be subject to this regulation 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. Due to the diversity of 
purpose and content of scientific and technical documents, it would be 
inconsistent with E.O. 13891 for the EPA to categorically determine 
whether all scientific and technical documents are ``guidance 
documents.''

B. Inventory of Active Guidance Documents (40 CFR 2.504)

    The EPA proposed that all active guidance documents issued by the 
Agency must be included on the EPA Guidance Portal,\9\ The EPA Guidance 
Portal was initially made publicly available on February 28, 2020, and 
was fully populated to include all active guidance documents on July 
31, 2020. Starting on the effective date of this rule, as per section 
2.504 of this final rule, all active guidance documents shall appear on 
the EPA Guidance Portal on the EPA website. Any guidance document (as 
defined in this regulation) 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.
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    \9\ The EPA Guidance Portal is available at https://www.EPA.gov/guidance.
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    The EPA proposed to inform the public via the EPA Guidance Portal 
that a new guidance document has been issued, an active guidance 
document has been modified, or an active guidance document has been 
withdrawn. The EPA solicited and received several comments related to 
the EPA Guidance Portal, the requirement for all active guidance to be 
on the EPA Guidance Portal, and the utility of using the EPA Guidance 
Portal 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.
    Most commenters supported the creation and use of the EPA Guidance 
Portal to maintain a consolidated online portal with lists of active 
guidance documents as an important method for the Agency to promote 
transparency, fairness, consistency, and regulatory compliance. One 
commenter stated that the EPA Guidance Portal will be especially 
helpful for smaller businesses with limited resources and personnel for 
regulatory compliance.
    The EPA agrees with commenters that the establishment of the EPA 
Guidance Portal is an important achievement in promoting greater 
transparency with respect to the Agency's guidance documents.
    Several commenters noted that it is difficult for an interested 
party to ascertain whether a document is not on the EPA Guidance Portal 
because it does not meet the definition of a guidance document or 
because it has been rescinded. Some commenters recommended that the EPA 
include new sections on the EPA Guidance Portal for documents that the 
EPA has determined not to be a ``guidance document'' and for guidance 
documents that are rescinded. One commenter suggested that the EPA 
could include a select list of rescinded guidance documents that would 
be of broad interest, another suggested a list of rescinded guidance 
documents would be helpful even if not comprehensive. One commenter 
recommended that the EPA be over-inclusive in its initial listing so 
that no essential guidance gets accidently rescinded. Commenters 
requested that the EPA clarify when and the manner in which non-Agency 
parties may continue to rely on guidance that are not posted to the EPA 
Guidance Portal, and clarify that external parties are not subject to 
the same prohibition on citing, using, or relying on such guidance as 
the EPA.
    The EPA will work to continually improve the transparency of the 
EPA Guidance Portal, including exploring ways to inform the public of 
the status of documents not included on the EPA Guidance Portal. The 
EPA recommends that questions regarding specific guidance documents 
omitted from the EPA Guidance Portal should be directed to the relevant 
EPA program or regional office that issued the document.
    Regarding the status of rescinded guidance documents, it is 
important to note that this rule only specifies the procedures that the 
Agency will follow. The EPA believes the proposed regulation was clear 
that the Agency could not rely on a rescinded guidance document except 
to establish historical facts. This regulation is not intended to 
affect the Agency's past actions that relied upon EPA guidance 
documents that are now rescinded; decisions made by the Agency are not 
invalidated because guidance used in reaching those decisions is now 
rescinded. Notwithstanding the general prohibition on EPA's use of 
rescinded guidance documents, the EPA cannot limit how non-Agency 
parties use rescinded guidance, as long as they do not represent 
rescinded guidance documents as current Agency policy.
    Several commenters noted that the EPA Guidance Portal was missing 
specific documents or classes of documents or that it contained 
documents that should not be considered active guidance documents.
    During the public comment period for this rule, the EPA Guidance 
Portal had not yet been fully populated, so some situations involving 
purportedly missing documents may have been resolved in the intervening 
time. The dispensation of specific documents on the EPA Guidance Portal 
is outside the scope of this rulemaking. The EPA recommends that any 
such questions regarding specific guidance documents should be directed 
to the relevant EPA program or regional office that issued the 
document. Additionally, as discussed in section III.E in this preamble, 
the EPA is adopting in section 2.507 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.
    Many commenters provided suggestions to improve the usability and 
functionality of the EPA Guidance Portal, for example, by making it 
easier to do a single search across all agency guidance. Suggestions 
included improving the search functionality across programs, adding 
automated notifications for new or modified

[[Page 66234]]

documents (e.g., subscribed email lists or listservs), using visual 
flags to denote changes or additions, curating the list into statutory 
or programmatic categories. One commenter opposed using the EPA 
Guidance Portal as the only source of information regarding new or 
modified guidance.
    The EPA agrees with commenters that the usability and functionality 
of the EPA Guidance Portal could be improved. In consideration of these 
comments, the EPA will continue to evaluate and work to improve the 
functionality of the EPA Guidance Portal, such as improving search 
capabilities and notification mechanisms.
    After consideration of these comments and consistent with the 
requirements of E.O. 13891, the EPA is finalizing the requirement 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 EPA Guidance Portal does not 
represent an active guidance document (as defined in this regulation) 
of the Agency and will have no effect, as proposed.\10\ When a new 
guidance document is issued, or an active guidance document is 
modified, or an active guidance document is withdrawn, the EPA will 
inform the public via the EPA Guidance Portal.
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    \10\ See section 3(b) of E.O. 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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    The EPA agrees that the EPA Guidance Portal is the most effective 
method to notify the public of changes to the list of active guidance 
documents because it provides the ability to sort or search by the most 
current date so that newly added or modified guidance documents appear 
at the top of the list. The EPA will work to improve the functionality 
of the Portal and will consider additional means of notifying the 
public of changes to the list of guidance documents in the future. In 
addition, the EPA will explore ways to inform the public of the status 
of documents not included on the EPA Guidance Portal.
    As stated 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'' as defined in this regulation. 
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 in this regulation excludes, among 
others, internal guidance directed to the 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. 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.''
    As noted in the proposal, the EPA Guidance Portal currently 
provides the 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;
     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. As noted in the preamble to the 
proposed regulation, the EPA Guidance Portal will also include a link 
to this final regulation after publication in the Federal Register as 
well as to any future proposed or final amendments.\11\
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    \11\ The EPA Guidance Portal is available at https://www.EPA.gov/guidance.
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C. General Requirements and Procedures for Issuance of All Guidance 
Documents (40 CFR 2.505)

    The EPA proposed to require certain standard elements for all 
guidance documents issued after the effective date of this final rule, 
consistent with E.O. 13891. Specifically, the 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.
    The EPA received comments that were generally supportive of the 
minimum required elements for guidance documents. Several commenters 
supported the proposed disclaimer that clarifies that guidance 
documents are non-binding, would not have the force and effect of law, 
and are intended to clarify existing requirements. A few commenters 
recommended additional required elements, such as identification of an 
EPA contact person for the guidance document.
    The EPA acknowledges the support for the minimum elements from most 
commenters but disagrees that the additional recommended elements would 
be appropriate to require for all guidance documents at this time. For 
example, the identification of a specific EPA contact person would 
become less useful over time, as individual staff change positions or 
leave the Agency. Instead, the requirement to identify the issuing 
office will provide sufficient transparency for the public to contact 
the Agency regarding the guidance. The EPA believes the current set of 
elements strikes the appropriate balance between consistency and 
flexibility.
    Most commenters supported the proposed requirement that guidance 
documents refrain from using mandatory language. Consistent with these 
comments, the EPA is finalizing the proposed requirement 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 the EPA of positions advanced by 
affected private parties.
    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

[[Page 66235]]

before issuing a new guidance document developed by an EPA Regional 
Office. Therefore, the EPA is finalizing this concurrence requirement 
as proposed.
    For significant guidance documents, the EPA proposed to require 
public notice in the Federal Register and a minimum 30-day comment 
period. However, several commenters recommended that the EPA expand the 
notice and comment requirement to cover most or all guidance covered by 
this rulemaking, 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.
    The EPA disagrees that it is necessary to expand the notice and 
comment requirements for significant guidance documents to all guidance 
documents. As stated in the proposal preamble, the EPA has the 
authority to seek comment on any document that the Agency determines 
would benefit from public input and would do so when appropriate. In 
addition, all active guidance documents that meet the definition in 
this rulemaking will be available on the EPA Guidance Portal, and the 
public can petition the Agency to modify or rescind any of these 
guidance documents. Further, the EPA agrees that applying the notice 
and comment requirements to non-significant guidance could delay 
issuance. For these reasons, the EPA declines to expand the notice and 
comment requirement to all guidance documents.
    Regarding determinations of whether a guidance document qualifies 
as significant, a few commenters requested clarification on the process 
that will be used to identify a guidance document as a significant 
guidance document. The EPA disagrees that more details on this process 
are required and believes that the regulation is clear. The EPA is 
finalizing the proposed requirement to seek significance determinations 
from OIRA for guidance documents, as appropriate, according to E.O. 
12866 and E.O. 13891.
    One commenter stated that if the Guidance Portal and the procedures 
within this rule are used to revoke guidance that has not been formally 
replaced, it could end up creating more confusion for regulated 
entities and stakeholders rather than helping to resolve it.
    The EPA disagrees that the implementation of this rulemaking will 
cause confusion. In fact, this rulemaking will increase transparency 
regarding the issuance, modification, and rescission of guidance 
documents and benefit regulated entities and stakeholders by clarifying 
which guidance documents are active and in effect. If the EPA rescinds 
a guidance document that clarifies existing obligations, EPA will not 
utilize an alternative policy or interpretation in taking an action 
without providing sufficient and fair notice.

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

    The EPA proposed additional requirements for significant guidance 
documents beyond the requirements for all guidance documents described 
in section III.C. of this preamble. These proposed requirements for 
significant guidance documents included announcements in the Federal 
Register, minimum 30-day comment period, response to comments, approval 
by Presidential appointees, review by OIRA under Executive Order 12866 
before issuance, and compliance with other Executive Orders.
    The EPA received several comments on these proposed requirements 
for significant guidance documents. Most commenters were supportive of 
the requirements to announce new, modified, and rescinded significant 
guidance documents in the Federal Register and to provide the public an 
opportunity to comment. For example, some commenters noted that these 
requirements would increase transparency and public participation that 
may not have occurred when the EPA previously issued significant 
guidance. Some commenters favored other mechanisms to announce 
significant guidance documents instead of or in addition to a Federal 
Register notice (e.g., using the EPA Guidance Portal, through program 
specific websites, notifications to states directly, notifications to 
the affected regulated community through trade associations).
    Most commenters supported the 30-day comment period requirement for 
significant guidance documents. Some commenters recommended that the 
final rule clarify that the 30-day comment period is a minimum and that 
the EPA retains discretion to allow longer comment periods, while other 
commenters recommended that a 60-day comment period should be the 
minimum. Some commenters recommended additional engagement with states 
on a government-to-government basis, beyond the public comment process. 
One commenter recommended that the EPA make the comments received on 
guidance documents publicly available. Some commenters recommended that 
the EPA limit its response to comments on draft guidance to ``major 
concerns'' only (as specified in E.O. 13891, section 4(a)(iii)(A)) and 
recommended that the responses generally inform the public of the 
Agency's thinking on key issues rather than create a detailed record.
    The EPA agrees that the notice and comment requirements for 
significant guidance documents would increase transparency and public 
participation. As stated in the proposal preamble, the EPA reiterates 
that the 30-day public comment opportunity for significant guidance 
documents is a minimum, and the EPA retains discretion to use longer 
comment periods and will do so when it is warranted by the 
circumstances surrounding the issuance of a specific guidance document. 
As stated in the proposal preamble, 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's Bulletin for Agency Good Guidance Practices 
(2007).\12\ The 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.
---------------------------------------------------------------------------

    \12\ Office of Management and Budget. 2007. Final Bulletin for 
Agency Good Guidance Practices (72 FR 3432, January 25, 2007). While 
E.O. 13891 and the OMB Implementation Memorandum (M-20-02) issued on 
October 31, 2019 (the 2019 Memo) supersede the 2007 Bulletin, it is 
``noted that many of the practices specified by E.O. 13891 and 
explained in the 2019 Memo are identical to practices discussed in 
the 2007 Bulletin.'' (Q3 from the 2019 Memo).
---------------------------------------------------------------------------

    Many commenters supported the proposed exceptions to the comment 
requirement for significant guidance documents for ``good cause'' 
because there are emergencies when it is essential for the EPA to be 
able to issue guidance quickly. However, other commenters claimed that 
the proposed exceptions were vague and not transparent.
    The EPA agrees that there can be instances when it is in the public 
interest for the Agency to issue a significant guidance document 
without a public comment period, though such instances are expected to 
be rare. This good cause exception is consistent with E.O. 13891 
(Section 4 (a)) and the APA requirement for regulations (5 U.S.C. 
553(b)(3)(B)). After consideration of the public comments, the EPA is 
finalizing the 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

[[Page 66236]]

non-delegable basis, consistent with E.O. 13891.

E. Procedures for Public To Petition for Modification or Withdrawal (40 
CFR 2.507)

    Consistent with E.O. 13891, the EPA proposed 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 
proposed formatting and content elements for petitions to enable a full 
evaluation by the Agency 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. The EPA would respond to petitions 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 would only 
extend the response date one time for a period not to exceed 90 
calendar days before providing a response. The 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.
    The EPA received comments on the process for requesting 
modification or withdrawal of guidance documents. Several commenters 
supported the creation of petition process and noted that petitions can 
help the Agency be made aware of existing guidance that is of concern 
to impacted stakeholders. Many commenters were supportive of the 
minimum information to be included in petitions and noted that they had 
no suggestions for additional information to be included in petitions 
to modify or withdraw an active guidance document.
    The EPA agrees with these supportive comments. After consideration 
of public comments, the EPA is finalizing 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 EPA is finalizing 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.
    The EPA received public comments requesting more transparency 
surrounding petitions submitted to the Agency. Several commenters noted 
that the EPA should make petitions received publicly available and some 
supported making public the Agency's response to petitions. Commenters 
also believed that the most appropriate place to identify information 
related to petitions is on the EPA Guidance Portal. One commenter 
suggested that the EPA publicize and provide a comment period to allow 
stakeholders and members of the public to comment on such a petition. 
Finally, a commenter noted that the EPA did not indicate how the Agency 
would notify the public of subsequent actions taken by the Agency 
pursuant to the petition.
    The EPA agrees with public comments requesting additional 
transparency regarding petitions received. Therefore, the EPA is 
finalizing a requirement that the Agency make available to the public, 
information about petitions received, including the title of the 
putative guidance document to which the petition pertains. Please note, 
the information about petitions received may, from time to time, 
include references to invalid petitions (such as petitions that do not 
request that the Agency modify or rescind an active guidance document 
or reinstate a rescinded guidance document), and references to such 
invalid petitions is not an acknowledgement by the EPA that the 
documents referenced by those petitions are guidance documents as 
defined by these procedures.
    Although the EPA is not finalizing a requirement for Agency 
responses to petitions to be made publicly available in this 
regulation, the EPA will evaluate the feasibility of doing so in the 
future once more information exists about the volume and complexity of 
petitions. The EPA disagrees with requiring the Agency to seek public 
comment on petitions received because such a process goes beyond E.O. 
13891, would unduly complicate the petition process, and would be 
excessively burdensome for the Agency to implement. The additional time 
required for notice and comment on petitions received could delay the 
timeliness of the Agency's response to petitions. The public will have 
access to information regarding subsequent actions related to a 
petition to modify or withdraw a guidance document through the EPA 
Guidance Portal where the EPA will post newly modified guidance 
documents and remove rescinded guidance documents from the list of 
active guidance documents.
    A few commenters noted that proposed section 2.507 does not contain 
procedures for the public to petition the EPA to add to the EPA 
Guidance Portal a guidance document that a stakeholder believes should 
be an active guidance document. Commenters requested that the EPA add a 
specific procedure by which any party can petition for the inclusion of 
an existing guidance document in the EPA Guidance Portal. One commenter 
stated that if the EPA declines to add a document to the Guidance 
Portal, then the EPA should be required to explain the basis for their 
decision.
    The EPA agrees with these 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 the EPA for reinstatement of a 
rescinded guidance document. The 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. The EPA anticipates that a petition response would 
provide the basis for granting or denying the petition. Prior to 
petitioning the EPA to reinstate a rescinded guidance document, to 
determine the status of a guidance document excluded from the EPA 
Guidance Portal, the public is encouraged to contact the EPA program 
office or regional office that issued the guidance document.
    EPA also received comments regarding the applicability of the 
petition procedures. Specifically, one commenter noted that the scope 
specified in section 2.503(b) of the proposed rulemaking was 
inconsistent with the proposed petition procedures for modification or 
withdrawal of a guidance document. The proposed regulation would limit 
the applicability of the guidance procedures to ``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].'' The commenter noted that limiting the

[[Page 66237]]

applicability of the regulations to guidance documents ``issued after'' 
the proposed rulemaking was inconsistent with the petition procedures 
that apply to all active guidance documents on the EPA Guidance Portal, 
including those issued prior to the effective date of this regulation.
    The EPA agrees that the petition process is intended to apply to 
all active guidance documents and has clarified the applicability in 
this final regulation. In response to comments, the 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.

F. Deviation From Procedures (Proposed 40 CFR 2.502(f))

    The EPA proposed to allow the Agency to deviate from the procedures 
set forth in this regulation when necessary at the written direction of 
the Administrator and in the Administrator's sole and unreviewable 
discretion.
    Several commenters expressed concerns regarding the proposed 
provision that would allow the EPA to deviate from the required 
procedures. These 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.
    The EPA agrees with commenters that this provision creates 
uncertainty and is not finalizing this provision.

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 exempt from review by the Office of Management and 
Budget (OMB) because it is a rule of agency procedure and practice and 
is limited to agency management.

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

    This action is not an Executive Order 13771 regulatory action 
because this action is not significant under Executive Order 12866.

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 13045 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. This regulatory action is a 
procedural rule and does not have any impact on human health or the 
environment.

L. Congressional Review Act

    This rule is exempt from the CRA because it is a rule of agency 
organization, procedure or practice that does not substantially affect 
the rights or obligations of non-agency parties.

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 amends 40 CFR part 2 as follows:

PART 2--PUBLIC INFORMATION

0
1. The authority citation for part 2 is revised 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; Reorganization Plan No. 3 of 1970, 84 Stat. 
2086 (July 9, 1970).


0
2. Add subpart D, consisting of Sec. Sec.  2.501 through 2.507, 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.

[[Page 66238]]

2.507 Procedures for the public to petition for modification, 
withdrawal, or reinstatement.

    Authority: 5 U.S.C. 552, 552a, 553; 28 U.S.C. 509, 510, 534; 31 
U.S.C. 3717; Reorganization Plan No. 3 of 1970, 84 Stat. 2086 (July 
9, 1970).


Sec.  2.501   General.

    This subpart establishes procedures for the issuance of 
Environmental Protection Agency (EPA) guidance documents consistent 
with 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, withdrawal, or reinstatement of such guidance documents.


Sec.  2.502   Scope.

    (a) The procedures in this subpart apply to guidance documents, as 
defined in Sec.  2.503, excluding those excepted under Section 4(b) of 
Executive Order 13981 or that are not otherwise subject to Executive 
Order 13891 or otherwise excepted by the Administrator of OIRA.
    (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 
EPA after November 18, 2020. The procedures and requirements described 
in Sec.  2.504 regarding public access to active guidance documents and 
Sec.  2.507 regarding the procedures for the public to petition for 
modification or withdrawal shall apply to all active guidance documents 
regardless of when they were issued. The procedures for petitioning for 
reinstatement of a rescinded guidance document apply to all guidance 
documents regardless of when they were issued.
    (c) 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.
    (d) If Executive Order 13891, or any provision thereof, is 
rescinded or superseded, this subpart remains in force.


Sec.  2.503   Definitions.

    For the purposes of this subpart, the following definitions apply:
    Active guidance document means a guidance document or significant 
guidance document in effect that EPA expects to cite, use, or rely 
upon.
    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 not 
intended to have substantial future effect on the behavior of regulated 
parties;
    (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, including legal opinions by 
the Office of General Counsel, not intended to have substantial future 
effect on the behavior of regulated parties;
    (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 in the form of speeches, press releases, or 
similar communications, 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.
    Rescinded guidance document means a document that would otherwise 
meet the definition of a guidance document or significant guidance 
document, but that the EPA may not cite, use, or rely upon except to 
establish historical facts.
    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 66239]]

    (d) Significance determinations. The EPA will seek significance 
determinations from the Office of Information and Regulatory Affairs 
(OIRA) for guidance documents pursuant to E.O. 12866.


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 publicly 
available a draft significant guidance document, including a 
significant guidance document that is being reinstated, or draft 
modification 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 of a significant active guidance document, to 
open the public comment period.
    (b) Withdrawal of a significant guidance document. (1) The EPA will 
seek public comment on the Agency's intent to withdraw a significant 
active guidance document.
    (2) The EPA will publish a notice in the Federal Register 
announcing the Agency's intent to withdraw a significant active 
guidance document to open the public comment period.
    (c) Public comment process. (1) Except as provided in paragraph (d) 
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 significant guidance document or issuance of the 
final modified significant guidance document, or withdrawal of an 
active significant 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 significant guidance document itself or in a companion document.
    (d) 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 significant 
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 significant 
guidance document) that notice and public comment thereon are 
impracticable, unnecessary, or contrary to the public interest.
    (e) Additional notices. The EPA also will publish a notice in the 
Federal Register when it finalizes a significant guidance document, 
reinstates a significant guidance document, or finalizes a modification 
or withdrawal of a significant active guidance document.
    (f) Approval. On a non-delegable basis, 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.
    (g) 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, 
withdrawal, or reinstatement.

    (a) Submission of a petition. (1) The public may submit a petition 
to the EPA for the modification or withdrawal of an active guidance 
document, or reinstatement of a rescinded guidance document.
    (2) In order to be considered a valid petition under this section, 
the petition must address the guidance document in question itself and 
not merely underlying statutory or regulatory text.
    (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,'' ``Petition to Withdraw a Guidance Document,'' or 
``Petition to Reinstate a Guidance Document''
    (d) Petition content. A petition for modification or withdrawal of 
an active guidance document, or a petition for reinstatement of a 
rescinded guidance document, should include the following elements:
    (1) Identification of the specific title the guidance document that 
the petitioner is requesting be modified, withdrawn, or reinstated;
    (2) For petitions to modify or withdraw a guidance document only, 
the EPA unique identifier of the guidance document;
    (3) The nature of the relief sought (i.e., modification, 
withdrawal, or reinstatement);
    (4) An explanation of the interest of the petitioner in the 
requested action (i.e., modification, withdrawal, or reinstatement);
    (5) For petitions to modify or withdraw a guidance document only, 
and only if practicable, specification of the text that the petitioner 
request be modified or withdrawn, and, where possible, suggested text 
for the Agency to consider; and
    (6) A rationale for the requested modification, withdrawal, or 
reinstatement.
    (e) Petitions received. The EPA will make available to the public 
information about petitions received, including the title of the 
guidance document to which the petition pertains.
    (f) 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

[[Page 66240]]

appropriate procedures of the EPA, and any suggestions contained in it 
will be considered at the discretion of the Administrator.
    (g) 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.
    (h) Petition response. The EPA may provide a single response to 
issues raised by duplicative petitions and petitions submitted as part 
of a mass petitioning effort.

[FR Doc. 2020-20519 Filed 10-16-20; 8:45 am]
BILLING CODE 6560-50-P


