2023 Final Clean Water Act Section 401 Water Quality Certification

Improvement Rule
Response to Comments Document

This Response to Comments Document, together with the preamble to the final Clean Water Act Section
401 Water Quality Certification Improvement Rule, presents responses of the U.S. Environmental
Protection Agency (EPA) to the comments received on the proposed rule, 87 FR 35318.

In finalizing the proposed rule, the Agency reviewed and considered approximately 27,000 comments
received on the proposed rulemaking from a broad spectrum of interested parties. Commenters provided a
wide range of feedback on the proposal, including the substantive and procedural aspects of the
certification process, how the proposed rule would impact stakeholders, and the legal basis for the
proposed rule. EPA fully considered these comments and addressed all significant issues raised therein,
including revising the rule to reflect the best interpretation of the text of section 401, provide clarity, and
support an efficient certification process that is consistent with the water quality protection and
cooperative federalism principles central to Clean Water Act section 401.

To prepare this document, the Agency summarized comments by 16 topics and developed responses to
the summarized comments. In this document, the Agency's responses appear in bold text. The responses
presented in this document respond to comments that are not otherwise addressed in the preamble and, in
some instances, supplement the preamble's responses to key issues raised in comments. Some
commenters resubmitted comments from previous rulemakings (i.e., 2019 proposed rule) and/or input in
response to the Agency's Notice of Intention (NOI) to Revise the 2020 Rule. EPA summarized this
previous input and addressed it as necessary in this Response to Comments Document. However, the
Agency notes that some prior input is now out of scope or otherwise not relevant to the current
rulemaking.

Although portions of the preamble to the final rule are paraphrased in this document where useful to add
clarity to responses, the preamble itself is the definitive statement of the Agency's rationale for the final
rule. To the extent a response in this document could be construed as in conflict with the preamble of the
final rule, the language in the final rule preamble and regulatory text controls and should be used for
purposes of understanding the requirements and basis of the final rule.

In many instances, responses presented in this Response to Comments Document include cross-references
to responses on similar or related issues located in the preamble to the final rule, the Economic Analysis
for the Final Rule, and/or other sections of the Response to Comments Document. Accordingly, this
Response to Comments Document, together with the preamble to the final rule, the Economic Analysis
for the Final Rule, and the rest of the administrative record should be considered collectively as EPA's
response to all of the significant comments submitted on the proposed rule.

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Table of Contents

1 When Certification is Required (Section 121.2)	1

1.1	Triggers for CWA section 401	1

1.2	Whether EPA Should Establish a Process to Determine Whether an Activity May Result in a
Discharge	7

1.3	Input Received on Prior Rulemakings	8

2.	Pre-filing Meeting Requests (Section 121.4)	8

2.1	General Comments on the Pre-Filing Meeting Request Requirement	8

2.2	Support Greater Flexibility in Pre-Filing Meeting Request Process	10

2.3	Comments on the Default Timeline	11

2.4	Timing of the Pre-Filing Meeting Request in Relation to the Federal License or Permit Process
12

2.5	Project Proponent Participation in Pre-Filing Meeting Need	13

2.6	Pre-Filing Meeting Requests Procedures	13

2.7	Input Received on Prior Rulemakings	17

3.	Request for Certification (Section 121.5)	18

3.1	Defining the Contents of a Certification Request	18

3.2	Receipt of a Request for Certification	60

3.3	Timing of the Request for Certification	70

3.4	General Comments on Request for Certification	74

3.5	Input Received on Prior Rulemakings	76

4.	Reasonable Period of Time (Section 121.6)	79

4.1	Who Sets the Reasonable Period of Time	79

4.2	Default Reasonable Period of Time	87

4.3	Causes for Delays and Data	101

4.4	Extensions to the "Reasonable Period of Time"	102

4.5	Withdrawal and Resubmittal	106

4.6	Input Received on Prior Rulemakings	113

5.	Scope of Certification (Section 121.3)	117

5.1	Activity Scope of Certification	117

5.2	Water Quality-Related Effects and Requirements	149

5.3	Definition of Water Quality Requirements (W QR)	155

5.4	Scope of Section 401(a) and (d)	162

5.5	Disagree with Scope of Waters	163

5.6	Explicit Input on Preamble Example Conditions	164

5.7	Input Received on Prior Rulemakings	165

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6.	Certification Decisions ( Section 121.7)	172

6.1	What It Means "To Act"	172

6.2	Contents of a Certification Decision	175

6.3	General	179

6.4	Input Received on Prior Rulemakings	184

7.	Federal Agency Review (Sections 121.8-121.9)	187

7.1	Support Proposed Approach to Federal Agency Review (In All Or Part)	187

7.2	Support 2020 Rule Approach to Federal Agency Review	191

7.3	Do Not Support Federal Agency Review at All	193

7.4	Waiver for "Reasonable Period of Time" Passage Only	194

7.5	Demonstrating Compliance with Elements in Proposed Section 121.9	194

7.6	Ability to Remedy Deficiencies	195

7.7	Input Received on Prior Rulemakings	199

8.	EPA's Roles Under Section 401 (Sections 121.16-121.18)	202

8.1	EPA as a Certifying Authority	202

8.2	Lands of Exclusive Federal Jurisdiction	205

8.3	Input Received on Prior Rulemakings	207

9.	Modifications (Section 121.10)	207

9.1	General Legal Comments on Modification	207

9.2	Impact of Modifications	210

9.3	Types of Modifications	214

9.4	When Modifications May Occur	219

9.5	Participants in the Modification Process	222

9.6	General	227

9.7	Input Received on Prior Rulemakings	233

10.	Enforcement and Inspection	235

10.1	Enforcement	235

10.2	Inspection	239

10.3	Input Received on Prior Rulemakings	240

11.	Neighboring Jurisdictions (Sections 121.12-121.15)	242

11.1	General	242

11.2	Initiating the Neighboring Jurisdiction Process	248

11.3	"May Affect" Determination	251

11.4	Neighboring Jurisdiction's Role	259

11.5	Public Hearing	268

11.6	Federal Agency Decision	272

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11.7 Input Received on Prior Rulemakings	273

12.	Treatment in a Similar Manner as a State (TAS) (Section 121.11)	274

12.1	Proposal to Add TAS Provisions for Solely Section 401 and 401(a)(2)	274

12.2	Oklahoma-Specific Concerns	277

12.3	TAS Application Process	278

12.4	Implementation Considerations	280

13.	Implementation	281

13.1	Effective Date	281

13.2	Implementation Challenges and Coordination	283

13.3	Implementation Tools	284

13.4	Input Received in Prior Rulemakings	285

14.	Economic Analysis	286

14.1	Claims Relative to 1971 and 2020 Rules	286

14.2	Data and Evidence	288

14.3	Information Collection Request	289

14.4	Input Received in Prior Rulemakings	290

15.	Rulemaking Process	291

15.1	Rulemaking Process - General	291

15.2	Executive Orders/Statutory Requirements	294

15.3	Input Received in Prior Rulemakings	297

16.	General	300

16.1	General input on the 2020 Rule and 1971 Rule	300

16.2	General input on CWA, Congressional Intent, and Cooperative Federalism	304

16.3	General Input on Infrastructure, Industry, Etc	309

16.4	General input on Biden Administration priorities	312

16.5	General - Other Topics	314

16.6	Input Received in Prior Rulemakings	326

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1

When Certification is Required (Section 121.2)

1.1 Triggers for CWA section 401

1.1.1 Addition of the Phrase "From a Point Source "

Several commenters supported the proposed change to 40 CFR 121.2 to add the phrase "from a point
source." These commenters stated that the change is consistent with applicable case law and the text and
structure of the Clean Water Act (CWA). In addition, these commenters appreciated that EPA clarified
that section 401 was triggered by a discharge from a point source versus a discharge from a nonpoint
source. One of these commenters stated that the rule needs to be explicit that point sources include
discharges from CWA section 404 dredge and fill activities because this added clarification would reduce
unnecessary water quality impacts that occur and are addressed with after-the-fact permits and/or
enforcement actions.

One commenter recommended that the Agency should retain the definition for "discharge" from the 2020
Rule in section 121.1 and incorporate equipment and construction activities associated with the discharge
of dredged or fill material that have an immediate and direct potential water quality impact into the
definition.

On the other hand, other commenters opposed the change to 40 CFR 121.2 that added the phrase "from a
point source." These commenters pointed out that while EPA is not proposing to define "discharge" or
"point source" in the regulations, EPA refers to the definition of point source at 33 U.S.C. § 1362(14)
when discussing the trigger for section 401 certification, which defines "point source" to mean a discrete
conveyance from which "pollutants are or may be discharged." Thus, by adding the phrase "from a point
source," the commenters asserted that EPA is implicitly requiring the addition of a pollutant to trigger 401
certification, which is inconsistent with SI) Warren where the Court concluded that the meaning of
"discharge" in section 401 is broader than "discharge of a pollutant." The commenters stated that the
addition of the phrase "from a point source" creates confusion given that EPA has already recognized that
a discharge does not require the addition of pollutants to trigger section 401 and appears to conflict with
EPA's concurrent proposal that the scope of review is restored to the "activity as a whole." The
commenters recommended that EPA remove the phrase "from a point source" from the final version of 40
CFR 121.2. One commenter asserted that the phrase was unnecessary and could create confusion over
which projects require certification and suggested keeping section 121.2 in line with the statutory
language. Another commenter suggested striking "from a point source" and adding "with or without
pollutants" after discharge. A couple of commenters suggested that if EPA did not strike the phrase "from
a point source," the rule should state that certification is triggered regardless of whether the discharge
from a point source results in an addition of pollutants.

Further, many commenters urged EPA to revise the regulation to include discharges from both point and
nonpoint sources. These commenters stated that the term "discharge" as used throughout the CWA means
something broader than discharges from point sources (citing SI) Warren) given that the goal of the CWA
is to "restore and maintain the chemical, physical and biological integrity of the Nation's waters." See 33
U.S.C. 1251(a). The commenters asserted that revising the regulation to include nonpoint sources will

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ensure that states and Tribes are able to exercise their section 401 authority to protect water quality at
federally licensed or permitted activities that would result in a nonpoint source discharge. One commenter
asserted that not including nonpoint sources ignores the threat that diffuse runoff poses to waterways,
while another commenter stated that nonpoint sources could account for threats that agricultural and
similar runoff pose to waterways. Another commenter stated that the statute says clearly that it applies to
"any applicant for a federal license or permit for" any activity that may result in "any discharge," and
therefore encompasses permitted nonpoint source discharges. Similarly, a different commenter
encouraged the Agency to use the statutory language in section 401(a)(1) to describe the type of activity
that triggers 401 and asserted that limiting discharges to point sources has no basis in the statutory text.
One commenter asserted that the Federal government and the Supreme Court recognized that all
discharges trigger section 401. Another commenter argued that the Agency looked away from Congress's
obvious intent and relied on the Ninth Circuit cases, even though it cannot stand in the place of the
Supreme Court's more expansive definition of "discharge." The commenter suggested that EPA should
add nonpoint sources to the regulatory text, or in the alternative, strike the reference to a point source.
One commenter said that states and Tribes should have the ability to review all federally authorized
activities, which include activities that only involve nonpoint source pollution.

Many commenters supported the change to clarify that a discharge triggering a 401 certification does not
require an addition of pollutants. On the other hand, there were some commenters who stated that the
proposed change goes beyond the plain language of CWA section 401 by eliminating the requirement that
there be an addition of pollutants to trigger the discharge requirement. These commenters stated that the
proposed change would lead to uncertainty and is too broad.

Agency's Response: EPA is finalizing the text at section 121.2, including the phrase "from a
point source," because it is consistent with the case law (as discussed in section IV.A.2 of the
final rule preamble) and the Agency's longstanding approach, and because it provides
greater clarity about the nature of discharges that trigger the need for section 401
certification or waiver. However, just as the Agency is not defining in regulation the term
"discharge" for purposes of section 401, the Agency is not providing a distinct definition of
the term "point source." Rather, the Agency will continue to rely on the definition of "point
source" in section 502(14) of the CWA. For example, courts have concluded that
bulldozers, mechanized land clearing machinery, and similar types of equipment used for
discharging dredge or fill material are "point sources" for purposes of the CWA. See, e.g.,
Avoyelles Sportsmen's League v. Marsh, 715 F.2d 897 (5th Cir. 1983); United States v.
Larkins, 657 F. Supp. 76 (W.D. Ky. 1987), aff'd, 852 F.2d 189 (6th Cir. 1988). On the other
hand, courts have concluded that a water withdrawal is not a point source discharge and
therefore does not require a water quality certification. See, e.g., North Carolina v. FERC,
112 F.3d 1175,1187 (D.C. Cir. 1997) (holding that withdrawal of water from lake does not
constitute discharge for CWA section 401 purposes).

Although the Agency is retaining the same interpretation of "discharge" as the 2020 Rule,
to simplify the regulation, the Agency is removing the definition of "discharge" and instead
incorporating those definitional concepts into the regulatory text at final rule section 121.2,
which discusses when certification is required. This simpler approach will provide greater

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clarity about the nature of discharges that trigger the need for section 401 certification or
waiver.

EPA disagrees with commenters asserting that the definition of "point source" located at 33
U.S.C. 1362(14) implicitly requires the addition of pollutants. The CWA provides that a
point source is a conveyance "from which pollutants are or may be discharged." 33 U.S.C.
1362(14). Given the language of the statute, it is reasonable for EPA to conclude that a
discharge of pollutants is not required for a conveyance to be considered a point source.
The Agency also disagrees that the requirement of a point source discharge to trigger
section 401 conflicts with the scope of review. As discussed in section IV.E of the final rule
preamble, once there is a prerequisite potential for a point source discharge into waters of
the United States, then the certifying authority may evaluate and place conditions on the
"activity," which includes consideration of water quality-related impacts from both point
sources and nonpoint sources. EPA appreciates commenter suggestions regarding
regulatory text that states that a point source does not need to result in an addition of
pollutants. EPA is declining to add such language in the regulatory text and instead relying
on the statutory definition of "point source." However, EPA has emphasized this point
throughout section IV.A of the final rule preamble and will continue to do so in
implementation of the final rule.

The Agency disagrees that the term "discharge" as used in CWA section 401 means
something broader than discharges from point sources or that it has no basis in the
statutory text. As discussed in section IV.A.2 of the final rule preamble, the ONDA court
held that the "term 'discharge' in [section 401] is limited to discharges from point sources."
Or. Natural Desert Ass'n (ONDA) v. Dombeck, 172 F.3d 1092,1097 (9th Cir. 1998). EPA also
disagrees that the Federal government has recognized that all discharges trigger section
401. This was the Federal government's position before the Ninth Circuit in ONDA, and
EPA has consistently implemented this view in rulemaking, guidance, and through its
actions pursuant to CWA section 401. EPA emphasizes that this final rule does not prevent
or limit certifying authorities from protecting their water quality from federally licensed or
permitted activities that would result in nonpoint source discharges. See 33 U.S.C. 1370.
With respect to using section 401 certifications to address nonpoint source discharges,
certifying authorities may consider water quality-related impacts from nonpoint source
discharges after determining that the project satisfies the prerequisite potential for a point
source discharge into waters of the United States.

EPA strongly disagrees that the plain language of section 401 requires that any discharge
triggering section 401 include an addition of pollutants. The CWA provides that "[t]he term
'discharge' when used without qualification includes a discharge of a pollutant, and a
discharge of pollutants." 33 U.S.C. 1362(16). The CWA defines "discharge of a pollutant" to
mean "any addition of any pollutant to navigable waters from any point source." Id. at

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1362(12).1 EPA and the Corps have long interpreted the definition of "discharge" in way
that gives meaning to the word "includes" in the definition. EPA and the Corps have
interpreted the definition of "discharge" to be distinct from the term "discharge of
pollutant" and therefore encompassing both the discharge without the addition of
pollutants and the "discharges of pollutants." Additionally, as discussed in section IV.A.2 of
the final rule preamble, this interpretation is consistent with the text of the statute as
interpreted by the U.S. Supreme Court. The Agency also observes that the final rule's
interpretation of discharge is not a change from longstanding practice, including the 2020
Rule. See 85 FR 42237 ("The EPA has concluded that unlike other CWA regulatory
provisions, section 401 is triggered by the potential for any unqualified discharge, rather
than by a discharge of pollutants.").

1.1.2	Potential to Discharge

Most commenters supported the proposed rule preamble's clarification that section 401 is triggered by a
discharge as well as a potential to discharge. Conversely, a few commenters, seeming to refer to the
proposal preamble as opposed to regulatory text, expressed concern that the addition of the word
"potential" will change the universe of projects requiring 401 certification.

Agency's Response: EPA disagrees with commenters asserting that section 401 is not
triggered by the potential to discharge. The phrase "may result" contemplates that both the
presence of, and/or potential for, any discharge triggers the requirement for a section 401
certification. EPA's approach is consistent with the plain language of the statutory phrase
"may result in any discharge." This approach is also consistent with the Agency's
longstanding implementation of section 401. See, e.g., 85 FR 42236 ("Under this final rule,
the requirement for a section 401 certification is triggered based on the potential for any
federally licensed or permitted activity to result in a discharge from a point source into
waters of the United States."); 2010 Handbook at 4 (rescinded in 2019) ("It is important to
note that [section] 401 is triggered by the potential for a discharge; an actual discharge is
not required.").

1.1.3	"License or Permit" the Potential to Discharge

Some commenters expressed support for the clarification in the proposed rule preamble that section 401 is
not triggered by state or Tribal licenses or permits because it helps to ensure that project proponents do
not go through unnecessary permitting processes beyond the scope of the CWA.

Several commenters requested clarification that the section 401 certification process only applies to
individual Federal licenses or permits. These commenters requested that EPA affirmatively state that the
section 401 certification process does not apply to verifications of Federal general permit actions; instead,

1 The CWA, including section 401, uses the term "navigable waters," which the statute defines as "the
waters of the United States, including the territorial seas." 33 U.S.C. 1362(7). This final rule uses the term
"waters of the United States" interchangeably with "navigable waters".

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the certification process should occur at the time the Federal general permit is issued. Another commenter
said that it is not clear how the proposed rule would apply to nationwide permits (NWPs) and state
programmatic permits, and further suggested that these water quality certifications be exempted from the
proposed rule.

At least one commenter supported EPA's decision not to explicitly list Federal authorizations that trigger
section 401 certification.

Agency's Response: The CWA is clear that the license or permit prompting the need for a
section 401 certification must be a Federal license or permit, that is, one issued by a Federal
agency. As discussed in section IV.A.2 of the final rule preamble, Section 401 certification is
not required for licenses or permits issued by a state or Tribe that administers a federally
approved permit program (e.g., section 402 National Pollutant Discharge Elimination
System (NPDES) permitting program or the section 404 dredge and fill permitting
program). Permits issued by states or Tribes pursuant to their authorized or approved
program are not subject to section 401 of the CWA as the programs operate in lieu of the
Federal program, under state or Tribal authorities. The state or Tribal permit is not a
"Federal" permit for purposes of section 401.

EPA disagrees with commenters asserting that the section 401 certification process only
applies to individual Federal licenses or permits, or that general permits, such as NWPs,
could be exempted from section 401 and this final rule. Section 401 is not limited to
individual Federal licenses or permits, but also extends to general Federal licenses and
permits such as CWA section 404 general permits (including Nationwide General Permits,
Regional General Permits, and State Programmatic General Permits) and CWA section 402
general permits (including the Pesticide General Permit, Multi-Sector General Permit for
stormwater discharges associated with industrial activity, and the Construction General
Permit for stormwater discharges associated with construction activity). General Federal
licenses or permits that may result in a discharge into waters of the United States are
subject to the same requirements under section 401 as an individual Federal license or
permit. Section 401 does not provide an exemption for any Federal licenses or permits that
may result in a discharge into waters of the United States. Additionally, both case law and
prior Agency rulemakings and guidance recognize that general Federal licenses or permits
are subject to section 401 certification. See U.S. v. Marathon Development Corp., 867 F.2d
96,100 (1st Cir. 1989) ("Neither the language nor history of section 404(e) of the Clean
Water Act... suggests that states have any less authority in respect to general permits than
they have in respect to individual permits."); 40 CFR 121.5(c), 121.7(d)(2), 121.7(e)(2)
(2020) (describing requirements for certification on the issuance of a general license or
permit); 2010 Handbook at 29-30 (rescinded in 2019) (discussing the application of section
401 to general permits). Accordingly, EPA cannot adopt commenter suggestions to exempt
general permits from the certification process.

Federal agencies must seek certification on general permits before the permits are issued. In
response to commenters suggesting that the certification process should occur at the time

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the Federal general permit is issued, final rule section 121.5 provides the minimum content
requirements for all requests for certification, including certification for the issuance of a
general Federal license or permit. If a certifying authority grants or waives certification for
either a CWA section 402 or 404 general permit, then entities seeking coverage under that
general permit do not need to separately seek certification before doing so. When a
certifying authority denies certification on a section 402 general permit, EPA can issue the
general permit for the jurisdictions that granted or waived certification but cannot issue the
permit for jurisdictions that denied certification. If a certifying authority grants
certification with conditions on an EPA-issued general permit, then the certification with
conditions becomes part of the general permit applicable within the certifying authority's
jurisdiction. When a certifying authority denies certification for a CWA section 404
Nationwide or Regional General Permit, the Corps allows specific projects to be covered by
the Nationwide or Regional General Permit if the project proponent obtains certification
from the certifying authority for that project. In that instance, a project proponent would
submit a request for certification in accordance with final rule section 121.5 for individual
Federal licenses or permits. When a certifying authority grants certification with conditions
on a Nationwide or Regional General Permit, the Corps may either incorporate the
conditions into a state- or Tribe-specific version of the general permit or require the project
proponent to obtain certification from the certifying authority for that project to qualify for
the general permit.

The Agency is not providing an exclusive list of Federal licenses and permits that may be
subject to section 401. The CWA itself does not list specific Federal licenses and permits
that are subject to section 401 certification requirements. Although the Agency is not
providing an exclusive list of all Federal licenses or permits subject to section 401, EPA
recognizes that there is an array of licenses and permits that may trigger the need to seek
certification. See section IV.A.3 of the final rule preamble for further discussion on the
types of Federal licenses or permits subject to section 401.

1.1.4 Other Comments Related to 40 CFR 121.2

One commenter voiced support for EPA clarifying in the proposed rule's preamble that withdrawals from

navigable waters are not discharges and therefore do not trigger Section 401, including citing court

precedent from North Carolina v. FERC, 112 F.3d 1175, 1187 (D.C. Cir. 1997). This commenter wrote

that EPA should include that clarification in the final regulatory text of the final rule.

Agency's Response: As discussed in section IV.A.2 of the final rule preamble, courts have
concluded that a water withdrawal is not a point source discharge and therefore does not
require a water quality certification. However, as explained above, the Agency is not
providing a distinct definition of the term "point source" or actions that do not qualify as
point sources. Rather, the Agency will continue to rely on the definition of "point source" in
section 502(14) of the CWA.

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1.2 Whether EPA Should Establish a Process to Determine Whether an Activity May
Result in a Discharge

Some commenters asserted that EPA should develop a process for determining when a federally licensed
or permitted activity may result in a discharge and require section 401 certification. One commenter
stated that such a process would allow for consistent implementation of section 401. Another commenter
asserted that a clear process is necessary because the proposed rule would significantly increase the
number of projects requesting certification. A few of these commenters recommended specific procedures
for determining when an activity requires a section 401 certification. One commenter suggested a
minimum three-step process as follows: first, the project proponent must contact the Federal agency;
second, the Federal agency must determine whether the point source discharge will impact a water of the
United States and require a Federal license or permit, and determine whether a section 401 certification
has been categorically granted by the certifying authority; third, if the Federal agency determines that the
certifying authority did not categorically certify the activity, then the project proponent must request
certification from the certifying authority. Another commenter suggested that any procedures should
explicitly exclude unanticipated impacts to waters of the United States and projects that do not directly
discharge into a water of the United States and implement best management practices for minimizing a
discharge of pollutants into waters of the United States. The same commenter asserted that the proposed
rule did not clearly state how a project proponent can determine whether a project may result in a
discharge into a water of the United States and classify or quantify unanticipated impacts. The commenter
further argued that the use of the term "may" is problematic when considering the probability of a project
to discharge into a water of the United States and asserted that project proponents will have difficulty
estimating impacts that are not accounted for in project planning and design and will submit incomplete
or inadequate information to the certifying authority, ultimately delaying issuance of a certification.

One commenter recommended developing regulatory text that would allow, but not require, the relevant
certifying authority, Federal agency, and EPA Regional Administrator to develop a process for
determining when section 401 certification is required. Another commenter stated that the Agency should
provide a public notice and comment opportunity on any procedure to determine when certification is
required.

A few commenters suggested that EPA should develop a guidance document for project proponents that
clarifies when a federally licensed or permitted activity may result in a discharge.

Some commenters asserted that EPA should not develop a process for determining when a federally
licensed or permitting activity may result in a discharge and require section 401 certification. These
commenters argued that certifying authorities and/or Federal agencies have well-established practices and
experience determining whether an activity will require a section 401 certification, including one
commenter who asserted that an EPA-defined process could disrupt established efficiencies.

Agency's Response: Based on comments, the Agency is not developing a specific process or
procedure for project proponents, certifying authorities, and/or Federal agencies to follow
to determine whether a federally licensed or permitted activity may result in a discharge
and therefore require section 401 certification. After more than 50 years of implementing

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section 401, EPA's experience is that Federal agencies and certifying authorities are well-
versed in the practice of determining which Federally licensed or permitted projects may
result in discharges. Ultimately, the project proponent is responsible for obtaining all
necessary permits and authorizations, including a section 401 certification. If there is a
potential for a project to discharge into "waters of the United States," a Federal agency
cannot issue the Federal license or permit unless a section 401 certification is granted or
waived by the certifying authority. EPA recommends that project proponents engage in
early discussions with certifying authorities and Federal agencies to determine whether
their federally licensed or permitted activity will require section 401 certification.

1.3 Input Received on Prior Rulemakings

1.3.1 Pre-proposal Input from 2021

This sub-topic summarizes input that was received prior to the 2022 proposed rule and was resubmitted
by commenters in the docket for the 2022 proposed rule.

One stakeholder asserted that the 2020 Rule illegally defined the term "discharge" to mean a "discharge
of pollutants" and that such an interpretation had already been rejected by the Supreme Court.

One stakeholder requested that EPA should clarify that withdrawals from navigable waters do not trigger
the section 401 process, nor are they discharges whose impacts may be addressed by certification
conditions. The stakeholder requested that EPA clarify that this remains the Agency's position, citing the
2020 Rule.

Agency's Response: See the Agency's Response to Comments in Section 1.1.1; see also
Section IV.A of the final rule preamble.

2. Pre-filing Meeting Requests (Section 121.4)

2.1 General Comments on the Pre-Filing Meeting Request Requirement

Almost all commenters that addressed the proposed pre-filing meeting request requirement acknowledged
that pre-filing meetings can be a tool for certifying authorities and project proponents to discuss details
and the information needed before the request for certification is submitted. Several commenters
recognized the value of pre-filing meetings in the case of large or complex projects. Multiple commenters
said pre-filing meetings have the potential to streamline the certification process by facilitating early
coordination. One commenter noted that being able to allocate resources to priority projects in states like
Michigan and New York, which receive 5,000 and 4,000 certification requests per year, respectively, will
be critical, while also noting that pre-filing meetings will allow project proponents to receive critical
information from the certifying authority (i.e., information needed for a complete request, time for
review, water quality impacts the certifying authority wants addressed).

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Some commenters expressed concern about the proposed approach and stated that the pre-filing meeting
request requirement was unnecessary. These commenters said that the proposed approach would add
process without substantive benefit and create unnecessary delays and administrative burden. Another
commenter outlined an example of their concerns with delays and administrative challenges. One
commenter questioned whether there had been sufficient experience with pre-filing meeting request
requirement, given that the requirement has been in effect for a short period of time.

Most of the commenters addressing alternative approaches for the pre-filing meeting request provisions
recommended not having a requirement. Instead, the commenters said EPA should encourage early
coordination but keep the pre-filing meeting request optional to avoid delays and not strain resources. One
commenter suggested that the pre-filing meeting request requirement should be discretionary.

A couple of commenters suggested renaming "pre-filing meeting request" as "pre-filing project
notification" to characterize the submittal more appropriately.

Agency's Response: EPA disagrees with commenters asserting that the final rule's
approach to pre-filing meeting requests would not provide substantive benefit or create
unnecessary delays. Rather, EPA agrees with commenters who acknowledged the utility
and value of the pre-filing meeting, including the potential to streamline the certification
process. EPA encourages certifying authorities to make their requests for certification
requirements and the applicable submission procedures transparent to project proponents,
especially in instances where the pre-filing meeting request requirement was waived, so that
submission of the request for certification goes smoothly in cases where there is no early
coordination through the pre-filing meeting process.

The Agency also disagrees with commenters suggesting that the Agency should remove the
pre-filing meeting provision or make it optional. EPA finds that the final rule's approach to
the pre-filing meeting request requirement both facilitates early coordination in the
certification process while recognizing that states and Tribes are in the best position to
determine whether a particular project (or class of projects) would benefit from such early
coordination. Accordingly, this final rule enables a certifying authority to shorten or waive
the pre-filing meeting request requirement on a case-by-case or categorical basis. For
example, certifying authorities may categorically waive or shorten the pre-filing meeting
request requirement for less complex, routine projects, as these projects most likely would
not benefit from early engagement between the project proponent and certifying authority
as large, complex projects would. This flexibility reflects both cooperative federalism
principles and the reality that not every project will meaningfully benefit from a pre-filing
meeting.

The Agency finds that there has been sufficient experience with the pre-filing meeting
request requirement. As discussed in section IV.B.2 of the final rule preamble, the pre-filing
meeting request provision was introduced in the 2020 Rule. The final rule's approach to the
pre-filing meeting request process best reflects both the Agency's 2 years of experience
implementing this provision, as well as public input.

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EPA appreciates commenter suggestions to rename "pre-filing meeting request" as "pre-
filing project notification." However, the Agency finds the term "pre-filing meeting
request" to be a more accurate characterization of the submittal from a project proponent
to a certifying authority. Section 121.4 requires a project proponent to "request a pre-filing
meeting with the certifying authority" and not merely notify the certifying authority of its
intention to submit a request for certification. Accordingly, EPA is retaining the phrase
"pre-filing meeting request" in section 121.4.

2.2 Support Greater Flexibility in Pre-Filing Meeting Request Process

Many commenters supported the proposed approach to allowing certifying authorities to waive the pre-
filing meeting request requirement or shorten the time between requesting a pre-filing meeting and
requesting certification. These commenters noted that it would allow certifying authorities to speed up
certification decisions.

Some commenters stated that certifying authorities should have the flexibility to decide whether pre-filing
meeting requests are needed based on project complexity and to efficiently utilize their time and
resources. One commenter who supported the proposed approach to the pre-filing meeting requirement
noted that it receives over 1,600 401 certification applications per year and that the 2020 Rule's approach
to pre-filing meeting requests created unnecessary delays for certain projects. Several commenters stated
that the proposed provision is reasonable and will streamline the certification process, especially with
respect to simpler projects. One commenter observed that it will increase early stakeholder engagement
and allow certifying authorities to anticipate and plan for future workload to act once a certification
request is received. Another commenter noted that discretionary pre-filing meetings would promote
efficiency and adaptability within the certification process, may avoid delays when a project requires
emergency authorization, and would reduce the administrative burden on the certifying authority and
project proponent when a proposed project would have minor impacts to aquatic resources. Another
commenter stated that for those projects that benefit from a pre-filing meeting, questions and concerns
regarding the project can often be adequately addressed during the meeting and the project proponent can
submit the certification request shortly after the meeting.

A couple of commenters recommended that EPA should make clear that certifying authorities may waive
the proposed pre-filing meeting request requirement for all projects. One commenter suggested the rule
should enable certifying authorities to issue blanket waivers of the pre-filing meeting request, with the
option to reinstate the requirement on a case-by-case basis.

Agency's Response: The Agency agrees with commenters that certifying authorities should
have the flexibility to decide whether pre-filing meeting requests are needed. Accordingly,
this final rule provides certifying authorities with the flexibility to waive or shorten the
requirement on a case-by-case or categorical basis. For example, certifying authorities
could either require or waive the pre-filing meeting request requirement for all projects,
specific types of projects (e.g., projects under 300 linear feet), or types of Federal licenses or
permits (e.g., general permits). EPA recommends that certifying authorities clearly

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communicate to project proponents their expectations for pre-filing meetings requests and
waivers (e.g., whether they may grant waivers, either categorically or on an individual
basis, and any procedures and/or deadlines for submission of requests and the grant of
waivers) so that project proponents may clearly and efficiently engage in the certification
process. EPA also recommends that certifying authorities make this information readily
available to project proponents in an easily accessible manner to allow for a transparent
and efficient process (e.g., posting a list of project types that require a pre-filing meeting
request on the certifying authority's website).

2.3 Comments on the Default Timeline

A few commenters supported retaining the default 30-day time period between the pre-filing meeting
request and request for certification. One commenter said that if the pre-filing meeting requirement is not
waived by the certifying authority, the maximum (not minimum) period between the written request for a
pre-filing meeting and the time for filing the certification request should not exceed 30 days. One
commenter stated that they would prefer if certifying authorities set timelines or defaults to timelines
between requesting a pre-filing meeting and requesting certification in regulation but noted that if EPA
retained the pre-filing meeting request requirement, the 30-day timeline is an acceptable minimum
timeline between the submission of a pre-filing meeting request and certification request. However, the
same commenter asserted that EPA should allow certifying authorities to adjust the timelines where
needed (e.g., for urgent or emergency actions) or waive the need for a pre-filing meeting request based on
permit type.

Several commenters recommended either reducing the 30-day default time period between the pre-filing
meeting request and certification request or removed entirely. One commenter asserted that the proposed
rule's 30-day wait time between the pre-filing meeting request and certification request could extend the
project schedule by a few weeks or months. A different commenter suggested reducing the default time
period to 15 days or upon notification by the certifying authority that they do not require a pre-filing
meeting. Another commenter supported shortening the default time period to avoid lengthening the
certification process without any benefit to the Federal agency or the project proponent. The same
commenter asserted that projects should not need to wait 30 days if it qualifies as a critical project (e.g.,
project needed to maintain grid reliability and resiliency). Another commenter recommended removing
the 30-day pre-filing meeting request requirement and argued that it is unnecessary for smaller projects,
added more time and workload for states, confused applicants, and delayed certification application
submissions.

Agency's Response: This final rule enables a certifying authority to shorten or waive the
pre-filing meeting request requirement on a case-by-case or categorical basis. If a certifying
authority does not communicate whether it wants to waive or shorten the pre-filing meeting
request requirement, the Agency agrees with commenters that the project proponent must
wait 30 days from requesting a pre-filing meeting to submit its request for certification.

The Agency does not find it necessary to shorten the default time frame between requesting
a pre-filing meeting and requesting certification, because the final rule enables certifying

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authorities to waive or shorten the pre-filing meeting request requirement. EPA finds that
the final rule's approach to the pre-filing meeting request requirement both facilitates early
coordination in the certification process while recognizing that states and Tribes are in the
best position to determine whether a particular project (or class of projects) would benefit
from such early coordination. In the event the certifying authority does not communicate
whether it wants to waive or shorten the timeframe, the final rule provides a known
backstop to stakeholders since the 30-day wait period existed under the 2020 Rule.

The Agency also disagrees with commenters asserting that there is no benefit of the pre-
filing meeting request process; see the Agency's response to comments in section 2.1.

2.4 Timing of the Pre-Filing Meeting Request in Relation to the Federal License or
Permit Process

A few commenters provided input on the timing of the pre-filing meeting request in relation to the
Federal licensing or permitting process. One commenter suggested that EPA should clarify that the pre-
filing meeting request process should occur after the Federal agency determines whether the activity is
covered by an existing certification. The commenter stated that under the 2020 Rule, project proponents
request pre-filing meetings before providing the permit that the project will be issued under, and thus
coverage under an existing certification is unknown. In cases where the Corps later determines the
activity is covered under a certified NWP, the commenter stated that it expends scarce time and resources
on pre-filing meetings and requests for certification that prove to be unnecessary. Another commenter
asserted that limiting pre-filing meetings until after the Federal agency has drafted the Federal license or
permit may reduce coordination between states and Federal agencies. As a result, the commenter asserted
that states would not be engaged until the end of the Federal license or permit process rather than at the
beginning and throughout the process.

Agency's Response: As discussed in section IV.C of the final rule preamble, if the request
for certification is for an individual Federal license or permit, the request for certification
must include a copy of the Federal license or permit application and any readily available
water quality-related materials that informed the development of the application. If the
request for certification is for the issuance of a general Federal license or permit, then the
request for certification must include a copy of the draft Federal license or permit and any
readily available water quality-related materials that informed the development of the draft
Federal license or permit. Accordingly, a project proponent may not request a pre-filing
meeting until it has provided the Federal license or permit application to the Federal agency
(for an individual license or permit) or until the Federal agency has developed the draft
license or permit (for the issuance of a general license or permit). However, nothing in this
final rule prevents certifying authorities, project proponents, and Federal agencies from
coordinating and engaging prior to the pre-filing meeting request process or during the
certification process as a whole.

Although the final rule provides a bright line for the earliest point in time that a project
proponent may request a pre-filing meeting, EPA declines to define when a project

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proponent must submit a pre-filing meeting request. However, EPA recommends that
certifying authorities clearly communicate to project proponents their expectations for pre-
filing meetings requests and waivers (e.g., whether they may grant waivers, either
categorically or on an individual basis, and any procedures and/or deadlines for submission
of requests and the grant of waivers) so that project proponents may clearly and efficiently
engage in the certification process. EPA also recommends that certifying authorities make
this information readily available to project proponents in an easily accessible manner to
allow for a transparent and efficient process (e.g., posting a list of project types that require
a pre-filing meeting request on the certifying authority's website).

2.5	Project Proponent Participation in Pre-Filing Meeting Need

Some commenters expressed support for the project proponent participating in determining the need for a
pre-filing meeting. These commenters suggested that project proponents are most familiar with the
complexity of project and in most cases know when early coordination is necessary. Some of the
commenters also stated that project proponent participation would help minor projects that do not require
additional coordination to move more quickly through the certification process and avoid unnecessary
delays. A commenter expressed support for the alternative approach of allowing a project proponent to
request a waiver of the pre-filing meeting and the certifying authority to grant a waiver or the meeting.
There were also commenters who said the Federal agency and the project proponents should be involved
in determining the need for a pre-filing meeting.

Several commenters opposed project proponent participation in the pre-filing meeting process and
asserted that the certifying authority should maintain sole discretion on whether to shorten or waive the
pre-filing meeting request. One commenter suggested that allowing project proponents any authority in
determining the need for a pre-filing meeting would diminish the authority of states and Tribes under
Section 401.

Agency's Response: After considering public comments, EPA is not requiring the
participation of the project proponent when determining the need for a pre-filing meeting
request. However, the Agency encourages certifying authorities to engage with project
proponents early in the process as they can inform decisions based on their knowledge of
the project.

2.6	Pre-Filing Meeting Requests Procedures

2.6.1 Defining Procedures for a Pre-filing Meeting

A few commenters asserted that there should be pre-filing meeting requests procedures. Some
commenters supported the idea that EPA provide a list of minimum information to include as part of pre-
filing meeting request. These commenters asserted that this would provide more clarity, nationwide
consistency and a standard approach for project proponents working with a wide range certifying
authorities. One commenter suggested that EPA should require that certifying authorities provide project
proponents with a list of requirements for information needed for the pre-filing meeting. Another

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commenter recommended that EPA modify the proposed section 121.4 to require the certifying authority
to set forth what elements must be in a project proponent's request for certification.

Some commenters opposed the idea of EPA establishing any submission procedures for the pre-filing
meeting, indicating that it would not be useful and instead suggested allowing certifying authorities
flexibility. Several of the commenters indicated that certifying authorities have already established
submission procedures and such a requirement was unnecessary and would not provide any more
certainty as the existing procedures are readily available. A couple of commenters recommended that
EPA should make clear that certifying authorities can adopt or modify applicable submission procedures
to fit with existing state processes. One commenter suggested that EPA could develop guidelines to assist
certifying authorities that do not have submission procedures in place but should not establish
requirements for those that already have them in place. One commenter suggested EPA should prohibit
certifying authorities from requiring anything but the most basic information as part of the pre-filing
meeting request such as the project proponent's name, the project activity, and the type of license or
permit.

Agency's Response: EPA is not defining by regulation the process or manner for project
proponents to submit pre-filing meeting requests or hold pre-filing meetings (e.g.,
identifying meeting subject matter or meeting participants). EPA finds that certifying
authorities are best equipped to determine their procedures and needs for pre-filing
meetings and requests. Accordingly, EPA intends the term "applicable submission
procedures" to mean the submission procedures deemed appropriate by the certifying
authority.

EPA recommends that certifying authorities provide clear expectations for pre-filing
meetings to ensure they are used efficiently and effectively. Although EPA is not defining
the process or manner for pre-filing meeting requests or pre-filing meetings, section IV.B
provides several recommendations that are good practices for all certifying authorities.
First, regarding the contents of a pre-filing meeting request when EPA acts as the certifying
authority, EPA would generally find the following submission procedures to be appropriate.
EPA recommends that project proponents submit a pre-filing meeting request to the
Agency in writing. As discussed in section IV.B in the final rule preamble, the project
proponent must submit documentation that a pre-filing meeting was requested as a
component of its request for certification when EPA is acting as the certifying authority (or
where a state or Tribe does not have defined request for certification requirements), unless
the pre-filing meeting request requirement was waived. In light of this requirement, EPA
recommends that pre-filing meeting requests to the Agency be submitted in writing. The
Agency also recommends that project proponents include the following information, as
available, in any written request for a pre-filing meeting with EPA:

1.	A statement that it is "a request for CWA section 401 certification pre-filing
meeting,"

2.	The name of the project proponent and appropriate point of contact,

3.	The name of the Tribe or jurisdiction for which EPA is serving as the certifying
authority,

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4.	The planned project location (including identification of waters of the United
States into which any potential discharges would occur),

5.	A list of any other necessary licenses/permits (e.g., state permits, other Federal
permits, etc.),

6.	The project type and a brief description of anticipated project construction and
operation activities, and

7.	The anticipated start work date.

Second, regarding the subject matter of the pre-filing meeting, EPA encourages project
proponents and certifying authorities to use the pre-filing meeting to discuss the proposed
project, as well as determine what information or data is needed (if any) as part of the
request for certification to enable the certifying authority to take final action on the request
for certification within the reasonable period of time. During the pre-filing meeting, project
proponents could share a description and map of the proposed project location and
timeline, as well as discuss potential water quality-related impacts from the activity.
Certifying authorities could use the meeting as an opportunity to provide information on
how to submit requests for certification (e.g., discuss procedural requirements for
submission of a request for certification). Certifying authorities should also consider
including the Federal agency in the pre-filing meeting process for early coordination where
the Federal agency is not otherwise legally precluded. Additionally, the final provision
provides flexibility for the certifying authority to determine whether the pre-filing meeting
request requirements are fulfilled by any pre-application meetings or application
submissions to the Federal licensing or permitting agency.

2.6.2 Exclusion of Particular Project Types from the Pre-Filing Meeting Request
Requirement

Most commenters were in favor of providing exclusions from the pre-filing meeting requirement for
certain types of projects or activities, such as activities with minor impacts such as NWPs, maintenance
and operation activities, and simple and routine projects. Many of these commenters suggested that
emergency projects should be excluded from the pre-filing meeting requirements. One commenter
suggested that the rule should explicitly state that certifying authorities have the authority to categorically
exclude certain types of projects regardless of the permit type.

A few commenters asserted that there should be no exemptions to the pre-filing meeting request
requirement, while a few other commenters suggested that exemptions should only be provided for
emergency projects.

Agency's Response: This final rule enables a certifying authority to shorten or waive the
pre-filing meeting request requirement on a case-by-case or categorical basis. For example,
certifying authorities may categorically waive or shorten the pre-filing meeting request
requirement for less complex, routine projects, as these projects most likely would not
benefit from early engagement between the project proponent and certifying authority as
large, complex projects would. Certifying authorities may also shorten or waive the pre-

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filing meeting request requirement for other reasons, such as emergency projects as noted
by commenters.

The Agency agrees with commenters that the Agency should not establish categorical
exemptions for all certifying authorities. Accordingly, the Agency is not providing an
exclusive list of reasons that a certifying authority may waive or shorten the pre-filing
meeting request requirement, nor does this final rule limit the reasons for waiving or
shortening the requirement. However, the Agency does not agree with commenters that
certifying authorities should not be able to determine when waivers are appropriate. The
final rule approach recognizes that states and Tribes are in the best position to determine
whether a particular project (or class of projects) would benefit from such early
coordination and reflects the reality that not every project will meaningfully benefit from a
pre-filing meeting.

2.6.3 Certifying Authority Written Response Within Five Days

No commenters objected to the idea that certifying authorities should respond in writing with regards to
the need for a pre-filing meeting. Several commenters suggested that EPA should explicitly require a
written response within five days to inform the project proponent of the need to have a pre-filing meeting
and establish the timeline for the pre-filing meeting if required. One commenter suggested that the rule
should include a provision that if the certifying authority does not provide a written response within five
days or is unable to hold the meeting within the 30-day time period, then the requirement for the pre-
filing meeting requirement is waived. Conversely, a few commenters argued that five days was not
sufficient time, including a few commenters who suggested that written response should be provided
within 5-10 business days.

Agency's Response: The Agency is not adding a requirement that a certifying authority
must respond in writing within five days of receipt of the pre-filing meeting request.

Instead, similar to the 2020 Rule, this final rule does not require certifying authorities to
grant or respond to a pre-filing meeting request. See 40 CFR 121.4(b) (2020). However, the
Agency is finalizing removal of the 2020 Rule provision stating that the certifying authority
is not obligated to grant or respond to a pre-filing meeting request because the regulatory
text at section 121.4 does not compel any action by the certifying authority. Accordingly, the
Agency does not find it necessary to expressly reiterate what the certifying authority is not
obligated to do. If a certifying authority fails to communicate whether it wants to waive or
shorten the pre-filing meeting request requirement, then the project proponent must wait
30 days from requesting a pre-filing meeting to submit its request for certification.
Generally, EPA expects that it will provide written acknowledgement that the pre-filing
meeting request has been received within five days of receipt. In its written response, the
Agency will also state whether it has determined that the pre-filing meeting will be waived
or when (if less than 30 days) the project proponent may submit the request for
certification.

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2.7 Input Received on Prior Rulemakings

2.7.1 Pre-proposal Input from 2021

This sub-topic summarizes input that was received prior to the 2022 proposed rule and was resubmitted
by commenters in the docket for the 2022 proposed rule.

Some stakeholders expressed support for pre-application meetings to ensure efficient and timely
certification process. One of these stakeholders said that EPA should leave the process and format up to
states. A couple of other stakeholders recommended that EPA encourage certifying authorities to create
formal or informal processes that facilitate the early coordination efforts and identify during pre-filing
meetings commonly requested information to reduce the need to issue information requests after the
certification request has been submitted. These stakeholders further recommended that EPA clarify that a
certifying authority cannot prohibit or delay the submission of a certification request following a pre-
filing meeting.

One stakeholder said that the pre-filing meeting request requirement has not been in effect that long in
regard to discussions of the benefits of these meetings.

Some stakeholders expressed concern with the pre-filing meeting request requirement. One stakeholder
said to make the pre-filing meeting request optional and eliminate the 30-day waiting period. A couple of
stakeholders said that EPA should remove the requirement and make both the pre-filing meeting request
and the meeting voluntary to provide flexibility for various circumstances including any emergency
actions. Another stakeholder called for EPA to move quickly to replace to the 2020 Rule to end harm
from the rule, including the pre-filing meeting request requirement that the commenter asserts has upset
existing state procedures and has led to delays.

A stakeholder stated that while early communication has been positive, EPA is not authorized to impose
such a requirement on states and Tribes. The stakeholder said that EPA can recommend that project
proponents ask to meet with their certifying authority before submitting a request for certification.

Agency's Response: See the Agency's Response to Comments in Sections 2.1-2.6; see also
Section IV.B of the final rule preamble.

In response to the input regarding EPA authority to impose a pre-filing meeting request
requirement, the Agency disagrees. The 2020 Rule introduced the pre-filing meeting request
requirement to encourage early coordination between parties to identify needs and concerns
before the start of the reasonable period of time. EPA interpreted, and continues to
interpret, the term "request for certification" in CWA section 401(a)(1) as being broad
enough to include an implied requirement that a project proponent shall also provide the
certifying authority with advance notice that a certification request is imminent. The time
(no longer than one year) that certifying authorities are provided under the CWA to act on
a certification request (or else waive the certification requirements of section 401(a))

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provided additional justification in this context to interpret the term "request for
certification" to allow EPA to require a pre-filing meeting request.

3. Request for Certification (Section 121.5)

3.1 Defining the Contents of a Certification Request

3.1.1 2020 Rule Approach to Request for Certification
3.1.1.1 Support 2020 Rule Approach

Several commenters asserted that the 2020 Rule's contents of a request for certification located at 40 CFR
121.5 provide certifying authorities with sufficient information to evaluate potential impacts to water
quality and opposed the proposed revisions to section 121.5. A few of these commenters asserted that the
2020 Rule's approach provides clear expectations about when the reasonable period of time begins and
eliminates any confusion regarding whether the project proponent requested certification.

Another commenter stated that the 2020 Rule's definition of a certification request is consistent with the
statute and sets a clear deadline. The commenter further added that if EPA would like the inclusion of
additional information, the 2020 Rule could be amended to require inclusion of the license or permit
application. A few commenters also observed that the 2020 Rule does not prevent a certifying authority
from requesting additional information after receiving a request for certification but reiterated that such
request should not impact the start of the reasonable period of time (e.g., provide a basis to restart the
clock).

Agency's Response: EPA disagrees with commenters asserting that the 2020 Rule's contents
of a request for certification provides all certifying authorities with sufficient information to
evaluate potential impacts to water quality. Rather, EPA finds that defining an exclusive list
of components for requests for certification for all certifying authorities, as was done in the
2020 Rule, could inhibit a comprehensive review under section 401 in the reasonable period
of time. The diverse nature of Federal licenses and permits and the variety of potential
water quality impacts from those different types of activities do not lend themselves to a
one-size-fits-all approach. Indeed, to define an exclusive list of contents would frustrate the
intent of the Act's emphasis on cooperative federalism and lead to procedural inefficiencies.
Specifically, a framework requiring the reasonable period of time to begin before the
certifying authority has essential information that it has transparently publicized as
necessary to make its own certification decision would be inconsistent with the language,
goals, and intent of the statute. Congress clearly did not intend section 401 reviews to turn
on incomplete applications, and the reasonable period of time and one-year backstop were
added by Congress to ensure that "sheer inactivity by the State...will not frustrate the
Federal application." H.R. Rep. No. 92-911, at 122 (1972).

As discussed in section IV.C.2 of the final rule preamble, the final rule's approach to the
request for certification will allow for a transparent and timely process that respects the

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role of state and Tribal certifying authorities under the cooperative federalism framework
of section 401. First, EPA finds that defining some minimum components of a request for
certification increases clarity and efficiency in the certification process. Recognizing that
some certifying authorities already have or will define additional requirements for requests
for certification they receive, EPA is only defining minimum contents for all requests for
certification. EPA finds this approach best respects longstanding state and Tribal processes
familiar to stakeholders and enables states and Tribes to determine their specific
information needs. However, EPA is also finalizing additional contents for requests for
certification to EPA or state and Tribes that fail to define such additional contents to
provide stakeholders with greater certainty and predictability in the certification process.
The final rule establishes an approach that provides efficiency for requests for certification,
while staying consistent with cooperative federalism principles and case law.

Section 401(a)(1) provides that the certifying authority's reasonable period of time to act
starts after a certifying authority is in "receipt" of a "request for certification" from a
project proponent. 33 U.S.C. 1341(a) ("If the State, interstate agency, or Administrator, as
the case may be, fails or refuses to act on a request for certification, within a reasonable
period of time (which shall not exceed one year) after receipt of such request, the
certification requirements of this subsection shall be waived with respect to such Federal
application."). The statute does not define either "request for certification" or "receipt."
While the Agency agrees with commenters that the 2020 Rule did not prevent certifying
authorities from requesting additional information after receiving a request for
certification, the final rule's approach to the request for certification is consistent with the
intent of the Act, is reasonable, is responsive to concerns and considerations raised through
the public comment process, and ultimately is the most efficient path forward.

3.1.1.2 Do Not Support 2020 Rule Approach

A few commenters generally discussed challenges with implementation of the 2020 Rule's approach to a
certification request. One commenter asserted that the 2020 Rule constrained certifying authorities'
ability to obtain information prior to commencing the reasonable period of time. The commenter also
stated that the 2020 Rule's certification request requirements led to increased confusion in the regulated
community because it did not contain the same requirements as the state's water quality certification
application. One commenter argued that 2020 Rule's approach to request for certification was inadequate
and led to a significant disconnect between Federal and state or Tribal language regarding the minimum
requirements of a certification request, leaving both vulnerable to legal challenges. Another commenter
remarked that the 2020 Rule hampered their longstanding cooperative process with the U.S. Army Corps
of Engineers for section 401 certification reviews of individual CWA permit applications by allowing for
potential disparities between what is certified and what is permitted. The same commenter stated that a
Memorandum of Agreement (MOA) ensured their involvement in the permitting process and that
proposed plans and compensatory mitigation for a project would align with what was being permitted by
the Federal permitting or licensing agency.

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Agency's Response: The Agency appreciates commenter input on the challenges associated
with implementation of the 2020 Rule's approach to a certification request. As noted in the
Agency's response to comments in Section 3.1.1.1, the Agency recognizes that defining an
exclusive list of contents would frustrate the intent of the Act's emphasis on cooperative
federalism and lead to procedural inefficiencies, such as those identified by these
commenters.

3.1.2 Inclusion of a Draft License or Permit in a Request for Certification
3.1.2.1 Support Inclusion of Draft License or Permit

Some commenters supported the inclusion of the draft license or permit in the request for certification.
Several commenters asserted that the draft license or permit would provide certifying authorities with
information essential to acting on a request, such as the Federal agency's terms and conditions. One of
these commenters also noted that the information available at the time a draft license or permit is
available would also be helpful in acting on a request (e.g., monitoring data, environmental assessment,
environmental impact statement).

Several commenters also asserted that providing certifying authorities with a draft license or permit will
lead to a more efficient, non-duplicative process, because the certifying authority will know what
preliminary conditions the Federal agency may require and identifies a clear point in time when the
certification request may be submitted. A few of these commenters provided examples to substantiate
why they believed a draft license or permit would lead to a more efficient process. One commenter noted
that administrative inefficiencies currently exist because of the lack of a draft license or permit flagging
that some states routinely deny certifications on Federal Energy Regulatory Commission (FERC) licenses
in instances where the certification request is filed prior to FERC's draft environmental impact statement
(EIS). Another commenter noted that their state was able to issue certification decisions on general
permits in a reasonable time because they receive certification requests after the draft permit is available.
Another commenter posited that inclusion of the draft license or permit would reduce the number of
denials or the need to withdraw and resubmit certification requests due to insufficient information on
hydropower projects. A few commenters also expressed support for the idea that inclusion of the draft
license or permit would allow certifying authorities to include more targeted, effective certification
conditions. One of these commenters noted that seeing how Federal agencies plan to mitigate effects may
resolve certifying authority concerns. One commenter stated that they supported improving the permitting
process by requiring a draft FERC license prior to section 401 certification review. The commenter stated
that currently, FERC review (which could take several years to complete) may lead to the expiration of a
state's one-year deadline to act on a certification request or force the state to act with incomplete
information.

Some commenters asserted that the inclusion of the draft license or permit in the request for certification
would prevent or reduce incidences where the certifying authority reviews a project that significantly
changes after submission of the application or is improperly characterized in the application. For example,
several of these commenters discussed issues with pipeline projects. One commenter provided an example
where a state had to deny certification on a pipeline project because the project proponent submitted its

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request for certification before it identified a preferred pipeline route, while a few other commenters noted
that requesting certification before FERC has provided its preferred license alternative and its
environmental analysis of that alternative is premature. A few other commenters noted that sometimes
project proponents request certification before obtaining the license or permit application number, request
certification on the wrong Federal permit, or the Federal agency will switch the permit type while the
certifying authority is reviewing the request (i.e., change from a general permit to an individual permit).

A few commenters that supported the draft license or permit requirement reflected on the challenges
associated with incorporating it into current Federal licensing or permitting processes, including one
commenter who asserted that Federal agencies would need to make substantial changes to their processes.
One commenter observed that EPA did not explain how it would ensure that Federal agencies who do not
currently issue draft licenses or permits (e.g., FERC, Corps) or begin the certification process at an earlier
point in time would align their processes with the proposed rule. However, another commenter argued
that changes to FERC and the Corps' practice would be beneficial for water quality protection, citing an
instance where the Corps failed to provide meaningful opportunities for public engagement by refraining
from sharing its project analysis until the permit was issued. This commenter further asserted that
inclusion of the draft license or permit in the request for certification would ensure that the certifying
authorities have the benefit of the Federal agency's analysis and ensure that the Federal agency's
decision-making is better informed by those whose waters might be most affected by a project, including
environmental justice communities and Tribes. Another commenter suggested that if the request for
certification includes a copy of the draft license or permit, EPA should propose a mechanism to help
Federal agencies review and revise their procedures in a timely manner. A couple of commenters
recommended that FERC could instead publish its staff s preferred alternative as part of the draft EIS.
One commenter suggested modifying the regulatory text to allow for a copy of the draft license or permit
or its equivalent.

One commenter asserted that even though the proposed rule would initiate the certification process after
the availability of a draft license or permit, it should not excuse project proponents from engaging with
the certifying authority and Federal agencies early in the application process. Another commenter
recommended that EPA should explicitly state that requiring a draft license or permit does not preclude
earlier engagement with the certifying authority.

A few commenters supported the proposal to require a copy of the draft Federal permit or license in the
certification request, but only in limited cases. These commenters suggested that a draft license or permit
should be included when a Federal agency requests certification on Federal general permits (e.g., Corps'
Nationwide General Permits).

One commenter said that EPA should move forward with the Federal agency, not the project proponent,
providing the copy of the draft license or permit to the certifying authority when it is not otherwise
already publicly available. The commenter argued that this action should be considered waived after a
reasonable period, such as 30 days, since this action is non-project proponent input. This commenter also
suggested that for projects that have longer timeframes, the Federal agency be the one required to send the
pertinent water quality concerns for a project within a timeframe such as 90 days after the pre-filing
meeting.

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Agency's Response: EPA appreciates commenter input on the proposed inclusion of a draft
license or permit in all requests for certification. After consideration of all public comments,
EPA decided to partially change the requirement in the final rule to require that all
requests for certification on an individual Federal license or permit include the Federal
license or permit application at a minimum, instead of the draft Federal license or permit.
See 40 CFR 121.5(a)(1). Many commenters opposed the inclusion of a draft license or
permit in a request for certification for various reasons, including but not limited to
possible impacts to certifying authority practice and relationships, concerns over potential
delays, and concerns over how the proposed approach would work in instances where a
Federal agency does not develop a draft license or permit, particularly for individual
Federal licenses or permits. See Section 3.1.2.2 of this Response to Comments for further
discussion of commenter concerns with the proposed approach.

EPA recognizes that with respect to general Federal licenses and permits, there often is no
formal "application," and for that reason the final rule allows the Federal agencies issuing
those general Federal licenses and permits to submit the draft general Federal license or
permit to the certifying authority instead of a Federal license or permit "application." See
40 CFR 121.5(a)(2). EPA's bifurcated approach for requests for certification for individual
Federal licenses or permits and for the issuance of general Federal licenses or permits
promotes clarity and should minimize delays in the licensing and permitting process, since
EPA anticipates most stakeholders are familiar with starting the section 401 certification
process with a Federal license or permit application (for individual licenses or permits) or
with a copy of the draft Federal license or permit (for the issuance of a general license or
permit). Additionally, this bifurcation is modeled on the separate lists for the contents of
requests for certification included in the 2020 Rule.

In response to commenter assertions that providing the draft license or permit identifies a
clear point in time when the certification request may be submitted, EPA finds that the final
rule's bifurcated approach to the request for certification also provides a clear point in time
when the certification request may be submitted. That is, a request for certification on an
individual license or permit may not be submitted until the project proponent has
submitted the proposed project's application to the Federal licensing or permitting agency,
while a request for certification on the issuance for a general license or permit may not be
submitted until the project proponent has a draft license or permit.

In response to commenter assertions regarding early engagement and regarding the level of
information available with a copy of the draft license or permit (e.g., preliminary
conditions, monitoring data), EPA observes that nothing in this final rule prevents a
certifying authority from engaging in early coordination with Federal agencies to learn
more about preliminary conditions that the Federal agency may require. Similarly, the final
rule encourages early coordination with project proponents through pre-filing meetings. To
reduce the incidences where the certifying authority reviews a project that significantly
changes after submission or is improperly characterized, certifying authorities may

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leverage pre-filing meetings to discuss the proposed project, as well as determine what
information or data is needed (if any) as part of the request for certification to enable the
certifying authority to take final action on the request for certification within the reasonable
period of time. During the pre-filing meeting, project proponents could share a description
and map of the proposed project location and timeline, as well as discuss potential water
quality-related impacts from the activity. Certifying authorities could use the meeting as an
opportunity to provide information on how to submit requests for certification. See Section
IV.B of the final rule preamble for further discussion on the pre-filing meeting process and
implementation recommendations. Additionally, to ensure certifying authorities receive
information essential to acting on the request for certification at the beginning of the
certification process, the final rule requires the project proponent to include any readily
available water quality-related materials that informed the development of the application
in all requests for certification on an individual license or permit, which may include
monitoring data. Certifying authorities may also define additional contents in a request for
certification relevant to the water quality-related impacts from the activity. If the certifying
authority determines that additional information is necessary to inform its analysis during
the certification process, nothing in this final rule prevents a certifying authority from
requesting such additional information.

In response to commenter concerns regarding incidences where project proponents request
certification before obtaining the license or permit application number or the Federal
agency switches the permit type, the final rule requirements for all requests for certification
on an individual license or permit should reduce the likelihood of this occurrence.
Specifically, the project proponent must include a copy of the Federal license or permit
application submitted to the Federal agency in any request for certification for an
individual license or permit. EPA also recommends that certifying authorities leverage pre-
filing meetings to ensure parties develop a common understanding regarding the proposed
project, such as whether the permit type is appropriate.

In response to commenter concerns regarding incidences where project proponents request
certification on the wrong federal permit, EPA observes that a Federal agency may not
issue a Federal license or permit until it obtains a certification or waiver from the certifying
authority. If the project proponent requests certification on the wrong Federal permit, or
the Federal agency changes the license or permit type during the certification process, the
project proponent must resubmit a request for certification for the appropriate Federal
permit.

EPA disagrees with the commenter asserting that the Federal agency should provide a copy
of a draft license or permit and pertinent water quality concerns to the certifying authority,
instead of the project proponent. Section 401(a)(1) requires the applicant, not the Federal
agency, to provide certification on a proposed project. See 33 U.S.C. 1341(a)(1). While the
Federal agency may, in some instances, act as the project proponent (i.e., issuance of
general licenses or permits), EPA does not find it appropriate nor necessary to shift the
statutory duty of requesting certification onto the Federal licensing or permitting agency in

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all cases. Furthermore, EPA rejects the suggestion that the Federal agency should solely
identify and provide information regarding pertinent water quality concerns. Rather, both
the statutory text and legislative history emphasize that certifying authorities, and not
Federal agencies, are responsible for determining compliance with their applicable water
quality requirements. While Federal agencies may provide useful information during the
certification process to inform a certifying authority's analysis, this final rule recognizes
that states, territories, and tribes are best equipped to identify information needs and water
quality concerns for their waters.

In response to the commenter asserting that certification decisions should be deemed
waived after a 30-day reasonable period of time, see the Agency's response to comments in
section 4 for further discussion on the reasonable period of time and section 7 for further
discussion on waivers of certification.

3.1.2.2 Do Not Support Inclusion of Draft License or Permit

Many commenters did not support the inclusion of the draft license or permit in the request for
certification. Several commenters asserted that the requirement was impractical and would create
confusion for stakeholders. One commenter argued that EPA failed to consider the practical and legal
complications of this requirement.

Agency's Response: After consideration of all public comments, EPA decided to partially
change the requirement in the final rule to require that all requests for certification on an
individual Federal license or permit include the Federal license or permit application at a
minimum, instead of the draft Federal license or permit. See 40 CFR 121.5(a)(1). Many
commenters opposed the inclusion of a draft license or permit in a request for certification
for various reasons, including but not limited to possible impacts to certifying authority
practice and relationships, concerns over potential delays, and concerns over how the
proposed approach would work in instances where a Federal agency does not develop a
draft license or permit, particularly for individual Federal licenses or permits. See the
Agency's Response to Comments in this section for further discussion on specific
commenter concerns and the Agency's responses.

3.1.2.2.1 Timing Concerns related to Statutory Text

Several commenters argued that inclusion of a draft license or permit in a request for certification was
inconsistent with CWA section 401(a)(1). A few of these commenters asserted that it was at odds with the
one year timeline, asserting that Congress did not intend for certifying authorities to have one year to act
on a request for certification after the Federal agency develops a draft license or permit. One commenter
argued that it would nullify the purpose of the reasonable period of time, because it would extend the time
that it takes the Federal agency to produce a draft. A few commenters explained the requirement would be
inconsistent with the congressional objective that the certification process not unreasonably delay the
Federal licensing or permitting process, citing to Congressional history (115 Cong. Rec. 9264 (1969);
H.R. Rep. No. 92-911, at 122 (1972)).

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A few other commenters also asserted that section 401(a)(1) makes it clear that the certification informs
development of the Federal license or permit, and not vice versa, including one commenter who argued
that certification is not intended to supplant or second-guess the licensing or permitting process after the
Federal agency has completed its review. One of these commenters noted that CWA section 401(d)
requires any certification condition to be included in the license or permit. Another commenter argued
that it would limit the conditions that could be imposed pursuant to CWA section 401(d) because the
Federal agency would have already completed its review and decision-making process.

Agency's Response: EPA disagrees that the inclusion of a draft Federal license or permit in
a request for certification is inconsistent with the statutory language or Congressional
intent. Section 401(a)(1) provides that the certifying authority's reasonable period of time to
act starts after a certifying authority is in "receipt" of a "request for certification" from a
project proponent. 33 U.S.C. 1341(a) ("If the State, interstate agency, or Administrator, as
the case may be, fails or refuses to act on a request for certification, within a reasonable
period of time (which shall not exceed one year) after receipt of such request, the
certification requirements of this subsection shall be waived with respect to such Federal
application."). The statute does not define either "request for certification" or "receipt."
Nevertheless, in light of commenter concerns described above and throughout this section,
the Agency is not finalizing the inclusion of a draft Federal license or permit in all requests
for certification. Instead, the Agency is only requiring the inclusion of a draft Federal
license or permit for requests for certification on the issuance of general Federal licenses or
permits, consistent with longstanding practice.

3.1.2.2.2 Timing Concerns related to Other Federal Processes. Coordination, and Efficiency

Several commenters raised issues with the draft license or permit requirement in relation to other Federal
statutes, regulations, or memorandum of agreement. One commenter stated that EPA ignored its existing
regulations for certification on EPA-issued NPDES permits, which allow project proponents to request
certification before issuance of the draft permit. Another commenter argued that EPA failed to
acknowledge that Federal agency procedures are based on important policy considerations and that
Federal agencies are the best suited to determining procedures to meet their statutory mandates. One
commenter argued that the draft license or permit requirement contravenes the 1976 EPA-NRC "Second
Memorandum of Understanding Regarding Implementation of Certain NRC and EPA Responsibilities,"
40 FR 60,115 (Dec. 31, 1975), which states that EPA will work to ensure that certifications are issued
before the NRC issues its final EIS. The commenter went on to note that this happens well before the
draft license or permit is available and the proposed approach would prevent NRC from considering the
certification in the final EIS. Several commenters discussed the National Environmental Protection Act
(NEPA), including one commenter who asserted that issuing a draft permit before appropriate reviews are
completed could circumvent the NEPA process. Another commenter argued having the certification
during the NEPA process can provide valuable information for the Federal agency to consider and
pointed to NRC regulations which require the NRC's NEPA evaluations to consider compliance with
water quality requirements. The same commenter also argued that it is unlikely that the draft license or
permit would contain information that would lead to quicker, fewer conditioned certifications for NRC

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projects because CWA section 511 prevents NRC from imposing its own effluent limitations or reviewing
a certification. Another commenter noted that NEPA requires consultation with certifying authorities and
asserted that EPA's proposal is telling certifying authorities to opt out of the process and would give
certifying authorities the ability to upend the environmental review process. A few commenters argued
that this requirement is contrary to long-standing government policies to encourage concurrent Federal
and state reviews under NEPA. One commenter also argued that delaying the request for certification
until the draft license or permit would prevent NRC from having information to inform its NEPA analysis
and lead to duplicative efforts that Congress sought to avoid, citing to 33 U.S.C. 1251(f).

Several commenters expressed concern that inclusion of the draft license or permit in the request for
certification would negatively impact existing coordination processes between Federal agencies,
certifying authorities, and/or project proponents, which would delay the certification process. A few
commenters noted that their states currently use joint permit applications (JPAs) or coordination
procedures for Corps projects pursuant to state regulations or law and expressed concern that the
proposed process would be impossible to integrate into their current procedures. Several commenters
noted that the proposed approach is a departure from the longstanding practice of how certifying
authorities and Federal agencies concurrently process certification requests and license or permit
applications, including some certifying authorities and Federal agencies that use combined applications
for certification and the Federal license or permit. One of these commenters argued that it is more
expeditious to process certifications in this fashion. A few commenters argued that the proposed provision
does not consider longstanding streamlining memorandums of agreement and would increase delays
without any environmental benefit. One commenter argued that not providing an opportunity for
certifying authorities and Federal agencies to coordinate their reviews could lead to unanticipated
certification denials. One commenter requested additional clarity on whether the proposed rule would
invalidate the JPA process, which the commenter argued would weaken the collaborative nature of
section 401 certification reviews.

Many of the commenters who did not support the inclusion of the draft license or permit in the request for
certification expressed concerns over the potential delays associated with this requirement, including
concern that it would create inefficiencies by delaying both the certification and Federal licensing
permitting process. One commenter acknowledged the potential value of seeing conditions in a draft
license or permit but expressed concern that this requirement (in addition to other, undefined aspects of
the proposal) would create significant delays and uncertainty for the project proponent because Federal
agencies can take months to years to develop a draft license or permit. Another commenter asserted this
proposed approach would cause significant delays because the Corps and EPA would have to complete a
rulemaking process to provide a final draft permit before they could request certification on general
permits. A few commenters argued that contrary to the Agency's claim, inclusion of the draft license or
permit would not speed up the certification process because of the time it could take to develop a draft
license or permit. One commenter asserted that while it is reasonable to ensure the certifying authority has
complete information to make a decision, it does not necessarily require waiting until the end of the
permitting process and there is no regulatory requirement to do as such, while another commenter noted
that there may still be information needs even after a draft license or permit is developed. One commenter
stated that the timing of the certification decision at the end of the Federal permitting process can result in
the Federal agency being forced to restart the environmental review process in circumstances where the

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certifying authority imposes conditions that are in conflict with the Federal agency's findings. The
commenter asserted that it would be appropriate for the certification decision to be concurrent with the
NEPA review performed by the Federal agency, so that the Federal agency can consider input from the
certifying authority during this process. The commenter argued that this approach would provide
consistency, efficiency, and integrity to the Federal decision-making process.

Agency's Response: EPA appreciates commenter concerns about possible impacts on
longstanding practice and interagency relationships and has modified this final rule to
require the Federal license or permit application, as opposed to draft Federal license or
permit, for requests for certification on an individual Federal license or permit. The
certifying authority's review of the proposed activity should be free from Federal agency
influence, allowing it to review discrete activities with potential discharges into waters of the
United States, and inform the development of a draft Federal license or permit, as opposed
to reviewing the draft Federal license or permit itself. That said, for general Federal licenses
or permits, the final rule retains the inclusion of the draft Federal license or permit for
requests for certification on the issuance of a general Federal license or permit. As
mentioned previously, general Federal licenses and permits may not have a formal
application, and thus it is the draft general Federal license or permit that likely will provide
the certifying authority with the most pertinent information in those cases. Furthermore,
this is consistent with the longstanding approach to requests for certification on the issuance
of general Federal licenses or permits and should be familiar to stakeholders. Ultimately,
EPA's bifurcated approach is consistent with longstanding certifying authority practices, is
reasonable, efficient, and should work well for both individual Federal licenses or permits
as well as for the issuance of general Federal licenses or permits.

In response to the commenter who asserted that the proposed approach would require the
Corps and EPA to complete a rulemaking process to provide a final draft permit before
they could request certification on general permits, EPA disagrees and notes that Federal
agencies have requested certification on the issuance of a general license or permit using
draft general licenses or permits for over 50 years, including under the 1971 Rule and the
2020 Rule. This final rule simply adopts an approach that is longstanding and should be
familiar to stakeholders. See also the Agency's response to comments in Section 3.1.2.4 for
further discussion on the term "draft license or permit."

3.1.2.2.3 Cooperative Federalism Principles

Several commenters asserted that the draft license or permit requirement contravened the cooperative
federalism objectives of the CWA and/or section 401. A few of these commenters argued that it would
dilute the certifying authority's role as the primary authority for determining which water quality
conditions will ensure the activity will comply with water quality standards, and do not need to rely on
the Federal agency to anticipate these conditions. A few commenters also asserted that the proposed
approach prefers the Federal agency's decision over the certifying authority's decision, with a few
commenters arguing that it would make the certification a "rubber stamp" of the draft Federal license or
permit. One commenter argued that Congress intended the certifying authority to have a role in the early

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planning process (e.g., siting, design, operation of the activity) and not an after the fact role, citing S. Rep.
91-351, at 8 (1969). Another commenter further explained that state certification was not an afterthought,
but rather certifying authorities had to conduct their own review of a project's likely effects and determine
whether they would comply with state water quality standards, citing Constitution Pipeline Co., 868 F.3d
at 101. One commenter argued that the certifying authority' s re vie w of the proposed activity must remain
free from Federal agency influence, while another commenter asserted that the certifying authority's role
is to review discrete activities with potential discharges to a water of the United States and not Federal
licenses or permits. A different commenter said that the draft license or permit could be used as leverage
against adding requirements by the certifying authority, especially if the certifying authority was not
involved in earlier discussions.

Agency's Response: EPA appreciates commenter concerns regarding the impact of
including a copy of the draft Federal license or permit in all requests for certification on
achieving the cooperative federalism principles central to section 401. Although EPA
disagrees that the proposed approach would dilute or otherwise diminish a certifying
authority's role, the Agency has modified this final rule to require the Federal license or
permit application, as opposed to the draft Federal license or permit, for requests for
certification on an individual Federal license or permit. See also the Agency's response to
comments in section 3.1.2.2.3.

3.1.2.2.4 Burden on Project Proponents

Several commenters expressed concern that potential delays from this proposed requirement would place
a burden on project proponents, including project delays, duplication of efforts, additional costs, and
could impact project viability or require costly design changes. One commenter asserted that the proposal
ignored the potential for the project proponent and Federal agency to waste time and resources if the
certifying authority ultimately denied the request for certification. Another commenter asserted that the
requirement would specifically burden small entities, who attempt to satisfy financial and legal
requirements associated with a project concurrently to achieve efficiency, rather than in a linear fashion as
the proposal suggests. Some commenters discussed potential delays associated with infrastructure projects
due to the proposed requirement, including a few commenters who asserted that the requirement would
delay projects with public safety and health implications (e.g., flood infrastructure, water supply), further
burden the supply chain, and impact American workers. Several of these commenters asserted that the
requirement is contrary to the Biden Administration's infrastructure development goals and the Permitting
Action Plan, including one commenter who argued that inclusion of the draft license or permit would
result in construction delays and cost impacts for infrastructure projects needed to meet clean energy
goals. Another commenter cited recent Council on Environmental Quality data which revealed that the
average time to complete an EIS was 4.5 years and over 6 years for some infrastructure projects and
argued that if the Federal agency waits to issue a draft permit until the EIS is completed, certification
could be delayed by another year on top of the NEPA process.

Several commenters also expressed concern over delays associated with changes to the draft license or
permit after receiving the certification, such as instances where the certification contains new or
significant information that requires an update to the draft license or permit or supplemental information

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(e.g., NEPA documentation). A few of these commenters argued that modifications to the draft license or
permit may require a new public notice or modifications to the project that would in turn require a new
section 401 certification.

Agency's Response: See the Agency's response to comments in section 3.1.2.2.

3.1.2.2.5 Burden on Certifying Authorities

A few commenters argued that delays associated with inclusion of the draft license or permit would
impact the certifying authority. One commenter asserted that the certifying authority would have added
pressure to expedite reviews, while another commenter noted that its state already struggles to complete
the certification process within one year. Another commenter argued that delays would result in Federal
intrusion into state and local control of water resources. Another commenter noted that some states
expressed concern that the proposed requirement would circumvent state permitting and approval
processes and ultimately place a burden on them. One commenter expressed concern that the inclusion of
a draft license or permit in the request for certification would force the state to have three different public
notice and potential hearing opportunities that could not be consolidated.

Some commenters also expressed concern that the proposed requirement would preclude the certifying
authority from participating in early project development or coordination with Federal agencies and
project proponents. For example, one of these commenters argued that by the time there is a draft license
or permit, it is too late to address water quality issues addressed in the early planning stage. As another
commenter noted, this may introduce new concerns that could have otherwise been addressed earlier in
the planning process. Several commenters expressed concern that this could be particularly problematic
for certifying authorities that rely on certifications to implement their regulations and do not have a
corresponding state authorization requirement.

A few commenters also expressed concern that the proposed requirement would invite conflict between
the certifying authority and Federal agency and further delay the certification process. For example, one
commenter argued that the certifying authority would have to either agree or disagree with the
representations the Federal agency made to the project proponent in the draft license or permit.
Accordingly, as another commenter asserted, that it would put an improper burden on the certifying
authority if they required design changes to the proposed activity after the project proponent and Federal
agency already invested time and effort. Similarly, another commenter noted that the certifying
authority's review of the project may lead to modifications that diverge from the project described in the
Federal permit application, and further delay the process.

Several commenters also asserted that the proposed requirement was inconsistent with current state laws
or regulations. For example, one commenter noted that requiring a draft license or permit in the
certification request would force project proponents to delay submitting their state applications to comply
with state application deadlines, while a few other commenters noted it could lead to states receiving
certification requests that do not comply with state water quality regulations because of differences in
state and Federal requirements. One commenter noted their state explicitly prevents the state from
requiring a Federal permit for their application. A few commenters expressed concern that requiring the

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draft license or permit in the request for certification would decouple the section 401 review from the
state's Coastal Zone Management Act (CZMA) review process, which requires a copy of the Federal
license or permit application.

Agency's Response: EPA appreciates commenter concerns about the impact of the
proposed approach to the request for certification on certifying authorities and has
modified this final rule to require the Federal license or permit application, as opposed to
draft Federal license or permit, for requests for certification on an individual Federal
license or permit. See the Agency's response to comments in Section 3.1.2.2.3. Nevertheless,
EPA disagrees with commenter assertions that the inclusion of a draft license or permit in
the request for certification would preclude the certifying authority from participating in
early project development or coordination with Federal agencies and project proponents.
Nothing in this final rule precludes certifying authorities from coordinating with Federal
agencies or project proponents prior to the certification process. In fact, section 121.4
requires a project proponent to request a pre-filing meeting with a certifying authority
regardless of the type of license or permit, unless the pre-filing meeting request requirement
is waived by the certifying authority. The Agency also disagrees that it would be too late to
address water quality issues if the request for certification included a draft license or
permit. A Federal license or permit may not be issued until the certifying authority either
issues a certification or waives certification. If a certifying authority evaluates an
application or a draft license or permit and determines that a proposed project will not
comply with applicable water quality requirements, the certifying authority may condition
the project to ensure compliance or deny the request for certification.

3.1.2.2.6 Practicality of Inclusion of the Draft License or Permit

Many commenters argued that inclusion of the draft license or permit in the request for certification was
impractical because Federal agencies either do not produce a draft license or permit. A few commenters
noted that Federal agencies typically rely on the certification to develop their draft license or permit,
including one commenter asserting that the draft license or permit would be inaccurate without the
certification. A few commenters noted that the proposed rule did not address situations where Federal
agencies do not provide draft licenses or permits and that it was unclear how Federal agencies could issue
draft permits, or whether they would be subject to public notice. A few commenters also noted that
requiring Federal agencies to change their license or permit process to develop a draft license or permit
would cause several issues, including creating confusion, delaying the licensing or permitting process, be
burdensome, and not be the best use of agency resources. One commenter argued that EPA failed to
justify how it could force Federal agencies to change their rules and internal procedures to comply with
the draft license or permit requirement. Several commenters specifically stated that Corps projects
(including CWA section 404 individual and general permits, Rivers and Harbors Act (RHA) section 10
permits, and civil works projects) and FERC licenses do not include a draft license or permit. When
discussing Corps permits, one commenter asserted that requiring the Corps to produce a public, draft
permit may raise legal issues, while another commenter argued that the Corps needs a certification to
ensure discharges comply with 40 CFR 230.10(b). A few commenters also indicated other Federal
licenses or permits that do not have and/or require a draft license or permit include United States

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Department of Agriculture (USDA) Forest Service authorizations, mineral authorizations, EPA-issued
NPDES permits, and Tennessee Valley Authority (TVA) permits.

A few commenters provided feedback regarding the requirement for a draft Federal license in the context
of FERC licensing. A commenter described the FERC licensing process of hydropower facilities and
stated that the requirement for a draft Federal license prior to section 401 certification review would be
inconsistent with FERC's hydropower licensing procedures. The commenter stated that applicants are
legally and factually precluded from obtaining a copy of a draft license since FERC does not issue a draft
license as part of its process. The commenter stated that this requirement would be infeasible in the
hydropower licensing context since FERC has often not finalized the EIS or Environmental Assessment
(EA) prior to the regulatory deadline to submit section 401 certifications. The commenter also stated that
delaying a certification request until the Natural Resource Commission (NRC) has developed a draft
license would not provide certifying authorities with additional information relevant to their decision and
extend project risk. Another commenter asserted that requiring a draft license for FERC hydropower
projects would not speed up the certification process for those projects because FERC's default
reasonable period of time is one year; alternatively, the commenter asserted that even if FERC changed
their default reasonable period of time to 60 days, certifying authorities would likely deny certification.

A few commenters also asserted that the draft license or permit is unnecessary because certifying
authorities have acted on a request for certification for the last 50 years without it. A commenter stated
that draft Federal license or permit applications had been sufficient to set the reasonable period of time in
their experience and asserted that it would be unnecessary and unduly problematic to require a draft
license or permit, especially in instances where the Federal agency does not have a process for issuing
draft licenses or permits. Another commenter also asserted that the draft license or permit would not
provide any additional information to the certifying authority because Federal agencies refrain from
including water quality conditions in their permits because they know it is not their primary role. One
commenter noted that in their experience in California, the state has been able to process requests for
certification without a draft permit. Another commenter noted that in the last 50 years, certifying
authorities have not unnecessarily denied or overly conditioned certification because of not knowing the
contents of a Federal permit, and argued that the Agency's concerns about lack of information are
unfounded because certifying authorities already know what conditions the Federal permits will contain
because most are issued according to standard permits.

Several commenters argued that the license or permit application is preferred over the draft license or
permit because the application contains more helpful water quality information (e.g., detailed project
description, mitigation). For example, one commenter argued the draft license or permit is not a substitute
for an application, because the application includes methods and means to address potential water quality
impacts. Another commenter noted that NRC applications for renewed licenses include an environmental
report that contains an array of information, such as discussion of the impact of the proposed action on the
environment, while Bureau of Ocean Energy Management requires a detailed construction and operation
plan that describes how activities could affect water quality. Discussing certification on FERC interstate
natural gas pipelines, another commenter noted there are ample analytical and technical studies available
for the certifying authority when the project proponent currently files its request for certification. Another
commenter stated that certifying authorities can request both information that the project proponent

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already provided the Federal agency, as well as information developed by the Federal agency as part of
their review.

Agency's Response: EPA appreciates commenter concerns about existing Federal agency
processes and recognizes that some Federal agencies do not produce a draft license or
permit for individual licenses or permits. EPA agrees that requiring submission of the draft
Federal license or permit with all requests for certification may not be worthwhile in cases
where an application contains more pertinent, water quality-related information to inform
a certifying authority's review, such as on an individual Federal license or permit.
Furthermore, in addition to being able to request additional information after receiving a
request for certification, this final rule includes other provisions to ensure certifying
authorities can obtain necessary information to inform their decision-making (e.g., ability to
establish additional requirements for a request for certification). See Section IV.C.2 of the
final rule preamble for further discussion on additional contents in a request for
certification. However, in the case of general Federal licenses or permits, EPA disagrees
with commenters that the draft Federal license or permit would not provide any real
benefit, as there would typically be no formal application to submit in those cases. The draft
general Federal license or permit will likely provide the certifying authority with the most
pertinent information in those cases. Furthermore, as noted in the Agency's response to
comments above, inclusion of the draft license or permit in a request for certification on the
issuance of a general Federal license or permit is consistent with the longstanding approach
to requests for certification and should be familiar to stakeholders. This is why EPA has
decided to finalize the bifurcated approach with different requirements for individual
Federal licenses or permits and the issuance of general Federal licenses or permits.

3.1.2.3	Neutral Opinion on Draft License or Permit

A few commenters did not express explicit support or opposition to the draft license or permit
requirement. These commenters acknowledged that the requirement was well-intentioned but noted there
could be challenges associated with the requirement.

Agency's Response: See the Agency's response to comments Section 3.1.2.1.

3.1.2.4	General Comments on Draft License or Permit

Several commenters expressed concern and confusion over the term "draft permit or license" in the
proposed rule and requested that EPA define the term to clarify the appropriate level of detail. One
commenter suggested that EPA define the term to mean the draft license or permit is ready for issuance if
it receives certification and require project proponents to submit its correspondence with the Federal
agency that authorizes the project proponents to use the draft in its request for certification. Another
commenter suggested that EPA define the term to mean the license or permit would be ready for issuance
by the Federal agency if the certifying authority grants certification. One commenter interpreted the term
"draft permit or license" to mean the final draft permit.

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One commenter asked the Agency a series of questions related to the differences between a draft and final
license or permit, including whether the Federal agency must submit a new request for certification if it
revises the draft, or whether the certifying authority can revoke its certification if the final permit is
different from the draft, and questioned whether the benefits discussed in the proposal associated with
inclusion of the draft license or permit could be realized (e.g., expediting the process). Another
commenter asserted that under their state regulations, a request for certification on the issuance of a
general license or permit must include the final general license or permit.

A few commenters asked the Agency to clarify what it means for a Federal agency to be "legally
precluded" from providing a draft license or permit. One commenter noted that it was unclear what the
phrase included, while another commenter argued that it set an excessively high standard that ignored the
difficulties associated with procuring a draft license or permit. A couple commenters provided
suggestions on how the Agency should clarify the term "legally precluded," including exempting licenses
or permits from Federal agencies who do not routinely release draft licenses or permits or who do not
provide drafts in a timely fashion or exempting draft permits for Federal permits that do not require
Federal agency notification.

One commenter stated that the Federal agency, as opposed to the project proponent, should provide the
certifying authority with the copy of the draft license or permit to ensure they receive the right draft, or
otherwise the efficiency and predictability of the certification process would be reduced. Another
commenter recommended that EPA add a provision that would require the project proponent to provide a
copy of relevant correspondence with the Federal agency in which the Federal agency authorizes the
project proponent to use the draft license or permit in its request for certification.

Agency's Response: The Agency does not find it necessary to define "draft license or
permit" for purposes of this rulemaking, in part because stakeholders should be familiar
with requesting certification on these Federal licenses or permits and Federal agencies will
be acting as the "project proponent" in these instances. The Agency observes that this final
rule does not require a Federal agency seeking certification on the issuance of a general
Federal license or permit to seek certification immediately upon publication of the draft
Federal license or permit. Rather, the Federal agency must request certification after
publication of the draft Federal license or permit. For example, the Corps is required to
request certification on the NWPs when they are renewed every five years. First, the Corps
proposes the draft NWPs and takes comment on the proposal, and later finalizes the NWPs
after considering public comment. Under this final rule, the Corps may request certification
on the NWPs after it receives and considers public comment on the proposal but before
finalizing the NWPs. In that scenario, the Corps would provide the non-finalized NWP to
the certifying authority as the draft permit in its request for certification to satisfy the
regulatory requirements. EPA encourages Federal agencies and certifying authorities to
work together to determine the point in time at which a request would be most appropriate
to allow for an informed and efficient certifying authority review. Such coordination could
also avoid questions or concerns arising over significant changes to the draft Federal license
or permit post-request. However, EPA observes that there may always be a degree of
uncertainty or possibility for project changes when it comes to certifying any project

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because a Federal agency must obtain a certification prior to issuing a Federal license or
permit. EPA encourages certifying authorities to engage early and often with project
proponents and Federal agencies and develop certification conditions that allow for
"adaptive management" in the event a project changes.

Because the Agency is not finalizing the requirement for draft license or permit in all
requests for certification, the Agency is not including the term "legally precluded" in the
final rule text at section 121.5. Accordingly, the Agency is declining to define the term
"legally precluded" in this final rule.

EPA disagrees with the commenter asserting that the Federal agency should provide a copy
of a draft license or permit to the certifying authority, instead of the project proponent.
Section 401(a)(1) requires the applicant, not the Federal agency, to provide certification on
a proposed project. See 33 U.S.C. 1341(a)(1). While the Federal agency may, in some
instances, act as the project proponent (i.e., issuance of general licenses or permits), EPA
does not find it appropriate nor necessary to shift the statutory duty of requesting
certification onto the Federal licensing or permitting agency in all cases.

In response to the commenter who recommended that EPA add a provision that would
require the project proponent to provide a copy of the relevant correspondence with the
Federal agency in which the Federal agency authorizes the project proponent to use the
draft license or permit in its request for certification, the Agency does not find it necessary
to add such a provision. As discussed in Section IV.C of the final rule preamble, the Agency
has modified this final rule to require the Federal license or permit application, as opposed
to draft Federal license or permit, for requests for certification on an individual Federal
license or permit. Although a draft Federal license or permit is required for requests for
certification on the issuance of a general Federal license or permit, the Federal agencies will
be acting as the "project proponent" in these instances. Accordingly, the Agency does not
find it necessary to add the recommended provision.

3.1.2.5 Alternatives to Inclusion of the Draft License or Permit

Many commenters supported an alternative of including either a license or permit application or a copy of
the draft license or permit. One commenter added that this would give the states and Tribes discretion to
determine the information they need. Another commenter said they were supportive of the proposed
approach as well as the alternative approach where the project proponent may submit either a copy of the
submitted license or permit application or a copy of the draft license or permit and any existing and
readily available data or information related to potential water quality impacts from the proposed project.
The commenter said these approaches would provide clarity and regulatory certainty. Another commenter
said that they did not disagree with the alternative approach of having the license or permit application or
the draft license or permit in the request for certification, but they added that the six components are
duplicative and unnecessary since the license or permit application would have that information.

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Commenters added they would support an alternative approach where the applicant would submit a copy
of license or permit to the certifying authority when it becomes available, and the certifying authority
would be able to begin its review upon receiving the application. Another commenter said that EPA
should require the submission of the license or permit application if it is not feasible for a copy of the
draft license or permit to be submitted with the request for certification.

Some commenters supported the alternative approach of including the license or permit application in the
request for certification, instead of the draft license or permit. Several of these commenters cited various
reasons for preferring the alternative, including arguing that it would maintain establish practices, avoid
regulatory delays, promote efficiencies, and ensure the certifying authority has the same information as
the Federal agency. One commenter asserted that inclusion of the application would best achieve early
coordination and consistency with the Biden Administration's Permitting Action Plan. Another
commenter asserted that to the extent EPA requires more detailed information on the license or permit,
the application is more consistent with Congress's statutory timeline. Another commenter also noted that
the Federal license or permit application would satisfy the current requirements located at 40 CFR
121.5(b)(4) and (5). A few commenters that preferred the alternative approached requested EPA clarify
that only a complete application as determined by the Federal agency should be allowed to satisfy this
requirement.

A couple of commenters expressed concern with the inclusion of the Federal license or permit application
as part of the certification request. One of these commenters argued that applications can be hundreds of
pages with many technical documents, detailed figures, and complicated calculations, making it not as
simple as it may seem. The commenter also expressed concern over the inclusion of confidential
information in the application package and recommended that EPA includes authorization for the project
proponent to redact confidential information from the application if it adopts the alternative approach.
Another commenter asserted that EPA had not adequately explained why any detailed Federal licensing
or permitting information must be included in a request for certification or how its consistent with
cooperative federalism objectives. The commenter also stated that the certifying authority can request the
application during the review process, as opposed to being a prerequisite to trigger review.

Several commenters also suggested different alternatives to including either just the draft license or
permit, or the application. One commenter suggested requiring project proponents to identify the specific
Federal permit they are seeking. Another commenter suggested requiring both the draft license or permit
and the Federal application. One commenter suggested a previous license or permit for license or permit
renewals where there are minimal or no water quality impacts. Another commenter suggested the current
list of items at 40 CFR 121.5 and the application. A few commenters specifically discussed Corp section
404 general permits, suggesting either a pre-construction notice or the general permit number, while
another commenter suggested the public notice should suffice for CWA section 404 projects. One
commenter suggested allowing a final EA or EIS could substitute for a draft license or permit for FERC
project, while another commenter suggested a draft EIS could suffice for FERC projects because it
includes the staff s preferred license alternative. A different commenter said that the submittal of a license
or permit application or a draft license or permit should be optional rather than mandatory and include
authorization for project proponents to redact any confidential information.

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Several commenters suggested that the Agency should provide greater flexibility if it opted to retain the
draft license or permit requirement, including inserting the word "if available" in the regulatory text, or
making it clear that either an application or draft license or permit would suffice. One commenter
suggested that the Agency should include a procedure where the Federal agency fails to provide a draft
license or permit. Similarly, another commenter suggested that the requirement for a draft license or
permit should be waived if the Federal agency fails to produce it after a sensible, standard period of time.
Another commenter suggested allowing the Federal agency to waive the requirement for a draft license or
permit if it does not typically issue one or if it determines, in its sole discretion, that it is not feasible. One
commenter suggested only requiring the draft license or permit for Federal agencies with a standard
period of time to develop a draft permit (or promulgate a rulemaking), and otherwise waive the
requirement for larger projects or have the Federal agency provide relevant water quality considerations
to the certifying authority.

Agency's Response: EPA appreciates the various alternative recommendations provided by
commenters on this topic. After reviewing public comments, EPA decided to partially
change the requirement in the final rule to require that all requests for certification on an
individual Federal license or permit include the Federal license or permit application at a
minimum, instead of the draft Federal license or permit. Allowing a project proponent to
submit a request for certification on an individual Federal license or permit with only the
application may result in the reasonable period of time starting earlier in the Federal
licensing or permitting process in most circumstances, thus avoiding or minimizing any
delay in the overall Federal licensing or permitting process. EPA also agrees with
commenters that this approach would maintain established practices, avoid regulatory
delays, promote efficiencies, and ensure the certifying authority has the same information
as the Federal agency.

With respect to general Federal licenses and permits, as stated above, there is no formal
application, nor is there a similar event preceding the issuance of the general Federal license
or permit at which time EPA could logically tie with the submission of a request for
certification. EPA's bifurcated approach for requests for certification for individual
Federal licenses or permits and for the issuance of general Federal licenses or permits
promotes clarity and should minimize delays in the licensing and permitting process, since
EPA anticipates most stakeholders are familiar with starting the section 401 certification
process with a Federal license or permit application (for individual licenses or permits) or
with a copy of the draft Federal license or permit (for the issuance of a general license or
permit).

The Agency does not view the application and any subsequent draft license or permit to be
interchangeable for purposes of this final rule. While nothing in this final rule precludes a
project proponent from providing the certifying authority with a copy of the draft license or
permit for an individual license or permit, where available, it is not a mandatory
requirement for a request for certification on an individual license or permit for reasons
discussed in Section 3.1.2 of the Agency's Response to Comments. Indeed, EPA encourages
project proponents to communicate early and often with certifying authorities to determine

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information needs and provide any other relevant water quality-related information during
the certification process where such other information is not already required by this final
rule. Such coordination and facilitation of information sharing could support a more
efficient certification process.

The Agency disagrees with commenters who suggested different alternatives to including
either the draft license or permit or the application, or suggested that the Federal license or
permit application or draft Federal license or permit should be optional. The Agency finds
that a Federal license or permit application (for requests for certification on individual
licenses or permits), or the draft Federal license or permit (for requests for certification on
the issuance of general licenses or permits) is reasonable for an informed, efficient
certification review process, as discussed in more detail below.

EPA appreciates commenter concerns with the inclusion of the Federal license or permit
application as part of the request for certification, but finds this information is reasonably
necessary for a certifying authority to conduct a fully informed review of a request for
certification within the reasonable period of time and to achieve the cooperative federalism
principles central to section 401. Allowing for standardized minimal requirements, such as
the Federal license or permit application, will improve the quality of section 401 reviews,
particularly for certifying authorities with limited resources. The minimal components also
contain essential water quality-related information. The Federal license or permit
application may contain, for example, information on project design, specifications,
location, and potential discharges that are critical to a certifying authority's review for
compliance with water qualtiy requirements. The final rule also requires project
proponents to provide any readily available water quality-related materials that informed
the application or draft general license or permit, which recognizes the importance of
providing certifying authorities with critical information to inform their analysis while at
the same time considering important implementation details. First, this requirement
provides a predictable endpoint for project proponents because it is limited to existing data
or information that was used in the development of the license or permit application or the
draft general license or permit. Second, consistent with the scope of review under this final
rule, this requirement limits any such materials to "water quality-related materials," which
will ensure that project proponents provide certifying authorities with pertinent water
quality-related information to fully inform their certification analyses. While EPA
acknowledges that nothing in this final rule prevents certifying authorities from requesting
more information after receiving a request for certification, the minimal contents defined at
section 121.5(a) of this final rule will allow for more predictable, efficient certification
reviews.

In response to commenter concerns regarding inclusion of confidential information in an
application, EPA has clarified in the final rule preamble that project proponents may
redact or exclude personally identifiable information (e.g., personal addresses, personal
finance information) and/or other sensitive information. See Section IV.C.2 of the final rule
preamble.

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In response to the commenter that requested EPA clarify that only a complete application
as determined by the Federal agency should be allowed to satisfy this requirement, the final
rule requires the project proponent to submit a copy of the license or permit application
that was submitted to the Federal agency. EPA encourages certifying authorities to
communicate with project proponents and Federal agencies (i.e., through a pre-filing
meeting) to discuss what information or data is needed (if any) as part of the request for
certification to enable the certifying authority to take final action on the request for
certification within the reasonable period of time, such as complete applications.

3.1.3 Inclusion of "Any Existing and Readily Available Data or Information related to
Potential Water Quality Impacts from the Proposed Project"

3.1.3.1 Support Inclusion of "Any Existing and Readily Available Data or Information"

Several commenters supported the requirement that the request for certification include "any existing and
readily available data or information related to potential water quality impacts from the proposed project."
A few of these commenters noted that this information is important for decision-making and allows
certifying authorities to better evaluate potential impacts of a project. Another commenter noted that this
requirement by itself is more than adequate for an informed decision. One commenter suggested that the
Agency should clarify that project proponents should not use the phrase "readily available" as an excuse
to fail to provide the certifying authority with what it reasonably needs to begin the review process.

A few commenters asserted that while they supported the requirement, the Agency should not limit
certifying authorities to "any existing and readily available" and suggested deleting the phrase or
clarifying that it should not be construed to restrict a certifying authority from requesting new, additional,
or not-yet available data related to the proposed activity.

Agency's Response: EPA intended that providing certifying authorities with any existing
and readily available data or information related to potential water quality impacts from
the proposed project, such as studies or an EIS or EA or other water quality monitoring
data, would reduce the need for duplicative studies and analyses. In response to commenter
concerns, as summarized in section 3.1.3.2 below, EPA is adjusting the regulatory text in the
final rule to read "any readily available water quality-related materials that informed" the
application or draft general Federal license or permit. See 40 CFR 121.5(a)(l)(ii),
121.5(a)(2)(ii). EPA recognizes the importance of providing certifying authorities with
necessary information to inform their analysis while at the same time considering important
implementation details. First, this revision provides a predictable endpoint for project
proponents because it is limited to existing data or information that was used in the
development of the Federal license or permit application or the draft general Federal
license or permit. Second, consistent with the scope of review under this final rule, this
revision limits any such materials to "water quality-related materials." This will ensure that
project proponents provide certifying authorities with pertinent water quality-related
information to fully inform their certification analysis. EPA also finds that limiting such

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materials to "water quality-related" should clarify that project proponents may redact or
exclude personally identifiable information (e.g., personal addresses, personal finance
information) and/or other sensitive information.

EPA appreciates commenter concerns regarding the exclusion of information on the
proposed activity that may be unavailable (e.g., data). However, as discussed above, EPA
finds it reasonable and appropriate for the Agency to balance certifying authority
information needs with legitimate implementation concerns by limiting the default
requirements to existing, readily available information. If there are other materials that did
not necessarily "inform the development" of the application or draft Federal license or
permit (e.g., section 402 permit factsheets, permit description presentations, etc.), the
certifying authority is free to define such materials in its additional contents for a request
for certification, see discussion infra, or request such additional information after receiving
a request for certification. A project proponent is also welcome to include any additional
information in the request for certification. Furthermore, certifying authorities are
encouraged to use the pre-filing meeting request process to further communicate
appropriate water quality-related materials that would be helpful in reviewing a request for
certification on an individual Federal license or permit.

3.1.3.2 Do Not Support Inclusion of "Any Existing and Readily Available Data or Information"

Many commenters did not support the requirement that the request for certification include "any existing
and readily available data or information related to potential water quality impacts from the proposed
project," arguing that it was unclear and would be difficult to implement. A few commenters argued that
the requirement would lead to unintended consequences, create confusion, and delay the certification
process. One commenter asserted that the requirement is inconsistent with section 401(a)(1) because it
does not state or imply that a "request for certification" must include information beyond the request
itself. Another commenter argued that EPA lacks authority to dictate states and Tribes' information needs
in administering a section 401 program, asserting that the requirement has no support in statutory text or
purpose and is inconsistent with EPA's prior recognition that states and Tribes should be empowered to
determine what information is necessary to start the certification process, citing the 1989 Guidance.

Several commenters asserted that the "any existing and readily available data" requirement was vague and
ambiguous and expressed concern that the open-endedness could invite certifying authorities to
subjectively determine when submissions are or are not requests for certification. One of these
commenters asserted that some states would expansively construe what data may be "readily available"
and immoderately define what "impacts" are "related" to the proposed project based on their prior
experience, while another commenter expressed concern that such a requirement would lead to disputes
regarding completeness. One commenter expressed concern that the requirement would allow certifying
authorities to require project proponents to conduct additional research and delay projects. Another
commenter argued that the requirement exceeded the scope of section 401 because it would require
information related to potential water quality effects from the proposed project, rather than just the
discharges for which certification is required. The commenter further asserted that there is no need to
require this information because it is in the applicant's benefit to provide the certifying authority with

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such information and the certifying authority can always deny the request if they are missing information.
One commenter stated that the requirement to submit "existing and readily available data" is vague and
would cause significant licensing delays because the applicant has no way to confirm what a complete
submission would require.

A few commenters sought clarification from EPA as to what is expected for this requirement beyond the
examples provided in the preamble. Some commenters expressed concern over the examples EPA
provided in the proposal when discussing "any existing and readily available data." One commenter
asserted that waiting until aNEPA document is available would cause significant delays. Another
commenter stated that the proposed rule preamble inconsistently used different examples throughout and
asserted that it could cause uncertainty for project proponents and certifying authorities.

Several commenters recommended that EPA define the term "any existing and readily available data or
information related to potential water quality impacts from the proposed project." One commenter
asserted that "existing" is too broad because some facilities have existed for decades and may have
immense amounts of data than is necessary for certification. Similarly, another commenter expressing
similar concerns recommended using "current and most relevant" in lieu of "any" to ensure certifying
authorities use the most appropriate data. A few commenters suggested that EPA should specify the types
of documents or information that would fit this requirement to ensure transparency and consistency, while
another commenter suggested that it should be limited to information the project proponent has in their
possession when they submit the request. A few commenters asserted that the term was insufficient and
suggested that EPA should either require the project proponent to accurately identify the extent of waters
affected by a proposed project or identify measures to mitigate or eliminate violation of water quality
standards.

One commenter opposed the inclusion of "any existing and readily available data or information related
to potential water quality impacts from the proposed project," but stated that if EPA decides to require
additional information, then they would not object the alternative of requiring a copy of the license or
permit application.

Agency's Response: EPA appreciates commenter concerns regarding the inclusion of the
term "any existing and readily available data or information related to potential water
quality impacts from the proposed project." In response to these comments, EPA is
adjusting the regulatory text in the final rule to read "any readily available water quality-
related materials that informed" the application or draft general Federal license or permit.
See the Agency's Response to Comments in section 3.1.3.2. EPA does not find it necessary to
define the term "any readily available water quality-related materials that informed" the
application or draft general Federal license or permit since the term is clearly limited to
existing water quality-related data or information that was used in the development of the
Federal license or permit application or the draft general Federal license or permit.
Examples of these readily available materials include maps, studies, or a reference to a
website or literature that contain information that informed the development of the
application or draft license or permit. The Agency provided these examples in the final rule
preamble and clarified that they are materials that are in the project proponent's

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possession or easily obtainable. In response to commenters requesting that the Agency
should require the project proponent to accurately identify the extent of waters affected by
a proposed project or identify measures to mitigate or eliminate violations (i.e.,
exceedances) of water quality standards, the Agency notes that this final rule allows
certifying authorities to define what information, in addition to a copy of the Federal license
or permit application and any water quality-related materials that informed the
development of the application, is necessary to make an informed decision regarding
protecting their water quality from adverse effects from a federally licensed or permitted
activity. As such, certifying authorities may define additional information, such as
information suggested by commenters, to the extent it is consistent with this final rule (i.e.,
additional information that is relevant to the water quality-related impacts from the activity
and identified prior to when the request for certification is made).

EPA disagrees with the commenter asserting that project proponents should only be
required to provide information related to potential water quality effects from the
discharges for which certification is required. See Section IV.E of the final rule preamble
and Section 5 of the Agency's Response to Comments for further discussion on the activity
scope of certification. EPA also disagrees with the commenter's assertion that EPA does not
need to require such information in a request for certification. Although the Agency agrees
with the commenter that it is to the applicant's benefit to provide the certifying authority
with such information and the certifying authority can always deny the request if they are
missing information, EPA finds that defining some minimum components of a request for
certification increases clarity and efficiency in the certification process.

EPA disagrees with the commenter asserting that EPA lacks authority to define any
contents in a state or Tribes' request for certification or the suggestion that this final rule
does not empower states and Tribes to determine what information is necessary to start the
certification process. The text of section 401 does not define the contents of a "request for
certification" or specify at what point in the Federal licensing or permitting process such a
request must or may be submitted to the certifying authority. As discussed in Section IV.C.2
in the final rule preamble, EPA finds that defining some minimum components of a request
for certification increases clarity and efficiency in the certification process. Recognizing that
some certifying authorities already have or will define additional requirements for requests
for certification they receive, EPA is only defining minimum contents for all requests for
certification. In order to effectuate Congress' goals and directives for section 401 in the
limited amount of time provided by the Act, it is reasonable that certifying authorities
should be able to define what information, in addition to a copy of the Federal license or
permit application and any water quality-related materials that informed the development
of the application, is necessary to make an informed decision regarding protecting their
water quality from adverse effects from a federally licensed or permitted activity. EPA finds
this approach best respects longstanding state and Tribal processes familiar to stakeholders
and enables states and Tribes to determine their specific information needs.

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3.1.4 Certifying Authorities' Ability to Define Additional Contents in a Request for
Certification

3.1.4.1 Support Certifying Authorities Defining Additional Contents

Many commenters supported the proposed approach of allowing certifying authorities to define the
contents of a request for certification. Commenters provided a variety of reasons why they supported this
approach, including asserting that it will ensure a comprehensive review under section 401 in the
reasonable period of time and enable states and Tribes to ensure they have needed information to
determine whether a project will protect water quality. As a result, these commenters asserted that the
certification process will be more efficient and predictable. Some commenters argued that it was
unreasonable to start the reasonable period of time before the certifying authority has all the necessary
information to make the certification decision. A few commenters argued that this approach aligns with
cooperative federalism principles and certifying authorities are best equipped to determine what
information they need, including one commenter who noted that many states already have regulations or
guidance documents detailing what they need to make a certification decision. A few other commenters
also noted that this approach allows states to determine what constitutes a request in accordance with their
administrative requirements. One commenter noted that this approach would allow states to synchronize
section 401 certification review with CZMA consistency review, while another commenter asserted that
this approach would allow states or Tribes to incorporate elements addressing state or Tribal water quality
standards, codes, or hydrology.

Several commenters argued that the proposed approach was an improvement over the 2020 Rule's "one-
size fits all" approach to request for certification. These commenters asserted that the 2020 Rule upended
decades of practice, promoted inefficiencies, and prevented certifying authorities from having critical
information to make certification decisions. A few commenters noted that the 2020 Rule's approach
would force unnecessary certification denials due to lack of information.

Several commenters requested that the Agency clearly state where the certifying authority has identified
required contents of a request for certification, a request for certification must comply with those
requirements. One commenter noted that proposed section 121.5(b) does not include an express reference
to where the certifying authority has identified contents of a request for certification. One commenter
asserted that EPA could provide certifying authorities with the flexibility to identify additional
information on an application-by-application basis. A few commenters suggested that the final rule should
clarify that certifying authorities may require environmental review documents before the start of the
reasonable period of time, such as jurisdictional determinations or the information required for a complete
Federal application. Another commenter suggested that the Agency should add a provision that allows the
certifying authority to identify any additional information reasonably necessary to determine the potential
water quality impacts of the proposed project and appropriate methods and means to address such
impacts. One commenter requested EPA expressly define certification request to include any applicable
requirements by a certifying authority.

Some commenters asserted that by allowing the certifying authority to set the minimum requirements, and
requiring those minimum requirements to be in regulation, the project proponent, the certifying authority,

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and the public would be fully informed of when the reasonable period of time begins and ends. One
commenter agreed that certifying authorities should explain in advance the expected contents of
certification requests, however, providing some information responsive to those expectations should not
establish that a certification request has been received sufficient to initiate the reasonable period of time.
Accordingly, the commenter asserted that the certifying authority is authorized to request any additional
information necessary to clarify the information provided in the application before deeming a certification
request complete. The commenter noted that the approach would result in more efficient section 401
decisions as project proponents would be incentivized to promptly respond to requests for information to
"complete" their certification requests and initiate the "reasonable period of time," and certifying
authorities would not be forced to use limited resources processing requests without the information they
need.

Several commenters disagreed that certifying authorities should be limited to defining the contents of a
request for certification in regulation. One commenter asserted that such an approach was not supported
by the plain language of the CWA. A few commenters asserted that the request does not need to be in a
regulation to be transparent or publicly available, while a few commenters urged EPA to consider that
some state processes are well-known to the regulated community or have been used for 50 years. A few
of these commenters argued that states use different approaches to defining the contents of a certification
request, including statute, policy documents, application forms, and guidance. These commenters asserted
that placing the contents of a request in regulation was an unnecessary burden, time consuming (e.g., may
require legislature approval before going into effect), and interferes with a state's ability to describe the
information in certification request. Another commenter suggested that the required elements should be
identified during pre-filing meetings. One commenter suggested that EPA should seek information about
state and Tribal rulemaking processes first. Another commenter observed that EPA did not discuss a grace
period for states to identify regulatory gaps, while a different commenter suggested that EPA should
provide a transition period for states and Tribes without regulations so they can initiate the rulemaking
process. A few commenters suggested either removing the regulatory requirement, modifying the
regulatory text to read "regulation or other state law requirement," or clearly requiring project proponents
to comply with applicable state administrative procedures.

Agency's Response: EPA agrees with commenters that certifying authorities are best suited
in determining their information needs for making their certification decisions. Allowing
certifying authorities to identify additional required contents relevant to the water quality-
related impacts from the activity prior to when the request for certification is made is
consistent with the proposal and the intent of the Act, is reasonable, responsive to concerns
and considerations raised through the public comment process, and ultimately is the most
efficient path forward.

The Agency finds it is reasonable for states and Tribes to have the authority to determine
what information is necessary to initiate the certification process under section 401 in
compliance with their own water quality requirements. In order to effectuate Congress'
goals for section 401 in the limited amount of time provided by the Act, it is reasonable that
certifying authorities should be able to define what information, in addition to a copy of the
Federal license or permit application and any water quality-related materials that informed

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the development of the application, is necessary to make an informed decision regarding
protecting their water quality from adverse effects from a federally licensed or permitted
activity. EPA agrees with commenter assertions regarding the 2020 Rule's approach to the
contents of a request for certification (i.e., defining an exclusive list of components for all
requests for certification). Defining an exclusive list of components for requests for
certification for all certifying authorities could inhibit a comprehensive review under
section 401 in the reasonable period of time. The diverse nature of Federal licenses and
permits, and the variety of potential water quality impacts from those different types of
activities, does not lend itself to a one-size-fits-all approach. Indeed, to define an exclusive
list of contents would frustrate the intent of the Act's emphasis on cooperative federalism
and lead to procedural inefficiencies. Specifically, a framework requiring the reasonable
period of time to begin before the certifying authority has essential information that it has
transparently publicized as necessary to make its own certification decision would be
inconsistent with the language, goals, and intent of the statute. Congress clearly did not
intend section 401 reviews to turn on incomplete applications, and the reasonable period of
time and one-year backstop were added by Congress to ensure that "sheer inactivity by the
State...will not frustrate the Federal application." H.R. Rep. No. 92-911, at 122 (1972).
Moreover, this approach should be familiar to project proponents who would have followed
specific requirements established by states and Tribes during the last approximately 50
years. The Agency's final approach will allow for a transparent and timely process that
respects the role of state and Tribal certifying authorities under the cooperative federalism
framework of section 401.

EPA has made changes regarding to the manner in which certifying authorities may define
additional contents for a request for certification. The Agency originally proposed that the
contents of a request for certification be established by a state or authorized Tribe in
regulation. After considering public comments, the Agency is not requiring a state or Tribe
to define additional contents of a request for certification in regulation. The Agency agrees
that that the required contents of a request do not need to be specifically in a regulation to
be transparent, publicly available, and provide project proponents with adequate notice.
The critical inquiry for state and Tribal certifying authorities to consider is whether the
method of identifying the required contents in a request for certification is clear, objective,
and authoritative such that notions of fairness and notice are served. The Agency notes that
some of the state and Tribal processes are already well known to the regulated community,
have been used for 50 years, and are not in regulation. As a practical matter, states and
Tribes use different approaches to define the required contents of a request for certification,
including statutes, regulations, policy documents, application forms, and guidance. The
burden of putting the contents of a request in regulation can be time consuming (e.g., may
require legislature approval before going into effect), and may interfere with certifying
authorities' ability to describe the information they expect in a request for certification.

EPA appreciates commenter suggestions regarding additional contents. While EPA is not
including additional contents aside from those listed in section 121.5(b), the Agency
emphasizes that certifying authorities are free to define additional contents for their

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requests for certification. As discussed in section IV.C.2 of the final rule preamble, EPA has
adjusted the language in the final rule to increase flexibility for certifying authorities to
define the additional contents of a request for certification in regulation or another
appropriate manner, such as an official form used for requests for certification. However,
EPA emphasizes that such additional contents should be communicated clearly and
transparently for project proponents to be aware of before submitting a request for
certification. For example, EPA finds that an additional component that "requires a project
proponent to submit any additional information to inform whether any discharge from the
proposed activity will comply with applicable water quality requirements" by itself would
be too vague and would not provide project proponents with a clear, predictable
requirement for a request for certification.

In response to the commenter who requested that EPA should provide certifying authorities
with the flexibility to identify additional information on an application-by-application basis,
the Agency notes that nothing in this final rule precludes a certifying authority from
defining different lists of additional components by project type, project size, etc. However,
a certifying authority must define such additional components before a request for
certification is made. If the certifying authority fails to identify such additional components
before the request for certification is made, the project proponent must submit the
additional components defined at section 121.5(b). If the certifying authority later
determines that additional information would be helpful to inform its decision-making on a
request for certification, this final rule does not preclude the certifying authority from
asking for additional information after a certification request is submitted. But the
certifying authority cannot require additional components, aside from contents listed at
section 121.5(a) and 121.5(b), in a request for certification, if it did not already define such
additional components prior to receiving the request for certification. As discussed above,
the final rule's approach ensures that certifying authorities communicate additional
components in a way that is transparent, publicly available, and provides project
proponents with adequate notice.

Relatedly, the Agency disagrees with the commenter asserting that certifying authorities
should be able to request any additional information necessary to clarify the information
provided in the application before deeming a request for certification complete. While the
Agency recognizes the importance of ensuring certifying authorities being able to define
additional information that is necessary to make an informed decision, the Agency also
recognizes the importance of providing project proponents with clear and adequate notice
of the required contents in a request for certification. The Agency's final rule requires
certifying authorities to clearly communicate additional components to project proponents
and encourages certifying authorities to utilize the pre-filing meeting process to convey how
the project proponent may satisfy such additional components. As noted above, nothing
precludes the certifying authority from asking for additional information after a
certification request is submitted, but that is separate from the issue of what information is
required.

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In response to commenters, the Agency restructured section 121.5 to clarify which
components are required for all requests for certification versus which components depend
on the certifying authority. Section 121.5(c) clarifies that if the certifying authority is a state
or authorized Tribe that has identified additional contents for a request for certification,
then the project proponent must include those additional contents in a request for
certification.

3.1.4.2 Do Not Support Certifying Authorities Defining Additional Contents

Some commenters did not support the proposed approach of allowing certifying authorities to define the
contents of a request for certification and asserted that EPA should define a uniform list of contents for all
requests for certification. One commenter stated that the Federal regulations should provide an
unambiguous, well-defined definition for request for certification so that project proponents, certifying
authorities, and Federal agencies know what entails a "proper" certification request. A few commenters
asserted that the proposed approach would allow certifying authorities to issue regulations that broadly
expand the contents of a request for certification without any oversight or limits. A commenter provided
an example in which a certifying authority deemed a certification request for a proposed pipeline project
to be incomplete for reasons other than potential water quality impacts.

Some commenters argued that EPA is inviting certifying authorities to engage in the types of practices
that were rejected by the Second Circuit in N. Y. State Dep 't of Env 't Conservation v. FERC, 884 F.3d 450
(2d Cir. 2018). Some commenters asserted that certifying authorities would vaguely or broadly define the
minimum contents or require information that was currently unavailable to stall the start of the reasonable
period of time. A few commenters expressed concern over the approach and its departure from the 2020
Rule. One of these commenters asserted that certifying authorities may not clearly identify what
information is needed for a certification request and the proposed rule could not enforce any transparency
requirements against certifying authorities. The same commenter also argued that the 2020 Rule sought to
curb actions, such as certifying authorities using vague and shifting demands for information on fossil
fuel infrastructure projects to prolong the application process, and that EPA should not allow these
practices to return. Another one of these commenters asserted that EPA knows some certifying authorities
subjectively define the contents in a certification request to prolong the review process and asserted they
will continue to do so under this proposed approach without any oversight or minimal guidelines. The
commenter citedMcMahan Hydroelectric, LLC, 168 FERC " 61,185 at P 38, n.44 (2019) and State ex rel.
State Water Res. Control Bd. v. FERC, 966 F.2d 1541, 1554 (9th Cir. 1992) to support the proposition
that certifying authorities will continue to ask for more data to lengthen the time to review a request for
certification in contravention of Congressional intent. The same commenter argued that EPA's proposed
approach was arbitrary and capricious because EPA did not associate a single adverse environmental
outcome with the 2020 Rule's approach. Some commenters argued the result would be a multi-
jurisdictional patchwork of different requirements placing undue burdens on project proponents,
especially for projects that span across multiple states, and that certain certifying authorities would veto
multi-state projects. One commenter asserted that EPA should define one list applicable to all certifying
authorities to avoid unwarranted delays and promote predictability, arguing that prior to the 2020 Rule,
deferring to certifying authorities led to subjective treatment of projects, scope creep, unwarranted delays
and denials, and litigation. The commenter also requested that EPA clarify and support the statement that

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the 2020 Rule requirements "resulted in the state issuing more denials due to project proponents not
submitting information necessary for project evaluation," arguing that the 2020 Rule did not prevent
certifying authorities from asking for more information.

One commenter asserted that EPA cannot delegate the ability to define additional requirements for a
certification request to certifying authorities, arguing that deference is owed to EPA, not certifying
authorities, because Congress gave EPA regulatory power in the CWA. The commenter also asserted that
allowing a certifying authority to determine when it has received sufficient information to begin the
reasonable period of time provides essentially no limitation on the review period, in comparison to the
Federal Rules of Civil Procedure, and argued that a complete certification request is a separate question
from whether a request is submitted. The commenter continued to explain that Congress made it clear that
the review period is premised on a request and not detailed information, and that the proposal is contrary
to clear Congressional intent, implicates Due Process concerns, and would hinder the permitting process
and frustrate infrastructure development.

Another commenter asserted that the proposed approach would allow certifying authorities to require
certification requests to include information unrelated to CWA section 404's purpose to regulate the
discharge of dredged or fill material and would lead to a more burdensome request process. The
commenter also asserted that states and Tribes have other laws and regulations to ensure Federal
approvals subject to section 401 are reviewed.

A few commenters who did not support the proposed approach of allowing certifying authorities to define
the contents of a request for certification suggested EPA should put boundaries on such abilities. For
example, one commenter suggested boundaries to remain consistent with legal precedent and avoid
exhaustive or vague lists that a certifying authority could continually deem incomplete. Another
commenter asserted that Due Process and basic fairness require certifying authorities to publish such
contents clearly and authoritatively and asserted that EPA should clarify that certification request
requirements and receipt timing cannot be tied to procedures or requirements that are not adopted and
published as regulations. Similarly, another commenter requested that EPA direct certifying authorities to
publish detailed requirements for a completed request for certification and timelines for review, asserting
that it would promote transparency and consistency. Another commenter suggested that EPA must take
steps to ensure certifying authorities' additional requirements are objective, predictable, consistent, and
transparent, and asserted that EPA should approve certifying authority additional requirements to ensure
they do not become overly burdensome or complicated. The same commenter also suggested that EPA
should establish a lead agency to ensure projects move forward while allowing states to develop their own
certification request requirements (e.g., monitoring if applications are continuously being sent back, then
it could suggest that additional requirements are too high of a threshold for project proponents). Another
commenter suggested EPA establish guidelines around what is a complete application to protect states
with limited staffing capacity.

One commenter recommended that EPA consider other alternatives such as requiring states and Tribes to
alter their requirements for requests for certifications to match those of the Federal agency. The
commenter argues this would ensure the information submitted to the Federal agency matches the
information provided to states and Tribes.

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Some commenters argued that a certifying authorities' ability to request additional information coupled
with their ability to deny a request renders the right to specify contents unnecessary. These commenters
argued that project proponents have a strong incentive to avoid denial and provide all requested necessary
information. A few of these commenters argued that nothing but the request itself is permitted under the
statute.

Agency's Response: As an initial matter, the Agency disagrees with commenter assertions
that EPA is somehow "delegating" any authority provided under the Act to certifying
authorities or that section 401 clearly defines what a "request for certification" entails.
Section 401(a)(1) provides that the certifying authority's reasonable period of time to act
starts after a certifying authority is in "receipt" of a "request for certification" from a
project proponent. 33 U.S.C. 1341(a) ("If the State, interstate agency, or Administrator, as
the case may be, fails or refuses to act on a request for certification, within a reasonable
period of time (which shall not exceed one year) after receipt of such request, the
certification requirements of this subsection shall be waived with respect to such Federal
application."). The statute does not define either "request for certification" or "receipt." As
discussed in Section IV.C.2 in the final rule preamble, EPA finds that defining some
minimum components of a request for certification increases clarity and efficiency in the
certification process. Recognizing that some certifying authorities already have or will
define additional requirements for requests for certification they receive, EPA is only
defining minimum contents for all requests for certification. In order to effectuate
Congress' goals and directives for section 401 in the limited amount of time provided by the
Act, it is reasonable that certifying authorities should be able to define what information, in
addition to a copy of the Federal license or permit application and any water quality-related
materials that informed the development of the application, is necessary to make an
informed decision regarding protecting their water quality from adverse effects from a
federally licensed or permitted activity. EPA finds this approach best respects longstanding
state and Tribal processes familiar to stakeholders and enables states and Tribes to
determine their specific information needs.

Relatedly, the Agency also strongly disagrees with the commenter assertions that allowing
certifying authorities to define additional contents would "provide[] essentially no limitation
on the review period" or that a complete request for certification is a different question
from when a request is submitted. Although commenters are correct in that the reasonable
period of time begins once a certifying authority receives a request for certification, the
commenters fail to explain how anything other than the Agency's approach in the final rule
would achieve Congress' goals and directives provided in section 401. Indeed, in order to
effectuate Congress' goals and directives for section 401 in the limited amount of time
provided by the Act, it is reasonable that certifying authorities should be able to define what
information, in addition to a copy of the Federal license or permit application and any
water quality-related materials that informed the development of the application, is
necessary to make an informed decision regarding protecting their water quality from
adverse effects from a federally licensed or permitted activity.

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One commenter also asserted that allowing certifying authorities to define additional
contents in a request for certification would hinder the permitting process and frustrate
infrastructure development; yet the opposite is true. The commenter fails to address or
reconcile the reality that defining an exclusive list of components for requests for
certification for all certifying authorities could inhibit, and in fact has inhibited, a
comprehensive and efficient review under section 401 in the reasonable period of time. See,
e.g., the comment summaries and the Agency's response to comments in Section 3.1.1. The
diverse nature of Federal licenses and permits and the variety of potential water quality
impacts from those different types of activities do not lend themselves to a one-size-fits-all
approach. Indeed, to define an exclusive list of contents would frustrate the intent of the
Act's emphasis on cooperative federalism and lead to procedural inefficiencies. Specifically,
a framework requiring the reasonable period of time to begin before the certifying
authority has essential information that it has transparently publicized as necessary to
make its own certification decision would be inconsistent with the language, goals, and
intent of the statute. Congress clearly did not intend section 401 reviews to turn on
incomplete applications, and the reasonable period of time and one-year backstop were
added by Congress to ensure that "sheer inactivity by the State...will not frustrate the
Federal application." H.R. Rep. No. 92-911, at 122 (1972). Moreover, this approach should
be familiar to project proponents who followed specific requirements established by states
and Tribes during the last approximately 50 years. The Agency's final approach will allow
for a transparent and timely process that respects the role of state and Tribal certifying
authorities under the cooperative federalism framework of section 401.

EPA agrees with the commenter who asserted that the proposed approach would allow
certifying authorities to consider information unrelated to CWA section 404. CWA section
401 applies to any Federal license or permit that may result in any discharge into waters of
the United States, which includes but is not limited to CWA section 404 permits. However,
the Agency disagrees that this would lead to a more burdensome request process. Under the
final rule, project proponents are required to provide a request for certification that, at a
minimum, includes a copy of the license or permit application and any readily available
water quality-related materials that informed the development of the application. This
information should not require any additional, independent development by the project
proponent since it includes information the project proponent has already developed for the
license or permit application process. Certifying authorities are allowed to define additional
contents in a request for certification, subject to several guardrails, as discussed further
below. The Agency anticipates that these guardrails will prevent a more burdensome
process because they ensure the additional contents are predictable and limited to water
quality-related impacts, as discussed in more detail below.

EPA also disagrees with commenters asserting that EPA is inviting certifying authorities to
engage in the types of practices that were rejected by the Second Circuit in NYSDEC. In
NYSDEC, the Second Circuit never addressed the separate question of whether EPA or
certifying authorities have the underlying authority to establish—in advance of receiving a

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request for certification—a list of required contents for such a request. Accordingly, the
court's holding that the reasonable period of time begins after "receipt" does not preclude
the Agency from establishing such a list of minimum "request for certification"
requirements, or from allowing certifying authorities to add requirements to EPA's list or
develop their own lists of request requirements. Because the statute does not expressly
define the term "request for certification," EPA and other certifying authorities are free to
do so in a reasonable manner that establishes—in advance of receiving the request—a
discernable and predictable set of requirements for a request for certification that starts the
reasonable period of time. The Agency knows of no legal authority that has squarely
considered this issue of a state or Tribe's underlying authority to identify requirements for
a request for certification and come to the opposite conclusion. The Agency decides,
consistent with principles of cooperative federalism enshrined in the Act, to continue this
lawful, familiar, and time-tested practice.

In response to commenters who discussed concerns over certifying authorities using the
proposed approach to define requirements that are overly broad, vague, and/or
unavailable, the Agency acknowledges these concerns and has incorporated reasonable
changes in the final rule that it anticipates impose sufficient guardrails to prevent those
practices, while also allowing certifying authorities to act on a request for certification in a
timely and informed manner. First, EPA added text at final rule section 121.5(c) that such
additional contents are "relevant to the water quality-related impacts from the activity,"
consistent with the scope of this final rule. EPA finds that contents of requests for
certification that are substantively beyond the scope of water quality-related impacts cannot
be reasonably necessary to make an informed decision regarding the potential water
quality-related impacts from the activity, and thus would not be in conformity with the
regulation. Second, section 121.5(c) itself limits the ability of a certifying authority to
request materials to those "identified prior to when the request for certification is made."
Although the Agency is allowing states and authorized Tribes to define their own additional
requirements for a request for certification, the rule provides a backstop for those states or
authorized Tribes that either do not identify those additional requirements prior to when
the request for certification is made or change their requirements after the request for
certification is made. In other words, certifying authorities cannot subsequently modify or
add to the required contents of a request for certification after the request was submitted.
This does not mean a certifying authority could not ask for additional information after a
request for certification is made; rather, a certifying authority cannot alter the required
contents of a request for certification after it is received. Indeed, the Agency finds this
approach creates a bright line for project proponents seeking to avoid unexpected shifts and
identify the necessary contents for a request for certification with certainty. Some certifying
authorities rely on a "complete application" to start the certification review process. In the
Agency's view, a state requirement for submittal of a complete application, when the
contents of such complete application are clearly identified ahead of time, is not inherently
subjective and can be defined by the information requested by regulation or on a form.
Establishing such a list of required elements in advance is consistent with the rationale of

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NYSDEC that criticized the state for relying on its "subjective" determination following
submission regarding whether the request was "complete."

The Agency expects that those states and authorized Tribes that choose to identify
additional contents in a request for certification will do so clearly enough to provide project
proponents with full transparency as to what is required. Relatedly, to remain consistent
with legal precedent, states and authorized Tribes should avoid non-exhaustive or vague
lists that a certifying authority could continually deem incomplete. When developing their
lists of additional contents in a request for certification, EPA recommends that other
certifying states and authorized Tribes look to section 121.5(b) for the list of contents EPA
has outlined for requests for certification when it acts as a certifying authority as a guide to
help the certifying state or authorized Tribe develop its own list. Although one commenter
suggested that EPA establish guidelines around what is a complete application, the Agency
finds such guidelines unnecessary in light of the expectations for additional components
discussed above and in the final rule preamble.

EPA disagrees with the commenters who asserted that the Agency's proposed approach to
the additional contents in a request for certification was arbitrary and capricious and
disagrees that the ability to request additional information either obviates the need to define
additional contents in a request for certification or reduces the risk for more denials under
the 2020 Rule. First, as discussed above, the Agency finds its approach in this final rule best
effectuates Congress' goals and directives for section 401 in the limited amount of time
provided by the Act. Second, as discussed in section 3.1.1, commenters identified several
challenges with the 2020 Rule's approach to the request for certification, which further
justifies and supports the Agency's approach in this final rule. While the commenter is
correct that nothing in the 2020 Rule prevented a certifying authority from requesting more
information during the reasonable period of time, that is not tantamount to requiring such
information in a request for certification. Indeed, under both the 2020 Rule and this final
rule, a project proponent is only required to provide the contents defined in a request for
certification to start the reasonable period of time. While it may be in the project
proponent's best interest to provide such information, neither the 2020 Rule nor this final
rule compel the project proponent to provide additional information requested after the
reasonable period of time begins.

The Agency acknowledges that its approach at section 121.5 may result in different
requirements for a request for certification across jurisdictions. However, as discussed
above, defining an exclusive list of contents would frustrate the intent of the Act's emphasis
on cooperative federalism and lead to procedural inefficiencies. See discussion above. The
Agency disagrees that this approach would place undue burdens on project proponents.
Rather, this approach should be familiar to project proponents who followed specific
requirements established by states and Tribes during the last approximately 50 years. The
Agency's final approach will allow for a transparent and timely process that respects the
role of state and Tribal certifying authorities under the cooperative federalism framework
of section 401. In response to commenter assertions that the final rule's approach to the

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request for certification would somehow lead to "vetoes" of multi-state projects, the Agency
observes that section 401 explicitly authorizes certifying authorities to deny section 401
certification for projects that will not comply with water quality requirements. These
commenters fail to explain how the contents of a request for certification would increase the
likelihood of this clear statutory outcome for multi-state jurisdiction projects. In fact, the
Agency finds that providing states and authorized Tribes with the ability to define
additional contents of a request for certification should ultimately reduce the need for
certifying authorities to request additional information from project proponents after the
request for certification has been submitted. In turn, this could allow for a more efficient
certification process that would benefit all projects, both those in one jurisdiction and those
that span across multiple jurisdictions. The Agency recommends that project proponents,
certifying authorities, and Federal agencies work together to determine the most efficient
and effective means of communication before the certification process begins to ensure a
common understanding of the contents of a request for certification.

EPA disagrees with the commenter suggestion that EPA should establish a lead agency to
oversee if the final rule's approach to additional contents of a request for certification is
working. EPA finds that the guardrails placed on a certifying authority that wishes to
define additional contents in a request for certification (as discussed above) are sufficient to
ensure an efficient and transparent process consistent with section 401.

EPA declines to adopt the recommendation from one commenter that the final rule should
require states and Tribes to alter their request for certification requirements to match the
Federal agency. As discussed above, the Agency reads the term "request for certification" in
a way that best effectuates Congress' goals and directives for section 401 in the limited
amount of time provided by the Act. The Agency does not find that the commenter's
suggestion is necessary to meet that objective. However, EPA observes that this final rule
does not preclude certifying authorities from coordinating with Federal agencies to
determine if there are similar or identical information needs. For example, if the Federal
license or permit application typically contains certain water quality information that the
state or Tribe intends to rely upon to act on the request for certification, the certifying
authority may not need to include such information in its additional contents because the
application will already be included in the request for certification for an individual license
or permit under this final rule. EPA encourages certifying authorities to determine to what
extent the minimum contents for requests for certification cover the potential information
needs they may have in analyzing a request for certification. This could obviate, or reduce,
the need to define or extent of additional contents (because they would already be included
with the application).

The Agency also disagrees with the commenter who asserted that states and Tribes should
rely on other laws or regulations to ensure Federal approvals subject to section 401 are
reviewed. Section 401 authorizes certifying authorities to certify or deny any federally
licensed or permitted activity that may result in any discharge into waters of the United
States. Nowhere in section 401 did Congress suggest that section 401 review should be

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supplanted or displaced by reviews pursuant to other laws or regulations. In fact, such a
result could lead to redundant review efforts that slow down, rather than speed up, the
Federal licensing or permitting process.

3.1.5 EPA Defining the Minimum Components, Including Additional Components Where a
Certifying Authority Does Not Define Additional Components

3.1.5.1 Support Proposed Default List of Contents

Some commenters supported EPA's inclusion of minimum certification request requirements for all
certifying authorities and argued that it would provide predictability and transparency for stakeholders.
Several of these commenters expressed support for this minimum list of requirements and the flexibility
for certifying authorities to define other components. A few commenters recommended that EPA extend
the minimum requirements proposed at section 121.5(c) to all requests for certification, and one of these
commenters recommended adding a sixth element that requires project proponents to "include
information that addresses all applicable project-specific information required by the certifying authority
to ensure compliance with water quality requirements under 40 CFR §121. l(m)," and asserted that
certifying authorities would be required to develop clear guidance to describe the types of additional
information that would be required. Another commenter recommended that the Agency should revise
proposed section 121.5(a) to be clear that these are minimum requirements for a request for clarification.

A few commenters agreed that EPA's additional contents for a request for certification should be the
default if a certifying authority does not have such a list. One commenter recommended that EPA should
allow certifying authorities to determine whether a project proponent has satisfied the requirements
proposed at section 121.5(c) when it applies.

One commenter suggested that the minimum requirements for the request for certification should provide
the certifying authority with the information it needs to make a certification decision at the outset of the
reasonable period of time and asserted that the vast majority of delays in processing applications arise
from the failure of project proponents to provide the certifying authority with sufficient information to
evaluate the proposed project.

Agency's Response: EPA agrees with commenters that defining some minimum components
of a request for certification increases clarity and efficiency in the certification process.
Recognizing that some certifying authorities already have or will define additional
requirements for requests for certification they receive, EPA is only defining the minimum
contents for all requests for certification. EPA finds this approach best respects
longstanding state and Tribal processes familiar to stakeholders and enables states and
Tribes to determine their specific information needs. However, EPA is also finalizing
additional contents for requests for certification to EPA or states and Tribes that fail to
define such additional contents to provide stakeholders with greater certainty and
predictability in the certification process. The final rule establishes an approach that
provides efficiency for requests for certification, while staying consistent with cooperative
federalism principles and case law. See also the Agency's response to comments in Section

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3.1.4 for further discussion on certifying authority ability to define additional contents in a
request for certification.

In this final rule at section 121.5(b), EPA is finalizing a slightly different list of additional
contents in a request for certification than what was proposed that combines components
proposed and offered as alternatives in the preamble to the proposed rule, due to the
feedback received in the public comments and the removal of a draft Federal license or
permit from the minimum contents for all requests for certification. The final list of
additional contents for a request for certification when EPA is the certifying authority (or
when states or Tribes fail to define such additional contents) includes seven components
derived from the proposed approach and the alternative approach. See section 121.5(b); see
also the Agency's response to comments in Section 3.1.5.2.

This final rule does not create the presumption that the contents identified at section
121.5(b) will be sufficient for all scenarios and all certifying authorities. Rather, the Agency
is providing a list of minimum contents as a baseline and allowing state and Tribal
certifying authorities to define additional contents for each request for certification. As
discussed in Section IV.C.2 of the final rule preamble, the additional contents in section
121.5(b) would not apply where a certifying authority has established its own list of
requirements for a request for certification. However, EPA recommends that certifying
authorities wishing to establish their own lists of additional contents of requests for
certification consider the requirements outlined by the Agency in section 121.5(b), as these
contents reflect the additional information deemed necessary by EPA for the Agency to
initiate its analysis of a certification request on a Federal license or permit application.

In response to the commenter who recommended that the Agency should revise proposed
section 121.5(a) to be clear that these are minimum requirements for a request for
clarification, the Agency restructured section 121.5 to clarify which components are
required for all requests for certification versus which components depend on the certifying
authority.

In response to the commenter who recommended that EPA allow certifying authorities to
determine whether a project proponent has satisfied the requirements proposed at section
121.5(c), final rule section 121.6(a) provides that "the reasonable period of time begins on
the date that the certifying authority receives a request for certification, as defined in
[section] 121.5, in accordance with the certifying authority's applicable submission
procedures." This approach provides certifying authorities with a role in determining when
the clock starts (i.e., by defining additional contents of a request for certification and
applicable submission procedures), while also providing transparency and consistency
around the process for requesting certification and starting the reasonable period of time
for project proponents.

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3.1.5.2 Do Not Support Default List of Contents

Several commenters took issue with EPA defining the minimum contents of a request for certification. A
few commenters asserted that it is unnecessary for EPA to define what information the state or Tribe
needs to act on a certification application in a timely and informed manner, including one commenter who
noted that their state's certification request provision has allowed the state to make multiple informed and
timely certification decisions. Another commenter argued that the proposed section 121.5 does not ensure
a certifying authority has all the information it needs to address state water quality standards and
recommended that the final rule should allow certifying authorities to define this information to ensure
they have all necessary information to render a decision under applicable Federal and state law. Another
commenter asserted that EPA should not define minimum requirements for certifying authorities, aside
from EPA, and should not describe certifying authority's requirements as additional requirements. One
commenter asserted that EPA does not have the authority to set procedures to be followed by states in
reviewing requests for certification. Another commenter argued that the proposed minimum requirements
for a certification request contravenes EPA's stated intent to further cooperative federalism and asserted
that EPA failed to explain why the minimum requirements are essential to a certifying authority's request.
The commenter asserted that EPA conflated the information necessary for a request with the information
certifying authorities may request in their review. One commenter argued that a draft permit, alone, does
not provide all the information necessarily required for a certifying authority's review, noting that states
such as California and New York require other environmental review documents under their state
administrative procedures. The commenter suggested that EPA should require project proponents to
provide a complete application pursuant to state administrative procedures.

Several commenters expressed concern that EPA's default list of additional certification request
components was inadequate and did not capture all the items a state may need for its analysis. One
commenter expressed concern over the list because it would take time for states to go through the
rulemaking process and make their own additional requirements and asserted that under the 2020 Rule,
the reasonable period of time was too short to ensure certifying authorities could request additional
information. Another commenter expressed concern that EPA's default additional components create a
presumption that EPA's list is sufficient for a request for certification, even though the commenter asserts
that such an interpretation is misplaced and inconsistent with the structure and intent of section 401. The
commenter suggested that EPA should make it clear that states and Tribes have the authority to specify
the contents of certification requests. A different commenter stated that EPA should not define other
elements as minimum requirements and should instead set a maximum burden that certifying authorities
may place on project proponents. One commenter expressed concern that proposed section 121.5 did not
describe a process for requesting supplemental information.

Some commenters provided suggestions for the default additional contents. Another commenter
suggested that all requests should include a detailed analysis for stormwater and how the project design
will protect waters from stormwater pollution. The same commenter also suggested that requests for
CWA section 404 projects should include a detailed sampling and analysis plan to ensure contaminated
materials are properly disposed. Another commenter stated that state and Tribal regulations and public
statements have identified the types of information necessary for certification review and the request,
including: (1) information on all of the project's potential impacts to water quality, including effects on

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the water's chemical, physical, and biological integrity; (2) whether and to what extent the project might
involve multiple discharges into the same receiving waters that could have cumulative effects; (3)
methods of construction and operating procedures; (4) description of compensatory mitigation actions to
offset foreseen impacts; and (5) preconstruction monitoring or assessment data of resource condition. One
commenter suggested the following minimum requirements: (1) all discharges, including their volumes,
locations, potential to contain pollutants, and chemical, physical, and biological characteristics; (2) all
receiving waters, including their locations, classifications, designations, impairments, and maps
delineating such waters; (3) environmental impacts caused by the project as a whole; (4) cumulative
effects; (5) alternatives to the project and discharges; (6) a description of how the applicant will monitor
effects; and (7) a list of avoidance and mitigation practices as well as restoration/remediation plans.
Another commenter specified that EPA should require additional information on discharges including: (1)
designation of the waterway; (2) volume of the discharge; (3) how and to what extent the discharge might
impair the waterway and its existing designation; and (4) whether and to what extent the project might
result in more than one discharge in the same waterway that could have cumulative effects. A few
commenters provided detailed, lengthy lists of additional information that may be requested by certifying
authorities, including but not limited to various plans, photographs, field surveys, construction methods,
and maps. Another commenter asserted that a request should include the requirements for a complete
application that are at least as stringent as Federal agencies making similar determinations, such as the
Corps' requirements for complete CWA section 404 permit applications.

A few commenters recommended supplementing the default additional request components with the six
additional components listed in the preamble, and as suggested by one of these commenters, revising as
appropriate to address any duplication. While mostly agreeing with the six alternative additional
components EPA listed, a commenter provided the following edit to the sixth component to include
mitigation: "Any additional information to inform whether any discharge from the proposed activity will
comply with applicable water quality requirements such as, but not limited to, an appropriate mitigation
plan, demonstration of compliance with best management practices, etc." However, one commenter
asserted that the six alternative additional components would not provide sufficient information without a
draft license or permit. One commenter who supported the additional request components listed in the
preamble recommended modifying the sixth component to read "Any additional information to inform
whether any discharge from the proposed activity will comply with applicable water quality requirements
such as, but not limited to, an appropriate mitigation plan, demonstration of compliance with best
management practices, etc." The same commenter asserted that the list with this addition would be
sufficiently clear and transparent to stakeholders and ensure certifying authorities have the materials
necessary to make a decision.

One commenter asserted that EPA's default list of additional components was flawed because the more
detailed description of that information was limited to facts about discharges instead of the project
activity, such as "any additional information to inform whether any discharge from the proposed project
will comply with applicable water quality requirements." The same commenter suggested that EPA
should ensure the rule does not cause additional challenges for certifying authorities seeking information
to inform their analysis.

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One commenter recommended that the project proponent provide a copy of the draft permit application
and the draft permit, any existing and readily available data or information related to potential water
quality impacts from the proposed project, and a description of any methods and means proposed to
monitor the discharge and the equipment or measures planned to treat, control, or manage the discharge.

A few commenters did not find the additional requirements for the alternative approach to be necessary
because the information would already be included in the application or under current state requirements.
One of these commenters asserted that these requirements were not applicable to hydropower projects and
generally focused on dredge and fill projects. One of these commenters expressed confusion over whether
the additional requirements for the alternative approach applied to all requests for certification or just to
EPA. Another commenter who found the additional requirements for the alternative approach to be
unnecessary recommended that EPA only require the submission of a license or permit application and no
additional contents if the certifying authority has established its own definition of request for certification
in its own regulations.

Agency's Response: The Agency disagrees with commenters asserting that it is
unreasonable for the Agency to define minimal information needs for a request for
certification or that it contravenes cooperative federalism principles (some commenters said
"unnecessary" but the relevant inquiry is whether doing so is "reasonable," not whether it
is "necessary"). EPA finds that defining some minimum components of a request for
certification increases clarity and efficiency in the certification process. Recognizing that
some certifying authorities already have or will define additional requirements for requests
for certification they receive, EPA is only defining minimum contents for all requests for
certification. EPA finds this approach best respects longstanding state and Tribal processes
familiar to stakeholders and enables states and Tribes to determine their specific
information needs. EPA is also finalizing additional contents for requests for certification to
EPA or state and Tribes that fail to define such additional contents to provide stakeholders
with greater certainty and predictability in the certification process. The final rule
establishes an approach that provides efficiency for requests for certification, while staying
consistent with cooperative federalism principles and case law. Relatedly, EPA disagrees
with the commenter suggesting that the Agency should set a maximum burden that the
certifying authority may place on a project proponent, as opposed to defining a minimum
list of contents for a request for certification. EPA finds that such an approach would not
support the cooperative federalism principles that underlie the CWA and section 401. The
final rule approach promotes cooperative federalism while also providing a clear and
efficient certification process (i.e., clearly defined minimum contents for all requests for
certification and clearly defined additional contents for requests for certification in the
event a certifying authority fails to define any additional contents for a request for
certification prior to receiving a request).

EPA disagrees with commenters asserting that the minimum requirements and/or
additional components required when EPA is the certifying authority are not adequate. To
provide transparency and predictability, the final rule requires project proponents seeking
certification from a state or authorized Tribe that has not identified additional contents of a

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request for certification to submit the additional contents identified at section 121.5(b). See
section 121.5(d). However, this final rule does not create the presumption that the contents
identified at section 121.5(b) will be sufficient for all scenarios and all certifying authorities.
Rather, the Agency is providing a list of minimum contents as a baseline and allowing state
and Tribal certifying authorities to define additional contents for each request for
certification. As discussed in section IV.C.2 of the final rule preamble, the additional
contents in section 121.5(b) would not apply where a certifying authority has established its
own list of requirements for a request for certification. EPA recommends that certifying
authorities wishing to establish their own lists of additional contents of requests for
certification consider the requirements outlined by the Agency in section 121.5(b), as these
contents reflect the additional information deemed necessary by EPA for the Agency to
initiate its analysis of a certification request on a Federal license or permit application.

To be clear, this final rule does not preclude certifying authorities from asking for more
information after they receive a request for certification and the reasonable period of time
begins, if the certifying authority determines additional information would help inform its
decision-making on the request for certification. The Agency is not defining a process for
requesting additional information after the reasonable period of time begins. However,
these requests for additional information by a certifying authority should be targeted to
information relevant to the potential water quality-related impacts from the activity. EPA
also encourages certifying authorities and project proponents to discuss the necessary
information that must be part of the request for certification during the pre-filing meeting
process.

In response to the commenter who expressed concern over the time it would take for states
to develop additional contents through rulemaking, the Agency is no longer requiring a
state or authorized Tribe to define additional contents of a request for certification in
regulation. See the Agency's response to comments in section 3.1.4.

EPA does not agree with commenters asserting that the additional components were
unreasonable. While some commenters said doing so was unnecessary, as noted above, the
relevant inquiry is whether EPA's inclusion of the additional components is "reasonable,"
not whether it is "necessary". EPA anticipates that the list of additional required contents
at section 121.5(b) is appropriate for EPA as a certifying authority and as a default list for
those other certifying authorities that have not identified additional required contents for
requests for certification. EPA also does not intend for this list to be duplicative.
Accordingly, EPA has added text at final rule section 121.5(b) to clarify that a project
proponent only needs to provide the additional components where such components are not
already included in the minimal contents of a request for certification defined at section
121.5(a). For example, if a map or diagram of the proposed activity site is part of the
Federal license or permit application, the project proponent would not be required to
submit a second copy of the map or diagram.

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The Agency appreciates commenter suggestions regarding alternative components that
should be included in EPA's request for certification and in state or Tribal certifying
authority requests where the state or Tribe fails to define additional components for a
request for certification. EPA is finalizing a slightly different list of additional contents in a
request for certification than what was proposed that combines components proposed and
offered as alternatives in the preamble to the proposed rule, due to the feedback received in
the public comments and the removal of a draft Federal license or permit from the
minimum contents for all requests for certification. The Agency has revised the list of
additional contents to reduce duplication between the minimal contents of a request for
certification. Additionally, the Agency recognizes that some of the components listed at
section 121.5(b) may not be applicable if the project proponent is a Federal agency seeking
certification on the issuance of a general Federal license or permit. Accordingly, the Agency
has added regulatory text at section 121.5(b) to clarify that only the applicable additional
components need to be included in a request for certification to EPA. See Section IV.C.2.b
for further discussion on the additional components included at final rule section 121.5(b)
as well as those components that were not included in the final rule. Although the Agency
did not include all suggested additional contents in this final rule, certifying authorities are
free to define additional contents for their requests for certification. EPA has adjusted the
language in the final rule to increase flexibility for certifying authorities to define the
additional contents of a request for certification in regulation or another appropriate
manner, such as an official form used for requests for certification. Such additional contents
should be communicated clearly and transparently for project proponents to be aware of
before submitting a request for certification.

3.1.6 Other Requirements for a Request for Certification

One commenter expressed support for including "a list of all other Federal, interstate, Tribal, state,
territorial, or local agency authorizations required for the proposed activity and current status of each
authorization" in a request, noting that it is required under the 2020 Rule, would not be burdensome to
project proponents, and would allow certifying authorities and the public to provide constructive
comments on the request.

Another commenter expressed support for requiring requests for certification to contain identification of
the applicable Federal license or permit.

A couple of commenters suggested that EPA should clarify that the project proponent should sign a
request for certification to clarify who in proposed 40 CFR 121.5(a) should sign a request for
certification.

Agency's Response: Similar to the 2020 Rule, the Agency is finalizing the requirement that
the project proponent provide a list of other authorizations that are required for the
proposed activity and the current status of such authorizations. This requirement will allow
the Agency to assess how water quality impacts may be addressed through other Federal,
state, or local authorizations and potentially reduce redundancies or inconsistencies

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between the certified Federal license or permit and other authorizations. When the project
proponent is a Federal agency seeking certification, the Agency does not expect the Federal
agency to be able to produce such a list. Typically, when a Federal agency seeks
certification, it is seeking certification on general Federal licenses or permits that would be
used by future project applicants. Therefore, at the time of the request for certification, the
Federal agency is likely unable to provide any information on which authorizations, if any,
are required for such a future project.

Based on commenter recommendations, EPA is not finalizing the components of the
proposed list that are expected to be captured by the requirements in section 121.5(a), such
as the name and address of the project proponent, the project proponent's contact
information, and identification of the applicable Federal license or permit, including the
Federal license or permit type, project name, project identification number, and a point of
contact for the Federal agency. Although this type of background information was included
in the 1971 Rule and the 2020 Rule, this information is unnecessary and redundant to both
the Federal license or permit application and draft Federal license or permit.

The Agency appreciates commenter suggestions on how to increase clarity regarding the
request for certification. Consistent with section 401(a)(1), this final rule clearly requires
project proponents to obtain certification for any federally licensed or permitted activity
that may result in any discharge from a point source into waters of the United States. The
term "project proponent," which is defined at section 121.1(h), is meant to include the
applicant for a Federal license or permit, as well as any other entity that may seek
certification (e.g., agent of an applicant or a Federal agency, such as EPA when it is the
permitting authority for a NPDES permit). Accordingly, the project proponent is
responsible for providing a request for certification that complies with section 121.5,
including signing the request for certification.

3.2 Receipt of a Request for Certification

3.2.1 Proposed Definition of "Receipt"

3.2.1.1 Support for Proposed Definition of "Receipt"

Some commenters supported EPA's proposed definition of receipt, specifically that the certifying
authority and not the Federal agency is responsible for determining when a request for certification is
received, and that the reasonable period of time begins upon receipt of a request by the certifying
authority. Some commenters noted the proposed definition of receipt will ensure consistency between the
rule and existing state and Tribal laws, and it will also allow states and Tribes to define "request for
certification" in a manner that safeguards comprehensive state and Tribal review.

Some commenters asserted that due to the wide variety in the types of projects in need of certification, the
regulations should not dictate when the review clock starts. Rather, the commenters asserted that states
should determine when it starts, and when they have sufficient information to conduct a proper review,

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provided all reviews fall within the statutory one year limit. Similarly, another commenter said that the
process of obtaining the information needed is not entirely within the certifying authority's control, and
therefore, a one-size-fits-all approach is not appropriate. A few commenters noted that states and Tribes
are in the best position to identify when they have received a request for certification. Another commenter
said that the benefits to states and Tribes of ensuring an adequate certification request is significant,
because if states and Tribes do not have what they need to make certification decisions, they risk waiving
their certification authority if they spend time trying to gather information while the clock for certification
winds down. The same commenter noted that not having adequate information may lead to unnecessary
denials, where states or Tribes could be forced to deny a certification because it lacks adequate
information to make an informed certification decision. Another commenter stated that provisions
defining "receipt" and "request" are much more reasonable interpretations of section 401 than the position
taken in the 2020 Rule, because they seek to ensure that a certifying authority's time to review cannot
begin without an adequate application. One commenter concluded that interpreting section 401 such that
the clock starts to run after an applicant provides a set of materials to a certifying authority without regard
for the specific needs of the state, does not benefit anyone.

A commenter noted that the largest source of delay in the certification process stems from the project
proponent's failure to provide the certifying authority with requested information. The commenter stated
that ensuring that project proponents know, in advance, what a state or Tribe expects of them will help cut
down on delays, while also ensuring that states and Tribes are not put into an unjustifiable position of
having the clock begin to run without a baseline of necessary information. The commenter asserted that
clarity would also help to alleviate disputes between applicants and certifying authorities over what
information is necessary, as was the case with the proposed Constitution Pipeline project in New York
State. The commenter continued on to argue that had the company provided that information at the outset,
it could have minimized delay and possibly avoided New York State's denial of its application. See
Constitution Pipeline Co., v. N.Y. State Dep't ofEnv't Conservation, 868 F.3d 87 (2d Cir. 2017). Outside
of the example of Millennium Pipeline, the commenter asserted that it was not aware of any instance in
which a court held that a certifying authority caused undue delay by adopting an overly subjective
definition of when an application is "complete," or what elements must be provided for a certifying
authority to be in "receipt" of a request. Furthermore, the commenter argued that if there is any question
that the submission practice requirements the state or Tribe is adopting are too subjective or broad, they
may be challenged on their face in one proceeding, rather than application-by-application contests like the
one in Constitution.

Some commenters agreed with EPA's position that the U.S. District Court of Appeals for the Second
Circuit's decision in New York State Dep't ofEnvtl. Conservation v. FERC, 884 F.3d 450, 455 (2d Cir.
2018) does not preclude a certifying authority from establishing procedures for effective filing of a
certification request. One commenter noted that section 401 does not define "receipt."

Some commenters supported the "reasonable period of time" beginning when the certifying authority
receives what it considers a "complete" application. A few commenters noted that the Second Circuit was
not the only authority on this question and pointed to the Fourth Circuit's decision in AES Sparrows Point
LNG v. Wilson in support of the reasonable period of time beginning when the certifying authority deems
the application complete. 589 F.3d 721 (4th Cir. 2009). One of these commenters argued that Federal

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agencies have interpreted section 401 as requiring an administratively complete application to trigger the
waiver period and provided the example that the Corps' regulations require the district engineer to
determine "that the certifying agency has received a valid request for certification" before determining
whether waiver has occurred. 33 C.F.R. § 325.2(b)(l)(ii). The commenter offered the example that
historically, the Corps interpreted the requirement for a "valid" request to mean a request "made in
accordance with State laws" since "the state has the responsibility to determine if it has received a valid
request." Final Rule for Regulatory Programs of the Corps of Engineers, 51 Fed. Reg. 41,206, 41,211
(Nov. 13, 1986); see AES Sparrows Point LNG, 589 F.3d at 729-30 (upholding the Army Corps
requirement for a "valid," interpreted synonymously with "complete" application). One commenter,
discussing the Second Circuit case, asserted that it begged belief that Congress intended section 401
approvals to turn on incomplete—perhaps overwhelmingly incomplete—applications and that the
statutory one-year backstop to the "reasonable period of time" was added to ensure that "sheer inactivity
by the State.. .will not frustrate the Federal application"—not to prevent certifying authorities from
obtaining in good faith the information needed to process the request. H.R. Rep. No. 92-911, at 122
(1972). Similarly, another commenter argued that they did not understand how the Second Circuit
determined that denying certification on incomplete applications (instead of using a completeness
standard) would make the certification process more efficient, asserting that the certifying authority's
need for sufficient information should take precedence and citing AES Sparrows Point.

Another commenter noted that many states require a complete application to trigger public notice and
comment, see, e.g., N.Y. Environmental Conservation Law § 70-0109(2)(a), because a complete
application is necessary to give the public a meaningful opportunity for review. See, e.g., Ohio Valley
Envt'l Coalition v. U.S. Army Corps of Engineers, 674 F.Supp.2d 783, 800-02 (S.D.W.Va. 2010) (noting
that "[completion and public notice are inextricably linked"). The commenter concluded that only a
complete application should trigger the reasonable period of time, to ensure that states can fully and
lawfully exercise their authority under section 401.

One commenter described FERC's requirement for applicants to request water quality certification within
60 days of FERC's notice that it is ready to begin environmental analysis of the license application under
NEPA. The commenter asserted that such a deadline does not necessarily coincide with the applicant's or
the certifying authority's determination of when the record is sufficient enough for the purposes of a
certification decision.

Agency's Response: The statute provides that the reasonable period of time begins "after
receipt of such request." 33 U.S.C. 1341(a)(1). The statute does not define the term "receipt
of such request," nor does it define how a request for certification must be received by a
certifying authority. The Agency proposed to define "receipt" at section 121.l(k) to mean
"the date that a request for certification, as defined by the certifying authority, is
documented as received by a certifying authority in accordance with the certifying
authority's applicable submission procedures." The final rule merely simplifies the
proposed rule's approach to when the reasonable period of time begins by placing the
definition of receipt in section 121.6(a).

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EPA provides in the final rule at section 121.6(a) that "the reasonable period of time begins
on the date that the certifying authority receives a request for certification, as defined in
[section] 121.5, in accordance with the certifying authority's applicable submission
procedures." This approach provides certifying authorities with a role in determining when
the clock starts (i.e., by defining additional contents of a request for certification and
applicable submission procedures), while also providing transparency and consistency
around the process for requesting certification and starting the reasonable period of time
for project proponents. See also the Agency's Response to Comments in section 3.1.

The Agency recognizes that some certifying authorities rely on a "complete application" to
start the certification review process. In the Agency's view, a state requirement for
submittal of a complete application, when the contents of such complete application are
clearly identified ahead of time, is not inherently subjective and can be defined by the
information identified by regulation or on a form. Establishing such a list of required
elements in advance is consistent with the rationale of NYSDEC that criticized the state for
relying on its "subjective" determination following submission regarding whether the
request was "complete."

While acknowledging the ruling in NYSDEC, the Agency also recognizes, as commenters
above noted, that the Fourth Circuit ruled in support of the reasonable period of time
beginning when the certifying authority deems the application complete. AES Sparrows
Point LNG v. Wilson, 589 F.3d 721 (4th Cir. 2009). The final rule approach is consistent with
this decision in that regard, and not inconsistent with NYSDEC, as explained above.

In response to the commenter discussing FERC requirements for submission of a request
for certification, EPA is aware that the Corps and FERC have separate section 401
implementation regulations addressing their respective Federal licensing or permitting
programs. See e.g., 33 CFR 325.2 (water quality certification on section 404 permits); 18
CFR 4.34 (water quality certification on FERC hydropower licenses). EPA expects that
Federal agencies with existing section 401 implementing regulations will evaluate their
regulations and other guidance documents to ensure consistency with this final rule. See
also the Agency's Response to Comments in Section 3.1.

3.2.1.2 Do Not Support Proposed Definition of "Receipt"

Some commenters expressed concerned about EPA's proposed definition of receipt and asserted that
allowing the certifying authority to determine whether it has received a "complete request" for
certification would create variable standards for determining when the clock begins to run that could
result in a lack of consistency among authorities about when a request is considered complete and when
the reasonable period of time clock starts. Some commenters also argued this would cause significant
uncertainty for project timelines, resulting in construction delays and cost increases. A few commenters
expressed concern that the proposed definition would limit predictability and could allow certifying
authorities to use the requirement to delay the certification process. One of these commenters argued that
the value of having a timeline limitation would be unduly diluted if certifying authorities can consider

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requests for certification to be incomplete, even if they contain all the requirements found in proposed
section 121.5(c). The commenter recommended that the reasonable period of time should commence on
the date that the project proponent fulfills their obligation to provide the information required by proposed
section 121.5(c) to the certifying authority. A different commenter disagreed that the reasonable period of
time could not start until after the draft license or permit, noting that EPA provided no timeline for such
drafts or any assurance that other agencies will make draft licenses or permits available.

A few commenters asserted that the Agency should use the plain language meaning of receipt and remove
the ability of certifying authorities to define a request for certification. One of these commenters asserted
that the term "receipt" is unambiguous, and EPA's proposed definition contravened any commonsense
construal of the term "receipt" so that the term is "wholly divorced from the act of receiving and instead
refers to some indeterminable point after a certifying authority receives a certification request, reviews it,
documents that it was received, and transmits that confirmation of receipt to the project proponent and
federal agency." The commenter stated that FERC's longstanding position is that the reasonable period of
time begins when an application for water quality certification is actually filed with a state agency,
instead of the date when an application is accepted for filing in accordance with state law. See
Regulations Governing Submittal of Proposed Hydropower License Conditions and other Matters, Order
No. 533, FERC Stats. & Regs. | 30,932 at 30,345-46 (1991). The same commenter stated that while the
Agency is permitted to adopt a new policy position, it must give "a reasoned explanation ... for
disregarding facts and circumstances that underlay or were engendered by the prior policy," F. C. C. v. Fox
Television Stations, Inc., 556 U.S. at 515, and argued EPA has not done so. Another commenter asserted
that the value of having a timeline limitation would be unduly diluted and a "complete application"
threshold would allow certifying authorities to initiate inefficient, iterative request loops before the
reasonable period of time can begin.

Some commenters stated that section 401 identifies that the period for a certifying authority's section 401
review is initiated upon "receipt of such request" and that the U.S. Court of Appeals for the Second
Circuit recognized that by creating a "bright-line rule" that the "receipt" of a section 401 request is the
beginning of review. NYSDEC v. FERC, 884 F.3d at 455. Similarly, some commenters argued that EPA's
proposal to define the term "receipt" as "the date that a request for certification, as defined by the
certifying authority, is documented as received" is inconsistent with the section 401, as interpreted by the
courts, and opens the door to the practice that the Second Circuit rejected. A few commenters asserted
that the Second Circuit held that allowing states to determine when requests are "complete" could create a
"subjective standard" in violation of the bright line requirements of section 401. NYSDEC, 884 F.3d at
455-56.

One commenter argued that EPA's references to "completeness" determinations in other permitting
programs are misplaced, arguing that the Federal permitting agency interprets the sufficiency of a permit
application that it is legally required to act upon, whereas under Section 401, the certifying authority is
not tasked with issuing a permit, reviewing a permit application, or even responding at all. The
commenter argued that this review is not a permitting process and that certifying authorities do not need
to dictate the contents of a section 401 certification request to protect their opportunity for meaningful
review of proposed discharges.

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Some commenters noted that if an applicant fails to provide adequate information or does not provide
sufficient information during the section 401 review, the certifying authority can deny the request for
certification. Furthermore, a few commenters highlighted that mandatory pre-filing meeting requests can
identify any information needs and help ensure an adequate record for a certifying authority to conduct its
review.

Agency's Response: While not retaining a definition of "receipt" in the final rule, EPA
maintains that the reasonable period of time clock starts when the certifying authority has
received a request for certification, as defined in section 121.5 of the final rule, in
accordance with the certifying authority's applicable submission procedures. See 40 CFR
121.6(a). For reasons discussed in Section IV.C of the final rule preamble and throughout
this section of the Agency's Response to Comments, EPA disagrees with commenters
suggesting that the Agency remove the ability of certifying authorities to define a request
for certification and finds that the final rule preamble and the Agency's Response to
Comments document provide a reasoned explanation for the Agency's position.

EPA disagrees with commenter assertions that having the certifying authority determine
when it has received a request for certification will lead to certifying authorities subjectively
determining when a request for certification has or has not been submitted. Rather, this
final rule expressly rejects such practices by limiting requests for certification from state
and Tribal certifying authorities with additional required components to those that are
identified prior to when the request for certification is made. See 40 CFR 121.5(c). This does
not mean a certifying authority could not ask for additional information after a request for
certification is made; rather, a certifying authority cannot alter the required contents of the
request for certification after it is received.

The Agency strongly disagrees with the commenter asserting that the Agency's approach to
receipt refers to an indeterminable point after a certifying authority receives a certification
request, reviews it, documents that it was received, and transmits that confirmation of
receipt to the project proponent and Federal agency. On the contrary, this final rule clearly
defines the precise point in time when receipt occurs and the reasonable period of time
begins - when the certifying authority has received a request for certification, as defined in
section 121.5 of the final rule, in accordance with the certifying authority's applicable
submission procedures. To be clear, the reasonable period of time does not start with the
written confirmation from the certifying authority that it received a request for
certification. Rather, consistent with section 401(a)(1), it begins on the date that the project
proponent submitted the request for certification as defined in this final rule.

EPA also disagrees with commenter assertions that the final rule's approach to the request
for certification and receipt would cause timeline uncertainty, delays, or increase costs.
Under the final rule, project proponents are required to provide a request for certification
that, at a minimum, includes a copy of the license or permit application and any readily
available water quality-related materials that informed the development of the application
(for individual licenses and permits). This information should not require any additional,

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independent development by the project proponent since it includes information the project
proponent has already developed for the license or permit application process. Certifying
authorities are allowed to define additional contents in a request for certification, subject to
several guardrails, as discussed in Section IV.C.2 of the final rule preamble and section
3.1.4 in the Agency's Response to Comments. The Agency anticipates that these guardrails
will support a transparent and predictable certification process.

EPA also disagrees with commenters asserting that EPA is inviting certifying authorities to
engage in the types of practices that were rejected by the Second Circuit in NYSDEC. In
NYSDEC, the Second Circuit never addressed the separate question of whether EPA or
certifying authorities have the underlying authority to establish—in advance of receiving a
request for certification—a list of required contents for such a request. Accordingly, the
court's holding that the reasonable period of time begins after "receipt" does not preclude
the Agency from establishing such a list of minimum "request for certification"
requirements, or from allowing certifying authorities to add requirements to EPA's list or
develop their own lists of request requirements. Because the statute does not expressly
define the term "request for certification," EPA and other certifying authorities are free to
do so in a manner that establishes—in advance of receiving the request—a discernable and
predictable set of requirements for a request for certification that starts the reasonable
period of time. The Agency knows of no legal authority that has squarely considered this
issue of a state or Tribe's underlying authority to identify requirements for a request for
certification and come to the opposite conclusion. The Agency decides, consistent with
principles of cooperative federalism enshrined in the Act, to continue this lawful, familiar,
and time-tested practice.

The Agency also disagrees that the concept of "completeness" is inherently subjective. As
discussed in Section IV.C.2 of the final rule preamble, having the certifying authority
establish a list of additional required contents for a request for certification before receiving
a request for certification, and therefore determine when the request has been received, is
not at odds with the decision from the Second Circuit.

In response to the commenter asserting that references to "completeness" in the section 401
context are misplaced, the Agency finds that the commenter's efforts to distinguish
complete section 401 requests for certification from complete applications in a permitting
context are unpersuasive. Section 401 certification is predicated on receipt of an
"application for certification," also known as a "request for certification." See 33 U.S.C.
1341(a)(1). Relying on a "complete" application to start a process is not a novel concept, nor
is the use of a "completeness" standard for applications or similar documents a novel
concept in CWA implementing regulations. Both EPA and the Corps have developed
regulations setting out requirements for "completeness" or "complete applications" to
initiate the permitting process. See 40 CFR 122.21(e) (describing "completeness" for
NPDES applications); 33 CFR 325.1(d)(10) (describing when an application is deemed
"complete" for section 404 permits). Neither CWA section 402 nor section 404 uses the
word "complete" to modify the term "application" in the statute, yet the agencies have

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reasonably interpreted the term "application" in those contexts to allow for a
"completeness" concept that provides a clear and consistent framework for stakeholders
involved in the section 402 and 404 permitting processes. The Agency is unaware of
significant issues with the use of "complete applications" in either the section 402 or section
404 permitting processes or a concern that it has led to a "subjective standard." The Agency
is not compelled by the commenter's argument that because a certifying authority may
waive certification that somehow implies it should not receive a complete application or
define what a complete application entails. The Agency is unaware of any legal authority
making such a distinction.

While commenters are correct that a certifying authority may deny a request for
certification due to lack of information, commenters fail to explain how such authority
equates to or limits the ability of certifying authorities to define the contents of a request for
certification. As discussed in section 3.1.4.2 of this response to comments, the ability to
request additional information is not equivalent to requiring such information in a request
for certification. Indeed, under both the 2020 Rule and this final rule, a project proponent is
only required to provide the required contents defined in a request for certification to start
the reasonable period of time. While it may be in the project proponent's best interest to
provide such information (i.e., to avoid a denial), neither the 2020 Rule nor this final rule
compels the project proponent to provide additional information requested after the
reasonable period of time begins. Similarly, the Agency is equally uncompelled by other
commenters' assertions that the pre-filing meeting should replace or obviate the need for
certifying authorities to define the contents of a request for certification. While commenters
correctly observe that pre-filing meetings provide an opportunity for certifying authorities
to identify information needs, commenters incorrectly assume every request for
certification will be preceded by a pre-filing meeting. As discussed in Section IV.B of this
final rule, the pre-filing meeting request requirement may be waived by certifying
authorities.

In response to the commenter highlighting FERC's position on "receipt" for purposes of
section 401, the Agency notes that EPA, and not FERC, is the Federal agency tasked with
administering and interpretating the CWA, see 33 U.S.C. 1351(d), 1361(a), including section
401, see Ala. Rivers Alliance v. FERC, 325 F.3d 290, 296-97 (D.C. Cir. 2003); NYSDEC, 884
F.3d at 453, n.33.

See also the Agency's Response to Comments in Section 3.1.4, 3.2.1.1.

3.2.1.3 Alternative Definitions for "Receipt"

Several commenters provided suggested revisions to the definition of "receipt." A few commenters
requested that the term "receipt" be clearly defined and consistently referenced throughout the proposal.
One commenter recommended revising "receipt" to say "the date that a request for certification that
contains all the required elements described at 40 CFR §121.5, is documented as received by the
certifying authority" stating that it would provide the necessary clarity and regulatory certainty to project

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proponents, certifying authorities, and Federal permitting agencies on the certification process. One
commenter suggested adding a reference to receiving the draft Federal license or permit in the definition
for "receipt." Another commenter suggested revising "receipt" to read "receipt means the date that a
request for certification, as defined by the certifying authority, and in accordance with the certifying
authority's applicable submission procedures, as well as the draft Federal license/permit, is documented
as received by a certifying authority." One commenter recommended modifying the proposed definition
of "receipt" to remove the requirement that a request for certification be submitted in accordance with a
certifying authority's applicable submission procedures.

A few commenters suggested revising the definition of "receipt" to clearly state that the reasonable period
of time begins when a certifying authority receives a complete application. One of these commenters
asserted that such a modification would make clear that requests with missing information do not
determine the relevant date of receipt, and that the reasonable period of time does not begin until a
complete request for certification has been received by the certifying authority. The commenter also
emphasized that inclusion of the word "complete" in the definition would not run afoul of the Second
Circuit's opinion as the concept of "completeness" is not inherently subjective and can be defined by the
information requested by regulation or on a form. The commenter also asserted that in the event a project
proponent has information that it fails to provide at the time of request, then that should render the
previously determined "receipt" date invalid. Another commenter encouraged EPA to re-assert that the
reasonable period of time only begins after the certifying authority is satisfied that it has received the
information it needs, arguing that it will ensure that certifying authority resources are spent on projects
that are certain.

A few commenters asserted that the proposed definition of "receipt" will likely lead to request processing
conflicts or confusion and suggested removing ambiguity from the definitions.

Agency's Response: The Agency appreciates commenter suggestions on defining the term
"receipt." As noted in the Agency's Response to Comments in Section 3.2.1.1, the final rule
merely simplifies the proposed rule's approach to when the reasonable period of time
begins by placing the definition of receipt in section 121.6(a). EPA provides in the final rule
at section 121.6(a) that "the reasonable period of time begins on the date that the certifying
authority receives a request for certification, as defined in [section] 121.5, in accordance
with the certifying authority's applicable submission procedures." This approach provides
certifying authorities with a role in determining when the clock starts (i.e., by defining
additional contents of a request for certification and applicable submission procedures),
while also providing transparency and consistency around the process for requesting
certification and starting the reasonable period of time for project proponents. EPA finds
that placing the concept in section 121.6(a) should prevent stakeholder confusion and is
unaware of any reason this final language should lead to processing conflicts or confusion.
The Agency has also made revisions throughout the final rule regulatory text to refer to
"the date that the request for certification was received" when referring to when the
reasonable period of time begins, as opposed to using the term "receipt."

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The Agency declines to remove the term "applicable submission procedures" from the final
rule requirements for when a request for certification is received. Applicable submission
procedures describe the manner in which a certifying authority will accept a certification
request, e.g., through certified mail or electronically. The Agency understands that
certifying authorities may have different procedures for receiving certification requests
(e.g., receiving certification in different formats or requiring the payment of fees), and as
such is not limiting or defining a set of standard applicable submission procedures. The
certifying authority may provide these applicable submission procedures in regulations or
another appropriate manner, such as an official form used for requests for certification. In
whichever way the certifying authorities provide their procedures, EPA encourages
certifying authorities to communicate them transparently and publicly. EPA recommends
that the certifying authority and project proponent communicate with each other (e.g.,
during any pre-filing meeting engagement) to discuss submission procedures and contents
of the request for certification.

The Agency is also declining to add the word "complete" to section 121.6(a) because it is
unnecessary and redundant in the final rule text. Under the final rule and consistent with
section 401(a)(1), the reasonable period of time clock starts when the certifying authority
has received a request for certification, as defined in section 121.5 of the final rule, in
accordance with the certifying authority's applicable submission procedures. Accordingly,
if a request for certification does not contain all the components provided at section 121.5,
then the certifying authority has not received a request for certification. See also the
Agency's Response to Comments in 3.1.4.

3.2.2 Comments on Defining Applicable Submission Procedures

Some commenters argued that EPA should define applicable submission procedures for all certifying
authorities to prevent certifying authorities from subjectively deciding when a request is complete. A few
commenters said EPA should provide a well-defined, unambiguous set of submission requirements so
that project proponents, certifying authorities, and Federal agencies know what is required for a proper
certification request. A commenter specifically recommended that EPA require all certifying authorities
to publish their submission procedures on a website in an easily accessible and understandable format and
that submission procedures be universally applicable (i.e., procedures should not change depending on the
type of project for which a certificate is requested). One commenter recommended that EPA define
"applicable submission procedures" as "the submission procedures deemed appropriate by the certifying
authority," which the commenter stated EPA suggested in the proposal. The commenter interpreted the
term to mean the form(s), address(es), and method(s) that a project proponent must use to submit a
request for certification to the certifying authority.

A few commenters argued that EPA did not need to develop procedures for submitting requests to the
certifying authorities. One commenter asserted that it did not believe EPA had the authority to set the
procedures to be followed by states in reviewing water quality certification requests, but assuming EPA
does have some authority to impose administrative procedures, the commenter argued that the proposal
did not do enough to ensure that state agencies have sufficient information to make informed section 401

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certification decisions. A few commenters asserted it would be sufficient to make submittal requirements
publicly available as opposed to placing them in regulation.

Agency's Response: The Agency finds it unnecessary to define the term "applicable
submission procedures" in this final rule. As noted above, the relevant inquiry is whether
declining to do so is reasonable, i.e., not arbitrary and capricious, as opposed to whether
doing so is necessary or unnecessary. As discussed in Section IV.C.2 of the final rule
preamble, applicable submission procedures describe the manner in which a certifying
authority will accept a certification request, e.g., through certified mail or electronically.
The Agency understands that certifying authorities may have different procedures for
receiving certification requests (e.g., receiving certification in different formats or requiring
the payment of fees), and as such is not limiting or defining a set of standard applicable
submission procedures. The certifying authority may provide these applicable submission
procedures in regulations or another appropriate manner, such as an official form used for
requests for certification. In whichever way the certifying authorities provide their
procedures, EPA encourages certifying authorities to communicate them transparently and
publicly. EPA recommends that the certifying authority and project proponent
communicate with each other (e.g., during any pre-filing meeting engagement) to discuss
submission procedures and contents of the request for certification.

The Agency recommends that project proponents, certifying authorities, and Federal
agencies work together to determine the most efficient and effective means of
communication before the certification process begins to ensure a common understanding
of the contents of a request for certification. The final rule's pre-filing meeting process
provides an opportunity for such early engagement to identify and discuss the appropriate
request for certification requirements. EPA also recommends that certifying authorities
make their additional contents for requests for certification and applicable submission
procedures readily available and transparent to the regulated public. EPA also intends to
support certifying authority efforts to make the requests for certification requirements
transparent. For example, EPA could provide links to other certifying authorities' websites
on EPA's website or maintain an up-to-date list of points of contact to connect project
proponents with the appropriate certifying authority.

3.3 Timing of the Request for Certification

3.3.1 Timing of Request for Certification in Relation to the Federal Licensing or
Permitting Process

One commenter recommended that the project proponent be encouraged or required to submit to the
certifying authority a copy of the Federal permit application and the additional materials required by the
state at the same time or very soon after the Federal permit application is submitted to the Federal agency.
While the commenter supported the concept in the proposal that the draft Federal permit be submitted
with the certification request, the commenter stated that it would be beneficial for the certifying authority
to receive a copy of the Federal permit application and any other materials required by the state as early in

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the process as possible before the draft Federal permit is ready. The commenter asserted that this would
ensure in most cases that by the time that the draft Federal permit is submitted to the certifying authority
and the reasonable period of time begins, the state certifying agency will have already begun its review
and therefore will be in the best position to act within the reasonable period of time. Another commenter
expressed support of the clarity on timing provided in the proposal by requiring a request for certification
to include the draft Federal license or permit; however, the commenter also expressed concern that if the
certifying authority is not provided information about the project before the draft permit is developed and
certification is requested, it may not have sufficient time to review certification requests for detailed
projects.

One commenter argued that nothing in section 401 suggests that EPA is authorized to dictate when a
project proponent may or must request certification, and that the proposed rule's prohibition on requesting
certification until an unknown point in time exceeds EPA's authority. The commenter argued that the
only timing element of section 401 is for a certifying authority to act on a request within one year of
receipt.

Another commenter stated that the 2020 Rule's certification requirements were mistimed relative to the
Federal licensing or permitting process.

Agency's Response: See the Agency's Response to Comments in section 3.1.

Section 401 does not define the contents of a "request for certification" or specify at what
point in the Federal licensing or permitting process such a request must or may be
submitted to the certifying authority. The statutory text and the legislative history both
clearly provide that the reasonable period of time begins once a certifying authority receives
a "request for certification." EPA is the Federal agency tasked with administering and
interpretating the CWA, see 33 U.S.C. 1351(d), 1361(a), including section 401, see Ala.

Rivers Alliance v. FERC, 325 F.3d 290, 296-97 (D.C. Cir. 2003); NYSDEC, 884 F.3d at 453,
n.33. Accordingly, EPA is authorized to determine when the reasonable period of time
begins once a certifying authority receives a "request for certification." EPA's
determination supersedes any contrary position taken by a project proponent. For reasons
discussed in Section IV.C of the final rule preamble and throughout Section 3 of this
Response to Comments, the Agency's determination best effectuates Congress' goals and
directives for section 401 in the limited amount of time provided by the Act.

3.3.2 Timing of Certifying Authority Notification of the Date of Receipt of the Certification
Request

Some commenters supported the requirement for the certifying authority to send written confirmation of
receipt of a request for certification to the Federal agency. A few commenters suggested that states should
also communicate when they deem a certification application incomplete.

A few commenters argued that there should not be a specified timeframe for when the state must send
written confirmation to the project proponent and Federal agency of the date of receipt of the request for

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certification, with one of these commenters asserting that this should be determined by when the
information requirements are met. Another commenter asserted that to the extent that EPA contemplates
establishing any process or schedule for itself, when acting as the certifying authority, or for states and
Tribes that do not adopt their own regulations on this question, that the process or timeline must be
sufficiently flexible to allow for a reasonable back-and-forth with the applicant. The commenter further
asserted that EPA should not set overly firm, pre-ordained deadlines for such requests, for example, by
dictating that the certifying authority must complete all such follow-up within a particular number of days
after receipt of a request. At a minimum, if EPA does set such a hard deadline, the commenter argued that
it must allow for extensions where the certifying authority deems it necessary.

Conversely, few commenters recommended including a specific timeframe. One commenter suggested, as
an example, within 5 days of receipt. Another commenter asserted that EPA should mandate that
confirmation of receipt be in writing and must be sent within 15 business days of receipt. Another
commenter asserted that a timeframe is justified because the two agencies (the certifying authority and
Federal permitting agency) have only 30 days from receipt of the certification request to negotiate a
reasonable period of time. Another commenter argued if the certifying authority receives an incomplete
request for certification, and therefore is not in "receipt" of a request for certification, then the certifying
authority would not be required to send written confirmation of the date of receipt to the Federal agency
and project proponent, because receipt would not have occurred. The commenter recommended that EPA
clarify this requirement and add a provision to require the certifying authority to notify the project
proponent and Federal agency that the certifying authority is not in receipt of a request for certification
because the project proponent has submitted an incomplete request for certification. The commenter also
recommended that EPA specify that the certifying authority has 30 days to notify the project proponent
and Federal agency of whether or not the certifying authority is in receipt of a complete request for
certification.

One commenter recommended that a copy of the request for certification be provided to the Federal
agency along with this written confirmation, to ensure that the request for certification is consistent with
the permitting request made to the Federal agency. Another commenter recommended clarifying that the
written confirmation should be emailed to or filed with the Federal agency.

A few commenters did not support the proposed removal of the 2020 Rule requirement that the Federal
agency notify the certifying authority within 15 days of receiving notice from the project proponent of the
certification request of: the date of receipt of the certification request, the reasonable period of time, and
the date waiver will occur. One commenter, a certifying authority, asserted that this notice provides
confirmation to both entities on the timeframes at play, is successfully implemented by the commenter,
and should remain in the final rule.

Agency's Response: Once a certifying authority receives a request for certification, the
certifying authority must send written confirmation to the project proponent and the
Federal agency of the date that the request for certification was received. The Agency
proposed similar language at section 121.5(d). However, the Agency has moved this
provision to section 121.6(a) to better clarify that the reasonable period of time does not
start with the written confirmation from the certifying authority. Rather, consistent with

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section 401(a)(1), it begins on the date that the project proponent submitted the request for
certification. If a project proponent submits a request for certification that does not meet
the requirements of section 121.5 of this final rule, the Agency recommends that the
certifying authority promptly notify the project proponent that it did not submit a request
for certification in accordance with section 121.5 of this final rule. However, certifying
authorities and project proponents can avoid such outcomes by leveraging early
engagement opportunities (Le., pre-filing meetings) to ensure a common understanding of
the required contents of a request for certification.

EPA recognizes that the final rule no longer includes a strict period for negotiation on the
length of the reasonable period of time between the certifying authority and the Federal
agency at the start of the reasonable period of time, which means that the certifying
authority may not promptly notify the project proponent and the Federal agency that the
request for certification was received. Accordingly, the Agency is removing the regulatory
text located at section 121.6(b) in the 2020 Rule, which required the Federal agency to
communicate the date of receipt of the request for certification, the reasonable period of
time, and the date waiver will occur. Under this final rule, the certifying authority is
responsible for confirming the date of receipt of a request for certification with the project
proponent and Federal agency. However, the final rule approach will not lead to the same
level of confusion as the 2020 Rule requirement for the project proponent to submit the
request for certification concurrently to the certifying authority and the Federal agency.
Under the 2020 Rule, although the certifying authority was responsible for determining
whether a request was received, a project proponent could submit a deficient certification
request to the Federal agency and spur the Federal agency to communicate an inaccurate
date of receipt for the request. The final rule approach avoids this potential
miscommunication by relying on the certifying authority, rather than the project
proponent, to communicate the date of receipt of a request for certification with the project
proponent and Federal agency.

The Agency is declining to define the timing, contents, or manner of such written
confirmation confirming the date the request for certification was received. However, the
Agency encourages certifying authorities to use pre-filing meetings as an opportunity to
provide information on how to submit requests for certification (e.g., discuss procedural
requirements for submission of a request for certification) and the contents of a request for
certification to ensure a common understanding between project proponents, Federal
agencies, and certifying authorities. EPA encourages project proponents, certifying
authorities, and Federal agencies to work together to determine the most efficient and
effective means of communication, including the most efficient means of communicating if
and when the request for certification is received.

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3.4 General Comments on Request for Certification

3.4.1	Early Engagement, Generally

A few commenters discussed the importance of early engagement with project proponents when
discussing the request for certification. One of these commenters asserted that the certification request
process is dragged out because of insufficient early engagement by project proponents.

Agency's Response: EPA agrees that early engagement is important for an efficient and
successful certification process. The Agency recommends that project proponents,
certifying authorities, and Federal agencies work together to determine the most efficient
and effective means of communication before the certification process begins to ensure a
common understanding of the contents of a request for certification. The final rule's pre-
filing meeting process provides an opportunity for such early engagement to identify and
discuss the appropriate request for certification requirements.

3.4.2	Certification Without Requests

One commenter asserted that EPA should clarify that states may waive the requirements for the contents
of a certification request or may act in the absence of a formal request, such as when a project proponent
unilaterally withdraws a section 401 request in an attempt to avoid an adverse decision or when a project
proponent requires expedited review in an emergency situation.

Agency's Response: For purposes of section 401, EPA does not agree that a CWA section
401 certification can be issued in the absence of a project proponent requesting certification
for a Federal license or permit that may result in any discharge into waters of the United
States. See section IV.A in the final rule preamble for further discussion on when
certification is required. EPA is aware that in some instances, certifying authorities use
section 401 certifications as state permits under state law; however, this final rule does not
address such practices. Similarly, if the certifying authority never received a request for
certification or if the request for certification or Federal license or permit application was
withdrawn, then the certifying authority is no longer responsible for acting on the request
for certification because the pre-requisite "request" is absent. See section IV.D.2.C in the
final rule preamble regarding the Agency's position on the legality of the practice of
withdrawing and resubmitting requests for certification.

3.4.3	Definitions

A couple of commenters suggested deleting the proposed definition at 40 CFR 121.1(c) (definition of
"application"), because it does not appear useful for interpreting more substantive aspects of the rule.

One commenter recommended retaining the definition of "request for certification" currently found in
section 121.1, with minor modifications to accommodate other proposed rule changes. Another
commenter recommended including a definition for "request for certification" under 40 CFR 121.1

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because they believed the use of the term in the definition for "receipt" may cause confusion during
implementation. One commenter recommended adding a definition for "request for certification" that
states that it means a written, signed, and dated communication that satisfies the requirements of proposed
section 121.5(c).

A couple of commenters supported removing the definition of "certification request." One of these
commenters said that an improvement to removing the definition of "certification request" is to clarify
that a certifying authority is not allowed to stop or restart the clock by requesting additional information.

Agency's Response: The Agency has deleted the proposed definition of "application"
proposed at section 121.1(c). See Final Rule Preamble Section IV.K for further discussion.

The Agency is finalizing the removal of the definition of "certification request" located at
section 121.1(c) of the 2020 Rule and finalizing the incorporation of those same definitional
elements directly into section 121.5. The Agency finds that incorporating the definitional
elements into the relevant regulatory section for request for certification will provide
greater clarity about the contents of a request for certification. Instead of needing to refer to
multiple sections of the regulatory text, the final rule allows stakeholders to refer to one
section of the regulatory text.

3.4.4	Data and Examples

Several commenters provided descriptions of their section 401 certification process. All of these
commenters stated that they utilize a JPA process for state and Federal permits for proposed projects.
Another commenter stated that in 2020, they developed section 401 certification procedures that
identified items necessary for a "complete" application. The same commenter stated that determining
whether a section 401 certification is complete can take between one and two months but described how
an increase in the use of pre-filing meetings has resulted in an increase in first-pass application
completeness. Similarly, another commenter stated that they had requirements for a complete section 401
certification application, via the adoption of an Antidegradation Statement as part of its water quality
criteria, such as demonstration of no practical alternatives to degradation and demonstration of social or
economic necessity.

Agency's Response: The Agency appreciates commenter input regarding certification
processes. See section IV.C of the final rule preamble and the Agency's Response to
Comments in sections 3.1-3.3 for further discussion of the requirements for a request for
certification.

3.4.5	General Permits and Licenses

A few commenters requested clarification from EPA on the impact of this rule on general licenses or
permits. One commenter requested EPA confirm that project specific certifications can be provided under
a general permit or license.

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Agency's Response: First, with regards to project proponents seeking project-specific
certification to obtain authorization under a Corps general permit, project proponents must
submit the minimum contents defined at section 121.5(a)(1). For example, if a state or Tribe
denied certification on the issuance of a Corps general permit, then to obtain authorization
under that general permit, the project proponent would need to obtain a project-specific
certification or waiver from the state or Tribe. In those cases, the "application" part of the
request for certification may take the form of a NOI or a pre-construction notification
(PCN). Second, with regard to individual projects that do not involve an "application" or a
"license or permit" but still require certification, like Corps' civil works projects, the
Agency expects the project proponent will provide documents in lieu of the application that
are similar in nature, such as a "project study," when requesting certification. In both
instances, the Agency expects the final rule's approach should be familiar to stakeholders
who have previously sought certification on such Federal licenses or permits.

3.4.6 Who is the Certifying Authority

A few commenters requested EPA clarify the situations where distinct certifying authorities, such as a
state, EPA, or a Tribe, would be the certifying authority.

Agency's Response: Section 401 requires a project proponent to provide the Federal
licensing or permitting agency a certification from the state or authorized Tribe "in which
the discharge originates or will originate." 33 U.S.C. 1341(a)(1). Pursuant to section 401 of
the CWA, EPA acts as the certifying authority on behalf of states or Tribes that do not have
"authority to give such certification." 33 U.S.C. 1341(a)(1). Currently, EPA acts as the
certifying authority in two scenarios: (1) on behalf of Tribes without "treatment in a similar
manner as a state" (TAS) and (2) on lands of exclusive Federal jurisdiction in relevant
respects. See section IV.H in the final rule preamble for further discussion on EPA's roles
under Section 401. The Federal agency and project proponent may discuss any questions
regarding jurisdiction with the certifying authority, or as needed, EPA in its technical
assistance capacity under section 401(b).

3.5 Input Received on Prior Rulemakings

3.5.1 Input on the 2019 Proposed Rule

This sub-topic summarizes comments that were made on a previous proposed rulemaking and were
resubmitted by commenters in the docket for the 2022 proposed rule.

Several commenters asserted that the reasonable period of time should only be triggered by the receipt of
a complete application so that the certifying authority can meaningfully evaluate requests and make
informed decisions, including noting that at least one Federal agency requires such an approach.
Otherwise, these commenters asserted that states may be forced to act on a request before the public
notice process is complete or deny certification. One commenter noted that certifying authorities have
limited resources and the 2019 proposed rule gives applicants an incentive to submit an incomplete

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application and wait out the clock. Some commenters asserted that the 2019 proposed rule approach to the
contents of the request for certification does not provide sufficient information to properly review and
ensure compliance under section 401. One commenter argued that nothing in section 401 contemplates
that the waiver provision was intended to artificially limit the information a state could require from an
applicant so that the state can make an informed decision.

Several commenters asserted that the 2019 proposed rule would improperly intrude into the realm of state
administrative procedures by specifying the contents of a section 401 request and state determination,
notwithstanding whatever contrary procedural requirements states may have enacted, noting that several
states have outlined in their own regulations the information an applicant must submit in order to allow
for meaningful state review. Commenters also noted that section 401 requires states to establish, and
adhere to, procedures for public notice on all applications for certification, and that requiring a complete
application is necessary to provide public notice and obtain meaningful public comment.

One commenter asserted that the 2019 proposed rule's approach to a certification request conflicts with
the text of the CWA, Congressional intent, and case law, and represented a radical departure from the
Agency's longstanding position, citing the 1989 and 2010 guidance documents.

Conversely, other commenters asserted that the 2019 proposed rule approach to request for certification
provided an appropriate balance between the certifying authority's need for sufficient information to
evaluate the request and the permit applicant's ability to obtain and submit the information to initiate the
reasonable period of time for review and the review process, and would provide regulatory certainty,
clarity, and efficiency. These commenters argued section 401 does not specify that the reasonable period
of time applies only for "complete" applications, citing N. Y. State Dep 't of Envtl. Conservation v. FERC,
884 F.3d 450 (2d. Cir. 2018), and highlighted projects where states relied on a complete application to
delay starting the reasonable period of time.

One commenter asserted that project proponents should provide certifying authorities with the best
information reasonably available at the time the request is made, and requested that EPA clarify that the
project proponent does not need to identify each and every location and type of any discharge that may
result from a proposed project in a certification request. One commenter agreed that general permits
require a different definition for certification requests, because the Federal agency may not have the same
information available as a project proponent on an individually permitted project.

Commenters also requested that EPA clarify how additional information could be requested, including
one commenter who requested clarification that such additional information would not invalidate the
certification request or restart the clock. One commenter also discussed the scope of that additional
information and how the reasonable period of time could be extended in those instances.

Agency's Response: See the Agency's Response to Comments in Sections 3.1-3.3; see also

Section IV.C of the final rule preamble.

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3.5.2

Pre-proposal Input from 2021

This sub-topic summarizes input that was received prior to the 2022 proposed rule and was resubmitted
by commenters in the docket for the 2022 proposed rule.

Several stakeholders asserted that the reasonable period of time should not begin until the certifying
authority receives a complete application as defined by the certifying authority. One of these stakeholders
noted that several certifying authorities have regulations or guidance documents detailing the information
that certifying authorities need to act on a request for certification. A few stakeholders requested that EPA
provide certifying authorities with flexibility to identify or request additional information in a request for
certification, including the ability to amend or expand requirements for such information. One of these
stakeholders requested that EPA include requirements for a complete application that are at least as
stringent as Federal agencies making similar determinations.

Several stakeholders stated that EPA's longstanding position recognized a complete application started
the reasonable period of time, as well as case law in the Fourth Circuit. See AES Sparrows Point LNG,
LLC v. Wilson, 589 F.3d 721 (4th Cir. 2009). One of these stakeholders asserted that the Second Circuit
failed to consider the Fourth Circuit's conclusion that the waiver provision in section 401 was ambiguous.

Several stakeholders asserted that the 2020 Rule requires certifying authorities to act on incomplete
information, which one of the stakeholders noted EPA conceded that the request may not be enough for
states and Tribes to make a certification decision. One stakeholder reiterated EPA's finding from the 2020
Rule that incomplete applications are the most common reason for certification delays and cited an
example where a project proponent submitted an application for certification before it even identified a
preferred route for the pipeline. Another stakeholder stated that when operating pursuant to pre-2020 Rule
guidance, its state was able to issue the vast majority of certifications in under 60 days.

Several stakeholders discussed the consequences of acting on an incomplete request for certification. A
few stakeholders asserted that incomplete information impedes certifying authority ability to protect water
quality. These stakeholders also asserted that incomplete information could delay a project by forcing a
certifying authority to deny certification or take action inconsistent with state laws and end up in
litigation. Stakeholders also asserted that incomplete information would prevent certifying authorities
from complying the section 401 public notice and comment requirements and force a certifying authority
to act on an application before this public notice and comment process has concluded (or even
commenced).

Conversely, several other stakeholders asserted that the 2020 Rule defines "certification request"
appropriately, balancing the certifying authority's need for sufficient information to initiate a meaningful
review and the permit applicant's ability to obtain and submit additional information as it becomes
available. These stakeholders asserted that certifying authorities can request additional information if
needed to complete its review. One of these stakeholders argued that the 2020 Rule's definition
effectuates the time limits imposed by Congress and prevents certifying authorities from exceeding the
one year maximum time limitation and using section 401 to delay projects, citing the Northern Access
project as an example of such delays. The other stakeholder asserted that there is no rationale for a change

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and that revisions would be contrary to Congress' clear intent, implicate Due Process, and dramatically
hinder the permitting process. Another stakeholder stated that the 2020 Rule definition has increased
clarity and transparency with respect to the statutory review period in a manner that is supported by the
plain language of the Act and ensures the information is consistent with the scope of certification.

One of these stakeholders also asserted that the Federal agency, and not the certifying authority,
determines when the reasonable period of time begins, arguing that allowing the certifying authority to
decide what should be in a request for certification would be tantamount to determining whether a request
is compete and avoid the statutory one year limit. The stakeholder stated that EPA should clarify that a
request for certification only requires the best information reasonably available to the project proponent at
the time the request is made.

Agency's Response: See the Agency's Response to Comments in Sections 3.1-3.3; see also

Section IV.C of the final rule preamble.

4. Reasonable Period of Time (Section 121.6)

4.1 Who Sets the Reasonable Period of Time

4.1.1 General Support for Federal Agency and Certifying Authority Jointly Setting the
Reasonable Period of Time

Several commenters expressed general support for the proposed approach to the reasonable period of time
because it was more consistent with cooperative federalism principles and allowed for collaboration
between the certifying authority and Federal agency. One commenter asserted that because it is a
mutually agreed upon deadline, it will provide certainty to project proponents. Another commenter
asserted that the proposed approach would give certifying authorities more input and ensure a more
accurate reasonable period of time since certifying authorities best know the length of time it will take
them to review a request for certification. Similarly, another commenter noted that the process for setting
the reasonable period of time should allow for consideration of state and Tribal requirements for public
engagement and environmental review.

Commenters also expressed support for setting up MOAs between Federal agencies and certifying
authorities to establish the reasonable period of time, including one commenter who recommended that
certifying authorities should develop programmatic agreements with specific Federal agencies. Some
commenters supported the collaborative approach, while asserting the approach is not efficient or
predictable and encouraged MOAs for efficiency purposes, especially in such well-established permitting
processes as section 401 certifications for section 404 permits. One commenter stated that categorical
determinations would be a more efficient mechanism of determining reasonable periods of time. The
commenter noted that they collectively issue approximately 1,000 certifications per year, so negotiating
individual periods of time would be cumbersome. The commenter noted that categorical agreements
could consider factors such as project type, location and scale of proposed projects, nature of discharge,
potential need for additional study or evaluation of water quality effects, and the certifying authority's
administrative procedures and notice requirements. One commenter said that the regulatory text should
say that the Federal agency and certifying authority can establish the reasonable period of time on a

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categorical basis. Similarly, another commenter suggested that EPA should clarify that categorical
agreements, in addition to case-by-case agreements, are permissible, even if entered into prior to the date
of receipt of the request for certification.

Some commenters asserted that the Federal agency should not be able to declare a fixed reasonable period
of time. Several commenters disagreed with EPA's alternative to retain the 2020 Rule's approach, where
the Federal agency is solely responsible for determining the reasonable period of time, for all the reasons
that EPA laid out in the proposal to justify revising the 2020 Rule. Commenters were especially
concerned that Federal agencies lack the authority to impose a shorter requirement on certifying
authorities and stated that courts have found that Federal agencies do not have the authority to unilaterally
impose a shorter timeframe on certifying authorities.

Agency's Response: EPA agrees with the above comments that the joint agreement
approach promotes cooperative federalism and may increase certainty. Under this
approach, Federal agencies and certifying authorities can offer each other their expertise
relevant to determining what timeframe is reasonable. The Agency also recognizes that
coordinating the reasonable period of time for reviewing requests for certification requires
time and resources for Federal agencies and certifying authorities. Therefore, EPA
encourages the creation of MOAs between Federal agencies and certifying authorities as
appropriate to help reduce the need for determining the reasonable period of time on a
case-by-case basis for every request. In fact, the final rule clarifies that Federal agencies and
certifying authorities may set categorical reasonable periods of time through written
agreements - for example, based on certain types of Federal licenses or permits.

The approach taken in the 1971 and 2020 Rules (i.e., relying on the Federal agency to set
the reasonable period of time) is not compelled by the statutory text because CWA section
401(a)(1) is silent regarding who may or must determine the reasonable period of time. Nor
does the statute imply that the Federal agency is the only entity that may establish the
reasonable period of time. As such, and as described in Section IV.D.2 of the final rule
preamble, EPA finds that the best reading of the statute is to allow both entities - the
certifying authority and the Federal agency - to play a role in establishing the reasonable
period of time, and only include the EPA-derived default of six months if they cannot come
to an agreement.

The Agency appreciates commenter input on the alternative to retain the 2020 Rule's
approach to setting the reasonable period of time. As discussed in Section IV.D of the final
rule preamble, the Agency is finalizing the proposed approach that the Federal agency and
certifying authority may collaboratively set the reasonable period of time on a project-by-
project basis or categorical project type basis (e.g., through development of procedures
and/or agreements), provided that it does not exceed one year. 40 CFR 121.6(b).

Although the Agency is not listing factors that Federal agencies and certifying authorities
must consider when establishing the reasonable period of time that the certifying authority
has to act on the request for certification, Federal agencies and certifying authorities might

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consider factors such as project type, complexity, location, and scale; the certifying
authority's administrative procedures; other relevant timing considerations (e.g., Federal
license or permit deadlines; associated National Environmental Policy Act deadlines; and/or
anticipated timeframe for neighboring jurisdictions process);; and/or the potential for the
licensed or permitted activity to affect water quality.

4.1.2 Do Not Support Federal Agency and Certifying Authority Jointly Setting
"Reasonable Period of Time "

4.1.2.1 Certifying Authority Should Set the "Reasonable Period of Time" or be Elevated Over
the Federal Agency

Many commenters said that the reasonable period of time determination should be driven by or solely
made by the certifying authority. Some commenters said EPA should remain silent on the reasonable
period of time and allow certifying authorities to apply their own administrative procedures, as long as the
one-year statutory limit is not exceeded. One commenter said that certifying authorities could put the
timelines on their own webpages to have that information publicly accessible. Another commenter
expressed concern about the 60-day default and said that if an agreement is not reached between the
Federal agency and certifying authority, then the certifying authority should determine the reasonable
period of time. Another commenter argued that only certifying authorities know what timeframe is
reasonable for them to complete a certification request. The commenter cited the vast disparity in staffing
resources, need to accommodate public comment, and varying project complexities, noting that some
projects require up to a year for adequate consideration.

A few commenters recommended that the Federal agency should not be placed on the same or elevated
footing over the certifying authority when it comes to setting the reasonable period of time. One
commenter argued that Federal agencies are unqualified to have the final say on the "reasonable period of
time (not to exceed one year)" because they lack expertise regarding water quality as well as knowledge
regarding each individual certifying authority's procedures for implementing section 401 or general
workload at any given point in time. The commenter also asserted that Federal agencies also lack
knowledge regarding the information a certifying authority needs to make its decision, or the schedule on
which information gathering and studies (which may be restricted to certain seasons) can or should be
conducted. Rather, the commenter argued that the state or Tribe is more familiar with their water quality
requirements, their aquatic resources, potentially affected state or Tribal waters, and what review time is
needed based on project complexity and wetland impacts.

Several commenters discussed concerns over coordinating the reasonable period of time. Several
commenters, who did not support the default 60-day period to set the reasonable period of time, asserted
that the proposal assumes states will have all the necessary information to evaluate the proposed project's
impacts when the request is filed. One commenter stated that most certification requests in their
jurisdiction are for Army Corps permits spanning four districts, and that it can often be difficult to
coordinate on one timeframe. The commenter stated that the fixed timeframe leads to inconsistent
practices that leave the public without predicable public notice procedures on projects and asserted a need
for the flexibility to extend the default period of time. Another commenter critiqued both the 2020 Rule

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and the proposed rule, arguing that by adding two Federal agencies to all section 401 certifications, even
uncomplicated ones, the rules created complications, thereby lacking effectiveness, efficiency, or
predictability.

One commenter supported EPA's proposed approach to allow certifying authorities to create a reasonable
period of time on a project type basis because it would enable certifying authorities to create more
efficient and predictable conditions for clean energy projects and meet the Administration's climate goals.
The commenter also recommended that EPA should mention in the final rule preamble that it will create a
template MOA for certifying authorities that would shift presumptive reasonable period of time and call
for no further conditions for clean energy projects.

Agency's Response: EPA disagrees that the certifying authority should solely determine the
reasonable period of time or be elevated over the Federal agency in setting the reasonable
period of time. CWA section 401(a)(1) is silent regarding who may or must determine the
reasonable period of time. Nor does the statute imply that the Federal agency is the only
entity that may establish the reasonable period of time. As such, EPA finds that the best
reading of the statute is to allow both entities - the certifying authority and the Federal
agency - to play a role in establishing the reasonable period of time, and only include the
EPA-derived default of six months if they cannot come to an agreement. As stated above,
Federal agencies and certifying authorities may collaboratively set the reasonable period of
time in lieu of relying on the default of six months. Federal agencies and certifying
authorities can offer each other their expertise relevant to determining what timeframe is
reasonable. Federal agencies are in the best position to opine on timing in relation to their
Federal licensing or permitting process. Likewise, certifying authorities are in the best
position to determine how much time they need to evaluate potential water quality impacts
from federally licensed or permitted activities. Certifying authorities are also best
positioned to opine on the impacts of state or Tribal procedures governing the timing of
decisions with respect to environmental review and public participation requirements.

EPA disagrees with commenters who recommended that the Agency should be silent on the
setting of the reasonable period of time and allow certifying authorities to apply their own
administrative procedures. As discussed in Section IV.D.2 of the final rule preamble, EPA
finds that the best reading of the statute is to allow both entities - the certifying authority
and the Federal agency - to play a role in establishing the reasonable period of time, and
only include the EPA-derived default of six months if they cannot come to an agreement.

EPA recognizes that coordinating the reasonable period of time for reviewing requests for
certification requires time and resources for Federal agencies and certifying authorities.
Therefore, EPA encourages the creation of MOAs between Federal agencies and certifying
authorities as appropriate to help reduce the need for determining the reasonable period of
time on a case-by-case basis for every request. In response to commenters' concerns about
setting the reasonable period of time each time a request for certification is submitted, the
final rule clarifies that Federal agencies and certifying authorities may set categorical
reasonable periods of time through written agreements - for example, based on certain

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types of Federal licenses or permits. However, EPA declines to develop an MOA template
for certifying authorities as suggested by one commenter. While the Agency may provide
technical assistance pursuant to section 401(b) upon request by a Federal agency, project
proponent, or certifying authority, the Agency does not find it appropriate to develop an
MOA template. Federal agencies are in the best position to opine on timing in relation to
their Federal licensing or permitting process. Likewise, certifying authorities are in the best
position to determine how much time they need to evaluate potential water quality impacts
from federally licensed or permitted activities. Certifying authorities are also best
positioned to opine on the impacts of state or Tribal procedures governing the timing of
decisions with respect to environmental review and public participation requirements.
Accordingly, Federal agencies and certifying authorities are best suited to draw upon their
collective expertise to develop an MOA, as appropriate.

4.1.2.2 Federal Agency Should Set the "Reasonable Period of Time"

Some commenters stated that Federal agencies should determine the reasonable period of time. One
commenter said that because the D.C. Circuit recognized a division of authority between the Federal
agency and certifying authority and held that the lead Federal agency decides matters of waiver, this
inherently means the Federal agency should set the reasonable period of time.

Several commenters expressed concern that the proposed approach would cause instability or
inefficiencies for various reasons, including the fact that there could be different reasonable periods of
time because it is set on a case-by-case basis or may differ by certifying authority. One commenter argued
that allowing each certifying authority to set their own reasonable period of time would make
implementation less clear and consistent. As an example, the commenter asserted that a pipeline that
crossed multiple jurisdictions could be subject to vastly different review deadlines for the same project,
forcing projects to wait for the certifying authority with the most expansive reasonable period of time.
The commenter also asserted that this hypothetical would be particularly true if EPA finalized the
proposed approach to allow Tribes to obtain TAS for section 401.

A few commenters recommended that the Agency ensure that certification decisions are not unnecessarily
delayed, or timelines evaded through loopholes. One commenter noted that both EPA and the Corps have
determined that the period should generally be less than one year. The commenter stated that having a
Federal agency set it serves to minimize the arbitrary delays and bureaucratic gamesmanship that were at
the heart of some states' concerns and suggested that EPA should continue to have Federal agencies
establish it, as they have done for decades consistent with judicial and administrative precedent. See, e.g.,
Hoopa Valley Tribe v. FERC, 913 F.3d 1099, 1104 (D.C. Cir. 2019) ("Thus, while a full year is the
absolute maximum, it does not preclude a finding of waiver prior to the passage of a full year.");
Constitution Pipeline Company, LLC, 164 FERC P 61029 (F.E.R.C.), 2018 WL 3498274 (2018) ("[T]o
the extent that Congress left it to Federal licensing and permitting agencies, here the Commission, to
determine the reasonable period of time for action by a state certifying agency, bounded on the outside at
one year, we have concluded that a period up to one year is reasonable.").

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One commenter asserted that the proposed approach would leave project proponents unaware of what the
reasonable period of time is and whether there will be an extension. One commenter asserted that the
2020 Rule provided a safety valve so that Federal agencies could extend the reasonable period of time at
the request of the certifying authority or the project proponent. One commenter argued that certifying
authorities had sufficient time under the 2020 Rule.

Agency's Response: The Agency disagrees with commenters asserting that the Federal
agency should determine the reasonable period of time. Such an approach is not compelled
by the statutory text because CWA section 401(a)(1) is silent regarding who may or must
determine the reasonable period of time. Nor does the statute imply that the Federal agency
is the only entity that may establish the reasonable period of time. As such, and as described
in Section IV.D of the final rule preamble, EPA finds that the best reading of the statute is
to allow both entities - the certifying authority and the Federal agency - to play a role in
establishing the reasonable period of time, and only include the EPA-derived default of six
months if they cannot come to an agreement.

The Agency also disagrees with commenter assertions that a collaborative approach to
setting the reasonable period of time will lead to inefficiencies or delays or that having the
Federal agency alone set the default serves to minimize arbitrary delays and bureaucratic
gamesmanship because that approach leaves the certifying authority out of the reasonable
period of time decision-making process. In response to commenters' concerns about setting
the reasonable period of time each time a request for certification is submitted, EPA
anticipates that certifying authorities and Federal agencies will enter into categorical
agreements, which will minimize, if not eliminate, any potential arbitrariness and
bureaucratic gamesmanship. Additionally, written agreements between Federal agencies
and certifying authorities with categorical reasonable periods of time - for example, based
on certain types of Federal licenses or permits - would create efficiency while still taking
advantage of the knowledge of both parties for determining the time necessary for
reviewing the request for certification. In response to commenters concerned about
different reasonable periods of time for multi-jurisdictional projects, the Agency
recommends that project proponents, certifying authorities, and Federal agencies work
together to determine the most efficient and effective means of communication before the
certification process begins. The final rule's pre-filing meeting process provides an
opportunity for such early engagement to gather input from project proponents that may
help in setting the reasonable period of time. The Agency does not agree that, nor
understand how, a project proponent would be more likely to be subject to different
reasonable periods of time due to the final rule's new TAS provisions. As discussed in
Section IV.H of the final rule preamble, EPA acts as the certifying authority on behalf of
states or Tribes that do not have "authority to give such certification," which includes the
scenario where a Tribe does not have TAS for section 401. In that instance, EPA would act
as the certifying authority and would be responsible for collaborating with the Federal
agency to set the reasonable period of time.

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The Agency disagrees with the commenter asserting that relying on a collaborative
approach to setting the reasonable period of time will leave the project proponent unaware
of the reasonable period of time or any possible extensions. This final rule does not prevent
certifying authorities and Federal agencies from communicating with the project
proponent. Rather, this final rule encourages certifying authorities, project proponents, and
Federal agencies to coordinate and communicate throughout the certification process. See
previous paragraph and the preamble to the final rule.

The Agency disagrees with the commenter asserting that certifying authorities categorically
had enough time to act on requests for certification under the 2020 Rule. While the Agency
agrees with the commenter asserting that the 2020 Rule allowed Federal agencies to extend
the reasonable period of time, the Federal agency was not required to grant extension
requests under the 2020 Rule. See 40 CFR 121.6(d)(2) (2020). As a result, Federal agencies
sometimes denied those requests even in situations where the certifying authority said it was
not able to act within the established timeframe (e.g., where state public notice procedures
required more time than the regulatory reasonable period of time). For instance, one
commenter noted that its requests for extensions due to public notice procedures were
refused by the Corps for the 2020 Nationwide General Permits.

4.1.3 Length of Time to Negotiate the "Reasonable Period of Time "

Some commenters did not support the proposed 30-day negotiation period for Federal agencies and
certifying authorities to establish the reasonable period of time. One commenter said that the Federal
agency and certifying authority should have more than 30 days to negotiate a reasonable period of time.
In their case, the commenter stated that they have 30 days to determine whether their requests are
complete, which leaves no time to negotiate an agreement with the Federal agency. A different
commenter said that EPA should provide at least 60 days for the Federal agency and certifying authority
to agree on the reasonable period of time.

A few commenters said that any default period for review should not begin to run until after the
expiration of the 30-day negotiation period. Otherwise, the commenters asserted that certifying authorities
will be forced to either: 1) begin processing certifications assuming a 60-day default, or 2) expend limited
agency resources attempting to negotiate with Federal agencies while simultaneously processing
certification requests. The commenters argued that both options are likely to result in less efficient
decision-making. Another commenter observed that EPA acknowledges that "short reasonable periods of
time (e.g., 60 days) do not allow the state or tribe sufficient time" but in circumstances where the Federal
agency and certifying authority cannot agree, that is precisely the outcome that the proposal could
produce. The commenter asserted that EPA further compounds this problem by having half the default
period run concurrently with the time the certifying authority and Federal agency are working to establish
the review period. The commenter further asserted that engaging in negotiations with the Federal agency
requires a new and extra commitment of resources that is not contemplated in the statute and many
certifying authorities, particularly Tribal certifying authorities, have limited staff and will not be able to
simultaneously make meaningful progress on an application while negotiating with the Federal agency.
The commenter stated that adopting a longer default period does not mean that certifying authorities

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would always take the full time allotted to make their decision, but it would eliminate the potential for the
lack of agreement to give the certifying authorities a mere month to act on a project where substantially
more time is necessary.

Another commenter requested that the reasonable period of time be predictable and supported the default
of 60 days but requested that EPA eliminate the 30-day period for the Federal agency and the certifying
authority to agree on a reasonable period of time. Alternatively, the commenter asked that the joint
agreement between the Federal agency and the certifying authority be made in consultation with the
project proponent. The commenter asserted that these changes would allow for greater regulatory
predictability for project proponents and reduce any confusion between the parties. One commenter
asserted that an appeals process must always be available to states and Tribes separate from the
reasonable period of time and regardless of whether there is time left on the clock.

Agency's Response: In response to commenters' concerns, EPA is not finalizing a
timeframe for the negotiation between Federal agencies and certifying authorities -
especially because the final rule makes it clear that the certifying authority and Federal
agency may coordinate categorical agreements prior to the date that a request for
certification was received.

EPA disagrees that any joint agreement between the Federal agency and the certifying
authority must be made in consultation with the project proponent. Requiring project
proponent consultation in every case would add unnecessary across-the-board procedure
and coordination into the certification process. Additionally, considering the high annual
average number of requests for certification,2 and therefore project proponents, it is
unlikely it would reduce confusion or allow for regulatory predictability. Rather, instead of
relying on categorical reasonable periods of time (e.g., by project type, by Federal license or
permit type), certifying authorities and Federal agencies would have to consult on every
request for certification. However, EPA notes that certifying authorities and Federal
agencies are welcome to consult with project proponents if they wish. For example, early
engagement with the project proponent during any pre-filing meeting discussions could also
serve to receive input from project proponents that may help in setting the reasonable
period of time.

Regarding the comment on an appeals process, EPA disagrees that an appeals process is
needed for states and Tribes, since states and Tribes are the entities providing a
certification decision as well as having a role in the reasonable period of time determination.
States and Tribes may avail themselves to their own state or Tribal appeals processes as
appropriate, but this final rule does not create (nor does the Agency find it necessary to
create) an appeals process.

2 EPA estimates that the average annual number of certification requests is 1,947 requests per certifying
authority. See Supporting Statement for the ICR.

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4.2

Default Reasonable Period of Time

4.2.1	Support for 60-Day Default Reasonable Period of Time

Several commenters agreed that a 60-day review is a reasonable default time limit. One commenter
explained that while highly complex reviews can require up to one year, certifying authorities often
review many simpler projects in 30 days or less. Another commenter opined that EPA should establish a
default of 45 days, but in no event should it be longer than 60 days. Another commenter observed that
applicable state law already requires it to approve or deny the certification request within 60 days of
receipt of a complete application. Another commenter stated that this would encourage FERC to revise its
hydroelectric regulations accordingly. One commenter supported the collaborative process to set the
reasonable period of time and viewed the 60-day default as sensible and practical since it will help ensure
consistency and predictability for stakeholders. Another commenter supported the 60-day default so there
is a known deadline if the Federal agency and certifying authority fail to reach an agreement. Another
commenter said it was a marked improvement over the 2020 Rule. Another commenter urged EPA to
refrain from allowing for modifications to the 60-day default by Federal agencies or certifying authorities
because a uniform period provides the most clarity to project proponents and other stakeholders, and it
would allow project proponents to anticipate the timeline for how the certification process will align with
their project timeline.

Agency's Response: EPA agrees that some certifying authorities often review many simpler
projects in a short period of time, such as 30 or 60 days. EPA recognizes that a 60-day
reasonable period of time is being implemented for section 401 decisions for some licenses
and permits, including by EPA for draft NPDES permits and by the Corps. However, EPA
disagrees that 60 days as a default reasonable period of time for all projects is sensible and
practical for the reasons provided in the Agency's rationale in the final rule preamble
section IV.D.2, in addition to the many comments summarized below explaining why a 60-
day default for all projects is not sufficient. EPA agrees that a uniform period can provide
clarity to project proponents and other stakeholders, but EPA is convinced that any
uniform period should only be a default to allow the certifying authority and Federal
agency to determine, as appropriate, the review timeframe on an individual or categorical
basis. While this may reduce the ability of project proponents to anticipate the timeline for
the certification process, they will still have six months as a default guidepost, plus EPA
anticipates that certifying authorities and Federal agencies will enter into categorical
agreements that will allow project proponents to anticipate timelines for certification
processes. As explained in the final rule and preamble, the default reasonable period of time
would not apply if the Federal agency and certifying authority agree to a different time.

4.2.2	Qualified Support for 60-Day Default Reasonable Period of Time

A few commenters supported the 60-day default in certain instances. One commenter agreed that 60 days
is an appropriate default for most projects if no joint decision is reached, but that 60 days may be
insufficient to thoroughly review information for larger, more complex projects. Another commenter
agreed that there should be no more than a 30-day timeframe to determine the reasonable period of time,

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and if the agencies do not come to an agreement, the reasonable period of time should default to 60 days
or some other set timeframe(s) that considers the level of Federal agency permit, the certifying authority's
codified procedures, and the scope and potential impacts of the proposed project. Ideally, the commenter
noted that it would be included in regulation for certifying authorities and Federal agencies to jointly
develop reasonable periods of time for standard permits. Similarly, another commenter generally
supported a project-by-project approach to setting the reasonable period of time, with a 60-day default,
but recommended that EPA provide the specific criteria for Federal agencies to use in evaluating and
establishing longer periods of time, including the complexity of the proposed project, the potential for any
discharge, and the potential need for additional study or evaluation of water quality effects from the
discharge. One commenter asserted that 60 days is sufficient to certify and suggested adding another 30
days for final ruling if parties agree and an additional 60 days if a public hearing is requested. Another
commenter asserted that the one-year timeframe allotted for FERC certifications was too long when
submitting an amendment that would have minimal water quality impacts and positive safety
improvements.

Agency's Response: EPA agrees in part and disagrees in part with these comments. EPA
agrees that 60 days may be appropriate for some projects (e.g., certain CWA section 402
and 404 general and NWPs involving less complicated projects) and anticipates that
certifying authorities and Federal agencies will enter into categorical agreements to address
those scenarios. EPA agrees that Federal agencies and certifying authorities could establish
criteria to use in evaluating and establishing periods of time other than the default,
including the complexity of the proposed project, the potential for any discharge, and the
potential need for additional study or evaluation of water quality effects from the discharge.
However, EPA is deferring to the combined expertise of the Federal agencies and certifying
authorities for establishing the reasonable period of time and declining to define the criteria
that must be used in establishing the reasonable period of time.

EPA appreciates commenter concerns over the need to ensure meaningful opportunities to
engage in the certification process. EPA recognizes that public notice and comment
procedures are critical aspects of the CWA and section 401. See section IV.F in the final
rule preamble for further discussion of public notice procedures and section 401. With
respect to public notice and comment procedures that extend beyond the default reasonable
period of time, the Agency proposed and is finalizing a process to automatically extend the
reasonable period of time to accommodate those public notice and comment requirements.
See section IV.D.2.b in the final rule preamble. However, for the reasons commenters
mention and as discussed throughout this section of the Response to Comments, EPA has
decided to finalize a default reasonable period of time of six months.

In response to the commenter asserting that a one-year reasonable period of time was too
long for a certification on an amendment to a FERC license, EPA notes that Section
401(a)(1) provides that a certifying authority waives its ability to certify a Federal license or
permit if it does not act on a certification request within the reasonable period of time. 33
U.S.C. 1341(a)(1) ("If the State, interstate agency, or Administrator, as the case may be,
fails or refuses to act on a request for certification, within a reasonable period of time

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(which shall not exceed one year) after receipt of such request, the certification
requirements of this subsection shall be waived with respect to such Federal application.").
Other than specifying its outer bound (one year), the CWA does not define what length of
time is "reasonable." As discussed in Section IV.D of the final rule preamble and
throughout this section of the Response to Comments, Federal agencies and certifying
authorities may collaboratively set the reasonable period of time in lieu of relying on the
default of six months. However, if a Federal agency establishes a one-year reasonable period
of time in regulation, it would not be at odds with the final rule's language or intent.

Rather, in such a scenario (e.g., FERC regulations), it is unnecessary for the certifying
authority and Federal agency to negotiate an alternate reasonable period of time because
the Federal agency has already agreed to the maximum amount of time statutorily allowed,
and if the certifying authority determines that one year is too long, it may act on the request
for certification as early as it chooses.

4.2.3 Opposition to 60-day Default

Many commenters expressed concern about the default reasonable period of time and said 60 days was
not long enough for various reasons.

Agency's Response: For the final rule, EPA decided on six months as the default reasonable
period of time for several reasons that are covered in responses below. See also Section IV.D
of the final rule preamble.

4.2.3.1 Cooperative Federalism Concerns

Many commenters that opposed EPA's proposed 60 day default argued that it effectively gives the
Federal agencies veto power over a longer period if the Federal agency refuses to agree with the
certifying authority on a different time period. For example, one commenter argued that establishing the
default as 60 days in the absence of an agreement between the certifying authority and Federal agency
would improperly interfere with the certifying authority's exercise of its authority under section 401,
because it would give the Federal agency the power to unilaterally impose a 60-day time limitation on the
certifying authority's time to act or risk waiver. The commenter relied on City ofTacoma, Washington v.
FERC, 460 F.3d 53, 65 (D.C. Cir. 2006) to support their assertion. Commenters also argued that the
proposal promotes one-way collaboration, instead of promoting cooperative federalism, and asserted that
states and Tribes should have the final say in determining how long it will take for them to fulfill their
obligations and act on a project's application. Commenters noted that where a Federal agency is required
to obtain certification for its own actions, the agency would be disincentivized from reaching agreement
with the state on a period greater than 60 days.

Agency's Response: The Agency appreciates commenter concerns regarding cooperative
federalism and the proposed 60-day default reasonable period of time. As discussed in
Section IV.D of the final rule preamble, the Agency has decided to finalize a default
reasonable period of time of six months to best balance equities between the Federal agency
and certifying authority, which should address commenter concerns and promote

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cooperative federalism. Federal agencies and certifying authorities can offer different types
of relevant expertise for setting the reasonable period of time. The final rule default
provides both parties with ample time to negotiate the reasonable period of time and inform
its length based on their respective expertise but provides a default middle ground in the
event an agreement cannot be reached. Six months is exactly half of one year, which is the
statutory maximum for the reasonable period of time. If the Federal agency and certifying
authority cannot reach an agreement, it seems reasonable to designate half of the statutory
maximum as the default reasonable period of time as a middle ground to best balance
equities between the Federal agency and certifying authority. Six months should give the
Federal agency and certifying authority ample time to negotiate an alternate reasonable
period of time if they do not want to be subject to the six-month default. At the same time,
the six-month default establishes a reasonable time period for Federal agencies and
certifying authorities to follow if they cannot agree on a different time period.

4.2.3.2 Increase in Denials or Waivers due to 60-Day Default

Several commenters asserted that the 60-day default would cause certifying authorities to deny requests
for certification they might otherwise grant if given adequate review time (not to exceed 1 year), resulting
in less efficient, not more efficient, administrative proceedings. For example, one commenter noted that
Washington State receives about 400 requests for certification annually - each request is different and
carries unique implications that must be examined based on the specific characteristics of the water
bodies and proposed project and Federal permit in question. However, the commenter noted that some
requests for certification require more time than others because they are unusually complicated or the
project proponent fails to furnish significant information, in which case the reasonable period of time
needs to be set in ways that allow consideration of individual circumstances. One commenter asserted that
the Federal agency may take up to 30 days to negotiate with a potentially overwhelmed state or Tribal
authority and, in turn, the state or Tribal authority may be left with only 30 days to act on the request,
which could strap state and Tribal authorities and lead to a rushed process or unnecessary denials by
certifying authorities that are not left with enough time to consider the full range of project impacts.

A few commenters stated that the 60-day default may result in more waivers. One of these commenters
asserted that a waiver is a significant consequence, and that the rule should not encourage waivers due to
more restrictive deadlines not found in the statutory text. The commenter asserted that a waiver based on
the inability to take reasonable review time to review a complex project or consult with Tribes or fulfill
state/Tribal public notice requirements is a draconian result and not the result intended by the CWA. The
commenter recommended that if the current language stands, then EPA should establish an appeals
process because there is little to no reassurance that should a state or Tribe need more than 60 days to
review a project, involve the public, and write a decision that the state or Tribe will receive this time.

Agency's Response: The Agency appreciates these comments and recognizes that a 60-day
default reasonable period of time is not sufficient for reviewing requests for certification for
all project types, potentially leading some certifying authorities to deny or waive
certification. For this reason, and several other reasons discussed in section IV.D of the final
rule preamble, EPA is finalizing a default reasonable period of time of six months.

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Additionally, EPA does not find an appeals process for certifying authorities to appeal the
default reasonable period of time necessary, because 1) certifying authorities are involved in
the determination of the reasonable period of time, and 2) the final rule includes provisions
for automatic extensions of the reasonable period of time in certain scenarios. See 40 CFR
121.6 and Section IV.D of the final rule preamble.

4.2.3.3 Administrative Burden and Time to Sufficiently Review

Numerous commenters alleged that the 60-day default is too short for certifying authorities to accomplish
required tasks. Commenters said the default is restrictive, prohibits thoughtful review of certification
requests, and places undue burden on the states given public notice requirements (e.g., state requires a 30-
day public notice period, which would need to run after an initial 2-3 week period to assign and conduct
an initial review of the request, so by the end of the notice period, they would be up against the 60-day
period without having sufficient time to respond to comments and conduct a final review). The
commenters argued that the 60-day default simply does not allow adequate time to receive and review the
request, receive any additional information requested, publicly notice the draft certification, respond to
public comments, and issue the certification decision. One commenter observed that a 60-day default
review period is not feasible, based on the time necessary for reviewing the project for completeness, the
time allotted for public notice, and the time for reviewing the project activities for certification. Another
commenter stated that certifying authorities need more time to evaluate an application as they ask
questions and receive more materials to address information gaps. Another commenter said that the
proposed default reasonable period of time and approach unfairly prejudices states' and Tribes' ability to
review projects, and asserted that certifying authorities are best equipped, in light of their understanding
of their own procedures, resources, and applicable state or Tribal law, to determine the time necessary for
review.

One commenter explained that in most cases, defaulting to 60 days will not allow sufficient time for a
state or Tribe to (1) technically review the certification request; (2) prepare and publish public notice of
the request for public comment; (3) make necessary supporting application documents and data available
to the public; (4) provide the public with sufficient time to review the proposal and draft and submit
comments, noting that EPA should assume that the public needs at least 60 days to comment after a
public notice is issued by a state or Tribe. See, e.g., E.O. 12866, Regulatory Planning and Review, 58
Fed. Reg. 51735, 51740 (Oct. 4, 1993) ("[A]fford[ing] the public a meaningful opportunity to comment
on any proposed regulation ... in most cases should include a comment period of not less than 60 days.");
(5) review comments and input submitted by the public; and (6) fully consider and respond to public
comments, before (7) making a determination on the request and giving notice of the same to the project
proponent and the public.

Several commenters expressed concern that the 60-day default did not account for the administrative or
resource burden on certifying authorities or Federal agencies. One commenter expressed concern about
the 60-day default reasonable period of time, because certifying authorities had to increase their staff and
resources to meet the Corps 60-day deadline. This commenter also stated that the 2020 Rule caused an
increase in workload to process additional individual certifications. Another commenter observed that
EPA did not address the increased administrative burden of requiring the certifying authority and Federal

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agency to negotiate the reasonable time period, and any extension of that time period, for every request
for certification. The commenter asserted that FERC has previously expressed an unwillingness to engage
in case-by-case review of state procedures in the context of section 401 due in large part to the
administrative effort. A different commenter said the proposal was not based on an analysis of project
timelines or input from Tribes and states and would put an excessive burden on Tribal staff who already
have limited capacity and multiple responsibilities—particularly in comparison to well-resourced
corporate permit applicants. The commenter noted that while these timelines may be less convenient for
industry, they are vital to the protection of treaty resources and community, and are rooted in decades of
legal precedent, public process, and the best available science. A different commenter added that
certifying authorities should not be expected to request extensions on each certification.

A few of these commenters discussed specific workload challenges in specific jurisdictions. One
commenter, who runs its 401 water quality certification program with a 0.5 full-time employee (FTE)
position, noted that states with relatively small programs aim to be expeditious in delivering timely
certification decisions but occasionally struggle to accommodate fluctuating workloads, especially when
staff is on leave or multiple applications are received at once. Accordingly, the commenter recommended
that EPA should lengthen the default to account for issues that may arise in complex certifications.
Another commenter said that looking at an activity as a whole requires a significant amount of staff time
and coordination to evaluate, for example, pre and post conditions for stormwater runoff; potential
impacts to threatened and endangered species including temporary staging and timing of proposed
activities; assessment of the functions and values of the wetland; loss or impact from the activities; and
evaluation of impacts to fisheries and benthic habitat. The commenter noted that in their state, the
certifying authority must publish a notice of a decision on all 401 water quality certifications, leaving it
with 30 days to confirm request for certification components are present and sufficient, review request for
certification materials, create EA summary documents, coordinate with the project proponent and the
Federal agency, conduct administrative processing such as coordinate the notice of tentative
determination with vendors/appropriate newspapers and route the certification through the appropriate
chain of command for signature, respond to comments received during the comment period, and attend to
other items as needed. As a result, the commenter stated that 60 days is not a sufficient or reasonable
period of time for nearly all request for certification reviews.

One commenter said that there is no reason to arbitrarily shorten the timeline for certification reviews,
and recommended that EPA extend the default to give overstretched state and Tribal agencies sufficient
time to collect comments and consider all relevant factors when reviewing the impacts of federally-
licensed projects.

Some commenters specifically discussed their concerns with the 60-day default reasonable period of time
and meeting public notice and hearing requirements pursuant to section 401. One commenter noted that
many states have statutory public notice and comment obligations that could not be completed within 60
days. The commenter asserted that the proposal's provision for granting an automatic extension where the
state or Tribal public notice and comment process takes longer than the negotiated or default reasonable
period is good procedural practice but is not a justification for a too-short default time limit - an extension
should be exceptional, not routine. Another commenter stated that if a public hearing is requested during
the public notice period, the 60-day review period would not be met and ultimately limiting the period to

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60 days may hinder the public input process if a hearing is deemed necessary. A different commenter
opined that the proposal sets timeframes that unreasonably limit its ability to meet its required
administrative and public processes for water quality decisions, noting that the CWA clearly grants states
the responsibility and authority to develop reasonable public notice procedures. The commenter suggested
that EPA's rule should consider that states require time to meet established procedures for public notice,
asserting that the proposal's default would make it difficult, if not impossible, for the commenter to
comply with existing public notice and comment requirements, particularly with respect to complex
certification decisions. The commenter asserted that consistently meeting time limits imposed by the
proposal would result in noncompliance or would require amendment of state law and that this limited
review period would interfere with the ability of the commenter to meet its administrative processes and
may not provide opportunity for meaningful notice and comment. One commenter asserted that the 60-
day default and additional procedures to obtain extensions to comply with public notice and participation
requirements disregards certifying authorities' expertise in processing and reviewing applications for
certification, and it makes the review process more burdensome, increasing the difficulty for states and
Tribes to comply with their own procedures and state law requirements. The commenter noted that the
CWA requires states to provide public notice and encourages public hearings and that many states are
required to hold a public comment period ranging from 15 to 60 days. The commenter also asserted that
some states must also wait for completion of Federal or state environmental reviews required under
NEPA or similar state statutes before making determinations on applications. As an example, the
commenter discussed the section 401 review process in Virginia. The commenter noted that state law
establishes the following: interagency consultation, public notice and comment, and the certifying
authority's review period, which can vary based on whether the project requires additional public
hearings or public process (e.g., natural gas transmission pipelines larger than 36 inches in diameter).
Another commenter found the 60-day default inadequate for project review because it must issue a public
notice for 30 days, then may need to address comments and/or hold a public hearing. The commenter
noted that they may also request additional information from the project proponent within this period,
which may delay the public notice. As a result, the commenter asserted that 60 days is not an adequate
period in which to request and receive additional information, hold a 30-day public notice, address
comments, hold a public hearing, and respond to additional comments.

Some commenters observed that, while EPA acknowledged that some certifying authorities may have
public notice requirements and could provide written justification for the extension, this will almost
always be necessary and would be an undue burden on them as they would need to provide a written
notice for every certification request. The commenters also asserted that it was unclear why these factors
would not already have been considered during the 30-day negotiation between the Federal agency and
certifying authority.

Commenters implored EPA to keep "front of mind" as it completes this rulemaking process that it can be
easy when considering the "moving parts" of the section 401 certification process to focus only on the
regulatory dynamic between the involved state or Tribe and Federal agency. The commenters asserted
that they and other members of the public lean heavily upon section 401 to protect water resources and
communities from pollution, and it is imperative for EPA to prioritize the public's interests and rights as
it considers section 401 timeframes and processes, citing 33 U.S.C. 1251(e).

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Relatedly, other commenters also asserted that EPA should not assume that there is a sophisticated
environmental attorney or non-governmental organization (NGO) "at the ready" to assist communities
with navigating every section 401 certification process, as most of the time there is not. Commenters
argued that many communities, including rural, frontline environmental justice, and other underserved
communities, require sufficient time after a certification application is publicly noticed by a state or Tribe
to figure out how to participate, attempt to find technical and/or legal assistance (if it is available at all),
and ultimately participate in the certification process with whatever understanding, expertise, and
resources they can muster. Commenters implored the Agency to prioritize the public's rights and ability
to fully and fairly participate in protecting their waters and communities and suggested the Agency could
accomplish this by allowing states and Tribes to determine reasonable periods of time themselves, or by
increasing the default reasonable period of time for states and Tribes to act, will be vital in this regard.
Another commenter asserted that the proposal provides inadequate opportunity for public engagement,
particularly by historically marginalized communities or Tribes, noting that sixty days may be an
appropriate amount of time in some situations but is far too short to be the default. Similarly, one
commenter noted that a longer period may be necessary to ensure historically marginalized communities
or Tribes impacted by a project have the time necessary to research and comment on the possible impacts
on waters that they rely and depend upon. As a result, the commenter asserted that the default appears to
be inconsistent with the Administration's goal of advancing environmental justice.

Agency's Response: EPA agrees that a 60-day reasonable period of time is not sufficient for
reviewing all requests for certification of different types of projects, and for the reasons
discussed in the final rule preamble, the Agency is finalizing a longer default reasonable
period of time of six months. See Section IV.D of the final rule preamble.

See also the Agency's response to comments in Section 4.1 on who sets the reasonable
period of time and Section 4.4 on automatic extensions to the reasonable period of time.

4.2.3.4 Default Should Be One Year

Many commenters said the proposed 60-day default is contrary to the plain language and intent and
purpose of CWA section 401, under which states have one year to decide on a request for certification.
Commenters asserted that Congress did not authorize EPA to decide for a state what constitutes a
"reasonable time" to act below one year, and that EPA's regulations should not contravene the statute by
mandating action, or allowing the Federal agency to mandate action, in less than one year.

Commenters asserted that there were several foreseeable consequences of a 60-day default, including
more frequent extensions and requests for extensions, more conflict over required review information,
strain on limited state capacity, and greater post-decision conflict or litigation. As a result, commenters
suggested that the default should be one year because it is sufficient time for a certifying authority to act
and provides confidence in an endpoint to project proponents. Another commenter asserted that EPA's
proposed default sets the certifying authorities up to fail, at the expense of the environment and the
communities section 401 is meant to protect. The commenter recommended that EPA should revise the
rule to provide that a Federal agency may request the certifying authority act in less time than one year,
but the certifying authority must consent and in no event shall its refusal or failure to act in less than one

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year be the basis for a waiver determination. Commenters suggested that EPA revise the proposal to read:
"If the Federal agency and the certifying authority do not agree on the length of a reasonable period of
time within 30 days of receipt of a request for certification, the reasonable period of time shall be one
year." One commenter asserted that a project proponent should assume a certification decision will not
occur until the statutory maximum one year runs.

Commenters asserted that while certifying authorities can and often do routinely act on requests in less
than one year, particularly in contexts outside of complex Federal licensing proceedings for major
infrastructure projects, like hydropower projects and natural gas pipelines, that does not mean EPA should
assume 60 days is sufficient time for a certifying authority to act in all cases. Instead, the commenters
suggested that states and Federal agencies can establish MOAs with shorter categorical or standardized
time periods for routine permitting matters and more contextually sensitive criteria for common project
types. For novel, complicated, or controversial projects, commenters suggested that states and Federal
agencies can negotiate an appropriate review period based on the factors EPA suggests - project type,
complexity, location, and scale; the certifying authority's administrative procedures; and the potential for
the licensed or permitted activity to affect water quality - but absent an agreement, the state should be
able to avail itself of the maximum time provided under the statute.

Agency's Response: EPA disagrees with commenters asserting that the plain language of
section 401 provides for a one-year reasonable period of time in all instances. As discussed
in Section IV.D of the final rule preamble, section 401(a)(1) provides that the reasonable
period of time "shall not exceed one year," which means that the reasonable period of time
can be less than one year. If Congress meant for the reasonable period of time to be one
year in all cases, it would have simply written "shall be one year." But Congress did not do
that. For the reasonable period of time to "not exceed one year," it must either be less than
or equal to one year. Under the clear language of the statute, Congress envisioned a
scenario in which the reasonable period of time could be less than one year. For the reasons
explained in Section IV.D of the final rule preamble, EPA reasonably decided on six months
as the default, which is half of the maximum allowable time, substantially longer than the
proposed and often applied 60 days, and consistent with almost 50 years of implementation
under the 1971 Rule. Again, the default only applies where the Federal agency and
certifying authority cannot agree on another period of time, which EPA expects to be rare.
In sum, this approach is consistent with the plain text of CWA section 401 and the Agency's
longstanding implementation of that text under the 1971 Rule, which acknowledged that the
reasonable period of time may be less than one year and is generally considered to be six
months. See 40 CFR 121.16(b) (2019). Nevertheless, the Agency re-emphasizes that six
months is only the default, and that certifying authorities and Federal agencies may agree to
a reasonable period of time less than or equal to one year on a case-by-case or categorical
basis.

See also the Agency's Response to Comments in Section 4.1 for further discussion on setting
categorical reasonable periods of time.

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4.2.3.5 Default Should Be 90 Davs/120 Davs/180 Days

Many commenters claimed that a 60-day default is too short and should be longer, providing specific
suggestions including 90 days, 120 days, and 180 days, noting that 180 days is consistent with EPA's
guidance under the 1971 Rule. Commenters stated that EPA lacks data to justify moving all proj ects to 60
days, which does not account for required time expended in discussion with the Federal agency, the
required coordination and review of pertinent information and consultation with other affected state
agencies, and implementation of state administrative requirements governing public notice and comment.
One commenter referenced the proposed rule's economic analysis and said that most certification
decisions are issued in 60-90 days, while another commenter observed that the reasonable period of time
for general permits almost always needs to be longer than 60 days, because determining the potentially
affected parties and impacts of a general permit takes a significant amount of time.

Several commenters argued that Section 401 already limits the maximum amount of time a certifying
authority may take—one year. One commenter noted that the suggested default of 60 days does not
recognize that for complex projects—like liquefied natural gas (LNG) terminals or deepwater ports and
those that trigger the need for an EIS or multiple Federal permits—it may be insufficient. The commenter
expressed concern that the proposal would not incentivize the Federal agency to critically weigh the needs
of the certifying authority for more time, since the period defaults to a mere 30 additional days if no
agreement is reached after the first 30 days elapse. The commenter supported a longer default period—
e.g., four to six months - and suggested that the certifying authority receive an automatic extension of
time when it has been asked to certify complex projects (like those described above), and when the
project proponent fails to provide needed information to the certifying authority within the existing time
frame.

A few commenters discussed a six-month or 180-day default. One commenter asserted that the default
should be increased to a minimum of six months to allow the public adequate time for robust and
meaningful public participation, and for states and Tribes to have adequate time to carefully consider and
incorporate public input in their decision making. Another commenter also said that EPA should return to
the 1971 Rule language that provided that the reasonable period of time was generally considered to be
six months. A different commenter said that a 60-day default is unreasonably short, especially considering
that the reasonable period of time was generally considered six months for the past 50 years. Another
commenter suggested that if EPA defines "request for certification" to include something short of the
draft Federal permit or license, it should lengthen the default period to at least 180 days, preferably one
year.

Commenters said that any default longer than 60 days but shorter than one year should be subject to
modification by agreement or by a Federal agency's regulations. Commenters asserted that this would be
more consistent with prior EPA regulations and practice and more likely to give states sufficient time to
obtain and review necessary information from the applicant and complete their public notice and
comment process.

Agency's Response: EPA agrees that a default 60-day reasonable period of time does not

capture the length of time needed for all requests for certification, considering some

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projects are more complex and may require more coordination and information. For the
final rule, EPA decided on six months as the default reasonable period of time for several
reasons, as discussed in detail in Section IV.D of the final rule preamble. While the data on
the amount of time it takes certifying authorities to act on a request for certification is
limited, the data that is available from 14 certifying authorities shows that a six-month
default would cover the self-reported length of time those certifying authorities take to issue
a certification decision. See Final Rule Economic Analysis. Additionally, based on
comments received on the proposed rule, it seems that many, if not most, commenters
would support a six-month default reasonable period of time. However, the Agency re-
emphasizes that six months is only the default, and that certifying authorities and Federal
agencies may agree to a reasonable period of time less than or equal to one year on a case-
by-case or categorical basis.

The Agency disagrees that the reasonable period of time should be automatically extended
for complex projects or when the project proponent fails to provide needed information.
The final rule provides automatic extensions to accommodate public notice procedures or
due to force majeure events (including, but not limited to, government closure or natural
disasters). The Agency maintains that providing a limited list of scenarios that warrant
automatic extensions promotes efficiency and clarity, while providing some flexibility for
stakeholders when unforeseen circumstances arise. However, Federal agencies and
certifying authorities may agree to extend the reasonable period of time for any reason,
such as those mentioned by commenters, provided it does not exceed the statutory one-year
limit.

4.2.3.6 Any Federal Agency Default Greater Than 60 Days Should Apply

Several commenters argued that the final rule should clarify that if a Federal agency has a regulation or
guidance document establishing a longer period for a particular type of request, that regulation or
guidance document applies. For example, commenters noted that FERC has established by regulation that
the reasonable period of time for state review of section 401 requests for hydropower and natural gas
projects is one year. However, commenters stated that it is not clear whether such separate regulatory
requirements would apply under the proposal.

A commenter asserted that the one year default the FERC established provides clarity and consistency
and avoids dispute and possible litigation that could arise from disparate case-by-case determinations.
Therefore, the commenter proposed that the default be 60 days unless the Federal agency regulations
define a different reasonable period of time, provided it is not less than 60 days, which would allow
FERC to continue applying one year, per its regulations.

Agency's Response: EPA does not find that Federal agency defaults in regulation that are
less than one year can supersede the need for a certifying authority and Federal agency to
collaborate in setting the reasonable period of time. That said, if a Federal agency
establishes a one-year reasonable period of time in regulation, EPA finds that it would not
be at odds with the final rule's language or intent. Rather, in such a scenario (e.g., FERC

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regulations), it is unnecessary for the certifying authority and Federal agency to negotiate
an alternate reasonable period of time because the certifying authority is provided the
maximum amount of time statutorily allowed, and if it determines that one year is too long,
it may act on the request for certification as early as it chooses. In these circumstances,
individual written agreements for each request for certification communicating the
reasonable period of time would not be necessary, since a negotiation between the certifying
authority and Federal agency would not need to occur.

4.2.3.7	EPA's Experience with NPDES Permits is not Representative

Some commenters observed that EPA's primary support for the default is its "nearly 40 years of
experience with NPDES permits." But the commenters noted that, according to the economic analysis,
less than 0.05% of "the annual average number of Federal licenses or permits issued that may require
section 401 certification" are NPDES permits. Commenters also noted that the same document
acknowledges that "[m]ost states issue certification decisions [for all projects] in 60-90 days."
Accordingly, the commenter asserted that EPA cannot rely on its experience with NPDES permits—
which make up an infinitesimal amount of the number of potential 401 certifications required annually—
to prevent certifying authorities from taking the time necessary to fulfill their obligations under section
401.

Agency's Response: The Agency acknowledges that EPA-issued NPDES permits only
comprise approximately 0.25 percent of the annual average number of Federal licenses and
permits subject to certification. See Final Rule Economic Analysis. The Agency also
appreciates the variable factors that inform the amount of time it may take a certifying
authority to act on a request for certification. As discussed further in section IV.D of the
final rule preamble, the Agency is finalizing a six-month default reasonable period of time.

4.2.3.8	60 Days is Unreasonable if Draft License or Permit is not in the Request For Certification

Several commenters noted that, should the final rule not include the requirement for the applicant to
include in a request for certification a draft of the relevant Federal license or permit, a longer time for
review will be required, and the final rule should reflect this. Commenters asserted that EPA's adoption of
a shorter default period appears to be, in large part, predicated on the assumption that the "request" the
certifying authority will receive will include a draft Federal license or permit and thus it will have the
benefit of the process that the Federal agency has undergone and the preliminary conditions the agency
will seek to impose. Commenters noted that if EPA opts for a different approach that does not require that
applicants wait to apply until they have a draft Federal permit or license, the proposed default will be
unreasonable in an even greater number of cases.

Agency's Response: As discussed in Section IV.C of the final rule preamble, EPA is not
finalizing that a copy of the draft license or permit be included for all requests for
certification. The Agency agrees that 60 days is not sufficient for certifying authorities to
review all requests for certification due to different project types having varying levels of

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complexity. Therefore, EPA is not finalizing a 60-day default reasonable period of time. See
Section IV.C, D of the final rule preamble.

4.2.3.9	CZMA Federal Consistency Review

Several commenters asserted that the 60-day default reasonable period of time would not align with
concurrent Federal consistency reviews conducted pursuant to the CZMA and would either undermine
efficient review processes or make it unnecessarily challenging. One commenter noted that Federal
consistency review under the CZMA provides states with an important tool to manage coastal uses and
resources, to facilitate cooperation and coordination with Federal agencies, to work with non-Federal
entities seeking Federal approval and authorizations, and to balance competing interests such as energy
development, tourism, recreation, and ecological protection. Another commenter noted that multiple
coastal states have reported that, under the 2020 Rule, Corps districts have set 60- or 90-day time limits
for CWA section 404 permits and have had to routinely grant extensions. Most of these commenters
recommended that the timeframe should never be shorter than the CZMA Federal consistency period of
six months, particularly for activities in the coastal zone. One commenter suggested that EPA should also
ensure as a general principle that, should the design or impacts of a proposed project change significantly
during the review process, regardless of whether the changes are driven by preliminary Federal permit
conditions or any other reason, adequate time is provided to states to review the changes through
extension or staying of the review period. The commenter argued that it is beneficial for the Federal
agency and the applicant that these processes align as to reduce decision delays.

Agency's Response: While most of these comments are addressed through the establishment
of a longer default reasonable period of time of six months, EPA also notes that these are
the types of permits, licenses, and/or projects that could warrant a categorical agreement
between the Federal agency and certifying authority to establish the appropriate reasonable
period of time. Furthermore, as discussed in section IV.D of the final rule preamble, if a
Federal agency establishes a one-year reasonable period of time in regulation (e.g., FERC
regulations), it is unnecessary for the certifying authority and Federal agency to negotiate
because the certifying authority is already provided the maximum amount of time
statutorily allowed.

4.2.3.10	Complex Projects

A few commenters stated that 60-day default could be appropriate for smaller projects (e.g., projects
covered by general permits), but for complex projects the 60-day default may not provide certifying
authorities with enough time to determine a proposed project's compliance with applicable water quality
regulations. Commenters suggested that the final rule should consider the circumstances that impact the
amount of time a certifying authority may need to evaluate a proposed project to uphold the certifying
authority's role of restoring and maintaining the chemical, physical, and biological integrity of the
Nation's waters and defer to the expertise or management needs of the certifying authority when
establishing reasonable periods of time. Accordingly, commenters recommended that the final rule could
establish default durations as a function of permit type, noting that this approach considers that the
evaluation of a project requesting the use of a general permit, for example, may differ from the evaluation

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of a project requesting an individual permit with the understanding that in no instance will the period
exceed one year from the date of receipt of a certification request.

Another commenter asserted that water supply projects in their jurisdiction are often controversial and
generate a large volume and wide range of public comments, which can be very technical in nature as
local groups that oppose water projects hire consultants to conduct their own evaluations of project
impacts. The commenter stated that it takes public process seriously and is diligent in its efforts to
consider and incorporate, where appropriate, these comments into conditions. The commenter also noted
that it coordinates with certification applicants and other state agencies in crafting mitigating conditions ~
a process that entails a great deal of email communication and numerous meetings to discuss myriad
technical and legal aspects of certification conditions.

Several commenters observed that the 60-day default is inadequate for FERC pipeline authorizations or
relicensing of hydroelectric dams, for which FERC has established by regulation the reasonable period of
time as one year. Commenters asserted that hydropower projects are complex, time-intensive, and can
affect many miles of rivers with their operations and contain multiple dams and other project works that
impact water quality in the entire watershed. In many cases, commenters noted that certifying authorities
need a full year to entirely assess the impacts of a given hydropower project on water quality. Indeed, one
commenter's last four water supply projects that have undergone the certification process have taken the
entire year to process, even with several staff members, consultants, and an assigned attorney dedicating
significant resources consistently throughout that entire period of time.

Agency's Response: The Agency agrees that 60 days may be a sufficient reasonable period
of time for some projects, but other projects may require more time for certifying
authorities to act on the request for certification. For multiple reasons discussed in Section
IV.D.2 of the final rule preamble, EPA is finalizing a default reasonable period of time of six
months. The Agency is not finalizing different default reasonable periods of time based on
project types, because EPA does not believe it can draw clear lines on the needs of projects
even if they are for the same type of permit or project. Some projects of the same type may
require more or less time for review, and circumstances or questions that arise are not
always predictable. Rather than establish multiple default reasonable periods of time based
on project or permit type and risk confusion, EPA is finalizing a default reasonable period
of time that is in the middle of the statutory limit of one year. However, EPA reminds
stakeholders that the default of six months only applies if the certifying authority and
Federal agency do not reach an agreement. Federal agencies and certifying authorities may
collaboratively set the reasonable period of time in lieu of relying on the default of six
months. Under this approach, Federal agencies and certifying authorities can offer each
other their expertise relevant to determining what timeframe is reasonable. The Agency
also encourages certifying authorities and Federal agencies to consider project complexity
when determining the reasonable period of time.

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4.2.3.12 No Default

A few commenters suggested that the Agency should not establish a default reasonable period of time,
including one commenter who suggested that certifying authorities and Federal agencies have the
opportunity to decide on the default reasonable period of time instead of the 60-day default.

Agency's Response: EPA holds that establishing a default reasonable period of time in the
final rule provides transparency for all stakeholders in the certification process. A default
six-month reasonable period of time is consistent with the Agency's longstanding 1971
regulations, which provided that the reasonable period of time is generally considered to be
six months. See 40 CFR 121.16(b) (2019). Thus, EPA's decision to choose six months as the
default reasonable period of time is consistent with almost 50 years of program
implementation under EPA's 1971 regulations. See Section IV.D of the final rule preamble
for further discussion on the Agency's rationale for establishing a six-month default
reasonable period of time.

4.3 Causes for Delays and Data

A few commenters stated that a main cause of certification delay was insufficient application materials
provided by the project proponent. One commenter cited several examples of project proponents delaying
the process by: (1) choosing to withdraw and resubmit certification requests because they had not
previously complied with environmental regulations, (2) "persistently refusing] to provide information"
requested by the certifying authority, or (3) "walking away" from an extended timeframe agreement with
the certifying authority after the certification was later denied. This commenter asserted that applicants
have an incentive to delay the certification process to avoid more stringent certification conditions.
Another commenter stated that applications submitted before being finalized was the most common cause
of certification delays. Another commenter stated that for a proposed natural gas pipeline project, the
certifying authority requested additional information from the project proponent multiple times and never
received sufficient responses to allow the state to certify the project. This commenter also asserted that
the reasonable period of time should be extended in the event of an applicant-caused delay so that the
certifying authority is not forced to deny the certification request. Another commenter argued that
allowing certifying authority's discretion in allowing extensions and withdrawal and resubmission would
delay projects and make project proponents unsure of timing.

Some commenters provided quantitative data about the average time required to process a request for
certification. A few commenters reported that it takes an average of 79 to 80 days to issue a certification.
One commenter stated that it has received approximately 16 requests for certification per year, and
another commenter stated it has processed 458 certification requests in the last three years. One
commenter stated that their typical certification timeline (upon receiving a complete application) includes
a 1-2 week review period, a 30-day public notice, and a 2-4 week management review and response to
comment period. One commenter stated that Virginia's Department of Environmental Quality (DEQ) has
noted that while most 401 actions requiring public comment can be completed within 110 to 130 days,
certifications for more complex projects can take longer, especially where incomplete applications are
submitted. Another commenter stated that approximately 90% of their certification are issued within 60

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days, and for the majority of those issued beyond 60 days, the certifying authority was required to request
additional information from the project proponent. The commenter also provided that some of its
concerns regarding the reasonable period of time were partially ameliorated by proposed section 121.5(b)
and the definition of "receipt."

Agency's Response: EPA finds that several provisions of the final rule will help to minimize
delays in the certification process, including but not limited to pre-filing meeting
coordination and a greater availability of information afforded to the certifying authority at
the beginning of the certification review process under the final rule (as compared to the
2020 Rule). See Section 4.4 of the Final Rule Economic Analysis for further discussion.

The Agency appreciates the quantitative data that some commenters shared. The data was
incorporated as appropriate into the economic analysis of the final rule to provide insight
into the timing of certification decisions. See Final Rule Economic Analysis.

4.4 Extensions to the "Reasonable Period of Time"

4.4.1 A utomatic Extensions

All commenters expressed support for extending the default reasonable period of time due to unforeseen
circumstances such as government closures or force majeure events. A commenter wrote that states
appreciated that the proposed rule accommodated certifying authorities' requirements for public notice or
"force majeure events." A few commenters explicitly supported maintaining the automatic extension
provision if the rule retains a default reasonable period of time.

Several commenters suggested that automatic extensions should be limited only to unforeseen events and
extensions should not include public comment and other known procedures that were in place at the time
the reasonable period of time was established. One of these commenters also noted that automatic
extensions should not be allowed for staff shortages or other reasons unrelated to the proposed project.

On the other hand, other commenters expressed support for an expanded list of situations that warrant
automatic extensions and for maximum flexibility in terms of extensions to address such things as public
hearings, responding to comments, revisions to the certification based on community engagement,
appeals under state laws, project complexity, and inadequate information or unresponsive project
proponents. A few commenters noted that while examples may be helpful, the rule should not include a
defined list or limit the circumstances under which extensions could be granted. Conversely, a few
commenters suggested that situations and reasonable standards for automatic extensions should be
established to provide for more efficiency and predictability.

Some commenters noted that the rule needs to provide more clarity such as specifically defining public
notice requirements and providing more details on how extensions would work. One commenter asserted
that automatic extensions should only be the period of time necessary for the certifying agency to satisfy
its public notice requirements, and that extensions be granted only if EPA finds that unusual
circumstances require a longer time.

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Agency's Response: The Agency appreciates commenter suggestions on reasons for
automatic extensions to the reasonable period of time. This final rule allows certifying
authorities, in limited circumstances, to unilaterally extend the reasonable period of time.
The final rule recognizes that there are circumstances the reasonable period of time should
be extended without the certifying authority needing to negotiate an agreement, including
where a certification decision cannot be rendered within the reasonable period of time due
to force majeure events (including, but not limited to, government closure or natural
disasters) and where the state or Tribal public notice and comment process that exists at the
time the written notification for an extension is received takes longer than the negotiated or
default reasonable period of time. The Agency is finalizing that extensions of the reasonable
period of time must occur to accommodate certifying authority public notice "procedures,"
rather than public notice "requirements" as was proposed. This change is consistent with
the statutory language that certifying authorities "shall establish procedures for public
notice in the case of all applications for certification." 33 U.S.C. 1341(a)(1). The change to
"procedures" also clarifies that extensions to the reasonable period of time could be due to
subsequent public hearing procedures.

The Agency disagrees with the commenter suggesting that automatic extensions should only
be granted if the Agency finds unusual circumstances for reasons discussed above and in
Section IV.D of the final rule preamble.

The Agency declines to add other scenarios or remove the limited list of scenarios that
require automatic extensions. The Agency maintains that providing a limited list of
scenarios that warrant automatic extensions promotes efficiency and clarity, while
providing some flexibility for stakeholders when unforeseen circumstances arise. EPA
retained the accommodation for public notice procedures in the list of circumstances
warranting extensions of the reasonable period of time to capture unanticipated
occurrences such as extended public notice periods. This approach also supports section
401 's emphasis on public notice opportunities and is consistent with the spirit of cooperative
federalism in balancing the interests of certifying authorities with those of Federal agencies.
See also Section IV.D of the final rule preamble for further discussion. To be clear, the
Agency finds that such extensions only apply to public notice procedures in effect at the
time the written notification for an extension is received. Due to the final rule's
collaborative approach to setting the reasonable period of time, which allows for
consideration of certifying authority public notice procedures, the Agency expects that the
need for automatic extensions to accommodate public notice procedures will be rare. In all
other instances, certifying authorities and Federal agencies may determine collaboratively
whether and how the reasonable period of time should be extended, as long as it does not
exceed one year.

In response to comments requesting more clarity on how automatic extensions would work,
the Agency has revised section 121.6 to clearly delineate automatic extensions from agreed-
upon extensions. Additionally, the Agency has revised what is now section 121.6(d) to clarify

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that in the certifying authority's notification to the Federal agency, it must identify how
much additional time is required by either the public notice procedures requirements or the
force majeure event in addition to the justification for such extension. To be clear,
automatic extensions shall not cause the reasonable period of time to exceed one year from
the date that the request for certification was received.

4.4.2 A greed-upon Extensions

Most of the commenters expressed support for the certifying authority and Federal agency agreeing to
extensions, after consulting with the project proponent, and the flexibility it would allow. One commenter
supported retaining a process for agreed-upon extensions if the final rule included a default reasonable
period of time. Conversely, a couple commenters expressed that the decision to extend the reasonable
period of time should only be at the discretion of the Federal agency, while another commenter suggested
that the certifying authority should have the sole discretion to extend the reasonable period of time. One
of these commenters stated that not having the Federal agency as the final decisionmaker would render
the 60-day default meaningless and there would be no way to address disagreements over extensions.

Several commenters noted that extensions should only be allowed under specific justifiable and
reasonable limits and that the concerns of the project proponent in terms of cost and project schedule be
taken into consideration. One commenter suggested that the rule should identify specific situations where
extensions should be granted and provide clearly defined provisions for extending the reasonable period
of time. Another commenter indicated that the proposed rule was unclear whether the EPA or the Federal
agency could deny the request for an extension if they did not agree with justification for the extension.

Some commenters stated that certifying authorities and Federal agencies should engage project
proponents as much as possible when determining whether to extend the reasonable period of time. A few
commenters noted that the concerns of the project proponent should be taken into consideration in terms
of extensions to the reasonable period of time. One commenter suggested that the certifying authority
should provide written justification for the extension request to both the Federal agency and the project
proponent. Conversely, other commenters suggested that consultation with project proponents be
removed from the regulatory text, or the language be change to notification rather than consultation when
determining to extend the reasonable period of time. Other commenters suggested the regulatory text be
clear that the project proponent does not have the ability to veto a final decision made by the certifying
authority and the Federal agency.

A couple of commenters stated that it is unclear how the project proponent has a role in the determination
of any extensions. One of the commenters said that the term "consulted" should be changed to given
"notice." On the other hand, a different commenter said that the project proponent should be able to
provide input on the reasonable period of time because the decision would impact the timing and planning
of the projects.

A few commenters specifically noted that extensions should not be permitted in situations where the
certifying authority fails to act with the reasonable period of time. One commenter suggested that
extensions to the reasonable period of time should not be allowed for any reason. A commenter said that

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EPA should clarify that the one-year language in the statute is indeed a deadline and if a certifying
authority does not act within that deadline, the certification is waived. Another commenter said that the
one-year statutory deadline cannot be bypassed by requests for additional information and resetting the
clock, which the commenter said the proposed rule may allow.

One commenter asserted that the proposed rule did not include any mechanism to extend the reasonable
period of time and would result in denials in instances where the certifying authority is waiting for the
project proponent to provide additional information. The commenter argued that this would lead to an
unnecessary burden on certifying authorities without any environmental benefit, and impact financial
aspects of the proposed project.

Agency's Response: Consistent with the collaborative approach for setting the reasonable
period of time, EPA maintains that the Federal agency and certifying authority should be
able to jointly agree to extend the reasonable period of time in most cases, provided the
extension does not exceed one year from the receipt of the request for certification. Aside
from these requirements, the Agency declines to define or limit circumstances under which
a certifying authority and Federal agency may agree to extend the reasonable period of
time. Rather, the Agency finds that both the Federal agency and certifying authority can
provide insight on the length of time a review needs to be extended, based on their
knowledge of the Federal licensing or permitting process and their knowledge of water
quality and applicable state or Tribal laws, respectively.

EPA holds that both the Federal agency and certifying authority must both agree to the
extension, unless the reason for the extension falls under one of the two automatic extension
categories as discussed in Section IV.D of the final rule preamble. Therefore, if one party
does not agree, then the extension cannot occur. See also Section IV.F and G for further
discussion on waivers resulting from failure to act within the reasonable period of time.

The Agency is not finalizing proposed text that would have required project proponent
consultation. Under this final rule, the project proponent does not play a role in setting the
reasonable period of time, see section 121.6(b), so it is unnecessary to provide the project
proponent with a role in extending the reasonable period of time. Additionally, considering
the annual average number of certification requests3 and therefore possible extension
requests, EPA finds it unreasonable to require project proponent consultation on all
requests for extension. However, the final rule does not prevent the certifying authority and
Federal agency from seeking input from the project proponent on any potential extensions.

The Agency strongly disagrees with the commenter asserting that extensions should not be
allowed for any reason. First, the statute does not address extending the reasonable period
of time once it has started; it does not prohibit extending the reasonable period of time as
long as the certifying authority "acts" within one year from the date the request for

3 EPA estimates that the average annual number of certification requests is 1,947 requests per certifying
authority. See Supporting Statement for the ICR.

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certification is received. Second, federal agency regulations allow for extensions to occur.
For example, several Federal agencies, including EPA and the Corps, have established
regulations allowing extensions to their default reasonable periods of time. See 40 CFR
124.53(c)(3) (2022) (allowing for a reasonable period of time greater than 60 days for
certification requests on NPDES permits where the EPA Regional Administrator finds
"unusual circumstances"); 33 CFR 325.2(b)(l)(ii) (allowing for a reasonable period of time
greater than 60 days for certification requests on Corps permits when the "district engineer
determines a shorter or longer period is reasonable for the state to act."). Additionally, the
2020 Rule allowed certifying authorities to request an extension of the reasonable period of
time. 40 CFR 121.6(d) (2020). Third, most of the commenters who addressed extensions of
the reasonable period of time supported allowing certifying authorities and Federal
agencies to agree to extensions. See the Final Rule Economic Analysis for further discussion
on the benefits associated with extensions to the reasonable period of time.

The Agency also disagrees with the commenter asserting that the proposed rule did not
provide a mechanism for extending the reasonable period of time. The Agency is finalizing
its proposed approach to extending the reasonable period of time, including allowing
certifying authorities and Federal agencies to determine collaboratively whether and how
the reasonable period of time should be extended, as well as allowing for automatic
extensions in limited scenarios, as long as it does not exceed one year. 40 CFR 121.6(d)-(e).

4.5 Withdrawal and Resubmittal

4.5.1 Support 2020 Rule Reading of Hoopa Valley Tribe

Some commenters strongly opposed the proposed removal of 40 CFR 121.6(e) (2020), citing various
cases in support of their opposition, including Hoopa Valley Tribe v. FERC, 913 F.3d 1099, 1105 (D.C.
Cir. 2019); TurlockIrrigation Dist. v. FERC, 36 F.4th 1179, 1182 (D.C. Cir. 2022); N.Y.S. Dep'tofEnv'l
Conserv'n v. FERC, 991 F.3d 439 (2d Cir. 2021); NC. Dep'tofEnvtl. Quality (NCDEQ) v. FERC, 3
F.4th 65 (4th Cir. 2021); SWRCB v. FERC, 2022 WL 3094576, at *9-10. (9th Cir. August 4, 2022). A few
commenters described the facts of NCDEQ v. FERC as highly unusual and distinct from Hoopa Valley,
accordingly, the commenters concluded that the Fourth Circuit decision does not justify EPA's proposed
revisions to 40 CFR 121.6(e). One commenter stated that the fact pattern that arose in NCDEQ v. FERC
would not happen under the 2020 Rule.

A couple commenters asserted that the final rule should state that the withdrawal and resubmittal process
is unlawful. One commenter asserted that EPA has a duty to ensure that the rulemaking revisions do not
allow for manipulation of the statutorily prescribed timeline, arguing that some states have abused the
certification process. The commenter further asserted that the 2020 Rule's position on withdrawals and
resubmittals have helped ensure that the certification process cannot be misused to delay or prevent
issuance of the license or permits. Commenters also disagreed with EPA's position that case-by-case
determinations of whether and when withdrawal and resubmittal of a certification request is appropriate
and asserted that the existing case law from Hoopa Valley clearly demonstrates the need for EPA to
enforce regulations to compel compliance with the express section 401 deadlines.

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Commenters who opposed EPA's proposed approach to refrain from taking a position on the legality of
withdrawing and resubmitting a request for certification asserted that this process may be used as a
loophole to circumvent the one-year time limit described in section 401, which would increase
uncertainty, increase costs, and indefinitely delay Federal licensing or permitting processes, especially if
there is an increase in litigation. Many of the commenters who opposed EPA's proposed approach
expressed concern that an open-ended process without guardrails would allow states and Tribes to hold
the Federal licensing or permitting process hostage and/or coerce project proponents into withdrawing
certification requests for feasible projects. These commenters described complex and sometimes
conflicting case law as evidence for why EPA should take a position in regulation against situations in
which a certifying authority requests the project proponent withdraw the certification request in order to
extend the certifying authority's review period. These commenters asserted that clarity is important in
distinguishing between a circumstance where the project proponent might withdraw their request for
certification and cases where the certifying authority attempts to delay the commencement or conclusion
of the certifying authority's review period.

Most of the commenters opposed to EPA's proposed approach pointed out that Congress was clear in
their intent for including the statutory maximum one-year period of time in section 401 to "guard against
a situation where the water pollution control authority in the State in which the activity is to be located . . .
simply sits on its hands and does nothing." See 115 Cong. Rec. at 9,259 (starting debate on H.R. 4148,
Water Quality Improvement Act of 1969), 9,264-65 (amendment offered and discussed), and 9,269
(amendment accepted) (Apr. 16, 1969). Therefore, these commenters asserted that it is outside of EPA's
authority to allow certifying authorities to pressure project proponents to withdraw and resubmit requests
for certification to extend the review period past the one year specified in the CWA. These commenters
urged EPA to retain the language of the existing regulation at 40 CFR 121.6(e) since Congress already
created a "bright line" in section 401 of one year.

A few commenters suggested that EPA should take a stance against the withdrawal and resubmittal of a
certification request to extend the reasonable period of time beyond the one-year statutory maximum
because under the proposed rule, the certifying authority would have a role in setting the reasonable
period of time in which they can act on the request for certification. One commenter stated that if a
project proponent submits all the information required by the certifying authority at the start, then there
should be few reasons to ask a project proponent to withdraw and resubmit the certification request.

Agency's Response: EPA disagrees with the above comments and is aware that, historically
under the 1971 Rule, certifying authorities sometimes asked project proponents to
withdraw and resubmit their requests for certification to restart the clock and provide more
time to complete their certification review. Neither the text of section 401 nor Hoopa Valley
Tribe categorically precludes withdrawal and resubmission of a request for certification.
EPA understands the concern expressed by the D.C. Circuit in Hoopa Valley Tribe that
prolonged withdrawal and resubmission "schemes" might—under certain facts—
unreasonably delay and frustrate the Federal licensing and permitting process. Yet, the
potential factual situations that might give rise to, and potentially justify, withdrawal and
resubmission of a request for certification are so varied that the Agency is not confident

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that it can create regulatory "bright lines" that adequately and fairly address each
situation. By EPA not taking a regulatory position on this issue, it is up to project
proponents, certifying authorities, and/or possibly Federal agencies to determine on a case-
by-case basis whether and when withdrawal and resubmittal of a request for certification is
appropriate. Such determinations are ultimately subject to judicial review based on their
individual facts.

4.5.2	Avoiding a Denial Without Prejudice

A few commenters asserted that withdrawal and resubmission of certification requests may occur to avoid
denials of certification. One commenter stated that timelines for projects that involve withdrawals and
resubmissions could be addressed on a case-by-case basis by the certifying authority consistent with state
and Tribal regulations. A few commenters suggested that allowing a certifying authority to discuss
withdrawal and resubmittal with a project proponent is in the project proponent's interest because they
may be able to avoid unnecessary denials of certification. Conversely, one commenter requested that EPA
expressly prohibit the use of certification denials as a way to avoid a constructive waiver of certification,
but the commenter suggested that project proponents should retain the ability to withdraw and resubmit
their requests for certification if they deem it in their interest. Another commenter stated that the 2020
Rule limitations on informational requirements and limitations on withdrawal and resubmission
exacerbated the same problem that certifying authorities were not able to properly consider all
information on water quality, water quantity, and habitat impacts for projects where the license period
may span decades.

Agency's Response: The Agency recognizes that there may be legitimate reasons for
withdrawing and resubmitting certification requests, including but not limited to the
following potential reasons: a new project proponent, project analyses are delayed, and/or
the project becomes temporarily infeasible due to financing or market conditions. Because
EPA is not taking a regulatory position on this issue, the final rule does not preclude a
project proponent from withdrawing and resubmitting a request for certification and lets
the certifying authorities, Federal agencies (e.g., as the project proponent where it is the
Federal agency issuing the license or permit), and/or possibly project proponents take the
lead in deciding whether it is reasonable.

The Agency disagrees with the commenter asserting that the Agency should categorically
prohibit the use of certification denials to avoid constructive waiver. See Section IV.F of the
final rule preamble for further discussion on certification decisions, including denials of
certification.

4.5.3	Limiting the Use of Withdrawal and Resubmittal

Some commenters expressed the need for safeguards in regulatory text outlining criteria where
withdrawal and resubmittal of a certification request are appropriate, such as major change to the project
route; the project becomes temporarily infeasible due to financing or market conditions; delays in project
analyses; a change to project/parent company ownership; when an applicant is unable or unwilling to

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provide the certifying authority with requested information; a change in law or regulation; a new
scientific development; or a need to conduct additional consultation or public outreach on water quality
impacts. One commenter recommended a requirement for the certifying authority and project proponent
to consult with the Federal agency prior to the withdrawal of a request for certification where there is a
pending license or permit application. One commenter asserted that any withdrawal and resubmittal
scheme is a violation of Section 401(a)(1), absent a genuine change of circumstance under section
401(a)(3).

Some commenters expressed that EPA should make clear that withdrawal and resubmission of requests
for certification may occur except where there is evidence that the certifying authority and applicant are
attempting to collude to thwart Congress's intention to avoid undue delay in processing applications. A
few of these commenters stated that EPA has an opportunity to avoid increased litigation and costly
project delays by providing guidance to Federal agencies and applicants in the final rule. One commenter
recommended that EPA expressly clarify the difference between a denial and resubmission and a
withdrawal and resubmission of a request for certification.

A few commenters pointed to NCDEQ v FERC, where the state agency continued to correspond with the
petitioner and therefore clearly intended to not abuse the withdrawal process. 3 F.4th 655, 669 (4th Cir.,
2021). One commenter stated that EPA's reluctance to describe limits pertaining to withdrawal and
resubmittal of requests for certification contrasts with EPA's willingness to wade into other areas where
the statute is ambiguous, so the commenter suggested that EPA finalize a provision that makes clear that
withdrawal and resubmissions are acceptable in the absence of evidence that the certifying authority and
applicant are attempting to collude to thwart Congress's intention to avoid undue delay in processing
applications. The commenter recommended that EPA include discussion around reasons that would
justify a withdrawal and resubmittal, and noted that even under the 2020 Rule provision, questions
remained (e.g., if the prohibition is on having the certifying authority require that the applicant withdraw
and resubmit, would something that falls short of a requirement be deemed permissible? What would
happen if an applicant radically changed its project and realizes that the certifying authority no longer has
the time it needs to evaluate the implications of those changes? Could the applicant voluntarily withdraw
its application rather than face a denial? What would stop an applicant in that circumstance from
withdrawing its application and then claiming—once the reasonable period expired—that the state or
Tribe waived its authority under section 401, because it implicitly required resubmission by making it
clear that the alternative was a denial?).

Although one commenter asserted that EPA should not allow for withdrawal and resubmittal of requests
for certification, the commenter suggested that EPA could require the certifying authority to provide
justification for any extension beyond the one-year timeline and require that the certifying authority
include a list of all requests for additional information or clarification necessary to complete the certifying
authority's analysis. Another commenter asserted that litigation risks and costs could be reduced if EPA
finalized a process where all parties should have to agree in writing to withdrawal and resubmission of the
request for certification, with the rationale for why it is appropriate to circumvent the statutorily mandated
one-year period.

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One commenter recommended that EPA expressly provide for a process to restart the reasonable period
of time through resubmission of remedied requests for certification following a denial without prejudice
or EPA presumptively limit the quantity of withdrawal and resubmittals to three or fewer one-year
periods.

Agency's Response: As discussed in the final rule preamble, EPA understands and shares
the concern expressed by the D.C. Circuit in Hoopa Valley Tribe that prolonged withdrawal
and resubmission "schemes" might—under certain facts—unreasonably delay and frustrate
the Federal licensing and permitting process. However, the Agency does not find that mere
coordination between the certifying authority and project proponent rises to the level of a
scheme. The potential factual situations that might give rise to, and potentially justify,
withdrawal and resubmission of a request for certification are so varied that the Agency is
not confident that it can create regulatory "bright lines" that adequately and fairly address
each situation. For example, the Agency recognizes that there may be legitimate reasons for
withdrawing and resubmitting certification requests, including but not limited to the
following potential reasons: a new project proponent, project analyses are delayed, and/or
the project becomes temporarily infeasible due to financing or market conditions. By EPA
not taking a regulatory position on this issue, it is up to project proponents, certifying
authorities, and/or possibly Federal agencies to determine on a case-by-case basis whether
and when withdrawal and resubmittal of a request for certification is appropriate. Such
determinations are ultimately subject to judicial review based on their individual facts.

As discussed in Section IV.D of the final rule preamble, EPA recognizes that the practice of
withdrawal and resubmittal has been subject to litigation. For example, in the Hoopa Valley
Tribe case, which featured highly unusual facts, the court rejected the particular "withdraw
and resubmit" strategy the project proponents and states had used to avoid waiver of
certification for a FERC license. 913 F.3d at 1105. The court held that a decade-long
"scheme" to subvert the one-year review period characterized by a formal agreement
between the certifying authority and the project proponent, whereby the project proponent
never submitted a new request, was inconsistent with the statute's one-year deadline. Id.
Significantly, the court said it was not addressing the legitimacy of a project proponent
withdrawing its request and then submitting a new one, or how different a new request had
to be to restart the one-year clock. Id. at 1104. On the other hand, at least three circuit
courts have acknowledged the possibility that withdrawal and resubmittal of a request for
certification may be a viable mechanism for addressing complex certification situations. See
NCDEQ, 3 F.4th at 676 (withdrawal and resubmittal was appropriate where the certifying
authority and project proponent did not engage in a coordinated scheme to evade the
reasonable period of time); NYSDEC, 884 F. 3d at 456 (noting in dicta that the state could
"request that the applicant withdraw and resubmit the application"); Cal. State Water Res.
Control Bd. v. FERC, 43 F. 4th 920 (9th Cir. 2022) (vacating FERC orders where FERC had
found that the certifying authority had waived certification by participating in a
coordinated scheme to allow the project proponent to withdraw and submit its application
for certification before the reasonable period of time expired). With the dynamic case law
related to the topic of withdrawal and resubmittal and the complexities of certain

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certification situations, EPA's approach in this final rule lets certifying authorities, Federal
agencies (e.g., as the project proponent where it is the Federal agency issuing the license or
permit), and/or possibly project proponents take the lead in deciding whether and when it is
reasonable to allow withdrawal and resubmittal of requests for certification.

Because the Agency is declining to take a position on this practice, the Agency is also
declining to provide any regulatory text on any process associated with this practice (e.g.,
which stakeholders must consult with each other, criteria for evaluating withdrawal and
resubmittal, justifications for withdrawing and resubmitting).

In response to the commenter requesting that the Agency develop a process for
resubmitting a request for certification after a denial, the Agency observes that the
certification process as described in this final rule at part 121 applies to any request for
certification. Section 401(a)(1) provides that a Federal license or permit may not be granted
if certification is denied, but it does not speak to new requests for certification following a
denial of certification. Nothing in section 401, nor this final rule, prohibits a project
proponent from re-applying for certification if a certifying authority denies its initial
request.

As discussed in Section IV.C.3 of the final rule preamble, a CWA section 401 certification
cannot be issued in the absence of a project proponent requesting certification for a Federal
license or permit that may result in any discharge into waters of the United States. If the
request for certification or Federal license or permit application was withdrawn, then the
certifying authority is no longer responsible for acting on the request for certification
because the pre-requisite "request" is absent.

4.5.4 Recommend Including Regulatory Text Supporting Practice of Withdrawal and
Resubmittal Approach

A few commenters disagreed with EPA's proposed approach and requested that EPA finalize a regulation
outlining that the practice of withdrawal and resubmission of a request for certification is appropriate,
especially where unexpected and significant changes with the project arise; where the environmental
review is incomplete; the existing application information is insufficient to ensure compliance with water
quality standards; a project proponent expects to add information to a request; the project proposal will
undergo significant modifications; or a project is found to contain no jurisdictional waters. A few
commenters argued that there is a need for regulations authorizing a process for withdrawal and
resubmission of requests for certification with improved or more complete information - especially when
there is a significant or unexpected project change. Another commenter argued that EPA should alleviate
the "national fallout" resulting from the Hoopa Valley Tribe opinion, whose narrow holding has been
misapplied by Federal agencies.

One commenter also requested that EPA clarify that "take any other action for the purpose of modifying
or restarting the established reasonable period of time" does not prohibit certifying authorities from

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denying section 401 certification without prejudice and the project proponent may resubmit a request for
certification which would restart the reasonable period of time.

Other commenters requested that EPA affirm in the final rule that when applicants withdraw requests for
certification, the certifying authority need not complete the certification process because there is no
longer a request for certification to act upon; these commenters stated that in the event that a new request
for certification is submitted, the reasonable period of time should be deemed to start anew. A few of
these commenters highlighted the fact that withdrawal of a certification request is in the applicant's
control rather than the certifying authority's, so an applicant's decision to resubmit a request for
certification should not be the basis for waiver of a certifying authority's authority. A few commenters
recommended that EPA provide clarity to certifying authorities that upon the withdrawal of a certification
request by the project proponent, the certifying authority is no longer obligated to issue a certification
decision, so that the certifying authority does not have to issue a denial of certification or run the risk of
involuntary waiver if the project proponent chooses to re-request certification.

Agency's Response: EPA disagrees that it is inappropriate for the Agency to decide not to

outline when withdrawal and resubmittal is appropriate. See the Agency's Response to

Comments in section 4.5.3.

4.5.5 Support No Regulatory Text on Withdrawal and Resubmittal for Flexibility

A few commenters supported EPA's proposed approach because flexibility is important for project
proponents and certifying authorities. These commenters agree with EPA's observation that some
circumstances may exist where restarting the reasonable period of time is appropriate and
acknowledgement that this area of the law is dynamic.

A few commenters suggested that EPA develop national or regional guidance on the practice of
withdrawal and resubmission of a request for certification where circuits have not split against the
practice. One commenter argued that short of including a regulatory provision specifically authorizing
withdrawals and resubmission, EPA should provide illustrative factual situations where such an action is
appropriate because there are more than ninety U.S. District Courts which could make this area of section
401 less clear. Another commenter described the need for more guidance to reduce litigation on the
withdrawal and resubmittal practice. To support this request, the commenter asserted that uncertainty
around this issue led a certifying authority to abandon their withdrawal and resubmittal attempt and
ultimately led to a decision that was less protective of water quality.

One commenter provided three arguments in support of the approach EPA proposed. First, the commenter
noted that the D.C. Circuit made clear that its decision in Hoopa Valley Tribe was limited to the
"coordinated withdrawal-and-resubmittal scheme" before it, and that it was not "resolv[ing] the
legitimacy" of other arrangements. 913 F.3d at 1103-04. Second, the commenter noted that the D.C.
Circuit acknowledged Hoopa Valley Tribe's, limited scope and declined to extend it to a situation in
which the water quality agencies denied certification without prejudice. TurlockIrrigation Dist. v. FERC,
36 F.4th 1179, 1183 (D.C. Cir. 2022). The commenter also noted that the Ninth Circuit rejected FERC's
conclusion that the California State Water Resources Control Board had waived its section 401 authority

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over several hydroelectric dams where the applicants had withdrawn and resubmitted their section 401
requests. California State Water Resources Control Bd. v. FERC, 2022 WL 3094576 (9th Cir. Aug. 4,
2022). Third, the commenter asserted that as a matter of policy, the practice of withdrawing and
resubmitting a certification request allows states and project proponents to avoid denials of certification
based on lack of information or when state administrative processes (such as public notice) have not been
completed.

A few other commenters disagreed with EPA's interpretation of the Hoopa Valley Tribe case in the 2020
Rule and therefore support EPA's proposed restrained approach.

One commenter supported EPA's proposed approach, but the commenter asserted that EPA's analysis
perpetuates the misconception that withdrawal and resubmission has occurred at the certifying authority's
direction. The commenter disagreed that EPA's proposal would leave it up to the certifying authorities to
decide on a case-by-case basis whether withdrawal and resubmittal is appropriate because it is the Federal
agency's authority to make the waiver determination, so EPA needs to clarify for all parties that the
certifying authority is not obligated to act on a withdrawn request within the one-year period. The
commenter asserted that there is no practical reason for the certifying authority to force an applicant to
maintain a pending request over the applicant's objection. Citing multiple cases, the commenter stated
that the question was not whether it was "appropriate" for the applicant to use the procedure, but whether
the applicant's use of the procedure should result in potential waiver of the certifying authority's right to
issue a certification decision.

Agency's Response: See Section IV.D.2 of the final rule preamble and the Agency's
Response to Comments in Section 4.5.1-4.5.3.

4.6 Input Received on Prior Rulemakings

4.6.1 Input on the 2019 Proposed rule

This sub-topic summarizes comments that were made on a previous proposed rulemaking and were
resubmitted by commenters in the docket for the 2022 proposed rule.

A commenter expressed concern that the timeframe proposed in the 2019 proposed rule would prevent
states from complying with section 401's requirement for public notice. The commenter said states'
administrative procedures and substantive requirements for evaluation of requests for section 401
certification have already been calibrated to comply with the statute's one-year review period, provided
applicants deliver adequate information. The commenter stated that EPA should not artificially constrain
decision-making timeframes, because such action would interfere with public input, and make it
impossible for states to comply with state law.

Some commenters stated that the one-year limit was reasonable, and they commend EPA for confirming
the limit. One of these commenters said smaller projects may be reviewed within six months or less. A
different commenter said that in order to guarantee that the required timeline for review is met, EPA
should also consider setting enforcement requirements for the one-year turnaround in the final rule.

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A commenter said they do not support adopting a one-size-fits all approach for setting the reasonable
period of time. This commenter recommends that the Federal agency set the reasonable period of time
and that EPA encourage Federal agencies to establish default timelines for different types of projects for
which they are commonly the lead Federal agency. The commenter further recommended that EPA
remind certifying authorities that the statute allows the Federal agency to set a reasonable period of time
that is less than one year, and that certifying authorities should ensure that their public notice
requirements can be satisfied within the reasonable period of time as determined by the Federal agency.

One commenter suggested that EPA clarify that the factors a Federal agency considers in determining a
reasonable period of time should be within the scope of section 401 certification. The commenter also
recommended that EPA eliminate the factor that Federal agencies consider the "potential need for
additional study or evaluation of water quality effects from the discharge."

A commenter said that there is a conflict of interest when a Federal agency is both the project proponent
and the Federal agency issuing the permit or license, and suggested that the Federal agency should consult
with the certifying authority when setting the reasonable period of time or determining whether conditions
apply.

A couple commenters expressed support for the 2019 proposed rule's prohibition of the withdrawal and
resubmittal approach. One of these commenters supported the prohibition of certifying authorities
requesting project proponents to withdraw and resubmit, but they recommended that EPA clarify that the
project proponent can withdraw its request for consideration by the certifying authority at any time, e.g.,
if it no longer intends to develop the proposed project as described in its original request for certification.

One commenter recommended that EPA clarify that certifying authorities may deny a certification request
without prejudice, as long as they provide a statement explaining why the project will not comply with
water quality requirements and the specific water quality data or information that would be needed to
grant certification.

A commenter stated that Federal agencies should consider identifying interim milestone dates within the
reasonable period of time to share expectations of the certifying authority's progress. The commenter said
these milestones could include defining the time, such as 30 days, by which the certifying authority
should request from the applicant additional information that is within the scope of section 401. The
commenter added that EPA has included such a milestone in the proposed rule for when EPA is the
certifying authority.

Another commenter said EPA should provide clear direction that Congress was clear that the states' role
was temporally limited to a reasonable period of time, not to exceed one year, from the date of receipt of
the certification request.

One commenter stated that Federal agency can modify the reasonable period of time, provided it remains
reasonable and does not exceed one year from receipt of the request for certification.

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A commenter asked for clarification on what it means to be the "same request," such that the withdrawal
and submission of the same section 401 request does not restart the reasonable period of time for review.

One commenter claimed that EPA is dictating the timing of review certification applications, despite
section 401 only requiring that states act within a reasonable period of time up to one year. Another
commenter said that EPA should not impose more than section 401 requires nor should it prohibit the
withdrawal and resubmittal process.

A commenter said that EPA needs to ensure states can comply with their own administrative procedures
and not unnecessarily limit their timeframe for reviewing 401 applications. The commenter added that
EPA should provide applicants with the flexibility to extend administrative review through the
withdrawal and resubmission of applications. Lastly, the commenter said nothing in the section 401 text
or legislative history gives EPA or other Federal agencies authority to establish Federal oversight of
timing for state action, other than the one-year maximum.

Another commenter said any review/waiver timelines proposed by EPA must provide a reasonable
interpretation of what constitutes a flexible timeframe to review and act on applications. The commenter
stated that affording states the full one-year period under the CWA, or at a minimum providing flexibility
to easily extend the timeframe for review up to the one-year period, will ensure that states have a
meaningful opportunity to fully evaluate the potential impacts of Federal projects and ensure state water
quality is protected, as is consistent with the goal and intent of section 401.

One commenter expressed concern about the timeframe for review being constrained to one year and not
allowing the withdrawal and resubmittal approach for additional study, especially with the timeframe
starting at the date of request no matter if the application is complete. The commenter also expressed
concern about agencies having the ability to dramatically reduce the one-year statutory clock that state
agencies have to complete the certification process and about limits for how long the certifying authority
may request additional information; supportive of "reasonable period of time" extensions.

A commenter expressed support for the reasonable period of time generally being considered six months
with a one-year maximum. The commenter also said that the timeframe should be triggered when the
request is complete, and that the certifying authority is not authorized to request the project proponent to
withdraw a certification request or to take any other action for the purpose of modifying or restarting the
clock.

In expressing their assertion that states and Tribes are the only ones who can evaluate their needs for
reviewing applications, a commenter said that any delays are generally due to actions/inactions of project
proponent (e.g., incomplete or poor-quality applications, slow response), and they added that only in rare
instances do states withhold certification. The commenter further stated that substituting Federal
judgment over that of states goes against the state authority established in the CWA.

Agency's Response: See Section IV.D of the final rule preamble and the Agency's Response
to Comments in Section 4.1-4.5.

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See also Section IV.H of the final rule preamble for further discussion on the Agency's
removal of time constraints on requests for additional information when EPA acts as the
certifying authority.

4.6.2 Pre-proposal Input from 2021

This sub-topic summarizes input that was received prior to the 2022 proposed rule and was resubmitted
by commenters in the docket for the 2022 proposed rule.

A stakeholder said that states and Tribes should define what is a reasonable time for them to make their
CWA section 401 decisions for 3 reasons: (1) states and Tribes have the expertise to know how much
time it takes to conduct a proper review; (2) they have varying staff sizes and 401 program workloads, a
factor not considered by EPA's 2020 Rule; and (3) EPA's 2020 Rule will force certifying authorities to
violate their own regulations. Another stakeholder opposed the Federal agency setting the reasonable
period of time. The stakeholder argued that states are in the best position to determine the timeframe
needed. One stakeholder said that EPA should not restrict the time and information allotted to states and
Tribes to make certification decisions. The stakeholder expressed concern about undercutting states and
Tribes with the clock being controlled by project proponents and Federal agencies.

On the other hand, another stakeholder said the lead Federal agency has the authority to set the reasonable
period of time. One stakeholder said that allowing all 50 states and other certifying authorities to establish
different timeliness for review increases instability and inefficiency. This stakeholder supports the Federal
agency setting the reasonable period of time, asserting that they have set it for decades and it is consistent
with judicial and administrative precedent. Another stakeholder said there needs to be predictability in the
timeframes that certifying authorities have to review certification requests. The stakeholder asserted that
401 certification is a Federal program, and as such, it is inappropriate for stakeholders other than Federal
agencies to have a decision-making role in setting or extending the reasonable period of time.

A different stakeholder said to give Tribes and states a role in determining what the reasonable period of
time is, along with the Federal permitting agency. The stakeholder stated that their suggested approach
would better align with the text and cooperative principles of the CWA.

One stakeholder also called for EPA to eliminate the prohibition of the withdrawal and resubmittal
approach, because the prohibition is not supported by section 401 text, purpose, or legislative history and
has the effect of forcing state agencies to issue unnecessary section 401 denials. The stakeholder asserted
that the withdrawal and resubmittal approach has long been used without controversy by applicants and
state agencies where it is clear that additional time is required.

A stakeholder said EPA should clarify that states have up to one year to act on section 401 requests that
are complete pursuant to state administrative laws. The stakeholder added that EPA should encourage
other Federal agencies to conform their section 401 procedures to EPA's forthcoming rule and should
ensure that other Federal agencies recognize and accept state agencies' primary authority to determine the
reasonable period of time (of up to one year) necessary to act on section 401 requests.

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A stakeholder expressed concerns with 2020 Rule's waiver provisions. The stakeholder called for the
repeal of the 2020 Rule immediately and for EPA to start from scratch with a new rule designed to
achieve, and not flout, the objective and goals of the CWA.

One stakeholder said that the far stricter deadlines in the rule have been inflexibly applied by Federal
agencies regardless of the complexity of projects.

A stakeholder said to provide a full year for the review of water quality certification requests, unless
otherwise specified in Federal agency regulations or based on a Federal agency's categorical
determination. The stakeholder added that where case-by-case determinations are not provided by the
Federal agencies within 15 days, the default time period should also be one year.

One stakeholder said that EPA should immediately rescind the 2020 Rule while it undertakes the process
of updating the section 401 regulations. The commenter also said that the Corps' regulations concerning
water quality certifications should be revised to eliminate the standard review period of time from 60 days
and increase it to at least six months.

Agency's Response: See Section IV.D of the final rule preamble and the Agency's Response
to Comments in Section 4.1-4.5.

See also Section IV.M of the final rule preamble for further discussion on existing Federal
agency regulations implementing section 401.

5. Scope of Certification (Section 121.3)

5.1 Activity Scope of Certification

5.1.1 CWA arguments
5.1.1.1 Support for Proposed Approach

Many commenters who supported the "activity as a whole" scope argued that it is consistent with the
CWA and Supreme Court precedent, while the 2020 Rule's "discharge-only" interpretation of section 401
was inconsistent with the text, structure, and legislative history of section 401.

Some commenters asserted that the language, intent, and history behind the CWA support an activity as a
whole approach. One commenter argued that the CWA was intentionally written with broad and flexible
language to allow certifying authorities to use section 401 to manage the challenges and conditions
unique to their water resources. Another commenter argued that the activity as a whole interpretation
aligns with the original intention of section 401 to provide certifying authorities with the authority to
effectively protect their water resources from potential pollution. Another commenter asserted that the
activity as a whole scope of review is consistent with the CWA's mission and will ensure certifying
authorities can ensure the activity will comply with water quality standards. One commenter asserted that
section 401 embodies the central purpose of the CWA to ensure Federal projects will not jeopardize the

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joint federal-state efforts to achieve the goals of the CWA and asserted that "minor changes" to what
became section 401 were to advance the objectives in the 1972 Act to protect the chemical, physical, and
biological integrity of the nation's waters. The commenter also argued that section 401 is the "primary
mechanism [] through which states may exercise" their statutory role "as the prime bulwark in the effort to
abate water pollution" from federally approved projects, citing Delaware Riverkeeper Network v. FERC,
857 F.3d 388, 393-94 (D.C. Cir. 2017). Another commenter asserted that Congress has consistently
focused on ensuring the compliance of an "activity" from the enactment of Section 21(b) to the
incorporation of section 401 in the 1972 CWA, noting that from its inception, section 401 was described
as requiring any "activities that threaten to pollute the environment be subjected to the examination of the
environmental improvement agency of the State for an evaluation." Senate Debate on S. 3770 (Nov. 2,
1971), reproduced in Legislative History Vol. 2 at 1388.

Several commenters asserted that limiting the scope of certification to the discharge is inconsistent with
the CWA. One commenter argued that a "discharge-only" scope of certification is inconsistent with the
plain language of the CWA. First, the commenter asserted that it makes no sense to limit conditions to
discharges when there is no requirement for discharges to occur, but rather section 401 just requires
projects that have a potential to discharge to trigger section 401. Second, the commenter argued that
Congress used two different terms to describe when a section 401 certification is required and the scope
of conditions that can be imposed on the project once the need for certification is established. The
commenter noted that the term "discharge" as used in section 401(a)(1) means something different than
"applicant" in section 401(d), citing Transbrasil S.A. Linhas Aereas v. U.S. Dep 't ofTransp., 791 F.2d
202, 205 (D.C. Cir. 1986) ("[W]here different terms are used in a single piece of legislation, the court
must presume that Congress intended the terms to have different meanings." (quoting Wilson v. Turnage,
750 F.2d 1086, 1091 (D.C. Cir. 1984)). The commenter further asserted that Congress chose to allow
certifying authorities to add conditions to assure that any applicant, and not just any discharge, will
comply with water quality related laws, and argued that EPA has no authority to override that language
choice in a rulemaking. Another commenter asserted that a discharge-only interpretation of section 401(d)
is unreasonable because it is Congress' intent to "assure that Federal licensing or permitting agencies
cannot override State water quality requirements" (quoting Sierra Club v. U.S. Army Corps of Eng 'rs, 909
F.3d 635, 647-48 (4th Cir. 2018)). Another commenter argued that an interpretation of section 401 that
confines states and Tribes to regulating discharges is inconsistent with these fundamental principles of the
CWA. The commenter further asserted that section 401 serves "to assure that Federal licensing or
permitting agencies cannot override state water quality requirements," S. Rep. No. 92-414, at 69 (1971),
and specifically to ensure "that a federally licensed or permitted activity . . . [is] certified to comply with
State water quality standards" before its construction or operation. H.R. Rep. No. 95-830, at 96 (1977).
However, as asserted by the commenter, that objective can only be fulfilled if states and Tribes can
regulate the water quality effects of projects as a whole and any other approach (such as a discharge-only
approach) renders the text, structure, purpose, and legislative history of the CWA incoherent as written.
Another commenter noted that the "activity as a whole" interpretation is the only interpretation that is
consistent with the "purpose of the certification mechanism ... [which] is to assure that Federal licensing
or permitting agencies cannot override State water quality requirements." S. Rep. No. 92-414, 1972
U.S.C.C.A.N. 3668, 3735. The commenter further asserted that limiting the scope of certification to the
"discharge" would severely curtail the states and Tribes' ability to assure compliance with designated
uses and narrative water quality criteria, which would subvert the states and Tribes' authority to restore

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the chemical, biological, and physical integrity of a river affected by a federally licensed project. Another
commenter asserted that the legislative history of the 1972 amendments to the Federal Water Pollution
Control Act (FWPCA) contradict the 2020 Rule's "discharge-only" interpretation. The commenter cited
to legislative history for section 21(b) as evidence that Congress originally intended a broad scope, and
then cited to legislative history to the 1972 amendments as evidence that Congress understood it was
making only "minor" changes. The commenter added that in 1972 Congress added 401(d) which
expanded, not weakened, the authority of certifying authorities.

One commenter asserted that EPA is required to revise the 2020 Rule's scope of certification for two
reasons. First, the commenter argued that Congress did not delegate authority to EPA to interpret section
401(d) because it clearly indicates that certifying authorities consider the activity as a whole. Second, the
commenter asserted that even if Congress delegated authority to EPA to interpret section 401(d), any
interpretation narrowing the scope of review would be unreasonable because it would be contrary to
Congressional intent and decades of judicial and agency practice. The commenter argued that the
Agency's argument that section 401(d) is ambiguous is unpersuasive because section 401(d) plainly
provides the certifying authority with the authority to assure that the applicant will comply with
applicable water quality requirements by imposing limitations on the Federal license or permit. Instead,
the commenter argued that Congress' decision to include words in one subsection of a statute and exclude
them from another is additional evidence of Congress' clear intent {citingMedina Tovar v. Zuchowski,
982 F.3d 631, 635 (9th Cir. 2020)). The commenter also asserted that the Court in PUD No. 1 arrived at
its interpretation by relying on "the traditional tools of statutory construction", which acted as further
indication that Congress's intent in passing Section 401(d) was clear, and the fact that the Court stated the
1971 Rule offered a reasonable interpretation was not dispositive because it applied to the 1970 version of
the Act. Lastly, the commenter asserted that Congress confirmed its intent for section 401(d) to apply
broadly because it acquiesced to the PUD No. 1 holding and attempts to revise Section 401 had been
rejected (citing Gen. Dynamics LandSys., Inc. v. Cline, 540 U.S. 581, 593-94 (2004)).

Agency's Response: See Section IV.E.2.a of the final rule preamble.

5.1.1.2 Do Not Support Proposed Approach

Some commenters argued that the proposed scope of certification did not comport with the CWA's text,
structure, or legislative history. A few commenters asserted that the text of section 401 unambiguously
limits the scope of certification to discharges. Many of these commenters provided little to no supporting
analysis.

Agency's Response: The Agency disagrees with commenter assertions that the proposed or
final rule scope of certification does not comport with the CWA's text, structure, or
legislative history. See Section IV.E.2 of the final rule preamble and the Agency's Response
to Comments below for further discussion on how the final rule's scope of certification
comports with the CWA's text, structure, and legislative history.

The Agency also disagrees with commenters asserting that section 401 unambiguously limits
the scope of certification to discharge and finds that although the Supreme Court's

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assessment of the statute in PUD No. 1 is the best reading of the text with regard to the
proper scope of certification, the text is subject to more than one possible interpretation.
EPA's conclusion is supported not only by the two separate sets of commenters arguing in
support of contrary "plain meaning" interpretations of the proper scope but also by the
Supreme Court's interpretation of the statute in PUD No. 1. The Supreme Court held that
the text regarding the scope of certification "is most reasonably read" the way EPA
interprets the statute in this final rule. 511 U.S. at 712. In the 2020 Rule, EPA likewise
acknowledged that the statutory language addressing scope of review is subject to more
than one possible interpretation. See 85 FR 42232, 42251 ("The Agency also disagrees with
commenters who asserted that the scope of certification is expressed unambiguously in
section 401. As demonstrated by the variation in public comments received, section 401 is
susceptible to a multitude of interpretations. The EPA also disagrees with the suggestion
that the PUD No. 1 Court found section 401 to be unambiguous."). Congress' use of
"discharge" and "activity" in section 401(a)(1) and "applicant" instead of "discharge" in
section 401(d) introduced some uncertainty as to the proper scope of section 401 review and
conditions. In this final rule, EPA is following the Supreme Court's authoritative
interpretation of the statute while also exercising its authority granted by Congress to
construe, interpret, and implement the CWA.

5.1.1.2.1 Statutory-based Arguments

A few commenters asserted that the Agency's statutory analysis of the scope of certification started with a
specific policy endpoint in mind. One commenter asserted that EPA's statutory analysis began with the
result in mind, rather than finding ambiguity and requested that the Agency show a clear statement from
Congress that authorizes the proposed scope.

Several commenters argued that the Agency ignored changes to the statutory text between 1970 and 1972.
One commenter argued that EPA did not explain why it accepted the change from "water quality
standards" to "water quality requirements" but rejected the revisions to section 401(a)(1) and asserted that
it was arbitrary and capricious to only accept revisions to broaden the scope but not those to limit the
scope. A few commenters asserted that Congress's 1972 revisions to the certification requirement support
a "discharge-only" approach. These commenters argued that in its 1972 revisions, Congress expressly
limits the certification requirement to the "discharge," rather than the "activity." In support, one
commenter argued that this interpretation is consistent with the presumption that statutory amendments
are intended to have real and substantial effect, and quoted S.D. Warren for the proposition that "when
Congress fine-tunes its statutory definitions, it tends to do so with a purpose in mind." A couple
commenters asserted that Congress' revised certification language reflected the new emphasis in the
CWA on directly regulating point source discharges of pollutants, away from indirectly regulating
activities through ambient water quality standards. One commenter asserted that while the proposal states
that it does not find Congress's change from "activity" to "discharge" to be persuasive, it provides no
alternative explanation as to why Congress made this change. Another commenter asserted that the 1972
CWA amendments revised the certification provisions from a focus on whether the activity would violate
water quality standards to a focus on the impact of the proposed discharge and new language to allow
certifying authorities to condition certifications to assure compliance from the applicant. One commenter

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asserted that EPA's statutory analysis supporting the proposed scope of certification is flawed for several
reasons. First, the commenter argued that it was not necessary or appropriate to go beyond the text and
evaluate the legislative history because the text of the statute was changed from "activity" to "discharge"
citing NLRB v. SW Gen., Inc., 137 S. Ct. 929. 942 (2017); City of Chicago v. Envtl. Def. Fund, 511 U.S.
328, 337 (1994); Lawson v. FMR LLC, 134 S. Ct. 1158, 1176-77 (2014). Second, the commenter argued
that Congress changed the statute, and the Agency must adhere to it, citing Ctr. for Biological Diversity v.
Zinke, 313 F. Supp. 3d 976, 989 (Alaska 2018); Food & Drug Admin, v. Brown & Williamson Tobacco
Corp., 529 U.S. 120, 125 (2000). Third, the commenter argued that EPA did not explain its change in
position from the 2020 Rule in sufficient detail, namely whether the Agency no longer agrees that
Congressional amendments have real effects. The commenter asserted that the Agency's analysis
misrelied on Whitman v. Am. Trucking Ass 'ns, 531 U.S. 457, 468 (2001), and did not explain why
Congress did not use the word "activity" instead of "applicant." Furthermore, the commenter argued that
EPA's analysis to "daisy chain" from discharge to applicant to activity as a whole would be unnecessary
if the Agency applied the plain language analysis of the text and concluded that the Agency's statutory
interpretation was arbitrary and capricious and inconsistent with basic canons of statutory construction.

Several commenters argued that expanding the scope of certification to the activity as a whole without a
connection to discharge would contravene the statutory language. One commenter asserted that section
401(a) provides the trigger for certification review and the scope of review and argued that there was no
basis for EPA to read the term "discharge" out of statute. The commenter further argued that section
401(d) does not address the scope of review, but rather addresses how the discharge complies, and the
reference to the "applicant" is necessary since the focus of section 401(d) is on conditions incorporated
into the applicant's permit. The commenter also asserted that it is unreasonable to read "applicant" in
section 401(d) as revising the specificity in section 401(a)(1) regarding discharges. Rather, the commenter
noted that section 401(d) does not authorize a certifying authority to set conditions on the activity as a
whole or the activity. One commenter argued that the proposed scope of certification expanded section
401 beyond the CWA and EPA's authority. The commenter argued that EPA's interpretation of scope
would render section 401(a) meaningless and questioned why Congress limited the triggering action to a
point source discharge into a water of the United States if Congress wanted certifying authorities to
review all conditions regardless of the source. The commenter further asserted that section 401 should be
read in context with sections 402 and 404 because they are all core regulatory provisions of the CWA and
have been consistently limited to review of point source discharges into navigable waters. The commenter
argued that if Congress wanted section 401 to have a different scope from sections 402 and 404 then it
would have unambiguously articulated that.

Some commenters disagreed with how section 401(d) factored into EPA's proposed interpretation of
scope. A few commenters argued that section 401(a)(1) unambiguously limits the scope of certification to
discharges, and that the reference in subsection 401(d) to the "applicant's" compliance does not create
any ambiguity regarding the scope of certification. One commenter asserted that section 401(d) was a
limited and narrow provision, and that EPA's proposed interpretation of scope places too much weight on
section 401(d) and not enough on section 401(a)(1), which the commenter asserted created the framework
and foundation for the entire certification process. Another commenter argued that the Agency failed to
explain why it believes Congress intended the term "applicant" in section 401(d) to mean "activity as a
whole," stating that they did not believe references to activity in the legislative history were enough and

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asserting that it is inappropriate to rely on legislative history to negate changes made to the plain language
of the statute (citing NLRB v. SW Gen., Inc., 137 S. Ct. 929, 942-43 (2017)). One commenter argued that
the reference in section 401(d) indicates only who must comply with certification conditions, and says
nothing about which activities of the applicant are subject to certification. According to the commenter, in
context, the reference to the applicant's compliance can only be a reference to the applicant's compliance
with the requirements applicable to the applicant's discharges that are the subject of the certification.
Another commenter argued that section 401(d)'s requirement that the certification set forth requirements
for the applicant, and not the discharge, makes sense because a certification is not some abstraction; it is a
document that a certifying authority gives to a person or entity, and it describes what that person or entity
must do to ensure that its discharges comply with water quality requirements. That commenter referenced
the principle of statutory construction that the meaning of a word cannot be determined in isolation, but
must be drawn from the context in which it is used, and argued that this principle supported the
commenter's interpretation of 401(d). Another commenter asserted that the use of "applicant" in section
401(d) makes sense because the certification describes what the person must do to ensure its discharges
comply with water quality requirements and argued that the 1972 amendments transformed the Act to
focus on direct regulation of discharge. The commenter further argued that any certification and
conditions have an overarching purpose to assure point source discharges from federally licensed or
permitted projects will not violate water quality requirements, yet EPA ignored this interpretation and
instead pointed to varied terms and concluded they created ambiguity. The commenter asserted that
EPA's interpretation was invalid because the Agency used statutory ambiguity to misconstrue section
401(a)(1) for predetermined policy objectives, although the commenter claims section 401(a)(1)
unambiguously limits the scope to discharges.

A few commenters that argued in support for "discharge-only" and stated that the CWA sections for
which section 401(d) requires compliance—CWA sections 301, 302, 306, and 307—regulate only
discharges. One such commenter noted that section 401(a)(1) also requires certification that the discharge
will comply with CWA section 303, which is not listed in section 401(d). The commenter stated that
section 303 requires the establishment of water quality standards, but it does not itself require compliance
with the standards. The commenter continued that section 301, however, requires point source discharges
to comply with water quality standards established under Section 303, citing to 33 U.S.C. 1311(b)(1)(C).
Thus, according to the commenter, certification conditions to ensure that discharges comply with section
301 must necessarily ensure that the discharges comply with water quality standards established under
section 303.

A few commenters disagreed with the Agency's interpretation of other subsections in support of its
proposed "activity as a whole" interpretation. One commenter argued that sections 401(a)(3)-(5) support a
"discharge-only" approach because they concern compliance with CWA sections 301, 302, 303, 306 and
307, all of which, the commenter argued, regulate only discharges. The commenter disagreed with the
proposal preamble that these paragraphs support a broader scope of certification. Another commenter
asserted that, in addition to 401(a)(1), the other elements of section 401 are consistently limited to
discharges and do not extend more broadly to the "activity as a whole." The commenter noted that section
401(a)(2) allows a neighboring state or Tribe to object to the issuance of the Federal license or permit if
the "discharge will affect the quality of its waters." The commenter asserted that the "neighboring
jurisdiction" provisions of the proposal are consistent with paragraph 401(a)(2) in limiting consideration

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of the effects on neighboring jurisdictions to the "discharge" from the project or activity. The commenter
found it notable that the preamble to the proposal does not discuss the implications of 401(a)(2) for the
scope of certification, even though the preamble does include a relatively detailed discussion of the other
subsection 401(a) paragraphs in this context. Another commenter asserted that EPA's statutory analysis
attempted to create textual support using sections 401(a)(3)-(5) where there is no support, arguing that the
terms "construction" and "operation" were not inconsistent with section 401(a)(1). The commenter
further argued that EPA failed to recognize that sections 401(a)(3)-(5) referenced certifications issued
pursuant to section 401(a)(1). Additionally, the commenter argued that EPA did not explain why it
adopted "discharge" in some sections, such as section 401(a)(2), but would replace the term with "activity
as a whole" elsewhere, which the commenter asserted made the legal interpretation arbitrary and
capricious.

One commenter argued that a broader scope beyond "discharge-only" is not necessary to protect water
quality because nothing in section 401 or the CWA limits the authority of states or Tribes to protect water
quality under their own laws, nor do states or Tribes require any authorization under the CWA to protect
water quality. The commenter cited to the preservation of state authority in section 510. The commenter
offered an example. According to the commenter, if EPA issues an NPDES permit to authorize a
discharge pursuant to CWA section 402, a state or Tribe may, independently of section 401 and the CWA,
regulate or prohibit the discharge, regardless of EPA's issuance of a NPDES permit authorizing it, citing
to 40 CFR 122.5(c). The commenter similarly asserted that a state or Tribe may independently regulate or
prohibit a discharge under its own laws that is authorized under a Corps CWA section 404 permit, citing
33 CFR 320.4(j). According to the commenter, the only circumstances in which the scope of certification
may influence a state's ability to regulate an activity that affects water quality are those few instances in
which some other Federal law preempts or restricts the state's regulatory authority over the activity,
including hydropower projects licensed by FERC. The commenter asserted that even in those instances,
the Federal licensing or permitting agency is almost always charged with ensuring protection of water
quality after considering the views of the state and other public and private interests. The commenter
offers FERC hydropower licenses as an example in support of this assertion.

One commenter asserted that the Agency's interpretation of ambiguity in section 401 was unreasonable
and arbitrary in light of the statutory text and structure of the CWA because the Agency defined a term
that does not exist in section 401 (referring to "activity as a whole"), the proposal ignores that Congress
replaced "activity" with "discharge" in section 401(a), and it would allow a section 404 permit to remain
in effect over a project for as long as whatever is built on, around, or near the permitted fill exists or
operates.

Agency's Response: See the Agency's Response to Comments in Section 5.1.1.2.

The Agency disagrees with commenters asserting that the Agency's statutory analysis of the
scope of certification began with a specific policy endpoint in mind or that the Agency
ignored changes to the statutory text between 1970 and 1972. Rather, having now carefully
reconsidered the 2020 Rule's "discharge-only" interpretation of scope of review, EPA has
concluded that the best reading of the statutory text is that the scope of certification is the
activity subject to the Federal license or permit, not merely its potential point source

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discharges. This reading is further supported by the legislative history of section 401,
Supreme Court precedent, and the goals of section 401, which include recognition of the
central role that states and authorized Tribes play in protecting their own waters. It also
realigns scope with accepted practice for the preceding 50 years. Consistent with this
interpretation, EPA is finalizing revisions to section 121.3 that reaffirm the activity scope of
review that Congress intended when it first enacted the water quality certification provision
in 1970 and reaffirmed when it amended the CWA in 1972 and 1977. Additionally, in
response to comments, EPA is finalizing revisions to section 121.3 that clarify important
limiting principles and provide greater regulatory certainty. See Section IV.E of the final
rule preamble for further discussion on the Agency's analysis of the statutory text.

EPA strongly disagrees with commenter assertions that revisions to section 401 in the 1972
amendments to the CWA reflected a changed emphasis to directly regulating point source
discharges of pollutants. As discussed in section IV.A of the final rule preamble, the
statutory definition of "discharge" is broad and is not limited to a discharge of pollutants.
Additionally, this interpretation is consistent with the text of the statute as interpreted by
the U.S. Supreme Court. See Section IV.A of the final rule preamble for further discussion
on the term "discharge" in section 401. Congress did significantly revise the statutory water
quality protection framework in 1972, focusing more on effluent limitations and numeric
limits than water quality standards to try to drive down pollution levels. While EPA agrees
that the 1972 amendments reflected a new overall emphasis in the CWA on regulating point
source discharges (through section 402 NPDES permits and section 404 dredge and fill
permits), this does not change EPA's conclusion regarding how best to interpret the scope
of section 401. Section 401 predates these discharge-related permitting provisions and, even
after the 1972 amendments, remains significantly different in character. It remains a direct
Congressional grant of authority for states and authorized Tribes to protect their water
resources from impacts caused by federally licensed or permitted projects. While Congress
largely retained the water quality certification scheme it enacted in 1970, it did make
several revisions, including some in the subsections relevant to interpreting the scope of
certification. As discussed in section IV.E.2.a.iii of the final rule preamble, the legislative
history shows that when Congress was enacting new discharge-related permitting
provisions in 1972, it had no intention of fundamentally constraining the certification power
that Congress granted just two years before.

EPA disagrees with and finds unpersuasive commenter attempts to conflate section 401
with sections 402 and 404. First, while section 401 is in the same subchapter as section 402
and section 404, the placement of a section into the same subchapter as other sections offers
little interpretative value in this instance. The subchapter is titled "permits and licenses."
While section 402 and 404 programs are markedly different from section 401 certification,
they all concern "permits and licenses," so it makes sense that they share this subchapter
(along with other sections regarding permitting). However, they are otherwise markedly
different; sections 402 and 404 create Federal permitting programs specific to point source
discharges of pollutants, whereas section 401 is a direct Congressional grant of authority to
states to protect their waters from all federally licensed or permitted activities, including

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those that do not need section 402 or 404 permits. Indeed, section 401 predates both the
section 402 and section 404 programs, existing before Congress later adopted these
discharge-focused provisions. Further, section 401 explicitly authorizes states to add
conditions to ensure compliance with requirements of state or Tribal laws beyond those
typically considered for section 402 or section 404 permits (e.g., beyond EPA-approved state
water quality standards effective under the CWA). Even the trigger for sections 402 and
404 differs from section 401. Sections 402 and 404 require an actual point source discharge,
see e.g., Waterkeeper Alliance, v. EPA, 399 F.3d 486, 504-06 (2d Cir. 2005), whereas section
401 requires the potential for a discharge. See Section IV.A.2.b of the final rule preamble.
Moreover, section 402 and 404 permits are required for discharges that include pollutants,
whereas section 401 certification is required for "any discharge" even for discharges
without pollutants. See Section IV.A.2.C of the final rule preamble. In the 1972 amendments,
Congress was unambiguously clear that section 402 and 404 permits are limited to
regulating point source discharges of pollutants. Congress could have been equally clear
about section 401, but made revisions that, when read holistically, strongly indicate that
Congress intended to maintain a "scope" that encompassed the entire activity subject to the
relevant Federal license or permit.

The Agency disagrees with commenters arguing that the CWA sections for which section
401(d) requires compliance regulate only point source discharges. In addition to CWA
sections 301, 302, 306, and 307, section 401 also requires compliance with CWA section 303.
33 U.S.C. 1341(a)(1), (d). Section 303 is not limited to regulating point-source discharges.
Section 303 concerns establishment of water quality standards, identification of waters that
do not meet those standards, and establishment of daily maximum pollutant loads for such
waters, all of which go well beyond regulation of point source discharges. See Section
IV.E.2.a, c in the final rule preamble for further discussion on why the listed provisions in
section 401(a)(1) and section 401(d) comport with an activity-based scope of certification.

In response to commenters appearing to argue that sections 401(a)(3)-(5) apply only to
"discharges" related to the "construction or operation" of a "facility or activity," EPA
disagrees that this represents the best interpretation of sections 401(a)(3)-(5) when
considering the text of section 401 as a whole. Congress could have easily limited sections
401(a)(3)-(5) to point source discharges by using language such as "discharges related to the
construction or operation of a facility." One commenter argued that sections 401(a)(3)-(5)
support a "discharge-only" approach because they concern compliance with CWA sections
301, 302, 303, 306 and 307, all of which, the commenter argues, regulate only discharges.
EPA disagrees; as described above, section 303 goes beyond regulating point source
discharges. EPA does not find the list of CWA sections identified in sections 401(a)(3)-(5)
persuasive to adopt a "discharge-only" scope of certification considering the weighty
support for an activity-based scope in the text and legislative history. See also Section
IV.E.2 for further discussion on additional textual support for the activity scope of
certification.

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For further discussion on the scope of section 401(a)(2), see Section IV.K of the final rule
preamble and Section 11.1.4 of the Agency's Response to Comments.

The Agency disagrees with the commenter asserting that a broader scope beyond
"discharge-only" is not necessary to protect water quality because of other federal or state
laws or Federal agency roles in ensuring protection of water quality. First, the Agency is not
adopting its interpretation of scope because it finds it is necessary to protect water quality
but because the Agency has concluded that it represents the best reading of the statutory
text. Second, as the commenter concedes, there are instances where state regulatory
authority is preempted or restricted over the activity by Federal law (e.g., in the case of
FERC licensed projects). Further, the commenter fails to acknowledge the impetus behind
the creation of a state water quality certification program ~ Federal agencies were failing to
comply with state laws and regulations regarding water quality standards. As discussed in
Section III.A of the final rule preamble, Federal agencies were issuing licenses and permits
"without any assurance that [water quality] standards [would] be met or even considered."
S. Rep. No. 91-351, at 3 (August 7,1969). While Federal agencies may consider water
quality impacts independently, Congress made clear that the purpose of section 401 was to
empower states to protect their waters from the effects of federally licensed or permitted
projects and "assure that Federal licensing or permitting agencies cannot override State
water quality requirements." S. Rep. No. 92-414, at 69 (1971). Accordingly, the Agency
disagrees that other state or Federal laws provide water quality protection benefits
tantamount to those provided by section 401. See also Section IV.E of the final rule
preamble and Section 5 of the Agency's Response to Comments for additional public
comments and discussion on the water quality impacts of a "discharge-only" scope of
certification.

In response to the commenter who asserted that the Agency defined a term ("activity as a
whole") that does not exist in section 401, in this final rule, the Agency is removing the
phrase "as a whole" from the regulatory text throughout Part 121. See Section IV.E for
further discussion on the removal of the phrase "as a whole" and why this modification does
not represent a change in substance from proposal.

The Agency disagrees with the commenter who asserted that the activity scope of
certification allows a section 404 permit to remain in effect over a project for as long as
whatever is built on, around, or near the permitted fill exists or operates. EPA emphasizes
that—for purposes of section 401—certification conditions cannot "live on" past the
expiration of the Federal permit to which they attach. Section 401(d) requires certification
conditions to be incorporated into the Federal license or permit. Accordingly, once the
Federal license or permit expires, any certification conditions incorporated into the Federal
license or permit also expire. This principle holds true regardless of the scope of section 401.
See Section IV.E.2.b of the final rule preamble for further discussion.

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5.1.1.2.2 Congressional Intent Arguments

A few commenters argued that the proposed scope of certification was inconsistent with Congressional
intent. One commenter argued that Congress intended section 401 to apply to water quality impacts from
the permitted activity and not unrelated impacts far removed from the project itself. Another commenter
argued that the activity as a whole scope must be bound to the discharge, or it would contravene
Congress's intent that Federal permits covering discharges into navigable waters comply with applicable
water quality requirements. One commenter who discussed hydropower projects also provided a detailed
discussion of the history of section 401 in support of the commenter's arguments about limiting the scope
of certification. The commenter asserted that based on the commenter's interpretation of this history,
Congress intended for section 401 certifications to focus on point source discharges only.

Agency's Response: EPA disagrees with commenter assertions that the proposed scope of
certification was inconsistent with Congressional intent. See Section IV.E.2.a of the final
rule preamble for further discussion on the activity scope of certification and Congressional
intent. For further discussion on the water quality limitations inherent in section 401, see
Section IV.E.2.b, c of the final rule preamble.

EPA disagrees with commenter assertions that the overall goal and purpose of section 401 is
only to ensure that any point source discharge will comply with CWA water quality
provisions. See Section IV.E.2.C of the final rule preamble for further discussion on why
EPA finds that the text, purpose, and legislative history of the statute support the final
definition of "water quality requirements," which appropriately allows certifying
authorities to certify compliance with the enumerated provisions of the CWA and state and
Tribal water quality-related provisions (for both point and nonpoint sources).

5.1.2 Case Law/PUD No. 1 Arguments

5.1.2.1 Support for Proposed Approach

Many commenters who supported the "activity as a whole" scope of the proposed rule asserted that it was
affirmed by the Supreme Court in PUD No. 1. Commenters agreed with EPA's proposal that the existence
of "discharges" is the trigger for section 401 review, but that the scope of review is broader. Many of
these commenters noted that EPA's proposed interpretation is consistent with the Supreme Court's
interpretation in PUD No. 1. A few commenters noted specifically that the Court endorsed the "activity as
a whole" scope as the "most reasonable" interpretation of the statute. Some commenters expressed
agreement with the interpretation taken in the proposal of section 401(d) regarding scope of certification,
noting that it was consistent with the interpretation taken by the Court in PUD No. 1. Several commenters
argued that the Court analyzed the statutory text in section 401 and determined that a certifying authority
was not limited to imposing conditions specifically tied to a discharge according to the plain language of
sections 401(a) and 401(d). One commenter noted that the Court identified the clear and key differences
in language between sections 401(a) and (d) to make clear that Congress intended states to have
certification authority over the activity as a whole, and not just the discharge. Another commenter

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asserted that the Court in PUD No. 1 expressly rejected the notion that under section 401(d) a certifying
authority is only empowered to regulate the discharge that triggered the certification process.

Similarly, some commenters asserted that the 2020 Rule is inconsistent with PUD No. 1. A few such
commenters argued that the Court's holding was based on the unambiguous language of the statute, and
that the Court's opinion did not turn on deference. One commenter disagreed with EPA's position from
the 2020 Rule that the term "discharge" in section 401(a) was ambiguous, and instead asserted that the
majority in PUD No. 1 did not identify any ambiguity in section 401 because the plain language of
section 401 clearly addressed impacts of an activity as a whole.

One commenter asserted that the 2020 Rule is inconsistent with the Supreme Court decision in S.D.
Warren, which the commenter characterized as recognizing the integral role section 401 certifications
play in upholding state and Tribal authority to address a broad range of pollution.

Agency's Response: The 2020 Rule rejected the scope of certification affirmed by the
Supreme Court in PUD No. 1, precedent in effect for a quarter of a century. In PUD No. 1,
the Court held, based on a textual analysis, that section 401 "is most reasonably read" as
authorizing the certifying authority to place conditions on what the Court described as the
"project in general" or the "activity as a whole" once the predicate existence of a discharge
is satisfied. 511 U.S. at 711-12. EPA agrees with the Court's interpretation regarding the
proper scope of certification. Specifically, EPA agrees with the Court's analysis of section
401(a)(1) and section 401(d), and, as discussed in Section IV.E.2.a of the final rule preamble,
has identified further support for its conclusion in additional statutory text of section 401
beyond what the Court analyzed in PUD No. 1, the legislative history of section 401, the
water quality protection goals of section 401, and the principles of cooperative federalism
that underlie the CWA. See Section IV.E.2.a of the final rule preamble for further
discussion regarding PUD No. 1.

See also the Agency's Response to Comments in Section 5.1.1.2.

5.1.2.2 Do Not Support Proposed Approach

A few commenters asserted that EPA's interpretation of PUD No. 1 did not support the proposed
approach to scope of certification. One commenter argued that PUD No. 1 focused on the permissibility
of one type of certification condition in a fact-specific circumstance and that outside of that context, the
use of Section 401(d) to regulate the activity as a whole is statutorily prohibited, asserting that the Court's
fact-specific interpretation of section 401(d) to allow certifying authorities to regulate the activity as a
whole must yield to statutorily mandated fields of preemption.

Another commenter argued that the Court did not substantively support EPA's approach that the "activity
as a whole" governs a certifying authority's decision to grant or deny a certification. Citing PUD No. 1,
the commenter asserted that the Court distinguished Section 401(a)(1) from section 401(d) and explained
that Section 401(a)(1) addresses the scope of the certification while Section 401(d) addresses the scope of
conditions. The commenter further argued that EPA conflated the provisions without any basis in text and

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in a manner inconsistent with principles of statutory construction. The same commenter also asserted that
the Court in PUD No. 1 did not support applying Section 401(d) conditions beyond what is required to
comply with water quality standards. Another commenter argued that the 2020 Rule's discharge-only
approach is the only plausible interpretation of section 401(a) and asserted that the proposal erroneously
applied the activity as a whole concept from section 401(d) to section 401(a) and that the Court never
considered nor endorsed such an interpretation in PUD No. 1. The commenter further asserted that the
scope of certification was not at issue in the case, and the Court discussed section 401(a) only to illustrate
its differences with section 401(d) and was very clear that the scope of review under section 401(a) and
the conditions that may be imposed on the "activity as a whole" under Section 401(d) are very different
things. The commenter concluded that the PUD No. 1 Court favored the 2020 Rule's interpretation and
argued that it provided no support for section 401(d) to apply to 401(a).

One commenter stated that while the proposal relies on the Supreme Court decision in PUD No. 1 to
support a return to "activity as a whole," that case did not hold that the "activity as a whole" approach
was required by the text of the statute, nor was the Supreme Court in that case considering an EPA
interpretation of that text. The commenter stated that despite the holding in PUD No. 1, under the Brand
X doctrine EPA retained the ability to depart from the Supreme Court's reading of the text.

A few commenters asserted that the PUD No. 1 Court was misinformed because of the 1971 Rule. One
commenter argued that the PUD No. 1 decision and a significant portion of jurisprudence on section 401
is based on judicial deference to EPA regulations that predate the 1972 CWA amendments and should be
distinguished on this basis. Another commenter asserted that this significantly undermines the validity
and applicability of the PUD No. 1 decision and should not be relied upon for the rulemaking. One
commenter asserted that the 2020 Rule identified concerns with the PUD No. 1 analysis and decision,
including that the Court did not consider the practical effects of its decision and relied on EPA's
regulations because it believed it reflected the Agency's interpretation of section 401. The commenter
argued that the Court was not informed that the 1971 Rule was substantively inconsistent with section
401, and that the Court and EPA's proposal did not grapple with whether the entire range of activities
potentially included are appropriate for review within the certification program. The commenter
concluded that the Agency adopted the PUD No. 1 analysis wholesale without addressing shortcomings in
the decision because it aligns with the Agency's policy preference. Another commenter asserted that the
Court in PUD No. 1 relied on, and deferred to, EPA's 1971 certification rule and guidance derived from
that rule. The commenter stated that both the Court majority and the dissent were apparently unaware that
Congress had revised the statute in 1972 and that the EPA rule was based on the pre-1972 version of the
statute. The commenter expressed disagreement with the proposal characterizing this apparent
unawareness as of "minor significance" and asserted instead that it meant that the Court's decision cannot
be relied on to support the proposal's broad scope of certification.

One commenter asserted that that the PUD No. 1 Court misconstrued subsection (d) and argued that it
does not authorize certifying authorities to conduct a free-ranging survey of state law to impose
conditions on certification. Rather, the commenter said it should be construed analogous to the operating
permit program Title V of the Clean Air Act to authorize certifying authorities at most to establish
monitoring requirements to ensure that other, applicable provisions are fulfilled.

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Agency's Response: See Section IV.E.2.a of the final rule preamble for further discussion
regarding PUD No. 1, including responses to comments regarding the 1971 Rule.

EPA disagrees that PUD No. 1 can be read so narrowly as to apply only to the facts of the
case. Nowhere did the Court suggest its holding was so limited. The Court first interpreted
the text of section 401 before applying its interpretation to the specific facts before it.

EPA disagrees that the Court in PUD No. 1 explicitly limited its holding to the scope of
section 401(d) conditions and not the scope of section 401 certification overall. At issue
before the Court was a certification condition, therefore it is hardly surprising the Court
focused its analysis around the proper scope of certification conditions. However, in
identifying the issue before it, the Court did state that it was considering the scope of State
authority under section 401 more broadly. Id. at 710 ("The principal dispute in this case
concerns whether the minimum stream flow requirement that the State imposed ... is a
permissible condition of a § 401 certification under the Clean Water Act. To resolve this
dispute we must first determine the scope of the State's authority under § 401."). Even if the
Court did not directly consider the proper scope for certification decisions (as opposed to
certification conditions), the Court certainly never suggested that the scope for a
certification decision must be more limited than scope for certification conditions. The
Court held that section 401(a)(1) "identifies the category of activities subject to
certification—namely, those with discharges," and section 401(d) "is most reasonably read
as authorizing additional conditions and limitations on the activity as a whole once the
threshold condition, the existence of a discharge, is satisfied." Id. at 711-12. In other words,
the Court explained that there must be a potential discharge before certification is required
(which is clear from the statute), but the Court never suggested that certification decisions
are somehow limited to considering the water quality effects of only that potential
discharge. As explained at section IV.E.2.e of the final rule preamble, sections 401(a)(1) and
401(d) are inextricably linked and by far the most reasonable reading of the two is that the
same scope applies to a both the decision whether to grant certification and whether that
certification requires conditions. If the scope for certification decisions was actually
"discharge-only" while the scope for certification conditions was the full activity subject to
the Federal license or permit, then the scope for a decision whether to grant certification
would be considerably narrower than the scope of any conditions that could accompany a
grant of certification. That would lead to odd or even absurd results. For example, if a
certifying authority grants certification regarding a point source discharge (because the
point source discharge will comply with water quality requirements), the certifying
authority must then shift gears to a different inquiry and consider the water quality impacts
of the full activity subject to the Federal license or permit and add conditions necessary to
assure that the activity will comply with water quality requirements. But if the certifying
authority determines that no conditions can assure that the activity will comply with water
quality requirements, it still cannot deny certification.

The Agency disagrees with the commenter suggesting that the Court's holding in PUD No. 1
and/or the Agency's proposed approach to scope of certification would somehow authorize

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certifying authorities to conduct a free-ranging survey of state law to impose conditions on
certification. See Section IV.E for further discussion on the types of conditions that are
within the scope of certification under this final rule.

5.1.3 Support Activity Based Scope for Other Reasons

5.1.3.1	Longstanding Practice

Many commenters supported the Agency's "activity as a whole" scope of certification. Several of these
commenters indicated that the "activity as a whole" scope was consistent with EPA's longstanding
interpretation and certifying authority practice prior to the 2020 Rule, citing to EPA's 1989 and 2010
Guidance. One commenter argued that the broad language in Section 401 has consistently been
interpreted and applied as allowing a certifying authority to review a project's impacts on water quality.
One commenter agreed that the activity as a whole scope better aligns with cooperative federalism
principles. Another commenter noted that the activity as a whole scope aligned with its state certification
procedures. A commenter said that many states support the readoption of the activity as a whole approach
for scope of certification review.

Agency's Response: See Section IV.E of the final rule preamble.

5.1.3.2	Water Quality Reasons

Some commenters argued that an "activity as a whole" scope was necessary for certifying authorities to
holistically protect their waters, and several commenters asserted that analyzing the activity as a whole
makes section 401 more effective in protecting water quality and achieving water quality goals. One
commenter argued that the discharge only approach to section 401 would allow activities to occur that can
result in violations of water quality requirements, such as impacts from reduced stream flows, thermal
loading from removal of streamside vegetation, increases or decreases in sediment load, and destabilized
stream banks, and ultimately undermine Congress's intention to provide states and Tribes with a tool to
protect their water resources. Another commenter asserted that without the activity as a whole
interpretation, certifications would underestimate the implications of projects on watershed scales and
hamper the ability of certifying authorities to manage designated uses. Another commenter argued that
activities, such as land use or disturbance directly adjacent to streams and wetlands, have a direct
relationship to the biological, physical, and chemical components and overall health of the water resource.
One commenter asserted that the activity as a whole approach would better enable states and territories to
obtain needed information to understand an activity's water quality impact, which would make review
more efficient and predictable.

One commenter asserted the activity as a whole approach is important to consider impacts
comprehensively for piecemealed projects. Another commenter stated that projects in its state do not
always seek certification for each individual Federal permit that a project requires, so the activity as a
whole approach would allow the state to evaluate whether the project in general is protective of state
waters.

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Several commenters discussed the importance of the "activity as a whole" scope for hydroelectric dam
projects. One commenter asserted that the activity as a whole scope is necessary to fulfill the CWA's
purpose of allowing states to address the "broad range of pollution" affecting their waters and provided
examples of the water quality impacts from hydroelectric dams that are not tied to a specific discharge
(e.g., increased water temperature from decreased water flows, vegetation loss and reduced shading from
dam reservoirs, fish kills from turbines, increased toxin mobility from elevated turbidity). Another
commenter also supported the activity as a whole scope of certification, arguing that the discharge from
the powerhouse or tailrace of FERC-licensed hydropower projects are not the only impacts from those
projects, but rather they are federally-licensed activities that fundamentally alter the chemical, physical,
and biological integrity of a river. One commenter argued that the proposed scope is necessary to achieve
Congress' intent in the CWA to protect and restore the quality of the nation's waters with respect to
FERC-licensed hydropower projects. The commenter noted that section 401 provides one of the few
exceptions to Federal preemption of state law on FERC-licensed projects and asserted that limiting the
scope to just the discharge would leave unregulated the impacts from stormwater and wastewater
discharge and eutrophication and oxygen depletion from the activity. Another commenter asserted that the
activity as a whole scope would allow certifying authorities to protect their waters and the communities
that rely on and use those waters and discussed the water quality impacts from the Conowingo Dam that
were non-discharge related.

Regarding dams more generally, one commenter asserted that reviewing only the discharge would leave
water quality impacts unmitigated and described impacts from a dam that would be unaddressed under a
discharge-only scope, including change in the timing and flow of water, blockage of nutrients, and altered
chemical makeup of water due to reservoirs. Another commenter discussed the impacts of dam alterations
of natural flow regimes, including the chemical, physical, and biological properties of riverine
ecosystems, as identified in an EPA report (Final EPA-USGS Technical Report: Protecting Aquatic Life
from Effects of Hydrologic Alteration. EPA Report 822-R-16-007/USGS Scientific Investigations Report
2016-5164 (2016)).

Agency's Response: The Agency agrees that greater water quality protection could result
from an "activity" scope of certification, in addition to the fact that an "activity" scope best
reflects Congressional intent and appropriately restores consistency with the "activity as a
whole" scope that the Supreme Court affirmed in PUD No. 1 over a quarter of a century
before the 2020 Rule. As commenters observed, the distinction between certifying the
activity or only its associated discharges is more than semantic and can in some cases have
significant consequences for water quality protection. By allowing states and authorized
Tribes to protect their water quality from the full activity made possible by a Federal
license or permit, the "activity" scope of certification effectuates Congress's goal of
maximizing protection of the nation's waters by providing an independent grant of
authority to states and authorized Tribes to ensure that federally licensed or permitted
activities do not frustrate attainment of their water quality protection goals. See Section
IV.E.2 for further discussion.

In response to the commenter who stated that projects in the commenter's state do not
always seek certification for each individual Federal permit that a project requires, the

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Agency notes that a project proponent may only rely on the same certification obtained for
the construction of a facility for any Federal operating license or permit for the facility if 1)
the Federal agency issuing the operating license or permit notifies the certifying authority,
and 2) the certifying authority does not within 60 days thereafter notify the Federal agency
that "there is no longer reasonable assurance that there will be compliance with applicable
provisions of sections [301, 302, 303, 306 and 307 of the CWA]." 33 U.S.C. 1341(a)(3). The
Agency finds that section 401(a)(3) provides compelling textual support for the reading that
section 401 is not constrained to those activities directly authorized by the Federal license or
permit in question or the point source discharge. See Section IV.E.2.a, b for further
discussion on why section 401(a)(3)-(5) adds more support to an "activity" based scope of
certification.

5.1.4 Additional 2020 Rule Specific Input

Some commenters described challenges and issues with the "discharge-only" scope of certification from
the 2020 Rule, arguing that it is too narrow, limits certifying authorities' ability to protect water quality,
and does not allow states to fully assess a proposed project's potential impacts on water quality. Several
commenters asserted that the 2020 Rule's interpretation of scope diminished their authority to include
certification conditions that protected water quality or consider critical issues, such as riparian loss or
long-term project operation impacts to water quality. One commenter asserted that the 2020 Rule
approach to scope would prevent the state from including conditions on monitoring, modeling, and
mitigation addressing potential water quality impacts.

Several commenters argued that the 2020 Rule's approach to scope of certification was illegal. A few of
these commenters asserted that the 2020 Rule unlawfully rejected Supreme Court precedent and EPA's
longstanding practice. One commenter said the proposed revisions to the scope of certification are
necessary to correct legal deficiencies from the 2020 Rule. One commenter argued that it would be
patently unreasonable to return to the 2020 Rule's discharge only approach for several reasons, including
because EPA admitted in the preamble that the activity as a whole scope was the longstanding approach
(citing Chamber of Com. of United States of Am. v. United States Dep 't of Lab., 885 F.3d 360, 380 (5th
Cir. 2018)), that it was not reasonable to assume Congress intended a fundamental change in scope based
on limited changes to statutory text, and that some water quality impacts would fall outside the scope of
the 2020 Rule.

Conversely, other commenters did not support the Agency's proposed scope of certification and
recommended retaining the "discharge-only" scope from the 2020 Rule. A few commenters argued that
the 2020 Rule provided a reasonable basis for the discharge-only approach to the scope of certification.
One commenter argued that EPA provided a detailed discussion of the statutory, regulatory, and legal
history of section 401 and established a clear framework to justify EPA's revisions. Another commenter
asserted that the 2020 Rule provided a reasoned legal basis for its scope of certification by analyzing the
different interpretations and rejecting those that did not closely align with the statutory text. The
commenter argued that the proposed rule disregarded the specific actions taken by Congress in favor of
the Agency's policy preference and asserted that the "activity as a whole" is inconsistent with the
statutory text and does not reflect an authentic legal interpretation. Another commenter argued that the

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2020 Rule's approach to the scope of certification focused states and Tribes on water quality and
promoted consistency across certifying authorities, and further asserted that the proposed scope would
create uncertainty, delay or disrupt clean energy projects, and allow significant expansion of certification
authority beyond what was intended by the CWA. Another commenter asserted that the 2020 Rule
explained how to read sections 401(a) and (d) together, but the proposal arbitrarily rejected this analysis
and uses the term "applicant" to unlawfully and unreasonably expand the scope of certification beyond
the CWA. One commenter stated that the 2020 Rule's scope of certification was appropriately limited to
the review of point source discharges into waters of the United States and the proposed rule's expansion
of the scope of certification is not consistent with the unambiguous text of section 401. Another
commenter asserted that the 2020 Rule scope is legally appropriate and makes the permitting program
more predictable for Federal agencies, Tribes, states, and project sponsors to navigate receiving the timely
permitting decision, which is important for private investors, predictability, and cost effectiveness. The
commenter further asserted that expanding the scope would conflict with the Administration's policy
goals on climate change and equity by slowing down much needed deployment of infrastructure projects.

Agency's Response: EPA is concerned that some, if not many, of the water quality-related
impacts identified by commenters might fall outside the scope of review under the 2020
Rule's "discharge-only" approach to scope of review. While the potential additional water
quality protections associated with the "activity"-based scope (as opposed to a "discharge-
only" scope) will vary depending on the nature, size, location, and type of project that
requires a Federal license or permit, this final rule provides the opportunity for additional
water quality protections compared to the 2020 Rule's approach. See Section IV.E of the
final rule preamble for further discussion on water quality harms of the 2020 Rule.

In response to commenters asserting that the 2020 Rule provided a more reasonable basis
for the scope of certification, EPA find that the 2020 Rule does not represent the best
statutory interpretation of the scope of certification. Instead, the best reading of the
statutory text is that the scope of certification is the activity subject to the Federal license or
permit, not merely its potential point source discharges. This reading is further supported
by the legislative history of section 401, authoritative Supreme Court precedent, and the
goals of section 401, which include recognition of the central role that states and authorized
Tribes play in protecting their own waters. It also realigns scope with accepted practice for
the preceding 50 years. See section IV.E of the final rule preamble for further discussion on
the potential adverse water quality-related impacts of the 2020 Rule's interpretation of the
scope of certification and why such an outcome is inconsistent with both the Act and
Congressional intent. Accordingly, the Agency strongly disagrees with commenters
asserting that the "activity" scope of certification is inconsistent with the statutory text or
does not reflect an authentic legal interpretation. The finalized approach returns to the
scope that is consistent with not only the statutory language and Congressional intent but
also longstanding Agency guidance and decades of Supreme Court case law. See Section
IV.E.2 of the final rule preamble for further discussion on the "activity" scope of
certification and the Agency's Response to Commenters in Section 5.1.

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As discussed throughout the preamble to the final rule, the Agency is finalizing revisions to
the 2020 Rule that best reflect the statutory text. These revisions also support a more
efficient, effective, and predictable certifying authority-driven certification process
consistent with the water quality protection and other policy goals of CWA section 401 and
Executive Order 13990. The 2020 Rule does not represent the best statutory interpretation
of fundamental concepts, such as the scope of certification, nor does it align with the
broader water quality protection goals of the Act or Congressional intent behind
development and passage of section 401. Therefore, the comparisons made by some
commenters regarding possible delays between the proposed approach and the 2020 Rule's
scope of certification (or any other aspect of the 2020 Rule) are somewhat misleading.
Accordingly, the Agency disagrees with commenter assertions that the "activity" scope of
certification would create uncertainty, delays, or disruptions to project deployment. First,
most certifying authorities are familiar with the "activity" approach and the final rule
clarifies that the scope of certification is limited to water quality-related impacts. Second,
although water quality impact analyses could take longer when considering the "activity" as
opposed to the "discharge only," in part because certifying authorities may request
additional information from project proponents to consider the "activity" in their section
401 reviews, such data requests are unlikely to place any incremental burden on project
proponents since these activity-related data requests may address data that project
proponents must compile in any event for the Federal license or permit application.

5.1.5 Activity as a Whole Definition

5.1.5.1 Did Not Support Proposed Activity as a Whole Definition

Many commenters who did not support the proposed scope of certification, also did not support the
proposed definition for the "activity as a whole." Several of these commenters disagreed with the
proposed definition because the commenters asserted that it was ambiguous and would lead to various
implementation challenges, such as regulatory uncertainty, increase litigation risk, increased project costs,
project delays, and inconsistent interpretations of scope across jurisdictions. One commenter argued that
even if the "activity as a whole" approach was lawful, the Agency had not adequately explained how the
term would function in practice, stating that the Agency did not describe the extent of project activity and
as a result, the definition would introduce regulatory uncertainty, litigation risk, and threaten
infrastructure projects. The commenter argued that the term is too vague to be consistently implemented
and violates the APA as an arbitrary and capacious provision. The commenter recommended that the
Agency either not use the term "project activity" or set limits on the extent of project activity to be
considered in the activity as a whole, suggesting that it should not include aspects of a project that have
received authorization for construction or operation. Similarly, another commenter argued that the
proposed scope of certification was so broad that it was effectively unknowable, which would create
financing uncertainties because it would prevent project proponents from planning in advance to develop
information needed for the certification process. Another commenter asserted that the definition of
"activity as a whole" undermines the specificity of the point source discharge requirement of certification.
One commenter stated that neither the Supreme Court in PUD No. 1 nor EPA have ever defined the scope
of this "activity as a whole" concept, and EPA did not purport to do so in the proposal.

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A few commenters requested that the Agency revise the proposed definition for "activity as a whole" to
provide more clarity on the boundaries of such a term, such as what impacts can be considered by the
certifying authority and how indirect the impacts may be to water quality. One commenter provided
recommended regulatory text revisions and suggested that proposed section 121.1(a) should read
"Activity as a whole means an aspect of the project activity that has reasonable potential to adversely
affect water quality" while proposed section 121.3 should read "When a certifying authority reviews a
request for certification, it shall evaluate whether there is reasonable assurance that the activity as a whole
will comply with all applicable water quality standards." Similarly, another commenter recommended
limiting the scope to the proposed project's impacts to water quality standards. One commenter
recommended revising proposed section 121.1(a) to read "means any aspect of the project activity with
the potential to affect water quality from the discharge." Another commenter requested that the Agency
provide opportunities for further public comment on the definition.

A few commenters that supported the proposed scope of certification asserted that the proposed definition
of "activity as a whole" was confusing. One commenter asserted that the definition was circular and
recommended that the Agency delete the word "activity" from the definition. The commenter also
suggested that the Agency should define the term "project" to clearly reference the entirety of whatever is
being licensed or permitted by the Federal agency. Another commenter stated that it should be the entire
project associated with the potential discharge into a water of the United States.

A few commenters asserted that the definition could be used by certifying authorities to impose
conditions on activities that may only be speculatively or obscurely linked to the actual discharge or used
as a vehicle to insert Federal jurisdiction over activities on waters that are not waters of the United States.
One of these commenters further argued that the definition does not clearly demarcate where authorities
under section 401 end and authorities under other CWA program begins (e.g., stormwater permitting
under CWA section 402), and would allow certifying authorities to condition any aspect of a dredged or
fill project permitted by the USACE or hydropower project licensed by FERC regardless of if it is directly
related to the discharge. Another commenter argued that the proposed definition would allow certifying
authorities to consider any aspect of the project for the duration of the activity that are not related to the
requirement of the Federal permit nor related to adverse effects. The commenter asserted that this would
lead to certifying authorities claiming they have limited ability to exclude a statistically insignificant
aspect of a project if it can have any affect at all on water quality. Another commenter argued that the
definition could allow a decision to be based on any activity of the "applicant," even those involving
wholly separate projects owned or operated by the applicant.

One commenter asserted that the proposed scope would allow circumvention of the one year statutory
maximum, e.g., where certification is for a section 404 permit on a hydropower dam, the certification
could impose additional requirements on the project after the one-year period for issuing the certification
occurs and after the FERC license was issued.

Agency's Response: The Agency appreciates commenter concerns regarding
implementation of the proposed definition of "activity as a whole". In response to these
comments and to aid in implementation of the final rule, the Agency has revised the

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regulatory text regarding the scope of certification. Although an activity-based scope of
certification had been the Agency's longstanding interpretation prior to the 2020 Rule and
should be familiar to stakeholders, the Agency is providing further clarification around the
"activity" subject to certification. See Section IV.E.2.b of the final rule preamble for further
discussion around removal of the definition for "activity as a whole" and subsequent
modifications at section 121.3 to articulate the activity subject to a certifying authority's
review.

EPA agrees with the commenter asserting that the Court in PUD No. 1 did not define the
"activity as a whole" term. When PUD No. 1 endorsed a scope of "activity as a whole"
almost thirty years ago, the Court did not offer a specific definition or explanation of that
term. Nevertheless, certifying authorities and Federal agencies have gained significant
experience over nearly 50 years implementing an "activity" approach, and EPA expects
that certifying authorities and Federal agencies remain capable of appropriately delineating
the "activity" based on the facts of each situation. EPA is not aware of and did not receive
any comments identifying any cases in which delineation of "activity" has been litigated,
provided that the scope of review was limited to water quality. Moreover, this final rule
addresses commenter concerns regarding regulatory certainty by clarifying important
limiting principles that inform delineation of the "activity" under review by the certifying
authority including that certifying authorities are limited to considering adverse impacts to
water quality from the activity subject to the Federal license or permit. See Section IV.E.2.b
of the final rule preamble.

In response to commenters suggesting that certification should be limited to assuring
compliance with water quality standards, the Agency disagrees. Rather, consistent with the
statutory text, this final rule requires certifying authorities to consider whether the activity
will comply with "water quality requirements," which includes but is not limited to water
quality standards. See Section III for further discussion on the textual changes from Section
21(b) to Section 401, and Section IV.E for further discussion on the term "water quality
requirements."

In response to commenters asserting that the scope of certification adopted in this final rule
will lead to certifying authorities placing conditions on Federal licenses or permits that are
speculatively linked to the actual discharge, the Agency first disagrees that scope is limited
to the point source discharge for reasons discussed in Section IV.E of the final rule
preamble. Nevertheless, even under an "activity" scope of certification, the Agency finds it
unnecessary to establish in this rulemaking how indirect or certain the impacts of the
activity may be to water quality. See Section IV.E.2.b of the final rule preamble for further
discussion on why the Agency reached this conclusion and responses to commenters. In
response to commenters asserting that an activity-based scope of certification will lead to
certifying authorities placing conditions on Federal licenses or permits for non-waters of the
United States, see Section IV.E.2.d for further discussion on the scope of waters.

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EPA disagrees that the final rule fails to demarcate where authorities under section 401 end
and authorities under other CWA programs begin. The final rule addresses section 401, not
other CWA programs. While CWA section 402 and 404 permits are subject to section 401
certification when issued by EPA or the Corps, this rule only addresses how section 401
applies to these permits.

The Agency strongly disagrees with commenters asserting that a scope encompassing the
full activity subject to the Federal license or permit instead of only its associated point
source discharges would allow certifying authorities to consider aspects of the project not
related to adverse effects on water quality. Under this rule, when a certifying authority
reviews a federally licensed or permitted activity, it must determine whether the activity
"will comply" with "water quality requirements." The phrase "will comply" used in
sections 401(a)(1) and 401(d) means that the certifying authority is limited to examining
whether the activity will meet existing water quality requirements; only if the activity will
not comply with such requirements, then section 401 provides certifying authorities with the
ability to either deny the activity where compliance cannot be ensured with conditions or
condition the activity in such way to assure compliance. Section 401(d) requires a certifying
authority to determine whether "the applicant" will—without additional conditions —
comply with the specified CWA provisions and "any other appropriate" requirement of
state law. Only if the certifying authority determines pursuant to section 401(d) that adding
"any effluent limitations and other limitations, and monitoring requirements" to the
Federal license or permit will assure that water quality requirements will be met, may the
certifying authority grant the certification contemplated by section 401(a)(1). Congress
intended for section 401 to act as a powerful tool to address adverse water quality impacts
from federally licensed or permitted activities and understood the implications of such a
tool. See 116 Cong. Rec. 8805, 8984 (1970) ("No polluter will be able to hide behind a
Federal license or permit as an excuse for a violation of water quality standard."); see also
S. Rep. 92-414, at 69 (1971) ("The purpose of the certification mechanism provided in this
law is to assure that Federal licensing or permitting agencies cannot override State water
quality requirements."). As noted in Section IV.E of the final rule preamble, certifying
authorities may use section 401 certifications to address adverse water quality impacts
either caused or contributed to by a Federally licensed or permitted activity.

The Agency finds that the statutory text and the legislative history clearly indicate
Congress's intention for a certifying authority to holistically consider impacts of the activity
subject to the Federal license or permit, including the activity's construction and operation.
Therefore, it would be appropriate for a certifying authority to consider the water quality-
related impacts associated with the operation of an activity even if the Federal license or
permit that triggered the need for certification is limited to the construction phase of the
activity. See 33 U.S.C. 1341(a)(3) and related discussion in the final rule preamble at Section
IV.E.2.b. The Agency disagrees that its interpretation extends to any activity of the
applicant. Rather, the final text at section 121.3 makes it clear that the analysis is limited to
the applicant's activity subject to the Federal license or permit at issue (and to considering
that activity's adverse impacts on water quality). The Agency revised its proposed

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regulatory text regarding the scope of certification to no longer refer to the "project
activity" in response to commenter confusion about the term. The final rule refers simply to
the "activity" subject to the Federal license or permit, instead of the "activity as a whole,"
the "project in general" or, as proposed, the "project activity." The Agency understands
these terms to be interchangeable.

In response to the commenter asserting that the "activity" scope of certification would allow
circumvention of the one year statutory maximum, the Agency disagrees. First, this final
rule does not allow certifying authorities to unilaterally add new certification conditions
after issuance of the certification decision and/or the Federal license or permit. See Section
IV.I for further discussion on modifications to grants of certification. However, to be clear,
the Agency does not consider so-called "adaptive management" conditions to be unilateral
modifications. See Section IV.F for further discussion on adaptive management conditions.
Second, for purposes of section 401, certification conditions cannot "live on" past the
expiration of the Federal permit to which they attach. Section 401(d) requires certification
conditions to be incorporated into the Federal license or permit. Accordingly, once the
Federal license or permit expires, any certification conditions incorporated into the Federal
license or permit also expire. This principle holds true regardless of the scope of section 401.
However, it does not mean that when a certifying authority considers whether to grant or
deny certification, the certifying authority is limited to considering only those aspects of the
activity that will occur before the expiration of the Federal license or permit. For example,
if the certifying authority determines that no conditions could assure that the activity,
including post-expiration aspects of the activity, will comply with water quality
requirements, denial of certification would be appropriate.

5.1.5.2 Support Proposed Activity as a Whole Definition

Several commenters supported the proposed definition for activity as a whole. One of these commenters
stated that they interpreted the term to include, but not be limited to, the construction or operation of the
project as well as impacts in addition to those which triggered the request for Section 401 certification.
Another commenter supported the definition as one that includes all activities that might affect water
quality both directly and indirectly, noting that such a definition would be consistent with the concept of
"proposed action" used in ESA consultations. One commenter stated that the proposed definition strikes a
good balance, while another commenter asserted that the clarification was necessary to allow state and
Tribes to meet their obligations under the CWA (citing Catskill Mountains Chapter of Trout Unltd., Inc.
v. EPA, 846 F.3d 492, 530 (2d Cir. 2017)). A commenter also argued that Congress intended for section
401 to give states and Tribes authority to guarantee that entire "facilities under a Federal license or permit
... will comply with [state and Tribal] water quality standards," not just that portions of facilities will
comply, citing S.D. Warren Co., 547 U.S. at 386 (quoting Sen. Muskie, 116 Cong. Rec. 8984 (1970)).

Agency's Response: The Agency is not finalizing the proposed definition for "activity as a
whole," and is clarifying the concept in section 121.3 instead. The final rule language
emphasizes that the activity subject to review can include, but is not limited to, the activity's
construction and operation. As discussed in section IV.E of the final rule preamble, the

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Agency also agrees with commenters asserting that Congress intended for section 401 to
allow certifying authorities to consider whether the entirety of an activity subject to the
Federal license or permit will comply with water quality requirements, not just the point
source discharges associated with the activity, and not just the portions of that activity
subject to the Federal license or permit at issue. See 33 U.S.C. 1341(a)(3) and discussion in
section IV.E of the final rule preamble.

See also the Agency's Response to Comments in Section 5.1.5.1.

5.1.6 Alternatives to Activity as a Whole

5.1.6.1 Support Alternative Definition of Activity as a Whole or Related

Some of the commenters who did not support the definition of "activity as a whole" supported defining
the term to mean "only those activities at the project site that are specifically authorized by the Federal
license or permit in question," a possible alternative definition that EPA invited comment on at proposal.
Another commenter argued that the "activity as a whole" should be limited to the activities authorized by
the Federal license or permit for which certification is required because it is consistent with the structure
of Section 401. The commenter argued that section 401 cannot authorize any activity by itself, but rather
it is a certification of compliance with specified legal requirements that is necessary to issue a Federal
license or permit, and if the license or permit is not issued, the certification has no legal effect. Given this,
the commenter argued that the scope of certification can be no broader than the activities authorized by
the Federal license or permit. The same commenter also argued that conditions based on activities other
than those authorized by the Federal license or permit could not be effectively implemented. One
commenter suggested that aspects of a particular infrastructure project that are outside of the Federal
permitting regime do not fall within the jurisdiction of Section 401 and should not be within the scope of
certification for states to evaluate. The commenter further asserted that the most logical and reasonable
reading of "activity" from PUD No. 1 is the activity subject to the permitting authority of the Federal
agency and recommended that EPA should clarify that only the activity subject to Federal permitting can
be included in the scope of certification, and that once the permitted activity concludes, the conditions
imposed by the water quality certification and the certification itself are no longer applicable.

A few commenters asserted that the scope of certification should be limited to the discharge associated
with the Federal license or permit, including one commenter who asserted that section 401 only applies to
discharges into navigable waters that may violate specific water quality provisions proximate to the
project at issue. One commenter stated that the scope should be limited to and defined in reference to the
Federal agency's authority granted from Congress, because it cannot act on conditions that are outside of
its authority. Another commenter asserted that the broad proposed scope of review could lead to
certification conditions that a Federal agency does not have the authority to implement.

A few commenters argued that the certification process should not provide certifying authorities an
opportunity to re-evaluate aspects of the project that have already been authorized. One of these
commenters asserted that the proposed definition would result in duplicative regulatory obligations and
recommended explicitly excluding review of any other permitted water management activities at a project

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site. A few commenters who have projects involving maintenance of flood control or water supply
infrastructure expressed concern over certifying authorities considering impacts of reservoirs or dams in
the activity as a whole because of possible impacts on flood control and water supply systems. One of
these commenters asserted that review should be limited to water quality impacts of the discharge
associated with the activity covered by the Federal permit, and not impacts associated with the original
construction or ongoing operation of the overall facility. One commenter suggested defining "activity" to
mean only those activities at the project site that are specifically authorized by the Federal license or
permit in question with the potential to affect water quality and exclude areas of the project that are
already permitted.

Agency's Response: EPA appreciates commenter input of an alternative approach to
defining "activity." After considering public comments, the statutory text, legislative
history, and prior Agency guidance, EPA finds that section 401 is not constrained to those
activities directly authorized by the Federal license or permit in question. See Section
IV.E.2.b of the final rule preamble for further discussion on the Agency's textual analysis,
the Agency's longstanding practice, and legislative history in support of this conclusion.

In response to comments regarding how a Federal licensing or permitting agency could
implement certification conditions addressing aspects of the activity that the Federal agency
does not otherwise have licensing or permitting authority over, see the Agency's Response
to Comments in Section 5.1.6.3.

EPA would like to clarify that a certification cannot alter an existing Federal license or
permit after its issuance; rather, the certification is incorporated into the relevant Federal
license or permit that triggered the need to request certification. See section IV.I of the final
rule preamble for discussion on modifications to granted certifications. However, EPA finds
that existing authorizations may be relevant to a certifying authority's analysis and
determination of whether a particular activity will comply with water quality requirements.
For example, existing authorizations may inform the baseline water quality conditions in a
waterbody and whether a certifying authority needs to add conditions to ensure the activity
will comply with water quality requirements.

5.1.6.2 Do Not Support Alternative Definition of Activity as a Whole

A few commenters did not support the Agency's possible alternative definition of "activity as a whole"
that EPA invited comment on. One commenter argued that it was unlawful and there was no basis in the
CWA to limit the scope to "only those activities at the project site that are specifically authorized by the
Federal license or permit in question." The commenter further asserted that such a definition would run
contrary to Congress' clear intent to give states and Tribes broad authority to review, condition, and deny
certifications and would have the same effect as the 2020 Rule's discharge-only approach for some
projects. Another commenter asserted that it was unnecessary for EPA to parse the "activity as a whole"
definition on narrow, jurisdictional grounds and that the entire project associated with the potential
discharge should be subject to the certification requirement to achieve the CWA's purpose.

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Agency's Response: See Section IV.E.2.b of the final rule preamble and the Agency's
Response to Comments in Section 5.1.6.1.

5.1.6.3	Authority Over a Small Part Question

A few commenters provided comments in response to EPA's request for comment on whether and how
the Federal licensing or permitting agency could effectively implement a certification with conditions that
address impacts from the "activity as a whole" if it has authority over only a small part of a larger project.
One commenter asserted that Federal agencies do not have the capability or processes to oversee
enactment of certification conditions for off-site actions or longer duration activities, which can lead to
liability issues, and encouraged EPA to work with Federal agencies on implementation issues. Another
commenter asserted that the bounds of Federal authority are irrelevant to the scope of state or Tribal
authority, observing that Section 401(d) requires the Federal agency to adopt whatever conditions the
state or Tribe includes to ensure compliance with the CWA and does not mention that the scope of those
conditions should depend on the scope of the Federal agency's authority over the project. One commenter
stated that in cases where the Federal agency would have authority over only a small part of a larger
project, the certifying authority and project proponent may sign an agreement to ensure offsite measures
would be implemented.

Agency's Response: EPA generally agrees with the commenter asserting that bounds of the
permitting authority of the Federal permitting agency does not dictate the scope of state or
Tribal authority under section 401. Section 401 requires the certification conditions to
become conditions of the Federal license or permit subject to certification, regardless of
whether the Federal agency has independent authority to condition its license or permit to
ensure compliance with water quality requirements. However, EPA emphasizes that—for
purposes of section 401—certification conditions cannot "live on" past the expiration of the
Federal permit to which they attach. Section 401(d) requires certification conditions to be
incorporated into the Federal license or permit. Accordingly, once the Federal license or
permit expires, any certification conditions incorporated into the Federal license or permit
also expire. This principle holds true regardless of the scope of section 401. However, it does
not mean that when a certifying authority considers whether to grant or deny certification,
the certifying authority is limited to considering only those aspects of the activity that will
occur before the expiration of the Federal license or permit. For example, if the certifying
authority determines that no conditions could assure that the activity, including post-
expiration aspects of the activity, will comply with water quality requirements, denial of
certification would be appropriate.

5.1.6.4	Hydroelectric Facilities Example

EPA received a few comments on the example in the proposal regarding two hydroelectric facilities,
Facility A and Facility B, which require different sets of permits. One commenter used the example to
express support for a broader interpretation of "activity as a whole" not limited to the activity regulated
by the Federal permit. The commenter noted that under a narrower approach to "activity as a whole" tied
to the permit at issue, for the certification of Facility B's NPDES permit, no consideration would be given

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to the water quality impacts of the construction and operation of the facility. The commenter continued
that review of the facility's operation impacts on protected uses such as aquatic propagation and survival
may be left out. Another commenter stated that while the certification for Facility B will apply only to the
prospective operation of the dam, it is possible that in order to comply with applicable water quality
requirements, the dam will be required to implement structural or operational modifications. Another
commenter stated that EPA's hydroelectric dam hypothetical does not account for circumstances in which
a Federal permit is temporary in nature. The commenter asserted that the FERC and NPDES permits in
the example are ongoing in nature, while a section 404 permit is finite and once the permitted activity is
complete, any certification conditions included in the section 404 permit are likely no longer in effect.

One commenter asserted that the hydroelectric dam example was irrelevant to many scenarios because,
unlike a hydroelectric dam, not all infrastructure projects require operating permits. The commenter
argued that once the "activity" that was the subject of the Federal permit is complete, it would be
inappropriate for the certifying authority to include any "adaptive management" conditions in the
certification because the certifying authority has no authority to impose late-arising conditions that spring
into effect at some point in the future.

Agency's Response: See Section IV.E.2.b of the final rule preamble and the Agency's
Response to Comments in section 5.1.6.

The Agency agrees that, for purposes of section 401, certification conditions cannot "live
on" past the expiration of the Federal permit to which they attach. Section 401(d) requires
certification conditions to be incorporated into the Federal license or permit. Accordingly,
once the Federal license or permit expires, any certification conditions incorporated into the
Federal license or permit also expire. This principle holds true regardless of the scope of
section 401 or the type of certification condition (e.g., adaptive management). However, it
does not mean that when a certifying authority considers whether to grant or deny
certification, the certifying authority is limited to considering only those aspects of the
activity that will occur before the expiration of the Federal license or permit. For example,
if the certifying authority determines that no conditions could assure that the activity,
including post-expiration aspects of the activity, will comply with water quality
requirements, denial of certification would be appropriate.

The Agency disagrees with commenter assertions that certifying authorities do not have the
authority to impose "adaptive management" conditions. This final rule does not allow
certifying authorities to unilaterally add new certification conditions after issuance of the
certification decision and/or the Federal license or permit. See Section IV.I for further
discussion on modifications to grants of certification. However, to be clear, the Agency does
not consider so-called "adaptive management" conditions to be unilateral modifications. See
Section IV.F for further discussion on adaptive management conditions. Like other
conditions, these conditions would also expire when the Federal license or permit expires.

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5.1.7 Who Should Define Activity

A few commenters asserted that states and Tribes should be able to define the "activity" they plan to
review. One of those commenters recommended amending proposed section 121.7 to allow states to
partially waive certification to exclude specific aspects of a project it deems as outside the scope of
review. Another commenter stated that certifying authorities should only consider project components for
which the certifying authority has authority. One commenter recommended that states should have the
discretion to decide whether or not to place conditions on impacts from nonpoint sources once the overall
activity has triggered the need for certification so states may implement the CWA in their state as they see
fit.

One commenter asserted that the Agency should address the question of how to define the activity as a
whole. To illustrate such need, the commenter discussed issues with section 404 projects (e.g., linear
projects) where the Corps treats each individual water body or wetland crossing as a separate project and
forces the certifying authority to limit their scope to that particular project. The commenter argued that
such a result does not allow a holistic review of water quality impacts, but rather end up where activity as
a whole and the point source discharges that trigger section 401 review are defined essentially the same
way.

Agency's Response: The Agency is not finalizing the proposed definition for "activity as a
whole," and instead will rely on clarifying edits in final rule section 121.3 to articulate the
activity subject to a certifying authority's review. Specifically, this final rule addresses
commenter concerns regarding regulatory certainty by clarifying important limiting
principles that inform delineation of the "activity" under review by the certifying authority
including that certifying authorities are limited to considering adverse impacts to water
quality from the activity subject to the Federal license or permit. In addition to these
clarifying edits, the Agency notes that certifying authorities and Federal agencies have
gained significant experience over nearly 50 years implementing an "activity" approach,
and EPA expects that certifying authorities and Federal agencies remain capable of
appropriately delineating the "activity" based on the facts of each situation. EPA is not
aware of and did not receive any comments identifying any cases in which delineation of
"activity" has been litigated, provided that the scope of review was limited to water quality.
See Section IV.E.2.b of the final rule preamble.

In response to the commenter asserting that states should have discretion to address (or not
address) impacts from nonpoint sources, the Agency notes that section 121.3(a) requires a
certifying authority to evaluate "whether the activity will comply with applicable water
quality requirements." Whether or not a certifying authority needs to add conditions to
address water quality impacts from nonpoint source aspects of the activity subject to the
Federal license or permit will depend on its water quality requirements and the water
quality-related impacts from the proposed federally licensed or permitted activity.

In response to the commenter recommending that states should be able to "partially waive
certification," EPA wishes to clarify that any attempt at a "hybrid" version of the four

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certification decisions identified at section 121.7(a) does not meet the standard of "acting"
on a request for certification (e.g., a waiver with conditions, a conditional denial). See
Section IV.F of the final rule preamble.

5.1.8 Other Arguments (Major Questions, Duplicative of NEPA, Fed Agency Impacts)

A few commenters asserted that the Agency's proposed scope was impermissible under the major
questions doctrine. One commenter asserted that EPA's request for comment on whether Federal agencies
could effectively implement certification conditions for the activity as a whole if they have authority over
only a small part of a larger project highlighted the weak legal foundation for the proposed scope and that
it was impermissible under the major questions doctrine. Another commenter asserted that EPA should
not assume that Congress hid vast state power in section 401(d), noting that the Supreme Court recently
held that "[extraordinary grants of regulatory authority are rarely accomplished through 'modest words,'
'vague terms,' or 'subtle device[s].'" West Virginia v. EPA, 142 S. Ct. 2587 (2022). The commenter
argued that EPA's proposed scope of review would rewrite Congress's balanced legislative language and
place certifying authorities in control of interstate projects.

A few commenters argued that the "activity as a whole" scope would duplicate the NEPA review process.
One commenter asserted that section 401 was intended to focus on specific discharges because of changes
made from section 21(b) to section 401 and section 401's relationship to NEPA. First, the commenter
argued that the changes made to Section 21(b) in the 1972 CWA amendments were intended to maintain
consistency with the amendments' broader focus on point source discharges to waters of the United
States. Second, the commenter further asserted that section 21(b) provided states with the authority to
examine the water quality impacts of Federal actions in the absence of any Federal obligation to consider
potential environmental impacts. However, according to the commenter, Section 401 followed passage of
NEPA, and when analyzed in that context, Congress did not intend section 401 to duplicate NEPA's
processes in scope, scale, or duration.

A few commenters discussed the impact of the proposed scope on other Federal agencies or in the context
of the Federal licensing or permitting process. One commenter argued that EPA's proposed scope of
certification would create a situation where the scope of the certifying authority's review is broader than
the scope of the Federal authorization that triggered the review, which the commenter asserted would be
an impracticable and unlawful result. Another commenter asserted that the proposed scope would expand
section 401 certification condition enforcement by Federal agencies to land and water resources more
appropriately subject to state authority. One commenter asserted that EPA's interpretation of the scope of
certification lacked any reasonable consideration of the broader licensing and permitting context within
which certification is a part. The same commenter asserted that EPA incorrectly stated that section 401 is
the only means for states and Tribes to address concerns regarding potential environmental impacts of
Federal projects and argued that section 401 allows states and Tribes to protect their water quality in the
context of the permitting process that otherwise would preempt state or Tribal authority.

A few commenters discussed perceived consequences of the activity as a whole scope. One commenter
argued that the "activity as a whole" scope would cause facilities that obtain EPA-issued NPDES permits
to be treated unequally in comparison to facilities that obtain state or Tribal issue NPDES permits,

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because they will be subject to burdensome certification conditions on nonpoint source discharges that are
more appropriately considered through a TMDL. Another commenter argued that the proposed scope may
cause significant and unmitigable water supply losses and invite litigation.

A few commenters asserted that the proposed scope of certification would implicate the commerce clause
when certifying authorities review projects that are interstate in nature. One commenter asserted that the
scope would create unnecessary conflict between states and create dormant commerce clause concerns in
which the laws of one state impermissibly dictate the economic activity of another state. The commenter
argued that the activity as a whole scope of review would allow states with little relation to the main
project to harm the land and water priorities of another state.

One commenter said that they are concerned about the use of the guidance document, Wetlands and 401
Certification: Opportunities and Guidelines for States and Eligible Indian Tribes (April 1989) ("1989
Guidance"). The commenter further said that the guidance document was outsourced and in part written
by an activist.

Another commenter stated that some states are prohibited from evaluating a project's "activity as a
whole."

Agency's Response: EPA disagrees that this rulemaking represents one of the
"extraordinary cases" that implicates the major questions doctrine. West Virginia v. EPA
142 S. Ct. 2587, 2609 (2022). First, while the doctrine concerns instances where an agency
"claim [ed] to discover in a long-extant statute an unheralded power," id. at 2610 (internal
cite omitted), the scope of certification adopted in this final rule is far from "unheralded"—
it realigns with 50 years of accepted practice squarely upheld by the Supreme Court in PUD
No. 1. This final rule restores the scope of certification affirmed by the Supreme Court in
PUD No. 1 over a quarter of a century ago and realigns the Agency's interpretation of scope
with all of its previous interpretations, some dating from the 1980s. Second, section 401 is
hardly an "ancillary provision" or "little-used backwater" of the CWA, nor was it
"designed to function as a gap filler" that "had rarely been used in the preceding decades."
See id. at 2610, 2613. Section 401 certification is a well-established tool for states to protect
their water quality from Federally licensed and permitted projects. EPA estimates that
certifying authorities receive 77,000 certification requests annually. See ICR Supporting
Statement. Additionally, while the doctrine stems from "separation of powers principles"
and addresses the relationship between Congress and a Federal administrative agency
"asserting highly consequential power" for itself, id at 2609, this final rule generally
concerns the authority of states and Tribes, not EPA.4 Nor is EPA asserting authority, for
itself or for certifying authorities, to make policy judgements similar to what the Court
found problematic in West Virginia v. EPA. Id. at 2596 (criticizing EPA's interpretation as
allowing the agency to take on a role typically left for Congress in "balancing the many vital
considerations of national policy implicated in deciding how Americans will get their

4 Although EPA does act as a certifying authority when no state or Tribe has authority to certify, such
instances are the exception, not the norm.

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energy"). Instead, under the final rule, certifying authorities are limited to considering
water quality-related impacts from the activity subject to the Federal license or permit, and
not broader policy implications. Finally, the final rule's interpretation of scope hardly
represents a major question "of such economic and political significance" or
"unprecedented power over American industry" that necessitates clear congressional
authorization. Id. at 2612-13. Instead, the economic impacts of the final rule are expected to
be minimal, as it codifies many existing practices that have been widely implemented over
the last 50 years or more and adds further clarity on several key issues. See the Final Rule
Economic Analysis.

The Agency disagrees with commenters asserting that an activity-based scope would
duplicate the NEPA review process. The environmental review required by NEPA has a
much broader scope than that required by section 401 or this final rule. For example, the
NEPA review evaluates potential impacts to all environmental media. By comparison, the
activity-based scope adopted in this final rule is appropriately bounded so that certifying
authorities may only consider adverse impacts to waters that prevent compliance with
water quality requirements. Section 401 also authorizes certifying states and Tribes to add
conditions to a Federal license or permit, or even prohibit its issuance, if that is what is
required to assure compliance with water quality requirements. NEPA affords states and
Tribes no such similar authority. Therefore, for those Federal licenses or permits that are
subject to both NEPA and CWA section 401, both NEPA review and section 401
certification serve important—but distinct—roles in Federal licensing and permitting
processes.

In response to the commenter assertions regarding the impact of the scope of certification
on Federal agencies, see generally Section 5.1 of the Agency's Response to Comments. The
Agency also disagrees that section 401 is limited to only allowing states and tribes to protect
their water quality where the Federal licensing or permitting process would otherwise
preempt state or tribal authority. Both the plain text of section 401 and the legislative
history make clear that any federally licensed or permitted activity that may result in any
point source discharge into waters of the United States is subject to section 401. See Section
III of the final rule preamble. Nowhere in the statutory text nor legislative history did
Congress state or imply that section 401 was limited in the manner suggested by the
commenter.

In response to commenters' perceived consequences of the "activity" scope of certification,
EPA observes that commenters did not provide evidence to substantiate alleged impacts or
harms (e.g., "significant and unmitigable water supply losses"). Indeed, the final rule
codifies many existing practices that have been widely implemented over the last 50 years
and adds further clarity on several key issues in response to commenter input, which should
mitigate the potential for any negative impacts from implementing this final rule.

In response to commenters asserting that EPA's interpretation regarding the scope of
certification would implicate the dormant Commerce Clause, EPA notes that Supreme

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Court case law regarding the dormant Commerce Clause concerns actions taken by states
(or localities) under state (or local) law, and considers whether these actions impermissibly
discriminate against interstate commerce or impose an "undue burden" on such commerce.
See S. Dakota v. Wayfair, Inc., 138 S. Ct. 2080, 2089-91 (2018). The Supreme Court's
dormant Commerce Clause jurisprudence is not applicable to actions taken by the Federal
government—including this rulemaking—regardless of whether the Federal actions
regulate actions of states that may themselves be subject to dormant Commerce Clause
jurisprudence. Lake Carriers Association v. EPA, 652 F.3d 1, 9 (D.C. Cir. 2011) (explaining
that "[djormant Commerce Clause doctrine applies only to burdens created by state law,"
not "a federal statute [such as] the CWA, and a federal regulation") (emphasis in original).

Actions taken by states pursuant to section 401 are not insulated from dormant Commerce
Clause challenges. Lake Carriers, 652 F.3d at 10 (internal citations omitted) ("If [petitioners]
believe that the certification conditions imposed by any particular state pose an inordinate
burden on their operations, they may challenge those conditions in that state's courts. If
[petitioners] believe that a particular state's law imposes an unconstitutional burden on
interstate commerce, they may challenge that law in federal (or state) court."). Whatever
interpretation of scope that EPA adopts in this rulemaking does not change the fact that
state actions taken under section 401 could theoretically implicate the Court's dormant
Commerce Clause jurisprudence. For example, regardless of the scope of certification, a
state cannot discriminate against interstate commerce in violation of the dormant
Commerce Clause when acting on a request for certification. If a project proponent
believes that a certifying authority acted on a request for certification in a way that violates
dormant Commerce Clause jurisprudence, it may assert such a challenge in court. EPA
notes that most certification decisions are issued without controversy. EPA is aware of only
a single challenge to a state action taken pursuant to section 401 alleging dormant
Commerce Clause violations, and that challenge never reached the merits. Millennium Bulk
Terminal and Lighthouse Resources, Inc. v. Inslee, No. 3:18-cv-5005, Complaint at ff206-
210; ff224-248 (W.D. Wash, filed Jan. 8, 2018).

In response to commenter assertions regarding the 1989 Guidance, the Agency notes that
the commenter provided no further discussion or evidence to substantiate concerns
regarding the guidance's content or authors. Nevertheless, the Agency emphasizes that the
"activity" scope of certification in this final rule is not only consistent with longstanding
Agency guidance, but also, more importantly, the statutory language, Congressional intent,
and authoritative Supreme Court case law. See Section IV.E for further discussion on the
final rule's scope of certification and analysis.

In response to the commenter asserting that some states are prohibited from evaluating the
"activity" scope of certification, the Agency notes that section 121.3(a) requires a certifying
authority to evaluate "whether the activity will comply with applicable water quality
requirements." Whether or not a certifying authority needs to place conditions on impacts
from the activity will depend on its water quality requirements and the water quality-
related impacts from the proposed Federally licensed or permitted activity. However, as

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discussed in Section IV.E of the final rule preamble, EPA has concluded that the best
reading of the statutory text is that the scope of certification is the activity subject to the
Federal license or permit, not merely its potential point source discharges. This reading is
further supported by the legislative history of section 401, authoritative Supreme Court
precedent, and the goals of section 401, which include recognition of the central role that
states and authorized Tribes play in protecting their own waters.

5.2 Water Quality-Related Effects and Requirements

5.2.1 Whether the Scope of Certification Should Extend Beyond Water Quality

The overwhelming majority of commenters agreed that the scope of section 401 certification is limited to
water quality. Many commenters asserted that the scope of certification should not extend beyond impacts
to water quality and/or water quality provisions. Several commenters argued that certifying authorities
have limited power under CWA section 401 to consider anything beyond water quality. These
commenters asserted that section 401 does not authorize EPA or other regulators to impose conditions on
permits and licenses that pertain to matters other than water quality. One of these commenters argued that
Congress intended for Section 401 to focus exclusively on the potential water quality impacts from point
source discharges of proposed federally licensed or permitted projects, citing S. Rep. No. 92-414, at 69
(1971). Another commenter stated that case law demonstrates that it is impermissible under the CWA and
other statutes assigning decision-making authority to Federal agencies for a certifying authority to use
section 401 authority to hold the Federal licensing process hostage or to base its certification decision on
policy considerations that cannot be credibly construed as addressing concerns over water quality
impacts. One commenter noted that EPA has consistently taken the position that the scope of certification
is limited to potential water quality-related effects and urged the Agency to retain its position.
Commenters provided general examples of what they deemed as non-water quality impacts, including as
air quality impacts, local traffic patterns, economic impacts, political issues, and noise.

Conversely, one commenter argued that EPA inappropriately limited the scope of certification to aspects
of the activity that have the potential to affect water quality without any meaningful analysis and asserted
that the CWA and PUD No. 1 require certifying authorities, and not EPA, to determine the appropriate
scope of authority.

Several commenters expressed concern that the proposed scope of certification would enable certifying
authorities to deny or condition projects for non-water quality related reasons or for water quality
considerations that are not appropriate under section 401. One commenter asserted that the proposed
scope of certification will encourage a return to improper, non-water quality-related conditions, such as
including payments for improvements unrelated to the proposed project or associated with air emissions
and transportation effects. Another commenter asserted that the Agency's primary factor for proposing
the activity as a whole scope was to allow states to include the effects of climate change to water quality
resulting from the lifetime operation of a project and claimed this would allow states to improperly use
the CWA to deny projects on shaky hypothetical assumptions. One commenter asserted that the proposed
rule's Economic Analysis illustrated "mission creep" from the activity as a whole approach and argued
that consideration of water quality-related impacts of a large pipeline project, such as erosion and

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sedimentation, were not the purpose of section 401. One commenter argued that the CWA does not allow
states and Tribes to use section 401 as a catch all to evaluate any potential environmental impacts that
theoretically could impact some waters at some point or to pursue state environmental goals unrelated to
water quality. Another commenter asserted that the scope should be limited to water quality concerns and
not the activity as a whole.

A few commenters argued that other Federal and state statutes and regulations allow certifying authorities
to address non-water quality related issues. One commenter asserted the existence of these other avenues
to address non-water quality impacts demonstrates that certifications are not the proper mechanism to
address potential environmental impacts beyond water quality. Another commenter argued that states
should not deny certification based on non-water quality issues evaluated in a separate state
environmental quality review, while another commenter asserted that there is nothing in section 401 that
prevents states from addressing these issues under state law instead. A different commenter argued that
incorporating non-water quality issues into the certification process is duplicative of Federal reviews
under NEPA for the same activity, while another commenter argued that expanding the scope of
certification beyond water quality concerns risks inviting duplication and conflict with other regulatory
compliance efforts, such as section 7 of the Endangered Species Act. A few commenters argued that
interpreting section 401 to include non-water quality conditions would interfere with FERC's exclusive
licensing authority. One of these commenters argued that courts have found certifying authorities may
only consider matters related to their water quality standards when certifying FERC licensed-projects
(citing Mohawk Power Corp. v. DEC, 624 N.E.2d 146, 149-50 (N.Y. 1993); Power Auth. v. Williams, 60
N.Y.2d 315, 325 (N.Y. 1983)).

Agency's Response: As discussed in Section IV.E.2.C of the final rule preamble, a certifying
authority's review must be limited to the water quality-related impacts from the activity. It
would be inconsistent with the purpose of CWA section 401 to deny or condition a section
401 certification based on potential impacts that have no connection to water quality (e.g.,
based solely on potential air quality, traffic, noise, or economic impacts that have no
connection to water quality). Accordingly, EPA strongly disagrees that this final rule would
permit certifying authorities to consider non-water quality-related factors as the basis for a
certification denial or condition. The scope of certification is limited to adverse water
quality-related impacts from the activity. That said, water quality-related impacts can
encompass impacts that adversely affect the chemical, physical, and biological integrity of
waters, which could include, for example, changes in water flow that might affect aquatic
habitat. As discussed in Section IV.E.2.C of the final rule preamble, the Agency finds that a
multi-faceted interpretation of water quality-related impacts represents the best
interpretation of section 401 and best allows certifying authorities to realize the water
quality protection goals of the CWA and section 401.

The Agency disagrees with the commenter asserting that the Agency inappropriately
limited the scope of certification without any meaningful analysis or that either the CWA or
PUD No. 1 require certifying authorities to determine the scope of authority. When
Congress gave certifying authorities the ability to review any activity subject to a Federal
license or permit that may result in a discharge into waters of the United States, it added a

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key limiting principle to that otherwise broad authority—the review is limited to
determining compliance with water quality requirements. See Section IV.E.2.C for further
discussion on Congressional intent, judicial interpretation, and EPA interpretation on the
water quality limitations in section 401.

EPA disagrees with commenter assertions that the Agency's primary factor for proposing
the "activity" scope of certification was to allow states to consider the effects of climate
change to water quality. Rather, the Agency proposed and is finalizing the "activity" scope
of certification because EPA has concluded that the best reading of the statutory text is that
the scope of certification is the activity subject to the Federal license or permit, not merely
its potential point source discharges. This reading is further supported by the legislative
history of section 401, authoritative Supreme Court precedent, and the goals of section 401.
See Section IV.E of the final rule preamble and the Agency's Response to Comments in
Section 5.1. Similarly, EPA disagrees that the "activity" scope of certification would allow
states to improperly use the CWA to deny projects on "shaky hypothetical assumptions" or
"potential environmental impacts that theoretically could impact some waters at some
point" related to climate change or otherwise. However, Agency also finds it unnecessary to
establish in this rulemaking how indirect or certain the impacts of the activity may be to
water quality. It is incumbent on the certifying authority to develop a record to support its
determination that an activity will or will not comply with applicable water quality
requirements. If a project proponent believes the certification decision is premised on
"shaky hypothetical assumptions," it may challenge the sufficiency of the decision in a court
of competent jurisdiction. This outcome is consistent with Congressional intent. The
legislative history reveals that Congress intended project proponents to seek relief in state
courts in instances where it disagreed with a certification decision. See, e.g., 116 Cong. Rec.
8805, 8988 (1970) (Conf. Rep.) ("If a State refuses to give a certification, the courts of that
State are the forum in which the applicant must challenge that refusal if the applicant
wishes to do so."); H.R. Rep. No. 92-911, at 122 (1972) (same).

The Agency disagrees with the commenter asserting that certifying authorities are limited
to only considering matters related to their water quality standards when certifying FERC
licensed-projects. Rather, for all Federal licenses or permits subject to certification,
certifying authorities must evaluate whether the activity will comply with applicable all
water quality requirements, which include, but are not limited to, water quality standards.
33 U.S.C. 1341(a), (d); 40 CFR 121.3. See Section IV.E.2.C for further discussion on the term
"water quality requirements."

5.2.2 Clearly Limiting Scope of Review to Water Quality

A few commenters recommended that the rule should clearly state that the scope of review is limited to
activities that may affect water quality, while another commenter suggested that the Agency should add
express language that a certifying authority may not include non-water quality conditions or conditions
that would extend the reasonable period of time beyond one year. One of these commenters suggested
that the regulations should clearly state what is within and outside the scope of review and asserted that

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case law establishes that the scope is limited, quoting American Rivers v. FERC, 129 F.3d 99, 107 (2d
Cir. 1997) ("Section 401(d), reasonably read in light of its purpose, restricts conditions that states can
impose to those affecting water quality in one manner or another."). Another commenter asserted that
many courts have recognized the need to constrain the types of conditions states can impose under section
401 to those necessary to protect water quality, citing federal and state case law. The commenter also
noted that FERC has often noted that conditions unrelated to a project's activity are not proper section
401 conditions.

Another commenter recommended that the Agency clarify that certification conditions must include
specific conditions based on review of actual and site-specific information of the water quality impacts of
the proposed project and asserted that EPA must clarify that a condition that requires a project proponent
to obtain required state water quality permits is inconsistent with Section 401. The commenter asserted
that conditions that direct the project proponent to receive other necessary permits is insufficient to
protect water quality and undermine the purpose of the CWA because the certifying authority is not
completing any further analysis and granting certification if the project meets previously instituted
requirements.

Another commenter asked the Agency to list all permissible categories of requirements that states may
rely upon to issue certifications in regulation. One commenter asserted that the proposed rule would allow
pre-2020 Rule scope creep issues to reemerge because the proposal does not explicitly define issues that
are outside the scope.

Another commenter asserted that even under the "activity as a whole" scope, any conditions must
exclusively and directly relate to water quality standards to be consistent with the plain language of
section 401 and restrain certifying authorities from blocking projects for reasons unrelated to water
quality.

Agency's Response: The scope of certification is limited to adverse water quality-related
impacts from the activity. See the Agency's Response to Comments in Section 5.2.1. The
Agency does not feel it necessary or appropriate to specifically list each possible activity or
impact that is within or out of the scope of review, or each category of water quality
requirements a certifying authority may rely upon. The Agency revised its explanation of
the "activity" approach from proposal to provide more clarity. Although each
determination will be fact specific, the Agency is clarifying important limiting principles
that inform delineation of the "activity" under review by the certifying authority. The
Agency finds that its approach to "activity" in this final rule is appropriately bounded to
allow certifying authorities to only consider adverse impacts to waters that prevent
compliance with water quality requirements. The final text at section 121.3 also makes it
clear that the analysis is limited to the applicant's activity subject to the Federal license or
permit at issue (and to considering that activity's adverse impacts on water quality). See
Section IV.E.2.b for further discussion on the limiting principles in the final rule's scope of
certification.

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Relatedly, the Agency is adding text at section 121.3(b) to clarify that the scope of review for
a certification decision is the same as the scope of permissible conditions that may be added
to that certification. See Section IV.E.2.e of the final rule preamble. The Agency declines to
explicitly identify which conditions would be within or outside the scope of section 401
certification because, subject to a case-by-case review of the particular facts presented by
each certification, a wide variety of conditions could be appropriate as necessary to prevent
adverse impacts to a state's or Tribe's water quality. While the final rule preamble provides
some examples of non-water quality-related conditions that would generally be beyond the
scope of section 401, the appropriateness of any given condition will depend on an analysis
of all relevant facts, including the certifying authority's applicable water quality
requirements. For potentially qualifying conditions, it is appropriate for the certifying
authority to consider all potential adverse water quality impacts. See Section IV.E.2.C and
Section IV.E.3 for further discussion in response to these commenters.

The Agency disagrees with the commenter asserting that any conditions must exclusively
and directly relate to water quality standards. Consistent with the statutory text, this final
rule requires certifying authorities to consider whether the activity will comply with water
quality requirements, which includes but is not limited to water quality standards. See
Section III for further discussion on the textual changes from Section 21(b) to Section 401,
and Section IV.E for further discussion on the term "water quality requirements."

5.2.3 Experience With Non-Water Quality Factors

Several commenters asserted that certifying authorities considered non-water quality factors prior to the
2020 Rule and provided examples of such factors and the asserted consequences, including project delays,
ambiguity, and undue burden on project proponents. One commenter provided examples of certification
conditions from before the 2020 Rule that the commenter asserted had little or nothing to do with water
quality effects of the certified project, including conditions addressing terrestrial or aquatic wildlife issues
unrelated to project effects on water quality (e.g., support a feral hog task force and allow state access to
the project area to trap and kill feral hogs), conditions requiring enhancements to public recreational
opportunities and facilities unrelated to project effects on water quality (e.g., make annual payments for
maintaining and enhancing public recreational facilities on non-project lands), and conditions wholly
unrelated to project effects on water quality. Another commenter asserted that states looked at all direct
and indirect impacts of the proposed activity on any and all state interests and non-water quality impacts.
The same commenter asserted that pre-2020 Rule practice allowed states to engage in de facto regulation
of rail transportation, interstate and foreign commerce, and asserted that the proposed rule would allow
negative impacts on infrastructure projects, particularly in the rail industry.

A few commenters asserted that a handful of states have attempted to block or constrain projects based on
non-water quality reasons, including one commenter who asserted that states have misused section 401 to
block pipeline projects. Another one of these commenters asserted that certain certifying authorities used
ambiguities between the 1971 Rule and the 1972 CWA to abuse their certification authority for the
purpose of delaying or denying certifications on non-water quality grounds. A few commenters discussed
specific certification actions that they asserted demonstrated "state abuse" of section 401, including

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Washington's denial of certification for the Millennium Bulk Terminal, arguing that Washington denied
certification of the project for non-water quality related political reasons; New York's denial of
certification for the Valley Lateral Pipeline, arguing it was unrelated to water quality; and a project in
Maryland where, according to the commenter, the state sought a multi-billion dollar payment-in-lieu of
imposing unachievable conditions unrelated to the discharge.

Conversely, one commenter argued that prior to the 2020 Rule, the vast majority of certifications were
issued promptly, and asserted that some project applicants and lobbyist incorrectly claimed that states
were abusing section 401 following the certification denials on high profile projects. The commenter
argued that the denials in question were based on water quality, citing several high-profile projects,
including Mountain Valley Pipeline, Millennium Valley Lateral, Constitutional Pipeline, and Millennium
Bulk Terminal.

Several commenters discussed the possible consequence of allowing certifying authorities to consider
non-water quality related concerns, including project delays, ambiguity, and undue burden on project
proponents. A few commenters asserted that states had required project proponents to provide
documentation wholly unrelated to water quality, such as EAs of impacts to other environmental media,
demonstrations of the need for the project, alternative route analyses, and analyses of air impacts, traffic
impacts, and other reviews undertaken by FERC or other Federal agencies pursuant to the NEPA, the
ESA, and the NGA. One commenter asserted that certifying authorities require non-water quality
administrative requirements in requests for certification or place such conditions on certifications that
ultimately delay and disrupt infrastructure planning. The same commenter provided various examples,
including requiring proof of acquisition of all necessary real property rights for the entire project, and
objecting to FERC-approved construction methods for water and wetlands crossings.

A few commenters focused specifically on certification actions related to climate change. One commenter
stated that some states have used section 401 certifications to try and address direct and indirect effects
associated with projects (e.g., global warming and social impacts) that are unrelated to CWA permitting
and water quality requirements. Another commenter asserted that climate change and greenhouse gas
emissions are not water quality issues and that allowing denials, or certification conditions based on
climate change would be inconsistent with statutory authority, citing West Virginia v. EPA, 142 S. Ct.
2587 (2022). The commenter also argued that the proposed rule would permit certifying authorities to
reject fossil fuel-related projects with no serious water quality concerns.

Agency's Response: The Agency appreciates commenter input regarding experiences pre-
2020 Rule. For the reasons described in Section IV.E.2.C of the final rule preamble, a
certifying authority's review must be limited to the water quality-related impacts from the
activity. It would be inconsistent with the purpose of CWA section 401 to deny or condition
a section 401 certification based on potential impacts that have no connection to water
quality (e.g., based solely on potential air quality, traffic, noise, or economic impacts that
have no connection to water quality). Accordingly, EPA strongly disagrees that this final
rule would permit certifying authorities to consider non-water quality-related factors as the
basis for a certification denial or condition. See Section IV.E for further discussion on water

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quality-related impacts from federally licensed or permitted projects; see also the Agency's
Response to Comments in Section 5.2.1, 5.2.2.

5.3 Definition of Water Quality Requirements (WQR)

5.3.1 Support for Proposed Water Quality Requirements Definition

Many commenters supported the proposed approach to "water quality requirements," including its
inclusion of requirements related to point and nonpoint sources, noting it is more holistic, consistent with
the Act and its purpose, consistent with case law, and restores and reinforces the authority Congress
reserved for states and Tribes. One commenter supported the proposed definition's explicit recognition of
state water quality requirements because it provides clarity and promotes efficiency for projects reviewed
under section 401 and other related state regulations (i.e., the state can take an integrated approach to
review), reducing application processing time. Similarly, another commenter reflected on the flexibility
the proposed definition, asserting that it would allow the commenter's state to work with project
proponents to develop conditions that balance water quantity and quality issues. Another commenter
noted that it would increase implementation clarity because it would avoid arguments about the nexus
between the discharge and the impact. One commenter stated that the Agency's proposed approach to
water quality requirements was consistent with the way the Supreme Court explained the law in the 1994
decision.

Several commenters discussed the importance of certifying authorities being able to protect their waters
from a wide range of impacts. One commenter asserted that the term "other appropriate requirements of
state law" is intended to be broad so states and Tribes can allow for things like access to waters for fishing
or recreation, monitoring of certain water conditions, and compensatory mitigation to help protect certain
designated uses. Another commenter argued that states and Tribes must be given broad discretion to
determine what factors they consider in evaluating whether certification under Section 401 is appropriate
and noted that the preamble rightly recognized that this definition must include review of a wide range of
impacts, including a project's potential to affect designated uses, such as recreation, or alter the chemical,
physical, and biological integrity of waterways. Another commenter argued that climate change highlights
the need for states and Tribes to have strong authority to protect their waters. A commenter said that
water quality impacts from the larger project in general or the activity as a whole might occur in waters at
some distance from the triggering discharge, and the commenter further stated that the proposal correctly
interprets "other appropriate requirements of state law" to include point and nonpoint discharges.

A few commenters reflected on the 2020 Rule's definition for water quality requirements, arguing that it
was unlawful, and in direct contravention of PUD No. 1,S.D. Warren, and section 401(d). One of these
commenters noted that the proposed rule would allow the certifying authority to use a certification to
address water quality impacts that would not occur without issuance of the Federal permit or license, such
as impacts to groundwater, impacts to isolated surface waters, impacts from structural changes to
waterways, or impacts from non-point sources. A few commenters asserted that the 2020 Rule's approach
to water quality requirements impeded certifying authority ability to impose conditions that protect water
quality, such as standards for erosion and sedimentation control, stormwater management, endangered
species protection, minimum in-stream flows, prevention of aquatic habitat loss, and prevention of

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groundwater contamination. A few commenters stressed the importance of this authority for FERC
licensed projects in particular because of their length and preemption. Another commenter noted that the
2020 Rule approach conflicted with the commenter's state laws, regulations, and water quality
management program. Another commenter argued that the CWA, its legislative history, the 1971 Rule,
and prior EPA guidance documents did not suggest that Congress intended to limit the scope of point
source discharges into waters of the United States, and further argued that PUD No. 1 expressly rejected
this position.

One commenter recommended that EPA should expressly reaffirm that water quality requirements
capture all three components of water quality standards (i.e., designated beneficial uses, water quality
criteria, and antidegradation policy), noting that some Federal agencies and project proponents have
viewed conditions to achieve these components with skepticism despite the plain text of the Act (citing
letter from EPA to FERC, Jan. 18, 1991). Another commenter noted that inclusion of water quality
standards, as opposed to just numeric criteria, is necessary to meet the primary objective of the Act. One
commenter recommended that EPA should add clarifying language to the end of the proposed definition
for "water quality requirements" to say "with such state or tribe determining which of its laws are water
quality-related" to accommodate complementary state and Tribal policy goals and affirm Tribal and state
sovereignty.

One commenter stated that the proposed rule would allow states to include certification conditions similar
to those at issue in PUD No. 1, i.e., instream flow requirements, which the 2020 Rule made a departure
from.

Agency's Response: In finalizing the definition of "water quality requirements" as
proposed, the Agency has reconsidered the 2020 Rule's definition of the term and finds that
section 401 is best interpreted in a way that respects the full breadth of the Federal and
state and Tribal water quality-related provisions that Congress intended a certifying
authority to consider when determining whether to grant certification. Accordingly, EPA is
defining "water quality requirements" to include any limitation, standard, or other
requirement under the provisions enumerated in section 401(a)(1), any Federal and state or
Tribal laws or regulations implementing the enumerated provisions, and any other water
quality-related requirement of state or Tribal law regardless of whether they apply to point
or nonpoint source discharges. See 40 CFR 121.l(j). See Section IV.E.2.C of the final rule
preamble for further discussion and response to comments.

See also the Agency's Response to Comments in Section 5.3.2, 5.3.3.

5.3.2 Do Not Support Proposed Water Quality Requirements Definition

5.3.2.1 Proposed Definition of Water Quality Requirements is Too Broad or Too Narrow

Some commenters did not support the proposed definition for "water quality requirements" and asserted
that it was too broad and ill-defined. One commenter asserted that the Agency did not explain why it
changed its position on the definition of "water quality requirements," asserting that the proposal did not

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explain what it means to be "water quality-related" or "state or Tribal law" and claimed that the proposal
purposefully precluded any possibility of establishing regulatory certainty. Another commenter asserted
that inclusion of the term "any" was ambiguous and may be interpreted to denote "oneness" as opposed to
"plurality." Accordingly, the commenter suggested removing the term any and retaining the 2020 Rule
definition of water quality requirements. Another commenter argued that that the proposed definition
would allow certifying authorities to include non-water quality standards, which would amount to a
rewriting of the CWA cooperative federalism language, citing West Virginia v. EPA, 142 S. Ct. 2587
(2022). One commenter argued that the proposal's expansion to include "any other water quality-related
requirement of state or Tribal law" is not supported by the statute, separates the connection with
applicable provisions of the CWA, and does not set enough bounds on state authority.

Conversely, several commenters asserted that the proposed definition of "water quality requirements" was
overly restrictive. Another commenter asserted that EPA was adding a limit to section 401(d) that does
not exist and, assuming Congress said what it means, EPA cannot define what is "appropriate," citing US
v. Lopez, 998 F.3d 431, 441 (9th Cir. 2021).

Agency's Response: EPA disagrees that the final rule's definition for "water quality
requirements" is too broad or too narrow. As discussed in Section IV.E.2.C of the final rule
preamble, EPA finds that the text, purpose, and legislative history of the statute support the
final definition of "water quality requirements," which appropriately allows certifying
authorities to certify compliance with the enumerated provisions of the CWA and state and
Tribal water quality-related provisions (for both point and nonpoint sources). See Section
IV.E.2.C and IV.E.3 of the final rule preamble for further discussion, including the Agency's
interpretation of the term "any other appropriate requirements of state law"; see also the
Agency's Response to Comments Section 5.3.2.2-5.3.2.4.

In response to the commenter asserting that because the proposal did not explain what it
means to be "state or Tribal law," this precluded any possibility of establishing regulatory
certainty, EPA disagrees. EPA is not offering an opinion in this rulemaking about what
constitutes a "State law" as that term is used in section 401(d). In the spirit of cooperative
federalism, EPA defers to the relevant state and Tribe to define which of their state or
Tribal provisions qualify as appropriate "State law" or Tribal law for purposes of
implementing section 401. However, this does not preclude any possibility of regulatory
certainty. EPA is not aware of any controversy over this question that would require
rulemaking action. EPA is not aware of any litigation or other dispute regarding whether a
state or Tribal provision was sufficiently "legal" in nature to constitute a "law" that may
inform a certification decision. Moreover, the 2020 Rule defined this term to mean state or
Tribal "regulatory requirements," which hardly offers additional certainty.

In response to the commenter suggesting that water quality requirements should be limited
to compliance with water quality standards, the Agency disagrees. Rather, consistent with
the statutory text, this final rule requires certifying authorities to consider whether the
activity will comply with water quality requirements, which includes but is not limited to
water quality standards. See Section III for further discussion on the textual changes from

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Section 21(b) to Section 401, and Section IV.E for further discussion on the term "water
quality requirements."

5.3.2.2 Issues with the Term "Water Quality-Related"

A few commenters asserted that the term "water quality-related" was too broad and would allow
certifying authorities to include conditions unrelated or weakly related to water quality. Similarly, another
commenter argued that the term "water quality-related" goes beyond "water quality." Another commenter
argued that the use of "any water quality-related requirement" was circular and overly broad because it
would include conditions not related to the chemical, physical, or biological integrity of water, while
another commenter argued that it would allow states to include conditions on purely speculative or
obscure impacts. A few commenters asserted that the proposed rule would allow certifying authorities to
condition or deny projects as long as there is a nexus to water quality, which commenters argued would
allow states to block projects for non-water quality reasons. Another commenter asserted that the proposal
would allow for speculative concerns and argued that states could claim anything without ever showing
any concrete threat to water quality. One commenter suggested replacing "water quality-related
requirements" with "water quality requirements" to make it less broad.

A few commenters asserted that certifying authorities should demonstrate that water quality concerns are
likely to occur. One commenter also requested that EPA require certifying authorities to demonstrate a
strong likelihood of significant threats to water quality and that a non-water quality reason is not
influencing the decision.

A few commenters discussed possible implementation challenges associated with the term "water quality-
related," including asserting that it would delay projects, lead to uncertainty in implementation, and be
more expensive. One commenter asserted that it would add considerable expense to urban water providers
and result in significant water losses. Another commenter argued that it would be challenging for a
Federal agency to implement or enforce water quality-related conditions.

Conversely, a few commenters asserted that the term "water quality-related" was too restrictive and
recommended removing the term "water quality-related" in the definition for water quality requirements.
One commenter who agreed that the scope of certification is properly limited to water quality asserted
that certifying authorities should be able to consider impacts that are tangential to the discharge that can
have significant effects on water quality. Another commenter argued that EPA must allow certifying
authorities to impose any and all conditions that may be necessary to prevent adverse impacts to the
certifying authority's water quality, even if the water quality benefit of the condition is secondary or
incidental. One commenter expressed concern that the term could limit certifying authorities from
including conditions on procedural matters, like public access and fish passage. Another commenter
expressed concern over the list of conditions the preamble said would be out of scope, arguing that
certifying authorities are in the best position to determine what conditions will protect their water quality
and asserted that EPA should not prejudge the outcome. One commenter requested that the Agency
explicitly provide in regulation that certifying authorities can impose any conditions for which there is
any discernable water quality benefit, even if the condition principally addresses non-water quality related
impacts. Another commenter asserted that there are certain types of impacts that some may interpret as

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non-water quality related that are water quality related, such as land use conversion and tree removal. One
commenter asserted that in its state, certification requests may require public interest evaluations which
include water quality requirements and non-water quality related considerations. The commenter
recommended replacing the term "water quality-related" with "certification." One commenter asserted
that the phrase is improperly restrictive and recommended that the Agency use the term "any other
appropriate requirement" consistent with section 401(d).

Agency's Response: The Agency disagrees with commenter assertions that the term "water
quality-related" is overly broad or restrictive. The wording that Congress used in the text of
section 401 demonstrates that the certifying authority's review is limited to water quality-
related provisions. Looking at the text of the various subsections of section 401, each
subsection that refers to the act of certifying either uses the phrases "effluent limitation,"
"quality of waters," or "water quality requirements," or explicitly enumerates subsections
of the CWA having to do with water quality—section 301 (effluent limitations), section 302
(water quality-related effluent limitations), section 303 (water quality standards and
implementation plans), 306 (national standards of performance), and 307 (toxic and
pretreatment effluent standards). See 33 U.S.C. 1341(a), (d).

As discussed in the Agency's Response to Comments in Section 5.2, EPA strongly disagrees
that this final rule would permit certifying authorities to consider non-water quality-related
factors as the basis for a certification denial or condition. The scope of certification is
limited to adverse water quality-related impacts from the activity. That said, water quality-
related impacts can encompass impacts that adversely affect the chemical, physical, and
biological integrity of waters, which could include, for example, changes in water flow that
might affect aquatic habitat. See Section IV.E.2 and IV.E.3 for further discussion on the
water quality-related scope of section 401 review.

In response to commenters recommending that the Agency require certifying authorities to
demonstrate the likelihood of water quality-related impacts, the Agency finds it
unnecessary to establish the required degree of causality between the activity and the
impact to water quality. Consistent with the statutory text and purpose of section 401, final
rule section 121.3 clearly limits a certifying authority's analysis of any given activity to the
water quality-related impacts that may prevent compliance with water quality
requirements. It is incumbent on the certifying authority to develop a record to support its
determination that an activity will or will not comply with applicable water quality
requirements. If a project proponent believes a certification decision is based on
unreasonable conclusions regarding the water quality-related impacts of the activity, it may
likewise challenge that decision in court. This outcome is consistent with Congressional
intent. The legislative history reveals that Congress intended project proponents to seek
relief in state courts in instances where it disagreed with a certification decision. See, e.g.,
116 Cong. Rec. 8805, 8988 (1970) (Conf. Rep.) ("If a State refuses to give a certification, the
courts of that State are the forum in which the applicant must challenge that refusal if the
applicant wishes to do so."); H.R. Rep. No. 92-911, at 122 (1972) (same).

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The Agency also disagrees with commenters asserting that the term "water quality-related"
will cause implementation uncertainty or delays or be more expensive. Consistent with the
Agency's longstanding position, while EPA continues to interpret section 401 as providing
broad authority to certifying authorities to review activities subject to a Federal license or
permit, the review must be limited to the water quality-related impacts from the activity.
See Section IV.E.2.C for further discussion on Congressional intent, judicial interpretation,
and EPA interpretation on the water quality limitations in section 401. Accordingly, this
concept should be familiar to stakeholders. Nevertheless, the Agency has made several
clarifications in this final rule to clearly limit a certifying authority's analysis of any given
activity to adverse water quality-related impacts that may prevent compliance with water
quality requirements. See Section IV.E.2.b of the final rule preamble. These clarifications
should aid in implementation of the final rule. In response to the commenter assertions
regarding Federal agency enforcement, see Section IV. J of the final rule preamble.

5.3.2.3 Defining "Any Other Appropriate Requirement of State Law"

A few commenters disagreed with the Agency's interpretation of water quality requirements and "any
other appropriate requirement of state law," focusing on the Agency's proposed interpretation of section
401(a)(1) and (d). One commenter argued that although "water quality requirements" is not defined in the
CWA, the enumerated provisions in section 401(a)(1) delineate the scope of certification and section
401(d) does not change the scope. The commenter further asserted that the Agency must interpret the
term "any other appropriate requirement" by looking to the statutory provisions expressly identified in
section 401 and exhaust statutory construction tools before finding the statutory text ambiguous. Another
commenter asserted that the Agency should respect the principle of ejusdem generis when interpreting
what "any other appropriate requirements of state law" means. One commenter argued that the scope of
certification extends only to discharges because the CWA sections listed in subsection 401(d) regulate
only discharges. Another commenter argued that section 401(d) compels a limited focus on point source
discharges and asserted that it was unreasonable for the Agency to support its argument to expand beyond
point source discharges by stating that section 401(d) does not use the term; the commenter argued that
the Agency failed to analyze section 401(d) in connection with all of section 401 and the overall structure
and language of the CWA. The commenter also contested the Agency's argument that Congress failed to
expressly create a limited scope of review, arguing that the CWA is clearly focused on discharges,
navigable waters, and point sources, and that there is no express language on nonpoint sources in section

401.	One commenter argued that the term "any other appropriate requirement of state law" should be
interpreted consistent with the nosctiur a sociis interpretive canon, and because it follows an enumeration
of four specific sections of the CWA that are all focused on the protection of water quality from point
source discharges to waters of the United States, must be interpreted to include only those EPA-approved
provisions of state or Tribal law that implement the section 402 and 404 permit programs or otherwise
control point source discharges to WOTUS (citing Keffeler, 537 U.S. 371, 383-85 (2003); PUD No. 1,
511 U.S. at 728 (Thomas, J., dissenting)). Similarly, another commenter asserted that CWA sections 401,

402,	and 404 make it clear that only point sources are regulated and that courts have upheld that position.
The same commenter asserted that Federal agencies would be unable to implement or enforce
certification conditions pertaining to nonpoint sources. Another commenter argued that the text, structure,
and history of Section 401 requires the Agency to interpret Section 401(d) and the phrase "any other

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appropriate requirement" to include only those EPA-approved provisions of state or Tribal law that
implement the Section 402 and 404 permit programs or otherwise control point source discharges to
WOTUS. The commenter further asserted that this was consistent with the 1977 CWA amendments that
added CWA section 303 to the list of enumerated provisions because it is the provision through which
EPA approves state standards and does not regulate nonpoint sources of pollution, citing Or. Natural
Desert Ass'n v. Dombeck, 172 F.3d 1092, 1093-94 (9th Cir. 1998).

Several commenters expressed concern over the proposed rule's application of the term "appropriate."
One commenter argued that EPA failed to grapple with abuses surrounding application of the term
"appropriate." Another commenter argued that the statutory context makes clear that "appropriate" refers
only those state and Tribal requirements applicable to the discharges, and not every requirement that a
state or Tribe might deem appropriately related to water quality. The same commenter argued that it is
inconceivable that Congress intended to substantially repeal FERC's exclusive regulatory authority under
the Federal Power Act through the phrase "any other appropriate requirement of State law."

Several commenters provided suggestions on how the Agency should interpret "any other appropriate
requirement of state law." One commenter suggested limiting state or Tribal laws to "any other surface
water quality-related requirements of state or Tribal law." Another commenter asserted that PUD No. 1
said a state could only consider effluent limitations and water quality standards. A few commenters
suggested removing the word "any." One commenter suggested removing the term "any other water
quality-related requirement of state and Tribal law" and instead limit water quality requirements to the
enumerated provisions and any Federal or state and Tribal laws or regulations implementing those
sections. One commenter suggested that EPA limit appropriate state and Tribal laws to those
implementing protection of water quality requirements as provided for in sections 301, 302, 303, 306 or
307 of the CWA.

Agency's Response: In response to comments regarding the Agency's definition of water
quality requirements, including interpretation of "any other appropriate requirement of
state law," EPA finds that its definition of "water quality requirements" is the best
interpretation considering the text of section 401 and appropriately allows certifying
authorities to certify compliance with the enumerated provisions of the CWA and state and
Tribal water quality-related provisions (for both point and nonpoint sources). EPA's final
definition is also supported by the purpose, and legislative history of the statute. See Section
IV.E.2.C of the final rule preamble for further discussion on the Agency's analysis of the
statutory text, legislative history, Congressional intent, and prior judicial interpretation.

5.3.3 Suggestions of what Water Quality Requirements Should Include

One commenter asserted that many activities or conditions to protect designated uses do not impact water
quality, such as constructing recreational facilities. Similarly, another commenter argued that the Act does
not extend itself to designated uses of state water and asserted that designated uses are secondary to the
water quality associated with those uses. However, another commenter argued that some members of the
regulated industry who contest conditions related to recreational facilities and addressing pollutants from
upstream sources misunderstand the nature of state water quality requirements and asserted that many

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states regulate water quality by ensuring that water remain suitable for certain designated uses, which may
include uses such as recreation or fishing.

Several commenters asserted that the scope of certification should be limited to whether the discharge
complies with water quality standards. A few commenters asserted that the proposed scope was
unreasonable and would allow regulatory overreach because it allows certifying authorities to include
conditions beyond the discharge and its compliance with water quality standards. Another commenter
argued that section 401 conditions should be limited to those that directly impact attainment of water
quality standards. One commenter asserted that certifying authority review should be focused on
reviewing the water quality impacts of the federally-authorized discharge and that certifying authorities
may place conditions necessary for the discharge to achieve compliance with water quality standards.
Another commenter asserted that the purpose of Section 401 is to give states or Tribes the power to
ensure proposed Federal actions will not result in violations of water quality standards promulgated
pursuant to the CWA and argued that the proposal attempts to rely on the language of Section 401(d) to
trump the overall purpose and goal of section 401, which is to ensure discharges to waters of the United
States will comply with CWA water quality provisions.

Agency's Response: The Agency declines to explicitly identify which conditions would be
within or outside the scope of section 401 certification because, subject to a case-by-case
review of the particular facts presented by each certification, a wide variety of conditions
could be appropriate as necessary to prevent adverse impacts to a state's or Tribe's water
quality. However, to be clear, a certifying authority could condition an activity to ensure its
compliance with any and all components of applicable water quality standards (water
quality criteria, designated uses, and antidegradation requirements). See Section IV.E.3 of
the final rule preamble.

In response to the commenter suggesting that water quality requirements should be limited
to compliance with water quality standards, the Agency disagrees. Rather, consistent with
the statutory text, this final rule requires certifying authorities to consider whether the
activity will comply with water quality requirements, which includes but is not limited to
water quality standards. See Section III for further discussion on the textual changes from
Section 21(b) to Section 401, and Section IV.E for further discussion on the term "water
quality requirements."

5.4 Scope of Section 401(a) and (d)

One commenter argued that EPA erroneously asserted that a certifying authority may deny an application
under section 401(a) using the language from section 401(d) and that the scope of the certifying
authority's review with respect to granting or denying an application is limited to the applicant's
discharge. Conversely, another commenter agreed with EPA that interpreting sections 401(a)(1) and (d) to
impose two different scopes of review would be irrational.

Agency's Response: See Section IV.E.2.e of the final rule preamble.

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5.5 Disagree with Scope of Waters

Some commenters expressed concern that the proposed approach for scope would allow certifying
authorities to use the certification process and conditions for waters that are not "waters of the United
States." Several commenters disagreed with the Agency's proposed position that section 401 certification
decisions could consider impacts to non-"navigable waters" once the threshold discharge into a water of
the United States is met, arguing that it represented Federal overreach because it was out of the scope of
the Agency's authority and inconsistent with the scope of the Act. One commenter argued that no
provision of the CWA applies to waters other than waters of the United States and that it would be
unreasonable to assume that only section 401 would apply to other waters. Another commenter argued
that suggesting that section 401 has a broader scope than sections 402 and 404, even though they are in
the same permitting section of the Act, is in conflict with a reasonable interpretation of Congress' purpose
and statutory interpretation. One commenter argued that section 401(d), when analyzed with the rest of
section 401 and the general structure of the Act, makes it clear that certification is focused on sections
limited to discharges into navigable waters and it is irrelevant that section 401(d) does not use the term
"navigable waters." Similarly, another commenter asserted that ejusdem generis requires that any
requirements of state law be like the preceding requirements in the list, which precludes certifications
from taking non-navigable waters into account. A few commenters also asserted that this interpretation
would interfere with a state's authority to regulate surface water quality in non-navigable waters and
noted that states could regulate state waters under their own laws. One of these commenters noted that
this interpretation would present legal challenges for the Federal agency when it comes to enforcement of
certification conditions in non-navigable waters.

One commenter said EPA is arguing that because section 401 does not expressly prohibit Federal
regulation of state waters, Congress authorizes it. The commenter further said that this justification from
EPA for expanding the scope of review was rejected in the Supreme Court's decision in Solid Waste
Agency of Northern Cookv. United States, 531 U.S. 159 (2001) ("SWANCC").

One commenter said that "impacts to water quality," "activity as a whole," and "water quality
requirements" need to be applied in a manner consistent with the plain language and context of section
401, specifically focusing on the activity's "discharge into the navigable waters."

One commenter asserted that the proposal was the first time in Agency history that states could consider
impacts to non-navigable waters and from nonpoint sources of pollution.

Agency's Response: The Agency concludes that while a certifying authority is limited to
considering impacts to "waters of the United States" when certifying compliance with the
enumerated provisions of the CWA, a certifying authority is not so limited when certifying
compliance with requirements of state or Tribal law that otherwise apply to waters of the
state or Tribe beyond waters of the United States. As discussed in Section IV.E.2.d of the
final rule preamble, this interpretation best reflects the text of section 401. EPA recognizes
that some states regulate waters beyond CWA "navigable waters," while other states do not.
EPA's interpretation best supports principles of cooperative federalism by allowing those
states that do have laws applicable beyond "navigable waters" to apply those laws to those

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state waters in the certification context, and by not requiring other states to do so. See
Section IV.E.2.d of the final rule preamble for further discussion on the Agency's rationale.
EPA disagrees with the commenter that asserted that EPA adopted this interpretation
simply because EPA assumed that Congress authorized it "because section 401 does not
expressly prohibit Federal regulation of state waters." As explained in Section IV.E.2.d of
the final rule preamble, EPA affirmatively determined that its interpretation best reflects
what Congress intended by "any other appropriate requirement of State law."

For further discussion on why application of the maxim ejusdem generis ("of the same
kind") to limit "appropriate requirement of State law" to only those state law provisions
that impose discharge-related or point source-related restrictions is misplaced, see Section
IV.E.2.C of the final rule preamble.

The Agency disagrees with the commenter asserting that the proposal was the first time the
Agency stated that states could consider impacts to non-navigable waters or impacts from
nonpoint sources of pollution. This final rule realigns with the Agency's position prior to the
2020 Rule. See e.g., 2010 Handbook at 5 ("Note, however, that once §401 has been triggered
due to a potential discharge into a water of the U.S., additional waters may become a
consideration in the certification decision if it is an aquatic resource addressed by "other
appropriate provisions of state[] law."), 17 ("Thus, it is important for the [section] 401
certification authority to consider all potential water quality impacts of the project, both
direct and indirect, over the life of the project") (rescinded in 2019).

5.6 Explicit Input on Preamble Example Conditions

Some commenters provided input on the example conditions listed in the preamble that may be within the
scope of certification. A few commenters explicitly supported the listed examples, including one
commenter who noted each example has obvious water quality benefits and asked the Agency to codify
those examples as non-exhaustive conditions. One commenter suggested that the Agency should expand
the examples to include impacts from nonpoint sources and aquatic resource impacts resulting from
climate change or required adaptation to climate change, noting that nonpoint sources are one of the
principal sources of water quality impairments in assessed waters. A few commenters discussed the types
of conditions included on certifications for hydropower licenses, including minimum and/or maximum
instream flows, fish passage, erosion control measures, or development of a recreational facility to protect
designated uses related to recreation and/or the public's right to access rivers.

Several commenters disagreed that the example conditions listed in the preamble were appropriately
within the scope of certification. A few commenters argued that the scope of certification should be
limited to protection of water quality sufficient to support designated uses, as opposed to direct protection
of those uses. One of these commenters asserted that the CWA's goals and regulatory requirements do not
protect aquatic life and recreation directly, but rather the CWA is focused on restoring and maintaining
water quality to provide for those uses. Another commenter argued that the examples were unrelated to
effluent limitations or water quality standards and conflated water quality criteria for a designated use
with the activity promoted through designation and were outside the scope of the CWA. A few

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commenters focused specifically on the examples regarding public fishing access and recreation facilities,
arguing that they are not linked to preserving the water quality necessary for the designated use and
should not be in the scope of the rule. A few other commenters asserted that EPA was equating ensuring
people can enjoy the benefits of water quality with actually ensuring water quality and argued that
certifications should not include impacts that are not directly related to improving or maintaining water
quality. Another commenter argued that if EPA's interpretation of "designated uses" in the proposed rule
was correct, then EPA would require states to list waters with a recreational fishing designated use where
the landowner has not provided public access for fishing as "impaired." The same commenter further
asserted that if the regulation encompasses land use planning and non-water quality matters, then it would
trigger the major questions doctrine. Another commenter argued that the scope should be limited to
requirements related to the biological, chemical, and physical integrity of waters, and that the examples
such as construction of parking spaces, would not achieve that nor relate to water quality. Another
commenter expressed concern regarding the example conditions and asserted that such conditions could
negatively affect operation of critical flood control and water supply infrastructure.

One commenter expressed concern regarding the examples of out of scope conditions, noting that it might
leave ambiguous whether certifying authorities might consider that fossil fuels transported via proposed
pipeline will exacerbate climate related harms to state or Tribal waters.

Agency's Response: The Agency declines to explicitly identify which conditions would be
within or outside the scope of section 401 certification because, subject to a case-by-case
review of the particular facts presented by each certification, a wide variety of conditions
could be appropriate as necessary to prevent adverse impacts to a state's or Tribe's water
quality. The appropriateness of any given condition will depend on an analysis of all
relevant facts, including the certifying authority's applicable water quality requirements.
For potentially qualifying conditions, it is appropriate for the certifying authority to
consider all potential adverse water quality impacts. See Section IV.E.3 of the final rule
preamble.

5.7 Input Received on Prior Rulemakings

5.7.1 Input on the 2019 Proposed Rule

This sub-topic summarizes comments that were made on a previous proposed rulemaking and were
resubmitted by commenters in the docket for the 2022 proposed rule.

5.7.1.1 Do not support 2019 Proposed Rule

Some commenters did not support the 2019 proposed rule's approach to the scope of certification for
several reasons. One commenter asserted that the 2019 proposed rule ignored the text, purpose, and
legislative history of section 401, as well as binding Supreme Court precedent, and failed to provide
"good reasons" to reverse prior position. F.C.C. v. Fox Television Stations, Inc., 556 U.S. 502, 515
(2009). Similarly, another commenter asserted that the 2019 proposed rule conflicted with the CWA's
language, intent, or case law in four ways, including by limiting certification to ensuring that point-source

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discharges to navigable waters comply with EPA-approved water quality standards, by authorizing
Federal agencies to disregard certification conditions or denials, by narrowing the scope and timing of a
state's certification review, and by interfering with states' ability to follow their own administrative
procedures.

Another commenter questioned the legality of the 2019 proposed rule's approach to scope and asserted
that it would make it impossible to effectively protect water quality, while another commenter asserted
that narrowing the scope would have profound effects because it would ultimately prevent states from
ensuring that activities will not impair water quality in accordance with section 401.

One commenter said the 2019 proposed rule's scope of certification would unlawfully limit the extent of
activities covered by section 401 and the type of conditions imposed, while another commenter stated that
limiting the state's role in protecting water resources within their boundaries would damage the CWA's
cooperative federalism relationship.

Several commenters asserted that the 2019 proposed rule's limitation to only point source discharges was
inconsistent with the CWA. One of these commenters asserted that the Agency cherry-picked language
from the CWA to argue that the 1972 amendments were focused solely on regulating discharges, noting
that section 303, which is referenced in 401, empowered states to create and enforce water quality
standards unrelated to point source discharges. Another commenter argued that the scope cannot be
limited to just the discharge because Section 401(a) does not even require an actual discharge; rather the
statute triggers certification when a discharge "may result."

Several commenters stated that it has been established that section 401 allows states to consider the water
quality impacts of the activity as a whole, citing PUD No. 1 and S.D. Warren, and one of these
commenters further asserted that if certification is limited to discharges, then the PUD No. 1 decision
would be illogical. Several commenters also asserted that the Court in PUD No. 1 based its interpretation
on the plain language of section 401. One of these commenters disagreed that the PUD No. 1 was based on
EPA's previous interpretation rather than the plain language. Another one of these commenters asserted
that EPA's reliance on BrandXto contradict PUD No. 1 was misplaced for several reasons, including
arguing that the Court relied on the plain language of section 401 in PUD No. 1, that it was unsettled
whether Brand X applied to prior Supreme Court decisions citing United States v. Home Concrete &
Supply, LLC, 566 U.S. 478, 488-89 (2012).

One commenter noted that there were clear differences in the language of section 401(a) and (d) that were
deliberate and must be given full import, while another commenter asserted that the 2019 proposed rule's
interpretation of section 401(d) rendered the term "applicant" meaningless and would preclude certifying
authorities from imposing conditions related to impacts not direct related to point source discharges.
Similarly, another commenter argued that EPA ignored the plain language in section 401(d), which
describes the scope of conditions that states impose on an "applicant." The same commenter asserted that
the 2019 proposed rule's argument that the terms "discharge" and "applicant" meant the same thing
violates a fundamental principle of statutory interpretation that "the words Congress use[s] ... are not
surplusage; they have some meaning and were intended to accomplish some purpose of their own." Fed.
Power Comm 'n v. Tuscarora Indian Nation, 362 U.S. 99, 130 (1960).

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Commenters provided specific input on the 2019 proposed rule's interpretation of the term "any other
appropriate requirement of state law." Some commenters asserted that the 2019 proposed rule's
interpretation of "any other appropriate requirement of state law" was contrary to the clear language of
section 401. One of these commenters asserted that such an interpretation would radically curtail current
practice and limit states' ability to protect their waters. Another of these commenters asserted that the
2019 proposed rule approach to "any other appropriate requirement of State law" would be inconsistent
with the CWA goals and leads to potential expense for applicants because states would be more likely to
deny certification. The commenter also asserted that it would limit conditions necessary protect wetlands
and other special aquatic sites, such as conditions addressing sediment and erosion.

One commenter asserted that the 2019 proposed rule's interpretation of "any other appropriate
requirement of State law" was irrational, contradicted the statutory text, and was inconsistent with the
legislative history. The commenter also asserted that because EPA-approved standards were included in
the provisions listed in section 401(a) and (d), it would render the term an extraneous duplication or a
nullity. Another commenter argued that limiting "any other appropriate requirement of state law" to EPA-
approved CWA programs would significantly limit the broad statutory language without adequate
justification.

One commenter argued that the CWA makes it clear that the scope of state authority to ensure compliance
with "any other appropriate requirement of State law" is expansive, citing CWA section 510 and PUD No.
1, while another commenter noted that section 401 and 510 demonstrate Congress' clear intent to
supplement and amplify state authority and the proposed approach clashed with Congress' explicit and
long-standing desire for the CWA not to preempt state law.

Several commenters discussed EPA's characterization of the legislative history. One commenter asserted
that EPA ignored Congress's characterization of changes in the 1972 amendments as "minor." Another
commenter asserted that section 21(b) was nearly identical to section 401 and embodied Congress'
consistent intent that states exercise broad authority over all water quality impacts that could result from
federally licensed or permitted activities.

Several commenters discussed their concerns with the 2019 proposed rule's impacts on state and Tribal
ability to protect their water quality. One commenter asserted that states would be powerless to protect the
beneficial uses of their waters. Commenters also expressed concerns about litigation, regulatory
uncertainty, and increased denials.

Agency's Response: See the Agency's Response to Comments in Sections 5.1-5.6; see also
Section IV.E of the final rule preamble.

5.7.1.2 Support 2019 Proposed Rule

Some commenters supported the 2019 proposed rule's scope of certification, arguing that it was
consistent with the statutory text and Congressional intent and balanced the cooperative federalism
principles of the CWA.

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One commenter asserted that the 2019 proposed rule's interpretation of scope appropriately addressed the
statutory ambiguity between the term "discharge" in section 401(a)(1) and "applicant" in section 401(d),
which have been interpreted as allowing conditions that address water quality impacts from any aspect of
the proposed activity as a whole. A few commenters asserted that the ambiguity has led to inconsistent
interpretations of the scope of the certifying authority's review by certifying authorities and courts.
Similarly, another commenter asserted that perverse interpretations of "applicant" and "activity" enabled
the expansion of the scope of Section 401 certification far beyond water quality concerns and stated that
the 2019 proposed rule has appropriately fixed the interpretation of these terms to their plain language
roots.

One commenter asserted that 2019 proposed rule's interpretation of scope reflected a reasoned analysis
that recognized that the 1971 Rule was promulgated prior to the 1972 CWA amendments and that the
section 401 process had been undermined by costly and conflicting interpretations. Another commenter
also agreed with EPA's proposed scope of certification would provide appropriate bounds consistent with
a logical reading of section 401 and that section 401's purpose and placement within the CWA clearly
limited the scope to discharges affecting water quality. Similarly, another commenter asserted that
limiting the scope to point source discharges was well-supported by the recognition that section 401 was
first in the section directly related to Federal permits and licenses and that Federal authorities under the
CWA focus on controlling point source discharges.

Several commenters acknowledged that the 2019 proposed rule's interpretation of scope differed from the
majority opinion in PUD No. 1, but noted that the Agency correctly noted that the opinion did not deprive
the Agency of its authority to interpret ambiguous statues reasonably, citing BrandX.

Several commenters agreed that the scope of section 401 should be limited to water quality
considerations, including one commenter who argued that section 401 and the CWA generally focused on
water quality and there was no suggestion that non-water quality considerations or conditions were
appropriate under section 401. A few of these commenters argued that that statutory language,
specifically in section 401(d), had been read to expand the scope beyond water quality outside the
reasonable bounds of the CWA.

One commenter agreed that the scope of a grant or denial is the same as the scope of a certification with
conditions and asserted that the 2019 proposed rule's scope reflected both sections 401(a)(1) and (d).

Several commenters specifically discussed the term "water quality requirements" or components of it.
One commenter agreed with the 2019 proposed rule's definition of "water quality requirements" because
it was based on a holistic reading of the Act and included a logical reading of the term "appropriate
requirement of state law" that would decrease opportunities for abuse. The commenter also argued that
the 2019 proposed rule's approach to "appropriate requirement" was consistent with the structure and
purpose of the Act and Justice Thomas' opinion in PUD No. 1, which the commenter asserted was the
more logical and internally consistent reading of section 401 and the CWA. Another commenter asserted
that the term "requirements of state law" should be interpreted as a state water quality law that provides a
standard or requirement and not a prohibition on an action.

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Several commenters discussed their experience with section 401 prior to the 2019 proposed rule and
asserted that states had abused the section 401 process, specifically for infrastructure projects. One
commenter asserted that there was an increase in states misusing 401 over the past several years to block
important pipeline projects that would replace less-efficient and higher emission fuel sources. Another
commenter asserted that some states had used section 401 to block infrastructure projects in the public
interest, citing two 2017 certification denials in New York (Northern Access) and Washington
(Millennium Bulk Terminal). The commenter argued that states should not be allowed to unilaterally and
negatively impacts the economies of other states and the nation under the guise of implementing Federal
law. The commenter also argued that some states had denied certification based on downstream effects on
climate by increased fossil fuel usage or opposition to expansion of fossil fuels general, citing the State of
New York's denial of the Valley Lateral Project. The commenter asserted that this practice increased
regulatory burdens and frustrated economic and national security, in addition to thwarting the express will
of Congress. Another commenter argued that it had seen states utilize section 401 to address direct and
indirect effects associated with projects (e.g., global warming) that are completely unrelated to CWA
permitting authorities.

One commenter recommended that EPA should clarify that certifying authorities should not seek absolute
certainty when determining whether a discharge will comply with applicable water quality standards, but
rather whether there is a reasonable basis for compliance. The same commenter also recommended that
the Agency should clarify that where a discharge does not directly discharge to a navigable water, any
secondary impacts cannot trigger Section 401.

Agency's Response: See the Agency's Response to Comments in Sections 5.1-5.6.

5.7.2 Pre-proposal Input from 2021

This sub-topic summarizes input that was received prior to the 2022 proposed rule and was resubmitted
by commenters in the docket for the 2022 proposed rule.

5.7.2.1 Do not support 2020 Rule

One stakeholder asserted that the 2020 Rule's interpretation of the scope as limited to point source
discharges was unsupported by the CWA, legislative history, EPA's prior regulations, and EPA's prior
guidance, and was rejected by the Supreme Court in PUD No. 1. Additionally, the stakeholder asserted
that EPA does not have the authority to limit the scope in such a manner. Another stakeholder asserted
that the 2020 Rule's scope was the most environmentally harmful and legally indefensible provisions of
the rule, and ran counter to the CWA, congressional intent, case law, and EPA's longstanding prior
interpretations. The stakeholder also asserted that EPA based its interpretation on minor statutory
language modifications between section 21(b) and section 401 and rejected EPA's suggestion in the 2020
Rule that a "holistic" review of section 401 or a minor amendment to the text of the statute justify limiting
the scope of state review to point source discharges into waters of the United States. Similarly another
stakeholder asserted that EPA's interpretation of the word "discharge" and the scope contradicted the
plain language of the Act and ignored case law and EPA's longstanding position recognized the scope as

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the activity. According to the stakeholder, section 401 does not require a discharge to occur, so restricting
certification to focus on the discharges of pollutants is nonsensical. Another stakeholder asserted that
EPA could not justify limiting the types of discharges that fall within section 401 based on Federal
enforcement authority because such limitation has no basis in the CWA.

One stakeholder asserted that the term "other appropriate requirements] of State law" is intended to be
broader than just specific sections of the Act and point source discharge regulatory requirements as
enumerated in the 2020 Rule and argued that limiting states and Tribes to EPA-approved water quality
standards would be contrary to statute. Another stakeholder argued that EPA should not define "any other
appropriate requirement of state law" or "water quality requirements" because state and Tribal courts and
administrative hearing boards have issued and reviewed certifications for decades without the delays
industry complained of prior to the 2020 Rule.

Several stakeholders asserted that the legislative history did not support the 2020 Rule's scope of
certification, arguing that the changes from the 1970 Act to the 1972 Act supported the "activity as a
whole" scope and that the legislative history did not suggest Congress intended the scope to be so narrow.
Several stakeholders also asserted that the 2020 Rule's scope was at odds with the Supreme Court's
decision in PUD No. 1 of Jefferson Cty. v. Wash. Dep't of Ecology, 511 U.S. 700, 711-14 (1994).

One stakeholder argued that EPA must consider water quality impacts and ensure that the new rule is
consistent with the CWA's purpose, asserting that the 2020 Rule failed to consider the water quality
harms that would result from the rule and instead focused on speculative, unrepresentative examples from
industry. The stakeholder additionally stated that the restoration and maintenance of the nation's water
quality is the only objective of the CWA and the most important aspect of the problem to be considered.
The stakeholder argued that the Agency cannot ignore express statutory objectives and factors and that if
EPA "fail[s] to grapple with" how the rule affects EPA's "statutory scientific mandate[]" to safeguard the
chemical, physical, and biological integrity of the Nation's waters, EPA will "fail[] to consider an
important aspect of the problem," rendering the rule arbitrary and capricious under the Administrative
Procedure Act. Physicians for Soc. Responsibility v. Wheeler, 956 F.3d 634, 647 (D.C. Cir. 2020).
Another stakeholder argued that EPA did not do any analysis of the harm to rivers, streams, wetlands, and
other waters that have historically received these protections under the 401 program.

Some stakeholders also discussed challenges associated with implementation of the 2020 Rule and/or its
impact on water quality. One stakeholder asserted that it had experienced challenges in implementing the
2020 Rule due to questions about the scope of certification and ability to impose conditions. Similarly,
another stakeholder asserted that it had to limit conditions relating to administrative conditions, invasive
species conditions, and threatened and endangered species conditions in light of the 2020 Rule, which the
stakeholder argued has ultimately diminished its authority to meet the goals of the CWA. Another
stakeholder argued that under the 2020 Rule, certifying authorities and the public have significantly less
opportunity to protect their waters from the harms of projects requiring Federal permits and discussed five
examples of ongoing consequences from the 2020 Rule. A few stakeholders discussed the sort of impacts
an activity may have on water quality and asserted that an activity as a whole scope allows certifying
authorities to add conditions on a project that are crucial to preserving water quality, e.g., addressing
erosion, sedimentation, temperature, flow requirements. One stakeholder argued that the 2020 Rule

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hamstringed state authority and undermined or even eliminated decades old state environmental
protections to address water quality impacts from Federal projects, specifically discussing harms related
to hydropower licensing and relicensing (e.g., dams cause increased water temperature resulting from
decreased water flows within streams and decreased flow rates as a result of ponding behind dam
structures) as well as destruction of aquatic habitat and increase pollution transport due to nutrient loading
and excess sedimentation.

One stakeholder argued that EPA based the 2020 Rule on the false narrative that certifying authorities
were misusing Section 401.

Agency's Response: See the Agency's Response to Comments in Sections 5.1-5.6.

5.7.2.2 Support 2020 Rule

Some stakeholders expressed support for the 2020 Rule's interpretation of the scope of certification. One
stakeholder argued that the 2020 Rule provided a detailed discussion of the statutory, regulatory, and
legal history of section 401 and established a clear framework to justify EPA's clarifications to the
regulations governing the scope of section 401 certifications. Another stakeholder asserted that the 2020
Rule recognized the interrelation of sections 401(a)(1) and (d) that, when read in isolation, exhibit a facial
incongruity that had created significant challenges in implementing Section 401 uniformly and fairly
across the nation. The stakeholder asserted that the 2020 Rule's interpretation was clear and supported by
statute, and argued that the Court's interpretation of section 401(d) did not bind EPA, citing BrandX. The
stakeholder also asserted that there is no evidence that Congress intended to convey broader conditioning
authority under Section 401(d) than necessary to support the focus of the state's review stated in Section
401(a). Similarly, another stakeholder argued that the 2020 Rule's definition of "water quality
requirements" clarified the scope by harmonizing sections 401(a) and (d) and asserted that Congress'
listing of those provisions of the CWA in section 401 makes clear that the authority granted to certifying
authorities was limited to point source discharges into navigable waters. Another stakeholder argued that
EPA's 1971 Rule was incongruent with the CWA and the 2020 Rule's interpretation of the CWA was
correct, consistent with ejusdem generis and noscitur a sociis canons, consistent with the presumption
that statutory amendments are intended to have real and substantial effect, and permissible under PUD
No. 1. The stakeholder also asserted that any interpretation that allows certifying authorities to make
certification decisions based on matters unrelated to water quality would be an unreasonable
interpretation of the statute and create boundless discretion and inject ambiguity. One stakeholder argued
that the 2020 Rule's limitation to point source discharges was well-supported by the recognition that
section 401 is the first part of Title IV of the CWA and that Federal authorities under the CWA focus on
controlling point source discharges.

One stakeholder recommended that EPA should limit section 401 certification to water quality impacts
that directly result from actions taken by the applicant within the scope of the Federal permit or license,
specifically discussing hydroelectric power generating facilities which effectively act as a passthrough for
pollutants added by upstream sources that are beyond the control of the project proponent and the Federal
licensing or permitting authority.

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Several stakeholders discussed their experience prior to the 2020 Rule to assert that the 2020 Rule should
remain in place. One stakeholder argued that it saw a wide range of interpretations of the scope of
certification prior to the 2020 Rule, which undermined predictable understanding regarding section 401
certification requirements and contributed to very long and costly process for federally permitting mining
projects. The stakeholder asserted that some states had used section 401 certifications to try and address
direct and indirect effects associated with projects unrelated to CWA permitting. The stakeholder also
argued that it had not seen any impact on state or Tribal authority to protect water quality due to the 2020
Rule. Another stakeholder stated that prior to the 2020 Rule, there were situations where states sought to
expand section 401 authority to address nonpoint source discharges or projects without discharges, which
added unnecessary cost and time to critical infrastructure projects. One stakeholder argued that the State
of Washington's denial of certification for a proposed coal facility, the Millennium Bulk Terminal, was a
paradigmatic example of abuse and that Wyoming had been adversely impacted by the misapplication of
other states' CWA Section 401 certifications. Another stakeholder asserted that certifying authorities
have attempted to expand the scope of Section 401 beyond water quality based on an erroneous
interpretation of the phrase "any other appropriate requirement of state law" to include conditions related
to odorization of gas, mitigation measures to address past contamination, construction at the site, and
requirements to adjust herbaceous stratum at the site.

Agency's Response: See the Agency's Response to Comments in Sections 5.1-5.6; see also

Section IV.E of the final rule preamble.

6. Certification Decisions (Section 121.7)

6.1 What It Means "To Act"

Some commenters supported the proposed definition of actions that a certifying authority may take as
grant, grant with conditions, deny, or waive. A few of these commenters suggested that the proposed
definition is correct in not including taking "significant and meaningful action" as an action that a
certifying authority may take on a request for certification. A few of these commenters stated that the
proposed definition provides much needed clarity. A few of these commenters noted they supported
proposed section 121.7(a) which provides that a certifying authority may act on a certification request in
only the four ways specified, and that, in doing so, the certifying authority must act within the scope of
certification and within the reasonable period.

A few other commenters suggested that the proposed definition needs additional clarity to state that the
four actions proposed are the only ways in which a certifying authority may "act" on a request for
certification. One commenter further stated that the proposed definition does not provide a clear end
point. A few other commenters suggested that the final rule should remove the term "expressly" from the
waiver provisions because the CWA does not provide any circumstances in which certification can be
waived before the reasonable period of time expires, and EPA does not have the authority to add
provisions in which a certifying authority can expressly waive certification.

A few commenters stated that the term "to act" should be interpreted more broadly than the proposed
definition. A few commenters argued that the final rule should not prescribe the types of actions a

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certifying authority may take to avoid waiving certification, including one commenter that suggested the
Agency should delete proposed section 121.7(a). A few commenters stated that defining "act" as "decide"
violates the presumption that Congress could have included language that it did not. One commenter
stated that Congress deliberately used the language "fails or refuses to act" instead of "grant or deny"
when crafting the statutory text of section 401. A few commenters stated that a certifying authority acting
in "good faith" to make a final decision on a certification request should not be deemed a failure to act
even if that decision takes longer than one year. One commenter specifically stated that the final rule
should adopt the Fourth Circuit's interpretation of "to act" to mean something more than making a final
decision on a certification request. N.C. Dep 't of Envtl. Quality (NCDEQ) v. FERC, 3 F.4th 655 (4th Cir.
2021). This commenter further stated that absent sheer inactivity, a certifying authority's inability to make
a final decision within the reasonable period of time should not be deemed a "failure to act" resulting in a
waiver.

Agency's Response: Consistent with the CWA, EPA is finalizing the proposed approach
that a certifying authority must make one of four decisions on a request for certification
pursuant to its section 401 authority: it may grant certification, grant certification with
conditions, deny certification, or it may expressly waive certification. 40 CFR 121.7(a).

The Agency disagrees with commenter assertions that the text located at section 121.7(a)
needs further clarification. EPA finds that the regulatory text at final rule section 121.7(a)
clearly provides that the four decisions (grant, grant with conditions, denial, express
waiver) are the only ways in which a certifying authority may act. However, EPA wishes to
clarify that any attempt at a "hybrid" version of those four decisions does not meet the
standard of "acting" on a request for certification (e.g., a waiver with conditions, a
conditional denial). See Waterkeepers Chesapeake, et al. v. FERC, 56 F.4th 45, 49 (D.C. Cir.
2022) (holding that FERC could not issue a license "[i]f a state has neither granted a
certification nor failed or refused to act on a certification request" and finding that
"Maryland's subsequent backtracking in the settlement agreement, in which it
'conditionally waiv[ed]' its authority to issue a water quality certification after the fact, is
neither a 'fail[ure]' nor a 'refus[al]' to act" and therefore could not "qualify as a section
401(a)(1) waiver."). To further clarify how a certifying authority may act on a request for
certification, the Agency is finalizing regulatory text that encourages certifying authorities
to clearly identify whether a decision is a grant, grant with conditions, denial, or express
waiver. See Section IV.F for further discussion on the recommended contents of a
certification decision.

EPA disagrees that the term "expressly" should be removed from the waiver provision and
reaffirms that an "express waiver" is one of the four ways to act on a request for
certification. While the Agency recognizes that the statute does not explicitly state that a
certifying authority may expressly waive certification, EPA has determined that providing
this opportunity in this final rule is consistent with a certifying authority's ability to waive
through failure or refusal to act. See EDF v. Alexander, 501 F. Supp. 742, 771 (N.D. Miss.
1980) ("We do not interpret [the Act] to mean that affirmative waivers are not allowed.

Such a construction would be illogical and inconsistent with the purpose of this

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legislation."). Express waivers are consistent with the Agency's longstanding interpretation
of the waiver provision and may create efficiencies where the certifying authority knows
early in the process that it will waive. See 40 CFR 121.9(a)(1) (2020) (allowing a certifying
authority to expressly waive certification via written notification); 40 CFR 121.16(a) (2019)
(same).

The Agency disagrees with commenters requesting the Agency to expand, or alternatively
not define, what it means to act on a request for certification. The Agency finds that
defining "to act on a request for certification" as making one of the four certification
decisions described in the final rule is reasonable, consistent with Congressional intent, is
consistent with longstanding Agency position and case law, and allows for greater certainty
and transparency in the certification process. First, while Congress did not use the words
"grant or deny" or "decide" in place of "act on a request for certification," in context it
seems evident that these are the actions Congress had in mind. After all, section 401(a)(1) is
about the effects of granting or denying certification. Moreover, while Congress did not use
the words "grant or deny," it likewise did not use a term that clearly indicated that
Congress had in mind something short of a final "action" on a request for certification.
Congress clearly intended to balance state water quality concerns with the need to guard
against unreasonable delays in the Federal licensing or permitting process. See, e.g., 115
Cong. Rec. 9257, 9264 (April 16,1969) ("The failure by the State to act in one way or the
other within the prescribed time would constitute a waiver of the certification required as to
that State."); H.R. Rep. No. 91-940, at 54-55 (March 24,1970) (Conf. Rep.) ("In order to
insure that sheer inactivity by the State ... will not frustrate the Federal application, a
requirement, similar to that contained in the House bill is contained in the conference
substitute that if within a reasonable period, which cannot exceed one year, after it has
received a request to certify, the State ... fails or refuses to act on the request for
certification, then the certification requirement is waived.").

For similar reasons, the Agency declines commenter requests to interpret "to act on a
request for certification" as acting in a "significant and meaningful" way. If a certifying
authority could merely act in a "significant and meaningful" way to avoid waiver at the
expiration of the reasonable period of time, it could delay the Federal licensing or
permitting process well beyond the statutory one year timeframe and have the same
practical effect as denying certification without going on the record to do so. While
Congress provided states and Tribes with a powerful tool to prevent federally licensed or
permitted activities that will not comply with water quality requirements, Congress clearly
intended states and Tribes to take an affirmative action to prevent such activities. 33 U.S.C.
1341(a)(1) ("No license or permit shall be granted if certification has been denied ...")
(emphasis added). The Agency finds that defining "to act" as taking one of the four
decisions contemplated in section 401 best effectuates Congressional intent and respects the
cooperative federalism balance central to section 401. Further, at proposal, EPA shared
similar concerns as stakeholders with the NCDEQ approach, noting that it may make the
section 401 certification process less predictable and transparent. 87 FR 35350. The Agency
remains concerned that interpreting "to act on a request for certification" as any

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"significant and meaningful action" might inject significant uncertainty and subjectivity
into the certification process (e.g., what is a "significant and meaningful action?") causing
significant confusion for stakeholders. Id. EPA finds that the final rule approach will
provide stakeholders with a clear and predictable endpoint for knowing when the certifying
authority has failed or refused to act, resulting in a waiver. See 33 U.S.C. 1341(a)(1).

6.2 Contents of a Certification Decision

6.2.1 Do Not Support Inclusion of Citation and Explanation Requirement

Some commenters supported the proposed rule's removal of specific statutory or regulatory citations for
each certification condition. A few commenters expressed support for the proposed rule's removal of
specific statutory or regulatory citations for denials. Some other commenters asserted that the Agency
should remove all content requirements for a certification with conditions and for denials. Almost all of
those commenters noted that the explanation requirements place an undue burden on the certifying
authority.

A few commenters argued that including justifications for certification conditions interferes with the
readability of the certification as a whole. Another commenter suggested that instead of explanation
requirements for each condition, certifying authorities should be allowed to provide an explanation for a
group or category of conditions. A few other commenters said the Agency should consider guidance to
help certifying authorities develop certification decisions that are transparent.

Agency's Response: After considering public comments and in support of the cooperative
federalism balance central to section 401, the Agency is not mandating the contents that
certifying authorities must include in their certification decisions. Instead, the final rule
includes recommended contents for a grant of certification (section 121.7(c)), a grant of
certification with conditions (section 121.7(d)), a denial of certification (section 121.7(e)),
and an express waiver of certification (section 121.7(f)).

EPA expects certifying authorities understand the importance of clear, transparent
communication with project proponents and Federal agencies. Indeed, it is in the certifying
authority's own interests to clearly convey the reasoning and rationale behind its action. To
encourage development of clear certification decisions, the Agency is identifying
recommended—but not required—contents for each certification decision type at final rule
section 121.7(c)-(f). These contents are similar to the contents proposed (to be required) at
section 121.7(c)-(f), with modifications based on stakeholder input. See section IV.F of the
final rule preamble. The recommended contents should provide transparency and
consistency in the certification process, particularly where a certifying authority does not
have a standard approach for the contents of a certification decision. See Section IV.F of the
final rule preamble for further discussion on the benefits of including the recommended
information and possible ways a certifying authority may address readability concerns
identified by commenters.

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6.2.2 Support Inclusion of Citation and Explanation Requirement

Some commenters supported the proposed requirement for a statement explaining why each of the
included conditions is necessary to assure that the activity as a whole will comply with water quality
requirements. These commenters argued that the explanation requirement provides transparency and
regulatory certainty to the project proponent and the public in understanding the certifying authority's
rationale.

Some commenters expressed support for the 2020 Rule's requirement for citations on denials and
certification conditions. One commenter requested EPA to require certifying authorities to identify the
precise state requirements that exceed the Federal requirements for certification, noting that project
proponents are often unaware of whether a certification includes "other state requirements." A few of
these commenters also explicitly recommended that the final rule should retain the 2020 Rule's
requirement for explaining certification conditions and denials. A few of these commenters argued that
citations are necessary for legally defensible certification decisions.

Some commenters argued that denials due to insufficient information should, as in the 2020 Rule, include
an explanation of what information was missing. Another commenter suggested that without a basis for
denial, project proponents may have to challenge the denial.

A commenter recommended that certification decisions should require a sufficient level of supporting
materials to ensure the certification decision is within the scope of section 401 and asserted that the
proposal would give states unfettered authority to include any condition in a certification it deems
necessary. Another commenter asserted that case law supports that states exercising authority under
section 401 must act in a way that is reasonable and adequately explained.

Agency's Response: EPA appreciates commenter input on the contents of certification
decisions. As discussed in Section IV.F of the final rule preamble, the Agency is declining to
mandate the contents that certifying authorities must include in their certification decisions.
Instead, the final rule includes recommended contents for a certification decision. The
recommended contents should provide transparency and consistency in the certification
process, particularly where a certifying authority does not have a standard approach for
the contents of a certification decision. See the Agency's Response to Comments in Section
6.2.1; see also Section IV.F of the final rule preamble for further discussion on the
recommended contents of a certification decision.

Before the 2020 Rule, EPA did not impose requirements on certifying authorities regarding
what information they must include in a denial or what information they must include to
support a certification condition. EPA is not aware of any major issues regarding clarity or
information in certification denials or conditions. Instead of mandating detailed
requirements for certifying authorities, the final rule identifies recommended contents for a
grant of certification, a grant of certification with conditions, a denial of certification, and
an express waiver of certification. This approach addresses workload concerns expressed by
certifying authorities and, in support of the cooperative federalism balance central to

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section 401, provides certifying authorities with the flexibility to determine how best to
communicate certification decisions to project proponents and Federal agencies. It also will
eliminate unnecessary potential disputes about whether a certifying authority complied
with EPA-issued requirements for certification decision documents (in addition to whatever
requirements the certifying authority imposes on itself).

In response to commenter assertions regarding concerns that the proposal would give states
unfettered authority to include any condition in a certification, the Agency strongly
disagrees. As discussed in Section IV.E.2.e of the final rule, the scope of review for a
certification decision is the same as the scope of permissible conditions that may be added to
that certification and requires that a certifying authority include conditions necessary to
assure that the activity will comply with applicable water quality requirements. For further
discussion on the scope of certification, including limiting principles, see Section IV.E of the
final rule preamble and the Agency's Response to Comments in Section 5.

6.2.3 Other Comments Addressing the Proposed Contents of a Certification Decision

One commenter suggested replacing the term "shall" throughout proposed section 121.7 with either the
word "may" or "should."

One commenter supported the proposed contents of a waiver; specifically, the requirement for an express
waiver being in writing.

One commenter asserted that it may be better for a certifying authority to rely on other permits and
authorizations rather than include conditions in a certification decision. Accordingly, the commenter
requested that EPA affirmatively recognize in the final rule that certifying authorities may rely on other
permits and authorizations to support their certification decisions.

One commenter asserted that the final rule should differentiate the contents of a certification decision
between individual and programmatic permits (i.e., NWPs). Another commenter recommended that EPA
should revise the requirements for the contents of a grant of certification with or without conditions to
clearly state what a certifying authority must submit for a draft license or permit that has programmatic
application. The commenter asserted that there are no specific names or addresses known at the time a
draft general permit with programmatic application is issued (e.g., Corps NWPs).

A few commenters suggested that the final rule should remove any requirements to include the
identification of the Federal license or permit. One of these commenters suggested that certifying
authorities should not be required to identify the Federal license or permit, because the certification
request is associated with the proposed activity, irrespective of the specific Federal license or permit the
project proponent must acquire. The commenter asserted that if this requirement is retained, then it will
result in a significant number of post-certification modifications if there are substantial changes in an
application for authorization which result in a different authorization being issued. Another one of these
commenters recommended removing the requirement to identify the applicable Federal license or permit
to avoid complications where the certifying authority fails to identify all applicable Federal license or

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permit requirements and asserted that identification of the activity was sufficient. One commenter
recommended that the final rule should remove any requirements to include the identification of the
Federal license or permit number.

One commenter suggested that EPA should encourage certifying authorities not to create additional
requirements for certification on renewable energy projects and asserted that the proposed modification
process would be robust enough to address any concerns after certification is granted and avoid project
delays. The commenter suggested that EPA could also create a template MOA for these projects to allow
for predictable timing and conditions.

Agency's Response: As discussed in Section IV.F of the final rule preamble, the Agency is
not requiring certifying authorities to include the components listed at section 121.7(c)-(f) in
their certification decisions, but instead defining recommended contents of certification
decisions. Accordingly, the Agency has replaced the word "shall" with "should" in section
121.7(c)-(f), except the Agency is finalizing that certification decisions must be in writing.

The Agency appreciates commenter support for the proposed contents of an express waiver.
Although the Agency is not finalizing required components for an express waiver, the
Agency is finalizing a requirement that all certification decisions be in writing.

The Agency declines to provide a categorical list of materials or facts that a certifying
authority may rely on to support a certification decision. Information needs or justifications
for a particular certification decision will depend on the relevant facts for a specific project,
including but not limited to project specifics (e.g., project type, location, etc.) and the
certifying authority's water quality requirements. Certifying authorities are best suited to
determine their information needs to support a certification decision on a project-by-
project, or project type, basis.

In response to the commenter requesting that the Agency distinguish between the contents
in a certification decision for an individual permit versus general permit, the Agency is not
distinguishing between certification decisions based on an individual or a general Federal
license or permit. Although EPA made such a distinction in the 2020 Rule, EPA finds it
unnecessary in this final rule because it is no longer defining required certification decision
contents and the recommended contents would apply to a certification with conditions
regardless of the nature of the Federal license or permit.

The Agency is removing the inclusion of the name and address of the project proponent
from the list of recommended contents of each certification decision. The Agency finds this
component unnecessary since the certification will be included with the Federal license or
permit that will identify the appropriate project proponent. However, the Agency is
retaining the identification of the applicable Federal license or permit as one of the
recommended components for all certification decisions. While this final rule is only
recommending the identification of the Federal license or permit, the Agency observes that
there must be a Federal license or permit to trigger the section 401 process. As such, the

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Agency intends for this component to help clarify which Federal license or permit the
certification decision applies to.

The Agency declines to create any project specific certification decision requirements or
MOA templates, consistent with its decision to not finalize any required contents in
certification decisions. This approach provides certifying authorities with the flexibility to
determine how best to communicate certification decisions to project proponents and
Federal agencies. EPA anticipates that certifying authorities will work with project
proponents and Federal agencies to determine what information would be most useful. See
Section IV.F of the final rule preamble and the Agency's Response to Comments in Section
6.1.1, 6.1.2 for further discussion on why the Agency is not finalizing any required contents
for certification decisions. To the extent the commenter is suggesting that the Agency should
categorically bar certification conditions on a class of projects, or even suggest such, the
Agency declines to take such an approach. Certifying authorities are best positioned to
determine whether any conditions are necessary to assure that the activity subject to the
Federal license or permit will comply with applicable water quality requirements.
Additionally, whether or not conditions are necessary, and if so, the type(s) of conditions
necessary to assure the activity will comply with applicable water quality requirements is
subject to a case-by-case review of the particular facts presented by each certification.
Ultimately, a wide variety of conditions could be appropriate as necessary to prevent
adverse impacts to a state's or Tribe's water quality. The appropriateness of any given
condition will depend on an analysis of all relevant facts, including the certifying authority's
applicable water quality requirements. See Section IV.E of the final rule preamble for
further discussion on the scope of certification, including the scope of conditions.

6.3 General

6.3.1 Reasonable Assurance

A few commenters provided input on the use of the term "will comply" versus "reasonable assurance" in
certification decisions. One commenter requested that EPA should consider changing the explanatory
statement language back to that required in the 1971 Rule, stating, "there is reasonable assurance that the
activity will not violate applicable water quality standards." Another commenter expressed concern over
replacing the term "reasonable assurance" with "will comply" at proposed 40 CFR 121.7(c)(2) but
accepted the proposed preamble's position that there is no practicable difference between the phrases.
One commenter suggested the final rule should include the concept of "reasonable assurance" in making
certification decisions.

Agency's Response: The Agency declines to replace the term "will comply" with
"reasonable assurance" in section 121.7. While the 1971 Rule required a statement that
there was "reasonable assurance," 40 CFR 121.2(a) (2019), the 2020 Rule and this final rule
use the term "will comply" which is more consistent with the 1972 statutory language used
in sections 401(a)(1) and 401(d). Similar to the Agency's position in the 2020 Rule, the
Agency does not think that retaining the 1972 statutory language "will comply" in the

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regulations requires certifying authorities to provide absolute certainty that applicants for a
Federal license or permit will never violate water quality requirements. See 85 FR 42278
(July 13, 2020). This is not EPA's intention, and EPA does not think such a stringent
interpretation is required by the statutory or final regulatory language. The use of language
comparable to "will comply" is not uncommon in CWA regulatory programs. For example,
CWA section 402 contemplates that NPDES permits will only be issued upon a showing that
a discharge "will meet" various enumerated provisions of the CWA. 33 U.S.C. 1342(a). This
standard has not precluded states, Tribes, or EPA from routinely issuing CWA compliant
NPDES permits to allow pollutant discharges, nor has it resulted in permits that are
impossible for permittees to comply with. See Section IV.F of the final rule for further
discussion on this topic, including reasons the Agency does not intend or expect the use of
the term "will comply" to limit or impact a certifying authority's ability to rely on such
modeling to support its certification decisions.

6.3.2 Adaptive Management Conditions

A few commenters asserted that adaptive management conditions are the same as "reopener" clauses and
that they are important to ensure water quality resources will be protected throughout the life of the
project if the project changes or conditions of the waters impacted by the project changes. One of these
commenters asserted that reopeners are adaptive management conditions that provide a bounded "if-then"
description of a future triggering event and associated responsive action and recommended that the final
rule should allow them. The commenter asserted that reopener clauses can reduce the number of
situations where a certifying authority may seek to modify an existing certification. The commenter also
distinguished the reopener clauses the 2020 Rule aimed to prevent from "if-then" reopener clauses that
provide a predictable process. The commenter also specifically discussed the use of such conditions in the
hydropower licensing context (e.g., certification conditions that require facility operators to get review
and approval of a dredging management plan prior to dredging operations associated with the dam).

Conversely, one commenter asserted that certifying authorities should not be able to add adaptive
management conditions to certifications, because such conditions would allow certifying authorities to
include reopener conditions that could lead to new conditions being incorporated into the Federal permit
long after the certification is issued, which the commenter argued would hinder investment in projects or
cause delays. Rather, the commenter argued that once the permitted activity is complete, the state has no
authority to impose late-arising conditions that spring into effect at some point in the future. However, the
commenter acknowledged that there may be scenarios in which it would be practical for certifying
authorities to include conditions that depend on unknown future events.

Agency's Response: The Agency disagrees that adaptive management conditions are the
same as "reopener" clauses. Reopener clauses purport to authorize a certifying authority to
"reopen" and modify a certification at a later date, sometimes due to the occurrence of a
specific event. As discussed at Section IV.I of the final rule preamble, certifying authorities
cannot "bootstrap" themselves greater authority to modify a certification beyond what is
authorized in this final rule at 121.10. On the other hand, adaptive management conditions
are set at the time the certification is granted and provide a concrete action that must occur

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in the event certain criteria are met. The text of an adaptive management condition does not
change after certification is granted. This promotes regulatory certainty, in contrast with a
unilateral modification pursuant to a "reopener" clause. For example, a condition may
require a project proponent to increase monitoring efforts or conduct remediation if the
baseline, routine monitoring established in the certification reveals an increase in a specific
pollutant due to the activity. To ensure project proponents and Federal agencies understand
and are able to implement any such adaptive management conditions, EPA recommends
that certifying authorities clearly define and explain in the certification document the basis
for these conditions and the circumstances in which adaptive management conditions would
require action by the project proponent (e.g., expectations for undertaking additional
planning and monitoring; thresholds triggering adaptive responses; requirements for
ongoing compliance). EPA has previously acknowledged the use of "adaptive management"
conditions in prior guidance, see, e.g., 2010 Handbook at 32 (rescinded in 2019).

EPA disagrees with commenter assertions that adaptive management conditions will hinder
investment in projects or cause delays. Rather, adaptive management conditions enable
projects to adapt to future water quality-related changes, as opposed to forcing
stakeholders to seek a modification or new certification. However, to be clear, EPA
emphasizes that—for purposes of section 401—certification conditions cannot "live on" past
the expiration of the Federal permit to which they attach, including adaptive management
conditions. Section 401(d) requires certification conditions to be incorporated into the
Federal license or permit. Accordingly, once the Federal license or permit expires, any
certification conditions incorporated into the Federal license or permit also expire. This
principle holds true regardless of the scope of section 401. However, it does not mean that
when a certifying authority considers whether to grant or deny certification, the certifying
authority is limited to considering only those aspects of the activity that will occur before
the expiration of the Federal license or permit. For example, if the certifying authority
determines that no conditions could assure that the activity, including post-expiration
aspects of the activity, will comply with water quality requirements, denial of certification
would be appropriate.

6.3.3 Denials Without Prejudice

A few commenters discussed whether the proposal would prevent a project proponent from resubmitting a
request for certification following a denial. One commenter noted that while the 2020 Rule provided that
a certification denial would not preclude a project proponent from submitting a new certification request
(at 40 CFR § 121.8), the proposal did not include a similar provision. The commenter suggested that EPA
is taking the position that a certification denial is always a permanent final action that is taken with
prejudice. The commenter asserted that if this is EPA's position, it would be a significant change from its
previous longstanding position affirmed by the 2020 Rule. The commenter requested that EPA clarify its
position. The commenter identified reasons why the commenter believes this position would be
problematic, including that it would be detrimental to certifying authorities and project proponents,
particularly in cases where certification is denied based on insufficient information. The commenter stated
that at least one state routinely issues denials without prejudice which are authorized under state law.

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Another commenter recommended that project proponents be able to resubmit a request for certification
following a denial of certification.

Agency's Response: EPA's removal of regulatory text regarding the effects of a denial of
certification has no impact on denials without prejudice. EPA continues to interpret section
401 as allowing denials without prejudice. Section 401(a)(1) provides that a Federal license
or permit may not be granted if certification is denied, but it does not speak to new requests
for certification following a denial of certification. Nothing in section 401, nor this final rule,
prohibits a project proponent from re-applying for certification if a certifying authority
denies its initial request.

6.3.4 Waivers

One commenter asserted that EPA's interpretation that section 401(a)(1) clearly indicated Congress's
intent to limit constructive waivers to situations where a certifying authority did not act was inconsistent
with Congress's broader focus on a one-year timeframe.

One commenter recommended revising the proposed rule provisions on waivers because it is inconsistent
with the commenter's state program. Specifically, the commenter noted that it may certify a general
permit and then later decide to issue an individual certification for a project that cannot meet the
requirements of the Federal general permit and/or water quality certification associated with it.

Agency's Response: The Agency disagrees that its interpretation of section 401(a)(1) and
constructive waiver is inconsistent with the reasonable period of time. Section 401(a)(1)
clearly indicates Congress's intent to limit constructive waivers to situations where a
certifying authority did not act within the reasonable period of time. As discussed in section
IV.D of the final rule preamble, a certifying authority and Federal agency may jointly agree
to set the reasonable period of time up to one year. 40 CFR 121.6(b). However, if they are
unable to reach agreement, it will default to six months. 40 CFR 121.6(c). Accordingly, if
the certifying authority fails or refuses to act in the agreed-upon or default reasonable
period of time, the certifying authority will constructively waive. Accordingly, section
121.9(a) of the final rule provides that "the certification requirement shall be waived only if
a certifying authority fails or refuses to act on a request for certification within the
reasonable period of time." See Section IV.F, G for further discussion on the Agency's
interpretation.

In response to the commenter asserting that the proposed rule's approach to waivers was
inconsistent with the commenter's state program, the Agency notes that nothing in this final
rule precludes a certifying authority from acting on a request for certification on a project
that no longer qualifies for coverage under a general permit and its associated certification
and now requires coverage under a different (individual) permit. If a project proponent is
required to obtain a new Federal license or permit because its project does not comply with
the requirements of the general permit, then the project proponent must seek a section 401

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water quality certification or waiver before that new Federal license or permit may be
issued.

6.3.5	Notification of Certification Decision

One commenter asserted that EPA did not specify in the proposal whether a certifying authority must
communicate its certification decision with a project proponent or Federal agency, and recommended that
EPA include a provision in the final rule that requires the certifying authority to provide the project
proponent and Federal agency a copy of the certification decision within five days of the decision.

Agency's Response: The Agency has added further discussion in the final rule preamble to
clarify that once a certifying authority acts on a request for certification, the certifying
authority should send the certification decision to the project proponent requesting
certification. See Section IV.F of the final rule preamble. However, the Agency declines to
add regulatory text requiring the certifying authority to provide the project proponent and
Federal agency with a copy of the certification decision within a certain timeframe. Section
401(a)(1) requires the project proponent, not the certifying authority, to provide the Federal
agency with the certification from a certifying authority. However, EPA encourages
certifying authorities to include Federal agencies on any certification decision transmittal to
the project proponent to ensure all parties have a clear, consistent understanding of the
status of the decision (e.g., copy the Federal agency point of contact on e-mail
correspondence).

6.3.6	Incorporating Conditions in a Federal License or Permit

One commenter commended the Agency for removing the 2020 Rule's approach to certification
conditions and instead requiring all conditions to be included. However, another commenter
recommended that EPA clarify that certification conditions must be incorporated into a Federal license or
permit and that the rule should include a requirement that Federal agencies should revise their applicable
regulations to accommodate EPA's new rule.

Agency's Response: Pursuant section 401(d), if a grant of certification includes conditions,
those conditions must be incorporated into the Federal license or permit. 33 U.S.C. 1341(d)
("Any certification provided under this section shall set forth any effluent limitations and
other limitations, and monitoring requirements necessary to assure that any applicant for a
Federal license or permit will comply with [sections 301, 302, 306, and 307], and with any
other appropriate requirement of State law set forth in such certification, and shall become
a condition on any Federal license or permit...") (emphasis added). Granting certification
with conditions means the Federal license or permit may be issued, provided the conditions
are incorporated into that Federal license or permit. See Section IV. F, G of the final rule
preamble for further discussion on incorporating certification conditions into Federal
licenses or permits.

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The Agency declines to include regulatory text requiring Federal agencies to review their
regulations. However, EPA expects that Federal agencies with existing section 401
implementing regulations will evaluate their regulations and guidance documents to ensure
consistency with this final rule. See Section IV.M of the final rule preamble.

6.4 Input Received on Prior Rulemakings

6.4.1 Input on the 2019 Proposed Rule

This sub-topic summarizes comments that were made on a previous proposed rulemaking and were
resubmitted by commenters in the docket for the 2022 proposed rule.

6.4.1.1 Contents of a certification decision

A few commenters expressed support for the proposed contents of a certification decision as described in
the 2019 proposed rule. One commenter expressed support for the 2019 proposed rule's definition of
certification and claimed this guidance appropriately ties certification approvals back to water quality
requirements. The commenter also stated support for the 2019 proposed rule's requirement that a
certifying authority may deny a certification if it is unable to certify that the proposed activity would be
consistent with applicable water quality requirements, as long as the project proponent has the proper
channels to supply necessary information.

Another commenter asserted that the 2019 proposed rule clarifies appropriate certification conditions and
removes ambiguity to ensure that section 401 decisions remain within the scope of the CWA. The
commenter asserted that states and Tribes have historically abused the certification process to include
unrelated and unenforceable conditions into section 401 decisions.

A few commenters indicated that they would like to see additional changes to the proposed contents of a
certification decision as described in the 2019 proposed rule. One commenter requested that the 2019
proposed rule be amended to clarify that a notice of denial should be in writing, identify the reasons for
denial related to water quality, and list any outstanding data or information gaps that prevent compliance
with applicable water quality requirements. The commenter further requested that states and Tribes
identify conditions that are clear, specific, and directly related to a state or Tribal water quality
requirement, and include citations to the relevant state or Tribal law requirement. Another commenter
asserted that the 2019 proposed rule's options for certifications decisions of grant, grant with conditions,
denial, and waiver, all threatened the integrity of the nation's waters. The commenter expressed support
instead for the 1971 Rule, which they argued respected state administrative procedures. The commenter
asserted that the 1971 Rule preserved cooperative federalism because it did not impose specific
requirements on the contents of a certification denial and provided only a few broad categories of
information that should be included when a certifying authority grants a certification.

A few commenters emphasized concerns regarding the impact of the 2019 proposed rule on certifying
authorities. One commenter expressed concern that the 2019 proposed rule imposed limitations on state
authority, in particular the requirement that each condition in an issued certification decision contain an

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explanation as to why it is necessary, along with the specific provision of law that authorizes it. Another
commenter asserted that the 2019 proposed rule's requirements for conditional approvals or denials were
unfair, stating that it should be the applicant's responsibility to show that a proposed project will comply
with water quality requirements rather than the state's responsibility to show how compliance might be
achieved. One commenter asserted that the 2019 proposed rule's information requirements for conditions
put undue burden on the certifying authority, claiming that with a more limited review timeframe, the
information requirements will further strain states' already limited time and resources. The commenter
further stated that requiring an explanation of what less stringent conditions could be applied implies that
states require certification conditions that are more stringent than necessary to comply with state water
quality requirements.

Agency's Response: See the Agency's Response to Comments in Section 6.2; see also Section
IV.F of the final rule preamble.

6.4.1.2	Denials with prejudice

A few commenters provided input regarding the 2019 proposed rule's approach to denials with prejudice.
One commenter expressed concern that the 2019 proposed rule removes the ability to "deny with
prejudice," asserting that this approach allowed a state to preserve resources that would otherwise be
demanded for review of similar certification requests, even if they determine that the project cannot
comply with applicable water quality standards. The commenter expressed further concern that the 2019
proposed rule removes the ability to withdraw and resubmit or extend time, stating that these tools give
states and applicants the ability to process and resolve complex situations. Another commenter requested
that the 2019 proposed rule be amended to acknowledge that a certifying authority's denial of
certification may be made with or without prejudice. The commenter stated that allowing certifying
authorities to indicate their willingness to consider additional information through subsequent requests
would likely avoid unnecessary litigation. The commenter claimed this approach would be an
improvement over the withdrawal-and-resubmission scheme, increasing opportunities for regulatory
cooperation. The commenter further requested that the 2019 proposed rule be amended to consider terms
that preclude the use of denials "with prejudice" to prevent states from using this as a tool to hamper
projects from being implemented.

Agency's Response: See the Agency's Response to Comments in Section 4.5 and Section
6.3.3; see also Section IV.F of the final rule preamble.

6.4.1.3	Waivers

One commenter expressed concerns that the 2019 proposed rule violates the Congressional intent behind
the waiver provision, claiming this was intended only to prevent "sheer inactivity" by the state. The
commenter provided a detailed history of the waiver provision to support their argument.

Agency's Response: See the Agency's Response to Comments in Sections 6.3.4 and 7.4; see
also Section IV.F of the final rule preamble.

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6.4.2

Pre-proposal Input from 2021

This sub-topic summarizes input that was received prior to the 2022 proposed rule and was resubmitted
by commenters in the docket for the 2022 proposed rule.

6.4.2.1	What it means "to act"

One stakeholder requested that the 2020 Rule be revised to specify that a project proponent's withdrawal
of a request for certification concludes the review and requires the submission of a new and complete
request for certification. The stakeholder asserted that this process would provide applicants with a way to
avoid denial of a request for certification if they lacked time to provide the necessary information.

Agency's Response: See the Agency's Response to Comments in Section 4.5 and Section 6.1;
see also Section IV.F of the final rule preamble.

6.4.2.2	Contents of a certification decision

A few stakeholders expressed support for the 2020 Rule requirement that certain information be included
for certifications that are issued with conditions and denials. One stakeholder asserted that these
provisions provide clarity, transparency, and regulatory certainty for applicants and certifying authorities,
stating that these provisions ensure that the certifications are implemented consistently. Another
stakeholder asserted that this information is essential for judicial review and that particularly in the case
of denials, a complete statement of the basis for denial is essential before a proponent pursues a new
certification request. One stakeholder expressed support for the proposed contents of the 2020 Rule and
requested that EPA maintain these provisions and commit to transparency and regulatory certainty.

One stakeholder requested that the 2020 Rule be revised to eliminate the requirement to cite specific
water quality requirements and provide a rationale for each condition. The stakeholder stated that the
information provided by a certifying authority when it issues a decision should be determined solely by
that certifying authority. The stakeholder argued that the 2020 Rule should also be amended to provide
the certifying agency with an opportunity to remedy deficiencies within a reasonable period of time after
certification. The stakeholder also expressed concern that it will take additional time to incorporate the
requirements of the 2020 Rule into each condition, resulting in delays in certification decisions.

Agency's Response: See the Agency's Response to Comments in Section 6.2; see also Section
IV.F of the final rule preamble.

6.4.2.3	Certification conditions

One stakeholder expressed concern regarding the 2020 Rule's removal of adaptive management
conditions. The stakeholder stated that states and Tribes must be able to place conditions that allow for
the re-opening of certifications if circumstances change and different measures are needed to protect
waters, particularly with respect to climate change. Referencing Executive Order 13990, the stakeholder
further claimed that given the challenge of climate change, states' and Tribes' authority to impose

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conditions that protect water quality through certifications is even more important, citing examples of
potential impacts to environmental justice communities and fisheries. The stakeholder further stated that
the impacts of the 2020 Rule are evident in recent certifications, citing three examples of 401
certifications for new dam projects in Colorado, each of which they claimed included conditions that
would likely not be permitted under the 2020 Rule.

Agency's Response: See the Agency's Response to Comments in Section 6.3.2; see also
Section IV.F of the final rule preamble.

6.4.2.4 Waivers

A few stakeholders provided input regarding the use of waivers in the 2020 Rule. One stakeholder
requested that the 2020 Rule specify that a waiver only occurs on the date of a Federal agency's written
notification to the project sponsor and certifying authority. The stakeholder argued that the 2020 Rule
shortened the reasonable period of time for review and created unnecessary procedural requirements,
asserting that this would increase the likelihood of certifying authorities inadvertently waiving their
Section 401 authority.

Another stakeholder asserted that the waiver provisions of the 2020 Rule were unlawful, claiming that
they remove the authority of states and Tribes to protect their waters and implement an unlawful scope of
certification and definitions of discharge and water quality requirements. The stakeholder claimed that
Congress did not intend for a denial of a certification to be turned into a waiver, citing several Federal
court cases in support of their argument. The stakeholder also asserted that the 2020 Rule would permit
Federal permitting authorities review and reject certification conditions or denials, counter to Congress'
intentions.

Agency's Response: See the Agency's Response to Comments in Sections 5,6.3.4, and 7.4;
see also Section IV.F and G of the final rule preamble.

7. Federal Agency Review (Sections 121.8-121.9)

7.1 Support Proposed Approach to Federal Agency Review (In All Or Part)

7.1.1 General Support for Proposed Approach

Several commenters agreed with limiting the 2020 Rule's scope of Federal agency review, with some of
these commenters supporting all four of the proposed section 121.9 review provisions. One commenter
suggested that the scope of Federal agency review should be limited to ensuring the certification decision
was made within the reasonable period of time only. One commenter said that the proposed approach
removes the Federal agency's ability to second guess a certifying authority's decision, and another
commenter stated that the Federal government cannot supplant its judgement for the judgement of the
state or Tribe as the Federal review. Some of these commenters noted that the proposed scope of Federal
agency review restores the cooperative federalism intended by the statute. In expressing support for the
proposed approach, one commenter asserted that it is clear in section 401 that states and Tribes should be

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able to condition permits that the Federal agency and permit applicant need to meet. A few commenters
wrote in favor of the proposed rule's limited "ministerial" role for Federal agencies.

Agency's Response: EPA agrees that Federal agency review is limited in nature, and the
Agency is finalizing regulatory text at section 121.8 to affirmatively limit Federal agency
review to verifying compliance with the facial requirements of CWA section 401. The
Agency is revising the proposed list of factors that a Federal agency may review, including
removing the first factor (the nature of the decision) from the final regulatory text. See
Section IV.F of the final rule preamble for further discussion on the final rule's approach to
Federal agency review.

7.1.2 Comparison to the 2020 Rule

Commenters who critiqued the 2020 Rule's provision on Federal agency review wrote in support of the
proposed rule, generally arguing that the proposed rule is more consistent with case law and the CWA
than the 2020 Rule. One commenter provided a detailed discussion of the history of the CWA and
precursor language to Section 401 in the Water Quality Improvement Act of 1970 in support of their
argument.

Most of these commenters specifically argued against Federal agencies' authority to deem non-compliant
certification decisions waived, arguing that it was inconsistent with case law and the CWA (citing Sierra
Club v. U.S. Army Corps of Engineers, 909 F.3d 635, 645 (4th Cir. 2018); United States v. Marathon Dev.
Corp., 867 F.2d 96, 101 (1st Cir. 1989)). A few commenters generally argued that allowing Federal
agencies to determine constructive waiver for issues besides late certification contradicts the CWA's plain
language that conditions of a section 401 certification "shall become" conditions of the federal permit (33
U.S.C. 1341(d)) and undermines the CWA framework of cooperative federalism. Another commenter
argued that Federal agencies are without the requisite legal authority and expertise to review certification
decisions. One commenter critiqued the 2020 Rule for what the commenter characterized as "ambiguity"
in defining the role of Federal agencies.

Several commenters noted that Section 401 does not give Federal agencies the authority to nullify, reject,
"veto" or "override" a certifying authority's water quality certificate or conditions. Some of these
commenters asserted that courts have affirmed that certifying authorities can include conditions within a
certification and that Federal agencies do not have the authority to ignore these conditions. One of these
commenters stated that any substantive review of certification decisions that could result in the Federal
agency overriding or ignoring the decision should be expressly prohibited. This commenter further stated
that should a Federal agency refuse to include certification conditions, then the result should be an
automatic approval of the Federal license or permit that incorporates the certification conditions. A couple
of commenters stated that the proposed rule is a necessary correction to ensure that Federal agencies do
not have the authority to veto conditions or limit the ability of certifying authorities to deny certification
to projects that fail to comply with water quality standards.

One commenter cited specific examples of the U.S. Army Corps of Engineers' certification process for
the 2020package of section 404 Nationwide General Permits (NWPs) asserting that the Corps

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misinterpreted certifying authorities' conditions as reopener clauses. A few other commenters discussed
experience with the 2020 Rule and Federal agency review. One commenter asserted that many states and
Tribes found the 2020 Rule's documentation requirements to be burdensome and with limited water
quality benefit. The commenter stated that the 2020 NWP review process demonstrated the problem with
the 2020 Rule's approach, asserting that many Corps districts reviewed the substance of some
certification conditions and led to a process that was not predictable, transparent, or consistent and
resulted in substantive changes to certifications not envisioned by the CWA. The commenter also asserted
that some certifying authorities whose conditions on the NWPs were rejected were subjected to a Corps'-
established new category of action ("decline to rely on") that was not provided in section 401. The
commenter stated that a certifying authority denied certification on seven Corps NWPs, but the Corps,
relying on the 2020 Rule, found that the certifying authority waived its right to certify because it failed to
identify the specific water quality requirements at issue and explain how the relevant discharges would
not comply with these requirements. According to the commenters, the certifying authority was unable to
remedy the issue for three of the seven permits.

Agency's Response: EPA agrees with commenters that section 401 does not give Federal
agencies the authority to nullify or reject a certifying authority's water quality certification
or conditions and that courts have affirmed that Federal agencies do not have the authority
to ignore conditions of certification. Accordingly, the Agency is finalizing regulatory text at
section 121.8 to clarify that Federal agency review is limited to verifying compliance with
the requirements of CWA section 401. Aside from the three elements listed at section 121.8,
EPA concludes that Federal agencies lack the authority to review other aspects of a
certification decision for purposes of determining whether a "certification required by
[section 401] has been obtained or has been waived." 33 U.S.C. 1341(a)(1). Additionally,
section 121.8 clarifies that a Federal agency may only determine that a certifying authority
inadvertently waived where a certifying authority fails or refused to act within the
reasonable period of time. As discussed in the final rule preamble, the final rule approach to
Federal agency review represents the best reading of the text of section 401, Congressional
intent, and relevant case law, and incorporates recommendations from public comments
received on the proposed rule. For further discussion of the Agency's analysis of the
statutory text, Congressional intent, and relevant case law, see Section IV.G of the final rule
preamble.

The Agency appreciates commenter input regarding experiences with the 2020 Rule's
Federal agency review provision. The Agency finds that stakeholder experiences with
constructive waivers under the 2020 Rule and the Corps' Nationwide General Permits are
one example of how the 2020 Rule failed to appropriately address adverse impacts to state
and Tribal water quality. As discussed in section IV.F in the final rule preamble, the
Agency recognizes that a constructive waiver is a severe consequence; a waiver means that a
Federal license or permit that could adversely impact the certifying authority's water
quality (i.e., cause noncompliance with water quality requirements) may proceed without
any input from the certifying authority.

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7.1.3

Comments on Certification Decision Type (proposedSection 121.9(a)(1))

One commenter suggested that proposed section 121.9(a)(1) is not necessary because the decision should
be apparent on its face.

Agency's Response: In response to public comment, the Agency is not finalizing the
regulatory text proposed at section 121.9(a)(1), which provided that a Federal agency may
also review a certification decision to confirm the nature of the decision (Le., whether the
certification decision is a grant, grant with conditions, denial, or express waiver). The
Agency does not disagree with this aspect of the proposal, but the Agency finds the
regulatory text unnecessary and somewhat confusing when listed among the other
components of Federal agency review. Certainly, a Federal agency needs to look at the
certification decision to determine how it should act in response. For instance, the Federal
agency cannot issue the relevant license or permit if the certification decision is a denial. If
the decision is a grant with conditions, the Federal agency must include those conditions in
its license or permit. However, looking at the certification document to see how the
certifying authority decided to act represents a different sort of "review" than the other
components of Federal agency review identified in section 121.8. The other components all
concern verifying compliance with the statutory requirements of section 401. EPA
concluded that it is best to remove this provision to avoid confusion.

7.1.4 Comments on The Public Notice Provision (121.9(a)(3))

Some commenters noted that public notice procedures vary amongst certifying authorities. One
commenter noted that establishing generally applicable procedures for public notice is not necessarily the
same as providing public notice on every application. This commenter suggested that EPA allow states to
affirm compliance with their own public notice requirements, rather than mandate demonstration of
public notice on all section 401 requests.

A couple of commenters suggested that Federal agency review of public notice requirements should not
be included in the final rule because it goes beyond the facial requirements of the statutory text. One of
these commenters further stated that Federal agencies have little knowledge of the public notice
procedures of certifying authorities, and that any issues with the procedural process would be addressed in
state court.

One commenter noted that Federal agency review of public notice requirements is not necessary in
instances where a certification decision is a "grant" without conditions because there are no water quality
requirements included.

Agency's Response: EPA agrees with commenters that public notice procedures vary
amongst certifying authorities and that establishing generally applicable procedures for
public notice is not necessarily the same as providing public notice on every application.
Section 401(a)(1) requires a certifying authority to establish procedures for public notice,
and a public hearing where necessary, on a request for certification. 33 U.S.C. 1341(a)(1).

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Accordingly, EPA has revised the regulatory text, now located at section 121.8, to better
reflect the statutory text and to clarify that a Federal agency may review whether the
certifying authority confirmed it complied with its public notice procedures.

EPA disagrees with commenters asserting that Federal agency review of public notice
requirements goes beyond the facial requirements of the statutory text. EPA acknowledges
that the text of section 401 does not explicitly define a role for Federal licensing or
permitting agencies to review certification decisions. However, the Agency has long
recognized, both in regulation and guidance, some degree of appropriate Federal agency
review of certification decisions. Additionally, courts have generally found that Federal
agencies may review certification decisions only to see whether the decision satisfies the
facial statutory requirements of section 401, including whether public notice procedures
were followed.

While EPA agrees that questions regarding compliance with specific state public notice laws
and regulations would be addressed in state proceedings, EPA disagrees that it is therefore
inappropriate for a Federal agency to seek verification from the certifying authority that it
complied with its public notice procedures, a Federal statutory requirement. The Agency
appreciates commenter concerns regarding a Federal agency's lack of substantive
knowledge about a certifying authority's public notice procedures. Therefore, the Agency is
limiting Federal agency review regarding public notice to simply verifying that the
certifying authority confirmed it complied with its public notice procedures. This should not
require the Federal agency to delve into any specifics regarding a state or Tribe's public
notice procedures, but rather should entail merely asking the certifying authority to provide
confirmation of its compliance. To aid in this review, EPA recommends that certifying
authorities indicate compliance with their public notice procedures in the certification
decision.

In response to the commenter who asserted that Federal agency review of compliance with
public notice requirements is unnecessary for a grant of certification, EPA disagrees.
Neither the statutory text nor case law suggest that certain types of certification decisions
are categorically exempt from Federal agency review. However, the Agency notes that the
final rule allows Federal agencies to review specified aspects of a certification decision but
does not require such review. See Section IV.G of the final rule preamble.

7.2 Support 2020 Rule Approach to Federal Agency Review

Several commenters wrote in support of the 2020 Rule's approach to Federal agency review. These
commenters argued that the proposed rule should retain the Federal agency authority to evaluate required
explanatory statements in certification denials and statements and in their absence, to determine that
certification or the certification condition had been waived. These commenters argued that Federal
agencies are obligated to determine if procedural requirements have been met and warned that without
Federal oversight, certifying authorities would have little incentive - and might be disincentivized - to
provide the supporting information (citing Hoopa Valley Tribe, 913 F.3d at 1103-05; City ofTacoma v.

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FERC, 460 F.3d 53, 67-69 (D.C. Cir. 2006), Jackson Cnty. v. FERC, 589 F.3d 1284, 1289 (D.C. Cir.
2009); Keating v. FERC, 927 F.2d 616 (D.C. Cir. 1991)).

A few commenters argued that removing Federal agency oversight would create a structure that could be
misused by certifying authorities to deny otherwise federally approved projects. One commenter argued
that section 401 has been misused by certifying authorities to pursue policy objectives unrelated to water
quality, and that this misuse can wield a disproportionate level of decision-making authority over a wide
variety of interstate projects and projects of national importance. This commenter suggested that Congress
intended to limit the scope and duration of section 401, and that the principles of cooperative federalism
do not dictate that certifying authorities receive as much authority and autonomy as possible. This
commenter opposed eliminating Federal agency oversight over the substance of certification decisions or
certifying authorities' compliance with statutory and regulatory requirements applicable to certification
decisions.

One commenter asserted that the 2020 Rule's approach to Federal agency review served to police
certifying authority compliance with EPA's procedural rules through a mechanism that is quicker and less
costly than judicial review. Similarly, another commenter argued that the lack of certification condition or
denial review to ensure their validity will add unnecessary time and costs to projects because judicial
review will be the only avenue for any recourse. A commenter asserted that removing Federal agency
review of certifications or certification conditions will provide project proponents little to no timely
recourse for challenging a certification decision, as the project proponent is only able to challenge the
certification decision in an appropriate court. The commenter recommended that EPA adopt an approach
where the certifying authority and project proponent proceed to arbitration for a period of 60 days when
certification is denied or there is disagreement about certification conditions, and after that period the
project proponent can move for judicial review if there is no settlement agreement. The commenter argues
that this approach would enhance cooperation and coordination between stakeholders and could reduce
litigation and extended delays for projects.

Agency's Response: See Section IV.G.2 of the final rule preamble for responses to these
comments.

In response to the commenter who recommended that the Agency develop an arbitration
process for certification denials or disagreements about certification conditions, the Agency
declines to adopt the commenter's suggestion. The Agency has encouraged coordination
and communication throughout the final rule, and similarly encourages communication
between project proponents and certifying authorities about proposed certification
decisions and certification conditions when such communication has the potential to avoid
litigation. EPA even encourages communication regarding finalized certification conditions
if there is an opportunity for modification consistent with this final rule that would avoid
litigation. However, EPA declines to mandate in this final rule an automatic 60-day
arbitration period. This offers flexibility that reflects cooperative federalism and the reality
that not every dispute is amenable to arbitration. Further, as discussed in the final rule
preamble, Congress recognized that state courts were the proper venue for any issues or
concerns surrounding the substance of a certification decision. See, e.g., H.R. Rep. No. 91-

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940, at 55-56 (March 24,1970) ("If a State refuses to give a certification, the courts of that
State are the forum in which the applicant must challenge that refusal if the applicant
wishes to do so."); S. Rep. 92-414, at 1487 (October 28,1971) ("Should such an affirmative
denial occur no license or permit could be issued by such Federal agencies as the Atomic
Energy Commission, Federal Power Commission, or the Corps of Engineers unless the
State action was overturned in the appropriate courts of jurisdiction."); H.R. Rep. 92-911,
at 122 (March 11,1972) ("If a State refuses to give a certification, the courts of that State
are the forum in which the applicant must challenge the refusal if the applicant wishes to do
so.").

7.3 Do Not Support Federal Agency Review at All

A few commenters recommended removing Federal agency review of any certification decisions from the
final rule, with one commenter arguing that Federal agency review erodes cooperative federalism
principles, and the other noting that Federal agency review is unwarranted by the statutory text. A few
commenters noted that Section 401 does not define a role for Federal agency review of certification
decisions. One commenter supported EPA's decision to remove Federal agency review and waiver of a
certification decision due to procedural defects.

A couple of commenters argued that the additional oversight provided by Federal agency review of
certification decisions is inefficient and ineffective for routine projects with minimal impacts. One of
these commenters further suggested that the project proponent should decide which projects receive
additional oversight because the project proponent is most capable of understanding cases where
oversight is needed. A few commenters stated that procedural technicalities are not a basis for an
involuntary or implicit waiver of certification.

Agency's Response: EPA acknowledges that the text of section 401 does not explicitly define
a role for Federal licensing or permitting agencies to review certification decisions.
However, the Agency has long recognized, both in regulation and guidance, some degree of
appropriate Federal agency review of certification decisions. Additionally, as discussed in
section IV.G.2 of the final rule preamble, a few courts have acknowledged a limited role for
Federal agencies to ensure that a certifying authority meets certain requirements of section
401. The Agency disagrees that this final rule's approach to Federal agency review would
erode cooperative federalism principles or prove inefficient for projects. Rather, the final
rule recognizes a Federal agency's legitimate interest in receiving a certification in
accordance with section 401 to lawfully proceed with its licensing and permitting process.

EPA disagrees with the commenter suggesting that project proponents should determine
which projects receive Federal agency review. Neither the statutory text nor case law
support a decisive role for project proponents in determining what projects are subject to
Federal agency review. See Section IV.G for further discussion on the Agency's analysis of
the statutory text and case law addressing Federal agency review.

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EPA agrees with commenters that a constructive waiver occurs only where a certifying
authority fails to act on a request for certification (i.e., grant, deny, expressly waive) within
the reasonable period of time. See Section IV.F and G for further discussion on when
constructive waiver occurs.

7.4	Waiver for "Reasonable Period of Time" Passage Only

Some commenters expressed support for the position in the proposal that constructive waiver may occur
only when the certifying authority fails or refuses to act (i.e., to grant, grant with conditions, deny, or
expressly waive) within the reasonable period of time. One commenter stated that section 401 only allows
for a waiver when a certifying authority fails or refuses to act on a request for certification within a
reasonable period of time.

Agency's Response: EPA agrees with commenters that a constructive waiver occurs only
where a certifying authority fails to act on a request for certification (i.e., grant, deny,
expressly waive) within the reasonable period of time. The Agency recognizes that a
constructive waiver is a severe consequence; as discussed in section IV.F in the final rule
preamble, a waiver means that a Federal license or permit which could adversely impact
the certifying authority's water quality (i.e., cause noncompliance with water quality
requirements) may proceed without any input from the certifying authority. EPA
encourages Federal agencies, project proponents, and certifying authorities to communicate
early and often to prevent inadvertent waivers due to passage of time. For example, a
Federal agency could set up an MOA or other agreement with certifying authorities to
establish notification protocols prior to finding a waiver of certification (e.g., where a
certifying authority has not acted by 30 days prior to the end of the reasonable period of
time, the Federal agency will notify the certifying authority that a waiver will occur if it
does not receive a certification decision or a request to extend the reasonable period of time
in that 30 day period).

7.5	Demonstrating Compliance with Elements in Proposed Section 121.9

One commenter explained that the Federal agency should be able to confirm three elements from the
certification decision without any additional input from the certifying authority. Similarly, another
commenter stated that it should only take minimal effort by a certifying authority to demonstrate
compliance. Another commenter suggested that operating agreements between the certifying authority
and Federal agency may be used to identify how the certifying authority can demonstrate that it met the
section 401 facial requirements. The commenter explained that this would reduce the need for
coordination on each individual certification decision. The commenter, a certifying authority, explained
that it had an existing operating agreement with the Corps that could be adapted to this effect.

A few of these commenters also provided suggestions for demonstrating compliance with proposed
section 121.9 or clarifying the review. One commenter suggested that EPA make it clear that Federal
agency review of a certification decision for whether it indicates the nature of the decision does not
require a determination that the decision contains all the required contents. Another commenter

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recommended that the certifying authority should provide a copy of the public notice with the
certification to satisfy proposed section 121.9(a)(3). Similarly, another commenter, a certifying authority,
noted that it sends a copy of its public notice to the Federal agency, which the commenter asserted will
provide the Federal agency with confirmation that public notice requirements were appropriately met.
A different commenter that acts as a certifying authority explained that it typically includes a description
of its public notice process in its certification decisions. The commenter asserted that this description
should be sufficient such that no further inquiry regarding public notice is necessary. The commenter
stated that, at most, the final rule could allow a Federal agency to obtain an assertion of compliance with
public notice procedures.

Agency's Response: Consistent with the proposed rule, EPA is declining to define the
specific information a certifying authority must include in a certification decision to
demonstrate compliance with the facial requirements of section 401. Section 401 does not
expressly address what specific information certifying authorities must include in a
certification decision, nor does it address the process of Federal agency review. While the
statute does contain important information about the identity of the appropriate certifying
authority, the length of the reasonable period of time, and a requirement for public notice
procedures, it does not prescribe how a certifying authority must demonstrate compliance
with those requirements. Certifying authorities are the entities most familiar with their
certification process, and certifying authorities, and not EPA or other Federal agencies, are
in the best position to determine how to demonstrate compliance. EPA finds that the
approaches described by commenters (providing a copy of the public notice in the
certification decision or including a description of the public notice process it undertook in
its certification decision) are sufficient to satisfy Federal agency review. In fact, it would be
sufficient for the certifying authority to simply state in its certification decision that the
certifying authority complied with its public notice procedures. EPA expects that it should
only take minimal effort by a certifying authority to demonstrate compliance for Federal
agency verification.

See Section IV.G of the final rule preamble for the Agency's recommendations, based on
commenter input, on ways certifying authorities could demonstrate compliance with the
facial requirements of section 401.

7.6 Ability to Remedy Deficiencies

7.6.1 Opportunity to Remedy

Almost all commenters that commented on certifying authority ability to remedy deficient certification
decisions expressed support for proposed 40 CFR 121.9(b) that if the Federal agency determines that
certain facial requirements (e.g., public notice) have not been met, it must provide the certifying authority
with an opportunity to remedy the situation. Many commenters agreed with the proposal's
characterization of constructive waiver as a "severe consequence."

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Agency's Response: Upon further reconsideration, the Agency is declining to include
regulatory text addressing the potential consequences and remedies to deficient certification
decisions, aside from failure or refusal to act within the reasonable period of time. As
discussed in Section IV.G of the final rule preamble, this restores the Agency's pre-2020
Rule approach to Federal agency review and avoids unnecessarily encumbering the
certification process with more procedure. See Section IV.G of the final rule preamble for
further discussion on why the Agency is declining to define the process that a Federal
agency and certifying authority must follow if the Federal agency's review reveals that the
wrong certifying authority issued the certification decision, or the Federal agency was
unable to obtain confirmation that the certifying authority complied with its public notice
procedures and why other aspects of this final rule should prevent the need for specific
EPA-mandated process to remedy deficiencies identified through Federal agency review.

EPA agrees with commenters that a constructive waiver occurs only where a certifying
authority fails to act on a request for certification (i.e., grant, deny, expressly waive) within
the reasonable period of time. The Agency recognizes that a constructive waiver is a severe
consequence; as discussed in Section IV.F in the final rule preamble, a waiver means that a
Federal license or permit which could adversely impact the certifying authority's water
quality (i.e., cause noncompliance with water quality requirements) may proceed without
any input from the certifying authority. EPA encourages Federal agencies, project
proponents, and certifying authorities to communicate early and often to prevent
inadvertent waivers due to passage of time. For example, a Federal agency could set up an
MOA or other agreement with certifying authorities to establish notification protocols prior
to finding a waiver of certification (e.g., where a certifying authority has not acted by 30
days prior to the end of the reasonable period of time, the Federal agency will notify the
certifying authority that a waiver will occur if it does not receive a certification decision or a
request to extend the reasonable period of time in that 30 day period).

7.6.2 Extension of the "Reasonable Period of Time "for Remedy

Most commenters expressed support for Federal agencies extending the reasonable period of time to
allow for correction of deficiencies up to the statutory one-year limit. One commenter urged EPA to
require the Federal agency to extend the reasonable period of time if the Federal agency finds that the
certifying authority has not acted within the agreed upon or default reasonable period of time, as long as
the maximum one-year period has not yet been exceeded. The commenter noted that the proposal
encouraged Federal agencies to extend the reasonable period of time instead of finding waiver. However,
the commenter interpreted the statutory text of section 401(a) as prohibiting a finding of constructive
waiver until the one-year period has been exceeded. The commenter also asserted that finding
constructive waiver before the maximum one-year period is not fitting with the cooperative federalism
and the co-regulatory design of the CWA. Another commenter stated that it supported a general time
frame of at least sixty (60) days to remedy a deficient certification when the one-year timeframe has not
expired, but noted that Federal and certifying authorities should have the flexibility to set mutually
agreeable deadlines to address deficiencies. Another commenter suggested that EPA amend proposed
section 121.9(c) to clearly provide Federal agencies with discretion to determine whether a constructive

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waiver has occurred where the certifying authority inadvertently failed to issue a certification decision
within the reasonable period of time, and require Federal agencies to extend the reasonable period of time
so long as it does not exceed one year. The commenter asserted that its suggested revisions would
effectuate EPA's intent as expressed in the preamble and further cooperative federalism goals. Otherwise,
the commenter argued that the proposed language directly conflicts with EPA's statements in the
preamble and cooperative federalism.

A couple of commenters recommended that the final rule should allow certifying authorities to correct
errors even after the reasonable period of time has ended. One of these commenters suggested that EPA
allow states and Tribes to remedy issues with 401 certification decisions after the reasonable period of
time, even if more than one year after the certification request, so long as the state or Tribe acted "in good
faith" and took some "significant and meaningful action" within the reasonable period of time, not to
exceed one year. The commenter made this suggestion in the context of waivers for non-compliance. This
commenter referred to the N. C. Dept of Envtl Quality v. FERC case and the text of section 401 as in
support, and argued that state and Tribal ecosystem, community, and water resource protection should be
prioritized over inflexible procedures and rules that could lead to what the commenter characterized as
unfairness by removing state and Tribal authority because of errors.

A commenter stated that the proposal did not provide a timeline for the Federal agency to issue notice of
the deficiency or a timeline for the certifying authority to remedy the deficiency. The commenter also
questioned what happens if a deficient certification or denial is issued on day 364 of the reasonable period
of time. The same commenter also asserted that it is unreasonable to allow an opportunity for remedy
where the certifying authority fails to clearly indicate if they are issuing or denying a certification.

One commenter urged EPA to reconsider requiring automatic extensions of the reasonable period of time
as necessary to allow the certifying authority with an opportunity to remedy any deficiency. The
commenter explained that it does not oppose small extensions of time for certifying authorities to provide
additional detail or make minor changes necessary to satisfy the elements. However, the commenter
expressed concern that certifying authorities may abuse this extension process by submitting purposely
incomplete decisions. According to the commenter, if a certifying authority submits a clearly deficient
certification decision, the certifying authority should not be entitled to more time; instead, the certification
should be waived. The commenter argued that this approach would promote timely certification
decisions, minimize exploitation of time extensions, and encourage certifying authorities to submit
complete certification decisions. Another commenter suggested that corrections should be made within
the reasonable period of time and be limited to "errors made in good faith." This commenter cautioned
that this provision should not allow or incentivize certifying authorities to ignore procedures or take more
time.

One commenter expressed concern over preamble language encouraging Federal agencies to extend the
reasonable period of time where a certifying authority inadvertently waives certification, asserting that the
proposal did not explain what would qualify as an inadvertent waiver or how a Federal agency would
document such, and questioned how EPA could authorize the Federal agency to ignore the statute. The
commenter asserted that section 401 clearly provides that if a reasonable period of time is established and

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the certifying authority does not act within that reasonable period of time then waiver has occurred, and
EPA cannot create a regulatory override over clear statutory language.

Agency's Response: See the Agency's Response to Comments at Section 7.6.1.

The Agency disagrees with the commenter asserting that section 401 prohibits a finding of
constructive waiver until the one-year period has been exceeded. This final rule requires a
certifying authority to act within the reasonable period of time as determined pursuant to
final rule section 121.6, which may be less that the statutory maximum of one year. This is
consistent with the statutory text and the Agency's 1971 Rule and 2020 Rule. For further
discussion about constructive waivers due to passage of time, see Section IV.F, G of the final
rule preamble and the Agency's Response to Comments in Section 6.3.4.

7.6.3 Federal Agency Notification

A few commenters offered recommendations regarding the process surrounding Federal agency
notification of a deficiency and an opportunity to remedy. A couple of commenters recommended that the
final rule require the Federal agency to immediately notify the certifying authority after a deficiency is
identified, as opportunities to modify an existing certification or correct certification deficiencies can help
avoid delays and ensure consistency between Federal licenses and water quality goals. One of these
commenters also recommended that the reasonable period of time be stopped when the certifying
authority submits its certification, and that remaining time within the reasonable period of time or one
year be available for remedying the deficiency. Another commenter recommended that Federal agencies
develop procedures providing how a certifying authority should respond to a Federal agency's notice
regarding deficiencies. The commenter also recommended that the Federal agencies provide a letter to the
certifying authority stating the deficiencies, the specific rule regarding the deficiency, and a timeframe to
correct or respond to the deficiency.

One commenter recommended that the final rule should require the Federal agency to promptly notify the
certifying authority of a finding of constructive waiver due to the passage of time. Another commenter
requested that the final rule specify that waiver occurs only on the date of a Federal agencies written
notification to the project proponent and certifying authority. Another commenter recommended that the
final rule provide instructions to Federal agencies about reaching out to certifying authorities about the
lack of action on a certification prior to finding constructive waiver. One commenter, a project proponent,
noted that it has experienced a few cases where the Federal agency found that the certifying authority
waived certification under the 2020 Rule because the certifying authority did not act before the end of the
reasonable period of time.

One commenter described the notification requirements under 40 CFR 121.9 and suggested including a
requirement that the Federal agency notify the certifying authority that the certification has been received
within the reasonable period of time, and the certification conditions have been incorporated into the
relevant license or permit.

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Agency's Response: Under the final rule, if a Federal agency determines that the
certification decision was not issued within the reasonable period of time, the Federal
agency shall promptly notify the certifying authority and project proponent in writing that
a waiver has occurred. Similar to the 2020 Rule, see section 121.9(b) of the 2020 Rule, the
Agency is also finalizing regulatory text that clarifies that such notification from the Federal
agency satisfies the project proponent's requirement to obtain certification. 40 CFR
121.9(b). The Agency made minor revisions to the text proposed at section 121.9(c) to clarify
that a waiver only satisfies the project proponent's obligation to obtain a certification and
does not satisfy any other obligations under section 401 (e.g., need to provide the Federal
agency supplemental information pursuant to section 121.12). However, the Agency is
declining to finalize regulatory text on the process that Federal agencies and certifying
authorities must follow for non-compliance with other facial requirements of CWA section
401 including potential consequences and remedy procedures. This is consistent with the
Agency's approach to Federal agency review prior to the 2020 Rule and avoids
unnecessarily encumbering the certification process with additional procedures. See the
Agency's Response to Comments at Section 7.6.1.

EPA encourages Federal agencies, project proponents, and certifying authorities to
communicate early and often to prevent inadvertent waivers due to passage of time. For
example, a Federal agency could set up an MOA or other agreement with certifying
authorities to establish notification protocols prior to finding a waiver of certification (e.g.,
where a certifying authority has not acted by 30 days prior to the end of the reasonable
period of time, the Federal agency will notify the certifying authority that a waiver will
occur if it does not receive a certification decision or a request to extend the reasonable
period of time in that 30 day period).

7.7 Input Received on Prior Rulemakings

7.7.1 Input on the 2019 Proposed Rule

This sub-topic summarizes comments that were made on a previous proposed rulemaking and were
resubmitted by commenters in the docket for the 2022 proposed rule.

A commenter asked EPA to restore original jurisdictional language in the CWA to define the roles of the
state and Federal government.

A commenter stated that Federal agencies should review conditions when called upon to do so, and that
EPA should explicitly recognize that the Federal agency's review of certification conditions is focused on
conditions that are called into question by the project proponent. This commenter also said that Federal
agencies should have the authority to make waiver determinations and evaluate the validity of section 401
certification, and the commenter stated that EPA should encourage lead Federal agencies to consult with
other Federal agencies with expertise on the proposed discharge or activity on whether the actions (e.g.,
conditions and denials) of the certifying authority facially comply with section 401. The commenter

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further said that EPA should clarify the process by which Federal agencies may evaluate whether a
certifying authority's actions are beyond the scope of section 401.

One commenter said that EPA should clarify that where a project requires multiple Federal
authorizations, the "lead" Federal agency is responsible for carrying out the section 401 responsibilities
(i.e., setting the reasonable period of time for the certifying agency to make a decision, determining
waiver, etc.) and that all other Federal agencies should defer accordingly. The commenter also
recommended that EPA clarify that where the lead Federal agency determines that waiver has occurred
the certification requirement "falls out of the equation" and all other Federal agencies can and should
move forward with processing their reviews and authorizations. The commenter stated that EPA should
clarify that the lead Federal agency's written notification of waiver should also be provided to the other
Federal agencies.

One commenter said it supports that it is the Federal agency's role to determine whether a waiver has
occurred and that waiver can occur when a certifying authority expressly waives or fails to act within a
reasonable period of time. The commenter stated that the Federal agency has the authority to determine
whether the proper certifying authority issued the certification and if done so timely. The commenter also
said that if a condition does not satisfy the requirements, the condition should not be included in the
Federal license or permit, and they stated Federal agencies have the authority to reject certifications or
conditions that are not consistent with the requirements or limitations of section 401.

A commenter said that the lead Federal agency should respect the sovereignty and expertise of states,
with a not required and discretionary review of state certification conditions. The commenter added that
the review of the state certification conditions should be limited to their validity under the proposed
changes and that Federal agencies do not have the authority to condition a project after a certifying
authority's review or overturn a state's certification denial.

Some commenters expressed concern about the 2019 proposed rule's Federal agency review requirement
and said that Federal agencies do not have the authority to override a state's certification decision. One
said that the 2019 proposed rule would substitute a state's judgement for the judgement of Federal
agencies by providing Federal agencies with the ability to veto specific conditions, solely enforce
conditions, and find waiver even if a state acts within the reasonable period of time. A few of these
commenters stated that section 401 does not allow Federal agencies to issue Federal permits or licenses if
a state has denied certification and that EPA's 2019 proposed rule did not provide support for how
Federal agencies have authority to substantively review state-imposed conditions to determine if they
complied with EPA's interpretation of the scope of review. One commenter said that the 2019 proposed
rule also did not give certifying authorities the opportunity to remedy any parts of their certification
decision that the Federal agency found inconsistent with the proposed changes.

Referring to the 2019 proposed rule, one commenter stated that Federal agencies would be allowed to
disregard a states' timely denials or conditions, despite timely denials and conditions being subject only
to judicial review. This commenter added that the 2019 proposed rule was a sharp departure from the 50
years of EPA's interpretation and practice, asserting that the 1971 Rule did not inteiject Federal oversight

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into states' processes. The commenter further said that the 2019 proposed rule would impose Federal
agency control and upend cooperative federalism.

Agency's Response: See the Agency's Response to Comments in Sections 7.1-7.6; see also
Section IV.G of the final rule preamble.

In response to commenter assertions regarding relying on the "lead" Federal agency for
carrying out section 401 responsibilities, the Agency wishes to clarify the applicability of
section 401. For any given project, section 401 certification is required for any activity
subject to at least one Federal license or permit that may result in any discharge into waters
of the United States. A certifying authority may opt to provide one certification of the
activity that specifically covers multiple Federal licenses or permits, but that does not
obviate the need for a project proponent to request certification for each Federal license or
permit. Depending on the requirements of the applicable certifying authority, a project
proponent may be able to submit multiple requests for certification in a single document
covering multiple Federal licenses or permits. The only circumstance in which a project
proponent may not need to request a separate certification for different Federal licenses or
permits for the same activity is in accordance with section 401(a)(3). Under section
401(a)(3), a project proponent may rely on the same certification obtained for the
construction of a facility for any Federal operating license or permit for the facility if 1) the
Federal agency issuing the operating license or permit notifies the certifying authority, and
2) the certifying authority does not within 60 days thereafter notify the Federal agency that
"there is no longer reasonable assurance that there will be compliance with applicable
provisions of sections [301, 302, 303, 306 and 307 of the CWA]." 33 U.S.C. 1341(a)(3).
Accordingly, a project proponent may not be able to rely on the same certification for each
and every Federal license or permit for the same activity.

7.7.2 Pre-proposal Input from 2021

This sub-topic summarizes input that was received prior to the 2022 proposed rule and was resubmitted
by commenters in the docket for the 2022 proposed rule.

A stakeholder stated that Federal agencies have the authority to evaluate certification actions and asserted
that the statute requires the Federal agency to make a threshold determination on whether the certification
has been issued, denied, or waived.

A different stakeholder said that requiring Federal agencies to waive on "refusal to satisfy the
requirements" of certain provisions polices certifying authorities' compliance with EPA's procedures in a
way that is less costly in terms of time and money than judicial review. Another stakeholder said the 2020
Rule altered the review of 401 decisions from judiciary to the Federal executive branch.

One stakeholder recommended that EPA remove the 2020 Rule provisions providing Federal agencies'
review of state's decisions for compliance with procedural requirements and said that there is no section
401 text or legislative history authorizing this review. This stakeholder also stated that EPA should clarify

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that the review of certification requests should comply with state procedural requirements and that EPA
encourage other Federal agencies to conform their section 401 procedures to the new rule to promote
consistency. The stakeholder added that EPA should eliminate any Federal review of the substance or
contents of certifications and further called for the repeal of the 2020 Rule's Federal agency review
requirement in its entirety.

A few stakeholders expressed concern that the 2020 Rule's Federal agency review requirements give
Federal agencies the authority to veto state and Tribal conditions by deeming certification authority
waived if the Federal agency determines that the state or Tribe did not follow procedural elements of the
rule, contravening the CWA.

A stakeholder stated that the 2020 Rule should be revised to eliminate citation requirements to specific
water quality requirements and providing rationale for each water quality condition. The stakeholder
added that procedural requirements should not be the basis for a Federal agency's determination of waiver
or to eliminate conditions.

Agency's Response: See the Agency's Response to Comments in Sections 7.1-7.6; see also
Section IV.G of the final rule preamble.

8. EPA's Roles Under Section 401 (Sections 121.16-121.18)

8.1 EPA as a Certifying Authority

One commenter recommended finalizing the proposed provisions related to when EPA acts as a certifying
authority and asserted that the statutory language related to when EPA should act as a certifying authority
is adequately clear. Conversely, another commenter stated that EPA had not identified why establishing
procedures is necessary for EPA to carry out its roles.

A few commenters expressed explicit support for the proposed updates to the public notice and hearing
provisions when EPA acts as the certifying authority. Another commenter said that a procedure for
requesting technical assistance would be helpful.

A few commenters discussed the 2020 Rule provisions that defined how the Agency could request
additional information when it acts as the certifying authority (located at section 121.14 of the 2020
Rule). A couple of commenters agreed that EPA should not be limited on the amount of information it
can request from a project proponent to meet its 401 obligations. One of these commenters asserted that
section 121.14 of the 2020 Rule is unnecessary because proposed section 121.7(b) will ensure that EPA
will act on requests for certification within the scope of certification within a timely manner. Conversely,
another commenter recommended retaining section 121.14(b) from the 2020 Rule and modifying section
121.14(a) from the 2020 Rule to require EPA to make all requests for additional information no later than
120 days before the end of the reasonable period of time unless a change of circumstance under section
401(a)(3) occurs.

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One commenter stated that EPA needs to acknowledge in regulations its Federal trust responsibility and
to codify its Tribal consultation process. Likewise, a commenter recommended that EPA should add
language to proposed section 121.16(b) to require EPA to comply with the Agency's Tribal consultation
and coordination policies and applicable Tribal treaty provisions to assure Tribes that EPA will
consistently comply with these requirements. The commenter also recommended adding a new section
121.19 to limit revisions to part 121 unless EPA acts in compliance with applicable Tribal consultation
and coordination policies and applicable Tribal treaty provisions, asserting that EPA failed to comply
with consultation obligations on the 2020 Rule and that obtaining the free, prior, and informed consent of
Indigenous Peoples should be a requirement for agency decisions that would impact their resources.

A few commenters discussed environmental justice as it relates to EPA's role as a certifying authority.
One commenter expressed optimism about the incorporation of environmental justice in the EPA's roles
under section 401. Another commenter recommended that EPA codify its environmental justice
commitments at proposed section 121.16 including requiring EPA to consider whether the activity as a
whole has disproportionately high and adverse human health or environmental effects on members of
Tribes, minority populations, and low-income populations; consider the cumulative impacts to human
health, resources used for subsistence, cultural resources and uses, and treaty-protected resources;
consider the historical injustices (such as damming, diversion, or reduction in flow of a waterbody) and
how those actions have impacted the resources and human population; consider whether the applicant's
activity as a whole will have long term impacts on any watersheds; and publish a written environmental
justice analysis in a public docket prior to the issuance of a certification decision.

A commenter said that EPA rarely uses its role as a certifying authority for non-TAS Tribes and on lands
exclusively under Federal jurisdiction, and the commenter said EPA needs to investigate this and take
action to ensure EPA fulfills this role appropriately.

Agency's Response: EPA is finalizing revisions to the part 121 regulations to provide
greater clarity about EPA's process when it acts as the certifying authority. Including
provisions specific to EPA's role as the certifying authority is consistent with the Agency's
longstanding approach. See 40 CFR 121.13-15 (2020) (defining procedures when EPA acts
as the certifying authority) and 40 CFR 121.21-28 (2019) (same). Additionally, the final rule
includes provisions, such as those addressing contents of requests for certification and
certification decisions, to provide transparency in the certification process for all reviews,
including those conducted by the EPA when it acts as the certifying authority.

EPA agrees with some of these commenters and finds that the provisions at sections 121.16
and 121.17 will provide stakeholders with greater certainty and predictability around the
section 401 certification process where EPA acts as the certifying authority.

The final rule clarifies that EPA must provide technical advice if requested by a Federal
agency, certifying authority, or project proponent on (1) applicable effluent limitations, or
other limitations, standards (including water quality standards such as water quality
criteria), regulations, or requirements, and (2) any methods to comply with such limitations,
standards, regulations, or requirements. See 40 CFR 121.18. Federal agencies, certifying

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authorities, and project proponents may request EPA's technical assistance at any point in
the certification process. The Agency did not expand on the procedures for requesting
technical advice to leave flexibility for the ways that Federal agencies, certifying authorities,
project proponents may request for technical advice.

Consistent with the proposal, EPA is removing section 121.14 of the 2020 Rule in its entirety
because it finds these provisions not conducive to an efficient certification process for
several reasons discussed in Section IV.H of the final rule preamble. The Agency agrees
with the commenter that regulatory requirements in the final rule (e.g., section 121.7(b)) are
sufficient to ensure the Agency will act on requests for certification in a timely and
appropriate manner.

The Agency appreciates commenter input on tribal consultation in the section 401 process.
Although the Agency is declining to add regulatory text regarding the Agency's Tribal
consultation policies, EPA emphasis that when it certifies on behalf of Tribes without TAS,
its actions as a certifying authority are informed by its Tribal policies and the Federal trust
responsibility to federally recognized Tribes. EPA's 1984 Indian Policy, recently reaffirmed
by EPA Administrator Regan, recognizes the importance of coordinating and working with
Tribes when EPA makes decisions and manages environmental programs that affect Indian
country. See EPA Policy for the Administration of Environmental Programs on Indian
Reservations (November 8,1984), available at https://www.epa.gov/sites/default/files/2015-
04/documents/indian-policy-84.pdf; see also Memorandum from Michael S. Regan to All
EPA Employees, Reaffirmation of the U.S. Environmental Protection Agency's Indian
Policy (September 30, 2021), available at https://www.epa.gov/system/files/documents/2021-
09/oita-21-000-6427.pdf. This includes coordinating and working with Tribes on whose
behalf EPA reviews and acts upon requests for certification on federally licensed or
permitted projects.

Regarding the environmental justice comments above, EPA finds that the final rule allows
for outreach designed to reach all potentially interested stakeholders, including
communities with environmental justice concerns, which is consistent with the Federal
government's commitment to empower communities, protect public health and the
environment, and advance environmental justice in Executive Orders 14096,14008,13990,
and 12898. The Agency discusses in section IV.H of the final rule preamble that when EPA
acts as the certifying authority, it will consider impacts on communities with environmental
justice concerns who disproportionately bear the burdens of environmental pollution and
hazards, including Tribal Nations. EPA emphasizes that in considering impacts from a
federally license or permitted project, water quality-related impacts on communities with
environmental justice concerns are issues that fall within the relevant scope of analysis and
should inform decision-making on requests for certification. Broadening the public notice
provision in the final rule also provides communities seeking to advance environmental
justice with greater opportunities to inform the certification process. The Agency is not
including specific regulatory text on incorporating environmental justice into the

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certification process to provide the Agency with the flexibility to determine methods to
incorporate environmental justice in the section 401 certification process.

The Agency recognizes the importance of its role as the certifying authority in instances
where a state or Tribe does not have authority to issue certifications. The Agency has made
revisions throughout this final rule to clarify and help in the implementation of EPA's roles
under section 401, including its role as the certifying authority. These revisions should help
ensure EPA can fulfill this role appropriately.

8.2 Lands of Exclusive Federal Jurisdiction

Some commenters addressing lands subject to exclusive Federal jurisdiction expressed concern that EPA
would act as the certifying authority for all national parks under the proposal. These commenters stated
that section 401 does not grant EPA authority to act as a certifying authority for national parks, and
further asserted that EPA acting as a certifying authority for national parks would be inconsistent with the
history of other authorities issuing certifications for national park lands and the exclusive grant of
authority to states and Tribes in section 401. These commenters also reported that this approach regarding
national parks would create confusion and inefficiency.

Another commenter more broadly argued that section 401 does not authorize EPA to issue certifications
for lands subject to exclusive Federal jurisdiction and that it would be contrary to the statutory language
and intent for EPA to act as a certifying authority over such lands. This commenter asserted that this
approach would remove authority from states to protect water quality under section 401 in large areas
within their borders. More specifically, the commenter acknowledged that Yellowstone National Park is
subject to exclusive Federal jurisdiction but requested that EPA recognize Wyoming as the appropriate
certifying authority over this area.

With regard to identifying lands subject to exclusive Federal jurisdiction, a commenter supported the
approach taken in the proposal to not provide an exclusive list of such areas, but recommended the
development of guidance to identify areas where EPA acts as a certifying authority to assist stakeholders
and ensure effective participation in proceedings in these circumstances. Conversely, another commenter
stated they support the development of a list of lands subject to exclusive Federal jurisdiction, because
many Tribes have treaty-protected rights to waters that flow through exclusive jurisdiction lands.

Agency's Response: As an initial matter, EPA wishes to emphasize that not all Federal
lands or national parks are lands of exclusive Federal jurisdiction. Rather, exclusive
Federal jurisdiction is established only under limited circumstances pursuant to the Enclave
Clause of the U.S. Constitution, article 1, section 8, clause 17. These circumstances include
(1) where the Federal government purchases land with state consent to jurisdiction,
consistent with article 1, section 8, clause 17 of the U.S. Constitution; (2) where a state
chooses to cede jurisdiction to the Federal government; and (3) where the Federal
government reserved jurisdiction upon granting statehood. See Paul v. United States, 371
U.S. 245, 263-65 (1963); Collins v. YosemitePark Co., 304 U.S. 518, 529-30 (1938); James v.
Dravo Contracting Co., 302 U.S. 134,141-42 (1937); Surplus Trading Company v. Cook, 281

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U.S. 647, 650-52 (1930); Fort Leavenworth Railroad Company v. Lowe, 114 U.S. 525, 527
(1895).

EPA disagrees with the commenter asserting that section 401 does not authorize EPA to
issue certifications for lands subject to exclusive Federal jurisdiction in relevant respects
and that it would be contrary to the statutory language and intent for EPA to act as a
certifying authority over such lands. Section 401(a)(1) specifically anticipates circumstances
in which no state or interstate agency has authority to provide certification, directing that
"[i]n any such case where a State or interstate agency has no authority to give such a
certification, such certification shall be from the Administrator." 33 U.S.C. 1341(a)(1)
(emphasis added). Lands of exclusive Federal jurisdiction in relevant respects present a case
where states lack authority for certification pursuant to section 401, as states lack legislative
jurisdiction in these areas absent specific congressional action. See Paul, 371 U.S. at 263
(finding precedent establishes "that the grant of 'exclusive' legislative power to Congress
over enclaves that meet the requirements of Art. I, s 8, cl. 17, by its own weight, bars state
regulation without specific congressional action."). In section 401, Congress did not take
specific action to grant authority to states to issue certification over lands of exclusive
jurisdiction in relevant respects. On the contrary, Congress provided in section 401(a)(1)
that the EPA Administrator shall issue certification "in any such case" where no state or
interstate agency has authority to give certification, and otherwise recognized the
Administrator as a certifying authority. In addition to the statutory text, the legislative
history further supports that Congress did not grant authority to states to issue certification
where states otherwise lack authority, such as lands of exclusive Federal jurisdiction in
relevant respects. See 116 Cong. Rep. 9316, 9328 (March 25,1970) (statement of Rep.
Harsha) (emphasis added) ("Another area of great complexity is that covered by section
21—certification by the States to Federal agencies in cases where application has been made
for Federal licenses or permits. That certification must come from the States unless, of
course, the waters involved are under the direct supervision of the Federal Government or
there is no State certifying authority.'1'1). As a result, EPA finds that section 401 directs the
Administrator to issue certification in lands of exclusive Federal jurisdiction in relevant
respects. The Agency further disagrees that the Administrator issuing certification for lands
of exclusive Federal jurisdiction in relevant respects removes authority from states, as states
under section 401 and the U.S. Constitution do not have a jurisdictional basis providing
authority to issue certification for lands of exclusive Federal jurisdiction in relevant
respects.

Because such jurisdictional status is subject to change, EPA is not providing an exclusive
list of lands subject to exclusive Federal jurisdiction. However, EPA is able to offer
technical assistance to stakeholders if questions arise regarding the appropriate certifying
authority on a given federally licensed or permitted project. See also Section IV.H of the
final rule preamble for further discussion on exclusive Federal jurisdiction, including a list
of national parks that include lands of excusive Federal jurisdiction.

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8.3 Input Received on Prior Rulemakings

8.3.1 Input on the 2019 Proposed Rule

This sub-topic summarizes comments that were made on a previous proposed rulemaking and were
resubmitted by commenters in the docket for the 2022 proposed rule.

One commenter stated that when EPA is acting as the certifying authority, the "public notice"
requirement should be expanded to include the general public, in addition to those listed parties known to
be interested to remain consistent with other Federal public notice practices.

One commenter expressed support for the interpretation of EPA's authority for the Administrator to
certify compliance with water quality standards when no state, Tribe, or other agency has the authority to
give such a certification and stated that the 2019 proposed rule procedural requirements were an effective
regulatory backstop.

Agency's Response: See the Agency's Response to Comments in Sections 8.1-8.2; see also
Section IV.H of the final rule preamble.

EPA is finalizing section 121.17 as proposed, with minor, non-substantive revisions, to
facilitate participation by the broadest number of potentially interested stakeholders, which
could include but is not limited to the general public and parties known to be interested.

9. Modifications (Section 121.10)

9.1 General Legal Comments on Modification

Some commenters disagreed with the inclusion of a modification provision because the statute does not
include a reference to "modifications." A few commenters warned EPA that it is a trap to interpret the
absence of a statutory modification provision as the authority to create a modification procedure. One
commenter described this interpretation as a reversal of the fundamental axiom of statutory interpretation
that agencies only have the powers delegated to them by Congress. Another commenter asserted that
Congress included only two narrow and time-limited mechanisms in the statute for amending or
rescinding certifications - sections 401(a)(3) and 401(a)(4). The commenter concluded that there is
simply no reason "to believe that Congress, by any remaining ambiguity, intended to undertake the
regulation" of a subject "never mentioned in the statute," such as an additional authorization for certifying
authorities to modify certifications for any reason or any timeframe. Am. Bar Ass 'n v. FTC, 430 F.3d 457,
469 (D C. Cir. 2005).

A few commenters noted that the modification provision in the proposed rule represents a return to the
flexibility of the longstanding 1971 Rule. One commenter stated that the proposed rule appropriately
reintroduced the modification process. Another commenter asserted that the proposed rule's modification
procedures were balanced and would ensure that any significant changes found after the certification and
permit are issued can be addressed.

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A few commenters recommended finalizing a modifications provision similar to the one proposed
because case law supports allowing modifications to conditions (See, e.g., Snoqualmie Indian Tribe v.
FERC, 545 F.3d 1207, 1219 (9th Cir. 2008); Airport Communities Coal. v. Graves, 280 F. Supp. 2d 1207,
1214-17 (W.D. Wash. 2003)).

Agency's Response: The Agency recognizes that CWA section 401 does not expressly
authorize or prohibit modifications of certifications. However, EPA concludes that the best
interpretation of section 401 is one that allows for modifications with reasonable guardrails
like the ones in this final rule. This interpretation is supported by the text of section 401,
which envisions the certifying authority participating in the Federal licensing or permitting
process after the issuance of a certification, see 33 U.S.C. 1341(a)(3)-(4), as well as
Congressional intent and relevant case law. See Section IV.I of the final rule preamble for
further discussion on the Agency's rationale for finalizing a modification provision.

9.1.1 State Law/Judicial Process

Some commenters argued that EPA must change the proposed modification provision because state
regulations and administrative procedures clearly outline and allow for revocation, stays, remands and
vacaturs of certification decisions. See, e.g., 15AN.C. Admin. Code 2H.0507(d); Or. Admin. R. 340-048-
0050. A few commenters asserted that the state regulatory processes for modification or revocation of
state water quality certification should not be supplanted by EPA's regulation. One commenter argued
that limits to a state or Tribe's ability to modify or revoke certification decisions in accordance with their
state or Tribal laws exceeds EPA's rulemaking authority. Another commenter recommended deleting
section 121.10(a) because the provision interferes with state or Tribal laws that allow a certifying
authority to reconsider and change the nature of their decisions. One commenter suggested amending
proposed section 121.10(b) to allow the certifying authority to modify a certification in accordance with
applicable state or Tribal law. One commenter suggested that EPA take no position on the ability of states
and Tribes to revoke or modify their decisions because state and Tribal regulations may provide for the
ability to revoke or modify their decisions.

A few commenters suggested that a certification modification would be necessary if a certification
decision is subsequently stayed, remanded, or vacated by a court or appropriate state administrative
review board, thereby necessitating reconsideration by the certifying authority. One commenter
recommended that EPA should clarify that it did not intend to suggest that stayed certifications may be
modified in the absence of a court order addressing the merits of the challenged requirement. Another
commenter argued that EPA should acknowledge that certifications or waivers may be modified or
revoked as required by judicial review, otherwise the regulation would be inconsistent with the respect for
state law and institutions embodied in section 401. One commenter expressed that a prohibition on
changing the nature of the decision could prevent meaningful administrative or judicial review of initial
denials of certification. Another commenter asserted that placing constraints on a state or Tribe's ability
to revoke or modify a certification decision, particularly if directed to do so by a state or Tribal tribunal
on remand following appeal, would interfere with the operation of state or Tribal law that governs the
substance of certification. See American Rivers, 129 F.3d at 102. One commenter asserted that

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administrative or judicial review provide procedural protections for project proponents and community
stakeholders, and it is an important element of a cooperative federalism system. The commenter argued
that where there are reservations of authority under state regulations for administrative or judicial review,
agreement from the Federal agency or the project proponent should be unnecessary. Furthermore, the
commenter recommended that EPA remove the limitations for a grant of certification to become a denial
of certification and vice versa because administrative or judicial decisions may warrant such a change in
the nature of the original certification decision.

Some commenters stated that certifying authorities should be able to modify their certification decisions
in light of changes in state or Tribal water quality requirements, such as upgraded water quality standards.
One commenter recommended that EPA clarify that reservations of authority are permissible to allow
certification modification for water quality protection when revisions to water quality standards occur.
The commenter noted that the proposed rule preamble acknowledges, in issuing a certification, a
certifying authority is stating that the activity as a whole will comply with water quality requirements for
the life of the license or permit, not just at the time of issuance. Conversely, a few commenters disagreed
that certification modifications should be allowed for changes in state or Tribal law because state law can
change frequently and projects should rely on the law in place at the time the Federal license or permit is
issued.

Another commenter asserted that the proposed modification provision would unnecessarily increase the
burden on certifying authorities where their regulations already allow for modifications to certification
decisions. Another commenter highlighted the fact that in some cases, a certifying authority's procedures
may allow a modification with minimal review and no public notice, while in some cases a modification
request may be treated as new and subject to the certifying authority's public notice requirements.

Agency's Response: In response to comments regarding revoking or reversing certification
decisions, the Agency recognizes the ongoing need to adapt to new and changing
information after a certification decision has been issued, but the Agency is declining to
broaden the final rule's modification provision to be a mechanism to revoke or reverse a
certification decision. As discussed in section IV.I of the final rule preamble, while the
statutory language and legislative history appear to countenance a role for certifying
authorities after a certification is issued, EPA concludes that this role does not include
unilateral action to revoke or reverse the decision. In response to commenters, EPA is
clarifying that this statement—and more broadly section 121.10 of this final rule—are not
meant to address certifying authority action on a request for certification upon remand
from a court or administrative tribunal of the certifying authority's initial action on the
request. Section 121.10 is also not intended to address or govern court vacatur of
certification decisions, or action by a certifying authority after a court vacatur (although the
Agency notes that it is unclear how a vacated certification decision could be "modified").
This final rule does not address the situations of vacatur or remand by a court or
administrative tribunal. See also the Agency's Response to Comments in Section 9.3.3.
Furthermore, this final rule's modification provision is not meant to address a certifying
authority's action on a state or Tribally- issued license or permit, which sometimes

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concurrently acts as the state or Tribe's section 401 certification decision. Such matters are
outside the scope of this rulemaking.

The Agency appreciates commenter input regarding scenarios that may benefit from a
modification provision. After reviewing public comment, EPA is not finalizing a list of
scenarios that may warrant certification modification because the certifying authority and
Federal agency are in the best position to work together to determine whether a new
certification or a certification modification is appropriate in a given situation. See Section
IV.I of the final rule preamble for further discussion on the Agency's rationale for not
finalizing a list of scenarios that may require modification.

The Agency disagrees that the modification provision would unnecessarily increase the
burden on certifying authorities where their regulations already allow for modifications to
certification decisions. Prior to the 2020 Rule, the Agency's longstanding 1971 Rule allowed
certification modifications to occur after a certification was issued, provided the certifying
authority, Federal agency, and the EPA Regional Administrator agreed to the modification.
40 CFR 121.2(b) (2019). Similar to the 1971 Rule, the final rule's modification provision
relies on an agreement between the certifying authority and Federal agency. However, the
final rule does not include a role for EPA in the certification modification process where the
Agency is neither the certifying authority nor the Federal licensing or permitting agency.
This should simplify any negotiations or agreements and make the modification process less
burdensome. Additionally, the Agency notes that the final rule provision at 40 CFR 121.10
also does not preclude Federal agencies from developing a process for coordinating with
certifying authorities on certification modifications within the framework provided in this
final rule.

In response to the comment regarding certifying authority procedures for modifications, the
Agency recognizes that some certifying authorities may be required under their regulations
to make any proposed modifications to their certification decisions available for public
notice and comment. This final rule does not preclude certifying authorities from following
their own modification procedures for certifications on Federal licenses or permits,
consistent with this final rule.

9.2 Impact of Modifications

9.2.1 Administrative Burden

Some commenters expressed support for the proposed modification process, calling it a significant
improvement over the 2020 Rule because the proposed process will reduce administrative burdens on
project proponents and certifying authorities. One of these commenters also asserted that modifications
would allow the project proponent to avoid completing procedural requirements more than once and
ensure a cooperative relationship between the project proponent and certifying authority.

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However, one commenter asserted that the limits of the proposed rule may burden the project proponent
with the requirement to obtain a new certification if the Federal agency disagrees with a project
proponent's request to a certifying authority to modify the scope and conditions of its water quality
certification.

Agency's Response: EPA agrees that the modification provision in the final rule will reduce
administrative burdens. The modification provision of the final rule will restore flexibility
and efficiency where certifying authorities and Federal agencies find it appropriate to
update a previously issued grant of certification rather than restart the section 401
certification process in response to changed circumstances or new information. However,
EPA does not expect the modification provision to address every issue that may arise after a
certification has been granted.

In response to commenter concerns regarding project proponent burden where the Federal
agency disagrees with a proposed modification, EPA expects that Federal agencies will not
unreasonably withhold agreement to a modification. However, beyond modifications to
existing certifications, there may be circumstances that warrant the submission of a new
request for certification, such as if certain elements of the activity (e.g., the location or size
of the activity) change materially in a manner that could impact water quality after a
project proponent submits a request for certification. If the activity changes so materially
after the request for certification as to constitute a different activity, this may warrant a
new request for certification. See Section IV.I of the final rule preamble for further
discussion.

9.2.2 Environmental Benefits, Long Term Projects, and Unanticipated Impacts

Commenters asserted that the ability to modify conditions is vital to certifying authorities' ability to
protect their water quality, and that they should have the ability to re-visit conditions to ensure that they
are protecting water quality as conditions change as a result of climate change and other factors. Some
commenters suggested that modifications are critical to addressing changing facts on the ground, such as
listing of a new species affected by the project as threatened or endangered, and the impacts from climate
change, including sea-level rise, increasing intensity of storms, floods, and droughts, and changes to the
hydrology of the affected water resource.

A few commenters described the need for a "common sense" modification provision that ensures
protection of water quality and continued compliance with water quality certifications. One commenter
argued that a process for certification modifications provides an off-ramp to monitoring conditions for
project proponents because the project proponent can use adaptive management and reporting to meet
water quality requirements only as long as the information is necessary. A few other commenters argued
that certifying authorities are unable to anticipate all effects from a discharge on water resources and new
information regularly becomes available after certification was granted, denied, or waived. One
commenter asserted that modifications are important for taking action to protect water quality from harms
that were unknown or unforeseen when the certification was originally issued. One commenter also noted

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that modifications would allow for incorporation of emerging, new technology developed after a
certification is issued.

A few commenters highlighted the need for certification modifications, especially for projects with longer
lifespans (such as large pipelines and hydropower projects with FERC licenses for 30-50 years). These
commenters argued that there should not be a limit on the period when certification modifications can be
addressed because some projects are ongoing for a long time, during which time water quality concerns
may arise. One commenter noted that FERC licenses hydropower dams for 30-50 years and asserted that
environmental conditions will inevitably change during the license term. The commenter asserted that
modifications may be warranted based on the availability of new information that was not available at the
time of certification or changed circumstances, such as climate change, extreme hydrologic events,
cumulative impacts from other projects, flow diversions, the listing of species under the Endangered
Species Act, changes in existing uses including recreation, and project impacts on aquatic or terrestrial
impact over time. Another commenter asserted that reopener conditions are important to address
significant, ongoing impacts from non-Federal dams, impacts which climate change is predicted to
compound over the term of a FERC license.

One commenter argued that without a mechanism for certification modifications, which can be used as an
adaptive management approach towards compliance, certifying authorities may have to wait several years
or decades to compel compliance with water quality requirements. Another commenter gave an example
of a project that received a waiver of certification in 1982; without the ability to reopen or modify the
waiver, the commenter asserted that the certifying authority would continue to not be able to review the
project for water quality impacts over the course of 60 years, during which time, science and technology
would change.

A few commenters noted that modifications to certifications allows for flexibility to adapt to dynamic
situations, such as larger, phased projects with multi-decade timeframes. A few commenters
acknowledged that reopener conditions or reservations of authority were used historically to certify
projects that are multi-year or phased because the full scope of project information may not be available
during the first few years or first phase of a project.

Agency's Response: After considering public comment, the Agency is promulgating a final
rule at section 121.10 that provides the opportunity for certification modification at any
point after certification issuance (until the expiration of the Federal license or permit),
provided the Federal agency and the certifying authority agree in writing prior to
modifying the grant of certification. As commenters noted, changes to an activity that have
significant implications for water quality can occur at any point in time after a certification
is granted. Accordingly, the Agency finds this approach best reflects the reality that
projects change over time, and provides flexibility for project proponents, certifying
authorities, and Federal agencies to adapt to changing circumstances without needing to
reinitiate the certification process.

Importantly, the final rule provision for modifications to a grant of certification balances
the certifying authorities' need for flexibility to protect water quality and the potential

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reliance interests of project proponents and Federal agencies once the certifying authority
has issued a grant of certification. Accordingly, EPA intends that a modification to a grant
of certification means a change to an element or portion of a certification or its conditions—
it does not mean a wholesale change in the type of certification decision or a reconsideration
of the decision whether to certify (e.g., changing a grant of certification to a denial of
certification). While the final rule text does not address modifications to denials or waivers
for the reasons discussed in Section IV.I of the final rule preamble, EPA nonetheless
concludes for the reasons mentioned in the final rule preamble that section 401 does not
authorize a certifying authority to "modify" a denial or waiver into a fundamentally
different decision such as a grant of certification.

Ultimately, certifying authorities and Federal agencies are encouraged to work together to
address new information or changed water quality conditions throughout the life of the
project such that Congressional intent behind section 401—enabling states to protect their
water quality—can be preserved.

9.2.3 Reliance Interest

A few commenters argued that the proposed modification provision may reduce project proponent
reliance interests if a certification can be changed after the reasonable period of time. One commenter
asserted that reducing the ability to rely on a water quality certification will cool investment in projects
that require section 401 certification, and suggested EPA remove the modification provision in the final
rule. One commenter suggested that it may be physically or practically impossible to change a major
infrastructure project if major changes to a certification occur after the construction of the project is
complete, therefore the commenter recommended that EPA finalize a provision limiting major
modifications. Another commenter opposed any modification provision, even in the "reasonable period of
time," asserting that modifications are unjust and unreasonable and create uncertainty that would
undermine project proponent's reliance interest.

One commenter stated that an expansive modification process could generate severe issues for
construction and operation planning and could risk legal disputes as to finality and reliance.

One commenter asserted that the definition in the proposal preamble of a "modification" as a "change to
an element or portion of a certification or its conditions" is too broad and would afford certifying
authorities with the ability to impose a de facto denial through onerous changes well after the project
proponent acted in reasonable reliance on the initial certification.

Agency's Response: The Agency disagrees with commenter assertions that a modification
provision such as the one in this final rule would significantly impact project proponent
reliance interests. EPA is finalizing a provision for modifications to a grant of certification
that balances the certifying authorities' need for flexibility to protect water quality and the
potential reliance interests of project proponents and Federal agencies once the certifying
authority has issued a grant of certification. See the Agency's Response to Comments in

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Section 9.2.2 and Section IV.I of the final rule preamble for further discussion on limits to
modifications of certification decisions.

The Agency also disagrees with commenters asserting that a modification provision would
"cool investment" or generate issues in construction and operation planning. In fact,
relative to the 2020 Rule, the Agency expects the reintroduction of a certification
modification provision to reduce burden on project proponents by adding the flexibility
they need to adapt to changing circumstances or new information, without limiting them to
submission of a new request for certification when the Federal agency has not established
other modification mechanisms.

The Agency emphasizes that this final rule encourages certifying authorities, project
proponents, and Federal agencies to communicate early and often in the certification
process (e.g., pre-filing meeting provision) to ensure parties develop a common
understanding regarding the proposed project. Such communication may reduce the need
for certification modifications. In the event a modification occurs, the Agency recommends
that certifying authorities engage with the stakeholders who will be impacted by a
modification to the certification; some certifying authorities may even be required under
their regulations to make any proposed modifications to their certification decisions
available for public notice and comment. Although section 121.10 as finalized does not
provide the project proponent with a formal role in the modification process, it also does
not prevent engagement with the project proponent before or after the certifying authority
and Federal agency have agreed that the certifying authority may modify the previously
granted certification.

9.3 Types of Modifications

9.3.1 Fundamental Changes in Certification Decisions

Commenters provided differing views on whether EPA should limit the nature of a modification to a
certification decision. Some commenters supported the proposed rule's approach to limiting the
circumstances in which a certifying authority may modify their certification decision after the reasonable
period of time while still providing flexibility to adapt to new information. A few commenters explicitly
agreed with EPA that modifications may not fundamentally change the certification action.

Conversely, a couple of commenters disagreed with the proposed rule's approach to changing
certification decisions through modifications. One commenter disagreed that a modification should never
result in a change in decision (e.g., changing a grant to a denial) and asserted that it is necessary where the
discharges are substantially more severe than proposed; new information is obtained which contradicts
the rationale for the certification decision; violations of related state regulations; submittal of fraudulent
information; or failure to comply with conditions which are essential for compliance with water quality
standards.

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One commenter specifically discussed denials and recommended that the final rule should omit the
proposed prohibition on revoking or modifying a denial of certification or limit its application to
circumstances in which the Federal agency has denied the license or permit application based on the
denial of certification. The commenter asserted that no such prohibition is required by or can be inferred
from section 401. The commenter asserted that the proposal's justifications of "reliance interests and
regulatory certainty" do not apply if the Federal agency has not yet denied the license or permit
application based on the denial of the request for certification. The commenter further asserted that the
proposed prohibition could prevent meaningful administrative or judicial review of a certifying
authority's initial denial of certification. The commenter asked, if the applicant were to litigate
successfully to invalidate the denial, does the proposed rule mean that the court decision somehow does
not "count"? The commenter asserted that this would seem to present a serious due process problem.

A few commenters explained that the only circumstance in which converting a certification into a waiver
might create detrimental reliance is that in which the Federal agency has issued the license or permit with
the conditions of the certification; however, the Federal agency may be able to modify their license or
permit to remove the waived conditions. Accordingly, one of these commenters recommended that the
final rule should omit the prohibition on waiving certification after an initial decision to grant (with or
without conditions).

Agency's Response: As discussed in Section IV.I of the final rule preamble, EPA intends
that a modification to a grant of certification means a change to an element or portion of a
certification or its conditions—it does not mean a wholesale change in the type of
certification decision or a reconsideration of the decision whether to certify (e.g., changing a
grant of certification to a denial of certification). Section 121.10(b) of the final rule makes
this clear by providing that a certifying authority may not—through the final rule's
modification provision—revoke a grant of certification or change it into a denial or waiver.
Constraining certifying authorities from fundamentally changing their certification action
through a modification process recognizes reliance interests and promotes regulatory
certainty. Further, EPA has concerns that changing the fundamental nature of the
certification action (e.g., change a grant, denial, or waiver to something entirely different)
may be inconsistent with the Congressional admonition to act on a certification request
within the statutory reasonable period of time. See Section IV.I of the final rule preamble
for further discussion on the Agency's rationale; see also the Agency's Response to
Comments in Section 9.2.2 and 9.2.3.

In response to the commenters recommending that the final rule should omit the proposed
prohibition on revoking or modifying a denial of certification or converting a grant of
certification into a waiver, the Agency notes that the final rule does not address these
situations and addresses only modifications to a grant of certification. Commenters
indicated much greater interest regarding modification to grants of certification, and very
little interest regarding modifications to a denial or waiver. Commenters also expressed
confusion regarding EPA's proposed language regarding modifications to a denial or
waiver.

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9.3.2 Scope of Modification

Some commenters suggested that modifications should be limited in scope. Some commenters
recommended that modifications should be limited to non-substantive issues, such as a change to correct a
typographical error, fixing scrivener's errors, extending certain dates, or a change to the point of contact
for the project and, according to a few commenters, not a tool for reconsidering or reopening an already
approved certification. Similarly, another commenter recommended retaining a certification modification
process where the project changes but does not necessitate a change to the underlying Federal license or
permit.

Conversely, other commenters recommended that EPA explicitly allow for modifications when
significant changes occur. A few commenters noted that certification modifications may be appropriate or
warranted to address material changes to the certified project itself (e.g., change in project design for
construction/operation/maintenance/mitigation, the nature of the licensed or permitted discharge may
change, or the discharge location may change). One commenter suggested that EPA explicitly allow
modifications of certifications where new information or project changes of a substantive nature arise,
particularly where such information or changes also require a modification or amendment of a
corresponding Federal approval. Another commenter expressed support for a collaborative modification
process but requested that EPA add language to specify that modifications should only be requested when
a significant change occurs. The commenter suggested using section 401(a)(3) as a model for such
language.

Agency's Response: As an initial matter, EPA wishes to emphasize that the same scope of
section 401 that applies to a certification decision also applies to any subsequent
modification to a grant of certification. See 40 CFR 121.3(b). After reviewing public
comment, EPA is not finalizing a list of scenarios that may warrant certification
modification because the certifying authority and Federal agency are in the best position to
work together to determine whether a new certification or a certification modification is
appropriate in a given situation. Although EPA understands the perspective of most
commenters that it may be helpful to have examples of circumstances where a modification
to a certification may be appropriate, EPA is declining to include a non-exhaustive list in
the regulatory text so that certifying authorities and Federal agencies retain the flexibility to
determine their certification modification needs after considering the local water quality
and project-specific context. Even without a list in the regulation, EPA still expects that the
Federal agency will not unreasonably withhold its agreement to modifications, especially for
administrative edits, such as correcting typographical errors, changing a point of contact,
or adjusting a certification's expiration date to reflect an updated license or permit
expiration date. See Section IV.I of the final rule preamble for further discussion, including
limits to modification of certification decisions.

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9.3.3 Unilateral Modifications, Reopener Conditions, and the Ability to Revoke
Certifications

Some commenters argued that certifying authorities should be allowed to unilaterally modify, revoke, or
"reopen" certifications for good cause, including unforeseen water quality impacts, changed
environmental conditions, especially those related to climate change, and any other new information.

One commenter, citing to CWA section 501(a), asserted that a prohibition on unilateral modifications is
not found in the statute and runs counter to the regulatory scheme Congress established in section 401.
The commenter asserted that if EPA wishes to obtain concurrence from the Federal permitting agency
when EPA is acting as the certifying authority, it is free to do so and write regulations to that effect.

Several commenters discussed unilateral modifications in certain circumstances. A few commenters
asserted that certifying authorities should be allowed to unilaterally modify a grant of certification into a
denial of certification if that is deemed necessary to protect water quality. One commenter specifically
stated support for unilateral modification in the circumstances identified in the previous 40 CFR
124.55(b) for EPA-issued NPDES permits (i.e., if there is a change in state law or regulation upon which
certification is based or if a certification is stayed or remanded by a court or state board).

Some commenters stated that EPA should allow for certification revocations. A few of these commenters
recommended allowing revocations when done in accordance with the certifying authority's laws and/or
regulations. One commenter suggested that EPA change the provision to allow for a denial of certification
to be modified or revoked prior to the finalization of a Federal license or permit denial. Another
commenter recommended allowing a granted certification to be revoked or modified into a denial of
certification when new information is received pertaining to a project, which may substantively change
the scope of work that may result in a discharge. Another commenter suggested that EPA should add
language to clarify that the certifying authority retains the right to revoke the certification in
circumstances where the project proponent provided false or misleading information on which the
certification decision was based.

Some commenters specifically addressed the use of reopeners in certifications. One commenter asserted
that EPA should not restrict the use of reopener provisions. One commenter recommended that the final
rule make clear that certifying authorities can reopen certification based on a showing of changed
circumstances and ongoing effects of project operations fail to meet water quality standards. One of these
commenters asserted that certifications often include reopener and similar conditions and cited to a few
state regulations that the commenter viewed as authorizing reopeners or unilateral modifications. Another
commenter asserted that virtually every condition of one specific state certifying authority is subject to
further modification and provided an example of one such certification where the certifying authority
reserved the right to add or modify the conditions of certification under various specified circumstances.
One commenter stated that the proposed rule minimizes the enforcement role of the Federal agency and
the certifying authority, therefore, the inclusion of reopener conditions in a certification would allow a
certifying authority to address water quality concerns as long as the permit and certification is in effect.

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A few commenters agreed with EPA's proposed approach that would not allow unilateral modifications.
One commenter asserted that Federal permitting and licensing decisions are final agency actions and
project proponents rely upon their durability to make critical long-term decisions about project feasibility,
construction and operations. One commenter identified case law the commenter believed supports
allowing modifications with the approval of both the certifying authority and the Federal agency. See,
e.g., Snoqualmie Indian Tribe v. FERC, 545 F.3d 1207, 1219 (9th Cir. 2008); Airport Communities Coal.
v. Graves, 280 F. Supp. 2d 1207, 1214-17 (W.D. Wash. 2003). However, despite expressing opposition to
unilateral modifications, one commenter was open to a limited exception for purely clerical errors and the
like.

A few other commenters recommended that the final rule should prohibit "reopener" and similar
certification conditions that purport to allow certifying authorities to unilaterally add or revise
certification requirements after the reasonable period of time ends or after the issuance of the Federal
license or permit. A few commenters asserted that reopener conditions are plainly inconsistent with
section 401 because they allow certifying authorities to make certification decisions after the maximum
one-year period allowed by the statute and after the Federal license or permit had been issued. The
commenters continued that reopeners transform section 401's limited grant of authority to states to certify
Federal license and permit applications into an ongoing regulatory role. Another commenter asserted that
"reopeners" in certifications are contrary to the express and prescriptive provisions for post-certification
authority that Congress provided in CWA sections 401(a)(3) and 401(a)(4).

A few commenters argued that "reopener" conditions place an increased burden on the project proponent
and suggested that the certifying authority should have to prove that changes or modifications to a
certification will not have a significant impact on the project.

One commenter said states have also expressly reserved their authority to reopen the certification in
accordance with state law to assure the hydropower project's compliance with water quality requirements
over the 30- to 50-year license term. The commenter further added that reopener clauses are not unique to
certifications issued under section 401 and that several of FERC's standard license articles reserve its
authority to reopen a license for a variety of reasons. As another example, the commenter noted that
Biological Opinions issued pursuant to formal consultation requirements under Endangered Species Act
section 7 generally describe the circumstances in which the Federal agency may be required to reinitiate
consultation. The commenter asserted that such clauses allow projects to proceed despite the inherent
uncertainty involved in predicting project impacts on dynamic river systems, which are also more
vulnerable to accelerated changes in climatic conditions.

Agency's Response: The Agency recognizes the ongoing need to adapt to new and changing
information about water quality impacts of a project after a certification decision has been
issued, but the Agency is declining to broaden the final rule's modification provision to be a
mechanism to revoke or reverse a certification decision. See the Agency's Response to
Comments in Sections 9.1, 9.2, and 9.3.1.

Consistent with the Agency's longstanding approach to certification modifications, EPA is
finalizing the ability for a certifying authority to modify a grant of certification (with or

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without conditions) provided that the Federal agency and certifying authority agree in
writing that the certifying authority may modify the certification. Accordingly, EPA's final
rule does not authorize certifying authorities to unilaterally (Le., without Federal agency
agreement) "reopen" or modify a certification decision. The Agency disagrees with
commenters who stated that certifying authorities should be allowed to unilaterally modify
or revoke a section 401 certification decision if they have asserted this ability through a
"reopener" condition incorporated into the original certification decision. Certifying
authorities cannot bootstrap themselves greater authority to modify a certification beyond
what is authorized in this final rule at section 121.10. EPA is the Federal agency tasked with
administering and interpretating the CWA, see 33 U.S.C. 1351(d), 1361(a), including section
401, see Ala. Rivers Alliance v. FERC, 325 F.3d 290, 296-97 (D.C. Cir. 2003); NYSDEC, 884
F.3d at 453, n.33, and EPA's interpretation supersedes any contrary interpretation taken by
a certifying authority. However, EPA wishes to emphasize the distinction between reopener
clauses and adaptive management conditions, the latter of which are permissible under the
final rule. The text of an adaptive management condition does not change after certification
is granted. This promotes regulatory certainty, in contrast with a unilateral modification
pursuant to a "reopener" clause. See section IV.F for further discussion of adaptive
management conditions.

9.4 When Modifications May Occur

A few commenters argued that the certification modification process should not be allowed to upend the
licensing or permitting process once a license or permit is issued pursuant to an established process. One
commenter opposed open ended modification timeframes and suggested that the temporal limit for
modification be the day the Federal decision is issued to establish finality. Similarly, another commenter
asserted that modifications should not occur after a project that is in possession of valid permits
commences construction or becomes operational, except in extreme circumstances. Another commenter
expressed the view that allowing modifications without any regard to project timelines is very
problematic for construction and operational planning and stated there should be limits on the timeframe
for modifications, such as limiting modifications to ongoing projects only or by limiting modifications to
those initiated by the project proponent.

One commenter asserted that EPA should clarify that the certifying authority cannot modify its
certification after the issuance of the Federal license or permit that prompted the request for certification.
The commenter cited case law it viewed as supporting the position that modification after permit issuance
is not permissible. See Airport Cmtys. Coal. v. Graves, 280 F.Supp.2d 1207, 1215 (W.D. Wash. 2003)
("the plain language of the statute . . . reflects clear congressional intent that federal agencies only be
bound by state certification conditions issued within one year after notice"); City ofShoreacres v. Tex.
Com. ofEnv't Quality, 166 S.W.3d 825, 834-35 (Tex. Ct. App. 2005) ("states are not authorized under the
Clean Water Act to unilaterally revoke, modify, or amend a state water quality certification after the
certification process for a federal permit is complete").

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A commenter asserted that linking the Federal agency and certifying authority action should limit the
possibility for modifications because under Federal precedent, the CWA bars Federal agencies from
waiting more than a year to issue a permit even when a certification modification occurs after 1 year.

Many commenters supported there being no time limit for modifications. These commenters expressed
the view that modifications are necessary to reflect changing conditions, scientific understanding of water
quality effects, and changes to the project. Multiple commenters explained that placing a time limit on
modifications may impede the project proponent's ability to remain in compliance on projects with
unanticipated or unpredictable project scope and schedule changes and that restarting the certification
process because of a project change during construction could result in significant impacts to project costs
and public safety and would not be efficient, effective, or predictable. One commenter stated that
environmental or regulatory circumstances may change at any time between issuance and expiration of
the certification.

Agency's Response: After considering public comment, the Agency is promulgating a final
rule at section 121.10 that provides the opportunity for certification modification at any
point after certification issuance (until the expiration of the Federal license or permit),
provided the Federal agency and the certifying authority agree in writing prior to
modifying the grant of certification. As commenters noted, changes to an activity that have
significant implications for water quality can occur at any point in time after a certification
is granted. Accordingly, the Agency finds this approach best reflects the reality that
projects change over time and provides flexibility for project proponents, certifying
authorities, and Federal agencies to adapt to changing circumstances without needing to
reinitiate the certification process.

To the extent that commenters are asserting that case law bars any certification
modification after permit issuance, the Agency disagrees. While the Agency agrees that
certifying authorities may not unilaterally modify or revoke certification decisions once they
are issued, see the Agency's Response to Comments in Section 9.3, the Agency finds that a
grant of certification may be modified after its issuance (including after issuance of the
Federal license or permit) if agreed upon by the Federal licensing or permitting agency.
Neither case cited by the commenter reaches a different conclusion. See Airport Cmtys. Coal,
v. Graves, 280 F.Supp.2d 1207,1217 (W.D. Wash. 2003) (holding that section 401 only
required the federal agency to incorporate certification conditions issued within one year
from the request for certification and the Federal agency could use its discretion to
incorporate conditions issued after that point); City of Shoreacres v. Tex. Com. of Env't
Quality, 166 S.W.3d 825, 834-35, 837-38 (Tex. Ct. App. 2005) (finding that the certifying
authority could not unilaterally place additional conditions on the certification after the
certification process was complete).

The Agency disagrees with the one commenter asserting that the CWA bars Federal
agencies from waiting more than a year to issue a permit. Under section 401, when a
certifying authority receives a request for certification, the certifying authority must act on
that request within a "reasonable period of time (which shall not exceed one year)." 33

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U.S.C. 1341(a)(1). The plain language of section 401 does not extend this temporal limitation
to the issuance of a Federal license or permit. Once a certification or waiver is issued, and
the section 401(a)(2) process is complete, the Federal agency may decide whether or not to
proceed with the issuance of the Federal license or permit.

9.4.1 Statutory "Reasonable Period of Time " and Modifications

Some commenters argued that the text of the CWA includes temporal limits on the certifying authority's
authority over projects subject to section 401 and recommended that the final rule should not include a
provision for certification modifications, especially because it conflicts with the one-year limit for
certifying authority action. A few commenters argued that Congress defined and precisely time-limited
the ability of certifying authorities to review the potential impacts of federally licensed or permitted
projects. These commenters argued that the ability to modify or "reopen" a certification decision renders
the express time limits Congress imposed in section 401(a)(1) meaningless. One commenter argued that
EPA should not finalize a modification provision; however, the commenter recommended that if a
modification provision is finalized, no modifications to certifications should occur after the final Federal
license or permit is issued. One commenter argued that any modification must occur within 365 days of
receipt of the certification request and before the activity has commenced. Another commenter stated that
if modifications continue to be allowed only within the reasonable period of time, then the final rule
should include a requirement that the Federal agency must notify the certifying authority immediately
after any deficiencies are identified.

Conversely, a few commenters asserted that modifications are distinct from the original certification
"action," and recommended that EPA clarify that certification modifications should not be limited to the
reasonable period of time described in section 401(a)(1). Several commenters similarly expressed the
view that the timeframe for modifications should not be limited to the reasonable period of time. One of
those commenters asserted that the rule should allow for modification outside the reasonable period of
time if new information about a project becomes available because it builds efficiency into the process
and preserves time and resources while protecting water quality. Another commenter asserted that
modifications should be allowed for the duration of the certification, because some projects either last
decades or require multiple years of construction or several phases of work where substantive project
changes may be identified. The commenter noted that hydroelectric projects routinely operate under
adaptive management principles and anticipate changes to the project occurring during the span of the
license, and argued that as a result, it would be reasonable for the rule to allow certification modifications
when project operations are proposed that trigger new or expanded water quality impacts. Similarly,
another commenter asserted that certifications should be able to be modified at any point during the active
period of the permit.

One commenter expressed support for finalization of a modification provision, as long as the certifying
authority does not have the ability to unilaterally impose new conditions outside of the statutory one-year
reasonable period of time.

Agency's Response: EPA disagrees with commenters asserting that the ability to modify
would render the timeframes in section 401(a)(1) meaningless. Rather, EPA concludes that

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the best interpretation of section 401 is one that allows for modifications with reasonable
guardrails like the ones in this final rule. See Section IV.I of the final rule preamble for
further discussion on these guardrails. This interpretation is supported by the text of
section 401, which envisions the certifying authority participating in the Federal licensing or
permitting process after the issuance of a certification. See 33 U.S.C. 1341(a)(3)-(4). See
Keating v. FERC, 927 F.2d 616, 621-22 (D.C. Cir.1991) (summarizing section 401(a)(3)); see
also 115 Cong. Rec. 9257, 9268-9269 (April 16,1969) (discussing a hypothetical need for a
state to take another look at a previously certified federally licensed or permitted activity
where circumstances change between the issuance of the construction permit and the
issuance of the operation permit).

The Agency does not view modifications as contrary to the text of, or Congressional intent
supporting, the reasonable period of time limitation. First, on its face, the reasonable period
of time limitation only applies to the certifying authority's original action on the request for
certification. See 33 U.S.C. 1341(a)(1) (requiring a certifying authority to act on a request
for certification within a reasonable period of time not to exceed one year); see also 40 CFR
121.7(a)-(b) (interpreting the term "to act on a request for certification" to mean the
certifying authority must make a decision to grant, grant with conditions, deny, or expressly
waive certification within the reasonable period of time). The statute is silent regarding
subsequent modifications. Second, in imposing the reasonable period of time limitation,
Congress was concerned by the potential for the certifying authority's "sheer inactivity" to
delay the project. See H.R. Rep. 92-911, at 122 (1972). That concern is not present with
modifications to a grant of certification because the certifying authority will have already
acted on the request.

See Section IV.I of the final rule preamble for further discussion on limits to modifications
of certification decisions, including unilateral modifications; see also the Agency's Response
to Comments in Sections 9.3 and 9.4.

9.5 Participants in the Modification Process

9.5.1 Federal Agency Involvement in The Modification Process

Many commenters expressed concern over the Federal agency involvement in the proposed modification
process for various reasons. A few of these commenters asserted that Federal agency involvement could
be complicated. One commenter asserted that modifications are frequently needed for minor excursions
into time of year restrictions for CWA section 404 permits and asserted that the state should be able to
make such modifications with notification to the Federal agency and approval of the appropriate state or
Federal fish and wildlife agency. The commenter suggested that the rule could include a presumption that
a modification becomes final if the Federal agency does not comment within a certain timeframe (e.g., 5
days), noting that such modification requests are made during active dredge activities and are needed
quickly. A few commenters argued that the process for obtaining Federal agency agreement is ambiguous
and will be interpreted in a manner more restrictive than EPA intends.

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Some commenters asserted that the certifying authority is in the best position to determine if project
activities will meet water quality requirements, and that, conversely, Federal permitting agencies are often
poorly equipped to know how to protect the environment, especially when that is not their agency
mission. Another commenter expressed the view that the Federal agency's role should be removed,
stating that a modification reflects the certifying authority's input and interest in protecting state water
quality. A few commenters suggested that needing the Federal agency's consent will limit the flexibility
of certifications and permits to adapt to changing circumstances which EPA previously indicated it
wanted to prevent through this rulemaking. One commenter asserted that failure to allow states and Tribes
to modify certifications as they see fit may lead to two unintended consequences. First, the commenter
stated, when faced with the prospect of being forced to allow a project to operate for decades with no
opportunity to adapt to changing circumstances, some certifying authorities may be more inclined to deny
certifications outright. Second, according to the commenter, to mitigate against an inability to amend or
modify certification, a prudent certifying authority may be compelled to add additional measures to
protect against future harm.

Some of the commenters who supported the proposed process for Federal agency and certifying authority
agreement asserted that the Federal agency should not have a role in determining the specific language of
a modification for various reasons, including concern that adding a new conferencing and agreement
process could lead to delays and the fact that the Federal agency will not review certification content
during the original certification issuance. One commenter asserted that requiring the Federal agency to
agree to the language would allow Federal agencies to usurp the state or Tribe's authority. Conversely,
another commenter recommended that EPA adopt an approach where the actual language of the
certification modification would be agreed upon by both the Federal agency and the certifying authority.
The commenter asserted that this would foster cooperative federalism as Congress intended.

A few commenters argued that the proposed modification provision is contrary to Congressional intent to
preserve the states' primary authority over protection of water quality and the ability to impose
conditions, including "reopeners," outlined in section 401(d). See S.D. Warren v. Bd. ofEnvtl. Prot., 868
A.2d 210, 218 (Me. 2005) (explaining that the legally permissible "reopeners" were included as a
precaution in case the conditions instituted are not sufficient to ensure compliance with state water quality
standards and section 303 limitations). Another commenter argued that giving Federal agencies veto
power over modifications jeopardizes the balancing act between state and Federal agencies. See Keating
v. FERC, 927 F.2d 616, 622 (D.C. Cir. 1991) ("Congress intended that the states would retain the power
[under Section 401] to block, for environmental reasons, local water projects that might otherwise win
federal approval.").

One commenter asked that EPA clarify in the final rule what happens when the certifying authority and
Federal agency do not agree on a certification modification and whether or not the matter must be decided
in a court of law.

One commenter suggested that Federal agency concurrence should not be necessary for a modification
requested by the project proponent if the certifying authority also agrees with the need for the
modification.

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A few commenters recommended that the final rule include a provision for modifications to certifications
that includes more deference to the certifying authorities, including a few commenters who suggested that
EPA finalize a provision that does not restrict the ability of certifying authorities to modify or revoke
certifications by requiring Federal agency agreement. One commenter stated that as long as the certifying
authority explains the need for the modification, the Federal agency should not have a veto role and
should incorporate the modification into the Federal license or permit. Another commenter opposed the
inclusion of section 121.10(b) because section 401 certifications are essentially state permits and are not
subject to Federal review or veto.

Conversely, multiple commenters supported the proposed process whereby the Federal agency and the
certifying agency agree that changes are needed, without involving the project proponent or EPA. One
commenter requested that EPA clarify that the state and the Federal licensing or permitting agency may
outline standard practices for modifications to issued certifications in a Memorandum of Agreement to
avoid the burden of seeking agreement for each modification to an existing certification. The commenter
noted that such written agreement should address anticipated complications associated with coordination,
including which agency (state or federal) acts first in the coordination of modifications, circumstances in
which modifications to a certification also trigger modifications to the Federal permit, and considerations
of public notice during a certification modification.

One commenter recommended that EPA remove the requirement that the Federal agency must agree in
writing that the certifying authority can modify the grant of certification because it may be difficult to
obtain given heavy workloads and competing priorities or lack of interest. The commenter expressed
concern that prevention of modifications due to non-responsiveness would neither promote the protection
of water quality nor be in the interest of cooperative federalism. The same commenter also expressed
concern that a Federal agency, when acting as a project proponent, could use the proposed approach to
prevent modifications. Instead, the commenter recommended revising the rule to either require
notification and consultation with the Federal agency or provide the Federal agency with the opportunity
to object rather than requiring affirmative, written concurrence.

Agency's Response: As discussed in Section IV.I of the final rule preamble, EPA is
finalizing a provision for modifications to a grant of certification that balances the
certifying authorities' need for flexibility to protect water quality and the potential reliance
interests of project proponents and Federal agencies once the certifying authority has issued
a grant of certification. To achieve this balance, the final rule allows for modifications to
grants of certification at any point after certification issuance (until the expiration of the
Federal license or permit), subject to Federal agency agreement and without changing the
nature of the certification decision. Accordingly, the Agency declines to adopt commenter
suggestions to allow certifying authorities to modify certifications without agreement by the
Federal agency (with or without project proponent concurrence). This approach is
consistent with the Agency's longstanding practice and Congressional intent. See the
Agency's Response to Comments in Sections 9.3-9.4 and Section IV.I of the final rule
preamble for further discussion on the limitations to modifications of certification decisions.

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However, while the final rule requires the certifying authority and Federal agency to agree
to a modification, EPA agrees with commenters asserting that the Federal agency should
not have a role in determining the specific language of that modification. Congress
recognized certifying authorities as the "most qualified" to make decisions about impacts to
their water quality, and not Federal agencies. See 115 Cong. Rec. 29035, 29053 (Oct. 8,
1969) (Mr. Muskie: "By requiring compliance certification from the water pollution control
agency, [the certification provision] would assign policing responsibility to those agencies
most qualified to make an environmental decision and not to those committed to carrying
out some other function at minimum cost."). The Agency finds that certifying authorities
are best equipped to both determine the language of a certification decision and the
language of any subsequent modification to that decision. Because of commenter requests
for greater clarity regarding what the Federal agency gets to review prior to agreeing to a
modification, EPA is finalizing additional text in section 121.10(a) to clarify that the
certifying authority is not required to obtain the Federal agency's agreement on the
language of the modification. Rather, the certifying authority only needs Federal agency
agreement over the portions of the certification to be modified rather than the modified
language itself. The Agency notes that certifying authorities are free to discuss the
substance of a modification with a Federal agency but are not compelled to do so under this
final rule.

EPA agrees with commenters asserting that EPA should not have a role in the modification
process where it is not the certifying authority or Federal agency. As noted in the 2020 Rule
preamble, the statute does not expressly provide EPA with a role in the certification
modification process, unlike the Agency's other roles under section 401. See 85 FR 42278.
Additionally, although the 1971 Rule provided the Agency with an oversight role in the
modification process, the preamble to the 1971 Rule did not explain why. See 36 FR 8563-65
(May 8,1971). The Agency does not see the need to reintroduce such a role now, especially
where EPA was not involved in the original certification decision and is not the relevant
Federal permitting agency. EPA concludes that it should not have an oversight role in the
certification modification process.

EPA also agrees with commenters asserting that the project proponent should not have a
formal role in the modification process. See the Agency's Response to Comments in Section
9.5.2.

EPA appreciates commenter concerns regarding certifying authority workload associated
with obtaining Federal agency agreement to a modification. The Agency emphasizes that
this final rule encourages certifying authorities, project proponents, and Federal agencies to
communicate early and often in the certification process (e.g., pre-filing meeting provision)
to ensure parties develop a common understanding regarding the proposed project. Such
communicate may reduce the need for certification modifications. However, nothing in this
final rule precludes Federal agencies and certifying authorities from developing a process
for coordinating on certification modifications within the framework provided in this final
rule. For example, Federal agencies and certifying authorities may establish MOAs

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regarding circumstances that may require modification and/or modification coordination
procedures. Certifying authorities and Federal agencies are encouraged to work together to
address new information or changed water quality conditions throughout the life of the
project such that Congressional intent behind section 401—enabling states to protect their
water quality—can be preserved. In the spirit of cooperative federalism central to section
401, EPA expects that Federal agencies will not unreasonably withhold agreement to a
modification.

9.5.2 Project Proponent Involvement in the Modification Process

A few commenters recommended that EPA outline a way for the project proponent to participate in the
certification modification process because section 401 is framed around the role of the applicant, the
Federal agency and certifying authority may lack the technical knowledge, and often the project
proponent is initiating the project modification. One commenter stated that including the project
proponent in the modification decision or at least providing an opportunity for public notice is a more
transparent and legally defensible approach that considers the project proponent's reliance interests.

One commenter recommended that the project proponent have an active role in all discussions regarding
adding, removing, or revising conditions. The commenter included an exception that solely providing
notice to a project proponent regarding non-substantive administrative or ministerial modifications to a
certification may be sufficient.

One commenter encouraged the Agency to allow for flexibility to modify certifications in narrow
circumstances when it makes sense for the project proponent and Federal agency, but not to allow the
process to unnecessarily block or delay projects.

A few commenters asserted that the regulation should clearly indicate that the project proponent can
request a certification modification such as when there is a change in project scope or schedule. One
commenter requested that EPA clarify that a project proponent can request a certification modification
when there is a change in project scope or schedule because of heavy rainfall, unexpected emergencies, or
force majeure.

A few commenters expressed support for an approach where the project proponent must consent to the
modification. One commenter asserted that while requiring agreement by the Federal agency is an
important safeguard, only the project proponent will have unique insight into how belated modifications
affect the viability of the project and how to implement additional requirements. Another commenter
asserted that project proponents have faced situations where they need to make changes to the project and
that EPA should allow for project proponents to have a formal role in the modification process to ensure
accurate and efficient modifications consistent with project needs. One commenter suggested adding
language to the regulatory text to explicitly provide the project proponent with a consenting role.

One commenter expressed opposition to an approach where the project proponent must agree to a
modification. The commenter asserted that the project proponent will likely be involved in the process as
the certifying authority would likely need information from the project proponent and they would not be

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precluded from presenting their position on any modifications to the certifying authority. As such, the
commenter did not see the need for EPA to provide project proponents with a more explicit and expansive
role in the modification process.

Agency's Response: Consistent with the 1971 Rule, section 121.10 as finalized does not
provide the project proponent with a formal role in the modification process. However, the
Agency does not expect the process described in section 121.10 to prevent engagement with
the project proponent before or after the certifying authority and Federal agency have
agreed that the certifying authority may modify the previously granted certification. EPA
recommends that certifying authorities engage with the stakeholders who will be impacted
by a modification to the certification; some certifying authorities may even be required
under their regulations to make any proposed modifications to their certification decisions
available for public notice and comment.

9.6 General

9.6.1 Expiration Dates

A couple of commenters suggested that certifying authorities should set expiration dates on certification
decisions or waivers. One of these commenters said this would allow the certifying authority to verify that
its water quality requirements are being met. Another commenter expressed the need for certifying
authorities to be able to set certification decision expiration dates or to be able to reconsider waiver
decisions based on current science and technology, understanding of water quality, water quality
standards, and changes to a project scope, discharges, size, etc. because a Federal agency's ability to
unilaterally and continuously extend the certification or waiver a section 401 decision is antithetical to the
purpose of the CWA. The commenter stated that 33 CFR 325.6 provides that extension requests will be
granted unless contrary to the public interest, which is used as a flawed justification for a near-prohibition
on section 401 certification and waiver expiration dates.

Agency's Response: The Agency recognizes the ongoing need to adapt to new and changing
information about water quality impacts of a project after a certification decision has been
issued, but the Agency is declining to broaden the final rule's modification provision to be a
mechanism to revoke or reverse a certification decision. The Agency views a certification
condition setting an "expiration date" on the grant of certification as similar to a
"reopener" condition because it likewise purports to authorize the certifying authority to
unilaterally modify its grant of certification. See the Agency's Response to Comments in
Section 9.3.3. However, the Agency emphasizes that certifying authorities may develop
certification conditions in such a way that assure that the project will comply with water
quality activities over the life of the project. See Section IV.F of the final rule preamble for
further discussion on adaptive management conditions.

Likewise, EPA emphasizes that—for purposes of section 401—certification conditions
cannot "live on" past the expiration of the Federal permit to which they attach. Section
401(d) requires certification conditions to be incorporated into the Federal license or

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permit. Accordingly, once the Federal license or permit expires, any certification conditions
incorporated into the Federal license or permit also expire. This principle holds true
regardless of the scope of section 401. However, it does not mean that when a certifying
authority considers whether to grant or deny certification, the certifying authority is limited
to considering only those aspects of the activity that will occur before the expiration of the
Federal license or permit. For example, if the certifying authority determines that no
conditions could assure that the activity, including post-expiration aspects of the activity,
will comply with water quality requirements, denial of certification would be appropriate.

9.6.2 Defining Circumstances where Modification is Appropriate versus a New
Certification

A couple of commenters recommended that EPA develop a list of scenarios where modifications are
appropriate, however one of these commenters recommended that the list not be exclusive. A few
commenters expressed support for the modification process because the proposal does not define all
circumstances in which modification is appropriate. A few commenters recommended that EPA develop
guidance regarding scenarios where a new request for certification is necessary, instead of a certification
modification request, to provide clarity. Conversely, a. few commenters suggested that EPA should not
develop a list of scenarios warranting certification modification because there are several reasons a
project proponent may request a modification, including facility modifications.

A few commenters expressed agreement with the examples in the preamble for the proposed rule. One
commenter asserted that minor changes, such as needing to shift the certified "work window" to reduce
the amount of work occurring during high-flow periods, may not require a new certification but may be
significant enough to warrant modification of the certification. A few commenters asserted that the
proposal clearly identifies what may not be revoked or modified.

A few commenters requested clarity regarding the circumstances where a new certification or a
certification modification are appropriate. One commenter suggested that if the project has changed
materially after certification, such as the location or nature of the discharge is different from that certified,
it may be appropriate to issue a revised or new license or permit which would be subject to a new 401
certification.

One commenter requested that EPA provide the certifying authorities the ability to define what factors or
circumstances determine whether a modified project warrants a modified certification or a new
certification, especially when the Federal agency is the proponent for the modified project. Another
commenter noted that some certifying authorities are limited to addressing minor certification
modifications by state regulatory requirements and any project changes that do not meet the requirements
for a minor modification will require the project proponent to request a new certification.

One commenter, who stated that modifications would ensure that section 401 achieves its goal of ensuring
that Federal licenses or permits are consistent with state water quality goals and regulations, requested
that the final rule include language that clearly requires project proponents to submit a new certification
request and receive a new certification for any changes outside of what was proposed when the

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certification was issued if modifications are not available. Another commenter asserted that some project
proponents are likely to resist submitting a new request for certification, even if the certifying authority
finds it necessary to protect its water quality.

Agency's Response: After reviewing public comment, EPA is not finalizing a list of
scenarios that may warrant certification modification because the certifying authority and
Federal agency are in the best position to work together to determine whether a new
certification or a certification modification is appropriate in a given situation. Although
EPA understands the perspective of most commenters that it may be helpful to have
examples of circumstances where a modification to a certification may be appropriate, EPA
is declining to include a non-exhaustive list in the regulatory text so that certifying
authorities and Federal agencies retain the flexibility to determine their certification
modification needs after considering the local water quality and project-specific context.
Even without a list in the regulation, EPA still expects that the Federal agency will not
unreasonably withhold its agreement to modifications, especially for administrative edits,
such as correcting typographical errors, changing a point of contact, or adjusting a
certification's expiration date to reflect an updated license or permit expiration date.

Likewise, EPA is declining to finalize any bright line scenarios (e.g., specific new
information or changed circumstances) for when a modification is appropriate versus when
a new certification request is required. The Agency cannot anticipate all of the scenarios in
which one path may be appropriate over the other, nor can the Agency predict how state,
territorial, and Tribal certification modification processes will determine which path to
take. Beyond modifications to existing certifications, there may be circumstances that
warrant the submission of a new request for certification, such as if certain elements of the
activity (e.g., the location or size of the activity) change materially in a manner that could
impact water quality after a project proponent submits a request for certification. If the
activity changes so materially subsequent to the request for certification as to constitute a
different activity, this may warrant a new request for certification. The 2020 Rule preamble
also recognized this possibility. See 85 FR 42247 ("[I]f certain elements of the proposed
project (e.g., the location of the project or the nature of any potential discharge that may
result) change materially after a project proponent submits a certification request, it may
be reasonable for the project proponent to submit a new certification request.").

9.6.3 Federal Agency Modification Processes

A few commenters suggested that EPA does not need to finalize a provision for certification modification
because many Federal agencies have established processes for modifying the Federal license or permit
which already ensures that the process is transparent, includes applicable processes for project proponent
participation, and ensures that the Federal agency agrees to the specific modification that is incorporated
into the Federal license or permit. A few of these commenters argued that the section 401 process occurs
within the broader context of the Federal licensing or permitting process, therefore, certifying authorities
that wish to engage on a federally licensed or permitted project outside of the section 401 review period
likely have many other opportunities under the licensing or permitting process. One commenter noted that

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certification modifications after the Federal license or permit has been issued will require a corresponding
Federal license or permit modification. Another commenter asserted that because any modification to
certification conditions after issuance of the permit would necessarily be a modification to the Federal
license or permit itself, the proposal should be revised to make clear that the Federal agency's agreement
to the modification must be in accordance with the Federal agency's applicable license or permit
modification procedures. The commenter asserted that section 401 does not authorize EPA to give
Federal agencies the authority to agree to license or permit modifications without following the applicable
legal requirements for those modifications.

A few commenters recommended retaining 40 CFR 124.55(b) instead of the proposed section 121.10.
One commenter noted that EPA failed to describe any confusion, regulatory uncertainty, or other
problems attributed to the certification modification provisions in the NPDES program. See 40 CFR
124.55(b).

Agency's Response: EPA disagrees with commenter assertions that a modification provision
is unnecessary in light of Federal agency modification processes for Federal licenses or
permits. When the Agency revised the section 401 regulations in 2020, the rule did not
provide a process for modification of certification decisions after the certifying authority
had acted within the reasonable period of time; instead, the 2020 Rule preamble
acknowledged that certification modifications could occur through other mechanisms (e.g.,
as provided in other Federal regulations) and encouraged Federal agencies to establish
procedures in regulation "to clarify how modifications would be handled in these specific
scenarios." 85 FR 42279 (July 13,2020). The Agency acknowledges that the absence of a
modification provision in the 2020 Rule caused significant confusion during implementation
regarding whether and under what circumstances modifications to certification conditions
were allowed. Stakeholders also expressed significant support for the ability to modify
certification conditions, noting that minor changes may occur in the project that may not
rise to a level that requires a new certification (e.g., needing to extend the certification's
"expiration" date to match a permit extension, or shifting the certified "work window" to
reduce the amount of work occurring during high-flow periods), but may be significant
enough to warrant a modification of the certification. The final rule's modification
provision is responsive to commenter input and provides project proponents, certifying
authorities, and Federal agencies with the flexibility to address project changes and avoid
the burden of having to seek a new certification where the certifying authority and the
Federal agency agree.

The Agency notes that although this provision addresses a potential modification to a
certification after the certification modification is complete, EPA expects the Federal agency
to follow the appropriate Federal license or permit modification process when
incorporating any certification modifications into a previously issued Federal license or
permit.

EPA notes that the modification provision previously located at 40 CFR 124.55(b) only
applied to modifications to certifications for NPDES permits issued by EPA and did not

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extend to licenses and permits issued by other Federal agencies. Therefore, retaining 40
CFR 124.55(b) instead of the provision proposed at 40 CFR 121.10 would not have provided
additional clarity for stakeholders interested in modifying a certification for those licenses
and permits issued by other Federal agencies. Furthermore, EPA intends for section 121.10
to apply to all certification modifications, including those on certifications for EPA-issued
NPDES permits. Finally, EPA was concerned that leaving section 124.55(b) in place could
introduce stakeholder confusion when read with final rule section 121.10 because it may
have wrongly indicated that the circumstances in section 124.55(b) are the only
circumstances in which EPA might agree to modify a certification on an EPA-issued
NPDES permit, and as discussed in the final rule preamble, 124.55(b) conflicted with
several key features of this final rule's approach to modifications. However, nothing in this
final rule prohibits EPA in its capacity as a Federal permitting agency to continue to agree
to modifications to certifications in the types of circumstances previously prescribed in 40
CFR 124.55(b), as long as such modifications are consistent with section 121.10 of the final
rule. The final rule is broadening the circumstances under which the Agency might agree
with a certifying authority that a modification is appropriate for a certification of an EPA-
issued NPDES permit.

9.6.4 Clarification on Modifications to Certain Certification Decisions

One commenter requested that EPA include additional clarity in the final rule on whether or not
conditions can be added to a certification with conditions. The commenter also requested clarity on
whether a certification modification or a new certification are necessary if the project changes after
certification, but all conditions still apply and no new conditions are required by the certifying authority.

A few commenters requested that EPA clarify modifications to certification on general permits. One
commenter recommended that EPA avoid potential confusion by expressly allow certifying authorities to
deny blanket certifications for categories of projects eligible for general permits, such as the Corps'
section 404 NWPs, and then later issue individual certifications for projects seeking the general permit
authorization. One commenter asserted that because the certifying authority can only add conditions to a
grant of certification for a general license or permit upon agreement with the Federal agency, the
proposed rule appears to prohibit a certifying authority from exercising its authority where the certifying
authority becomes aware of an activity that would be authorized by a general license or permit that would
not comply with water quality requirements. The commenter recommended that EPA include a provision
under proposed section 121.10 that would provide certifying authorities with the authority to unilaterally
add special conditions to a grant of certification for a project authorized under a general license or permit,
when necessary to certify that the discharge will comply with its water quality requirements.

One commenter recommended that a project proponent should be allowed to revise their denied
certification request to bring it into compliance with water quality requirements so that it may be certified.

Agency's Response: Regarding whether conditions can be added via modification to a
certification with conditions, such a modification would be permissible under the final rule
as long as the process set forth in the final rule is followed. See Section IV.I of the final rule

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preamble. If the project changes after certification, but all conditions still apply and no new
conditions are required by the certifying authority, then no modification might be needed;
this will be up to the certifying authority and Federal agency to determine pursuant to the
process set forth in the final rule.

In response to the comment on denials of certification on the issuance of the Corps' NWPs
(and other Corps' general permits), the Agency does not view this situation as a
"modification." A denial of certification on the issuance of a Corps' general permit does not
preclude a project proponent from submitting (to a certifying authority) a project-specific
request for certification when seeking a general permit authorization; these would
constitute separate requests for certification.5 The same rationale applies to the comment
regarding revising a certification denial; there is nothing in the final rule prohibiting the
project proponent from revising its request for certification and resubmitting it to the
certifying authority. See Section IV.F of the final rule preamble for further discussion on
the effect of certification denials, including the continued viability of denials without
prejudice. Furthermore, the denial of certification for any Federal license or permit,
including the issuance of a general license or permit, would not be subject to modification
under the final rule because 40 CFR 121.10 only applies to grants of certification.

In response to the commenter asserting that the modification provision would prevent a
certifying authority from exercising its authority where the certifying authority becomes
aware of an activity that would be authorized by a general license or permit that would not
comply with water quality requirements, EPA disagrees. First, a certifying authority and
Federal agency may agree to modify a grant of certification on an individual or general
license or permit or may determine that a new request for certification is required.
Certifying authorities and Federal agencies are encouraged to work together to address new
information or changed water quality conditions throughout the life of the project such that
Congressional intent behind section 401—enabling states to protect their water quality—
can be preserved. In the spirit of cooperative federalism central to section 401, EPA expects
that Federal agencies will not unreasonably withhold agreement to a modification. Second,
as discussed in Section IV.J of the final rule, the Agency has consistently taken the view that
nothing in section 401 precludes states from enforcing certification conditions when so
authorized under state law. Additionally, the Agency views section 401 certification
conditions that are incorporated into the Federal license or permit as enforceable by
Federal licensing or permitting agencies. See Section IV.J of the final rule preamble for
further discussion on enforcement.

5 Note that the Corps is unique in allowing project proponents to seek authorization under a general permit where
certification was denied for the issuance of the general permit. See 33 CFR 330.4(c)(3) (stating "If a state denies a
required 401 water quality certification for an activity otherwise meeting the terms and conditions of a particular
NWP, that NWP's authorization for all such activities within that state is denied without prejudice until the state
issues an individual 401 water quality certification or waives its right to do so. State denial of 401 water quality
certification for any specific NWP affects only those activities which may result in a discharge. That NWP continues
to authorize activities which could not reasonably be expected to result in discharges into waters of the United
States.").

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9.6.5 Adaptive Management

Several commenters discussed adaptive management conditions in the context of modifications. One
commenter asserted that adaptive management conditions can be particularly important where future
water quality-related impacts may occur due to climate change or other events, noting that some Federal
permits and licenses can last for decades. Another commenter, who disagreed with allowing reopener
provisions or other unilateral modifications, had no concerns, in principle, with appropriately defined and
structured adaptive management conditions. According to the commenter, the former are open-ended
provisions that would allow fundamental changes in certification requirements; the latter are narrow,
structured mechanisms for adjusting specific certification requirements to changing conditions and new
information.

One commenter asserted that adaptive management conditions can benefit project proponents and make
the permitting process more efficient. To illustrate, the commenter provided an example of a certification
decision in Virginia where the project was able to proceed without waiting for all of the state's analyses to
be completed since the certification included an adaptive management approach where the project
proponent was still subject to further state approvals of its plans.

One commenter asked for additional clarity between adaptive management and modifications. To
illustrate the need for additional clarity, the commenter provided an example and asserted that it is unclear
whether changes to compensatory mitigation requirements because of mitigation bank limits would be
viewed as adaptive management or a certification modification.

Agency's Response: EPA wishes to emphasize the distinction between reopener clauses and
adaptive management conditions, the latter of which are permissible under the final rule.
Adaptive management conditions are set at the time the certification is granted and provide
a concrete action that must occur in the event certain criteria are met. The text of an
adaptive management condition does not change after certification is granted. This
promotes regulatory certainty, in contrast with a unilateral modification pursuant to a
"reopener" clause. For example, a condition may require a project proponent to increase
monitoring efforts or conduct remediation if the baseline, routine monitoring established in
the certification reveals an increase in a specific pollutant due to the activity. See section
IV.F for further discussion of adaptive management conditions.

9.7 Input Received on Prior Rulemakings

9.7.1 Input on the 2019 Proposed Rule

This sub-topic summarizes comments that were made on a previous proposed rulemaking and were
resubmitted by commenters in the docket for the 2022 proposed rule.

Some commenters argued that EPA should not finalize the 2019 proposed rule without a provision for
modifications. A few of the commenters asserted that while EPA should not have an oversight role in

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modifications to certifications, the ability to modify a certification decision is critical for a multitude of
reasons, such as to correct an aspect of a certification remanded or found unlawful by a Federal or state
court, or to accommodate project change requests by project proponents.

One commenter contended that certification modifications are allowed under the CWA; although Section
401 does not expressly provide such authority, the CWA also does not provide express authority for EPA
to modify permits issued under Section 402 or for the Corps to modify Section 404 permits. The
commenter continued that nonetheless, both agencies assume substantial authority to modify the permits
they issue so long as they follow their own notification and process procedures. Thus, the commenter
concluded that inherent within the power to issue CWA authorizations (such as a water quality
certification) is the authority to later modify such authorizations under circumstances established by EPA,
the agency charged with administering the CWA.

In an additional supporting argument, the commenter claimed that the reasonable period of time
restriction was introduced by Congress only to force prompt action, the commenter asserted that it was
never intended to prevent certifying agencies from later modifying certifications.

Another commenter provided regulatory text revisions to 40 CFR 121.2(b) from the 1971 Rule to allow
the certifying authority, Federal agency, and project proponent to agree to modifications, and all the
certifying authority to modify general permit certifications in agreement with the Federal agency.

Agency's Response: See Section IV.I of the final rule preamble and the Agency's Response
to Comments in Sections 9.1-9.6.

9.7.2 Pre-proposal Input from 2021

This sub-topic summarizes input that was received prior to the 2022 proposed rule and was resubmitted
by commenters in the docket for the 2022 proposed rule.

Most stakeholders requested that EPA restore a modification provision in the new rule. These
stakeholders provided general reasons that certification modifications are appropriate in situations where
a project proponent requests a modification to the project description/timing/location, where an aspect of
the approved proposal was determined to be unsafe, or where it is difficult to anticipate all potential
impacts of projects that occur over many decades, like hydroelectric dams and natural gas pipelines.
Another stakeholder asserted that it makes no sense to limit a certifying authority's ability to change their
water quality certification conditions, especially in a world where climate change is causing sea level rise,
and increased intensity of storms and at both ends of the hydrologic spectrum, from droughts to floods.

A few stakeholders argued that the 2020 Rule position regarding modifications was flawed because
disallowing "modifications plainly frustrates the Clean Water Act's preservation of states' authority to
protect their waters and section 40 l's goal of assuring that Federal licensing and permitting agencies
cannot override state water quality protections." The stakeholder argued that modifications to a
certification are not in conflict with the one-year statutory timeframe for issuing certification decisions
because modifications based on, for instance, a change to the project or changed water quality

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requirements does not implicate Congress' concern over states failing to take action on a certification
request. Therefore, the stakeholder concluded that EPA should restore the modification provision which
the commenter asserted is within the statutory framework and worked well for decades prior to the 2020
Rule as a practical, common-sense tool to address changed circumstances.

Some of the stakeholders recommended that EPA develop a new modification provision with
participation from the project proponent - arguing either 1) modifications should only be allowed at the
request of the project proponent, or 2) the certifying authority should only be allowed to modify the
certification if both the Federal agency and the project proponent agree to the modification. One
stakeholder asserted that certification modifications should be authorized for conforming edits only after
the lead Federal agency approves changes (e.g., re-routes to avoid newly identified resources or changes
in construction methods to address site-specific constraints).

Most of the stakeholders asserted that the 2020 Rule approach to modifications did not provide clarity or
flexibility for any of the stakeholders involved; some of the stakeholders stated that requiring a project
proponent to seek a new certification instead of a modification is a bureaucratic exercise that serves no
good purpose for any of the parties involved, wasting valuable agency resources, and frustrating the
regulated public.

One stakeholder recommended that certifying authorities make changes to certifications, corresponding to
license or permit changes, after following the appropriate state or Tribal procedures (e.g., public notice
requirements).

Another stakeholder expressed support for the 2020 Rule's limits on a certifying authority's ability to
unilaterally modify the certification decision after the reasonable period of time; however, the stakeholder
encouraged adding flexibilities to the rule if the project proponent is involved in development of the
modification with the certifying authority because such an approach is "common sense."

Agency's Response: See Section IV.I of the final rule preamble and the Agency's Response
to Comments in Sections 9.1-9.6.

10. Enforcement and Inspection

10.1 Enforcement

Most commenters supported EPA's proposal to remove the language at 40 CFR 121.11(c) regarding
Federal agency enforcement of certification conditions. Almost all of these commenters argued that, at a
minimum, states and Tribes should be able to enforce certifications and certification conditions where
authorized under state or Tribal law, or alternatively, under the citizen suit provision of the CWA. Many
commenters requested that EPA expressly state in the new rule that certifying authorities, including states
and Tribes, have independent authority under the CWA to enforce certifications and certification
conditions, and requested EPA clarify that enforcement under the citizen suit provision and state and
Tribal law are simply alternative bases for enforcement.

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Many commenters supported their positions by raising concerns over cooperative federalism and Federal
agencies' willingness or capacity to enforce certifications and certification conditions. For example, some
commenters asserted that Federal agency resource limitations coupled with the large jurisdictional
territories necessitate that states and Tribes be able to enforce certifications and certification conditions,
otherwise the conditions may never be enforced. Some of these commenters also argued that some
Federal permitting or licensing agencies may not support a particular certification condition, and therefore
the inability of certifying authorities to enforce conditions may result in discretionary enforcement or
under-enforcement. At least one commenter asserted that, given recent Supreme Court case law on Indian
Territory, EPA should clarify that state authority to enforce state law requirements within Tribal
jurisdictions is preempted by Tribal and Federal jurisdiction over Tribal waters.

One commenter asserted that certifying authority enforcement of certification conditions makes sense,
because there may be other state law requirements involved that may be outside the scope of the
certification but involve the same operative set of facts.

A few commenters asserted that EPA should remain silent on the issue of enforcement because the statute
and case law are sufficiently clear.

Some commenters disagreed with EPA's proposal to remove the language at 40 CFR 121.11(c) and
argued that the enforcement of certification conditions incorporated into Federal license or permits must
lie exclusively with the Federal permitting and licensing agencies. One commenter suggested that the
final rule should include a statement to clarify that enforcement of conditions is the responsibility of the
Federal agency and that enforcement of conditions is to be done through the inclusion of conditions into
the Federal license or permit. Most of these commenters argued that there is no explicit authority in the
CWA, including in the citizen suit provision, to allow certifying authorities to enforce certification
conditions. One of these commenters argued that there is no provision in the CWA for enforcement of
certification conditions other than through the requirement to incorporate the conditions into Federal
licenses or permits. Many of these commenters argued the new regulatory text will lead to confusion,
unnecessary litigation, and possibly duplicative or inconsistent enforcement actions and conditions. One
commenter argued that by allowing certifying authorities to enforce subjective and expansive certification
conditions, certifying authorities may cause adverse socioeconomic and environmental impacts by stalling
federally licensed projects. A few commenters requested EPA clarify that the ability of any certifying
authority to bring an enforcement action ends once the licensed or permitted activity ends. One
commenter asserted that there is no mechanism under the CWA to give effect to a certification decision
independent of a Federal license or permit and conditions do not have any effect pending the issuance of
the license or permit.

Agency's Response: EPA observes that this final rule is generally focused on interpreting
the text of section 401 itself, and not other provisions of the CWA. Section 401 does not
directly address state or Tribal enforcement authority and the Agency is declining to add
regulatory text on that issue. Consistent with the approach taken in the 2020 Rule, this
rulemaking does not include interpretations of other enforcement-related sections of the
CWA, such as section 505. As such, the Agency is not adding regulatory text to address state
or Tribal enforcement authority with respect to section 505. EPA is not offering new

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interpretations or positions on the issues discussed below but appreciates the time and effort
that commenters dedicated to this discussion.

As an initial matter, the Agency views section 401 certification conditions that are
incorporated into the Federal license or permit as enforceable by Federal licensing or
permitting agencies. This position is consistent with the statute and longstanding practice,
and nearly every commenter agreed on this position. Section 401(d) provides that if a grant
of certification includes any conditions, those conditions "shall become a condition on any
Federal license or permit." As a result, the Federal agency can enforce any such conditions
in the same manner as it can enforce any other conditions of its license or permit. EPA
expressed this interpretation in the 2020 Rule, 85 FR 42275-76, and a decade prior to that
rulemaking. See, e.g., 2010 Handbook at 32 (rescinded in 2019). EPA also observes that
Federal agencies have considerable discretion in deciding whether and when to enforce
requirements and conditions in their licenses and permits. See Heckler v. Cheney, 470 U.S.
821, 831 (1985) (discussing why it is important for agencies to retain enforcement
discretion).

However, EPA is not retaining Section 121.11 from the 2020 Rule, which included text
regarding the enforcement of and compliance with certification conditions. As discussed in
Section IV.J of the final rule preamble, this regulatory provision introduced ambiguity into
the Agency's longstanding position that nothing in section 401 precludes states from
enforcing certification conditions when authorized under state law (and not precluded by
other Federal law besides section 401). It has also led to stakeholder confusion over whether
the 2020 Rule prevented states and Tribes from exercising their independent enforcement
authority and whether the 2020 Rule limited Federal agency discretion regarding their
enforcement of section 401 conditions in their licenses or permits.

The Agency has consistently taken the view that nothing in section 401 precludes states
from enforcing certification conditions when so authorized under state law. In the 2020
Rule preamble, the Agency concluded that "[njothing in this final [2020] rule prohibits
States from exercising their enforcement authority under enacted State laws." 85 FR 42276.
EPA did, however, consider this authority limited to "where State authority is not
preempted by federal law." Id. A decade prior to the 2020 Rule, EPA had already
recognized that states enforce certification conditions when authorized to do so under state
law. See e.g., 2010 Handbook at 32-33 (rescinded in 2019) ("Many states and tribes assert
they may enforce 401 certification conditions using their water quality standards
authority.").

EPA disagrees that Federal and certifying authority enforcement will lead to confusion or
duplicative actions. After over 50 years of section 401 implementation experience, EPA
expects that certifying authorities and Federal agencies are well-versed in coordinating
enforcement actions. Nevertheless, EPA recommends that certifying authorities clearly
indicate which certification conditions derive from state or Tribal law.

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With respect to CWA citizen suits and their application to both the requirement to obtain
section 401 certification and the requirement to comply with certification conditions, some
courts have addressed these issues. First, the Ninth Circuit Court of Appeals held that
citizen suits may be brought to enforce the requirement to obtain certification. ONDA v.
Dombeck, 172 F.3d 1092,1095 (9th Cir. 1998). In ONDA, the court rejected the argument
that CWA section 505 authorizes only suits to enforce certification conditions but not the
requirement to obtain a certification. The court pointed to the plain language of section 505,
which cross-references the entirety of section 401 (and not, for example, only section 401(d),
which concerns certification conditions). Id. Second, a few Federal courts have held that
certification conditions can be enforced through CWA citizen suits. In Deschutes River
Alliance, a U.S. district court considered the issue at length and ultimately held that CWA
section 505 authorizes citizens to enforce certification conditions. See Deschutes River
Alliance v. Portland Gen. Elec. Co., 249 F. Supp. 3d 1182,1188 (D. Or. 2017) (considering
the issue with respect to a FERC license); see also Pub. Emps. for Envtl. Responsibility v.
Schroer, No. 3:18-CV-13-TAV-HBG, 2019 WL 11274596, at *8-10 (E.D. Tenn. June 21,
2019) (relying in part on Deschutes River Alliance and considering the issue with respect to a
section 404 permit issued by the Corps). EPA is not aware of any Federal court that has
considered the issue and reached the opposite conclusion. Deschutes River Alliance also
noted that certifying states (in addition to the citizen group before the court) are among the
persons that may enforce certification conditions via the CWA citizen suit provision. 249 F.
Supp. 3d at 1191-92. The court reasoned that section 505 is the only provision of the CWA
that could bestow Federal authority upon states to enforce certification conditions and,
given this, interpreting section 505 to preclude state enforcement of certification conditions
would run "contrary to the CWA's purpose and framework."Id. at 1191.

In response to comments regarding enforcement actions after the end of a licensed or
permitted activity, EPA emphasizes that—for purposes of section 401—certification
conditions cannot "live on" past the expiration of the Federal permit to which they attach.
Section 401(d) requires certification conditions to be incorporated into the Federal license
or permit. Accordingly, once the Federal license or permit expires, any certification
conditions incorporated into the Federal license or permit also expire. Therefore, EPA
agrees that enforcement actions cannot be brought to enforce CWA section 401 certification
conditions that were incorporated into since-expired Federal licenses or permits.

Regarding the commenters' request for clarification that Indian country waters would, for
CWA purposes, be subject to federal and tribal, and not state, jurisdiction, EPA agrees, as
the commenter notes, that prior EPA statements are relevant to, and to a large extent
already address, that issue. See, e.g., 81 Fed. Reg. 30183, (May 16, 2016) (explaining that the
CWA includes a delegation of authority from Congress to eligible Indian Tribes to
administer CWA programs over reservation waters). EPA believes it is unnecessary to
address the commenters' request further in the current rulemaking. EPA has explained in
the preamble to the current rulemaking that in administering section 401 certification
programs, approved Tribes would effectuate the delegation of congressional authority over

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their entire reservations. It is outside the scope of the current rulemaking to address
jurisdictional issues as between states and Tribes with greater specificity.

10.2 Inspection

10.2.1	Regulatory Text on Section 401(a)(4)

A few commenters recommended adding regulatory text regarding section 401(a)(4). A few of these
commenters recommended that EPA adopt regulatory text regarding its proposed interpretation of the
term "review" found in section 401(a)(4). One commenter recommended adding regulatory language that
requires that certifying authorities be afforded the opportunity to conduct inspections of a facility prior,
during, and after the certified project has commenced. Another commenter stated that EPA's
interpretation of section 401(a)(4) is sound and recommended that EPA codify it to ensure that authorized
Tribes' authority to inspect and review project facilities and activities is unequivocally clear.

Agency's Response: As mentioned in section IV.J of the final rule preamble, EPA is not
retaining any of the regulatory text from the 2020 Rule regarding inspection authority,
previously located at 40 CFR 121.11 (2020). The Agency finds that the statute clearly
outlines the inspection authorities available under section 401. On its face, section 401(a)(4)
applies to a limited circumstance where a Federal license or permit and certification are
issued prior to operation of the facility or activity and a subsequent Federal operating
license or permit is not necessary for the facility or activity to operate. Under these limited
circumstances, the statute is clear that the licensee or permittee must provide the certifying
authority with the ability to "review" the facility or activity to determine whether it will
comply with effluent limitations, other limitations, or other water quality requirements.

Furthermore, after considering public comments, EPA finds it unnecessary to add
regulatory text defining the term "review" as used in section 401(a)(4). The issue did not
receive significant commenter interest, and EPA is not aware of current disputes regarding
the issue. Nonetheless, EPA is restating in this final rule its interpretation that the term
"review" found in section 401(a)(4) is broad enough to include inspection, but it is not
necessarily limited to inspection. It arguably also includes the right to review preliminary
monitoring reports or other such records that can assist the certifying authority in
determining whether the operation of the facility or activity will comply with effluent
limitations, other limitations, or other water quality requirements.

10.2.2	Removing Current 121. ll(a)-(b)

One commenter expressed support for EPA's proposal to remove 121.1 l(a)-(b) from its certification
regulations.

Agency's Response: EPA is removing section 121.11(a)-(b) from the 2020 Rule in this final
rule because the 2020 Rule incorrectly interpreted the limited applicability of section
401(a)(4) and the statutory language does not need further clarification.

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10.2.3 Whether Section 401(a)(4) or Section 401 Limits Certifying Authority Enforcement
Authority

A few commenters agreed with EPA's proposed interpretation that section 401(a)(4) does not necessarily
limit a certifying authority's ability to inspect facilities or activities before or during operation in
accordance with the certifying authority's laws.

One commenter interpreted EPA's proposal as authorizing certifying authorities to inspect federally
licensed or permitted facilities at any time and for any purpose. The commenter then asserted that such a
proposal would be plainly precluded by section 401(a)(4), arguing that section 401(a)(4) describes the full
extent of a state's post-certification inspection authority under Section 401. However, the commenter also
stated that some states have state or federally delegated authority to inspect Federal facilities for
environmental compliance outside of what section 401 authorizes. The commenter continued that, far
from authorizing inspections at any time or opening the door to a certifying authority's enforcement of
certification conditions, section 401(a)(4) only allows the certifying authorities to notify the permitting or
licensing agency. The commenter concluded that section 401(a)(4) then expressly describes the Federal
agencies' discretion to determine whether to bring an enforcement action pursuant to the certifying
authority's recommendation.

Agency's Response: EPA emphasizes that section 401(a)(4) does not necessarily limit the
certifying authority's ability to inspect facilities or activities before or during operation in
accordance with the certifying authority's laws and regulations. The Agency is aware that
states and Tribes may have their own authority to inspect a facility or activity to determine
compliance with conditions set forth in a section 401 certification and section 401(a)(4) does
not preclude those inspections pursuant to those authorities. Similarly, section 401(a)(4)
does not necessarily limit a Federal agency's ability to inspect a facility during the life of the
license or permit pursuant to that Federal agency's laws and regulations. The Agency
disagrees that this interpretation enables certifying authorities to inspect federally licensed
or permitted facilities at any time and for any purpose, as the purpose and scope of any
inspection must be in accordance with certifying authority's laws and regulations as well as
any other Federal laws or regulations limiting the ability of a certifying authority to inspect;
EPA is simply concluding in this final rule that section 401(a)(4) is not one such Federal law.

10.3 Input Received on Prior Rulemakings

10.3.1 Input on the 2019 Proposed Rule

This sub-topic summarizes comments that were made on a previous proposed rulemaking and were
resubmitted by commenters in the docket for the 2022 proposed rule.

In its comment on the 2019 proposed rule, one commenter suggested that EPA clarify that certifying
authorities' authority to review an activity or facility prior to initial operation and Federal agencies'
incorporation of conditions into the Federal license or permit are separate and distinct. The same
commenter asserted that the inspection provision was appropriately limited to determining whether during

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operation the discharge will comply with the certification already issued, and requested that EPA clarify
that if the initial operation of the facility would not result in a discharge, then the certifying authority shall
not be afforded an opportunity to inspect the facility, pursuant to Section 401, prior to operation.

Commenters on the 2019 proposed rule did not agree that enforcement should be limited to Federal
agencies. One commenter requested that EPA clarify that state certifying authorities may retain
independent authority to enforce states' legal requirements. Another commenter asserted that the 2019
proposed rule wrongly claimed that a state does not have any authority to enforce certification conditions,
arguing that it was contrary to case law and cooperative federalism principles in the CWA. The
commenter further argued that if states cannot enforce water quality protection measures it imposes on a
project, then the process is meaningless. The commenter also stated that the 2019 proposed rule would
attempt to substitute the state's expertise with the judgment of the Federal agency.

One commenter requested that EPA clarify that section 401 does not provide Federal agencies with
independent authority to enforce certification conditions, but rather a Federal agency draws on its own
licensing or permitting authority to enforce any provision of the Federal license or permit. Accordingly,
the commenter recommended that EPA should limit the regulatory text to recognizing that certification
conditions become conditions on the license or permit.

Agency's Response: See the Agency's Response to Comments in Sections 10.1-10.2; see also
Section IV.J of the final rule preamble.

10.3.2 Pre-proposal Input from 2021

This sub-topic summarizes input that was received prior to the 2022 proposed rule and was resubmitted
by commenters in the docket for the 2022 proposed rule.

Stakeholders disagreed that certification condition enforcement should be limited to Federal agencies.
One stakeholder asserted that states or Tribes may have independent authority to enforce the applicable
water quality requirements upon which the condition is based. Another stakeholder argued that state
agencies are best suited to enforce provisions of state law, not Federal agencies, and recommended that
the 2020 Rule be modified to make it clear that a state may enforce certification conditions. The
stakeholder also asserted that the 2020 Rule improperly purported to provide Federal agencies with
exclusive enforcement authority, which is inconsistent with the CWA's cooperative federalism structure.

One stakeholder asserted that section 401 makes it clear that a certification is a state permit that may be
enforced by the state. The stakeholder noted that just because Federal agencies gain the authority to
enforce section 401 certification conditions as part of the Federal permit does not displace the state's
authority to enforce the certification. The stakeholder also asserted that at least one Federal district court
rejected a similar interpretation as the 2020 Rule in another context. United States v. S. California Edison
Co., 300 F. Supp. 2d 964, 980-81 (E.D. Cal. 2004). Another stakeholder, who argued that the 2020 Rule
deprives states and Tribes of actual enforcement authority, asserted that courts have recognized that states
and Tribes have primary responsibility for enforcing compliance with certification conditions. See e.g.,
Roosevelt Campobello Int'lPark com. v. EPA, 684 F.2d 1041, 1056 (1st Cir. 1982) ("the proper forum to

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review the appropriateness of a state's certification is the state court, and that federal courts and agencies
are without authority to review the validity of requirements imposed under state law or in a state's
certification"); NRDC v. EPA, 279 F.3d 1180, 1188 (9th Cir. 2002) ("the EPA does not act as a reviewing
agency for state certification, and the proper forum for review of state certification is through applicable
state procedures"); Proffittv. Rohm & Haas, 850 F.2d 1007, 1009 (3d Cir. 1988) ("only the state may
review the limits which it sets through the certification process"); United States v. Marathon Dev. Corp.,
867 F.2d 96, 102 (1st Cir. 1989) ("The proper forum for such a claim is state court, rather than federal
court, because a state law determination is involved.").

One stakeholder requested that EPA provide states and Tribes with explicit enforcement authority in a
new rule to ensure the project proponent complies with water quality requirements. The stakeholder
discussed its experience with the 2020 Rule, noting that the 2020 Rule's approach to enforcement had
severely limited its role in ensuring its water resources are protected.

One stakeholder asserted that EPA provided no legal analysis for its suggestion that the CWA citizen suit
provision may apply to section 401 and noted that the citizen suit provision expressly recognizes that it is
limited by the States' sovereign immunity.

Agency's Response: See the Agency's Response to Comments in Sections 10.1-10.2; see also
Section IV.J of the final rule preamble.

11. Neighboring Jurisdictions (Sections 121.12-121.15)

11.1 General

11.1.1 Coordination and Engagement in the Neighboring Jurisdiction Process

Several commenters discussed the need for collaboration between EPA and other stakeholders prior to
initiation of the neighboring jurisdiction process. A few commenters recommended that EPA provide a
mechanism for notifying neighboring jurisdictions to determine whether there are objections to the project
before the certification is granted by the certifying authority. These commenters argued that early
coordination with the neighboring jurisdiction would limit the number of projects that are forwarded to
the Regional Administrator and potentially delayed. One of these commenters said that EPA could make
neighboring jurisdictions aware of existing public notice processes and develop a mapping tool that
project proponents could review while scoping for their projects and before submitting a request for
certification.

A few of these commenters suggested that EPA should consider establishing a collaboration between the
Regional Administrators, Federal agencies, and certifying authorities to discuss the circumstances that
may affect neighboring jurisdictions before certification decisions. One commenter suggested adding
language which allows the option for a procedure to be developed between certifying agencies, Federal
agencies, and the Regional Administrator. Similarly, another commenter said that there should be a
collaborative process between the Regional Administrator, Federal agencies, and neighboring
jurisdictions to develop a process and requirements for review and inter-jurisdictional discharges. The

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commenter stated that this would ensure that increased discharges due to more intense precipitation
events in upstream events will not adversely affect a neighboring jurisdiction's waters, and that it would
aid in equity and environmental justice for disadvantaged communities.

A commenter said that EPA has a responsibility to proactively work with project proponents and other
Federal agencies as early as possible in the project review and permitting process. The commenter
suggested the incorporation of further information on the role of EPA in the final rule and/or in
implementation guidance. The commenter stated that EPA should help identify water quality issues and
anticipate any necessary evaluations of neighboring jurisdiction effects. This commenter added that
outreach to potential jurisdictions should also occur to allow for early collaboration.

Agency's Response: EPA agrees that early coordination can generally be beneficial to all
parties, though this may not always be necessary depending on project complexity and
resources. The Agency has encouraged early coordination and communication throughout
the final rule, including pre-filing meeting requests and request for certification.
Additionally, EPA observes that section 401 requires certifying authorities to develop public
notice procedures for requests for certification. See 33 U.S.C. 1341(a)(1). A certifying
authority's public notice procedures for certification could provide an additional
opportunity for neighboring jurisdictions and other stakeholders to participate in the
process. Generally, early engagement can provide stakeholders the opportunity to
communicate needs and requirements, potentially streamlining processes and helping
ensure any concerns are noted and addressed.

EPA disagrees with one commenter's assertion that EPA has a responsibility to proactively
work with project proponents and other Federal agencies as early as possible in the Federal
licensing or permitting process, or commenters' assertion that the Agency should develop a
regulatory process for coordination between EPA, certifying authorities, and Federal
agencies. EPA has a specific, statutorily defined role in the neighboring jurisdictions
process, which does not require the Agency to proactively coordinate with other Federal
agencies, project proponents, and/or certifying authorities. See Section IV.K.2.f for further
discussion on EPA's role in the neighboring jurisdictions process.

11.1.2 Neighboring Jurisdiction Procedures

A commenter expressed concern about additional time needed to complete the section 401(a)(2) process
and asserted that the process adds delay and uncertainty. Similarly, another commenter asserted that the
section 401(a)(2) analysis was overly burdensome on the regulated public and state agency staff.

One commenter supported EPA's proposal to largely retain the 2020 Rule's regulatory approach to
Section 401(a)(2), asserting that this increased clarity and predictability of the procedural requirements in
section 401(a)(2). Another commenter also supported EPA's proposed approach to addressing
neighboring jurisdiction and encouraged the Agency to consider how to best balance the neighboring
jurisdiction concerns with the benefits associated with timely approval of mining projects that offer
societal benefits. The commenter also voiced general support for EPA's existing section 401(a)(2) best

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practices document and stated support for a science-based approach that requires actual demonstration of
effects before EPA makes a determination.

One commenter noted that additional detail provided in the proposed rule about the 401(a)(2) process
would increase certainty and predictability and recommended that such clarifying detail should be
included in the final rule preamble and rule text. The commenter asserted that EPA previously provided
little, if any, information about factors it will consider when making a "may affect" determination, what
EPA considers to be a "neighboring jurisdiction" for purposes of section 401(a)(2), what neighboring
jurisdictions should include in a 401(a)(2) objection to a proposed permit, and other details. According to
the commenter, many states and Tribes found the lack of detail in how section 401(a)(2) processes would
work to be unhelpful, citing input provided by other commenters.

Agency's Response: In response to commenter concerns regarding the time or burden
associated with the neighboring jurisdiction process, the Agency notes that the neighboring
jurisdictions process is a component of the section 401 statutory regime established by
section 401(a)(2) and is not a regulatory creation by EPA. Moreover, as section 401(a)(2)
sets timelines for certain actions in the neighboring jurisdictions process, it is clear from the
statutory text that Congress considered the timing of this process when it was established.
As discussed in Section IV.K of the final rule preamble, EPA is adding clarity regarding the
procedures involved in the neighboring jurisdictions process in the final rule, which are
intended to improve efficiency and reduce the time necessary for this process.

In response to the commenter asserting that the Agency must make an actual determination
of effects before EPA makes a may affect determination, EPA strongly disagrees. Unlike the
standard applied by notified neighboring jurisdictions in making a determination regarding
an objection, the standard applied by EPA in its "may affect" analysis does not require
consideration of whether water quality effects of discharge from the project will result in
violation of water quality requirements. Instead, the standard applied by EPA in its "may
affect" determination only requires analysis of whether discharge from the project may
have water quality effects on a neighboring jurisdiction. Additionally, the "may affect"
standard, in contrast to the standard applied by notified neighboring jurisdictions, does not
require a finding that the discharge "will" effect water quality. Accordingly, EPA finds this
standard may be met where there may be an effect to a neighboring jurisdiction's water
quality, but such effect is not certain to occur.

11.1.3 Defining Neighboring Jurisdiction

A few commenters provided input on the definition of "neighboring jurisdiction." One commenter
supported the proposed definition of "neighboring jurisdictions." Another commenter stated that it was
appropriate for EPA to clarify that a neighboring jurisdiction's status stems from its geographical location
as opposed to EPA's determination that such jurisdiction may be affected by a discharge from another
jurisdiction.

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One commenter expressed support for the 2020 Rule definition of "neighboring jurisdiction" and argued
that the definition should include language about a neighboring jurisdiction's water quality. A different
commenter suggested the following definition: "neighboring jurisdiction means any state, or tribe with
treatment in a similar manner as a state for Clean Water Act section 401 in its entirety or only for Clean
Water Act section 401(a)(2), which is adjacent to the jurisdiction in which the discharge originates or will
originate, and whose water quality has the potential to be affected by a proposed discharge as a result of
being down-gradient or having a similar hydrologic relationship with the project site." Another
commenter suggested that EPA adopt a definition of neighboring jurisdiction that would limit this term as
encompassing states and Tribes with TAS for section 401 only when they are adjacent to the jurisdiction
where the discharge originates or will originate, and their water quality may be affected as a result of
being downgradient or having a similar hydrologic relationship.

One commenter said that Tribal rights over waters within treaty ceded territories will continue to be
overlooked in this process by continuing to limit "neighboring jurisdictions" to only Tribes that have
TAS. The commenter said that ignoring the existence of these off-reservation water rights run contrary to
the Administration's ongoing efforts to support water quality in these areas.

Agency's Response: The Agency is finalizing the definition of neighboring jurisdiction at
section 121.1(g) as proposed. EPA disagrees with commenters suggesting a narrower
definition of neighboring jurisdiction. EPA finds that a narrower definition of neighboring
jurisdiction is not supported by the statutory text in section 401(a)(2), which establishes a
process for considering water quality effects to "any other state." This statutory language
does not impose any other requirement on a neighboring jurisdiction other than not being
the jurisdiction in which the discharge originates or will originate, meaning the jurisdiction
with certifying authority. Accordingly, EPA declines to adopt a narrower definition of
neighboring jurisdiction. Additionally, EPA notes that the definition of neighboring
jurisdiction makes clear that this term is not limited to adjacent or downstream states or
Tribes with TAS for section 401, consistent with the relevant statutory language in section
401(a)(2).

In response to the commenter expressing support for the 2020 Rule's definition of
neighboring jurisdiction, the Agency notes that the definition of "neighboring jurisdiction"
in the 2020 Rule inaccurately suggested that a neighboring jurisdiction may only include a
state or TAS Tribe that EPA determines may be affected by a discharge from another
jurisdiction. A neighboring jurisdiction's status is not based upon EPA's "may affect"
determination, but rather a neighboring jurisdiction has this status by being a jurisdiction
other than the one where the discharge originates or will originate. Thus, the current
definition is more consistent with the statutory text establishing the process set forth in
section 401(a)(2) for purposes of considering the water quality effects to "any other state"
than the previous definition for the 2020 Rule.

The Agency recognizes the importance of off-reservation water rights. However, expanding
the definition of "neighboring jurisdiction" to include non-TAS Tribes is not supported by
the statutory text in section 401(a)(2). Section 401(a)(2) applies to "any other state." CWA

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section 518(e) authorizes EPA to treat eligible Tribes with reservations in a similar manner
as a state for purposes of section 401. Neither section 518(e) nor section 401 authorize EPA
to treat non-TAS tribes as a state for purposes of section 401(a)(2).

11.1.4 Scope of the Neighboring Jurisdiction Process

One commenter asserted that the scope of section 401(a)(2) is the same as section 401(a)(1), because
section 401(a)(2) is inextricably linked to section 401(a)(1), noting the word "such" refers to the scope of
discharges provided in section 401(a)(1). The commenter suggested that to the extent proposed section
121.13 (a) reflects a narrower view, EPA should modify the regulation to ensure it reflects that section
401(a)(2) applies to "any discharge" that "may result" from any federally licensed or permitted activity.

Agency's Response: The neighboring jurisdictions process established in section 401(a)(2) is
distinct from the process for certification, which is a prior step in the statutory regime.
Whereas the text of section 401(a)(1) and section 401(d) refers to a "certification" of
compliance with water quality requirements, the text of section 401(a)(2) does not refer to
the actions taken by the Administrator or a neighboring jurisdiction as "certifications."
Instead, the text of section 401(a)(2) is clear that the neighboring jurisdictions process is
distinct from, and follows after, a "certification" made pursuant to section 401(a)(1) and
section 401(d). EPA rejects the assertion that the scope of the neighboring jurisdictions
process in section 401(a)(2) must be the same as the scope of certification, as there are
different statutory provisions relating to certification and the neighboring jurisdictions
process, and interpreting them the same would not be consistent with the language of these
distinct statutory provisions. Section 401(d), which is key to EPA's conclusion regarding
scope of certification, applies only to certification and not to the neighboring jurisdictions
process established in section 401(a)(2). Likewise, the Supreme Court's reasoning in PUD
No. 1 regarding the proper scope of certification (which EPA agrees with) does not extend
to the neighboring jurisdictions process in section 401(a)(2).

In contrast to statutory language pertaining to certification, which supports a broader
scope, the text of section 401(a)(2) establishes that the Administrator and notified
neighboring jurisdictions consider the potential discharges of the project. Specifically,
pursuant to section 401(a)(2) the Administrator considers whether "such a discharge" may
affect the water quality of a neighboring jurisdiction, and likewise, a notified neighboring
jurisdiction considers whether "such discharge" will affect its water quality so as to violate
water quality requirements. EPA interprets this language as limiting the neighboring
jurisdictions process to discharges from the project.

In response to the commenter asserting that the scope of section 401(a)(2) is inextricably
linked to section 401(a)(1) through the use of the word "such", EPA disagrees. While EPA
agrees that the "such" language employed in section 401(a)(2) refers to discharges from
"any activity" subject to certification pursuant to section 401(a)(1), the Agency does not
conclude that section 401(a)(1) compels the scope of the neighboring jurisdictions process to
be the same as the scope of certification. As discussed in the final rule preamble, the scope

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of certification is based, in part, upon statutory text within both section 401(a)(1) and
section 401(d), and nothing in either of these statutory provisions or section 401(a)(2)
compels the neighboring jurisdictions process to have the same scope as certification. This
interpretation is also consistent with the legislative history regarding the neighboring
jurisdictions process in CWA section 401, and its predecessor section 21(b) of the Water
Quality Improvement Act of 1970. The text of section 21(b)(2) in the Water Quality
Improvement Act of 1970 also reflected the "such a discharge" and "such discharge"
language later employed in section 401(a)(2), before the 1972 amendments changed the
language in section 21(b)(1) from "such activity" to "such discharge" in CWA section
401(a)(1). The fact that the "discharge" language in section 401(a)(2) remained consistent
throughout amendments supports that Congress intended the scope of the neighboring
jurisdictions process to consider "discharges," and it adopted and maintained a statutory
regime with differing scopes for certification and the neighboring jurisdictions process.

EPA's interpretation of the scope of the neighboring jurisdictions process is further
supported by procedural differences between this process and certification. Several
procedural differences reflect a more limited authority for notified neighboring
jurisdictions than that of certifying authorities. As discussed further below, neighboring
jurisdictions only receive notification under section 401(a)(2) when EPA determines that a
discharge from the project may affect their water quality, unlike section 401(a)(1)
certification where the project proponent for the Federal license or permit must request
certification from the certifying authority regardless of the known or suspected potential
impacts to water quality. Likewise, notified neighboring jurisdictions determine whether
discharge from the project will affect the quality of their waters so as to violate any water
quality requirements, a standard inverse to that of a certifying authority determining if it
can certify compliance with water quality requirements pursuant to section 401(a)(1). This
distinction matters because the neighboring jurisdiction must make an affirmative case to
support a "will affect" determination, a higher bar than that of a certifying authority,
which could deny certification because of a lack of information supporting a conclusion that
the activity will comply with water quality requirements. Additionally, in contrast to the
certification decision made by the certifying authority, the outcome of the neighboring
jurisdictions process following a hearing is determined by the Federal licensing or
permitting agency, based upon the recommendations of the neighboring jurisdiction and
EPA, and any additional information presented at the hearing. Taken together, these
procedural distinctions reflect a more limited authority for notified neighboring
jurisdictions in the neighboring jurisdictions process than the role of a certifying
authorities, which supports EPA's interpretation finding a more limited scope for the
neighboring jurisdictions process.

In addition to the differences between the extent of authority of a notified neighboring
jurisdiction and a certifying authority, the statutory text of section 401 also reflects
differences in the timing of the neighboring jurisdictions process compared to the timing of
certification, which likewise support EPA's interpretation of differing scopes for these steps.
In the neighboring jurisdictions process, both EPA and notified neighboring jurisdictions

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are provided less time to make determinations regarding the water quality effects to a
neighboring jurisdiction (30 days and 60 days, respectively) than a certifying authority has
for acting on a request for certification (up to a year). The difference in the timing of
determinations at these steps supports differing scopes, as it may be possible for EPA and
notified neighboring jurisdictions to complete determinations in the more limited time
provided for in the neighboring jurisdictions process based upon a more discrete analysis
focused on discharges.

11.2 Initiating the Neighboring Jurisdiction Process

11.2.1 Triggers for (a)(2) process

Several commenters provided input on the proposed approach to have a waiver trigger the section
401(a)(2) process. A few commenters agreed that a waiver should trigger the section 401(a)(2) process
and asserted that it would improve the neighboring jurisdiction process. Conversely, a few other
commenters argued that a waiver should not trigger the section 401(a)(2) process and asserted that there
is no statutory basis for the inclusion of waivers. One of these commenters added that expanding the
notification process beyond what the statute provides would lead to needless process and delays.

Several commenters also provided input on what a Federal agency must receive prior to notifying EPA
pursuant to section 401(a)(2). One commenter asserted that a Federal agency must notify the
Administrator only when it has received both an application for a license or a permit and the certification
request, while another commenter argued that requiring the Federal agency to be in receipt of both the
application and certification before notifying EPA would increase delays. Conversely, one commenter
agreed that section 401(a)(2) may only be initiated upon the Federal agency's receipt of the Federal
license or permit application and either a certification or waiver. The commenter noted that this
clarification will ensure that EPA and neighboring jurisdictions have necessary information to make
determinations, asserting that inconsistent information sharing between the Federal agency and EPA has
led to confusion and information gaps in the past.

One commenter asserted that EPA should not require the Federal agency to have a draft license or permit
when it notifies EPA under the neighboring jurisdiction process, while another commenter asserted that
the draft permit should be included for making the "may affect" determination if the draft permit is to be
provided before making a certification decision.

Agency's Response: EPA disagrees with the assertion that the statute does not support
waiver initiating the neighboring jurisdictions process established in section 401(a)(2). As
explained in the final rule preamble, EPA is interpreting waiver of certification as a
substitute for a grant of certification for purposes of section 401(a)(2) based upon the
purpose of this statutory provision.6 Employing a more restrictive interpretation would

6 In fact, the language in section 401(a)(1) describes waivers of certification as a substitute for a granted
certification because the Federal licensing or permitting agency is unable to proceed with their licensing
or permitting process "until the certification required by [section 401(a)(1)] has been obtained or has been

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otherwise allow certifying authorities to circumvent the neighboring jurisdictions process
by waiving certification on projects affecting the water quality of neighboring jurisdictions,
which is counter to the purpose of the process established in section 401(a)(2). Additionally,
EPA also does not agree that this interpretation will result in unnecessary delays for
Federal licensing or permitting because the statute limits the time EPA and the notified
neighboring jurisdiction have to respond to a notification (30 days and 60 days,
respectively). Further, as the process established by section 401(a)(2) provides an important
mechanism for notified neighboring jurisdictions to meaningfully engage with Federal
agencies on objections where they find a discharge from a project will violate their water
quality requirements, EPA does not find this approach results in unreasonable process.

EPA disagrees that notification provided by a Federal agency prior to receipt of
certification satisfies the notification requirement in section 401(a)(2), as this is inconsistent
with the statutory language, which provides that the Federal agency shall provide
notification "[u]pon receipt of such application and certification." As a result, notification
prior to receipt of certification or waiver would not be sufficient to satisfy a Federal
agency's obligation pursuant to section 401(a)(2). Furthermore, EPA disagrees that
notification after a Federal agency receives a certification decision will increase delays in
the Federal licensing or permitting process. Rather, a certification decision may render the
need to notify EPA under section 401(a)(2) moot (i.e., denial) or it may inform EPA's
analysis for its "may affect" determination and make it unnecessary to make a "may affect"
finding (i.e., a certification with conditions).

This final rule does not require a Federal agency to provide a copy of the draft license or
permit in its notification to EPA pursuant to section 401(a)(2). However, EPA recognizes
that with respect to general Federal licenses and permits, there is no formal "application,"
and for that reason acknowledges that Federal agencies may provide a draft Federal license
or permit in notification to EPA pursuant to section 401(a)(2).

11.2.2 Timing for Federal Agency to notify EPA

Several commenters provided input on the proposed interpretation of "immediately" in section 401(a)(2).
A few commenters asserted that five days is adequate and satisfies the statutory requirement of
"immediately." Conversely, another commenter asserted that providing Federal agencies with five
calendar days to notify EPA of the receipt of a 401 certification to start the neighboring jurisdiction
process is an unrealistic timeframe, and asked EPA to consider interpreting "immediately" as five
business days or 10 calendar days.

One commenter stated that it is not clear if there are consequences for the Federal agency failing to meet
the five-day deadline.

waived." 33 U.S.C. 1341(a)(1). By listing the two scenarios under which the process continues, it is
reasonable to consider a waiver of certification as a substitute for a certification.

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Agency's Response: EPA agrees with commenters that five days is adequate and is
finalizing its proposed interpretation of "immediately" to mean within five calendar days of
the Federal agency's receipt of the application for a Federal license or permit and either
receipt of certification or waiver. EPA disagrees that the five-day period is unrealistic. EPA
did not encounter significant challenges in implementing this interpretation in the 2020
Rule. The Agency finds five days a prompt yet reasonable amount of time for Federal
agencies to complete notification to EPA pursuant to section 401(a)(2). This interpretation
reflects the urgency connotated in the statutory language of section 401(a)(2), while also
recognizing that the Federal agency needs some amount of time to process receipt of the
Federal license or permit application and certification or waiver from the project proponent
or certifying authority, and then transmit notice to the appropriate EPA regional office.
Additionally, EPA finds that this approach provides clarity to Federal agencies regarding
the timing of notification to EPA pursuant to section 401(a)(2), and also ensures consistency
in practices across Federal licensing and permitting agencies.

The Agency notes that a Federal agency's failure to notify EPA within five calendar days of
receipt of the application and certification or waiver would not comply with this final rule.
Nevertheless, even if a Federal agency notifies EPA after five calendar days, EPA is still
entitled to a 30-day period to make its "may affect" determination, and the neighboring
jurisdictions process must conclude before a Federal agency issues a license or permit.

11.2.3 Contents of Federal Agency notification to EPA

One commenter said that the Federal agency should not be required to provide EPA with any information
other than the certification or waiver of certification and the Federal license or permit application because
it would exceed EPA's authority under section 401(a)(2) and place excess burden on the Federal agency
and the applicant. The commenter further asserted that if the final rule includes supplemental information
requirements for section 401(a)(2) notification, then it should be limited to existing information that is
readily available.

Agency's Response: EPA disagrees that the provision in section 121.12(b) of the final rule
allowing the Regional Administrator to request supplemental information where needed to
make a "may affect" determination exceeds the Agency's statutory authority pursuant to
section 401(a)(2). The statutory text of section 401(a)(2) does not preclude the Agency from
seeking supplemental information in such circumstances, and otherwise does not limit what
information the Agency considers in making a "may affect" determination. See 33 U.S.C.
1341(a)(2). Additionally, the Agency finds that as a practical matter, it is both reasonable
and in the best interests of the Federal licensing or permitting agency and the project
proponent for the Agency to have adequate information to inform its "may affect"
determination. Although EPA is not creating formalized strictures on the supplemental
information the Regional Administrator may request pursuant to section 121.12(b) of the
final rule, given the uncertainty of addressing unknown circumstances necessitating such
supplemental information, it generally anticipates that such supplemental information
would be information readily available to the Federal agency or project proponent. The

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Agency included discussion of readily materials in section 3.1.3.2 above and in final rule
preamble section IV.C.2.

11.2.4 Individual versus General Permits/Licenses

One commenter asked EPA to clarify how general permits, as opposed to individual permits, are treated
under the neighboring jurisdiction process. Another commenter asserted that EPA should consider only
requiring the neighboring jurisdiction process for larger, complex individual permit projects because of
wide-ranging implications of the neighboring jurisdiction process.

Agency's Response: The Agency wishes to reiterate that all certifications or waivers will
trigger the neighboring jurisdictions process, including general permits. EPA finds no basis
in the statutory text supporting an exception to this process for general permits or less
complex individual permits. Instead, the type of project and discharge covered in the
Federal license or permit are factors that may be considered by EPA and any notified
neighboring jurisdictions in their determinations regarding the water quality effects of a
discharge from a project in the neighboring jurisdictions process.

The Agency is aware that there are instances where a Federal license or permit application
does not accompany a certification or waiver (e.g., certification on general permits or Corps
civil works projects). Again, certifications or waivers on those projects are not exempt from
the neighboring jurisdictions process. Rather, EPA expects Federal agencies to determine
how best to comply with all section 401 requirements. For example, on a Corps civil works
project, compliance may involve the Corps sending a project study in conjunction with a
certification or a waiver of certification.

11.3 "May Affect" Determination

11.3.1 Whether EPA is Required to Make a "May Affect" Determination

Commenters were divided on whether EPA is required to make a "may affect" determination under
section 401. Some commenters asserted that section 401 provides EPA discretion whether to make a
"may affect" determination, and that EPA need not make this determination with regard to all licenses or
permits subject to section 401. Some of these commenters asserted additional rationales for this position,
including that requiring EPA to make a "may affect" determination for all licenses or permits subject to
section 401 would be an inefficient use of EPA resources and result in unnecessary delays in the licensing
or permitting process. One commenter asserted that neighboring jurisdiction review is unnecessary in
many cases where projects appear sufficiently distanced from the border of a neighboring jurisdiction and
would result in lengthy and unnecessary delays for project proponents. Accordingly, the commenter
recommended that the proposed rule should be revised to allow EPA greater discretion in subjecting
projects to review under proposed section 121.12. The same commenter also supported the use of
programmatic agreements between EPA and Federal agencies to reduce the number of routine projects
distant from a neighboring jurisdiction border subject to neighboring jurisdiction coordination, arguing
that it would provide a more efficient and timely authorization for the regulated public.

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Some other commenters agreed with the language in the proposal stating that section 401 requires EPA to
make a "may affect" determination upon receiving notice from the licensing or permitting Federal
agency. Some such commenters referenced the case cited in the proposal, Fond du Lac Band of Lake
Superior Chippewa v. Wheeler, 519 F. Supp. 3d 549 (D. Minn. 2021). Additionally, some of the
commenters supporting the position that EPA is required to make "may affect" determinations noted that
this approach better allows neighboring jurisdictions to protect their water quality and provides
transparency.

Agency's Response: EPA finds that the statutory language in section 401(a)(2) provides
EPA discretion when making a "may affect" determination. However, the Agency does not
agree that the statutory text provides EPA with discretion to decide that the Agency will not
make a may affect determination following appropriate notification from the Federal
agency. As noted by the court in Fond du Lac, this interpretation would be inconsistent with
the statutory text of section 401(a)(2) directing the Agency to provide notification within a
set timeframe to a neighboring jurisdiction when it finds that a discharge from a project
may affect its water quality. See Fond du Lac, 519 F.Supp.3d at 563 (noting that it would be
odd "if a decisionmaker ... was mandated by law to do everything that was necessary to
make a particular type of decision ... but was not mandated by law to actually make the
decision."). Given the Agency's interpretation that it is required to make a "may affect"
determination upon appropriate notification from the Federal licensing or permitting
agency pursuant to section 401(a)(2), the Agency finds that use of resources for this purpose
is necessary to comply with the statute. Finally, the Agency rejects the argument that
making "may affect" determinations in accordance with section 121.13(a) of the final rule
will add unnecessary delays to the Federal licensing or permitting process, as the Agency is
finding that it is required to make a "may affect" determination pursuant to section
401(a)(2), and the statutory text provides a set, relatively short, timeframe for the Agency to
make this determination (30 days). See 33 U.S.C. 1341(a)(2).

EPA disagrees with commenter suggesting that certain projects should be exempt from the
neighboring jurisdictions process. Rather, section 401(a)(2) provides that all certifications
or waivers will trigger the neighboring jurisdictions process, regardless of the project's
distance from the border of a neighboring jurisdiction. EPA finds no basis in the statutory
text supporting an exception to this process based on distance. Instead, the proximity of the
project and discharge to neighboring jurisdictions is one factor that may be considered by
EPA and any notified neighboring jurisdictions in their determinations regarding the water
quality effects of a discharge from a project in the neighboring jurisdictions process.

11.3.2 Clarifying the "May Affect" Standard

Commenters asserted differing interpretations of the meaning of the "may affect" standard. A commenter
argued that this standard examines the likelihood of whether a discharge will cause a downstream
violation of federal, state, or Tribal requirements adopted pursuant to authority under sections 301, 302,

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303, 306, and 307 of the CWA. Another commenter proposed that EPA require an actual demonstration
that there may be an effect to find this standard met.

In contrast, another commenter asserted that EPA should determine the standard would be met where
some reasonable possibility for an effect exists, even where EPA does not have conclusive evidence of
such effect. Still another commenter asserted that the standard simply requires an analysis of whether the
discharge has the possibility of affecting a neighboring jurisdiction's water quality, that this standard
encompasses both beneficial and adverse effects, and that it is a low threshold. This commenter requested
that EPA specifically clarify that this standard is a low threshold.

Agency's Response: EPA is not further defining the meaning of "may affect" in section
401(a)(2), aside from identifying factors that it may consider in making a "may affect"
determination, as the statutory language provides sufficient clarity that this standard is met
"[wjhenever such a discharge may affect, as determined by the Administrator, the quality
of the waters" of a neighboring jurisdiction. 33 U.S.C. 1341(a)(2). This standard is
necessarily broadly applicable, as it must be applied to differing Federal licenses and
permits in a wide range of factual circumstances. Moreover, section 401(a)(2) recognizes the
Administrator's discretion applying this standard in a "may affect" determination.

Although EPA is not attempting to further define the "may affect" standard in the final
rule, it notes that this standard is distinguishable from the standard that notified
neighboring jurisdictions apply to make a determination regarding an objection, which is
whether "such discharge will affect the quality of its waters so as to violate any water
quality requirements" in its jurisdiction. See 33 U.S.C. 1341(a)(2). Unlike the standard
applied by notified neighboring jurisdictions in making a determination regarding an
objection, the standard applied by EPA in its "may affect" analysis does not require
consideration of whether water quality effects of discharge from the project will result in
violation of water quality requirements. Instead, the standard applied by EPA in its "may
affect" determination only requires analysis of whether discharge from the project may
have water quality effects on a neighboring jurisdiction. Additionally, the "may affect"
standard, in contrast to the standard applied by notified neighboring jurisdictions, does not
require a finding that the discharge "will" effect water quality. Accordingly, EPA finds this
standard may be met where there may be an effect to a neighboring jurisdiction's water
quality, but such effect is not certain to occur.

11.3.3 Consultation on "May Affect" Determinations

Some commenters also expressed views with regard to the role of neighboring jurisdictions or
stakeholders more broadly in EPA's "may affect" determination. Some commenters suggested that EPA
consult with or involve neighboring jurisdictions in making "may affect" determinations. Likewise, some
of these commenters more specifically asserted that EPA should consult with Tribal neighboring
jurisdictions in making "may affect" determinations. One such commenter requested that EPA codify a
Tribal consultation requirement and commit to engaging potentially affected Tribes in making "may
affect" determinations. Another commenter asserted that placing the "may affect" determination solely

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within the purview of the Administrator would risk ignoring important information from neighboring
Tribal jurisdictions that might inform EPA's determination. Although the commenter acknowledged the
proposal's requirement that Federal agency notifications include whether the neighboring jurisdiction
expressed concerns or provided comments on the project, the commenter stated that there may still be
instances where a neighboring Tribe will not be informed by the Federal agency of a pending license or
permit or does not have the resources to monitor or comment on every license or permit. The commenter
further argued that without a process to ensure Tribal neighboring jurisdictions' views are sought and
considered, EPA may make a "may affect" determination without considering impacts on Tribes and their
reserved rights.

Additionally, a commenter argued that it was appropriate and reasonable for EPA to solicit input from the
project proponent and Federal licensing or permitting agency in the process of making a "may affect"
determination.

Agency's Response: EPA finds its position regarding its sole discretion in making a "may
affect" determination and the role of stakeholders, including neighboring jurisdictions, in
such a determination is reasonable and consistent with the statutory text of section
401(a)(2). Section 401(a)(2) specifically recognizes EPA's discretion in making a "may
affect" determination, and does not establish a role for stakeholders in EPA's
determination. Further, section 401(a)(2) provides EPA with only 30 days to make a "may
affect" notification and provide any required notification to neighboring jurisdictions. EPA
does not find the limited period of time that the statute affords the Agency for its "may
affect" determination and any required notification consistent with a process in which it
engages stakeholders and solicits their input, and imposing such a process would burden the
Agency. Accordingly, EPA declines to adopt such a process for "may affect"
determinations.

Although EPA is not adopting a process to engage stakeholders and solicit their input in
making "may affect" determinations, the Agency wishes to emphasize that it may consider
factors relevant to the neighboring jurisdiction in making a "may affect" determination.
For example, the Agency may consider various factors in making its "may affect"
determination, such as the neighboring jurisdiction's water quality requirements and the
views of the neighboring jurisdiction on the effect of discharge from the project on its water
quality.

11.3.4 Factors Considered by EPA in Making a "May Affect" Determination

Most commenters addressing factors for EPA to consider in "may affect" determinations supported EPA
providing some identification of such factors in the final rule. Such commenters noted that identification
of factors clarifies and provides broader understanding of the EPA's process in making a "may affect"
determination and may improve efficiency in making this determination. Some commenters agreed that
EPA has discretion in making a "may affect" determination, but asserted that this discretion is not
unbounded, arguing that EPA is limited by the statutory bounds of section 401.

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Some commenters recommended that EPA establish an exclusive list of factors it considers in making
"may affect" determinations, limiting the factors considered in each determination to only those identified
on this list. Collectively, these commenters asserted that this approach would limit subjectivity in such
determinations, increase predictability, allow Federal agencies and project proponents to plan, and would
focus the determinations and possible subsequent proceedings by Federal agencies on non-speculative
assertions of impacts to water quality. A few commenters asserted that the proposed rule did not provide
sufficient detail to make the Section 401(a)(2) process clear, predictable, or transparent because there are
no substantive criteria to ascertain how EPA makes a "may affect" determination.

Some other commenters supported EPA codifying a list of factors it must consider in making a "may
affect" determination, but providing that EPA may consider other factors. A commenter argued that this
approach is supported by the fact that there are certain factors that are relevant to all circumstances.
Another commenter asserted that this would allow EPA to establish a minimum standard for what it
considers in "may affect" determinations.

Additionally, some other commenters supported EPA identifying examples of considerations to improve
clarity but did not recommend requiring EPA to consider factors in recognition of the fact-dependent
nature of "may affect" determinations.

Many commenters supported EPA considering the factors identified in the proposal in making a "may
affect" determination, these factors included the type of the project and discharged covered in the permit,
the proximity of the project and discharge to other jurisdictions, certification and other conditions already
contained in the draft license or permit, and the neighboring jurisdiction's water quality requirements. A
commenter raised concern about EPA considering certification and other conditions already contained in
the draft license or permit as a relevant factor, stating that such conditions would not eliminate the
possibility of effects to a neighboring jurisdiction, and asserting that a more relevant factor is the types of
conditions typically included in the neighboring jurisdiction's certifications and permits.

Some commenters suggested other factors as relevant for EPA to consider in its "may affect"
determination, including the water quality and characteristics of the water receiving the discharge; other
discharges to the receiving water; uses of the receiving water (including Tribal, subsistence, and unique
uses); Tribal treaty rights; concerns and interests of the neighboring jurisdiction; environmental justice;
climate change factors; and health and safety concerns.

Agency's Response: As discussed in Section IV.K of the final rule preamble, EPA is
finalizing the proposed approach to identify factors that EPA may consider in making a
"may affect" determination and is not establishing specific factors that EPA must analyze in
making a "may affect" determination. EPA is also reiterating the factors that it identified in
the preamble of its proposal as factors it may consider in making a "may affect"
determination.

EPA agrees that its discretion regarding making a "may affect" determination is bounded
by the statutory grant of authority in section 401. When EPA conducts its "may affect"
analysis, EPA considers whether discharge from a project may affect the water quality of a

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neighboring jurisdiction, in accordance with the statutory language of section 401(a)(2).
Thus, EPA is declining to adopt commenter suggestions to consider or identify factors that
are not tailored to this analysis of water quality effects.

EPA disagrees with the approaches suggested by certain commenters that EPA identify
either an exclusive list of factors for the Agency to consider in making this determination, or
establish a minimum list of factors that EPA must consider, as these approaches do not
recognize the fact-dependent nature of a "may affect" determination and do not provide the
flexibility necessary for the Agency to make "may affect" determinations involving different
types of licenses and permits. Identifying an exclusive list of factors for the Agency to
consider in making a "may affect" determination could preclude the Agency from
considering important information relevant to determining whether discharge from a
project may affect the water quality of a neighboring jurisdiction. Additionally, this
approach does not appear to be consistent with the statutory language in section 401(a)(2),
which does not impose limitations on the information the Agency may consider in making
this determination, but rather recognizes the Agency's discretion in making this
determination. Likewise, establishing a minimum list of factors that EPA must consider in a
"may affect" determination could require the Agency to consider factors even where they
are not relevant to determining whether discharge may affect the water quality of a
neighboring jurisdiction. This approach would not prove efficient, which is of particular
concern as the Agency is only afforded 30 days to make a "may affect" determination and
provide any required "may affect" notification. Instead, the Agency finds that identifying
examples of factors that it may consider in making a "may affect" determination, as it has
above, provides greater clarity without inappropriately limiting the Agency from
considering other relevant factors or requiring it to apply factors where they are irrelevant.

In response to commenters' suggestions, EPA is identifying the current water quality and
characteristics of the water receiving the discharge as factors it may consider in its "may
affect" analysis, in addition to the factors previously identified at proposal. EPA finds these
to be reasonable inclusions in the examples of factors it may consider in a "may affect"
determination, and, as a result, is identifying these factors in the final rule preamble.
However, EPA is declining to identify factors which appear to be already addressed by
those identified at proposal or factors which relate only to specific factual circumstances for
purposes of avoiding repetition or confusion. See Section IV.K of the final rule preamble for
a non-exhaustive list of factors that the Agency may consider in making a "may affect"
determination.

11.3.5 Other Procedural Recommendations

Some commenters offered procedural recommendations for EPA to adopt regarding its "may affect"
determinations. A commenter argued that 30 days is too long of a period for EPA to make "may affect"
determinations, and suggested EPA limit the period of time to complete these determinations to 15 days.
Another commenter stated that general permits do not provide sufficient information for EPA to
determine potential water quality impacts to a neighboring jurisdiction and requested that EPA use

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information contained in the permit application to make its "may affect" determination for activities
authorized under general permits. One commenter recommended that EPA should define a reasonable
minimum period of time for the EPA to notify both the Federal and permitting agency and certifying
authority from the date an individual certification is issued.

A few commenters expressed concern that EPA is not required to provide a response when not finding
that a discharge may affect the water quality of a neighboring jurisdiction and suggested that lack of a
response could have meaning other than this finding. One of these commenters argued that the
neighboring jurisdiction may not agree with EPA that there is no impact but would not know about the
proposed project without EPA's notice. Similarly, another commenter recommended that EPA publish its
"may affect" determinations in the Federal Register, so Tribes may access this information, including in
instances where EPA has not determined that a discharge will affect a neighboring jurisdiction's waters.
One commenter said that EPA should notify neighboring jurisdictions when EPA determines that an
activity does not have the potential to affect water quality to show that EPA carried out its role under
section 401(a)(2). Another commenter suggested that EPA should revise proposed section 121.13(b) to
provide notice to a neighboring jurisdiction within 5 days of determining that an activity does not have
the potential to affect the water quality of a neighboring jurisdiction. The same commenter asserted that
the notification should include the reason for reaching a negative decision, arguing that a notification is
essential to show that EPA carried out the required assessment and to provide transparency to all
interested parties as to how EPA arrived at its determination. One commenter recommended that EPA
should provide notification to a neighboring jurisdiction for any projects that discharge into
transboundary or shared waterways to allow certifying authorities to analyze any potential impact to their
waters.

One commenter argued that the Agency should address the information EPA must provide to states and
develop operating procedures with states to ensure effective implementation of section 401(a)(2). The
commenter asserted that such involvement is important in their jurisdiction because of its investment in
the Chesapeake Bay TMDL requirements and that it may aid environmental justice efforts. The
commenter suggested that Federal agencies, the Regional Administrator, and certifying authorities work
collaboratively to pre-identify locations, resources, or activity thresholds of concern, and establish an
earlier process to address concerns before a permit or license is issued.

Agency's Response: As discussed in the final rule preamble, the statute provides EPA with a
30-day period to make a "may affect" determination and provide any required notification,
and EPA declines to shorten the time period for the Agency to take such actions. EPA notes
that the 2020 Rule also provided a 30-day time period for the Agency to perform these
actions, and EPA did not find that this approach resulted in unnecessary Federal licensing
or permitting delays. Accordingly, the Agency finds it reasonable to retain the 30-day time
period reflected in statute for making a "may affect" determination and providing any
required notification.

The Agency also declines to adopt commenter suggestions to start EPA's time period to
conduct a "may affect" determination analysis from the date a certification is issued. As
discussed in Section IV.K of the final rule preamble, section 401(a)(2) requires a Federal

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agency to "immediately" notify EPA when it receives a Federal license or permit
application and a certification or waiver. EPA's 30-day period to determine whether
discharge may affect the water quality of a neighboring jurisdiction may only begin once it
is notified by the Federal agency in accordance with section 401(a)(2) and this final rule. See
Section IV.K of the final rule preamble for further discussion on the contents of a Federal
agency's notification to EPA.

In response to the comment regarding the contents of a notification for a general permit, the
Agency wishes to reiterate that the contents of a Federal agency's notification to EPA
defined at section 121.12 of this final rule apply to all certifications and waivers, including
certifications and waivers on general licenses or permits. As discussed in Section IV.K of the
final rule preamble, the Agency is aware that there are instances where a Federal license or
permit application does not accompany a certification or waiver (e.g., certification on
general permits or Corps civil works projects). Certifications or waivers on those projects
are not exempt from the neighboring jurisdictions process. Rather, EPA expects Federal
agencies to determine how best to comply with all section 401 requirements. For example,
on a project that obtained certification for authorization under a general permit,
compliance may involve the Federal agency sending the PCN in conjunction with a
certification or waiver of certification.

In consideration of the statutory constraints on EPA to make a "may affect" determination
and provide "may affect" notification within 30 days of proper notice from the Federal
agency, EPA is not expanding the notification requirements beyond the circumstances and
to the parties it is required to provide such notification pursuant to section 401(a)(2). The
neighboring jurisdictions process established in section 401(a)(2) does not direct the EPA to
provide notification outside of circumstances in which the Agency has determined that a
discharge from the project may affect a neighboring jurisdiction's water quality. Likewise,
the statutory language does not provide for "may affect" notification to other parties
besides the relevant neighboring jurisdiction, the Federal agency, and the project
proponent. See 33 U.S.C. 1341(a)(2). Accordingly, the statutory language reflects a more
limited process for the Agency to provide "may affect" notification than suggested by
certain commenters, which is consistent with the limited duration of time afforded the
Agency for making a "may affect" determination and providing such notification in section
401(a)(2). Given the limited 30-day period for Agency action in this context, and in
consideration of the overall volume of "may affect" determinations made by the Agency,
EPA finds it reasonable to maintain the notification requirements established in the
statutory text of section 401(a)(2), and is not expanding these requirements beyond the
statutory bounds.

Section 401(a)(2) also does not provide the specific manner in which the Agency must
provide notification when it has determined that a discharge from the project may affect a
neighboring jurisdiction's water quality. The Agency declines to adopt commenter
suggestions to publish all "may affect" determinations in the Federal Register because of
the limited duration of time afforded the Agency for making a "may affect" determination

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and providing such notification in section 401(a)(2). As provided in section 121.13(b) of the
final rule, the Agency will provide the neighboring jurisdiction, Federal agency, and project
proponent with notice in accordance with section 121.13(c). The Agency finds this approach
will ensure relevant stakeholders are notified in a timely manner consistent with section
401(a)(2).

As discussed in the preambles to the proposed rule and the final rule, the Agency is not
identifying specific factors EPA must analyze in making a "may affect" determination,
given the range of Federal licenses or permits that are covered by CWA section 401(a)(2)
and EPA's discretion to look at various factors. 87 FR 35368; Section IV.K of the final rule
preamble. The Agency notes that each "may affect" determination is likely to be fact-
dependent and based on situation-specific circumstances and expressed uncertainty that it
could provide a required list of factors for it to consider in making a "may affect"
determination. The Agency is maintaining its position that it has sole discretion, pursuant to
section 401(a)(2), to examine the facts and determine whether the discharge "may affect"
the quality of a neighboring jurisdiction's waters. This interpretation regarding the
Agency's discretion is consistent with the statutory language of section 401(a)(2), which
directs EPA to notify neighboring jurisdictions "[wjhenever such a discharge may affect, as
determined by the Administrator...." 33 U.S.C. 1341(a)(2) (emphasis added). The Agency is
further maintaining its position that EPA is not required to engage with stakeholders or
seek their input in making a "may affect" determination. However, the Agency may
consider the neighboring jurisdiction's views on the effect of a discharge from the project
on its water quality as a factor in making a "may affect" determination. Further, in section
121.12(a) of the final rule, EPA is finalizing the proposed regulatory text defining the
contents of a Federal agency's notification to EPA to include an indication of whether any
neighboring jurisdictions have expressed water quality concerns or provided such comment
on the project. This provision may increase EPA's awareness of water quality concerns
raised by neighboring jurisdictions at the time the Agency receives notice prompting it to
make a "may affect" determination, and EPA reiterates its intention to consider such views
of neighboring jurisdictions if provided in a timely manner. See Section IV.K of the final
rule preamble for further discussion on the Agency's may affect determination; see also the
Agency's Response to Comments in Section 11.3.3 and 11.3.4.

11.4 Neighboring Jurisdiction's Role

11.4.1 General

A commenter asserted that requiring a Tribal neighboring jurisdiction to explain its reasons for opposing
certification with an expectation that it will cite to its water quality requirements would continue the 2020
Rule's content requirements, which the commenter argued the preamble otherwise says it is rejecting. The
commenter further explained that the proposed rule's approach to the neighboring jurisdiction's objection
may be more burdensome than the 2020 Rule and injects uncertainty into the process (i.e., using
"including but not limited to" language to describe requisite contents). Instead, the commenter
recommended that the Agency remain silent on this issue like the 1971 Rule so that neighboring

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jurisdictions have discretion to determine what information to include. The same commenter also rejected
inclusion of certification conditions in the objection. Alternatively, the commenter recommended that
EPA could include discretionary language at section 121.14 and develop guidance materials that indicate
the types of evidence and information that would be helpful for the neighboring jurisdiction to include in
its objection and/or prior to the public hearing for EPA to consider in its evaluation and recommendation.
The commenter also stated that EPA could include discretionary language requesting conditions that the
neighboring jurisdiction believes could resolve the objection, or else a statement that no condition can
ensure compliance with applicable water quality requirements. Lastly, the commenter recommended that
EPA should establish a Tribal consultation process to gather information from an objecting Tribe before
the public hearing to have for development of EPA's evaluation and recommendation.

A few commenters asserted that the project proponent, as opposed to the neighboring jurisdiction, has the
burden to show a license or permit should be issued. One of these commenters said that the permit
applicant, not the neighboring jurisdiction, should have the burden or responsibility of proving that the
permit should be issued, because the applicant and the Federal agency are responsible for ensuring
compliance with the affected state's water quality requirements. Another of these commenters said that
the Supreme Court has construed section 401(a)(2) to "prohibit the issuance of any federal license or
permit over the objection of an affected State unless compliance with the affected State's water quality
requirements can be ensured." Arkansas v. Oklahoma, 503 U.S. 91, 103 (1992). The commenter said that
section 401 is a regulatory process triggered by an applicant that seeks a Federal license or permit and
section 401(a)(2)'s purpose is to ensure compliance with a neighboring jurisdiction's water quality
requirements. As such, the commenter argued that the applicant always has a burden of proof to show that
the permit or license should be issued and not denied. The commenter said this was exemplified when the
Tenth Circuit held that EPA erred by placing a burden of proof on a downstream jurisdiction in Oklahoma
v. EPA, 908 F.2d 595 (10th Cir. 1990), rev'd on other grounds sub nom, Arkansas v. Oklahoma, 503 U.S.
91 (1992). The commenter stated that the Tenth Circuit concluded that EPA "improperly transformed" the
permit applicant's "burden of showing the permit should be issued into a burden on Oklahoma to show
that it should be denied." 908 F.2d at 620. The commenter asserted that the statute requires the applicant
and Federal agency to overcome the objection by demonstrating that there are sufficient conditions to
"insure" such compliance. Accordingly, the commenter argued that this is the construction the Supreme
Court has placed on section 401(a)(2) by finding it "prohibit[s] the issuance of any federal license or
permit over the objection of an affected State unless compliance with the affected State's water quality
requirements can be ensured." Arkansas, 503 U.S. at 103.

A commenter recommended that EPA provide further guidance and clarity in regulatory text on the
neighboring jurisdiction review process that occurs after EPA makes a "may affect" determination. The
commenter stated that, currently, it is unclear whether comments from neighboring jurisdictions are
required to be addressed by the Federal licensing or permitting agency or by the state or Tribe that issues
the certification. Given that some states may have more stringent water quality standards than others, the
commenter said that neighboring jurisdictions should have the opportunity to incorporate certification
conditions to protect their downstream water quality.

Agency's Response: EPA does not find that section 121.14(b) is too burdensome on the

notified neighboring jurisdiction, and otherwise finds it reasonable that the notified

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neighboring jurisdiction's notification of an objection and request for hearing include an
explanation of the reasons supporting the "will violate" determination. Section 401(a)(2) of
the CWA states that a notified neighboring jurisdiction may make an objection and request
a hearing "[i]f... [the neighboring jurisdiction] determines that such discharge will affect
the quality of its waters so as to violate any water quality requirements...." 33 U.S.C.
1341(a)(2) (emphasis added). To accomplish this, the neighboring jurisdiction necessarily
must consider its water quality requirements and complete an analysis or evaluation to
determine that a discharge from the project will violate such water quality requirements.
All EPA is requiring in section 121.14(b)(2) of the final rule is that the neighboring
jurisdiction provide an explanation of that analysis or evaluation in its notification of
objection and request for hearing, including the identification of the water quality
requirements that will be violated. This will inform the Federal licensing or permitting
agency, EPA, and the project proponent of the reasoning for the objection; allow the
Federal agency and EPA to prepare for a hearing on the objection; and may assist in
determining whether there is a way to resolve the objection before the public hearing. EPA
finds this requirement is reasonable to inform the neighboring jurisdictions process and
does not find it imposes an unreasonable burden on the notified neighboring jurisdiction.

EPA observes that section 401(a)(2) only provides the notified neighboring jurisdiction, the
Federal licensing or permitting agency, and EPA with explicit roles and duties in the
neighboring jurisdictions process. CWA section 401(a)(2) requires the neighboring
jurisdiction to determine whether the discharge will violate its water quality requirements
after EPA makes a "may affect" determination, and if so, object to the issuance of the
Federal license or permit and request a public hearing. After that, if the neighboring
jurisdiction does not withdraw its objection, the Federal licensing or permitting agency
must hold a public hearing and determine whether any conditions are necessary to ensure
that the neighboring jurisdiction's water quality requirements are met. See 33 U.S.C.
1341(a)(2) ("Such Agency...shall condition such license or permit in such manner as may be
necessary to insure compliance with applicable water quality requirements.").

Section 401(a)(2) provides no specific role for the certifying authority and in fact, the
neighboring jurisdictions process occurs after the certifying authority has acted on a
request for certification. Accordingly, the certifying authority is not responsible for
addressing the neighboring jurisdiction's objection in its certification. The Federal agency
must consider the recommendations of the neighboring jurisdiction and EPA Administrator
as well as any additional evidence presented at the hearing and, based on that information,
must condition the Federal license or permit as may be necessary to ensure compliance with
applicable water quality requirements. If additional conditions cannot ensure compliance
with applicable water quality requirements, the Federal agency shall not issue the license or
permit. Additionally, section 401(a)(2) does not provide an explicit role for the project
proponent in the neighboring jurisdictions process, although the project proponent may
provide input at the public hearing. Accordingly, this final rule cannot require a project
proponent to demonstrate that a Federal license or permit should be issued through the
neighboring jurisdictions process.

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As discussed in Section IV.K of the final rule preamble, the Agency revised sections 121.13-
121.15 to more closely reflect the statutory language in section 401(a)(2) and provide greater
clarity. Accordingly, the Agency finds that sections 121.13-121.15 of the final rule provide
sufficient clarity regarding the process that occurs after EPA makes a "may affect"
determination.

11.4.2	Sending the Objection Notification to the Certifying Authority

Some commenters said that the neighboring jurisdiction should be required to send the objection
notification to the certifying authority. Conversely, another commenter said that the neighboring
jurisdiction should not be required to send the objection notification to the certifying authority because
this requirement as proposed in sections 121.13(c)(3) and 121.14(a) is contrary to section 401(a)(2). The
commenter argued that EPA identifies no statutory basis for this requirement and asserted it exceeds the
requirements expressly provided in section 401(a)(2), which provides that the neighboring jurisdiction
need only "notif[y] the Administrator and the licensing or permitting agency in writing of its objection."
The commenter went on to say that if Congress wanted to require the neighboring jurisdiction to notify
the certifying authority, Congress would have so provided. Further, the commenter said that the reason
Congress consciously chose not to require notification to the certifying authority of the "will affect"
determination is that section 401(a)(2) provides no role for the certifying authority; the matter is
exclusively among the objecting jurisdiction, EPA, and the relevant Federal licensing or permitting
agency, therefore a certifying authority has no immediate need for the "will affect" determination.

Agency's Response: EPA has eliminated the requirement that the notified neighboring
jurisdiction send the notification to the certifying authority to conform the regulatory text
more closely with the statutory language in section 401(a)(2), which does not require
notification to the certifying authority. EPA agrees that, unlike the Regional Administrator
and the Federal agency, the certifying authority does not have a specific role under CWA
section 401(a)(2). In fact, the neighboring jurisdictions process occurs after the certifying
authority has acted on a request for certification. However, like the project proponent, the
certifying authority may participate in the neighboring jurisdictions process by providing
comments during the public hearing. EPA encourages the Federal agency to involve the
certifying authority in conversations that occur prior to the public hearing, if it believes that
the certifying authority may have information that could inform discussions with the
notified neighboring jurisdiction.

11.4.3	Identifying and Justifying the Reasons for an Objection

Some commenters concurred that a neighboring jurisdiction's objection to a certification should include
identifiable and justifiable reasons supporting the determination that the discharge will violate the
neighboring jurisdiction's water quality requirements.

Alternatively, some commenters argued that EPA should not include a requirement that the neighboring
jurisdiction's objection include an explanation of the reasons supporting its determination that the

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discharge will violate its water quality requirements, including but not limited to identifying any water
quality requirements that will be violated. A commenter said EPA should withdraw its proposal to add
requirements for a neighboring jurisdiction's notification that go beyond section 401(a)(2)'s express
language. Another commenter asserted that EPA should only require a neighboring jurisdiction to lodge
its objection and request a public hearing in its notification, consistent with section 401(a)(2), which the
commenter claimed does not allude to content or form requirements for objection notifications. The
commenter argued that while proposed section 121.14(b)(1) and (3) are in line with section 401(a)(2),
proposed section 121.14(b)(2) would impose a burden that is not required under the statue. A commenter
argued that this wording invites abuse of the process by encouraging a neighboring jurisdiction to inject
issues beyond the water-quality focus of the statute generally and the notification provision in particular.
Therefore, this commenter recommended that objections be limited to claims that water quality
requirements will be violated.

Another commenter said that much of the information proposed to be required in the objection would
already be in a neighboring jurisdiction's notification. Further, the commenter argued that EPA's proposal
creates the possibility for parties to challenge a neighboring jurisdiction's objection notification simply
because it did not comply with EPA's extra-statutory requirements in regulation. For example, the
commenter said that an objecting jurisdiction could comply with section 401(a)(2)'s express requirements
but fail to satisfy the proposed requirements in the regulation to notify the certifying jurisdiction. The
commenter asserted that a party could argue the "will affect" jurisdiction is defective and of no effect for
failing to comply with the proposed regulation. Accordingly, the commenter recommended that proposed
sections 121.13(c)(3) and 121.14(a) should be revised to remove this requirement.

Agency's Response: EPA does not find that section 121.14(b) is too burdensome on the
notified neighboring jurisdiction, and otherwise finds it reasonable that the notified
neighboring jurisdiction's notification of an objection and request for hearing include an
explanation of the reasons supporting the "will violate" determination. Section 401(a)(2) of
the CWA states that a notified neighboring jurisdiction may make an objection and request
a hearing "[i]f ... [the neighboring jurisdiction] determines that such discharge will affect
the quality of its waters so as to violate any water quality requirements...." 33 U.S.C.
1341(a)(2) (emphasis added). To accomplish this, the neighboring jurisdiction necessarily
must consider its water quality requirements and complete an analysis or evaluation to
determine that a discharge from the project will violate such water quality requirements.
All EPA is requiring in section 121.14(b)(2) of the final rule is that the neighboring
jurisdiction provide an explanation of that analysis or evaluation in its notification of
objection and request for hearing, including the identification of the water quality
requirements that will be violated. This will inform the Federal licensing or permitting
agency, EPA, and the project proponent of the reasoning for the objection; allow the
Federal agency and EPA to prepare for a hearing on the objection; and may assist in
determining whether there is a way to resolve the objection before the public hearing. EPA
finds this requirement is reasonable to inform the neighboring jurisdictions process and
does not find it imposes an unreasonable burden on the notified neighboring jurisdiction.

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In response to the comment regarding notification to the certifying authority, EPA has
eliminated the requirement that the notified neighboring jurisdiction send the notification
to the certifying authority to conform the regulatory text more closely with the statutory
language in section 401(a)(2), which does not require notification to the certifying authority.
See the Agency's Response to Comments in Section 11.4.2 for further discussion.

11.4.4	Identifying Water Quality Requirements that would be Violated

Some commenters said that neighboring jurisdictions should be required to include a citation to the water
quality requirements that they believe would be violated in their objections.

Agency's Response: The Agency is declining to require the notified neighboring jurisdiction
to include a citation to the water quality requirements it believes would be violated in its
notification of objection and request for hearing. All EPA is requiring in section
121.14(b)(2) of the final rule is that the neighboring jurisdiction provide an explanation of
its analysis or evaluation for its "will violate" determination in its notification of objection
and request for hearing, including the identification of the water quality requirements that
will be violated. This will inform the Federal licensing or permitting agency, EPA, and the
project proponent of the reasoning for the objection; allow the Federal agency and EPA to
prepare for a hearing on the objection; and may assist in determining whether there is a
way to resolve the objection before the public hearing. EPA finds this requirement is
reasonable to inform the neighboring jurisdictions process and does not find it imposes an
unreasonable burden on the notified neighboring jurisdiction.

11.4.5	Identifying the "Potentially Affected" Receiving Waters

Some commenters asserted that the neighboring jurisdiction should be required to identify the "potentially
affected" receiving water. One of these commenters stated that including only the list of water quality
requirements but not the receiving body would make it impossible to determine the validity of the
concerns raised and to resolve the neighboring jurisdiction's concerns. The same commenter also asserted
that it would invite a neighboring jurisdiction to raise arbitrary concerns to slow the licensing or
permitting process.

Another commenter stated that the proposal set no boundaries for what a downstream state may consider
and does not require a downstream state to identify the body of water it anticipates will be impaired by
approval of a project, even though the entire process for a certification is initiated by determining a
discharge may affect a particular navigable water. The commenter asserted that this gives downstream
states too much authority to impose their political will on upstream states. Accordingly, the commenter
recommended that EPA devise a more focused approach that allows potentially affected downstream
states to review and respond to certifications but set parameters that require a downstream state to truly
justify any actions it proposes and to focus only on the navigable water where the discharge will occur.

Agency's Response: EPA declines to require the notified neighboring jurisdiction to
specifically identify affected receiving waters in its notification of objection and request for

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hearing. However, as EPA noted in its proposal, the Agency anticipates that this
information is likely to be included in a notified neighboring jurisdiction's explanation of
the reasons supporting its "will violate" determination, and EPA encourages neighboring
jurisdictions to include this information where possible, as it may assist the Federal agency
in evaluating the objection. As the notified neighboring jurisdiction has a limited time
period of 60-days to make its "will violate" determination and issue any notification of an
objection and request for hearing, imposing a requirement that this notification identify all
waters where discharge will violate water quality requirements may not be feasible in all
circumstances. Accordingly, EPA is not including this requirement.

The Agency also declines to limit the notified neighboring jurisdiction's focus to the
navigable water where the discharge will occur.7 While the water directly receiving
discharge from the project may be the water affected, section 401(a)(2) does not limit a
notified neighboring jurisdiction to only considering this water. Moreover, it is possible for
discharge from a project to violate water quality requirements in waters other than the
immediate receiving water and for discharge from a project to effect multiple waters in a
manner that would violate water quality requirements.

11.4.6 Identifying a Permit Condition that Would Resolve the Objection

Some commenters recommended that EPA should require the neighboring jurisdiction to identify a
license or permit condition that it thinks would resolve the objection. One commenter said that the
process would be more efficient if the neighboring jurisdiction proposes a condition, and the public
hearing testimony and comments can respond to the proposed condition. Additionally, the commenter
said that a proposed license or permit condition could help the Federal agency or agencies focus on
resolution of the objection and possibly reduce a delay in license or permit issuance. Another commenter
expressed concern that without this requirement, objections without any proposed solution could delay or
deny needed projects.

Alternatively, one commenter said that the neighboring jurisdiction should not be required to identify a
license or permit condition that it thinks would resolve the objection. The commenter stated that section
401(a)(2) ultimately contemplates two possible actions by the Federal licensing/permitting agency at the
conclusion of the section 401(a)(2) process: (1) the imposition of conditions "to insure compliance with
applicable water quality requirements," or (2) the denial of the permit or license because the "imposition
of conditions cannot insure such compliance." As such, the commenter argued that a neighboring
jurisdiction is fully within its rights to object on the basis that there are no such conditions that could
"insure" compliance and has no duty to offer conditions. Therefore, the commenter said that in cases
where the neighboring jurisdiction determines no such conditions exist, EPA's proposed requirement
would be meaningless as the neighboring jurisdiction would likely say there are no such conditions.
Further, the commenter asserted that EPA's proposed requirement also appears to place a burden on the

7 The CWA, including section 401, uses the term "navigable waters," which the statute defines as "the
waters of the United States, including the territorial seas." 33 U.S.C. 1362(7). This final rule uses the term
"waters of the United States" interchangeably with "navigable waters".

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neighboring jurisdiction to come up with a condition to resolve its objection even where the neighboring
jurisdiction believes no such condition exists.

Agency's Response: EPA is not requiring the notified neighboring jurisdiction to include
conditions with its objection notification and request for hearing; however, EPA
recommends that the neighboring jurisdiction provide Federal license or permit conditions
that will resolve the objection, if this is possible. Identifying conditions to resolve an
objection, where possible, may help inform the hearing process, and could also help resolve
an objection in advance of a hearing. In circumstances where the notified neighboring
jurisdiction does not find any conditions would resolve the objection, EPA notes that the
neighboring jurisdiction could simply state this in its objection notification and hearing
request.

11.4.7 "Will Affect" Standard

A commenter said that EPA should modify proposed section 121.14 to ensure it reflects that the "will
affect" standard includes a discharge's contributions to water quality violations, i.e., that the type of
"affect" for the "will affect" may be direct, secondary, or cumulative effects. The commenter argued that
consistent with EPA's interpretations in similar contexts, the "will affect" standard includes a discharge's
contributions to water quality violations and does not require a discharge be the sole cause, citing 54 Fed.
Reg. 23868, 23873 (June 2, 1989) (discussing the addition of "contribute to" language in NPDES
regulations because EPA does not intend "that a single point source discharge must be responsible for the
entire pollutant loading that exceeds the water quality criterion").

A commenter asserted that the neighboring jurisdiction should be shown great deference when making a
reasonable judgment on the "will affect" determination since they administer their water quality
requirements.

Agency's Response: EPA finds that the statutory text of section 401(a)(2), and the consistent
text of section 121.14(a), sufficiently establish the "will violate standard," and therefore
declines to further define this standard. Like the Agency's "may affect" standard, the "will
violate" standard is necessarily broadly applicable, as it must be applied to differing
Federal licenses and permits in a wide range of factual circumstances. Accordingly, the
Agency is not modifying section 121.14 as suggested by the commenter; however, EPA
agrees that the "will violate" standard includes a discharge's contributions to water quality
violations. Therefore, the neighboring jurisdiction does not have to find that the discharge
itself violates water quality requirements and, instead, can find that the discharge
contributes to violations of water quality requirements to determine the "will violate"
standard is met. EPA further notes that the public, including interested stakeholders, will
have the opportunity to participate in any hearing on an objection conducted by the Federal
licensing or permitting agency, pursuant to section 401(a)(2) and section 121.15 of the final
rule.

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The Agency disagrees with commenter assertions that the Federal agency should afford
great deference to the neighboring jurisdiction with regard to its "will violate"
determination, as this is not reflected in section 401(a)(2). After conducting the public
hearing, pursuant to CWA section 401(a)(2), the Federal licensing or permitting agency
must consider the recommendations of the notified neighboring jurisdiction and EPA, as
well as any additional evidence presented at the hearing, as it determines whether
additional permit or license conditions are necessary to ensure compliance with applicable
water quality requirements. 33 U.S.C. 1341(a)(2). The Act does not accord special status to
any particular component; rather, the section appears to contemplate that the Federal
agency will consider all of the information presented in making its decision.

11.4.8 Withdrawal of Objection

Multiple commenters recommended that EPA include language allowing neighboring jurisdictions to
withdraw their objection before the hearing, therefore eliminating the requirement to hold a public
hearing. A commenter said that given that section 401(a)(2) provides a neighboring jurisdiction with the
sole discretion to make the objection and request in the first place, the neighboring jurisdiction may
decide to withdraw the objection. This commenter further said that this addition would help because if a
neighboring jurisdiction withdraws its objection, other parties likely would not be able to be relieved of
the public hearing. A different commenter said that to not allow for this would leave process and delay,
and another commenter said that a neighboring jurisdiction should be able to withdraw its objection if
they receive information that addresses their concerns or for any other reason. One commenter said that
all notices for a proposed public hearing should include reference to this rule language that a hearing may
be canceled. One commenter said that allowing a neighboring jurisdiction to withdraw its objection falls
within a state or Tribe's authority and is in line with section 401's cooperative federalism structure.

Agency's Response: EPA agrees that including a provision addressing withdrawal of an
objection improves the efficiency of the neighboring jurisdictions process, as it recognizes
the possibility that neighboring jurisdictions may be able to resolve objections before the
hearing stage of the neighboring jurisdictions process, conserving resources that would
otherwise be expended to conduct and participate in such a hearing in these circumstances.
EPA observes that nothing in the statute prohibits withdrawal of an objection, which would
remove the prerequisite condition for a Federal agency to hold a public hearing. EPA also
finds that including a provision addressing the circumstances of withdrawal provides added
clarity by establishing a uniform procedure for executing withdrawal of an objection.
Accordingly, EPA has included a provision in section 121.14(c) that allows a notified
neighboring jurisdiction to withdraw its objection prior to the public hearing. The final rule
states that if the notified neighboring jurisdiction withdraws its objection, it shall notify the
Regional Administrator and Federal agency in writing of the withdrawal. See 40 CFR
121.14(c). If the neighboring jurisdiction withdraws the objection, the Federal agency would
not need to proceed with a public hearing and could move forward with issuing the Federal
license or permit. EPA has also added language to this effect at section 121.15(a). It should
be noted that the Federal agency might have to comply with its own public notice

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procedures if it agreed to add certain Federal license or permit conditions in return for
withdrawal of the objection.

11.5 Public Hearing

11.5.1 General

One commenter supported EPA's proposed approach to the public hearing process but suggested that
EPA should develop hearing procedures that can act as a default for Federal agencies that do not have
public hearing procedures. Conversely, another commenter said that EPA should not impose a minimum
notice requirement for Federal agency hearings under section 401(a)(2).

A commenter said that if a public hearing is necessary, it is reasonable for the neighboring jurisdiction to
hold their hearing at the same time as the certifying authority.

A few commenters suggested EPA create a timeline of the neighboring jurisdiction process and
specifically include timelines for establishing the public hearing, making determinations, and finishing the
post-public hearing process.

One commenter asserted that the certifying authority should be invited to contribute information leading
up to and at the public hearing, because it understands its own water quality standards and processes best,
spent up to a year reviewing the decision, and has resources pertinent to the decision-making process.
Accordingly, the commenter requested that the proposed rule be modified to ensure the certifying
authority received a copy of the final Federal license or permit; notification if a neighboring jurisdiction is
granted a section 401(a)(2) hearing; information on how to participate in the section 401(a)(2) process;
and notification of the section 401(a)(2) determination.

Agency's Response: EPA is finalizing the proposed requirement that the Federal agency
must provide notice at least 30-days prior to the public hearing. EPA is also adding
language in section 121.15(b) that requires the Federal agency to provide public notice "to
interested parties, including but not limited to the neighboring jurisdiction, the certifying
authority, the project proponent and the Regional Administrator," at least 30 days prior to
the public hearing. 40 CFR 121.15(b). This language was included to ensure that all
interested parties will have notice of the public hearing such that they can prepare for and
provide their testimony or comments at the public hearing. Otherwise, the Agency is
maintaining the approach of not defining the type of public hearing that the Federal agency
must hold, since many Federal agencies have their own regulations regarding public
hearings on licenses and permits, and the Federal agencies are better suited to determine
the appropriate process for holding their own public hearings. However, EPA recommends
that the Federal agency accept comments and additional evidence on the objection at the
public hearing.

The Agency disagrees that it would be reasonable for the neighboring jurisdiction to hold
their hearing at the same time as the certifying authority. Assuming the commenter was

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referring to a certifying authority's potential public hearing on a request for certification
and the neighboring jurisdiction's request for a public hearing when it objects to the
issuance of a license or permit, the Agency observes such coordination would be
impracticable. The neighboring jurisdictions process is only initiated after a certifying
authority issues a certification or waiver. Conversely, section 401(a)(2) requires a certifying
authority to develop public notice procedures, and as appropriate public hearing
procedures, for requests for certification. As a result, any public hearing on a request for
certification must occur prior to the issuance of a certification decision and the neighboring
jurisdictions process.

Other than the 30-day timeline for EPA to make a "may affect" determination and 60-day
timeline for the neighboring jurisdiction, if notified by EPA, to object to the issuance of the
license or permit, section 401(a)(2) does not provide any timeframes for establishing the
public hearing. Aside from the timeframe for the Federal agency to provide public notice
before the public hearing, the Agency is declining to include further timeframes for the
neighboring jurisdictions process in the final rule. First, the Agency observes that various
types of projects and Federal licenses and permits may be subject to the section 401(a)(2)
process. As a result, the Agency does not find it practicable to impose a singular timeframe
on all projects. Second, the Agency has included a provision in section 121.14(c) that allows
a notified neighboring jurisdiction to withdraw its objection prior to the public hearing. If
the neighboring jurisdiction withdraws the objection, the Federal agency will not need to
proceed with a public hearing and can move forward with issuing the Federal license or
permit. Allowing for withdrawal of an objection recognizes the possibility that neighboring
jurisdictions may be able to resolve objections before the hearing stage of the neighboring
jurisdictions process, conserving resources that would otherwise be expended to conduct
and participate in such a hearing in these circumstances. To ensure Federal agencies and
neighboring jurisdictions are able to fully avail themselves to this potential resource saving
opportunity, the Agency declines to place any timeframes on establishing the public
hearing. See Section 11.6 of the Agency's Response to Comments document for further
response and discussion on why the Agency is declining to place any timeframes on the
Federal agency's determination after the public hearing.

Regarding the certifying authority's role in the neighboring jurisdictions process, unlike the
Regional Administrator and the Federal agency, EPA holds that the certifying authority
does not have a specific role under CWA section 401(a)(2). However, like the project
proponent, the certifying authority may participate in the neighboring jurisdictions process
by providing comments during the public hearing. EPA encourages the Federal agency to
involve the certifying authority in conversations that occur prior to the public hearing, if it
believes that the certifying authority may have information that could inform discussions
with the notified neighboring jurisdiction. EPA declines to prescribe how a Federal agency
must engage with stakeholders after the public hearing. However, EPA encourages the
Federal agency to consult with the objecting neighboring jurisdiction and certifying
authority, as well as all necessary parties, before making a decision under CWA section
401(a)(2).

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11.5.2

Location of the Public Hearing

A commenter stated that EPA should require that the public hearing be held in the neighboring
jurisdiction, citing to Corps of Engineers' regulations implementing section 401(a)(2), which require the
public hearing to be held in the neighboring jurisdiction. 33 CFR 325.2(b)(l)(i) ("the district engineer will
hold a public hearing in the objecting state"). However, the commenter also said that in appropriate cases,
the Federal agency could consult with the neighboring jurisdiction and agree to allow for a different
location or for the public hearing to be held virtually; but if the neighboring jurisdiction and Federal
agency are unable to come to agreement, the default should be a public hearing in the neighboring
jurisdiction. The commenter said that one purpose of section 401(a)(2) is to provide an opportunity for the
views of a neighboring jurisdiction in the Federal licensing or permitting process and in order to achieve
this, the public hearing must be held in the neighboring jurisdiction to maximize transparency and
elicitation of views from the objecting jurisdiction. The commenter said that by the time a public hearing
is held under section 401(a)(2), the certifying authority would have already had an opportunity for a
public hearing to elicit the views of that jurisdiction. The commenter also said that holding the public
hearing in the neighboring jurisdiction is practical in cases where a neighboring jurisdiction is located a
great distance from the certifying authority, noting that they were aware of instances where EPA notified
neighboring jurisdictions that were located hundreds of miles downstream of the certifying authority.

Agency's Response: Many Federal agencies have their own regulations regarding public
hearings on licenses and permits, and the Federal agencies are better suited to determine
the appropriate process for holding their own public hearings. EPA notes that, as a
commenter stated, there is at least one other Federal agency that has specific regulations
governing where a public hearing under CWA section 401(a)(2) will be held. EPA defers to
the Federal agency to decide whether the public hearing would be conducted in-person
and/or remotely through telephone, online, or other virtual platforms depending on the
circumstances and the Federal agency's public hearing regulations. In determining the
method for conducting the hearing and hearing location, EPA encourages the Federal
agency to take into consideration the purpose of CWA section 401(a)(2) to establish a
mechanism allowing notified neighboring jurisdictions an opportunity to object to the
issuance of a Federal license or permit in circumstances where they find a discharge from
the licensed or permitted project will violate their water quality requirements. Thus,
interested parties, which include representatives of the neighboring jurisdiction, should be
able to easily attend the public hearing.

11.5.3 EPA's Evaluation and Recommendation

One commenter said that EPA needs to recognize its additional obligations in cases involving Tribes with
TAS. The commenter stated the obligations are imposed by the trust relationship between the United
States and Tribes, see Seminole Nation v. United States, 316 U.S. 286, 296 (1942), and any trust duties
that may apply regarding a specific Tribe. The commenter said that it is unclear why EPA would not want
to consult with the neighboring jurisdiction, and they further said that specifically for Tribes, EPA's

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statement that it only "may" consult with neighboring jurisdiction "where it deems appropriate" would
violate EPA's Tribal consultation obligations to Tribes with TAS. The commenter stated that the purpose
of EPA's evaluation and recommendation is to examine the determination of the objecting jurisdiction
because section 401 does not provide the Federal agency with expertise or authority regarding water
quality to make that evaluation itself. Lastly, the commenter asserted that the Federal agency needs to
consult with both the objecting jurisdiction and EPA on any evidence to ensure a well-informed decision
for the section 401(a)(2) process.

Similarly, another commenter recommended that EPA notify Tribes and provide an opportunity to consult
prior to finalizing a neighboring jurisdiction determination to ensure that Tribes themselves are decision-
makers over what project types may impact their treaty resources and interests. The commenter argued
that Tribes are best suited to identify the project impacts that affect their interests and fear that the EPA
Administrator may inadvertently miss important projects with impacts to Tribes, given the unique
geography, history, and uses of the lands and waters within Tribal jurisdiction.

Agency's Response: As stated in its proposal, EPA interprets its role in providing the
evaluation and recommendations on the notified neighboring jurisdiction's objection as that
of an objective and neutral evaluator providing recommendations to the Federal licensing
or permitting agency based upon its expert, technical analysis of the record before it. 87 FR
35369. EPA intends to conduct its evaluation and make any recommendations based on the
information before it, giving equal consideration to the information and views—if
provided—by interested parties, including the objecting neighboring jurisdiction, project
proponent, and certifying authority. Id. Consistent with this approach, as a general matter
EPA does not intend to invite public comment and input from, or engage with, interested
parties when developing its evaluation and recommendations on the objection. However,
EPA may, where it deems it appropriate, seek additional information regarding a notified
neighboring jurisdiction's objection to be sure EPA is able to develop an informed and well-
supported evaluation and accompanying recommendations. This approach to developing its
evaluation and recommendations is consistent with the hearing process established by
section 401(a)(2), which recognizes a role for the notified neighboring jurisdiction
independent of the Agency and allows for presentation of evidence at the hearing by any
interested stakeholder, including the notified neighboring jurisdiction. If a stakeholder
agrees or disagrees with EPA's evaluation and recommendations presented at the hearing,
such stakeholder may have an opportunity to provide additional information and comment
directly to the Federal agency for its consideration.

When a neighboring jurisdiction is a Tribe, the Agency notes that EPA's "may affect"
determination and any subsequent evaluation and recommendations are informed by its
Tribal policies, including its Tribal consultation policies,8 and the Federal trust
responsibility to federally recognized Tribes. The Agency maintains its position that it has
sole discretion, pursuant to section 401(a)(2), to examine the facts and determine whether
the discharge "may affect" the quality of a neighboring jurisdiction's waters, including

8 For further discussion of the Agency's Tribal consultation policies, please see the Agency's Response to
Comments Section 8.1.

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those of a Tribe with TAS. The Agency further notes that tribal consultation would not be
possible on a "may affect" determination, given the limited statutory timeline. However, as
described in Section IV.K.2 of the final rule preamble, the Agency may consider a
neighboring jurisdiction's views on the effect of a discharge from the project on its water
quality as a factor in making a "may affect" determination, and the Agency intends to
consider such views of neighboring jurisdictions if provided in a timely manner. Consistent
with the role of the Agency in the section 401(a)(2) hearing process, as described in Section
IV.K.2.h of the final rule preamble, EPA does not intend to invite public comment and
input from, or engage with, interested parties when developing its evaluation and
recommendations on an objection. However, as indicated above, EPA may seek additional
information regarding a neighboring Tribe's objection to be sure EPA is able to develop an
informed and well-supported evaluation and accompanying recommendations.

11.6 Federal Agency Decision

Several commenters recommended that EPA set a deadline for the Federal agency to make a decision
after conducting a public hearing pursuant to section 401(a)(2). Commenters recommended different
timelines following the public hearing, including 7 days, 30 days, 60 days, and 90 days. One of these
commenters also added that EPA could propose that EPA has the discretion to extend a 90-day deadline if
the Federal agency requests it in writing with their reasons for the delay. Another commenter
recommended that EPA require the Federal agency to make their decision in a timely manner.

Conversely, one commenter stated that establishing a deadline would be inappropriate and inconsistent
with section 401(a)(2). The commenter asserted that Congress consciously chose not to impose a deadline
on the Federal agency and did not include language that would allow EPA to establish a deadline.

A few other commenters suggested that the Federal agency should set a deadline to make a final decision
within several days of the public hearing to ensure the timeline is not open-ended. One commenter said
that there should be a predictable timeline for the public hearing and recommended that the number of
days be limited for the addition of more information or conditions into the certification..

A couple of commenters said a 7-day deadline should apply to the certifying authority to decide and/or
incorporate more information into their certification. One commenter asserted that the Federal agency
should consult with the certifying authority if it determines additional permit conditions are required or to
discuss how the certifying authority's conditions could address a neighboring jurisdiction's concerns.

Agency's Response: In the final rule, the Agency is declining to add specific timelines for
the neighboring jurisdictions process beyond those already established in the statute. There
are many factors, including the complexity of the facts at issue in an objection and a Federal
agency's own regulations, that impact the duration of time necessary for a Federal agency
to complete its determination following a hearing on a neighboring jurisdiction's objection.
However, EPA encourages Federal agencies to communicate with the notified neighboring
jurisdiction and other interested stakeholders regarding its expectations or considerations
in determining the time to make a decision on the Federal license or permit after a public
hearing.

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In response to commenters suggesting that the timeframe to make a determination after the
public hearing applies to the certifying authority, the Agency observes that section 401(a)(2)
provides no specific role for the certifying authority. In fact, the neighboring jurisdictions
process occurs after the certifying authority has acted on a request for certification.
Accordingly, the certifying authority is not responsible for addressing the neighboring
jurisdiction's objection in its certification. The Federal agency must consider the
recommendations of the neighboring jurisdiction and EPA Administrator as well as any
additional evidence presented at the hearing and, based on that information, must condition
the Federal license or permit as may be necessary to ensure compliance with applicable
water quality requirements. If additional conditions cannot ensure compliance with
applicable water quality requirements, the Federal agency shall not issue the license or
permit. In response to the commenter suggesting that the Federal agency should consult
with the certifying authority if it decides to add permit conditions, EPA declines to
prescribe how a Federal agency must engage with stakeholders after the public hearing.
However, EPA does encourage the Federal agency to consult with the objecting neighboring
jurisdiction and certifying authority, as well as all necessary parties, before making a
decision under CWA section 401(a)(2).

11.7 Input Received on Prior Rulemakings

11.7.1 Pre-proposal Input from 2021

This sub-topic summarizes input that was received prior to the 2022 proposed rule and was resubmitted
by commenters in the docket for the 2022 proposed rule.

A couple stakeholders asserted the importance of the neighboring jurisdiction process in safeguarding
Tribal water quality. One stakeholder stated that any revised section 401 rule should clarify that the
section 401(a)(2) "may affect" determination is not discretionary and is required under the plain text of
the CWA. Another stakeholder urged EPA to always notify neighboring jurisdiction of licensed activities,
allowing them to chance to analyze any potential impacts to their waters.

On the other hand, another stakeholder said that EPA should have greater discretion in subjecting projects
to review for neighboring jurisdictions to provide efficiency and prevent unnecessary delays for projects
that appear sufficiently distant from borders of neighboring jurisdictions.

One stakeholder encouraged EPA to consider how to best balance the concerns of neighboring
jurisdictions and the benefits associated with the timely approval of projects. This stakeholder expressed
support for EPA's section 401(a)(2) best practices guidance and asserted that it specifically state that any
decision by an EPA Region to issue a "may affect" determination should be supported by data that
demonstrates the water quality effects on the neighboring jurisdiction's waters.

Agency's Response: See the Agency's Response to Comments in Sections 11.1-11.6; see also
Section IV.K of the final rule preamble.

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12. Treatment in a Similar Manner as a State (TAS) (Section 121.11)

12.1 Proposal to Add TAS Provisions for Solely Section 401 and 401(a)(2)

Many of the commenters addressing the proposal to add provisions enabling Tribes to obtain TAS solely
for section 401 and for 401(a)(2) supported the proposal. Commenters identified reasons for supporting
the proposed TAS provisions as including interest in supporting Tribal agency, increasing Tribal
participation in Federal licensing and permitting processes, providing Tribes a tool for protecting water
quality and treaty rights, recognizing the vast knowledge of Tribal communities and their sovereignty,
respecting the role waters play in their cultures, and affording Tribes more options regarding
administration of CWA programs. Several commenters specifically expressed support for providing a
TAS provision for participation in the section 401(a)(2) neighboring jurisdiction process. A commenter
noted that the proposed TAS provision for section 401(a)(2) is responsive to concerns regarding the
inability of Tribes to participate in the neighboring jurisdiction process without TAS. One commenter
said that waters on reservations are susceptible to degradation from upstream, off-reservation discharges,
so it is therefore essential that Tribes have a mechanism for objecting to and requesting a hearing on the
issuance of permits or licenses for these discharges. The commenter also said that EPA's proposal creates
such a mechanism while avoiding the administrative burdens associated with obtaining full section
401(a)(1) authority.

Some commenters opposed or expressed concerns regarding the approach in the proposal to add
provisions enabling Tribes to obtain TAS. Commenters taking this position raised concerns including
concern that the proposed provisions would expand the number of certifying authorities and potentially
complicate or delay the certification process, and concern that Tribes seeking or obtaining TAS under
such provisions may lack technical resources, experience, or capability to administer section 401
programs. Some of the commenters expressing opposition or concern regarding the proposed TAS
provisions asserted the position that section 401 is limited to ensuring compliance with EPA-approved
water quality standards, and questioned how Tribes without a water quality standards program under
section 303(c) of the CWA would implement section 401. Additionally, a commenter expressing
opposition to the proposed TAS provisions further asserted that the statutory language of section 401
implies that the certifying authority has authority to administer sections 301, 302, 303, 306, and 307 of
the CWA, and argued that TAS should be limited Tribes administering such programs. Another
commenter asserted that EPA should provide additional legal support for finding that the section
401(a)(2) process is severable from section 401 for purposes of the proposed TAS provision for
administering solely section 401(a)(2).

Some of the commenters opposing or expressing concerns regarding the proposed TAS provisions offered
alternative approaches. Some such commenters suggested that EPA should make TAS available only to
Tribes with TAS for section 303(c) or Tribes that are implementing water quality standards programs.
Another commenter expressed concern that EPA did not provide adequate notice to potential stakeholders
on the TAS proposals, and suggested that EPA defer addressing a TAS provision for section 401 until a
subsequent rulemaking effort.

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Agency's Response: EPA appreciates commenters' support of the section 401 TAS
provisions. Promulgating a regulation expressly providing a process and requirements for
section 401 TAS in the absence of section 303(c) TAS is consistent with section 518 and
would provide clarity and increased opportunities for interested Tribes to participate in
section 401. CWA section 518 authorizes the Agency to treat eligible Tribes with
reservations in a similar manner to states "for purposes of subchapter II of this chapter and
sections ... 1341,... of this title to the degree necessary to carry out the objectives of this
section." See 33 U.S.C. 1377(e). Section 518(e) establishes eligibility criteria for TAS.9
Additionally, developing regulations on section 401 TAS as a standalone process for Tribes
seeking this authority who are not concurrently applying for section 303(c) TAS may
encourage more Tribes to seek TAS for section 401. Decoupling section 401 TAS from
section 303(c) recognizes that section 401 and section 303(c) administration are related, but
distinct functions and is responsive to Tribal stakeholders who have expressed an interest in
participating in the section 401 certification process. The Agency recognizes that the
number of certifying authorities is likely to increase as a result of the new TAS provisions,
and it does not view this increase as problematic. Increasing the opportunities for interested
Tribes to participate in section 401 through the new TAS provisions is consistent with the
cooperative federalism principles and intent of section 401. The final rule includes
provisions, such as pre-filing meeting requests and request for certification, that may help
streamline the certification process and limit delays. Additionally, the final rule clarifies
that certifying authorities, including Tribes with TAS, may request technical assistance
during the certification process, as provided for in section 121.18. See 40 CFR 121.18.

The final rule promotes Tribal engagement by providing an opportunity for Tribes to
protect their water quality through participating in the section 401 certification process
without needing to assume all of the authorities and responsibilities of section 401. Tribes
applying for TAS solely for section 401(a)(2) will still need to meet the same four criteria
discussed in section IV.L of the final rule preamble. However, since participating as a
neighboring jurisdiction under section 401(a)(2) does not involve any exercise of regulatory
authority and involves carrying out fewer functions than acting as a certifying authority,
EPA anticipates that demonstrations that the applicant Tribe satisfies the criteria will be
more streamlined than the demonstrations in applications for TAS for purposes of
administering the entirety of section 401.

9 Section 518(e) authorizes EPA to treat eligible Tribes in a similar manner as a state if "(1) the Indian
tribe has a governing body carrying out substantial governmental duties and powers; (2) the functions to
be exercised by the Indian tribe pertain to the management and protection of water resources which are
held by an Indian tribe, held by the United States in trust for Indians, held by a member of an Indian tribe
if such property interest is subject to a trust restriction on alienation, or otherwise within the borders of an
Indian reservation; and (3) the Indian tribe is reasonably expected to be capable, in the Administrator's
judgment, of carrying out the functions to be exercised in a manner consistent with the terms and
purposes of this chapter and of all applicable regulations." See 33 U.S.C. 1377(e).

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EPA disagrees that section 401 is limited to ensuring compliance with Clean Water Act
section 303(c) water quality standards. The term "water quality requirements" is used
throughout section 401, and EPA has defined "water quality requirements" to include any
limitation, standard, or other requirement under the provisions enumerated in section
401(a)(1), any Federal and state or Tribal laws or regulations implementing the enumerated
provisions, and any other water quality-related requirement of state or Tribal law
regardless of whether they apply to point or nonpoint source discharges. 40 CFR 121.l(j).
Under this approach, authorized Tribes can base their section 401 certification decisions on
compliance with water quality requirements other than Tribal water quality standards
approved under section 303(c). Examples include Tribal ordinances or other Tribal laws
related to water quality, or, if present, Federal water quality standards promulgated by
EPA for reservation waters.10

Likewise, EPA disagrees that certification authority under section 401 is contingent upon
authority to administer sections 301, 302, 303, 306, and 307 of the CWA. The assertion that
certification authority for section 401 requires administration of sections 301, 302, 303, 306,
and 307 of the CWA is inconsistent with the text of section 401, which does not impose such
a requirement. Additionally, this is inconsistent with EPA's practices prior to this final
rulemaking regarding obtaining TAS for section 401 in conjunction with TAS for section
303(c) pursuant to the TAS provision for the water quality standards program in 40 CFR
131.8.

The Agency finds that the neighboring jurisdictions process established in section 401(a)(2)
is distinct from the process for certification. For further discussion and comparison of the
processes, see Section IV.K.2.b in the final rule preamble.

The Agency disagrees with commenter assertions that the Agency did not provide adequate
notice on the proposed TAS provisions. On June 9, 2022, the Agency published the
proposed rulemaking in the Federal Register, 87 FR 35318, which initiated a 60-day public
comment period that lasted through August 8, 2022. EPA held a virtual public hearing on
July 18, 2022, and hosted a series of stakeholder listening sessions throughout June 2022,
including one listening session for project proponents on June 14, 2022, three listening
sessions for States and territories on June 15, 22, and 28, 2022, and three listening sessions
for Tribes on June 15, 22, and 28, 2022. The Agency also hosted a Federal agency listening
session on June 14, 2022. In finalizing the proposed rule, the Agency reviewed and
considered approximately 27,000 comments received on the proposed rulemaking from a
broad spectrum of interested parties. Commenters provided a wide range of feedback on
the proposal, including the substantive and procedural aspects of the certification process,
how the proposed rule would impact stakeholders, and the legal basis for the proposed rule.

10 Federal water quality standards are currently in place for the Confederated Tribes of the Colville
Reservation. See 40 CFR 131.35. EPA recently published a proposed rule that would establish Federal
baseline water quality standards for waters on Indian reservations that do not have water quality standards
in effect for CWA purposes. 88 FR 29496 (May 5, 2023). Upon finalizing the rule, those Federal baseline
water quality standards would serve as the applicable water quality standards in effect for CWA purposes.

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The Agency discusses comments received and responses in the applicable sections of the
preamble to this final rule. The APA requires agencies to "give interested persons an
opportunity to participate in the rule making through submission of written data, views, or
arguments with or without opportunity for oral presentation." 5 U.S.C. 553(c). The APA
does not specify a minimum number of days for accepting comments on a proposed rule.
The Agency complied with its obligation under the APA to provide a reasonable length of
time for interested parties to comment on the proposed rule. Moreover, a pre-publication
version of the proposed rule was posted on the EPA's website on June 2, 2022, which was 7
days prior to its publication in the Federal Register and the date the public comment period
began.

12.2 Oklahoma-Specific Concerns

Some commenters discussing the TAS provisions in the proposal noted, or raised concerns regarding,
special circumstances involving the ability of Oklahoma to oversee environmental programs in Indian
Country pursuant to the Safe, Accountable, Flexible, Efficient Transportation Equity Act of 2005
(SAFETEA). A few commenters requested that EPA provide explicit acknowledgement of the specific
circumstances regarding Oklahoma's authority under SAFETEA and note that TAS provisions for section
401 are subject to limitations consistent with this authority. Another commenter requested that EPA
provide an explicit statement of its intent if it intends the proposed TAS provisions not to be subject to
limitations pursuant to SAFETEA.

Agency's Response: EPA is aware that section 10211(b) of SAFETEA established a unique
TAS requirement with respect to Indian Tribes located in the State of Oklahoma. Under
section 10211(b), Tribes in Oklahoma seeking TAS under a statute administered by EPA
for the purpose of administering an environmental regulatory program must, in addition to
meeting applicable TAS requirements under the EPA statute, enter into a cooperative
agreement with the state that is subject to EPA approval and that provides for the Tribe
and state to jointly plan and administer program requirements. This requirement of
SAFETEA exists apart from, and in addition to, the TAS criteria established by statutes
administered by EPA, including the TAS criteria set forth in section 518 of the CWA. The
provisions of today's final rule establishing an opportunity for interested Tribes to obtain
TAS for purposes of administering certifications under section 401 without separately
needing to obtain TAS for section 303(c) relate solely to the TAS requirements of CWA
section 518. They have no effect on the separate TAS requirement of section 10211(b) of
SAFETEA, which must also be satisfied by any Tribe in Oklahoma seeking TAS for
purposes of administering section 401 certifications. In this regard, the requirement of
section 10211(b) of SAFETEA applies identically whether a Tribe in Oklahoma seeks TAS
to administer section 401 certifications under today's final rule, or under existing
regulations authorizing TAS for section 401 certifications as an adjunct to TAS for section
303(c) water quality standards. EPA notes, however, that consistent with the terms of
section 10211 of SAFETEA and established practice, the requirements of section 10211(b)
apply only where a Tribe in Oklahoma seeks TAS for the purpose of administering a
regulatory program under a statute administered by EPA. Such requirements do not apply

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where a Tribe in Oklahoma seeks TAS for non-regulatory functions - e.g., receiving grants
under EPA programs or performing other functions that do not involve any exercise of
regulatory authority by the applicant Tribe. Functioning as a neighboring jurisdiction
under section 401(a)(2) does not involve any exercise of regulatory authority by a Tribe (or
state) who may be affected by a federally licensed or permitted discharge from another
jurisdiction. The neighboring jurisdiction role involves an opportunity to provide input
regarding water quality impacts and to inform decision making of the Federal licensing or
permitting agency. Ultimately, it is the Federal agency that exercises regulatory authority
through its licensing or permitting decision, and the certifying agency in the other
jurisdiction where the discharge originates that exercises authority to grant, grant with
conditions, deny, or waive certification. In this regard, the section 401(a)(2) neighboring
jurisdiction role is similar to the affected state commenting role established under section
505(a)(2) of the Clean Air Act. See 87 FR 35372. EPA has approved numerous Tribes
(including Tribes in Oklahoma) for TAS for the severable Clean Air Act affected state role.
Such Tribal applications for Tribes in Oklahoma have not triggered the requirements of
SAFETEA section 10211(b). Similarly, a TAS application from a Tribe in Oklahoma for the
limited neighboring jurisdiction role of section 401(a)(2) would not implicate section
10211(b) of SAFETEA. A TAS application for the section 401 certification role, however,
would trigger the SAFETEA requirements.

12.3 TAS Application Process

Some of the commenters addressing the TAS provisions in the proposal discussed the application process
for Tribes seeking TAS under these provisions. Some such commenters requested that EPA provide
transparency on TAS applications, for example, by establishing clear standards for applications,
identifying necessary materials for applications, and communicating application status with applicants. A
commenter noted the criteria stated in the proposal for evaluating TAS applications for section 401 and
expressed support for such criteria. Several commenters raised concerns regarding the duration of time
EPA may take to process TAS applications for section 401 and section 401(a)(2), and some requested that
EPA employ measures such as monitoring application processing time and establishing rules to ensure
efficient processing of applications. Additionally, a commenter requested that EPA clarify how it will
inform Tribes regarding application status. Some commenters noted that EPA may request additional
information from Tribes seeking TAS under the proposal and raised concerns about the burdens this may
impose on applicants. A commenter argued that EPA should narrowly tailor information requests to the
issue of a Tribe's ability to manage the program it is seeking to administer and establish clear guidelines
on the materials needed for an application. Additionally, a commenter requested that EPA clarify whether
it will require notice of a TAS application to a broader group than the "appropriate governmental entities"
as currently defined, and opposed EPA adopting broader notice procedures due to concerns regarding
process delay, increased Tribal administrative costs, and providing a platform for hostility against Tribes.

Another commenter said that under the proposed rule it is unclear whether the process set forth in section
121.11 applies to both Tribes seeking full certification authority and "neighboring jurisdiction authority;"
or whether the EPA will use a separate process to evaluate Tribes' requests for "neighboring jurisdiction"
only. The commenter recommended clarifying this.

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Another commenter asserted that it was unclear from publicly available materials what steps EPA has
taken to consult with Tribes regarding the proposed TAS process, and argued that EPA must consult
Tribes on the proposed TAS application process and ensure that this process does not impose unnecessary
or burdensome obligations that may discourage or prevent Tribes from seeking TAS status.

Agency's Response: EPA agrees that the TAS application process should be transparent
and has included provisions in this final rule to create clarity and efficiencies in the
application process. To provide direction on how a Tribe may meet the criteria described in
section IV.L.l of the final rule preamble, EPA has described the contents of an application
for TAS for section 401. See 40 CFR 121.11(b). To assist applicant Tribes, the Agency is also
developing a template which would provide explanations and instructions for documenting
how the Tribe meets the eligibility requirements. The template would consist of areas for
Tribes to include a statement that the Tribe is recognized by the Secretary of the Interior, a
descriptive statement that demonstrates the Tribal government carries out substantial
duties and powers, a descriptive statement of the Tribe's authority to regulate water
quality, and a narrative statement that describes the Tribe's capability to administer a
section 401 water quality certification program.

Consistent with existing TAS regulations for other programs, this final rule also provides
that Tribal applicants include additional documentation that may be required by EPA to
support the Tribal application. Each TAS application will present its own set of legal and
factual circumstances, and EPA anticipates that in some cases it may be necessary to
request additional information when reviewing a Tribe's application. Such requests would,
for instance, generally relate to ensuring that the application contains sufficient complete
information to address the required statutory and regulatory TAS criteria. This could
include, for instance, information relating to a unique issue pertaining to the applicant
Tribe or its reservation or an issue identified during the comment process described below.
Consistent with longstanding practice, the Agency would work with Tribes in an
appropriately streamlined manner to ensure that their TAS applications contain all
necessary information to address applicable statutory and regulatory criteria. If a Tribe has
previously qualified for TAS under another EPA program, the Tribe is only required to
submit information that was not previously submitted as part of a prior TAS application.

The final rule also describes EPA's procedures to review and process an application for
section 401 TAS. See 40 CFR 121.11(c). Once EPA receives a complete Tribal application, it
will promptly notify the Tribe of receipt and process the application in a timely manner.
Within 30 days after receipt of the Tribe's complete application for section 401 TAS, EPA
shall provide notice to appropriate governmental entities11 of the application, including

11 EPA defines the term "appropriate governmental entities" as "States, tribes, and other Federal entities
located contiguous to the reservation of the tribe which is applying for treatment as a State." 56 FR
64876, 64884 (December 12, 1991).

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information on the substance of and basis for the Tribe's assertion of authority to regulate
reservation water quality. Appropriate governmental entities will be given 30 days to
provide comment on the Tribe's assertion of authority. Consistent with prior practice
regarding such notice in connection with TAS applications for other programs, EPA also
intends to provide sufficiently broad notice (e.gthrough local newspapers, electronic
media, or other appropriate media) to inform other potentially interested entities of the
applicant Tribe's complete application and of the opportunity to provide relevant
information regarding the Tribe's assertion of authority. If the Tribe's assertion of
authority is challenged, EPA will determine whether the Tribe has adequately
demonstrated authority to regulate water quality on the reservation after considering all
relevant comments received.

The eligibility requirements in CWA section 518(e) and the process in section 121.11 of the
final rule apply to Tribes seeking TAS status for section 401 and section 401(a)(2). However,
as noted above, the Agency is also developing a template which would provide explanations
and instructions for documenting how the Tribe meets the eligibility requirement for both
section 401 TAS and section 401(a)(2) TAS.

As discussed in Section IV.F, EPA consulted with Tribal officials under the EPA Policy on
Consultation and Coordination with Indian Tribes early in the process of developing this
rulemaking to allow them to have meaningful and timely input into its development. EPA
has developed a final Summary Report of Tribal Consultation and Engagement for the
Clean Water Act Section 401 Water Quality Certification Improvement Rule which further
describes EPA's efforts to engage with Tribal representatives and is available in the docket
for this rulemaking. See Section IV.F for further discussion on the Agency's Tribal
consultation and coordination efforts for this rulemaking; see also Section 15.2.2 of the
Agency's Response to Comments document.

12.4 Implementation Considerations

Some commenters addressing the proposed TAS provisions requested that EPA take certain actions to
assist in implementation of these provisions. A commenter requested that EPA provide updated policy
guidance to clarify the TAS application process. Another commenter requested that EPA provide further
detail in the final rule to clarify what water quality standards a Tribe with TAS for section 401 but not
section 303 would apply in a certification analysis. Additionally, a commenter urged EPA to affirmatively
state the position in the final rule that the Federal government and Tribal governments hold exclusive
jurisdiction over waters in Indian country in order to reduce jurisdictional uncertainty and unnecessary
litigation for Tribes with TAS for section 401.

Agency's Response: The Agency is developing materials to aid the implementation of this
aspect of the final rule. To implement the TAS provisions in the final rule, EPA will need to
communicate how Tribes can apply and process any incoming TAS applications from
Tribes. To provide direction on how a Tribe may meet the criteria described in section
IV.L.l of the final rule preamble, EPA has described the contents of an application for TAS

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for section 401. See 40 CFR 121.11(b). To assist applicant Tribes, the Agency is also
developing a template which would provide explanations and instructions for documenting
how the Tribe meets the eligibility requirements. The template would consist of areas for
Tribes to include a statement that the Tribe is recognized by the Secretary of the Interior, a
descriptive statement that demonstrates the Tribal government carries out substantial
duties and powers, a descriptive statement of the Tribe's authority to regulate water
quality, and a narrative statement that describes the Tribe's capability to administer a
section 401 water quality certification program.

In the final rule preamble, EPA clarifies that authorized Tribes can base their section 401
certification decisions on compliance with water quality requirements other than Tribal
water quality standards approved under section 303(c). Examples include Tribal ordinances
or other Tribal laws related to water quality, or, if present, Federal water quality standards
promulgated by EPA for reservation waters.12

The Agency notes that CWA section 518(e) requires a Tribe to have appropriate authority
to regulate and manage water resources within the borders of the Tribe's reservation as one
criterion to obtain TAS for section 401. To meet the third criterion that the Tribe has the
authority to manage the water resources within the borders of the Tribe's reservation, the
Tribe would submit a descriptive statement comprised of two components: (1) a map or
legal description of the area over which the Tribe has authority to regulate surface water
quality, and (2) a statement signed by the Tribe's legal counsel or equivalent explaining the
legal basis for the Tribe's regulatory authority. EPA notes that section 518 of the CWA
includes a delegation of authority from Congress to eligible Indian Tribes to regulate the
quality of waters of their reservations under the CWA. See 81 FR 30183 (May 16, 2016).
Absent rare circumstances that may affect a Tribe's ability to effectuate the delegation of
authority, Tribes may rely on the congressional delegation of authority included in section
518 of the statute as the source of authority to administer a section 401 water quality
certification program. The Agency believes this criterion should reduce any jurisdictional
uncertainty for projects seeking certification in waters where a Tribe has obtained section
401 TAS.

13. Implementation

13.1 Effective Date

A commenter said that EPA should consider the time of year when promulgating the proposed rule, for

example, promulgating prior to springtime when construction project activities tend to accelerate to allow

12 Federal water quality standards are currently in place for the Confederated Tribes of the Colville
Reservation. See 40 CFR 131.35. EPA recently published a proposed rule that would establish Federal
baseline water quality standards for waters on Indian reservations that do not have water quality standards
in effect for CWA purposes. 88 FR 29496 (May 5, 2023). Upon finalizing the rule, those Federal baseline
water quality standards would serve as the applicable water quality standards in effect for CWA purposes.

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Federal agencies, certifying authorities, and authorized Tribes to become familiar with the contents and
implementation of the proposed rule requirements.

Another commenter said that a delayed effective date would provide certifying authorities and Federal
agencies an opportunity to make process improvements and draft or revise coordination agreements,
regulatory templates, and guidance documents, as well as give project proponents time to become
educated about the new rule and its requirements. One commenter requested that applications that were
received before the proposal rule and had not had its reasonable period of time officially determined be
governed by the proposed rule.

Agency's Response: EPA appreciates commenter input on the effective date of the final
rule. This final rule will be effective 60 days after the final rule publishes in the Federal
Register. The Agency does not find it necessary to delay the effective date. First, given that
EPA intends many of the provisions of the final rule to represent a return to past practices
with added clarity, the Agency anticipates that implementation of the final rule will not
require a significant overhaul of state, Tribal, or other Federal regulations. Second, EPA
will support implementation of the final rule through training sessions for each of the
various stakeholder groups, as well as through engagement with an interagency Federal
CWA section 401 workgroup.

The Agency also wishes to clarify the applicability of the final rule to ongoing certification
actions. As of the effective date of this final rule, which will be 60 days after publication of
the final rule in the Federal Register, all actions taken as part of the section 401 certification
process must be taken pursuant to the final rule. However, the final rule does not apply
retroactively to actions already taken under the 2020 Rule. For example, if a certifying
authority received a request for certification, prior to the effective date of this final rule,
and the certifying authority has not acted on the request for certification as of the effective
date, any decision issued by the certifying authority after the effective date of this final rule
must comply with the requirements in the final rule (e.g., scope of certification) and any
Federal agency review of a certification decision must comply with section 121.8. However,
the validity of the request for certification would be determined under the 2020 Rule and
the project proponent would not need to re-request certification consistent with the final
rule. The certifying authority may request more information to help inform its decision-
making on the request for certification, including information relevant to determining
water-quality impacts from the activity subject to certification, but the certifying authority
must still issue its certification decision within the reasonable period of time, which would
not pause while the certifying authority is seeking more information.13 A "reasonable period
of time" determined under the 2020 Rule prior to the effective date of the final rule would

13 Under both this final rule and the 2020 Rule, a certifying authority may request more information to
help inform its decision-making after a request for certification is made and the reasonable period of time
has begun. See section IV.C and 85 FR 42245 ("Nothing in the final rule's definition of "certification
request" precludes a project proponent from submitting additional, relevant information or precludes a
certifying authority from requesting and evaluating additional information within the reasonable period of
time").

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not automatically change because this final rule went into effect; however, the certifying
authority may request an extension to the reasonable period of time pursuant to section
121.6(e) of the final rule, or avail itself to an automatic extension to the reasonable period of
time pursuant to section 121.6(d) - provided that the reasonable period of time does not
exceed one year from the date that the request for certification was received. Additionally,
after the effective date, if a project proponent has not submitted a request for certification
or if the project proponent has only submitted a pre-filing meeting request by the time the
final rule goes into effect, the project proponent is responsible for submitting a request for
certification in accordance with section 121.5 of the final rule. Finally, after the effective
date, a certifying authority and Federal agency can apply the final rule's modification
process at section 121.10 to any certification decision, even if that decision was provided
while a prior rule (e.g., 1971 Rule or 2020 Rule) was in effect.14 Similarly, if a Federal
agency determined pursuant to the 2020 Rule and prior to the effective date of the final rule
that a certifying authority constructively waived certification for failure to comply with the
procedural requirements of the 2020 Rule, that determination is not affected by this final
rule going into effect, even if the relevant Federal license or permit has not yet been issued.
As discussed above, if a "reasonable period of time" was established under the 2020 Rule
prior to the effective date of the final rule, that reasonable period of time would not
automatically change because this final rule went into effect.

The approach the Agency adopts here regarding the applicability of the final rule to
ongoing certification actions is consistent with the approach taken by the Agency after a
court vacatur of the 2020 Rule in 2021 and the Supreme Court's stay of that vacatur in
2022. See Section III.C.3 in the final rule preamble for background on the litigation to the
2020 Rule. The Agency is not aware of any disruptions or delays in the certification process
as the result of the Agency's approach to ongoing certification actions in those instances.

13.2 Implementation Challenges and Coordination

Another commenter said that state agencies have experienced challenges implementing their section 401
responsibilities over the years due to insufficient resources, such as limited staff and time that is split
between other responsibilities. The commenter said this has led to difficulties addressing all the
correspondence and inquiries received about section 401 certifications as well as ensuring that the project
certified (e.g., based on a Federal permit application) was the project actually permitted and built.
According to the commenter, before the 2020 Rule was issued, the Corps allowed state agencies to issue
their certifications after a final Federal permitting decision was reached, which fostered more efficient
certification decisions.

A couple of commenters said that it is essential that EPA coordinate closely with other Federal agencies
(such as with the Corps and FERC) to avoid circumstances where regulations could be interpreted as
inconsistent with one another and to fully educate Federal licensing/permitting authorities of the changes

14 However, if the relevant Federal license or permit has not yet been issued, the project proponent could
request certification anew, and the certifying authority would then need to act on that request consistent
with this final rule.

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in the water quality certification process so that they are fully informed of their roles, responsibilities, and
legal limitations. One of these commenters further asserted that EPA should explore joint applications, or
a single multi-purpose application process, for similar CWA permitting schemes to foster a better use of
state and Federal government resources while increasing efficiency in the permitting process.

Agency's Response: The Agency appreciates commenter input regarding implementation
challenges. The Agency notes that this final rule provides several benefits to the certification
process including regulatory certainty and transparency, efficient certification reviews, and
enhanced cooperative federalism. These benefits may alleviate some implementation
challenges.

In response to the comment regarding past practices issuing certifications after a final
Federal permitting decision is reached, the Agency observes this practice is inconsistent
with section 401. A final Federal license or permit may not be issued until after a
certification or waiver is obtained by the project proponent. 33 U.S.C 1341(a)(1) ("No
license or permit shall be granted until certification required by this section has been
obtained or has been waived as provided in the preceding sentence.") Therefore, requiring a
copy of the final Federal license or permit to initiate the certification process would be
inconsistent with the plain language of section 401.

The Agency appreciates commenter input regarding the importance of interagency
coordination. EPA has hosted a CWA Section 401 Interagency Workgroup since 2019. The
Agency intends to continue coordinating with other Federal agencies to support the rollout
and implementation of the final rule.

The Agency recognizes that certifying authorities and Federal agencies coordinated in a
variety of ways prior to the 2020 Rule, such as joint applications and joint public notice
processes. Nothing in this final rule precludes such coordination, to the extent it is
consistent with this final rule. However, this final rule does not require certifying
authorities and Federal agencies to use joint applications or joint public notices.

13.3 Implementation Tools

A couple of commenters said that EPA should update and finalize the Clean Water Act Section 401 Water
Quality Certification: A Water Quality Protection Tool for States and Tribes (May 2010) interim guidance
handbook (rescinded in 2019). One commenter also said that other useful implementation materials would
include a frequently asked questions document that is available online and downloadable, a dedicated
webpage linking to other Federal agency procedures and requirements for certification, and interactive
digital mapping that identifies resources that will trigger neighboring jurisdictional effects determinations
automatically for project proponents and jurisdictions (i.e.. use of the Watershed Resources Registry for
additional layers) in the planing and review of a project.

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Another commenter said that EPA should provide guidance on how the proposed rule's various
components apply to existing certifications issued prior to the proposed rule's effective date, specifically
for actions taken under the 2020 Rule.

A commenter also said that an EPA-sponsored fact sheet or more detailed guidance document that
Federal agencies and certifying authorities could make available to project proponents would ensure all
parties have clear guidance on the new rule's requirements.

Agency's Response: The Agency appreciates commenter suggestions regarding
implementation tools. The Agency intends to develop several implementation resources,
including fact sheets and webinars, and will make them available on the EPA section 401
webpage, https://www.epa.gOY/cwa-401. The Agency will continue to explore development
of implementation resources as time and resources are available.

See also Section 13.1 of the Agency's Response to Comments.

13.4 Input Received in Prior Rulemakings

13.4.1 Input on the 2019 Proposed Rule

This sub-topic summarizes comments that were made on a previous proposed rulemaking and were
resubmitted by commenters in the docket for the 2022 proposed rule.

A few commenters discussed prior guidance documents in their comments on the 2019 proposed rule.
One commenter recommended that EPA codify the statutory principles described in the 2019 Guidance to
support effective implementation of Section 401 because the 1971 Rule predated the 1972 amendments to
the CWA. Another commenter recommended that EPA consider the implementation guidance provided in
the 2010 Handbook when updating the 1971 Rule.

One commenter recommended that EPA develop a dispute resolution process for certification decisions
when updating the 1971 Rule to support implementation of a new rule.

Another commenter proposed a process for early and frequent communication between project
proponents, certifying authorities, and Federal agencies to support best practices for implementation of
the section 401 regulations. The commenter also asserted that early communication allows for informed
certification decisions. For implementation, the commenter recommended clearly defined application
requirements, templates, and clear instructions.

One commenter recommended that EPA give certifying authorities a substantial amount of time to
evaluate and properly implement the 2019 proposed rule, so EPA should determine the applicability date
through consultation with the states.

Agency's Response: See the Agency's Response to Comments in Sections 13.1-13.3.

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The Agency notes that both the 2010 and 2019 guidance documents were rescinded. See
Section III.C.2 for further discussion on these documents.

The Agency declines to develop a dispute resolution process for certification decisions. See
Section IV.F and G of the final rule preamble for further discussion on certification
decisions and Federal agency review.

The Agency notes that several aspects of this final rule support early engagement and
coordination between certifying authorities, project proponent, and Federal agencies. See,
e.g., Section IV.B, C, D of the final rule preamble.

13.4.2 Pre-proposal Input from 2021

This sub-topic summarizes input that was received prior to the 2022 proposed rule and was resubmitted
by commenters in the docket for the 2022 proposed rule.

One stakeholder stated that some states had concerns with implementation of the 2020 Rule because the
2020 Rule did not account for the impact on existing state certification decisions. The stakeholder
asserted that states are issuing more denials of certification due to complications and time constraints with
implementation of the 2020 Rule. The stakeholder described the NOI to review and revise the 2020 Rule
as causing confusion around implementation of the 2020 Rule because the certifying authorities were
unsure whether to continue implementing the 2020 Rule or wait for EPA's efforts to review and revise the
2020 Rule.

Agency's Response: EPA recognizes stakeholder confusion around implementation of the
2020 Rule after EPA announced its NOI to review and revise the 2020 Rule; however, EPA
indicated on its website that the 2020 Rule was still in effect while EPA began a new
rulemaking effort. See Question 5 of the "Q&A on EPA's Intent to Revise 2020 Rule,"
available at https://w w w.eDa.gov/cvva~40l/aa~eDas~iriterit~revise~2020~rule ("5. Is the 2020
Clean Water Act Section 401 Certification Rule still in effect? Yes. The Clean Water Act
Section 401 Certification Rule is still in effect and will remain in effect until the Agency
finalizes a new regulation following the public notice and comment process.").

See the Agency's Response to Comments in Sections 13.1-13.3.

14. Economic Analysis

14.1 Claims Relative to 1971 and 2020 Rules

A commenter said that the Economic Analysis did not identify any instance in which the 2020 Rule's
request for certification provisions caused an adverse environmental or economic impact. One commenter
stated that EPA did not identify any adverse environmental impacts associated with the 2020 Rule
approach and did not identify any clearly beneficial environmental outcomes potentially attributable to
rescinding the 2020 Rule. Another commenter questioned whether any stakeholder had sufficient

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experience implementing the 2020 Rule after less than nine months of being in effect to provide feedback
warranting reconsideration.

A commenter added that the Economic Analysis claimed both that the proposed approach to the request
for certification would have positive environmental benefits relative to the 1971 Rule, because it would
support more consistency in a request for certification, and that it would have positive environmental
benefits relative to the 2020 Rule, because certifying authorities would be able to retain their own
requirements for a request for certification. The commenter claimed that these two points do not make
sense, because it means EPA is saying the proposal is environmentally beneficial because it is both more
and less prescriptive. This commenter also stated that through this economic analysis, EPA did not
articulate and justify the revisions to the 2020 Rule's provisions on requests for certification.

Agency's Response: EPA did not use a case study approach in the Economic Analysis for
the final rule due to the difficulty of representing the large variety and complexity of
projects subject to section 401 review and, thus, did not highlight any specific projects with
adverse environmental or economic impacts under the 2020 Rule. However, the Agency
strongly disagrees with commenter assertions that the 2020 Rule did not warrant
reconsideration. As discussed in Section III.C of the final rule preamble, EPA found, and
continues to find, it appropriate to revise the 2020 Rule for several reasons. First, the 2020
Rule does not represent the best statutory interpretation of fundamental concepts, such as
the scope of certification. See section IV.E of the final rule preamble for further discussion
on why the 2020 Rule's interpretation of the scope of certification is inconsistent with the
statutory text of section 401 and authoritative Supreme Court precedent interpreting that
text. Further, the 2020 Rule did not align with the broader water quality protection goals of
the Act or Congressional intent behind development and passage of section 401. The 2020
Rule also failed to appropriately address adverse impacts to state and Tribal water quality,
as evidenced in public comment. For example, commenters noted that use of the 2020
Rule's procedural requirements on certifications for the Corps' Nationwide General
Permits resulted in certifications with conditions or denials being treated as constructive
waivers. As discussed in section IV.F of the final rule preamble, the Agency recognizes that
a constructive waiver is a severe consequence; a waiver means that a Federal license or
permit that could adversely impact the certifying authority's water quality (i.e., cause
noncompliance with water quality requirements) may proceed without any input from the
certifying authority. See, e.g., section IV.E of the final rule preamble for further discussion
on the potential adverse water quality-related impacts of the 2020 Rule's interpretation of
the scope of certification.

The Agency disagrees that the impact assessments for revisions to the request for
certification provision, relative to the 1971 Rule and 2020 Rule baselines, "do not make
sense." The 1971 Rule did not define what is required in a "request for certification" when
states or Tribal governments are the certifying authorities. Since requests for certification
with insufficient information are a common problem, as noted in public comment and
stakeholder input, the final rule includes minimum requirements for all requests for
certification (see Section IV.C of the final rule preamble) to improve information

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consistency in requests for certification. However, unlike the 2020 Rule, the final rule
recognizes that it is reasonable that certifying authorities should be able to define what
information, in addition to a copy of the license or permit application and any water
quality-related materials that informed the development of the application (or draft general
permit or license and any water quality-related materials that informed the development of
the draft general license or permit for requests for certification on the issuance of a general
permit or license), is necessary to make an informed decision regarding protecting the
quality of their waters from adverse effects from a federally licensed or permitted activity.
Defining an exhaustive list of components for all requests for certification for all certifying
authorities could inhibit a comprehensive review under section 401 within the reasonable
period of time. The diverse nature of Federal licenses and permits, and the variety of
potential water quality impacts from those different types of activities, does not lend itself to
a one-size-fits-all approach. The minimum requirements help to improve information
consistency in requests for certification, while providing certifying authorities with
flexibility to define additional requirements beforehand that ensure they have the
information needed for effective section 401 reviews.

For each provision of the final rule, the Economic Analysis provides a brief overview and
justification for the revisions and describes potential economic impacts of the revision. For
a more detailed justification of the revisions to the 2020 Rule's provisions on requests for
certification, please see Section IV.C of the final rule preamble.

14.2 Data and Evidence

Another commenter said that the Economic Analysis is vague and did not provide any quantification of
costs or benefits for either the 1971 or 2020 Rule baselines. The commenter added that the short time
period that the 2020 Rule has been implemented makes EPA's claims a challenge to substantiate.
However, the commenter said that EPA has an obligation to make specific data or evidence to support its
finding that the 2020 Rule resulted in lower water quality, if it has that data or evidence. The commenter
stated that EPA needs to rectify its past record of all permitting processes conducted under section 401
and put procedures in place to track certifications moving forward.

Agency's Response: The Agency disagrees with commenter assertions that the Economic
Analysis is vague or that a qualitative analysis is problematic. The Economic Analysis
includes a careful qualitative assessment of potential impacts under the final rule. The
qualitative analysis consisted of characterizing baseline conditions and identifying impacts
of the regulatory changes based on information shared in pre-proposal input letters and
public comments. The lack of a national-level dataset on section 401 certification reviews
and the short timeframe under which the 2020 Rule was in effect limited EPA's ability to
quantify the incremental impacts of the final rule. Although both baselines (1971 and 2020
Rules) include the requirement that the Federal agency notify EPA upon receipt of an
application for a Federal license or permit and a certification, the Agency has historically
only received copies of the application and certification when EPA is the permitting Federal
agency or is acting as the certifying authority. Thus, the Agency does not have

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comprehensive data to estimate the number of certification decisions (grant, grant with
conditions, deny, or waive) per year, nor does the Agency have data to suggest how these
decisions will change under the final rule. Given these data limitations, the Agency
completed a careful qualitative assessment in accordance with Federal guidance for
conducting an economic analysis as described in Executive Order 12866: "Costs and
benefits shall be understood to include both quantifiable measures (to the fullest extent that
these can be usefully estimated) and qualitative measures of costs and benefits that are
difficult to quantify, but nevertheless essential to consider." Circular A-4 also states that,
although quantitative estimates of benefits and costs are preferrable when feasible for ease
of comparison across potential regulatory options, "some important benefits and costs (e.g.,
privacy protection) may be inherently too difficult to quantify or monetize given current
data and methods. You should carry out a careful evaluation of non-quantified benefits and
costs." (U.S. Office of Management and Budget, 2003) Thus, the absence of quantification
does not mean that the Economic Analysis does not support a reasoned determination of the
final rule.

EPA agrees that procedures would be helpful to track section 401 certifications moving
forward. Final rule revisions related to the neighboring jurisdictions process will provide an
opportunity for obtaining information about future section 401 certifications.

14.3 Information Collection Request

A commenter said that the hourly burden estimate for how long a project proponent will spend on a

request for certification is flawed, because: 1) four hours is likely low due to the proposed open-ended

request for certification provisions and 2) four hours is the same burden EPA estimated under the 2020

Rule, which they argued is not a reasonable assumption.

Agency's Response: EPA disagrees with both of the commenter's points. First, the Agency
disagrees that the request for certification provision is open-ended. The final rule identifies
minimum contents for all requests for certification. Additionally, the final rule provides
important limiting principles for additional contents in a request for certification, such as
emphasizing that additional contents must be water quality-related and identified prior to
when the request for certification is made. Second, the Agency maintains that the same
average hourly burden as under the 2020 Rule is reasonable, because it is an average
estimate and the final rule includes similar levels of requirements as the 2020 Rule (e.g.,
pre-filing meeting requests, minimum contents of requests for certification) with some
added flexibility. Additionally, the minimum contents in a request for certification should
be readily available and already developed as part of the license or permit application
process. Furthermore, not all requests for certification will involve the same associated
burden. The requests for certification for small projects can be prepared by the project
proponent with relatively little associated burden. The requests for certification for larger,
more complex projects may require significantly more associated burden to prepare.

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14.4 Input Received in Prior Rulemakings

14.4.1 Input on the 2019 Proposed Rule

This sub-topic summarizes comments that were made on a previous proposed rulemaking and were
resubmitted by commenters in the docket for the 2022 proposed rule.

One commenter asserted that in its 2019 proposed rule Economic Analysis, EPA acknowledged that the
2019 proposed rule would cause uncertainty and delays, especially for complex projects that require a
longer timeframe for review, because the narrower scope and shorter time for review could result in the
issuance of more denials of certification based on lack of information. The commenter concluded that this
would also cause more litigation and lengthy appeals.

A few commenters argued that the 2019 proposed rule's Economic Analysis did not accurately describe
the impacts and benefits of the 2019 proposed rule's changes. One commenter argued that EPA did not
follow its own Guidelines for Preparing Economic Analysis in preparing the 2019 proposed rule's
economic analysis concerning a general effect-by-effect approach to benefit analysis. The commenter
stated that EPA failed to meaningfully consider the challenges associated with the 2019 proposed rule in
the Economic Analysis because the Agency did not identify "major effects," "benefit categories," and
"significant endpoints" or "values"; therefore, the commenter concluded that the 2019 proposed rule was
arbitrary and capricious for failing to consider important aspects of the rulemaking.

Another commenter reacting to the 2019 proposed rule Economic Analysis expressed concern that EPA
had not drawn a rational connection between the facts found and the choices made. The commenter
asserted that the data in the 2019 proposed rule's Economic Analysis does not support the Agency's
position that Section 401 places a hinderance on development because over 95% of the CWA Section 404
permits issued by the Corps are general permit authorizations, so the majority of projects subject to
Section 401 do not require individual-level review. The commenter noted that EPA's 2019 proposed rule
Economic Analysis used case studies involving FERC-licensed projects which the commenter asserted
means that the regulatory revisions were being driven by a handful of energy project. Furthermore, the
commenter stated that the 2019 proposed rule's Economic Analysis had not included any economic
impacts and benefits from the avoidance of degradation of water resources because good water quality
supports public health and many outdoor industries. The commenter concluded that it is both unwise and
inappropriate to upend a well-crafted system of cooperative federalism that has given states and Tribes
power to protect aquatic habitat and waters for nearly a half-century due to frustration over a small
number of controversial projects.

Agency's Response: See Section 14.1-14.3 in the Agency's Response to Comments. Although
the case study approach used in the Economic Analysis for the 2020 Rule was helpful for
illustrating some of the issues under the 1971 Rule framework, the Agency agrees that it did
not provide a representative assessment of the section 401 review process as a whole. In the
Economic Analysis for the final rule, EPA did not include any case studies due to the
difficulty of representing the full spectrum of projects subject to section 401 review.

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15. Rulemaking Process

15.1 Rulemaking Process - General

15.1.1 Reconsideration of the 2020 Rule

Some commenters expressed support for reconsideration of the 2020 Rule and encouraged EPA to
finalize a new rule. Many of these commenters urged EPA to expedite the new rulemaking process, and
some of these commenters asserted an expeditious rulemaking process is needed to reduce harm and
uncertainty caused by the 2020 Rule. One commenter recommended that EPA repeal the 2020 Rule and
asked EPA to clarify in the new rule that if any or all of the final new rule is stayed or vacated by a court,
the 1971 Rule would come back into effect rather than the 2020 Rule.

A number of commenters who wrote in general support of the proposed rule requested that EPA move
quickly to implement the proposed rule and/or expressed a sense of urgency to repeal the 2020 Rule. In
many cases, commenters connected that urgency to purported harm(s), such as a narrowed scope of
review, caused by the 2020 Rule. Most, but not all, of these commenters also critiqued the 2020 Rule.

Some commenters opposed reconsideration of the 2020 Rule. Many of these commenters asserted that
EPA did not provide a basis for reconsideration of the 2020 Rule. One commenter argued that neither
Executive Order (E.O.) 13990 nor the "Fact Sheet: List of Agency Actions for Review" identified any
specific problems with the 2020 Rule. The commenter further asserted that the "Notice of Intention to
Reconsider and Revise the Clean Water Act Section 401 Certification Rule" and the proposed rule only
offered vague reasons for reconsideration of the 2020 Rule. One commenter asserted that the "Notice of
Intention to Reconsider and Revise the Clean Water Act Section 401 Certification Rule" failed to mention
"well-documented abuses" that preceded the 2020 Rule or EPA's determination in the 2020 Rule that
"some certifying authorities [had] implemented water quality certification programs that exceed the
boundaries set by Congress in section 401. 85 FR 42215. Another commenter noted that many of EPA's
proposed revisions fail to consider improper certification actions that the 2020 Rule addressed.

One commenter asserted that it was unnecessary for EPA to revise the 2020 Rule, because the 2020 Rule
is currently in litigation. The commenter asserted that EPA's proposal was in tension with ongoing
litigation, a misallocation of public resources, and reminiscent to EPA's actions regarding the Clean
Power Plan.

Agency's Response: The Agency appreciates commenter support for the proposed rule and
appreciates commenter requests for an expeditious rulemaking process. In finalizing the
proposed rule, the Agency reviewed and considered approximately 27,000 comments
received on the proposed rulemaking from a broad spectrum of interested parties.
Commenters provided a wide range of feedback on the proposal, including the substantive
and procedural aspects of the certification process, how the proposed rule would impact
stakeholders, and the legal basis for the proposed rule. The Agency discusses comments
received and responses in the applicable sections of the preamble to this final rule.

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EPA disagrees that it did not provide a basis for reconsideration of the 2020 Rule or that
litigation on the 2020 Rule made the rulemaking effort unnecessary. EPA proposed the
replacement rule only after reviewing the statutory text, legislative history, case law, and
public comments. EPA found, and continues to find, it appropriate to revise the 2020 Rule
for several reasons. First, the 2020 Rule does not represent the best statutory interpretation
of fundamental concepts, such as the scope of certification. See section IV.E of the final rule
preamble for further discussion on why the 2020 Rule's interpretation of the scope of
certification is inconsistent with the statutory text of section 401 and authoritative Supreme
Court precedent interpreting that text. Further, the 2020 Rule did not align with the
broader water quality protection goals of the Act or Congressional intent behind
development and passage of section 401. The 2020 Rule also failed to appropriately address
adverse impacts to state and Tribal water quality, as evidenced in public comment.15 See
e.g., section IV.E of the final rule preamble for further discussion on the potential adverse
water quality-related impacts of the 2020 Rule's interpretation of the scope of certification.
Accordingly, EPA is now finalizing revisions to the 2020 Rule to be fully consistent with the
1972 and 1977 CWA amendments, the Agency's legal authority, and the principles outlined
in Executive Order 13990.

15.1.2 Stakeholder Engagement and Opportunity for Public Comment

Some commenters expressed appreciation for EPA's engagement with states and other stakeholders
throughout the rulemaking process and commended the efforts EPA took to consider stakeholder
feedback in developing the proposed rule.

Some commenters requested that EPA continue to engage with states and Tribes and other stakeholders
throughout the rule development process. These commenters expressed a variety of reasons for continued
engagement, such as ensuring a rule that eliminates ambiguity, communicating stakeholder issues and
concerns, balancing a variety of land and water uses, and ensuring protection of state waters, habitat, and
communities. Some commenters observed room for improvement in the proposed rule and the need for
EPA to engage stakeholders further to improve the final rule. One commenter encouraged EPA to hold a
series of interactive meetings with co-regulator states and Tribes to discuss key issues, including
implementation challenges and opportunities. The commenter recommended interactive meetings at both
the national level and between EPA regions and their relevant states and Tribes.

In voicing support for the proposed rule and/or critiquing the 2020 Rule, several commenters discussed
stakeholder engagement in general. Most of these commenters expressed appreciation for the stakeholder
engagement and outreach process and/or opportunity to comment, with a few commenters specifically
mentioning outreach to states and/or Tribes.

15 For example, commenters noted that use of the 2020 Rule's procedural requirements on certifications
for the Corps' Nationwide General Permits resulted in certifications with conditions or denials being
treated as constructive waivers. As discussed in section IV.F in this preamble, the Agency recognizes that
a constructive waiver is a severe consequence; a waiver means that a Federal license or permit that could
adversely impact the certifying authority's water quality (i.e.. cause noncompliance with water quality
requirements) may proceed without any input from the certifying authority.

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Several of these commenters expressed appreciation for EPA incorporating their previous comments (e.g.,
on the 2020 Rule), including for example, regarding: scope of certification (e.g., state's authority, activity
as a whole), reasonable period of time, Tribal sovereignty, and collaborative federalism.

Some commenters argued that EPA failed to provide adequate notice and opportunity to comment on the
proposed rule. One commenter stated that the numerous requests for comment about regulatory options in
the proposed rule, involving numerous possible combinations of provisions, made it difficult to comment.
The commenter said EPA should provide another opportunity for comment after the Agency has a more
firm proposed rule in mind.

Agency's Response: The Agency appreciates commenter support for EPA's engagement
during the rulemaking. See Section III.D of the final rule preamble for further discussion
on stakeholder engagement during this rulemaking process.

EPA strongly disagrees with commenters asserting that the Agency failed to provide
adequate notice and opportunity to comment on the proposed rule. On June 9, 2022, the
Agency published the proposed rulemaking in the Federal Register, 87 FR 35318, which
initiated a 60-day public comment period that lasted through August 8, 2022. EPA held a
virtual public hearing on July 18, 2022, and hosted a series of stakeholder listening sessions
throughout June 2022, including one listening session for project proponents on June 14,
2022, three listening sessions for States and territories on June 15, 22, and 28, 2022, and
three listening sessions for Tribes on June 15, 22, and 28, 2022. The Agency also hosted a
Federal agency listening session on June 14, 2022. In finalizing the proposed rule, the
Agency reviewed and considered approximately 27,000 comments received on the proposed
rulemaking from a broad spectrum of interested parties. Commenters provided a wide
range of feedback on the proposal, including the substantive and procedural aspects of the
certification process, how the proposed rule would impact stakeholders, and the legal basis
for the proposed rule. The Agency discusses comments received and responses in the
applicable sections of the preamble to this final rule. The APA requires agencies to "give
interested persons an opportunity to participate in the rule making through submission of
written data, views, or arguments with or without opportunity for oral presentation." 5
U.S.C. 553(c). The APA does not specify a minimum number of days for accepting
comments on a proposed rule. The Agency complied with its obligation under the APA to
provide a reasonable length of time for interested parties to comment on the proposed rule.
Moreover, a pre-publication version of the proposed rule was posted on the EPA's website
on June 2, 2022, which was 7 days prior to its publication in the Federal Register and the
date the public comment period began.

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15.2 Executive Orders/Statutory Requirements

15.2.1 Regulatory Flexibility Act

A few commenters asserted that EPA improperly certified the proposed rule under the Regulatory
Flexibility Act (RFA). The commenters recommended that EPA include more qualitative discussion of
the impact of various features of the proposed rule on small entities, even if EPA is unable to quantify the
impacts. A commenter asserted that the proposed rule replaces the regulatory certainty of the 2020 Rule
with regulation by more than 50 certifying authorities and regulation by litigation.

One commenter described the requirements of the RFA, including the requirement to include a response
to written comments in any explanation or discussion accompanying the final rule's publication in the
Federal Register. The commenter stated that for all rules that are expected to have a significant economic
impact on a substantial number of small entities, Federal agencies are required by the RFA to assess the
impact of the proposed rule on small entities and to consider less burdensome alternatives. The
commenter asserted that because EPA failed to analyze the impact of requiring small entities to obtain
and submit draft Federal licenses and permits as part of a certification request, EPA did not provide a
comprehensive factual basis to certify that there will not be a significant impact on a substantial number
of small entities as required by section 605(b) of the RFA. Of the five provisions of the proposed rule that
may have an impact on small entities (i.e., pre-filing meeting request process, contents of a request for
certification, scope of water quality certification, modifications, and section 401(a)(2) process), the
commenter suggested that EPA did not provide a quantitative analysis, nor did include a qualitative
summary of the impacts on small entities relating to the contents of a request for certification. Citing
Section 4 of EPA's Economic Analysis for the Proposed Rule, the commenter highlighted EPA's position
that requiring a copy of a draft Federal license or permit "may postpone when the section 401 review
process could begin." The commenter concludes that delays of project approvals will increase costs for
regulated small entities, so EPA should prepare and publish an initial regulatory flexibility analysis.
Another commenter also asserted that the requirement for a draft license or permit implicates costly delay.

Agency's Response: EPA disagrees with commenter assertions that the Agency improperly
certified the rule under the RFA. As an initial matter, the Agency disagrees that it must
conduct a quantitative analysis to certify no significant impact on a substantial number of
small entities (SISNOSE). RFA Section 605(b) does not require an in-depth analysis for a no
SISNOSE certification, but rather "a statement providing a factual basis for such
certification." RFA does not say the factual basis must include data analysis, interviews, or
detailed industry analysis. The Agency finds that its analysis in this final rule provides a
factual basis for the Agency's certification of no SISNOSE and notes that changes in this
final rule are responsive to input from small industry entities and representatives. For
example, the Agency made changes in the minimum contents for a request for certification
in response to comments, including comments from small industry entities and
representatives, and eliminated the requirement for a draft license or permit in a request
for certification on an individual license or permit.

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Despite EPA not being able to quantify the impacts on small entities due to significant data
limitations, EPA has included a qualitative assessment of the potential impacts of the
rulemaking on project proponents that are small entities in the Economic Analysis for the
Final Rule. Based on the qualitative analysis, the Agency has determined that some small
entities may experience some impact from the rulemaking but that the impact would not be
significant, nor would the number of small entities be substantial. Please see Section 7.4 of
the Economic Analysis for the Final Rule for an in-depth, qualitative analysis of potential
impacts of the final rule on project proponents that are small entities.

15.2.2 Executive Order 13132: Federalism

One commenter expressed support for the proposed rule because the proposed rule reverses much of the
2020 Rule and significantly expands the authority of States and Tribes to review, condition, and approve
or deny certifications. The commenter noted that CWA guidance, implementation regulations, and court
interpretations supported the role of certifying authorities in the implementation of the CWA, in contrast
to the 2020 Rule which narrowed the authority of States and Tribes to deny Section 401 certifications, in
part by limiting the time frame for review and the scope of conditions that certifying authorities could
impose on Federal permits. The commenter appreciated the restoration of certifying authority in the
proposed rule's specified timeline for certification review, scope of review, and requirements for
certification.

Another commenter asserted that EPA's determination that the proposed rule does not have federalism
implications is misplaced because there is a well-documented history of certain States abusing their CWA
authority to effectively block projects in other States for non-water quality reasons. Since EO 13132
requires EPA to "closely examine the constitutional and statutory authority supporting any action that
would limit the policymaking discretion of the States and shall carefully assess the necessity for such
action," the commenter concluded that the abusive use of CWA certifying authority to block projects in
other States on non-water quality reasons inherently limits the policymaking discretion of the State in
which the blocked project would be located. The commenter recommended that EPA acknowledge as
much and perform the appropriate analysis under EO 13132.

Agency's Response: Under the technical requirements of Executive Order 13132 (64 FR
43255, August 10,1999), EPA has determined that this rulemaking does not have federalism
implications but expects that this rulemaking may be of significant interest to state and
local governments. Consistent with EPA's policy to promote communication between EPA
and state and local governments, EPA conducted outreach and engagement with state and
local government officials and representatives prior to the finalization of this rule to permit
them to have meaningful and timely input into its development. Please see Section VI.E of
the final rule preamble for further discussion on EPA's outreach and engagement with state
and local government officials and representatives on this rulemaking and how this
rulemaking may impact states.

In response to the comment regarding state usage of water quality certifications for non-
water quality reasons, the Agency notes that based on commenter feedback and EPA's

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experience implementing section 401, EPA finds that the vast majority of certification
decisions are based entirely on water quality considerations. Nevertheless, the final rule
reiterates that certifying authorities are limited to considering the water quality-related
impacts from an activity when determining whether to issue a section 401 certification. See
Section IV.E of the final rule preamble and Section 5 in this Response to Comments
document for further discussion on the scope of certification.

15.2.3	Executive Order 13175: Tribal Consultation

One commenter reserved the right to request government-to-government consultation and provide
additional input beyond the public comment period as they deem necessary. Another commenter
recommend that EPA hold additional Tribal information sessions and offer Tribal consultation
opportunities prior to finalizing the rule.

One commenter argued that EPA did not adequately consult with Tribes before developing the proposed
rule, thereby not acting consistently with its Federal agency trust responsibility, emphasizing the proposed
rule's impacts on water resources and therefore treaty-reserved rights.

Agency's Response: EPA disagrees with the commenter asserting that the Agency did not
adequately consult with Tribes. EPA consulted with Tribal officials under the EPA Policy
on Consultation and Coordination with Indian Tribes early in the process of developing this
rulemaking to allow them to have meaningful and timely input into its development. EPA
has developed a final Summary Report of Tribal Consultation and Engagement for the
Clean Water Act Section 401 Water Quality Certification Improvement Rule, which further
describes EPA's efforts to engage with Tribal representatives and is available in the docket
for this rulemaking. As required by section 7(a), EPA's Tribal Consultation Official has
certified that the requirements of the executive order have been met in a meaningful and
timely manner. A copy of the certification is included in the docket for this action. For
further discussion on the tribal consultation and coordination process on this final rule,
please see Section VI.F of the final rule preamble.

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

One commenter suggested that EPA's certification without explanation that the proposed rule is not a
'significant' energy action is inappropriate given the domestic and geopolitical issues discussed in their
public comment letter. The commenter stated that the proposed rule is irrational for not including
discussion of the requirement to consider energy impacts in the economic analysis and the proposed rule
preamble. The commenter asserted that EPA cannot evade the simple fact that its proposal would provide
more opportunities for extending the deadline for their consideration and for modifying a certification
after it is issued and broaden the scope of aspects of the project and aspects of state or Tribal law which
certifying authorities could bring to bear when considering certification requests, which the commenter
argued will inevitably increase uncertainty, delay, burden, and in many cases may lead to de facto denial
of needed energy and other infrastructure projects.

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Agency's Response: Some Federal licenses and permits that relate to the supply and
distribution of energy, such as Federal construction and operation licenses or permits, are
subject to CWA section 401 certification if the activity may result in a discharge into waters
of the United States. However, this rulemaking does not impact existing federally licensed
or permitted projects - except for making it easier to modify elements of a previously issued
grant of certification. As discussed in the Economic Analysis for the Final Rule, EPA
anticipates that this final rule will improve the efficiency of the certification review process
for new requests for certification, which will support efficiency in the related Federal license
or permit review processes. Therefore, there are no direct impacts from this rulemaking on
the supply, distribution, or use of energy, and any indirect impacts of this final rule will be
neither adverse nor significant on the supply, distribution, or use of energy.

The Agency also disagrees with the commenter's assertion that the rule will delay or
bringing uncertainty to infrastructure projects. See Section 16.3 of the Agency's Response
to Comments for further response to comments on the proposed rule and infrastructure
projects.

15.2.5 Executive Order 12898: Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations; Executive Order 14096:
Revitalizing Our Nation's Commitment to Environmental Justice for All

One commenter highlighted EO 13990 and the importance of restoring the broad authority of States and,
in particular, Tribes under Section 401 to ensure clean water, water quality, public health, protection of
the environment, and aquatic habitat is secured for environmental justice communities. A few
commenters recommended that EPA prioritize environmental justice and address disproportionate harm
to communities of color and low-income communities and concerns about climate change - which poses
immense threats to state and Tribal waters.

Agency's Response: The Agency recognizes that the burdens of environmental pollution
disproportionately fall on certain communities with environmental justice concerns, and
EPA is responsive to environmental justice concerns through multiple provisions in this
rule. See Section VI. J of the final rule preamble and Section V of the Economic Analysis for
the Final Rule for further discussion on environmental justice and this final rule.

15.3 Input Received in Prior Rulemakings

15.3.1 Input on the 2019 Proposed Rule

This sub-topic summarizes comments that were made on a previous proposed rulemaking and were
resubmitted by commenters in the docket for the 2022 proposed rule.

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Administrative Procedure Act

Multiple commenters argued that the 2019 proposed rule, if finalized, would violate the APA because of
the expedited consultation did not provide adequate public notice and comment opportunity. Some of the
commenters asserted that the Agency did not conduct enough outreach before issuing the 2019 proposed
rule, which lead to the development of a flawed 2019 proposed rule. A few commenters stated that the
2019 proposed rule did not heed, acknowledge, or respond to the early input that they had provided when
EPA began the 2019 rulemaking process.

One commenter recommended that EPA provide additional guidance upon completion of the 2019
rulemaking and rescind the 2019 Guidance after the final rule on the 2019 proposed rule is issued.

One commenter recommended that EPA hold additional state and Tribal listening sessions or workshops
throughout development of the 2019 proposed rulemaking.

One commenter recommended that EPA host more than one public hearing because the proposed rule
focused on actions of states like NY, but the one public hearing was held on the other side of the country
in Salt Lake City, UT.

One commenter asserted that because of EO 13868, EPA initiated the section 401 rulemaking in 2019 for
purely political reasons rather than conducting the appropriate administrative and deliberative processes
that should proceed the development of a rulemaking.

One commenter described the 2019 CWA section 401 rulemaking process in similar terms to the
circumstances in New York v. U.S. Department of Labor, 363 F. Supp. 3d 109 (D.D.C. 2019), in which
the Department of Labor implemented an executive order to undo the Affordable Care Act before the
court said their action, "scraps [Employment Retirement Income Security Act]'s careful statutory
scheme" and "exceeds the statutory authority delegated by Congress." Id. at 117-118. The commenter
concluded that EPA's 2019 proposed rule needed to be withdrawn as the rulemaking represented a pre-
determined attempt to overturn decades of Agency practice and elevate the interests of developers over
the water quality interests of state and Tribal certifying authorities.

One commenter argued that the 2019 proposed rule will violate the APA by failing to: (1) consider and
analyze relevant issues, including the CWA's overarching objective to restore and maintain water quality;
and (2) provide a reasoned explanation or rational basis for EPA's decision to repeal the existing section
401 regulations without consideration of the states' significant reliance on the existing regulations.

One Federal Decision

One commenter argued that EPA's 2019 proposed rule is at odds with the One Federal Decision
Executive Order. The commenter asserted that states and Tribes told EPA during pre-proposal
consultation that states and Tribes lack the staff needed to run their section 401 programs already. The
commenter asserted that the 2019 proposed rule could potentially lead to increased denials of certification
if a certifying authority does not have adequate information to make their decision. Furthermore, the

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commenter recommended that EPA provide an opportunity for all certifying authorities to participate in
pre-application coordination.

Executive Order 13175: Tribal Consultation

In response to the 2019 proposed rule, one Tribal nation stated that EPA did not adequately consult with
their nation prior to developing the 2019 proposed rule. The commenter stated that the Federal
government is required to preserve Tribal resources (such as fish stocks) - which the Supreme Court has
characterized as a duty that should be judged by "the most exacting fiduciary standards." Seminole Nation
v. U.S., 316 U.S. 286, 296-297 (1942). Because of the Federal government's trust obligation, the
requirements under Executive Order 13175, and guidance in EPA's Policy on Consultation and
Coordination with Indian Tribes, the commenter argued that consultation "the process of meaningful
communication and coordination," should be conducted "early enough to allow tribes the opportunity to
provide meaningful input" on the proposed action. However, the commenter concluded that EPA did not
offer enough opportunity for the Tribe to provide substantive input either during the public hearing or the
webinars on the 2019 proposed rule and therefore should engage in direct consultation with the Tribe.

Agency's Response: EPA reviewed the 2020 Rule in accordance with Executive Order 13990
and, in the spring of 2021, determined that it would propose revisions to the 2020 Rule
through a new rulemaking effort. See Notice of Intention to Reconsider and Revise the
Clean Water Act Section 401 Certification Rule, 86 FR 29541 (June 2, 2021). EPA
considered several factors in making this determination, including but not limited to the
text of CWA section 401; Congressional intent and the cooperative federalism framework of
CWA section 401; concerns raised by stakeholders about the 2020 Rule, including
implementation-related feedback; the principles outlined in the Executive Order; and issues
raised in litigation challenging the 2020 Rule. Id. In particular, the Agency identified
substantial concerns about whether portions of the 2020 Rule impinged on the cooperative
federalism principles central to CWA section 401. The Agency identified this and other
concerns as they related to different provisions of the 2020 Rule, including certification
requests, the reasonable period of time, scope of certification, certification actions and
Federal agency review, enforcement, and modifications. See id. at 29543-44.

See the Agency's Response to Comments in Sections 15.1-15.2.

15.3.2 Pre-proposal Input from 2021

This sub-topic summarizes input that was received prior to the 2022 proposed rule and was resubmitted
by commenters in the docket for the 2022 proposed rule.

Executive Order 12898

In response to EPA's NOI to reconsider and revise the 2020 Rule, one stakeholder asked that EPA correct
the mistakes of the 2020 Rule and ensure that a new rule is developed with adequate consideration for

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environmental justice. The stakeholder argued that the 2020 Rule resulted in a real and significant
disparate impact on Tribes, communities of color, and low-income families.

Rulemaking Process

In response to EPA's NOI to reconsider and revise the 2020 Rule, one stakeholder recommended that
EPA work with the Army Corps to develop, and publish for comment, interim guidance regarding
implementation of the 2020 Rule to provide states with the time, information and flexibility they need to
make certification decisions within the limits of the statute. The stakeholder recommended that EPA
engage with states as co-regulators for the review of any potential Agency action before it is published for
public comment.

Agency's Response: See the Agency's Response to Comments in Sections 15.1-15.2; see also
Section III.D of the final rule preamble for further discussion on the Agency's stakeholder
outreach.

The Agency would also like to clarify that this rulemaking effort is not a joint rulemaking.
EPA is the Federal agency tasked with administering and interpretating the CWA, see 33
U.S.C. 1351(d), 1361(a), including section 401.

16. General

16.1 General input on the 2020 Rule and 1971 Rule

16.1.1 General input on the 2020 Rule
Oppose 2020 Rule

Approximately half of the commenters who wrote in general support of the proposed rule critiqued the
2020 Rule. Many of these commenters discussed environmental harm(s) and/or lack of protection(s) that
they argued resulted from the 2020 Rule. For example, a couple of commenters provided detailed
discussions of specific projects that they argued had caused harm under the 2020 Rule, including the
following: Brunswick Harbor Dredging, Georgia; Riverport Development, South Carolina; U.S. 278
Corridor Improvements, South Carolina; and Conowingo Hydroelectric project, Susquehanna River.

Some commenters claimed that the 2020 Rule favored economic interests over environmental and/or
public health concerns. A commenter asserted that the 2020 Rule was driven by a few projects and
upended a half century of continuity of regulatory practice and stripped state and Tribal authority over
thousands of projects each year in contravention of the statutory language and Supreme Court precedent.
A number of commenters critiqued the 2020 Rule for being inflexible, cumbersome, and/or ineffective,
and a number of commenters characterized the 2020 Rule as illegal and/or subject to litigation. One
commenter stated that the 2020 Rule exacerbated confusion and uncertainty and led to litigation and
certification denials.

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Several commenters asserted that prior to the 2020 Rule, the section 401 process worked as Congress
intended for fifty years and disagreed with assertions that states had used their authority to block
development. Similarly, another commenter noted that thousands of certification applications were
reviewed yearly over the last 50 year and that the vast majority were granted without incident, and that
the 2020 Rule departed from prior rules and went against the text and purpose of the CWA and curtailed
state and Tribal authority to protect their waters.

One commenter requested that EPA should clearly state that the 2020 Rule's interpretations of section
401 contravene the text and purpose of the CWA, including the 2020 Rule's approach to the reasonable
period of time, scope of certification, Federal agency review, enforcement, and modification. The
commenter asserted that while the proposal included explicit and implicit admission that the 2020 Rule
was unlawful, the proposal equivocated that the 2020 Rule might be legally permissible where it casts the
rulemaking as a discretionary change in policy. The commenter further argued that such equivocation was
confusing because if the 2020 Rule is inconsistent with principles of cooperative federalism central to
section 401, then it cannot be consistent with the CWA. Instead, the commenter recommended that the
Agency should clearly state that a number of the 2020 Rule's key components are unlawful, asserting that
EPA is legally required to do so and would be beneficial in defending a final rule in future litigation.

Qualified Support for 2020 Rule

A few commenters who expressed support for the proposed rule also expressed support for elements of
the 2020 Rule. One commenter conveyed appreciation for the proposed rule incorporating elements of the
2020 Rule that the commenter characterized as increasing the certification process' clarity and efficiency.
For example, one commenter critiqued the 2020 Rule in terms of timing, scope, and Federal agency roles
with regard to certification conditions and denials and wrote in support of clarifications in the proposed
rule. However, this commenter also argued in favor of maintaining some elements of the 2020 Rule in
order to not overburden the farming and food production sectors, including fishing, especially in the
context of global population growth and the need for drinking water protection. Another commenter
voiced support for the proposed rule as being more consistent with the Clean Water Act and critiqued the
2020 Rule, but also recommended the proposed rule provide better guidance on what is not federally
regulated, which the commenter argued the 2020 Rule did in a clear manner.

Support 2020 Rule

Conversely, many of the commenters who did not support the proposed rule voiced support for the
entirety or certain aspects of the 2020 Rule. Generally, these commenters asserted that the 2020 Rule
addressed specific issues better than the proposed rule. For example, one commenter asserted that the
2020 Rule defined the procedures, timeframes, and scope of Section 401 in a clear and specific manner. A
couple commenters voiced support for the 2020 Rule's approach to timeframes, arguing that these
approaches in the 2020 Rule would prevent the Section 401 process from indefinitely slowing down
infrastructure projects, including hydropower projects and pipelines. One commenter voiced support for
the 2020 Rule in providing a balance between water quality protection compliance and project
proponents.

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A number of the commenters who voiced support for the 2020 Rule raised concerns about states
improperly applying Section 401, argued against too broad a scope of certification, and/or called for
limiting state authority. A few commenters asserted the 2020 Rule addressed problems caused by
misinterpretations of the statute that led to vetoing projects for non-water quality reasons. One commenter
asserted that section 401 is not the only means by which states and Tribes may protect water quality or
other concerns, arguing that neither section 401 nor the 2020 Rule limited the authority of states or Tribes
to regulate any activity under state or Tribal law, other Federal laws, and other provisions of the CWA.
Another commenter argued that the proposed rule would be improved if EPA included limitations on
states' certifying authority. This commenter warned that a lack of these limitations could lead to social
and environmental consequences; overtake Federal jurisdiction; more frequently cause licenses or
permittees to decommission or abandon projects where certifications conditions' costs exceed project
benefits. This commenter further argued that the proposed rule's changes from the 2020 Rule that
purportedly broaden the scope of certification would remove efficiencies from the 2020 Rule, thereby
increasing costs and potentially resulting in substantial job losses.

Agency's Response: EPA has considered these diverse comments and discussed the
Agency's rationale for regulatory revisions to the 2020 Rule throughout the final rule
preamble, in this Response to Comments document, and in the Final Rule Economic
Analysis.

In the Agency's reconsideration of the 2020 Rule pursuant to Executive Order 13990, EPA
found multiple reasons to revise the 2020 Rule. First, the 2020 Rule does not represent the
best statutory interpretation of fundamental concepts, such as the scope of certification. See
section IV.E of the final rule preamble for further discussion on why the 2020 Rule's
interpretation of the scope of certification is inconsistent with the statutory text of section
401 and authoritative Supreme Court precedent interpreting that text. Further, the 2020
Rule did not align with the broader water quality protection goals of the Act or
Congressional intent behind development and passage of section 401. The 2020 Rule also
failed to appropriately address adverse impacts to state and Tribal water quality, as
evidenced in public comment.16 See e.g., section IV.E of the final rule preamble for further
discussion on the potential adverse water quality-related impacts of the 2020 Rule's
interpretation of the scope of certification.

EPA is finalizing revisions to the 2020 Rule to be fully consistent with the 1972 and 1977
CWA amendments, the Agency's legal authority, and the principles outlined in Executive
Order 13990. This final rule revises the 2020 Rule to better reflect the CWA's statutory
text, the legislative history regarding section 401, and the broad water quality protection
goals of the Act. In addition, the final rule clarifies certain aspects of section 401

16 For example, commenters noted that use of the 2020 Rule's procedural requirements on certifications
for the Corps' Nationwide General Permits resulted in certifications with conditions or denials being
treated as constructive waivers. As discussed in section IV.F in this preamble, the Agency recognizes that
a constructive waiver is a severe consequence; a waiver means that a Federal license or permit that could
adversely impact the certifying authority's water quality (i.e.. cause noncompliance with water quality
requirements) may proceed without any input from the certifying authority.

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implementation that have evolved in response to over 50 years of judicial interpretation and
certifying authority practice, and it supports an efficient and predictable water quality
certification process that is consistent with the cooperative federalism principles central to
the CWA and section 401.

16.1.2 General input on the pre-2020 Rule regulatory regime

Oppose pre-2020 Rule

A couple of commenters asserted that the proposed rule was more consistent with the CWA and would
improve clarity by reflecting practices that have "evolved" since the 1971 Rule.

A few commenters voiced concern with the pre-2020 regulatory regime, including asserting that the pre-
2020 Rule regime was confusing and led to delays. A couple commenters expressed concern that the
proposed rule, or aspects of it, would re-create issues that existed prior to the 2020 Rule. A number of
commenters discussed scope of certification, including states' purported misuse of Section 401. Several
commenters wrote about the Section 401 regulations prior to the 2020 Rule and argued that states
blocked, modified, and/or delayed projects on grounds unrelated to water quality (according to
commenters, this included climate change, opposition to fossil fuels, air pollution, public health,
hydraulic fracturing, energy plans more broadly, sampling and monitoring requirements). These
commenters explicitly or indirectly appeared to voice support for the 2020 Rule and one other argued that
EPA action is needed to avoid this misuse. A couple commenters specifically discussed hydropower
projects and asserted that before the 2020 Rule, hydropower projects could be delayed for years, with
certifying authorities improperly expanding the scope of Section 401, usurping FERC authority, and
preventing license updates and preventing some projects from ever being financed or built.

Support pre-2020 Rule

In the context of critiquing the 2020 Rule and/or voicing general support for the proposed rule, a number
of commenters wrote favorably about the pre-2020 approaches and/or processes, including supporting a
return to those. Some characterized their support in terms of decades of longevity, consistency,
comprehensiveness, and/or clarity of the pre-2020 regulatory regime. One commenter voiced support for
EPA's intentions in the proposed rule, returning to pre-2020 approaches and grounding it in legal and
regulatory precedent but argued that the proposed rule also included practices beyond the CWA.

One commenter voiced support for EPA returning to pre-2020 approaches, arguing that the proposed rule
does that in some cases, but also raising concerns that the proposed rule goes beyond the CWA.

Agency's Response: EPA appreciates the comments in support of the proposed rule. The
Agency has discussed its rationale for regulatory revisions to the 2020 Rule and, where
appropriate and relevant, how the final rule compares to the 1971 Rule and pre-2020 Rule
practice throughout the final rule preamble, in this Response to Comments document, and
in the Final Rule Economic Analysis.

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The Agency views the final rule as consistent with the 1972 and 1977 CWA amendments
and considerate of longstanding practices since the 1971 Rule. The final rule clarifies
certain aspects of section 401 implementation that have evolved in response to over 50 years
of judicial interpretation and certifying authority practice, and it supports an efficient and
predictable water quality certification process that is consistent with the cooperative
federalism principles central to the CWA and section 401.

16.2 General input on CWA, Congressional Intent, and Cooperative Federalism

16.2.1 Consistency with Clean Water Act and Congressional Intent

In voicing general support for the proposed rule and/or critiquing the 2020 Rule, approximately half the
commenters also argued that the proposed rule was consistent with the CWA and/or Congressional intent
and/or more consistent than the 2020 Rule. These commenters framed consistency in terms of elements
such as statutory text, intent, purpose, and/or goals (e.g., "restore and maintain the chemical, physical, and
biological integrity of the Nation's waters"). Most of these commenters made that argument explicitly,
while others alluded to it by voicing support for consistency more generally. Many of these commenters
tied their comments about consistency with the CWA and Congressional intent to other themes discussed
throughout this summary, such as cooperative federalism, state authority, and water quality protection. A
few commenters characterized Section 401 as reflecting the CWA's intended balance between states and
projects, and states' or Tribes' water quality protections. Another commenter called for implementing the
proposed rule as part of strengthening the CWA to the maximum extent possible. Another commenter
suggested that the Agency should go further to ensure its rulemaking restores the ability of states to assure
Federal projects meet state requirements and are consistent with the CWA and Supreme Court precedent.
One commenter stated that Congress delegated authority to the EPA Administrator to develop regulations
to resolve gaps in the statutory text in a manner consistent with the statutory framework that and that the
proposed rule represented the Agency's exercise of that authority in a manner that recognized and restores
the balance of state, Tribal, and Federal authorities consistent with the cooperative federalism principles
central to CWA section 401.

A few commenters argued that the proposed rule was inconsistent with the CWA and/or congressional
intent in terms of cooperative federalism and a sense of overreach. A couple of commenters argued that
the proposed rule exceeded the language and/or requirements of Section 401. A different commenter said
that Congress did not delegate authority to EPA to interpret section 401 in regulations other than its own
roles.

A couple commenters argued that the 2020 Rule was consistent with Congress's intent with Section 401
and created a proper balance between state involvement, protection, and timing and certainty. One of
these commenters asserted that states have ample authority under the 2020 Rule to ensure consistency
with water quality requirements.

Several commenters asserted that Congress intended for states to have a primary responsibility in
addressing water pollution and in achieving the goals of the Act, citing to CWA sections 101(b) and 510.
These commenters argued that Section 401 was intended to fill a gap in the regulatory structure to ensure

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Federal licenses or permits complied with state laws to protect water quality. A few of these commenters
stated that Federal and state courts have found that state authority to deny or condition water quality
certifications is broad. One commenter further noted that as long as certification denials or conditions are
founded in protecting water quality or imposing other appropriate state law environmental considerations,
the decisions have been upheld by the courts as a valid exercise of state statutory authority.

A few commenters expressed concern that the proposed rule was at odds with Congressional intent and
would provide states with the power to stop projects without water quality justifications. Another
commenter asserted that the proposed rule interpreted cooperative federalism and the CWA too narrowly
and did not consider interest of other states (aside from the certifying state), such as those where energy is
produced or used. The same commenter argued that the CWA provides a balanced approach by which a
certifying state can only block a project under specific conditions defined in statute. One commenter
claimed that the proposed rule would lead to practices that are inconsistent with the CWA, such as state
misuse of Section 401.

Agency's Response: The Agency agrees with commenters asserting that the proposed rule
was consistent with the CWA and Congressional intent, and accordingly, disagrees with
commenters asserting that the proposed rule was inconsistent with the CWA and
Congressional intent. As discussed throughout the final rule preamble and this Response to
Comments document, the Agency is finalizing revisions to the 2020 Rule to be fully
consistent with the 1972 and 1977 CWA amendments, the Agency's legal authority, and the
principles outlined in Executive Order 13990. This final rule revises the 2020 Rule to better
reflect the CWA's statutory text, the legislative history regarding section 401, and the broad
water quality protection goals of the Act. In addition, the final rule clarifies certain aspects
of section 401 implementation that have evolved in response to over 50 years of judicial
interpretation and certifying authority practice, and it supports an efficient and predictable
water quality certification process that is consistent with the cooperative federalism
principles central to the CWA and section 401.

The Agency disagrees with the commenter asserting that the Agency does not have
authority to interpret section 401 in regulations. EPA is the primary agency responsible for
developing regulations and guidance to ensure effective implementation of CWA programs,
including section 401. See 33 U.S.C. 1251(d), 1361(a).

The Agency disagrees with commenters asserting that the 2020 Rule was consistent with
Congress's intent with Section 401. First, the 2020 Rule does not represent the best
statutory interpretation of fundamental concepts, such as the scope of certification. See
section IV.E of the final rule preamble for further discussion on why the 2020 Rule's
interpretation of the scope of certification is inconsistent with the statutory text of section
401 and authoritative Supreme Court precedent interpreting that text. Further, the 2020
Rule did not align with the broader water quality protection goals of the Act or
Congressional intent behind development and passage of section 401. The 2020 Rule also
failed to appropriately address adverse impacts to state and Tribal water quality, as

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evidenced in public comment.17 See e.g., section IV.E of the final rule preamble for further
discussion on the potential adverse water quality-related impacts of the 2020 Rule's
interpretation of the scope of certification.

The Agency also disagrees with the commenter asserting that the proposed rule would
provide states with the power to stop projects without water quality justifications. See
Section IV.E of the final rule preamble and Section 5 of the Agency's Response to
Comments for further discussion on the water quality limitations inherent to Section 401,
and as a result, this final rule. In response to the commenter asserting that the proposed
rule did not consider the interests of other states, aside from the certifying state, the Agency
observes that Section 401(a)(2) provides an opportunity for potentially affected jurisdictions
to object to the issuance of a Federal license or permit that will violate their water quality
requirements. See Section IV.K of the final rule preamble. Outside of this subsection,
section 401 does not provide an explicit role for other jurisdictions whose water quality in
not otherwise impacted by the Federally licensed or permitted activity. When a certifying
authority determines how it will act on a request for certification, section 401 is clear that
the certifying authority must determine whether the activity will comply with applicable
water quality requirements, and not whether it will impact another state's interest in energy
production or usage. See Section IV.E and F for further discussion on the scope of
certification and certification decisions.

16.2.2 Cooperative Federalism, Balance, and Similar Concepts

Many commenters voiced support for the proposed rule and/or critiqued the 2020 Rule in terms of
cooperative federalism, cooperation, partnership, balance and/or co-regulator relationship between states
and/or Tribes and the Federal government. Many of the commenters who discussed consistency with the
CWA framed their argument(s) around this theme. Some of these commenters appeared to draw directly
from the language of the proposed rule (e.g., preamble) in framing these discussions. Many of these
commenters connected arguments around cooperative federalism (or similar themes) to other themes, for
example, flexibility.

Most commenters who wrote generally in favor of the proposed rule - including a large number of those
who discussed cooperative federalism, consistency with the CWA, and similar themes - wrote in favor of
state, Tribal, and/or local roles in providing protections. One of these commenters asserted that states and
Tribes are most acutely aware of the unique threats facing their waters, claiming they know the pollutants
of concern, how climate change is already impacting their region, and what needs to be done to protect
the health and safety of their most vulnerable residents. A few commenters specifically cautioned that
Federal agencies may not be familiar with state laws and regulations around water quality and/or lack

17 For example, commenters noted that use of the 2020 Rule's procedural requirements on certifications
for the Corps' Nationwide General Permits resulted in certifications with conditions or denials being
treated as constructive waivers. As discussed in section IV.F in this preamble, the Agency recognizes that
a constructive waiver is a severe consequence; a waiver means that a Federal license or permit that could
adversely impact the certifying authority's water quality (i.e.. cause noncompliance with water quality
requirements) may proceed without any input from the certifying authority.

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local knowledge of ecosystems. One of these commenters asserted that restoring state and Tribal authority
over 401 decisions is essential for achieving environmental justice and provided a detailed example of a
proposed New York pipeline, claiming that this example illustrates that it is imperative for state and
Tribal authority to be restored in Section 401.

Some commenters wrote in favor of Tribal roles and protections and/or sovereignty in particular, with
some of them mentioning a history of unfavorable treatment of Tribal populations. Several of these
commenters discussed Tribes' stewardship role and encouraged listening to Tribes. A few of these
commenters discussed Tribal cultural values around natural resources. One commenter provided a
detailed discussion of Tribal treaty rights relevant to Section 401 and cited treaty rights and congressional
intent in support of certifying authorities. The commenter asserted that the 2020 Rule usurped Tribal
authority, providing detailed descriptions of the role of the Tribe in protecting waters and fishing rights
from pollution and climate change.

In slightly different arguments, a couple of commenters generally voiced support for the proposed rule
and critiqued the 2020 Rule, but also suggested additional support for state and Tribal authority, framing
this argument around cooperative federalism and the CWA's intent. After voicing support for the
proposed rule, compared to the 2020 Rule, including in terms of the CWA's federal-state balance, one of
these commenters requested that EPA include in the proposed rule additional flexibilities and
clarifications in order to fully address the federal-state balance. One commenter voiced support for
"meaningful, substantive, and early consultation" and working in collaboration with states.

A few commenters argued that the proposed rule was not consistent with cooperative federalism
principles because it ran counter to state authority under the CWA. One commenter argued that the
proposed rule expanded EPA authority beyond the bounds of the CWA. Another commenter argued that
the proposed rule seeks to define the form, substance, and timeline of state review, which runs counter to
states' authority under the CWA, and argued that states can best define procedures. Similarly, another
commenter argued that the proposed rule's certification process will impede certifying authorities'
regulatory abilities. Another commenter argued that the proposed rule did not adequately acknowledge
state primacy and failed to recognize state authorities under the CWA and other state programs that go
beyond Federal requirements. Similarly, another commenter argued that the CWA section 401 provided
authority to the states and allowed states to regulate beyond Federal standards. One commenter argued
that cooperative federalism, Federal-state balance, and Federal respect for state authority are key to the
CWA, and Section 401 changes do not supplant state authority and law. This commenter further wrote
that they would not support any reduction in states' roles or authorities. One commenter recommended
more autonomy for certifying authorities, for example allowing the certifying authority to define its own
request for certification process and requirements, decide the length of the reasonable period of time, and
enforce certification conditions.

Several commenters called for a sense of balance and/or consistency, between certifying authorities and
the Federal government and/or between water quality protections and advancing projects and other
concerns, such as economic, national, and energy interests. A few commenters expressed concern over
certifying authorities' use of section 401 or a broad interpretation of cooperative federalism. A couple
commenters raised concerns about certain projects being restricted in an unfair manner or delayed, with

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one commenter specifically pointing to states' and local jurisdictions' political agendas. One commenter
argued that the 2020 Rule adhered to cooperative federalism principles by preventing states from stopping
fossil fuel projects based on policy agendas as opposed to water quality standards. Another commenter
raised concerns about states' use of Section 401 and conflicts in cases where impacts cross state
boundaries. Another commenter raised concerns about decisions being left to states in situations where,
according to the commenter, the state has not demonstrated adequate capabilities, and cited Louisiana.

A few commenters asserted that the proposal would remove Federal authority, including one commenter
who asserted that the proposed rule would cede EPA authority to states, inconsistent with the Agency's
role and cooperative federalism, and another commenter who argued that Congress intended Federal
agencies to have the primary authority for decision-making and states a more limited role in Section 401.

Agency's Response: The Agency agrees with commenters that states and Tribes, as opposed
to Federal agencies, are the most knowledgeable of state and Tribal waters and their
applicable water quality requirements. As discussed above, this final rule supports an
efficient and predictable water quality certification process that is consistent with the
cooperative federalism principles central to the CWA and section 401. See the Agency's
Response to Comments in Section 16.2.1. The Agency disagrees with commenters asserting
that the final rule will impede certifying authority regulatory abilities or expand EPA's
authority. On the contrary, this final rule enshrines the cooperative federalism principles
central to section 401 while respecting the substantive and procedural guardrails Congress
intended. For example, several aspects of this final rule provide certifying authorities with
the ability to inform the certification process, e.g., pre-filing meeting requests, contents of a
request for certification, reasonable period of time, while at the same time recognizing the
need for predictable and transparent backstops. See the final rule preamble and the
Agency's Response to Comments document for further discussion on the Agency's rationale
for these and other final rule provisions.

The Agency appreciates commenter concerns regarding projects being restricted in an
unfair manner or delayed. As discussed above, this final rule supports an efficient
certification process that is grounded in the water quality protection goals central to the
CWA and section 401. For example, the final rule provides greater certainty around the
scope of certification by clarifying that a certifying authority's analysis of any given activity
is limited to adverse water quality-related impacts that may prevent compliance with water
quality requirements. Neither section 401 nor this final rule authorizes certifying
authorities to deny or condition a certification due to impacts from the activity that do not
adversely affect water quality. See Section IV.E of the final rule preamble and the Agency's
Response to Comments Section 5. As another example, the final rule clarifies that while
certifying authorities and Federal agencies may jointly set the reasonable period of time, the
reasonable period of time cannot be greater than one year, consistent with the statutory
text. See Section IV.D of the final rule preamble and the Agency's Response to Comments
Section 4. These and other provisions in the final rule should ensure federally licensed or
permitted projects are able to proceed as Congress envisioned - that is, proceed in a timely

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manner consistent with the water quality protection goals central to the CWA and section
401.

The Agency strongly disagrees with commenter assertions that Congress intended for
Federal agencies to have the primary authority for decisionmaking under section 401. On
the contrary, the legislative history regarding section 401 and its predecessor, section 21(b)
of the 1970 Water Quality Improvement Act, reveal Congress' clear intent to ensure states
had the authority to protect their waters and ensure federally licensed or permitted projects
would not "in fact become a source of pollution" either through "inadequate planning or
otherwise." 115 Cong. Rec. 9011, 9030 (April 15,1969). See Section III of the final rule
preamble for further discussion on the history and development of Section 401. Consistent
with the overall cooperative federalism framework of the CWA, section 401 authorizes
states and authorized Tribes to play a significant role in the Federal licensing or permitting
process. Accordingly, as discussed throughout the final rule preamble, this final rule reflects
these same cooperative federalism principles.

16.3 General Input on Infrastructure, Industry, Etc.

A couple of commenters more generally requested that in making changes to the 2020 Rule, EPA should
consider the impacts to infrastructure projects (e.g., timing, scope of certification), without explicitly
voicing support or opposition to previous regulatory regimes in these particular statements. Similarly, a
few commenters who supported the 2020 Rule asserted that the Agency should consider impacts on
industry and/or infrastructure in final rule development. One commenter asserted that EPA should
consider the proposed rule's effects on all types of infrastructure, while another specifically called on
EPA to ensure the final rule enables clean energy infrastructure. A different commenter raised concerns
with project delays in terms of costs, time, and legal challenges, citing that permitting and National
Environmental Policy Act assessments typically take more than a decade for new mines and mine
expansions. This commenter argued that EPA should recognize the importance of, and assess the
permitting impacts on, mining projects in an effort to advance a green economy, infrastructure, and rural
development.

Conversely, in the context of the 2020 Rule, several commenters raised particular concerns about
economic and/or political interests taking precedence over environmental and/or public health concerns
with regard to these types of projects. A few commenters called for balance of development with
environmental protections and/or between states, Tribes, and the Federal government.

A number of commenters discussed impacts related to infrastructure and/or specific types of
infrastructure in their comments when voicing general opposition to the proposed rule (and/or support for
the 2020 Rule). Most of these commenters referenced the energy sectors (exploration, generation, and/or
transportation, including specific mention of pipelines by several). A few commenters referenced the
hydropower sector, providing examples of projects that were delayed prior to the issuance of the 2020
Rule and asserting that the 2020 Rule appropriately corrected issues related to timing and scope of
certification and conditions. A couple commenters specifically asserted that the 2020 Rule would ensure
expeditious licensing of clean energy projects that would meet the Administration's goals. Another

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commenter argued the mining sector is one of the most regulated by the Federal government and states,
and discussed apparent misuse and resulting inefficiency, delay, modification, and blocking of projects
under Section 401.

Several of the commenters who discussed infrastructure emphasized infrastructure of purported national
importance, and several commenters emphasized infrastructure of purported international impact. A few
commenters asserted that the proposed rule was inconsistent with the Administration's energy
infrastructure priorities and/or climate change goals and would slow or delay energy development during
global and domestic energy challenges (referencing the war in Ukraine) and delay nationally important
projects. Several commenters highlighted the role of their industries (e.g., clean energy, natural gas,
nuclear energy) towards clean energy and decarbonization goals. One commenter called on EPA to
consider regulations' impact on national security policy.

More than half of the commenters who made general comments discussed specific industry sectors,
including infrastructure, such as the following: agriculture, clean energy (e.g., decarbonization efforts,
renewables, solar, electrical transmission and interconnection), energy, including from fossil fuels (e.g.,
gas, natural gas, oil, pipelines), nuclear energy, mines (e.g., coal, hardrock), and transportation (e.g.,
roads, bridges, airports). These commenters tended to connect their comments on the proposed rule to
impacts on their particular sector(s) (e.g., delays, financial impacts), with some connecting those
arguments to broader interests, such as economic development, interstate commerce, infrastructure
upgrades, national security, climate change mitigation and clean energy, environmental protection, and
equity.

Some commenters discussed concerns with infrastructure and/or specific industry project delays under the
proposed rule, focusing on the time it takes to plan and develop various projects and the importance of
timely certifications for infrastructure and energy projects. A number of commenters argued that timing
issues (e.g., delays) can cause substantial impacts (e.g., timing, financial) to these projects that some
argued jeopardize their completion. Several commenters expressed concern that the proposed rule would
lead to ambiguities that would prevent or delay projects. In very similar language, a couple of
commenters raised concerns about lengthy permitting processes and resulting timing and financial
impacts for mining projects in the U.S., including compared to other countries, in the context of Section
401. These commenters argued that these permitting requirements do not provide substantial
environmental benefits and put the U.S. at a competitive disadvantage, impacting communities that would
benefit from the projects for jobs, tax revenues, and other socioeconomic factors. A couple of commenters
asserted that the proposed rule would create inconsistencies that would lead to reduced investments in the
context of energy related projects. One of these commenters claimed that the proposed rule would lead to
permitting delays and would eliminate the well-defined timeline review process that Congress intended.
They asserted that a well-defined timeline review process was critical for the development of reliable and
affordable energy infrastructure which all Americans depend on.

One commenter cited a July 27, 2022, press release about the Inflation Reduction Act and anticipated
permitting reform, urging EPA to wait to implement any changes to Section 401 regulations until after
those changes.

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Conversely, one commenter argued that the proposed rule would help streamline the process for
infrastructure improvements. Another commenter asserted that more stringent regulation and consistency
is needed to hold the construction industry liable for its negative impacts. The commenter observed that
issuance of construction permits involves limited analysis on the impact proposed buildings will have on
water quality even though the buildings have the potential to impact many who rely on the waters they are
built in.

Agency's Response: The Agency appreciates commenter input on infrastructure and
development. The Agency recognizes that a variety of federally licensed or permitted
projects, including infrastructure related projects and projects in other industries, may be
subject to the certification process. As discussed in the final rule preamble, the final rule
supports a more efficient, effective, and predictable certifying authority-driven certification
process consistent with the water quality protection and other policy goals of CWA section
401 and Executive Order 13990. Although the final rule may impose some burdens on
certifying authorities (e.g., reasonable period of time negotiations) and project proponents
(e.g., pre-filing meeting requests), the Agency expects that clear, unambiguous procedural
requirements will improve section 401 procedural efficiencies for both certifying authorities
and project proponents. The final rule clarifies ambiguities in the section 401 process,
including scope, modifications, neighboring jurisdictions assessments, and procedures, that
would apply when EPA acts as the certifying authority. These revisions will help
standardize the certification process, reduce confusion, and promote efficient section 401
reviews. See the Final Rule Economic Analysis for a qualitative discussion on the potential
impacts of the final rule; see also the Agency's Response to Comments in Section 16.2.2
regarding commenter concerns over project delays.

The Agency strongly disagrees with commenter assertions that the certification process does
not provide substantial environmental benefits. On the contrary, section 401 allows states,
territories, and tribes to ensure that federally licensed or permitted activities will comply
with their applicable water quality requirements. See Section 4 of the Final Rule Economic
Analysis for further discussion on the incremental benefits anticipated from the final rule,
including incremental water quality improvements resulting from efforts to standardize
information included in requests for certification and changes in scope of certification
relative to the 2020 Rule.

The Agency also strongly disagrees with the commenter who asserted that the proposed rule
would eliminate the well-defined timeline review process that Congress intended. On the
contrary, this final rule is consistent with the plain language of section 401, which provides
that the reasonable period of time shall not exceed one year from the date the request for
certification is received.

In response to the commenter who requested that the Agency delay any section 401
rulemaking efforts until permitting reform occurs, the Agency notes that the commenter
appears to refer to permitting reform related to the Inflation Reduction Act, which has
already been enacted and did not address section 401 certification. More broadly, the

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Agency declines to delay rulemaking regarding section 401 until there no longer any
possibility of Congressional action on the matter. EPA found, and continues to find, it
appropriate to revise the 2020 Rule for several reasons. First, the 2020 Rule does not
represent the best statutory interpretation of fundamental concepts, such as the scope of
certification. See section IV.E of the final rule preamble for further discussion on why the
2020 Rule's interpretation of the scope of certification is inconsistent with the statutory text
of section 401 and authoritative Supreme Court precedent interpreting that text. Further,
the 2020 Rule did not align with the broader water quality protection goals of the Act or
Congressional intent behind development and passage of section 401. The 2020 Rule also
failed to appropriately address adverse impacts to state and Tribal water quality, as
evidenced in public comment.18 See e.g., section IV.E of the final rule preamble for further
discussion on the potential adverse water quality-related impacts of the 2020 Rule's
interpretation of the scope of certification. Accordingly, it is appropriate for the Agency to
promulgate this final rule to ensure effective implementation of Section 401. If in the future
Congress revises section 401, EPA would revise its regulations implementing CWA as
appropriate.

16.4 General input on Biden Administration priorities

16.4.1 Biden Administration Goals

Several commenters discussed the Biden Administration's priorities in their comments, voicing general
support for the proposed rule and/or critiquing the 2020 Rule. Nearly all of those commenters argued that
the proposed rule is consistent with and/or would advance the principles of Executive Order 13990. One
of these commenters argued that revising and replacing the existing Section 401 regulations would
advance EPA's priorities around access to clean air and water and climate change resilience. One
commenter called for a rule that was consistent with the CWA and the Biden administration's goals
around environmental protection, while also providing regulatory certainty and efficiency in certifications
for clean energy projects.

Many of the commenters who discussed industry sectors, including infrastructure, framed their comments
around the Biden Administration goal(s). Most of these commenters presented their sector(s)' (e.g.,
natural gas, nuclear energy, mining) role in supporting such goals, such as around decarbonized (i.e.,
"clean") energy, infrastructure, supply chains, manufacturing, and/or economic growth and argued that
issues with the Section 401 process (e.g., delays, misuse) could hinder achievement of these goals.

One of these commenters mentioned the importance of mining for the Bipartisan Infrastructure Law's
(BIL) implementation. This commenter argued that delays and expanded permitting issues will make
implementation of the Bipartisan Infrastructure Law - as well as goals to advance clean energy, reduce

18 For example, commenters noted that use of the 2020 Rule's procedural requirements on certifications
for the Corps' Nationwide General Permits resulted in certifications with conditions or denials being
treated as constructive waivers. As discussed in section IV.F in this preamble, the Agency recognizes that
a constructive waiver is a severe consequence; a waiver means that a Federal license or permit that could
adversely impact the certifying authority's water quality (i.e.. cause noncompliance with water quality
requirements) may proceed without any input from the certifying authority.

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reliance on adversarial countries (e.g., China) for critical minerals, and strengthen supply chains for
critical minerals - unachievable.

Agency's Response: The Agency agrees that the proposed rule, and this final rule, support a
certification process consistent with the principles of Executive Order 13990. See Sections II
and IV of the final rule preamble for further discussion on Executive Order 13990,
including how the final rule provides greater clarity and acknowledgment of essential water
quality protection concepts from Executive Order 13990.

In response to comments regarding Administration goals and industry, the Agency
disagrees that the final rule will hinder achievement of Administration goals, including
implementation of the Bipartisan Infrastructure Law. Rather, the final rule supports a
more efficient, effective, and predictable certifying authority-driven certification process
consistent with the water quality protection and other policy goals of CWA section 401 and
Executive Order 13990. See the Agency's Response to Comments in Section 16.4.1 for
further discussion on how the final rule supports an efficient certification process.

16.4.2 Equity and Environmental Justice Issues

A couple of commenters called for EPA to consider environmental justice in revising the 2020 Rule. A
few commenters discussed environmental justice implications from the 2020 Rule. One commenter
highlighted the importance of meaningful participation in this context and argued that the proposed rule is
an improvement over the 2020 Rule in that regard. Another commenter expressed support for the
proposed rule, arguing that the 2020 Rule striped state, Tribal, and local authority and participation, and
that such agency decision-making is critical for environmental justice. One commenter raised concerns
about the U.S. 278 Corridor Improvements project in South Carolina and argued that the 2020 Rule
limited the ability to consider environmental justice concerns. After calling for restoration of state and
Tribal authority and autonomy, another commenter argued that removal of that authority imposed risk on
a population without compensation, which the commenter characterized as a sacrifice for short-term
corporate profits and an injustice. This commenter specifically mentioned the extraction, transportation,
and use of fossil fuels in this context.

Several other commenters mentioned environmental justice considerations outside the context of Biden
Administration priorities. After discussing Tribal authority, another commenter argued that the proposed
rule reflected the Federal government's commitment to environmental justice. The commenter also
suggested that EPA take seriously and continue to advance its environmental justice obligations,
particularly in terms of meaningful public participation. One commenter argued that by supporting Tribal
authority, the proposed rule would support implementation of the Biden Administration's priorities
around Tribal authority and environmental justice, especially if implemented with EPA's proposal to draft
a rule on Tribal off-reservation water resources. Another commenter framed their comments in support of
state and Tribal authority in terms of environmental justice, providing an example from a New York
pipeline, and mentioned that restoring state and Tribal authority was critical to meeting the Biden
Administration's environmental justice goals.

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Another commenter characterized the proposed rule as a beneficial first step towards quality-of-life
improvement and identified existing disproportionate effects on low-income populations and
communities of color, citing large populations - especially Native American populations - without access
to clean water and plumbing, along with economic, pollution, and health disparities. In their support of
the proposed rule, one commenter argued that water pollution burdens those who are least able to afford
or find alternatives, a situation they characterized as an environmental justice issue.

Among commenters who discussed industry sectors, including infrastructure, a couple discussed equity or
justice issues, arguing that an efficient certification process was key for advancing these ideals (along
with climate change efforts). One of these commenters provided a detailed discussion of the role of
nuclear energy in these efforts, including "in a socially and environmentally just transition to a
decarbonized electrical grid" and "climate justice."

Another commenter argued that reviewing and revising the CWA may be necessary to improve clean
water in areas without access to clean drinking water, which they attributed to corruption and lax laws,
and called for accommodating underprivileged areas. One commenter voiced concern about CWA
loopholes and gaps and provided detailed examples from California, some of which pertained to
environmental justice.

Agency's Response: The Agency appreciates commenter input on environmental justice and
section 401. The Agency recognizes that the burdens of environmental pollution
disproportionately fall on certain communities with environmental justice concerns, and
EPA is responsive to environmental justice concerns through multiple provisions in this
rule. See Section VI.J of the final rule preamble for further discussion on how the final rule
considers environmental justice and Section 5 of the Final Rule Economic Analysis for
further discussion on how the Agency qualitatively assessed whether the change in benefits
from the rulemaking may be differentially distributed among communities with
environmental justice concerns.

Regarding comments more generally addressing environmental justice and the CWA, the
Agency notes that these comments are outside the scope of this rulemaking, but appreciates
commenter input.

16.5 General - Other Topics

16.5.1 Other Federal Licenses/Permits and Statutory and Regulatory Provisions

A few commenters discussed other Federal permits and regulations. One of these commenters
recommended that EPA coordinate and accommodate timelines of other Federal permits for ease of
review but did not mention specific industry sector(s) in that statement. Another commenter argued that
the proposed rule added or maintained procedures that are not aligned with some Federal agencies'
existing procedures.

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A few of the commenters who discussed specific sectors discussed roles of Federal agencies other than
EPA. One of these commenters mentioned FERC and the Corps in their discussion of Federal and state
roles in the Section 401 process and called on EPA to consider the interactions between Section 401
certifications and FERC policies. Another one of these commenters also called for not delaying Federal
application processes. This commenter also cited the intergovernmental Organisation for Economic Co-
operation Development (OECD) Nuclear Energy Agency (NEA) in highlighting the need for efficiency in
licensing to meet U.S. goals.

One commenter asserted that certification decisions that address issues beyond the specific requirements
in section 401 undercut the scope of exclusive authority that Congress delegated to other Federal
agencies, like FERC under the Federal Power Act, and argued that the broader the scope of section 401,
the more limited a Federal agency's exclusive authority. The commenter noted that the Federal Power Act
does not require FERC to adopt recommendations of state agencies if they are not in the national public
interest, but states often make these recommendations conditions in their section 401 certifications since
FERC must include them in a license. As a result, the commenter asserted that section 401 can become a
mechanism to undermine Congress's express directive in the Federal Power Act that FERC has exclusive
authority to balance competing interests, citing a FERC report that provided that certification do not take
into account the benefits of hydropower or other competing interests.

One commenter noted that section 401 is one of the exceptions to FERC's exclusive jurisdiction under the
Federal Power Act and has been critical to restoring water quality and designated beneficial uses on rivers
where FERC issued original project licenses prior to the enactment of the CWA. The commenter further
noted that some of these original licenses permitted diversion and dewatering of entire river sections and
destroyed aquatic habitat and recreational opportunities. The commenter also argued that the Nation's
water quality goals cannot be achieved if Federal licenses can be used as a shield against compliance with
applicable water quality requirements.

One commenter asserted that EPA permit requests for offshore wind must fully account for cumulative
displacement of fisheries over time and space and set criteria that protects and preserves nearby fish
dependent communities from harm. The commenter also asserted that section 401 should extend into a
state's offshore waters to the exclusive economic zone (EEZ), whether coastal zone management certified
or not, if the pollutant, i.e., offshore wind, affects access to fisheries resources in the EEZ for adjacent or
nearby communities that rely on access to ocean waters for their vitality and socioeconomic stability. The
commenter also argued that EPA has a responsibility to protect communities and ensure that offshore
wind development is not in fishing grounds that cause displacement of community natural resource fish
assets necessary to sustain the coastal communities, including ensuring dungeness crab fatalities are not
the result of EPA issuing offshore industrial permits. The commenter also suggested that EPA should
require socioeconomic impact analysis that avoids loss of coastal income as a regulatory requirement
when it updates the PR&Gs associated with section 401 certifications.

One commenter stated it supported continued exemption from NPDES permits for commercial fishing
vessels under 79 feet in length whose discharge does not have a significant effect on overall ocean water
quality or people's health.

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Agency's Response: Section 401 certification is required for any Federal license or permit to
conduct any activity that may result in any discharge into "waters of the United States." 33
U.S.C. 1341(a)(1). EPA recognizes that there is an array of licenses and permits that may
trigger the need to seek certification. The Agency made several changes from the proposed
rule, in part in response to commenter concerns over impacts to the Federal licensing or
permitting process (i.e., contents of a request for certification). As discussed throughout the
final rule preamble and this Response to Comments document, the final rule clarifies
certain aspects of section 401 implementation that have evolved in response to over 50 years
of judicial interpretation and certifying authority practice, and it supports an efficient and
predictable water quality certification process that is consistent with the cooperative
federalism principles central to the CWA and section 401.

In response to comments discussing the Federal Power Act, the Agency finds that questions
and comments regarding statutory interpretation of the Federal Power Act are outside the
scope of this rulemaking. As noted above, section 401 provides that any federally licensed or
permitted activity that may result in any discharge into waters of the United States are
subject to section 401; this includes FERC licenses. In response to commenters asserting
that certifications do not take factors, such as the benefit of hydropower or competing
interest, into account, the Agency notes that the scope of certification requires certifying
authorities to evaluate whether the activity will comply with applicable water quality
requirements. Accordingly, certifying authorities only need to consider factors that are
relevant to performing such evaluation.

In response to the comment regarding offshore wind projects, the Agency notes that Section
401 states that certification is required for any activity that "may result in any discharge
into the navigable waters." 33 U.S.C. 1341(a)(1). The term "navigable waters" is defined as
"waters of the United States, including the territorial seas." 33 U.S.C. 1362(7). Therefore,
federally licensed or permitted projects in the EEZ do not trigger the need to obtain section
401 certification, assuming they would not result in any discharge into navigable waters.
The Agency appreciates comments regarding coastal communities and offshore wind;
however, such comments are outside the scope of this rulemaking.

In response to the comment regarding NPDES permit exemptions, while the Agency
appreciates the comment, the comment is outside the scope of this rulemaking.

16.5.2 Protections and Environmental Outcomes

Approximately half of the commenters who wrote in general support of the proposed rule framed their
arguments around protections and/or environmental outcomes, for example in terms of ecosystems,
wildlife, water quality, drinking water, public health, public access, recreation, impacts from Federal (e.g.,
FERC) projects, impacts of the 2020 Rule, and/or economic factors. Those commenters tended to
highlight state, Tribal, and/or local roles in providing such protections. A few of the commenters who
framed their arguments around protections also characterized the proposed rule as better reflective of
science and/or fostering management based on science.

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A few other commenters voiced support for the proposed rule in terms of general protections such as
around the following issues: future generations, growth, international environmental threats, limited
availability of water resources, public health and corporate oversight, and stopping pollution and not
sacrificing water access or water quality for jobs or commerce.

One commenter asserted that recent years have shown that section 401 remains a key procedural and
informational tool for states to use in maintaining water quality in waterways and wetlands containing
fish and other aquatic species for which they possess primary management authority and argued that the
2020 Rule weakened the states' ability to utilize this tool in furtherance of sustainable fish, wildlife, and
habitat. The same commenter further asserted that restoring and clarifying key aspects of state authority
under section 401, including conditions for certification approvals, the scope of review of a project, and
Federal agency reviewability, will improve regulatory certainty and support healthy waters and habitats.

A couple of commenters discussed specific infrastructure projects that they argued had caused harm under
the 2020 Rule, such as: Brunswick Harbor Dredging, Georgia; Riverport Development, South Carolina;
U.S. 278 Corridor Improvements, South Carolina; and Conowingo Hydroelectric project, Susquehanna
River. One commenter also discussed specific impacts, such as ditching and clear-cutting resulting from
pipeline projects, and the importance of state and Tribal authority in providing protections. One
commenter pointed out that certification approvals for projects like the Conowingo project can last a long
time or be permanent, so these projects should avoid long-term adverse impacts and consider adapting to
future conditions. Another commenter highlighted the role that Section 401 had played stopping a coal
terminal in Washington and imposing additional protections for a dam in Maryland.

Several other commenters argued that their concerns around the 2020 Rule were exacerbated by climate
change considerations. In that context, some of the commenters mentioned the need for restoring the state
and Tribal authorities and protections lost in the 2020 Rule. One commenter called for local authority and
decision-making in providing protections especially because of what the commenter described as
"landscape" differences, particularly in light of climate change. Another commenter voiced support for
state and Tribal authority based on local knowledge, including of climate change impacts already being
experienced. Several commenters specifically highlighted fossil fuels and expressed a sense of urgency,
for example in encouraging EPA to implement the revised rule quickly. One of these commenters argued
that the impact of the Conowingo Dam project under the 2020 Rule would be exacerbated by climate
change impacts.

Conversely, a couple of commenters cited climate change as one of the purported improper reasons states
utilized to block energy projects under the regulatory regime prior to the 2020 Rule. One commenter
highlighted climate change as one of water quality's greatest threats and argued that the proposed rule
should not improperly burden greenhouse gas emissions reduction efforts, such as solar energy projects.

One commenter called for a well-defined process based on science and without political bias,
characterizing project proponents as "customers of water quality certifications and Federal permits."

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One commenter stated that EPA must retain authority for section 401 certifications in Federal waters with
incorporation of any Coastal Zone Management Certifications from adjoining and neighboring states. The
commenter provided the example of offshore wind facilities that require point source discharge permits
that must obtain certification for a specific number of turbines in the offshore wind farm. Specifically, the
commenter stated that the 401 water quality certification rule update must be enacted in a way that the
update will prevent the depletion of fish and fishermen.

Agency's Response: The Agency appreciates commenter input regarding the importance of
the certification process for water quality protection and the harms from the 2020 Rule. As
discussed in Section IV.E of the final rule preamble, EPA is concerned that some water
quality-related impacts identified by commenters might fall outside the scope of review
under the 2020 Rule's "discharge-only" approach to scope of review. The Agency is
finalizing revisions to the 2020 Rule to better reflect the cooperative federalism framework
and text of the 1972 and 1977 statutory amendments. The final rule also clarifies issues such
as scope of certification and the reasonable period of time for a certifying authority to act.
The final rule modifies the regulatory text implementing section 401 to support a more
efficient, effective, and predictable certifying authority-driven certification process
consistent with the water quality protection and other policy goals of CWA section 401 and
Executive Order 13990.

In response to comments regarding climate change, the Agency notes that the scope of
certification requires certifying authorities to evaluate whether the activity will comply with
applicable water quality requirements. Accordingly, certifying authorities only need to
consider factors that are relevant to performing such evaluation. EPA encourages certifying
authorities to develop certification conditions in a way that enables projects to adapt to
future water quality-related changes, i.e., so-called "adaptive management conditions." For
example, if a certifying authority is concerned about future downstream, climate change-
related impacts on aquatic species due to increased reservoir temperatures during the
lifespan of a hydropower dam license, the certifying authority might develop a condition
that would require a project proponent to take subsequent, remedial action in response to
reservoir temperature increases (e.g., conditions that might require monitoring and, as
necessary, a change in reservoir withdrawal location in the water column, a change in the
timing of releases, etc.).

The Agency disagrees with the commenter asserting that EPA has authority for section 401
certifications in all Federal waters. EPA only acts as the certifying authority on behalf of
states or Tribes that do not have "authority to give such certification." 33 U.S.C. 1341(a)(1).
See Section IV.H of the final rule preamble for further discussion when EPA acts as the
certifying authority. The Agency also notes that Section 401 does not require certifying
authorities to incorporate coastal zone management certificates in their certifications.

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16.5.3 Public notice

A few commenters wrote about public notice. After voicing support for pre-filing meetings and early
engagement and coordination between the certifying authority and project proponent, a commenter also
proposed an early public notice, where certifying authorities provide a notice of pre-filing meeting request
to affected communities. The commenter argued that early engagement can advance community
involvement and environmental justice, with communities identifying issues of potential concern.

Another commenter provided a detailed discussion of the experience with public notice in their state,
which focused on U.S. Army Corps of Engineers permitted projects. The commenter raised concerns
about the lack of a memorandum of understanding between the Corps and the two Section 401 certifying
agencies in their state and the lack of a Corps standardized approach to soliciting public comment on
certifications. The commenter added that state law only explicitly recognizes Army Corps and NPDES
permits for public notice provisions, not hydropower and interstate natural gas pipeline and liquid natural
gas terminal licenses issued by the FERC that also can trigger Section 401 requirements, which makes
public notices even less consistent and protections more difficult. The commenter suggested that the
proposed rule require Federal agencies to develop and follow standard methods for public notice and
certification procedures. While Section 401 requires state procedures, the commenter argued that states
like theirs rely on Federal agencies for providing consistent public notice. The commenter concluded this
discussion by suggesting that EPA should encourage cooperation between Federal agencies and certifying
authorities in developing public notice procedures, so that public notice is provided for all certification
applications, per Section 401.

One commenter called for EPA to prioritize the public's right to participate in water and community
protection.

One commenter argued that EPA should remove the 2020 Rule, but also consider public participation.
This commenter argued in support of the value of public input in the Section 401 process, including
sharing technical analyses and concerns.

Agency's Response: The Agency agrees that public notice can provide an important
opportunity for public awareness and engagement in the certification process. However, the
Agency disagrees with commenters asserting that Federal agencies should establish
procedures for public notice on certifications. Rather, section 401(a)(1) requires a certifying
authority to establish procedures for public notice, and a public hearing where necessary,
on a request for certification. 33 U.S.C. 1341(a)(1).

For discussion on the public notice and hearing associated with a notified neighboring
jurisdiction's objection under section 401(a)(2), please see Section IV.K of the final rule
preamble and Section 11.5 of the Agency's Response to Comments.

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16.5.4 General input on efficiency

Many commenters framed their arguments in support of the proposed rule (and/or against the 2020 Rule)
around process and administrative issues, such as in terms of the following terms (in alphabetical order):

•	Administrative burden, procedural burden,

•	Certainty,

•	Clarity,

•	Consistency

•	Durability

•	Effectiveness

•	Efficiency,

•	Flexibility,

•	Focus,

•	Predictableness,

•	Streamlined process,

•	Timeliness (e.g., decisions), and

•	Transparency.

A few commenters voiced concerns about project delays and/or inefficiencies from the proposed rule
more generally. One commenter argued that Section 401 rule changes would lead to uncertainty and
resulting timeline confusion. Another commenter argued EPA should revise the rule to avoid delays in
issuing 401 certifications, licenses, and permits. One commenter wrote that EPA should withdraw the
proposed rule, and if not, the Agency should revise the rule to make sure that unnecessary delays are
avoided for project proponents and Federal agencies. This commenter went on to argue that EPA must
remember that Congress statutorily determined the absolute maximum timeline of one year for the
Section 401 certification process.

Several commenters raised concerns about project delays because of purported misuse of Section 401
and/or inefficiencies, including in some cases under the regulatory regime prior to the 2020 Rule. One
commenter argued that prior to the 2020 Rule, states ignored or manipulated the one-year timeframe for
certification. One commenter asserted that the proposed rule would lead to lengthy certification processes
because it would return the scope, certification deadlines, and certification conditions to pre-2020 Rule
status, and argued that EPA did not adequately explain why these consequences would not occur or why
they are desirable or justified. The same commenter also asserted that prior to the 2020 Rule, the
certification process involved lengthy delays due to the regulation lacking clear deadlines, states imposing
conditions beyond the statutory scope, and the scope of certification being ill-defined and confusing,
citing the 2020 Rule's Economic Analysis in support of these assertions.

Another commenter argued that the proposed rule eliminated all accountability by the certifying authority
at the expense of the Federal permitting process and project proponent and failed to sufficiently explain
the Agency's change that removed the 2020 Rule's requirements, stating that the 2020 Rule required

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certifying authorities to act in the reasonable period of time, explain their action, and cite to a legal
authority for conditions.

One commenter raised concerns about the proposed rule leading to different requirements imposed by
more than 50 certifying authorities, in the commenter's characterization. Another commenter asserted that
the CWA authorizes EPA to create uniform regulations, citing Arkansas v. Oklahoma, 503 U.S. 91, 110
(1992), and that EPA had previously recognized that uniformity was critical, citing the proposal to the
2020 Rule.

One commenter wrote in support of EPA's efforts around improved predictability and timeliness by
removing the 2020 Rule's apparent ambiguities, but argued the proposed rule was in opposition with
these goals and might run contrary to Section 401's intent, as the proposed rule still included ambiguity
that could affect projects' timing in terms of permitting and implementation, causing confusion for project
proponents. Another commenter argued that the proposed rule would improve efficiency, but voiced
concern that the proposed rule left some "inefficiencies" unaddressed.

Agency's Response: The Agency appreciates commenter concerns regarding delays or
inefficiencies. As discussed in the final rule preamble, the final rule supports a more
efficient, effective, and predictable certifying authority-driven certification process
consistent with the water quality protection and other policy goals of CWA section 401 and
Executive Order 13990. See the Agency's Response to Comments in Section 16.2 and 16.3
for further response to comments on delays and/or inefficiencies from the final rule. The
final rule also addresses stakeholder concerns regarding the pre-2020 Rule landscape, e.g.,
by clarifying important concepts such as how certifying authorities are limited to
considering adverse impacts to water quality.

The Agency disagrees with commenter assertions that the proposed rule would remove all
accountability by the certifying authority, and that it would lead to a lengthy process. On
the contrary, this final rule enshrines the cooperative federalism principles central to
section 401 while respecting the substantive and procedural guardrails Congress intended.
For example, several aspects of this final rule provide certifying authorities with the ability
to inform the certification process, e.g., pre-filing meeting requests, contents of a request for
certification, reasonable period of time, while at the same time recognizing the need for
predictable and transparent backstops. See the final rule preamble and the Agency's
Response to Comments document for further discussion on the Agency's rationale for these
and other final rule provisions. The Agency also disagrees with commenter assertions that
the Agency failed to sufficiently explain the removal of the 2020 Rule's requirements for the
contents of a certification decision. See Section IV.F of the final rule preamble for
discussion of the Agency's rationale for removing the required contents in certification
decisions. See also the Agency's Response to Comments in Section 6.

The Agency agrees that certainty and transparency are important and disagrees with
commenter assertions that this final rule introduces ambiguity or inefficiencies. This final
rule introduces several important process improvements (e.g., how to set the reasonable

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period of time, when extensions are permissible, what are the elements of a request for
certification, when and how to modify a grant of certification) that provide benefits to the
certification process, including regulatory certainty and transparency, efficient certification
reviews, and enhanced cooperative federalism. See the final rule preamble for further
discussion of these and other aspects of this final rule that support an efficient, clear
certification process.

In response to the commenter expressing concerns over different certifying authority
requirements, the Agency disagrees that having different certifying authority requirements
for requests for certification is inherently problematic. As an initial matter, defining an
exclusive list of components for requests for certification for all certifying authorities could
inhibit a comprehensive review under section 401 in the reasonable period of time. The
diverse nature of Federal licenses and permits and the variety of potential water quality
impacts from those different types of activities do not lend themselves to a one-size-fits-all
approach. Indeed, to define an exclusive list of contents would frustrate the intent of the
Act's emphasis on cooperative federalism and lead to procedural inefficiencies. Specifically,
a framework requiring the reasonable period of time to begin before the certifying
authority has essential information that it has transparently publicized as necessary to
make its own certification decision would be inconsistent with the language, goals, and
intent of the statute. Congress clearly did not intend section 401 reviews to turn on
incomplete applications, and the reasonable period of time and one-year backstop were
added by Congress to ensure that "sheer inactivity by the State...will not frustrate the
Federal application." H.R. Rep. No. 92-911, at 122 (1972). However, this final rule places
several guardrails on a certifying authority's ability to define additional contests in a
request for certification, including limiting the scope of additional contents to those that are
"relevant to the water quality-related impacts from the activity" and limiting the ability of a
certifying authority to request materials to those "identified prior to when the request for
certification is made." If a state or tribe fails to define such additional contents as described
above, the final rule defines additional contents for requests for certification to provide
stakeholders with greater certainty and predictability in the certification process.
Ultimately, the final rule establishes an approach that provides efficiency for requests for
certification, while staying consistent with cooperative federalism principles and case law.
See Section IV.C of the final rule for further discussion on the request for certification.

16.5.5 Other Critiques

A number of commenters made other suggestions for additional improvements in the proposed rule,
despite voicing general support for the proposed rule. One commenter suggested that the proposed rule
could be strengthened by allowing states to regulate water quality more holistically, claiming that the
proposed rule is limited to individual projects. Another commenter requested that the proposed rule be
used to protect water quality in ephemeral and isolated wetlands and that activities for certification should
include cumulative impact analysis, environmental justice, and climate change impact analysis. One
commenter voiced support for revising the 2020 Rule but argued that EPA should "go farther" in
providing protections. Another commenter called for empowering states and Tribes and for the

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"strongest" rule, which would authorize states and Tribes to review all federally-authorized activities,
including activities with only nonpoint source pollution.

Several commenters discussed perceived litigation risks associated with the proposed rule. One
commenter voiced support for the 2020 Rule and argued that the proposed rule favors "proceeding by
litigation," instead of the 2020 Rule's purported certainty. One commenter claimed that the proposed
rule's certification definitions, scope, and requirements were ambiguous, which would subject certifying
authorities to litigation, leading to issues such as diminished efficiency, predictability, and resources.
Another commenter wrote about a lack of clarity in certification requirements leading to delays, which the
commenter mentioned can lead to further delays from court challenges. A different commenter argued
that the proposed rule would be more likely to pass judicial scrutiny if it more narrowly defined state
authority. Another commenter wrote favorably about the 2020 Rule, arguing that it incorporated case law
on Section 401 and suggested that EPA withdraw or modify the proposed rule to better reflect current and
pending legal decisions. One commenter acknowledged that there will always be debate and legal
challenges over Congress' intent with regard to the CWA, and that a 2020-like rule may return. Another
commenter wrote favorably about the 2020 Rule, claiming that there was frequent litigation and resulting
issues (e.g., lack of clarity) prior to the 2020 Rule's passage, which the commenter argued sought to
address these issues. This commenter also critiqued the proposed rule for going back on the 2020 Rule's
improvements.

One commenter argued that the proposed rule was unsupported by case law, including Supreme Court
precedent.

One commenter suggested that EPA revise the current version of 40 CFR 124.53(a) to read "may
originate" to be consistent with section 401(a)(1).

Agency's Response: EPA appreciates commenters' suggestions, and the Agency made
several changes to make the final rule efficient (e.g., pre-filing meeting requests and
requests for certification provisions). The Agency disagrees that the rule is ambiguous. EPA
included multiple provisions in the final rule to increase clarity for the certification process.
For example, the final rule introduces several important process improvements (e.g., how to
set the reasonable period of time, when extensions are permissible, what are the elements of
a request for certification, when and how to modify a grant of certification) that provide
benefits to the certification process, including regulatory certainty and transparency,
efficient certification reviews, and enhanced cooperative federalism. See the final rule
preamble for further discussion of these and other aspects of this final rule that support an
efficient, clear certification process.

In response to the commenter suggesting that the rule should be used to protect water
quality in ephemeral and isolated wetlands, please see Section IV.E of the final rule
preamble and Section 5.5 of the Agency's Response to Comments for further discussion on
the scope of waters.

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In response to commenter assertions regarding the 2020 Rule, the Agency notes that the
2020 Rule does not represent the best statutory interpretation of fundamental concepts,
such as the scope of certification. See section IV.E of the final rule preamble for further
discussion on why the 2020 Rule's interpretation of the scope of certification is inconsistent
with the statutory text of section 401 and authoritative Supreme Court precedent
interpreting that text. Further, the 2020 Rule did not align with the broader water quality
protection goals of the Act or Congressional intent behind development and passage of
section 401. The 2020 Rule also failed to appropriately address adverse impacts to state and
Tribal water quality, as evidenced in public comment. See e.g., section IV.E of the final rule
preamble for further discussion on the potential adverse water quality-related impacts of
the 2020 Rule's interpretation of the scope of certification. EPA is finalizing revisions to the
2020 Rule to be fully consistent with the 1972 and 1977 CWA amendments, the Agency's
legal authority, and the principles outlined in Executive Order 13990. This final rule revises
the 2020 Rule to better reflect the CWA's statutory text, the legislative history regarding
section 401, and the broad water quality protection goals of the Act. In addition, the final
rule clarifies certain aspects of section 401 implementation that have evolved in response to
over 50 years of judicial interpretation and certifying authority practice, and it supports an
efficient and predictable water quality certification process that is consistent with the
cooperative federalism principles central to the CWA and section 401.

The Agency also strongly disagrees with commenter assertions that the proposed rule was
unsupported by case law, including Supreme Court precedent. See the final rule preamble
and this Response to Comments document generally for discussion on the relevant case law
that informed the Agency's development of this final rule.

The Agency is declining to revise section 124.53(a) to read "may originate" as suggested by
the commenter. The current text at 40 CFR 124.53(a) provides that "[u]nder CWA section
401(a)(1), EPA may not issue a permit until a certification is granted or waived in
accordance with that section by the State in which the discharge originates or will
originate." This language is consistent with section 401(a)(1), which provides that a project
proponent "shall provide the licensing or permitting agency a certification from the State in
which the discharge originates or will originate." Accordingly, the Agency does not find it
appropriate to revise the text at section 124.53(a).

16.5.6 Other Rulemakings

Several commenters submitted comments about other rulemakings, with all of them discussing the
definition of "waters of the United States." All but one of those commenters specifically discussed the
Revising the Definition of "Waters of the United States" rulemaking. One of those commenters argued
that if the "waters of the United States" rulemaking decreased the scope of protected waters, it would lead
to difficulties in protecting waters. This commenter called for a strong section 401 certification rule and
broad authority for states and Tribes.

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A couple of commenters requested explanation or clarification on how the Section 401 proposed rule
could be affected by the "waters of the United States" rulemaking, including the Sackett v. EPA case.
Another commenter called for a balanced, not too wide reaching, publicly supported, and stable definition
of "waters of the United States" and called for environmental justice and equality. This commenter
discussed the territorial seas and wrote that they assumed that the term refers to the area from 3 to 200
miles offshore, so the commenter expects that offshore wind turbines will require a National Pollutant
Discharge Elimination System (NPDES) or Section 401 permit.

A few commenters who submitted general comments in support of the proposed rule and/or critiqued the
2020 Rule discussed the definition of "waters of the United States." In similar language, most of these
commenters argued in favor of state and Tribal authority in the context of an upcoming (unnamed by the
commenters) Supreme Court case that they warned could reduce the number of waters covered by the
Clean Water Act. One other commenter called for upholding the definition and went on to discuss states'
and Tribes' role as co-regulators for providing protections through Section 401.

A few commenters mentioned the Sackett v. EPA case, discussing that a ruling for that case could affect
Section 401 certifications. One commenter appeared to allude to the Sackett v. EPA, No. 21-454 case
without explicitly naming it and requested that EPA wait on the Section 401 rulemaking to incorporate
the ruling from the case. The same commenter also doubted that Section 401 jurisdiction could apply to
waterbodies not considered "waters of the United States."

Agency's Response: Comments regarding other rulemakings, including rulemakings on
defining "waters of the United States" are outside the scope of this rulemaking. Similarly,
the Agency notes that comments regarding the Sackett Supreme Court case are outside the
scope of this rulemaking.

As discussed in Section IV.A of the final rule preamble, the final rule provides that section
401 certification is required for Federal licenses or permits that authorize any activity
which may result in any discharge from a point source into waters of the United States. 40
CFR 121.2. Therefore, any changes in the scope of waters of the United States will impact
the scope of waters in which federally licensed or permitted activities must seek section 401
certification.

16.5.7 Tribal consultation, generally

Another commenter highlighted the importance of Tribal treaty rights, including implicit rights to a
certain level of environmental quality or water quality to ensure that the explicit Tribal treaty rights are
possible. The commenter recommended that EPA codify EPA's consultation obligations (e.g., appropriate
scheduling timelines and procedures), as well as how Tribal leader's recommendations must be
incorporated into EPA's decision-making process as it related to EPA's role and authority under CWA
section 401. The commenter supported their recommendation by asserting that there has been
inconsistency in approaches to government-to-government consultation and incorporation of Tribal
recommendations, therefore consistency in Tribal consultation practices is needed to enhance the
predictability of the section 401 process for all.

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Another commenter, citing the 2010 Handbook, highlighted how section 401 provides Tribes with veto
authority over Federal licenses or permits that are subject to section 401 and do not comply with Tribal or
State water quality requirements. The commenter suggested that the certification process gives permit
applicants and Federal agencies opportunities to address Tribal concerns about their water quality, which
helps protect Tribal treaty rights and Winters rights.

Agency's Response: The Agency appreciates commenter recommendations to codify EPA's
consultation obligations. Although the Agency is declining to incorporate EPA's
consultation policy in the final rule regulatory text, the Agency notes that when EPA
certifies on behalf of Tribes without TAS, its actions as a certifying authority are informed
by its Tribal policies and the Federal trust responsibility to federally recognized Tribes.
EPA's 1984 Indian Policy, recently reaffirmed by EPA Administrator Regan, recognizes the
importance of coordinating and working with Tribes when EPA makes decisions and
manages environmental programs that affect Indian country. See EPA Policy for the
Administration of Environmental Programs on Indian Reservations (November 8,1984),
available at https://www.epa.gov/sites/default/files/2015-04/documents/indian-policy-84.pdf;
see also Memorandum from Michael S. Regan to All EPA Employees, Reaffirmation of the
U.S. Environmental Protection Agency's Indian Policy (September 30,2021), available at
https://www.epa.gov/system/files/documents/2021-09/oita-21-000-6427.pdf. This includes
coordinating and working with Tribes on whose behalf EPA reviews and acts upon requests
for certification on federally licensed or permitted projects.

The Agency agrees that section 401 authorizes states and authorized Tribes to play a
significant role in the Federal licensing or permitting process, including the ability to deny
certification for a federally licensed or permitted project that will not comply with water
quality requirements. See Section IV.E and F for further discussion on the scope of
certification and certification decisions.

16.6 Input Received in Prior Rulemakings

16.6.1 Input on the 2019 Proposed Rule

This sub-topic summarizes comments that were made on a previous proposed rulemaking and were
resubmitted by commenters in the docket for the 2022 proposed rule.

16.6.1.1 General Support v. Opposition

Some commenters voiced their opposition to the 2019 proposed rule, describing the 2019 proposed
changes as illegal and/or unlawful, unnecessary, unjustified, flawed, lacking evidence, or irrational.

Some commenters explicitly urged EPA not to weaken its guidance and regulations.

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Other commenters voiced their support for the 2019 proposed rule and encouraged EPA to finalize it.
Some of these commenters described the proposed rule as balanced, holistic, coherent, modernized,
focused, or efficient.

Agency's Response: See the Agency's Response to Comments in Sections 16.1-16.5; see also
Section III and IV of the Final Rule Preamble.

EPA reviewed the 2020 Rule in accordance with Executive Order 13990 and, in the spring
of 2021, determined that it would propose revisions to the 2020 Rule through a new
rulemaking effort. See Notice of Intention to Reconsider and Revise the Clean Water Act
Section 401 Certification Rule, 86 FR 29541 (June 2, 2021). EPA considered several factors
in making this determination, including but not limited to the text of CWA section 401;
Congressional intent and the cooperative federalism framework of CWA section 401;
concerns raised by stakeholders about the 2020 Rule, including implementation-related
feedback; the principles outlined in the Executive Order; and issues raised in litigation
challenging the 2020 Rule. Id. In particular, the Agency identified substantial concerns
about whether portions of the 2020 Rule impinged on the cooperative federalism principles
central to CWA section 401. The Agency identified this and other concerns as they related
to different provisions of the 2020 Rule, including certification requests, the reasonable
period of time, scope of certification, certification actions and Federal agency review,
enforcement, and modifications. See id. at 29543-44.

16.6.1.2 States' & Tribes' Roles Under Section 401

Some commenters argued that Congress intended for states and Tribes to have authority in protecting and
enhancing the waters within their borders, with some of the commenters pointing to 33 U.S.C. 1251(b) as
evidence of this. Some other commenters discussed the vital role that states and Tribes play under section
401 of the CWA. A few commenters emphasized that section 401 is pertinent in ensuring states' authority
in protecting water within its borders. One commenter emphasized that any revisions to EPA's guidance
or regulations must preserve the states' broad authority to protect water quality. A few commenters
argued that states have a unique understanding of waters within their jurisdiction and are therefore best
positioned to provide that input via the section 401 certification process. One commenter mentioned that
the Assistant EPA Administrator for Water, David Ross, testified in September of 2019 before the House
Committee on Transportation and Infrastructure, Subcommittee on Water, and acknowledged that states
have the best understanding of their water resources and that states can and should regulate what is
important to them in terms of their water resources.

One commenter explained that until early 2019, every EPA guidance document for state section 401
certifications issued by EPA recognized states' broad authority to condition or deny federally permitted or
licensed projects within their borders, specifically pointing to EPA's 1989 guidance. This commenter
claimed that EPA's assertion in the 2019 proposal that section 401 does not discuss the scope of states'
authority to protect the waters within their boundaries is "unfounded" and that the intent of Congress is
reflected in the plain language of the CWA. Another commenter argued that because the 2019 proposed

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rule confines states to regulate discharges when the water quality effects of federally licensed activities
may equal or exceed them, it is inconsistent with the principles of the CWA.

Many commenters argued that the 2019 proposed rule would "strip" or "curtail" states and Tribes' roles
under section 401. One commenter argued that EPA would "strip the states of their specifically prescribed
authority" and described the action as "arbitrary and capricious." Another commenter explained that
southeastern states have a "tremendous stake" in preserving their section 401 authority and that they have
relied on section 401 certifications to ensure that some of the region's largest, and potentially most
destructive projects, do not degrade state waters. One commenter contended that the 2019 proposed rule
would be detrimental to water quality and states' rights, creating more problems for project proponents
than it aims to solve. One commenter argued that the 2019 proposed rule would require states to violate
their own statute and regulations (or change their own administrative processes) which goes beyond
EPA's authority to implement section 401.

A few commenters argued that states have been responsibly exercising their authority under section 401
for decades. One commenter added that states efficiently and effectively review thousands of water
quality certifications each year. Another commenter emphasized that the certification process in place has
shown that states have exercised their authority "efficiently and responsibly." A few commenters argued
that contrary to what then Administrator Wheeler said, states have not been exceeding their authority or
abusing the section 401 process. One of the commenters further stated that EPA twisted facts to fit into
the Trump administration's "false narrative" about section 401. Another commenter mentioned that EPA
did not identify any specific examples of a state abusing its power.

A few commenters argued that EPA cannot interpret "appropriate requirement of state law" in a way that
conflicts with PUD No. 1. These commenters added that EPA's position in the 2019 proposed rule that a
state may only impose water quality limitations specifically tied to a discharge contradicts section 401.
One of the commenters further elaborated that because PUD No. 1 interpreted the unambiguous terms of
section 401 to allow states to impose conditions on a permitted activity as a whole, EPA's 2019 proposal
to limit state conditions to specific discharges is an "unconstitutional administrative revision of a
Supreme Court holding."

Some commenters discussed the importance of cooperative federalism. A few commenters emphasized
that cooperative federalism is best served by clear and harmonious Federal and state roles. Another
commenter contended that expanded Federal authority disregards cooperative federalism. One commenter
emphasized that the cooperative federalism system Congress established in section 401 makes it clear that
"decisions related to the scope of state agency review are vested in state agencies as long as they are at
least as stringent as the Clean Water Act, not EPA or other federal agencies." The commenter added that
it is the statutorily mandated authority that allows a state to deny an application for section 401 under the
cooperative federalism system. One commenter argued that the 2019 Guidance undermines cooperative
federalism by attempting to limit state review of application for section 401 certifications.

A few commenters who were generally supportive of the 2019 proposed rule expressed that it presented a
good balance. One commenter stated that the 2019 proposed rule balances the states' interest in water
quality while insuring access to markets for all states' important products and services. Another

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commenter voiced their appreciation for EPA's efforts and expressed that the 2019 proposed rule struck
an appropriate balance between "regulatory efficiency and environmental stewardship."

Agency's Response: See the Agency's Response to Comments in Section 5, Sections 16.6.1.1.

16.6.1.3	Consistency with Clean Water Act & Legislative History and Statutory Text

Many commenters argued that the 2019 proposed rule is inconsistent with the language in the CWA
and/or legislative history. Some commenters emphasized that the main goal of the CWA is to "restore and
maintain the chemical, physical, and biological integrity" of the waters of the United States and any rule
must strive to achieve this objective. One commenter emphasized that any changes to EPA's guidance or
regulations must be consistent with the CWA and intent of section 401. One commenter contended that
the 2019 Guidance directly contradicts both the language and intent of the statute as well as applicable
case law and the CWA. The commenter urged EPA to refrain from incorporating the "improper positions"
in the Guidance into EPA's future revisions to section 401 implementing regulations.

One commenter argued that the 1971 Rule are already consistent with the CWA and should not be
changed. This commenter stated that legislative history supports EPA's decades-old interpretation of
section 401 and contended that the 1971 Rule and the 2010 guidance better reflect the statutory text than
the 2019 proposed rule.

Other commenters posited that the 2019 proposed rule was consistent with the CWA. One of the
commenters contended that the 2019 proposed rule offers the first holistic, coherent reconciliation of the
statute, taking into consideration the context and structure of section 401 and the focus and purposes of
the CWA.

Agency's Response: See the Agency's Response to Comments in Sections 16.6.1.1.

16.6.1.4	2019 Proposed Rule Process

A couple of commenters shared their opinion on specific language used within the 2019 proposed rule.
One of the commenters recommended that the final rule and any associated guidance maintain language
consistent with the current section 401 text. The commenter added that EPA should continue to use the
term "applicant" instead of "project proponent" or at least provide a reasoning behind the change.

Another commenter argued that EPA's 2019 proposed rule interpretation that the term "applicant" is
limited by, and effectively interchangeable with, the term "discharge" falls outside the scope of ambiguity
in the statute and is therefore unreasonable.

A few commenters discussed the 2019 proposed rule's timing, with one commenter arguing that the 2019
proposed rule will "improperly hinder" review by certifying authorities. The commenter suggested that
the time on reviews should begin running once the certifying authority concludes that it has received a
complete request. Another commenter argued that the 2019 proposed rule's timing provisions are
restrictive and could lead to the waiver of state certification, which could lessen protection of species and
their habitats. One commenter stated that the 2019 proposed rule mandates a certification process that will

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frustrate the ability of certifying authorities to regulate water quality. One commenter expressed concern
that the 2019 proposed rule would result in increased certification denials, delays, and confusion. One
commenter added that the 2019 proposed rule must not limit the one-year review period prescribed by
Congress and allow states to follow their own administrative processes. This commenter stated that the
2019 Guidance improperly attempts to restrict the timing for state review of water quality certification
applications under section 401, to limit the information states can require to evaluate such applications,
and to impose Federal oversight of state decisions on certification applications.

A few commenters discussed the 2019 proposed rule with respect to how it will prevent states from
imposing conditions. One commenter emphasized that the power of states to reject 401 applications, or to
place strong protective conditions on projects as part of approving a 401 certification have been
instrumental in carrying out the goals of the CWA. One commenter voiced concern that if the 2019
proposed rule is made final, states would be prevented from imposing conditions on section 401
certifications that protect endangered species and their habitats from a variety of impacts. One commenter
suggested that EPA should not require that a certifying authority explain why a condition is necessary.

One commenter provided a specific suggestion and stated that when EPA is acting as the certifying
authority, the "public notice" requirement should be expanded to include the general public.

Other commenters claimed the 2019 proposed rule would bring regulatory certainty and clarity. One
commenter argued that the 2019 proposed rule would reduce the potential for conflicting interpretations
of the certifying authority's role. The commenter also added that the 2019 proposed rule clarifies the
ambiguity with respect to the scope of section 401, specifically the certifying authority's review,
determination, and condition-setting. Another commenter suggested that the 2019 proposed rule properly
defined the period for review, the proper scope of the CWA, and the conditions were appropriately
included. The commenter added that this will effectively curtail abuses of section 401 and reduce
ambiguity. One commenter emphasized the importance of regulatory certainty, including a process that is
reasonable, predictable, and cost effective. Another commenter applauded the clarity of the timing and
scope of section 401 certifications in the 2019 proposed rule, as well as the information requirements
certifying states may impose.

Agency's Response: See the Agency's Response to Comments in Sections 3,4, 5, 6,16.6.1.1.

16.6.1.5 Infrastructure/Development

One commenter voiced their opinion about the importance of balancing states' rights with the necessity
that states be allowed to move products in interstate commerce, and added that under the 1971 Rule, too
many states were using it to "frustrate and impede" interstate commerce. Another commenter argued that
states have used section 401 to delay or halt projects, such as natural gas pipeline, energy, and mining
projects. The commenter argued the implementation of section 401 has been inconsistent, which
"frustrates" the CWA's Federal-state balance, and has resulted in delays to interstate natural gas pipeline
projects. One commenter contended that the previous clarity and direction on section 401 certification
process led to significant delays in Federal permitting of projects, such as major mining projects. One

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commenter argued that pipeline construction permits have been delayed or denied in New York, Oregon,
and other states for reasons that "stretch the intent of the Clean Water Act beyond protecting water."

Agency's Response: See the Agency's Response to Comments in Sections 16.6.1.1.

16.6.1.6 Analysis/Justification

Some commenters mentioned that the 2019 proposed rule was not justified. A couple of commenters
contended that the post-1971 amendments to section 401 do not justify the changes in the 2019 proposed
rule or a full regulatory overhaul. Some commenters argued that there was a lack of evidence that the
1971 Rule and procedures were inadequate. One of the commenters contended that EPA failed to provide
a "reasoned explanation" for "upending 47 years of precedent" in the 2019 proposed rule in a manner
which ignores the statute's plain purpose and meaning. The commenter added that promoting energy
infrastructure development is not a reasoned explanation and it falls outside the scope of the statute as
EPA "relied on factors which Congress has not intended it to consider."

A couple of commenters did not agree with EPA's statement that the 2019 proposed rule is the Agency's
first, holistic reading of the CWA. One commenter argued that EPA offered a weak attempt to justify the
2019 proposed rule based on the argument that EPA has never taken a "holistic" approach to interpreting
the statute and that it contradicts the Supreme Court and every Federal court to consider important
questions regarding the implementation of section 401. The commenter further stated that EPA has
already spoken twice on the application of section 401 in the broader context of the CWA - in the 1989
memo and 2010 Handbook.

Another commenter argued that EPA's interpretation differs dramatically from that of numerous U.S.
Supreme Court rulings, such as PUD No. 1 and S.D. Warren.

A couple of commenters argued that necessary analyses were not done prior to the publication of the 2019
proposed rule. One of the commenters emphasized that they were unaware of any thorough analysis that
the 2019 proposed changes would (1) achieve E.O. 13868's objectives or (2) protect the nation's water
resources according to the objective of the CWA. Another commenter contended that the 2019 proposed
rule fails to comply with the National Environmental Policy Act (NEPA). A couple of commenters argued
that EPA disregarded the consultation requirement of the Endangered Species Act (ESA) in the 2019
proposed rule. One of the commenters further stated that any agency action that may affect a listed
species or its critical habitat triggers the consultation requirement. Another commenter explicitly stated
that they rejected any regulatory changes related to environmental permitting without comprehensive and
effective consultation between states and the Federal government. Several commenters voiced their
concern that EPA did not consult with states, Tribes, or agencies prior to the publication of the 2019
proposed rule.

Agency's Response: See the Agency's Response to Comments in Sections 16.6.1.1.

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16.6.2 Pre-proposal Input from 2021

This sub-topic summarizes input that was received prior to the 2022 proposed rule and was resubmitted
by commenters in the docket for the 2022 proposed rule.

16.6.2.1	General Support v. Opposition

Many stakeholders supported EPA's decision to reconsider and revise the 2020 Rule and urged EPA to
promptly repeal it. Some of these stakeholders described the 2020 rule as unlawful, illegal, harmful,
politically driven, flawed, ill-conceived, arbitrary and capricious, and/or "an affront to the cooperative
federalism at the heart of the Clean Water Act." One stakeholder pointed to several court challenges of
the 2020 Rule to demonstrate "just how badly EPA erred when it issued this Rule." The stakeholder
explained that these pending court cases sought restoration of certifying authorities' power under the
CWA and relief from the harm the rule was causing. This stakeholder also argued that EPA has no choice
but to repeal most or all of the 2020 Rule due to pending lawsuits and basic statutory interpretation.

A few stakeholders were in opposition to EPA revising or repealing the 2020 Rule. One stakeholder
described the 2020 Rule as effective and consistent.

Agency's Response: See the Agency's Response to Comments in Sections 16.6.1.1.

The Agency has discussed its rationale for regulatory revisions to the 2020 Rule and, where
appropriate and relevant, how the final rule compares to the 1971 Rule and pre-2020 Rule
practice throughout the final rule preamble, in this Response to Comments document, and
in the Final Rule Economic Analysis.

16.6.2.2	States' & Tribes' Roles Under Section 401

Several stakeholders discussed why section 401 is a foundational part of the CWA and emphasized its
importance to states and Tribes, particularly related to their role in protecting their waters. A few
stakeholders emphasized that they rely on section 401 to protect their waters.

Stakeholders argued that the 2020 Rule "stripped" or "curtailed" states' and Tribes' authority under
section 401. Several stakeholders claimed that the 2020 Rule undermined the ability of states and Tribes
to protect their waters. Some stakeholders further argued that this led the 2020 Rule to negatively impact
water quality. One stakeholder argued that the 2020 Rule threatened long-standing state water quality
protections and undid decades of progress in protecting and preserving state water quality.

Multiple stakeholders urged EPA to restore section 401 authority to states and Tribes, including one
commenter who asserted that it must be restored to meet the CWA's objectives. One stakeholder
emphasized the importance of state and Tribal expertise in reviewing projects. Another stakeholder
emphasized that states have responsibly exercised their authority under section 401 and under state water
quality statutes to protect water quality, while another commenter asserted that the 2020 Rule favored a
few projects inconvenienced by complying with the law. One stakeholder stated that any new rule should

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allow flexibility to accommodate certifying authority procedures that govern the processing of water
quality certification requests.

Agency's Response: See the Agency's Response to Comments in Sections 16.6.1.1,16.6.2.1.

16.6.2.3	Consistency with Clean Water Act Statutory Text Supreme Court Precedent/Court

Cases

Some stakeholders claimed that the 2020 Rule was inconsistent with the plain language of the CWA, the
objectives of the Act, and contrary to Supreme Court precedent. One commenter contended that the 2020
Rule was a Federal power grab and urged EPA to correct the previous administration's attempt to subvert
the plain intent of Congress.

Conversely, one stakeholder argued that the 2020 Rule aligned with the statutory text of section 401, and
reduced the potential for conflicting interpretations of the certifying authority's role in the implementation
of section 401.

Agency's Response: See the Agency's Response to Comments in Sections 16.6.1.1,16.6.2.1.

16.6.2.4	Impacts of the 2020 Rule and Pre-2020 Rule on Efficiency

Some stakeholders discussed delays and/or denials that they experienced prior to the 2020 Rule. One
stakeholder claimed that important infrastructure projects were being delayed or cancelled due to the
section 401 regulations being outdated. Another stakeholder contended that lengthy and costly delays
were often caused by lack of clarity in how proponents and agencies should address specific authorization
requirements, which leads to additional delays where project-specific interpretations are challenged in
Federal and state courts. The stakeholder urged EPA to carefully consider the regulatory context as they
evaluate whether to revise the 2020 Rule.

Alternatively, other stakeholders argued that there were very few delays or denials prior to the 2020 Rule.
A few stakeholders asserted that when delays occur, they are often due to the applicant (e.g., incomplete
information) and that denials are rare. One of these stakeholders contended that reverting to the previous
section 401 regulations in place would reduce denials or delays, while another one of these stakeholders
noted that denials increased when the 2020 Rule was promulgated. Another stakeholder contended that
pre-2020 Rule, for the vast majority of applications and projects, the section 401 certification process was
not controversial, and most requests were granted by states within a reasonable timeframe.

A couple of stakeholders argued that more delays will occur if the 2020 Rule is retained. For example,
one stakeholder claimed that if the 2020 Rule is retained, the rule itself and projects certified under the
rule will face litigation, which will create additional delay and uncertainty. Another stakeholder claimed
that the 2020 Rule likely slowed down the certification process because it allowed applicants to submit
just basic information to "start the clock" for the state or Tribe's decision. The stakeholder explained that
receiving insufficient information to ensure a project will comply with their laws, certifying authorities

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may just decide to deny certification entirely, which may trigger additional litigation or reapplication.
Another stakeholder argued that the limitations on the timing of state review resulted in inadvertent
waivers of section 401 authority for major Federal permits. The stakeholder contended that the 2020 Rule
created administrative confusion and unnecessary regulatory burdens for applicants and administrative
agencies.

On the other hand, one stakeholder voiced their support for the 2020 Rule because the commenter
contended it helped define the specific procedures, timeframes, and scope for section 401 certifications.

Agency's Response: See the Agency's Response to Comments in Sections 16.6.1.1,16.6.2.1.

16.6.2.5	Environmental Impacts

Some stakeholders discussed how section 401 was important for protecting not just water quality, but
other aspects of the environment.

A couple of stakeholders discussed how the 2020 Rule affected different species. One stakeholder
claimed that the 2020 Rule affected species because it prevented certifying authorities from imposing
conditions that protected endangered species and their habitat (e.g., installing fish ladders, preserving
instream flows, reducing sediment pollution caused by upland activity). The stakeholder also expressed
concern that the time constraints limited certifying authorities' ability to gather sufficient information
about harms to species. Another stakeholder stated that the section 401 certification process was used to
protect endangered species for many years. The stakeholder provided firsthand experiences of how the
section 401 process has played a role in species protection in their region.

One stakeholder emphasized that broad certification authority that existed prior to the 2020 Rule was
instrumental in ensuring that federally licensed and permitted projects proceeded in a manner that
protected important water uses that communities and wildlife relied on (e.g., safe drinking water,
adequate flow, fish passage, and recreational access). This stakeholder emphasized that section 401
authority has been paramount to allowing states and Tribes protect communities and wildlife. The
stakeholder provided an example stating that both Arizona and Colorado imposed conditions in the early
2000s requiring project proponents to offset increase in pollution from their federally permitted activity
by cleaning up pollutants from abandoned mines elsewhere in the watershed.

Agency's Response: See the Agency's Response to Comments in Sections 5,16.6.1.1,
16.6.2.1.

16.6.2.6	Infrastructure

A few stakeholders argued that improving infrastructure and protecting water quality does not have to be
an either-or, and that both can happen simultaneously.

One stakeholder contended the nation would benefit from a clear section 401 certification rule that is
consistent with both statutory text of the CWA and facilitates certifications for clean energy projects and

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considers environmental protection goals. Another stakeholder stated that review under section 401 must
be efficient and predictable to ensure that developers have the certainty needed to develop infrastructure
projects, and that states have the ability to oversee the quality of their waters.

Agency's Response: See the Agency's Response to Comments in Sections 16.6.1.1.

EPA agrees that improving infrastructure and protecting water quality are not mutually
exclusive, and the Agency holds that the final rule clarifies issues such as scope of
certification and the reasonable period of time for a certifying authority to act, which in
turn creates a more efficient, effective, and predictable certifying authority-driven
certification process.

16.6.2.7 Stakeholder Engagement/Consultation

A couple of stakeholders stated that EPA must consult with various organizations prior to new rules being
promulgated as required by the Endangered Species Act (ESA) regarding impacts on imperiled species.
Relatedly, one stakeholder contended that there was no meaningful analysis about the effects on the
environment, including endangered species, prior to the promulgation of the 2020 Rule. The stakeholder
emphasized that EPA must comply with all relevant Federal laws and policies, including the Endangered
Species Act (ESA).

One stakeholder emphasized the importance of states acting as co-regulators and engaging with EPA to
provide feedback on the implementability of a proposed rule.

Agency's Response: See the Agency's Response to Comments in Sections 16.6.1.1.

Consultation under section 7(a)(2) of the ESA may be required when an agency exercises
power under its enabling act to authorize, fund, or carry out an action that may affect listed
species or designated critical habitat. 16 U.S.C. 1536(a)(2); 50 CFR 402.14(a). The
consultation requirement only applies if the agency has discretion under its enabling
legislation to modify the proposed action for the benefit of listed species. See 50 CFR 402.03.
For the reasons discussed below, this rulemaking does not trigger consultation under
section 7(a)(2) of the ESA.

EPA's action addresses various aspects of Section 401, but the Agency's action is limited by
the text of the CWA and congressional intent. Section 7(a)(2) serves as a check on
affirmative action that an agency takes or authorizes under its enabling act, but "does not
expand the powers conferred on an agency by its enabling act." Platte River Whooping
Crane Critical Habitat Maintenance Trust v. FERC, 962 F.2d 27, 33-34 (D.C. Cir. 1992).
Section 7 confers no substantive powers, "EPA cannot invoke the ESA as a means of
creating and imposing requirements that are not authorized by the CWA." Am. Forest &
Paper Ass'n v. EPA, 137 F.3d 291, 299 (5th Cir. 1998).

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Therefore, EPA does not have the discretionary involvement or control over this action that
is necessary to require ESA consultation and the rule does not implicate section 7(a)(2) of
the ESA.

Even assuming the ESA applied, the proposed rule's impacts would not exceed the ESA's
"may affect" threshold and trigger the agencies' section 7(a)(2) consultation duties. The
final rule does not authorize any activity that could affect a listed species or designated
critical habitat. Moreover, the relationship between the final rule (which establishes a
consistent framework for States and Tribes) and any potential effects from future third-
party activities is too attenuated to establish legal causality. See, e.g., 50 CFR 402.17(b)
(providing that "[considerations for determining that a consequence ... is not caused by
the proposed action" include where "(1) [t]he consequence is so remote in time from the
action ... that it is not reasonably certain to occur ... or (3) [t]he consequence is only
reached through a lengthy causal chain that involves so many steps as to make the
consequence not reasonably certain to occur"). The potentially harmful effects of future
third-party projects (i.e., discharges to water that could affect water quality) would only
result from a lengthy causal chain that is too speculative and hypothetical to be
meaningfully analyzed in a consultation on this rulemaking. The consequences of any such
projects would depend on a host of factors unrelated to the final rule, including the specific
federal licenses or permits at issue and the actions of certifying authorities to grant, grant
with conditions, or deny certification requests, the nature of the proposed activity, and the
applicability of other federal, State, and local laws, including section 9 of the ESA. As such,
those future third-party projects—not the final rule—would be the appropriate actions
triggering consultation under the ESA, to the extent that section 7 were found to apply to
those actions. See, e.g., Ctr. for Biological Diversity v. DOI, 563 F.3d 466, 483 (D.C. Cir.
2009) (finding consultation not triggered where agency's approval of leasing program itself
did not affect listed species and species welfare was, "by design, only implicated at later
stages of the program, each of which requires ESA consultation").

EPA engaged with various stakeholders before and during the development of this final
rule. Following the publication of EPA's NOI to revise the 2020 Rule, the Agency opened a
public docket to receive written pre-proposal recommendations for a 60-day period
beginning on June 2, 2021 and concluding on August 2, 2021. See Docket ID No. EPA-HQ-
OW-2021-0302. EPA also held a series of virtual listening sessions for certifying authorities
(June 14, June 23, and June 24, 2021), project applicants (June 15, 2021), and the public
(June 15, and June 23, 2021) to gain further pre-proposal input. See id. at 29544
(announcing EPA's intention to hold multiple webinar-based listening sessions). The
Agency heard from stakeholders representing a diverse range of interests and positions and
received a wide variety of recommendations during this pre-proposal outreach process.
More information about the outreach and engagement conducted by EPA during the pre-
proposal input period can be found in Docket ID No. EPA-HQ-OW-2022-0128. Upon
publishing the proposed rule in the Federal Register, 87 FR 35318, on June 9, 2022, a 60-
day public comment period was initiated. In finalizing the proposed rule, the Agency

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reviewed and considered approximately 27,000 comments received on the proposed
rulemaking from a broad spectrum of interested parties.

16.6.2.8 Justification for 2020 Rule or Revision

A couple of stakeholders, generally in opposition to reconsidering or revising the 2020 Rule, argued that
there is no justification for this action. One stakeholder argued that EPA lacked data on how effective the
2020 Rule was in protecting water quality because it was not in place for long enough to gather the
information. The stakeholder contended that revising the rule should only happen once EPA and regulated
entities have had time for the rule to be in effect. Another stakeholder pointed out that neither EO 13990
nor the Fact Sheet identified any specific problem with the 2020 Rule and that they were "deeply
troubled" by EPA's reconsideration of a significant rule adopted less than one year prior. The stakeholder
also stated that EPA's NOI to Reconsider did not mention any of the "well-documented abuses" that
preceded the implementation of the 2020 rule.

Some stakeholders stated that the section 401 certification process worked for almost 50 years prior to the
promulgation of the 2020 Rule, so there was no need for it to change. One stakeholder argued that there
was no justification for the promulgation of the 2020 Rule in the first place. Another stakeholder further
stated that the Trump administration had neither a legitimate regulatory purpose nor any rational
explanation for its decision to propose the 2020 Rule, nor did they explain how it would be consistent
with EPA's mission or the goals of the CWA. The stakeholder claimed that the 2020 Rule never
explained why the EPA's new conclusions and interpretations were so different from its longstanding
interpretations EPA had stood behind for decades.

Agency's Response: See the Agency's Response to Comments in Sections 16.6.1.1.

The Agency disagrees with commenters asserting that there was no justification for
reconsidering and revising the 2020 Rule. EPA found, and continues to find, it appropriate
to revise the 2020 Rule for several reasons. First, the 2020 Rule does not represent the best
statutory interpretation of fundamental concepts, such as the scope of certification. See
section IV.E of the final rule preamble for further discussion on why the 2020 Rule's
interpretation of the scope of certification is inconsistent with the statutory text of section
401 and authoritative Supreme Court precedent interpreting that text. Further, the 2020
Rule did not align with the broader water quality protection goals of the Act or
Congressional intent behind development and passage of section 401. The 2020 Rule also
failed to appropriately address adverse impacts to state and Tribal water quality, as
evidenced in public comment. See e.g., section IV.E of the final rule preamble for further
discussion on the potential adverse water quality-related impacts of the 2020 Rule's
interpretation of the scope of certification.

The Agency also disagrees with commenters asserting that there was no need to change the
1971 Rule. While the 1971 Rule was in practice for nearly 50 years before the 2020 Rule, the
1971 Rule did not fully reflect the amended statutory language. In addition, following the
promulgation of the 1971 Rule, several seminal court cases have addressed fundamental

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aspects of the water quality certification process, including the scope of certification review
and the appropriate timeframe for certification decisions. The 1971 Rule did not reflect or
account for water quality certification practices or judicial interpretations of section 401
that evolved over the 50 years since 1971.

16.6.2.9 2020 Rule Revision Concerns

Several stakeholders discussed their general concerns regarding the retention of the 2020 Rule during the
revision process. One stakeholder expressed concern about EPA's intention to keep the 2020 Rule in
place for the duration of the two-step rulemaking process and that EPA may use the 2020 Rule as a
starting point and revise it as opposed to completely rewriting it. Another stakeholder stated that the
longer the 2020 Rule is in place, the more harm it will cause to the environment and to the states' ability
to protect it. Another stakeholder argued that leaving the 2020 Rule in place until at least 2023 will result
in additional negative impacts to water quality, delays for project proponents, and wasted resources for
state certifying agencies. A different stakeholder urged EPA to not only issue its revisions as quickly as
possible but to apply its new rule to ongoing certification decisions moving forward. The stakeholder
claimed that applying the new rule to pending projects is both fairer and less disruptive than allowing the
2020 Rule to control decisions made after it has been revised.

One stakeholder advised against efforts to concomitantly make regulatory changes with other Federal
agencies as such an effort to revise other Federal regulations could delay the critical revisions to the 2020
Rule that the stakeholder recommended be finalized as soon as possible, such as rescinding the 2020
Rule.

Conversely, one stakeholder claimed that EPA's plan to revise the 2020 Rule is "misguided" and stated
that EPA must reconsider repealing the 2020 Rule in whole or part prior to undertaking additional
substantive changes.

Agency's Response: See the Agency's Response to Comments in Sections 16.6.6.1.

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