66558 Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Rules and Regulations 

1The CWA defines ‘‘state’’ as ‘‘a State, the District 

of Columbia, the Commonwealth of Puerto Rico, the 

Virgin Islands, Guam, American Samoa, the 

Commonwealth of the Northern Mariana Islands, 

and the Trust Territory of the Pacific Islands.’’ 33 

U.S.C. 1362(3). 2The term ‘‘authorized Tribes’’ refers to Tribes 

that have been approved for ‘‘treatment in a manner 

similar to a State’’ status for CWA section 401. See 

33 U.S.C. 1377(e). 3The 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’’. 

4Water Quality Improvement Act of 1970, Public 

Law 91–224, 84 Stat. 91 (April 3, 1970). 

5S. Rep. 91–351, at 26 (1969) (‘‘Existing law 

declares it to be the intent of Congress that all 

Federal departments, agencies, and 

instrumentalities shall comply with water quality 

standards. This declaration of intent has proved 

unsatisfactory. One basic thrust of S. 7 is to require 

that all activity over which the Federal Government 

has direct control—. . . federally licensed or 

permitted activity—be carried out in a manner to 

assure compliance with applicable water quality 

standards.’’) 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 121, 122, and 124 

[EPA–HQ–OW–2022–0128; FRL–6976.1–03– 

OW] 

RIN 2040–AG12 

Clean Water Act Section 401 Water 

Quality Certification Improvement Rule 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: Following careful 

reconsideration of the water quality 

certification rule the U.S. 

Environmental Protection Agency (EPA 

or the Agency) promulgated in 2020, the 

Agency is finalizing a rule revising and 

replacing the 2020 regulatory 

requirements for water quality 

certification under Clean Water Act 

(CWA) section 401. This final rule 

updates the existing regulations to better 

align with the statutory text and 

purpose of the CWA; to clarify, 

reinforce, and provide a measure of 

consistency with elements of section 

401 certification practice that have 

evolved over the more than 50 years 

since EPA first promulgated water 

quality certification regulations; and to 

support an efficient and predictable 

certification process that is consistent 

with the water quality protection and 

cooperative federalism principles 

central to CWA section 401. An 

Executive order signed on January 20, 

2021, entitled ‘‘Protecting Public Health 

and the Environment and Restoring 

Science to Tackle the Climate Crisis,’’ 

directed the Agency to review the water 

quality certification rule EPA 

promulgated in 2020, and this final rule 

culminates that review. The Agency is 

also finalizing conforming amendments 

to the water quality certification 

regulations for EPA-issued National 

Pollutant Discharge Elimination System 

(NPDES) permits. 

DATES: This action is effective on 

November 27, 2023. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–OW–2022–0128. All 

documents in the docket are listed on 

the https://www.regulations.gov/ 

website. Although listed in the index, 

some information is not publicly 

available, e.g., confidential business 

information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the internet and will be publicly 

available in hard copy form. Publicly 

available docket materials are available 

electronically through https://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Lauren Kasparek, Oceans, Wetlands, 

and Communities Division, Office of 

Water (4504–T), Environmental 

Protection Agency, 1200 Pennsylvania 

Avenue NW, Washington, DC 20460; 

telephone number: 202–564–3351; 

email address: cwa401@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

II. General Information 

A. What action is the Agency taking? 

B. What is the Agency’s authority for 

taking this action? 

C. What are the incremental costs and 

benefits of this action? 

III. Background 

A. Development of Section 401 

B. Overview of Section 401 Requirements 

C. Prior Rulemaking Efforts Addressing 

Section 401 

D. Summary of Stakeholder Outreach 

IV. Final Rule 

A. When Section 401 Certification Is 

Required 

B. Pre-Filing Meeting Request 

C. Request for Certification 

D. Reasonable Period of Time 

E. Scope of Certification 

F. Certification Decisions 

G. Federal Agency Review 

H. EPA’s Roles Under Section 401 

I. Modifications 

J. Enforcement and Inspections 

K. Neighboring Jurisdictions 

L. Treatment in a Similar Manner as a State 

Under Section 401 

M. Implementation Considerations 

N. Severability 

V. Economic Analysis 

VI. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 14094: Modernizing Regulatory 

Review 

B. Paperwork Reduction Act (PRA) 

C. Regulatory Flexibility Act (RFA) 

D. Unfunded Mandates Reform Act 

(UMRA) 

E. Executive Order 13132: Federalism 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

I. National Technology Transfer and 

Advancement Act 

J. Executive Order 12898: Federal Actions 

To Address Environmental Justice in 

Minority Populations and Low-Income 

Populations and Executive Order 14096: 

Revitalizing Our Nation’s Commitment 

to Environmental Justice for All 

K. Congressional Review Act 

I. Executive Summary 

Clean Water Act (CWA) section 401 

provides states 1 and authorized Tribes 2

with a powerful tool to protect the 

quality of their waters from adverse 

impacts resulting from the construction 

and/or operation of federally licensed or 

permitted projects. Under CWA section 

401, a Federal agency may not issue a 

license or permit to conduct any activity 

that may result in any discharge into 

‘‘waters of the United States’’ 3 unless 

the state or authorized Tribe where the 

discharge would originate either issues 

a CWA section 401 water quality 

certification ‘‘that any such discharge 

will comply with the applicable 

provisions of Sections 301, 302, 303, 

306, and 307’’ of the CWA, or waives 

certification. 33 U.S.C. 1341(a)(1). When 

granting a CWA section 401 

certification, CWA section 401(d) 

directs states and authorized Tribes to 

include conditions, including ‘‘effluent 

limitations and other limitations, and 

monitoring requirements,’’ necessary to 

assure that the applicant for a Federal 

license or permit will comply with 

CWA sections 301, 302, 306, and 307, 

and with ‘‘any other appropriate 

requirement of State law.’’ Id. at 

1341(d). 

Congress originally created the water 

quality certification requirement in 

section 21(b) of the Water Quality 

Improvement Act of 1970, which 

amended the Federal Water Pollution 

Control Act (FWPCA).4 Congress 

granted states this certification authority 

in response to Federal agencies’ failure 

to achieve Congress’s previously stated 

goal of assuring that federally licensed 

or permitted activities comply with 

water quality standards.5 Two years 


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6City of Milwaukee v. Illinois, 451 U.S. 304, 310, 

317 (1981). 

7Public Law 92–500, 86 Stat. 816, as amended, 

Public Law 95–217, 91 Stat. 1566, 33 U.S.C. 1251 

et seq. 

8 36 FR 8563 (May 8, 1971), redesignated at 36 FR 

22369, 22487 (November 25, 1971), further 

redesignated at 37 FR 21441 (October 11, 1972), 

further redesignated at 44 FR 32854, 32899 (June 7, 

1979). 

9See Wetlands and 401 Certification: 

Opportunities and Guidelines for States and 

Eligible Indian Tribes (April 1989) (hereinafter, 

1989 Guidance); Clean Water Act Section 401 Water 

Quality Certification: A Water Quality Protection 

Tool for States and Tribes (May 2010) (hereinafter, 

2010 Handbook) (rescinded in 2019, see infra). 

10Clean Water Act Section 401 Certification Rule, 

85 FR 42210 (July 13, 2020) (hereinafter, 2020 

Rule). For further discussion on the 2020 Rule, 

including legal challenges, please see section III of 

this preamble. 

11EPA has defined environmental justice as the 

‘‘fair treatment and meaningful involvement of all 

people regardless of race, color, national origin, or 

income with respect to the development, 

implementation and enforcement of environmental 

laws, regulations and policies.’’ See https://

www.epa.gov/environmentaljustice/learn-aboutenvironmental-justice. 

12See EPA’s Motion for Remand Without Vacatur, 

No. 3:20–cv–04636–WHA (N.D. Cal. July 1, 2021). 

later, Congress revised the Federal water 

quality protection framework 6 when it 

enacted the Federal Water Pollution 

Control Act Amendments of 1972 

(commonly known as the Clean Water 

Act or CWA).7 In those Amendments, 

Congress placed the water quality 

certification requirement in section 401, 

using ‘‘substantially section 21(b) of 

existing law,’’ with relevant conforming 

amendments ‘‘to assure consistency 

with the [ ] changed emphasis from 

water quality standards to effluent 

limitations based on the elimination of 

any discharge of pollutants.’’ S. Rep. No. 

92–414 at 69 (1971); see also H.R. Rep. 

No. 92–911 at 121 (1972) (‘‘Section 401 

is substantially section 21(b) of the 

existing law amended to assure that it 

conforms and is consistent with the new 

requirements of the Federal Water 

Pollution Control Act.’’). 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. 

EPA promulgated implementing 

regulations for water quality 

certification in 1971 (1971 Rule) 8 prior 

to enactment of the 1972 amendments to 

the CWA. In 1979, the Agency 

recognized the need to update its water 

quality certification regulations, in part 

to be consistent with the 1972 

amendments. See 44 FR 32854, 32856 

(June 7, 1979) (noting the 40 CFR part 

121 regulations predated the 1972 

amendments). However, the Agency 

declined to update the regulations at the 

time because it had not consulted with 

other Federal agencies impacted by the 

water quality certification process, and 

instead developed regulations 

applicable to water quality certifications 

on EPA-issued National Pollutant 

Discharge Elimination System (NPDES) 

permits. Id.; see, e.g., 40 CFR 124.53 

through 124.55. As a result, for a 

number of years, the 1971 Rule did not 

fully reflect the amended statutory 

language. Following the promulgation of 

the 1971 Rule, several seminal court 

cases have addressed fundamental 

aspects of the water quality certification 

process, including the scope of 

certification review and the appropriate 

timeframe for certification decisions. 

States have also developed and 

implemented their own water quality 

certification programs and practices 

aimed at protecting waters within their 

borders. During this time, the Agency 

supported state and Tribal water quality 

certification practices and the critical 

role states and Tribes play in protecting 

their waters under section 401.9 But 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. 

EPA revised the 1971 Rule in 2020.10

The 2020 Rule did not update the 

regulations applicable to water quality 

certifications on EPA-issued NPDES 

permits but noted that the Agency 

would ‘‘make any necessary conforming 

regulatory changes in a subsequent 

rulemaking.’’ 85 FR 42219 (July 13, 

2020). The 2020 Rule represented a 

substantive departure from some of the 

Agency’s and certifying authorities’ core 

prior interpretations and practices with 

respect to water quality certification. 

The 2020 Rule also deviated sharply 

from the cooperative federalism 

framework central to section 401 and 

the CWA. While the 2020 Rule 

reaffirmed some of the Agency’s and the 

courts’ prior interpretations, e.g., the 

need for a potential point source 

discharge into waters of the United 

States to trigger the section 401 water 

quality certification requirement, it 

rejected nearly 50 years of Agency 

practice and over 25 years of Supreme 

Court precedent regarding the 

appropriate scope of certification 

review, i.e., rejecting ‘‘activity as a 

whole’’ for the narrower ‘‘dischargeonly’’ approach. Additionally, the 2020 

Rule introduced new procedural 

requirements that disrupted state and 

Tribal certification programs that 

evolved over the last half century. In 

this final rule, the Agency is returning 

to those important core interpretations 

and practices, such as an ‘‘activity’’ 

approach to the scope of certification 

review and greater deference to the role 

of states and Tribes in the certification 

process, while retaining (and adding) 

elements that provide transparency and 

predictability for all stakeholders. 

On January 20, 2021, President Biden 

signed Executive Order 13990 directing 

Federal agencies to review actions taken 

in the prior four years that are, or may 

be, inconsistent with the policies stated 

in the order (including, but not limited 

to, bolstering resilience to climate 

change impacts and prioritizing 

environmental justice).11 Protecting 

Public Health and the Environment and 

Restoring Science to Tackle the Climate 

Crisis, Executive Order 13990, 86 FR 

7037 (published January 25, 2021, 

signed January 20, 2021). Pursuant to 

this Executive order, EPA reviewed the 

2020 Rule. EPA identified substantial 

concerns with several of its provisions 

that were in tension with section 401’s 

cooperative federalism approach to 

ensuring that states and Tribes are 

empowered to protect their water 

quality. See Notice of Intention to 

Reconsider and Revise the Clean Water 

Act Section 401 Certification Rule, 86 

FR 29541, 29542 (June 2, 2021) 

(identifying the Agency’s concerns with 

the 2020 Rule). As a result, the Agency 

announced its intention to revise the 

2020 Rule so that it is (1) well-informed 

by stakeholder input, (2) better aligned 

with the cooperative federalism 

principles that have been central to the 

effective implementation of the CWA, 

and (3) responsive to the environmental 

protection and other objectives outlined 

in Executive Order 13990. Id. 

Five months after EPA’s 

announcement of its intent to reconsider 

and revise the 2020 Rule, on October 21, 

2021, in a legal challenge to the 2020 

Rule, a Federal district court remanded 

and vacated the 2020 Rule. In Re Clean 

Water Act Rulemaking, 568 F. Supp. 3d 

1013 (N.D. Cal. 2021). While EPA had 

not asked the court to vacate the 2020 

Rule,12 the court found that vacatur was 

appropriate ‘‘in light of the lack of 

reasoned decision-making and apparent 

errors in the rule’s scope of certification, 

indications that the rule contravenes the 

structure and purpose of the Clean 

Water Act, and that EPA itself has 

signaled that it could not or would not 

adopt the same rule upon remand.’’ Id. 

at 1026–27. The effect of the court’s 

vacatur was to reinstate the 1971 Rule, 

effective October 21, 2021. Defendantintervenors appealed the vacatur order 

to the U.S. Court of Appeals for the 

Ninth Circuit. On April 6, 2022, the U.S. 

Supreme Court granted the defendantVerDate Sep<11>2014 19:27 Sep 26, 2023 Jkt 259001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\FR\FM\27SER2.SGM 27SER2

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13The Court’s stay order does not alter EPA’s 

legal conclusions discussed in this final rule. The 

request for a stay concerned only the 

appropriateness of the district court’s vacatur of a 

rule before a decision on the merits. The stay 

request did not raise any issues related to the 

substance of CWA section 401 certification or the 

merits of the 2020 Rule. See Application for Stay 

Pending Appeal in Louisiana v. Am. Rivers, No. 

21A539, pp. 1, 4, 16 (March 21, 2022) (identifying 

‘‘the core issue in this case’’ to be the 

appropriateness of the district court’s vacatur order) 

(identifying the Administrative Procedure Act 

(APA)—not the CWA or section 401—as the 

statutory provision involved in the application for 

stay) (starting the application for stay with the 

question: ‘‘Can a single district court vacate a rule 

that an agency adopted through notice-andcomment rulemaking without first finding that the 

rule is unlawful?’’). Neither the Court’s majority— 

which did not issue an opinion explaining its stay 

order—nor the dissent discussed any aspect of 

section 401 certification or the 2020 Rule. 

14The court found that ‘‘the district court lacked 

the authority to vacate the 2020 Rule without first 

holding it unlawful.’’ In Re Clean Water Act 

Rulemaking, 60 F.4th 583, 596 (9th Cir. 2023). The 

court did not address the merits of the 2020 Rule, 

noting that it could not ‘‘engage in the factfinding 

that might be needed to identify any harms that 

keeping the 2020 Rule in place during a remand 

might cause. . . .’’ Id. 

intervenors’ application for a stay of the 

vacatur pending the Ninth Circuit 

appeal. Louisiana v. Am. Rivers, 142 S. 

Ct. 1347 (2022).13 As a result of the 

Supreme Court’s stay, the 2020 Rule 

once again applied to section 401 

certifications. On February 21, 2023, the 

U.S. Court of Appeals for the Ninth 

Circuit reversed the district court’s 

remand with vacatur order and 

remanded the case back to the U.S. 

District Court for the Northern District 

of California for further proceedings.14

As a result of the Ninth Circuit’s 

decision, the 2020 Rule applies until 

this final rule goes into effect. 

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. The Agency is 

also finalizing conforming amendments 

to the water quality certification 

regulations for EPA-issued NPDES 

permits. 

II. General Information 

A. What action is the Agency taking? 

In this action, the Agency is 

publishing a final rule to replace its 

currently effective water quality 

certification regulations at 40 CFR part 

121 and to make conforming edits in 40 

CFR parts 122 and 124. 

B. What is the Agency’s authority for 

taking this action? 

The authority for this action is the 

Federal Water Pollution Control Act, 33 

U.S.C. 1251 et seq., including but not 

limited to sections 101(d), 304(h), 401, 

402, and 501(a). 

C. What are the incremental costs and 

benefits of this action? 

The Agency prepared the Economic 

Analysis for the Final ‘‘Clean Water Act 

Section 401 Water Quality Certification 

Improvement Rule’’ (‘‘Economic 

Analysis for the Final Rule’’), which 

evaluates the potential costs and 

benefits and is available in the 

rulemaking docket. The analysis is 

summarized in section V in this 

preamble. The Economic Analysis for 

the Final Rule is qualitative due to 

significant limitations and uncertainties 

associated with estimating the 

incremental costs and benefits of the 

final rule. See section V of this preamble 

for further discussion. 

III. Background 

A. Development of Section 401 

In 1965, Congress amended the 

Federal Water Pollution Control Act 

(FWPCA) to require states, or, where a 

state failed to act, the newly created 

Federal Water Pollution Control 

Administration, to promulgate water 

quality standards for interstate waters 

within each state. Water Quality Act of 

1965, Public Law 89–234, 79 Stat. 903 

(October 2, 1965). These standards were 

meant ‘‘to protect the public health or 

welfare, enhance the quality of water 

and serve the purposes of [the] Act,’’ 

which included ‘‘enhanc[ing] the 

quality and value of our water resources 

and [] establish[ing] a national policy for 

the prevention, control, and abatement 

of water pollution.’’ Id. Yet, only a few 

years later, while debating potential 

amendments to the FWPCA, Congress 

observed that, despite that laudable 

national policy, states faced obstacles to 

achieving these newly developed water 

quality standards because of an 

unexpected source: Federal agencies. 

Instead of helping states cooperatively 

achieve these Federal policy objectives, 

Federal agencies were ‘‘sometimes . . . 

a culprit with considerable 

responsibility for the pollution problem 

which is present.’’ 115 Cong. Rec. 9011, 

9030 (April 15, 1969). 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). As a result, states, 

industry groups, conservation groups, 

and the public alike ‘‘questioned the 

justification for requiring compliance 

with water quality standards’’ if Federal 

agencies themselves would not comply 

with those standards. Id. at 7. 

In response to such concerns, 

Congress introduced language that 

would bolster state 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). Under this 

new provision, instead of relying on the 

Federal Government to ensure 

compliance with water quality 

standards, states would be granted the 

power to certify that there was 

reasonable assurance that federally 

licensed or permitted activities would 

meet water quality standards before 

such a Federal license or permit could 

be issued. Ultimately, Congress added 

this new provision as section 21(b) of 

the Water Quality Improvement Act of 

1970, Public Law 91–224, 84 Stat. 91 

(April 3, 1970). 

Under section 21(b)(1), applicants for 

Federal licenses or permits were 

required to obtain state certification that 

there was reasonable assurance that any 

federally licensed or permitted activity 

that may result in any discharge into 

navigable waters would not violate 

applicable water quality standards. Id. 

Additionally, section 21(b) also 

provided a role for other potentially 

affected states, discussed scenarios 

under which state certification for both 

Federal construction and operation 

licenses or permits may be necessary, 

and provided an opportunity for a 

Federal license or permit to be 

suspended for violating applicable 

water quality standards. Section 21(b) 

embodied the cooperative federalism 

principles from the 1965 amendments 

by providing states with the opportunity 

to influence, yet not ‘‘frustrate,’’ the 

Federal licensing or permitting process. 

See 115 Cong. Rec. 28875, 28971 

(October 7, 1969) (noting the idea of 

state certification ‘‘[arose] out of policy 

of the 1965 Act that the primary 

responsibility for controlling water 

pollution rests with the States’’); see 

also H.R. Rep. No. 91–940, at 54–55 

(March 24, 1970) (Conf. Rep) (adding a 

timeline for state certification ‘‘[i]n 

order to insure that sheer inactivity by 

the State . . . will not frustrate the 

Federal application’’). 

In 1972, with the enactment of the 

Clean Water Act, Congress significantly 


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15City of Milwaukee v. Illinois, 451 U.S. 304, 310, 

317 (1981). 

16 33 U.S.C. 1251(b). 

17The conference report noted that ‘‘[t]he 

inserting of section 303 into the series of sections 

listed in section 401 is intended to mean that a 

federally licensed or permitted activity, including 

discharge permits under section 402, must be 

certified to comply with State water quality 

standards adopted under section 303. The inclusion 

of section 303 is intended to clarify the 

requirements of section 401. It is understood that 

section 303 is required by the provisions of section 

301. Thus, the inclusion of section 303 in section 

401 while at the same time not including section 

303 in the other sections of the Act where sections 

301, 302, 306, and 307 are listed is in no way 

intended to imply that 303 is not included by 

reference to 301 in those other places in the Act, 

such as sections 301, 309, 402, and 509 and any 

other point where they are listed. Section 303 is 

always included by reference where section 301 is 

listed.’’ Id. 

revised the statutory water quality 

protection framework.15 Clean Water 

Act, Public Law 92–500, 86 Stat. 816, as 

amended, Public Law 95–217, 91 Stat. 

1566, 33 U.S.C. 1251 et seq. While doing 

so, Congress reaffirmed ‘‘the primary 

responsibilities and rights of States to 

prevent, reduce, and eliminate 

pollution.’’ 16 To this end, the 1972 

amendments included section 401, 

which Congress considered to be 

‘‘substantially section 21(b) of the 

existing law amended to assure that it 

conforms and is consistent with the new 

requirements of the Federal Water 

Pollution Control Act.’’ H.R. Rep. No. 

92–911, at 121 (1972). These ‘‘new 

requirements’’ of the 1972 Act reflected 

a ‘‘changed emphasis from water quality 

standards to effluent limitations based 

on the elimination of any discharge of 

pollutants.’’ S. Rep. No. 92–414, at 69 

(1971). As a result, unlike section 21(b), 

which focused only on compliance with 

water quality standards, section 401 

required applicants for Federal licenses 

and permits to obtain state certification 

of compliance with the newly enacted 

provisions focused on achieving effluent 

limitations. 33 U.S.C. 1341(a)(1). A few 

years later, Congress amended section 

401 to correct an omission from the 

1972 statute and clarify that it still 

intended for states to also certify 

compliance with water quality 

standards. See H.R. Rep. No. 95–830, at 

96 (1977) (inserting section 303 in the 

list of applicable provisions throughout 

section 401).17

Section 401 of the 1972 Act also 

introduced a new subsection, subsection 

(d), that explicitly provided states with 

the ability to include ‘‘effluent 

limitations and other limitations, and 

monitoring requirements’’ in their 

certification to assure that the applicant 

will comply not only with sections 301, 

302, 306, and 307, but also with ‘‘any 

other appropriate requirement of State 

law.’’ Id. at 1341(d). In subsection (d), 

Congress also provided that any 

certification ‘‘shall become a condition 

on any Federal license or permit.’’ Id.; 

see also S. Rep. No. 92–414, at 69 (1971) 

(‘‘The certification provided by a State 

in connection with any Federal license 

or permit must set forth effluent 

limitations and monitoring 

requirements necessary to comply with 

the provisions of this Act or under State 

law and such a certification becomes an 

enforceable condition on the Federal 

license or permit.’’). Consistent with 

Congress’s intent to empower states to 

protect their waters from the effects of 

federally licensed or permitted projects, 

this provision ‘‘assure[d] that Federal 

licensing or permitting agencies cannot 

override State water quality 

requirements.’’ S. Rep. No. 92–414, at 69 

(1971). 

B. Overview of Section 401 

Requirements 

Under CWA section 401, a Federal 

agency may not issue a license or permit 

to conduct any activity that may result 

in any discharge into waters of the 

United States, unless the certifying 

authority where the discharge would 

originate either issues a CWA section 

401 water quality certification or waives 

certification. 33 U.S.C. 1341(a)(1). The 

applicant for the Federal license or 

permit that requires section 401 

certification is responsible for obtaining 

certification or a waiver from the 

certifying authority, which could be a 

state, territory, authorized Tribe, or 

EPA, depending on where the discharge 

originates. To initiate the certification 

process, Federal license or permit 

applicants must submit a ‘‘request for 

certification’’ to the appropriate 

certifying authority. The certifying 

authority must act upon the request 

within a ‘‘reasonable period of time 

(which shall not exceed one year).’’ Id. 

Additionally, during the reasonable 

period of time, certifying authorities 

must comply with public notice 

procedures established for certification 

requests, and where appropriate, 

procedures for public hearings. Id. 

If a certifying authority determines 

that the activity will comply with the 

listed provisions in section 401(a)(1), it 

may grant or waive certification. See 

section IV.E in this preamble for further 

discussion on the scope of certification. 

When granting a CWA section 401 

certification, certifying authorities must 

include conditions (e.g., ‘‘effluent 

limitations and other limitations, and 

monitoring requirements’’) pursuant to 

CWA section 401(d) necessary to assure 

that the applicant for a Federal license 

or permit will comply with applicable 

provisions of CWA sections 301, 302, 

306, and 307, and with ‘‘any other 

appropriate requirement of State law.’’ 

33 U.S.C. 1341(d). If a certifying 

authority grants certification with 

conditions, those conditions are 

incorporated into the Federal license or 

permit. Id. Once an applicant provides 

a Federal agency with a certification, the 

Federal agency may issue the license or 

permit. Id. at 1341(a)(1). 

If a certifying authority is unable to 

provide such certification, the certifying 

authority may deny or waive 

certification. If certification is denied, 

the Federal agency cannot issue the 

Federal license or permit. If certification 

is waived, the Federal agency may issue 

the Federal license or permit. Certifying 

authorities may waive certification 

expressly, or they may waive 

certification by ‘‘fail[ing] or refus[ing] to 

act on a request for certification within 

a reasonable period of time.’’ Id. Either 

way, the Federal licensing or permitting 

agency may issue the Federal license or 

permit. 

Although Congress provided section 

401 certification authority to the 

jurisdiction in which the discharge 

originates, Congress also recognized that 

another state or authorized Tribe’s water 

quality may be affected by the 

discharge, and it created an opportunity 

for such a state or authorized Tribe to 

raise objections to, and request a hearing 

on, the Federal license or permit. See id. 

at 1341(a)(2). Section 401(a)(2) requires 

the Federal agency to ‘‘immediately 

notify’’ EPA ‘‘upon receipt’’ of a 

‘‘[license or permit] application and 

certification.’’ Id. EPA in turn has 30 

days from that notification to determine 

whether the discharge ‘‘may affect’’ the 

water quality of any other state or 

authorized Tribe. Id. If the Agency 

makes a ‘‘may affect’’ determination, it 

must notify the other state or authorized 

Tribe, the Federal agency, and the 

applicant. The other state or authorized 

Tribe then has 60 days to determine 

whether the discharge will violate its 

water quality requirements. If the other 

state or authorized Tribe makes such a 

determination within those 60 days, it 

must notify EPA and the Federal 

agency, in writing, of its objection(s) to 

the issuance of the Federal license or 

permit and request a public hearing. Id. 

The Federal licensing or permitting 

agency is responsible for holding the 

public hearing. At the hearing, EPA is 

required to submit its evaluation and 

recommendations regarding the 

objection. Based on the 

recommendations from the objecting 

state or authorized Tribe and EPA’s own 

evaluation and recommendation, as well 

as any evidence presented at the 


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18Section 401(a)(3) identifies the bases a 

certifying authority may rely upon for finding that 

there is no longer reasonable assurance. These are 

changes after certification was granted in: 

construction or operation of the facility, 

characteristics of the water where the discharge 

occurs, or the applicable water quality criteria or 

effluent limits or other requirements. Id. at 

1341(a)(3). 

19Each Federal licensing or permitting agency 

may have its own regulations regarding additional 

processes for suspending a license or permit. 

20 If the documents provided are insufficient to 

make the determination, the Regional Administrator 

can request any supplemental information ‘‘as may 

be required to make the determination.’’ 40 CFR 

121.12 (2019). 

hearing, the Federal agency is required 

to condition the license or permit ‘‘in 

such manner as may be necessary to 

ensure compliance with applicable 

water quality requirements.’’ Id. The 

Federal license or permit may not be 

issued ‘‘if the imposition of conditions 

cannot ensure such compliance.’’ Id. 

Section 401 also addresses when an 

applicant must provide separate 

certifications for a facility’s Federal 

construction license or permit and any 

necessary Federal operating license or 

permit. Under section 401(a)(3), an 

applicant 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].’’ Id.18

Sections 401(a)(4) and (a)(5) describe 

circumstances where the certified 

Federal license or permit may be 

suspended by the Federal agency. First, 

a Federal agency may suspend a license 

or permit where a certifying authority 

determines during a pre-operation 

inspection of the facility or activity that 

it will violate applicable water quality 

requirements. Id. at 1341(a)(4). This preoperation inspection and possible 

suspension apply only where a facility 

or activity does not require a separate 

operating Federal license or permit. 

Under section 401, the Federal agency 

may not suspend the license or permit 

unless it holds a public hearing.19 Id. 

Once a Federal license or permit is 

suspended, it must remain suspended 

until the certifying authority notifies the 

Federal agency that there is reasonable 

assurance that the facility or activity 

will not violate applicable water quality 

requirements. Id. Second, a Federal 

agency may suspend or revoke a 

certified license or permit upon the 

entering of a judgment under the CWA 

that the facility or activity violated 

applicable provisions of section 301, 

302, 303, 306, or 307 of the CWA. Id. at 

1341(a)(5). 

Section 401 not only identifies the 

roles and obligations of Federal license 

or permit applicants, certifying 

authorities, and Federal agencies, it also 

provides specific roles for EPA. First, 

EPA may act as a certifying authority 

where a state or authorized Tribe ‘‘has 

no authority to give such certification.’’ 

Id. at 1341(a)(1). Second, as discussed 

above, EPA is responsible for notifying 

other states or authorized Tribes that 

may be affected by a discharge from a 

federally licensed or permitted activity, 

and where required, for providing an 

evaluation and recommendations on 

such other state or authorized Tribe’s 

objections. Id. at 1341(a)(2). Lastly, EPA 

is responsible for providing technical 

assistance upon request from Federal 

agencies, certifying authorities, or 

Federal license or permit applicants. Id. 

at 1341(b). 

C. Prior Rulemaking Efforts Addressing 

Section 401 

In the last 50 plus years, EPA has 

undertaken two rulemaking efforts 

focused solely on addressing water 

quality certification, one of which 

preceded the 1972 amendments to the 

CWA. The Agency has also developed 

several guidance documents on the 

section 401 process. This section of the 

preamble discusses EPA’s major 

rulemaking and guidance efforts over 

the last 50 plus years, including most 

recently the 2020 Rule and EPA’s 

review of it pursuant to Executive Order 

13990. 

1. 1971 Rule 

In February 1971, EPA proposed 

regulations implementing section 401’s 

predecessor provision, section 21(b) of 

the FWPCA. 36 FR 2516 (February 5, 

1971). Those proposed regulations were 

divided into four subparts, one of which 

provided ‘‘definitions of general 

applicability for the regulations and 

. . . provide[d] for the uniform content 

and form of certification.’’ Id. The other 

three subparts focused on EPA’s roles. 

Id. In May 1971, after receiving public 

comments, EPA finalized the water 

quality certification regulations with the 

proposed four-part structure at 18 CFR 

part 615. 36 FR 8563 (May 8, 1971) 

(‘‘1971 Rule’’). 

The first subpart of the 1971 Rule 

(subpart A) established requirements 

that applied generally to all 

stakeholders in the certification process, 

including an identification of 

information that all certifying 

authorities must include in a 

certification. According to the 1971 

Rule, a certifying authority was required 

to include several components in a 

certification, including the name and 

address of the project applicant; a 

statement that the certifying authority 

either examined the Federal license or 

permit application or examined other 

information from the project applicant 

and, based upon that evaluation, 

concluded that ‘‘there is reasonable 

assurance that the activity will be 

conducted in a manner which will not 

violate applicable water quality 

standards;’’ any conditions that the 

certifying authority deemed ‘‘necessary 

or desirable for the discharge of the 

activity;’’ and any other information the 

certifying authority deemed appropriate. 

40 CFR 121.2(a) (2019). Additionally, 

the 1971 Rule allowed for modifications 

to certifications upon agreement by the 

certifying authority, the Federal 

licensing or permitting agency, and 

EPA. Id. at § 121.2(b) (2019). 

The second subpart of the 1971 Rule 

(subpart B) established a process for 

EPA to provide notification of potential 

water quality effects to other potentially 

affected jurisdictions. Under the 1971 

Rule, the Regional Administrator was 

required to review the Federal license or 

permit application, the certification or 

waiver, and, where requested by EPA, 

any supplemental information provided 

by the Federal licensing or permitting 

agency.20 If the Regional Administrator 

determined that there was ‘‘reason to 

believe that a discharge may affect the 

quality of the waters of any State or 

States other than the State in which the 

discharge originates,’’ the Regional 

Administrator would notify each 

affected state within 30 days of receipt 

of the application materials and 

certification. Id. at §§ 121.13, 121.16 

(2019). In cases where the Federal 

licensing or permitting agency held a 

public hearing on the objection raised 

by an affected jurisdiction, the Federal 

agency was required to forward notice 

of such objection to the Regional 

Administrator no later than 30 days 

prior to the hearing. Id. at § 121.15 

(2019). At the hearing, the Regional 

Administrator was required to submit 

an evaluation and ‘‘recommendations as 

to whether and under what conditions 

the license or permit should be issued.’’ 

Id. 

Subpart B also provided that 

certifying authorities may waive the 

certification requirement under two 

circumstances: first, when the certifying 

authority sends written notification 

expressly waiving its authority to act on 


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a request for certification; and second, 

when the Federal licensing or 

permitting agency sends written 

notification to the EPA Regional 

Administrator that the certifying 

authority failed to act on a certification 

request within a reasonable period of 

time after receipt of such a request. Id. 

at § 121.16 (2019). The 1971 Rule 

provided that the Federal licensing or 

permitting agency determined what 

constitutes a ‘‘reasonable period of 

time,’’ and that the period shall 

generally be six months, but in any 

event no more than one year. Id. at 

§ 121.16(b) (2019). 

The third subpart of the 1971 Rule 

(subpart C) established requirements 

that only applied when EPA acted as the 

certifying authority, including 

identifying specific information that 

must be included in a certification 

request. The project applicant was 

required to submit to the EPA Regional 

Administrator a signed request for 

certification that included a ‘‘complete 

description of the discharge involved in 

the activity for which certification is 

sought,’’ which included five items: the 

name and address of the project 

applicant, a description of the facility or 

activity and of any related discharge 

into waters of the United States, a 

description of the function and 

operation of wastewater treatment 

equipment, dates on which the activity 

and associated discharge would begin 

and end, and a description of the 

methods to be used to monitor the 

quality and characteristics of the 

discharge. Id. at § 121.22 (2019). Once 

the request was submitted to EPA, the 

Regional Administrator was required to 

provide public notice of the request and 

an opportunity to comment. The 1971 

Rule specifically stated that ‘‘[a]ll 

interested and affected parties will be 

given reasonable opportunity to present 

evidence and testimony at a public 

hearing on the question whether to grant 

or deny certification if the Regional 

Administrator determined that such a 

hearing is necessary or appropriate.’’ Id. 

at § 121.23 (2019). If, after consideration 

of relevant information, the Regional 

Administrator determined that there 

was ‘‘reasonable assurance that the 

proposed activity will not result in a 

violation of applicable water quality 

standards,’’ the Regional Administrator 

would issue the certification. Id. at 

§ 121.24 (2019). 

The fourth and final subpart of the 

1971 Rule (subpart D) provided that the 

Regional Administrator ‘‘may, and upon 

request shall’’ provide Federal licensing 

and permitting agencies with 

information regarding water quality 

standards and advise them as to the 

status of compliance by dischargers 

with the conditions and requirements of 

applicable water quality standards. Id. 

at § 121.30 (2019). 

In November 1971, EPA reorganized 

and transferred several regulations, 

including the water quality certification 

regulations, into title 40 of the Code of 

Federal Regulations. EPA subsequently 

redesignated the water quality 

certification regulations twice in the 

1970s. See 36 FR 22369, 22487 

(November 25, 1971), redesignated at 37 

FR 21441 (October 11, 1972), further 

redesignated at 44 FR 32854, 32899 

(June 7, 1979). The last redesignation 

effort was part of a rulemaking that 

extensively revised the Agency’s NPDES 

regulations. In the revised NPDES 

regulations, EPA addressed water 

quality certifications on EPA-issued 

NPDES permits separately from the 

1971 Rule. EPA acknowledged that the 

1971 Rule was ‘‘in need of revision’’ 

because the ‘‘substance of these 

regulations predates the 1972 

amendments to the Clean Water Act.’’ 

44 FR 32880 (June 7, 1979). However, 

EPA declined to revise the 1971 Rule 

because it had not consulted the other 

Federal agencies impacted by the water 

quality certification process. Id. at 

32856. Instead, the Agency finalized 

regulations applicable only to 

certification on EPA-issued NPDES 

permits. Id. at 32880. EPA developed 

these regulations, which included a 

default reasonable period of time of 60 

days, limitations on certification 

modifications, and requirements for 

certification conditions, in response to 

practical challenges and issues arising 

from certification on EPA-issued 

permits. Id. Ultimately, despite the 

changes Congress made to the statutory 

text in 1972 and opportunities the 

Agency had to revisit the regulatory text 

during redesignation efforts in the 

1970s, EPA did not substantively 

change the 1971 Rule until 2020. 

2. EPA Guidance on 1971 Rule 

Although EPA did not pursue any 

additional rulemaking efforts until 2019, 

the Agency issued three national 

guidance documents on the water 

quality certification process set forth in 

the 1971 Rule. The first and second 

guidance documents recognized the 

vital role section 401 certification can 

play in protecting state and Tribal water 

quality, sought to inform states and 

Tribes how to use the certification 

program to protect their waters, and 

explained how to leverage available 

resources to operate or expand their 

certification programs. These 

documents provided states and Tribes 

with background on the certification 

process, discussed the relevant case law, 

and identified data sources that could 

inform the certification review process. 

Additionally, both documents provided 

tangible examples of state and Tribal 

experiences with section 401 that could 

inform other states and Tribes interested 

in developing their certification 

programs. 

The first guidance document, issued 

in 1989, focused on how states and 

Tribes could use water quality 

certifications to protect wetlands. 

Wetlands and 401 Certification: 

Opportunities and Guidelines for States 

and Eligible Indian Tribes (April 1989) 

(‘‘1989 Guidance’’). While the 1989 

Guidance focused on the use of water 

quality certifications in lieu of, or in 

addition to, state or Tribal wetlands 

regulatory programs, it provided helpful 

background information on the 

certification process in general. It also 

highlighted various state programs and 

water quality certification practices to 

demonstrate how other certifying 

authorities could approach the 

certification process. For example, the 

1989 Guidance highlighted a 

certification denial issued by the thenPennsylvania Department of 

Environmental Resources to illustrate 

that ‘‘all of the potential effects of a 

proposed activity on water quality— 

direct and indirect, short and long term, 

upstream and downstream, construction 

and operation—should be part of a 

State’s certification review.’’ Id. at 22– 

23. Additionally, the 1989 Guidance 

discussed considerations states and 

Tribes could examine when developing 

their own section 401 implementing 

regulations, as well as programs and 

resources states and Tribes could look to 

for technical support when making 

certification decisions. Id. at 30–37. 

The second guidance document, 

issued in 2010, reflected the 

development of case law and state and 

Tribal program experiences over the two 

decades following the 1989 Guidance. 

Clean Water Act Section 401 Water 

Quality Certification: A Water Quality 

Protection Tool for States and Tribes 

(May 2010) (‘‘2010 Handbook’’) 

(rescinded in 2019). Instead of focusing 

on certifications in the context of 

wetland protection, the 2010 Handbook 

described more broadly how the 

certification process could help states 

and Tribes achieve their water quality 

goals. Like the 1989 Guidance, the 2010 

Handbook discussed the certification 

process, using state and Tribal programs 

as examples, and explored methods and 

means for states and Tribes to leverage 

available funding, staffing, and data 

sources to fully implement a water 

quality certification program. EPA 


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21Updating Regulations on Water Quality 

Certifications, 84 FR 44080 (August 22, 2019). 

22 In Re Clean Water Act Rulemaking, No. 3:20– 

cv–04636–WHA (N.D. Cal.); Delaware Riverkeeper 

et al. v. EPA, No. 2:20–cv–03412 (E.D. Pa.); S.C. 

Coastal Conservation League v. EPA, No. 2:20–cv– 

03062 (D.S.C.). 

23The two other courts also remanded the 2020 

Rule to EPA, but without vacatur. Order, Delaware 

Riverkeeper v. EPA, No. 2:20–cv–03412 (E.D. Pa. 

August 6, 2021) (determining that vacatur was not 

appropriate because the court ‘‘has not yet, and will 

not, make a finding on the substantive validity of 

the Certification Rule’’); Order, S.C. Coastal 

Conservation League v. EPA, No. 2:20–cv–03062 

(D.S.C. August 2, 2021) (remanding without 

vacating). 

rescinded the 2010 Handbook on June 7, 

2019, concurrent with the publication of 

the third guidance document. 

EPA issued the third guidance 

document in 2019 pursuant to Executive 

Order 13868. Clean Water Act Section 

401 Guidance for Federal Agencies, 

States and Authorized Tribes (June 

2019) (‘‘2019 Guidance’’) (rescinded). 

The 2019 Guidance was meant to 

‘‘facilitate consistent implementation of 

section 401 and 1971 certification 

regulations’’ based on the view that the 

2010 Handbook did not ‘‘reflect current 

case law interpreting CWA section 401.’’ 

85 FR 42213. The 2019 Guidance 

focused on three topics: (1) timeline for 

certification review and action, (2) the 

scope of section 401, and (3) the 

information within the scope of a 

certifying authority’s review. 2019 

Guidance at 1. EPA rescinded the 2019 

Guidance on July 13, 2020, concurrent 

with the publication of the final 2020 

Rule. 

3. Development of the 2020 Rule 

In addition to directing EPA to review 

its 2010 Handbook and issue new 

section 401 guidance, Executive Order 

13868, entitled Promoting Energy 

Infrastructure and Economic Growth, 

also directed EPA to propose new 

regulations governing section 401 

consistent with the policy set forth in 

the order to ‘‘promote private 

investment in the Nation’s energy 

infrastructure.’’ 84 FR 13495, 13496 

(April 15, 2019). It is noteworthy that, 

even in the context of directing EPA to 

initiate changes to a water quality 

protection rule, the executive order did 

not direct the Agency to consider the 

water quality consequences of any such 

changes. EPA issued the proposed rule 

on August 22, 2019.21 EPA promulgated 

a final rule on July 13, 2020. Clean 

Water Act Section 401 Certification 

Rule, 85 FR 42210 (July 13, 2020) 

(‘‘2020 Rule’’). 

The 2020 Rule reaffirmed that Federal 

agencies unilaterally set the reasonable 

period of time, clarified that the 

certification requirement was triggered 

by a point source discharge from a 

federally licensed or permitted activity 

into ‘‘waters of the United States,’’ and 

reaffirmed that certifying authorities 

may explicitly waive certification. The 

2020 Rule also introduced several new 

features, including one that allowed 

Federal agencies to review certification 

decisions for compliance with the 2020 

Rule’s requirements and, if the 

certification decision did not comply 

with these requirements, allowed 

Federal agencies to deem such noncompliant certifications as waived. The 

2020 Rule also prohibited a certifying 

authority from requesting a project 

applicant to withdraw and resubmit a 

certification request and rejected the 

scope of certification review (‘‘activity 

as a whole’’) affirmed by the Supreme 

Court in PUD No. 1 of Jefferson County 

v. Washington Department of Ecology, 

511 U.S. 700 (1994), in favor of a more 

limiting interpretation (‘‘dischargeonly’’ approach) favored by two 

dissenting Justices in that case. 

Following publication, the 2020 Rule 

was challenged in three Federal district 

courts by states, Tribes, and nongovernmental organizations.22 Industry 

stakeholders and eight states intervened 

on behalf of EPA to defend the 2020 

Rule. On October 21, 2021, following 

briefing and a hearing on EPA’s motion 

for remand without vacatur, the U.S. 

District Court for the Northern District 

of California both remanded and 

vacated the 2020 Rule. In re Clean Water 

Act Rulemaking, 568 F. Supp. 3d 1013 

(N.D. Cal. 2021) (reversed and 

remanded by 60 F.4th 583 (9th Cir. 

2023)). The court found that vacatur was 

appropriate ‘‘in light of the lack of 

reasoned decision-making and apparent 

errors in the rule’s scope of certification, 

indications that the rule contravenes the 

structure and purpose of the Clean 

Water Act, and that EPA itself has 

signaled that it could not or would not 

adopt the same rule upon remand.’’ Id. 

at 1026–27. The court order required a 

temporary return to EPA’s 1971 Rule 

until EPA finalized a new rule.23 After 

the Ninth Circuit denied intervenors’ 

motion for stay pending appeal on 

February 24, 2022, intervenors filed an 

application for a stay of the vacatur 

pending appeal in the Supreme Court 

on March 21, 2022. On April 6, 2022, 

the U.S. Supreme Court granted the 

application for a stay of the vacatur 

pending resolution of the appeal of the 

vacatur in the Ninth Circuit. Louisiana 

v. Am. Rivers, No. 21A539 (S. Ct. April 

6, 2022). On February 21, 2023, the 

Ninth Circuit reversed the remand with 

vacatur and remanded the case back to 

the U.S. District Court for the Northern 

District of California for further 

proceedings. In Re Clean Water Act 

Rulemaking, No. 21–16958 (9th Cir. 

February 21, 2023). 

4. Executive Order 13990 and Review of 

the 2020 Rule 

On January 20, 2021, President Biden 

signed Executive Order 13990, 

Protecting Public Health and the 

Environment and Restoring Science to 

Tackle the Climate Crisis (Order). 86 FR 

7037 (published January 25, 2021, 

signed January 20, 2021). The Order 

provides that ‘‘[i]t is, therefore, the 

policy of my Administration to listen to 

the science; to improve public health 

and protect our environment; to ensure 

access to clean air and water; to limit 

exposure to dangerous chemicals and 

pesticides; to hold polluters 

accountable, including those who 

disproportionately harm communities of 

color and low-income communities; to 

reduce greenhouse gas emissions; to 

bolster resilience to the impacts of 

climate change; to restore and expand 

our national treasures and monuments; 

and to prioritize both environmental 

justice and the creation of the wellpaying union jobs necessary to deliver 

on these goals.’’ Id. at 7037, Section 1. 

The Order ‘‘directs all executive 

departments and agencies (agencies) to 

immediately review and, as appropriate 

and consistent with applicable law, take 

action to address the promulgation of 

Federal regulations and other actions 

during the last 4 years that conflict with 

these important national objectives, and 

to immediately commence work to 

confront the climate crisis.’’ Id. ‘‘For any 

such actions identified by the agencies, 

the heads of agencies shall, as 

appropriate and consistent with 

applicable law, consider suspending, 

revising, or rescinding the agency 

actions.’’ Id., section 2(a). The Order 

also revoked Executive Order 13868 of 

April 10, 2019 (Promoting Energy 

Infrastructure and Economic Growth), 

which initiated development of the 

2020 Rule, and specifically identified 

the 2020 Rule for review. See Fact 

Sheet: List of Agency Actions for 

Review, available at https://

www.whitehouse.gov/briefing-room/ 

statements-releases/2021/01/20/factsheet-list-of-agency-actions-for-review/ 

(last visited on January 27, 2022). 

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 


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24For example, commenters noted that use of the 

2020 Rule’s procedural requirements on 

certifications for the Army Corps of Engineers’ 

(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. 

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. 

Agencies have inherent authority to 

reconsider past decisions and to revise, 

replace, or repeal a decision to the 

extent permitted by law and supported 

by a reasoned explanation. FCC v. Fox 

Television Stations, Inc., 556 U.S. 502, 

515 (2009) (‘‘Fox’’); Motor Vehicle Mfrs. 

Ass’n of the U.S., Inc. v. State Farm 

Mutual Automobile Ins. Co., 463 U.S. 

29, 42 (1983); see also Encino 

Motorcars, LLC v. Navarro, 579 U.S. 

211, 221 (2016) (‘‘Agencies are free to 

change their existing policies as long as 

they provide a reasoned explanation for 

the change.’’). Such a decision need not 

be based upon a change of facts or 

circumstances. A revised rulemaking 

based ‘‘on a reevaluation of which 

policy would be better in light of the 

facts’’ is ‘‘well within an agency’s 

discretion.’’ Nat’l Ass’n of Home 

Builders v. EPA, 682 F.3d 1032, 1038 & 

1043 (D.C. Cir. 2012) (citing Fox, 556 

U.S. at 514–15). The Agency reviewed 

the 2020 Rule, determined that the rule 

should be replaced, and proposed a 

replacement rule. Some commenters on 

the proposed rule opposed 

reconsideration of the 2020 Rule and 

asserted that EPA did not provide a 

basis for reconsideration of the 2020 

Rule. EPA disagrees. 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 in this 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.24 See 

e.g., section IV.E of this 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. 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. 

D. Summary of Stakeholder Outreach 

Following the publication of EPA’s 

notice of intent 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. The 

Agency received nearly 3,000 

recommendations from members of the 

public, which can be found in the preproposal docket. See Docket ID No. 

EPA–HQ–OW–2021–0302. The Federal 

Register publication requested feedback 

related to key issues identified during 

implementation of the 2020 Rule, 

including but not limited to issues 

regarding pre-filing meeting requests, 

certification requests, reasonable period 

of time, scope of certification, 

certification actions and Federal agency 

review, enforcement, modifications, 

neighboring jurisdictions, data and 

other information, and implementation 

coordination. See 86 FR 29543–44 (June 

2, 2021). 

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). EPA 

also met with stakeholders upon request 

during development of the proposed 

rule. 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. 

Additionally, EPA also met with other 

Federal licensing and permitting 

agencies to solicit feedback on the 

Federal Register publication. At the 

virtual listening sessions, the Agency 

gave a presentation that provided 

background on section 401 and prior 

Agency actions and sought input on the 

Agency’s intent to revise the 2020 Rule 

and the specific issues included in the 

Federal Register publication described 

above. 

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. Some 

certifying authorities expressed concern 

about the limited role of states and 

Tribes under the 2020 Rule, and they 

called for increased flexibility in 

implementing section 401 to fully 

protect their water resources. During the 

project proponent listening session, 

project proponents shared feedback 

about the need to streamline the 

certification process and recommended 

that the new rule prevent delays in 

determining certification decisions. In 

the public listening sessions, speakers 

from non-governmental environmental 

and water conservation organizations 

reinforced the idea that states and 

Tribes should be accorded greater 

deference in the certification process. 

An overarching theme articulated by 

many speakers from various stakeholder 

groups was the need for EPA’s new rule 

to provide increased guidance and 

clarity. 

The Agency also initiated a Tribal 

consultation and coordination process 

on June 7, 2021. The Agency engaged 

with Tribes over a 90-day consultation 

period during development of the 


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25See § 121.1(c), (f) (defining ‘‘Federal agency’’ to 

mean ‘‘any agency of the Federal Government to 

which application is made for a Federal license or 

permit that is subject to Clean Water Act section 

401,’’ and similarly defining ‘‘license or permit’’ to 

mean ‘‘any license or permit issued or granted by 

an agency of the Federal Government to conduct 

any activity which may result in any discharge into 

waters of the United States’’). 

26 40 CFR 121.1(d) (2020). 

27 40 CFR 121.1(k) (2020). 

proposed rule that concluded on 

September 7, 2021, including two Tribal 

consultation kickoff webinars on June 

29, 2021, and July 7, 2021. The Agency 

received consultation letters from eight 

Tribes and three Tribal organizations. 

The Agency did not receive any requests 

for consultation during that time, 

although several Tribes expressed an 

interest in receiving additional 

information and ongoing engagement 

throughout the rulemaking process. 

Several Tribes commented that the 2020 

Rule impaired or undermined Tribal 

sovereignty and their ability to protect 

Tribal waters. Many Tribes provided 

input regarding section 401 certification 

process improvements. Most Tribes 

were generally positive about a 

provision for a pre-filing meeting 

request, however, some had concerns 

that the 30-day wait period (before a 

project proponent could request 

certification) is very rigid and preferred 

flexibility in allowing certifying 

authorities to waive the 30-day 

requirement. Some Tribes expressed 

‘‘the reasonable period of time’’ should 

start when the application is deemed 

complete, not when the initial request 

for certification is received. Most Tribes 

argued that the 2020 Rule’s narrowing of 

the scope of certification was 

inconsistent with congressional intent 

for Tribes and states to have an effective 

tool to protect the quality of waters 

under their jurisdiction. A few Tribal 

organizations expressed concern that 

current implementation of section 

401(a)(2) does not protect off-reservation 

treaty rights from discharges. Additional 

information about the Tribal 

consultation process can be found in 

section VI.F in this preamble and the 

‘‘Summary Report of Tribal 

Consultation and Engagement for the 

Clean Water Act Section 401 Water 

Quality Certification Improvement 

Rule,’’ which is available in the docket 

for this final rule. 

The Agency signed a proposed rule 

updating the CWA section 401 water 

quality certification process on June 1, 

2022. On June 9, 2022, the Agency 

published the proposed rulemaking in 

the Federal Register, 87 FR 35318 (June 

9, 2022), 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 rule. A complete 

response to comments document is 

available in the docket for this rule 

(Docket ID No. EPA–HQ–OW–2022– 

0128). 

IV. Final Rule 

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 is 

finalizing revisions to the section 401 

regulations to better align its regulations 

with the cooperative federalism and 

water quality protection principles 

enshrined in the text and legislative 

history of the CWA. Additionally, the 

final rule provides greater clarity and 

acknowledgment of essential water 

quality protection concepts from 

Executive Order 13990. In addition to 

providing a necessary regulatory reset 

on significant issues such as the scope 

of certification, the reasonable period of 

time, and Federal agency review, the 

Agency is finalizing its revisions to 

clarify and update the regulatory text to 

foster a more efficient and predictable 

certification process. As demonstrated 

by the extensive pre-proposal and 

proposed rule outreach, this rulemaking 

is well-informed by stakeholder input 

on all aspects of the section 401 

certification process. 

In addition to the revisions to part 

121, EPA is also finalizing conforming 

changes to the part 124 regulations 

governing CWA section 401 

certifications for EPA-issued NPDES 

permits. The final part 121 regulations 

apply to all Federal licenses or permits 

subject to CWA section 401 

certification, including EPA-issued 

NPDES permits.25 The purpose of these 

conforming changes is to ensure that the 

part 124 regulations are consistent with 

the revised provisions of part 121. In the 

proposal for this rule, EPA requested 

comment on whether the Agency had 

identified all changes to the part 124 

regulations that conflict or potentially 

conflict with the proposal and therefore 

warrant amendment. EPA is finalizing 

targeted revisions to specific provisions 

of the NPDES regulations at 40 CFR 

124.53, 124.54, and 124.55 that 

implement section 401. Specifically, 

EPA is finalizing targeted revisions to 40 

CFR 124.53(b) through (e), 124.54(a) and 

(b), and 124.55(a) through (d). In 

addition, EPA is finalizing targeted 

conforming revisions to the regulations 

at 40 CFR 122.4(b), 122.44(d)(3), and 

122.62(a)(3)(iii). EPA explains in further 

detail the reasons for each conforming 

change (beyond mere technical 

revisions) in the preamble discussion at 

sections IV.C, IV.D, IV.E, IV.F, IV.G, and 

IV.I of this preamble. 

EPA is also finalizing several 

revisions to the definitions section of 

the final rule at § 121.1. EPA is 

finalizing minor revisions to the 

definition of ‘‘Administrator,’’ located at 

§ 121.1(a), to remove the reference to 

authorized representatives. Instead, the 

Agency is adding a separate definition 

for ‘‘Regional Administrator.’’ See 

§ 121.1(i). The Agency is removing the 

definition for ‘‘certification,’’ which was 

located at § 121.1(b) in the 2020 Rule, 

because it is not necessary to define the 

term. Additionally, the Agency is 

removing the definitions for ‘‘certified 

project’’ 26 and ‘‘proposed project’’ 27

because the final rule does not include 

those terms. EPA is also clarifying the 

roles of the stakeholders in the 

certification process. First, the Agency 

is finalizing non-substantive 

modifications to the definition of 

‘‘Federal agency’’ located at final rule 

§ 121.1(c). Second, the Agency is 

retaining the term ‘‘project proponent’’ 

from the 2020 Rule to define the 

stakeholder seeking certification. 40 

CFR 121.1(h). While the term 

‘‘applicant’’ is used in section 401, that 

term does not clearly reflect and include 

all the stakeholders who might seek 

certification. For example, Federal 

agencies themselves (and not third-party 

applicants) seek section 401 

certification on the issuance of general 

permits (e.g., Corps’ Nationwide 

Permits, EPA’s Construction General 

Permits). Additionally, contractors or 

other agents often seek certification on 


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28For ease of discussion and comprehension, the 

Agency uses the term ‘‘discharge’’ interchangeably 

with the more precise ‘‘discharge from a point 

source’’ or ‘‘point source discharge.’’ As discussed 

in section IV.A.2.c of this preamble, several years 

after PUD No. 1, the Ninth Circuit clarified that the 

type of ‘‘discharge’’ that triggers section 401’s 

certification requirement is a ‘‘point source’’ 

discharge. ONDA v. Dombeck, 172 F.3d 1092 (9th 

Cir. 1998). 

29 33 U.S.C. 1342(b). 

30 33 U.S.C. 1344(g). 

31The Corps also requires section 401 

certification for its civil works projects, even though 

there is no Federal license or permit associated with 

those projects. The Corps’ current regulations 

require the Corps to seek section 401 certification 

for discharges of dredged material or fill into waters 

of the United States. See 33 CFR 336.1(a)(1) (‘‘The 

CWA requires the Corps to seek state water quality 

certification for discharges of dredged or fill 

material into waters of the U.S.’’); 33 CFR 335.2 

Continued 

behalf of a project applicant. The term 

‘‘project proponent’’ 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 National Pollutant Discharge 

Elimination System (NPDES) permit). 

Lastly, the Agency is finalizing nonsubstantive changes to the definition of 

‘‘certifying authority’’ located at final 

rule § 121.1(b). Other revisions to 

regulatory definitions are discussed 

throughout this preamble. 

This section of the final rule preamble 

includes 12 sub-sections that each 

discuss: (1) the final rule provisions, (2) 

a summary of the Agency’s final rule 

rationale and public comments (where 

applicable), and (3) implementation 

considerations for the final rule 

provisions (where applicable). Section 

IV.A of this preamble discusses when 

section 401 certification is required. 

Sections IV.B through IV.F of this 

preamble walk readers through the 

section 401(a)(1) certification process in 

chronological order (i.e., pre-filing 

meeting request through the 

certification decision). Section IV.G of 

this preamble discusses the Federal 

agency review process that follows the 

section 401(a)(1) certification process. 

Section IV.K of this preamble discusses 

the section 401(a)(2) neighboring 

jurisdictions process that occurs after 

the section 401(a)(1) certification 

process (if the certification was granted 

or waived), but before the Federal 

license or permit may be issued. 

Sections IV.I through IV.J of this 

preamble discuss events that may occur 

after the certification is granted until the 

Federal license or permit expires, 

including certification modifications 

(section IV.I of this preamble) and 

enforcement and inspection (section IV.J 

of this preamble). Section IV.H of this 

preamble discusses EPA’s roles under 

section 401, including EPA’s role as the 

certifying authority. Section IV.L of this 

preamble discusses the new provisions 

for Tribes to obtain treatment in a 

similar manner as a state (TAS) for 

section 401 or section 401(a)(2). Section 

IV.M of this preamble discusses general 

implementation considerations for this 

final rule. Lastly, section IV.N discusses 

severability of this final rule. This final 

rule is structured in a manner to clearly 

and transparently convey to 

stakeholders the CWA section 401 

certification and post-certification 

processes. 

A. When Section 401 Certification Is 

Required 

1. What is the Agency finalizing? 

EPA is finalizing the regulatory text 

located at final rule § 121.2 to affirm 

that a ‘‘[c]ertification or waiver is 

required for any Federal license or 

permit that authorizes any activity 

which may result in any discharge from 

a point source into waters of the United 

States.’’ 40 CFR 121.2. The regulatory 

text clarifies the circumstances under 

which a section 401 certification is 

required and is consistent with the 

Agency’s longstanding interpretation of 

section 401, including in the 2020 Rule, 

that an applicant for a Federal license or 

permit to conduct any activity that may 

result in any discharge from a point 

source 28 into waters of the United 

States must obtain a section 401 

certification or waiver. The Agency 

made minor revisions to the proposed 

text at § 121.2 to better match the 

statutory language in section 401(a)(1) 

and clarify when certification is 

required, including adding the word 

‘‘Federal’’ before license or permit, 

‘‘any’’ before both ‘‘activity’’ and 

‘‘discharge,’’ and changing from ‘‘a 

water of the United States’’ to ‘‘waters 

of the United States.’’ To be clear, these 

changes do not represent a change in 

substance from proposal. 

2. Summary of Final Rule Rationale and 

Public Comment 

a. Federally Licensed or Permitted 

Activity 

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). The 

Agency is retaining the 2020 Rule’s 

definition for a ‘‘license or permit’’ with 

minor modifications to clarify that 

section 401 is required for any federally 

licensed or permitted activity which 

may result in any discharge into waters 

of the United States. EPA is also adding 

the word ‘‘Federal’’ before ‘‘license or 

permit’’ throughout the final rule to 

further clarify that the license or permit 

subject to certification must be Federal. 

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. This conclusion is 

supported by the legislative history of 

CWA section 401, which noted that 

‘‘since permits granted by States under 

section 402 are not Federal permits—but 

State permits—the certification 

procedures are not applicable.’’ H.R. 

Rep. No. 92–911, at 127 (1972). 

Additionally, the legislative history of 

the CWA amendments of 1977, 

discussing state assumption of section 

404, noted that ‘‘[t]he conferees wish to 

emphasize that such a State program is 

one which is established under State 

law and which functions in lieu of the 

Federal program. It is not a delegation 

of Federal authority.’’ H.R. Rep. No. 95– 

830, at 104 (1977). 

Section 401 certification is not 

required for licenses or permits issued 

by a state or Tribe that administers a 

federally approved permit program. For 

example, states and Tribes may be 

authorized to administer the section 402 

NPDES permitting program 29 or the 

section 404 dredge and fill permitting 

program.30 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. 

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. The most 

common examples of Federal licenses or 

permits that may be subject to section 

401 certification are CWA section 402 

NPDES permits issued by EPA in 

jurisdictions where the EPA administers 

the NPDES permitting program; CWA 

section 404 permits for the discharge of 

dredged or fill material permits issued 

by the Army Corps of Engineers as well 

as Rivers and Harbors Act sections 9 

and 10 permits issued by the Army 

Corps of Engineers; and hydropower 

and interstate natural gas pipeline 

licenses issued by the Federal Energy 

Regulatory Commission (FERC).31 See 


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(‘‘[T]he Corps does not issue itself a CWA permit 

to authorize Corps discharges of dredged material 

or fill material into U.S. waters but does apply the 

404(b)(1) guidelines and other substantive 

requirements of the CWA and other environmental 

laws.’’). In these instances, EPA understands that 

the Corps will follow the certification process as 

described in the final rule. 

32 40 CFR 121.1(f) (2020). 

33 In the context of section 404, the Corps does 

the day-to-day work of conducting jurisdictional 

determinations though EPA has final administrative 

authority over the scope of CWA jurisdiction. 

Administrative Authority to Construe § 404 of the 

Federal Water Pollution Control Act (‘‘Civiletti 

Memorandum’’), 43 Op. Att’y Gen. 197 (1979). 

section IV.A.3 infra for further 

discussion on the types of Federal 

licenses or permits subject to section 

401. 

b. Potential for a Discharge To Occur 

Consistent with the 2020 Rule and the 

proposal, a certification or waiver is 

required for any Federal license or 

permit that authorizes any activity 

which may result in any discharge from 

a point source into waters of the United 

States. 40 CFR 121.2. The presence of, 

or potential for, a discharge is a key 

determinant for when a water quality 

certification is required. 33 U.S.C. 

1341(a)(1) (‘‘A certification is required 

for ‘‘a Federal license or permit to 

conduct any activity . . . which may 

result in any discharge into the 

navigable waters . . .’’) (emphasis 

added); see 40 CFR 121.2. Most 

commenters supported the clarification 

in proposed § 121.2 that section 401 is 

triggered by a point source discharge as 

well as when any Federal license or 

permit authorizes any activity that may 

result in any point source discharge. A 

few commenters, seeming to refer to the 

proposal preamble as opposed to 

regulatory text, expressed concern that 

the addition of the word ‘‘potential’’ 

would change the universe of projects 

requiring 401 certification; EPA 

disagrees. EPA’s approach is consistent 

with the plain language of the statutory 

phrase ‘‘may result in any 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. This approach is also 

consistent with the Agency’s 

longstanding implementation of section 

401. See, e.g., 85 FR 42236 (July 13, 

2020) (‘‘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, see 

supra) (‘‘It is important to note that 

[section] 401 is triggered by the 

potential for a discharge; an actual 

discharge is not required.’’). 

EPA requested comment on whether 

it should develop 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. Some 

commenters asserted that EPA should 

not develop such a process because 

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. Conversely, 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 for various 

reasons, asserting that such a process 

would allow for consistent 

implementation. 

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 

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. 

c. Discharge 

Consistent with the Agency’s 

longstanding position and the 2020 

Rule, EPA is finalizing that a discharge 

from a point source (or ‘‘point source 

discharge’’), or potential for one, is 

required to trigger section 401. See 40 

CFR 121.2. Additionally, the Agency is 

clarifying that, consistent with S.D. 

Warren v. Maine Board of 

Environmental Protection, 547 U.S. 370 

(2006), discussed below, a point source 

discharge triggering section 401 does 

not require the addition of pollutants. 

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’’ 32 and instead 

incorporating those definitional 

concepts into the regulatory text at final 

rule § 121.2, which discusses when 

certification is required. This simpler 

approach will provide greater clarity 

about the nature of discharges that 

trigger the need for section 401 

certification or waiver. 

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) 

(emphasis added). The CWA defines 

‘‘discharge of a pollutant’’ to mean ‘‘any 

addition of any pollutant to navigable 

waters from any point source.’’ Id. at 

1362(12). EPA and the Corps 33 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.’’ Many commenters 

supported the Agency’s clear 

articulation of its longstanding 

interpretation that any discharge 

triggering a section 401 certification 

does not require an addition of 

pollutants. On the other hand, some 

commenters argued that eliminating the 

requirement that there be an addition of 

pollutants goes beyond the plain 

language of CWA section 401. As an 

initial matter, 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.’’). 

EPA strongly disagrees that the plain 

language of section 401 requires that 

any discharge triggering section 401 

include an addition of pollutants. As 

discussed above, the statutory definition 

of ‘‘discharge’’ is broad and is not 

limited to a discharge of pollutants. 

Additionally, as discussed below, this 

interpretation is consistent with the text 


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34 In ONDA, the United States took the position 

that the term ‘‘discharge’’ at 33 U.S.C. 1362(14) did 

not include nonpoint sources because there was 

nothing in the definition or the legislative history 

of the term that suggested it extended to nonpoint 

source pollution. Brief of the United States in Or. 

Natural Desert Ass’n v. Dombeck, Nos. 97–3506, 

97–35112, 97–35115, at 18–21 (9th Cir. 1997). 

Additionally, the United States argued that section 

401’s legislative history did not suggest that 

‘‘discharge’’ included nonpoint sources. Id. at 23– 

24. 

35See section IV.E of this preamble for further 

discussion of on PUD No 1. 

36Following the Supreme Court’s decision in S.D. 

Warren that the addition of a pollutant was not 

needed to trigger section 401, the Ninth Circuit 

reaffirmed its earlier decision that section 401 was 

only triggered by a discharge from a point source. 

Or. Natural Desert Ass’n v. USFS, 550 F.3d 778 (9th 

Cir. 2008). The Ninth Circuit held that ‘‘[n]either 

the ruling nor the reasoning in S.D. Warren is 

inconsistent with this court’s treatment of nonpoint 

sources in [section] 401 of the Act, as explained in 

[ONDA].’’ Id. at 785. 

37The United States argued that section 401 

requires the discharge to be from a point source in 

briefs filed before the Ninth Circuit. See, e.g., Briefs 

of the United States in ONDA v. Dombeck, Nos. 97– 

3506, 97–35112, 97–35115 (9th Cir. 1997), ONDA 

v. USFS, No. 08–35205 (9th Cir. 2008). 

38The CWA defines point source as ‘‘any 

discernible, confined and discrete conveyance, 

including but not limited to any pipe, ditch, 

channel, tunnel, conduit, well, discrete fissure, 

container, rolling stock, concentrated animal 

feeding operation, or vessel or other floating craft.’’ 

33 U.S.C. 1362(14). 

39See, 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). 

of the statute as interpreted by the U.S. 

Supreme Court. 

In S.D. Warren, a hydropower dam 

operator asserted that its dams did not 

result in discharges that would require 

section 401 certification because the 

dams only released water that ‘‘adds 

nothing to the river that was not there 

above the dams.’’ 547 U.S. 370, 374–75, 

378 (2006). The Court stated that the 

term discharge is broader than 

‘‘discharge of a pollutant’’ and 

‘‘discharge of pollutants.’’ Id. Observing 

that the term ‘‘discharge’’ is not 

specifically defined in the statute, the 

Court applied the ordinary dictionary 

meaning, ‘‘flowing or issuing out.’’ Id. In 

applying this meaning to hydroelectric 

dams, the Court held that releasing 

water through a dam constituted a 

discharge for purposes of section 401 

and, thus, the CWA provided states with 

the ability to address water quality 

impacts from these releases through the 

certification process. Id. at 385–86. The 

Court explicitly rejected the argument 

that an ‘‘addition’’ was necessary for a 

‘‘discharge,’’ stating ‘‘[w]e disagree that 

an addition is fundamental to any 

discharge.’’ Id. at 379 n.5. 

While the Supreme Court has held 

that the addition of a pollutant is not 

necessary for a discharge to prompt the 

need for a CWA section 401 

certification, the Ninth Circuit has held 

that such certification-triggering 

discharges must be from point sources. 

Or. Natural Desert Ass’n (ONDA) v. 

Dombeck, 172 F.3d 1092, 1095–99 (9th 

Cir. 1998) (‘‘ONDA’’).34 In ONDA, the 

Ninth Circuit addressed the issue of 

whether ‘‘the term ‘discharge’ in 

[section 401] includes releases from 

nonpoint sources as well as releases 

from point sources.’’ Id. at 1094–95. The 

court held that the ‘‘term ‘discharge’ in 

[section 401] is limited to discharges 

from point sources.’’ Id. at 1097. The 

court found its holding to be consistent 

with the Supreme Court’s holding in 

PUD No. 1. 511 U.S. 700 (1994).35 The 

court in ONDA found that although PUD 

No. 1 held that certification conditions 

may address water quality impacts from 

the certified activity beyond its 

discharges, a triggering discharge is still 

required for section 401 to apply and 

‘‘PUD No. 1 did not broaden the 

meaning of the term ‘discharge’ under 

§ 1341.’’ Id. at 1098–99.36 EPA has 

consistently implemented the Ninth 

Circuit’s interpretation of section 401 as 

requiring the potential for a point source 

discharge (with or without the addition 

of pollutants) to trigger section 401. See 

85 FR 42238; 2010 Handbook at 5–6 

(rescinded in 2019, see supra) 

(discussing requirement of section 401 

certification when there is a point 

source discharge).37

EPA is finalizing the text at § 121.2, 

including the phrase ‘‘from a point 

source,’’ because it is consistent with 

the case law discussed above 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.38 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.39

Several commenters supported adding 

the phrase ‘‘from a point source’’ at 

proposed § 121.2. These commenters 

stated that the change is consistent with 

applicable case law and the text and 

structure of the CWA. In addition, these 

commenters appreciated that EPA 

clarified that section 401 was triggered 

by any discharge from a point source 

versus a discharge from a nonpoint 

source. Conversely, other commenters 

opposed adding the phrase ‘‘from a 

point source’’ at proposed § 121.2, 

arguing that EPA’s reliance on the 

definition of point source at 33 U.S.C. 

1362(14) implicitly requires the 

addition of pollutants to trigger section 

401 certification in contravention of SD 

Warren. The commenters also asserted 

that it appears to conflict with EPA’s 

concurrent proposal that the scope of 

review is restored to the ‘‘activity as a 

whole.’’ A few 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. 

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) 

(emphasis added). 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 in this 

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 this section of the 

preamble and will continue to do so in 

implementation of the final rule. 

Many commenters who provided 

input on this topic urged EPA to revise 

the regulation to include discharges 

from both point and nonpoint sources. 


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40 In County of Maui, Hawaii v. Hawaii Wildlife 

Fund, et al., the Supreme Court addressed the 

question of whether the CWA requires a NPDES 

permit under section 402 of the Act when 

pollutants originate from a point source and travel 

through groundwater before reaching navigable 

waters. 140 S. Ct. 1462 (2020). The Court held that 

‘‘the statute requires a permit when there is a direct 

discharge from a point source into navigable waters 

or when there is the functional equivalent of a 

direct discharge.’’ Id. at 1476 (emphasis in original). 

The Court articulated several factors that may prove 

relevant for purposes of determining whether a 

section 402 permit is required. Id. at 1476–77. 

Consistent with the rationale of the Court’s decision 

in County of Maui, any point source discharge that 

is the functional equivalent of a direct discharge to 

navigable waters would also trigger section 401 if 

a Federal agency issues the applicable license or 

permit. 

These commenters stated that the term 

‘‘discharge’’ as used throughout the 

CWA means something broader than 

discharges from point sources, citing SD 

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 discharges from nonpoint 

sources will ensure that states and 

Tribes are able to exercise their section 

401 authority to protect water quality 

from federally licensed or permitted 

activities that would result in a 

nonpoint source discharge. One 

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, while 

another commenter asserted that the 

Federal Government and the Supreme 

Court recognized that all discharges 

trigger section 401. 

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 above, the ONDA court held 

that the ‘‘term ‘discharge’ in [section 

401] is limited to discharges from point 

sources.’’ Id. at 1097. EPA also disagrees 

that the Federal Government has 

recognized that all discharges trigger 

section 401. As noted above, this was 

the Federal Government’s position 

before the Ninth Circuit in ONDA, see 

footnote 37, 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. 

d. ‘‘Into the Navigable Waters’’ 

Consistent with the 2020 Rule and 

proposal, 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 40 

CFR 121.2. 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). Requiring section 401 

certification for any federally licensed 

or permitted activity that may result in 

any discharge into waters of the United 

States is consistent with the plain 

language of section 401(a)(1) and 

legislative history of the CWA. See H.R. 

Rep. No. 91–911, at 124 (1972) (‘‘It 

should be clearly noted that the 

certifications required by section 401 

are for activities which may result in 

any discharge into navigable waters.’’). 

This reading is also consistent with the 

Agency’s longstanding position and 

practice. See, e.g., 2010 Handbook at 3, 

5 (rescinded in 2019, see supra) (‘‘Since 

[section] 401 certification only applies 

where there may be a discharge into 

waters of the [United States], how states 

or tribes designate their own waters 

does not determine whether [section] 

401 certification is required.’’). 

Potential discharges into state or 

Tribal waters that are not ‘‘waters of the 

United States’’ do not trigger the 

requirement to obtain section 401 

certification. However, as discussed in 

section IV.E in this preamble, 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. 

3. Implementation 

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. These may 

include, but are not limited to, CWA 

section 404 permits issued by the Corps 

for the discharge of dredge or fill 

material, Rivers and Harbors Act section 

10 permits issued by the Corps for 

construction of wharfs, piers, etc., 

Rivers and Harbors Act section 9 

permits issued by the Corps (for the 

construction of dams and dikes) and the 

Coast Guard (for construction of bridges 

and causeways), FERC licenses for the 

construction and operation of nonFederal hydropower projects, FERC 

certificates for the construction and 

operation of interstate natural gas 

pipeline projects, shoreline permits 

issued by the Tennessee Valley 

Authority for shoreline construction 

activities, EPA-issued CWA section 402 

permits for the discharge of pollutants, 

nuclear power plant licenses issued by 

Nuclear Regulatory Commission, 

permits for wineries and distilleries 

issued by the Alcohol and Tobacco Tax 

and Trade Bureau, and mine plans of 

operation for mining activities on 

National Forest Service Lands approved 

by the Forest Service. See also 

Economic Analysis for the Final Rule at 

section 3.4. As discussed above, the 

operative question is whether the 

federally licensed or permitted activity 

may result in any discharge into waters 

of the United States. 

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). Several commenters requested 

clarification that the section 401 

certification process only applies to 

individual Federal licenses or permits. 

Another commenter said that it is not 

clear how the proposed rule would 

apply to nationwide permits and state 

programmatic permits, and further 

suggested that these permits be 

exempted from the rule. EPA disagrees 

with these comments. 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 


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41 If a certifying authority denies certification on 

an EPA-issued NPDES general permit, dischargers 

could always apply for an individual NPDES 

permit. That individual permit would also require 

a 401 certification. 

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) and (e)(2) (2020) (describing 

requirements for certification on the 

issuance of a general license or permit); 

2010 Handbook at 29–30 (rescinded in 

2019, see supra) (discussing the 

application of section 401 to general 

permits). Accordingly, EPA cannot 

adopt commenter suggestions to exempt 

general permits from the certification 

process. 

Several commenters requested that 

EPA affirmatively state that the section 

401 certification process does not apply 

to ‘‘verifications’’ of Federal general 

permit actions; instead, commenters 

suggested that the certification process 

should occur at the time the Federal 

general permit is issued. Federal 

agencies seek certification on general 

permits before the permits are issued. 

Accordingly, final rule § 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.41 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 § 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. 

As discussed above, section 401 is 

triggered by a potential point source 

discharge from a federally licensed or 

permitted activity into waters of the 

United States. A few commenters 

recommended that the Agency 

explicitly acknowledge that point 

sources include discharges from CWA 

section 404 dredge and fill activities 

(e.g., equipment, construction activities) 

in the regulatory text. Considering the 

broad applicability of section 401 to all 

Federal licenses or permits, the Agency 

does not find it necessary to focus the 

regulatory text on point sources from 

one type of federally licensed or 

permitted activity. Rather, the Agency 

intends to rely on the definition of point 

source at 33 U.S.C. 1362(14), which 

defines point source as ‘‘any 

discernible, confined and discrete 

conveyance . . . from which pollutants 

are or may be discharged.’’ As 

emphasized above, a point source does 

not require the addition of pollutants, 

but rather is a conveyance from which 

pollutants are or may be discharged. For 

example, a point source includes the 

turbine or tailrace of a hydroelectric 

dam, and bulldozers or other 

construction equipment. In both 

instances, the equipment (e.g., turbine, 

bulldozer) acts as a discernable, 

confined, or discrete conveyance that 

pollutants could be discharged from, but 

the addition or existence of such 

pollutants is not necessary for the 

equipment to be considered a point 

source. 

B. Pre-Filing Meeting Request 

1. What is the Agency finalizing? 

EPA is finalizing the requirement that 

‘‘[t]he project proponent shall request a 

pre-filing meeting with the certifying 

authority at least 30 days prior to 

submitting a request for certification in 

accordance with the certifying 

authority’s applicable submission 

procedures, unless the certifying 

authority waives or shortens the 

requirement for the pre-filing meeting 

request.’’ 40 CFR 121.4. This 

requirement will ensure that certifying 

authorities have an opportunity, should 

they desire it, to receive early 

notification and to discuss the project 

with the project proponent before the 

statutory timeframe for review begins. If 

a certifying authority does not 

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. The Agency is not 

defining the ‘‘applicable submission 

procedures’’ or other procedural aspects 

of a pre-filing meeting request or 

subsequent meeting. Accordingly, the 

Agency is finalizing the removal of the 

2020 Rule’s recommendations for prefiling meetings. See 40 CFR 121.4(c) and 

(d) (2020). The Agency is also finalizing 

the removal of regulatory text discussing 

the certifying authority’s obligations in 

response to a pre-filing meeting request 

because the final rule does not compel 

any action by the certifying authority. 

See 40 CFR 121.4(b) (2020). 

2. Summary of Final Rule Rationale and 

Public Comment 

The 2020 Rule introduced the prefiling 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 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)) provided additional justification 

in this context to interpret the term 

‘‘request for certification’’ to allow EPA 

to require a pre-filing meeting request. 

The 2020 Rule proposal originally 

limited the pre-filing meeting request 

requirement to project proponents 

seeking certification in jurisdictions 

where EPA acts as the certifying 

authority. However, in response to 

stakeholder feedback on the proposed 

2020 Rule, the Agency extended the prefiling meeting request requirement to all 

project proponents. As a result, the final 

2020 Rule required all project 

proponents to request a pre-filing 

meeting at least 30 days prior to 

submitting a water quality certification 


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request. 85 FR 42241 (July 13, 2020). 

The 2020 Rule did not provide any 

mechanism for certifying authorities to 

waive or otherwise alter the 30-day 

period between a project proponent 

requesting a pre-filing meeting and 

subsequently submitting a certification 

request. Instead, there was a mandatory 

30-day period that had to pass before 

the project proponent could submit a 

certification request. 

During pre-proposal outreach on this 

rulemaking, some stakeholders found 

the pre-filing meeting request 

requirement to be essential to an 

efficient certification process, while 

others expressed concern about the 

mandatory 30-day ‘‘waiting period’’ 

between the pre-filing meeting request 

and the certification request, 

particularly in emergency permit 

situations. Stakeholders suggested that 

EPA should add flexibility to the 

process and give certifying authorities 

the ability to waive the pre-filing 

meeting request (e.g., for smaller and 

less complex projects and emergencies). 

In response to pre-proposal input, the 

Agency proposed to retain a pre-filing 

meeting request provision with 

modifications to provide certifying 

authorities the flexibility to waive or 

shorten this requirement. 

Many commenters recognized that 

pre-filing meetings have the potential to 

facilitate and help streamline the 

certification process through early 

coordination. Conversely, other 

commenters expressed concern that the 

pre-filing meeting request requirement 

creates delays and administrative 

burden. Some commenters said that, in 

lieu of an actual requirement, EPA 

should only encourage pre-filing 

meeting requests. Several commenters 

supported the flexibility included in the 

proposed rule giving certifying 

authorities the ability to waive or 

shorten the requirement. 

After considering public comment, 

EPA is finalizing the pre-filing meeting 

request requirement as proposed, with 

minor, non-substantive revisions. 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. 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. 

EPA requested comment on whether 

it should define the pre-filing meeting 

request process and ‘‘applicable 

submission procedures’’ for other 

certifying authorities in regulatory text. 

A few commenters stated that there 

should be procedures for the pre-filing 

meeting requests to increase clarity and 

consistency, including a list of 

minimum information to include in the 

meeting request. Other commenters 

opposed the idea of EPA setting 

procedures for pre-filing meetings to 

maintain flexibility. EPA finds that 

certifying authorities are best equipped 

to determine their procedures and needs 

for pre-filing meetings and requests. 

Like the approach taken under the 2020 

Rule, EPA is not defining the process or 

manner to submit pre-filing meeting 

requests. Rather, EPA intends the term 

‘‘applicable submission procedures’’ to 

mean the submission procedures 

deemed appropriate by the certifying 

authority. See infra for discussion on 

EPA’s applicable submission procedures 

when EPA acts as the certifying 

authority. The Agency is also not 

defining a pre-filing meeting process 

(e.g., identifying meeting subject matter 

or meeting participants) nor retaining 

the 2020 Rule’s recommendations for 

pre-filing meetings. In the 2020 Rule, 

the Agency ‘‘encouraged’’ but did not 

require the project proponent and the 

certifying authority to take certain steps 

with respect to the pre-filing meeting 

process. See 40 CFR 121.4(c) and (d) 

(2020). The Agency is removing these 

recommendations from the regulatory 

text because (1) they were not expressed 

as, or intended to be, regulatory 

requirements, and (2) certifying 

authorities and project proponents are 

best suited to determine the optimal 

pre-filing meeting process on a projectby-project, project type, or general basis. 

EPA also requested comment on 

whether it should specify that all 

certifying authorities should respond 

with written acknowledgement and 

determination of the need for a prefiling meeting and timeline within five 

days of receipt of the pre-filing meeting 

request. Many commenters suggested 

that certifying authorities should be 

required to provide a written response 

within five days informing the project 

proponent if a pre-filing meeting is 

needed. 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 § 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 prefiling meeting will be waived or when 

(if less than 30 days) the project 

proponent may submit the certification 

request. 

EPA requested comment on whether 

project proponents should have the 

opportunity to participate in 

determining the need for a pre-filing 

meeting request. Some commenters 

argued that the project proponent 

should be involved in determining the 

need for a pre-filing meeting. 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. 

3. Implementation 

Pre-filing meeting requests ensure that 

certifying authorities can receive early 

notification of requests for certification 

and discuss the project and potential 


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42Under final rule § 121.5(b)(7), a project 

proponent must submit documentation that a prefiling meeting was requested, unless the pre-filing 

meeting request requirement was waived. See 

section IV.C in this preamble for further discussion 

on the contents of a request for certification when 

EPA is acting as the certifying authority. 

information needs with the project 

proponent before the statutory 

‘‘reasonable period of time’’ for 

certification review begins (e.g., they 

allow the certifying authority to collect 

important details about a proposed 

project and its potential effects on water 

quality). The intent of the pre-filing 

meeting request provision is to support 

early engagement and coordination 

between certifying authorities and 

project proponents as needed. However, 

EPA recognizes that there are various 

project types and complexities. 

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 

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). 

Additionally, the final rule allows 

certifying authorities to determine 

appropriate submission procedures for 

pre-filing meeting requests. When EPA 

acts as the certifying authority, EPA 

would generally find the following 

submission procedures to be 

appropriate. First, EPA recommends 

that project proponents submit a prefiling meeting request to the Agency in 

writing.42 Second, the Agency 

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, 

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. 

These are good practices for any prefiling meeting requests to any certifying 

authority. 

The final rule allows certifying 

authorities flexibility to determine the 

procedures and content of pre-filing 

meetings. EPA, however, 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 prefiling 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 prefiling meeting request requirements are 

fulfilled by any pre-application 

meetings or application submissions to 

the Federal licensing or permitting 

agency. Generally, EPA recommends 

that certifying authorities provide clear 

expectations for pre-filing meetings to 

ensure they are used efficiently and 

effectively. 

C. Request for Certification 

1. What is the Agency finalizing? 

At § 121.5(a), EPA is requiring that all 

requests for certification be in writing, 

signed, and dated and include defined 

minimum contents. Unlike the proposed 

rule, which required a copy of the draft 

Federal license or permit for all requests 

for certification, the Agency is 

bifurcating the minimum content 

requirements for an individual Federal 

license or permit and the issuance of a 

general Federal license or permit. Under 

the final rule, 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 qualityrelated 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. For all 

requests for certification, the final rule 

requires a certifying authority to send 

written confirmation to the project 

proponent and Federal agency of the 

date that a request for certification is 

received by the certifying authority in 

accordance with its applicable 

submission procedures. 

Additionally, the final rule provides 

that where a project proponent is 

seeking certification from EPA when the 

Agency is the certifying authority, or 

from a state or authorized Tribe that 

does not specify additional contents of 

a request for certification (e.g., through 

regulation, forms, etc.), the project 

proponent must also submit seven 

additional components, as applicable, 

including: (1) A description of the 

proposed activity, including the 

purpose of the proposed activity and the 

type(s) of discharge(s) that may result 

from the proposed activity; (2) The 

specific location of any discharge(s) that 

may result from the proposed activity; 

(3) A map or diagram of the proposed 

activity site, including the proposed 

activity boundaries in relation to local 

streets, roads, and highways; (4) A 

description of current activity site 

conditions, including but not limited to 

relevant site data, photographs that 

represent current site conditions, or 

other relevant documentation; (5) The 

date(s) on which the proposed activity 

is planned to begin and end and, if 

known, the approximate date(s) when 

any discharge(s) may commence; (6) A 

list of all other Federal, interstate, 

Tribal, state, territorial, or local agency 

authorizations required for the proposed 

activity and the current status of each 

authorization; and (7) Documentation 

that a pre-filing meeting request was 

submitted to the certifying authority in 

accordance with applicable submission 

procedures, unless the pre-filing 


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meeting request requirement was 

waived. 40 CFR 121.5(b). 

The Agency is also finalizing the 

ability for state or Tribal 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, in lieu of 

relying on EPA’s default list of 

additional contents. Therefore, under 

this final rule, where a project 

proponent is requesting certification 

from a certifying authority other than 

EPA and that certifying authority has 

identified additional required contents 

of a request for certification beyond the 

minimum contents outlined in 40 CFR 

121.5(a), then the request for 

certification must include those 

additional required contents. 

The Agency restructured § 121.5 to 

clarify which components are required 

for all requests for certification versus 

which components depend on the 

certifying authority. Section 121.5(a) 

defines the minimal contents for all 

requests for certification, no matter the 

certifying authority (i.e., states, Tribes, 

or EPA). Section 121.5(b) defines the 

additional contents in a request for 

certification when EPA is 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. Lastly, 

§ 121.5(d) clarifies that if the certifying 

authority is a state or authorized Tribe 

that has not identified additional 

contents for a request for certification, 

then the project proponent must include 

those additional contents defined at 

§ 121.5(b) in a request for certification. 

This structural change is intended to 

provide greater clarity for stakeholders 

in implementation of this final rule. 

2. Summary of Final Rule Rationale and 

Public Comment 

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.’’) (emphasis 

added). The statute does not define 

either ‘‘request for certification’’ or 

‘‘receipt.’’ 

In the 2020 Rule, the Agency defined 

‘‘certification request’’ for all certifying 

authorities and asserted that ambiguities 

in the statutory language had led to 

inefficiencies in the certification 

process. 40 CFR 121.5 (2020); see 85 FR 

42243 (July 13, 2020). In particular, the 

2020 Rule preamble provided that states 

and authorized Tribes could not rely on 

state or tribally defined ‘‘complete 

applications’’ to start the certification 

process, but rather must rely on a 

certification request as defined in EPA’s 

regulation to initiate the process. The 

Agency relied on New York State 

Department of Environmental 

Conservation v. FERC, in which the 

Court of Appeals for the Second Circuit 

rejected New York’s argument that the 

section 401 process ‘‘begins only once 

[the state agency] deems an application 

‘complete’ ’’ and, instead, agreed with 

FERC that the section 401 review 

process begins when the state receives 

a request for certification. 884 F.3d 450, 

455 (2d Cir. 2018) (‘‘NYSDEC’’). The 

court found that ‘‘[t]he plain language of 

Section 401 outlines a bright-line rule 

regarding the beginning of review’’ and 

reasoned that ‘‘[i]f the statute required 

‘complete’ applications, states could 

blur this bright-line rule into a 

subjective standard, dictating that 

applications are ‘complete’ only when 

state agencies decide they have all the 

information they need.’’ Id. at 455–56. 

Some commenters asserted that the 

2020 Rule’s approach provided clarity 

about the requirements for project 

proponents to request certification and 

when the reasonable period of time 

begins. These commenters stated that 

the 2020 Rule created a predictable and 

transparent certification process by 

defining a clear list of contents of 

certification requests. Conversely, some 

commenters highlighted challenges with 

implementing the 2020 Rule’s approach 

for certification requests. Commenters 

stated that 2020 Rule requirements were 

disconnected from longstanding 

cooperative processes established 

among stakeholders and created 

confusion due to differences from 

certifying authorities’ requirements. 

EPA agrees 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 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. 

EPA is also finalizing conforming 

changes to the part 124 regulations 

governing the contents of a request for 

certification of EPA-issued NPDES 

permits. EPA proposed to delete 

§ 124.53(b) because the provision 

allowed a request for certification to 

precede development of a draft NPDES 

permit, which was inconsistent with the 

proposed rule. EPA also proposed to 

delete § 124.53(c) because the list of 

contents at § 124.53(c) differed from the 

proposed list of contents. See 87 FR 

35336–57 (June 9, 2022). In light of 

changes in the final rule, EPA is not 

deleting in full § 124.53(b) or (c), and 

instead is making targeted revisions to 

be consistent with the final rule. First, 

EPA is revising 40 CFR 124.53(b), which 

provided that when EPA received a 

permit application without certification, 

EPA shall forward the application to the 

certifying authority with a request that 

certification be granted or denied. EPA 

is revising § 124.53(b) to clarify that 

EPA may forward permit applications 

for individual NPDES permits to a 

certifying authority and request 

certification consistent with final rule 

§§ 121.4 and 121.5 (e.g., EPA will 

request a pre-filing meeting and include 

contents for a request for certification 

consistent with this final rule). It is 

worth noting that although § 124.53(b) 

allows EPA to request certification on a 

permit application for individual 

permits (consistent with this final rule), 

this approach is not common practice. 

Under the final rule and § 124.53(c), 

EPA may continue to request 

certification after the draft individual or 

general NPDES permit is prepared (and 

include a copy of draft permit in the 

request for certification). Nevertheless, 

EPA is retaining § 124.53(b) with the 

revisions discussed above to provide 

stakeholders and EPA with flexibility to 

request certification prior to developing 

a draft individual NPDES permit. 

Second, EPA is also revising 40 CFR 

124.53(c), which identified the required 

contents of a request for certification of 

an EPA-issued NPDES permit if a 

certification had not been received by 

the time the draft permit is prepared. 


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43For example, this could 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. 

44These examples are not intended to be 

exhaustive, nor does EPA expect that all of the 

example materials listed will be readily available 

and/or materials that informed the develop of the 

application or draft Federal license or permit in all 

cases. Rather, EPA is providing these examples 

because these are materials that EPA has previously 

asked for and found informative when conducting 

its reviews of requests for certification. 

EPA is revising § 124.53(c) to specify 

that if certification has not been 

requested by the time a draft NPDES 

permit is prepared, EPA will send a 

request for certification consistent with 

final rule § 121.5, and will include a 

copy of the draft permit with that 

request. EPA is finalizing deletions of 

the required contents of a request for 

certification in § 124.53(c)(2) and (3) 

because the list of contents at 

§ 124.53(c)(2) and (3) differ from the list 

of contents in § 121.5. Also, as 

explained in section IV.D in this 

preamble, the statement required at 

§ 124.53(c)(3) regarding the reasonable 

period of time was not consistent with 

the approach to the reasonable period of 

time at § 121.6. 

The following sections discuss the 

minimum contents for all requests for 

certification, state and Tribal authority 

to define additional contents, the 

additional contents defined by EPA and 

their application in instances where 

states and Tribes decline to define such 

additional contents, and when a 

certifying authority is in ‘‘receipt’’ of a 

request for certification. 

a. Minimum Contents of a Request for 

Certification 

i. Application or Draft Federal License 

or Permit 

In a change from the proposed rule, 

EPA is finalizing that all requests for 

certification on an individual Federal 

license or permit shall include ‘‘[a] copy 

of the Federal license or permit 

application submitted to the Federal 

agency,’’ while all requests for 

certification on the issuance of a general 

Federal license or permit shall include 

‘‘[a] copy of the draft Federal license or 

permit.’’ 40 CFR 121.5(a). EPA proposed 

in § 121.5(a) that all requests for 

certification ‘‘shall include a copy of the 

draft license or permit’’ to ensure that 

states and Tribes have the critical 

information to make a timely and 

informed certification decision. 87 FR 

35332. Many commenters opposed this 

approach 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. 

In response to 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). 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. 

ii. Water Quality-Related Materials 

In the final rule, EPA is requiring 

project proponents to include ‘‘any 

readily available water quality-related 

materials that informed the 

development of the application’’ for 

requests for certification for individual 

Federal licenses or permits. See 40 CFR 

121.5(a)(1)(ii). In the case that the 

request for certification is for the 

issuance of a general Federal license or 

permit, it must include ‘‘any readily 

available water quality-related materials 

that informed the development of the 

draft Federal license or permit.’’ See 40 

CFR 121.5(a)(2)(ii). The term ‘‘readily 

available water quality-related materials 

that informed the development of’’ 

either the application or the draft 

license or permit refers to existing water 

quality-related materials that are in the 

project proponent’s possession or easily 

obtainable 43 and informed the project 

proponent’s development of the 

application or draft license or permit. 

These materials for either request may 

include, but are not limited to, water 

quality baseline conditions from the 

project site, sediment and erosion 

control plans, restoration plans, 

alternatives analyses, mitigation plans, 

modeling, and/or other materials that 

have already been developed for the 

Federal license or permit application or 

draft license or permit and would help 

inform the certifying authority of the 

water quality-related impacts from the 

activity.44

The Agency had proposed that, at a 

minimum, all requests for certification 

include ‘‘any existing and readily 

available data or information related to 

potential water quality impacts from the 

proposed project.’’ 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 

Environmental Assessment (EA) or 

other water quality monitoring data, 

would reduce the need for duplicative 

studies and analyses. 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,’’ and a few commenters noted 

that this information is important for 

decision-making and allows certifying 

authorities to better evaluate potential 

impacts of a project. Conversely, many 

commenters did not support the 

inclusion of ‘‘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. Some of these commenters 

added that the requirement would 

create confusion and delays in the 

certification process. 

In response to commenter concerns, 

EPA is adjusting the regulatory text in 

the final rule to read ‘‘any readily 

available water quality-related materials 

that informed the development of’’ the 

application or draft general Federal 

license or permit. See 40 CFR 

121.5(a)(1)(ii), (a)(2)(ii). EPA 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 

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 


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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 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. 

A few commenters asserted that while 

they supported the minimum 

requirements of the proposed rule, they 

believed that 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. EPA 

appreciates these concerns, however, as 

discussed above, the Agency finds it 

reasonable and appropriate for the rule 

to balance certifying authority 

information needs with legitimate 

implementation concerns by limiting 

the default requirements to existing, 

readily available information. However, 

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 may also 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. 

b. Additional Contents in a Request for 

Certification 

Consistent with the proposed rule, 

EPA is finalizing that where a 

‘‘certifying authority has identified 

contents of a request for certification’’ 

that are relevant to the water qualityrelated impacts from the activity, in 

addition to the minimum requirements 

discussed above, ‘‘the project proponent 

shall include in the request for 

certification those additional contents 

identified prior to when the request for 

certification is made.’’ 40 CFR 121.5(c). 

The Agency is also finalizing a set of 

additional contents that a project 

proponent must include in a request for 

certification when EPA acts as the 

certifying authority. 40 CFR 121.5(b). 

For further clarity, the additional 

contents listed at § 121.5(b) are required 

in each request for certification to a state 

or authorized Tribe that has not 

established its own list of requirements. 

If a state or authorized Tribe has 

established its own list for a request for 

certification, then EPA’s list of 

additional contents would not apply. 

The Agency has restructured § 121.5 to 

clearly distinguish between 

requirements that apply to all requests 

for certification, see § 121.5(a), versus 

requirements that only apply to requests 

for certification to EPA or states or 

Tribes that fail to define additional 

contents, see § 121.5(b) and (d), or 

requirements that apply to requests for 

certification to states or Tribes that 

define additional contents, see 

§ 121.5(c). 

EPA acknowledges that this final 

rule’s approach contrasts with the 

approach taken in the 2020 Rule, which 

defined the contents of a certification 

request for all certifying authorities. 

However, this final rule is a better—and 

more flexible—approach to defining the 

term ‘‘request’’ and consistent with 

NYSDEC. That decision holds that the 

reasonable period of time begins after 

receipt of a request for certification and 

not when a state deems it ‘‘complete;’’ 

it does not preclude EPA or other 

certifying authorities from defining—in 

advance—those contents a certification 

request must contain. As discussed 

below, this approach is consistent with 

stakeholder input and the cooperative 

federalism principles central to section 

401 and the CWA. 

i. State and Tribal Certifying Authorities 

Under § 121.5(c), ‘‘[w]here a project 

proponent is seeking certification from 

a certifying authority other than the 

Regional Administrator, and that 

certifying authority has identified 

contents of a request for certification in 

addition to those identified in paragraph 

(a) of [§ 121.5], the project proponent 

shall include in the request for 

certification those additional contents 

identified prior to when the request for 

certification is made.’’ This approach is 

consistent with the proposal and 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. 

Many commenters supported 

certifying authorities having the ability 

to define the contents of a request for 

certification, saying that it ensures states 

and Tribes have the information they 

need to protect their water quality. 

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 comply with their water 

quality requirements. Several 

commenters argued that this approach is 

an improvement over the 2020 Rule’s 

‘‘one-size fits all’’ approach to request 

for certification. EPA agrees that 

certifying authorities are best suited for 

determining their needs in making their 

certification decisions. 

As an initial matter, 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’s 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. 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 


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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. 

Some commenters opposed the 

proposed rule and argued that the 

Agency cannot delegate the ability to 

define additional requirements for a 

certification request to certifying 

authorities under NYSDEC. The Agency 

does not agree. 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 define the 

term ‘‘request for certification,’’ EPA 

and other certifying authorities may 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. No court has considered 

this issue 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. 

Most commenters that opposed this 

approach argued that, as an 

implementation matter, EPA is inviting 

certifying authorities to engage in the 

types of practices that were rejected by 

the Second Circuit in NYSDEC. 

Specifically, commenters asserted that 

the proposed approach would allow 

certifying authorities to issue 

regulations that expand the required 

contents of a request for certification 

without any oversight or limits and for 

reasons other than potential water 

quality impacts. Other commenters 

asserted that the proposed approach did 

not enforce any transparency 

requirements against certifying 

authorities, and, therefore, 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. Still other 

commenters argued that the ability of 

states and authorized Tribes to define 

the contents for a request for 

certification would result in a 

patchwork of different requirements, 

placing burdens on project proponents, 

especially for projects that span 

multiple states. The Agency 

acknowledges these concerns and has 

incorporated reasonable changes into 

the final rule that establish 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, as identified in § 121.3, the 

scope of the certifying authority’s 

review is explicitly limited in the final 

rule to ‘‘the water quality-related 

impacts.’’ To clarify that such 

limitations extend to the contents of a 

request for certification, EPA added text 

at § 121.5(c) that such additional 

contents are ‘‘relevant to the water 

quality-related impacts from the 

activity.’’ Hence, contents of requests for 

certification that are substantively 

beyond the scope of water qualityrelated impacts cannot be reasonably 

necessary to make an informed decision 

regarding the potential water qualityrelated impacts from the activity, and 

thus would not be in conformity with 

the regulation. The regulatory text 

provides flexibility within the scope for 

certifying authorities interested in 

developing their own additional 

contents of requests for certification. 

Next, § 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 before 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. 

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 nonexhaustive or vague lists that a 

certifying authority could rely on to 

continually deem requests incomplete. 

When developing their lists of 

additional contents in a request for 

certification, EPA recommends that 

certifying states and authorized Tribes 

look to § 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. 

The Agency originally proposed that 

the contents of a request for certification 

be established by a state or authorized 

Tribe in regulation. Several commenters 

disagreed that certifying authorities 

should be limited to defining the 

contents of a request for certification in 

regulation. A few commenters asserted 

that the contents do 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 

would be an unnecessary burden, time 

consuming (e.g., may require legislative 

approval before going into effect), and 

interfere with a state’s ability to describe 

the information in certification request. 

Conversely, 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, and 

the public would be fully informed of 

when the reasonable time begins and 

ends. One 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. 


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45The use of ‘‘complete’’ applications is also 

applied in other Federal environmental realms (e.g., 

the Safe Drinking Water Act, the Clean Air Act). 

See, e.g., 40 CFR 144.31, 40 CFR 51.103, appendix 

V to part 51. 

46EPA 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). 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. 

After considering public comments, 

the Agency is not requiring a state or 

authorized Tribe to define additional 

contents of a request for certification in 

regulation. The Agency agrees that the 

required contents of a request do not 

need to be 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 authorized 

Tribes use different approaches to 

define the required contents of a request 

for certification, including statute, 

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 legislative 

approval before going into effect), and 

may interfere with certifying authorities’ 

ability to describe the information they 

expect in a request for certification. 

The final rule approach also addresses 

project proponent concerns about 

certifying authorities that, in the past, 

may have unexpectedly required 

additional information from the project 

proponent to satisfy the request for 

certification requirement before starting 

the clock on the ‘‘reasonable period of 

time.’’ Under the approach EPA is 

finalizing, the reasonable period of time 

starts on the date that a ‘‘request for 

certification’’ was received in 

accordance with the certifying 

authority’s applicable submission 

procedures. As discussed above, the 

request for certification is defined to 

mean a request that contains the 

contents required by EPA’s final 

regulations and any additional state or 

Tribal requirements identified prior to 

when the request for certification was 

made. This approach creates a brightline for project proponents seeking to 

avoid unexpected shifts and identify the 

necessary contents for a request for 

certification with certainty. 

In 1971, the Agency opted to not 

define what information, if any, was 

sufficient to start the review process for 

all certifying authorities and instead 

opted to define the information only for 

EPA when it acts as the certifying 

authority. 40 CFR 121.22 (2019). As a 

result, over the last approximately 50 

years, many states and authorized 

Tribes established their own 

requirements for what constitutes a 

request for certification, also called a 

‘‘certification request,’’ typically 

defining it as a so-called ‘‘complete 

application.’’ See, e.g., Cal. Code Regs. 

Tit. 23, sec. 3835; La. Admin. Code tit. 

33, sec. IX–1507; Ohio Admin. Code 

3745–32–03. Prior Agency guidance 

acknowledged this practice. See 1989 

Guidance, at 31 (April 1989) (‘‘Thus, 

after taking the federal agencies’ 

regulations into account, the State’s 401 

certification regulations should link the 

timing for review to what is considered 

receipt of a complete application.’’); see 

also 2010 Handbook at 15–16 (rescinded 

in 2019, see supra) (‘‘States and tribes 

often establish their own specific 

requirements for a complete application 

for water quality certification. . . . The 

advantage of a clear description of 

components of a complete [section] 401 

certification application is that 

applicants know what they must be 

prepared to provide, and applicant and 

agencies alike understand when the 

review timeframe has begun.’’). 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.’’ 

The use of a ‘‘completeness’’ standard 

for applications or similar documents is 

not a novel concept in CWA 

implementing regulations.45 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 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.’’ 

While acknowledging the ruling in 

NYSDEC, the Agency also notes 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. 

States’ and authorized Tribes’ 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. The limitations 

referenced above do 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. 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. 

ii. Requirements When EPA Is the 

Certifying Authority 

The Agency is finalizing a list of 

additional contents required for requests 

for certification submitted to EPA when 

EPA acts as a certifying authority.46 This 

list also applies to requests for 

certification submitted to states and 

authorized Tribes that have not 

identified additional contents of a 

request for certification. As discussed 

below, these components contain some 

similarities to the 1971 Rule and 2020 


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Rule, with revisions to provide further 

clarification and efficiency for project 

proponents, EPA when it acts as a 

certifying authority, and when a state or 

authorized Tribe has not established its 

own definition of ‘‘request for 

certification.’’ 

EPA proposed a list of contents that 

shall be included in requests for 

certification to the Regional 

Administrator shall include the 

following, if not already included in the 

draft license or permit: 

1. The name and address of the 

project proponent; 

2. The project proponent’s contact 

information; 

3. Identification of the applicable 

Federal license or permit, including 

Federal license or permit type, project 

name, project identification number, 

and a point of contact for the Federal 

agency; 

4. Where available, 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; and 

5. Documentation that a pre-filing 

meeting request was submitted to the 

certifying authority in accordance with 

applicable submission requirements, 

unless a pre-filing meeting request has 

been waived. 40 CFR 121.5(c) 

Proposed § 121.5(b) also provided that 

‘‘[w]here a project proponent is seeking 

certification from a certifying authority 

other than the Regional Administrator, 

and that certifying authority has not 

identified in regulation additional 

contents of a request for certification, 

the project proponent shall submit a 

request for certification as defined in 

[§ 121.5(c)].’’ 

In this final rule at § 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: 

1. A description of the proposed 

activity, including the purpose of the 

proposed activity and the type(s) of 

discharge(s) that may result from the 

proposed activity; 

2. The specific location of any 

discharge(s) that may result from the 

proposed activity; 

3. A map or diagram of the proposed 

activity site, including the proposed 

activity boundaries in relation to local 

streets, roads, and highways; 

4. A description of current activity 

site conditions, including but not 

limited to relevant site data, 

photographs that represent current site 

conditions, or other relevant 

documentation; 

5. The date(s) on which the proposed 

activity is planned to begin and end 

and, if known, the approximate date(s) 

when any discharge(s) may commence; 

6. A list of all other Federal, 

interstate, Tribal, state, territorial, or 

local agency authorizations required for 

the proposed activity and the current 

status of each authorization; and 

7. Documentation that a pre-filing 

meeting request was submitted to the 

certifying authority in accordance with 

applicable submission procedures, 

unless the pre-filing meeting request 

requirement was waived. 

A few commenters agreed that EPA’s 

additional contents for a request for 

certification should be the default 

contents for a request to a certifying 

authority that does not define additional 

contents. However, some commenters 

expressed concern that EPA’s default 

list of additional certification request 

components was inadequate and did not 

capture all the items a state or 

authorized Tribe may need for its 

analysis. One commenter asserted that 

EPA’s default additional components 

create a presumption that EPA’s list is 

sufficient for a request for certification, 

and recommended that EPA make clear 

that states and authorized Tribes have 

the authority to specify the contents of 

a request for certification where they are 

the certifying authority. 

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 

request for certification to submit the 

additional contents identified at 

§ 121.5(b). See § 121.5(d). However, this 

final rule does not create the 

presumption that the contents identified 

at § 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 above, the additional contents 

in § 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 § 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. 

EPA requested comment on an 

alternative list of additional contents to 

accompany a request for certification on 

a Federal license or permit application. 

Under this alternative approach, the 

project proponent would be required to 

submit ‘‘proposed activity information’’ 

with six components, including the 

following: 

1. A description of the proposed 

activity, including the purpose of the 

proposed activity and the type(s) of 

discharge(s) that may result from the 

proposed activity; 

2. The specific location of any 

discharge(s) that may result from the 

proposed activity; 

3. A map and/or diagram of the 

proposed activity site, including the 

proposed activity boundaries in relation 

to local streets, roads, highways; 

4. A description of current activity 

site conditions, including but not 

limited to relevant site data, 

photographs that represent current site 

conditions, or other relevant 

documentation; 

5. The date(s) on which the proposed 

activity is planned to begin and end 

and, if known, the approximate date(s) 

on which any discharge(s) will take 

place; and 

6. Any additional information to 

inform whether any discharge from the 

proposed activity will comply with 

applicable water quality requirements. 

87 FR 35336. 

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. On the other 

hand, some commenters provided 

suggestions for the default additional 

contents. A few commenters 

recommended supplementing the 

default additional request components 

with the six additional components 

listed in the proposal preamble as an 

alternative, and as suggested by one of 

these commenters, revising as 

appropriate to address any duplication. 

EPA does not agree with commenters 

asserting that additional components are 

unreasonable. While some commenters 

said doing so was unnecessary, the 

relevant inquiry is whether EPA’s 


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inclusion of additional components is 

‘‘reasonable,’’ not whether it is 

‘‘necessary.’’ EPA anticipates that the 

list of additional required contents at 

§ 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 § 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 § 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. 

EPA agrees with commenters who 

suggested that the Agency combine the 

proposed and alternative lists of 

additional contents. As discussed 

below, the Agency has revised the list 

of additional contents to reduce 

duplication among the minimal 

contents of a request for certification. 

Additionally, the Agency recognizes 

that some of the components listed at 

§ 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 § 121.5(b) to clarify 

that only the applicable additional 

components need to be included in a 

request for certification to EPA. 

First, based on commenter 

recommendations, EPA is not finalizing 

the components of the proposed list that 

are expected to be captured by the 

requirements in § 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. 

Second, 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, Tribal, or local authorizations and 

potentially reduce redundancies or 

inconsistencies 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 project applicants in the future. 

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. 

Third, like the 2020 Rule, the Agency 

is finalizing a requirement that the 

project proponent submit 

documentation that it requested a prefiling meeting, unless the pre-filing 

meeting request has been waived. The 

documentation should be in writing, 

such as a copy of the email requesting 

the pre-filing meeting. As discussed in 

section IV.B in this preamble, a 

certifying authority may waive the 

requirement for a pre-filing meeting 

request. In that event, the project 

proponent would not need to produce 

documentation of a pre-filing meeting 

request. 

Fourth, the Agency is adding five 

components that were offered as 

alternatives to the final rule text to 

provide EPA with information about the 

proposed activity, including a 

description of the proposed activity, the 

location of any discharge from the 

proposed activity, a map or diagram of 

the proposed activity site, a description 

of current activity site conditions, and 

the date(s) on which the proposed 

activity will begin and end. These 

components are similar to those in the 

2020 Rule, see § 121.5(b)(4) (2020), and 

the 1971 Rule, see § 122.22(b), (d) 

(2019). These components are necessary 

to initiate EPA’s analysis of a request for 

certification on a Federal license or 

permit application. 

The Agency is not including the sixth 

alternative component offered at 

proposal, which would have required a 

project proponent to submit any 

additional information to inform 

whether any discharge from the 

proposed activity will comply with 

applicable water quality requirements. 

EPA finds that such a component would 

be too vague and would not provide 

project proponents with a clear, 

predictable set of a requirements for a 

request for certification. However, if 

EPA later determines additional 

information would be helpful to inform 

its decision-making on a request for 

certification, this final rule does not 

preclude EPA from asking for additional 

information after a certification request 

is submitted. But EPA cannot require 

additional components, aside from 

contents listed at § 121.5(a) and (b), in 

a request for certification. 

The Agency is also finalizing the 

removal of the contents of the 2020 Rule 

at § 121.5(b)(5), (8), and (9); the 1971 

Rule also contained similar contents to 

§ 121.5(b)(5) of the 2020 Rule. See 40 

CFR 121.22(c), (e) (2019). Section 

121.5(b)(5) of the 2020 Rule, which 

required the project proponent to 

‘‘[i]nclude 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,’’ is unnecessary 

since the final rule requires a project 

proponent to provide the Federal 

license or permit application or draft 

Federal license or permit, as 

appropriate, and any readily available 

water quality-related materials that 

informed the development of the 

application or draft Federal license or 

permit in its request. The Agency also 

finds it unnecessary to retain the 

requirements at § 121.5(b)(8) and (9) of 

the 2020 Rule. In 2020, EPA required 

the project proponent to include an 

attestation statement that the project 

proponent ‘‘certifies that all information 

contained herein is true, accurate, and 

complete to the best of my knowledge 

and belief’’ at § 121.5(b)(8) ‘‘to create 

additional accountability on the part of 

the project proponent to ensure that 

information submitted in a certification 

request accurately reflects the proposed 

project.’’ 85 FR 42245. EPA is unaware 

of any issues or concerns that project 

proponents will not provide accurate 

information in the request for 

certification without such attestation. 

Furthermore, the final contents for a 

request for certification include either 

the license or permit application or a 

copy of the draft Federal license or 

permit, which presumably incorporates 

accurate information about the proposed 

project. Additionally, § 121.5(b)(9) of 

the 2020 Rule, which required the 

project proponent to include a statement 

that it ‘‘hereby requests that the 

certifying authority review and take 

action on this CWA 401 certification 

request within the applicable reasonable 

period of time,’’ is unnecessary because 

a project proponent is required to 

submit a request for certification as 

defined in this final rule. Submitting a 

request for certification as defined in 

this final rule should be a clear 


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indication to the certifying authority 

that the project proponent is seeking 

certification. 

A few commenters provided detailed, 

lengthy lists of additional contents, 

beside the seven that EPA is finalizing, 

that could be required 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. 

EPA appreciates commenter 

suggestions and while EPA is not 

including additional contents in 

§ 121.5(b), aside from those discussed 

above, the Agency emphasizes that 

certifying authorities are free to define 

additional contents for their requests for 

certification. As discussed in the prior 

subsection, 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. 

c. Defining ‘‘Receipt’’ of a Request for 

Certification 

The Agency is clarifying at § 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 § 121.5, in 

accordance with the certifying 

authority’s applicable submission 

procedures.’’ In proposed § 121.6(a), 

EPA stated that ‘‘the reasonable period 

of time shall begin upon receipt of a 

request for certification.’’ The Agency 

proposed to define ‘‘receipt’’ at 

§ 121.1(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 § 121.6(a). 

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 1971 Rule did 

not address or define the term ‘‘receipt,’’ 

however, the Agency opted to define the 

term in the 2020 Rule. 40 CFR 121.1(m) 

(2020). The 2020 Rule defined the term 

‘‘receipt’’ as ‘‘the date that a certification 

request is documented as received by a 

certifying authority in accordance with 

applicable submission procedures.’’ Id. 

In implementation of the 2020 Rule, 

there was some confusion regarding 

whether it was the Federal agency’s or 

certifying authority’s responsibility to 

determine that a certification request, as 

defined by the 2020 Rule, was received. 

Consistent with the statutory text, the 

reasonable period of time begins on the 

date that the certifying authority 

receives a request for certification, as 

defined at § 121.5, and is submitted in 

accordance with the certifying 

authority’s applicable submission 

procedures. 40 CFR 121.6(a). As 

discussed in more detail below, the 

certifying authority must send written 

notification to the project proponent 

and Federal agency of the date the 

request for certification was received. 

Some commenters asserted that, due 

to the wide variety of project types, the 

regulations should not dictate when the 

reasonable period of time begins. These 

commenters added that states and 

authorized Tribes should determine 

when the reasonable period of time 

starts, and when they have sufficient 

information to conduct a proper review, 

provided it does not exceed the 

statutory one-year limit. As described 

above, EPA provides in the final rule at 

§ 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 § 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. 

Some commenters stated that the 

proposed definition of ‘‘receipt’’ would 

limit predictability and could allow 

certifying authorities to delay the 

certification process by saying they have 

not received the request for certification 

in full and in accordance with its 

submission procedures. 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. While not retaining 

a definition of ‘‘receipt’’ in the final 

rule, EPA maintains that 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 § 121.5 of the 

final rule, in accordance with the 

certifying authority’s applicable 

submission procedures. See 40 CFR 

121.6(a). 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. 

Similarly, the Agency disagrees that the 

concept of ‘‘completeness’’ is inherently 

subjective. As discussed above, 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. See 

discussion supra. 

The project proponent must submit 

the request for certification in 

accordance with the certifying 

authority’s applicable submission 

procedures. 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 


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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. 

As mentioned above, 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 § 121.5(d). 

However, the Agency has moved this 

provision to § 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 section 401(a)(1), it 

begins on the date that the project 

proponent submitted the 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 § 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. 

3. Implementation 

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. Because the 

final rule allows certifying authorities to 

require additional contents in a request 

for certification as long as they are 

identified prior to when the request for 

certification is made, certifying 

authorities should make their additional 

contents for request for certification and 

applicable submission procedures 

readily available and transparent to the 

regulated public. EPA 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. 

Another way a certifying authority 

may further support the efficient review 

of requests for certification would be for 

the certifying authority to make 

available draft certification conditions 

that project proponents can consider 

while developing their project design 

plans and request for certification 

materials. Project proponents can save 

time and money by preparing for and 

mitigating the impacts from an activity 

that will not comply with applicable 

water quality requirements. EPA 

acknowledges that not all certifying 

authorities will be able to provide 

conditions that anticipate potential 

water quality impacts from various 

types of activities that will not comply 

with their applicable water quality 

requirements; however, some certifying 

authorities have made example 

certification conditions for certain 

project types or waterbodies available 

prior to receipt of requests for 

certification for those project types or 

geographic areas. 

The Agency wishes to clarify several 

implementation questions or issues 

related to the request for certification 

that have previously arisen or were 

revealed through public comment on 

this rulemaking. First, with regards to 

project proponents seeking projectspecific certification to obtain 

authorization under a Corps general 

permit, project proponents must submit 

the minimum contents defined at 

§ 121.5(a)(1). For example, if a state or 

authorized 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 

authorized Tribe. In those cases, the 

‘‘application’’ part of the request for 

certification may take the form of a preconstruction notification (PCN), along 

with any readily available water qualityrelated materials that informed the 

development of the application (e.g., the 

general permit). Second, regarding 

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 to 

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 for 50 years under 

the 1971 Rule. 

A few commenters also raised various 

implementation-related questions with 

the proposed inclusion of the draft 

Federal license or permit in all requests 

for certification. 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 (e.g., license 

or permit is ready for issuance, final 

draft license or permit). Commenters 

also questioned what would occur if the 

project changed after receiving a draft 

Federal license or permit, as well as 

whether the project proponent was best 

suited to provide the certifying 

authority with a copy of the draft 

Federal license or permit. 

As discussed above, in this final rule, 

a draft Federal license or permit is only 

required for requests for certification on 

the issuance of general Federal licenses 

or permits. Currently, the Agency is 

only aware of general permits for two 

Federal agencies: the Corps (section 404 

program) and EPA (section 402 

program). 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 the process of requesting 

certification on these Federal licenses or 

permits and Federal agencies will be 

acting as the ‘‘project proponent’’ in 


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47A 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. 

48EPA 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. 

these instances. 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 

nationwide permits (NWPs) when they 

are renewed every five years. First, the 

Corps proposes the draft NWPs and 

takes comment on the proposals, 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 proposals 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 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, there 

may always be a degree of uncertainty 

or possibility for project changes when 

it comes to certifying any project 

because a Federal agency must obtain a 

certification prior to issuing a Federal 

license or permit.47 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. See section IV.F in this 

preamble for further discussion on 

adaptive management conditions. 

Neither the CWA nor this final rule 

require project proponents to submit the 

request for certification for an 

individual license or permit at the time 

a Federal license or permit application 

is submitted. Accordingly, project 

proponents would not be precluded 

from providing a copy of the draft 

Federal license or permit, in addition to 

the Federal license or permit 

application, when requesting 

certification for individual Federal 

licenses or permits. For example, EPA 

can continue its longstanding practice of 

submitting a copy of the draft individual 

CWA section 402 NPDES permit to the 

certifying authority for its review. 

However, project proponents would not 

be required to wait to request 

certification for an individual Federal 

license or permit until a copy of the 

draft Federal license or permit is 

obtained, unless the certifying authority 

has defined in its additional contents for 

a request for certification that the 

request must include a copy of the draft 

Federal license or permit. 

A few commenters recommended 

allowing certifying authorities to issue 

certification decisions in the absence of 

a request for certification. 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 this 

preamble for further discussion on 

when certification is required.48

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 this 

preamble regarding the Agency’s 

position on the legality of the practice 

of withdrawing and resubmitting 

requests for certification. 

As mentioned above, 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. 40 CFR 

121.6(a). If a project proponent submits 

a request for certification that does not 

meet the requirements of § 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 § 121.5 of this final 

rule. However, as discussed previously, 

certifying authorities and project 

proponents can avoid such outcomes by 

leveraging early engagement 

opportunities (i.e., pre-filing meetings) 

to ensure a common understanding of 

the required contents of a request for 

certification. 

D. Reasonable Period of Time 

1. What is the Agency finalizing? 

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 U.S.C. 

1341(a)(1). At § 121.6(a), EPA clarifies 

that the reasonable period of time begins 

on the date that a request for 

certification, as discussed in the 

previous section, is received by the 

certifying authority in accordance with 

its applicable submission procedures. 

Section 121.6(b) provides Federal 

agencies and certifying authorities with 

the ability to jointly set the reasonable 

period of time, provided it does not 

exceed one year from the date that the 

request for certification was received. 

The final rule clarifies that the joint 

determination of the reasonable period 

of time may happen on a case-by-case 

basis or categorically. See 40 CFR 

121.6(b). 

Under this final rule, if the Federal 

agency and certifying authority do not 

agree upon a reasonable period of time, 

the default reasonable period of time 

will be six months from the date that the 

request for certification was received. 

See 40 CFR 121.6(c). This default 

approach obviates the need for a dispute 

resolution process in the event the 

certifying authority and Federal agency 

are not able to agree on the reasonable 

period of time. The Agency proposed a 

60-day default reasonable period of 

time. However, for several reasons 

discussed below, the Agency is not 

finalizing the proposed 60-day default 

reasonable period of time. 

The pre-filing meeting could be a 

venue for the Federal agency and 

certifying authority to discuss the length 

of the reasonable period of time, 

particularly because the project 

proponent participates in that meeting 

and will, therefore, be informed of any 

reasonable period of time-related 

discussions and decisions. EPA also 

recognizes that the Federal agency and 

the certifying authority may benefit 

from discussing the length of the 

reasonable period of time before the prefiling meeting to then use the pre-filing 

meeting to inform the project proponent 

of the agreed-upon length. 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 


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request for certification, Federal 

agencies and certifying authorities 

might 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. Federal agencies and certifying 

authorities might also elect to establish 

joint reasonable period of time 

procedures and/or agreements through a 

memorandum of agreement (MOA) or 

similar. Such MOAs could apply to all 

federally licensed or permitted activities 

or only to specific types of activities 

(e.g., activities covered by general 

permits). The requests for certification 

that fall under these MOAs would not 

require individual written agreements 

confirming the reasonable period of 

time between the Federal agency and 

certifying authority for each Federal 

license or permit. Alternatively, Federal 

agencies and certifying authorities 

might prefer to agree and establish the 

reasonable period of time in writing on 

a case-by-case basis. 

EPA is finalizing as proposed that 

after the reasonable period of time is set, 

the Federal agency and certifying 

authority may agree to extend the 

reasonable period of time, provided that 

it does not exceed one year from the 

date that the request for certification 

was received. See 40 CFR 121.6(e). 

Section 121.6(d) also provides 

automatic extensions for certain 

situations, as EPA recognizes there are 

circumstances under which the Federal 

agency must extend the reasonable 

period of time without the certifying 

authority needing to negotiate an 

agreement. Such circumstances are 

where a certification decision cannot be 

rendered within the negotiated or 

default reasonable period of time due to 

force majeure events (including, but not 

limited to, government closure or 

natural disasters) and when state or 

Tribal public notice procedures 

necessitate a longer reasonable period of 

time. 

If a longer period of time to review the 

request for certification is necessary due 

to either of these circumstances, upon 

written notification to the Federal 

agency by the certifying authority prior 

to the end of the reasonable period of 

time, the reasonable period of time shall 

be extended by the amount of time 

necessitated by public notice 

procedures or the force majeure event, 

as long as it does not cause the 

reasonable period of time to exceed one 

year from the date that the request for 

certification was received. In its 

notification, the certifying authority 

must provide the Federal agency with a 

written justification for the automatic 

extension. The justification must 

describe the circumstances supporting 

the extension (i.e., accommodating the 

certifying authority’s public notice 

procedures, government closures, or 

natural disasters) and does not require 

Federal agency approval before taking 

effect. The extended reasonable period 

of time would take effect upon 

notification by the certifying authority 

to the Federal agency. 

Aside from these automatic 

extensions, the Agency expects that 

certifying authorities and Federal 

agencies will collaboratively agree to 

discretionary extensions to the 

reasonable period of time where 

appropriate. For example, the certifying 

authority and Federal agency could 

develop, in a MOA or similar 

instrument, a process to identify 

scenarios where changes to the 

reasonable period of time would be 

appropriate. Such scenarios may 

include situations where relevant new 

information becomes available during 

the reasonable period of time. EPA notes 

that the final rule promotes early 

collaboration and pre-filing meetings to 

allow the Federal agency, certifying 

authority, and the project proponent to 

discuss project complexity, seasonal 

limitations, and other factors that may 

influence the amount of time needed to 

complete the certifying authority’s 

analysis. These opportunities may 

reduce the need to extend the jointly 

established or default reasonable period 

of time. 

Consistent with the proposal, EPA is 

not taking a position on the legality of 

withdrawing and resubmitting a request 

for certification. While there may be 

situations where withdrawing and 

resubmitting a request for certification is 

appropriate, drawing a bright regulatory 

line on this issue is challenging, and the 

law in this area is dynamic. See, e.g., 

Hoopa Valley Tribe v. FERC, 913 F.3d 

1099, 1105 (D.C. Cir. 2019) (holding that 

repeated, coordinated withdrawal and 

resubmittal of a certification request 

resulted in a waiver); N.C. Dep’t of 

Envtl. Quality (NCDEQ) v. FERC, 3 F.4th 

655, 676 (4th Cir. 2021) (finding that the 

record did not support FERC’s 

determination that the state and project 

proponent withdrew and resubmitted 

the certification request in a coordinated 

fashion resulting in waiver). For these 

reasons, the final rule does not take a 

position on this issue, instead allowing 

the different state and Tribal certifying 

authorities, Federal agencies, and/or 

possibly project proponents to make 

case-specific decisions addressing the 

practice. 

The Agency is also finalizing 

deletions in the part 124 provisions 

regarding the reasonable period of time 

for certification on EPA-issued NPDES 

permits, formerly located at 40 CFR 

124.53(c)(3), in favor of the reasonable 

period of time provisions in the final 

rule at § 121.6. The approach to the 

reasonable period of time taken in 

§ 124.53(c) was not fully consistent with 

the approach at § 121.6. For instance, 

the standard reasonable period of time 

was 60 days instead of the default six 

months in § 121.6(c). Further, unlike 

§ 121.6(b), § 124.53(c)(3) did not include 

a provision allowing certifying authority 

collaboration in setting the reasonable 

period of time. And unlike § 121.6(d), 

§ 124.53(c)(3) did not allow for 

automatic extensions to accommodate a 

certifying authority’s public notice 

procedures or force majeure events 

(instead allowing extensions beyond the 

default 60 days only if EPA finds 

‘‘unusual circumstances’’ require a 

longer time). Consequently, EPA has 

deleted § 124.53(c)(3). In addition, EPA 

has made conforming changes in 

§ 124.53(c) for consistency with the 

request for certification requirements in 

§ 121.5. 

2. Summary of Final Rule Rationale and 

Public Comment 

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 (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.’’ The 1971 Rule explained 

that a certifying authority would waive 

its opportunity to certify if it did not act 

within ‘‘a reasonable period of time’’ 

and provided that: (1) the Federal 

licensing or permitting agency 

determines the length of the reasonable 

period of time, and (2) the reasonable 

period of time ‘‘shall generally be 

considered to be six months, but in any 

event shall not exceed one year.’’ See 40 

CFR 121.16(b) (2019). 

The 2020 Rule provided that the 

Federal agency alone sets the reasonable 


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49FERC proposed and finalized regulations to 

codify FERC’s practice of a one-year reasonable 

period of time on natural gas or liquefied natural 

gas infrastructure projects after the 2020 Rule. See 

86 FR 16298 (March 29, 2021). 

50Section 401(a)(1) requires a State or interstate 

agency to establish procedures for public notice in 

the case of all applications for certification by it 

and, to the extent it deems appropriate, procedures 

for public hearings in connection with specific 

applications. However, section 401(a)(1) does not 

set any requirements or time limits on those public 

notice procedures or how those procedures should 

be considered when setting the reasonable period 

of time. Some certifying authorities have public 

notice procedures that exceed the default 

reasonable period of time in place for some Federal 

agencies (e.g., longer than the Corps’ or EPA’s 

Continued 

period of time and defined a process for 

how it should be determined. See 40 

CFR 121.6 (2020). This process specified 

when a Federal agency must 

communicate the reasonable period of 

time to the certifying authority and 

identified factors that the Federal 

agency must consider when setting the 

reasonable period of time. See id.; 85 FR 

42259–60 (July 13, 2020). The 2020 Rule 

did not maintain the 1971 Rule’s sixmonth default and reiterated that the 

reasonable period of time could not 

exceed one year from receipt of the 

certification request. 40 CFR 121.6 

(2020). The 2020 Rule also defined the 

term ‘‘reasonable period of time’’ as the 

length of time during which the 

certifying authority may act on a request 

for certification. 40 CFR 121.1(l) (2020). 

Some Federal agencies promulgated 

regulations describing a reasonable 

period of time for section 401 

certification in relation to those 

agencies’ licenses or permits prior to the 

2020 Rule. For example, FERC has 

explicitly defined the reasonable period 

of time to be one year. See 18 CFR 

4.34(b)(5)(iii), 5.23(b)(2), 157.22(b).49

The Corps has routinely implemented a 

60-day reasonable period of time for 

section 401 decisions commencing 

when the certifying authority receives a 

section 401 certification request. See 33 

CFR 325.2(b)(1)(ii). EPA established a 

60-day reasonable period of time for 

NPDES permits. See 40 CFR 

124.53(c)(3). 

In pre-proposal input on the 

rulemaking, project proponents 

generally supported the reasonable 

period of time provisions in the 2020 

Rule, whereas most states, Tribes, and 

non-governmental organizations 

expressed concern with various aspects 

of it. Some certifying authorities also 

pointed out that short reasonable 

periods of time (e.g., 60 days) do not 

allow the state or authorized Tribe 

sufficient time to fulfill certain state or 

Tribal law requirements, such as public 

notice procedures, or allow them to 

obtain all the information they need 

about a project to make an informed 

certification decision. As a result, these 

certifying authorities asserted that for 

complex projects, their only realistic 

options are to waive or deny 

certification. EPA expressed similar 

concerns in its notice of intent to revise 

the 2020 Rule. See 86 FR 29543 (June 

2, 2021) (‘‘Among other issues, EPA is 

concerned that the rule does not allow 

state and tribal authorities a sufficient 

role in setting the timeline for reviewing 

certification requests . . . .’’). 

The Agency proposed at § 121.6(b) 

that the Federal agency and certifying 

authority may jointly set the reasonable 

period of time on a case-by-case or 

project type basis. Additionally, the 

proposal included a default reasonable 

period of time of 60 days if the Federal 

agency and certifying authority are not 

able to come to an agreement within 30 

days of receipt of the request of 

certification at § 121.6(c). Proposed 

§ 121.6(c) and (d) also introduced 

extensions of the reasonable period of 

time. It was proposed that the 

negotiated or default reasonable period 

of time would automatically be 

extended to accommodate public notice 

and comment processes or due to force 

majeure events. The Federal agency and 

certifying authority could also agree to 

extend the reasonable period of time for 

any reason, provided it did not exceed 

the statutory one-year maximum. Lastly, 

in the proposal, the Agency did not take 

a stance on the legality of the 

withdrawal and resubmittal approach to 

restart the clock. 87 FR 35341–42 (June 

9, 2022). 

Similar to the proposal, this final 

rulemaking not only affirms and 

clarifies that—consistent with the 

statutory text—the reasonable period of 

time may not exceed one year from the 

date the request for certification is 

received, but it also finalizes 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). Under this final rule, in a 

change from proposal, if the Federal 

agency and certifying authority do not 

agree upon the reasonable period of 

time in writing, the default reasonable 

period of time would be six months 

from the date the request for 

certification is received. 40 CFR 

121.6(c). The final rule also allows for 

extensions under certain circumstances. 

40 CFR 121.6(d) and (e). Additionally, 

the Agency is removing as unnecessary 

the definition for ‘‘reasonable period of 

time.’’ See 40 CFR 121.1(l) (2020). Like 

that definition, the final rule language in 

§ 121.6(b) itself provides that the 

reasonable period of time is the time 

during which the certifying authority 

must act on the request for certification. 

As a result, the Agency finds it 

duplicative and unnecessary to include 

a separate definition for the term 

‘‘reasonable period of time.’’ 

a. Reasonable Period of Time 

Determination 

i. Joint Setting of the Reasonable Period 

of Time 

The collaborative approach in this 

final rule (i.e., the Federal agency and 

certifying authority may jointly set the 

reasonable period of time with a default 

of six months if an agreement is not 

reached) differs from the approach in 

both the 1971 Rule and the 2020 Rule 

where the reasonable period of time was 

determined solely by the Federal 

agency. See 40 CFR 121.16(b) (2019); 40 

CFR 121.6(a) (2020). The approach 

taken in the 1971 and 2020 Rules 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 below, 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. Under this approach, 

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.50 Given that 


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current default 60-day reasonable period of time for 

federally issued CWA section 404 and 402 permits). 

51EPA estimates that the average annual number 

of certification requests is 1,947 requests per 

certifying authority. See Supporting Statement for 

the Information Collection Request (ICR). 

EPA is deferring to the combined 

expertise of the Federal agencies and 

certifying authorities for establishing the 

reasonable period of time, this final rule 

does not retain the list of factors that a 

Federal agency shall consider, under the 

2020 Rule at § 121.6(c), when 

establishing the reasonable period of 

time. However, the Agency notes that 

Federal agencies and certifying 

authorities might 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. Importantly, this final 

rule approach addresses state and Tribal 

stakeholders’ concerns that, under the 

2020 Rule, certifying authorities did not 

have enough influence in determining 

the length of the reasonable period of 

time for a particular project. 

Many commenters expressed support 

for the collaborative approach of the 

Federal agency and certifying authority 

setting the reasonable period of time 

together. These commenters said that 

the joint determination is consistent 

with cooperative federalism principles 

and allows certifying authorities to 

provide input as the stakeholder that 

conducts the review of the request for 

certification. Some commenters also 

supported the setting of reasonable 

periods of time through MOAs between 

the Federal agency and certifying 

authority to reduce the need to 

determine the reasonable period of time 

on a case-by-case basis. Commenters 

also suggested that the final rule should 

provide that Federal and state agencies 

can agree to categorical time periods for 

state review of certain types of permits, 

licenses, or projects, pursuant to written 

agreements, which many did before the 

2020 Rule. A few commenters raised 

concerns about the time and resources 

that would be needed to set a reasonable 

period of time for every review of a 

request for certification and suggested 

that the final rule should clarify that 

categorical agreements, in addition to 

case-by-case agreements, are 

permissible. 

While the Agency agrees that the joint 

agreement approach promotes 

cooperative federalism, 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 types of Federal licenses or 

permits. 

Other commenters did not support 

setting the reasonable period of time 

through a joint agreement between the 

Federal agency and certifying authority. 

Some commenters said that EPA should 

remain silent on who sets the reasonable 

period of time and that certifying 

authorities should apply their own 

procedures. Some of these commenters 

argued that the Federal agency should 

not be placed on the same footing as the 

certifying authority in determining the 

reasonable period of time because the 

certifying authority is the expert 

regarding their own procedures, 

resources, and applicable state and 

Tribal laws. Conversely, other 

commenters stated that the Federal 

agency should set the reasonable period 

of time. One commenter stated that 

having a Federal agency set the default 

serves to minimize the arbitrary delays 

and bureaucratic gamesmanship, and 

thus EPA should continue to have 

Federal agencies establish it, as they 

have done for decades. Several 

commenters also expressed concern that 

the collaborative approach would cause 

instability or inefficiencies for various 

reasons, including the fact that there 

could be different reasonable periods of 

time if it is set on a case-by-case basis 

or may differ by certifying authority. 

This joint agreement approach is the 

optimal interpretation of the statute as 

it balances equities between the Federal 

agency and certifying authority and 

utilizes the expertise of both 

stakeholders. EPA disagrees 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 decision-making 

process. And as stated above, 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 

would create efficiency while still 

taking advantage of the knowledge of 

both parties for determining the time 

necessary for reviewing each request for 

certification. 

One commenter asked that the joint 

agreement between the Federal agency 

and the certifying authority be made in 

consultation with the project proponent 

to allow for greater regulatory 

predictability for project proponents 

and reduce any confusion among the 

parties. EPA disagrees that any joint 

agreement between the Federal agency 

and the certifying authority must be 

made in consultation with the project 

proponent. Considering the high annual 

average number of requests for 

certification,51 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 with project proponents 

on every request for certification. 

Consistent with the cooperative 

federalism principles imbued in section 

401, Federal agencies and certifying 

authorities, not project proponents, have 

primary roles in the certification 

process. That is, it is the Federal agency 

whose license or permit is subject to 

section 401, and the certifying authority 

is responsible for determining 

compliance with applicable water 

quality requirements in accordance with 

section 401. 

Additionally, requiring project 

proponent consultation in every case 

would add unnecessary across-theboard procedure and coordination into 

the certification process. 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 serve to 

gather input from project proponents 

that may help in setting the reasonable 

period of time. Federal agencies and 

certifying authorities may also choose to 

include input from project proponents 

when setting categorical reasonable 

periods of time via MOAs. 

Some commenters who also expressed 

concern about the 30-day negotiation 

period between the Federal agency and 

certifying authority in the proposed 


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rule. Some of these commenters stated 

that certifying authorities would need to 

expend their resources on both 

negotiating the reasonable period of 

time and trying to review the request for 

certification due to the clock already 

running during the negotiation period. 

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. 

However, the Agency encourages 

prompt negotiations between the 

Federal agencies and certifying 

authorities for both individually 

determined reasonable periods of time 

and categorical reasonable periods of 

time to give clarity to project 

proponents as early as possible. 

ii. Default Reasonable Period of Time 

Section 401(a)(1) provides that the 

reasonable period of time ‘‘shall not 

exceed one year.’’ 33 U.S.C. 1341(a)(1). 

The phrase ‘‘shall not exceed one year’’ 

means that the reasonable period of time 

need not be one full year and that a 

certifying authority should not 

necessarily expect to be able to take a 

full year to act on a section 401 request 

for certification. If Congress had meant 

for the reasonable period of time to be 

one year in all cases, it would have 

simply written ‘‘shall be one year’’ 

instead of ‘‘shall not exceed one year.’’ 

Under this final rule, the certifying 

authority could be subject to a shorter 

than one-year reasonable period of time 

to render its decision, provided that the 

Federal agency and the certifying 

authority have agreed to a shorter time, 

or as discussed below, when the parties 

do not reach agreement and instead rely 

on the default reasonable period of time 

of six months. This approach is 

consistent with case law. See Hoopa 

Valley Tribe v. FERC, 913 F.3d 1099, 

1104 (D.C. Cir. 2019) (‘‘[W]hile a full 

year is the absolute maximum, it does 

not preclude a finding of waiver prior to 

the passage of a full year.’’). 

As discussed in more detail below, 

many commenters opposed the default 

60-days for a variety of reasons and 

offered alternative reasonable periods of 

time, such as 90 days, 120 days, 180 

days, and one year. For the final rule, 

EPA decided on six months as the 

default reasonable period of time for 

several reasons. First, as stated above, 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 is consistent with 

almost 50 years of program 

implementation under EPA’s 1971 

regulations. Second, 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. Third, 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 period serves as a 

default should Federal agencies and 

certifying authorities fail to agree on a 

different time period. Finally, EPA’s 

proposed 60-day default reasonable 

period of time was based largely on 

EPA’s concurrent proposal to require 

that requests for certification include a 

copy of the draft Federal license or 

permit. Since the certifying authority 

would have more information upfront 

(the draft Federal license or permit 

instead of only the application), the 

Agency proposed that the default 

reasonable period of time could be 

shorter. But since EPA has decided not 

to finalize the proposed draft Federal 

license or permit requirement (for 

individual Federal licenses and permits) 

and instead only require that a request 

for certification include the Federal 

license or permit application, certifying 

authorities will have less information 

and may need more time to review 

requests for certification, hence the sixmonth default reasonable period of time 

(which only applies if the certifying 

authority and Federal agency do not 

agree on an alternative). 

Although EPA proposed 60 days as 

the default reasonable period of time, 

the Agency requested comment on 

whether and, if so, why the default 

should be longer than 60 days (e.g., 120 

days, six months, one year). 87 FR 

35339–40 (June 9, 2022). EPA noted that 

the default may depend on when 

certification is requested during the 

Federal licensing or permitting process, 

e.g., if EPA were to decide that a draft 

Federal license or permit is not a 

required component of a certification 

request, a longer default reasonable 

period of time may be appropriate. Id. 

Based on comments received on the 

proposed rule, it seems that many, if not 

most, commenters would support a sixmonth default reasonable period of 

time, as described in this section. 

A few commenters supported the 

proposed 60-day default and pointed 

out that certifying authorities often 

review many simpler projects in 30 days 

or less, and in some jurisdictions, 

applicable law already requires 

certifying authorities to approve or deny 

the certification request within 60 days 

of receipt of a complete application. A 

few commenters argued that the 60-day 

default would ensure consistency and 

predictability for stakeholders. One 

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. Relatedly, other 

commenters opined 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. 

EPA agrees in part and disagrees in 

part with these comments. 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. EPA 

disagrees that 60 days as a default 

reasonable period of time for all projects 

is practical for the reasons provided in 

the Agency’s rationale above, 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 

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 encourages certifying 

authorities and Federal agencies to enter 

into categorical agreements that will 

allow project proponents to anticipate 

timelines for certification processes. The 

default reasonable period of time would 

not apply if the Federal agency and 

certifying authority agree to a different 

time. EPA does not agree that Federal 

agency defaults in regulation that are 

less than one year should supersede the 


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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 oneyear 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. In these 

circumstances, individual written 

agreements for each request for 

certification would not be necessary, 

since a negotiation between the 

certifying authority and Federal agency 

would not need to occur. 

Most commenters opposed the 60-day 

default reasonable period of time. 

Commenters noted that while 60 days 

may be enough time for simpler or more 

routine projects, which may include 

some projects covered by general or 

nationwide permits, 60 days would be 

insufficient for especially novel, 

complicated, controversial, or complex 

projects. Some commenters provided 

various examples of such project types, 

including FERC pipeline authorizations, 

relicensing of hydroelectric dams, water 

supply projects, liquefied natural gas 

(LNG) terminals, deep-water ports, and 

projects that trigger the need for an 

environmental impact statement (EIS) or 

multiple Federal permits. Commenters 

also added that each request is different 

and carries unique implications to be 

examined based on the specific 

characteristics of the water bodies and 

proposed project and Federal license or 

permit in question. Some commenters 

said that because the proposed rule 

would require agreement between the 

Federal agency and certifying authority 

on a different amount of time, the 

proposal would effectively and 

inappropriately give Federal agencies 

veto power over certifying authorities, 

infringing on principles of collaborative 

federalism. Commenters also said that 

states and Tribes know their own 

procedures, resources, and applicable 

requirements and should have input 

into deciding the length of the 

reasonable period of time. Lastly, 

commenters argued that the 60-day 

default would be inadequate if the final 

rule does not require submittal of the 

draft Federal license or permit in a 

request for certification, noting that the 

proposed default appeared to be 

predicated on the assumption that the 

‘‘request’’ the certifying authority will 

receive will include a draft Federal 

license or permit. 

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. As discussed above, Federal 

agencies and certifying authorities offer 

different types of relevant expertise for 

setting the reasonable period of time, 

and EPA encourages them to establish 

categorical 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 (half of the maximum one year) 

in the event an agreement cannot be 

reached. EPA acknowledges that 60 

days may not be a sufficient default for 

certain project types and has 

accordingly shifted the default 

reasonable period of time to six months. 

However, the Agency emphasizes that 

the default only applies in the absence 

of a written agreement between the 

certifying authority and Federal agency, 

either categorically or on a case-by-case 

basis. The Agency encourages 

consideration of project complexities 

when setting the reasonable period of 

time. 

Some commenters alleged that the 

proposed default reasonable period of 

time is contrary to the plain language 

and intent or purpose of CWA section 

401. These commenters said Congress 

did not authorize EPA to contravene the 

statute by mandating action, or allowing 

the Federal agency to mandate action, in 

less than one year; and if there should 

there be any default, it should simply be 

the one year allowed under the statute. 

EPA disagrees with these commenters. 

As discussed above, 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. As stated 

above, 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 this section, 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-bycase or categorical basis. 

b. Extensions to the Reasonable Period 

of Time 

As mentioned previously, the final 

rule provides that Federal agencies and 

certifying authorities may agree to 

extend the reasonable period of time, 

provided it does not exceed the 

statutory one-year limit. Additionally, 

there may be circumstances where the 

established or default reasonable period 

of time is not sufficient to allow the 

certifying authority to complete its 

review. Therefore, the final rule 

provides automatic extensions to 

accommodate public notice procedures 

or due to force majeure events. In these 

two circumstances, the reasonable 

period of time is extended by the time 

needed by public notice procedures or 

the force majeure event, which would 

be communicated in the written 

justification by the certifying authority 

to the Federal agency. 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, and this language is 

consistent with the final rule language 

for certification decisions and Federal 

agency review at §§ 121.7 and 121.8. 

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 


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52See footnote 51. 

certification is received. The statute also 

does not specify who may extend the 

reasonable period of time or the terms 

on which it may be extended. The 1971 

Rule was also silent on extensions. 

However, 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)(1)(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.’’). The 2020 Rule 

allowed certifying authorities to request 

an extension of the reasonable period of 

time. 40 CFR 121.6(d) (2020). However, 

only the Federal agency had the power 

to extend the reasonable period of time. 

Id.; see also 85 FR 42260. Under the 

2020 Rule, the Federal agency was not 

required to grant extension requests. See 

40 CFR 121.6(d)(2) (2020). As a result, 

Federal agencies 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. 

The Agency proposed at § 121.6(d) to 

allow certifying authorities and Federal 

agencies to jointly extend the reasonable 

period of time in a written agreement, 

as long as the project proponent was 

consulted, and the extension did not 

exceed one year from the receipt of 

request for certification. The Agency 

also recognized that there were 

circumstances under which the Federal 

agency should extend the reasonable 

period of time without the certifying 

authority needing to negotiate an 

agreement. Accordingly, the Agency 

proposed at § 121.6(c) to identify two 

scenarios that would require the 

extension of the reasonable period of 

time: force majeure events and public 

notice procedures. Under the proposed 

rule, the certifying authority had to 

notify the Federal agency through a 

written justification prior to the end of 

the reasonable period of time. Upon 

notification, the reasonable period of 

time would be extended by the period 

needed to fulfill public notice 

procedures or the force majeure event, 

provided such extension did not exceed 

one year from receipt of the request for 

certification. 

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) and 

(e). The final rule approach balances 

Federal agency and certifying authority 

equities better than the 1971 Rule and 

the 2020 Rule for the reasons explained 

in this section. This approach is 

consistent with the approach for joint 

establishment of the reasonable period 

of time. It also aligns with cooperative 

federalism principles central to the 

CWA. Although the Agency is not 

finalizing the requirement to consult 

with the project proponent, the final 

rule does allow for input from the 

project proponent. The certifying 

authority and Federal agency should 

communicate any extensions to the 

reasonable period of time to the project 

proponent. 

Most of the commenters who 

addressed extensions of the reasonable 

period of time supported allowing 

certifying authorities and Federal 

agencies to agree to extensions. A few 

commenters said that the Federal 

agency should have the sole discretion 

to extend the reasonable period of time, 

and another commenter said that the 

certifying authority should be the only 

one to determine the extension. One 

commenter suggested that extensions 

should be granted only if EPA finds that 

unusual circumstances require a longer 

time. Some commenters recommended 

that the project proponent should also 

be engaged in the determination of 

extending the reasonable period of time. 

Multiple commenters said that 

extensions agreed on by the Federal 

agency and certifying authority should 

have justifiable and reasonable limits 

that address the concerns of the project 

proponent. Conversely, other 

commenters recommended that project 

proponents not be consulted but rather 

notified about any extensions. 

Consistent with the final rule’s 

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 extensions, provided any 

extension does not exceed one year from 

the receipt of the request for 

certification. 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. 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 § 121.6(b), so it is unnecessary to 

provide the project proponent with a 

role in extensions. Additionally, 

considering the annual average number 

of certification requests,52 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. EPA also 

notes that 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: 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 takes longer than the negotiated 

or default reasonable period of time. 

All commenters who addressed 

extensions of the reasonable period of 

time expressed support for extensions 

due to unforeseen circumstances such 

as government closures or force majeure 

events. Several commenters suggested 

that extensions should be limited only 

to such events and not include public 

comment and other known procedures 

that were in place at the time the 

reasonable period of time was 

established. 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 supported defining 

specific situations warranting 

extensions for efficiency and 

predictability, while a few commenters 

stated that the final rule should not 


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53The court held that the project proponent and 

the certifying authorities (California and Oregon) 

had improperly entered into an agreement whereby 

the ‘‘very same’’ request for state certification of its 

relicensing application was automatically 

withdrawn and resubmitted every year for a decade 

by operation of ‘‘the same one-page letter’’ 

include a defined list that would limit 

the circumstances under which an 

extension can occur. 

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 automatic 

extensions 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. However, 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. 

Some commenters noted that the rule 

should provide more clarity such as 

specifically defining public notice 

procedures and providing more details 

on how extensions would work. In 

response to these comments, the Agency 

has revised § 121.6 to clearly 

differentiate automatic extensions from 

agreed-upon extensions. Additionally, 

the Agency has revised what is now 

§ 121.6(d) to clarify that in the certifying 

authority’s written notification to the 

Federal agency, it must identify how 

much additional time is required by 

either the public notice procedures or 

the force majeure event in addition to 

the justification for such extension. 

c. Withdrawal and Resubmissions of 

Requests for Certification 

As proposed, EPA is removing 

§ 121.6(e) from the 2020 Rule, which 

prohibited the certifying authority from 

asking the project proponent to 

withdraw the certification request to 

reset the reasonable period of time. 

Instead, the Agency is finalizing as 

proposed to take no position on the 

legality of withdrawing and 

resubmitting a request for certification. 

Several commenters expressed 

opposition regarding EPA’s decision not 

to retain the 2020 Rule’s regulatory text 

at § 121.6(e) and the approach not to 

take a position on the permissibility of 

withdrawing and resubmitting a request 

for certification. Some commenters 

supported the 2020 Rule’s position on 

withdrawals and resubmittals, stating 

that this position has helped ensure that 

the certification process cannot be 

misused to delay or prevent issuance of 

the Federal license or permit. 

Commenters expressed concern that 

EPA’s proposed approach to refrain 

from taking a position on the legality of 

withdrawing and resubmitting a request 

for certification suggested that this 

process may be used as a loophole to 

circumvent the one-year time limit 

described in section 401, which would 

increase uncertainty, costs, and 

indefinitely delay Federal licensing or 

permitting processes, especially if there 

is an increase in litigation. Most of the 

commenters opposed to EPA’s proposed 

approach pointed out that Congress was 

clear in its 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). 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. 

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 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. To be clear, EPA 

does not find that mere coordination 

between the certifying authority and 

project proponent, as encouraged 

throughout this preamble, rises to a 

withdrawal and resubmittal scheme. 

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 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. 

Other commenters expressed support 

for EPA’s proposed approach of not 

taking a position on the legality of 

withdrawal and resubmittal. Some 

commenters acknowledged that 

flexibility is important for project 

proponents and certifying authorities, 

while others described the need for 

more guidance to reduce litigation on 

the withdrawal and resubmittal 

practice. Conversely, some commenters 

expressed support for withdrawal and 

resubmission in certain situations, 

encouraging EPA to make clear in the 

final rule 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 commenters 

asserted that withdrawal and 

resubmission of requests for 

certification may occur to avoid denials 

of certification, and a few 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. 

EPA recognizes that the practice of 

withdrawal and resubmittal has been 

subject to litigation. The 2020 Rule 

prohibited the certifying authority from 

asking the project proponent to 

withdraw the certification request to 

reset the reasonable period of time. 40 

CFR 121.6(e) (2020). In support of that 

position, the 2020 Rule relied on a 

broad reading of the D.C. Circuit’s 

decision in Hoopa Valley Tribe and 

asserted that the regulatory text at 

§ 121.6(e) is a ‘‘clear statement that 

reflects the plain language of section 

401 and . . . is supported by the 

legislative history.’’ 85 FR 42261. In that 

case, which featured highly unusual 

facts,53 the court rejected the particular 


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repeatedly submitted to the states before the 

statute’s one-year waiver deadline. 913 F.3d at 

1104. 

54The respondent-intervenors in the Ninth 

Circuit case petitioned the Supreme Court for 

certiorari but the Supreme Court denied the petition 

on May 15, 2023. Nevada Irrigation District, et al. 

v. Cal. State Water Res. Control Bd., et al., Docket. 

No. 22–753. 

55Historically, certifying authorities and project 

proponents have used the ‘‘withdraw and resubmit’’ 

approach for dealing with the one-year deadline for 

complex projects. There are a multitude of 

permutations, but the basic idea is that the project 

proponent would withdraw the certification request 

and then resubmit a new certification request either 

immediately or at some later date. 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. 

‘‘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).54 Additionally, 

EPA’s guidance prior to the 2020 Rule 

acknowledged use of the withdrawal 

and resubmittal approach, as well as the 

‘‘deny certification without prejudice to 

refile’’ approach, but noted that ‘‘[t]his 

handbook does not endorse either of the 

two approaches. . . .’’ 2010 Handbook 

at 13, n.7 (rescinded in 2019, see supra). 

With the dynamic case law related to 

the topic of withdrawal and resubmittal 

and the complexities of certain 

certification situations,55 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. This final rule 

approach resets EPA’s interpretive 

position to silent and neutral on 

withdrawal and resubmittal, where it 

was before the 2020 Rule. 

3. Implementation 

As previously explained, EPA has 

added regulatory text to clarify that the 

certifying authority and Federal agency 

may enter into written agreements that 

establish categorical reasonable periods 

of time for certain types of Federal 

licenses or permits. This regulatory text 

gives the certifying authority and 

Federal agency the option of 

establishing the reasonable period of 

time for certain categories of Federal 

licenses or permits at any time without 

needing to wait until a Federal license 

or permit application (or draft general 

Federal license or permit) is submitted. 

For example, the certifying authority 

and Federal agency could enter into an 

agreement that establishes a reasonable 

period of time for all NPDES permits or 

for certain categories of NPDES permits 

such as some general permits or minor 

individual permits. The addition of the 

regulatory text regarding written 

agreements was supported by some 

commenters who stated that the final 

rule should allow the Federal agency 

and certifying authority to agree in 

writing to categorical time periods for 

the certifying authority to review certain 

types of permits, licenses, and/or 

projects. These commenters noted that 

this was done prior to the 2020 Rule, 

and in the past, such agreements 

improved efficiency and predictability 

by allowing Federal agencies, certifying 

authorities, and project proponents (if 

applicable) to understand the reasonable 

period of time prior to submitting an 

application. EPA agrees that the 

addition of the regulatory text will allow 

for more efficiency and predictability. 

Commenters also noted that the 

proposed rule stated that the reasonable 

period of time must be agreed upon 

within 30 days of the receipt of request 

for certification, which suggested that 

categorical agreements entered into 

prior to the date that the request for 

certification was received would not 

satisfy the regulatory requirement. EPA 

has addressed this concern by deleting 

the phrase ‘‘within 30 days of receipt of 

a request for certification.’’ By deleting 

this phrase, the regulation makes clear 

that the Federal agency and certifying 

authority may agree to a reasonable 

period of time through written 

agreements that can be entered into 

prior to a request for certification. 

Several commenters identified 

specific types of permits and/or 

processes that require a longer 

reasonable period of time than the 

proposed 60-day default. Specifically, 

several commenters stated that the 60- 

day default reasonable period of time 

would not align with the concurrent 

Federal consistency reviews that are 

required for some projects pursuant to 

the Coastal Zone Management Act 

(CZMA). In addition, several 

commenters noted that FERC pipeline 

authorizations or relicensing of 

hydroelectric dams can require up to 

one year. 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 above, 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. 

E. Scope of Certification 

1. What is the Agency finalizing? 

The Agency is finalizing its proposed 

approach to the scope of certification at 

§ 121.3 with modifications to the 

regulatory text to better clarify the 

extent of the activity subject to 

certification and the water quality 

limitations inherent to section 401. 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. In addition, EPA’s final rule 

makes clear that a certifying authority’s 

review is limited to considering impacts 

to waters of the United States except 

where a state or authorized Tribe has 


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state or Tribal laws that apply to waters 

of the state or Tribe. 

The 2020 Rule substantially narrowed 

the scope of a certifying authority’s 

review. Before the 2020 Rule, a 

certifying authority considered whether 

the whole ‘‘activity’’ subject to the 

Federal license or permit will comply 

with applicable water quality 

requirements. Under the 2020 Rule, the 

certifying authority could only consider 

potential water quality impacts from the 

project’s point source ‘‘discharges.’’ See 

85 FR 42229 (July 13, 2020). This 

interpretation was heavily criticized by 

many states, Tribes, and nongovernmental organizations as 

unlawfully narrowing the certifying 

authorities’ scope of review under 

section 401 and was subject to multiple 

legal challenges. 

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 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. Consistent 

with this interpretation, EPA is 

finalizing revisions to § 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 § 121.3 

that clarify important limiting 

principles and provide greater 

regulatory certainty. 

The final rule at § 121.3 provides that 

when a certifying authority reviews a 

request for certification, the certifying 

authority ‘‘shall evaluate whether the 

activity will comply with applicable 

water quality requirements.’’ It further 

provides that the certifying authority’s 

evaluation by the certifying authority is 

‘‘limited to the water quality-related 

impacts from the activity subject to the 

Federal license or permit, including the 

activity’s construction and operation.’’ 

Finally, it provides that a certifying 

authority ‘‘shall include any conditions 

in a grant of certification necessary to 

assure that the activity will comply with 

applicable water quality requirements.’’ 

40 CFR 121.3 

The final rule adopts the proposed 

scope of certification but with textual 

edits made in response to public 

comment. First, the final rule no longer 

divides its regulatory text regarding 

scope between two separate sections of 

part 121. The Agency proposed a 

definition of ‘‘activity as a whole’’ at 

§ 121.1 and also addressed scope of 

certification at § 121.3. After 

considering public comment, the 

Agency finds this structure unnecessary 

and confusing and instead has 

incorporated its full interpretation of 

scope in final rule § 121.3. See section 

IV.E.2.b of this preamble for further 

discussion. 

Second, the Agency removed the 

phrase ‘‘as a whole’’ from the regulatory 

text throughout part 121. This does not 

represent a change in substance from 

proposal. The Agency does not interpret 

the terms ‘‘activity’’ and ‘‘activity as a 

whole’’ as having different meanings; 

rather, EPA included the phrase ‘‘as a 

whole’’ in the proposed rule simply to 

emphasize that a certifying authority’s 

evaluation extends to the activity in its 

entirety, as opposed to only the point 

source discharges associated with the 

activity. After considering public 

comment and the statutory text, EPA 

concludes that the final regulatory text 

at § 121.3 makes this clear without the 

need to add ‘‘as a whole’’ and best 

reflects the statutory text. See section 

IV.E.2.b of this preamble for further 

discussion. 

Third, the final rule adds regulatory 

text clarifying that a certifying 

authority’s evaluation ‘‘is limited to the 

water quality-related impacts’’ from the 

activity subject to the Federal license or 

permit. This is not a change in 

substance from proposal. This concept 

was captured in the proposed definition 

of activity as a whole at § 121.1(a) 

(‘‘activity as a whole means any aspect 

of the project activity with the potential 

to affect water quality) and, in the 

preamble at proposal, EPA was clear 

that section 401 is limited to addressing 

only water quality-related impacts. 87 

FR 35343 (June 9, 2022). EPA finds that 

this clarification best reflects the 

statutory language and purpose of 

section 401. See section IV.E.2.c of this 

preamble for further discussion. 

Fourth, the proposal defined ‘‘activity 

as a whole’’ to mean any aspect of the 

activity ‘‘with the potential’’ to affect 

water quality. As discussed above, EPA 

is not finalizing that definition, and 

further, the final regulatory text does not 

refer to ‘‘potential’’ to affect water 

quality. 40 CFR 121.3(a). EPA made this 

change in response to several 

commenters who questioned the 

breadth of the term ‘‘potential,’’ 

suggesting that the term ‘‘potential’’ 

authorized certifying authorities to 

consider purely speculative ‘‘potential’’ 

impacts to water quality. EPA did not 

intend for its proposed language to 

establish the required degree of 

causality between the activity and the 

impact to water quality. The Agency 

finds it unnecessary to do so in this 

rulemaking. Consistent with the 

statutory text and purpose of section 

401, final rule § 121.3 clearly limits a 

certifying authority’s analysis of any 

given activity to the water qualityrelated 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. 

See section IV.E.2.b of this preamble for 

further discussion. 

Fifth, § 121.3(b) provides that the 

scope of conditions in a grant of 

certification is the same as the scope of 

review when acting on a request for 

certification; certifying authorities are to 

impose conditions ‘‘necessary to assure 

that the activity will comply with 

applicable water quality requirements.’’ 

This is not a change in substance from 

proposal. Proposed rule § 121.7(d)(2) 

included the same concept by requiring 

a grant with conditions to include 

‘‘[a]ny conditions necessary to assure 

that the activity as a whole will comply 

with water quality requirements,’’ and 

EPA was clear at proposal that the scope 

for the purpose of including conditions 

in a certification and the scope of 

review for purposes of whether to grant 

certification are the same. 87 FR 35346. 

EPA continues to find this 

interpretation best aligns with the 

statutory text and purpose of section 

401. See section IV.E.2.e of this 

preamble for further discussion. 

Next, EPA’s final regulatory text 

provides that the certifying authority’s 

evaluation of the activity includes ‘‘the 

activity’s construction and operation.’’ 

At proposal, EPA explained that it did 

not intend for its proposed scope to 

cover only those portions of the activity 

directly authorized by Federal license or 

permit in question. 87 FR 35346. EPA 

specifically requested comment on this 

interpretation. Id. After considering 

comments and the statutory text of 

section 401, EPA is finalizing its 

proposed interpretation and including 

regulatory text to reflect it. Specifically, 

final rule § 121.3(a) states that the 

certifying authority’s evaluation 

includes ‘‘the activity’s construction 

and operation’’ without reference to 

whether the Federal license or permit at 

issue covers both aspects of the activity. 


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56All EPA interpretations of scope prior to the 

2020 Rule reflected the ‘‘activity’’ or ‘‘project’’ 

scope affirmed in PUD No. 1 and reinstated in this 

final rule. See e.g., Memorandum from Catherine A. 

Winer to David K. Sabock, Section 401 Certification 

of Marina (Nov. 12, 1985) (hereinafter, Winer 

Memorandum) (concluding that ‘‘section 401 may 

reasonably be read as . . . allowing state 

certifications to address any water quality standard 

violation resulting from an activity for which a 

certification is required, whether or not the 

violation is directly caused by a ‘discharge’ in the 

narrow sense’’); 1989 Guidance at 22 (‘‘[I]t is 

imperative for a State review to consider all 

potential water quality impacts of the project, both 

direct and indirect, over the life of the project.’’); 

2010 Handbook at 17 (rescinded in 2019, see supra) 

(‘‘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.’’). 

The Agency focused on construction 

and operation because those are the two 

aspects of an activity that Congress 

referenced throughout section 401. See 

section IV.E.2.b of this preamble for 

further discussion. 

The Agency is also finalizing the 

definition of ‘‘water quality 

requirements’’ at § 121.1(j) as proposed 

(‘‘Water quality requirements means any 

limitation, standard, or other 

requirement under sections 301, 302, 

303, 306, and 307 of the Clean Water 

Act, any Federal and state or Tribal laws 

or regulations implementing those 

sections, and any other water qualityrelated requirement of state or Tribal 

law’’). The 2020 Rule narrowed the 

ability of certifying authorities to 

include conditions in their certifications 

pursuant to section 401(d) to protect the 

quality of their waters. Before the 2020 

Rule, a certifying authority could add 

conditions to its certification as 

necessary to assure compliance with the 

specifically enumerated sections of the 

CWA and ‘‘any other appropriate 

requirement of State [or Tribal] law.’’ 33 

U.S.C. 1341(d). In the 2020 Rule, 

however, EPA promulgated a narrow 

regulatory interpretation of the section 

401(d) term ‘‘other appropriate 

requirements of State law,’’ limiting it to 

‘‘state or tribal regulatory requirements 

for point source discharges into waters 

of the United States.’’ 40 CFR 121.1(n), 

121.3 (2020); see also 85 FR 42250. In 

this rulemaking, EPA is returning to an 

interpretation of ‘‘any other appropriate 

requirement of State law’’ that is more 

closely aligned with the statutory text 

and more environmentally protective. 

See further discussion at section 

IV.E.2.c of this preamble. 

The Agency also is finalizing an 

interpretation regarding which waters a 

certifying authority can consider when 

determining whether to grant 

certification. After considering public 

comment, the Agency concludes that a 

certifying authority is limited to 

considering ‘‘navigable waters’’ as 

defined in the CWA, except where a 

state or authorized Tribe has state or 

Tribal laws that apply to waters of the 

state or Tribe. This interpretation is 

supported by the text of section 401 and 

reflected in prior Agency guidance. See 

section IV.E.2.d of this preamble for 

further discussion. 

As discussed below, the 

interpretations in this final rule of 

section 401’s scope of review and 

conditions reflect the best reading of the 

statute. Even if some commenters may 

disagree that these interpretations 

reflect the best reading, there can be no 

doubt that they are imminently 

reasonable, for the same reasons 

articulated below for why EPA’s 

interpretation represents the best 

reading. They also advance the water 

quality protection goals of section 401, 

are consistent with the principles of 

cooperative federalism that underlie the 

CWA and especially section 401, and 

restore the full measure of authority that 

Congress intended to grant states and 

authorized Tribes to protect their 

critical water resources. 

2. Summary of Final Rule Rationale and 

Public Comment 

The following subsections describe 

the Agency’s finalization of the five key 

aspects of the scope of a certification: (a) 

return to activity scope of certification; 

(b) defining the ‘‘activity’’ subject to 

certification; (c) water quality 

requirements; (d) waters considered in 

acting on a request for certification, and 

(e) scope of conditions. 

a. Return to ‘‘Activity’’ Scope of 

Certification Review and Conditions 

Consistent with the proposal, EPA is 

returning the scope of certification 

review and conditions to the ‘‘activity’’ 

subject to the Federal license or permit. 

EPA is returning to the ‘‘activity’’ scope 

because it 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. After 

reviewing the considerable number of 

comments received on this aspect of the 

proposed rule, EPA concludes that the 

‘‘activity’’ interpretation of scope 

affirmed by the Supreme Court in 1994 

best reflects the statutory text, history, 

and purpose of CWA section 401. By 

allowing states and authorized Tribes to 

protect their water quality from the full 

activity made possible by a Federal 

license or permit, this interpretation 

also 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, e.g., 

116 Cong. Rec. 8984 (1970) (explaining 

that the new certification provisions 

were meant to ensure that ‘‘[n]o State 

water pollution control agency will be 

confronted [with] a fait accompli by an 

industry that has built a plant without 

consideration of water quality 

requirements’’). Although this is a 

reversal of the approach taken by the 

Agency in 2020, any disruption to the 

certification process will be manageable 

in part because this final rule realigns 

scope with well-established practice for 

the nearly 50 years preceding the 2020 

Rule, and all prior EPA interpretations, 

some dating from the 1980s.56 Also, the 

2020 Rule, departing from this 

longstanding regime, was in effect for 

only a few years. Further, the final rule 

addresses stakeholder concerns 

regarding the pre-2020 Rule landscape 

and provides regulatory certainty by 

clarifying important concepts such as 

how certifying authorities are limited to 

considering adverse impacts to water 

quality. 

While disruption to the certification 

process will be modest, the additional 

protections to water quality, on the 

other hand, are significant. As 

commenters observed, the distinction 

between certifying the activity and 

certifying only its associated discharges 

is more than semantic and can in some 

cases have significant consequences. A 

point source discharge emanates from a 

‘‘discernible, confined and discrete 

conveyance.’’ 33 U.S.C. 1362(14). 

Impacts to water quality from point 

source discharges are a small subset of 

the water quality impacts that may 

result from a federally licensed or 

permitted activity. For example, as 

commenters observed, there are many 

situations where reductions in stream 

flows or increases in thermal loading 

caused by aspects of the federally 

licensed or permitted activity not 

directly related to point source 

discharges can have devastating impacts 

on a waterbody or watershed. This can 

be especially true in the dam context (at 

issue in PUD No. 1), where construction 

and operation unrelated to point source 

discharges can cause, among other 

adverse water quality effects, a change 

in the timing and flow of water, 

blockage of nutrients, and altered 

chemical makeup of water due to 

reservoirs. But even beyond the dam 

context, the additional water quality 

protections offered by an ‘‘activity’’- 

based scope may be significant for 

certain types of federally licensed or 


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57Note that, as EPA felt the Supreme Court need 

not reach the question of the scope of certification 

in PUD No. 1, the Agency did not directly address 

this issue in its amicus brief. The amicus brief filed 

by the Solicitor General on behalf of the EPA in this 

case did not grapple directly with the language in 

sections 401(a) and (d), and argued that ‘‘[e]ven if 

a condition imposed under Section 401(d) were 

valid only if it assured that a ‘discharge’ will 

comply with the State’s water quality standards, the 

Section 40l(d) condition imposed by the State in 

this case satisfies that test.’’ Brief for the United 

States as Amicus Curiae Supporting Affirmance, 

PUD No. 1, No. 92–1911 at 11, 12 fn. 2. (Dec. 1993). 

58 It is also instructive to note that a unanimous 

Supreme Court left PUD No. 1 untouched in S.D. 

Warren, which found that ‘‘[s]tate certifications 

under [section] 401 are essential in the scheme to 

preserve state authority to address the broad range 

of pollution . . .’’ 547 U.S. at 386. 

permitted activities, such as the 

construction and operation of a pipeline 

project. See supra section IV.E.2.a.iv of 

this preamble. Moreover, as explained 

in the following sections, an ‘‘activity’’- 

based scope is consistent with the 

longstanding Supreme Court precedent 

of PUD No. 1 and bolstered by 

additional textual support and the 

legislative history. 

i. The Supreme Court in PUD No. 1 

Affirmed the Proper Scope of 

Certification 

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. Id. at 711–12. 

Before the Court was a section 401 

certification issued by the State of 

Washington for a new hydroelectric 

project on the Dosewallips River. The 

principal dispute in PUD No. 1 was 

whether a certifying authority could 

require a minimum stream flow as a 

condition in its section 401 certification. 

The project applicant identified two 

potential discharges from its proposed 

hydroelectric facility: ‘‘the release of 

dredged and fill material during 

construction of the project, and the 

discharge of water at the end of the 

tailrace after the water has been used to 

generate electricity.’’ Id. at 711. The 

project applicant argued that because 

the minimum stream flow condition 

was unrelated to these discharges, it was 

beyond the scope of the state’s authority 

under section 401. Id. 

The Court examined sections 

401(a)(1) and 401(d), specifically the use 

of different terms in those paragraphs, to 

inform its interpretation of the scope of 

a section 401 certification. The Supreme 

Court, recognizing the ambiguity created 

when in 1972 Congress amended the 

language in section 401(a)(1) and added 

section 401(d), held that section 401(d) 

‘‘is most reasonably read’’ as authorizing 

the certifying authority to place 

conditions on the ‘‘activity as a whole’’ 

once the predicate existence of a 

discharge is satisfied. Id. at 711–12. EPA 

agrees that section 401 is ambiguous 

regarding the scope of certification and 

conditions, and EPA agrees with the 

Court’s textual analysis of the statute. 

The Court reasoned: 

If § 401 consisted solely of subsection (a), 

which refers to a state certification that a 

‘‘discharge’’ will comply with certain 

provisions of the Act, petitioners’ assessment 

of the scope of the State’s certification 

authority would have considerable force. 

Section 401, however, also contains 

subsection (d), which expands the State’s 

authority to impose conditions on the 

certification of a project. Section 401(d) 

provides that any certification shall set forth 

‘‘any effluent limitations and other 

limitations . . . necessary to assure that any 

applicant’’ will comply with various 

provisions of the Act and appropriate state 

law requirements. 33 U.S.C. 1341(d) 

(emphasis added). The language of this 

subsection contradicts petitioners’ claim that 

the State may only impose water quality 

limitations specifically tied to a ‘‘discharge.’’ 

The text refers to the compliance of the 

applicant, not the discharge. Section 401(d) 

thus allows the State to impose ‘‘other 

limitations’’ on the project in general to 

assure compliance with various provisions of 

the Clean Water Act and with ‘‘any other 

appropriate requirement of State law.’’ 

Although the dissent asserts that this 

interpretation of § 401(d) renders § 401(a)(1) 

superfluous, post, at 726, we see no such 

anomaly. Section 401(a)(1) identifies the 

category of activities subject to certification— 

namely, those with discharges. And § 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 (emphasis in original).57

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). 

Because section 401(d) requires that a 

section 401(a)(1) certification include 

conditions necessary to assure the 

‘‘applicant . . . will comply’’ with 

water quality requirements, section 401 

is most reasonably read to require the 

certifying authority—when it reviews a 

request for certification under section 

401(a)(1)—to review the applicant’s 

activity subject to the Federal license or 

permit, and not merely the potential 

point source discharges. This is the best 

interpretation of the combined text of 

sections 401(a)(1) and 401(d) partly 

because it accounts for the fact that the 

activity is made possible by the 

applicant’s Federal license or permit, 

and that activity might involve a wide 

range of actions beyond any potential 

discharge that could significantly affect 

compliance with water quality 

requirements. In order to assure—as it 

must under section 401(d)—that the 

‘‘applicant’’ will comply with all 

applicable water quality requirements, 

the certifying authority must be able to 

evaluate water quality-related impacts 

from the activity made possibly by the 

applicant’s license or permit beyond 

those related to its triggering 

discharge(s). 

As suggested by the Court, it is 

significant that Congress chose to use 

the term ‘‘applicant’’ in section 401(d), 

which it added to section 401 at the 

same time that it changed ‘‘activity’’ to 

‘‘discharge’’ in section 401(a)(1). 

Congress could easily have used the 

term ‘‘discharge’’ in section 401(d) as it 

did in section 401(a)(1) in place of 

‘‘applicant’’ and chose not to. Congress 

used similar phrasing in other parts of 

the CWA. For example, CWA section 

402 contemplates that an NPDES permit 

may issue only upon a showing that a 

‘‘discharge will meet’’ various 

enumerated provisions. 33 U.S.C. 

1342(a). Congress could have used the 

same term (discharge) in section 401(d) 

but it did not. EPA’s interpretation of 

section 401 accounts for the distinct 

language Congress employed. See 

Transbrasil S.A. Linhas Aereas v. U.S. 

Dep’t of Transp., 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)). 

In conclusion, 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 below, 

has identified additional support for the 

Agency’s interpretation in the statutory 

text of section 401, the legislative 

history of section 401, the water quality 

protection goals of section 401, and the 

principles of cooperative federalism that 

underlie the CWA.58

ii. Additional Textual Support for 

‘‘Activity’’ Scope of Certification 

In PUD No. 1, the Court focused its 

analysis on sections 401(a)(1) and (d). 

However, additional text in section 

401(a)(1) and section 401(a)(3)–(5) adds 


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59Specifically, the provision lists ‘‘an applicable 

effluent limitation or other limitation under 

sections 1311(b) and 1312 [301(b) and 302] of this 

title, and . . . an applicable standard under 

sections 1316 and 1317 [306 and 307] of this title.’’ 

As discussed infra at section IV.E.2.c of this 

preamble, section 301(b), specifically section 

301(b)(1)(C), incorporates by reference section 303, 

and section 303 is not limited to regulating point 

source discharges. 

60The provision goes on to say that any such 

certification (of no applicable water quality 

requirements) ‘‘shall not be deemed to satisfy 

section 1371(c),’’ i.e., CWA section 511(c) 

(pertaining to the National Environmental Policy 

Act of 1969, 42 U.S.C. 4321 et seq. (NEPA)). 

61See 87 FR 35344–45 (discussing section 

401(a)(3)–(5) in support of an ‘‘activity’’ based 

scope of certification). 

62While Congress was otherwise engaged in a 

‘‘total restructuring’’ of the CWA in 1972, 

Milwaukee v. Illinois, 451 U.S. 304, 317 (1981) 

(quoting legislative history of the 1972 

amendments), Congress deemed the water quality 

certification scheme so important that Congress 

carried it over, largely unchanged. Much of the 

legislative history of the 1972 amendments focuses 

on the total restructuring of the act, not explaining 

the pre-existing certification requirement. The 

legislative history is accordingly relatively sparse 

regarding certification. Much of the discussion that 

does exist concerns the change from certifying 

compliance with ‘‘applicable water quality 

standards’’ (in the 1970 version) to ‘‘the applicable 

provisions of sections 301, 302, 306, and 307’’ of 

the 1972 CWA. Congress amended section 401 in 

this way to reflect its new strategy to more 

effectively advance water quality protection and 

improvement; it is difficult to see why it would, at 

the same time, significantly narrow the scope of 

certification so as to undermine its power and 

effectiveness. 

further support for a scope of review 

encompassing the activity subject to the 

Federal license or permit, not just its 

discharges. Section 401(a)(1) provides 

that ‘‘[i]n the case of any such activity 

for which there is not an applicable 

[water quality requirement,59] the State 

shall so certify . . .’’ 33 U.S.C 1341(a)(1) 

(emphasis added).60 This final rule 

interprets this language to mean that if 

the certifying authority determines that 

no water quality requirements are 

applicable to the activity, the certifying 

authority shall grant certification. 40 

CFR 121.7(g). Important to interpreting 

scope, what matters for this provision is 

whether there are water quality 

requirements applicable to the 

‘‘activity,’’ not the ‘‘discharge.’’ 

Congress added this provision in the 

same 1972 act that changed ‘‘activity’’ to 

‘‘discharge’’ earlier in section 401(a)(1). 

Yet Congress used ‘‘activity’’ here. 

Congress’s use of ‘‘activity’’ in this 

provision of section 401(a)(1) instead of 

‘‘discharge’’ adds further support to the 

conclusion that Congress intended for 

the scope of certification to encompass 

the activity subject to the Federal 

license or permit, not just its discharges. 

Section 401(a)(3)–(5) adds more 

support.61 Section 401(a)(3) provides 

that a certification for the 

‘‘construction’’ of a ‘‘facility’’ fulfills the 

section 401 obligations with respect to 

the facility’s ‘‘operation’’ unless the 

certifying authority determines there is 

no longer reasonable assurance of 

compliance with water quality 

requirements. See 33 U.S.C. 1341(a)(3). 

‘‘Construction’’ and ‘‘operation’’ of a 

‘‘facility’’ are clearly broader concepts 

than ‘‘discharge.’’ In addition, section 

401(a)(4) allows the certifying authority 

the opportunity to ‘‘review the manner 

in which the [previously certified] 

facility or activity shall be operated or 

conducted’’ prior to initial operation for 

the purpose of assuring this will not 

violate applicable water quality 

requirements. See id. at 1341(a)(4). 

Reviewing how the ‘‘facility or activity’’ 

is ‘‘operated or conducted’’ goes well 

beyond simply evaluating any related 

‘‘discharge.’’ Continuing with this 

language, Congress provided that if this 

review results in suspension of the 

facility or activity’s Federal license or 

permit, the license or permit remains 

suspended until notification from the 

certifying authority that there is 

reasonable assurance that ‘‘such facility 

or activity’’—not discharge—‘‘will not 

violate’’ water quality requirements. Id. 

Lastly, section 401(a)(5) provides that 

any certified Federal license or permit 

may be suspended or revoked by the 

Federal licensing or permitting agency 

upon an entry of judgment that ‘‘such 

facility or activity,’’ not discharge, has 

been operated in violation of applicable 

water quality requirements. See id. at 

1341(a)(5). The scope of review 

employed in each of these subsections 

is whether there has been compliance 

by the ‘‘facility or activity’’ with the five 

CWA sections identified in section 

401(a)(1) (i.e., CWA sections 301, 302, 

303, 306, and 307), and not merely 

compliance by the ‘‘discharge.’’ 

Congress’s choice to use broad words 

such as ‘‘facility’’ and ‘‘activity,’’ rather 

than the narrower ‘‘discharge,’’ to 

describe what is subject to the 

substantive requirements in section 

401(a)(3)–(5) should be given meaning 

and is in this final rule. For a discussion 

on the text of section 401(a)(2), see 

section IV.K of this preamble, infra. 

iii. Legislative History Confirms 

Congress Intended an Activity-Based 

Scope 

The legislative history of CWA section 

401, and of its predecessor section 21(b) 

of the Water Quality Improvement Act 

of 1970 where the certification 

requirement was first enacted, provides 

persuasive evidence that Congress 

intended the scope of certification to 

include the activity subject to the 

Federal license or permit, not only its 

point source discharges. As discussed in 

section III of this preamble, Congress 

significantly revised 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 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 

below the legislative history of the 1972 

CWA amendments demonstrates that 

these changes were not intended to 

significantly narrow the scope of section 

401, contrary to what some commenters 

argued and what EPA stated in its 

justification for the 2020 Rule. 

The pre-1972 version of section 401 

indisputably authorized certifying 

authorities to review the entire activity, 

not only its point source discharges. 

Congress originally enacted the water 

quality certification requirement in 

section 21(b) of the Water Quality 

Improvement Act of 1970. Public Law 

91–224, 84 Stat. 91 (April 3, 1970). That 

section provided that any applicant for 

a Federal license or permit to conduct 

any activity including, but not limited 

to, the construction and operation of 

facilities, which may result in any 

discharge into the navigable waters of 

the United States, ‘‘shall provide the 

licensing or permitting agency a 

certification from the State in which the 

discharge originates or will originate 

. . . that there is reasonable assurance 

. . . that such activity will be conducted 

in a manner which will not violate 

applicable water quality standards.’’ 

Public Law 91–224, 21(b)(1), 84 Stat. 91 

(April 3, 1970) (emphasis added). Had 

this language remained untouched, 

there would be no question regarding 

congressional intent; the 1970 language 

clearly envisioned a broad ‘‘activity’’ 

scope of certification. 

However, in 1972, Congress changed 

the above italicized language to ‘‘such 

discharge will comply with the 

applicable provisions of sections 301, 

302, 306, and 307 of this Act.’’ Public 

Law 92–500, 401(a)(1), 86 Stat. 816 (Oct. 

18, 1972). While Congress changed the 

word ‘‘activity’’ to ‘‘discharge’’ in this 

one instance when overhauling the 

CWA in 1972, the rest of the legislative 

history of the 1972 amendments 

demonstrates that Congress did not 

intend this one edit to section 401(a)(1) 

to dramatically narrow the scope of 

certification.62 First, as discussed above, 

Congress made other revisions in 1972 

that demonstrate Congress’s intent to 


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63 Indeed, the 1971 Senate Report provided that 

section 401 was ‘‘amended to assure consistency 

with the bill’s changed emphasis from water quality 

standards to effluent limitations based on the 

elimination of any discharge of pollutants.’’ S. Rep. 

No. 92–414, at 69 (1971). 

64Congress’s revisions to section 401 in the 1977 

CWA amendments also suggest continued support 

for a broader ‘‘activity’’ approach. As discussed 

more fully in section E.2.c below, in 1977, Congress 

made further minor changes to section 401, this 

time inserting section 303 into the list of CWA 

sections for which a state must certify compliance. 

In the legislative history, Congress explained this 

‘‘means that a federally licensed or permitted 

activity, including discharge permits under section 

402, must be certified to comply with State water 

quality standards adopted under section 303.’’ H.R. 

Rep. No. 95–830, at 96 (1977) (emphasis added). 

retain a broader activity-based scope. 

Congress used the phrase ‘‘such 

activity’’ (instead of ‘‘such discharge’’) 

in the very next sentence of section 

401(a)(1) and added section 401(d), 

which authorizes certification 

conditions that assure that ‘‘any 

applicant’’ (instead of ‘‘any discharge) 

will comply with water quality 

requirements. The broad phrasing in 

section 401(a)(3)–(5) existed in section 

21(b) and, tellingly, was not revised by 

Congress in 1972. Further, the 

legislative record shows that, in 1972, 

Congress understood it was making only 

‘‘minor,’’ insubstantial changes to 

section 21(b) to harmonize with the 

substantial new provisions of the CWA 

pertaining to regulation of point source 

discharges.63 The Senate Report stated 

that section 401 was ‘‘substantially 

section 21(b) of the existing law.’’ S. 

Rep. No. 92–414, at 69 (1971); see also 

remarks of Sen. Baker: ‘‘Section 21(b), 

with minor changes, appears as section 

401 of the pending bill S.2770.’’ 117 

Cong. Rec. 38857 (1971). Nowhere in 

the legislative history is there a 

statement to the effect that Congress 

intended to dramatically shrink section 

401’s scope of review and protection to 

only those water quality effects caused 

by a potential point source discharge. 

To the contrary, the House Report stated 

that ‘‘[i]t should be clearly noted that 

the certifications required by section 

401 are for activities which may result 

in any discharge into navigable waters.’’ 

H.R. Rep. 92–911, at 124 (1972) 

(emphasis added). Indeed, in 

summarizing section 401, Senator 

Muskie stated that ‘‘[a]ll we ask is that 

activities that threaten to pollute the 

environment be subjected to the 

examination of the environmental 

improvement agency of the State for an 

evaluation and recommendation before 

the Federal license or permit be 

granted.’’ 117 Cong. Rec. 38854 (1971) 

(emphasis added). See also H.R. Rep. 

92–911, at 121 (1972) (stating that ‘‘[t]he 

term ‘applicable’ as used in section 401 

. . . means that the requirement which 

the term ‘applicable’ refers to must be 

pertinent and apply to the activity 

. . . .’’) (emphasis added). In light of 

the lack of any compelling evidence in 

the legislative history that Congress 

intended to fundamentally constrain the 

certification power it granted just two 

years before, and the abundant evidence 

to the contrary, EPA adopts the full 

activity scope of review included in the 

proposed rule.64

iv. Response to Comments Regarding an 

Activity-Based Scope of Certification 

The Agency received numerous 

comments on the proposed return to an 

activity-based scope of certification 

review, including comments about the 

statutory language, legislative history, 

PUD No. 1, and the water quality harms 

associated with the 2020 Rule. This 

subsection contains summaries of these 

comments and the Agency’s response. 

Comment summaries and additional 

discussion of other aspects of scope of 

certification (i.e., defining the ‘‘activity’’ 

subject to certification, water quality 

requirements, waters considered in 

acting on a request for certification, and 

scope of conditions) are included 

elsewhere in this section of the 

preamble. 

A. Comments Regarding the Language 

in Section 401 

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. While the statutory 

text lends itself to more than one 

conceivable interpretation, the 

interpretation adopted in this final rule 

is the best reading of the text and 

follows the Supreme Court’s 

authoritative interpretation in PUD No. 

1. Some commenters asserted that the 

text of section 401 dictates a single 

interpretation of scope, although those 

commenters disagreed on that 

interpretation. A few such 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. Conversely, other 

commenters argued that the statutory 

language of section 401 unambiguously 

provides for certification on all aspects 

of the applicant’s activity subject to the 

Federal license or permit, not only its 

potential point source discharges. A few 

of these commenters argued that the 

Court’s holding in PUD No. 1 was based 

on the unambiguous language of the 

statute. 

EPA disagrees with both sets of 

commenters. Although the Supreme 

Court’s 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’’ as pertaining to 

the activity, 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.’’). 

Congress’s 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. 

B. Comments Regarding Statutory 

Interpretation 

Some commenters asserted that EPA 

misconstrued section 401(d), often 

reasserting arguments made in the 

preamble to the 2020 Rule or the 

dissenting opinion in PUD No 1. Some 

commenters echoed arguments made by 

the dissenting opinion in PUD No. 1 

that section 401(a)(1) limits a certifying 

authority to ‘‘ensuring that any 

discharge resulting from a project will 

comply’’ with water quality 

requirements and therefore, ‘‘while 

§ 401(d) permits a State to place 

conditions on a certification to ensure 

compliance of the ‘applicant,’ those 

conditions must still be related to 

discharges.’’ 511 U.S. at 726 (Thomas, J., 

dissenting). Other commenters similarly 

argued that the reference in section 

401(d) to ‘‘applicant’’ merely indicates 

who must comply with certification 

conditions. These comments are similar 

to the position taken in the 2020 Rule 

that ‘‘the term ‘applicant’ in section 

401(d) [was] merely identifying the 


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person or entity responsible for 

obtaining and complying with the 

certification and any associated 

conditions and not as expanding the 

regulatory scope of that section.’’ 85 FR 

42232. 

EPA disagrees with the arguments 

made by these commenters, the dissent 

in PUD No. 1, and the preamble to the 

2020 Rule. First, Congress could easily 

have used the term ‘‘discharge’’ in 

section 401(d) in place of ‘‘applicant’’ 

and chose not to. Congress used similar 

phrasing in other parts of the CWA. For 

example, CWA section 402 

contemplates that an NPDES permit 

may issue only upon a showing that a 

‘‘discharge will meet’’ various 

enumerated provisions. 33 U.S.C. 

1342(a). In fact, Congress used this very 

phrasing in section 401(a)(1)—requiring 

certification that ‘‘any such discharge 

will comply.’’ Id. at 1341(a)(1) 

(emphasis added). It is Congress’s use of 

these different phrases in section 

401(a)(1) and section 401(d) that led the 

Supreme Court to decide the issue in 

PUD No. 1 and now requires the Agency 

to interpret the proper scope of 

certification. Congress added section 

401(d) in the same legislation in which 

it revised section 401(a)(1) to refer to 

‘‘discharge.’’ Congress could have used 

the same term in section 401(d) but it 

did not. EPA’s interpretation of section 

401(d) accounts for these 

considerations. Transbrasil, 791 F.2d at 

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.’’). 

EPA disagrees with the commenters 

that suggested that section 401(d) is 

irrelevant to the scope of certification. 

Section 401(d) requires the certifying 

authority—when making a decision to 

certify under section 401(a)(1)—to 

include conditions necessary to assure 

that the license or permit applicant will 

comply with water quality 

requirements, including applicable 

requirements of state law listed only in 

section 401(d). As the Court in PUD No. 

1 recognized, section 401(d) is central to 

interpreting the scope of section 401. 

511 U.S. at 711–712 (analyzing both 

section 401(a)(1) and section 401(d) to 

interpret scope). Following this 

approach, this final rule adopts the 

interpretation of section 401 that, when 

read as a whole, best aligns with the 

language Congress chose for section 

401(a)(1) and section 401(d), not just the 

language of section 401(a)(1). 

C. Comments on Legislative History 

Some commenters asserted that 

Congress’s 1972 revisions to section 

401(a)(1) support a ‘‘discharge-only’’ 

approach. These commenters argued 

that, when Congress revised ‘‘such 

activity’’ to ‘‘such discharge,’’ Congress 

unambiguously limited the scope of 

certification to the ‘‘discharge,’’ rather 

than the ‘‘activity.’’ EPA disagrees that 

the better interpretation of the 1972 

revisions is that Congress intended to 

narrow the scope of certification. That 

interpretation considers only a portion 

of the 1972 amendments. It does not 

grapple with how to reconcile the 

revisions to section 401(a)(1) with the 

addition of section 401(d), which 

broadly authorizes certifying authorities 

to condition certification decisions— 

made under section 401(a)(1)—to assure 

that the ‘‘applicant’’ complies with 

water quality requirements. It also does 

not grapple with the use by the 1972 

amendments of ‘‘such activity’’ later in 

section 401(a)(1), regarding activities 

without applicable water quality 

requirements. When Congress added 

section 401(d) and added the new 

sentence to section 401(a)(1) regarding 

activities without applicable water 

quality requirements, Congress could 

have used the term ‘‘discharge’’ but 

chose not to do so. EPA’s interpretation 

of section 401’s scope must account for 

that choice. Moreover, the commenter’s 

interpretation does not harmonize with 

the extensive legislative history 

suggesting that Congress had no 

intention of substantially narrowing the 

certification power it had previously 

granted to states. See section IV.E.2.a.iii 

of this preamble, supra. 

A couple of commenters asserted that 

Congress’s revised certification language 

reflected a new emphasis in the CWA 

on directly regulating point source 

discharges of pollutants, away from 

indirectly regulating activities through 

ambient water quality standards. The 

preamble to the 2020 Rule made a 

similar point, that the 1972 amendments 

to section 401 made it ‘‘consistent with 

the overall framework of the amended 

statutory regime, which focuses on 

regulating discharges to attain water 

quality standards and adds new federal 

regulatory programs to achieve that 

purpose.’’ 85 FR 42232. 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 dischargerelated 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. As 

discussed directly above at section 

IV.E.2.a.iii of this preamble, the 

legislative history shows that when 

Congress was enacting new dischargerelated permitting provisions in 1972, it 

had no intention of fundamentally 

constraining the certification power that 

Congress granted just two years before. 

D. Comments Regarding PUD No. 1 

A few commenters asserted that the 

Court in PUD No. 1 relied on, and 

deferred to, EPA’s 1971 Rule and 

guidance derived from that rule. One 

commenter asserted that the PUD No. 1 

decision was based on judicial 

deference to EPA regulations that 

predated the 1972 CWA amendments 

and should be distinguished on this 

basis. Another commenter asserted that 

the Court’s reliance on the 1971 Rule 

significantly undermines the validity 

and applicability of the PUD No. 1 

decision for this rulemaking. Similar to 

these commenters, the dissenting 

opinion in PUD No. 1 also asserted that 

the majority relied ‘‘at least in part’’ on 

the 1971 Rule. 511 U.S. at 728–29 

(Thomas, J., dissenting). 

EPA first notes that the Court did not 

rely on EPA’s 1971 Rule during the 

Court’s own analysis of the statutory 

text. The Court first undertook its own 

examination of the statutory text, 

concluding that section 401(d) ‘‘is most 

reasonably read’’ as authorizing 

conditions on the entire activity at 

issue. Id. at 712. Only after reaching that 

conclusion did the Court note that 

‘‘[o]ur view of the statute is consistent 

with EPA’s regulations implementing 

§ 401.’’ Id. Therefore, EPA disagrees 

with commenters that asserted that the 

Court’s analysis of the statutory text 

relied on the 1971 Rule. EPA also 

disagrees with commenters that the 

Court’s discussion of the 1971 Rule 

undermines the applicability of PUD 

No. 1 for this rulemaking. As described 

above, EPA is not concluding that the 

proper scope of certification is the 

activity subject to the Federal license or 

permit solely because that was the 

Supreme Court’s holding in PUD No. 1, 

although the Court’s authoritative 

holding on the issue offers compelling 

support. Instead, EPA has 

independently reviewed the statutory 

text, and agrees with the Court’s 

analysis of section 401(a)(1) and section 

401(d). EPA finds further support for its 

conclusion in additional statutory text 

of section 401 beyond what the Court 

analyzed in PUD No. 1, the legislative 


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65See also Economic Analysis for the Final Rule 

at section 4.5 for further discussion on the 

environmental benefits and incremental costs 

associated with the final rule as compared to the 

2020 Rule baseline. 

history of section 401, the water quality 

protection goals of section 401, and the 

principles of cooperative federalism that 

underlie the CWA—particularly section 

401 itself. 

E. Comments Regarding Water Quality 

Harms of 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. For example, 

one commenter argued that the 2020 

Rule’s narrower ‘‘discharge-only’’ 

approach to section 401 prohibited 

states and Tribes from considering 

activities 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. One 

commenter argued that activities 

directly adjacent to streams and 

wetlands have a direct relationship to 

the biological, physical, and chemical 

components and overall health of the 

water resource. Another commenter 

asserted that without the ability to 

consider the entire activity subject to 

certification, states and Tribes would 

underestimate the implications of 

projects on watershed scales and lose 

capacity to manage designated uses. 

Several commenters specifically 

discussed the importance of an activitybased scope for hydroelectric dam 

projects. One commenter asserted that 

review under the 2020 Rule left water 

quality impacts from a dam 

unmitigated, including a change in the 

timing and flow of water, blockage of 

nutrients, and altered chemical makeup 

of the water due to reservoirs. Similarly, 

another commenter provided additional 

examples of the water quality impacts 

from hydroelectric dams that are not 

tied to a specific discharge and therefore 

left out under the 2020 Rule, including 

increased water temperature from 

decreased water flows, vegetation loss 

and reduced shading from dam 

reservoirs, fish kills from turbines, and 

increased toxin mobility from elevated 

turbidity. A different commenter 

asserted that the discharge from the 

powerhouse or tailrace of FERC-licensed 

hydropower projects is not the only 

impact from those projects, but rather 

the entire project fundamentally alters 

the chemical, physical, and biological 

integrity of a river. 

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. For example, 

when looking at a hydropower project, 

the ‘‘activity’’ scope allows a certifying 

authority to consider water qualityrelated impacts beyond the discharges 

from the tailrace or powerhouse. 

Depending on the activity specifics, 

such consideration could result in 

certification conditions that could 

include building or maintaining fish 

passage or habitat restoration related to 

water quality protection. As another 

example, when reviewing the 

construction of a pipeline project, the 

‘‘activity’’ scope allows a certifying 

authority to consider water qualityrelated impacts beyond the discharge of 

dredge or fill material from the 

construction and placement of the 

pipeline and, depending on the activity 

specifics, can include water quality 

impacts from non-discharge related 

erosion or sedimentation from the 

pipeline construction, as well as later 

water quality impacts from erosion or 

sedimentation from the operation and 

maintenance of the pipeline. Certifying 

authorities can consider certification 

conditions that include monitoring, 

reporting, and adaptive management in 

response to the non-discharge-related 

water quality impacts of the activity, 

such as temperature, flow, riparian 

buffer conditions, and species 

impacts.65 As another example, when 

reviewing the construction of a boat 

marina, the ‘‘activity’’ scope allows a 

certifying authority to consider not only 

the discharges associated with dredging 

and placement of fill for the marina, but 

also, depending on the activity 

specifics, erosion or sedimentation 

related to construction of the marina, as 

well as water quality impacts related to 

the subsequent operation of the marina 

(e.g., increased vessel pollution in the 

water associated with increased vessel 

traffic due to the construction of the 

dock). See section IV.E.2.b of this 

preamble, directly infra, regarding what 

is included as part of the ‘‘activity’’ 

subject to certification. The inability of 

states and authorized Tribes to protect 

against such impacts under the 2020 

Rule could seriously impair their ability 

to protect valuable water resources. This 

would be inconsistent with Congress’s 

intention to provide states and 

authorized Tribes with a powerful tool 

to prevent their water resources from 

being adversely impacted by projects 

needing Federal licenses or permits. 

b. Defining the ‘‘Activity’’ Subject to 

Certification 

As discussed above, the Agency is 

revising § 121.3 regarding scope of 

certification to clarify that a certifying 

authority’s evaluation is limited to the 

water quality related-impacts from the 

activity subject to the Federal license or 

permit. This is the best interpretation of 

the statutory language and is consistent 

with congressional intent, the Agency’s 

longstanding interpretation prior to the 

2020 Rule, and PUD No. 1. Although 

this reading had been the Agency’s 

longstanding interpretation prior to the 

2020 Rule and should be familiar to 

stakeholders, in response to comments 

and to aid in implementation of this 

final rule, the Agency is providing 

further clarification around the 

‘‘activity’’ subject to certification. 

The Agency proposed a definition of 

the term ‘‘activity as a whole’’ at 

§ 121.1(a). In this final rule, the Agency 

is removing the phrase ‘‘as a whole’’ 

from the regulatory text throughout part 

121. Although the Supreme Court used 

the phrase ‘‘as a whole’’ in PUD No. 1, 

511 U.S. at 712, the phrase is not found 

in the statutory text. This modification 

does not represent a change in 

substance from proposal. The Agency 

does not interpret the terms ‘‘activity’’ 

and ‘‘activity as a whole’’ as having 

different meanings; rather, EPA 

included the phrase ‘‘as a whole’’ in the 

proposed rule simply to emphasize that 

a certifying authority’s evaluation 

extends to the activity in its entirety, as 

opposed to just the point source 

discharges associated with the activity. 

EPA concludes that the final regulatory 

text at § 121.3 makes this clear without 

the need to add ‘‘as a whole.’’ The 

Agency has historically used the word 

‘‘activity’’ to refer to the scope of 

certification. See, e.g., 1989 Guidance at 

8 (‘‘If a State grants water quality 

certification to an applicant for a federal 

license or permit, it is in effect saying 

that the proposed activity will comply 

with State water quality standards (and 

the other CWA and State law provisions 

enumerated above).’’), 23 (‘‘all of the 

potential effects of a proposed activity 

on water quality—direct and indirect, 

short and long term, upstream and 

downstream, construction and 


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operations—should be part of a State’s 

certification review.’’); 2010 Handbook 

at 10 (rescinded in 2019, see supra) 

(‘‘The granting of § 401 water quality 

certification to an applicant for a federal 

license or permit signifies that the state 

or tribe has determined that the 

proposed activity and discharge will 

comply with water quality standards as 

well as the other identified provisions of 

the CWA and appropriate requirements 

of state or tribal law.’’). The Court in 

PUD No. 1 appeared to use the terms 

‘‘activity as a whole,’’ ‘‘activity,’’ and 

even ‘‘project in general’’ 

interchangeably. PUD No. 1, 511 U.S. at 

711–12. Accordingly, the Agency is 

removing the phrase ‘‘as a whole’’ to 

better reflect the statutory text and to 

reduce any confusion that this phrase 

caused commenters. 

The Agency proposed at § 121.1(a) to 

define the term ‘‘activity as a whole’’ to 

capture ‘‘any aspect of the project 

activity with the potential to affect 

water quality.’’ EPA intended for this 

proposed definition to provide 

certifying authorities with the ability to 

consider any aspect of the federally 

licensed or permitted activity that may 

adversely impact water quality. The 

impacts of a federally licensed or 

permitted project on a certifying 

authority’s water resources may be 

caused by aspects of the project’s 

activity other than the potential 

discharge that triggered the need for a 

section 401 certification (e.g., nondischarge impacts from the construction 

and operation of the project). The 

Agency’s proposed definition for the 

term ‘‘activity as a whole’’ was meant to 

include all aspects of the proponent’s 

‘‘project in general’’ with the potential 

to affect water quality. PUD No. 1, 511 

U.S. at 711. Many commenters asserted 

that the proposed definition was 

ambiguous, confusing, and circular. In 

light of commenter concerns and in the 

interest of greater clarity, the Agency is 

not finalizing the proposed definition 

for ‘‘activity as a whole,’’ and instead 

will rely on clarifying edits in final rule 

§ 121.3 to articulate the activity subject 

to a certifying authority’s review. 

Consistent with its proposal, 87 FR 

35345, the Agency finds that section 401 

is not constrained to those activities 

directly authorized by the Federal 

license or permit in question. Section 

401(a)(3) provides compelling textual 

support for this reading. Specifically, 

section 401(a)(3) makes clear that a 

certification for a Federal license or 

permit for construction may address 

potential water quality impacts from the 

subsequent operation even though the 

operation may be subject to a different 

Federal license or permit. 33 U.S.C. 

1341(a)(3) (‘‘The certification . . . with 

respect to the construction of any 

facility shall fulfill the requirements of 

this subsection with respect to 

certification in connection with any 

other Federal license or permit required 

for the operation of such facility’’ except 

in the circumstances described in 

section 401(a)(3)). By providing that a 

construction permit certification shall 

also serve as an operating permit 

certification (unless notice is given of 

changes which call into question 

whether the operation will in fact 

comply with water quality 

requirements), section 401(a)(3) 

necessarily contemplates that the 

certification of the construction permit 

will have considered whether the 

subsequent operation will comply with 

water quality requirements. 

EPA finds additional support for this 

interpretation in section 401(a)(4). That 

provision authorizes a certifying 

authority, after it has granted 

certification for a facility or activity, to 

review, prior to its initial operation, the 

manner in which a facility or activity 

will be operated if the ‘‘facility or 

activity is not subject to a Federal 

operating license or permit.’’ 33 U.S.C. 

1341(a)(4). If the certifying authority has 

already granted certification and the 

facility or activity is not subject to a 

Federal operating license or permit, by 

implication the certifying authority has 

certified a pre-operational Federal 

license or permit such as a construction 

permit. Yet section 401(a)(4) tasks a 

certifying authority that has certified a 

construction permit with reviewing the 

subsequent operation ‘‘for the purposes 

of assuring’’ that ‘‘the manner in which 

the facility or activity shall be operated 

or conducted’’ will not violate water 

quality requirements. Id. (emphasis 

added). For this reason, section 

401(a)(4) adds further support to EPA’s 

conclusion that section 401 is best read 

to authorize a certifying authority to 

consider all aspects of the activity, not 

only those directly authorized by the 

relevant Federal license or permit at 

hand. 

This interpretation is consistent with 

EPA’s longstanding position before the 

2020 Rule. Previously issued EPA 

guidance provided that ‘‘because the 

States’ certification of a construction 

permit or license also operates as 

certification for an operating permit 

(except for in certain instances specified 

in Section 401(a)(3)), it is imperative for 

a State review to consider all potential 

water quality impacts of the project, 

both direct and indirect, over the life of 

the project.’’ 1989 Guidance at 22; 2010 

Handbook at 17 (rescinded in 2019, see 

supra) (‘‘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.’’) 

(citing PUD No. 1, 511 U.S. at 712 

(1994)). Additionally, the Agency issued 

a memorandum in 1985 discussing a 

question from a certifying authority 

about whether a certification for a 

section 404 permit for the construction 

of a marina could consider the 

subsequent operation of the marina. 

Winer Memorandum. The Agency 

concluded, based largely on its reading 

of section 401(a)(3), that when acting on 

a request for certification for a section 

404 permit for the construction of a 

marina, the certifying authority will 

have considered water quality impacts 

resulting from the subsequent operation 

of the marina. 

The legislative history offers 

additional support for this 

interpretation. The legislative history 

reveals Congress’s intent to ensure that 

federally licensed or permitted activities 

are not considered in a piecemeal 

fashion; rather, Congress recognized the 

importance of considering the effects of 

subsequent operations during site 

selection, see S. Rep. No. 91–351, at 8 

(August 7, 1969) (‘‘Site location is 

integral to effective implementation of 

the Nation’s water quality program. 

There are sites where no facility should 

be constructed, because pollution 

control technology is not adequate to 

assure maintenance and enhancement of 

water quality. Those who make the 

decision on site location should be 

aware of this prior to making any 

investment in new facilities.’’), and of 

early planning to avoid later adverse 

effects, see H.R. Rep. 91–127, at 6 

(March 25, 1969) (‘‘The purpose of 

subsection 11(b) is to provide 

reasonable assurance . . . that no 

license or permit will be issued by a 

Federal agency for an activity that 

through inadequate planning or 

otherwise could in fact become a source 

of pollution.’’). After reviewing 

comments that the Agency requested on 

the issue, EPA concludes that section 

401 is best read to authorize a certifying 

authority to consider all aspects of the 

activity, not only those directly 

authorized by the relevant Federal 

license or permit. 

Accordingly, the revised text at final 

rule § 121.3 indicates that a certifying 

authority shall evaluate the water 

quality-related impacts of the entire 

activity subject to the Federal license or 

permit, including the construction and 

operation, and not solely the aspect of 

the activity directly authorized by a 

given Federal license or permit. For 

example, a section 401 certification on 


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a CWA section 404 permit authorizing 

the discharge of dredge or fill material 

in waters of the United States may 

consider both the construction 

associated with dredging (e.g., removing 

sediment from the waterbody to place 

dock pilings) as well as the subsequent 

operation associated with the 

completion of the dredging (e.g., 

increased vessel pollution in the water 

associated with increased vessel traffic 

due to the construction of the dock). 

EPA requested comment on 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. One commenter asserted 

that the bounds of the permitting 

authority of the Federal permitting 

agency cannot dictate the scope of state 

or Tribal authority under section 401, 

observing that section 401(d) requires 

the Federal agency to incorporate into 

the Federal license or permit those 

certification conditions the state or 

authorized Tribe includes to ensure 

compliance with water quality 

requirements. EPA generally agrees with 

this commenter. 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. 

A few commenters asserted that the 

definition for ‘‘activity as a whole’’ 

could be used by certifying authorities 

to impose conditions on activities that 

may only be speculatively or obscurely 

linked to the actual discharge. In 

addition, 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. 

In response to comments, 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 § 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). Consistent with the intent of 

the proposed rule, § 121.3 in the final 

rule clearly limits a certifying 

authority’s analysis of any given activity 

to adverse water quality-related impacts 

that may prevent compliance with water 

quality requirements. As discussed 

below, 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 water quality requirements; only if 

the activity will not comply with such 

requirements, does section 401 

authorize certifying authorities to either 

condition the activity in such way to 

ensure compliance or deny the activity 

where compliance cannot be ensured 

with conditions. Accordingly, section 

401 and this final rule do not authorize 

certifying authorities to deny or 

condition a certification due to impacts 

from the activity that do not adversely 

affect water quality. However, the 

Agency wishes to make clear that 

certifying authorities may address not 

only adverse water quality impacts 

caused exclusively by the federally 

licensed or permitted activity, but also 

adverse impacts contributed to by a 

federally licensed or permitted activity. 

For example, a certifying authority may 

deny or condition an activity that will 

contribute to ongoing noncompliance 

with water quality requirements. 

Relatedly, section 401 and this final rule 

do not authorize a certifying authority to 

condition an activity for the purpose of 

protecting waters that are not impacted 

by the activity or include conditions 

that do not otherwise affect compliance 

with the applicable water quality 

requirements in the waters impacted by 

the activity. 

The 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. The Agency 

encourages certifying authorities to 

clearly state in a certification decision 

why a condition is necessary to assure 

that the activity will comply with water 

quality requirements or, in a denial, 

why it cannot certify that the activity 

will comply with water quality 

requirements. See 40 CFR 121.7; see 

also infra section IV.F of this preamble. 

If the project proponent believes the 

certification decision is premised on, in 

the words of one commenter, a 

‘‘statistically insignificant aspect of the 

project,’’ it may challenge the 

sufficiency of the decision in a court of 

competent jurisdiction. If a project 

proponent believes a certification 

decision is based on unreasonable 

conclusions regarding the water qualityrelated 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). 

One commenter argued that the 

Agency had not adequately explained 

how the ‘‘activity as a whole’’ scope 

would function in practice, and, as a 

result, the definition would introduce 

regulatory uncertainty, pose litigation 

risk regarding certification decisions, 

and threaten infrastructure projects. The 

Agency disagrees. 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 


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66 It is also consistent with EPA’s interpretation 

in the 1971 Rule regarding section 21(b) in the 

Water Quality Improvement Act of 1970 (the 

precursor to current section 401). See, e.g., 40 CFR 

121.2(a)(3) (2019) (certification decisions concern 

whether ‘‘the activity will be conducted in a 

manner which will not violate applicable water 

quality standards’’). 

‘‘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 

supra for further discussion. 

c. Water Quality Requirements 

As proposed, EPA is finalizing the 

definition of water quality requirements 

as ‘‘any limitation, standard, or other 

requirement under sections 301, 302, 

303, 306, and 307 of the Clean Water 

Act, any Federal and state or Tribal laws 

or regulations implementing those 

sections, and any other water qualityrelated requirement of state or Tribal 

law.’’ 40 CFR 121.1(j). The final rule 

definition is consistent with 

congressional intent as well as longstanding Agency interpretation of the 

CWA. A fundamental factor in the scope 

of a section 401 certification is that the 

certifying authority is limited to 

considering whether the activity will 

comply with applicable water quality 

requirements. See 33 U.S.C. 1341(a), (d). 

This serves as a key limitation on the 

otherwise broad authority granted by 

Congress to certifying authorities. As 

discussed in more detail below, this 

approach was supported by the 

overwhelming majority of commenters 

on the proposed rule. 

i. Water Quality-Related Impacts From 

Federally Licensed or Permitted Projects 

EPA is finalizing that when a 

certifying authority reviews a request for 

certification, ‘‘[t]he certifying authority’s 

evaluation is limited to the water 

quality-related impacts from the activity 

subject to the Federal license or permit, 

including the activity’s construction and 

operation.’’ 40 CFR 121.3(a) (emphasis 

added). This limitation to evaluating 

water quality-related impacts was 

included in EPA’s proposed definition 

of ‘‘activity as a whole’’—‘‘any aspect of 

the project activity with the potential to 

affect water quality’’—and EPA’s 

proposal was clear that section 401 is 

limited to addressing only water 

quality-related impacts. 87 FR 35343. 

The CWA’s overall objective is ‘‘to 

restore and maintain the chemical, 

physical, and biological integrity of the 

Nation’s waters.’’ 33 U.S.C. 1251(a). 

Among the Act’s policy declarations is 

‘‘the policy of Congress to recognize, 

preserve, and protect the primary 

responsibilities of States to prevent, 

reduce, and eliminate pollution.’’ Id. at 

1251(b). 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 key limiting principle to that 

otherwise broad authority—the review 

is limited to determining compliance 

with water quality requirements. From 

its first inclusion of then-section 21(b) 

in the Water Quality Improvement Act 

of 1970, Congress intended to provide 

states and Tribes with a powerful tool 

to prevent their water resources from 

being adversely impacted by projects 

needing Federal licenses or permits. See 

116 Cong. Rep. 8805, 8984 (March 24, 

1970) (‘‘Mr. Muskie: No polluter will be 

able to hide behind a Federal license or 

permit as an excuse for a violation of 

water quality standard.’’). Although 

Congress has changed the words and 

phrases that convey that limitation, 

legislative history shows consistent 

congressional intent over time. See, e.g., 

S. Rep. 92–414, at 1487 (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.’’). In short, Congress 

intended section 401 to provide 

certifying authorities with broad 

authority with respect to protecting 

water quality within their jurisdiction 

but specifically confined that authority 

to water quality. 

Judicial and EPA interpretation on 

this point also have remained constant. 

The courts have consistently agreed that 

certifying authorities are limited to 

considering water quality effects. See 

PUD No. 1, 511 U.S. at 711–713 

(holding that a state’s authority to 

impose conditions under section 401(d) 

‘‘is not unbounded’’); see also Am. 

Rivers, Inc. 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.’’). The same 

is true for prior Agency interpretations, 

as articulated in the 2020 Rule and in 

prior Agency guidance. See 85 FR 

42250; 1989 Guidance at 22 (‘‘[I]t is 

imperative for a State review to consider 

all potential water quality impacts of the 

project, both direct and indirect, over 

the life of the project.’’).66

The overwhelming majority of 

commenters agreed that the scope of 

section 401 certification is limited to 

water quality. Accordingly, 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 qualityrelated 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). 

Several commenters asserted that 

certifying authorities considered nonwater quality-related factors prior to the 

2020 Rule and provided examples of 

such factors and the consequences, 

including project delays, ambiguity, and 

undue burdens on project proponents. A 

few commenters asserted that a handful 

of states have attempted to block or 

constrain projects based on non-water 

quality-related reasons and discussed 

specific certification actions as ‘‘state 

abuse’’ of section 401. Based on 

commenter feedback and EPA’s 

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 § 121.1(j), 121.3. 

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. These commenters argued that 

the proposed rule would allow states to 

block projects for non-water quality 

reasons, which the commenters asserted 

include effects on designated uses of a 

water body that are not associated with 

water quality changes (e.g., changes in 

water flow that might affect aquatic 

habitat). 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 


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chemical, physical, and biological 

integrity of waters, which could 

include, for example, changes in water 

flow that might affect aquatic habitat. 

EPA has consistently interpreted water 

quality impacts broadly. See, e.g., 1989 

Guidance at 22 (‘‘all of the potential 

effects of a proposed activity on water 

quality—direct and indirect, short and 

long term, upstream and downstream, 

construction and operation—should be 

part of a State’s certification review’’); 

2010 Handbook at 17 (rescinded in 

2019, see supra) (‘‘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’’). In 1991, EPA sent a letter to 

FERC in response to various FERC 

documents discussing ‘‘inappropriate’’ 

section 401 certification conditions, 

including conditions related to fish, 

wildlife, vegetation, and recreation. 

Letter from LaJuana S. Wilcher, 

Assistant Administrator of the Office of 

Water, to Lois D. Cashell, FERC 

Secretary (Jan. 18, 1991). In this letter, 

EPA expressly rejected the notion that 

water quality is a narrow concept; 

rather, the Agency asserted that the 

‘‘protection of water quality includes 

protection of multiple elements which 

together make up aquatic systems 

including the aquatic life, wildlife, 

wetlands and other aquatic habitat, 

vegetation, and hydrology required to 

maintain the aquatic system.’’ Id. The 

letter further noted that water quality 

issues can include toxic pollutants, 

pollutant bioaccumulation, aquatic 

species composition and diversity, 

habitat loss, stormwater impacts, 

nonpoint source impacts, and 

hydrological changes. Id. 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. 

ii. Definition of Water Quality 

Requirements 

To clarify which provisions of 

Federal, state, and Tribal law a 

certifying authority may consider when 

evaluating and ultimately deciding 

which action to take on a request for 

certification, the Agency is finalizing 

the definition of ‘‘water quality 

requirements’’ as proposed (‘‘Water 

quality requirements means any 

limitation, standard, or other 

requirement under sections 301, 302, 

303, 306, and 307 of the Clean Water 

Act, any Federal and state or Tribal laws 

or regulations implementing those 

sections, and any other water qualityrelated requirement of state or Tribal 

law.’’). See 40 CFR 121.1(j). 

The term ‘‘water quality 

requirements’’ is used throughout 

section 401, and the term ‘‘any other 

appropriate requirement of State law’’ is 

used in section 401(d), but neither term 

is defined in the CWA. The Agency did 

not interpret the terms ‘‘water quality 

requirements’’ and ‘‘other appropriate 

requirement of State law’’ in the 1971 

Rule, as they were not introduced into 

the statute until the 1972 CWA 

amendments. Prior to 1972, what is now 

section 401(a) of the statute used the 

term ‘‘water quality standards,’’ and 

section 401(d) was not part of the 

statute. See Public Law 91–224, 21(b)(1), 

85 Stat. 91 (1970); Public Law 92–500, 

401, 85 Stat. 816 (1972). 

The 2020 Rule defined the term 

‘‘water quality requirements’’ and 

interpreted the statutory phrase ‘‘any 

other appropriate requirement of State 

law.’’ 40 CFR 121.1(n) (2020); see 85 FR 

42253. Consistent with what EPA 

characterized as the ‘‘discharge-only’’ 

scope of section 401 certification, the 

2020 Rule limited ‘‘water quality 

requirements’’ to only the enumerated 

provisions of the CWA listed in section 

401(a)(1) and ‘‘state or tribal regulatory 

requirements for point source 

discharges into waters of the United 

States.’’ 40 CFR 121.1(n) (2020). Citing 

Justice Thomas’s dissent in PUD No. 1, 

the Agency relied on the principle of 

ejusdem generis (‘‘of the same kind’’) to 

argue that the term ‘‘appropriate 

requirement of State law’’ was limited 

‘‘only to provisions that, like other 

provisions in the statutory list, impose 

discharge-related restrictions.’’ 511 U.S. 

at 728 (Thomas, J., dissenting); 85 FR 

42453. As a result, the 2020 Rule 

narrowed the scope of review and 

ability of certifying authorities to 

include conditions to protect their water 

quality. For example, a few commenters 

asserted that the 2020 Rule’s approach 

to water quality requirements impeded 

certifying authorities’ 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 groundwater 

contamination. A few other commenters 

stressed the importance of this authority 

for FERC licensed projects in particular 

because of the length of the license and 

preemption of state regulatory oversight 

on FERC licenses. 

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 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 121.1(j); 

87 FR 35347 (noting that the proposed 

definition applied to state or Tribal 

water quality requirements regardless of 

whether they apply to point or nonpoint 

source discharges). 

Many commenters supported the 

proposed approach to ‘‘water quality 

requirements,’’ including its inclusion 

of state and Tribal laws applying to 

either point and nonpoint sources, 

noting it is more holistic, consistent 

with the Act and its purpose, consistent 

with case law, and that it restores and 

reinforces the authority Congress 

reserved for states and Tribes. However, 

several commenters did not support the 

proposed approach to defining ‘‘water 

quality requirements,’’ arguing that the 

term should be limited to point source 

discharges and/or limited to whether 

the discharge complies with water 

quality standards. A few commenters 

asserted that the term ‘‘water qualityrelated requirements of state or Tribal 

law’’ was too broad and would allow 

certifying authorities to include 

conditions unrelated or weakly related 

to water quality. Conversely, several 

other commenters believed the 

proposed definition of ‘‘water quality 

requirements’’ was overly restrictive, 

including a few commenters who 

recommended removing the term ‘‘water 

quality-related’’ in the definition for 

water quality requirements. As 

discussed below, 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 qualityrelated provisions (for both point and 

nonpoint sources). EPA’s final 

definition is also supported by the 

purpose, and legislative history of the 

statute. 

First, the wording that Congress used 

in the text of section 401 demonstrates 


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67See H.R. Rep. No. 95–830, 96 (Dec. 6, 1977) 

(‘‘The inserting of section 303 into the series of 

sections listed in section 401 is intended to mean 

that a federally licensed or permitted activity, 

including discharge permits under section 402, 

must be certified to comply with State water quality 

standards adopted under section 303. The inclusion 

of section 303 is intended to clarify the 

requirements of section 401. It is understood that 

section 303 is required by the provisions of section 

301. Thus, the inclusion of section 303 in section 

401 while at the same time not including section 

303 in the other sections of the Act where sections 

301, 302, 306, and 307 are listed is in no way 

intended to imply that 303 is not included by 

reference to 301 in those other places in the Act, 

such as sections 301, 309, 402, and 509 and any 

other point where they are listed. Section 303 is 

always included by reference where section 301 is 

listed.’’); see also PUD No. 1, 511 U.S. at 712–13 

(‘‘Although § 303 is not one of the statutory 

provisions listed in § 401(d), the statute allows 

States to impose limitations to ensure compliance 

with § 301 of the Act, 33 U.S.C. 1311. Section 301 

in turn incorporates § 303 by reference.’’) 

68A primary objective of section 303 is the 

establishment of water quality standards. 

Establishment of water quality standards is required 

for waters regardless of whether they receive point 

source discharges. 33 U.S.C. 1313(c). Nonattainment of standards may be due to point 

sources, nonpoint sources, or both. As explained in 

EPA’s regulations, water quality standards ‘‘serve 

the dual purposes’’ of serving as the regulatory basis 

for establishing water quality based treatment 

controls for point source discharges and the broader 

purpose of establishing the water quality goals for 

a specific water body. 40 CFR 130.3. Section 303(d) 

specifically directs the identification of waters that 

do not meet water quality standards, considering 

both point sources and nonpoint sources of 

pollution. 33 U.S.C. 1313(d)(1)(A); see also 40 CFR 

130.7(b)(1)(iii). Section 303(d) also addresses the 

establishment of a ‘‘total maximum daily load’’ for 

each water that does not meet standards, set at a 

level necessary to implement applicable water 

quality standards—again, considering both point 

sources and nonpoint sources. 33 U.S.C. 

1313(d)(1)(C); see also 40 CFR 130.1(i) (defining 

total maximum daily load as the sum of loads from 

both point sources and nonpoint sources plus 

natural background). 

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). 

Second, the text is not limited to 

certifying compliance with provisions 

addressing point source discharges. 

Section 401(d) includes the phrase ‘‘any 

other appropriate requirement of State 

law.’’ 33 U.S.C. 1341(d) (emphasis 

added). The phrase ‘‘any other 

appropriate’’ bears examination. The 

word ‘‘any’’ is capacious in its scope, 

literally meaning ‘‘all’’ such state law 

requirements and not just a limited 

subset such as point source-related 

requirements. See Ali v. Federal Bureau 

of Prisons, 552 U.S. 214 (2008); Harrison 

v. PPG Industries, 446 U.S. 578 (1980). 

The word ‘‘other’’ refers to requirements 

aside from the statutory provisions 

listed in the preceding list in section 

401(d) (CWA section 301, etc.). While 

the word ‘‘appropriate’’ provides a 

limiting principle with respect to which 

requirements may be considered and 

applied, the word ‘‘appropriate’’ is to be 

interpreted broadly in light of the 

statute’s text and purpose. Michigan v. 

EPA, 576 U.S. 743, 752 (2015) (stating 

that ‘‘appropriate’’ is a broad and allencompassing term that naturally and 

traditionally includes consideration of 

all the relevant factors). In this context, 

the phrase ‘‘any other appropriate’’ is 

best understood as allowing certifying 

authorities to consider state or Tribal 

laws regarding water quality that are not 

part of the enumerated list of CWA 

sections and that address water quality 

protections that are different from those 

covered by the enumerated list. See also 

PUD No. 1, 511 U.S. at 713 (declining 

to speculate on the scope of state laws 

that would be included in the phrase 

‘‘any other appropriate requirement of 

state law’’ but finding that, ‘‘at a 

minimum, limitations imposed 

pursuant to state water quality 

standards adopted pursuant to § 303 are 

‘appropriate’ requirements of state 

law’’). 

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. 

The list of CWA provisions referenced 

in sections 401(a)(1) and 401(d) 

includes section 303,67 which 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.68 Considering 

the breadth of section 303, using 

ejusdem generis to interpret ‘‘any other 

appropriate requirement of State law’’ to 

only apply to point sources is not 

consistent with congressional intent as 

expressed through the statutory text. 

The legislative history also supports a 

definition of ‘‘water quality 

requirements’’ not limited to 

requirements for point source 

discharges. As described earlier, even 

though in 1972 Congress modified the 

language of then-section 21(b), the 

legislative history shows that Congress 

intended new section 401 to be 

substantially the same as section 21(b), 

which did not limit certifying 

authorities to considering only point 

source discharges. In 1972, Congress 

understood it was making only ‘‘minor,’’ 

insubstantial changes to section 21(b). 

The Senate Report stated that section 

401 was ‘‘substantially section 21(b) of 

the existing law.’’ S. Rep. No. 92–414, 

at 69 (1971). See also remarks of Sen. 

Baker: ‘‘Section 21(b), with minor 

changes, appears as section 401 of the 

pending bill S.2770.’’ 117 Cong. Rec. 

38857 (1971). A comparison of section 

21(b) and section 401 reveals that the 

two sections are, indeed, substantially 

the same. Congress’s revisions to section 

401(a) in the 1977 CWA amendments 

also suggests continued support for 

certifying authority consideration of 

water quality impacts not limited to 

point sources. In 1977, Congress added 

section 303 to the various lists of CWA 

sections in section 401. Legislative 

history from 1977 states that Congress 

intended for ‘‘[t]he inserting of section 

303 into the series of sections listed in 

section 401 [ ] to mean that a federally 

licensed or permitted activity, including 

discharge permits under section 402, 

must be certified to comply with State 

water quality standards adopted under 

section 303.’’ H.R. Rep. No. 95–830, at 

96 (1977). As discussed above, section 

303 requires states to adopt water 

quality standards for its waters and 

applies to waters regardless of the 

presence of point or nonpoint sources of 

pollution or pollutants. 

The legislative history also indicates 

that Congress intended the phrase ‘‘any 

other appropriate requirement of state 

law’’ to be read broadly. In earlier preadoption versions of section 401(d), 

Congress proposed to limit section 

401(d) to the enumerated provisions 

from section 401(a)(1) and either ‘‘any 

more stringent water quality 

requirements under State law provided 

in section 510 of [the Act],’’ S. 2770, 

92nd Cong. (1972), or ‘‘any regulation 

under section 316 of this Act.’’ H.R. 

11896, 92nd Cong. (1972). Ultimately, 

Congress did not adopt either of those 

formulations. Instead, consistent with 

Congress’s objective to empower states 

to protect their waters from pollution, 

Congress ‘‘expanded’’ beyond these 

earlier proposals the scope of section 

401(d) ‘‘to also require compliance with 

any other appropriate requirement of 

State law which is set forth in the 

certification.’’ S. Rep. No. 92–1236, at 

138 (1972) (Conf. Rep.). 


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69The Agency notes that this final interpretation 

is not reflected in the final regulatory text, 

including at § 121.3 regarding the scope of 

certification. The issue of what aspects of the 

activity are considered is distinct from the issue of 

what waters are considered. 

70One way Congress expressly limited the 

application of section 402 permits to discharges to 

navigable waters is through the definition of 

‘‘discharge of a pollutant,’’ a term that is not used 

in section 401. Section 402 authorizes EPA to issue 

permits ‘‘for the discharge of any pollutant,’’ 33 

U.S.C. 1342(a)(1), which is defined as ‘‘any addition 

of any pollutant to navigable waters from any point 

source.’’ Id. at 1362(12) (emphasis added). EPA may 

issue such a permit upon the condition that the 

discharge will meet the requirements of sections 

301, 302, 306, 307, and 308, Id. at 1342(a)(1), all 

sections of the CWA that do not apply beyond 

navigable waters. Section 402 also authorizes states 

to apply for their ‘‘own permit program for 

discharges into navigable waters within its 

jurisdiction.’’ Id. at 1342(b) (emphasis added). 

Section 404 authorizes the Corps to issue permits 

A definition of ‘‘water quality 

requirements’’ that is not limited to 

point sources also is consistent with the 

underlying purposes of the CWA. 

Congress provided states and authorized 

Tribes with the primary role in 

protecting the nation’s waters from 

pollution, including pollution from 

federally licensed or permitted projects, 

and the phrase ‘‘water quality 

requirements’’ should be interpreted 

broadly to preserve state and Tribal 

authority and further the water quality 

protective goal of section 401. See S.D. 

Warren, 547 U.S. at 386 (‘‘State 

certifications under [section] 401 are 

essential in the scheme to preserve state 

authority to address the broad range of 

pollution . . .’’); see also S. Rep. 91– 

414, at 1487 (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.’’). 

Finally, prior judicial interpretation 

also supports EPA’s definition of ‘‘water 

quality requirements’’ as finalized here. 

EPA recognizes that, as noted by the 

Supreme Court in PUD No. 1, the 

authority granted to certifying 

authorities in section 401(d) ‘‘is not 

unbounded.’’ 511 U.S. at 712. Rather, 

the scope is limited to ‘‘ensur[ing] that 

the project complies with ‘any 

applicable effluent limitations or other 

limitations under [33 U.S.C. 1311, 1312] 

or other provisions of the Act,[’] ‘and 

with any other appropriate requirement 

of State law.’ ’’ Id. Although the Court 

declined ‘‘to speculate on what 

additional state laws, if any, might be 

incorporated by this language,’’ the 

Court found that ‘‘at a minimum, 

limitations imposed pursuant to state 

water quality standards adopted 

pursuant to [section] 303 are 

‘appropriate’ requirements of state law.’’ 

Id. at 713. As described earlier in this 

section, EPA’s longstanding position is 

that the scope of certification decisions 

and conditions are limited to water 

quality-related considerations. EPA’s 

definition of the term ‘‘water quality 

requirements’’ in the final rule is not 

intended to alter this interpretation. 

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. 

d. Waters Considered in Acting on a 

Request for Certification 

The Agency also is finalizing an 

interpretation regarding which waters a 

certifying authority considers when 

acting on a request for certification, with 

an important clarification in response to 

commenters. At proposal, EPA 

advanced an approach where a 

certifying authority would consider 

water quality-related impacts to waters 

within its jurisdiction beyond 

‘‘navigable waters’’ as defined by the 

CWA (at 33 U.S.C. 1362). See 87 FR 

35348 (‘‘EPA does not believe that the 

scope of a state’s or tribe’s certification 

review is limited only to water quality 

effects in bodies of water meeting the 

definition of ‘navigable waters’ or 

‘waters of the United States’ . . .’’). 

Some commenters expressed concern 

with allowing certifying authorities to 

use the certification process to impose 

conditions relating to waters that are not 

‘‘waters of the United States’’ and 

disagreed with the Agency’s proposed 

position that section 401 could extend 

to non-‘‘navigable waters’’ once the 

threshold discharge into waters of the 

United States is met. A few commenters 

also noted that states could regulate 

state waters under their own laws. 

The Agency concludes that while a 

certifying authority is limited to 

considering impacts to ‘‘navigable 

waters’’ 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 navigable waters. 

As discussed below, 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 state waters in 

the certification context, and by not 

requiring other states to do so. An 

examination of the interpretation 

asserted in the 2020 Rule and the 

interpretation offered at proposal 

reveals that the interpretation as 

clarified in this final rule is the most 

consistent with the statute and best 

balances the cooperative federalism 

framework of section 401—by not 

applying provisions of the CWA to state 

waters that Congress otherwise limited 

to Federal waters, while still authorizing 

states and Tribes to protect those state 

or Tribal waters from federally licensed 

or permitted projects.69 It also realigns 

with the Agency’s position prior to the 

2020 Rule. 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.’’) 

(rescinded in 2019, see supra). 

When a certifying authority considers 

whether an activity will comply with 

CWA sections 301, 302, 303, 306, and 

307, the certifying authority is limited to 

considering impacts to ‘‘navigable 

waters.’’ 33 U.S.C. 1341(a)(1). These 

sections of the CWA apply only to 

navigable waters as defined by the 

CWA. Id. at 1362(7). EPA concludes that 

the best interpretation of section 401 is 

that it does not allow a certifying 

authority to apply these CWA 

provisions beyond the waters that 

Congress intended for them to apply. 

However, a certifying authority must 

also consider whether the activity will 

comply with ‘‘any other appropriate 

requirement of State law.’’ Id. at 

1341(d). EPA concludes that other 

appropriate requirements of state or 

Tribal law include requirements that 

apply to state or Tribal waters beyond 

those waters covered by CWA section 

402 and 404 permits. EPA further 

concludes that certifying authorities 

may consider the application of these 

laws to all waters impacted by the 

activity to which these laws otherwise 

apply. 

In contrast to the section 402 and 

section 404 permit programs established 

in the 1972 version of the Act, the Act 

does not directly address what waters 

are considered for section 401. Section 

402 and section 404 permits 

unambiguously cover impacts of 

discharges to navigable waters.70


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‘‘for the discharge of dredged or fill material into 

the navigable waters’’ and authorizes any state to 

apply for their own ‘‘permit program for the 

discharge of dredged or fill material into the 

navigable waters.’’ Id. at 1344 (emphasis added). 

Conversely, while the text of section 401 

states that the need for a certification is 

triggered by a potential discharge into 

‘‘the navigable waters,’’ it does not state 

that, once the need for certification is 

triggered, a certifying authority must 

confine its review to potential water 

quality impacts to such ‘‘navigable 

waters’’ even when considering 

requirements of state law that apply 

beyond navigable waters. 33 U.S.C. 

1341(a)(1). Instead, in enacting section 

401(d), Congress required a certifying 

authority to consider whether the 

‘‘applicant’’ will comply with ‘‘any 

other appropriate requirement of State 

law.’’ Id. When Congress enacted 

section 401(d), it explained that this 

provision ‘‘assure[d] that Federal 

licensing or permitting agencies cannot 

override State water quality 

requirements.’’ S. Rep. No. 92–414, at 69 

(1971). 

State laws governing state water 

quality can of course apply to waters 

other than those directly regulated 

under the CWA. See 87 FR 35348 

(recognizing at proposal that ‘‘states 

may, under state law, protect state 

waters beyond those that are’’ covered 

by CWA permitting). About half of the 

states have state laws covering at least 

some surface waters beyond CWA 

navigable waters. EPA and Department 

of Army, Economic Analysis for the 

Final ‘‘Revised Definition of ‘Waters of 

the United States’ ’’ Rule, section II.A 

(December 2022). When Congress 

required states to consider state laws 

when acting on a request for 

certification, Congress declined to 

expressly limit this authorization to 

state laws that apply to waters regulated 

under the CWA. While Congress did 

include the limiting principle of 

‘‘appropriate,’’ the text and legislative 

history of section 401 do not suggest 

that Congress considered state laws that 

apply to waters beyond those directly 

regulated under the CWA to be 

‘‘inappropriate’’ state laws. Nor does the 

text and legislative history of section 

401 suggest that Congress intended to 

limit the applicability of such laws to 

only a subset of waters to which they 

normally apply (namely, ‘‘navigable 

waters’’). Had Congress desired to 

prohibit states from considering water 

quality impacts to state waters, it could 

easily have done so. It did not. 

This interpretation is reinforced by 

the fact that Congress intended section 

401 to afford states and authorized 

Tribes broad power to protect their 

waters from harm caused by federally 

licensed or permitted projects. That 

intent is best realized by interpreting 

section 401 as allowing states and 

authorized Tribes to apply state law or 

Tribal law to all impacted state or Tribal 

waters when acting on a request for 

certification. While the section 401 

certification requirement is triggered by 

a potential discharge into ‘‘navigable 

waters,’’ water quality impacts from the 

activity could occur in state or Tribal 

waters beyond those navigable waters. 

Allowing states or authorized Tribes to 

apply state or Tribal law to all 

potentially affected state or Tribal 

waters is supported by CWA section 

510, which—‘‘[e]xcept as expressly 

provided’’ in the CWA—preserves a 

state’s or authorized Tribe’s authority 

and jurisdiction to protect its waters 

from pollution. 

The best reading of section 401 is that 

it authorizes a state or Tribe to apply 

state law or Tribal law to all impacted 

state or Tribal waters, rather than 

limiting states and Tribes to considering 

only a subset of impacted waters. EPA 

acknowledges it articulated a different 

position on those issues in the 2020 

Rule. 85 FR 42234–35. Upon 

reconsideration, EPA believes there are 

good reasons for changing its position 

now. EPA disagrees with and finds 

unpersuasive the 2020 Rule preamble’s 

attempt to conflate section 401 with 

sections 402 and 404 by saying that 

‘‘similar to the section 402 and 404 

permit programs, section 401 is a core 

regulatory provision of the CWA.’’ Id. 

While section 401 is certainly a critical 

element of the Act—indeed, it pre-dated 

the 1972 CWA amendments and was 

deemed so important that Congress 

carried it over—section 401 is 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, and is significantly 

different in character from the Act’s 

other Federal ‘‘regulatory’’ provisions. 

Section 401, although a neighbor to 

sections 402 and 404 in the CWA’s 

organizational framework, is a 

fundamentally different provision and 

need not be interpreted according to 

those other provisions’ strictures. The 

preamble to the 2020 Rule, with little 

supporting analysis, asserted incorrectly 

that any application of section 401 to 

non-Federal waters ‘‘would effectively 

broaden the scope of the Federal 

regulatory programs enacted by the 1972 

CWA amendments [e.g., sections 402 

and 404] beyond the limits that 

Congress intended.’’ 85 FR 42234–35. 

However, the interpretation taken in 

this final rule in no way broadens the 

scope of sections 402 and 404. Finally, 

the reasons articulated above in support 

of a broad scope of certification (e.g., 

Congress intended for section 401 to be 

a powerful tool for states to protect state 

waters from federally licensed or 

permitted projects) also support a state 

or authorized Tribe applying state or 

Tribal law to protect state or Tribal 

waters when acting on a request for 

certification. 

e. Scope of Conditions 

The Agency is adding text at 

§ 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. This is consistent with the 

proposed rule, which would have 

required a grant of certification with 

conditions to include ‘‘[a]ny conditions 

necessary to assure that the activity as 

a whole will comply with water quality 

requirements,’’ 87 FR 35378—the same 

standard as the proposed scope of 

review for a certification decision. 

Moreover, the preamble to the proposed 

rule was clear that EPA ‘‘interpret[ed] 

the scope of certification review under 

sections 401(a)(1) and (d) to be the 

same. . . .’’ 87 FR 35346. To clearly 

convey the Agency’s intent, EPA is 

adding regulatory text at § 121.3(b) 

stating that ‘‘consistent with the scope 

of review identified in paragraph (a) of 

this section, a certifying authority shall 

include any conditions in a grant of 

certification necessary to assure that the 

activity will comply with applicable 

water quality requirements.’’ 

Because the scope of review applies 

when the certifying authority is 

determining whether to grant 

certification, the same ‘‘activity’’ 

standard should apply to a grant of 

certification, a grant of certification with 

conditions, and a denial of certification. 

That is, the outcome of the certifying 

authority’s analysis should not dictate 

the scope of review. Logically, the same 

scope applies to a certifying authority’s 

evaluation of potential water quality 

effects under both sections 401(a)(1) and 

401(d). This is because the two sections 

are inextricably linked. Section 401(d) 

requires a certifying authority to 

determine whether ‘‘the applicant’’ 

will—without additional conditions— 

comply with the same CWA provisions 

identified in section 401(a)(1) and ‘‘any 

other appropriate’’ requirement of state 

or Tribal 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 


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71See also 2010 Handbook at 18 (rescinded in 

2019, see supra) (‘‘In order to obtain certification of 

any proposed activity that may result in a discharge 

to waters of the U.S., an applicant must 

demonstrate that the proposed activity and 

discharge will not violate or interfere with the 

attainment of any limitations or standards 

identified in [section] 401(a) and (d).’’) 

quality requirements will be met, may 

the certifying authority grant the 

certification contemplated by section 

401(a)(1). In other words, when a 

certifying authority determines that it 

must add conditions under section 

401(d) to the certification, that is 

equivalent to deciding that, without 

those conditions, it must deny 

certification. The certifying authority’s 

evaluations and determinations under 

sections 401(a)(1) and 401(d) do not 

work together in a harmonious fashion 

if the statute is interpreted to apply a 

different scope of review to each 

section. EPA has never taken the 

opposite position. In the 2020 Rule, EPA 

also concluded that the scope of 

sections 401(a)(1) and (d) should be the 

same. 85 FR 42252.71

3. Implementation 

At proposal, the Agency identified 

examples of certification conditions 

possibly falling inside and outside of 

the water quality-related scope of 

section 401 review. Some commenters 

provided input on these examples. 

Some of those commenters explicitly 

supported the listed examples, whereas 

other commenters disagreed that the 

examples listed 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, and 

argued that some examples in the 

proposal constituted the latter. A few 

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 a certifying authority’s review. 

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. Some commenters 

provided their own examples of 

conditions they considered to be related 

or unrelated to water quality and asked 

for EPA to explicitly state which 

conditions would be within or outside 

the scope of section 401 certification. 

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. 

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). Therefore, certifying 

authorities could include conditions to 

ensure a project will comply with, in 

addition to water quality criteria, a 

designated use of a water, see PUD No. 

1, 511 U.S. at 714–15 (emphasis in 

original) (‘‘We think the language of 

[section] 303 is most naturally read to 

require that a project be consistent with 

both components, namely the 

designated use and the water quality 

criteria. Accordingly, under the literal 

terms of the statute, a project that does 

not comply with a designated use of the 

water does not comply with the 

applicable water quality standards.’’), or 

antidegradation requirements, see id. at 

718–19 (recognizing the state 

appropriately justified its minimum 

flow rate as necessary to implement its 

antidegradation policy). This means 

conditions, such as those to ensure 

compliance with minimum flow rates to 

protect fisheries (see, e.g., PUD No. 1, 

511 U.S. 700); and scheduled releases to 

accommodate existing recreational uses 

(see, e.g., In re Morrisville Hydroelectric 

Project Water Quality, 2019 VT 84, 224 

A.3d 473 (2019)), may be appropriate 

certification conditions depending on 

the certifying authority’s water quality 

standards or other aspects of state or 

Tribal law and the activity’s impact on 

achieving compliance with such 

requirements. 

The preamble to the final 2020 Rule 

identified examples of certification 

conditions possibly falling outside the 

water quality-related scope of section 

401 review because they did not address 

water quality impacts, including 

conditions requiring one-time and 

recurring payments to state agencies for 

improvements or enhancements that are 

unrelated to the proposed federally 

licensed or permitted project; 

conditions to address potential nonwater quality-related environmental 

impacts from the creation, manufacture, 

or subsequent use of products generated 

by a proposed federally licensed or 

permitted activity; and conditions 

related only to non-water quality-related 

impacts associated with air emissions 

and transportation effects. See 85 FR 

42230. Subject to a case-by-case review 

of the particular facts presented by each 

certification, it is reasonable to assume 

that such non-water quality-related 

conditions would generally be beyond 

the scope of section 401. 

Several commenters asserted that the 

proposed activity-based scope of 

certification was too ambiguous and 

would lead to various implementation 

challenges, such as regulatory 

uncertainty, increased litigation risk, 

increased project costs, and project 

delays. As discussed above, the Agency 

disagrees that its approach in the final 

rule will lead to implementation 

challenges. Rather, the final rule’s 

approach to the scope of certification 

simply returns to the longstanding 

practice. Ultimately, the ‘‘activity’’ 

subject to the Federal license or permit 

will depend on the specific facts of a 

given situation. For example, the 

activity may be the construction and 

operation of a hydroelectric dam, see, 

e.g., PUD No. 1, 511 U.S. at 708–09, the 

construction and operation of a liquified 

natural gas marine import terminal and 

a pipeline connecting the terminal to an 

interstate natural gas pipeline, see, e.g., 

AES Sparrows, 589 F.3d at 723–24, or 

the construction and operation of a 

marina, see, e.g., Winer Memorandum at 

1. 

While the specific ‘‘activity’’ subject 

to certification will be fact specific, the 

final rule clarifies certain limiting 

principles that apply to all 

certifications. A certifying authority’s 

analysis is limited to evaluating the 

adverse water quality-related impacts 

from the activity when it evaluates 

whether the activity will comply with 

applicable water quality requirements. 

As discussed above, both the terms 

‘‘will comply’’ and ‘‘applicable water 

quality requirements’’ limit what a 

certifying authority may consider and 

ultimately, the decisions that a 

certifying authority can make on a given 

request for certification. 

F. Certification Decisions 

1. What is the Agency finalizing? 

In § 121.7(a), the Agency is finalizing 

that ‘‘a certifying authority may act on 

a request for certification in one of four 

ways: grant certification, grant 


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72For example, the 2020 Rule required certifying 

authorities to include a statement explaining why 

the condition is necessary to assure that the 

discharge from the proposed project will comply 

with water quality requirements and a citation to 

Federal, state, or Tribal law that authorizes the 

condition for each certification condition on an 

individual license or permit. 40 CFR 121.7(d)(1) 

(2020). 

73For example, the 2020 Rule required certifying 

authorities to include three components on all 

denials of certification for individual Federal 

licenses or permits, including the specific water 

quality requirements with which the discharge will 

not comply, a statement explaining why the 

discharge will not comply with the identified water 

quality requirements, and description of the 

specific water quality data or information, if any, 

that would be needed to assure that the discharge 

from the proposed project will comply with water 

quality requirements if the denial was due to 

insufficient information. 40 CFR 121.7(e)(1) (2020). 

certification with conditions, deny 

certification, or expressly waive 

certification.’’ To provide further clarity 

on how a certifying authority may ‘‘act 

on a request for certification,’’ EPA is 

defining recommended minimum 

contents of a certification decision at 

§ 121.7(c) through (f) and finalizing that 

certification decisions must be in 

writing. In a change from proposal and 

in support of the cooperative federalism 

balance central to section 401, the 

Agency is not requiring certifying 

authorities to include the components 

listed at § 121.7(c) through (f) in their 

certification decisions. Instead, the final 

rule defines recommended contents for 

a grant of certification (§ 121.7(c)), a 

grant of certification with conditions 

(§ 121.7(d)), a denial of certification 

(§ 121.7(e)), and an express waiver 

(§ 121.7(f)). 

2. Summary of Final Rule Rationale and 

Public Comment 

a. Decisions on a Request for 

Certification 

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). This 

section briefly describes each of the four 

decisions a certifying authority may 

make, including what each decision 

means and its impact on the Federal 

licensing or permitting process. This 

final rule’s interpretation of the four 

decisions a certifying authority may 

make is consistent with the 2020 Rule 

and longstanding interpretation of the 

1971 Rule. See 40 CFR 121.7 (2020); 

2010 Handbook at 1 (rescinded in 2019, 

see supra) (‘‘The central feature of CWA 

§ 401 is the state or tribe’s ability to 

grant, grant with conditions, deny or 

waive certification.’’). 

First, a certifying authority may grant 

certification. A grant of certification 

means that the certifying authority has 

determined that the activity will comply 

with water quality requirements. See 

section IV.E in this preamble for further 

discussion of the scope of certification 

and the term ‘‘water quality 

requirements.’’ Granting certification 

means that the Federal license or permit 

may be issued. See 33 U.S.C. 1341(a)(1). 

Section 401(a)(1) provides that where 

there are no applicable water quality 

requirements for an activity, the 

certifying authority ‘‘shall so certify.’’ 

Id. EPA is finalizing minor revisions to 

the regulatory language located at 

§ 121.7(f) of the 2020 Rule that describes 

this scenario, with minor edits to reflect 

the final rule scope of certification. See 

40 CFR 121.7(g). 

Second, a certifying authority may 

grant certification with conditions. A 

grant of certification with conditions 

means that the certifying authority has 

determined that the activity will comply 

with water quality requirements, but 

only if certain conditions are met. 

Pursuant to 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). As discussed later in section 

IV.G in this preamble, Federal circuit 

courts have routinely held that Federal 

agencies may not question or reject a 

state’s certification conditions. See, e.g., 

American Rivers, 129 F.3d at 107 

(‘‘[Section 401(d)] is unequivocal, 

leaving little room for FERC to argue 

that it has authority to reject state 

conditions it finds to be ultra vires.’’). 

Granting certification with conditions 

means the Federal license or permit may 

be issued, provided the conditions are 

incorporated into that Federal license or 

permit. 

In this final rule, the Agency is not 

retaining any regulatory text on the 

incorporation of certification conditions 

as was included in the 2020 Rule. See 

40 CFR 121.10 (2020). First, the 2020 

Rule limited incorporation of 

certification conditions to only those 

that satisfy the content requirements at 

§ 121.7(d) of the 2020 Rule.72 40 CFR 

121.10 (2020). Section 401(d) requires 

all certification conditions to become 

conditions on a Federal license or 

permit and does not limit incorporation 

to only those conditions that include 

certain regulatorily defined 

components. As discussed in section 

IV.G of this preamble, EPA does not 

interpret the statute as allowing a 

Federal agency to review whether a 

certifying authority included certain 

regulatorily defined elements in its 

certification decisions, nor reject 

certifying authority conditions. Second, 

while the 2020 Rule required Federal 

agencies to clearly identify certification 

conditions in their Federal license or 

permit, section 401 does not require 

Federal agencies to distinguish among 

certification conditions in their licenses 

or permits. If the Federal agency finds 

it useful to distinguish certification 

conditions for implementation 

purposes, the Federal agency may 

structure its license or permit in such a 

manner, but EPA does not find it 

necessary to require such a distinction. 

Third, a certifying authority may deny 

certification. A denial of certification 

means that the certifying authority is 

not able to certify that the activity will 

comply with water quality 

requirements. If a certifying authority 

denies certification, the Federal license 

or permit cannot be issued. 33 U.S.C. 

1341(a)(1). The 2020 Rule included 

regulatory text that discussed the effects 

of a denial of certification. See 40 CFR 

121.8 (2020). Section 121.8(a) of the 

2020 Rule provided that a certification 

denial would not preclude a project 

proponent from submitting a new 

certification request. Section 121.8(b) 

provided that if the Federal agency 

determined that the certifying 

authority’s denial satisfied the content 

requirements at § 121.7(e) of the 2020 

Rule,73 then the Federal agency would 

provide notice to the certifying 

authority and project proponent and the 

Federal license or permit would not be 

granted. As discussed below, the 

Agency is not retaining any regulatory 

text that speaks to the effects of a denial 

of certification because it is 

unnecessary. 

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, the proposal did not include a 

similar provision. The commenter 


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74See e.g., New York State Dep’t of Env’t 

Conservation v. FERC, 991 F.3d 439, 450 at n.11 (2d 

Cir. 2021) (noting that if a state finds that a 

‘‘particular application requires supplementation,’’ 

the state ‘‘can deny an application without 

prejudice within the one-year deadline, which will 

presumably prompt the applicant to resubmit the 

application with additional material’’) (citing New 

York State Dep’t of Env’t Conservation v. FERC, 884 

F.3d 450, 456 (2d Cir. 2018)); Turlock Irrigation 

Dist. v. FERC, 36 F.4th 1179, 1183–84 (D.C. Cir. 

2022) (rejecting arguments that, if the court upheld 

the denials without prejudice at issue before it, 

‘‘State agencies could extend the time for decision 

indefinitely by denying one certification request 

after another without prejudice, thus nullifying 

section 401’s one-year limit’’). 

suggested that EPA is taking the 

position that a certification denial is 

always a permanent final action that is 

taken with prejudice and asserted that if 

this is EPA’s position, it would be a 

significant change from its previous 

longstanding position affirmed by the 

2020 Rule. 

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.74 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. 

EPA does not find it necessary to add 

any additional direction or process for 

certification denials, beyond providing 

recommended contents of a certification 

denial (as discussed below). If a project 

proponent disagrees with a certifying 

authority’s denial, the project proponent 

may challenge the certifying authority’s 

decision in the appropriate court. See S. 

Rep. 92–414 at 69 (1971) (‘‘Should such 

an affirmative denial occur no license or 

permit could be issued by such Federal 

agencies . . . unless the State action 

was overturned in the appropriate 

courts of jurisdiction.’’). The 2020 Rule 

also provided that a Federal license or 

permit may not be issued if a certifying 

authority denies certification in the 

manner prescribed by the 2020 Rule 

(i.e., contains the contents defined at 

§ 121.7(e) of the 2020 Rule). Under this 

final rule, Federal agencies may not 

review whether a certifying authority’s 

certification denial contains the 

contents recommended at final rule 

§ 121.7(e). 

Fourth, a certifying authority may 

expressly waive certification. The 

statute explicitly provides for a 

constructive waiver if the certifying 

authority fails or refuses to act on a 

request for certification within the 

reasonable period of time. The statute 

does not explicitly state that a certifying 

authority may expressly waive 

certification. A few 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. However, 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 legislation.’’). This interpretation is 

also consistent with the Agency’s 

longstanding interpretation of the 

waiver provision. 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). 

Additionally, continuing to allow 

express waivers may create efficiencies 

where the certifying authority knows 

early in the process that it will waive. 

An express waiver does not mean that 

the certifying authority has determined 

that the activity will comply with water 

quality requirements. Instead, an 

express waiver indicates only that the 

certifying authority has chosen not to 

act on a request for certification. 

Consistent with the statutory text, an 

express waiver enables the Federal 

agency to issue a Federal license or 

permit without a certification. 33 U.S.C. 

1341(a)(1). 

b. Defining What It Means ‘‘To Act on 

a Request for Certification’’ 

The Agency is finalizing the 

definition of what it means ‘‘to act on 

a request for certification’’ as proposed 

at § 121.7(a). Once a certifying authority 

receives a request, the certifying 

authority must ‘‘act on a request for 

certification, within a reasonable period 

of time (which shall not exceed one 

year) after receipt of such request.’’ 33 

U.S.C. 1341(a)(1). The phrase ‘‘to act on 

a request for certification’’ is not defined 

in the statute; nor did EPA define it in 

the 1971 or 2020 Rules. To provide 

greater clarity regarding how a certifying 

authority ‘‘act[s] on a request for 

certification’’ within the reasonable 

period of time, EPA is defining the 

phrase to mean that a certifying 

authority is making one of the four 

certification decisions discussed above: 

granting certification, granting 

certification with conditions, denying 

certification, or expressly waiving 

certification. 

The Agency is providing clarification 

regarding what it means to ‘‘act on a 

request for certification’’ in light of 

commenter input on this topic and 

recent case law. For example, would 

other actions beyond the four just 

discussed qualify as ‘‘acting’’ on a 

request for certification? The Fourth 

Circuit recently held that it was 

permissible for a project proponent to 

withdraw its application to avoid a 

certification denial as long as the 

certifying authority and project 

proponent were not in a ‘‘coordinated 

withdrawal and resubmission scheme.’’ 

NCDEQ v. FERC, 3 F.4th 655, 672, 676 

(4th Cir. 2021). However, the court, in 

dicta, also suggested that the section 401 

phrase ‘‘to act’’ could be interpreted to 

mean something different than a final 

action on a request for certification. 

According to the court, a certifying 

authority that ‘‘takes significant and 

meaningful action’’ and ‘‘in good faith 

takes timely action to review and 

process a certification request likely 

would not lose its authority to ensure 

that federally licensed projects comply 

with the State’s water quality standards, 

even if it takes the State longer than a 

year to make its final certification 

decision.’’ Id. at 670. 

EPA proposed to interpret the phrase 

‘‘to act on a request for certification’’ to 

mean that a certifying authority makes 

one of the four above-described 

certification decisions: grant, grant with 

conditions, deny, or expressly waive. 

However, the Agency requested 

comment on this interpretation, as well 

as any alternative interpretations, such 

as the NCDEQ approach. A few 

commenters did not support the 

proposed approach and 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 other 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. 

Conversely, some commenters 

supported the proposed approach 

noting it provided much needed clarity 

and correctly rejected the NCDEQ 

approach. 


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The Agency finds that defining ‘‘to act 

on a request for certification’’ as making 

one of the four above-described 

certification decisions 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.’’). 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 oneyear 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, although the Agency has 

never explicitly defined ‘‘to act on a 

request for certification,’’ the 

interpretation taken in this final rule is 

consistent with prior Agency guidance 

and the 2020 Rule preamble. In the 2020 

Rule, the Agency noted that ‘‘[i]f a 

certifying authority fails or refuses to 

[grant certification, grant certification 

with conditions, deny certification, or 

expressly waive certification] within the 

reasonable period of time, the CWA 

provides that the certifying authority 

will be deemed to have waived the 

certification requirement.’’ 85 FR 42262 

(July 13, 2020). One implication of this 

language is that the Agency thought that 

‘‘to act on a request for certification’’ 

means to make a final decision on the 

request (i.e., grant, grant with 

conditions, deny, or expressly waive 

certification). Courts appear to agree. 

See, e.g., Alcoa Power Generating, Inc. 

v. FERC, 643 F.3d 963, 972 (D.C. Cir. 

2011) (noting that ‘‘[i]n imposing a oneyear time limit on States to ‘act,’ 

Congress plainly intended to limit the 

amount of time that a State could delay 

a federal licensing proceeding without 

making a decision on the certification 

request’’); NYSDEC, 884 F.3d at 455–56 

(noting that a state must act after 

receiving a certification request and that 

denial ‘‘would constitute ‘acting’ on the 

request under the language of Section 

401’’); New York State Dep’t of 

Environmental Cons. v. FERC, 991 F.3d 

439, 443, 450 (2d Cir. 2021) (State 

agency could not ‘‘extend[ ] the deadline 

. . . to issue or deny water quality 

certification’’ beyond ‘‘one year of the 

actual receipt of the application’’ for 

certification); Millennium Pipeline Co. 

v. Seggos, 860 F.3d 696, (D.C. Cir. 2017) 

(‘‘To prevent state agencies from 

indefinitely delaying issuance of a 

federal permit, . . . . a State [must] 

grant or deny the certificate’’ within one 

year from the receipt of a request for 

certification). 

Lastly, the Agency finds that the final 

rule’s approach best supports a clear, 

consistent, and transparent certification 

process. As noted 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 (June 9, 2022). The Agency 

remains concerned that interpreting ‘‘to 

act on a request for certification’’ as any 

‘‘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). 

c. Failing or Refusing To Act on a 

Request for Certification 

Similar to the proposed rule, the 

Agency is finalizing at § 121.9(a) 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.’’ 40 CFR 121.9(a). EPA 

proposed at § 121.8 that ‘‘the 

certification requirement shall be 

waived if a certifying authority fails or 

refuses to act on a request for 

certification in accordance with 

§ 121.7(a) within the reasonable period 

of time, as defined at § 121.6.’’ EPA has 

reorganized the regulatory text by 

moving the text proposed at § 121.8 

(‘‘Failure or refusal to act’’) to § 121.9 

and made several revisions. First, EPA 

made minor non-substantive revisions 

at § 121.9(a) to remove unnecessary and 

redundant internal references to 

§§ 121.6 (reasonable period of time) and 

121.7(a) (possible actions on a request 

for certification). Second, the Agency 

has moved proposed § 121.9(c), which 

described the process that occurred 

once a certifying authority failed or 

refused to act, to § 121.9(b) to pair the 

process that occurs once a certifying 

authority fails or refuses to act with the 

final rule’s express statement on 

constructive waiver. The Agency 

intends such restructuring to clearly 

convey that a constructive waiver of 

certification may only occur where a 

certifying authority fails or refuses to 

act, as defined in this final rule, within 

the reasonable period of time. See 

section IV.G in this preamble for further 

discussion on Federal agency review for 

failure or refusal to act within the 

reasonable period of time. 

The plain language of section 

401(a)(1) provides that the certification 

requirement is waived if a certifying 

authority ‘‘fails or refuses to act on a 

request for certification, within a 

reasonable period of time (which shall 

not exceed one year).’’ Id. As discussed 

in section IV.D of this 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. 


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75EPA is also deleting provisions in § 124.53(e) 

because its approach to the contents of a 

certification decision differed from final rule 

§ 121.7, as explained in preamble section IV.F.2.d 

of this preamble. 

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. See id. (‘‘No 

license or permit shall be granted until 

the certification required by this section 

has been obtained or has been waived 

as provided in the preceding 

sentence.’’). 

The legislative history of this 

provision also suggests that constructive 

waivers were intended to prevent delays 

in the Federal licensing or permitting 

process due to the certifying authority’s 

failure to grant or deny certification. See 

H. Rep. No 92–911, at 122 (1972) (‘‘In 

order to insure that sheer inactivity by 

the State, interstate agency or 

Administrator as the case may be, will 

not frustrate the Federal application, a 

requirement, that if within a reasonable 

period, which cannot exceed 1 year, 

after it has received a request to certify 

the State, interstate agency, or 

Administrator, as the case may be, fails 

or refuses to act on the request for 

certification, then the certification 

requirement is waived.’’). Similarly, the 

1971 Rule and subsequent Agency 

guidance recognized that constructive 

waivers could occur due to certifying 

authority inaction. See 40 CFR 121.16(b) 

(2019) (providing that constructive 

waiver occurred upon the ‘‘failure of the 

State . . . concerned to act on such a 

request for certification within a 

reasonable period of time after receipt of 

such request’’); 2010 Handbook at 11 

(rescinded in 2019, see supra) (‘‘State 

and tribes are authorized to waive 

[section] 401 certification . . . by the 

certification agency not taking action.’’). 

The 2020 Rule’s interpretation of 

what it means for a certifying authority 

to fail or refuse to act departed from the 

longstanding Agency position on 

constructive waivers. The 2020 Rule 

allowed a Federal agency to determine 

that a certifying authority had failed or 

refused to act, and thereby waived 

certification—even when the certifying 

authority did in fact act on a request for 

certification within the reasonable 

period of time—if the Federal agency 

found that the action was somehow 

procedurally deficient (e.g., did not 

follow the 2020 Rule’s procedural 

requirements for a denial of 

certification). 40 CFR 121.9(a)(2) (2020); 

85 FR 42266. Similarly, a Federal 

agency could determine that a 

certification condition was waived if the 

condition did not comply with 

procedural requirements of the 2020 

Rule. Id. at 42250. This aspect of the 

2020 Rule drew considerable preproposal input and public comment to 

the effect that this interpretation could 

result in a Federal agency ‘‘veto’’ of a 

section 401 certification, and that it was 

contrary to the statute, the legislative 

history, and case law. EPA similarly 

expressed concern in its Federal 

Register document announcing its 

intent to revise the 2020 Rule, noting 

that ‘‘a federal agency’s review may 

result in a state or tribe’s certification or 

conditions being permanently waived as 

a result of non-substantive and easily 

fixed procedural concerns identified by 

the federal agency.’’ 86 FR 29543 (June 

2, 2021). 

The 2020 Rule’s interpretation of 

waiver of a certification decision is not 

consistent with the plain language of the 

statute and its legislative history. The 

mere failure of a certifying authority to 

include certain regulatorily defined 

elements in its certification decision or 

comply with other procedural 

requirements of section 401, such as 

following public notice procedures on a 

request for certification, do not qualify 

as the kind of ‘‘sheer inactivity’’ that 

Congress contemplated would result in 

a constructive waiver. This 

interpretation also resulted in Federal 

agencies rejecting certification decisions 

intended to prevent adverse water 

quality impacts because of fixable 

procedural concerns. For example, some 

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.G.2 of this 

preamble, a constructive waiver is a 

severe consequence because 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. 

Accordingly, consistent with the 

statutory language, legislative history, 

and prior Agency interpretation, EPA is 

finalizing regulatory text to clarify that 

constructive waivers may occur only if 

a certifying authority fails or refuses to 

take one of the four actions described in 

this section within the reasonable 

period of time. 

Consistent with this approach, EPA is 

also finalizing targeted conforming 

revisions to its part 124 and part 122 

regulations, where these regulations 

previously allowed EPA to find that a 

certifying authority waived its right to 

certify or waived a certification 

condition for reasons other than those 

specified in final rule § 121.9 (failure to 

act on a request for certification within 

the reasonable period of time). EPA is 

deleting the majority of the language in 

40 CFR 124.53(e)(2) and (3), which 

allowed EPA to waive certification 

conditions that did not meet certain 

requirements.75 See discussion infra for 

further discussion on the revisions to 

§ 124.53. 

EPA is also finalizing revisions to 40 

CFR 124.55(c), which allowed EPA to 

waive certification conditions or denials 

that were based on state law allowing a 

less stringent permit condition. 

Specifically, EPA is deleting the second 

sentence of § 124.55(c), which allowed 

EPA to waive a certification denial or 

condition. The first sentence of 

§ 124.55(c) will remain because it is not 

affected by this final rule. Finally, EPA 

is finalizing revisions to 40 CFR 

122.44(d)(3), which allowed EPA to 

waive certifications that were stayed by 

a court or state board under certain 

circumstances. EPA is deleting the 

second and third sentences, which 

concerned certification waiver. As a 

result of these deletions and revisions in 

EPA’s part 124 and part 122 regulations, 

certification waivers for EPA-issued 

NPDES permits will be governed solely 

by the certification waiver requirements 

in § 121.9 of the final rule. 

d. Contents of a Certification Decision 

To further clarify how a certifying 

authority may ‘‘act on a request for 

certification,’’ EPA is finalizing 

recommended contents of a certification 

decision at § 121.7(c) through (f) and 

finalizing a requirement that all 

certification decisions be in writing. In 

a change from proposal 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 (§ 121.7(c)), a 

grant of certification with conditions 

(§ 121.7(d)), a denial of certification 

(§ 121.7(e)), and an express waiver of 

certification (§ 121.7(f)). As discussed in 

more detail below, these recommended 

contents are similar to those proposed 

(as requirements) with modifications in 

light of commenter input. The Agency is 

also finalizing revisions to the 

regulatory text located at § 121.7(a) of 

the 2020 Rule with minor, nonsubstantive revisions to clarify that all 

certification decisions should be within 

the scope of certification and taken 

within the reasonable period of time. 40 

CFR 121.7(b). 


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76The Agency is finalizing revisions to the part 

124 regulations where such provisions are 

inconsistent with this final rule, including deleting 

40 CFR 124.53(e)(2). See discussion infra. 

EPA is finalizing removal of the 

regulatory text located at § 121.7(b) of 

the 2020 Rule, which characterized 

what actions a certifying authority may 

take based on its evaluation of the 

request for certification. EPA believes it 

is redundant to retain separate 

regulatory text restating the same ideas 

as final rule § 121.7(a) and (c) through 

(f). 

While the statute provides that 

certifying authorities may make one of 

four decisions when processing a 

request for certification, the CWA does 

not explicitly describe the contents or 

elements of a certification decision. 

EPA’s 1971 Rule defined the contents of 

a certification and express waiver 

decision for all certifying authorities. 

The 1971 Rule’s enumeration of the 

contents of a certification decision was 

simple but effective and included the 

name and address of the applicant, a 

statement that the certifying authority 

examined the application, a statement 

that ‘‘there is a reasonable assurance 

that the activity will be conducted in a 

manner which will not violate 

applicable water quality standards,’’ and 

other information deemed appropriate 

by the certifying authority. 40 CFR 

121.2(a) (2019). In addition, the 1971 

Rule provided that a certification could 

be waived upon either (1) written 

notification from the certifying authority 

that it expressly waived its authority to 

act on a request, or (2) written 

notification from the Federal licensing 

or permitting agency regarding the 

failure of the certifying authority to act 

on a request for certification within the 

reasonable period of time. 40 CFR 

121.16 (2019). The 1971 Rule did not 

define the contents of a certification 

denial or provide specific requirements 

for how to articulate and incorporate a 

certification condition. 

In the 2020 Rule, EPA updated those 

requirements for each type of 

certification decision and more fully 

addressed the effects of those decisions. 

First, it provided that, when a certifying 

authority granted certification under the 

2020 Rule, the certification must be in 

writing and include a written statement 

that the discharge from the proposed 

project would comply with water 

quality requirements. 40 CFR 121.7(c) 

(2020); 85 FR 42286. 

Second, when a certifying authority 

granted certification with conditions, 

the 2020 Rule required that the 

certifying authority explain the 

necessity of each condition and provide 

a citation to an applicable Federal, state, 

or Tribal law. 40 CFR 121.7(d) (2020); 

85 FR 42286. This was a change from 

the 1971 Rule, which broadly provided 

for certifying authorities to include 

conditions as they ‘‘deem[ed] necessary 

or desirable.’’ 40 CFR 121.2(a)(4) (2019). 

The 2020 Rule preamble stated that the 

requirements were ‘‘intended to 

increase transparency and ensure that 

any limitation or requirement added to 

a certification . . . is within the scope 

of certification.’’ 85 FR 42256. EPA 

observes that this provision was similar 

to EPA’s current NPDES programspecific section 401 regulations. See 40 

CFR 124.53(e)(2) (2023) (requiring a 

citation for any conditions more 

stringent than those in the draft 

permit).76

Third, unlike the 1971 Rule, under 

which certification denials were 

undefined, the 2020 Rule defined the 

contents of a denial decision. 

Specifically, the 2020 Rule required 

certification denials to be made in 

writing and to identify any water quality 

requirements with which the discharge 

will not comply, include a statement 

explaining why the discharge would not 

comply with those requirements, and 

provide any specific water quality data 

or information that would help explain 

a denial based on insufficient 

information. 40 CFR 121.7(e) (2020); 85 

FR 42286. 

Fourth, the 2020 Rule included 

similar language to the 1971 Rule for 

express waivers and required written 

notification from the certifying authority 

indicating an express waiver of its 

authority to act on a request for 

certification. 40 CFR 121.9(a)(1) (2020); 

85 FR 42286. Lastly, under the 2020 

Rule, EPA defined constructive waiver 

as a certifying authority’s ‘‘failure or 

refusal to act on a certification request’’ 

which included failing or refusing to (1) 

act within the reasonable period of time, 

(2) satisfy the procedural requirements 

for a grant or denial of certification 

imposed by the 2020 Rule, or (3) comply 

with other procedural requirements of 

section 401 (e.g., provide public notice 

on a certification request). 40 CFR 

121.9(a)(2) (2020); 85 FR 42286. The 

2020 Rule also provided that conditionspecific waivers could occur if the 

certifying authority failed to satisfy the 

procedural requirements imposed by the 

2020 Rule for certification conditions. 

40 CFR 121.9(b) (2020); 85 FR 42286. 

See section IV.G in this preamble for 

further discussion on constructive 

waivers and the role of Federal agencies. 

The stated purpose of the 2020 Rule 

requirements was to promote 

transparency and consistency in 

certification decisions and to help 

streamline the Federal licensing and 

permitting processes. 85 FR 42220. 

However, in pre-proposal input, several 

certifying authorities said that the 2020 

Rule’s requirements for the contents of 

certification decisions delayed rather 

than streamlined the certification 

process. Conversely, in pre-proposal 

outreach, project proponents expressed 

interest in keeping the 2020 Rule 

requirements for the added transparency 

and argued that it is helpful when 

certifying authorities explain their final 

certification decisions (especially 

denials). In response to this mixed 

input, the Agency proposed to include 

some requirements for each of the four 

types of certification decisions. The 

Agency intended for this approach to 

address both the workload concerns 

expressed by certifying authorities, and 

the desire of project proponents for 

increased transparency and consistency 

in the certification process. 

Some commenters supported the 

proposed rule’s approach, including the 

removal of the 2020 Rule requirements 

to include specific statutory or 

regulatory citations for each certification 

condition and denial, and retaining the 

inclusion of 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. Commenters argued that 

the explanation requirement would 

provide transparency and regulatory 

certainty. However, some commenters 

asserted that any content requirements 

imposed by EPA would place an undue 

burden on the certifying authority and 

recommended that the Agency remove 

all content requirements. Conversely, 

some other commenters expressed 

interest in keeping the 2020 Rule 

requirements, including a few 

commenters who argued that citations 

are necessary for legally defensible 

certification decisions, to provide 

transparency, and to enable the project 

proponent and the public to understand 

the rationale for a condition. 

After reviewing public comments, the 

Agency is not finalizing any 

requirements for certification decisions. 

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 


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77The 1971 Rule required a certification issued 

by any certifying authority to include, ‘‘A statement 

that there is a reasonable assurance that the activity 

will be conducted in a manner which will not 

violate applicable water quality standards.’’ 40 CFR 

121.2(a)(3) (2019) (emphasis added). 

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 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). 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 § 121.7(c) 

through (f). These contents are similar to 

the contents proposed (to be required) at 

§ 121.7(c) through (f), with 

modifications based on stakeholder 

input. See discussion infra. 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. For its part, the 

Agency intends to include these 

contents in certification decisions when 

it acts as a certifying authority and 

encourages other certifying authorities 

to include similar contents in their 

certification decisions. However, the 

final rule approach provides certifying 

authorities with the flexibility to add 

different or additional elements or 

information requirements to any of 

these four certification decisions to 

provide stakeholders with additional 

clarity and transparency. For example, a 

certifying authority may choose to 

require a citation to applicable Federal 

or state or Tribal water quality 

requirements to support a certification 

condition. 

As discussed above, the Agency is 

recommending, as opposed to requiring, 

additional contents for each type of 

certification decision. Before discussing 

the specific contents of each 

certification decision in more detail, the 

Agency would like to address the 

recommended contents that are the 

same or similar in all four certification 

decisions. First, consistent with the 

2020 Rule, the Agency has opted to 

retain language in the recommended 

contents of a certification decision 

consistent with the 1972 statutory 

language. Unlike the 2020 Rule, the 

1971 Rule included language that 

reflected the predecessor statute. As 

discussed in section III in this preamble, 

the 1972 CWA revised the predecessor 

version of section 401 that the 1971 

Rule relied upon. To continue to 

account for this change to the statutory 

text, the Agency is retaining a similar 

provision as the 2020 Rule that 

certification decisions to grant, grant 

with conditions, or deny certification 

should indicate whether the certifying 

authority has determined that an 

activity will comply with the water 

quality requirements identified in the 

CWA, not just water quality standards.77

Unlike the 2020 Rule, EPA is finalizing 

that certification decisions should 

indicate whether the activity, as 

opposed to the discharge, will comply 

with water quality requirements. See 

section IV.E of this preamble for further 

discussion on the scope of certification. 

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 

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. 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. 

Nor does EPA expect that the use of 

‘‘will comply’’ will impede or limit a 

certifying authority’s ability to act on a 

request for certification or prevent a 

certifying authority from relying on 

modeling information, which provides 

an informed projection of potential 

impacts, to make a certification 

decision. When a certifying authority 

makes a certification decision, it would 

be certifying that the activity will 

comply with water quality requirements 

for the life of the Federal license or 

permit and not just at the moment the 

Federal license or permit is issued. The 

lifespan of FERC licenses can be 

decades, whereas CWA section 402 or 

404 permits usually last five years. 

Given the possible lifespan of a Federal 

license or permit, and the possibility 

that water quality-related changes or 

impacts may occur, for example, due to 

climate change or other factors during 

that time, it is reasonable (and perhaps 

essential in some cases) for certifying 

authorities to rely on modeling to 

inform certification decisions. EPA 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. 

Second, the Agency continues to 

require all certification decisions to be 

in writing. While the Agency is not 

aware of any certification decisions 

being provided in a different manner 

(e.g., verbally), EPA is finalizing the 

requirement that all certification 

decisions be in writing to ensure the 

project proponent and Federal agency 

can clearly understand the certification 

decision and, for a certification with 

conditions, any conditions that must be 

included in the Federal license or 

permit. 

Third, 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. A few 

commenters suggested that the final rule 

should remove any requirements to 

include the identification of the Federal 

license or permit. 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 

Agency intends for this component to 

help clarify which Federal license or 

permit the certification decision applies 

to. 

Fourth, the Agency is adding 

regulatory text that encourages 

certifying authorities to clearly identify 

the certification decision type (i.e., 


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78The Agency recommends including at least a 

succinct explanation for the certification 

condition(s) to provide necessary transparency and 

clarity for project proponents and Federal agencies. 

As a practical matter, certifying authorities will 

likely already have developed and considered such 

information as part of their decision-making process 

and included it in the record to substantiate their 

decision. Aside from borrowing from their decisionmaking record, EPA expects that certifying 

authorities may be able to satisfy this requirement 

in a number of ways. For example, certifying 

authorities could identify specific water quality 

requirements with which the activity will not 

comply without the condition. 

grant, grant with conditions, denial, or 

waiver) to ensure project proponents 

and Federal agencies can easily 

understand the nature of the 

certification decision. This is 

particularly important for Federal 

agencies who need to look at a 

certification decision to determine how 

it should act in response. For example, 

if a certifying authority denies 

certification, the Federal agency cannot 

issue the Federal license or permit. 

Similarly, if a certifying authority grants 

certification with conditions, the 

Federal agency must include those 

conditions in its Federal license or 

permit. 

Lastly, the Agency is adding 

regulatory text that encourages a 

certifying authority to indicate that it 

complied with its public notice 

procedures established pursuant to 

CWA section 401(a)(1). As discussed in 

section IV.G in this preamble, Federal 

agency review is limited to verifying 

compliance with the requirements of 

CWA section 401, including whether 

the certifying authority confirmed it 

complied with its public notice 

procedures established pursuant to 

CWA section 401(a)(1). See 40 CFR 

121.8. The language added throughout 

§ 121.7 is intended to aid this aspect of 

Federal agency review. EPA is not 

defining how exactly a certifying 

authority must indicate in its 

certification decision that it complied 

with public notice procedures. Instead, 

a certifying authority may choose to 

demonstrate that it complied with its 

public notice procedures as it sees fit, 

including but not limited to, by 

including a copy of the public notice in 

its certification decision, by including a 

description of the public notice process 

it undertook in the certification 

decision, or by simply including an 

attestation statement in the certification 

decision that the certifying authority 

complied with its public notice 

procedures. 

While the above paragraphs address 

aspects of the recommended 

components that are the same for all 

certification decisions, the following 

paragraphs describe the individual 

requirements EPA is recommending for 

each of the four kinds of certification 

decisions. 

First, any grant of certification should 

(1) identify the decision as a grant of 

certification, (2) identify the applicable 

Federal license or permit, (3) include a 

statement that the activity ‘‘will 

comply’’ with water quality 

requirements, and (4) indicate that the 

certifying authority complied with its 

public notice procedures established 

pursuant to CWA section 401(a)(1). 

While the 1971 Rule required a 

statement that there was ‘‘reasonable 

assurance,’’ 40 CFR 121.2(a) (2019), as 

explained above, 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). 

Second, EPA is finalizing that any 

grant of certification with conditions 

should (1) identify the decision as a 

grant of certification with conditions, (2) 

identify the applicable Federal license 

or permit, (3) include a statement 

explaining why each condition is 

necessary to assure that the activity will 

comply with water quality 

requirements, and (4) indicate that the 

certifying authority complied with its 

public notice procedures established 

pursuant to CWA section 401(a)(1). The 

Agency proposed that a grant of 

certification must include any 

conditions necessary to assure that the 

activity as a whole will comply with 

applicable water quality requirements. 

Due to the change in approach to 

include recommended components, as 

opposed to required components, for 

certification decisions, the Agency is 

removing the proposed text at 

§ 121.7(d)(2) and instead adding text at 

final rule § 121.3(b) that requires 

certifying authorities to include any 

conditions necessary to assure that the 

activity will comply with applicable 

water quality requirements. The text at 

final rule § 121.3(b) reflects the language 

used in section 401(d). 

The Agency recommends that 

certifying authorities include a 

statement explaining why each of the 

included conditions is necessary in a 

certification with conditions, consistent 

with proposed § 121.7(d)(3).78 A few 

commenters expressed concern over 

how such justifications should be 

included in a certification decision, 

including arguing that it would interfere 

with readability or suggesting grouping 

explanations instead of requiring an 

explanation for each condition. 

Although the Agency is not requiring 

the inclusion of a statement explaining 

why a condition is necessary, EPA finds 

that including such a statement will 

help project proponents and Federal 

agencies understand the reason for the 

condition and assist in its 

implementation. As discussed in the 

implementation section below, there are 

several ways a certifying authority can 

include this information in a 

certification decision to aid readability 

for ease of implementation, such as 

including justifications in an addendum 

to the certification. See infra. EPA 

anticipates that such information is 

readily available to the certifying 

authority as part of its decision-making 

process. 

Consistent with the final rule’s shift to 

recommended contents of a certification 

decision, the Agency is not requiring 

certifying authorities to include a 

specific statutory or regulatory citation 

in support of a certification condition. 

Rather, the Agency will let certifying 

authorities decide what relevant 

information to provide in support of any 

conditions. EPA encourages certifying 

authorities to work with project 

proponents and Federal agencies to 

determine what information would be 

most useful (e.g., statutory or regulatory 

citations). Additionally, EPA 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 here 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. 

Third, EPA is finalizing that any 

denial of certification should (1) 

identify the decision as a denial of 

certification, (2) identify the applicable 

Federal license or permit, (3) include a 

statement explaining why the certifying 

authority cannot certify that the 

proposed activity will comply with 

water quality requirements, including 

but not limited to a description of any 

missing water quality-related 

information if the denial is based on 

insufficient information, and (4) 

indicate that the certifying authority 

complied with its public notice 

procedures established pursuant to 

CWA section 401(a)(1). Although the 

1971 Rule did not define the elements 

of a decision to deny certification, this 

concept was introduced in the 2020 

Rule. The recommended contents for a 

denial of certification are similar to the 

requirements in the 2020 Rule. The 

Agency did not propose to retain the 

regulatory text located at 

§ 121.7(e)(2)(iii) of the 2020 Rule, which 

required a certifying authority to 

describe specific water quality data or 


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information that would be needed if the 

denial is due to insufficient information. 

As discussed in the preamble to the 

proposed rule, the Agency noted that 

certifying authorities could provide this 

sort of information to satisfy the 

regulatory requirement at § 121.7(e)(2) 

to include a statement explaining why 

the certifying authority cannot certify 

that the activity as whole will comply 

with water quality requirements. 87 FR 

35353. However, some commenters 

argued that denials due to insufficient 

information should, as in the 2020 Rule, 

include an explanation of what 

information was missing. Although the 

Agency is not requiring any specific 

information for denials of certification, 

the Agency is adding language at final 

rule § 121.7(e)(3) to clarify that 

statements explaining why a certifying 

authority cannot certify that the activity 

will comply with water quality 

requirements may include, but are not 

limited to, a description of any missing 

water quality-related information if the 

denial is based on insufficient 

information. 

The Agency recommends including at 

least a succinct explanation for the 

certification denial to provide necessary 

transparency and clarity for project 

proponents and Federal agencies. As a 

practical matter, certifying authorities 

will likely already have developed and 

considered such information as part of 

their decision-making process and 

included it in the record to substantiate 

their decision. Aside from borrowing 

from their decision-making record, EPA 

expects that certifying authorities may 

be able to satisfy this requirement in 

several ways. For example, certifying 

authorities could identify specific water 

quality requirements with which the 

activity will not comply, or identify 

what information about the project or 

potential water quality effects is missing 

or incomplete that led the certifying 

authority to not be able to determine 

whether the activity will comply with 

water quality requirements. EPA 

anticipates that certifying authorities 

will work with project proponents and 

Federal agencies to determine what 

information would be most useful. 

Additionally, EPA is not distinguishing 

between certification decisions based on 

an individual or a general Federal 

license or permit. Although EPA took 

this approach in the 2020 Rule, EPA is 

no longer defining required certification 

decision-specific contents and the 

recommended contents would apply to 

a denial of certification regardless of the 

nature of the Federal license or permit. 

Lastly, EPA is finalizing that any 

express waiver made by a certifying 

authority should (1) identify the 

decision as an express waiver of 

certification, (2) identify the applicable 

Federal license or permit, (3) include a 

statement that the certifying authority 

expressly waives its authority to act on 

the request for certification, and (4) 

indicate that the certifying authority 

complied with its public notice 

procedures established pursuant to 

CWA section 401(a)(1). This approach is 

consistent with the 1971 Rule and 2020 

Rule, except the final rule merely 

recommends inclusion of such a 

statement of express waiver instead of 

requiring it. As noted above, an express 

waiver indicates only that the certifying 

authority has chosen not to act on a 

request for section 401 certification. 

Accordingly, the certifying authority 

would only need to state that it is 

waiving certification and would not 

need to make any statement about why 

it has decided to waive or its assessment 

of the project’s impact on its water 

quality. 

In this final rule, EPA is also, in large 

part, finalizing removal of 40 CFR 

124.53(e)(1) through (3), which address 

the contents of a certification for an 

EPA-issued NPDES permit. EPA 

proposed to delete of the entirety of 

§ 124.53. See 87 FR 35357. Most of the 

contents identified at § 124.53(e) are not 

consistent with the contents identified 

at § 121.7(d) and (e). For example, 

§ 124.53(e)(2) required a citation (but 

not an explanation) for each condition 

of certification, whereas final rule 

§ 121.7(e) recommends including an 

explanation (but not a citation) for each 

condition. Further, § 124.53(e)(1) 

identified what conditions must be 

included in a certification but did not 

match the conditions identified at final 

rule § 121.3(b). Final rule § 121.3(b) 

incorporates the final rule’s concepts of 

the entire ‘‘activity’’ scope of review and 

‘‘water quality requirements’’ while 

§ 124.53(e)(1) did not. To be clear, all 

certification decisions, including those 

on EPA-issued NPDES permits, must 

comply with this final rule § 121.3(b). 

As discussed above, certifying 

authorities may work with EPA and/or 

project proponents to determine what 

information would be most useful to 

include in a certification with 

conditions on an EPA-issued NPDES 

permit (e.g., a citation to the CWA or 

state law for conditions more stringent 

than those in the draft permit). 

EPA is finalizing revisions to 

§ 124.53(e)(3), now § 124.53(e), which 

allows, but does not require, certifying 

authorities to include a statement in a 

grant of certification regarding the 

extent to which each condition of the 

draft permit can be made less stringent 

without violating the requirements of 

state law, including water quality 

standards. EPA has concluded that this 

provision, as finalized, is not 

inconsistent with the Agency’s 

approach to certification decisions in 

the final rule because it is a 

recommended and not required 

component of a certification decision. 

This provision will assist the NPDES 

program in its implementation by 

ensuring that permit conditions in final 

NPDES permits are consistent with state 

law. However, any statement included 

pursuant to § 124.53(e) would be 

informational, for the benefit of EPA 

permit writers, and would not be a 

condition of certification. Section 

124.53(e) would not allow the Agency to 

reject or modify certification conditions; 

rather, this provision allows certifying 

authorities to provide EPA with input 

on draft permit conditions. This is not 

the only opportunity for a certifying 

authority to provide input on draft 

NPDES permit conditions. Certifying 

authorities could also provide input on 

draft NPDES permit conditions through 

the public notice process or upon 

review of a draft NPDES permit. 

3. Implementation 

A few commenters suggested that the 

definition of ‘‘to act’’ needed additional 

clarity to state the that the four actions 

proposed are the only ways in which a 

certifying authority may ‘‘act’’ on a 

request for certification. EPA finds that 

the regulatory text at final rule § 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. 


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79As discussed above, the Agency intends to 

include the recommended contents in certification 

decisions when it acts as a certifying authority and 

encourages other certifying authorities to include 

similar contents in their certification decisions. 

80See discussion in section IV.I of this preamble 

about ‘‘reopener’’ clauses or conditions and the 

Agency’s position on a certifying authority’s ability 

to unilaterally modify a certification after the 

reasonable period of time. 

As discussed above, EPA is not 

defining how exactly a certifying 

authority must indicate in its 

certification decision that it complied 

with public notice procedures. Instead, 

a certifying authority may choose how 

it wishes to demonstrate that it 

complied with its public notice 

procedures. Possible options include, 

but are not limited to, providing a copy 

of the public notice in its certification 

decision, describing in the certification 

decision the public notice process it 

undertook, checking a checkbox that 

indicates that the certifying authority 

complied with public notice 

procedures, or including an attestation 

statement that the certifying authority 

complied with its public notice 

procedures. 

Although the Agency is no longer 

requiring certifying authorities to 

include decision-specific contents in 

each of the four certification decisions, 

the Agency strongly encourages 

certifying authorities to include the 

recommended contents located at final 

rule § 121.7(c) through (f). EPA finds 

these recommended contents best reflect 

the types of information project 

proponents and Federal agencies may 

need to clearly understand and easily 

implement a certification decision. 

Specifically, clearly identifying the 

nature of the certification decision (i.e., 

a grant, grant with conditions, denial, or 

waiver) is an important way to promote 

transparency and to avoid 

misunderstandings. The Agency 

believes all recommended contents 

should be readily available to the 

certifying authority as part of its 

decision-making process, and therefore 

easily incorporated into a certification 

decision. 

The Agency received comments 

expressing concern over providing a 

justification statement for each 

certification condition because of 

readability concerns. To be clear, the 

Agency is not requiring these contents 

to be included in certification decisions, 

nor prescribing how they should be 

incorporated into a certification 

decision. Nevertheless, EPA believes 

there are several options to address such 

readability concerns and still provide 

the recommended information. For 

example, a certifying authority may 

choose to include explanations (e.g., 

statement, citations, etc.) immediately 

following the certification condition it 

supports. Alternatively, a certifying 

authority could organize those 

explanations in the form of a table and 

reference them in the document. Either 

of those methods is an acceptable way 

to provide the support for why the 

conditions are necessary. 

The recommended contents for 

certification decisions found at final 

rule § 121.7(c) through (f) do not 

represent the totality of information that 

a certifying authority may find useful to 

share with project proponents and 

Federal agencies.79 Certification 

decisions can act as important 

implementation tools for certifying 

authorities to convey best practices, 

rationales, and other pertinent 

information to both project proponents 

and Federal agencies. However, for 

certifications with conditions, it is 

important to clearly indicate what 

information is merely background or 

supplementary information as opposed 

to the actual conditions that must be 

incorporated into the Federal license or 

permit. For example, when EPA acts as 

the certifying authority it clearly 

denotes which aspects of the 

certification with conditions are general 

information versus the actual 

certification conditions. Clearly parsing 

out this information in the decision 

document ensures project proponents 

are best positioned to understand and 

comply with certification conditions. 

Related to the importance of clearly 

communicating certification decisions 

to project proponents and Federal 

agencies is the importance of drafting 

clear certification conditions. EPA 

recognizes that certification conditions 

are an important tool that enable 

certifying authorities to ensure that 

projects needing Federal licenses or 

permits will be able to move forward 

without adverse impacts to water 

quality. EPA encourages certifying 

authorities to develop certification 

conditions in a way that enables 

projects to adapt to future water qualityrelated 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 wishes to clarify the 

nature and effect of 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 change. 

Conversely, one commenter asserted 

that certifying authorities should not be 

able to add adaptive management 

conditions to certifications because such 

conditions are reopener conditions that 

could lead to new conditions being 

incorporated into the Federal permit 

long after the certification is issued. 

EPA agrees that adaptive management 

conditions are an important tool to 

enable a certification to assure that the 

project will comply with water quality 

activities over the life of the project. 

However, the Agency disagrees that 

these conditions are the same as 

‘‘reopener’’ clauses.80 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 

this 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 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 


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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, see supra). 

Once a certifying authority acts on a 

request for certification, the certifying 

authority should send the certification 

decision to the project proponent 

requesting certification. Ultimately, 

section 401(a)(1) requires the project 

proponent 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 email 

correspondence). 

G. Federal Agency Review 

1. What is the Agency finalizing? 

The Agency is finalizing regulatory 

text at § 121.8 to clarify that Federal 

agency review is limited to verifying 

compliance with the requirements of 

CWA section 401. Specifically, the final 

rule provides that to the extent a Federal 

agency verifies compliance with the 

requirements of CWA section 401, its 

review is limited to (1) whether the 

appropriate certifying authority issued 

the certification decision; (2) whether 

the certifying authority confirmed it 

complied with its public notice 

procedures established pursuant to 

section 401(a)(1); and (3) whether the 

certifying authority acted on the request 

for certification within the reasonable 

period of time. 40 CFR 121.8. EPA 

proposed at § 121.9 that Federal agency 

review of a certification decision is 

limited to confirming four factors: the 

nature of the decision, that the proper 

certifying authority issued the decision, 

that the certifying authority complied 

with its own public notice procedures 

for a request for certification, and that 

the decision was issued in the 

reasonable period of time. As discussed 

in more detail below, the Agency 

removed the first factor (the nature of 

the decision) and modified the third 

factor to clarify that Federal agency 

review is limited to verifying that the 

certifying authority confirmed 

compliance with its public notice 

procedures. Aside from the three 

elements listed at § 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). 

As proposed, the Agency is declining 

to define how a certifying authority 

must demonstrate its compliance with 

the three CWA section 401 requirements 

listed above. See 87 FR 35356 (June 9, 

2022). The Agency proposed at 

§ 121.9(b) to define a process that a 

Federal agency must follow if it 

determined that a certification decision 

did not indicate the nature of the 

certification decision or the certifying 

authority did not provide public notice 

on the request for certification. As 

discussed below, the Agency is not 

finalizing Federal agency review for 

whether the certification decision 

indicates the nature of the decision, and 

therefore EPA need not finalize a 

subsequent process. Although the final 

rule allows Federal agencies to verify 

that a certifying authority confirmed 

compliance with its public notice 

procedures, the Agency is returning to 

its pre-2020 Rule posture and declining 

to define a process that Federal agencies 

must follow if they are unable to verify 

compliance. The Agency is finalizing as 

proposed a process for the Federal 

agency to follow if it determines that a 

certifying authority failed or refused to 

act within the reasonable period of time 

at final rule § 121.9(b). Specifically, 

§ 121.9(b) requires the Federal agency to 

promptly notify the certifying authority 

and project proponent in writing that 

the certification requirement has been 

waived and that such notice from the 

Federal agency shall satisfy the project 

proponent’s obligation under CWA 

section 401. 

The Agency has also reorganized the 

regulatory text to move the Federal 

agency review provision to § 121.8, 

before the provision in the final rule 

regarding what it means to fail or refuse 

to act. The Agency believes this 

reorganization will more clearly 

communicate 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. 

The text as finalized 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. 

2. Summary of Final Rule Rationale and 

Public Comment 

Section 401 does not explicitly 

provide a defined role for Federal 

licensing or permitting agencies to 

review certifications. However, the 

Agency has long recognized, both in 

regulation and guidance, that some 

degree of Federal agency review of 

certification decisions is appropriate. 

The 1971 Rule provided Federal 

agencies with the ability to determine 

whether a certifying authority acted 

within the reasonable period of time. 

See 40 CFR 121.16(b) (2019) (‘‘The 

certification requirement with respect to 

an application for a license or permit 

shall be waived upon . . . Written 

notification from the licensing or 

permitting agency to the Regional 

Administrator of the failure of the State 

or interstate agency concerned to act on 

such request for certification within a 

reasonable period of time after receipt of 

such request . . .’’). Prior EPA guidance 

acknowledged that the Federal licensing 

or permitting agency may review the 

procedural requirements of a 

certification decision. 2010 Handbook at 

32 (rescinded in 2019, see supra) (‘‘For 

example, the federal permitting or 

licensing authority may review the 

procedural requirements of [section] 401 

certification, including whether the 

proper state or tribe has certified, 

whether the state or tribe complied with 

applicable public notice requirements, 

and whether the certification decision 

was timely.’’) (citing American Rivers, 

129 F.3d at 110–111; City of Tacoma v. 

FERC, 460 F.3d 53, 68 (D.C. Cir. 2006)). 

However, this prior guidance also 

acknowledged the limitations of Federal 

agency review and stated that Federal 

agencies cannot pick and choose among 

a certifying authority’s certification 

conditions. Id. at 10 (citing American 

Rivers, 129 F.3d at 110–11). 

A number of courts have 

acknowledged a limited role for Federal 

agencies to ensure that a certifying 

authority meets certain statutory 

requirements of section 401. The D.C. 

Circuit has held that section 401(a)(1) 

authorized FERC, as the relevant 

Federal licensing agency, ‘‘to determine 

that the specific certification ‘required 

by [section 401 has] been obtained,’ ’’ 

because otherwise, ‘‘without that 

certification, FERC lack[ed] authority to 

issue a license.’’ City of Tacoma, 460 

F.3d at 67–68 (‘‘If the question [raised 

to FERC] regarding the state’s section 

401 certification is not the application 

of state water quality standards but 

compliance with the terms of section 

401, then FERC must address it.’’). The 

court did not define what a 

‘‘certification required by this section’’ 

included, but suggested it included at a 

minimum, ‘‘explicit requirement[s] of 

section 401,’’ including that the 

certifying authority provide public 

notice, which was the section 401 

requirement at issue in the case before 


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81For the certification requests of both 

hydropower facilities, the certifying authority 

denied certification without prejudice to re-request 

certification within days of the expiration of the one 

year reasonable period of time. Id. The facilities rerequested certification and, about one year later, the 

certifying authority did so again. The certifying 

authority gave as the reason for denial that the 

project proponents had not completed the state 

environmental review process, which the certifying 

authority was required by law to consider in 

making its certification decision. Id. The Agency 

takes no position here regarding repeated denials 

without prejudice, generally for the same reasons as 

it is not taking a position regarding repeated 

withdrawal and resubmittals (e.g., the inquiry is 

highly fact specific and the caselaw is in flux). See 

section IV.D.2.c of this preamble. 

82The petitioners in the D.C. Circuit case 

petitioned the Supreme Court for certiorari but the 

Supreme Court denied the petition on April 17, 

2023. Turlock Irrigation District and Modesto 

Irrigation District v. FERC, et al., Docket No. 22– 

616. 

the court. Id. at 68. It is important to 

note that, while the court found that 

FERC had an obligation under the facts 

of that case to confirm the public notice 

requirement was satisfied, the court did 

not frame this requirement as a 

prerequisite in every instance where the 

agency is presented with a certification 

decision. Rather, the court found that 

FERC had to confirm compliance in the 

case before it because public notice had 

been ‘‘called into question.’’ See id. 

In an earlier case, the Second Circuit 

ruled that FERC did not have authority 

to substantively review certification 

conditions to ‘‘decide which conditions 

are within the confines of [section] 

401(d) and which are not.’’ American 

Rivers, 129 F.3d at 107. In reaching this 

conclusion, the court noted that FERC 

nonetheless did have authority to 

determine whether the appropriate 

certifying authority issued the 

certification decision and whether the 

certification decision was issued within 

the reasonable period of time. The court 

explained that ‘‘[w]hile [FERC] may 

determine whether the proper state has 

issued the certification or whether a 

state has issued a certification within 

the prescribed period, [FERC] does not 

possess a roving mandate to decide that 

substantive aspects of state-imposed 

conditions are inconsistent with the 

terms of [section] 401.’’ Id. at 110–11. 

In a more recent case, the D.C. Circuit 

upheld a FERC order declining to weigh 

in on the validity of a certifying 

authority’s denials of certification. 

Turlock Irrigation Dist. v. FERC, 36 

F.4th 1179 (D.C. Cir. 2022). At issue in 

the case was the re-licensing of two 

hydroelectric facilities. Id. at 1181. The 

hydroelectric facilities argued that the 

denials were invalid under the facts of 

the case.81 FERC found that no party 

disputed that the certifying authority 

denied the requests (without prejudice). 

Turlock Irrigation Dist. Modesto 

Irrigation Dist., 174 FERC ¶ 61,042, 

61,175 (2021). ‘‘FERC reasoned that the 

[certifying authority], ‘by denying the 

applications without prejudice, indeed 

acted on [ ] them. . . .’ ’’ Turlock, 36 

F.4th at 1182. FERC declined the 

facilities’ invitation to decide whether 

the denials where nonetheless somehow 

‘‘invalid’’ under Federal law ‘‘because 

they were ‘on non-substantive grounds’ 

and not ‘on the technical merits of the 

certification requests.’ ’’ Id. at 1182–83. 

FERC ‘‘conclude[d] that it is not the 

[FERC] Commission’s role to review the 

appropriateness of a state’s decision to 

deny certification.’’ 174 FERC at 

¶ 61,176. The Court of Appeals upheld 

FERC’s order.82 Turlock, 36 F.4th at 

1184. 

The 2020 Rule went a step further 

than the Federal agency review 

recognized by courts. The 2020 Rule 

required Federal agencies to review, in 

every instance, a certification decision 

to confirm that several requirements are 

met, including non-statutory 

requirements imposed by the 2020 Rule, 

as a prerequisite to accepting the 

certification decision. 85 FR 42267 (July 

13, 2020). The 2020 Rule required the 

Federal licensing agency to ensure (1) 

compliance with ‘‘other procedural 

requirements of section 401’’ (which 

included public notice requirements), 

(2) compliance with the reasonable 

period of time, and (3) compliance with 

the rule’s requirements related to 

providing a legal and technical basis 

within the certification document for 

the action taken. The 2020 Rule 

preamble explained that ‘‘[i]f a federal 

agency, in its review, determines that a 

certifying authority failed or refused to 

comply with the procedural 

requirements of the Act, including the 

procedural requirements of this final 

rule, the certification action, whether it 

is a grant, grant with conditions, or 

denial, will be waived.’’ Id. at 42266. 

The 2020 Rule took the same approach 

with review of individual conditions, 

i.e., if a condition does not meet 

procedural requirements, it is waived 

(even though the certification itself 

stands). Id. at 42263. The 2020 Rule did 

not extend Federal agency review to 

more substantive requirements of the 

Act (e.g., whether a certification 

decision was within the scope of 

certification). Id. at 42267. 

The 2020 Rule contained little 

direction to Federal agencies about how 

to conduct the required review (e.g., 

how to confirm public notice took 

place), other than noting in the 

preamble that the Federal agency’s 

review role does not require the agency 

to ‘‘make a substantive inquiry into the 

sufficiency of the information provided 

in support of a certification, condition, 

or a denial.’’ Id. at 42268. This lack of 

clarity in the 2020 Rule led to 

stakeholder confusion and 

misunderstanding about the nature of 

the Federal agency’s review (e.g., 

assertions from both Federal agencies 

and states and Tribes in 

implementation, pre-proposal input, 

and public comment that the review 

was to be ‘‘substantive’’ in nature). 

Additionally, although the 2020 Rule 

limited Federal agency review to certain 

procedural components, Federal agency 

stakeholders expressed concerns about 

being required by the 2020 Rule to 

undertake even this responsibility. 

Certifying authorities have expressed 

concern over the potential consequences 

of Federal agency review required by 

the 2020 Rule. A few commenters 

discussed their experience with the 

2020 Rule and Federal agency review, 

including specific examples where 

Federal agencies deemed certification 

decisions waived. Most commenters 

who discussed Federal agency review 

critiqued the 2020 Rule’s approach and 

argued that allowing, even requiring, 

Federal agencies to deem non-compliant 

certification decisions waived was 

inconsistent with the CWA and relevant 

case law (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 

asserted that the 2020 Rule provided 

Federal agencies with improper 

authority to ‘‘veto’’ or ‘‘override’’ 

certifying authorities’ decisions under 

the 2020 Rule. As discussed below, EPA 

generally agrees with these commenters. 

EPA continues to agree with the 

concerns it expressed in its Notice of 

Intent to revise the 2020 Rule, stating 

that ‘‘EPA is concerned that a federal 

agency’s review may result in a state or 

tribe’s certification or conditions being 

permanently waived as a result of 

nonsubstantive and easily fixed 

procedural concerns identified by the 

federal agency.’’ 86 FR 29543 (June 2, 

2021). 

The following subsections discuss the 

extent of Federal agency review, how 

certifying authorities might demonstrate 

compliance with the facial requirements 

of section 401, and the Federal agency 

review process under this final rule. 

a. Extent of Federal Agency Review 

The final rule confirms that Federal 

agencies may review a certification 

decision only for the limited purpose of 

verifying compliance with the 

requirements of CWA section 401. EPA 


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proposed at § 121.9 that Federal agency 

review of a certification decision is 

limited to confirming four factors: the 

nature of the decision, that the proper 

certifying authority issued the decision, 

that the certifying authority provided 

public notice on the request for 

certification, and that the decision was 

issued in the reasonable period of time. 

As discussed in more detail below, the 

Agency removed the first factor (the 

nature of the decision) and modified the 

third factor to clarify that Federal 

agency review is limited to verifying 

that the certifying authority confirmed 

compliance with its public notice 

procedures. 

As a result, the final rule provides 

that Federal agencies may verify (1) 

whether the appropriate certifying 

authority issued the certification 

decision, (2) whether the certifying 

authority confirmed it complied with its 

public notice procedures established 

pursuant to section 401(a)(1), and (3) 

whether the certifying authority acted 

on the request for certification within 

the reasonable period of time. 40 CFR 

121.8. Federal agencies may find that a 

certifying authority waived its ability to 

act on a request for certification only for 

failures to act within the reasonable 

period of time. The Agency finds this 

Federal agency review role is reasonable 

and consistent with the text of section 

401, prior Agency guidance, and case 

law. 

A Federal agency’s review of a 

certifying authority’s action (to ensure 

that the certification decision meets 

certain statutory requirements) does not 

require a Federal agency to inquire as to 

whether the certification is consistent 

with the substantive elements of state or 

Tribal law concerning certification or 

whether the certification action is 

within the proper ‘‘scope of 

certification.’’ As recognized by prior 

Agency guidance and the 2020 Rule, 

section 401 does not authorize Federal 

agencies to review or change the 

substance of a certification (e.g., 

determine whether the certification or 

its conditions are within section 401’s 

scope). See 85 FR 42268; 2010 

Handbook at 10 (rescinded in 2019, see 

supra). As discussed below, the Agency 

has revised the proposed regulatory text 

to better emphasize the limited extent of 

Federal agency review. 

Several commenters noted that 

section 401 does not give Federal 

agencies the authority to nullify or reject 

a certifying authority’s water quality 

certification or conditions. Some of 

these commenters asserted that courts 

have affirmed that Federal agencies do 

not have the authority to ignore 

conditions of certification. EPA agrees. 

Federal circuit courts have routinely 

held that Federal agencies may not 

question or criticize the substance of a 

state’s water quality certification or 

conditions, see, e.g., City of Tacoma, 

460 F.3d at 67 (‘‘[The Federal agency’s] 

role is limited to awaiting, and then 

deferring to, the initial decision of the 

state.’’); American Rivers, 129 F.3d at 

111 (‘‘[The Federal agency] does not 

possess a roving mandate to decide that 

substantive aspects of state-imposed 

conditions are inconsistent with the 

terms of [section] 401.’’); U.S. Dept. of 

Interior v. FERC, 952 F.2d 538, 548 (D.C. 

Cir. 1992) (‘‘FERC may not alter or reject 

conditions imposed by the states 

through section 401 certificates.’’). 

Courts have also cautioned Federal 

agencies against imposing conditions in 

a Federal license or permit they believe 

are more stringent than the certifying 

authority’s conditions. See Sierra Club 

v. U.S. Army Corps of Eng’rs, 909 F.3d 

635, 648 (4th Cir. 2018) (‘‘the plain 

language of the Clean Water Act does 

not authorize the Corps to replace a 

state condition with a meaningfully 

different alternative condition, even if 

the Corps reasonably determines that 

the alternative condition is more 

protective of water quality’’); see also 

Lake Carriers’ Ass’n. v. EPA, 652 F.3d 

1, 6, 12 (D.C. Cir. 2011) (concluding that 

additional notice and comment on state 

certification conditions would have 

been futile because ‘‘the petitioners 

have failed to establish that EPA can 

alter or reject state certification 

conditions . . .’’). 

Rather, 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 the decision was 

issued within the reasonable period of 

time, whether public notice procedures 

were followed, and whether the 

appropriate certifying authority issued 

the decision. The court in City of 

Tacoma found that if the facial public 

notice requirement of section 401 is 

‘‘called into question’’ before the 

Federal agency, the Federal agency must 

determine if it was met. 460 F.3d at 68 

(requiring the Federal agency ‘‘to obtain 

some minimal confirmation of such 

compliance, at least in a case where 

compliance has been called into 

question.’’). 

EPA proposed to expressly limit 

Federal agency review at § 121.9 to 

confirming four factors: the nature of the 

decision, that the proper certifying 

authority issued the decision, that the 

certifying authority provided public 

notice on the request for certification, 

and that the decision was issued in the 

reasonable period of time. Several 

commenters agreed with limiting the 

2020 Rule’s breadth of Federal agency 

review, with some of these commenters 

supporting all four of the proposed 

review provisions. A few commenters 

wrote in favor of the proposed rule’s 

limited ‘‘ministerial’’ role for Federal 

agencies. EPA agrees that Federal 

agency review is limited in nature. As 

discussed below, the Agency is 

finalizing regulatory text at § 121.8 to 

affirmatively limit Federal agency 

review to verifying compliance with the 

facial requirements of CWA section 401. 

However, 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. 

Conversely, a few commenters 

recommended prohibiting Federal 

agency review of any certification 

decisions in the final rule, with one 

commenter arguing that Federal agency 

review erodes cooperative federalism 

principles, and another 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. 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. 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 

above, 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. 

On the other hand, other commenters 

wrote in support of the 2020 Rule’s 

approach to Federal agency review, 

arguing 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 


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83 In Keating v. FERC, the court required FERC to 

consider the application of section 401(a)(3) to a 

certifying authority’s purported revocation of a 

certification. 927 F.2d 616 (D.C. Cir. 1991) (‘‘FERC 

must at least decide whether the state’s assertion of 

revocation satisfies section 401(a)(3)’s predicate 

requirements—i.e., whether it is timely and 

motivated by some change in circumstances after 

the certification was issued.’’). 

disincentivized—to provide information 

supporting their certification actions. A 

few commenters argued that the 2020 

Rule’s approach to Federal agency 

review was a less costly and more 

efficient mechanism than judicial 

review. 

EPA declines to impose in this final 

rule a requirement that Federal agencies 

review every certification decision for 

compliance with the statutory 

requirements of section 401. EPA 

recognizes that the preamble to the 2020 

Rule indicated that Federal agency 

review is mandatory in every instance. 

85 FR 42267–69 (‘‘the Agency has 

concluded that under the final rule, 

federal agencies have an affirmative 

obligation to review certifications to 

ensure that certifying authorities have 

complied with procedural requirements 

and have included the required 

information for certifications, 

conditions, and denials . . .’’). 

However, most case law on this topic 

focuses on the extent of Federal agency 

review, not the issue of if or when 

section 401 imposes a duty on the 

Federal agency to confirm compliance. 

The exception to courts not addressing 

this issue is City of Tacoma, where the 

court found that if the public notice 

requirement of section 401 is ‘‘called 

into question’’ before the Federal 

agency, the agency must determine if it 

was met. 460 F.3d at 68.83 This final 

rule does not address what 

circumstances might compel a Federal 

agency to review certification decisions, 

nor does it require Federal agencies to 

review every certification decision. 

Instead, this final rule allows Federal 

agencies to review specified aspects of 

a certification decision, recognizing that 

Federal agencies have an interest in 

ensuring certifications relating to their 

permits are facially compliant with 

CWA section 401. 

The Agency also disagrees with 

commenter assertions that the Agency is 

removing Federal oversight. The Agency 

is still authorizing Federal agencies to 

review much of what they could under 

the 2020 Rule. In fact, the Agency is 

clarifying in regulatory text that Federal 

agency review includes verification that 

the certifying authority confirmed that it 

complied with its public notice 

procedures and that the correct 

certifying authority acted on the request 

for certification (aspects that were not 

directly addressed in the 2020 Rule). 

The one aspect of the 2020 Rule that the 

Agency is removing is Federal agency 

review of the procedural and 

informational requirements (e.g., 

citation requirements) of the 2020 Rule 

(as opposed to the facial requirements of 

section 401). The Agency disagrees with 

commenters who argued that this will 

lead to a lack of supporting information 

in certification decisions or create a 

structure for misuse. EPA encourages 

certifying authorities to include 

supporting information with 

certification decisions and is finalizing 

this recommendation at § 121.7. 

Furthermore, it is in the certifying 

authority’s interest to include such 

information to ensure project 

proponents and Federal agencies—not 

to mention any court reviewing the 

certification decision—understand why 

a condition is placed on a certification 

or why a certification is being denied. 

See supra section IV.F of this preamble 

for further discussion of the contents of 

a certification decision. 

It is unclear why some commenters 

concluded that the 2020 Rule’s Federal 

agency review process would reduce 

litigation or create any efficiencies when 

compared to direct judicial review. 

Those commenters did not provide any 

data or information to substantiate a 

time or cost differential between the 

2020 Rule’s Federal agency review 

process and any possible judicial review 

associated with certification decision. 

Nothing about the 2020 Rule’s approach 

to Federal agency review removed or 

reduced the opportunity or potential for 

judicial review on a certification 

decision. In fact, the 2020 Rule’s 

mandate that Federal agencies review 

for compliance with the rule’s own 

procedural and informational 

requirements (e.g., citation 

requirements) added another possible 

avenue for judicial review. Federal 

courts could be called upon to decide 

whether a Federal agency properly 

found that a certifying authority waived 

certification for its failure to fully 

comply with the 2020 Rule’s 

informational requirements. In fact, one 

such case was recently filed in the D.C. 

Circuit Court of Appeals. Brookfield 

White Pine Hydro LLC v. FERC, No. 23– 

1075 (D.C. Cir.) (petition for review filed 

March 20, 2023, regarding FERC 

determination that a denial of 

certification satisfied the procedural 

requirements of the 2020 Rule). 

Furthermore, Federal agency review 

of the substance of certification 

decisions in lieu of judicial review is 

inconsistent with the legislative history 

of section 401. Indeed, 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. 91–940, 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.’’). 

The Agency is finalizing regulatory 

text substantively similar to proposed 

§ 121.9(a)(2) that allows a Federal 

agency to verify whether the appropriate 

certifying authority—meaning the entity 

responsible for certifying compliance 

with applicable water quality 

requirements where the discharge 

originates or will originate—issued the 

certification decision. 40 CFR 121.8. 

EPA made one non-substantive change 

to proposed text to verify whether the 

‘‘appropriate’’, as opposed to ‘‘proper’’, 

certifying authority issued the 

certification decision. 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). If the project 

proponent provides the Federal agency 

with a certification from the wrong 

certifying authority, then the Federal 

agency cannot issue its license or 

permit. Allowing a Federal agency to 

confirm that the appropriate certifying 

authority has issued certification is 

consistent with case law, American 

Rivers, 129 F.3d at 110–11, and prior 

Agency regulations and guidance, 85 FR 

42267; 2010 Handbook at 10 (rescinded 

in 2019, see supra). 

The Agency is finalizing regulatory 

text that allows a Federal agency to 

verify that the certifying authority 

confirmed it complied with its public 

notice procedures established pursuant 

to section 401(a)(1). 40 CFR 121.8. EPA 

proposed that a Federal agency may 

review a certification decision to 

determine whether the certifying 

authority ‘‘provided public notice’’ on 

the request for certification at 

§ 121.9(a)(3). Some commenters noted 


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that public notice procedures vary 

amongst certifying authorities, 

including one commenter that noted 

that establishing generally applicable 

procedures for public notice is not 

necessarily the same as providing public 

notice on every application. EPA agrees 

with these commenters. 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). Accordingly, EPA 

has revised the regulatory text, now 

located at § 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. 

One commenter 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. 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 

authorized 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 its certification decision. 

See section IV.F of this preamble for 

further discussion on ways a certifying 

authority can indicate its compliance; 

see also infra. 

The Agency is also finalizing 

regulatory text substantively similar to 

proposed § 121.9(a)(4) that allows a 

Federal agency to verify whether a 

certifying authority acted on a request 

for certification within the reasonable 

period of time. 40 CFR 121.8. Section 

401 provides that certification ‘‘shall be 

waived’’ if the certifying authority fails 

or refuses to act within the reasonable 

period of time. A Federal agency cannot 

issue its license or permit until 

certification ‘‘has been obtained or has 

been waived.’’ 33 U.S.C. 1341(a)(1). It is 

thus reasonable for the Federal agency 

to determine whether a certifying 

authority acted within the reasonable 

period of time, and this has been the 

Agency’s longstanding position in 

regulation and guidance. See 40 CFR 

121.16(b) (2019); 85 FR 42267; 2010 

Handbook at 10 (rescinded in 2019, see 

supra). Additionally, as discussed 

above, this is also consistent with case 

law on Federal agency review. See 

American Rivers, 129 F.3d at 110–11 

(explaining that FERC ‘‘may determine 

. . . whether a state has issued a 

certification within the prescribed 

period’’); see also Alcoa Power 

Generating, 643 F.3d at 972–73 (holding 

that, like the public notice requirements 

at issue in City of Tacoma, the issue of 

whether a certifying authority acted 

upon a certification request within the 

statutory one-year period was an issue 

properly before FERC). 

The Agency is not finalizing the 

regulatory text proposed at § 121.9(a)(1), 

which provided that a Federal agency 

may also review a certification decision 

to confirm the nature of the decision 

(i.e., 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 § 121.8. The 

other components all concern verifying 

compliance with the statutory 

requirements of section 401. EPA 

concludes that it is best to remove this 

provision to avoid confusion. Further, 

as one commenter noted, the decision 

should generally be apparent on its face. 

Certifying authorities and Federal 

agencies have over 50 years of 

experience with developing and 

receiving certification decisions, 

respectively. Additionally, the Agency 

is finalizing regulatory text at § 121.7(a) 

that clearly defines the four possible 

ways a certifying authority may act on 

a request for certification, as well as 

regulatory text at § 121.7(c) through (f) 

that clearly outlines recommended 

contents for a certification decision. 

These final rule provisions should 

provide certifying authorities with 

sufficient clarity regarding possible 

actions they may take and how to 

develop clear certification decisions. 

b. Demonstrating Compliance With the 

Facial Requirements of Section 401 

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. 

At proposal, EPA did not define the 

specific information a certifying 

authority must include in its 

certification decision to demonstrate 

that it has met the facial requirements 

of section 401. However, EPA requested 

comment on whether the Agency should 

identify in regulation different elements 

of a certification decision that might be 

appropriate for Federal agency review, 

or whether EPA should defer to Federal 

agencies to define those elements. 

In the final rule, the Agency is 

declining to define the specific 

information a certifying authority must 

include in a certification decision to 

demonstrate that it has met the facial 

requirements of section 401. 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 expects 

that it should only take minimal effort 

by a certifying authority to demonstrate 

compliance for Federal agency 

verification. However, as discussed 

below, the Agency is providing 

recommendations for how certifying 

authorities can demonstrate compliance 

with these requirements. 

To support a streamlined review of 

whether a certifying authority complied 

with its public notice procedures, EPA 

is finalizing a recommendation for a 


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84See section IV.F of this preamble regarding 

contents of certification decisions. 

85But see section IV.H of this preamble for further 

discussion on instances where EPA acts as the 

certifying authority instead of a state or authorized 

Tribe. 

certifying authority to indicate such 

compliance in its certification 

decision.84 By doing so, the Federal 

agency should be able to simply look at 

the certification decision and quickly 

and easily determine whether the 

certifying authority indicated that it 

followed its public notice procedures. 

A few commenters discussed how 

certifying authorities currently, or 

could, demonstrate compliance with 

their public notice procedures, 

including 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. EPA finds that 

these and other approaches to 

demonstrating compliance with public 

notice procedures would be 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. This inquiry does not 

require the Federal agency to research or 

inquire about the particulars of a state 

or Tribal laws and regulations regarding 

public notice, but rather merely verify 

that the certifying authority confirmed it 

complied with its public notice 

procedures. EPA is not defining how a 

certifying authority must communicate 

such confirmation, but EPA does not 

anticipate that such demonstrations will 

be burdensome. As the court noted in 

City of Tacoma, Federal agencies only 

need ‘‘to obtain some minimal 

confirmation of such compliance.’’ 460 

F.3d at 68. 

The Agency is also not defining how 

a certifying authority must demonstrate 

that it provided a certification decision 

within the reasonable period of time. 

However, EPA finds that other 

provisions in this final rule should aid 

in making such a demonstration. For 

example, final rule § 121.6(a) requires a 

certifying authority to send the project 

proponent and the Federal agency a 

written confirmation of the date that the 

request for certification was received, 

while § 121.6(b) requires the Federal 

agency and certifying authority to 

jointly agree on the reasonable period of 

time in writing. Using this 

documentation, the Federal agency 

should be able to verify whether the 

certifying authority acted on the request 

for certification within the reasonable 

period of time. If the Federal agency 

needs further information to verify that 

the certification decision was issued 

within the reasonable period of time, 

the certifying authority could satisfy 

this inquiry by providing 

documentation of the date it furnished 

the project proponent with a decision. 

The Agency is also not defining how 

to demonstrate that the certification is 

from the appropriate certifying 

authority, meaning the state or 

authorized Tribe responsible for 

certifying compliance with applicable 

water quality requirements where the 

discharge originates or will originate.85

EPA finds that the project proponent 

bears the burden of demonstrating that 

it has obtained a certification from the 

appropriate certifying authority. See 33 

U.S.C. 1341(a)(1) (‘‘Any applicant . . . 

shall provide the licensing or permitting 

agency a certification from the State in 

which the discharge originates or will 

originate . . .’’). Accordingly, if a 

Federal agency chooses to verify that the 

appropriate certifying authority issued 

the certification decision, it should 

work with the project proponent to 

obtain location information, such as a 

map, indicating where the discharge 

originates or will originate. The Federal 

agency and project proponent may also 

discuss any questions regarding 

jurisdiction with the certifying 

authority, or as needed, EPA in its 

technical assistance capacity under 

section 401(b). 

c. Federal Agency Review Process 

Consistent with the 1971 Rule and 

2020 Rule, the Agency is finalizing 

regulatory text to reaffirm that a waiver 

of certification occurs only if the 

certifying authority fails to act within 

the reasonable period of time. See 40 

CFR 121.9(a)(2)(i) (2020); 40 CFR 

121.16(b) (2019). If the Federal agency 

reviews for timeliness and determines 

that the reasonable period of time has 

passed without the certifying authority 

acting on the request for certification, 

then the Federal agency may determine 

that a constructive waiver has occurred. 

40 CFR 121.9(b). Similar to the 

approach in the 2020 Rule, the Agency 

is finalizing regulatory text describing 

how the Federal agency must 

communicate its waiver determination 

to the project proponent and certifying 

authority. See id. Specifically, 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. Id. Similar to the 2020 Rule, 

see § 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 § 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 

§ 121.12). However, as discussed in 

more detail below, 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. 

Many commenters agreed with the 

proposal’s characterization of 

constructive waiver as a ‘‘severe 

consequence.’’ Some commenters 

expressed support for the position in the 

proposal that constructive waiver may 

only occur 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. A few commenters stated that 

procedural technicalities should not be 

a basis for an involuntary or implicit 

waiver of certification. 

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 this 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 


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86Nothing in section 401 precludes a Federal 

licensing or permitting agency from considering 

input provided by a state or authorized Tribe in a 

late certification decision. But that consideration 

would occur outside the context of section 401 and 

would be akin to consideration of input provided 

by the state or Tribe in any other context (e.g., a 

public comment period). For example, if a 

certifying authority included conditions in a late 

certification, nothing in section 401 precludes the 

Federal licensing or permitting agency from 

considering including similar conditions in its 

Federal license or permit, even though section 401 

would not compel the Federal agency to do so. 

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).86

A couple of commenters suggested 

that EPA require the Federal agency to 

extend the reasonable period of time in 

instances where the certifying authority 

failed to act and extending the 

reasonable period of time would not 

exceed the one-year statutory time 

period from receipt of the request for 

certification. These commenters 

asserted that allowing constructive 

waiver before one year would be 

inconsistent with cooperative 

federalism principles, and one of these 

commenters asserted that section 

401(a)(1) prohibited a finding of a 

constructive waiver until after one year. 

Conversely, one commenter expressed 

concern over the proposal’s preamble 

language encouraging Federal agencies 

to extend the reasonable period of time 

where a certifying authority 

inadvertently waives certification, 

asserting that section 401 clearly 

provides that if a reasonable period of 

time is established and 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. 

Aside from providing that a waiver 

occurs if the certifying authority does 

not act within the reasonable period of 

time, the statute does not provide 

direction on what should occur if a 

certifying authority fails to meet the 

other statutory requirements in section 

401. As discussed earlier, the legislative 

history indicates that Congress added 

the waiver provision to prevent ‘‘sheer 

inactivity’’ by a certifying authority 

from holding up the licensing or 

permitting process. See H.R. Rep. No. 

91–940, at 54–55 (March 24, 1970) 

(Conf. Report). Consistent with the 

statutory language and legislative 

history, EPA believes that Congress 

intended such an extreme outcome only 

in situations where certifying 

authorities fail or refuse to make a 

decision, and not where a certifying 

authority, otherwise attempting to make 

a timely decision, fails to comply with 

other requirements of section 401. Case 

law also provides support for the 

Federal agency allowing the certifying 

authority to either demonstrate that its 

decision meets section 401’s 

requirements or remedy the situation, as 

opposed to the Federal agency having 

authority to deem any failure an 

automatic waiver of certification. See 

City of Tacoma, 460 F.3d at 68–69 

(‘‘FERC should seek an affirmation from 

Ecology that it complied with state law 

notice requirements when it issued its 

water quality certification or, if it did 

not, that it has done so in response to 

this decision.’’). 

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. Most commenters 

providing input on this topic expressed 

support for proposed § 121.9(b) that if 

the Federal licensing or permitting 

agency determines that certain statutory 

requirements (e.g., public notice) have 

not been met, it must provide the 

certifying authority with an opportunity 

to remedy the situation. However, a few 

commenters expressed concern with the 

proposed automatic extensions for 

certifying authorities that failed to 

comply with public notice procedures, 

suggesting that it might incentivize 

certifying authorities to ignore 

procedures and improperly extend the 

time for certification. 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 further detail below, this restores the 

Agency’s pre-2020 Rule approach to 

Federal agency review and avoids 

unnecessarily encumbering the 

certification process with more 

procedure. 

The Agency proposed at § 121.9(b) 

that if a Federal agency determines that 

a section 401 certification decision does 

not clearly indicate whether it is a grant, 

grant with conditions, denial, or express 

waiver, the Federal agency must notify 

the certifying authority of the deficiency 

and provide the certifying authority 

with an opportunity to remedy it. As 

discussed above, the Agency is not 

finalizing regulatory text regarding 

Federal agency review of the nature of 

the certification decision, so the 

proposed text regarding next steps is no 

longer needed. 

The Agency did not propose any 

regulatory text explicitly discussing the 

consequences or next steps where 

Federal agency review reveals that the 

wrong certifying authority provided the 

certification decision. However, the 

proposed rule preamble provided that if 

Federal agency discovers that the wrong 

certifying authority issued the 

certification, then the Federal agency 

should notify the project proponent that 

it must seek certification from the 

appropriate certifying authority before 

the Federal license or permit may be 

issued. The Agency is not including 

regulatory text regarding next steps for 

this aspect of Federal agency review, but 

continues to encourage the Federal 

agency to promptly notify the project 

proponent where the Federal agency 

determines that the certification 

decision was not issued by the 

appropriate certifying authority. As 

noted above, section 401 requires a 

project proponent to seek certification 

from the jurisdiction in which the 

discharge originates or will originate. 33 

U.S.C. 1341(a)(1). Therefore, it is 

incumbent on the project proponent to 

identify and obtain certification (or 

waiver) from the proper certifying 

authority—the entity responsible for 

certifying compliance with applicable 

water quality requirements where the 

discharge originates or will originate— 

before it can obtain a Federal license or 

permit. See 40 CFR 121.1(b). 

The Agency is not finalizing the 

process proposed at § 121.9(b) for the 

Federal agency to follow if it is unable 

to obtain confirmation from the 

certifying authority that the certifying 

authority complied with its public 

notice procedures. The Agency 

proposed that the Federal agency must 

notify the certifying authority if it 

determined that the certifying authority 

did not provide public notice on the 

request for certification and provide the 

certifying authority with an opportunity 

to remedy the noted deficiency. 87 FR 

35357. The proposal further provided 

that, if necessary, the Federal agency 

must extend the reasonable period of 

time to provide the certifying authority 

with an opportunity to remedy the 

deficiency, but the reasonable period of 

time may not exceed one year from the 

receipt of the certification request. Id. 

Most commenters providing input on 

this aspect of the proposed rule 

expressed support for Federal agencies 

extending the reasonable period of time 

to allow for correction of deficiencies up 

to the statutory one-year limit. A few 

commenters suggested that the final rule 

should allow certifying authorities to 


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correct errors even after the reasonable 

period of time has ended, including one 

commenter who suggested it should 

extend beyond the one-year timeframe. 

Conversely, 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. 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. 

The Agency is declining to define any 

specific process to remedy any 

deficiencies identified through Federal 

agency review. As an initial matter, the 

Agency did not provide a regulatory 

process for Federal agency review prior 

to the 2020 Rule (aside from failure or 

refusal to act within the reasonable 

period of time). Rather, prior EPA 

guidance merely acknowledged that the 

Federal licensing or permitting agency 

may review the procedural requirements 

of a certification decision. See 2010 

Handbook at 32 (rescinded in 2019, see 

supra) (‘‘For example, the federal 

permitting or licensing authority may 

review the procedural requirements of 

[section] 401 certification, including 

whether the proper state or tribe has 

certified, whether the state or tribe 

complied with applicable public notice 

requirements, and whether the 

certification decision was timely.’’) 

(citing American Rivers, 129 F.3d at 

110–111; City of Tacoma v. FERC, 460 

F.3d 53, 68 (D.C. Cir. 2006)). The 

Agency is not aware of any issues, 

procedural or otherwise, with Federal 

agencies and certifying authorities 

managing this process pre-2020 Rule. 

Because this final rule returns the 

Agency to its pre-2020 Rule posture on 

Federal agency review, the Agency is 

accordingly declining to define a 

process to address deficiencies 

identified through Federal agency 

review. The Agency expects this will 

provide certifying authorities and 

Federal agencies with the flexibility to 

address such procedural deficiencies in 

accordance with pre-2020 Rule 

practices. 

The Agency emphasizes that other 

aspects of this final rule should prevent 

the need for specific EPA-mandated 

process to remedy deficiencies 

identified through Federal agency 

review. First, as discussed in section 

IV.D of this preamble, certifying 

authorities have an active role in setting 

the reasonable period of time with the 

Federal agency. See 40 CFR 121.6(b). 

This approach provides certifying 

authorities with an opportunity to 

ensure the length of the reasonable 

period of time considers their specific 

timing needs and concerns. Second, the 

final rule provides certifying authorities 

and Federal agencies with the ability to 

extend the reasonable period of time as 

needed, or automatically in limited 

cases. See 40 CFR 121.6(d) and (e). 

Together, these components of the final 

rule should provide certifying 

authorities with ample opportunities to 

ensure they have the appropriate 

amount of time to act on a request for 

certification and comply with the facial 

components of section 401. EPA notes 

that its proposed automatic extensions 

for curing deficiencies (at proposed 

§ 121.9(b)) would have applied only for 

failure to indicate the nature of the 

decision and failure to provide public 

notice. In this final rule, EPA has 

removed Federal agency review of the 

nature of the decision and expressly 

limited review of public notice to 

simply verifying that the certifying 

authority confirmed that it complied 

with its public notice procedures. 

Additionally, as discussed in section 

IV.F of this preamble, the Agency 

encourages certifying authorities to 

include an indication that they 

complied with their public notice 

procedures established in all 

certification decisions. This serves two 

purposes. First, it ensures the certifying 

authority remains cognizant of 

satisfying all statutory requirements in 

section 401, including the need to 

establish and comply with public notice 

procedures. Second, it clearly 

communicates the certifying authority’s 

compliance with this requirement of 

section 401 so that in the event the 

Federal agency chooses to review for 

such compliance it may easily 

determine that the certifying authority 

confirmed compliance with its public 

notice procedures. 

3. Implementation 

As discussed throughout this 

preamble, EPA emphasizes the 

importance of communication between 

certifying authorities, Federal agencies, 

and project proponents early and often 

through the certification process. 

Consistent communication can ensure 

that stakeholders develop a common 

understanding around timing and 

information needs to complete the 

certification process and comply with 

the facial requirements of section 401. 

Ideally, such communication minimizes 

the need for Federal agency review. 

However, in the event a Federal agency 

reviews a certifying authority’s action, it 

is limited to reviewing whether the 

action complies with the requirements 

of section 401 as explicitly defined at 

final rule § 121.8. Federal agency review 

does not require, nor allow, a Federal 

agency to review the substance of a 

certification decision or specific 

certification condition (e.g., determine 

whether the certification or its 

conditions is within the scope of section 

401). 

In the proposal, EPA requested 

comment on whether the Agency should 

develop procedures regarding how a 

certifying authority should respond to a 

Federal agency’s notice regarding 

deficiencies in its certification decision. 

Several commenters provided various 

recommendations on the procedural 

aspects of the Federal agency review 

process, including recommending that 

the final rule should require the Federal 

agency to immediately notify the 

certifying authority after a deficiency 

was identified, recommending that 

Federal agencies develop procedures 

providing how a certifying authority 

should respond to a Federal agency’s 

notice regarding deficiencies, and 

suggesting that the final rule include 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 Federal 

license or permit. 

Under this final rule, if the Federal 

agency determines that the certifying 

authority did not act on a request for 

certification within the reasonable 

period of time, then the final rule 

requires the Federal agency to promptly 

notify the certifying authority and 

project proponent in writing that the 

certification requirement has been 

waived. 40 CFR 121.9(b). This final rule 

does not require a Federal agency to 

notify the certifying authority an 

impending deadline to act on a 

certification request prior to finding 


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waiver for failing or refusing to act. 

Certifying authorities are ultimately 

responsible for managing resources and 

ensuring that they act on a request for 

certification within the reasonable 

period of time. However, the Agency 

encourages Federal agencies to reach 

out to certifying authorities to remind 

them of impending deadlines to act 

prior to finding constructive waiver, or 

setting up MOAs or other agreements to 

establish notification protocols prior to 

finding a waiver of certification. 

EPA encourages Federal agencies to 

promptly notify certifying authorities if 

they are seeking confirmation of 

certifying authority compliance with 

public notice procedures, and to 

promptly notify project proponents if 

they determine the certification decision 

was not issued by the appropriate 

certifying authority. In either event, the 

final rule does not define the contents 

of such notification, but EPA encourages 

Federal agencies to provide notification 

in writing so the certifying authority 

and/or project proponent can respond 

accordingly. 

EPA does not find it necessary to 

impose a regulatory requirement for the 

Federal agency to notify the certifying 

authority that the certification has been 

received within the reasonable period of 

time, and that the certification 

conditions have been incorporated into 

the relevant Federal license or permit. 

As discussed above, Federal agency 

review is not a mandatory requirement 

under this final rule. The certifying 

authority should know whether it has 

issued its decision in the reasonable 

period of time due to its involvement in 

setting the reasonable period of time. As 

long as the certifying authority provides 

its certification decision within the 

reasonable period of time, the Federal 

licensing or permitting agency is 

required to incorporate any certification 

conditions into its license or permit. See 

33 U.S.C 1341(d). 

H. EPA’s Roles Under Section 401 

1. What is the Agency finalizing? 

Under section 401, EPA serves three 

different roles. First, 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). Second, EPA is also 

responsible for providing technical 

assistance upon request from Federal 

agencies, certifying authorities, or 

Federal license or permit applicants. Id. 

at 1341(b). Lastly, EPA is responsible for 

notifying other states or authorized 

Tribes that may be affected by a 

discharge from a federally licensed or 

permitted activity, and where required, 

for providing an evaluation and 

recommendations on such notified state 

or authorized Tribe’s objections. Id. at 

1341(a)(2). This section focuses on 

EPA’s role as a certifying authority and 

in providing technical assistance. The 

Agency’s third role under section 

401(a)(2), or the neighboring 

jurisdictions process, is discussed in 

section IV.K in this preamble. 

Consistent with the proposal, the 

Agency is finalizing revisions to the 

regulatory text at §§ 121.16 and 121.17 

to clarify EPA’s process when it acts as 

the certifying authority, such as 

updating its public notice and hearing 

provisions. More specifically, the 

Agency is finalizing that when EPA is 

the certifying authority, it must provide 

public notice within 20 days of the date 

the request for certification is received. 

40 CFR 121.17(a). The final rule also 

states that when EPA acts as the 

certifying authority, it is subject to the 

same requirements as other certifying 

authorities. EPA is also finalizing the 

regulatory text on EPA’s technical 

assistance role at § 121.18 which reflects 

the statutory text at section 401(b) more 

directly. 

2. Summary of Final Rule Rationale and 

Public Comment 

a. EPA’s Role as a Certifying Authority 

EPA is finalizing revisions to the part 

121 regulations to provide greater clarity 

about EPA’s process when it acts as the 

certifying authority. 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). The 1971 Rule required EPA 

to provide certification in two scenarios: 

first, where EPA promulgated standards 

pursuant to section 10(c)(2) of the 1970 

Water Quality Improvement Act; and 

second, where water quality standards 

had been established, but no state or 

interstate agency had authority to 

provide certification. 40 CFR 121.21 

(2019). As discussed in section III in 

this preamble, the 1971 Rule was 

promulgated prior to the enactment of 

the 1972 CWA amendments; as a result, 

the language in the 1971 Rule regarding 

EPA as a certifying authority did not 

reflect the amended text of section 401. 

In the 2020 Rule, EPA updated this 

provision with new regulatory text that 

indicated that EPA provides 

certification consistent with the 1972 

statutory text and noted that EPA was 

required to comply with part 121 when 

it acted as a certifying authority. 40 CFR 

121.13 (2020). 

EPA is finalizing minor, conforming 

modifications to § 121.13(a) and (b) of 

the 2020 Rule. Specifically, consistent 

with the language in section 401(a)(1), 

the Agency is reaffirming that EPA is 

required to provide certification or 

waiver where no state, Tribe, or 

interstate agency has the authority to 

provide certification. 40 CFR 121.16(a). 

The Agency is also reaffirming that, 

when it acts as a certifying authority, 

EPA must comply with both section 401 

and the requirements in part 121. See 40 

CFR 121.16(b). 

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. In the first scenario, 

if a Tribe does not obtain TAS for 

section 401, EPA acts as the certifying 

authority for any federally licensed or 

permitted activity that may result in any 

discharge that originates in Indian 

country lands. As discussed in section 

IV.L in this preamble, a Tribe may 

obtain TAS for section 401 for the 

purpose of issuing water quality 

certifications. 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/oita21-000-6427.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. 

In the second scenario, EPA acts as 

the certifying authority in situations 

where any discharge from any activity 

subject to section 401 certification 

originates where the Federal 

Government has exclusive jurisdiction 

in relevant respects. Some commenters 

said they had concerns with EPA acting 

as the certifying authority for all 

national parks. One commenter more 

broadly argued that section 401 does not 

authorize EPA to issue certifications for 

lands subject to exclusive Federal 


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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. 

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. Yosemite Park 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 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. 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.’’). 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. 

Under this final rule, consistent with 

the 2020 Rule, when EPA acts as the 

certifying authority, it is subject to the 

same requirements as other certifying 

authorities (e.g., reasonable period of 

time to act on a request for certification) 

under section 401 and 40 CFR part 121. 

In contrast to the 2020 Rule, this final 

rule does not retain the request for 

additional information provisions 

included in § 121.14 of the 2020 Rule 

when EPA is the certifying authority. 

EPA proposed to remove § 121.14 of the 

2020 Rule which introduced limits on 

EPA’s ability, as a certifying authority, 

to request additional information from a 

project proponent once the reasonable 

period of time began. See 87 FR 35359 

(June 9, 2022). These provisions 

included a requirement that EPA must 

initially request additional information 

within 30 days of receiving a request for 

certification and limitations on the type 

and scope of additional information 

EPA may request. 40 CFR 121.14(a) 

through (c) (2020). Additionally, the 

2020 Rule required EPA to provide the 

project proponent with a deadline to 

respond to requests for additional 

information and acknowledged that a 

project proponent’s failure to provide 

additional information would neither 

extend the reasonable period of time, 

nor prevent EPA from acting on the 

request for certification. Id. at 

§ 121.14(d) and (e). 

Consistent with the proposal, EPA is 

removing § 121.14 of the 2020 Rule in 

its entirety because it finds these 

provisions not conducive to an efficient 

certification process for several reasons. 

The preamble to the 2020 Rule stated 

that it was ‘‘reasonable to assume that 

Congress intended some appropriate 

limits be placed on the timing and 

nature of such requests [for additional 

information]’’ because of the 

overarching statutory timeline. 85 FR 

42271 (July 13, 2020). Yet, neither the 

2020 Rule preamble nor its regulatory 

text articulated how a 30-day limitation 

on EPA’s initial request for additional 

information is compelled or even 

consistent with the statutory limitation 

that a certifying authority must act 

within a reasonable period of time. 

Although it is ideal for EPA to have 

relevant information to inform its 

analysis early in the reasonable period 

of time, various questions or needs may 

arise later in the review process that are 

critical to EPA acting on a request for 

certification. There is nothing in the 

statutory language that compels or even 

suggests that EPA should have a limited 

ability to use the reasonable period of 

time to request additional information 

to evaluate a request for certification 

and make a fully informed decision. If 

the Agency is limited in its ability to 

request additional information to inform 

its decision, it may need to deny a 

request for certification instead of 

utilizing the additional information to 

possibly grant certification. Such an 

outcome would unnecessarily impede 

the Federal license or permitting 

process. 

The 2020 Rule also unnecessarily 

injected ambiguity into the certification 

process. Section 121.14(b) of the 2020 

Rule limited requests for additional 

information to that which is ‘‘directly 

related to the discharge,’’ while 

§ 121.14(c) of the 2020 Rule limited 

requests only to information than can be 

‘‘collected or generated within the 

reasonable period of time.’’ Yet neither 

the phrase ‘‘directly related to the 

discharge’’ nor ‘‘collected or generated 

within the reasonable period of time’’ 

was defined nor explained in the 

preamble or regulatory text to the 2020 

Rule which introduced uncertainty into 

what kind of information EPA could 

actually request. For example, how 

would the Agency determine if the 

information was directly related to the 

discharge or that the information could 


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be collected or generated within the 

reasonable period of time? Furthermore, 

the statutory language and this final rule 

already place a number of limitations on 

all certifying authority decisions. As 

finalized in § 121.7(b), all certifying 

authorities, including EPA, must act 

within the reasonable period of time 

and within the scope of certification. 

EPA finds that these regulatory 

requirements are sufficient to ensure the 

Agency will act on requests for 

certification in a timely and appropriate 

manner. Consistent with the Agency’s 

removal of the limitations on EPA’s 

ability to request additional 

information, EPA is also finalizing the 

removal of the provisions at § 121.14(d) 

and (e) of the 2020 Rule, which 

discussed how EPA and project 

proponents must respond to requests for 

additional information or lack thereof. 

Consistent with the proposal, § 121.17 

provides that when EPA acts as the 

certifying authority, it ‘‘shall provide 

public notice of the request for 

certification.’’ 40 CFR 121.17(a). The 

Agency revised proposed § 121.17 to 

clarify that EPA will provide public 

notice on the request for certification 

itself, as opposed to merely providing 

public notice on the receipt of the 

request for certification. As proposed, 

this final rule does not limit or specify 

the particular manner(s) in which the 

public notice will occur to support 

broader public participation. The 

Agency is also finalizing as proposed 

that if a public hearing is determined 

appropriate when EPA acts as the 

certifying authority, the hearing should 

be scheduled ‘‘at an appropriate time 

and place and, to the extent practicable, 

give all interested and potentially 

affected parties the opportunity to 

present evidence or testimony in person 

or by other means.’’ 40 CFR 121.17(b). 

The statutory language of section 

401(a)(1) requires states and interstate 

agencies to establish procedures for 

public notice and hearings. The 1971 

Rule stated that EPA could provide 

public notice either by mailing notice to 

state and local authorities, state agencies 

responsible for water quality 

improvement, and ‘‘other parties known 

to be interested in the matter’’ 

(including adjacent property owners 

and conservation organizations), or, if 

mailed notice is deemed 

‘‘impracticable,’’ by publishing notice in 

a newspaper of general circulation in 

the area where the activity is proposed. 

40 CFR 121.23 (2019). With regard to 

hearings, the 1971 Rule provided that 

the Regional Administrator with 

oversight for the area of the proposed 

project has discretion to determine that 

a hearing is ‘‘necessary or appropriate,’’ 

and that ‘‘[a]ll interested and affected 

parties’’ would have reasonable 

opportunity to present evidence and 

testimony at such hearings. Id. EPA 

updated this provision in the 2020 Rule 

to expand the scope of possible parties 

that may receive notice to avoid 

unintentionally narrowing the list of 

potentially interested parties. 85 FR 

42271. Additionally, under the 2020 

Rule, EPA placed a timeframe on when 

the Agency had to provide public notice 

following receipt of a certification 

request and retained discretion to 

provide for a public hearing as 

necessary or appropriate. Id; see 40 CFR 

121.15 (2020). 

EPA is finalizing § 121.17 as 

proposed, with minor, non-substantive 

revisions, to facilitate participation by 

the broadest number of potentially 

interested stakeholders and clarify that 

following such public notice, the 

Administrator shall provide an 

opportunity for public comment. 

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 final rule allows for outreach 

designed to reach all potentially 

interested stakeholders, including 

communities with environmental justice 

concerns. The Agency encourages doing 

so by using all appropriate 

communication and outreach means 

and methods (e.g., through local 

newspapers, online or electronic media, 

or other appropriate media). This 

approach will allow EPA greater 

flexibility to address on a case-by-case 

basis specific issues regarding notice, 

such as broadband access issues and 

requirements for regional publications, 

to provide notice in the most 

appropriate way to allow for broad 

participation. Additionally, EPA is not 

providing an exhaustive list or examples 

of potentially interested parties to avoid 

unintentionally excluding some 

interested stakeholders on that list. EPA 

generally believes those stakeholders to 

whom it is appropriate to provide 

public notice may include state, Tribal, 

county, and municipal authorities, 

heads of state agencies responsible for 

water quality, adjacent property owners, 

and conservation organizations. 

EPA is also finalizing as proposed to 

provide public notice within 20 days 

following the date the request for 

certification is received. The 1971 Rule 

did not set a time frame for EPA’s public 

notice after receiving a request for 

certification. In contrast, the 2020 Rule 

stated that EPA would provide public 

notice 20 days from receipt of a 

certification request. In EPA’s view, 

continuing to provide a timeframe for 

EPA’s issuance of public notice after 

receiving a request for certification will 

contribute to better accountability, 

transparency, and certainty with respect 

to EPA’s handling of requests for 

certification. Generally, EPA finds it 

will be able to provide public notice 

within the final rule’s timeframe. EPA 

finalized an identical timeframe under 

the 2020 Rule, which it has been able 

to meet without difficulty in most 

instances. 

EPA is also finalizing as proposed that 

once the Administrator provides public 

notice on a request for certification, the 

Administrator must provide an 

opportunity for public comment. EPA is 

not defining the length of the public 

comment period. Rather, EPA’s view is 

that the appropriate timeframe for 

comment is more appropriately 

determined on a case-by-case basis, 

considering project-specific 

characteristics. In general, EPA 

anticipates a 30-day comment period; 

however, comment periods as short as 

15 days or as long as 60 days may be 

warranted in some cases, based on the 

nature of the project. 

EPA may also hold a public hearing 

after it provides public notice on a 

request for certification. EPA is 

finalizing the public hearing provision 

at § 121.17(b) as proposed, with minor 

revisions to remove superfluous 

language. For context, the 1971 Rule 

provided that the Regional 

Administrator may hold a public 

hearing at their discretion. 40 CFR 

121.23 (2019). Although ‘‘[a]ll interested 

and affected parties’’ have the 

opportunity to present evidence and 

testimony at a public hearing, the scope 

of the hearing is limited to the question 

of ‘‘whether to grant or deny 

certification.’’ Id. The 2020 Rule carried 

forward the position that the Agency 

has discretion to determine whether a 

public hearing is necessary or 

appropriate; however, the 2020 Rule 

removed the limitation on the subject 

matter of the public hearing. Consistent 

with the 2020 Rule, under § 121.17(b) of 

this final rule, stakeholder input at 

public hearings may cover any relevant 

subject matter on the proposed project 

to best inform EPA as it makes its 

certification decision. 

Commenters generally supported 

EPA’s clarifications around the process 

when it acts as the certifying authority, 

including the public notice and hearing 

provision updates and procedural 

revisions. These commenters said the 

revisions will help EPA act on requests 

in a timely manner. EPA agrees that 

clarifications in the final rule regarding 


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87These include lands within Denali National 

Park, Mount Rainier National Park, Olympic 

National Park, Hot Springs National Park, Hawai’i 

Volcanoes National Park, Yellowstone National 

Park, Yosemite National Park, Sequoia National 

Park, Crater Lake National Park, Glacier National 

Park, Rocky Mountain National Park, Mesa Verde 

National Park, Lassen Volcanic National Park, Great 

Smoky Mountains National Park, Mammoth Cave 

National Park, and Isle Royale National Park. 

88The Agency also finalized and published the 

FY 2022–2026 EPA Strategic Plan in March 2022, 

which includes new environmental justice strategic 

goals and emphasis to be embedded in all EPA 

work. See https://www.epa.gov/planandbudget/ 

strategicplan. 

the process when EPA acts as the 

certifying authority should support 

timely actions and streamline the 

process. EPA finds that the provisions at 

§§ 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. 

b. EPA’s Role as a Technical Advisor 

Section 401(b) provides certifying 

authorities, project proponents, and 

Federal agencies with the ability to ask 

EPA for technical advice on applicable 

effluent limitations, or other limitations, 

standards, regulations, or requirements, 

or water quality criteria, and any 

methods to comply with such 

limitations, standards, regulations, 

requirements, or criteria. See also H.R. 

Rep. No. 92–911, at 124 (1972) (‘‘The 

Administrator may perform services of a 

technical nature, such as furnishing 

information or commenting on methods 

to comply with limitations, standards, 

regulations, requirements, or criteria, 

but only upon the request of a State, 

interstate agency, or Federal agency.’’). 

The 1971 Rule acknowledged this role 

but limited it to provision of technical 

advice on water quality standards. 40 

CFR 121.30 (2019). In the 2020 Rule, the 

Agency modified this provision to 

expand the scope of technical advice 

and assistance EPA might provide to 

better align with the statutory text. 85 

FR 42274–75. 

Consistent with the scope of section 

401(b), EPA is finalizing the proposed 

revisions to the regulatory text at 

§ 121.18 to reflect the statutory text 

more directly. Under this final rule, EPA 

shall provide technical advice, upon 

request 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 authorities, 

and project proponents may request 

EPA’s technical assistance at any point 

in the certification process. 

3. Implementation 

The Agency has made revisions 

throughout this final rule to clarify and 

help in the implementation of EPA’s 

roles under section 401. With respect to 

EPA’s technical advisor role, EPA does 

not intend this final rule to give EPA the 

authority to make certification decisions 

for states and authorized Tribes, or to 

independently review state or Tribal 

certifications or certification requests. 

See H.R. Rep. 92–911, at 124 (1972) 

(‘‘The Committee notes that a similar 

provision in the 1970 Act has been 

interpreted to provide authority to the 

Administrator to independently review 

all State certifications. This was not the 

Committee’s intent. The Administrator 

may perform services of a technical 

nature, such as furnishing information 

or commenting on methods to comply 

with limitations, standards, regulations, 

requirements or criteria, but only upon 

request of a State, interstate agency or 

Federal agency.’’). Nor does the Agency 

consider its role under section 401(b) to 

include providing monetary or financial 

support to certifying authorities in 

implementing their section 401 

programs. The Agency observes that 

there are other means for certifying 

authorities to seek financial assistance 

for their water quality certification 

programs (e.g., CWA section 106 grants). 

Regarding 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. While 

supporting the approach of not 

providing an exclusive list, the 

commenter 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. 

While 16 U.S.C. Chapter 1 identifies 

multiple national parks as having lands 

of exclusive Federal jurisdiction,87 EPA 

does not maintain a map or list 

delineating all lands of exclusive 

Federal jurisdiction. In the preamble to 

the 2020 Rule, EPA noted that the 

number and extent of lands under 

exclusive Federal jurisdiction are 

subject to change and stated that it is the 

obligation of the project proponent to 

determine the identity of the 

appropriate certifying authority when 

seeking section 401 certification. 85 FR 

42270. EPA is maintaining this position 

in the final rule. 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. 

The Agency is also providing further 

insight on its plans to incorporate 

environmental justice into its role as a 

certifying authority. As discussed in 

section III in this preamble, the Agency 

intends for this final rule to address 

essential water quality protection 

policies identified in Executive Order 

13990, including environmental justice. 

In addition to the policy directive from 

Executive Order 13990, other executive 

orders emphasize the importance of 

advancing environmental justice in 

Federal agency actions. See E.O. 12898, 

59 FR 7629 (February 11, 1994) 

(directing agencies to make 

environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority and 

low-income populations in the United 

States), E.O. 14008, 85 FR 7619 (January 

27, 2021) (expanding on the policy 

objectives established in E.O. 12898 and 

directing Federal agencies to develop 

programs, policies, and activities to 

address the disproportionately high and 

adverse human health environmental, 

climate-related and other cumulative 

impacts on vulnerable, historically 

marginalized, and overburdened 

communities, as well as the 

accompanying economic challenges of 

such impacts); E.O. 14096, 88 FR 25251 

(Apr. 21, 2023) (expanding on the policy 

objectives of E.O. 12898 and E.O. 14008 

by further embedding environmental 

justice for all through a whole-ofgovernment approach to environmental 

justice and directing Federal agencies to 

consider measures to address and 

prevent disproportionate and adverse 

environmental and health impacts on 

communities, to actively facilitate 

meaningful public participation and just 

treatment for all people in agency 

decision-making, to identify and 

address gaps in science, data, and 

research related to environmental 

justice, and to increase accountability 

and transparency in Federal 

environmental justice policy).88

Consistent with these directives and 

EPA technical guidance, when EPA acts 

as a certifying authority, the Agency 

should consider impacts on 

communities with environmental justice 

concerns who disproportionately bear 

the burdens of environmental pollution 


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89See 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). 

and hazards, including Tribal Nations. 

In considering impacts from a federally 

licensed 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 decisionmaking on requests for certification. 

Specifically, the Agency intends to 

consider the extent to which the 

‘‘activity’’ or any discharge associated 

with the activity may cause water 

quality-related effects with the potential 

to impact communities with 

environmental justice concerns. 

Additionally, as discussed above, the 

Agency finds that broadening the public 

notice provision will provide 

communities seeking to advance 

environmental justice with greater 

opportunities to inform the certification 

process. 

I. Modifications 

1. What is the Agency finalizing? 

The Agency is finalizing the proposed 

modification provision at § 121.10 with 

revisions to further clarify the process 

based on public comments. Consistent 

with the proposed approach, EPA is 

finalizing a modification provision that 

only concerns modifications to a grant 

of certification (with or without 

conditions) and does not apply to a 

denial of certification or a waiver of 

certification. The Agency has revised 

the regulatory text of the proposed rule 

to explicitly provide in the final rule 

that the certifying authority is not 

required to obtain the Federal agency’s 

agreement on the actual language of the 

modification after reaching an 

agreement to modify the certification. 

Based on commenter feedback and 

recommendations, 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. 

2. Summary of Final Rule Rationale and 

Public Comment 

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). 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. 

To introduce more clarity and balance 

the appropriate amount of flexibility 

and certainty for all stakeholders, EPA 

proposed that a certifying authority may 

modify a previously granted 

certification (with or without 

conditions) after reaching an agreement 

to do so with the Federal licensing or 

permitting agency. This final rule is 

consistent with the Agency’s proposed 

intent, with minor changes to the 

regulatory text to better support 

implementation. Specifically, the final 

rule provides additional clarity 

regarding the agreement between the 

Federal agency and the certifying 

authority. The Agency also removed 

proposed references to revoking or 

modifying a denial or waiver of 

certification and clarified the title of the 

provision to explicitly reflect the final 

provision’s focus on modifications to 

grants of certification. 

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. 

This final rule remains consistent 

with the proposal and the position in 

the 2020 Rule that CWA section 401 

does not provide the authority for 

unilateral modifications to a 

certification decision—either by the 

certifying authority or by the Federal 

licensing or permitting agency—after 

the statutory reasonable period of time 

in which a certifying authority has to act 

on a request for certification. To be 

clear, the Agency does not intend for 

modifications to be used to avoid or 

extend the reasonable period of time 

because § 121.10 in the final rule only 

applies to previously granted 

certifications. 

a. Returning to a Modification Process 

CWA section 401 does not expressly 

authorize or prohibit modifications of 

certifications. Some commenters 

recommended that the final rule not 

include a provision for certification 

modifications 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. EPA disagrees and 

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).89

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) and (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 


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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. 

EPA requested comment on whether 

it should place a time limit on when a 

certifying authority can modify its grant 

of certification in relation to the 

issuance of the Federal license or 

permit. While a few commenters argued 

that a certification should not be 

modified after the Federal license or 

permit is issued, several commenters 

asserted that certification modifications 

may be necessary to account for 

unforeseen water quality impacts during 

the life of the Federal license or permit, 

particularly for projects that can last 

decades. To balance stakeholder 

interests, EPA is not imposing such a 

time limit on when modifications to a 

grant of certification can occur in 

relation to the issuance of the Federal 

license or permit. The final rule’s 

modification provision 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. 

EPA also requested comment on 

whether EPA should identify a list of 

scenarios that may warrant certification 

modification. The preamble to the 

proposed rule provided examples of 

minor changes that may not rise to the 

level of requiring a new request for 

certification, but may be significant 

enough to warrant a modification of the 

granted 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). 87 FR 35361 

(June 9, 2022). However, EPA did not 

propose an exclusive list of scenarios 

that may warrant modification. EPA 

received a wide range of comments on 

whether to list such scenarios, with 

most commenters requesting flexibility 

to address new information or project 

changes without providing specific 

details about what they meant by ‘‘new 

information’’ or ‘‘project changes.’’ A 

couple of commenters recommended 

that EPA develop a list of scenarios 

where modifications are appropriate, 

whereas a few commenters expressed 

support for the modification process 

precisely because the proposal did not 

define all circumstances in which 

modification is appropriate. 

After reviewing public comment, EPA 

is not finalizing such a list 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. 

In contrast to identifying scenarios 

warranting certification modifications, a 

few commenters recommended that 

EPA develop guidance regarding 

scenarios where a new request for 

certification is necessary, instead of a 

certification modification, to provide 

clarity on the outer limits of 

modifications. As noted above, 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 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 after 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.’’). 

b. Limits to Modification of Certification 

Decisions 

In § 121.10 of the final rule, EPA is 

finalizing limits to certification 

modifications. The Agency made small 

changes to the proposed regulatory text 

to clarify these limits, including an 

adjustment of the provision title from 

‘‘Modifications’’ to ‘‘Modification to a 

grant of certification’’ to clarify that 

modifications are limited to grants of 

certification. 40 CFR 121.10. Another 

adjustment was to flip the substance of 

proposed § 121.10(a) and (b) in the final 

rule so that the text first identifies the 

modification process and then its 

limitations. Furthermore, the Agency 

removed references to modifying 

denials or waivers of certification from 

proposed § 121.10(a) and revised the 

term ‘‘modify’’ in proposed 

§ 121.10(a)(4) to ‘‘change’’ in 

§ 121.10(b)(2) of the final rule. 

As noted above, 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. In addition, 

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. 

While the final rule text does not 

address modifications to denials or 

waivers for the reasons discussed above, 


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90Of course, nothing in section 401 or this final 

rule would preclude a project proponent from 

requesting certification again after a denial without 

prejudice and then the certifying authority could 

act in a different manner upon the second request 

if circumstances have changed. See section IV.F in 

this preamble. 

91This statement and more broadly § 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. 

EPA nonetheless concludes for the 

reasons mentioned above 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. As 

discussed in the proposed rule 

preamble, if a certifying authority has 

previously waived certification, that 

waiver may not be modified because 

there would be no ‘‘certification’’ to 

modify. 87 FR 35361–62. Thus, a 

certifying authority may not ‘‘modify’’ a 

waiver by changing it into a grant, a 

grant with conditions, or a denial. And 

finally, a denial of certification cannot 

be modified into a grant (with or 

without conditions) of certification or a 

waiver of certification.90

In contrast to this position, 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 or regulations. One 

commenter suggested that EPA change 

the modification 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. 

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. As discussed 

above, 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.91 EPA reiterates 

that if the activity changes significantly 

after a certification decision has been 

issued (e.g., material change in the 

breadth or location of the activity), this 

may warrant a new request for 

certification. 

i. Timing of Modifications to a Grant of 

Certification 

Under this final rule, a certification 

modification could occur only if the 

certifying authority had granted 

certification (with or without 

conditions) within the reasonable 

period of time. The Agency maintains 

this position from the proposal in the 

final rule because the reasonable period 

of time limitation in the statute 

concerns the certifying authority’s 

action on a request for certification. 

Accordingly, the Agency is finalizing a 

modification provision where a 

modification to an element or a portion 

of a granted certification occurs after the 

reasonable period of time in which the 

certifying authority acted. See 87 FR 

35361 (‘‘Under this proposed 

rulemaking, a certification modification 

could occur after the reasonable period 

of time in which the original 

certification decision was made.’’). 

EPA requested comment on whether 

the certification modification process 

should account for (1) whether there is 

a Federal license or permit modification 

process already in place and (2) the 

point in time at which a modification 

may be made (e.g., if new information 

supporting a modification arises either 

before or after issuance of the license or 

permit). The Agency is not including a 

time limit on when modifications can 

occur so that modifications can happen 

at any time after the reasonable period 

of time ends, including prior to and 

after the issuance of a Federal license or 

permit until the expiration of the license 

or permit. 

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. 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. 

Conversely, 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 

Federal license or permit is issued. 

After considering public comment, 

the Agency is promulgating a final rule 

at § 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 with 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. 

ii. Agreement for a Modification to a 

Grant of Certification 

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 

without conditions) provided that the 

Federal agency and certifying authority 

agree in writing that the certifying 

authority may modify the certification. 

However, such agreement does not 

require the certifying authority and 

Federal agency to agree to the substance 

of such a modification. Although EPA 

recommends that the modification 

process be collaborative, EPA is not 


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92See section IV.H in this preamble discussing 

EPA’s specific roles identified in section 401, 

including acting as a certifying authority on behalf 

of jurisdictions lacking authority, notifying other 

jurisdictions where their water may be affected by 

a discharge from another jurisdiction, and 

providing technical assistance upon request. 

suggesting that Federal agencies and 

certifying authorities must collaborate 

on the specific language of the 

certification modification, as discussed 

more below. Additionally, the certifying 

authority may modify only those 

portions of the certification that the two 

parties agreed upon. 

Similar to the 1971 Rule, EPA is 

finalizing that a modification may only 

occur where a Federal agency and 

certifying authority agree in writing that 

the certification may be modified. While 

the parties must agree that one or 

another part of the certification can be 

modified, the certifying authority is not 

required to obtain the Federal agency’s 

agreement on the specific language of 

such modification. Simply put, EPA 

expects that the certifying authority and 

the Federal agency’s agreement would 

identify those portions of the 

certification decision that the certifying 

authority could modify, and then the 

certifying authority would be 

responsible for drafting the modification 

language. 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 

§ 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. 

Some of the commenters who 

supported the proposed process for 

Federal agency and certifying authority 

agreement to a modification 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 does not review 

certification content during the original 

certification issuance. 

EPA agrees with these commenters. 

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. 

Accordingly, EPA is finalizing a process 

where 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. 

Additionally, EPA requested 

comment on whether the final rule 

should provide project proponents with 

an explicit role in the modification 

process. A few commenters 

recommended that the project 

proponent should have a role in the 

process, for various reasons: because 

section 401 is framed around the role of 

the applicant, because the Federal 

agency and certifying authority may 

lack the technical knowledge for the 

modification; because often the project 

proponent is the party initiating the 

project modification; and because 

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. 

Consistent with the 1971 Rule, 

§ 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 § 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. 

Unlike the 1971 Rule, the Agency is 

not finalizing a role for EPA in the 

certification modification process where 

the Agency is neither the certifying 

authority nor the Federal licensing or 

permitting 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 401.92 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. 

The cooperative approach in the final 

rule does not allow for unilateral 

modifications by certifying authorities, 

which includes through any ‘‘reopener’’ 

clauses included in a grant of 

certification. Reopener clauses purport 

to authorize a certifying authority to 

‘‘reopen’’ and modify a certification at a 

later date. The final rule’s position on 

unilateral modification is consistent 

with the position taken in the 2020 

Rule. See 85 FR 42279. The Agency 

continues to disagree 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. 

Some commenters recommended that 

EPA allow reopener clauses and 

discussed their prevalence in 

certifications. For example, one 

commenter asserted that certifications 

often include ‘‘reopener’’ or 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 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. Another 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 failing to 

meet water quality standards. 

Other commenters recommended that 

the final rule 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 


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93This statement is not meant to address a 

certifying authority’s action on a state or triballyissued license or permit, which sometimes 

concurrently acts as the state or Tribe’s section 401 

certification decision. Such matters are outside the 

scope of this rulemaking. 

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’’ 

are contrary to the express and 

prescriptive provisions for postcertification authority that Congress 

provided in CWA section 401(a)(3) and 

401(a)(4). 

As discussed above, EPA’s final rule 

does not authorize certifying authorities 

to unilaterally (i.e., without Federal 

agency agreement) ‘‘reopen’’ or modify 

a certification decision. This holds true 

regardless of whether a certifying 

authority has inserted language into its 

grant of certification asserting this extra 

power.93 EPA is the Federal agency 

tasked with administering and 

interpreting 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. Certifying 

authorities cannot bootstrap themselves 

greater authority to modify a 

certification beyond what is authorized 

in this final rule at § 121.10. However, 

EPA wishes to emphasize the 

distinction between reopener clauses 

and adaptive management conditions, 

the latter of which are permissible 

under the final rule. See section IV.F of 

this preamble for further discussion of 

adaptive management conditions. 

c. Changes to the NPDES Regulations for 

Certification Modifications 

EPA is also finalizing deletion of 40 

CFR 124.55(b), which described the 

circumstances under which a 

modification may be made to a 

certification on an EPA-issued NPDES 

permit. The approach to modifications 

in § 124.55(b) differed from the 

approach EPA is finalizing at § 121.10. 

First, it addressed a subset of situations 

in which a modification would be 

permissible (i.e., a change in state law 

or a stay, vacatur, or remand of a 

certification), while staying silent 

regarding whether modifications would 

be appropriate in other situations. 

Second, it suggested that in the 

identified situations, such as a change 

in state law or regulation, a previously 

issued grant of certification could be 

converted to a waiver, while this final 

rule takes the general position that a 

certifying authority cannot change a 

grant of certification into a 

fundamentally different certification 

action through a modification pursuant 

to § 121.10. Third, it did not require 

EPA as the Federal permitting agency to 

agree to the modification. Forth, it 

arguably suggested that in the identified 

situations, a modification was more 

appropriate than a new request for 

certification, an issue that EPA 

intentionally does not address in this 

final rule. Finally, it expressly 

precluded EPA from incorporating 

modified conditions into the NPDES 

permit except in one narrow 

circumstance: to delete a NPDES permit 

condition based on a condition in a 

certification invalidated by a state court 

or board, and only upon the request of 

the permittee. However, as discussed 

supra at section IV.G of this preamble, 

section 401(d) requires a Federal 

permitting agency to incorporate 

certification conditions into the Federal 

permit as conditions of that permit. EPA 

sees no reason why this fundamental 

principal should not apply to conditions 

of a modified certification. For this 

reason, EPA expects Federal agencies 

will agree to allow a modification only 

when the agency is willing to modify its 

license or permit or otherwise 

incorporate the modified certification 

conditions into its license or permit. 

EPA is finalizing deletion of § 124.55(b) 

because of these differences in approach 

between this final rule and § 124.55(b). 

As a result of the deletion of § 124.55(b), 

all certification modifications, including 

those for EPA-issued NPDES permits, 

must follow the approach finalized at 

§ 121.10. A corresponding technical edit 

was made to 40 CFR 122.62(a)(3)(iii) to 

remove the reference to § 124.55(b). 

EPA requested comment on whether 

the final rule should allow a certifying 

authority to unilaterally modify a 

certification in the circumstances 

identified in former § 124.55(b) such as 

a change in state law or regulation upon 

which a certification is based, or if a 

court of competent jurisdiction or 

appropriate state board or agency stays, 

remands, or vacates a certification after 

Federal license or permit issuance. A 

few commenters recommended 

retaining 40 CFR 124.55(b) instead of 

the proposed § 121.10. To support their 

recommendation to retain 40 CFR 

124.55(b), one commenter stated that 

EPA failed to describe any confusion, 

regulatory uncertainty, or other 

problems attributed to the certification 

modification provisions in the NPDES 

program. 

In response to these commenters, 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 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 

§ 121.10 to apply to all certification 

modifications, including those on 

certifications for EPA-issued NPDES 

permits. Finally, EPA was concerned 

that leaving § 124.55(b) in place could 

introduce stakeholder confusion when 

read with final rule § 121.10 because it 

may have wrongly indicated that the 

circumstances in § 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 above, § 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 § 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. 

EPA does not expect to develop an 

exhaustive list of circumstances under 

which EPA (when acting as the Federal 

permitting agency) expects to agree to a 

modification to a grant of certification 

by a certifying authority; however, EPA 

will work with certifying authorities 

where unanticipated water quality 

impacts, shifting project design plans, 

and new information warrant a 

modification to a grant of certification 

(and subsequently a modification to an 

EPA-issued NPDES permit). The Agency 

may develop guidance in the future 

regarding Agency agreements to 

modifications of grants of certification 

for NPDES permits issued by EPA. 

3. Implementation 

As previously discussed, the Agency 

is finalizing a process for modifying a 

grant of certification that requires the 

certifying authority and Federal agency 


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94See discussion in section IV.F.2.d of this 

preamble regarding EPA’s recommendation that 

certifying authorities include in their certification 

conditions a statement explaining why each of the 

included conditions is necessary to assure that the 

activity will comply with water quality 

requirements. See also 40 CFR 121.7(d)(3). 

95EPA is finalizing regulatory text regarding 

Federal agency review of certification decisions. 

See section IV.G of this preamble for further 

discussion. 

to agree that a modification is 

appropriate but does not require 

agreement on the substance of the 

modification. The process is meant to 

support a cooperative approach to 

adapting to changing circumstances or 

new information in an efficient and 

transparent way. As with other parts of 

the final rule, EPA is updating the 

section 401 regulations regarding 

modifications to support some of the 

past practices that certifying authorities 

and Federal agencies became familiar 

with over 50 years prior to the 2020 

Rule. This includes a collaborative 

modification process like the one in the 

1971 Rule. EPA is not aware of issues 

with modifications pursued under the 

1971 Rule and notes that many 

stakeholders requested implementation 

guidance after the 2020 Rule omitted a 

process for modifying certification 

decisions. Therefore, 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. 

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. 

The provision at 40 CFR 121.10 also 

does not preclude Federal agencies from 

developing a process for coordinating 

on certification modifications within the 

framework provided in this final rule. 

EPA recommends that certifying 

authorities maintain clear records 

surrounding the development of 

certification decisions and any 

modifications to previously granted 

certifications, including justifications 

for modifying any certification 

conditions.94 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). 

J. Enforcement and Inspections 

1. What is the Agency finalizing? 

This section of the preamble discusses 

several issues that have arisen with 

respect to enforcement of the 

requirement to obtain CWA section 401 

certifications and enforcement of 

certification conditions. EPA did not 

propose to retain any regulatory text 

regarding enforcement of the 

requirement to obtain section 401 

certification or enforcement of 

certification conditions.95 However, 

EPA requested comment on whether it 

should add regulatory text on its 

interpretations on the enforceability of 

certification conditions by Federal 

agencies and certifying authorities; the 

judicial holdings regarding the 

application of the CWA citizen suit 

provision to certifications and 

certification conditions; and the 

interpretation of the term ‘‘review’’ in 

CWA section 401(a)(4). EPA is not 

finalizing any regulatory text on 

enforcement, consistent with the 

proposal. See 87 FR 35363 (June 9, 

2022). Nevertheless, in light of the preproposal input and public comments 

EPA received on this issue, as well as 

stakeholder concern and confusion over 

how the 2020 Rule addressed CWA 

section 401 enforcement, EPA will 

discuss some of the more common 

concerns that have been identified 

regarding enforcement of the 

requirement to obtain section 401 

certification and enforcement of 

certification conditions. To be clear, 

EPA is not offering new interpretations 

or positions on the issues discussed 

below. 

2. Summary of Final Rule Rationale and 

Public Comment 

a. General Enforcement Issues 

Section 401 contains three provisions 

directly relevant to enforcement. First, 

section 401(a)(4) provides certifying 

authorities with an opportunity, prior to 

operation, to inspect a certified federally 

licensed or permitted activity or facility 

that does not require a Federal operating 

license to assure its operation will not 

violate water quality requirement. 33 

U.S.C. 1341(a)(4). If the certifying 

authority determines that the operation 

will violate applicable water quality 

requirements, the Federal agency may 

suspend the Federal license or permit 

after a public hearing. Id. Second, 

section 401(a)(5) provides that any 

certified Federal license or permit may 

be ‘‘suspended or revoked’’ by the 

Federal agency ‘‘upon the entering of a 

judgment under [the CWA] that such 

facility or activity has been operated in 

violation’’ of the enumerated sections of 

the CWA. Id. at 1341(a)(5). Third, 

section 401(d) provides that if a grant of 

certification includes conditions, those 

conditions ‘‘shall become a condition on 

any Federal license or permit subject to 

the provisions of this section.’’ Id. at 

1341(d). 

Of these three provisions, the 1971 

Rule only included regulatory text on 

section 401(a)(4), as discussed below in 

the section on inspection authority. The 

1971 Rule did not contain any 

regulatory provisions addressing section 

401(a)(5) or section 401(d) (the latter of 

which was not added to the statute until 

the 1972 amendments). The 2020 Rule 

addressed section 401(d) and section 

401(a)(4). Regarding section 401(d), the 

2020 Rule stated that the Federal agency 

‘‘shall be responsible for enforcing 

certification conditions’’ incorporated 

into its license or permit. 40 CFR 

121.11(c) (2020). Regarding section 

401(a)(4), the 2020 Rule allowed the 

pre-operation inspection under section 

401(a)(4) of all certified projects, 

regardless of whether they had received 

a subsequent Federal operating license 

or permit. Id. at § 121.11(a) and (b) 

(2020). The 2020 Rule preamble also 

stated that the ‘‘CWA does not provide 

an independent regulatory enforcement 

role for certifying authorities,’’ 85 FR 

42275 (July 13, 2020), and declined to 

finalize an interpretation regarding 

CWA section 505 citizen suits and 

section 401. Id. at 42277. 

In both pre-proposal input and public 

comment, stakeholders generally agreed 

that Federal agencies could enforce 

certification conditions. However, 

stakeholders expressed concern that the 

2020 Rule prevented states and Tribes 

from exercising their independent 

enforcement authority and relied solely 

on Federal agencies to enforce 

certification conditions. Many 

commenters raised concerns over 

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 state and Tribal 

enforcement, otherwise the conditions 

may never be enforced. Conversely, 

some commenters asserted that 

certifying authorities did not have an 

enforcement role either under section 

401 or any other provision of the CWA, 


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including section 505 (the CWA’s 

citizen suit provision). Other 

commenters asserted that section 505 

provided for citizen suit enforcement of 

both failures to obtain section 401 

certification and failure to comply with 

certification conditions. Many 

commenters requested that EPA 

expressly state in the final rule that 

states and Tribes have independent 

authority under the CWA to enforce 

certifications and certification 

conditions. 

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. 

The Agency views section 401 

certification conditions that are 

incorporated into the Federal license or 

permit as enforceable by Federal 

licensing or permitting agencies. 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, see 

supra). 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, as noted above, the 2020 

Rule included regulatory text that 

explicitly stated that Federal agencies 

were responsible for enforcing 

certification conditions incorporated 

into its Federal license or permit. 40 

CFR 121.11(c) (2020). EPA proposed to 

remove this regulatory provision 

because it 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. Most commenters 

supported EPA’s proposal to remove the 

2020 Rule’s language at § 121.11(c). 

However, some commenters disagreed 

with EPA’s proposed approach, arguing 

that the enforcement of certification 

conditions incorporated into Federal 

licenses or permits must lie exclusively 

with the Federal permitting and 

licensing agencies. EPA disagrees. 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 ‘‘[n]othing 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, see supra) (‘‘Many 

states and tribes assert they may enforce 

401 certification conditions using their 

water quality standards authority.’’). 

Some commenters argued that Federal 

and certifying authority enforcement 

will lead to confusion, unnecessary 

litigation, and possibly duplicative or 

inconsistent enforcement actions and 

conditions. 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. 

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. 

b. Certifying Authority Inspection 

Authority 

As discussed above, section 401(a)(4) 

identifies one set of circumstances 

where the certifying authority may 

review the manner in which a facility or 

activity will operate once the facility or 

activity has received certification. 33 

U.S.C. 1341(a)(4). The certifying 

authority’s review is limited to 

determining if the post-construction 

operation of the facility or activity will 

ensure that applicable effluent 

limitations, other limitations, or other 

applicable water quality requirements 

will not be violated. Section 401(a)(4) 

further states that when the certifying 

authority notifies the Federal agency 

that the operation or activity will violate 

effluent limits, other limits or other 

water quality requirements, the Federal 

agency, after public hearing, may 

suspend the Federal license or permit. 


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96See section IV.C.2 of the preamble regarding 

the expectation that the Federal license or permit 

application be complete. See section IV.K.2 of this 

preamble infra for further discussion about the 

contents of the Federal agency’s notification to EPA. 

97See section IV.K.2.d. of this preamble infra for 

further discussion of the requirement for the 

neighboring jurisdictions process to conclude 

before issuance of a license or permit by a Federal 

agency. 

Id. The Federal license or permit shall 

remain suspended until there is 

reasonable assurance that the facility or 

activity will not violate CWA section 

301, 302, 303, 306, or 307. Id. 

The 1971 Rule clarified that the 

ability to ‘‘review the manner in which 

the facility or activity shall be operated 

or conducted’’ meant the right to inspect 

a facility or activity, and that the 

inspection is limited to a situation 

where there was a Federal construction 

license or permit and a subsequent 

Federal operating license or permit was 

not required. The 1971 Rule set forth the 

procedure regarding inspection and 

subsequent inspection findings; 

however, these regulations only applied 

where EPA was the certifying authority. 

See 40 CFR 121.26 through 121.28 

(2019). The 2020 Rule interpreted 

section 401(a)(4) to apply to all 

certifying authorities. It also expanded 

the ability to conduct inspections 

pursuant to section 401(a)(4) to any 

certified project where the Federal 

license or permit and certification were 

issued prior to operation, instead of 

only for projects where there was a 

Federal construction license or permit 

and a subsequent Federal operating 

license or permit was not required. 40 

CFR 121.11(a) (2020); 85 FR 42277. In 

pre-proposal input, several stakeholders 

pressed the Agency to allow for 

inspections before, during, and postoperation. 

EPA is removing § 121.11(a) and (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. A few commenters 

recommended that the Agency add 

regulatory text regarding section 

401(a)(4). However, 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. EPA interprets the term 

‘‘review’’ found in section 401(a)(4) as 

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. EPA 

requested comment on whether it 

should articulate this interpretation of 

section 401(a)(4) in regulatory text. A 

few commenters recommended that 

EPA adopt regulatory text regarding its 

proposed interpretation of the term 

‘‘review’’ found in section 401(a)(4). 

After considering public comments, 

however, EPA finds it unnecessary to 

add regulatory text defining the term 

‘‘review’’ as used in section 401(a)(4). 

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. 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. 

K. Neighboring Jurisdictions 

1. What is the Agency finalizing? 

The Agency is finalizing its proposed 

approach to the section 401(a)(2) 

process, referred to as the neighboring 

jurisdictions process, with some 

modifications to the regulatory text for 

clarity. See 40 CFR part 121, subpart B. 

The Agency is adding text to § 121.12 

of the final rule, which provides the 

contents of a notification to the Regional 

Administrator, to clarify that Federal 

licensing and permitting agencies notify 

EPA upon receipt of a Federal license or 

permit application 96 and certification or 

waiver by providing written notification 

to the ‘‘appropriate’’ Regional 

Administrator. EPA is also modifying 

the proposed text of § 121.13, which 

provided that a Federal license or 

permit ‘‘may not be issued pending the 

conclusion of the process described’’ in 

§§ 121.14 and 121.15, to more clearly 

state that a Federal license or permit 

‘‘shall not be issued pending the 

conclusion of the process described’’ in 

§ 121.13 (EPA’s determination of effects 

on neighboring jurisdictions) as well as 

§§ 121.14 and 121.15.97

For purposes of language consistency 

and clarity, the Agency removed 

‘‘certified or waived’’ from the proposed 

language of § 121.13(a), which stated 

that ‘‘[w]ithin 30 days after the Regional 

Administrator receives notice in 

accordance with § 121.12(a), the 

Regional Administrator shall determine 

whether a discharge from the certified 

or waived project may affect water 

quality in a neighboring jurisdiction.’’ 

The removal of ‘‘certified or waived’’ is 

intended to remove redundancy, as 

§ 121.12(a) already states that the 

Federal agency shall provide written 

notification to the appropriate Regional 

Administrator ‘‘[w]ithin five days of the 

date that it has received both the 

application and either a certification or 

waiver for a Federal license or permit,’’ 

and to ensure conformity of the use of 

‘‘discharge from the project’’ across 

subpart B. 

Additionally, EPA is finalizing most 

of § 121.13(c), which provides the 

contents of the Regional Administrator’s 

may affect notification, as proposed, 

except the Agency is revising the 

proposed language in § 121.13(c)(3) to 

conform the statement that the Agency 

provides to notified neighboring 

jurisdictions more closely with the 

statutory text of section 401(a)(2) and 

provide greater clarity about notification 

needed for an objection. Rather than 

providing a statement that the notified 

neighboring jurisdiction ‘‘has 60 days’’ 

to provide written notification ‘‘whether 

it has determined that the discharge will 

violate any of its water quality 

requirements,’’ as proposed in 

§ 121.13(c)(3), the final rule states that 

the Agency provides a statement that 

the notified neighboring jurisdiction 

‘‘has 60 days after such notification’’ 

from the Agency to provide written 

notification ‘‘if it has determined that 

the discharge will violate any of its 

water quality requirements.’’ 40 CFR 

121.13(c)(3). This revision more closely 

reflects the statutory text of section 

401(a)(2) which provides that a notified 

neighboring jurisdiction may object to 

issuance of a Federal license or permit 

‘‘[i]f, within sixty days after receipt’’ of 

notification from the Agency it 

‘‘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). As a result, the text 

of § 121.13(c)(3) of the final rule also 

more clearly conveys the statutory time 


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and content requirements of the 

notification needed for an objection 

than the proposed regulatory text. 

EPA is also modifying the proposed 

text of §§ 121.13 and 121.14 to remove 

language requiring the Administrator 

and notified neighboring jurisdiction to 

provide notification to the certifying 

authority during the neighboring 

jurisdictions process, to more closely 

reflect the statutory language in section 

401(a)(2), which does not require such 

notification to the certifying authority in 

this process. 

Further, the Agency is modifying the 

proposed text of §§ 121.14 and 121.15 to 

clarify that references to a ‘‘neighboring 

jurisdiction’’ in these provisions refer to 

a ‘‘notified’’ neighboring jurisdiction, 

meaning a neighboring jurisdiction that 

has received notification that the 

Regional Administrator has determined 

that a discharge from the project may 

affect the neighboring jurisdiction’s 

water quality. The proposed text of 

§ 121.14(a) referenced notice being 

provided to a neighboring jurisdiction 

‘‘in accordance with § 121.13(c),’’ and 

the language in §§ 121.14 and 121.15 

referred to ‘‘the neighboring 

jurisdiction’’ or ‘‘a neighboring 

jurisdiction’’ without more explicitly 

stating that the provisions were 

addressing ‘‘notified’’ neighboring 

jurisdictions. In the final rule, EPA is 

revising the internal citation in 

§ 121.14(a) to more appropriately 

reference § 121.13(b), the provision in 

the final rule requiring the Regional 

Administrator to provide notification 

upon determining that discharge from 

the project may affect water quality in 

a neighboring jurisdiction. Likewise, 

EPA is revising the ‘‘neighboring 

jurisdiction’’ references in §§ 121.14 and 

121.15 to specify that these refer to a 

‘‘notified’’ neighboring jurisdiction, to 

remove ambiguity and improve clarity 

in these sections. 

The Agency is also adding language to 

the provision in § 121.15 to clarify the 

process for the Federal agency to 

provide notice of a hearing on a section 

401(a)(2) objection, and provide greater 

transparency as to how Federal agencies 

provide such notification. The proposed 

text of § 121.15(b) required the Federal 

agency conducting a hearing on an 

objection from a neighboring 

jurisdiction to ‘‘provide public notice at 

least 30 days in advance of the hearing.’’ 

In the final rule, § 121.15(b) requires the 

Federal agency in such circumstances to 

‘‘provide public notice at least 30 days 

in advance of the hearing to interested 

parties, including but not limited to the 

neighboring jurisdiction, the certifying 

authority, the project proponent, and 

the Regional Administrator.’’ This 

addition clarifies that that such notice 

must go to interested parties to ensure 

that they can prepare for and provide 

their testimony or comments at the 

public hearing. It further provides a 

greater level of transparency regarding 

how all Federal licensing or permitting 

agencies will provide public notice of a 

hearing on an objection. 

Additionally, for purposes of 

improving the efficiency and clarity of 

the neighboring jurisdictions process in 

circumstances where a notified 

neighboring jurisdiction seeks to 

withdraw a previously issued objection, 

EPA is adding text in §§ 121.14 and 

121.15 of the final rule to allow for 

withdrawal of an objection in these 

circumstances. Specifically, § 121.14(c) 

of the final rule provides that ‘‘[t]he 

notified neighboring jurisdiction may 

withdraw its objection prior to the 

public hearing. If the notified 

neighboring jurisdiction withdraws its 

objection, it shall notify the Regional 

Administrator and the Federal agency, 

in writing, of such withdrawal.’’ 

Consistently, EPA is adding text to 

§ 121.15(a) of the final rule, providing 

that the Federal licensing or permitting 

agency shall hold a public hearing on 

the notified neighboring jurisdiction’s 

objection ‘‘unless the objection is 

withdrawn in accordance with 

§ 121.14(c).’’ As discussed further 

below, EPA finds 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, and conserves resources that 

would otherwise be expended to 

conduct and participate in such a 

hearing in these circumstances. 

Additionally, the added text regarding 

withdrawal of an objection in §§ 121.14 

and 121.15 of the final rule add clarity 

by establishing a uniform procedure for 

executing withdrawal of an objection. 

As discussed in greater detail below, 

EPA is finalizing its proposed approach 

to the definition of neighboring 

jurisdiction, the scope of the 

neighboring jurisdictions process, the 

circumstances initiating the neighboring 

jurisdictions process, and the timing in 

which a Federal licensing or permitting 

agency must provide notification to EPA 

pursuant to section 401(a)(2). The 

Agency is also maintaining its 

previously stated positions regarding 

the roles of the Federal licensing or 

permitting agency, EPA, and a 

neighboring jurisdiction in the 

neighboring jurisdictions process, but is 

providing some further discussion 

regarding certain aspects of these roles 

below to provide added clarity. 

2. Summary of Final Rule Rationale and 

Public Comment 

a. Definition of Neighboring Jurisdiction 

The Agency is finalizing the 

definition of neighboring jurisdiction at 

§ 121.1(g) as proposed. This final rule 

revises the definition of this term used 

in the 2020 Rule to clarify that it 

includes ‘‘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), other than the 

jurisdiction in which the discharge 

originates or will originate.’’ See 40 CFR 

121.1(g). In contrast, 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. 40 

CFR 121.1(i) (2020). As EPA noted in 

the proposed rule, 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 current definition also reflects 

the TAS provisions for Indian Tribes to 

administer section 401 that are being 

finalized in § 121.11. 

A few commenters addressing the 

definition of neighboring jurisdiction in 

the proposed rule advocated for EPA to 

adopt a narrower definition of this term. 

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). 


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b. Scope of the Neighboring 

Jurisdictions Process 

The Agency is also maintaining in the 

final rule the interpretation of the scope 

of section 401(a)(2) stated in the 

proposed rule. In the proposed rule, 

EPA interpreted the scope of section 

401(a)(2) as limited by the statutory 

language to considering potential effects 

only from a ‘‘discharge’’ from an 

activity, explaining that this is based 

upon the statutory language in section 

401(a)(2) which limits EPA to 

considering whether a ‘‘discharge’’ from 

an activity may affect the water quality 

of a neighboring jurisdiction, and 

likewise limits a neighboring 

jurisdiction to determining whether a 

‘‘discharge’’ from the activity will affect 

its water quality so as to violate any 

water quality requirements. 87 FR 35365 

(June 9, 2022). A few commenters 

observed that EPA’s proposed 

interpretation of the scope of section 

401(a)(2) differed from its proposed 

interpretation of the scope for 

certification, and one such commenter 

asserted that EPA’s differing 

interpretations of scope for certification 

and the neighboring jurisdictions 

process in section 401(a)(2) is arbitrary. 

EPA disagrees. 

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. One commenter asserted 

that the scope of section 401(a)(2), 

outlining the neighboring jurisdictions 

process, is the same as section 401(a)(1), 

relating to certification, because section 

401(a)(2) is inextricably linked to 

section 401(a)(1) through the use of 

‘‘such’’ referring to the scope of 

discharges addressed in section 

401(a)(1). 

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 

above, the scope 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. The 

text of the neighboring jurisdictions 

process in the Water Quality 

Improvement Act of 1970 (in section 

21(b)(2)) used ‘‘such a discharge’’ and 

‘‘such discharge’’ language later 

employed in section 401(a)(2), even 

though the 1970 act used the term 

‘‘activity’’ in place of ‘‘discharge’’ in 

what is now section 401(a)(1). The 

‘‘discharge’’ language for the 

neighboring jurisdictions process 

remained unchanged during the 1972 

amendments that changed the language 

regarding certification 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. A more limited scope of 

review is consistent with the more 

limited nature of the neighboring 

jurisdictions process. 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 


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98See 33 U.S.C. 1341(a)(2) (‘‘Upon receipt of such 

application and certification the licensing or 

permitting agency shall immediately notify the 

Administrator of such application and 

certification.’’) (emphasis added). 

99 In fact, the language in section 401(a)(1) 

describes waivers of certification as a substitute for 

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 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. 

c. Circumstances Initiating the 

Neighboring Jurisdictions Process 

The Agency is finalizing its proposed 

approach to clarify that both grants of 

certification (with or without 

conditions) and waivers of certification 

initiate the neighboring jurisdictions 

process established by section 401(a)(2). 

Section 401(a)(2) provides that the 

Federal licensing or permitting agency 

must immediately notify the EPA 

Administrator upon receipt of a Federal 

license or permit application and 

certification. 33 U.S.C. 1341(a)(2). 

Under the 1971 Rule, EPA’s section 

401(a)(2) review was initiated upon 

receipt of either a certification or a 

waiver, which was treated as a 

substitute for certification. See 40 CFR 

121.11, 121.16 (2019). In the 2020 Rule, 

EPA’s section 401(a)(2) review was 

initiated only upon receipt of a 

certification. 40 CFR 121.12(a) (2020); 

see 85 FR 42287 (July 13, 2020). 

Additionally, the 2020 Rule further 

provided that a Federal agency may 

issue a license or permit upon issuance 

of a written notice of waiver. 40 CFR 

121.9(e) (2020). As proposed, EPA is 

returning to the approach taken in the 

1971 Rule that the neighboring 

jurisdictions process is initiated by 

either a certification or waiver. 

Although the statutory text does not 

explicitly identify waiver of certification 

as an action that initiates the 

neighboring jurisdictions process in 

section 401(a)(2),98 the Agency 

maintains that it is reasonable to 

interpret the waiver of certification as a 

substitute for a grant of certification for 

purposes of section 401(a)(2) review for 

several reasons. First, this treatment is 

consistent with the purpose of section 

401(a)(2). Section 401(a)(2) provides a 

mechanism for a notified neighboring 

jurisdiction to object to the issuance of 

a Federal license or permit when it 

determines that discharge from a project 

originating in another jurisdiction will 

affect the quality of its waters thus 

violating its water quality requirements. 

A waiver does not indicate a certifying 

authority’s substantive opinion 

regarding the water quality implications 

(for itself or another jurisdiction) of a 

project subject to Federal licensing or 

permitting. Rather, a certifying authority 

may affirmatively waive certification for 

a variety of reasons, including a lack of 

resources to evaluate the project. In 

addition, a certifying authority may be 

deemed to have waived certification if 

that certifying authority fails or refuses 

to act on a request for certification 

before the end of the reasonable period 

of time. See section IV.F of this 

preamble for further discussion on 

waivers of certification. Ultimately a 

waiver of certification allows the 

Federal licensing or permitting agency 

to issue its license or permit without 

receipt of a water quality certification. 

As a result, a waived certification could 

result in water quality impacts that 

might violate a neighboring 

jurisdiction’s water quality 

requirements. It is reasonable to afford 

a mechanism for EPA and a neighboring 

jurisdiction to evaluate that possibility. 

Second, the approach taken under the 

2020 Rule to exclude waivers from the 

neighboring jurisdictions process 

created a method for certifying 

authorities to circumvent the 

neighboring jurisdictions process in 

circumstances where they are aware of 

water quality concerns from a 

neighboring jurisdiction regarding a 

project. As noted above, EPA finds that 

section 401(a)(2) was established as a 

mechanism to allow 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. EPA does not find that 

the statutory language of section 

401(a)(2) supports such circumvention 

of the neighboring jurisdictions process, 

as this would thwart the very purpose 

of the process established by the 

statutory text. 

Finally, including waivers as actions 

initiating the neighboring jurisdictions 

process was the Agency’s position for 

over 50 years prior to the 2020 Rule. See 

40 CFR 121.16 (2019). The final rule 

provides clarification on when waiver of 

certification has occurred, allowing 

Federal agencies to provide EPA notice 

of the Federal license or permit 

application and waiver as required by 

§ 121.12 of the final rule. Therefore, 

consistent with the approach taken in 

the 1971 Rule, the Agency is restoring 

the interpretation that waivers, in 

addition to certifications, initiate the 

neighboring jurisdictions process 

established in section 401(a)(2). 

Accordingly, in § 121.12(a) of the final 

rule, the Agency is clarifying that the 

neighboring jurisdictions process is 

initiated when the Federal agency ‘‘has 

received both the application and either 

a certification or waiver for a Federal 

license or permit,’’ and must provide 

notice to EPA. Additionally, as 

proposed, the Agency is removing the 

regulatory provision located at 

§ 121.9(e) of the 2020 Rule, which 

provided that a Federal agency may 

issue a license or permit upon issuance 

of a written notice of waiver. As 

discussed above, under this final rule 

waivers of certification also initiate the 

neighboring jurisdictions process and 

EPA may make a ‘‘may affect’’ 

determination based upon a waiver of 

certification. See 40 CFR 121.12(a). 

Consistent with the language at 

§ 121.13(d) of the final rule, a Federal 

agency shall not issue a Federal license 

or permit pending the conclusion of the 

neighboring jurisdictions process. 

Several commenters provided input 

on the proposed approach to have 

waiver initiate the neighboring 

jurisdictions process. A few commenters 

agreed that a waiver should initiate the 

neighboring jurisdictions process and 

asserted that this approach would 

improve the neighboring jurisdictions 

process. Conversely, a few other 

commenters argued that a waiver should 

not initiate the neighboring jurisdictions 

process and asserted that that there is no 

statutory basis for the inclusion of 

waivers in this process. One of these 

commenters added that expanding the 

notification process beyond what the 

statute provides would lead to needless 

process and delays. 

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 above, 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.99


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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 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. 

100Several commenters suggested that the 

neighboring jurisdictions process resulted, in part, 

from the 1971 Rule. As discussed, the statutory text 

of section 401(a)(2) establishes this process. 

Employing a more restrictive 

interpretation would 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. 

d. Neighboring Jurisdictions Process 

Must Conclude Before Federal License 

or Permit Issuance 

The proposed text of § 121.13(d) 

included language intended to explain 

that the neighboring jurisdictions 

process must conclude before a Federal 

agency issues a license or permit, stating 

that ‘‘[a] Federal license or permit may 

not be issued pending the conclusion of 

the process described in §§ 121.14 and 

121.15.’’ This proposed text retained 

language similar to § 121.12(c) of the 

2020 Rule, which stated that ‘‘[t]he 

federal license or permit may not be 

issued pending the conclusion of the 

processes.’’ 40 CFR 121.12(c) (2020). 

The Agency is modifying the proposed 

text of § 121.13 to more clearly state that 

a Federal agency is prohibited from 

issuing a license or permit subject to 

section 401 certification pending 

conclusion of the neighboring 

jurisdictions processes addressed in 

§§ 121.13, 121.14, and 121.15. 

Specifically, EPA changed the proposed 

text of § 121.13(d) from providing that 

the Federal license or permit ‘‘may not 

be’’ issued pending the conclusion of 

the neighboring jurisdictions process to 

more directly stating that the Federal 

license or permit ‘‘shall not be’’ issued 

pending the conclusion of the 

neighboring jurisdictions process. 

Further, EPA modified the text of 

§ 121.13 to make clear that the 

neighboring jurisdictions process 

includes the processes described in 

§§ 121.13, 121.14, and 121.15. These 

changes are consistent with the 

proposed regulatory text, but provide 

further clarity that pursuant to § 121.13, 

and the statutory text of section 

401(a)(2), a Federal agency cannot 

proceed with issuing its license or 

permit until the neighboring 

jurisdictions process set forth in 

§§ 121.13, 121.14, and 121.15 has 

concluded. 

In practical terms, this means that 

Federal agencies must wait to issue a 

Federal license or permit until the 

neighboring jurisdictions process has 

concluded. The neighboring 

jurisdictions process may conclude in 

several different ways, depending on 

factual and procedural circumstances. 

One way the neighboring jurisdictions 

process concludes occurs when the 

appropriate Regional Administrator has 

completed the ‘‘may affect’’ 

determination within 30 days after 

receiving notice from the Federal 

agency, pursuant to § 121.13(a), without 

making a ‘‘may affect’’ finding. In such 

circumstances, the neighboring 

jurisdictions process has concluded, 

and the Federal agency may proceed 

with issuing the Federal license or 

permit without waiting for further 

proceedings. 

In contrast, when the appropriate 

Regional Administrator completes the 

‘‘may affect’’ determination by making a 

‘‘may affect’’ finding and provides 

notification of this finding pursuant to 

§ 121.13(b), the Federal agency must 

wait to issue the Federal license or 

permit until the notified neighboring 

jurisdiction has made a ‘‘will violate’’ 

determination, pursuant to § 121.14, 

within 60 days of the notification from 

EPA pursuant to § 121.13, or this time 

period has passed. Where a notified 

neighboring jurisdiction has determined 

that a discharge will violate its water 

quality requirements and has provided 

notification of its objection and request 

for hearing pursuant to § 121.14(a) and 

(b), the Federal agency cannot issue the 

license or permit until either the public 

hearing process described in § 121.15 is 

completed, or the notified neighboring 

jurisdiction withdraws its objection 

pursuant to § 121.14(c). 

A few commenters raised concerns 

regarding the neighboring jurisdictions 

process delaying the issuance of Federal 

licenses or permits. Additionally, a 

commenter asserted that EPA should 

consider only requiring the neighboring 

jurisdictions process for larger, complex 

individual permit projects because of 

wide-ranging implications of this 

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.100 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 further below, 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. EPA also 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. 

e. Federal Licensing or Permitting 

Agency’s Role in Initiating the 

Neighboring Jurisdictions Process 

Section 401(a)(2) requires the Federal 

licensing or permitting agency to notify 

EPA immediately upon receipt of a 

Federal license or permit application 

and the related section 401 water 

quality certification. 33 U.S.C. 

1341(a)(2). This notification from the 

Federal agency commences the 

remaining steps of the neighboring 

jurisdictions process addressed in 

section 401(a)(2) and discussed in 

§§ 121.13, 121.14, and 121.15 of the 

final rule. The 1971 Rule established 

some procedural requirements for this 

notification process, which EPA 

updated in the 2020 Rule. The 2020 

Rule included additional specificity on 

the timing of Federal agency notification 

but did not contain a standardized 

process for notification. 40 CFR 

121.12(a) (2020). Instead, under the 

2020 Rule, EPA relied on Federal 

agencies to develop notification 

processes and procedures that work 

within their licensing or permitting 

programs. 85 FR 42273. 

In the proposed rule, the Agency 

likewise proposed regulatory text to 


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101Although this statutory language is 

unambiguous, EPA is further discussing when 

receipt occurs due to questions and conflicting 

practices among Federal licensing and permitting 

agencies. For example, some Federal agencies 

provide notice to EPA concurrently with its public 

notice on the licensed or permitted application, see, 

e.g., 33 CFR 325.2(b)(1)(i) (‘‘The public notice for 

such activity . . . will serve as the notification to 

the Administrator . . . pursuant to section 401(a)(2) 

of the Clean Water Act.’’). Such practices are not 

consistent with the statutory language or this final 

rule. It is necessary that certification or waiver 

occur for EPA to make a determination as to 

whether a discharge from the activity ‘‘may affect’’ 

the water quality of a neighboring jurisdiction 

under section 401(a)(2), as EPA only makes such a 

determination where certification or waiver has 

occurred, and considers any conditions included in 

a certification in making this determination. 

provide clarity regarding the timing by 

which a Federal agency must provide 

notification to EPA pursuant to section 

401(a)(2), and further proposed 

additional procedures for Federal 

agencies to follow when providing 

notification to EPA. In the final rule, 

EPA is maintaining its interpretation of 

the timing for Federal agencies to 

provide notification pursuant to the 

statutory text in section 401(a)(2), and 

otherwise finalizing the proposed 

procedures for Federal agencies to 

follow when providing notification to 

EPA with some minor changes to the 

text of § 121.12 and the deletion of the 

definition of ‘‘application’’ proposed at 

§ 121.1(c). 

i. Timing of Notice From a Federal 

Agency 

As noted, to initiate the neighboring 

jurisdictions process, a Federal 

licensing or permitting agency must 

‘‘immediately’’ notify EPA when it 

receives a Federal license or permit 

application and a section 401 

certification. 33 U.S.C. 1341(a)(2). EPA 

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. This approach 

retains the same interpretation of 

‘‘immediately’’ used in the 2020 Rule. 

40 CFR 121.12(a) (2020); see 85 FR 

42273. 

EPA is also finalizing the regulatory 

text in § 121.12(a) of the final rule 

providing that ‘‘[w]ithin five days of the 

date that it has received both the 

application and either a certification or 

waiver for a Federal license or permit, 

the Federal agency shall provide written 

notification to the appropriate Regional 

Administrator.’’ EPA is finalizing this 

provision with only minor changes from 

the proposal for added clarity. 

Specifically, EPA added language to 

specify that the Federal agency shall 

provide the written notification to the 

‘‘appropriate’’ Regional Administrator, 

but otherwise maintained the proposed 

text providing that the period for the 

Federal agency to provide such 

notification commences upon ‘‘the date 

that it has received both the application 

and either a certification or waiver.’’ See 

87 FR 35380. 

As previously discussed, this 

provision reflects EPA’s interpretation 

that the neighboring jurisdictions 

process set forth in section 401(a)(2) is 

initiated by either certification or 

waiver. See supra for further discussion 

on actions initiating the neighboring 

jurisdictions process. It further makes 

clear that the Federal agency is only 

considered to be in receipt of an 

application for a Federal license or 

permit and certification within the 

meaning of section 401(a)(2) when such 

agency has received both an application 

for a Federal license or a permit, as 

discussed above, and has either 

received a corresponding certification or 

a waiver has occurred.101

EPA received several comments on its 

proposal to retain the five-day 

interpretation of ‘‘immediately’’ in the 

context of section 401(a)(2). A few 

commenters agreed with EPA 

maintaining the five-day interpretation 

of immediately, asserting that this 

period was adequate for such notice and 

consistent with the statutory language. 

However, one commenter argued that 

providing Federal agencies with five 

calendar days to notify EPA is an 

unrealistic timeframe, and asked EPA to 

consider interpreting ‘‘immediately’’ as 

five business days or ten calendar days. 

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. 

Several commenters discussed the 

proposed language, finalized in 

§ 121.12(a) of the final rule, which 

establishes that a Federal agency’s 

obligation to provide notification to EPA 

only commences upon the Federal 

agency’s receipt of both the Federal 

license or permit application and either 

certification or waiver. One commenter 

agreed with this approach, noting that 

the Agency’s clarification on this point 

will ensure that EPA and neighboring 

jurisdictions have necessary information 

to make determinations within the 

neighboring jurisdictions process, and 

that this otherwise addresses confusion 

and information gaps caused by prior 

inconsistent information sharing 

practices. A few commenters, however, 

suggested that the Federal agency 

should be able to provide notification to 

EPA prior to receipt of certification, 

such as upon a receipt of an application 

for a Federal license or permit and a 

request for certification. One such 

commenter argued that requiring the 

Federal agency to be in receipt of both 

the Federal license or permit 

application and certification before 

notifying EPA would increase delays in 

the Federal licensing or permitting 

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). 

A few commenters argued that 

requiring Federal agencies to provide 

notification to EPA after receipt of a 

certification precluded Federal agencies 

from providing notification to EPA 

earlier (e.g., after receipt of an 

application for a Federal license or 

permit), therefore prohibiting Federal 

agencies from engaging in early 

coordination with EPA. However, this is 

not correct. Nothing in the proposed 

text, or final rule, prevents a Federal 

agency from providing notification to 

EPA of a Federal license or permit 


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102For this final rulemaking, EPA is not 

suggesting that Corps civil works projects are 

exempt from neighboring jurisdictions processes, 

even though there are no ‘‘applications’’ or draft 

Federal licenses or permits. Rather, EPA expects the 

Corps to determine how best to comply with all 

section 401 requirements. Compliance may involve 

the Corps sending a project study in conjunction 

with a certification or a waiver of certification. 

103As previously discussed, EPA interprets the 

waiver of certification as a substitute for a grant of 

certification for purposes of section 401(a)(2). See 

section IV.K.2.c. of this preamble for further 

discussion of this interpretation. 

application for purposes of early 

coordination. Rather, such notice for 

coordination purposes does not satisfy 

the requirement that the Federal agency 

provide notification to EPA upon 

receipt of the Federal license or permit 

application and certification or waiver, 

pursuant to § 121.12 of the final rule, 

and would not commence the 30-day 

period for EPA’s ‘‘may affect’’ 

determination pursuant to section 

401(a)(2). Thus, EPA is providing this 

clarification in the final rule. 

With regard to the meaning of 

‘‘application’’ for purposes of section 

401(a)(2), the Agency is maintaining the 

position stated in the proposed rule that 

within this context the term 

‘‘application’’ is used to refer to the 

‘‘application for such Federal license or 

permit.’’ See 87 FR 35366. Section 401 

uses the term ‘‘application’’ throughout 

section 401(a); however, when read in 

context, the term is used for both 

‘‘applications for certification’’ and 

‘‘applications for such Federal license or 

permit.’’ 33 U.S.C. 1341(a)(1)–(2). The 

Agency considers the ‘‘request for 

certification’’ to be an ‘‘application for 

certification.’’ See section IV.C in this 

preamble for further discussion on 

request for certification. The context of 

the relevant statutory language in 

section 401(a)(2), directing the Federal 

agency to provide notification to EPA 

‘‘[u]pon receipt of such application and 

certification,’’ reflects that this use of 

the term ‘‘application’’ refers to 

‘‘application for such Federal license or 

permit,’’ rather than ‘‘application for 

certification.’’ Id. at 1341(a)(2). 

Accordingly, the obligation for the 

Federal agency to provide notification to 

EPA pursuant to section 401(a)(2) is 

initiated upon receipt of both a Federal 

license or permit application and either 

a section 401 certification or a waiver of 

certification. 

In the proposed rule, EPA noted that 

there are instances where a Federal 

license or permit application does not 

accompany a certification or waiver, 

and therefore proposed to define the 

term ‘‘application’’ to mean ‘‘an 

application for a license or permit 

submitted to a Federal agency, or if 

available, the draft license or permit’’ to 

account for differing Federal licensing 

or permitting practices. EPA received a 

few comments related to this definition 

in the context of the Federal agency 

providing notification to EPA pursuant 

to section 401(a)(2). One commenter 

argued that EPA should not require the 

Federal agency to have a draft Federal 

license or permit when it notifies EPA 

under the neighboring jurisdictions 

process. In contrast, another commenter 

supported draft Federal licenses or 

permits being included in notification to 

EPA where such drafts are provided 

before a certification decision. However, 

as previously discussed, in the context 

of requests for certification, many 

commenters opposed to EPA’s proposed 

approach of requiring the project 

proponent to include the draft Federal 

license or permit in all requests for 

certification. As a result, EPA is 

finalizing a bifurcated approach. A 

project proponent seeking certification 

on the issuance of a general license or 

permit must submit a copy of the draft 

Federal license or permit in its request 

for certification. A project proponent 

seeking certification on an individual 

license or permit must submit a copy of 

the Federal license or permit 

application in its request for 

certification. See section IV.C in this 

preamble for discussion on bifurcated 

request for certification process; 40 CFR 

121.5(a). As a result of the comments 

received related to the proposed 

definition of ‘‘application’’ and finalized 

approach regarding use of draft Federal 

licenses or permits in the request for 

certification context, EPA is not 

finalizing the proposed definition of the 

term ‘‘application’’ in the proposed rule. 

Although the Agency is not proposing a 

definition of the term ‘‘application’’ in 

the final rule, it 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).102

ii. Contents of Notification From a 

Federal Agency 

Although the text of section 401(a)(2) 

requires a Federal agency to notify EPA 

upon receipt of a Federal license or 

permit application and certification,103

it does not define the contents of such 

notification. 33 U.S.C. 1341(a)(2). The 

1971 Rule and 2020 Rule provided some 

direction on information that could be 

submitted to EPA as part of the 

neighboring jurisdictions process, but 

neither regulation defined the contents 

of the section 401(a)(2) notification. See 

40 CFR 121.12(b) (2020); 40 CFR 121.13 

(2019). 

The 1971 Rule provided that upon 

receipt of an application for a license or 

permit with an accompanying 

certification, the Federal agency shall 

forward copies of the application and 

certification to the Regional 

Administrator. 40 CFR 121.11 (2019). It 

further stated that only those portions of 

the application which relate to water 

quality shall be forwarded to the 

Regional Administrator and allowed for 

the Regional Administrator to ask for 

supplemental information if the 

documents forwarded did not contain 

sufficient information to make the 

determination provided for in § 121.13. 

See 40 CFR 121.12 and 121.13 (2019). In 

the preamble to the 2020 Rule, EPA 

stated its expectation that Federal 

agencies would develop notification 

processes and procedures, but noted 

that the Administrator could request 

copies of the certification and Federal 

license or permit application. 85 FR 

42273. During implementation of the 

2020 Rule, some but not all agencies 

developed their own procedures, and 

such procedures varied between Federal 

agencies and across the country. 

EPA is finalizing its proposed 

approach to add regulatory text defining 

the minimum level of information that 

must be included in the notification to 

EPA to provide consistency in practices 

across Federal agencies and to 

streamline the notification process. In 

§ 121.12(a), the Agency provides that 

the notification must be in writing and 

contain a general description of the 

proposed project, including but not 

limited to the Federal license or permit 

identifier, project location information 

(e.g., latitude and longitude), a project 

summary including the nature of any 

discharge and size or scope of activity, 

and whether the Federal agency is 

aware of any neighboring jurisdiction 

providing comment on the project. If the 

Federal agency is aware that a 

neighboring jurisdiction provided 

comment about the project, the 

notification shall include a copy of 

those comments. 40 CFR 121.12(a)(2). 

Additionally, the notification shall 

include a copy of the certification or 

notice of waiver, and the Federal license 

or permit application. 40 CFR 

121.12(a)(1). 

EPA is also finalizing the proposed 

approach allowing the Regional 

Administrator to submit a written 

request to a Federal agency upon 

determining there is a need for 

supplemental information to make a 

determination about potential 

neighboring jurisdiction effects 

pursuant to section 401(a)(2). 40 CFR 


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104Notably, the court in Fond du Lac did not 

opine on the specific meaning of ‘‘may affect’’ or 

factors that EPA should consider in making a ‘‘may 

affect’’ determination. See 519 F. Supp. 3d 549. 

121.12(b). This provision allows the 

Regional Administrator to request that 

such information be provided in a 

timely manner for EPA’s ‘‘may affect’’ 

determination and provides that the 

Federal agency ‘‘shall obtain that 

information from the project proponent 

and forward the additional information 

to the Administrator within such 

timeframe.’’ Likewise, the Agency is 

finalizing the proposed language 

allowing the Regional Administrator to 

develop agreements with Federal 

agencies to refine the notification 

process and the provision of 

supplemental information, in 

§ 121.12(c) of the final rule. 

One commenter addressing these 

proposed provisions argued 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 requiring 

such information would exceed EPA’s 

authority under section 401(a)(2) and 

could result in 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 such 

information should be limited to 

existing information that is readily 

available. EPA disagrees that the 

provision in § 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 § 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. 

f. EPA’s Role Under Section 401(a)(2) 

Section 401(a)(2) provides that 

whenever a discharge ‘‘may affect, as 

determined by the Administrator, the 

quality of the waters of any other State,’’ 

the Administrator must notify the 

neighboring jurisdiction, Federal 

agency, and the project proponent of the 

determination within thirty days of the 

date of notice of the application. 33 

U.S.C. 1341(a)(2). In § 121.13 of the final 

rule, EPA is finalizing its proposed 

approach to making a ‘‘may affect’’ 

determination and providing 

notification of a determination that a 

discharge from a project may affect the 

water quality of a neighboring 

jurisdiction, although it is doing so with 

changes to the proposed regulatory text 

to omit the requirement that EPA 

provide such notice to a certifying 

authority, and to provide further 

clarification that a Federal license or 

permit cannot be issued without the 

neighboring jurisdictions processes 

concluding, as discussed above. EPA is 

otherwise maintaining its positions 

regarding the requirement that EPA 

make a ‘‘may affect’’ determination, the 

timing of this determination and 

notification, the meaning of ‘‘may 

affect’’ and EPA’s ‘‘may affect’’ analysis, 

and procedural and content 

requirements of ‘‘may affect’’ 

notification, as reflected in § 121.13 of 

the final rule and discussed further 

below. 

i. Requirement for EPA To Make ‘‘May 

Affect’’ Determination 

At proposal, EPA stated its 

interpretation that the statutory text of 

section 401(a)(2) requires the Agency to 

determine whether a discharge ‘‘may 

affect’’ a neighboring jurisdiction once it 

receives notification of the application 

and certification or waiver. 87 FR 

35367. Therefore, EPA proposed 

regulatory text in § 121.13(a) providing 

that the Regional Administrator ‘‘shall 

determine whether a discharge from the 

certified or waived project may affect 

water quality in a neighboring 

jurisdiction.’’ EPA is finalizing the 

proposed language in § 121.13(a) of the 

final rule with revisions to remove the 

term ‘‘certified or waived.’’ The removal 

of ‘‘certified or waived’’ is intended to 

ensure language conformity across 

subpart B, and remove redundancy, as 

§ 121.12(a) of the final rule already 

states that once the Federal agency ‘‘has 

received both the application and either 

a certification or waiver,’’ the Federal 

agency ‘‘shall provide written 

notification to the appropriate Regional 

Administrator.’’ 40 CFR 121.12(a) 

(emphasis added). 

Under the 1971 Rule, the Regional 

Administrator was required to review 

the Federal license or permit 

application, the certification, and any 

supplemental information provided to 

EPA, and, if the Regional Administrator 

determined that there was ‘‘reason to 

believe that a discharge may affect the 

quality of the waters of any State or 

States other than the State in which the 

discharge originates,’’ the Regional 

Administrator would notify the affected 

jurisdictions within thirty days of 

receipt of the Federal license or permit 

application materials and certification. 

See 40 CFR 121.13 (2019). Similarly, the 

2020 Rule acknowledged EPA’s 

responsibility to notify a neighboring 

jurisdiction whenever it determined that 

a discharge from the certified activity 

may affect the water quality of the 

neighboring jurisdiction. 40 CFR 

121.12(b) (2020); 85 FR 42274. However, 

the 2020 Rule asserted that it was 

within the Agency’s discretion whether 

to make a ‘‘may affect’’ determination in 

the first place, and that EPA was, 

therefore, not required to make such a 

determination. 85 FR 42273. 

To date, EPA is only aware that one 

Federal district court has addressed 

EPA’s obligation to make a 

determination pursuant to section 

401(a)(2). In Fond du Lac Band of Lake 

Superior Chippewa v. Wheeler, 519 F. 

Supp. 3d 549 (D. Minn. 2021), the court 

addressed two issues concerning section 

401(a)(2): (1) whether EPA is required to 

make a ‘‘may affect’’ determination and 

(2) whether EPA’s ‘‘may affect’’ 

determination is judicially reviewable. 

The court concluded that EPA is 

required to determine whether the 

discharge may affect the quality of a 

neighboring jurisdiction’s waters 

pursuant to section 401(a)(2). In coming 

to this conclusion, the court examined 

the statutory text and found that it 

requires EPA to make ‘‘a discrete factual 

determination . . . within a specific 

timeframe . . . based on an application 

and certification. . . .’’ Id. at 564. The 

court found that ‘‘the existence of such 

a clear and limited timeframe supports 

the argument that the statute imposes a 

duty on EPA to make a ‘may affect’ 

determination.’’ Id. Further, the court 

concluded that Federal courts have the 

jurisdiction to review EPA’s ‘‘may 

affect’’ determination.104

The Agency agrees with the court in 

Fond du Lac that EPA, pursuant to 

section 401(a)(2), must determine 

whether a discharge ‘‘may affect’’ a 


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neighboring jurisdiction once it receives 

notification of the Federal license or 

permit application and certification or 

waiver from the Federal agency 

consistent with § 121.12(a) of the final 

rule. As discussed by the court in Fond 

du Lac, the statutory language in section 

401(a)(2), which requires the Agency to 

provide notification within a set 

timeframe to a neighboring jurisdiction 

when it finds that discharge from the 

project may affect its water quality, 

supports finding that EPA is required to 

make a ‘‘may affect’’ determination. See 

Fond du Lac, 519 F.Supp.3d at 563–64. 

Accordingly, the Agency is finalizing 

language in § 121.13(a) of the final rule, 

with the modifications discussed above, 

to reflect this interpretation and clarify 

that the Regional Administrator shall 

make this determination, consistent 

with the Agency’s interpretation of 

section 401(a)(2). 

EPA received comments regarding its 

interpretation of section 401(a)(2) 

requiring the Agency to make a ‘‘may 

affect’’ determination, and commenters 

were divided on whether EPA is 

required to make a ‘‘may affect’’ 

determination. Some commenters 

agreed with EPA’s interpretation and 

the language in the proposal stating that 

section 401(a)(2) requires EPA to make 

a ‘‘may affect’’ determination upon 

receiving notice from the Federal 

licensing or permitting agency. Reasons 

cited for supporting this position 

included the rationale provided by the 

court in Fond du Lac, cited by some 

commenters, and the assertion that this 

approach better allows neighboring 

jurisdictions to protect their water 

quality and provides transparency 

regarding the Agency’s actions. 

Some other 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 Federal licenses or permits subject to 

section 401. In addition to asserting the 

position, taken in the 2020 Rule, that 

the statutory language provides EPA 

discretion as to whether to make a ‘‘may 

affect’’ determination, some of these 

commenters otherwise argued that 

requiring EPA to make a ‘‘may affect’’ 

determination for all Federal licenses or 

permits subject to section 401 would be 

an inefficient use of EPA resources and 

would result in unnecessary delays in 

the Federal licensing or permitting 

process. 

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 § 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). 

ii. Timing of EPA’s ‘‘May Affect’’ 

Determination and Notification 

As previously discussed, section 

401(a)(2) requires EPA to provide 

notification ‘‘within thirty days of the 

date of notice of application for such 

Federal license or permit’’ to the 

neighboring jurisdiction, the Federal 

Agency, and the project proponent 

whenever it determines that a discharge 

from a project may affect the water 

quality of a neighboring jurisdiction. 33 

U.S.C. 1341(a)(2). EPA finds that the 

‘‘notice of application for such license 

or permit’’ references the prior statutory 

text of section 401(a)(2) requiring the 

Federal agency to immediately notify 

the Administrator ‘‘[u]pon receipt of 

such application and certification.’’ See 

section IV.K.2.e in this preamble for 

discussion regarding timing of Federal 

agency notification to EPA pursuant to 

section 401(a)(2). Accordingly, EPA 

finds that section 401(a)(2) provides 

EPA with a 30-day period to make its 

‘‘may affect’’ determination and provide 

any required notification after receiving 

notice from the Federal agency of the 

Federal license or permit application 

and certification or waiver. EPA has, 

therefore, incorporated this 30-day 

period into the provisions it is finalizing 

in § 121.13(a) and (b) regarding its ‘‘may 

affect’’ determination and ‘‘may affect’’ 

notification, as it proposed. This is 

consistent with the approach taken in 

the 2020 Rule, which also provided a 

30-day period for the EPA to make a 

‘‘may affect’’ determination and provide 

‘‘may affect’’ notification following 

appropriate notice from the Federal 

agency. See 40 CFR 121.12 (2020). 

A few commenters discussed the 

period EPA is provided to make a ‘‘may 

affect’’ determination or ‘‘may affect’’ 

notification. One commenter argued that 

30 days is too long of a period for EPA 

to make ‘‘may affect’’ determinations, 

and suggested EPA limit the timeframe 

to complete these determinations to 15 

days. Another commenter requested that 

EPA establish a reasonable period of 

time to provide notification to the 

Federal agency and certifying authority 

calculated from the date the individual 

certification is issued for purposes of 

avoiding unnecessary permitting delays. 

As discussed above, 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 timeframe 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 period reflected in statute for 

making a ‘‘may affect’’ determination 

and providing any required notification. 

iii. EPA’s ‘‘May Affect’’ Determination 

and ‘‘May Affect’’ Standard 

Section 401(a)(2) provides that EPA 

makes the ‘‘may affect’’ determination 

in the neighboring jurisdictions process, 

as discussed above, but notably does not 

delineate specific factors for the Agency 

to consider in determining whether a 

discharge from a project may affect the 

water quality of a neighboring 

jurisdiction. See 33 U.S.C. 1341(a)(2). 

Likewise, the 2020 Rule did not address 

in either preamble or regulatory text 

whether there are specific factors that 

the EPA considers in making a ‘‘may 

affect’’ determination or whether any 

other interested party can be involved in 

making this determination. See 85 FR 

42273. During the pre-proposal 

outreach, stakeholders raised concerns 

that EPA had not clearly identified what 

factors it intended to use in determining 

whether a discharge ‘‘may affect’’ the 

water quality of a neighboring 

jurisdiction. Stakeholders also objected 


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105The Agency notes, as it did at proposal, that 

there are other opportunities for stakeholders to 

provide input into the certification and Federal 

licensing or permitting process, including the 

public notice and comment processes on the 

certification and the Federal license or permit. 

to EPA asserting sole discretion over 

this ‘‘may affect’’ determination without 

obtaining input from the neighboring 

jurisdiction or other stakeholders. 

In the preamble to the proposed rule, 

EPA asserted that the Agency, in making 

a ‘‘may affect’’ determination, has 

discretion to look at a variety of factors 

depending on the type of Federal 

license or permit and discharge. 87 FR 

35367. EPA further stated that factors it 

may consider in making a ‘‘may affect’’ 

determination include but are not 

limited to the type of project and 

discharge covered in the Federal license 

or permit, the proximity of the project 

and discharge to other jurisdictions, 

certification conditions and other 

conditions already contained in the 

draft Federal license or permit, and the 

neighboring jurisdiction’s water quality 

requirements. 87 FR 35367–68. The 

Agency clarified that it was not 

proposing to identify 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. The Agency noted 

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. Id. However, the Agency 

solicited comment on whether such a 

list of specific factors that EPA must 

consider in making a ‘‘may affect’’ 

determination should be set forth in 

regulation and, if so, what factors 

should be included. Id. 

Additionally, in the proposal, the 

Agency clarified its position that it has 

sole discretion under section 401(a)(2) 

to examine the facts and determine 

whether the discharge ‘‘may affect’’ the 

quality of a neighboring jurisdiction’s 

waters once it receives notice from a 

Federal agency initiating its obligation 

to make a ‘‘may affect’’ determination. 

87 FR 35368. As a result, EPA stated 

that the Agency is not required to 

engage with stakeholders or seek their 

input in making this determination, and 

otherwise noted interested parties may 

have recourse under the Administrative 

Procedure Act, as discussed in Fond du 

Lac case. Id.; see also Fond du Lac, 519 

F.Supp.3d at 565–67. However, EPA 

stated that it intends to consider the 

views of neighboring jurisdictions in 

making its ‘‘may affect’’ determination if 

such views are provided in a timely 

manner. Id. Specifically, the Agency 

proposed regulatory language in 

§ 121.12(a), as discussed above, to 

define 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.105

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 ‘‘[w]henever 

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, as previously 

discussed, 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 § 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. 

Some commenters disagreed with 

EPA’s position on the role of 

neighboring jurisdictions or other 

stakeholders during in its ‘‘may affect’’ 

process. A few commenters suggested 

that EPA consult with or involve 

neighboring jurisdictions in making 

‘‘may affect’’ determinations. 

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. 

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. 

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 ‘‘[w]henever 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). Some commenters 

sought, or offered, further 

interpretations of the ‘‘may affect’’ 

standard in section 401(a)(2). Such 

commenters asserted differing 

interpretations of the meaning of the 

‘‘may affect’’ standard, including 

recommending that EPA make an actual 

demonstration that there may be an 

effect and suggesting that it is a low 

threshold (i.e., some reasonable 

possibility an effect may exist). As 

stated above, EPA is not defining the 

meaning of the ‘‘may affect’’ standard. 

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 


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106See section IV.E of this preamble for further 

discussion on the breadth of water quality effects 

that may be considered under section 401. 

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.106

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. 

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. 

Accordingly, EPA is identifying that 

such factors include, but are not limited 

to, the type of project and discharge 

covered in the Federal license or permit, 

the proximity of the project and 

discharge to neighboring jurisdictions, 

certification conditions and, as 

applicable, other conditions already 

contained in the draft Federal license or 

permit, 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. Based on public 

comments, EPA is also identifying 

additional factors it may consider. 

Specifically, EPA may consider the 

current water quality and characteristics 

of the water receiving the discharge in 

making a ‘‘may affect’’ determination. 

However, EPA reiterates that it is 

neither limited to considering, nor 

required to consider, the factors 

identified here. 

With regard to the Agency’s proposed 

approach of identifying factors it may 

consider in making a ‘‘may affect’’ 

determination, most commenters 

addressing this approach 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 could 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 

constrained by the statutory bounds of 

section 401. 

However, commenters were notably 

divided on the approach the Agency 

should take to identifying these factors. 

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. 

Commenters supporting this position 

collectively asserted that this approach 

would limit subjectivity in such 

determinations, increase predictability, 

and allow Federal agencies and project 

proponents to better plan for these 

determinations. 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. In 

contrast, some other commenters 

supported EPA’s proposed approach to 

identify examples of factors the Agency 

may consider, but did not recommend 

requiring EPA to consider factors in 

recognition of the fact-dependent nature 

of ‘‘may affect’’ determinations. 

EPA agrees that its discretion 

regarding making a ‘‘may affect’’ 

determination is bounded by the 

statutory grant of authority in section 

401. 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. 

iv. ‘‘May Affect’’ Notification 

If EPA determines that a discharge 

from a project may affect a neighboring 

jurisdiction’s water quality, section 

401(a)(2) requires EPA to notify the 

neighboring jurisdiction, Federal 

agency, and the project proponent. 33 

U.S.C. 1341(a)(2). As previously 

discussed, EPA must provide such 

notification within 30 days from notice 

provided by the Federal agency in 

accordance with section 401(a)(2). See 

id.; section IV.K.2.f.ii in this preamble 

for discussion on timing of EPA’s may 

affect finding and any resulting notice. 

Notably, a finding by EPA that a 

discharge from a project may affect a 

neighboring jurisdiction’s water quality 

pursuant to section 401(a)(2) is often 

referred to as a ‘‘may affect’’ finding, 

and the resulting notification of this 

finding is referred to as a ‘‘may affect’’ 

notification. Section 401(a)(2) does not 

require EPA to provide notification in 

circumstances where it has completed 

its ‘‘may affect’’ determination but has 

not found that a discharge from the 

project may affect a neighboring 

jurisdiction’s water quality (i.e., has not 

made a ‘‘may affect’’ finding). See 33 

U.S.C. 1341(a)(2). Accordingly, in its 

proposal, EPA stated that it is not 

required to provide notification of its 

‘‘may affect’’ determination in such 

circumstances. Consistently, EPA 

further stated that if a Federal agency 

does not receive notification from EPA 

that a discharge may affect a 

neighboring jurisdiction’s water quality 

within 30 days after the proper notice, 

then the Federal agency may proceed 

with processing the Federal license or 

permit. 87 FR 35368. 

EPA received comments relating to its 

‘‘may affect’’ notification in the 

neighboring jurisdictions process. A few 

commenters expressed concern that 

EPA is not required to provide a 

response when not finding that a 


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discharge may affect the water quality of 

a neighboring jurisdiction and suggested 

that lack of a response could have 

meaning other than this finding. Some 

of these commenters proposed that EPA 

provide notification to neighboring 

jurisdictions in circumstances where the 

Agency’s ‘‘may affect’’ determination 

does not result in ‘‘may affect’’ finding, 

or otherwise suggested that the Agency 

provide public notice regarding its ‘‘may 

affect’’ determination. Some 

commenters supporting these 

approaches to notification asserted that 

they would increase transparency 

regarding EPA’s ‘‘may affect’’ 

determination and inform interested 

parties regarding this determination. 

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. 

In addition to incorporating the 

notification requirements on EPA in 

section 401(a)(2) pertaining to a ‘‘may 

affect’’ finding, the 2020 Rule 

established additional procedures for 

EPA in providing such notification. The 

2020 Rule required EPA to provide such 

notification to the certifying authority, 

as well as the neighboring jurisdiction, 

Federal agency, and the project 

proponent. 40 CFR 121.12(c) (2020). 

Additionally, the 2020 Rule required the 

notification to be dated and in writing 

and established certain requirements on 

the content of such notification. 40 CFR 

121.12(c)(1) (2020). Specifically, the 

2020 Rule required that the notification 

identify the materials provided by the 

Federal agency and inform the 

neighboring jurisdiction that it had 60 

days to notify the Administrator and the 

Federal agency, in writing, whether it 

had determined that the discharge will 

violate any of its water quality 

requirements, to object to the issuance 

of the Federal license or permit, and to 

request a public hearing from the 

Federal agency. Id. In contrast, the 1971 

Rule did not define the contents of a 

‘‘may affect’’ notification from EPA to a 

neighboring jurisdiction, Federal 

agency, and project proponent. 

However, the 1971 Rule required EPA to 

send the neighboring jurisdiction a copy 

of the application and certification it 

received to initiate the neighboring 

jurisdictions process. 40 CFR 121.14 

(2019). 

EPA proposed retaining regulatory 

text similar to that in the 2020 Rule 

requiring EPA to provide the ‘‘may 

affect’’ notification to the neighboring 

jurisdiction, Federal agency, the project 

proponent, and the certifying authority. 

The Agency further proposed 

maintaining content requirements for 

the ‘‘may affect’’ notification, but 

proposed revising these requirements to 

establish that the notification shall be in 

writing and shall include a statement 

that the Agency has determined that the 

discharge may affect the neighboring 

jurisdiction’s water quality, as well as a 

description of the next steps in the 

neighboring jurisdictions process, a 

copy of the certification or waiver, and 

a copy of the Federal license or permit 

application. 

In § 121.13(b) and (c) of the final rule, 

EPA is finalizing the proposed approach 

for providing a ‘‘may affect’’ notification 

with minor changes to the content 

requirements for a ‘‘may affect’’ 

notification and the omission of the 

requirement that EPA provide such 

notice to a certifying authority. As noted 

above, EPA revised the proposed text of 

§ 121.13(c), addressing the contents of 

the Regional Administrator’s ‘‘may 

affect’’ notification, to conform the 

statement that the Agency provides to 

notified neighboring jurisdictions more 

closely with the statutory text of section 

401(a)(2) and provide greater clarity 

about notification needed for an 

objection. Rather than providing a 

statement that the notified neighboring 

jurisdiction ‘‘has 60 days’’ to provide 

written notification ‘‘whether it has 

determined that the discharge will 

violate any of its water quality 

requirements,’’ as proposed in 

§ 121.13(c)(3), the final rule states that 

the Agency provides a statement that 

the notified neighboring jurisdiction 

‘‘has 60 days after such notification’’ 

from the Agency to provide written 

notification ‘‘if it has determined that 

the discharge will violate any of its 

water quality requirements.’’ 40 CFR 

121.13(c)(3). This revision ensures that 

the ‘‘may affect’’ notification reflects the 

statutory text of section 401(a)(2) and 

more clearly conveys the statutory time 

and content requirements of the 

notification needed for an objection 

than the proposed regulatory text. 

Likewise, as previously mentioned, 

§ 121.13(b) and (c) of the final rule was 

revised to omit the requirement that 

EPA provide the ‘‘may affect’’ 

notification to the certifying authority. 

Although the 2020 Rule required EPA to 

provide the ‘‘may affect’’ notification to 

the certifying authority, and proposed 

retaining this provision, EPA is omitting 

such notification to the certifying 

authority in the final rule to more 

closely reflect the statutory language in 

section 401(a)(2), which does not 

require such notification to the 

certifying authority. This is consistent 

with the Agency’s approach in the final 

rule to likewise remove language from 

the proposed regulatory text requiring a 

notified neighboring jurisdiction to 

provide notification to the certifying 

authority in § 121.14. Both changes 

reflect the structure of the neighboring 

jurisdictions process established in 

section 401(a)(2), which does not 

provide a specified role for the 

certifying authority. 

In addition to EPA’s role in the 

neighboring jurisdictions process to 

make a ‘‘may affect’’ determination and 

provide ‘‘may affect’’ notification, as 

addressed in § 121.13 of the final rule 

and described above, the Agency also 

has at role at a hearing on an objection 

of a notified neighboring jurisdiction, 

which is reflected in § 121.15(c) of the 

final rule and discussed further below. 

See section IV.K.2.h in this preamble for 

discussion of the Agency’s role to 

provide its evaluation and 

recommendations concerning the 

objection at such hearing and 

§ 121.15(c). 

g. Neighboring Jurisdiction’s Role Under 

Section 401(a)(2) 

CWA section 401(a)(2) provides that 

if, within 60 days after receipt of EPA’s 

‘‘may affect’’ notification, a neighboring 

jurisdiction determines that such 

discharge will affect the quality of its 

waters so as to violate any water quality 


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requirements in its jurisdiction, and 

within such 60-day period notifies the 

Administrator and the Federal licensing 

or permitting agency in writing of its 

objection to the issuance of such Federal 

license or permit and requests a public 

hearing, the Federal licensing or 

permitting agency shall hold a public 

hearing on the objection. 33 U.S.C. 

1341(a)(2). Therefore, only neighboring 

jurisdictions notified by EPA may object 

to issuance of a Federal license or 

permit and request a hearing on this 

objection pursuant to section 401(a)(2). 

Further, in order for a notified 

neighboring jurisdiction to make an 

objection, it must (1) determine that a 

discharge from the project for which it 

received such notification will affect the 

quality of its waters so as to violate any 

of its water quality requirements, and 

(2) provide written notification of its 

objection and request for hearing to EPA 

and the Federal licensing or permitting 

agency within sixty days after receipt of 

notification from EPA. Notably, the 

determination made by a notified 

neighboring jurisdiction as to whether a 

discharge from the project will affect the 

quality of its waters so as to violate any 

water quality requirements is often 

referred to as a ‘‘will violate’’ 

determination. The provisions in the 

final rule regarding a notified 

neighboring jurisdiction’s ‘‘will violate’’ 

determination and notification of 

objection and request for hearing are 

discussed below. 

i. ‘‘Will Violate’’ Determination and 

Standard 

Under section 401(a)(2), a notified 

neighboring jurisdiction’s ‘‘will violate’’ 

determination is based upon whether a 

discharge from the project ‘‘will affect 

the quality of its waters so as to violate 

any water quality requirements’’ in its 

jurisdiction. 33 U.S.C. 1341(a)(2). EPA 

incorporated this standard in the 

proposed text of § 121.14(a), which 

reflected that the neighboring 

jurisdiction ‘‘determines that a 

discharge will violate any of its water 

quality requirements.’’ However, EPA 

did not propose to further define the 

‘‘will violate’’ standard applied by 

notified neighboring jurisdictions, or 

otherwise identify specific factors that 

neighboring jurisdictions may or must 

consider in making this determination. 

EPA is revising the proposed text of 

§ 121.14 to clarify that the ‘‘will violate’’ 

determination is made only by a 

notified neighboring jurisdiction, and is 

therefore adding text to § 121.14(a) 

providing that a ‘‘will violate’’ 

determination is made by ‘‘a 

neighboring jurisdiction notified by the 

Regional Administrator pursuant to 

§ 121.13(b),’’ and is otherwise revising 

references to ‘‘the neighboring 

jurisdiction’’ in the proposed text to 

‘‘the notified neighboring jurisdiction’’ 

in § 121.14 of the final rule. EPA is 

otherwise modifying the text of 

§ 121.14(a) to further reflect that the 

notified neighboring jurisdiction is 

evaluating ‘‘discharge from the project.’’ 

40 CFR 121.14. These changes were 

made to add clarity, as pursuant to 

section 401(a)(2), only notified 

neighboring jurisdictions make a ‘‘will 

violate’’ determination, and this 

determination evaluates discharge from 

the project for which the neighboring 

jurisdiction received such notification 

from EPA. See 33 U.S.C. 1341(a)(2). EPA 

is otherwise maintaining the proposed 

approach in the final rule to not further 

define the ‘‘will violate’’ standard in 

regulation or identify factors for 

consideration in making this 

determination. 

EPA received comment related to the 

‘‘will violate’’ standard applied by 

notified neighboring jurisdictions. One 

commenter requested that EPA modify 

proposed § 121.14 to ensure that the 

regulation reflects that the ‘‘will affect’’ 

standard includes a discharge’s 

contributions to water quality violations 

and that the discharge itself does not 

have to be the sole cause of the water 

quality violation. EPA finds that the 

statutory text of section 401(a)(2), and 

the consistent text of § 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 § 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 § 121.15 of the final rule. 

ii. Notification of Objection and Request 

for Hearing 

As previously noted, section 401(a)(2) 

requires a notified neighboring 

jurisdiction to provide written 

notification of its objection and request 

for hearing to EPA and the Federal 

licensing or permitting agency within 

sixty days after receipt of notification 

from EPA in order to raise an objection. 

See 33 U.S.C. 1341(a)(2). The statutory 

text, however, does not further describe 

the contents of this written notification. 

The 1971 Rule did not describe the 

contents or form that such an objection 

notification must take. However, the 

2020 Rule provided that ‘‘[n]otification 

of objection and request for a hearing 

from the neighboring jurisdiction shall: 

be in writing; identify the receiving 

waters it determined will be affected by 

the discharge; and identify the specific 

water quality requirements it 

determines will be violated by the 

certified project. 40 CFR 121.12(c)(2) 

(2020); 85 FR 42274. 

EPA proposed to revise the specific 

regulatory requirements for what a 

neighboring jurisdiction is required to 

include in an objection notification and 

request for hearing sent pursuant to 

section 401(a)(2) in proposed 

§ 121.14(b). Consistent with the 

statutory text of section 401(a)(2), the 

Agency proposed to retain the 

requirement that the objection be in 

writing. Additionally, EPA proposed 

that the notification of objection and 

request for hearing from the notified 

neighboring jurisdiction include ‘‘[a] 

statement that the neighboring 

jurisdiction objects to the issuance of 

the Federal license or permit’’ (proposed 

§ 121.14(b)(1)), and ‘‘[a] request for a 

public hearing from the Federal agency 

on its objection’’ (proposed 

§ 121.14(b)(3)). However, rather than 

requiring the notified neighboring 

jurisdiction to identify the receiving 

waters affected by the discharge and the 

specific water quality requirements 

violated as required in the 2020 Rule, 

EPA proposed in § 121.14(b)(2) that the 

notification include ‘‘[a]n explanation of 

the reasons supporting the neighboring 

jurisdiction’s determination that the 

discharge will violate its water quality 

requirements, including but not limited 

to, an identification of those water 

quality requirements that will be 

violated.’’ EPA proposed in § 121.14(a), 

that the notification of objection and 

request for hearing from the notified 

neighboring jurisdiction be made 

‘‘within 60 days after receiving notice in 

accordance with § 121.13(c),’’ and 

otherwise that such notification be 

made to the Regional Administrator, the 


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Federal agency, and the certifying 

authority. 

In § 121.14, the Agency is finalizing 

the proposed contents of a notification 

of objection and request for hearing 

from a notified neighboring jurisdiction 

with modifications for purposes of 

adding clarity and more closely 

conforming this regulatory text with 

section 401(a)(2). Consistent with 

revisions throughout §§ 121.14 and 

121.15 in the final rule, EPA revised 

references to ‘‘the neighboring 

jurisdiction’’ in the proposed text of 

§ 121.14 to ‘‘the notified neighboring 

jurisdiction’’ in the final rule to clarify 

that pursuant to section 401(a)(2) only a 

neighboring jurisdiction notified by EPA 

makes a ‘‘will violate’’ determination 

and may provide notification of an 

objection and request a hearing. 

Likewise, consistent with revisions 

throughout Subpart B of the final rule, 

EPA revised § 121.14 of the final rule to 

clarify that the ‘‘discharge’’ that the 

notified neighboring jurisdiction 

considered in its ‘‘will violate’’ 

determination is ‘‘discharge from the 

project’’ in accordance with section 

401(a)(2). Otherwise, EPA is 

maintaining the requirements that the 

notification of objection and request for 

hearing be in writing and include (1) a 

statement that the notified neighboring 

jurisdiction objects to the issuance of 

the Federal license or permit, (2) an 

explanation of the reasons supporting 

the notified neighboring jurisdiction’s 

determination that the discharge from 

the project will violate its water quality 

requirements, including but not limited 

to, an identification of those water 

quality requirements that will be 

violated, and (3) a request for public 

hearing from the Federal agency on the 

notified neighboring jurisdiction’s 

objection. 

EPA received comments regarding the 

contents of a notification of objection 

and request for hearing from a notified 

neighboring jurisdiction. Some 

commenters stated that EPA should 

eliminate any content requirements that 

go beyond the express language in 

section 401(a)(2), including an 

explanation of the reasons supporting 

the determination that the discharge 

will violate water quality requirements. 

More specifically, these commenters 

objected to the requirement that the 

neighboring jurisdiction identify the 

water quality requirements that will be 

violated on the basis that this 

requirement is too burdensome on the 

notified neighboring jurisdiction. Other 

commenters concurred that the 

objection should include identifiable 

and justifiable reasons supporting the 

determination that the discharge will 

violate water quality requirements. In 

addition, some commenters stated that 

the neighboring jurisdiction should be 

required to include a citation to the 

water quality requirements that it 

believes will be violated. 

EPA does not find that § 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 

§ 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. 

Some commenters recommended that 

EPA require the neighboring jurisdiction 

to identify a Federal license or permit 

condition(s) that it thinks would resolve 

the objection in its notification of 

objection and request for hearing. 

Conversely, one commenter stated that 

EPA should not require the neighboring 

jurisdiction to provide conditions that 

would resolve the objection. 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. 

A few commenters asserted that the 

project proponent, as opposed to the 

neighboring jurisdiction, has the burden 

to show that a Federal license or permit 

should be issued. 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) 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. 

Some commenters asserted that the 

neighboring jurisdiction should be 

required to identify the ‘‘potentially 

affected’’ receiving water in an objection 

notification and request for hearing. 

This request appears similar to language 

in the 2020 Rule that required a notified 

neighboring jurisdiction to ‘‘identify the 

receiving waters it determined will be 

affected by the discharge.’’ 40 CFR 

121.12(c)(2) (2020). One of these 

commenters stated that failure to 

identify the receiving water makes it 

impossible to determine the validity of 

the concerns raised to resolve the 

neighboring jurisdiction’s concerns and 

allows the neighboring jurisdiction to 


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raise arbitrary concerns to slow down 

the Federal licensing or permitting 

process. 

EPA declines to require the notified 

neighboring jurisdiction to specifically 

identify affected receiving waters in its 

notification of objection and request for 

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. 

In addition to the requirements 

regarding the content of a notification of 

objection and request for hearing, EPA 

is also finalizing the procedural 

requirements in § 121.14(a) with some 

modifications for purposes of added 

clarity and consistency with section 

401(a)(2). Consistent with the statutory 

language in section 401(a)(2), EPA is 

retaining the requirement that the 

notified neighboring jurisdiction 

provide notification of its objection and 

request for hearing within 60 days of a 

‘‘may affect’’ notice from EPA but is 

updating the internal citation to reflect 

that this notification is provided by the 

Regional Administrator ‘‘pursuant to 

§ 121.13(b)’’ of the final rule. 

Additionally, as mentioned above, EPA 

is removing the requirement in the 

proposed regulatory text that a notified 

neighboring jurisdiction provide 

notification to the certifying authority in 

order to more closely reflect the 

statutory language in section 401(a)(2), 

which does not require notification to 

the certifying authority. 

EPA received comments regarding its 

proposal to require the notified 

neighboring jurisdiction to send the 

‘‘will affect’’ notification to the 

certifying authority, as well as to the 

Federal licensing or permitting agency 

and Regional Administrator. Some 

commenters supported this proposed 

approach. Conversely, another 

commenter stated that the neighboring 

jurisdiction should not be required to 

send the notification to the certifying 

authority because there is no statutory 

basis for this requirement and CWA 

section 401(a)(2) provides no role for the 

certifying authority. As noted, in the 

final rule, 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. 

iii. Withdrawal of Objection Prior to 

Hearing 

CWA section 401(a)(2) states that if a 

notified neighboring jurisdiction 

notifies EPA and the Federal agency ‘‘in 

writing of its objection to the issuance 

of [the] license or permit and requests 

a public hearing on such objection, the 

licensing or permitting agency shall 

hold such a hearing.’’ 33 U.S.C. 

1341(a)(2). Therefore, for a hearing to be 

required under section 401(a)(2), there 

must be (1) a written objection from the 

notified neighboring jurisdiction and (2) 

a request for a public hearing on the 

objection. Id. EPA proposed that if one 

of these elements were not present, then 

the Federal agency would not be 

required to hold a hearing and requested 

comment on whether to develop 

regulatory text for a process where the 

neighboring jurisdiction could 

withdraw its objection and eliminate the 

requirement to hold a public hearing. 87 

FR 35370. 

EPA received numerous comments 

recommending that it include language 

allowing notified neighboring 

jurisdictions to withdraw their 

objections before the hearing, thus, 

eliminating the need to hold a public 

hearing. Some of these commenters 

stated that allowing the neighboring 

jurisdiction to withdraw its objection is 

in line with section 401’s cooperative 

federalism scheme, while other 

commenters stated that allowing for 

withdrawal provides for efficiency in 

the Federal licensing or permitting 

process. 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 § 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 will not need to proceed with a 

public hearing and can move forward 

with issuing the Federal license or 

permit. EPA has also added language to 

this effect at § 121.15(a). It should be 

noted that the Federal agency might 

have to comply with its own public 

notice procedures if it agreed to add 

certain Federal license or permit 

conditions in return for withdrawal of 

the objection. 

h. Objection and Public Hearing Process 

Under Section 401(a)(2) 

CWA section 401(a)(2) requires the 

Federal licensing or permitting agency 

to hold a public hearing on the objection 

of a notified neighboring jurisdiction if 

such neighboring jurisdiction provides 

notification of its objection and request 

for hearing in the required 60-day 

timeframe. 33 U.S.C. 1341(a)(2). As 

explained above, EPA is adding 

language to § 121.15(a) which clarifies 

that if the neighboring jurisdiction 

withdraws its objection, then the 

Federal agency does not have to proceed 

with a public hearing. Otherwise, 

consistent with section 401(a)(2), the 

final rule provides that the Federal 

agency must hold the public hearing 

upon a request for hearing from a 

notified neighboring jurisdiction in 

accordance with the requirements for 

the notification and request for hearing 


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in § 121.14(b) of the final rule. 40 CFR 

121.15(a). 

Section 401(a)(2) does not provide for 

a specific process for the public hearing 

conducted by the Federal licensing or 

permitting agency. It merely states that 

the hearing is public and shall be held 

by the Federal licensing or permitting 

agency. 33 U.S.C. 1341(a)(2). The statute 

further provides that the EPA 

Administrator must submit an 

evaluation and recommendations 

regarding the objection at the hearing. 

Id. Further, section 401(a)(2) states that 

additional evidence may be presented at 

the hearing. After the public hearing, 

the Federal licensing or permitting 

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. Id. Notably, the statute is silent 

as to whether public notice of the public 

hearing is required; the nature of, and 

specific procedures for, the public 

hearing; the need for a court reporter or 

transcript; whether the Federal licensing 

or permitting agency’s decision is 

appealable; and other such matters. 

The Agency proposed to add 

transparency to the neighboring 

jurisdictions process by requiring the 

Federal agency to provide for a 

minimum of a 30-day public notice of 

the hearing, but declined to define the 

type of public hearing that the Federal 

agency must hold. Commenters 

provided various recommendations 

regarding the Federal agency’s public 

hearing, including those addressing the 

notice of hearing, hearing procedures, 

and the location of a hearing. One 

commenter, who supported EPA’s 

approach to the public hearing process, 

suggested that EPA should develop 

hearing procedures that can act as a 

default for Federal agencies that do not 

have public hearing procedures. On the 

other hand, another commenter stated 

that EPA should not impose a minimum 

notice requirement for the public 

hearing. 

EPA is finalizing the proposed 

requirement that the Federal agency 

must provide notice at least 30-days 

prior to the public hearing, but is adding 

text to clarify that only a notified 

neighboring jurisdiction can make a 

request for hearing, and specify that the 

Federal agency must provide such 

public notice to interested parties. 

Consistent with revisions to § 121.14 of 

the final rule, discussed above, EPA is 

adding language to § 121.15 of the final 

rule to make clear that pursuant to 

section 401(a)(2) only a notified 

neighboring jurisdiction may provide 

notification of an objection and request 

a hearing. Additionally, EPA is adding 

language in § 121.15(b) that requires the 

Federal agency to provide public notice 

‘‘to interested parties, including but not 

limited to the notified 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. 

The Agency is otherwise 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. EPA 

also 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. 

As previously mentioned, section 

401(a)(2), also establishes a role for EPA 

at the public hearing, providing that the 

Agency ‘‘shall . . . submit [its] 

evaluation and recommendations with 

respect to any such objection to the 

licensing or permitting agency’’ at the 

public hearing. 33 U.S.C. 1341(a)(2). 

Consistently, EPA is finalizing 

§ 121.15(c) as proposed which mirrors 

the statute by stating that ‘‘[a]t the 

hearing, the Regional Administrator 

shall submit to the Federal agency its 

evaluation and recommendation(s) 

concerning the objection.’’ 40 CFR 

121.15(c). 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 wellsupported 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. 

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 EPA’s evaluation and 

recommendations compared with the 

notified neighboring jurisdiction’s input 


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Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Rules and Regulations 66651 

107Prior to this final rule, in the absence of TAS 

provisions tailored specifically for section 401, 

Tribes had received TAS for section 401 when 

eligible for TAS to administer the section 303(c) 

program for water quality standards. 40 CFR 

131.4(c) (‘‘Where EPA determines that a Tribe is 

eligible to the same extent as a State for purposes 

of water quality standards, the Tribe likewise is 

eligible to the same extent as a State for purposes 

of certifications conducted under Clean Water Act 

section 401.’’). 

or other evidence received at the 

hearing; rather, the section appears to 

contemplate that the Federal agency 

will consider all of the information 

presented in making its decision. 

If the Federal licensing or permitting 

agency determines that additional 

conditions may be necessary to ensure 

compliance with the neighboring 

jurisdiction’s water quality 

requirements, the Federal licensing or 

permitting agency must include those 

conditions in the Federal license or 

permit pursuant to section 401(a)(2). 33 

U.S.C. 1341(a)(2). In addition, if the 

Federal licensing or permitting agency 

cannot include conditions that will 

ensure compliance with applicable 

water quality requirements, the Federal 

agency cannot issue the Federal license 

or permit. Id. EPA is finalizing 

regulatory text that specifically 

incorporates these statutory 

requirements. 40 CFR 121.15(d) and (e). 

If the Federal agency decides that 

conditions are necessary to ensure that 

a project will comply with a 

neighboring jurisdiction’s water quality 

requirements, EPA notes that the 

Federal agency may also have to comply 

with its own public notice and comment 

requirements before finalizing the 

Federal license or permit. 

A few commenters provided input on 

how the Federal agency should engage 

with stakeholders after the conclusion 

of the public hearing. 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). 

EPA did not propose to establish a 

deadline by which the Federal licensing 

or permitting agency must make a 

determination after the public hearing 

on the notified neighboring 

jurisdiction’s objection but requested 

comment on whether such a deadline 

should be established. A few 

commenters recommended that EPA 

create a timeline of the neighboring 

jurisdictions process and specifically 

include timelines for establishing a 

public hearing, making determinations, 

and finishing the post-public hearing 

process. Several commenters 

recommended that EPA establish a 

deadline for the Federal agency to make 

a decision after the public hearing on 

the objection. At least one commenter 

stated that establishing a deadline 

would be inappropriate and 

inconsistent with CWA section 

401(a)(2), arguing 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. 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. 

3. Implementation 

As discussed in detail above, once a 

Federal agency receives a Federal 

license or permit application and a 

certification or waiver, it may proceed 

with the neighboring jurisdictions 

process (i.e., notify EPA as required 

under this final rule). The Agency 

wishes to reiterate that all certifications 

or waivers will trigger the neighboring 

jurisdictions process, even those for 

minor or remote projects. The 

requirement to notify EPA under section 

401(a)(2) depends on the Federal 

agency’s receipt of a Federal license or 

permit application and certification or 

waiver; it does not depend on the 

location of the project or the nature of 

the Federal license or permit. 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 Corps civil works project, 

compliance may involve the Corps 

sending a project study in conjunction 

with a certification or a waiver of 

certification. Ultimately, EPA is 

responsible for determining whether a 

discharge from a project may affect the 

water quality of a neighboring 

jurisdiction. As stated in § 121.13(d) of 

the final rule, and discussed above, a 

Federal agency cannot issue a license or 

permit pending the conclusion of the 

neighboring jurisdictions process, set 

forth in §§ 121.13, 121.14, and 121.15 of 

the final rule. 

Several commenters discussed the 

need for collaboration between EPA and 

other stakeholders prior to the initiation 

of the neighboring jurisdictions process. 

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. 

As discussed above, 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 or project proponents 

or take any action pursuant to section 

401(a)(2) prior to receiving notice from 

the Federal agency of its receipt of the 

application and either a certification or 

waiver. 

L. Treatment in a Similar Manner as a 

State Under Section 401 

1. What is the Agency finalizing? 

The Agency is finalizing the proposed 

provisions enabling Tribes to obtain 

TAS solely for section 401, as well as 

provisions on how Tribes can obtain 

TAS for the limited purpose of 

participating as a neighboring 

jurisdiction under section 401(a)(2).107

Section 121.11 of the final rule includes 

the criteria an applicant Tribe would be 


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108See https://www.epa.gov/tribal/tribesapproved-treatment-state-tas. To date, one Tribe 

with TAS for section 303(c) (Havasupai Tribe in 

Arizona) has declined TAS for section 401. 

required to meet to be treated in a 

similar manner as states, the 

information the Tribe would be required 

to provide in its application to EPA, and 

the procedure EPA would use to review 

the Tribal application. 

Consistent with the requirements 

provided in CWA section 518, the final 

rule requires that four criteria must be 

met for Tribes to obtain TAS for section 

401, including section 401(a)(2). First, 

the Tribe must be federally recognized 

by the U.S. Department of the Interior 

and meet the definitions finalized in 

§ 121.1(d) and (e). Second, the Tribe 

must have a governing body that carries 

out ‘‘substantial governmental duties 

and powers’’ over a defined area. Third, 

the Tribe must have appropriate 

authority to regulate and manage water 

resources within the borders of the 

Tribe’s reservation. Lastly, the Tribe 

must be reasonably expected, in the 

Regional Administrator’s judgment, to 

be capable of administering a section 

401 water quality certification program. 

The Tribe may satisfy the first 

criterion by stating that it is included on 

the list of federally recognized Tribes 

that is published periodically by the 

U.S. Department of the Interior. 

Alternatively, the Tribe may submit 

other appropriate documentation (e.g., if 

the Tribe is not yet included on the U.S. 

Department of the Interior list but is 

federally recognized). 

To meet the second criterion, the 

Tribe would show that it conducts 

‘‘substantial governmental duties and 

powers,’’ which the Agency views as 

performing governmental functions to 

promote the health, safety, and welfare 

of the affected population within a 

defined geographical area. See 54 FR 

39101; 81 FR 65906. This requires a 

descriptive statement that (1) describes 

the form of Tribal government, (2) 

describes the types of essential 

governmental functions currently 

performed by the Tribal governing body, 

including but not limited to, the 

exercise of the power of eminent 

domain, taxation, and police power, and 

(3) identifies the sources of authorities 

to carry out these functions. 

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. This is identical 

to the way Tribes have been 

demonstrating authority for eligibility to 

administer 401 certifications under 

existing TAS regulations, the only 

change being that under the final 

regulations, Tribes will be able to seek 

TAS eligibility for section 401 only. 

Similarly, as with Tribes already 

administering section 401 under prior 

TAS approvals, the authority to issue 

certifications exercised by a Tribe 

authorized under the new regulation 

will, by virtue of the congressional 

delegation, apply throughout the 

reservation area covered by the TAS 

approval, irrespective of land ownership 

or the Tribal membership status of the 

Federal license or permit applicant. See, 

e.g., 81 FR 30190. Therefore, grants or 

waivers of certification by an authorized 

Tribe, as well as any conditions 

included in a certification or denials of 

certification by an authorized Tribe, 

would apply to any application for a 

Federal license or permit throughout the 

relevant reservation without any 

separate need to demonstrate inherent 

Tribal jurisdiction. 

A Tribe may satisfy the fourth 

criterion regarding its capability by 

either (1) providing a description of the 

Tribe’s technical and management skills 

to administer a water quality 

certification program or (2) providing a 

plan that proposes how the Tribe will 

acquire such skills. Additionally, when 

considering Tribal capability, EPA 

would also consider whether the Tribe 

can demonstrate the existence of 

institutions that exercise executive, 

legislative, and judicial functions, and 

whether the Tribe has a history of 

successful managerial performance of 

public health or environmental 

programs. 

Section 121.11 of the final rule is 

intended to ensure that Tribes treated in 

a similar manner as states for the 

purposes of the section 401 water 

quality certification program are 

qualified, consistent with CWA 

requirements, to implement a water 

quality certification program. The 

procedures are meant to provide more 

opportunities for Tribes to engage fully 

in the program and are not intended to 

act as a barrier to Tribal administration 

of the section 401 program. The 

procedures are modeled after the TAS 

regulatory provisions for the CWA 

section 303(c) water quality standards 

(WQS) program, located at 40 CFR 

131.8, and the TAS provisions for the 

CWA section 303(d) impaired water 

listing and total maximum daily load 

program, located at 40 CFR 130.16. The 

WQS TAS regulations, developed in the 

early 1990s, have acted as a model for 

other programs including the section 

303(d) regulations. See 81 FR 65905. 

Additionally, EPA’s TAS regulations 

allow Tribes to simultaneously obtain 

TAS for sections 303(c) and 401. As a 

result, the part 131 and part 130 TAS 

regulations provide an appropriate 

model for this final rule. 

These provisions provide more 

opportunities and clarity for Tribes 

interested in participating in the section 

401 certification process. Although the 

CWA clearly allows Tribes to obtain 

TAS for section 401, current regulations 

and practice treat TAS for section 401 

as an adjunct to TAS for the CWA 

section 303(c) program for water quality 

standards. To date, 83 federally 

recognized Tribes (out of 574) have 

received TAS for section 401 

concurrently with obtaining TAS for 

section 303(c).108 The TAS provisions in 

this final rule do not eliminate or 

modify the section 401 procedures 

already found in part 131. Instead, they 

provide an alternate path for Tribes 

wishing to obtain TAS status only for 

section 401 and not also for section 

303(c). 

Upon receiving TAS for section 401, 

Tribes have two roles. First, Tribes that 

receive section 401 TAS are responsible 

for acting as a certifying authority for 

projects that may result in a discharge 

into waters of the United States on their 

Indian reservations. As certifying 

authorities, Tribes with TAS may grant, 

grant with conditions, deny, or waive 

certification based on whether a 

federally licensed or permitted project 

will comply with sections 301, 302, 303, 

306, and 307 of the CWA and any other 

appropriate requirements of Tribal law. 

See 33 U.S.C. 1341(a)(1) and (d). 

Second, Tribes that receive section 401 

TAS are accorded the status of 

‘‘neighboring jurisdiction’’ for purposes 

of section 401(a)(2). If EPA makes a 

‘‘may affect’’ finding during its 

determination with respect to that 

neighboring jurisdiction, the notified 

neighboring jurisdiction, including 

Tribes with TAS for section 401 and 


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109Section 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). 

110Federal 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. 

Tribes with TAS for section 401(a)(2), 

may object to the issuance of the Federal 

license or permit if they determine that 

a discharge from the project ‘‘will 

violate’’ any of its water quality 

requirements and request a public 

hearing from the Federal licensing or 

permitting agency. 33 U.S.C. 1341(a)(2); 

40 CFR part 121, subpart B. 

2. Summary of Final Rule Rationale and 

Public Comment 

The final rule’s inclusion of TAS 

provisions solely for section 401 and 

401(a)(2) provides alternate paths for 

Tribes to engage in the section 401 

process without also needing to apply 

for section 303(c), promoting 

cooperative federalism and Tribal rights. 

Many of the commenters addressing the 

proposal to add provisions enabling 

Tribes to obtain TAS solely for section 

401 and for section 401(a)(2) expressed 

support for finalizing the proposed TAS 

provisions. These commenters 

supported the inclusion of section 401 

TAS provisions for various reasons 

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 Tribal cultures, and affording 

Tribes more options regarding 

administration of CWA programs. 

EPA appreciates these commenters’ 

support. 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.109

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. 

However, EPA recognizes that some 

Tribes may not desire or have the 

resources to apply for the section 401 

certification program. Pre-proposal 

input suggested that Tribes may wish to 

be notified about and have the ability to 

object to and provide information 

regarding, potential Federal licenses and 

permits that may impact their waters. 

Several Tribal stakeholders have 

expressed concern that Tribes without 

TAS are not able to participate in the 

section 401(a)(2) neighboring 

jurisdictions process. In response to preproposal input, EPA proposed a 

separate TAS provision for the section 

401(a)(2) neighboring jurisdictions 

process. Many commenters from the 

public comment period indicated 

support for the proposed TAS 

provisions, including specifically for 

section 401(a)(2). Commenters asserted 

that waters on reservations are 

susceptible to degradation from 

upstream discharges and that the TAS 

provisions for section 401(a)(2) 

provided a mechanism for objecting and 

requesting a hearing on the issuance of 

Federal licenses and permits for those 

discharges while limiting administrative 

burdens associated with obtaining TAS 

for section 401(a)(1). As a result of this 

input, EPA is finalizing as proposed to 

provide Tribes with an opportunity to 

seek TAS authorization for the limited 

purpose of being a neighboring 

jurisdiction pursuant to section 

401(a)(2). 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 above. 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. See discussion infra. 

Some commenters expressed concern 

about the addition of TAS provisions for 

section 401 and section 401(a)(2). Some 

of these commenters asserted that 

section 401 is limited to ensuring 

compliance with EPA-approved water 

quality standards, and they questioned 

how Tribes without EPA-approved 

water quality standards under section 

303(c) of the Clean Water Act would 

implement section 401. 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 121.1(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.110

Other commenters who raised 

concerns about the TAS provisions 

requested that EPA provide explicit 

acknowledgement of the specific 

circumstances regarding Oklahoma’s 

authority under the Safe, Accountable, 

Flexible, Efficient Transportation Equity 

Act of 2005 (SAFETEA). Some of these 

commenters said that EPA should note 

that the TAS provisions for section 401 

and section 401(a)(2) are subject to 

limitations consistent with this 

authority. 


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111EPA 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). 

EPA holds that the provisions in this 

final rule for obtaining TAS for section 

401 and section 401(a)(2) have no effect 

on the separate TAS requirement of 

section 10211(b) of SAFETEA. 

Additionally, 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 

(June 9, 2022). 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 a 

neighboring 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 authority in the 

neighboring state or Indian reservation 

where the discharge originates that 

exercises authority to grant, grant with 

conditions, deny, or waive certification. 

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. 

3. Implementation 

As this final rule includes TAS 

provisions solely for section 401 and 

section 401(a)(2) for the first time, the 

Agency is developing materials to aid 

the implementation of this aspect of the 

final rule. To implement the TAS 

provisions in this rule, EPA will need to 

communicate how Tribes can apply and 

process any incoming TAS applications 

from Tribes. This implementation 

section also includes discussion of how 

Tribes can implement a certification 

program or participate in the 

neighboring jurisdictions process if they 

obtain TAS for section 401 and/or 

section 401(a)(2). 

Commenters requested that EPA 

provide transparency on TAS 

applications through establishing 

guidelines for applying and identifying 

necessary materials for applications, as 

well as keeping applicant Tribes 

updated on their application status. 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.1 of 

this 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 

entities 111 of the application, including 

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.g., through 

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. 

However, if a Tribe previously 

qualified for TAS for another program 

that also required a Tribe to demonstrate 

authority to regulate reservation water 

quality (i.e., CWA section 303(c) 

program, CWA section 303(d) program, 

CWA section 402 program, or CWA 

section 404 program) and EPA provided 

a notice and comment opportunity, the 

Agency would not require notice on the 

Tribe’s assertion of authority to 

appropriate governmental entities in the 

section 401 TAS application unless 

there were different jurisdictional issues 

or significant new factual or legal 

information relevant to jurisdiction. 

EPA thinks this approach could help 

streamline the process and avoid a 

potentially duplicative notice process. 

This approach will apply prospectively 

only, i.e., where the Tribe obtains TAS 

for the CWA section 303(c), 402, or 404 

programs after the effective date of this 

rule. In other words, if a Tribe first gains 

TAS for another CWA regulatory 

program after this rule is effective, and 

subsequently seeks TAS under this rule, 

additional notice and comment would 

not be required as part of the section 

401 TAS application unless different 

jurisdictional issues or significant new 

factual or legal information relevant to 

jurisdiction are presented in the section 

401 TAS application. If the Regional 

Administrator determines that a Tribe’s 

application meets the requirements in 

§ 121.11(b), the Regional Administrator 

will promptly notify the Tribe in 

writing. A decision by the Regional 

Administrator that a Tribe does not 

meet the requirements in § 121.11(b) 

would not preclude the Tribe from 

resubmitting the application at a future 

date. If the Regional Administrator 


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112See e.g., 33 CFR 325.2 (water quality 

certification on section 404 permits); 18 CFR 4.34 

(water quality certification on FERC hydropower 

licenses). 

113Under 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 of this preamble 

and 85 FR 42245 (July 13, 2020) (‘‘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’’). 

114However, 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. 

determines that a Tribal application is 

deficient or incomplete, EPA will 

identify such deficiencies and gaps so 

the Tribe can make changes as 

appropriate and necessary. 

M. Implementation Considerations 

EPA recognizes that both certifying 

authorities and Federal agencies have 

existing regulations addressing 

implementation of section 401. For 

example, as discussed in section IV.C in 

this preamble, the Agency is aware that 

some certifying authorities have 

regulations defining the contents of a 

request for certification. As a result of 

this rulemaking effort, certifying 

authorities may choose to modify their 

existing regulations (e.g., they may 

choose to define the contents of a 

certification request instead of relying 

on EPA’s definition). Similarly, EPA is 

aware that the Corps and FERC have 

separate section 401 implementation 

regulations addressing their respective 

Federal licensing or permitting 

programs.112 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. 

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. 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 

§ 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 rerequest 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.113 A ‘‘reasonable period of 

time’’ determined under the 2020 Rule 

prior to the effective date of the final 

rule would 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 § 121.6(e) of 

the final rule, or avail itself to an 

automatic extension to the reasonable 

period of time pursuant to § 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 § 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 § 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.114 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 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. 

N. Severability 

The purpose of this section is to 

clarify the Agency’s intent with respect 

to the severability of provisions of this 

rule in the event of litigation. In the 

event of a stay or invalidation of any 

part of this rule, the Agency’s intent is 

to preserve the remaining portions of 

the rule to the fullest possible extent. To 

dispel any doubt regarding EPA’s intent 

and to inform how the regulation would 

operate if severed, EPA has added the 

following regulatory text at § 121.19: 

‘‘The provisions of this part are separate 

and severable from one another. If any 

provision is stayed or determined to be 

invalid, the remaining provisions shall 

continue in effect.’’ The Agency would 

have adopted each portion of this rule 

independent of the other portions. As 

explained below, the Agency carefully 

crafted this rule so that each provision 

or element of the rule is capable of 

operating independently. Moreover, the 

Agency has organized the rule so that if 

any provision or element of this rule is 

determined by judicial review or 

operation of law to be invalid, that 

partial invalidation will not render the 

remainder of this rule invalid. 

Section 121.3 regarding the scope of 

review for certification decisions is a 

good example of how the Agency 

structured the final rule so its various 

provision and elements operate 

independently. The provisions 

regarding scope operate entirely 

independently from the other provisions 

of this rule, as § 121.3, which concerns 

scope, is not cross-referenced or 

necessary for the operation of any other 

section of part 121 or any other EPA 


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115 In fact, the Agency’s interpretation of which 

waters may be considered in certification is not 

reflected in the regulatory text, including the text 

regarding scope of certification at § 121.3. 

116 Due to ongoing litigation on the 2020 Rule, 

EPA considers two baselines in the economic 

analysis. 

regulation. The other provisions of this 

rule operate the same regardless of 

whether the scope of certification is 

water quality-related impacts from the 

full activity subject to the Federal 

license or permit or only its point 

source discharges. First, the rule’s 

provisions regarding when certification 

is required (§ 121.2) would be the same 

regardless of the scope of certification. 

The Agency’s rationale for when 

certification is required does not rely on 

and is independent of the Agency’s 

rationale for the proper scope of 

certification. What triggers a 

requirement to apply for certification is 

a distinct issue, independent from what 

the certifying authority can consider in 

its subsequent certification decision. 

Second, this rule’s definition of water 

quality requirements remains valid 

regardless of the scope of certification. 

The rule defines ‘‘water quality 

requirements’’ to mean ‘‘any limitation, 

standard, or other requirement under 

sections 301, 302, 303, 306, and 307 of 

the Clean Water Act, any Federal and 

state or Tribal laws or regulations 

implementing those sections, and any 

other water quality-related requirement 

of state or Tribal law.’’ Section 121.1(j). 

The first two clauses (listing the 

sections of the CWA identified in 

section 401 and the state or Tribal laws 

implementing them) clearly hold true 

regardless of scope of certification. In 

addition, regardless of the scope of 

certification (i.e., either the full activity 

subject to the Federal license or permit 

or only its point source discharges), in 

order to qualify as an ‘‘appropriate’’ 

requirement of state or Tribal law, the 

requirement must be ‘‘water qualityrelated.’’ Additionally, the issue of 

which waters to consider when acting 

on a request for certification is 

independent of the issue of the proper 

scope of certification. Under either a 

‘‘discharge-only’’ or activity-based scope 

of certification, the question remains 

whether certifying authorities may 

consider impacts to state or Tribal 

waters beyond ‘‘navigable waters.’’ 

EPA’s interpretation regarding which 

waters may be considered is also 

severable from all other aspects of this 

final rule. No provision of this final rule 

operates differently depending on 

which waters a certifying authority may 

consider when acting on a request for 

certification.115 Further, the Agency’s 

interpretation regarding scope of the 

neighboring jurisdictions process in 

section 401(a)(2) is independent and 

does not rely on the Agency’s 

interpretation regarding the scope of 

certification. As explained in this 

preamble, the certification process and 

the neighboring jurisdictions process are 

two distinct processes with distinct 

statutory text and legislative history. 

EPA’s interpretation of the scope of the 

neighboring jurisdictions process 

expressly accounts for these differences. 

The other topics addressed in this 

rulemaking all function the same 

regardless of the scope of certification. 

Many are 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 function the same 

regardless of scope. All the topics 

addressed in this rulemaking beyond 

scope are important provisions that EPA 

would have promulgated absent 

promulgation of a rule changing the 

scope of certification. As explained 

throughout this preamble, these other 

aspects of the rule provide independent 

benefits to the certification process 

including regulatory certainty and 

transparency, efficient certification 

reviews, and enhanced cooperative 

federalism. Regardless of the scope of 

certification, for the reasons articulated 

in this preamble, EPA would adopt the 

same pre-filing meeting requirement 

(§ 121.4); the same minimum contents 

for a request for certification (§ 121.5); 

the same process for determining the 

reasonable period of time (§ 121.6); the 

same four ways a certifying authority 

may act on a request (grant, grant with 

conditions, deny, or expressly waive) 

(§ 121.7); the same limitations regarding 

Federal agency review (§ 121.8); the 

same standard for when inadvertent 

waiver occurs (§ 121.9); the same 

procedure and limitations for modifying 

a grant of certification (§ 121.10); the 

same requirements for Indian Tribes to 

administer a certification program 

(§ 121.11); the same procedures 

regarding the neighboring jurisdictions 

process (§§ 121.12 through 121.15); the 

same additional procedures for when 

EPA acts as a certifying authority 

(§§ 121.16 and 121.17); the same rules 

regarding EPA review and advice 

(§ 121.18), and would otherwise take the 

same approach as it did in this final 

rule. EPA’s rationales for adopting these 

provisions apply equally regardless of 

the scope of certification and these 

provisions would function equally 

under any scope of certification. 

Likewise, the other provisions of this 

rule operate independently from each 

other and are intended to be severable. 

For example, the contents of a request 

for certification (§ 121.5) function 

independently from the procedures for 

setting and extending the reasonable 

period of time (§ 121.6). The process 

and limitations for modifying a grant of 

certification (§ 121.10) have no bearing 

on a federally recognized Tribe’s ability 

to apply for TAS for section 401 

(§ 121.11). The limitations on Federal 

agency review (§ 121.8) have no bearing 

on when a request for certification is 

required (§ 121.2). Were any element of 

these provisions stayed or invalidated 

by a reviewing court, the elements that 

remained in effect would continue to 

provide vital improvements to the 

certification process including 

regulatory certainty and transparency, 

efficient certification reviews, enhanced 

cooperative federalism, and where 

appropriate, reasonable flexibility to 

adapt to changing circumstances. The 

examples provided throughout this 

section are illustrative, rather than 

exhaustive, and EPA intends each 

portion of the rule to be independent 

and severable. Further, if the 

application of any portion of this rule to 

a particular circumstance is determined 

to be invalid, the Agency intends that 

the rule remain applicable to all other 

circumstances. 

V. Economic Analysis 

Pursuant to Executive Orders 12866 

(Regulatory Planning and Review) and 

14094 (Modernizing Regulatory 

Review), EPA has prepared an economic 

analysis (Economic Analysis for the 

Final Rule) to inform the public of 

potential effects associated with this 

rulemaking. This analysis is not 

required by the CWA. 

To support the final rulemaking, EPA 

prepared an Economic Analysis for the 

Final Rule and other related rule 

analyses to assess potential impacts of 

the rule. These analyses seek to evaluate 

the benefits and costs of the rulemaking 

and the effects of the rule on vulnerable 

groups and small entities. The 

Economic Analysis for the Final Rule 

presents an overview of practice under 

the 1971 Rule and 2020 Rule 

(baselines),116 a description of the final 

rule changes, and an assessment of the 

potential impacts of the final 

rulemaking on project proponents, 

certifying authorities, and Federal 

agencies as changes from each baseline 

of regulatory practice to the new 

requirements. Appendix A in the 

Economic Analysis for the Final Rule 

provides a plain-language comparison of 

the 1971 Rule, 2020 Rule, and final 


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117 Docket ID No. EPA–HQ–OW–2021–0302. 

118 Docket ID No. EPA–HQ–OW–2022–0128. 

119Arkansas, California Water Board of San 

Diego, Idaho, Mississippi, New Hampshire, Oregon, 

and Washington. 120For more detailed information about the 

Agency’s methodology for selecting random 

samples and conducting the machine reading 

analysis, please see Clean Water Act Section 401 

Water Quality Certification Improvement Rule— 

Final Rule, Memorandum to the File, Certification 

Decision PDF Extraction Effort, available in Docket 

ID No. EPA–HQ–OW–2022–0128. 

rulemaking provisions in a table format. 

Within the Economic Analysis for the 

Final Rule, the Agency included 

discussion of the environmental benefits 

and process costs with examples 

relative to the final rulemaking 

provisions. EPA also assessed 

environmental justice impacts of the 

rulemaking on vulnerable communities 

and impacts on small entities. The 

Agency also prepared an Information 

Collection Request Supporting 

Statement which describes the overall 

burden of the section 401 regulations, 

thus including any new burdens 

resulting from this final rule. See 

section VI.B of this preamble. 

Section 401 certification decisions 

have varying effects on certifying 

authorities and project proponents. 

However, the Agency has limited data 

regarding the number of requests for 

certification submitted and the 

certification decisions taken on requests 

for certification (i.e., whether 

certifications were granted, granted with 

conditions, denied, or waived). The 

Agency does not maintain a national 

database of certifying authority 

decisions and therefore did not have 

enough data available to perform a fully 

quantitative economic analysis. Given 

the absence of data related to section 

401 regulations, EPA performed a 

qualitative analysis of the section 401 

certification process under the 1971 

Rule, the 2020 Rule, and under the final 

rulemaking. 

The Agency reviewed information 

from several sources to characterize 

section 401 baseline conditions and 

understand potential impacts of the 

regulatory changes. Specifically, the 

Agency investigated State and territory 

websites and assembled available 

information concerning section 401 fees 

and certification decisions. EPA also 

conducted a focused review of preproposal input letters 117 and public 

comments 118 to extract any information 

concerning economic impacts of section 

401 and key issues identified during 

implementation of section 401. 

Section 401 is a direct grant of 

authority to states and authorized 

Tribes. Accordingly, EPA does not 

provide program oversight to state or 

Tribal programs. Nevertheless, EPA 

reviewed state and territory websites to 

investigate data availability on 

certification decisions and found that 

seven certifying authorities have section 

401 certification decision documents 

publicly available. The Agency 

reviewed a random sample of 200 

certification decisions from seven 

different state websites 119 and used a 

machine reading approach to determine 

whether the Agency could derive any 

information on timing and certification 

decisions to inform this rulemaking.120

Due to significant data limitations, EPA 

was unable to use the review of the 

certification decisions to make any 

conclusions to inform this rulemaking. 

More information about the analysis 

that EPA performed when reviewing 

these decision documents can be found 

in the Economic Analysis for the Final 

Rule. 

Within the Economic Analysis, the 

Agency describes the various Federal 

licenses and permits that require section 

401 certification and the potential 

actions that certifying authorities may 

take pursuant to their section 401 

authority. Additionally, the Agency 

summarized the annual number of 

licenses and permits that require section 

401 certification under different Federal 

authorities to determine the extent of 

licensing and permitting actions within 

the section 401 universe. These types of 

information are used in the Economic 

Analysis for the Final Rule to describe 

implementation practices and trends 

under the baselines and serve as the 

basis for assessing impacts of the final 

rulemaking. 

In determining the potential effects of 

the final rulemaking, EPA described the 

impacts of rule revisions in several key 

areas including pre-filing meetings, 

contents of requests for certification, 

reasonable period of time, neighboring 

jurisdictions, and Tribal provisions for 

implementing section 401. The 1971 

Rule baseline did not include a prefiling meeting request requirement. 

However, because pre-filing meetings 

allow for early discussion of project 

details, such meetings would ultimately 

be expected to reduce burden elsewhere 

in the section 401 certification process. 

The 2020 Rule did not provide 

certifying authorities with the option to 

waive or shorten the pre-filing meeting 

request requirement. The Agency 

anticipates that the pre-filing meeting 

request provision will provide 

flexibility for certifying authorities to 

decide whether to require pre-filing 

meeting requests and whether to hold 

pre-filing meetings based on project 

complexity and other factors. Relative to 

both the 1971 Rule and 2020 Rule 

baselines, the Agency expects that the 

minimum content requirements for all 

requests for certifications will support a 

transparent and efficient certification 

process. Additionally, relative to each of 

the two baselines, the changes 

concerning the reasonable period of 

time for certification review will 

balance equities between certifying 

authorities and Federal agencies and 

provide flexibility for certifying 

authorities and Federal agencies to 

determine the optimal length for the 

reasonable period of time or any 

extensions, provided they do not exceed 

one year from the date the request for 

certification was received. For example, 

the final rule will allow certifying 

authorities to ensure that the reasonable 

period of time is informed by the size 

and complexity of the project, the 

certifying authority’s available resources 

(e.g., staff size), public notice and 

comment requirements, and 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). Allowing the certifying 

authority and Federal agency to 

negotiate a reasonable period of time at 

or before the beginning of the 

certification process (subject to a sixmonth default) is also likely to improve 

the efficiency of the review process. The 

final rule also provides greater clarity 

regarding the process to protect 

neighboring jurisdiction waters (e.g., by 

specifying the contents of a notification 

from a Federal agency to EPA), which is 

expected to increase its efficiency. This 

clarity and efficiency are expected when 

using the 1971 Rule as the baseline, as 

well as for the 2020 Rule baseline 

(though potentially to a lesser extent 

due to some updated provisions in the 

2020 Rule). Neither the 1971 Rule nor 

the 2020 Rule included TAS provisions. 

Final revisions permitting Tribes to 

obtain TAS solely for section 401 and, 

if desired, to only obtain TAS for the 

purpose of participating as neighboring 

jurisdictions under section 401(a)(2), 

will provide Tribes with a greater ability 

to protect their water resources from the 

adverse effects of pollution from 

federally licensed or permitted projects. 

In some areas, the rulemaking would 

revive practices that had been widely 

implemented for 50 years before the 

2020 Rule. Specifically, the rule would 

return the scope of a certifying 

authority’s section 401 review as 

encompassing the ‘‘activity’’ which is 

consistent with longstanding Agency 

and certifying authority practice and 


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allows certifying authorities to protect 

their waters from the widest range of 

impacts. The Agency is finalizing a 

certification modification process, 

allowing certifying authorities and 

Federal agencies the flexibility to 

mutually agree on circumstances 

warranting modification. Provided that 

certification modification efforts are 

appropriately coordinated, the 

modification process under the final 

rule would allow certifying authorities 

to adapt to changes in environmental 

and regulatory conditions, and provide 

needed flexibility to accommodate 

changed circumstances after issuance of 

a grant of certification, with or without 

conditions. 

EPA anticipates that the rulemaking 

will enhance the ability of states and 

Tribes to protect their water resources 

by clarifying key components of the 

water quality certification process and 

improving coordination between 

Federal agencies, certifying authorities, 

and project proponents. 

VI. Statutory and Executive Order 

Reviews 

Additional information about these 

statutes and Executive orders can be 

found at https://www.epa.gov/lawsregulations/laws-and-executive-orders. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 14094: Modernizing Regulatory 

Review 

This action is a ‘‘significant regulatory 

action’’ as defined in Executive Order 

12866, as amended by Executive Order 

14094. Accordingly, EPA submitted this 

action to the Office of Management and 

Budget (OMB) for Executive Order 

12866 review. Documentation of any 

changes made in response to Executive 

Order 12866 review is available in the 

docket for this action. The Agency 

prepared an economic analysis of the 

potential impacts associated with this 

action, and concluded that the benefits 

of the rule justify the costs. This 

analysis, the Economic Analysis for the 

Final Rule, is available in the docket for 

this action (Docket ID No. EPA–HQ– 

OW–2022–0128) and is briefly 

summarized in section V in this 

preamble. 

B. Paperwork Reduction Act (PRA) 

The information collection activities 

in this rulemaking have been submitted 

for approval to the Office of 

Management and Budget (OMB) under 

the PRA. The Information Collection 

Request (ICR) document that EPA 

prepared has been assigned EPA ICR 

number 2603.08 (OMB Control No. 

2040–0295). You can find a copy of the 

ICR in the docket for this rule, and it is 

briefly summarized here. 

The information collected under 

section 401 is used by certifying 

authorities and EPA to evaluate 

potential water quality impacts from 

federally licensed or permitted projects. 

When states or Tribes with TAS act as 

the certifying authority, the primary 

collection of this information is 

performed by the Federal agencies 

issuing the licenses or permits or the 

states and Tribes acting as certifying 

authorities. When EPA acts as the 

certifying authority or evaluates 

potential neighboring jurisdiction 

impacts, the information is collected by 

EPA. Information collected directly by 

EPA under section 401 in support of the 

section 402 NPDES program is already 

captured under existing ICR No. 

0229.255 (OMB Control No. 2040–0004). 

The information collected under section 

518(e) is used by EPA to determine 

whether a Tribe is eligible for TAS for 

section 401 or TAS for section 401(a)(2). 

Information collected directly by EPA 

under section 518(e) in support of the 

process for Tribes to obtain TAS for 

CWA section 303(c) and section 401 

simultaneously is already captured 

under existing ICR No. 0988.14 (OMB 

Control No. 2040–0049). The 

information collection requirements are 

not enforceable until OMB approves 

them. 

The revisions clarify the nature of the 

information project proponents must 

include in a request for section 401 

certification. They also contain a prefiling meeting request requirement for 

project proponents which may be 

waived or shortened by a certifying 

authority. The revisions also provide 

Tribes with the ability to obtain TAS 

solely for either section 401 or section 

401(a)(2). Total annual burden for 

respondents (project proponents and 

certifying authorities and Tribes 

applying for TAS) are anticipated to be 

861,274 hours with the associated 

annual labor costs being approximately 

$48 million. EPA expects these 

revisions to provide greater clarity 

regarding section 401 requirements, to 

reduce the overall preparation time 

spent by a project proponent on requests 

for certification, and to reduce the 

review time for certifying authorities. 

In the interest of transparency, EPA is 

providing the following summary of the 

relevant portions of the burden 

assessment associated with EPA’s 

existing certification regulations. EPA 

does not expect any measurable change 

in information collection burden 

associated with the rulemaking changes. 

Respondents/affected entities: Project 

proponents, state and Tribal reviewers 

(certifying authorities), Tribes applying 

for TAS. 

Respondent’s obligation to respond: 

Required to obtain section 401 water 

quality certification; voluntary for 

Tribes to apply for TAS. 

Estimated number of respondents: 

154,006 responses from 77,146 

respondents annually. 

Frequency of response: Variable (one 

per Federal license or permit 

application, or only once) depending on 

type of information collected. 

Total estimated burden: 861,274 

hours (per year). Burden is defined at 5 

CFR 1320.3(b). 

Total estimated cost: $48 million (per 

year). 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in 40 

CFR are listed in 40 CFR part 9. When 

OMB approves this ICR, the Agency will 

announce that approval in the Federal 

Register and publish a technical 

amendment to 40 CFR part 9 to display 

the OMB control number for the 

approved information collection 

activities contained in this final rule. 

C. Regulatory Flexibility Act (RFA) 

I certify that this final rule will not 

have a significant economic impact on 

a substantial number of small entities 

under the RFA. The small entities 

subject to the requirements of this 

action are project proponents that are 

small businesses applying for Federal 

licenses or permits subject to section 

401 certification, which includes 

construction, manufacturing, mining, 

and utility businesses. Section 401 

requires project proponents to obtain a 

water quality certification from the 

certifying authority where the potential 

discharge originates or will originate 

before it may obtain such Federal 

license or permit. 

EPA is not able to quantify the 

impacts of the rulemaking on small 

entities due to several data limitations 

and uncertainties, which are described 

within the Economic Analysis for the 

Final Rule, available in the docket for 

this rulemaking. However, EPA is 

including 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. See the Economic 


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Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Rules and Regulations 66659 

Analysis for the Final Rule for details of 

the qualitative analysis. 

D. Unfunded Mandates Reform Act 

(UMRA) 

This action does not contain an 

unfunded mandate of $100 million or 

more as described in UMRA, 2 U.S.C. 

1531–1538, and does not significantly or 

uniquely affect small governments. 

While this action creates enforceable 

duties for the private sector, the cost 

does not exceed $100 million or more. 

This action does not create enforceable 

duties for state and Tribal governments. 

See the Economic Analysis for the Final 

Rule in the docket for further discussion 

on UMRA. 

E. Executive Order 13132: Federalism 

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. 

EPA is finalizing updates to its CWA 

section 401 regulation to provide greater 

clarity and flexibility for certifying 

authorities in relation to acting on prefiling meeting requests, contents of 

requests for certification, acting within 

the reasonable period of time, modifying 

a grant of certification, and participating 

in the neighboring jurisdictions process. 

EPA is also finalizing clarifications to 

the scope of Federal agency review; 

however, nothing in EPA’s rulemaking 

would preempt state law. These 

regulatory clarifications and revisions 

will reinforce the authority granted to 

states by CWA section 401 to protect 

their water quality, which had been 

exercised by the states prior to 

implementation of the 2020 Rule. 

Prior to proposing a rule in June 2022, 

EPA solicited recommendations and 

conducted pre-proposal outreach, such 

as virtual listening sessions, where 

many state and local governments, 

intergovernmental associations, and 

other associations representing state and 

local governments participated. 

Specifically, EPA hosted webinar-based 

listening sessions for pre-proposal input 

on June 14, June 15, June 23, and June 

24, 2021, with over 400 participants 

from most states and a few territories. 

Furthermore, EPA accommodated 

requests for listening sessions with 

representatives from the Association of 

Clean Water Administrators, the 

Association of State Wetland Managers, 

the Environmental Council of the States, 

Western States Water Council, Indiana 

Department of Environmental 

Management, Maryland Department of 

the Environment, New Mexico 

Environmental Department, New York 

Department of Environmental 

Conservation, Oregon Department of 

Environmental Quality, Virginia 

Department of Environmental Quality, 

and Washington Department of Ecology. 

All pre-proposal input letters and 

summaries of the webinar-based 

listening sessions are available in 

Docket ID No. EPA–HQ–OW–2021– 

0302. These webinars, meetings, and 

input letters provided a wide and 

diverse range of interests, positions, and 

recommendations to the Agency. 

After publishing the proposed rule in 

the Federal Register, stakeholders were 

encouraged to submit comment letters 

during a 60-day public comment period, 

and EPA held a public hearing on July 

18, 2022 for all stakeholders to provide 

public comment on the proposed rule. 

Additionally, EPA hosted three listening 

sessions specifically for state and 

territory government representatives on 

June 15, 22, and 28, 2022—there were 

over 175 attendees at these listening 

sessions. Summaries of the public 

hearing sessions and of the input 

received during the state/territory 

listening sessions can be found in the 

docket for this rulemaking. 

Furthermore, EPA reviewed and 

responded to the public comment letters 

from state, territory, and local 

governments in a Response to 

Comments document that can also be 

found in the docket for this rulemaking. 

Comments on the proposed rule were 

submitted by various state and territory 

governmental agencies, predominately 

state environmental agencies or 

departments, with some comments from 

state departments of agriculture, 

wildlife (and fish and game), public 

health, and transportation. In addition, 

some comments were submitted by 

governors’ offices and attorneys general, 

with a few joint comments from 

multiple state attorneys general. A few 

comments were submitted by statespecific, state-level water boards or 

departments. Comments were also 

submitted by several national and 

regional state associations. Many of 

these commenters were generally 

supportive of the rulemaking effort and 

elements of the proposed rule, but also 

offered suggestions and/or critiques of 

specific aspects of the proposed rule. 

Commenters in support of the proposed 

rule generally critiqued the 2020 Rule or 

offered support for the 1971 Rule 

approach to section 401. These 

commenters argued that the proposed 

rule was an improvement over the 2020 

Rule in terms of cooperative federalism 

and/or the purported approach to the 

CWA and discussed the importance of 

state involvement under the CWA and 

section 401, with several commenters 

discussing specific approaches in their 

states. On the other hand, other state 

commenters, including a large group of 

state attorneys general that signed onto 

one letter, voiced support for the 2020 

Rule, arguing that the narrowed scope of 

certification review introduced in the 

2020 Rule was necessary to prevent the 

abuse or misuse of CWA section 401 by 

certifying authorities. 

As discussed throughout this 

preamble, EPA acknowledges that the 

final rule may change how states and 

territories administer the section 401 

program, but anticipates that the 

adjustments incorporated into the final 

rule will provide states and territories 

with additional flexibility (1) in waiving 

or shortening the pre-filing meeting 

request requirement, (2) in defining 

additional content requirements for 

requests for certification, (3) in 

negotiating the length of the reasonable 

period of time (including development 

of categorical agreements), (4) in 

reviewing the water quality-related 

impacts from the activity, (5) in 

development of their certification 

decision documents, (6) in the ability to 

modify a grant of certification, and (7) 

in the neighboring jurisdictions process 

if a potential discharge originating in 

another jurisdiction may affect their 

water quality. Finally, the final rule 

provides clarity for states acting as 

certifying authorities on several key 

aspects of the certification process, 

including (1) the minimum contents of 

a request for certification, (2) the start of 

the reasonable period of time (and the 

default length of the reasonable period 

of time), (3) the water quality-related 

scope of review, (4) the recommended 

contents of certification decisions, (5) 

the extent of Federal agency review, (6) 

the limits to modifications of 

certifications, and (7) the neighboring 

jurisdictions process. 

As mentioned above, all state and 

local government comment letters and 

recommendations received during the 

comment period are included in the 

rulemaking docket (Docket ID No. EPA– 

HQ–OW–2022–0128). 


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F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action may have implications for 

Tribal governments. However, it will 

neither impose substantial direct 

compliance costs on federally 

recognized Tribal governments, nor 

preempt Tribal law. This action may 

change how Tribes with TAS for section 

401 administer the section 401 program, 

but it will not have an administrative 

impact on Tribes on whose behalf EPA 

issues certifications. As discussed in the 

preamble, EPA expects this final rule to 

expand and further clarify the 

opportunities for Tribal participation in 

the CWA section 401 water quality 

certification process. 

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. 

As previously mentioned, the Agency 

initiated a Tribal consultation and 

coordination process before proposing a 

rule by sending a ‘‘Notification of 

Consultation and Coordination’’ letter, 

dated June 7, 2021, to all 574 of the 

Tribes federally recognized at that time 

(see Docket ID No. EPA–HQ–OW–2021– 

0302). The letter invited Tribal leaders 

and designated consultation 

representatives to participate in the 

Tribal consultation and coordination 

process for this rulemaking. In addition 

to two national Tribal webinars held on 

June 29 and July 7, 2021, the Agency 

convened other listening sessions, that 

Tribal members and representatives 

attended, for certifying authorities and 

the public. EPA continued outreach and 

engagement with Tribes and sought 

other opportunities to provide 

information and hear feedback from 

Tribes at national and regional Tribal 

meetings during and after the end of the 

consultation period. The Agency did not 

receive any consultation requests. All 

Tribal and Tribal organization letters 

and webinar feedback are included in 

the pre-proposal docket (Docket ID No. 

EPA–HQ–OW–2021–0302), and a 

summary of the Tribal consultation and 

coordination effort may be found in the 

docket for this action (Docket ID No. 

EPA–HQ–OW–2022–0128). Many Tribal 

feedback letters or meeting participants 

expressed an interest in receiving 

additional information and in continued 

engagement with the Agency during 

development of the proposed 

rulemaking; however, most of these 

Tribal representatives highlighted other 

ongoing rulemakings that also required 

their engagement. 

After publishing the proposed rule in 

the Federal Register, stakeholders were 

encouraged to submit comment letters 

during a 60-day public comment period, 

and EPA held a public hearing on July 

18, 2022 for all stakeholders to provide 

public comment on the proposed rule. 

Additionally, EPA hosted three listening 

sessions specifically for Tribal 

representatives on June 15, 22, and 28, 

2022—there were over 75 attendees at 

these listening sessions. Summaries of 

the public hearing sessions and of the 

input received during the Tribal 

listening sessions can be found in the 

docket for this rulemaking. 

Furthermore, EPA reviewed and 

responded to the public comment letters 

from Tribal representatives in a 

Response to Comments document that 

can also be found in the docket for this 

rulemaking. 

Most Tribal commenters expressed 

support for the proposed rule’s return to 

pre-2020 rule practices to restore Tribal 

sovereignty for the protection of their 

water resources. Many Tribal 

commenters supported inclusion of a 

section 401 TAS process independent of 

TAS for section 303(c), asserting that it 

would increase Tribal authority related 

to the neighboring jurisdictions process 

and increase Tribal regulatory capability 

as certifying authorities. Many Tribal 

commenters supported EPA’s return to 

the Agency’s longstanding ‘‘activity as a 

whole’’ scope of review. Many Tribal 

commenters also expressed support for 

the proposed rule’s approach to 

extensions to the reasonable period of 

time, as well as the proposed removal of 

the regulatory prohibition on 

withdrawal and resubmission of 

requests for certification. Some Tribal 

commenters supported increased 

flexibility for modifications. 

While many of the Tribal commenters 

supported the proposed rule, some 

Tribal commenters expressed 

disagreement or concern with portions 

of the proposed rule. A few Tribal 

commenters said that they were 

concerned with the inability to 

participate in the neighboring 

jurisdictions process if EPA does not 

commit in the regulation to consulting 

with Tribes during EPA’s 30-day review 

period. Another issue some Tribal 

commenters raised was the need for 

more clarity regarding Tribal 

enforcement of section 401 certification 

conditions. Additionally, a few Tribal 

commenters expressed concern that the 

default 60-day reasonable period of time 

would not be enough time for their 

review of large, complex projects. As 

mentioned throughout this preamble, 

the Agency expects the adjustments 

made from the proposed rule to the final 

rule to address any Tribal representative 

concerns while continuing to provide 

the flexibility and clarity that many 

Tribal representatives requested. For 

more information about the Tribal 

consultation and coordination efforts, 

please see the final ‘‘Summary Report of 

Tribal Consultation and Engagement for 

the Clean Water Act Section 401 Water 

Quality Certification Improvement 

Rule’’ in the docket (Docket ID No. 

EPA–HQ–OW–2022–0128). 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

EPA interprets Executive Order 13045 

as applying only to those regulatory 

actions that concern environmental 

health or safety risks that EPA has 

reason to believe may 

disproportionately affect children, per 

the definition of ‘‘covered regulatory 

action’’ in section 2–202 of the 

Executive order. 

Therefore, this action is not subject to 

Executive Order 13045 because it does 

not concern an environmental health 

risk or safety risk. Since this action does 

not concern human health, EPA’s Policy 

on Children’s Health also does not 

apply. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not a ‘‘significant 

energy action’’ because it is not likely to 

have a significant adverse effect on the 

supply, distribution, or use of energy. 

See the Economic Analysis for the Final 

Rule in the docket for further discussion 

on Executive Order 13211. 

I. National Technology Transfer and 

Advancement Act 

This final rulemaking does not 

involve technical standards. 


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121Under CWA section 401(a)(1), certifying 

authorities are required to establish procedures for 

public notice and, to the extent it deems 

appropriate, procedures for public hearings. 33 

U.S.C. 1341(a)(1). 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations and Executive 

Order 14096: Revitalizing Our Nation’s 

Commitment to Environmental Justice 

for All 

EPA believes that it is not practicable 

to assess whether the human health or 

environmental conditions that exist 

prior to this action result in 

disproportionate and adverse effects on 

communities with environmental justice 

concerns. The Economic Analysis for 

the Final Rule includes information 

about the data limitations and 

uncertainties that exist regarding both 

baseline environmental conditions and 

how stakeholders, including certifying 

authorities, may respond to this final 

rule. 

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. 

One of the ways the Agency addresses 

environmental justice concerns through 

the final rule is through the pre-filing 

meeting request requirement, which 

provides a mechanism to ensure 

certifying authorities can request and 

receive information needed to protect 

their water resources and ensure the 

activity will comply with applicable 

water quality requirements, including 

through consideration of information 

and input from potentially affected 

communities with environmental justice 

concerns during early engagement. In 

addition to informing the certification 

process, this also advances the goals of 

Executive Order 14096, including 

‘‘meaningful involvement.’’ 

Additionally, the final rule empowers 

certifying authorities to make a wellinformed decision that may affect 

communities with environmental justice 

concerns because under the final rule, 

the certifying authority can determine 

the additional contents of requests for 

certification (as long as those contents 

are relevant to the water quality-related 

impacts from the activity and are 

identified prior to when a project 

proponent submits a request). Starting 

the certifying authority’s review of a 

request for certification with the 

necessary information about water 

quality-related impacts from the activity 

promotes environmental justice and 

transparency in the certification 

process. This also enables certifying 

authorities to share a greater level of 

detail with the public (including any 

communities that may be impacted by a 

proposed project), so that participants in 

the public notice and comment process 

can provide better informed input.121

Under the final rule’s collaborative 

approach for determining the reasonable 

period of time, certifying authorities can 

take the needs of potentially affected 

communities into account when 

determining the amount of time they 

need to review and evaluate the 

potential impacts of a proposed project 

on the communities’ water resources 

(e.g., a certifying authority may suggest 

a longer reasonable period of time to 

facilitate outreach to communities or to 

conduct studies on a proposed project’s 

impact on local communities). 

Additionally, the ‘‘activity’’ approach 

for scope of review has the potential to 

benefit communities with 

environmental justice concerns by 

ensuring that the certifying authority 

can broadly review the potential water 

quality impacts on affected 

communities. 

Furthermore, the TAS provisions for 

section 401 as a whole or only for 

section 401(a)(2) give Tribes additional 

options to obtain TAS, as well as more 

opportunities to provide input and 

voice any water quality concerns during 

the section 401 process. Lastly, when 

EPA is acting as the certifying authority, 

the Agency is finalizing the proposed 

updates to the public notice provision to 

facilitate participation by the broadest 

number of potentially interested 

stakeholders, including communities 

with environmental justice concerns. 

The information supporting this 

Executive order review, including a 

description of data limitations and 

uncertainties, is contained in the 

Economic Analysis for the Final Rule, 

which can be found in the docket for 

this action and is briefly summarized in 

section V in this preamble. 

K. Congressional Review Act (CRA) 

This action is subject to the CRA, and 

EPA will submit a rule report to each 

House of Congress and to the 

Comptroller General of the United 

States. This action is not a ‘‘major rule’’ 

as defined by 5 U.S.C. 804(2). 

List of Subjects 

40 CFR Part 121 

Environmental protection, 

Administrative practice and procedure, 

Intergovernmental relations, Water 

pollution control. 

40 CFR Part 122 

Environmental protection, 

Administrative practice and procedure, 

Confidential business information, 

Hazardous substances, Reporting and 

recordkeeping requirements, Water 

pollution control. 

40 CFR Part 124 

Environmental protection, 

Administrative practice and procedure, 

Air pollution control, Hazardous waste, 

Indians—lands, Reporting and 

recordkeeping requirements, Water 

pollution control, Water supply. 

Michael S. Regan, 

Administrator. 

For the reasons set forth in the 

preamble, EPA amends 40 CFR parts 

121, 122, and 124 as follows: 

■ 1. Revise part 121 to read as follows: 

PART 121—STATE CERTIFICATION OF 

ACTIVITIES REQUIRING A FEDERAL 

LICENSE OR PERMIT 

Sec. 

Subpart A—General 

121.1 Definitions. 

121.2 When certification is required. 

121.3 Scope of certification. 

121.4 Pre-filing meeting requests. 

121.5 Request for certification. 

121.6 Reasonable period of time. 

121.7 Certification decisions. 

121.8 Extent of Federal agency review. 

121.9 Failure or refusal to act. 

121.10 Modification to a grant of 

certification. 

121.11 Requirements for Indian Tribes to 

administer a water quality certification 

program. 

Subpart B—Neighboring Jurisdictions 

121.12 Notification to the Regional 

Administrator. 

121.13 Determination of effects on 

neighboring jurisdictions. 

121.14 Objection from notified neighboring 

jurisdiction and request for a public 

hearing. 

121.15 Public hearing and Federal agency 

evaluation of objection. 

Subpart C—Certification by the 

Administrator 

121.16 When the Administrator certifies. 

121.17 Public notice and hearing. 

Subpart D—Review and Advice 

121.18 Review and advice. 

Subpart E—Severability 

121.19 Severability 

Authority: 33 U.S.C. 1251 et seq. 

Subpart A—General 

§ 121.1 Definitions. 

As used in this part, the following 

terms shall have the meanings 

indicated: 


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(a) Administrator means the 

Administrator, Environmental 

Protection Agency (EPA). 

(b) Certifying authority means the 

entity responsible for certifying 

compliance with applicable water 

quality requirements in accordance with 

Clean Water Act section 401. 

(c) Federal agency means any agency 

of the Federal Government to which 

application is made for a Federal license 

or permit that is subject to Clean Water 

Act section 401. 

(d) Federal Indian Reservation, Indian 

reservation, or reservation means all 

land within the limits of any Indian 

reservation under the jurisdiction of the 

United States Government, 

notwithstanding the issuance of any 

patent, and including rights-of-way 

running through the reservation. 

(e) Indian Tribe or Tribe means any 

Indian Tribe, band, group, or 

community recognized by the Secretary 

of the Interior and exercising 

governmental authority over a Federal 

Indian Reservation. 

(f) License or permit means any 

license or permit issued or granted by 

an agency of the Federal Government to 

conduct any activity which may result 

in any discharge into waters of the 

United States. 

(g) 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), other than the jurisdiction in 

which the discharge originates or will 

originate. 

(h) Project proponent means the 

applicant for a Federal license or 

permit, or the entity seeking 

certification. 

(i) Regional Administrator means the 

Regional designee appointed by the 

Administrator, Environmental 

Protection Agency. 

(j) Water quality requirements means 

any limitation, standard, or other 

requirement under sections 301, 302, 

303, 306, and 307 of the Clean Water 

Act, any Federal and state or Tribal laws 

or regulations implementing those 

sections, and any other water qualityrelated requirement of state or Tribal 

law. 

§ 121.2 When certification is required. 

Certification or waiver is required for 

any Federal license or permit that 

authorizes any activity which may 

result in any discharge from a point 

source into waters of the United States. 

§ 121.3 Scope of certification. 

(a) When a certifying authority 

reviews a request for certification, the 

certifying authority shall evaluate 

whether the activity will comply with 

applicable water quality requirements. 

The certifying authority’s evaluation is 

limited to the water quality-related 

impacts from the activity subject to the 

Federal license or permit, including the 

activity’s construction and operation. 

(b) Consistent with the scope of 

review identified in paragraph (a) of this 

section, a certifying authority shall 

include any conditions in a grant of 

certification necessary to assure that the 

activity will comply with applicable 

water quality requirements. 

§ 121.4 Pre-filing meeting requests. 

The project proponent shall request a 

pre-filing meeting with the certifying 

authority at least 30 days prior to 

submitting a request for certification in 

accordance with the certifying 

authority’s applicable submission 

procedures, unless the certifying 

authority waives or shortens the 

requirement for a pre-filing meeting 

request. 

§ 121.5 Request for certification. 

(a) Where a project proponent is 

seeking certification from any certifying 

authority, the request for certification 

shall include the following minimum 

contents: 

(1) If the request for certification is for 

an individual Federal license or permit, 

it shall be in writing, signed, and dated 

and shall include the following: 

(i) A copy of the Federal license or 

permit application submitted to the 

Federal agency; and 

(ii) Any readily available water 

quality-related materials that informed 

the development of the application. 

(2) If the request for certification is for 

the issuance of a general Federal license 

or permit, it shall be in writing, signed, 

and dated and shall include the 

following: 

(i) A copy of the draft Federal license 

or permit; and 

(ii) Any readily available water 

quality-related materials that informed 

the development of the draft Federal 

license or permit. 

(b) Where a project proponent is 

seeking certification from the Regional 

Administrator, if not already included 

in the request for certification in 

accordance with paragraph (a) of this 

section, a request for certification shall 

also include the following, as 

applicable: 

(1) A description of the proposed 

activity, including the purpose of the 

proposed activity and the type(s) of 

discharge(s) that may result from the 

proposed activity; 

(2) The specific location of any 

discharge(s) that may result from the 

proposed activity; 

(3) A map or diagram of the proposed 

activity site, including the proposed 

activity boundaries in relation to local 

streets, roads, and highways; 

(4) A description of current activity 

site conditions, including but not 

limited to relevant site data, 

photographs that represent current site 

conditions, or other relevant 

documentation; 

(5) The date(s) on which the proposed 

activity is planned to begin and end 

and, if known, the approximate date(s) 

when any discharge(s) may commence; 

(6) A list of all other Federal, 

interstate, Tribal, state, territorial, or 

local agency authorizations required for 

the proposed activity and the current 

status of each authorization; and 

(7) Documentation that a pre-filing 

meeting request was submitted to the 

certifying authority in accordance with 

applicable submission procedures, 

unless the pre-filing meeting request 

requirement was waived. 

(c) Where a project proponent is 

seeking certification from a certifying 

authority other than the Regional 

Administrator, and that certifying 

authority has identified contents of a 

request for certification in addition to 

those identified in paragraph (a) of this 

section that are relevant to the water 

quality-related impacts from the 

activity, the project proponent shall 

include in the request for certification 

those additional contents identified 

prior to when the request for 

certification is made. 

(d) Where a project proponent is 

seeking certification from a certifying 

authority other than the Regional 

Administrator, and that certifying 

authority has not identified contents of 

a request for certification in addition to 

those identified in paragraph (a) of this 

section that are relevant to the water 

quality-related impacts from the 

activity, the project proponent shall 

include in the request for certification 

those additional contents identified in 

paragraph (b) of this section. 

§ 121.6 Reasonable period of time. 

(a) The reasonable period of time 

begins on the date that the certifying 

authority receives a request for 

certification, as defined in § 121.5, in 

accordance with the certifying 

authority’s applicable submission 

procedures. The certifying authority 

shall send written confirmation to the 

project proponent and Federal agency of 

the date that the request for certification 

was received. 


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Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Rules and Regulations 66663 

(b) The Federal agency and the 

certifying authority may jointly agree in 

writing to the reasonable period of time 

for the certifying authority to act on the 

request for certification, provided the 

reasonable period of time does not 

exceed one year from the date that the 

request for certification was received. 

Such written agreements may establish 

categorical reasonable periods of time. 

(c) If the Federal agency and the 

certifying authority do not agree in 

writing on the length of the reasonable 

period of time, the reasonable period of 

time shall be six months. 

(d) If a longer period of time is 

necessary to accommodate the certifying 

authority’s public notice procedures or 

force majeure events (including, but not 

limited to, government closure or 

natural disasters), upon written 

notification by the certifying authority 

to the Federal agency prior to the end 

of the reasonable period of time, the 

reasonable period of time shall be 

extended by the period of time 

necessitated by public notice 

procedures or the force majeure event. 

In such written notification to the 

Federal agency, the certifying authority 

shall identify how much additional time 

is required and provide a justification 

for such extension. Such an extension 

shall not cause the reasonable period of 

time to exceed one year from the date 

that the request for certification was 

received. 

(e) The Federal agency and certifying 

authority may agree in writing to extend 

the reasonable period of time for any 

reason, provided that the extension 

shall not cause the reasonable period of 

time to exceed one year from the date 

that the request for certification was 

received. 

§ 121.7 Certification decisions. 

(a) A certifying authority may act on 

a request for certification in one of four 

ways: grant certification, grant 

certification with conditions, deny 

certification, or expressly waive 

certification. 

(b) A certifying authority shall act on 

a request for certification within the 

scope of certification and within the 

reasonable period of time. 

(c) A grant of certification shall be in 

writing and should include the 

following: 

(1) Identification of the decision as a 

grant of certification; 

(2) Identification of the applicable 

Federal license or permit; 

(3) A statement that the activity will 

comply with water quality 

requirements; and 

(4) An indication that the certifying 

authority complied with its public 

notice procedures established pursuant 

to Clean Water Act section 401(a)(1). 

(d) A grant of certification with 

conditions shall be in writing and 

should include the following: 

(1) Identification of the decision as a 

grant of certification with conditions; 

(2) Identification of the applicable 

Federal license or permit; 

(3) A statement explaining why each 

of the included conditions is necessary 

to assure that the activity will comply 

with water quality requirements; and 

(4) An indication that the certifying 

authority complied with its public 

notice procedures established pursuant 

to Clean Water Act section 401(a)(1). 

(e) A denial of certification shall be in 

writing and should include the 

following: 

(1) Identification of the decision as a 

denial of certification; 

(2) Identification of the applicable 

Federal license or permit; 

(3) A statement explaining why the 

certifying authority cannot certify that 

the activity will comply with water 

quality requirements, including but not 

limited to a description of any missing 

water quality-related information if the 

denial is based on insufficient 

information; and 

(4) An indication that the certifying 

authority complied with its public 

notice procedures established pursuant 

to Clean Water Act section 401(a)(1). 

(f) An express waiver shall be in 

writing and should include the 

following: 

(1) Identification of the decision as an 

express waiver of certification; 

(2) Identification of the applicable 

Federal license or permit; 

(3) A statement that the certifying 

authority expressly waives its authority 

to act on the request for certification; 

and 

(4) An indication that the certifying 

authority complied with its public 

notice procedures established pursuant 

to Clean Water Act section 401(a)(1). 

(g) If the certifying authority 

determines that no water quality 

requirements are applicable to the 

activity, the certifying authority shall 

grant certification. 

§ 121.8 Extent of Federal agency review. 

To the extent a Federal agency verifies 

compliance with the requirements of 

Clean Water Act section 401, its review 

is limited to whether: the appropriate 

certifying authority issued the 

certification decision; the certifying 

authority confirmed it complied with its 

public notice procedures established 

pursuant to Clean Water Act section 

401(a)(1); and the certifying authority 

acted on the request for certification 

within the reasonable period of time. 

§ 121.9 Failure or refusal to act. 

(a) 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. 

(b) If the Federal agency determines 

that the certifying authority did not act 

on a request for certification within the 

reasonable period of time, the Federal 

agency shall promptly notify the 

certifying authority and project 

proponent in writing that the 

certification requirement has been 

waived in accordance with § 121.8. 

Such notice shall satisfy the project 

proponent’s requirement to obtain 

certification. 

§ 121.10 Modification to a grant of 

certification. 

(a) Provided that the Federal agency 

and the certifying authority agree in 

writing that the certifying authority may 

modify a grant of certification (with or 

without conditions), the certifying 

authority may modify only the agreedupon portions of the certification. The 

certifying authority is not required to 

obtain the Federal agency’s agreement 

on the language of the modification. 

(b) The certifying authority shall not, 

through a modification pursuant to 

paragraph (a) of this section: 

(1) Revoke a grant of certification 

(with or without conditions); or 

(2) Change a grant of certification 

(with or without conditions) into a 

denial or waiver of certification. 

§ 121.11 Requirements for Indian Tribes to 

administer a water quality certification 

program. 

(a) The Regional Administrator may 

accept and approve a Tribal application 

for purposes of administering a water 

quality certification program if the Tribe 

meets the following criteria: 

(1) The Indian Tribe is recognized by 

the Secretary of the Interior and meets 

the definitions in § 121.1(d) and (e); 

(2) The Indian Tribe has a governing 

body carrying out substantial 

governmental duties and powers; 

(3) The water quality certification 

program to be administered by the 

Indian Tribe pertains to the 

management and protection of water 

resources that are within the borders of 

the Indian reservation and held by the 

Indian Tribe, within the borders of the 

Indian reservation and held by the 

United States in trust for Indians, within 

the borders of the Indian reservation 

and held by a member of the Indian 

Tribe if such property interest is subject 

to a trust restriction on alienation, or 

otherwise within the borders of the 

Indian reservation; and 


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(4) The Indian Tribe is reasonably 

expected to be capable, in the Regional 

Administrator’s judgment, of carrying 

out the functions of an effective water 

quality certification program in a 

manner consistent with the terms and 

purposes of the Clean Water Act and 

applicable regulations in this chapter. 

(b) Requests by an Indian Tribe for 

administration of a water quality 

certification program should be 

submitted to the appropriate EPA 

Regional Administrator. The application 

shall include the following information, 

provided that where the Tribe has 

previously qualified for eligibility or 

‘‘treatment as a state’’ under another 

EPA-administered program, the Tribe 

need only provide the required 

information that has not been submitted 

in a previous application: 

(1) A statement that the Tribe is 

recognized by the Secretary of the 

Interior. 

(2) A descriptive statement 

demonstrating that the Tribal governing 

body is currently carrying out 

substantial governmental duties and 

powers over a defined area. The 

statement should: 

(i) Describe the form of Tribal 

government; 

(ii) Describe the types of 

governmental functions currently 

performed by the Tribal governing body 

such as, but not limited to, the exercise 

of police powers affecting (or relating to) 

the health, safety, and welfare of the 

affected population, taxation, and the 

exercise of the power of eminent 

domain; and 

(iii) Identify the source of the Tribal 

government’s authority to carry out the 

governmental functions currently being 

performed. 

(3) A descriptive statement of the 

Tribe’s authority to regulate water 

quality. The statement should include: 

(i) A map or legal description of the 

area over which the Tribe asserts 

authority to regulate surface water 

quality; and 

(ii) A statement by the Tribe’s legal 

counsel or equivalent official that 

describes the basis for the Tribe’s 

assertion of authority and may include 

copies of documents such as Tribal 

constitutions, by-laws, charters, 

executive orders, codes, ordinances, 

and/or resolutions that support the 

Tribe’s assertion of authority. 

(4) A narrative statement describing 

the capability of the Indian Tribe to 

administer an effective water quality 

certification program. The narrative 

statement should include: 

(i) A description of the Indian Tribe’s 

previous management experience that 

may include the administration of 

programs and services authorized by the 

Indian Self-Determination and 

Education Assistance Act (25 U.S.C. 

450, et seq.), the Indian Mineral 

Development Act (25 U.S.C. 2101, et 

seq.), or the Indian Sanitation Facility 

Construction Activity Act (42 U.S.C. 

2004a); 

(ii) A list of existing environmental or 

public health programs administered by 

the Tribal governing body and copies of 

related Tribal laws, policies, and 

regulations; 

(iii) A description of the entity (or 

entities) which exercise the executive, 

legislative, and judicial functions of the 

Tribal government; 

(iv) A description of the existing, or 

proposed, agency of the Indian Tribe 

which will assume primary 

responsibility for establishing and 

implementing a water quality 

certification program; and 

(v) A description of the technical and 

administrative capabilities of the staff to 

administer and manage an effective 

water quality certification program or a 

plan which proposes how the Tribe will 

acquire additional administrative and 

technical expertise. The plan must 

address how the Tribe will obtain the 

funds to acquire the administrative and 

technical expertise. 

(5) Additional documentation 

required by the Regional Administrator 

which, in the judgment of the Regional 

Administrator, is necessary to support a 

Tribal application. 

(c) The procedure for processing a 

Tribe’s application is as follows: 

(1) The Regional Administrator shall 

process an application of an Indian 

Tribe submitted pursuant to paragraph 

(b) of this section in a timely manner. 

The Regional Administrator shall 

promptly notify the Indian Tribe of 

receipt of the application. 

(2) Except as provided in paragraph 

(c)(4) of this section, within 30 days 

after receipt of the Tribe’s application, 

the Regional Administrator shall 

provide appropriate notice. The notice 

shall: 

(i) Include information on the 

substance and basis of the Tribe’s 

assertion of authority to regulate the 

quality of reservation waters; 

(ii) Be provided to all appropriate 

governmental entities; and 

(iii) Provide 30 days for comments to 

be submitted on the Tribal application. 

Comments shall be limited to the Tribe’s 

assertion of authority. 

(3) If a Tribe’s asserted authority is 

subject to a competing or conflicting 

claim, the Regional Administrator, after 

due consideration, and in consideration 

of other comments received, shall 

determine whether the Tribe has 

adequately demonstrated that it meets 

the requirements of paragraph (a)(3) of 

this section. 

(4) Where, after November 27, 2023, 

EPA has determined that a Tribe 

qualifies for treatment in a similar 

manner as a state for the Clean Water 

Act section 303(c) Water Quality 

Standards Program, Clean Water Act 

section 303(d) Impaired Water Listing 

and Total Maximum Daily Loads 

Program, Clean Water Act section 402 

National Pollutant Discharge 

Elimination System Program, or Clean 

Water Act section 404 Dredge and Fill 

Permit Program, and has provided 

notice and an opportunity to comment 

on the Tribe’s assertion of authority to 

appropriate governmental entities as 

part of its review of the Tribe’s prior 

application, no further notice to 

governmental entities, as described in 

paragraph (c)(2) of this section, shall be 

provided with regard to the same Tribe’s 

application for the water quality 

certification program, unless the 

application presents to the EPA 

Regional Administrator different 

jurisdictional issues or significant new 

factual or legal information relevant to 

jurisdiction. 

(5) Where the Regional Administrator 

determines that a Tribe meets the 

requirements of this section, they shall 

promptly provide written notification to 

the Indian Tribe that the Tribe is 

authorized to administer the water 

quality certification program. 

(d) An Indian Tribe may submit a 

Tribal application for purposes of 

administering only the Clean Water Act 

section 401(a)(2) portion of a water 

quality certification program. 

Subpart B—Neighboring Jurisdictions 

§ 121.12 Notification to the Regional 

Administrator. 

(a) Within five days of the date that 

it has received both the application and 

either a certification or waiver for a 

Federal license or permit, the Federal 

agency shall provide written 

notification to the appropriate Regional 

Administrator. 

(1) The notification shall include a 

copy of the certification or waiver and 

the application for the Federal license or 

permit. 

(2) The notification shall also contain 

a general description of the proposed 

project, including but not limited to the 

Federal license or permit identifier, 

project location (e.g., latitude and 

longitude), a project summary including 

the nature of any discharge and size or 

scope of activity, and whether the 

Federal agency is aware of any 

neighboring jurisdiction providing 


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comment about the project. If the 

Federal agency is aware that a 

neighboring jurisdiction provided 

comment about the project, it shall 

include a copy of those comments in the 

notification. 

(b) If the Regional Administrator 

determines there is a need for 

supplemental information to make a 

determination about potential 

neighboring jurisdiction effects 

pursuant to Clean Water Act section 

401(a)(2), the Regional Administrator 

may make a written request to the 

Federal agency that such information be 

provided in a timely manner for EPA’s 

determination, and the Federal agency 

shall obtain that information from the 

project proponent and forward the 

additional information to the 

Administrator within such timeframe. 

(c) The Regional Administrator may 

enter into an agreement with a Federal 

agency regarding the manner of this 

notification process and the provision of 

supplemental information. 

§ 121.13 Determination of effects on 

neighboring jurisdictions. 

(a) Within 30 days after the Regional 

Administrator receives notice in 

accordance with § 121.12(a), the 

Regional Administrator shall determine 

whether a discharge from the project 

may affect water quality in a 

neighboring jurisdiction. 

(b) If the Regional Administrator 

determines that the discharge from the 

project may affect water quality in a 

neighboring jurisdiction, within 30 days 

after receiving notice in accordance 

with § 121.12(a), the Regional 

Administrator shall notify the 

neighboring jurisdiction, the Federal 

agency, and the project proponent in 

accordance with paragraph (c) of this 

section. 

(c) Notification from the Regional 

Administrator shall be in writing and 

shall include: 

(1) A statement that the Regional 

Administrator has determined that a 

discharge from the project may affect 

the neighboring jurisdiction’s water 

quality; 

(2) A copy of the Federal license or 

permit application and related 

certification or waiver; and 

(3) A statement that the neighboring 

jurisdiction has 60 days after such 

notification to notify the Regional 

Administrator and the Federal agency, 

in writing, if it has determined that the 

discharge will violate any of its water 

quality requirements, to object to the 

issuance of the Federal license or 

permit, and to request a public hearing 

from the Federal agency. 

(d) A Federal license or permit shall 

not be issued pending the conclusion of 

the process described in this section, 

and §§ 121.14 and 121.15. 

§ 121.14 Objection from notified 

neighboring jurisdiction and request for a 

public hearing. 

(a) If a neighboring jurisdiction 

notified by the Regional Administrator 

pursuant to § 121.13(b) determines that 

a discharge from the project will violate 

any of its water quality requirements, it 

shall notify the Regional Administrator 

and the Federal agency in accordance 

with paragraph (b) of this section within 

60 days after receiving such notice from 

the Regional Administrator. 

(b) Notification from the notified 

neighboring jurisdiction shall be in 

writing and shall include: 

(1) A statement that the notified 

neighboring jurisdiction objects to the 

issuance of the Federal license or 

permit; 

(2) An explanation of the reasons 

supporting the notified neighboring 

jurisdiction’s determination that the 

discharge from the project will violate 

its water quality requirements, 

including but not limited to, an 

identification of those water quality 

requirements that will be violated; and 

(3) A request for a public hearing from 

the Federal agency on the notified 

neighboring jurisdiction’s objection. 

(c) The notified neighboring 

jurisdiction may withdraw its objection 

prior to the public hearing. If the 

notified neighboring jurisdiction 

withdraws its objection, it shall notify 

the Regional Administrator and the 

Federal agency, in writing, of such 

withdrawal. 

§ 121.15 Public hearing and Federal 

agency evaluation of objection. 

(a) Upon a request for hearing from a 

notified neighboring jurisdiction in 

accordance with § 121.14(b), the Federal 

agency shall hold a public hearing on 

the notified neighboring jurisdiction’s 

objection to the Federal license or 

permit, unless the objection is 

withdrawn in accordance with 

§ 121.14(c). 

(b) The Federal agency shall provide 

public notice at least 30 days in advance 

of the hearing to interested parties, 

including but not limited to the notified 

neighboring jurisdiction, the certifying 

authority, the project proponent, and 

the Regional Administrator. 

(c) At the hearing, the Regional 

Administrator shall submit to the 

Federal agency its evaluation and 

recommendation(s) concerning the 

objection. 

(d) The Federal agency shall consider 

recommendations from the notified 

neighboring jurisdiction and the 

Regional Administrator, and any 

additional evidence presented to the 

Federal agency at the hearing, and 

determine whether additional Federal 

license or permit conditions may be 

necessary to ensure that any discharge 

from the project will comply with the 

neighboring jurisdiction’s water quality 

requirements. If such conditions may be 

necessary, the Federal agency shall 

include them in the Federal license or 

permit. 

(e) If additional Federal license or 

permit conditions cannot ensure that 

the discharge from the project will 

comply with the notified neighboring 

jurisdiction’s water quality 

requirements, the Federal agency shall 

not issue the Federal license or permit. 

Subpart C—Certification by the 

Administrator 

§ 121.16 When the Administrator certifies. 

(a) Certification or waiver by the 

Administrator is required where no 

state, Tribe, or interstate agency has 

authority to give such a certification. 

(b) When acting pursuant to this 

section, the Administrator shall comply 

with the requirements of Clean Water 

Act section 401 and this part. 

§ 121.17 Public notice and hearing. 

(a) Within 20 days of the date that the 

request for certification was received, 

the Administrator shall provide public 

notice of the request for certification. 

Following such public notice, the 

Administrator shall provide an 

opportunity for public comment. 

(b) If the Administrator determines 

that a public hearing on a request for 

certification is appropriate, the 

Administrator shall schedule such 

hearing at an appropriate time and place 

and, to the extent practicable, give all 

interested and potentially affected 

parties the opportunity to present 

evidence or testimony in person or by 

other means. 

Subpart D—Review and Advice 

§ 121.18 Review and advice. 

Upon the request of any Federal 

agency, certifying authority, or project 

proponent, the Administrator shall 

provide any relevant information on 

applicable effluent limitations, or other 

limitations, standards, regulations, or 

requirements, or water quality criteria, 

and shall, when requested by any 

Federal agency, certifying authority, or 

project proponent, comment on any 

methods to comply with such 

limitations, standards, regulations, 

requirements, or criteria. 


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66666 Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Rules and Regulations 

Subpart E—Severability 

§ 121.19 Severability. 

The provisions of this part are 

separate and severable from one 

another. If any provision is stayed or 

determined to be invalid, the remaining 

provisions shall continue in effect. 

PART 122—EPA ADMINISTERED 

PERMIT PROGRAMS: THE NATIONAL 

POLLUTANT DISCHARGE 

ELIMINATION SYSTEM 

■ 2. The authority citation for part 122 

continues to read as follows: 

Authority: The Clean Water Act, 33 U.S.C. 

1251 et seq. 

■ 3. Amend § 122.4 by revising 

paragraph (b) to read as follows: 

§ 122.4 Prohibitions (applicable to State 

NPDES programs, see § 123.25). 

* * * * * 

(b) When the applicant is required to 

obtain a State or other appropriate 

certification under section 401 of the 

CWA and that certification has not been 

obtained or waived; 

* * * * * 

■ 4. Amend § 122.44 by revising 

paragraph (d)(3) to read as follows: 

§ 122.44 Establishing limitations, 

standards, and other permit conditions 

(applicable to State NPDES programs, see 

§ 123.25). 

* * * * * 

(d) * * * 

(3) Conform to the conditions in a 

State certification under section 401 of 

the CWA when EPA is the permitting 

authority; 

* * * * * 

■ 5. Amend § 122.62 by revising 

paragraph (a)(3)(iii) to read as follows: 

§ 122.62 Modification or revocation and 

reissuance of permits (applicable to State 

programs, see § 123.25). 

* * * * * 

(a) * * * 

(3) * * * 

(iii) For changes based upon modified 

State certifications of NPDES permits, 

see § 121.10 of this chapter. 

* * * * * 

PART 124—PROCEDURES FOR 

DECISIONMAKING 

■ 6. The authority citation for part 124 

continues to read as follows: 

Authority: Resource Conservation and 

Recovery Act, 42 U.S.C. 6901 et seq.; Safe 

Drinking Water Act, 42 U.S.C. 300f et seq.; 

Clean Water Act, 33 U.S.C. 1251 et seq.; 

Clean Air Act, 42 U.S.C. 7401 et seq. 

■ 7. Amend § 124.53 by revising 

paragraphs (b) through (e) to read as 

follows: 

§ 124.53 State certification. 

* * * * * 

(b) Consistent with the requirements 

set forth in §§ 121.4 and 121.5 of this 

chapter, applications for individual 

permits may be forwarded by the 

Regional Administrator to the certifying 

State agency with a request to act on the 

request for certification consistent with 

§ 121.7 of this chapter. 

(c) If State certification has not been 

requested by the time the draft permit 

is prepared, the Regional Administrator 

shall send the certifying State agency a 

request for certification consistent with 

§ 121.5 of this chapter and include a 

copy of the draft permit. 

(d) State certification shall be granted 

or denied within the reasonable period 

of time as required under CWA section 

401(a)(1). The State shall send a notice 

of its action, including a copy of any 

certification, to the applicant and the 

Regional Administrator. 

(e) State certification on a draft permit 

may include a statement of the extent to 

which each condition of the draft permit 

can be made less stringent without 

violating the requirements of State law, 

including water quality standards. 

■ 8. Amend § 124.54 by revising 

paragraphs (a) and (b) to read as follows: 

§ 124.54 Special provisions for State 

certification and concurrence on 

applications for section 301(h) variances. 

(a) When an application for a permit 

incorporating a variance request under 

CWA section 301(h) is submitted to a 

State, the appropriate State official shall 

either: 

(1) Deny the request for the CWA 

section 301(h) variance (and so notify 

the applicant and EPA) and, if the State 

is an approved NPDES State and the 

permit is due for reissuance, process the 

permit application under normal 

procedures; or 

(2) Forward a copy of the certification 

required under CWA section 401(a)(1) to 

the Regional Administrator. 

(b) When EPA issues a tentative 

decision on the request for a variance 

under CWA section 301(h), and no 

certification has been received under 

paragraph (a) of this section, the 

Regional Administrator shall forward 

the tentative decision to the State. If the 

State fails to deny or grant certification 

and concurrence under paragraph (a) of 

this section within the reasonable 

period of time provided in CWA section 

401(a)(1), certification shall be waived 

and the State shall be deemed to have 

concurred in the issuance of a CWA 

section 301(h) variance. 

* * * * * 

■ 9. Amend § 124.55 by: 

■ a. Revising paragraph (a); 

■ b. Removing paragraph (b); 

■ c. Redesignating paragraphs (c) 

through (f) as paragraphs (b) through (e), 

respectively; and 

■ d. Revising newly redesignated 

paragraphs (b) and (c). 

The revisions read as follows: 

§ 124.55 Effect of State certification. 

(a) When certification is required 

under CWA section 401(a)(1), no final 

permit shall be issued: 

(1) If certification is denied; or 

(2) Unless the final permit 

incorporates the conditions specified in 

the certification. 

(b) A State may not condition or deny 

a certification on the grounds that State 

law allows a less stringent permit 

condition. 

(c) A condition in a draft permit may 

be changed during agency review in any 

manner consistent with a corresponding 

certification. No such changes shall 

require EPA to submit the permit to the 

State for recertification. 

* * * * * 

[FR Doc. 2023–20219 Filed 9–26–23; 8:45 am] 

BILLING CODE 6560–50–P 


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