Economic Analysis for the Final Clean
Water Act Section 401 Water Quality
Certification Improvement Rule

U.S. Environmental Protection Agency


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Table of Contents

Table of Contents................................................................................................................................. 1

List of Tables	4

List of Figures....................................................................................................................................,,,5

Abbreviations...................................................................................................................................... 6

1	Executive Summary...................................................................................................................... 7

2	Introduction	8

3	Baseline Conditions	10

3.1	Description of Certifying Authority Determinations	10

3.2	Information from Certifying Authorities	12

3.2.1	Quantitative Data on the Number of Section 401 Certification Requests and Decisions .. 12

3.2.2	Certification Processing Fees	14

3.2.3	Time to Issue a Certification Decision	15

3.2.4	Time Required for the Public Comment Process	16

3.2.5	Certification Decision PDF Extraction Effort	17

3.3	Federal Agency Data on License and Permits by Certifying Authority	23

3.4	License and Permit Data Characterization	24

3.4.1	Section 404 Permits	24

3.4.2	Section 402 NPDES Permits	25

3.4.3	Interstate Natural Gas Pipeline and Hydropower Project Licenses	25

3.4.4	Rivers and Harbors Act Sections 9 and 10 Permits	25

3.4.5	Nuclear Power Plant Licenses	25

3.4.6	Mining Licenses	25

3.4.7	Tennessee Valley Authority Shoreline Permits	26

3.4.8	Alcohol and Tobacco Tax and Trade Bureau Permits for Alcohol Producers and
Manufacturers	26

3.5	Limitations and Uncertainties	26

3.5.1	Information from Certifying Authority Websites, Pre-proposal Input, and Public Comment
	26

3.5.2	Federal License and Permit Summary	26

4	Potential Effect of Final Regulatory Revisions............................................................................. 27

4.1 When Section 401 Certification Is Required	28

4.1.1 Summary of Provision	28

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4.1.2 Potential Impacts of the Provision	28

4.2	Pre-filing Meeting Requests	28

4.2.1	Summary of Provision	28

4.2.2	Potential Impacts of the Provision	29

4.3	Request for Certification	31

4.3.1	Summary of Provision	31

4.3.2	Potential Impacts of the Provision	33

4.4	Reasonable Period of Time	35

4.4.1	Summary of Provision	35

4.4.2	Potential Impacts of the Provision	36

4.5	Scope of Certification	38

4.5.1	Summary of Provision	38

4.5.2	Potential Impacts of the Provision	39

4.6	Certification Decisions	42

4.6.1	Summary of Provision	42

4.6.2	Potential Impacts of the Provision	43

4.7	Federal Agency Review	44

4.7.1	Summary of Provision	44

4.7.2	Potential Impacts of the Provision	45

4.8	EPA's Roles Under Section 401	46

4.8.1	Summary of Provision	46

4.8.2	Potential Impacts of the Provision	47

4.9	Modifications	48

4.9.1	Summary of Provision	48

4.9.2	Potential Impacts of the Provision	49

4.10	Neighboring Jurisdictions Process	50

4.10.1	Summary of Provision	50

4.10.2	Potential Impacts of the Provision	52

4.11	TAS and Other Tribal Issues	53

4.11.1	Summary of Provision	53

4.11.2	Potential Impacts of the Provision	54

4.12	Potential Effects on Federal Agency and Certifying Authority Regulations and Guidance	54

4.12.1 Potential Effects on Federal Agency Regulations	54

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4.12.2 Potential Effects on Certifying Authority Regulations and Guidance	54

4.13	Information Collection Request Burden Estimates	56

4.14	Summary of Potential Effects	57

4.14.1	Incremental Benefits	59

4.14.2	Incremental Costs	60

4.14.3	Net Benefits	61

5	Environmental Justice ................................................................................................................ 62

5.1	Impacts on Communities with Environmental Justice Concerns	63

5.2	Tribal Impacts	65

6	Data Limitations and Uncertainty............................................................................................... 67

7	Statutory and Executive Order Requirements	68

7.1	Unfunded Mandate Reform Act	68

7.2	Executive Order 12898 Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations	69

7.3	Executive Orders 12866 Regulatory Planning and Review and 14094 Modernizing Regulatory
Review70

7.4	Regulatory Flexibility Act and Small Business Regulatory Enforcement Fairness Act	70

7.4.1	Final Rule Provisions that May Have Some Impact on Project Proponents	70

7.4.2	Anticipated Impacts to Small Entities	74

7.5	Executive Order 13211 Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use	78

8	References................................................................................................................................. 79

Appendix A. Rule Provision Comparison	89

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List of Tables

Table 3-1. Summary of section 401 certification fees	14

Table 3-2. State-reported length of time to issue a certification decision	15

Table 3-3. Time for the public comment period	17

Table 3-4. Summary Results of the Certification Decision Type Extraction Effort	Error! Bookmark not

defined.

Table 3-5. Summary statistics of timeframe determinations for section 401 certifications	Error!

Bookmark not defined.

Table 3-6. Summary statistics of timeframe determinations for section 401 certifications, with manual

corrections from targeted QA	Error! Bookmark not defined.

Table 3-7: License and permit summary data by certifying authority	24

Table 4-1. Summary of potential effects of the final rule, relative to the 1971 Rule and 2020 Rule

baselines	62

Table 6-1. Limitations and uncertainties in estimating effects of final rule	67

Appendix Tables

Table A-l. Full Results of the Certification Decision Type Extraction Effort.. Error! Bookmark not defined.
Table B-l. Comparison of rule provisions under the 1971 Rule, the 2020 Rule, and the final rule	89

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List of Figures

Figure 4-1. Incremental benefits of the final rulemaking


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Abbreviations

BLM

Bureau of Land Management

CA

Certifying Authority

CFR

Code of Federal Regulations

Corps

U.S. Army Corps of Engineers

CWA

Clean Water Act

DWR

Division of Water Resources

EJ

Environmental Justice

EO

Executive Order

EPA

U.S. Environmental Protection Agency

FERC

Federal Energy Regulatory Commission

ICR

Information Collection Request

NPDES

National Pollutant Discharge Elimination System

NRC

Nuclear Regulatory Commission

NTTAA

National Technology Transfer and Advancement Act

NWP

Nationwide Permit

PP

Project Proponent

RFA

Regulatory Flexibility Act

RHA

Rivers and Harbors Act

SBREFA

Small Business Regulatory Enforcement Fairness Act

TAS

Treatment in a Similar Manner as a State

TDEC

Tennessee Department of Environment and Conservation

UMRA

Unfunded Mandate Reform Act

USDA

U.S. Department of Agriculture

WDEQ

Wyoming Department of Environmental Quality

WOTUS

Waters of the United States

WQS

Water Quality Standards


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1 Executive Summary

The U.S. Environmental Protection Agency (EPA) is finalizing revisions to the Clean Water Act (CWA)
section 401 regulations to restore cooperative federalism principles and ensure that states and Tribes
are empowered to protect water resources that are essential to public health, ecosystems, and
economic opportunity. CWA section 401 provides states1 and authorized Tribes2 with the authority to
protect the quality of their waters from adverse impacts resulting from federally licensed or permitted
projects. Under 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 States3 unless the state or authorized Tribe
where the discharge would originate either issues a CWA section 401 water quality certification or
waives certification. 33 U.S.C. 1341(a)(1).

Pursuant to Executive Orders 12866 (Regulatory Planning and Review) and 14094 (Modernizing
Regulatory Review), EPA has prepared this economic analysis to inform the public of potential effects
associated with this rulemaking. This analysis is not required by the CWA.

This economic analysis assesses the potential impacts of the final CWA section 401 Water Quality
Certification Improvement Rule. Pursuant to President Biden's EO 13990 "Protecting Public Health and
the Environment and Restoring Science to Tackle the Climate Crisis," EPA reviewed the 2020 CWA
section 401 rule.4 In the spring of 2021, EPA determined that it would propose revisions to the 2020
Rule through a new rulemaking effort (U.S. EPA, 2021a). Due to ongoing litigation on the 2020 Rule, EPA
considers two baselines in this economic analysis for the final rule: (1) a 1971 Rule baseline, and (2) a
2020 Rule baseline. In this economic analysis, EPA describes the final regulatory changes and evaluates
the impacts to states, Tribes, and Federal agencies relative to the 1971 Rule and 2020 Rule baselines and
implementation practices. Since the 2020 Rule was in effect before this final rule, the 2020 Rule should
be considered the primary baseline, while the 1971 Rule is presented as an alternative baseline both for
information purposes and because of the regulatory uncertainty surrounding the 2020 Rule, which has
been challenged in Federal district court.

The final rule ensures that states and Tribes are empowered to protect water resources by clarifying key
components of the water quality certification process and improving coordination among Federal
agencies, certifying authorities, and project proponents. The economic impacts of the final rule are
expected to be minimal, as it codifies many existing practices that have been widely implemented over
the last 50 years or more and adds further clarity on several key issues. Key changes in the final rule that
are intended to restore cooperative federalism, empower certifying authorities to protect their water
resources, and improve Tribal rights/opportunities include: 1) an interpretation of the scope of a section

1	The 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).

2	The 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).

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

4	Clean Water Act section 401 Certification Rule, 85 FR 42210 (July 13, 2020) (hereinafter, the 2020 Rule). For
further discussion on the 2020 Rule, including legal challenges, please see Preamble Section IV.B.

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401 certification as encompassing the "activity," which allows certifying authorities to protect their
waters from the widest range of adverse water quality-related impacts; 2) a collaborative approach for
Federal agencies and certifying authorities to jointly set the reasonable period of time to act on a
request for certification; and 3) options for Tribes to apply for "treatment in a similar manner as a state"
(TAS) status and participate in CWA section 401(a)(2), neighboring jurisdiction determinations.

The Agency anticipates that the final rule will result in more predictable, efficient decision-making by
certifying authorities relative to the two baselines. Although the final rule may impose some burdens on
certifying authorities (e.g., reasonable period of time negotiations) and project proponents (e.g., pre-
filing meeting requests), the Agency expects that clear, unambiguous procedural requirements will
improve section 401 procedural efficiencies for both certifying authorities and project proponents. The
final rule clarifies ambiguities in the section 401 process, including scope, modifications,5 neighboring
jurisdictions assessments, and procedures that would apply when EPA acts as the certifying authority.
These revisions will help standardize the certification process, reduce confusion, and promote efficient
section 401 reviews. The final rule also creates a means for Tribes to obtain TAS for section 401 and/or
section 401(a)(2) directly, which will limit costs for Tribes interested in obtaining TAS for section 401
and/or section 401(a)(2) that do not want to administer the section 303(c) program for water quality
standards (WQS).

Although both baselines include the requirement that the Federal agency notify EPA upon receipt of an
application for a Federal license or permit and a certification, the Agency has historically only received
copies of the application and certification when EPA is the permitting Federal agency or is acting as the
certifying authority. Thus, the Agency does not have comprehensive data to estimate the number of
certification decisions (grant, grant with conditions, deny, or waive) per year, nor does the Agency have
data to suggest how these decisions will change under the final rule. The lack of a national-level dataset
on section 401 certification reviews limited EPA's ability to perform a quantitative analysis of the
incremental impacts of the final rule. Thus, EPA qualitatively assessed potential impacts of the final rule.
The qualitative analysis consisted of characterizing baseline conditions and identifying impacts of the
regulatory changes based on information shared in pre-proposal input letters and public comments.

2 Introduction

Under Clean Water Act (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 (WOTUS) unless
the certifying authority where the discharge would originate either certifies that the discharge will
comply with applicable water quality requirements or waives certification. The certifying authority is
determined based on the location where the discharge originates (or may originate) and can be a state,
territory, authorized Tribe, and in some circumstances, EPA. Certifying authority under CWA section 401
can be assumed by Indian Tribes under section 518 of the CWA, which authorizes EPA to treat eligible
Tribes with reservations in a similar manner to states (referred to as "treatment in a similar manner as a
state" or TAS).6 EPA is responsible for section 401 certification decisions in instances when a state or

5	Certifying authorities and Federal agencies may agree to modify a grant of certification (with or without
conditions). However, only the agreed upon portions may be modified.

6	33 U.S.C. 1377(e).

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Tribal government lacks certification authority [e.g., on Tribal lands where Tribal governments do not
have TAS and on lands with exclusive Federal jurisdiction in relevant respects). As the Federal agency
charged with implementing the CWA, as well as the certifying authority in certain instances, EPA is
responsible for developing regulations and guidance to ensure effective implementation of all CWA
programs, including section 401.7

Congress enacted the Federal Water Pollution Control Act in 1948, but the law took on its modern form
in 1972 in the Federal Water Pollution Control Act Amendments of 1972 (Clean Water Act). EPA
promulgated regulations for water quality certification in May 1971. These regulations pre-date the
passage of the 1972 CWA amendments and were based on CWA section 401's predecessor, section
21(b) of the Water Quality Improvement Act of 1970.8 An April 2019 Executive Order (EO 13868)
directed EPA to promulgate a new rule to clarify and modernize the Agency's 1971 Rule, and in 2020,
EPA revised these regulations (U.S. EPA, 2020). On January 20, 2021, President Biden signed EO 13990
"Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis"
directing Federal agencies to review rules issued in the prior four years that are, or may be, inconsistent
with the policy goals of the new Administration.

Pursuant to President Biden's EO 13990, EPA reviewed the 2020 Rule. In the spring of 2021, EPA
determined that it would propose revisions to the 2020 Rule through a new rulemaking effort (U.S. EPA,
2021a). The Agency identified substantial concerns about whether portions of the 2020 Rule impinged
on the cooperative federalism principles central to CWA section 401. As a result, the Agency announced
its intention to revise the 2020 Rule in a manner that is well-informed by stakeholder input, better
aligned with the cooperative federalism principles that have been central to the effective
implementation of the CWA, and responsive to the national objectives outlined in EO 13990.

EPA is finalizing revisions to the 2020 Rule consistent with the principles outlined in EO 13990 and the
Agency's legal authority. Additionally, EPA is revising the 2020 Rule in a manner that promotes efficiency
and certainty in the certification process, that is well-informed by stakeholder input on the section 401
certification rule's substantive and procedural components, and that is consistent with the cooperative
federalism principles central to CWA section 401. The final rule also includes conforming revisions to the
water quality certification regulations for EPA-issued National Pollutant Discharge Elimination Systems
(NPDES) permits to align with the final section 401 Rule.

To support the final rule, EPA has prepared this economic analysis and other related rule analyses to
assess potential impacts of the rule. These analyses seek to evaluate the benefits and costs of the final
rule and the effects of the rule on vulnerable groups and small entities. Section 3 of this economic
analysis presents an overview of the practice under the 1971 Rule and 2020 Rule (two baselines),
including a summary of Federal licenses and permits that require section 401 certification. Section 4
summarizes each provision and presents a qualitative assessment of the potential impacts of the final
rule on project proponents, certifying authorities, and Federal agencies when transitioning from the two
baselines to the new rule requirements. Section 5 presents an environmental justice analysis
characterizing potential impacts of the final rule on communities with environmental justice concerns.

7	33 U.S.C. 1251(d), 1361(a).

8	Water Quality Improvement Act of 1970, P.L 91-224, 84 Stat. 91 (April 3,1970).

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Section 6 presents data limitations and uncertainties. Section 7 discusses consideration of statutory and
Executive Order requirements.

3 Baseline Conditions

The baseline is a description of the world absent the final regulation and is the starting point for
determining the potential benefits and costs of a final regulation. Due to ongoing litigation on the 2020
Rule, EPA is considering two baselines in this economic analysis. The primary baseline is the 2020 Rule
that was in effect before this final rule, and the alternative baseline is the 1971 Rule with the regulations
and practices that were in effect and occurred from 1971 through 2019.9

The CWA section 401 certification process provides an important tool for certifying authorities to
protect their water quality from potential effects caused by the "activity" and discharges from federally
licensed or permitted projects. A Federal agency may not issue a license or permit to conduct any
activity that may result in any discharge into a WOTUS unless the certifying authority where the
discharge originates or would originate either issues a section 401 water quality certification verifying
compliance with CWA sections 301, 302, 303, 306, and 307, and any other appropriate requirement of
state or Tribal law, or waives certification.

Section 401 certification is required for various Federal licenses and permits including, but not limited
to, dredge and fill activities that require CWA section 404 permits from the U.S. Army Corps of Engineers
(Corps), CWA section 402 NPDES permits for industrial and municipal point source discharges issued by
EPA, permits issued under sections 9 and 10 of the Rivers and Harbors Act (RHA) by the Corps (or the
U.S. Coast Guard for bridges and causeways under section 9), mining plan of operations approvals issued
by the Department of the Interior's Bureau of Land Management (BLM) and the U.S. Department of
Agriculture's (USDA) Forest Service, projects requiring licenses from the Federal Energy Regulatory
Commission (FERC) or the Nuclear Regulatory Commission (NRC), shoreline permits issued by the
Tennessee Valley Authority, and permits for alcohol producers and manufacturers issued by the Alcohol
and Tobacco Tax and Trade Bureau. Additional Federal licenses and permits are subject to section 401 if
they authorize any activity that may result in a discharge from a point source into a WOTUS.

3.1 Description of Certifying Authority Determinations

A certifying authority may take four potential actions pursuant to its section 401 authority: grant, grant
with conditions, deny, or expressly waive certification. If a certifying authority fails or refuses to act on a
request for certification within the reasonable period of time, it will constructively waive certification.
Though both baselines include the requirement that the Federal agency notify EPA upon receipt of an
application for a Federal license or permit and a certification, the Agency has historically only received
copies of the application and certification when EPA is the Federal permitting agency or is acting as the
certifying authority. Thus, the Agency does not have comprehensive data on the number of certification
decisions (grant, grant with conditions, deny, or waive) over time and therefore does not have available
data to quantify the number of actions that fall into each of these categories.10

9	Continuing to include both baselines also better facilitates comparison of the economic analyses at the proposal
and final rule stages.

10	See Section 3.2.5 below for discussion of an effort, via machine reading, to cull data from certification
documents that states make available on their websites.

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Under the two baselines, certifying authorities generally determined whether the federally licensed or
permitted activity (1971 Rule) or discharge (2020 Rule) will comply with the listed CWA provisions and
other appropriate requirements of state or Tribal law. Regarding the determinations certifying
authorities may make, there are differences between the scope of review across the 1971 Rule, 2020
Rule, and the final rule that are further discussed in section 4.5 in this economic analysis.

Under the two baselines, certifying authorities make determinations as follows:

1)	Grant certification. Under the 1971 Rule, certifying authorities may grant section 401
certification if they determine that the proposed activity will comply with water quality
requirements. Under the 2020 Rule, certifying authorities may grant section 401 certification if
they determine that the proposed discharge will comply with water quality requirements. When
certification is granted by a certifying authority to a project proponent for a Federal license or
permit under either rule, the Federal licensing or permitting agency (hereafter, the "Federal
agency") may issue the license or permit.

2)	Grant certification with conditions. Under the 1971 Rule, certifying authorities impose
limitations or conditions in their section 401 certifications as necessary to ensure the activity will
comply with water quality requirements. Under the 2020 Rule, certifying authorities impose
limitations or conditions in their section 401 certifications as necessary to ensure the discharge
will comply with water quality requirements. Section 401(d) requires the Federal agency to
include all the certifying authority's conditions as part of the resulting license or permit.11 When
a certification is granted with conditions under either rule, the Federal agency may issue the
license or permit, and any certification conditions included in the section 401 certification
become part of the Federal license or permit.

3)	Deny certification. Under the 1971 Rule, certifying authorities may deny section 401
certification if they cannot certify that the activity will comply with water quality requirements.
Under the 2020 Rule, certifying authorities may deny section 401 certification if they cannot
certify that the discharge will comply with water quality requirements. Under either rule, a
certification denial prohibits the Federal agency from issuing the license or permit.

4)	Waive review. Certifying authorities may waive section 401 certification, either expressly
through notification to the project proponent or constructively by failing or refusing to act on
the certification request within the reasonable period of time. The statute states that if a
certifying authority fails or refuses to act on a certification request within the reasonable period
of time, the certification requirement shall be waived (33 U.S.C. 1341(a)(1)). Under the 2020
Rule, a certifying authority may also fail or refuse to act where the certifying authority's action
on a request for certification is procedurally deficient (e.g., does not follow the 2020 Rule's
procedural requirements for a denial of certification). 40 CFR 121.9(a)(2) (2020). A waiver does
not necessarily indicate a certifying authority's opinion regarding the potential water quality
implications of an activity since a certifying authority may waive certification for a variety of

11 33 U.S.C. 1341(d) (requiring "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 applicable requirement of State law ... shall become a condition on any Federal license or
permit...

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reasons, including a lack of resources to evaluate the request. Under both rules, when certifying
authorities waive certification, the Federal agency may issue the license or permit without a
certification from the certifying authority.

3.2 Information from Certifying Authorities

To support this rulemaking effort, EPA investigated the possibility of generating comprehensive data on
the section 401 process from the certifying authority perspective. EPA reviewed state and territory
websites to investigate data availability and assemble available quantitative data. EPA also conducted a
focused review of pre-proposal input letters12 and comment letters13 to extract any information
concerning the number of requests for certifications and decisions (Section 3.2.1), certification
processing fees (Section 3.2.2), the time to issue a certification decision (Section 3.2.3), and the time
required for the public comment process (Section 3.2.4). This section summarizes results from website,
pre-proposal input, and public comment reviews. EPA used results from the review of certifying
authority websites, pre-proposal input, and public comments in the baselines to describe the available
data on certification decisions, section 401 fees, and the time it takes for certifying authorities to act on
certification requests.

EPA found that only five certifying authority websites14 have readily usable public documentation of
their annual average number of section 401 certification decisions for the purposes of creating a more
robust characterization of certification decisions. EPA determined that seven additional certifying
authorities have section 401 certification data publicly available in PDF format: Arkansas (AR DEQ, 2022),
California Water Board of San Diego (California Water Board of San Diego, 2021), Idaho (ID DEQ, 2022),
Mississippi (MS DEQ, 2022b), New Hampshire (NH DES, 2022), Oregon (OR DEQ, 2022), and Washington
(WSDE, 2022). EPA investigated methods to extract data from PDFsforthe purposes of further
characterizing the available information on certification decisions (Section 3.2.5 below).

The available data are not sufficient for developing a nationally representative dataset for the annual
average number of section 401 reviews conducted, the proportion of section 401 certification requests
that are waived, or the proportion of reviews that result in certifications granted without conditions,
certifications granted with conditions, or denials of certification. See Section 3.2.5 below for more
information on this machine reading effort.

3.2.1 Quantitative Data on the Number of Section 401 Certification Requests and Decisions
Certifying authorities for some states provided information about the average number of section 401
certification requests reviewed each year. Among these states, Michigan, New York, and Tennessee
review the most certification requests on an annual basis with Michigan reviewing an average of 4,000
certification requests, New York reviewing an average of 4,000 certification requests, and Tennessee
reviewing between 3,610 to 4,000 general and 458 to 490 individual permit certification requests.15

12	Docket ID No. EPA-HQ-OW-2021-0302.

13	Docket ID No. EPA-HQ-OW-2022-0128.

14	States with readily usable section 401 certification data: Connecticut (CT DEEP, 2021), Delaware (DE NREC, n.d.),
Idaho (ID DEQ, 2021), Missouri (MO DNR, n.d.), and Oregon (OR DEQ, n.d.-a).

15	Earthjustice (EPA-HQ-OW-2022-0128-0269). Basil Seggos, Commissioner of New York State Department of
Environmental Conservation (0042). Note that this letter was submitted prior to the 2020 Rule in response to the
2019 proposed rule. Tennessee Department of Environment and Conservation (EPA-HQ-OW-2021-0302-0083).
Tennessee Department of Environment and Conservation (EPA-HQ-QW-2022-0128-0180).

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North Carolina and Washington stated that they review over 1,600 and 400 certification requests
annually, respectively.16 In contrast, Colorado and Utah review far fewer certification requests, as
Colorado reviews only 14 annually since 2015, while Utah receives approximately 16 requests each
year.17 The Texas Railroad Commission also receives a small number of certification requests, between
10 and 20 annually, though the Texas Commission on Environmental Quality processes the majority of
certification requests.18

EPA extracted limited quantitative information provided in pre-proposal input letters on the number of
section 401 certifications granted by certifying authorities. Data limitations prevented a quantitative
assessment of the final rule's impact on the number of certification grants. Certifying authorities for six
states provided information about the number of section 401 certifications granted (with or without
conditions) each year or over a specified period of time. Of the six states, the New York Department of
Environmental Conservation and the California Water Boards issue the most certifications annually at
approximately 4,050 certifications and over 1,000 certifications, respectively.19 Additionally, the New
Mexico Environmental Department stated that they issued over 1,000 certifications from 2017 to 2019,
including 46 Federal CWA section 402 permits.20 On the lower end of the spectrum, the Pennsylvania
Department of Environmental Protection and the Washington Department of Ecology stated that they
issue 350-500 and 400 certifications annually, respectively.21 Lastly, two states provided information on
certifications related to FERC licenses and licenses for other uses of water. Wisconsin stated that they
certified 41 FERC-regulated dams over the past 30 years.22 Between 2018 and 2021, the California
Division of Water Rights stated that they issued 29 certifications, including amendments, related to FERC
licenses and other Federal permits or licenses for the diversion or use of water.23

Certifying authorities for three states provided information about the number of section 401
certification denials. New York stated that they denied an average of eight certification requests per
year prior to 2020.24 Oregon stated that they denied a total of either five or eleven certification requests

16	North Carolina Department of Environmental Quality (0124) and various attorneys general (0098) Part 2; State of
Washington Department of Ecology (EPA-HQ-OW-2021-0302-0025).

17	Various attorneys general (EPA-HQ-OW-2021-0302-0098) attachment D Part 1. Utah Department of
Environmental Quality (EPA-HQ-OW-2022-0128-0158).

18	EIP (EPA-HQ-OW-2022-0128-0127).

19	Various attorneys general (EPA-HQ-OW-2021-0302-0098) attachment D Part 3; Various attorneys general (EPA-
HQ-OW-2021-0302-0098) attachment D Part 1.

20	Various attorneys general (EPA-HQ-OW-2021-0302-0098) attachment D Part 2.

21	Pennsylvania Department of Environmental Protection (EPA-HQ-OW-2021-0302-0052); Various attorneys
general (EPA-HQ-OW-2021-0302-0098) attachment D Part 1. In 2020, the section 401 workload tripled for the
Washington Department of Ecology; by August 26, the department had already issued 396 certifications. The
reason for the increase in section 401 certification is because "the invalidation of the nationwide aquaculture
permits resulted in a flood of individual section 401 certification requests for shellfish growing operations."

22	Wisconsin Department of Natural Resources (EPA-HQ-OW-2021-0302-0038).

23	Various attorneys general (EPA-HQ-OW-2021-0302-0098) attachment D Part 1.

24	Basil Seggos, Commissioner of New York State Department of Environmental Conservation (EPA-HQ-OW-2021-
0302-0042). Note that this letter was submitted prior to the 2020 Rule in response to the 2019 proposed rule.

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from 1999 to 2020.25 Lastly, Wisconsin stated that they had not denied a certification request for FERC-
regulated dams in over 30 years.26

Wisconsin is the only certifying agency that shared waiver information in its pre-proposal letter. The
Wisconsin Department of Natural Resources waived section 401 review for 43 FERC-regulated dams
over the past 30 years.27

3.2.2 Certification Processing Fees

Table 3-1 summarizes the various fees associated with the section 401 certification process that are
available on state/territory websites. Twenty-eight states/territories list a section 401 fee, often
increasing as the complexity or size of the project increases. Twelve states/territories explicitly state
that they do not charge a section 401 fee,28 while 16 states/territories do not include any fee
information on their website.29 In some cases, it is unclear if the reported fee is solely for section 401
certification or if it incorporates fees for other state permitting processes. Approximately 77% of fees
have a maximum range between $385-$5,000. The average cost for states/territories with a flat fee
instead of a range is $277. Reported fees that significantly exceed this range may incorporate fees for
other state permitting processes (i.e., joint permit fees).

Table 3-1. Summary of section 401 certification fees

State / Territory

Section 401 Fee

Source

Alabama3

$800 - $25,920

ALDEM (2021)

Alaska

$320-$2,375

AK DEC (2020)

California3

$645 - $2,417

CA Water Boards (2022)

Colorado3

$1,122 - $3,876

CO DPHE (2022)

Florida

$100-$14,020

FL DEP (2011)

Hawaii

$0 - $1,000

HA DHCWB (2013)

Illinois3

$350

IL EPA (2022a)

Kentucky

$1,000 - $5,000

KY LRC (n.d.)

Louisiana

$37 - $385

LA DEQ (n.d.)

Maine3

$263-$1,881

ME DEP (2021)

Maryland

$385

MD DE (2022)

Massachusetts3

$90 - $490

CMR (2021)

Missouri

$150-$1,500

MO COR (2020)

25	Oregon Department of Environmental Quality (EPA-HQ-OW-2021-0302-0045); Various attorneys general (EPA-
HQ-OW-2021-0302-0098) attachment D Part 3. The number of denials reported in the attorneys general pre-
proposal letter conflicts with the number reported in the Oregon Department of Environmental Quality pre-
proposal letter; it is unclear which source is more accurate, thus EPA presents the range covering both sources.

26	Wisconsin Department of Natural Resources (EPA-HQ-OW-2021-0302-0038).

27	Wisconsin Department of Natural Resources (EPA-HQ-OW-2021-0302-0038).

28	Twelve states/territories that do not charge a fee: Arizona (AZ DEQ, 2021a), Indiana (IN DEM, 2022a), Kansas (KS
DHE, 2022), Minnesota (MN PCA, n.d.), Mississippi (MS DEQ, 2022a), Nebraska (NE DEE, 2021), New Hampshire
(NH DES, 2022), New Mexico (NM ED, 2021a), North Dakota (ND DEQ, 2022), Pennsylvania (PA DEP, 2022), South
Dakota (SD DANR, 2020), and Wyoming (WY DEQ, n.d.).

29	Sixteen states/territories had no information available about section 401 certification fees on their websites:
Arkansas (AR DEQ, n.d.), Connecticut (CT DEEP, 2021), Delaware (DE NREC, n.d.), District of Columbia (DC DOEE,
n.d.), Georgia (ASWM, 2011c), Idaho (ID DEQ, 2021), Iowa (IA DNR, n.d.), Michigan (Ml DEGLE, 2022), Nevada (NV
DEP, n.d.), New York (NYS DEC, n.d.), Texas (TX CEQ, 2021), Washington (WSDE, n.d.), Puerto Rico (U.S. EPA, 2005),
Guam (GU EPA, 2022), American Samoa (AS EPA, 2022), and the Virgin Islands (VI DPNR, 2019).

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Table 3-1. Summary of section 401 certification fees

State / Territory

Section 401 Fee

Source

Montana

$400 - $20,000

ARM (n.d.)

New Jersey3

$0 - $5,000

NJ DEP (2019)

Northern Mariana Islands3

$100-$ 5,000

MP Administrative Code (2018)

North Carolina

$240 - $570

NC DEQ (n.d.)

Ohio3

$200

OH EPA (n.d.)

Oklahoma

$100

OK DEQ (2022)

Oregon

$985 - $14,020

Oregon State Archives (2022)

Rhode Island

$200 - $400

Rl DEM (2005)

South Carolina

$100-$1000

ASWM (2011a)

Tennessee

$0 - $5,000

TN DEC (n.d.)

Utah

$100/hour

UT DEQ (2022)

Vermont

$200 - $20,000

VT DEC (2020)

Virginia

$0 or direct cost of WQC services

VA DEQ (n.d.)

West Virginia

$350

WV DEP (n.d.)

Wisconsin3

$50 -$2,000

ASWM (2011b)

a. Fee(s) may be subject to additional stipulations, such as conditional processing fees, project type variations, expedition fees, project fees,
annual fees, among others.

3.2.3 Time to Issue a Certification Decision

Fourteen states provide readily usable information—on their websites, in pre-proposal input letters, or
in public comments—about the length of time to issue a certification decision. Most states issue
certification decisions within 60-90 days. The North Carolina Department of Environmental Quality
stated that over 90% of their applications between July 1, 2015, and June 30, 2017 (approximately 2,250
applications) were issued in under 60 days. Moreover, only 32 applications took over six months to
certify and most of that time (over four months) was spent waiting on the applicant to provide
additional information. Certification decisions for these applications were issued on average within 21
days after receipt of complete information.30 The information provided by states on the length of time
to issue a certification decision is summarized in Table 3-2 below.

EPA also used machine reading techniques to extract information about time to issue a certification
from certification decision documents. See Section 3.2.5.2 below for a summary of the methodology and
findings from this effort.

Table 3-2. State-reported length of time to issue a certification decision

State/Territory

Number of Days

Source

Alaska

60

AK Department of Environmental
Conservation (EPA-HQ-OW-2021-0302-0065)

Arkansas3

93

AR DEQ (2022)

Colorado15

60 (majority of projects); 365 (for large
projects)

Colorado Department of Public Health and
Environment (EPA-HQ-OW-2022-0128-0322);
(EPA-HQ-OW-2021-0302-0057)

Connecticut

< 180

CT DEEP (2021)

Delaware0

60-90

DE NREC (n.d.)

Idaho

60

ID DEQ (2021)

Missouri

60

MO DNR (n.d.)

30 North Carolina Department of Environmental Quality (EPA-HQ-OW-2021-0302-0124).

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Table 3-2. State-reported length of time to issue a certification decision

State/Territory

Number of Days

Source

North Carolina

60

NC Department of Environmental Quality
(EPA-HQ-OW-2021-0302-0124)

Oregon6

45; 60-180; 210-365

OR DEQ (n.d.-a)

Tennessee'

85 (individual permits); 6 (general permits)

TN Department of Environment and
Conservation (EPA-HQ-OW-2021-0302-0083)

Utah

80

UT Department of Environmental Quality
(E PA-HQ-OW-2021-0302-0028)

Virginia

120

Sothern Environmental Law Center (EPA-HQ-
OW-2022-0128-0118)

Washington8

"several months" (seasonally dependent)

WA State Department of Ecology (EPA-HQ-
OW-2021-0302-0025)

Wyoming

60

WY Department of Environmental Quality
(EPA-HQ-QW-2021-0302-0019)

a.	Uses certification decision information from 2013 to the effective date of the 2020 Rule. 188 of 374 certifications did not contain enough
information to calculate the issuance timeframe [i.e., request and issuance dates). Based on the 186 section 401 certification decisions which
contained this information, the average issuance timeframe was 93 days.

b.	The Colorado Department of Public Health and Environment (CDPHE) stated that the full one-year time period was needed to complete
section 401 review for large projects such as the last four water supply projects in the state.31

c.	For certifications that require public notice.

d.	For certification of section 404 permits.

e.	The estimated timeframe depends on the complexity of the project, the quality of the information provided, significance of water quality
concerns raised during the public commenting process, and the responsiveness of the applicant.

f.	The numbers provided in the table are from the receipt of complete opplicotions. The Tennessee Department of Environment and
Conservation (TDEC) stated that the average processing time for individual and general permits is 205 and 34 days from the initial certification
requests given that they often lack sufficient information to analyze water quality impacts and solicit public input.32

g.	The Washington State Department of Ecology (WSDE) stated that the necessary time to complete a section 401 review is often influenced by
the time of year (for example, wetland delineation work typically cannot be adequately completed during the dry summer months).33

3.2.4 Time Required for the Public Comment Process

State public notice periods for section 401 certifications range from 14 to 90 days, with 30 days as the
most common timeframe. Certifying authorities for four states (New Hampshire, Rhode Island,
Maryland, and Minnesota) described how a 60-day reasonable period of time was inadequate for
completing the public comment process, which includes the time needed for comments to be received,
to review and address comments, and/or to hold public hearings.34 For example, the New Hampshire
Department of Environmental Services and the Rhode Island Department of Environmental
Management stated that they allow for a 30-day comment period and that additional time is needed to
review and respond to these comments. The same two certifying authorities suggested that the
minimum amount of time for section 401 certifications should be 120 days.35 In their pre-proposal input

31	Colorado Department of Public Health and Environment (EPA-HQ-OW-2021-0302-0057).

32	Tennessee Department of Environment and Conservation (EPA-HQ-OW-2021-0302-0083).

33	Washington State Department of Ecology (EPA-HQ-OW-2021-0302-0025).

34	New Hampshire Department of Environmental Services (EPA-HQ-OW-2021-0302-0039); Rhode Island
Department of Environmental Management (EPA-HQ-OW-2021-0302-0126); Maryland Department of the
Environment (EPA-HQ-OW-2021-0302-0069); Minnesota Pollution Control Agency (EPA-HQ-OW-2021-0302-0047).

35	New Hampshire Department of Environmental Services (EPA-HQ-OW-2021-0302-0039); Rhode Island
Department of Environmental Management (EPA-HQ-OW-2021-0302-0126).

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letters, Maryland and Minnesota did not describe their minimum public notice period. Table 3-3
summarizes states' public notice periods.

Table 3-3. Time for the public comment period

State / Territory

Public Notice Period (days)

Source

Alaska

30

AK DEC (2022)

Arizona

30

AZ DEQ (2021b)

California

21

California Water Board of San Diego (2021)

Colorado

30

Code of Colorado Regulations (2019)

Delaware

20

DE NREC (n.d.)

Hawaii

30

HA DHCWB (2022)

Idaho

21

ID DEQ (2021)

Illinois

14

IL EPA (2022b)

Indiana

30

IN DEM (2022b)

Kansas

21

KS DHE (2022)

Kentucky

30

KY EEC (2019)

Massachusetts

21

CMR (2014)

Minnesota3

Case-by-case; 10-day minimum

MN ORS (2009)

Missouri

21

MO DNR (n.d.)

New Hampshire

30

NH DES (2022)

New Mexico

30

NM ED (2021b)

North Carolina

30

NC AC (2019)

Ohiob

30-45

OH EPA (2006)

Oklahoma

30

OK DEQ (2022)

Oregon

30-35

OR DEQ (n.d.-b)

Rhode Island

30

Rl Department of Environmental
Management (EPA-HQ-OW-2021-0302-0126)

Tennessee15

30-90

TN DEC (n.d.)

Utah

30

Utah DEQ (EPA-HQ-OW-2022-0128-0158)

Vermont

30

VT DEC (2022)

a.	Public comment period established by the commissioner on a case-by-case basis based on the scope, nature, and potential
impacts on water quality of the project; public notice period cannot be shorter than ten days.

b.	The public notice period increases to 45 days (Ohio) or 90 days (Tennessee) if a hearing is requested.

3.2.5 Certification Decision PDF Extraction Effort

Certifying authorities can act on requests for certifications in one of four ways: 1) grant certification, 2)
grant certification with conditions, 3) deny certification, or 4) waive certification either expressly or
constructively by failing to act on a request for certification within the reasonable period of time. To
better understand certification decisions and the timing of the certification process, EPA searched for
data on certification decisions. EPA found seven certifying authorities (Arkansas, California Water Board
of San Diego, Idaho, Mississippi, New Hampshire, Oregon, and Washington) that make their certification
decision documents publicly available online.

EPA took a machine reading approach and developed code using R, a statistical analysis software36, to
extract information from certification decision documents. The objective of this machine reading

36 See the Certification Decision PDF Extraction Memo for further discussion about the specific software and
package versions used for the certification decision type machine reading model and the time to issue the
certification decision machine reading model.

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exercise was to gather data on 1) the distribution of certification decision types (see Section 3.2.5.1
below) and 2) the length of time it takes for certifying authorities to act on a request for certification
(see Section 3.2.5.2 below). EPA downloaded and organized certification decisions from the seven state
certifying authority websites. When developing the download methodology, EPA aimed to prioritize
recent certification decisions and include as many states as available. Some states (e.g., Arkansas,
California Water Board of San Diego, Idaho) had multiple years of certification decision documents
available, while other states (e.g., New Hampshire, Washington) had only the most recent certification
decision documents posted. In total, EPA extracted a random sample of 200 certification decisions
across the seven certifying authorities.37 For details about the methodology for downloading section 401
certification decisions from state websites, see Clean Water Act Section 401 Water Quality Certification
Improvement Rule - Final Rule, Memorandum to the File, Certification Decision PDF Extraction Effort
("Certification Decision PDF Extraction Memo"), available in Docket ID No. EPA-HQ-OW-2022-0128. The
Agency then conducted a preliminary data review of the certification decision documents to determine
whether they could be used for machine reading analysis and/or whether they were properly classified
as certification decision documents. Eighteen files were removed prior to the machine reading analysis
due to their classification as non-certification decision documents (e.g., modifications), duplicates, or
non-machine-readable files. For more information on these specific files, please see Section 1.2 of the
Certification Decision PDF Extraction Memo. Ultimately, the Agency used machine reading analysis on
183 certification decision documents; further discussion on the analysis is included below.

Overall, the machine reading effort did not generate data of a quality sufficient to pass EPA's quality
assurance standards.38 Section 401 and prior regulatory regimes do not prescribe the exact structure,
format, or language that must be included in all certification decisions (e.g., how to communicate the
nature of a certification decision). As a result, each state has developed its own structure, format, and
language for certification decision documents. Although EPA developed code intended to capture
variations in document structures, language usage, and date formats, the heterogenous nature of the
certification decisions limited the practicality of using machine reading to extract information on the
nature of the certification decision and the time to act on a request for certification. For example,
certain formats may have caused the code to generate interpretation errors (e.g., various date formats)
or miss relevant information (e.g., the certifying authority uses different phrases than the target words).

Sampling limitations made it difficult to derive information that could provide nationally representative
information for several reasons. First, section 401 does not require certifying authorities to make
certification decision documents readily accessible. As a result, the findings from these extraction efforts
are based on certification decisions from only seven states (i.e., the states that post their certification
decisions on their websites). Second, due to the broad applicability of section 401 (e.g., all Federal

37	EPA downloaded 40 certification decision documents from Arkansas, 41 from California Water Board of San
Diego, 23 from Idaho, 39 from Mississippi, four from New Hampshire, 13 from Oregon, and 40 from Washington.
The files included 201 PDFs because one certification decision from Oregon had two separate PDFs, a certification
letter and a certification conditions document, that could not be combined into one file. These documents
included a total of 2,680 pages, that would have taken considerable labor hours to read and record information, if
done manually.

38	See Certification Decision PDF Extraction Memo for further discussion on the limitations associated with machine
reading models and the manual review efforts.

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licenses or permits that may result in a discharge into waters of the United States), the certification
decisions span multiple license or permit types, project sizes, and complexities. Lastly, fluctuations in
applicable section 401 regulations and the different information requirements for a certification
decision, particularly over the last three years, may have introduced further variation in certification
decision documents.

Given these limitations, EPA determined that results of the machine reading effort were subject to
significant limitations and did not attempt to expand the analysis beyond the sample of 183 certification
decision documents.39 Nevertheless, this section provides further discussion of EPA's machine reading
efforts and outputs for informational purposes; because of the aforementioned data quality concerns,
the following information was not used to inform decision-making in this final rule.

3.2.5.1 Certifies tion Decision Types

The first extraction effort focused on determining the certification decision type (grant of certification,
grant of certification with conditions, waiver of certification, or denial of certification) of each
certification decision document. There were two components to this effort of gathering data on
certification decision types. First, EPA used machine reading to search and count specified keywords
associated with the types of certification decisions. Second, the Agency conducted a manual review of
the certification decision documents to both check the machine reading results and ascertain the
limitations of the machine reading model exercise.

3.2.5.1.1 Machine Reading

Using R, EPA developed machine reading code to find terms associated with certification decision types
in the certification documents (see Section 1.3.1 in Certification Decision PDF Extraction Memo). EPA
expected to find at least one of the terms associated with certification decision types in each document.
EPA combined phrase variations associated with each of the four decision types.40 As the model looped
through the PDFs, it counted the number of times each PDF used a keyword and grouped the count by
certification decision type.

From this model output, EPA calculated the number of certification decision documents that included
keywords for the four certification types and the percentage of documents for each decision type, which
are presented in Table 3-4. (Table 3-4 also includes summary results for EPA's manual review of the
certification decision documents discussed further below.) Approximately 97 percent of the 183 files run
through the machine reading model contained keywords related to a grant of certification with
conditions (i.e., "conditions" or "condition"). As anticipated based on other baseline information
presented in Section 3.2 above, the percentage of certification decisions, identified in the machine
reading exercise, with language about denials is small (approximately 11 percent). The actual
distribution of decision types is uncertain given that the sum of percentages across the Certify,

39	EPA considered conducting a machine learning effort but recognized that its results would likely still be of limited
use because so few authorities post all, if any, of their certification decisions online. EPA thus determined that
machine learning was beyond the scope of this analysis.

40	EPA developed a list of 16 specific words and phrases (certify, certifies, grant, grants, granting, approve,
approves, issues, waive, waives, waiver, deny, denies, denial, condition, and conditions). When the machine
reading code found any of the search terms, it also copied the term and surrounding text to an output file to
provide context regarding the usage of the word or phrase and help identify cases for which usage of the word or
phrase was unrelated to the certification decision type.

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Conditions, Deny, and Waive groupings exceeds 100 percent (due to certification decisions being
assigned to more than one decision type).

Table 3-4. Summary Results of the Certification Decision Type Extraction Effort

Machine Reading Model

Certify

Conditions

Deny

Waive

Number of certification decisions

182

178

21

57

Percentage

99%

97%

11%

31%

Manual Review

Certify

Conditions

Deny

Waive

Number of certification decisions

4

176

2

1

Percentage

2%

96%

1%

1%

3.2.5.1.2 Manual Review

As mentioned previously, EPA also conducted a manual review of certification decision documents as a
quality assurance and quality control exercise. The Agency mined the PDF files for keywords related to
certification decisions by reviewing each document using the Adobe Acrobat Pro search function for
"Whole Words Only" to identify a set of pre-determined keywords that relate to a certification decision.
The Agency used the same 16 keywords identified above for the machine reading analysis. The results of
this manual review (Table 3-4) confirm some general finding patterns from the machine reading results,
while also highlighting the limitations of the machine reading model. For example, the manual review
validated the machine reading finding that a significant percentage of the documents are related to
grants of certification with conditions. However, the manual review also shows that the results for the
Certify group from the machine reading is highly inflated (99% in machine reading versus 2% in manual
reading). This discrepancy is likely due to fact that the keywords selected for a "grant of certification"
could also be used in other certification decision related contexts or in contexts entirely unrelated to the
certification decision type, such as attestation statements. See the Certification Decision PDF Extraction
Memo for examples.

The manual review confirms the general finding that denials and waivers make up lower percentages of
the certification decisions, but with much smaller proportions in the manual review results (11% in
machine reading versus 1% in manual reading for denials of certification and 31% in machine reading
versus 1% in manual reading for waivers of certification). The differences and methods for the manual
review and machine reading efforts are further discussed in the Certification Decision PDF Extraction
Memo.

3.2.5.2 Time to Issue a Certifies tion Decision

The second extraction effort focused on dates available in certification documents, specifically the date
that the request for certification was received {i.e., when the certifying authority received the section
401 certification request), request for certification complete dates {i.e., when the certifying authority
deemed the section 401 certification request complete), and certification issuance dates {i.e., when the
certifying authority issued a decision). Similar to the certification decision type data extraction effort,
there is a machine reading component and a manual review component for gathering data on the timing
of certification decisions.

3.2.5.2.1 Machine Reading

Using R, EPA developed machine reading code that extracted multiple dates in the certification decision
documents to be used to calculate the time it takes to issue a certification decision (see Section 1.4.1 in

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Certification Decision PDF Extraction Memo). The model searched for and extracted dates41 that were
close in proximity to keywords related to application date, certification issued, application completed,
and submitted request. EPA included terms related to application completed and submitted request to
capture the different terminology that different certifying authorities may use in their decision
documents. Files that only included one date were not included in this part of the analysis, since more
than one date is needed to calculate the timeframe of the certification decision. The model output
provided dates for 61 of the 183 certification decision documents. As with the machine reading model
for certification decision types, the code captured surrounding text for more context around the date
extracted.

The machine reading model does not provide the calculations of the timing of certification decisions.
Instead, it outputs the different types of dates extracted (i.e., application date, public notice,
certification issued, application completed, and submitted request). In some cases, the machine reading
code exported two competing dates for certain events such as the public notice or application
submission. In these cases, EPA performed manual review of these certification documents and
determined the correct dates.

EPA took the output files from the model and calculated the time difference between (1) the
certification issuance date and the date the request for certification was received, (2) the certification
issuance date and the request for certification complete date, and (3) the date the request for
certification was received and request for certification complete date. With the need to manually
calculate the timing and verify dates in the output, EPA used the opportunity to manually review the
dates in the documents that the machine reading model extracted as discussed in the following section.

3.2.5.2.2 Manual Review

In an effort to check the accuracy of the machine reading model, EPA conducted a manual review of the
certification documents from which the machine reading model pulled dates. The machine reading code
that EPA used to inform the calculation of certification issuance timeframes occasionally extracted
incorrect dates. The amount of manual changes are reflected in the results in Table 3-5, which shows
the percentage of dates correctly identified by the machine reading model for three certifying
authorities. The model performed differently across the certifying authorities due to the document
structure and terminology used by the certifying authority. Most certification decision documents
contained at least one date (i.e., certification issuance date, date the request for certification was
received, date the request for certification was complete) that required manual correction. It is unclear
why the model missed certain dates, in particular dates that appeared around similar text and/or
position in other certification decision documents by the same certifying authority. Additionally, certain
formats may have caused the code to generate interpretation errors (e.g., various date formats).

41 To extract dates for assessing time to issue a certification decision, EPA used code that could match varying
dates in the text of the documents. The code identified text strings that follow the format of a word, followed by
two digits, followed by four digits, as in, February 29, 2020.

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Table 3-5. Percentage of certification decisions with certification dates correctly identified by
machine reading

Certifying
authority

% Application date or
Submit request date
correctly identified by
machine reading

% Certification issue
date correctly identified
by machine reading

% Application complete
date correctly identified
by machine reading

California
(Water Board of
San Diego)

76%

14%

24%

New Hampshire

0%

0%

N/A

Washington

57%

0%

0%

1For four of the Washington certification decisions, the machine reading output identified the correct "submit
request date" for manual verification; because the correct date still required manual verification and correction,
the Agency is not counting these four PDFs in the percentage of correctly identified "submit request dates."

As mentioned above, the Agency calculated three different timeframes: (1) time between certification
issuance date and the date the request for certification was received, (2) time between certification
issuance date and the request for certification complete date, and (3) time between the date the
request for certification was received and the request for certification complete date. Table 3-6 below
includes the total number of PDFs (from the 61 PDF files identified in the machine reading output) with
the relevant dates to conduct the timeframe determinations. Table 3-7 also includes the total number of
PDF files with at least one corrected date used to calculate the timeframes.

The Agency calculated summary statistics (i.e., minimum, maximum, median, average days) for each
timeframe determination. First, the Agency considered the time between certification issuance date and
the date the request for certification was received. From this sample of certification decision
documents, the results show a median value of 178 days and an average of 244 days.42 Next, the Agency
considered the time between the certification issuance date and the request for certification complete
date. From this sample of the certification decision documents, the results show a median value of 84
days and an average of 151 days. Lastly, the Agency considered the time between the date the request
for certification was received and the request for certification complete date. From this sample of
certification decision documents, the results show a median value of 152 days and an average of 171
days of wait time between the certifying authority initially receiving a request for certification and the
request for certification being deemed complete.

While the table below considers certification complete date, where available, the Agency did not
analyze the certification decision documents to determine other relevant circumstances and/or
information that might further inform the length of the timeframes (e.g., license or permit type, project
type). When looking at the time between certification issuance date and the date the request for
certification was deemed complete, only one certification decision was over the one-year statutory
maximum timeframe for CWA section 401 (2017.03.09_SanDiegoYachtClub). The Agency did not analyze
whether there was a difference in the timeframes between the 1971 Rule and 2020 Rule due to

42 The document with the maximum time between the date the request for certification was received and the
certification issuance date (2,457 days) is an extreme outlier. The values in this row of Table 3-6 would change to
40, 740,177 and 207, were this one outlier dropped from the analysis. It was not; this information is shared to
provide context.

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inadequate sample size. Additionally, the Agency did not analyze the certification decisions to determine
the reason the request for certification was not deemed complete and/or whether the reasons for
incompleteness were readily apparent to project proponents prior to submitting their request for
certification. However, as discussed in Section 3.2.2, certifying authorities previously have indicated that
delays are associated with project proponent failure to submit additional information. See Section 4.2
and Section 4.3 for further discussion on the final rule's approach to the pre-filing meeting requests and
the contents of a request for certification, which should ensure project proponents have a clear, early
understanding of the information required to start the certification process and avoid delays in starting
the certification process.

Table 3-8. Timeframes between Certification Dates

Timeframe
Determination

Total #
PDFs
with
dates

Total #
PDFs with

dates,
corrected

Summary Statistics

Minimum
(days)

Maximum
(days)

Median
(days)

Average
(days)

Time between certification
issuance date and the date
the request for certification
was received1

61

50

40

2457

178

244

Time between certification
issuance date and the
request for certification
complete date2

24

21

22

686

84

151

Time between the date the
request for certification was
received and request for
certification complete date3

24

19

2

472

152

171

1EPA determined the certification issuance timeframe by calculating the difference between the certification
issue date and the date the request for certification was received. For certifications decisions with a missing
certification issue date, EPA used the associated document date. Certification decisions analyzed by state: 29
from California Water Board of San Diego, 2 from New Hampshire, 30 from Washington.

2EPA determined the certification issuance timeframe by calculating the difference between the certification
issue date and the request for certification complete date. Certification decisions analyzed by state: 21 from
California Water Board of San Diego, 3 from Washington.

3EPA calculated the time between the date the request for certification was received and the request for
certification complete date, when both date types were available. Certification decisions analyzed by state:
21 from California Water Board of San Diego, 3 from Washington.

3.3 Federal Agency Data on License and Permits by Certifying Authority

Table 3-7 presents summary information for Federal license/permits that may require section 401
certification. This table includes the annual average number of Federal licenses or permits issued that
may require section 401 certification; this table does not include state permits or licenses (e.g., state
issued NPDES permits).43 The table provides separate values for general and individual permits, when

43 Most CWA section 404 permits are Federal permits, although a few states (Michigan, New Jersey, Florida) have
assumed implementation of the CWA section 404 permit program. Most CWA section 402 permits are state-issued
permits; only three states do not have any NPDES authorization and therefore all NDPES permits issued in those
states are Federal permits (Massachusetts, New Hampshire, New Mexico).

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applicable. General permits provide streamlined procedures for project proponents by authorizing
categories of discharges or simplified review procedures when the discharges comply with specified
requirements, whereas individual licenses and permits are customized to a specific project and
discharge(s).

Table 3-9: License and permit summary data by certifying authority

License/Permit Type

Annual Average # Federal
Licenses/Permits lssuedJ

Timeframe set by Federal Agency for
Section 401 Review

CWA section 404

45,725 general;
1,898 individual15

60 days - 1 year

Rivers and Harbors Act section
10

7,600 general;
1,391 individual0

60 days - 1 yearh

CWA section 402

16 general;
125 individual

60 days'

Rivers and Harbors Act section 9

40e

1 year6

Federal Energy Regulatory
Commission license

44f

1 yearJ

Nuclear Regulatory Commission
license

2g

1 year

Totals

53,341 general;
3,500 individual



a.	Includes all permits issued by the relevant Federal agency (section 401 certification either granted, granted with conditions, or waived). Due
to data limitations, EPA is not able to estimate the proportion of licenses/permits in the summary that are subject to section 401 certification.

b.	Estimate based on the annual average number of 404 permits from 01/01/2010 - 09/01/2020 based on counts provided by the Corps.

c.	Estimate based on the annual average number of section 10 permits from 01/01/2010 - 09/01/2020 based on counts provided by the Corps.

d.	Estimate based on the annual average of EPA-issued section 402 permits from 2010-2020.

e.	Estimate based on personal communication with Bridge Permits and Policy Division, Coast Guard Bridge Program.

f.	Estimate based on annual average license issuance for hydropower facilities/major natural gas pipelines from 01/01/2010 - 09/01/2020
(FERC, 2021a, 2021b)

g.	Estimate based on annual average license issuance for operating nuclear power reactors (full-power operating licenses and combined
operating licenses) from 01/01/2010 - 09/01/2020 (NRC, 2021)

h.	Timeframe depends on Corps district. Corps regulations (33 CFR 325.2) specify that waiver could occur if the certifying authority does not
issue a decision within 60 days. Historically, many Corps districts have allowed a longer timeframe.

i.	40 CFR 124.53(c)(3), unless unusual circumstances warrant a longer timeframe,
j. 18 CFR 4.34(b)(5)(iii)

h. The estimates for the last three permit average values were included in the totals as individual permits.

3.4 License and Permit Data Characterization

3.4.1 Section 404 Permits

The Corps issues two types of CWA section 404 permits, individual and general. Individual section 404
permits are for projects with more than minimal individual or cumulative impacts, while general section
404 permits are for activities that are similar in nature, cause only minimal individual adverse
environmental impacts when performed separately, and have only minimal cumulative environmental
impacts (U.S. EPA, 2021b). General permits automatically expire, unless renewed, every five years. There
are several types of 404 general permits, including Nationwide Permits (NWPs), Regional General
Permits (RGPs), and State Programmatic General Permits (SPGPs). The most common 404 general
permits are NWPs, which provide streamlined review and authorization for activity categories that are
determined by the Corps to have minimal adverse impacts, both individually and cumulatively, on the
aquatic environment. The Corps has 57 NWPs that are effective through March 2026 (Corps, 2021a;
2021b). RGPs are issued on a regional basis by an individual Corps district (Corps, n.d.-a). There is no
standard set of RGP activity categories that apply to all states, and there are varying numbers of RGPs
issued by different Corps Districts. The SPGPs are administered by the state agency and are designed to

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eliminate duplication of effort between Corps districts and states, as well as to make the permitting
process more flexible and efficient (Corps, n.d.-b).

3.4.2	Section 402 NPDES Permits

The NPDES permit program addresses water pollution by regulating point sources that discharge
pollutants to a WOTUS. For section 402 NPDES permits, section 401 certification only applies when EPA
(a Federal agency) is the permitting authority. Program components of NPDES include the NPDES permit
program, authority to regulate Federal facilities, pretreatment program, general permits program, and
biosolids program (U.S. EPA, 2019), and a state may receive authorization to administer one or more of
the NPDES program components. EPA retains administration for the program components for which a
state is not authorized. For example, if the state has not received authorization for Federal facilities, EPA
issues permits to Federal facilities (e.g., military bases, national parks, Federal lands, etc.), and the state
would have input on the permit via section 401. EPA is the sole NPDES permitting authority for three
states (Massachusetts, New Hampshire, and New Mexico), the District of Columbia, all U.S. territories
except the Virgin Islands, and generally on Tribal lands. All other states and the Virgin Islands have
authorization to issue section 402 permits for either the entire NPDES program or certain components.

The two basic types of NPDEs permits are individual and general permits. NPDES individual permits are
project-specific. Typically, dischargers seeking coverage under a NPDES general permit are required to
submit a notice of intent to be covered by the permit. NPDES general permits cover discharges meeting
general permit eligibility requirements in areas where EPA is the NPDES permitting authority (see U.S.
EPA, 2017).

3.4.3	Interstate Natural Gas Pipeline and Hydropower Project Licenses

Projects requiring interstate natural gas pipeline and hydropower project licenses, which are issued by
FERC (FERC, 2020), are also subject to section 401 certification. Certifying authorities typically review
section 401 certification requests for these projects rather than waiving review.

3.4.4	Rivers and Harbors Act Sections 9 and 10 Permits

Rivers and Harbors Act sections 9 and 10 permits cover construction of structures in navigable waters.
Section 9 permits authorize construction of bridges and causeways, which fall under U.S. Coast Guard
jurisdiction, as well as dams and dikes, which fall under Corps jurisdiction. Section 10 permits authorize
construction of wharfs, piers, dolphins, booms, weirs, breakwaters, bulkheads, jetties, and other
structures, which all fall under Corps jurisdiction.

3.4.5	Nuclear Power Plant Licenses

NRC issues licenses for nuclear power plants, which are often subject to section 401 review since they
are often located adjacent to waters to support the power generation equipment and sometimes
discharge cooling water (U.S. Energy Information Administration, 2021a). According to the Energy
Information Administration (2021b), "[a]s of September 1, 2021, there were 55 commercially operating
nuclear power plants with 93 nuclear power reactors in 28 U.S. states."

3.4.6	Mining Licenses

The USDA Forest Service and BLM are responsible for management of surface resources and
government-owned minerals on National Forest Service lands. The Forest Service and BLM therefore
must approve mine plans of operations before mining activity can take place. Other approvals, such as
section 404 permits, may also be required for such activities.

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3.4.7	Tennessee Valley Authority Shoreline Permits

The Tennessee Valley Authority (TVA) is responsible for protecting the shorelines within the Tennessee
River watershed. Under Section 26A of the TVA Act, the TVA issues shoreline permits for construction
projects that take place on shorelines in the Tennessee River watershed. These permits must be
obtained before construction on projects can begin. Permits are issued by the TVA after they conduct a
site visit and an environmental and programmatic review (TVA, n.d.-a). Shoreline permits are required
for all construction activities on shorelines including construction on docks, boathouses, piers,
walkways, and other shoreline stabilization activities (TVA, n.d.-b).

3.4.8	Alcohol and Tobacco Tax and Trade Bureau Permits for Alcohol Producers and Manufacturers
The Alcohol and Tobacco Tax and Trade Bureau (TTB) issues permits to alcohol and tobacco businesses,
including wineries and distilled spirit plants (TTB, 2019). Prospective industry members must apply for a
permit and receive TTB approval before they can commence operations. The required documentation
differs based on the type of permit, the applicant's business structure, and the applicant's potential
Federal excise tax liability (TTB, 2021).

3.5 Limitations and Uncertainties

3.5.1	Information from Certifying Authority Websites, Pre-proposal Input, and Public Comment
Only five of the 56 states and territories list the average annual number of certifications approved
and/or denied on their websites. No state or territory websites provide information about how often
they waive section 401 review.

Of the 56 state and territory websites searched, 18 did not have any information on section 401 fees.
These states or territories either do not charge a section 401 fee, or their section 401 fees are not
documented on their websites. For the states and territories with listed fees, some fees appear large for
reviews solely for section 401 purposes and may be part of a larger permitting fee. For example, the fee
range listed for Alabama's section 401 process ranged from $800-$25,920. The $800 minimum fee is
listed for several project types, while the $25,920 fee is listed for "commercial and residential
development 100 acres or greater in size" (AL DEM, 2021).

As summarized in Section 3.2, some states provided information about their average annual number of
certification decisions and average issuance times in pre-proposal input letters and public comments.
Although this information helps establish the section 401 baseline, the available data are not sufficient
for developing a nationally representative dataset for the annual average number of section 401 reviews
conducted and the resulting certification decisions.

3.5.2	Federal License and Permit Summary

Table 3-7 in Section 3.3 presents the average annual number of issued Federal licenses and permits for
six licensing/permitting categories. However, the annual average number of licenses and permits issued
does not capture the totality of section 401 certification reviews because the numbers do not account
for certification requests that may be denied by certifying authorities or withdrawn by project
proponents. Lastly, some licenses/permits in Table 3-7 may not meet the requirements that trigger
section 401 certification, but EPA is unable to estimate the proportion of licenses/permits that require
section 401 certification due to data limitations.

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4 Potential Effect of Final Regulatory Revisions

EPA is finalizing a new certification rule that promotes efficiency and certainty in the certification
process, that is well-informed by stakeholder input, and that is consistent with the cooperative
federalism principles central to CWA section 401. EPA's efforts to reconsider the 2020 Rule identified
certain procedural components of the 2020 Rule that adversely impacted the certification and
licensing/permitting process. These efforts and subsequent stakeholder input informed the final rule
provisions.

Overall, EPA anticipates that the final rule will result in more predictable, efficient decision-making by
certifying authorities relative to either the 2020 Rule or 1971 Rule baseline. Additionally, the final
changes are expected to improve certifying authorities' ability to protect water resources. Improved
water quality protection is the main benefit anticipated to result from final changes to several
provisions.44 Although the final rule may impose some additional burdens on certifying authorities (e.g.,
reasonable period of time negotiations relative to both baselines) and project proponents (e.g., pre-
filing meeting requests and participation relative to the 1971 Rule baseline), the Agency expects that
clear, unambiguous procedural requirements will improve section 401 procedural efficiencies for both
certifying authorities and project proponents. The final rule clarifies ambiguities in the current section
401 process, including scope, modifications, neighboring jurisdiction assessments, and procedures when
EPA acts as the certifying authority. These revisions help standardize the certification process, reduce
confusion, and promote efficient section 401 reviews. The final rule provides a means for Tribal
governments to obtain TAS for section 401 and/or section 401(a)(2) directly, which will limit costs for
Tribal governments interested in obtaining TAS for section 401 and/or 401(a)(2) that do not want to
administer the section 303(c) program for WQS.

Sections 4.1 through 4.11 summarize each final rule provision—including a description of the 1971 Rule
and 2020 Rule requirements, the final change, and the rationale for the final change—and discuss
potential effects of each final rule provision on certifying authorities, project proponents, other
stakeholders, and the environment, as compared with the 1971 Rule and 2020 Rule baselines. Section
4.12 discusses potential regulatory revisions that Federal agencies and certifying authorities may make
in response to the final rule. Section 4.13 discusses the Information Collection Request (ICR) for the final
rule. Section 4.14 summarizes in a table (Table 4-1) the potential effects of the final regulatory revisions
relative to both the baselines. Table B-l in Appendix B compares rule provisions, in plain language,
under the 1971 Rule, the 2020 Rule, and the final rule.

44 Use benefits are values individuals hold for an environmental improvement that can be inferred through a
change in demand for one or more market goods (i.e., purchases of complementary goods such as equipment and
travel), and nonuse benefits are values individuals hold for an environmental improvement that are independent
of purchases of market goods and services. The total benefits of an environmental improvement are the
combination of use and nonuse benefits (Freeman III et al., 2014). Recent economic literature provides substantial
empirical support that nonuse values, such as option and existence values, are greater than zero, and small per
capita nonuse values held by a substantial fraction of the population can be very large in the aggregate.

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4.1	When Section 401 Certification Is Required

4.1.1	Summary of Provision

•	2020 Rule and 1971 Rule requirements: 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 2020 Rule explicitly provided in the regulatory text that
certification is required for any activity that may result in a discharge. "Discharge" for purposes
of section 401 is also defined in the 2020 Rule as a discharge from a point source into a water of
the United States, consistent with Oregon Natural Desert Ass'n v. Dombeck, 172 F.3d 1092 (9th
Cir. 1998). While not addressed in the 1971 Rule, case law from the 9th Circuit holds that only a
point source discharge triggers section 401 (Oregon Natural Desert Ass'n v. Dombeck, 172 F.3d
1092 (9th Cir. 1998)).

•	Description of final regulatory change: The final rule explicitly reaffirms the longstanding
Agency position that section 401 certification is required for any Federal licenses or permits that
authorize any activity which may result in a point source discharge into waters of the United
States. The preamble reaffirms that the Agency interprets discharge to include, but not be
limited to, the discharge of pollutants, consistent with the holding in S.D. Warren Co. v. Maine
Bd. ofEnvtl. Prot., 547 U.S. 370 (2006). Additionally, the preamble reaffirms that discharges
must be from point sources to require section 401 certification. Dombeck, 172 F.3d 1092. This
interpretation is consistent with the Agency's longstanding interpretation of section 401 and the
judicial precedent mentioned above. See section IV.A in the preamble for further discussion of
this aspect of the final rule.

•	Rationale for final regulatory change: This provision reaffirms existing regulatory practice and
continues to provide clarity for stakeholders involved in the certification process.

4.1.2	Potential Impacts of the Provision

4.1.2.1	2020 Rule as the Baseline

The final provision substantively replicates the 2020 Rule provision regarding when section 401
certification is required. As such, relative to the 2020 Rule baseline, this final rule provision does not
have any potential impacts.

4.1.2.2	1971 Rule as the Baseline

The final provision clarifies when section 401 certification is required for certifying authorities, Federal
agencies, and project proponents. Increased clarity on the section 401 certification process and
implementation was a common request during pre-proposal feedback and public comment across
stakeholder groups, and the final rule addresses these requests by codifying existing practices in the
section 401 certification process. Overall, the increased clarity that will be gained from the final
provision will result in small environmental benefits from improvements in the section 401 review
process and small cost savings for certifying authorities, Federal agencies, and project proponents.

4.2	Pre-filing Meeting Requests

4.2.1 Summary of Provision

•	2020 Rule and 1971 Rule requirements: Pre-filing meetings were introduced in the 2020 Rule.
Project proponents were required to request pre-filing meetings at least 30 days prior to
requesting certification. Under the 2020 Rule, certifying authorities did not have to grant the
request for a pre-filing meeting, but they could not waive the 30-day wait period to submit a

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request for certification. See 40 CFR 121.4 (2020). There was no requirement for early
engagement between any section 401 stakeholders in the 1971 Rule or in the statute.

•	Description of final regulatory change: EPA is retaining the 2020 Rule requirement for project
proponents to request a pre-filing meeting with the certifying authority at least 30 days prior to
submitting a certification request. However, under the final rule, certifying authorities may
shorten or waive this pre-filing meeting request requirement and direct the project proponent
to proceed with submitting a certification request. See section IV.B in the preamble for further
discussion of this aspect of the final rule.

•	Rationale for final regulatory change: Many commenters recognized that pre-filing meetings
can facilitate and streamline the certification process through early coordination. Several
commenters supported the flexibility included in the proposed rule giving certifying authorities
the ability to waive or shorten the requirement. Pre-filing meeting requests ensure that
certifying authorities have an opportunity to receive early notification of and discuss the project
and potential information needs with the project proponent before the statutory "reasonable
period of time" for certification review begins (e.g., allow the certifying authority to collect
important details about a proposed project and its potential effects on water quality). The final
rule provides flexibility for certifying authorities to decide whether to require pre-filing meeting
requests based on project complexity and other factors, and supports cooperative federalism,
allowing states and Tribal governments to choose which projects or scenarios, if any, require
early coordination. The ability to waive a pre-filing meeting may be especially beneficial for
certifying authorities (including Tribes with TAS) with limited resources under their existing
section 401 programs, or for projects of limited scope and impact.

4.2.2 Potential Impacts of the Provision

4.2.2.1	2020 Rule as the Baseline

The final rule allows certifying authorities to waive the 30-day waiting period, at their discretion,
following receipt of a pre-filing meeting request. The final provision allows greater flexibility to certifying
authorities and project proponents when initiating the section 401 review process and will reduce delay
when pre-filing meetings are not needed for a particular project, which will result in cost savings for
both certifying authorities and project proponents relative to the 2020 Rule baseline.

4.2.2.2	1971 Rule as the Baseline

Although pre-filing meetings will place additional burden on both project proponents and certifying
authorities (unless certifying authorities waive the requirement for a pre-filing meeting request), the
process is ultimately expected to reduce burden elsewhere in the section 401 certification process.
Informal engagement often occurs in the baseline after receipt of a certification request, such as when
certifying authorities request additional information from project proponents to make a certification
decision. The informal engagement often occurs at multiple points throughout the section 401 review
process. The pre-filing meeting provides a more formal engagement opportunity between project
proponents and certifying authorities prior to the initiation of the certification review process, which
may help project proponents provide relevant information in the initial request for certification, help
certifying authorities act within the reasonable period of time, and reduce back-and-forth
communication between project proponents and certifying authorities. The requirement in the final rule
for project proponents to submit a pre-filing meeting request provides certifying authorities with the
option to learn about and discuss proposed projects prior to receiving requests for certification, which

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represents an improvement from the baseline scenario. Pre-filing meetings benefit certifying authorities
and project proponents by helping both parties to understand the proposed project and the type of
information or data that may be necessary for a timely and complete section 401 review. It may also
allow states to initiate their public notice processes more rapidly and provide better information for
public comment.

Under the 1971 Rule baseline, the section 401 process is often delayed by incomplete section 401
requests. The Tennessee Department of Environment and Conservation (TDEC), for example, shared in
pre-proposal input that their average time to process certification requests was often delayed because
the initial requests lacked sufficient information to analyze water quality impacts and solicit public input.
On average, TDEC reported a 120-day waiting period after receipt of the initial request for obtaining the
information necessary to make a certification decision.45 Alternatively, states that already utilize pre-
filing meetings noted fewer delays due to incomplete requests. For example, the Wyoming Department
of Environmental Quality (WDEQ) stated in its pre-proposal input letter that the section 401 review
process can be completed within 60 days by properly using pre-filing meetings. WDEQ frequently
encourages project proponents to submit pre-filing meeting requests at the conceptual or 30% design
phase of the proposed project. WDEQ often includes several stakeholders in the pre-filing meeting
process and discusses several projects at meetings with larger entities that are filing for multiple Federal
licenses or permits. For certain projects, WDEQ also participates in the early stages of the National
Environmental Policy Act review process to facilitate an efficient section 401 review process.46 In
addition to facilitating efficient section 401 reviews, early engagement may improve the quality of
section 401 reviews by helping to ensure that necessary information is available prior to or early in the
reasonable period of time, which may improve compliance with water quality requirements.

Flexibility in the pre-filing meeting provision minimizes burden on certifying authorities and project
proponents. If a certifying authority decides to categorically waive pre-filing meetings for certain project
types and makes that information publicly available, the project proponent does not have to request a
pre-filing meeting and may proceed without any delay. Similarly, if a certifying authority declines a pre-
filing meeting after a project proponent submits a pre-filing meeting request, the project proponent can
proceed with submitting a request for certification without any additional delay. If a certifying authority
decides to require a pre-filing meeting, the final rule clarifies that the project proponent must request
the pre-filing meeting at least 30 days before requesting certification. However, the certifying authority
may shorten the timeframe to reduce any delays in the certification process. Similarly, the certifying
authority may advise a project proponent to submit a pre-filing meeting request more than 30 days
before submitting a request for certification, as necessary, to ensure that the project proponent has
sufficient time to gather the appropriate information to submit a certification request and that the
certifying authority can make a certification decision within the reasonable period of time.

The final rule requirement for project proponents to submit a pre-filing meeting request to certifying
authorities for all projects, unless otherwise waived, will result in an additional time burden for project
proponents. The time burden increases when certifying authorities accept the request since project
proponents will be expected to participate in a pre-filing meeting. Additionally, project proponents may
be required to pay a fee for a pre-filing meeting. For example, Michigan uses a joint state and Corps

45	Tennessee Department of Environment and Conservation (EPA-HQ-OW-2021-0302-0083).

46	Wyoming Department of Environmental Quality (EPA-HQ-OW-2021-0302-0019).

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permit application, and project proponents currently have the option to request a pre-application
meeting for a fee up to $1,100 (Michigan Department of Environmental Quality, 2019). If pre-filing
meetings become more common as a result of this rulemaking, certifying authorities may consider
adding pre-filing meeting fees to help cover their administrative costs. Hence, project proponents may
be more likely to incur this monetary burden. However, EPA does not have information on which states
may impose these fees or the potential magnitude of such fees.

The burden of the pre-filing meeting provision on certifying authorities depends on multiple factors.

First, the burden depends on the magnitude of the change in the number of pre-filing meetings from the
baseline, as a result of the final rule provision. Some certifying authorities are already engaging in pre-
filing meetings with project proponents and may experience limited to no changes. Additionally, to
minimize costs and burdens on staff, certifying authorities can decline all meeting requests or choose to
decline meeting requests for routine or non-complex projects and only accept the meeting for larger or
complex projects. Second, the burden depends on the methodology that certifying authorities use to
conduct pre-filing meetings. Certifying authorities can use methodologies that would limit staff time and
resources, such as conducting the meeting online or via phone call. Lastly, the burden also depends on
whether a certifying authority implements a pre-filing meeting fee to help cover costs. EPA recognizes
that there is considerable uncertainty in estimating how certifying authorities will alter their current
practice in response to the final rule.

To demonstrate how the actions of certifying authorities may alter the time burden imposed by the final
rule requirement, suppose two scenarios: one in which the certifying authority accepts all pre-filing
meeting requests and another in which the certifying authority rejects all pre-filing meeting requests. In
the first scenario, the final rule requirement will lead to a large additional time burden for both
certifying authorities and project proponents. In contrast, in the second scenario, the final rule
requirement will not impose an additional time burden to certifying authorities.

In terms of process costs, EPA expects the final provision will result in cost savings for certifying
authorities since they will only accept the pre-filing meeting request when such meetings will be
beneficial for their section 401 review (i.e., for large or complex projects). However, the overall cost
effects are uncertain since the cost savings resulting from improved efficiencies may not exceed burden
of submitting pre-filing requests, participating in pre-filing meetings when accepted, and potential fees
that certifying authorities may charge for the pre-filing meetings.

4.3 Request for Certification

4.3.1 Summary of Provision

• 2020 Rule and 1971 Rule requirements: The statute states that a certifying authority's

reasonable period of time to act starts after the certifying authority is in "receipt" of a "request
for certification" from a project proponent (33 U.S.C. 1341(a)). The Agency defined both
"certification request" and "receipt" in the 2020 Rule and provided an exhaustive list of items
required in a certification request applicable to all certifying authorities. See 40 CFR 121.l(m),
121.5 (2020). The 2020 Rule required seven or nine components depending on whether the
request for certification was for an individual license or permit or the issuance of a general
license or permit. The 1971 Rule did not define either "request for certification" or "receipt."
The 1971 Rule also did not define what is required in a "request for certification" when states or
Tribal governments are the certifying authorities. However, when EPA is the certifying authority,

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the 1971 Rule required project proponents to submit a signed certification request with "a
complete description of the discharge involved in the activity/' which included five components.

•	Description of final regulatory change: The Agency is finalizing that any "request for
certification" must be in writing, signed, and dated. The final rule bifurcates the minimum
content requirements for an individual license or permit and the issuance of a general license or
permit. 40 CFR 121.5(a). 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 license or
permit application and any readily available water quality-related materials that informed the
development of the application. However, 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 license or permit and any readily available water quality-related materials that informed
the development of the draft license or permit. Beyond this requirement, EPA is not imposing
further requirements for states or authorized Tribes who choose to define additional contents
of a request for certification. See 40 CFR 121.5(c). Additionally, EPA is emphasizing that the
additional components of a request must be water quality-related, and that states and
authorized Tribes may define additional components of a request for certification in non-
regulatory vehicles, such as guidance. Furthermore, such additional components must be
identified prior to when the request for certification is made. When EPA acts as the certifying
authority and when a state or authorized Tribe does not define additional contents of a request
for certification, the final rule defines additional contents of a "request for certification." See 40
CFR 121.5(b). See section IV.C in the preamble for further discussion of this aspect of the final
rule. The Agency also added language to section 121.6(a) to clarify that the reasonable period of
time begins on the date that the certifying authority receives a request for certification, as
defined at 40 CFR 121.5, in accordance with the certifying authority's applicable submission
procedures.

•	Rationale for final regulatory change: Many commenters supported certifying authorities
having the ability to define the contents of a request for certification, saying that it ensures
states and authorized Tribes have the information they need to protect their water quality. In
order to effectuate Congress' goals for section 401 in the limited amount of time provided by
the Act, it is reasonable that certifying authorities should be able to define what information, in
addition to a copy of the 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 all requests for certification for
all certifying authorities could inhibit a comprehensive review under section 401 in the
reasonable period of time. The diverse nature of Federal licenses and permits, and the variety of
potential water quality impacts from those different types of activities, does not lend itself to a
one-size-fits-all approach. The Agency has also incorporated guardrails in the final rule to ensure
such additional contents are within the scope of the final rule and transparent, while still
allowing certifying authorities to act on a request for certification in a timely and informed
manner. To provide additional certainty and transparency, the Agency is only defining additional
contents of a "request for certification" when EPA acts as a certifying authority or for when a
state or authorized Tribe does not define additional contents. This provision balances both
transparency, efficiency, and flexibility for stakeholders. Additionally, in response to comments,

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the final rule requires the Federal license or permit application, as opposed to a draft license or
permit, for requests for certification on an individual license or permit. EPA's bifurcated
approach is consistent with longstanding certifying authority practices and should work well for
both individual licenses or permits as well as for the issuance of general licenses or permits.

4.3.2 Potential Impacts of the Provision
4.3.2.1 2020 Rule as the Baseline

Relative to the 2020 Rule, the final rule provides more flexibility in the request for certification
definition. The 2020 Rule included a prescriptive list of components for a request for certification and
did not allow certifying authorities to provide an alternative definition of a "request for certification."
Under the final rule, certifying authorities will be able to maintain their existing definitions or
components of a "request for certification," as long as the components are water quality-related and
clearly defined prior to the request for certification. The final rule also requires project proponents to
provide any readily available water quality-related materials that informed the application or draft
general license or permit, which recognizes the importance of providing certifying authorities with
critical information to inform their analysis while at the same time considering important
implementation considerations. First, this requirement provides a predictable endpoint for project
proponents because it is limited to existing data or information that was used in the development of the
license or permit application or the draft general license or permit. Second, consistent with the scope of
review under this final rule, this requirement limits any such materials to "water quality-related
materials," which will ensure that project proponents provide certifying authorities with pertinent water
quality-related information to fully inform their certification analyses. Since the provision affirms
longstanding section 401 practices and some states already have request for certification definitions in
regulations, guidance, or forms, EPA anticipates minimal costs for certifying authorities. Additionally, the
provision does not require certifying authorities to develop additional components for a request for
certification, nor does it prevent certifying authorities from requesting additional information after they
receive a request for certification.

The "request for certification" provision when EPA is acting as the certifying authority or when certifying
authorities have not provided their own definition will provide project proponents with greater clarity
and certainty regarding what contents to include in certification requests. More complete initial
certification requests may improve the quality of section 401 reviews and compliance with applicable
water quality requirements. However, project proponents with projects that span multiple jurisdictions
may also need to follow alternative definitions set by certifying authorities, which may be more
cumbersome than one standard definition across jurisdictions.

Defining the additional contents of a certification request, beyond the minimum contents listed in
section 121.5(a), when EPA is acting as the certifying authority or when certifying authorities have not
defined a "request for certification" in their regulations will help to improve request for certification
consistency by providing a backstop of information requirements. Although a list of required contents
may not be sufficient for all project types with various levels of complexity, the pre-filing meeting
provision of the final rule (see Section 4.2 above) will provide opportunities for certifying authorities to
discuss data needs with project proponents before the submission of requests for certification. The
provision will also provide flexibility for certifying authorities to define additional required contents of a
request for certification.

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The provision balances pre-proposal input and public comment received regarding certification
requests. Many stakeholders recommended that certifying authorities be responsible for determining
the information needed to process a complete certification request. Other stakeholders supported a
standard request for certification definition because it eliminated confusion as to when a project
proponent requests certification, created clarity and certainty around the timeline for certifying
authority action, and ensured the statutory clock began with the basic information needed for review.
Defining a request for certification when EPA is acting as the certifying authority or when certifying
authorities do not have their own definition provides the clarity and certainty desired by project
proponents while giving certifying authorities flexibility to set their own definition. Additionally,
requiring any state- or Tribal-defined additional components to be water quality-related and clearly
defined prior to the request for certification provides project proponents with further clarity and
certainty for meeting the "request for certification" requirements and initiating the reasonable period of
time.

Relative to the 2020 Rule baseline, this provision of the final rule will have positive environmental
benefits and cost savings for both certifying authorities and project proponents. The final rule's minimal
requirements will improve consistency of information provided in requests for certification via copies of
the license or permit application (or draft general license or permit), and any readily available water
quality-related materials that informed the application (or draft general license or permit) will improve
the quality of section 401 reviews, particularly for certifying authorities with limited resources.
Moreover, environmental benefits may be larger relative to the 2020 Rule baseline than relative to the
1971 Rule baseline because certifying authorities will be able to retain their own requirements for a
request for certification, which can be tailored to best ensure compliance with applicable water quality
requirements, instead of using the prescriptive list required by the 2020 Rule. In terms of process costs,
the provision will result in cost savings for project proponents by streamlining the process when EPA is
the certifying authority or when a certifying authority does not provide its own definition of a "request
for certification." For certifying authorities, the ability to retain their own "request for certification"
requirements may result in higher cost savings relative to the 2020 Rule baseline than relative to the
1971 Rule baseline.

4.3.2.2 1971 Rule as the Baseline

The 1971 Rule did not define what is required in a "request for certification" when states or authorized
Tribes are the certifying authorities. The final rule requirement to include the license or permit
application (or draft general license or permit) and any readily available water quality-related materials
that informed the application (or draft general license or permit) will help standardize the level of
information provided to certifying authorities. The final rule's minimal requirements for all requests for
certification may help certifying authorities conduct more complete section 401 reviews and better
ensure compliance with applicable water quality requirements. It is in the certifying authority's best
interest to clearly define information needs before the certification process begins in order to fully avail
themselves to the full reasonable period of time with all necessary information. Accordingly, with the
new requirement, certifying authorities will be less likely to request additional information from project
proponents to assess potential water quality impacts of the proposed project, which will increase
efficiency in the section 401 certification process. This increased efficiency can benefit both project
proponents and Federal agencies since licenses or permits may be issued more quickly. Section 4.3.2.1
in this economic analysis provides additional details about the ability for certifying authorities to

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maintain their existing "request for certification" definitions or components, and the requirement to
include a set list of components when certifying authorities do not have their own definition. When EPA
is the certifying authority or when certifying authorities have not defined their own additional "request
for certification" components, the final rule requires a set list of components in addition to the
minimum requirements at section 121.5(a), which will provide additional clarification to project
proponents and standardize the information that certifying authorities receive in certification requests.

Relative to the 1971 Rule baseline, this provision of the final rule will have similar positive
environmental benefits as compared to the 2020 Rule baseline. EPA expects the final rule will have
positive environmental benefits from higher quality section 401 reviews due to improved consistency of
information provided in requests for certification. Additionally, project proponents will experience cost
savings due to a more streamlined process when EPA is the certifying authority or when a certifying
authority defines additional contents for a "request for certification."

4.4 Reasonable Period of Time

4.4.1 Summary of Provision

•	2020 Rule and 1971 Rule requirements: The statute states that a certifying authority waives its
ability to certify a Federal license or permit if it does not act on a certification request within a
reasonable period of time, which cannot exceed one year (33 U.S.C. 1341(a)). Other than
specifying that the reasonable period of time "shall not exceed one year," the CWA does not
define the reasonable period of time. Under the 2020 Rule, Federal agencies were required to
set the reasonable period of time within 15 days of receiving the request for certification. The
2020 Rule provided that the reasonable period of time shall not exceed one year, as well as
factors that Federal agencies must consider in setting the reasonable period of time. Under the
2020 Rule, the certifying authority could not ask a project proponent to withdraw and resubmit
a certification request to restart the clock. The 1971 Rule reiterated from the statute that a
certifying authority would waive its certifying ability if it did not act within "a reasonable period
of time" and offered interpretations on two key reasonable period of time concepts: (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" (40 CFR 121.16(b)(2019)). Additionally, the Agency is aware
that there are instances where project proponents were asked to withdraw and resubmit a
certification request, even though the 1971 Rule was silent on this practice (see, e.g., Hoopa
Valley Tribe v. FERC, 913 F.3d 1099 (D.C. Cir. 2019)).

•	Description of final regulatory change: EPA is finalizing a process whereby the Federal agency
and certifying authority may jointly determine the length of the reasonable period of time on a
categorical or case-by-case basis. If the Federal agency and certifying authority do not jointly
determine the reasonable period of time, the reasonable period of time will default to six
months. The provision also identifies scenarios where the reasonable period of time will
automatically be extended upon notification by the certifying authority (i.e., when necessary to
accommodate a certifying authority's public notice procedures or force majeure events) but not
beyond one year from the receipt of the certification request. Lastly, the Federal agency and
certifying authority may jointly agree to extend the reasonable period of time once it has begun,
provided that the reasonable period of time does not exceed one year from the date that the

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request for certification was received. See section IV.D in the preamble for further discussion of
this aspect of the final rule.

• Rationale for final regulatory change: In pre-proposal input, some stakeholders asserted that
the 2020 Rule limited the role of state and Tribal authorities in setting the timeline for reviewing
certification requests. EPA expressed similar concerns about the lack of flexibility for certifying
authorities to inform the reasonable period of time in the Federal Register (U.S. EPA, 2021a).
Many commenters expressed support for the collaborative approach of the Federal agency and
certifying authority setting the reasonable period of time together. While still consistent with
statutory text, the final rule balances equities between certifying authorities and Federal
agencies. It provides the flexibility for cooperative federalism principles and allows certifying
authorities and Federal agencies to determine the best method for establishing the reasonable
period of time (e.g., case-by-case or on a categorical or programmatic basis). Alternatively, if the
agencies are unable to agree to a reasonable period of time, this option provides for a default
reasonable period of time of six months. This "default" approach obviates the need for a
potentially lengthy dispute resolution process in the event the certifying authority and Federal
agency disagree about the reasonable period of time.

4.4.2 Potential Impacts of the Provision
4.4.2.1 2020 Rule as the Baseline

Relative to the 2020 Rule baseline, the final rule gives certifying authorities greater opportunity 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), and public notice and comment procedures.
Negotiating the reasonable period of time upfront can improve the efficiency of the review process
(e.g., reduce the need for subsequent extension requests) and reduce the administrative burden on the
certifying authority. If a longer reasonable period of time is negotiated, the final rule gives certifying
authorities more time to review available information about potential water quality impacts of the
proposed project, and, if needed to fully assess potential water quality impacts, to request additional
information from project proponents. Additionally, the automatic extensions described in the final rule
will give the certifying authority greater flexibility to account for the public comment process or
unforeseen circumstances, such as a Federal government closure or natural disaster, which will further
reduce burden on certifying authorities.

The final rule clearly outlines the process for extending the reasonable period of time, which may reduce
the risk of certifying authorities issuing a denial due to a lack of time and necessary information to
conduct a proper review. Automatic extensions may also reduce the risk of certifying authorities issuing
project denials when unforeseen circumstances result in inadequate time to complete a review. A
consensus among certifying authorities in the pre-proposal input letters was that the Federal agency
typically set the reasonable period of time to be too short and did not account for adequate information
needs and project complexity and size. Commenters from the public comment period asserted that
Federal agencies lack the authority to unilaterally impose a shorter timeframe on certifying authorities.
Since certifying authorities will have more influence on setting the reasonable period of time under this
provision, the reasonable period of time may be longer on average than it would be if it was determined
unilaterally by the Federal agency. As a result, the provision to allow certifying authorities and Federal
agencies to jointly set the reasonable period of time can increase the risk of project delays as compared
to the baseline, though this effect may be limited to the CWA section 402 and section 404 permit

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programs (which currently have a default reasonable period of time of 60 days and which EPA expects
will be negotiated to stay at 60 days). Additionally, the potential for project delays can be offset by pre-
filing meeting coordination and a greater availability of information afforded to the certifying authority
at the beginning of the certification review process under the final rule. As noted in Section 3.2.3 above,
certifying authorities have delayed issuing certification decisions in the past due to incomplete
information.

Greater flexibility for the certifying authority to influence the reasonable period of time can lead to
more complete water quality impact analyses and better-informed certification decisions, which can
positively impact water quality and better ensure adherence to water quality requirements. Jointly set
reasonable period of time may provide more time for certifying authorities to include conditions, such
as monitoring and reporting conditions, in their certification decisions, which may improve water quality
protection but may also increase costs to the project proponent. Jointly setting the reasonable period of
time may also reduce the number of denials issued due to insufficient time to complete a certification
review, which will save time and reduce process-related costs for both certifying authorities and project
proponents. Overall, the greater flexibility and efficiency of the section 401 process under the final rule
may result in small positive environmental benefits.

The Agency expects many of the impacts described above to occur under both the 2020 Rule and 1971
Rule baselines. However, there may be additional potential impacts unique to the 2020 Rule baseline.
The final rule will not require Federal agencies to determine the reasonable period of time by 15 days
after receipt of a certification request. On average, Federal agencies may experience reduced
administrative burden as a result of the removal of this deadline but may also experience a shared
burden of negotiating the reasonable period of time with the certifying authority. Additionally, the 2020
Rule explicitly barred certifying authorities from asking project proponents to withdraw and resubmit
certification requests, while the final rule does not take a position on the validity or permissibility of
withdrawal and resubmission. In the pre-proposal input and public comment letters, industry
stakeholders stated that the 2020 Rule helped prevent certifying authorities from requesting that
project proponents withdraw and resubmit their certification requests. As a result, project proponents
may experience additional project delays under the final rule, as well as additional costs, if the
"withdraw and resubmit" practice is used. However, it is not clear what effect the 2020 Rule had on that
practice independent of published court decisions. EPA assumes that the "withdraw and resubmit"
approach has primarily been used when a certifying authority had inadequate water quality information
to issue a decision and was confronted by an imminent reasonable period of time deadline. Under the
final rule, it is likely that the certifying authority may not feel the need to request as much additional
information (necessitating "withdrawal and resubmit") because the approach to a request for
certification will have already required its submission. In such cases, the difference between the 2020
Rule baseline and the final rule for the reasonable period of time provision will be quite limited.
Additionally, the ability of the Federal agency and certifying authority to collaboratively set the
reasonable period of time will reduce the need for the "withdraw and resubmit" practice.47

This provision of the final rule may result in cost savings for certifying authorities. Certifying authorities
will have the ability to influence the reasonable period of time, and as a result, will have greater

47 To the extent this assumption is not accurate, a project proponent may experience more project delays under
the final rule to the extent that the "withdraw and resubmit" approach would continue to be relied upon.

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flexibility to conduct their section 401 reviews. These potential effects can translate into reduced
administrative burden for certifying authorities. Federal agencies, however, may experience incremental
costs from negotiating the reasonable period of time with certifying authorities.

4.4.2.2 1971 Rule as the Baseline

The Agency expects that many of the potential impacts of this provision will be the same with either the
1971 Rule or 2020 Rule as the baseline. For example, the Agency expects the potential impacts of
certifying authorities and Federal agencies jointly setting the reasonable period of time and negotiating
extensions to be identical relative to both baselines. Moreover, the potential impacts of automatic
extensions will also likely be the same under the two baselines. Similar to the 2020 Rule baseline, this
provision of the final rule can result in small environmental benefits due to the improved efficiency of
the section 401 review process. This provision may also result in net cost savings for certifying
authorities for the same reasons as discussed in Section 4.4.2.2 above.

A few potential impacts may be unique to the 1971 Rule baseline. The default reasonable period of time
of six months in the final rule is consistent with the 1971 Rule; however, allowing the Federal agency
and certifying authority to jointly negotiate the reasonable period of time can improve the efficiency of
the review process. The Federal agency and certifying authority can negotiate a shorter reasonable
period of time for projects that require less than six months to complete, and vice versa for projects that
take longer to review. Shorter reasonable period of time timeframes can reduce delays for the project
proponent, while longer reasonable period of time timeframes can increase delays. Overall, a joint
reasonable period of time process will better account for time considerations of both Federal agencies
and certifying authorities from the outset of the section 401 process, which will increase certainty
regarding section 401 review timeframes for certifying authorities, Federal agencies, and project
proponents.

4.5 Scope of Certification

4.5.1 Summary of Provision

• 2020 Rule and 1971 Rule requirements: Section 401(a)(1) provides that a certification must be
obtained by "any applicant for a Federal license or permit to conduct any activity .. . which may
result in any discharge into the navigable waters" (33 U.S.C. 1341(a)(1) (emphasis added)).
Section 401(d) provides that a certifying authority may place conditions in a certification that
are "necessary to assure that any applicant for a Federal license or permit will comply with"
water quality requirements. Id. at 1341(d) (emphasis added). The 2020 Rule took a narrowed
view regarding scope of review with a "discharge-only" approach that limited the scope of
review to whether a discharge from a federally licensed or permitted activity will comply with
water quality requirements. Water quality requirements were defined as the applicable
provisions of CWA sections 301, 302, 303, 306, 307, and state or Tribal regulatory requirements
for point source discharges into waters of the United States. The 1971 Rule did not explicitly
address the scope of certification in regulatory text. In 1994, the U.S. Supreme Court held 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. PUD No. 1 of Jefferson County v. Washington
Department of Ecology, 511 U.S. 700, 711-712 (1994). The Court also said its interpretation was
consistent with EPA's 1971 Rule at 40 CFR 121.2(a)(3) (2019) (requiring reasonable assurance

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that the "activity" will not violate applicable WQS) and with EPA's 1989 guidance (U.S. EPA,
1989).

•	Description of final regulatory change: The Agency is finalizing a return to the scope of
certification standard affirmed by the Supreme Court in PUD No. 1, which provides that a
certifying authority's section 401 review and conditions may address the water quality-related
impacts from the "activity" once section 401 certification has been triggered by the potential for
a point source discharge into a WOTUS. The final rule also addresses regulated community
concerns regarding 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. Under this approach, the certifying authority's evaluation is limited to
water quality-related impacts from the activity subject to the license or permit, including the
activity's construction and operation, regardless of whether those aspects are directly
authorized by the Federal license or permit that has triggered the need for certification. 40 CFR
121.3(a); see section IV.E in the preamble for further discussion of this aspect of the final rule.
The final rule also clarifies that the scope of review applies to any certification conditions
necessary to assure that the activity will comply with water quality requirements. 40 CFR
121.3(b). Furthermore, the Agency 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 quality-related requirement of state or Tribal law." 40 CFR

121.10).

•	Rationale for final regulatory change: During pre-proposal outreach and public comment, some
states and Tribal authorities raised concerns that the scope of the 2020 Rule limited their ability
to protect water quality. The final rule furthers the Administration's interest in enhancing and
supporting cooperative federalism. The final approach is also environmentally protective and
allows states and authorized Tribes to address, within the legal bounds of section 401, the
broadest possible range of adverse water quality effects from Federally licensed or permitted
projects. Furthermore, the "activity" interpretation of scope is the best interpretation of the
statutory text, is most consistent with the legislative history, realigns scope with accepted
practice for the 50 years preceding the 2020 Rule, best achieves the water quality protective
goals of the CWA, and is most harmonious with the cooperative federalism principles underlying
section 401. Lastly, the final rule's definition of "water quality requirements" interprets the term
in a way that respects the full breadth of the Federal and state and Tribal water quality-related
provisions that Congress intended a certifying authority to consider when determining whether
to grant certification.

4.5.2 Potential Impacts of the Provision
4.5.2.1 2020 Rule as the Baseline

Relative to the 2020 Rule, the final rule shifts the scope of review away from consideration of only
discharges associated with an activity authorized by a Federal license or permit towards consideration of
the water quality impacts from the "activity." As a result, with the 2020 Rule as the baseline, the final
rule will improve certifying authorities' ability to ensure compliance with water quality requirements
and therefore protect water quality. Additionally, relative to the 2020 Rule, certifying authorities will
face greater administrative costs from broadened section 401 reviews resulting from the final rule's
scope shift to "activity," as described in more detail below.

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Relative to the 2020 Rule, under which only impacts from discharges-could be considered, the final rule
has significant potential to generate noticeable water quality benefits, such as during the construction
phase of a project when land disturbance can lead to adverse stormwater runoff impacts and periods of
excessive downstream siltation that can significantly affect aquatic habitat. The expansion of the scope
of review relative to the 2020 Rule gives certifying authorities latitude to analyze a wide array of water
quality-related impacts from the activity, aside from the point source discharge, such as those created
by hydroelectric dams (e.g., sedimentation, change in aquatic habitats, trash pollution). Under the 2020
Rule, certifying authorities could not analyze the water quality impacts that did not arise from point
source discharges. As a result, certifying authorities may have been hampered from adequately
protecting water quality via certification decisions and conditions issued under the 2020 Rule. Certifying
authorities that would have analyzed such water quality impacts under the 1971 Rule but were
prohibited from doing so under the 2020 Rule will be able to do so again under the final rule. The 2020
Rule limited the ability of the certifying authority to consider the full range of possible water quality
impacts (and associated benefits and costs to society). In turn, the 2020 Rule increased the likelihood
that projects not beneficial to society due to water quality impacts (negative net benefits) were
approved. The "water quality requirements" definition included in the final rule provides clarity to
certifying authorities and project proponents about the scope of water quality impacts that are subject
to consideration under section 401. The final rule could discourage project proponents from applying for
Federal licenses or permits for projects with adverse water quality impacts, either from the discharge
itself or from other parts of the "activity," that would violate water quality requirements since they are
unlikely to receive a section 401 certification.

Conversely, relative to the 2020 Rule, there may be increased risk of project delays and associated costs
for project proponents. Water quality impact analyses could take longer when considering the "activity"
as opposed to the "discharge only." Certifying authorities may request additional information from
project proponents to consider the "activity" in their section 401 reviews. However, since these activity-
related data requests may address data that project proponents must compile in any event for the
Federal license or permit application, data requests for the section 401 process are unlikely to place any
incremental burden on project proponents. Additionally, project proponents may be responsible for
complying with a broader range of certification conditions due to the expanded scope of review (as
compared to the 2020 Rule).

This provision of the final rule will result in environmental benefits as more certifying authorities will
conduct more thorough water quality impact analyses with the expanded scope of review. The potential
environmental benefits associated with the change in scope will vary depending on the nature, size,
location, and type of projects that require a Federal license or permit. For example, when looking at a
hydropower project, the "activity" scope allows a certifying authority to consider water quality-related
impacts beyond the discharges from the tailrace or powerhouse. Depending on the activity specifics,
such consideration could result in certification conditions that 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
quality-related 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 and sedimentation from the operation and maintenance of the

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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. These conditions can
lead to water quality protections that result in improved ecosystem services that lead to use and nonuse
benefits. See Section 4.14 and Figure 4-1 for examples of ecosystem service benefits. Use benefits are
values individuals hold for an environmental improvement that can be inferred through a change in
demand for one or more market goods (i.e., purchases of complementary goods such as equipment and
travel), and nonuse benefits are values individuals hold for an environmental improvement that are
independent of purchases of market goods and services. The total benefits of an environmental
improvement are the combination of use and nonuse benefits (Freeman III et al., 2014). Recent
economic literature (see Section 4.14.1 below) provides substantial empirical support that nonuse
values, such as option and existence values, are greater than zero for environmental improvements, and
small per capita nonuse values held by a substantial fraction of the population can be very large in the
aggregate.

4.5.2.2 1971 Rule as the Baseline

Relative to the 1971 Rule interpretation of scope of review, the clarified scope of review in the final rule
gives certifying authorities more definitive authority to comprehensively analyze water quality impacts
related to a proposed activity. The clarified scope may provide greater assurance to certifying
authorities that they may analyze additional environmental impacts related to water quality. As a result,
certifying authorities may have greater ability to make better-informed certification decisions and
ensure compliance with water quality requirements. Moreover, certifying authorities will have clearer
authority to base certification decisions on water quality-related impacts from the "activity" rather than
water quality-related impacts resulting solely from the discharge. The final rule removes the need to rely
solely on case law and codifies the scope of the "activity" clearly for stakeholders. To that end, the
clarified scope of review in the final rule will likely reduce the risk of litigation against certifying
authorities by project proponents since the codified "activity" interpretation reduces the likelihood of a
condition or a denial being based on impacts outside of the section 401 scope of review.

The clarified scope of section 401 certification may lead to improved water quality protection,
particularly if certifying authorities were not considering the "activity" under the 1971 Rule baseline. To
illustrate, construction of a hydroelectric dam has much broader environmental implications than just
those at the point of discharge. Hydroelectric dams can significantly impact water quality beyond the
point of discharge by affecting fish migration patterns, downstream nutrient passage, build-up of
sediments, and aquatic habitats. Explicitly setting the scope of certification to the "activity" can lead
certifying authorities that were not considering this scope under the 1971 Rule baseline to analyze and
set conditions in accordance with water quality considerations from both the discharge itself and water
quality impacts beyond the discharge. As such, the clarified scope of section 401 certification could
better protect water quality and result in both use and nonuse benefits.

Most certifying authorities are likely already considering water quality-related impacts of the "activity"
when completing section 401 reviews because this is the standard set out by the U.S. Supreme Court in
1994 and is consistent with EPA's 1971 Rule. However, a small number of certifying authorities may see
increased administrative costs due to the final rule if they are not currently evaluating water quality-
related impacts from the "activity." Alternatively, a small number of certifying authorities that were

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previously considering impacts outside of water quality-related impacts can see reduced administrative
costs because of the final rule.

By clarifying the scope of review, the final rule will reduce the regulatory uncertainty of the section 401
review process for project proponents. The clarified scope can also reduce the risk of project delays
from certification denials that are based on analyses of impacts beyond those water quality-related
impacts of a proposed activity.

Relative to the 1971 Rule, this provision of the final rule may result in small positive environmental
benefits due to the clarification of the scope of review as the "activity." It is uncertain if certifying
authorities will experience incremental costs or cost savings because, relative to the 1971 Rule, some
may conduct more thorough section 401 reviews than they would have before the rule's scope
clarification. However, the clarified scope may also reduce risk of litigation (and the associated costs)
from project proponents against certifying authorities that, in addition to their thorough water quality
analyses, considered non-water quality-related issues. Project proponents may experience incremental
costs due to an increase in the risk of project delays and denials.

4.6 Certification Decisions

4.6.1 Summary of Provision

•	2020 Rule and 1971 Rule requirements: Section 401(a)(1) provides that a certifying authority
may grant a certification, grant a certification with conditions, deny a certification, or waive a
certification. The statute also says that, if a certifying authority fails or refuses to act on a
certification request within a reasonable period of time after receipt of such request, the
certification requirements shall be waived (33 U.S.C. 1341(a)(1)). Although EPA previously did
not explicitly define "to act" on a request for certification, the 2020 Rule took the position that
certifying authorities must make a decision on a certification request within the reasonable
period of time. The 2020 Rule and 1971 Rule defined what certifying authorities must include in
a certification or express waiver. The 2020 Rule required specific information to be included in
any decision document written by the certifying authority. See 40 CFR 121.7 (2020).

•	Description of final regulatory change: EPA is defining "to act on a request for certification" as
one of the four certification decisions (grant, grant with conditions, deny, or expressly waive) to
provide clarity and transparency about the certification process. Consistent with the previous
practice and regulations, waivers can happen in one of two ways: 1) by the certifying authority
expressly waiving review, or 2) by the certifying authority failing to act within the reasonable
period of time. Under this final rule, if the reasonable period of time defaults to six months, the
certification review is waived if the certifying authority does not act on the request for
certification within six months. In contrast to the 2020 Rule, the Agency is not finalizing a
mandatory list of requirements for certifying authorities to include in their certification
decisions. Instead, the final rule defines recommended contents for a grant of certification, a
grant of certification with conditions, a denial of certification, and an express waiver. See section
IV.F in the preamble for further discussion of this aspect of the final rule.

•	Rationale for final regulatory change: The final rule makes the Agency's prior position on what
it means "to act on a certification request" explicit and aligns with previous practice. Certifying
authorities have argued that the information requirements imposed under the 2020 Rule were
burdensome and should not be required. In response to these stakeholders and in support of

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the cooperative federalism balance central to section 401, the Agency is recommending but not
requiring contents for a grant of certification, a grant of certification with conditions, a denial of
certification, and an express waiver.

4.6.2 Potential Impacts of the Provision

4.6.2.1	2020 Rule as the Baseline

The additional clarity that "acting" equates to issuing a decision may help certifying authorities avoid
exceeding the reasonable period of time and waiving their section 401 authority. Relative to the 2020
Rule, the final rule will reduce the informational burden on certifying authorities because it does not
mandate the contents that certifying authorities must include in their certification decisions. Instead,
the final rule includes recommended contents for a grant of certification (section 121.7(c)), a grant of
certification with conditions (section 121.7(d)), a denial of certification (section 121.7(e)), and an express
waiver of certification (section 121.7(f)). 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. Reductions in the information burden on
certifying authorities may also benefit project proponents if the reduced informational burden on
certifying authorities leads to more timely certification decisions and, in turn, fewer project delays. The
final rule will also eliminate unnecessary potential disputes, sometimes in court, about whether a
certifying authority complied with EPA-issued requirements for certification decision documents. Lastly,
the recommended contents for a grant of certification, a grant of certification with conditions, a denial
of certification, and an express waiver will largely continue potential benefits from the 2020 Rule of
increased transparency in the certification process while providing certifying authorities with the added
flexibility to include different or additional information in their certification decisions. Although project
proponents may benefit from increased transparency in certification decisions, the additional flexibility
afforded to certifying authorities may reduce consistency of any increased transparency. The degree to
which certification decisions are made in a consistent manner depends upon how closely certifying
authorities follow the content recommendations.

The final rule provision may lead to environmental benefits as well. The reduced informational burden
on certifying authorities' certification decisions relative to the 2020 Rule may reduce constructive
waivers of certifications. Under the 2020 Rule, constructive waivers could occur if certifying authorities
did not comply with information requirements for conditions or denials, but under the final rule,
constructive waivers are limited to failure to act within the reasonable period of time. The potential
reduction in constructive waivers may help prevent harmful water quality impacts in constructive waiver
cases when certifying authorities intended to grant a certification with conditions or deny the
certification request.

4.6.2.2	1971 Rule as the Baseline

Relative to the 1971 Rule baseline, the final rule recommends contents for all certification decisions. The
recommended contents, to the extent that certifying authorities include them, will provide additional
transparency and clarity to project proponents and Federal agencies in the certification process. For
example, in the case of certifications granted with conditions, the final rule recommends that certifying
authorities provide reasoning for why the conditions are needed to assure that the activity will comply
with water quality requirements. Similarly, in the case of certification denials, the final rule recommends

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that certifying authorities provide information about the reason for denial (such as a description of any
missing water quality-related information if the denial is based on insufficient information). Project
proponents may be able to use this information to alter proposed projects to ensure compliance with
water quality requirements and submit a revised certification request. The magnitude of this benefit is
unclear since EPA is not aware of any major issues regarding clarity of information included in
certification denials or certifications granted with conditions.

Additionally, relative to the 1971 Rule, the final rule will reduce burden on certifying authorities since it
only includes informational recommendations rather than requirements for a grant of certification or
express waiver. Reductions in the information burden on certifying authorities may also benefit project
proponents if the reduced informational burden on certifying authorities leads to more timely
certification decisions and, in turn, fewer project delays.

The final rule encourages a more transparent process and may lead to a better-informed public
regarding why certifying authorities made certain certification decisions for specific projects. Lastly, the
final rule may result in environmental benefits if the clarified definition of "to act on a request for
certification" reduces the number of constructive waivers and ensures that certifying authorities are
able to review projects for potential conflicts with applicable water quality requirements, but the
reduction in constructive waivers may also increase costs for project proponents if the section 401
reviews result in certifications with conditions or denials.

4.7 Federal Agency Review

4.7.1 Summary of Provision

•	2020 Rule and 1971 Rule requirements: Section 401 does not explicitly provide a defined role
for Federal licensing or permitting agencies to review certifications. However, prior Agency
guidance acknowledged case law on the topic. Several circuit courts have recognized that
Federal agencies may review certification decisions only to see whether they meet the minimum
facial requirements of section 401, including whether the decision was issued within the
reasonable period of time, whether the certifying authority complied with its public notice
procedures, and whether the proper certifying authority issued the decision. See City ofTacoma
v. FERC, 460 F.3d 53, 67-68 (D.C. Cir. 2007), American Rivers v. FERC, 129 F.3d 99, 110-11 (2d. Cir
1997). Under the 2020 Rule, Federal agencies were required to review water quality certification
decisions to ensure that (1) the decision was made within the reasonable period of time, (2) the
certifying authority provided public notice on the certification request, and (3) the certification
decision included the informational requirements set out in the 2020 Rule. See 40 CFR
121.9(a)(2) (2020). If a Federal agency determined that a certifying authority failed to comply
with the aforementioned procedural requirements, then the certification could be deemed
waived under the 2020 Rule. Similarly, the Federal agency could find waiver with respect to
specific certification conditions that failed to meet informational requirements. See 40 CFR
121.9(b) (2020). The 1971 Rule provided that a Federal agency may determine that a waiver had
occurred if it determined that a certification decision was not issued within the reasonable
period of time. 40 CFR 121.16(b) (2019).

•	Description of final regulatory change: Consistent with case law and prior Agency guidance, the
final rule provides that to the extent a Federal agency verifies compliance with the requirements
of Clean Water Act section 401, its review is limited to whether: (1) the appropriate certifying

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authority issued the certification decision; (2) the certifying authority confirmed that it complied
with its public notice procedures established pursuant to Clean Water Act section 401(a)(1); and
(3) the certifying authority acted on the request for certification within the reasonable period of
time. Additionally, the Agency is not identifying the specific types of information that must be
included in a certification decision to satisfy Federal agency review and is instead relying on the
certifying authority to determine how to demonstrate that it met the facial requirements.
Consistent with the statutory text, the provision clarifies that if a certification decision is not
issued within the reasonable period of time, then a waiver occurs. If a Federal agency
determines that the certification decision was not issued within the reasonable period of time,
then the Federal agency shall promptly notify the certifying authority and project proponent in
writing that a waiver has occurred. 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. However, the Agency is declining to finalize regulatory text on the process
that Federal agencies and certifying authorities must follow for non-compliance with other facial
requirements of CWA section 401. See section IV.G in the preamble for further discussion of this
aspect of the final rule.

• Rationale for final regulatory change: The potential consequences of Federal agency review
required by the 2020 Rule drew considerable pre-proposal input and public comment to the
effect that the 2020 Rule's implementation 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.
The final rule clarifies that constructive waivers (as opposed to affirmative waivers) may only
occur for failure to act within the reasonable period of time, consistent with the plain language
of the statute and its legislative history. Additionally, the regulatory changes alleviate some
cooperative federalism concerns by expressly limiting Federal agency review to facial
requirements in section 401, consistent with certain case law and EPA's position prior to the
2020 Rule. The final rule clarifies the process that occurs once a Federal agency determines that
a certifying authority has failed or refused to act within the reasonable period of time. However,
the Agency is declining to define the process that Federal agencies and certifying authorities
must follow for non-compliance with other facial requirements of CWA section 401 (e.g., public
notice procedures, wrong certifying authority). This approach 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 required procedures.

4.7.2 Potential Impacts of the Provision
4.7.2.1 2020 Rule as the Baseline

The final rule provides that the certification requirement shall be waived only if a certifying authority
fails or refuses to act (i.e., grant, grant with conditions, deny, or expressly waive) on a request for
certification within the reasonable period of time. This provision reduces the number of constructive
waivers when compared to the 2020 Rule baseline, which allowed constructive waivers to occur for
failure to comply with procedural requirements in the 2020 Rule. Additionally, unlike the 2020 Rule, the
final rule does not require the Federal agency to review every certification decision. This change will
reduce burden in multiple ways: (1) reduced review time for Federal agencies, (2) reduced project
delays associated with the Federal agency review process, which is beneficial for project proponents,
and (3) reduced litigation associated with Federal agency review, which will save burden and costs for
Federal agencies, certifying authorities, and project proponents. Additionally, the final rule includes

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additional guidance by identifying, via preamble, certain ways in which a certifying authority may satisfy
Federal agency review. The clarity provided by the additional guidance may reduce burden on certifying
authorities associated with demonstrating compliance with facial requirements of section 401.

Relative to the 2020 Rule, the provision reduces the scope and potential impact of Federal agency
review by limiting review of a certifying authority's certification decision to three facial statutory
components of section 401, including failure to act within the reasonable period of time. The provision
responds to concerns about the potential for Federal agency review to undermine cooperative
federalism by making the scope of Federal agency review consistent with EPA's position prior to the
2020 Rule and relevant case law. The reduced scope of Federal agency review under the final rule may
lead to reductions in the number of constructive waivers for certification decisions that otherwise would
have been protective of water quality requirements. Thus, the reduced scope of Federal agency review
mitigates potential negative impacts of the Federal agency review process on water quality.

4.7.2.2 1971 Rule as the Baseline

Relative to the 1971 Rule baseline, constructive waivers may increase as a result of this provision if
Federal agencies review certification decisions more consistently and find that they exceed the
reasonable period of time. However, the statutory language is clear that a waiver occurs if a certification
is not issued within the reasonable period of time, and more consistent Federal agency review will
enforce this statutory stipulation. With more consistent Federal agency review, project proponents may
benefit from fewer project delays since certifying authorities will face having their certification decision
waived during Federal agency review if they exceed the reasonable period of time. The public may also
benefit from ensured involvement/engagement in the certification process since Federal agency review
includes confirming that the certifying authority complied with its public notice procedures.

4.8 EPA's Roles Under Section 401

4.8.1 Summary of Provision

•	2020 Rule and 1971 Rule requirements: The Agency has a number of specific roles under
section 401. 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)). The 2020 Rule placed restrictions
on EPA when it acts as a certifying authority by prescribing timeframes on the public notice
process and limiting requests for additional information. The 2020 Rule provided that EPA could
only request additional information that could be collected or generated within the reasonable
period of time. The 1971 Rule had provisions for when EPA acts as the certifying authority,
including a provision on the contents of a certification request, a process for making certification
decisions, and a process for pre-operation inspections pursuant to section 401(a)(4). EPA's
second role is to provide technical assistance as requested by Federal agencies, certifying
authorities, and project proponents for Federal licenses and permits. The 2020 Rule recognized
EPA's role to provide Federal agencies, certifying authorities, and project proponents with
technical assistance and information in regard to complying with water quality requirements.
The 1971 Rule acknowledged this role but limited it to providing technical assistance on WQS to
Federal agencies. A third role EPA plays is discussed in Section 4.10 below (neighboring
jurisdictions process).

•	Description of final regulatory change: The Agency is finalizing updates to the public notice
procedures in the 2020 Rule applicable to EPA when it acts as the certifying authority to provide

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greater flexibility. EPA is removing the 2020 Rule's limitations on EPA's ability to request
additional information. EPA is also clarifying that once EPA provides public notice on receipt of a
request for certification, EPA must provide an opportunity for public comment. The Agency is
also finalizing minor updates to the 2020 Rule provision on technical assistance. Under the final
rule, EPA can provide technical assistance on (1) applicable effluent limitations, or other
limitations, standards, regulations, or requirements, or water quality criteria, and (2) any
methods to comply with such limitations, standards, regulations, requirements, or criteria. See
section IV.H in the preamble for further discussion of this aspect of the final rule.

• Rationale for final regulatory change: The regulatory changes will provide EPA with flexibility in
the manner and methods of providing public notice when EPA is a certifying authority while
maintaining accountability provided by the public notice procedures. The provision removes the
2020 Rule's limitations on EPA's ability to request additional information to allow for more
informed certification decisions. The provision also makes minor conforming changes to the
2020 Rule's provision on technical assistance to be more consistent with the statutory language.

4.8.2 Potential Impacts of the Provision

4.8.2.1	2020 Rule as the Baseline

The 2020 Rule included the same 20-day timeframe as the final rule for providing public notice upon
receipt of a certification request. The 2020 Rule also did not limit the scope of a public hearing on the
certification process. As such, relative to the 2020 Rule, the final rule may not add as much regulatory
certainty or improve public engagement at the same magnitude relative to the 1971 Rule. However, the
final rule provision provides EPA with greater flexibility in determining the best manner to notify
stakeholders relative to both baselines, which may result in cost savings for EPA, and can improve
section 401 reviews and compliance with water quality requirements.

The 2020 Rule included provisions that limited the timeframe during which EPA could request additional
information from project proponents (initial request by 30 days after receipt of a certification request)
as well as the information that could be requested (information related to discharge only). As a result,
relative to the 2020 Rule, the final rule broadens the Agency's ability to request information from
project proponents. The broadened ability for EPA to request additional information has an uncertain
impact on project proponents. Although project proponents may face increased regulatory burden and
uncertainty from additional information requests, the increased flexibility for EPA to request
information may allow the Agency to make certification decisions in cases for which a denial was likely
to occur under the more restrictive 2020 Rule due to insufficient information. For such cases, the final
rule likely reduces overall burden for project proponents. Relative to the 2020 Rule, the final rule may
also improve the Agency's ability to assess compliance with water quality requirements, which can lead
to certification decisions that better protect water quality.

The 2020 Rule included similar technical assistance provisions as the final rule, including expansion of
technical assistance scope to include certifying authorities and project proponents. As such, the
potential impacts described in Section 4.8.2.2 below related to technical assistance do not apply under
the 2020 Rule baseline.

4.8.2.2	1971 Rule as the Baseline

Relative to the 1971 Rule baseline, the final rule provision is expected to be beneficial on several fronts.
First, defining a timeframe for public notice when EPA is the certifying authority (within 20 days

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following receipt of a certification request) will provide clearer guidance regarding the timeline that EPA
must follow. For project proponents, clearer guidance on public notice procedures will provide more
regulatory certainty. Additionally, defining the timeframe for public notice will provide more certainty to
the public regarding when public comment occurs, and increasing predictability of public comment
periods may improve public engagement. Such effects may ultimately improve section 401 reviews and
compliance with water quality requirements.

The final rule provision will also provide EPA with greater flexibility to determine the best manner and
method to notify stakeholders, which may result in cost savings for EPA. This flexibility will provide the
Agency with the latitude to reach the broadest number of potentially interested stakeholders, which
should also improve section 401 reviews and compliance with water quality requirements. The revision
to broaden the scope of EPA's technical assistance will reduce burden on certifying authorities and
project proponents by increasing the range of issues for which they can seek technical assistance from
EPA, including (1) any applicable effluent limitations, or other limitations, standards, regulations,
requirements, or water quality criteria, and (2) any methods to comply with such limitations, standards,
regulations, requirements, or criteria.

4.9 Modifications

4.9.1 Summary of Provision

•	2020 Rule and 1971 Rule requirements: The 2020 Rule did not include a certification
modification provision and instead relied on other Federal agency regulations to address
modifications (e.g., the NPDES regulations allow for certification modifications based on changes
in underlying law or in response to a court decision). 85 FR 42279. The 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).

•	Description of final regulatory change: The Agency is reintroducing a provision for modification
of granted certifications (with or without conditions), allowing certifying authorities and Federal
agencies to coordinate when circumstances warranting modification to a granted certification
arise at any time after a grant of certification is issued. EPA is not defining such circumstances,
but section 121.10 requires the certifying authority and Federal agency to agree in writing prior
to the certifying authority modifying the certification. The final rule states that the certifying
authority is not required to obtain the Federal agency's agreement on the language of the
modification itself. In addition, this provision clarifies that the certifying authority is not
permitted to revoke a grant of certification or to change a grant of certification into a denial or
waiver of certification under section 121.10. Unlike the 1971 Rule, the Agency is not including
EPA in the certification modification process where the Agency is neither the certifying authority
nor the Federal licensing or permitting agency. See section IV.I in the preamble for further
discussion of this aspect of the final rule, as well as a discussion on the improved clarity and
process limitations around modifications to a grant of certification.

•	Rationale for final regulatory change: In pre-proposal outreach and public comments,
stakeholders expressed interest in having a process for certification modifications to address
changing, unseen, or emergency circumstances relevant to water quality that may occur after a
certification has been issued. From a resource perspective, re-initiating the entire certification
process for each changing detail of a certified license or permit would be procedurally and

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financially burdensome to all parties and would not allow for efficient adaptive management.
The final rule is in line with cooperative federalism principles because it provides a balance
between the needs and authorities of the certifying authority, the Federal licensing or
permitting agency, and the project proponent.

4.9.2 Potential Impacts of the Provision
4.9.2.1 2020 Rule as the Baseline

Relative to the 2020 Rule, the final rule authorizes modifications to a grant of certification (with or
without conditions) within certain limits. The revisions will provide several benefits for certifying
authorities, Federal agencies, and project proponents, as well as the environment.

In response to the 2020 Rule's absence of a modification provision, some commenters called the
proposed modification provision an improvement over the 2020 Rule. Many commenters stated that
including a provision for certification modifications provides the ability to adapt to changes in
circumstance, such as changes to projects, water quality requirements, and environmental conditions
overtime. Several commenters added that modifications may be necessary to maintain water quality
protection when new information and data become available after the issuance of a certification, during
the life of the Federal license or permit. Some commenters asserted that modifications may be
necessary to account for unforeseen water quality impacts, particularly for projects that can last for
decades.

The final rule allows project plans to evolve after issuance of a grant of certification (with or without
conditions), providing added flexibility to project proponents while avoiding the burden of having to
seek a new certification for changes. Project proponents will face limited regulatory uncertainty because
this provision will require certifying authorities to first coordinate with the Federal agency before
modifying a certification. Requiring agreement between the certifying authority and the Federal agency
will protect the reliance interests of Federal agencies and project proponents by limiting the
circumstances under which certification modification can occur and, thus, prohibiting unilateral
modifications. The provision will also limit regulatory uncertainty for project proponents by clarifying
that the modification provision only applies to grants of certification (with or without conditions), and
that the certifying authority is not permitted to revoke or change a grant of certification into a denial or
waiver of certification through the process outlined in section 121.10.

Reintroduction of the modification process respects state and Tribal rights, as these jurisdictions are
often more familiar with local conditions and able to manage local waters more effectively. The final
provision is in line with the cooperative federalism principles of the CWA because it provides a balance
between certifying authority, Federal agency, and project proponent needs as projects change and new
information arises throughout the life of the Federal license or permit. Reintroducing the explicit ability
to modify certifications supports certifying authorities by preserving their ability to protect their water
resources in the event of changes to the water quality impacts of certified projects.

Relative to the 2020 Rule baseline, the final rule provision provides compliance and economic benefits
to certifying authorities, project proponents, and Federal agencies. The inability to modify certifications
might create costly project delays and increase state administrative costs if - due to changes - the entire
certification process needs to be reinitiated. From a resource perspective, reinitiating the entire
certification process - instead of modifying a certification that has already been granted - for each

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changing detail of a project, license, or permit is procedurally and financially burdensome to all parties
and does not allow for efficient adaptive management. Furthermore, some certifying authorities might
be inclined to issue more denials of certification if they do not possess a mechanism to evaluate new
data and information about long-term projects after issuing a certification decision.

4.9.2.2 1971 Rule as the Baseline

Relative to the 1971 Rule, the final rule clarifies the roles that certifying authorities, Federal agencies,
and project proponents play in the modification process, which will improve efficiencies and reduce
burden associated with modifications. The final rule provision also promotes the principle of cooperative
federalism and increases regulatory certainty in comparison to the 1971 Rule provision.

Unlike the 1971 Rule, the Agency is not including EPA in the certification modification agreement
process when the Agency is neither the certifying authority nor the Federal licensing or permitting
agency. As such, EPA is removing itself from the list of entities included in the 1971 Rule that must reach
agreement for most modifications to occur. This simplification may improve the likelihood of reaching a
modification agreement in cases when EPA is neither the certifying authority nor the Federal licensing or
permitting agency.

Relative to the 1971 Rule, the final rule provides more clarity around the limitations of the modification
process. The final rule clarifies that: 1) unilateral modifications cannot occur, and 2) the nature of a
certification decision cannot be changed {e.g., change a grant into a denial or waiver) through the
modification process. In addition, under section 121.10, certifying authorities and Federal agencies may
agree to modify a grant of certification (with or without conditions), but the certifying authority may
modify only those portions of the certification that the two parties agreed upon. The final rule is more
explicit than the 1971 Rule about the nature of the agreement - section 121.10 states that the certifying
authority is not required to obtain the Federal agency's agreement on the language of the modification
after obtaining agreement that the certifying authority may modify the granted certification. These final
changes promote regulatory certainty during the modifications process. As such, the final changes align
with the cooperative federalism principles of the CWA by providing a balance between the needs and
authorities of the certifying authority, Federal licensing or permitting agency, and project proponent.

4.10 Neighboring Jurisdictions Process
4.10.1 Summary of Provision

• 2020 Rule and 1971 Rule requirements: Section 401(a)(2) establishes a process for states and
authorized Tribes to participate in the Federal licensing or permitting process in circumstances
where a discharge originating in another jurisdiction may affect their water quality. This section
401(a)(2) process is referred to as the neighboring jurisdictions process. For purposes of
initiating this process, section 401(a)(2) requires a Federal agency to "immediately" notify EPA
upon receipt of a license or permit application and section 401 certification. Under the 2020
Rule, Federal agencies were required to notify EPA within five days of receiving the certification
and application for the license or permit. The 2020 Rule also defined the contents that EPA
would provide to neighboring jurisdictions when EPA makes a "may affect" determination, as
well as the contents required from a neighboring jurisdiction when it makes any "will violate"
objection. The 2020 Rule also 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. Under the 1971 Rule, Federal agencies were required to notify

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EPA upon receipt of an application and certification or waiver. 40 CFR 121.16 (2019). If the
documents did not contain sufficient information for EPA to make a "may affect" determination,
EPA could request supplemental information. 40 CFR 121.12 (2019). Within 30 days of receiving
notification, EPA may determine, at its discretion, that the discharge may affect the water
quality of a neighboring jurisdiction (which includes states and authorized Tribes). 40 CFR 121.13
(2019). If EPA makes a "may affect" determination under section 401(a)(2), EPA must notify the
neighboring jurisdiction, Federal agency, and the project proponent, and the neighboring
jurisdiction has 60 days to determine whether the discharge will violate its water quality
requirements, object to the license or permit, and request a hearing. The 1971 Rule established
a process for EPA to provide notification to neighboring jurisdictions in a manner similar to that
subsequently set forth in section 401(a)(2) in 1972.

•	Description of final regulatory change: The Agency is retaining the 2020 Rule process for
Federal agencies to "immediately" notify EPA by requiring notification within five days of
receiving an application and certification or waiver and finalizing a definition for the contents of
a notification. The Agency also agrees with the 2021 Fond du Lac court that EPA must determine
whether a discharge "may affect" a neighboring jurisdiction once it receives notification of the
application and certification or waiver.48 The Agency is also providing greater clarity regarding
factors it could consider in making a "may affect" determination in the preamble. Additionally,
EPA is revising the 2020 Rule's procedural framework for the neighboring jurisdiction objection
process under section 401(a)(2), including adding a provision for the notified neighboring
jurisdiction to withdraw its objection prior to the public hearing. See section IV.K in the
preamble for further discussion of this aspect of the final rule.

•	Rationale for final regulatory change: The final changes provide transparency to Federal
licensing and permitting agencies about the information EPA expects in section 401(a)(2)
notifications and streamlines EPA's section 401(a)(2) review by standardizing the timing and
content of notifications from Federal agencies. Most commenters addressing factors for EPA to
consider in "may affect" determinations supported EPA providing some identification of such
factors in the final rule. Such commenters noted that identification of factors clarifies and
provides broader understanding of EPA's process in making a "may affect" determination and
may improve efficiency in making this determination. The final rule preamble clarifies the
factors EPA may consider in making a "may affect" determination without inappropriately
limiting the Agency from considering other relevant factors or requiring it to apply factors where
they are irrelevant. Multiple commenters recommended that EPA include language allowing
neighboring jurisdictions to withdraw their objection before the hearing, therefore eliminating
the requirement to hold a public hearing. 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.

48 Fond du Lac Band of Lake Superior Chippewa v. EPA, 519 F.Supp.3d 549 (D. Minn. 2021).

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4.10.2 Potential Impacts of the Provision

4.10.2.1	2020 Rule as the Baseline

Some stakeholders indicated that the neighboring jurisdictions process is currently underused. Even
with more attention on this provision during the development and finalization of the 2020 Rule, EPA has
not seen a significant increase in the number of section 401(a)(2) actions to date. The final rule provision
improves and clarifies the Federal agency notification process by defining the contents of a Federal
agency's notice to EPA and allowing EPA to request supplemental information, which the 2020 Rule
limited to copies of the certification and the Federal license or permit application. The final rule
provision also allows EPA to enter into agreements with Federal agencies regarding the manner and
contents of notification.

Further, relative to the 2020 Rule baseline, the final rule will ensure that—following receipt of notice—
EPA assesses whether a project "may affect" a neighboring jurisdiction and, if so, provides notice to that
neighboring jurisdiction. Receipt of such notice will allow notified neighboring jurisdictions to conduct
their own review of the project to determine if a discharge from the project will affect the quality of its
waters so as to violate any water quality requirements in its jurisdiction. The 2020 Rule gave EPA
discretion regarding whether to make such a "may affect" determination for neighboring jurisdictions,
whereas the final rule clarifies that—upon receipt of notice—EPA must determine whether a discharge
"may affect" water quality in a neighboring jurisdiction. Mandatory "may affect" determinations may
have positive environmental impacts.

A potential increase in "may affect" determinations and neighboring jurisdiction objections can lead to
incremental costs to project proponents if the neighboring jurisdictions process results in more Federal
licenses and permits being granted with additional conditions or denied. However, the final rule also
clarifies that the neighboring jurisdiction may withdraw its objection before the public hearing, in the
case that the neighboring jurisdiction receives more information, no longer objects, and finds the public
hearing is no longer necessary. This addition in the final rule may help mitigate time delays and conserve
project proponent and Federal agency resources that would otherwise be expended to conduct and
participate in such a hearing in these circumstances.

4.10.2.2	1971 Rule as the Baseline

Greater clarity regarding the "may affect" interpretation provided by the final rule provision may
increase efficiency of neighboring jurisdiction assessments. In both pre-proposal input and the public
comment period, stakeholders recommended increased clarity on the "may affect" determination,
including the timing and process of EPA making the determination. Additionally, establishing a
procedural framework for objections and hearings under section 401(a)(2) and clarifying the information
that EPA expects in section 401(a)(2) notifications may reduce burden on Federal licensing or permitting
agencies, improve efficiency of neighboring jurisdiction assessments, and reduce project delays.
Clarifying that EPA must conduct a "may affect" determination once it receives notification of the
application and certification or waiver and the added procedural clarity may increase the number of
jurisdictions that decide to object or request a hearing on a Federal license or permit, which can lead to
incremental costs to project proponents if the neighboring jurisdictions process results in more Federal
licenses and permits being granted with additional conditions or denied. However, similar to the 2020
Rule baseline (Section 4.10.2.1), the final rule clarification that a neighboring jurisdiction may withdraw

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its objection before the public hearing helps mitigate time delays and conserve project proponent and
Federal agency resources.

Ultimately, clarifications regarding when neighboring jurisdiction assessments are required will help
bring stability to the neighboring jurisdiction assessment process. The revisions regarding when
neighboring jurisdiction assessments are required will help ensure that neighboring jurisdictions that
EPA determines may be affected by a federally licensed or permitted project have an opportunity to
provide input on whether the project complies with their water quality requirements and, thus, that the
section 401 process considers and accounts for potential effects on water quality in neighboring
jurisdictions. Consistent with the statute, if conditions added to the license or permit cannot ensure
compliance of water quality requirements in neighboring jurisdictions, the Federal agency cannot issue
the license or permit.

4.11 TAS and Other Tribal Issues
4.11.1 Summary of Provision

•	2020 Rule and 1971 Rule requirements: Under section 518 of the CWA, EPA may treat federally
recognized Indian Tribes in a similar manner as a state (TAS) for purposes of administering most
CWA programs for the Federal Indian reservations that they govern. 33 U.S.C. 1377. Neither the
2020 Rule nor the 1971 Rule included TAS provisions for section 401. In the absence of TAS
provisions solely for section 401, Tribes have received TAS for section 401 by obtaining TAS to
administer the section 303(c) program for WQS (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"). As certifying authorities, Tribes with TAS may waive certification
or grant, grant with conditions, or deny certification based on whether discharges from 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. As a neighboring jurisdiction, if
EPA makes a "may affect" determination, Tribes with TAS may object to projects if they
determine that the discharge "will violate" their water quality requirements, and request a
public hearing from the Federal licensing or permitting agency.

•	Description of final regulatory change: The final rule adds provisions for how Tribes may obtain
TAS solely for section 401, as well as provisions on how Tribes may obtain TAS for the limited
purpose of participating as a neighboring jurisdiction under section 401(a)(2). See section IV.L in
the preamble for further discussion of this aspect of the final rule.

•	Rationale for final regulatory change: The regulatory changes provide Tribes with a greater
ability to protect their water resources from the adverse effects of pollution from federally
licensed or permitted projects. The first change provides Tribes more options in deciding
whether to seek TAS for section 303(c), section 401, or both. Decoupling section 401 TAS
provisions from section 303(c) recognizes that section 401 and section 303 administration are
related but distinct functions. Several commenters also expressed concern about Tribes without
TAS being unable to participate in the section 401(a)(2) neighboring jurisdictions process,
asserting that waters on reservations are susceptible to degradation from upstream, off-
reservation discharges. The second change is responsive to Tribes who have expressed an
interest in the neighboring jurisdictions process and having a mechanism for objecting and
requesting a hearing on the issuance of Federal permits or licenses, even if they are not

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interested in issuing certifications (under section 401(a)(1)) and/or developing WQS (under
section 303(c)).

4.11.2 Potential Impacts of the Provision

4.11.2.1	2020 Rule as the Baseline

Relative to the 2020 Rule, the TAS provision of the final rule will provide several benefits. Providing a
pathway for Tribes to obtain TAS for section 401 (as a whole) or for section 401(a)(2) alone may improve
section 401 certification reviews and compliance with water quality requirements, as Tribes are most
familiar with their local waterways. The provision provides Tribes with the ability to obtain TAS for
section 401 (as a whole) or specifically for section 401(a)(2) without having to also meet requirements
for section 303(c). A separate pathway to obtain TAS for section 401 (as a whole) or for section 401(a)(2)
will provide Tribal stakeholders with more tools for ensuring that water quality requirements are met.
Project proponents may benefit from the final rule provision by working directly with Tribes as opposed
to EPA as the certifying authority, increasing clarity and efficiency.

As Tribes take a more active role in the section 401 certification process, there may be an increase in the
number of certifications granted with conditions or the average number of conditions added to each
certification, which may lead to an increase in costs for project proponents. These additional conditions
may lead to water quality benefits in Tribal waters. However, EPA anticipates that the increase in the
number of conditions will be minimal since EPA already adds conditions, on a Tribe's behalf, as needed
to assure compliance with Tribal water quality requirements. Tribes that newly obtain TAS for section
401 may require some time to learn the certification process, which may increase review time and
reduce efficiency in the short-term.

4.11.2.2	1971 Rule as the Baseline

Similar to the 2020 Rule, the 1971 Rule does not provide Tribes with the opportunity to receive TAS
solely for section 401. Therefore, the potential impacts of the final rule provision are the same under the
two baselines (see Section 4.11.2.1).

4.12 Potential Effects on Federal Agency and Certifying Authority Regulations
and Guidance

4.12.1	Potential Effects on Federal Agency Regulations

Federal agencies can play an important role in facilitating information collection, sharing information
with involved parties, and clearly communicating project milestones and deadlines during the Federal
licensing or permitting process. The final rule does not explicitly require other Federal agencies to
change their existing regulations to reflect the revised requirements in the final rule. For this reason, this
economic analysis does not attempt to quantify costs of regulatory updates for other Federal agencies.

As mentioned previously, the final rule includes conforming amendments to regulations for water
quality certifications on EPA-issued NPDES permits. These revisions will make the NPDES regulations
consistent with the approaches and impacts already discussed in this economic analysis. This economic
analysis does not attempt to differentiate the costs of regulatory updates for EPA's NPDES program from
the changes to the section 401 regulations.

4.12.2	Potential Effects on Certifying Authority Regulations and Guidance

Certifying authorities generally delineate their section 401 requirements in statutes, regulations,
guidance documents, and forms. The final rule does not require states or Tribes to update their

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regulations, statutes, guidance documents, or forms. CWA section 401 provides states and authorized
Tribes with the ability to grant (with or without conditions), deny, or waive certification for federally
licensed or permitted projects that may result in a discharge into waters of the United States. Unlike the
CWA section 402 and section 404 permitting programs, the CWA does not require EPA to approve state
administration of the section 401 program. The CWA also does not require states or authorized Tribes to
establish regulations to implement section 401, but many states and some authorized Tribes have
promulgated section 401 implementing regulations. Additionally, any changes made by a state or
authorized Tribe to their section 401 program do not require formal approval by EPA. In summary, with
this rulemaking, EPA is neither mandating that conforming changes be made to state or Tribal
regulations, nor overseeing in any capacity such changes. EPA is not aware to what extent states or
Tribes may update their requirements, so this document does not attempt to quantify potential costs
associated with states or Tribes doing so. The Agency recognizes that to increase certainty and clarity
and to avoid other negative outcomes, certifying authorities may update their section 401
requirements. As a result, states or authorized Tribes that have section 401 regulations, statutes,
guidance documents, and forms that are inconsistent with this final rule may incur costs to conform
their requirements to the final rule. However, the Agency does not expect that most certifying
authorities will need to update their requirements to conform with the final rule provisions. The costs to
certifying authorities for updating any requirements are expected to be minimal, due to the final rule
codifying longstanding practices and case law on section 401. As discussed below, some certifying
authorities may opt to modify their requirements for a request for certification, specify if and when pre-
filing meetings may occur, and alter fees associated with certifications. However, any costs associated
with such modifications will be incurred as a result of a certifying authority's own decision-making and
not required by the final rule.

Because certifying authorities delineate their requirements in different ways, EPA is unable to fully
describe all potential revisions states or Tribes may make or the associated costs. However, the
following paragraphs discuss potential changes states or Tribes may make in response to the final rule.
EPA reviewed select topics covered in state section 401 regulations that may differ from the final rule
provisions.

Some state section 401 regulations include language stating that the reasonable period of time begins
after the state receives a complete application or after the certifying authority determines that a
certification request is complete. Such language is not in conflict with the final rule provisions as long as
these states also clearly define the contents of a "request for certification." If a state does not clearly
define the contents of a certification request, then the final rule defines the contents for certification
requests that must be met before the reasonable period of time begins. The default list may not include
all contents that the certifying authority may otherwise want to consider during section 401 reviews.
States can rectify the situation by providing their own definition for a "request for certification" that
includes all contents that they want to consider.

Some state section 401 regulations recommend or encourage project proponents to request meetings
with the state certifying authority prior to the submittal of a certification request, and several certifying
authorities have updated their section 401 documentation to address the 2020 Rule requirement for
project proponents to request a pre-filing meeting. Similar to the 2020 Rule, the final rule requires
project proponents (including Federal agencies seeking to issue general licenses or permits) to request
pre-filing meetings before every certification request, unless the certifying authority waives the

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requirement (either universally or on a categorical basis). Even when a pre-filing meeting request is
required by the certifying authority, the certifying authority is not required to accept the pre-filing
meeting request. States may choose to update their regulations to specify that project proponents are
required to request a pre-filing meeting for all projects (if they have not already done so under the 2020
Rule) or specify which project types require a pre-filing meeting request. However, the final rule does
not establish the manner or method for certifying authorities to communicate whether it will hold pre-
filing meetings or waive them; as a result, some certifying authorities may opt to communicate such
approaches through less formal means than regulations (e.g., website updates, guidance forms).

States also have different fee structures for section 401 certifications. Some state section 401
regulations mention the existence of a fee but do not include specific language about the response to
nonpayment of the fees. Other states include language about nonpayment of applicable fees; for
example, regulations may specify that fees must be paid to produce a complete application and start the
review process, or that an application is considered withdrawn if the project proponent fails to pay the
appropriate fee within a specified time period. States may have addressed such language in response to
the 2020 Rule, which did not include fee payment as a required "request for certification" element. For
states that still have such language in their section 401 documentation, the language is not in conflict
with the final rule provisions if these states also provide their own definition or components for a
"request for certification" that include fee payment as a required element. The final rule definition for a
"request for certification," which applies when EPA is the certifying authority and when states or
authorized Tribes do not have their own "request for certification" definition, does not include fee
payment as a required component of certification requests. States with such conflicts can rectify the
discrepancy by providing their own definition for a "request for certification" that includes fee payment
as a required element.

4.13 Information Collection Request Burden Estimates

In accordance with the Paperwork Reduction Act, EPA has developed an ICR for the final rule. ICRs are
developed based on available information about how a regulation may affect a respondent. The total
annual burden for respondents, which includes project proponents, certifying authorities, and Tribes
applying for TAS, has decreased when compared to the estimates in the collection for the 2020 Rule, as
well as compared to the estimates in the collection for the 1971 Rule. According to the ICR, the total
annual burden is anticipated to be 861,274 hours (552,500 hours for certifying authorities, 308,000
hours for project proponents, 322 hours for tribes applying for TAS for section 401, and 452 hours for
Tribes applying for TAS for section 401(a)(2)) with associated annual labor costs being approximately
$48 million ($29 million for certifying authorities, $19 million for project proponents, and $25,850 for
Tribes applying for TAS for section 401, and $36,252 for Tribes applying for TAS for section 401(a)(2)).
These changes are mainly due to refinements in how the estimates are calculated, updated information
regarding the average annual number of licenses or permits issued, and updated information regarding
the annual number of certification requests rather than the Agency's ability to quantify differential
burden under the particular requirements of the final rule. Please see the Supporting Statement in the
docket for this rulemaking for further discussion on the estimates for this collection (OMB Control No.
2040-0295). The ICR estimates are based on overall burden of section 401, including changes associated
with this rule, and do not represent the incremental burden of the final rule.

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4.14 Summary of Potential Effects

Figure 4-1 presents a schematic diagram of the potential environmental benefits resulting from the final
rule, focusing primarily on the impacts from the change in scope of certification. The ultimate benefits
are expressed as values people hold for the expected environmental improvements. Reading the figures
from left to right, the specific action resulting from the final rule is described in increasing specificity,
first as ecological changes and effects, then as changes in ecosystem services. Benefit-relevant indicators
of water quality are the metrics that can be used to demonstrate the magnitude of environmental
benefits, and finally, the values people hold for ecosystem services are often measured in quantifiable
effects on the delivery of ecosystem services. The dashed line around the blue boxes in the fourth
column and the magenta boxes in the fifth column signal that the ecosystem services in the teal boxes in
the third column may be related to one or more of the metrics and values pairs.

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Figure 4-1. Incremental benefits of the final rulemaking

Ecological Changes and Effects

Valued Ecosystem Services and
Environmental Conditions

Benefit-relevant Indicators - Water
Quality

Measurable Values and Benefits

Certifying
authority issues a

certification
decision, which
may include more

water quality-
related conditions
when considering
the activity

Possible ecological changes
and effects depend on the
nature, size, location, and
type of projects that require
a Federal license or permit

Hydropower dam licenses may
include conditions that reduce
water quality impacts associated
with sedimentation, preserve or
restore aquatic habitats, allow fish
passage, prevent trash pollution,
and allow adapative management
in response to temperature or flow
monitoring and reporting

Large pipeline permits may include
construction-phase conditions that
reduce water quality impacts
associated with erosion,
sedimentation, and stormwater
runoff, and allow adapative
management in response to
temperature, flow, or aquatic
species impact monitoring and
reporting

Compliance with water
quality requirements (e.g.,
water quality standards, any
other water quality-related
requirement of state or
Tribal law)

Preservation or restoration
of aquatic habitats

Maintain biodiversity (i.e.,

maintain native species
sensitive to sedimentation)

Maintain health offish and
shellfish from reduced
ingestion of trash and
harmful pollutants

Maintain streamflow or
temperature to preserve
aquatic life populations

Reduce impacts on aquatic
habitat and aquatic life from
flashiness of streamflow

	

Frequency of water
quality standard
exceedances

Secchi depth

Species biodiversity

Presence, richness,
and abundance of
desirable fish species

Other indicators

Recreational use
values

Incremental property
value due to
proximate clear

Nonuse values

Willingness to pay for
recreational fishing

Other values and
benefits



Direct and indirect linkages

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4.14.1 Incremental Benefits

Overall, the final rule is anticipated to have positive environmental benefits, particularly incremental
water quality improvements resulting from efforts to standardize information included in requests for
certification (Section 4.3 above) and changes in scope of certification relative to the 2020 Rule (Section
4.5 above).

Society values such ecological improvements by a number of mechanisms, including increased
frequency and value of use of the improved surface waters for recreational and educational activities. In
addition, individuals also value the protection of habitats and species that would be adversely affected
by stream degradation from particular projects, even when those individuals do not use or anticipate
future use of the affected waterways for recreational or other purposes, resulting in nonuse values.49

Water-based recreational activities that will be enhanced by surface water quality improvements may
include swimming, recreational fishing, boating, and other outings. In each case, improved water quality
may increase water quality benefits in two ways: (1) an increase in the value of a recreational trip
resulting from a more enjoyable experience, and (2) an increase in the number of recreational trips.

Swimmers benefit from more sites suitable for swimming and enhanced experiences when waters are
safer for swimming with fewer pathogen-induced illnesses; reduced pollutant loadings are also likely to
increase the aesthetic appeal (i.e., clarity and lack of odor) and enjoyment. Anglers benefit from
improved fish populations and more waters being suitable as habitat (e.g., increased levels of dissolved
oxygen, allowing fish to breathe; improved fish passage at dams; temperatures staying in ranges suitable
to native species). Fish populations also improve from reduction in pollutants that inhibit reproduction,
growth, and survival of species (e.g., Mason, 2011; Kahn et al., 2014; Alkire et al., 2020), which may also
increase species diversity. Improved aesthetic qualities also enhance fishing recreation. Boaters may
benefit from reductions in secondary-contact illnesses and improved aesthetics leading to a better
recreational experience. Boaters also benefit from better opportunities for companion activities, such as
swimming, fishing, and wildlife viewing. Other outings include recreational activities such as hiking,
jogging, picnicking, and wildlife viewing; these activities are enhanced by better aesthetic experiences
and more opportunities to view wildlife, whether aquatic, terrestrial or avian (e.g., piscivorous birds,
such as osprey and eagles), that result from water quality improvements and improved fish populations.
Water quality improvements improve wildlife diversity since excessive nutrient loadings can lead to
eutrophic and turbid waters with few plants, invertebrate, and fish food sources for waterfowl and
other wildlife (MDNR, 2010).

In addition to recreation benefits, water quality improvements resulting from the final rulemaking may
also have property value benefits. Numerous economic studies (e.g., Leggett et al., 2000; Bin et al.,
2013; P. J. Walsh et al., 2011; Tuttle et al., 2015; Klemick et al., 2018; Kung et al., 2022) suggest that
waterfront property is more desirable when located near unpolluted water. Some previously published
hedonic property studies (e.g., P. J. Walsh et al., 2011; Netusil et al., 2014; Liu et al., 2017; Klemick et al.,

49 Observed data on use behavior can be analyzed to assess use values (e.g., travel cost models for water-based
recreation), but nonuse values do not have corresponding observable behavior. In analyzing benefits associated
with water quality improvements, EPA has in the past used a regression-based meta-analysis of 189 estimates of
total willingness to pay (including both use and nonuse values) for water quality improvements, provided by 59
original studies (U.S. EPA (2020a)).

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2018) found that the property value premium for increased water quality also extends to homes up to
one kilometer from the water. EPA was not able to quantify or monetize the potential increase in
property values associated with the environmental benefits expected to result from the final rule. The
magnitude of the potential increase depends on many factors, including the number and context of
future section 401 certification cases whose outcomes might be affected by this rule, the number of
housing units located near the waterbodies in question, and other factors.

The total benefits of an environmental improvement are the combination of use and nonuse benefits
(Freeman III, 1993; Freeman III, 2014).50 Recent economic literature provides substantial empirical
support that nonuse values, such as option and existence values, are greater than zero. In fact, small per
capita nonuse values held by a substantial fraction of the population can be very large in the aggregate.
Consequently, both EPA's own Guidelines for Preparing Economic Analysis and the Office of
Management and Budget's (OMB) Circular A-4 governing regulatory analysis support the need to assess
nonuse values (U.S. EPA, 2010; U.S. OMB, 2003).

Although EPA is not always able to estimate changes in nonuse values as part of regulatory
development, an extensive body of environmental economics literature demonstrates that the public
holds significant value for services flowing from natural resources well beyond those associated with
direct uses (Boyd et al., 2001; Fischman, 2001; Heal et al., 2001; Herman et al., 2001; Ruhl and Gregg,
2001; Salzman et al., 2001; Wainger et al., 2001). Studies have documented public values for services
provided by a variety of natural resources potentially affected by the final rule, including fish and wildlife
(Loomis et al., 2000; Stevens et al., 1991); wetlands (Woodward and Wui, 2001); wilderness (Walsh et
al., 1984); critical habitat for threatened and endangered species (Haqen etal., 1992; Loomis and
Ekstrand 1997; Whitehead and Blomquist 1991); shoreline quality (Grigalunas et al., 1988); and beaches,
shorebirds, and marine mammals (Rowe et al. 1992), among others. Many ecosystems provide goods
and services that contribute to societal well-being but may be generally unrecognized because of the
indirect nature of the effect. As such, valuations based solely on the analysis of markets are unlikely to
capture the full economic value of the affected ecosystem services. For example, stream improvements
will create recreational opportunities, increase commercial activity in the affected neighborhoods, and
improve community wellbeing.

4.14.2 Incremental Costs

Overall cost impacts are uncertain. While some provisions are expected to lead to cost savings for both
certifying authorities and project proponents (e.g., request for certification, EPA's roles under section
401), other provisions have uncertain overall cost impacts for certain stakeholders (e.g., pre-filing
meeting requests for project proponents, reasonable period of time for Federal agencies) or incremental
costs (e.g., scope of certification, neighboring jurisdictions process). By promoting efficiency and
certainty in the certification process, the final rule will standardize the certification process, reduce
confusion, and promote efficient section 401 reviews. However, if the scope of the certification changes
relative to practice under the 2020 Rule, the final rule may result in incremental costs.

Section 4.13 presents ICR burden estimates, including cost estimates. However, the estimates are based
on overall burden of section 401, not the incremental burden of the final rule. The ICR includes some

50 This additive property holds under traditional conditions related to resource levels and prices for substitute
goods in the household production model (Freeman III, 1993).

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assessment of how burden is expected to change under the final rule relative to the 2020 Rule baseline.
For example, EPA expects that the hourly burden of the final rule to project proponents, on average, will
be similar to that under the 2020 Rule for several reasons. First, the final rule includes similar levels of
requirements as the 2020 Rule with some added flexibility. With certifying authorities having the ability
to waive or shorten the pre-filing meeting request requirement and define contents of requests for
certification, changes in burden from the 2020 Rule will depend on certifying authorities use of the final
rule flexibilities. Therefore, the final rule may or may not result in an incremental burden reduction
relative to the 2020 Rule. Second, the minimum contents in a request for certification should be readily
available and already developed as part of the license or permit application process.

4.14.3 Net Benefits

Table 4-1 summarizes the expected benefits and costs from individual rule provisions. The net benefits
expected from each provision—and from the rule as a whole—are uncertain given uncertainty about the
magnitude of expected environmental benefits, cost savings, and incremental costs (see additional
discussion in Section 6). EPA emphasizes that Table 4-1 is meant to present aggregate effects of rule
provisions across all section 401 reviews. EPA anticipates variation in rulemaking effects for singular
section 401 reviews, particularly across individual rule provisions. For example, projects that more
clearly trigger the neighboring jurisdictions process under the final rule may have incremental costs that
override cost savings under other final rule provisions. However, when considering the full universe of
section 401 reviews, EPA expects positive environmental benefits and cost savings for most rulemaking
provisions and for the overall rulemaking.

Table 4-1 presents a summary of potential effects relative to both the 1971 Rule and 2020 Rule
baselines. In the "environmental benefits" columns, positive effects correspond to environmental
improvements. EPA differentiates between environmental benefits that are "positive" and "positive but
small," the latter signaling where benefits are expected to be de minimis (e.g., small environmental
benefits from improvements in the section 401 review process due to increased clarity regarding when
section 401 certification is required). In the "process costs" columns, "incremental costs" correspond to
additional costs, while "cost savings" correspond to net cost reductions.

As mentioned above, "environmental benefit" and "process cost" determinations in Table 4-1 represent
aggregate effects of rule provisions. For example, changes to the pre-filing meeting request provision
may lead to cost savings for certifying authorities relative to both the 2020 Rule and 1971 Rule
baselines. Relative to the 2020 Rule, the provision allows certifying authorities to waive the 30-day
waiting period after receiving a pre-filing meeting request, which will reduce delay when pre-filing
meetings are not needed for a particular project. Relative to the 1971 Rule, which does not include a
pre-filing meeting component, certifying authorities are expected to only accept pre-filing meeting
requests when such meetings will be beneficial for their section 401 review (i.e., if the additional time
burden of the pre-filing meeting is more than offset by the time savings from a more efficient section
401 certification review process), such as in the case of large and complex projects. To illustrate the
potential magnitude of cost savings from changes to the pre-filing meeting provision under the 1971
Rule baseline, assume that certifying authorities save one business day of time (i.e., 8 hours) during the
certification review process by participating in a pre-filing meeting, and assume that certifying
authorities accept the pre-filing meeting request for all individual licenses or permits since individual
licenses or permits are typically required for more complex projects. If 3,500 individual licenses or
permits are reviewed annually (see Table 3-7), the total time savings for certifying authorities from pre-

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filing meetings would be 28,000 hours. Assuming hourly wages are at least $36, the cost savings would
be on the order of millions of dollars but not on the order of tens of millions of dollars. However,
relative to the 1971 Rule baseline, pre-filing meeting process costs are uncertain for project proponents
because cost savings resulting from improved efficiencies in the certification process may not exceed
burden of submitting pre-filing requests, participating in pre-filing meetings when accepted, and
potential fees that certifying authorities may charge for the pre-filing meetings.

Table 4-1. Summary of potential effects of the final rule, relative to the 1971 Rule and 2020 Rule baselines

Provision

1971 Rule Baseline

2020 Rule Baseline

Environmental
Benefits

Process Costs

Environmental
Benefits

Process Costs

When Section 401
Certification is
Required

Positive but small

Cost savings (but
small) for CAs, PPs,
and FAs

NA

NA

Pre-filing Meeting
Request

Positive

Cost savings for
CAs; uncertain for
PPs

NA

Cost savings for CAs
and PPs

Request for
Certification

Positive

Cost savings for
CAs and PPs

Positive

Cost savings for CAs
and PPs

Reasonable Period
of Time

Positive but small

Cost savings for
CAs and PPs;
incremental costs
for FAs

Positive but small

Cost savings for CAs,
PPs, FAs

Scope of
Certification

Positive but small

Uncertain cost
impacts for CAs;
incremental costs
(but small) for PPs

Positive

Incremental costs
for CAs and PPs

Certification
Decisions

Positive

Cost savings for
CAs and PPs (but
small)

Positive

Cost savings for CAs
and PPs

Federal Agency
Review

Positive

Uncertain cost
impacts for CAs
and PPs

Positive

Incremental costs
for PPs

EPA Roles under
Section 401

Positive but small

Cost savings for
CAs, PPs, and EPA

Positive but small

Cost savings for
EPA; uncertain for
PPs

Modifications

Negligible

Cost savings for
CAs, PPs, and FAs

Positive

Cost savings for CAs,
PPs, and FAs

Neighboring
Jurisdictions
Process

Positive

Incremental costs
for PPs

Positive

Incremental costs
for PPs

TAS and Other
Tribal Issues

Positive

Uncertain cost
impacts for PPs

Positive

Uncertain cost
impacts for PPs

Notes: CA = certifying authority; PP = project proponent; FA = Federal agency

5 Environmental Justice

Executive Order (EO) 12898 directs agencies to make environmental justice (EJ) 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. Moreover, EO 12898 provides that each Federal agency must conduct its programs,

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policies, and activities that substantially affect human health or the environment in a manner that
ensures such programs, policies, and activities do not have the effect of (1) excluding persons or
populations from participation in, or (2) denying persons or populations the benefits of, or (3) subjecting
persons or populations to discrimination under such programs, policies, and activities because of their
race, color, or national origin.

EO 14008 expands on the policy objectives established in EO 12898 and directs 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.

EO 14096 expands on the policy objectives of EO 12898 and EO 14008 by further embedding
environmental justice for all through a whole-of-government 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.

Other recent executive actions that touch on environmental justice include EO 13985, EO 13990, and EO
13653. EPA also published "Technical Guidance for Assessing Environmental Justice in Regulatory
Analysis" (U.S. EPA, 2016) to provide recommendations that encourage analysts to conduct the highest
quality analysis feasible, recognizing that data limitations, time and resource constraints, and analytic
challenges will vary by media and circumstance.

For the final rule, the Agency qualitatively assessed whether the change in benefits from the rulemaking
may be differentially distributed among communities with environmental justice concerns. The Agency
determined that the final rule may have some positive impacts for communities with environmental
justice concerns, which may include Tribal communities. Such impacts are explored in Sections 5.1 and
5.2 below.

5.1 Impacts on Communities with Environmental Justice Concerns

Several revisions in this rulemaking may give communities with environmental justice concerns greater
autonomy and influence over the quality of waters in their area. This section outlines the positive
impacts to these communities that may result from several final rule provisions: (1) pre-filing meeting
requests; (2) request for certification; (3) reasonable period of time; (4) scope of certification; (5)

Federal agency review; (6) EPA's roles under section 401; (7) modifications; and (8) neighboring
jurisdictions process.

Pre-filing meetings may provide certifying authorities with an early opportunity to request and receive
project details, allowing for better informed certification decisions that may affect communities with
environmental justice concerns. Thus, the pre-filing meetings provision of the final rule may have
positive environmental justice (EJ) effects relative to the 1971 Rule baseline. Since the 2020 Rule
included a pre-filing meeting requirement, the pre-filing meeting provision of the final rule is unlikely to
have any EJ-related effects relative to the 2020 Rule baseline.

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By explicitly providing that certifying authorities can define the contents of a request for certification,
the final rule ensures that states and authorized Tribes have the information they need to complete
their review of the request as it relates to protecting their water quality. Additionally, by requiring
minimum contents for all requests for certification, the Agency provides safeguards for certifying
authorities that have not defined contents of a request for certification. Efforts to standardize
information included in certification requests may improve the quality of section 401 reviews, which
may translate to water quality improvements near communities with environmental justice concerns.

The collaborative approach for the reasonable period of time determination provides certifying
authorities with negotiation power. The certifying authority can take the needs of communities into
account when trying to determine the length of time needed to review and evaluate the potential
impacts of the proposed project on the communities' water resources. The six-month default
reasonable period of time, if there is no agreement between the Federal agency and certifying authority,
balances the bargaining power of both parties.

The revision to set the scope of certification review to the "activity" can also provide positive impacts on
communities with EJ concerns. This approach gives certifying authorities serving communities with
environmental justice concerns a broader scope of review to address water quality-related impacts to
their water resources. Under the 2020 Rule, the scope of review was limited to assuring that any
discharge from the project (as opposed to the "activity") would comply with water quality requirements.
Additionally, the 2020 Rule limited water quality requirements to Federal, state, and Tribal laws
regulating point source discharges. By contrast, the final rule allows certifying authorities to evaluate the
"water quality-related impacts from the activity subject to the license or permit, including the activity's
construction and operation." 40 CFR 121.3(a).

Communities with environmental justice concerns will also benefit from the final rule's considerations
for Federal agency review. Relative to the 2020 Rule, the final rule limits the scope of Federal agency
review to three facial statutory components of section 401. It also eliminates the possibility of
constructive waiver of a certification decision with conditions designed to protect these communities
from negative water quality impacts for failure to comply with the informational requirements set out in
the 2020 Rule. Under the final rule, constructive waivers only occur if the certifying authority fails to act
within the reasonable period of time.

The provisions regarding EPA's roles under section 401 may also benefit communities with
environmental justice concerns. Updating the public notice procedures and defining a timeframe for
public notice when EPA acts as the certifying authority will provide more certainty to the public
regarding when public comment occurs and may improve community engagement. Broadening the
scope of EPA's technical assistance provides more support to stakeholders in the certification process,
including certifying authorities. Since the 2020 Rule broadened the scope of EPA's technical assistance,
the final rule provisions related to technical assistance are unlikely to have any EJ effects relative to the
2020 Rule baseline.

Retaining the modifications provision can also have positive impacts on communities with
environmental justice concerns since the public can inform the certifying authority and the Federal
agency when circumstances warranting certification modification arise. Allowing certification
modifications, and therefore project modifications, reduces the potential of environmental degradation
in these communities and has further positive impacts on water quality. This provision will also allow

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certifying authorities to consider potential environmental degradation and impacts to communities of
concern that can result from project/license/permit adjustments. However, the provision's stipulation
that the certifying authority and Federal agency must agree on proposed certification modifications can
limit the ability of certifying authorities to make desired changes should the Federal agency disagree
that a modification to the certification is appropriate. The 2020 Rule removed the modification provision
and instead relied on other Federal agency regulations to address modifications. Using the 2020 Rule as
a baseline, the final rule will have substantial benefits, as listed above, by allowing certifying authorities
and Federal agencies to agree to modify a grant of certification. Relative to 1971 Rule baseline, the final
rule provision adds clarification regarding the allowable scope and extent of modifications. The
increased clarity relative to the 1971 Rule baseline can improve the modification process and make
certifying authorities and Federal agencies more likely to agree to modify a certification under changing
project conditions.

Revisions to the neighboring jurisdiction provision will allow other affected communities to provide
input on section 401 certifications. EPA's revisions to clarify the objection and hearing process may allow
neighboring jurisdictions with communities with environmental justice concerns to better participate in
the section 401 process. The final rule clarifies the neighboring jurisdictions process and can reduce
harms to communities with EJ concern located near waters affected by a proposed project in a
neighboring jurisdiction. Relative to the 2020 Rule, which gave EPA discretion regarding whether to
make a "may affect" determination for neighboring jurisdictions, the final rule will ensure that EPA
always assesses potential impacts to neighboring jurisdictions and makes a "may affect" determination.
Ensuring that EPA makes a "may affect" determination will increase the potential for neighboring
jurisdictions to protect communities with environmental justice concerns from negative water quality
impacts originating in other jurisdictions.

5.2 Tribal Impacts

A few aspects of the final rulemaking will provide clarity and greater flexibility for Tribal governments to
manage water quality in their jurisdictions. The provisions of the rulemaking relevant to Tribes include:
(1) scope of certification; (2) Federal agency review; (3) EPA's roles under section 401; (4) modifications;
(5) neighboring jurisdictions process; and (6) TAS and other Tribal issues.

Clarifications that the scope of certification includes effects from the "activity" will allow Tribal
governments with TAS and those without TAS for which EPA acts as the certifying authority to have
greater autonomy and control to ensure that Federal projects affecting waters in their jurisdiction meet
all applicable water quality requirements, including water quality-related religious, economic, and/or
cultural requirements. Other Tribal and non-Tribal stakeholders stated in pre-proposal input that it is
critical to allow certifying authorities the ability to evaluate proposed activities beyond point source
discharges to preserve water quality requirements specific to their respective jurisdictions. Some
commenters from the public comment period asserted that a broader scope of review was necessary for
certifying authorities to hoiistically and effectively protect their water quality. While this provision has
been practiced historically based on case law under the 1971 baseline, adding clarity in the final rule
may protect Tribal certifying authorities from legal disputes. Under the 2020 Rule, the scope of review
was limited to assuring that any discharge from a Federal project would comply with water quality
requirements as opposed to the activity. Additionally, the 2020 Rule limited water quality requirements
to Federal, state, and Tribal laws regulating point source discharges. The final rule allows Tribal

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governments to evaluate all aspects of a project that can impact compliance with their water quality
requirements.

Tribal communities can also benefit from the final rule's considerations for Federal agency review.
Relative to the 2020 Rule, the final rule limits the scope of Federal agency review to three facial
statutory components of section 401 and eliminates the possibility of a constructive waiver of a Tribal
certification for failure to comply with the informational requirements set out in the 2020 Rule.

When EPA acts as a certifying authority on behalf of Tribal governments, the Agency provides public
notice on any requests for certification. The revisions to the public notice provision when EPA is a
certifying authority are expected to provide more clarity to Tribal communities regarding when to
provide input on a project in the section 401 certification process.51 This provision of the rulemaking can
give Tribal members greater involvement with local water quality when they are not the certifying
authority because the public notice will be provided in a timely manner. Tribal governments and
members can also utilize the expanded scope of EPA's technical assistance (relative to the 1971 Rule
baseline) to learn more about water quality requirements or methods to comply with applicable water
quality requirements.

Allowing for a certification modification when the Federal agency and the certifying authority agree will
respect state and Tribal rights and promote cooperative federalism. Commenters from the public
comment period added that the ability to modify certification conditions is vital for certifying authorities
to protect their water quality. Should conditions in waters of importance to over-burdened and/or
under-served communities or Tribal communities change during the licensing or permitting period, a
certification modification will allow these communities more flexibility to address the changing
conditions. In pre-proposal input letters, stakeholders asserted that certifying authorities are in the best
position to determine whether a certification modification is required. Reintroducing the collaborative
process from the 1971 Rule stipulating that the Federal agency must agree with the certifying authority
prior to the certifying authority modifying the certification can limit a Tribal government's authority if
the Federal agency disagrees. The 2020 Rule removed the modification provision and instead relied on
other Federal agency regulations to address modifications. Using the 2020 Rule as a baseline, the final
rule will have substantial benefits, as listed above, by allowing certifying authorities and Federal
agencies to agree to modify a grant of certification as appropriate if project conditions change.

Revisions to the neighboring jurisdictions and TAS provisions can have substantive positive impacts on
Tribal communities. Clarifications regarding when neighboring jurisdiction assessments are required will
standardize the neighboring jurisdiction assessment process and ensure that Tribal governments with
TAS (either for section 401 as a whole or just section 401(a)(2)) have the opportunity to provide input if
EPA determines that a discharge originating from a neighboring jurisdiction may affect their water
quality. The final rule provision to develop separate TAS provisions for section 401, rather than requiring
TAS for section 303(c) to obtain TAS for section 401, provides Tribal governments with more options in
their decision to seek TAS. Increased Tribal section 401 authority will allow Tribal governments to gain
autonomy in maintaining water quality requirements in Tribal waters. Additionally, a separate TAS

51 Of note, each EPA regional office has also developed Regional Consultation Procedures in line with EPA's Policy
on Consultation and Coordination with Indian Tribes. These guidance documents describe the specific consultation
practices of each EPA region and what activities are appropriate for consultation.

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provision for section 401(a)(2) will allow Tribal governments that do not wish to take on the entire
section 401 program to be notified and participate in the neighboring jurisdictions process when EPA
determines that its waters may be affected by a discharge.

6 Data Limitations and Uncertainty

Table 6-1 summarizes the limitations and uncertainties that EPA faced in assessing the potential impacts
arising from the final rule, which necessitated the use of qualitative rather than quantitative analysis.
This section focuses on limitations and uncertainties from the overall analysis rather than specific rule
provisions. Whether these limitations and uncertainties, taken together, are likely to result in an
understatement or overstatement of the potential impacts is not known.

Table 6-1. Limitations and uncertainties in estimating effects of final rule

Uncertainty/Data Limitation

Notes

Lack of a national-level dataset of
section 401 certification reviews

The lack of a national-level dataset of section 401 water quality certification
reviews limited EPA's ability to perform a quantitative analysis of the
potential impacts of the final rule in this economic analysis. EPA has limited
data regarding the number of section 401 reviews that each certifying
authority conducts annually, the number of certification actions (grant,
grant with conditions, deny, or waive), average time spent per review, and
other time requirements. For the final rule, EPA attempted to increase
available data via machine reading of PDFs of section 401 certification
decisions, but this effort was subject to significant limitations and did not
generate data of a quality sufficient to pass EPA's quality assurance
standards (see Section 3.2.5 above). For detailed discussion on the
certification decision machine reading effort, please see the Certification
Decision PDF Extraction Memo, available in the docket for this rulemaking.
Additionally, the code and outputs for this effort are publicly accessible and
can be found in the docket for this rulemaking.

Uncertainty regarding the
baseline for the final rule

Due to ongoing litigation on the 2020 Rule, the baseline for the final rule
has changed from the 1971 Rule to the 2020 Rule and remains uncertain.
See Section III.C of the final rule preamble for further discussion on ongoing
litigation on the 2020 Rule. This baseline uncertainty required assessing
final rule impacts relative to both the 1971 Rule and the 2020 Rule.

Lack of information to determine
how certifying authorities will
respond to the final rule (e.g., fee
changes, acceptance rate of pre-
filing meeting request
requirement)

The impact of the final rule on both certifying authorities and project
proponents could vary depending on certifying authority response. For
example, certifying authorities may adjust their fee structure for section
401 reviews to account for changing costs or keep their fee structure (or
lack thereof) the same. In another example, the impact of the pre-filing
meeting request requirement depends on whether the certifying authority
currently engages in pre-filing meetings, whether the certifying authority
will require pre-filing meeting requests for all projects, how frequently the
certifying authority may accept the meeting request (if at all), the
methodology used to conduct pre-filing meetings, and whether the
certifying authority implements a pre-filing meeting fee to help cover costs.
See Section 4.2.2.2 for additional details.

Lack of information to determine
how often the 6-month
reasonable period of time is in
effect and how often the
reasonable period of time is

The final rule requires certifying authorities and Federal agencies to set the
reasonable period of time collaboratively, with a six-month default
reasonable period of time if an agreement cannot be reached and if none
of the auto-extension conditions apply. Auto-extensions apply when
certifying authorities have public notice procedures that make meeting a

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Table 6-1. Limitations and uncertainties in estimating effects of final rule

Uncertainty/Data Limitation

Notes

exceeded for reasons covered by
the auto-extension process

six-month reasonable period of time impossible, or when there are force
majeure events (e.g., Federal government closures, natural disasters).
Quantifying the impacts of this provision would require data about how
often the six-month default reasonable period of time would be in effect
and how often the auto-extension conditions would apply.

Lack of information to determine
change in certification denials

With the reasonable period of time starting after receipt of a request for
certification, certifying authorities may deny certification if they do not
receive additional information that they assert is needed to make a
determination. The actual change resulting from the final rule is uncertain
since pre-filing meetings and revisions to standardize information included
in requests for certification will likely increase the initial availability of
information that may be necessary to make a certification decision.

Lack of information to determine
impacts of Federal agency review

The final rule defines three facial statutory aspects of a certification
decision that are subject to Federal agency review. Quantifying the impacts
of this provision would require data regarding the frequency of: (1)
challenges to certification decisions, and (2) challenged certifications not
complying with the three facial statutory aspects.

Lack of information about the
number of Tribes interested in
obtaining TAS for section 401 and
401(a)(2) alone

The final rule provides a pathway for Tribal governments to apply directly
for TAS for section 401 or 401(a)(2), rather than obtaining section 401
authority by applying for TAS for section 303(c). Quantifying the impacts of
this provision would require information about the number of Tribal
governments interested in obtaining TAS for section 401 or 401(a)(2) alone
rather than TAS for both sections 303(c) and 401.

Lack of information to assess the
combined effect of final rule
provisions

EPA anticipates that, overall, the final rule will result in more predictable,
efficient decision-making by certifying authorities as compared with both
the 2020 Rule and 1971 Rule baselines. Quantifying the combined effect of
the final rule on certifying authorities, project proponents, and other
stakeholders would require quantifying and adding together the effects of
individual provisions.

7 Statutory and Executive Order Requirements

The statutory requirements considered during development of the final rule include the Regulatory
Flexibility Act (RFA) and Small Business Regulatory Enforcement Fairness Act (SBREFA), the Paperwork
Reduction Act, the Unfunded Mandate Reform Act, and the National Technology Transfer and
Advancement Act (NTTAA). The analysis is also conducted pursuant to Executive Orders 12866
(Regulatory Planning and Review), 12898 (Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations), 13132 (Federalism), 13175 (Consultation and Coordination
with Indian Tribal Governments), 13045 (Protection of Children from Environmental Health Risks and
Safety Risks), 13211 (Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use), 14008 (Revitalizing Our Nation's Commitment to Environmental Justice for All),
and 14094 (Modernizing Regulatory Review). Requirements with specific import for an economic and
programmatic analysis are described in the sections below; others are addressed in the preamble to the
final rule. Some are addressed in both documents.

7.1 Unfunded Mandate Reform Act

The Unfunded Mandate Reform Act (UMRA) contains requirements for agencies when regulations
include unfunded Federal mandates imposed by the Federal government on state, local, and Tribal

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governments. For reasons noted previously, EPA does not have comprehensive data with which to
analyze fully the costs of the final rule and therefore conducted a qualitative analysis of the rule relative
to the UMRA threshold. The requirement of the final rule that most lends itself to cost analysis is the
pre-filing meeting request, which was included in the 2020 Rule. Rough estimates of wage rates and
labor hours associated with the pre-filing meeting request and meeting suggest costs on the order of
several thousand dollars at the upper end. However, unlike the 2020 Rule, the final rule only requires
the project proponent to request a pre-filing meeting if a certifying authority does not otherwise waive
the requirement. The final rule allows the certifying authority to waive the meeting requirement or
shorten the wait time between requesting a pre-filing meeting and requesting certification. EPA also
notes that Table 3-7 shows that about 94 percent of Federal licenses or permits are general licenses or
permits, which apply when specific conditions are known to apply to the project, such as limitations on
the acreage of the project. Many general licenses or permits receive certification for issuance, so project
proponents seeking authorization under a general license or permit will only be subject to the pre-filing
meeting request requirement if the certification was denied. In those instances, EPA assumes that
certifying authorities may use the known conditions of the general license or permit as a rationale for
waiving the pre-filing meeting. Based on these assumptions, EPA anticipates a rough cost estimate of
the pre-filing meeting request requirement burden measured in a few tens of millions of dollars. EPA
expects that some licenses or permits can have higher costs due to other provisions of the final rule, but
also expects those costs to be measured in tens or hundreds of thousands of dollars and the number of
such licenses and permits to be a small fraction of those subject to requesting the pre-filing meeting. In
the aggregate, EPA expects the costs of this rule to be well below $160 million, the UMRA threshold of
$100 million adjusted for inflation to 2021 dollars using the GDP implicit price deflator. Therefore, this
action does not contain an unfunded mandate exceeding the UMRA threshold 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. If a state chooses to
participate in the section 401 process, and by choosing to do so may be subject to some requirements in
the rule, that choice does not rise to the level of "enforceable duty" under the statute.

7.2 Executive Order 12898 Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations; Executive Order 14096:
Revitalizing Our Nation's Commitment to Environmental Justice for All

EO 12898 requires Federal agencies to identify and address the disproportionately high and adverse
human health or environmental effects of their actions on minority and low-income populations, to the
greatest extent practicable and permitted by law. EO 14096 directs 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. The Agency has conducted an environmental justice analysis for the final rule to qualitatively
assess whether the change in benefits from the rulemaking may be differentially distributed among
communities with environmental justice concerns The Agency determined that the final rule may have
some positive impacts for communities with environmental justice concerns, which may include Tribal
communities. See Section 5 of this economic analysis for further discussion.

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7.3	Executive Orders 12866 Regulatory Planning and Review and 14094
Modernizing Regulatory Review

EPA anticipates that the final rule will have varying effects on certifying authorities, project proponents,
and Federal agencies. However, the Agency is unable to fully quantify the impacts of the final rule due to
several data limitations and uncertainties, which are described in Section 6 of this document. Due to the
limitations, any attempts to quantify the benefits and costs of the final rule provisions would be highly
speculative and imprecise. Therefore, EPA included a qualitative assessment of the potential impacts of
the final rule on project proponents, certifying authorities, and Federal agencies in this economic
analysis.

EPA acknowledges that there will likely be some costs associated with project proponents, certifying
authorities, and Federal agencies reviewing the final rule language and ensuring that their activities
going forward comply with the final rule.

7.4	Regulatory Flexibility Act and Small Business Regulatory Enforcement
Fairness Act

EPA expects that the final rule will improve coordination between project proponents, certifying
authorities, and Federal agencies, which will in turn reduce regulatory uncertainty and project delays for
project proponents, including small entities. The small entities subject to the requirements of this action
are small businesses applying for Federal licenses or permits subject to section 401 certification, which
could include construction, manufacturing, mining, and utility businesses.52 Based on the qualitative
analysis, the Agency has determined that some small entities may experience some impact from the
final rule but that the impact would not be significant. This final rule may impact states and authorized
Tribes that implement section 401 in the form of administrative burden and cost. States and Tribal
governments are not small entities under the RFA.

There are five provisions from the final rule that may have some impact on project proponents (as
mentioned above, these are the impacts that would apply to small entities): (1) the pre-filing meeting
request requirement; (2) the contents of a request for certification; (3) the scope of certification; (4)
modifications; and (5) the section 401(a)(2) review process. A qualitative summary of these anticipated
impacts on small entities as compared to the 1971 Rule and 2020 Rule baselines is discussed below.

7.4.1 Final Rule Provisions that May Have Some Impact on Project Proponents
First, the Agency is retaining the requirement for project proponents to request a pre-filing meeting
from the 2020 Rule; the 1971 Rule did not include a pre-filing meeting request requirement. However,
specific to the final rule provision, the certifying authority may waive the requirement for a pre-filing
meeting request. In pre-proposal input, several project proponents noted that while pre-filing meetings
had some utility, they had also resulted in delays in some instances and recommended that the Agency
provide greater flexibility for the pre-filing meeting request requirement, including allowing for waivers
or shortening the period between submitting a pre-filing meeting request and a request for

52 During the development of this final rule, the Agency considered public comment letters from various
stakeholders whose membership included small entities from these sectors. See, e.g., Mississippi Manufacturers
Association (EPA-HQ-OW-2022-0128-0152); Petroleum Association of Wyoming (EPA-HQ-OW-2022-0128-0160);
Tennessee Chamber of Commerce and Industry (EPA-HQ-OW-0128-0129).

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certification.53 Project proponents during the public comment period reiterated the value and potential
of pre-filing meetings to streamline the certification process, and they supported the early engagement
provision with flexibility for certifying authorities to waive or shorten the requirement.54 The final rule
provision provides certifying authorities with the flexibility to determine whether a pre-filing meeting
request is needed and allows certifying authorities to shorten the waiting period between submitting a
pre-filing meeting request and a request for certification. As a result, there are no additional
requirements being imposed upon project proponents, including small entities, with respect to this
aspect of the final rule when compared to the 2020 Rule baseline. Although the pre-filing meeting
request requirement is new when compared to the 1971 Rule baseline, the pre-filing meeting process
will ultimately reduce burden elsewhere in the section 401 certification process (e.g., reduce project
delays due to incomplete requests for certification). Certifying authorities may be more likely to waive
the pre-filing meeting request requirement for small, routine projects,55 which are more likely to involve
small entities. Therefore, the Agency expects the changes to the pre-filing meeting requirement to be a
reduction of direct economic impact on project proponents when the certifying authority determines
that both a pre-filing meeting request and a pre-filing meeting are not necessary prior to the submission
of a request for certification.56

Second, the Agency is updating the 2020 Rule provision describing the contents of a request for
certification for all certifying authorities; the 1971 Rule only described the contents of a request for
certification when EPA acted as the certifying authority. In pre-proposal input and public comment,
several project proponents noted that it was important to have clarity and predictability regarding the
elements of a request for certification and expressed support for the 2020 Rule's uniform requirements
for all certification requests.57 In public comment, several project proponents expressed concern over
project delays and workload due to the proposed inclusion of a copy of the draft license or permit and
any existing and readily available data in all requests for certification.58 Several project proponents also
generally supported the Agency's proposed alternative approach to include the application with a
request for certification on an individual license or permit, as opposed to the draft license or permit,

53	See, e.g., Association of American Railroads (EPA-HQ-OW-2021-0302-0021), Metallurgical Coal Producers
Association (EPA-HQ-OW-2021-0302-0036), MJB&A Permitting and Infrastructure Coalition (EPA-HQ-OW-2021-
0302-0064), Alaska Oil and Gas Association (EPA-HQ-OW-2021-0302-0090).

54	See, e.g., Interstate Natural Gas Association of America (EPA-HQ-OW-2022-0128-0122), Alaska Oil and Gas
Association (EPA-HQ-OW-2022-0128-0136), American Exploration & Mining Association (EPA-HQ-OW-2022-0128-
0147).

55	See, e.g., Natural Gas Supply Association (EPA-HQ-OW-2022-0128-0185), Washington Department of Ecology
(EPA-HQ-OW-2021-0302-0025), Utah Department of Environmental Quality (EPA-HQ-OW-2021-0302-0028), D.C.
Department of Energy and Environment (EPA-HQ-OW-2021-0302-0035).

56	See Section 4.2.2 for further discussion on the potential impacts of the provision from the 1971 Rule and 2020
Rule baselines.

57	See, e.g., Edison Electric Institute (EPA-HQ-OW-2021-0302-0049), GPA Midstream Association (EPA-HQ-OW-
2021-0302-0050), Natural Gas Supply Association (EPA-HQ-OW-2021-0302-0074), Williams Company (EPA-HQ-
OW-2021-0302-0084), Alaska Oil and Gas Association (EPA-HQ-OW-2022-0128-0136), J.R. Simplot Company (EPA-
HQ-OW-2022-0128-0268), Mississippi Manufacturers Association (EPA-HQ-OW-2022-0128-0152), Williams
Company (EPA-HQ-OW-2022-0128-0137).

58	See, e.g., Cross Cutting Issues Group (EPA-HQ-OW-2022-0128-0171), Mississippi Manufacturers Association
(EPA-HQ-OW-2022-0128-0152), Natural Gas Supply Association (EPA-HQ-OW-2022-0185).

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including one commenter who asserted that this alternative would significantly reduce the timeframe
within which a project proponent can receive all necessary permits.59 As discussed further below, the
Agency has revised the proposed approach to support a clear, predictable certification process. The
Agency anticipates that this provision includes direct impacts to small entities regarding the contents of
a request for certification. Specifically, in contrast to the 1971 Rule and 2020 Rule, when a project
proponent submits a request for certification to any certifying authority, the final rule bifurcates the
minimum content requirements for an individual license or permit and for the issuance of a general
license or permit. 40 CFR 121.5(a). 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 quality-related materials that informed the
development of the application. However, 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. The final rule also provides a standardized list of
additional components that must be included in a request for certification when EPA acts as the
certifying authority or in instances when a state or authorized Tribe declines to define additional
components. See preamble section IV.C. Although the Agency is allowing states and authorized Tribes to
define their own additional requirements for a request for certification, the provision provides a clear
backstop for those states or authorized Tribes who do not choose to define any additional requirements.
However, if a state or authorized Tribe chooses to define additional requirements, the final rule provides
that those additional components must be water quality-related and must be identified prior to when
the request for certification is made. The Agency expects that this will ensure that project proponents
have full transparency and certainty as to what is required as well as ensure that the request remains
within the scope of certification. Additionally, EPA anticipates that allowing states and authorized Tribes
to define additional contents of a certification request may reduce the need for additional information
requests. As a result, the Agency anticipates this new requirement to result in faster, more efficient
decision-making by the certifying authorities than under the 1971 Rule and 2020 Rule baselines, which
may reduce the economic impact on project proponents.

Third, EPA is also returning to the longstanding "activity" scope of certification review, which represents
a change from the 2020 Rule baseline. The 1971 Rule did not explicitly address the scope of certification
in regulatory text. However, the U.S. Supreme Court held that section 401 "is most reasonably read" as
authorizing the certifying authority to evaluate and place conditions on the "activity as a whole" to
assure compliance with various provisions of the CWA and "any other appropriate requirement of State
law" once the predicate existence of a discharge is satisfied. PUD No. 1 of Jefferson County v. WA Dept.
of Ecology, 511 U.S. 700, 711-12 (1994). In pre-proposal input, several project proponents asserted that
prior to the 2020 Rule, certifying authorities considered non-water quality-related issues and supported
the 2020 Rule's discharge-only scope of review.60 In public comment, several project proponents
expressed concern over certifications or conditions that are not related to water quality effects or water

59	See, e.g., Edition Electric Institute (EPA-HQ-OW-2022-0128-0153); Petroleum Association of Wyoming (EPA-HQ-
OW-2022-0128-0160).

60	See, e.g., National Hydropower Association (EPA-HQ-OW-2021-0302-0048), Interstate Natural Gas Association of
America and American Gas Association (EPA-HQ-OW-2021-0302-0058), Equitrans Midstream Corporation (EPA-
HQ-OW-2021-0302-0073).

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quality impacts.61 Although the final rule returns to the "activity" scope of review, the provision retains
the Agency's longstanding position that certifying authorities may only consider water quality-related
impacts when acting on a request for certification. The final rule preamble also clarifies that the
certifying authority's analysis is limited to addressing impacts from an activity that adversely affects
water quality in a manner that causes or contributes to noncompliance with a water quality
requirement. The "activity" scope of review can result in an increase in the number of water quality
certification conditions, relative to the 2020 Rule baseline and proportional to the size and complexity of
the activity; however, this provision clarifies that the scope of certification is limited to water quality-
related impacts. As a result, certification decisions, including any certification conditions, are more likely
to be appropriately limited to water quality-related impacts. Given these factors and that most certifying
authorities are familiar with the "activity" approach, the direct economic impact of this change on
project proponents is not expected to be significant.

Fourth, the Agency is reintroducing a certification modifications provision. In response to pre-proposal
input, stakeholder recommendations, and public comment to allow certification modifications, the
Agency is finalizing a process similar to the 1971 Rule that allows a certifying authority to modify a grant
of certification after reaching an agreement to do so with the Federal licensing or permitting agency. In
contrast, the 2020 Rule removed the 1971 Rule's modification provision in its entirety, and instead
relied on other Federal agencies to define if and when such modifications could occur. The 2020 Rule
preamble also suggested that there might be circumstances warranting the submission of a new request
for certification; however, the Agency declined to identify circumstances that might warrant the
submission of a new certification request. Therefore, during the pre-proposal input period, stakeholders
said they need more flexibility than the 2020 Rule provided for modifications.62 In response to the
proposed approach, several commenters asserted that finalizing a provision for limited certification
modifications will provide necessary flexibility for project proponents without resulting in delays or
inefficiencies that would happen if they had to re-request certification after the project is already under
construction.63 Relative to the 2020 Rule, the Agency expects the reintroduction of a certification
modification provision to reduce burden on small entities acting as project proponents by adding the
flexibility they need to adapt to changing circumstances or new information, without limiting them to
submission of a new request for certification when the Federal agency has not established other
modification mechanisms. The final rule certification modification provision protects the reliance
interests of project proponents because it is clear that unilateral modifications are not allowed, and
through the modification process a certifying authority cannot revoke or change a grant of certification
into a denial or waiver of certification. Furthermore, this provision reduces the burden on small entities
acting as project proponents, relative to the 1971 Rule, because the revision does not include a third-

61	See, e.g., Association of American Railroads (EPA-HQ-OW-2022-0122), Calista Corporation (EPA-HQ-OW-2022-
0099), Cleco Corporate Holdings (EPA-HQ-OW-2022-0121), Interstate Natural Gas Association of America and
American Gas Association (EPA-HQ-OW-2022-0122).

62	See, e.g., American Association of State Highway and Transportation Officials (EPA-HQ-OW-2021-0302-0029),
Edison Electric Institute (EPA-HQ-OW-2021-0302-0049), Massachusetts Department of Transportation (EPA-HQ-
OW-2021-0302-0055).

63	See, e.g., Natural Gas Supply Association (EPA-HQ-OW-2022-0128-0185), California Department of
Transportation (EPA-HQ-OW-2022-0128-0105), Cross Cutting Issues Group (EPA-HQ-OW-2022-0128-0171).

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party role for EPA participation in certification modifications. EPA anticipates that the exclusion of the
third-party role for EPA will streamline collaboration regarding certification modifications.

Lastly, the Agency is updating the 2020 Rule regulatory text regarding the section 401(a)(2) process (also
known as the neighboring jurisdictions process) to provide greater clarity regarding how the section
401(a)(2) process is initiated and conducted. These updates include clarifying that waivers in addition to
certifications trigger the section 401(a)(2) process; defining the contents of notification from a Federal
agency to EPA; clarifying that EPA must determine whether a discharge may affect a neighboring
jurisdiction after it receives notification; and clarifying the notified neighboring jurisdiction's objection
process. Although project proponents are not directly impacted by the neighboring jurisdictions process,
the Agency anticipates that the provision may have an indirect impact on project proponents (some of
which may be small entities) because a Federal license or permit may not be issued until the neighboring
jurisdictions process concludes. The provision reintroduces the longstanding practice of waivers, in
addition to certifications, triggering the neighboring jurisdictions process. However, the provision
provides further clarification of the neighboring jurisdictions process beyond what was included in the
2020 Rule (e.g., contents of notification) and adds a provision for the notified neighboring jurisdiction to
withdraw its objection prior to the public hearing, which will allow the neighboring jurisdictions process
to be more efficient. The Agency also anticipates greater efficiency when moving from the 1971 Rule
baseline to the final provision, due to the clarifications and procedural framework for objections and
hearings included in the final rule. EPA acknowledges that the clarity may increase the number of
jurisdictions that object or request hearings under section 401(a)(2).

7.4.2 Anticipated Impacts to Small Entities

Despite the direct impacts discussed in Section 7.4.1 above to project proponents, including some small
entities, the Agency has concluded that this final rule will not have a significant economic impact on a
substantial number of small entities. To support a certification under RFA, EPA has conducted a
qualitative analysis of the impacts to small businesses, as a courtesy, as these small businesses are not
directly regulated by this rule.

Approximately 94 percent of certification requests derive from general licenses or permits (see Table
3-7). EPA expects that the small entities affected by this final rule are the project proponents who
predominantly avail themselves of general licenses or permits. This presumption is based on the
likelihood that small firms develop expertise around filling economic niches in which larger firms are
uninterested, because the larger firms can make greater profits on projects for which they have a size
advantage (e.g., there are market-based barriers to entry for small firms). For example, the CWA section
404 general permit for Residential Developments is limited to projects resulting in the loss of non-tidal
waters of the United States of no more than a half-acre. Of course, a large residential development, built
by a large firm, could have an impact that would be this minimal on waters of the United States.
However, all other things being equal, the likelihood of disturbing more acres grows with the size of the
development, and the more diverse skills required to manage the greater rigors of the individual permit
process are more likely to be found in larger firms. If a project proponent uses a general license or
permit that has already obtained certification (i.e., certification on the issuance of the general license or
permit), then the project proponent does not need to seek certification prior to authorization. However,
if the general license or permit requires a project-specific certification prior to authorization, the project
proponent will be required to seek certification in accordance with this final rule. EPA assumes that a
greater number of project proponents (especially small entities) seeking general license or permit

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authorizations will not need to request certification, but the incremental impacts of this final rule on
project proponents who will be required to seek section 401 certification are qualitatively discussed
below.

For the qualitative assessment, EPA considered the impacts on project proponents seeking certification
by dividing them into three mutually exclusive and exhaustive groups: 1) project proponents for whom
there are no incremental costs; 2) project proponents for whom the pre-filing meeting request
requirement is the largest impact; and 3) project proponents for whom one or more of the other
provisions have an impact (e.g., scope of certification, modifications, neighboring jurisdictions process,
etc.). This analysis describes the three groups and their particular features first, and then analyzes the
small business impacts relative to each baseline. Although EPA lacks detailed information on project
proponents, the total effect across these three groups, under both baselines, gives EPA confidence that
there is no significant impact on a substantial number of small entities.

7.4.2.1 Group 1: Project Proponents for Whom there Are No Incremental Costs
The first group includes project proponents for whom the pre-filing meeting request requirement is
waived by the certifying authority under the final rule. Relative to the 2020 Rule baseline, this group will
not face incremental costs because the pre-filing meeting was also a feature of the 2020 Rule. In fact,
this group will realize cost savings relative to the 2020 Rule because the pre-filing meeting request
cannot be waived under that baseline; these cost savings are expected to be relatively low, on the order
of hundreds to thousands of dollars. Relative to the 1971 Rule baseline, this group will not face
incremental costs under the final rule because waiver of the pre-filing meeting request requirement is
equivalent to the 1971 Rule's lack of a pre-filing meeting request requirement.

Pre-filing meeting requests ensure that certifying authorities can receive early notification of and discuss
the project and the required contents of the request for certification with the project proponent before
the submission of the request for certification. It is important to understand the required contents of
the request for certification because the statutory "reasonable period of time" for certification review
begins on the date that the certifying authority receives the request for certification. EPA assumes that if
a certifying authority has chosen to waive the pre-filing meeting request requirement, the project
proponent's request for certification will be generic - and could even be a project-specific request for
certification to obtain a general license or permit authorization. Under the final rule, project proponents
are required to provide a request for certification that, at a minimum, includes a copy of the license or
permit application and any readily available water quality-related materials that informed the
development of the application (for individual licenses and permits). This information should not require
any additional, independent development by the project proponent since it includes information the
project proponent has already developed for the license or permit application process. Furthermore,
some certifying authorities may return to the joint application process that was used prior to the 2020
Rule's required contents for all requests for certification. Therefore, EPA anticipates that project
proponents in this category will not face any incremental costs relative to the 1971 Rule practice, while
there will be a cost reduction relative to the 2020 Rule because under the 2020 Rule, project proponents
could not jointly apply for the Federal license or permit and certification.

Once the request for certification is submitted, the certifying authority is responsible for evaluating
whether the activity will comply with applicable water quality requirements. As discussed above, the
"activity" scope of review represents a return to pre-2020 Rule practices. There can be an increase in

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the number of water quality certification conditions, relative to the 2020 Rule baseline and proportional
to the size and complexity of the activity; however, the final rule clarifies that the scope of certification
is limited to water quality-related impacts. As a result, certification decisions, including any certification
conditions, are more likely to be appropriately limited to water quality-related impacts. Given these
factors and that most certifying authorities are familiar with the "activity" approach from before the
2020 Rule, the direct economic impact of this change on project proponents seeking certification for
small/generic projects (e.g., for authorization under a general license or permit) is not expected to be
significant.

After a certifying authority grants certification (with or without conditions) or waives certification, the
Federal agency must provide written notification to EPA within five days of the date that it received both
the application and either a certification or waiver, pursuant to the section 401(a)(2) neighboring
jurisdictions process. Because the Federal agency cannot issue the license or permit until the process
concludes, EPA acknowledges that some project proponents may have to wait longer for the process to
conclude - because under the 2020 Rule, waivers of certification did not trigger the neighboring
jurisdictions process. However, this change represents a return to the 1971 Rule practice, but the final
rule provides additional clarity that is intended to support streamlining/efficient determinations (e.g.,
the content of the notification to EPA). Furthermore, smaller projects that are generally less complex are
less likely to lead to a "may affect" finding (e.g., when project proponents are seeking a project-specific
certification to obtain a general license or permit authorization because general licenses or permits are
developed to minimize cumulative adverse effects). Therefore, EPA anticipates that the return to past
practices in combination with the additional clarity will not result in significant incremental costs for
project proponents seeking certification for smaller/generic projects.

Lastly, under the modification provision in the final rule, a certifying authority may only modify a grant
of certification (with or without conditions) after the certifying authority and the Federal agency have
agreed in writing that the certifying authority may modify an element or portion of the certification. The
final rule protects the reliance interests of project proponents by preventing unilateral modifications
after the reasonable period of time, and under the final rule provision, a certifying authority cannot
revoke or change a grant of certification into a denial or waiver of certification. EPA anticipates that this
provision will reduce costs, relative to the 2020 Rule, for project proponents who would have been
required to re-initiate the certification process in light of a shift in project design or construction after
the certification was issued. Relative to the modification provision in the 1971 Rule, the modification
agreement can be reached more quickly because the final rule does not include EPA as a party to the
modification agreement when EPA is neither the certifying authority nor the Federal permitting agency.
This means that the final rule will also reduce project proponent costs compared to the 1971 Rule.

To summarize the impacts to this group relative to the 2020 Rule baseline, there is potential for both
incremental costs and cost reductions, but these impacts are quite low and thus not expected to be
significant impacts. To summarize the impacts to this group relative to the 1971 Rule baseline, the
impacts result in no net burden.

7.4.2.2 Group 2: Project Proponents for Whom the Pre-filing Meeting Request Requirement is the
Largest impact

The second group faces more costs under the final rule than the first group, because the certifying
authority does not waive their pre-filing meeting request requirement. What distinguishes this group

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from the third group is that the higher costs they face relative to the first group are limited to the pre-
filing meeting request requirement. Although it would be difficult to predict with much specificity the
costs of pre-filing meetings, a reasonable set of assumptions includes that pre-filing meetings will entail
approximately 30 labor hours (abstracting from several people for a few hours, plus preparation) at an
average wage rate of $100/hour (abstracting from labor categories).64 Thus, EPA estimates that these
costs in the abstract are on an order of magnitude in thousands of dollars per certification decision.
These relative costs are therefore not expected to impose a significant impact on project proponents,
with the possible exception of the very smallest firms in this group. Furthermore, this group is not
expected to be comprised solely of small entities, but rather that small businesses would be a subset of
this group. Additionally, the project proponents in this group are expected to be comprised of a minority
of the general licenses or permits and most of the individual permits or licenses in Table 3-7 (the
remaining of this latter category being in the third group).

To summarize the impacts to this group relative to the 2020 Rule baseline, the impacts result in no net
burden because project proponents in this group are treated similarly under the 2020 Rule baseline and
final rule. To summarize the impacts to this group relative to the 1971 Rule baseline, there are impacts,
but these impacts are only expected to be significant for an insubstantial number of small entities.
Additionally, early engagement through pre-filing meetings may reduce burdens in other aspects of the
certification process, such as helping project proponents provide relevant information in the initial
request for certification, helping certifying authorities act within the reasonable period of time, and
reducing back-and-forth communication between project proponents and certifying authorities.

7.4.2.3 Group 3: Project Proponents for Whom One or More of the Other Provisions Have an Impact
The third group is the group most likely to face costs of a magnitude that could rise to the level of
significant impacts, because they face the same costs under the final rule as the second group, as well as
costs associated with another part of the section 401 process, such as the request for certification,
scope of certification, modifications, or the neighboring jurisdictions process. For example, if a certifying
authority defines additional contents for a request for certification, it may require additional materials
for more complex and/or larger projects, in addition to the minimum contents required for a request for
certification. A more complex and/or larger project could also require more certification conditions or
require modifications at a later date. Similarly, a more complex and/or larger project in a shared
watershed may be more likely to lead to a "may affect" determination and/or "will violate"
determination that may delay license or permit issuance. EPA acknowledges that in some instances,
these costs could impose a significant impact. However, EPA assumes that the project proponents facing
these impacts would most likely not be small entities, precisely because these more complex situations
or larger projects require broader skill sets most often found in firms exceeding the small business size
standards. Additionally, these projects are more likely to require individual licenses or permits (as
opposed to general licenses or permits), which EPA assumes are generally obtained by project
proponents that are not small entities.

To summarize the impacts to this group relative to the 2020 Rule baseline, there will be either impacts
associated with request for certification, scope of certification, modification, or neighboring jurisdiction
(or all); these impacts can be of a magnitude that would be significant for small entities, but EPA does
not expect that there are a substantial number of small entities in this group. However, these impacts

64 This wage rate is on the order of magnitude of the wage rates used in the ICR for this final rule.

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can be mitigated by the final rule's clarification of these provisions. For the request for certification, the
final rule clarifies that any additional components in a request for certification must be water quality-
related and clearly defined prior to the request for certification. For the scope of certification, the final
rule clarifies that the scope of certification is limited to water quality-related impacts. For modifications,
the final rule limits modifications to grants of certification (with or without conditions) subject to Federal
agency and certifying authority agreement. For the neighboring jurisdictions process, the final rule
provides additional clarity that is intended to support streamlining/efficient determinations.

To summarize the impacts to this group relative to the 1971 Rule baseline, there will be no impacts
associated with request for certification, scope of certification, or modification, though there can be
neighboring jurisdiction impacts; the final rule, however, introduces greater procedural clarity and
efficiency in the neighboring jurisdiction process, including the ability for notified neighboring
jurisdictions to withdraw objections to the issuance of a license or permit, which can mitigate some of
the impact. These impacts could be of a magnitude that would be significant for small entities, but EPA
does not expect there to be a substantial number of small entities in this group.

7.5 Executive Order 13211 Actions Concerning Regulations that Significantly
Affect Energy Supply, Distribution, or Use

Some Federal licenses and permits that relate to the supply and distribution of energy, such as Federal
construction and operation licenses or permits, are subject to CWA section 401 certification if the
activity may result in a discharge into waters of the United States. However, this rulemaking does not
impact existing federally licensed or permitted projects - except for making it easier to modify elements
of a previously issued grant of certification. See Section 4.9 for discussion of the modification provision.
As discussed throughout this economic analysis, EPA anticipates that this final rule will improve the
efficiency of the certification review process for new requests for certification, which will support
efficiency in the related Federal license or permit review processes. Therefore, there are no direct
impacts from this rulemaking on the supply, distribution, or use of energy, and any indirect impacts of
this final rule will be neither adverse nor significant on the supply, distribution, or use of energy.

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Appendix A. Rule Provision Comparison

Table A-l compares major rule provisions, in plain language, under the 1971 Rule, the 2020 Rule, and the final rule.

Table A-l. Comparison of rule provisions under the 1971 Rule, the 2020 Rule, and the final rule

1971 Rule and Practice

2020 Rule

Final Rule

When certification is required

•	A project proponent must request section
401 certification from the appropriate
certifying authority if a federally licensed or
permitted activity may result in a discharge
into waters of the United States.

•	While not addressed in 1971 Rule, case law
from the 9th Circuit held that only a point
source discharge triggers section 401 (ONDA
v. Dombeck, 172 F.3d 1092 (9th Cir. 1998)).

•	Same as 1971 practice, but the regulatory
text explicitly provided that certification is
required for any license or permit that
authorizes an activity that may result in a
discharge.

•	Defined "discharge" for purposes of section
401 as a discharge from a point source into a
water of the United States, consistent with
ONDA.

•	Same as 1971 practice, but the regulatory
text explicitly provides that a certification or
waiver is required for any license or permit
that authorizes any activity which may result
in a point source discharge into waters of the
United States.

•	Preamble provides that a discharge for
purposes of section 401 is a discharge from a
point source into waters of the United States,
consistent with ONDA.

Pre-filing meeting request

• Pre-filing meeting requests were not required
by rule but were encouraged by some
certifying authorities.

• Project proponents were required to request
a pre-filing meeting from a certifying
authority at least 30 days before requesting
certification.

• Project proponents are required to request a
pre-filing meeting with a certifying authority
at least 30 days prior to requesting
certification, unless waived or shortened by
the certifying authority.

Request for certification

•	Included five components that must be in a
certification request when EPA is the
certifying authority.

•	Did not define a certification request for
other certifying authorities.

•	In practice, some states and authorized Tribes
said a "complete application" constituted a
certification request.

• Required all certification requests to be

written, signed, and dated and include either
seven or nine components, which are based
on whether the certification request was for
an individual license or permit, or the
issuance of a general license or permit.

•	Requires all requests for certification to be in
writing, signed, and dated.

•	If the request for certification is for an
individual license or permit, it must include a
copy of the license or permit application
submitted to the federal agency and any
readily available water quality-related
materials that informed the development of
the application.

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Table A-l. Comparison of rule provisions under the 1971 Rule, the 2020 Rule, and the final rule

1971 Rule and Practice

2020 Rule

Final Rule





•	If the request for certification is for the
issuance of a general license or permit, it
must include a copy of the draft license or
permit and any existing and readily available
water quality-related materials that informed
the development of the draft license or
permit.

•	Requires all requests for certification to EPA
to include seven additional items, as
applicable; this requirement also applies to
requests for certification to states or
authorized Tribes that do not identify
additional contents for a request for
certification.

•	States and authorized Tribes are free to
identify additional contents for a request for
certification that are relevant to the water
quality-related impacts from the activity prior
to when the request for certification is made.

Reasonable period of time (RPT)

When the RPT starts:

•	The RPT began after the receipt of a
certification request.

•	In practice, some certifying authorities
required a "complete application" to start the
RPT.

•	A project proponent was required to submit a
certification request to the certifying
authority and Federal agency concurrently.

•	The RPT began on the date that a certification
request is documented as received by a
certifying authority in accordance with
applicable submission procedures.

•	The RPT begins on the date that the certifying
authority receives a request for certification
as discussed in the section above and in
accordance with the certifying authority's
applicable submission procedures.

•	Certifying authority must notify the Federal
agency and project proponent, in writing, of
the date that the request for certification was
received.

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Table A-l. Comparison of rule provisions under the 1971 Rule, the 2020 Rule, and the final rule

1971 Rule and Practice

2020 Rule

Final Rule

Timeline for acting:

•	A certifying authority must act on a request
for certification within the RPT, which shall
not exceed one year, as determined by the
Federal agency.

•	Rule provided for a default RPT of generally
six months.

•	A certifying authority had to act on a request
for certification within the RPT, which shall
not exceed one year, as determined by the
Federal agency.

•	Rule did not provide a default RPT.

•	A certifying authority must act on a request
for certification within the RPT, which shall
not exceed one year, as determined by the
Federal agency and certifying authority.

•	If the certifying authority and Federal agency
do not come to an agreement on the RPT, it
will default to six months.

How the RPT is set:

•	Federal agency expected to set the RPT;
process not specified in rule.

•	In practice, Federal agencies specified default
RPT in regulations.

•	Federal agency was required to set the RPT
either categorically or on a case-by-case basis
within 15 days of receiving a certification
request.

•	Preamble provided that the RPT will default
to a categorical RPT (if specified in a Federal
agency's regulations) or one year (if the
Federal agency did not have a categorical RPT
in its regulations) if the Federal agency failed
to set an RPT within 15 days of receiving a
certification request.

•	Rule provided factors that the Federal agency
must consider when establishing the RPT.

•	Certifying authority and Federal agency may
jointly set the RPT.

•	If the certifying authority and Federal agency
do not reach an agreement on the RPT in
writing, the RPT defaults to six months.

•	Final rule does not specify factors that the
Federal agency and certifying authority must
consider when setting the RPT.

Extending the RPT:

• Not specified in rule, but some Federal
agencies included procedures for modifying
the RPT in their water quality certification
implementation regulations.

•	Certifying authorities and project proponents
could request an extension to the RPT, but
the Federal agency was not required to grant
the extension request.

•	The extension may not extend the RPT
beyond one year from receipt of the
certification request.

•	RPT is automatically extended upon
notification by the certifying authority prior
to the end of the reasonable period of time in
two scenarios: need to meet public notice
procedures and force majeure events.

•	RPT may be extended upon certifying
authority and Federal agency agreement for
any reason, as long as it does not extend

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Table A-l. Comparison of rule provisions under the 1971 Rule, the 2020 Rule, and the final rule

1971 Rule and Practice

2020 Rule

Final Rule





beyond one year from the date that the
request for certification was received.

Stopping/pausing the RPT:

•	Not specified in rule.

•	In practice, some certifying authorities
requested or allowed project proponents to
withdraw their applications to
stop/pause/restart the clock.

• The withdrawal/resubmit practice was
prohibited in regulatory text.

• Declines to take a position on validity of the
withdrawal/resubmit practice.

Scope of review and scope of conditions

•	Not specified in regulatory text.

•	In 1994, the Supreme Court stated that the
scope of a jurisdiction's certification review
includes assuring that any potential point
source discharge, as well as the
licensed/permitted activity as a whole, will
comply with sections 301, 302, 303, 306, and
307 of the Clean Water Act and "any other
appropriate requirements of State or tribal
law." (PUD No. 1 of Jefferson County v. WA
Dept. of Ecology, 511 U.S. 700 (1994))

•	The scope of certification was limited to
assuring that a discharge from a federally
licensed or permitted activity will comply
with water quality requirements.

•	Water quality requirements were defined as
the applicable provisions of CWA sections
301, 302, 303, 306, and 307, and state or
Tribal regulatory requirements for point
source discharges into waters of the United
States.

•	The scope of certification is based on
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 license or permit,
including the activity's construction and
operation.

•	Water quality requirements are defined as
any limitation, standard, or other
requirement under CWA sections 301, 302,
303, 306, and 307, any Federal and state or
Tribal laws or regulations implementing those
sections, and any other water quality-related
requirement of state orTribal law.

•	Scope of review for a certification decision is
the same as the scope of permissible
conditions that may be added to that
certification.

Certification decisions

Granting certification:

• A grant of certification included five elements
that must be included in a certification,

• A grant of certification was required to be in
writing and include a statement that the

• A grant of certification must be in writing and
should include (1) identification of the

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Table A-l. Comparison of rule provisions under the 1971 Rule, the 2020 Rule, and the final rule

1971 Rule and Practice

2020 Rule

Final Rule

including "[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."

discharge from the proposed project will
comply with water quality requirements.

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).

Granting certification with conditions:

•	A grant of certification with conditions
included the same elements as a grant of
certification, including "a statement of any
conditions which the certifying agency deems
necessary or desirable with respect to the
discharge of the activity."

•	No further information required with the
certification condition.

•	A grant of certification with conditions for an
individual license or permit was required to
be in writing and include (1) a statement
explaining why the condition is necessary to
assure that the discharge from the proposed
project will comply with water quality
requirements, and (2) a citation to Federal,
state, or Tribal law that authorizes the
condition.

•	Included a similar requirement for a grant of
certification with conditions on issuance of a
general license or permit.

• A grant of certification with conditions must
be in writing and should include (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, (4) an indication that
the certifying authority complied with its
public notice procedures established
pursuant to Clean Water Act section
401(a)(1).

Denying certification:

• Not specified.

• A denial of certification on an individual
license or permit was required to be in
writing and include (1) the specific water
quality requirements with which the
discharge will not comply, (2) a statement
explaining why the discharge will not comply
with the identified water quality

• A denial of certification must be in writing
and should include (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

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2020 Rule

Final Rule

requirements, and (3) if the denial is due to
insufficient information, the denial must
describe 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.

Included a similar requirement for a denial of
certification on issuance of a general license
or permit.

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).

Waiving certification:

A certifying authority could waive
certification (1) expressly or (2) by failing or
refusing act, which was not defined in the
regulation, although in practice Federal
agencies sometimes determined waiver
occurred by passage of time.

•	A certifying authority could waive
certification (1) expressly or (2) by failing or
refusing to act.

•	An express waiver was required to be in
writing.

•	A certifying authority could fail or refuse to
act on a request for certification by (1) failing
or refusing to act on a certification request
within the RPT, (2) failing or refusing to
satisfy the requirements for a grant of
certification (described above), (3) failing or
refusing to satisfy the requirements for a
denial of certification (described above), or
(4) failing or refusing to comply with other
procedural requirements of section 401.

•	A certifying authority could also waive a
certification condition by failing or refusing to
satisfy the requirements for a grant of
certification with conditions (described
above).

A certifying authority may waive certification

(1)	expressly or (2) by failing or refusing to
act.

An express waiver must be in writing and
should include (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, (4) an indication that the
certifying authority complied with its public
notice procedures established pursuant to
Clean Water Act section 401(a)(1).

A certifying authority fails or refuses to act on
a request for certification by failing to make a
certification decision within the RPT.

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1971 Rule and Practice

2020 Rule

Final Rule

Federal agency review

Scope of Federal agency review

• Not addressed in rule but, in practice, a

• A Federal agency was required to review a

•

A Federal agency may verify compliance with

Federal agency determined whether a

grant of certification, grant of certification



three requirements of section 401: (1)

certifying authority failed to act within the

with conditions, or denial of certification to



whether the appropriate certifying authority

RPT.

determine whether it complied with the



issued the decision, (2) whether the certifying

• Some case law provided Federal agencies

procedural requirements for those actions



authority confirmed it complied with its

with the ability to review for compliance with

(e.g., denial of certification element



public notice procedures established

facial section 401 statutory requirements,

requirements), whether the actions were



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

including public notice provision, RPT, and

issued within the RPT, and whether the



whether the certifying authority acted on the

appropriate certifying authority.

actions followed the other procedural



request for certification within the RPT.



requirements of section 401 (e.g., public

•

Explicitly limits Federal agency review to the



notice).

•

three factors above.

Defers to certifying authorities to determine
how to demonstrate that it met the three
listed facial elements.

Consequences of Federal agency review

• Not addressed in rule. In practice, a waiver

• A Federal agency could waive a state's or

•

A waiver may only occur for failure to act

occurred if Federal agency determined the

authorized Tribe's certification decision or



within the RPT.

certifying authority failed to act within the

condition for failure to act within the RPT,





RPT.

and failure to comply with the procedural
requirements of section 401 (e.g., public
notice) or the 2020 Rule (e.g., denial of
certification element requirements).

• Federal agencies were not required to
provide the certifying authority with the
opportunity to remedy any deficiency.





Modifications

• The 1971 Rule allowed modifications upon

• Removed the 1971 modification provision.

•

Clarifies that unilateral modifications to

agreement by the Federal agency, certifying





granted certifications are not allowed.

authority, and EPA.







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2020 Rule

Final Rule



• The 2020 Rule relied on other Federal agency
regulations to address certification
modifications instead.

•	A certifying authority and a Federal agency
may agree to modify a grant of certification
(with or without conditions). The
modification is limited to the scope of the
agreement (e.g., if they agree that the
construction timeframe needs to be
extended, only that aspect of the certification
may be modified); however, the certifying
authority is not required to obtain the
Federal agency's agreement on the text of
the modification.

•	EPA is removing itself from the list of entities
in the 1971 Rule that must reach agreement
for modifications to occur.

•	Clarifies that the modification process cannot
be used to revoke or change a grant of
certification into a denial or waiver.

Neighboring Jurisdictions Process

Notice from Federal agency to EPA

•	Required Federal agency to notify EPA upon
receipt of an application and a certification or
waiver.

•	Notification included a copy of the
certification or waiver, and the portions of
the Federal license or permit application
related to water quality considerations.

•	EPA could ask Federal agency to procure
additional information from the project
applicant.

•	Required the Federal agency to notify EPA
within five days of receiving a license or
permit application and the related
certification.

•	Did not define the contents of a Federal
agency's notification to EPA.

•	Allowed EPA to request copies of the
certification and the Federal license or permit
application.

•	Requires the Federal agency to notify EPA
within five days of receiving the application
and either a certification or waiver.

•	Defines the contents of a Federal agency's
notification to EPA, but also provides EPA
with the option of entering into agreements
with Federal agencies regarding the manner
and contents of notification.

•	Allows EPA to request supplemental
information.

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1971 Rule and Practice

2020 Rule

Final Rule

EPA's "may affect" evaluation and notice to neighboring state/authorized Tribe

•	Rule did not define what "may affect" means;
in practice, EPA interpreted section 401(a)(2)
as providing EPA with the discretion to
determine whether the discharge from a
project may affect the water quality in a
neighboring jurisdiction; however, one
district court found that EPA is required to
make a determination about whether a
discharge may affect a neighboring
state/authorized Tribe (Fond du Lac Band of
Lake Superior Chippewa v. EPA, 519 F.Supp.3d
549 (D. Minn. 2021)).

•	Rule provided that if EPA determines that the
discharge from a project may affect water
quality in a neighboring jurisdiction, EPA shall
notify the neighboring jurisdiction, certifying
authority, Federal agency, and applicant.

•	Required EPA to send any materials it reviews
to the neighboring state/authorized Tribe.

•	Provided that the Administrator at his or her
discretion may determine that the discharge
from the certified project may affect water
quality in a neighboring jurisdiction.

•	Defined what EPA would have to provide to
neighboring states and authorized Tribes
when it determines that a discharge may
affect a neighboring state or authorized
Tribe.

•	Required EPA to notify the neighboring state
or authorized Tribe, Federal agency, project
proponent, and the certifying authority.

•	Clearly stated that a Federal license or permit
may not be issued until the neighboring
jurisdictions process concludes.

•	Clarifies that EPA must determine whether a
discharge "may affect" water quality in a
neighboring state or authorized Tribe.

•	Defines what EPA provides to neighboring
states and authorized Tribes when it
determines that a discharge from the project
may affect a neighboring state or authorized
Tribe.

•	Requires EPA to notify the neighboring state
or authorized Tribe, Federal agency, and
project proponent.

•	Clearly states that a Federal license or permit
shall not be issued until the neighboring
jurisdictions process concludes.

Neighboring state/authorized Tribe "will violate" objection

• Not specified in rule.

•	Required the neighboring jurisdiction to
notify EPA and the Federal agency if it
objected to the issuance of the Federal
license or permit.

•	Defined what the neighboring jurisdiction
must provide in its notification to EPA and the
Federal agency.

•	Requires the neighboring jurisdiction to notify
EPA and the Federal agency if it objects to the
issuance of the Federal license or permit.

•	Defines what the notified neighboring
jurisdiction must provide in its notification to
EPA and the Federal agency.

Objection and hearing process

•	Required the Federal agency to notify EPA at
least 30 days before the public hearing.

•	Required EPA to provide its evaluation and
recommendations at the public hearing,

•	Required the Federal agency to notify EPA at
least 30 days before the public hearing.

•	Required EPA to provide its evaluation and
recommendations at the public hearing.

• Allows the notified neighboring jurisdiction to
withdraw its objection prior to the public
hearing.

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2020 Rule

Final Rule

including recommendation as to whether and
under what conditions the license/permit
should be issued.

• Clarified that the license or permit may not
be issued if additional license or permit
conditions cannot ensure that the discharge
from the certified project will comply with
the neighboring jurisdiction's water quality
requirements.

•	Explicitly reiterates that the Federal agency
must hold a public hearing if the notified
neighboring state or authorized Tribe
requests one.

•	Requires the Federal agency to provide public
notice to interested parties at least 30 days
prior to the hearing.

•	Requires EPA to provide its evaluation and
recommendations at the hearing.

•	Clarifies that the license or permit may not be
issued if additional license or permit
conditions cannot ensure that the discharge
from the project will comply with the notified
neighboring jurisdiction's water quality
requirements.

Treatment in a Similar Manner as a State for Section 401

•	Rule did not provide Tribes with the
opportunity to receive TAS solely for section
401.

•	In practice, Tribes received TAS for section
401 by receiving TAS for water quality
standards.

•	Tribes without TAS were unable to participate
as a neighboring jurisdiction under the
section 401(a)(2) neighboring jurisdictions
process.

•	Rule did not provide Tribes with the
opportunity to receive TAS solely for section
401.

•	In practice, Tribes received TAS for section
401 by receiving TAS for water quality
standards.

•	Tribes without TAS were unable to participate
as a neighboring jurisdiction under the
section 401(a)(2) neighboring jurisdictions
process.

•	Provides Tribes with a new section 401-
specific alternative option for obtaining
section 401 TAS without also obtaining TAS
for water quality standards.

•	Provides Tribes with an option to obtain TAS
solely for participating as a neighboring
jurisdiction in the section 401(a)(2)
neighboring jurisdictions process.

EPA as a Certifying Authority

• Specified how/to whom EPA must provide
public notice on a certification request when
it is the certifying authority.

•	Clarified when EPA acts as the certifying
authority on behalf of a jurisdiction.

•	Required EPA to provide public notice within
20 days of receiving a certification request to
parties known to be interested in the

•	Clarifies when EPA acts as the certifying
authority on behalf of a jurisdiction.

•	Requires EPA to provide public notice within
20 days of the date that the request for
certification was received, but enables EPA to

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2020 Rule

Final Rule

• Limited the subject matter of a public hearing
to whether EPA should grant or deny a
request for certification.

proposed project or in the receiving waters
into which the discharge may occur.

•	Did not limit the scope of a public hearing on
a certification request.

•	Allowed EPA to request additional
information from a project proponent on a
request for certification, but only if the initial
request is made within 30 days of receipt of
the certification request.

•	Limited EPA's request for additional
information to only that which was within the
scope of certification, directly related to the
discharge from the proposed project and its
potential effects on receiving waters, and
able to be collected or generated in the
reasonable period of time.

determine the best methods/means to
provide the public notice.

•	Clarifies that EPA must provide an
opportunity for public comment after
providing notice.

•	Does not limit the scope of a public hearing
on a request for certification.

Technical Assistance

•	EPA may, and upon request shall, provide
Federal agencies with determinations,
definitions, and interpretations with respect
to the meaning and content of federally
approved water quality standards, and
findings with respect to the application of all
applicable water quality standards.

•	EPA may, and upon request shall, advise
Federal agencies as to the status of
compliance by dischargers with the
conditions and requirements of applicable
water quality standards.

•	EPA may advise Federal agencies with respect
to conditions to achieve compliance with the
CWA's purpose where there are no applicable
water quality standards.

• EPA may, and upon request shall, provide
Federal agencies, certifying authorities, and
project proponents with relevant information
and assistance regarding the meaning of,
content of, application of, and methods to
comply with water quality requirements.

• Upon request, EPA must provide Federal
agencies, certifying authorities, and project
proponents with 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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