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EO12866_RTCR Part 141 and 142 2040-AD94 Final Rule FRN_201111212012080120121115

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 141 and 142

[EPA-HQ-OW-2008-0878; FRL-9684-8 ]

RIN 2040-AD94

National Primary Drinking Water Regulations: Revisions to the Total Coliform Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Rule.

SUMMARY: The Environmental Protection Agency (EPA or the Agency) is finalizing 

revisions to the 1989 Total Coliform Rule (TCR). The Revised Total Coliform Rule (RTCR) 

offers a meaningful opportunity for greater public health protection beyond the 1989 TCR. 

Under the RTCR there is no longer a monthly maximum contaminant level (MCL) violation for 

multiple total coliform (TC) detections. Instead, tThe revisions require systems that have an 

indication of coliform contamination in the distribution system to assess the problem and take 

corrective action that may reduce cases of illnesses and deaths due to potential fecal 

contamination and waterborne pathogen exposure. This final rule also updates provisions in 

other rules that reference analytical methods and other requirements in the 1989 TCR (e.g., 

Public Notification and Ground Water Rules). These revisions are in accordance with the 1996

Safe Drinking Water Act (SDWA) Amendments, which require EPA to review and revise, as 

appropriate, each national primary drinking water regulation no less often than every six years. 

These revisions also conform with the SDWA provision that requires any revision to “maintain, 

Comment [JL1]: Mention that 

coliform exceedences are not longer 

considered violations of SDWA.

Comment [EPA2]: Added to address 

comment above.
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or provide for greater, protection of the health of persons.” As with the 1989 TCR, the RTCR 

applies to all public water systems.

DATES: This final rule is effective on [INSERT DATE 60 DAYS AFTER DATE OF 

PUBLICATION IN THE FEDERAL REGISTER]. For judicial purposes, this final rule is 

promulgated as of [INSERT DATE OF PUBLICATION IN THE FEDERAL REGISTER]. 

The compliance date for the rule requirements is [INSERT DATE THREE YEARS AFTER

PUBLICATION IN THE FEDERAL REGISTER]April 1, 2016. The incorporation by 

reference of certain publications listed in the rule is approved by the Director of the Federal 

Register (FR) as of [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE 

FEDERAL REGISTER].

ADDRESSES: EPA has established a docket for this action under Docket ID No. EPA-HQOW-2008-0878. All documents in the docket are listed on the http://www.regulations.gov

website. Although listed in the index, some information is not publicly available, e.g., 

Confidential Business Information (CBI) or other information whose disclosure is restricted by 

statute. Certain other material, such as copyrighted material, is not placed on the Internet and 

will be publicly available only in hard copy form. Publicly available docket materials are 

available either electronically through http://www.regulations.gov or in hard copy at the Water 

Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, DC. The 

Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 

legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the 

telephone number for the Water Docket is (202) 566-2426. 

FOR FURTHER INFORMATION CONTACT: Sean Conley, Standards and Risk 

Management Division, Office of Ground Water and Drinking Water (MC-4607M), 
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Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; 

telephone number: (202) 564-1781; e-mail address: conley.sean@epa.gov. For general 

information, contact the Safe Drinking Water Hotline, telephone number: (800) 426-4791. The 

Safe Drinking Water Hotline is open Monday through Friday, excluding legal holidays, from 10 

a.m. to 4 p.m. Eastern time.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Regulated Categories and Entities

Entities potentially regulated by the RTCR are all public water systems (PWSs). Regulated 

categories and entities include the following:

Category Examples of regulated entities

Industry Privately-owned community water systems 

(CWSs), transient non-community water 

systems (TNCWSs), and non-transient noncommunity water systems (NTNCWSs).

Federal, State, Tribal, and local governments Publicly-owned CWSs, TNCWSs, and 

NTNCWSs.

This table is not intended to be exhaustive, but rather provides a guide for readers regarding 

entities regulated by this action. This table lists the types of entities that EPA is now aware 

could potentially be regulated by this action. Other types of entities not listed in the table could 

also be regulated. To determine whether your facility is regulated by this action, you should 

carefully examine the definition of “public water system” in § 141.2 and the section entitled 

“Coverage” in § 141.3 in title 40 of the Code of Federal Regulations (CFR), and the applicability 

criteria in § 141.851(b) of this rule. If you have questions regarding the applicability of this 
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action to a particular entity, consult the person listed in the preceding “FOR FURTHER 

INFORMATION CONTACT” section. 

B. Copies of This Document and Other Related Information

This document is available for download at [INSERT WEBSITE ADDRESS]. For other 

related information, see preceding discussion on docket. EPA also prepared a Response to 

Comments Document that addresses the comments received during the comment period (to 

access this document, search for Docket ID No. EPA-HQ-OW-2008-0878 in 

www.regulations.gov).

C. Executive Summary

The Environmental Protection Agency (EPA) is finalizing the Revised Total Coliform Rule

(RTCR). The Revised Total Coliform Rule (RTCR) maintains the purpose of the 1989 Total 

Coliform Rule (TCR) to protect public health by ensuring the integrity of the drinking water 

distribution system and monitoring for the presence of microbial contamination. EPA anticipates 

greater public health protection under the RTCR, as it requires public water systems (PWSs) that 

are vulnerable to microbial contamination to identify and fix problems, and it establishes criteria 

for systems to qualify for and stay on reduced monitoring, thereby providing incentives for 

improved water system operation. 

The RTCR, as with the 1989 TCR, is the only microbial drinking water regulation that 

applies to all public water systemPWSs. Systems are required to meet a legal limit (i.e.,

maximum contaminant level (MCL)) for E. coli, as demonstrated by required monitoring. The 

RTCR specifies the frequency and timing of the microbial testing by water systems based on 

population served, system type, and source water type. The rule also requires public notification 

Comment [EPA3]: On 7/27, OMB 

asked that we include an executive 

summary. This text is as edited by 

OMB on 8/1 

Except for some editing of acronyms 

as indicated in track changes 

11/15/12.
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when there is a potential health threat as indicated by monitoring results, and when the system 

fails to identify and fix problems as required.

The entities potentially affected by the RTCR are public water systemPWSs that are 

classified as community water systems (CWSs) (e.g., systems that provide water to year-round 

residents in places like homes or apartment buildings) or non-community water systems 

(NCWSs) (e.g., systems that provide water to people in locations such as schools, office 

buildings, restaurants, etc.); State primacy agencies; and local and tribal governments. The 

RTCR applies to approximately 154,000155,000 PWSs that serve approximately 307310 million

(M) individuals. 

The RTCR establishes a health goal (maximum contaminant level goal, or MCLG) and an

MCL for E. coli, a more specific indicator of fecal contamination and potential harmful 

pathogens than total coliforms. EPA replaces the MCLG and MCL for total coliforms with a 

treatment technique for coliforms that requires assessment and corrective action. Many of the 

organisms detected by total coliform methods are not of fecal origin and do not have any direct 

public health implication. 

Under the treatment technique for coliforms, total coliforms serve as an indicator of a 

potential pathway of contamination into the distribution system. A PWS that exceeds a specified 

frequency of total coliform occurrence must conduct an assessment to determine if any sanitary 

defects exist (a sanitary defect is defined by the RTCR as a “defect that could provide a pathway 

of entry for microbial contamination into the distribution system or that is indicative of a failure 

or imminent failure of a barrier that is already in place”); if any are found, the system must 

correct them. In addition, under the treatment technique requirements, a PWS that incurs an E. 

coli MCL violation must conduct an assessment and correct any sanitary defects found. 

Comment [EPA4]: Changes made so 

that we are accurate but don’t have to 

be as precise with numbers that are 

always evolving. 

11/15/12 
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The RTCR links monitoring frequency to compliance monitoring results and system 

performance. It provides criteria that well-operated small systems must meet to qualify for and 

stay on reduced monitoring. It requires increased monitoring for high-risk small systems with 

unacceptable compliance history. It also requires some new monitoring requirements for 

seasonal systems (such as state and national parks).

The RTCR eliminates public notification requirements based only on the presence of total 

coliforms. Total coliforms in the distribution system may indicate a potential pathway for 

contamination but by themselves do not indicate a health threat. Instead, the RTCR requires 

public notification when an E. coli MCL violation occurs, indicating a potential health threat, or 

when a PWS fails to conduct the required assessment and corrective action.

EPA believes that the provisions of the RTCR will improve public health protection by 

requiring assessment and corrective action and providing incentives for improved operation. The 

estimated net incremental cost of the RTCR is $14 million annually at either a three or seven 

percent discount rate. This represents total increased costs relative to 1989 TCR provisions. 

PWSs are estimated to incur approximately 97 percent of the rule’s net annualized present value 

costs at athe three percent discount rate. States and other primacy agencies incur the remaining 

costs. 

Abbreviations Used in This Document 

ADWR Airline Drinking Water Rule

AGI Acute Gastrointestinal Illness

AIDS Acquired Immune Deficiency Syndrome

AIP Agreement in Principle

AWWA American Water Works Association

ATP Alternative Test Procedure

BAT Best Available Technology

C Celsius

Comment [EPA5]: More precise 

description of these conclusions. 

11/15/12
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CA Corrective Action

CBI Confidential Business Information

CCR Consumer Confidence Report

CDC Centers for Disease Control and Prevention

CFR Code of Federal Regulations

COI Cost of Illness

CWS Community Water System

DBPs Disinfection Byproducts

DWC Drinking Water Committee

EA Economic Analysis

EC E. coli

EC-MUG EC Medium with MUG

EPA United States Environmental Protection Agency

ERS Economic Research Service

ETV Environmental Technology Verification

FR Federal Register

GW Ground Water

GWR Ground Water Rule

GWS Ground Water System

GWUDI Ground Water Under the Direct Influence of Surface Water

HRRCA Health Risk Reduction and Cost Analysis

HUS Hemolytic Uremic Syndrome

ICR Information Collection Request

IESWTR Interim Enhanced Surface Water Treatment Rule

M Million

MCL Maximum Contaminant Level

MCLG Maximum Contaminant Level Goal 

mg/L Milligrams per Liter

ml Milliliters

MRDL Maximum Residual Disinfectant Level

MUG 4-methylumbelliferyl-Beta-D-glucuronide

NCWS Non-community Water System

NDWAC National Drinking Water Advisory Council 

NPDWR National Primary Drinking Water Regulation

NTNCWS Non-Transient Non-Community Water System

NTU Nephelometric Turbidity Unit

OMB Office of Management and Budget

O&M Operation and Maintenance

PN Public Notification

PWS Public Water System

RFA Regulatory Flexibility Act

RICP Research and Information Collection Partnership

RTCR Revised Total Coliform Rule

SAB Science Advisory Board

SBA Small Business Administration

SDWA Safe Drinking Water Act
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SDWIS Safe Drinking Water Information System

SDWIS/FED Safe Drinking Water Information System Federal Version

SOP Standard Operating Procedure

Stage 1 DBPR Stage 1 Disinfectants and Disinfection Byproducts Rule

Stage 2 DBPR Stage 2 Disinfectants and Disinfection Byproducts Rule

SW Surface Water

SWTR Surface Water Treatment Rule

TC Total Coliforms

TCR Total Coliform Rule

TCRDSAC Total Coliform Rule / Distribution System Advisory Committee

TMF Technical, Managerial, and Financial

TNCWS Transient Non-Community Water System

TWG Technical Work Group

T&C Technology and Cost

US United States

UV Ultraviolet Radiation

WRF Water Research Foundation

TABLE OF CONTENTS 

I. General Information

A. Regulated Categories and Entities

B. Copies of This Document and Other Related Information

B.C. Executive Summary

II. Background

A. Statutory Authority

B. Purpose of the Rule

C. Rule Development

1. Total Coliform Rule Distribution System Advisory Committee (TCRDSAC)

2. Stakeholder involvement 

D. Public Health Concerns Addressed by the Revised Total Coliform Rule

1. Public health concerns, fecal contamination, and waterborne pathogens

2. Indicators

3. Occurrence of fecal contamination and waterborne pathogens

III. Requirements of the Revised Total Coliform Rule

A. RTCR Definitions

1. Assessment

2. Clean compliance history

3. Sanitary defect

4. Seasonal systems

B. Rule Construct: MCLG and MCL for E. coli and Coliform Treatment Technique

1. MCLG and MCL

2. Coliform treatment technique

C. Monitoring

1. Requirements

2. Key issues raised
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D. Repeat samples

1. Requirements

2. Key issues raised

E. Coliform Treatment Technique 

1. Coliform treatment technique triggers

2. Assessment

3. Corrective action

F. Violations

1. Requirements

2. Key issues raised

G. Providing Notification and Information to the Public

1. Requirements

2. Key issues raised

H. Reporting and Recordkeeping

1. Requirements

2. Key issues raised

I. Analytical Methods

1. AIP-related method issues

2. Other method issues

J. Systems Under EPA Direct Implementation

K. Compliance Date

IV. Other Elements of the Revised Total Coliform Rule

A. Best Available Technology

1. Requirements

2. Key issues raised

B. Variances and Exemptions

1. Requirements

2. Key issues raised

C. Revisions to Other NPDWRs as a Result of the RTCR

D. Storage Facility Inspection 

V. State Implementation 

A. Primacy

1. Requirements

2. Key issues raised

B. State Recordkeeping and Reporting and SDWIS

1. Recordkeeping

2. Reporting

3. SDWIS

4. Key issues raised

VI. Economic Analysis (Health Risk Reduction and Cost Analysis) 

A. Regulatory Options Considered 

B. Major Sources of Data and Information Used in Supporting Analyses

1. Safe Drinking Water Information System Federal version data

2. Six-Year Review 2 data

3. Other information sources

C. Occurrence and Predictive Modeling
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1. Model used for PWSs serving ≤ 4,100 people

2. Model used for PWSs serving > 4,100 people

D. Baseline Profiles 

E. Anticipated Benefits of the RTCR

1. Relative risk analysis

2. Changes in violation rates and corrective actions

3. Nonquantifiable benefits 

F. Anticipated Costs of the RTCR 

1. Total annualized present value costs

2. PWS costs

3. State costs

4. Nonquantifiable costs

G. Potential Impact of the RTCR on Households 

H. Incremental Costs and Benefits 

I. Benefits from Simultaneous Reduction of Co-occurring Contaminants

J. Change in Risk from Other Contaminants

K. Effects of Fecal Contamination and/or Waterborne Pathogens on the General Population and 

Sensitive Subpopulations 

1. Risk to children, pregnant women, and the elderly

2. Risk to immunocompromised persons

L. Uncertainties in the Benefit and Cost Estimates for the RTCR

1. Inputs and their uncertainties

2. Sensitivity analysis

M. Benefit Cost Determination for the RTCR 

N. Comments Received in Response to EPA’s Requests for Comment

1. SAB’s concerns

2. Costs of major distribution system appurtenances

3. Annual monitoring and annual site visits

4. Effectiveness of assessments

O. Other Comments Received by EPA

1. Quantifying health benefits

2. Return to reduced monitoring

3. Shift of State resources

4. State burden

VII. Statutory and Executive Order Review

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

Improving Regulation and Regulatory Review

B. Paperwork Reduction Act

C. Regulatory Flexibility Act (RFA)

D. Unfunded Mandates Reform Act (UMRA)

E. Executive Order 13132: Federalism

F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments

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

Risks

H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or 

Use
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I. National Technology Transfer and Advancement Act

J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 

Populations and Low-Income Populations

K. Consultations with the Science Advisory Board, National Drinking Water Advisory Council, 

and the Secretary of Health and Human Services

L. Considerations of Impacts on Sensitive Subpopulations as Required by Section 

1412(b)(3)(C)(i)(V) of the 1996 Amendments of the Safe Drinking Water Act (SDWA)

M. Effect of Compliance with the RTCR on the Technical, Financial, and Managerial Capacity 

of Public Water Systems

N. Congressional Review Act

VIII. References

II. Background

A. Statutory Authority

The Safe Drinking Water Act (SDWA) requires the EPA to review and revise, as appropriate, 

each existing national primary drinking water regulation (NPDWR) no less often than every six 

years (SDWA section 1412(b)(9), 42 U.S.C. 300g-1(b)(9)). In 2003, EPA completed its review 

of the 1989 TCR (USEPA 1989a, 54 FR 27544, June 29, 1989) and 68 NPDWRs for chemicals 

that were promulgated prior to 1997 (USEPA 2003, 68 FR 42908, July 18, 2003). The purpose 

of the review was to identify new health risk assessments, changes in technology, and other 

factors that would provide a health-related or technological basis to support a regulatory revision 

that would maintain or improve public health protection. In the Six-Year Review 1 

determination published in July 2003 (USEPA 2003, 68 FR 42908, July 18, 2003), EPA stated 

its intent to revise the 1989 TCR. 

B. Purpose of the Rule

EPA promulgated the 1989 TCR to decrease the risk of waterborne illness. Among all 

SDWA rules promulgated for preventing waterborne illness, only the TCR applies to all PWSs, 

making the rule an essential component of the multi-barrier approach in public health protection 

against endemic and epidemic disease. In combination with the other SDWA rules (e.g., the 
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Ground Water Rule (GWR) (USEPA 2006c, 71 FR 65574, November 8, 2006) and the suite of 

surface water treatment rules (USEPA 1989b; USEPA 1998b; USEPA 2002; USEPA 2006d)), 

the RTCR will better address the 1989 TCR objectives and enhance the multi-barrier approach to 

protecting public health, especially with respect to small ground water PWSs. 

In recent years, the number of violations under the 1989 TCR have remained relatively 

steady, as shown and discussed in Exhibit 4.11 and Appendix G of the Economic Analysis for the 

Final Revised Total Coliform Rule (RTCR EA) (USEPA 2012a). EPA believes that this is 

reflective of a steady state among PWSs complying with the 1989 TCR and any improvements 

likely to occur under that rule have largely been achieved. In outlining recommendations for 

further reductions in occurrence, EPA and the Total Coliform Rule Distribution System 

Advisory Committee (TCRDSAC) developed an Agreement in Principle (AIP) (USEPA 2008c),

which became the basis of the proposed and final RTCR. See section II.C.1 of this preamble, 

Total Coliform Distribution System Advisory Committee (TCRDSAC), for more information 

about the TCRDSAC and the AIP.

The RTCR aims for greater public health protection than the 1989 TCR in a cost-effective 

manner by: (1) maintaining the objectives of the 1989 TCR (i.e., to evaluate the effectiveness of 

treatment, to determine the integrity of the distribution system, and to signal the possible 

presence of fecal contamination); (2) reducing the potential pathways of contamination into the 

distribution system (see section II.D of this preamble, Public Health Concerns Addressed by the 

Revised Total Coliform Rule); (3) using the optimal indicator for the intended objectives (i.e., 

using total coliforms as an indicator of system operation and condition rather than an immediate 

public health concern and using E. coli as a fecal indicator (see sections II.D, Public Health 

Concerns Addressed by the Revised Total Coliform Rule, and III.B, Rule Construct: MCLG and 
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MCL for E. coli and Coliform Treatment Technique, of this preamble)); (4) requiring more 

stringent standards than those of the 1989 TCR for systems to qualify for reduced monitoring 

(see sections III.C.1.b.iii, Reduced monitoring, and III.C.1.c.iii, Reduced monitoring, of this 

preamble); and (5) requiring that systems that may be vulnerable to contamination, as indicated 

by their monitoring results and by the nature of their operation (e.g., seasonal systems), to 

monitor more frequently and have in place procedures that will minimize the incidence of 

contamination (e.g., requiring start-up procedures for seasonal systems) (see sections III.C.1.b.iv, 

Increased monitoring, III.C.1.c.iv, Requirements for returning to monthly monitoring, and 

III.C.1.f, Seasonal systems, of this preamble). EPA, therefore, anticipates greater public health 

protection under the RTCR compared to the 1989 TCR because of the RTCR’s more preventive 

approach to identifying and fixing problems that affect or may affect public health. 

C. Rule Development

1. Total Coliform Rule Distribution System Advisory Committee (TCRDSAC)

The revisions to the 1989 TCR are primarily based on the recommendations of the Total 

Coliform Rule Distribution System Advisory Committee (“TCRDSAC” or the “advisory 

committee”). EPA established the TCRDSAC in June 2007 in accordance with the provisions of 

the Federal Advisory Committee Act, 5 U.S.C. App.2, 9(c), to provide recommendations to EPA 

on revisions to the 1989 TCR and on what information about distribution system issues is needed 

to better understand and address possible public health impacts from potential degradation of 

drinking water quality in distribution systems (USEPA 2007a, 72 FR 35869, June 29, 2007). 

All advisory committee members agreed to a set of recommendations and signed a final 

Agreement in Principle (AIP) in September 2008. Pursuant to the AIP, EPA on July 14, 2010 

proposed revisions to the 1989 TCR (USEPA 2010a, 75 FR 40926, July 14, 2010) that, to the 

Comment [JL6]: Are there any 

provisions in the rule that are different 

from or in addition to the AIP?

Comment [EPA7]: The provisions of 

the final RTCR are largely consistent 

with the recommendations in the AIP 

and the proposed rule, but some 

requirements have been revised for the 

final RTCR based on comments 

received and further agency 

deliberation. The requirements that 

were revised for the final rule include:

•The definition of a seasonal system 

and requirements for seasonal 

systems were revised. 

•The requirements for increased 

monitoring for non-community water 

systems were revised. 

•Added that States can waive the 24 

hour time limit for invalidated or 

repeat sampling based on criteria 

instead of case by case. 

Definitions of level 1 and level 2 

assessments were added
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maximum extent consistent with EPA’s legal obligations, had the same substance and effect as 

the elements of the AIP. The AIP and details about the advisory committee can be found at 

EPA’s website at 

http://water.epa.gov/lawsregs/rulesregs/sdwa/tcr/regulation_revisions_tcrdsac.cfm.

2. Stakeholder involvement

In accordance with one of the recommendations of the TCRDSAC, EPA held two annual 

stakeholder meetings, prior to publishing the proposed revisions, to which all advisory 

committee members and the public at large were invited. In April 2009 and May 2010, EPA 

held these stakeholder meetings to provide updates and an opportunity for stakeholders to 

provide feedback on the development of a proposed RTCR that had the same substance and 

effect as the recommendations in the AIP.

EPA proposed the RTCR on July 14, 2010 (USEPA 2010a, 75 FR 40926, July 14, 2010) and 

requested public comment. EPA received approximately 150 comment letters on the proposal 

and considered the comments in making revisions to the final RTCR. Key issues raised by the 

commenters are discussed in their corresponding sections of this preamble. A Response to 

Comments Document is available in the docket of the RTCR (search for Docket ID No. EPAHQ-OW-2008-0878 in www.regulations.gov).

During the public comment period for the proposed RTCR, EPA also held several meetings

to solicit and provide the public with information about the provisions of the proposed rule.

In addition to consulting with the advisory committee and holding stakeholder meetings, EPA 

consulted with specific stakeholders such as the National Drinking Water Advisory Council

(NDWAC), the Science Advisory Board (SAB), and Tribal representatives, among others. These 
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consultations are discussed in section VII of this preamble, Statutory and Executive Order 

Review.

D. Public Health Concerns Addressed by the Revised Total Coliform Rule

1. Public health concerns, fecal contamination, and waterborne pathogens

The RTCR aims to increase public health protection through the reduction of potential 

pathways of entry for fecal contamination into the distribution system. Since these potential 

pathways represent vulnerabilities in the distribution system whereby fecal contamination and/or 

waterborne pathogens, including bacteria, viruses and parasitic protozoa could possibly enter the 

system, the reduction of these pathways in general should lead to reduced exposure and 

associated risk from these contaminants. Fecal contamination and waterborne pathogens can 

cause a variety of illnesses, including acute gastrointestinal illness (AGI) with diarrhea, 

abdominal discomfort, nausea, vomiting, and other symptoms. Most AGI cases are of short 

duration and result in mild illness. Other more severe illnesses caused by waterborne pathogens 

include hemolytic uremic syndrome (HUS) (kidney failure), hepatitis, and bloody diarrhea 

(WHO 2004). Chronic disease such as irritable bowel syndrome, renal impairment, 

hypertension, cardiovascular disease and reactive arthritis can result from infection by a 

waterborne agent (Clark et al. 2008; Clark et al. 2010; Moorin et al. 2010).

When humans are exposed to and infected by waterborne enteric pathogens, the pathogens 

become capable of reproducing in the gastrointestinal tract. As a result, healthy humans shed 

pathogens in their feces for a period ranging from days to weeks. This shedding of pathogens 

often occurs in the absence of any signs of clinical illness. Regardless of whether a pathogen 

causes clinical illness in the person who sheds it in his or her feces, the pathogen being shed may 

infect other people directly by person-to-person spread, contact with contaminated surfaces, and 
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other means referred to as secondary spread. As a result, waterborne pathogens that are initially 

waterborne may subsequently infect other people through a variety of routes (WHO 2004). 

Sensitive subpopulations are at greater risk from waterborne disease than the general population 

(Gerba et al. 1996). For a discussion of sensitive subpopulations, see section VII.L of this 

preamble, Impacts on Sensitive Subpopulations as Required by Section 1412(b)(3)(c)(i)(V) of the 

1996 Amendments of the Safe Drinking Water Act (SDWA).

2. Indicators

Total coliforms are a group of closely related bacteria that, with a few exceptions, are not 

harmful to humans. Coliforms are abundant in the feces of warm-blooded animals, but can also 

be found in aquatic environments, in soil, and on vegetation. Coliform bacteria may be 

transported to surface water by run-off or to ground water by infiltration. Total coliforms are 

common in ambient water and may be injured by environmental stresses such as lack of 

nutrients, and water treatments such as chlorine disinfection, in a manner similar to most 

bacterial pathogens and many viral enteric pathogens (including fecal pathogens). EPA 

considers total coliforms to be a useful indicator that a potential pathway exists through which 

fecal contamination can enter the distribution system. This is because the absence (versus the 

presence) of total coliforms in the distribution system indicates a reduced likelihood that fecal 

contamination and/or waterborne pathogens are occurring in the distribution system.

Under the 1989 TCR, each total coliform-positive sample is assayed for either fecal 

coliforms or E. coli. Fecal coliform bacteria are a subgroup of total coliforms that traditionally 

have been associated with fecal contamination. Since the promulgation of the 1989 TCR, more 

information and understanding of the suitability of fecal coliform and E. coli as indicators have 

become available. Study has shown that the fecal coliform assay is imprecise and too often 
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captures bacteria that do not originate in the human or mammal gut (Edberg et al. 2000). On the 

other hand, E. coli is a more restricted group of coliform bacteria that almost always originate in 

the human or animal gut (Edberg et al. 2000). Thus, E. coli is a better indicator of fecal 

contamination than fecal coliforms. The provisions of the RTCR reflect the improved 

understanding of the value of total coliforms and E. coli as indicators.

3. Occurrence of fecal contamination and waterborne pathogens

a. Presence of fecal contamination. Fecal contamination is a very general term that 

includes all of the organisms found in feces, both pathogenic and nonpathogenic. Fecal 

contamination can occur in drinking water both through use and inadequate treatment of 

contaminated source water as well as direct intrusion of fecal contamination into the drinking 

water distribution system. Lieberman et al. (1994) discuss the general association between fecal 

contamination and waterborne pathogens. Biofilms in distribution systems may harbor 

waterborne bacterial pathogens and accumulate enteric viruses and parasitic protozoa (Skraber et 

al. 2005; Helmi et al. 2008). Waterborne pathogens in biofilms may have entered the 

distribution system as fecal contamination from humans or animals.

Co-occurrence of indicators and waterborne pathogens is difficult to measure. While the 

analytical methods approved by EPA to assay for E. coli are able to detect indicators of fecal 

contamination, they do not specifically identify most of the pathogenic E. coli strains. There are 

at least 700 recognized E. coli strains (Kaper et al. 2004) and about 10 percent of recognized E. 

coli strains are pathogenic to humans (Feng 1995; Hussein 2007; Kaper et al. 2004). Pathogenic 

E. coli include E. coli O157:H7, which is the primary cause of HUS in the United States (Rangel 

et al. 2005). The US Centers for Disease Control and Prevention (CDC) estimates that there are 

73,000 cases of illness each year in the US due to E. coli O157:H7 (Mead et al. 1999). The CDC 
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estimates that about 15 percent of all reported E. coli O157:H7 cases are due to water 

contamination (Rangel et al. 2005). Active surveillance by CDC shows that 6.3 percent of E. 

coli O157:H7 cases progress to HUS (Griffin and Tauxe 1991; Gould et al. 2009) and about 12 

percent of HUS cases result in death within four years (Garg et al. 2003). About 4 to 15 percent 

of cases are transmitted within households by secondary transmission (Parry and Salmon 1998).

Because EPA-approved standard methods for E. coli do not typically identify the presence of 

the pathogenic E. coli strains, an E. coli-positive monitoring result is an indicator of fecal 

contamination but is not necessarily a measure of waterborne pathogen occurrence. Specialized 

assays and methods are used to identify waterborne pathogens, including pathogenic E. coli.

One notable exception is the data reported by Cooley et al. (2007), which showed high 

concentrations of pathogenic E. coli strains in samples containing high concentrations of fecal 

indicator E. coli. These data are from streams and other poor quality surface waters surrounding 

California spinach fields associated with the 2006 E. coli O157:H7 foodborne outbreak. Data 

equivalent to these samples are not available from drinking water samples collected under the 

1989 TCR.

Because E. coli is an indicator of fecal contamination (Edberg et al. 2000), and because of 

the general association between fecal contamination and waterborne pathogens (Lieberman et al. 

1994; Lieberman et al. 2002), E. coli is a meaningful indicator for fecal contamination and the 

potential presence of associated pathogen occurrence.

b. Waterborne disease outbreaks. The CDC defines a waterborne disease outbreak as 

occurring when at least two persons experience a similar illness after ingesting a specific 

drinking water (or after exposure to recreational water) contaminated with pathogens (or 

chemicals) (Kramer et al. 1996), or when one person experiences amoebic meningoencephalitis 
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after similar waterborne exposure. The CDC maintains a database on waterborne disease 

outbreaks in the United States. The database is based upon responses to a voluntary and 

confidential survey form that is completed by State and local public health officials.

The National Research Council strongly suggests that the number of identified and reported 

outbreaks in the CDC database for surface and ground waters represents only a small percentage 

of the actual number of waterborne disease outbreaks (NRC 1997; Bennett et al. 1987; Hopkins 

et. al. 1985 for Colorado data). Under-reporting occurs because most waterborne outbreaks in 

community water systems are not recognized until a sizable proportion of the population is ill 

(Perz et al. 1998; Craun 1996), perhaps 1 percent to 2 percent of the population (Craun 1996).

EPA drinking water regulations are designed to protect against endemic waterborne disease and 

to minimize waterborne outbreaks. In contrast to epidemic outbreaks, endemic disease refers to 

the persistent low to moderate level or the usual ongoing occurrence of illness in a given 

population or geographic area (Craun et al. 2006).

III.Requirements of the Revised Total Coliform Rule

The RTCR maintains and strengthens the objectives of the 1989 TCR and is consistent with 

the recommendations in the AIP. The objectives are: (1) to evaluate the effectiveness of 

treatment, (2) to determine the integrity of the distribution system, and (3) to signal the possible 

presence of fecal contamination. The RTCR better addresses these objectives by requiring 

systems that may be vulnerable to fecal contamination (as indicated by their monitoring results) 

to do an assessment, to identify whether any sanitary defect(s) is (are) present, and to correct the 

defects. Therefore, the Agency anticipates greater public health protection under the RTCR 

compared to the 1989 TCR because of its more preventive approach to identifying and fixing 
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problems that affect or may affect public health. The following is an overview of the key 

provisions of the RTCR:

• MCLG and MCL for E. coli and coliform treatment technique for protection against potential 

fecal contamination. The RTCR establishes a maximum contaminant level goal (MCLG) and 

maximum contaminant level (MCL) for E. coli. Under the RTCR there is no longer a monthly 

maximum contaminant level (MCL) violation for multiple total coliform detections. The RTCR 

It takes a preventive approach to protecting public health by establishing a coliform treatment 

technique for protection against potential fecal contamination. The treatment technique uses 

both total coliforms and E. coli monitoring results to start an evaluation process that, where 

necessary, requires the PWS to conduct follow-up corrective action that could prevent future 

incidences of contamination and exposure to fecal contamination and/or waterborne pathogens. 

See section III.B of this preamble, Rule Construct: MCLG and MCL for E. coli and Coliform 

Treatment Technique, for further discussion on the MCLG, MCL, and treatment technique 

requirements.

• Monitoring. As with the 1989 TCR, PWSs will continue to monitor for total coliforms and 

E. coli according to a sample siting plan and schedule specific to the system. 

Sample siting plans under the RTCR must continue to be representative of the water 

throughout the distribution system. Under the RTCR, systems have the flexibility to propose 

repeat sample locations that best verify and determine the extent of potential contamination of 

the distribution system rather than having to sample within five connections upstream and 

downstream of the total coliform-positive sample location. In lieu of proposing new repeat 

sample locations, the systems may stay with the default used under the 1989 TCR of within-fiveconnections-upstream-and-downstream of the total coliform-positive sample location. 

Comment [JL8]: Clarify that TC 

exceedences per se no longer 

constitute a violation, as long as TT is 

complied with.

Comment [EPA9]: Added to address 

comment above.
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As with the 1989 TCR, the RTCR allows reduced monitoring for some small ground water 

systems. The RTCR is expected to improve public health protection compared to the 1989 TCR 

by requiring small ground water systems that are on or wish to conduct reduced monitoring to 

meet certain eligibility criteria. Examples of the criteria include a sanitary survey showing that 

the system is free of sanitary defects, a clean compliance history for 12 months, and a recurring 

annual site visit by the State and/or a voluntary Level 2 assessment for systems on annual 

monitoring.

For small ground water systems, the RTCR requires increased monitoring for high-risk 

systems such as those that do not have a clean compliance history under the RTCR. The RTCR 

specifies conditions under which systems will no longer be eligible for reduced monitoring and 

be required to return to routine monitoring or to monitor at an increased frequency.

The RTCR requires systems on a quarterly or annual monitoring frequency (applicable only 

to ground water systems serving 1,000 or fewer people) to collect at least three additional routine 

monitoring samples the month following one or more total coliform-positive samples, unless the 

State waives the additional routine monitoring. This is a reduction in the required number of 

additional routine samples from the 1989 TCR, which requires at least five routine samples in the 

month following a total coliform-positive sample for all systems serving 4,100 or fewer people.

The 1989 TCR requires all systems serving 1,000 or fewer people to collect at least four 

repeat samples while requiring PWSs serving 1,000 people or greater to collect three repeat 

samples. The RTCR requires three repeat samples after a routine total coliform-positive sample, 

regardless of the system type and size. 

See sections III.C, Monitoring, and III.D, Repeat Samples, of this preamble for detailed 

discussions of the routine monitoring and repeat sampling requirements of the RTCR.
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• Seasonal systems. For the first time, the RTCR establishes monitoring requirements specific 

to seasonal systems. Seasonal systems represent a special case in that the shutdown and start-up 

of these water systems present additional opportunities for contamination to enter or spread 

through the distribution system. Under the RTCR, seasonal systems must demonstrate 

completion of a State-approved start-up procedure. See sections III.A.4, Seasonal systems, and 

III.C.1.f, Seasonal systems, of this preamble for further discussion of requirements for seasonal 

systems.

• Assessment and corrective action. As part of a treatment technique, all PWSs are required to 

assess their systems when monitoring results show that the system may be vulnerable to 

contamination. Systems must conduct either a Level 1 assessment or a more detailed Level 2 

assessment depending on the severity and frequency of contamination level of concern raised by 

the results of indicator sampling. The system is responsible for correcting any sanitary defect(s) 

found through either a Level 1 or Level 2 assessment. See section III.E of this preamble, 

Coliform Treatment Technique, for more discussion of the treatment technique requirement of 

the RTCR.

• Violations and public notification. The RTCR establishes an E. coli MCL violation, a 

treatment technique violation, a monitoring violation, and a reporting violation. Public 

notification is required for each type of violation, with the type of notification dependent on the 

degree of potential public health concern. This is consistent with EPA’s current public 

notification requirements under 40 CFR part 141 subpart Q. The RTCR also modifies the public 

notification and Consumer Confidence Report language to reflect the construct of the rule. See 

sections III.F, Violations, and III.G, Providing Notification and Information to the Public, of this 

preamble for further discussions of violations and public notification under the RTCR.
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• Transition to the RTCR. The RTCR allows all systems to transition to the new rule at their 

1989 TCR monitoring frequency, including systems on reduced monitoring under the 1989 TCR. 

For ground water systems serving 1,000 or fewer people, States must conduct a special

monitoring evaluation during each sanitary survey after the compliance effective date of the 

RTCR. This process Initial grandfathering of monitoring frequencies reduces State burden by 

not requiring the State to determine appropriate monitoring frequency at the same time as when

the State is trying working to adopt primacy, develop policies, and train their own staff and the 

PWSs in the State. 

The provisions of the RTCR are contained in the new 40 CFR part 141 subpart Y, 

superseding 40 CFR 141.21 beginning [INSERT DATE THREE YEARS AFTER 

PUBLICATION IN THE FEDERAL REGISTER]April 1, 2016.

A. RTCR Definitions

1. Assessment 

a. Provisions. EPA is defining a Level 1 assessment and a Level 2 assessment to help in the 

implementation of the RTCR and to better differentiate between the two levels of assessments.

A Level 1 assessment is an evaluation to identify the possible presence of sanitary defects, 

defects in distribution system coliform monitoring practices, and (when possible) the likely 

reason that the system triggered the assessment. It is conducted by the system operator or owner 

(or his designated representative). Minimum elements include review and identification of 

atypical events that could affect distributed water quality or indicate that distributed water 

quality was impaired; changes in distribution system maintenance and operation that could affect 

distributed water quality (including water storage); source and treatment considerations that bear 

on distributed water quality, where appropriate (e.g., whether a ground water system is 
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disinfected); existing water quality monitoring data; and inadequacies in sample sites, sampling 

protocol, and sample processing. The system must conduct the assessment consistent with any 

State directives that tailor specific assessment elements with respect to the size and type of the 

system and the size, type, and characteristics of the distribution system.

A Level 2 assessment is an evaluation to identify the possible presence of sanitary defects, 

defects in distribution system coliform monitoring practices, and (when possible) the likely 

reason that the system triggered the assessment. A Level 2 assessment provides a more detailed 

examination of the system (including the system’s monitoring and operational practices) than 

does a Level 1 assessment through the use of more comprehensive investigation and review of 

available information, additional internal and external resources, and other relevant practices. It

is conducted by an individual approved by the State, which may include the system operator. 

Minimum elements include review and identification of atypical events that could affect 

distributed water quality or indicate that distributed water quality was impaired; changes in 

distribution system maintenance and operation that could affect distributed water quality 

(including water storage); source and treatment considerations that bear on distributed water 

quality, where appropriate (e.g., whether a ground water system is disinfected); existing water 

quality monitoring data; and inadequacies in sample sites, sampling protocol, and sample 

processing. The system must conduct the assessment consistent with any State directives that 

tailor specific assessment elements with respect to the size and type of the system and the size, 

type, and characteristics of the distribution system. The system must comply with any expedited 

actions or additional actions required by the State in the case of an E. coli MCL violation.

b. Key issues raised. EPA did not propose definitions for Level 1 and Level 2 assessments. 

However, based on the comments EPA received, there was concern that the distinction between 

Comment [JL10]: Other than saying 

it is “more detailed” and “more 

comprehensive” this definition gives 

no info on what additional elements 

need to be included in a level 2 

assessment, or specifically how it 

differs from a level 1 assessment.

Comment [EPA11]: See section 

III.E.2.b for a more detailed 

discussion of the differences between 

the two assessments. (pages 73-82)

Comment [EPA12]: Also related to 

JL comment above, this is specific to 

a level 2 assessment.
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the two levels of assessment is not sufficiently laid out in the rule language. This might pose 

some problems in the implementation of the RTCR. In response, EPA is defining a Level 1 

assessment and a Level 2 assessment. This issue and the RTCR requirements regarding 

assessments are discussed further in section III.E.2 of this preamble, Assessment.

2. Clean compliance history

a. Provisions. In the final RTCR, EPA is defining “clean compliance history” as a record of 

no maximum contaminant level (MCL) violations under 40 CFR 141.63; no monitoring 

violations under 40 CFR 141.21 or subpart Y; and no coliform treatment technique trigger 

exceedances or coliform treatment technique violations under subpart Y. This is the same 

definition that the advisory committee recommended in the AIP and that EPA proposed in July 

2010 (USEPA 2010a, 75 FR 40926, July 14, 2010). The term is specific to RTCR compliance 

and is used to determine eligibility of systems for reduced monitoring. It does not include 

violations under other existing NPDWRs. Systems must have a “clean compliance history” for a 

minimum of 12 months to qualify for reduced monitoring (see sections III.C.1.b.iii, Reduced 

monitoring, and III.C.1.c.iii, Reduced monitoring, of this preamble regarding reduced 

monitoring).

However, while the definition of “clean compliance history” includes only 1989 TCR/RTCR 

violations, the State may (and should) consider compliance history under other rules if relevant. 

For example, failure to take a triggered source water sample required under the GWR (USEPA 

2006, 71 FR 65574, November 8, 2006) may appropriately cause the State to not allow less 

frequent monitoring because this cwould (1) lead the system to miss source water contamination 

and (2) indicate a system’s lack of attention to regulatory requirements or proper operation.or

which could lead it to could miss source water contamination.

Comment [JL13]: Over what time 

period?

Comment [EPA14]: The time period 

(12 months) is not in the definition but 

is in the conditions for reduced 

monitoring, Inserted below.

Comment [EPA15]: Language as 

edited by Jim was: “...because this 

could indicate a systems’ lack of 

attention to requirements, which could 

lead it to miss source water 

contamination.” We’d like to modify 

the suggested language to read as 

indicated.
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There may also be instances where a system with a treatment technique violation under the 

GWR will also cease to have a clean compliance history under the RTCR. One scenario is when 

a small system’s dual-purpose sample is E. coli-positive. According to § 141.853(a)(5)(ii), the 

system has an MCL violation under the RTCR and is required to comply with the treatment 

technique requirements of the GWR. Failing to comply with the GWR treatment technique 

requirements (in this case, complete corrective actions to address the cause of the E. coli-positive 

sample according to a State-approved plan and schedule) results in a GWR treatment technique 

violation. The system, therefore, has a treatment technique violation under the GWR and ceases

to have a clean compliance history under the RTCR (because of the MCL violation).

b. Key issues raised. EPA received comments that a record of no monitoring violations 

should not be included in the definition of “clean compliance history.” Commenters are 

concerned that small systems, which experience frequent turnover or shortage of staff, may not 

be able to qualify for reduced monitoring if they miss a sample or two. EPA believes that a 

system on a reduced monitoring frequency (i.e., less than monthly, either quarterly or annually) 

must be able to demonstrate that it is capable of delivering safe water and maintaining proper 

attention to the water system, even on an infrequent monitoring schedule, by meeting certain 

criteria (see sections III.C.1.b.iii, Reduced monitoring, and III.C.1.c.iii, Reduced monitoring, of 

this preamble on for discussion about the reduced monitoring criteria). Small systems 

monitoring less frequently than monthly, especially those monitoring only annually, already have 

a lower probability of detecting a contamination event compared to systems that monitor 

monthly. Because of the intermittent nature of contamination and the fact that these systems are 

already on a significantly reduced monitoring frequency, it is very important that these systems 

take their samples as required. Because these systems monitor so infrequently, EPA 

Comment [JL16]: This para is 

confusing, not clear that it is needed. 

The system loses its clean compliance 

history regardless of whether it does 

GWR corrective action or not, no? 

Only relevant factor is RTCR MCL 

violation. Why confuse the issue by 

bringing in the GWR?

Comment [EPA17]: Agree, deleted.
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recommends that the States use the annual site visits as an opportunity to review system 

operations, reinforce the importance of collecting the required samples, and to identify and 

require correction of any sanitary defects. The State can make sure that the system takes its

required sample, and therefore avoids incurring a monitoring violation because of a missed 

sample (see section III.C.1.b.iii of this preamble, Reduced monitoring, on for discussion of 

annual monitoring). EPA is therefore retaining the definition of “clean compliance history” as 

proposed because EPA believes that removing the record of no monitoring violation from the 

definition would be less protective of public health. However, EPA is providing flexibility to the 

States in considering monitoring violations in TNCWSs in the context of when determining 

whether the system must go on reduced and increased frequency ofmonthly monitoring. See 

sections III.C.1.b, Ground water NCWSs serving ≤ 1,000 people, and III.C.2.b, Ground water 

NCWSs serving ≤ 1,000 people, of this preamble for a more detailed discussion.

3. Sanitary defect

a. Provisions. EPA is finalizing the definition of sanitary defect as proposed in July 2010

(USEPA 2010a, 75 FR 40926, July 14, 2010). It is defined as a “defect that could provide a 

pathway of entry for microbial contamination into the distribution system or that is indicative of 

a failure or imminent failure in a barrier that is already in place.” As stated in the proposed rule, 

the first part of the definition focuses on the problems in the distribution system that may provide 

a pathway for contaminants to enter the distribution system and its implication for potential 

exposure to both microbial and chemical contaminants. The second part of the definition also 

recognizes the importance of having barriers in place to prevent the entry of microbial 

contaminants into the distribution system. Indications of failure or imminent failure of these 

barriers are defects that require corrective action.

Comment [JL18]: Does this mean 

they could have a clean compliance 

history even with a missed sample? 

Please clarify.

Comment [EPA19]: Edited to read as 

indicated. They do not have a clean 

compliance history, and they still have 

a monitoring violation, but the State 

may elect not to count the missed 

sample toward the requirement to 

increase monitoring. With a record of 

a monitoring violation, and therefore 

lack of clean compliance history, the 

TNCWS could not qualify for reduced 

annual monitoring.
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The advisory committee deliberated on the definition of sanitary defect and suggested that 

the definition should be broad enough to facilitate corrective action without absolute 

confirmation of cause and effect, as such confirmation may be impossible or may significantly 

delay corrections that would address a sanitary defect that represents a potential threat to public 

health. Similarly Conversely, the language is not intended to be so open to interpretation suggest

that corrections are must be undertaken or required where the linkage between the defect and 

public health is tenuous. The advisory committee also agreed that it is their intent that nothing in 

the definition of sanitary defects precludes conducting an assessment of every element on the 

example checklists for Level 1 and Level 2 assessments (USEPA 2008d).

b. Key issues raised. EPA received comments regarding the relationship between sanitary 

defects under the RTCR and “significant deficiencies’ under other regulations and the possible 

confusion between the two terms. One commenter said that the requirement to identify and 

correct sanitary defects under the RTCR is very similar to the GWR’s requirement to identify 

and correct significant deficiencies, and that EPA should therefore consider which rule is more 

effective at minimizing risk of contamination. 

The advisory committee specifically stated that “sanitary defects” are specific to the 

assessment and corrective action requirements of the RTCR and are not intended to be linked 

directly to “significant deficiencies” under the Interim Enhanced Surface Water Treatment Rule 

(IESWTR) (USEPA 1998, 63 FR 69389, December 16, 1998) and the GWR, although some 

problems could meet either definition. The term “significant deficiency” is tied or associated 

with the eight elements of a sanitary survey. Accordingly, tThere are problems that are “sanitary 

defects” and are also “significant deficiencies” and vice versa. For instance, source water 

problems like those associated with the well casing may fit the definition of both a “sanitary 
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defect” and a “significant deficiency.” Depending on when the problem was identified (i.e., 

during a sanitary survey or during an assessment triggered under RTCR) and on the guidelines 

set by the State, the system should coordinate with their State regarding how to characterize the 

problem and how to coordinate the corrective action requirements under the GWR and RTCR, if 

needed. Conversely, there are problems that are “sanitary defects” but are not “significant 

deficiencies” and vice versa. “Significant deficiency” can include problems other than those in 

the distribution system that can have an effect on the long term viability of the system in 

delivering safe water to its customers. “Significant deficiencies” can also exist in the areas of 

reporting and data verification, system management and operation, and operator compliance with 

State requirements, which are not considered “sanitary defects.” 

Furthermore, although there might be overlap between a “sanitary defect” and “significant 

deficiency,” there are differences in the required timeframes for responding to them (see 40 CFR 

141.403(a)(5) and 142.16(b)(1)(ii), and §§ 141.859(b)(3) and (b)(4) of the RTCR). It might 

therefore be more confusing to use only one term for the requirements of the GWR and RTCR, 

as suggested by some commenters. 

In addition, the GWR only applies to ground water systems. Relying only on the corrective 

action provisions of the GWR (triggered by a fecal indicator-positive sample) will leave out 

those systems not covered by the GWR. Also, these GWR provisions are focused on the source 

water. Since contamination is intermittent and can be from a location other than the source 

water, the assessment and corrective action provisions in the RTCR will help to better address 

existing other types of defects and deficiencies. 

As noted in the preamble to the proposed RTCR, nothing in the RTCR is intended to limit the 

existing authorities of States under other regulations.

Comment [JL20]: Best to stick with 

the RTCR terminology.

Comment [EPA21]: OK
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4. Seasonal systems

a. RequirementsProvisions. EPA is finalizing the definition of seasonal system as “a noncommunity water system that is not operated on a year-round basis and starts up and shuts down 

at the beginning and end of each operating season.”

The advisory committee recognized that seasonal systems have unique characteristics that 

make them susceptible to contamination. As their name implies, seasonal systems are not 

operated year-round. The depressurizing and dewatering of the water system, as often occurs 

with the temporary shutdown of the system, present opportunities for contamination to enter or 

spread through the distribution system. For example, loss of pressure after a system’s shutdown 

can lead to intrusion of contaminants. Even a system that remains pressurized may be subject to 

water quality degradation due to stagnant water or loss of disinfectant residual. Microbial 

growth prior to start-up can result in biofilm formation, which can lead to the accumulation of 

contaminants. These systems are also more susceptible to contamination due to changes in the 

conditions of the source water (such as variable contaminant loading due to increased septic tank 

or septic field use), the seasonal nature of the demand, and the stress that the system experiences. 

As a result, the Agency is establishing a definition for seasonal systems and setting forth 

provisions that mitigate the risk associated with the unique characteristics of this type of system 

(see section III.C.1.f of this preamble, Seasonal systems, for requirements for seasonal systems). 

The advisory committee recommended that such provisions pertain to seasonal systems.

The definition of seasonal system that EPA is promulgating with this final rule is different 

from the definition proposed in July 2010 (USEPA 2010a, 75 FR 40926, July 14, 2010), which is 

“a non-community water system that is operated in three or fewer calendar quarters per calendar 

year.” As discussed in the preamble to the proposed rule, EPA was aware of the limitations of 

Comment [EPA22]: Definition of 

seasonal system – see Jim’s comment 

below.

Comment [JL23]: Need to state 

somewhere here what the new 

definition is.

Comment [EPA24]: At the beginning 

of this section, on the previous page.
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the proposed definition that could lead to less public health protection and less effective and 

more complicated implementation. EPA gave the example of a system that is operated from 

March to October. Such a system would operate in all four calendar quarters and therefore 

would not be considered a seasonal system according to the proposed definition, but would 

nonetheless be subject to the same possibility of distribution system contamination as a seasonal 

system operated from April to November (i.e., in only three calendar quarters). To address 

limitations such as this, EPA specifically requested comment on the proposed definition of a 

seasonal system. The change in the definition from the proposed rule is based on the comments 

received. Specific requirements (e.g., monitoring, start-up procedure, etc.) for seasonal systems 

that address the issues associated with such systems are discussed in section III.C.1.f, Seasonal 

systems, and III.C.2.c, Seasonal systems, of this preamble. 

The definition does not include intermittent systems, such as those that are open year-round 

but are not operated continuously (e.g., a church open only on Saturdays and Sundays). It also 

does not include systems that operate year-round but may shut down part of their distribution 

system for part of the year (e.g., parts of the distribution system that serve a factory that is open 

only certain times of the year). Since these systems might be subject to the same type of risks as 

seasonal systems, States may want to consider whether to establish requirements that will 

mitigate the risks associated with their operation.

b. Key issues raised. EPA received many responses regarding the definition of a seasonal 

system. Many commenters suggested addressing the issue of depressurization and dewatering in 

the definition. They suggested that the important risk factor is not the number of quarters the 

system is in operation but rather the closure and the depressurization and/or dewatering of the 

distribution system. Other commenters expressed concern about contamination associated with 
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lack of water movement and loss of disinfectant residual even in a pressurized system. Although 

the definition of seasonal systems does not directly address these issues, seasonal systems are 

required to perform start-up procedures (which may include disinfection, flushing, and coliform 

sampling) prior to serving water to the public. See section III.C.1.f of this preamble, Seasonal 

systems, for a discussion of the requirements for seasonal systems. EPA believes that it is 

important for a seasonal system to perform start-up procedures to mitigate the public health risks 

associated with stagnant water and the depressurization and/or dewatering of the distribution 

system. Hence, failure to perform start-up procedures will result in a treatment technique 

violation. See section III.F.b of this preamble, Coliform treatment technique violation, for 

additional discussion on this violation.

Since it is possible and perhaps likely that some systems may keep the distribution system 

pressurized while out of season, EPA has included an additional provision in the RTCR whereby

a State can exempt any seasonal system from some or all of the requirements for seasonal 

systems if the entire distribution system remains pressurized during the entire period that the 

system is not operating (see §§ 141.854(i)(3), 141.856(a)(4)(ii), and 141.857(a)(4)(ii) of the 

RTCR). In providing such exemption, the State should conclude that public health protection is 

maintained. However, a seasonal system monitoring less frequently than monthly must still 

monitor during the vulnerable period designated by the State. See section III.C.1.f of this 

preamble, Seasonal systems, of this preamble for additional discussion.

Some commenters suggested that seasonal systems be defined by the number of days, 

months, or quarters they are not in operation, e.g., 30, 60, or 90 consecutive days, three or more 

consecutive months, one full calendar quarter, etc. While such a change could address some of 
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EPA’s concerns, it does not address the potential for contamination associated with lack of 

operation and loss of pressure.

B. Rule Construct: MCLG and MCL for E. coli and Coliform Treatment Technique

1. MCLG and MCL

a. Requirements. Under the final RTCR, EPA is eliminating the MCLG for total coliforms 

(including fecal coliforms) and the MCL for total coliforms. EPA is also establishing an MCLG 

of zero and an MCL for E. coli. The MCL for E. coli is based on the monitoring results for total 

coliforms and E. coli. A system is in compliance with the E. coli MCL unless any of the 

following conditions occur:

• A system has an E. coli-positive repeat sample following a total coliform-positive routine 

sample; or

• A routine sample is E. coli-positive and one of its associated repeat samples is total coliformpositive; or

• A system fails to test for E. coli when any repeat sample tests positive for total coliforms; or

• A system fails to take all required repeat samples following a routine sample that is positive 

for E. coli.

Although not explicitly stated, as a logical consequence of the second condition, a system 

also violates the MCL when an E. coli-positive routine sample is followed by an E. coli-positive 

repeat sample because E. coli bacteria are a subset of total coliforms.

EPA is establishing an MCLG of zero for E. coli and removing the current MCLG of zero for 

total coliforms (including fecal coliforms) because E. coli is a more specific indicator of fecal 

contamination and potential harmful pathogens in drinking water than are total coliforms 

(including fecal coliforms). These requirements were part of the July 2010 proposed rule
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(USEPA 2010a, 75 FR 40926, July 14, 2010) and are unchanged in the final RTCR. See section 

III.A.2 of the preamble to the proposed RTCR, MCLG and MCL for E. coli, and coliform 

treatment technique, for further discussion on the MCLG, MCL, and treatment technique 

requirements. 

b. Key issues raised. The majority of the commenters supported EPA’s proposal to remove 

the MCLG and MCL for total coliforms (including fecal coliforms) and to establish an MCLG 

and MCL for E. coli. 

However, there were some who commented that removing the MCLG and MCL for total 

coliforms will result in backsliding in public health protection. These commenters stated that the 

elimination of the non-acute MCL violation removes a strong incentive for water systems to 

perform proactive maintenance and operations activities to maintain distribution system water 

quality and avoid MCL violations and subsequent public notice to customers. EPA disagrees. 

EPA and the advisory committee decided that removing the MCLG and MCL for total coliforms 

is appropriate. SDWA section 1412(b)(3)(A)(i) directs EPA to use “the best available, peerreviewed science and supporting studies conducted in accordance with sound and objective 

science practices” in conducting the risk assessment when promulgating an NPDWR. In 1989, 

EPA set an MCLG of zero for total coliforms. Since the promulgation of the 1989 TCR, a better 

understanding of the nature of total coliforms, especially fecal coliforms, has become available. 

Many of the organisms detected by total coliform and fecal coliform methods are not of fecal 

origin and do not have any direct public health implications (Edberg et al. 2000). Total 

coliforms may, however, indicate the presence of a pathway by which fecal contamination can 

occur; thus, total coliforms are instead used as part of a treatment technique requirement, which 

is discussed in more detail in the next section and in section III.E of this preamble, Coliform 
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Treatment Technique. Inclusion of the MCLG and MCL for total coliforms is not supported by 

the available science and would be contrary to SDWA section 1412(b)(3)(A)(i). 

Commenters agreed with EPA’s proposal to eliminate the provisions on fecal coliforms. 

Therefore, fecal coliforms will no longer be used in the RTCR and all analytical methods used to 

detect for fecal coliforms are also removed from the rule. For a discussion on analytical 

methods, see section III.I of this preamble, Analytical Methods.

2. Coliform treatment technique

a. Requirements. EPA is establishing a treatment technique that will require a PWS to 

conduct an assessment of its system and, when necessary, perform corrective actions in response 

to trigger conditions that indicate a possible pathway of contamination into the system. The 

treatment technique requirements are the same as those in the proposed RTCR. A PWS that 

exceeds a specified frequency of total coliform occurrence must conduct a Level 1 or Level 2 

assessment to determine if any sanitary defect exists and, if found, to correct the sanitary defect. 

As discussed earlier, the MCLG and MCL for total coliforms are removed. The conditions that 

defined a non-acute MCL violation under the 1989 TCR are now used to trigger a system to 

conduct an assessment of the system. A discussion of the treatment technique requirements, i.e., 

the triggers, the levels of assessment, the completion of the assessment form, etc., can be found 

in section III.E of this preamble, Coliform Treatment Technique.

b. Key issues raised. The majority of the commenters supported the change from a total 

coliform non-acute MCL to a treatment technique requirement. However, some commenters 

disagreed with the change. They stated that the treatment technique construct will not work for 

small NCWSs since they typically do not treat their water, have no certified operator, and have 

limited or no distribution system. They noted that since systems with limited or no distribution 
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system do not have the extensive network of piping and service connections and other elements 

that comprise a typical distribution system, the treatment technique construct, which the 

commenters considered as focusing on the distribution system, will not work. These 

commenters suggested that for systems with limited or no distribution system, the focus should 

be on the source, and therefore, the requirements of the GWR should be sufficient. They 

suggested that the total coliform MCL should be retained for these systems because the treatment 

technique requirements will be too complicated for these systems to comply with, resulting in 

more non-compliance, more burden on the State, and likely less public health protection. 

EPA disagrees that the treatment technique construct will not work for small NCWSs. The 

requirement to assess the system after a trigger consists of looking at all of the elements that 

might have affected the quality of the distributed water, including not only the distribution 

system but also the source and the treatment process. Although some small systems have limited 

or no distribution system, they can still have parts of their system (e.g., building plumbing, or 

buried piping of at a campground) that are vulnerable to contamination, such as that introduced 

by a cross-connection or infiltration. In addition, relying only on the corrective action provisions 

of the GWR will leave out those systems not covered by the GWR, or in cases of positive results, 

systems where corrective action under the GWR is not immediately required by the State. For 

example, total coliform-positive repeat samples do not trigger any action under the GWR, even if 

those samples are also triggered source water samples. Also, a State may require additional 

source samples instead of a corrective action after the first fecal indicator positive sample (see 40 

CFR 141.402(a)(3)). In addition, some small NCWSs with limited or no distribution system use 

surface water. Finally, the GWR provisions are focused on the source water. Since 

contamination is intermittent and can be from a location other than the source water, the 
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assessment and corrective action provisions in the RTCR will help address existing other types 

of defects and deficiencies.

EPA understands that there will be implementation challenges during the first few years of 

the rule implementation, especially for small PWSs. However, as systems with limited or no

distribution system are simple systems, the assessments should also be relatively simple. There 

is nothing in the RTCR that prohibits the States from conducting assessments that integrate the 

requirements of the GWR and RTCR where appropriate (see section III.E of this preamble, 

Coliform Treatment Technique, for a discussion of the coliform treatment technique). EPA 

encourages States to make any necessary modifications to their regulations to make the most 

efficient use of limited State resources and to better integrate these rules for systems with littleto-no distribution system, provided that the revisions satisfy the primacy requirements for both 

the GWR and the RTCR. Also, EPA plans to develop guidance manuals specifically for small 

systems to help them comply with the RTCR. EPA is also working to update the Safe Drinking 

Water Information System (SDWIS) to include the requirements of the RTCR and have SDWIS 

ready in advance of the compliance date for the rule.

As discussed earlier, EPA believes that the treatment technique requirements are more 

protective of public health because they require a system to take preventive actions to address 

problems. This is a change from just issuing a PN and conducting additional monitoring under 

the 1989 TCR to proactively doing an assessment to determine the cause of the possible 

contamination under the RTCR and performing corrective action where needed.

C. Monitoring

1. Requirements

Comment [EPA25]: Added “other” 

to match wording on page 27.
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a. Requirements that apply to all PWSs. As with the 1989 TCR, the RTCR requires all 

PWSs to collect and test samples for total coliforms and E. coli according to a sample siting plan 

and schedule specific to the system. PWSs must collect the samples at regular intervals 

throughout the month, except systems that use only ground water and serve 4,900 or fewer 

people may collect all required samples on a single day if they are taken from different sites.

Under the RTCR, all PWSs are still required to take repeat samples within 24 hours of 

learning of any routine monitoring sample that is total coliform-positive. PWSs must comply 

with the repeat monitoring requirements and E. coli analytical requirement, discussed in detail in 

section III.D of this preamble, Repeat Samples. All samples taken for RTCR compliance 

(routine and repeat) may occur at a customer’s premises, dedicated sampling station, or other 

designated compliance sampling location.

EPA notes that a system must still take the required minimum number of samples even if it 

has had an E. coli MCL violation or has exceeded the coliform treatment triggers before the end 

of the monitoring compliance period. For example, if a system has an E. coli MCL violation 

after taking 10 of the 40 required routine monthly samples, the system must continue routine 

total coliform monitoring, analyze any total coliform-positive samples for E. coli, and take one 

round of repeat samples following any total coliform-positive routine sample. 

Under the RTCR, systems’ sample siting plans must include routine and repeat sample sites 

and any sampling points necessary to meet the Ground Water Rule (GWR) requirements. As 

with the 1989 TCR, the sample siting plan is subject to State review and revision.

The repeat sample sites may be alternative monitoring locations that the PWS is proposing to 

use instead of the repeat sample locations that are within five connections upstream and

downstream of the original sampling location that tested total coliform-positive. The PWS must 

Comment [JL26]: Where did this 

cutoff come from?

Comment [EPA27]: 141.21(a)(4) of 

1989 TCR; systems serving 4,900 or 

less take 5 or fewer samples per 

month
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demonstrate to the State’s satisfaction that the alternative monitoring locations are representative 

of a pathway for contamination into the distribution system (for example, near a storage tank), 

and that the sample siting plan remains representative of the water quality in the distribution

system. Systems may elect to specify either alternative fixed locations or criteria for selecting 

their repeat sampling locations on a situational basis in a standard operating procedure (SOP), 

which is part of the sample siting plan. The State may determine that monitoring at the entry 

point to the distribution system (EPDS) (especially for undisinfected ground water systems) is 

effective to differentiate between potential source water and distribution problems. The use of 

alternative monitoring locations or an SOP does not require prior State approval but systems are 

required to submit to their primacy agencies their proposed alternative locations. States can 

modify and revise these locations or the SOP as needed. Additional discussion about the 

alternative monitoring locations can be found in section III.D of this preamble, Repeat Samples.

Monitoring locations that serve both as a repeat sampling location and a triggered source 

water monitoring location for the GWR (i.e., locations for dual purpose sampling) must also be 

included in the sample siting plan. These locations need to be approved by the State before the 

PWS can use them. For more discussion on the dual purpose sampling, see section III.D of this 

preamble, Repeat Samples.

Under the RTCR, PWSs may take more than the minimum required number of routine 

samples and must include the results in calculating whether the total coliform treatment 

technique trigger for conducting an assessment has been exceeded, but only if the samples are 

taken in accordance with the sample siting plan and are representative of water throughout the 

distribution system (see section III.E of this preamble, Coliform Treatment Technique, for a 

discussion on the coliform treatment technique requirements).
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Under the RTCR, EPA is not making substantive changes to the requirements of the TCR for 

(1) special purpose samples, and (2) invalidation of total coliform samples.

New systems that begin operation on or after the compliance date of the RTCR must comply 

with the routine monitoring frequency established by the RTCR for their system size and type 

beginning in their first month of operation.

The following are the monitoring requirements for different categories of systems.

b. Ground water NCWSs serving ≤ 1,000 people. i. Routine monitoring. The RTCR 

requires ground water NCWS serving 1,000 or fewer people to routinely monitor each quarter 

for total coliforms and E. coli except that systems can transition into RTCR at their 1989 TCR 

monitoring frequency as discussed in further detail in the next section, and there are provisions 

under which the monitoring frequency may be reduced or increased. . Seasonal systems under 

this category must routinely monitor every month that they are in operation (see section III.C.1.f 

of this preamble, Seasonal systems, for additional discussion on seasonal system requirements).

ii. Transition to the RTCR. The RTCR requires all ground water NCWSs serving 1,000 or 

fewer people, including seasonal systems, to continue with their 1989 TCR monitoring schedules 

as of the compliance date of the RTCR, unless or until any of the conditions for increased 

monitoring discussed later in this section are triggered on or after the compliance date, or unless 

otherwise directed by the State as a result of the special monitoring evaluation conducted under a 

sanitary survey or at any other time the State believes that the sampling the system is conducting 

may not be adequate. In addition, systems on annual monitoring, including seasonal systems, 

must have an initial annual site visit by the State within one year of the compliance date and an 

annual site visit each calendar year thereafter to remain on annual monitoring. Systems may 

substitute a voluntary Level 2 assessment by a party approved by the State for the annual site 

Comment [JL28]: I assume only 

required if TC is positive.

Comment [EPA29]: Yes

Comment [EPA30]: Added this text 

in lieu of moving suggested in 

comment below. Moving the 

transition section to the end as 

suggested would seem to also cause 

confusion. This addition seemed like a 

good solution.

Comment [EPA31]: Added after 

phone conversation with OMB 7/18

Comment [JL32]: Would be more 

logical to discuss all RTCR 

monitoring provisions first (including 

reduced) before the transition 

provisions. Otherwise it is confusing 

why you would allow systems to 

continue on annual monitoring.
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visit in any given year. The periodic sanitary survey may be used to meet the requirement for an 

annual site visit for the year in which the sanitary survey was completed.

After the compliance date of the final RTCR, during each sanitary survey the State must 

perform a special monitoring evaluation to review the status of the water system, including the 

distribution system, to determine whether the system is on an appropriate RTCR monitoring 

schedule and modify the monitoring schedule as necessary. States must evaluate system factors 

such as the pertinent water quality and compliance history, the establishment and maintenance of 

contamination barriers, and other appropriate protections, and validate the appropriateness of the 

water system’s existing RTCR monitoring schedule and modify as necessary. For seasonal 

systems on quarterly or annual monitoring, this evaluation must also include review of the 

approved sample siting plan, which designates the time period(s) for monitoring based on sitespecific considerations (such as during periods of highest demand or highest vulnerability to 

contamination). The system must collect compliance samples during these designated time 

periods.

iii. Reduced monitoring. The State has the discretion to reduce the monitoring frequency for 

well-operated ground water NCWSs from the quarterly routine monitoring to no less than annual 

monitoring, if the water system can demonstrate that it meets the criteria for reduced monitoring 

provided in this section. 

To be eligible to qualify for and remain on annual monitoring after the compliance date, a 

ground water NCWS serving 1,000 or fewer people must meet all of the following criteria:

• The system must have a clean compliance history (no MCL violations or monitoring 

violations under the 1989 TCR and/or RTCR, no Level 1 or Level 2 trigger exceedances or 

treatment technique violations under the RTCR) for a minimum of 12 months. (For a more 
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detailed discussion on Level 1 and Level 2 triggers, see section III.E of this preamble, 

Coliform Treatment Technique); 

• The most recent sanitary survey shows the system is free of sanitary defects, has a protected 

water source and meets approved construction standards; and

• An initial site visit by the State within the last 12 months to qualify for reduced annual 

monitoring, and recurring annual site visits to stay on reduced annual monitoring; and 

correction of all identified sanitary defects. A voluntary Level 2 assessment by a party 

approved by the State may be substituted for the State annual site visit in any given year.

iv. Increased monitoring. Ground water NCWS serving 1,000 or fewer people on quarterly 

or annual monitoring must begin monthly monitoring the month after any of the following events 

occurs:

• The system triggers a Level 2 assessment or two Level 1 assessments in a rolling 12 month 

period;

• The system has an E. coli MCL violation;

• The system has a coliform treatment technique violation (for example, if the system fails to 

conduct a Level 1 assessment or correct for sanitary defects if required to do so); or

• The system on quarterly monitoring has two RTCR monitoring violations; or 

• The system has one RTCR monitoring violation and triggers a Level 1 assessment in a 

rolling 12-month period. 

EPA added the last condition by which a ground water NCWS serving ≤ 1,000 people can be 

triggered into increased monitoring to improve the internal consistency of these triggers, given 

that these NCWSs monitor less frequently in general, and given the added flexibility for States 

to elect not to count monitoring violations at TNCWS toward triggers to increased monitoring as 
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described in the next paragraph. Since either two Level 1 assessments or two RTCR monitoring 

violations in a rolling 12-month period triggers increased monitoring, EPA believes it is 

appropriate for one of each of these events to also trigger increased monitoring for these 

NCWSs. See section III.E.1 of this preamble, Coliform treatment technique triggers, for a 

discussion of coliform treatment technique triggers. 

EPA also added flexibility to allow States to elect to not count For TNCWSs, the State may 

elect not to count monitoring violations in determining whether the trigger for increased 

monitoring has been exceeded, (i.e., for having two monitoring violations or one monitoring 

violation and one Level 1 assessment trigger in a rolling 12-month period for systems on 

quarterly monitoring) but only if the missed sample is collected no later than the end of the next 

monitoring period. The system must collect the make-up sample in a different week than the 

routine sample for the nextat monitoring period and should collect the sample as soon as 

possible during the next monitoring period. This provision applies only for routine samples. 

The TNCWS would still incur a monitoring violation and must follow the other requirements 

associated with such violation (e.g., public notification and reporting). This provision is added 

in response to comments received by EPA. See section III.C.2.b of this preamble, Ground water 

NCWSs serving ≤ 1,000 people, for additional discussion of this provision.

EPA also added an additional condition by which a system can be triggered into increased 

monitoring. This tightens the provisions regarding increased monitoring so that a system that 

has a monitoring violation (and does not take without a state-authorized makeup sample) and 

triggers a Level 1 assessment also triggers monthly monitoring, in addition to the triggers for 

increased monitoring of having two monitoring violations (with no state-authorized makeup 

Comment [EPA33]: We moved and 

edited text to clarify requirements, in 

response to OMB language edits 

regarding makeup samples here and in 

the paragraph below.
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samples) or two Level 1 triggers assessments. See section III.E.1 of this preamble, Coliform 

treatment technique triggers, for a discussion of coliform treatment technique triggers.

Ground water NCWS serving 1,000 or fewer people on annual monitoring must begin 

quarterly monitoring the month after the following event occurs: 

• The system on annual monitoring has one RTCR monitoring violation. 

This is a change from the proposed rule requirement where the event would have triggered the 

system to go to monthly monitoring instead of quarterly monitoring. This change is further 

discussed in section III.C.2.b of this preamble, Ground water NCWSs serving ≤ 1,000 people.

The system must continue monthly or quarterly monitoring until the requirements in this 

section for returning to quarterly or annual monitoring are met.

v. Requirements for returning to quarterly monitoring. To be eligible to return from 

increased monthly monitoring to quarterly monitoring, ground water NCWSs serving 1,000 or 

fewer people must meet all of the following criteria:

• Within the last 12 months, the system must have a completed sanitary survey or a site visit by 

the State or a voluntary Level 2 assessment by a party approved by the State. The system is 

free of sanitary defects, and has a protected water source; and

• The system has a clean RTCR compliance history (no E. coli MCL violations, Level 1 or 2 

triggers, coliform treatment technique violations or monitoring violations) for a minimum of 

12 months.

For TNCWSs, the State may elect not to count monitoring violations towards the requirement 

of a clean compliance history (as presented in the last bullet) if the missed sample is collected no 

later than the end of the next monitoring period. This applies only for routine samples. The 

TNCWS would still incur a monitoring violation and must follow the other requirements 
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associated with such violation (e.g., public notification and reporting). See section III.C.2.b of 

this preamble, Ground water NCWSs serving ≤ 1,000 people, for additional discussion about this 

provision.

vi. Requirements for returning to reduced annual monitoring. To be eligible to return from 

increased monthly monitoring to reduced annual monitoring, the system must meet the criteria to 

return to routine quarterly monitoring plus the following criteria:

• An annual site visit (recurring) by the State and correction of all identified sanitary defects. 

An annual voluntary Level 2 assessment may be substituted for the State annual site visit in 

any given year; and

• The system must have in place or adopt one or more additional enhancements to the water 

system barriers to contamination as approved by the State. These measures could include but 

are not limited to the following:

− Cross connection control, as approved by the State.

− An operator certified by an appropriate State certification program, which may include 

regular visits by a circuit rider certified by an appropriate State certification program.

− Continuous disinfection entering the distribution system and a residual in the distribution 

system in accordance with criteria specified by the State.

− Maintenance of at least a 4-log inactivation or removal of viruses each day of the month 

based on daily monitoring as specified in the GWR (with allowance for a 4-hour 

exception).

− Other equivalent enhancements to water system barriers to contamination as approved by 

the State.
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vii. Additional routine monitoring. All systems collecting samples on a quarterly or annual 

frequency must conduct additional routine monitoring following a single total coliform-positive 

sample (with or without a Level 1 trigger event). The additional routine monitoring consists of 

three samples in the month following the total coliform-positive sample at routine monitoring 

locations identified in the sample siting plan. This is a change from the 1989 TCR additional 

routine monitoring requirement of taking a total of five samples the month following a total 

coliform-positive sample for systems that take four or fewer samples per month. Consistent with 

the 1989 TCR, the State may waive the additional routine monitoring requirement if:

• The State, or an agent approved by the State, performs a site visit before the end of the next 

month the system provides water to the public. Although a sanitary survey need not be 

performed, the site visit must be sufficiently detailed to allow the State to determine whether 

additional monitoring and/or any corrective action is needed. The State cannot approve an 

employee of the system to perform this site visit, even if the employee is an agent approved 

by the State to perform sanitary surveys or RTCR assessments.

• The State has determined why the sample was total coliform-positive and establishes that the 

system has corrected the problem or will correct the problem before the end of the next 

month the system serves water to the public. In this case, the State must document this 

decision to waive the following month's additional monitoring requirement in writing, have it 

approved and signed by the supervisor of the State official who recommends such a decision, 

and make this document available to the EPA and public. The written documentation must 

describe the specific cause of the total coliform-positive sample and what action the system 

has taken and/or will take to correct this problem. 
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• The State may not waive the requirement to collect three additional routine samples the next 

month in which the system provides water to the public solely on the grounds that all repeat 

samples are total coliform-negative. If the State determines that the system has corrected the 

contamination problem before the system takes the set of repeat samples required in §

141.858, and all repeat samples were total coliform-negative, the State may waive the 

requirement for additional routine monitoring the next month.

All additional routine samples are included in determining compliance with the MCL and 

coliform treatment technique requirements.

c. Ground water CWSs serving ≤ 1,000 people. i. Routine monitoring. The RTCR requires 

ground water CWSs serving 1,000 or fewer people to routinely monitor at least once each month 

for total coliforms and E. coli except that systems can transition into RTCR at their 1989 TCR 

monitoring frequency as discussed in further detail in the next section, and there are provisions 

under which the sampling frequency may be reduced by the State. unless the sampling 

frequency has been reduced by the State under the RTCR.

The State may reduce the monitoring frequency for ground water CWS from the monthly 

routine monitoring to quarterly reduced monitoring if the water system can demonstrate that it 

meets the criteria for reduced monitoring provided later in this section.

ii. Transition to the RTCR. All ground water CWSs serving 1,000 or fewer people continue 

with their 1989 TCR monitoring schedules unless or until any of the increased monitoring 

requirements in this section occur or as directed by the State.

After the compliance date of the final RTCR, the State must determine whether the system is 

on an appropriate monitoring schedule by performing a special monitoring evaluation during 

each sanitary survey to review the status of the PWS, including the distribution system. The first 

Comment [EPA35]: Added after 

phone call with OMB 7/18

Comment [EPA34]: Added this text

in lieu of moving suggested in Jim’s 

comment below. Moving the 

transition section to the end as 

suggested would seem to also cause 

confusion. This addition seemed like a 

good solution.

Comment [JL36]: Again, move this 

after full description of RTCR reqs.

Comment [JL37]: Any time limit for 

first evaluation.

Comment [EPA38]: At the next 

scheduled san survey, so will occur 

within 3 years (CWS) or 5 years 

(NCWS). This reduces state burden.
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such evaluation must be conducted during the first scheduled sanitary survey after the effective 

date of the rule; a system may remain on its 1989 TCR monitoring schedule until this time unless 

it is triggered into more frequent monitoring. After its first evaluation, the State may allow the 

system to remain on its 1989 TCR monitoring schedule as long as the system meets the 

conditions for doing so. The State must evaluate system factors such as the pertinent water 

quality and compliance history, the establishment and maintenance of barriers to contamination, 

and other appropriate protections to validate the water system’s existing monitoring schedule or 

require more frequent monitoring.

iii. Reduced monitoring. The State has the flexibility to reduce the monitoring frequency for 

well-operated ground water CWS from the monthly routine monitoring to no less than quarterly 

monitoring if the water system can demonstrate that it meets the criteria for reduced monitoring 

provided in this section.

To be eligible for to change from monthly to quarterly reduced monitoring after the 

compliance date, ground water CWSs serving 1,000 or fewer people on monthly monitoring after 

the compliance date must be in compliance with any State-certified operator provisions and meet 

each of the following criteria:

• The system must have a clean compliance history (no MCL violations or monitoring 

violations under the TCR and/or RTCR, no Level 1 or Level 2 trigger exceedances or 

treatment technique violations under the RTCR) for a minimum of 12 months; 

• The most recent sanitary survey shows the system is free of sanitary defects (or has an 

approved plan and schedule to correct them and is in compliance with the plan and the 

schedule), has a protected water source, and meets approved construction standards; and

• The system must meet at least one of the following criteria: 

Comment [EPA39]: OMB and EPA 

clarifying edits.

Comment [EPA40]: Added as 

discussed with OMB on 7/26.

Comment [EPA41]: OMB suggested 

edits 7/25, ok.

Comment [EPA42]: Added after 

conversation with OMB 7/18

Comment [JL43]: What does this 

mean?

Comment [EPA44]: This was a 

condition of the AIP, page 12. CWS 

must employ an operator certified 

through a state certification program 

as qualified to operate the type of 

treatment plant/water system at which 

the operator is employed (surface, 

ground, community, distribution 

system). State certification 

requirements vary, and that is why 

there is a special primacy provision 

that states must describe their 

program. Some states allow a 

certified professional engineer on 

retainer
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− An annual site visit by the State or an annual voluntary Level 2 assessment by a party 

approved by the State or meeting criteria established by the State and correction of all 

identified sanitary defects (or an approved plan and schedule to correct them and is in 

compliance with the plan and schedule).

− A cross connection control program, as approved by the State.

− Continuous disinfection entering the distribution system and a residual in the distribution 

system in accordance with criteria specified by the State.

− Demonstration of maintenance of at least a 4-log inactivation or removal of viruses each 

day of the month based on daily monitoring as specified in the GWR (with allowance for 

a 4-hour exception) (USEPA 2006c, 71 FR 65574, November 8, 2006).

− Other equivalent enhancements to water system barriers to contamination as approved by 

the State.

iv. Requirements for returning to monthly monitoring. When a system on quarterly 

monitoring experiences any of the following events the system must begin monthly monitoring 

the month after the event occurs:

• System triggers a Level 2 assessment or two Level 1 assessments in a rolling 12-month 

period.

• System has an E. coli MCL violation.

• System has a coliform treatment technique violation (e.g., fails to conduct a Level 1 or Level 

2 assessment or to correct for a sanitary defect if required to do so).

• System has two routine RTCR monitoring violations in a rolling 12-month period. 

Comment [JL45]: What about one 

Level 1 assessment and one 

monitoring violation, as with 

NCWSs?

Comment [EPA46]: It only applies to 

NCWSs; it was added for NCWSs 

because in the final rule states can 

elect to not count monitoring 

violations at TNCWSs toward triggers 

for increased monitoring, to address 

burden concerns for states that have 

large numbers of TNCWSs
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The system must continue monthly monitoring until all the reduced monitoring requirements 

discussed previously in this section are met. A system that loses its certified operator must also 

return to monthly monitoring the month following the loss.

v. Additional routine monitoring. Ground water CWSs serving ≤ 1,000 people collecting 

samples on a quarterly frequency must conduct additional routine monitoring following a single 

total coliform-positive sample (with or without a Level 1 trigger event), similar to the additional 

monitoring requirements for ground water NCWS serving ≤ 1,000 people. See section 

III.C.1.b.vii of this preamble, Additional routine monitoring, for a discussion of the additional 

routine monitoring requirements.

d. Subpart H systems serving ≤ 1,000 people. The monitoring requirements for subpart H 

systems of this part (PWSs supplied by a surface water source or by a ground water source under 

the direct influence of surface water (GWUDI) source) serving 1,000 or fewer people remain the 

same as under the 1989 TCR (see § 141.856). These systems are not eligible for reduced 

monitoring. In addition, the rule requires all seasonal systems, on and after the compliance date 

of the final RTCR, to demonstrate completion of a State-approved start-up procedure (see section 

III.C.1.f of this preamble, Seasonal systems, for additional discussion on seasonal system 

requirements).

e. PWSs serving > 1,000 people. The monitoring requirements for PWSs serving more than 

1,000 people remain the same as under the 1989 TCR (see § 141.857), with the exception of the 

applicable revisions to the repeat sampling locations provided in § 141.858 and to the additional 

routine monitoring provisions. Systems on monthly monitoring are not required to take 

additional routine samples the month following a total coliform-positive sample, as 

recommended by the advisory committee (see section III.A.3.b.ii(g) of the preamble to the 
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proposed RTCR, Additional routine monitoring, for an explanation of this change from the 1989 

TCR). Consistent with the 1989 TCR, these systems serving > 1,000 people are not eligible for 

reduced monitoring. In addition, the rule requires all seasonal systems, on and after the 

compliance date of the final RTCR, to demonstrate completion of a State-approved start-up 

procedure (see section III.C.1.f of this preamble, Seasonal systems, for additional discussion on 

seasonal system requirements).

f. Seasonal systems. Since seasonal systems are a subset of NCWSs, they are subject to the 

requirements of the particular NCWS size category they fall under (e.g., seasonal systems using 

ground water and serving ≤ 1,000 people are subject to the requirements of ground water NCWS 

serving ≤ 1,000 people, or seasonal systems using surface water and serving ≤ 1,000 people are 

subject to the requirements of subpart H systems serving ≤ 1,000 people, and so on), unless 

otherwise noted. The RTCR is promulgating requirements specific to seasonal systems to 

mitigate the risk associated with the unique characteristics of this type of systems (see section 

III.A.4 of this preamble, Seasonal systems, for additional discussion about seasonal systems). 

One of the provisions is the requirement that all seasonal systems must demonstrate completion 

of a State-approved start-up procedure prior to serving water to the public on and after the 

compliance date of the final RTCR each time they start up the system. The start-up procedure 

may include a requirement for a start-up sample prior to serving water to the public.

Under the RTCR, all seasonal systems are required to take at least one routine sample per 

month for total coliforms and E. coli during the months that they are in operation, unless the 

sampling frequency has been reduced by the State under the RTCR. For sSeasonal systems 

serving > >1,000 people have the same, their monitoring frequency is the same as other PWSs 

serving > > 1,000 people (see § 141.857 of the RTCR) and it cannot be reduced. However, 

Comment [JL47]: Clarify what 

systems you are referring to here: all 

PWSs serving > 1000 people, or just 

those with a TC positive sample.

Comment [EPA48]: Edited to 

address Jim’s comment above

Comment [EPA49]: Added for 

clarification 

8/6/12
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seasonal systems serving ≤≤ 1,000 people that are not on monthly monitoring by the compliance 

date of the RTCR may continue with their existing 1989 TCR monitoring frequency afterwards, 

unless or until any of the conditions for increased monitoring discussed previously in section 

III.C.1.b.iv of this preamble, Increased monitoring, are triggered on or after the compliance date, 

or as directed by the State. To continue on their existing 1989 TCR monitoring frequency, 

seasonal systems on less than monthly monitoring at the compliance date of the RTCR must 

have an approved sample siting plan that designates the time period for monitoring based on sitespecific considerations (e.g., during periods of highest demand or highest vulnerability to 

contamination). The system must collect compliance samples during this time period. Seasonal 

systems on annual monitoring frequency are required to have a recurring annual site visit by the 

State (or an annual voluntary Level 2 assessment by a party approved by the State) to remain on 

annual monitoring. For seasonal systems serving >1,000 people, their monitoring frequency is 

the same as other PWSs serving > 1,000 people (see § 141.857 of the RTCR) and cannot be 

reduced.

Only seasonal systems using ground water and serving ≤ 1,000 people are eligible for

reduced monitoring. To be newly eligible for reduced monitoring after the compliance date, they 

must meet the following criteria:

• The system must have an approved sample siting plan that designates the time period for 

monitoring based on site-specific considerations (e.g., during periods of highest demand or 

highest vulnerability to contamination). The system must collect compliance samples during 

this time period; and

Comment [JL50]: I assume these 

would only be systems serving <= 

1000 people.

Comment [EPA51]: Correct, added 

and moved text to clarify for which 

seasonal systems reduced and 

increased monitoring applies.

Comment [EPA52]: To address JL 

comment below

Comment [EPA53]: Added after 

phone call with OMB 7/18

Comment [JL54]: I assume this has 

to be in place for grandfathered 

reduced monitoring as well. If so, 

clarify above.

Comment [EPA55]: See text added 

above
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• To be eligible for reduced quarterly monitoring, the system must also meet all the reduced 

monitoring criteria discussed in section III.C.1.b.v of this preamble, Requirements for 

returning to quarterly monitoring, and provided in § 141.854(g) of the RTCR. 

• To be eligible for reduced annual monitoring, the system must also meet all the reduced 

monitoring criteria discussed in section III.C.1.b.vi of this preamble, Requirements for 

returning to reduced annual monitoring, and provided in § 141.854(h) of the RTCR.

The State may exempt any seasonal system from some or all of the requirements for seasonal 

systems (e.g., performing start-up procedures) if the entire distribution system remains 

pressurized during the entire period that the system is not operating. However, systems that 

monitor less frequently than monthly must still monitor during the vulnerable time period 

designated in their approved sample siting planby the State.

g. Consecutive systems. EPA did not identify any issues regarding consecutive systems in 

the RTCR. Consecutive systems must monitor for total coliforms at a frequency based on the 

population served by the consecutive system and the source water type of the wholesale system. 

In instances where it is justified to treat two or more distribution systems as a single system for 

monitoring purposes, 40 CFR 141.29 allows the State to modify the monitoring requirements for 

the combined distribution system. Any modifications to the monitoring requirements must be 

approved by EPA. The State may not, however, modify the compliance requirements. The 

RTCR is not modifying the provisions of 40 CFR 141.29. When conducting assessment and 

corrective action under the RTCR, wholesalers and consecutive systems should cooperate as 

directed by the State and conduct assessment and corrective action based on the location of the 

positive sample results, the potential pathways of distribution system contamination, and the 

sanitary defects identified. 

Comment [JL56]: Are the 

requirements for “returning” to 

reduced monitoring the same as the 

initial requirements for reduced 

monitoring? I thought requirements 

for returning were more stringent. 

Seems like initial requirements would 

be relevant here.

Comment [EPA57]: This was in the 

AIP, page 14. Advisory committee 

was very concerned about seasonal 

systems. Note also that routine 

monitoring for seasonal systems is 

monthly, which is equivalent to 

increased monitoring for non-seasonal 

systems. Therefore these seasonal 

systems on routine (monthly) 

monitoring must meet the same 

reduced monitoring criteria as nonseasonal systems on monthly 

monitoring that may be trying to 

return to reduced

Comment [JL58]: Clarify what this 

refers to. Is this something that the 

state must designate for all seasonal 

systems.

Comment [EPA59]: Clarified using 

same text as above. See also the first 

of three bullets above. Applies only to 

seasonal on less than monthly 

monitoring

Comment [JL60]: Is this a change 

from the current TCR? Agreed to by 

advisory committee?

Comment [EPA61]: Not a change 

from the current TCR. The advisory 

committee did not address, so by their 

agreement, the provision stands 

unchanged. See AIP section 2.0, 

number 7: “Unless otherwise noted, 

the TCRDSAC recommends that the 

TCR provisions and current rule 

implementation continue unchanged.”
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2. Key issues raised

a. Sample siting plans. The majority of the comments EPA received supported the proposal 

that sample siting plans be subject to State review and revision instead of requiring State 

approval. The advisory committee recommended that States review and revise sample siting 

plans consistent with current practice and that the State develops and implements a process to 

ensure the adequacy of sample siting plans. EPA also received comments that requiring State 

approval of sample siting plans will be an additional burden to the States. Considering these 

comments and the recommendation of the advisory committee, EPA, therefore, is not changing 

the requirement regarding State review and revision of the sample siting plan in most instances. 

There are, however, instances where it may beis necessary for the State to review and approve

elements of the sample siting plan, and other instances where the need for State approval is left 

to State discretion. For example, seasonal systems on less than monthly monitoring must have 

an approved sample siting plan that designates the vulnerable time period for collecting the 

sample(s) as discussed previously in section III.C.1.f of this preamble, Seasonal systems. .; On 

the other hand, for systems that want to establish repeat sampling locations other than the withinfive-connections-upstream-and-downstream of the total coliform-positive sample, the system 

must submit the siting plan for review and the sState may modify the sampling locations as 

needed, but State approval is not required by the RTCR, as discussed in section III.D of this 

preamble, Repeat Samples. States have the flexibility to determine how best to review and 

approve these provisions.

EPA received comment that supported the use of dedicated sampling locations. Although not 

specifically authorized,addressed Tthis practice is already observed in use by some sStates and 

Comment [JL62]: It is unclear from 

this discussion whether state approval 

is required in these situations by the

RTCR or if this is up to the state. 

Please be precise about what the rule 

requires and what discretion is left to 

the state.

Comment [EPA63]: Final as edited 

by OMB and EPA to address Jim’s 

comment above.
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systems under the 1989 TCR. As discussed in the proposed RTCR, EPA is specifically allowing 

the use of dedicated sampling stations for the following reasons:

• To reduce potential contamination of the sampling taps. Utilities will have more control to 

prevent contamination of the sampling tap by preventing its use by unauthorized persons and 

allowing no routine use of the tap except for sampling.

• To facilitate access to sampling taps. Currently systems may be constrained by where they 

sample, e.g., only at public buildings or in certain individual customer’s house.

• To improve sampling representation of the distribution system. Allowing dedicated sampling 

taps in areas where systems have not been able to gain access will facilitate better sampling 

representation of the distribution system.

b. Ground water NCWSs serving ≤ 1,000 people. EPA received comments regarding the 

monitoring requirements of for small ground water NCWSs. Many of the commenters agreed 

with the requirements proposed while some commenters suggested that systems should not be 

allowed to monitor less than monthly.

The advisory committee recommended that the routine monitoring frequency for ground 

water NCWSs serving 1,000 or fewer people remain at quarterly monitoring as provided in the 

1989 TCR. EPA believes that quarterly monitoring carried out in conjunction with the 

assessment and corrective action requirements would maintain or improve public health 

protection without increasing sampling costs over the 1989 TCR requirements. The advisory 

committee also recognized that current sampling costs are not insignificant for small systems, 

and wanted to allow reduced monitoring for well-performing systems under the more specific 

and rigorous criteria described previously in sections III.C.1.b.iii, Reduced monitoring, and 

III.C.1.c.iii, Reduced monitoring, of this preamble. To continue to provide adequate health 
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protection, systems on reduced monitoring must adhere to criteria that ensure that barriers are in 

place and are effective. Furthermore, systems with problems that may indicate poor system 

integrity, maintenance, or operations, or systems that fail to monitor, are triggered into more 

frequent monitoring. This approach leverages the limited resources of well-operated small 

ground water NCWSs and of States, so that well-performing operated systems can minimize 

their costs and States can focus their resources on systems needing the greatest attention, such as 

systems with problems or vulnerabilities.

EPA requested comment in the proposed rule on whether to require NTNCWSs to comply 

with the CWS requirements (as they are in other rules such as disinfection byproduct (DBP)

rules) since NTNCWSs serve the same people over time and include populations that may be at 

greater risk (e.g., schools, hospitals, daycare centers). 

EPA received comments both in agreement and disagreement of the concept with this 

approach. Those who disagreed stated that such requirement would result in disproportionate 

impact on NTNCWS, since these systems are small systems with limited resources. One 

commenter said that the 1989 TCR has been in effect for decades now and there have been no 

adverse health effect impacts by not having NTNCWSs comply with CWS requirements.

Considering the comments EPA received, the Agency is not requiring NTNCWSs to comply 

with CWS requirements under the RTCR. However, EPA recommends that States consider the 

population served at NTNCWSs, especially those that serve sensitive subpopulations such as 

schools, hospitals, and daycare centers, when they decide on an appropriate monitoring 

frequency. EPA is aware that some States are already doing so and suggests that other States 

consider the same. 
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EPA received comments that the criteria for returning to reduced monitoring are overly strict, 

including a suggestion that the requirement to have an additional barrier enhancement to return 

to annual monitoring is too burdensome and costly. Some commenters stated that systems that 

are triggered into increased monitoring will be unlikely to return to reduced monitoring. Another 

commenter suggested that a system should be able to return to reduced monitoring sooner than 

12 months.

EPA continues to believe that for a system to be able to monitor only once a year, it should 

be able to demonstrate that it has the ability to continually deliver safe water by ensuring that 

barriers are in place to protect against contamination. A system that has been triggered into 

increased monitoring has failed in some way to demonstrate that it has those barriers in place.

The requirements to return to reduced monitoring are intended to show that the system has made 

the long-term commitment and provided the necessary additional barriers to eliminate the 

vulnerability to contamination that triggered the increased monitoring in the first place. EPA 

believes that the requirements for returning to reduced monitoring are not impossible to meet but 

require an appropriate level of effort over at least 12 months to show the commitment and ability 

to delivering safe water.

EPA received comments regarding monitoring violations as a trigger for increased 

monitoring and as part of the criteria for returning to reduced monitoring. EPA heard from 

States with large numbers of NCWSs that including monitoring violations as a trigger for 

increased monitoring and as part of the criteria for reduced monitoring will make the RTCR 

difficult to implement in their States. NCWSs, especially TNCWSs, pose unique challenges to 

rule compliance as they typically do not have the resources that CWSs have and providing water 

is not their primary business. Commenters suggested that triggering a NCWS into increased 
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monitoring because of just one or two missed samples is not appropriate and will burden the 

State with compliance and enforcement tracking. They thouight indicated that this will shift 

limited State resources away from oversight activities for CWSs that serve large populations to 

compliance and enforcement activities for NCWSs that serve small populations, resulting in 

decreases in public health protection. The commenters also concluded that once a system is 

triggered into increased monitoring, it would not be able to qualify for reduced monitoring 

because it would not be able to meet the requirements for clean compliance history (e.g., no 

monitoring violations). 

EPA recognizes the burden on States that may result from implementing the increased and 

reduced monitoring provisions of the RTCR. EPA is therefore providing States the flexibility to 

not count monitoring violations towards eligibility for remaining on quarterly monitoring or for 

returning to quarterly monitoring as long as a make-up sample is collected by the end of the next 

monitoring period. This flexibility only applies to TNCWSs and only for routine samples. The 

State cannot use this flexibility to qualify a system for annual monitoring. When exercising the 

flexibility about whether to count a monitoring violation towards eligibility for reduced 

monitoring, the State may find it appropriate to also consider the system’s history of monitoring 

violations. The TNCWSs would still incur a monitoring violation and must comply with the 

other associated requirements after such violation (e.g., public notification and reporting).

In the proposed rule, a NCWS on annual monitoring with one RTCR monitoring violation is

triggered into monthly monitoring. Some commenters expressed concern that many systems on 

annual monitoring will be triggered to monthly monitoring because of just one missed sample. 

The commenters stated that this was unreasonable considering that these systems typically do not 

have the resources that CWSs have, such as a certified operator. These systems typically 
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experience frequent staff shortages or turnover that result in missed samples. Having these 

systems do monthly monitoring would require significant tracking and enforcement activities on 

the part of the State.

To address this concern, EPA has changed the consequence of having one RTCR monitoring 

violation for systems on annual monitoring. Instead of having to go to monthly monitoring, the 

system now moves to quarterly monitoring. EPA also believes that the annual site visit by the 

State, and the fact that some States conduct and/or pay for the annual monitoring, reduces the 

likelihood that systems on annual monitoring will miss samples and be triggered to increase to 

quarterly monitoring, so that PWS and State resource needs are not likely to significantly 

increase because of this requirement. EPA is not changing the consequence of exceeding the 

other triggers for increased monitoring; systems that experienced any of the other events in 

section III.C.1.b.iv of this preamble, Increased monitoring, will need to monitor monthly instead 

of quarterly. Systems can go back to annual monitoring by meeting the criteria for reduced 

monitoring.

EPA requested comment on whether daily chlorine residual measurements should be one of 

the criteria for reduced monitoring. EPA received comments that said that it should not be a 

criterion. Some commenters expressed concern that one missed measurement might be a basis 

for being bumped to increased monitoring. One commenter suggested giving the State the 

discretion to either allow or not allow it as a criterion. Section 141.854(h)(2)(iii) of the RTCR 

specifies that one of the enhancements to water system barriers to contamination is continuous 

disinfection entering the distribution system and a residual in the distribution system in 

accordance with criteria specified by the State. States are given the discretion on to decide how 
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they want to implement this criterion based on site-specific considerations. States may want to 

require daily measurement of chlorine residual to demonstrate continuous disinfection.

One commenter expressed concern that a reduction in the number of additional routine 

samples (i.e., from five to three) reduces the likelihood of detecting both total coliforms and E. 

coli. The advisory committee recommended that it is appropriate to drop from five to three 

samples the following month to reduce monitoring costs while still maintaining a substantial 

likelihood of identifying a problem if a problem persists. EPA and the advisory committee 

recognized that a reduction in the number of samples taken could also mean a reduction in the 

number of positive samples found. However, EPA and the advisory committee concluded that

the new assessment and corrective action provisions of the RTCR lead to a rule that is more 

protective of public health and to improvement in water quality despite the reductions in the 

number of samples taken. The Final RTCR EA occurrence modeling results support this 

conclusion, as they predict that more E. coli MCL violations will be prevented and total coliform 

and E. coli-positive hit rates will decrease when assessment and corrective action occur. See 

chapter 6 of the Final RTCR EA (USEPA 2012a) for more details.

c. Seasonal systems. EPA received comments that disagreed with the routine monthly 

monitoring frequency for seasonal systems. The commenters suggested that requiring a start-up 

procedure is the essential element and having seasonal systems monitor quarterly like all other 

NCWSs should be adequate. Other commenters agreed with monthly monitoring.

As discussed in section III.A.4 of this preamble, Seasonal systems, seasonal systems are 

more susceptible to contamination due to changes in the conditions of the source water during 

the period the system is in operation. Such changes include variable contaminant loading due to 

increased septic tank or septic field use, the seasonal nature of the demand, and the stress the 
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system may experience. Because of the risk factors, the advisory committee decided that more 

frequent monitoring is appropriate for these systems, with the possibility of going on reduced 

monitoring if they meet certain criteria. EPA concurs with the advisory committee assessment 

and the final rule maintains the proposed routine monthly monitoring frequency, when they are 

in operation, for seasonal systems.

One commenter said that a regular sampling schedule is more easily achieved and more 

practical than identifying vulnerable time periods as these periods can vary from year to year. 

EPA believes that a system that will monitor less frequently than monthly should take a sample 

based on site-specific considerations (e.g., during periods of high demand or highest 

vulnerability of contamination). This increases the probability of detecting a possible 

contamination; hence, measures can be taken to address the possible contamination before it 

becomes a public health threat. 

One commenter suggested that start-up procedures must include flushing, disinfection, reflushing to eliminate disinfectant residual, and taking a sample prior to serving water to the 

public. EPA is not requiring specific practices regarding the start-up procedure. States are given 

the flexibility to determine what start-up procedures are appropriate for a particular system based 

on its site-specific considerations and must describe their process for determining start-up 

procedures in their primacy application. EPA recommends that States require seasonal systems 

to take a sample as part of the required start-up procedures. Systems must allow sufficient time 

for completing start-up procedures (including receiving sample results) and notifying the State as 

required prior to serving water to the public.

D. Repeat Samples

1. Requirements

Comment [EPA64]: Added 8/6/12 

for clarification

Comment [JL65]: Is this a step 

required by the RTCR or up to the 

state? If the former, would you 

consider leaving it up to the state. If 

the state is satisfied that it’s 

procedures are adequate, not sure 

what value there is in requiring the 

system to “notify the state” prior to 

serving water to the public.

Comment [EPA66]: Required. The 

advisory committee recommended 

that “all seasonal systems, on and after 

the compliance effective date, must 

demonstrate completion of a primacy 

agency approved start up procedure.”

JL: Seems to me the AIP language 

here is somewhat ambiguous. Did 

you receive any adverse comments on 

this provision?

EPA – no adverse comments received. 

One state (WV) suggested there must 

be a deadline for submitting to the 

state. Six other comments supporting 

the need for startup procedures 

(including AL, WI, PA) 

JL withdrew comment on 7/25
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Under the RTCR, all PWSs must take at least three repeat samples for each routine sample 

that tested positive for total coliforms. This is a change from the 1989 TCR requirements where 

systems serving 1,000 or fewer people must collect at least four repeat samples while the rest of 

the systems must collect three repeat samples. 

As discussed in the preamble to the proposed RTCR, EPA believes that sampling again 

immediately after determining that a sample is positive (i.e., conducting repeat sampling) 

increases the likelihood of identifying the source and/or nature of the possible contamination. 

Analyses conducted by EPA indicated that once a total coliform-positive is found, there is a 

much greater likelihood of finding another total coliform-positive within a short period of time of 

the initial finding (see page 40939 of the Federal Register (FR) notice for the proposed RTCR 

(USEPA 2010a, 75 FR 40926, July 14, 2010) for more discussion on the analyses done by EPA 

regarding repeat samples). Repeat sampling (when it is total coliform-positive) can indicate a 

current pathway for potential external contamination into the distribution system. EPA 

recommends that States work with PWSs and laboratories to facilitate timely notification through 

the most expeditious method (e.g., phone, fax, or email) to ensure that repeat samples are taken 

in a timely manner.

The repeat monitoring requirements of the RTCR are essentially the same as the 

requirements of the 1989 TCR, except for some new provisions promulgated by the RTCR to 

provide flexibility to States and PWSs. The following requirements are not changing under the 

RTCR:

• PWSs must collect the repeat samples within 24-hours of being notified that their routine 

sample is total coliform-positive.
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• The State can extend the 24-hour limit on a case-by-case basis. EPA is providing flexibility 

to this provision as discussed later in this section.

• The State cannot waive the requirement for a system to collect repeat samples.

• In addition to taking repeat samples, PWSs must test each routine total coliform-positive 

sample for E. coli. They must also test any repeat total coliform-positive sample for E. coli. 

If E. coli is present, the system must notify the State the same day it learns of the positive 

result, or by the end of the next business day if the State office is closed and the State does 

not have either an after-hours phone line or an alternative notification procedure.

• The State has the discretion to allow the system to forgo E. coli testing in cases where the 

system assumes that the total coliform-positive sample is E. coli-positive. If the State allows 

a system to forgo E. coli testing, the system must still notify the State and comply with the E. 

coli MCL requirements specified in § 141.858.

• The system must collect at least one repeat sample from the sampling tap where the original 

total coliform-positive sample was taken. Unless different locations are specified in its 

sample siting plan (this is a new provision of the RTCR and is discussed later in this section), 

the system must also collect at least one repeat sample at a tap within five service 

connections upstream, and at least one repeat sample at a tap within five service connections 

downstream of the original sampling site. The State may waive the requirement to collect at 

least one repeat sample upstream or downstream of the original sampling site if the total 

coliform-positive sample is at the end of the distribution system, or one service connection 

away from the end of the distribution system. EPA notes that it is the location of the repeat 

sample that is waived, not the required number of repeat samples. A PWS still needs to take 
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the required repeat sample(s) elsewhere in the distribution system if it is unable to do so 

upstream or downstream of the original sampling site. 

• Systems must collect all repeat samples on the same day. The State may allow systems with 

a single service connection to collect the required set of repeat samples over a three-day 

period or to collect a larger volume repeat sample(s) in one or more sample containers of any 

size, as long as the total volume collected is at least 300 milliliters (ml).

• Systems must collect an additional set of repeat samples for each total coliform-positive 

repeat sample. As with the original set of repeat samples, the system must collect the 

additional repeat samples within 24 hours of being notified of the positive result, unless the 

State extends the time limit. The system must repeat this process until either total coliforms 

are not detected in one complete set of repeat samples or, as the RTCR is adding, the system 

determines that the coliform treatment technique trigger has been exceeded and notifies the 

State. After a trigger (see section III.E, of this preamble, Coliform Treatment Technique) is 

reached, the system is required to conduct only one round of repeat monitoring after each 

total coliform-positive or E. coli-positive routine sample. If a trigger is reached as a result of 

a repeat sample being total coliform- or E. coli-positive, no further repeat monitoring related 

to that sample is necessary.

• A subsequent routine sample, which is within five service connections of the initial routine 

sample and is collected after an initial routine sample but before the system learns the initial 

routine sample is total coliform-positive, may count as a repeat sample instead.

• A ground water system with a single well serving less 1,000 or fewer people may still use a 

repeat sample collected from a ground water source to meet both the repeat monitoring 

requirements of the RTCR and the triggered source monitoring requirements of the GWR 
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(i.e., a dual purpose sample). Modifications to this provision under the RTCR are discussed 

later in this section.

As mentioned previously, the RTCR adds some new provisions to the repeat monitoring 

requirements to provide flexibility to the States and PWSs. One of these changes is the 

additional flexibility provided to States regarding the waiver or the extension of the 24-hour limit 

for a PWS to collect repeat samples. States are given the option to describe in their primacy 

application the criteria they will use to waive or extend the 24-hour limit instead of making the 

decisions on a case-by-case basis. This is discussed further in section V of this preamble, State 

Implementation.

Another change is the use of alternative monitoring locations. As discussed in section III.C 

of this preamble, Monitoring, the PWS may propose alternative repeat monitoring locations that 

are expected to better characterize or identify pathways of contamination into the distribution 

system. Systems may elect to specify either alternative fixed locations or criteria for selecting 

their repeat sampling locations on a situational basis in a standard operating procedure (SOP), 

which is part of the sample siting plan. By allowing systems to specify criteria for selecting their 

repeat sampling locations in their SOP instead of setting fixed repeat sampling locations, systems 

can provide a more flexible and more protective response. The system can focus the repeat 

samples at locations that will best verify and determine the extent of potential contamination of 

the distribution system based on specific situations. For discussion on additional requirements 

on for alternative monitoring locations, see section III.C of this preamble, Monitoring.

There are also some modifications to the dual purpose sampling allowed under the GWR and 

1989 TCR. Under the RTCR, GgGround water systems (GWSs) required to conduct triggered 

source monitoring under both the RTCR and the GWR must take ground water source samples in 
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addition to the repeat samples required by the RTCR. However, a GWS ground water system

serving 1,000 or fewer people may use a repeat sample collected from a ground water source to 

meet both the repeat monitoring requirements of the RTCR and the source water monitoring 

requirements of the GWR (i.e., a dual purpose sample), but only if the State approves the use of a 

single sample to meet both rule requirements and the use of E. coli as a fecal indicator for source 

water monitoring. If the sample is E. coli-positive, the system violates the E. coli MCL under 

the RTCR and must also comply with the GWR requirements following a fecal indicator-positive 

sample. These provisions are consistent with the GWR.

If a system with a limited number of monitoring locations (such as a system with only one 

service connection or a campground with only one tap) takes more than one repeat sample at the 

triggered source water monitoring location, the system may reduce the number of additional 

source water samples by the number of repeat samples taken at that location that were not E. 

coli-positive. For example, if a system takes two dual purpose samples and one is E. colipositive and the other is E. coli-negative, the system has an E. coli MCL violation under the 

RTCR and is required to take four additional source water samples, rather than five, under the 

GWR (see 40 CFR 141.402(a)(3)). If the system takes more than one of these repeat samples at 

the triggered source water monitoring location and has more than one repeat sample that is E. 

coli-positive at the triggered source water monitoring location, then the system would have both 

an E. coli MCL violation under the RTCR and a second fecal indicator-positive source sample 

under the GWR. The system would then need to also comply with the GWR treatment technique 

requirements under 40 CFR 141.403.

Results of all routine and repeat samples not invalidated by the State must be used to 

determine whether the coliform treatment technique trigger has been exceeded (see section III.E 

Comment [EPA67]: Triggered source 

water monitoring is only required 

under the GWR. We made the 

changes in this sentence to clarify the 

issue.
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of this preamble, Coliform Treatment Technique, for a discussion of the coliform treatment 

technique triggers).

2. Key issues raised

A majority of the commenters supported the change from four to three repeat samples for 

systems serving 1,000 or fewer people. However, one commenter stated that decreasing the 

number of repeat samples would also lessen the likelihood of detecting total coliforms and E. 

coli. EPA explained the analysis that EPA has done to support the reduction in the number of 

repeat samples in the preamble to the proposed RTCR. In that analysis, using the Six-Year 

Review 2 data (USEPA 2010c), EPA showed that if the number of required repeats were reduced 

from four to three, there would still be almost as many (approximately 94 percent) situations 

leading to an assessment being triggered for the system. See section III.A.4 of the preamble to 

the proposed RTCR, Repeat Samples, for a detailed discussion of EPA’s analysis on the 

reduction of the number of repeat samples. Although dropping the required number of repeat 

samples from four to three means that some fraction of triggertriggered assessments may be 

missed, the other provisions of the RTCR compensate for that change and, taken as a whole, the 

provisions of the RTCR provide for greater protection of public health. One such provision 

includes enhanced consequences for monitoring violations. For example, systems that do not 

take all of their repeat samples under the RTCR are triggered to conduct a Level 1 assessment. 

This permits an increase in public health protection over the 1989 TCR because PWSs are 

required to assess their systems when lack of required monitoring results show that creates a 

situation where the PWS does not properly know whethermay be it is vulnerable to 

contamination (indicated by exceeding the trigger). Moreover, because of the substantial cost of 

this potential consequence, systems would be more likely to take all of their required repeat 

Comment [JL68]: Is this always the 

case?

Comment [EPA69]: Yes, as 

recommended in the AIP
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samples in the first place (see section III.E of this preamble, Coliform Treatment Technique, for 

additional discussion on the coliform treatment technique triggers).

EPA also received comments generally supporting the use of alternative sites for repeat 

monitoring since they provide more flexibility in determining the locations of the repeat samples, 

allowing for better protection of public health on a site-specific basis, subject to sState review. 

One commenter disagreed, saying that repeat samples should be near the original positive sample

site so that they can provide the necessary information to confirm the original positive sample. 

A few commenters are against having within-five-connections-upstream-and-downstream

locations from the original positive sample as the default locations for repeat monitoring. They 

suggested that these default locations should be eliminated altogether and that all PWSs be 

allowed to take the other two repeat samples at alternative locations. 

EPA believes that not all systems will use the option of taking repeat samples at alternative 

locations. Some PWSs, especially small NCWSs, may not avail themselves of this option for 

reasons of simplicity and lack of resources and expertise. They may elect to stick with the set 

repeat monitoring locations of five connections upstream and downstream of the original total 

coliform-positive sample, as it will be less burdensome on them than locating alternative sites 

and demonstrating that the alternative sites are more effective. Hence, EPA is maintaining 

within-five-connections-upstream-and-downstream locations as the default repeat sampling 

locations.

While the prescribed locations may work for some systems, other systems may find them too 

limiting. Taking repeat samples at the prescribed locations of within five-connections-upstreamand-downstream can be difficult for some systems to implement within the required 24 hours for 

a repeat sample because of issues such as access to the site. Therefore, EPA is allowing PWSs to 
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propose alternative repeat monitoring locations, either as fixed locations or as criteria in an SOP, 

to facilitate the identification of the source and extent of any problem. EPA believes that both 

the within-five-connections-upstream-and-downstream repeat sampling locations and the 

locations as identified by an SOP can be used by the operator to better understand the extent and 

duration of potential pathways of contamination into the distribution system with the appropriate 

amount of State supervision.

EPA requested comment on whether systems should be required to obtain prior State 

approval for using repeat monitoring sites other than the within-five-connections-upstream-anddownstream locations of the original routine total coliform-positive site. Most of the 

commenters were against requiring prior State approval for the use of alternative repeat 

monitoring locations. They suggested that it is more appropriate to include these sites (or the 

criteria to choose sites) in the SOP or in the sample siting plan, which is then subject to State 

review and approval and revision. Some commenters also stated that requiring pre-approval for 

each individual instance of using alternative sites is not practical.

EPA agrees that obtaining prior State approval to use alternative repeat monitoring locations 

is not necessary since there is no reduction in monitoring and EPA expects the SOP to be used 

only by large systems with the technical resources to justify alternative monitoring sites. 

Although State approval is not required, EPA requires PWSs that are intending to use this option 

to submit their proposed alternative sampling sites (as part of an SOP or the sample siting plan) 

to the State. The PWS must be able to demonstrate to the State that the alternative monitoring 

sites are appropriate to help characterize the extent of the possible contamination. The State is 

given the discretion to review and revise the alternative monitoring locations consistent with 

their practice regarding sample siting plans. EPA does not require that the State formally 

Comment [EPA70]: We added this 

because this is the wording in the 

current TCR and the RTCR.
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acknowledge and approve the alternative monitoring locations. The alternative monitoring 

locations are considered appropriate unless the State disapproves or modifies them, which results 

in the requirement being self-implementing.

EPA received general support for allowing samples taken at the ground water source to serve 

both as a triggered source sample under the GWR and as one of the repeat samples under the 

RTCR (i.e., as dual purpose samples). Some States said that this practice is already being done 

in their States and therefore should continue under the RTCR. Most commenters supported the 

provision with the understanding that the practice would somehow be approved by the subject to 

State (e.g., sample siting plan that has been approved by the State) approval. One commenter, 

however, disagreed with the provision and thought the PWS would not be collecting a sufficient 

number of repeat samples to represent the water quality in the distribution system if one of the 

repeat samples is taken at the source water. Another commenter suggested making the option 

available for ground water systems of all sizes, as it will help reduce labor and analytical costs, 

and will provide a clearer picture as to the location and cause of the total coliform-positive 

sample.

The preamble to the proposed RTCR discussed the drawbacks to allowing dual purpose 

samples i.e., a reduction in the number of repeats in the distribution system. By requiring State 

approval of the use of dual purpose sampling, only the RTCR ensures that this flexibility will 

only be allowed where the sState has determined it is appropriate systems will be allowed to do 

so. EPA believes that PWSs with limited or no distribution systems are the best candidates for 

approval since there is little to no chance of contamination from the distribution system except 

from cross connection. AccordinglyOn the other hand, EPA believes that dual purpose samples 

may not be appropriate for systems with extensive distribution systems systems because will not 
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be able to show that the reduction in monitoring (i.e., loss of aone less repeat sample in a 

distribution system that extends far from the that is near the total coliform-positive sample site, 

but not near the source water sample site) willmay not provide public health protection 

equivalent to taking separate samples.

EPA requested comment on whether the use of dual purpose samples should be allowed by 

simply including it in the sample siting plan, without prior State approval. As stated earlier, 

most of the comments supported allowing dual purpose sampling with the understanding that it 

will be somehow approved by the State. Some commenters, on the other hand, said that it should 

be allowed without prior State approval. One commenter said that the State may not be able to 

review and approve the sample siting plan until the next sanitary survey, which maybe as long as 

five years after the RTCR implementation. One commenter said that States should only be 

required to say that dual purpose sampling is not allowed for specific systems. Another 

commenter suggested to allowing States to explain their process of for approval in their primacy 

application, so that rather than each situation should not being handled on a case-by-case basis,

thereby reducing administrative burden.

As discussed earlier, EPA believes that requiring State approval for allowing dual purpose 

sampling limits the practice only to systems that can avail themselves of it without 

compromising public health protection. State approval is required because this constitutes a 

reduction in monitoring (no separate triggered source water samples), relative to requiring 

separate samples for compliance with the two rules. EPA believes this reduction in monitoring is 

appropriate only if the State determines that the dual purpose sample provides public health 

protection equivalent to that provided by separate repeat and source water samples. 

Comment [JL71]: Is this showing 

required by the RTCR? If not, 

reword.

Comment [EPA72]: Revised after the 

7/18 phone call
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As part of the special primacy requirements for the RTCR in § 142.16(q), States adopting the 

reduced monitoring provisions of the RTCR, including dual purpose sampling, must describe 

how they will do so in their primacy application package. States must include their approval 

process for dual purpose sampling in their application. This gives States the flexibility to 

determine how and when they want to grant approval, i.e., whether on a case-by-case basis 

(whenever a total coliform-positive occurs) or on a one-time regular pre-approved basis (i.e., the 

system has prior State approval to take a dual purpose sample whenever it is triggered to do 

source water monitoring). 

E. Coliform Treatment Technique 

1. Coliform treatment technique triggers

a. Requirements. The non-acute MCL violation for total coliforms under the 1989 TCR is 

replaced under the RTCR by a coliform treatment technique involving monitoring for total 

coliforms and assessment and corrective action when triggered. EPA is establishing an 

assessment process in the RTCR to strengthen public health protection. Under the 1989 TCR, a 

system is not required to perform an assessment following a monthly/ non-acute MCL violation 

or an acute MCL violation. Under the RTCR treatment technique framework, the presence of 

total coliforms is used as an indicator of a potential pathway of contamination into the 

distribution system. As discussed in section III.B of this preamble, Rule Construct: MCLG and 

MCL for E. coli and Coliform Treatment Technique, the RTCR eliminates the associated MCLG 

and MCL for total coliforms. The RTCR specifies two levels of treatment technique triggers, 

Level 1 and Level 2, and their corresponding levels of response. The degree and depth to which 

a PWS must examine its system and monitoring and operational practices, i.e., the difference 

between a Level 1 or Level 2 assessment, depends on the degree of potential pathway for 

Comment [EPA73]: Changed to 

“pre-approved” instead of regular; 

regular might imply that it has to 

happen more than once, which would 

not be the intention here.
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contamination. A Level 2 assessment requires a more in-depth and comprehensive review of the 

PWS compared to a Level 1. A discussion of the levels of assessments is found later in section 

III.E.2 of this preamble, Assessment.

The system has exceeded the trigger immediately once any of the following conditions have 

been met.

Level 1 treatment technique triggers

• For systems taking 40 or more samples per month, the PWS exceeds 5.0 percent total 

coliform-positive samples for the month; or

• For systems taking fewer than 40 samples per month, the PWS has two or more total 

coliform-positive samples in the same month; or

• The PWS fails to take every required repeat sample after any single routine total coliformpositive sample.

The first two treatment technique triggers were the conditions that define a non-acute MCL 

violation under the 1989 TCR. The third trigger provides incentive for systems to take their 

repeat samples to ensure that they are assessing the extent of the total coliform contamination; if 

they do not do so by repeat sampling, they must conduct an assessment instead to ensure there 

are no pathways to contamination (sanitary defects). Repeat monitoring is critical in identifying 

the extent, source, and characteristics of fecal contamination in a timely manner. EPA’s 

analysis, as discussed in the preamble to the proposed RTCR (see section III.A.4 of the preamble 

to the proposed RTCR, Repeat samples), shows that the average percentage of repeat samples 

that are positive is much higher than that of routine samples, demonstrating that when operators 

are required to take a second look at their systems following the positive routine sample, they 

find, on average, a higher rate of coliform presence than during routine sampling. In other 
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words, the high repeat total coliform positive rate indicates the persistence of total coliforms at 

such locations in the distribution system. Since under the RTCR there is no additional routine 

monitoring for systems that monitor at least monthly and the number of additional routine 

monitoring and repeat monitoring samples for the smallest systems that are not on monthly 

monitoring is decreased, the need to conduct repeat monitoring is more crucial than ever in 

providing immediate and useful information needed to protect public health.

Level 2 treatment technique triggers:

• The PWS has an E. coli MCL violation (see section III.F of this preamble, Violations, for a 

description of what constitutes an E. coli MCL violation); or

• The PWS has a second Level 1 treatment technique trigger within a rolling 12-month period, 

unless the initial Level 1 treatment technique trigger was based on exceeding the allowable 

number of total coliform-positive samples, the State has determined a likely reason for the 

total coliform-positive samples that caused the initial Level 1 treatment technique trigger, 

and the State establishes that the system has fully corrected the problem; or

• For PWSs with approved reduced annual monitoring, the system has a Level 1 treatment 

technique trigger in two consecutive years.

b. Key issues raised. EPA received comments that disagreed with the inclusion of the third 

Level 1 treatment technique trigger, i.e., failing to take every required repeat sample after any 

single routine total coliform-positive sample triggers a Level 1 assessment. Some of the 

commenters suggested that this does not pose a public health concern and should remain a 

monitoring violation because if a system does not conduct the required repeat monitoring, then it 

is doubtful that it will conduct the assessment. One commenter was concerned that a system 

might opt to conduct the assessment instead of taking the repeat samples and just indicate in the 

Comment [EPA74]: Added to 

address Jim’s comment below

Comment [JL75]: This is confusing 

since you have just said there is no 

additional routine monitoring.

Comment [JL76]: Suggest adding 

same state based discretion as in 

previous bullet. Situation is really no 

different.

Comment [EPA77]: Did not take 

suggestion. Both bullets describe 

conditions that are as recommended in 

the AIP, see page 19.The advisory 

committee wanted to hold systems on 

annual monitoring accountable, since 

they do so little monitoring and they 

should be assuring that the system is 

well operated. For systems on more 

frequent monitoring than annual, there 

was a concern that additional 

sampling and assessment could get 

ahead of the ability to correct defects; 

that would not occur with annual 

monitoring
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assessment form that no sanitary defect was found or the cause of the total coliform-positive 

sample could not be identified. The system then avoids the possibility of the repeat samples 

being total coliform- or E. coli-positive. They commented that since the Level 1 assessment is 

done by the system, doing the assessment will also be cheaper than taking the repeat samples.

EPA disagrees that the PWS will avoid taking repeat samples because of economic reasons. 

EPA’s analysis indicates that a Level 1 assessment costs about four times as much as taking three 

repeat samples (see Exhibits 3-12 and 4-7 of the Technology and Cost Document for the Final 

Revised Total Coliform Rule (USEPA 2012b)). States also must review the assessment form 

submitted by the PWS. If the assessment and/or corrective action is/are not acceptable to the 

State, the State can require the PWS to redo the assessment and submit a revised assessment 

form. EPA also expects that in situations where the cause of the total coliform- or E. colipositive result cannot be identified, the PWS will arrived at this conclusion only after due 

diligence on its part (i.e., the system adheres to proper procedures and standards set by the State 

in conducting the assessment). The State may require the PWS to provide supporting 

documentation and analyses to back-up its finding. Because of the cost and the effort involved 

in conducting a Level 1 assessment, EPA expects that systems will want to ensure that 

assessments are conducted only when potential problems may exist rather than for failure to take 

repeat samples. 

One commenter suggested that EPA clarify that collecting samples outside the 24-hour 

required time is not a Level 1 trigger as there are instances when the repeat samples cannot be 

collected within 24 hours of the routine total coliform-positive sample. EPA notes that there is a 

provision in the RTCR, § 141.858(a)(1), that allows the State to extend the 24-hour limit on a 

case-by-case basis if the system has a logistical problem in collecting the repeat samples within 
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24 hours that is beyond its control. In such cases when the State allows the system to collect the 

repeat samples beyond the 24 hours, the system does not trigger a Level 1 assessment. 

One commenter suggested that EPA include an additional provision that an assessment need 

not be triggered if the total coliform-positive occurred when there are representative levels of 

disinfectant residual in the distribution system, stating that historical total coliform-positive 

results occurred with normal levels of chlorine residuals in the distribution system and did not 

cause any waterborne disease. EPA disagrees that there is no public health risk in this situation. 

The fact that total coliforms can be detected even in the presence of a disinfectant residual is an

indication that there might be a bigger, hidden problem that needs further investigation. An 

assessment is warranted to determine if there exists a potential pathway of contamination into the 

distribution system and corrective action is warranted if a sanitary defect is identified.

EPA received comments to eliminate the Level 2 treatment technique trigger where a second 

Level 1 assessment is triggered within a rolling 12-month period, or for systems on annual 

monitoring, where two Level 1 assessments in two consecutive years trigger a Level 2 

assessment. Some of the commenters thought that many small systems will be triggered to 

conduct a Level 2 assessment multiple times. EPA believes that although the conditions (i.e., a 

second Level 1 trigger) that lead to the Level 2 trigger do not necessarily pose an immediate 

acute public health threat, it may still pose a potential serious health impact because of the 

persistence of the contamination and the failure of the system to address it. EPA believes that a

Level 2 assessment is warranted in this case because a more in-depth examination of the system 

is needed to determine the cause of the persistent occurrences of total coliforms. EPA also notes 

that, ideally, a well-performed Level 1 assessment and appropriate corrective action will prevent 

most systems from developing conditions that lead to a Level 2 assessment.
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2. Assessment 

a. Requirements. There are two levels of assessment based on the associated treatment 

technique trigger: Level 1 assessment for a Level 1 treatment technique trigger and Level 2 

assessment for a Level 2 treatment technique trigger. At a minimum, both Level 1 and 2 

assessments must include review and identification of the following elements:

• Atypical events that may affect distributed water quality or indicate that distributed water 

quality was impaired;

• Changes in distribution system maintenance and operation that may affect distributed water 

quality, including water storage;

• Source and treatment considerations that bear on distributed water quality, where 

appropriate; 

• Existing water quality monitoring data; and

• Inadequacies in sample sites, sampling protocol, and sample processing.

The system must conduct the assessment consistent with any State directives that tailor 

specific assessment elements with respect to the size and type of the system and the size, type, 

and characteristics of the distribution system. The PWS must complete the assessment as soon 

as practical after the PWS learns it has exceeded a treatment technique trigger. Failure to 

conduct a triggered assessment is a treatment technique violation. See section III.F.1.b of this 

preamble, Coliform treatment technique violation.

Level 1 assessment

A Level 1 assessment must be conducted when a PWS exceeds one or more of the Level 1 

treatment technique triggers specified previously. Under the rule, this self-assessment consists of 

a basic examination of the source water, treatment, distribution system and relevant operational 
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practices. The PWS might should look at conditions that could have occurred prior to and 

caused the total coliform-positive sample. Example conditions include treatment process 

interruptions, loss of pressure, maintenance and operation activities, recent operational changes, 

etc. In addition, the PWS might should check the conditions of the following elements: sample 

sites, distribution system, storage tanks, source water, etc. 

Level 2 assessment 

A Level 2 assessment must be conducted when a PWS exceeds one or more of the Level 2 

treatment technique triggers specified previously. It is a more comprehensive examination of the 

system and its monitoring and operational practices than the Level 1 assessment. The level of 

effort and resources committed to undertaking a Level 2 assessment is commensurate with the 

more comprehensive investigation and review of available information, and engages additional 

parties and expertise relative to the Level 1 assessment. Level 2 assessments must be conducted 

by a party approved by the State: the State itself, a third party, or the PWS where the system has 

staff or management with the required certification or qualifications specified by the State. If the 

PWS or a third party conducts the Level 2 assessment, the PWS or third party must follow the 

State requirements for conducting the Level 2 assessment. The PWS must also comply with any 

expedited actions or additional actions required by the State in the case of an E. coli MCL 

violation.

Assessment forms

The PWS must submit the completed assessment form for either a Level 1 or Level 2 

assessment to the State for review within 30 days after the PWS learns that it has exceeded the 

trigger. Failure to submit the completed assessment form after the PWS properly conducts the 

assessment is a reporting violation (see section III.F.1.d of this preamble, Reporting violation). 

If the State determines that the assessment is insufficient, the State will consult with the PWS. If 
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the State requires revisions after consultation, the PWS must submit a revised assessment to the 

State on an agreed-upon schedule not to exceed 30 days from the date of the initial consultation. 

The completed assessment form must include assessments conducted, all sanitary defects 

found (or a statement that no sanitary defects were identified), corrective actions completed, and 

a proposed timetable for any corrective actions not already completed. Upon completion and 

submission of the assessment form by the PWS to the State, the State must determine if the 

system has identified the likely cause(s) for the Level 1 or Level 2 treatment technique trigger 

and, if so, establish that the system has corrected the problem(s). Whether or not the system has 

identified any sanitary defects or a likely cause for the trigger, the State may determine whether 

or not the assessment is sufficient, and if it is not, the State must discuss its concerns with the 

system. The State may require revisions to the assessment after the consultation.

b. Key issues raised. The RTCR requires assessments to identify whether potential 

pathways of contamination into the distribution system exist after monitoring results indicate the 

system has exceeded a trigger. However, some commenters disagreed that requiring assessments 

will result in better public health protection. For one, they stated that assessments are already 

occurring under the 1989 TCR; hence, there is no need to formally require them. Second, 

assessments conducted by small systems will not likely be adequate as these systems usually do 

not have the resources and the capability to conduct a proper assessment. The States will then 

have to perform the assessments themselves (even the Level 1 assessments), thus adding to State 

burden. Third, assessments will reduce follow-up sampling and will allow a PWS to “guess 

assess” the cause of the positive sample.

EPA agrees that there already is some level of assessment and corrective action being 

performed voluntarily by proactive systems, and accounted for this fact in the economic analyses 

Comment [JL78]: What happens if 

the system has not identified the likely 

cause, or the state does not think it 

has?

Comment [EPA79]: 

JL: “Consult” seems out of place here 

since it usually has the connotation of 

getting advice from the other party. 

Here it is the state that is providing the 

advice and expertise, not the system. 

What does the rule text say?

EPA – AIP says “consult”, as does 

rule text on pages 300 and 301, see 

highlighted text on those pages.

EPA agreed to change “consult” to 

“discuss its concerns” here but 

OMB agreed that we could leave the 

rule language “consult.”

Comment [EPA80]: To address 

comment above, and as edited on 7/18 

phone call. See pages 18 and 19 of the 

AIP and section 141.859 of the RTCR
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for the final RTCR (see chapter 7.4.5 of the RTCR EA (USEPA 2012a), Assessments). 

However, not all systems are proactive in addressing the probable cause(s) of the positive 

samples. Under the 1989 TCR, when a system has an MCL violation and any subsequent 

sampling did not detect total coliforms, the problem may persist despite the subsequent negative 

samples due to the intermittent nature of microbial contamination and may remain unaddressed. 

By requiring PWSs to assess their systems when they are triggered to do so, the RTCR aims to 

build and strengthen the capability of PWSs in ensuring that their systems maintain their 

integrity and that barriers are in place and are effective. These actions would will better protect 

public health than the additional monitoring with no assessment and corrective action that is 

allowed under the 1989 TCR.

EPA acknowledges that small systems, especially small NCWSs may not have the 

knowledge and the resources that other systems, like CWSs, have. However, most small 

NCWSs are simple systems that often consist of just the source water and a limited distribution 

system. EPA anticipates then that the level of effort and expertise needed to conduct a Level 1 

assessment at these systems will not be considerable. At a minimum, the Level 1 assessment 

should be conducted or managed by a responsible party of the PWS. While EPA does not expect 

the Level 1 assessor to be an expert in the requirements of SDWA, the assessor should be 

someone familiar enough with the system to answer the questions in the Level 1 assessment form 

or to gather correct information from others who work for the system.

To help in the implementation burden of the assessment, a PWS may conduct a Level 1

assessment while it consults with the State by phone. This is in lieu of having the State 

physically perform the assessment when the PWS needs assistance. Generally, Tthe PWS would 

still need to fill-out the assessment form and submit it to the State. The State would still need to 
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review the form but the process will not take as much effort as previously anticipated since the 

State would already be familiar with that particular assessment. It is also possible permissible

that the State fills out the form while the PWS consults with the State by phone when doing the 

assessment. The State may also want to set up alternative methods for the PWS to submit the 

assessment form, such as via an online submission or email. The State should document its 

process in the primacy application. Whatever process the State adopts should be documented in 

its primacy application. 

EPA disagrees that the assessment requirements will reduce follow-up sampling. PWSs are 

still required to take repeat samples following a routine total coliform-positive sample. PWSs on 

quarterly or annual monitoring must conduct additional routine monitoring the month following 

the total coliform-positive sample. In addition, nothing in the treatment technique requirements 

precludes a PWS from taking additional compliance samples or special purpose samples such as 

those taken to determine whether disinfection practices are sufficient following pipe replacement 

or repairs (see § 141.853(b) of the RTCR). 

EPA disagrees that PWSs conducting the assessment will “guess assess” the cause of the 

positive samples. Conducting an assessment is a methodical process that requires a PWS to 

evaluate the different elements of its operation and distribution system (§ 141.859(b)(2) of the 

RTCR specifies the minimum elements that an assessment must have, keeping in mind that some 

of the elements may not be applicable to some PWSs like small NCWSs). The RTCR requires 

that an assessment form be completed. The assessment form should help and guide the PWS in 

conducting the assessment by laying out the different elements the PWS must look into. EPA 

provides examples of assessment forms that States and PWSs can use to help them in conducting 

the assessment (these examples are given in Appendix X of the AIP (USEPA 2008x2008c) and 

Comment [EPA81]: Edited, as 

discussed on the 7/18 phone call and 

suggested by OMB 7/25
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in Appendix A of the Proposed Revised Total Coliform Rule Assessments and Corrective Actions 

Guidance Manual – Draft (USEPA 2010d)). EPA also acknowledges that an assessment will not 

always identify sanitary defects or find a reason or cause for the presence of total coliforms 

and/or E. coli. In such cases, the PWS must document that fact in the completed assessment 

form. This, however, is not “guess assessing” as EPA expects that only PWSs that adhere to 

proper procedures and standards set by the State are eligible to arrive at this determination. It is 

then the responsibility of the State to determine if the assessment was acceptable.

Some commenters suggested that for systems with limited distribution systems that have a 

first Level 1 trigger, the Level 1 assessment should be delayed and the focus of the evaluation 

should be on the source water, and the Level 1 assessment should only be conducted if there is

another Level 1 trigger. 

The system may conduct an integrated assessment that meets the requirements of all 

applicable rules, such as the GWR and the RTCR, as long as the assessment is consistent with 

any State directives that tailor specific assessment elements with respect to the size and type of 

the system and the size, type, and characteristics of the distribution system, as required under § 

141.859(b)(2) of the RTCR. EPA further notes that source water issues are one of the elements 

that need to be considered in a Level 1 (or 2) assessment where they may be a contributing factor 

to a coliform exceedeance or other trigger. EPA expects that assessments at PWSs with limited 

or no distribution systems will be relatively simple assessments at relatively simple systems and 

can easily be integrated tailored to meet all applicable requirements of both the GWR and the 

RTCR. EPA will address this in the revised Revised Total Coliform Rule Assessment and 

Corrective Actions Guidance Manual that is being developed.

Comment [EPA82]: OK with these 

OMB edits
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EPA received comments both in support and against having two levels of assessment. The 

commenters in the second category concluded that both levels of assessment would involve the 

same effort. There were comments to eliminate the Level 1 assessment and emphasize the Level 

2 assessment, as the Level 1 assessment will not lead to any meaningful evaluation and will only 

take up the State’s resources. EPA disagrees that there is no need for two levels of assessment. 

The RTCR requires two levels of assessment to recognize that a higher level of effort to diagnose 

a problem should be applied to situations of greater potential public health concern such as 

repeated Level 1 triggers or an E. coli MCL violation. A Level 1 assessment is not as 

comprehensive as Level 2 assessment. This however, does not negate the importance of a Level 

1 assessment. Triggers that lead to a Level 1 assessment may indicate the possibility of a breach 

of the barriers in place. It is important that PWSs ensure that these barriers remain intact by 

performing the assessment. 

EPA received comments that the qualifications of assessors are not clear in the rule. The 

commenters suggested including the qualifications in the rule or referencing the qualifications 

described in the Proposed RTCR Assessment and Corrective Actions Guidance Manual – Draft

(USEPA 2010d). Some commenters concluded that the Level 2 assessment will require a whole 

new certification program for assessors. Others concluded that the States will end up doing the 

Level 2 assessment because of what is expected and required of a Level 2 assessment. On the 

other hand, one commenter suggested that a system operator should be certified to perform an 

assessment of their own system. Another suggested that States be allowed to set mechanisms in 

place to ensure that a Level 2 assessment is performed more comprehensively than a Level 1 

assessment.
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EPA does not require that a separate certification program be established to determine who 

can perform a Level 2 assessment. Instead of being prescriptive on who can conduct a Level 2 

assessment, EPA is allowing the State to determine its criteria and process for approval of Level 

2 assessors and to determine who is appropriate to conduct the assessment given the State’s 

knowledge of the complexity of the system and the knowledge and policies of the State. 

Although the rule allows that certified operators may perform a Level 2 assessment if approved 

by the State, EPA recommends that States consider whether having the assessment done by 

someone from outside the system can provide a fresh perspective. Qualified certified operators 

can be allowed to conduct assessments at other systems. 

EPA requested comments on how to ensure that a Level 2 assessment is more comprehensive 

than a Level 1 assessment (e.g., by possibly including asset management and capacity 

development). EPA asked in the proposed rule whether EPA should provide more detail in 

guidance or rule language, on the elements and differences between a Level 1 and Level 2 

assessment. A Mmajority of the commenters were against the inclusion of asset management 

and capacity development in the Level 2 assessment. EPA received comments stating that the 

proposed rule language regarding the two levels of assessment was adequate and that additional 

discussion about the differences between the two should instead be addressed in guidance. One 

commenter, on the other hand, said that there was no difference in the scope between the two 

assessments based on the way the proposed rule language was written.

EPA defined in § 141.2 both a Level 1 assessment and a Level 2 assessment to provide a 

better distinction between the two levels of assessment and facilitate the implementation of the 

RTCR. See section III.A.1 of this preamble, Assessment, for the definitions of a Level 1 and 

Level 2 assessment. EPA is also requiring States to describe in their primacy application how 
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they will ensure that a Level 2 assessment is more comprehensive than a Level 1 assessment; 

thus, giving the States more flexibility in implementing the rule. EPA released the Proposed 

Revised Total Coliform Rule Assessments and Corrective Actions Guidance Manual – Draft

(USEPA 2010d) in August 2010 to help stakeholders understand the difference between the two 

levels of assessment. EPA will revise this guidance manual based on the comments received and 

release it soon after the final RTCR is published in the Federal Register.

EPA received comments to allow the extension of the assessment period beyond 30 days. A 

commenter suggested that intermediate deadlines for a Level 2 assessment triggered by the 

presence of E. coli be included because of the acute nature of the threat.

EPA expects that the PWS will conduct an assessment as soon as practical after the PWS 

receives notice or becomes aware that the system has exceeded a trigger. EPA imposes a 30-day 

limit because the possible occurrence of contamination, as indicated by the conditions that 

trigger the assessment, must be addressed immediately. The system has 30 days from the time it 

learns of exceeding the trigger to conduct the assessment and complete the corrective action. 

EPA believes that the 30-day period is sufficient time for problem identification and potential 

remediation of the problem in conjunction with the follow-up assessment in most cases. The 

system can work out a schedule with the State to complete the corrective action if more time is 

needed. It is very important, however, that the assessment is conducted as soon as possible 

within those 30 days. In the case of an E. coli MCL violation, the system must comply with any 

expedited actions or additional actions required by the State (see § 141.859(b)(4) of the RTCR). 

EPA also encourages PWSs to submit their completed assessment forms as soon as possible and 

not wait until the end of the 30-days to do so.

3. Corrective action
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a. Requirements. Under the RTCR, PWSs are required to correct sanitary defects found 

through either a Level 1 or Level 2 assessment. Systems should ideally be able to correct any 

sanitary defects found in the assessment within 30 days and report that correction on the 

assessment form. This is especially important when E. coli has been detected in samples 

collected from the distribution system, indicating that a potential health hazard exists. However, 

EPA recognizes that correcting sanitary defects within 30 days may not always be possible due 

to the extent and cost of the corrective action, and that some systems therefore may not be able to 

fix sanitary defects before submitting the completed assessment form within the 30-day interval. 

When the correction of sanitary defects is not completed by the time the PWS submits the 

completed assessment form to the State, EPA encourages the State and PWS to work together to 

determine the appropriate schedule for corrective actions (which may include additional or more 

detailed assessment or engineering studies) to be completed as soon as possible. The schedule, 

which is approved by the State, must include when the corrective action will be completed and 

any necessary milestones and temporary public health protection measures. The PWS must 

comply with this schedule and notify the State when each scheduled corrective action is 

completed.

At any time during the assessment or corrective action phase, either the PWS or the State 

may request a consultation with the other entity to discuss and determine the appropriate actions 

to be taken. The system may consult with the State on all relevant steps that the system is 

considering to complete the corrective action, including the method of accomplishment, an 

appropriate timeframe, and other relevant information. EPA is not requiring this to be a 

mandatory consultation to provide ease of implementation for States. In many cases, 
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consultation may not be necessary because the type of corrective action for the sanitary defect 

will be clear and can be fixed implemented right away (e.g., replacement of a missing screen).

b. Key issues raised. EPA received comments that not all sanitary defects should have to be 

corrected unless it can be determined the defect directly correlates to the trigger or if the defect is 

otherwise regulated. Similarly, commenters suggested that EPA clarify that any requirement to 

correct sanitary defects found during the assessment be limited only to issues that are within the 

system’s control. In contrast, one commenter encouraged EPA to provide authority to States to 

require broader corrective actions beyond fixing specific sanitary defects (e.g., requiring 

development and implementation of a storage tank inspection and maintenance plan).

EPA acknowledges that it may or may not be possible to conclusively link the total coliform-

/E. coli-positive sample to a given sanitary defect due to the complexity of the distribution 

system configuration and transport of contaminants throughout the system. That being the case, 

the PWS must still correct all sanitary defects found through the assessment even if the defect 

cannot be proven to be the likely cause of the positive sample, to prevent the defect from 

providing a pathway for future contamination. The RTCR takes a more preventive approach to 

protect public health by requiring that systems perform an assessment of their system when their 

monitoring results indicate a potential pathway of contamination into the distribution system, or 

a breach in the barriers that are in place, and correct those any all identified sanitary defects, 

regardless of whether the defect is directly related to the positive sample or not. This is because 

EPA believes that correcting only sanitary defects that are correlated to the positive sample is not 

sufficiently protective of public health. Uncorrected sanitary defects may provide a pathway for 

future incidences of contamination.

Comment [EPA83]: Revised as 

discussed on 7/18 phone call
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The RTCR requires that sanitary defects be corrected but does not mandate how the defects 

are to be corrected. States and PWSs may have other authorities under local ordinances and 

State laws that they may use to address the problem. For example, in cases where the location of 

the sanitary defect is outside the normal control of the PWS (e.g., cross connection occurring on 

private property), community water systems that are part of the local government may have some 

authority to address the problem under the public health code if the issue is affecting the water in 

the distribution system (AWWA 2010) or through other local ordinances such as plumbing 

codes. EPA encourages States and PWSs to work together to determine the best course of action 

when correcting sanitary defects.

Some commenters said that it is unclear how a water utility should demonstrate that it has 

corrected a sanitary defect and how the primacy agency would take enforcement action on any 

defects identified by the system. One commenter suggested that EPA clarify whether a sanitary 

defect would be considered corrected if subsequent samples are total coliform-negative. EPA 

notes that because of the intermittent nature of microbial contamination, it may not be adequate 

to just rely on follow-up samples to verify that the problem has been corrected or has gone away. 

Depending on the nature of the sanitary defect, States may require additional measures to ensure 

that the integrity of the distribution system has been restored (e.g., pressure monitoring, followup inspection of tanks, etc.). States have discretion on how to determine that defects have been 

corrected (e.g., site visits, sanitary surveys, etc.). Failure to correct identified sanitary defects is 

a treatment technique violation and States are expected to use their legal authority to take 

enforcement action to return the system to compliance.

F. Violations

1. Requirements
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EPA is establishing the definition of the following violations – MCL violation, treatment 

technique violation, monitoring violation, and reporting violation – consistent with the proposed 

RTCR. Each type of violation requires public notice, the level of which depends on the severity 

of the violation (see section III.G of this preamble, Providing Notification and Information to the 

Public, for information on public notification), and may trigger a system on reduced monitoring 

to increase its monitoring frequency (see section III.C of this preamble, Monitoring, for 

information on monitoring frequency). In addition to these violations, systems are required to 

comply with all the requirements of the RTCR, e.g., to use an approved analytic method to test 

for total coliforms and E. coli, to monitor according to a sample siting plan, etc. EPA also would 

like to clarify that exceeding a trigger and being required to conduct an assessment is not a 

violation by itself; as described later in this section, a violation occurs when a system exceeds the 

trigger but takes no does not take the required does not complete the required assessment and 

corrective action in response. 

a. E. coli MCL violation. A system incurs an E. coli MCL violation if any of the following 

occurs:

• A routine sample is total coliform-positive and one of its associated repeat samples is E. colipositive.

• A routine sample is E. coli-positive and one of its associated repeat samples is total coliformpositive.

• A system fails to take all required repeat samples following a routine sample that is positive 

for E. coli.

• A system fails to test for E. coli when any repeat sample tests positive for total coliforms.

Comment [EPA84]: Edited as ok’d 

on the 7/18 phone call
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b. Coliform treatment technique violation. A system incurs a coliform treatment technique 

violation when any of the following occurs:

• A system fails to conduct a required assessment within 30 days of notification of the system 

exceeding the trigger (see section III.E of this preamble, Coliform Treatment Technique, for 

conditions under which monitoring results trigger a required assessment).

• A system fails to correct any sanitary defect found through either a Level 1 or 2 assessment 

within 30 days (see also section III.E of this preamble, Coliform Treatment Technique) or in 

accordance with State-derived schedule.

• A seasonal system fails to complete a State-approved start-up procedure prior to serving 

water to the public. This is further discussed later on in the Key issues raised part of this 

section.

There is no treatment technique violation associated solely with a system exceeding one or 

more action triggers (Level 1 or Level 2 triggers).

c. Monitoring violation. A system incurs a monitoring violation when any of the following 

occurs:

• A system fails to take every required routine or additional routine sample in a compliance 

period.

• A system fails to test for E. coli following a routine sample that is total coliform-positive.

d. Reporting violation. A system incurs a reporting violation when any of the following 

occurs :

• A system fails to timely submit a monitoring report or a correctly completed assessment form 

after it properly monitors or conducts an assessment by the required deadlines. The PWS is 

Comment [JL85]: If the system never 

tests for e coli, it can never get an 

MCL violation, only a monitoring 

violation. Is this a concern?

Comment [EPA86]: This was 

established as a monitoring violation, 

whereas failing to analyze for e. coli 

after a repeat sample is an MCL 

violation. This was recommended by 

the advisory committee. Monitoring 

violation counts toward the 

assessment trigger and for some 

systems can lead to monthly 

monitoring. State may not waive this 

monitoring violation.
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responsible for reporting this information to the State regardless of any arrangement with a 

laboratory. 

• A system fails to timely notify the State following an E. coli-positive sample. See section 

III.H.1.a of this preamble, Reporting, for reporting requirements in the case of an E. colipositive sample.

• A seasonal system fails to submit certification of completion of State-approved start-up 

procedure. This is further discussed in the Key issues raised part of this section.

2. Key issues raised

EPA received comments that supported the proposed definition of the violations. Others 

offered suggestions to ease implementation burden. For example, one commenter recommended 

that only one violation be generated for each compliance situation (i.e., if an MCL violation is 

determined, then neither treatment technique, nor monitoring, nor reporting violation can be 

generated; if a treatment technique violation is determined, then neither monitoring nor reporting 

violation can be generated). However, EPA believes that it is important to track each of these 

situations individually so that the State can be aware of the system’s progress resolving situations 

and complying with all rule requirements. Each situation is also accompanied by public 

notification requirements so that consumers can be aware of problems at the water system and 

the progress and efforts to correct them. EPA believes it is important to continue to notify the 

public of each situation. 

Some commenters were uncertain about when failure to take all repeat samples triggers the 

associated Tier 1 PN (i.e., when the 24-hour clock starts). Some questioned how the State will 

know when the failure to collect these repeats has occurred in such a way to assure timely Tier 1 

PN when the sample results do not need to be reported until the 10th day of the month following 
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the month in which the samples were collected. EPA believes that State programs have been 

designed to address timely response to follow-up requirements such as the need to take repeat 

samples, through education, compliance assistance, and tracking and enforcement programs. 

The time limit is established to assure that systems act promptly to investigate positive samples. 

Some States require direct electronic reporting of results, which provides for more timely 

notification, and EPA encourages such practice. In the situations where it is not possible for the 

system to take the repeat samples within 24 hours, States have the discretion to waive the 

requirement (see section III.D of this preamble, Repeat Samples). 

Other commenters suggested adding to the list of violations. EPA received comment that 

there should be a violation when a seasonal system fails to perform the start-up procedure. EPA 

agrees and is designating such failure as a treatment technique violation. EPA is also requiring 

seasonal systems to certify that they have completed the start-up procedure and submit this 

certification to the State. Failure to do so is a reporting violation. EPA believes that performing 

start-up procedures is very important to mitigate the possible risks resulting from the seasonal 

system being shutdown, depressurized, or drained. Designating such failure as a violation will 

compel seasonal systems to make sure that they take the necessary steps to mitigate public health 

risks before serving water to the public.

Other commenters, on the other hand, suggested deleting the MCL violation resulting from 

failure to take all required repeat samples following a routine E. coli-positive sample. One 

commenter suggested that instead of an MCL violation, this should be considered a sanitary 

defect that requires corrective action. EPA considers E. coli as an indicator of a potential 

pathway of fecal contamination and that should be taken seriously. A system needs to follow up 

with repeat samples to characterize the extent and source of such contamination. Failure to take 

Comment [JL87]: OK, but why do 

you need the reporting requirement.

Comment [EPA88]: Was 

recommended in the AIP as “must 

demonstrate completion.”

JL: See earlier comment on this issue 

(page 62)

JL withdrew comment on 7/25
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the required repeat samples following an initial E. coli-positive sample is not protective of public 

health and is a serious violation. Making such failure an E. coli violation prevents a system from 

incurring only a monitoring violation when there is an indication of fecal contamination. 

Some commenters do not agree with the treatment technique violation because they do not

agree that the treatment technique requirements of the RTCR are appropriate. For a discussion 

on the treatment technique, see section III.E of this preamble, Coliform Treatment Technique. 

One commenter asked for clarification on whether failure to submit the assessment form within 

30 days is a treatment technique violation. As stated previously, this is a reporting violation, not 

a treatment technique violation, if the assessment has in fact been completed and the only failure 

was in submitting the required form. A treatment technique violation occurs when a potential 

pathway of contamination into the distribution system is unexplored and/or uncorrected. A 

system that neglects to perform the prescribed assessment or corrective action within schedule is 

in violation of the treatment technique requirement. 

Commenters also supported EPA’s proposal of separating the combined monitoring and 

reporting violation under the 1989 TCR into two separate violations. One commenter noted that 

it has been difficult to determine the significance of a violation when two types of violations –

monitoring and reporting – are captured and reported under only one heading. It is, therefore, 

difficult to develop performance measures and ensure data quality when the two violations are 

combined.

G. Providing Notification and Information to the Public

1. Requirements

EPA is promulgating changes to the public notificatione (PN) requirements contained in 40 

CFR part 141 subpart Q to correspond to the violation provisions of the RTCR (see section III.F 
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of this preamble, Violations). EPA is requiring a Tier 1 PN for an E. coli MCL violation, Tier 2 

PN for a treatment technique violation for failure to conduct assessments or corrective actions, 

and a Tier 3 PN for a monitoring violation or a reporting violation. 

Tier 1 PN is required for NPDWR violations and situations with significant potential to have 

serious adverse effects on human health as a result of short-term exposure, such as could occur 

with exposure to fecal pathogens. Tier 1 PN is required as soon as possible but no later than 24 

hours after the system learns of the violation. An E. coli MCL violation indicates possible 

exposure to pathogens in drinking water that can possibly result in serious, acute health effects, 

such as diarrhea, cramps, nausea, headaches, or other symptoms and possible greater health risks 

for infants, young children, the elderly, and people with severely compromised immune systems.

In the 1989 TCR, if a system has an acute MCL violation, which is based on the presence of 

fecal coliforms or E. coli, or the system’s failure to test for fecal coliforms or E. coli following a 

total coliform-positive repeat sample, the system is required to publish Tier 1 PN. Under the 

RTCR, a system is required to publish Tier 1 PN when it has an E. coli MCL violation. (See 

section III.F of this preamble, Violations, for a discussion of MCL violations.) In addition, the 

system will continue to be required to notify the State after learning of an E. coli-positive 

sample, as required under the 1989 TCR. As mentioned earlier in section III.B of this preamble, 

Rule Construct: MCLG and MCL for E. coli and Coliform Treatment Technique, EPA is 

eliminating the MCL for fecal coliforms. Under the RTCR, the standard health effects language, 

which is required to be included in all public notification actions, is modified to delete the 

reference to the fecal coliform MCL and fecal coliforms. The language for a non-acute violation 

under the 1989 TCR is modified to apply to a violation of the assessments and corrective action 

requirements of the coliform treatment technique.
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Tier 2 PN is required for all NPDWR violations and situations with potential to have serious 

adverse effects on human health not requiring Tier 1 PN. The system must provide public notice 

as soon as practical, but no later than 30 days after the system learns of the violation. A 

treatment technique violation under the RTCR meets these criteria because it is an indication that 

the public water system failed to protect public health when the system failed to conduct an 

assessment or complete corrective action following identification of sanitary defects. Sanitary 

defects indicate that a potential pathway may exist in the distribution system that has potential to 

cause public health concern.

In the 1989 TCR, a system is required to publish a Tier 2 PN when the system has a nonacute MCL violation, which is based on total coliform presence. Under the RTCR, a system is 

required to publish a Tier 2 PN if the system violates the coliform treatment technique 

requirements. Also, EPA is modifying the standard health effects language for coliform to 

emphasize the assessment and corrective action requirements of the RTCR.

Tier 3 PN is required for all other NPDWR violations and situations not included in Tier 1 or 

Tier 2. The existing Tier 3 PN requires a system to provide public notice no later than one year 

after the system learns of the violation or situation or begins operating under a variance or 

exemption. . Monitoring violations and reporting violations have historically been designated as 

Tier 3 PN unless an immediate public health concern has been identified (e.g., failure to monitor 

for E. coli after a Ttotal Ccoliform-positive sample requires a Tier 1 notification.) meet these 

criteria because, while they represent a violation of the RTCR, the risk to public health is not as 

clearly linked as immediate as for violations those that are Tier 1 or 2. ThereforeWhere no such 

immediate public health concern has been identified, EPA believes that a public notice given at 

Comment [EPA89]: Revised as 

discussed on 7/18 call. 

Text as revised by Jim had read 

“Monitoring violations and reporting 

violations meet these criteria because, 

while they represent a violation of the 

RTCR, the risk to public health is not 

as immediate as for violations that are 

Tier 1 or 2.”
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least annually for monitoring and reporting violations fulfills the public’s right-to-know about 

these violations.

In the 1989 TCR, a system is required to publish a Tier 3 PN when the system has a 

monitoring and reporting violation. In the RTCR, monitoring violations are considered distinct 

from reporting violations. Both types of violations require Tier 3 PN. 

Consumer confidence report (CCR) requirements are also modified. Health effects language 

for the CCR for total coliforms and E. coli, which is identical to the health effects language 

required for PN, is updated in the same way as described for PN. In addition, the RTCR 

removes the CCR requirements that require for the inclusion of total numbers of positive 

samples, or highest monthly percentage of positive samples for total coliforms as well as total 

number of positive samples for fecal coliforms. These provisions are replaced by requirements 

to include the number of Level 1 and Level 2 assessments required and completed, the number of 

corrective actions required and completed, the reason(s) for conducting assessments and 

corrective actions, and the total number of positive samples for E. coli. A system that fails to 

complete all the required assessments or correct all identified sanitary defects has a treatment 

technique violation and must identify it in the CCR as: (1) failure to conduct all of the required 

assessment(s); and/or (2) failure to correct all identified sanitary defects. A system that has an 

MCL violation must also include the condition that resulted in the MCL violation (see section 

III.B.1 of this preamble, MCLG and MCL, and § 141.860(a) of the RTCR). Unchanged and 

consistent with the provisions under the 1989 TCR, a CWS may provide Tier 3 PN using the 

annual CCR.

Consumer confidence reportCCR requirements are updated to reflect the advisory 

committee’s recommendations that total coliforms be used as an indicator to start an evaluation 

Comment [EPA90]: Edited by OMB 

7/25, ok.

Comment [JL91]: Was this all in the 

AIP?

Comment [EPA92]: AIP language: 

“The TCRDSAC recommends that 

EPA propose and request public 

comment on a revision to public 

notification and Consumer Confidence 

Report language consistent with 

existing provisions in subpart Q and 

O to 40 CFR 141 that reflect the use 

of TC as an indicator and the 

provisions for a treatment technique. 

Consistent with recommendations in 

Section 2.0, the TCRDSAC 

recommends that the opportunities for 

public comment include a stakeholder 

meeting.”

We proposed all of the listed 

requirements here except the reasons 

for conducting assessments and 

corrective actions, and discussed this 

at a public stakeholder meeting in 

April 2009. Assessments and 

corrective actions are the functional 

equivalent of the number of MCL

violations. The total number of 

positive e. coli samples replaces the 

existing requirement to report number 

of fecal coliform positives. The 

majority of commenters supported the 

changes in CCR requirements, 

especially the deletion of number of 

TC positives

After further reflection, I withdraw 

my objection to everything except the 

reasons for conducting assessments. 

Reporting on the number of 

assessments can be presented in a 

positive way by the system without 

alarming the public. However, if the 

system is required to report the trigger 

this may cause the public to think 

there is a public health concern where 

there is not. Since you did not 

propose this, there is no reason why 

you need to include it in the final rule. 

Reporting on the reason for corrective ...
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process that, where necessary, will require the PWS to correct sanitary defects. EPA believes it 

is most appropriate to inform the public about actions taken, in the form of assessments and 

corrective actions, since failure to conduct these activities lead to treatment technique violations 

under the RTCR. Because the RTCR no longer includes the total coliform MCL but now 

includes a trigger, EPA believes that systems no longer need to report the number of total 

coliform-positive samples via the CCR, since that could cause confusion or inappropriate 

changes in behavior among consumers. In addition, the CCR requirements will also reflect the 

removal of fecal coliform.

2. Key issues raised

In general, EPA received comments in support of the PN requirements of the RTCR. The 

commenters stated that the changes are consistent with the intent and recommendations of the 

TCRDSAC. However, there were a few commenters who disagreed on certain aspects of the 

requirements. These comments are discussed in detail in the following paragraphs.

EPA requested comment on whether the elimination of the PN associated with the presence 

of total coliforms (i.e., the Tier 2 PN associated with the non-acute MCL violation under the 

1989 TCR) will result in a loss of information to consumers. Although the majority of the 

commenters said that it would not result in a loss of information, some commenters said that it 

would. One commenter said that the PN associated with the presence of total coliforms has been 

an effective tool to motivate PWSs to take corrective actions; to eliminate such PN and replace it 

with a PN associated with treatment technique violations is not “equal to or better” public health 

protection. One commenter believed that if the non-acute PN requirement is eliminated, then 

NCWSs would not have the tool to communicate to the public the possible health risk as these 

PWSs are not required to send out a CCR.

Comment [JL93]: Any comments on 

the CCR requirements? You don’t 

discuss below.

Comment [EPA94]: We added text to 

the last paragraph of this section, on 

page 96.
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As EPA discussed in section III.B of this preamble, Rule Construct: MCLG and MCL for E. 

coli and Coliform Treatment Technique, the presence of total coliforms is not, by itself, a public 

health threat. EPA agrees with comments received that suggest that the Tier 2 PN for a nonacute MCL violation under the 1989 TCR is sometimes unnecessarily alarming as it attributes 

greater public health significance to the presence of total coliforms than is warranted. EPA 

believes the removal of the Tier 2 PN for a non-acute MCL violation will help prevent public 

confusion. 

EPA received comments that under the 1989 TCR some States require a Tier 1 PN when a 

NCWS has a non-acute MCL violation. EPA would like to note that the 1989 TCR requires a 

Tier 2 PN for a non-acute MCL violation, not a Tier 1 PN. Some States using their own 

authority have chosen to elevate the PN level to a Tier 1 for a non-acute MCL in some or all 

cases. In certain circumstances, some States use this elevated PN in association with other 

follow-up actions involving agreements with other State and local agencies, to provide a more 

comprehensive and immediate response to potential public health threats, or to make the most 

efficient use of their existing authorities to protect public health. It is not EPA’s intent to take

this discretion away from the States, or to undermine these cooperative agreements with other 

State and local agencies. If a State deems that a given situation calls for a more elevated level of 

PN, or requires a more immediate action to ensure that public health is protected, then they can 

do so under their own discretion and authority. For example, the Level 2 assessment 

requirements in § 141.859(b)(4) allow States to require expedited actions or additional actions to 

ensure that public health is protected.

EPA notes that NCWSs are required, like CWSs, to publish a PN, either a Tier 1, Tier 2, or 

Tier 3, depending on the violation. Even if they are not required to issue a CCR, NCWS must 
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provide PN in other forms or methods consistent with the requirements of 40 CFR 141.153. 

States can also direct the PWS to perform additional public health measures (e.g., boil water 

orders, elevated PNs, etc.) as allowed under SDWA and the authority granted to them by their 

own legislation similar to EPA’s authority under section 1431 of SDWA.

EPA requested comment on whether to require special notice to the public of sanitary defects 

similar to the special notice requirements for significant deficiencies under the GWR. Most 

commenters were against including such provision. They stated that it would cause confusion 

and unnecessary alarm to customers. Several commenters noted that it is not appropriate for 

sanitary defects under the RTCR to have similar notice requirements as that of significant 

deficiencies under the GWR. The special notice requirement for significant deficiencies under 

the GWR only applies to NCWSs since they are not required to send out a CCR. EPA agrees 

that no special notice of sanitary defects is necessary and is not including such provision in the 

RTCR.

EPA received comments suggesting modifications to the standard PN and CCR health effects 

language regarding total coliforms and the treatment technique violations included in the 

proposed RTCR. EPA has modified the standard health effects language found in Subpart O and 

Subpart Q of part 141 to make the language consistent with the use of total coliforms in the 

RTCR as an indicator of a potential pathway through which a contamination can enter the 

distribution system.

H. Reporting and Recordkeeping

1. Requirements

a. Reporting. In addition to the existing general reporting requirements provided in 40 CFR 

141.31, the RTCR requires a PWS to:

Comment [EPA95]: See JL comment 

above; standard health effects 

language for subpart O pertains to 

CCR.
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• Notify the State no later than the end of the next business day after it learns of an E. colipositive sample.

• Report an E. coli MCL violation to the State no later than the end of the next business day 

after learning of the violation. The PWS must also notify the public in accordance with 40 

CFR part 141 subpart Q. 

• Report a treatment technique violation to the State no later than the end of the next business 

day after it learns of the violation. The PWS must also notify the public in accordance with 

40 CFR part 141 subpart Q.

• Report monitoring violations to the State within ten days after the system discovers the 

violation, and notify the public in accordance with 40 CFR part 141 subpart Q. 

• Submit completed assessment form to the State within 30 days after determination that the 

coliform treatment technique trigger has been exceeded.

• Notify the State when each scheduled corrective action is completed for corrections not 

completed by the time of the submission of the assessment form.

• A seasonal system must certify that it has completed a State-approved start-up procedure 

prior to serving water to the public.

EPA is adding the submission of the assessment form and the certification of completion of 

start-up procedure to the reporting requirements under § 141.861 of the RTCR for better clarity 

and ease of tracking compliance. In the proposed rule, the submission of the assessment form is 

found only in § 141.859, Coliform treatment technique requirements for protection against 

potential fecal contamination. The inclusion of the submission of the assessment form in § 

141.861 does not impose additional requirements beyond those that are imposed by the treatment 

technique requirements (see section III.E of this preamble, Coliform Treatment Technique, for 
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discussion on the treatment technique requirements). Failure to submit the assessment form or 

the certification is a reporting violation as discussed in section III.F.1.d of this preamble, 

Reporting violation.

b. Recordkeeping. EPA is maintaining the requirements regarding the retention of sample 

results and records of decisions related to monitoring schedules found in 40 CFR 141.33, and 

including provisions that address the new requirements of the RTCR pertaining to reduced and 

increased monitoring, treatment technique, etc. In addition, systems are required to maintain on 

file for State review the assessment form or other available summary documentation of the 

sanitary defects and corrective actions taken. Systems are required to maintain these documents 

for a period not less than five years after completion of the assessment or corrective action. 

Since systems have to maintain these files no less than five years, which is the maximum period 

allowed between sanitary surveys (i.e., five years; see 40 CFR 142.16(b)(3) and 40 CFR 

142.16(o)(2)), States have the opportunity to review these files during sanitary surveys and/or 

annual visits. The five-year period is also consistent with the recordkeeping requirements for 

microbiological analyses under 40 CFR 141.33(a).

The system must also maintain a record of any repeat sample taken that meets State criteria 

for an extension of the 24-hour period for collecting repeat samples.

2. Key issues raised

EPA received comments that support the reporting and recordkeeping requirements proposed 

by EPA. Most commenters said that the timeframes are appropriate and are consistent with 

EPA’s practice regarding reporting and recordkeeping requirements in other regulations under 

SDWA. One commenter, however, said that EPA should standardize the recordkeeping 

requirements in all its rules, including the RTCR, for a period equal to the compliance cycle (i.e., 

Comment [JL96]: Was the seasonal 

start-up certification requirement in 

the AIP? Was it proposed?

Comment [EPA97]: AIP language, 

top of page 14: “The TCRDSAC 

recommends that all seasonal systems, 

on and after the compliance effective 

date, must demonstrate completion of 

a primacy agency approved start up 

procedure.” Also was in proposal.

See similar comments on p. 62, 92. 

JL withdrew comment on 7/25
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nine years). The commenter adds that by standardization and being consistent with the 

compliance cycle, all monitoring and compliance records including corrective actions will be 

easily maintained, tracked, and available for State's inspections without the confusion of varying 

recordkeeping durations with different regulations. However, EPA’s suite of drinking water 

regulations addresses different kinds of contaminants with different inherent characteristics, 

occurrence, and health effects. Because of these differences, monitoring of these contaminants 

occurs at different frequencies; hence, different reporting and recordkeeping requirements. The 

reporting and recordkeeping requirements specific to a drinking water regulation are therefore 

meant to support the implementation of that regulation. If possible, EPA makes every effort to 

ensure consistency of requirements across the drinking water regulations.

I. Analytical Methods

1. AIP-related method issues

a. Evaluation of currently approved methods. The AIP recommended that the Agency 

conduct a reevaluation of all the approved methods to ensure continued approval was warranted. 

In the proposed rule, the Agency identified the Environmental Technology Verification (ETV) 

program as the preferred mechanism for conducting such an evaluation and solicited comments 

on the approach.

Key issues raised. While several commenters expressed support for a method reevaluation

study conducted through the ETV program, some commenters expressed concern regarding the 

use of this program. One commenter stated that the reevaluation study should meet criteria 

established by EPA, not an EPA-contractor, who would receive financial benefit from the 

method manufacturers for conducting the testing. This commenter further expressed concern 

with using the ETV program because “the intent of the ETV program was never to certify, 
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approve, guarantee, or warrantee analytical technologies.” This commenter also suggested that 

the ETV program does not have the resources to develop the protocol for the method reevaluation study.

A second commenter expressed concern that the ETV program was established to facilitate 

incorporation of commercially-ready test kits into the market, which differs from the task of 

determining what are appropriate performance criteria for SDWA compliance methods. This 

commenter also expressed concern that the ETV program has not generated rigorous enough 

product evaluations adequate to support approval of alternative analytical procedures. 

Lastly, this commenter also suggested that the ETV studies do not have the same level of 

independence in protocol development as other third party studies, stating that in ETV studies,

reviewers modify the protocol at the beginning of each study, and that for the recent verification 

study, there was not a clear discussion between the study organizers and the technical review 

panel regarding development of the final test protocol. 

EPA will take the comments concerning the ETV program into consideration as the Agency 

develops a final approach to the reevaluation of methods. EPA notes that ETV work is 

accomplished through cooperative agreements between EPA and private non-profit testing and 

evaluation organizations. ETV partners verify performance claims but do not endorse, certify or 

approve technologies. EPA has the regulatory authority and the responsibility to 

approve/disapprove methods and typically does so based on a review of method performance 

data generated by third party laboratories. Testing under the ETV program is typically paid for 

by participating vendors.

ETV expert panels typically include representatives from industry, academia, EPA, and other 

stakeholders and collaborators. The rigor of an ETV study is determined by the objectives of the 
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study and the resources available. If such a study is conducted, EPA, by virtue of participation in 

the expert panel, would ensure that the study is rigorous enough to meet the Agency’s needs.

EPA held a series of three open technical webinars in fall 2010. Participants recommended 

the development of a coliform strain library. The Water Research Foundation (WRF) has funded 

a project to accomplish this task and the Agency will be monitoring the progress of that work as 

it considers the appropriate course of action.

b. Review of the ATP protocol. The AIP recommended that the Agency engage 

stakeholders in a technical dialogue in its review of the Alternate Test Procedure (ATP) 

microbiological protocol. The proposed rule described how EPA could use the study plan 

development from the aforementioned method reevaluation study as a starting point for 

discussions with stakeholders regarding the basis for evaluating new methods. The proposed 

rule also explained that the study plan, along with “lessons learned” from the reevaluation study, 

could be used as a model for a revised ATP protocol.

Key issues raised. One commenter suggested that the protocol used in the method 

reevaluation study should be used as the revised ATP protocol. EPA intends to consider this 

recommendation as it decides how to move forward on revising the microbial test protocol.

c. Approval of “24-hour” methods. The AIP recommended that EPA consider the approval 

of analytical methods that allow more timely (e.g., on the order of 24 hours) results. As 

expressed in the rule proposal, EPA has concern that the more rapid “24-hour” methods may not 

have the same recovery rates, especially for stressed or injured organisms, as the historic 

methods that allow for longer incubation times.
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Key issues raised. One commenter suggested that the Agency withdraw approval for the 

older approved methods that can require longer times to obtain results. EPA intends to consider 

this recommendation as it decides how to move forward.

d. Elimination of fecal coliforms. As explained in the rule proposal, EPA plans to eliminate 

all provisions for fecal coliform monitoring under this regulation. No comments were received 

on this issue. As such, all provisions relating to fecal coliforms are removed in this final rule.

e. Request for comment on other AIP-related method issues. i. Expedited results 

notification process. The proposed rule requested comment on whether the RTCR should 

include provisions to ensure a more expedited notification process. The RTCR could, for 

example, include language requiring that PWSs arrange to be notified of a positive result by their 

laboratory within 24 hours.

Key issues raised. The Agency received many comments regarding this element of the 

proposed rule. Many commenters expressed support for this provision, with some States 

reporting that this provision is an existing component of their State regulations. Several 

commenters expressed that given the widespread availability of electronic communication it 

would be easy for a laboratory to notify the public water system quickly of the results of the 

sample analyses.

Many comments expressed concern over the ability of the States to enforce such a provision. 

Additionally, several commenters noted that this provision would hold the water system 

accountable for the actions of the laboratory, which the public water system does not have 

immediate control over.

EPA believes that the public is well served by timely reporting of results but recognizes some 

of the challenges associated with addressing this via regulation. Accordingly, the Agency 
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intends to use guidance documents associated with this regulation to address this issue. Through 

the guidance documents, the Agency expects to urge public water systems to establish language 

in their contract with the laboratories requiring that the water system be notified by the 

laboratory within 24 hours of any positive results.

Additionally, the Agency plans to encourage the certified laboratory community to ensure 

that laboratories are aware of the importance of timely notification of any positive results to their 

clients.

ii. Taking repeat samples within 24 hours. During the Advisory Committee meetings, the 

factors impacting the timeframe between a coliform detection and the collection of the repeat 

sample were discussed. It was noted that in some cases, repeat samples are not collected for 

several days after notification of a coliform detection. EPA requested comment in the proposed 

rule whether the RTCR should require repeat samples be taken within 24 hours of a total 

coliform-positive with no (or limited) exceptions.

Key issues raised. While some commenters expressed support for such a provision in the 

final rule, most commenters noted that the final RTCR should retain flexibility around this 

requirement, as allowed in the 1989 TCR.

Several commenters noted that including such a provision in the final RTCR would create a 

hardship on systems, with many mentioning that weekend sample collection is a challenge for 

many small systems. Concern was expressed that this provision in the final rule would result in 

more monitoring violations but not necessarily change repeat sample collection practice.

Based on consideration of the concerns expressed, EPA is not changing the provision that

States may extend the 24-hour limit if the system has a logistical problem in collecting the repeat 
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samples within 24 hours that is beyond its control. See sections III.D of this preamble, Repeat 

Samples, for additional discussion.

2. Other method issues 

a. Holding time. In the proposed rule, EPA clarified the language defining when the sample 

holding time ends. The 1989 TCR states “the time from sample collection to initiation of 

analysis may not exceed 30 hours,” and this language was clarified in the proposed rule to state 

“The time from sample collection to initiation of test medium incubation may not exceed 30 

hours.”

Key issues raised. Two comments were received on this rule provision, with one commenter 

explaining that some water systems have a difficult time meeting the 30-hour hold time, and this 

provision may further impact their ability to meet the holding time. The second commenter 

stated that the number of coliforms does not likely change in “a 30 minute window” and that this 

provision will not improve public health.

As explained in the proposed rule, EPA recognizes that this provision may slightly decrease 

the amount of time that a water system has to get the sample to the lab, by approximately 30 

minutes or less. EPA believes the impact of this provision is minimal, as a well managed 

laboratory will be able to recognize a sample that is received near the end of the holding time and 

make this sample a priority for analysis.

The inclusion of this provision in the final rule serves to ensure consistency in the analyses of 

the compliance samples on a national basis and will have a minimal impact on water systems. 

As such, the provision is included in the final rule.

b. Dechlorinating agent. The proposed rule included a provision that would require the use 

of a dechlorinating agent when samples of chlorinated water are collected.
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Key issues raised. The Agency did not receive any adverse comment to this provision of the 

proposed regulation. Accordingly, this provision has been included in the final rule. EPA notes 

that the wording of this provision in the final rule differs slightly from that included in the 

proposed rule. The wording was changed to clarify that the use of a dechlorinating agent is 

applicable to water systems that use any type of chlorination (including chloramines) to disinfect 

their drinking water supplies. The proposed rule did not include language that was specific 

enough to ensure that this point was clear.

c. Filtration funnels. In the proposed rule, EPA added a footnote to the methods table that 

clarifies that the funnels used in the membrane filtration procedure should be sterilized by 

autoclaving, not by using ultraviolet (UV) light. The addition of this provision to the rule makes 

the rule requirements consistent with what is recommended by the Agency in the Manual for the 

Certification of Laboratories Analyzing Drinking Water (EPA 815-R-05-004, 5th Edition, 2005).

Key issues raised. The Agency only received one comment on this provision, requesting 

clarification that would allow the use of disposable filtration units that are purchased presterilized by the manufacturer. EPA believes that these units can be appropriate for use in 

drinking water sample analyses, and therefore has modified the provision to reflect usage of such 

units. The provision now reads as follows:

All filtration series must begin with membrane filtration equipment that has been 

sterilized by autoclaving. Exposure of filtration equipment to UV light is not adequate to 

ensure sterilization. Subsequent to the initial autoclaving, exposure of the filtration 

equipment to UV light may be used to sanitize the funnels between filtrations within a 

filtration series. Alternatively, disposable membrane filtration equipment that is presterilized by the manufacturer (i.e., disposable funnel units) may be used.

d. Analytical methods table changes. The proposed rule reflected many modifications to the 

table of analytical methods to clarify which methods were approved for use under this regulation.
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No comments were received on the following changes to the methods table. Accordingly 

these modifications have been incorporated into the final rule.

• The table is organized by methodology.

• E. coli methods are included in the analytical methods table.

• The 18th and 19th editions of Standard Methods for the Examination of Water and 

Wastewater are no longer approved and are not included in the final rule.

• The references to Standard Methods 9221A and 9222A are removed.

• The reference to Standard Methods 9221B is changed to 9221B.1, B.2.

• The reference to Standard Methods 9221D is changed to 9221D.1, D.2.

• The citation for MI agar is changed to EPA Method 1604.

• The table clarifies that Standard Methods 9221 F.1 and 9222 G.1c(1), and 9222 G.1c(2) may 

be used for E. coli analysis.

• The table clarifies the correct formulation for E. coli (EC) medium with 4-

methylumbelliferyl-Beta-D-glucuronide (EC-MUG) broth, or EC–-MUG broth, when used in 

conjunction with Standard Methods 9222G.1c(2), through the addition of the following 

footnote: The following changes must be made to the EC broth with MUG (EC–-MUG) 

formulation: Potassium dihydrogen phosphate, KH2PO4 must be 1.5g and 4-

methylumbelliferyl-Beta-D-glucuronide must be 0.05 g.

• The table reflects the approval of a modified Colitag method for the simultaneous detection 

of E. coli and other total coliforms.

The proposed rule also contained a provision to allow the use of Standard Methods 9221D in 

an enumerative format, specifically, in the multiple tube format as described in Standard 

Methods 9221B.
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Key issues raised. One comment was received, stating that the use of Standard Methods 

9221D in an enumerative (multiple tube) format should be evaluated through an Alternate Test 

Procedure (ATP) study or be added to the proposed method reevaluation study. Given that this 

method is a part of Standard Methods 9221, entitled “Multiple-Tube Fermentation Technique for 

Members of the Coliform Group,” the Agency believes it is appropriate for this method to be 

used in an enumerative, multiple tube format. Additionally, as explained in the proposed rule, 

there have been publications demonstrating that this method is effective in a multiple tube 

format.

Since use of this method in a multiple-tube format does not change the formulation of the 

medium, nor the volume of sample analyzed, the Agency has determined that an ATP evaluation 

is not necessary. Therefore, the provision is included in the final rule.

e. Holding temperature. In the proposed rule, the Agency requested comment as to whether 

the RTCR should require the samples to be held at 10 degrees Celsius (C) or less during transit.

Key issues raised. Several commenters expressed support for this provision stating that it 

would improve the integrity of the data collected under this rule. However, many commenters 

expressed concern that the addition of this provision would cause a hardship, especially to small 

systems, as it would increase the cost of the sample shipment. Additionally, concern was 

expressed that this provision would increase the number of “failure to monitor” violations, 

thereby imposing an enforcement burden on the States.

Based on further consideration of the potential additional burden on both the public water 

systemPWSs and the States, EPA has determined that the provision in the 1989 TCR will stay as 

is: “Systems are encouraged but not required to hold samples below 10 deg. C during transit.”
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Finally, in this final rule, there have been some further changes to the analytical methods 

table to improve its clarity. Such changes include the addition of the approved online versions of 

Standard Methods in the analytical methods table and correction of some clerical errors.

J. Systems Under EPA Direct Implementation

Systems falling under direct oversight of EPA (e.g., Tribal systems, PWSs in Wyoming, and 

PWSs in States that have not yet obtained primacy for the RTCR) where EPA acts as the State, 

must comply with decisions made by EPA for implementation of the RTCR. Under § 142.16(q), 

to obtain primacy for the RTCR, States/Tribes are required to demonstrate how they intend to 

implement the various requirements of the rule; States/Tribes may do so in a manner that 

maximizes the efficiency of the rule for the States/Tribes and the PWSs while maintaining or 

increasing the effectiveness of the rule to protect public health. EPA has the same 

responsibilities when the Agency acts as the State when it oversees in directly implementation 

entities implementing the RTCR. In the proposed RTCR, EPA requested comment on whether 

to make this explicit in the final RTCR. All commenters who responded to this request for 

comment were in support of such action. EPA already has such authority or flexibility in direct 

implementation situations, both in the 1989 TCR and in all other NPDWRs, but solicited 

comment and has added this provision to the final rule for the sake of clarity in situations where 

EPA directly implements the RTCR.

K. Compliance Date

Consistent with SDWA section 1412(b)(10), States and PWSs are given three years after the 

promulgation of the RTCR to prepare for compliance with the rule. PWSs must begin 

compliance with the requirements of the RTCR on [INSERT DATE THREE YEARS AFTER

PUBLICATION IN THE FEDERAL REGISTER] April 1, 2016, a compliance effective date 

Comment [EPA98]: Added 

maintaining in response to Jim’s 

comment below

Comment [JL99]: Maintaining?
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that is just over three years from promulgation and coincides with quarterly monitoring 

schedules applicable to many water systems. EPA believes that capital improvements generally 

are not necessary to ensure compliance with the RTCR. However, a State may allow individual 

systems up to two additional years to comply with the RTCR if the State determines that 

additional time is necessary for capital improvements, in accordance with SDWA section 

1412(b)(10).

IV. Other Elements of the Revised Total Coliform Rule

A. Best Available Technology

1. Requirements

EPA is making three modifications to the 1989 TCR provisions regarding the best 

technology, treatment techniques, or other means available for achieving compliance with the 

MCL for E. coli under the RTCR. EPA has re-designated these provisions from 40 CFR

141.63(d) to 141.63(e) and is making the following modifications.

• “Coliforms” in 40 CFR 141.63(d)(1) under the 1989 TCR is replaced with “fecal 

contaminants” in 40 CFR 141.63(e)(1).

• “Cross connection control” is added to the list of proper maintenance practices for the

distribution system in 40 CFR 141.63(e)(3) (formerly 40 CFR 141.63(d)(3)).

• Subparts P, T, and W (filtration and/or disinfection of surface water), and subpart S 

(disinfection of ground water), are added in 40 CFR 141.63(e)(4) (formerly 40 CFR 

141.63(d)(4)). 

The Agency is listing the same technology, treatment techniques, or other means available 

for achieving compliance with the MCL for E. coli as provided in § 141.63(e), for small public 

Comment [JL100]: What is the 

practical import of these changes?

Comment [EPA101]: Little practical 

import, this is mostly bookkeeping.

- Replaced “coliforms” with “fecal 

contaminants” because of the change 

in the meaning of the indicators. 

- Cross connection control added 

because it is a criterion for reduced 

monitoring. 

- BAT added for microbial rules 

promulgated since the SWTR. 
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water systemPWSs serving 10,000 or fewer people, as required by SDWA section 

1412(b)(4)(E)(ii).

2. Key issues raised

EPA received comments that supported the modifications to the list of best available 

technologies (BATs). The Agency also received comments suggesting the addition of other 

items to the list, such as the optional barriers that may qualify systems for reduced monitoring, 

unidirectional flushing, storage tank inspection, maintenance, and cleaning, and repressurization. EPA heard from a few commenters who are against the inclusion of cross 

connection control in the list of BATs. They stated that it is not appropriate to do so because 

EPA has not defined cross connection control, and risks associated with cross connection and 

backflow are being addressed in the research efforts of the Research and Information Collection 

Partnership (RICP) (see 

http://water.epa.gov/lawsregs/rulesregs/sdwa/tcr/regulation_revisions_tcrdsac.cfm#ricp for 

additional information about the Partnership); hence, they concluded it is premature to include it 

in the RTCR.

The methods for achieving compliance listed in 40 CFR 141.63(e) represent the technology, 

treatment technique, and other means which EPA finds to be feasible for purposes of meeting the 

MCL for E. coli, in accordance with section 1412(b)(4)(E) of SDWA. The RTCR however, is 

not imposing additional requirements (e.g., disinfection, filtration, etc.) beyond those already 

addressed by other microbial drinking water regulations such as the Ground Water Rule and the 

Surface Water Treatment Rules; nor is it imposing specific requirements regarding the use of the 

other methods such as main flushing programs, cross connection control, etc. PWSs are given 

the discretion to use the methods in 40 CFR 141.63(e) (if they are not already required to do so), 
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or other methods of their choice (provided they are acceptable to the State), as they see fit for 

their own systems. 

EPA believes that the inclusion of cross connection control to the list of BATs is appropriate 

given the public health risk associated with unprotected cross connection. Several States already 

require that PWSs implement a cross connection control program. As discussed in the previous 

paragraph, the inclusion of cross connection control in 40 CFR 141.63(e) does not impose 

specific requirements on PWSs regarding to implementing a cross connection control program. 

Rather, it acknowledges that cross connection control can be one of the tools PWSs can use to 

comply with the E. coli MCL.

B. Variances and Exemptions

1. Requirements

EPA is not allowing variances or exemptions to the E. coli MCL in § 141.4(a). EPA believes 

that water that exceeds the MCL for E. coli poses an unreasonable risk to public health. 

Therefore, EPA is not allowing any variances or exemptions to the E. coli MCL. EPA is also 

eliminating the variance provisions in § 141.4(b) under the 1989 TCR that allow systems to 

demonstrate to the State that the violation of the monthly/non-acute total coliform MCL is due to 

biofilm and not fecal or pathogenic contamination. This change also results in a parallel change 

in § 142.63(b). Since the MCL for total coliforms is eliminated and replaced by a treatment 

technique, the variance for the presence of biofilms is no longer applicable and allowed under 

SDWA. Instead, the presence of biofilm is addressed through the assessment and corrective 

action requirements of the RTCR.

EPA is adding a note to the provision in § 141.4(a) to specify clarify that small system 

variances or exemptions for treatment technique requirements in this rule and other rules that 

Comment [EPA102]: Clarification 

that it is not allowed under SDWA. 

OGC directed the exact language.
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control microbial contaminants may not be granted under SDWA section 1415(e)(6)(B) and § 

142.304(a). This action reflects the statutory provision within EPA’s regulations and adds no 

new requirements or limitations to any of these rules.

2. Key issues raised

Most commenters support these changes. However, EPA also received comment that 

supported the retention of the variance for the presence of biofilms. The commenter said that the 

retention of the biofilm variance would require PWSs to have a biofilm control program in place 

that will require ongoing assessment and research to determine and address the cause of the 

biofilms, thereby providing valuable information. Some commenters suggested that if the 

biofilm variance is removed, EPA should make it clear that the finding of biofilms as the cause 

of the positive sample during an assessment is not a sanitary defect which requires correction. 

As discussed previously in section IV.B.1 of this preamble, Requirements, EPA is not 

allowing variances to the E. coli MCL because EPA believes that water which exceeds the MCL 

for E. coli poses an unreasonable risk to public health. Furthermore, retention of the variance for 

total coliforms is not allowed under SDWA because the MCL for total coliforms is eliminated 

and replaced by a treatment technique. EPA believes that additional research and information 

collection will be valuable to learning about the magnitude of the risks from biofilms. However, 

research available to date indicates that biofilms can harbor pathogens and result in accumulation 

of contaminants (Brown and Barker 1999; Szewzyk et al. 2000; Berry et al. 2006; Långmark et 

al. 2007), and considering it a sanitary defect is warranted in some cases. Also, persistent 

biofilms that cause continued total coliform presence compromises the value of total coliforms as 

an indicator of potential pathways of contamination. If biofilm is determined to be the cause of 

the total coliform-positive samples that triggered an assessment, the PWS is encouraged to work 

Comment [JL103]: Why do you need 

to add this?
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with the State to determine the right course of action to address the biofilms. Under the RTCR, 

States have the discretion to determine if the completed assessment and corrective action are 

adequate. The State can use this discretion in addressing instances of biofilm presence and 

determining the extent of biofilm problems in the distribution system and the need to address 

them. When a system has an ongoing biofilm problem that continues to cause total coliformpositive samples, the system and the State can continue to take action until the biofilm problem 

is resolved. 

C. Revisions to Other NPDWRs as a Result of the RTCR

EPA recognizes that there are linkages among monitoring requirements between the 1989 

TCR and other NPDWRs. For instance, under the Surface Water Treatment Rule (SWTR) 

(USEPA 1989b, 54 FR 27486, June 29, 1989) and the Stage 1 Disinfectants and Disinfection 

Byproducts Rule (Stage 1 DBPR) (USEPA 1998a, 63 FR 69389, December 16, 1998), the 

residual disinfectant monitoring must be conducted at the same time and location at which total 

coliform samples are taken, as required. Under the SWTR, high measurements of turbidity in an 

unfiltered subpart H system (i.e., a system using surface water or ground water under the 

influence of surface water) trigger additional total coliform samples; and compliance with the 

total coliform MCL under the 1989 TCR is one of the criteria for a PWS to avoid filtration. 

Under the GWR, 1989 TCR distribution system monitoring results determine whether a system 

is required to conduct source water monitoring. 

For the criteria for avoiding filtration in the SWTR (§ 141.71(b)(5)), the Agency is clarifying 

that unfiltered systems must continue to meet the E. coli MCL promulgated with the final RTCR

at § 141.63(c) in order to remain unfiltered. The changes to § 141.71(b)(5) provides for 

replacement of the (acute) total coliform MCL at § 141.63(b) with the E. coli MCL at § 
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141.63(c) at the compliance date of the RTCR. Although the name of the MCL has changed, the 

determination of the E. coli MCL remains basically the same as that for the (acute) total coliform 

MCL in § 141.63(c), with the only changes being those that were made to address the advisory 

committee recommendations and the public comments.

After considering other possible linkages between the RTCR and the SWTR, GWR, Stage 1 

DBPR, Stage 2 DBPR (USEPA 2006e, 71 FR 388, January 4, 2006), and Airline Drinking Water 

Rule (ADWR) (USEPA 2009), EPA has concluded that the only other necessary revision to 

these NPDWRs is to update the references to the 1989 TCR at 40 CFR 141.21, which is 

superseded by 40 CFR part 141 subpart Y beginning April 1, 2016[INSERT DATE THREE 

YEARS AFTER PUBLICATION IN THE FEDERAL REGISTER]. The monitoring 

requirements themselves are not changing as a result of the RTCR. Residual disinfectant 

samples must still be taken at the same time and location at which total coliform samples are 

taken under the RTCR. High measurements of turbidity under the SWTR would still result in 

additional total coliform samples. Results of total coliform monitoring under the RTCR would 

still be a trigger for the GWR. Although there are changes to the dual-purpose sampling 

requirement (i.e., one sample to satisfy both the repeat monitoring requirement of the RTCR and 

the triggered source water monitoring requirement of the GWR), these changes are addressed in 

the RTCR and not in the GWR (see section III.D of this preamble, Repeat Samples, for further 

discussion on dual-purpose sampling). Comments received on dual-purpose sampling are also 

discussed in section III.D of this preamble, Repeat Samples.

EPA also received comments regarding the relationship between source water evaluations 

under the GWR and assessments under RTCR; those comments are addressed in section III.E.2 

of this preamble, Assessment. 
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The RTCR is also not changing the existing sanitary survey requirements established under 

the IESWTR and the GWR. However, the RTCR is adding the special monitoring evaluation 

that States must conduct at systems serving 1,000 or fewer people during the sanitary survey. 

These evaluations are not expected to significantly increase the burden to conduct sanitary 

surveys because of the relatively simple nature of these systems and their monitoring 

requirements.

EPA did not receive any other substantial comments regarding the relationships between 

RTCR and other NPDWRs.

EPA recognizes that there are sections of part 141 that will no longer be applicable after the 

RTCR compliance effective date. EPA intends to review and update these sections in the future.

D. Storage Facility Inspection

In the proposed RTCR, EPA discussed the potential public health implications associated 

with poorly maintained storage facilities (such as those associated with significant sediment 

accumulation inside the tank and the presence of breaches). EPA requested comment and 

supporting information regarding the current status of storage tanks and their inspection as 

implemented by individual States and PWSs. Some of the information EPA requested comment 

on included the state and condition of tanks that have been cleaned and inspected, costs of 

storage tank inspection and cleaning, the frequency of inspection and cleaning, and how public 

health can be better protected. Based on the comments and information that EPA received, the 

Agency is proposing considering the need for inspection requirements for finished water storage 

facilities that will would help mitigate potential the public health risks associated when if public 

water systemPWSs do not inspect their storage facilities as recommended by industry guidance

(e.g., American Water Works Association (AWWA) Manual 42). EPA willplans to provide 

Comment [EPA104]: Added example 

guidance

Comment [EPA105]: Changed “will” 

to “plans to”
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further information on the results of its consideration of this issue in a future notice. The Agency 

is also requesting comments on specific aspects of inspection and cleaning of finished water 

storage facilities. The proposed requirements for storage facilities are published separately from 

the final RTCR in today’s Federal Register. 

V. State Implementation 

SDWA establishes requirements that States or eligible Indian Tribes must meet to assume 

and maintain primary enforcement responsibility (primacy) to implement national primary 

drinking water regulations. This section describes the requirements that States must meet to 

maintain primacy under the RTCR, including adoption of drinking water regulations that are no 

less stringent than the RTCR and meeting recordkeeping and reporting requirements. This 

section also provides an update on the Safe Drinking Water Information System (SDWIS) 

revisions that EPA is developing to facilitate the implementation of RTCR. 

A. Primacy

1. Requirements

States are required to adopt or maintain requirements that are at least as stringent as all of the 

sections of 41 CFR part 141that are revised or added by the RTCR. SDWA provides two years 

after promulgation of the RTCR (plus up to two more years if the Administrator approves) for 

the State to adopt their regulations. States may adopt more stringent requirements (e.g., 

requiring all systems to conduct routine monthly monitoring). Many States have used this 

authority in the past to improve public health protection and/or simplify implementation.

EPA grants interim primary enforcement authority for a new or revised regulation during the 

period in which EPA is making a determination with regard to primacy for that new or revised 

regulation. States that have primacy (including interim primacy) for every existing NPDWR 
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already in effect may obtain interim primacy for the RTCR, beginning on the date that the State 

submits the application for this rule to EPA, or the effective date of its revised regulations, 

whichever is later. A State that wishes to obtain interim primacy for future NPDWRs must 

obtain primacy for this rule.

EPA regulations at 40 CFR part 142 contain the program implementation requirements for 

States to obtain primacy for the public water supply supervision program as authorized under 

SDWA section 1413. In addition to adopting rule requirements that are at least as stringent as 

the requirements of the RTCR, and basic primacy requirements specified in 40 CFR part 142, 

States are required to adopt special primacy provisions pertaining to each specific regulation 

where State implementation of the rule involves activities beyond general primacy provisions. 

States must include these regulation-specific provisions in their application for approval of any 

program revision. States must also continue to meet all other conditions of primacy for all other 

rules in 40 CFR part 142. 

The RTCR provides States with flexibility to implement the requirements of the rule in a 

manner that maximizes the efficiency of the rule for the States and water systems while 

increasing the effectiveness of the rule to protect public health. To ensure an effective and 

enforceable program under the RTCR, the State primacy application for RTCR must include a 

description of how the State will meet the following special primacy provisions contained in the 

RTCR at 40 CFR part 142:

• Baseline and Reduced Monitoring Provisions – The State primacy application must indicate 

what baseline and reduced monitoring provisions of the RTCR the State will adopt and 

describe how the State will implement the RTCR in these areas so that EPA can be assured 

that implementation plans meet the minimum requirements of the rule.
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• Sample Siting Plans - States must describe the frequency and process used to review and 

revise sample siting plans in accordance with 40 CFR 141, subpart Y to determine adequacy. 

• Reduced Monitoring Criteria – The primacy application must indicate whether the State will 

adopt the reduced monitoring provisions of the RTCR (e.g., reduced monitoring provisions 

for GW ground water systems serving 1,000 or fewer people, including provisions on dual 

purpose sampling). If the State adopts the reduced monitoring provisions, it must describe 

the specific types or categories of water systems that will be covered by reduced monitoring 

and whether the State will use all or a reduced set of the optional criteria. For each of the 

reduced monitoring criteria, both mandatory and optional, the State must describe how the 

criteria will be evaluated to determine when systems qualify.

• Assessments and Corrective Actions – States must describe their process to implement the 

new assessment and corrective action phase of the rule. The description must include how

the State will ensure that Level 2 assessments are more comprehensive than Level 1 

assessments, examples of sanitary defects, examples of assessment forms or formats, and 

methods that systems may use to consult with the State on appropriate corrective actions.

• Invalidation of routine and repeat samples collected under the RTCR – States must describe 

their criteria and process to invalidate total coliform-positive and E. coli-positive samples 

under the RTCR. This includes criteria to determine if a sample was improperly processed 

by the laboratory, reflects a domestic or other non-distribution system plumbing problem or 

reflects circumstances or conditions that does not reflect water quality in the distribution 

system. 

• Approval of individuals allowed to conduct RTCR Level 2 assessments – States must 

describe their criteria and process for approval of individuals allowed to conduct RTCR Y 
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Level 2 assessments.

• Special monitoring evaluation – States must describe how they will perform special 

monitoring evaluations during sanitary surveys for ground water systems serving 1,000 or 

fewer people to determine whether systems are on an appropriate monitoring schedule.

• Seasonal systems – States must describe how they will identify seasonal systems, how they 

will determine when systems on less than monthly monitoring must monitor, and what will 

be the seasonal system start-up provisions.

• Additional criteria for reduced monitoring – States must describe how they will require 

systems on reduced monitoring to demonstrate, where appropriate:

- Continuous disinfection entering the distribution system and a residual in the distribution 

system.

- Cross connection control.

- Other enhancements to water system barriers.

• Criteria for extending the 24-hour period for collecting repeat samples – If the State elects to 

use a set of criteria in lieu of case-by-case decisions, they must describe the criteria they will 

use to waive the 24-hour time limit for collecting repeat samples after a total coliformpositive routine sample, or to extend the 24-hour limit for collection of samples following 

invalidation. If the State elects to use only case-by-case waivers, the State does not need to 

develop and submit criteria.

2. Key issues raised

Commenters generally supported the inclusion of these activities in the primacy application 

and emphasized the importance of the flexibility and discretion that this approach provides for 

States to build on existing authorities of the 1989 TCR and focus on systems with the greatest 

Comment [JL106]: Did any states 

object to the burden of providing all 

this documentation?

Comment [EPA107]: Some objected 

to specific elements as described in 

the sections that follow but none 

objected to the overall requirements.
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need. They suggested that EPA allow States as much flexibility and discretion as possible to 

design their approach to implementing the RTCR, including how to address seasonal water 

systems, second Level 1 assessments, qualifications of assessors, the content of sample siting 

plans, and compliance with multiple rules (e.g., coordination between 1989 TCR / RTCR and 

GWR compliance), and how to consider multiple Level 1 assessments where the cause of the 

first Level 1 assessment has been identified and corrected. However, some commenters 

suggested removal of some of the special primacy requirements, such as those regarding seasonal 

system startup procedures and how the States will review sample siting plans, implement the 

assessment and corrective action phase, and determine who is approved to conduct Level 2 

assessments. EPA is maintaining these primacy requirements in the RTCR because they provide 

the States with the flexibility to design their programs to fit their own needs without prescriptive, 

one-size-fits-all requirements. Describing how the State will accomplish them in the primacy 

application assures that consumers nationwide are receiving adequate and comparable public 

health protection under the rule. 

EPA also requested comment on whether it is appropriate to have States describe their 

criteria for waiving or extending the 24-hour limit to collect repeat samples as a special primacy

condition, or instead have States keep records of decisions to waive and/or extend the 24-hour 

limit. The majority of the commenters supported the former option as it reduces paperwork 

burden and adds flexibility to the implementation of the RTCR. EPA concurs and added the 

waiver or extension of the 24-hour limit to the special primacy requirements as an option for 

States that would rather describe their criteria for waiving or extending the 24-hour limit in their 

primacy application, instead of having to make the decision on a case-by-case basis. States that 

elect to use only case-by-case waivers do not need to develop and submit criteria.

Comment [JL108]: Not sure what 

this means.

Comment [EPA109]: Added “in a 

rolling 12 month period”, as stated 

above and in the AIP. Triggers a level 

2 assessment.

JL: Still not clear what the flexibility 

is here. If they trigger a second Level 

1 assessments in a rolling 12-month 

period (I interpret this to mean less 

than 12 months apart, regardless of 

calendar year), then a Level 2 

assessment is required. What is the 

flexibility, and what does the state 

need to describe in its primacy 

package?

EPA – let’s discuss. We are relaying 

comments received here. One 

suggested that we eliminate the 

automatic Level 2 assessment when 

the second Level 1 was triggered, and 

leave it up to the state to describe in 

their primacy package how they will 

handle them. Another supported our 

approach of allowing the state to not 

count the second level 1 toward a 

level 2 trigger if the cause has been 

identified and corrected 

Revision to this sentence agreed 

upon 7/26

Comment [JL110]: Who? States?

Comment [EPA111]: A few states 

made comments on the following 

specific requirements: Sample siting 

plans (OH, WA, PA) Assessments and 

Corrective Action (WA, PA) Seasonal 

startup procedures (PA). However, 

ASDWA suggested providing states 

with as much flex as possible: 

“Special primacy requirements match 

the recommendations in the AIP and 

provide a reasonable way for states to 

communicate with EPA and other 

parties about how specific aspects of 

the rule will be implemented. By 

including these elements in the ...
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B. State Recordkeeping and Reporting and SDWIS

1. Recordkeeping

The current regulations in 40 CFR 142.14 require States with primacy to keep records, 

including: analytical results to determine compliance with MCLs, maximum residual disinfectant 

levels (MRDLs), and treatment technique requirements; PWS inventories; State approvals; 

enforcement actions; and the issuance of variances and exemptions. Consistent with the 

recordkeeping requirements of the current regulations, the RTCR requires States to keep records 

and supporting information for each of the following decisions or activities for five years:

• Any case-by-case decision to waive the 24-hour time limit for collecting repeat samples after 

a total coliform-positive routine sample, or to extend the 24-hour limit for collection of 

samples following invalidation, or for an unfiltered subpart H system of this part to collect a 

total coliform sample following a turbidity measurement exceeding 1 nephelometric turbidity 

unit (NTU).

• Any decision to allow a system to waive the requirement for three routine samples the month 

following a total coliform-positive sample. The record of the waiver decision must contain 

all the items listed in §§ 141.854(j) and 141.855(f) of the RTCR.

• Any decision to invalidate a total coliform-positive sample. If the State decides to invalidate 

a total coliform-positive sample as provided in § 141.853(c)(1) of the RTCR, the record of 

the decision must contain all the items listed in that paragraph.

Also, consistent with the recordkeeping requirements of the current regulations, under the 

RTCR States must retain records of each of the following decisions in such a manner so that 

each system’s current status may be determined at any time:

Comment [JL112]: This is covered 

below.

Comment [EPA113]: ok
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• Any decision to reduce the total coliform monitoring frequency for a community water 

system serving 1,000 or fewer people to less than once per month, as provided in § 

141.855(d) of the RTCR; and what the reduced monitoring frequency is. A copy of the 

reduced monitoring frequency must be provided to the system.

• Any decision to reduce the total coliform monitoring frequency for a non-community water 

system using only ground water and serving 1,000 or fewer people to less than once per 

quarter, as provided in § 141.854(e) of the RTCR, and what the reduced monitoring 

frequency is. A copy of the reduced monitoring frequency must be provided to the system.

• Any decision to reduce the total coliform monitoring frequency for a non-community water 

system using only ground water and serving more than 1,000 persons during any month the 

system serves 1,000 or fewer people, as provided in § 141.857(d) of the RTCR. A copy of 

the reduced monitoring frequency must be provided to the system.

• Any decision to waive the 24-hour limit for taking a total coliform sample for a public water 

system that uses surface water, or ground water under the direct influence of surface water, 

and that does not practice filtration in accordance with part 141, subparts H, P, T, and W, and 

that measures a source water turbidity level exceeding 1 nephelometric turbidity unit (NTU)

near the first service connection.

• Any decision to allow a public water system to forgo E. coli testing on a total coliformpositive sample if that system assumes that the total coliform-positive sample is E. colipositive.

The RTCR also adds the following new recordkeeping requirement:

Comment [JL114]: Not clear why it 

is necessary to keep a record of this. 

As long as the sample is treated as ecoli positive, with all accompanying 

requirements, what does it matter for 

the future whether it was “really” ecoli positive or the system simply 

chose to treat it as such? Does 

treating it as such (without testing) 

confer any benefit on the system? If 

not, I don’t see the need to keep a 

record of this.

Comment [EPA115]: Carryover from 

existing TCR requirement – see 

142.14(a)(5)(ii)(G). Did not receive 

any comments.

JL: This does not seem like a good 

reason to keep an unnecessary 

requirement, probably nobody even 

noticed it. Is there any practical utility 

to keeping a record of this. What 

would anybody ever use it for? If not, 

suggest deleting.

EPA – AIP said to not change 

anything they did not address. 

Utility – need to keep a record of 

why response actions were taken if 

there was no positive E. coli?
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• States must keep records and supporting information regarding completed and approved 

RTCR assessments, including reports from the system that corrective action has been 

completed, for five years.

2. Reporting 

EPA currently requires at 40 CFR 142.15 that States report to EPA information such as 

violations, variance and exemption status, and enforcement actions. The RTCR requires States 

to develop and maintain a list of public water systems that the State is allowing to monitor less

frequently than once per month for community water systems or less frequently than once per 

quarter for non-community water systems, including the compliance date (the date that reduced 

monitoring was approved) of the reduced monitoring requirement for each system. 

3. SDWIS 

EPA has begun to plan and develop the next version of SDWIS, SDWIS Next Gen, which 

will provide improved capabilities to update the system when there are new rule requirements 

and that enables more efficient data sharing among systems, laboratories, States, and EPA. EPA 

has established a governance structure to allow States to provide input on SDWIS Next Gen and 

begin identifying and prioritizing necessary system functions. Developing the portions of the 

system that are needed for implementing RTCR is a high priority. EPA remains committed to 

completing revisions to SDWIS that will facilitate implementation of RTCR and to completing 

them well in advance of the effective date of the rule.

4. Key issues raised

Many commenters emphasized the importance of developing revisions to SDWIS sufficiently 

in advance of the effective date of the rule to allow for efficient, effective, and consistent 

implementation, tracking, recordkeeping, and reporting. As indicated above, EPA has already 
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begun planning and development of SDWIS Next Gen to incorporate changes necessary to 

implement RTCR. EPA plans to complete the revisions necessary to implement RTCR well in 

advance of the RTCR effective date. Commenters also noted the advisory committee 

recommendation to develop metrics for evaluating the effectiveness of RTCR. Identifying 

metrics and incorporating them into SDWIS Next Gen will be part of the process completed by 

the governance structure with the input of stakeholders.

Some commenters objected to the requirement for States to maintain lists of systems on 

reduced monitoring and information on decisions on sample invalidations and waivers of time 

limits. EPA notes that these requirements also existed under the 1989 TCR and are not new 

under the RTCR. These requirements, and the requirements to maintain other information such 

as regarding assessments and review of seasonal system startup procedures, will be considered in 

the design of SDWIS Next Gen and incorporated to the extent possible to help States efficiently 

manage their implementation requirements.

Commenters also expressed the need for guidance to help States implement rule requirements 

regarding annual site visits for systems on annual monitoring, review of system RTCR 

monitoring frequency during sanitary surveys, review of seasonal system startup procedures, and 

identification of qualified assessors for Level 2 assessments. EPA plans to work with States to 

develop the necessary changes in implementation guidance well before the effective date of the 

RTCR.

VI. Economic Analysis (Health Risk Reduction and Cost Analysis)

This section summarizes the economic analysis (EA) for the final RTCR. The EA is an 

assessment of the benefits, both health and non-health-related, and costs to the regulated 

community of the final regulation, along with those of regulatory alternatives that the Agency 

Comment [JL116]: Who? States?

Comment [EPA117]: Some states 

(WI,MN) and ASDWA but 

commenters noted that maintaining

the information in SDWIS, as we 

suggest in this paragraph, would be 

acceptable. Current section 

142.14(a)(4)(ii) already requires states 

to maintain records of case-by-case 

decisions.
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considered. EPA developed the EA for the RTCR to meet the requirement of SDWA section 

1412(b)(3)(C) for a Health Risk Reduction and Cost Analysis (HRRCA), as well as the 

requirements of Executive Order 12866, Regulatory Planning and Review, and Executive Order 

13563, Improving Regulation and Regulatory Review, under which EPA must estimate the costs 

and benefits of the rule. The full EA for the final RTCR (RTCR EA) (USEPA 2012a) includes 

additional details and discussion on the topics presented throughout this section of the preamble. 

It is available in the docket (Docket ID No. EPA-HQ-OW-2008-0878) and is also published on 

the government’s Web site at http://www.regulations.gov. 

SDWA section 1412(b)(3)(C) requires that the HRRCA for a NPDWR take into account the 

following seven elements: (1) quantifiable and nonquantifiable health risk reduction benefits; (2) 

quantifiable and nonquantifiable health risk reduction benefits from reductions in co-occurring 

contaminants; (3) quantifiable and nonquantifiable costs that are likely to occur solely as a result 

of compliance; (4) incremental costs and benefits of rule options; (5) effects of the contaminant 

on the general population and sensitive subpopulations including infants, children, pregnant 

women, elderly, and individuals with a history of serious illness; (6) any increased health risks 

that may occur as a result of compliance, including risks associated with co-occurring 

contaminants; and (7) other relevant factors such as uncertainties in the analysis and factors with 

respect to the degree and nature of risk. A summary of these elements is provided in this section 

of the preamble, and a complete discussion can be found in the RTCR EA. 

Both benefit and cost measures are adjusted using social discounting. In social discounting, 

future values of a rule’s or policy’s effects are multiplied by discount factors. The discount 

factors reflect both the amount of time between the present and the point at which these events 

occur and the degree to which current consumption is more highly valued than future 
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consumption (USEPA 2000a). This process allows comparison of cost and benefit streams that 

are variable over a given time period. EPA uses social discount rates of both three percent and 

seven percent to calculate present values from the stream of benefits and costs and also to 

annualize the present value estimates. Historically, the use of three percent is based on after tax 

rates of return to consumers on relatively risk-free financial instruments, while seven percent is 

generally an estimate of average economy-wide before-tax rate of return to incremental private 

investment generally. For further information, see USEPA 2000a and OMB 1996. 

The time frame used for both benefit and cost comparisons in this rule is 25 years. This time 

interval accounts for rule implementation activities occurring soon after promulgation (e.g., 

States adopting the criteria of the regulation) and the time for different types of compliance 

actions (e.g., assessments and corrective actions) to be realized up through the 25th year 

following rule promulgation. In the RTCR EA, EPA also presents the undiscounted stream of 

benefits and costs over the 25-year time frame in constant $2007 dollars (2007$). (i.e., the yearto-year realization of benefits and costs presented in constant nominal terms).

The benefits described in this section are discussed qualitatively, and reductions in detection 

occurrence of total coliforms and E. coli and in Level 2 assessments are used to describe the as 

indicators of positive benefits. EPA was unable to quantify health benefits for the RTCR 

because there are insufficient data reporting the co-occurrence in a single sample of fecal 

indicator E. coli and pathogenic organisms. In addition, the available fecal indicator E. coli data 

from the Six-Year Review 2 dataset (USEPA 2012a) described in this preamble were limited to 

presence-absence data because the 1989 TCR requires only the reporting of presence or absence 

of fecal indicator E. coli using EPA-approved standard methods. However, as discussed in 

chapter 6 of the RTCR EA, even though health benefits could not be directly quantified, the 

Comment [EPA118]: ok

Comment [EPA119]: We think 

“constant” is correct as it refers to 

$2007 but suggest deleting text as 

shown

JL: OK, I misunderstood. It is 

helpful to make this clear.

EPA – ok with edits on this page

Comment [JL120]: Increase or 

decrease?

Comment [EPA121]: Revised. 

Consistent with language on 139.
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potential benefits from the RTCR include avoidance of a full range of health effects from the 

consumption of fecally contaminated drinking water, including the following: acute and chronic 

illness, endemic and epidemic disease, waterborne disease outbreaks, and death. Also, sSince 

fecal contamination may contain waterborne pathogens including bacteria, viruses, and parasitic 

protozoa, in general, a reduction in fecal contamination should reduce the risk from these other

all of these contaminants.

The net costs of the rule stem mostly from the new assessment and corrective action 

requirements as well as the revised monitoring provisions described earlier in this preamble. The 

costs discussed in this section are presented as annualized present values in constant 2007$

dollars. 

This section of the preamble includes elements as follows: (A) Regulatory Options 

Considered, (B) Major Sources of Data and Information Used in Supporting Analyses, (C) 

Occurrence and Predictive Modeling, (D) Baseline Profiles, (E) Anticipated Benefits of the 

RTCR, (F) Anticipated Costs of the RTCR, (G) Potential Impact of the RTCR on Households, 

(H) Incremental Costs and Benefits, (I) Benefits from Simultaneous Reduction of Co-occurring 

Contaminants, (J) Change in Risk from Other Contaminants, (K) Effects of Fecal Contamination 

and/or Waterborne Pathogens on the General Population and Sensitive Subpopulations, (L) 

Uncertainties in the Benefit and Cost Estimates for the RTCR, (M) Benefit Cost Determination 

for the RTCR, (N) Comments Received in Response to EPA’s Requests for Comment, and (O) 

Other Comments Received by EPA.

A. Regulatory Options Considered 

EPA evaluated the following three regulatory options as part of this revised rule: (1) the 

1989 TCR option, (2) the RTCR option (today’s final rule), and (3) an Alternative option. EPA 

Comment [JL122]: This is the 

mechanism by which the benefits in 

the prev sentence occur, not an 

additional benefit.

Comment [EPA123]: ok
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discusses the three regulatory options briefly in this preamble and in greater detail in chapter 3 of 

the RTCR EA. 

First, the 1989 TCR option reflects EPA’s understanding of how the 1989 TCR is currently 

being implemented. That is, the 1989 TCR option is assumed to include “status quo” PWS and 

State implementation practices. Next, the RTCR option is based on the provisions of this final 

rule as described in detail in section III of this preamble, Requirements of the Revised Total 

Coliform Rule. Third, the Alternative option parallels the RTCR in most ways but includes 

variations of some of the provisions that were discussed by the advisory committee before they 

reached consensus on the recommendations in their AIP, which served as the basis for the 

proposed and final rules. 

The Alternative option differs from the RTCR option in two ways. First, under the 

Alternative option, at the compliance date all PWSs are required to sample monthly for an initial 

period until they meet the eligibility criteria for reduced monitoring. EPA assumes that 

eligibility for reduced monitoring is determined during the next sanitary survey following the 

RTCR compliance date. This more stringent approach differs from the RTCR option that allows 

PWSs to continue to monitor at their current frequencies (with an additional annual site visit or 

voluntary Level 2 assessment requirement for PWSs wishing to remain on annual monitoring) 

until they are triggered into an increased sampling frequency. Second, under the Alternative 

option, no PWSs are allowed to reduce monitoring to an annual basis. EPA defined the 

Alternative option this way and included it in the RTCR EA to assess the relative impacts of a 

more stringent rule and to better understand the balance between costs and public health 

protection. EPA wishes to emphasized that it is not adopting the Alternative Option, but is 
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providing cost and benefit information on it as a point of comparison with the final rule as 

promulgated.

To understand the relative impacts of the options, EPA gathered available data and 

information to develop and provide input into an occurrence and predictive model. EPA 

estimated both baseline conditions and changes to these conditions anticipated to occur over time 

as a result of these revised rule options. The analysis is described in more detail in the RTCR 

EA.

B. Major Sources of Data and Information Used in Supporting Analyses

This section of the preamble briefly discusses the data sources that EPA used in its 

supporting analyses for the RTCR. For a more detailed discussion, see chapter 4 of the RTCR 

EA.

1. Safe Drinking Water Information System Federal vVersion data

Safe Drinking Water Information System Federal Version (SDWIS/FED) is EPA’s national 

regulatory compliance database for the drinking water program and is the main source of PWS 

inventory and violation data for the RTCR baseline. SDWIS/FED contains information on each 

of the approximately 155,000 active PWSs as reported by primacy agencies, EPA Regions, and 

EPA headquarters personnel. SDWIS/FED includes records of MCL violations and monitoring 

and reporting (MR) violations (both routine and repeat and minor and major). It does not include 

sample results. It also contains information to characterize the US inventory of PWSs including 

system name and location, retail population served, source water type (ground water (GW), 

surface water (SW), or ground water under the direct influence of surface water (GWUDI)), 

disinfection status, and PWS type (community water system (CWS), transient non-community 

water system (TNCWS), and non-transient non-community water system (NTNCWS)). 

Comment [EPA124]: ok
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To create the PWS and population baseline, EPA used the fourth quarter of SDWIS/FED 

2007 (USEPA 2007b), which was the most current PWS inventory data available when EPA 

began developing the RTCR EA. These data represent all current, active PWSs and the 

population served by these systems. 

EPA also used the MCL violation data from SDWIS/FED to validate model predictions for 

systems serving 4,100 or fewer people and to predict E. coli (or “acute,” under the 1989 TCR)

MCL violations (1989 TCR, RTCR, and Alternative option), total coliform (non-acute or 

monthly) MCL violations (1989 TCR), and Level 1 and Level 2 assessment triggers (RTCR and 

Alternative option) for systems serving more than 4,100 people.

2. Six-Year Review 2 data

Through an Information Collection Request (ICR) (USEPA 2006b), States voluntarily 

submitted electronically available 1989 TCR monitoring data1 (sample results) that were 

collected between January 1998 and December 2005. EPA requested the 1989 TCR monitoring 

results with the intent of conducting analyses and developing models to assess the potential 

impacts of changes to the 1989 TCR. EPA received data from 46 States, Tribes, and territories. 

A Data Quality Report (USEPA 2010c) describes how the 1989 TCR monitoring data were 

obtained, evaluated, and modified where necessary to make the database internally consistent 

and usable for analysis. Exhibit 2.1 in the Data Quality Report provides a complete list of States 

or territories that submitted data and a description of the use of these data. 

In this EA, EPA included data from 37 primacy agencies (35 States and 2 Tribes). Records 

included data for: 

• PWS information (system type, population served, source water type)

• Sample type (routine, repeat, special purpose)

 1 This refers to results of monitoring conducted pursuant to the 1989 TCR, not results from the year 1989.

Comment [EPA125]: ok
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• Analytical result

• Sampling location – entry point, distribution system and, for repeat samples, original 

location, downstream, upstream, and other

• Analytical method 

• Disinfectant residual data collected at TCR monitoring sites

As discussed in greater detail in section 4.2.2.1 of the RTCR EA, EPA used 2005 data 

exclusively in the analyses supporting the RTCR because the 2005 data set was the most 

complete year of data among the Six-Year Review 2 data. The 2005 data was also the most 

recent data available suggesting that it may be the most representative of present conditions. 

The Six-Year Review 2 data also informed EPA’s assumptions regarding the proportions of 

GWSground water systems serving 1,000 or fewer people that sample monthly, quarterly, or 

annually.

3. Other information sources

Additional data and information sources included the Economic Analysis for the Ground 

Water Rule (GWR EA) (USEPA 2006a), the Technology and Cost Document for the Revised 

Total Coliform Rule (RTCR T&C document) (USEPA 2012b), the US Census data, and the 

knowledge and experience of stakeholders representing industry, States, small systems, and the 

public. 

The GWR EA provided occurrence information on E. coli in the source water of ground 

water PWSs for modeling the triggered monitoring component of GWR and informed the 

assumptions on the distribution of corrective actions taken in response to the presence of E. coli

in the source water. As discussed in section VI.C of this preamble, Occurrence and Predictive 

Modeling, the model developed for this economic analysis considers the effect of GWR both 
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before and during implementation of the RTCR. The RTCR T&C document included estimates 

of unit costs for the major components of the RTCR that were obtained from the advisory 

committee technical workgroup and vendors, including labor, monitoring, assessments, and 

corrective actions. 

US Census data were used to estimate population per household and to characterize sensitive 

subpopulations. Lastly, knowledge and experience from stakeholders helped to inform the 

assumptions that were made for the analysis.

A more detailed discussion of these data sources and how EPA used them are included in the 

RTCR EA.

C. Occurrence and Predictive Modeling

EPA used the data to develop an occurrence and predictive model for PWSs serving 4,100 or 

fewer people based primarily on the 2005 Six-Year Review 2 data. The model predicts changes 

in total coliform and E. coli occurrence, Level 1 and Level 2 assessments (based on simulated 

monitoring results), corrective actions, and violations over time. EPA developed another simpler 

predictive model for PWSs serving more than 4,100 people that predicts Level 1 and Level 2 

assessments (based on 2005 violation data from SDWIS/FED), corrective actions, and violations 

over time, but not total coliform and E. coli occurrence. EPA modeled systems serving more 

than 4,100 people separately because the Six-Year Review 2 data for larger PWSs were not as 

robust as the data for the smaller systems. In addition, while the RTCR includes new monitoring 

requirements for PWSs serving 4,100 people or fewer, monitoring requirements for systems 

serving greater than 4,100 people remain essentially unchanged from the 1989 TCR. This 

section briefly discusses the structures of each of the two models and how they used available 

Comment [EPA126]: Added text to 

specify sources

Comment [JL127]: Where did this 

info come from? The T&C document 

is not a “source” since you prepared it.
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data, information, and assumptions to make predictions over time resulting from the regulatory 

options. 

Chapter 5 of the RTCR EA includes a more detailed description of the occurrence and 

predictive model used for PWSs serving 4,100 or fewer people, and the other simpler predictive 

model used for PWSs serving greater than 4,100 people.

1. Model used for PWSs serving ≤ 4,100 people

The occurrence and predictive model used for PWSs serving 4,100 or fewer people has two 

components. The first component of the model characterized how the presence or positive rates 

of total coliform and E. coli detections vary across the population of small (serving 4,100 or 

fewer people) public water systems in the US. These rates vary by the type of sample (routine or 

repeat), by analyte (total coliforms or E. coli), and by system type (CWS, NCWS, or TNCWS) 

and size. The second component of the model used the total coliform and E. coli occurrence 

distributions to simulate a set of nationally-representative systems within the context of the three 

regulatory options (1989 TCR, RTCR, and Alternative) to predict changes in total coliform and 

E. coli occurrence, triggers, assessments, corrective actions over time, and violations. 

The model assumed that the national occurrence of total coliforms and E. coli has reached a 

steady state in recent years under the 1989 TCR. It assumed that cycles of normal deterioration 

and repair/replacement are occurring at the individual system level, but the numbers of violations 

at the national level have remained relatively unchanged. This assumption is based on 

evaluation of SDWIS/FED violation data. Exhibit VI-1 presents the number of PWSs with 

violations from 2001-2007 under the 1989 TCR which shows that national violation rates have 

remained relatively steady over recent years. The RTCR will affect this steady state, likely 

resulting in a reduction of the underlying occurrence and associated violations. 
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Exhibit VI-1 Number of PWSs with Violations by System Type (2001 – 2007)

PWS Type Year

2001 2002 2003 2004 2005 2006 2007

Acute MCL Violations

CWS 143 144 185 171 151 171 171

NTNCWS 51 53 70 58 65 68 45

TNCWS 261 278 322 351 349 361 295

All 455 475 577 580 565 600 511

Non-Acute MCL Violations

CWS 2,074 2,110 2,204 2,314 2,196 2,095 1,996

NTNCWS 601 679 725 750 753 735 655

TNCWS 2,707 2,934 3,036 3,132 3,039 3,244 3,209

All 5,382 5,723 5,965 6,196 5,988 6,074 5,860

Note: PWSs counts are of systems that had at least one violation during the year.

Source: SDWIS/FED annual data for period ending 3rd quarter 2001-2007. OH, US territories, Tribal PWS data 

excluded.

Before the RTCR goes into effect, GWR implementation begins and is also expected to 

affect the steady state. To estimate the effects that GWR implementation is expected to have on 

present steady state conditions, EPA used the occurrence and predictive model to simulate five 

years of implementation of the 1989 TCR with the GWR, which became effective in December 

2009. EPA assumed these five years to account for the approximately two years before the 

expected promulgation date of the final RTCR and an additional three years after that until the 

RTCR effective date. The assumptions made to account for the GWR are described in detail in 

the in the RTCR EA and summarized in Exhibit VI-2.

Exhibit VI-2 Summary of Major Assumptions for Simulating GWR Implementation

GWR Provision Modeling Approach / 

Assumption

Triggered Monitoring: GWSs Ground water systems 

not providing 4-log treatment for viruses that have total 

coliform-positive samples under the 1989 TCR are 

required to take source water samples and test for a 

fecal indicator. If the sample is positive, they must take 

Current model used same probabilities used in GWR EA 

(USEPA 2006a) to predict whether source water samples 

will be E. coli-positive.

GWSs Ground water systems required to conduct 
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an additional 5 source water samples (unless the State 

requires corrective action). If any of these is positive, 

they must conduct corrective action.

corrective action due to monitoring results will either 

install disinfection or implement a nondisinfecting 

corrective action as described in the RTCR EA.

GWSs Ground water systems installing disinfection will 

draw from the probability distributions for total coliforms 

and E. coli for disinfected systems for the remainder of 

analysis.

GWSs Ground water systems implementing a 

nondisinfecting corrective action will experience no 

positive samples for the remainder of the year plus two 

additional years and will experience a 751 percent 

reduction in occurrence for five additional years.

Sanitary Surveys: GWR includes Federal sanitary 

survey requirements for all GWSsground water 

systems, and requires States to perform regular 

comprehensive sanitary surveys including eight critical 

elements. 

Model did not explicitly simulate sanitary surveys or their 

results. Rather, it assumed that the new sanitary survey 

provisions will result in 10 percent2 reduced occurrence 

of total coliforms universally for entire analysis.

Compliance Monitoring: GWSs Ground water 

systems that provide 4-log treatment for viruses must 

demonstrate that they are providing this level of 

treatment by conducting compliance monitoring.

Model did not explicitly simulate compliance monitoring. 

Rather, it assumed that the provision will result in 10 

percent3 reduced occurrence of total coliforms for those 

GWSs ground water systems that are conducting 

compliance monitoring once assumed 4-log treatment for 

viruses begins.

1,2,3Assumption reflects EPA best professional judgment.

Source: RTCR EA (USEPA 2012a) as informed by GWR EA (USEPA 2006a). 

Actual reductions in occurrence from the implementation of GWR requirements may differ 

from what is presented here. However, based on assumptions used in this model, the analysis of 

how the RTCR and Alternative option perform relative to each other are not affected. 

In addition to capturing the effect of implementation of GWR requirements with the 1989 

TCR for a five-year period of analysis, the model captures an additional 25 years with the 1989 

TCR, the RTCR option, and the Alternative option. Along with changes in total coliform and E. 

coli occurrence, the model predicts behavioral changes: the number of Level 1 and Level 2 

assessments (and associated Level 1 or Level 2 corrective actions) to be performed, further 

resulting adjustments to occurrence, and changes in sampling regimens as systems qualify for 
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reduced monitoring requirements. The assumptions used to simulate RTCR implementation are 

detailed in the RTCR EA and summarized in Exhibit VI-3.

Exhibit VI-3 Summary of Major Assumptions for Simulating RTCR Implementation

RTCR Provision Modeling Approach / Assumption

Level 1 Assessment Model simulates sampling and sampling results and determines which PWSs will be 

triggered to conduct an assessment. 

Sanitary defects are found in 10 percent1 of assessments (represents net increase over 

the 1989 TCR). 

All sanitary defects are corrected. Model selects from distribution of potential 

corrective actions as explained in chapter 7 of the RTCR EA (USEPA 2012a).

PWSs implementing a corrective action as a result of a Level 1 assessment experience 

no positive samples for the remainder of the year plus one additional year and will 

experience 50 percent2 reduction in occurrence for three additional years.

Level 2 Assessment Model simulates sampling and sampling results and determines which PWSs will be 

triggered to conduct an assessment. 

Sanitary defects will be found in 10 percent3 of assessments (represents net increase 

over the 1989 TCR). 

All sanitary defects are corrected. Model selects from distribution of potential 

corrective actions as explained in chapter 7 of the RTCR EA (USEPA 2012a).

PWSs implementing a corrective action as a result of a Level 2 assessment will 

experience no positive samples for the remainder of the year plus two additional years 

and will experience 75 percent4 reduction in occurrence for five additional years.

1,3Assumption based on conversation with State representatives with on-the-ground experience. 2,4Assumption reflects EPA best professional judgment.

Note: EPA recognizes that there is a large uncertainty with the assumptions. Sensitivity analyses showed that the 

fundamental conclusions of the economic analysis do not change over a wide range of assumptions tested.

Source: RTCR EA (USEPA 2012a)

EPA made different assumptions for the effectiveness of assessments and subsequent 

corrective actions to account for the differences between the two types of assessments. The 

Level 2 assessment is a more comprehensive investigation that may result in finding more 

substantial problems than what may be found during a Level 1 assessment, and for that reason 
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the corrective actions that result from a Level 2 assessment were modeled to result in corrective 

action measures that are generally more expensive and have bigger and longer lasting effects 

than those of the Level 1 assessments. EPA conducted sensitivity analyses around the key 

assumptions summarized in Exhibit VI-2 as discussed in section VI.L of this preamble, 

Uncertainties in the Benefit and Cost Estimate for the RTCR.

2. Model used for PWSs serving > 4,100 people

For systems serving more than 4,100 people, EPA estimated violation and trigger rates using 

SDWIS/FED because the Six-Year Review 2 data for PWSs serving more than 4,100 people 

were not as robust as the Six-Year Review 2 data for systems serving 4,100 or fewer people. 

EPA did not quantify changes in violation or trigger rates for systems serving more than 4,100 

people among the 1989 TCR, RTCR, and Alternative options because of: (1) limited Six-Year 

Review 2 data to characterize these systems, (2) the essentially unchanged monitoring 

requirements across options for these systems, and (3) the level of effort already occurring to 

implement the 1989 TCR.

D. Baseline Profiles 

The estimate of baseline conditions that EPA developed provides a reference point for 

understanding net impacts of the RTCR. 

Compliance with the GWR began in December 2009, and the expected compliance date of 

the RTCR is approximately five six years following commencement of the GWR 

implementation. The majority of PWSs are GWSground water systems and these systems are 

expected to be affected by the GWR. Because GWR implementation prior to the effective date 

of RTCR is expected to cause changes to GWSground water systems, the baseline conditions 

that EPA developed for GWSground water systems account for the expected effects of the GWR. 

Comment [JL128]: Were they also 

modeled to be more costly on average. 

That is the more substantial corrective 

actions have a higher probability of 

being selected.

Comment [EPA129]: Yes –see 

section 7 of the EA and sections 4 and 

5 of RTCR Technology & Cost 

document. Corrective actions 

requiring more capital expense 

(replacement of lines, installation of 

appurtenances) were assumed to be 

done more frequently as a result of a 

Level 2 assessment; less costly items 

like flushing and sampler training 

were assumed to be done more 

frequently as a result of a Level 1.

OK with edits to this sentence

Comment [EPA130]: Changed due to 

delay in expected signature date.
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For PWSs serving more than 4,100 people, EPA assumed that present conditions, as reflected 

in 2005 SDWIS/FED data, are an appropriate representation of the conditions that are likely to 

exist when the RTCR becomes effective. EPA assumed that a steady state exists at the national 

level. 

The number of GW ground water PWSs that disinfect is expected to change during 

implementation of the GWR before the expected rule compliance date of the RTCR. Exhibit VI4 shows the estimated baseline number of the ground water GW PWSs at the RTCR compliance 

date.

Exhibit VI-4 Estimated Baseline Number of GW Ground Water Systems and

Disinfection Status at compliance date (3 years post RTCR promulgation)

PWS Size

Number of GW Ground Water PWSs (Post-GWR)

CWS NTNCWS TNCWS

Disinfecting Non-Disinfecting Disinfecting Non-Disinfecting Disinfecting Non-Disinfecting

≤100 6,190 5,748 2,938 5,888 13,753 46,447

101-500 9,311 4,581 2,776 3,837 5,451 13,824

501-1,000 3,512 955 873 845 684 1,279

1,001-4,100 5,422 1,021 547 265 274 343

4,101-33,000 2,798 358 56 14 27 40

33,001-96,000 307 28 2 - - 2

96,001-500,000 62 1 - - - 1

500,001-1 M 4 - - - - 1

>1 M 3 - - - - -

Total 27,610 12,691 7,191 10,850 20,189 61,937

Combined Total 40,301 18,041 82,126

Source: RTCR Occurrence and Predictive Model Output as detailed in the RTCR EA (USEPA 2012a)

EPA estimated the numbers of ground water GW PWSs that monitor monthly, quarterly, and 

annually under the 1989 TCR based on an analysis of the Six-Year Review 2 data and individual 

State statutes conducted by EPA and the advisory committee Technical Work Group (TWG). Of 

the ground water GW PWSs serving 1,000 or fewer people, EPA estimated that approximately 

34,000 monitor monthly, 67,000 monitor quarterly, and 27,000 monitor annually. EPA assumed 

that the numbers of systems on monthly, quarterly, and annual monitoring remain unchanged at 

the rule effective date for either a continuation of the 1989 TCR. or fFor the RTCR option, EPA 
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assumed that only the percentage of systems that received an annual site visit under the 1989 

TCR would continue on annual monitoring under the RTCR; the percentage of systems that 

would therefore no longer qualify for annual monitoring under the RTCR were assumed to revert 

to baseline quarterly monitoring. Under the Alternative option, all PWSs, regardless of size or 

type, start at monthly monitoring at the rule effective date. 

The following two tables provide an overview of summary statistics relating to baseline 

water quality. Exhibit VI-5 shows the percentage of total coliform- and E. coli-positive samples 

based on PWS type and size. The percentages of samples that are total coliform-positive are 

generally higher in ground water systems than in surface water systems; in smaller systems than 

in larger systems; and in NCWSs than in CWSs. 

Exhibit VI-5 Total Coliform and E. coli Percent Positive by System Size and Type

PWS

Type

Source

Water

Population

Served

Total 

Coliform

(# Samples) 

Total 

Coliform

(+ Samples) 

Total 

Coliform

(% Positive)

ECE. coli

(# Samples)1

E. coliC

(+ Samples) 

E. coliC

(% Positive)2

CWS

Ground 

Water (GW)

≤100 93,105 2,479 2.66% 1,172 72 0.08%

101 - 500 125,490 2,500 1.99% 1,639 61 0.05%

501-1,000 48,265 736 1.52% 483 20 0.04%

1,001-4,100 110,391 1,176 1.07% 732 21 0.02%

4,101-33,000 183,721 877 0.48% 458 22 0.01%

33,001-100,000 96,361 214 0.22% 44 2 0.00%

>100,000 64,965 289 0.44% 34 1 0.00%

Total GW 722,298 8,271 1.15% 4,562 199 0.03%

Surface 

Water (SW)

≤100 6,735 95 1.41% 64 6 0.09%

101 - 500 19,716 227 1.15% 159 10 0.05%

501-1,000 12,828 90 0.70% 70 7 0.05%

1,001-4,100 55,310 314 0.57% 233 17 0.03%

4,101-33,000 175,758 525 0.30% 399 41 0.02%

33,001-100,000 112,894 157 0.14% 106 5 0.00%

>100,000 112,143 235 0.21% 99 2 0.00%

Total SW 495,384 1,643 0.33% 1,130 88 0.02%

GW & SW Total CWS 1,217,682 9,914 0.81% 5,692 287 0.02%

TNCWS

GW

≤100 163,730 7,820 4.78% 5,820 316 0.20%

101 - 500 52,891 2,418 4.57% 1,869 99 0.19%

501-1,000 6,952 299 4.30% 217 4 0.06%

>1,000 7,062 143 2.02% 85 2 0.03%

Total GW 230,635 10,680 4.63% 7,991 421 0.18%

SW

≤100 6,723 150 2.23% 141 17 0.25%

101 - 500 2,854 75 2.63% 69 13 0.46%

501-1,000 523 19 3.63% 19 - 0.00%

>1,000 988 6 0.61% 37 - 0.00%

Total SW 11,088 250 2.25% 266 30 0.27%

GW & SW Total TNCWS 241,723 10,930 4.52% 8,257 451 0.19%

NTNCWS GW

≤100 46,505 1,476 3.17% 1,061 34 0.07%

101 - 500 33,084 893 2.70% 628 19 0.06%

501-1,000 9,531 166 1.74% 103 2 0.02%

>1,000 13,138 177 1.35% 103 5 0.04%

Total GW 102,258 2,712 2.65% 1,895 60 0.06%

SW ≤100 1,668 32 1.92% 30 4 0.24%

Comment [EPA131]: Edits made 

after document was sent to OMB on 

7/24, OMB changed “monitor at” to 

“revert to”
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101 - 500 2,304 9 0.39% 9 2 0.09%

501-1,000 932 6 0.64% 5 - 0.00%

>1,000 1,316 1 0.08% 1 - 0.00%

Total SW 6,220 48 0.77% 45 6 0.10%

GW & SW Total NTNCWS 108,478 2,760 2.54% 1,940 66 0.06% 1 Number of E. coli samples that were specifically tested for e-coliE. coli. is tThe denominator of the E. coli percent 

positive calculation, and includes this number plus the number of total coliform negative samples (number of total 

coliform samples – number of total coliform-positive samples)TC #samples – TC +samples)plus the number of total 

coliform-positive samples that were tested for E. coli. 2 Percent of E. coli-positive was calculated as (number of E. coli-positive samples) / (number of E. coli samples 

taken) x 100.

Source: Derived using Six-Year Review 2 Data, which was filtered by including a State only if the State’s PWSs as 

a group had submitted at least 50 percent of the expected sample-months of usable data. The Total Coliform 

Compliance Monitoring Data Quality and Completion Report (USEPA 2010b) includes a detailed description of this 

data cleaning process.

Exhibit VI-6 presents the number of acute and non-acute violations reportedceived by PWSs. 

The number of violations is also an indicator of baseline water quality prior to implementation of 

the RTCR. As discussed in detail chapter 5 of the RTCR EA, EPA used these data to estimate 

the numbers of MCL violations and triggers for PWSs serving more than 4,100 people for the 

three options. Under the 1989 TCR, larger systems incur a relatively small number of violations 

annually, while smaller systems incur the majority.

Exhibit VI-6 Baseline Number of TCR Violations by System Size and Type (2005)

Ground Water PWSs Surface Water PWSs All PWSs 

Non Total -Acute Acute Total Non-Acute Acute Total

CWSs

<100 905 52 957 16 3 19 976 

101-500 809 34 843 50 7 57 900 

501-1,000 203 13 216 16 3 19 235 

1,001-3,300 272 8 280 55 7 62 342 

3,301-10,000 171 8 179 75 3 78 257 

10,001-50,000 125 8 133 78 4 82 215 

50,001-100,000 11 2 13 5 4 9 22 

100,001-1 Million 1 1 2 4 1 5 7 

> 1 Million - - - - - - - 

Total CWSs 2,497 126 2,623 299 32 331 2,954 

NTNCWSs

<100 514 34 548 7 2 9 557 

101-500 346 20 366 4 - 4 370 

501-1,000 57 6 63 2 - 2 65 

1,001-3,300 58 4 62 - - - 62 

3,301-10,000 9 2 11 1 - 1 12 

10,001-50,000 1 - 1 - - - 1 

50,001-100,000 - - - - - - - 

100,001-1 Million 1 - 1 - - - 1 

> 1 Million - - - - - - - 

Total NTNCWSs 985 66 1,051 14 2 16 1,067 

TNCWSs

Comment [JL132]: This is the 

number you used in the calculation, 

but not the number in the column. 

The column includes only samples 

specifically tested for e coli. Please 

clarify this in the explanation—see 

suggested language.

Comment [EPA133]: OK, correct, 

thanks.
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<100 2,665 278 2,943 19 5 24 2,967 

101-500 833 76 909 11 1 12 921 

501-1,000 133 11 144 4 - 4 148 

1,001-3,300 58 2 60 1 - 1 61 

3,301-10,000 5 - 5 1 - 1 6 

10,001-50,000 - - - - - - - 

50,001-100,000 - - - - - - - 

100,001-1 Million - - - - - - - 

> 1 Million - - - - - - - 

Total TNCWSs 3,694 367 4,061 36 6 42 4,103 

Grand Total 7,176 559 7,735 349 40 389 8,124 

Note: The RTCR EA uses violations data for PWSs serving greater than 4,100 people to estimate triggers for these 

systems. Data for other system sizes is provided for reference.

Source: Acute/Non-Acute Violations from SDWIS/FED annual data for period ending 3rd quarter 2001 – 2007 

(only 2005 data is presented in this exhibit). OH, U.S. territories, Tribal PWS data excluded. See the RTCR EA 

(USEPA 2012a) for additional details.

E. Anticipated Benefits of the RTCR

In promulgating the RTCR, EPA expects to further reduce the risk of contamination of public 

drinking water supplies from the current baseline risk under the 1989 TCR. The options 

considered during development of this rule and analyzed as part of the RTCR EA are designed to 

achieve this reduction while maintaining public health protection in a cost-effective manner.

This section examines the benefits in terms of trade-offs among compliance with the 1989 

TCR option, the RTCR option, and the Alternative option. Because there are insufficient data 

reporting the co-occurrence in a single sample of fecal indicator E. coli and pathogenic 

organisms and because the available fecal indicator E. coli data from the Six-Year Review 2 

dataset were limited to presence-absence data, EPA was unable to quantify health benefits for the 

RTCR. EPA used several methods to qualitatively evaluate the benefits of the RTCR options. 

The qualitative evaluation uses both the judgment of EPA as informed by the TCRDSAC 

deliberations as well as quantitative estimates of changes in total coliform occurrence and counts 

of systems implementing corrective actions. The evaluation characterizes, in relative terms, the 

reduction in risk for each regulatory scenario as compared to baseline conditions. 

Since E. coli is an indicator of fecal contamination, EPA assumed that a decrease in E. coli

occurrence in the distribution system would be associated with a decrease in fecal contamination 
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in the distribution system. In general, this decrease in fecal contamination should reduce the 

potential risk to human health for PWS customers. Thus, any reduction in E. coli occurrence is 

considered a benefit of the RTCR. Also, sSince fecal contamination may contain waterborne 

pathogens including bacteria, viruses, and parasitic protozoa, in general, a reduction in fecal 

contamination should also reduce the risk from all of these other contaminants.

As presented in Exhibit VI-5, the percentages of samples that are positive for total coliforms 

and E. coli are generally higher for PWSs serving 4,100 or fewer people than those serving more 

than 4,100 people. PWSs with higher total coliform and E. coli occurrence are more likely to be 

triggered into assessments and corrective action. As discussed previously, the assessments and 

corrective action lead to a decrease in total coliform and E. coli occurrence. Because the PWSs 

serving 4,100 or fewer people have a higher initial E. coli occurrence and are likely triggered 

into more assessments and corrective actions than larger PWSs, the increase in benefits for these 

small systems are likely more evident as compared to the larger systems. In particular, model 

results suggest that customers of small ground water TNCWSs serving 100 or fewer people, 

which constitute approximately 40 percent of PWSs, experience the most improvement in water 

quality under the RTCR. That is, the occurrence of E. coli is predicted to decrease more for 

these systems than for other systems types.

1. Relative risk analysis

When revising an existing drinking water regulation, one of the main concerns is to ensure 

that backsliding on water quality and public health protection does not occur. SDWA requires 

that EPA at least maintain or improve public health protection for any rule revision. The RTCR 

is more stringent than the 1989 TCR with regard to protecting public health. The basis for this 

perspective is provided in this subsection and the following subsections (sections VI.E.2, 
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Changes in violation rates and corrective actions, and VI.E.3, Nonquantifiable benefits) of this 

preamble. 

Risk reduction for the RTCR is characterized by the activities performed that are presumed to 

reduce risk of exposing the public to contaminated water. These activities are considered under 

each rule component presented in Exhibit VI-8. 

More frequent monitoring has the potential to decrease the risk of contamination in PWSs 

based on an enhanced ability to diagnose and mitigate system issues in a more timely fashion. 

Conversely, less frequent monitoring has the potential to increase risk. Real-time continuous 

sampling would mitigate the most risk possible based on sampling schedule; however, it would 

cost prohibitively more than the periodic sampling practiced under the 1989 TCR and included in 

the RTCR and the Alternative options. EPA’s objective in proposing the sampling schedules 

included in the RTCR and Alternative options was to find an appropriate balance between the 

factors of risk mitigation and cost management.

Under the RTCR and Alternative options, the reduction in the number of required repeat 

samples and additional routine samples for some PWSs has the potential to contribute to 

increased risk for PWS customers (see also section III.C, Monitoring, and III.D, Repeat Samples,

of this preamble for discussions on the additional routine sample and repeat sample provisions 

respectively). However, this potential increase in risk is expected to be more than offset by 

potential decreases in risk from increased routine monitoring (see section III.C of this preamble, 

Monitoring) and the addition of the assessments and corrective action provisions (see section 

III.E of this preamble, Coliform Treatment Technique) that find and fix problems indicated by 

monitoring. Exhibit VI-7 illustrates the predicted reduced frequency at which total coliforms 

occur subsequent to the implementation of the RTCR and Alternative options. As discussed 
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previously, the RTCR uses total coliform occurrence as an indicator of potential pathways for 

possible contamination to enter the distribution system (see section III.B of this preamble, Rule 

Construct: MCLG and MCL for E. coli and Coliform Treatment Technique). Exhibit VI-7 

illustrates the combined effects on total coliform occurrence resulting from changes in 

monitoring and the effects of assessments and corrective actions for the different rule options for 

very small systems. The relative trends indicated in Exhibit VI-7 for TNCWSs also pertain to 

other PWS categories as illustrated in chapter 5 of the RTCR EA. EPA chose to include the 

characterization for TNCWSs because they represent the system category of largest influence on 

the national impacts.

Exhibit VI-7 Ground Water Transient Non-community Water System (Summary of 

Systems Serving ≤ 4,100) Total Coliform Occurrence

Source: RTCR occurrence model as described in the RTCR EA (USEPA 2012a). 

Comment [EPA134]: Graph replaced 

to correct the y axis label. The old yaxis label was “Number of Positive 

TC Assays per Year.” 

11/15/12
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The effect that the elimination of public notification requirements for monthly/non-acute 

MCL violations has on risk is difficult to predict. Some factors, such as reduction in available 

public information and possible PWS complacency, lead to a potential increase in risk and other 

factors, such as less confusion (PN more in line with potential health risks) and PWSs resources 

used more efficiently, lead to a potential decrease, as discussed in Exhibit VI-8. This change to 

PN is addressing a key concern expressed by various stakeholders in the advisory committee and 

during the Six-Year Review 1 comment solicitation process. By eliminating the requirement and 

replacing it with assessment and corrective action requirements, the Agency expects less public 

confusion, more effective use of resources, and increased transparency, and increased public 

health protection. 

Other rule components are expected to have a negligible effect on risk. However, the overall 

effect of the RTCR is expected to be a further reduction in risk from the current baseline risk 

under the 1989 TCR. Chapter 6 of the RTCR EA presents a detailed discussion of the potential 

influence on health risk for each rule component.

Exhibit VI-8 Potential Changes in Risk under the RTCR and Alternative Options Relative 

to the 1989 TCR 

RTCR 

Component

Factors Leading to a Potential 

Increase in Risk

Factors Leading to a Potential Decrease in 

Risk

Overall Predicted Change in Risk

RTCR Alternative RTCR Alternative RTCR Alternative 

Implementation 

Activities None None None None No change No change

Routine 

Monitoring 

(Including 

Reduced 

Monitoring)

None None

Increased stringency 

in requirements to 

qualify for reduced 

monitoring along 

with requirement to 

return to baseline 

monitoring upon 

loss of these criteria 

is expected to result 

in decreased risk 

(That is, fewer 

PWSs will qualify 

PWSs all monitor 

monthly in the first 

few years of 

implementation of 

the RTCR, which is 

an increase in 

sampling frequency 

for systems that 

monitor quarterly or 

annually under the 

1989 TCR. After 

the first few years, 

Decrease Decrease
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and therefore PWSs 

will on average 

monitor more 

frequently than 

under the baseline 

for reduced 

monitoring)

systems may reduce 

to quarterly, but 

none may reduce to 

annual monitoring, 

creating a decrease 

in risk for systems 

on annual 

monitoring under 

the 1989 TCR

Repeat 

Monitoring

Required repeat 

samples reduced 

from 4 to 3 for 

systems serving 

<1,000 people

Same as RTCR 

option

None None Increase Increase

Additional 

Routine 

Monitoring

Additional 

routine samples 

are no longer 

required for 

PWSs 

monitoring 

monthly.

Ground water 

PWSs serving 

1,000 or fewer 

people reduce 

additional routine 

samples from 5 

to 3.

Same as RTCR 

option

None None Increase Increase

Annual Site 

Visits

None (only 

States currently 

performing 

annual site visits 

are expected to 

continue).

Annual 

monitoring is 

not permitted 

under the 

Alternative 

option, so the 

protective 

benefit of the 

annual site visit 

is lost.

None None No change Increase

Assessments None None

Mandatory 

assessments are a 

new requirement

Same as RTCR 

option Decrease Decrease

Corrective 

Actions None None

Mandatory 

corrective actions 

are a new 

requirement 

Same as RTCR 

option Decrease Decrease

Public 

Notification –

Monthly/NonAcute MCL 

Violations

Reduction in 

available public 

information

Possible PWS 

complacency

Same as RTCR 

option

Less confusion (PN 

more in line with 

potential health 

risks)

PWSs resources 

used more 

efficiently

Same as RTCR 

option Unknown Unknown

Public 

Notification –

Monitoring and 

Reporting 

Violations

None None

Increased stringency 

of PNs motivates 

PWSs to conduct 

required sampling

Same as RTCR 

option Decrease Decrease

Overall Decrease Decrease

Notes: Detailed discussion of the rationale for determinations of potential risk for each rule component is presented 

in chapter 6 (section 6.2) of the RTCR EA (USEPA 2012a). Implementation activities consist of administrative 

activities by PWSs and States to implement the rule. 

Assessment of potential changes in risk for monitoring components is an overall assessment. Potential changes (or 

static state) of risk for particular system sizes and types differ according to individual regulatory requirements and 
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are discussed in section 6.2 of the RTCR EA. Chapter 3 of the RTCR EA provides a detailed description of the 

regulatory components for all three regulatory scenarios, and this preamble provides additional discussion of the 

TCRDSAC process and the rationale underlying the structure of the regulatory options considered.

2. Changes in violation rates and corrective actions

The quantified portion of the benefits analysis focuses on several measures that contribute to 

the changes in risk expected under the RTCR. Specifically, EPA modeled the predicted 

outcomes based on each regulatory option considered – baseline (1989 TCR), the RTCR (final 

rule), and the Alternative option – in the form of estimates of non-acute violations for the 1989 

TCR and assessment triggers for the RTCR and Alternative option; E. coli violations; and the 

number of corrective actions implemented under each option. This section of the preamble 

includes six graphs (Exhibit VI-9 through Exhibit VI-14) that help to illustrate these endpoints.

Evaluation of each of these endpoints informed EPA’s understanding of potential changes to 

the underlying quality of drinking water. In particular, the number of corrective actions 

performed has a strong relationship to potential improvements in water quality and public health. 

For a given rate of total coliform and E. coli occurrence, an increase in the number of corrective 

actions implemented leads to improved water quality. However, a reduction in sampling likely 

leads to a reduction in total coliform and E. coli positives being found, which in turn likely leads 

to a reduction in assessments and corrective actions being implemented. The number of total 

coliform and E. coli positives that are prevented, missed, or found under each regulatory option 

considered in comparison to those predicted under the 1989 TCR results in estimates of annual 

non-acute and acute violations (1989 TCR) and assessment triggers (RTCR and Alternative 

options). Section 6.4 of the RTCR EA presents a step-wise sensitivity analysis of the competing 

effects of additional protective activity (e.g., assessments and corrective actions) and decreased 

additional routine and repeat sampling of the regulatory alternativesRTCR compared to the 1989 
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TCR. The results conclusions of this sensitivity analysis showed that for all categories of 

systems, more total coliform and E. coli positives are expected to be prevented than missed 

under the both RTCR regulatory options relative to the 1989 TCR.

For each of the graphs presented in Exhibit VI-9 through Exhibit VI-14, there are two main 

model drivers that affect the endpoints depicted: the total number of samples taken over time 

(including routine, additional routine, and repeat samples) and the effect of corrective actions 

taken. When looking at the comparisons between the 1989 TCR with the RTCR across all 

PWSs, the overall effect of the total numbers of samples taken is negligible because the total 

number of samples predicted to be taken throughout the period of analysis is almost the same 

(approximately 82 millionM samples) under both the 1989 TCR and RTCR. For the Alternative 

option, the analysis predicts that approximately 87 88 millionM total samples are taken over the 

period of analysis. Exhibit VI-18 of this preamble presents estimated total numbers of samples 

taken over the 25-year period of analysis. Based on the relationships of total samples taken 

among the 1989 TCR, RTCR, and Alternative options, the best way to interpret the graphs 

presented in this section is in a step-wise manner.

The first comparison that should be made is between the 1989 TCR option and RTCR

options. Because similar total numbers of samples are taken under the 1989 TCR and 

RTCReach option, the major effect seen in the graphs can be isolated to the effects that 

implementation of corrective actions has on underlying occurrence and how that occurrence 

influences the endpoint in question (assessments, E. coli MCL violations, and corrective actions). 

In each graph, this is depicted by a marked reduction in the endpoint under the RTCR option

compared to the 1989 TCR option and is a reflection of overall better water quality. The second 

comparison can then be made of the Alternative option against the RTCR option. In each graph, 

Comment [EPA135]: Revised to 

more correctly reflect the sensitivity 

analysis discussion in the EA.

11/15/12

Comment [EPA136]: REVISIONS 

BEGIN HERE TO CORRECT 

ALTERNATIVE OPTION VALUES 

Corrections to Alternative option 

number of samples (no annual 

monitoring allowed, therefore more 

samples taken)

11/15/12
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the predicted results (assessments, E. coli MCL violations, and corrective actions) for the 

Alternative option are above those for the RTCR option and represent an additional benefit over 

the RTCR option. This additional benefit is primarily a function of the additional diagnostic 

abilities gained through increased monitoring under the Alternative option, and is especially 

prominent in the early years of the analysis, since all systems are initially required to monitor at 

least monthly.

More detailed descriptions of each endpoint considered in terms of the evaluation process 

described previously are provided in this section as they apply to the individual graphs in Exhibit 

VI-9 through VI-14. Each of the graphs shown in this section is presented first in nondiscounted 

terms, and then based on a discount rate of three percent to reflect the reduced valuation of 

potential benefits over time, consistent with the presentation of costs in the section that follows. 

Graphs of benefits discounted using seven percent discounted rates are presented in Appendix B 

of the RTCR EA. 

Exhibit VI-9 shows the effect (on average across all PWSs) of the RTCR and the Alternative 

options on the annual number of non-acute violations (1989 TCR) and assessment triggers 

(RTCR and Alternative options) over time. The estimated reduction of annual assessment 

triggers (from the 1989 TCR estimates of non-acute violations) by approximately 1,000 events

under the RTCR option is a reflection of the improved water quality expected under the RTCR

option. A similar but smaller reduction in non-acute violations (Level 1 triggers) from the 1989 

TCR is seen under the Alternative option. The larger initial estimate of assessment triggers 

followed by a higher steady state number for the Alternative option than seen under the RTCR 

option reflects the diagnostic abilities provided by increased sampling under the Alternative 
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option. The additional triggers identified by increased sampling under the Alternative option 

translate into greater potential benefits than under the RTCR option. 

Exhibit VI-10 shows the effect (on average across all PWSs) of the RTCR and the 

Alternative option with respect to E. coli violations found over the 25-year period of analysis in 

comparison to the 1989 TCR. The overall reduction in annual E. coli violations under the RTCR 

option of more than 100 events is a measure that should correlate more closely with expected 

benefits (that is, reductions in adverse health outcomes) than non-acute events (as presented in 

Exhibit VI-9) because E. coli violations are a direct result of measurement of fecal contamination 

in water. A similar but smaller reduction in E. coli violations is seen under the Alternative 

option after steady state is achieved. This is the result of two off-setting effects. The “true” 

number of steady state violations under the Alternative option is lower because there is a greater 

likelihood that violations will be found and fixed. However, the additional monitoring leads to a 

higher percentage of violations being detected. This second effect outweighs the first, so that the 

total number of detected violations in the steady state is higher than for the RTCR, even though 

the underlying “true” number of violations is lower. This lower number of “true” violations 

means that the Alternative option is more protective of public health, even though more 

violations are detected. 

Exhibit VI-11 presents estimates over the 25-year period of analysis of the increase in 

corrective actions relative to the 1989 TCR (on average across all PWSs) attributable to the 

RTCR and Alternative optionregulatory options considered. Performance of these additional 

corrective actions is expected to result in the most direct benefits under the RTCR. Because only 

the incremental numbers of corrective actions estimated under the RTCR and Alternative options

were modeled, the reference point for comparison to the 1989 TCR is the base (zero) line in the 
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graph. The RTCR EA assumes that corrective actions are already being performed under the 

1989 TCR. Baseline corrective actions are taken into account by assuming only a modest 

incremental increase of 10 percent in implementation of effective corrective actions under both 

the RTCR and Alternative optionregulatory options considered. 

Exhibit VI-11 indicates that more corrective actions are implemented under the Alternative 

option than under the RTCR option. This is driven, again, by the increased diagnostic power of 

more sampling and reflects additional potential benefits beyond those gained under the RTCR

option. 

Taken together, Exhibit VI-9 through Exhibit VI-11 indicate that the modeled endpoints for 

the RTCR and the Alternative options predict positive benefits in comparison to the 1989 TCR; 

in particular, the Alternative option captures more benefits than the RTCR option. Similar to the 

patterns seen in Exhibits VI-9 through VI-11, for each of the discounted endpoints presented 

over time in Exhibits VI-12 though VI-14, the graphs show that (on average across all PWSs) the 

Alternative option provides more benefit than the RTCR, and both provide more benefit than the 

1989 TCR. These outcomes are consistent with the qualitative assessment of the benefits 

summarized in this section of this preamble. 

The major difference between the RTCR option and the Alternative option is the increased 

monitoring that is required under the Alternative option. The increased diagnostic ability of the 

extra samples taken under the Alternative option is seen in the large difference in the endpoint 

counts through the first several years in Exhibit VI-9 through Exhibit VI-14. Absent this effect, 

the Alternative option essentially mirrors the RTCR option in the exhibits. Even though the 

predicted results (assessments, E. coli MCL violations, and corrective actions) under the 

Alternative option are greater than the 1989 TCR at first, the trend is due to initially finding more 

Comment [EPA137]: Clarifying edits

11/15/12
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problems through monitoring. The increased monitoring during the first several years under the 

Alternative option results in a frontloading of benefits at the beginning of the implementation 

period. The benefits, however, tend to even out over time between the RTCR and Alternative 

option as eligible systems qualify for less intense (quarterly) monitoring under the Alternative 

option. However, the Alternative option leads to a greater number of assessments, E. coli MCL 

violations, and corrective actions than the RTCR option because all PWSs are required to sample 

no less than quarterly under the Alternative option while under the RTCR option qualifying 

PWSs are permitted to sample at a minimum of once per year: more monitoring has the potential 

for more triggered assessments, corrective actions, and/or violations than less monitoring. 
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Exhibit VI-9 Estimates of Non-Acute Violations (1989 TCR) and Level 1 Assessment 

Triggers (RTCR and Alternative Option)

Notes: X-axis begins at Year 4 after rule promulgation, which is the first year of full implementation of the RTCR 

and Alternative option. The annual rates of non-acute violations (1989 TCR) and Level 1 assessment triggers 

(RTCR and Alternative option) as predicted by the model reach a steady state beginning in approximately Year 9, by 

which time PWSs that are expected to meet the criteria for reduced monitoring begin reduced monitoring, and the 

distribution of PWSs thate monitor monthly, quarterly, and annually is assumed to remain relatively constant. 

Estimates represent the annual number of assessment triggers found by each option and the non-acute violations 

found under the 1989 TCR.

Source: RTCR occurrence model output.

Comment [EPA138]: Correction in 

this exhibit; the Alternative option line 

from Year 9 to Year 25 is now higher 

by approximately 500 triggers/year. 

11/15/12
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Exhibit VI-10 Estimates of Acute Violations (1989 TCR) and E. coli MCL Violations 

(RTCR and Alternative Options)

Notes: X-axis begins at Year 4 after rule promulgation, which is the first year of full implementation of the RTCR 

and Alternative option. The annual rates of acute violations (1989 TCR) and E. coli MCL violations (RTCR and 

Alternative option) as predicted by the model reach steady state in approximately Year 9, by which time PWSs that 

are expected to meet the criteria for reduced monitoring begin reduced monitoring, and the distribution of PWSs 

thate monitor monthly, quarterly, and annually is assumed to remain relatively constant. Estimates represent the 

annual number of acute violations found by each option and the 1989 TCR. 

Source: RTCR occurrence model output.

Comment [EPA139]: Correction in 

this exhibit; the Alternative option line 

from Year 9 to Year 25 is now higher 

by approximately 30 violations/year. 

11/15/12
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Exhibit VI-11 Estimates of Corrective Actions

Notes: X-axis begins at Year 4 after rule promulgation, which is the first year of full implementation of the RTCR 

and Alternative option. The annual rates of corrective actions as predicted by the model reach a steady state 

beginning approximately in Year 9, by which time PWSs that are expected to meet the criteria for reduced 

monitoring begin reduced monitoring, and the distribution of PWSs thate monitor monthly, quarterly, and annually 

is assumed to remain relatively constant. All corrective actions performed are in addition to activity under the 1989 

TCR, which does not require corrective actions. Therefore the 1989 TCR is not included in this graph.

Source: RTCR occurrence model output.

 

500

600

700

800

900

1,000

1,100

1,200

1,300

1,400

1,500

1,600

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Corrective Actions (Nondiscounted Values)

Time (Years)

RTCR - Corrective Actions

Alt Option - Corrective Actions

Comment [EPA140]: Correction in 

this exhibit; the Alternative option line 

from Year 9 to Year 25 is now higher 

by approximately 50 corrective 

actions/year. 11/15/12
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Exhibit VI-12 Discounted Estimates of Non-Acute Violations (1989 TCR) and Level 1 

Assessment Triggers (RTCR and Alternative Options) (three percent discount rate)

Notes: X-axis begins at Year 4 after rule promulgation, which is the first year of full implementation of the RTCR 

and Alternative option. The annual rates of non-acute violations (1989 TCR) and Level 1 assessment triggers 

(RTCR and Alternative option) as predicted by the model reach a steady state beginning in approximately Year 9, by 

which time PWSs that are expected to meet the criteria for reduced monitoring begin reduced monitoring, and the 

distribution of PWSs the that monitor monthly, quarterly, and annually is assumed to remain relatively constant. 

Estimates represent the annual number of assessment triggers found by each option and the non-acute violations 

found under the 1989 TCR.

Source: RTCR occurrence model output.

Comment [EPA141]: Correction in 

this exhibit; the Alternative option line 

from Year 9 to Year 25 is now higher 

by approximately 200 triggers/year. 

11/15/12
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Exhibit VI-13 Discounted Estimates of Acute Violations (1989 TCR) and E. coli

Violations (RTCR and Alternative Options) (three percent discount rate)

Notes: X-axis begins at Year 4 after rule promulgation, which is the first year of full implementation of the RTCR 

and Alternative option. The annual rates of acute violations (1989 TCR) and E. coli MCL violations (RTCR and 

Alternative option) as predicted by the model reach steady state in approximately Year 9, by which time PWSs that 

are expected to meet the criteria for reduced monitoring begin reduced monitoring, and the distribution of PWSs 

thate monitor monthly, quarterly, and annually is assumed to remain relatively constant. Estimates represent the 

annual number of acute violations found by each option and the 1989 TCR.

Source: RTCR occurrence model output.

Exhibit VI-14 Discounted Estimates of Corrective Actions (three percent discount rate)

Comment [EPA142]: Correction in 

this exhibit; the Alternative option line 

from Year 9 to Year 25 is now higher 

by approximately 20 violations/year. 

11/15/12

Comment [EPA143]: Correction in 

this exhibit; the Alternative option line 

from Year 9 to Year 25 is now higher 

by approximately 20 corrective 

actions/year. 11/15/12
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Notes: X-axis begins at Year 4 after rule promulgation, which is the first year of full implementation of the RTCR 

and or Alternative option. The annual rates of corrective actions as predicted by the model reach a steady state 

beginning in approximately Year 9, by which time PWSs that are expected to meet the criteria for reduced 

monitoring begin reduced monitoring, and the distribution of PWSs thate monitor monthly, quarterly, and annually 

is assumed to remain relatively constant. All corrective actions performed are in addition to activity under the 1989 

TCR, which does not require corrective actions. Therefore the 1989 TCR is not included in this graph.

Source: RTCR occurrence model output.

3. Nonquantifiable benefits 

a. Potential decreased incidence of endemic illness from fecal contamination, waterborne 

pathogens, and associated outbreaks. As discussed in section VI.E of this preamble, Anticipated 

Benefits of the RTCR, and chapter 2 of the RTCR EA, benefits from the RTCR may include 

avoidance of a full range of health effects from the consumption of fecally contaminated 

drinking water, including the following: acute and chronic illness, endemic and epidemic 
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disease, waterborne disease outbreaks, and death. EPA recognizes that the EPA-approved 

standard methods available for E. coli do not typically identify the presence of the pathogenic E. 

coli strains, such as E. coli O157:H7. Thus, E. coli occurrence, as used in this EA, serves as an 

indication of fecal contamination but not necessarily pathogenic contamination. See also 

discussion in section II.D of this preamble, Public Health Concerns Addressed by the Revised 

Total Coliform Rule.

EPA was unable to quantify the cases of morbidity or mortality avoided because there are 

insufficient data reporting the co-occurrence of fecal indicator E. coli and pathogenic organisms 

in a single water sample, and because the available fecal indicator E. coli data from the Six-Year 

Review 2 dataset were limited to presence-absence data. Instead, EPA estimated changes in total 

coliform and fecal indicator E. coli occurrence (for systems serving 4,100 or fewer people) and 

changes in number of corrective actions (for systems serving greater than 4,100 people) as 

measures of reduced risk. As discussed previously, the assessments and corrective actions 

required under the RTCR will help lead to a decrease in total coliform and E. coli occurrence in 

drinking water. Since fecal contamination can contain waterborne pathogens including bacteria, 

viruses, and parasitic protozoa, in general, a reduction in fecal contamination should also reduce 

the potential risk from all of these other contaminants and the associated primary and secondary 

endemic disease burden, both acute and chronic.

b. Other nonquantifiable benefits. This section describes other nonquantified benefits, 

which include those associated with increased knowledge regarding system operation, 

accelerated maintenance and repair, avoided costs of outbreaks, and reductions in averting 

behavior.

Comment [JL144]: Does this mean 

that exhibits VI-9, 10, 12, and 13 are 

for systems serving less than 4100, 

and exhibits VI-11 and VI-14 are for 

systems serving more than 4100. If 

so, this is not made clear anywhere, 

please clarify.

Comment [EPA145]: Tables 

represent all systems.

JL: This is still not clear. For 

example, in Table VI-14, are these all 

the corrective actions at all systems, or 

only those at systems serving greater 

than 4,100. If the latter, you need to 

clarify in the table, if the former, then 

the highlighted sentence in this para is 

very confusing. Similar confusion 

applies to tables VI-9 through VI-13. 

Please clarify.

Agreed to delete the parentheticals 

7/26
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By requiring PWSs to conduct assessments that meet minimum elements focused on 

identifying sanitary defects in response to triggers for total coliform- or E. coli-positive samples, 

the RTCR increases the likelihood that PWS operators, in particular those of systems triggered to 

conduct assessments and corrective action, will develop further understanding of system 

operations and improve and practice preventive maintenance compared to the 1989 TCR, which 

does not require PWSs to perform assessments and corrective action.

Another non-quantified benefit is that systems may choose corrective actions that also 

address other drinking water contaminants. For example, correcting for a pathway of potential 

contamination into the distribution system can possibly also mitigate a variety of other potential 

contaminants. Due to the lack of data available on the effect of corrective action on 

contamination entering through distribution system pathways, EPA has not quantified such 

potential benefits.

Some systems may see additional nonquantified benefits associated with the acceleration of 

their capital replacement fund investments in response to early identification of impending 

problems with large capital components. Although such capital investment will eventually occur 

in the absence of RTCR requirements, earlier investment may ensure that problems are addressed 

in a preventive manner and may preclude some decrease in protection that might have occurred 

otherwise. At the very least, the increased operator awareness is expected to reduce the 

occurrence of unplanned capital expenditures in any given year. However, because of the 

difficulty of projecting when capital replacements would occur, EPA has not costed this 

acceleration of capital replacement, so there would also be a nonquantified cost of making such 

investments sooner.
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Another major non-health benefit is the avoided costs associated with outbreak response. 

Outbreaks can be very costly for both the PWS and the community in which they occur. 

Avoided outbreak response costs include such costs as issuing public health warnings, boiling 

drinking water and providing alternative supplies, remediation and repair, and testing and 

laboratory costs. Reduced total coliform occurrence resulting from the RTCR may also lead to a 

reduction of costs associated with boil-water orders, which some States require following nonacute violations under the 1989 TCR. Taken together, these expenses can be quite significant. 

For example, an analysis of the economic impacts of a waterborne disease outbreak in 

Walkerton, Ontario (population 5,000) estimated the economic impact (, excluding medically 

related costsestimates of the value of a statistical life for 7seven deaths and intangible costs for 

illness-related suffering), to be over $45.9 millionM in 2007 Canadian dollars (approximately 

$42.8M million 2007 US dollars) (Livernois 2002). Note that some of these costs were 

incurred by individuals and businesses in neighboring communities. The author of the study 

suggested that this was a conservative estimate. 

In addition, the RTCR may also reduce uncertainty regarding drinking water safety, which 

may lead to reduced costs for averting behaviors. Averting behaviors include the use of bottled

water and point-of-use devices. This benefit also includes the reductions in time spent on 

averting behavior such as the time spent obtaining alternative water supplies.

F. Anticipated Costs of the RTCR 

To understand the net impacts of the RTCR on public water systems and States in terms of 

costs, EPA first used available data, information, and best professional judgment to characterize 

how PWSs and States are currently implementing the 1989 TCR. Then, EPA considered the net 

change in costs that results from implementing the RTCR or Alternative options as compared to 

Comment [JL146]: This works out to 

$9,000 per person. Especially if this 

excludes medical costs (and even if it 

didn’t) this is simply not a credible 

estimate. Suggest deleting.

Comment [EPA147]: Documented in 

the report, and does not include 

medical/hospitalizations, 7 deaths. 

Only costs to community 

infrastructure. See references, 

Livernois, J. 2002. The Economic 

Costs of the Walkerton Crisis. The 

Walkerton Inquiry. Commissioned 

Paper 14. Toronto: Ontario Ministry 

of the Attorney General. 62 pp.

JL: I checked this reference and 

numerous categories of medical costs 

are included. The suggested edit 

reflects the costs that were omitted 

according to the authors.

EPA – ok with these edits 
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 165 of 325

the costs of continuing with the 1989 TCR. The objective was to present the net change in costs 

resulting from revisions to the 1989 TCR rather than absolute total costs of implementing the 

1989 TCR as revised by the RTCRs. More detailed information on cost estimates is provided in 

the sections that follow and a complete discussion can be found in chapter 7 of the RTCR EA. A 

detailed discussion of the RTCR requirements is located in section III of this preamble.,

Requirements of the Revised Total Coliform Rule.

1. Total annualized present value costs

To compare cost of compliance activities for the three regulatory scenarios, the year or years 

in which all costs are expended are determined and the costs are then calculated as a net present 

value. For the purposes of this EA, one-time and yearly costs were projected over a 25-year time 

period to allow comparison with other drinking water regulations using the same analysis period. 

For this analysis, the net present values of costs in 2007 dollars are calculated using discount 

rates of three percent and seven percent. These present value costs are then annualized over the 

25-year period using the two discount rates.

Exhibit VI-15 summarizes the comparison of total and net change in annualized present 

value costs of the RTCR and Alternative options relative to the 1989 TCR baseline. A 

continuation of the 1989 TCR will result in no net change in costs. In calculating the 1989 TCR 

baseline, not all activities that PWSs and States are performing under the 1989 TCR were 

quantified (see Exhibit VI-16 of this preamble). Some of these activities are not required under 

the 1989 TCR but PWSs are performing them nonetheless (e.g., corrective actions); or these 

activities are required under the 1989 TCR and PWSs and States will continue to perform them 

under either the RTCR or Alternative option (e.g., revising sample siting plans). Instead of 

determining the absolute costs of performing these activities, EPA instead, estimated the net 

Comment [EPA148]: EPA ok with 

this OMB suggested edit.
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 166 of 325

increase in costs from these activities as a result of implementing either the RTCR or the 

Alternative option. The net change in mean annualized present value national costs of the RTCR 

option relative to the 1989 TCR is estimated to be approximately $14 million (M) using either a 

three percent or seven percent discount rate. The net change in mean annualized present value

national costs for the Alternative option relative to the 1989 TCR are estimated to be 

approximately $28M 30M using a three percent discount rate and $30M 32M using a seven 

percent discount rate. 

Under the RTCR option, public water systems are estimated to incur greater than 90 percent 

of the RTCR’s net annualized present value costs. States are expected to incur the remaining 

costs. 

Exhibit VI-15 Comparison of Total and Net Change from 1989 TCR in 

Annualized Present Value Costs ($Millions, 2007$)

PWSs State Total PWSs State Total

3% Discount Rate 7% Discount Rate

1989 TCR: Baseline 1 185 0.9 186 178 0.9 179 

RTCR: Baseline + Incremental 2 199 1.1 200 192 1.3 193 

RTCR: Net Change 14 0.1 14 14 0.4 14 

RTCR: Percent Change 8% 16% 8% 8% 48% 8%

Alternative option: Baseline + 

Incremental 2 214 1.2 216 209 1.5 210 

Alternative option: Net Change 29 0.3 30 31 0.6 32 

Alternative option: Percent Change 16% 34% 16% 17% 69% 18%

Note: Detail may not add due to independent rounding.

Source: RTCR EA (USEPA 2012a). 1 Does not quantify all 1989 TCR components.

2 For components not quantified for the 1989 TCR, only the net increase in the costs of these components is 

considered for the RTCR and Alternative options (e.g., corrective action costs).

Exhibit VI-16 presents the comparison of total and net change in annualized present value

costs for PWSs and States by rule component. The table shows that routine monitoring and 

corrective action costs are the most significant contributors to the net increase in costs for PWSs 

Comment [EPA149]: The corrected 

Alternative option costs are now 

higher. 

•At a 3% discount rate, the system 

baseline+incremental costs 

increased by $2M, and the net 

change costs increased by $1M. 

•Due to rounding, the state costs in 

this exhibit did not increase, but the 

total net change costs increased by 

$2M dollars. 

•The change in the last row, from 

left to right, is 1, 2, and 1 %.

11/15/12

Comment [JL151]: Calling these 

“present value” is confusing. 

“Annualized” by itself is generally 

used to describe the calculation you 

performed which starts with a present 

value calculation, and then annualizes 

it over some period of years.

Comment [EPA150]: Ok
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 167 of 325

under both the RTCR and Alternative options. For the Alternative option, routine monitoring 

costs are the most significant contributor to the net increase in costs for PWSs. For States, 

revision of sample siting plans contribute most to the cost increase under the RTCR and 

Alternative option. For both PWSs and States, a net decrease in costs associated with PN 

requirements helps to offset the total net cost increase.

Exhibit VI-16 Comparison of Total and Net Change in Annualized Present Value

Costs by Rule Component ($Millions, 2007$) 

PWSs State Total PWSs State Total

3% Discount Rate 7% Discount Rate

Rule Implementation and Annual Administration

1989 TCR – Total - - - - - - 

RTCR – Total 2.77 0.18 2.95 4.00 0.26 4.26 

RTCR – Net Change 2.77 0.18 2.95 4.00 0.26 4.26 

Alternative Option – Total 2.77 0.18 2.95 4.00 0.26 4.26 

Alternative Option – Net Change 2.77 0.18 2.95 4.00 0.26 4.26 

Sample Siting Plan Revision

1989 TCR – Total - - - - - - 

RTCR – Total 0.59 0.42 1.01 0.84 0.59 1.42 

RTCR – Net Change 0.59 0.42 1.01 0.84 0.59 1.42 

Alternative Option – Total 0.59 0.42 1.01 0.84 0.59 1.42 

Alternative Option – Net Change 0.59 0.42 1.01 0.84 0.59 1.42 

Routine Monitoring

1989 TCR – Total 170.59 - 170.59 163.94 - 163.94 

RTCR – Total 174.71 - 174.71 167.74 - 167.74 

RTCR – Net Change 4.12 - 4.12 3.80 - 3.80 

Alternative Option – Total 187.50 - 187.50 182.48 - 182.48 

Alternative Option – Net Change 16.91 - 16.91 18.54 - 18.54 

Additional Routine Monitoring

1989 TCR – Total 3.87 - 3.87 3.72 - 3.72 

RTCR – Total 1.12 - 1.12 1.09 - 1.09 

RTCR – Net Change (2.75) - (2.75) (2.63) - (2.63)

Alternative Option – Total 0.78 - 0.78 0.66 - 0.66 

Alternative Option – Net Change (3.10) - (3.10) (3.06) - (3.06)

Repeat Monitoring

1989 TCR – Total 5.11 - 5.11 4.92 - 4.92 

RTCR – Total 4.88 - 4.88 4.70 - 4.70 

RTCR – Net Change (0.23) - (0.23) (0.22) - (0.22)

Alternative Option – Total 5.66 - 5.66 5.59 - 5.59 

Alternative Option – Net Change 0.54 - 0.54 0.67 - 0.67 

Annual Site Visits

1989 TCR – Total - - - - - - 

RTCR – Total - - - - - - 

RTCR – Net Change - - - - - - 

Alternative Option – Total - - - - - - 

Alternative Option – Net Change - - - - - - 

Level 1 Assessment

Comment [EPA152]: These 

statements were revised due to 

corrections in Alternative option costs. 

11/15/12 

Comment [EPA153]: The corrected 

Alternative option costs are higher, or 

the cost savings are lower, for all rule 

components other than 

implementation/annual administration, 

sample siting plan revision and annual 

site visits.

At a 3% discount rate,

net change costs increased by:

•$1.16M for routine monitoring

•$0.09M for repeat monitoring

•$0.02M for PWSs and $0.01 for 

states for L1 assessments

•$0.03M for PWSs and $0.01 for 

states for L2 assessments

•$0.15M for PWSs for corrective 

actions based on L1 assessments

•$0.13 for PWSs for corrective 

actions based on L2 assessments

and

net cost savings decreased by

•$0.09M for add’l routine 

monitoring

•$0.01M for PN

11/15/12
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 168 of 325

1989 TCR – Total 1.13 0.21 1.34 1.08 0.20 1.29 

RTCR – Total 1.63 0.20 1.84 1.57 0.20 1.77 

RTCR – Net Change 0.51 (0.01) 0.50 0.49 (0.01) 0.48 

Alternative Option – Total 1.76 0.23 1.99 1.72 0.23 1.94 

Alternative Option – Net Change 0.63 0.02 0.65 0.63 0.02 0.65 

Level 2 Assessment

1989 TCR – Total 0.70 0.26 0.96 0.68 0.25 0.92 

RTCR – Total 0.90 0.19 1.08 0.88 0.18 1.06 

RTCR – Net Change 0.20 (0.07) 0.12 0.20 (0.07) 0.13 

Alternative Option – Total 1.26 0.29 1.55 1.30 0.31 1.61 

Alternative Option – Net Change 0.55 0.03 0.58 0.62 0.06 0.68 

Corrective Actions Based on Level 1 Assessments

1989 TCR – Total - - - - - - 

RTCR – Total 9.62 0.01 9.63 8.14 0.01 8.15 

RTCR – Net Change 9.62 0.01 9.63 8.14 0.01 8.15 

Alternative Option – Total 10.01 0.01 10.02 8.52 0.01 8.53 

Alternative Option – Net Change 10.01 0.01 10.02 8.52 0.01 8.53 

Corrective Actions Based on Level 2 Assessments

1989 TCR – Total - - - - - - 

RTCR – Total 2.82 0.00 2.82 2.49 0.00 2.49 

RTCR – Net Change 2.82 0.00 2.82 2.49 0.00 2.49 

Alternative Option – Total 3.78 0.01 3.79 3.57 0.01 3.58 

Alternative Option – Net Change 3.78 0.01 3.79 3.57 0.01 3.58 

Public Notification

1989 TCR – Total 3.75 0.44 4.19 3.60 0.42 4.02 

RTCR – Total 0.26 0.06 0.32 0.25 0.06 0.31 

RTCR – Net Change (3.49) (0.38) (3.86) (3.35) (0.36) (3.71)

Alternative Option – Total 0.35 0.08 0.43 0.35 0.08 0.44 

Alternative Option – Net Change (3.40) (0.36) (3.76) (3.25) (0.34) (3.58)

Note: Detail may not add due to independent rounding.

Assumes a certain level of assessment activity already occurs under the 1989 TCR, as discussed in Chapter 7 of the 

RTCR EA (USEPA 2012a).

Not all 1989 TCR components are quantified. For components not quantified for the 1989 TCR, only the net 

increase in the costs of these components is considered for the RTCR and Alternative options (e.g., corrective action 

costs).

Source: RTCR EA (USEPA 2012a)

 

2. PWS costs

Like the 1989 TCR, the RTCR applies to all PWSs. Exhibit VI-17 presents the total and net 

change in annualized costs to PWSs by size and type for the three regulatory options. No net 

change in costs will result from a continuation of the 1989 TCR. Among PWSs serving 4,100 or 

fewer people, looking at the three percent discount rate, the largest increase in aggregate net 

costs is incurred by the TNCWSs serving 100 or fewer people under either the RTCR ($5.3M) or 

Alternative option ($13.614.7M) because of the large number of systems. On a per system basis, Comment [EPA154]: Revised 

11/15/12
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 169 of 325

this translates to a net annualized present value increase of approximately $86 per system under 

the RTCR and $218 240 per system under the Alternative option for the TNCWSs serving 100 or 

fewer people. As described in section VII.C of this preamble, Regulatory Flexibility Act (RFA), 

none of the small TNCWSs are estimated to have costs that are greater than or equal to three 

percent of their revenue and only 61 small systems (0.04%) are estimated to have costs greater 

than or equal to one percent of their revenue.

The total net change in national annualized present value costs for all PWSs serving greater 

than 4,100 people (approximately $5.6M using three percent discount rate) is the same under the 

RTCR and Alternative option. This is expected because the provisions for PWSs serving greater 

than 4,100 are the same under the RTCR and the Alternativeeither option. Monitoring 

requirements for PWSs serving greater than 4,100 people remain essentially unchanged under 

either the RTCR or Alternative option. The observed overall net increase in costs for PWSs 

serving greater than 4,100 people is driven primarily by the requirements to conduct assessments 

and to correct any sanitary defects that are found.

Exhibit VI-17 Total and Net Change in Annualized Costs to PWSs by PWS Size 

and Type ($Millions, 2007$)

PWS Size 

(Population 

Served)

3% Discount Rate 7% Discount Rate

1989 

TCR 

Total

RTCR 

Total

RTCR 

Net

Alternative 

Option 

Total

Alternative 

Option 

Net

1989 

TCR 

Total

RTCR 

Total

RTCR 

Net

Alternative 

Option 

Total

Alternative 

Option 

Net

A B C=B-A D E=D-A F G H=G-F I J=I-F

Community Water Systems (CWSs)

≤100 7.4 7.5 0.1 7.6 0.2 7.1 7.3 0.2 7.5 0.3 

101-500 9.0 9.4 0.4 9.5 0.5 8.6 9.1 0.5 9.2 0.6 

501-1,000 3.7 3.8 0.0 3.8 0.1 3.6 3.7 0.1 3.7 0.1 

1,001-4,100 13.2 13.6 0.4 13.6 0.4 12.7 13.1 0.4 13.1 0.4 

4,101-33K 42.4 44.8 2.4 44.8 2.4 40.7 42.8 2.1 42.8 2.1 

33,001-96K 34.9 36.4 1.5 36.4 1.5 33.5 34.8 1.3 34.8 1.3 

96,001-500K 34.7 36.2 1.5 36.2 1.5 33.4 34.6 1.2 34.6 1.2 

500,001-1M 6.5 6.7 0.2 6.7 0.2 6.2 6.4 0.1 6.4 0.1 

>1M 5.6 5.6 (0.0) 5.6 (0.0) 5.3 5.3 (0.0) 5.3 (0.0)

Total 157.4 163.9 6.5 164.1 6.7 151.3 157.2 5.9 157.5 6.2 

Nontransient Noncommunity Water Systems (NTNCWSs)

≤100 2.6 2.7 0.1 3.7 1.1 2.5 2.7 0.2 3.8 1.4 

101-500 1.9 2.0 0.1 2.8 0.9 1.8 2.0 0.2 2.9 1.1 

501-1,000 0.6 0.6 0.1 0.9 0.3 0.6 0.6 0.1 0.9 0.3 

1,001-4,100 1.2 1.3 0.1 1.3 0.1 1.1 1.2 0.1 1.2 0.1 

4,101-33K 0.4 0.5 0.1 0.5 0.1 0.4 0.5 0.0 0.5 0.0 

Comment [EPA155]: Revised 

11/15/12

Comment [JL156]: What about one 

percent? This is the other standard 

threshold used to evaluate these 

effects.

Comment [EPA157]: RFA section 

below, on page 211 says this: “We 

have determined that only 61 of 

150,672 small systems (0.04%) will 

experience an impact of more than 1% 

of revenues.” Necessary to repeat that 

here? In the GWR we did not include 

text to discuss the difference in costs 

for different system sizes as we do 

here. 

Comment [EPA158]: EPA ok with 

this edit as suggested by OMB

Comment [EPA159]: The corrected 

total and net change Alternative 

option costs are higher (totaled across 

all system sizes) for NTNCWSs and 

TNCWSs. The costs for CWSs were 

not affected. At a 3% discount rate, 

Alternative option total costs 

increased by:

•$0.1M for NTNCWSs

•$1.6M for TNCWSs

Alternative option net costs increased 

by:

•$0.2 for NTNCWSs

•$1.5 for TNCWSs
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 170 of 325

33,001-96K 0.1 0.1 0.0 0.1 0.0 0.1 0.1 0.0 0.1 0.0 

96,001-500K 0.1 0.1 (0.0) 0.1 (0.0) 0.1 0.1 (0.0) 0.1 (0.0)

500,001-1M 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 

>1M 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 

Total 6.9 7.3 0.4 9.3 2.5 6.6 7.2 0.6 9.6 3.0 

Transient Noncommunity Water Systems (TNCWSs)

≤100 13.4 18.7 5.3 28.1 14.7 12.8 18.2 5.3 28.9 16.1 

101-500 4.9 6.5 1.6 9.5 4.7 4.7 6.3 1.6 9.8 5.1 

501-1,000 0.6 0.8 0.2 1.2 0.5 0.6 0.8 0.2 1.2 0.6 

1,001-4,100 0.9 1.0 0.1 1.0 0.1 0.9 1.0 0.1 1.0 0.1 

4,101-33K 0.4 0.5 0.1 0.5 0.1 0.4 0.5 0.0 0.5 0.0 

33,001-96K 0.1 0.1 (0.0) 0.1 (0.0) 0.1 0.1 (0.0) 0.1 (0.0)

96,001-500K 0.1 0.1 (0.0) 0.1 (0.0) 0.1 0.1 (0.0) 0.1 (0.0)

500,001-1M 0.2 0.2 (0.0) 0.2 (0.0) 0.2 0.2 (0.0) 0.2 (0.0)

>1M 0.3 0.3 0.0 0.3 0.0 0.3 0.3 0.0 0.3 0.0 

Total 20.9 28.1 7.3 41.0 20.1 20.1 27.3 7.3 42.0 21.9 

Grand Total 185.2 199.3 14.2 214.4 29.3 177.9 191.7 13.8 209.0 31.1 

Note: Detail may not add due to independent rounding. Because only the incremental costs of some rule 

components are considered as part of the cost analysis, references to “total” costs in this exhibit do not refer to 

complete costs for regulatory implementation but only to specific costs considered to calculate net change in costs.

Source: RTCR cost model.

The following subsections discuss the different components of the costs to PWSs: rule 

implementation and annual administration, sample siting plan revision, monitoring, annual site 

visits, assessments, corrective actions, and public notification.

a. Rule implementation and annual administration. Under the RTCR and Alternative 

options, all PWSs subject to the RTCR incur one-time costs that include time for staff to read the 

RTCR, become familiar with its provisions, and to train employees on rule requirements. No 

additional implementation burden or costs will be incurred by PWSs if the 1989 TCR option is 

maintained. Under the RTCR and Alternative options, all PWSs subject to the RTCR perform 

additional or transitional implementation activities. Based on previous experience with rule 

implementation, EPA estimated that PWSs require a total of four hours to read and understand 

the rule, and a total of eight hours to plan and assign appropriate personnel and resources to carry 

out rule activities. EPA estimated a net increase in national annualized cost estimates incurred 

by PWSs for rule implementation and annual administration of $2.77M (three percent discount 

rate) and $4.00M (seven percent discount rate) under either the RTCR or the Alternative option. 

The annualized net present value total and net change cost estimates for PWSs for rule 
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 171 of 325

implementation and annual administration under the 1989 TCR, RTCR, and Alternative options

are presented in Exhibit VI-16 of this preamble.

b. Sample siting plan revision. Under the RTCR and Alternative options, all PWSs subject 

to the RTCR incur one-time costs to revise existing sample siting plans to identify sampling 

locations and collection schedules that are representative of water throughout the distribution 

system. Under the 1989 TCR, no additional burden or costs are expected to be incurred by 

PWSs to revise sample siting plans, as these PWSs are already collecting total coliform samples 

in accordance with a written sample siting plan. Based on previous experience, EPA estimated 

that PWSs require two to eight hours to revise their sample siting plan, depending on PWS size. 

EPA estimated a net increase in national annualized cost estimates incurred by PWSs for revising 

sample siting plans of $0.59M (three percent discount rate) and $0.84M (seven percent discount 

rate) under either the RTCR or the Alternative option. The annualized net present value total and 

net change cost estimates for PWSs to revise their sample siting plan under the 1989 TCR, 

RTCR, and Alternative options are presented in Exhibit VI-16 of this preamble.

c. Monitoring. Monitoring costs for PWSs are calculated by multiplying the total numbers 

of routine, additional routine, and repeat samples required under the 1989 TCR, RTCR, and 

Alternative options by the monitoring costs per sample. Under the RTCR, the increased 

stringency to qualify for reduced monitoring results in more routine samples being taken over 

time (fewer PWSs are on reduced monitoring) compared to the 1989 TCR. For the Alternative 

option, this effect is combined with the requirement that all PWSs start the implementation 

period on monthly monitoring. The Alternative option also prohibits annual monitoring, 

resulting in a greater increase in the number of routine samples compared to the RTCR option. 
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 172 of 325

Costs for routine monitoring under the RTCR and Alternative option are higher than routine 

monitoring costs under the 1989 TCR.

The overall reductions in the numbers of additional routine samples required under the 

RTCR and Alternative option result in lower costs for additional routine monitoring when 

compared to the 1989 TCR. Under the RTCR and Alternative options, additional routine 

monitoring is no longer required for systems that monitor at least monthly, and when additional 

routine monitoring is required, the number of samples required is reduced from five to three. 

Cost reductions are greater under the Alternative option than under the RTCR because under the 

Alternative option all PWSs start on monthly monitoring and are not required to take additional 

routine samples during that period. 

Costs for repeat sampling are also lower under the RTCR and Alternative options. Under the 

1989 TCR, PWSs serving 1,000 or fewer people take four repeat samples, at and within five 

service connections upstream and downstream of the initial total coliform positive occurrence 

location, over the course of 24 hours following the event. Under the RTCR and Alternative 

options, PWSs serving 1,000 or fewer people will need to take only three repeat samples, and 

they have greater flexibility about where to take them, consistent with the system sample siting 

plan that is developed in accordance with RTCR requirements and subject to review and revision 

by the State. The number of repeat samples required for PWSs serving more than 1,000 people 

is the same under the 1989 TCR and the RTCR and Alternative options, although these systems 

also have greater flexibility in sample location.

Exhibit VI-18 summarizes the cumulative number of samples taken by PWS size and 

category for routine, additional, and repeat monitoring under the 1989 TCR, RTCR, and 

Alternative option over the entire 25-year period of analysis. Under the 1989 TCR option, 
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 173 of 325

approximately 82.1 millionM samples are taken over the 25-year period of analysis compared to 

approximately 82.2 millionM samples under the RTCR option and approximately 87.287.9

millionM samples under the Alternative option (less than 10 percent more than 1989 TCR 

option). Appendix A of the RTCR EA presents additional information on the number of samples 

taken each year during the analysis period.

Exhibit VI-18 Cumulative Number of Samples over 25-Year Period of Analysis for 

Baseline (1989 TCR) and Regulatory Alternatives (RTCR and Alternative option) 

PWS Size 

(Population 

Served)

1989 TCR RTCR Alternative

Routine 

Monitoring 

Samples

Additional 

Routine 

Monitoring 

Samples

Repeat 

Monitoring 

Samples

Routine 

Monitoring 

Samples

Additional 

Routine 

Monitoring 

Samples

Repeat 

Monitoring 

Samples

Routine 

Monitoring 

Samples

Additional 

Routine 

Monitoring 

Samples

Repeat 

Monitoring 

Samples

A B C D E F G H I

Community Water Systems (CWSs) – Surface Water

≤100 304,247 23,167 18,698 308,880 - 13,764 308,880 - 13,764 

101-500 562,198 27,009 21,684 567,600 - 15,660 567,600 - 15,660 

501-1,000 306,605 15,334 12,299 309,672 - 8,708 309,672 - 8,708 

1,001-4,100 1,921,237 55,132 33,729 1,951,224 - 33,326 1,951,224 - 33,326 

4,101-33K 10,636,296 - 186,729 10,636,296 - 181,661 10,636,296 - 181,661 

33,001-96K 11,058,960 - 194,149 11,058,960 - 188,880 11,058,960 - 188,880 

96,001-

500K 10,190,400 - 178,901 10,190,400 - 174,046 10,190,400 - 174,046 

500,001-1M 2,019,600 - 35,456 2,019,600 - 34,493 2,019,600 - 34,493 

>1M 1,686,960 - 29,616 1,686,960 - 28,812 1,686,960 - 28,812 

Total 38,686,502 120,642 711,259 38,729,592 - 679,350 38,729,592 - 679,350 

Community Water Systems (CWSs) -– Ground Water

≤100 2,815,951 286,073 194,462 2,870,075 8,760 156,897 2,908,469 7,545 158,439 

101-500 3,344,578 243,895 171,252 3,391,200 6,127 136,906 3,428,876 5,264 137,959 

501-1,000 1,072,202 70,803 51,673 1,085,730 1,844 39,659 1,098,488 1,616 39,580 

1,001-4,100 3,997,293 160,710 100,618 4,079,328 - 96,939 4,079,328 - 96,939 

4,101-33K 9,145,224 - 230,201 9,145,224 - 217,321 9,145,224 - 217,321 

33,001-96K 4,884,000 - 122,938 4,884,000 - 116,060 4,884,000 - 116,060 

96,001-

500K 1,945,680 - 48,976 1,945,680 - 46,236 1,945,680 - 46,236 

500,001-1M

 253,440 - 

 

6,380 253,440 - 6,023 253,440 - 6,023 

>1M

 269,280 - 

 

6,778 269,280 - 6,399 269,280 - 6,399 

Total 27,727,648 761,481 933,279 27,923,956 16,731 822,439 28,012,784 14,425 824,956 

Nontransient Noncommunity Water Systems (NTNCWSs) – Surface Water

≤100

 65,018 

 

4,910 

 

3,991 66,000 - 3,040 66,000 - 3,040 

101-500

 66,045 

 

3,735 

 

3,011 66,792 - 2,169 66,792 - 2,169 

501-1,000

 22,976 

 

1,278 

 

1,029 23,232 - 756 23,232 - 756 

1,001-4,100

 41,759 

 

2,142 

 

1,348 42,768 - 1,228 42,768 - 1,228 

4,101-33K

 50,424 - 

 

1,628 50,424 - 1,448 50,424 - 1,448 

33,001-96K

 34,320 - 

 

1,108 34,320 - 985 34,320 - 985 

96,001-

500K 31,680 - 

 

1,023 31,680 - 910 31,680 - 910 

500,001-1M - - - - - - - - - 

>1M - - - - - - - - - 

Total 312,223 12,065 13,138 315,216 - 10,536 315,216 - 10,536 

Nontransient Noncommunity Water Systems (NTNCWSs) – Ground Water

≤100 971,538 128,775 84,992 932,025 48,142 68,123 1,314,175 36,965 91,416 

101-500 725,785 66,525 43,597 678,688 25,630 35,860 976,627 19,382 48,269 

501-1,000 190,649 16,037 10,680 180,145 6,166 8,601 249,760 4,802 11,817 

1,001-4,100 460,470 28,214 17,790 473,352 - 15,887 473,352 - 15,887 

Comment [EPA160]: Corrected 

11/15/12

Comment [EPA161]: The corrected 

number of samples taken under the 

Alternative option are now higher for 

ground water NTNCWSs and 

TNCWSs. The number of samples 

taken for surface water systems or for 

any CWSs were not affected.

The number of samples taken under 

the Alternative option increased by:

NTNCWSs—Ground Water

Routine: 60,101

Add’l routine: 3,780

Repeat: 3,185

TNCWSs—Ground Water

Routine: 567,723

Add’l routine: 58,441

Repeat: 59,325

11/15/12
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4,101-33K

 153,648 - 

 

5,936 153,648 - 5,157 153,648 - 5,157 

33,001-96K

 23,760 - 

 

918 23,760 - 797 23,760 - 797 

96,001-

500K - - - - - - - - - 

500,001-1M - - - - - - - - - 

>1M - - - - - - - - - 

Total 2,525,850 239,551 163,913 2,441,617 79,938 134,426 3,191,322 61,149 173,343 

Transient Noncommunity Water Systems (TNCWSs) – Surface Water

≤100 345,401 40,475 33,065 353,496 - 23,122 353,496 - 23,122 

101-500 128,156 15,261 12,454 131,208 - 8,192 131,208 - 8,192 

501-1,000

 22,691 

 

2,704 

 

2,207 23,232 - 1,533 23,232 - 1,533 

1,001-4,100

 40,151 

 

4,155 

 

2,707 42,240 - 2,312 42,240 - 2,312 

4,101-33K 40,656 - - 40,656 - 2,225 40,656 - 2,225 

33,001-96K - - - - - - - - - 

96,001-

500K - - - - - - - - - 

500,001-1M - - - - - - - - - 

>1M 102,960 - - 102,960 - 5,636 102,960 - 5,636 

Total 680,015 62,596 50,434 693,792 - 43,020 693,792 - 43,020 

Transient Noncommunity Water Systems (TNCWSs) – Ground Water

≤100 4,493,808 905,554 600,315 6,076,163 446,166 631,105 9,524,123 333,524 912,589 

101-500 1,614,924 316,238 210,714 1,940,946 135,822 194,697 3,021,771 104,732 282,740 

501-1,000 177,264 32,730 22,064 206,130 14,078 20,078 304,534 10,412 27,932 

1,001-4,100 335,283 29,957 19,113 348,480 - 16,027 348,480 - 16,027 

4,101-33K

 156,288 - 

 

8,909 156,288 - 7,188 156,288 - 7,188 

33,001-96K

 34,320 - 

 

1,956 34,320 - 1,578 34,320 - 1,578 

96,001-

500K 26,400 - 

 

1,505 26,400 - 1,214 26,400 - 1,214 

500,001-1M

 63,360 - 

 

3,612 63,360 - 2,914 63,360 - 2,914 

>1M - - - - - - - - - 

Total 6,901,647 1,284,478 868,188 8,852,088 596,065 874,801 13,479,275 448,667 1,252,181 

Grand 

Total 76,833,885 2,480,814 2,740,210 78,956,260 692,734 2,564,572 84,421,981 524,241 2,983,387 

Note: (B), (E), (H) For modeling purposed, additional routine sample counts include regular routine samples taken in the same month.

Source: Appendix A of the RTCR EA (USEPA 2012a) – Total PWS Counts (A.1z, A.2z, A.3z).

The annualized net present value total and net change cost estimates for PWSs to perform 

monitoring under the 1989 TCR, RTCR, and Alternative options are presented in Exhibit VI-19. 

EPA estimated a net increase in national annualized cost estimates incurred by PWSs for 

monitoring of $1.14M (three percent discount rate) and $0.95M (seven percent discount rate) 

under the RTCR and a net increase of $13.0214.36M (three percent discount rate) and 

$15.0116.15M (seven percent discount rate) under the Alternative option. See also Exhibit VI16 of this preamble for a breakdown on the costs of monitoring (i.e., routine, additional routine, 

repeat).

Exhibit VI-19 Annualized National PWS Monitoring Cost Estimates ($Millions, 2007$)

3% discount rate 7% discount rate

Comment [EPA162]: Corrected 

11/15/12

Comment [EPA163]: Corrected 

11/15/12

Comment [EPA164]: The corrected 

total and net change Alternative 

option costs are now higher. 

At a 3% discount rate, the total and 

net change costs increased by $1.36M, 

and the percent change increased by 

0.74%.

11/15/12
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1989 TCR - Total $ 179.57 $ 172.57 

RTCR – Total $ 180.71 $ 173.52 

RTCR - Net Change $ 1.14 $ 0.95 

RTCR - Percent Change 0.63% 0.55%

Alternative option – Total $ 193.93 $ 188.72 

Alternative option - Net Change $ 14.36 $ 16.15 

Alternative option - Percent Change 7.99% 9.36%

Note: Detail may not add due to independent rounding.

Source: RTCR EA (USEPA 2012a)

The overall estimated increase in monitoring costs seen under the RTCR is driven by 

increases in routine monitoring due to stricter requirements to qualify for reduced monitoring. 

However, this is mostly offset by reductions in additional routine and repeat monitoring. For the 

Alternative option, the requirement for all PWSs to sample on a monthly basis at the beginning 

of rule implementation results in a much larger cost differential that is only partially offset by 

reduced costs from reductions in additional routine monitoring requirements.

d. Annual site visits. Under the RTCR, any PWS on an annual monitoring schedule is 

required to also have an annual site visit conducted by the State or State-designated third party. 

A voluntary Level 2 site assessment can also satisfy the annual site visit requirement. For years 

in which the State performs a sanitary survey (at least every five years for NCWSs and three 

years for CWSs), a sanitary survey performed during the same year can also be used to satisfy 

this requirement. Although similar site visits are not currently required under the 1989 TCR, 

discussions with States during the TCRDSAC proceedings revealed that some do, in fact, 

conduct such site visits for PWSs on annual monitoring schedules. Because of the high cost for 

an annual site visit by a State, for this analysis EPA assumed that no States choose to conduct 

annual site visits unless they already do so under the 1989 TCR. Therefore, for overall costing 

purposes, no net change in PWS or State costs are assumed for annual monitoring site visits 

under the RTCR option or Alternative option.
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e. Assessments. Annualized cost estimates for Level 1 and Level 2 assessments under the 

1989 TCR, RTCR, and Alternative options are calculated in the RTCR EA by multiplying the 

number of assessments estimated by the predictive modeling (summarized in Exhibit 7.13 of the 

EA) by the unit costs (summarized in Exhibits 7-11 and 7-12 of the EA). Appendix A of the 

RTCR EA provides a detailed breakout of the number of Level 1 and Level 2 assessments 

estimated by the occurrence model. EPA estimated a net increase in national annualized cost 

estimates incurred by PWSs for conducting assessment of $0.70M (three percent discount rate) 

and $0.69M (seven percent discount rate) under the RTCR and a net increase of $1.121.18M 

(three percent discount rate) and $1.201.25M (seven percent discount rate) under the Alternative 

option. Annualized cost estimates are presented in Exhibit VI-16 of this preamble.

Under the RTCR, all PWSs are required to conduct assessments of their systems when they 

exceed Level 1 or Level 2 treatment technique triggers. While PWSs are not required to conduct 

assessments under the 1989 TCR, some PWSs do currently engage in assessment activity (which 

may or may not meet the RTCR criteria) following non-acute and acute MCL violations. EPA 

estimates both the costs to PWSs to conduct assessments under the RTCR as well as the level of 

effort that PWSs already put toward assessment activities under the 1989 TCR. These estimates 

are based on the work of the stakeholders in the Technical Work Group (TWG) during the 

proceedings of the TCRDSAC. These estimates allowed EPA to determine the average net costs 

to conduct assessments under the RTCR. EPA assumes that the numbers of non-acute and acute 

MCL violations would remain steady under a continuation of the 1989 TCR based on the review 

of SDWIS/FED violation data. Under the RTCR, EPA assumes that the numbers of assessments

triggers decreases over time from the steady state level seen estimate based on under the 1989 

Comment [EPA165]: Corrected 

11/15/12
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TCR over time to a new steady state level, as a resultfunction of reduced fecal indicator 

occurrence associated with the beneficial effects of requiring assessments and corrective action.

The overall number of assessments is larger under the Alternative option compared to the 

RTCR option. This is a result of the initial monthly monitoring requirements for all PWSs under 

the Alternative option. The modeling results indicate that a greater number of samples early in 

the implementation period results in more positive samples and associated assessments despite 

the predicted long term reductions in occurrence as informed by the assumptions. This increase 

in total assessments performed, combined with the higher unit cost of performing assessments 

compared to existing practices under the 1989 TCR, results in a higher net cost increase for the 

Alternative option than under the RTCR. The total net increase in cost for the Alternative option 

is estimated to be nearly twice that of the RTCR option. See Exhibit 7.15 of the RTCR EA.

f. Corrective actions. Under the RTCR and Alternative options, all PWSs are required to 

correct sanitary defects found through the performance of Level 1 or Level 2 assessments. For 

modeling purposes, EPA estimated the net change in the number of corrective actions performed 

under the RTCR and Alternative options. For GWSground water systems, EPA assumed that 

any corrective actions based on a positive source water sample are accounted for under the GWR 

and not under the RTCR. Based on discussions with State representatives, EPA assumed that an 

additional 10 percent of corrective actions will be performed as a result of the assessment and 

corrective action requirements of the RTCR, representing the net increase of the RTCR over the 

1989 TCR. 

To estimate the costs incurred for the correction of sanitary defects, EPA assumed the 

percent distribution of PWSs that perform different types of corrective actions as presented in the 

compliance forecast shown in Exhibit VI-20 (i.e., distribution of the additional 10 percent of 

Comment [JL166]: I assume you 

mean the number of triggers (acute 

and non-acute violations), not 

assessments. Since assessments are 

not required under the TCR, even 

though some are done voluntarily or 

in response to state requirements, one 

would still expect an increase in 

assessments under the RTCR, since 

they will now be required. Please 

clarify.

Comment [EPA167]: Edits were 

made to address comment. Number of 

assessment triggers will go down once 

RTCR is implemented because the 

assessment and corrective action 

requirements of RTCR will result in 

improved system status and operation 

over time and a corresponding 

reduction in occurrence.
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 178 of 325

corrective actions) based on best professional judgment and stakeholder input. The compliance 

forecast presented in this section was informed by discussions of the TCRDSAC Technical Work 

Group and focuses on broad categories of types of corrective actions anticipated. EPA used best 

professional judgment and stakeholder input to make simplifying assumptions on the distribution 

of these categories that are implemented by different systems based on size and type of system. 

For each of the categories listed, a PWS is assumed to take a specific action that falls under that 

general category. Detailed compliance forecasts showing the specific corrective actions used in 

the cost analysis are provided in Appendix D of the RTCR EA, along with summary tables of the 

unit costs used in the analysis. Each corrective action in the detailed compliance forecast is also 

assigned a representative unit cost. Detailed descriptions of the derivation of unit costs are 

provided in Exhibits 5-1 through 5-47 of the Technology and Cost Document for the Revised 

Total Coliform Rule (USEPA 2012b). 

Exhibit VI-20 Compliance Forecast for Corrective Actions based on Level 1 and Level 2 

Assessments

PWS Size 

(Population 

Served)

PWS 

Flushin

g

Sampler 

Training

Replace/Repair 

of Distribution 

System 

Components

Maintenance 

of Adequate 

Pressure

Maintenanc

e of 

Appropriate 

Hydraulic 

Residence 

Time

Storage 

Facility 

Maintenanc

e

Booster 

Disinfectio

n

Crossconnection 

Control 

and 

Backflow 

Preventio

n

Addition 

or 

Upgrade 

of Online 

Monitorin

g and 

Control

Addition 

of Security 

Measures

Development 

and 

Implementation 

of an Operations 

Plan

A B C D E F G H I J K

Level 1 Compliance Forecast

≤100 39% 15% 12% 9% 8% 6% 4% 1% 3% 1% 2%

101-500 39% 15% 12% 9% 8% 6% 4% 1% 3% 1% 2%

501-1,000 39% 15% 12% 9% 8% 6% 4% 1% 3% 1% 2%

1,001-4,100 39% 15% 12% 9% 8% 6% 4% 1% 3% 1% 2%

4,101-33K 39% 15% 12% 9% 8% 6% 4% 1% 3% 1% 2%

33,001-96K 39% 15% 12% 9% 8% 6% 4% 1% 3% 1% 2%

96,001-500K 39% 15% 12% 9% 8% 6% 4% 1% 3% 1% 2%

500,001-1M 39% 15% 12% 9% 8% 6% 4% 1% 3% 1% 2%

>1M 39% 15% 12% 9% 8% 6% 4% 1% 3% 1% 2%

Level 2 Compliance Forecast

≤100 15% 4% 18% 15% 15% 11% 8% 2% 6% 2% 4%

101-500 15% 4% 18% 15% 15% 11% 8% 2% 6% 2% 4%

501-1,000 15% 4% 18% 15% 15% 11% 8% 2% 6% 2% 4%

1,001-4,100 15% 4% 18% 15% 15% 11% 8% 2% 6% 2% 4%

4,101-33K 15% 4% 18% 15% 15% 11% 8% 2% 6% 2% 4%

33,001-96K 15% 4% 18% 15% 15% 11% 8% 2% 6% 2% 4%

96,001-500K 15% 4% 18% 15% 15% 11% 8% 2% 6% 2% 4%

500,001-1M 15% 4% 18% 15% 15% 11% 8% 2% 6% 2% 4%

>1M 15% 4% 18% 15% 15% 11% 8% 2% 6% 2% 4%

Source: (A) – (K) Percent of PWSs performing corrective actions based on Level 1 and Level 2 assessments reflect 

EPA estimates.

Level 1 assessments generally are less involved than Level 2 assessments and may result in 

finding less complex problems. As shown in the compliance forecast in Exhibit VI-20, EPA 
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estimated that corrective actions found through Level 1 assessments result in corrective actions 

that focus more on transient solutions or training (columns A and B) than on permanent fixes to 

the PWS. However, in the case of flushing, EPA assumed that in a majority of instances, PWSs 

implement a regular flushing program as opposed to a single flushing, based on EPA and 

stakeholder best professional judgment. 

Corrective actions taken as a result of Level 2 assessments are expected to find a higher 

proportion of structural/technical issues (columns C-K) resulting in material fixes to the PWSs 

and distribution system. Consistent with the discussions of the TCRDSAC regarding major 

structural fixes or replacements, EPA did not include these major costs in the analysis. 

Distribution system appurtenances such as storage tanks and water mains generally have a useful 

life that is accounted for in water system capital planning. The assessments conducted in 

response to RTCR triggers could identify when that useful life has ended but are not solely 

responsible for the need to correct the defect. In addition, EPA ran two sensitivity analyses to 

assess the potential impacts of different distributions within the compliance forecast. Results of 

the sensitivity analyses are presented in Exhibit VI-21, which indicates that the low bound 

estimates of annualized net change in costs at three percent discount rate are approximately $3M 

for the RTCR option and $15M 17M for the Alternative option, and the high bound estimates are 

approximately $25M for the RTCR option and $40M 43M for the Alternative option. Varying 

the assumptions about the percentage of corrective actions identified and the effectiveness of 

those actions had less than a linear effect on outcomes, and the RTCR option continues to be less 

costly than the Alternative option under all scenarios modeled.

Exhibit VI-21 Sensitivity Analysis – Annualized Net Change in Costs Based on Changes in 

Compliance Forecast ($Millions, 2007$)

PWSs State Total PWSs State Total

3% Discount Rate 7% Discount Rate

Comment [JL169]: This is a bit 

troubling. What costs did you include

for Level 2 corrective actions? Were 

they on average higher or lower than 

for level 1 corrective actions? What 

exactly did the TCRDSAC say that 

supported not costing these responses?

What did commenters say about this?

Comment [EPA168]: Level 2 

corrective action costs were on 

average higher – see section 7 of the 

EA. Corrective actions requiring 

more capital expense (replacement of 

lines, installation of appurtenances) 

were assumed to be done more 

frequently as a result of a Level 2 

assessment; less costly items like 

flushing and sampler training were 

assumed to be done more frequently 

as a result of a Level 1.

The text essentially represents that 

expressed by the TCRDSAC. This 

issue was also raised by the SAB to 

whom we gave the same answer, and 

they supported our EA effort in 

general.

Comments on this generally agreed 

that these costs do not need to be 

included in the analysis (AWWA, 

ASDWA and others). Others indicated ...

Comment [EPA170]: Corrected 

Alternative option costs are higher for 

all three sets of costs (Net Change, 

Low Bound Net Change, High Bound 

Net Change).

At a 3% discount rate, the costs 

increased by:

•Net change, PWSs: $1.69M

•Net change, States: $0.02M

•Low bound, PWSs: $1.44M

•Low bound, States: $0.02M

•High bound, PWSs: $2.25M

•High bound, States: $0.02M

11/15/12 ...
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 180 of 325

RTCR Net Change 14.15 0.15 14.30 13.75 0.42 14.17 

RTCR Low Bound Net Change 2.61 0.15 2.75 3.91 0.42 4.33 

RTCR High Bound Net Change 25.10 0.15 25.25 23.63 0.42 24.05 

Alternative Option Net Change 29.29 0.31 29.60 31.09 0.61 31.69 

Alternative Option Low Bound Net Change 16.54 0.31 16.84 19.93 0.61 20.54 

Alternative Option High Bound Net Change 42.68 0.31 42.99 43.63 0.61 44.24

Note: Detail may not add due to independent rounding.

Source: RTCR cost model, described in chapter 7 of the RTCR EA (USEPA 2012a).

As indicated in the more detailed analysis presented in chapter 7 of the RTCR EA, PWSs 

also incur reporting and recordkeeping burden to notify the State upon completion of each 

corrective action. PWSs may also consult with the State or with outside parties to determine the 

appropriate corrective action to be implemented. 

Annualized cost estimates for PWSs to perform corrective actions are estimated by 

multiplying the number of Level 1 and Level 2 corrective actions estimated by the predictive 

model, (i.e., 10 percent of Level 1 and Level 2 assessments) by the percentages in the 

compliance forecast and unit costs of corrective actions and associated reporting and 

recordkeeping. Exhibit 7.13 of the RTCR EA presents the estimated totals of non-acute and

acute MCL violations (1989 TCR) and Level 1 and Level 2 assessments (RTCR and Alternative 

options). The model predicts a total of approximately 109,000 single non-acute MCL violations, 

58,000 cases of a second non-acute MCL violation, and 16,000 acute MCL violations for the 

1989 TCR, under which some PWSs currently engage in assessment activity which may or may 

not meet the RTCR criteria (see section 7.4.5 of the RTCR EA for details). For the RTCR 

option, the model predicts approximately 104,000 Level 1 assessments and 52,000 Level 2 

assessments. For the Alternative option, the model predicts approximately 115,000120,000

Level 1 assessments and 78,00081,000 Level 2 assessments. EPA estimated a net increase in 

national annualized cost estimates incurred by PWSs for conducting corrective actions of 

$12.44M (three percent discount rate) and $11.6110.63 M (seven percent discount rate) under the 

RTCR and a net increase of $13.5013.79M (three percent discount rate) and $11.8712.09M 

Comment [EPA171]: Corrected 

11/15/12

Comment [EPA172]: Corrected 

11/15/12
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

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(seven percent discount rate) under the Alternative option. The annualized net present value 

total and net change cost estimates for PWSs to perform corrective actions under the 1989 TCR, 

RTCR, and Alternative options are presented in Exhibit VI-16 of this preamble.

The differences in the net change in corrective action costs between the RTCR and 

Alternative option are a function of the different number of assessments estimated to be 

performed in the predictive model.

g. Public notification. Estimates of PWS unit costs for PN are derived by multiplying PWS 

labor rates from section 7.2.1 of the RTCR EA and burden hour estimates derived from the Draft 

Information Collection Request for the Public Water System Supervision Program (USEPA 

2008b). PWS PN unit cost estimates are presented in Exhibit 7.19 of the RTCR EA.

Total and net change in annualized net present value costs for PN under the RTCR and 

Alternative options are estimated by multiplying the model estimates of PWSs with acute (Tier 1 

public notification) and non-acute (Tier 2 public notification) violations by the PWS unit costs 

for performing PN activities. The RTCR cost model assumed that all violations are addressed 

following initial PN, and no burden is incurred by PWSs for repeat notification. EPA estimated 

a net decrease in national annualized cost estimates incurred by PWSs for public notification of 

$3.49M (three percent discount rate) and $3.35M (seven percent discount rate) under the RTCR 

and a net decrease of $3.413.40M (three percent discount rate) and $3.263.25M (seven percent 

discount rate) under the Alternative option. The annualized net present value total and net cost 

estimates for PWSs to perform public notification under the 1989 TCR, RTCR, and Alternative 

options are presented in Exhibit VI-16 of this preamble. 

Comment [EPA173]: Corrected 

11/15/12
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A significant reduction in costs is estimated due to the elimination of Tier 2 public 

notification for non-acute/monthly MCL violations under both the RTCR and Alternative 

options.

3. State costs

EPA estimated that States as a group incur a net increase in national annualized present value 

costs under the RTCR option of $0.2M (at three percent discount rate) and $0.4M (at seven 

percent discount rate) and under the Alternative option of $0.3M (at three percent discount rate) 

and $0.6M (at seven percent discount rate). State costs include implementing and administering 

the rule, revising sample siting plans, reviewing sampling results, conducting annual site visits, 

reviewing completed assessment forms, tracking corrective actions, and tracking public 

notifications. The costs presented in the RTCR EA are summary costs; costs to individual states 

vary based on state programs and the number and types of systems in the state. The following 

sections summarize the key assumptions that EPA made to estimate the costs of the RTCR and 

Alternative options to States. Chapter 7 of the RTCR EA provides a description of the analysis.

a. Rule implementation and annual administration. States incur administrative costs to 

implement the RTCR. These implementation costs are not directly required by specific 

provisions of the RTCR alternatives, but are necessary for States to ensure the provisions of the 

RTCR are properly carried out. States need to allocate time for their staff to establish and 

maintain the programs necessary to comply with the RTCR, including developing and adopting 

State regulations and modifying data management systems to track new required PWS reports to 

the States. Time requirements for a variety of State agency activities and responses are estimated 

in this EA. Exhibit 7.4 of the RTCR EA lists the activities required to revise the program 

following promulgation of the RTCR along with their respective costs and burden including, for 
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Page 183 of 325

example, the net change in State burden associated with tracking the monitoring frequencies of 

PWSs (captured under “modify data management systems”). EPA estimated a net increase in 

national annualized cost estimates incurred by States for rule implementation of $0.18M (three 

percent discount rate) and $0.26M (seven percent discount rate) under either the RTCR or the 

Alternative option. Because time requirements for implementation and annual administration 

activities vary among State agencies, EPA recognizes that the unit costs used to develop national 

estimates may be an over- or under-estimate for some States. The annualized net present value

total and net change cost estimates for States to implement and administer the rule under the 

1989 TCR, RTCR, and Alternative options are presented in Exhibit VI-16 of this preamble.

b. Sample siting plan revision. Under the RTCR and Alternative options, States are 

expected to incur one-time costs to review sample siting plans and recommend any revisions to 

PWSs. Under the 1989 TCR option, no additional burden or costs are incurred by States to 

review sample siting plans, as these PWSs’ sample siting plans have already been reviewed and 

approved. State costs are based on the number of PWSs developing revised sample siting plans 

each year. Based on previous experience, EPA estimated that States require one to four hours to 

review revised sample siting plans and provide any necessary revisions to PWSs, depending on 

PWS size. EPA estimated a net increase in national annualized cost estimates incurred by States 

for reviewing sample siting plans of $0.42M (three percent discount rate) and $0.59M (seven 

percent discount rate) under either the RTCR or the Alternative option. The annualized net 

present value total and net change cost estimates for States to review and revise sample siting 

plan under the 1989 TCR, RTCR, and Alternative options are presented in Exhibit VI-16 of this 

preamble.
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c. Monitoring. EPA assumed that States incur a monthly 15-minute burden to review each 

PWS’s sample results under the 1989 TCR. This estimate reflects the method used to calculate 

reporting and recordkeeping burden under the 1989 TCR in the Draft Information Collection 

Request for the Microbial Rules (USEPA 2008a). Because the existing method calculates cost 

on a per PWS basis and the total number of PWSs is the same for cost modeling under the 1989 

TCR and the RTCR and Alternative options, the net change in costs for reviewing monitoring 

results is assumed to be zero for the RTCR and Alternative options (as shown in Exhibit VI-16 

of this preamble). Specific actions by States related to positive samples are accounted for under 

the actions required in response to those samples.

d. Annual site visits. Under the RTCR option, any PWS on an annual monitoring schedule 

is required to also have an annual site visit conducted by the State or State-designated third party. 

A voluntary Level 2 site assessment can also satisfy the annual site visit requirement. In many 

cases a sanitary survey performed during the same year can also be used to satisfy this 

requirement. Although similar site visits are not currently required under the 1989 TCR, 

discussions with States during the TCRDSAC proceedings revealed that some do, in fact, 

conduct such site visits for PWSs on annual monitoring schedules. Because of the high cost for 

an annual site visit by a State, for this analysis EPA assumed that no States choose to conduct 

annual site visits unless they already do so under the 1989 TCR. Therefore, for overall costing 

purposes, no net change in State or PWS costs are assumed for annual monitoring site visits 

under the RTCR option or Alternative option (as shown in Exhibit VI-16 of this preamble).

e. Assessments. States incur burden to review completed Level 1 and Level 2 assessment 

forms required to be filed by PWSs under the RTCR and Alternative options. Although specific 

forms are not required under the 1989 TCR, EPA assumes that PWSs engage in some form of 

Comment [JL174]: I assume this 

leads to a decrease in systems on 

annual monitoring, since only those 

systems with annual site visits will be 

allowed to stay on annual monitoring. 

Is this reflected in your cost analysis?

Comment [EPA175]: It is. The 

percentage of systems that initially 

have annual monitoring is reduced to 

the percentage of systems that have 

annual site visits. Those systems that 

no longer have annual monitoring are 

assumed to have baseline quarterly 

monitoring and the cost for that 

monitoring is accounted for. 
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consultation with the State when they have positive sample results and MCL violations. For 

costing purposes, EPA assumes that the level of effort required for such consultations under the 

1989 TCR is the same as that which would be required for consultations that occur when an 

assessment is conducted under the RTCR and Alternative options. State costs for the RTCR and 

Alternative options are based on the number of PWSs submitting assessment reports. EPA 

estimated that State burden to review PWS assessment forms ranges from one to eight hours 

depending on PWS size and type and the level of the assessment. This burden includes any time 

required to consult with the PWS about the assessment report. 

Although some States may choose to conduct assessments for their PWSs, EPA does not 

quantify these costs. The costs are attributed to PWSs that are responsible for insuring ensuring 

that assessments are done. 

As explained in chapter 7 of the RTCR EA, EPA assumes a certain level of assessment 

activity already occurs under the 1989 TCR based on discussions with the technical workgroup 

supporting the advisory committee. Under the RTCR option, the overall number of Level 1 and 

Level 2 assessment triggers decreases compared to the 1989 TCR as a function of reduced 

occurrence over time. This reduction in assessments under the RTCR option is estimated to 

translate directly to a small national cost savings ($0.08M at either three or seven percent 

discount rate) for sStates. The overall number of Level 1 and Level 2 assessments is higher 

under the Alternative option as a result of the initial monthly monitoring requirements for all 

PWSs. The increase in the number of assessments under the Alternative option is estimated to 

translate directly to a national cost increase ($0.030.05M at three percent discount rate and 

$0.070.08M at seven percent discount rate) for sStates. The annualized net present value total 

and net change cost estimates for States to review completed Level 1 and Level 2 assessment 

Comment [JL176]: Did states have 

any concerns with this assumption?

Comment [EPA177]: No comments 

were received on this issue.

Comment [EPA178]: Yes, we meant 

triggers

Comment [JL179]: See earlier 

comment. Do you mean triggers? 

Since assessments are not required 

under the TCR, one would expect 

them to increase even if the number of 

triggers decreases.

Comment [EPA180]: Corrected 

11/15/12
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forms under the 1989 TCR, RTCR, and Alternative options are presented in Exhibit VI-16 of this 

preamble.

f. Corrective actions. For each corrective action performed under the RTCR and 

Alternative options, States incur recordkeeping and reporting burden to review assessment forms 

and coordinate with PWSs. This includes burden incurred from any optional consultations States 

may conduct with PWSs or outside parties to determine the appropriate corrective action to be 

implemented. There are no State costs for corrective action under the 1989 TCR because 

corrective action is not required under the 1989 TCR. The number of corrective actions under 

the RTCR option is estimated to translate to a national net annualized cost increase to States of 

$0.01M at either three or seven percent discount rate. The number of corrective actions under 

the Alternative option is estimated to translate to a national net annualized cost increase to States 

of $0.02M at either three or seven percent discount rate. See Exhibit VI-16 of this preamble.

g. Public notification. Under the 1989 TCR, RTCR, and Alternative options, States incur 

recordkeeping and reporting burden to provide consultation, review the public notification 

certification, and file the report of the violation. A significant reduction in costs is estimated due 

to the elimination of Tier 2 public notification for non-acute MCL violations under the RTCR 

and Alternative options. Because State costs are calculated on a per-violation basis, State costs 

decline. Under the Alternative option, some of the decrease in cost is offset by additional Tier 1 

public notification from the increase in the number of E. coli MCL violations detected. Burden 

hour estimate for State unit PN costs are derived from the Draft Information Collection Request 

for the Public Water System Supervision Program (USEPA 2008b). EPA estimated a net 

decrease in national annualized cost estimates incurred by States for public notification of 

$0.38M (three percent discount rate) and $0.36M (seven percent discount rate) under the RTCR 
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and a net decrease of $0.36M (three percent discount rate) and $0.34M (seven percent discount 

rate) under the Alternative option. The annualized net present value total and net change cost 

estimates for States to track public notifications under the 1989 TCR, RTCR, and Alternative 

options are presented in Exhibit VI-16 of this preamble.

4. Nonquantifiable costs

EPA believes that all of the rule elements that are the major drivers of the net change in costs 

from the 1989 TCR have been quantified to the greatest degree possible. However, cost 

reductions related to fewer monitoring and reporting violations are not specifically accounted for 

in the cost analysis, and their exclusion from consideration may result in an overestimate of the 

net increase in cost between the 1989 TCR option and the RTCR option or Alternative option.

Furthermore, under the 1989 TCR, RTCR, and Alternative options, Tier 3 public notification 

for monitoring and reporting violations are assumed to be reported once per year as part of the 

Consumer Confidence Reports (CCRs). Because of the use of the CCR to communicate Tier 3 

public notification on a yearly basis, no cost differential between the current 1989 TCR and the 

RTCR and Alternative options is estimated in the cost model. However, the advisory committee 

concluded that significant reductions in monitoring and reporting violations may be realized 

through the revised regulatory framework of the RTCR, which includes new consequences for 

failing to comply with monitoring provisions such as the requirement to conduct an assessment 

or ineligibility for reduced monitoring. These possible reductions have not been quantified. 

System resources used to process monitoring violation notices for the CCR and respond to 

customer inquiries about the notices, as well as State resources to remind systems to take 

samples, may be reduced if significant reductions in monitoring and reporting violations are 

realized. Exclusion of this potential cost savings may lead to an underestimate of the PN cost 
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savings under both the RTCR and Alternative option. Such cost savings to States may be 

significant given the occurrence of monitoring and reporting violations under the 1989 TCR. 

Additionally, as an underlying assumption to the costing methodology, EPA assumed that all 

PWSs subject to the RTCR requirements are already complying with the 1989 TCR. There may 

be some PWSs that are not in full compliance with the 1989 TCR, and if so, additional costs and 

benefits may be incurred. EPA does not anticipate non-compliance when performing economic 

analyses for NPDWRs, therefore those costs and benefits are not captured in this analysis.

G. Potential Impact of the RTCR on Households 

The household cost analysis considers the potential increase in a household’s annual water 

bill if a CWS passed the entire cost increase resulting from the rule on to their customers. This 

analysis is a tool to gauge potential impacts and should not be construed as a precise estimate of 

potential changes to household water bills. State costs and costs to TNCWSs and NTNCWSs are 

not included in this analysis since their costs are not typically passed through directly to 

households. Exhibit VI-22 presents the mean expected increases in annual household costs for 

all CWSs, including those systems that do not have to take corrective action. Exhibit VI-22 also 

presents the same information for CWSs that must take corrective action. Household costs tend 

to decrease as system size increases, due mainly to the economies of scale for the corrective 

actions. 

The first category in Exhibit VI-22 presents net costs per household under the RTCR and 

Alternative options for all rule components spread across all CWSs. In this scenario, 

cComparison to the 1989 TCR shows a cost savings for some households. For those households 

that are expected to see a cost increase, tThe average annual water bill is expected to increase by 

six cents or less on average per year. 

Comment [EPA181]: ok

Comment [EPA182]: Revisions to 

more accurately describe what the 

table reflects. 

11/15/12
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While the average increase in annual household water bills to implement the RTCR option is 

well less than a dollar, customers served by a small CWS that have to take corrective actions as a 

result of the rule incur slightly larger increases in their water bills. The subsequent categories of 

the exhibit present net costs per household for three different subsets of CWSs: (1) CWSs that 

perform assessments but no corrective actions, (2) CWSs that perform corrective actions, and (3) 

CWSs that do not perform assessments or corrective actions. Approximately 67 percent of 

households are served by CWSs that perform assessments but do not perform corrective actions 

over the 25-year period of analysis (because no sanitary defects are found). These households 

experience a slight cost savings on an annual basis, due to a slight reduction in monitoring and 

public notification costs. The nine percent of households belonging to CWSs that perform 

corrective actions over the 25-year period of analysis experience an increase in annual net 

household costs of less than $0.70 on average for CWSs serving greater than 4,100 people to 

approximately $4.50 on average for CWSs serving 4,100 or fewer people on an annual basis. 

EPA estimated that 24 percent of households are served by CWSs that do not perform 

assessments or corrective actions over the 25-year period of analysis because they never exceed 

an assessment trigger. This group of households served by small systems (4,100 or fewer 

people) experiences a slight cost change on an annual basis, comparable to those performing 

assessments but no corrective actions. Overall, the main driver of additional household costs 

under the RTCR is corrective actions.

Exhibit VI-22 Summary of Net Annual Per-Household Costs for the RTCR (2007$)

Population Served by 

PWS

3% Discount Rate 7% Discount Rate

RTCR Option Net 

Cost per Household

Alternative Option 

Net Cost per 

Household

RTCR Option Net 

Cost per Household

Alternative Option 

Net Cost per 

Household

All Community Water Systems (CWSs)

≤4,100 0.08 0.10 0.11 0.13 

>4,100 0.05 0.05 0.05 0.05 

Total 0.06 0.06 0.05 0.05 

Comment [JL183]: Why?

Comment [EPA184]: Monitoring 

costs are lower (for systems taking 

fewer than 5 routine samples per 

month) since they have less repeat 

routine monitoring whenever they 

have one positive TC in preceding 

month. Also some lower PN costs.

JL: OK, see suggested edit.

EPA – ok with this edit.

Comment [EPA185]: These numbers 

did not change for the alternative 

option, due to rounding

11/15/12
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Community Water Systems (CWSs) performing Level 1/Level 2 Assessments (and no Corrective Actions)

≤4,100 (0.22) (0.19) (0.16) (0.13)

>4,100 (0.01) (0.01) (0.01) (0.01)

Total (0.02) (0.02) (0.01) (0.01)

Community Water Systems (CWSs) performing Corrective Actions

≤4,100 4.47 4.51 3.93 3.98 

>4,100 0.66 0.66 0.55 0.55 

Total 0.80 0.80 0.68 0.68 

Community Water Systems (CWSs) not performing Level 1/Level 2 Assessments, or Corrective Actions

≤4,100 (0.00) 0.02 0.04 0.06 

>4,100 - - - - 

Total (0.00) 0.00 0.01 0.02 

Source: RTCR EA (USEPA 2012a)

H. Incremental Costs and Benefits 

The RTCR regulatory options achieve increasing levels of benefits at increasing levels of 

costs. The regulatory options for this rule, in order of increasing costs and benefits (Option 1 

lowest, and option Option 3 highest) are as follows:

• Option 1: 1989 TCR option

• Option 2: RTCR option

• Option 3: Alternative option

Incremental costs and benefits are those that are incurred or realized to reduce potential 

illnesses and deaths from one alternative to the next more stringent alternative. Estimates of 

incremental costs and benefits are useful when considering the economic efficiency of different 

regulatory alternatives considered by EPA. One goal of an incremental analysis is to identify the 

regulatory alternatives where net social benefits are maximized. However, incremental net 

benefits analysis is not possible when benefits are discussed qualitatively and are not monetized, 

as is the case with the RTCR. 

However, incremental analysis can still provide information on relative cost-effectiveness of 

different regulatory options. For the RTCR, only costs were monetized. While benefits were not 

quantified, an indirect proxy for benefits was quantified. To compare the additional net cost 
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increases and associated incremental benefits of the RTCR and the Alternative options, benefits 

are presented in terms of corrective actions performed since performance of corrective actions is 

expected to have the impact that is most directly translatable into potential health benefits.

Exhibit VI-23 shows the incremental cost of the RTCR over the 1989 TCR and the 

Alternative option over the RTCR option for costs annualized using three percent and seven 

percent discount rates. The incremental benefits of the Alternative option in terms of 

incremental corrective actions performed (118 at three percent and 144 and seven percent 

discount rates) are fewer than for the RTCR (208 at three percent and 202 at seven percent 

discount rates), despite the increased costs. The non-monetized corrective action endpoints are 

discounted in order to make them comparable to monetized endpoints. The relationship between 

the incremental costs and benefits is examined further with respect to cost effectiveness in 

section VI.M of this preamble, Benefit Cost Determination for the RTCR.

Exhibit VI-23 Incremental Net Change in Annualized Present Value Costs ($Millions, 

2007$) and Benefits (Number of Corrective Actions)

Regulatory Option Costs ($Millions) Benefits

(L2 Corrective Actions)

3% 7% 3% 7%

1989 TCR 186.1 178.8 No change3 No change3

RTCR 200.4 193.0 208 202

Incremental RTCR1 14.3 14.2 208 202

Alternative Option 215.7 210.5 336 355

Incremental Alternative

Option2 15.3 17.5 128 153 1 Represents the incremental net change of the RTCR option over the 1989 TCR option. 2 Represents the incremental net change of the Alternative option over the RTCR option. Add incremental net 

change for Alternative option to incremental net change for RTCR option to calculate the total net change of the 

Alternative option over the 1989 TCR option.

Note: The RTCR occurrence model yields the number of corrective actions that are expected to be implemented in 

addition to (net of) those already implemented under the 1989 TCR. The model does not incorporate an estimate of 

the number of corrective actions implemented per year under the 1989 TCR and does not yield a total for the RTCR 

and Alternative option that includes the 1989 TCR corrective actions. Benefits shown include corrective actions 

based on L2 assessments. Detailed benefits and cost information is provided in Appendices A and C, respectively, 

of the RTCR EA (USEPA 2012a). 3 As explained in section VI.F.2.f of this preamble, Corrective actions, for modeling purposes, EPA estimates the 

net change only in the number of corrective actions performed under the RTCR and Alternative options compared to 

Comment [JL186]: I will not object 

to your including this table, bc of the 

incremental analysis requirements of 

SDWA. But bc of the way you are 

measuring benefits, these numbers are 

meaningless. You use a measure of 

benefits that directly corresponds to 

the main source of costs. Further, the 

“costs” of these corrective action are 

based completely on highly 

speculative assumptions. Please don’t 

discuss them as if they have any 

significance.

Comment [EPA187]: OK with 

deleting text but keeping the table in.

Comment [EPA188]: Total and 

incremental Alternative option costs 

and benefits as corrected are higher.

At a 3% discount rate, total and net 

costs increased by $1.7M, and total 

and net benefits increased by 10 

corrective actions.

11/15/12
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the 1989 TCR and thus did not quantify the (non-zero) baseline number of corrective actions performed under the 

1989 TCR.

I. Benefits from Simultaneous Reduction of Co-occurring Contaminants

As discussed in section VI.E of this preamble, Anticipated Benefits of the RTCR, the potential 

benefits from the RTCR include avoidance of a full range of health effects from the consumption 

of fecally contaminated drinking water, including the following: acute and chronic illness, 

endemic and epidemic disease, waterborne disease outbreaks, and death.

Systems may choose corrective actions that also reduce other drinking water contaminants as 

a result of the fact that the corrective action eliminates a pathway of potential contamination into 

the distribution system. For example, eliminating a cross connection reduces the potential for 

chemical contamination as well as microbial. Due to a lack of contamination co-occurrence data 

that could relate to the effect that treatment corrective action may have on contamination 

entering through distribution system pathways, EPA has not quantified such potential benefits.

J. Change in Risk from Other Contaminants

All surface water systems are already required to disinfect under the SWTR (USEPA 1989b, 

54 FR 27486, June 29, 1989) but the RTCR could impact currently undisinfected ground water 

systems. If a previously undisinfected GW ground water system chooses disinfection as a 

corrective action, the disinfectant can react with pipe scale causing increased risk from some 

contaminants that may be entrained in the pipe scales and other water quality problems. 

Examples of contaminants that could be released include lead, copper, and arsenic. Disinfection 

could also possibly lead to a temporary discoloration of the water as the scale is loosened from 

the pipe. These risks can be addressed by gradually phasing in disinfection to the system, by 
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targeted flushing of distribution system mains, and by maintaining an effective corrosion control 

program. 

Introducing a disinfectant could also result in an increased risk from disinfection byproducts 

(DBPs). Risk from DBPs has already been addressed in the Stage 1 Disinfection Byproducts 

Rule (DBPR) (USEPA 1998a) and additional consideration of DBP risk has been addressed in 

the final Stage 2 DBPR (USEPA 2006e). In general, ground water systems are less likely to 

experience high levels of DBPs than surface water systems because they have lower levels of 

naturally occurring organic materials that contribute to DBP formation. 

EPA does not expect many previously undisinfected systems to add disinfection as a result of 

either the RTCR or Alternative rule options. Ground water systems that are not currently 

disinfecting may eventually install disinfection if RTCR distribution system monitoring and 

assessments, and/or subsequent source water monitoring required under the GWR, result in the 

determination that source water treatment is required. 

K. However, these impacts were already accounted for and costed under the GWR and EPA 

does not project additional systems switching to disinfection as a result of the RTCR. See 

section 7.4.6 of the RTCR EA for a discussion on corrective action.

Effects of Fecal Contamination and/or Waterborne Pathogens on the General Population and 

Sensitive Subpopulations

It is anticipated that the requirements of the RTCR will help reduce pathways of entry for 

fecal contamination and/or waterborne pathogens into the distribution system, thereby reducing 

risk to both the general population as well as to sensitive subpopulations.

As discussed previously in this preamble, fecal contamination may contain waterborne 

pathogens including bacteria, viruses, and parasitic protozoa. Waterborne pathogens can cause a 

Comment [JL189]: I don’t see any 

basis for this conclusion. Suggest 

deleting.

Comment [EPA190]: Deleted as 

suggested
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variety of illnesses, including acute gastrointestinal illness (AGI) with diarrhea, abdominal 

discomfort, nausea, vomiting, and other symptoms. Most AGI cases are of short duration and 

result in mild illness. Other more severe illnesses caused by waterborne pathogens include 

hemolytic uremic syndrome (HUS) (kidney failure), hepatitis, and bloody diarrhea (WHO 2004). 

Chronic disease such as irritable bowel syndrome, reduced kidney function, hypertension and 

reactive arthritis can result from infection by a waterborne agent (Clark et al. 2008).

Waterborne pathogens may subsequently infect other people through a variety of other routes 

(WHO 2004). When humans are exposed to and infected by an enteric pathogen, the pathogen 

becomes capable of reproducing in the gastrointestinal tract. As a result, healthy humans shed 

pathogens in their feces for a period ranging from days to weeks. This shedding of pathogens 

often occurs in the absence of any signs of clinical illness. Regardless of whether a pathogen 

causes clinical illness in the person who sheds it in his or her feces, the pathogen being shed may 

infect other people directly by person-to-person spread, contact with contaminated surfaces, and 

other means, which are collectively referred to as secondary spread. As a result,

When sensitive subpopulations are exposed to fecal contamination and/or waterborne 

pathogens, more severe illness (and sometimes death) can occur. Examples of sensitive 

subpopulations are provided in chapter 2 of the RTCR EA. The potential health effects 

associated with sensitive population groups – children, pregnant women, the elderly, and the 

immunocompromised – are described in the following paragraphs. 

1. Risk to children, pregnant women, and the elderly

Children and the elderly are particularly vulnerable to kidney failure (hemolytic uremic 

syndrome) caused by the pathogenic bacterium E. coli O157:H7. Kidney failure in children and 

the elderly have resulted from waterborne outbreaks due to exposure to E. coli O157:H7 from 
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consuming ground water in Cabool, Missouri (Swerdlow et al. 1992); Alpine, Wyoming (Olsen 

et al. 2002); Washington County, New York (NY State DOH 2000); and Walkerton, Ontario, 

Canada (Health Canada 2000). 

The risk of acute illness and death due to viral contamination of drinking water depends on 

several factors, including the age of the exposed individual. Infants and young children have 

higher rates of infection and disease from enteroviruses than other age groups (USEPA 1999). 

Several enteroviruses that can be transmitted through water can have serious health 

consequences in children. Enteroviruses (which include poliovirus, coxsackievirus, and 

echovirus) have been implicated in cases of flaccid paralysis, myocarditis, encephalitis, 

hemorrhagic conjunctivitis, and diabetes mellitus (Dalldorf and Melnick 1965; Smith 1970; 

Berlin et al. 1993; Cherry 1995; Melnick 1996; CDC 1997; Modlin 1997). Women may be at 

increased risk from enteric viruses during pregnancy (Gerba et al. 1996). Enterovirus infections 

in pregnant women can also be transmitted to the unborn child late in pregnancy, sometimes 

resulting in severe illness in the newborn (USEPA 2000b).

Other waterborne viruses can also be particularly harmful to children. Rotavirus 

disproportionately affects children less than five years of age (Parashar et al. 1998). However, 

the pentavalent rotavirus vaccine licensed for use in the United States has been shown to be 74 

percent effective against rotavirus gastroenteritis of any severity (Dennehy 2008). For echovirus, 

children are disproportionately at risk of becoming ill once infected (Modlin 1986). According 

to CDC, echovirus is not a vaccine-preventable disease (CDC 2007). 

The elderly are particularly at risk from diarrheal diseases (Glass et al. 2000) such as those 

associated with waterborne pathogens. In the US, approximately 53 percent of diarrheal deaths 

occur among those older than 74 years of age, and 77 percent of diarrheal deaths occur among 
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those older than 64 years of age. In Cabool, Missouri (Swerdlow et al. 1992), a waterborne E. 

coli O157:H7 outbreak in a ground water system resulted in four deaths, all among the elderly. 

One death occurred from hemolytic uremic syndromeHUS (kidney failure), the others from 

gastrointestinal illness. Furthermore, hospitalizations due to diarrheal disease are higher in the 

elderly than younger adults (Glass et al. 2000). Average hospital stays for individuals older than 

74 years of age due to diarrheal illness are 7.4 days compared to 4.1 days for individuals aged 20 

to 49 (Glass et al. 2000).

It is anticipated that the requirements of the RTCR will help reduce pathways of entry for 

fecal contamination and/or waterborne pathogens into the distribution system, thereby reducing 

risk to both the general population as well as to sensitive subpopulations such as children, 

pregnant women, and the elderly.

2. Risk to immunocompromised persons

AGI symptoms may be more severe in immunocompromised persons (Frisby et al. 1997; 

Carey et al. 2004). Such persons include those with acquired immune deficiency syndrome 

(AIDS), cancer patients undergoing chemotherapy, organ transplant recipients treated with drugs 

that suppress the immune system, and patients with autoimmune disorders such as lupus. In 

AIDS patients, Cryptosporidium, a waterborne protozoa, has been found in the lungs, ear, 

stomach, bile duct, and pancreas in addition to the small intestine (Farthing 2000). 

Immunocompromised patients with severe persistent cryptosporidiosis may die (Carey et al. 

2004).

For the immunocompromised, Gerba et al. (1996) reviewed the literature and reported that 

enteric adenovirus and rotavirus are the two waterborne viruses most commonly isolated in the 

stools of AIDS patients. For patients undergoing bone-marrow transplants, several studies cited 
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by Gerba et al. (1996) reported mortality rates greater than 50 percent among patients infected 

with enteric viruses.

It is anticipated that the requirements of the RTCR will help reduce pathways of entry for 

fecal contamination and/or waterborne pathogens into the distribution system, thereby reducing 

risk to both the general population as well as to sensitive subpopulations such as the 

immunocompromised.

L. Uncertainties in the Benefit and Cost Estimates for the RTCR 

A computer simulation model was used to estimate costs and indicators of benefits of the 

RTCR. Exhibit VI-24 shows that these outputs depend on a number of key model inputs. This 

section describes analyses that were conducted to understand how uncertainties in these inputs 

contributed to uncertainty in model outputs.

Exhibit VI-24 Simulation Model, Inputs, and Outputs
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1. Inputs and their uncertainties

It is anticipated that the requirements of the RTCR will help reduce pathways of entry for 

fecal contamination and/or waterborne pathogens into the distribution system, thereby reducing 

exposure and illness from these contaminants in drinking water. These exposure and illness 

reductions could not be modeled and estimated quantitatively, due to a lack of a quantitative 

relationship between indicators and pathogens. Section VI.E.3 of this preamble, Nonquantifiable 

benefits, and chapter 6 of the RTCR EA discuss this issue qualitatively.
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Model outputs include two important indicators that are used to qualitatively describe 

benefits: E. coli occurrence in routine total coliform samples and the occurrence of Level 1 and 2 

assessments. These outputs were monitored as endpoints in the sensitivity analyses described in 

this section.

Quantified national cost estimates include costs of required monitoring, assessments, 

corrective actions, and public notifications. Total costs were monitored as end-points in the 

sensitivity analyses described in this section.

None of the inputs shown in Exhibit VI-24 is perfectly known, so each has some degree of 

uncertainty. Some of these inputs are informed directly by data, so their uncertainties are due to 

limitations of the data. For example, uncertainty about the statistical model used to characterize 

occurrence is due to the limited numbers of systems and measurements per system in the SixYear Review 2 dataset. Other inputs are informed by professional judgment, so their 

uncertainties are expressed in terms of reasonable upper and lower bounds that are, themselves, 

based on expert judgment. For example, 10 percent of assessments (representing the incremental 

increase over the 1989 TCR) are expected to result in effective corrective actions, based on 

professional judgment, with reasonable upper and lower bounds of 20 percent and 5 percent, 

respectively. 

Sensitivity analyses were conducted to assess the degree to which uncertainties about 

selected inputs contribute to uncertainty in the resulting cost estimates. The analyses focused on 

the inputs that are listed in Exhibit VI-24. Varying the assumptions about the percentages of 

corrective actions identified and the effectiveness of those actions has a less than linear effect on 

outcomes, and the RTCR option continues to be less costly than the Alternative option under all 

scenarios modeled. Exhibits 5.22a and 5.22b of the RTCR EA provide summaries of the driving 
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model parameters and indicate where in the RTCR EA the full discussion of uncertainty on each 

parameter is contained. 

Not shown in Exhibit VI-24 are some inputs that are very well known. These are inventory 

data, which include the list of all PWSs affected by the RTCR and, for each system, information 

on its source water type, disinfection practice, and population served. Although this information 

is not perfect, any uncertainty is believed to have negligible impact on model outputs. EPA did 

not conduct sensitivity analyses to evaluate the importance of these small uncertainties.

2. Sensitivity analysis

Default values of the model inputs are considered reasonable best-estimates. Model outputs 

that are obtained when the inputs are set to these default values are also considered to be 

reasonable best-estimates. EPA conducted sensitivity analyses to learn how much the outputs 

might change when individual inputs are changed from their default values. The approach taken 

was to change each input to some reasonable upper and lower bounds, based on professional 

judgment. 

Many of the uncertainties are expected to impact the model output in a similar fashion for the 

1989 TCR, RTCR, and the Alternative options. For example, an increase in a total coliform 

occurrence tends to increase the total cost and benefit estimates for all of the rule alternatives. 

Because the benefit and cost analyses focus on net changes among the 1989 TCR, RTCR, and 

Alternative options, these common sources of uncertainty may tend to cancel out in the net 

change analyses. Other uncertainties were expected to have stronger influence on net changes 

among the 1989 TCR, RTCR, and Alternative options because of their unequal influence on the 

options. For example, assumptions about the effectiveness of corrective actions influences total 

costs of the RTCR and Alternative options, but not the 1989 TCR option. 
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Results of the sensitivity analyses (reported in the RTCR EA) showed that the fundamental 

conclusions of the economic analysis do not change over a wide range of assumptions. Both the 

RTCR and Alternative options provide benefits as compared to the 1989 TCR. Varying key 

assumptions has a less than linear effect on outcomes, and the RTCR option continues to be less 

costly than the Alternative option under all scenarios modeled. See section 5.3.3.1 of the RTCR 

EA for details.

M. Benefit Cost Determination for the RTCR 

Pursuant to SDWA section 1412(b)(6)(A), EPA has determined that the benefits of the 

RTCR justify the costs. In making this determination, EPA considered quantified and 

nonquantified benefits and costs as well as the other components of the HRRCA outlined in 

section 1412(b)(3)(C) of the SDWA. 

Additionally, EPA used several other techniques to compare benefits and costs including a 

break-even analysis and a cost effectiveness analysis. EPA developed a break-even analysis to 

inform the discussion of whether the benefits justify the cost of the regulation. The break-even 

analysis (see chapter 9 of the RTCR EA) was conducted using two example pathogens 

responsible for some (unknown) proportion of waterborne illnesses in the United States: shiga 

toxin-producing E. coliC O157:H72 (STEC O157:H7) and Salmonella. In the break-even 

analysis, CDC and Economic Research Service (ERS) estimates were used for STEC O157:H7 

and Salmonella infections, respectively. Valuations of medical cases were developed using the 

ERS Foodborne Illness Calculator. Chapter 9 of the RTCR EA has a complete discussion of the 

break even analysis and how costs per case were calculated. 

 2 According to the website of the American Academy of Family Physicians

(http://www.aafp.org/afp/20000401/tips/11.html), “Shiga toxin-producing Escherichia coli is a group of bacteria 

strains capable of causing significant human disease. The pathogen is transmitted primarily by food and has become 

an important pathogen in industrialized North America. The subgroup enterohemorrhagic E. coli includes the 

relatively important serotype O157:H7, and more than 100 other non-O157 strains.”
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Based on either example pathogen considered in the breakeven analysis, a small number of 

fatal cases annually would need to be avoided, relative to the CDC’s estimate of cases caused by 

waterborne pathogens, in order to break even with rule costs. For example, under the RTCR

option, just two deaths would need to be avoided annually using a three percent discount rate 

based on consideration of the bacterial pathogen STEC O157:H7. Alternatively, approximately

3,000 or 8,000 non-fatal cases, using the enhanced or traditional benefits valuations approaches3

, 

respectively, would need to be avoided to break even with rule costs. As expected based on its 

costs, the lower cost of the RTCR option relative to the Alternative option means that fewer 

cases need to be avoided in order to break even. See Exhibit VI-25. 

As Exhibit VI-25 shows, approximately 2 deaths would need to be avoided from a 

Salmonella infection for the rule to break even. The estimated number of non-fatal Salmonella

cases that would need to be avoided to break even is approximately 10,000 or 68,000 cases under 

the enhanced and traditional benefits valuations approaches, respectively. Given the large 

number of potential waterborne pathogens shown to occur in PWSs and the relatively low net 

costs of the RTCR, EPA believes, as discussed in this section and in the RTCR EA, that the 

RTCR option is likely to at least break even. Chapter 9 of the RTCR EA has a complete 

discussion of the break-even analysis and how costs per case were calculated. 

Exhibit VI-25 Estimated Breakeven Threshold for Avoided Cases of E. coli O157:H7 and 

Salmonella

Cost of Illness (COI) 

Methodology Discount Rate RTCR Option Alternative Option

 3 Both traditional and enhanced cost of illness (COI) approaches count the value of the direct medical costs and of 

time lost that would been spent working for a wage, but differ in their assessment of the value of time lost that 

would be spent in nonmarket work (e.g., housework, yardwork, and raising children) and leisure (e.g., recreation, 

family time, and sleep). They also differ in their valuation of (other) disutility, which encompasses a range of 

factors of well- being, including both inconvenience and any pain and suffering. A complete discussion of the 

traditional and enhanced COI approaches can be found in Appendix E of the RTCR EA (USEPA 2012a).

Comment [EPA191]: The number of 

fatal and non-fatal cases required to be 

avoided under the Alternative option 

as corrected are higher.

At a 3% discount rate, these increases 

are:

E. coli O157:H7

 Traditional COI:

•1,000 non-fatal cases 

•0.2 fatal cases

 Enhanced COI:

•1,000 non-fatal cases

•0.2 fatal cases

Salmonella

Traditional COI:

•8,000 non-fatal cases 

•0.2 fatal cases

 Enhanced COI:

•1,000 non-fatal cases

•0.2 fatal cases

11/15/12
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Non-fatal cases 

only

Fatal cases 

only1

Non-fatal 

cases only

Fatal cases 

only1

E. coli O157:H7

Traditional COI

3% 8,000 1.6 17,000 3.4

7% 8,000 1.6 18,000 3.6

Enhanced COI

3% 3,000 1.6 6,000 3.4

7% 3,000 1.6 6,000 3.6

Salmonella

Traditional COI

3% 68,000 1.6 141,000 3.4 

7% 68,000 1.6 151,000 3.6 

Enhanced COI

3% 10,000 1.6 21,000 3.4 

7% 10,000 1.6 23,000 3.6 1

Calculations for fatal cases include the non-fatal cost of illness (COI) component for the underlying illness prior to 

death.

Note: The number of cases needed to reach break-even threshold is calculated by dividing the net change in costs 

for the RTCR by the average estimated value of avoided cases.

E. coli O157:H7 and Salmonella are only two of multiple pathogenic endpoints that could have been used for this 

analysis. Use of additional pathogenic contaminants in addition to these single endpoints would result in lower 

threshold values.

Detail may not add due to independent rounding.

The breakeven threshold is higher using a 7% discount rate than a 3% discount rate under the Alternative option. 

This result is consistent with the costs of the Alternative option being higher using the 7% discount rate, which is 

caused by the frontloading of costs in the period of analysis, as explained further in Chapter 7 of the RTCR EA 

(USEPA 2012a).

Cost-effectiveness is another way of examining the benefits and costs of the rule. Exhibit 

VI-26 shows the cost of the rule per corrective action avoidedimplemented. The costeffectiveness analysis, as with the net benefits, is limited because EPA was able to only partially 

quantify and monetize the benefits of the RTCR. As discussed previously and demonstrated in 

the RTCR EA, the RTCR option, achieves the lowest cost per corrective action avoided among 

the options considered. The incremental cost-effectiveness analysis shows that the RTCR has a 

lower cost per corrective action than the Alternative option. 

Exhibit VI-26 Total Net Annual Cost Per Corrective Action (CA) Implemented under 

RTCR and Alternative Options, Annualized (using three percent and seven 

percent discount rates) ($Millions, $2007)

Regulatory Scenario 3% Discount Rate 7% Discount Rate

RTCR - Net Change $ 14.3 $ 14.2 

Comment [JL192]: Table says per 

CA implemented (not avoided) and 

this is your main benefit estimate up 

to this point, if I understand your 

analysis. Let’s discuss.

Comment [EPA193]: Correct, 

changed to implemented

Comment [EPA194]: As corrected, 

the total and incremental Alternative 

option costs and benefits are now 

higher. We also put all numbers in the 

same units to make this exhibit 

consistent with its presentation in the 

EA.

At this level of rounding, the cost 

effectiveness analysis numbers did not 

change. However, at a 3% discount 

rate, the Alternative option net change 

costs increased by $1.7M, and the 

incremental number of corrective 

actions increased by 25 corrective 

actions.

11/15/121
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RTCR - Incremental Number of Corrective Actions (L1 & L2) 616 594 

RTCR - Cost Effectiveness Analysis $ 0.02 $ 0.02 

Alternative Option - Net Change $ 29.6 $ 31.7 

Alternative Option - Incremental Number of Corrective Actions 

(L1 & L2) 808 819 

Alternative Option - Cost Effectiveness Analysis $ 0.04 $ 0.04 

Note: Corrective actions include those conducted as a result of either Level 1 or Level 2 assessments. Total rule 

costs are shown in Exhibit 9.14 of the RTCR EA (USEPA 2012a). Detailed benefits and cost information is 

provided in Appendices A and C, respectively, of the RTCR EA (USEPA 2012a).

EPA also considered the incremental cost-effectiveness of the RTCR option as compared to 

the Alternative option. Exhibit VI-27 shows that in incremental terms for all PWSs, the RTCR 

option has a far lower unit cost per corrective action than the Alternative option. EPA further 

considered the group of 60,200 TNCWSs serving 100 or fewer people and using GW, which are 

the largest subset of systems by size and type. This group is expected to bear the highest 

aggregate burden under the RTCR because of the number of systems in the group; however, the 

per system cost of this group is relatively low, $86 annualized at a three percent discount rate in 

2007$. The two incremental analyses (Exhibit VI-27 and Exhibit VI-28) together indicate that, 

using a three percent discount rate to compare incremental benefits and costs, the RTCR option 

is significantly more cost-effective than the Alternative option by a factor of about four for the 

most burdened subset of systems and by a factor of greater than three when considering all PWSs 

together. Additional information about this analysis and other methods used to compare benefits 

and costs can be found in chapter 9 of the RTCR EA.

Exhibit VI-27 Incremental Rule Cost Per Corrective Action (CA) Implemented 

under RTCR and Alternative Options, Annualized (using three percent and seven 

percent discount rates) ($2007)

Regulatory Scenario 3% Discount Rate 7% Discount Rate

A. RTCR Incremental Net Costs ($ millions) 1 $14.30 $14.17

B. RTCR Incremental Net Corrective Actions (L1 & L2) 1 615.82 593.71

C. RTCR Incremental Cost per CA ($) (C = A/B) $23,224 $23,870

D. Alternative Option Incremental Net Costs ($ millions) 2 $13.59 $16.08

E. Alternative Option Incremental Net Corrective Actions 

(L1 & L2) 2 166.78 203.21

Comment [JL196]: This analysis is 

not required under SDWA and is 

based on highly speculative 

assumptions. I don’t find it at all 

informative. I suggest deleting.

Comment [EPA195]: OK, deleted
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F. Alternative Option Incremental Cost per CA ($) (F = 

D/E) $81,459 $79,133

Notes: Detail may not add due to independent rounding.

Exhibit includes only the number of corrective actions predicted by the RTCR occurrence model to be implemented 

in addition to those implemented under the 1989 TCR. Includes corrective actions (CAs) in response to both Level 

1 and Level 2 assessments. Total net costs for each option and total CAs (not incremental) are shown in Exhibit 

9.15 of the RTCR EA (USEPA 2012a). Detailed benefits and cost information is provided in Appendices A and C, 

respectively, of the RTCR EA (USEPA 2012a). 1

Represents the incremental increase of the RTCR option over the 1989 TCR.

2

Represents the incremental increase of the Alternative option over RTCR option. Add incremental net values for 

Alternative option to incremental net values for RTCR option to calculate total net values of Alternative option over 

1989 TCR. 

Exhibit VI-28 Incremental Rule Cost Per Corrective Action (CA) for TNCWSs using GW 

Implemented under RTCR and Alternative Options, Annualized (using three 

percent and seven percent discount rates) ($2007)

Regulatory Scenario 3% Discount Rate 7% Discount Rate

1. RTCR Incremental Net Costs ($ millions)1 $5.3 $5.3

2. RTCR Incremental Corrective Actions (L1 & L2) (TNCWS <101 

only)1 287 275

3. RTCR Incremental Cost per CA ($) $18,496 $19,357

4. Alternative Option Incremental Net Costs ($ millions)2 $8.3 $9.8 

5. Alternative Option Incremental Corrective Actions (L1 & L2) 

(TNCWS <101 only)2 113 139

6. Alternative Option Incremental Cost per CA ($) $73,201 $70,653 1

Represents the incremental increase of the RTCR option over the 1989 TCR.

2

Represents the incremental increase of the Alternative option over RTCR option. Add incremental net values for 

Alternative option to incremental net values for RTCR option to calculate total net values of Alternative option over 

1989 TCR. 

Note: Detail may not add due to independent rounding.

Incremental Net Costs are based on TNCWSs serving <101 people. Detailed benefits and cost information is 

provided in Appendices A and C, respectively, of the RTCR EA (USEPA 2012a).

The preferred option for the final rule is the RTCR option. The analyses performed as part of 

the RTCR EA (USEPA 2012a) support the collective judgment and consensus of the advisory 

committee that the RTCR requirements provide for effective and efficient revisions to the 1989 

TCR regulatory requirements. The estimated net cost increase of the RTCR option is small 

($14M annually) as compared relative to the 1989 TCR and small compared to the net cost 

increase of the Alternative option ($28M 30M – $30M32M) as compared with relative to the 

1989 TCR. In addition, the net benefits are expected to be positive under the RTCR option and 

no backsliding in overall risk is predicted. While the number of corrective actions under the 

Comment [EPA197]: Revised

11/15/12

Comment [JL198]: You have not 

calculated any net benefits. Ok to say 

bens justify costs.
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Alternative option is greater than under the RTCR option, the achievement of these benefits is 

not as cost effective as under the RTCR option.

N. EPA's RTCR EA shows that additional monitoring is likely to lead to more corrective actions 

under the Alternative option than under either the 1989 TCR option or the RTCR option. The 

EPA Science Advisory Board (SAB) noted in its analysis of the EA (described in section VII.K 

of this preamble, Consultations with the Science Advisory Board, National Drinking Water 

Advisory Council, and the Secretary of Health and Human Services) that they are not generally 

supportive of decreased monitoring, and that overall, the Alternative option appears to address and 

protect public health sooner in time than the RTCR implementation. However, EPA concluded that 

the increased costs associated with the Alternative option are not justified by the increased 

benefits because under the RTCR option, States could conduct site visits in place of increased 

monitoring and such site visits are more protective of public health. In particular, the costeffectiveness analysis shows that the Alternative option is not as cost-effective as the RTCR 

option. 

Comments Received in Response to EPA’s Requests for Comment

In the proposal for the RTCR, EPA requested comment on the SAB’s concerns (selection of 

the RTCR option and measures for tracking long term effectiveness of RTCR), on replacement 

and maintenance costs for major distribution system appurtenances, on assumptions regarding 

State use of annual monitoring and annual site visits, and on assumptions regarding the results 

and effectiveness of Level 1 and Level 2 assessments. This section summarizes the comments 

EPA received on these issues.

1. SAB’s concerns

Most comments EPA received were in favor of the selection of the RTCR option over the 

1989 TCR and the Alternative option. Commenters thought that the additional transition costs 

Comment [EPA199]: Ok with the 

edits to this paragraph

Comment [JL200]: I note that your 

analysis projects that this will actually 

not happen.

Comment [EPA201]: We’d like to 

talk about deleting this paragraph. 

Seems like we discussed our decision 

to go with RTCR in the preceding 

paragraph and this one is not needed.

JL: I am fine with deleting this para.

EPA - Deleted
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associated with the Alternative option did not justify the relatively small increase in benefits and 

noted that over the long term the benefits for both options were extremely similar. Some 

commenters provided EPA with specific input on what kind of data to collect in order to indicate 

the long term effectiveness of the RTCR. However, most commenters instead emphasized the 

need for SDWIS to be equipped to record the data, and that necessary changes to SDWIS be 

made in time for the rule to take effect. EPA remains committed to providing the necessary 

update to SDWIS before the final rule goes into effect and will continue to work with data users 

to identify system data collection needs and measures.

2. Costs of major distribution system appurtenances

Most comments supported EPA’s decision not to include replacement or maintenance costs 

of major distribution system appurtenances under the RTCR. However, some commenters 

expressed concern that some systems, in particular small systems, do not plan for capital 

expenditures, and therefore these costs should be included. EPA continues to believe, as 

informed by the TCRDSAC deliberations, that the assessment requirement of the RTCR may 

help to identify when the useful life of an appurtenance has occurred or maintenance is required, 

but that these costs should be attributable to regular maintenance and repair, not to the RTCR. 

Therefore, EPA has not changed this assumption in the EA for the final rule.

3. Annual monitoring and annual site visits

Comments on this subject were mixed. Most commenters thought that the assumption that 

only states that currently allow annual monitoring and conduct annual site visits would continue 

to do so under the RTCRthis was a reasonable oneassumption. However, there were some 

commenters that pointed out that some States that currently do not allow annual monitoring may 

begin to allow it because of a lack of resources and because of the desire to meet only the 

Comment [JL202]: Who?

Comment [EPA203]: States. But as 

other commenters pointed out, 

including other states, this is a failure 

to conduct proper capital assessment 

and planning, and should be dealt with 

accordingly.

Comment [JL204]: Summarize again 

what your assumption was.

Comment [EPA205]: Summarized 

assumption as suggested; as edited by 

OMB.
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minimum aspects of the RTCR. Based on stakeholder input and comments received, EPA 

continues to believe that EPA’s original assumption is valid, that only States that currently allow 

annual monitoring and perform annual visits would continue to do so.

4. Effectiveness of assessments

Several commenters agreed that EPA made a reasonable assumption that 10 percent of 

assessments would lead to corrective action above what is occurring under the 1989 TCR. For 

those that did not agree the assumption was reasonable, the response was split between those that 

thought the estimate was too high, and those that thought the estimate was too low. Therefore, 

EPA has chosen to retain the estimate of 10 percent, which was originally derived with 

stakeholder input.

Several commenters supported the assumptions regarding the effectiveness of corrective 

actions. Many of these commenters stated that it would be extremely difficult to determine if 

these assumptions are accurate or not. Some commenters thought that these assumptions were 

too optimistic and that little or no benefit would be realized by the use of the assessments and 

corrective action. In the absence of strong consensus for changing these assumptions, EPA has 

elected to keep the assumptions in place.

O. Other Comments Received by EPA

In addition to comments received as a result of requests for comment, EPA also received 

comments on various technical aspects of the economic analysisEA. Those comments included 

concerns with the analysis in the following areas: EPA’s inability to quantify health benefits, 

small PWS’s possible inability to return to reduced monitoring after being triggered into monthly 

monitoring , the shift of State resources from public health related activities to tracking and 

compliance under the RTCR, and estimates about the State burden.
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1. Quantifying health benefits

Some commenters expressed concern that EPA is not quantifying benefits. Instead of 

quantifying the benefits, the RTCR EA examines the benefits in terms of trade-offs between 

compliance with the 1989 TCR and the other options considered (RTCR and Alternative 

options). As allowed under and consistent with the HRRCA requirements outlined in section 

1412 (b)(3)(C) of the SDWA, EPA used several methods to qualitatively evaluate the benefits of 

the RTCR and Alternative option. The qualitative evaluation uses both the judgment of EPA as 

informed by the TCRDSAC deliberations as well as quantitative estimates of changes in total 

coliform occurrence and counts of systems implementing corrective actions. EPA acknowledges 

that the predicted benefits of changes in total coliform occurrence and numbers of corrective 

actions implemented are a function of model assumptions, and EPA recognizes that there is some 

uncertainty with the assumptions. However, sensitivity analyses showed that the fundamental 

conclusions of the economic analysisEA do not change over a wide range of assumptions tested, 

and that the RTCR provides benefits over the 1989 TCR. 

EPA notes that the supporting analyses that formed the foundation of the RTCR EA were 

reviewed by the EPA Science Advisory Board (SAB). SAB noted in their report that “in general, 

the Committee was impressed by the work the Agency undertook. The Agency obviously did a 

great deal of work and put a significant amount of thought into making use of the limited amount 

of data.” SAB also acknowledged that “the EA represents the best possible analysis given the 

paucity of available data” (SAB 2010).

2. Return to reduced monitoring

Some commenters stated that PWSs, in particular NCWSs, will never again qualify for 

quarterly or annual monitoring under the RTCR once they are triggered into increased monthly 

Comment [JL206]: I don’t disagree 

with this general statement. However 

it would not be true for the 

incremental analyses, which is why I 

suggest you de-emphasize and/or 

eliminate them.

Comment [EPA207]: Incremental 

analyses deleted above so would like 

to keep this statement here.

Statement kept.
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monitoring. EPA disagrees with this statement. Under the RTCR, NCWSs that are triggered 

into monthly monitoring could possibly meet the criteria to once again qualify for (routine) 

quarterly or (reduced) annual monitoring in as little as one year. Some commenters stated that 

EPA has underestimated the numbers of systems that will be triggered into monthly monitoring 

based on existing noncompliance rates, with particular emphasis on systems with monitoring 

violations. 

Consistent with past EPA EA analyseis, the occurrence model and cost estimates in the EA 

do not include estimates for non-compliance with EPA regulatory requirements such as 

monitoring. In addition, EPA disagrees with many commenters’ assumptions that monitoring 

violation rates will remain the same under the RTCR. EPA believes that the rates of monitoring 

violations will decrease because of strengthened incentives for systems to monitor and the 

enhanced consequences of noncompliance. A PWS on quarterly or annual monitoring has a 

greater incentive under the RTCR to do its monitoring because if it doesn’t, it will be triggered 

into increased monitoring. The 1989 TCR did not include such a requirement. Under the RTCR, 

if a PWS does not complete its repeat samples, it will be triggered to conduct an assessment. 

With greater consequences for not completing required sampling, systems will be more likely to 

complete their monitoring. Thus, EPA believes that rates of monitoring and reporting violations 

will be lower under the RTCR than they are under the 1989 TCR. 

Many commenters had concerns with monitoring violation rates specifically for those 

systems that are on annual monitoring. EPA believes that the monitoring violation rates for these 

systems will not be as high as predicted by commenters since one of the requirements to remain 

on annual monitoring is an annual site visit by the State or a Level 2 assessment. If, at the time 

of the site visit or the Level 2 assessment, that year’s annual samples have not been taken, the 

Comment [EPA208]: EPA ok with 

this OMB addition.
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State or assessor will have the opportunity to remind the system to take the required samples, 

assist the system in taking the sample at that time, or include taking the sample as part of the site 

visit or assessment.

All triggers to increased monitoring in the RTCR are consistent with EPA’s position, as 

informed by TCRDSAC discussions, that annual monitoring is a privilege for only the most well 

run systems. Systems that are not able to meet annual monitoring requirements would not be 

considered among the most well run, and therefore would be triggered into more frequent 

monitoring. 

3. Shift of State resources

Some commenters assert that States will be overwhelmed by the burden of tracking and 

enforcement activities of RTCR because all small PWSs, especially NCWSs, will be triggered 

into monthly monitoring under the RTCR and that this will result in a significant increase in 

violations and tracking and enforcement activities. 

In order to address these concerns, EPA made a change from the proposal to this final rule by 

changing the result of a monitoring violation trigger for systems on annual monitoring. Instead 

of a monitoring violation triggering a system directly into monthly monitoring, a monitoring 

violation will now trigger the system in violation to quarterly monitoring. All other triggers (i.e., 

E. coli MCL violation, a Level 2 assessment, a coliform treatment technique violation) continue 

to move the system to monthly monitoring. This was done to address concerns that too many 

systems would end up on monthly monitoring and it would be too burdensome for both systems 

and States. This change did not affect any cost numbers in the EA since the EA does not model 

non-compliance. See sections III.C.1.b.iv, Increased monitoring, and III.C.2.b, Ground water 

NCWSs serving ≤ 1,000 people, of this preamble for a more detailed explanation of this change.

Comment [JL209]: Who? States?

Comment [EPA210]: Midwestern 

States. In response, we gave the states 

the flexibility to not count monitoring 

violations toward increased 

monitoring and monitoring increases 

first to quarterly, as described in the 

next paragraph. 
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EPA disagrees with any characterization of tracking and enforcement activities as unrelated 

to public health protection. Tracking and enforcement helps to ensure that systems take their 

samples, find contamination when it is present, and assess the system and make any necessary 

corrections improving public health protection. Thus, tracking and enforcement serves an 

integral role in the protection of public health that RTCR provides. 

4. State burden

a. Monitoring and Level 2 assessments. Some commenters expressed concern that States 

would ultimately bear the costs of conducting monitoring and Level 2 assessments of public 

water systemPWSs. Other commenters indicated that some States already cover the costs of 

monitoring and assessment-type activities under the 1989 TCR but would no longer be able to do 

so under the RTCR because the rule would require them to shift their resources to enforcement 

activities. EPA notes that while States do have the right to choose to cover the costs of 

conducting monitoring and assessments, the public water systemPWSs themselves are ultimately 

responsible for completing these activities. Neither the 1989 TCR nor the RTCR requires States 

to conduct monitoring for PWSs. The RTCR allows Level 2 assessments to be conducted by 

parties approved by the State, including the PWS where appropriate. EPA believes that there are 

many third parties that can reliably conduct Level 2 assessments, including certified operators, 

professional engineers, circuit riders and others. This flexibility should allow the State to assure 

thorough assessments without requiring the State to use its own resources to conduct them.

b. Underestimation. Some commenters said that EPA underestimated the cost for systems 

and States to read and understand the rule. Others assert that EPA underestimated the cost for 

annual administration. In calculating the estimates for systems and States to read and understand 

the rule, EPA looked to estimates prepared for other recent rulemakings, including the Aircraft 
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Drinking Water Rule (USEPA 2009, 74 FR 53590, October 19, 2009) and the Lead and Copper 

Rule Short-Term Revisions (USEPA 2007, 72 FR 57782, October 10, 2007). EPA then 

considered the rule requirements in comparison to the 1989 TCR, given that systems and States 

are well acquainted with the 1989 rule. The 4-hour figure is a national average, and may vary 

due to individual system complexity. EPA continues to believe that the estimated number of 

hours to read and understand the RTCR is logical.

VII. Statutory and Executive Order Review

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 

13563:Improving Regulation and Regulatory Review

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is a significant 

regulatory action. Accordingly, EPA submitted this action to the Office of Management and 

Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 

2011) and any changes made in response to OMB recommendations have been documented in 

the docket for this action. 

EPA estimates that the RTCR will have an overall annual impact on public water 

systemPWSs of $14 M and that the impact on small entities (PWSs serving 10,000 people or 

fewer) will be $10.0M - $10.3M annualized at three and seven percent discount rates, 

respectively. These impacts are described in sections VI, Economic Analysis (Health Risk 

Reduction and Cost Analysis), and VII.C, Regulatory Flexibility Act (RFA), of this preamble, 

respectively, and in the analysis that EPA prepared of the potential costs and benefits of this 

action, contained in the RTCR EA. 

B. Paperwork Reduction Act

Comment [JL211]: I don’t have an 

ICR for this. What is the status?

Comment [EPA212]: Will submit 

later, as is our practice, with the 

statement that the requirements are 

subject to OMB approval.
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The information collection requirements in this rule have beenwill be submitted for approval 

to the Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 

3501 et seq. The information collection requirements are not enforceable until OMB approves 

them. 

The information collected as a result of this rule will allow States/primacy agencies and EPA 

to determine appropriate requirements for specific systems and evaluate compliance with the 

proposed RTCR. Burden is defined at 5 CFR 1320.3(b) and means the total time, effort, and 

financial resources required to generate, maintain, retain, disclose, or provide information to or 

for a Federal agency. The burden for this final rule includes the time needed to conduct the 

following State and public water system (PWS) activities:

State activities:

• Read and understand the rule;

• Mobilize (including primacy application), plan, and implement;

• Train PWS and consultant staff;

• Track compliance;

• Analyze and review PWS data;

• Review sample siting plans and recommend any revisions to PWSs;

• Make determinations concerning PWS monitoring requirements; 

• Respond to PWSs that have positive samples;

• Recordkeeping;

• Review completed assessment forms and consult with the PWS about the assessment report;

• Review and coordinate with PWSs to determine optimal corrective actions to be 

implemented; and 
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• Provide consultation, review public notificationPN certifications, and file reports of 

violations.

PWS activities:

• Read and understand the rule;

• Planning and mobilization activities;

• Revise existing sample siting plans to identify sampling locations and collection schedules 

that are representative of water throughout the distribution system;

• Conduct routine, additional routine, and repeat monitoring, and report the results as required; 

• Complete a Level 1 assessment if the PWS experiences a Level 1 trigger, and submit a 

timetable form to the State to identify sanitary defects detected, corrective actions completed, 

and a timetable for any corrective actions not already completed; 

• Complete a Level 2 assessment if the PWS experiences a Level 2 trigger, and submit a form

to the State to identify sanitary defects detected, corrective actions completed , and a 

timetable for any corrective actions not already completed; 

• Correct sanitary defects found through the performance of Level 1 or Level 2 assessments

and report on completion of corrective actions as required; 

• Develop and distribute Tier 1 public notices when E. coli MCL violations occur;

• Develop and distribute Tier 2 public notices when the PWSs fail to take corrective action; 

and

• Develop and distribute Tier 3 public notices when the PWSs fail to comply with the 

monitoring requirements or with mandatory reporting of required information within the 

specified timeframe.

Comment [JL213]: This makes it 

look like submission requirements are 

different for the two levels of 

assessment. Is this true? Clarify.

Comment [EPA214]: Edited text to 

match rule language, which reads the 

same for both assessment levels. 

However, assessment forms submitted 

will likely be different. Example 

forms developed by the technical 

work group and attached to the AIP 

were different (2 page Level 1 form 

vs. 6 page Level 2 form) and will form 

the basis of guidance. States will 

determine own practices and forms. 

Best to keep these as separate items 

here as they will likely be different 

forms in practice.

Comment [EPA215]: EPA ok with 

this OMB addition.
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For the first three years after publication of the RTCR in the Federal RegisterFR, the major 

information requirements apply to 154,894 respondents. The total incremental burden associated 

with the change in moving from the information requirements of the 1989 TCR to those in the 

RTCR over the three years covered by the ICR is 2,518,878 578 hours, for an average of 839,526 

hours per year. The total incremental cost over the three-year clearance period is $71.3

millionM, for an average of $23.8 millionM per year (simple average over three years). (Note 

that this is higher than the annualized costs for the RTCR because in the EA, the up-front costs 

that occur in the first three years, as well as future costs, are annualized over a 25-year time 

horizon.) The average burden per response (i.e., the amount of time needed for each activity that 

requires a collection of information) is 5.4 hours; the average cost per response is $153. The 

collection requirements are mandatory under SDWA section 1445(a)(1). Detail on the 

calculation of the RTCR’s information collection burden and costs can be found in the 

Information Collection RequestICR for the Revised Total Coliform Rule (USEPA 2012c) and 

chapter 8 of the EA (USEPA 2012a). A summary of the burdens and costs of the collection is 

presented in Exhibit VII-1. 

Exhibit VII-1 Average Annual Net Change Burden and Costs for the RTCR ICR

Respondent 

Type

Annual 

Burden 

Hours

Cost Annual 

Responses Annual 

Labor Cost

Annual 

Operation & 

Maintenance 

(O&M) Cost

Annual 

Capital 

Cost

Total 

Annual 

Cost

PWSs 747,848 $20,171,639 $- $- $20,171,639 103,225

States and 

Territories 91,678 $3,595,421 $- $- $3,595,421 51,669

Total 839,526 $23,767,060 $- $- $23,767,060 154,894

Notes: Detail may not add exactly to total due to independent rounding.

“Annual Burden Hours” reflects an annual average for all system sizes over the 3-year ICR period.

Source: Information Collection RequestICR for the Revised Total Coliform Rule (USEPA 2012c)
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An agency may not conduct or sponsor, and a person is not required to respond to, a 

collection of information unless it displays a currently valid OMB control number. The OMB 

control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. When this ICR is 

approved by OMB, the Agency will publish a technical amendment to 40 CFR part 9 in the 

Federal RegisterFR to display the OMB control number for the approved information collection 

requirements contained in this final rule. 

C. Regulatory Flexibility Act (RFA)

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory 

flexibility analysis of any rule subject to notice and comment rulemaking requirements under the 

Administrative Procedure Act or any other statute unless the agency certifies that the rule will 

not have a significant economic impact on a substantial number of small entities. Small entities 

include small businesses, small organizations, and small governmental jurisdictions.

The RFA provides default definitions for each type of small entity. Small entities are defined 

as: (1) a small business as defined by the Small Business Administration’s (SBA) regulations at 

13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, 

town, school district or special district with a population of less than 50,000; and (3) a small 

organization that is any "not-for-profit enterprise which is independently owned and operated 

and is not dominant in its field." However, the RFA also authorizes an agency to use alternative 

definitions for each category of small entity, “which are appropriate to the activities of the 

agency” after proposing the alternative definition(s) in the Federal RegisterFR and taking 

comment. 5 USC 601(3) - (5). In addition, to establish an alternative small business definition, 

agencies must consult with SBA’s Chief Counsel for Advocacy. 
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For purposes of assessing the impacts of the RTCR on small entities, EPA considered small 

entities to be PWSs serving 10,000 or fewer people. This is the cut-off level specified by 

Congress in the 1996 Amendments to the Safe Drinking Water ActSDWA for small system 

flexibility provisions. As required by the RFA, EPA proposed using this alternative definition in 

the Federal RegisterFR (63 FR 7620, February 13, 1998), requested public comment, consulted 

with the SBA, and finalized the alternative definition in the Agency’s Consumer Confidence 

ReportCCRs regulation (63 FR 44524, August 19, 1998). As stated in that Final Rule, the 

alternative definition would be applied for all future drinking water regulations.

After considering the economic impacts of the RTCR on small entities, I certify that this 

action will not have a significant economic impact on a substantial number of small entities. The 

small entities directly regulated by this rule are small PWSs serving 10,000 or fewer people. 

These include small CWSs, NTNCWSs, and TNCWSs, entities such as municipal water systems 

(publicly and privately owned), and privately-owned PWSs and for-profit businesses where 

provision of water may be ancillary, such as mobile home parks, day care centers, churches, 

schools and homeowner associations. We have determined that only 61 of 150,672 small 

systems (0.04%) will experience an impact of more than 1% of revenues, and that none of the 

small systems will experience an impact of 3% or greater of revenue. This information is 

described further in chapter 8 of the RTCR EA.

Although this final rule will not have a significant economic impact on a substantial number 

of small entities, EPA nonetheless has tried to reduce the impact of this rule on small PWSs. 

Provisions in the RTCR that result in reduced costs for many small entities include:

• Reduced routine monitoring for qualifying PWSs serving 1,000 or fewer people.

• Reduced number of repeat samples required for systems serving 1,000 or fewer people. 

Comment [JL216]: Is this for 

everyone or just for small systems? 

Clarify.

Comment [EPA217]: Edited to 

clarify, as requested.
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• Reduced additional routine monitoring for PWSs serving 4,100 or fewer people.

• Reduced public notificationPN requirements for all systems, including small systems.

 EPA also conducted outreach to small entities and convened a Small Business Advocacy 

Review Panel to obtain advice and recommendations of representatives of the small entities that 

potentially would be subject to this rule's requirements. For a description of the Small Business 

Advocacy Review Panel and stakeholder recommendations, please see section VII.C of the 

preamble to the proposed RTCR, Regulatory Flexibility Act (RFA). 

D. Unfunded Mandates Reform Act (UMRA)

This rule does not contain a Federal mandate under the provisions of Title II of the Unfunded 

Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538 that may result in expenditures to 

State, local, and Tribal governments, in the aggregate, or to the private sector, of $100 millionM

or more in any one year. Expenditures associated with compliance, defined as the incremental 

costs beyond the 1989 TCR, will not surpass $100 millionM in the aggregate in any year. Thus, 

this rule is not subject to the requirements of sections 202 and 205 of UMRA.

The RTCR is also not subject to the requirements of section 203 of UMRA because it 

contains no regulatory requirements that might significantly or uniquely affect small 

governments. Costs to small entities are generally not significant, as described previously in 

section VII.C of this preamble, Regulatory Flexibility Act (RFA), and are detailed in the RTCR 

EA. The regulatory requirements of the final RTCR are not unique to small governments, as 

they apply to all PWSs regardless of size.

E. Executive Order 13132: Federalism

This action does not have Federalism implications. It will not have substantial direct effects 

on the States, on the relationship between the national government and the States, or on the 
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distribution of power and responsibilities among the various levels of government as specified in 

Executive Order 13132. The net change in cost for State, local, and Tribal governments in the 

aggregate is estimated to be approximately $0.10.2M and $0.4M at three percent and seven 

percent discount rates, respectively. Thus, Executive Order 13132 does not apply to this final 

rule. 

Although section 6 of Executive Order 13132 does not apply to the RTCR, EPA conducted a 

Federalism Consultation, consistent with Executive Order 13132, in July 2008. The consultation 

included a stakeholder meeting where EPA requested comments on the impacts of the potential 

revisions to the 1989 TCR with respect to State, county and local governments. EPA did not 

receive any comments in response to this consultation. In addition, the advisory committee 

included representatives of State, local and Tribal governments, and through this process EPA 

consulted with State, local, and Tribal government representatives to ensure that their views were 

considered when the AIP recommendations for the proposed RTCR were developed. EPA also 

included representatives from four states on its workgroup for developing the proposed RTCR.

In the spirit of Executive Order 13132 and consistent with EPA policy to promote 

communications between EPA and State and local governments, EPA specifically solicited 

comment on the proposed action from State and local officials. Some States were concerned 

with the burden of implementing the rule, especially those States that have a high proportion of 

non-community water systemNCWSs. Under this rule, expenditures for assessments and 

corrective actions and increased monitoring are targeted to the fraction of PWSs that are most 

vulnerable to pathways for contamination of the distribution system, thereby minimizing the 

burden for the majority of PWSs and for States implementing the rule. As described in sections 

III.E.2, Assessment, and III.C.1.b.iv, Increased monitoring, of this preamble, EPA is also 

Comment [MN218]: Sean, looks like 

this number was not properly written. 

It has been corrected to be consistent 

with the EA. Note that this number 

did not change based on the latest 

model re-run.
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providing flexibility on how the PWSs and States conduct and track assessments, and by 

changing the consequence for systems on annual monitoring that have RTCR monitoring 

violations (i.e., increase to quarterly monitoring instead of monthly monitoring). EPA also has 

plans to update SDWIS to maximize its efficiency in support of rule implementation. These 

actions should address many of the State concerns about burden.

F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments

This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 

67249, November 9, 2000). EPA consulted with Tribes throughout the development of the 

RTCR (as described in this section) and no issues that were particular to Tribal entities were 

identified.

Although Executive Order 13175 does not apply to this action, EPA consulted with Tribal 

officials in developing this action. EPA consulted with Tribal governments through the EPA 

American Indian Environmental Office; included a representative of the Native American Water 

Association on the advisory committee who helped develop and signed the AIP on

recommendations on the proposed rule; and addressed Tribal concerns throughout the regulatory 

development process, as appropriate. The consultation included participation in three Tribal 

conference calls (EPA regional Tribal call (February 2008), National Indian Workgroup call 

(March 2008), and National Tribal Water Conference (March 2008)). EPA requested comments 

on the 1989 TCR, requested suggestions for 1989 TCR revisions (March 2008), and presented 

possible revisions to the 1989 TCR to the National Tribal Council (April 2008). In addition, the 

advisory committee included a representative from the Native American Water Association who 

represented Tribal entities, and through this process EPA ensured that Tribal views were 

considered when the AIP recommendations for the proposed RTCR were developed. None of 
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these consultations identified issues that were particular to Tribal entities. EPA also specifically 

solicited additional comment on the proposed rule from Tribal officials, and no additional issues 

were identified. As a result of the Tribal consultations and other Tribal outreach, EPA has 

determined that the RTCR is not anticipated to have a negative impact on Tribal systems. Thus, 

Executive Order 13175 does not apply to this action.

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

Risks

The RTCR is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it 

is not economically significant as defined in Executive Order 12866, and because the Agency 

does not believe the environmental health or safety risks addressed by this action present a 

disproportionate risk to children. This action’s health and risk assessments regarding children 

are contained in section VI.K.1 of this preamble, Risk to children, pregnant women, and the 

elderly, and in the RTCR EA. EPA expects that the RTCR would provide additional protection 

to both children and adults who consume drinking water supplied from PWSs. EPA also 

believes the benefits of this rule, including reduced health risk, accrue more to children because 

young children are more susceptible than adults to some waterborne illnesses. For example, the 

risk of mortality resulting from diarrhea is often greatest in the very young and elderly (Rose 

1997; Gerba et al. 1996), and viral and bacterial illnesses often disproportionately affect 

children. Any overall benefits of the rule would reduce this mortality risk for children.

H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or 

Use

This rule is not a “significant energy action” as defined in Executive Order 13211 (66 FR 

28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, 
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distribution, or use of energy. Additionally, none of the requirements of this rule involve the 

installation of treatment or other components that use a measurable amount of energy.

I. National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), 

Public Law No. 104-113, 12(d) (15 U.S.C. 272 note), directs EPA to use voluntary consensus 

standards in its regulatory activities unless to do so would be inconsistent with applicable law or 

otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials 

specifications, test methods, sampling procedures, and business practices) that are developed or 

adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, 

through OMB, explanations when EPA decides not to use available and applicable voluntary 

consensus standards.

This rule involves technical voluntary consensus standards. As in the 1989 TCR, under the 

provisions of the RTCR water systems are required to use several analytical methods to monitor 

for total coliforms and/or E. coli as they are described in Standard Methods for the Examination 

of Water and Wastewater, 20th and 21st editions (Clesceri et al. 1998; Eaton et al. 2005). 

Methods included in Standard Methods are voluntary consensus standards. The 1989 TCR and 

RTCR include the same 11 methods that can be used to test for total coliforms. Four of the 11 

are voluntary consensus methods described in Standard Methods. 

J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority 

Populations and Low-Income Populations

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy 

on environmental justice. Its main provision directs federal agencies, to the greatest extent 

practicable and permitted by law, to make environmental justice part of their mission. Agencies 
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must do this by identifying and addressing, as appropriate, any disproportionately high and 

adverse human health or environmental effects of their programs, policies, and activities on 

minority populations and low-income populations in the United StatesUS.

EPA has determined that this action will not have disproportionately high and adverse human 

health or environmental effects on minority or low-income populations because it increases the 

level of environmental protection for all affected populations without having any 

disproportionately high and adverse human health or environmental effects on any population, 

including any minority or low-income population. The RTCR applies uniformly to all PWSs and 

consequently provides health protection equally to all income and minority groups served by 

PWSs. The RTCR and other drinking water regulations are expected to have a positive effect on 

human health regardless of the social or economic status of a specific population. To the extent 

that contaminants in drinking water might be disproportionately high among minority or lowincome populations (which is unknown), the RTCR contributes toward removing those 

differences by assuring that all public water systems meet drinking water standards and take 

appropriate corrective action whenever appropriate. Thus, the RTCR meets the intent of the 

Federal policy requiring incorporation of environmental justice into Federal agency missions.

K. Consultations with the Science Advisory Board, National Drinking Water Advisory Council, 

and the Secretary of Health and Human Services

In accordance with section 1412(d) and (e) of the SDWA, EPA consulted with the Science 

Advisory Board (SAB), the National Drinking Water Advisory Council (NDWAC), and the 

Secretary of the US Department of Health and Human Services on the RTCR.

EPA met with the Drinking Water Committee (DWC) of the SAB to discuss the proposed 

RTCR on May 20, 2009 (teleconference) and June 9 and 10, 2009 (Washington, DC). The SAB 
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Drinking Water Committee (DWC) review focused on (1) the data sources used to estimate 

baseline total coliform and E. coli occurrence, public water system profile, and sensitive 

subpopulations in the United StatesUS; (2) the occurrence analysis used to inform the benefits 

analysis; (3) the qualitative analysis used to assess the reduction in risk due to implementation of 

the rule requirements; and (4) analysis of the engineering costs and costs to States resulting from 

implementation of the revisions. 

Overall, the SAB DWC supported EPA’s analysis. SAB members commended EPA for 

making use of the best available data to assess the impacts of the proposed rule. The SAB DWC 

supported the decision by EPA not to quantify public health benefits, acknowledging that EPA 

had insufficient data to do so. However, they noted in their analysis of the EA that they are not 

generally supportive of decreased monitoring, and that overall, the Alternative option appears to 

address and protect public health sooner in time than the AIP proposed implementation. The SAB 

DWC recommended that EPA clarify rationales for assumptions; expand explanations of 

sensitivity analyses that were included; provide further justification in those areas in which 

sensitivity analyses were not conducted; and collect data after promulgation of the rule to allow 

EPA to better understand the public health impacts of the RTCR. 

In response to the SAB DWC recommendations, EPA conducted sensitivity analyses to 

explore a wider range of assumptions regarding the percentage of assessments leading to 

corrective actions and to demonstrate that using an annual average for occurrence provided 

results comparable to varying the occurrence based on the season. EPA also added an exhibit in 

the EA that summarizes all significant model parameters and assumptions, their influence on 

variability and uncertainty, and their most likely effect on benefits or costs. The added exhibits 

and expanded and clarified text can be found in the RTCR EA. A copy of the SAB report (SAB 

2010) is available in the docket for this rule.
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EPA consulted with NDWAC on May 28, 2009, in Seattle, Washington, to discuss the 

proposed RTCR. NDWAC members expressed concern that a rule based on the AIP sounds 

complicated and recommended that EPA provide the utilities and States with tools to help them 

understand the revised rule provisions and to assist with providing public education. In response 

to NDWAC’s concern, EPA requested comment on whether the proposed RTCR would result in 

requirements that would be easier to implement compared to the 1989 TCR.

EPA heard from commenters that the RTCR will be difficult to implement in States that 

have a lot of small NCWSs, especially the reduced and increased monitoring provisions. To 

address this concern, EPA provided flexibility to States to help them implement, and to PWSs to 

help them comply, with the monitoring provisions of the RTCR. States are given the flexibility 

to not count monitoring violations towards eligibility for a TNCWS to remain on quarterly 

monitoring or to return to quarterly monitoring as long as the system collects the make-up 

sample by the end of the next monitoring period. EPA also changed the consequence of having 

one RTCR monitoring violation for systems on annual monitoring. Instead of having to go to 

monthly monitoring, the system now moves to quarterly monitoring. See section III.C.2.b of this 

preamble, Ground water NCWSs serving ≤ 1,000 people, for more details.

NDWAC members also suggested that EPA request comment on the costs and benefits of 

reduced monitoring. Specifically, NDWAC expressed concern that a reduction in the number of 

certain samples taken (such as the reduction in the number of repeat and additional routine 

samples for some small systems) could lessen the opportunity for systems to identify violations. 

Thus, EPA requested comment on the cost and benefit of reduced monitoring.

EPA received comment that expressed concern that a reduction in the number of additional 

routine samples reduces the likelihood of detecting both total coliforms and E. coli. EPA and the 
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advisory committee recognized that a reduction in the number of samples taken could also mean 

a reduction in the number of positive samples found. However, EPA and the advisory committee 

concluded that the new assessment and corrective action provisions of the RTCR lead to a rule 

that is more protective of public health and to improvement in water quality despite the 

reductions in the number of samples taken. See section III.C.2.b of this preamble, Ground water 

NCWSs serving ≤ 1,000 people, for more details 

A few NDWAC members stated that they would like to provide EPA with additional advice 

on public notificationPN. To follow up on this request, EPA met with several NDWAC 

members on July 1, 2009, to review and discuss the 1989 TCR public notificationPN

requirements, the advisory committee's recommendations on revisions to the public 

notificationPN requirements, and to obtain feedback from NDWAC members. EPA considered 

the recommendations from NDWAC in developing the public notificationPN requirements and 

requested comment on these issues in the preamble to the proposed RTCR.

EPA consulted with NDWAC again on July 21, 2011, to discuss the draft final rule and 

comments received on the proposed RTCR, specifically regarding those areas where NDWAC 

made recommendations in the March and July 2009 consultations. The NDWAC members 

recommended that in finalizing the RTCR, EPA follow the recommendations of the TCRDSAC.

EPA completed its consultations with the US Department of Health and Human Services on 

October 5, 2009, and August 8, 2011, as required by SDWA section 1412(d). EPA provided an 

informational briefing to the Center for Food Safety office of the Food and Drug Administration 

and representatives from the Office of the Assistant Secretary for Health and the Assistant 

Secretary for Planning and Evaluation at the Department of Health and Human Services. No 

substantive comments were received as a result of the briefing and consultation.
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L. Considerations of Impacts on Sensitive Subpopulations as Required by Section 

1412(b)(3)(C)(i)(V) of the 1996 Amendments of the Safe Drinking Water Act (SDWA)

As required by Section 1412(b)(3)(C)(i)(V) of the SDWA, EPA sought public comment 

regarding the effects of contamination associated with the proposed RTCR on the general 

population and sensitive subpopulations. Sensitive subpopulations include “infants, children, 

pregnant women, the elderly, individuals with a history of serious illness, or other 

subpopulations that are identified as likely to be at greater risk of adverse health effects due to 

exposure to contaminants in drinking water than the general population” (SDWA section

1412(b)(3)(C)(i)(V), 42 U.S.C 300g-1(b)(3)(C)(i)(V)).

Pregnant and lactating women may be at an increased risk from pathogens as well as act as a 

source of infection for newborns. Infection during pregnancy may also result in the transmission 

of infection from the mother to the child in utero, during birth, or shortly thereafter. Since very 

young children do not have fully developed immune systems, they are at increased risk and are 

particularly difficult to treat.

Infectious diseases are also a major problem for the elderly because immune function 

declines with age. As a result, outbreaks of waterborne diseases can be devastating on the 

elderly community (e.g., nursing homes) and may increase the possibility of significantly higher 

mortality rates in the elderly than in the general population.

Immunocompromised individuals are a growing proportion of the population with the 

continued increase in Human Immunodeficiency VirusHIV/AIDS, the aging population, and the 

escalation in organ and tissue transplantations. Immunocompromised individuals are more 

susceptible to severe and invasive infection. These infections are particularly difficult to treat 

and can result in a significantly higher mortality than in immunocompetent persons.
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It is anticipated that the requirements of the RTCR will help reduce pathways of entry for 

fecal contamination and/or waterborne pathogens into the distribution system, thereby reducing 

exposure and risk from these contaminants in drinking water to the entire general population. 

The RTCR seeks to provide a similar level of drinking water protection to all groups including 

sensitive subpopulations, thus meeting the intent of this Federal policy. See also section VI.K of 

this preamble, Effects of Fecal Contamination and/or Waterborne Pathogens on the General 

Population and Sensitive Subpopulations, for a more detailed discussion of this topic.

M. Effect of Compliance with the RTCR on the Technical, Financial, and Managerial Capacity 

of Public Water Systems

Section 1420(d)(3) of the SDWA, as amended, requires that, in promulgating an National 

Primary Drinking Water RegulationNPDWR, the Administrator shall include an analysis of the 

likely effect of compliance with the regulation on the technical, managerial, and financial (TMF) 

capacity of PWSs. The following analysis fulfills this statutory obligation by identifying the 

incremental impact that the RTCR will have on the TMF capacity of regulated water systems. 

Analyses presented in this document reflect only the impact of new or revised requirements, as 

established by the RTCR; the impacts of previously established requirements on system capacity 

are not considered.

EPA has defined overall water system capacity as the ability to plan for, achieve, and 

maintain compliance with applicable drinking water standards. Capacity encompasses three 

components: technical, managerial, and financial. Technical capacity is the physical and 

operational ability of a water system to meet SDWA requirements. This refers to the physical 

infrastructure of the water system, including the adequacy of source water and the adequacy of 

treatment, storage, and distribution infrastructure. It also refers to the ability of system personnel 
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to adequately operate and maintain the system and to otherwise implement requisite technical 

knowledge. Managerial capacity is the ability of a water system to conduct its affairs to achieve 

and maintain compliance with SDWA requirements. Managerial capacity refers to the system’s 

institutional and administrative capabilities. Financial capacity is a water system’s ability to 

acquire and manage sufficient financial resources to allow the system to achieve and maintain 

compliance with SDWA requirements. Technical, managerial, and financial capacity can be 

assessed through key issues and questions, including the following:

Technical Capacity

Source water 

adequacy

Does the system have a reliable source of water with adequate quantity? Is the 

source generally of good quality and adequately protected?

Infrastructure 

adequacy

Can the system provide water that meets SDWA standards? What is the 

condition of its infrastructure, including wells or source water intakes, treatment 

and storage facilities, and distribution systems? What is the infrastructure’s life 

expectancy? Does the system have a capital improvement plan?

Technical knowledge 

and implementation

Are the system’s operators certified? Do the operators have sufficient knowledge 

of applicable standards? Can the operators effectively implement this technical 

knowledge? Do the operators understand the system’s technical and operational 

characteristics? Does the system have an effective O&M program?

Managerial Capacity

Ownership 

accountability

Are the owners clearly identified? Can they be held accountable for the system?

Staffing and 

organization

Are the operators and managers clearly identified? Is the system properly 

organized and staffed? Do personnel understand the management aspects of 

regulatory requirements and system operations? Do they have adequate expertise 

to manage water system operations (i.e., to conduct implementation, monitor for 

E. coli)? Do personnel have the necessary licenses and certifications?

Effective external 

linkages

Does the system interact well with customers, regulators, and other entities? Is 

the system aware of available external resources, such as technical and financial 

assistance?

Financial Capacity

Revenue sufficiency Do revenues cover costs?

Creditworthiness Is the system financially healthy? Does it have access to capital through public 

or private sources?

Fiscal management 

and controls

Are adequate books and records maintained? Are appropriate budgeting, 

accounting, and financial planning methods used? Does the system manage its 

revenues effectively?
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EPA looked at the major requirements of the RTCR that may affect the TMF capacity of 

PWSs. These requirements include: sample siting plan revision, monitoring, assessments, 

corrective actions, and public notificationPNs. Another factor that may affect the TMF capacity 

is the need for PWS personnel to familiarize themselves with the RTCR requirements. EPA 

developed a scoring system to analyze the impact of complying with these requirements on the 

TMF capacity of PWSs. A detailed discussion of EPA’s analysis is presented in chapter 8.14 of 

the RTCR EA (USEPA 2012a). 

The RTCR will apply to all PWSs and may affect 51,972 CWSs, 18,729 NTNCWSs, and 

84,136 TNCWSs – 154,837 systems in all. While some systems may require increased TMF 

capacity to comply with the new RTCR requirements, or will need to tailor their compliance 

approaches to match their capacities, most systems will not.

Small systems will likely face only a small challenge to their technical and managerial 

capacity as a result of efforts to familiarize themselves with the monitoring requirements of the 

RTCR. Routine and repeat monitoring requirements under the RTCR are essentially the same as 

under the 1989 TCR, with more explicit criteria to qualify for reduced monitoring. Therefore, 

understanding the RTCR monitoring requirements is not expected to pose many new technical or 

managerial capacity issues for small systems. 

Small system technical and managerial capacity may be affected by the assessment 

requirements of the RTCR. Performing assessments may require the system to increase staffing 

levels in addition to providing training to ensure that system staff understand how those 

assessments are to be performed. Reporting, record-keeping, and data administration 

requirements will also affect the managerial capacity of small systems.
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Page 232 of 325

Small systems that are required to take corrective action are expected to experience the most 

significant financial challenge since some corrective actions may consist of a large, one-time 

capital expenditure to resolve the problem.

Large systems will likely not face any significant challenge to their technical and managerial 

capacity as a result of efforts to familiarize themselves with the RTCR. Most large systems are 

familiar with the 1989 TCR and there are no changes in the basic monitoring requirements for 

large systems under the RTCR. They are therefore assumed to already have the TMF capacity in 

place for the RTCR. 

Only large systems performing assessments and corrective actions would be expected to face 

a significant challenge meeting the TMF capacity requirements. However, this requirement is 

only necessary when monitoring reveals potential problems, and this is not expected to occur 

significantly in large systems above that experienced under the 1989 TCR. Many large systems 

already have the TMF capacity to conduct assessments and corrective actions if they are needed. 

These systems will be affected less significantly than smaller systems that have to implement 

corrective actions because it is recognized that they are typically already implementing similar 

assessments and corrective actions when a routine monitoring sample tests positive for fecal 

indicators under the 1989 TCR.

N. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business 

Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take 

effect, the agency promulgating the rule must submit a rule report, which includes a copy of the 

rule, to each House of the Congress and to the Comptroller General of the United StatesUS. 

EPA will submit a report containing this rule and other required information to the U.S. Senate, 
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 233 of 325

the U.S. House of Representatives, and the Comptroller General of the United StatesUS prior to 

publication of the rule in the Federal RegisterFR. A Major rule cannot take effect until 60 days 

after it is published in the Federal RegisterFR. This action is not a “major rule'' as defined by 5 

U.S.C. 804(2). This rule will be effective [INSERT DATE 60 DAYS AFTER DATE OF 

PUBLICATION IN THE FEDERAL REGISTER].
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 234 of 325

VIII. References 

American Water Works Association (AWWA). 2010. Comment submitted on the Proposed 

Revised Total Coliform Rule. www.regulations.gov. Docket ID EPA-HQ-OW-2008-0878-0199.

Bennett, J. V., S.D. Holmberg, M.F. Rogers, and S.L. Solomon. 1987. Infectious and Parasitic 

Diseases. Closing the Gap: The Burden of Unnecessary Illness. Eds. R.W. Amler & H.B Dull.

Oxford University Press, New York. 102-114.

Berlin, L.E., M.L. Rorabaugh, F. Heldrich, K. Roberts, T. Doran, and J.F. Modlin. 1993. 

Aseptic meningitis in infants < 2 years of age: diagnosis and etiology. J. Infect. Dis. 

168:888-892.

Berry, D., C. Xi, and L. Raskin. 2006. Microbial ecology of drinking water distribution systems. 

Current opinion in biotechnology 17, 297-302

Brown, M.R.W. and J. Barker. 1999. Unexplored reservoirs of pathogenic bacteria: protozoa 

and biofilms. Trends in microbiology 7:46-50.

Carey, C.M., H. Lee, and J.T. Trevors. 2004. Biology, persistence and detection of 

Cryptosporidium parvum and Cryptosporidium hominis oocyst. Wat. Res. 38: 818-862.

CDC. 1997. Paralytic Poliomyelitis United States, 1980-1994. Morbidity and Mortality Weekly 

Report Weekly. 46(04):79-83. Available online at 

http://www.cdc.gov/mmwR/preview/mmwrhtml/00045949.htm. Accessed July 2009.
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Page 235 of 325

CDC. 2007. “List of Vaccine-Preventable Diseases.” http://www.cdc.gov/vaccines//vpd-vac/vpdlist.htm. June13, 2007. Accessed July 2009.

Cherry, J.D. 1995. Enteroviruses. In: Infectious Diseases of the Fetus and Newborn Infant, 4th

ed. Remington and Klein, eds. Philadelphia, WB Saunders Company. pp. 404-446.

Clark, W. F., J.J. Mcnab, and J. M. Sontrop. 2008. The Walkerton Health Study, 2002-2008, 

Final Report Submitted to the Ontario Ministry of Health and Long-Term Care. 76 pp. (includes 

list of peer reviewed publications).

Clark, W. F., J.M. Sontrop, J.J. Macnab, M. Salvadori,, L. Moist, R. Suri, and A. X. Garg. 2010. 

Long term risk for hypertension, renal impairment, and cardiovascular disease after 

gastroenteritis from drink water contaminated with Escherichia coli O157:H7: a prospective 

cohort study. British Medical Journal 2010;341:c6020 doi:10.1136/bmj.c6020.

Clesceri, L.S., A.E. Greenberg, and A.D. Eaton, eds. 1998. Standard Methods for the 

Examination of Water and Wastewater, 20th ed. Washington, DC. American Public Health 

Association.

Cooley, M., D. Carychao, L. Crawford-Miksza, M.T. Jay, C. Myers, C. Rose, C. Keys, J. Farrar, 

and R.E. Mandrell. 2007. Incidence and tracking of Escherichia coli O157:H7 in a major produce 

production region in California. PLoS ONE. November 2007. 14;2(11):e1159. 

doi:10.1371/journal.pone.0001159.
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 236 of 325

Craun, G.F. 1996. Cases of illness required to initiate a waterborne outbreak investigation. 

Unpublished report to SAIC. September 18, 1996. 38 pp.

Craun, G.F., R.L. Calderon and T.J. Wade, 2006. Assessing waterborne risks: an introduction. 

Journal of Water and Health 4(2):3-18.

Dalldorf, G., and J.L. Melnick. 1965. Coxsackie Viruses. In: Viral and Rickettsial Infections of 

Man. 4th ed. F.L. Horsefall and L. Tamms. eds. Philadelphia, J.B. Lippincott. pp. 474-511.

Dennehy, P.H. 2008. Rotavirus vaccines: an overview. Clinical Microbiology Reviews 

21(1):198-208.

Eaton, A.D., L.S. Clesceri, E.W. Rice, and A.E. Greenberg, eds. 2005. Standard Methods for the 

Examination of Water and Wastewater, 21st ed. Washington, DC. American Public Health 

Association.

Edberg, S.C., E.W. Rice, R.J. Karlin and M. J. Allen. 2000. Escherichia coli: the best biological 

drinking water indicator for public health protection. Journal of Applied Microbiology 88:106S116S.

Farthing, M.J. 2000. Clinical Aspects of Human Cryptosporidiosis. In: Cryptosporidiosis and 

Microsporidiosis. vol. 6. 1st ed. F. Petry, ed. New York. S. Kargar. pp. 50-74.
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 237 of 325

Feng, P. 1995. Escherichia coli Serotype O157:H7: Novel Vehicles of Infection and Emergence 

of Phenotypic Variants, Emerging Infectious Diseases. 1(2):47-52.

Fricker, C., P. Warden, D. Silvaggio, E. Gleeseman, R. Tamanaha, J. Rust, B. Eldred. 2003. 

Comparison of Five Commercially Available Methods for Detection of Coliform and E. coli. 

AWWA Water Quality and Technology Conference. Philadelphia, PA. November 2003.

Frisby, H.R., D.G. Addiss, W.J. Reiser, B. Hancock, J.M. Vergeront, N.J. Hoxie, J.P. Davis. 

1997. Clinical and epidemiologic features of a massive waterborne outbreak of cryptosporidiosis 

in persons with HIV infection. J. AIDS and Hum. Retrovirology 16:367-373.

Garg, A.X., R.S. Suri, N. Barrowman, F. Rehman, D. Matsell, M. P. Rosas-Arellano, M. 

Salvadori, R. B. Haynes, W.F. Clark. 2003. Long-term Renal Prognosis of Diarrhea-Associated 

Hemolytic Uremic Syndrome, A Systematic Review, Meta-analysis, and Meta-regression. 

Journal American Medical Association. 290(10):1360-1370.

Gerba, C. P., J. B. Rose, and C. N. Haas. 1996. Sensitive Populations: who is at the greatest risk? 

Int. J. Food Micro. 30:113-123.

Glass, R.I., J. Noel, T. Ando, R. Fankhauser, G. Belliot, A. Mounts, U.D. Parashar, J.S. Bresee, 

and S.S. Monroe. 2000. The Epidemiology of Enteric Caliciviruses from Humans: A 

Reassessment Using New Diagnostics. Journal of Infectious Diseases. 181(Suppl 2):S254-61.
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 238 of 325

Gould, L.H., L. Demma, T.F. Jones, S. Hurd, D.J. Vugia, K. Smith, B. Shiferaw, S. Segler, A. 

Palmer, S. Zensky, P.M. Griffin, and the Emerging Infections Program FoodNet Working Group. 

2009. Hemolytic Uremic Syndrome and Death in Persons with Escherichia coli O157:H7 

Infection, Foodborne Diseases Active Surveillance Network Sites, 2000-2006. Clincal Infectious 

Diseases. 49:1480-1485. DOI: 10.1086/644621.

Griffin, P.M. and R.V. Tauxe, 1991. The Epidemiology of Infections Caused by Escherichia coli 

O157:H7, Other Enterohemorrhagic E. coli, and the Associated Hemolytic Uremic Syndrome. 

Epidemiologic Reviews 13:60-98.

Health Canada. 2000. Waterborne Outbreak of Gastroenteritis Associated with a Contaminated 

Municipal Water Supply, Walkerton, Ontario, May-June 2000. Canada Communicable Disease 

Report. October 15, 2000. Volume 26-20. pp. 170-173.

Helmi, K., S. Skraber, C. Gantzer, R. Willame, L. Hoffmann, and H.M. Cauchie. 2008. 

Interactions of Cryptosporidium parvum, Giardia lamblia, Vaccinal Poliovirus Type 1, and 

Bacteriophages phiX174 and MS2 with a Drinking Water Biofilm and a Wastewater Biofilm. 

Applied and Environmental Microbiology. 74(7):2079-2088.

Hopkins, R.S., P.M. Shillam, B. Gaspard, L. Eisnach, and R.J. Karlin. 1985. Waterborne Disease 

in Colorado: Three Years’ Surveillance and 18 Outbreaks. Amer. Jour. Public Health. 73(3):254-

257.
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 239 of 325

Hussein, H.S., 2007. Prevalence and pathogenicity of Shiga toxin-producing Escherichia coli in 

beef cattle and their products. Journal of Animal Science. 85 (E. Suppl.):E63-E72.

Kaper, J.B, J.P. Nataro, H.L.T. Mobley, 2004. Pathogenic Escherichia coli. Nature Reviews 

Microbiology 2:123-140.

Kramer, M.H., B.L. Herwaldt, G.F. Craun, R.L. Calderon, and D.D. Juranek, D.D. 1996. 

Waterborne disease: 1993–1994. Journal AWWA. March 1996. pp. 66-80. 

Långmark, J., M.V. Storey, N.J. Ashbolt, and T.A. Stenström. 2007. The effects of UV 

disinfection on distribution pipe biofilm growth and pathogen incidence within the greater 

Stockholm area, Sweden. Water Research 41: 3327-3336.

Lieberman, R.J., Shadix, L.C., Newport, B.S., Crout, S.R., Buescher, S.E., Safferman, R.S., 

Stetler, R.E., Lye, D., Fout, G.S., and Dahling, D. 1994. Source water microbial quality of some 

vulnerable public ground water supplies. In: Proceedings, Water Quality Technology 

Conference. San Francisco, CA. October, 1994.

Lieberman, R., L. Shadix, B. Newport, and C. Frebis. 2002. Microbial Monitoring of Vulnerable 

Public Groundwater Supplies. American Water Works Association Research Foundation, 

Denver, CO. 162 pp.

Livernois, J. 2002. The Economic Costs of the Walkerton Crisis. The Walkerton Inquiry. 

Commissioned Paper 14. Toronto: Ontario Ministry of the Attorney General. 62 pp. 
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 240 of 325

Mead, P.S., L. Slutsker, V. Dietz, L.F. McCaig, J.S. Bresee, C. Shapiro, P.M. Griffin, R.V. 

Tauxe, 1999. Food-Related Illness and Death in the United States. Emerging Infectious Diseases. 

5(5):607-625.

Melnick, J.L. 1996. Enteroviruses: Poliovirus, Coxsackievirus, Echovirus, and Newer 

Enteroviruses. In: Fields Virology, 3rd ed. B.N. Fields, D.M. Knipe, and P.M. Howrey. eds. 

Philadelphia, Lippincott Raven Publishers. pp. 655-712.

Modlin, J.F. 1986. Perinatal Echovirus Infection: Insights from a Literature Review of 61 Cases 

of Serious Infection and 16 Outbreaks in Nurseries. Reviews of Infectious Diseases. 8(6):918-

926.

Modlin, J.F. 1997. Enteroviruses: Coxsackievirus, Cchoviruses and Newer Enteroviruses. In: 

Principles and Practice of Pediatric Infectious Diseases. S.S. Long, et al. eds. New York. 

Churchill Livingston. pp. 1287-1295.

Moorin, R.E., J.S. Heyworth, G. M. Forbes and T.V. Riley. 2010. Long-term health risks for 

children and young adults after infective gastroenteritis. Emerging Infectious Diseases. 

16(9):1440-1447.

NRC (National Research Council). 1997. Safe Water from Every Tap: Improving Water Service 

to Small Communities. National Academy Press. Washington, DC. pp. 28-47.
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 241 of 325

NY State DOH (New York State Department of Health). 2000. The Washington County Fair 

Outbreak Report. New York State Department of Health. Albany, New York. 108 pp.

Olsen, S.J., G. Miller, T. Breuer, M. Kennedy, C. Higgins, J. Walford, G. McKee, K. Fox, W. 

Bibb, and P. Mead. 2002. A Waterborne Outbreak of Escherichia coli O157:H7 Infections and 

Hemolytic Uremic Syndrome: Implications for Rural Water Systems. Emerging Infectious 

Diseases. 8(4):370-375.

OMB (Office of Management and Budget). 1996. Economic Analysis of Federal Regulations 

under Executive Order 12866. January 11, 1996. 

http://www.whitehouse.gov/omb/inforeg_riaguide/ (July 2009). 26 pp.

Parashar, U.D., J.S. Bresee, J.R. Gentsch and R. I. Glass, 1998. Rotavirus, Emerging Infectious 

Diseases 4(4): 561-570.

Parry, S. M., R.L. Salmon. 1998. Sporadic STEC 0157 Infection: Secondary Household 

Transmission in Wales. Emerging Infectious Diseases 4(4): 657-661.

Perz, J.F., F.K. Ennever, and S.M. Le Blancq. 1998. Cryptosporidium in Tap Water; Comparison 

of Predicted Risks with Observed Levels of Disease. Amer. J. Epidem. 147:289-301.

Rangel, J.M., P.H. Sparling, C. Crowe, P.M. Griffin, and D.L. Swerdlow. 2005. Epidemiology of 

Escherichia coli O157:H7 Outbreaks, United States, 1982-2002. Emerging Infectious Diseases. 

11(4):603-609.
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Page 242 of 325

Rose, J.B. 1997. Environmental Ecology of Cryptosporidium and Public Health Implications. 

Annual Rev Public Health. 18:135-161.

SAB (Science Advisory Board). 2010. Review of EPA’s Supporting Analysis for Revisions of 

the Total Coliform Rule. Science Advisory Board Drinking Water Committee. March 19, 2010. 

EPA-SAB-10-004.

Skraber, S., J. Schijven, C. Gantzer, and A.M. de Roda Husman. 2005. Pathogenic viruses in 

drinking-water biofilms: a public health risk? Biofilms. 2:105-117.

Smith, W.G. 1970. Coxsackie B myopericarditis in adults. Am. Heart J. 80(1):34-46.

Swerdlow, D.L., B.A. Woodruff, R.C. Brady, P.M. Griffin, S. Tippen, H. Donnel Jr., E. 

Geldreich, B.J. Payne, A. Meyer Jr., J.G. Wells, K.D. Greene, M. Bright, N.H. Bean, and P.A. 

Blake. 1992. A Waterborne Outbreak in Missouri of Escherichia coli O157:H7 Associated with 

Bloody Diarrhea and Death. Annals of Internal Medicine. 117(10):812-819.

Szewzyk, U., R. Szewzyk, W. Manz, and K.H. Schleifer. 2000. Microbiological safety of 

drinking water. Annual Review of Microbiology 54: 81-127.

USEPA. (United States Environmental Protection Agency). 1989a. Drinking Water; National 

Primary Drinking Water Regulations: Total Coliforms (Including Fecal Coliforms and E. coli); 

Final Rule. 54 FR 27544. (June 29, 1989). 
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USEPA. 1989b. National Primary Drinking Water Regulations: Filtration, Disinfection, 

Turbidity, Giardia lamblia, Viruses, Legionella, and Heterotrophic Bacteria; Final Rule. 54 FR 

27486. (June 29, 1989). 

USEPA. 1998a. National Primary Drinking Water Regulations: Stage 1 Disinfectants and 

Disinfection Byproducts; Final Rule. 63 FR 69389. (December 16, 1998). 

USEPA. 1998b. National Primary Drinking Water Regulations: Interim Enhanced Surface Water 

Treatment Rule; Final Rule. 63 FR 69478. (December 16, 1998).

USEPA. 1999. Drinking Water Criteria Document for Enteroviruses and Hepatitis A: An 

Addendum. January 15, 1999. EPA-822-R-98-043.

USEPA. 2000a. Guidelines for Preparing Economic Analyses. US EPA Office of the 

Administrator. September 2000. EPA-240-R-00-003.

USEPA. 2000b. Health Risks of Enteric Viral Infections in Children. Office of Science and 

Technology, Washington, D.C. September 30, 2000. EPA-822-R-00-010.

USEPA. 2002. National Primary Drinking Water Regulations: Long Term 1 Enhanced Surface 

Water Treatment Rule; Final Rule. 67 FR 1812. (January 14, 2002).

USEPA. 2003. National Primary Drinking Water Regulations: Announcement of Completion of 

EPA’s Review of Existing Drinking Water Standards. 68 FR 42908. (July 18, 2003).
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USEPA. 2006a. Economic Analysis for the Final Ground Water Rule. October 2006. EPA-815-

R-06.014.

USEPA. 2006b. Information Collection Request for Contaminant Occurrence Data in Support of 

EPA's Second Six-Year Review of National Primary Drinking Water Regulations. EPA ICR 

Number 2231.01., OMB Control No. 2040-NEW. August 2006.

USEPA. 2006c. National Primary Drinking Water Regulations: Ground Water Rule; Final Rule. 

71 FR 65574. (November 8, 2006). 

USEPA. 2006d. National Primary Drinking Water Regulations: Long Term 2 Enhanced Surface 

Water Treatment Rule; Final Rule. 71 FR 654. (January 5, 2006).

USEPA. 2006e. National Primary Drinking Water Regulations: Stage 2 Disinfectants and 

Disinfection Byproducts Rule; Final Rule. 71 FR 388. (January 4, 2006).

USEPA. 2007a. Establishment of the Total Coliform Rule Distribution System Advisory 

Committee. 72 FR 35869. (June 29, 2007). 

USEPA. 2007b. The Safe Drinking Water Information System – Federal Version (SDWIS/FED) 

data. Available online at http://epa.gov/enviro/html/sdwis/. Last accessed Apr 2009.

USEPA. 2007c. National Primary Drinking Water Regulations for Lead and Copper: Short-Term 

Regulatory Revisions and Clarifications; Final Rule. 72 FR 57782. (October 10, 2007).
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USEPA. 2008a. Draft Information Collection Request for the Microbial Rules. OMB Control 

Number: 2040-0205. EPA Tracking Number: 1895.06. September 2008.

USEPA. 2008b. Draft Information Collection Request for the Public Water System Supervision 

Program. OMB Control Number: 2040-0090. EPA Tracking Number: 0270.43.

USEPA. 2008c. US Environmental Protection Agency Total Coliform Rule/Distribution Systems 

(TCRDS) Federal Advisory Committee Agreement In Principle. Available online at 

http://www.epa.gov//safewater/disinfection/tcr/pdfs/tcrdsac/agreementinprinciple_tcrdsac_2008-

09-18.pdf. Accessed on June 2009.

USEPA. 2008d. Total Coliform Rule/Distribution System Advisory Committee Meeting, 30-31 

July 2008.

USEPA. 2009. National Primary Drinking Water Regulations: Airline Drinking Water Rule; 

Final Rule. 74 FR 53590. (October 19, 2009).

USEPA. 2010a. National Primary Drinking Water Regulations: Revisions to the Total Coliform 

Rule; Proposed Rule. 75 FR 40926. (July 14, 2010).

USEPA. 2010b. Total Coliform Rule Compliance Monitoring Data Quality and Completion 

Report. EPA-815-R-10-003.
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USEPA. 2010c. Six-Year Review 2 Contaminant Occurrence Data for the Proposed RTCR. 

Available by request at http://www.regulations.gov/ as part of the RTCR docket EPA-HQ-OW2008-0878.

USEPA. 2010d. Proposed Revised Total Coliform Rule Assessments and Corrective Actions 

Guidance Manual, Draft. EPA-815-D-10-001.

USEPA 2012a. Economic Analysis for the Revised Total Coliform Rule. EPA-815-R-XX-XXX.

USEPA. 2012b. Technology and Cost Document for the Revised Total Coliform Rule. EPA-815-

R-XX-XXX.

USEPA. 2012c. Information Collection Request for the Revised Total Coliform Rule. OMB 

Control No. 2040-AD94. EPA ICR No. 1895.06.

World Health Organization (WHO). 2004. Guidelines for Drinking-water Quality 3rd ed. Volume 

1, Recommendations. WHO: Geneva.
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[Title: National Primary Drinking Water Regulation: Revisions to the Total Coliform Rule 

Rule p. 239 of 308]

List of Subjects

40 CFR Part 141

Environmental protection, Chemicals, Incorporation by reference, Indian-lands, 

Intergovernmental relations, Radiation protection, Reporting and recordkeeping requirements, 

Water supply.

40 CFR Part 142

Environmental protection, Administrative practice and procedure, Chemicals, Indian-lands, 

Radiation protection, Reporting and recordkeeping requirements, Water supply.

Dated: ________________________________

______________________________________

Lisa P. Jackson,

Administrator.

For the reasons set forth in the preamble, Title 40 chapter 1 of the Code of Federal Regulations is 

amended as follows:
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PART 141 - NATIONAL PRIMARY DRINKING WATER REGULATIONS

 1. The authority citation for part 141 continues to read as follows:

 Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-4, 300j-9, 

and 300j-11.

2. Section 141.2 is amended by adding, in alphabetical order, definitions for “clean compliance 

history“, “Level 1 assessment“, “Level 2 assessment“, “sanitary defect”, and “seasonal system“ 

to read as follows:

§ 141.2 Definitions.

*****

Clean compliance history is, for the purposes of subpart Y, a record of no MCL violations under 

§ 141.63; no monitoring violations under § 141.21 or subpart Y; and no coliform treatment 

technique trigger exceedances or treatment technique violations under subpart Y.

*****

Level 1 assessment is an evaluation to identify the possible presence of sanitary defects, defects 

in distribution system coliform monitoring practices, and (when possible) the likely reason that 

the system triggered the assessment. It is conducted by the system operator or owner. Minimum 

elements include review and identification of atypical events that could affect distributed water 

quality or indicate that distributed water quality was impaired; changes in distribution system 

maintenance and operation that could affect distributed water quality (including water storage); 
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Page 249 of 325

source and treatment considerations that bear on distributed water quality, where appropriate 

(e.g., whether a ground water system is disinfected); existing water quality monitoring data; and 

inadequacies in sample sites, sampling protocol, and sample processing. The system must 

conduct the assessment consistent with any State directives that tailor specific assessment 

elements with respect to the size and type of the system and the size, type, and characteristics of 

the distribution system.

Level 2 assessment is an evaluation to identify the possible presence of sanitary defects, defects 

in distribution system coliform monitoring practices, and (when possible) the likely reason that 

the system triggered the assessment. A Level 2 assessment provides a more detailed 

examination of the system (including the system’s monitoring and operational practices) than 

does a Level 1 assessment through the use of more comprehensive investigation and review of 

available information, additional internal and external resources, and other relevant practices. It 

is conducted by an individual approved by the State, which may include the system operator. 

Minimum elements include review and identification of atypical events that could affect 

distributed water quality or indicate that distributed water quality was impaired; changes in 

distribution system maintenance and operation that could affect distributed water quality 

(including water storage); source and treatment considerations that bear on distributed water 

quality, where appropriate (e.g., whether a ground water system is disinfected); existing water 

quality monitoring data; and inadequacies in sample sites, sampling protocol, and sample 

processing. The system must conduct the assessment consistent with any State directives that 

tailor specific assessment elements with respect to the size and type of the system and the size, 

type, and characteristics of the distribution system. The system must comply with any expedited 

actions or additional actions required by the State in the case of an E. coli MCL violation. 

Comment [EPA219]: This is 

consistent with the AIP, proposal, and 

public comments. There is a special 

primacy condition (see 

142.16(q)(2)(iii)(A) and (C) that 

allows the state to develop its own 

approach, using existing processes 

where available. We have also 

developed an assessment and 

corrective action guidance manual that 

will be finalized shortly after 

promulgation.

Comment [JL220]: This seems to be 

the only concrete diff from a level 1 

assessment. These defs do not really 

make clear how the level 2 assessment 

is to be more comprehensive.

EPA - discussed the differences with 

OMB. Assessment and corrective 

action guidance will provide further 

distinction between the two levels. 

States will have the flexibility to 

design the inspections to meet their 

own needs.
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*****

Sanitary defect is a defect that could provide a pathway of entry for microbial contamination into 

the distribution system or that is indicative of a failure or imminent failure in a barrier that is 

already in place. 

*****

Seasonal system is a non-community water system that is not operated as a public water system 

on a year-round basis and starts up and shuts down at the beginning and end of each operating 

season. 

*****

 3. Section 141.4 is revised to read as follows: 

§ 141.4 Variances and exemptions.

(a) Variances or exemptions from certain provisions of these regulations may be granted 

pursuant to sections 1415 and 1416 of the Act and subpart K of part 142 of this chapter (for 

small system variances) by the entity with primary enforcement responsibility, except that 

variances or exemptions from the MCLs for total coliforms and E. coli and variances from any of 

the treatment technique requirements of subpart H of this part may not be granted.

(b) EPA has stayed the effective date of this section relating to the total coliform MCL of 

§141.63(a) for systems that demonstrate to the State that the violation of the total coliform MCL 

is due to a persistent growth of total coliforms in the distribution system rather than fecal or 

pathogenic contamination, a treatment lapse or deficiency, or a problem in the operation or 

maintenance of the distribution system. This is stayed until [DATE THREE YEARS AFTER
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PUBLICATION OF THE FINAL RULE]March 31, 2016, at which time the total coliform 

MCL is no longer effective. 

NOTE TO PARAGRAPH (a): As provided in § 142.304(a), small system variances are not 

available for rules addressing microbial contaminants, which would include subparts H, P, S, T, 

W, and Y of this part.

 4. Section 141.21 is amended by adding paragraph (h) to read as follows:

§ 141.21 Coliform sampling.

*****

 (h) The provisions of paragraphs (a) and (d) are applicable until March 31, 2016[DATE 

THREE YEARS AFTER PUBLICATION OF THE FINAL RULE]. The provisions of 

paragraphs (b), (c), (e), (f), and (g) are applicable until all required repeat monitoring under 

paragraph (b) and fecal coliform or E. coli testing under paragraph (e) that was initiated by a 

total coliform-positive sample taken before April 1, 2016[DATE THREE YEARS AFTER

PUBLICATION OF THE FINAL RULE] is completed, as well as analytical method, 

reporting, recordkeeping, public notification, and consumer confidence report requirements 

associated with that monitoring and testing. After Beginning April 1, 2016[DATE THREE 

YEARS AFTER PUBLICATION OF THE FINAL RULE], the provisions of subpart Y of 

this part are applicable, with systems required to begin regular monitoring at the same frequency 

as the system-specific frequency required on March 31, 2016[DATE THREE YEARS AFTER

PUBLICATION OF THE FINAL RULE]. 

Comment [EPA221]: EPA ok with 

the OMB insertion.
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 5. Section 141.52 is revised to read as follows:

§ 141.52 Maximum contaminant level goals for microbiological contaminants.

 (a) MCLGs for the following contaminants are as indicated:

Contaminant MCLG

(1) Giardia lamblia ........................................ zero

(2) Viruses .................................................... zero

(3) Legionella ................................................ zero

(4) Total coliforms (including fecal............zero 

coliforms and Escherichia coli)

(5) Cryptosporidium ...................................... zero

(6) Escherichia coli (E. coli).....................zero

 (b) The MCLG identified in paragraph (a)(4) of this section is applicable until March 31, 

2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE]. The 

MCLG identified in paragraph (a)(6) of this section is applicable beginning April 1, 2016

[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE]. 

 6. Section 141.63 is revised to read as follows: 

§ 141.63 Maximum contaminant levels (MCLs) for microbiological contaminants.
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(a) Until March 31, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL 

RULE], the total coliform MCL is based on the presence or absence of total coliforms in a 

sample, rather than coliform density.

(1) For a system that collects at least 40 samples per month, if no more than 5.0 percent of the 

samples collected during a month are total coliform-positive, the system is in compliance with 

the MCL for total coliforms.

(2) For a system that collects fewer than 40 samples per month, if no more than one sample 

collected during a month is total coliform-positive, the system is in compliance with the MCL for 

total coliforms.

(b) Until March 31, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL 

RULE], any fecal coliform-positive repeat sample or E. coli-positive repeat sample, or any total 

coliform-positive repeat sample following a fecal coliform-positive or E. coli-positive routine 

sample, constitutes a violation of the MCL for total coliforms. For purposes of the public 

notification requirements in subpart Q of this part, this is a violation that may pose an acute risk 

to health. 

(c) Beginning April 1, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE 

FINAL RULE], a system is in compliance with the MCL for E. coli for samples taken under the 

provisions of subpart Y of this part unless any of the conditions identified in paragraphs (c)(1) 

through (c)(4) of this section occur. For purposes of the public notification requirements in 

subpart Q of this part, violation of the MCL may pose an acute risk to health. 

(1) The system has an E. coli-positive repeat sample following a total coliform-positive routine 

sample.
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(2) The system has a total coliform-positive repeat sample following an E. coli-positive routine 

sample.

(3) The system fails to take all required repeat samples following an E. coli-positive routine 

sample.

(4) The system fails to test for E. coli when any repeat sample tests positive for total coliform.

(d) Until March 31, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL 

RULE], a public water system must determine compliance with the MCL for total coliforms in 

paragraphs (a) and (b) of this section for each month in which it is required to monitor for total 

coliforms. Beginning April 1, 2016[DATE THREE YEARS AFTER PUBLICATION OF 

THE FINAL RULE], a public water system must determine compliance with the MCL for E. 

coli in paragraph (c) of this section for each month in which it is required to monitor for total 

coliforms.

(e) The Administrator, pursuant to section 1412 of the Act, hereby identifies the following as the 

best technology, treatment techniques, or other means available for achieving compliance with 

the maximum contaminant level for total coliforms in paragraphs (a) and (b) of this section and 

for achieving compliance with the maximum contaminant level for E. coli in paragraph (c) of 

this section:

(1) Protection of wells from fecal contamination by appropriate placement and construction;

(2) Maintenance of a disinfectant residual throughout the distribution system;

(3) Proper maintenance of the distribution system including appropriate pipe replacement and 

repair procedures, main flushing programs, proper operation and maintenance of storage tanks 

and reservoirs, cross connection control, and continual maintenance of positive water pressure in 

all parts of the distribution system;
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(4) Filtration and/or disinfection of surface water, as described in subparts H, P, T, and W of this 

part, or disinfection of ground water, as described in subpart S of this part, using strong oxidants 

such as chlorine, chlorine dioxide, or ozone; and

(5) For systems using ground water, compliance with the requirements of an EPA-approved State 

Wellhead Protection Program developed and implemented under section 1428 of the SDWA.

(f) The Administrator, pursuant to section 1412 of the Act, hereby identifies the technology, 

treatment techniques, or other means available identified in paragraph (e) of this section as 

affordable technology, treatment techniques, or other means available to systems serving 10,000 

or fewer people for achieving compliance with the maximum contaminant level for total 

coliforms in paragraphs (a) and (b) of this section and for achieving compliance with the 

maximum contaminant level for E. coli in paragraph (c) of this section.

7. Section 141.71 is amended by revising paragraph (b)(5) to read as follows: 

§ 141.71 Criteria for avoiding filtration.

*****

(b) ***

(5) The public water system must comply with the maximum contaminant level (MCL) for total 

coliforms in § 141.63(a) and (b) and the MCL for E. coli in § 141.63(c) at least 11 months of the 

12 previous months that the system served water to the public, on an ongoing basis, unless the 

State determines that failure to meet this requirement was not caused by a deficiency in treatment 

of the source water.

Comment [JL222]: Should you 

specify that this goes away after three 

years?

Comment [EPA223]: We have relied 

on the expiration already specified in 

those paragraphs (as well as the start 

date specified for the E coli MCL in 

141.63(c)).
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

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 8. Section 141.74 is amended by revising paragraphs (b)(6)(i) and (c)(3)(i) to read as follows: 

§ 141.74 Analytical and monitoring requirements.

*****

(b) ***

(6)(i) Until March 31, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE 

FINAL RULE], the residual disinfectant concentration must be measured at least at the same 

points in the distribution system and at the same time as total coliforms are sampled, as specified 

in § 141.21. Beginning April 1, 2016[DATE THREE YEARS AFTER PUBLICATION OF 

THE FINAL RULE], the residual disinfectant concentration must be measured at least at the 

same points in the distribution system and at the same time as total coliforms are sampled, as 

specified in §§ 141.854 through 141.858. The State may allow a public water system which uses 

both a surface water source or a ground water source under direct influence of surface water, and 

a ground water source, to take disinfectant residual samples at points other than the total coliform 

sampling points if the State determines that such points are more representative of treated 

(disinfected) water quality within the distribution system. Heterotrophic bacteria, measured as 

heterotrophic plate count (HPC) as specified in paragraph (a)(1) of this section, may be measured 

in lieu of residual disinfectant concentration.

*****

(c) ***

(3)(i) Until March 31, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE 

FINAL RULE], the residual disinfectant concentration must be measured at least at the same 

points in the distribution system and at the same time as total coliforms are sampled, as specified 
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in § 141.21. Beginning April 1, 2016[DATE THREE YEARS AFTER PUBLICATION OF 

THE FINAL RULE], the residual disinfectant concentration must be measured at least at the 

same points in the distribution system and at the same time as total coliforms are sampled, as 

specified in §§ 141.854 through 141.858. The State may allow a public water system which uses 

both a surface water source or a ground water source under direct influence of surface water, and 

a ground water source, to take disinfectant residual samples at points other than the total coliform 

sampling points if the State determines that such points are more representative of treated 

(disinfected) water quality within the distribution system. Heterotrophic bacteria, measured as 

heterotrophic plate count (HPC) as specified in paragraph (a)(1) of this section, may be measured 

in lieu of residual disinfectant concentration.

*****

 9. Section 141.132 is amended by revising paragraph (c)(1)(i) to read as follows: 

§ 141.132 Monitoring requirements.

*****

(c) ***

(1) ***

(i) Routine monitoring. Until March 31, 2016[DATE THREE YEARS AFTER

PUBLICATION OF THE FINAL RULE], community and non-transient non-community 

water systems that use chlorine or chloramines must measure the residual disinfectant level in the 

distribution system at the same point in the distribution system and at the same time as total 

coliforms are sampled, as specified in § 141.21. Beginning April 1, 2016[DATE THREE 
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Page 258 of 325

YEARS AFTER PUBLICATION OF THE FINAL RULE], community and non-transient 

non-community water systems that use chlorine or chloramines must measure the residual 

disinfectant level in the distribution system at the same point in the distribution system and at the 

same time as total coliforms are sampled, as specified in §§ 141.854 through 141.858. Subpart H 

systems of this part may use the results of residual disinfectant concentration sampling 

conducted under § 141.74(b)(6)(i) for unfiltered systems or § 141.74(c)(3)(i) for systems which 

filter, in lieu of taking separate samples.

*****

10. Section 141.153 is amended as follows:

(a). By adding paragraphs (c)(4)(i) and (ii);,

(b.) By revising paragraph (d)(4)(iv) introductory text,

c. By revising paragraph (d)(4)(vii) introductory text;,

(cd). By revising paragraph (d)(4)(viii),,

(de). By adding paragraph (d)(4)(x);, and 

(ef). By adding paragraph (h)(7).

§ 141.153 Content of the reports.

*****

(c)***

(4) A report that contains information regarding a Level 1 or Level 2 Assessment required under 

Subpart Y of this part must include the applicable definitions: (i) Level 1 Assessment: A Level 1 

Comment [JRJ224]: Changes to 

amendatory language are a result of 

OP’s review
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 259 of 325

assessment is a study of the water system to identify potential problems and determine (if 

possible) why total coliform bacteria have been found in our water system.

(ii) Level 2 Assessment: A Level 2 assessment is a very detailed study of the water system to 

identify potential problems and determine (if possible) why an E. coli MCL violation has 

occurred and/or why total coliform bacteria have been found in our water system on multiple 

occasions.

(d) ***

(4) *** 

(iv) For contaminants subject to an MCL, except turbidity, total coliform, fecal coliform and E. 

coli, the highest contaminant level used to determine compliance with an NPDWR and the range 

of detected levels, as follows:

*****

(vii) For total coliform analytical results until March 31, 2016[DATE THREE YEARS AFTER

PUBLICATION OF THE FINAL RULE]:

*****

(viii) For fecal coliform and E. coli until March 31, 2016[DATE THREE YEARS AFTER

PUBLICATION OF THE FINAL RULE]: The total number of positive samples;

*****

(x) For E. coli analytical results under subpart Y: The total number of positive samples.

*****

(h)*** 
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(7) Systems required to comply with subpart Y. (i) Any system required to comply with the 

Level 1 assessment requirement or a Level 2 assessment requirement that is not due to an E. coli

MCL violation must include in the report the text found in paragraph (h)(7)(i)(A) and paragraphs 

(h)(7)(i)(B) and (C) of this section as appropriate, filling in the blanks accordingly and the text 

found in paragraphs (h)(7)(i)(D)(1) and (2) of this section if appropriate. 

(A) Coliforms are bacteria that are naturally present in the environment and are used as an 

indicator that other, potentially harmful, waterborne pathogens may be present or that a potential 

pathway exists through which contamination may enter the drinking water distribution system. 

We found coliforms indicating the need to look for potential problems in water treatment or 

distribution. When this occurs, we are required to conduct assessment(s) to identify problems 

and to correct any problems that were found during these assessments. 

(B) During the past year we were required to conduct [INSERT NUMBER OF LEVEL 

1ASSESSMENTS] Level 1 assessment(s). [INSERT NUMBER OF LEVEL 1 ASSESSMENTS]

Level 1 assessment(s) were completed. In addition, we were required to take [INSERT NUMBER 

OF CORRECTIVE ACTIONS] corrective actions and we completed [INSERT NUMBER OF 

CORRECTIVE ACTIONS] of these actions.

(C) During the past year [INSERT NUMBER OF LEVEL 2 ASSESSMENTS] Level 2 assessments 

were required to be completed for our water system. [INSERT NUMBER OF LEVEL 2 

ASSESSMENTS] Level 2 assessments were completed. In addition, we were required to take 

[INSERT NUMBER OF CORRECTIVE ACTIONS] corrective actions and we completed [INSERT 

NUMBER OF CORRECTIVE ACTIONS] of these actions. 
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(D) Any system that has failed to complete all the required assessments or correct all identified 

sanitary defects, is in violation of the treatment technique requirement and must also include one 

or both of the following statements, as appropriate:

(1) During the past year we failed to conduct all of the required assessment(s).

(2) During the past year we failed to correct all identified defects that were found during the 

assessment.

(ii) Any system required to conduct a Level 2 assessment due to an E. coli MCL violation must 

include in the report the text found in paragraphs (h)(7)(ii)(A) and (B) of this section, filling in 

the blanks accordingly and the text found in paragraphs (h)(7)(ii)(C)(1) and (2) of this section, if 

appropriate.

(A) E. coli are bacteria whose presence indicates that the water may be contaminated with human 

or animal wastes. Human pathogens in these wastes can cause short-term effects, such as 

diarrhea, cramps, nausea, headaches, or other symptoms. They may pose a greater health risk for 

infants, young children, the elderly, and people with severely compromised immune systems. 

We found E. coli bacteria, indicating the need to look for potential problems in water treatment 

or distribution. When this occurs, we are required to conduct assessment(s) to identify problems 

and to correct any problems that were found during these assessments. 

(B) We were required to complete a Level 2 assessment because we found E. coli in our water 

system. In addition, we were required to take [INSERT NUMBER OF CORRECTIVE 

ACTIONS] corrective actions and we completed [INSERT NUMBER OF CORRECTIVE 

ACTIONS] of these actions.
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(C) Any system that has failed to complete the required assessment or correct all identified 

sanitary defects, is in violation of the treatment technique requirement and must also include one 

or both of the following statements, as appropriate:

(1) We failed to conduct the required assessment.

(2) We failed to correct all sanitary defects that were identified during the assessment that we 

conducted.

(iii) If a system detects E. coli and has violated the E. coli MCL, in addition to completing the 

table as required in paragraph (d)(4) of this section, the system must include one or more of the 

following statements to describe any noncompliance, as applicable:

(A) We had an E. coli-positive repeat sample following a total coliform-positive routine sample.

(B) We had a total coliform-positive repeat sample following an E. coli-positive routine sample.

(C) We failed to take all required repeat samples following an E. coli-positive routine sample.

(D) We failed to test for E. coli when any repeat sample tests positive for total coliform.

(iv) If a system detects E. coli and has not violated the E. coli MCL, in addition to completing the 

table as required in paragraph (d)(4) of this section, the system may include a statement that 

explains that although they have detected E. coli, they are not in violation of the E. coli MCL.

11. In Appendix A to Subpart O of Part 141 is amended as follows:

a. By , the table is amended by revising the entries for “Total Coliform Bacteria” and “Fecal 

Coliform and E. coli,”

b. By adding a second entry for “Total Coliform Bacteria,” 

c. By adding as a fourth entry “E. coli,” and 

d. By adding two endnotes, to read as follows: before Endnote 1.
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APPENDIX A TO SUBPART O OF PART 141 – REGULATED CONTAMINANTS

Contaminant 

(units)

Traditional 

MCL in mg/L

To 

convert 

for 

CCR, 

multiply 

by

MCL in 

CCR 

units MCLG

Major 

sources in 

drinking 

water

Health effects 

language

Microbiological 

contaminants:

Total 

Coliform 

Bacteria †

MCL (systems 

that collect ≥40 

samples/month) 

5% of monthly

samples are 

positive; 

(systems that 

collect <40 

samples/month) 

1 positive 

monthly sample

........ MCL 

(systems 

that 

collect 

≥40 

samples/

month) 

5% of 

monthly 

samples 

are 

positive; 

(systems 

that 

collect 

<40 

samples/

month) 

1 

positive 

monthly 

sample.

0 Naturally

present in the 

environment

Coliforms are 

bacteria that are 

naturally present in 

the environment and 

are used as an 

indicator that other, 

potentially-harmful, 

bacteria may be 

present. Coliforms 

were found in more 

samples than allowed 

and this was a 

warning of potential 

problems.

Total 

Coliform 

Bacteria ‡

TT TT N/A Naturally 

present in the 

environment

Use language found 

in 

§141.153(h)(7)(i)(A)

Fecal 

coliform and 

E. coli †

0 ......... 0 0 Human and 

animal fecal 

waste

Fecal coliforms and 

E. coli are bacteria 

whose presence 

indicates that the 

water may be 

contaminated with 
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Page 264 of 325

human or animal 

wastes. Microbes in 

these wastes can 

cause short-term 

effects, such as 

diarrhea, cramps, 

nausea, headaches, or 

other symptoms. 

They may pose a 

special health risk for 

infants, young 

children, some of the 

elderly, and people 

with severely 

compromised 

immune systems.

E. coli ‡ Routine and 

repeat samples 

are total 

coliformpositive and 

either is E. colipositive or 

system fails to 

take repeat 

samples 

following E. 

coli-positive 

routine sample 

or system fails 

to analyze total 

coliformpositive repeat 

sample for E. 

coli

...... Routine 

and 

repeat 

samples 

are total 

coliform

-positive 

and 

either is 

E. colipositive 

or 

system 

fails to 

take 

repeat 

samples 

followin

g E. 

colipositive 

routine 

sample 

or 

system 

fails to 

analyze 

0 Human and 

animal fecal 

waste

E. coli are bacteria 

whose presence 

indicates that the 

water may be 

contaminated with 

human or animal 

wastes. Human 

pathogens in these 

wastes can cause 

short-term effects, 

such as diarrhea, 

cramps, nausea, 

headaches, or other 

symptoms. They may 

pose a greater health 

risk for infants, 

young children, the 

elderly, and people 

with severelycompromised 

immune systems.
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 265 of 325

total 

coliform

-positive 

repeat 

sample 

for E. 

coli

* * * * * * *

*****

† Until March 31, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL 

RULE].

‡ Beginning April 1, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE 

FINAL RULE].

*****

 12. Section 141.202(a), Table 1, is amended by adding one sentence at the end of entry one (1) 

to read as follows:

§ 141.202 Tier 1 Public Notice – Form, manner, and frequency of notice.

*****

Table 1 to § 141.202 – Violation Categories and Other Situations Requiring A Tier 1 Public 

Notice

(1) ***

Violation of the MCL for E. coli (as specified in §141.63(c));

* * * * * * *

 13. Section 141.203(b)(2) is revised to read as follows:

§ 141.203 Tier 2 Public Notice – Form, manner, and frequency of notice. 

*****
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(b) ***

(2) The public water system must repeat the notice every three months as long as the violation or 

situation persists, unless the primacy agency determines that appropriate circumstances warrant a 

different repeat notice frequency. In no circumstance may the repeat notice be given less 

frequently than once per year. It is not appropriate for the primacy agency to allow less frequent 

repeat notice for an MCL or treatment technique violation under the Total Coliform Rule or 

subpart Y of this part or a treatment technique violation under the Surface Water Treatment Rule 

or Interim Enhanced Surface Water Treatment Rule. It is also not appropriate for the primacy 

agency to allow through its rules or policies across-the-board reductions in the repeat notice 

frequency for other ongoing violations requiring a Tier 2 repeat notice. Primacy agency 

determinations allowing repeat notices to be given less frequently than once every three months 

must be in writing.

*****

 14. Section 141.204(a), Table 1, is amended by revising entries (4) and (5) and adding entry (6) 

to read as follows:

§ 141.204 Tier 3 Public Notice – Form, manner, frequency of notice.

(a) ***

Table 1 to § 141.204 – Violation Categories and Other Situations Requiring a Tier 3 Public 

Notice

* * * * * * *

(4) Availability of unregulated contaminant monitoring results, as required under § 141.207; 

(5) Exceedance of the fluoride secondary maximum contaminant level (SMCL), as required 

under § 141.208; and
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(6) Reporting and Recordkeeping violations under subpart Y of 40 CFR part 141.

*****

 15. Appendix A to subpart Q of Part 141 is amended as follows:

a. by rBy revising entries I.A.1 and I.A.2,

b. By adding two endnotes before Endnote 1, and

c. By modifying Endnote 1.

and adding two endnotes to read as follows:

APPENDIX A TO SUBPART Q OF PART 141 – NPDWR VIOLATIONS AND OTHER 

SITUATIONS REQUIRING PUBLIC NOTICE1

Contaminant MCL/MRDL/TT 

violations2

Monitoring, testing & 

reporting procedure 

violations

Tier of 

public 

notice 

required Citation

Tier of 

public 

notice 

required Citation

I. Violations of National Primary Drinking 

Water Regulations (NPDWR):3

A. Microbiological Contaminants

1.a Total coliform bacteria † 2 141.63(a) 3 141.21(a)-(e)

1.b Total coliform (Monitoring or TT 

violations resulting from failure to 

perform assessments or corrective 

actions) ‡

2 141.860(b) 3 141.860(c)

1.c Seasonal system failure to follow 

State-approved start-up plan prior to 

serving water to the public. ‡

2 141.860(b)(2)

2.a Fecal coliform/E. coli † 1 141.63(b) 4

1,3 141.21(e)

2.b E. coli ‡ 1 141.860 (a) 3 141.860(c)

141.860(d)(2)

2.c E.coli (TT violations resulting 141.860(b) 
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

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from failure to perform level 2 

Assessments or corrective action) ‡

2

* * * * * * *

Appendix A—Endnotes

† Until March 31, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL 

RULE].

‡ Beginning [DATE THREE YEARS AFTER PUBLICATION OF THE FINAL 

RULE]April 1, 2016.

1. Violations and other situations not listed in this table (e.g., failure to prepare Consumer 

Confidence Reports), do not require notice, unless otherwise determined by the primacy agency. 

Primacy agencies may, at their option, also require a more stringent public notice tier (e.g., Tier 

1 instead of Tier 2 or Tier 2 instead of Tier 3) for specific violations and situations listed in this 

Appendix, as authorized under § 141.202(a) and § 141.203(a).

2. MCL – Maximum contaminant level, MRDL – Maximum residual disinfectant level, TT –

Treatment technique

3. The term Violations of National Primary Drinking Water Regulations (NPDWR) is used here 

to include violations of MCL, MRDL, treatment technique, monitoring, and testing procedure 

requirements.

4. Failure to test for fecal coliform or E. coli is a Tier 1 violation if testing is not done after any 

repeat sample tests positive for coliform. All other total coliform monitoring and testing 

procedure violations are Tier 3.

† Until [DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE].

‡ Beginning [DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE].

*****

 16. Appendix B to subpart Q of Part 141 is amended as follows:

(a). By revising entries 1a and 1b;,

(b). By adding entries 1e, 1f, 1g and 1h;, and

Comment [JRJ225]: Changes to the 

location of these endnotes and how 

they are described in the amendatory 

language are a result of OP’s review.
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 269 of 325

(c). By adding two endnotes before Endnote 1.

APPENDIX B TO SUBPART Q OF PART 141 – STANDARD HEALTH EFFECTS

LANGUAGE FOR PUBLIC NOTIFICATION

Contaminant MCLG1mg/L MCL2mg/L

Standard health effects language for 

public notification

National Primary Drinking Water Regulations (NPDWR)

A. Microbiological Contaminants

1a. Total coliform 

†

Zero See footnote 3 Coliforms are bacteria that are naturally 

present in the environment and are used as 

an indicator that other, potentiallyharmful, bacteria may be present. 

Coliforms were found in more samples 

than allowed and this was a warning of 

potential problems.

1b. Fecal 

coliform/E. coli †

Zero Zero Fecal coliforms and E. coli are bacteria 

whose presence indicates that the water 

may be contaminated with human or 

animal wastes. Microbes in these wastes 

can cause short-term effects, such as 

diarrhea, cramps, nausea, headaches, or 

other symptoms. They may pose a special 

health risk for infants, young children, 

some of the elderly, and people with 

severely compromised immune systems.

 * * * * * * *

1e. Subpart Y 

Coliform 

Assessment and/or 

Corrective Action 

Violations ‡

N/A TT3 Coliforms are bacteria that are naturally 

present in the environment and are used as 

an indicator that other, potentially 

harmful, waterborne pathogens may be 

present or that a potential pathway exists 

through which contamination may enter 

the drinking water distribution system. 

We found coliforms indicating the need to 

look for potential problems in water 

treatment or distribution. When this 

occurs, we are required to conduct 

assessments to identify problems and to 

correct any problems that are found. 

[THE SYSTEM MUST USE THE 

FOLLOWING APPLICABLE 

SENTENCES.] 
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We failed to conduct the required 

assessment.

We failed to correct all identified sanitary 

defects that were found during the 

assessment(s).

1f. Subpart Y 

E.coli Assessment 

and/or Corrective 

Action Violations 

‡

N/A TT3 E. coli are bacteria whose presence 

indicates that the water may be 

contaminated with human or animal 

wastes. Human pathogens in these wastes 

can cause short-term effects, such as 

diarrhea, cramps, nausea, headaches, or 

other symptoms. They may pose a greater 

health risk for infants, young children, the 

elderly, and people with severely 

compromised immune systems. We 

violated the standard for E. coli, 

indicating the need to look for potential 

problems in water treatment or 

distribution. When this occurs, we are 

required to conduct a detailed assessment 

to identify problems and to correct any 

problems that are found. 

[THE SYSTEM MUST USE THE 

FOLLOWING APPLICABLE 

SENTENCES.] 

We failed to conduct the required 

assessment.

We failed to correct all identified sanitary 

defects that were found during the 

assessment that we conducted.

1g. E. coli ‡ Zero In compliance 

unless one of the 

following 

conditions occurs:

(1) The system has 

an E. coli-positive 

repeat sample 

following a total 

coliform-positive 

routine sample.

(2) The system has 

a total coliformpositive repeat 

sample following 

an E. coli-positive 

E. coli are bacteria whose presence 

indicates that the water may be 

contaminated with human or animal 

wastes. Human pathogens in these wastes 

can cause short-term effects, such as 

diarrhea, cramps, nausea, headaches, or 

other symptoms. They may pose a greater 

health risk for infants, young children, the 

elderly, and people with severely 

compromised immune systems.
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routine sample.

(3) The system fails 

to take all required 

repeat samples 

following an E. 

coli-positive 

routine sample.

(4) The system fails 

to test for E. coli

when any repeat 

sample tests 

positive for total 

coliform.

1h. Subpart Y 

Seasonal System 

TT Violations ‡

N/A TT3 When this violation includes the failure to 

monitor for total coliforms or E. coli prior 

to serving water to the public, the 

mandatory language found at 

141.205(d)(2) must be used.

When this violation includes failure to 

complete other actions, the appropriate 

elements found in 141.205(a) to describe 

the violation must be used. 

 * * * * * * *

Appendix B—Endnotes

1. MCLG – Maximum contaminant level goal

2. MCL – Maximum contaminant level

3. For water systems analyzing at least 40 samples per month, no more than 5.0 percent of the 

monthly samples may be positive for total coliforms. For systems analyzing fewer than 40 

samples per month, no more than one sample per month may be positive for total coliforms.

† Until March 31, 2016.[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL 

RULE]

‡ Beginning April 1, 2016.[DATE THREE YEARS AFTER PUBLICATION OF THE 

FINAL RULE]

*****
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17. Section 141.402 is amended by revising paragraph (a) to read as follows:

§ 141.402 Ground water source microbial monitoring and analytical methods.

(a) Triggered source water monitoring—

(1) General requirements. A ground water system must conduct triggered source water 

monitoring if the conditions identified in paragraphs (a)(1)(i) and either (a)(1)(ii) or (a)(1)(iii) of 

this section exist.

(i) The system does not provide at least 4-log treatment of viruses (using inactivation, removal, 

or a State-approved combination of 4-log virus inactivation and removal) before or at the first 

customer for each ground water source; and either

(ii) The system is notified that a sample collected under § 141.21(a) is total coliform-positive and 

the sample is not invalidated under § 141.21(c) until March 31, 2016[DATE THREE YEARS 

AFTER PUBLICATION OF THE FINAL RULE], or 

(iii) The system is notified that a sample collected under §§ 141.854 through 141.857 is total 

coliform-positive and the sample is not invalidated under § 141.853(c) beginning April 1, 

2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE].

(2) Sampling requirements. A ground water system must collect, within 24 hours of notification 

of the total coliform-positive sample, at least one ground water source sample from each ground 

water source in use at the time the total coliform-positive sample was collected under § 141.21(a)

until March 31, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL 

RULE], or collected under §§ 141.854 through 141.857 beginning April 1, 2016[DATE 

THREE YEARS AFTER PUBLICATION OF THE FINAL RULE], except as provided in 

paragraph (a)(2)(ii) of this section.
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(i) The State may extend the 24-hour time limit on a case-by-case basis if the system cannot 

collect the ground water source water sample within 24 hours due to circumstances beyond its 

control. In the case of an extension, the State must specify how much time the system has to 

collect the sample.

(ii) If approved by the State, systems with more than one ground water source may meet the 

requirements of this paragraph (a)(2) by sampling a representative ground water source or 

sources. If directed by the State, systems must submit for State approval a triggered source water 

monitoring plan that identifies one or more ground water sources that are representative of each 

monitoring site in the system’s sample siting plan under § 141.21(a) until March 31, 

2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE], or under § 

141.853 beginning April 1, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE 

FINAL RULE], and that the system intends to use for representative sampling under this 

paragraph.

(iii) Until March 31, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE 

FINAL RULE], a ground water system serving 1,000 or fewer people may use a repeat sample 

collected from a ground water source to meet both the requirements of § 141.21(b) and to satisfy 

the monitoring requirements of paragraph (a)(2) of this section for that ground water source only 

if the State approves the use of E. coli as a fecal indicator for source water monitoring under this 

paragraph (a). If the repeat sample collected from the ground water source is E. coli-positive, the 

system must comply with paragraph (a)(3) of this section.

(iv) Beginning April 1, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE 

FINAL RULE], a ground water system serving 1,000 or fewer people may use a repeat sample 

collected from a ground water source to meet both the requirements of subpart Y and to satisfy 
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the monitoring requirements of paragraph (a)(2) of this section for that ground water source only 

if the State approves the use of E. coli as a fecal indicator for source water monitoring under this 

paragraph (a) and approves the use of a single sample for meeting both the triggered source 

water monitoring requirements in this paragraph (a) and the repeat monitoring requirements in § 

141.858. If the repeat sample collected from the ground water source is E. coli- positive, the 

system must comply with paragraph (a)(3) of this section.

(3) Additional requirements. If the State does not require corrective action under § 

141.403(a)(2) for a fecal indicator-positive source water sample collected under paragraph (a)(2) 

of this section that is not invalidated under paragraph (d) of this section, the system must collect 

five additional source water samples from the same source within 24 hours of being notified of 

the fecal indicator-positive sample. 

(4) Consecutive and wholesale systems—

(i) In addition to the other requirements of this paragraph (a), a consecutive ground water system 

that has a total coliform-positive sample collected under § 141.21(a) until March 31, 

2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE], or under 

§§ 141.854 through 141.857 beginning April 1, 2016[DATE THREE YEARS AFTER

PUBLICATION OF THE FINAL RULE], must notify the wholesale system(s) within 24 

hours of being notified of the total coliform-positive sample.

(ii) In addition to the other requirements of this paragraph (a), a wholesale ground water system 

must comply with paragraphs (a)(4)(ii)(A) and (a)(4)(ii)(B) of this section.

(A) A wholesale ground water system that receives notice from a consecutive system it serves 

that a sample collected under § 141.21(a) until March 31, 2016[DATE THREE YEARS 

AFTER PUBLICATION OF THE FINAL RULE], or collected under §§ 141.854 through 
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141.857 beginning April 1, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE 

FINAL RULE], is total coliform-positive must, within 24 hours of being notified, collect a 

sample from its ground water source(s) under paragraph(a)(2) of this section and analyze it for a 

fecal indicator under paragraph (c) of this section.

(B) If the sample collected under paragraph (a)(4)(ii)(A) of this section is fecal indicatorpositive, the wholesale ground water system must notify all consecutive systems served by that 

ground water source of the fecal indicator source water positive within 24 hours of being notified 

of the ground water source sample monitoring result and must meet the requirements of 

paragraph (a)(3) of this section.

(5) Exceptions to the triggered source water monitoring requirements. A ground water system is 

not required to comply with the source water monitoring requirements of paragraph (a) of this 

section if either of the following conditions exists:

(i) The State determines, and documents in writing, that the total coliform-positive sample 

collected under § 141.21(a) until March 31, 2016[DATE THREE YEARS AFTER

PUBLICATION OF THE FINAL RULE], or under §§ 141.854 through 141.857 beginning

April 1, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE], is 

caused by a distribution system deficiency; or

(ii) The total coliform-positive sample collected under § 141.21(a) until March 31, 2016[DATE 

THREE YEARS AFTER PUBLICATION OF THE FINAL RULE], or under §§ 141.854 

through 141.857 beginning April 1, 2016[DATE THREE YEARS AFTER PUBLICATION 

OF THE FINAL RULE], is collected at a location that meets State criteria for distribution 

system conditions that will cause total coliform-positive samples.

*****
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18. Section 141.405 is amended by revising paragraph (b)(4) to read as follows:

§ 141.405 Reporting and recordkeeping for ground water systems.

*****

(b) ***

(4) For consecutive systems, documentation of notification to the wholesale system(s) of total 

coliform-positive samples that are not invalidated under § 141.21(c) until March 31, 

2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE], or under § 

141.853 beginning April 1, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE 

FINAL RULE]. Documentation shall be kept for a period of not less than five years.

*****

19. Section 141.803 is amended by revising paragraphs (a)(3) and (a)(5) to read as follows:

§ 141.803 Coliform sampling.

(a) ***

(3) Air carriers must conduct analyses for total coliform and E. coli in accordance with the 

analytical methods approved in §§ 141.21(f)(3) and 141.21(f)(6) ) until March 31, 2016[DATE 

THREE YEARS AFTER PUBLICATION OF THE FINAL RULE], and in accordance with 

the analytical methods approved in § 141.852 beginning April 1, 2016[DATE THREE YEARS 

AFTER PUBLICATION OF THE FINAL RULE].

*****
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(5) The invalidation of a total coliform sample result can be made only by the Administrator in 

accordance with §§ 141.21(c)(1)(i), (ii), or (iii) or by the certified laboratory in accordance with 

§ 141.21(c)(2) until March 31, 2016[DATE THREE YEARS AFTER PUBLICATION OF 

THE FINAL RULE], or in accordance with § 141.853(c) beginning April 1, 2016[DATE 

THREE YEARS AFTER PUBLICATION OF THE FINAL RULE], with the Administrator 

acting as the State.

*****

20. Part 141 is amended by adding a new subpart Y to read as follows:

Subpart Y - Revised Total Coliform Rule 

Sec.

141.851 General.

141.852 Analytical methods and laboratory certification.

141.853 General monitoring requirements for all public water systems.

141.854 Routine monitoring requirements for non-community water systems serving 1,000 or 

fewer people using only ground water.

141.855 Routine monitoring requirements for community water systems serving 1,000 or fewer 

people using only ground water.

141.856 Routine monitoring requirements for subpart H public water systems of this part 

serving 1,000 or fewer people.
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141.857 Routine monitoring requirements for public water systems serving more than 1,000 

people.

141.858 Repeat monitoring and E. coli requirements.

141.859 Coliform treatment technique triggers and assessment requirements for protection 

against potential fecal contamination.

141.860 Violations.

141.861 Reporting and recordkeeping.

Subpart Y - Revised Total Coliform Rule 

§ 141.851 General.

(a) General. The provisions of this subpart include both maximum contaminant level and 

treatment technique requirements.

(b) Applicability. The provisions of this subpart apply to all public water systems.

(c) Compliance date. Systems must comply with the provisions of this subpart beginning April 

1, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE], unless 

otherwise specified in this subpart.

(d) Implementation with EPA as State. Systems falling under direct oversight of EPA, where 

EPA acts as the State, must comply with decisions made by EPA for implementation of subpart 

Y. EPA has authority to establish such procedures and criteria as are necessary to implement 

subpart Y. 

(e) Violations of national primary drinking water regulations. Failure to comply with the 

applicable requirements of §§ 141.851 through 141.861, including requirements established by 
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the State pursuant to these provisions, is a violation of the national primary drinking water 

regulations under subpart Y.

§ 141.852 Analytical methods and laboratory certification.

 (a) Analytical methodology. (1) The standard sample volume required for analysis, regardless of 

analytical method used, is 100 ml.

(2) Systems need only determine the presence or absence of total coliforms and E. coli; a 

determination of density is not required.

(3) The time from sample collection to initiation of test medium incubation may not exceed 30 

hours. Systems are encouraged but not required to hold samples below 10 deg. C during transit.

(4) If water having residual chlorine (measured as free, combined, or total chlorine) is to be 

analyzed, sufficient sodium thiosulfate (Na2S2O3) must be added to the sample bottle before 

sterilization to neutralize any residual chlorine in the water sample. Dechlorination procedures 

are addressed in Section 9060A.2 of Standard Methods for the Examination of Water and 

Wastewater (20th and 21st editions).

(5) Systems must conduct total coliform and E. coli analyses in accordance with one of the 

analytical methods in the following table or one of the alternative methods listed in Appendix A 

to subpart C of part 141.

Organism Methodology 

Category

Method 1 Citation 1

Total Coliforms

Lactose 

Fermentation 

Methods

Standard Total Coliform 

Fermentation Technique 

Standard Methods 9221 

B.1, B.2 (20th ed.; 21st

ed.) 2, 3

Comment [JRJ226]: Formatting 

changes due to Incorporation by 

Reference of the methods, approved 

by the Office of the Federal Register. 

There are no changes in the 

requirements
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Standard Methods Online

9221 B.1, B.2-99 2, 3

Presence-Absence (P-A) 

Coliform Test 

Standard Methods 9221 

D.1, D.2 (20th ed.; 21st

ed.) 2, 7

Standard Methods Online

9221 D.1, D.2-99 2, 7

Membrane 

Filtration

Methods

Standard Total Coliform 

Membrane Filter 

Procedure 

Standard Methods 9222

B, C (20th ed.; 21st ed.) 2, 

4

Standard Methods 

Online 9222 B-97 2, 4, 

9222 C-97 2, 4

Membrane Filtration using 

MI medium

EPA Method 1604 2

m-ColiBlue24® Test 2, 4

Chromocult 2, 4

Enzyme Substrate 

Methods

Colilert® Standard Methods 9223 

B (20th ed.; 21st ed.) 2, 5

Standard Methods Online

9223 B-97 2, 5

Colisure® Standard Methods 9223 

B (20th ed.; 21st ed.) 2, 5, 6

Standard Methods Online

9223 B-97 2, 5, 6

E*Colite® Test 2

Readycult® Test 2

modified Colitag® Test 2

Escherichia coli

Escherichia coli

Procedure 

(following 

Lactose 

Fermentation 

Methods)

EC-MUG medium Standard Methods 9221 

F.1 (20th ed.; 21st ed.) 2

Escherichia coli 

Partition Method

EC broth with MUG (ECMUG)Standard Methods 9222 

G.1c(2) (20th ed.; 21st
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ed.) 2, 8

NA-MUG medium Standard Methods 9222 

G.1c(1) (20th ed.; 21st

ed.) 2

Membrane 

Filtration 

Methods

Membrane Filtration using 

MI medium

EPA Method 1604 2

m-ColiBlue24® Test 2, 4

Chromocult 2, 4

Enzyme Substrate

Methods

Colilert® Standard Methods 9223 

B (20th ed.; 21st ed.) 2, 5

Standard Methods Online

9223 B-97 2, 5, 6

Colisure® Standard Methods 9223 

B (20th ed.; 21st ed.) 2, 5, 6

Standard Methods Online

9223 B-97 2, 5, 6

E*Colite® Test 2

Readycult® Test 2

modified Colitag® Test 2

1 The procedures must be done in accordance with the documents listed in paragraph (c) of this 

section. For Standard Methods, either editions, 20th (1998) or 21st (2005), may be used. For the 

Standard Methods Online, the year in which each method was approved by the Standard Methods 

Committee is designated by the last two digits following the hyphen in the method number. The 

methods listed are the only online versions that may be used. For vendor methods, the date of the 

method listed in paragraph (c) of this section is the date/version of the approved method. The 

methods listed are the only versions that may be used for compliance with this rule. Laboratories 

should be careful to use only the approved versions of the methods, as product package inserts may 

not be the same as the approved versions of the methods.

2 Incorporated by reference. See paragraph (c) of this section. 

3 Lactose broth, as commercially available, may be used in lieu of lauryl tryptose broth, if the system 

conducts at least 25 parallel tests between lactose broth and lauryl tryptose broth using the water 

normally tested, and if the findings from this comparison demonstrate that the false-positive rate and 

false-negative rate for total coliforms, using lactose broth, is less than 10 percent.

4 All filtration series must begin with membrane filtration equipment that has been sterilized by 

autoclaving. Exposure of filtration equipment to UV light is not adequate to ensure sterilization. 

Subsequent to the initial autoclaving, exposure of the filtration equipment to UV light may be used to 

sanitize the funnels between filtrations within a filtration series. Alternatively, membrane filtration 

equipment that is pre-sterilized by the manufacturer (i.e., disposable funnel units) may be used.

5 Multiple-tube and multi-well enumerative formats for this method are approved for use in presenceabsence determination under this regulation. 
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6 Colisure® results may be read after an incubation time of 24 hours.

7 A multiple tube enumerative format, as described in Standard Methods for the Examination of Water 

and Wastewater 9221, is approved for this method for use in presence-absence determination under 

this regulation. 

8 The following changes must be made to the EC broth with MUG (EC-MUG) formulation: 

Potassium dihydrogen phosphate, KH2PO4, must be 1.5g, and 4-methylumbelliferyl-Beta-Dglucuronide must be 0.05 g.

 (b) Laboratory certification. Systems must have all compliance samples required under this 

subpart analyzed by a laboratory certified by the EPA or a primacy State to analyze drinking 

water samples. The laboratory used by the system must be certified for each method (and 

associated contaminant(s)) used for compliance monitoring analyses under this rule.

 (c) Incorporation by reference. The standards required in this section are incorporated by 

reference into this section with the approval of the Director of the Federal Register under 5 

U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, 

EPA must publish notice of change in the Federal Register and the material must be available to 

the public. All approved material is available for inspection either electronically at 

www.regulations.gov, in hard copy at the Water Docket, or from the sources indicated below. 

The Docket ID is EPA-HQ-OW-2008-0878. Hard copies of these documents may be viewed at 

the Water Docket in the EPA Docket Center, (EPA/DC) EPA West, Room 3334, 1301 

Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is 

open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 

telephone number for the Public Reading Room is 1-202-566-1744, and the telephone number 

for the Water Docket is 1-202-566-2426. Copyrighted materials are only available for viewing 

in hard copy. These documents are also available for inspection at the National Archives and 

Records Administration (NARA). For information on the availability of this material at NARA, 
*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 283 of 325

call 1-202-741-6030 or go to: 

http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_ locations.html.

(1) American Public Health Association, 800 I Street, NW, Washington, DC 20001

(i) “Standard Methods for the Examination of Water and Wastewater,” 20th edition (1998):

(A) Standard Methods 9221, “Multiple-Tube Fermentation Technique for Members of the 

Coliform Group,” B.1, B.2, “Standard Total Coliform Fermentation Technique.”

(B) Standard Methods 9221, “Multiple-Tube Fermentation Technique for Members of the 

Coliform Group,” D.1, D.2, “Presence-Absence (P-A) Coliform Test.”

(C) Standard Methods 9222, “Membrane Filter Technique for Members of the Coliform Group,” 

B, “Standard Total Coliform Membrane Filter Procedure.”

(D) Standard Methods 9222, “Membrane Filter Technique for Members of the Coliform Group,” 

C, “Delayed-Incubation Total Coliform Procedure.”

(E) Standard Methods 9223, “Enzyme Substrate Coliform Test,” B, “Enzyme Substrate Test,” 

Colilert® and Colisure®.

(F) Standard Methods 9221, “Multiple Tube Fermentation Technique for Members of the 

Coliform Group,” F.1, “Escherichia coli Procedure: EC-MUG medium.”

(G) Standard Methods 9222, “Membrane Filter Technique for Members of the Coliform Group,” 

G.1.c(2), “Escherichia coli Partition Method: EC broth with MUG (EC-MUG).”

(H) Standard Methods 9222, “Membrane Filter Technique for Members of the Coliform Group,” 

G.1.c(1), “Escherichia coli Partition Method: NA-MUG medium.”

(ii) “Standard Methods for the Examination of Water and Wastewater,” 21st edition (2005):

(A) Standard Methods 9221, “Multiple-Tube Fermentation Technique for Members of the 

Coliform Group,” B.1, B.2, “Standard Total Coliform Fermentation Technique.”
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(B) Standard Methods 9221, “Multiple-Tube Fermentation Technique for Members of the 

Coliform Group,” D.1, D.2, “Presence-Absence (P-A) Coliform Test.”

(C) Standard Methods 9222, “Membrane Filter Technique for Members of the Coliform Group,” 

B, “Standard Total Coliform Membrane Filter Procedure.”

(D) Standard Methods 9222, “Membrane Filter Technique for Members of the Coliform Group,” 

C, “Delayed-Incubation Total Coliform Procedure.”

(E) Standard Methods 9223, “Enzyme Substrate Coliform Test,” B, “Enzyme Substrate Test,” 

Colilert® and Colisure®.

(F) Standard Methods 9221, “Multiple Tube Fermentation Technique for Members of the 

Coliform Group,” F.1, “Escherichia coli Procedure: EC-MUG medium.”

(G) Standard Methods 9222, “Membrane Filter Technique for Members of the Coliform Group,” 

G.1.c(2), “Escherichia coli Partition Method: EC broth with MUG (EC-MUG).”

(H) Standard Methods 9222, “Membrane Filter Technique for Members of the Coliform Group,” 

G.1.c(1), “Escherichia coli Partition Method: NA-MUG medium.”

(iii) “Standard Methods Online” available at http://www.standardmethods.org: 

(A) Standard Methods Online 9221, “Multiple-Tube Fermentation Technique for Members of the 

Coliform Group” (1999), B.1, B.2-99, “Standard Total Coliform Fermentation Technique.”

(B) Standard Methods Online 9221, “Multiple-Tube Fermentation Technique for Members of the 

Coliform Group” (1999), D.1, D.2-99, “Presence-Absence (P-A) Coliform Test.”

(C) Standard Methods Online 9222, “Membrane Filter Technique for Members of the Coliform 

Group” (1997), B-97, “Standard Total Coliform Membrane Filter Procedure.”

(D) Standard Methods Online 9222, “Membrane Filter Technique for Members of the Coliform 

Group” (1997), C-97, “Delayed-Incubation Total Coliform Procedure.”
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(E) Standard Methods Online 9223, “Enzyme Substrate Coliform Test” (1997), B-97, “Enzyme 

Substrate Test”, Colilert® and Colisure®.

(2) Charm Sciences, Inc., 659 Andover Street, Lawrence, MA 01843-1032, telephone 1-800-

343-2170: 

(i) E*Colite® – “Charm E*ColiteTM Presence/Absence Test for Detection and Identification of 

Coliform Bacteria and Escherichia coli in Drinking Water,” January 9, 1998.

(ii) [Reserved]

(3) CPI International, Inc., 5580 Skylane Blvd., Santa Rosa, CA, 95403, telephone 1-800-878-

7654:

(i) modified Colitag®, ATP D05-0035 – “Modified ColitagTM Test Method for the Simultaneous 

Detection of E. coli and other Total Coliforms in Water,” August 28, 2009.

(ii) [Reserved]

(4) EMD Millipore (a division of Merck KGaA, Darmstadt Germany), 290 Concord Road, 

Billerica, MA 01821, telephone 1-800-645-5476:

(i) Chromocult – “Chromocult® Coliform Agar Presence/Absence Membrane Filter Test Method 

for Detection and Identification of Coliform Bacteria and Escherichia coli for Finished Waters,” 

November 2000, Version 1.0.

(ii) Readycult® – “Readycult® Coliforms 100 Presence/Absence Test for Detection and 

Identification of Coliform Bacteria and Escherichia coli in Finished Waters,” January 2007,

Version 1.1.

(5) EPA’s Water Resource Center (MC-4100T), 1200 Pennsylvania Avenue, NW, Washington, 

DC 20460, telephone 1-202-566-1729:
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(i) EPA Method 1604, EPA 821-R-02-024 – “EPA Method 1604: Total Coliforms and 

Escherichia coli in Water by Membrane Filtration Using a Simultaneous Detection Technique 

(MI Medium),” September 2002, http://www.epa.gov/nerlcwww/1604sp02.pdf.

(ii) [Reserved]

(6) Hach Company, P.O. Box 389, Loveland, CO 80539, telephone 1-800-604-3493:

(i) m-ColiBlue24® – “Membrane Filtration Method m-ColiBlue24® Broth,” Revision 2, August 

17, 1999.

(ii) [Reserved] (a) Analytical methodology. (1) The standard sample volume required for

analysis, regardless of analytical method used, is 100 ml.

(2) Systems need only determine the presence or absence of total coliforms and E. coli; a 

determination of density is not required.

(3) The time from sample collection to initiation of test medium incubation may not exceed 30 

hours. Systems are encouraged but not required to hold samples below 10 deg. C during transit.

(4) If water having residual chlorine (measured as free, combined, or total chlorine) is to be 

analyzed, sufficient sodium thiosulfate (Na2S2O3) must be added to the sample bottle before 

sterilization to neutralize any residual chlorine in the water sample. Dechlorination procedures 

are addressed in Section 9060A.2 of Standard Methods for the Examination of Water and 

Wastewater (20th and 21st editions).

(5) Systems must conduct total coliform and E. coli analyses in accordance with one of the 

analytical methods in the following table or one of the alternative methods listed in Appendix A 

to subpart C of part 141.

Organism Methodology 

Category

Method Citation

Total Coliforms
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Lactose 

Fermentation 

Methods

Standard Total Coliform 

Fermentation Technique 

Standard Methods 

9221 B.1, B.2 1, 2

Standard Methods 

online

9221 B.1, B.2-991, 2

Presence-Absence (P-A) 

Coliform Test 

Standard Methods 

9221 D.1, D.2 1, 12

Standard Methods 

online

9221 D.1, D.2-991, 12

Membrane 

Filtration

Methods

Standard Total Coliform 

Membrane Filter Procedure 

Standard Methods 

9222 B, C 1, 3

Standard Methods 

online 9222 B-971, 3, 

9222 C-971, 3

Membrane Filtration using MI 

medium

EPA Method 1604 3, 4

m-ColiBlue24® Test 3, 5

Chromocult 3, 6

Enzyme Substrate 

Methods

Colilert® Standard Methods 

9223 B 1, 7

Standard Methods 

online

9223 B-971, 7

Colisure® Standard Methods 

9223 B 1, 7, 8

Standard Methods 

online

9223 B-971, 7, 8

E*Colite® Test 9

Readycult® Test 10

modified Colitag® Test 11

Escherichia coli

Escherichia coli

Procedure 

(following 

Lactose 

EC-MUG medium Standard Methods 

9221 F.1 1
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Fermentation 

Methods)

Escherichia coli 

Partition Method

EC broth with MUG (ECMUG)Standard Methods 

9222 G.1c(2)1, 13

NA-MUG medium Standard Methods 

9222 G.1c(1)1

Membrane 

Filtration 

Methods

Membrane Filtration using MI 

medium

EPA Method 1604 3, 4

m-ColiBlue24® Test 3, 5

Chromocult 3, 6

Enzyme Substrate 

Methods

Colilert® Standard Methods 

9223 B 1, 7

Standard Methods 

online

9223 B-971, 7, 8

Colisure® Standard Methods 

9223 B 1, 7, 8

Standard Methods 

online

9223 B-971, 7, 8

E*Colite® Test 9

Readycult® Test 10

modified Colitag® Test 11

The procedures must be done in accordance with the documents listed below. For vendor methods, 

the date of the method listed here is the date/version of the approved method. The methods listed are 

the only versions that may be used for compliance with this rule. Laboratories should be careful to 

use only the approved versions of the methods, as product package inserts may not be the same as the 

approved versions of the methods.

The Director of the Federal Register approved the incorporation by reference of the documents listed 

in footnotes 1, 4, 5, 6, 9, 10, and 11 in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. 

Publicly available docket materials are available either electronically in www.regulations.gov or in 

hard copy at the Water Docket. The Docket ID is EPA –HQ-OW-2008-0878. Hard copies of these 

documents may be viewed at the Water Docket in the EPA Docket Center, (EPA/DC) EPA West, 

Room 3334, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading 

Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 

telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the 

Water Docket is (202) 566-2426. Copyrighted materials are only available for viewing in hard copy. 

These documents may also be viewed at the National Archives and Records Administration (NARA). 

For information on the availability of this material at NARA, call 1-866-272-6272 or go to: 

http://www.archives.gov/locations/.
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1 Methods are described in Standard Methods for the Examination of Water and Wastewater, 20th

edition (1998), or 21st edition (2005). American Public Health Association, 800 I Street, NW, 

Washington, DC 20001. The cited methods published in either of these two editions may be used. . 

Standard Methods Online is available at http://www.standardmethods.org. The year in which each 

method was approved by the Standard Methods Committee is designated by the last two digits 

following the hyphen in the method number. The methods listed are the only online versions that may 

be used.

2

Lactose broth, as commercially available, may be used in lieu of lauryl tryptose broth, if the system 

conducts at least 25 parallel tests between lactose broth and lauryl tryptose broth using the water 

normally tested, and if the findings from this comparison demonstrate that the false-positive rate and 

false-negative rate for total coliforms, using lactose broth, is less than 10 percent.

3 All filtration series must begin with membrane filtration equipment that has been sterilized by 

autoclaving. Exposure of filtration equipment to UV light is not adequate to ensure sterilization. 

Subsequent to the initial autoclaving, exposure of the filtration equipment to UV light may be used to 

sanitize the funnels between filtrations within a filtration series. Alternatively, membrane filtration 

equipment that is pre-sterilized by the manufacturer (i.e., disposable funnel units) may be used.

4

EPA Method 1604: Total Coliforms and Escherichia coli in Water by Membrane Filtration Using a 

Simultaneous Detection Technique (MI Medium); September 2002, EPA 821-R-02-024. The method 

is available at http://www.epa.gov/nerlcwww/1604sp02.pdf or from EPA’s Water Resource Center 

(RC-4100T), 1200 Pennsylvania Avenue, NW, Washington, DC 20460.

5

The m-ColiBlue24® test is described in the document “Membrane Filtration Method m-ColiBlue24® 

Broth, Revision 2, August 17, 1999”, available from the Hach Company, P.O. Box 389, Loveland, CO 

80539.

6

The Chromocult test is described in the document “Chromocult® Coliform Agar Presence/Absence 

Membrane Filter Test Method for Detection and Identification of Coliform Bacteria and Escherichia 

coli in Finished Waters,” November 2000, Version 1.0, available from EMD Chemicals (an affiliate of 

Merck KGaA, Darmstadt Germany), 480 S. Democrat Road, Gibbstown, NJ 08027-1297. (Telephone 

(800) 222-0342).

7 Multiple-tube and multi-well enumerative formats for this method are approved for use in presenceabsence determination under this regulation. 

8

Colisure® results may be read after an incubation time of 24 hours.

9

The E*Colite® test is described in the document “Charm E*ColiteTM Presence/Absence Test for 

Detection and Identification of Coliform Bacteria and Escherichia coli in Drinking Water”, January 9, 

1998, available from Charm Sciences, Inc., 659 Andover Street, Lawrence, MA 01843-1032.

10The Readycult® test is described in the document “Readycult® Coliforms 100 Presence/Absence 

Test for Detection and Identification of Coliform Bacteria and Escherichia coli in Finished Waters, 

January 2007, Version 1.1,” available from EMD Chemicals (an affiliate of Merck KGaA, Darmstadt 

Germany), 480 S. Democrat Road, Gibbstown, NJ 08027-1297. (Telephone (800) 222-0342). Internet 

address http://www.readycult.com.

11The Colitag® test is described in the document “Modified ColitagTM Test Method for the 

Simultaneous Detection of E. coli and other Total Coliforms in Water,” August 28, 2009, available 
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from CPI International, Inc., 5580 Skylane Blvd., Santa Rosa, CA, 95403. (Telephone (800) 878-

7654, Fax (707) 545-7901). Internet address http://www.cpiinternational.com.

12A multiple tube enumerative format, as described in Standard Methods for the Examination of Water 

and Wastewater 9221, is approved for this method for use in presence-absence determination under 

this regulation. 

13The following changes must be made to the EC broth with MUG (EC-MUG) formulation: 

Potassium dihydrogen phosphate, KH2PO4, must be 1.5g, and 4-methylumbelliferyl-Beta-Dglucuronide must be 0.05 g.

(b) Laboratory certification. Systems must have all compliance samples required under this 

subpart analyzed by a laboratory certified by the EPA or a primacy State to analyze drinking 

water samples. The laboratory used by the system must be certified for each method (and 

associated contaminant(s)) used for compliance monitoring analyses under this rule.

§ 141.853 General monitoring requirements for all public water systems.

(a) Sample siting plans. (1) Systems must develop a written sample siting plan that identifies 

sampling sites and a sample collection schedule that are representative of water throughout the 

distribution system not later than March 31, 2016[DATE THREE YEARS AFTER 

PUBLICATION OF FINAL RULE]. These plans are subject to State review and revision. 

Systems must collect total coliform samples according to the written sample siting plan. 

Monitoring required by §§ 141.854 through 141.858 may take place at a customer’s premise, 

dedicated sampling station, or other designated compliance sampling location. Routine and 

repeat sample sites and any sampling points necessary to meet the requirements of subpart S 

must be reflected in the sampling plan. 

(2) Systems must collect samples at regular time intervals throughout the month, except that 

systems that use only ground water and serve 4,900 or fewer people may collect all required 

samples on a single day if they are taken from different sites.
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(3) Systems must take at least the minimum number of required samples even if the system has 

had an E. coli MCL violation or has exceeded the coliform treatment technique triggers in § 

141.859(a).

(4) A system may conduct more compliance monitoring than is required by this subpart to 

investigate potential problems in the distribution system and use monitoring as a tool to assist in 

uncovering problems. A system may take more than the minimum number of required routine 

samples and must include the results in calculating whether the coliform treatment technique 

trigger in §141.859(a)(1)(i) and (ii) has been exceeded only if the samples are taken in 

accordance with the existing sample siting plan and are representative of water throughout the 

distribution system.

(5) Systems must identify repeat monitoring locations in the sample siting plan. Unless the 

provisions of paragraphs (a)(5)(i) or (a)(5)(ii) of this section are met, the system must collect at 

least one repeat sample from the sampling tap where the original total coliform-positive sample 

was taken, and at least one repeat sample at a tap within five service connections upstream and at 

least one repeat sample at a tap within five service connections downstream of the original 

sampling site. If a total coliform-positive sample is at the end of the distribution system, or one 

service connection away from the end of the distribution system, the system must still take all 

required repeat samples. However, the State may allow an alternative sampling location in lieu 

of the requirement to collect at least one repeat sample upstream or downstream of the original 

sampling site. Except as provided for in paragraph (a)(5)(ii) of this section, systems required to 

conduct triggered source water monitoring under § 141.402(a) must take ground water source 

sample(s) in addition to repeat samples required under this subpart.

(i) Systems may propose repeat monitoring locations to the State that the system believes to be 
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representative of a pathway for contamination of the distribution system. A system may elect to 

specify either alternative fixed locations or criteria for selecting repeat sampling sites on a 

situational basis in a standard operating procedure (SOP) in its sample siting plan. The system 

must design its SOP to focus the repeat samples at locations that best verify and determine the 

extent of potential contamination of the distribution system area based on specific situations. 

The State may modify the SOP or require alternative monitoring locations as needed.

(ii) Ground water systems serving 1,000 or fewer people may propose repeat sampling locations 

to the State that differentiate potential source water and distribution system contamination (e.g.,

by sampling at entry points to the distribution system). A ground water system with a single well 

required to conduct triggered source water monitoring may, with written State approval, take one 

of its repeat samples at the monitoring location required for triggered source water monitoring 

under § 141.402(a) if the system demonstrates to the State’s satisfaction that the sample siting 

plan remains representative of water quality in the distribution system. If approved by the State, 

the system may use that sample result to meet the monitoring requirements in both § 141.402(a) 

and this section.

(A) If a repeat sample taken at the monitoring location required for triggered source water 

monitoring is E. coli-positive, the system has violated the E. coli MCL and must also comply 

with § 141.402(a)(3). If a system takes more than one repeat sample at the monitoring location 

required for triggered source water monitoring, the system may reduce the number of additional 

source water samples required under § 141.402(a)(3) by the number of repeat samples taken at 

that location that were not E. coli-positive.

(B) If a system takes more than one repeat sample at the monitoring location required for 

triggered source water monitoring under § 141.402(a), and more than one repeat sample is E. 
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coli-positive, the system has violated the E. coli MCL and must also comply with § 

141.403(a)(1).

(C) If all repeat samples taken at the monitoring location required for triggered source water 

monitoring are E. coli-negative and a repeat sample taken at a monitoring location other than the 

one required for triggered source water monitoring is E. coli-positive, the system has violated the 

E. coli MCL, but is not required to comply with § 141.402(a)(3).

(6) States may review, revise, and approve, as necessary appropriate, repeat sampling proposed 

by systems under paragraphs (a)(5)(i) and (ii) of this section. The system must demonstrate to 

the State’s satisfaction that the sample siting plan remains representative of the water quality in 

the distribution system. The State may determine that monitoring at the entry point to the 

distribution system (especially for undisinfected ground water systems) is effective to 

differentiate between potential source water and distribution system problems. 

 (b) Special purpose samples. Special purpose samples, such as those taken to determine 

whether disinfection practices are sufficient following pipe placement, replacement, or repair, 

must not be used to determine whether the coliform treatment technique trigger has been 

exceeded. Repeat samples taken pursuant to § 141.858 are not considered special purpose 

samples, and must be used to determine whether the coliform treatment technique trigger has 

been exceeded.

 (c) Invalidation of total coliform samples. A total coliform-positive sample invalidated under 

this paragraph (c) of this section does not count toward meeting the minimum monitoring 

requirements of this subpart.

 (1) The State may invalidate a total coliform-positive sample only if the conditions of 

paragraph (c)(1)(i), (ii), or (iii) of this section are met.

Comment [EPA227]: In some cases 

it is necessary. Sampling plans must 

be representative of the distribution 

system. In those instances where a 

non-default approach is allowed,

states have the ability to review and 

modify the system’s proposal. Para 

(a)(5)(i) will be used in the 

overwhelming number of cases by 

larger systems taking many samples 

per month and having greater 

technical capability. We believe that 

it is appropriate that this be selfimplementing once the system notifies 

the state, without prior state approval. 

Para (a)(5)(ii) can only be used by 

systems serving 1,000 or less, who 

take 1 routine sample/monitoring 

period and generally lack the technical 

sophistication to make informed 

decisions. While it will be generally 

appropriate to allow dual purpose 

samples for PWSs consisting of little 

or no buried distribution system, it 

would be generally wildly 

inappropriate to allow a dual purpose 

sample in a PWS with more extensive 

buried distribution system, especially 

if the single routine monitoring 

location is not near the entrance to the 

distribution system. Prior written 

state approval is therefore necessary 

(not appropriate) before a system may 

take a dual purpose sample.

JL: How about suggested edit. My 

concern is that this phrase implies 

state approval is necessary. Even 

without it, the language is clear that 

states have discretion to require 

something different if they disagree.

EPA - ok

Comment [JL228]: This suggests 

that state approval is required. I 

thought this was not your intent.
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 (i) The laboratory establishes that improper sample analysis caused the total coliform-positive 

result.

 (ii) The State, on the basis of the results of repeat samples collected as required under § 

141.858(a), determines that the total coliform-positive sample resulted from a domestic or other 

non-distribution system plumbing problem. The State cannot invalidate a sample on the basis of 

repeat sample results unless all repeat sample(s) collected at the same tap as the original total 

coliform-positive sample are also total coliform-positive, and all repeat samples collected at a 

location other than the original tap are total coliform-negative (e.g., a State cannot invalidate a 

total coliform-positive sample on the basis of repeat samples if all the repeat samples are total 

coliform-negative, or if the system has only one service connection).

 (iii) The State has substantial grounds to believe that a total coliform-positive result is due to a 

circumstance or condition that does not reflect water quality in the distribution system. In this 

case, the system must still collect all repeat samples required under § 141.858(a), and use them 

to determine whether a coliform treatment technique trigger in § 141.859 has been exceeded. To 

invalidate a total coliform-positive sample under this paragraph, the decision and supporting 

rationale must be documented in writing, and approved and signed by the supervisor of the State 

official who recommended the decision. The State must make this document available to EPA 

and the public. The written documentation must state the specific cause of the total coliformpositive sample, and what action the system has taken, or will take, to correct this problem. The 

State may not invalidate a total coliform-positive sample solely on the grounds that all repeat 

samples are total coliform-negative.

 (2) A laboratory must invalidate a total coliform sample (unless total coliforms are detected) if 

the sample produces a turbid culture in the absence of gas production using an analytical method 

Comment [JL229]: Why is this 

necessary?

Comment [EPA230]: This is a 

carryover from an existing TCR 

provision (141.21(c)(1)(ii)). The 

rationale is that this is necessary, but 

not sufficient, to determine that the 

problem is due to a domestic/non-DS 

plumbing problem and that the sample 

may be invalidated.

Comment [JL231]: Is this necessary?

Comment [EPA232]: A carryover 

from the TCR (141.21(c)(1)(iii)). 

Since this was not discussed by the 

advisory committee, we carried it 

forward from the TCR, as 

recommended in the AIP for such 

non-addressed provisions. It was 

included in the TCR because such an 

important discretionary decision 

should not be left to a single (possibly 

very junior) individual.
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where gas formation is examined (e.g., the Multiple-Tube Fermentation Technique), produces a 

turbid culture in the absence of an acid reaction in the Presence-Absence (P-A) Coliform Test, or 

exhibits confluent growth or produces colonies too numerous to count with an analytical method 

using a membrane filter (e.g., Membrane Filter Technique). If a laboratory invalidates a sample 

because of such interference, the system must collect another sample from the same location as 

the original sample within 24 hours of being notified of the interference problem, and have it 

analyzed for the presence of total coliforms. The system must continue to re-sample within 24 

hours and have the samples analyzed until it obtains a valid result. The State may waive the 24-

hour time limit on a case-by-case basis. Alternatively, the State may implement criteria for 

waiving the 24-hour sampling time limit to use in lieu of case-by-case extensions.

§ 141.854 Routine monitoring requirements for non-community water systems serving 

1,000 or fewer people using only ground water.

(a) General. (1) The provisions of this section apply to non-community water systems using 

only ground water (except ground water under the direct influence of surface water, as defined in 

§ 141.2) and serving 1,000 or fewer people.

(2) Following any total coliform-positive sample taken under the provisions of this section, 

systems must comply with the repeat monitoring requirements and E. coli analytical 

requirements in § 141.858.

(3) Once all monitoring required by this section and § 141.858 for a calendar month has been 

completed, systems must determine whether any coliform treatment technique triggers specified 

in § 141.859 have been exceeded. If any trigger has been exceeded, systems must complete 

assessments as required by § 141.859.
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(4) For the purpose of determining eligibility for remaining on or qualifying for quarterly 

monitoring under the provisions of paragraphs (f)(4) and (g)(2), respectively, of this section for 

transient non-community water systems, the State may elect to not count monitoring violations 

under § 141.860(c)(1) of this part if the missed sample is collected no later than the end of the 

monitoring period following the monitoring period in which the sample was missed. The system 

must collect the make-up sample in a different week than the routine sample for that monitoring 

period and should collect the sample as soon as possible during the monitoring period. The State 

may not use this provision under paragraph (h) of this section. This authority does not affect the 

provisions of §§ 141.860(c)(1) and 141.861(a)(4) of this part.

(b) Monitoring frequency for total coliforms. Systems must monitor each calendar quarter that 

the system provides water to the public, except for seasonal systems or as provided under 

paragraphs (c) though (h) and (j) of this section. Seasonal systems must meet the monitoring 

requirements of paragraph (i) of this section.

(c) Transition to subpart Y. (1) Systems, including seasonal systems, must continue to monitor 

according to the total coliform monitoring schedules under § 141.21 that were in effect on March 

31, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE] unless 

any of the conditions for increased monitoring in paragraph (f) of this section are triggered on or 

after April 1, 2016[DATE THREE YEARS AFTER PUBLICATION OF THE FINAL 

RULE] or unless otherwise directed by the State.

(2) After [DATE THREE YEARS AFTER PUBLICATION OF THE FINAL 

RULE]Beginning April 1, 2016, the State must perform a special monitoring evaluation during 

each sanitary survey to review the status of the system, including the distribution system, to 

determine whether the system is on an appropriate monitoring schedule. After the State has 
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performed the special monitoring evaluation during each sanitary survey, the State may modify 

the system’s monitoring schedule, as necessary, or it may allow the system to stay on its existing 

monitoring schedule, consistent with the provisions of this section. The State may not allow 

systems to begin less frequent reduce monitoring under the special monitoring evaluation unless 

the system has already met the applicable criteria for reduced less frequent monitoring in this 

section. For seasonal systems on quarterly or annual monitoring, this evaluation must include 

review of the approved sample siting plan, which must designate the time period(s) for 

monitoring based on site-specific considerations (e.g., during periods of highest demand or 

highest vulnerability to contamination). The seasonal system must collect compliance samples 

during these time periods.

(d) Annual site visits. Beginning no later than [DATE FOUR YEARS AFTER 

PUBLICATION OF THE FINAL RULE]calendar year 2017, systems on annual monitoring, 

including seasonal systems, must have an initial and recurring annual site visit by the State that is 

equivalent to a Level 2 assessment or an annual voluntary Level 2 assessment that meets the 

criteria in §141.859(b) to remain on annual monitoring. The periodic required sanitary survey 

may be used to meet the requirement for an annual site visit for the year in which the sanitary 

survey was completed.

(e) Criteria for annual monitoring. Beginning April 1, 2016[DATE THREE YEARS AFTER 

PUBLICATION OF THE FINAL RULE], the State may reduce the monitoring frequency for 

a well-operated ground water system from quarterly routine monitoring to no less than annual 

monitoring, if the system demonstrates that it meets the criteria for reduced monitoring in 

paragraphs (e)(1) through (e)(3) of this section, except for a system that has been on increased 

monitoring under the provisions of paragraph (f) of this section. A system on increased 

Comment [EPA233]: Ok with this 

OMB clarification.

Comment [JL234]: Can they keep 

the system on an already reduced 

monitoring schedule. Clarify.

Comment [EPA235]: Edited for 

clarification – parallel edit made to 

141.855(c)(2). Systems on existing 

increased/routine/reduced monitoring 

stay on that schedule unless 1) they 

otherwise meet the criteria for less 

frequent monitoring or 2) the state, 

after the special monitoring 

evaluation, determines that the 

monitoring frequency in EPA’s rule is 

not sufficient to adequately 

characterize the water in the DS. In 

1), the state may want to actually see 

the system and its records prior to 

reducing monitoring, instead of 

relying solely on the necessary (but 

not always sufficient) objective 

standards in the RTCR. In 2), the 

state may determine (as an example) 

that a system should increase 

monitoring frequency from a single 

monthly sample taken in a rural CWS 

with 500 people and dozens of miles 

of pipe because a single sample is not 

adequate. Since 2) is more stringent, 

it does not need to be specified in the 

rule.
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monitoring under paragraph (f) of this section must meet the provisions of paragraph (g) of this 

section to go to quarterly monitoring and must meet the provisions of paragraph (h) of this 

section to go to annual monitoring. 

(1) The system has a clean compliance history for a minimum of 12 months; 

(2) The most recent sanitary survey shows that the system is free of sanitary defects or has 

corrected all identified sanitary defects, has a protected water source, and meets approved 

construction standards; and

(3) The State has conducted an annual site visit within the last 12 months and the system has 

corrected all identified sanitary defects. The system may substitute a Level 2 assessment that 

meets the criteria in §141.859(b) for the State annual site visit.

(f) Increased Monitoring Requirements for systems on quarterly or annual monitoring. A 

system on quarterly or annual monitoring that experiences any of the events identified in 

paragraphs (f)(1) through (f)(4) of this section must begin monthly monitoring the month 

following the event. A system on annual monitoring that experiences the event identified in 

paragraphs (f)(5) of this section must begin quarterly monitoring the quarter following the event. 

The system must continue monthly or quarterly monitoring until the requirements in paragraph 

(g) of this section for quarterly monitoring or paragraph (h) of this section for annual monitoring 

are met. A system on monthly monitoring for reasons other than those identified in paragraphs 

(f)(1) through (f)(4) of this section is not considered to be on increased monitoring for the 

purposes of paragraphs (g) and (h) of this section.

(1) The system triggers a Level 2 assessment or two Level 1 assessments under the provisions 

of §141.859 in a rolling 12-month period.

(2) The system has an E. coli MCL violation.
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(3) The system has a coliform treatment technique violation.

(4) The system has two subpart Y monitoring violations or one subpart Y monitoring violation 

and one Level 1 assessment under the provisions of § 141.859 in a rolling 12-month period for a 

system on quarterly monitoring.

(5) The system has one subpart Y monitoring violation for a system on annual monitoring.

(g) Requirements for returning to quarterly monitoring. The State may reduce the monitoring 

frequency for a system on monthly monitoring triggered under paragraph (f) of this section to 

quarterly monitoring if the system meets the criteria in paragraphs (g)(1) and (g)(2) of this 

section.

(1) Within the last 12 months, the system must have a completed sanitary survey or a site visit 

by the State or a voluntary Level 2 assessment by a party approved by the State, be free of 

sanitary defects, and have a protected water source; and

(2) The system must have a clean compliance history for a minimum of 12 months.

(h) Requirements for systems on increased monitoring to qualify for annual monitoring. The 

State may reduce the monitoring frequency for a system on increased monitoring under 

paragraph (f) of this section if the system meets the criteria in paragraph (g) of this section plus 

the criteria in paragraphs (h)(1) and (h)(2) of this section.

(1) An annual site visit by the State and correction of all identified sanitary defects. The system 

may substitute a voluntary Level 2 assessment by a party approved by the State for the State 

annual site visit in any given year.

(2) The system must have in place or adopt one or more additional enhancements to the water 

system barriers to contamination in paragraphs (h)(2)(i) through (h)(2)(v) of this section.

(i) Cross connection control, as approved by the State.
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(ii) An operator certified by an appropriate State certification program or regular visits by a 

circuit rider certified by an appropriate State certification program.

(iii) Continuous disinfection entering the distribution system and a residual in the distribution 

system in accordance with criteria specified by the State.

(iv) Demonstration of maintenance of at least a 4-log removal or inactivation of viruses as 

provided for under § 141.403(b)(3).

(v) Other equivalent enhancements to water system barriers as approved by the State.

(i) Seasonal systems. (1) Beginning April 1, 2016[DATE THREE YEARS AFTER 

PUBLICATION OF THE FINAL RULE], all seasonal systems must demonstrate completion 

of a State-approved start-up procedure, which may include a requirement for startup sampling 

prior to serving water to the public.

(2) A seasonal system must monitor every month that it is in operation unless it meets the criteria 

in paragraphs (i)(2)(i) through (iii) of this section to be eligible for monitoring less frequently 

than monthly after beginning April 1, 2016[DATE THREE YEARS AFTER PUBLICATION 

OF FINAL RULE], except as provided under paragraph (c) of this section.

(i) Seasonal systems monitoring less frequently than monthly must have an approved sample 

siting plan that designates the time period for monitoring based on site-specific considerations 

(e.g., during periods of highest demand or highest vulnerability to contamination). Seasonal 

systems must collect compliance samples during this time period. 

(ii) To be eligible for quarterly monitoring, the system must meet the criteria in paragraph (g) of 

this section.

(iii) To be eligible for annual monitoring, the system must meet the criteria under paragraph (h)

of this section.
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(3) The State may exempt any seasonal system from some or all of the requirements for seasonal 

systems if the entire distribution system remains pressurized during the entire period that the 

system is not operating, except that systems that monitor less frequently than monthly must still 

monitor during the vulnerable period designated by the State.

(j) Additional routine monitoring the month following a total coliform-positive sample. Systems 

collecting samples on a quarterly or annual frequency must conduct additional routine 

monitoring the month following one or more total coliform-positive samples (with or without a 

Level 1 treatment technique trigger). Systems must collect at least three routine samples during 

the next month, except that the State may waive this requirement if the conditions of paragraph 

(j)(1), (2), or (3) of this section are met. Systems may either collect samples at regular time 

intervals throughout the month or may collect all required routine samples on a single day if 

samples are taken from different sites. Systems must use the results of additional routine 

samples in coliform treatment technique trigger calculations under §141.859(a). 

(1) The State may waive the requirement to collect three routine samples the next month in 

which the system provides water to the public if the State, or an agent approved by the State, 

performs a site visit before the end of the next month in which the system provides water to the 

public. Although a sanitary survey need not be performed, the site visit must be sufficiently 

detailed to allow the State to determine whether additional monitoring and/or any corrective 

action is needed. The State cannot approve an employee of the system to perform this site visit, 

even if the employee is an agent approved by the State to perform sanitary surveys.

(2) The State may waive the requirement to collect three routine samples the next month in 

which the system provides water to the public if the State has determined why the sample was 

total coliform-positive and has established that the system has corrected the problem or will 
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correct the problem before the end of the next month in which the system serves water to the 

public. In this case, the State must document this decision to waive the following month's 

additional monitoring requirement in writing, have it approved and signed by the supervisor of 

the State official who recommends such a decision, and make this document available to the 

EPA and public. The written documentation must describe the specific cause of the total 

coliform-positive sample and what action the system has taken and/or will take to correct this 

problem. 

(3) The State may not waive the requirement to collect three additional routine samples the next 

month in which the system provides water to the public solely on the grounds that all repeat 

samples are total coliform-negative. If the State determines that the system has corrected the 

contamination problem before the system takes the set of repeat samples required in §141.858, 

and all repeat samples were total coliform-negative, the State may waive the requirement for 

additional routine monitoring the next month.

§ 141.855 Routine monitoring requirements for community water systems serving 1,000 or 

fewer people using only ground water.

(a) General. (1) The provisions of this section apply to community water systems using only 

ground water (except ground water under the direct influence of surface water, as defined in 

§141.2) and serving 1,000 or fewer people.

(2) Following any total coliform-positive sample taken under the provisions of this section, 

systems must comply with the repeat monitoring requirements and E. coli analytical 

requirements in § 141.858.
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(3) Once all monitoring required by this section and § 141.858 for a calendar month has been 

completed, systems must determine whether any coliform treatment technique triggers specified 

in § 141.859 have been exceeded. If any trigger has been exceeded, systems must complete 

assessments as required by § 141.859.

(b) Monitoring frequency for total coliforms. The monitoring frequency for total coliforms is 

one sample/month, except as provided for under paragraphs (c) through (f) of this section. 

(c) Transition to subpart Y. (1) All systems must continue to monitor according to the total 

coliform monitoring schedules under § 141.21 that were in effect on March 31, 2016[DATE 

THREE YEARS AFTER PUBLICATION OF THE FINAL RULE] unless any of the 

conditions in paragraph (e) of this section are triggered on or after April 1, 2016[DATE THREE 

YEARS AFTER PUBLICATION OF THE FINAL RULE] or unless otherwise directed by 

the State.

(2) After Beginning April 1, 2016[DATE THREE YEARS AFTER PUBLICATION OF 

THE FINAL RULE], the State must perform a special monitoring evaluation during each 

sanitary survey to review the status of the system, including the distribution system, to determine 

whether the system is on an appropriate monitoring schedule. After the State has performed the 

special monitoring evaluation during each sanitary survey, the State may modify the system’s 

monitoring schedule, as necessary, or it may allow the system to stay on its existing monitoring 

schedule, consistent with the provisions of this section. The State may not allow systems to 

begin less frequent reduce monitoring under the special monitoring evaluation unless the system 

has already met the applicable criteria for less frequent reduced monitoring in this section. 

(d) Criteria for reduced monitoring. (1) The State may reduce the monitoring frequency from 

monthly monitoring to no less than quarterly monitoring if the system is in compliance with 

Comment [EPA236]: EPA ok with 

this OMB clarification.

Comment [EPA237]: Edit to parallel 

suggested edit in 141.854(c)(2). If 

141.54(c)(2) is further edited, this also 

needs to be edited.
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State-certified operator provisions and demonstrates that it meets the criteria in paragraphs 

(d)(1)(i) through (d)(1)(iii) of this section. A system that loses its certified operator must return 

to monthly monitoring the month following that loss. 

(i) The system has a clean compliance history for a minimum of 12 months.

(ii) The most recent sanitary survey shows the system is free of sanitary defects (or has an 

approved plan and schedule to correct them and is in compliance with the plan and the 

schedule), has a protected water source and meets approved construction standards.

(iii) The system meets at least one of the following criteria: 

(A) An annual site visit by the State that is equivalent to a Level 2 assessment or an annual Level 

2 assessment by a party approved by the State and correction of all identified sanitary defects (or 

an approved plan and schedule to correct them and is in compliance with the plan and schedule).

(B) Cross connection control, as approved by the State.

(C) Continuous disinfection entering the distribution system and a residual in the distribution 

system in accordance with criteria specified by the State.

(D) Demonstration of maintenance of at least a 4-log removal or inactivation of viruses as 

provided for under § 141.403(b)(3).

(E) Other equivalent enhancements to water system barriers as approved by the State. 

(e) Return to routine monthly monitoring requirements. Systems on quarterly monitoring that 

experience any of the events in paragraphs (e)(1) through (e)(4) of this section must begin 

monthly monitoring the month following the event. The system must continue monthly 

monitoring until it meets the reduced monitoring requirements in paragraph (d) of this section.

(1) The system triggers a Level 2 assessment or two Level 1 assessments in a rolling 12-month 

period.
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(2) The system has an E. coli MCL violation.

(3) The system has a coliform treatment technique violation.

(4) The system has two subpart Y monitoring violations in a rolling 12-month period. 

(f) Additional routine monitoring the month following a total coliform-positive sample. Systems 

collecting samples on a quarterly frequency must conduct additional routine monitoring the 

month following one or more total coliform-positive samples (with or without a Level 1 

treatment technique trigger). Systems must collect at least three routine samples during the next 

month, except that the State may waive this requirement if the conditions of paragraph (f)(1), (2), 

or (3) of this section are met. Systems may either collect samples at regular time intervals 

throughout the month or may collect all required routine samples on a single day if samples are 

taken from different sites. Systems must use the results of additional routine samples in coliform 

treatment technique trigger calculations. 

(1) The State may waive the requirement to collect three routine samples the next month in 

which the system provides water to the public if the State, or an agent approved by the State, 

performs a site visit before the end of the next month in which the system provides water to the 

public. Although a sanitary survey need not be performed, the site visit must be sufficiently 

detailed to allow the State to determine whether additional monitoring and/or any corrective 

action is needed. The State cannot approve an employee of the system to perform this site visit, 

even if the employee is an agent approved by the State to perform sanitary surveys.

(2) The State may waive the requirement to collect three routine samples the next month in 

which the system provides water to the public if the State has determined why the sample was 

total coliform-positive and has established that the system has corrected the problem or will 

correct the problem before the end of the next month in which the system serves water to the 
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public. In this case, the State must document this decision to waive the following month's 

additional monitoring requirement in writing, have it approved and signed by the supervisor of 

the State official who recommends such a decision, and make this document available to the 

EPA and the public. The written documentation must describe the specific cause of the total 

coliform-positive sample and what action the system has taken and/or will take to correct this 

problem. 

(3) The State may not waive the requirement to collect three additional routine samples the next 

month in which the system provides water to the public solely on the grounds that all repeat 

samples are total coliform-negative. If the State determines that the system has corrected the 

contamination problem before the system takes the set of repeat samples required in § 141.858, 

and all repeat samples were total coliform-negative, the State may waive the requirement for 

additional routine monitoring the next month.

§ 141.856 Routine monitoring requirements for subpart H public water systems serving 

1,000 or fewer people.

(a) General. (1) The provisions of this section apply to subpart H public water systems of this 

part serving 1,000 or fewer people.

(2) Following any total coliform-positive sample taken under the provisions of this section, 

systems must comply with the repeat monitoring requirements and E. coli analytical 

requirements in § 141.858.

(3) Once all monitoring required by this section and § 141.858 for a calendar month has been 

completed, systems must determine whether any coliform treatment technique triggers specified 
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in § 141.859 have been exceeded. If any trigger has been exceeded, systems must complete 

assessments as required by § 141.859.

(4) Seasonal systems. (i) Beginning April 1, 2016[DATE THREE YEARS AFTER 

PUBLICATION OF THE FINAL RULE], all seasonal systems must demonstrate completion 

of a State-approved start-up procedure, which may include a requirement for start-up sampling 

prior to serving water to the public.

(ii) The State may exempt any seasonal system from some or all of the requirements for 

seasonal systems if the entire distribution system remains pressurized during the entire period 

that the system is not operating.

(b) Routine monitoring frequency for total coliforms. Subpart H systems of this part (including 

consecutive systems) must monitor monthly. Systems may not reduce monitoring.

(c) Unfiltered subpart H systems. A subpart H system of this part that does not practice 

filtration in compliance with subparts H, P, T, and W must collect at least one total coliform 

sample near the first service connection each day the turbidity level of the source water, 

measured as specified in § 141.74(b)(2), exceeds 1 NTU. When one or more turbidity 

measurements in any day exceed 1 NTU, the system must collect this coliform sample within 24 

hours of the first exceedance, unless the State determines that the system, for logistical reasons 

outside the system's control, cannot have the sample analyzed within 30 hours of collection and 

identifies an alternative sample collection schedule. Sample results from this coliform 

monitoring must be included in determining whether the coliform treatment technique trigger in 

§ 141.859 has been exceeded.
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§ 141.857 Routine monitoring requirements for public water systems serving more than 

1,000 people.

(a) General. (1) The provisions of this section apply to public water systems serving more than 

1,000 persons.

(2) Following any total coliform-positive sample taken under the provisions of this section, 

systems must comply with the repeat monitoring requirements and E. coli analytical 

requirements in § 141.858.

(3) Once all monitoring required by this section and § 141.858 for a calendar month has been 

completed, systems must determine whether any coliform treatment technique triggers specified 

in § 141.859 have been exceeded. If any trigger has been exceeded, systems must complete 

assessments as required by § 141.859.

(4) Seasonal systems. (i) Beginning April 1, 2016[DATE THREE YEARS AFTER 

PUBLICATION OF THE FINAL RULE], all seasonal systems must demonstrate completion 

of a State-approved start-up procedure, which may include a requirement for start-up sampling 

prior to serving water to the public.

(ii) The State may exempt any seasonal system from some or all of the requirements for 

seasonal systems if the entire distribution system remains pressurized during the entire period 

that the system is not operating.

(b) Monitoring frequency for total coliforms. The monitoring frequency for total coliforms is 

based on the population served by the system, as follows:

Total Coliform Monitoring Frequency for Public

Water Systems Serving More Than 1,000 People
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 Minimum number of

Population served samples per month

1,001 to 2,500............................2

2,501 to 3,300............................3

3,301 to 4,100............................4

4,101 to 4,900............................5

4,901 to 5,800............................6

5,801 to 6,700............................7

6,701 to 7,600............................8

7,601 to 8,500............................9

8,501 to 12,900........................10

12,901 to 17,200......................15

17,201 to 21,500......................20

21,501 to 25,000......................25

25,001 to 33,000......................30

33,001 to 41,000......................40

41,001 to 50,000......................50

50,001 to 59,000......................60

59,001 to 70,000......................70

70,001 to 83,000......................80

83,001 to 96,000......................90

96,001 to 130,000..................100

130,001 to 220,000................120

220,001 to 320,000................150

320,001 to 450,000................180

450,001 to 600,000................210

600,001 to 780,000................240

780,001 to 970,000................270

970,001 to 1,230,000.............300

1,230,001 to 1,520,000..........330

1,520,001 to 1,850,000..........360

1,850,001 to 2,270,000..........390

2,270,001 to 3,020,000..........420

3,020,001 to 3,960,000..........450

3,960,001 or more..................480

(c) Unfiltered subpart H systems. A subpart H system of this part that does not practice 

filtration in compliance with subparts H, P, T, and W must collect at least one total coliform 

sample near the first service connection each day the turbidity level of the source water, 

measured as specified in § 141.74(b)(2), exceeds 1 NTU. When one or more turbidity 

measurements in any day exceed 1 NTU, the system must collect this coliform sample within 24 
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hours of the first exceedance, unless the State determines that the system, for logistical reasons 

outside the system's control, cannot have the sample analyzed within 30 hours of collection and 

identifies an alternative sample collection schedule. Sample results from this coliform 

monitoring must be included in determining whether the coliform treatment technique trigger in 

§ 141.859 has been exceeded.

(d) Reduced monitoring. Systems may not reduce monitoring, except for non-community water 

systems using only ground water (and not ground water under the direct influence of surface 

water) serving 1,000 or fewer people in some months and more than 1,000 persons in other 

months. In months when more than 1,000 persons are served, the systems must monitor at the 

frequency specified in paragraph (a) of this section. In months when 1,000 or fewer people are 

served, the State may reduce the monitoring frequency, in writing, to a frequency allowed under 

§ 141.854 for a similarly situated system that always serves 1,000 or fewer people, taking into 

account the provisions in § 141.854(e) through (g).

§ 141.858 Repeat monitoring and E. coli requirements.

(a) Repeat monitoring. (1) If a sample taken under §§ 141.854 though 141.857 is total coliformpositive, the system must collect a set of repeat samples within 24 hours of being notified of the 

positive result. The system must collect no fewer than three repeat samples for each total 

coliform-positive sample found. The State may extend the 24-hour limit on a case-by-case basis 

if the system has a logistical problem in collecting the repeat samples within 24 hours that is 

beyond its control. Alternatively, the State may implement criteria for the system to use in lieu 

of case-by-case extensions. In the case of an extension, the State must specify how much time 
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the system has to collect the repeat samples. The State cannot waive the requirement for a system 

to collect repeat samples in paragraphs (a)(1) through (a)(3) of this section.

(2) The system must collect all repeat samples on the same day, except that the State may allow a 

system with a single service connection to collect the required set of repeat samples over a threeday period or to collect a larger volume repeat sample(s) in one or more sample containers of any 

size, as long as the total volume collected is at least 300 ml.

(3) The system must collect an additional set of repeat samples in the manner specified in 

paragraphs (a)(1) through (a)(3) of this section if one or more repeat samples in the current set of 

repeat samples is total coliform-positive. The system must collect the additional set of repeat 

samples within 24 hours of being notified of the positive result, unless the State extends the limit 

as provided in paragraph (a)(1) of this section. The system must continue to collect additional 

sets of repeat samples until either total coliforms are not detected in one complete set of repeat 

samples or the system determines that a coliform treatment technique trigger specified in 

§141.859(a) has been exceeded as a result of a repeat sample being total coliform-positive and 

notifies the State. If a trigger identified in § 141.859 is exceeded as a result of a routine sample 

being total coliform-positive, systems are required to conduct only one round of repeat 

monitoring for each total coliform-positive routine sample.

(4) After a system collects a routine sample and before it learns the results of the analysis of that 

sample, if it collects another routine sample(s) from within five adjacent service connections of 

the initial sample, and the initial sample, after analysis, is found to contain total coliforms, then 

the system may count the subsequent sample(s) as a repeat sample instead of as a routine sample.
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(5) Results of all routine and repeat samples taken under §§ 141.854 through 141.858 not 

invalidated by the State must be used to determine whether a coliform treatment technique 

trigger specified in § 141.859 has been exceeded.

(b) Escherichia coli (E. coli) testing. (1) If any routine or repeat sample is total coliform-positive, 

the system must analyze that total coliform-positive culture medium to determine if E. coli are 

present. If E. coli are present, the system must notify the State by the end of the day when the 

system is notified of the test result, unless the system is notified of the result after the State office 

is closed and the State does not have either an after-hours phone line or an alternative 

notification procedure, in which case the system must notify the State before the end of the next 

business day.

(2) The State has the discretion to allow a system, on a case-by-case basis, to forgo E. coli testing 

on a total coliform-positive sample if that system assumes that the total coliform-positive sample 

is E. coli-positive. Accordingly, the system must notify the State as specified in paragraph (b)(1) 

of this section and the provisions of § 141.63(c) apply.

§ 141.859 Coliform treatment technique triggers and assessment requirements for 

protection against potential fecal contamination.

(a) Treatment technique triggers. Systems must conduct assessments in accordance with 

paragraph (b) of this section after exceeding treatment technique triggers in paragraphs (a)(1) 

and (a)(2) of this section.

(1) Level 1 treatment technique triggers.

(i) For systems taking 40 or more samples per month, the system exceeds 5.0% total coliformpositive samples for the month.
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(ii) For systems taking fewer than 40 samples per month, the system has two or more total 

coliform-positive samples in the same month. 

(iii) The system fails to take every required repeat sample after any single total coliform-positive 

sample.

(2) Level 2 treatment technique triggers.

(i) An E. coli MCL violation, as specified in § 141.860(a).

(ii) A second Level 1 trigger as defined in paragraph (a)(1) of this section, within a rolling 12-

month period, unless the State has determined a likely reason that the samples that caused the 

first Level 1 treatment technique trigger were total coliform-positive and has established that the 

system has corrected the problem.

(iii) For systems with approved annual monitoring, a Level 1 trigger in two consecutive years.

(b) Requirements for assessments. (1) Systems must ensure that Level 1 and 2 assessments are 

conducted in order to identify the possible presence of sanitary defects and defects in distribution 

system coliform monitoring practices. Level 2 assessments must be conducted by parties 

approved by the State.

(2) When conducting assessments, systems must ensure that the assessor evaluates minimum 

elements that include review and identification of inadequacies in sample sites; sampling 

protocol; sample processing; atypical events that could affect distributed water quality or indicate 

that distributed water quality was impaired; changes in distribution system maintenance and 

operation that could affect distributed water quality (including water storage); source and 

treatment considerations that bear on distributed water quality, where appropriate (e.g., small 

ground water systems); and existing water quality monitoring data. The system must conduct the 
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assessment consistent with any State directives that tailor specific assessment elements with 

respect to the size and type of the system and the size, type, and characteristics of the distribution 

system.

(3) Level 1 Assessments. A system must conduct a Level 1 assessment consistent with State 

requirements if the system exceeds one of the treatment technique triggers in paragraph (a)(1) of 

this section.

(i) The system must complete a Level 1 assessment as soon as practical after any trigger in 

paragraph (a)(1) of this section. In the completed assessment form, the system must describe 

sanitary defects detected, corrective actions completed, and a proposed timetable for any 

corrective actions not already completed. The assessment form may also note that no sanitary 

defects were identified. The system must submit the completed Level 1 assessment form to the 

State within 30 days after the system learns that it has exceeded a trigger.

(ii) If the State reviews the completed Level 1 assessment and determines that the assessment is 

not sufficient (including any proposed timetable for any corrective actions not already 

completed), the State must consult with the system. If the State requires revisions after 

consultation, the system must submit a revised assessment form to the State on an agreed-upon 

schedule not to exceed 30 days from the date of the consultation. 

(iii) Upon completion and submission of the assessment form by the system, the State must 

determine if the system has identified a likely cause for the Level 1 trigger and, if so, establish 

that the system has corrected the problem, or has included a schedule acceptable to the State for 

correcting the problem.

(4) Level 2 Assessments. A system must ensure that a Level 2 assessment consistent with State 

requirements is conducted if the system exceeds one of the treatment technique triggers in 
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paragraph (a)(2) of this section. The system must comply with any expedited actions or 

additional actions required by the State in the case of an E. coli MCL violation. 

(i) The system must ensure that a Level 2 assessment is completed by the State or by a party 

approved by the State as soon as practical after any trigger in paragraph (a)(2) of this section. 

The system must submit a completed Level 2 assessment form to the State within 30 days after 

the system learns that it has exceeded a trigger. The assessment form must describe sanitary 

defects detected, corrective actions completed, and a proposed timetable for any corrective 

actions not already completed. The assessment form may also note that no sanitary defects were 

identified. 

(ii) The system may conduct Level 2 assessments if the system has staff or management with the 

certification or qualifications specified by the State unless otherwise directed by the State. 

(iii) If the State reviews the completed Level 2 assessment and determines that the assessment is 

not sufficient (including any proposed timetable for any corrective actions not already 

completed), the State must consult with the system. If the State requires revisions after 

consultation, the system must submit a revised assessment form to the State on an agreed-upon 

schedule not to exceed 30 days. 

(iv) Upon completion and submission of the assessment form by the system, the State must 

determine if the system has identified a likely cause for the Level 2 trigger and determine 

whether the system has corrected the problem, or has included a schedule acceptable to the State 

for correcting the problem.

(c) Corrective Action. Systems must correct sanitary defects found through either Level 1 or 2 

assessments conducted under paragraph (b) of this section. For corrections not completed by the 

time of submission of the assessment form, the system must complete the corrective action(s) in 
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compliance with a timetable approved by the State in consultation with the system. The system 

must notify the State when each scheduled corrective action is completed. 

(d) Consultation. At any time during the assessment or corrective action phase, either the water 

system or the State may request a consultation with the other party to determine the appropriate 

actions to be taken. The system may consult with the State on all relevant information that may 

impact on its ability to comply with a requirement of this subpart, including the method of 

accomplishment, an appropriate timeframe, and other relevant information.

§ 141.860 Violations.

(a) E. coli MCL Violation. A system is in violation of the MCL for E. coli when any of the 

conditions identified in paragraphs (a)(1) through (a)(4) of this section occur. 

(1) The system has an E. coli-positive repeat sample following a total coliform-positive routine 

sample.

(2) The system has a total coliform-positive repeat sample following an E. coli-positive routine 

sample.

(3) The system fails to take all required repeat samples following an E. coli-positive routine 

sample.

(4) The system fails to test for E. coli when any repeat sample tests positive for total coliform.

(b) Treatment technique violation. (1) A treatment technique violation occurs when a system 

exceeds a treatment technique trigger specified in § 141.859(a) and then fails to conduct the 

required assessment or corrective actions within the timeframe specified in § 141.859(b) and (c).

(2) A treatment technique violation occurs when a seasonal system fails to complete a Stateapproved start-up procedure prior to serving water to the public. 

(c) Monitoring violations. (1) Failure to take every required routine or additional routine 

sample in a compliance period is a monitoring violation. 
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(2) Failure to analyze for E. coli following a total coliform-positive routine sample is a 

monitoring violation.

(d) Reporting violations. (1) Failure to submit a monitoring report or completed assessment 

form after a system properly conducts monitoring or assessment in a timely manner is a reporting 

violation. 

(2) Failure to notify the State following an E. coli-positive sample as required by § 

141.858(b)(1) in a timely manner is a reporting violation.

(3) Failure to submit certification of completion of State-approved start-up procedure by a 

seasonal system is a reporting violation.

§ 141.861 Reporting and recordkeeping.

(a) Reporting. (1) E. coli.

(i) A system must notify the State by the end of the day when the system learns of an E. coli 

MCL violation, unless the system learns of the violation after the State office is closed and the 

State does not have either an after-hours phone line or an alternative notification procedure, in 

which case the system must notify the State before the end of the next business day, and notify 

the public in accordance with subpart Q of this part.

(ii) A system must notify the State by the end of the day when the system is notified of an E. 

coli-positive routine sample, unless the system is notified of the result after the State office is 

closed and the State does not have either an after-hours phone line or an alternative notification 

procedure, in which case the system must notify the State before the end of the next business 

day.
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(2) A system that has violated the treatment technique for coliforms in § 141.859 must report the 

violation to the State no later than the end of the next business day after it learns of the violation, 

and notify the public in accordance with subpart Q of this part. 

(3) A system required to conduct an assessment under the provisions of §141.859 of this part 

must submit the assessment report within 30 days. The system must notify the State in 

accordance with § 141.859(c) when each scheduled corrective action is completed for 

corrections not completed by the time of submission of the assessment form.

(4) A system that has failed to comply with a coliform monitoring requirement must report the 

monitoring violation to the State within 10 days after the system discovers the violation, and 

notify the public in accordance with subpart Q of this part.

(5) A seasonal system must certify, prior to serving water to the public, that it has complied 

with the State-approved start-up procedure.

(b) Recordkeeping. (1) The system must maintain any assessment form, regardless of who 

conducts the assessment, and documentation of corrective actions completed as a result of those 

assessments, or other available summary documentation of the sanitary defects and corrective 

actions taken under § 141.858 for State review. This record must be maintained by the system 

for a period not less than five years after completion of the assessment or corrective action. 

(2) The system must maintain a record of any repeat sample taken that meets State criteria for an 

extension of the 24-hour period for collecting repeat samples as provided for under 

§141.858(a)(1) of this part.

PART 142 – NATIONAL PRIMARY DRINKING WATER REGULATIONS 

IMPLEMENTATION
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21. The authority citation for part 142 continues to read as follows:

Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-4, 300j-9, 

and 300j-11.

22. Section 142.14 is amended by revising paragraph (a)(1)(iii) and adding a new paragraph 

(a)(10) to read as follows:

§ 142.14 Records kept by States. 

(a) ***

(1) ***

(iii) The analytical results, set forth in a form that makes possible comparison with the limits 

specified in §§ 141.63, 141.71, and 141.72 of this chapter and with the limits specified in subpart 

Y of this chapter. 

*****

(10) Records of each of the following decisions made pursuant to the provisions of subpart Y of 

part 141 must be made in writing and retained by the State.

(i) Records of the following decisions or activities must be retained for five years.

(A) Sections 141.858(a), 141.853(c)(2), 141.856(c), and 141.857(c) of this chapter - Any caseby-case decision to waive the 24-hour time limit for collecting repeat samples after a total 

coliform-positive routine sample, or to extend the 24-hour limit for collection of samples 

following invalidation, or for an unfiltered subpart H system of this part to collect a total 

coliform sample following a turbidity measurement exceeding 1 NTU.
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(B) Sections 141.854(j) and 141.855(f) of this chapter – Any decision to allow a system to waive 

the requirement for three routine samples the month following a total coliform-positive sample. 

The record of the waiver decision must contain all the items listed in those sections.

(C) Section 141.853(c) of this chapter – Any decision to invalidate a total coliform-positive 

sample. If the decision to invalidate a total coliform-positive sample as provided in 

§141.853(c)(1) of this chapter is made, the record of the decision must contain all the items listed 

in that section.

(D) Section 141.859 of this chapter – Completed and approved subpart Y assessments, including 

reports from the system that corrective action has been completed as required by § 141.861(a)(2) 

of this chapter.

(ii) Records of each of the following decisions must be retained in such a manner so that each 

system’s current status may be determined:

(A) Section 141.854(e) of this chapter – Any decision to reduce the total coliform monitoring 

frequency for a non-community water system using only ground water and serving 1,000 or 

fewer people to less than once per quarter, as provided in § 141.854(e) of this chapter, including 

what the reduced monitoring frequency is. A copy of the reduced monitoring frequency must be 

provided to the system.

(B) Section 141.855(d) of this chapter – Any decision to reduce the total coliform monitoring 

frequency for a community water system serving 1,000 or fewer people to less than once per 

month, as provided in § 141.855(d) of this chapter, including what the reduced monitoring 

frequency is. A copy of the reduced monitoring frequency must be provided to the system.

(C) Section 141.857(d) of this chapter – Any decision to reduce the total coliform monitoring 

frequency for a non-community water system using only ground water and serving more than 
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1,000 persons during any month the system serves 1,000 or fewer people, as provided in § 

141.857(d) of this chapter. A copy of the reduced monitoring frequency must be provided to the 

system.

(D) Section 141.858(b)(2) of this chapter – Any decision to allow a system to forgo E. coli 

testing of a total coliform-positive sample if that system assumes that the total coliform-positive 

sample is E. coli- positive.

*****

23. Section 142.15 is amended by adding paragraph (c)(3) to read as follows: 

§ 142.15 Reports by States.

*****

(c) ***

(3) Total coliforms under subpart Y. A list of systems that the State is allowing to monitor less 

frequently than once per month for community water systems or less frequently than once per 

quarter for non-community water systems as provided in §§141.855 and 141.854 of this chapter, 

including the applicable date of the reduced monitoring requirement for each system.

*****

24. Section 142.16 is amended by adding a new paragraph (q) to read as follows:

§ 142.16 Special primacy requirements.

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(q) Requirements for States to adopt 40 CFR part 141 subpart Y – Revised Total Coliform Rule. 

In addition to the general primacy requirements elsewhere in this part, including the 

requirements that State regulations be at least as stringent as federal requirements, an application 

for approval of a State program revision that adopts 40 CFR part 141, subpart Y, must contain 

the information specified in this paragraph (q).

(1) In their application to EPA for approval to implement the federal requirements, the primacy 

application must indicate what baseline and reduced monitoring provisions of 40 CFR part 141, 

subpart Y the State will adopt and must describe how they will implement 40 CFR part 141, 

subpart Y in these areas so that EPA can be assured that implementation plans meet the 

minimum requirements of the rule.

(2) The State’s application for primacy for subpart Y must include a written description for each 

provision included in paragraphs (q)(2)(i) through (viii) of this section.

(i) Sample Siting Plans - The frequency and process used to review and revise sample siting 

plans in accordance with 40 CFR part 141, subpart Y to determine adequacy. 

(ii) Reduced Monitoring Criteria – An indication of whether the State will adopt the reduced 

monitoring provisions of 40 CFR part 141, subpart Y. If the State adopts the reduced monitoring 

provisions, it must describe the specific types or categories of water systems that will be covered 

by reduced monitoring and whether the State will use all or a reduced set of the optional criteria. 

For each of the reduced monitoring criteria, both mandatory and optional, the State must describe 

how the criteria will be evaluated to determine when systems qualify.

(iii) Assessments and Corrective Actions – The process for implementing the new assessment 

and corrective action phase of the rule, including the elements in paragraphs (q)(2)(iii)(A) 

through (D) of this section.
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(A) Elements of Level 1 and Level 2 assessments. This must include an explanation of how the 

State will ensure that Level 2 assessments provide a more detailed examination of the system 

(including the system’s monitoring and operational practices) than do Level 1 assessments 

through the use of more comprehensive investigation and review of available information, 

additional internal and external resources, and other relevant practices.

(B) Examples of sanitary defects.

(C) Examples of assessment forms or formats.

(D) Methods that systems may use to consult with the State on appropriate corrective actions.

(iv) Invalidation of routine and repeat samples collected under 40 CFR part 141, subpart Y – The 

criteria and process for invalidating total coliform and E. coli-positive samples under 40 CFR 

part 141, subpart Y. This description must include criteria to determine if a sample was 

improperly processed by the laboratory, reflects a domestic or other non-distribution system 

plumbing problem or reflects circumstances or conditions that do not reflect water quality in the 

distribution system. 

(v) Approval of individuals allowed to conduct Level 2 assessments under 40 CFR part 141, 

subpart Y – The criteria and process for approval of individuals allowed to conduct Level 2 

assessments under 40 CFR part 141, subpart Y.

(vi) Special monitoring evaluation – The procedure for performing special monitoring 

evaluations during sanitary surveys for ground water systems serving 1,000 or fewer people to 

determine whether systems are on an appropriate monitoring schedule.

(vii) Seasonal systems – How the State will identify seasonal systems, how the State will 

determine when systems on less than monthly monitoring must monitor, and what start-up 

provisions seasonal system must meet under 40 CFR part 141, subpart Y.
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(viii) Additional criteria for reduced monitoring – How the State will require systems on reduced 

monitoring to demonstrate:

(A) Continuous disinfection entering the distribution system and a residual in the distribution 

system.

(B) Cross connection control.

(C) Other enhancements to water system barriers.

(ix) Criteria for extending the 24-hour period for collecting repeat samples. – Under §§

141.858(a) and 141.853(c)(2) of this chapter, criteria for systems to use in lieu of case-by-case 

decisions to waive the 24-hour time limit for collecting repeat samples after a total coliformpositive routine sample, or to extend the 24-hour limit for collection of samples following 

invalidation. If the State elects to use only case-by-case waivers, the State does not need to 

develop and submit criteria.

25. Section 142.63 is amended by revising paragraph (b) to read as follows: 

§ 142.63 Variances and exemptions from the maximum contaminant level for total 

coliforms.

*****

(b) EPA has stayed this section as it relates to the total coliform MCL of §141.63(a) of this 

chapter for systems that demonstrate to the State that the violation of the total coliform MCL is 

due to a persistent growth of total coliforms in the distribution system rather than fecal or 

pathogenic contamination, a treatment lapse or deficiency, or a problem in the operation or 

maintenance of the distribution system. This stay is applicable until [DATE THREE YEARS 
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AFTER PUBLICATION OF THE FINAL RULE]March 31, 2016, at which time the total 

coliform MCL is no longer applicable.