Form for Compliance with E.O. 12866 Docket Requirements

 

Title of Regulation: National Primary Drinking Water Regulations: Revisions to the Total 

Coliform Rule 

Contact person: Sean Conley 

 

Phone number: 202-564-1781 

Was this regulation reviewed by OMB under Executive Order 12866 - Regulatory Planning 

and Review? 

( 9 ) Yes ( ) No 

If you checked “no”, you are done with this form. Simply place it in the docket for your 

regulation. If you checked “yes”, please fill out the remainder of the form before placing it in 

the docket. Also docket any relevant documents referenced in the form. 

For regulations that are checked “Yes” above: 

This regulation was reviewed by OMB under Executive Order 12866 - Regulatory Planning and 

Review. 

Attached is the draft regulation and any other documents sent to OMB for review, such as 

analyses and assessments. E.O. 12866 requires agencies to make these publicly available. 

E.O. 12866 also requires agencies to identify the substantive changes between the draft 

regulation sent to OMB for review and the regulation subsequently announced [Please check the 

appropriate box below:] 

 

 EPA made substantive changes to this regulation 

(includes changes initiated by EPA or OMB). 

Attached is a document which: (1) identifies all the substantive changes made, and (2) 

notes those changes OMB suggested or recommended. 

 

 9 No substantive changes were made to this regulation

 Therefore, no further attachments are required. 

If you have questions about this regulation, please call the EPA contact person listed above. 

Revised January 2009 
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ENVIRONMENTAL PROTECTION AGENCY 

40 CFR Parts 141 and 142 

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

RIN 2040-AD94

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

AGENCY: Environmental Protection Agency (EPA). 

ACTION: Proposed Rule. 

 

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

revisions to the 1989 Total Coliform Rule. The proposed Revised Total Coliform Rule offers a 

meaningful opportunity for greater public health protection beyond the current Total Coliform 

Rule. The proposed 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. 

EPA is also proposing to revise portions of the Ground Water Rule triggered source monitoring 

requirements as a result of the proposed Revised Total Coliform Rule repeat sample requirement. 

These proposed revisions are in accordance with the Safe Drinking Water Act as amended, 

which requires EPA to review and revise, as appropriate, each national primary drinking water 

regulation promulgated under the Safe Drinking Water Act not less often than every six years. 

As with the current Total Coliform Rule, the proposed Revised Total Coliform Rule applies to all 

public water systems. 

DATES: Comments must be received on or before [INSERT DATE 60 DAYS AFTER DATE 

OF PUBLICATION IN THE FEDERAL REGISTER]. 
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ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-2008-0878, 

by one of the following methods: 

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions 

for submitting comments. 

• E-mail: OW-Docket@epa.gov, Attention Docket ID No. EPA-HQ-OW-2008-0878 

• Mail: Water Docket, Environmental Protection Agency, Mailcode: 4101T, 1200 

Pennsylvania Ave., NW, Washington, DC 20460, Attention Docket ID No. EPA-HQOW-2008-0878. In addition, please mail a copy of your comments on the information 

collection provisions to the Office of Information and Regulatory Affairs, Office of 

Management and Budget (OMB), Attn: Desk Officer for EPA, 725 17th St., NW, 

Washington, DC 20503. 

• Hand Delivery: EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301 

Constitution Ave., NW, Washington, DC. Such deliveries are only accepted during the 

Docket’s normal hours of operation, and special arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2008-0878. EPA’s policy 

is that all comments received will be included in the public docket without change and may be 

made available online at http://www.regulations.gov, including any personal information 

provided, unless the comment includes information claimed to be Confidential Business 

Information (CBI) or other information whose disclosure is restricted by statute. Do not submit 

information that you consider to be CBI or otherwise protected through 

http://www.regulations.gov, or e-mail. The http://www.regulations.gov website is an 

“anonymous access” system, which means EPA will not know your identity or contact 
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information unless you provide it in the body of your comment. If you send an e-mail comment 

directly to EPA without going through http://www.regulations.gov, your email address will be 

automatically captured and included as part of the comment that is placed in the public docket 

and made available on the Internet. If you submit an electronic comment, EPA recommends that 

you include your name and other contact information in the body of your comment and with any 

disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties 

and cannot contact you for clarification, EPA may not be able to consider your comment. 

Electronic files should avoid the use of special characters, any form of encryption, and be free of 

any defects or viruses. For additional information about EPA’s public docket, visit the EPA 

Docket Center homepage at http://www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the docket are listed in the http://www.regulations.gov index. 

Although listed in the index, some information is not publicly available, i.e., CBI or other 

information whose disclosure is restricted by statue. Certain other material, such as copyrighted 

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

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

EPA Docket Center, EPA/DC, EPA West, Room B102, 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), 

Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; 

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

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 §141.850(b) of this proposed rule. If you have questions regarding the applicability of 

this 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 
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This document is available for download at http://www.epa.gov/safewater/disinfection/tcr/. 

For other related information, see preceding discussion on docket. 

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 

AWOP Area Wide Optimization Program 

BAT Best Available Technology 

C Celsius 

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 

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 

MOU Memorandum of Understanding 

MRDL Maximum Residual Disinfectant Level 

MUG 4-methylumbelliferyl-Beta-D-glucuronide 
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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 

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 

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 

TNCWS Transient Non-Community Water System 

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 

II. Background 

A. Statutory Authority 

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

C. Other Outreach Processes 

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

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

2. Indicators 

3. Occurrence of fecal contamination and waterborne pathogens 

III. Proposed Revised Total Coliform Rule 

A. Proposed Rule Provisions and Rationale 

1. Terms used in the proposed RTCR 
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2. MCLG and MCL for E. coli, and coliform treatment technique 

3. Monitoring 

4. Repeat samples 

5. Treatment technique requirements 

6. Violations 

7. Providing notification and information to the public 

8. Reporting and recordkeeping requirements for systems 

9. Analytical methods 

B. Proposed Compliance Date 

C. Links to Other Drinking Water Rule Requirements 

1. SWTR, Stage 1 and Stage 2 DBPRs, ADWR 

2. GWR 

3. Sanitary surveys 

D. Best Available Technology (BAT) 

1. Provisions 

2. EPA’s rationale 

3. Request for comment 

E. Variances and Exemptions 

1. Provisions 

2. EPA’s rationale 

3. Request for comment 

F. Request for Comment on Other Issues Related to the Proposed RTCR 

1. Consistency between the proposed RTCR and the GWR 

2. Storage tank inspection and cleaning 

3. States under EPA direct implementation 

G. Limitations to the Public Comment on the Proposed RTCR 

IV. State Implementation 

A. State Special Primacy Requirements 

B. State Recordkeeping Requirements 

C. State Reporting Requirements 

D. Interim Primacy 

E. Request for Comment 

V. Distribution System Research and Information Collection Activities 

A. Research and Information Collection Partnership 

B. Distribution System Optimization Activities 

C. Request for Comment 

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 

1. Model used for public water systems serving 4,100 or fewer people 

2. Model used for public water systems serving more than 4,100 people 

D. Baseline Profiles 
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E. Anticipated Benefits of the Proposed RTCR 

1. Relative risk analysis 

2. Changes in violation rates and corrective actions 

3. Nonquantifiable benefits 

F. Anticipated Costs of the Proposed RTCR 

1. Total annualized present value costs 

2. PWS costs 

3. State costs 

4. Nonquantifiable costs 

G. Potential Impact of the Proposed 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 Proposed RTCR 

1. Inputs and their uncertainties 

2. Sensitivity analysis 

M. Benefit Cost Determination for the Proposed RTCR 

N. Request for Comment 

VII. Statutory and Executive Order Review 

A. Executive Order 12866: Regulatory Planning and 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 

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. Impacts on Sensitive Subpopulations as Required by Section 1412(b)(3)(C)(i) of the 1996 

Amendments of the Safe Drinking Water Act (SDWA) 

M. Plain Language 

VIII. References 

II. Background 

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

each existing national primary drinking water regulation (NPDWR) at least once every six years 

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

Total Coliform Rule (TCR) 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 healthrelated 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 (also 

referred to as the “current TCR”)..

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

In June 2007, EPA established the Total Coliform Rule/Distribution System Advisory 

Committee (“TCRDSAC” or “the advisory committee”) 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 distribution systems (USEPA 2007a, 72 FR 35869, June 29, 2007). The decision 

to include a review of distribution system issues was made, in part, to address recommendations 

made by the Stage 2 Microbial and Disinfection Byproducts Federal Advisory Committee in 

December 2000 (USEPA 2000b, 65 FR 83015, December 29, 2000). The TCRDSAC used 

available information to analyze options for revisions to the TCR. The TCRDSAC also 

considered research and information needed to better understand and address public health risks 

from contamination of distribution systems. 
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The advisory committee consisted of representatives of EPA, State and local public health 

and regulatory agencies, consumer organizations, environmental organizations, local elected 

officials, Indian Tribes, and drinking water suppliers. A technical workgroup was also formed to 

provide the advisory committee with necessary technical support and analysis to facilitate the 

committee’s discussions. The advisory committee met on 13 occasions between July 2007 and 

September 2008. All advisory committee members agreed to and signed the final Agreement in 

Principle (AIP) in September 2008. All of the recommendations of the advisory committee are 

found in the signed AIP. Pursuant to the AIP, EPA agreed to propose revisions to the TCR that, 

to the maximum extent consistent with EPA’s legal obligations, have the same substance and 

effect as the elements of the AIP. Each party represented on the advisory committee agreed in 

the AIP not to take any action to inhibit the adoption and implementation of final rule(s) to the 

extent it and the corresponding preamble have the same substance and effect as the elements of 

the AIP. EPA also agreed in the AIP to develop a Research and Information Collection 

Partnership (RICP) to “inform and support the drinking water community in developing future 

national risk management decisions pertaining to drinking water distribution systems” by 

providing “a formal process for systematic planning, implementation, analysis, and 

communication of distribution system research and information collection” (USEPA 2008c). A 

discussion of the RICP can be found in section V of this preamble. The AIP and details about 

the advisory committee can be found at EPA’s website at: 

http://www.epa.gov/safewater/disinfection/tcr/regulation_revisions.html. 

 In addition to the outreach mentioned above, EPA agreed to engage in various future 

stakeholder meetings at least annually, to which all advisory committee members and the public 

at large would be invited. In April 2009, EPA held its first annual stakeholder meeting to 
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provide draft proposed regulation updates and an opportunity for stakeholders to provide 

feedback on the development of the proposed RTCR. 

C. Other Outreach Processes 

In addition to consulting with the advisory committee, EPA engaged in several other 

activities as part of the Agency’s outreach to stakeholders in developing the proposed RTCR. 

EPA held a technical workshop in Washington, DC, from January 30 to February 1, 2007, to 

discuss available information on the current TCR and available information regarding risks in 

distribution systems in support of revisions to the TCR. Other EPA outreach activities, namely 

the National Drinking Water Advisory Council consultation, Science Advisory Board 

consultation, and the Tribal consultation, are discussed in section VII of this preamble. 

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

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

The proposed 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, reduced 
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kidney function, hypertension and reactive arthritis can result from infection by a waterborne 

agent (Clark et al. 2008). 

 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 

other means which are 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. 

2. Indicators 

Total coliforms are a group of closely related bacteria that, with 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. The absence (versus the presence) of total 
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coliforms in the distribution system indicates a reduced likelihood that fecal contamination 

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

Under the current 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 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 

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. 

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 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. The 

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

(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 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 

TCR. 
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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 (or one with amoebic meningoencephalitis) 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). 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 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, endemic refers to the persistent 

low to moderate level or the unusual ongoing occurrence of illness in a given population or 

geographic area (Craun et al. 2006). 

III. Proposed Revised Total Coliform Rule
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The proposed RTCR maintains and strengthens the objectives of the current 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 proposed revision 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 proposed RTCR compared to the current TCR because of its more 

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

The following is an overview of the key provisions of the proposed RTCR: 

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

fecal contamination. The proposed RTCR establishes a maximum contaminant level goal 

(MCLG) and maximum contaminant level (MCL) for E. coli. 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, will require 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.A.2 of this 

preamble for a detailed discussion on the MCLG, MCL, and treatment technique requirements. 

• Monitoring. As with the current 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 proposed RTCR must continue to be representative of the 

water throughout the distribution system. Under the proposed RTCR, systems have the 
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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 

current TCR of five connections upstream and downstream of the total coliform-positive sample 

location. 

As with the current TCR, the proposed RTCR allows reduced monitoring for some small 

ground water systems. The proposed RTCR is expected to improve public health protection 

compared to the current 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 TCR 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 proposed RTCR requires increased monitoring for 

high-risk systems that meet certain criteria such as unacceptable compliance history under the 

RTCR. The proposed 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 proposed RTCR requires systems on a quarterly or annual monitoring frequency 

(applicable only to ground water systems serving 1,000 or fewer people) to conduct additional 

routine monitoring the month following one or more total coliform-positive samples. Under the 

proposed RTCR, systems must collect at least three routine samples during the next month, 

unless the State waives the additional routine monitoring. This is a reduction in the required 
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number of additional routine samples from the current 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 current TCR requires all systems serving 1,000 or fewer people to collect at least four 

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

proposed rule requires three repeat samples after a routine total coliform-positive sample, 

regardless of the system type and size. 

See sections III.A.3 and III.A.4 of this preamble for detailed discussions of the routine 

monitoring and repeat sampling requirements of the proposed RTCR. 

• Seasonal systems. The proposed RTCR establishes monitoring requirements for seasonal 

systems for the first time. 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. Seasonal systems must demonstrate completion of a 

State-approved start-up procedure. In addition, they must designate the time period(s) for 

monitoring based on site-specific considerations (such as during periods of highest demand or 

highest vulnerability to contamination) in their State-approved sample siting plan. See section 

III.A.3 of this preamble for a detailed discussion of 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 a simple self-assessment (Level 1) or a more detailed 

assessment (Level 2) depending on the severity and frequency of contamination. The system is 

responsible for correcting any sanitary defect(s) found through either a Level 1 or Level 2 
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assessment. See section III.A.5 of this preamble for more discussion of the treatment technique 

requirement of the proposed RTCR. 

• Violations and public notification. The proposed 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 proposed RTCR also modifies 

the public notification and Consumer Confidence Report language to reflect the construct of the 

proposed rule. See sections III.A.6 and III.A.7 of this preamble for detailed discussions of 

violations and public notification under the proposed RTCR. 

• Transition to the RTCR. The proposed RTCR allows all systems to transition to the new rule 

at their current TCR monitoring frequency, including systems on reduced monitoring under the 

current TCR. States will then evaluate the monitoring frequency during each sanitary survey 

conducted after the compliance effective date of the RTCR. This process reduces State burden 

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

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

PWSs in the State. 

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

superseding 40 CFR 141.21 beginning three years following the publication of the final revised 

rule.

A. Proposed Rule Provisions and Rationale 

1. Terms used in the proposed RTCR 
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a. Provisions. i. Clean compliance history. For the purposes of the proposed RTCR, EPA 

is proposing to define “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 treatment technique trigger exceedances or treatment technique violations 

under subpart Y. 

ii. Sanitary defect. EPA is proposing to define “sanitary defect” 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” (USEPA 2008c). 

iii. Seasonal systems. EPA is proposing to define a seasonal system as a non-community 

water system that is operated three or fewer calendar quarters per calendar year. 

b. EPA’s rationale. i. Clean compliance history. EPA is proposing a definition of “clean 

compliance history” because without a definition, the use of the phrase could result in multiple 

interpretations. Clean compliance history is one of the criteria a system must meet to be eligible 

for reduced monitoring. The advisory committee recommended this definition (USEPA 2008c, 

AIP p. 10).

ii. Sanitary defect. The advisory committee recommended the definition of sanitary defect. 

The proposed RTCR takes a more preventive approach to protect public health by establishing a 

framework for the assessment of public water systems to identify sanitary defects and to correct 

them as appropriate. The first part of the proposed definition of a “sanitary defect” focuses on 

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. 
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Indications of failure or imminent failure of these barriers are defects that require corrective 

action. 

Sanitary defect is a term specific to the proposed RTCR assessment and corrective action 

provisions. Sanitary defects are not intended to be linked directly to “significant deficiencies” 

under the Surface Water Treatment Rule (SWTR) (USEPA 1989b, 54 FR 27486, June 29, 1989) 

and Ground Water Rule (GWR) (USEPA 2006c, 71 FR 65574, November 8, 2006), although 

some problems could meet either definition. Nothing in this proposed rule is intended to limit 

the existing authorities of States under other regulations. 

The following is a list of examples of sanitary defects and defects in the distribution system 

coliform monitoring practices (USEPA 2008c, AIP Appendix Y, p. 41). 

Examples of sanitary defects

• Cross connection and backflow issues such as a required backflow prevention device not in 

place or not operating properly; or an unprotected cross connection found. 

• Operator issues such as failure to follow standard operating procedures (SOPs) that protect 

distribution system integrity and sanitary conditions. 

• Distribution system issues such as inadequate inspection and maintenance of the distribution 

system; loss of distribution system integrity such as main breaks; failure to maintain adequate 

pressure; improper flushing operations; improper construction of new, replaced, or renovated 

lines; inadequate disinfection during and after repair/replacement activities; or inability to 

maintain required residual throughout the distribution system. 

• Storage issues such as overflow, vents, hatches, and other penetrations not properly 

configured, screened, or sealed; inadequate maintenance of storage facilities; or inadequate 

disinfection during and after repair/replacement activities. 
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• Disinfection issues such as inability to maintain required residual throughout the distribution 

system. 

iii. Seasonal systems. Seasonal systems fall under the broader category of non-community 

water systems (NCWS) and therefore are subject to provisions applicable to that category of 

systems. However, seasonal systems have unique characteristics and timetables that make them 

particularly susceptible to contamination. Seasonal systems represent a special case in that the 

shut down and start-up of the water system present opportunities for contamination to enter or 

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

can lead to intrusion of contaminants. 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. The advisory committee recommended 

that such provisions pertain to seasonal systems. See section III.A.3 of this preamble for specific 

provisions that seasonal systems must meet.

c. Request for comment. EPA requests comment on the proposed definitions and whether 

they work within the construct of the proposed RTCR. Specifically, EPA requests comment on 

the proposed definition of seasonal systems. The advisory committee recommended that 

seasonal systems be identified and be subject to additional regulatory requirements because the 

shutdown and startup of the system presents opportunities for contaminants to enter or spread 

through the distribution system. These results are possible in any system that shuts down and 
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does not maintain adequate pressure throughout the distribution system. EPA requests comment 

on whether the proposed definition of “seasonal system” is adequate to address this concern. For 

example, a system that operated from March to October would operate in all four calendar 

quarters and would not be considered a seasonal system, but would be subject to the same 

possibility of distribution system intrusion as a seasonal system that operated April to November 

(three calendar quarters). Should EPA modify the definition to address this issue? If so, how 

should the definition be modified? Should systems that close for some specified period (e.g., 30 

days, 60 days, 90 days) be subject to seasonal system requirements? What should that specified 

period be? 

Systems that operate intermittently (e.g., only on weekends or only when a camp is open) 

may also be subject to distribution system contamination due to lack of adequate pressure. 

Should this be addressed? If so, how should it be addressed – through regulation, guidance, or 

some other approach? Is there a specific shutdown time that should be considered for 

intermittent systems in developing the approach and determining which systems should be 

included? 

In addition to the public health benefits associated with these requirements, EPA is aware of 

the burden that States will have in determining which systems must comply and in tracking 

compliance. Therefore, EPA requests comment on ways to reduce State burden and facilitate 

implementation of seasonal system provisions. 

2. MCLG and MCL for E. coli, and coliform treatment technique 

a. Provisions. The current TCR established a maximum contaminant level goal (MCLG) of 

zero for total coliforms (including fecal coliforms and E. coli) and an MCL for total coliforms. 

EPA is proposing in the RTCR to eliminate the MCLG for total coliforms (including fecal 
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coliforms) and the MCL for total coliforms. Under the proposed RTCR, EPA establishes an 

MCLG of zero and an MCL for E. coli and a treatment technique for coliform. The proposed 

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. 

The proposed MCL is similar to the criteria that define the conditions (if exceeded) when a Tier 

1 acute MCL violation occurs under the current TCR but with two modifications. First, the 

proposed MCL excludes fecal coliforms. Second, the proposed MCL also includes an additional 

condition by which a system violates the MCL, namely failing to collect all repeat samples 

following an initial E. coli-positive sample. EPA is also proposing a coliform treatment 

technique, which uses total coliforms and E. coli as indicators of a possible breach in the 

distribution system that could lead to fecal contamination. 

b. EPA’s rationale. i. Inclusion of MCLG for E. coli and removal of MCLG for total 

coliforms (including fecal coliforms). EPA is proposing in the RTCR to include an MCLG of 

zero for E. coli and to remove the current MCLG of zero for total coliforms (including fecal 

coliforms). This is because E. coli is a more specific indicator of fecal contamination and 

potential harmful pathogens in drinking water than are total coliforms (including fecal 
Document initiating EO 12866 review 

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coliforms). 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 implication. See also the discussion of 

fecal coliforms in section III.A.9 of this preamble. New information has become available since 

promulgation of the current TCR in 1989 that indicates that measurement of fecal coliforms 

sometimes detects organisms that may not have any connection to fecal contamination (Edberg 

et al. 2000). An MCLG of zero for E. coli is more appropriate than an MCLG of zero for total 

coliforms (including fecal coliforms) since E. coli is a more specific indicator of the presence of 

fecal contamination. 

Total coliforms (including fecal coliforms) do not in and of themselves pose a public health 

risk, but they may indicate the presence of a pathway by which fecal contamination can occur. 

Therefore, the removal of the MCLG for total coliforms (including fecal coliforms) would 

prevent possible public confusion as a result of attributing greater public health significance to 

the presence of total coliforms than is warranted. EPA believes that the removal of the MCLG 

for total coliforms, along with the other proposed changes discussed in the succeeding 

paragraphs, leads to a rule that is more protective of public health, and is less confusing to the 

public. The proposed MCLG of zero for E. coli and the removal of the MCLG for total 

coliforms (including fecal coliforms) are also consistent with the recommendation made by the 

advisory committee in the AIP. 

ii. Inclusion of MCL for E. coli and removal of MCLs for total coliforms and fecal 

coliforms. EPA is proposing to include in the RTCR an MCL for E. coli because approved 

analytical methods continue to be available to measure the presence of E. coli in water samples, 

i.e., the presence of E. coli is technologically feasible to ascertain. Violation of the proposed 

MCL for E. coli signifies fecal contamination occurrence and a possible high risk of exposure to 
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pathogens. EPA is proposing to eliminate the MCLs for total coliforms and fecal coliforms 

because under the proposal there is no longer an MCLG for either total coliforms or fecal 

coliforms, for the reasons explained earlier. The proposed MCL for E. coli is consistent with the 

recommendation made by the advisory committee in the AIP. 

iii. Coliform treatment technique. The 1996 SDWA amendments authorize EPA to 

promulgate a treatment technique in lieu of an MCL if EPA determines that “it is not 

economically or technologically feasible to ascertain the level of the contaminant” (SDWA 

1412(b)(7)(A)). While it is technologically feasible to ascertain levels of E. coli (i.e., analytical 

methods continue to be available to measure the presence of E. coli in water samples), because of 

the intermittent nature of fecal contamination, it is not economically feasible to ascertain the 

level of E. coli occurrence below which the water may be deemed safe. This is because it is not 

economically feasible to monitor with sufficient frequency to ensure such safety. Therefore, 

EPA is proposing a coliform treatment technique for protection against potential fecal 

contamination to address this concern. 

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

potential pathway of fecal contamination into the distribution system. 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(s) exist(s) and, if found, to correct the defect(s). In addition, 

under the proposed treatment technique requirements, a PWS that incurs an E. coli MCL 

violation must conduct a Level 2 assessment and take remedial action if any sanitary defects are 

found. See section III.A.5 of this preamble for a full discussion of conditions that trigger and 

define Level 1 and Level 2 assessments. 
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The treatment technique requirements as proposed enhance public health protection beyond 

the E. coli MCL for the following reasons: 

• The assessment and corrective action provisions of the treatment technique when the MCL 

for E. coli is exceeded requires PWSs to investigate the potential causes of the fecal 

contamination and requires timely remedial action if any sanitary defects are found. Under 

the current TCR, there are no requirements for investigation and corrective action after an 

MCL exceedance. Without such a find-and-fix provision, the pathway for contamination 

would not be eliminated and sampling alone may not be adequate to identify intermittent 

sources of fecal contamination. The assessment and corrective action provisions of the 

proposed rule increase the likelihood of finding and correcting the sanitary defect and 

minimize the chance of recurrence of fecal contamination in the future. 

• Using total coliforms in addition to E. coli as an indicator to prompt assessment and 

corrective action increases the sensitivity for identifying potential pathways for 

contamination. The presence of total coliforms indicates the potential existence of a pathway 

through which fecal contamination could follow. Analyses from EPA’s 2005 Six-Year 

Review 2 data (USEPA 2006b) (see section VI.B of this preamble for details on the Six-Year 

Review 2 data) and from the proposed RTCR Economic Analysis (EA) occurrence modeling 

show that total coliform presence in drinking water is approximately 20 to 40 times higher 

than E. coli occurrence in drinking water (see chapter 4 of the Proposed RTCR EA (USEPA 

2009a)). Similarly, under the current TCR, non-acute MCL (also referred to as monthly 

MCL) violations (informed by total coliform occurrence) occur roughly 10 times more often 

than acute MCL violations (informed by total coliform and E. coli occurrence, essentially 

equivalent to the occurrence that triggers an E. coli MCL violation under this proposed rule). 
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Thus, including monitoring of total coliforms, as well as E. coli, as part of a treatment 

technique to indicate when systems must find and fix any sanitary defects, substantially 

increases the likelihood of identifying such defects. 

• The proposed treatment technique was supported by the advisory committee and is consistent 

with the recommendations in the AIP. See AIP, pages 6-7. 

c. Request for comment. EPA requests comment on its proposal to eliminate the MCLG 

and MCL provisions for total coliforms and fecal coliforms and to include an MCLG and MCL 

for E. coli and coliform treatment technique provisions based on monitoring for total coliforms 

and E. coli. EPA also requests comment on its proposed definition of the E. coli MCL. 

3. Monitoring 

a. Provisions. As with the current TCR, the proposed 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. Under the proposed RTCR, all PWSs are still required to take repeat 

samples within 24 hours of learning of any routine monitoring sample that is total coliformpositive. PWSs must comply with the repeat monitoring requirements and E. coli analytical 

requirement, discussed in detail in section III.A.4 of this preamble. All samples taken for 

proposed RTCR compliance (routine and repeat) may occur at a customer’s premises, dedicated 

sampling station, or other designated compliance sampling location. 

 Under the proposed RTCR, system sample siting plans must include routine and repeat 

sample sites and any sampling points necessary to meet the Ground Water Rule (GWR) 

requirements. The sample siting plan is subject to State review and revision. The PWS may 

propose repeat monitoring locations that are expected to be representative of a pathway for 

contamination into the distribution system (for example, near a storage tank). Instead of 
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identifying set repeat sampling locations (i.e., within five service connections upstream and 

downstream of the original sampling location that tested total coliform-positive), systems may 

elect to specify 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. Upon State review, 

the PWS 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 modify the SOP as 

needed. To address access issues, small systems must specify in their sampling plans where the 

two additional samples will be taken. 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 problems. 

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

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

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

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

distribution system (see sections III.A.3 and III.A.5 of this preamble). 

 EPA is not proposing to make substantive changes to the current TCR requirements for (1) 

special purpose samples, and (2) invalidation of total coliform samples. EPA is proposing a 

minor modification to the provision for special purpose samples by changing “total coliform 

MCL” to “coliform treatment technique trigger.” 

 The following are the proposed monitoring requirements for different categories of 

systems. 

i. Ground water NCWSs serving ≤ 1,000 people. (a). Routine monitoring. The proposed 

RTCR requires ground water NCWS serving 1,000 or fewer people to routinely monitor each 
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quarter for total coliforms and E. coli. Seasonal systems under this category must routinely 

monitor every month (seasonal systems are discussed later in this section). 

(b). Transition to the RTCR. The proposed RTCR requires all ground water NCWSs serving 

1,000 or fewer people, including seasonal systems, to continue with their TCR monitoring 

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

increased monitoring discussed later on in this section are triggered on or after the compliance 

date or unless otherwise directed by the State, including through the special monitoring 

evaluation conducted under a sanitary survey. 

This rule proposes that after the compliance date of the final RTCR, during each sanitary 

survey the State (which would be either EPA or a State that has received primacy for this rule) 

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 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 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 site-specific 

considerations (such as during periods of highest demand or highest vulnerability to 

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

Systems on annual monitoring, including seasonal systems, must have an initial annual site 

visit by the State within one year of the compliance date (or an annual voluntary Level 2 
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assessment by a party approved by the State) and an annual site visit each year thereafter to 

remain on annual monitoring. 

(c). 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 most recent sanitary survey shows the system is free of sanitary defects, has a protected 

water source and meets approved construction standards; 

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

violations under the current TCR and/or proposed RTCR, no Level 1 or Level 2 trigger 

exceedances or treatment technique violations under the proposed RTCR) for a minimum of 

12 months. (For a more detailed discussion on Level 1 and Level 2 triggers, see section 

III.A.5 of this preamble); and 

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

monitoring, and recurring annually 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. 

(d). Increased monitoring. Ground water NCWS serving 1,000 or fewer people on quarterly 

or annual monitoring that experience any of the following events must begin monthly monitoring 

the month following the event: 
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• 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 monitoring violations in a rolling 12-month 

period or system on annual monitoring has one monitoring violation. 

The system must continue monthly monitoring until the requirements in this section for returning 

to quarterly or annual monitoring are met. 

(e). Requirements for returning to quarterly monitoring. To be eligible to return 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 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. 

(f). Requirements for returning to reduced annual monitoring. To be eligible to return to 

reduced annual monitoring after being placed on increased monitoring, the system must meet the 

criteria to return to routine quarterly monitoring plus the following criteria: 
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• 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 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; 

− Continuous disinfection entering the distribution system and a residual in the distribution 

system in accordance with criteria specified by the State; and 

− 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 as approved by the State. 

(g). Seasonal systems. The proposed rule requires all seasonal systems to demonstrate 

completion of a State-approved start-up procedure on and after the compliance date of the final 

RTCR. Seasonal systems may continue with their TCR monitoring frequency after the 

compliance date of the final RTCR unless or until any of the conditions for increased monitoring 

discussed previously are triggered on or after the compliance date or as directed by the State. 

Under the proposed RTCR, seasonal systems are required to take routine samples monthly. 

To be eligible for reduced monitoring after the compliance date, seasonal systems must meet 

the following criteria: 
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• 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 

• To be eligible for reduced quarterly monitoring, the system must also meet all the reduced 

monitoring criteria discussed in section III.A.3.a.i.(e) of this preamble, Requirements for 

returning to quarterly monitoring. 

• To be eligible for reduced annual monitoring, the system must also meet all the reduced 

monitoring criteria discussed in section III.A.3.a.i.(f) of this preamble, Requirements for 

returning to reduced annual monitoring. 

(h). 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 current 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. In this 

proposal, consistent with the current 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 
Document initiating EO 12866 review 

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employee of the system to perform this site visit, even if the employee is an agent approved 

by the State to perform sanitary surveys. 

• 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. 

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. 

ii. Ground water CWSs serving ≤ 1,000 people. (a). Routine monitoring. The proposed 

RTCR requires ground water CWSs serving 1,000 or fewer people to routinely monitor each 

month for total coliforms and E. coli. 
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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 

(b). Transition to the RTCR. All ground water CWSs serving 1,000 or fewer people 

continue with their current 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 

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.

(c). 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 quarterly reduced monitoring, ground water CWSs serving 1,000 or fewer 

people on monthly monitoring after the compliance date must be in compliance with Statecertified operator provisions and meet each of the following criteria: 

• The most recent sanitary survey shows the system is free of sanitary defects (or has an 

approved plan and schedule to correct them), has a protected water source, and meets 

approved construction standards; 
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• The system must have a clean compliance history (no MCL violations or monitoring 

violations under the current TCR and/or proposed RTCR, no Level 1 or Level 2 trigger 

exceedances or treatment technique violations under the proposed RTCR) for a minimum of 

12 months; and 

• The system must meet at least one of the following criteria: 

− An annual site visit by the State or a voluntary 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), or 

− A cross connection control program, as approved by the State, or 

− The system must maintain continuous disinfection entering the distribution system and a 

residual in the distribution system in accordance with criteria specified by the State, or 

− The system must maintain 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); or 

− Other equivalent enhancements to water systems as approved by the State.

(d). Return to routine monitoring requirements. When a system on quarterly monitoring 

experiences any of the following events the system must begin monthly monitoring: 

• 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); or 

• System has two routine monitoring violations in a rolling 12-month period. 
Document initiating EO 12866 review 

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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.

(e). Additional routine monitoring. All systems 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). 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. The current TCR additional routine monitoring 

requirements consist of taking a total of five samples the month following a total coliformpositive sample for systems that take four or fewer samples per month. In this proposal, 

consistent with the current 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. 

• 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, 
Document initiating EO 12866 review 

39 

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. 

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 

the coliform treatment technique requirements. 

iii. Subpart H systems serving ≤ 1,000 people. The monitoring requirements for subpart H 

systems (PWSs supplied by surface water source or ground water source under the direct 

influence of surface water (GWUDI)) serving 1,000 or fewer people remain the same as under 

the current rule (see §141.856). These systems are not eligible for reduced monitoring. In 

addition, the proposed 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. 

iv. PWSs serving > 1,000 people. The monitoring requirements for PWSs serving more than 

1,000 people remain the same as under the current TCR (see §141.857), with the exception of the 

applicable revisions to the repeat sampling locations provided in §141.858 and additional routine 

monitoring provisions. Systems on monthly monitoring are not required to take additional 

routine samples the month following a total coliform-positive sample. These systems are not 

eligible for reduced monitoring. In addition, the proposed rule requires all seasonal systems, on 
Document initiating EO 12866 review 

40 

and after the compliance date of the final RTCR, to demonstrate completion of a State-approved 

start-up procedure. 

b. EPA’s rationale. i. Sampling sites and monitoring plans. Consistent with current 

practice, the proposed RTCR requires systems to develop a sample siting plan that is 

representative of the water throughout the distribution system. EPA is proposing to maintain the 

provision from the current TCR that indicates that sample siting plans are subject to State review 

and revision. 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 including a periodic review. The advisory committee 

also recommended that specific elements be included in the sampling plans such as the routine 

and repeat sample sites and sampling locations necessary to meet the requirements of the GWR. 

Alternative repeat monitoring locations (e.g., at storage tanks and entry points to the distribution 

system) are subject to State approval. The system must demonstrate to the State’s satisfaction 

that these alternative monitoring locations are representative of the water quality in the 

distribution system. 

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. 

EPA is proposing to allow the use of dedicated sampling locations for the following reasons: 
Document initiating EO 12866 review 

41 

• To reduce potential contamination of the taps. Utilities will have more control to prevent 

contamination of the 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 houses. 

• To improve sampling representation of the distribution system. Allowing dedicated sample 

taps in areas where systems have not been able to gain access will facilitate better sampling 

representation of the distribution system. 

ii. Ground water PWSs serving ≤ 1,000 people. (a). Routine monitoring. The advisory 

committee recommended that ground water NCWSs serving 1,000 or fewer people remain under 

a routine quarterly monitoring as provided in the current TCR. They believed that in conjunction 

with the assessment and corrective action requirements, public health protection would be 

maintained or improved without increasing sampling costs over current TCR requirements. The 

advisory committee also recognized that current sampling costs are not insignificant for small 

systems, and wanted to recognize the good performance of systems by allowing them to be able 

to continue to qualify for reduced monitoring, but under the more specific and rigorous criteria 

described previously. To continue to provide adequate health 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 monthly monitoring. This approach 

leverages the limited resources of these small ground water NCWSs and of States, so that 

systems with minimal problems can minimize their costs and States can focus their resources on 

systems needing the greatest attention, such as systems with problems or vulnerabilities. 
Document initiating EO 12866 review 

42 

The advisory committee thought it best to continue with existing routine monthly 

monitoring requirements for ground water CWSs serving 1,000 or fewer people in order to 

maintain the current levels of effort to identify potential problems. Since sanitary surveys are 

required under the GWR and these surveys provide substantial diagnostic value and corrective 

action response for problems identified, specifying higher routine monitoring frequency for these 

systems was not deemed necessary. These systems may also qualify for reduced monitoring if 

they meet certain criteria. 

(b). Transition to the RTCR. The advisory committee was concerned about the ability of the 

States and systems to adopt the new regulations and to make all the determinations that may be 

necessary to determine the appropriate monitoring frequency within three years of rule 

promulgation. Requiring significant changes in monitoring frequencies in a short period (i.e., 

without a transition period) could overwhelm State resources. The advisory committee 

recommended phasing in the requirements and using the sanitary survey process to facilitate a 

successful transition and implementation. The advisory committee, therefore, recommended that 

these systems continue with their current monitoring frequency during a transition period and 

that the State review the monitoring frequency to determine whether it is appropriate during each 

sanitary survey (USEPA 2008c, AIP p.9). This gives the systems the opportunity to address 

operation and maintenance issues to maintain existing monitoring frequency or qualify for 

reduced monitoring. Systems currently on reduced monitoring could stay on reduced monitoring 

during the transition period and stay on reduced monitoring after that time if they meet certain 

criteria. 

(c). Reduced monitoring. The reduced monitoring requirements are intended to recognize 

that well-operated systems may be less vulnerable to contamination. Therefore, certain 
Document initiating EO 12866 review 

43 

conditions are specified under which reduced monitoring could be allowed. These include a 

clean compliance history for a minimum of 12 months, and an annual visit from the State for 

systems taking one sample per year and correction of all identified sanitary defects. Ground 

water NCWSs serving 1,000 or fewer people, with a routine quarterly monitoring frequency, 

could qualify for reduced annual monitoring, while ground water CWSs serving 1,000 or fewer 

people, with a routine monthly monitoring frequency, could qualify for reduced quarterly 

monitoring. 

For NCWSs on annual monitoring, the advisory committee believed that requiring a system 

to have an annual site visit or a Level 2 assessment provides at least an equivalent level of 

diagnosis of problems and vulnerabilities that might exist as compared to quarterly monitoring 

without an annual site visit. Several States have elected to conduct annual site visits while also 

doing annual monitoring for some NCWSs. 

(d). Increased monitoring requirements for NCWSs. The advisory committee wanted to 

recognize that if certain vulnerabilities are identified in a system, the system should be required 

to conduct more frequent monitoring to identify and correct its problems and better protect 

public health. Other than sanitary surveys or other site visits, monitoring is the primary means to 

identify pathways for potential contamination. If the system is deemed more vulnerable to such 

pathways, as indicated by the increased monitoring criteria, it must conduct more monitoring. 

(e). Requirements for returning to routine monitoring and reduced monitoring. The 

advisory committee believed that systems that address or correct vulnerabilities as indicated by a 

clean compliance history should be allowed to return to routine monitoring, and subsequently to 

reduced monitoring (for NCWS). This provision allows for reduced monitoring costs. 
Document initiating EO 12866 review 

44 

(f). Seasonal systems. The advisory committee recognized that seasonal systems have 

unique characteristics that make them more susceptible to contamination. These systems do not 

maintain pressure while not in operation, which can result in the intrusion of contaminants. 

During the time when a seasonal system is not in operation, septic tank drain fields or other 

pollution sources may accumulate that could affect the conditions or quality of the source water 

(especially for intermittent contaminants) that infrequent monitoring may not be able to capture. 

If monitoring is done only at the start-up, there may not be enough time for the system to reach 

equilibrium (i.e., there might not be enough time to recognize if microorganisms from a septic 

tank moved to the wellhead in seasonally operated systems). Therefore, the proposed rule 

requires seasonal systems to monitor routinely at a monthly frequency. Seasonal systems can 

qualify for reduced monitoring if they meet certain criteria. For a seasonal system to be allowed 

to monitor at a reduced frequency, the proposed rule requires the system to have an approved 

sample siting plan that designates the time period for monitoring and takes into consideration 

site-specific conditions. A system on a reduced monitoring schedule (less than monthly) must 

collect samples when there is the greatest chance that contamination could be identified and, due 

to the variability in water demands, when systems could be most challenged. 

(g). Additional routine monitoring. EPA is proposing to retain the requirement of taking 

additional routine samples the month following a total coliform-positive sample for systems on 

quarterly or annual monitoring. The advisory committee recognized both the benefits and the 

limitations of additional routine monitoring. Additional routine samples are meant to enhance 

the diagnostic ability and supplement the infrequent routine monitoring of systems on quarterly 

or annual monitoring. Without the provision of additional monitoring, systems on annual or 

quarterly monitoring with a total coliform-positive sample would not take any samples the 
Document initiating EO 12866 review 

45 

following month. The advisory committee believed that additional samples collected the 

following month are appropriate to help recognize the problem if it still persists. 

For systems required to take the additional routine samples the following month (i.e., 

systems on quarterly or annual monitoring), the proposed RTCR changes the requirement from 

taking a total of five routine samples to a requirement of just three routine samples. The 

advisory committee recognized 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 recognizes that a reduction in the number of 

samples taken could also mean a reduction in the number of positive samples found. However, 

the reduction in the number of additional routine samples in conjunction with the new 

assessment and corrective action provisions of the proposed RTCR (discussed in section III.A.5 

of this preamble) leads to a rule that is ultimately more protective of public health (i.e., more E. 

coli MCL violations being prevented) and improvement in water quality (i.e., decrease in the 

total coliform and E. coli-positive hit rates observed as shown by the Proposed RTCR EA 

occurrence modeling results). See chapter 6 of the Proposed RTCR EA (USEPA 2009a) for 

more details. 

For systems taking at least one sample monthly, the advisory committee recommended no 

additional routine samples for these systems for the following reason. Taking no additional 

routine samples the following month substantially reduces monitoring costs. The assessment and 

corrective action provisions will give systems the ability to identify and prevent the occurrence 

of problems. EA modeling results show that although there is a decrease in the number of E. coli

MCL violations found with the decrease in the number of additional routine samples taken (i.e., 

going from five samples to one during the month following a total coliform-positive), the 
Document initiating EO 12866 review 

46 

assessment and corrective action provisions leads to more E. coli MCL violations being 

prevented compared to the current TCR (see Exhibit 6-7 of the Proposed RTCR EA (USEPA 

2009a) for more details). 

In addition, whenever a total coliform-positive occurs during routine sampling, there is also 

a requirement to conduct repeat sampling to determine the extent of contamination or if potential 

pathways to contamination persist. For small systems serving 1,000 or fewer people on monthly 

monitoring, if a repeat sample is total coliform-positive, at least a Level 1 assessment will be 

triggered. If a sanitary defect(s) is (are) found, the system is required to correct the sanitary 

defect(s). 

For systems on monthly monitoring, the assessment and corrective action provisions and 

the repeat sampling provisions mitigate the need for additional routine sampling for the 

following month. 

iii. Subpart H systems serving ≤ 1,000 people. EPA is not proposing to change the routine 

monitoring requirements for systems using surface water or GWUDI serving 1,000 or fewer 

people, which include not allowing reduced monitoring for these systems. Since systems using 

surface water or ground water under the influence of surface water tend to have much higher 

levels of contaminants in their source water, and in general have more complex operations than 

ground water systems, it is appropriate to allow reduced routine monitoring for ground water 

systems but not for subpart H systems. The advisory committee recommended that no reduced 

routine monitoring provisions be allowed for subpart H systems serving 1,000 or fewer people. 

iv. Public water systems serving > 1,000 people. EPA is proposing to eliminate the 

additional routine samples the month following a total coliform-positive sample for PWSs 

serving between 1,000 and 4,100 people for the same reasons discussed previously for small 
Document initiating EO 12866 review 

47 

ground water systems monitoring monthly. PWSs serving more than 1,000 people are currently 

required to routinely monitor monthly (one to four samples per month depending on size) and 

continue to do so under the proposed RTCR. 

c. Request for comment. EPA requests comment on the proposed monitoring requirements 

for PWSs. Specifically, EPA requests comment on the following questions: Are there other 

issues that EPA should consider in its approach to help systems transition to the RTCR? Should 

EPA develop guidance that would help States identify seasonal systems and implement the 

RTCR requirements (e.g., suggestions for start up procedures and identifying vulnerable time 

periods)? EPA also requests comment on whether seasonal systems should be required to 

comply with State-directed shut down procedures (in addition to start-up procedures). 

EPA requests comment on the following additional questions: Should daily measurement of 

chlorine residual count toward the maximum residual disinfectant level (MRDL) monitoring and 

be one of the criteria for reduced monitoring? Should NTNCWSs be required to comply with the 

CWS requirements (as they are in other rules such as DBP rules) since NTNCWSs serve the 

same people over time and include populations that may be at greater risk (e.g., schools, 

hospitals, nursing homes)? Will the reduced, routine, and increased monitoring requirements for 

NCWSs shift the fixed State resources from CWS oversight to NCWS oversight in those States 

with large numbers of NCWSs? If so, what might be done to limit the impact? Should EPA 

develop guidance on how to develop a sample siting plan? Should sample siting plans require 

State approval? 

EPA and the advisory committee did not identify any specific issues regarding consecutive 

systems in the proposed RTCR. EPA requests comment on whether there are such issues and 

how they should be addressed in the RTCR. 
Document initiating EO 12866 review 

48 

4. Repeat samples 

a. Provisions. Under the proposed RTCR, all systems must take at least three repeat 

samples for each routine total coliform-positive sample. This is a change from the current 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. EPA is not changing the 

following provisions: the 24-hour limit within which the system must collect the repeat samples; 

the authority of the State to extend this limit on a case-by-case basis; and the non-waiver by the 

State of the requirement for a system to collect repeat samples. 

In addition to taking repeat samples, systems must test each routine total coliform-positive 

sample for E. coli. They must also test any repeat total coliform-positive sample for E. coli. As 

with the current TCR, 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 at the latest. The proposed rule is not 

changing the provision that a 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. 

As with the current TCR, 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 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. The system may also propose 
Document initiating EO 12866 review 

49 

alternative repeat monitoring locations as discussed in this section. 

Under the proposed rule, ground water systems (GWSs) required to conduct triggered source 

monitoring under the GWR must take ground water source samples in addition to the repeat 

samples. However, 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 repeat monitoring requirements of 

the proposed RTCR and the source water monitoring requirements of the GWR, but only if the 

State approves the use of a single sample to meet both rule requirements (i.e., a dual purpose 

sample) 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 proposed RTCR and must also 

comply with the GWR requirements following a fecal indictor-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 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 repeat sample at the triggered source water monitoring location and has more than 

one repeat sample that is E. coli-positive, then the system would have an E. coli MCL violation 

under the proposed RTCR and a second fecal indicator-positive source sample under the GWR. 

The system would then need to also comply with the treatment technique requirements under 40 

CFR 141.403. 
Document initiating EO 12866 review 

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Under the proposed rule, the system must collect all repeat samples on the same day 

consistent with current TCR requirements. 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 ml. 

The proposed RTCR is not changing the requirement that systems 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 

the system determines that the coliform treatment technique trigger has been exceeded and 

notifies the State. After a trigger (see section III.A.5 of this preamble) is reached, the system is 

not required to conduct more than one additional round of repeat monitoring. 

The proposed RTCR is also not changing the current TCR provision that 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. 

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.A.5 of this preamble for a discussion of the coliform treatment technique triggers). 

b. EPA’s rationale. i. Why EPA is maintaining a provision for repeat sampling. As with 

the current TCR, the proposed RTCR requires systems to take repeat samples after a total 

coliform-positive sample. EPA believes that sampling immediately after an initial positive 
Document initiating EO 12866 review 

51 

sample (i.e., conducting repeat sampling) increases the likelihood of identifying the source 

and/or nature of the possible contamination. Analysis 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 Exhibit III-1). Repeat 

sampling (when total coliform-positive) can indicate a current pathway for potential external 

contamination into the distribution system. 

EPA used the Six-Year Review 2 data to support statistical modeling which produced 

estimates of average occurrence of routine total coliform-positive samples and repeat total 

coliform-positive samples and to characterize how occurrence varies from system to system. 

EPA’s occurrence model assumes that, among similar systems, the positive rate for total 

coliforms in routine samples varies as a beta random variable. EPA used the Six-Year Review 2 

data to estimate the parameters for the distribution of occurrences of routine and repeat total 

coliform-positive samples. 

Exhibit III-1 shows the relative probability of finding a total coliform-positive result from 

routine samples versus from repeat samples for 27 basic subsets of systems. The table combines 

regular routine and additional routine samples since no distinction was available for the Six-Year 

Review 2 data set. The relative probability is defined as the ratio of the probability of getting a 

total coliform-positive result from a repeat sample to the probability of getting a total coliformpositive result from a routine sample. 

Exhibit III-1 Relative Probability of Total Coliform-Positive Samples in Routine Compared 

to Repeat Samples. 
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System type 1 Average 

pRTTC 2

Average 

pRPTC 3

Ratio 

pRPTC / pRTTC

TNCWS undisinfected GW 

<101 4.8% 28% 5.9 

101-1,000 4.8% 25% 5.2 

1,001-4,100 2.5% 17% 6.9 

NTNCWS undisinfected GW 

<101 3.7% 26% 7.0 

101-1,000 2.7% 26% 9.6 

1,001-4,100 2.7% 26% 9.6 

CWS undisinfected GW 

<101 3.1% 19% 6.0 

101-1,000 2.7% 19% 7.1 

1,001-4,100 2.7% 13% 4.9 

TNCWS disinfected GW 

<101 2.3% 14% 6.2 

101-1,000 2.3% 14% 6.2 

1,001-4,100 2.3% 14% 6.2 

NTNCWS disinfected GW 

<101 1.6% 11% 6.7 

101-1,000 1.1% 11% 9.4 

1,001-4,100 1.1% 11% 9.4 

CWS disinfected GW 

<101 1.6% 9.4% 5.9 

101-1,000 1.2% 9.4% 7.6 

1,001-4,100 0.78% 5.2% 6.7 

TNCWS SW 

<101 2.3% 14% 6.2 

101-1,000 2.3% 14% 6.2 

1,001-4,100 2.3% 14% 6.2 

NTNCWS SW 

<101 1.6% 11% 6.7 

101-1,000 1.1% 11% 9.4 

1,001-4,100 1.1% 11% 9.4 

CWS SW 

<101 1.5% 6.5% 4.3 

101-1,000 0.95% 6.5% 6.8 

1,001-4,100 0.59% 3.4% 5.8 

1

 The following acronyms are used: (1) TNCWS Transient Non-Community Water System; (2) 

NTNCWS Non-Transient Non-Community Water System; (3) CWS Community Water System; 

(4) GW Ground Water; (5) SW Surface Water 

2

 Average probability of a total coliform-positive from a routine total coliform sample 

3

 Average probability of a total coliform-positive from a repeat total coliform sample 
Document initiating EO 12866 review 

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Exhibit III-1 shows that for any type and size of system, regardless of source water and 

disinfection practice, repeat total coliform samples (triggered by positive routine samples) are 

much more likely to be positive than are routine samples. For small (serving 100 or fewer 

people) CWSs that provide undisinfected ground water, the average repeat total coliformpositive rate (19 percent) is about six times as great as the average routine total coliform-positive 

rate (3.1 percent) for these systems. The ratio of repeat to routine total coliform-positive rates is 

greater for some sets of systems and smaller for others, but a ratio of at least six to one is 

common. Similar ratios of repeat to routine monitoring total coliform-positive rates were found 

for disinfected systems (ground water and surface water systems). 

Exhibit III-2 shows maximum likelihood distributions for the positive rates in routine and 

repeat samples of small TNCWSs (serving 100 people or fewer) serving undisinfected ground 

water. The vertical axis shows cumulative probability, which is the fraction of systems having at 

most the corresponding horizontal axis value. Corresponding to 0.5 on the vertical axis is the 

median probability of a total coliform-positive. For example, for half of the systems, the 

probability of getting a total coliform-positive is 1.3 percent (i.e., 0.013 probability of total 

coliform-positive on horizontal axis) for routine samples. This is the median probability of total 

coliform-positive in routine samples. For repeat samples, the median probability of a positive is 

17.5 percent (i.e., 0.175 probability of total coliform-positive on horizontal axis), which is about 

13 times greater than that of the routine samples. 

Exhibit III-2 Maximum Likelihood Distribution for TNCWS Serving Undisinfected GW to 

<101 People 
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0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

Routine Samples

Repeat Samples

Median(Routines) = 1.3%

Median(Repeats) = 17.5%

Probability of Total Coliform Positive

Cumulative Probability

ii. Frequency of repeat samples. The advisory committee recommended that the current 

TCR requirement for systems serving more than 1,000 people to take three repeat samples 

subsequent to a routine total coliform-positive be retained. The advisory committee 

recommended that systems serving 1,000 or fewer people also be required to take three repeat 

samples rather than the four required under the current TCR. This view is supported by analysis 

of repeat sample records from the Six-Year Review 2 data. 

Repeat sampling helps utility operators to better understand the extent and duration of 

potential pathways of contamination into the distribution system. The Six-Year Review 2 data 

show that the average percentage of samples that are positive among repeat samples is much 

higher than that of routine samples, demonstrating that when operators are required to take a 
Document initiating EO 12866 review 

55 

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 words, the high repeat 

total coliform-positive rate indicates the persistence of total coliforms at such locations in the 

distribution system. 

Further analysis of the data shows that for all PWSs serving 1,000 or fewer people, two or 

more of the repeat samples are positive in 75 percent of those instances in which there are any 

positive repeat samples, as shown in Exhibit III-3. For those 75 percent of instances, reducing 

the number of repeat samples from four to three would have no effect on the number of systems 

that would be triggered to conduct an assessment of the system under the proposed RTCR. In 

these cases, at least one of the remaining repeat samples would still be total coliform-positive, 

and only one positive repeat sample is required to trigger an assessment. 

The data show that one repeat sample is positive in 25 percent of the instances in which any 

of the four repeat samples is positive. For these instances, EPA estimates that if only three 

repeat samples had been taken instead of four, three out of four (or 75 percent) of these positive 

samples would still have been encountered. 

Exhibit III-3 Percentage of instances with 1 or >1 positive repeat samples among 

those instances in which ≥1 repeat samples is positive 

Number of Positive Repeat Samples 

System Category 1 > 1 

Undisinfected GWSs Serving 

≤1000 23% 77% 

All PWSs Serving ≤1000 25% 75% 

Note: Analysis of Six-Year Review 2 data repeat sample records associated 

with months in which ≥ 50% of expected routine samples were taken (50% 

criterion). The total number of instances of positive repeat samples for 

undisinfected GWSs ≤ 1000 is 2953, while all PWSs ≤ 1000 have 3537 

positive repeat samples. 

Source: Proposed RTCR EA Appendix H (USEPA 2009a) 
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When both of the two situations in which at least one repeat sample is positive (either one 

positive repeat sample or more than one positive repeat sample) are considered together, it is 

possible to estimate the overall effect of reducing the number of repeats from four to three, as 

presented in Exhibit III-4. The estimates in the table indicate 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. 

Exhibit III-4 Estimated Effects of Reducing Number of Required Repeat Samples for 

PWSs Serving ≤1000 from 4 to 3 

 

Percentage of 

events1 with 

exactly 1 total 

coliform-positive 

(TC+) repeat 

sample 

Estimated 

percentage of 

events that 

would still have 

1 TC+ if 1 out of 

4 repeat samples 

were not taken 

Percentage of 

events1 with >1 

TC+ repeat 

sample 

Estimated overall 

percentage of 

events that 

would still have 

≥1 TC+ repeat 

sample if 1 out 

of 4 repeat 

samples were not 

taken 

 A B = A*0.75 C D = B+C 

Undisinfected 

GWSs Serving 

≤1000 23% 18% 77% 94.2%

All PWSs 

Serving ≤1000 25% 19% 75% 93.8%

1

Based on analysis of repeat sample records associated with months in which ≥ 50% of expected 

routine samples were taken (50% criterion). The total number of events for undisinfected GWSs 

≤ 1000 is 2953, while all PWSs ≤ 1000 have 3537 events. 

Source: Proposed RTCR EA Appendix H (USEPA 2009a) 

Although dropping the required number of repeat samples from four to three means that 

some fraction of triggers may be missed, the other provisions of the proposed RTCR compensate 
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for that change and, taken as a whole, the provisions of the proposed 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 proposed 

RTCR are triggered to conduct a Level 1 assessment. This permits an increase in public health 

protection over the current TCR because PWSs are required to assess their systems when 

monitoring results show that the PWS may be vulnerable to contamination (indicated by a 

routine total coliform-positive sample). Moreover, because of the substantial cost of this 

potential consequence, systems would be more likely to take all of their required repeat samples 

in the first place. 

It is important to point out that the majority of systems in this category are ground water 

systems treating to less than 4-log inactivation for viruses (see Exhibit 4.1 of the Proposed RTCR 

EA (USEPA 2009a)). Because of the triggered source monitoring provision under the GWR, 

these systems are required to collect a fecal indicator sample from the source water following a 

total coliform-positive sample in the distribution system in addition to the repeat samples. Under 

the existing GWR and TCR, systems taking four repeat samples are permitted to take the fourth 

repeat sample at the source water if they measure for E. coli as the fecal indicator and if they 

have State approval. Under the proposed RTCR, systems would continue to take this source 

water sample to comply with the GWR in addition to three repeat samples in the distribution 

system to comply with the TCR. A positive sample at the source that is not also considered a 

repeat sample would not trigger an assessment under the proposed RTCR, but it would provide 

diagnostic value to the system in addition to triggering additional requirements under the GWR 

(i.e., corrective action or five additional source water fecal indicator samples). 
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With State approval, ground water systems serving 1,000 or fewer people may use the 

sample taken at the location required for triggered source monitoring to also meet the repeat 

monitoring requirements of the proposed RTCR. In this case, the State must also approve the 

use of E. coli as the fecal indicator under the GWR, and the system would comply with both 

GWR and the proposed RTCR when a total coliform-positive or E. coli-positive sample occurs. 

The advisory committee recommended this flexibility to reduce the burden on small groundwater 

systems that in most cases will have a very limited distribution system and only one source, 

consistent with the GWR. 

iii. Location of repeat samples. The advisory committee believed that requiring repeat 

samples to be taken within five service connections up and downstream of the original total 

coliform-positive location can be difficult for systems to implement within the required 24 hours 

for a repeat sample because of issues such as access to the site. Therefore, the advisory 

committee recommended that systems be allowed to develop standard operating procedures as 

part of their sample siting plan to identify alternative monitoring sites and facilitate the 

identification of the source and extent of any problem. 

The advisory committee also recommended that ground water systems have the flexibility to 

propose repeat sampling locations that differentiate potential source water and distribution 

system contamination (e.g., by sampling at entry points to the distribution system). See section 

III.A.3 of this preamble for additional discussion on this topic.

c. Request for comment. EPA requests comment on the foregoing proposed repeat sampling 

requirements. Specifically, EPA requests comment on the proposal to allow 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 proposed RTCR. 
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5. Treatment technique requirements 

a. Provisions. i. Coliform treatment technique triggers. The non-acute MCL violation for 

total coliforms under the current TCR is effectively replaced by a coliform treatment technique 

involving monitoring for total coliforms under the proposed RTCR. Under the proposed 

treatment technique framework, the presence of total coliforms is used as an indicator of the 

potential pathway of contamination into the distribution system. As discussed in section III.A.2 

of this preamble, the proposed RTCR eliminates the associated MCLG and MCL for total 

coliforms. The proposed revision specifies two levels of treatment technique triggers, Level 1 

and Level 2, and their corresponding levels of response. Whether systems are required to 

conduct either a Level 1 or Level 2 assessment is based on the degree of potential pathway for 

contamination. The proposed rule further lays out an additional trigger for a Level 1 assessment 

and defines Level 2 triggers that require a more in-depth examination of the system and its 

monitoring and operational practices. 

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. 

Level 2 treatment technique triggers 
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• The PWS has an E. coli MCL violation (see section III.A.6 of this preamble for 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 first 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. 

• For PWSs with approved reduced annual monitoring, a Level 1 treatment technique trigger in 

two consecutive years. 

ii. Assessment. EPA is proposing an assessment process in the RTCR to strengthen public 

health protection. Under the current TCR, a system is not required to perform an assessment 

following a monthly/ non-acute MCL violation or an acute MCL violation. In contrast, the 

proposed RTCR requires systems to conduct assessments following the triggers specified above. 

EPA is proposing 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: 

• Inadequacies in sample sites, sampling protocol, and sample processing, 

• 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, 
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• Source and treatment considerations that bear on distributed water quality, where 

appropriate, and 

• Existing water quality monitoring data. 

EPA expects that States will tailor specific assessment elements to the size and type of the 

system and that each public water system in turn will tailor its assessment activities based on the 

characteristics of its distribution system. 

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 above. Under the proposed rule, this self-assessment shall 

consist of a basic examination of the source water, treatment, distribution system and relevant 

operational practices. The PWS might 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 check the conditions of the following elements: sample sites, 

distribution system, storage tanks, source water, etc. 

The PWS must complete the Level 1 assessment as soon as practical after notification of its 

monitoring results or failure to take repeat samples. The PWS must submit the completed 

assessment form to the State for review within 30 days after determination that the PWS has 

exceeded the trigger. Failure to submit the completed assessment form within 30 days is a 

reporting violation. If the State determines that the assessment is insufficient, the State will 

consult with the PWS. If necessary 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. 
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In the completed assessment form, the PWS must identify assessments conducted, sanitary 

defects detected, corrective actions completed, and a timetable for any corrective actions not 

already completed. If no sanitary defects are found in an assessment, the assessor may note that 

no sanitary defects were identified. Upon completion and submission of the assessment form by 

the PWS to the State, the State shall determine if the system has identified the likely cause(s) for 

the Level 1 treatment technique trigger and establish whether the system has corrected the 

problem(s). 

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. 

A Level 2 assessment is a more comprehensive examination of the system, its monitoring 

and operational practices than the Level 1 assessment. The level of effort and resources 

committed to undertaking a Level 2 assessment will be commensurate with the more 

comprehensive investigation and review of available information, and engage additional parties 

and expertise relative to the Level 1 assessment (see Appendix Y of the AIP) (USEPA 2008c). 

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 complete the Level 2 assessment as soon as practical after notification that 

the PWS has exceeded a Level 2 treatment technique trigger. The PWS must submit the 

completed assessment form to the State for review within 30 days after determination that the 
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PWS has exceeded the trigger. Failure to submit the completed assessment form after the PWS 

properly conducts the assessment is a reporting violation. The State may direct expedited action 

or additional actions such as in the case of an E. coli MCL violation. If the State determines that 

the assessment is insufficient, the State will consult with the PWS. If necessary 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. 

In the completed assessment form, the PWS must identify assessments conducted, sanitary 

defects detected, corrective actions completed, and a timetable for any corrective actions not 

already completed. If no sanitary defects are found in an assessment, the assessor may note that 

no sanitary defects were identified. Upon completion and submission of the assessment form by 

the PWS to the State, the State shall determine if the system has identified the likely cause(s) for 

the Level 2 treatment technique trigger and, if so, establish that the system has corrected the 

problem(s). 

iii. Corrective action. The current TCR does not require systems that have MCL violations 

to perform corrective actions. Under this proposal, EPA is requiring PWSs to correct sanitary 

defects found through either a Level 1 or Level 2 assessment. Ideally, systems will be able to 

correct any sanitary defects found in the assessment within 30 days and report that correction on 

the assessment form. When the correction of sanitary defects is not completed by the time the 

PWS submits the completed assessment form to the State, the PWS must complete the corrective 

action(s) on a schedule determined by the State. This schedule may be developed in consultation 

with the PWS. The schedule must include when the corrective action will be completed and any 

necessary milestones and temporary public health protection measures. The PWS must notify 

the State when each scheduled corrective action is completed. 
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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. 

E. coli detection in the distribution system indicates a public health hazard and can result in 

an E. coli MCL violation. Under the proposed rule, when an E. coli MCL violation has occurred, 

the system must complete a Level 2 assessment and corrective action must be implemented as 

soon as practical. The Agency encourages systems to promptly find the source of E. coli and fix 

the problem before the completed assessment form is due to the State. 

b. EPA’s rationale. i. Coliform treatment technique. The advisory committee indicated 

that the conditions leading to a monthly/non-acute MCL under the current TCR should trigger an 

assessment under the RTCR for several reasons. First, the advisory committee recognized that 

presence of total coliform indicates that potential presence of a pathway for contamination from 

external sources such as source water or through a loss of distribution system integrity. The 

change to a coliform treatment technique construct that uses total coliforms as an indicator of 

distribution system integrity places the emphasis on systems to take more preventive actions to 

address problems. These actions would better protect public health than the additional 

monitoring with no corrective action that is required under the current TCR. To address the high 

and constant number of PWSs with violations over the years under the current TCR, the 

proposed changes would be more protective by requiring systems to correct deficiencies 

associated with the non-acute MCL (see Exhibit VI.1 in section VI.C.1 of this preamble). 

Second, the advisory committee indicated that the public notice associated with non-acute 
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violations is confusing because the presence of total coliforms is not necessarily an indication of 

a potential public health threat; however, it is an indicator of a potential pathway for fecal 

contamination to enter into the distribution system. Under the treatment technique requirement, 

the presence of total coliforms (at the level equivalent to a non-acute violation) indicates a need 

to assess whether a problem exists. When a system fails to conduct the assessment, the system 

will then incur a violation and be required to issue public notification. Third, the occurrence of 

total coliforms in the context of the coliform treatment technique requirement continues to 

inform and further the original objectives of the TCR: to evaluate the effectiveness of treatment, 

determine the integrity of the distribution system, and signal the possible presence of fecal 

contamination. Finally, total coliform presence indicates the potential presence of a pathway for 

contaminants from external sources such as source water or through a loss of distribution system 

integrity. 

ii. Assessment. The proposed rule requires assessments to ensure that specific action is 

taken to identify whether potential pathways of contamination into the distribution system exist. 

The advisory committee indicated that assessments are significant actions that protect public 

health. Under the current rule, when a system has a non-acute MCL violation and if any 

subsequent sampling did not detect total coliform, the problem may persist due to the 

intermittent nature of total coliform and remain unaddressed. However, the absence of total 

coliform-positive samples subsequent to an initial positive finding is not a reliable indicator that 

a contamination pathway no longer exists. In contrast, the proposed revisions would ensure that 

systems examine and assess the cause of the total coliform occurrence (that is equivalent to the 

current non-acute MCL level) and take any corrective action if necessary. 
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Under the proposed rule, the system will also be required to conduct an assessment if it fails 

to conduct repeat monitoring following an initial total coliform-positive sample result. As 

discussed in section III.A.4 of this preamble, repeat monitoring is critical in identifying the 

extent, source, and characteristics of fecal contamination in a timely manner. Since the revised 

rule proposes to eliminate additional routine monitoring for systems that monitor at least 

monthly and decrease the number of additional routine monitoring and repeat monitoring 

samples for the smallest systems, the need to conduct repeat monitoring is more crucial than ever 

in providing immediate and useful information needed to protect public health. The cost for 

collecting and analyzing a repeat sample would be considerably less than the cost for 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. 

The proposed rule specifies two different levels of assessments – Level 1 and Level 2 – to 

recognize that a higher level of effort to diagnose a problem applies to situations of greater 

potential of public health concern such as repeated Level 1 triggers or an E. coli MCL violation. 

Level 2 assessments are conducted by a party approved by the State, which may be the PWS 

where it has staff or management with the certification or qualifications as determined by the 

State. The Level 2 assessments may also be conducted by the State or a third party approved by 

the State. 

To make more transparent what the Level 1 and Level 2 assessments entail and to facilitate 

consistent implementation among States, the proposed rule specifies minimum elements for these 

assessments. The advisory committee recommended that the minimum elements identified 

previously in this preamble be included in the Level 1 and Level 2 assessments to identify 

potential flaws in monitoring or specific pathways of contamination. Although the proposed 
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RTCR specifies the same minimum elements for both the Level 1 and Level 2 assessments, the 

Level 2 assessment involves a more in-depth examination of these elements compared to a Level 

1 assessment. Specific examples of how the Level 2 assessments are more in-depth than Level 1 

assessments may be found in Appendix X of the AIP (USEPA 2008c). 

EPA recognizes that not every assessment will identify a sanitary defect or find a reason or 

cause for the presence of total coliforms. If no sanitary defect is identified, the system must 

document that fact in the completed assessment form and provide supporting evidence for this 

conclusion. EPA expects that only systems that adhere to proper procedures and standards set by 

the State are eligible to arrive at this determination, and only after providing sufficient 

supporting evidence. 

The advisory committee recommended that the Level 1 and Level 2 assessments be 

conducted as soon as practical after the PWS receives notice that the system has exceeded the 

treatment technique trigger. The advisory committee also recommended that systems submit the 

completed assessment forms to the State within 30 days after determination that the PWS has 

exceeded the trigger. The rationale for the 30-day interval is to allow sufficient time for problem 

identification and potential remediation of the problem in conjunction with the follow-up 

assessment, in most cases. 

To help States and PWSs conduct assessments, EPA intends to develop a draft assessment 

and corrective action guidance manual and to make it available for public comment prior to 

promulgation of the final rule and to finalize the guidance manual after the rule is finalized. 

iii. Corrective action. The advisory committee recognized that not every assessment will 

identify a sanitary defect. However, the advisory committee recommended that the RTCR 
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require all sanitary defects be corrected by the system in a timely manner. The system, in 

consultation with the State as needed, identifies and determines the specific corrective action. 

Under the proposed rule, the State may allow the PWS additional time to conduct the 

corrective action if needed. EPA recognizes that some systems may not be able to fix sanitary 

defects before submitting the completed assessment form within the 30-day interval due to the 

extent and cost of the corrective action. In such situations, EPA encourages the State and PWS 

to work together to determine the appropriate schedule for corrective actions to be completed. 

The system must comply with the agreed upon schedule and notify the State when each 

scheduled corrective action is completed. 

Either the PWS or the State may request consultation with the other party to determine the 

appropriate actions to be taken. EPA is not requiring this to be a mandatory consultation to 

provide ease of implementation for States. In many cases, consultation may not be necessary 

because the type of corrective action for the sanitary defect will be clear and can be fixed right 

away (for example, replacement of a missing screen). 

c. Request for comment. EPA requests comment on the: (1) proposed change from the nonacute MCL for total coliforms to a coliform treatment technique requirement that uses total 

coliforms as an indicator of a pathway of contamination; (2) proposed requirement for systems to 

conduct an assessment following a trigger condition; (3) proposed levels of assessment required; 

and (4) proposed requirement for systems to correct all sanitary defects found during an 

assessment. In addition, EPA requests comment on how to ensure that a Level 2 assessment is 

more comprehensive than a Level 1 assessment (e.g., should a Level 2 assessment include 

additional elements such as asset management and capacity development?). 

6. Violations 
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a. Provisions. EPA is proposing to modify the definition of the existing MCL violation, 

establish a treatment technique violation, and revise the monitoring and reporting violations. 

EPA is proposing that public notice be required for each type of violation (see section III.A.7 of 

this preamble for detail information on public notification). 

i. E. coli MCL violation. A violation of the E. coli MCL occurs when: 

• a routine sample is total coliform-positive and one of its associated repeat samples is E. colipositive; or 

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

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

for E. coli; or 

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

ii. Coliform treatment technique violation. A coliform treatment technique violation occurs 

when: 

• a system fails to conduct a required assessment within 30 days of notification of the system 

exceeding the trigger (see section III.A.5 of this preamble for conditions under which 

monitoring results trigger a required assessment); or 

• a system fails to correct any sanitary defect found through either a Level 1 or 2 assessment 

within 30 days (see also section III.A.6 of this preamble) or in accordance with State-derived 

schedule. 

There would be no treatment technique violation associated solely with a system exceeding one 

or more action triggers (Level 1 or Level 2 triggers). 
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iii. Monitoring violation. Under the current TCR, a monitoring violation occurs when a 

system fails to comply with the total coliform monitoring requirements, including the sanitary 

survey requirement. Under the proposed RTCR, a monitoring violation occurs when a system 

fails to take every required routine or additional routine sample in a compliance period, or when 

it fails to test for E. coli following a routine sample that is total coliform-positive. 

In addition, if a system on quarterly monitoring has a monitoring violation in two or more 

quarters, or if a system on annual monitoring misses its annual monitoring, it must begin 

monthly monitoring until it meets criteria for less frequent monitoring. See section III.A.3 of 

this preamble for a detailed discussion on monitoring frequency. 

iv. Reporting violation. A reporting violation occurs when a system that properly conducts 

monitoring or an assessment fails to submit a monitoring report or a correctly completed 

assessment form by the required deadline. The PWS is responsible for reporting this information 

to the State regardless of any arrangement with a laboratory. A reporting violation also occurs 

when a system fails to notify the State following an E. coli-positive sample. 

b. EPA’s rationale. To define violations, the advisory committee built upon the principles 

underlying the current TCR violations and current TCR public notification and suggested 

changes to improve public health protection where they saw a specific need. This proposal 

specifies responses to different degrees of potential public health concern. As described in the 

next section on providing information and notification to the public, Tier 1, Tier 2, and Tier 3 

public notices are required following violations corresponding to the severity of each violation 

type. 

i. E. coli MCL violation. An E. coli MCL violation (which includes failure to take all 

required repeat samples following an E. coli-positive sample) creates concern of an immediate 
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potential public health threat. For this reason, an E. coli MCL violation is considered an acute 

violation requiring immediate response by the system. Including an E. coli MCL violation 

condition for systems failing to collect all repeat samples following an initial E. coli-positive 

sample enhances public health protection by preventing a system from incurring only a 

monitoring violation when there is an indication of fecal contamination. As discussed previously 

in section II.D of this preamble, the presence of E. coli indicates a pathway of fecal 

contamination and should be taken seriously. Systems need to follow up with repeat samples to 

characterize the extent and source of such contamination. Failure to take the required repeat 

samples following an initial E. coli-positive sample is not protective of public health and is a 

serious violation. 

ii. Coliform treatment technique violation. A coliform treatment technique violation occurs 

when a potential pathway of contamination in the distribution system is unexplored and/or 

uncorrected. Performing the Level 1 and 2 assessments and taking corrective action are essential 

aspects of compliance with the treatment technique. A system which neglects to perform the 

prescribed assessment or corrective action is in violation of the proposed RTCR’s treatment 

technique requirements. 

iii. Monitoring violation and reporting violation. Monitoring and reporting violations occur 

when a system fails to comply with the routine monitoring requirements or when a system fails 

to submit monitoring reports or completed assessment forms. EPA believes that monitoring 

violations and reporting violations need to be addressed so that a system is held accountable to 

take actions to reduce public health risk, including regular monitoring of water quality. 

c. Request for comment. EPA requests comment on the proposed violation determinations. 

7. Providing notification and information to the public 
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a. Provisions. To correspond to the changes in the proposed revised rule, EPA is proposing 

some modifications to the public notice (PN) requirements contained in 40 CFR part 141 subpart 

Q. Tier 1 PN is required for an E. coli MCL violation. Tier 2 PN is required for a treatment 

technique violation for failure to conduct assessments or corrective actions. Tier 3 PN is 

required for a monitoring violation or a reporting violation. 

In the current TCR, if a system has an acute MCL violation which is based on the presence 

of fecal coliforms or E. coli, or which is based on 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 proposed RTCR, a system is required to publish Tier 1 PN when it has 

exceeded the E. coli MCL violation (see section III.A.6 of this preamble for what constitutes an 

E. coli MCL violation). In addition, the system will continue to be required to notify the State 

after learning of an E. coli-positive sample, as currently is required under the TCR. As 

mentioned earlier in section III.A.2 of this preamble, EPA is proposing to eliminate the MCL for 

fecal coliforms. Under the proposed rule, 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, and to include a reference to the assessments and corrective 

actions in the subpart Y coliform assessment violations. 

In the current TCR, a system is required to publish a Tier 2 PN when the system exceeds the 

non-acute MCL violation, which is based on total coliform presence. Under the proposed rule, a 

system is required to publish a Tier 2 PN if the system violates the coliform treatment technique 

requirements. Also, EPA is proposing to modify the standard health effects language for 

coliform to emphasize the assessment and corrective action requirements of the proposed rule. 
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In the current TCR, a system is required to publish a Tier 3 PN when the system has a 

monitoring and reporting violation. In the proposed rule, the Tier 3 PN requirements are 

changed to incorporate the recommendation in the AIP that monitoring violations be considered 

separately from reporting violations under the proposed RTCR. Both types of violations require 

Tier 3 PN. 

Consumer confidence report (CCR) requirements are also modified. Health effects language 

for the CCR, which is identical to the health effects language required for PN, is updated in the 

same way as described for PN. In addition, the proposed RTCR removes the CCR requirements 

that require 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 corrective actions required and completed, and 

the total number of positive samples for E. coli. Unchanged and consistent with existing 

provisions under the current TCR, a CWS may provide Tier 3 PN using the annual CCR. 

b. EPA’s rationale. The proposed public notification requirements are consistent with the 

AIP language as well as with the tier system described in 40 CFR part 141 subpart Q. These 

changes are appropriate because some of the types of violations in the proposed RTCR are 

different from the current TCR. The standard health effects language for the public notification 

is also revised as appropriate given the changes to what constitutes a violation under the 

proposed RTCR. 

The proposed Tier 1 PN requirement for an E. coli MCL violation is consistent with the 

current TCR. 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. The 
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existing Tier 1 PN requires public notice as soon as possible but no later than 24 hours after the 

system learns of the violation. Exposure to E. coli in drinking water 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, some of the elderly, and people with 

severely compromised immune systems. 

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 proposed RTCR meets these criteria because it is an 

indication that the public water system failed to conduct an assessment or complete corrective 

action following identification of sanitary defects. Identification of a sanitary defect indicates 

that a problem may exist in the distribution system that has potential to cause public health 

concern. 

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 meet these criteria because, while 

they do represent a violation of the proposed RTCR, the risk to public health is not as clearly 

linked as those that are Tier 1 or 2. Therefore, EPA believes that a public notice given at least 

annually fulfills the public’s right-to-know about these violations. 

Consumer confidence report requirements are updated to reflect the advisory committee’s 

recommendations that total coliforms be used as an indicator to start an evaluation process that, 

where necessary, will require the PWS to correct sanitary defects. EPA believes it is most 
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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 

proposed RTCR. Because the proposed 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 provisions under the proposed RTCR. 

c. Request for comment. EPA requests comment on whether the PN and CCR language 

revisions are consistent with the provisions of the proposed RTCR that reflect the use of total 

coliforms as an indicator within a coliform treatment technique. Since EPA is not aware of 

health effects resulting solely from exposure to total coliforms, the proposed RTCR eliminates 

the public notification requirement for detection of total coliforms, but provides for public 

notification upon detection of E. coli, and for violation of the coliform treatment technique. The 

Agency does request comment, however, on the loss of information to consumers resulting from 

elimination of public notification requirements following positive sample results for total 

coliforms. EPA also requests comment on whether the proposed RTCR should require special 

notice to the public of sanitary defects, in addition to the PN requirements, similar to the GWR 

special notice requirements. This would be consistent with current requirements for other 

regulations that limit pathogens in ground water systems. Under 40 CFR 141.403(a)(7)(i), a 

CWS must inform the public of the significant deficiency and/or fecal indicator-positive sample. 

The CWS must continue to inform the public annually until the significant deficiency is 

corrected or the fecal contamination in the ground water source has been determined by the State 

to be corrected. Under 40 CFR 141.403a)(7)(ii), an NCWS that receives notice from the State of 
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a significant deficiency must inform the public of any significant deficiency that has not been 

corrected within 12 months of being notified by the State, or earlier if directed by the State. The 

NCWS must continue to inform the public annually until the significant deficiency is corrected. 

8. Reporting and recordkeeping requirements for systems 

a. Provisions. i. Reporting. In addition to the existing general reporting requirements 

provided in 40 CFR 141.31, the proposed RTCR requires a PWS to: 

• notify the State no later than the end of the next business day after it learns of an E. colipositive sample. 

• report to the State an E. coli MCL violation no later than the end of the next business day 

after learning of the violation. The PWS is also required to notify the public according to the 

provisions laid out in 40 CFR part 141 subpart Q. 

• report to the State a treatment technique violation 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 to the State monitoring violations within ten days after the system discovers the 

violation, and notify the public in accordance with 40 CFR part 141 subpart Q. 

• notify the State when each scheduled corrective action is completed for corrections not 

completed by the time of the submission of the assessment form. 

In addition, systems triggered into conducting an assessment are required to submit the 

completed assessment form within 30 days after determination that the coliform treatment 

technique trigger has been exceeded (see section III.A.3 of this preamble for additional 

discussion). 
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ii. Recordkeeping. EPA is proposing to maintain the current TCR requirements regarding 

retention of sample results and records of decisions related to monitoring schedules found in 40 

CFR 141.33, including provisions that address the new requirements of the proposed 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. 

b. EPA’s rationale. In the case of an E. coli-positive sample, the proposed RTCR maintains 

the current TCR requirement that systems must notify the State by the end of the day when they 

are notified of the E. coli-positive result or by the end of the next business day if the State office 

is already closed. The advisory committee believed that this requirement is important to 

maintain because of the potential for immediate public health risk associated with E. coli

presence and the desire for States to consider quickly whether additional actions might be 

appropriate. The same rationale applies to E. coli MCL violations. 

Since there are new requirements for conducting assessments and corrective actions, and 

new conditions for obtaining increased or reduced monitoring provisions, the proposed rule 

includes reporting and recordkeeping requirements to facilitate tracking of Level 1 and Level 2 

triggers and compliance with treatment technique requirements. Systems are required to 

maintain these files no less than five years. Since systems have to maintain these files no shorter 

than 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 look at and review these 
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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 timeframe by which reporting and recordkeeping are required under the proposed rule is 

consistent with EPA’s practice regarding reporting and recordkeeping requirements in other 

regulations under SDWA. 

c. Request for comment. EPA requests comment on whether the timeframe required for 

reporting and recordkeeping requirements are appropriate. 

9. Analytical methods 

a. AIP-related method issues. i. Evaluation of currently-approved methods. The AIP 

contains several recommendations by the advisory committee regarding the analytical methods 

approved under the proposed RTCR. The advisory committee noted that the methods currently 

approved under the current TCR have varying sensitivities and specificities, and recommended 

that “... the Agency evaluate all currently approved coliform analytical methods to determine 

whether these methods continue to be appropriate for use in drinking water compliance 

monitoring” (USEPA 2008c, AIP p. 7). 

In the twenty years since the current TCR was promulgated, many methods have been 

developed and approved for use. Most of the approved methods that are used to support the 

current TCR were evaluated under EPA’s Alternate Test Procedure (ATP) process. Under this 

process, a proposed method is evaluated in comparison to a reference method. A favorable 

comparison serves as the basis for subsequent approval of the method for use in regulatory 

compliance monitoring. 

The ATP evaluations are designed based on the ATP Microbiology Protocol (USEPA 2004), 

an EPA guidance document that outlines how the evaluation study should be conducted. In the 
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years the ATP program has been in place, the ATP guidance document has been revised several 

times. As a result of different protocols being used over time, the current set of approved 

methods have not all been evaluated under identical conditions. 

In addition to the concerns expressed by the advisory committee that the approved methods 

may not be equivalent to each other, EPA notes that there have been additional concerns with 

some of the methods currently approved. This includes allegations that some of the approved 

methods may have been modified since approval without EPA’s knowledge. EPA is also aware 

of reports of varying performance of some enzyme-based methods (Oldstadt et al. 2007; Fricker 

et al. 2003). Lastly, EPA is aware of at least one circumstance where the manufacturer of an 

approved method placed a “product hold” and recall on the medium after the product was 

reported to be experiencing reduced recovery of E. coli. 

For these reasons, EPA believes that additional information may be needed regarding the 

performance of the currently approved methods in order to justify their continued approval. 

Among the options, EPA is considering a complete, side-by-side method evaluation study, 

whereby all the methods are compared to each other under identical conditions, according to the 

same protocol. 

EPA is considering an approach under which vendors of all currently approved methods 

would have the option of voluntarily participating in an independent, third-party laboratory 

evaluation through EPA’s Environmental Technology Verification (ETV) Program. The goal of 

the ETV Program is to provide independent, objective, and credible performance data for 

commercial-ready environmental technologies. More information on this program is available 

on EPA's website at www.epa.gov/etv/index. 
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Under the ETV approach, EPA anticipates that participating vendors would generally fund 

the majority of the cost of their method evaluation. Based on the results of the ETV study, as 

documented in the verification report, EPA would judge the appropriateness of each analytical 

method and would determine which should continue to be approved for future monitoring. EPA 

would then make any changes to the analytical methods approved under the RTCR through later 

rulemaking. 

If a vendor chooses not to participate in the ETV study, EPA would allow the vendor to 

propose, for EPA’s consideration, an equivalent alternative approach for method evaluation. 

EPA will determine whether the proposed approach will provide an independent, effective, and 

credible evaluation. EPA emphasizes that any alternative approach would need to be equivalent 

in scope and rigor to the ETV program. As with the ETV study, EPA would use the results from 

an alternative study to judge the appropriateness of each analytical method and would determine 

which methods warrant approval for future monitoring under this regulation. 

As described at EPA’s April 2009 stakeholder meeting, the time required to plan and 

conduct a proper method evaluation, and to assess the results, is such that EPA does not expect 

to be able to complete this effort and to take action on the method evaluation in time for the 

results to be included in the final RTCR. Instead, and to the extent necessary, EPA would 

address the disapproval of any of the current methods, or restrictions on any methods, in 

independent regulatory actions. 

ii. Review of ATP protocol. The AIP further recommends that EPA “engage stakeholders 

in a technical dialogue in its review of the Alternative Test Procedure (ATP) microbial protocol 

for TC/E. coli methods for drinking water to determine if the criteria for acceptance of methods 

are consistent with the intent and objectives of the TCR...” (USEPA 2008c, AIP p. 7). In 
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response, EPA notes that the study plan developed for the re-evaluation of current methods 

(under an ETV or alternative approach) could serve as a starting point for discussions with 

stakeholders regarding the basis for evaluating new methods. The study plan could be used as a 

model for a revised ATP protocol; lessons learned from the re-evaluation could also inform 

EPA’s future assessment of new methods. 

iii. Approval of “24-hour” methods. The AIP also recommends that EPA “consider 

approving methods that allow the timely (e.g. on the order of 24 hours) analytical results for E. 

coli and TC and that provide relatively concurrent analyses, without significantly sacrificing 

accuracy, precision and specificity” (USEPA 2008c, AIP p. 7). EPA notes that many of the 

approved methods that may be used in compliance with the proposed rule can be completed in 

approximately 24 hours. However, the methods that detect lactose fermentation include a 

confirmation step that involves transfer of a presumptively positive culture into a more inhibitory 

confirmation medium which serves to ensure the initial positive was correct. As a result of this 

confirmatory step, lactose fermentation methods can take up to 96 hours to obtain a result. The 

enzyme based methods do not require this confirmation step, and their results can be obtained in 

a 24 to 48 hour time period. 

EPA is aware of some concerns that methods with a 24 hour incubation time may not be 

able to detect as many coliform bacteria as methods with a 48 hour incubation period. Since 

many of the coliform bacteria found in a distribution system are injured or stressed due to 

disinfection practices, and since injured/stressed organisms may take longer to detect than 24 

hours, this concern is of interest to EPA. As part of, or in addition to, the method evaluation 

previously described, EPA may therefore further investigate the impact of incubation time on the 

recovery of stressed/injured organisms in drinking water using approved media. At this time, 
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EPA believes that it is premature to conclude that either enzyme-based or lactose-based methods 

are inherently preferable. 

As discussed during the advisory committee meetings, the analysis time of the analytical 

methods is just one aspect in the overall amount of time it takes before a PWS obtains sample 

results from the laboratory and subsequently collects repeat samples. Factors that can impact 

how quickly the PWS receives notification of a positive result include whether the PWS uses an 

in-house laboratory or must ship the sample to a distant contract laboratory, and whether the 

sample results are reported via an electronic means or via traditional mail. In addition, the 

turnaround time for repeat sampling can be affected by such factors as the laboratory daily hours 

of operation. The current TCR specifies that repeat samples be collected within 24 hours, but 

States currently have the flexibility to extend this timeline. The current TCR does not contain 

provisions for how quickly the laboratory must notify the PWS when a positive result is 

obtained. This proposal does not change these provisions. 

iv. Elimination of fecal coliforms under the proposed RTCR. The AIP also contains a 

recommendation that EPA remove all provisions related to fecal coliforms under the proposed 

RTCR. Consistent with this recommendation, and for the following reasons, EPA is proposing 

to eliminate all fecal coliform provisions in the RTCR. 

First, the fecal coliform group can contain bacteria not associated with fecal contamination. 

E. coli is the most prominent member of the fecal coliform group. However, other coliform 

bacteria, such as thermotolerant strains of Klebsiella spp., have been shown to occur in the fecal 

coliform group (Warren et al. 1978). These non-E. coli bacteria are often found in 

environmental sources (for example, soil, vegetation, water) and, therefore, are not exclusively 

associated with feces. Due to the presence of these non-fecal bacteria, the fecal coliform group 
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may not always provide the public water system with meaningful data regarding the vulnerability 

of their distribution system to fecal contamination. 

Secondly, when the current TCR was developed, there were few E. coli methods available. 

Many public water systems were familiar with and preferred to use the fecal coliform methods. 

However, since the current TCR was promulgated, many E. coli methods have been developed 

and approved for use. EPA believes that most systems nationwide currently test for E. coli, 

while few test for fecal coliform bacteria. Since the methods used to test for E. coli have 

approximately the same cost as those used to test for fecal coliform bacteria, this proposed 

change is not expected to create an additional burden on PWSs. 

EPA is proposing to eliminate all analytical method provisions for fecal coliforms that are 

included in the current TCR. EPA proposes instead to allow testing only for E. coli following a 

total coliform-positive sample. This change will provide the water system with more meaningful 

information regarding potential fecal contamination of the distribution system. 

 The current TCR specifies a number of analytical methods that can be used for compliance 

sample analysis (in 40 CFR 141.21(f)). Since fecal coliform bacteria are not regulated 

contaminants under this proposed rule, the analytical methods for fecal coliforms are no longer 

applicable and are removed from the list of analytical methods. All other methods used for 

compliance with the current TCR are maintained for compliance sample analysis under the 

proposed RTCR. 

v. Request for comment on AIP-related method issues. EPA is requesting comment on the 

following RTCR analytical method issues related to recommendations from the TCRDSAC in its 

AIP: 

• The use of an ETV approach for a reevaluation of analytical methods. 
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• Whether the RTCR should include provisions to ensure a more expedited results 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. 

• Whether the RTCR should require repeat samples be taken within 24 hours of a total 

coliform-positive with no (or limited) exceptions. 

b. Other method issues. In addition to addressing the recommendations of the advisory 

committee, EPA is proposing some minor technical changes related to analytical methods. Many 

of these changes document practices that are already followed by PWSs and laboratories, and are 

consistent with the Manual for the Certification of Laboratories Analyzing Drinking Water 

(referred to as the “Laboratory Certification Manual”)(USEPA 2005), an EPA document that 

outlines method requirements and good laboratory practices for certified laboratories conducting 

drinking water compliance sample analyses. 

Some of these changes were brought to the attention of EPA by EPA Regions and States 

involved in the implementation of the drinking water certification program. Other minor 

changes have been proposed to make the analytical methods section of this regulation easier to 

understand and implement. Each proposed change is described as follows with a discussion of 

the rationale for the change. 

i. Holding time. The proposed RTCR continues to provide a 30-hour holding time limit for 

the samples collected in compliance with this regulation (40 CFR 141.21(f)(3)). However, EPA 

is proposing to change the definition for holding time from “the time from sample collection to 

initiation of analysis may not exceed 30 hours” to “the time from sample collection to initiation 

of test medium incubation may not exceed 30 hours.” 
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ii. Dechlorinating agent for sample preservation of chlorinated water supplies. The 

proposed RTCR establishes the following provision: “If chlorinated water 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) (Clesceri et al. 1998; Eaton et al. 2005). 

iii. Filtration funnels. EPA is proposing to add the following footnote to the analytical 

methods table (§141.852) under the revised rule: 

All filtration series must begin with membrane filtration equipment that has been 

sterilized by autoclaving. Exposure of membrane 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. 

iv. Analytical methods table changes. EPA is proposing the following changes to the 

analytical methods table: 

• The table is organized by methodology (e.g., lactose-fermentation methods vs. enzymesubstrate methods). 

• E. coli methods are included in the table. 

• 18th and 19th editions of Standard Methods for the Examination of Water and Wastewater are 

no longer approved and have been removed. 

• 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 table proposes to allow Standard Methods 9221D in the multiple tube format as 

described in Standard Methods 9221B. 
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• The citation for MI agar is changed to EPA Method 1604 for clarity and consistency. 

• The table clarifies that Standard Methods 9221 F.1 and 9222 G.1a (1), (2) may be used for E. 

coli analysis. 

• The table clarifies the correct formulation for EC-MUG broth, when used in conjunction with 

Standard Methods 9222G.1a(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. 

v. EPA’s rationale for proposed changes related to other method issues. (a). Holding time. 

The current rule states “The time from sample collection to initiation of analysis may not 

exceed 30 hours” (40 CFR 141.21 (f)(3)). Since promulgation of the current TCR, some States 

and EPA Regions have commented that “initiation of analysis” may be interpreted several 

different ways, which can lead to the sample being held longer than the 30 hours intended by the 

rule. The proposed language more clearly defines the amount of time that the sample may be 

held and is consistent with section 6.4.1 of the Manual for the Certification of Laboratories 

Analyzing Drinking Water which states: “For the analysis of total coliform in drinking water, the 

time between sample collection and the placement of sample in the incubator must not exceed 30 

hours.” 

EPA believes that changing the definition of holding time from “the time from sample 

collection to initiation of analysis” to “the time from sample collection to initiation of test 

medium incubation” may slightly decrease the amount of time a PWS has to get the sample to a 

laboratory. EPA does not believe that this change will significantly reduce the amount of time a 
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water system has to get a sample to the laboratory, as most of the methods approved under this 

rule require 30 minutes or less to process and prepare the sample for the incubation step. Thus, 

the initial analytical steps should not constitute a large portion of the holding time as a whole. 

EPA recommends that PWSs that have difficulty meeting the holding time notify the laboratory 

that the samples are in transit and need to be given priority. The laboratory could begin analysis 

immediately upon sample arrival so that the samples could be placed in the incubator in time to 

meet the 30 hour holding time. EPA notes that a laboratory may have to make specific 

accommodations in their processes in order to properly analyze a sample received close to the 

end of the holding time. EPA believes that this is feasible with proper planning. 

(b). Dechlorinating agent for sample preservation of chlorinated water supplies. Under this 

proposal, EPA would require that chlorinated water samples be collected in bottles that contain 

the dechlorinating agent sodium thiosulfate. This is consistent with section 3.15.4 of the 

Laboratory Certification Manual, which states “If chlorinated water 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.” Neutralization ceases the bactericidal action of the 

chlorine during sample transit, thus allowing a more accurate assessment of what the true 

microbial content of the water sample was at the time of sample collection. Implementation of 

this new requirement should be straightforward since PWSs need only ask the laboratory for pretreated sample containers. EPA does not believe this provision will cause an increase in cost to 

PWSs, as the cost of the bottles with the sodium thiosulfate is essentially the same as the cost of 

the bottles without the sodium thiosulfate. 

(c). Filtration funnels. Under this proposal, EPA is requiring that membrane filtration 

equipment be autoclaved before beginning a filtration series. This requirement is consistent with 
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section 4.1.3 of the Laboratory Certification Manual, which states: “Membrane filter equipment 

must be autoclaved before the beginning of a filtration series.” 

Under the current TCR, not all of the approved membrane filtration methods require that a 

filtration series begin with membrane filtration units that have been sterilized by autoclave. 

Some of the approved methods allow the laboratory to use ultraviolet (UV) radiation exposure in 

lieu of autoclaving to sterilize filtration units between filtration series. EPA does not believe that 

ultraviolet radiation is sufficient to properly sterilize the membrane filtration equipment. 

Additionally, EPA believes that when ultraviolet radiation is used, not all areas of the membrane 

filtration equipment are exposed, and therefore microorganisms may persist and contaminate 

other water samples and the laboratory. For these reasons, EPA is proposing to include a 

footnote to the analytical methods table in order to ensure proper sterilization. 

EPA does, however, believe that ultraviolet light can be used to sanitize the filtration 

equipment between filtrations within a filtration series, as stated in section 4.1.4 of the 

Laboratory Certification Manual: “Ultraviolet light (254 nm) may be used to sanitize equipment 

(after initial autoclaving for sterilization), if all supplies are pre-sterilized. Ultraviolet light may 

be used to reduce bacterial carry-over between samples during a filtration series.” 

(d). Analytical methods table. In this proposal, EPA is identifying a number of changes to 

the analytical methods table for clarity and accuracy. 

In the current TCR, the methods are listed by date approved and the E. coli methods are 

listed in a text format. In this proposal, the analytical methods table is organized by 

methodology (e.g., lactose-fermentation methods vs. enzyme-substrate methods), and the E. coli 

methods are included in the table. 
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Standard Methods for the Examination of Water and Wastewater is a reference document 

designed to represent “the best current practice of American water analysts." Periodically, new 

editions are published in order to incorporate improvements in the methods contained within this 

manual. Thus, new editions of this publication contain more current and improved versions of 

the methods. Under the current TCR, four editions of this publication are approved, resulting in 

different, oftentimes outdated, versions of the same method being approved. Having multiple 

editions of this manual approved under this regulation also creates a burden for the laboratory 

certification officers who must understand the differences between the versions of the method for 

which the laboratory may be seeking certification. For these reasons, EPA is proposing to 

remove the 18th and 19th editions of Standard Methods for the Examination of Water and 

Wastewater for use in compliance sample analysis under the RTCR. EPA expects that the 

burden associated with this change will be minimal as most laboratories have already procured 

the newer editions or have arranged for access to the online publication. 

In this proposed regulation, the reference to Standard Methods 9221A and 9222A are 

removed. These sections of the methods contain only introductory information, not any actual 

methodology. They do not represent methods approved for use under this regulation. 

The references to Standard Methods 9221B and 9221D are modified in this proposed 

regulation. In the current TCR, the methods are referenced as 9221B and 9221D with footnote 5 

denoting that the “completed phase” called for in the methods is not required. By more 

specifically citing Standard Methods 9221 B.1, B.2, and 9221 D.1, D.2 (which contain the 

applicable, required steps of these methods) EPA is able to eliminate the original footnote and 

improve clarity. 
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EPA is proposing to allow Standard Methods 9221D (Presence-Absence broth) to be used in 

a multiple tube format. This method has traditionally been used in a single bottle, allowing only 

the qualitative detection of total coliforms. However, there are published reports showing this 

method can be used in a multiple tube format for the quantitative detection of total coliforms 

(Rice et al. 1987; Rice et al. 1993). This medium would be used in the same manner that Lauryl 

Tryptose Broth (LTB) is described as being used in Standard Methods 9221B. Allowing the use 

of this method in a multiple tube format would allow PWSs that use this method to quantitate 

any total coliforms that may occur in the water sample. 

EPA is proposing to change the citation for MI Agar. Under the current TCR, this method is 

cited as Standard Methods 9222, with a footnote citing the Applied and Environmental 

Microbiology article where the method was initially described. In this proposal, the method is 

now cited as EPA Method 1604, consistent with section 5.4.2.1.3 of the Laboratory Certification 

Manual. EPA Method 1604 is identical to the citation in the TCR and does not require the use of 

the original footnote. This change is also consistent with the citation of this method as listed in 

the Ground Water Rule (see 40 CFR 141.402). 

The current TCR describes the use of “EC medium supplemented with 50 g/mL of 4-

methylumbelliferyl-Beta-D-glucuronide (MUG)” (see 40 CFR 141.21(f)(6)(i)). This proposal 

clarifies that this medium, included in both Standard Methods 9221F and Standard Methods 

9222G.1a(2), is approved for use under this regulation. This is consistent with the Laboratory 

Certification Manual, particularly section 5.1.8, which describes both of these methods as 

approved for use in the detection of E. coli under this regulation. 

Lastly, EPA is clarifying the formulation for EC broth with MUG (EC-MUG) given in 

Standard Methods 9222G.1a(2) to correct an error in the publication. The Standard Methods 
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9222G.1a(2) formulation calls for 0.1 g of 4-methylumbelliferyl-Beta-D-glucuronide, and 1.4g 

KH2PO4. This formulation differs from that given in Standard Methods 9221F.1, which calls for 

0.05 g and 1.5 g, respectively. EPA believes that the correct formulation is given in Standard 

Methods 9221F and has confirmed this with Standard Methods committee members (Rice 2009). 

Accordingly, EPA has added a footnote to the 9222G.1 a (2) stating the proper formulation. 

EPA anticipates that these changes to the analytical methods table will not cause any 

additional burden to the PWSs. 

vi. Request for comment regarding holding temperature. The current TCR states the 

following regarding sample shipment: “Systems are encouraged but not required to hold 

samples below 10 deg. C during transit.” Other national primary drinking water regulations 

requiring microbial sampling require that the samples be shipped in cold conditions, and require 

the sample be maintained at a temperature of 10 degrees Celsius (C) or less. Maintaining the 

sample temperature below 10 degrees C serves to preserve the bacterial population by 

minimizing both bacterial cell death and cell multiplication, thus allowing for a more accurate 

representation of the microbial population in the sample at the time of sample collection. Also, 

Standard Methods for Examination of Water and Wastewater, 21st edition (Eaton et al. 2005) 

recommends that samples be shipped at less than 8 degrees C but not frozen. 

In the years since the promulgation of the current TCR, EPA has heard concern that at times, 

samples collected under the TCR may reach high temperatures during transit to the laboratory 

due to the lack of a requirement to ship samples on ice. High temperatures that may be reached 

during transit could have a deleterious or prolific effect on the bacterial cells present in the 

samples such that the samples may no longer represent the microbial content of the water at the 

time of sample collection. 
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EPA recognizes that requiring the samples under the proposed RTCR to be held at 10 

degrees C or less, but above freezing, would result in an increased cost to the water systems (for 

shipping, supplies, etc.), but believes the extra burden may be warranted. EPA is seeking public 

comment on whether this passage should remain as is in the current TCR or whether the RTCR 

should require that the samples collected for compliance with this regulation be shipped in cold 

conditions, i.e., requiring a temperature of 10 degrees C or less, but above freezing to be 

maintained for better sample preservation. EPA also welcomes comments and supporting data 

on what the acceptable temperature range should be when samples are in transit. 

B. Proposed Compliance Date 

Consistent with SDWA section 1412(b)(10), EPA proposes that the compliance date of the 

final RTCR be three years from the date on which the regulation is promulgated (i.e., the 

publication date of the final rule in the Federal Register). PWSs must comply with the 

requirements of the rule by the compliance date. 

EPA believes that capital improvements generally are not necessary to ensure compliance 

with the proposed 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). 

EPA requests comment on the proposed compliance date of the proposed RTCR.

C. Links to Other Drinking Water Rule Requirements 

The proposed RTCR recognizes that existing NPDWRs contain linkages among monitoring 

requirements in different rules. The current residual disinfectant monitoring must be conducted 

at the same time and location at which TCR samples are taken, as provided for in the Surface 

Water Treatment Rule (SWTR) (USEPA 1989b, 54 FR 27486, June 29, 1989) and the Stage 1 
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Disinfectants and Disinfection Byproducts Rule (Stage 1 DBPR) (USEPA 1998a, 63 FR 69389, 

December 16, 1998). Under the GWR, TCR distribution system monitoring results determine 

whether a system is required to conduct source water monitoring. Under the SWTR, high 

measurements of turbidity in an unfiltered subpart H system trigger additional total coliform 

samples. Sanitary survey provisions exist in surface water and ground water drinking water 

regulations. The proposed RTCR does not change the existing sanitary survey requirements 

except to add the special monitoring evaluation that States must conduct at systems serving 

4,100 or fewer people. These evaluations do not increase the burden to conduct sanitary surveys 

because of the relatively simple nature of these systems and their monitoring requirements. 

1. SWTR, Stage 1 and Stage 2 DBPRs, ADWR 

After considering the possible linkages among the proposed RTCR and the SWTR, Stage 1 

DBPR, Stage 2 DBPR (USEPA 2006e, 71 FR 388, January 4, 2006), and Airline Drinking Water 

Rule (ADWR) (USEPA 2009e), EPA has concluded that the only necessary revision is to update 

the reference to the current TCR at 40 CFR 141.21, which is superseded by 40 CFR part 141 

subpart Y beginning three years following publication of the final rule. EPA is also proposing 

several revisions to other NPDWRs, discussed below, that are not necessary but would facilitate 

implementation of all applicable NPDWRs. 

2. GWR 

As with the other drinking water rules mentioned above, EPA is proposing to update the 

references in the GWR to the current TCR at 40 CFR 141.21, which will be superseded by 40 

CFR part 141 subpart Y. In addition, EPA is proposing to revise portions of the GWR triggered 

source monitoring requirements that allow for a sample taken at the ground water source to also 
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qualify as a repeat sample under the current TCR. The discussion on repeat samples can be 

found in section III.A.4 of this preamble. 

3. Sanitary surveys 

Sanitary survey requirements are not included in the proposed RTCR. Under the current 

TCR, community water systems and non-community water systems that serve 4,100 or fewer 

people are required to conduct periodic sanitary surveys. Since the promulgation of the TCR in 

1989, new sanitary survey requirements for surface water systems and ground water systems 

have been established for all system sizes and types under the Interim Enhanced Surface Water 

Treatment Rule (IESWTR) (USEPA 1998b, 63 FR 69477, December 16, 1998) (40 CFR 

142.16(b)(3)), and the Ground Water Rule (GWR) (40 CFR 142.16(o)(2)(i)). Public water 

systems began implementing the IESWTR sanitary survey requirements in 2001. Therefore, for 

surface water systems, the current TCR sanitary survey requirements have phased out since that 

time. Implementation of the GWR sanitary survey requirements begin in December 2009 for 

ground water systems. Therefore, for ground water systems, the GWR sanitary survey 

requirements will be in effect by the time the RTCR is finalized. 

D. Best Available Technology (BAT) 

1. Provisions 

The proposed RTCR would maintain the provisions set forth in 40 CFR 141.63(d) (proposed 

to be in §141.63(e)), regarding the best technology, treatment techniques, or other means 

available for achieving compliance with the MCL of either total coliforms or E. coli. EPA is 

proposing the following modifications: 

• 40 CFR 141.63(d)(1) (proposed §141.63(e)(1)) would be modified by replacing “coliforms” 

with “fecal contaminants.” 
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• 40 CFR 141.63(d)(3) (proposed §141.63(e)(3)) would be modified by including “cross 

connection control” in the list of proper maintenance practices for the distribution system. 

• 40 CFR 141.63(d)(4) (proposed §141.63(e)(4)) would be modified by including the subparts 

P, T, and W that describe filtration and/or disinfection of surface water, and subpart S for 

disinfection of ground water. 

2. EPA’s rationale 

a. Change “coliform” to “fecal contaminants.” This change reflects the approach of the 

proposed RTCR that the presence of total coliforms does not necessarily have a direct public 

health implication. Instead, total coliform is used as an indicator of a potential pathway of 

contamination within a treatment technique requirement. For additional discussion on this topic, 

see section III.A.2 of this preamble. 

b. Inclusion of cross connection control. EPA believes that adding cross connection control 

to the list of proper maintenance practices for distribution systems is appropriate because of the 

significant contribution of cross connections and backflow to waterborne disease outbreaks. 

From 1981 to 1998, the CDC documented 9, 734 detected and reported illnesses from 57 

waterborne outbreaks related to cross connections (NRC 2006). From 1970 to 2001, 

approximately 12,000 illnesses resulted from 459 incidents of waterborne outbreaks from 

backflow events (NRC 2006). 

c. Addition of other relevant subparts of 141. This change adds references to subparts that 

contain provisions for the other drinking water rules promulgated since 1989 when the TCR was 

promulgated (in particular, subpart P for the IESWTR, subpart S for the GWR, subpart T for the 

Long Term Enhanced Surface Water Treatment Rule (USEPA 2002, 67 FR 1812, January 14, 

2002, and subpart W for the Long Term 2 Enhanced Surface Water Treatment Rule (USEPA 
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2006d, 71 FR 654, January 5, 2006)). These drinking water rules contain updated filtration and 

disinfection standards that were not part of the current TCR when it was promulgated in 1989. 

3. Request for comment 

EPA requests comment on the modifications to the existing BATs and whether there is a 

need to add or otherwise update the list of BATs. 

E. Variances and Exemptions 

1. Provisions 

EPA is proposing to not allow variances or exemptions to the E. coli MCL. EPA is also 

proposing to eliminate the variance provisions in 40 CFR 141.4(b) 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 will also result in a parallel 

change in 40 CFR 142.63(b). 

2. EPA’s rationale 

Under the proposed RTCR, E. coli is used as an indicator of fecal contamination that may 

contain waterborne pathogens. To the extent a variance or exemption would permit the 

continued presence of E. coli, the potential for pathogens to be present also would remain. EPA 

believes that water which 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. This 

provision is consistent with the existing requirement, since the provision that allows variances 

applies only to the monthly/non-acute total coliform MCL violation and not to the acute violation 

associated with the presence of E. coli. 

Under the current TCR, EPA allows variances to the MCL for total coliforms when a system 

has demonstrated to the State that the violation of the total coliform MCL is due to a persistent 
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growth of total coliforms in the distribution system (i.e., biofilm) rather than fecal or pathogenic 

contamination, a treatment lapse or deficiency, or a problem in the operation or maintenance of 

the distribution system. 

EPA is proposing to eliminate the variance in 40 CFR 141.4(b) because under the proposed 

RTCR, there would no longer be an MCL for total coliforms (see section III.A.2 of this 

preamble). The current TCR MCL for total coliforms was based on the presence or absence of 

total coliforms in a sample (see 40 CFR 141.63 for details). In the proposed RTCR, the presence 

of total coliforms at a certain level requires the system to comply with the coliform treatment 

technique requirements (see section III.A.5 of this preamble). The assessment and corrective 

action requirements under this proposed rule include the possibility of recognizing that the total 

coliform presence is associated with biofilm. EPA plans to include this information in a new 

assessment and corrective action guidance manual related to the RTCR. 

3. Request for comment 

EPA requests comment on its proposal to allow no variance or exemption to the E. coli 

MCL and to eliminate the variance provisions associated with the monthly/non-acute total 

coliform MCL. 

F. Request for Comment on Other Issues Related to the Proposed RTCR 

1. Consistency between the proposed RTCR and the GWR 

EPA requests comment on the need for general consistency between the proposed RTCR 

and the GWR. Please provide specific examples. For example, under the current TCR, States 

are required to keep records of their decision to either waive or extend the 24-hour limit for 

collecting samples (that is, for repeat samples following a total coliform-positive sample, or for 

follow-up samples after high levels of turbidity) (see 40 CFR 142.14(a)(5)(i)(A) and 
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142.14(a)(5)(ii)(D)). The proposed RTCR also requires States to keep records of decisions to 

either waive or extend the 24-hour limit for repeat samples following a total coliform-positive 

sample, for samples following invalidation, or for follow-up samples after high levels of 

turbidity (see §§142.14(a)(10)(i)(A) and 142.14(a)(10)(ii)(D) of the proposed RTCR). Under the 

GWR, there are no recordkeeping requirements for the decision to waive or extend the 24-hour 

limit. Instead, the GWR includes special primacy requirement to describe criteria the State will 

use to extend the 24-hour limit (see 40 CFR 142.16(o)(3)(i)). EPA requests comment on 

whether it is appropriate to have States describe their criteria for waiving or extending the 24-

hour limit as a primacy condition, or instead have States keep records of decisions to waive 

and/or extend the 24-hour limit. 

2. Storage tank inspection and cleaning 

EPA requests comment on the value and cost of periodic storage tank inspection and 

cleaning. There are instances of storage tanks being the source of waterborne disease outbreaks 

at PWSs. In December 1993, a Salmonella typhimurium outbreak in Gideon, Missouri resulted 

in over 600 people affected by diarrhea, 31 cases of laboratory-confirmed salmonellosis and 

seven deaths of nursing home residents who had exhibited diarrheal illness (four deaths were 

confirmed by culture). The larger of the two storage tanks had a breach in the roof hatch that 

allowed pigeon droppings to be carried into the tank and likely accumulated in the several inches 

of sediment. This contaminated sediment, more than likely, was pulled into the distribution 

system by a flushing program that drained the tank (Clark et al. 1996). Salmonella typhimurium

was isolated from the sediment of one of the towers, and tap water tested positive for fecal 

coliforms (CDC 1996). 
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In March 2008, Alamosa, Colorado (with a population of about 9,000 people) experienced a 

waterborne disease outbreak associated with Salmonella. The report released by the Colorado 

Department of Public Health and Environment (Falco and Williams 2009) indicated that the 

outbreak resulted in 442 reported cases of illnesses, 122 of which were laboratory confirmed, and 

one fatality. The State epidemiologist estimated that a total of 1,300 people may have been ill. 

Two storage tanks in Alamosa had several inches of sediment and breaches; one tank had 

breaches large enough for birds and animals to enter Some of the key factors that contributed to 

these two outbreaks include significant levels of sediment (several inches to feet) and the 

presence of breaches of the integrity of the storage tank. 

Sediment accumulation occurs within storage facilities due to quiescent conditions which 

promote particle setting. Over time sediment continues to accumulate in a tank, even if the 

finished water is consistently treated to below 0.1 nephelometric turbidity unit (NTU). For 

surface water systems, it is not uncommon to have 1⁄4 to 1⁄2 inch or more of sediment accumulate 

after two to three years (Kirmeyer et al. 1999). While there are no turbidity regulations for 

ground water systems (except for ground water under the direct influence of surface water 

(GWUDI)), the levels of turbidity can be significant in the water pumped from an aquifer. Sand 

particles, if allowed to accumulate, provide pore spaces that house diverse populations of biota 

(which may include pathogenic microorganisms) (Kirmeyer et al. 1999; van der Kooij 2003). 

Periodic high flows in the storage tank may scour, stir up, and suspend the sediment (along with 

entrapped bacteria and pathogens) and carry it into the distribution system, with greater 

accumulation of sediment being a more significant concern. Other water quality problems 

associated with sediment accumulation include increased disinfectant demand and disinfection 

byproduct formation. 
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The storage tank’s vulnerability to contamination increases when breaches of the storage 

tank allow insects, animals, and birds and their associated diseases to enter. Contamination from 

bird and other animal excrement can potentially transmit disease-causing organisms to the 

finished water. Waterfowl, for example, are known carriers of many different waterborne 

pathogens including Vibrio cholerae (Ogg et al. 1989). 

 Based on the potential public health implications associated with poorly maintained storage 

tanks (e.g., as indicated by significant sediment accumulation and breaches), EPA is interested in 

receiving comments and supporting information regarding the state and condition of tanks that 

have been cleaned and inspected, costs of storage tank inspection and cleaning, and how public 

health can be better protected. EPA requests information on whether there are States that 

recommend or require periodic inspection and cleaning of storage tanks. If so, what are the 

requirements, the frequency of inspection and cleaning, and how successful are they? Are 

inspections and cleaning done by individual PWSs or by contractors? 

3. States under EPA direct implementation 

EPA does not have the authorities provided to other primacy agencies under 40 CFR part 

142 to use in implementing rules in direct implementation entities (e.g., Tribal systems and 

Wyoming). To provide EPA the flexibility of other primacy agencies to modify monitoring 

requirements as necessary to protect public health (e.g., to require more stringent monitoring or 

to develop criteria such as those that primacy States develop under the special primacy 

conditions requirement in 40 CFR 142.16) and facilitate implementation of this rule. EPA is 

requesting comment on whether the Agency should have the same authorities specified in 

subpart Y, as States have in 40 CFR 142.16, for PWSs for which the Agency has direct 
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implementation responsibilities. EPA is requesting comment on whether this authority should be 

added to subpart Y specifically. 

G. Limitations to the Public Comment on the Proposed RTCR 

The proposed revisions to other drinking water regulations (SWTR, Stage 1 DBPR, Stage 2 

DBPR, and ADWR) are made solely to update the reference to the current TCR at 40 CFR 

141.21, which will be superseded by 40 CFR part 141 subpart Y beginning three years following 

publication of the final rule. This proposed rule would not change any substantive requirements 

of those rules and EPA is not soliciting public comments on those rules other than their proposed 

revised references to the current TCR or any other references to the current TCR that EPA may 

need to revise. 

IV. State Implementation 

The proposed 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. While the proposed rule provides 

some reduction in monitoring relative to the current TCR, overall, the proposed rule is more 

stringent and better protects public health. As a result, States must adopt these revisions, when 

final, or adopt or maintain more stringent requirements, in order to maintain primacy. This 

section describes the regulations and other procedures and policies States must adopt in order to 

obtain primacy to implement the RTCR, if finalized as proposed today. 

SDWA section 1413 establishes requirements that States or eligible Indian Tribes must meet 

to assume and maintain primary enforcement responsibility (primacy) for its PWSs. These 

requirements include: 
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• Adopting drinking water regulations that are no less stringent than Federal drinking water 

regulations; 

• Adopting and implementing adequate procedures for enforcement; 

• Keeping records and making reports available on activities that EPA requires by regulation; 

• Issuing variances and exemptions (if allowed by the State), under conditions no less stringent 

than allowed under SDWA; and 

• Adopting and being capable of implementing an adequate plan for the provisions of safe 

drinking water under emergency situations. 

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. 

Section 1413(a)(1) of SDWA provides two years (plus up to two more years if the 

Administrator approves) after promulgation of the final RTCR for the State to adopt 

corresponding drinking water regulations in order to obtain primacy for the final RTCR. To 

implement the final RTCR, States would be required to adopt or maintain requirements that are 

at least as stringent as the following revisions to 41 CFR part 141: 

• Section 141.4 - Variances and exemptions (if allowed by the State). 

• Section 141.21 - Coliform sampling. 

• Section 141.52 - Maximum contaminant level goals for microbiological contaminants. 

• Section 141.63 - Maximum contaminant levels (MCLs) for microbiological contaminants. 

• Section 141.74 - Analytical and monitoring requirements. 

• Section 141.132 - Monitoring requirements. 

• Subpart 141.153 - Content of the reports. 
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• Subpart 141.202 - Tier 1 Public Notice – Form, manner, and frequency of notice. 

• Subpart 141.203 - Tier 2 Public Notice – Form, manner, and frequency of notice. 

• Subpart 141.204 - Tier 3 Public Notice – Form, manner, and frequency of notice. 

• Subpart O - Consumer Confidence Reports, Appendix A, Regulated Contaminants. 

• Subpart Q - Public Notification of Drinking Water Violations, Appendix A, NPDWR 

Violations and Other Situations. 

• Subpart Q - Public Notification of Drinking Water Violations, Appendix B, NPDWR 

Violations and Other Situations. 

• Subpart Y - Revised Total Coliform Rule. 

EPA’s regulation at 40 CFR part 142 sets out the specific 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 basic primacy requirements 

specified in 40 CFR part 142, States may be required to adopt special primacy provisions 

pertaining to specific regulations where implementation of the rule involves activities beyond 

general primacy provisions. States must include these regulation-specific provisions in their 

application for approval of their program revision. States must continue to meet all other 

conditions of primacy for all other rules in 40 CFR part 142. Primacy requirements for the 

proposed RTCR are described below. 

The advisory committee recognized that this rule will require more tracking to ensure 

effective implementation. Therefore, EPA plans to release an upgrade to SDWIS/State and 

SDWIS/FED (the State and Federal versions of the Safe Drinking Water Information System, 

respectively) within 18 months of final rule promulgation to accommodate monitoring data, 
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tracking, compliance determinations and reporting of all rule related requirements, as 

appropriate.

A. State Special Primacy Requirements 

To ensure that a State program includes all the elements necessary for an effective and 

enforceable program under the proposed RTCR, a State primacy application must include a 

description of how the State will perform the following: 

• 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 must 

adopt the reduced monitoring provisions of 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. 

• 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 

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 subpart Y – States must describe 

their criteria and process to invalidate total coliform-positive and E. coli-positive samples 

under subpart Y. 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 
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reflects circumstances or condition that does not reflect water quality in the distribution 

system. 

• Approval of individuals allowed to conduct subpart Y Level 2 assessments – States must 

describe their criteria and process for approval of individuals allowed to conduct subpart Y 

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: 

− Continuous disinfection entering the distribution system and a residual in the distribution 

system; 

− Cross connection control; 

− Other enhancements to water system barriers; and 

− Procedures for seasonal systems to start up operations at the beginning of each season. 

B. State Recordkeeping Requirements 

The current regulations in 40 CFR 142.14 require States with primacy to keep records, 

including: analytical results to determine compliance with MCLs, MRDLs, and treatment 

technique requirements; PWS inventories; State approvals; enforcement actions; and the issuance 

of variances and exemptions. The proposed RTCR requires States to keep additional records, 
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including all supporting information and an explanation of the technical basis for each decision 

as follows. Records of the following decisions or activities must be retained for five years, 

consistent with recordkeeping requirements for existing regulations: 

• Any 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 to collect a total coliform 

sample following a turbidity measurement exceeding 1 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 proposed 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 proposed RTCR, the 

record of the decision must contain all the items listed in that paragraph. 

• Completed and approved 40 CFR part 141 subpart Y assessments, including reports from the 

system that corrective action has been completed. 

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: 

• 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 proposed 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 
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quarter, as provided in §141.854(e) of the proposed 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 proposed 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 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. 

C. State Reporting Requirements 

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 proposed 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. 

D. Interim Primacy 
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On April 28, 1998, EPA amended its State primacy regulations at 40 CFR 142.12 to 

incorporate the new process identified in the 1996 SDWA Amendments for granting primary 

enforcement authority to States while their applications to modify their primacy programs are 

under review (USEPA 1998c, 63 FR 23361, April 28, 1998). The new process 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. This interim 

enforcement authority begins on the date of the primacy application submission or the effective 

date of the new or revised State regulation, whichever is later, and ends when EPA makes a final 

determination. However, this interim primacy authority is only available to a State that has 

primacy (including interim primacy) for every existing NPDWR in effect when the new 

regulation is promulgated. 

As a result, States that have primacy (including interim primacy) for every existing NPDWR 

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. 

E. Request for Comment 

EPA requests comment on the adequacy of the proposed RTCR requirements for State 

implementation, including but not limited to State special primacy requirements and State 

reporting and recordkeeping requirements. Specifically, EPA requests comment on whether 

there are any requirements that should be added to assure proper State oversight, or any that can 

be removed without detriment to implementation of the rule. 

V. Distribution System Research and Information Collection Activities 
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A. Research and Information Collection Partnership 

The advisory committee recommended that a Research and Information Collection 

Partnership (RICP) be formed to inform and support the drinking water community in 

developing future national risk management decisions pertaining to drinking water distribution 

systems. The advisory committee recommended seven priority areas for research and 

information collection. These seven priority areas are: (1) cross-connection and backflow of 

contaminated water; (2) contamination due to storage facility design, operation, or maintenance; 

(3) contamination due to main installation, repair, or rehabilitation practices; (4) contaminant 

intrusion due to pressure conditions and physical gaps in distribution system infrastructure; (5) 

significance and control of biofilm and microbial growth; (6) nitrification issues that lead to 

public health effects; and (7) accumulation and release of contaminants from distribution system 

scales and sediments (USEPA 2008c, AIP p. 30). 

In January 2009, EPA and the Water Research Foundation (WRF or the Foundation) signed 

a memorandum of understanding (MOU) to form the RICP in response to recommendations 

from the advisory committee contained in the AIP (USEPA and WRF 2009). The MOU conveys 

the partners’ agreement to collaborate and identify, define, prioritize, coordinate, and 

communicate critical decision-relevant distribution system research and information collection 

needs of the drinking water community. The RICP is directed by a steering committee 

comprised of nine members: three members from EPA, three members from water utilities, and 

three additional members representing the public health, environmental advocate, and State 

regulator perspectives. 

The partners are developing a distribution system research and information collection 

agenda that focuses on characterizing and reducing public health risks. The identified priority 
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information and research will allow better understanding and management of potential public 

health risks from drinking water distribution systems. See [INSERT WEB LINK WHEN IT 

BECOMES AVAILABLE] for further information on this effort. 

B. Distribution System Optimization Activities 

As part of the AIP, the advisory committee encouraged “the development of national and 

regional distribution system optimization partnerships that focus on protecting the integrity of 

drinking water quality once it is delivered to the distribution system. The purpose of the 

partnerships should be to inform and inspire proactive systems to implement best management 

practices that emphasize protection of public health. These partnerships, comprised, for 

example, of representatives from utilities, communities, academia, and regulatory organizations 

could develop continuous improvement programs that encompass water distribution optimization 

principles and practices for system design, operations, and maintenance. These partnerships 

should foster continuous review of distribution system issues and should define excellence in 

distribution system operation in terms of processes, systems, procedures, as well as measures. 

The optimization partnerships should encourage voluntary program participation of all drinking 

water utilities regardless of system size” (USEPA 2008c, AIP p.25). 

EPA is aware of two distribution system optimization programs that are currently being 

developed. EPA and the Foundation are concurrently developing distribution system 

optimization programs that focus on protecting public health in the distribution system. 

Developmental activities to support these efforts are occurring through the EPA’s National Area 

Wide Optimization Program (AWOP) and the Foundation’s project #4109. While these 

programs are being developed independently with differing measures of performance, both are 

founded on the optimization principles of improving water systems, and go beyond the 
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regulatory requirements, while using existing staff and facilities. These principles and practices 

are currently being used through the in-plant treatment optimization programs operated through 

AWOP and the American Water Works Association’s (AWWA) Partnership for Safe Water (the 

Partnership). For more information on the Partnership for Safe Water, see 

(http://www.awwa.org/Resources/PartnershipforSafeWater.cfm?ItemNumber=3787&navItemNu

mber=33969). 

The goal of EPA’s optimization program is to protect public health by addressing both the 

technical and management issues that limit the water system’s ability to meet water quality 

performance goals. EPA has started developing a distribution system optimization program, 

which is currently focused on improving water treatment plant finished water quality while 

maintaining disinfectant residual and minimizing disinfection byproduct formation in the 

distribution system. Future work may focus on other water quality parameters or issues of 

concern. An outcome of this effort will be the identification of the key technical and 

management skills, practices, and tools that a water system should implement to achieve longterm distribution system optimization. Ultimately, participating AWOP States will be introduced 

to distribution system optimization methods developed by EPA. At this time, additional 

development activities are needed before a distribution system optimization program will be 

available for State implementation. 

In 2007, the Foundation initiated project #4109 to identify a limited number of 

straightforward criteria that can be used by water utilities to measure distribution system 

optimization performance and to develop a self-assessment approach using standards of 

excellence. The results from this project will also be used to expand the Partnership for Safe 

Water Program treatment plant optimization program into distribution system optimization. The 
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Foundation anticipates project #4109 to be completed by early 2010. With the results of project 

#4109, the Partnership anticipates finalizing a preliminary set of optimization goals and a model 

assessment process in calendar year 2010. Prior to finalizing the goals and assessment process, 

the Partnership will conduct trials at several volunteer utilities. The optimization goals and 

assessment process will be evaluated and refined based on those trials prior to consideration by 

the Partnership for adoption and implementation. AWWA anticipates that applications for the 

Partnership’s Distribution System Optimization Program will be available in calendar year 2011. 

C. Request for Comment 

EPA requests comment about these distribution system optimization projects and 

information about or suggestions for other possible approaches to distribution system 

optimization.

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

This section summarizes the Health Risk Reduction and Cost Analysis (HRRCA) in support 

of the proposed RTCR as required by section 1412(b)(3)(C) of the SDWA. EPA has prepared 

the RTCR Economic Analysis (EA) (USEPA 2009a) to comply with this requirement. The EA 

document for the proposed RTCR is available in the docket and is also published on the 

government’s Web site at http://www.regulations.gov. 

The HRRCA consists of 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 
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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. See SDWA section 

1412(b)(3)(C). A summary of these elements is provided in this section of the preamble, and a 

complete discussion can be found in the Proposed RTCR EA (USEPA 2009a). 

Both the benefits and the costs discussed in this section are presented as annualized present 

values in 2007 dollars 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 consumption (USEPA 2000c). 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 rates of return on relatively risk-free 

investments, as described in the Guidelines for Preparing Economic Analyses (USEPA 2000c). 

The rate of seven percent is a recommendation of the Office of Management and Budget (OMB) 

as an estimate of “before-tax rate of return to incremental private investment” (OMB 1996). 

In the Proposed RTCR EA (USEPA 2009a), EPA also presents the undiscounted stream of 

benefits and costs over the 25-year time frame (i.e., the year-to-year realization of benefits and 

costs presented in constant terms). 

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. 

EPA was unable to quantify health benefits for the proposed 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 
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Review 2 dataset described in this preamble were limited to presence-absence data because the 

current 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 Proposed RTCR EA 

(USEPA 2009a), even though health benefits could not be directly quantified, the potential 

benefits from the proposed 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, since 

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 

contaminants. 

The net costs of the rule stem mostly from the new assessment corrective action 

requirements as well as the revised monitoring provisions described earlier in this preamble. 

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 

Proposed RTCR, (F) Anticipated Costs of the Proposed RTCR, (G) Potential Impact of the 

Proposed 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 Proposed RTCR, (M) Benefit Cost Determination for the Proposed RTCR, and (N) Request 

for Comment. 

A. Regulatory Options Considered 

EPA evaluated the following three regulatory options as part of this revised rule proposal: 

(1) the current TCR option, (2) the AIP option, and (3) an Alternative option. EPA discusses the 
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three regulatory options briefly in this preamble and in greater detail in chapter 3 of the Proposed 

RTCR EA (USEPA 2009a). 

First, the current TCR option reflects EPA’s understanding of how the current TCR (USEPA 

1989a, 54 FR 27544, June 29, 1989) is currently being implemented. That is, the current TCR 

option is assumed to include “status quo” PWS and State implementation practices. Next, the 

AIP option is a revised TCR based on the recommendations of the advisory committee. The 

provisions of this proposed rule are based on the AIP option and are described in detail in section 

III of this preamble. Third, the Alternative option parallels the AIP in most ways but includes 

variations of some of the provisions that were discussed by the advisory committee before 

consensus was reached on the AIP. 

The Alternative option differs from the AIP 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 (corresponding to the 11th year of the model runs presented later on in this 

preamble). This more stringent approach differs from the AIP 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 Proposed RTCR EA (USEPA 2009a) to assess the relative 

impacts of a more stringent rule and to better understand the balance between costs and public 

health protection. 
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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 Proposed 

RTCR EA (USEPA 2009a).

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 proposed RTCR. For a more detailed discussion, see chapter 4 of the 

Proposed RTCR EA (USEPA 2009a).

1. Safe Drinking Water Information System Federal Version 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 proposed 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)). 
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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 Proposed 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 (acute) MCL violations (current 

TCR, AIP, and Alternative option), total coliform (non-acute or monthly) MCL violations 

(current TCR), and Level 1 and Level 2 assessment triggers (AIP and Alternative option) for 

systems serving more than 4,100 people. 

2. Six-Year Review 2 data 

Through an Information Collection Request (USEPA 2006b), States voluntarily submitted 

electronically available TCR monitoring data (sample results) that were collected between 

January 1998 and December 2005. EPA requested the TCR monitoring results with the intent of 

conducting analyses and developing models to assess the potential impacts of changes to the 

current TCR. EPA received data from 46 States, Tribes, and territories. A Data Quality Report 

(USEPA 2009c) describes how 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) 
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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 Proposed RTCR EA (USEPA 

2009a), EPA used 2005 data exclusively in the analyses supporting the proposed 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 

GWSs 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 Proposed 

Revised Total Coliform Rule (proposed RTCR T&C document) (USEPA 2009b), 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.1 of this preamble, the model developed for 

this economic analysis considers the effect of GWR both before and during implementation of 
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the proposed revised rule. The proposed RTCR T&C document included estimates of unit costs 

for the major components of the proposed RTCR 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 Proposed RTCR EA (USEPA 2009a). 

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 EPA is proposing new 

monitoring requirements for PWSs serving 4,100 people or fewer, proposed monitoring 

requirements for systems serving greater than 4,100 people remain essentially unchanged. This 

section briefly discusses the structures of each of the two models and how they used available 

data, information, and assumptions to make predictions over time resulting from the proposed 

regulatory options. 
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Chapter 5 of the Proposed RTCR EA (USEPA 2009a) 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 public water systems serving 4,100 or fewer 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 (TCR, AIP, 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 current TCR. It assumed that cycles of normal 

deterioration and repair/replacement are occurring at the individual system level, on average. 

However, 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 TCR violations over the last several years which shows that national 

violation rates have remained relatively steady over the past several years. Revisions to the TCR 

affect this steady state, likely resulting in a reduction of the underlying occurrence and associated 

violations. However, before the RTCR goes into effect, GWR implementation begins which is 

also expected to affect the steady state. 
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Exhibit VI-1 Number of PWSs with Violations by System Type (2001 – 2007) 

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. 

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 current TCR with GWR. EPA assumed five years to account for the 

approximately two years before the expected promulgation date of 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 Proposed RTCR EA (USEPA 2009a) 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 not providing 

4-log treatment for viruses that have total 

coliform-positive samples under current TCR 

are required to take source water samples and 

test for fecal indicator. If the sample is 

positive, they must take an additional 5 source 

Current model used same probabilities used in 

GWR EA (USEPA 2006a) to predict whether 

source water samples will be E. coli-positive. 

GWSs required to conduct corrective action due 

to monitoring results will either install 
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water samples (unless the State requires 

corrective action). If any of these is positive, 

they must conduct corrective action.

disinfection or implement a nondisinfecting 

corrective action as described in Proposed 

RTCR EA (USEPA 2009a). 

GWSs installing disinfection will draw from the 

probability distributions for total coliforms and 

E. coli for disinfected systems for the remainder 

of analysis. 

GWSs 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 GWSs, 

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 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 

that are conducting compliance monitoring once 

assumed 4-log treatment for viruses begins. 

1,2,3Assumption reflects EPA best professional judgment. 

Source: Proposed RTCR EA (USEPA 2009a) as informed by GWR EA (USEPA 2006a). 

Actual reductions in occurrence that are expected to result 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 AIP and Alternative option perform relative to each other are 

not affected. 

In addition to capturing the effect of implementation of GWR requirements with the current 

TCR for a five-year period of analysis, the model captures an additional 25 years with the current 

TCR, the AIP 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 
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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 

reduced monitoring requirements. The assumptions used to simulate RTCR implementation are 

detailed in the Proposed RTCR EA (USEPA 2009a) and summarized in Exhibit VI-3. 

Exhibit VI-3 Summary of Major Assumptions for Simulating Proposed RTCR 

Implementation 

Proposed 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 current TCR). 

All sanitary defects are corrected. Model selects from distribution of 

potential corrective actions as explained in chapter 7 of the Proposed 

RTCR EA (USEPA 2009a). 

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 current TCR). 

All sanitary defects are corrected. Model selects from distribution of 

potential corrective actions as explained in chapter 7 of the Proposed 

RTCR EA (USEPA 2009a). 

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. 
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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: Proposed RTCR EA (USEPA 2009a) 

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 

the corrective actions that result from a Level 2 assessment were modeled to 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. 

2. Model used for public water systems serving more than 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 current TCR, AIP, 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 TCR. 

D. Baseline Profiles 
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The estimate of baseline conditions that EPA developed provides a reference point for 

understanding net impacts of the proposed rule revisions. 

Compliance with the GWR begins in December 2009, and the expected compliance date of 

the RTCR is approximately five years following commencement of the GWR implementation. 

The majority of PWSs are GWSs 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 GWSs, the baseline conditions that EPA developed for GWSs account for the expected effects 

of the GWR. 

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 PWSs that disinfect is expected to change during implementation of the 

GWR before the expected rule compliance date of the proposed RTCR. Exhibit VI-4 shows the 

estimated baseline number of the GW PWSs at the proposed RTCR compliance date. 

Exhibit VI-4 Estimated Baseline Number of GW Systems and Disinfection Status 

at compliance date (3 years post RTCR promulgation) 
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Disinfecting Non-Disinfecting Disinfecting Non-Disinfecting Disinfecting Non-Disinfecting 

≤100 6,308 5,630 2,937 5,889 13,781 46,419

101 - 500 9,326 4,566 2,777 3,836 5,459 13,816

501-1,000 3,516 951 873 845 685 1,278

1,001-4,100 5,423 1,020 547 265 274 343

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 Million 4 - - - - 1

> 1 Million 3 - - - - -

Total 27,746 12,555 7,192 10,849 20,226 61,900

Combined Total 

PWS Size

Number of GW PWSs (Post-GWR)

40,301 18,041 82,126

CWS NTNCWS TNCWS

Source: Proposed RTCR Occurrence and Predictive Model Output as detailed in the Proposed 

RTCR EA (USEPA 2009a) 

EPA estimated the numbers of GW PWSs that monitor monthly, quarterly, and annually 

under the current TCR based on an analysis of the Six-Year Review 2 data and individual State 

statutes conducted by EPA and the advisory committee Technical Workgroup (TWG). Of the 

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 current TCR or for the AIP option. 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 
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PWS

Type

Source

Water

Population

Served

TC

(# Samples)

TC

(+ Samples)

TC

(% Positive)

EC

(# Samples) 1

EC

(+ Samples)

EC

(% Positive)2

≤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%

≤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%

≤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%

≤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%

≤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%

≤100 1,668 32 1.92% 30 4 0.24%

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%

NTNCWS

GW

SW

CWS

GW

SW

TNCWS

GW

SW

1 Number of E. coli samples is the denominator of the E. coli percent positive calculation, and 

includes the number of total coliform 

negative samples plus the number of total coliform-positive samples that were tested for E. coli. 2

 Percent E. coli-positive was calculated as (number of E. coli-positive samples)/(number of E. 

coli samples taken). 

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 Rule Compliance Monitoring Data Quality and Completion 

Report (USEPA 2009c) includes a detailed description of this data cleaning process.
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Exhibit VI-6 presents the number of acute and non-acute violations received by PWSs. The 

number of violations is also an indicator of baseline water quality prior to implementation of the 

proposed RTCR. As discussed in detail chapter 5 of the Proposed RTCR EA (USEPA 2009a), 

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 current 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) 
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Non-Acute Acute Total Non-Acute Acute Total

≤100 905 52 957 16 19 3 976 

101-500 809 34 843 50 57 7 900 

501-1,000 203 13 216 16 19 3 235 

1,001-3,300 272 280 8 55 62 7 342 

3,301-10,000 171 179 8 75 78 3 257 

10,001-50,000 125 133 8 78 82 4 215 

50,001-100,000 11 13 2 5 4 22 9 

100,001-1 Million 1 1 2 3 1 4 6 

>1 Million - - - 1 - 1 1 

Totals 2,497 2,623 126 299 331 32 2,954 

≤100 514 34 548 7 2 557 9 

101-500 346 20 366 4 - 370 4 

501-1,000 57 63 6 2 - 65 2 

1,001-3,300 58 62 4 - - - 62

3,301-10,000 9 11 2 1 - 12 1 

10,001-50,000 - 1 1 - - - 1 

50,001-100,000 - - - - - - - 

100,001-1 Million - - - - - - - 

>1 Million - - - - - - - 

Totals 985 1,051 66 14 16 2 1,067 

≤100 2,665 2,943 278 19 24 5 2,967 

101-500 833 76 909 11 12 1 921 

501-1,000 133 11 144 4 - 148 4 

1,001-3,300 58 60 2 1 - 61 1 

3,301-10,000 - 5 5 1 - 6 1 

10,001-50,000 - - - - - - - 

50,001-100,000 - - - - - - - 

100,001-1 Million - - - - - - - 

>1 Million - - - - - - - 

Totals 3,694 4,061 367 36 42 6 4,103 

Grand Total 7,176 7,735 559 349 389 40 8,124 

TNCWSs

All PWSs 

Total

GW PWSs SW PWSs

CWSs

NTNCWSs

Note: The proposed 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: SDWIS/FED 2005 3rd quarter data. OH, US territories, Tribal PWS data excluded. See 

the Proposed RTCR EA (USEPA 2009a) for additional details. 

E. Anticipated Benefits of the Proposed 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 current TCR. The options 

considered during development of this proposed rule and analyzed as part of the Proposed RTCR 
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EA (USEPA 2009a) 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 current 

TCR option, the AIP 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 

proposed RTCR. EPA used several methods to qualitatively evaluate the benefits of the 

proposed 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 

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 proposed RTCR. Also, since 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 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 
Document initiating EO 12866 review 

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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 proposed 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 

proposed RTCR is more stringent that the current TCR with regard to protecting public health. 

The basis for this perspective is provided in this subsection and the following subsections 

(sections VI.E.1 – 3) of this preamble. 

Risk reduction for the proposed 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 
Document initiating EO 12866 review 

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cost prohibitively more than the periodic sampling practiced under the current TCR and included 

in the AIP and the Alternative options. EPA’s objective in proposing the sampling schedules 

included in the AIP and Alternative options was to find an appropriate balance between the 

factors of risk mitigation and cost management. 

Under the AIP and Alternative options, the reduction in the number of repeat samples and 

additional routine samples for some PWSs has the potential to contribute to increased risk for 

PWS customers (see also sections III.A.3 and III.A.4 of this preamble for discussions on the 

repeat sample and additional routine sample provisions respectively). However, this increase in 

risk is expected to be more than offset by potential decreases in risk from increased routine 

monitoring (see section III.A.3 of this preamble) and the addition of the assessments and 

corrective action provisions (see section III.A.5 of this preamble) 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 AIP and Alternative options. As 

discussed previously, the proposed RTCR uses total coliform occurrence as an indicator of 

potential pathways for possible contamination to enter the distribution system (see section III.A.2 

of this preamble). 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 illustrated. The relative trends indicated in Exhibit VI-7 for transient 

non-community water systems also pertain to other PWS categories as illustrated in chapter 5 of 

the Proposed RTCR EA (USEPA 2009a). EPA chose to include the characterization for 

TNCWSs because they represent the system category of largest influence on the national 

impacts. 

Exhibit VI-7 GW Transient Non-community Water System Total Coliform Occurrence 
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Source: Proposed RTCR occurrence model as described in the Proposed RTCR EA (USEPA 

2009a). 

The effect that the proposed changes to public notification requirements for monthly/nonacute MCL violations have 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. 

Other proposed rule components are expected to have a negligible effect on risk. However, the 
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overall effect of the proposed RTCR is expected to be a further reduction in risk from the current 

baseline risk under the current TCR. Chapter 6 of the Proposed RTCR EA (USEPA 2009a) 

presents a detailed discussion of the potential influence on health risk for each proposed rule 

component. 

Exhibit VI-8 Potential Changes in Risk under the AIP and Alternative Options Relative to 

the Current TCR 

Proposed Rule 

Component 

Factors Leading to a 

Potential Increase in Risk 

Factors Leading to a 

Potential Decrease in Risk 

Overall Predicted 

Change in Risk 

AIP Alternative AIP Alternative AIP 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 

and 

therefore 

monitor 

more 

frequently 

than under 

the baseline 

for reduced 

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 current 

TCR. After the 

first few years, 

systems may 

reduce to 

quarterly, but 

none may 

reduce to 

annual 

monitoring, 

creating a 

decrease in risk 

for systems on 

Decrease Decrease 
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monitoring) annual 

monitoring 

under the 

current TCR 

Repeat 

Monitoring 

Required 

repeat 

samples 

reduced 

from 4 to 3 

for systems 

serving 

<1,000 

people 

Same as AIP 

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 AIP 

option 

None None Increase Increase 

Annual 

Inspections 

None (only 

States 

currently 

performing 

annual 

inspections 

are expected 

to continue) 

Based on 

discussions 

with 

stakeholders, 

States that 

currently 

conduct 

annual site 

assessments 

under the 

current TCR 

may no 

None (only 

States 

currently 

performing 

annual 

inspections 

are expected 

to continue) 

None No 

change Increase 
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longer have 

the resources 

to continue 

the 

inspections 

and conduct 

quarterly 

monitoring 

under the 

Alternative 

option 

Assessments None None 

Mandatory 

assessments 

are a new 

requirement 

Same as AIP 

option Decrease Decrease 

Corrective 

Actions None None 

Mandatory 

corrective 

actions are a 

new 

requirement 

Same as AIP 

option Decrease Decrease 

Public 

Notification – 

Monthly/NonAcute MCL 

Violations 

Reduction in 

available 

public 

information 

Possible 

PWS 

complacency 

Same as AIP 

option 

Less 

confusion 

(PN more in 

line with 

potential 

health risks) 

PWSs 

resources 

used more 

efficiently 

Same as AIP 

option Unknown Unknown 

Public 

Notification – 

Monitoring and 

Reporting 

Violations 

None None 

Increased 

stringency 

of PNs 

motivates 

PWSs to 

conduct 

required 

sampling 

Same as AIP 

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 Proposed RTCR EA (USEPA 2009a). 

Implementation activities consist of administrative activities by PWSs and States to implement 

the rule. 
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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 are discussed in section 6.2 of the Proposed RTCR EA. 

Chapter 3 of the Proposed 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 proposed RTCR. Specifically, EPA modeled the 

predicted outcomes based on each regulatory option considered – baseline (current TCR), the 

AIP, and the Alternative option – in the form of estimates of non-acute violations for the current 

TCR and assessment triggers for the AIP 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 current TCR results in estimates of annual 

non-acute and acute violations (current TCR) and assessment triggers (AIP and Alternative 

options). Section 6.4 of the Proposed RTCR EA (USEPA 2009a) presents a step-wise sensitivity 
Document initiating EO 12866 review 

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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 

alternatives compared to the current TCR. The results of this sensitivity analysis showed that for 

all categories of systems, more total coliform and E. coli positives are prevented than missed 

under both regulatory options. 

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 TCR with the AIP 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 million samples) under both the TCR and AIP. For the Alternative option, the 

analysis predicts that approximately 87 million 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 

TCR, AIP, 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 current TCR and AIP options. 

Because similar total numbers of samples are taken under each 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 AIP option compared to the current TCR option and is a 
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reflection of overall better water quality. The second comparison can then be made of the 

Alternative option against the AIP option. In each graph, the predicted results (assessments, E. 

coli MCL violations, and corrective actions) for the Alternative option are above those for the 

AIP option and represent an additional benefit over the AIP 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 when 

all systems are 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 Proposed RTCR EA (USEPA 2009a). 

Exhibit VI-9 shows the effect (on average across all PWSs) of the AIP and the Alternative 

options on the annual number of non-acute violations (TCR) and assessment triggers (AIP and 

Alternative options) over time. The estimated reduction of annual assessment triggers (from the 

current TCR estimates of non-acute violations) by approximately 1,000 events under the AIP 

option is a reflection of the improved water quality expected under the AIP option. A similar but 

smaller reduction in non-acute violations (Level 1 triggers) from the current 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 AIP option reflects the 

diagnostic abilities provided by increased sampling under the Alternative option. The additional 
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triggers identified by increased sampling under the Alternative option translate into greater 

potential benefits than under the AIP option. 

Exhibit VI-10 shows the effect (on average across all PWSs) of the AIP and the Alternative 

option with respect to E. coli violations found over the 25-year period of analysis in comparison 

to the current TCR. The overall reduction in annual E. coli violations under the AIP option of 

more than 100 events is a measure that should correlate closer to 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 is seen under the Alternative option after steady state is achieved. 

The larger initial reduction followed by a higher steady state number for the Alternative option 

than seen under the AIP reflects the diagnostic abilities provided by increased sampling under 

the Alternative option. The additional E. coli violations identified by increased sampling under 

the Alternative option translate into greater potential benefits than under the AIP. 

Exhibit VI-11 presents estimates over the 25-year period of analysis of the increase in 

corrective actions (on average across all PWSs) attributable to the regulatory options considered. 

Performance of these additional corrective actions is expected to result in the most direct benefits 

under the proposed RTCR. Because only the incremental numbers of corrective actions 

estimated under the AIP and Alternative options were modeled, the reference point for 

comparison to the current TCR is the base (zero) line in the graph. The Proposed RTCR EA 

(USEPA 2009a) assumes that corrective actions are already being performed under the current 

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 regulatory 

options considered. 
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Exhibit VI-11 indicates that more corrective actions are implemented under the Alternative 

option than under the AIP option. This is driven, again, by the increased diagnostic power of 

more sampling and reflects additional potential benefits beyond those gained under the AIP 

option. 

Taken together, Exhibit VI-9 through Exhibit VI-11indicate that the modeled endpoints for 

the AIP and Alternative options predict positive benefits in comparison to the current TCR; in 

particular, the Alternative option captures more benefits than the AIP 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 AIP, and both provide more benefit than the 

current TCR. These outcomes are consistent with the qualitative assessment of the benefits 

summarized in section VI.E.1. 

The major difference between the AIP option and 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 AIP 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 current TCR at first, the trend is due to initially finding 

more 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 AIP and 

Alternative option as eligible systems qualify for less intense (quarterly) monitoring under the 
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Alternative option. However, the Alternative option leads to a greater number of assessments, E. 

coli MCL violations, and corrective actions than the AIP option because all PWSs are required to 

sample no less than quarterly under the Alternative option while under the AIP 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). 

Exhibit VI-9 Estimates of Non-Acute Violations (TCR) and Level 1 Assessment Triggers 

(AIP and Alternative Option) 

5,000 

6,000 

7,000 

8,000 

9,000 

10,000 

11,000 

12,000 

13,000 

14,000 

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Non-Acute Violations (TCR) and Level 1 Assessment Triggers (AIP 

and Alt Options) (Nondiscounted Values)

Time (Years)

TCR - Non-Acute Violations

AIP Option - Level 1 Assessment Triggers

Alt Option - Level 1 Assessment Triggers

Notes: X-axis begins at Year 4 after rule promulgation, which is the first year of full 

implementation of the proposed RTCR (AIP option) or Alternative option. The annual rates of 

non-acute violations (TCR) and Level 1 assessment triggers (AIP 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 monitor monthly, quarterly, and annually is assumed to remain 
Document initiating EO 12866 review 

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relatively constant. Estimates represent the annual number of assessment triggers found by each 

option and the non-acute violations found under the TCR. 

Source: Proposed RTCR occurrence model output. 

Exhibit VI-10 Estimates of Acute Violations (TCR) and E. coli MCL Violations (AIP and 

Alternative Options) 

400 

500 

600 

700 

800 

900 

1,000 

1,100 

1,200 

1,300 

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Acute Violations (TCR) and E. coli MCL Violations (AIP and Alt 

Options) (Nondiscounted Values)

Time (Years)

TCR - Acute Violations

AIP Option - E. coli MCL Violations

Alt Option - E. coli MCL Violations

Notes: X-axis begins at Year 4 after rule promulgation, which is the first year of full 

implementation of the proposed RTCR (AIP option) or Alternative option. The annual rates of 

acute violations (TCR) and E. coli MCL violations (AIP 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 

the 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 TCR. 

Source: Proposed RTCR occurrence model output. 

Exhibit VI-11 Estimates of Corrective Actions 
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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 Acitons (Nondiscounted Values)

Time (Years)

AIP Option - Corrective Actions

Alt Option - Corrective Actions

Notes: X-axis begins at Year 4 after rule promulgation, which is the first year of full 

implementation of the proposed RTCR (AIP option) or 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 the monitor monthly, quarterly, and annually 

is assumed to remain relatively constant. All corrective actions performed are in addition to 

activity under the current TCR, which does not require corrective actions. Therefore the current 

TCR is not included in this graph. 

Source: Proposed RTCR occurrence model output. 

 

Exhibit VI-12 Discounted Estimates of Non-Acute Violations (TCR) and Level 1 

Assessment Triggers (AIP and Alternative Options) (three percent discount rate) 
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0 

1,000 

2,000 

3,000 

4,000 

5,000 

6,000 

7,000 

8,000 

9,000 

10,000 

11,000 

12,000 

13,000 

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Non-Acute Violations (TCR) and Level 1 Assessment Triggers (AIP 

Option and Alt Option) (Present Value, 3% Discount Rate)

Time (Years)

TCR - Non-Acute Violations

AIP Option - Level 1 Assessment 

Triggers

Alt Option - Level 1 Assessment 

Triggers

Notes: X-axis begins at Year 4 after rule promulgation, which is the first year of full 

implementation of the proposed RTCR (AIP option) or Alternative option. The annual rates of 

non-acute violations (TCR) and Level 1 assessment triggers (AIP 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 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 TCR. 

Source: Proposed RTCR occurrence model output. 

Exhibit VI-13 Discounted Estimates of Acute Violations (TCR) and E. coli

Violations (AIP and Alternative Options) (three percent discount rate) 
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0 

100 

200 

300 

400 

500 

600 

700 

800 

900 

1,000 

1,100 

1,200 

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Acute Violations (TCR) and E. coli MCL Violations (AIP Option and 

Alt Option) (Present Value, 3% Discount Rate)

Time (Years)

TCR - Acute Violations

AIP Option - E. coli MCL Violations

Alt Option - E. coli MCL Violations

Notes: X-axis begins at Year 4 after rule promulgation, which is the first year of full 

implementation of the proposed RTCR (AIP option) or Alternative option. The annual rates of 

acute violations (TCR) and E. coli MCL violations (AIP 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 

the 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 TCR. 

Source: Proposed RTCR occurrence model output. 

Exhibit VI-14 Discounted Estimates of Corrective Actions (three percent discount rate) 
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0 

100 

200 

300 

400 

500 

600 

700 

800 

900 

1,000 

1,100 

1,200 

1,300 

1,400 

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Corrective Acitons (Present Value, 3% Discount Rate)

Time (Years)

AIP Option - Corrective Actions

Alt Option - Corrective Actions

Notes: X-axis begins at Year 4 after rule promulgation, which is the first year of full 

implementation of the proposed RTCR (AIP option) 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 the monitor monthly, quarterly, and annually 

is assumed to remain relatively constant. All corrective actions performed are in addition to 

activity under the current TCR, which does not require corrective actions. Therefore the current 

TCR is not included in this graph. 

Source: Proposed RTCR occurrence model output. 

The quantified portion of the benefits analysis focuses on several measures that contribute to 

the reductions in risk expected under the proposed RTCR. Specifically, EPA modeled the 

predicted outcomes based on each regulatory option considered – baseline (current TCR), the 
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AIP, and the Alternative option – in the form of estimates of non-acute violations for the current 

TCR and assessment triggers for the AIP and Alternative options; E. coli violations; and the 

number of corrective actions implemented under each option. 

 The previous discussion presented a summary of the estimated impacts of both regulatory 

options considered in comparison to the current TCR. Evaluation of each of these outcomes 

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 level 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 leads to a reduction in total coliform and E. coli

positives being found, which in turn 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 current TCR results in estimates of annual non-acute and acute violations (current TCR) and 

assessment triggers (AIP and Alternative option). Section 6.4 of the Proposed RTCR EA 

(USEPA 2009a) 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 alternatives compared to the current TCR. The results of this 

sensitivity analysis showed that for all categories of systems, more total coliform and E. coli

positives are prevented than missed. 

3. Nonquantifiable benefits 

a. Potential decreased incidence of endemic illness from fecal contamination, waterborne 

pathogens, and associated outbreaks. As discussed in section VI of this preamble and chapter 2 
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of the Proposed RTCR EA (USEPA 2009a), benefits from the proposed 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 

disease, waterborne disease outbreaks, and death. Also, since 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 contaminants. 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 sections III.A.2 and III.A.9 of this preamble. 

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 these other contaminants and the associated primary and secondary 

endemic disease burden, both acute and chronic. 
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b. Other nonquantifiable benefits. Other nonquantified health benefits may include 

decreased incidence of outbreaks, epidemic illness and deaths associated with fecal 

contamination and/or waterborne pathogens. The nonquantified non-health benefits include 

increased knowledge regarding system operation, accelerated maintenance and repair, avoided 

costs of outbreaks, and reductions in averting behavior. 

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 proposed 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 current 

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. 

In addition to benefits from additional preventive maintenance, some systems may 

accelerate their capital replacement fund investments in response to early identification of 

impending problems with large capital components. Although such capital investment will 

eventually occur anyway, earlier investment may ensure that problems are addressed in a 

preventive manner and may preclude some decrease in protection that might have occurred 
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otherwise. At the very least, the increased operator awareness is expected to reduce the 

occurrence of unplanned capital expenditures in any given year. 

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 proposed RTCR may also 

lead to a reduction of costs associated with boil-water orders, which some States require 

following non-acute violations under the current 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 costs, to be over $45.9 million in 2007 Canadian dollars (approximately 42.8 

million 2007 US dollars) (Livernois 2002). The author of the study believed that this was a 

conservative estimate. 

In addition, the proposed RTCR may also reduce uncertainty regarding drinking water 

safety, which may lead to reduced costs for averting behaviors. Averting behaviors include the 

use of bottle 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 Proposed RTCR 

To understand the net impacts of the proposed 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 current TCR. Then, EPA 

considered the net change in costs that result from implementing the AIP or Alternative options 
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as compared to the costs of continuing with the current TCR. The objective was to present the 

net change in costs resulting from revisions to the current TCR rather than absolute totals. More 

detailed information on cost estimates are described in the sections that follow and a complete 

discussion can be found in chapter 7 of the Proposed RTCR EA (USEPA 2009a). A detailed 

discussion of the proposed revisions is located in section III of this preamble.

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. 

Exhibit VI-15 summarizes the comparison of total and annualized present value of the net 

change difference in cost from the baseline for each of the three regulatory scenarios (current 

TCR, AIP option, and Alternative option). A continuation of the current TCR will result in no 

net change in costs. The net change in mean annualized present value national costs of the AIP 

option 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 are estimated to be approximately $27M using a three percent discount rate 

and $30M using a seven percent discount rate. Given these low net costs, both options are below 

the threshold of a “significant regulatory action” under Executive Order 12866 as discussed in 

chapter 9 of the Proposed RTCR EA (USEPA 2009a) and in section VII.A of this preamble. 
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Under the AIP option, public water systems are estimated to incur greater than 90 percent of 

the proposed revised rule’s net annualized present value costs. States are expected to incur the 

remaining costs. 

Exhibit VI-16 presents the comparison of total and net change in annualized present value 

costs 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 under both the AIP and 

Alternative options. For States, revising sampling plans contribute most to the cost increase. For 

both PWSs and States, a net decrease in costs associated with PN requirements helps to offset the 

total net cost increase. 

Exhibit VI-15 Comparison of Total and Net Change in Annualized Present Value 

Costs ($Millions, 2007$) 

PWSs State Total PWSs State Total 

 3% Discount Rate 7% Discount Rate 

TCR – Total 

 $ 

185 

 $ 

0.9 

 $ 

186 

 $ 

178 

 $ 

0.9 

 $ 

179 

AIP – Total 

 $ 

199 

 $ 

1.1 

 $ 

200 

 $ 

191 

 $ 

1.3 

 $ 

192 

AIP - Net Change 

 $ 

14 

 $ 

0.1 

 $ 

14 

 $ 

13 

 $ 

0.4 

 $ 

14 

AIP - Percent Change 7% 16% 7% 7% 48% 8%

Alternative option - Total 

 $ 

212 

 $ 

1.2 

 $ 

213 

 $ 

207 

 $ 

1.5 

 $ 

209 

Alternative option - Net Change 

 $ 

27 

 $ 

0.3 

 $ 

27 

 $ 

29 

 $ 

0.6 

 $ 

30 

Alternative option - Percent 

Change 15% 32% 15% 16% 67% 17%

Note: Detail may not add due to independent rounding. 

Source: Proposed RTCR EA (USEPA 2009a). 
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Exhibit VI-16 Comparison of Total and Net Change in Annualized Present Value 

Costs by Rule Component ($Millions, 2007$) 

Note: Assumes a certain level of assessment activity already 

occurs under the current TCR, as discussed in chapter 7 of the 

Proposed RTCR EA (USEPA 2009a). 
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Source: Proposed RTCR EA (USEPA 2009a). 

2. PWS costs 

Like the current TCR, the proposed 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 current 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 AIP ($5.1M) or Alternative option ($13.4M) because of the large number of systems. 

On a per system basis, this translates to a net annualized present value increase of approximately 

$83 per system under the AIP and $217 per system under the Alternative option for the TNCWSs 

serving 100 or fewer people. As described in section VII.C of this preamble, none of the small 

TNCWSs are estimated to have costs that are greater than or equal to three percent of their 

revenue. 

The total net change in national annualized present value costs for all PWSs serving greater 

than 4,100 people (approximately $6M using three percent discount rate) is the same under the 

AIP and Alternative option. This is expected because the provisions for PWSs serving greater 

than 4,100 are the same under either option. Monitoring requirements for PWSs serving greater 

than 4,100 people remain essentially unchanged under either the AIP 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 ($Millions, 2007$) 
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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 the complete costs for regulatory implementation but only to the 

specific costs considered to calculate net changes in costs. 

Source: Proposed RTCR cost model. 

a. Rule implementation and annual administration. Under the AIP and Alternative options, 

all PWSs subject to the proposed 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 current TCR option is 

maintained. Under the AIP and Alternative options, all PWSs subject to the proposed 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 
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understand the rule, and a total of eight hours to plan and assign appropriate personnel and 

resources to carry out rule activities. 

b. Revising sampling plans. Under the AIP and Alternative options, all PWSs subject to the 

proposed RTCR incur one-time costs to revise existing sampling plans to identify sampling 

locations and collection schedules that are representative of water throughout the distribution 

system. Under the TCR, no additional burden or costs are expected to be incurred by PWSs to 

revise sampling plans, as these PWSs are already collecting total coliform samples in accordance 

with a written sampling plan. Based on previous experience, EPA estimated that PWSs require 

2-8 hours to revise their sampling plan, depending on PWS size. 

c. Monitoring. Monitoring costs for PWSs are calculated by multiplying the total numbers 

of routine, additional routine, and repeat samples required under the current TCR, AIP, and 

Alternative options by the monitoring costs per sample. Under the AIP, the increased stringency 

to qualify for reduced monitoring results in more routine samples being taken over time (fewer 

PWSs are on reduced monitoring). 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 AIP option. The resulting increases in costs due to increased 

monitoring are reflected in the routine monitoring costs. 

The overall reductions in the numbers of additional routine samples required under the AIP 

and Alternative option result in reduced costs. Cost reductions are greater under the Alternative 

option than under the AIP because under the Alternative option all PWSs start on monthly 

monitoring and are not required to take additional routine samples during that period. 
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Under the current 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. The number of repeat 

samples required for PWSs serving more than 1,000 people is the same under the current TCR 

and the AIP and Alternative options. 

Exhibit VI-18 summarizes the cumulative number of samples taken by PWS size and 

category for routine, additional, and repeat monitoring under the TCR, AIP, and Alternative 

option over the entire 25-year period of analysis. Under the current TCR option, approximately 

82.1 million samples are taken over the 25-year period of analysis compared to approximately 

82.2 million samples under the AIP option and approximately 87.9 million samples under the 

Alternative option (less than 10 percent more than current TCR option). Appendix A of the 

Proposed RTCR EA (USEPA 2009a) presents additional information on the number of samples 

taken each individual year during the analysis period. 

The annualized net present value total and net change cost estimates for PWSs and States to 

perform monitoring under the TCR, AIP, and Alternative options and are presented in Exhibit 

VI-19. 

Exhibit VI-18 Cumulative Number of Samples over 25-Year Period of Analysis for 

Baseline (TCR) and Regulatory Alternatives (AIP and Alternative option) 
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Exhibit VI-19 Annualized National PWS and State Monitoring Cost Estimates ($Millions, 

2007$) 

 3% discount rate 7% discount rate 

TCR - Total $ 179.57 $ 172.57 

AIP - Total $ 180.65 $ 173.46 

AIP - Net Change $ 1.08 $ 0.90 

AIP - Percent Change 0.60% 0.52% 

Alternative option – 

Total $ 192.53 $ 187.53 

Alternative option - 

Net Change $ 12.96 $ 14.96 

Alternative option - 

Percent Change 7.22% 8.67% 

Note: Detail may not add due to independent rounding. 

Source: Proposed RTCR EA (USEPA 2009a) 

The overall estimated increase in monitoring costs seen under the AIP 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 required under the 

revised regulations. 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 due to reductions in additional routine monitoring 

requirements.

d. Site inspections. Under the AIP, any PWS on an annual monitoring schedule is required 

to also have an annual site inspection conducted by the State or State-designated third party. A 

voluntary Level 2 site assessment can also satisfy the site inspection 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. EPA uses the same assumptions to estimate costs associated with site visits for 

both the AIP and Alternative options
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e. Assessments. Annualized cost estimates for Level 1 and Level 2 assessments under the 

TCR, AIP, and Alternative options are calculated by multiplying the number of assessments 

estimated by the predictive modeling (summarized in Exhibit 7.13) by the unit costs presented in 

chapter 7 of the Proposed RTCR EA (USEPA 2009a). Appendix A of the Proposed RTCR EA 

(USEPA 2009a) provides a detailed breakout of the number of Level 1 and Level 2 assessments 

estimated by the occurrence model. Annualized cost estimates are presented in Exhibit VI-20. 

Exhibit VI-20 Annualized National PWS Costs Estimates for Assessment Activity (current 

TCR) and Level 1 and Level 2 Assessments (AIP and Alternative Options) ($Millions, 

2007$) 

3% discount rate 7% discount rate

TCR - Total $ 1.13 $ 1.08

AIP - Total $ 1.63 $ 1.57

AIP - Net Change $ 0.50 $ 0.49

Alternative Option - Total $ 1.73 $ 1.69

Alternative Option - Net Change $ 0.60 $ 0.60

TCR - Total $ 0.70 $ 0.68

AIP - Total $ 0.90 $ 0.88

AIP - Net Change $ 0.20 $ 0.20

Alternative Option - Total $ 1.23 $ 1.27

Alternative Option - Net Change $ 0.52 $ 0.60

Level 1 Assessments

Level 2 Assessments

Note: EPA estimated the level of assessment activity conducted by PWSs thought 

to occur under the current TCR, as discussed in chapter 7 of Proposed RTCR EA 

(USEPA 2009a) 

Detail may not add due to independent rounding. 

Source: Proposed RTCR cost model, described in chapter 7 of the Proposed 

RTCR EA (USEPA 2009a) 

Under the AIP, the overall number of assessments (both Level 1 and Level 2) decreases as a 

function of reduced fecal indicator occurrence over time. However, PWS costs increase slightly 

due to the higher unit cost of performing assessments compared to existing practices under the 

TCR. The total net change in cost is estimated to be positive. 
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The overall number of assessments is larger under the Alternative option compared to the 

AIP option. This is a result of the initial monthly monitoring requirements for all PWSs under 

this analysis. 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 TCR, results in a higher net cost increase for the 

Alternative option than under the AIP. The total net change in cost for the Alternative option is 

estimated to be positive, and nearly twice as high as under the AIP option. See Exhibit 7.15 of 

the Proposed RTCR EA (USEPA 2009a).

f. Corrective actions. Under the AIP 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 AIP and Alternative options. EPA assumed that any corrective actions based on a 

positive source water sample are accounted for under the GWR and not under the proposed 

RTCR. Based on discussions with State representatives, EPA assumed that additional corrective 

actions are performed for only 10 percent of the assessments undertaken as a result of the 

proposed RTCR representing the net increase over the current 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-21 based on best professional judgment. . 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 
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anticipated. EPA used best professional judgment 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 Proposed RTCR EA (USEPA 

2009a), 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 the Technology and Cost Document 

for the Proposed Revised Total Coliform Rule (USEPA 2009b). 

Exhibit VI-21 Compliance Forecast for Corrective Actions based on Level 1 and Level 2 

Assessments 

As shown in the compliance forecast in Exhibit VI-21, EPA 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 
Document initiating EO 12866 review 

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flushing program as opposed to a single flushing, based on EPA and stakeholder best 

professional judgment. Level 1 assessments generally are less involved than Level 2 

assessments and may result in finding less complex problems. 

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. 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 section 7.7 of the Proposed RTCR EA (USEPA 2009a). 

As indicated in the more detailed analysis presented in chapter 7 of the Proposed RTCR EA 

(USEPA 2009a), 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. The total and net change costs of corrective actions are shown in Exhibit VI-22. 

Exhibit VI-22 Annualized PWS Cost Estimates for Corrective Actions based on Level 1 

and Level 2 Assessments ($Millions, 2007$) 

3% discount rate 7% discount rate 

 Corrective Actions based on Level 1 Assessments 

TCR – Total $ - $ - 

AIP – Total 

 $ 

9.17 

 $ 

7.77 

AIP - Net Change 

 $ 

9.17 

 $ 

7.77 

Alternative option - Total 

 $ 

9.39 

 $ 

8.01 
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Alternative option - Net 

Change 

 $ 

9.39 

 $ 

8.01 

 Corrective Actions based on Level 2 Assessments 

TCR – Total $ - $ - 

AIP – Total 

 $ 

2.72 

 $ 

2.41 

AIP - Net Change 

 $ 

2.72 

 $ 

2.41 

Alternative option - Total 

 $ 

3.53 

 $ 

3.36 

Alternative option - Net 

Change 

 $ 

3.53 

 $ 

3.36 

Note: Detail may not add due to independent rounding. 

Source: Proposed RTCR cost model, described in chapter 7 of the Proposed RTCR EA 

(USEPA 2009a). 

The differences in the net change in corrective action costs between the AIP 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 Proposed RTCR EA (USEPA 2009a) and burden hour 

estimates derived from the Draft Information Collection Request for the Public Water System 

Supervision Program (USEPA 2008c). PWS PN unit cost estimates are presented in Exhibit 

7.19 of that document. 

Total and net change in annualized net present value costs for PN 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 

proposed RTCR cost model assumed that all violations are addressed following initial PN, and 

no burden is incurred by PWSs for repeat notification. Annualized total and net cost estimates 

for PWSs and States to perform public notification under the TCR, AIP, and Alternative options 

are presented in Exhibit VI-23. 
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Exhibit VI-23 Annualized National PWS Cost Estimates for Public Notification ($Millions, 

2007$) 

3% discount rate 7% discount rate

TCR - Total $ 3.75 $ 3.60

AIP - Total $ 0.26 $ 0.26

AIP - Net Change $ (3.49) $ (3.35)

AIP - Percent Change -93% -93%

Alternative Option - Total $ 0.34 $ 0.35

Alternative Option - Net Change $ (3.41) $ (3.26)

Alternative Option - Percent Change -91% -90%

Note: Detail may not add due to independent rounding. 

Source: Proposed RTCR cost model, described in chapter 7 of the Proposed 

RTCR EA (USEPA 2009a). 

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 AIP and Alternative options. 

3. State costs 

EPA estimated that all States nationally together incur a net increase in national annualized 

present value costs under the AIP option of $0.1M (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 sampling plans, reviewing sampling results, conducting site 

inspections, reviewing completed assessment forms, tracking corrective actions, and public 

notifications. The following sections summarize the key assumptions that EPA made to estimate 

the costs of the proposed RTCR. Chapter 7 of the Proposed RTCR EA (USEPA 2009a) provides 

a description of the analysis. 

a. Rule implementation and annual administration. States incur administrative costs to 

implement the proposed RTCR. These implementation costs are not directly required by specific 

provisions of the proposed RTCR alternatives, but are necessary for States to ensure the 

provisions of the proposed RTCR are properly carried out. States need to allocate time for their 
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staff to establish and maintain the programs necessary to comply with the proposed 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 Proposed RTCR EA 

(USEPA 2009a) lists the activities required to revise the program following promulgation of the 

proposed RTCR along with their respective costs and burden including, for 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 AIP 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. 

b. Revising sampling plans. Under the AIP and Alternative options, States are expected to 

incur one-time costs to review sampling plans and recommend any revisions to PWSs. Under 

the TCR option, no additional burden or costs are incurred by States to review sampling plans, as 

these PWSs’ sampling plans have already been reviewed and approved. State costs are based on 

the number of PWSs submitting revised sampling plans to PWSs each year. Based on previous 

experience, EPA estimated that States require one to four hours to review revised sampling 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 revising sampling plans of 

$0.42M (three percent discount rate) and $0.59M (seven percent discount rate) under either the 

AIP or the Alternative option. 
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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 current TCR. This estimate reflects the method used to calculate 

reporting and recordkeeping burden under the current 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 TCR 

and both proposed RTCR options, the net change in costs for reviewing monitoring results is 

assumed to be zero for the AIP and Alternative options. Specific actions by States related to 

positive samples are accounted for under the actions required in response to those samples.

d. Site inspections. Under the AIP option, any PWS on an annual monitoring schedule is 

required to also have an annual site inspection conducted by the State or State-designated third 

party. A voluntary Level 2 site assessment can also satisfy the site inspection requirement. In 

many cases a sanitary survey performed during the same year can also be used to satisfy this 

requirement. Although similar site inspections are not currently required under the current TCR, 

discussions with States during the TCRDSAC proceedings revealed that some do, in fact, 

conduct such inspections for PWSs on annual monitoring schedules. Because of the high cost 

for an annual site inspection by a State, for this analysis EPA assumed that no States choose to 

conduct annual site inspections unless they already do so under the current TCR. Under the 

Alternative option, PWSs are required to sample no less than quarterly and under that 

requirement may elect to forgo annual site inspections (especially in cases where the State 

performs or subsidizes the additional monitoring for PWSs that were previously monitoring 

annually) since they are not required. However, due to a lack of data on the potential for 

discontinuing annual site visits under the Alternative option, the proposed RTCR cost model 

does not calculate the potential cost reductions for discontinuing site inspections under the 
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Alternative option. This leads to a potential overestimate of costs for the Alternative option (i.e., 

a cost savings may be realized for some States). For overall costing purposes, no net State or 

PWS costs are assumed for annual monitoring site inspections under the AIP option or 

Alternative option.

e. Assessments. States incur burden to review completed assessment forms required to be 

filed by PWSs under the AIP and Alternative options. Although specific forms are not required 

under the current TCR, EPA assumes that PWSs engage in some form of consultation with the 

State. For costing purposes, EPA assumes that the level of effort required for such consultations 

under the current TCR is the same as that which would be required to review assessment forms 

under the AIP and Alternative options. State costs 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, as well as 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 that 

assessments are done. 

The reduction in the number of assessments under the AIP option compared the current TCR 

(as explained in chapter 7 of the Proposed RTCR EA (USEPA 2009a), based on discussions with 

the technical workgroup supporting the advisory committee, EPA assumes a certain level of 

assessment activity already occurs under the current TCR) is estimated to translate directly to a 

small national cost savings ($0.08M at either three or seven percent discount rate) while the 

increase in the number of assessments under the Alternative option is estimated to translate 

directly to a national cost increase ($0.03M at three percent discount rate and $0.07M at seven 
Document initiating EO 12866 review 

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percent discount rate). Under the AIP, the overall number of assessments decreases as a function 

of reduced occurrence over time. The overall number of assessments is higher under the 

Alternative option as a result of the initial monthly monitoring requirements for all PWSs.

f. Corrective actions. For each corrective action performed under AIP and Alternative 

option, States incur recordkeeping and reporting burden to review 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. The number of 

corrective actions under either the AIP or Alternative 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

g. Public notification. Under the TCR, AIP, 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 AIP 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). Exhibit VI-24 summarizes 

annualized State cost estimates for public notification. 

Exhibit VI-24 Annualized State Cost Estimates for Public Notification ($Millions, 2007$) 
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3% discount rate 7% discount rate

TCR - Total $ 0.44 $ 0.42

AIP - Total $ 0.06 $ 0.06

AIP - Net Change $ (0.38) $ (0.36)

AIP - Percent Change -86% -86%

Alternative Option - Total $ 0.08 $ 0.08

Alternative Option - Net Change $ (0.36) $ (0.34)

Alternative Option - Percent Change -82% -80%

Note: Detail may not add due to independent rounding. 

Source: Proposed RTCR cost model, described in chapter 7 of the Proposed RTCR EA 

(USEPA 2009a). 

4. Nonquantifiable costs 

EPA believes that all of the rule elements that are the major drivers of the net change in 

costs from the current TCR have been quantified to the greatest degree possible. However, 

several items are not specifically accounted for in the cost analysis, and their exclusion from 

consideration may result in an overestimate of net change in cost between the TCR option and 

the AIP option or Alternative option. 

Under the Alternative option, PWSs are required to sample no less often than quarterly. 

Under that requirement, PWSs may elect to forgo annual site inspections (especially in cases 

where the State performs or subsidizes the additional monitoring for PWSs that were previously 

monitoring annually) since the annual inspections are not required. However, due to a lack of 

data on the potential for discontinuing annual site visits under the Alternative option, the 

proposed RTCR cost model does not calculate the potential cost reductions for discontinuing site 

inspections under the Alternative option. This leads to a potential overestimate of costs for the 

Alternative option (i.e., a cost savings may be realized for some States). 

In some instances, the performance of an assessment (especially a Level 2 assessment) may 

overlap with a scheduled sanitary survey. To the extent that the requirements for the State to 

perform a sanitary survey may be satisfied as part of the assessment process, PWSs and States 
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may realize a cost savings compared to performing a separate sanitary survey. This potential for 

indirect cost savings is not captured in the cost model, resulting in a potential overestimate of 

costs stemming from proposed RTCR implementation. 

Under the TCR, AIP, 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 Report (CCR). Because of the use of the CCR to communicate Tier 3 public 

notification on a yearly basis, no cost differential between the current TCR and the AIP 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 proposed 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. 

Resources used to process monitoring violation notices for the CCR (as well as the time spent 

responding to customer inquiries about the notices) may be reduced if significant reductions are 

realized. Exclusion of this potential cost savings may lead to an underestimate of the PN cost 

savings under both the AIP and Alternative option. 

In each of the three cases described previously, the omission in the costing model leads to an 

overestimate of potential costs, resulting in an underestimate of the net cost changes from the 

current TCR. 

Additionally, as an underlying assumption to the costing methodology, EPA assumed that all 

PWSs subject to the proposed RTCR requirements are already complying with the current TCR. 

There may be some PWSs that are not in full compliance with the current TCR, and if so, 

additional costs and benefits are incurred. 
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G. Potential Impact of the Proposed RTCR on Households 

The household cost analysis considers the potential increase in a household’s water bill if a 

CWS passed the entire cost increase resulting from the proposed 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-25 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-25 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-25 presents net costs per household under the AIP and 

Alternative options for all rule components spread across all CWSs. In this scenario, comparison 

to the current TCR shows a cost savings for some households. For those households that are 

expected to see a cost increase, the average annual water bill is expected to increase by less than 

five cents on average. 

While the average increase in annual household water bills to implement the AIP option is 

less than a dollar, customers served by a small CWS that have to take extensive corrective 

actions as a result of the proposed 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 77 percent of households are served by CWSs that perform assessments but do 
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not perform corrective actions over the 25-year period of analysis. These households experience 

a slight cost savings on an annual basis. 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 on average for CWSs serving 4,100 or fewer people on an annual basis. EPA 

estimated that 14 percent of households are served by CWSs that do not perform assessments or 

corrective actions over the 25-year period of analysis. 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 proposed RTCR is corrective actions. 

Exhibit VI-25 Summary of Net Annual Per-Household Costs for the Proposed RTCR 

(2007$) 

3% Discount Rate 7% Discount Rate 

Population 

Served by PWS 

AIP Option Net 

Cost per 

Household 

Alternative 

Option Net Cost 

per Household 

AIP Option Net 

Cost per 

Household 

Alternative 

Option Net Cost 

per Household 

All Community Water Systems (CWSs) 

≤4,100 $0.07 $0.09 $0.10 $0.12

>4,100 $0.05 $0.05 $0.04 $0.04

Total $0.05 $0.06 $0.05 $0.05

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 $(0.02) $(0.01) $(0.01) $(0.01)

Total $(0.02) $(0.01) $(0.01) $(0.01)

Community Water Systems (CWSs) performing Corrective Actions 

≤4,100 $4.11 $4.14 $3.63 $3.68

>4,100 $0.65 $0.65 $0.54 $0.54

Total $0.78 $0.78 $0.66 $0.66

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 $0.00 $0.00 $(0.01) $(0.01)

Total $0.00 $0.01 $0.01 $0.02

Source: Proposed RTCR EA (USEPA 2009a)
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H. Incremental Costs and Benefits 

The proposed RTCR regulatory options achieve increasing levels of benefits at increasing 

levels of costs. The regulatory options for this proposed rule, in order of increasing costs and 

benefits (Option 1 lowest, and option 3 highest) are as follows: 

• Option 1: Current TCR option 

• Option 2: AIP option 

• Option 3: Alternative option 

More information about the options is provided in the Proposed RTCR EA (USEPA 2009a). 

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. Generally, the goal of an incremental analysis is to 

identify the regulatory alternatives where net social benefits are maximized. However, the 

usefulness of this analysis is constrained when major benefits and/or costs are not quantified or 

not monetized as in the case with the proposed RTCR. Also, as pointed out by the 

Environmental Economics Advisory Committee of the Science Advisory Board, efficiency is not 

the only appropriate criterion for social decision making (USEPA 2000a). 

For the proposed RTCR, presentation of incremental quantitative benefit and cost 

comparisons cannot be directly compared because many of the proposed rule’s important 

potential benefits are not quantified, such as the decreased incidence of illness from fecal 

contamination and/or waterborne pathogens including associated outbreaks and death. To 

compare the additional net cost increases and associated incremental benefits of the AIP and the 

Alternative options, benefits are presented in terms of corrective actions performed since 
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performance of corrective actions is expected to have an impact that is most directly translatable 

into potential health benefits. 

Exhibit VI-26 shows the incremental cost of the AIP over the current TCR and the 

Alternative option over the AIP 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 (114 at three percent and 135 and seven percent discount rates) are 

fewer than for the AIP (202 at three percent and 189 at seven percent discount rates), despite the 

increased costs. The relationship between the incremental costs and benefits is examined further 

with respect to cost effectiveness in section VI.M of this preamble. 

Exhibit VI-26 Incremental Net Change in Annualized Present Value Costs ($Millions, 

2007$) and Benefits (Number of Corrective Actions) 

Costs 

Benefits 

(L2 Corrective 

Actions) Regulatory Option 

3% 7% 3% 7% 

Current TCR $ 186.1 $ 178.4 No change No change

AIP $ 199.8 $ 192.5 202 189 

Incremental AIP1 $ 13.7 $ 13.7 202 189 

Alternative $ 213.3 $ 208.5 317 323 

Incremental Alternative2 $ 13.5 $ 16.0 114 135 

1

 Represents the incremental net change of the AIP option over the current TCR option. 

2

 Represents the incremental net change of the Alternative option over the AIP option. Add 

incremental net change for Alternative option to incremental net change for AIP option to calculate 

the total net change of the Alternative option over the current 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 current TCR. The model 

does not incorporate an estimate of the number of corrective actions implemented per year under 

the current TCR and does not yield a total for the AIP and Alternative option that includes the 

current 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 Proposed RTCR EA (USEPA 2009a). 

I. Benefits from Simultaneous Reduction of Co-occurring Contaminants 
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As discussed in section VI.E, the potential benefits from the proposed 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 since 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 these other contaminants. Additional 

health benefits of the proposed RTCR include the reduction in illnesses and deaths associated 

with reduced incidence of upsets or failures from disinfecting operations and reduced incidence 

of distribution system contamination in both disinfecting and non-disinfecting systems. EPA 

anticipates reductions in disease incidence associated with these situations to result from the 

assessment provisions and corrective provisions. 

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 

mitigate a variety of potential contaminants. 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 

It is unlikely that the RTCR results in an increase 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 this rule could impact currently non-disinfecting ground water 

systems. When disinfection is first introduced into a previously undisinfected GW system, 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 
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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 targeted flushing of distribution 

system mains, and by maintaining a proper 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 1998c) 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 (generally represented by total organic carbon (TOC)) that 

contribute to DBP formation. For the most part, ground water systems with high levels of TOC 

in their ground water source are located in States that already require ground water systems to 

disinfect, therefore decreasing the chance that significant disinfection byproduct problems result 

from this proposed rule. 

EPA does not expect many previously undisinfected systems to add disinfection as a result of 

either the AIP or Alternative rule options. See section 7.4.6 of the Proposed RTCR EA (USEPA 

2009a) for a discussion on corrective action.

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

and Sensitive Subpopulations 

As discussed previously in this preamble, fecal contamination may contain waterborne 

pathogens including bacteria, viruses, and parasitic protozoa. 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 
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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). 

 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 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). 

The general population typically experiences acute gastrointestinal illness (some illnesses 

may be severe such as kidney failure) when exposed to fecal contamination and/or waterborne 

pathogens. When sensitive subpopulations experience the same exposure as the general 

population, more severe illness (and sometimes death) can occur. 

Examples of sensitive subpopulations are provided in chapter 2 of the Proposed RTCR EA 

(USEPA 2009a). This section discusses the potential health effects associated with sensitive 

population groups, especially children, pregnant women, and the elderly. 

It is anticipated that the requirements of the proposed 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.
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1. Risk to children, pregnant women, and the elderly 

While bacterial illnesses are not addressed in a quantified benefits analysis as discussed 

previously in this preamble, the nonquantified benefits associated with the proposed RTCR could 

be significant for sensitive subpopulations. Children and the elderly are particularly vulnerable 

to kidney failure (hemolytic uremic syndrome) caused by the pathogenic bacterium E. coli 

O157:H7. Waterborne outbreaks due to E. coli O157:H7 have caused kidney failure in children 

and the elderly as the result of disease outbreaks from 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 2000d). 

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 
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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 2009). 

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 

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 syndrome (kidney failure), the others from 

gastrointestinal illness. 

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 proposed 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, 
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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 

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 proposed 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 Proposed RTCR 

A computer simulation model was used to estimate costs and indicators of benefits of the 

proposed RTCR. Exhibit VI-27 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-27 Simulation Model, Inputs, and Outputs 
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1. Inputs and their uncertainties 

It is anticipated that the requirements of the proposed 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 and chapter 6 of the Proposed RTCR EA (USEPA 2009a) discuss this issue 

qualitatively. 
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Model outputs include two important indicators of microbial exposure: 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-27 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 current 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-27. Results are detailed in the Proposed RTCR EA 

(USEPA 2009a). 

Not shown in Exhibit VI-27 are some inputs that are very well known. These are inventory 

data, which include the list of all PWSs affected by the proposed RTCR and, for each system, 

information on its source water type, disinfection practice, and population served. Although this 
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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 current TCR, AIP, 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 current TCR, AIP, 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 current TCR, AIP, and Alternative options because they influence some options, but 

not others. For example, assumptions about the effectiveness of corrective actions influences 

total costs of the proposed RTCR options, but not the current TCR option itself. 

Results of the sensitivity analyses (reported in the Proposed RTCR EA (USEPA 2009a)) 

showed that the fundamental conclusions of the economic analysis do not change over a wide 

range of assumptions. 

M. Benefit Cost Determination for the Proposed RTCR 
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Pursuant to SDWA section 1412(b)(6)(A), EPA has determined that the benefits of the 

proposed 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. The break-even analysis (see chapter 9 of 

the Proposed RTCR EA (USEPA 2009a)) was conducted using two example pathogens 

responsible for some (unknown) proportion of waterborne illnesses in the United States: shiga 

toxin-producing EC O157:H71

 (STEC O157:H7) and Salmonella. 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 AIP option, just two deaths would 

need to be avoided annually using a 3 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 approach, respectively, would need to be avoided to break even 

with rule costs. As expected based on its costs, the lower cost of the AIP option means that 

fewer cases need to be avoided in order to break even. See Exhibit VI-28. 

As Exhibit VI-28 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 65,000 cases under 

the enhanced and traditional approaches, respectively. Given the large number of potential 

 

1

 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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waterborne pathogens shown to occur in PWSs and the relatively low net costs of the proposed 

RTCR, EPA believes, as discussed in this section and in the Proposed RTCR EA (USEPA 

2009a), that the AIP option is likely to break even. Chapter 9 of the Proposed RTCR EA 

(USEPA 2009a) has a complete discussion of the break-even analysis and how costs per case 

were calculated 

Exhibit VI-28 Estimated Breakeven Threshold for Avoided Cases of E. coli O157:H7 and 

Salmonella

Cost of Illness AIP Option Alternative Option 

(COI) 

Methodology 

Discount 

Rate Non-fatal 

cases only 

Fatal cases 

only1

Non-fatal 

cases only 

Fatal cases 

only1

E. coli O157:H7 

3% 8,000 1.6 16,000 3.1

Traditional COI 7% 8,000 1.5 17,000 3.4

3% 3,000 1.6 5,000 3.1

Enhanced COI 7% 3,000 1.5 6,000 3.4

Salmonella 

3% 65,000 1.6 130,000 3.1

Traditional COI 7% 65,000 1.6 141,000 3.4

3% 10,000 1.6 20,000 3.1

Enhanced COI 7% 10,000 1.6 21,000 3.4

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 proposed 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. 

Differences in the three percent and seven percent estimates among the AIP and Alternative 

Analysis can be explained by how costs accrue over the period of analysis. Cost for the AIP are 

relatively consistent across the period of analysis while greater costs for the Alternative occur 

early in the rule implementation period due to increases in monitoring and corrective actions. 

Cost-effectiveness is another way of examining the benefits and costs of the proposed rule. 

Exhibit VI-29 shows the cost of the rule per corrective action avoided. The cost-effectiveness 
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analysis, as with the net benefits, is limited because EPA was able to only partially quantify and 

monetize the benefits of the proposed RTCR. As discussed previously and demonstrated in the 

Proposed RTCR EA (USEPA 2009a), the proposed rule, i.e., the AIP option, achieves the lowest 

cost per corrective action avoided among the options considered. The incremental costeffectiveness analysis shows that the AIP has a lower cost per corrective action than the 

Alternative option. 

Exhibit VI-29 Total Net Annual Cost Per Corrective Action (CA) Implemented under AIP 

and Alternative Options, Annualized (using three percent and seven percent 

discount rates) ($2007) 

Regulatory Scenario 3% Discount Rate 7% Discount Rate

AIP Net Cost ($ Millions) $ 13.7 $ 13.7 

AIP Net Corrective Actions (L1 & L2) 598 555 

AIP Cost Effectiveness Analysis (CEA )(net rule cost/CA) $ 22,899 $ 24,610 

Alternative Option Net Cost $ 27.2 $ 29.7 

Alternative Option Net Corrective Actions (L1 & L2) 785 765 

Alternative Option CEA (net rule cost/CA) $ 34,718 $ 39,812 

Note: Corrective actions include those conducted as a result either Level 1 or Level 2 assessments. 

Total rule costs are shown in Exhibit 9.14 of the Proposed RTCR EA (USEPA 2009a). Detailed 

benefits and cost information is provided in Appendices A and C, respectively, of the Proposed RTCR 

EA (USEPA 2009a). 

EPA also considered the incremental cost-effectiveness of the AIP option as compared to the 

Alternative option to determine the additional benefit associated with the portion of cost for the 

Alternative option that exceeds the cost of the AIP option. Exhibit VI-30 shows that in 

incremental terms for all PWSs, the AIP option has a far lower unit cost per unit benefit 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 proposed RTCR because of the number 

of systems in the group, but the per cost system of this group is relatively low, ($83 annualized at 

3% discount in 2007$). The two incremental analyses (Exhibit VI-30 and Exhibit VI-31) 
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together indicate that, using a three percent discount rate to compare incremental benefits and 

costs, the AIP 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 Proposed RTCR EA 

(USEPA 2009a). 

Exhibit VI-30 Incremental Rule Cost Per Corrective Action (CA) Implemented under AIP 

and Alternative Options, Annualized (using three percent and seven percent 

discount rates) ($2007) 

Regulatory Scenario 3% Discount Rate 7% Discount Rate 

A. AIP Incremental Net Costs ($ millions) 1 $ 

13.7 

 $ 

13.7 

B. AIP Incremental Net Corrective Actions (L1 & 

L2) 1 598 555

C. AIP Incremental Cost per CA ($) (C = A/B) $ 

22,899 

 $ 

24,610 

D. Alternative Option Incremental Net Costs ($ 

millions) 2

 $ 

13.5 

 $ 

16.0 

E. Alternative Option Incremental Net Corrective 

Actions (L1 & L2) 2 187 210

F. Alternative Option Incremental Cost per 

CA ($) (F = D/E) 

 $ 

72,582 

 $ 

76,299 

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 current 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 Proposed RTCR EA 

(USEPA 2009a). Detailed benefits and cost information is provided in Appendices A and C, 

respectively, of the Proposed RTCR EA (USEPA 2009a). 

1

Represents the incremental increase of the AIP option over the current TCR. 

2

Represents the incremental increase of the Alternative option over AIP option. Add 

incremental net values for Alternative option to incremental net values for AIP option to 

calculate total net values of Alternative option over current TCR. 

Exhibit VI-31 Incremental Rule Cost Per Corrective Action (CA) for TNCWSs using GW 

Implemented under AIP and Alternative Options, Annualized (using three percent 

and seven percent discount rates) ($2007) 
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Regulatory Scenario 3% Discount Rate 7% Discount R

1. AIP Incremental Net Costs ($ millions)1 $ 5.1 $ 

2. AIP Incremental Corrective Actions (L1 & L2) (TNCWS <101 only)1 279 

3. AIP Incremental Cost per CA ($) $ 18,219 $ 19,

4. Alternative Option Incremental Net Costs ($ millions)2 $ 8.3 $ 

5. Alternative Option Incremental Corrective Actions (L1 & L2) 

(TNCWS <101 only)2 128 

6. Alternative Option Incremental Cost per CA ($) $ 64,731 $ 67, 1

Represents the incremental increase of the AIP option over the current TCR. 

2

Represents the incremental increase of the Alternative option over AIP option. Add incremental net values for 

Alternative option to incremental net values for AIP option to calculate total net values of Alternative option ove

current 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 Proposed RTCR EA (USEPA 2009a). 

The preferred option for the proposed RTCR is the AIP option. The analyses performed as 

part of the Proposed RTCR EA (USEPA 2009a) support the collective judgment and consensus 

of the advisory committee that the AIP requirements provide for effective and efficient revisions 

to the current TCR regulatory requirements. The estimated net cost of the AIP option is small 

($14M annually) as compared to the current TCR and small compared to the net cost of the 

Alternative option ($27M – $30M) as compared with the current TCR. In addition, the net 

benefits are expected to be positive under the AIP option and no backsliding in overall risk is 

predicted. While the number of corrective actions under the Alternative option is greater than 

under the AIP option, the achievement of these benefits is not as cost effective as under the AIP 

option. 

EPA's Proposed RTCR EA (USEPA 2009a) shows that additional monitoring is likely to lead 

to more corrective actions under the Alternative option than under either the current TCR option 

or the AIP option but with significant increase in costs, especially for small systems. EPA 

concluded that the increased costs associated with the Alternative option did not justify the 

increased benefits because under the AIP option, States could trade off monitoring for system 
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site visits due to limited State resources. In particular, the cost-effectiveness analysis shows that 

the Alternative option is not as cost-effective as the proposed AIP option. 

N. Request for Comment 

EPA requests comment on its assessment of the benefit-cost determination conclusion.

VII. Statutory and Executive Order Review 

A. Executive Order 12866: Regulatory Planning and Review 

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is a “significant 

regulatory action” because it raises novel legal or policy issues arising out of legal mandates, the 

President’s priorities, or the principles set forth in the Executive Order. Accordingly, EPA 

submitted this action to the Office of Management and Budget (OMB) for review under 

Executive Order 12866 and any changes made in response to OMB recommendations have been 

documented in the docket for this action. 

EPA estimates that the proposed RTCR will have an overall impact on public water systems 

of $14 M and that the impact on small entities (PWSs serving 10,000 people or fewer) will be 

$9.4 M - $9.8 M annualized at 3 and 7 percent discount rates, respectively. These impacts are 

described in sections VI and VII.C of this preamble, respectively, and in the analysis that EPA 

prepared of the potential costs and benefits of this action, contained in the Proposed RTCR EA 

(USEPA 2009a) 

B. Paperwork Reduction Act 

The information collection requirements for the proposed RTCR have been submitted for 

approval to the OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The 

Information Collection Request (ICR) document prepared by EPA has been assigned EPA ICR 

number 1895.06. 
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 The Paperwork Reduction Act requires EPA to estimate the burden on public water systems 

(PWSs) and State/primacy Agencies of complying with the rule. The information collected as a 

result of EPA’s efforts toward proposing the proposed RTCR should 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 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 sampling plans and recommend any revisions to PWSs; 

• Make determinations concerning PWS monitoring requirements; 

• Respond to PWSs with 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 

• Provide consultation, review public notification certifications, and file reports of violations. 
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PWS activities: 

• Read and understand the rule; 

• Planning and mobilization activities; 

• Revise existing sampling plans to identify sampling locations and collection schedules that 

are representative of water throughout the distribution system; 

• Conduct routine, additional routine, and repeat monitoring; 

• Complete a Level 1 Assessment if the PWS experiences a Level 1 trigger, and submit a 

timetable 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 

timetable for any corrective actions not already completed; 

• Correct sanitary defects found through the performance of Level 1 or Level 2 assessments; 

• Develop and distribute Tier 1 public notices when E. coli MCL violations occur; 

• Develop and distribute Tier 2 public notices when the PWSs failed to take corrective action; 

and 

• Develop and distribute Tier 3 public notices when the PWSs failed to comply with the 

monitoring requirements or with mandatory reporting of required information within the 

specified timeframe. 

For the first three years after publication of the final rule in the Federal Register, 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 current TCR to those in the 

proposed RTCR over the three years covered by the ICR is 2,518,878 hours, for an average 

of 839,526 hours per year. The total incremental cost over the three year clearance period is 
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$71.3 million, for an average of $23.8 million per year (simple average over three years). 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 $153.4. The collection 

requirements are mandatory under SDWA (42 U.S.C. 300h et seq.). Detail on the calculation of 

the proposed rule information collection burden and costs can be found in the Information 

Collection Request for the Proposed Revised Total Coliform Rule (USEPA 2009d) and chapter 7 

of the EA (USEPA 2009a). A summary of the burdens and costs of the proposed collection is 

presented in Exhibit VII-1. 

Exhibit VII-1 Average Annual Net Change Burden and Costs for the Proposed RTCR ICR 

Respondent Cost 

Type 

Annual 

Burden 

Hours 

Annual 

Labor Cost 

Annual 

Operation & 

Maintenance 

(O&M) Cost

Annual 

Capital 

Cost 

Total 

Annual 

Cost 

Annual 

Responses

PWSs 747,848 $20,171,639 $0 $0 $20,171,639 103,225 

States and 

Territories 

91,678 $3,595,421 $0 $0 $3,595,421 51,669 

Total 839,526 $23,767,060 $0 $0 $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 Request for the Proposed Revised Total Coliform Rule (USEPA 

2009d) 

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. To comment on 

EPA’s need for this information, the accuracy of the provided burden estimates, and any 

suggested methods for minimizing respondent burden, EPA has established a public docket for 

this proposed rule, which includes this ICR, under Docket ID number EPA-HQ-OW-2008-0878. 

Submit any comments related to the ICR to EPA and OMB. See ADDRESSES section at the 
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beginning of this notice for where to submit comments to EPA. Send comments to OMB at the 

Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th 

Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Since OMB is required 

to make a decision concerning the ICR between 30 and 60 days after [INSERT DATE OF 

PUBLICATION IN THE FEDERAL REGISTER], a comment to OMB is best assured of 

having its full effect if OMB receives it by [INSERT DATE 30 DAYS AFTER 

PUBLICATION IN THE FEDERAL REGISTER]. The final rule will respond to any OMB 

or public comments on the information collection requirements contained in this proposal. 

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 Register and taking comment. 
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5 USC 601(3) - (5). In addition, to establish an alternative small business definition, agencies 

must consult with SBA’s Chief Counsel for Advocacy. 

For purposes of assessing the impacts of the proposed RTCR on small entities, EPA 

considered small entities to be PWSs serving fewer than 10,000 people. This is the cut-off level 

specified by Congress in the 1996 Amendments to the Safe Drinking Water Act for small system 

flexibility provisions. As required by the RFA, EPA proposed using this alternative definition in 

the Federal Register (63 FR 7620, February 13, 1998), requested public comment, consulted 

with the SBA, and finalized the alternative definition in the Consumer Confidence Reports 

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 today’s proposed rule 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 proposed rule are small PWSs serving fewer 

than 10,000 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 Proposed RTCR EA (USEPA 2009a). 

Although this proposed 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 
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PWSs. Provisions in the proposed RTCR that result in reduced costs for many small entities 

include: 

• Reduced routine monitoring for qualifying PWS serving 1,000 or fewer people. 

• Reduced number of repeat samples required. 

• Reduced additional routine monitoring for PWS serving 4,100 or fewer people. 

• Reduced public notification requirements for all systems, including small systems. 

• Reductions in corrective actions over time as a result of enhanced system performance for all 

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 the proposed rule's requirements. EPA consulted with small 

entity representatives before and during the review by the Panel. These small entity 

representatives included representatives from small water systems of various types and sizes, 

representatives from associations that assist and /or advocate for small systems, and Federal 

agencies that operate small systems. Panel members included representatives from OMB, the 

Small Business Administration, and the EPA Office of Ground Water and Drinking Water. The 

consultation led to the development of a report providing recommendations to EPA on how to 

revise the TCR to address small system concerns, which EPA considered in drafting this 

proposed RTCR (SBAR Panel 2008). EPA also made presentations to the advisory committee 

on the recommendations of the Panel so the advisory committee could consider their 

recommendations in developing the AIP. 

Consistent with the RFA/Small Business Regulatory Enforcement Fairness Act (SBREFA) 

requirements, the Panel evaluated the assembled materials and small-entity comments on issues 
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and prepared a final report to the EPA Administrator. A copy of the Panel report is included in 

the docket for this proposed rule. The proposed rule is consistent with the Panel 

recommendations to use total coliforms as a trigger for investigation and/or corrective action, to 

balance monitoring requirements and costs with risk, to further differentiate requirements based 

on differences in water systems, to coordinate requirements with other related rules, and to 

consider reporting and recordkeeping costs in estimating burden. Consistent with the Panel 

recommendation to evaluate which parameters are most appropriate for routine monitoring and 

as potential triggers for investigative and corrective actions, EPA is conducting a review of 

existing methods for total coliform and E. coli analysis and is evaluating its Alternative Test 

Procedure protocol for approving new methods as described in section III.9 of this preamble. 

EPA is also one of the founding members of a Research and Information Collection Partnership, 

described in section V of this preamble, which is considering research and information needs to 

evaluate the magnitude of risks and potential risk mitigation options related to potential 

distribution system contamination. 

We continue to be interested in the potential impacts of the proposed rule on small entities 

and welcome comments on issues related to such impacts. 

D. Unfunded Mandates Reform Act (UMRA) 

This proposed rule does not contain a Federal mandate that may result in expenditures to 

State, local, and Tribal governments, in the aggregate, or to the private sector, of $100 million or 

more in any one year. Expenditures associated with compliance, defined as the incremental costs 

beyond the current TCR, will not surpass $100 million in the aggregate in any year. Thus, this 

proposed rule is not subject to the requirements of sections 202 and 205 of UMRA. 
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This proposed rule 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 not significant, as described previously in section VII.C 

and are detailed in the Proposed RTCR EA (2009a). The regulatory requirements of the 

proposed 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 

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 $0.1M and $0.4M at three percent and seven percent 

discount rates, respectively. Thus, Executive Order 13132 does not apply to this proposed rule. 

Although section 6 of Executive Order 13132 does not apply to the proposed 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 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 RTCR were developed. 
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In the spirit of Executive Order 13132, and consistent with EPA policy to promote 

communications between EPA and State and local governments, EPA specifically solicits 

comment on this proposed action from State and local officials. 

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). Thus, Executive Order 13175 does not apply to this action 

Although Executive Order 13175 does not apply to this action, EPA consulted with Tribal 

officials in developing this action. EPA has consulted with Tribal governments through the EPA 

American Indian Environmental Office, included a representative of the Native American Water 

Association on the advisory committee which developed recommendations regarding the 

proposed rule and signed the AIP, and has 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 current TCR, requested suggestions for current TCR revisions (March 2008), and 

presented possible revisions to the current TCR to the National Tribal Council (April 2008). In 

addition, the advisory committee included entities representing Tribal governments, and through 

this process EPA ensured that their views were considered when the AIP recommendations for 

the RTCR were developed. None of these consultations identified issues that were particular to 

Tribal entities. As a result of the Tribal consultations and other Tribal outreach, EPA has 

determined that the proposed RTCR is not anticipated to have a negative impact on Tribal 

systems. Thus, Executive Order 13175 does not apply to this action. 

EPA specifically solicits additional comment on this proposed action from Tribal officials. 
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G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety 

Risks 

The proposed 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 are contained in 

section VI of this preamble and in the Proposed RTCR EA (USEPA 2009a). EPA expects that 

the proposed RTCR would provide additional protection to both children and adults who 

consume drinking water supplied from PWSs. EPA also believes that the benefits of the 

proposed 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. 

The public is invited to submit comments or identify peer-reviewed studies and data that 

assess effects of early life exposure to drinking water that contains fecal contaminants. 

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

Use 

The proposed RTCR 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, distribution, or use of energy. Additionally, none of the proposed RTCR requirements 

involve the installation of treatment or other components that use a measurable amount of 

energy. 
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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. 

The proposed RTCR involves technical voluntary consensus standards. EPA proposes 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 proposed rule includes 11 methods that can be used to test for total coliforms. 

Four of the 11 are described in Standard Methods. 

EPA welcomes comments on this aspect of the proposed rulemaking and, specifically, invites 

the public to identify potentially-applicable voluntary consensus standards and to explain why 

such standards should be used in this regulation. 

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 States. 

EPA has determined that this proposed rule 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 proposed RTCR applies uniformly to all 

PWSs. Consequently, the proposed RTCR provides health protection equally to all income and 

minority groups served by PWSs. The proposed 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 low-income populations (which is unknown), the 

proposed 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 proposed 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 proposed RTCR. 
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EPA met with the Drinking Water Committee of the SAB to discuss the proposed RTCR on 

May 20, 2009 (teleconference) and June 9 and 10, 2009 (Washington, DC). The SAB 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 States; (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. 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 additional analyses, 

added exhibits, and expanded and clarified the text of the Proposed RTCR EA (USEPA 2009a) 

to make the analysis more transparent, robust, and easier to read. A copy of the SAB report 

(SAB 2009) is available in the docket for the proposed RTCR. 

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. Education was a common theme in the responses from NDWAC members. Some 

members recommended that EPA provide the utilities and States with tools to help them 
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understand the revised rule provisions and to assist with providing public education. A few 

members stated that they would like to provide EPA with additional advice on public 

notification. In response to NDWAC’s concern, EPA is requesting comment on whether the 

proposed RTCR would result in requirements that would be easier to implement compared to the 

current TCR. 

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 is requesting comment on the cost and benefit of reduced monitoring. 

A few NDWAC members stated that they would like to provide EPA with additional advice 

on public notification. To follow up on this request, EPA met with several NDWAC members 

on July 1, 2009, to review and discuss the current TCR public notification requirements, the 

advisory committee's recommendations on revisions to the public notification requirements, and 

to obtain feedback from NDWAC members. At this meeting, NDWAC members discussed 

potential changes to health effects language. They noted that while some portions of the health 

effects language would still be appropriate under the proposed RTCR, some changes or additions 

may be appropriate. Potential inclusions include the use of two different types of Tier 2 public 

notice to account for the difference between failure to conduct assessments and failure to 

complete corrective actions, as well as language concerning customer actions in response to 

violations (such as boiling water before use), and a change in the description of health effects of 

coliform exposure by sensitive subpopulations. They also recommended that EPA look at the 
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public notification requirements for the GWR as they may also be appropriate for the proposed 

RTCR. 

EPA completed its consultation with the US Department of Health and Human Services on 

October 5, 2009, as required by SDWA section 1412(d). EPA also provided an informational 

briefing to the Food and Safety Group of the Food and Drug Administration. 

L. Impacts on Sensitive Subpopulations as Required by Section 1412(b)(3)(C)(i) of the 1996 

Amendments of the Safe Drinking Water Act (SDWA) 

EPA is required to seek 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. 
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Immunocompromised individuals are a growing proportion of the population with the 

continued increase in HIV/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. 

It is anticipated that the requirements of the proposed 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 proposed 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. 

M. Plain Language 

Executive Order 12866 requires each agency to write its rules in plain language. Readable 

regulations help the public find requirements quickly and understand them easily. Readable 

regulations may also increase compliance, strengthen enforcement, and decrease mistakes, 

frustration, phone calls, appeals, and distrust of government. EPA has made every effort to write 

this preamble to the proposed rule in as clear, concise, and unambiguous manner as possible. 

EPA requests comments on how to improve rule language to enhance readability and make it 

easier to understand. 

VIII. References 

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SBAR Panel (Small Business Advocacy Review Panel). 2008. Small Business Advocacy Review 

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bloody diarrhea and death. Annals of Internal Medicine. 117(10):812B819. 

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27486. (June 29, 1989). 
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USEPA. 1998a. National Primary Drinking Water Regulations: Stage 1 Disinfectants and 

Disinfection Byproducts; Final Rule. 63 FR 69389. (December 16, 1998). 

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USEPA. 2000d. Health Risks of Enteric Viral Infections in Children. Office of Science and 

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USEPA. 2006d. National Primary Drinking Water Regulations: Long Term 2 Enhanced Surface 

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USEPA 2009a. Economic Analysis for the Proposed Revised Total Coliform Rule. EPA-815-XXX-XXX. 

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Regulations: Proposed Revised Total Coliform Rule. EPA-815-X-XX-XXX. 

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Final Rule. 74 FR 53590. (October 19, 2009). 

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Distribution System Research and Information Collection Partnership Between the US 

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Quality and Human Health. Edited by Cotruvo, J.V., M. Exner, C. Fricker, and A. Glasmacher. 

IWA Publishing, London. pp.199-232. 

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Water by a Colorimetric â-Galactosidase Assay. Applied and Environmental Microbiology 

35(1):136-141). 

Title: National Primary Drinking Water Regulation: Revisions to the Total Coliform Rule 

Rule p. xxx of xxx

List of Subjects 

40 CFR Part 141 

Environmental protection, Chemicals, Indian-lands, Intergovernmental relations, Radiation 

protection, Reporting and recordkeeping requirements, Water supply. 

40 CFR Part 142 

 Environmental protection, Administrative practice and procedure, Chemicals, Indianlands, Radiation protection, Reporting and recordkeeping requirements, Water supply. 

Dated: ________________________________ 
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______________________________________ 

Lisa P. Jackson, 

Administrator 

For the reasons set forth in the preamble, Title 40 chapter 1 of the Code of Federal Regulations is 

proposed to be amended as follows: 

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 141.4 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 
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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 [INSERT DATE THREE YEARS 

FOLLOWING PUBLICATION OF THE FINAL RULE], at which time the total coliform 

MCL is no longer effective. 

 3. Section 141.13 is removed and reserved. 

 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 [INSERT DATE THREE 

YEARS FOLLOWING 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 [INSERT DATE THREE YEARS FOLLOWING 

PUBLICATION OF THE FINAL RULE] is completed, as well as analytical method, 
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reporting, recordkeeping, public notification, and consumer confidence report requirements 

associated with that monitoring and testing. After [INSERT DATE THREE YEARS 

FOLLOWING 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 frequency required on [INSERT DATE THREE YEARS FOLLOWING PUBLICATION 

OF THE FINAL RULE]. 

 5. Section 141.22 is removed and reserved. 

 6. 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
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 (b) The MCLG identified in paragraph (a)(4) is applicable until [INSERT DATE THREE 

YEARS FOLLOWING PUBLICATION OF THE FINAL RULE]. The MCLG identified in 

paragraph (a)(6) is applicable beginning [INSERT DATE THREE YEARS FOLLOWING 

PUBLICATION OF THE FINAL RULE]. 

 7. Section 141.63 is revised to read as follows: 

§ 141.63 Maximum contaminant levels (MCLs) for microbiological contaminants. 

(a) Until [INSERT DATE THREE YEARS FOLLOWING 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 [INSERT DATE THREE YEARS FOLLOWING 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. 
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(c) Beginning [INSERT DATE THREE YEARS FOLLOWING 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. 

(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 [INSERT DATE THREE YEARS FOLLOWING 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 [INSERT DATE THREE YEARS FOLLOWING 

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; 
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(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; 

(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. 

 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 [INSERT DATE THREE YEARS FOLLOWING 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 [INSERT DATE THREE YEARS FOLLOWING 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 141.857. 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 
Document initiating EO 12866 review 

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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) 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, 

and as specified in §§ 141.854 through 141.857 beginning [INSERT DATE THREE YEARS 

FOLLOWING PUBLICATION OF THE FINAL RULE], except that 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. 

***** 
Document initiating EO 12866 review 

230 

(c) *** 

(1) *** 

(i) Routine monitoring. Until [INSERT DATE THREE YEARS FOLLOWING 

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 [INSERT DATE THREE YEARS 

FOLLOWING PUBLICATION OF THE FINAL RULE], community and non-transient noncommunity 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 141.857. Subpart H 

systems 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 by revising the introductory text to paragraph (d)(4)(vii), 

revising paragraph (d)(4)(viii), and adding paragraphs (d)(4)(x) and (d)(4)(xi) to read as follows: 

§ 141.153 Content of the reports. 

***** 

(d) *** 

(4) *** 
Document initiating EO 12866 review 

231 

(vii) For total coliform analytical results until [INSERT DATE THREE YEARS 

FOLLOWING PUBLICATION OF THE FINAL RULE]: 

***** 

(viii) For fecal coliform until [INSERT DATE THREE YEARS FOLLOWING 

PUBLICATION OF THE FINAL RULE]: The total number of positive samples; 

***** 

(x) For total coliform taken under subpart Y: 

(A) The number of Level 1 and Level 2 assessments required and completed; and 

(B) The corrective actions required and completed; and 

(xi) For E. coli: The total number of positive samples. 

***** 

 11. In subpart O, Appendix A, the table is amended by revising the entries for “Total Coliform 

Bacteria” and “Fecal Coliform and E. coli,” adding a second entry for “Total Coliform Bacteria,” 

adding as a fourth entry “E. coli,” and adding two endnotes, to read as follows: 

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 

........ MCL 

(systems 

that 

collect 

 0 Naturally 

present in the 

environment 

Coliforms are 

bacteria that are 

naturally present in 

the environment and 
Document initiating EO 12866 review 

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samples are 

positive; 

(systems that 

collect <40 

samples/month) 

1 positive 

monthly sample 

≥40 

samples/

month) 

5% of 

monthly 

samples 

are 

positive; 

(systems 

that 

collect 

<40 

samples/

month) 

1 

positive 

monthly 

sample.

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 

Coliforms are 

bacteria that are 

naturally present in 

the environment and 

are used as an 

indicator that other, 

potentially harmful, 

bacteria may be 

present. The water 

system found 

coliforms indicating 

the need to look for 

potential problems in 

water treatment or 

distribution. When 

this occurs, public 

water systems are 

required to conduct 

assessments to 

identify problems 

and to correct any 

problems that are 

found. 

[THE SYSTEM 

MUST USE THE 

FOLLOWING 

APPLICABLE 
Document initiating EO 12866 review 

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SENTENCES.] 

The water system 

failed to conduct the 

required 

assessment(s). 

The water system 

failed to correct all 

identified sanitary 

defects. 

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 

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 

...... In 

complia

nce 

unless 

one of 

the 

followin

g 

conditio

ns 

occurs: 

(1) The 

system 

has an 

 0 Human and 

animal fecal 

waste 

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 
Document initiating EO 12866 review 

234 

to analyze total 

coliformpositive repeat 

sample for E. 

coli

E. coli-

positive 

repeat 

sample 

followin

g a total 

coliform

-positive 

routine 

sample. 

(2) The 

system 

has a 

total 

coliform

-positive 

repeat 

sample 

followin

g an E. 

coli-

positive 

routine 

sample. 

(3) The 

system 

fails to 

take all 

required 

repeat 

samples 

followin

g an E. 

coli-

positive 

routine 

sample. 

(4) The 

system 

fails to 

test for 

E. coli

when 

any 

repeat 

sample 

greater health risk for 

infants, young 

children, some of the 

elderly, and people 

with severelycompromised 

immune systems. 
Document initiating EO 12866 review 

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tests 

positive 

for total 

coliform

.

* * * * * * * 

***** 

† Until [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE 

FINAL RULE].

‡ Beginning [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE 

FINAL RULE]. 

***** 

 12. Section 141.202(a), Table 1, is amended by redesignating entry (1) as entry (1)(i) and 

adding entry (1)(ii) 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)(i) Violation of the MCL for total coliforms when fecal coliform or E. coli are present in the 

water distribution system (as specified in § 141.63(b)), or when the water system fails to test for 

fecal coliforms or E. coli when any repeat sample tests positive for coliform (as specified in § 

141.21(e)); 

(1)(ii) 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 

***** 

(b) *** 
Document initiating EO 12866 review 

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(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 

(6) Reporting violations under subpart Y of 40 CFR part 141. 
Document initiating EO 12866 review 

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***** 

 15. Appendix A to subpart Q is amended by redesignating and revising entries I.A.1 as I.A.1.a 

and I.A.2 as I.A.2.a, adding new entries I.A.1.b and I.A.2.b, and adding two endnotes to read as 

follows: 

APPENDIX A TO SUBPART Q OF PART 141 – NPDWR VIOLATIONS AND OTHER 

SITUATIONS REQUIRING PUBLIC NOTICE1

MCL/MRDL/TT 

violations2

Monitoring, testing & 

reporting procedure 

violations 

Contaminant 

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 (TT violations 

resulting from failure to perform 

assessments or corrective actions) ‡ 

2 141.860(b) 3 141.860(c)

2.a Fecal coliform/E. coli † 1 141.63(b) 1,3 141.21(e)

2.b E. coli ‡ 1 141.63(c) 3 141.860(d)(2)

* * * * * * * 

Appendix A—Endnotes 

† Until [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE 

FINAL RULE].

‡ Beginning [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE 

FINAL RULE]. 

***** 
Document initiating EO 12866 review 

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 16. Appendix B to subpart Q is amended by revising entries 1a and 1b, adding entries 1e and 1f, 

and adding two endnotes to read as follows: 

APPENDIX B TO SUBPART Q OF PART 141 – STANDARDS HEALTH EFFECTS 

LANGUAGE FOR PUBLIC NOTIFICATION

Contaminant MCLG1

mg/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, bacteria may be present. The 

water system found coliforms indicating 

the need to look for potential problems in 

water treatment or distribution. When this 

occurs, public water systems are required 

to conduct assessments to identify 

problems and to correct any problems that 

are found. 

[THE SYSTEM MUST USE THE 
Document initiating EO 12866 review 

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FOLLOWING APPLICABLE 

SENTENCES.] 

The water system failed to conduct the 

required assessment. 

The water system failed to correct all 

identified sanitary defects. 

1f. 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 

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. 

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 greater 

health risk for infants, young children, 

some of the elderly, and people with 

severely compromised immune systems. 

 * * * * * * * 

Appendix B—Endnotes 

† Until [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE 

FINAL RULE]

‡ Beginning [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE 

FINAL RULE] 
Document initiating EO 12866 review 

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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 [INSERT DATE THREE YEARS 

FOLLOWING 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 beginning [INSERT DATE 

THREE YEARS FOLLOWING 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 [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL 

RULE], or collected under §§ 141.854 through 141.857 beginning [INSERT DATE THREE 

YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], except as provided in 

paragraph (a)(2)(ii) of this section. 
Document initiating EO 12866 review 

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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 [INSERT DATE 

THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], or under § 

141.853 beginning [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF 

THE FINAL RULE], and that the system intends to use for representative sampling under this 

paragraph. 

(iii) Until [INSERT DATE THREE YEARS FOLLOWING 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 [INSERT DATE THREE YEARS FOLLOWING 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 
Document initiating EO 12866 review 

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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 [INSERT DATE 

THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], or under §§ 

141.854 through 141.857 beginning [INSERT DATE THREE YEARS FOLLOWING 

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 [INSERT DATE THREE YEARS 

FOLLOWING PUBLICATION OF THE FINAL RULE], or collected under §§ 141.854 
Document initiating EO 12866 review 

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through 141.857 beginning [INSERT DATE THREE YEARS FOLLOWING 

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 [INSERT DATE THREE YEARS FOLLOWING 

PUBLICATION OF THE FINAL RULE], or under §§ 141.854 through 141.857 beginning 

[INSERT DATE THREE YEARS FOLLOWING 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 [INSERT DATE 

THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], or under §§ 

141.854 through 141.857 beginning [INSERT DATE THREE YEARS FOLLOWING 

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. 

***** 
Document initiating EO 12866 review 

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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 [INSERT DATE 

THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], or under § 

141.853 beginning [INSERT DATE THREE YEARS FOLLOWING 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 [INSERT DATE 

THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], and under § 

141.852 beginning [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF 

THE FINAL RULE]. 

 ***** 

 (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 
Document initiating EO 12866 review 

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§ 141.21(c)(2) until [INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF 

THE FINAL RULE], or in accordance with § 141.853(c) beginning [INSERT DATE THREE 

YEARS FOLLOWING 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. 

141.850 General. 

141.851 Definitions. 

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 serving 1,000 or 

fewer people. 

141.857 Routine monitoring requirements for public water systems serving more than 1,000 

people. 
Document initiating EO 12866 review 

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141.858 Repeat monitoring and E. coli requirements. 

141.859 Coliform treatment technique requirements for protection against potential fecal 

contamination. 

141.860 Violations. 

141.861 Reporting and recordkeeping. 

Subpart Y - Revised Total Coliform Rule 

§ 141.850 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 

[INSERT DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL 

RULE], unless otherwise specified in this subpart. 

§ 141.851 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 treatment technique 

trigger exceedances or treatment technique violations under subpart Y. 

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. 
Document initiating EO 12866 review 

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Seasonal system is a non-community water system that is operated three or fewer calendar 

quarters per calendar year. 

§ 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 of either 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 chlorinated water 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 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 

Method1

 Citation 

Total Coliforms 

Total Coliform Multiple 

Tube Fermentation 

Technique 

9221 B.1, B.2 1, 2 Lactose 

Fermentation 

Methods 

Presence-Absence (P-A) 

Coliform Test 

9221 D.1, D.2 1, 12

 
Document initiating EO 12866 review 

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Total Coliform Membrane 

Filter Technique 

9222 B, C 1, 3

Membrane Filtration using 

MI medium 

EPA Method 1604 3, 4

Membrane 

Filtration 

Methods 

m-ColiBlue24® Test 3, 5 

 Chromocult 3, 6 

 

Colilert® 9223 B 1, 7

Colisure® 9223 B 1, 7, 8

E*Colite® Test 9 

Readycult® Test 10 

Enzyme Substrate 

Methods 

modified Colitag® Test 11 

 

Escherichia coli

Escherichia coli

Procedure 

(following Lactose 

Fermentation 

Methods) 

EC-MUG medium 9221 F.1 1

 

Escherichia coli 

Partition Method 

EC broth with MUG (ECMUG) 9222 G.1a(2)1, 13

 NA-MUG medium 9222 G.1a(1)1

 

Membrane Filtration using 

MI medium 

EPA Method 1604 3, 4 Membrane 

Filtration Methods 

m-ColiBlue24® Test 3, 5 

 Chromocult 3, 6 

 

Colilert® 9223 1, 7

Colisure® 9223 1, 7, 8

E*Colite® Test 9 

Readycult® Test 10 

Enzyme Substrate 

Methods 

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. 
Document initiating EO 12866 review 

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Copies of the documents may be obtained from the sources listed below. Information 

regarding these documents can be obtained from the Safe Drinking Water Hotline, 

telephone (800) 426-4791. Documents may be reviewed at EPA's Drinking Water 

Docket, EPA West, 1301 Constitution Avenue, NW, EPA West, Room B102, 

Washington, DC 20460 (Telephone: 202-566-2426); or at the National Archives and 

Records Administration (NARA). For information on the availability of this material at 

NARA, call (202) 741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibrlocations.html.

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. In addition, the following online versions may 

also be used: 9221 B.1, B.2-99, D.1, D.2-99, 9222 B-97, 9222 C-97, and 9223 B-97. 

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.

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 (RC4100T), 1200 Pennsylvania Avenue, NW, Washington, DC 20460. 

5

The m-ColiBlue24® test is described in the document “Membrane Filtration Method mColiBlue24® 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). 
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7 Multiple-tube and multi-well enumerative formats for this method are approved for use 

in presence-absence 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 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-D-glucuronide 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 

contaminant used for compliance monitoring under this rule. 

 

§ 141.853 General monitoring requirements for all public water systems.
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 (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 [INSERT DATE THREE YEARS AFTER PUBLICATION 

OF FINAL RULE]. Systems must collect total coliform samples according to the written 

sample siting plan. These plans are subject to State review and revision. 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. 

(3) A system may conduct more 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 

include the results in calculating whether the coliform treatment technique trigger 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. 

(4) Systems must identify repeat monitoring locations in the sample siting plan. Unless the 

provisions of paragraphs (a)(4)(i) or (a)(4)(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 
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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 State may waive the 

requirement to collect at least one repeat sample upstream or downstream of the original 

sampling site. Except as provided for in paragraph (a)(4)(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 

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 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 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. 
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 (A) If a 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 with a limited number of monitoring locations 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. colipositive. 

 (B) If a system with a limited number of monitoring locations 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. coli-positive, the system has violated the E. 

coli MCL and must also comply with § 141.403(a)(1). 

(5) States may review, revise, and approve, as necessary, repeat sampling proposed by systems 

under paragraphs (a)(4)(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. 
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 (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. 

 (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 within 

five service connections of 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 coliform-
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positive 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 

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. 

§ 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. 
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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. 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 

[INSERT 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 [INSERT DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE]

or unless otherwise directed by the State. 

(2) After [INSERT 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. 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 
Document initiating EO 12866 review 

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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 [INSERT DATE FOUR YEARS AFTER 

PUBLICATION OF THE FINAL RULE], systems on annual monitoring, including seasonal 

systems, must have an initial and 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. 

(e) Reduced monitoring provisions. Beginning [INSERT 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 

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 most recent sanitary survey shows that the system is free of sanitary defects, has a 

protected water source, and meets approved construction standards; 

(2) The system has a clean compliance history for a minimum of 12 months; and 

(3) The State has conducted an annual site visit (recurring) within the last 12 months and the 

system has corrected all identified sanitary defects. The system may substitute a Level 2 

assessment by a party approved by the State for the State annual site visit. 

(f) Increased Monitoring Requirements. 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 
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begin monthly monitoring the month following the event. The system must continue monthly 

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 in a rolling 12 month 

period. 

(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 for a 

system on quarterly monitoring or one subpart Y monitoring violation for a system on annual 

monitoring. 

(g) Requirements for returning to quarterly monitoring. To be eligible to return to quarterly 

monitoring from monthly monitoring triggered under paragraph (f) of this section, a system on 

increased monitoring under paragraph (f) of this section must meet 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. 
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(h) Requirements for annual monitoring. To be eligible for annual monitoring, a system on 

increased monitoring under paragraph (f) of this section must meet 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 (recurring) 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 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. 

(ii) An operator certified by an appropriate State certification program, which may include 

regular visits by a circuit rider. 

(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 [INSERT 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 a startup sample 

prior to serving water to the public. 

(2) Seasonal systems have a routine monitoring frequency of monthly. 

(3) A seasonal system must meet the criteria in paragraphs (i)(3)(i) through (iii) of this section to 

be eligible for monitoring less frequently than monthly after [INSERT DATE THREE YEARS 
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AFTER PUBLICATION OF FINAL RULE], except as provided under paragraph (c) of this 

section. 

(i) The seasonal 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. 

(ii) To be eligible for reduced quarterly monitoring, the system must meet the criteria in 

paragraph (g) of this section. 

(iii) To be eligible for reduced annual monitoring, the system must meet the criteria under 

paragraph (h) of this section. 

(j) Additional routine monitoring. 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. 

(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 
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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 

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. 
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(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. 

(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 [INSERT 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 [INSERT DATE THREE YEARS 

AFTER PUBLICATION OF THE FINAL RULE] or unless otherwise directed by the State. 

(2) After [INSERT 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. 
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(d) Reduced monitoring requirements. (1) The State may reduce the monitoring frequency from 

monthly monitoring to no less than quarterly monitoring if the system is in compliance with 

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 most recent sanitary survey shows the system is free of sanitary defects (or has an 

approved plan and schedule to correct them), has a protected water source and meets approved 

construction standards. 

(ii) The system has a clean compliance history for a minimum of 12 months. 

(iii) The system meets at least one of the following criteria: 

(A) An annual site visit by the State or a 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). 

(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 systems as approved by the State. 

(e) Return to routine 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. 
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(1) The system triggers a Level 2 assessment or two Level 1 assessments in a rolling 12-month 

period. 

(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. 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 
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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 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 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 
Document initiating EO 12866 review 

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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) Beginning [INSERT 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 a startup sample prior to serving water to the 

public. 

(b) Routine monitoring frequency for total coliforms. Subpart H systems (including consecutive 

systems) must monitor monthly. Systems may not reduce monitoring. 

(c) Unfiltered subpart H systems. A subpart H system 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. 

§ 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. 
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(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) Beginning [INSERT 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 a startup sample prior to serving water to the 

public. 

(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 

 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 
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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 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. 

(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 
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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. In the case of an extension, the State must specify how much time 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 ample containers of any 

size, as long as the total volume collected is at least 300 ml. 

(3) If one or more repeat samples in the set is total coliform-positive, the system must collect an 

additional set of repeat samples in the manner specified in paragraphs (a)(1) through (a)(3) of 

this section. The additional samples must be collected 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 repeat this process until either total coliforms are not detected in one complete 
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set of repeat samples or the system determines that a coliform treatment technique trigger has 

been exceeded and notifies the State. After a trigger identified in § 141.859 is reached, systems 

are not required to conduct more than one round of repeat monitoring. 

(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. 

(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 § 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, 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 requirements for protection against potential fecal 

contamination. 
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(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. 

(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, including failure to collect repeat samples within the required time 

following an E. coli- positive routine sample. 

(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 initial samples that caused 

the 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. 
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(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 State may tailor specific 

assessment elements to the size and type of the system. Systems may tailor their assessment 

activities based on the characteristics of the distribution system (consistent with any State 

directives). 

(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 failure to take a 

repeat sample or after notification of monitoring results. In the completed assessment form, the 

system must identify sanitary defects detected, corrective actions completed, and a 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 determination of exceeding the trigger. 

(ii) If the State reviews the completed Level 1 assessment and determines that the assessment is 

not sufficient, the State must consult with the system. If necessary 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. Upon completion and submission of the assessment form 
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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 

paragraph (a)(2) of this section. The State may direct expedited actions or additional actions 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 failure to take a repeat sample or after 

notification of monitoring results. The system must submit a completed Level 2 assessment 

form to the State within 30 days after the determination of exceeding the trigger. The assessment 

form must describe sanitary defects detected, corrective actions completed, and a 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 

insufficient, the State must consult with the system. If necessary after consultation, the system 

must submit a revised assessment form to the State on an agreed-upon schedule not to exceed 30 

days. 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. 
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(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 

compliance with a schedule determined 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. 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). 

(c) Monitoring violations. Failure to take every required routine or additional routine sample in 
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a compliance period is a routine monitoring violation. Failure to analyze for E. coli following a 

total coliform 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 is a reporting violation. 

(2) Failure to notify the State following an E. coli-positive sample as required by § 

141.858(b)(1) is a reporting violation.

§ 141.861 Reporting and recordkeeping. 

 (a) Reporting. (1) A system that has violated the E. coli MCL 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. A system must notify the State no later than the end of the 

next business day after it learns of an E. coli-positive sample. 

(2) A system that has violated the treatment technique for total 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. 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. 

(3) 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. 

(b) Recordkeeping. 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 
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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. 

PART 142 – NATIONAL PRIMARY DRINKING WATER REGULATIONS 

IMPLEMENTATION 

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 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. 
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(A) Sections 141.858(a), 141.853(b)(2), 141.856(c), and 141.857(c) - Any 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 to collect a total coliform sample following a turbidity measurement exceeding 

1 NTU. 

(B) Sections 141.854(j) and 141.855(f)—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) —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) is made, 

the record of the decision must contain all the items listed in that section. 

(D) – Section 141.859 – Completed and approved subpart Y assessments, including reports from 

the system that corrective action has been completed as required by § 141.861(a)(2). 

(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 141.855(d) - 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), including what the reduced monitoring frequency is. A copy of the reduced 

monitoring frequency must be provided to the system. 

(B) Section 141.854(e) - 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), including what the reduced monitoring 

frequency is. A copy of the reduced monitoring frequency must be provided to the system. 
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(C) Section 141.857(d) - 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). A copy 

of the reduced monitoring frequency must be provided to the system. 

(D) Section 141.858(b)(2) - 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. colipositive. 

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, respectively, 

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) Procedures for seasonal systems to start up operations at the beginning of each season. 

25. Section 142.63 paragraph (b) is revised 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) 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 [INSERT DATE THREE YEARS 

FOLLOWING PUBLICATION OF THE FINAL RULE], at which time the total coliform 

MCL is no longer applicable.