Wednesday, 

July 14, 2010 

Part III 

Environmental 

Protection Agency 

40 CFR Parts 141 and 142 

National Primary Drinking Water 

Regulations: Revisions to the Total 

Coliform Rule; Proposed Rule 


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40926 Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Proposed Rules 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 141 and 142 

[EPA–HQ–OW–2008–0878; FRL–9166–8] 

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. This 

proposal also updates provisions in 

other rules that reference analytical 

methods and other requirements in the 

current TCR (e.g., Public Notification 

and Ground Water Rules). 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 September 13, 2010. 

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. 

• Mail: Water Docket, Environmental 

Protection Agency, Mailcode: 4101T, 

1200 Pennsylvania Ave., NW., 

Washington, DC 20460, Attention 

Docket ID No. EPA–HQ–OW–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 Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact 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 e-mail 

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 

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. 


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B. Copies of This Document and Other 

Related Information 

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-Dglucuronide 

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 

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 

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 on the Economic 

Analysis 

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 


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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 

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 health-related or 

technological basis to support a 

regulatory revision that would maintain 

or improve public health protection. In 

the Six-Year Review 1 determination 

published in July 2003 (USEPA 2003, 68 

FR 42908, July 18, 2003), EPA stated its 

intent to revise the 1989 TCR (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. 

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 Web site 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 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 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 


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person who sheds it in his or her feces, 

the pathogen being shed may infect 

other people directly by person-toperson 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 a few 

exceptions, are not harmful to humans. 

Coliforms are abundant in the feces of 

warm-blooded animals, but can also be 

found in aquatic environments, in soil, 

and on vegetation. Coliform bacteria 

may be transported to surface water by 

run-off or to ground water by 

infiltration. Total coliforms are common 

in ambient water and may be injured by 

environmental stresses such as lack of 

nutrients, and water treatments such as 

chlorine disinfection, in a manner 

similar to most bacterial pathogens and 

many viral enteric pathogens (including 

fecal pathogens). EPA considers total 

coliforms to be a useful indicator that a 

potential pathway exists through which 

fecal contamination can enter the 

distribution system. The absence (versus 

the presence) of total coliforms in the 

distribution system indicates a reduced 

likelihood that fecal contamination and/ 

or waterborne pathogens are occurring 

in the distribution system. 

Under the 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 

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 U.S. Centers for Disease Control 

and Prevention (CDC) estimates that 

there are 73,000 cases of illness each 

year in the U.S. 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. 

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). Underreporting 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 

usual ongoing occurrence of illness in a 

given population or geographic area 

(Craun et al. 2006). 

III. Proposed Revised Total Coliform 

Rule 

The proposed RTCR maintains and 

strengthens the objectives of the current 


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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 

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 coliformpositive 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 number of additional routine 

samples from the current TCR, which 

requires at least five routine samples in 

the month following a total coliformpositive 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 Stateapproved start-up procedure. In 

addition, they must designate the time 

period(s) for monitoring based on sitespecific 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 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. 


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A. Proposed Rule Provisions and 

Rationale 

1. Terms used in the proposed RTCR 

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 

coliform treatment technique trigger 

exceedances or coliform 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 in 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. 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 Interim Enhanced Surface 

Water Treatment Rule (IESWTR) 

(USEPA 1998b, 63 FR 69389, December 

16, 1998) 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. 

• 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 does not maintain adequate 

pressure throughout the distribution 

system. The AIP describes a seasonal 

system as ‘‘one which operates less than 

four calendar quarters per year’’ (USEPA 

2008c). EPA has interpreted this to 

mean that a seasonal system is one 

which is shut down for at least one full 

calendar quarter (i.e., it operates in three 

or fewer calendar quarters). EPA 

requests comment on whether this 

proposed definition of ‘‘seasonal 

system’’ is adequate to address the 

concern that motivated the advisory 

committee’s recommendation and is 

consistent with its intent. 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 (i.e., in only 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 


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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 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 coliformpositive routine sample; or 

• A routine sample is E. coli-positive 

and one of its associated repeat samples 

is total coliform-positive; 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. colipositive sample. Although not explicitly 

stated, as a logical consequence of the 

second condition, a system also violates 

the MCL when an E. coli-positive 

routine sample is followed by an E. colipositive repeat sample because E. coli 

are a subset of total coliforms. 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 

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 

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 E. coli with sufficient 

frequency to ensure such safety. 

Because total coliform bacteria are 

part of the soil ecosystem, positive 

samples are indicators of fecal 

contaminant entry into drinking water 

via a pathway from the soil. EPA is 

proposing a coliform treatment 

technique, supplemental to directly 

measuring E. coli, to provide additional 

protection against fecal contamination. 

Under the proposed coliform treatment 

technique, as specified in the AIP, total 

coliform-positive samples, in the 

absence of E. coli, are still indicators of 

an E. coli or other fecal contaminant 

pathway. 

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. 

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 require PWSs to investigate 

the potential causes of the fecal 

contamination and require timely 

remedial action if any sanitary defects 


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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 may not be identified 

and eliminated as 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 

any sanitary defect and reduce 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. 

As discussed in section II.D.2 of this 

preamble, the presence of total 

coliforms indicates the potential 

existence of a pathway through which 

fecal contamination could follow. The 

absence (versus the presence) of total 

coliforms in the distribution system 

indicates a reduced likelihood that fecal 

contamination and/or waterborne 

pathogens are occurring in the 

distribution system. Analyses from 

EPA’s 2005 Six-Year Review 2 data 

(USEPA 2006b; USEPA 2010e) (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 2010a)). 

Similarly, under the current TCR, nonacute 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). 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 identifying set repeat 

sampling locations (i.e., within five 

service connections upstream and 

downstream of the original sampling 

location that tested total coliformpositive), 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 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. In addition, systems 

on annual monitoring, including 

seasonal systems, must have an initial 

annual site visit by the State within one 

year of the compliance date (or an 

annual voluntary Level 2 assessment by 

a party approved by the State) and an 

annual site visit each year thereafter to 

remain on annual monitoring. 

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 


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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 sitespecific considerations (such as during 

periods of highest demand or highest 

vulnerability to contamination). The 

system must collect compliance samples 

during these time periods. 

(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: 

• 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: 

• An annual site visit (recurring) by 

the State and correction of all identified 

sanitary defects. An annual voluntary 

Level 2 assessment may be substituted 

for the State annual site visit in any 

given year; and 

• The system must have in place or 

adopt one or more additional 

enhancements to the water system 

barriers to contamination as approved 

by the State. These measures could 

include but are not limited to the 

following: 

—Cross connection control, as approved 

by the State; 

—An operator certified by an 

appropriate State certification 

program, which may include regular 

visits by a circuit rider; 

—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 Stateapproved 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: 

• 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 coliformpositive 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 


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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, 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 coliformnegative. 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. 

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; 

• 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 or 

meeting criteria established 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. 

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 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 

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 


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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 coliformnegative. 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 of this part 

serving ≤ 1,000 people. The monitoring 

requirements for subpart H systems of 

this part (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 coliformpositive sample. 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 Stateapproved 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. In addition, EPA is proposing 

to require State approval if a ground 

water system serving 1,000 or fewer 

people wants to use a single sample to 

meet both the repeat monitoring 

requirements of the RTCR and the 

source water monitoring requirements 

of the GWR (see section III.A.4 of this 

preamble for further discussion of this 

topic). 

EPA is proposing to allow the use of 

dedicated sampling locations for the 

following reasons: 

• 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. 

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 


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and maintenance issues to maintain 

existing monitoring frequency or qualify 

for reduced monitoring. Systems on 

reduced TCR monitoring stay on 

reduced monitoring during the 

transition period if they continue to 

meet the reduced monitoring criteria. 

During the special monitoring 

evaluation conducted as part of the 

periodic sanitary survey, the State will 

determine whether the individual 

systems are on the proper monitoring 

schedule. 

(c) Reduced monitoring. The reduced 

monitoring requirements are intended to 

recognize that well-operated systems 

may be less vulnerable to 

contamination. Therefore, certain 

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. 

(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 coliformpositive sample would not take any 

samples the 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 2010a) 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 coliformpositive), the assessment and corrective 

action provisions lead to more E. coli 

MCL violations being prevented 

compared to the current TCR (see 

Exhibit 6–7 of the Proposed RTCR EA 

(USEPA 2010a) 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 coliformpositive, 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 


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40938 Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Proposed Rules 

additional routine sampling for the 

following month. 

iii. Subpart H systems of this part 

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 of this part. The advisory 

committee recommended that no 

reduced routine monitoring provisions 

be allowed for subpart H systems of this 

part 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 coliformpositive sample for PWSs serving 

between 1,000 and 4,100 people for the 

same reasons discussed previously for 

small 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)? What start-up 

procedures or other provisions 

regarding seasonal systems would be 

appropriate for inclusion in such 

guidance? 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. 

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-bycase 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 coliformpositive 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. Unless different locations are 

specified in its sample siting plan, the 

system must also collect at least one 

repeat sample at a tap within five 

service connections upstream, and at 

least one repeat sample at a tap within 

five service connections downstream of 

the original sampling site. The State 

may waive the requirement to collect at 

least one repeat sample upstream or 

downstream of the original sampling 

site if the total coliform-positive sample 

is at the end of the distribution system, 

or one service connection away from the 

end of the distribution system. The 

system may also propose alternative 

repeat monitoring locations in its 

sample siting plan 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. coli-positive and the other 

is E. coli-negative, the system has an E. 

coli MCL violation under the proposed 

RTCR and is required to take four 

additional source water samples, rather 

than five, under the GWR (see 40 CFR 

141.402(a)(3)). If the system takes more 

than one of these repeat samples at the 

triggered source water monitoring 

location and has more than one repeat 

sample that is E. coli-positive, then the 

system would have both 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. 

Under the proposed rule, the system 

must collect all repeat samples on the 

same day consistent with current TCR 

requirements. The State may allow 


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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 

required to conduct only one round of 

repeat monitoring after each total 

coliform-positive or E. coli-positive 

routine sample. If a trigger is reached as 

a result of a repeat sample being total 

coliform- or E. coli-positive, no further 

repeat monitoring related to that sample 

is necessary. 

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 coliformpositive sample. EPA believes that 

sampling immediately after an initial 

positive 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 

(USEPA 2010e) 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 (USEPA 2010e) 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 coliformpositive 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 (USEPA 2010e). The relative 

probability is defined as the ratio of the 

probability of getting a total coliformpositive result from a repeat sample to 

the probability of getting a total 

coliform-positive result from a routine 

sample. 

EXHIBIT III–1—RELATIVE PROBABILITY OF TOTAL COLIFORM-POSITIVE SAMPLES IN ROUTINE COMPARED TO REPEAT

SAMPLES

System type 1

Average 

pRTTC 2

(percent) 

Average 

pRPTC 3

(percent) 

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 


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EXHIBIT III–1—RELATIVE PROBABILITY OF TOTAL COLIFORM-POSITIVE SAMPLES IN ROUTINE COMPARED TO REPEAT

SAMPLES—Continued 

System type 1

Average 

pRTTC 2

(percent) 

Average 

pRPTC 3

(percent) 

Ratio 

pRPTC/ 

pRTTC 

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 

1The 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. 2Average probability of a total coliform-positive from a routine total coliform sample. 

3Average probability of a total coliform-positive from a repeat total coliform sample. 

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 coliform-positive rate (19 

percent) is about six times as great as 

the average routine total coliformpositive 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 coliformpositive 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 coliformpositive 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 coliformpositive on horizontal axis), which is 

about 13 times greater than that of the 

routine samples. 


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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 (USEPA 2010e). 

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 

(USEPA 2010e) 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 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. 


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EXHIBIT III–3—PERCENTAGE OF INSTANCES WITH 1 OR >1 POSITIVE REPEAT SAMPLES AMONG THOSE INSTANCES IN

WHICH ≥1 REPEAT SAMPLES IS POSITIVE

System category 

Number of positive repeat 

samples 

1 > 1 

Undisinfected GWSs Serving ≤1000 ....................................................................................................................... 23% 77% 

All PWSs Serving ≤1000 ......................................................................................................................................... 25 75 

Note: Based on the analysis of Six-Year Review 2 dataset (USEPA 2010e) (described in chapter 4 of the Proposed RTCR EA (USEPA 

2010a)). 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 2010a). 

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 

events 1 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 

events 1 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% 

1Based on the analysis of the Six-Year Review 2 dataset (USEPA 2010e) (described in chapter 4 of the Proposed RTCR EA (USEPA 2010a)). 

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 2010a). 

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 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 exceeding the trigger). 

Moreover, because of the substantial 

cost of this potential consequence, 

systems would be more likely to take all 

of their required repeat 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 2010a)). 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 the required 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). 

As under the existing GWR and 

current TCR, 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 count toward 

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. colipositive sample occurs. The advisory 

committee recommended this flexibility 

to reduce the burden on small ground 

water 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 


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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 (SOPs) as part of 

their sample siting plan to identify 

alternative monitoring sites and 

facilitate the identification of the source 

and extent of any problem. EPA is not 

requiring prior State approval for this 

provision since there is no reduction in 

monitoring and the SOP is expected to 

be used only by larger systems with the 

technical resources to justify alternative 

monitoring sites. 

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. Consistent 

with its understanding of the intent of 

the TCRDSAC, EPA has proposed that 

systems be allowed to exercise this 

flexibility only with prior State 

approval. State approval is required 

because this constitutes a reduction in 

monitoring (no separate triggered source 

water samples). EPA believes that this 

reduction in monitoring is appropriate 

only if the State determines that the 

dual purpose sample provides public 

health protection equivalent to that 

provided by separate repeat and source 

water samples. EPA believes that many 

ground water systems serving 1,000 or 

fewer people, such as systems with 

extensive distribution systems, will not 

be able to show that this reduction in 

monitoring (i.e., a loss of repeat sample 

that is near the total coliform-positive 

routine sample site, but not near the 

source water sample site) will provide 

public health protection equivalent to 

separate samples. EPA believes that 

systems with limited or no distribution 

systems are the best candidate for 

approval. 

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. EPA is also 

requesting comment on whether 

systems should be allowed to use a dual 

purpose sample simply by including 

that in the sample siting plan, without 

prior State approval. Also, should 

systems using repeat monitoring sites 

more than five connections upstream or 

downstream from the routine total 

coliform-positive site be required to get 

prior State approval? 

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 a 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 coliform-positive sample. 

Level 2 treatment technique triggers: 

• 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 coliformpositive 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, 

• 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 coliformpositive 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 


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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. 

The completed assessment form must 

include assessments conducted, all 

sanitary defects identified (or a 

statement that no sanitary defects were 

identified), corrective actions 

completed, and a timetable for any 

corrective actions not already 

completed. 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 X 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 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. 

The completed assessment form must 

include assessments conducted, all 

sanitary defects (or a statement that no 

sanitary defects were identified), 

corrective actions completed, and a 

timetable for any corrective actions not 

already completed. 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. 

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 the 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 

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. If the 

system does conduct the assessment and 

satisfies the requirements of the 

treatment technique (including 

corrective action when a sanitary defect 

is identified), no public notification is 

required. 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 


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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 coliformpositive 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. 

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 RTCR specifies 

the same minimum elements for both 

the Level 1 and Level 2 assessments, the 

Level 2 assessment involves a more indepth 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 

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 (which 

may include additional or more detailed 

assessment or engineering studies) to be 

completed as soon as possible. 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 non-acute 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?). Should EPA 

provide more detail, either in guidance 

or rule language, on the elements and 

differences between a Level 1 and Level 

2 assessments? If in rule language, how 

should the rule language distinguish the 

two levels of assessments? Please 

provide examples. Additionally, should 

EPA provide additional guidance on 

how systems might address the situation 

where a Level 1 or Level 2 assessment 


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fails to identify any sanitary defects (i.e., 

the trigger event remains unexplained). 

If so, what should such guidance say? 

6. Violations 

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 coliformpositive and one of its associated repeat 

samples is E. coli-positive; or 

• A routine sample is E. coli-positive 

and one of its associated repeat samples 

is total coliform-positive; 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). 

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 coliformpositive. 

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 

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 

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 an 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. colipositive 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. The language 

for a non-acute violation under the 

current TCR is modified to apply to a 

violation of the assessments and 

corrective action requirements of the 

coliform treatment technique. 

In the current TCR, a system is 

required to publish a Tier 2 PN when 

the system has a non-acute MCL 

violation, which is based on total 


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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. 

In the current TCR, a system is 

required to publish a Tier 3 PN when 

the system has a monitoring or 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 distinct 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 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 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 

141.403(a)(7)(ii), an NCWS that receives 

notice from the State of 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. coli-positive 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. 


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• 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). 

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 

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 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 Web site 

at www.epa.gov/etv/index. 

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. 


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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 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, 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 nonfecal bacteria, the fecal coliform group 

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 AIPrelated 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. 

• 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 


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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.’’ 

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. enzyme-substrate 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. 

• 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-BetaD-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 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 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) 


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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 presterilized. 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. 

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. 

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 μg/ 

mL of 4-methylumbelliferyl-Beta-Dglucuronide (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 

9222G.1a(2) formulation calls for 0.1 g 

of 4-methylumbelliferyl-Beta-Dglucuronide, 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.1a(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. 

EPA recognizes that requiring the 

samples under the proposed RTCR to be 

held at 10 degrees C or less, but above 


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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 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 of this part 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 2009), 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. 

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 began 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.’’ 

• 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 2006d, 71 FR 654, January 5, 


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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 

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 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 coliformpositive 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 requirements 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). 

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 


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being a more significant concern. Other 

water quality problems associated with 

sediment accumulation include 

increased disinfectant demand and 

disinfection byproduct formation. 

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 

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: 

• 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. 

• 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. 


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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, 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 will 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 coliformpositive 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 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, 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 of this part 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 coliformpositive 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 

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 coliform-positive sample if that 

system assumes that the total coliformpositive sample is E. coli- positive. 

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 


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systems, including the compliance date 

(the date that reduced monitoring was 

approved) of the reduced monitoring 

requirement for each system. 

D. Interim Primacy 

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 

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 information and research will 

allow better understanding and 

management of potential public health 

risks from drinking water distribution 

systems. See http://www.epa.gov/ 

safewater/disinfection/tcr/ 

regulation_revisions_tcrdsac.html 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 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&nav

ItemNumber=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 


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that a water system should implement 

to achieve long-term 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 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 2010a) 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 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 2010a). 

The benefits described in this section 

are discussed qualitatively, and 

reductions in detection of total 

coliforms and E. coli and in Level 2 

assessments are used to describe the 

benefits, as described later in this 

section. The costs discussed in this 

section are presented as annualized 

present values in 2007 dollars. Both 

benefit and cost measures are adjusted 

using social discounting. In social 

discounting, future values of a rule’s or 

policy’s effects are multiplied by 

discount factors. The discount factors 

reflect both the amount of time between 

the present and the point at which these 

events occur and the degree to which 

current consumption is more highly 

valued than future 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 financial instruments, while 

seven percent is generally an estimate of 

before-tax rate of return to incremental 

private investment. For further 

information, see USEPA 2000c and 

OMB 1996. 

In the Proposed RTCR EA (USEPA 

2010a), 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 SixYear Review 2 dataset (USEPA 2010e) 

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 2010a), 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 and 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 


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rule proposal: (1) The current TCR 

option, (2) the AIP option, and (3) an 

Alternative option. EPA discusses the 

three regulatory options briefly in this 

preamble and in greater detail in 

chapter 3 of the Proposed RTCR EA 

(USEPA 2010a). 

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. 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 2010a) to assess the relative 

impacts of a more stringent rule and to 

better understand the balance between 

costs and public health protection. 

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 2010a). 

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 2010a). 

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 nontransient non-community water system 

(NTNCWS)). 

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 2010c) 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) 

• 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 2010a), 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 

(USEPA 2010e). 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 (USEPA 

2010e) 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 2010b), the 

U.S. 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 


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this preamble, the model developed for 

this economic analysis considers the 

effect of GWR both before and during 

implementation of 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. U.S. 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 2010a). 

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 (USEPA 2010e). 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 (USEPA 2010e) 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. 

Chapter 5 of the Proposed RTCR EA 

(USEPA 2010a) 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 U.S. 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. 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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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 

the GWR, which became effective in 

December 2009. EPA assumed these five 

years to account for the approximately 

two years before the expected 

promulgation date of the final RTCR and 

an additional three years after that until 

the RTCR effective date. The 

assumptions made to account for the 

GWR are described in detail in the 

Proposed RTCR EA (USEPA 2010a) 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 water 

samples (unless the State requires corrective action). If any of these 

is positive, they must conduct corrective action.

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 disinfection or implement a nondisinfecting corrective action as described in Proposed RTCR EA (USEPA 2010a). 

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 75 1 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 percent 2 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 percent 3 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 2010a) 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 

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 2010a) 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 percent 1 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 2010a). 

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 percent 2 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 percent 3 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 2010a). 

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 percent 4 reduction in occurrence for five additional years. 

1 3Assumption based on conversation with State representatives with on-the-ground experience. 2 4Assumption reflects EPA best professional judgment. 


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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 2010a). 

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 (USEPA 

2010e) for PWSs serving more than 

4,100 people were not as robust as the 

Six-Year Review 2 data (USEPA 2010e) 

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 (USEPA 2010e) 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 

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. 

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 (USEPA 2010e) and 

individual State statutes conducted by 

EPA and the advisory committee 

Technical Work Group (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 coliformand 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 


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systems than in surface water systems; in smaller systems than in larger 

systems; and in NCWSs than in CWSs. 

BILLING CODE 6560–50–P 

BILLING CODE 6560–50–C 


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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 

in chapter 5 of the Proposed RTCR EA 

(USEPA 2010a), 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) 

GW PWSs SW PWSs All PWSs 

total Non-acute Acute Total Non-acute Acute Total 

CWSs 

≤ 100 ......................................................... 905 52 957 16 3 19 976 

101–500 ................................................... 809 34 843 50 7 57 900 

501–1,000 ................................................ 203 13 216 16 3 19 235 

1,001–3,300 ............................................. 272 8 280 55 7 62 342 

3,301–10,000 ........................................... 171 8 179 75 3 78 257 

10,001–50,000 ......................................... 125 8 133 78 4 82 215 

50,001–100,000 ....................................... 11 2 13 5 4 9 22 

100,001–1 Million ..................................... 1 1 2 3 1 4 6 

> 1 Million ................................................. .................... .................... .................... 1 .................... 1 1 

Totals ................................................ 2,497 126 2,623 299 32 331 2,954 

NTNCWSs 

≤ 100 ......................................................... 514 34 548 7 2 9 557 

101–500 ................................................... 346 20 366 4 .................... 4 370 

501–1,000 ................................................ 57 6 63 2 .................... 2 65 

1,001–3,300 ............................................. 58 4 62 .................... .................... .................... 62 

3,301–10,000 ........................................... 9 2 11 1 .................... 1 12 

10,001–50,000 ......................................... 1 .................... 1 .................... .................... .................... 1 

50,001–100,000 ....................................... .................... .................... .................... .................... .................... .................... ....................

100,001–1 Million ..................................... .................... .................... .................... .................... .................... .................... ....................

> 1 Million ................................................. .................... .................... .................... .................... .................... .................... ....................

Totals ................................................ 985 66 1,051 14 2 16 1,067 

TNCWSs 

≤ 100 ......................................................... 2,665 278 2,943 19 5 24 2,967 

101–500 ................................................... 833 76 909 11 1 12 921 

501–1,000 ................................................ 133 11 144 4 .................... 4 148 

1,001–3,300 ............................................. 58 2 60 1 .................... 1 61 

3,301–10,000 ........................................... 5 .................... 5 1 .................... 1 6 

10,001–50,000 ......................................... .................... .................... .................... .................... .................... .................... ....................

50,001–100,000 ....................................... .................... .................... .................... .................... .................... .................... ....................

100,001–1 Million ..................................... .................... .................... .................... .................... .................... .................... ....................

> 1 Million ................................................. .................... .................... .................... .................... .................... .................... ....................

Totals ................................................ 3,694 367 4,061 36 6 42 4,103 

Grand Total ................................ 7,176 559 7,735 349 40 389 8,124 

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, U.S. territories, Tribal PWS data excluded. See the Proposed RTCR EA (USEPA 2010a) 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 EA (USEPA 2010a) 

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 

(USEPA 2010e) 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. 


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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 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 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 2010a). 

EPA chose to include the 

characterization for TNCWSs because 

they represent the system category of 

largest influence on the national 

impacts. 


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The effect that the proposed changes 

to public notification requirements for 

monthly/non-acute 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 

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 2010a) 

presents a detailed discussion of the 

potential influence on health risk for 

each proposed rule component. 

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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 nonacute 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 

2010a) 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 

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 


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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 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 2010a). 

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 

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 more 

closely with expected benefits (that is, 

reductions in adverse health outcomes) 

than non-acute events (as presented in 

Exhibit VI–9) because E. coli violations 

are a direct result of measurement of 

fecal contamination in water. A similar 

but smaller reduction is seen under the 

Alternative option after steady state is 

achieved. This is the result of two offsetting effects. The ‘‘true’’ number of 

steady state violations under the 

Alternative option is lower because 

there is a greater likelihood that 

violations will be found and fixed. 

However, the additional monitoring 

leads to a higher percentage of 

violations being detected. This second 

effect outweighs the first, so that the 

total number of detected violations in 

the steady state is higher than for the 

AIP, even though the underlying ‘‘true’’ 

number of violations is lower. This 

lower number of ‘‘true’’ violations means 

that the Alternative option is more 

protective of public health, even though 

more violations are detected. 

Exhibit VI–11 presents estimates over 

the 25-year period of analysis of the 

increase in corrective actions (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 

2010a) 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. 

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–11 indicate 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 


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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 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). 

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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 of the Proposed RTCR EA 

(USEPA 2010a), 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. 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 (USEPA 2010e) 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. 

b. Other nonquantifiable benefits. 

Other nonquantified benefits may 

include those associated with 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. 

Some systems may see additional 

nonquantified benefits associated with 

the acceleration of their capital 

replacement fund investments in 

response to early identification of 

impending problems with large capital 

components. Although such capital 

investment will eventually occur 

anyway, earlier investment may ensure 

that problems are addressed in a 

preventive manner and may preclude 

some decrease in protection that might 

have occurred otherwise. At the very 

least, the increased operator awareness 

is expected to reduce the occurrence of 

unplanned capital expenditures in any 

given year. However, because of the 

difficulty of projecting when capital 

replacements would occur, EPA has not 

costed this acceleration of capital 

replacement, so there would also be a 

nonquantified cost of making such 

investments sooner. 

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 

bottled water and point-of-use devices. 

This benefit also includes the 

reductions in time spent on averting 

behavior such as the time spent 

obtaining alternative water supplies. 

F. Anticipated Costs of the 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, and to estimate cost relative to a 

baseline of no RTCR. Then, EPA 

considered the net change in costs that 

results from implementing the AIP or 

Alternative options 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 is 

provided in the sections that follow and 

a complete discussion can be found in 

chapter 7 of the Proposed RTCR EA 

(USEPA 2010a). 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. 

These present value costs are then 

annualized over the 25-year period 

using the two discount rates. 

Exhibit VI–15 summarizes the 

comparison of total and net change in 

annualized present value of the AIP and 

Alternative options relative to the 

current TCR baseline. 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 


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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. 

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. 

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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. 

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 


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read and 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 onetime 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. Under the AIP 

and Alternative options, additional 

routine monitoring is no longer required 

for systems that monitor at least 

monthly, and when additional routine 

monitoring is required, the number of 

samples required is reduced from five to 

three. Cost reductions are greater under 

the Alternative option than under the 

AIP because under the Alternative 

option all PWSs start on monthly 

monitoring and are not required to take 

additional routine samples during that 

period. 

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. Under the 

AIP and Alternative options, they will 

only need to take three repeat samples, 

and they have greater flexibility about 

where to take them, consistent with the 

system sample siting plan that is 

developed in accordance with RTCR 

requirements and subject to review and 

revision by the State. The number of 

repeat samples required for PWSs 

serving more than 1,000 people is the 

same under the current TCR and the AIP 

and Alternative options, although they 

too have greater flexibility in sample 

location. 

Exhibit VI–18 summarizes the 

cumulative number of samples taken by 

PWS size and category for routine, 

additional, and repeat monitoring under 

the 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 2010a) 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 

are presented in Exhibit VI–19. 

BILLING CODE 6560–50–P 


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BILLING CODE 6560–50–C 

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. Annual site visits. Under the AIP, 

any PWS on an annual monitoring 

schedule is required to also have an 

annual site visit conducted by the State 

or State-designated third party. A 

voluntary Level 2 site assessment can 

also satisfy the annual site visit 

requirement. For years in which the 

State performs a sanitary survey (at least 

every five years for NCWSs and three 

years for CWSs), a sanitary survey 

performed during the same year can also 

be used to satisfy this requirement. EPA 

uses the same assumptions to estimate 

costs associated with site visits for both 

the AIP and Alternative options. 

e. Assessments. Annualized cost 

estimates for Level 1 and Level 2 

assessments under the TCR, AIP, and 

Alternative options are calculated in the 

Proposed RTCR EA (USEPA 2010a) by 

multiplying the number of assessments 

estimated by the predictive modeling 

(summarized in Exhibit 7.13 of the EA) 

by the unit costs (summarized in 

Exhibits 7–11 and 7–12 of the EA). 

Appendix A of the Proposed RTCR EA 

(USEPA 2010a) 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 

of this preamble. 


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Under the proposed RTCR, all PWSs 

are required to conduct assessments of 

their systems when they exceed Level 1 

or Level 2 treatment technique triggers. 

While PWSs are not required to conduct 

assessments under the current TCR, 

some PWSs do currently engage in 

assessment activity (which may or may 

not meet the proposed RTCR criteria) 

following non-acute and acute MCL 

violations. EPA estimates both the costs 

to PWSs to conduct assessments under 

the proposed RTCR as well as the level 

of effort that PWSs already put towards 

assessment activities under the current 

TCR. These estimates are based on the 

work of the stakeholders in the 

Technical Work Group (TWG) during 

the proceedings of the TCRDSAC. These 

estimates allowed EPA to determine the 

average net costs to conduct 

assessments under the proposed RTCR. 

EPA assumes that the numbers of nonacute and acute MCL violations would 

remain steady under a continuation of 

the current TCR (based on review of 

SDWIS/FED violation data). Under the 

proposed RTCR, EPA assumes that the 

numbers of assessments decreases from 

the steady state level seen under the 

current TCR over time to a new steady 

state level as a function of reduced fecal 

indicator occurrence associated with the 

effects of requiring assessments and 

corrective action. 

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 

2010a). 

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 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 

2010a), along with summary tables of 

the unit costs used in the analysis. Each 

corrective action in the detailed 

compliance forecast is also assigned a 

representative unit cost. Detailed 

descriptions of the derivation of unit 

costs are provided in Exhibits 5–1 


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through 5–47 of the Technology and Cost Document for the Proposed Revised 

Total Coliform Rule (USEPA 2010b). 

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 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. Consistent with 

the discussions of the TCRDSAC 

regarding major structural fixes or 

replacements, EPA did not include 

these major costs in the analysis. 

Distribution system appurtenances such 

as storage tanks generally have a useful 

life that is accounted for in water system 

capital planning and the assessments 

conducted in response to RTCR triggers 

could identify when that useful life has 

ended but are not solely responsible for 

the need to correct the defect. In 

addition, EPA ran two sensitivity 

analyses to assess the potential impacts 

of different distributions within the 

compliance forecast. Results of the 

sensitivity analyses are presented in 

Exhibit 7–24 of the Proposed RTCR EA 

(USEPA 2010a), which indicates that 

the low bound estimates of annualized 

net change in costs at three percent 

discount rate are approximately $3M for 

the AIP option and $15M for the 

Alternative option, and the high bound 

estimates are approximately $25M for 

the AIP option and $40M for the 

Alternative option. Varying the 

assumptions about the percentage of 

corrective actions identified and the 

effectiveness of those actions had less 

than a linear effect on outcomes, and the 

AIP option continues to be less costly 

than the Alternative option under all 

scenarios modeled. 

As indicated in the more detailed 

analysis presented in chapter 7 of the 

Proposed RTCR EA (USEPA 2010a), 

PWSs also incur reporting and 

recordkeeping burden to notify the State 

upon completion of each corrective 

action. PWSs may also consult with the 

State or with outside parties to 

determine the appropriate corrective 

action to be implemented. 

Annualized cost estimates for PWSs 

to perform corrective actions are 

estimated by multiplying the number of 

Level 1 and Level 2 corrective actions 

estimated by the predictive model, (i.e., 

10 percent of Level 1 and Level 2 

assessments) by the percentages in the 

compliance forecast and unit costs of 

corrective actions and associated 

reporting and recordkeeping. Exhibit 

7.13 of the proposed RTCR EA (USEPA 

2010a) presents the estimated totals of 

non-acute and acute MCL violations 

(current TCR) and Level 1 and Level 2 

assessments (AIP and Alternative 

options). The model predicts a total of 

approximately 109,000 single non-acute 

MCL violations, 58,000 cases of a 

second non-acute MCL violation, and 

16,000 acute MCL violations for the 

current TCR, under which some PWSs 

currently engage in assessment activity 

which may or may not meet the 

proposed RTCR criteria (see section 

7.4.5 of the proposed RTCR EA (USEPA 

2010a) for details). For the AIP option, 

the model predicts approximately 

104,000 Level 1 assessments and 52,000 

Level 2 assessments. For the Alternative 

option, the model predicts 

approximately 115,000 Level 1 

assessments and 78,000 Level 2 

assessments. The total and net change 

costs of corrective actions are shown in 

Exhibit VI–22. 


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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 

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 2010a). 

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 2010a) 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. 

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 2010a). 

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 annual site visits, 

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 2010a) 

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 

staff to establish and maintain the 

programs necessary to comply with the 

proposed RTCR, including developing 

and adopting State regulations and 


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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 2010a) 

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 underestimate 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. 

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. Annual site visits. Under the AIP 

option, any PWS on an annual 

monitoring schedule is required to also 

have an annual site visit conducted by 

the State or State-designated third party. 

A voluntary Level 2 site assessment can 

also satisfy the annual site visit 

requirement. In many cases a sanitary 

survey performed during the same year 

can also be used to satisfy this 

requirement. Although similar site visits 

are not currently required under the 

current TCR, discussions with States 

during the TCRDSAC proceedings 

revealed that some do, in fact, conduct 

such site visits for PWSs on annual 

monitoring schedules. Because of the 

high cost for an annual site visit by a 

State, for this analysis EPA assumed 

that no States choose to conduct annual 

site visits unless they already do so 

under the current TCR. Therefore, for 

overall costing purposes, no net change 

in State or PWS costs are assumed for 

annual monitoring site visits 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 to the current TCR (as 

explained in chapter 7 of the Proposed 

RTCR EA (USEPA 2010a), 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 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. 


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EXHIBIT VI–24—ANNUALIZED STATE COST ESTIMATES FOR PUBLIC NOTIFICATION

[$Millions, 2007$] 

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 2010a). 

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, cost 

reductions related to fewer monitoring 

and reporting violations are not 

specifically accounted for in the cost 

analysis, and their exclusion from 

consideration may result in an 

overestimate of net change in cost 

between the TCR option and the AIP 

option or Alternative option. 

In addition 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 Reports (CCRs). 

Because of the use of the CCR to 

communicate Tier 3 public notification 

on a yearly basis, no cost differential 

between the current 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. System resources used to 

process monitoring violation notices for 

the CCR and respond to customer 

inquiries about the notices, as well as 

State resources to remind systems to 

take samples, may be reduced if 

significant reductions 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. Such cost savings to 

States may be significant given the high 

occurrence of monitoring and reporting 

violations under 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. 

G. Potential Impact of the Proposed 

RTCR on Households 

The household cost analysis considers 

the potential increase in a household’s 

annual water bill if a CWS passed the 

entire cost increase resulting from the 

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 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 not perform 

corrective actions over the 25-year 

period of analysis (because no sanitary 

defects are found). These households 

experience a slight cost savings on an 

annual basis. 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. 


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EXHIBIT VI–25—SUMMARY OF NET ANNUAL PER-HOUSEHOLD COSTS FOR THE PROPOSED RTCR (2007$) 

Population served by PWS 

3% Discount rate 7% Discount rate 

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 0.00 0.00 

Total .......................................................................................... 0.00 0.01 0.01 0.02 

Source: Proposed RTCR EA (USEPA 2010a). 

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 2010a). 

Incremental costs and benefits are 

those that are incurred or realized to 

reduce potential illnesses and deaths 

from one alternative to the next more 

stringent alternative. Estimates of 

incremental costs and benefits are 

useful when considering the economic 

efficiency of different regulatory 

alternatives considered by EPA. One 

goal of an incremental analysis is to 

identify the regulatory alternatives 

where net social benefits are 

maximized. However, incremental net 

benefits analysis is not possible when 

benefits are not monetized as in the case 

with the proposed RTCR. 

However, incremental analysis can 

still provide information on relative 

cost-effectiveness of different regulatory 

options. For the proposed RTCR, only 

costs were monetized. While benefits 

were not quantified, an indirect proxy 

for benefits was. 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 

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 non-monetized corrective 

action endpoints are discounted in 

order to make them comparable to 

monetized endpoints. The relationship 

between the incremental costs and 

benefits is examined further with 

respect to cost effectiveness in section 

VI.M of this preamble. 

EXHIBIT VI–26—INCREMENTAL NET CHANGE IN ANNUALIZED PRESENT VALUE COSTS ($MILLIONS, 2007$) AND BENEFITS

(NUMBER OF CORRECTIVE ACTIONS) 

Regulatory option 

Costs Benefits 

(L2 corrective actions) 

3% 7% 3% 7% 

Current TCR .................................................................................................... $186.1 $178.4 3 No change 3 No change 

AIP ................................................................................................................... 199.8 192.5 202 189 

Incremental AIP1 ............................................................................................. 13.7 13.7 202 189 


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EXHIBIT VI–26—INCREMENTAL NET CHANGE IN ANNUALIZED PRESENT VALUE COSTS ($MILLIONS, 2007$) AND BENEFITS

(NUMBER OF CORRECTIVE ACTIONS)—Continued 

Regulatory option 

Costs Benefits 

(L2 corrective actions) 

3% 7% 3% 7% 

Alternative ........................................................................................................ 213.3 208.5 317 323 

Incremental Alternative 2 .................................................................................. 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 2010a). 3As explained in section VI.F.2.f of this preamble, for modeling purposes, EPA estimates the net change only in the number of corrective actions performed under the AIP and Alternative options compared to the current TCR and thus did not quantify the (non-zero) baseline number of 

corrective actions performed under the Current TCR. 

I. Benefits From Simultaneous 

Reduction of Co-Occurring 

Contaminants 

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. 

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. For example, 

eliminating a cross connection reduces 

the potential for chemical 

contamination as well as microbial. Due 

to a lack of contamination co-occurrence 

data that could relate to the effect that 

treatment corrective action may have on 

contamination entering through 

distribution system pathways, EPA has 

not quantified such potential benefits. 

J. Change in Risk From Other 

Contaminants 

All surface water systems are already 

required to disinfect under the SWTR 

(USEPA 1989b, 54 FR 27486, June 29, 

1989) but 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 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. 

EPA does not expect many previously 

undisinfected systems to add 

disinfection as a result of either the AIP 

or Alternative rule options. Ground 

water systems that are not currently 

disinfecting may eventually install 

disinfection if RTCR distribution system 

monitoring and assessments, and/or 

subsequent source water monitoring 

required under the GWR, result in the 

determination that source water 

treatment is required. However, these 

impacts were already accounted for and 

costed under the GWR and EPA does 

not project additional systems switching 

to disinfection as a result of the RTCR. 

See section 7.4.6 of the Proposed RTCR 

EA (USEPA 2010a) 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 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-toperson 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, 


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more severe illness (and sometimes 

death) can occur. 

Examples of sensitive subpopulations 

are provided in chapter 2 of the 

Proposed RTCR EA (USEPA 2010a). 

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. 

1. Risk to Children, Pregnant Women, 

and the Elderly 

Children and the elderly are 

particularly vulnerable to kidney failure 

(hemolytic uremic syndrome) caused by 

the pathogenic bacterium E. coli 

O157:H7. 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 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, 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. 


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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 2010a) 

discuss this issue qualitatively. 

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 (USEPA 2010e). 

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. Varying the assumptions 

about the percentages of corrective 

actions identified and the effectiveness 

of those actions has a less than linear 

effect on outcomes, and the AIP option 

continues to be less costly than the 

Alternative option under all scenarios 

modeled. Exhibits 5.22a and 5.22b of 

the Proposed RTCR EA (USEPA 2010a) 

provide summaries of the driving model 

parameters and indicate where in the 

proposed RTCR EA the full discussion 

of uncertainty on each parameter is 

contained. 


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Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Proposed Rules 40991 

1According to the Web site 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.’’ 

2Both traditional and enhanced COI approaches 

count the value of the direct medical costs and of 

time lost that would been spent working for a wage, 

but differ in their assessment of the value of time 

lost that would be spent in nonmarket work (e.g., 

housework, yardwork, and raising children) and 

leisure (e.g., recreation, family time, and sleep). 

They also differ in their valuation of (other) 

disutility, which encompasses a range of factors of 

well being, including both inconvenience and any 

pain and suffering. A complete discussion of the 

traditional and enhanced COI approaches can be 

found in Appendix E of the RTCR EA (USEPA 

2010a). 

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 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 2010a)) showed that the 

fundamental conclusions of the 

economic analysis do not change over a 

wide range of assumptions. Both the 

AIP and Alternative options provide 

benefits as compared to the current 

TCR. Varying key assumptions has a 

less than linear effect on outcomes, and 

the AIP option continues to be less 

costly than the Alternative option under 

all scenarios modeled. See section 

5.3.3.1 of the Proposed RTCR EA 

(USEPA 2010a) for details. 

M. Benefit Cost Determination for the 

Proposed RTCR 

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 2010a)) was 

conducted using two example 

pathogens responsible for some 

(unknown) proportion of waterborne 

illnesses in the United States: shiga 

toxin-producing EC O157:H7 1 (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 benefits 

valuations approaches,2 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 

relative to the Alternative 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 benefits valuations 

approaches, respectively. Given the 

large number of potential waterborne 

pathogens shown to occur in PWSs and 

the relatively low net costs of the 

proposed RTCR, EPA believes, as 

discussed in this section and in the 

Proposed RTCR EA (USEPA 2010a), that 

the AIP option is likely to at least break 

even. Chapter 9 of the Proposed RTCR 

EA (USEPA 2010a) 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 (COI) methodology Discount rate 

(percent) 

AIP option Alternative option 

Non-fatal cases 

only 

Fatal cases 

only 1

Non-fatal cases 

only 

Fatal cases 

only 1

E. coli O157:H7: 

Traditional COI .......................................... 3 8,000 1.6 16,000 3.1 

7 8,000 1.5 17,000 3.4 

Enhanced COI .......................................... 3 3,000 1.6 5,000 3.1 

7 3,000 1.5 6,000 3.4 

Salmonella: 

Traditional COI .......................................... 3 65,000 1.6 130,000 3.1 

7 65,000 1.6 141,000 3.4 

Enhanced COI .......................................... 3 10,000 1.6 20,000 3.1 


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EXHIBIT VI–28—ESTIMATED BREAKEVEN THRESHOLD FOR AVOIDED CASES OF E. COLI O157:H7 AND SALMONELLA— 

Continued 

Cost of illness (COI) methodology Discount rate 

(percent) 

AIP option Alternative option 

Non-fatal cases 

only 

Fatal cases 

only 1

Non-fatal cases 

only 

Fatal cases 

only 1

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 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 2010a), 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 2010a). Detailed benefits and cost information is provided in Appendices A and C, respectively, of the Proposed RTCR EA (USEPA 2010a). 

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 corrective action than the 

Alternative option. EPA further 

considered the group of 60,200 TNCWSs 

serving 100 or fewer people and using 

GW, which are the largest subset of 

systems by size and type. This group is 

expected to bear the highest aggregate 

burden under the proposed RTCR 

because of the number of systems in the 

group, but the per system cost of this 

group is relatively low, ($83 annualized 

at 3% discount in 2007$). The two 

incremental analyses (Exhibit VI–30 and 

Exhibit VI–31) 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 2010a). 

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. 


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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 2010a). Detailed benefits and cost information is provided in Appendices A and C, respectively, of the Proposed RTCR EA (USEPA 2010a). 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] 

Regulatory scenario 3% Discount 

rate 

7% Discount 

rate 

1. AIP Incremental Net Costs ($ millions) 1 ............................................................................................................. $5.1 $5.1 

2. AIP Incremental Corrective Actions (L1 & L2) (TNCWS < 101 only) 1 ............................................................... 279 257 

3. AIP Incremental Cost per CA ($) ........................................................................................................................ $18,219 $19,965 

4. Alternative Option Incremental Net Costs ($ millions) 2 ...................................................................................... $8.3 $9.8 

5. Alternative Option Incremental Corrective Actions (L1 & L2) (TNCWS < 101 only) 2 ........................................ 128 145 

6. Alternative Option Incremental Cost per CA ($) ................................................................................................. $64,731 $67,762 

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. 

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 2010a). 

The preferred option for the proposed 

RTCR is the AIP option. The analyses 

performed as part of the Proposed RTCR 

EA (USEPA 2010a) 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 

2010a) 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. The EPA 

Science Advisory Board (SAB) noted in 

its analysis of the EA (described in 

section VII.K of this preamble) that they 

are not generally supportive of 

decreased monitoring, and that overall, 

the Alternative option appears to 

address and protect public health 

sooner in time than the AIP proposed 

implementation. However, EPA 

concluded that the increased costs 

associated with the Alternative option 

are not justified by the increased 

benefits because under the AIP option, 

States could conduct site visits in place 

of increased monitoring and such site 

visits are more protective of public 

health. In particular, the costeffectiveness analysis shows that the 

Alternative option is not as costeffective as the proposed AIP option. 

N. Request for Comment on the 

Economic Analysis 

EPA requests comment on the 

following aspects of the Proposed RTCR 

EA (USEPA 2010a): 

• The EPA Science Advisory Board 

(SAB) noted in its review of the 

Proposed RTCR EA that overall, the 

Alternative option appears to address 

and protect public health sooner in time 

than the AIP proposed implementation. 

The SAB is concerned about decreased 

monitoring in the AIP option, compared 

to the Alternative option. Although the 

AIP option contains less overall 

monitoring than the Alternative option, 

EPA believes that having States 

conducting site visits in place of 

increased monitoring under the AIP 

option is more protective of public 

health. As discussed in this section, 

EPA evaluates the costs and benefits of 

all options and prefers the AIP option 

because the increased costs associated 

with the Alternative option are not 

justified by the increased short term 

benefits. EPA requests comment on 

whether this determination is 

reasonable and how the RTCR may best 

address the SAB’s concern that the 

Alternative option appears to protect 

public health sooner in time than the 

proposed AIP option. 

In addition, the SAB noted in its 

review that measures other than total 

coliform may provide valuable 

supplemental information on the health 

risks of distributed water. The SAB 

provided example measures such as 

water age, biofilm assessment, 

implementation of Best Management 

Practices, indicators that would inform 

the structural and hydraulic integrity of 

distribution system, etc. The TCRDSAC 

also suggested that EPA develop 

measures to evaluate the long-term 

effectiveness of the rule. EPA requests 

comment on the measures that may be 

monitored and tracked to indicate the 

long-term effectiveness of the RTCR and 

how these measures may be 

implemented effectively. 

• Major distribution system 

appurtenances such as storage tanks 

generally have a useful life that is 

accounted for in water system capital 

planning. While the assessments 

conducted under RTCR could identify 

when that useful life has ended, EPA 

assumes the replacement or 

maintenance of appurtenances is part of 

a water system’s operations and 

maintenance activities and the 

associated cost is accounted for in its 

capital planning. During the 

TCRDSAC’s deliberation, EPA worked 

closely with stakeholders to derive this 

assumption and, consistent with the 

discussions of the TCRDSAC regarding 

major structural fixes or replacements, 

EPA’s analysis did not account for these 

costs as part of the cost of the RTCR, 

although such fixes may be undertaken 

to address sanitary defects identified in 

a Level 1 or Level 2 assessment. EPA 


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requests comment on whether the 

assumption is reasonable. Are there 

alternative approaches that could be 

used to address this issue? If so, what 

would be the basis? 

• In calculating the State cost of the 

rule, EPA assumed that, based on 

stakeholder input and the cost of annual 

site visits, only those States that 

currently allow annual monitoring and 

conduct annual site visits under TCR 

would continue under the RTCR. EPA 

requests comment on whether this 

assumption is reasonable. Are there 

alternative approaches that could be 

used to derive a more reasonable 

assumption? If so, what would be the 

basis? 

• In analyzing the potential benefits 

of the proposed RTCR, EPA assumed 

that 10 percent of Level 1 and Level 2 

assessments under the RTCR would lead 

to corrective action above what is 

already occurring under the current 

TCR. This assumption was based on 

conversations with States. However, 

EPA recognizes that information about 

corrective actions conducted under the 

current TCR is limited and requests 

comment on this assumption and any 

information that relates to it. 

• In assessing the benefits of the rule, 

EPA assumed that because Level 2 

assessments would be more 

comprehensive investigations than 

Level 1 assessments, they would 

generally result in finding more 

substantial problems than Level 1 

assessments and would be more 

effective at reducing future occurrences 

of total coliforms and E. coli. 

Specifically, for modeling purposes, 

EPA assumed that, on average, systems 

performing corrective action as a result 

of a Level 1 assessment will experience 

no positive samples for the remainder of 

the year and one additional year, and 

will experience a 50 percent reduction 

in occurrence for three additional years, 

while systems performing corrective 

action as a result of a Level 2 assessment 

will experience no positive sample for 

the remainder of the year and two 

additional years, and a 75 percent 

reduction in occurrence for five 

additional years. EPA requests comment 

on whether these assumptions are 

reasonable, as well as any data or 

experience that commenters may 

provide that bears on the effectiveness 

of corrective action at reducing 

occurrence. Specifically, what 

differences between a Level 2 and Level 

1 assessment would lead the former to 

identify more substantial problems and 

result in greater, longer-lasting 

occurrence reductions? 

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. 

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 2010a). 

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. 

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. 

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 $71.3 million, for an 

average of $23.8 million per year 

(simple average over three years). (Note 

that this is higher than the annualized 

costs for the proposed rule because in 

the EA, the up-front costs that occur in 

the first three years, as well as future 

costs, are annualized over a 25-year time 


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horizon). The average burden per 

response (i.e., the amount of time 

needed for each activity that requires a 

collection of information) is 5.4 hours; 

the average cost per response is $153.4. 

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 2010d) and 

chapter 7 of the EA (USEPA 2010a). 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 type Annual burden 

hours 

Cost 

Annual 

responses Annual labor cost 

Annual operation 

& maintenance 

(O&M) cost 

Annual capital 

cost Total annual cost 

PWSs ............................... 747,848 $20,171,639 $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 2010d). 

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 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 July 14, 2010, a 

comment to OMB is best assured of 

having its full effect if OMB receives it 

by August 13, 2010. 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-forprofit 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. 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 privatelyowned 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 2010a). 

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 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. 

EPA also conducted outreach to small 

entities and convened a Small Business 

Advocacy Review Panel to obtain advice 


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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 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.A.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. 

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 generally not 

significant, as described previously in 

section VII.C and are detailed in the 

Proposed RTCR EA (2010a). 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. 

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. 

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 


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Executive Order 12866. This action’s 

health and risk assessments regarding 

children are contained in section VI.K.1 

of this preamble and in the Proposed 

RTCR EA (USEPA 2010a). 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. 

I. National Technology Transfer and 

Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA), Public Law 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 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. 

The Agency requests comment on 

whether there are any specific 

environmental justice considerations 

that EPA should analyze and consider. 

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 U.S. Department of Health and 

Human Services on the proposed RTCR. 

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. However, they 

noted in their analysis of the EA that 

they are not generally supportive of 

decreased monitoring, and that overall, 

the Alternative option appears to 

address and protect public health 

sooner in time than the AIP proposed 

implementation. The SAB DWC 

recommended that EPA clarify 

rationales for assumptions; expand 

explanations of sensitivity analyses that 

were included; provide further 

justification in those areas in which 

sensitivity analyses were not conducted; 

and collect data after promulgation of 

the rule to allow EPA to better 

understand the public health impacts of 

the RTCR. 

In response to the SAB DWC 

recommendations, EPA conducted 

sensitivity analyses to explore a wider 

range of assumptions regarding the 


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percentage of assessments leading to 

corrective actions and to demonstrate 

that using an annual average for 

occurrence provided results comparable 

to varying the occurrence based on the 

season. EPA also added an exhibit in the 

EA that summarizes all significant 

model parameters and assumptions, 

their influence on variability and 

uncertainty, and their most likely effect 

on benefits or costs. In addition, EPA 

added a request for comment to this 

preamble to obtain suggestions about 

what data should be collected and used 

to better understand the impacts of the 

RTCR. The added exhibits and 

expanded and clarified text can be 

found in the Proposed RTCR EA 

(USEPA 2010a). A copy of the SAB 

report (SAB 2010) 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 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 public notification requirements 

for the GWR as they may also be 

appropriate for the proposed RTCR. EPA 

considered the recommendations from 

NDWAC in developing the public 

notification requirements for the 

proposed rule and is requesting 

comment on these issues (see section 

III.A.7.c of this preamble). 

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. 

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. 

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White Paper Valuing the Benefits of 

Fatal Cancer Risk Reduction. Prepared 

for the Environmental Economics 

Advisory Committee. July 27, 2000. 

EPA–SAB–EEAC–00–013. 

USEPA. 2000b. Stage 2 Microbial and 

Disinfection Byproducts Federal 

Advisory Committee Agreement in 

Principle. 65 FR 83015. (December 29, 

2000). 

USEPA. 2000c. Guidelines for Preparing 

Economic Analyses. US EPA Office of 

the Administrator. September 2000. 

EPA–240–R–00–003. 

USEPA. 2000d. Health Risks of Enteric Viral 

Infections in Children. Office of Science 

and Technology, Washington, DC 

September 30, 2000. EPA–822–R–00– 

010. 

USEPA. 2002. National Primary Drinking 

Water Regulations: Long Term 1 

Enhanced Surface Water Treatment Rule; 

Final Rule. 67 FR 1812. (January 14, 

2002). 

USEPA. 2003. National Primary Drinking 

Water Regulations: Announcement of 

Completion of EPA’s Review of Existing 

Drinking Water Standards. 68 FR 42908. 

(July 18, 2003). 

USEPA. 2004. EPA Microbiological Alternate 

Test Procedure (ATP) Protocol for 

Drinking Water, Ambient Water, and 

Wastewater Monitoring Methods, 

Guidance. EPA 821–B–03–004. 

USEPA. 2005. Manual for the Certification of 

Laboratories Analyzing Drinking Water 

5th Edition. Office of Water. January 

2005. EPA 815–R–05–004. 

USEPA. 2006a. Economic Analysis for the 

Final Ground Water Rule. October 2006. 

EPA–815–R–06.014. 

USEPA. 2006b. Information Collection 

Request for Contaminant Occurrence 

Data in Support of EPA’s Second SixYear Review of National Primary 

Drinking Water Regulations. EPA ICR 

Number 2231.01., OMB Control No. 

2040–NEW. August 2006. 

USEPA. 2006c. National Primary Drinking 

Water Regulations: Ground Water Rule; 

Final Rule. 71 FR 65574. (November 8, 

2006). 

USEPA. 2006d. National Primary Drinking 

Water Regulations: Long Term 2 

Enhanced Surface Water Treatment Rule; 

Final Rule. 71 FR 654. (January 5, 2006). 

USEPA. 2006e. National Primary Drinking 

Water Regulations: Stage 2 Disinfectants 

and Disinfection Byproducts Rule; Final 

Rule. 71 FR 388. (January 4, 2006). 

USEPA. 2007a. Establishment of the Total 

Coliform Rule Distribution System 

Advisory Committee. 72 FR 35869. (June 

29, 2007). 

USEPA. 2007b. The Safe Drinking Water 

Information System—Federal Version 

(SDWIS/FED) data. Available online at 

http://epa.gov/enviro/html/sdwis/. Last 

accessed Apr 2009. 

USEPA. 2008a. Draft Information Collection 

Request for the Microbial Rules. OMB 

Control Number: 2040–0205. EPA 

Tracking Number: 1895.06. September 

2008. 

USEPA. 2008b. Draft Information Collection 

Request for the Public Water System 

Supervision Program. OMB Control 

Number: 2040–0090. EPA Tracking 

Number: 0270.43. 

USEPA. 2008c. US Environmental Protection 

Agency Total Coliform Rule/Distribution 

Systems (TCRDS) Federal Advisory 

Committee Agreement In Principle. 

Available online at http://www.epa.gov// 

safewater/disinfection/tcr/pdfs/tcrdsac/ 

agreementinprinciple_tcrdsac_2008–09– 

18.pdf. Accessed on June 2009. 

USEPA. 2009. National Primary Drinking 

Water Regulations: Airline Drinking 

Water Rule; Final Rule. 74 FR 53590. 

(October 19, 2009). 

USEPA 2010a. Economic Analysis for the 

Proposed Revised Total Coliform Rule. 

EPA–815–R–10–001. 

USEPA. 2010b. Technology and Cost 

Document for the Proposed Revised 

Total Coliform Rule. EPA–815–R–10– 

002. 

USEPA. 2010c. Total Coliform Rule 

Compliance Monitoring Data Quality and 

Completion Report. EPA–815–R–10–003. 

USEPA. 2010d. Information Collection 

Request for the Proposed Revised Total 


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Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Proposed Rules 41001 

Coliform Rule. OMB Control No. 2040– 

AD94. EPA ICR No. 1895.06. 

USEPA. 2010e. Six-Year Review 2 

Contaminant Occurrence Data for the 

Proposed RTCR. Available by request at 

http://www.regulations.gov/as part of the 

Proposed RTCR docket EPA–HQ–OW– 

2008–0878. 

USEPA and WRF. 2009. Memorandum of 

Understanding on the Total Coliform 

Rule/Distribution System Research and 

Information Collection Partnership 

Between the US Environmental 

Protection Agency and the Water 

Research Foundation (WRF). January 27, 

2009. 

van der Kooij, D. 2003. Managing regrowth in 

drinking water distribution systems. In: 

Heterotrophic Plate Counts and 

Drinking-water Safety, The Significance 

of HPCs for Water Quality and Human 

Health. J.V. Cotruvo, M. Exner, C. 

Fricker, and A. Glasmacher. eds. 

London. IWA Publishing. pp.199–232. 

Warren, L. S., R. E. Benoit, and J. A. Jessee. 

1978. Rapid Enumeration of Fecal 

Coliforms in Water by a Colorimetric B– 

Galactosidase Assay. Applied and 

Environmental Microbiology 35(1):136– 

141. 

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, Indian-lands, Radiation 

protection, Reporting and recordkeeping 

requirements, Water supply. 

Dated: June 16, 2010. 

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 variances or exemptions 

from the MCLs for total coliforms and E. 

coli and variances from any of the 

treatment technique requirements of 

subpart H of this part may not be 

granted. 

(b) EPA has stayed the effective date 

of this section relating to the total 

coliform MCL of § 141.63(a) for systems 

that demonstrate to the State that the 

violation of the total coliform MCL is 

due to a persistent growth of total 

coliforms in the distribution system 

rather than fecal or pathogenic 

contamination, a treatment lapse or 

deficiency, or a problem in the 

operation or maintenance of the 

distribution system. This is stayed until 

[DATE THREE YEARS FOLLOWING 

PUBLICATION OF THE FINAL RULE], 

at which time the total coliform MCL is 

no longer effective. 

§ 141.13 [Removed and reserved] 

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 [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 [DATE THREE 

YEARS FOLLOWING PUBLICATION 

OF THE FINAL RULE] is completed, as 

well as analytical method, reporting, 

recordkeeping, public notification, and 

consumer confidence report 

requirements associated with that 

monitoring and testing. After [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 

[DATE THREE YEARS FOLLOWING 

PUBLICATION OF THE FINAL RULE]. 

§ 141.22 [Removed and reserved] 

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 

coliforms and Escherichia coli).

zero. 

(5) Cryptosporidium ........................ zero. 

(6) Escherichia coli (E. coli) ............ zero. 

(b) The MCLG identified in paragraph 

(a)(4) of this section is applicable until 

[DATE THREE YEARS FOLLOWING 

PUBLICATION OF THE FINAL RULE]. 

The MCLG identified in paragraph (a)(6) 

of this section is applicable beginning 

[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 [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 coliformpositive, 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 [DATE THREE YEARS 

FOLLOWING PUBLICATION OF THE 

FINAL RULE], any fecal coliformpositive repeat sample or E. coli-positive 

repeat sample, or any total coliformpositive repeat sample following a fecal 

coliform-positive or E. coli-positive 

routine sample, constitutes a violation 

of the MCL for total coliforms. For 

purposes of the public notification 

requirements in subpart Q of this part, 

this is a violation that may pose an 

acute risk to health. 

(c) Beginning [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 coliformpositive routine sample. 


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(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. 

(d) Until [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 [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; 

(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 [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 [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 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 [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. 

* * * * * 

(c) * * * 

(1) * * * 

(i) Routine monitoring. Until [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 § 141.21. Beginning [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 of this part may use 

the results of residual disinfectant 

concentration sampling conducted 

under § 141.74(b)(6)(i) for unfiltered 

systems or § 141.74(c)(3)(i) for systems 

which filter, in lieu of taking separate 

samples. 

* * * * * 

10. Section 141.153 is amended as 

follows: 

(a) By revising paragraph (d)(4)(vii) 

introductory text. 

(b) By revising paragraph (d)(4)(viii). 

(c) By adding paragraphs (d)(4)(x) and 

(d)(4)(xi). 

§ 141.153 Content of the reports. 

* * * * * 

(d) * * * 

(4) * * * 

(vii) For total coliform analytical 

results until [DATE THREE YEARS 

FOLLOWING PUBLICATION OF THE 

FINAL RULE]: 

* * * * * 

(viii) For fecal coliform until [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 Appendix A to Subpart O of 

Part 141, the table is amended by 

revising the entries for ‘‘Total Coliform 

Bacteria’’ and ‘‘Fecal Coliform and E. 

coli,’’ adding a second entry for ‘‘Total 


srobinson on DSKHWCL6B1PROD with PROPOSALS3
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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 samples are 

positive; (systems that 

collect < 40 samples/ 

month) 1 positive monthly 

sample.

.................... MCL (systems that collect 

≥ 40 samples/month) 5% 

of monthly samples are 

positive; (systems that 

collect < 40 samples/ 

month) 1 positive monthly 

sample.

0 Naturally present in 

the environment.

Coliforms are bacteria that 

are naturally present in 

the environment and are 

used as an indicator that 

other, potentially-harmful, 

bacteria may be present. 

Coliforms were found in 

more samples than allowed and this was a 

warning of potential problems. 

Total Coliform 

Bacteria ‡.

TT ........................................ .................... TT ........................................ N/A Naturally present in 

the environment.

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 

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 coliform-positive 

and either is E. coli-positive or system fails to take 

repeat samples following 

E. coli-positive routine 

sample or system fails to 

analyze total coliformpositive repeat sample for 

E. coli.

.................... 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 

coliform-positive repeat 

sample following an E. 

coli-positive routine sample 

(3) The system fails to take 

all required repeat samples following an E. colipositive routine sample 

(4) The system fails to test 

for E. coli when any repeat sample tests positive 

for total coliform 

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 greater health 

risk for infants, young children, some of the elderly, 

and people with severelycompromised immune 

systems. 


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APPENDIX A TO SUBPART O OF PART 141—REGULATED CONTAMINANTS—Continued 

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 

*******

* * * * * 

† Until [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE]. 

‡Beginning [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE]. 

* * * * * 

12. Section 141.202(a), Table 1, is 

amended by adding a new sentence at 

the end of entry (1) to read as follows: 

§ 141.202 Tier 1 Public Notice—Form, 

manner, and frequency of notice. 

* * * * * 

TABLE 1 TO § 141.202—VIOLATION CATEGORIES AND OTHER SITUATIONS REQUIRING A TIER 1 PUBLIC NOTICE

(1) * * * 

Violation of the MCL for E. coli (as specified in § 141.63(c)); 

* * * * * * * 

13. Section 141.203(b)(2) is revised to 

read as follows: 

§ 141.203 Tier 2 Public Notice—Form, 

manner, and frequency of notice. 

* * * * * 

(b) * * * 

(2) The public water system must 

repeat the notice every three months as 

long as the violation or situation 

persists, unless the primacy agency 

determines that appropriate 

circumstances warrant a different repeat 

notice frequency. In no circumstance 

may the repeat notice be given less 

frequently than once per year. It is not 

appropriate for the primacy agency to 

allow less frequent repeat notice for an 

MCL or treatment technique violation 

under the Total Coliform Rule or 

subpart Y of this part or a treatment 

technique violation under the Surface 

Water Treatment Rule or Interim 

Enhanced Surface Water Treatment 

Rule. It is also not appropriate for the 

primacy agency to allow through its 

rules or policies across-the-board 

reductions in the repeat notice 

frequency for other ongoing violations 

requiring a Tier 2 repeat notice. Primacy 

agency determinations allowing repeat 

notices to be given less frequently than 

once every three months must be in 

writing. 

* * * * * 

14. Section 141.204(a), Table 1, is 

amended by revising entries (4) and (5) 

and adding entry (6) to read as follows: 

§ 141.204 Tier 3 Public Notice—Form, 

manner, frequency of notice. 

(a) * * * 

TABLE 1 TO § 141.204—VIOLATION CATEGORIES AND OTHER SITUATIONS REQUIRING A TIER 3 PUBLIC NOTICE

*******

(4) Availability of unregulated contaminant monitoring results, as required under § 141.207; 

(5) Exceedance of the fluoride secondary maximum contaminant level (SMCL), as required under § 141.208; and 

(6) Reporting violations under subpart Y of 40 CFR part 141. 

* * * * * 

15. Appendix A to subpart Q of Part 

141 is amended by revising entries I.A.1 

and I.A.2 and adding two endnotes to 

read as follows: 

APPENDIX A TO SUBPART Q OF PART 141—NPDWR VIOLATIONS AND OTHER SITUATIONS REQUIRING PUBLIC NOTICE 1

Contaminant 

MCL/MRDL/TT violations 2 Monitoring, testing and reporting 

procedure 

violations 

Tier of public 

notice required Citation Tier of public 

notice required Citation 

I. Violations of National Primary Drinking Water Regulations (NPDWR): 3

A. Microbiological Contaminants 

1.a Total coliform bacteria † .................................................................. 2 141.63(a) 3 141.21(a)–(e) 

1.b Total coliform (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 [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE]. 


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‡Beginning [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE]. 

* * * * * 

16. Appendix B to subpart Q of Part 

141 is amended as follows: 

(a) By revising entries 1a and 1b. 

(b) By adding entries 1e and 1f. 

(c) By adding two endnotes. 

APPENDIX B TO SUBPART Q OF PART 141—STANDARDS HEALTH EFFECTS LANGUAGE FOR PUBLIC NOTIFICATION

Contaminant MCLG;1 mg/L MCL2 mg/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, potentially-harmful, 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 .............. TT 3 ................................ 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 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 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.

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 [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE]. 

‡Beginning [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE]. 

* * * * * 

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 Stateapproved combination of 4-log virus 


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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 

[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 coliformpositive and the sample is not 

invalidated under § 141.853 beginning 

[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 [DATE 

THREE YEARS FOLLOWING 

PUBLICATION OF THE FINAL RULE], 

or collected under §§ 141.854 through 

141.857 beginning [DATE THREE 

YEARS FOLLOWING PUBLICATION 

OF THE FINAL RULE], except as 

provided in paragraph (a)(2)(ii) of this 

section. 

(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 

[DATE THREE YEARS FOLLOWING 

PUBLICATION OF THE FINAL RULE], 

or under § 141.853 beginning [DATE 

THREE YEARS FOLLOWING 

PUBLICATION OF THE FINAL RULE], 

and that the system intends to use for 

representative sampling under this 

paragraph. 

(iii) Until [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 [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 

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 [DATE 

THREE YEARS FOLLOWING 

PUBLICATION OF THE FINAL RULE], 

or under §§ 141.854 through 141.857 

beginning [DATE THREE YEARS 

FOLLOWING PUBLICATION OF THE 

FINAL RULE], must notify the 

wholesale system(s) within 24 hours of 

being notified of the total coliformpositive 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 [DATE THREE 

YEARS FOLLOWING PUBLICATION 

OF THE FINAL RULE], or collected 

under §§ 141.854 through 141.857 

beginning [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 indicator-positive, 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 [DATE THREE 

YEARS FOLLOWING PUBLICATION 

OF THE FINAL RULE], or under 

§§ 141.854 through 141.857 beginning 

[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 [DATE 

THREE YEARS FOLLOWING 

PUBLICATION OF THE FINAL RULE], 

or under §§ 141.854 through 141.857 

beginning [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. 

* * * * * 

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 coliformpositive samples that are not invalidated 

under § 141.21(c) until [DATE THREE 

YEARS FOLLOWING PUBLICATION 

OF THE FINAL RULE], or under 

§ 141.853 beginning [DATE THREE 

YEARS FOLLOWING PUBLICATION 

OF THE FINAL RULE]. Documentation 


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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 [DATE THREE YEARS 

FOLLOWING PUBLICATION OF THE 

FINAL RULE], and under § 141.852 

beginning [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 

§ 141.21(c)(2) until [DATE THREE 

YEARS FOLLOWING PUBLICATION 

OF THE FINAL RULE], or in accordance 

with § 141.853(c) beginning [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 of 

this part serving 1,000 or fewer people. 

141.857 Routine monitoring requirements 

for public water systems serving more 

than 1,000 people. 

141.858 Repeat monitoring and E. coli 

requirements. 

141.859 Coliform treatment technique 

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 [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. 

Seasonal system is a non-community 

water system that is operated in 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 Method 1 Citation 

Total Coliforms ........... Lactose Fermentation Methods ..................... Total Coliform Multiple Tube Fermentation 

Technique.

9221 B.1, B.2 1 2

Presence-Absence (P–A) Coliform Test ........ 9221 D.1, D.2 1 12

Membrane Filtration Methods ........................ Total Coliform Membrane Filter Technique ... 9222 B, C 1 3

Membrane Filtration using MI medium .......... EPA Method 1604 3 4

m-ColiBlue24® Test.3 5

Chromocult.3 6

Enzyme Substrate Methods ........................... Colilert® .......................................................... 9223 B1 7

Colisure® ........................................................ 9223 B1, 7, 8

E*Colite® Test.9

Readycult® Test.10

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 (EC–MUG) ..................... 9222 G.1a(2) 1 13

NA–MUG medium .......................................... 9222 G.1a(1) 1

Membrane Filtration Methods ........................ Membrane Filtration using MI medium .......... EPA Method 1604 3 4

m-ColiBlue24® Test.3 5

Chromocult.3 6

Enzyme Substrate Methods ........................... Colilert® .......................................................... 9223 B1 7

Colisure® ........................................................ 9223 B178

E*Colite® Test.9

Readycult® Test.10


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41008 Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Proposed Rules 

Organism Methodology category Method 1 Citation 

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. 

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/ibr-locations.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 falsepositive rate and false-negative rate for total coliforms, using lactose broth, is less than 10 percent. 3All 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. 4EPA Method 1604: Total Coliforms and Escherichia coli in Water by Membrane Filtration Using a Simultaneous Detection Technique (MI Medium); September 2002, EPA 821–R–02–024. The method is available at http://www.epa.gov/nerlcwww/1604sp02.pdf or from EPA’s Water Resource Center (RC–4100T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. 5The m-ColiBlue24® test is described in the document ‘‘Membrane Filtration Method m-ColiBlue24® Broth, Revision 2, August 17, 1999’’, available from the Hach Company, P.O. Box 389, Loveland, CO 80539. 6The Chromocult test is described in the document ‘‘Chromocult® Coliform Agar Presence/Absence Membrane Filter Test Method for Detection and Identification of Coliform Bacteria and Escherichia coli in Finished Waters,’’ November 2000, Version 1.0, available from EMD Chemicals 

(an affiliate of Merck KGaA, Darmstadt Germany), 480 S. Democrat Road, Gibbstown, NJ 08027–1297. (Telephone (800) 222–0342). 7 Multiple-tube and multi-well enumerative formats for this method are approved for use in presence-absence determination under this regulation. 8 Colisure® results may be read after an incubation time of 24 hours. 9The 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. 

(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 

[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 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 


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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. 

(A) If a repeat sample taken at the 

monitoring location required for 

triggered source water monitoring is E. 

coli-positive, the system has violated the 

E. coli MCL and must also comply with 

§ 141.402(a)(3). If a system 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. coli-positive. 

(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. 

(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 nondistribution 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 coliformpositive sample are also total coliformpositive, 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 coliformnegative, 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-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 coliformnegative. 

(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 coliformpositive 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 


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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 

[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 

[DATE THREE YEARS AFTER 

PUBLICATION OF THE FINAL RULE] 

or unless otherwise directed by the 

State. 

(2) After [DATE THREE YEARS 

AFTER PUBLICATION OF THE FINAL 

RULE], 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 demand or highest 

vulnerability to contamination). The 

seasonal system must collect 

compliance samples during these time 

periods. 

(d) Annual site visits. Beginning no 

later than [DATE FOUR YEARS AFTER 

PUBLICATION OF THE FINAL RULE], 

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 [DATE THREE YEARS 

AFTER PUBLICATION OF THE FINAL 

RULE], the State may reduce the 

monitoring frequency for a welloperated 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 

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. 

(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 have in place or 

adopt one or more additional 

enhancements to the water system 

barriers to contamination in paragraphs 

(h)(2)(i) through (h)(2)(v) of this section. 

(i) Cross connection control, as 

approved by the State. 

(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 

[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 [DATE THREE YEARS 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 


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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 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 coliformnegative. If the State determines that the 

system has corrected the contamination 

problem before the system takes the set 

of repeat samples required in § 141.858, 

and all repeat samples were total 

coliform-negative, the State may waive 

the requirement for additional routine 

monitoring the next month. 

§ 141.855 Routine monitoring 

requirements for community water systems 

serving 1,000 or fewer people using only 

ground water. 

(a) General. (1) The provisions of this 

section apply to community water 

systems using only ground water 

(except ground water under the direct 

influence of surface water, as defined in 

§ 141.2) and serving 1,000 or fewer 

people. 

(2) Following any total coliformpositive 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 [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 [DATE 

THREE YEARS AFTER PUBLICATION 

OF THE FINAL RULE] or unless 

otherwise directed by the State. 

(2) After [DATE THREE YEARS 

AFTER PUBLICATION OF THE FINAL 

RULE], 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. 

(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. 

(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. 


srobinson on DSKHWCL6B1PROD with PROPOSALS3
41012 Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Proposed Rules 

(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 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 coliformnegative. If the State determines that the 

system has corrected the contamination 

problem before the system takes the set 

of repeat samples required in § 141.858, 

and all repeat samples were total 

coliform-negative, the State may waive 

the requirement for additional routine 

monitoring the next month. 

§ 141.856 Routine monitoring 

requirements for subpart H public water 

systems serving 1,000 or fewer people. 

(a) General. (1) The provisions of this 

section apply to subpart H public water 

systems of this part serving 1,000 or 

fewer people. 

(2) Following any total coliformpositive 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 [DATE THREE YEARS 

AFTER PUBLICATION OF THE FINAL 

RULE], all seasonal systems must 

demonstrate completion of a Stateapproved 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 of 

this part (including consecutive 

systems) must monitor monthly. 

Systems may not reduce monitoring. 

(c) Unfiltered subpart H systems. A 

subpart H system of this part that does 

not practice filtration in compliance 

with subparts H, P, T, and W must 

collect at least one total coliform sample 

near the first service connection each 

day the turbidity level of the source 

water, measured as specified in 

§ 141.74(b)(2), exceeds 1 NTU. When 

one or more turbidity measurements in 

any day exceed 1 NTU, the system must 

collect this coliform sample within 24 

hours of the first exceedance, unless the 

State determines that the system, for 

logistical reasons outside the system’s 

control, cannot have the sample 

analyzed within 30 hours of collection 

and identifies an alternative sample 

collection schedule. Sample results from 

this coliform monitoring must be 

included in determining whether the 

coliform treatment technique trigger in 

§ 141.859 has been exceeded. 

§ 141.857 Routine monitoring 

requirements for public water systems 

serving more than 1,000 people. 

(a) General. (1) The provisions of this 

section apply to public water systems 

serving more than 1,000 persons. 

(2) Following any total coliformpositive 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 [DATE THREE YEARS 

AFTER PUBLICATION OF THE FINAL 

RULE], all seasonal systems must 

demonstrate completion of a Stateapproved 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

Population served 

Minimum 

number of 

samples per 

month 

1,001 to 2,500 ...................... 2 

2,501 to 3,300 ...................... 3 

3,301 to 4,100 ...................... 4 

4,101 to 4,900 ...................... 5 

4,901 to 5,800 ...................... 6 

5,801 to 6,700 ...................... 7 

6,701 to 7,600 ...................... 8 

7,601 to 8,500 ...................... 9 

8,501 to 12,900 .................... 10 

12,901 to 17,200 .................. 15 

17,201 to 21,500 .................. 20 

21,501 to 25,000 .................. 25 

25,001 to 33,000 .................. 30 

33,001 to 41,000 .................. 40 

41,001 to 50,000 .................. 50 

50,001 to 59,000 .................. 60 

59,001 to 70,000 .................. 70 

70,001 to 83,000 .................. 80 

83,001 to 96,000 .................. 90 

96,001 to 130,000 ................ 100 

130,001 to 220,000 .............. 120 

220,001 to 320,000 .............. 150 

320,001 to 450,000 .............. 180 

450,001 to 600,000 .............. 210 

600,001 to 780,000 .............. 240 

780,001 to 970,000 .............. 270 

970,001 to 1,230,000 ........... 300 


srobinson on DSKHWCL6B1PROD with PROPOSALS3
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TOTAL COLIFORM MONITORING FREQUENCY FOR PUBLIC WATER SYSTEMS SERVING MORE THAN 1,000 

PEOPLE—Continued 

Population served 

Minimum 

number of 

samples per 

month 

1,230,001 to 1,520,000 ........ 330 

1,520,001 to 1,850,000 ........ 360 

1,850,001 to 2,270,000 ........ 390 

2,270,001 to 3,020,000 ........ 420 

3,020,001 to 3,960,000 ........ 450 

3,960,001 or more ................ 480 

(c) Unfiltered subpart H systems. A 

subpart H system of this part that does 

not practice filtration in compliance 

with subparts H, P, T, and W must 

collect at least one total coliform sample 

near the first service connection each 

day the turbidity level of the source 

water, measured as specified in 

§ 141.74(b)(2), exceeds 1 NTU. When 

one or more turbidity measurements in 

any day exceed 1 NTU, the system must 

collect this coliform sample within 24 

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 noncommunity water systems using only 

ground water (and not ground water 

under the direct influence of surface 

water) serving 1,000 or fewer people in 

some months and more than 1,000 

persons in other months. In months 

when more than 1,000 persons are 

served, the systems must monitor at the 

frequency specified in paragraph (a) of 

this section. In months when 1,000 or 

fewer people are served, the State may 

reduce the monitoring frequency, in 

writing, to a frequency allowed under 

§ 141.854 for a similarly situated system 

that always serves 1,000 or fewer 

people, taking into account the 

provisions in § 141.854(e) through (g). 

§ 141.858 Repeat monitoring and E. coli 

requirements. 

(a) Repeat monitoring. (1) If a sample 

taken under §§ 141.854 though 141.857 

is total coliform-positive, 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 

three-day 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) The system must collect an 

additional set of repeat samples in the 

manner specified in paragraphs (a)(1) 

through (a)(3) of this section if one or 

more repeat samples in the current set 

of repeat samples is total coliformpositive. The system must collect the 

additional set of repeat samples within 

24 hours of being notified of the positive 

result, unless the State extends the limit 

as provided in paragraph (a)(1) of this 

section. The system must continue to 

collect additional sets of repeat samples 

until either total coliforms are not 

detected in one complete set of repeat 

samples or the system determines that a 

coliform treatment technique trigger has 

been exceeded as a result of a repeat 

sample being total coliform-positive and 

notifies the State. If a trigger identified 

in § 141.859 is exceeded as a result of 

a routine sample being total coliformpositive, systems are required to 

conduct only one round of repeat 

monitoring for each total coliformpositive routine sample. 

(4) After a system collects a routine 

sample and before it learns the results 

of the analysis of that sample, if it 

collects another routine sample(s) from 

within five adjacent service connections 

of the initial sample, and the initial 

sample, after analysis, is found to 

contain total coliforms, then the system 

may count the subsequent sample(s) as 

a repeat sample instead of as a routine 

sample. 

(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. 

(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 coliform-positive 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. colipositive 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 coliformpositive 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. 


srobinson on DSKHWCL6B1PROD with PROPOSALS3
41014 Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Proposed Rules 

(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 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. 

(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 coliformpositive 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. 

(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 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 of 

this part. A system must notify the State 

no later than the end of the next 

business day after it learns of an E. colipositive 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 of this part. 

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 


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public in accordance with subpart Q of 

this part. 

(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 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 of this chapter and 

with the limits specified in subpart Y of 

this chapter. 

* * * * * 

(10) Records of each of the following 

decisions made pursuant to the 

provisions of subpart Y of part 141 must 

be made in writing and retained by the 

State. 

(i) Records of the following decisions 

or activities must be retained for five 

years. 

(A) Sections 141.858(a), 141.853(b)(2), 

141.856(c), and 141.857(c) of this 

chapter—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 of this part to collect a total 

coliform sample following a turbidity 

measurement exceeding 1 NTU. 

(B) Sections 141.854(j) and 141.855(f) 

of this chapter—Any decision to allow 

a system to waive the requirement for 

three routine samples the month 

following a total coliform-positive 

sample. The record of the waiver 

decision must contain all the items 

listed in those sections. 

(C) Section 141.853(c) of this 

chapter—Any decision to invalidate a 

total coliform-positive sample. If the 

decision to invalidate a total coliformpositive sample as provided in 

§ 141.853(c)(1) of this chapter is made, 

the record of the decision must contain 

all the items listed in that section. 

(D) Section 141.859 of this chapter— 

Completed and approved subpart Y 

assessments, including reports from the 

system that corrective action has been 

completed as required by § 141.861(a)(2) 

of this chapter. 

(ii) Records of each of the following 

decisions must be retained in such a 

manner so that each system’s current 

status may be determined: 

(A) Section 141.855(d) of this 

chapter—Any decision to reduce the 

total coliform monitoring frequency for 

a community water system serving 

1,000 or fewer people to less than once 

per month, as provided in § 141.855(d) 

of this chapter, including what the 

reduced monitoring frequency is. A 

copy of the reduced monitoring 

frequency must be provided to the 

system. 

(B) Section 141.854(e) of this 

chapter—Any decision to reduce the 

total coliform monitoring frequency for 

a non-community water system using 

only ground water and serving 1,000 or 

fewer people to less than once per 

quarter, as provided in § 141.854(e) of 

this chapter, including what the 

reduced monitoring frequency is. A 

copy of the reduced monitoring 

frequency must be provided to the 

system. 

(C) Section 141.857(d) of this 

chapter—Any decision to reduce the 

total coliform monitoring frequency for 

a non-community water system using 

only ground water and serving more 

than 1,000 persons during any month 

the system serves 1,000 or fewer people, 

as provided in § 141.857(d) of this 

chapter. A copy of the reduced 

monitoring frequency must be provided 

to the system. 

(D) Section 141.858(b)(2) of this 

chapter—Any decision to allow a 

system to forgo E. coli testing of a total 

coliform-positive sample if that system 

assumes that the total coliform-positive 

sample is E. coli-positive. 

* * * * * 

23. Section 142.15 is amended by 

adding paragraph (c)(3) to read as 

follows: 

§ 142.15 Reports by States. 

* * * * * 

(c) * * * 

(3) Total coliforms under subpart Y. A 

list of systems that the State is allowing 

to monitor less frequently than once per 

month for community water systems or 

less frequently than once per quarter for 

non-community water systems as 

provided in §§ 141.855 and 141.854 of 

this chapter, including the applicable 

date of the reduced monitoring 

requirement for each system. 

* * * * * 

24. Section 142.16 is amended by 

adding a new paragraph (q) to read as 

follows: 

§ 142.16 Special primacy requirements. 

* * * * * 

(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. 

(A) Elements of Level 1 and Level 2 

assessments. This must include an 

explanation of how the State will ensure 


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41016 Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Proposed Rules 

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. 

(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. 

25. Section 142.63 is amended by 

revising paragraph (b) to read as follows: 

§ 142.63 Variances and exemptions from 

the maximum contaminant level for total 

coliforms. 

* * * * * 

(b) EPA has stayed this section as it 

relates to the total coliform MCL of 

§ 141.63(a) of this chapter for systems 

that demonstrate to the State that the 

violation of the total coliform MCL is 

due to a persistent growth of total 

coliforms in the distribution system 

rather than fecal or pathogenic 

contamination, a treatment lapse or 

deficiency, or a problem in the 

operation or maintenance of the 

distribution system. This stay is 

applicable until [DATE THREE YEARS 

FOLLOWING PUBLICATION OF THE 

FINAL RULE], at which time the total 

coliform MCL is no longer applicable. 

[FR Doc. 2010–15205 Filed 7–13–10; 8:45 am] 

BILLING CODE 6560–50–P 


srobinson on DSKHWCL6B1PROD with PROPOSALS3