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[Federal Register Volume 78, Number 30 (Wednesday, February 13, 2013)]
[Rules and Regulations]
[Pages 10269-10365]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31205]

[[Page 10269]]

Vol. 78

Wednesday,

No. 30

February 13, 2013

Part II

Environmental Protection Agency

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40 CFR Parts 141 and 142

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

Federal Register / Vol. 78 , No. 30 / Wednesday, February 13, 2013 / 
Rules and Regulations

[[Page 10270]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 141 and 142

[EPA-HQ-OW-2008-0878; FRL-9684-8]
RIN 2040-AD94

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is 
finalizing revisions to the 1989 Total Coliform Rule (TCR). The Revised 
Total Coliform Rule (RTCR) offers a meaningful opportunity for greater 
public health protection beyond the 1989 TCR. Under the RTCR there is 
no longer a monthly maximum contaminant level (MCL) violation for 
multiple total coliform detections. Instead, the revisions require 
systems that have an indication of coliform contamination in the 
distribution system to assess the problem and take corrective action 
that may reduce cases of illnesses and deaths due to potential fecal 
contamination and waterborne pathogen exposure. This final rule also 
updates provisions in other rules that reference analytical methods and 
other requirements in the 1989 TCR (e.g., Public Notification and 
Ground Water Rules). These revisions are in accordance with the 1996 
Safe Drinking Water Act (SDWA) Amendments, which require EPA to review 
and revise, as appropriate, each national primary drinking water 
regulation no less often than every six years. These revisions also 
conform with the SDWA provision that requires any revision to 
``maintain, or provide for greater, protection of the health of 
persons.'' As with the 1989 TCR, the RTCR applies to all public water 
systems.

DATES: This final rule is effective on April 15, 2013. For judicial 
purposes, this final rule is promulgated as of February 13, 2013. The 
compliance date for the rule requirements is April 1, 2016. The 
incorporation by reference of certain publications listed in the rule 
is approved by the Director of the Federal Register (FR) as of April 
15, 2013.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. EPA-HQ-OW-2008-0878. All documents in the docket are listed on the 
http://www.regulations.gov Web site. Although listed in the index, some 
information is not publicly available, e.g., Confidential Business 
Information or other information whose disclosure is restricted by 
statute. Certain other material, such as copyrighted material, is not 
placed on the Internet and will be publicly available only in hard copy 
form. Publicly available docket materials are available either 
electronically through http://www.regulations.gov or in hard copy at 
the Water Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. 
NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 
4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for the Water Docket is (202) 566-2426.

FOR FURTHER INFORMATION CONTACT: Sean Conley, Standards and Risk 
Management Division, Office of Ground Water and Drinking Water (MC-
4607M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460; telephone number: (202) 564-1781; email address: 
conley.sean@epa.gov. For general information, contact the Safe Drinking 
Water Hotline, telephone number: (800) 426-4791. The Safe Drinking 
Water Hotline is open Monday through Friday, excluding legal holidays, 
from 10 a.m. to 4 p.m. Eastern time.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Regulated Categories and Entities

    Entities potentially regulated by the RTCR are all public water 
systems (PWSs). Regulated categories and entities include the 
following:

------------------------------------------------------------------------
                Category                  Examples of regulated entities
------------------------------------------------------------------------
Industry...............................  Privately-owned community water
                                          systems (CWSs), transient non-
                                          community water systems
                                          (TNCWSs), and non-transient
                                          non-community water systems
                                          (NTNCWSs).
Federal, State, Tribal, and local        Publicly-owned CWSs, TNCWSs,
 governments.                             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 Sec.  141.2 and the section 
entitled ``Coverage'' in Sec.  141.3 in title 40 of the Code of Federal 
Regulations (CFR), and the applicability criteria in Sec.  141.851(b) 
of this rule. If you have questions regarding the applicability of this 
action to a particular entity, consult the person listed in the 
preceding FOR FURTHER INFORMATION CONTACT section.

B. Copies of This Document and Other Related Information

    This document is available for download at [INSERT WEBSITE 
ADDRESS]. For other related information, see preceding discussion on 
docket. EPA also prepared a Response to Comments Document that 
addresses the comments received during the comment period (to access 
this document, search for Docket ID No. EPA-HQ-OW-2008-0878 in 
www.regulations.gov).

C. Executive Summary

    EPA is finalizing the Revised Total Coliform Rule (RTCR). The RTCR 
maintains the purpose of the 1989 Total Coliform Rule (TCR) to protect 
public health by ensuring the integrity of the drinking water 
distribution system and monitoring for the presence of microbial 
contamination. EPA anticipates greater public health protection under 
the RTCR, as it requires public water systems (PWSs) that are 
vulnerable to microbial contamination to identify and fix problems, and 
it establishes criteria for systems to qualify for and stay on reduced 
monitoring, thereby providing incentives for improved water system 
operation.
    The RTCR, as with the 1989 TCR, is the only microbial drinking 
water regulation that applies to all PWSs. Systems are required to meet 
a legal limit (i.e., maximum contaminant level (MCL)) for E. coli, as 
demonstrated by required monitoring. The RTCR specifies the frequency 
and timing of the microbial testing by water systems based on 
population served, system type, and source water type. The rule also 
requires public notification when

[[Page 10271]]

there is a potential health threat as indicated by monitoring results, 
and when the system fails to identify and fix problems as required.
    The entities potentially affected by the RTCR are PWSs that are 
classified as community water systems (CWSs) (e.g., systems that 
provide water to year-round residents in places like homes or apartment 
buildings) or non-community water systems (NCWSs) (e.g., systems that 
provide water to people in locations such as schools, office buildings, 
restaurants, etc.); State primacy agencies; and local and tribal 
governments. The RTCR applies to approximately 155,000 PWSs that serve 
approximately 310 million (M) individuals.
    The RTCR establishes a health goal (maximum contaminant level goal, 
or MCLG) and an MCL for E. coli, a more specific indicator of fecal 
contamination and potential harmful pathogens than total coliforms. EPA 
replaces the MCLG and MCL for total coliforms with a treatment 
technique for coliforms that requires assessment and corrective action. 
Many of the organisms detected by total coliform methods are not of 
fecal origin and do not have any direct public health implication.
    Under the treatment technique for coliforms, total coliforms serve 
as an indicator of a potential pathway of contamination into the 
distribution system. A PWS that exceeds a specified frequency of total 
coliform occurrence must conduct an assessment to determine if any 
sanitary defects exist (a sanitary defect is defined by the RTCR as a 
``defect that could provide a pathway of entry for microbial 
contamination into the distribution system or that is indicative of a 
failure or imminent failure of a barrier that is already in place''); 
if any are found, the system must correct them. In addition, under the 
treatment technique requirements, a PWS that incurs an E. coli MCL 
violation must conduct an assessment and correct any sanitary defects 
found.
    The RTCR links monitoring frequency to compliance monitoring 
results and system performance. It provides criteria that well-operated 
small systems must meet to qualify for and stay on reduced monitoring. 
It requires increased monitoring for high-risk small systems with 
unacceptable compliance history. It also requires some new monitoring 
requirements for seasonal systems (such as state and national parks).
    The RTCR eliminates public notification requirements based only on 
the presence of total coliforms. Total coliforms in the distribution 
system may indicate a potential pathway for contamination but by 
themselves do not indicate a health threat. Instead, the RTCR requires 
public notification when an E. coli MCL violation occurs, indicating a 
potential health threat, or when a PWS fails to conduct the required 
assessment and corrective action.
    EPA believes that the provisions of the RTCR will improve public 
health protection by requiring assessment and corrective action and 
providing incentives for improved operation. The estimated net 
incremental cost of the RTCR is $14 million annually at either a three 
or seven percent discount rate. This represents total increased costs 
relative to 1989 TCR provisions. PWSs are estimated to incur 
approximately 97 percent of the rule's net annualized present value 
costs at the three percent discount rate. States and other primacy 
agencies incur the remaining costs.

Abbreviations Used in This Document

AGI--Acute Gastrointestinal Illness
AIDS--Acquired Immune Deficiency Syndrome
AIP--Agreement in Principle
AWWA--American Water Works Association
ATP--Alternate Test Procedure
BAT--Best Available Technology
C--Celsius
CCR--Consumer Confidence Report
CDC--Centers for Disease Control and Prevention
CFR--Code of Federal Regulations
COI--Cost of Illness
CWS--Community Water System
DBP--Disinfection Byproduct
DWC--Drinking Water Committee
EA--Economic Analysis
EC-MUG--EC Medium with MUG
EPA--United States Environmental Protection Agency
ERS--Economic Research Service
ETV--Environmental Technology Verification
FR--Federal Register
GWR--Ground Water Rule
GWUDI--Ground Water Under the Direct Influence of Surface Water
HRRCA--Health Risk Reduction and Cost Analysis
HUS--Hemolytic Uremic Syndrome
ICR--Information Collection Request
IESWTR--Interim Enhanced Surface Water Treatment Rule
M--Million
MCL--Maximum Contaminant Level
MCLG--Maximum Contaminant Level Goal
mg/L--Milligrams per Liter
ml--Milliliters
MRDL--Maximum Residual Disinfectant Level
MUG--4-methylumbelliferyl-Beta-D-glucuronide
NCWS--Non-community Water System
NDWAC--National Drinking Water Advisory Council
NPDWR--National Primary Drinking Water Regulation
NTNCWS--Non-Transient Non-Community Water System
NTU--Nephelometric Turbidity Unit
OMB--Office of Management and Budget
O&M--Operation and Maintenance
PN--Public Notification
PWS--Public Water System
RFA--Regulatory Flexibility Act
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
SWTR--Surface Water Treatment Rule
TCR--Total Coliform Rule
TCRDSAC--Total Coliform Rule/Distribution System Advisory Committee
TMF--Technical, Managerial, and Financial
TNCWS--Transient Non-Community Water System
TWG--Technical Work Group
T&C--Technology and Cost
US--United States
UV--Ultraviolet

Table of Contents

I. General Information
    A. Regulated Categories and Entities
    B. Copies of This Document and Other Related Information
    C. Executive Summary
II. Background
    A. Statutory Authority
    B. Purpose of the Rule
    C. Rule Development
    1. Total Coliform Rule Distribution System Advisory Committee 
(TCRDSAC)
    2. Stakeholder Involvement
    D. Public Health Concerns Addressed by the Revised Total 
Coliform Rule
    1. Public Health Concerns, Fecal Contamination, and Waterborne 
Pathogens
    2. Indicators
    3. Occurrence of Fecal Contamination and Waterborne Pathogens
III. Requirements of the Revised Total Coliform Rule
    A. RTCR Definitions
    1. Assessment
    2. Clean Compliance History
    3. Sanitary Defect
    4. Seasonal Systems
    B. Rule Construct: MCLG and MCL for E. coli and Coliform 
Treatment Technique
    1. MCLG and MCL
    2. Coliform Treatment Technique
    C. Monitoring
    1. Requirements
    2. Key Issues Raised
    D. Repeat samples
    1. Requirements
    2. Key Issues Raised
    E. Coliform Treatment Technique
    1. Coliform Treatment Technique Triggers
    2. Assessment
    3. Corrective Action
    F. Violations
    1. Requirements
    2. Key Issues Raised

[[Page 10272]]

    G. Providing Notification and Information to the Public
    1. Requirements
    2. Key Issues Raised
    H. Reporting and Recordkeeping
    1. Requirements
    2. Key Issues Raised
    I. Analytical Methods
    1. AIP-Related Method Issues
    2. Other Method Issues
    J. Systems Under EPA Direct Implementation
    K. Compliance Date
IV. Other Elements of the Revised Total Coliform Rule
    A. Best Available Technology
    1. Requirements
    2. Key Issues Raised
    B. Variances and Exemptions
    1. Requirements
    2. Key Issues Raised
    C. Revisions to Other NPDWRs as a Result of the RTCR
    D. Storage Facility Inspection
V. State Implementation
    A. Primacy
    1. Requirements
    2. Key Issues Raised
    B. State Recordkeeping and Reporting and SDWIS
    1. Recordkeeping
    2. Reporting
    3. SDWIS
    4. Key Issues Raised
VI. Economic Analysis (Health Risk Reduction and Cost Analysis)
    A. Regulatory Options Considered
    B. Major Sources of Data and Information Used in Supporting 
Analyses
    1. Safe Drinking Water Information System Federal version data
    2. Six-Year Review 2 data
    3. Other information sources
    C. Occurrence and Predictive Modeling
    1. Model Used for PWSs Serving  4,100 People
    D. Baseline Profiles
    E. Anticipated Benefits of the RTCR
    1. Relative Risk Analysis
    2. Changes in Violation Rates and Corrective Actions
    3. Nonquantifiable Benefits
    F. Anticipated Costs of the RTCR
    1. Total Annualized Present Value Costs
    2. PWS Costs
    3. State Costs
    4. Nonquantifiable Costs
    G. Potential Impact of the RTCR on Households
    H. Incremental Costs and Benefits
    I. Benefits From Simultaneous Reduction of Co-occurring 
Contaminants
    J. Change in Risk From Other Contaminants
    K. Effects of Fecal Contamination and/or Waterborne Pathogens on 
the General Population and Sensitive Subpopulations
    1. Risk to Children, Pregnant Women, and the Elderly
    2. Risk to Immunocompromised Persons
    L. Uncertainties in the Benefit and Cost Estimates for the RTCR
    1. Inputs and Their Uncertainties
    2. Sensitivity Analysis
    M. Benefit Cost Determination for the RTCR
    N. Comments Received in Response to EPA's Requests for Comment
    1. SAB's Concerns
    2. Costs of Major Distribution System Appurtenances
    3. Annual Monitoring and Annual Site Visits
    4. Effectiveness of Assessments
    O. Other Comments Received by EPA
    1. Quantifying Health Benefits
    2. Return to Reduced Monitoring
    3. Shift of State Resources
    4. State burden
VII. Statutory and Executive Order Review
    A. Executive Order 12866: Regulatory Planning and Review and 
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From 
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect 
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address 
Environmental Justice in Minority Populations and Low-Income 
Populations
    K. Consultations With the Science Advisory Board, National 
Drinking Water Advisory Council, and the Secretary of Health and 
Human Services
    L. Considerations of Impacts on Sensitive Subpopulations as 
Required by Section 1412(b)(3)(C)(i)(V) of the 1996 Amendments of 
the Safe Drinking Water Act (SDWA)
    M. Effect of Compliance with the RTCR on the Technical, 
Financial, and Managerial Capacity of Public Water Systems
    N. Congressional Review Act
VIII. References

II. Background

A. Statutory Authority

    The Safe Drinking Water Act (SDWA) requires the EPA to review and 
revise, as appropriate, each existing national primary drinking water 
regulation (NPDWR) no less often than every six years (SDWA section 
1412(b)(9), 42 U.S.C. 300g-1(b)(9)). In 2003, EPA completed its review 
of the 1989 TCR (USEPA 1989a, 54 FR 27544, June 29, 1989) and 68 NPDWRs 
for chemicals that were promulgated prior to 1997 (USEPA 2003, 68 FR 
42908, July 18, 2003). The purpose of the review was to identify new 
health risk assessments, changes in technology, and other factors that 
would provide a health-related or technological basis to support a 
regulatory revision that would maintain or improve public health 
protection. In the Six-Year Review 1 determination published in July 
2003 (USEPA 2003, 68 FR 42908, July 18, 2003), EPA stated its intent to 
revise the 1989 TCR.

B. Purpose of the Rule

    EPA promulgated the 1989 TCR to decrease the risk of waterborne 
illness. Among all SDWA rules promulgated for preventing waterborne 
illness, only the TCR applies to all PWSs, making the rule an essential 
component of the multi-barrier approach in public health protection 
against endemic and epidemic disease. In combination with the other 
SDWA rules (e.g., the Ground Water Rule (GWR) (USEPA 2006c, 71 FR 
65574, November 8, 2006) and the suite of surface water treatment rules 
(USEPA 1989b; USEPA 1998b; USEPA 2002; USEPA 2006d)), the RTCR will 
better address the 1989 TCR objectives and enhance the multi-barrier 
approach to protecting public health, especially with respect to small 
ground water PWSs.
    In recent years, the number of violations under the 1989 TCR have 
remained relatively steady, as shown and discussed in Exhibit 4.11 and 
Appendix G of the Economic Analysis for the Final Revised Total 
Coliform Rule (RTCR EA) (USEPA 2012a). EPA believes that this is 
reflective of a steady state among PWSs complying with the 1989 TCR and 
any improvements likely to occur under that rule have largely been 
achieved. In outlining recommendations for further reductions in 
occurrence, EPA and the Total Coliform Rule Distribution System 
Advisory Committee (TCRDSAC) developed an Agreement in Principle (AIP) 
(USEPA 2008c), which became the basis of the proposed and final RTCR. 
See section II.C.1 of this preamble, Total Coliform Distribution System 
Advisory Committee (TCRDSAC), for more information about the TCRDSAC 
and the AIP.
    The RTCR aims for greater public health protection than the 1989 
TCR in a cost-effective manner by: (1) Maintaining the objectives of 
the 1989 TCR (i.e., to evaluate the effectiveness of treatment, to 
determine the integrity of the distribution system, and to signal the 
possible presence of fecal contamination); (2) reducing the potential 
pathways of contamination into the distribution system (see section 
II.D of this preamble, Public Health Concerns Addressed by the Revised 
Total Coliform Rule); (3) using the optimal indicator for the intended 
objectives (i.e., using total coliforms as an indicator of system 
operation and

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condition rather than an immediate public health concern and using E. 
coli as a fecal indicator (see sections II.D, Public Health Concerns 
Addressed by the Revised Total Coliform Rule, and III.B, Rule 
Construct: MCLG and MCL for E. coli and Coliform Treatment Technique, 
of this preamble)); (4) requiring more stringent standards than those 
of the 1989 TCR for systems to qualify for reduced monitoring (see 
sections III.C.1.b.iii, Reduced monitoring, and III.C.1.c.iii, Reduced 
monitoring, of this preamble); and (5) requiring systems that may be 
vulnerable to contamination, as indicated by their monitoring results 
and by the nature of their operation (e.g., seasonal systems), to 
monitor more frequently and have in place procedures that will minimize 
the incidence of contamination (e.g., requiring start-up procedures for 
seasonal systems) (see sections III.C.1.b.iv, Increased monitoring, 
III.C.1.c.iv, Requirements for returning to monthly monitoring, and 
III.C.1.f, Seasonal systems, of this preamble). EPA, therefore, 
anticipates greater public health protection under the RTCR compared to 
the 1989 TCR because of the RTCR's more preventive approach to 
identifying and fixing problems that affect or may affect public 
health.

C. Rule Development

1. Total Coliform Rule Distribution System Advisory Committee (TCRDSAC)
    The revisions to the 1989 TCR are primarily based on the 
recommendations of the Total Coliform Rule Distribution System Advisory 
Committee (``TCRDSAC'' or the ``advisory committee''). EPA established 
the TCRDSAC in June 2007 in accordance with the provisions of the 
Federal Advisory Committee Act, 5 U.S.C. App.2, 9(c), to provide 
recommendations to EPA on revisions to the 1989 TCR and on what 
information about distribution system issues is needed to better 
understand and address possible public health impacts from potential 
degradation of drinking water quality in distribution systems (USEPA 
2007a, 72 FR 35869, June 29, 2007).
    All advisory committee members agreed to a set of recommendations 
and signed a final Agreement in Principle (AIP) in September 2008. 
Pursuant to the AIP, EPA on July 14, 2010 proposed revisions to the 
1989 TCR (USEPA 2010a, 75 FR 40926, July 14, 2010) that, to the maximum 
extent consistent with EPA's legal obligations, had the same substance 
and effect as the elements of the AIP. The AIP and details about the 
advisory committee can be found at EPA's Web site at http://water.epa.gov/lawsregs/rulesregs/sdwa/tcr/regulation_revisions_tcrdsac.cfm.
2. Stakeholder Involvement
    In accordance with one of the recommendations of the TCRDSAC, EPA 
held two annual stakeholder meetings, prior to publishing the proposed 
revisions, to which all advisory committee members and the public at 
large were invited. In April 2009 and May 2010, EPA held these 
stakeholder meetings to provide updates and an opportunity for 
stakeholders to provide feedback on the development of a proposed RTCR 
that had the same substance and effect as the recommendations in the 
AIP.
    EPA proposed the RTCR on July 14, 2010 (USEPA 2010a, 75 FR 40926, 
July 14, 2010) and requested public comment. EPA received approximately 
150 comment letters on the proposal and considered the comments in 
making revisions to the final RTCR. Key issues raised by the commenters 
are discussed in their corresponding sections of this preamble. A 
Response to Comments Document is available in the docket of the RTCR 
(search for Docket ID No. EPA-HQ-OW-2008-0878 in www.regulations.gov).
    During the public comment period for the proposed RTCR, EPA also 
held several meetings to solicit and provide the public with 
information about the provisions of the proposed rule. In addition to 
consulting with the advisory committee and holding stakeholder 
meetings, EPA consulted with specific stakeholders such as the National 
Drinking Water Advisory Council (NDWAC), the Science Advisory Board 
(SAB), and Tribal representatives, among others. These consultations 
are discussed in section VII of this preamble, Statutory and Executive 
Order Review.

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

1. Public Health Concerns, Fecal Contamination, and Waterborne 
Pathogens
    The RTCR aims to increase public health protection through the 
reduction of potential pathways of entry for fecal contamination into 
the distribution system. Since these potential pathways represent 
vulnerabilities in the distribution system whereby fecal contamination 
and/or waterborne pathogens, including bacteria, viruses and parasitic 
protozoa could possibly enter the system, the reduction of these 
pathways in general should lead to reduced exposure and associated risk 
from these contaminants. Fecal contamination and waterborne pathogens 
can cause a variety of illnesses, including acute gastrointestinal 
illness (AGI) with diarrhea, abdominal discomfort, nausea, vomiting, 
and other symptoms. Most AGI cases are of short duration and result in 
mild illness. Other more severe illnesses caused by waterborne 
pathogens include hemolytic uremic syndrome (HUS) (kidney failure), 
hepatitis, and bloody diarrhea (WHO 2004). Chronic disease such as 
irritable bowel syndrome, renal impairment, hypertension, 
cardiovascular disease and reactive arthritis can result from infection 
by a waterborne agent (Clark et al. 2008; Clark et al. 2010; Moorin et 
al. 2010).
    When humans are exposed to and infected by waterborne enteric 
pathogens, the pathogens become capable of reproducing in the 
gastrointestinal tract. As a result, healthy humans shed pathogens in 
their feces for a period ranging from days to weeks. This shedding of 
pathogens often occurs in the absence of any signs of clinical illness. 
Regardless of whether a pathogen causes clinical illness in the person 
who sheds it in his or her feces, the pathogen being shed may infect 
other people directly by person-to-person spread, contact with 
contaminated surfaces, and other means referred to as secondary spread. 
As a result, waterborne pathogens that are initially waterborne may 
subsequently infect other people through a variety of routes (WHO 
2004). Sensitive subpopulations are at greater risk from waterborne 
disease than the general population (Gerba et al. 1996). For a 
discussion of sensitive subpopulations, see section VII.L of this 
preamble, Impacts on Sensitive Subpopulations as Required by Section 
1412(b)(3)(c)(i)(V) of the 1996 Amendments of the Safe Drinking Water 
Act (SDWA).
2. Indicators
    Total coliforms are a group of closely related bacteria that, with 
a few exceptions, are not harmful to humans. Coliforms are abundant in 
the feces of warm-blooded animals, but can also be found in aquatic 
environments, in soil, and on vegetation. Coliform bacteria may be 
transported to surface water by run-off or to ground water by 
infiltration. Total coliforms are common in ambient water and may be 
injured by environmental stresses such as lack of nutrients, and water 
treatments such as chlorine disinfection, in a manner similar to most 
bacterial pathogens and

[[Page 10274]]

many viral enteric pathogens (including fecal pathogens). EPA considers 
total coliforms to be a useful indicator that a potential pathway 
exists through which fecal contamination can enter the distribution 
system. This is because the absence (versus the presence) of total 
coliforms in the distribution system indicates a reduced likelihood 
that fecal contamination and/or waterborne pathogens are occurring in 
the distribution system.
    Under the 1989 TCR, each total coliform-positive sample is assayed 
for either fecal coliforms or E. coli. Fecal coliform bacteria are a 
subgroup of total coliforms that traditionally have been associated 
with fecal contamination. Since the promulgation of the 1989 TCR, more 
information and understanding of the suitability of fecal coliform and 
E. coli as indicators have become available. Study has shown that the 
fecal coliform assay is imprecise and too often captures bacteria that 
do not originate in the human or mammal gut (Edberg et al. 2000). On 
the other hand, E. coli is a more restricted group of coliform bacteria 
that almost always originate in the human or animal gut (Edberg et al. 
2000). Thus, E. coli is a better indicator of fecal contamination than 
fecal coliforms. The provisions of the RTCR reflect the improved 
understanding of the value of total coliforms and E. coli as 
indicators.
3. Occurrence of Fecal Contamination and Waterborne Pathogens
    a. Presence of fecal contamination. Fecal contamination is a very 
general term that includes all of the organisms found in feces, both 
pathogenic and nonpathogenic. Fecal contamination can occur in drinking 
water both through use and inadequate treatment of contaminated source 
water as well as direct intrusion of fecal contamination into the 
drinking water distribution system. Lieberman et al. (1994) discuss the 
general association between fecal contamination and waterborne 
pathogens. Biofilms in distribution systems may harbor waterborne 
bacterial pathogens and accumulate enteric viruses and parasitic 
protozoa (Skraber et al. 2005; Helmi et al. 2008). Waterborne pathogens 
in biofilms may have entered the distribution system as fecal 
contamination from humans or animals.
    Co-occurrence of indicators and waterborne pathogens is difficult 
to measure. While the analytical methods approved by EPA to assay for 
E. coli are able to detect indicators of fecal contamination, they do 
not specifically identify most of the pathogenic E. coli strains. There 
are at least 700 recognized E. coli strains (Kaper et al. 2004) and 
about 10 percent of recognized E. coli strains are pathogenic to humans 
(Feng 1995; Hussein 2007; Kaper et al. 2004). Pathogenic E. coli 
include E. coli O157:H7, which is the primary cause of HUS in the 
United States (Rangel et al. 2005). The US Centers for Disease Control 
and Prevention (CDC) estimates that there are 73,000 cases of illness 
each year in the US due to E. coli O157:H7 (Mead et al. 1999). The CDC 
estimates that about 15 percent of all reported E. coli O157:H7 cases 
are due to water contamination (Rangel et al. 2005). Active 
surveillance by CDC shows that 6.3 percent of E. coli O157:H7 cases 
progress to HUS (Griffin and Tauxe 1991; Gould et al. 2009) and about 
12 percent of HUS cases result in death within four years (Garg et al. 
2003). About 4 to 15 percent of cases are transmitted within households 
by secondary transmission (Parry and Salmon 1998).
    Because EPA-approved standard methods for E. coli do not typically 
identify the presence of the pathogenic E. coli strains, an E. coli-
positive monitoring result is an indicator of fecal contamination but 
is not necessarily a measure of waterborne pathogen occurrence. 
Specialized assays and methods are used to identify waterborne 
pathogens, including pathogenic E. coli.
    One notable exception is the data reported by Cooley et al. (2007), 
which showed high concentrations of pathogenic E. coli strains in 
samples containing high concentrations of fecal indicator E. coli. 
These data are from streams and other poor quality surface waters 
surrounding California spinach fields associated with the 2006 E. coli 
O157:H7 foodborne outbreak. Data equivalent to these samples are not 
available from drinking water samples collected under the 1989 TCR.
    Because E. coli is an indicator of fecal contamination (Edberg et 
al. 2000), and because of the general association between fecal 
contamination and waterborne pathogens (Lieberman et al. 1994; 
Lieberman et al. 2002), E. coli is a meaningful indicator for fecal 
contamination and the potential presence of associated pathogen 
occurrence.
    b. Waterborne disease outbreaks. The CDC defines a waterborne 
disease outbreak as occurring when at least two persons experience a 
similar illness after ingesting a specific drinking water (or after 
exposure to recreational water) contaminated with pathogens (or 
chemicals) (Kramer et al. 1996), or when one person experiences amoebic 
meningoencephalitis after similar waterborne exposure. The CDC 
maintains a database on waterborne disease outbreaks in the United 
States. The database is based upon responses to a voluntary and 
confidential survey form that is completed by State and local public 
health officials.
    The National Research Council strongly suggests that the number of 
identified and reported outbreaks in the CDC database for surface and 
ground waters represents only a small percentage of the actual number 
of waterborne disease outbreaks (NRC 1997; Bennett et al. 1987; Hopkins 
et al. 1985 for Colorado data). Under-reporting occurs because most 
waterborne outbreaks in community water systems are not recognized 
until a sizable proportion of the population is ill (Perz et al. 1998; 
Craun 1996), perhaps 1 percent to 2 percent of the population (Craun 
1996). EPA drinking water regulations are designed to protect against 
endemic waterborne disease and to minimize waterborne outbreaks. In 
contrast to outbreaks, endemic disease refers to the persistent low to 
moderate level or the usual ongoing occurrence of illness in a given 
population or geographic area (Craun et al. 2006).

III. Requirements of the Revised Total Coliform Rule

    The RTCR maintains and strengthens the objectives of the 1989 TCR 
and is consistent with the recommendations in the AIP. The objectives 
are: (1) To evaluate the effectiveness of treatment, (2) to determine 
the integrity of the distribution system, and (3) to signal the 
possible presence of fecal contamination. The RTCR better addresses 
these objectives by requiring systems that may be vulnerable to fecal 
contamination (as indicated by their monitoring results) to do an 
assessment, to identify whether any sanitary defect(s) is (are) 
present, and to correct the defects. Therefore, the Agency anticipates 
greater public health protection under the RTCR compared to the 1989 
TCR because of its more preventive approach to identifying and fixing 
problems that affect or may affect public health. The following is an 
overview of the key provisions of the RTCR:
     MCLG and MCL for E. coli and coliform treatment technique 
for protection against potential fecal contamination. The RTCR 
establishes a maximum contaminant level goal (MCLG) and maximum 
contaminant level (MCL) for E. coli. Under the RTCR there is no longer 
a monthly maximum contaminant level (MCL) violation for multiple total 
coliform detections. The RTCR takes a preventive approach to protecting 
public health by establishing

[[Page 10275]]

a coliform treatment technique for protection against potential fecal 
contamination. The treatment technique uses both total coliforms and E. 
coli monitoring results to start an evaluation process that, where 
necessary, requires the PWS to conduct follow-up corrective action that 
could prevent future incidences of contamination and exposure to fecal 
contamination and/or waterborne pathogens. See section III.B of this 
preamble, Rule Construct: MCLG and MCL for E. coli and Coliform 
Treatment Technique, for further discussion on the MCLG, MCL, and 
treatment technique requirements.
     Monitoring. As with the 1989 TCR, PWSs will continue to 
monitor for total coliforms and E. coli according to a sample siting 
plan and schedule specific to the system.
    Sample siting plans under the RTCR must continue to be 
representative of the water throughout the distribution system. Under 
the RTCR, systems have the flexibility to propose repeat sample 
locations that best verify and determine the extent of potential 
contamination of the distribution system rather than having to sample 
within five connections upstream and downstream of the total coliform-
positive sample location. In lieu of proposing new repeat sample 
locations, the systems may stay with the default used under the 1989 
TCR of within-five-connections-upstream-and-downstream of the total 
coliform-positive sample location.
    As with the 1989 TCR, the RTCR allows reduced monitoring for some 
small ground water systems. The RTCR is expected to improve public 
health protection compared to the 1989 TCR by requiring small ground 
water systems that are on or wish to conduct reduced monitoring to meet 
certain eligibility criteria. Examples of the criteria include a 
sanitary survey showing that the system is free of sanitary defects, a 
clean compliance history for 12 months, and a recurring annual site 
visit by the State and/or a voluntary Level 2 assessment for systems on 
annual monitoring.
    For small ground water systems, the RTCR requires increased 
monitoring for high-risk systems such as those that do not have a clean 
compliance history under the RTCR. The RTCR specifies conditions under 
which systems will no longer be eligible for reduced monitoring and be 
required to return to routine monitoring or to monitor at an increased 
frequency.
    The RTCR requires systems on a quarterly or annual monitoring 
frequency (applicable only to ground water systems serving 1,000 or 
fewer people) to collect at least three additional routine monitoring 
samples the month following one or more total coliform-positive 
samples, unless the State waives the additional routine monitoring. 
This is a reduction in the required number of additional routine 
samples from the 1989 TCR, which requires at least five routine samples 
in the month following a total coliform-positive sample for all systems 
serving 4,100 or fewer people.
    The 1989 TCR requires all systems serving 1,000 or fewer people to 
collect at least four repeat samples while requiring PWSs serving 1,000 
people or greater to collect three repeat samples. The RTCR requires 
three repeat samples after a routine total coliform-positive sample, 
regardless of the system type and size.
    See sections III.C, Monitoring, and III.D, Repeat Samples, of this 
preamble for detailed discussions of the routine monitoring and repeat 
sampling requirements of the RTCR.
     Seasonal systems. For the first time, the RTCR establishes 
monitoring requirements specific to seasonal systems. Seasonal systems 
represent a special case in that the shutdown and start-up of these 
water systems present additional opportunities for contamination to 
enter or spread through the distribution system. Under the RTCR, 
seasonal systems must demonstrate completion of a State-approved start-
up procedure. See sections III.A.4, Seasonal systems, and III.C.1.f, 
Seasonal systems, of this preamble for further discussion of 
requirements for seasonal systems.
     Assessment and corrective action. As part of a treatment 
technique, all PWSs are required to assess their systems when 
monitoring results show that the system may be vulnerable to 
contamination. Systems must conduct either a Level 1 assessment or a 
more detailed Level 2 assessment depending on the level of concern 
raised by the results of indicator sampling. The system is responsible 
for correcting any sanitary defect(s) found through either a Level 1 or 
Level 2 assessment. See section III.E of this preamble, Coliform 
Treatment Technique, for more discussion of the treatment technique 
requirement of the RTCR.
     Violations and public notification. The RTCR establishes 
an E. coli MCL violation, a treatment technique violation, a monitoring 
violation, and a reporting violation. Public notification is required 
for each type of violation, with the type of notification dependent on 
the degree of potential public health concern. This is consistent with 
EPA's current public notification requirements under 40 CFR part 141 
subpart Q. The RTCR also modifies the public notification and Consumer 
Confidence Report language to reflect the construct of the rule. See 
sections III.F, Violations, and III.G, Providing Notification and 
Information to the Public, of this preamble for further discussions of 
violations and public notification under the RTCR.
     Transition to the RTCR. The RTCR allows all systems to 
transition to the new rule at their 1989 TCR monitoring frequency, 
including systems on reduced monitoring under the 1989 TCR. For ground 
water systems serving 1,000 or fewer people, States must conduct a 
special monitoring evaluation during each sanitary survey after the 
compliance effective date of the RTCR. Initial grandfathering of 
monitoring frequencies reduces State burden by not requiring the State 
to determine appropriate monitoring frequency at the same time the 
State is working to adopt primacy, develop policies, and train their 
own staff and the PWSs in the State.
    The provisions of the RTCR are contained in the new 40 CFR part 141 
subpart Y, superseding 40 CFR 141.21 beginning April 1, 2016.

A. RTCR Definitions

1. Assessment
    a. Provisions. EPA is defining a Level 1 assessment and a Level 2 
assessment to help in the implementation of the RTCR and to better 
differentiate between the two levels of assessments.
    A Level 1 assessment is an evaluation to identify the possible 
presence of sanitary defects, defects in distribution system coliform 
monitoring practices, and (when possible) the likely reason that the 
system triggered the assessment. It is conducted by the system operator 
or owner (or his designated representative). Minimum elements include 
review and identification of atypical events that could affect 
distributed water quality or indicate that distributed water quality 
was impaired; changes in distribution system maintenance and operation 
that could affect distributed water quality (including water storage); 
source and treatment considerations that bear on distributed water 
quality, where appropriate (e.g., whether a ground water system is 
disinfected); existing water quality monitoring data; and inadequacies 
in sample sites, sampling protocol, and sample processing. The system 
must conduct the assessment consistent with any State directives that 
tailor specific assessment elements with respect to the size and type 
of the system and the size, type, and

[[Page 10276]]

characteristics of the distribution system.
    A Level 2 assessment is an evaluation to identify the possible 
presence of sanitary defects, defects in distribution system coliform 
monitoring practices, and (when possible) the likely reason that the 
system triggered the assessment. A Level 2 assessment provides a more 
detailed examination of the system (including the system's monitoring 
and operational practices) than does a Level 1 assessment through the 
use of more comprehensive investigation and review of available 
information, additional internal and external resources, and other 
relevant practices. It is conducted by an individual approved by the 
State, which may include the system operator. Minimum elements include 
review and identification of atypical events that could affect 
distributed water quality or indicate that distributed water quality 
was impaired; changes in distribution system maintenance and operation 
that could affect distributed water quality (including water storage); 
source and treatment considerations that bear on distributed water 
quality, where appropriate (e.g., whether a ground water system is 
disinfected); existing water quality monitoring data; and inadequacies 
in sample sites, sampling protocol, and sample processing. The system 
must conduct the assessment consistent with any State directives that 
tailor specific assessment elements with respect to the size and type 
of the system and the size, type, and characteristics of the 
distribution system. The system must comply with any expedited actions 
or additional actions required by the State in the case of an E. coli 
MCL violation.
    b. Key issues raised. EPA did not propose definitions for Level 1 
and Level 2 assessments. However, based on the comments EPA received, 
there was concern that the distinction between the two levels of 
assessment is not sufficiently laid out in the rule language. This 
might pose some problems in the implementation of the RTCR. In 
response, EPA is defining a Level 1 assessment and a Level 2 
assessment. This issue and the RTCR requirements regarding assessments 
are discussed further in section III.E.2 of this preamble, Assessment.
2. Clean Compliance History
    a. Provisions. In the final RTCR, EPA is defining ``clean 
compliance history'' as a record of no maximum contaminant level (MCL) 
violations under 40 CFR 141.63; no monitoring violations under 40 CFR 
141.21 or subpart Y; and no coliform treatment technique trigger 
exceedances or coliform treatment technique violations under subpart Y. 
This is the same definition that the advisory committee recommended in 
the AIP and that EPA proposed in July 2010 (USEPA 2010a, 75 FR 40926, 
July 14, 2010). The term is specific to RTCR compliance and is used to 
determine eligibility of systems for reduced monitoring. It does not 
include violations under other existing NPDWRs. Systems must have a 
``clean compliance history'' for a minimum of 12 months to qualify for 
reduced monitoring (see sections III.C.1.b.iii, Reduced monitoring, and 
III.C.1.c.iii, Reduced monitoring, of this preamble regarding reduced 
monitoring).
    However, while the definition of ``clean compliance history'' 
includes only 1989 TCR/RTCR violations, the State may (and should) 
consider compliance history under other rules if relevant. For example, 
failure to take a triggered source water sample required under the GWR 
(USEPA 2006, 71 FR 65574, November 8, 2006) may appropriately cause the 
State to not allow less frequent monitoring because this could (1) lead 
the system to miss source water contamination and (2) indicate a 
system's lack of attention to regulatory requirements or proper 
operation.
    b. Key issues raised. EPA received comments that a record of no 
monitoring violations should not be included in the definition of 
``clean compliance history.'' Commenters are concerned that small 
systems, which experience frequent turnover or shortage of staff, may 
not be able to qualify for reduced monitoring if they miss a sample or 
two. EPA believes that a system on a reduced monitoring frequency 
(i.e., less than monthly, either quarterly or annually) must be able to 
demonstrate that it is capable of delivering safe water and maintaining 
proper attention to the water system, even on an infrequent monitoring 
schedule, by meeting certain criteria (see sections III.C.1.b.iii, 
Reduced monitoring, and III.C.1.c.iii, Reduced monitoring, of this 
preamble for discussion about the reduced monitoring criteria). Small 
systems monitoring less frequently than monthly, especially those 
monitoring only annually, already have a lower probability of detecting 
a contamination event compared to systems that monitor monthly. Because 
of the intermittent nature of contamination and the fact that these 
systems are already on a significantly reduced monitoring frequency, it 
is very important that these systems take their samples as required. 
Because these systems monitor so infrequently, EPA recommends that the 
States use the annual site visits as an opportunity to review system 
operations, reinforce the importance of collecting the required 
samples, and to identify and require correction of any sanitary 
defects. The State can make sure that the system takes its required 
sample, and therefore avoids incurring a monitoring violation because 
of a missed sample (see section III.C.1.b.iii of this preamble, Reduced 
monitoring, for discussion of annual monitoring). EPA is therefore 
retaining the definition of ``clean compliance history'' as proposed 
because EPA believes that removing the record of no monitoring 
violation from the definition would be less protective of public 
health. However, EPA is providing flexibility to the States in 
considering monitoring violations in TNCWSs when determining whether 
the system must go on increased monthly monitoring. See sections 
III.C.1.b, Ground water NCWSs serving or dewatering of the distribution system. Other 
commenters expressed concern about contamination associated with lack 
of water movement and loss of disinfectant

[[Page 10278]]

residual even in a pressurized system. Although the definition of 
seasonal systems does not directly address these issues, seasonal 
systems are required to perform start-up procedures (which may include 
disinfection, flushing, and coliform sampling) prior to serving water 
to the public. See section III.C.1.f of this preamble, Seasonal 
systems, for a discussion of the requirements for seasonal systems. EPA 
believes that it is important for a seasonal system to perform start-up 
procedures to mitigate the public health risks associated with stagnant 
water and the depressurization and/or dewatering of the distribution 
system. Hence, failure to perform start-up procedures will result in a 
treatment technique violation. See section III.F.b of this preamble, 
Coliform treatment technique violation, for additional discussion on 
this violation.
    Since it is possible and perhaps likely that some systems may keep 
the distribution system pressurized while out of season, EPA has 
included an additional provision in the RTCR whereby a State can exempt 
any seasonal system from some or all of the requirements for seasonal 
systems if the entire distribution system remains pressurized during 
the entire period that the system is not operating (see Sec. Sec.  
141.854(i)(3), 141.856(a)(4)(ii), and 141.857(a)(4)(ii) of the RTCR). 
In providing such exemption, the State should conclude that public 
health protection is maintained. However, a seasonal system monitoring 
less frequently than monthly must still monitor during the vulnerable 
period designated by the State. See section III.C.1.f of this preamble, 
Seasonal systems, for additional discussion.
    Some commenters suggested that seasonal systems be defined by the 
number of days, months, or quarters they are not in operation, e.g., 
30, 60, or 90 consecutive days, three or more consecutive months, one 
full calendar quarter, etc. While such a change could address some of 
EPA's concerns, it does not address the potential for contamination 
associated with lack of operation and loss of pressure.

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

1. MCLG and MCL
    a. Requirements. Under the final RTCR, EPA is eliminating the MCLG 
for total coliforms (including fecal coliforms) and the MCL for total 
coliforms. EPA is also establishing an MCLG of zero and an MCL for E. 
coli. The MCL for E. coli is based on the monitoring results for total 
coliforms and E. coli. A system is in compliance with the E. coli MCL 
unless any of the following conditions occur:
     A system has an E. coli-positive repeat sample following a 
total coliform-positive routine sample; or
     A routine sample is E. coli-positive and one of its 
associated repeat samples is total 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.
    Although not explicitly stated, as a logical consequence of the 
second condition, a system also violates the MCL when an E. coli-
positive routine sample is followed by an E. coli-positive repeat 
sample because E. coli bacteria are a subset of total coliforms.
    EPA is establishing an MCLG of zero for E. coli and removing the 
current MCLG of zero for total coliforms (including fecal coliforms) 
because E. coli is a more specific indicator of fecal contamination and 
potential harmful pathogens in drinking water than are total coliforms 
(including fecal coliforms). These requirements were part of the July 
2010 proposed rule (USEPA 2010a, 75 FR 40926, July 14, 2010) and are 
unchanged in the final RTCR. See section III.A.2 of the preamble to the 
proposed RTCR, MCLG and MCL for E. coli, and coliform treatment 
technique, for further discussion on the MCLG, MCL, and treatment 
technique requirements.
    b. Key issues raised. The majority of the commenters supported 
EPA's proposal to remove the MCLG and MCL for total coliforms 
(including fecal coliforms) and to establish an MCLG and MCL for E. 
coli.
    However, there were some who commented that removing the MCLG and 
MCL for total coliforms will result in backsliding in public health 
protection. These commenters stated that the elimination of the non-
acute MCL violation removes a strong incentive for water systems to 
perform proactive maintenance and operations activities to maintain 
distribution system water quality and avoid MCL violations and 
subsequent public notice to customers. EPA disagrees. EPA and the 
advisory committee decided that removing the MCLG and MCL for total 
coliforms is appropriate. SDWA section 1412(b)(3)(A)(i) directs EPA to 
use ``the best available, peer-reviewed science and supporting studies 
conducted in accordance with sound and objective science practices'' in 
conducting the risk assessment when promulgating an NPDWR. In 1989, EPA 
set an MCLG of zero for total coliforms. Since the promulgation of the 
1989 TCR, a better understanding of the nature of total coliforms, 
especially fecal coliforms, has become available. Many of the organisms 
detected by total coliform and fecal coliform methods are not of fecal 
origin and do not have any direct public health implications (Edberg et 
al. 2000). Total coliforms may, however, indicate the presence of a 
pathway by which fecal contamination can occur; thus, total coliforms 
are instead used as part of a treatment technique requirement, which is 
discussed in more detail in the next section and in section III.E of 
this preamble, Coliform Treatment Technique. Inclusion of the MCLG and 
MCL for total coliforms is not supported by the available science and 
would be contrary to SDWA section 1412(b)(3)(A)(i).
    Commenters agreed with EPA's proposal to eliminate the provisions 
on fecal coliforms. Therefore, fecal coliforms will no longer be used 
in the RTCR and all analytical methods used to detect for fecal 
coliforms are also removed from the rule. For a discussion on 
analytical methods, see section III.I of this preamble, Analytical 
Methods.
2. Coliform Treatment Technique
    a. Requirements. EPA is establishing a treatment technique that 
will require a PWS to conduct an assessment of its system and, when 
necessary, perform corrective actions in response to trigger conditions 
that indicate a possible pathway of contamination into the system. The 
treatment technique requirements are the same as those in the proposed 
RTCR. A PWS that exceeds a specified frequency of total coliform 
occurrence must conduct a Level 1 or Level 2 assessment to determine if 
any sanitary defect exists and, if found, to correct the sanitary 
defect. As discussed earlier, the MCLG and MCL for total coliforms are 
removed. The conditions that defined a non-acute MCL violation under 
the 1989 TCR are now used to trigger a system to conduct an assessment 
of the system. A discussion of the treatment technique requirements, 
i.e., the triggers, the levels of assessment, the completion of the 
assessment form, etc., can be found in section III.E of this preamble, 
Coliform Treatment Technique.
    b. Key issues raised. The majority of the commenters supported the 
change from a total coliform non-acute MCL to a treatment technique 
requirement. However, some commenters disagreed with the change. They 
stated that the treatment technique construct will not work for small 
NCWSs since they typically do not treat their water, have

[[Page 10279]]

no certified operator, and have limited or no distribution system. They 
noted that since systems with limited or no distribution system do not 
have the extensive network of piping and service connections and other 
elements that comprise a typical distribution system, the treatment 
technique construct, which the commenters considered as focusing on the 
distribution system, will not work. These commenters suggested that for 
systems with limited or no distribution system, the focus should be on 
the source, and therefore, the requirements of the GWR should be 
sufficient. They suggested that the total coliform MCL should be 
retained for these systems because the treatment technique requirements 
will be too complicated for these systems to comply with, resulting in 
more non-compliance, more burden on the State, and likely less public 
health protection.
    EPA disagrees that the treatment technique construct will not work 
for small NCWSs. The requirement to assess the system after a trigger 
consists of looking at all of the elements that might have affected the 
quality of the distributed water, including not only the distribution 
system but also the source and the treatment process. Although some 
small systems have limited or no distribution system, they can still 
have parts of their system (e.g., building plumbing, or buried piping 
at a campground) that are vulnerable to contamination, such as that 
introduced by a cross-connection or infiltration. In addition, relying 
only on the corrective action provisions of the GWR will leave out 
those systems not covered by the GWR, or in cases of positive results, 
systems where corrective action under the GWR is not immediately 
required by the State. For example, total coliform-positive repeat 
samples do not trigger any action under the GWR, even if those samples 
are also triggered source water samples. Also, a State may require 
additional source samples instead of a corrective action after the 
first fecal indicator positive sample (see 40 CFR 141.402(a)(3)). In 
addition, some small NCWSs with limited or no distribution system use 
surface water. Finally, the GWR provisions are focused on the source 
water. Since contamination is intermittent and can be from a location 
other than the source water, the assessment and corrective action 
provisions in the RTCR will help address other types of defects.
    EPA understands that there will be implementation challenges during 
the first few years of the rule implementation, especially for small 
PWSs. However, as systems with limited or no distribution system are 
simple systems, the assessments should also be relatively simple. There 
is nothing in the RTCR that prohibits the States from conducting 
assessments that integrate the requirements of the GWR and RTCR where 
appropriate (see section III.E of this preamble, Coliform Treatment 
Technique, for a discussion of the coliform treatment technique). EPA 
encourages States to make any necessary modifications to their 
regulations to make the most efficient use of limited State resources 
and to better integrate these rules for systems with little-to-no 
distribution system, provided that the revisions satisfy the primacy 
requirements for both the GWR and the RTCR. Also, EPA plans to develop 
guidance manuals specifically for small systems to help them comply 
with the RTCR. EPA is also working to update the Safe Drinking Water 
Information System (SDWIS) to include the requirements of the RTCR and 
have SDWIS ready in advance of the compliance date for the rule.
    As discussed earlier, EPA believes that the treatment technique 
requirements are more protective of public health because they require 
a system to take preventive actions to address problems. This is a 
change from just issuing a PN and conducting additional monitoring 
under the 1989 TCR to proactively doing an assessment to determine the 
cause of the possible contamination under the RTCR and performing 
corrective action where needed.

C. Monitoring

1. Requirements
    a. Requirements that apply to all PWSs. As with the 1989 TCR, the 
RTCR requires all PWSs to collect and test samples for total coliforms 
and E. coli according to a sample siting plan and schedule specific to 
the system. PWSs must collect the samples at regular intervals 
throughout the month, except systems that use only ground water and 
serve 4,900 or fewer people may collect all required samples on a 
single day if they are taken from different sites.
    Under the RTCR, all PWSs are still required to take repeat samples 
within 24 hours of learning of any routine monitoring sample that is 
total coliform-positive. PWSs must comply with the repeat monitoring 
requirements and E. coli analytical requirement, discussed in detail in 
section III.D of this preamble, Repeat Samples. All samples taken for 
RTCR compliance (routine and repeat) may occur at a customer's 
premises, dedicated sampling station, or other designated compliance 
sampling location.
    EPA notes that a system must still take the required minimum number 
of samples even if it has had an E. coli MCL violation or has exceeded 
the coliform treatment triggers before the end of the monitoring 
compliance period. For example, if a system has an E. coli MCL 
violation after taking 10 of the 40 required routine monthly samples, 
the system must continue routine total coliform monitoring, analyze any 
total coliform-positive samples for E. coli, and take one round of 
repeat samples following any total coliform-positive routine sample.
    Under the RTCR, systems' sample siting plans must include routine 
and repeat sample sites and any sampling points necessary to meet the 
Ground Water Rule (GWR) requirements. As with the 1989 TCR, the sample 
siting plan is subject to State review and revision.
    The repeat sample sites may be alternative monitoring locations 
that the PWS is proposing to use instead of the repeat sample locations 
that are within five connections upstream and downstream of the 
original sampling location that tested total coliform-positive. The PWS 
must demonstrate to the State's satisfaction that the alternative 
monitoring locations are representative of a pathway for contamination 
into the distribution system (for example, near a storage tank), and 
that the sample siting plan remains representative of the water quality 
in the distribution system. Systems may elect to specify either 
alternative fixed locations or criteria for selecting their repeat 
sampling locations on a situational basis in a standard operating 
procedure (SOP), which is part of the sample siting plan. The State may 
determine that monitoring at the entry point to the distribution system 
(especially for undisinfected ground water systems) is effective to 
differentiate between potential source water and distribution problems. 
The use of alternative monitoring locations or an SOP does not require 
prior State approval but systems are required to submit to their 
primacy agencies their proposed alternative locations. States can 
modify and revise these locations or the SOP as needed. Additional 
discussion about the alternative monitoring locations can be found in 
section III.D of this preamble, Repeat Samples.
    Monitoring locations that serve both as a repeat sampling location 
and a triggered source water monitoring location for the GWR (i.e., 
locations for dual purpose sampling) must also be included in the 
sample siting plan. These locations need to be approved by

[[Page 10280]]

the State before the PWS can use them. For more discussion on the dual 
purpose sampling, see section III.D of this preamble, Repeat Samples.
    Under the RTCR, PWSs may take more than the minimum required number 
of routine samples and must include the results in calculating whether 
the total coliform treatment technique trigger for conducting an 
assessment has been exceeded, but only if the samples are taken in 
accordance with the sample siting plan and are representative of water 
throughout the distribution system (see section III.E of this preamble, 
Coliform Treatment Technique, for a discussion on the coliform 
treatment technique requirements).
    Under the RTCR, EPA is not making substantive changes to the 
requirements of the TCR for (1) special purpose samples, and (2) 
invalidation of total coliform samples.
    New systems that begin operation on or after the compliance date of 
the RTCR must comply with the routine monitoring frequency established 
by the RTCR for their system size and type beginning in their first 
month of operation.
    The following are the monitoring requirements for different 
categories of systems.
    b. Ground water NCWSs serving  The system must have a clean compliance history (no MCL 
violations or monitoring violations under the 1989 TCR and/or RTCR, no 
Level 1 or Level 2 trigger exceedances or treatment technique 
violations under the RTCR) for a minimum of 12 months. (For a more 
detailed discussion on Level 1 and Level 2 triggers, see section III.E 
of this preamble, Coliform Treatment Technique);
     The most recent sanitary survey shows the system is free 
of sanitary defects, has a protected water source and meets approved 
construction standards; and
     An initial site visit by the State within the last 12 
months to qualify for reduced annual monitoring, and recurring annual 
site visits to stay on reduced annual monitoring; and correction of all 
identified sanitary defects. A voluntary Level 2 assessment by a party 
approved by the State may be substituted for the State annual site 
visit in any given year.
    iv. Increased monitoring. Ground water NCWS serving 1,000 or fewer 
people on quarterly or annual monitoring must begin monthly monitoring 
the month after any of the following events occurs:
     The system triggers a Level 2 assessment or two Level 1 
assessments in a rolling 12 month period;
     The system has an E. coli MCL violation;
     The system has a coliform treatment technique violation 
(for example, if the system fails to conduct a Level 1 assessment or 
correct for sanitary defects if required to do so);
     The system on quarterly monitoring has two RTCR monitoring 
violations; or
     The system has one RTCR monitoring violation and triggers 
a Level 1 assessment in a rolling 12-month period.
    EPA added the last condition by which a ground water NCWS serving 
 The system on annual monitoring has one RTCR monitoring 
violation.
    This is a change from the proposed rule requirement where the event 
would have triggered the system to go to monthly monitoring instead of 
quarterly monitoring. This change is further discussed in section 
III.C.2.b of this preamble, Ground water NCWSs serving  Within the last 12 months, the system must have a 
completed sanitary survey or a site visit by the State or a voluntary 
Level 2 assessment by a party approved by the State. The system is free 
of sanitary defects, and has a protected water source; and
     The system has a clean RTCR compliance history (no E. coli 
MCL violations, Level 1 or 2 triggers, coliform treatment technique 
violations or monitoring violations) for a minimum of 12 months.
    For TNCWSs, the State may elect not to count monitoring violations 
towards the requirement of a clean compliance history (as presented in 
the last bullet) if the missed sample is collected no later than the 
end of the next monitoring period. This applies only for routine 
samples. The TNCWS would still incur a monitoring violation and must 
follow the other requirements associated with such violation (e.g., 
public notification and reporting). See section III.C.2.b of this 
preamble, Ground water NCWSs serving  An annual site visit (recurring) by the State and 
correction of all identified sanitary defects. An annual voluntary 
Level 2 assessment may be substituted for the State annual site visit 
in any given year; and
     The system must have in place or adopt one or more 
additional enhancements to the water system barriers to contamination 
as approved by the State. These measures could include but are not 
limited to the following:

--Cross connection control, as approved by the State.
--An operator certified by an appropriate State certification program, 
which may include regular visits by a circuit rider certified by an 
appropriate State certification program.
--Continuous disinfection entering the distribution system and a 
residual in the distribution system in accordance with criteria 
specified by the State.
--Maintenance of at least a 4-log inactivation or removal of viruses 
each day of the month based on daily monitoring as specified in the GWR 
(with allowance for a 4-hour exception).
--Other equivalent enhancements to water system barriers to 
contamination as approved by the State.
    vii. Additional routine monitoring. All systems collecting samples 
on a quarterly or annual frequency must conduct additional routine 
monitoring following a single total coliform-positive sample (with or 
without a Level 1 trigger event). The additional routine monitoring 
consists of three samples in the month following the total coliform-
positive sample at routine monitoring locations identified in the 
sample siting plan. This is a change from the 1989 TCR additional 
routine monitoring requirement of taking a total of five samples the 
month following a total coliform-positive sample for systems that take 
four or fewer samples per month. Consistent with the 1989 TCR, the 
State may waive the additional routine monitoring requirement if:
     The State, or an agent approved by the State, performs a 
site visit before the end of the next month the system provides water 
to the public. Although a sanitary survey need not be performed, the 
site visit must be sufficiently detailed to allow the State to 
determine whether additional monitoring and/or any corrective action is 
needed. The State cannot approve an employee of the system to perform 
this site visit, even if the employee is an agent approved by the State 
to perform sanitary surveys or RTCR assessments.
     The State has determined why the sample was total 
coliform-positive and establishes that the system has corrected the 
problem or will correct the problem before the end of the next month 
the system serves water to the public. In this case, the State must 
document this decision to waive the following month's additional 
monitoring requirement in writing, have it approved and signed by the 
supervisor of the State official who recommends such a decision, and 
make this document available to the EPA and public. The written 
documentation must describe the specific cause of the total coliform-
positive sample and what action the system has taken and/or will take 
to correct this problem.
     The State may not waive the requirement to collect three 
additional routine samples the next month in which the system provides 
water to the public solely on the grounds that all repeat samples are 
total coliform-negative. If the State determines that the system has 
corrected the contamination problem before the system takes the set of 
repeat samples required in Sec.  141.858, and all repeat samples were 
total coliform-negative, the State may waive the requirement for 
additional routine monitoring the next month.
    All additional routine samples are included in determining 
compliance with the MCL and coliform treatment technique requirements.
    c. Ground water CWSs serving  The system must have a clean compliance history (no MCL 
violations or monitoring violations under the TCR and/or RTCR, no Level 
1 or Level 2 trigger exceedances or treatment technique violations 
under the RTCR) for a minimum of 12 months;
     The most recent sanitary survey shows the system is free 
of sanitary defects (or has an approved plan and schedule to correct 
them and is in compliance with the plan and the schedule), has a 
protected water source, and meets approved construction standards; and
     The system must meet at least one of the following 
criteria:

--An annual site visit by the State or an annual voluntary Level 2 
assessment by a party approved by the State or meeting criteria 
established by the State and correction of all identified sanitary 
defects (or an approved plan and schedule to correct them and is in 
compliance with the plan and schedule).
--A cross connection control program, as approved by the State.
--Continuous disinfection entering the distribution system and a 
residual in the distribution system in accordance with criteria 
specified by the State.
--Demonstration of maintenance of at least a 4-log inactivation or 
removal of viruses each day of the month based on daily monitoring as 
specified in the GWR (with allowance for a 4-hour exception) (USEPA 
2006c, 71 FR 65574, November 8, 2006).
--Other equivalent enhancements to water system barriers to 
contamination as approved by the State.

    iv. Requirements for returning to monthly monitoring. When a system 
on quarterly monitoring experiences any of the following events the 
system must begin monthly monitoring the month after the event occurs:
     System triggers a Level 2 assessment or two Level 1 
assessments in a rolling 12-month period.
     System has an E. coli MCL violation.
     System has a coliform treatment technique violation (e.g., 
fails to conduct a Level 1 or Level 2 assessment or to correct for a 
sanitary defect if required to do so).
     System has two routine RTCR monitoring violations in a 
rolling 12-month period.

The system must continue monthly monitoring until all the reduced 
monitoring requirements discussed previously in this section are met. A 
system that loses its certified operator must also return to monthly 
monitoring the month following the loss.
    v. Additional routine monitoring. Ground water CWSs serving  1,000 people. The monitoring 
requirements for PWSs serving more than 1,000 people remain the same as 
under the 1989 TCR (see Sec.  141.857), with the exception of the 
applicable revisions to the repeat sampling locations provided in Sec.  
141.858 and to the additional routine monitoring provisions. Systems on 
monthly monitoring are not required to take additional routine samples 
the month following a total coliform-positive sample, as recommended by 
the advisory committee (see section III.A.3.b.ii(g) of the preamble to 
the proposed RTCR, Additional routine monitoring, for an explanation of 
this change from the 1989 TCR). Consistent with the 1989 TCR, systems 
serving > 1,000 people are not eligible for reduced monitoring. In 
addition, the rule requires all seasonal systems, on and after the 
compliance date of the final RTCR, to demonstrate completion of a 
State-approved start-up procedure (see section III.C.1.f of this 
preamble, Seasonal systems, for additional discussion on seasonal 
system requirements).
    f. Seasonal systems. Since seasonal systems are a subset of NCWSs, 
they are subject to the requirements of the particular NCWS size 
category they fall under (e.g., seasonal systems using ground water and 
serving  1,000 people have the same monitoring frequency as 
other PWSs serving > 1,000 people (see Sec.  141.857 of the RTCR) and 
it cannot be reduced. However, seasonal systems serving  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.C.1.b.v of this preamble, Requirements for returning to 
quarterly monitoring, and provided in Sec.  141.854(g) of the RTCR.
     To be eligible for reduced annual monitoring, the system 
must also meet all the reduced monitoring criteria discussed in section 
III.C.1.b.vi of this preamble, Requirements for returning to reduced 
annual monitoring, and provided in Sec.  141.854(h) of the RTCR.
    The State may exempt any seasonal system from some or all of the 
requirements for seasonal systems (e.g., performing start-up 
procedures) if the entire distribution system remains pressurized 
during the entire period that the system is not operating. However, 
systems that monitor less frequently than monthly must still monitor 
during the time period designated in their approved sample siting plan.
    g. Consecutive systems. EPA did not identify any issues regarding 
consecutive systems in the RTCR. Consecutive systems must monitor for 
total coliforms at a frequency based on the population served by the 
consecutive system and the source water type of the wholesale system. 
In instances where it is justified to treat two or more distribution 
systems as a single system for monitoring purposes, 40 CFR 141.29 
allows the State to modify the monitoring requirements for the combined 
distribution system. Any modifications to the monitoring requirements 
must be approved by EPA. The State may not, however, modify the 
compliance requirements. The RTCR is not modifying the provisions of 40 
CFR 141.29. When conducting assessment and corrective action under the 
RTCR, wholesalers and consecutive systems should cooperate as directed 
by the State and conduct assessment and corrective action based on the 
location of the positive sample results, the potential pathways of 
distribution system contamination, and the sanitary defects identified.
2. Key Issues Raised
    a. Sample siting plans. The majority of the comments EPA received 
supported the proposal that sample siting plans be subject to State 
review and revision instead of requiring State approval. The advisory 
committee recommended that States review and revise sample siting plans 
consistent with current practice and that the State develops and 
implements a process to ensure the adequacy of sample siting plans. EPA 
also received comments that requiring State approval of sample siting 
plans will be an additional burden to the States. Considering these 
comments and the recommendation of the advisory committee, EPA, 
therefore, is not changing the requirement regarding State review and 
revision of the sample siting plan in most instances. There are, 
however, instances where it is necessary for the State to review and 
approve elements of the sample siting plan, and other instances where 
the need for State approval is left to State discretion. For example, 
seasonal systems on less than monthly monitoring must have an approved 
sample siting plan that designates the time period for collecting the 
sample(s) as discussed previously in section III.C.1.f of this 
preamble, Seasonal systems. On the other hand, for systems that want to 
establish repeat sampling locations other than the within-five-
connections-upstream-and-downstream of the total coliform-positive 
sample, the system must submit the siting plan for review and the State 
may modify the sampling locations as needed, but State approval is not 
required by the RTCR, as discussed in section III.D of this preamble, 
Repeat Samples.
    EPA received comment that supported the use of dedicated sampling 
locations. Although not specifically addressed this practice is already 
in use by some States and systems under the 1989 TCR. As discussed in 
the proposed RTCR, EPA is specifically allowing the use of dedicated 
sampling stations for the following reasons:
     To reduce potential contamination of the sampling taps. 
Utilities will have more control to prevent contamination of the 
sampling tap by preventing its use by unauthorized persons and allowing 
no routine use of the tap except for sampling.
     To facilitate access to sampling taps. Currently systems 
may be constrained by where they sample, e.g., only at public buildings 
or in certain individual customer's house.
     To improve sampling representation of the distribution 
system. Allowing dedicated sampling taps in areas where systems have 
not been able to gain access will facilitate better sampling 
representation of the distribution system.
    b. Ground water NCWSs serving or pay for the 
annual monitoring, reduces the likelihood that systems on annual 
monitoring will miss samples and be triggered to increase to quarterly 
monitoring, so that PWS and State resource needs are not likely to 
significantly increase because of this requirement. EPA is not changing 
the consequence of exceeding the other triggers for increased 
monitoring; systems that experienced any of the other events in section 
III.C.1.b.iv of this preamble, Increased monitoring, will need to 
monitor monthly instead of quarterly. Systems can go back to annual 
monitoring by meeting the criteria for reduced monitoring.
    EPA requested comment on whether daily chlorine residual 
measurements should be one of the criteria for reduced monitoring. EPA 
received comments that said that it should not be a criterion. Some 
commenters expressed concern that one missed measurement might be a 
basis for being bumped to increased monitoring. One commenter suggested 
giving the State the discretion to either allow or not allow it as a 
criterion. Section 141.854(h)(2)(iii) of the RTCR specifies that one of 
the

[[Page 10285]]

enhancements to water system barriers to contamination is continuous 
disinfection entering the distribution system and a residual in the 
distribution system in accordance with criteria specified by the State. 
States are given the discretion to decide how they want to implement 
this criterion based on site-specific considerations. States may want 
to require daily measurement of chlorine residual to demonstrate 
continuous disinfection.
    One commenter expressed concern that a reduction in the number of 
additional routine samples (i.e., from five to three) reduces the 
likelihood of detecting both total coliforms and E. coli. The advisory 
committee recommended that it is appropriate to drop from five to three 
samples the following month to reduce monitoring costs while still 
maintaining a substantial likelihood of identifying a problem if a 
problem persists. EPA and the advisory committee recognized that a 
reduction in the number of samples taken could also mean a reduction in 
the number of positive samples found. However, EPA and the advisory 
committee concluded that the new assessment and corrective action 
provisions of the RTCR lead to a rule that is more protective of public 
health and to improvement in water quality despite the reductions in 
the number of samples taken. The Final RTCR EA occurrence modeling 
results support this conclusion, as they predict that more E. coli MCL 
violations will be prevented and total coliform and E. coli-positive 
hit rates will decrease when assessment and corrective action occur. 
See chapter 6 of the Final RTCR EA (USEPA 2012a) for more details.
    c. Seasonal systems. EPA received comments that disagreed with the 
routine monthly monitoring frequency for seasonal systems. The 
commenters suggested that requiring a start-up procedure is the 
essential element and having seasonal systems monitor quarterly like 
all other NCWSs should be adequate. Other commenters agreed with 
monthly monitoring.
    As discussed in section III.A.4 of this preamble, Seasonal systems, 
seasonal systems are more susceptible to contamination due to changes 
in the conditions of the source water during the period the system is 
in operation. Such changes include variable contaminant loading due to 
increased septic tank or septic field use, the seasonal nature of the 
demand, and the stress the system may experience. Because of the risk 
factors, the advisory committee decided that more frequent monitoring 
is appropriate for these systems, with the possibility of going on 
reduced monitoring if they meet certain criteria. EPA concurs with the 
advisory committee assessment and the final rule maintains the proposed 
routine monthly monitoring frequency, when they are in operation, for 
seasonal systems.
    One commenter said that a regular sampling schedule is more easily 
achieved and more practical than identifying vulnerable time periods as 
these periods can vary from year to year. EPA believes that a system 
that will monitor less frequently than monthly should sample based on 
site-specific considerations (e.g., during periods of high demand or 
highest vulnerability of contamination). This increases the probability 
of detecting a possible contamination; hence, measures can be taken to 
address the possible contamination before it becomes a public health 
threat.
    One commenter suggested that start-up procedures must include 
flushing, disinfection, re-flushing to eliminate disinfectant residual, 
and taking a sample prior to serving water to the public. EPA is not 
requiring specific practices regarding the start-up procedure. States 
are given the flexibility to determine what start-up procedures are 
appropriate for a particular system based on its site-specific 
considerations and must describe their process for determining start-up 
procedures in their primacy application. EPA recommends that States 
require seasonal systems to take a sample as part of the required 
start-up procedures. Systems must allow sufficient time for completing 
start-up procedures (including receiving sample results) and notifying 
the State as required prior to serving water to the public.

D. Repeat Samples

1. Requirements
    Under the RTCR, all PWSs must take at least three repeat samples 
for each routine sample that tested positive for total coliforms. This 
is a change from the 1989 TCR requirements where systems serving 1,000 
or fewer people must collect at least four repeat samples while the 
rest of the systems must collect three repeat samples.
    As discussed in the preamble to the proposed RTCR, EPA believes 
that sampling again immediately after determining that a sample is 
positive (i.e., conducting repeat sampling) increases the likelihood of 
identifying the source and/or nature of the possible contamination. 
Analyses conducted by EPA indicated that once a total coliform-positive 
is found, there is a much greater likelihood of finding another total 
coliform-positive within a short period of time of the initial finding 
(see page 40939 of the Federal Register (FR) notice for the proposed 
RTCR (USEPA 2010a, 75 FR 40926, July 14, 2010) for more discussion on 
the analyses done by EPA regarding repeat samples). Repeat sampling 
(when it is total coliform-positive) can indicate a current pathway for 
potential external contamination into the distribution system. EPA 
recommends that States work with PWSs and laboratories to facilitate 
timely notification through the most expeditious method (e.g., phone, 
fax, or email) to ensure that repeat samples are taken in a timely 
manner.
    The repeat monitoring requirements of the RTCR are essentially the 
same as the requirements of the 1989 TCR, except for some new 
provisions promulgated by the RTCR to provide flexibility to States and 
PWSs. The following requirements are not changing under the RTCR:
     PWSs must collect the repeat samples within 24-hours of 
being notified that their routine sample is total coliform-positive.
     The State can extend the 24-hour limit on a case-by-case 
basis. EPA is providing flexibility to this provision as discussed 
later in this section.
     The State cannot waive the requirement for a system to 
collect repeat samples.
     In addition to taking repeat samples, PWSs must test each 
routine total coliform-positive sample for E. coli. They must also test 
any repeat total coliform-positive sample for E. coli. If E. coli is 
present, the system must notify the State the same day it learns of the 
positive result, or by the end of the next business day if the State 
office is closed and the State does not have either an after-hours 
phone line or an alternative notification procedure.
     The State has the discretion to allow the system to forgo 
E. coli testing in cases where the system assumes that the total 
coliform-positive sample is E. coli-positive. If the State allows a 
system to forgo E. coli testing, the system must still notify the State 
and comply with the E. coli MCL requirements specified in Sec.  
141.858.
     The system must collect at least one repeat sample from 
the sampling tap where the original total coliform-positive sample was 
taken. Unless different locations are specified in its sample siting 
plan (this is a new provision of the RTCR and is discussed later in 
this section), the system must also collect at least one repeat sample 
at a tap within five service connections upstream, and at least one 
repeat sample at a tap within five service connections

[[Page 10286]]

downstream of the original sampling site. The State may waive the 
requirement to collect at least one repeat sample upstream or 
downstream of the original sampling site if the total coliform-positive 
sample is at the end of the distribution system, or one service 
connection away from the end of the distribution system. EPA notes that 
it is the location of the repeat sample that is waived, not the 
required number of repeat samples. A PWS still needs to take the 
required repeat sample(s) elsewhere in the distribution system if it is 
unable to do so upstream or downstream of the original sampling site.
     Systems must collect all repeat samples on the same day. 
The State may allow systems with a single service connection to collect 
the required set of repeat samples over a three-day period or to 
collect a larger volume repeat sample(s) in one or more sample 
containers of any size, as long as the total volume collected is at 
least 300 milliliters (ml).
     Systems must collect an additional set of repeat samples 
for each total coliform-positive repeat sample. As with the original 
set of repeat samples, the system must collect the additional repeat 
samples within 24 hours of being notified of the positive result, 
unless the State extends the time limit. The system must repeat this 
process until either total coliforms are not detected in one complete 
set of repeat samples or, as the RTCR is adding, the system determines 
that the coliform treatment technique trigger has been exceeded and 
notifies the State. After a trigger (see section III.E, of this 
preamble, Coliform Treatment Technique) is reached, the system is 
required to conduct only one round of repeat monitoring after each 
total coliform-positive or E. coli-positive routine sample. If a 
trigger is reached as a result of a repeat sample being total coliform- 
or E. coli-positive, no further repeat monitoring related to that 
sample is necessary.
     A subsequent routine sample, which is within five service 
connections of the initial routine sample and is collected after an 
initial routine sample but before the system learns the initial routine 
sample is total coliform-positive, may count as a repeat sample 
instead.
     A ground water system with a single well serving 1,000 or 
fewer people may still use a repeat sample collected from a ground 
water source to meet both the repeat monitoring requirements of the 
RTCR and the triggered source monitoring requirements of the GWR (i.e., 
a dual purpose sample). Modifications to this provision under the RTCR 
are discussed later in this section.
    As mentioned previously, the RTCR adds some new provisions to the 
repeat monitoring requirements to provide flexibility to the States and 
PWSs. One of these changes is the additional flexibility provided to 
States regarding the waiver or the extension of the 24-hour limit for a 
PWS to collect repeat samples. States are given the option to describe 
in their primacy application the criteria they will use to waive or 
extend the 24-hour limit instead of making the decisions on a case-by-
case basis. This is discussed further in section V of this preamble, 
State Implementation.
    Another change is the use of alternative monitoring locations. As 
discussed in section III.C of this preamble, Monitoring, the PWS may 
propose alternative repeat monitoring locations that are expected to 
better characterize or identify pathways of contamination into the 
distribution system. Systems may elect to specify either alternative 
fixed locations or criteria for selecting their repeat sampling 
locations on a situational basis in a standard operating procedure 
(SOP), which is part of the sample siting plan. By allowing systems to 
specify criteria for selecting their repeat sampling locations in their 
SOP instead of setting fixed repeat sampling locations, systems can 
provide a more flexible and more protective response. The system can 
focus the repeat samples at locations that will best verify and 
determine the extent of potential contamination of the distribution 
system based on specific situations. For discussion on additional 
requirements for alternative monitoring locations, see section III.C of 
this preamble, Monitoring.
    There are also some modifications to the dual purpose sampling 
allowed under the GWR and 1989 TCR. Ground water systems required to 
conduct triggered source monitoring under the GWR must take ground 
water source samples in addition to the repeat samples required by the 
RTCR. 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 RTCR and the source water 
monitoring requirements of the GWR (i.e., a dual purpose sample), but 
only if the State approves the use of a single sample to meet both rule 
requirements and the use of E. coli as a fecal indicator for source 
water monitoring. If the sample is E. coli-positive, the system 
violates the E. coli MCL under the RTCR and must also comply with the 
GWR requirements following a fecal indicator-positive sample. These 
provisions are consistent with the GWR.
    If a system with a limited number of monitoring locations (such as 
a system with only one service connection or a campground with only one 
tap) takes more than one repeat sample at the triggered source water 
monitoring location, the system may reduce the number of additional 
source water samples by the number of repeat samples taken at that 
location that were not E. coli-positive. For example, if a system takes 
two dual purpose samples and one is E. coli-positive and the other is 
E. coli-negative, the system has an E. coli MCL violation under the 
RTCR and is required to take four additional source water samples, 
rather than five, under the GWR (see 40 CFR 141.402(a)(3)). If the 
system takes more than one of these repeat samples at the triggered 
source water monitoring location and has more than one repeat sample 
that is E. coli-positive at the triggered source water monitoring 
location, then the system would have both an E. coli MCL violation 
under the RTCR and a second fecal indicator-positive source sample 
under the GWR. The system would then need to also comply with the GWR 
treatment technique requirements under 40 CFR 141.403.
    Results of all routine and repeat samples not invalidated by the 
State must be used to determine whether the coliform treatment 
technique trigger has been exceeded (see section III.E of this 
preamble, Coliform Treatment Technique, for a discussion of the 
coliform treatment technique triggers).
2. Key Issues Raised
    A majority of the commenters supported the change from four to 
three repeat samples for systems serving 1,000 or fewer people. 
However, one commenter stated that decreasing the number of repeat 
samples would also lessen the likelihood of detecting total coliforms 
and E. coli. EPA explained the analysis that EPA has done to support 
the reduction in the number of repeat samples in the preamble to the 
proposed RTCR. In that analysis, using the Six-Year Review 2 data 
(USEPA 2010c), EPA showed that if the number of required repeats were 
reduced from four to three, there would still be almost as many 
(approximately 94 percent) situations leading to an assessment being 
triggered for the system. See section III.A.4 of the preamble to the 
proposed RTCR, Repeat Samples, for a detailed discussion of EPA's 
analysis on the reduction of the number of repeat

[[Page 10287]]

samples. Although dropping the required number of repeat samples from 
four to three means that some fraction of triggered assessments may be 
missed, the other provisions of the RTCR compensate for that change 
and, taken as a whole, the provisions of the RTCR provide for greater 
protection of public health. One such provision includes enhanced 
consequences for monitoring violations. For example, systems that do 
not take all of their repeat samples under the RTCR are triggered to 
conduct a Level 1 assessment. This permits an increase in public health 
protection over the 1989 TCR because PWSs are required to assess their 
systems when lack of required monitoring creates a situation where the 
PWS does not properly know whether it is vulnerable to contamination. 
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 (see section III.E of this preamble, 
Coliform Treatment Technique, for additional discussion on the coliform 
treatment technique triggers).
    EPA also received comments generally supporting the use of 
alternative sites for repeat monitoring since they provide more 
flexibility in determining the locations of the repeat samples, 
allowing for better protection of public health on a site-specific 
basis, subject to State review. One commenter disagreed, saying that 
repeat samples should be near the original positive sample site so that 
they can provide the necessary information to confirm the original 
positive sample. A few commenters are against having within-five-
connections-upstream-and-downstream locations from the original 
positive sample as the default locations for repeat monitoring. They 
suggested that these default locations should be eliminated altogether 
and that all PWSs be allowed to take the other two repeat samples at 
alternative locations.
    EPA believes that not all systems will use the option of taking 
repeat samples at alternative locations. Some PWSs, especially small 
NCWSs, may not avail themselves of this option for reasons of 
simplicity and lack of resources and expertise. They may elect to stick 
with the set repeat monitoring locations of five connections upstream 
and downstream of the original total coliform-positive sample, as it 
will be less burdensome on them than locating alternative sites and 
demonstrating that the alternative sites are more effective. Hence, EPA 
is maintaining within-five-connections-upstream-and-downstream 
locations as the default repeat sampling locations.
    While the prescribed locations may work for some systems, other 
systems may find them too limiting. Taking repeat samples at the 
prescribed locations of within five-connections-upstream-and-downstream 
can be difficult for some systems to implement within the required 24 
hours for a repeat sample because of issues such as access to the site. 
Therefore, EPA is allowing PWSs to propose alternative repeat 
monitoring locations, either as fixed locations or as criteria in an 
SOP, to facilitate the identification of the source and extent of any 
problem. EPA believes that both the within-five-connections-upstream-
and-downstream repeat sampling locations and the locations as 
identified by an SOP can be used by the operator to better understand 
the extent and duration of potential pathways of contamination into the 
distribution system with the appropriate amount of State supervision.
    EPA requested comment on whether systems should be required to 
obtain prior State approval for using repeat monitoring sites other 
than the within-five-connections-upstream-and-downstream locations of 
the original routine total coliform-positive site. Most of the 
commenters were against requiring prior State approval for the use of 
alternative repeat monitoring locations. They suggested that it is more 
appropriate to include these sites (or the criteria to choose sites) in 
the SOP or in the sample siting plan, which is then subject to State 
review and revision. Some commenters also stated that requiring pre-
approval for each individual instance of using alternative sites is not 
practical.
    EPA agrees that obtaining prior State approval to use alternative 
repeat monitoring locations is not necessary since there is no 
reduction in monitoring and EPA expects the SOP to be used only by 
large systems with the technical resources to justify alternative 
monitoring sites. Although State approval is not required, EPA requires 
PWSs that are intending to use this option to submit their proposed 
alternative sampling sites (as part of an SOP or the sample siting 
plan) to the State. The PWS must be able to demonstrate to the State 
that the alternative monitoring sites are appropriate to help 
characterize the extent of the possible contamination. The State is 
given the discretion to review and revise the alternative monitoring 
locations consistent with their practice regarding sample siting plans. 
EPA does not require that the State formally acknowledge and approve 
the alternative monitoring locations. The alternative monitoring 
locations are considered appropriate unless the State disapproves or 
modifies them, which results in the requirement being self-
implementing.
    EPA received general support for allowing samples taken at the 
ground water source to serve both as a triggered source sample under 
the GWR and as one of the repeat samples under the RTCR (i.e., as dual 
purpose samples). Some States said that this practice is already being 
done in their States and therefore should continue under the RTCR. Most 
commenters supported the provision with the understanding that the 
practice would be subject to State approval. One commenter, however, 
disagreed with the provision and thought the PWS would not be 
collecting a sufficient number of repeat samples to represent the water 
quality in the distribution system if one of the repeat samples is 
taken at the source water. Another commenter suggested making the 
option available for ground water systems of all sizes, as it will help 
reduce labor and analytical costs, and will provide a clearer picture 
as to the location and cause of the total coliform-positive sample.
    The preamble to the proposed RTCR discussed the drawbacks to 
allowing dual purpose samples i.e., a reduction in the number of 
repeats in the distribution system. By requiring State approval of the 
use of dual purpose sampling, the RTCR ensures that this flexibility 
will only be allowed where the State has determined it is appropriate. 
EPA believes that PWSs with limited or no distribution systems are the 
best candidates for approval since there is little to no chance of 
contamination from the distribution system except from cross 
connection. On the other hand, EPA believes that dual purpose samples 
may not be appropriate for systems with extensive distribution systems 
because the reduction in monitoring (i.e., one less repeat sample in a 
distribution system that extends far from the source water sample site) 
may not provide public health protection equivalent to taking separate 
samples.
    EPA requested comment on whether the use of dual purpose samples 
should be allowed by simply including it in the sample siting plan, 
without prior State approval. As stated earlier, most of the comments 
supported allowing dual purpose sampling with the understanding that it 
will be approved by the State. Some commenters, on the other hand, said 
that it should be allowed without prior State approval. One commenter 
said that the State may not be able to review and approve the sample 
siting plan until the next

[[Page 10288]]

sanitary survey, which maybe as long as five years after the RTCR 
implementation. One commenter said that States should only be required 
to say that dual purpose sampling is not allowed for specific systems. 
Another commenter suggested allowing States to explain their process 
for approval in their primacy application, rather than each situation 
being handled on a case-by-case basis, thereby reducing administrative 
burden.
    As discussed earlier, EPA believes that requiring State approval 
for allowing dual purpose sampling limits the practice only to systems 
that can avail themselves of it without compromising public health 
protection. State approval is required because this constitutes a 
reduction in monitoring (no separate triggered source water samples), 
relative to requiring separate samples for compliance with the two 
rules. EPA believes this reduction in monitoring is appropriate only if 
the State determines that the dual purpose sample provides public 
health protection equivalent to that provided by separate repeat and 
source water samples.
    As part of the special primacy requirements for the RTCR in Sec.  
142.16(q), States adopting the reduced monitoring provisions of the 
RTCR, including dual purpose sampling, must describe how they will do 
so in their primacy application package. States must include their 
approval process for dual purpose sampling in their application. This 
gives States the flexibility to determine how and when they want to 
grant approval, i.e., whether on a case-by-case basis (whenever a total 
coliform-positive occurs) or on a pre-approved basis (i.e., the system 
has prior State approval to take a dual purpose sample whenever it is 
triggered to do source water monitoring).

E. Coliform Treatment Technique

1. Coliform Treatment Technique Triggers
    a. Requirements. The non-acute MCL violation for total coliforms 
under the 1989 TCR is replaced under the RTCR by a coliform treatment 
technique involving monitoring for total coliforms and assessment and 
corrective action when triggered. EPA is establishing an assessment 
process in the RTCR to strengthen public health protection. Under the 
1989 TCR, a system is not required to perform an assessment following a 
monthly/non-acute MCL violation or an acute MCL violation. Under the 
RTCR treatment technique framework, the presence of total coliforms is 
used as an indicator of a potential pathway of contamination into the 
distribution system. As discussed in section III.B of this preamble, 
Rule Construct: MCLG and MCL for E. coli and Coliform Treatment 
Technique, the RTCR eliminates the associated MCLG and MCL for total 
coliforms. The RTCR specifies two levels of treatment technique 
triggers, Level 1 and Level 2, and their corresponding levels of 
response. The degree and depth to which a PWS must examine its system 
and monitoring and operational practices, i.e., the difference between 
a Level 1 or Level 2 assessment, depends on the degree of potential 
pathway for contamination. A Level 2 assessment requires a more in-
depth and comprehensive review of the PWS compared to a Level 1. A 
discussion of the levels of assessments is found later in section 
III.E.2 of this preamble, Assessment.
    The system has exceeded the trigger immediately once any of the 
following conditions have been met.
    Level 1 treatment technique triggers
     For systems taking 40 or more samples per month, the PWS 
exceeds 5.0 percent total coliform-positive samples for the month; or
     For systems taking fewer than 40 samples per month, the 
PWS has two or more total coliform-positive samples in the same month; 
or
     The PWS fails to take every required repeat sample after 
any single routine total coliform-positive sample.
    The first two treatment technique triggers were the conditions that 
define a non-acute MCL violation under the 1989 TCR. The third trigger 
provides incentive for systems to take their repeat samples to ensure 
that they are assessing the extent of the total coliform contamination; 
if they do not do so by repeat sampling, they must conduct an 
assessment instead to ensure there are no pathways to contamination 
(sanitary defects). Repeat monitoring is critical in identifying the 
extent, source, and characteristics of fecal contamination in a timely 
manner. EPA's analysis, as discussed in the preamble to the proposed 
RTCR (see section III.A.4 of the preamble to the proposed RTCR, Repeat 
samples), shows that the average percentage of repeat samples that are 
positive is much higher than that of routine samples, demonstrating 
that when operators are required to take a second look at their systems 
following the positive routine sample, they find, on average, a higher 
rate of coliform presence than during routine sampling. In other words, 
the high repeat total coliform positive rate indicates the persistence 
of total coliforms at such locations in the distribution system. Since 
under the RTCR there is no additional routine monitoring for systems 
that monitor at least monthly and the number of additional routine 
monitoring and repeat monitoring samples for the smallest systems that 
are not on monthly monitoring is decreased, the need to conduct repeat 
monitoring is more crucial than ever in providing immediate and useful 
information needed to protect public health.
    Level 2 treatment technique triggers:
     The PWS has an E. coli MCL violation (see section III.F of 
this preamble, Violations, for a description of what constitutes an E. 
coli MCL violation); or
     The PWS has a second Level 1 treatment technique trigger 
within a rolling 12-month period, unless the initial Level 1 treatment 
technique trigger was based on exceeding the allowable number of total 
coliform-positive samples, the State has determined a likely reason for 
the total coliform-positive samples that caused the initial Level 1 
treatment technique trigger, and the State establishes that the system 
has fully corrected the problem; or
     For PWSs with approved reduced annual monitoring, the 
system has a Level 1 treatment technique trigger in two consecutive 
years.
    b. Key issues raised. EPA received comments that disagreed with the 
inclusion of the third Level 1 treatment technique trigger, i.e., 
failing to take every required repeat sample after any single routine 
total coliform-positive sample triggers a Level 1 assessment. Some of 
the commenters suggested that this does not pose a public health 
concern and should remain a monitoring violation because if a system 
does not conduct the required repeat monitoring, then it is doubtful 
that it will conduct the assessment. One commenter was concerned that a 
system might opt to conduct the assessment instead of taking the repeat 
samples and just indicate in the assessment form that no sanitary 
defect was found or the cause of the total coliform-positive sample 
could not be identified. The system then avoids the possibility of the 
repeat samples being total coliform- or E. coli-positive. They 
commented that since the Level 1 assessment is done by the system, 
doing the assessment will also be cheaper than taking the repeat 
samples.
    EPA disagrees that the PWS will avoid taking repeat samples because 
of economic reasons. EPA's analysis indicates that a Level 1 assessment 
costs about four times as much as taking three repeat samples (see 
Exhibits 3-12 and

[[Page 10289]]

4-7 of the Technology and Cost Document for the Final Revised Total 
Coliform Rule (USEPA 2012b)). States also must review the assessment 
form submitted by the PWS. If the assessment and/or corrective action 
is/are not acceptable to the State, the State can require the PWS to 
redo the assessment and submit a revised assessment form. EPA also 
expects that in situations where the cause of the total coliform- or E. 
coli-positive result cannot be identified, the PWS will arrive at this 
conclusion only after due diligence on its part (i.e., the system 
adheres to proper procedures and standards set by the State in 
conducting the assessment). The State may require the PWS to provide 
supporting documentation and analyses to back-up its finding. Because 
of the cost and the effort involved in conducting a Level 1 assessment, 
EPA expects that systems will want to ensure that assessments are 
conducted only when potential problems may exist rather than for 
failure to take repeat samples.
    One commenter suggested that EPA clarify that collecting samples 
outside the 24-hour required time is not a Level 1 trigger as there are 
instances when the repeat samples cannot be collected within 24 hours 
of the routine total coliform-positive sample. EPA notes that there is 
a provision in the RTCR, Sec.  141.858(a)(1), that allows the State to 
extend the 24-hour limit on a case-by-case basis if the system has a 
logistical problem in collecting the repeat samples within 24 hours 
that is beyond its control. In such cases when the State allows the 
system to collect the repeat samples beyond the 24 hours, the system 
does not trigger a Level 1 assessment.
    One commenter suggested that EPA include an additional provision 
that an assessment need not be triggered if the total coliform-positive 
occurred when there are representative levels of disinfectant residual 
in the distribution system, stating that historical total coliform-
positive results occurred with normal levels of chlorine residuals in 
the distribution system and did not cause any waterborne disease. EPA 
disagrees that there is no public health risk in this situation. The 
fact that total coliforms can be detected even in the presence of a 
disinfectant residual is an indication that there might be a bigger, 
hidden problem that needs further investigation. An assessment is 
warranted to determine if there exists a potential pathway of 
contamination into the distribution system and corrective action is 
warranted if a sanitary defect is identified.
    EPA received comments to eliminate the Level 2 treatment technique 
trigger where a second Level 1 assessment is triggered within a rolling 
12-month period, or for systems on annual monitoring, where two Level 1 
assessments in two consecutive years trigger a Level 2 assessment. Some 
of the commenters thought that many small systems will be triggered to 
conduct a Level 2 assessment multiple times. EPA believes that although 
the conditions (i.e., a second Level 1 trigger) that lead to the Level 
2 trigger do not necessarily pose an immediate acute public health 
threat, it may still pose a potential serious health impact because of 
the persistence of the contamination and the failure of the system to 
address it. EPA believes that a Level 2 assessment is warranted in this 
case because a more in-depth examination of the system is needed to 
determine the cause of the persistent occurrences of total coliforms. 
EPA also notes that, ideally, a well-performed Level 1 assessment and 
appropriate corrective action will prevent most systems from developing 
conditions that lead to a Level 2 assessment.
2. Assessment
    a. Requirements. There are two levels of assessment based on the 
associated treatment technique trigger: Level 1 assessment for a Level 
1 treatment technique trigger and Level 2 assessment for a Level 2 
treatment technique trigger. At a minimum, both Level 1 and 2 
assessments must include review and identification of the following 
elements:
     Atypical events that may affect distributed water quality 
or indicate that distributed water quality was impaired;
     Changes in distribution system maintenance and operation 
that may affect distributed water quality, including water storage;
     Source and treatment considerations that bear on 
distributed water quality, where appropriate;
     Existing water quality monitoring data; and
     Inadequacies in sample sites, sampling protocol, and 
sample processing.
    The system must conduct the assessment consistent with any State 
directives that tailor specific assessment elements with respect to the 
size and type of the system and the size, type, and characteristics of 
the distribution system. The PWS must complete the assessment as soon 
as practical after the PWS learns it has exceeded a treatment technique 
trigger. Failure to conduct a triggered assessment is a treatment 
technique violation. See section III.F.1.b of this preamble, Coliform 
treatment technique violation.
Level 1 Assessment
    A Level 1 assessment must be conducted when a PWS exceeds one or 
more of the Level 1 treatment technique triggers specified previously. 
Under the rule, this self-assessment consists of a basic examination of 
the source water, treatment, distribution system and relevant 
operational practices. The PWS should look at conditions that could 
have occurred prior to and caused the total coliform-positive sample. 
Example conditions include treatment process interruptions, loss of 
pressure, maintenance and operation activities, recent operational 
changes, etc. In addition, the PWS should check the conditions of the 
following elements: sample sites, distribution system, storage tanks, 
source water, etc.
Level 2 Assessment
    A Level 2 assessment must be conducted when a PWS exceeds one or 
more of the Level 2 treatment technique triggers specified previously. 
It is a more comprehensive examination of the system and its monitoring 
and operational practices than the Level 1 assessment. The level of 
effort and resources committed to undertaking a Level 2 assessment is 
commensurate with the more comprehensive investigation and review of 
available information, and engages additional parties and expertise 
relative to the Level 1 assessment. Level 2 assessments must be 
conducted by a party approved by the State: the State itself, a third 
party, or the PWS where the system has staff or management with the 
required certification or qualifications specified by the State. If the 
PWS or a third party conducts the Level 2 assessment, the PWS or third 
party must follow the State requirements for conducting the Level 2 
assessment. The PWS must also comply with any expedited actions or 
additional actions required by the State in the case of an E. coli MCL 
violation.
Assessment Forms
    The PWS must submit the completed assessment form for either a 
Level 1 or Level 2 assessment to the State for review within 30 days 
after the PWS learns that it has exceeded the trigger. Failure to 
submit the completed assessment form after the PWS properly conducts 
the assessment is a reporting violation (see section III.F.1.d of this 
preamble, Reporting violation). If the State determines that the 
assessment is insufficient, the State will consult with the PWS. If the 
State requires revisions after consultation, the PWS must submit

[[Page 10290]]

a revised assessment to the State on an agreed-upon schedule not to 
exceed 30 days from the date of the initial consultation.
    The completed assessment form must include assessments conducted, 
all sanitary defects found (or a statement that no sanitary defects 
were identified), corrective actions completed, and a proposed 
timetable for any corrective actions not already completed. Upon 
completion and submission of the assessment form by the PWS to the 
State, the State must determine if the system has identified the likely 
cause(s) for the Level 1 or Level 2 treatment technique trigger and, if 
so, establish that the system has corrected the problem(s). Whether or 
not the system has identified any sanitary defects or a likely cause 
for the trigger, the State may determine whether or not the assessment 
is sufficient, and if it is not, the State must discuss its concerns 
with the system. The State may require revisions to the assessment 
after the consultation.
    b. Key issues raised. The RTCR requires assessments to identify 
whether potential pathways of contamination into the distribution 
system exist after monitoring results indicate the system has exceeded 
a trigger. However, some commenters disagreed that requiring 
assessments will result in better public health protection. For one, 
they stated that assessments are already occurring under the 1989 TCR; 
hence, there is no need to formally require them. Second, assessments 
conducted by small systems will not likely be adequate as these systems 
usually do not have the resources and the capability to conduct a 
proper assessment. The States will then have to perform the assessments 
themselves (even the Level 1 assessments), thus adding to State burden. 
Third, assessments will reduce follow-up sampling and will allow a PWS 
to ``guess assess'' the cause of the positive sample.
    EPA agrees that there already is some level of assessment and 
corrective action being performed voluntarily by proactive systems, and 
accounted for this fact in the economic analyses for the final RTCR 
(see chapter 7.4.5 of the RTCR EA (USEPA 2012a), Assessments). However, 
not all systems are proactive in addressing the probable cause(s) of 
the positive samples. Under the 1989 TCR, when a system has an MCL 
violation and any subsequent sampling did not detect total coliforms, 
the problem may persist despite the subsequent negative samples due to 
the intermittent nature of microbial contamination and may remain 
unaddressed. By requiring PWSs to assess their systems when they are 
triggered to do so, the RTCR aims to build and strengthen the 
capability of PWSs in ensuring that their systems maintain their 
integrity and that barriers are in place and are effective. These 
actions will better protect public health than the additional 
monitoring with no assessment and corrective action that is allowed 
under the 1989 TCR.
    EPA acknowledges that small systems, especially small NCWSs may not 
have the knowledge and the resources that other systems, like CWSs, 
have. However, most small NCWSs are simple systems that often consist 
of just the source water and a limited distribution system. EPA 
anticipates then that the level of effort and expertise needed to 
conduct a Level 1 assessment at these systems will not be considerable. 
At a minimum, the Level 1 assessment should be conducted or managed by 
a responsible party of the PWS. While EPA does not expect the Level 1 
assessor to be an expert in the requirements of SDWA, the assessor 
should be someone familiar enough with the system to answer the 
questions in the Level 1 assessment form or to gather correct 
information from others who work for the system.
    To help in the implementation of the assessment, a PWS may conduct 
a Level 1 assessment while it consults with the State by phone. This is 
in lieu of having the State physically perform the assessment when the 
PWS needs assistance. Generally, the PWS would still need to fill-out 
the assessment form and submit it to the State. The State would still 
need to review the form but the process will not take as much effort as 
previously anticipated since the State would already be familiar with 
that particular assessment. It is also permissible that the State fill 
out the form while the PWS consults with the State by phone when doing 
the assessment. The State may also want to set up alternative methods 
for the PWS to submit the assessment form, such as via an online 
submission or email. The State should document its process in the 
primacy application.
    EPA disagrees that the assessment requirements will reduce follow-
up sampling. PWSs are still required to take repeat samples following a 
routine total coliform-positive sample. PWSs on quarterly or annual 
monitoring must conduct additional routine monitoring the month 
following the total coliform-positive sample. In addition, nothing in 
the treatment technique requirements precludes a PWS from taking 
additional compliance samples or special purpose samples such as those 
taken to determine whether disinfection practices are sufficient 
following pipe replacement or repairs (see Sec.  141.853(b) of the 
RTCR).
    EPA disagrees that PWSs conducting the assessment will ``guess 
assess'' the cause of the positive samples. Conducting an assessment is 
a methodical process that requires a PWS to evaluate the different 
elements of its operation and distribution system (Sec.  141.859(b)(2) 
of the RTCR specifies the minimum elements that an assessment must 
have, keeping in mind that some of the elements may not be applicable 
to some PWSs like small NCWSs). The RTCR requires that an assessment 
form be completed. The assessment form should help and guide the PWS in 
conducting the assessment by laying out the different elements the PWS 
must look into. EPA provides examples of assessment forms that States 
and PWSs can use to help them in conducting the assessment (these 
examples are given in Appendix X of the AIP (USEPA 2008c) and in 
Appendix A of the Proposed Revised Total Coliform Rule Assessments and 
Corrective Actions Guidance Manual--Draft (USEPA 2010d)). EPA also 
acknowledges that an assessment will not always identify sanitary 
defects or find a reason or cause for the presence of total coliforms 
and/or E. coli. In such cases, the PWS must document that fact in the 
completed assessment form. This, however, is not ``guess assessing'' as 
EPA expects that only PWSs that adhere to proper procedures and 
standards set by the State are eligible to arrive at this 
determination. It is then the responsibility of the State to determine 
if the assessment was acceptable.
    Some commenters suggested that for systems with limited 
distribution systems that have a first Level 1 trigger, the Level 1 
assessment should be delayed and the focus of the evaluation should be 
on the source water, and the Level 1 assessment should only be 
conducted if there is another Level 1 trigger.
    The system may conduct an integrated assessment that meets the 
requirements of all applicable rules, such as the GWR and the RTCR, as 
long as the assessment is consistent with any State directives that 
tailor specific assessment elements with respect to the size and type 
of the system and the size, type, and characteristics of the 
distribution system, as required under Sec.  141.859(b)(2) of the RTCR. 
EPA further notes that source water issues are one of the elements that 
need to be considered in a Level 1 (or 2) assessment where they may be 
a contributing factor to a coliform exceedance or other trigger. EPA 
expects that assessments at PWSs

[[Page 10291]]

with limited or no distribution systems will be relatively simple 
assessments and can be tailored to meet applicable requirements of both 
the GWR and the RTCR. EPA will address this in the revised Revised 
Total Coliform Rule Assessment and Corrective Actions Guidance Manual 
that is being developed.
    EPA received comments both in support and against having two levels 
of assessment. The commenters in the second category concluded that 
both levels of assessment would involve the same effort. There were 
comments to eliminate the Level 1 assessment and emphasize the Level 2 
assessment, as the Level 1 assessment will not lead to any meaningful 
evaluation and will only take up the State's resources. EPA disagrees 
that there is no need for two levels of assessment. The RTCR requires 
two levels of assessment to recognize that a higher level of effort to 
diagnose a problem should be applied to situations of greater potential 
public health concern such as repeated Level 1 triggers or an E. coli 
MCL violation. A Level 1 assessment is not as comprehensive as Level 2 
assessment. This however, does not negate the importance of a Level 1 
assessment. Triggers that lead to a Level 1 assessment may indicate the 
possibility of a breach of the barriers in place. It is important that 
PWSs ensure that these barriers remain intact by performing the 
assessment.
    EPA received comments that the qualifications of assessors are not 
clear in the rule. The commenters suggested including the 
qualifications in the rule or referencing the qualifications described 
in the Proposed RTCR Assessment and Corrective Actions Guidance 
Manual--Draft (USEPA 2010d). Some commenters concluded that the Level 2 
assessment will require a whole new certification program for 
assessors. Others concluded that the States will end up doing the Level 
2 assessment because of what is expected and required of a Level 2 
assessment. On the other hand, one commenter suggested that a system 
operator should be certified to perform an assessment of their own 
system. Another suggested that States be allowed to set mechanisms in 
place to ensure that a Level 2 assessment is performed more 
comprehensively than a Level 1 assessment.
    EPA does not require that a separate certification program be 
established to determine who can perform a Level 2 assessment. Instead 
of being prescriptive on who can conduct a Level 2 assessment, EPA is 
allowing the State to determine its criteria and process for approval 
of Level 2 assessors and to determine who is appropriate to conduct the 
assessment given the State's knowledge of the complexity of the system 
and the knowledge and policies of the State. Although the rule allows 
that certified operators may perform a Level 2 assessment if approved 
by the State, EPA recommends that States consider whether having the 
assessment done by someone from outside the system can provide a fresh 
perspective. Qualified certified operators can be allowed to conduct 
assessments at other systems.
    EPA requested comments on how to ensure that a Level 2 assessment 
is more comprehensive than a Level 1 assessment (e.g., by possibly 
including asset management and capacity development). EPA asked in the 
proposed rule whether EPA should provide more detail in guidance or 
rule language, on the elements and differences between a Level 1 and 
Level 2 assessment. A majority of the commenters were against the 
inclusion of asset management and capacity development in the Level 2 
assessment. EPA received comments stating that the proposed rule 
language regarding the two levels of assessment was adequate and that 
additional discussion about the differences between the two should 
instead be addressed in guidance. One commenter, on the other hand, 
said that there was no difference in the scope between the two 
assessments based on the way the proposed rule language was written.
    EPA defined in Sec.  141.2 both a Level 1 assessment and a Level 2 
assessment to provide a better distinction between the two levels of 
assessment and facilitate the implementation of the RTCR. See section 
III.A.1 of this preamble, Assessment, for the definitions of a Level 1 
and Level 2 assessment. EPA is also requiring States to describe in 
their primacy application how they will ensure that a Level 2 
assessment is more comprehensive than a Level 1 assessment; thus, 
giving the States more flexibility in implementing the rule. EPA 
released the Proposed Revised Total Coliform Rule Assessments and 
Corrective Actions Guidance Manual--Draft (USEPA 2010d) in August 2010 
to help stakeholders understand the difference between the two levels 
of assessment. EPA will revise this guidance manual based on the 
comments received and release it soon after the final RTCR is published 
in the Federal Register.
    EPA received comments to allow the extension of the assessment 
period beyond 30 days. A commenter suggested that intermediate 
deadlines for a Level 2 assessment triggered by the presence of E. coli 
be included because of the acute nature of the threat.
    EPA expects that the PWS will conduct an assessment as soon as 
practical after the PWS receives notice or becomes aware that the 
system has exceeded a trigger. EPA imposes a 30-day limit because the 
possible occurrence of contamination, as indicated by the conditions 
that trigger the assessment, must be addressed immediately. The system 
has 30 days from the time it learns of exceeding the trigger to conduct 
the assessment and complete the corrective action. EPA believes that 
the 30-day period is sufficient time for problem identification and 
potential remediation of the problem in conjunction with the follow-up 
assessment in most cases. The system can work out a schedule with the 
State to complete the corrective action if more time is needed. It is 
very important, however, that the assessment is conducted as soon as 
possible within those 30 days. In the case of an E. coli MCL violation, 
the system must comply with any expedited actions or additional actions 
required by the State (see Sec.  141.859(b)(4) of the RTCR). EPA also 
encourages PWSs to submit their completed assessment forms as soon as 
possible and not wait until the end of the 30-days to do so.
3. Corrective Action
    a. Requirements. Under the RTCR, PWSs are required to correct 
sanitary defects found through either a Level 1 or Level 2 assessment. 
Systems should ideally be able to correct any sanitary defects found in 
the assessment within 30 days and report that correction on the 
assessment form. This is especially important when E. coli has been 
detected in samples collected from the distribution system, indicating 
that a potential health hazard exists. However, EPA recognizes that 
correcting sanitary defects within 30 days may not always be possible 
due to the extent and cost of the corrective action, and that some 
systems therefore may not be able to fix sanitary defects before 
submitting the completed assessment form within the 30-day interval. 
When the correction of sanitary defects is not completed by the time 
the PWS submits the completed assessment form to the State, EPA 
encourages the State and PWS to work together to determine the 
appropriate schedule for corrective actions (which may include 
additional or more detailed assessment or engineering studies) to be 
completed as soon as possible. The schedule, which is approved by the 
State, must include when the corrective action will be completed and 
any

[[Page 10292]]

necessary milestones and temporary public health protection measures. 
The PWS must comply with this schedule and notify the State when each 
scheduled corrective action is completed.
    At any time during the assessment or corrective action phase, 
either the PWS or the State may request a consultation with the other 
entity to discuss and determine the appropriate actions to be taken. 
The system may consult with the State on all relevant steps that the 
system is considering to complete the corrective action, including the 
method of accomplishment, an appropriate timeframe, and other relevant 
information. EPA is not requiring this to be a mandatory consultation 
to provide ease of implementation for States. In many cases, 
consultation may not be necessary because the type of corrective action 
for the sanitary defect will be clear and can be implemented right away 
(e.g., replacement of a missing screen).
    b. Key issues raised. EPA received comments that not all sanitary 
defects should have to be corrected unless it can be determined the 
defect directly correlates to the trigger or if the defect is otherwise 
regulated. Similarly, commenters suggested that EPA clarify that any 
requirement to correct sanitary defects found during the assessment be 
limited only to issues that are within the system's control. In 
contrast, one commenter encouraged EPA to provide authority to States 
to require broader corrective actions beyond fixing specific sanitary 
defects (e.g., requiring development and implementation of a storage 
tank inspection and maintenance plan).
    EPA acknowledges that it may or may not be possible to conclusively 
link the total coliform-E. coli-positive sample to a given sanitary 
defect due to the complexity of the distribution system configuration 
and transport of contaminants throughout the system. That being the 
case, the PWS must still correct all sanitary defects found through the 
assessment even if the defect cannot be proven to be the likely cause 
of the positive sample, to prevent the defect from providing a pathway 
for future contamination. The RTCR takes a more preventive approach to 
protect public health by requiring that systems perform an assessment 
of their system when their monitoring results indicate a potential 
pathway of contamination into the distribution system, or a breach in 
the barriers that are in place, and correct all identified sanitary 
defects, regardless of whether the defect is directly related to the 
positive sample or not. This is because EPA believes that correcting 
only sanitary defects that are correlated to the positive sample is not 
sufficiently protective of public health. Uncorrected sanitary defects 
may provide a pathway for future incidences of contamination.
    The RTCR requires that sanitary defects be corrected but does not 
mandate how the defects are to be corrected. States and PWSs may have 
other authorities under local ordinances and State laws that they may 
use to address the problem. For example, in cases where the location of 
the sanitary defect is outside the normal control of the PWS (e.g., 
cross connection occurring on private property), community water 
systems that are part of the local government may have some authority 
to address the problem under the public health code if the issue is 
affecting the water in the distribution system (AWWA 2010) or through 
other local ordinances such as plumbing codes. EPA encourages States 
and PWSs to work together to determine the best course of action when 
correcting sanitary defects.
    Some commenters said that it is unclear how a water utility should 
demonstrate that it has corrected a sanitary defect and how the primacy 
agency would take enforcement action on any defects identified by the 
system. One commenter suggested that EPA clarify whether a sanitary 
defect would be considered corrected if subsequent samples are total 
coliform-negative. EPA notes that because of the intermittent nature of 
microbial contamination, it may not be adequate to just rely on follow-
up samples to verify that the problem has been corrected or has gone 
away. Depending on the nature of the sanitary defect, States may 
require additional measures to ensure that the integrity of the 
distribution system has been restored (e.g., pressure monitoring, 
follow-up inspection of tanks, etc.). States have discretion on how to 
determine that defects have been corrected (e.g., site visits, sanitary 
surveys, etc.). Failure to correct identified sanitary defects is a 
treatment technique violation and States are expected to use their 
legal authority to take enforcement action to return the system to 
compliance.

F. Violations

1. Requirements
    EPA is establishing the definition of the following violations--MCL 
violation, treatment technique violation, monitoring violation, and 
reporting violation--consistent with the proposed RTCR. Each type of 
violation requires public notice, the level of which depends on the 
severity of the violation (see section III.G of this preamble, 
Providing Notification and Information to the Public, for information 
on public notification), and may trigger a system on reduced monitoring 
to increase its monitoring frequency (see section III.C of this 
preamble, Monitoring, for information on monitoring frequency). In 
addition to these violations, systems are required to comply with all 
the requirements of the RTCR, e.g., to use an approved analytic method 
to test for total coliforms and E. coli, to monitor according to a 
sample siting plan, etc. EPA also would like to clarify that exceeding 
a trigger and being required to conduct an assessment is not a 
violation by itself; as described later in this section, a violation 
occurs when a system exceeds the trigger but does not complete the 
required assessment and corrective action in response.
    a. E. coli MCL violation. A system incurs an E. coli MCL violation 
if any of the following occurs:
     A routine sample is total coliform-positive and one of its 
associated repeat samples is E. coli-positive.
     A routine sample is E. coli-positive and one of its 
associated repeat samples is total coliform-positive.
     A system fails to take all required repeat samples 
following a routine sample that is positive for E. coli.
     A system fails to test for E. coli when any repeat sample 
tests positive for total coliforms.
    b. Coliform treatment technique violation. A system incurs a 
coliform treatment technique violation when any of the following 
occurs:
     A system fails to conduct a required assessment within 30 
days of notification of the system exceeding the trigger (see section 
III.E of this preamble, Coliform Treatment Technique, for conditions 
under which monitoring results trigger a required assessment).
     A system fails to correct any sanitary defect found 
through either a Level 1 or 2 assessment within 30 days (see also 
section III.E of this preamble, Coliform Treatment Technique) or in 
accordance with State-derived schedule.
     A seasonal system fails to complete a State-approved 
start-up procedure prior to serving water to the public. This is 
further discussed later on in the Key issues raised part of this 
section.
    There is no treatment technique violation associated solely with a 
system exceeding one or more action triggers (Level 1 or Level 2 
triggers).
    c. Monitoring violation. A system incurs a monitoring violation 
when any of the following occurs:

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     A system fails to take every required routine or 
additional routine sample in a compliance period.
     A system fails to test for E. coli following a routine 
sample that is total coliform-positive.
    d. Reporting violation. A system incurs a reporting violation when 
any of the following occurs:
     A system fails to timely submit a monitoring report or a 
correctly completed assessment form after it properly monitors or 
conducts an assessment by the required deadlines. The PWS is 
responsible for reporting this information to the State regardless of 
any arrangement with a laboratory.
     A system fails to timely notify the State following an E. 
coli-positive sample. See section III.H.1.a of this preamble, 
Reporting, for reporting requirements in the case of an E. coli-
positive sample.
     A seasonal system fails to submit certification of 
completion of State-approved start-up procedure. This is further 
discussed in the Key issues raised part of this section.
2. Key Issues Raised
    EPA received comments that supported the proposed definition of the 
violations. Others offered suggestions to ease implementation burden. 
For example, one commenter recommended that only one violation be 
generated for each compliance situation (i.e., if an MCL violation is 
determined, then neither treatment technique, nor monitoring, nor 
reporting violation can be generated; if a treatment technique 
violation is determined, then neither monitoring nor reporting 
violation can be generated). However, EPA believes that it is important 
to track each of these situations individually so that the State can be 
aware of the system's progress resolving situations and complying with 
all rule requirements. Each situation is also accompanied by public 
notification requirements so that consumers can be aware of problems at 
the water system and the progress and efforts to correct them. EPA 
believes it is important to continue to notify the public of each 
situation.
    Some commenters were uncertain about when failure to take all 
repeat samples triggers the associated Tier 1 PN (i.e., when the 24-
hour clock starts). Some questioned how the State will know when the 
failure to collect these repeats has occurred in such a way to assure 
timely Tier 1 PN when the sample results do not need to be reported 
until the 10th day of the month following the month in which the 
samples were collected. EPA believes that State programs have been 
designed to address timely response to follow-up requirements such as 
the need to take repeat samples, through education, compliance 
assistance, and tracking and enforcement programs. The time limit is 
established to assure that systems act promptly to investigate positive 
samples. Some States require direct electronic reporting of results, 
which provides for more timely notification, and EPA encourages such 
practice. In the situations where it is not possible for the system to 
take the repeat samples within 24 hours, States have the discretion to 
waive the requirement (see section III.D of this preamble, Repeat 
Samples).
    Other commenters suggested adding to the list of violations. EPA 
received comment that there should be a violation when a seasonal 
system fails to perform the start-up procedure. EPA agrees and is 
designating such failure as a treatment technique violation. EPA is 
also requiring seasonal systems to certify that they have completed the 
start-up procedure and submit this certification to the State. Failure 
to do so is a reporting violation. EPA believes that performing start-
up procedures is very important to mitigate the possible risks 
resulting from the seasonal system being shutdown, depressurized, or 
drained. Designating such failure as a violation will compel seasonal 
systems to make sure that they take the necessary steps to mitigate 
public health risks before serving water to the public.
    Other commenters, on the other hand, suggested deleting the MCL 
violation resulting from failure to take all required repeat samples 
following a routine E. coli-positive sample. One commenter suggested 
that instead of an MCL violation, this should be considered a sanitary 
defect that requires corrective action. EPA considers E. coli as an 
indicator of a potential pathway of fecal contamination that should be 
taken seriously. A system needs to follow up with repeat samples to 
characterize the extent and source of such contamination. Failure to 
take the required repeat samples following an initial E. coli-positive 
sample is not protective of public health and is a serious violation. 
Making such failure an E. coli violation prevents a system from 
incurring only a monitoring violation when there is an indication of 
fecal contamination.
    Some commenters do not agree with the treatment technique violation 
because they do not agree that the treatment technique requirements of 
the RTCR are appropriate. For a discussion on the treatment technique, 
see section III.E of this preamble, Coliform Treatment Technique. One 
commenter asked for clarification on whether failure to submit the 
assessment form within 30 days is a treatment technique violation. As 
stated previously, this is a reporting violation, not a treatment 
technique violation, if the assessment has in fact been completed and 
the only failure was in submitting the required form. A treatment 
technique violation occurs when a potential pathway of contamination 
into the distribution system is unexplored and/or uncorrected. A system 
that neglects to perform the prescribed assessment or corrective action 
within schedule is in violation of the treatment technique requirement.
    Commenters also supported EPA's proposal of separating the combined 
monitoring and reporting violation under the 1989 TCR into two separate 
violations. One commenter noted that it has been difficult to determine 
the significance of a violation when two types of violations--
monitoring and reporting--are captured and reported under only one 
heading. It is, therefore, difficult to develop performance measures 
and ensure data quality when the two violations are combined.

G. Providing Notification and Information to the Public

1. Requirements
    EPA is promulgating changes to the public notification (PN) 
requirements contained in 40 CFR part 141 subpart Q to correspond to 
the violation provisions of the RTCR (see section III.F of this 
preamble, Violations). EPA is requiring a Tier 1 PN for an E. coli MCL 
violation, Tier 2 PN for a treatment technique violation for failure to 
conduct assessments or corrective actions, and a Tier 3 PN for a 
monitoring violation or a reporting violation.
    Tier 1 PN is required for NPDWR violations and situations with 
significant potential to have serious adverse effects on human health 
as a result of short-term exposure, such as could occur with exposure 
to fecal pathogens. Tier 1 PN is required as soon as possible but no 
later than 24 hours after the system learns of the violation. An E. 
coli MCL violation indicates possible exposure to pathogens in drinking 
water that can possibly result in serious, acute health effects, such 
as diarrhea, cramps, nausea, headaches, or other symptoms and possible 
greater health risks for infants, young children, the elderly, and 
people with severely compromised immune systems.
    In the 1989 TCR, if a system has an acute MCL violation, which is 
based on

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the presence of fecal coliforms or E. coli, or the system's failure to 
test for fecal coliforms or E. coli following a total coliform-positive 
repeat sample, the system is required to publish Tier 1 PN. Under the 
RTCR, a system is required to publish Tier 1 PN when it has an E. coli 
MCL violation. (See section III.F of this preamble, Violations, for a 
discussion of MCL violations.) In addition, the system will continue to 
be required to notify the State after learning of an E. coli-positive 
sample, as required under the 1989 TCR. As mentioned earlier in section 
III.B of this preamble, Rule Construct: MCLG and MCL for E. coli and 
Coliform Treatment Technique, EPA is eliminating the MCL for fecal 
coliforms. Under the RTCR, the standard health effects language, which 
is required to be included in all public notification actions, is 
modified to delete the reference to the fecal coliform MCL and fecal 
coliforms. The language for a non-acute violation under the 1989 TCR is 
modified to apply to a violation of the assessments and corrective 
action requirements of the coliform treatment technique.
    Tier 2 PN is required for all NPDWR violations and situations with 
potential to have serious adverse effects on human health not requiring 
Tier 1 PN. The system must provide public notice as soon as practical, 
but no later than 30 days after the system learns of the violation. A 
treatment technique violation under the RTCR meets these criteria 
because it is an indication that the public water system failed to 
protect public health when the system failed to conduct an assessment 
or complete corrective action following identification of sanitary 
defects. Sanitary defects indicate that a pathway may exist in the 
distribution system that has potential to cause public health concern.
    In the 1989 TCR, a system is required to publish a Tier 2 PN when 
the system has a non-acute MCL violation, which is based on total 
coliform presence. Under the RTCR, a system is required to publish a 
Tier 2 PN if the system violates the coliform treatment technique 
requirements. Also, EPA is modifying the standard health effects 
language for coliform to emphasize the assessment and corrective action 
requirements of the RTCR.
    Tier 3 PN is required for all other NPDWR violations and situations 
not included in Tier 1 or Tier 2. The existing Tier 3 PN requires a 
system to provide public notice no later than one year after the system 
learns of the violation or situation or begins operating under a 
variance or exemption. Monitoring and reporting violations have 
historically been designated as Tier 3 PN unless an immediate public 
health concern has been identified (e.g., failure to monitor for E. 
coli after a total coliform-positive sample requires a Tier 1 
notification.) Where no such immediate public health concern has been 
identified, EPA believes that a public notice given at least annually 
for monitoring and reporting violations fulfills the public's right-to-
know about these violations.
    In the 1989 TCR, a system is required to publish a Tier 3 PN when 
the system has a monitoring and reporting violation. In the RTCR, 
monitoring violations are considered distinct from reporting 
violations. Both types of violations require Tier 3 PN.
    Consumer confidence report (CCR) requirements are also modified. 
Health effects language for the CCR for total coliforms and E. coli, 
which is identical to the health effects language required for PN, is 
updated in the same way as described for PN. In addition, the RTCR 
removes the CCR requirements for the inclusion of total numbers of 
positive samples, or highest monthly percentage of positive samples for 
total coliforms as well as total number of positive samples for fecal 
coliforms. These provisions are replaced by requirements to include the 
number of Level 1 and Level 2 assessments required and completed, the 
number of corrective actions required and completed, and the total 
number of positive samples for E. coli. A system that fails to complete 
all the required assessments or correct all identified sanitary defects 
has a treatment technique violation and must identify it in the CCR as: 
(1) Failure to conduct all of the required assessment(s); and/or (2) 
failure to correct all identified sanitary defects. A system that has 
an MCL violation must also include the condition that resulted in the 
MCL violation (see section III.B.1 of this preamble, MCLG and MCL, and 
Sec.  141.860(a) of the RTCR). Unchanged and consistent with the 
provisions under the 1989 TCR, a CWS may provide Tier 3 PN using the 
annual CCR.
    CCR 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 RTCR. Because the RTCR no 
longer includes the total coliform MCL but now includes a trigger, EPA 
believes that systems no longer need to report the number of total 
coliform-positive samples via the CCR, since that could cause confusion 
or inappropriate changes in behavior among consumers. In addition, the 
CCR requirements will also reflect the removal of fecal coliform.
2. Key Issues Raised
    In general, EPA received comments in support of the PN requirements 
of the RTCR. The commenters stated that the changes are consistent with 
the intent and recommendations of the TCRDSAC. However, there were a 
few commenters who disagreed on certain aspects of the requirements. 
These comments are discussed in detail in the following paragraphs.
    EPA requested comment on whether the elimination of the PN 
associated with the presence of total coliforms (i.e., the Tier 2 PN 
associated with the non-acute MCL violation under the 1989 TCR) will 
result in a loss of information to consumers. Although the majority of 
the commenters said that it would not result in a loss of information, 
some commenters said that it would. One commenter said that the PN 
associated with the presence of total coliforms has been an effective 
tool to motivate PWSs to take corrective actions; to eliminate such PN 
and replace it with a PN associated with treatment technique violations 
is not ``equal to or better'' public health protection. One commenter 
believed that if the non-acute PN requirement is eliminated, then NCWSs 
would not have the tool to communicate to the public the possible 
health risk as these PWSs are not required to send out a CCR.
    As EPA discussed in section III.B of this preamble, Rule Construct: 
MCLG and MCL for E. coli and Coliform Treatment Technique, the presence 
of total coliforms is not, by itself, a public health threat. EPA 
agrees with comments received that suggest that the Tier 2 PN for a 
non-acute MCL violation under the 1989 TCR is sometimes unnecessarily 
alarming as it attributes greater public health significance to the 
presence of total coliforms than is warranted. EPA believes the removal 
of the Tier 2 PN for a non-acute MCL violation will help prevent public 
confusion.
    EPA received comments that under the 1989 TCR some States require a 
Tier 1 PN when a NCWS has a non-acute MCL violation. EPA would like to 
note that the 1989 TCR requires a Tier 2 PN for a non-acute MCL 
violation, not a Tier 1 PN. Some States using their own authority have 
chosen to elevate the PN

[[Page 10295]]

level to Tier 1 for a non-acute MCL in some or all cases. In certain 
circumstances, some States use this elevated PN in association with 
other follow-up actions involving agreements with other State and local 
agencies, to provide a more comprehensive and immediate response to 
potential public health threats, or to make the most efficient use of 
their existing authorities to protect public health. It is not EPA's 
intent to take this discretion away from the States, or to undermine 
these cooperative agreements with other State and local agencies. If a 
State deems that a given situation calls for a more elevated level of 
PN, or requires a more immediate action to ensure that public health is 
protected, then they can do so under their own discretion and 
authority. For example, the Level 2 assessment requirements in Sec.  
141.859(b)(4) allow States to require expedited actions or additional 
actions to ensure that public health is protected.
    EPA notes that NCWSs are required, like CWSs, to publish a PN, 
either a Tier 1, Tier 2, or Tier 3, depending on the violation. Even if 
they are not required to issue a CCR, NCWS must provide PN in other 
forms or methods consistent with the requirements of 40 CFR 141.153. 
States can also direct the PWS to perform additional public health 
measures (e.g., boil water orders, elevated PNs, etc.) as allowed under 
SDWA and the authority granted to them by their own legislation similar 
to EPA's authority under section 1431 of SDWA.
    EPA requested comment on whether to require special notice to the 
public of sanitary defects similar to the special notice requirements 
for significant deficiencies under the GWR. Most commenters were 
against including such provision. They stated that it would cause 
confusion and unnecessary alarm to customers. Several commenters noted 
that it is not appropriate for sanitary defects under the RTCR to have 
similar notice requirements as that of significant deficiencies under 
the GWR. The special notice requirement for significant deficiencies 
under the GWR only applies to NCWSs since they are not required to send 
out a CCR. EPA agrees that no special notice of sanitary defects is 
necessary and is not including such provision in the RTCR.
    EPA received comments suggesting modifications to the standard PN 
and CCR health effects language regarding total coliforms and the 
treatment technique violations included in the proposed RTCR. EPA has 
modified the standard health effects language found in Subpart O and 
Subpart Q of part 141 to make the language consistent with the use of 
total coliforms in the RTCR as an indicator of a potential pathway 
through which a contamination can enter the distribution system.

H. Reporting and Recordkeeping

1. Requirements
    a. Reporting. In addition to the existing general reporting 
requirements provided in 40 CFR 141.31, the RTCR requires a PWS to:
     Notify the State no later than the end of the next 
business day after it learns of an E. coli-positive sample.
     Report an E. coli MCL violation to the State no later than 
the end of the next business day after learning of the violation. The 
PWS must also notify the public in accordance with 40 CFR part 141 
subpart Q.
     Report a treatment technique violation to the State no 
later than the end of the next business day after it learns of the 
violation. The PWS must also notify the public in accordance with 40 
CFR part 141 subpart Q.
     Report monitoring violations to the State within ten days 
after the system discovers the violation, and notify the public in 
accordance with 40 CFR part 141 subpart Q.
     Submit completed assessment form to the State within 30 
days after determination that the coliform treatment technique trigger 
has been exceeded.
     Notify the State when each scheduled corrective action is 
completed for corrections not completed by the time of the submission 
of the assessment form.
     A seasonal system must certify that it has completed a 
State-approved start-up procedure prior to serving water to the public.
    EPA is adding the submission of the assessment form and the 
certification of completion of start-up procedure to the reporting 
requirements under Sec.  141.861 of the RTCR for better clarity and 
ease of tracking compliance. In the proposed rule, the submission of 
the assessment form is found only in Sec.  141.859, Coliform treatment 
technique requirements for protection against potential fecal 
contamination. The inclusion of the submission of the assessment form 
in Sec.  141.861 does not impose additional requirements beyond those 
that are imposed by the treatment technique requirements (see section 
III.E of this preamble, Coliform Treatment Technique, for discussion on 
the treatment technique requirements). Failure to submit the assessment 
form or the certification is a reporting violation as discussed in 
section III.F.1.d of this preamble, Reporting violation.
    b. Recordkeeping. EPA is maintaining the requirements regarding the 
retention of sample results and records of decisions related to 
monitoring schedules found in 40 CFR 141.33, and including provisions 
that address the new requirements of the RTCR pertaining to reduced and 
increased monitoring, treatment technique, etc. In addition, systems 
are required to maintain on file for State review the assessment form 
or other available summary documentation of the sanitary defects and 
corrective actions taken. Systems are required to maintain these 
documents for a period not less than five years after completion of the 
assessment or corrective action. Since systems have to maintain these 
files no less than five years, which is the maximum period allowed 
between sanitary surveys (i.e., five years; see 40 CFR 142.16(b)(3) and 
40 CFR 142.16(o)(2)), States have the opportunity to review these files 
during sanitary surveys and/or annual visits. The five-year period is 
also consistent with the recordkeeping requirements for microbiological 
analyses under 40 CFR 141.33(a).
    The system must also maintain a record of any repeat sample taken 
that meets State criteria for an extension of the 24-hour period for 
collecting repeat samples.
2. Key Issues Raised
    EPA received comments that support the reporting and recordkeeping 
requirements proposed by EPA. Most commenters said that the timeframes 
are appropriate and are consistent with EPA's practice regarding 
reporting and recordkeeping requirements in other regulations under 
SDWA. One commenter, however, said that EPA should standardize the 
recordkeeping requirements in all its rules, including the RTCR, for a 
period equal to the compliance cycle (i.e., nine years). The commenter 
adds that by standardization and being consistent with the compliance 
cycle, all monitoring and compliance records including corrective 
actions will be easily maintained, tracked, and available for State's 
inspections without the confusion of varying recordkeeping durations 
with different regulations. However, EPA's suite of drinking water 
regulations addresses different kinds of contaminants with different 
inherent characteristics, occurrence, and health effects. Because of 
these differences, monitoring of these contaminants occurs at different 
frequencies; hence, different reporting and recordkeeping requirements. 
The reporting and recordkeeping requirements specific to a

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drinking water regulation are therefore meant to support the 
implementation of that regulation. If possible, EPA makes every effort 
to ensure consistency of requirements across the drinking water 
regulations.

I. Analytical Methods

1. AIP-Related Method Issues
    a. Evaluation of currently approved methods. The AIP recommended 
that the Agency conduct a reevaluation of all the approved methods to 
ensure continued approval was warranted. In the proposed rule, the 
Agency identified the Environmental Technology Verification (ETV) 
program as the preferred mechanism for conducting such an evaluation 
and solicited comments on the approach.
    Key issues raised. While several commenters expressed support for a 
method reevaluation study conducted through the ETV program, some 
commenters expressed concern regarding the use of this program. One 
commenter stated that the reevaluation study should meet criteria 
established by EPA, not an EPA-contractor, who would receive financial 
benefit from the method manufacturers for conducting the testing. This 
commenter further expressed concern with using the ETV program because 
``the intent of the ETV program was never to certify, approve, 
guarantee, or warrantee analytical technologies.'' This commenter also 
suggested that the ETV program does not have the resources to develop 
the protocol for the method re-evaluation study.
    A second commenter expressed concern that the ETV program was 
established to facilitate incorporation of commercially-ready test kits 
into the market, which differs from the task of determining what are 
appropriate performance criteria for SDWA compliance methods. This 
commenter also expressed concern that the ETV program has not generated 
rigorous enough product evaluations adequate to support approval of 
alternative analytical procedures.
    Lastly, this commenter also suggested that the ETV studies do not 
have the same level of independence in protocol development as other 
third party studies, stating that in ETV studies, reviewers modify the 
protocol at the beginning of each study, and that for the recent 
verification study, there was not a clear discussion between the study 
organizers and the technical review panel regarding development of the 
final test protocol.
    EPA will take the comments concerning the ETV program into 
consideration as the Agency develops a final approach to the 
reevaluation of methods. EPA notes that ETV work is accomplished 
through cooperative agreements between EPA and private non-profit 
testing and evaluation organizations. ETV partners verify performance 
claims but do not endorse, certify or approve technologies. EPA has the 
regulatory authority and the responsibility to approve/disapprove 
methods and typically does so based on a review of method performance 
data generated by third party laboratories. Testing under the ETV 
program is typically paid for by participating vendors.
    ETV expert panels typically include representatives from industry, 
academia, EPA, and other stakeholders and collaborators. The rigor of 
an ETV study is determined by the objectives of the study and the 
resources available. If such a study is conducted, EPA, by virtue of 
participation in the expert panel, would ensure that the study is 
rigorous enough to meet the Agency's needs.
    EPA held a series of three open technical webinars in fall 2010. 
Participants recommended the development of a coliform strain library. 
The Water Research Foundation has funded a project to accomplish this 
task and the Agency will be monitoring the progress of that work as it 
considers the appropriate course of action.
    b. Review of the ATP protocol. The AIP recommended that the Agency 
engage stakeholders in a technical dialogue in its review of the 
Alternate Test Procedure (ATP) microbiological protocol. The proposed 
rule described how EPA could use the study plan development from the 
aforementioned method reevaluation study as a starting point for 
discussions with stakeholders regarding the basis for evaluating new 
methods. The proposed rule also explained that the study plan, along 
with ``lessons learned'' from the reevaluation study, could be used as 
a model for a revised ATP protocol.
    Key issues raised. One commenter suggested that the protocol used 
in the method reevaluation study should be used as the revised ATP 
protocol. EPA intends to consider this recommendation as it decides how 
to move forward on revising the microbial test protocol.
    c. Approval of ``24-hour'' methods. The AIP recommended that EPA 
consider the approval of analytical methods that allow more timely 
(e.g., on the order of 24 hours) results. As expressed in the rule 
proposal, EPA has concern that the more rapid ``24-hour'' methods may 
not have the same recovery rates, especially for stressed or injured 
organisms, as the historic methods that allow for longer incubation 
times.
    Key issues raised. One commenter suggested that the Agency withdraw 
approval for the older approved methods that can require longer times 
to obtain results. EPA intends to consider this recommendation as it 
decides how to move forward.
    d. Elimination of fecal coliforms. As explained in the rule 
proposal, EPA plans to eliminate all provisions for fecal coliform 
monitoring under this regulation. No comments were received on this 
issue. As such, all provisions relating to fecal coliforms are removed 
in this final rule.
    e. Request for comment on other AIP-related method issues. i. 
Expedited results notification process. The proposed rule requested 
comment on whether the RTCR should include provisions to ensure a more 
expedited notification process. The RTCR could, for example, include 
language requiring that PWSs arrange to be notified of a positive 
result by their laboratory within 24 hours.
    Key issues raised. The Agency received many comments regarding this 
element of the proposed rule. Many commenters expressed support for 
this provision, with some States reporting that this provision is an 
existing component of their State regulations. Several commenters 
expressed that given the widespread availability of electronic 
communication it would be easy for a laboratory to notify the public 
water system quickly of the results of the sample analyses.
    Many comments expressed concern over the ability of the States to 
enforce such a provision. Additionally, several commenters noted that 
this provision would hold the water system accountable for the actions 
of the laboratory, which the public water system does not have 
immediate control over.
    EPA believes that the public is well served by timely reporting of 
results but recognizes some of the challenges associated with 
addressing this via regulation. Accordingly, the Agency intends to use 
guidance documents associated with this regulation to address this 
issue. Through the guidance documents, the Agency expects to urge 
public water systems to establish language in their contract with the 
laboratories requiring that the water system be notified by the 
laboratory within 24 hours of any positive results.
    Additionally, the Agency plans to encourage the certified 
laboratory community to ensure that laboratories

[[Page 10297]]

are aware of the importance of timely notification of any positive 
results to their clients.
    ii. Taking repeat samples within 24 hours. During the Advisory 
Committee meetings, the factors impacting the timeframe between a 
coliform detection and the collection of the repeat sample were 
discussed. It was noted that in some cases, repeat samples are not 
collected for several days after notification of a coliform detection. 
EPA requested comment in the proposed rule whether the RTCR should 
require repeat samples be taken within 24 hours of a total coliform-
positive with no (or limited) exceptions.
    Key issues raised. While some commenters expressed support for such 
a provision in the final rule, most commenters noted that the final 
RTCR should retain flexibility around this requirement, as allowed in 
the 1989 TCR.
    Several commenters noted that including such a provision in the 
final RTCR would create a hardship on systems, with many mentioning 
that weekend sample collection is a challenge for many small systems. 
Concern was expressed that this provision in the final rule would 
result in more monitoring violations but not necessarily change repeat 
sample collection practice.
    Based on consideration of the concerns expressed, EPA is not 
changing the provision that States may extend the 24-hour limit if the 
system has a logistical problem in collecting the repeat samples within 
24 hours that is beyond its control. See sections III.D of this 
preamble, Repeat Samples, for additional discussion.
2. Other Method Issues
    a. Holding time. In the proposed rule, EPA clarified the language 
defining when the sample holding time ends. The 1989 TCR states ``the 
time from sample collection to initiation of analysis may not exceed 30 
hours,'' and this language was clarified in the proposed rule to state 
``The time from sample collection to initiation of test medium 
incubation may not exceed 30 hours.''
    Key issues raised. Two comments were received on this rule 
provision, with one commenter explaining that some water systems have a 
difficult time meeting the 30-hour hold time, and this provision may 
further impact their ability to meet the holding time. The second 
commenter stated that the number of coliforms does not likely change in 
``a 30 minute window'' and that this provision will not improve public 
health.
    As explained in the proposed rule, EPA recognizes that this 
provision may slightly decrease the amount of time that a water system 
has to get the sample to the lab, by approximately 30 minutes or less. 
EPA believes the impact of this provision is minimal, as a well managed 
laboratory will be able to recognize a sample that is received near the 
end of the holding time and make this sample a priority for analysis.
    The inclusion of this provision in the final rule serves to ensure 
consistency in the analyses of the compliance samples on a national 
basis and will have a minimal impact on water systems. As such, the 
provision is included in the final rule.
    b. Dechlorinating agent. The proposed rule included a provision 
that would require the use of a dechlorinating agent when samples of 
chlorinated water are collected.
    Key issues raised. The Agency did not receive any adverse comment 
to this provision of the proposed regulation. Accordingly, this 
provision has been included in the final rule. EPA notes that the 
wording of this provision in the final rule differs slightly from that 
included in the proposed rule. The wording was changed to clarify that 
the use of a dechlorinating agent is applicable to water systems that 
use any type of chlorination (including chloramines) to disinfect their 
drinking water supplies. The proposed rule did not include language 
that was specific enough to ensure that this point was clear.
    c. Filtration funnels. In the proposed rule, EPA added a footnote 
to the methods table that clarifies that the funnels used in the 
membrane filtration procedure should be sterilized by autoclaving, not 
by using ultraviolet (UV) light. The addition of this provision to the 
rule makes the rule requirements consistent with what is recommended by 
the Agency in the Manual for the Certification of Laboratories 
Analyzing Drinking Water (EPA 815-R-05-004, 5th Edition, 2005).
    Key issues raised. The Agency only received one comment on this 
provision, requesting clarification that would allow the use of 
disposable filtration units that are purchased pre-sterilized by the 
manufacturer. EPA believes that these units can be appropriate for use 
in drinking water sample analyses, and therefore has modified the 
provision to reflect usage of such units. The provision now reads as 
follows:

    All filtration series must begin with membrane filtration 
equipment that has been sterilized by autoclaving. Exposure of 
filtration equipment to UV light is not adequate to ensure 
sterilization. Subsequent to the initial autoclaving, exposure of 
the filtration equipment to UV light may be used to sanitize the 
funnels between filtrations within a filtration series. 
Alternatively, disposable membrane filtration equipment that is pre-
sterilized by the manufacturer (i.e., disposable funnel units) may 
be used.

    d. Analytical methods table changes. The proposed rule reflected 
many modifications to the table of analytical methods to clarify which 
methods were approved for use under this regulation.
    No comments were received on the following changes to the methods 
table. Accordingly these modifications have been incorporated into the 
final rule.
     The table is organized by methodology.
     E. coli methods are included in the analytical methods 
table.
     The 18th and 19th editions of Standard Methods for the 
Examination of Water and Wastewater are no longer approved and are not 
included in the final rule.
     The references to Standard Methods 9221A and 9222A are 
removed.
     The reference to Standard Methods 9221B is changed to 
9221B.1, B.2.
     The reference to Standard Methods 9221D is changed to 
9221D.1, D.2.
     The citation for MI agar is changed to EPA Method 1604.
     The table clarifies that Standard Methods 9221 F.1 and 
9222 G.1c(1), and 9222 G.1c(2) may be used for E. coli analysis.
     The table clarifies the correct formulation for E. coli 
medium with 4-methylumbelliferyl-Beta-D-glucuronide (EC-MUG) broth, 
when used in conjunction with Standard Methods 9222G.1c(2), through the 
addition of the following footnote: The following changes must be made 
to the EC broth with MUG (EC-MUG) formulation: Potassium dihydrogen 
phosphate, KH2PO4 must be 1.5g and 4-methylumbelliferyl-Beta-D-
glucuronide must be 0.05 g.
     The table reflects the approval of a modified Colitag 
method for the simultaneous detection of E. coli and other total 
coliforms.
    The proposed rule also contained a provision to allow the use of 
Standard Methods 9221D in an enumerative format, specifically, in the 
multiple tube format as described in Standard Methods 9221B.
    Key issues raised. One comment was received, stating that the use 
of Standard Methods 9221D in an enumerative (multiple tube) format 
should be evaluated through an Alternate Test Procedure (ATP) study or 
be added to the proposed method reevaluation study. Given that this

[[Page 10298]]

method is a part of Standard Methods 9221, entitled ``Multiple-Tube 
Fermentation Technique for Members of the Coliform Group,'' the Agency 
believes it is appropriate for this method to be used in an 
enumerative, multiple tube format. Additionally, as explained in the 
proposed rule, there have been publications demonstrating that this 
method is effective in a multiple tube format.
    Since use of this method in a multiple-tube format does not change 
the formulation of the medium, nor the volume of sample analyzed, the 
Agency has determined that an ATP evaluation is not necessary. 
Therefore, the provision is included in the final rule.
    e. Holding temperature. In the proposed rule, the Agency requested 
comment as to whether the RTCR should require the samples to be held at 
10 degrees Celsius (C) or less during transit.
    Key issues raised. Several commenters expressed support for this 
provision stating that it would improve the integrity of the data 
collected under this rule. However, many commenters expressed concern 
that the addition of this provision would cause a hardship, especially 
to small systems, as it would increase the cost of the sample shipment. 
Additionally, concern was expressed that this provision would increase 
the number of ``failure to monitor'' violations, thereby imposing an 
enforcement burden on the States.
    Based on further consideration of the potential additional burden 
on both the PWSs and the States, EPA has determined that the provision 
in the 1989 TCR will stay as is: ``Systems are encouraged but not 
required to hold samples below 10 deg. C during transit.''
    Finally, in this final rule, there have been some further changes 
to the analytical methods table to improve its clarity. Such changes 
include the addition of the approved online versions of Standard 
Methods in the analytical methods table and correction of some clerical 
errors.

J. Systems Under EPA Direct Implementation

    Systems falling under direct oversight of EPA (e.g., Tribal 
systems, PWSs in Wyoming, and PWSs in States that have not yet obtained 
primacy for the RTCR) where EPA acts as the State, must comply with 
decisions made by EPA for implementation of the RTCR. Under Sec.  
142.16(q), to obtain primacy for the RTCR, States/Tribes are required 
to demonstrate how they intend to implement the various requirements of 
the rule; States/Tribes may do so in a manner that maximizes the 
efficiency of the rule for the States/Tribes and the PWSs while 
maintaining or increasing the effectiveness of the rule to protect 
public health. EPA has the same responsibilities when the Agency acts 
as the State in directly implementing the RTCR. In the proposed RTCR, 
EPA requested comment on whether to make this explicit in the final 
RTCR. All commenters who responded to this request for comment were in 
support of such action. EPA already has such authority or flexibility 
in direct implementation situations, both in the 1989 TCR and in all 
other NPDWRs, but solicited comment and has added this provision to the 
final rule for the sake of clarity in situations where EPA directly 
implements the RTCR.

K. Compliance Date

    Consistent with SDWA section 1412(b)(10), States and PWSs are given 
three years after the promulgation of the RTCR to prepare for 
compliance with the rule. PWSs must begin compliance with the 
requirements of the RTCR on April 1, 2016, a compliance effective date 
that is just over three years from promulgation and coincides with 
quarterly monitoring schedules applicable to many water systems. EPA 
believes that capital improvements generally are not necessary to 
ensure compliance with the RTCR. However, a State may allow individual 
systems up to two additional years to comply with the RTCR if the State 
determines that additional time is necessary for capital improvements, 
in accordance with SDWA section 1412(b)(10).

IV. Other Elements of the Revised Total Coliform Rule

A. Best Available Technology

1. Requirements
    EPA is making three modifications to the 1989 TCR provisions 
regarding the best technology, treatment techniques, or other means 
available for achieving compliance with the MCL for E. coli under the 
RTCR. EPA has re-designated these provisions from 40 CFR 141.63(d) to 
141.63(e) and is making the following modifications.
     ``Coliforms'' in 40 CFR 141.63(d)(1) under the 1989 TCR is 
replaced with ``fecal contaminants'' in 40 CFR 141.63(e)(1).
     ``Cross connection control'' is added to the list of 
proper maintenance practices for the distribution system in 40 CFR 
141.63(e)(3) (formerly 40 CFR 141.63(d)(3)).
     Subparts P, T, and W (filtration and/or disinfection of 
surface water), and subpart S (disinfection of ground water), are added 
in 40 CFR 141.63(e)(4) (formerly 40 CFR 141.63(d)(4)).
    The Agency is listing the same technology, treatment techniques, or 
other means available for achieving compliance with the MCL for E. coli 
as provided in Sec.  141.63(e), for small PWSs serving 10,000 or fewer 
people, as required by SDWA section 1412(b)(4)(E)(ii).
2. Key Issues Raised
    EPA received comments that supported the modifications to the list 
of best available technologies (BATs). The Agency also received 
comments suggesting the addition of other items to the list, such as 
the optional barriers that may qualify systems for reduced monitoring, 
unidirectional flushing, storage tank inspection, maintenance, and 
cleaning, and re-pressurization. EPA heard from a few commenters who 
are against the inclusion of cross connection control in the list of 
BATs. They stated that it is not appropriate to do so because EPA has 
not defined cross connection control, and risks associated with cross 
connection and backflow are being addressed in the research efforts of 
the Research and Information Collection Partnership (see http://water.epa.gov/lawsregs/rulesregs/sdwa/tcr/regulation_revisions_tcrdsac.cfm#ricp for additional information about the Partnership); 
hence, they concluded it is premature to include it in the RTCR.
    The methods for achieving compliance listed in 40 CFR 141.63(e) 
represent the technology, treatment technique, and other means which 
EPA finds to be feasible for purposes of meeting the MCL for E. coli, 
in accordance with section 1412(b)(4)(E) of SDWA. The RTCR however, is 
not imposing additional requirements (e.g., disinfection, filtration, 
etc.) beyond those already addressed by other microbial drinking water 
regulations such as the Ground Water Rule and the Surface Water 
Treatment Rules; nor is it imposing specific requirements regarding the 
use of the other methods such as main flushing programs, cross 
connection control, etc. PWSs are given the discretion to use the 
methods in 40 CFR 141.63(e) (if they are not already required to do 
so), or other methods of their choice (provided they are acceptable to 
the State), as they see fit for their own systems.
    EPA believes that the inclusion of cross connection control to the 
list of BATs is appropriate given the public health risk associated 
with unprotected cross connection. Several States already require that 
PWSs implement a cross connection control program. As

[[Page 10299]]

discussed in the previous paragraph, the inclusion of cross connection 
control in 40 CFR 141.63(e) does not impose specific requirements on 
PWSs to implement a cross connection control program. Rather, it 
acknowledges that cross connection control can be one of the tools PWSs 
can use to comply with the E. coli MCL.

B. Variances and Exemptions

1. Requirements
    EPA is not allowing variances or exemptions to the E. coli MCL in 
Sec.  141.4(a). EPA believes that water that exceeds the MCL for E. 
coli poses an unreasonable risk to public health. Therefore, EPA is not 
allowing any variances or exemptions to the E. coli MCL. EPA is also 
eliminating the variance provisions in Sec.  141.4(b) under the 1989 
TCR that allow systems to demonstrate to the State that the violation 
of the monthly/non-acute total coliform MCL is due to biofilm and not 
fecal or pathogenic contamination. This change also results in a 
parallel change in Sec.  142.63(b). Since the MCL for total coliforms 
is eliminated and replaced by a treatment technique, the variance for 
the presence of biofilms is no longer applicable and allowed under 
SDWA. Instead, the presence of biofilm is addressed through the 
assessment and corrective action requirements of the RTCR.
    EPA is adding a note to the provision in Sec.  141.4(a) to clarify 
that small system variances or exemptions for treatment technique 
requirements in this rule and other rules that control microbial 
contaminants may not be granted under SDWA section 1415(e)(6)(B) and 
Sec.  142.304(a). This action reflects the statutory provision within 
EPA's regulations and adds no new requirements or limitations to any of 
these rules.
2. Key Issues Raised
    Most commenters support these changes. However, EPA also received 
comment that supported the retention of the variance for the presence 
of biofilms. The commenter said that the retention of the biofilm 
variance would require PWSs to have a biofilm control program in place 
that will require ongoing assessment and research to determine and 
address the cause of the biofilms, thereby providing valuable 
information. Some commenters suggested that if the biofilm variance is 
removed, EPA should make it clear that the finding of biofilms as the 
cause of the positive sample during an assessment is not a sanitary 
defect which requires correction.
    As discussed previously in section IV.B.1 of this preamble, 
Requirements, EPA is not allowing variances to the E. coli MCL because 
EPA believes that water which exceeds the MCL for E. coli poses an 
unreasonable risk to public health. Furthermore, retention of the 
variance for total coliforms is not allowed under SDWA because the MCL 
for total coliforms is eliminated and replaced by a treatment 
technique. EPA believes that additional research and information 
collection will be valuable to learning about the magnitude of the 
risks from biofilms. However, research available to date indicates that 
biofilms can harbor pathogens and result in accumulation of 
contaminants (Brown and Barker 1999; Szewzyk et al. 2000; Berry et al. 
2006; L[aring]ngmark et al. 2007), and considering it a sanitary defect 
is warranted in some cases. Also, persistent biofilms that cause 
continued total coliform presence compromises the value of total 
coliforms as an indicator of potential pathways of contamination. If 
biofilm is determined to be the cause of the total coliform-positive 
samples that triggered an assessment, the PWS is encouraged to work 
with the State to determine the right course of action to address the 
biofilms. Under the RTCR, States have the discretion to determine if 
the completed assessment and corrective action are adequate. The State 
can use this discretion in addressing instances of biofilm presence and 
determining the extent of biofilm problems in the distribution system 
and the need to address them. When a system has an ongoing biofilm 
problem that continues to cause total coliform-positive samples, the 
system and the State can continue to take action until the biofilm 
problem is resolved.

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

    EPA recognizes that there are linkages among monitoring 
requirements between the 1989 TCR and other NPDWRs. For instance, under 
the Surface Water Treatment Rule (SWTR) (USEPA 1989b, 54 FR 27486, June 
29, 1989) and the Stage 1 Disinfectants and Disinfection Byproducts 
Rule (Stage 1 DBPR) (USEPA 1998a, 63 FR 69389, December 16, 1998), the 
residual disinfectant monitoring must be conducted at the same time and 
location at which total coliform samples are taken, as required. Under 
the SWTR, high measurements of turbidity in an unfiltered subpart H 
system (i.e., a system using surface water or ground water under the 
influence of surface water) trigger additional total coliform samples; 
and compliance with the total coliform MCL under the 1989 TCR is one of 
the criteria for a PWS to avoid filtration. Under the GWR, 1989 TCR 
distribution system monitoring results determine whether a system is 
required to conduct source water monitoring.
    For the criteria for avoiding filtration in the SWTR (Sec.  
141.71(b)(5)), the Agency is clarifying that unfiltered systems must 
continue to meet the E. coli MCL promulgated with the final RTCR at 
Sec.  141.63(c) in order to remain unfiltered. The changes to Sec.  
141.71(b)(5) provides for replacement of the (acute) total coliform MCL 
at Sec.  141.63(b) with the E. coli MCL at Sec.  141.63(c) at the 
compliance date of the RTCR. Although the name of the MCL has changed, 
the determination of the E. coli MCL remains basically the same as that 
for the (acute) total coliform MCL in Sec.  141.63(c), with the only 
changes being those that were made to address the advisory committee 
recommendations and the public comments.
    After considering other possible linkages between the RTCR and the 
SWTR, GWR, Stage 1 DBPR, Stage 2 DBPR (USEPA 2006e, 71 FR 388, January 
4, 2006), and Airline Drinking Water Rule (USEPA 2009), EPA has 
concluded that the only other necessary revision to these NPDWRs is to 
update the references to the 1989 TCR at 40 CFR 141.21, which is 
superseded by 40 CFR part 141 subpart Y beginning April 1, 2016. The 
monitoring requirements themselves are not changing as a result of the 
RTCR. Residual disinfectant samples must still be taken at the same 
time and location at which total coliform samples are taken under the 
RTCR. High measurements of turbidity under the SWTR would still result 
in additional total coliform samples. Results of total coliform 
monitoring under the RTCR would still be a trigger for the GWR. 
Although there are changes to the dual-purpose sampling requirement 
(i.e., one sample to satisfy both the repeat monitoring requirement of 
the RTCR and the triggered source water monitoring requirement of the 
GWR), these changes are addressed in the RTCR and not in the GWR (see 
section III.D of this preamble, Repeat Samples, for further discussion 
on dual-purpose sampling). Comments received on dual-purpose sampling 
are also discussed in section III.D of this preamble, Repeat Samples.
    EPA also received comments regarding the relationship between 
source water evaluations under the GWR and assessments under RTCR; 
those comments are addressed in section III.E.2 of this preamble, 
Assessment.
    The RTCR is also not changing the existing sanitary survey 
requirements

[[Page 10300]]

established under the IESWTR and the GWR. However, the RTCR is adding 
the special monitoring evaluation that States must conduct at systems 
serving 1,000 or fewer people during the sanitary survey. These 
evaluations are not expected to significantly increase the burden to 
conduct sanitary surveys because of the relatively simple nature of 
these systems and their monitoring requirements.
    EPA did not receive any other substantial comments regarding the 
relationships between RTCR and other NPDWRs.
    EPA recognizes that there are sections of part 141 that will no 
longer be applicable after the RTCR compliance effective date. EPA 
intends to review and update these sections in the future.

D. Storage Facility Inspection

    In the proposed RTCR, EPA discussed the potential public health 
implications associated with poorly maintained storage facilities (such 
as those associated with significant sediment accumulation inside the 
tank and the presence of breaches). EPA requested comment and 
supporting information regarding the current status of storage tanks 
and their inspection as implemented by individual States and PWSs. Some 
of the information EPA requested comment on included the state and 
condition of tanks that have been cleaned and inspected, costs of 
storage tank inspection and cleaning, the frequency of inspection and 
cleaning, and how public health can be better protected. Based on the 
comments and information that EPA received, the Agency is considering 
the need for inspection requirements for finished water storage 
facilities that would help mitigate potential public health risks if 
PWSs do not inspect their storage facilities as recommended by industry 
guidance (e.g., American Water Works Association (AWWA) Manual 42). EPA 
plans to provide further information on the results of its 
consideration of this issue in a future notice.

V. State Implementation

    SDWA establishes requirements that States or eligible Indian Tribes 
must meet to assume and maintain primary enforcement responsibility 
(primacy) to implement national primary drinking water regulations. 
This section describes the requirements that States must meet to 
maintain primacy under the RTCR, including adoption of drinking water 
regulations that are no less stringent than the RTCR and meeting 
recordkeeping and reporting requirements. This section also provides an 
update on the Safe Drinking Water Information System (SDWIS) revisions 
that EPA is developing to facilitate the implementation of RTCR.

A. Primacy

1. Requirements
    States are required to adopt or maintain requirements that are at 
least as stringent as all of the sections of 41 CFR part 141that are 
revised or added by the RTCR. SDWA provides two years after 
promulgation of the RTCR (plus up to two more years if the 
Administrator approves) for the State to adopt their regulations. 
States may adopt more stringent requirements (e.g., requiring all 
systems to conduct routine monthly monitoring). Many States have used 
this authority in the past to improve public health protection and/or 
simplify implementation.
    EPA grants interim primary enforcement authority for a new or 
revised regulation during the period in which EPA is making a 
determination with regard to primacy for that new or revised 
regulation. States that have primacy (including interim primacy) for 
every existing NPDWR already in effect may obtain interim primacy for 
the RTCR, beginning on the date that the State submits the application 
for this rule to EPA, or the effective date of its revised regulations, 
whichever is later. A State that wishes to obtain interim primacy for 
future NPDWRs must obtain primacy for this rule.
    EPA regulations at 40 CFR part 142 contain the program 
implementation requirements for States to obtain primacy for the public 
water supply supervision program as authorized under SDWA section 1413. 
In addition to adopting rule requirements that are at least as 
stringent as the requirements of the RTCR, and basic primacy 
requirements specified in 40 CFR part 142, States are required to adopt 
special primacy provisions pertaining to each specific regulation where 
State implementation of the rule involves activities beyond general 
primacy provisions. States must include these regulation-specific 
provisions in their application for approval of any program revision. 
States must also continue to meet all other conditions of primacy for 
all other rules in 40 CFR part 142.
    The RTCR provides States with flexibility to implement the 
requirements of the rule in a manner that maximizes the efficiency of 
the rule for the States and water systems while increasing the 
effectiveness of the rule to protect public health. To ensure an 
effective and enforceable program under the RTCR, the State primacy 
application for RTCR must include a description of how the State will 
meet the following special primacy provisions contained in the RTCR at 
40 CFR part 142:
     Baseline and Reduced Monitoring Provisions--The State 
primacy application must indicate what baseline and reduced monitoring 
provisions of the RTCR the State will adopt and describe how the State 
will implement the RTCR in these areas so that EPA can be assured that 
implementation plans meet the minimum requirements of the rule.
     Sample Siting Plans--States must describe the frequency 
and process used to review and revise sample siting plans in accordance 
with 40 CFR part 141, subpart Y to determine adequacy.
     Reduced Monitoring Criteria--The primacy application must 
indicate whether the State will adopt the reduced monitoring provisions 
of the RTCR (e.g., reduced monitoring provisions for ground water 
systems serving 1,000 or fewer people, including provisions on dual 
purpose sampling). If the State adopts the reduced monitoring 
provisions, it must describe the specific types or categories of water 
systems that will be covered by reduced monitoring and whether the 
State will use all or a reduced set of the optional criteria. For each 
of the reduced monitoring criteria, both mandatory and optional, the 
State must describe how the criteria will be evaluated to determine 
when systems qualify.
     Assessments and Corrective Actions--States must describe 
their process to implement the new assessment and corrective action 
phase of the rule. The description must include how the State will 
ensure that Level 2 assessments are more comprehensive than Level 1 
assessments, examples of sanitary defects, examples of assessment forms 
or formats, and methods that systems may use to consult with the State 
on appropriate corrective actions.
     Invalidation of routine and repeat samples collected under 
the RTCR--States must describe their criteria and process to invalidate 
total coliform-positive and E. coli-positive samples under the RTCR. 
This includes criteria to determine if a sample was improperly 
processed by the laboratory, reflects a domestic or other non-
distribution system plumbing problem or reflects circumstances or 
conditions that do not reflect water quality in the distribution 
system.
     Approval of individuals allowed to conduct RTCR Level 2 
assessments--States must describe their criteria and process for 
approval of individuals allowed to conduct RTCR Level 2 assessments.

[[Page 10301]]

     Special monitoring evaluation--States must describe how 
they will perform special monitoring evaluations during sanitary 
surveys for ground water systems serving 1,000 or fewer people to 
determine whether systems are on an appropriate monitoring schedule.
     Seasonal systems--States must describe how they will 
identify seasonal systems, how they will determine when systems on less 
than monthly monitoring must monitor, and what will be the seasonal 
system start-up provisions.
     Additional criteria for reduced monitoring--States must 
describe how they will require systems on reduced monitoring to 
demonstrate, where appropriate:

--Continuous disinfection entering the distribution system and a 
residual in the distribution system.
--Cross connection control.
--Other enhancements to water system barriers.

     Criteria for extending the 24-hour period for collecting 
repeat samples--If the State elects to use a set of criteria in lieu of 
case-by-case decisions, they must describe the criteria they will use 
to waive the 24-hour time limit for collecting repeat samples after a 
total coliform-positive routine sample, or to extend the 24-hour limit 
for collection of samples following invalidation. If the State elects 
to use only case-by-case waivers, the State does not need to develop 
and submit criteria.
2. Key Issues Raised
    Commenters generally supported the inclusion of these activities in 
the primacy application and emphasized the importance of the 
flexibility and discretion that this approach provides for States to 
build on existing authorities of the 1989 TCR and focus on systems with 
the greatest need. They suggested that EPA allow States as much 
flexibility and discretion as possible to design their approach to 
implementing the RTCR, including how to address seasonal water systems, 
qualifications of assessors, the content of sample siting plans, and 
compliance with multiple rules (e.g., coordination between 1989 TCR/
RTCR and GWR compliance), and how to consider multiple Level 1 
assessments where the cause of the first Level 1 assessment has been 
identified and corrected. However, some commenters suggested removal of 
some of the special primacy requirements, such as those regarding 
seasonal system startup procedures and how the States will review 
sample siting plans, implement the assessment and corrective action 
phase, and determine who is approved to conduct Level 2 assessments. 
EPA is maintaining these primacy requirements in the RTCR because they 
provide the States with the flexibility to design their programs to fit 
their own needs without prescriptive, one-size-fits-all requirements. 
Describing how the State will accomplish them in the primacy 
application assures that consumers nationwide are receiving adequate 
and comparable public health protection under the rule.
    EPA also requested comment on whether it is appropriate to have 
States describe their criteria for waiving or extending the 24-hour 
limit to collect repeat samples as a special primacy condition, or 
instead have States keep records of decisions to waive and/or extend 
the 24-hour limit. The majority of the commenters supported the former 
option as it reduces paperwork burden and adds flexibility to the 
implementation of the RTCR. EPA concurs and added the waiver or 
extension of the 24-hour limit to the special primacy requirements as 
an option for States that would rather describe their criteria for 
waiving or extending the 24-hour limit in their primacy application, 
instead of having to make the decision on a case-by-case basis. States 
that elect to use only case-by-case waivers do not need to develop and 
submit criteria.

B. State Recordkeeping and Reporting and SDWIS

1. Recordkeeping
    The current regulations in 40 CFR 142.14 require States with 
primacy to keep records, including: analytical results to determine 
compliance with MCLs, maximum residual disinfectant levels (MRDLs), and 
treatment technique requirements; PWS inventories; State approvals; 
enforcement actions; and the issuance of variances and exemptions. 
Consistent with the recordkeeping requirements of the current 
regulations, the RTCR requires States to keep records and supporting 
information for each of the following decisions or activities for five 
years:
     Any case-by-case decision to waive the 24-hour time limit 
for collecting repeat samples after a total coliform-positive routine 
sample, or to extend the 24-hour limit for collection of samples 
following invalidation.
     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 Sec. Sec.  141.854(j) and 141.855(f) of the RTCR.
     Any decision to invalidate a total coliform-positive 
sample. If the State decides to invalidate a total coliform-positive 
sample as provided in Sec.  141.853(c)(1) of the RTCR, the record of 
the decision must contain all the items listed in that paragraph.
    Also, consistent with the recordkeeping requirements of the current 
regulations, under the RTCR States must retain records of each of the 
following decisions in such a manner 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 Sec.  141.855(d) of the RTCR; 
and what the reduced monitoring frequency is. A copy of the reduced 
monitoring frequency must be provided to the system.
     Any decision to reduce the total coliform monitoring 
frequency for a non-community water system using only ground water and 
serving 1,000 or fewer people to less than once per quarter, as 
provided in Sec.  141.854(e) of the RTCR, and what the reduced 
monitoring frequency is. A copy of the reduced monitoring frequency 
must be provided to the system.
     Any decision to reduce the total coliform monitoring 
frequency for a non-community water system using only ground water and 
serving more than 1,000 persons during any month the system serves 
1,000 or fewer people, as provided in Sec.  141.857(d) of the RTCR. A 
copy of the reduced monitoring frequency must be provided to the 
system.
     Any decision to waive the 24-hour limit for taking a total 
coliform sample for a public water system that uses surface water, or 
ground water under the direct influence of surface water, and that does 
not practice filtration in accordance with part 141, subparts H, P, T, 
and W, and that measures a source water turbidity level exceeding 1 
nephelometric turbidity unit (NTU) near the first service connection.
     Any decision to allow a public water system to forgo E. 
coli testing on a total coliform-positive sample if that system assumes 
that the total coliform-positive sample is E. coli-positive.
    The RTCR also adds the following new recordkeeping requirement:
     States must keep records and supporting information 
regarding completed and approved RTCR assessments, including reports 
from the system that corrective action has been completed, for five 
years.

[[Page 10302]]

2. Reporting
    EPA currently requires at 40 CFR 142.15 that States report to EPA 
information such as violations, variance and exemption status, and 
enforcement actions. The RTCR requires States to develop and maintain a 
list of public water systems that the State is allowing to monitor less 
frequently than once per month for community water systems or less 
frequently than once per quarter for non-community water systems, 
including the compliance date (the date that reduced monitoring was 
approved) of the reduced monitoring requirement for each system.
3. SDWIS
    EPA has begun to plan and develop the next version of SDWIS, SDWIS 
Next Gen, which will provide improved capabilities to update the system 
when there are new rule requirements and that enables more efficient 
data sharing among systems, laboratories, States, and EPA. EPA has 
established a governance structure to allow States to provide input on 
SDWIS Next Gen and begin identifying and prioritizing necessary system 
functions. Developing the portions of the system that are needed for 
implementing RTCR is a high priority. EPA remains committed to 
completing revisions to SDWIS that will facilitate implementation of 
RTCR and to completing them well in advance of the effective date of 
the rule.
4. Key Issues Raised
    Many commenters emphasized the importance of developing revisions 
to SDWIS sufficiently in advance of the effective date of the rule to 
allow for efficient, effective, and consistent implementation, 
tracking, recordkeeping, and reporting. As indicated above, EPA has 
already begun planning and development of SDWIS Next Gen to incorporate 
changes necessary to implement RTCR. EPA plans to complete the 
revisions necessary to implement RTCR well in advance of the RTCR 
effective date. Commenters also noted the advisory committee 
recommendation to develop metrics for evaluating the effectiveness of 
RTCR. Identifying metrics and incorporating them into SDWIS Next Gen 
will be part of the process completed by the governance structure with 
the input of stakeholders.
    Some commenters objected to the requirement for States to maintain 
lists of systems on reduced monitoring and information on decisions on 
sample invalidations and waivers of time limits. EPA notes that these 
requirements also existed under the 1989 TCR and are not new under the 
RTCR. These requirements, and the requirements to maintain other 
information such as regarding assessments and review of seasonal system 
startup procedures, will be considered in the design of SDWIS Next Gen 
and incorporated to the extent possible to help States efficiently 
manage their implementation requirements.
    Commenters also expressed the need for guidance to help States 
implement rule requirements regarding annual site visits for systems on 
annual monitoring, review of system RTCR monitoring frequency during 
sanitary surveys, review of seasonal system startup procedures, and 
identification of qualified assessors for Level 2 assessments. EPA 
plans to work with States to develop the necessary changes in 
implementation guidance well before the effective date of the RTCR.

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

    This section summarizes the economic analysis (EA) for the final 
RTCR. The EA is an assessment of the benefits, both health and non-
health-related, and costs to the regulated community of the final 
regulation, along with those of regulatory alternatives that the Agency 
considered. EPA developed the EA for the RTCR to meet the requirement 
of SDWA section 1412(b)(3)(C) for a Health Risk Reduction and Cost 
Analysis (HRRCA), as well as the requirements of Executive Order 12866, 
Regulatory Planning and Review, and Executive Order 13563, Improving 
Regulation and Regulatory Review, under which EPA must estimate the 
costs and benefits of the rule. The full EA for the final RTCR (RTCR 
EA) (USEPA 2012a) includes additional details and discussion on the 
topics presented throughout this section of the preamble. It is 
available in the docket (Docket ID No. EPA-HQ-OW-2008-0878) and is also 
published on the government's Web site at http://www.regulations.gov.
    SDWA section 1412(b)(3)(C) requires that the HRRCA for a NPDWR take 
into account the following seven elements: (1) Quantifiable and 
nonquantifiable health risk reduction benefits; (2) quantifiable and 
nonquantifiable health risk reduction benefits from reductions in co-
occurring contaminants; (3) quantifiable and nonquantifiable costs that 
are likely to occur solely as a result of compliance; (4) incremental 
costs and benefits of rule options; (5) effects of the contaminant on 
the general population and sensitive subpopulations including infants, 
children, pregnant women, elderly, and individuals with a history of 
serious illness; (6) any increased health risks that may occur as a 
result of compliance, including risks associated with co-occurring 
contaminants; and (7) other relevant factors such as uncertainties in 
the analysis and factors with respect to the degree and nature of risk. 
A summary of these elements is provided in this section of the 
preamble, and a complete discussion can be found in the RTCR EA.
    Both benefit and cost measures are adjusted using social 
discounting. In social discounting, future values of a rule's or 
policy's effects are multiplied by discount factors. The discount 
factors reflect both the amount of time between the present and the 
point at which these events occur and the degree to which current 
consumption is more highly valued than future consumption (USEPA 
2000a). This process allows comparison of cost and benefit streams that 
are variable over a given time period. EPA uses social discount rates 
of both three percent and seven percent to calculate present values 
from the stream of benefits and costs and also to annualize the present 
value estimates. Historically, the use of three percent is based on 
after tax rates of return to consumers on relatively risk-free 
financial instruments, while seven percent is an estimate of average 
economy-wide before-tax rate of return to incremental private 
investment generally. For further information, see USEPA 2000a and OMB 
1996.
    The time frame used for both benefit and cost comparisons in this 
rule is 25 years. This time interval accounts for rule implementation 
activities occurring soon after promulgation (e.g., States adopting the 
criteria of the regulation) and the time for different types of 
compliance actions (e.g., assessments and corrective actions) to be 
realized up through the 25th year following rule promulgation. In the 
RTCR EA, EPA also presents the undiscounted stream of benefits and 
costs over the 25-year time frame in constant 2007 dollars (2007$).
    The benefits described in this section are discussed qualitatively, 
and reductions in occurrence of total coliforms and E. coli and in 
Level 2 assessments are used as indicators of positive benefits. EPA 
was unable to quantify health benefits for the RTCR because there are 
insufficient data reporting the co-occurrence in a single sample of 
fecal indicator E. coli and pathogenic organisms. In addition, the 
available fecal indicator E. coli data from the Six-Year Review 2 
dataset (USEPA 2012a) described in this preamble were limited to 
presence-

[[Page 10303]]

absence data because the 1989 TCR requires only the reporting of 
presence or absence of fecal indicator E. coli using EPA-approved 
standard methods. However, as discussed in chapter 6 of the RTCR EA, 
even though health benefits could not be directly quantified, the 
potential benefits from the RTCR include avoidance of a full range of 
health effects from the consumption of fecally contaminated drinking 
water, including the following: acute and chronic illness, endemic and 
epidemic disease, waterborne disease outbreaks, and death. 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 all of these contaminants.
    The net costs of the rule stem mostly from the new assessment and 
corrective action requirements as well as the revised monitoring 
provisions described earlier in this preamble. The costs discussed in 
this section are presented as annualized present values in constant 
2007$.
    This section of the preamble includes elements as follows: (A) 
Regulatory Options Considered, (B) Major Sources of Data and 
Information Used in Supporting Analyses, (C) Occurrence and Predictive 
Modeling, (D) Baseline Profiles, (E) Anticipated Benefits of the RTCR, 
(F) Anticipated Costs of the RTCR, (G) Potential Impact of the RTCR on 
Households, (H) Incremental Costs and Benefits, (I) Benefits from 
Simultaneous Reduction of Co-occurring Contaminants, (J) Change in Risk 
from Other Contaminants, (K) Effects of Fecal Contamination and/or 
Waterborne Pathogens on the General Population and Sensitive 
Subpopulations, (L) Uncertainties in the Benefit and Cost Estimates for 
the RTCR, (M) Benefit Cost Determination for the RTCR, (N) Comments 
Received in Response to EPA's Requests for Comment, and (O) Other 
Comments Received by EPA.

A. Regulatory Options Considered

    EPA evaluated the following three regulatory options as part of 
this revised rule: (1) The 1989 TCR option, (2) the RTCR option 
(today's final rule), and (3) an Alternative option. EPA discusses the 
three regulatory options briefly in this preamble and in greater detail 
in chapter 3 of the RTCR EA.
    First, the 1989 TCR option reflects EPA's understanding of how the 
1989 TCR is currently being implemented. That is, the 1989 TCR option 
is assumed to include ``status quo'' PWS and State implementation 
practices. Next, the RTCR option is based on the provisions of this 
final rule as described in detail in section III of this preamble, 
Requirements of the Revised Total Coliform Rule. Third, the Alternative 
option parallels the RTCR in most ways but includes variations of some 
of the provisions that were discussed by the advisory committee before 
they reached consensus on the recommendations in their AIP, which 
served as the basis for the proposed and final rules.
    The Alternative option differs from the RTCR option in two ways. 
First, under the Alternative option, at the compliance date all PWSs 
are required to sample monthly for an initial period until they meet 
the eligibility criteria for reduced monitoring. EPA assumes that 
eligibility for reduced monitoring is determined during the next 
sanitary survey following the RTCR compliance date. This more stringent 
approach differs from the RTCR option that allows PWSs to continue to 
monitor at their current frequencies (with an additional annual site 
visit or voluntary Level 2 assessment requirement for PWSs wishing to 
remain on annual monitoring) until they are triggered into an increased 
sampling frequency. Second, under the Alternative option, no PWSs are 
allowed to reduce monitoring to an annual basis. EPA defined the 
Alternative option this way and included it in the RTCR EA to assess 
the relative impacts of a more stringent rule and to better understand 
the balance between costs and public health protection. EPA wishes to 
emphasize that it is not adopting the Alternative Option, but is 
providing cost and benefit information on it as a point of comparison 
with the final rule as promulgated.
    To understand the relative impacts of the options, EPA gathered 
available data and information to develop and provide input into an 
occurrence and predictive model. EPA estimated both baseline conditions 
and changes to these conditions anticipated to occur over time as a 
result of these revised rule options. The analysis is described in more 
detail in the RTCR EA.

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

    This section of the preamble briefly discusses the data sources 
that EPA used in its supporting analyses for the RTCR. For a more 
detailed discussion, see chapter 4 of the RTCR EA.
1. Safe Drinking Water Information System Federal 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 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 violations (both routine 
and repeat and minor and major). It does not include sample results. It 
also contains information to characterize the US inventory of PWSs 
including system name and location, retail population served, source 
water type (ground water (GW), surface water (SW), or ground water 
under the direct influence of surface water (GWUDI)), disinfection 
status, and PWS type (community water system (CWS), transient non-
community water system (TNCWS), and non-transient non-community water 
system (NTNCWS)).
    To create the PWS and population baseline, EPA used the fourth 
quarter of SDWIS/FED 2007 (USEPA 2007b), which was the most current PWS 
inventory data available when EPA began developing the RTCR EA. These 
data represent all current, active PWSs and the population served by 
these systems.
    EPA also used the MCL violation data from SDWIS/FED to validate 
model predictions for systems serving 4,100 or fewer people and to 
predict E. coli (or ``acute,'' under the 1989 TCR) MCL violations (1989 
TCR, RTCR, and Alternative option), total coliform (non-acute or 
monthly) MCL violations (1989 TCR), and Level 1 and Level 2 assessment 
triggers (RTCR and Alternative option) for systems serving more than 
4,100 people.
2. Six-Year Review 2 Data
    Through an Information Collection Request (ICR) (USEPA 2006b), 
States voluntarily submitted electronically available 1989 TCR 
monitoring data \1\ (sample results) that were collected between 
January 1998 and December 2005. EPA requested the 1989 TCR monitoring 
results with the intent of conducting analyses and developing models to 
assess the potential impacts of changes to the 1989 TCR. EPA received 
data from 46 States, Tribes, and territories. A Data Quality Report 
(USEPA 2010c) describes how the 1989 TCR monitoring data were obtained, 
evaluated, and modified where

[[Page 10304]]

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.
---------------------------------------------------------------------------

    \1\ This refers to results of monitoring conducted pursuant to 
the 1989 TCR, not results from the year 1989.
---------------------------------------------------------------------------

    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 RTCR EA, 
EPA used 2005 data exclusively in the analyses supporting the RTCR 
because the 2005 data set was the most complete year of data among the 
Six-Year Review 2 data. The 2005 data was also the most recent data 
available suggesting that it may be the most representative of present 
conditions.
    The Six-Year Review 2 data also informed EPA's assumptions 
regarding the proportions of ground water systems serving 1,000 or 
fewer people that sample monthly, quarterly, or annually.
3. Other Information Sources
    Additional data and information sources included the Economic 
Analysis for the Ground Water Rule (GWR EA) (USEPA 2006a), the 
Technology and Cost Document for the Revised Total Coliform Rule (RTCR 
T&C document) (USEPA 2012b), the US Census data, and the knowledge and 
experience of stakeholders representing industry, States, small 
systems, and the public.
    The GWR EA provided occurrence information on E. coli in the source 
water of ground water PWSs for modeling the triggered monitoring 
component of GWR and informed the assumptions on the distribution of 
corrective actions taken in response to the presence of E. coli in the 
source water. As discussed in section VI.C of this preamble, Occurrence 
and Predictive Modeling, the model developed for this economic analysis 
considers the effect of GWR both before and during implementation of 
the RTCR. The RTCR T&C document included estimates of unit costs for 
the major components of the RTCR that were obtained from the advisory 
committee technical workgroup and vendors, including labor, monitoring, 
assessments, and corrective actions.
    US Census data were used to estimate population per household and 
to characterize sensitive subpopulations. Lastly, knowledge and 
experience from stakeholders helped to inform the assumptions that were 
made for the analysis.
    A more detailed discussion of these data sources and how EPA used 
them are included in the RTCR EA.

C. Occurrence and Predictive Modeling

    EPA used the data to develop an occurrence and predictive model for 
PWSs serving 4,100 or fewer people based primarily on the 2005 Six-Year 
Review 2 data. The model predicts changes in total coliform and E. coli 
occurrence, Level 1 and Level 2 assessments (based on simulated 
monitoring results), corrective actions, and violations over time. EPA 
developed another simpler predictive model for PWSs serving more than 
4,100 people that predicts Level 1 and Level 2 assessments (based on 
2005 violation data from SDWIS/FED), corrective actions, and violations 
over time, but not total coliform and E. coli occurrence. EPA modeled 
systems serving more than 4,100 people separately because the Six-Year 
Review 2 data for larger PWSs were not as robust as the data for the 
smaller systems. In addition, while the RTCR includes new monitoring 
requirements for PWSs serving 4,100 people or fewer, monitoring 
requirements for systems serving greater than 4,100 people remain 
essentially unchanged from the 1989 TCR. This section briefly discusses 
the structures of each of the two models and how they used available 
data, information, and assumptions to make predictions over time 
resulting from the regulatory options.
    Chapter 5 of the RTCR EA includes a more detailed description of 
the occurrence and predictive model used for PWSs serving 4,100 or 
fewer people, and the other simpler predictive model used for PWSs 
serving greater than 4,100 people.
1. Model Used for PWSs Serving 
replacement are occurring at the individual system level, but the 
numbers of violations at the national level have remained relatively 
unchanged. This assumption is based on evaluation of SDWIS/FED 
violation data. Exhibit VI-1 presents the number of PWSs with 
violations from 2001-2007 under the 1989 TCR which shows that national 
violation rates have remained relatively steady over recent years. The 
RTCR will affect this steady state, likely resulting in a reduction of 
the underlying occurrence and associated violations.

                                         Exhibit VI-1--Number of PWSs With Violations by System Type (2001-2007)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                          Year
                           PWS Type                           ------------------------------------------------------------------------------------------
                                                                   2001         2002         2003         2004         2005         2006         2007
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute MCL Violations
--------------------------------------------------------------------------------------------------------------------------------------------------------
CWS..........................................................          143          144          185          171          151          171          171
NTNCWS.......................................................           51           53           70           58           65           68           45
TNCWS........................................................          261          278          322          351          349          361          295
                                                              ------------------------------------------------------------------------------------------

[[Page 10305]]

 
    All......................................................          455          475          577          580          565          600          511
Non-Acute MCL Violations
--------------------------------------------------------------------------------------------------------------------------------------------------------
CWS..........................................................        2,074        2,110        2,204        2,314        2,196        2,095        1,996
NTNCWS.......................................................          601          679          725          750          753          735          655
TNCWS........................................................        2,707        2,934        3,036        3,132        3,039        3,244        3,209
                                                              ------------------------------------------------------------------------------------------
    All......................................................        5,382        5,723        5,965        6,196        5,988        6,074        5,860
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: PWSs counts are of systems that had at least one violation during the year.
Source: SDWIS/FED annual data for period ending 3rd quarter 2001-2007. OH, US territories, Tribal PWS data excluded.

    Before the RTCR goes into effect, GWR implementation begins and is 
also expected to affect the steady state. To estimate the effects that 
GWR implementation is expected to have on present steady state 
conditions, EPA used the occurrence and predictive model to simulate 
five years of implementation of the 1989 TCR with the GWR, which became 
effective in December 2009. EPA assumed these five years to account for 
the approximately two years before the expected promulgation date of 
the final RTCR and an additional three years after that until the RTCR 
effective date. The assumptions made to account for the GWR are 
described in detail in the in the RTCR EA and summarized in Exhibit VI-
2.

      Exhibit VI-2--Summary of Major Assumptions for Simulating GWR
                             Implementation
------------------------------------------------------------------------
             GWR provision                 Modeling approach/assumption
------------------------------------------------------------------------
Triggered Monitoring: Ground water       Current model used same
 systems not providing 4-log treatment    probabilities used in GWR EA
 for viruses that have total coliform-    (USEPA 2006a) to predict
 positive samples under the 1989 TCR      whether source water samples
 are required to take source water        will be E. coli-positive.
 samples and test for a fecal            Ground water systems required
 indicator. If the sample is positive,    to conduct corrective action
 they must take an additional 5 source    due to monitoring results will
 water samples (unless the State          either install disinfection or
 requires corrective action). If any of   implement a nondisinfecting
 these is positive, they must conduct     corrective action as described
 corrective action.                       in the RTCR EA.
                                         Ground water systems installing
                                          disinfection will draw from
                                          the probability distributions
                                          for total coliforms and E.
                                          coli for disinfected systems
                                          for the remainder of analysis.
                                         Ground water systems
                                          implementing a nondisinfecting
                                          corrective action will
                                          experience no positive samples
                                          for the remainder of the year
                                          plus two additional years and
                                          will experience a 75 \1\
                                          percent reduction in
                                          occurrence for five additional
                                          years.
Sanitary Surveys: GWR includes Federal   Model did not explicitly
 sanitary survey requirements for all     simulate sanitary surveys or
 ground water systems, and requires       their results. Rather, it
 States to perform regular                assumed that the new sanitary
 comprehensive sanitary surveys           survey provisions will result
 including eight critical elements.       in 10 percent \2\ reduced
                                          occurrence of total coliforms
                                          universally for entire
                                          analysis.
Compliance Monitoring: Ground water      Model did not explicitly
 systems that provide 4-log treatment     simulate compliance
 for viruses must demonstrate that they   monitoring. Rather, it assumed
 are providing this level of treatment    that the provision will result
 by conducting compliance monitoring.     in 10 percent \3\ reduced
                                          occurrence of total coliforms
                                          for those ground water systems
                                          that are conducting compliance
                                          monitoring once assumed 4-log
                                          treatment for viruses begins.
------------------------------------------------------------------------
1 2 3 Assumption reflects EPA best professional judgment.
Source: RTCR EA (USEPA 2012a) as informed by GWR EA (USEPA 2006a).

    Actual reductions in occurrence from the implementation of GWR 
requirements may differ from what is presented here. However, based on 
assumptions used in this model, the analysis of how the RTCR and 
Alternative option perform relative to each other are not affected.
    In addition to capturing the effect of implementation of GWR 
requirements with the 1989 TCR for a five-year period of analysis, the 
model captures an additional 25 years with the 1989 TCR, the RTCR 
option, and the Alternative option. Along with changes in total 
coliform and E. coli occurrence, the model predicts behavioral changes: 
the number of Level 1 and Level 2 assessments (and associated Level 1 
or Level 2 corrective actions) to be performed, further resulting 
adjustments to occurrence, and changes in sampling regimens as systems 
qualify for reduced monitoring requirements. The assumptions used to 
simulate RTCR implementation are detailed in the RTCR EA and summarized 
in Exhibit VI-3.

[[Page 10306]]

     Exhibit VI-3--Summary of Major Assumptions for Simulating RTCR
                             Implementation
------------------------------------------------------------------------
        RTCR Provision                Modeling Approach/Assumption
------------------------------------------------------------------------
Level 1 Assessment...........  Model simulates sampling and sampling
                                results and determines which PWSs will
                                be triggered to conduct an assessment.
                               Sanitary defects are found in 10 percent
                                \1\ of assessments (represents net
                                increase over the 1989 TCR).
                               All sanitary defects are corrected. Model
                                selects from distribution of potential
                                corrective actions as explained in
                                chapter 7 of the RTCR EA (USEPA 2012a).
                               PWSs implementing a corrective action as
                                a result of a Level 1 assessment
                                experience no positive samples for the
                                remainder of the year plus one
                                additional year and will experience 50
                                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 the 1989 TCR).
                               All sanitary defects are corrected. Model
                                selects from distribution of potential
                                corrective actions as explained in
                                chapter 7 of the RTCR EA (USEPA 2012a).
                               PWSs implementing a corrective action as
                                a result of a Level 2 assessment will
                                experience no positive samples for the
                                remainder of the year plus two
                                additional years and will experience 75
                                percent \4\ reduction in occurrence for
                                five additional years.
------------------------------------------------------------------------
1 3 Assumption based on conversation with State representatives with on-
  the-ground experience.
2 4 Assumption reflects EPA best professional judgment.
Note: EPA recognizes that there is a large uncertainty with the
  assumptions. Sensitivity analyses showed that the fundamental
  conclusions of the economic analysis do not change over a wide range
  of assumptions tested.
Source: RTCR EA (USEPA 2012a)

    EPA made different assumptions for the effectiveness of assessments 
and subsequent corrective actions to account for the differences 
between the two types of assessments. The Level 2 assessment is a more 
comprehensive investigation that may result in finding more substantial 
problems than what may be found during a Level 1 assessment, and for 
that reason the corrective actions that result from a Level 2 
assessment were modeled to result in corrective action measures that 
are generally more expensive and have bigger and longer lasting effects 
than those of the Level 1 assessments. EPA conducted sensitivity 
analyses around the key assumptions summarized in Exhibit VI-2 as 
discussed in section VI.L of this preamble, Uncertainties in the 
Benefit and Cost Estimate for the RTCR.
2. Model Used for PWSs Serving > 4,100 People
    For systems serving more than 4,100 people, EPA estimated violation 
and trigger rates using SDWIS/FED because the Six-Year Review 2 data 
for PWSs serving more than 4,100 people were not as robust as the Six-
Year Review 2 data for systems serving 4,100 or fewer people. EPA did 
not quantify changes in violation or trigger rates for systems serving 
more than 4,100 people among the 1989 TCR, RTCR, and Alternative 
options because of: (1) Limited Six-Year Review 2 data to characterize 
these systems, (2) the essentially unchanged monitoring requirements 
across options for these systems, and (3) the level of effort already 
occurring to implement the 1989 TCR.

D. Baseline Profiles

    The estimate of baseline conditions that EPA developed provides a 
reference point for understanding net impacts of the RTCR.
    Compliance with the GWR began in December 2009, and the expected 
compliance date of the RTCR is approximately six years following 
commencement of the GWR implementation. The majority of PWSs are ground 
water systems and these systems are expected to be affected by the GWR. 
Because GWR implementation prior to the effective date of RTCR is 
expected to cause changes to ground water systems, the baseline 
conditions that EPA developed for ground water systems 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 ground water PWSs that disinfect is expected to 
change during implementation of the GWR before the expected rule 
compliance date of the RTCR. Exhibit VI-4 shows the estimated baseline 
number of the ground water PWSs at the RTCR compliance date.

       Exhibit VI-4--Estimated Baseline Number of Ground Water Systems and Disinfection Status at Compliance Date (3 Years Post RTCR Promulgation)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of ground water PWSs (post-GWR)
                                             -----------------------------------------------------------------------------------------------------------
                  PWS Size                                    CWS                               NTNCWS                               TNCWS
                                             -----------------------------------------------------------------------------------------------------------
                                                Disinfecting    Non-disinfecting    Disinfecting    Non-disinfecting    Disinfecting    Non-disinfecting
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 M........................................                 3  ................  ................  ................  ................  ................

[[Page 10307]]

 
    Total...................................            27,610            12,691             7,191            10,850            20,189            61,937
    Combined Total..........................  ................            40,301  ................            18,041  ................            82,126
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: RTCR Occurrence and Predictive Model Output as detailed in the RTCR EA (USEPA 2012a)

    EPA estimated the numbers of ground water PWSs that monitor 
monthly, quarterly, and annually under the 1989 TCR based on an 
analysis of the Six-Year Review 2 data and individual State statutes 
conducted by EPA and the advisory committee Technical Work Group (TWG). 
Of the ground water 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 a continuation of the 1989 TCR. For the RTCR option, 
EPA assumed that only the percentage of systems that received an annual 
site visit under the 1989 TCR would continue on annual monitoring under 
the RTCR; the percentage of systems that would therefore no longer 
qualify for annual monitoring under the RTCR were assumed to revert to 
baseline quarterly monitoring. Under the Alternative option, all PWSs, 
regardless of size or type, start at monthly monitoring at the rule 
effective date.
    The following two tables provide an overview of summary statistics 
relating to baseline water quality. Exhibit VI-5 shows the percentage 
of total coliform- and E. coli-positive samples based on PWS type and 
size. The percentages of samples that are total coliform-positive are 
generally higher in ground water systems than in surface water systems; 
in smaller systems than in larger systems; and in NCWSs than in CWSs.

                                    Exhibit VI-5--Total Coliform and E. coli Percent Positive by System Size and Type
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Total
                                                           Population       coliform      Total        Total        E. coli     E. coli (+   E. coli (%
             PWS Type                  Source water          served        (  coliform (+  coliform (%   (     samples)     positive)
                                                                            samples)     samples)    positive)   samples) \1\                    \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
CWS..............................  Ground Water (GW)..             100,000       64,965          289         0.44            34            1          0.00
                                   ...................          Total GW      722,298        8,271         1.15         4,562          199          0.03
                                   Surface Water (SW).             100,000      112,143          235         0.21            99            2          0.00
                                   ...................          Total SW      495,384        1,643         0.33         1,130           88          0.02
                                   GW & SW............         Total CWS    1,217,682        9,914         0.81         5,692          287          0.02
TNCWS............................  GW.................             1,000        7,062          143         2.02            85            2          0.03
                                   ...................          Total GW      230,635       10,680         4.63         7,991          421          0.18
                                   SW.................             1,000          988            6         0.61            37  ...........          0.00
                                   ...................          Total SW       11,088          250         2.25           266           30          0.27
                                   GW & SW............       Total TNCWS      241,723       10,930         4.52         8,257          451          0.19
NTNCWS...........................  GW.................             1,000       13,138          177         1.35           103            5          0.04
                                   ...................          Total GW      102,258        2,712         2.65         1,895           60          0.06
                                   SW.................             1,000        1,316            1         0.08             1  ...........          0.00
                                   ...................          Total SW        6,220           48         0.77            45            6          0.10
                                   GW & SW............      Total NTNCWS      108,478        2,760         2.54         1,940           66          0.06
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Number of samples that were specifically tested for E. coli. The denominator of the E. coli percent positive calculation includes this number plus
  the number of total coliform negative samples (number of total coliform samples--number of total coliform-positive samples).
\2\ Percent of E. coli-positive was calculated as (number of E. coli-positive samples)/(number of E. coli samples taken) x 100.
Source: Derived using Six-Year Review 2 Data, which was filtered by including a State only if the State's PWSs as a group had submitted at least 50
  percent of the expected sample-months of usable data. The Total Coliform Compliance Monitoring Data Quality and Completion Report (USEPA 2010b)
  includes a detailed description of this data cleaning process.

[[Page 10308]]

    Exhibit VI-6 presents the number of acute and non-acute violations 
reported by PWSs. The number of violations is also an indicator of 
baseline water quality prior to implementation of the RTCR. As 
discussed in detail chapter 5 of the RTCR EA, EPA used these data to 
estimate the numbers of MCL violations and triggers for PWSs serving 
more than 4,100 people for the three options. Under the 1989 TCR, 
larger systems incur a relatively small number of violations annually, 
while smaller systems incur the majority.

                                     Exhibit VI-6--Baseline Number of TCR Violations by System Size and Type (2005)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Ground water PWSs                      Surface Water PWSs
                                                              ------------------------------------------------------------------------------   All PWSs
                                                                Non-Acute      Acute        Total      Non-Acute      Acute        Total        Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
CWSs
--------------------------------------------------------------------------------------------------------------------------------------------------------
 1M.........................................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........
    Total CWSs...............................................        2,497          126        2,623          299           32          331        2,954
--------------------------------------------------------------------------------------------------------------------------------------------------------
NTNCWSs
--------------------------------------------------------------------------------------------------------------------------------------------------------
 1M.........................................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........
                                                              ------------------------------------------------------------------------------------------
    Total NTNCWSs............................................          985           66        1,051           14            2           16        1,067
--------------------------------------------------------------------------------------------------------------------------------------------------------
TNCWSs
--------------------------------------------------------------------------------------------------------------------------------------------------------
 1M.........................................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........
                                                              ------------------------------------------------------------------------------------------
    Total TNCWSs.............................................        3,694          367        4,061           36            6           42        4,103
    Grand Total..............................................        7,176          559        7,735          349           40          389        8,124
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: The RTCR EA uses violations data for PWSs serving greater than 4,100 people to estimate triggers for these systems. Data for other system sizes is
  provided for reference.
Source: Acute/Non-Acute Violations from SDWIS/FED annual data for period ending 3rd quarter 2001-2007 (only 2005 data is presented in this exhibit). OH,
  U.S. territories, Tribal PWS data excluded. See the RTCR EA (USEPA 2012a) for additional details.

E. Anticipated Benefits of the RTCR

    In promulgating the RTCR, EPA expects to further reduce the risk of 
contamination of public drinking water supplies from the current 
baseline risk under the 1989 TCR. The options considered during 
development of this rule and analyzed as part of the RTCR EA are 
designed to achieve this reduction while maintaining public health 
protection in a cost-effective manner.
    This section examines the benefits in terms of trade-offs among 
compliance with the 1989 TCR option, the RTCR option, and the 
Alternative option. Because there are insufficient data reporting the 
co-occurrence in a single sample of fecal indicator E. coli and 
pathogenic organisms and because the available fecal indicator E. coli 
data from the Six-Year Review 2 dataset were limited to presence-
absence data, EPA was unable to quantify health benefits for the RTCR. 
EPA used several methods to qualitatively evaluate the benefits of the 
RTCR options. The qualitative evaluation uses both the judgment of EPA 
as informed by the TCRDSAC deliberations as well as quantitative 
estimates of changes in total coliform occurrence and counts of systems 
implementing corrective actions. The evaluation characterizes, in 
relative terms, the reduction in risk for each regulatory scenario as 
compared to baseline conditions.
    Since E. coli is an indicator of fecal contamination, EPA assumed 
that a decrease in E. coli occurrence in the

[[Page 10309]]

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 RTCR. 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 all of these contaminants.
    As presented in Exhibit VI-5, the percentages of samples that are 
positive for total coliforms and E. coli are generally higher for PWSs 
serving 4,100 or fewer people than those serving more than 4,100 
people. PWSs with higher total coliform and E. coli occurrence are more 
likely to be triggered into assessments and corrective action. As 
discussed previously, the assessments and corrective action lead to a 
decrease in total coliform and E. coli occurrence. Because the PWSs 
serving 4,100 or fewer people have a higher initial E. coli occurrence 
and are likely triggered into more assessments and corrective actions 
than larger PWSs, the increase in benefits for these small systems are 
likely more evident as compared to the larger systems. In particular, 
model results suggest that customers of small ground water TNCWSs 
serving 100 or fewer people, which constitute approximately 40 percent 
of PWSs, experience the most improvement in water quality under the 
RTCR. That is, the occurrence of E. coli is predicted to decrease more 
for these systems than for other systems types.
1. Relative Risk Analysis
    When revising an existing drinking water regulation, one of the 
main concerns is to ensure that backsliding on water quality and public 
health protection does not occur. SDWA requires that EPA maintain or 
improve public health protection for any rule revision. The RTCR is 
more stringent than the 1989 TCR with regard to protecting public 
health. The basis for this perspective is provided in this subsection 
and the following subsections (sections VI.E.2, Changes in violation 
rates and corrective actions, and VI.E.3, Nonquantifiable benefits) of 
this preamble.
    Risk reduction for the RTCR is characterized by the activities 
performed that are presumed to reduce risk of exposing the public to 
contaminated water. These activities are considered under each rule 
component presented in Exhibit VI-8.
    More frequent monitoring has the potential to decrease the risk of 
contamination in PWSs based on an enhanced ability to diagnose and 
mitigate system issues in a more timely fashion. Conversely, less 
frequent monitoring has the potential to increase risk. Real-time 
continuous sampling would mitigate the most risk possible based on 
sampling schedule; however, it would cost prohibitively more than the 
periodic sampling practiced under the 1989 TCR and included in the RTCR 
and the Alternative option. EPA's objective in proposing the sampling 
schedules included in the RTCR and Alternative option was to find an 
appropriate balance between the factors of risk mitigation and cost 
management.
    Under the RTCR and Alternative option, the reduction in the number 
of required repeat samples and additional routine samples for some PWSs 
has the potential to contribute to increased risk for PWS customers 
(see also section III.C, Monitoring, and III.D, Repeat Samples, of this 
preamble for discussions on the additional routine sample and repeat 
sample provisions respectively). However, this potential increase in 
risk is expected to be more than offset by potential decreases in risk 
from increased routine monitoring (see section III.C of this preamble, 
Monitoring) and the addition of the assessments and corrective action 
provisions (see section III.E of this preamble, Coliform Treatment 
Technique) that find and fix problems indicated by monitoring. Exhibit 
VI-7 illustrates the predicted reduced frequency at which total 
coliforms occur subsequent to the implementation of the RTCR and 
Alternative option. As discussed previously, the RTCR uses total 
coliform occurrence as an indicator of potential pathways for possible 
contamination to enter the distribution system (see section III.B of 
this preamble, Rule Construct: MCLG and MCL for E. coli and Coliform 
Treatment Technique). Exhibit VI-7 illustrates the combined effects on 
total coliform occurrence resulting from changes in monitoring and the 
effects of assessments and corrective actions for the different rule 
options for very small systems. The relative trends indicated in 
Exhibit VI-7 for TNCWSs also pertain to other PWS categories as 
illustrated in chapter 5 of the RTCR EA. EPA chose to include the 
characterization for TNCWSs because they represent the system category 
of largest influence on the national impacts.

[[Page 10310]]

[GRAPHIC] [TIFF OMITTED] TR13FE13.000

    The effect that the elimination of public notification requirements 
for monthly/non-acute MCL violations has on risk is difficult to 
predict. Some factors, such as reduction in available public 
information and possible PWS complacency, lead to a potential increase 
in risk and other factors, such as less confusion (PN more in line with 
potential health risks) and PWSs resources used more efficiently, lead 
to a potential decrease, as discussed in Exhibit VI-8. This change to 
PN is addressing a key concern expressed by various stakeholders in the 
advisory committee and during the Six-Year Review 1 comment 
solicitation process. By eliminating the requirement and replacing it 
with assessment and corrective action requirements, the Agency expects 
less public confusion, more effective use of resources, increased 
transparency, and increased public health protection.
    Other rule components are expected to have a negligible effect on 
risk. However, the overall effect of the RTCR is expected to be a 
further reduction in risk from the current baseline risk under the 1989 
TCR. Chapter 6 of the RTCR EA presents a detailed discussion of the 
potential influence on health risk for each rule component.

                         Exhibit VI-8--Potential Changes in Risk Under the RTCR and Alternative Option Relative to the 1989 TCR
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Factors leading to a potential          Factors leading to a potential         Overall predicted change in risk
                                             increase in risk                        decrease in risk            ---------------------------------------
         RTCR Component          --------------------------------------------------------------------------------
                                         RTCR             Alternative            RTCR             Alternative            RTCR             Alternative
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implementation Activities.......  None..............  None..............  None..............  None..............  No change.........  No change.

[[Page 10311]]

 
Routine Monitoring (Including     None..............  None..............  Increased           PWSs all monitor    Decrease..........  Decrease.
 Reduced Monitoring).                                                      stringency in       monthly in the
                                                                           requirements to     first few years
                                                                           qualify for         of implementation
                                                                           reduced             of the RTCR,
                                                                           monitoring along    which is an
                                                                           with requirement    increase in
                                                                           to return to        sampling
                                                                           baseline            frequency for
                                                                           monitoring upon     systems that
                                                                           loss of these       monitor quarterly
                                                                           criteria is         or annually under
                                                                           expected to         the 1989 TCR.
                                                                           result in           After the first
                                                                           decreased risk      few years,
                                                                           (That is, fewer     systems may
                                                                           PWSs will qualify   reduce to
                                                                           and therefore       quarterly, but
                                                                           PWSs will on        none may reduce
                                                                           average monitor     to annual
                                                                           more frequently     monitoring,
                                                                           than under the      creating a
                                                                           baseline for        decrease in risk
                                                                           reduced             for systems on
                                                                           monitoring).        annual monitoring
                                                                                               under the 1989
                                                                                               TCR.
Repeat Monitoring...............  Required repeat     Same as RTCR        None..............  None..............  Increase..........  Increase.
                                   samples reduced     option.
                                   from 4 to 3 for
                                   systems serving
                                   Non- Reduction in        Same as RTCR        Less confusion (PN  Same as RTCR        Unknown...........  Unknown.
 Acute MCL Violations.             available public    option.             more in line with   option.
                                   information.                            potential health
                                  Possible PWS                             risks).
                                   complacency.                           PWSs resources
                                                                           used more
                                                                           efficiently.

[[Page 10312]]

 
Public Notification--Monitoring   None..............  None..............  Increased           Same as RTCR        Decrease..........  Decrease.
 and Reporting Violations.                                                 stringency of PNs   option.
                                                                           motivates PWSs to
                                                                           conduct required
                                                                           sampling.
Overall.........................  ..................  ..................  ..................  ..................  Decrease..........  Decrease.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: Detailed discussion of the rationale for determinations of potential risk for each rule component is presented in chapter 6 (section 6.2) of the
  RTCR EA (USEPA 2012a). Implementation activities consist of administrative activities by PWSs and States to implement the rule.
Assessment of potential changes in risk for monitoring components is an overall assessment. Potential changes (or static state) of risk for particular
  system sizes and types differ according to individual regulatory requirements and are discussed in section 6.2 of the RTCR EA. Chapter 3 of the RTCR
  EA provides a detailed description of the regulatory components for all three regulatory scenarios, and this preamble provides additional discussion
  of the TCRDSAC process and the rationale underlying the structure of the regulatory options considered.

2. Changes in Violation Rates and Corrective Actions
    The quantified portion of the benefits analysis focuses on several 
measures that contribute to the changes in risk expected under the 
RTCR. Specifically, EPA modeled the predicted outcomes based on each 
regulatory option considered--baseline (1989 TCR), the RTCR (final 
rule), and the Alternative option--in the form of estimates of non-
acute violations for the 1989 TCR and assessment triggers for the RTCR 
and Alternative option; E. coli violations; and the number of 
corrective actions implemented under each option. This section of the 
preamble includes six graphs (Exhibit VI-9 through Exhibit VI-14) that 
help to illustrate these endpoints.
    Evaluation of each of these endpoints informed EPA's understanding 
of potential changes to the underlying quality of drinking water. In 
particular, the number of corrective actions performed has a strong 
relationship to potential improvements in water quality and public 
health. For a given rate of total coliform and E. coli occurrence, an 
increase in the number of corrective actions implemented leads to 
improved water quality. However, a reduction in sampling likely leads 
to a reduction in total coliform and E. coli positives being found, 
which in turn likely leads to a reduction in assessments and corrective 
actions being implemented. The number of total coliform and E. coli 
positives that are prevented, missed, or found under each regulatory 
option considered in comparison to those predicted under the 1989 TCR 
results in estimates of annual non-acute and acute violations (1989 
TCR) and assessment triggers (RTCR and Alternative option). Section 6.4 
of the RTCR EA presents a step-wise sensitivity analysis of the 
competing effects of additional protective activity (e.g., assessments 
and corrective actions) and decreased additional routine and repeat 
sampling of the RTCR compared to the 1989 TCR. The conclusions of this 
sensitivity analysis showed that for all categories of systems, more 
total coliform and E. coli positives are expected to be prevented than 
missed under the RTCR relative to the 1989 TCR.
    For each of the graphs presented in Exhibit VI-9 through Exhibit 
VI-14, there are two main model drivers that affect the endpoints 
depicted: the total number of samples taken over time (including 
routine, additional routine, and repeat samples) and the effect of 
corrective actions taken. When looking at the comparisons between the 
1989 TCR with the RTCR across all PWSs, the overall effect of the total 
numbers of samples taken is negligible because the total number of 
samples predicted to be taken throughout the period of analysis is 
almost the same (approximately 82M samples) under both the 1989 TCR and 
RTCR. For the Alternative option, the analysis predicts that 
approximately 88M total samples are taken over the period of analysis. 
Exhibit VI-18 of this preamble presents estimated total numbers of 
samples taken over the 25-year period of analysis. Based on the 
relationships of total samples taken among the 1989 TCR, RTCR, and 
Alternative option, the best way to interpret the graphs presented in 
this section is in a step-wise manner.
    The first comparison that should be made is between the 1989 TCR 
option and RTCR. Because similar total numbers of samples are taken 
under the 1989 TCR and RTCR, the major effect seen in the graphs can be 
isolated to the effects that implementation of corrective actions has 
on underlying occurrence and how that occurrence influences the 
endpoint in question (assessments, E. coli MCL violations, and 
corrective actions). In each graph, this is depicted by a marked 
reduction in the endpoint under the RTCR compared to the 1989 TCR 
option and is a reflection of overall better water quality. The second 
comparison can then be made of the Alternative option against the RTCR. 
In each graph, the predicted results (assessments, E. coli MCL 
violations, and corrective actions) for the Alternative option are 
above those for the RTCR and represent an additional benefit over the 
RTCR. This additional benefit is primarily a function of the additional 
diagnostic abilities gained through increased monitoring under the 
Alternative option, and is especially prominent in the early years of 
the analysis, since all systems are initially required to monitor at 
least monthly.
    More detailed descriptions of each endpoint considered in terms of 
the evaluation process described previously are provided in this 
section as they apply to the individual graphs in Exhibit VI-9 through 
VI-14. Each of the graphs shown in this section is presented first in 
nondiscounted terms, and then based on a discount rate of three percent 
to reflect the reduced valuation of potential benefits over time, 
consistent with the presentation of costs in the section that follows. 
Graphs of benefits discounted using seven percent discounted rates are 
presented in Appendix B of the RTCR EA.
    Exhibit VI-9 shows the effect (on average across all PWSs) of the 
RTCR and the Alternative option on the annual number of non-acute 
violations (1989 TCR) and assessment triggers (RTCR and Alternative 
option) over time. The estimated reduction of annual assessment 
triggers (from the 1989 TCR

[[Page 10313]]

estimates of non-acute violations) by approximately 1,000 events under 
the RTCR is a reflection of the improved water quality expected under 
the RTCR. A similar but smaller reduction in non-acute violations 
(Level 1 triggers) from the 1989 TCR is seen under the Alternative 
option. The larger initial estimate of assessment triggers followed by 
a higher steady state number for the Alternative option than seen under 
the RTCR 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 RTCR.
    Exhibit VI-10 shows the effect (on average across all PWSs) of the 
RTCR and the Alternative option with respect to E. coli violations 
found over the 25-year period of analysis in comparison to the 1989 
TCR. The overall reduction in annual E. coli violations under the RTCR 
of more than 100 events is a measure that should correlate more closely 
with expected benefits (that is, reductions in adverse health outcomes) 
than non-acute events (as presented in Exhibit VI-9) because E. coli 
violations are a direct result of measurement of fecal contamination in 
water. A similar but smaller reduction in E. coli violations is seen 
under the Alternative option after steady state is achieved. This is 
the result of two off-setting effects. The ``true'' number of steady 
state violations under the Alternative option is lower because there is 
a greater likelihood that violations will be found and fixed. However, 
the additional monitoring leads to a higher percentage of violations 
being detected. This second effect outweighs the first, so that the 
total number of detected violations in the steady state is higher than 
for the RTCR, even though the underlying ``true'' number of violations 
is lower. This lower number of ``true'' violations means that the 
Alternative option is more protective of public health, even though 
more violations are detected.
    Exhibit VI-11 presents estimates over the 25-year period of 
analysis of the increase in corrective actions relative to the 1989 TCR 
(on average across all PWSs) attributable to the RTCR and Alternative 
option. Performance of these additional corrective actions is expected 
to result in the most direct benefits under the RTCR. Because only the 
incremental numbers of corrective actions estimated under the RTCR and 
Alternative option were modeled, the reference point for comparison to 
the 1989 TCR is the base (zero) line in the graph. The RTCR EA assumes 
that corrective actions are already being performed under the 1989 TCR. 
Baseline corrective actions are taken into account by assuming only a 
modest incremental increase of 10 percent in implementation of 
effective corrective actions under both the RTCR and Alternative 
option.
    Exhibit VI-11 indicates that more corrective actions are 
implemented under the Alternative option than under the RTCR. This is 
driven, again, by the increased diagnostic power of more sampling and 
reflects additional potential benefits beyond those gained under the 
RTCR.
    Taken together, Exhibit VI-9 through Exhibit VI-11 indicate that 
the modeled endpoints for the RTCR and the Alternative option predict 
positive benefits in comparison to the 1989 TCR; in particular, the 
Alternative option captures more benefits than the RTCR. Similar to the 
patterns seen in Exhibits VI-9 through VI-11, for each of the 
discounted endpoints presented over time in Exhibits VI-12 though VI-
14, the graphs show that (on average across all PWSs) the Alternative 
option provides more benefit than the RTCR, and both provide more 
benefit than the 1989 TCR. These outcomes are consistent with the 
qualitative assessment of the benefits summarized in this section of 
this preamble.
    The major difference between the RTCR and the Alternative option is 
the increased monitoring that is required under the Alternative option. 
The increased diagnostic ability of the extra samples taken under the 
Alternative option is seen in the large difference in the endpoint 
counts through the first several years in Exhibit VI-9 through Exhibit 
VI-14. Absent this effect, the Alternative option essentially mirrors 
the RTCR in the exhibits. Even though the predicted results 
(assessments, E. coli MCL violations, and corrective actions) under the 
Alternative option are greater than the 1989 TCR at first, the trend is 
due to initially finding more problems through monitoring. The 
increased monitoring during the first several years under the 
Alternative option results in a frontloading of benefits at the 
beginning of the implementation period. The benefits, however, tend to 
even out over time between the RTCR and Alternative option as eligible 
systems qualify for less intense (quarterly) monitoring under the 
Alternative option. However, the Alternative option leads to a greater 
number of assessments, E. coli MCL violations, and corrective actions 
than the RTCR because all PWSs are required to sample no less than 
quarterly under the Alternative option while under the RTCR 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.

BILLING CODE P

[[Page 10314]]

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[[Page 10315]]

[GRAPHIC] [TIFF OMITTED] TR13FE13.002

[[Page 10316]]

[GRAPHIC] [TIFF OMITTED] TR13FE13.003

[[Page 10317]]

[GRAPHIC] [TIFF OMITTED] TR13FE13.004

[[Page 10318]]

[GRAPHIC] [TIFF OMITTED] TR13FE13.005

[[Page 10319]]

[GRAPHIC] [TIFF OMITTED] TR13FE13.006

BILLING CODE C
3. Nonquantifiable Benefits
    a. Potential decreased incidence of endemic illness from fecal 
contamination, waterborne pathogens, and associated outbreaks. As 
discussed in section VI.E of this preamble, Anticipated Benefits of the 
RTCR, and chapter 2 of the RTCR EA, benefits from the RTCR may include 
avoidance of a full range of health effects from the consumption of 
fecally contaminated drinking water, including the following: acute and 
chronic illness, endemic and epidemic disease, waterborne disease 
outbreaks, and death. EPA recognizes that the EPA-approved standard 
methods available for E. coli do not typically identify the presence of 
the pathogenic E. coli strains, such as E. coli O157:H7. Thus, E. coli 
occurrence, as used in this EA, serves as an indication of fecal 
contamination but not necessarily pathogenic contamination. See also 
discussion in section II.D of this preamble, Public Health Concerns 
Addressed by the Revised Total Coliform Rule.
    EPA was unable to quantify the cases of morbidity or mortality 
avoided because there are insufficient data reporting the co-occurrence 
of fecal indicator E. coli and pathogenic organisms in a single water 
sample, and because the available fecal indicator E. coli data from the 
Six-Year Review 2 dataset were limited to presence-absence data. 
Instead, EPA estimated changes in total coliform and fecal indicator E. 
coli occurrence and changes in number of corrective actions 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

[[Page 10320]]

contamination can contain waterborne pathogens including bacteria, 
viruses, and parasitic protozoa, in general, a reduction in fecal 
contamination should reduce the potential risk from all of these 
contaminants and the associated primary and secondary endemic disease 
burden, both acute and chronic.
    b. Other nonquantifiable benefits. This section describes other 
nonquantified benefits, which include those associated with increased 
knowledge regarding system operation, accelerated maintenance and 
repair, avoided costs of outbreaks, and reductions in averting 
behavior.
    By requiring PWSs to conduct assessments that meet minimum elements 
focused on identifying sanitary defects in response to triggers for 
total coliform- or E. coli-positive samples, the RTCR increases the 
likelihood that PWS operators, in particular those of systems triggered 
to conduct assessments and corrective action, will develop further 
understanding of system operations and improve and practice preventive 
maintenance compared to the 1989 TCR, which does not require PWSs to 
perform assessments and corrective action.
    Another non-quantified benefit is that systems may choose 
corrective actions that also address other drinking water contaminants. 
For example, correcting for a pathway of potential contamination into 
the distribution system can possibly also mitigate a variety of other 
potential contaminants. Due to the lack of data available on the effect 
of corrective action on contamination entering through distribution 
system pathways, EPA has not quantified such potential benefits.
    Some systems may see additional nonquantified benefits associated 
with the acceleration of their capital replacement fund investments in 
response to early identification of impending problems with large 
capital components. Although such capital investment will eventually 
occur in the absence of RTCR requirements, earlier investment may 
ensure that problems are addressed in a preventive manner and may 
preclude some decrease in protection that might have occurred 
otherwise. At the very least, the increased operator awareness is 
expected to reduce the occurrence of unplanned capital expenditures in 
any given year. However, because of the difficulty of projecting when 
capital replacements would occur, EPA has not costed this acceleration 
of capital replacement, so there would also be a nonquantified cost of 
making such investments sooner.
    Another major non-health benefit is the avoided costs associated 
with outbreak response. Outbreaks can be very costly for both the PWS 
and the community in which they occur. Avoided outbreak response costs 
include such costs as issuing public health warnings, boiling drinking 
water and providing alternative supplies, remediation and repair, and 
testing and laboratory costs. Reduced total coliform occurrence 
resulting from the RTCR may also lead to a reduction of costs 
associated with boil-water orders, which some States require following 
non-acute violations under the 1989 TCR. Taken together, these expenses 
can be quite significant. For example, an analysis of the economic 
impacts of a waterborne disease outbreak in Walkerton, Ontario 
(population 5,000) estimated the economic impact (excluding estimates 
of the value of a statistical life for seven deaths and intangible 
costs for illness-related suffering) to be over $45.9M in 2007 Canadian 
dollars (approximately $42.8M 2007 US dollars) (Livernois 2002). Note 
that some of these costs were incurred by individuals and businesses in 
neighboring communities. The author of the study suggested that this 
was a conservative estimate.
    In addition, the RTCR may also reduce uncertainty regarding 
drinking water safety, which may lead to reduced costs for averting 
behaviors. Averting behaviors include the use of bottled water and 
point-of-use devices. This benefit also includes the reductions in time 
spent on averting behavior such as the time spent obtaining alternative 
water supplies.

F. Anticipated Costs of the RTCR

    To understand the net impacts of the RTCR on public water systems 
and States in terms of costs, EPA first used available data, 
information, and best professional judgment to characterize how PWSs 
and States are currently implementing the 1989 TCR. Then, EPA 
considered the net change in costs that results from implementing the 
RTCR or Alternative option as compared to the costs of continuing with 
the 1989 TCR. The objective was to present the net change in costs 
resulting from revisions to the 1989 TCR rather than absolute total 
costs of implementing the 1989 TCR as revised by the RTCR. More 
detailed information on cost estimates is provided in the sections that 
follow and a complete discussion can be found in chapter 7 of the RTCR 
EA. A detailed discussion of the RTCR requirements is located in 
section III of this preamble, Requirements of the Revised Total 
Coliform Rule.
1. Total Annualized Present Value Costs
    To compare cost of compliance activities for the three regulatory 
scenarios, the year or years in which all costs are expended are 
determined and the costs are then calculated as a net present value. 
For the purposes of this EA, one-time and yearly costs were projected 
over a 25-year time period to allow comparison with other drinking 
water regulations using the same analysis period. For this analysis, 
the net present values of costs in 2007 dollars are calculated using 
discount rates of three percent and seven percent. These present value 
costs are then annualized over the 25-year period using the two 
discount rates.
    Exhibit VI-15 summarizes the comparison of total and net change in 
annualized present value costs of the RTCR and Alternative option 
relative to the 1989 TCR baseline. A continuation of the 1989 TCR will 
result in no net change in costs. In calculating the 1989 TCR baseline, 
not all activities that PWSs and States are performing under the 1989 
TCR were quantified (see Exhibit VI-16 of this preamble). Some of these 
activities are not required under the 1989 TCR but PWSs are performing 
them nonetheless (e.g., corrective actions); or these activities are 
required under the 1989 TCR and PWSs and States will continue to 
perform them under either the RTCR or Alternative option (e.g., 
revising sample siting plans). Instead of determining the absolute 
costs of performing these activities, EPA estimated the net increase in 
costs from these activities as a result of implementing either the RTCR 
or the Alternative option. The net change in mean annualized national 
costs of the RTCR option relative to the 1989 TCR is estimated to be 
approximately $14M using either a three percent or seven percent 
discount rate. The net change in mean annualized national costs for the 
Alternative option relative to the 1989 TCR are estimated to be 
approximately $30M using a three percent discount rate and $32M using a 
seven percent discount rate.
    Under the RTCR, public water systems are estimated to incur greater 
than 90 percent of the RTCR's net annualized costs. States are expected 
to incur the remaining costs.

[[Page 10321]]

                                   Exhibit VI-15--Comparison of Total and Net Change From 1989 TCR in Annualized Costs
                                                                   [$Millions, 2007$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         3% discount rate                                7% discount rate
                                                         -----------------------------------------------------------------------------------------------
                                                               PWSs            State           Total           PWSs            State           Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
1989 TCR: Baseline \1\..................................             185             0.9             186             178             0.9             179
RTCR: Baseline + Incremental \2\........................             199             1.1             200             192             1.3             193
RTCR: Net Change........................................              14             0.1              14              14             0.4              14
RTCR: Percent Change....................................              8%             16%              8%              8%             48%              8%
Alternative option: Baseline + Incremental \2\..........             214             1.2             216             209             1.5             210
Alternative option: Net Change..........................              29             0.3              30              31             0.6              32
Alternative option: Percent Change......................             16%             34%             16%             17%             69%             18%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Detail may not add due to independent rounding.
Source: RTCR EA (USEPA 2012a).
\1\ Does not quantify all 1989 TCR components.
\2\ For components not quantified for the 1989 TCR, only the net increase in the costs of these components is considered for the RTCR and Alternative
  option (e.g., corrective action costs).

    Exhibit VI-16 presents the comparison of total and net change in 
annualized costs for PWSs and States by rule component. The table shows 
that corrective action costs are the most significant contributors to 
the net increase in costs for PWSs under the RTCR. For the Alternative 
option, routine monitoring costs are the most significant contributor 
to the net increase in costs for PWSs. For States, revision of sample 
siting plans contributes most to the cost increase under the RTCR and 
Alternative option. For both PWSs and States, a net decrease in costs 
associated with PN requirements helps to offset the total net cost 
increase.

                                 Exhibit VI-16--Comparison of Total and Net Change in Annualized Costs by Rule Component
                                                                   [$Millions, 2007$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         3% discount rate                                7% discount rate
                                                         -----------------------------------------------------------------------------------------------
                                                               PWSs            State           Total           PWSs            State           Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                   Rule Implementation and Annual Administration
--------------------------------------------------------------------------------------------------------------------------------------------------------
1989 TCR--Total.........................................  ..............  ..............  ..............  ..............  ..............  ..............
RTCR--Total.............................................            2.77            0.18            2.95            4.00            0.26            4.26
RTCR--Net Change........................................            2.77            0.18            2.95            4.00            0.26            4.26
Alternative Option--Total...............................            2.77            0.18            2.95            4.00            0.26            4.26
Alternative Option--Net Change..........................            2.77            0.18            2.95            4.00            0.26            4.26
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Sample Siting Plan Revision
--------------------------------------------------------------------------------------------------------------------------------------------------------
1989 TCR--Total.........................................  ..............  ..............  ..............  ..............  ..............  ..............
RTCR--Total.............................................            0.59            0.42            1.01            0.84            0.59            1.42
RTCR--Net Change........................................            0.59            0.42            1.01            0.84            0.59            1.42
Alternative Option--Total...............................            0.59            0.42            1.01            0.84            0.59            1.42
Alternative Option--Net Change..........................            0.59            0.42            1.01            0.84            0.59            1.42
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                Routine Monitoring
--------------------------------------------------------------------------------------------------------------------------------------------------------
1989 TCR--Total.........................................          170.59  ..............          170.59          163.94  ..............          163.94
RTCR--Total.............................................          174.71  ..............          174.71          167.74  ..............          167.74
RTCR--Net Change........................................            4.12  ..............            4.12            3.80  ..............            3.80
Alternative Option--Total...............................          187.50  ..............          187.50          182.48  ..............          182.48
Alternative Option--Net Change..........................           16.91  ..............           16.91           18.54  ..............           18.54
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Additional Routine Monitoring
--------------------------------------------------------------------------------------------------------------------------------------------------------
1989 TCR--Total.........................................            3.87  ..............            3.87            3.72  ..............            3.72
RTCR--Total.............................................            1.12  ..............            1.12            1.09  ..............            1.09
RTCR--Net Change........................................          (2.75)  ..............          (2.75)          (2.63)  ..............          (2.63)
Alternative Option--Total...............................            0.78  ..............            0.78            0.66  ..............            0.66
Alternative Option--Net Change..........................          (3.10)  ..............          (3.10)          (3.06)  ..............          (3.06)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                 Repeat Monitoring
--------------------------------------------------------------------------------------------------------------------------------------------------------
1989 TCR--Total.........................................            5.11  ..............            5.11            4.92  ..............            4.92
RTCR--Total.............................................            4.88  ..............            4.88            4.70  ..............            4.70
RTCR--Net Change........................................          (0.23)  ..............          (0.23)          (0.22)  ..............          (0.22)
Alternative Option--Total...............................            5.66  ..............            5.66            5.59  ..............            5.59

[[Page 10322]]

 
Alternative Option--Net Change..........................            0.54  ..............            0.54            0.67  ..............            0.67
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                Annual Site Visits
--------------------------------------------------------------------------------------------------------------------------------------------------------
1989 TCR--Total.........................................  ..............  ..............  ..............  ..............  ..............  ..............
RTCR--Total.............................................  ..............  ..............  ..............  ..............  ..............  ..............
RTCR--Net Change........................................  ..............  ..............  ..............  ..............  ..............  ..............
Alternative Option--Total...............................  ..............  ..............  ..............  ..............  ..............  ..............
Alternative Option--Net Change..........................  ..............  ..............  ..............  ..............  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                Level 1 Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
1989 TCR--Total.........................................            1.13            0.21            1.34            1.08            0.20            1.29
RTCR--Total.............................................            1.63            0.20            1.84            1.57            0.20            1.77
RTCR--Net Change........................................            0.51          (0.01)            0.50            0.49          (0.01)            0.48
Alternative Option--Total...............................            1.76            0.23            1.99            1.72            0.23            1.94
Alternative Option--Net Change..........................            0.63            0.02            0.65            0.63            0.02            0.65
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                Level 2 Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
1989 TCR--Total.........................................            0.70            0.26            0.96            0.68            0.25            0.92
RTCR--Total.............................................            0.90            0.19            1.08            0.88            0.18            1.06
RTCR--Net Change........................................            0.20          (0.07)            0.12            0.20          (0.07)            0.13
Alternative Option--Total...............................            1.26            0.29            1.55            1.30            0.31            1.61
Alternative Option--Net Change..........................            0.55            0.03            0.58            0.62            0.06            0.68
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Corrective Actions Based on Level 1 Assessments
--------------------------------------------------------------------------------------------------------------------------------------------------------
1989 TCR--Total.........................................  ..............  ..............  ..............  ..............  ..............  ..............
RTCR--Total.............................................            9.62            0.01            9.63            8.14            0.01            8.15
RTCR--Net Change........................................            9.62            0.01            9.63            8.14            0.01            8.15
Alternative Option--Total...............................           10.01            0.01           10.02            8.52            0.01            8.53
Alternative Option--Net Change..........................           10.01            0.01           10.02            8.52            0.01            8.53
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Corrective Actions Based on Level 2 Assessments
--------------------------------------------------------------------------------------------------------------------------------------------------------
1989 TCR--Total.........................................  ..............  ..............  ..............  ..............  ..............  ..............
RTCR--Total.............................................            2.82            0.00            2.82            2.49            0.00            2.49
RTCR--Net Change........................................            2.82            0.00            2.82            2.49            0.00            2.49
Alternative Option--Total...............................            3.78            0.01            3.79            3.57            0.01            3.58
Alternative Option--Net Change..........................            3.78            0.01            3.79            3.57            0.01            3.58
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                Public Notification
--------------------------------------------------------------------------------------------------------------------------------------------------------
1989 TCR--Total.........................................            3.75            0.44            4.19            3.60            0.42            4.02
RTCR--Total.............................................            0.26            0.06            0.32            0.25            0.06            0.31
RTCR--Net Change........................................          (3.49)          (0.38)          (3.86)          (3.35)          (0.36)          (3.71)
Alternative Option--Total...............................            0.35            0.08            0.43            0.35            0.08            0.44
Alternative Option--Net Change..........................          (3.40)          (0.36)          (3.76)          (3.25)          (0.34)          (3.58)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Detail may not add due to independent rounding.
Assumes a certain level of assessment activity already occurs under the 1989 TCR, as discussed in Chapter 7 of the RTCR EA (USEPA 2012a).
Not all 1989 TCR components are quantified. For components not quantified for the 1989 TCR, only the net increase in the costs of these components is
  considered for the RTCR and Alternative option (e.g., corrective action costs).
Source: RTCR EA (USEPA 2012a).

2. PWS Costs
    Like the 1989 TCR, the RTCR applies to all PWSs. Exhibit VI-17 
presents the total and net change in annualized costs to PWSs by size 
and type for the three regulatory options. No net change in costs will 
result from a continuation of the 1989 TCR. Among PWSs serving 4,100 or 
fewer people, looking at the three percent discount rate, the largest 
increase in aggregate net costs is incurred by the TNCWSs serving 100 
or fewer people under either the RTCR ($5.3M) or Alternative option 
($14.7M) because of the large number of systems. On a per system basis, 
this translates to a net annualized present value increase of 
approximately $86 per system under the RTCR and $240 per system under 
the Alternative option for the TNCWSs serving 100 or fewer people. As 
described in section VII.C of this preamble, Regulatory Flexibility Act 
(RFA), none of the small TNCWSs are estimated to have costs that are 
greater than or equal to three percent of their revenue and only 61 
small systems (0.04%) are estimated to have costs greater than or equal 
to one percent of their revenue.
    The total net change in national annualized present value costs for 
all

[[Page 10323]]

PWSs serving greater than 4,100 people (approximately $5.6M using three 
percent discount rate) is the same under the RTCR and Alternative 
option. This is expected because the provisions for PWSs serving 
greater than 4,100 are the same under the RTCR and the Alternative 
option. Monitoring requirements for PWSs serving greater than 4,100 
people remain essentially unchanged under either the RTCR or 
Alternative option. The observed overall net increase in costs for PWSs 
serving greater than 4,100 people is driven primarily by the 
requirements to conduct assessments and to correct any sanitary defects 
that are found.

                                  Exhibit VI-17--Total and Net Change in Annualized Costs to PWSs by PWS Size and Type
                                                                   [$Millions, 2007$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         3% discount rate                                           7% discount rate
                                   ---------------------------------------------------------------------------------------------------------------------
   PWS Size (population served)       1989                          Alternative                  1989                          Alternative
                                      TCR      RTCR     RTCR Net       option     Alternative    TCR      RTCR     RTCR net       option     Alternative
                                     Total    Total                    total      option net    total    total                    total      option net
                                          A        B     C = B - A           D      E = D - A        F        G     H = G - F           I      J = I - F
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Community Water Systems (CWSs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1M...............................      5.6      5.6         (0.0)         5.6          (0.0)      5.3      5.3         (0.0)         5.3          (0.0)
                                   ---------------------------------------------------------------------------------------------------------------------
    Total.........................    157.4    163.9           6.5       164.1            6.7    151.3    157.2           5.9       157.5            6.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Nontransient Noncommunity Water Systems (NTNCWSs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1M...............................      0.0      0.0           0.0         0.0            0.0      0.0      0.0           0.0         0.0            0.0
                                   ---------------------------------------------------------------------------------------------------------------------
    Total.........................      6.9      7.3           0.4         9.3            2.5      6.6      7.2           0.6         9.6            3.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Transient Noncommunity Water Systems(TNCWSs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1M...............................      0.3      0.3           0.0         0.3            0.0      0.3      0.3           0.0         0.3            0.0
                                   ---------------------------------------------------------------------------------------------------------------------
    Total.........................     20.9     28.1           7.3        41.0           20.1     20.1     27.3           7.3        42.0           21.9
                                   ---------------------------------------------------------------------------------------------------------------------
        Grand Total...............    185.2    199.3          14.2       214.4           29.3    177.9    191.7          13.8       209.0           31.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Detail may not add due to independent rounding. Because only the incremental costs of some rule components are considered as part of the cost
  analysis, references to ``total'' costs in this exhibit do not refer to complete costs for regulatory implementation but only to specific costs
  considered to calculate net change in costs.
Source: RTCR cost model.

    The following subsections discuss the different components of the 
costs to PWSs: Rule implementation and annual administration, sample 
siting plan revision, monitoring, annual site visits, assessments, 
corrective actions, and public notification.
    a. Rule implementation and annual administration. Under the RTCR 
and Alternative option, all PWSs subject to the RTCR incur one-time 
costs that include time for staff to read the RTCR, become familiar 
with its provisions, and to train employees on rule requirements. No 
additional implementation burden or costs will be incurred by PWSs if 
the 1989 TCR option is maintained. Under the RTCR and Alternative 
option, all PWSs subject to the RTCR perform additional or transitional 
implementation activities. Based on previous experience with rule 
implementation, EPA estimated that

[[Page 10324]]

PWSs require a total of four hours to read and understand the rule, and 
a total of eight hours to plan and assign appropriate personnel and 
resources to carry out rule activities. EPA estimated a net increase in 
national annualized cost estimates incurred by PWSs for rule 
implementation and annual administration of $2.77M (three percent 
discount rate) and $4.00M (seven percent discount rate) under either 
the RTCR or the Alternative option. The annualized net present value 
total and net change cost estimates for PWSs for rule implementation 
and annual administration under the 1989 TCR, RTCR, and Alternative 
option are presented in Exhibit VI-16 of this preamble.
    b. Sample siting plan revision. Under the RTCR and Alternative 
option, all PWSs subject to the RTCR incur one-time costs to revise 
existing sample siting plans to identify sampling locations and 
collection schedules that are representative of water throughout the 
distribution system. Under the 1989 TCR, no additional burden or costs 
are expected to be incurred by PWSs to revise sample siting plans, as 
these PWSs are already collecting total coliform samples in accordance 
with a written sample siting plan. Based on previous experience, EPA 
estimated that PWSs require two to eight hours to revise their sample 
siting plan, depending on PWS size. EPA estimated a net increase in 
national annualized cost estimates incurred by PWSs for revising sample 
siting plans of $0.59M (three percent discount rate) and $0.84M (seven 
percent discount rate) under either the RTCR or the Alternative option. 
The annualized net present value total and net change cost estimates 
for PWSs to revise their sample siting plan under the 1989 TCR, RTCR, 
and Alternative option are presented in Exhibit VI-16 of this preamble.
    c. Monitoring. Monitoring costs for PWSs are calculated by 
multiplying the total numbers of routine, additional routine, and 
repeat samples required under the 1989 TCR, RTCR, and Alternative 
options by the monitoring costs per sample. Under the RTCR, the 
increased stringency to qualify for reduced monitoring results in more 
routine samples being taken over time (fewer PWSs are on reduced 
monitoring) compared to the 1989 TCR. For the Alternative option, this 
effect is combined with the requirement that all PWSs start the 
implementation period on monthly monitoring. The Alternative option 
also prohibits annual monitoring, resulting in a greater increase in 
the number of routine samples compared to the RTCR. Costs for routine 
monitoring under the RTCR and Alternative option are higher than 
routine monitoring costs under the 1989 TCR.
    The overall reductions in the numbers of additional routine samples 
required under the RTCR and Alternative option result in lower costs 
for additional routine monitoring when compared to the 1989 TCR. Under 
the RTCR and Alternative option, additional routine monitoring is no 
longer required for systems that monitor at least monthly, and when 
additional routine monitoring is required, the number of samples 
required is reduced from five to three. Cost reductions are greater 
under the Alternative option than under the RTCR because under the 
Alternative option all PWSs start on monthly monitoring and are not 
required to take additional routine samples during that period.
    Costs for repeat sampling are also lower under the RTCR and 
Alternative option. Under the 1989 TCR, PWSs serving 1,000 or fewer 
people take four repeat samples, at and within five service connections 
upstream and downstream of the initial total coliform positive 
occurrence location, over the course of 24 hours following the event. 
Under the RTCR and Alternative option, PWSs serving 1,000 or fewer 
people will need to take only three repeat samples, and they have 
greater flexibility about where to take them, consistent with the 
system sample siting plan that is developed in accordance with RTCR 
requirements and subject to review and revision by the State. The 
number of repeat samples required for PWSs serving more than 1,000 
people is the same under the 1989 TCR and the RTCR and Alternative 
option, although these systems also have greater flexibility in sample 
location.
    Exhibit VI-18 summarizes the cumulative number of samples taken by 
PWS size and category for routine, additional, and repeat monitoring 
under the 1989 TCR, RTCR, and Alternative option over the entire 25-
year period of analysis. Under the 1989 TCR option, approximately 82.1M 
samples are taken over the 25-year period of analysis compared to 
approximately 82.2M samples under the RTCR and approximately 87.9M 
samples under the Alternative option (less than 10 percent more than 
1989 TCR option). Appendix A of the RTCR EA presents additional 
information on the number of samples taken each year during the 
analysis period.

             Exhibit VI-18--Cumulative Number of Samples over 25-Year Period of Analysis for Baseline (1989 TCR) and Regulatory Alternatives
                                                              [RTCR and Alternative option]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    1989 TCR                                 RTCR                               Alternative
                                    --------------------------------------------------------------------------------------------------------------------
                                                   Additional                             Additional                             Additional
    PWS Size (population served)       Routine      routine       Repeat      Routine      routine       Repeat      Routine      routine       Repeat
                                      monitoring   monitoring   monitoring   monitoring   monitoring   monitoring   monitoring   monitoring   monitoring
                                       samples      samples      samples      samples      samples      samples      samples      samples      samples
                                               A            B            C            D            E            F            G            H            I
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Community Water Systems (CWSs)--Surface Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
1M................................    1,686,960  ...........       29,616    1,686,960  ...........       28,812    1,686,960  ...........       28,812
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................   38,686,502      120,642      711,259   38,729,592  ...........      679,350   38,729,592  ...........      679,350
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 10325]]

 
                                                      Community Water Systems (CWSs)--Ground Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
1M................................      269,280  ...........        6,778      269,280  ...........        6,399      269,280  ...........        6,399
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................   27,727,648      761,481      933,279   27,923,956       16,731      822,439   28,012,784       14,425      824,956
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                            Nontransient Noncommunity Water Systems (NTNCWSs)--Surface Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
1M................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........  ...........  ...........
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................      312,223       12,065       13,138      315,216  ...........       10,536      315,216  ...........       10,536
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                             Nontransient Noncommunity Water Systems (NTNCWSs)--Ground Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
1M................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........  ...........  ...........
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................    2,525,850      239,551      163,913    2,441,617       79,938      134,426    3,191,322       61,149      173,343
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              Transient Noncommunity Water Systems (TNCWSs)--Surface Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
1M................................      102,960  ...........  ...........      102,960  ...........        5,636      102,960  ...........        5,636
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................      680,015       62,596       50,434      693,792  ...........       43,020      693,792  ...........       43,020
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               Transient Noncommunity Water Systems (TNCWSs)--Ground Water
--------------------------------------------------------------------------------------------------------------------------------------------------------
1M................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........  ...........  ...........
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................    6,901,647    1,284,478      868,188    8,852,088      596,065      874,801   13,479,275      448,667    1,252,181
                                    --------------------------------------------------------------------------------------------------------------------
        Grand Total................   76,833,885    2,480,814    2,740,210   78,956,260      692,734    2,564,572   84,421,981      524,241    2,983,387
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: (B), (E), (H) For modeling purposed, additional routine sample counts include regular routine samples taken in the same month.
Source: Appendix A of the RTCR EA (USEPA 2012a)--Total PWS Counts (A.1z, A.2z, A.3z).

[[Page 10326]]

    The annualized total and net change cost estimates for PWSs to 
perform monitoring under the 1989 TCR, RTCR, and Alternative option are 
presented in Exhibit VI-19. EPA estimated a net increase in national 
annualized cost estimates incurred by PWSs for monitoring of $1.14M 
(three percent discount rate) and $0.95M (seven percent discount rate) 
under the RTCR and a net increase of $14.36M (three percent discount 
rate) and $16.15M (seven percent discount rate) under the Alternative 
option. See also Exhibit VI-16 of this preamble for a breakdown on the 
costs of monitoring (i.e., routine, additional routine, repeat).

    Exhibit VI-19--Annualized National PWS Monitoring Cost Estimates
                           [$Millions, 2007$]
------------------------------------------------------------------------
                                3% discount rate      7% discount rate
------------------------------------------------------------------------
1989 TCR--Total.............               $179.57               $172.57
RTCR--Total.................               $180.71               $173.52
RTCR--Net Change............                 $1.14                 $0.95
RTCR--Percent Change........                 0.63%                 0.55%
Alternative option--Total...               $193.93               $188.72
Alternative option--Net                     $14.36                $16.15
 Change.....................
Alternative option--Percent                  7.99%                 9.36%
 Change.....................
------------------------------------------------------------------------
Note: Detail may not add due to independent rounding.
Source: RTCR EA (USEPA 2012a).

    The overall estimated increase in monitoring costs seen under the 
RTCR is driven by increases in routine monitoring due to stricter 
requirements to qualify for reduced monitoring. However, this is mostly 
offset by reductions in additional routine and repeat monitoring. For 
the Alternative option, the requirement for all PWSs to sample on a 
monthly basis at the beginning of rule implementation results in a much 
larger cost differential that is only partially offset by reduced costs 
from reductions in additional routine monitoring requirements.
    d. Annual site visits. Under the RTCR, any PWS on an annual 
monitoring schedule is required to also have an annual site visit 
conducted by the State or State-designated third party. A voluntary 
Level 2 site assessment can also satisfy the annual site visit 
requirement. For years in which the State performs a sanitary survey 
(at least every five years for NCWSs and three years for CWSs), a 
sanitary survey performed during the same year can also be used to 
satisfy this requirement. Although similar site visits are not 
currently required under the 1989 TCR, discussions with States during 
the TCRDSAC proceedings revealed that some do, in fact, conduct such 
site visits for PWSs on annual monitoring schedules. Because of the 
high cost for an annual site visit by a State, for this analysis EPA 
assumed that no States choose to conduct annual site visits unless they 
already do so under the 1989 TCR. Therefore, for overall costing 
purposes, no net change in PWS or State costs are assumed for annual 
monitoring site visits under the RTCR or Alternative option.
    e. Assessments. Annualized cost estimates for Level 1 and Level 2 
assessments under the 1989 TCR, RTCR, and Alternative option are 
calculated in the RTCR EA by multiplying the number of assessments 
estimated by the predictive modeling (summarized in Exhibit 7.13 of the 
EA) by the unit costs (summarized in Exhibits 7-11 and 7-12 of the EA). 
Appendix A of the RTCR EA provides a detailed breakout of the number of 
Level 1 and Level 2 assessments estimated by the occurrence model. EPA 
estimated a net increase in national annualized cost estimates incurred 
by PWSs for conducting assessment of $0.70M (three percent discount 
rate) and $0.69M (seven percent discount rate) under the RTCR and a net 
increase of $1.18M (three percent discount rate) and $1.25M (seven 
percent discount rate) under the Alternative option. Annualized cost 
estimates are presented in Exhibit VI-16 of this preamble.
    Under the RTCR, all PWSs are required to conduct assessments of 
their systems when they exceed Level 1 or Level 2 treatment technique 
triggers. While PWSs are not required to conduct assessments under the 
1989 TCR, some PWSs do currently engage in assessment activity (which 
may or may not meet the RTCR criteria) following non-acute and acute 
MCL violations. EPA estimates both the costs to PWSs to conduct 
assessments under the RTCR as well as the level of effort that PWSs 
already put toward assessment activities under the 1989 TCR. These 
estimates are based on the work of the stakeholders in the Technical 
Work Group (TWG) during the proceedings of the TCRDSAC. These estimates 
allowed EPA to determine the average net costs to conduct assessments 
under the RTCR. EPA assumes that the numbers of non-acute and acute MCL 
violations would remain steady under a continuation of the 1989 TCR 
based on the review of SDWIS/FED violation data. Under the RTCR, EPA 
assumes that the numbers of assessment triggers decrease over time from 
the steady state level estimate based on the 1989 TCR to a new steady 
state level, as a result of reduced fecal indicator occurrence 
associated with the beneficial effects of requiring assessments and 
corrective action.
    The overall number of assessments is larger under the Alternative 
option compared to the RTCR option. This is a result of the initial 
monthly monitoring requirements for all PWSs under the Alternative 
option. The modeling results indicate that a greater number of samples 
early in the implementation period results in more positive samples and 
associated assessments despite the predicted long term reductions in 
occurrence as informed by the assumptions. This increase in total 
assessments performed, combined with the higher unit cost of performing 
assessments compared to existing practices under the 1989 TCR, results 
in a higher net cost increase for the Alternative option than under the 
RTCR. The total net increase in cost for the Alternative option is 
estimated to be nearly twice that of the RTCR option. See Exhibit 7.15 
of the RTCR EA.
    f. Corrective actions. Under the RTCR and Alternative option, all 
PWSs are required to correct sanitary defects found through the 
performance of Level 1 or Level 2 assessments. For modeling purposes, 
EPA estimated the net change in the number of corrective actions 
performed under the RTCR and Alternative option. For ground water 
systems, EPA assumed that any corrective actions based on a positive 
source water sample are accounted for

[[Page 10327]]

under the GWR and not under the RTCR. Based on discussions with State 
representatives, EPA assumed that an additional 10 percent of 
corrective actions will be performed as a result of the assessment and 
corrective action requirements of the RTCR, representing the net 
increase of the RTCR over the 1989 TCR.
    To estimate the costs incurred for the correction of sanitary 
defects, EPA assumed the percent distribution of PWSs that perform 
different types of corrective actions as presented in the compliance 
forecast shown in Exhibit VI-20 (i.e., distribution of the additional 
10 percent of corrective actions) based on best professional judgment 
and stakeholder input. The compliance forecast presented in this 
section was informed by discussions of the TCRDSAC Technical Work Group 
and focuses on broad categories of types of corrective actions 
anticipated. EPA used best professional judgment and stakeholder input 
to make simplifying assumptions on the distribution of these categories 
that are implemented by different systems based on size and type of 
system. For each of the categories listed, a PWS is assumed to take a 
specific action that falls under that general category. Detailed 
compliance forecasts showing the specific corrective actions used in 
the cost analysis are provided in Appendix D of the RTCR EA, along with 
summary tables of the unit costs used in the analysis. Each corrective 
action in the detailed compliance forecast is also assigned a 
representative unit cost. Detailed descriptions of the derivation of 
unit costs are provided in Exhibits 5-1 through 5-47 of the Technology 
and Cost Document for the Revised Total Coliform Rule (USEPA 2012b).

                                               Exhibit VI-20--Compliance Forecast for Corrective Actions Based on Level 1 and Level 2 Assessments
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                       Maintenance                               Cross-     Addition                Development
                                                                              Replace/                      of                                 connection  or upgrade   Addition        and
                                                         PWS      Sampler     Repair of   Maintenance  appropriate    Storage       Booster      control    of online      of     implementation
       PWS Size (population served)  (percent)         flushing   training  distribution  of adequate   hydraulic     facility   disinfection      and     monitoring   security       of an
                                                      (percent)  (percent)     system       pressure    residence   maintenance    (percent)    backflow       and      measures    operations
                                                                             components    (percent)       time       (percent)                prevention    control   (percent)       plan
                                                                              (percent)                 (percent)                               (percent)   (percent)                (percent)
                                                              A          B            C            D            E            F             G            H           I          J             K
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                   Level 1 Compliance Forecast
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1M.................................................         39         15           12            9            8            6             4            1           3          1             2
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                   Level 2 Compliance Forecast
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1M.................................................         15          4           18           15           15           11             8            2           6          2             4
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Source: (A)-(K) Percent of PWSs performing corrective actions based on Level 1 and Level 2 assessments reflect EPA estimates.

    Level 1 assessments generally are less involved than Level 2 
assessments and may result in finding less complex problems. As shown 
in the compliance forecast in Exhibit VI-20, EPA estimated that 
corrective actions found through Level 1 assessments result in 
corrective actions that focus more on transient solutions or training 
(columns A and B) than on permanent fixes to the PWS. However, in the 
case of flushing, EPA assumed that in a majority of instances, PWSs 
implement a regular flushing program as opposed to a single flushing, 
based on EPA and stakeholder best professional judgment.
    Corrective actions taken as a result of Level 2 assessments are 
expected to find a higher proportion of structural/technical issues 
(columns C-K) resulting in material fixes to the PWSs and distribution 
system. Consistent with the discussions of the TCRDSAC regarding major 
structural fixes or replacements, EPA did not include these major costs 
in the analysis. Distribution system appurtenances such as storage 
tanks and water mains generally have a useful life that is accounted 
for in water system capital planning. The assessments conducted in 
response to RTCR triggers could identify when that useful life has 
ended but are not solely responsible for the need to correct the 
defect. In addition, EPA ran two sensitivity analyses to assess the 
potential impacts of different distributions within the compliance 
forecast. Results of the sensitivity analyses are presented in Exhibit 
VI-21, which indicates that the low bound estimates of annualized net 
change in costs at three percent discount rate are approximately $3M 
for the RTCR and $17M for the Alternative option, and the high bound 
estimates are approximately $25M for the RTCR and $43M for the 
Alternative option. Varying the assumptions about the percentage of 
corrective actions identified and the effectiveness of those actions 
had less than a linear effect on outcomes, and the RTCR continues to be 
less costly than the Alternative option under all scenarios modeled.

[[Page 10328]]

             Exhibit VI-21--Sensitivity Analysis--Annualized Net Change in Costs Based on Changes in Compliance Forecast ($Millions, 2007$)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         3% discount rate                                7% discount rate
                                                         -----------------------------------------------------------------------------------------------
                                                               PWSs            State           Total           PWSs            State           Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
RTCR Net Change.........................................           14.15            0.15           14.30           13.75            0.42           14.17
RTCR Low Bound Net Change...............................            2.61            0.15            2.75            3.91            0.42            4.33
RTCR High Bound Net Change..............................           25.10            0.15           25.25           23.63            0.42           24.05
Alternative Option Net Change...........................           29.29            0.31           29.60           31.09            0.61           31.69
Alternative Option Low Bound Net Change.................           16.54            0.31           16.84           19.93            0.61           20.54
Alternative Option High Bound Net Change................           42.68            0.31           42.99           43.63            0.61           44.24
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Detail may not add due to independent rounding.
Source: RTCR cost model, described in chapter 7 of the RTCR EA (USEPA 2012a).

    As indicated in the more detailed analysis presented in chapter 7 
of the RTCR EA, PWSs also incur reporting and recordkeeping burden to 
notify the State upon completion of each corrective action. PWSs may 
also consult with the State or with outside parties to determine the 
appropriate corrective action to be implemented.
    Annualized cost estimates for PWSs to perform corrective actions 
are estimated by multiplying the number of Level 1 and Level 2 
corrective actions estimated by the predictive model, (i.e., 10 percent 
of Level 1 and Level 2 assessments) by the percentages in the 
compliance forecast and unit costs of corrective actions and associated 
reporting and recordkeeping. Exhibit 7.13 of the RTCR EA presents the 
estimated totals of non-acute and acute MCL violations (1989 TCR) and 
Level 1 and Level 2 assessments (RTCR and Alternative option). The 
model predicts a total of approximately 109,000 single non-acute MCL 
violations, 58,000 cases of a second non-acute MCL violation, and 
16,000 acute MCL violations for the 1989 TCR, under which some PWSs 
currently engage in assessment activity which may or may not meet the 
RTCR criteria (see section 7.4.5 of the RTCR EA for details). For the 
RTCR, the model predicts approximately 104,000 Level 1 assessments and 
52,000 Level 2 assessments. For the Alternative option, the model 
predicts approximately 120,000 Level 1 assessments and 81,000 Level 2 
assessments. EPA estimated a net increase in national annualized cost 
estimates incurred by PWSs for conducting corrective actions of $12.44M 
(three percent discount rate) and $10.63M (seven percent discount rate) 
under the RTCR and a net increase of $13.79M (three percent discount 
rate) and $12.09M (seven percent discount rate) under the Alternative 
option. The annualized net present value total and net change cost 
estimates for PWSs to perform corrective actions under the 1989 TCR, 
RTCR, and Alternative option are presented in Exhibit VI-16 of this 
preamble.
    The differences in the net change in corrective action costs 
between the RTCR and Alternative option are a function of the different 
number of assessments estimated to be performed in the predictive 
model.
    g. Public notification. Estimates of PWS unit costs for PN are 
derived by multiplying PWS labor rates from section 7.2.1 of the RTCR 
EA and burden hour estimates derived from the Draft Information 
Collection Request for the Public Water System Supervision Program 
(USEPA 2008b). PWS PN unit cost estimates are presented in Exhibit 7.19 
of the RTCR EA.
    Total and net change in annualized costs for PN under the RTCR and 
Alternative option are estimated by multiplying the model estimates of 
PWSs with acute (Tier 1 public notification) and non-acute (Tier 2 
public notification) violations by the PWS unit costs for performing PN 
activities. The RTCR cost model assumed that all violations are 
addressed following initial PN, and no burden is incurred by PWSs for 
repeat notification. EPA estimated a net decrease in national 
annualized cost estimates incurred by PWSs for public notification of 
$3.49M (three percent discount rate) and $3.35M (seven percent discount 
rate) under the RTCR and a net decrease of $3.40M (three percent 
discount rate) and $3.25M (seven percent discount rate) under the 
Alternative option. The annualized total and net cost estimates for 
PWSs to perform public notification under the 1989 TCR, RTCR, and 
Alternative option are presented in Exhibit VI-16 of this preamble.
    A significant reduction in costs is estimated due to the 
elimination of Tier 2 public notification for non-acute/monthly MCL 
violations under both the RTCR and Alternative option.
3. State Costs
    EPA estimated that States as a group incur a net increase in 
national annualized present value costs under the RTCR of $0.2M (at 
three percent discount rate) and $0.4M (at seven percent discount rate) 
and under the Alternative option of $0.3M (at three percent discount 
rate) and $0.6M (at seven percent discount rate). State costs include 
implementing and administering the rule, revising sample siting plans, 
reviewing sampling results, conducting annual site visits, reviewing 
completed assessment forms, tracking corrective actions, and tracking 
public notifications. The costs presented in the RTCR EA are summary 
costs; costs to individual states vary based on state programs and the 
number and types of systems in the state. The following sections 
summarize the key assumptions that EPA made to estimate the costs of 
the RTCR and Alternative option to States. Chapter 7 of the RTCR EA 
provides a description of the analysis.
    a. Rule implementation and annual administration. States incur 
administrative costs to implement the RTCR. These implementation costs 
are not directly required by specific provisions of the RTCR 
alternatives, but are necessary for States to ensure the provisions of 
the RTCR are properly carried out. States need to allocate time for 
their staff to establish and maintain the programs necessary to comply 
with the RTCR, including developing and adopting State regulations and 
modifying data management systems to track new required PWS reports to 
the States. Time requirements for a variety of State agency activities 
and responses are estimated in this EA. Exhibit 7.4 of the RTCR EA 
lists the activities required to revise the program following 
promulgation of the RTCR along with their respective costs and burden 
including, for example, the net change

[[Page 10329]]

in State burden associated with tracking the monitoring frequencies of 
PWSs (captured under ``modify data management systems''). EPA estimated 
a net increase in national annualized cost estimates incurred by States 
for rule implementation of $0.18M (three percent discount rate) and 
$0.26M (seven percent discount rate) under either the RTCR or the 
Alternative option. Because time requirements for implementation and 
annual administration activities vary among State agencies, EPA 
recognizes that the unit costs used to develop national estimates may 
be an over- or under-estimate for some States. The annualized total and 
net change cost estimates for States to implement and administer the 
rule under the 1989 TCR, RTCR, and Alternative options are presented in 
Exhibit VI-16 of this preamble.
    b. Sample siting plan revision. Under the RTCR and Alternative 
option, States are expected to incur one-time costs to review sample 
siting plans and recommend any revisions to PWSs. Under the 1989 TCR 
option, no additional burden or costs are incurred by States to review 
sample siting plans, as these PWSs' sample siting plans have already 
been reviewed and approved. State costs are based on the number of PWSs 
developing revised sample siting plans each year. Based on previous 
experience, EPA estimated that States require one to four hours to 
review revised sample siting plans and provide any necessary revisions 
to PWSs, depending on PWS size. EPA estimated a net increase in 
national annualized cost estimates incurred by States for reviewing 
sample siting plans of $0.42M (three percent discount rate) and $0.59M 
(seven percent discount rate) under either the RTCR or the Alternative 
option. The annualized net present value total and net change cost 
estimates for States to review and revise sample siting plan under the 
1989 TCR, RTCR, and Alternative option are presented in Exhibit VI-16 
of this preamble.
    c. Monitoring. EPA assumed that States incur a monthly 15-minute 
burden to review each PWS's sample results under the 1989 TCR. This 
estimate reflects the method used to calculate reporting and 
recordkeeping burden under the 1989 TCR in the Draft Information 
Collection Request for the Microbial Rules (USEPA 2008a). Because the 
existing method calculates cost on a per PWS basis and the total number 
of PWSs is the same for cost modeling under the 1989 TCR and the RTCR 
and Alternative option, the net change in costs for reviewing 
monitoring results is assumed to be zero for the RTCR and Alternative 
option (as shown in Exhibit VI-16 of this preamble). Specific actions 
by States related to positive samples are accounted for under the 
actions required in response to those samples.
    d. Annual site visits. Under the RTCR, any PWS on an annual 
monitoring schedule is required to also have an annual site visit 
conducted by the State or State-designated third party. A voluntary 
Level 2 site assessment can also satisfy the annual site visit 
requirement. In many cases a sanitary survey performed during the same 
year can also be used to satisfy this requirement. Although similar 
site visits are not currently required under the 1989 TCR, discussions 
with States during the TCRDSAC proceedings revealed that some do, in 
fact, conduct such site visits for PWSs on annual monitoring schedules. 
Because of the high cost for an annual site visit by a State, for this 
analysis EPA assumed that no States choose to conduct annual site 
visits unless they already do so under the 1989 TCR. Therefore, for 
overall costing purposes, no net change in State or PWS costs are 
assumed for annual monitoring site visits under the RTCR or Alternative 
option (as shown in Exhibit VI-16 of this preamble).
    e. Assessments. States incur burden to review completed Level 1 and 
Level 2 assessment forms required to be filed by PWSs under the RTCR 
and Alternative option. Although specific forms are not required under 
the 1989 TCR, EPA assumes that PWSs engage in some form of consultation 
with the State when they have positive sample results and MCL 
violations. For costing purposes, EPA assumes that the level of effort 
required for such consultations under the 1989 TCR is the same as that 
which would be required for consultations that occur when an assessment 
is conducted under the RTCR and Alternative option. State costs for the 
RTCR and Alternative option are based on the number of PWSs submitting 
assessment reports. EPA estimated that State burden to review PWS 
assessment forms ranges from one to eight hours depending on PWS size 
and type and the level of the assessment. This burden includes any time 
required to consult with the PWS about the assessment report.
    Although some States may choose to conduct assessments for their 
PWSs, EPA does not quantify these costs. The costs are attributed to 
PWSs that are responsible for ensuring that assessments are done.
    As explained in chapter 7 of the RTCR EA, EPA assumes a certain 
level of assessment activity already occurs under the 1989 TCR based on 
discussions with the technical workgroup supporting the advisory 
committee. Under the RTCR, the overall number of Level 1 and Level 2 
assessment triggers decreases compared to the 1989 TCR as a function of 
reduced occurrence over time. This reduction in assessments under the 
RTCR is estimated to translate directly to a small national cost 
savings ($0.08M at either three or seven percent discount rate) for 
States. The overall number of Level 1 and Level 2 assessments is higher 
under the Alternative option as a result of the initial monthly 
monitoring requirements for all PWSs. The increase in the number of 
assessments under the Alternative option is estimated to translate 
directly to a national cost increase ($0.05M at three percent discount 
rate and $0.08M at seven percent discount rate) for States. The 
annualized net present value total and net change cost estimates for 
States to review completed Level 1 and Level 2 assessment forms under 
the 1989 TCR, RTCR, and Alternative option are presented in Exhibit VI-
16 of this preamble.
    f. Corrective actions. For each corrective action performed under 
the RTCR and Alternative option, States incur recordkeeping and 
reporting burden to review assessment forms and coordinate with PWSs. 
This includes burden incurred from any optional consultations States 
may conduct with PWSs or outside parties to determine the appropriate 
corrective action to be implemented. There are no State costs for 
corrective action under the 1989 TCR because corrective action is not 
required under the 1989 TCR. The number of corrective actions under the 
RTCR is estimated to translate to a national net annualized cost 
increase to States of $0.01M at either three or seven percent discount 
rate. The number of corrective actions under the Alternative option is 
estimated to translate to a national net annualized cost increase to 
States of $0.02M at either three or seven percent discount rate. See 
Exhibit VI-16 of this preamble.
    g. Public notification. Under the 1989 TCR, RTCR, and Alternative 
option, States incur recordkeeping and reporting burden to provide 
consultation, review the public notification certification, and file 
the report of the violation. A significant reduction in costs is 
estimated due to the elimination of Tier 2 public notification for non-
acute MCL violations under the RTCR and Alternative option. Because 
State costs are calculated on a per-violation basis, State costs 
decline. Under the

[[Page 10330]]

Alternative option, some of the decrease in cost is offset by 
additional Tier 1 public notification from the increase in the number 
of E. coli MCL violations detected. Burden hour estimate for State unit 
PN costs are derived from the Draft Information Collection Request for 
the Public Water System Supervision Program (USEPA 2008b). EPA 
estimated a net decrease in national annualized cost estimates incurred 
by States for public notification of $0.38M (three percent discount 
rate) and $0.36M (seven percent discount rate) under the RTCR and a net 
decrease of $0.36M (three percent discount rate) and $0.34M (seven 
percent discount rate) under the Alternative option. The annualized net 
present value total and net change cost estimates for States to track 
public notifications under the 1989 TCR, RTCR, and Alternative option 
are presented in Exhibit VI-16 of this preamble.
4. Nonquantifiable Costs
    EPA believes that all of the rule elements that are the major 
drivers of the net change in costs from the 1989 TCR have been 
quantified to the greatest degree possible. However, cost reductions 
related to fewer monitoring and reporting violations are not 
specifically accounted for in the cost analysis, and their exclusion 
from consideration may result in an overestimate of the net increase in 
cost between the 1989 TCR option and the RTCR or Alternative option.
    Furthermore, under the 1989 TCR, RTCR, and Alternative option, Tier 
3 public notification for monitoring and reporting violations are 
assumed to be reported once per year as part of the Consumer Confidence 
Reports (CCRs). Because of the use of the CCR to communicate Tier 3 
public notification on a yearly basis, no cost differential between the 
current 1989 TCR and the RTCR and Alternative option is estimated in 
the cost model. However, the advisory committee concluded that 
significant reductions in monitoring and reporting violations may be 
realized through the revised regulatory framework of the RTCR, which 
includes new consequences for failing to comply with monitoring 
provisions such as the requirement to conduct an assessment or 
ineligibility for reduced monitoring. These possible reductions have 
not been quantified. System resources used to process monitoring 
violation notices for the CCR and respond to customer inquiries about 
the notices, as well as State resources to remind systems to take 
samples, may be reduced if significant reductions in monitoring and 
reporting violations are realized. Exclusion of this potential cost 
savings may lead to an underestimate of the PN cost savings under both 
the RTCR and Alternative option.
    Additionally, as an underlying assumption to the costing 
methodology, EPA assumed that all PWSs subject to the RTCR requirements 
are already complying with the 1989 TCR. There may be some PWSs that 
are not in full compliance with the 1989 TCR, and if so, additional 
costs and benefits may be incurred. EPA does not anticipate non-
compliance when performing economic analyses for NPDWRs, therefore 
those costs and benefits are not captured in this analysis.

G. Potential Impact of the RTCR on Households

    The household cost analysis considers the potential increase in a 
household's annual water bill if a CWS passed the entire cost increase 
resulting from the rule on to their customers. This analysis is a tool 
to gauge potential impacts and should not be construed as a precise 
estimate of potential changes to household water bills. State costs and 
costs to TNCWSs and NTNCWSs are not included in this analysis since 
their costs are not typically passed through directly to households. 
Exhibit VI-22 presents the mean expected increases in annual household 
costs for all CWSs, including those systems that do not have to take 
corrective action. Exhibit VI-22 also presents the same information for 
CWSs that must take corrective action. Household costs tend to decrease 
as system size increases, due mainly to the economies of scale for the 
corrective actions.
    Exhibit VI-22 presents net costs per household under the RTCR and 
Alternative option for all rule components spread across all CWSs. 
Comparison to the 1989 TCR shows a cost savings for some households. 
The average annual water bill is expected to increase by six cents or 
less on average per year.
    While the average increase in annual household water bills to 
implement the RTCR is well less than a dollar, customers served by a 
small CWS that have to take corrective actions as a result of the rule 
incur slightly larger increases in their water bills. The subsequent 
categories of the exhibit present net costs per household for three 
different subsets of CWSs: (1) CWSs that perform assessments but no 
corrective actions, (2) CWSs that perform corrective actions, and (3) 
CWSs that do not perform assessments or corrective actions. 
Approximately 67 percent of households are served by CWSs that perform 
assessments but do not perform corrective actions over the 25-year 
period of analysis (because no sanitary defects are found). These 
households experience a slight cost savings on an annual basis, due to 
a slight reduction in monitoring and public notification costs. The 
nine percent of households belonging to CWSs that perform corrective 
actions over the 25-year period of analysis experience an increase in 
annual net household costs of less than $0.70 on average for CWSs 
serving greater than 4,100 people to approximately $4.50 on average for 
CWSs serving 4,100 or fewer people on an annual basis. EPA estimated 
that 24 percent of households are served by CWSs that do not perform 
assessments or corrective actions over the 25-year period of analysis 
because they never exceed an assessment trigger. This group of 
households served by small systems (4,100 or fewer people) experiences 
a slight cost change on an annual basis, comparable to those performing 
assessments but no corrective actions. Overall, the main driver of 
additional household costs under the RTCR is corrective actions.

                      Exhibit VI-22--Summary of Net Annual Per-Household Costs for the RTCR
                                                     [2007$]
----------------------------------------------------------------------------------------------------------------
                                                         3% discount rate                7% discount rate
                                                 ---------------------------------------------------------------
                                                                    Alternative                     Alternative
            Population served by PWS               RTCR Net cost    option net     RTCR Net cost    option net
                                                   per household     cost per      per household     cost per
                                                                     household                       household
----------------------------------------------------------------------------------------------------------------
                                       All Community Water Systems (CWSs)
----------------------------------------------------------------------------------------------------------------
 4,100.........................................            0.05            0.05            0.05            0.05
                                                 ---------------------------------------------------------------
    Total.......................................            0.06            0.06            0.05            0.05
----------------------------------------------------------------------------------------------------------------
        Community Water Systems (CWSs) performing Level 1/Level 2 Assessments (and no Corrective Actions)
----------------------------------------------------------------------------------------------------------------
 4,100.........................................          (0.01)          (0.01)          (0.01)          (0.01)
                                                 ---------------------------------------------------------------
    Total.......................................          (0.02)          (0.02)          (0.01)          (0.01)
----------------------------------------------------------------------------------------------------------------
                          Community Water Systems (CWSs) performing Corrective Actions
----------------------------------------------------------------------------------------------------------------
 4,100.........................................            0.66            0.66            0.55            0.55
                                                 ---------------------------------------------------------------
    Total.......................................            0.80            0.80            0.68            0.68
----------------------------------------------------------------------------------------------------------------
        Community Water Systems (CWSs) not performing Level 1/Level 2 Assessments, or Corrective Actions
----------------------------------------------------------------------------------------------------------------
 4,100.........................................  ..............  ..............  ..............  ..............
                                                 ---------------------------------------------------------------
    Total.......................................          (0.00)            0.00            0.01            0.02
----------------------------------------------------------------------------------------------------------------
Source: RTCR EA (USEPA 2012a).

H. Incremental Costs and Benefits

    The RTCR regulatory options achieve increasing levels of benefits 
at increasing levels of costs. The regulatory options for this rule, in 
order of increasing costs and benefits (Option 1 lowest and Option 3 
highest) are as follows:
     Option 1: 1989 TCR option
     Option 2: RTCR
     Option 3: Alternative option
    Incremental costs and benefits are those that are incurred or 
realized to reduce potential illnesses and deaths from one alternative 
to the next more stringent alternative. Estimates of incremental costs 
and benefits are useful when considering the economic efficiency of 
different regulatory alternatives considered by EPA. One goal of an 
incremental analysis is to identify the regulatory alternatives where 
net social benefits are maximized. However, incremental net benefits 
analysis is not possible when benefits are discussed qualitatively and 
are not monetized, as is the case with the RTCR.
    However, incremental analysis can still provide information on 
relative cost-effectiveness of different regulatory options. For the 
RTCR, only costs were monetized. While benefits were not quantified, an 
indirect proxy for benefits was quantified. To compare the additional 
net cost increases and associated incremental benefits of the RTCR and 
the Alternative option, benefits are presented in terms of corrective 
actions performed since performance of corrective actions is expected 
to have the impact that is most directly translatable into potential 
health benefits.
    Exhibit VI-23 shows the incremental cost of the RTCR over the 1989 
TCR and the Alternative option over the RTCR for costs annualized using 
three percent and seven percent discount rates. The non-monetized 
corrective action endpoints are discounted in order to make them 
comparable to monetized endpoints. The relationship between the 
incremental costs and benefits is examined further with respect to cost 
effectiveness in section VI.M of this preamble, Benefit Cost 
Determination for the RTCR.

            Exhibit VI--23 Incremental Net Change in Annualized Costs ($Millions, 2007$) and Benefits
                                         [Number of Corrective Actions]
----------------------------------------------------------------------------------------------------------------
                                         Costs ($millions)               Benefits (L2 corrective actions)
        Regulatory option        -------------------------------------------------------------------------------
                                        3%              7%                  3%                      7%
----------------------------------------------------------------------------------------------------------------
1989 TCR........................           186.1           178.8  No change \3\.........  No change \3\
RTCR............................           200.4           193.0  208...................  202
Incremental RTCR \1\............            14.3            14.2  208...................  202
Alternative Option..............           215.7           210.5  336...................  355
Incremental Alternative Option              15.3            17.5  128...................  153
 \2\.
----------------------------------------------------------------------------------------------------------------
\1\ Represents the incremental net change of the RTCR over the 1989 TCR option.

[[Page 10332]]

 
\2\ Represents the incremental net change of the Alternative option over the RTCR. Add incremental net change
  for Alternative option to incremental net change for RTCR to calculate the total net change of the Alternative
  option over the 1989 TCR option.
Note: The RTCR occurrence model yields the number of corrective actions that are expected to be implemented in
  addition to (net of) those already implemented under the 1989 TCR. The model does not incorporate an estimate
  of the number of corrective actions implemented per year under the 1989 TCR and does not yield a total for the
  RTCR and Alternative option that includes the 1989 TCR corrective actions. Benefits shown include corrective
  actions based on L2 assessments. Detailed benefits and cost information is provided in Appendices A and C,
  respectively, of the RTCR EA (USEPA 2012a).
\3\ As explained in section VI.F.2.f of this preamble, Corrective actions, for modeling purposes, EPA estimates
  the net change only in the number of corrective actions performed under the RTCR and Alternative option
  compared to the 1989 TCR and thus did not quantify the (non-zero) baseline number of corrective actions
  performed under the 1989 TCR.

I. Benefits From Simultaneous Reduction of Co-occurring Contaminants

    As discussed in section VI.E of this preamble, Anticipated Benefits 
of the RTCR, the potential benefits from the RTCR include avoidance of 
a full range of health effects from the consumption of fecally 
contaminated drinking water, including the following: acute and chronic 
illness, endemic and epidemic disease, waterborne disease outbreaks, 
and death.
    Systems may choose corrective actions that also reduce other 
drinking water contaminants as a result of the fact that the corrective 
action eliminates a pathway of potential contamination into the 
distribution system. For example, eliminating a cross connection 
reduces the potential for chemical contamination as well as microbial. 
Due to a lack of contamination co-occurrence data that could relate to 
the effect that treatment corrective action may have on contamination 
entering through distribution system pathways, EPA has not quantified 
such potential benefits.

J. Change in Risk From Other Contaminants

    All surface water systems are already required to disinfect under 
the SWTR (USEPA 1989b, 54 FR 27486, June 29, 1989) but the RTCR could 
impact currently undisinfected ground water systems. If a previously 
undisinfected ground water system chooses disinfection as a corrective 
action, the disinfectant can react with pipe scale causing increased 
risk from some contaminants that may be entrained in the pipe scales 
and other water quality problems. Examples of contaminants that could 
be released include lead, copper, and arsenic. Disinfection could also 
possibly lead to a temporary discoloration of the water as the scale is 
loosened from the pipe. These risks can be addressed by gradually 
phasing in disinfection to the system, by targeted flushing of 
distribution system mains, and by maintaining an effective corrosion 
control program.
    Introducing a disinfectant could also result in an increased risk 
from disinfection byproducts (DBPs). Risk from DBPs has already been 
addressed in the Stage 1 Disinfection Byproducts Rule (DBPR) (USEPA 
1998a) and additional consideration of DBP risk has been addressed in 
the final Stage 2 DBPR (USEPA 2006e). In general, ground water systems 
are less likely to experience high levels of DBPs than surface water 
systems because they have lower levels of naturally occurring organic 
materials that contribute to DBP formation.
    EPA does not expect many previously undisinfected systems to add 
disinfection as a result of either the RTCR or Alternative rule 
options. Ground water systems that are not currently disinfecting may 
eventually install disinfection if RTCR distribution system monitoring 
and assessments, and/or subsequent source water monitoring required 
under the GWR, result in the determination that source water treatment 
is required.

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

    It is anticipated that the requirements of the RTCR will help 
reduce pathways of entry for fecal contamination and/or waterborne 
pathogens into the distribution system, thereby reducing risk to both 
the general population as well as to sensitive subpopulations.
    As discussed previously in this preamble, fecal contamination may 
contain waterborne pathogens including bacteria, viruses, and parasitic 
protozoa. Waterborne pathogens can cause a variety of illnesses, 
including acute gastrointestinal illness (AGI) with diarrhea, abdominal 
discomfort, nausea, vomiting, and other symptoms. Most AGI cases are of 
short duration and result in mild illness. Other more severe illnesses 
caused by waterborne pathogens include hemolytic uremic syndrome (HUS) 
(kidney failure), hepatitis, and bloody diarrhea (WHO 2004). Chronic 
disease such as irritable bowel syndrome, reduced kidney function, 
hypertension and reactive arthritis can result from infection by a 
waterborne agent (Clark et al. 2008).
    Waterborne pathogens may subsequently infect other people through a 
variety of other routes (WHO 2004). When humans are exposed to and 
infected by an enteric pathogen, the pathogen becomes capable of 
reproducing in the gastrointestinal tract. As a result, healthy humans 
shed pathogens in their feces for a period ranging from days to weeks. 
This shedding of pathogens often occurs in the absence of any signs of 
clinical illness. Regardless of whether a pathogen causes clinical 
illness in the person who sheds it in his or her feces, the pathogen 
being shed may infect other people directly by person-to-person spread, 
contact with contaminated surfaces, and other means, which are 
collectively referred to as secondary spread.
    When sensitive subpopulations are exposed to fecal contamination 
and/or waterborne pathogens, more severe illness (and sometimes death) 
can occur. Examples of sensitive subpopulations are provided in chapter 
2 of the RTCR EA. The potential health effects associated with 
sensitive population groups--children, pregnant women, the elderly, and 
the immunocompromised--are described in the following paragraphs.
1. Risk to Children, Pregnant Women, and the Elderly
    Children and the elderly are particularly vulnerable to kidney 
failure (hemolytic uremic syndrome) caused by the pathogenic bacterium 
E. coli O157:H7. Kidney failure in children and the elderly have 
resulted from waterborne outbreaks due to exposure to E. coli O157:H7 
from 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

[[Page 10333]]

paralysis, myocarditis, encephalitis, hemorrhagic conjunctivitis, and 
diabetes mellitus (Dalldorf and Melnick 1965; Smith 1970; Berlin et al. 
1993; Cherry 1995; Melnick 1996; CDC 1997; Modlin 1997). Women may be 
at increased risk from enteric viruses during pregnancy (Gerba et al. 
1996). Enterovirus infections in pregnant women can also be transmitted 
to the unborn child late in pregnancy, sometimes resulting in severe 
illness in the newborn (USEPA 2000b).
    Other waterborne viruses can also be particularly harmful to 
children. Rotavirus disproportionately affects children less than five 
years of age (Parashar et al. 1998). However, the pentavalent rotavirus 
vaccine licensed for use in the United States has been shown to be 74 
percent effective against rotavirus gastroenteritis of any severity 
(Dennehy 2008). For echovirus, children are disproportionately at risk 
of becoming ill once infected (Modlin 1986). According to CDC, 
echovirus is not a vaccine-preventable disease (CDC 2007).
    The elderly are particularly at risk from diarrheal diseases (Glass 
et al. 2000) such as those associated with waterborne pathogens. In the 
US, approximately 53 percent of diarrheal deaths occur among those 
older than 74 years of age, and 77 percent of diarrheal deaths occur 
among 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 HUS (kidney failure), the others from gastrointestinal 
illness. Furthermore, hospitalizations due to diarrheal disease are 
higher in the elderly than younger adults (Glass et al. 2000). Average 
hospital stays for individuals older than 74 years of age due to 
diarrheal illness are 7.4 days compared to 4.1 days for individuals 
aged 20 to 49 (Glass et al. 2000).
    It is anticipated that the requirements of the RTCR will help 
reduce pathways of entry for fecal contamination and/or waterborne 
pathogens into the distribution system, thereby reducing risk to both 
the general population as well as to sensitive subpopulations such as 
children, pregnant women, and the elderly.
2. Risk to Immunocompromised Persons
    AGI symptoms may be more severe in immunocompromised persons 
(Frisby et al. 1997; Carey et al. 2004). Such persons include those 
with acquired immune deficiency syndrome (AIDS), cancer patients 
undergoing chemotherapy, organ transplant recipients treated with drugs 
that suppress the immune system, and patients with autoimmune disorders 
such as lupus. In AIDS patients, Cryptosporidium, a waterborne 
protozoa, has been found in the lungs, ear, stomach, bile duct, and 
pancreas in addition to the small intestine (Farthing 2000). 
Immunocompromised patients with severe persistent cryptosporidiosis may 
die (Carey et al. 2004).
    For the immunocompromised, Gerba et al. (1996) reviewed the 
literature and reported that enteric adenovirus and rotavirus are the 
two waterborne viruses most commonly isolated in the stools of AIDS 
patients. For patients undergoing bone-marrow transplants, several 
studies cited by Gerba et al. (1996) reported mortality rates greater 
than 50 percent among patients infected with enteric viruses.
    It is anticipated that the requirements of the RTCR will help 
reduce pathways of entry for fecal contamination and/or waterborne 
pathogens into the distribution system, thereby reducing risk to both 
the general population as well as to sensitive subpopulations such as 
the immunocompromised.

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

    A computer simulation model was used to estimate costs and 
indicators of benefits of the RTCR. Exhibit VI-24 shows that these 
outputs depend on a number of key model inputs. This section describes 
analyses that were conducted to understand how uncertainties in these 
inputs contributed to uncertainty in model outputs.

[[Page 10334]]

[GRAPHIC] [TIFF OMITTED] TR13FE13.007

1. Inputs and Their Uncertainties
    It is anticipated that the requirements of the RTCR will help 
reduce pathways of entry for fecal contamination and/or waterborne 
pathogens into the distribution system, thereby reducing exposure and 
illness from these contaminants in drinking water. These exposure and 
illness reductions could not be modeled and estimated quantitatively, 
due to a lack of a quantitative relationship between indicators and 
pathogens. Section VI.E.3 of this preamble, Nonquantifiable benefits, 
and chapter 6 of the RTCR EA discuss this issue qualitatively.
    Model outputs include two important indicators that are used to 
qualitatively describe benefits: E. coli occurrence in routine total 
coliform samples and the occurrence of Level 1 and 2 assessments. These 
outputs were monitored as endpoints in the sensitivity analyses 
described in this section.
    Quantified national cost estimates include costs of required 
monitoring, assessments, corrective actions, and public notifications. 
Total costs were monitored as end-points in the sensitivity analyses 
described in this section.
    None of the inputs shown in Exhibit VI-24 is perfectly known, so 
each has some degree of uncertainty. Some of these inputs are informed 
directly by data, so their uncertainties are due to limitations of the 
data. For example, uncertainty about the statistical model used to 
characterize occurrence is due to the limited numbers of systems and 
measurements per system in the Six-Year Review 2 dataset. Other inputs 
are informed by professional judgment, so their uncertainties are 
expressed in terms of reasonable upper and lower bounds that are, 
themselves, based on expert judgment. For example, 10 percent of 
assessments (representing the incremental increase over the 1989 TCR) 
are expected to result in effective corrective actions, based on 
professional judgment, with reasonable upper and lower bounds of 20 
percent and 5 percent, respectively.
    Sensitivity analyses were conducted to assess the degree to which 
uncertainties about selected inputs contribute to uncertainty in the 
resulting cost estimates. The analyses focused on the inputs that are 
listed in Exhibit VI-24. Varying the assumptions about the percentages 
of corrective actions identified and the effectiveness of those actions 
has a less than linear effect on outcomes, and the RTCR continues to be 
less costly than the Alternative option under all scenarios modeled. 
Exhibits 5.22a and 5.22b of the RTCR EA provide summaries of the 
driving model parameters and indicate where in the RTCR EA the full 
discussion of uncertainty on each parameter is contained.

[[Page 10335]]

    Not shown in Exhibit VI-24 are some inputs that are very well 
known. These are inventory data, which include the list of all PWSs 
affected by the RTCR and, for each system, information on its source 
water type, disinfection practice, and population served. Although this 
information is not perfect, any uncertainty is believed to have 
negligible impact on model outputs. EPA did not conduct sensitivity 
analyses to evaluate the importance of these small uncertainties.
2. Sensitivity Analysis
    Default values of the model inputs are considered reasonable best-
estimates. Model outputs that are obtained when the inputs are set to 
these default values are also considered to be reasonable best-
estimates. EPA conducted sensitivity analyses to learn how much the 
outputs might change when individual inputs are changed from their 
default values. The approach taken was to change each input to some 
reasonable upper and lower bounds, based on professional judgment.
    Many of the uncertainties are expected to impact the model output 
in a similar fashion for the 1989 TCR, RTCR, and the Alternative 
option. For example, an increase in a total coliform occurrence tends 
to increase the total cost and benefit estimates for all of the rule 
alternatives. Because the benefit and cost analyses focus on net 
changes among the 1989 TCR, RTCR, and Alternative option, these common 
sources of uncertainty may tend to cancel out in the net change 
analyses. Other uncertainties were expected to have stronger influence 
on net changes among the 1989 TCR, RTCR, and Alternative option because 
of their unequal influence on the options. For example, assumptions 
about the effectiveness of corrective actions influences total costs of 
the RTCR and Alternative option, but not the 1989 TCR option.
    Results of the sensitivity analyses (reported in the RTCR EA) 
showed that the fundamental conclusions of the economic analysis do not 
change over a wide range of assumptions. Both the RTCR and Alternative 
option provide benefits as compared to the 1989 TCR. Varying key 
assumptions has a less than linear effect on outcomes, and the RTCR 
continues to be less costly than the Alternative option under all 
scenarios modeled. See section 5.3.3.1 of the RTCR EA for details.

M. Benefit Cost Determination for the RTCR

    Pursuant to SDWA section 1412(b)(6)(A), EPA has determined that the 
benefits of the RTCR justify the costs. In making this determination, 
EPA considered quantified and nonquantified benefits and costs as well 
as the other components of the HRRCA outlined in section 1412(b)(3)(C) 
of the SDWA.
    Additionally, EPA used several other techniques to compare benefits 
and costs including a break-even analysis and a cost effectiveness 
analysis. EPA developed a break-even analysis to inform the discussion 
of whether the benefits justify the cost of the regulation. The break-
even analysis (see chapter 9 of the RTCR EA) was conducted using two 
example pathogens responsible for some (unknown) proportion of 
waterborne illnesses in the United States: shiga toxin-producing E. 
coli O157:H7 \2\ (STEC O157:H7) and Salmonella. In the break-even 
analysis, CDC and Economic Research Service (ERS) estimates were used 
for STEC O157:H7 and Salmonella infections, respectively. Valuations of 
medical cases were developed using the ERS Foodborne Illness 
Calculator. Chapter 9 of the RTCR EA has a complete discussion of the 
break even analysis and how costs per case were calculated.
---------------------------------------------------------------------------

    \2\ According to the 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.''
---------------------------------------------------------------------------

    Based on either example pathogen considered in the breakeven 
analysis, a small number of fatal cases annually would need to be 
avoided, relative to the CDC's estimate of cases caused by waterborne 
pathogens, in order to break even with rule costs. For example, under 
the RTCR, just two deaths would need to be avoided annually using a 
three percent discount rate based on consideration of the bacterial 
pathogen STEC O157:H7. Alternatively, approximately 3,000 or 8,000 non-
fatal cases, using the enhanced or traditional benefits valuations 
approaches,\3\ respectively, would need to be avoided to break even 
with rule costs. As expected based on its costs, the lower cost of the 
RTCR relative to the Alternative option means that fewer cases need to 
be avoided in order to break even. See Exhibit VI-25.
---------------------------------------------------------------------------

    \3\ Both traditional and enhanced cost of illness (COI) 
approaches count the value of the direct medical costs and of time 
lost that would been spent working for a wage, but differ in their 
assessment of the value of time lost that would be spent in 
nonmarket work (e.g., housework, yardwork, and raising children) and 
leisure (e.g., recreation, family time, and sleep). They also differ 
in their valuation of (other) disutility, which encompasses a range 
of factors of well-being, including both inconvenience and any pain 
and suffering. A complete discussion of the traditional and enhanced 
COI approaches can be found in Appendix E of the RTCR EA (USEPA 
2012a).
---------------------------------------------------------------------------

    As Exhibit VI-25 shows, approximately 2 deaths would need to be 
avoided from a Salmonella infection for the rule to break even. The 
estimated number of non-fatal Salmonella cases that would need to be 
avoided to break even is approximately 10,000 or 68,000 cases under the 
enhanced and traditional benefits valuations approaches, respectively. 
Given the large number of potential waterborne pathogens shown to occur 
in PWSs and the relatively low net costs of the RTCR, EPA believes, as 
discussed in this section and in the RTCR EA, that the RTCR is likely 
to at least break even. Chapter 9 of the RTCR EA has a complete 
discussion of the break-even analysis and how costs per case were 
calculated.

        Exhibit VI-25--Estimated Breakeven Threshold for Avoided Cases of E. coli O157:H7 and Salmonella
----------------------------------------------------------------------------------------------------------------
                                                               RTCR                     Alternative option
      Cost of illness (COI)        Discount rate ---------------------------------------------------------------
           methodology               (percent)       Non-fatal      Fatal cases      Non-fatal      Fatal cases
                                                    cases only       only \1\       cases only       only \1\
----------------------------------------------------------------------------------------------------------------
E. coli O157:H7
    Traditional COI.............               3           8,000             1.6          17,000             3.4
                                               7           8,000             1.6          18,000             3.6
    Enhanced COI................               3           3,000             1.6           6,000             3.4
                                               7           3,000             1.6           6,000             3.6
Salmonella

[[Page 10336]]

 
    Traditional COI.............               3          68,000             1.6         141,000             3.4
                                               7          68,000             1.6         151,000             3.6
    Enhanced COI................               3          10,000             1.6          21,000             3.4
                                               7          10,000             1.6          23,000             3.6
----------------------------------------------------------------------------------------------------------------
\1\ Calculations for fatal cases include the non-fatal COI component for the underlying illness prior to death.
Note: The number of cases needed to reach break-even threshold is calculated by dividing the net change in costs
  for the RTCR by the average estimated value of avoided cases.
E. coli O157:H7 and Salmonella are only two of multiple pathogenic endpoints that could have been used for this
  analysis. Use of additional pathogenic contaminants in addition to these single endpoints would result in
  lower threshold values.
Detail may not add due to independent rounding.
The breakeven threshold is higher using a 7% discount rate than a 3% discount rate under the Alternative option.
  This result is consistent with the costs of the Alternative option being higher using the 7% discount rate,
  which is caused by the frontloading of costs in the period of analysis, as explained further in Chapter 7 of
  the RTCR EA (USEPA 2012a).

    Cost-effectiveness is another way of examining the benefits and 
costs of the rule. Exhibit VI-26 shows the cost of the rule per 
corrective action implemented. 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 RTCR. As discussed previously 
and demonstrated in the RTCR EA, the RTCR achieves the lowest cost per 
corrective action avoided among the options considered. The incremental 
cost-effectiveness analysis shows that the RTCR has a lower cost per 
corrective action than the Alternative option.

    Exhibit VI-26--Total Net Annual Cost per Corrective Action Implemented Under RTCR and Alternative Option,
                        Annualized (Using Three Percent and Seven Percent Discount Rates)
                                               [$Millions, $2007]
----------------------------------------------------------------------------------------------------------------
                        Regulatory scenario                            3% discount rate       7% discount rate
----------------------------------------------------------------------------------------------------------------
RTCR--Net Change..................................................                 $14.3                  $14.2
RTCR--Incremental Number of Corrective Actions (L1 & L2)..........                 616                    594
RTCR--Cost Effectiveness Analysis.................................                  $0.02                  $0.02
Alternative Option--Net Change....................................                 $29.6                  $31.7
Alternative Option--Incremental Number of Corrective Actions (L1 &                 808                    819
 L2)..............................................................
Alternative Option--Cost Effectiveness Analysis...................                  $0.04                  $0.04
----------------------------------------------------------------------------------------------------------------
Note: Corrective actions include those conducted as a result of either Level 1 or Level 2 assessments. Total
  rule costs are shown in Exhibit 9.14 of the RTCR EA (USEPA 2012a). Detailed benefits and cost information is
  provided in Appendices A and C, respectively, of the RTCR EA (USEPA 2012a).

    The preferred option for the final rule is the RTCR. The analyses 
performed as part of the RTCR EA (USEPA 2012a) support the collective 
judgment and consensus of the advisory committee that the RTCR 
requirements provide for effective and efficient revisions to the 1989 
TCR regulatory requirements. The estimated net cost increase of the 
RTCR is small ($14M annually) relative to the 1989 TCR and small 
compared to the net cost increase of the Alternative option ($30M-$32M) 
relative to the 1989 TCR. In addition, no backsliding in overall risk 
is predicted.

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

    In the proposal for the RTCR, EPA requested comment on the SAB's 
concerns (selection of the RTCR option and measures for tracking long 
term effectiveness of RTCR), on replacement and maintenance costs for 
major distribution system appurtenances, on assumptions regarding State 
use of annual monitoring and annual site visits, and on assumptions 
regarding the results and effectiveness of Level 1 and Level 2 
assessments. This section summarizes the comments EPA received on these 
issues.
1. SAB's Concerns
    Most comments EPA received were in favor of the selection of the 
RTCR option over the 1989 TCR and the Alternative option. Commenters 
thought that the additional transition costs associated with the 
Alternative option did not justify the relatively small increase in 
benefits and noted that over the long term the benefits for both 
options were extremely similar. Some commenters provided EPA with 
specific input on what kind of data to collect in order to indicate the 
long term effectiveness of the RTCR. However, most commenters instead 
emphasized the need for SDWIS to be equipped to record the data, and 
that necessary changes to SDWIS be made in time for the rule to take 
effect. EPA remains committed to providing the necessary update to 
SDWIS before the final rule goes into effect and will continue to work 
with data users to identify system data collection needs and measures.
2. Costs of Major Distribution System Appurtenances
    Most comments supported EPA's decision not to include replacement 
or maintenance costs of major distribution system appurtenances under 
the RTCR. However, some commenters expressed concern that some systems, 
in particular small systems, do not plan for capital expenditures, and 
therefore these costs should be included. EPA continues to believe, as 
informed by the TCRDSAC deliberations, that the assessment requirement 
of the RTCR may help to identify when the useful life of an 
appurtenance has occurred or

[[Page 10337]]

maintenance is required, but that these costs should be attributable to 
regular maintenance and repair, not to the RTCR. Therefore, EPA has not 
changed this assumption in the EA for the final rule.
3. Annual Monitoring and Annual Site Visits
    Comments on this subject were mixed. Most commenters thought that 
the assumption that only states that currently allow annual monitoring 
and conduct annual site visits would continue to do so under the RTCR 
was a reasonable one. However, there were some commenters that pointed 
out that some States that currently do not allow annual monitoring may 
begin to allow it because of a lack of resources and because of the 
desire to meet only the minimum aspects of the RTCR. Based on 
stakeholder input and comments received, EPA continues to believe that 
EPA's original assumption is valid, that only States that currently 
allow annual monitoring and perform annual visits would continue to do 
so.
4. Effectiveness of Assessments
    Several commenters agreed that EPA made a reasonable assumption 
that 10 percent of assessments would lead to corrective action above 
what is occurring under the 1989 TCR. For those that did not agree the 
assumption was reasonable, the response was split between those that 
thought the estimate was too high, and those that thought the estimate 
was too low. Therefore, EPA has chosen to retain the estimate of 10 
percent, which was originally derived with stakeholder input.
    Several commenters supported the assumptions regarding the 
effectiveness of corrective actions. Many of these commenters stated 
that it would be extremely difficult to determine if these assumptions 
are accurate or not. Some commenters thought that these assumptions 
were too optimistic and that little or no benefit would be realized by 
the use of the assessments and corrective action. In the absence of 
strong consensus for changing these assumptions, EPA has elected to 
keep the assumptions in place.

O. Other Comments Received by EPA

    In addition to comments received as a result of requests for 
comment, EPA also received comments on various technical aspects of the 
EA. Those comments included concerns with the analysis in the following 
areas: EPA's inability to quantify health benefits, small PWS's 
possible inability to return to reduced monitoring after being 
triggered into monthly monitoring, the shift of State resources from 
public health related activities to tracking and compliance under the 
RTCR, and estimates about the State burden.
1. Quantifying Health Benefits
    Some commenters expressed concern that EPA is not quantifying 
benefits. Instead of quantifying the benefits, the RTCR EA examines the 
benefits in terms of trade-offs between compliance with the 1989 TCR 
and the other options considered (RTCR and Alternative option). As 
allowed under and consistent with the HRRCA requirements outlined in 
section 1412 (b)(3)(C) of the SDWA, EPA used several methods to 
qualitatively evaluate the benefits of the RTCR and Alternative option. 
The qualitative evaluation uses both the judgment of EPA as informed by 
the TCRDSAC deliberations as well as quantitative estimates of changes 
in total coliform occurrence and counts of systems implementing 
corrective actions. EPA acknowledges that the predicted benefits of 
changes in total coliform occurrence and numbers of corrective actions 
implemented are a function of model assumptions, and EPA recognizes 
that there is some uncertainty with the assumptions. However, 
sensitivity analyses showed that the fundamental conclusions of the EA 
do not change over a wide range of assumptions tested, and that the 
RTCR provides benefits over the 1989 TCR.
    EPA notes that the supporting analyses that formed the foundation 
of the RTCR EA were reviewed by the SAB. SAB noted in their report that 
``in general, the Committee was impressed by the work the Agency 
undertook. The Agency obviously did a great deal of work and put a 
significant amount of thought into making use of the limited amount of 
data.'' SAB also acknowledged that ``the EA represents the best 
possible analysis given the paucity of available data'' (SAB 2010).
2. Return to Reduced Monitoring
    Some commenters stated that PWSs, in particular NCWSs, will never 
again qualify for quarterly or annual monitoring under the RTCR once 
they are triggered into increased monthly monitoring. EPA disagrees 
with this statement. Under the RTCR, NCWSs that are triggered into 
monthly monitoring could possibly meet the criteria to once again 
qualify for (routine) quarterly or (reduced) annual monitoring in as 
little as one year. Some commenters stated that EPA has underestimated 
the numbers of systems that will be triggered into monthly monitoring 
based on existing noncompliance rates, with particular emphasis on 
systems with monitoring violations.
    Consistent with past EPA EA analyses, the occurrence model and cost 
estimates in the EA do not include estimates for non-compliance with 
EPA regulatory requirements such as monitoring. In addition, EPA 
disagrees with many commenters' assumptions that monitoring violation 
rates will remain the same under the RTCR. EPA believes that the rates 
of monitoring violations will decrease because of strengthened 
incentives for systems to monitor and the enhanced consequences of 
noncompliance. A PWS on quarterly or annual monitoring has a greater 
incentive under the RTCR to do its monitoring because if it doesn't, it 
will be triggered into increased monitoring. The 1989 TCR did not 
include such a requirement. Under the RTCR, if a PWS does not complete 
its repeat samples, it will be triggered to conduct an assessment. With 
greater consequences for not completing required sampling, systems will 
be more likely to complete their monitoring. Thus, EPA believes that 
rates of monitoring and reporting violations will be lower under the 
RTCR than they are under the 1989 TCR.
    Many commenters had concerns with monitoring violation rates 
specifically for those systems that are on annual monitoring. EPA 
believes that the monitoring violation rates for these systems will not 
be as high as predicted by commenters since one of the requirements to 
remain on annual monitoring is an annual site visit by the State or a 
Level 2 assessment. If, at the time of the site visit or the Level 2 
assessment, that year's annual samples have not been taken, the State 
or assessor will have the opportunity to remind the system to take the 
required samples, assist the system in taking the sample at that time, 
or include taking the sample as part of the site visit or assessment.
    All triggers to increased monitoring in the RTCR are consistent 
with EPA's position, as informed by TCRDSAC discussions, that annual 
monitoring is a privilege for only the most well run systems. Systems 
that are not able to meet annual monitoring requirements would not be 
considered among the most well run, and therefore would be triggered 
into more frequent monitoring.
3. Shift of State Resources
    Some commenters assert that States will be overwhelmed by the 
burden of tracking and enforcement activities of RTCR because all small 
PWSs, especially NCWSs, will be triggered into monthly monitoring under 
the RTCR

[[Page 10338]]

and that this will result in a significant increase in violations and 
tracking and enforcement activities.
    In order to address these concerns, EPA made a change from the 
proposal to this final rule by changing the result of a monitoring 
violation trigger for systems on annual monitoring. Instead of a 
monitoring violation triggering a system directly into monthly 
monitoring, a monitoring violation will now trigger the system in 
violation to quarterly monitoring. All other triggers (i.e., E. coli 
MCL violation, a Level 2 assessment, a coliform treatment technique 
violation) continue to move the system to monthly monitoring. This was 
done to address concerns that too many systems would end up on monthly 
monitoring and it would be too burdensome for both systems and States. 
This change did not affect any cost numbers in the EA since the EA does 
not model non-compliance. See sections III.C.1.b.iv, Increased 
monitoring, and III.C.2.b, Ground water NCWSs serving primacy agencies and EPA to determine appropriate requirements 
for specific systems and evaluate compliance with the proposed RTCR. 
Burden is defined at 5 CFR 1320.3(b) and means the total time, effort, 
and financial resources required to generate, maintain, retain, 
disclose, or provide information to or for a Federal agency. The burden 
for this final rule includes the time needed to conduct the following 
State and PWS activities:
    State activities:
     Read and understand the rule;
     Mobilize (including primacy application), plan, and 
implement;
     Train PWS and consultant staff;
     Track compliance;
     Analyze and review PWS data;
     Review sample siting plans and recommend any revisions to 
PWSs;
     Make determinations concerning PWS monitoring 
requirements;
     Respond to PWSs that have positive samples;
     Recordkeeping;
     Review completed assessment forms and consult with the PWS 
about the assessment report;
     Review and coordinate with PWSs to determine optimal 
corrective actions to be implemented; and
     Provide consultation, review PN certifications, and file 
reports of violations.
    PWS activities:
     Read and understand the rule;
     Planning and mobilization activities;
     Revise existing sample siting plans to identify sampling 
locations and collection schedules that are representative of water 
throughout the distribution system;
     Conduct routine, additional routine, and repeat 
monitoring, and report the results as required;
     Complete a Level 1 assessment if the PWS experiences a 
Level 1 trigger, and submit a form to the State to identify sanitary 
defects detected, corrective actions completed, and a timetable for any 
corrective actions not already completed;
     Complete a Level 2 assessment if the PWS experiences a 
Level 2 trigger, and submit a form to the State to identify sanitary 
defects detected, corrective actions completed, and a timetable for any 
corrective actions not already completed;
     Correct sanitary defects found through the performance of 
Level 1 or

[[Page 10339]]

Level 2 assessments and report on completion of corrective actions as 
required;
     Develop and distribute Tier 1 public notices when E. coli 
MCL violations occur;
     Develop and distribute Tier 2 public notices when the PWSs 
fail to take corrective action; and
     Develop and distribute Tier 3 public notices when the PWSs 
fail to comply with the monitoring requirements or with mandatory 
reporting of required information within the specified timeframe.
    For the first three years after publication of the RTCR in the FR, 
the major information requirements apply to 154,894 respondents. The 
total incremental burden associated with the change in moving from the 
information requirements of the 1989 TCR to those in the RTCR over the 
three years covered by the ICR is 2,518,578 hours, for an average of 
839,526 hours per year. The total incremental cost over the three-year 
clearance period is $71.3M, for an average of $23.8M per year (simple 
average over three years). (Note that this is higher than the 
annualized costs for the RTCR because in the EA, the up-front costs 
that occur in the first three years, as well as future costs, are 
annualized over a 25-year time horizon.) The average burden per 
response (i.e., the amount of time needed for each activity that 
requires a collection of information) is 5.4 hours; the average cost 
per response is $153. The collection requirements are mandatory under 
SDWA section 1445(a)(1). Detail on the calculation of the RTCR's 
information collection burden and costs can be found in the ICR for the 
Revised Total Coliform Rule (USEPA 2012c) and chapter 8 of the EA 
(USEPA 2012a). A summary of the burden and costs of the collection is 
presented in Exhibit VII-1.

                                       Exhibit VII-1--Average Annual Net Change Burden and Costs for the RTCR ICR
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                       Cost
                                                                         ----------------------------------------------------------------
                                                           Annual burden                      Annual                                          Annual
                     Respondent type                           hours       Annual labor     operation &   Annual capital   Total annual      responses
                                                                               cost         maintenance        cost            cost
                                                                                            (O&M) cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
PWSs....................................................         747,848     $20,171,639  ..............  ..............     $20,171,639         103,225
States and Territories..................................          91,678       3,595,421  ..............  ..............       3,595,421          51,669
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................         839,526      23,767,060  ..............  ..............      23,767,060         154,894
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: Detail may not add exactly to total due to independent rounding.
``Annual Burden Hours'' reflects an annual average for all system sizes over the 3-year ICR period.
Source: ICR for the Revised Total Coliform Rule (USEPA 2012c).

    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in 40 CFR are listed in 40 CFR part 9. When this ICR is 
approved by OMB, the Agency will publish a technical amendment to 40 
CFR part 9 in the FR to display the OMB control number for the approved 
information collection requirements contained in this final rule.

C. Regulatory Flexibility Act (RFA)

    The Regulatory Flexibility Act (RFA) generally requires an agency 
to prepare a regulatory flexibility analysis of any rule subject to 
notice and comment rulemaking requirements under the Administrative 
Procedure Act or any other statute unless the agency certifies that the 
rule will not have a significant economic impact on a substantial 
number of small entities. Small entities include small businesses, 
small organizations, and small governmental jurisdictions.
    The RFA provides default definitions for each type of small entity. 
Small entities are defined as: (1) A small business as defined by the 
Small Business Administration's (SBA) regulations at 13 CFR 121.201; 
(2) a small governmental jurisdiction that is a government of a city, 
county, town, school district or special district with a population of 
less than 50,000; and (3) a small organization that is any ``not-for-
profit enterprise which is independently owned and operated and is not 
dominant in its field.'' However, the RFA also authorizes an agency to 
use alternative definitions for each category of small entity, ``which 
are appropriate to the activities of the agency'' after proposing the 
alternative definition(s) in the FR 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 RTCR on small 
entities, EPA considered small entities to be PWSs serving 10,000 or 
fewer people. This is the cut-off level specified by Congress in the 
1996 Amendments to the SDWA for small system flexibility provisions. As 
required by the RFA, EPA proposed using this alternative definition in 
the FR (63 FR 7620, February 13, 1998), requested public comment, 
consulted with the SBA, and finalized the alternative definition in the 
Agency's CCR regulation (63 FR 44524, August 19, 1998). As stated in 
that Final Rule, the alternative definition would be applied for all 
future drinking water regulations.
    After considering the economic impacts of the RTCR on small 
entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. The small 
entities directly regulated by this rule are small PWSs serving 10,000 
or fewer people. These include small CWSs, NTNCWSs, and TNCWSs, 
entities such as municipal water systems (publicly and privately 
owned), and privately-owned PWSs and for-profit businesses where 
provision of water may be ancillary, such as mobile home parks, day 
care centers, churches, schools and homeowner associations. We have 
determined that only 61 of 150,672 small systems (0.04%) will 
experience an impact of more than 1% of revenues, and that none of the 
small systems will experience an impact of 3% or greater of revenue. 
This information is described further in chapter 8 of the RTCR EA.
    Although this final rule will not have a significant economic 
impact on a substantial number of small entities, EPA nonetheless has 
tried to reduce the impact of this rule on small PWSs. Provisions in 
the RTCR that result in

[[Page 10340]]

reduced costs for many small entities include:
     Reduced routine monitoring for qualifying PWSs serving 
1,000 or fewer people.
     Reduced number of repeat samples required for systems 
serving 1,000 or fewer people.
     Reduced additional routine monitoring for PWSs serving 
4,100 or fewer people.
     Reduced PN requirements for all systems, including small 
systems.
    EPA also conducted outreach to small entities and convened a Small 
Business Advocacy Review Panel to obtain advice and recommendations of 
representatives of the small entities that potentially would be subject 
to this rule's requirements. For a description of the Small Business 
Advocacy Review Panel and stakeholder recommendations, please see 
section VII.C of the preamble to the proposed RTCR, Regulatory 
Flexibility Act (RFA).

D. Unfunded Mandates Reform Act (UMRA)

    This rule does not contain a Federal mandate under the provisions 
of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 
U.S.C. 1531-1538 that may result in expenditures to State, local, and 
Tribal governments, in the aggregate, or to the private sector, of 
$100M or more in any one year. Expenditures associated with compliance, 
defined as the incremental costs beyond the 1989 TCR, will not surpass 
$100M in the aggregate in any year. Thus, this rule is not subject to 
the requirements of sections 202 and 205 of UMRA.
    The RTCR is also not subject to the requirements of section 203 of 
UMRA because it contains no regulatory requirements that might 
significantly or uniquely affect small governments. Costs to small 
entities are generally not significant, as described previously in 
section VII.C of this preamble, Regulatory Flexibility Act (RFA), and 
are detailed in the RTCR EA. The regulatory requirements of the final 
RTCR are not unique to small governments, as they apply to all PWSs 
regardless of size.

E. Executive Order 13132: Federalism

    This action does not have Federalism implications. It will not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the 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 $0.2M and $0.4M at three percent and seven percent 
discount rates, respectively. Thus, Executive Order 13132 does not 
apply to this final rule.
    Although section 6 of Executive Order 13132 does not apply to the 
RTCR, EPA conducted a Federalism Consultation, consistent with 
Executive Order 13132, in July 2008. The consultation included a 
stakeholder meeting where EPA requested comments on the impacts of the 
potential revisions to the 1989 TCR with respect to State, county and 
local governments. EPA did not receive any comments in response to this 
consultation. In addition, the advisory committee included 
representatives of State, local and Tribal governments, and through 
this process EPA consulted with State, local, and Tribal government 
representatives to ensure that their views were considered when the AIP 
recommendations for the proposed RTCR were developed. EPA also included 
representatives from four states on its workgroup for developing the 
proposed RTCR.
    In the spirit of Executive Order 13132 and consistent with EPA 
policy to promote communications between EPA and State and local 
governments, EPA specifically solicited comment on the proposed action 
from State and local officials. Some States were concerned with the 
burden of implementing the rule, especially those States that have a 
high proportion of NCWSs. Under this rule, expenditures for assessments 
and corrective actions and increased monitoring are targeted to the 
fraction of PWSs that are most vulnerable to pathways for contamination 
of the distribution system, thereby minimizing the burden for the 
majority of PWSs and for States implementing the rule. As described in 
sections III.E.2, Assessment, and III.C.1.b.iv, Increased monitoring, 
of this preamble, EPA is also providing flexibility on how the PWSs and 
States conduct and track assessments, and by changing the consequence 
for systems on annual monitoring that have RTCR monitoring violations 
(i.e., increase to quarterly monitoring instead of monthly monitoring). 
EPA also has plans to update SDWIS to maximize its efficiency in 
support of rule implementation. These actions should address many of 
the State concerns about burden.

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

    This action does not have tribal implications, as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000). EPA consulted 
with Tribes throughout the development of the RTCR (as described in 
this section) and no issues that were particular to Tribal entities 
were identified.
    Although Executive Order 13175 does not apply to this action, EPA 
consulted with Tribal officials in developing this action. EPA 
consulted with Tribal governments through the EPA American Indian 
Environmental Office; included a representative of the Native American 
Water Association on the advisory committee who helped develop and 
signed the AIP on recommendations on the proposed rule; and addressed 
Tribal concerns throughout the regulatory development process, as 
appropriate. The consultation included participation in three Tribal 
conference calls (EPA regional Tribal call (February 2008), National 
Indian Workgroup call (March 2008), and National Tribal Water 
Conference (March 2008)). EPA requested comments on the 1989 TCR, 
requested suggestions for 1989 TCR revisions (March 2008), and 
presented possible revisions to the 1989 TCR to the National Tribal 
Council (April 2008). In addition, the advisory committee included a 
representative from the Native American Water Association who 
represented Tribal entities, and through this process EPA ensured that 
Tribal views were considered when the AIP recommendations for the 
proposed RTCR were developed. None of these consultations identified 
issues that were particular to Tribal entities. EPA also specifically 
solicited additional comment on the proposed rule from Tribal 
officials, and no additional issues were identified. As a result of the 
Tribal consultations and other Tribal outreach, EPA has determined that 
the RTCR is not anticipated to have a negative impact on Tribal 
systems. Thus, Executive Order 13175 does not apply to this action.

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

    The RTCR is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997) because it is not economically significant as defined 
in Executive Order 12866, and because the Agency does not believe the 
environmental health or safety risks addressed by this action present a 
disproportionate risk to children. This action's health and risk 
assessments regarding children are contained in section VI.K.1 of this 
preamble, Risk to children, pregnant women, and the elderly, and in the 
RTCR EA. EPA expects that the RTCR would provide additional protection 
to

[[Page 10341]]

both children and adults who consume drinking water supplied from PWSs. 
EPA also believes the benefits of this rule, including reduced health 
risk, accrue more to children because young children are more 
susceptible than adults to some waterborne illnesses. For example, the 
risk of mortality resulting from diarrhea is often greatest in the very 
young and elderly (Rose 1997; Gerba et al. 1996), and viral and 
bacterial illnesses often disproportionately affect children. Any 
overall benefits of the rule would reduce this mortality risk for 
children.

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

    This rule is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not 
likely to have a significant adverse effect on the supply, 
distribution, or use of energy. Additionally, none of the requirements 
of this rule involve the installation of treatment or other components 
that use a measurable amount of energy.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, 12(d) (15 U.S.C. 272 note), 
directs EPA to use voluntary consensus standards in its regulatory 
activities unless to do so would be inconsistent with applicable law or 
otherwise impractical. Voluntary consensus standards are technical 
standards (e.g., materials specifications, test methods, sampling 
procedures, and business practices) that are developed or adopted by 
voluntary consensus standards bodies. NTTAA directs EPA to provide 
Congress, through OMB, explanations when EPA decides not to use 
available and applicable voluntary consensus standards.
    This rule involves technical voluntary consensus standards. As in 
the 1989 TCR, under the provisions of the RTCR water systems are 
required to use several analytical methods to monitor for total 
coliforms and/or E. coli as they are described in Standard Methods for 
the Examination of Water and Wastewater, 20th and 21st editions 
(Clesceri et al. 1998; Eaton et al. 2005). Methods included in Standard 
Methods are voluntary consensus standards. The 1989 TCR and RTCR 
include the same 11 methods that can be used to test for total 
coliforms. Four of the 11 are voluntary consensus methods described in 
Standard Methods.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes 
federal executive policy on environmental justice. Its main provision 
directs federal agencies, to the greatest extent practicable and 
permitted by law, to make environmental justice part of their mission. 
Agencies 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 U.S.
    EPA has determined that this action will not have 
disproportionately high and adverse human health or environmental 
effects on minority or low-income populations because it increases the 
level of environmental protection for all affected populations without 
having any disproportionately high and adverse human health or 
environmental effects on any population, including any minority or low-
income population. The RTCR applies uniformly to all PWSs and 
consequently provides health protection equally to all income and 
minority groups served by PWSs. The RTCR and other drinking water 
regulations are expected to have a positive effect on human health 
regardless of the social or economic status of a specific population. 
To the extent that contaminants in drinking water might be 
disproportionately high among minority or low-income populations (which 
is unknown), the RTCR contributes toward removing those differences by 
assuring that all public water systems meet drinking water standards 
and take appropriate corrective action whenever appropriate. Thus, the 
RTCR meets the intent of the Federal policy requiring incorporation of 
environmental justice into Federal agency missions.

K. Consultations With the Science Advisory Board, National Drinking 
Water Advisory Council, and the Secretary of Health and Human Services

    In accordance with section 1412(d) and (e) of the SDWA, EPA 
consulted with the SAB, the NDWAC, and the Secretary of the US 
Department of Health and Human Services on the RTCR.
    EPA met with the Drinking Water Committee (DWC) of the SAB to 
discuss the proposed RTCR on May 20, 2009 (teleconference) and June 9 
and 10, 2009 (Washington, DC). The SAB 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 US; (2) the occurrence analysis used to inform the benefits 
analysis; (3) the qualitative analysis used to assess the reduction in 
risk due to implementation of the rule requirements; and (4) analysis 
of the engineering costs and costs to States resulting from 
implementation of the revisions.
    Overall, the SAB DWC supported EPA's analysis. SAB members 
commended EPA for making use of the best available data to assess the 
impacts of the proposed rule. The SAB DWC supported the decision by EPA 
not to quantify public health benefits, acknowledging that EPA had 
insufficient data to do so. However, they noted in their analysis of 
the EA that they are not generally supportive of decreased monitoring, 
and that overall, the Alternative option appears to address and protect 
public health sooner in time than the AIP proposed implementation. The 
SAB DWC recommended that EPA clarify rationales for assumptions; expand 
explanations of sensitivity analyses that were included; provide 
further justification in those areas in which sensitivity analyses were 
not conducted; and collect data after promulgation of the rule to allow 
EPA to better understand the public health impacts of the RTCR.
    In response to the SAB DWC recommendations, EPA conducted 
sensitivity analyses to explore a wider range of assumptions regarding 
the percentage of assessments leading to corrective actions and to 
demonstrate that using an annual average for occurrence provided 
results comparable to varying the occurrence based on the season. EPA 
also added an exhibit in the EA that summarizes all significant model 
parameters and assumptions, their influence on variability and 
uncertainty, and their most likely effect on benefits or costs. The 
added exhibits and expanded and clarified text can be found in the RTCR 
EA. A copy of the SAB report (SAB 2010) is available in the docket for 
this rule.
    EPA consulted with NDWAC on May 28, 2009, in Seattle, Washington, 
to discuss the proposed RTCR. NDWAC members expressed concern that a 
rule based on the AIP sounds complicated and recommended that EPA 
provide the utilities and States with tools to help them understand the 
revised rule provisions and to assist with providing public education. 
In response to

[[Page 10342]]

NDWAC's concern, EPA requested comment on whether the proposed RTCR 
would result in requirements that would be easier to implement compared 
to the 1989 TCR.
    EPA heard from commenters that the RTCR will be difficult to 
implement in States that have a lot of small NCWSs, especially the 
reduced and increased monitoring provisions. To address this concern, 
EPA provided flexibility to States to help them implement, and to PWSs 
to help them comply, with the monitoring provisions of the RTCR. States 
are given the flexibility to not count monitoring violations towards 
eligibility for a TNCWS to remain on quarterly monitoring or to return 
to quarterly monitoring as long as the system collects the make-up 
sample by the end of the next monitoring period. EPA also changed the 
consequence of having one RTCR monitoring violation for systems on 
annual monitoring. Instead of having to go to monthly monitoring, the 
system now moves to quarterly monitoring. See section III.C.2.b of this 
preamble, Ground water NCWSs serving 
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 RTCR will help 
reduce pathways of entry for fecal contamination and/or waterborne 
pathogens into the distribution system, thereby reducing exposure and 
risk from these contaminants in drinking water to the entire general 
population. The RTCR seeks to provide a similar level of drinking water 
protection to all groups including sensitive subpopulations, thus 
meeting the intent of this Federal policy. See also section VI.K of 
this preamble, Effects of Fecal Contamination and/or Waterborne 
Pathogens on the General Population and Sensitive Subpopulations, for a 
more detailed discussion of this topic.

M. Effect of Compliance With the RTCR on the Technical, Financial, and 
Managerial Capacity of Public Water Systems

    Section 1420(d)(3) of the SDWA, as amended, requires that, in 
promulgating an NPDWR, the Administrator shall include an analysis of 
the likely effect of compliance with the regulation on the technical, 
managerial, and financial (TMF) capacity of PWSs. The following 
analysis fulfills this statutory obligation by identifying the 
incremental impact that the RTCR will have on the TMF capacity of 
regulated water systems. Analyses presented in this document reflect 
only the impact of new or revised requirements, as established by the 
RTCR; the impacts of previously established requirements on system 
capacity are not considered.
    EPA has defined overall water system capacity as the ability to 
plan for, achieve, and maintain compliance with applicable drinking 
water standards. Capacity encompasses three components: technical, 
managerial, and financial. Technical capacity is the physical and 
operational ability of a water system to meet SDWA requirements. This 
refers to the physical infrastructure of the water system,

[[Page 10343]]

including the adequacy of source water and the adequacy of treatment, 
storage, and distribution infrastructure. It also refers to the ability 
of system personnel to adequately operate and maintain the system and 
to otherwise implement requisite technical knowledge. Managerial 
capacity is the ability of a water system to conduct its affairs to 
achieve and maintain compliance with SDWA requirements. Managerial 
capacity refers to the system's institutional and administrative 
capabilities. Financial capacity is a water system's ability to acquire 
and manage sufficient financial resources to allow the system to 
achieve and maintain compliance with SDWA requirements. Technical, 
managerial, and financial capacity can be assessed through key issues 
and questions, including the following:

------------------------------------------------------------------------
 
------------------------------------------------------------------------
                           Technical Capacity
------------------------------------------------------------------------
Source water adequacy..................  Does the system have a reliable
                                          source of water with adequate
                                          quantity? Is the source
                                          generally of good quality and
                                          adequately protected?
Infrastructure adequacy................  Can the system provide water
                                          that meets SDWA standards?
                                          What is the condition of its
                                          infrastructure, including
                                          wells or source water intakes,
                                          treatment and storage
                                          facilities, and distribution
                                          systems? What is the
                                          infrastructure's life
                                          expectancy? Does the system
                                          have a capital improvement
                                          plan?
Technical knowledge and implementation.  Are the system's operators
                                          certified? Do the operators
                                          have sufficient knowledge of
                                          applicable standards? Can the
                                          operators effectively
                                          implement this technical
                                          knowledge? Do the operators
                                          understand the system's
                                          technical and operational
                                          characteristics? Does the
                                          system have an effective O&M
                                          program?
------------------------------------------------------------------------
                           Managerial Capacity
------------------------------------------------------------------------
Ownership accountability...............  Are the owners clearly
                                          identified? Can they be held
                                          accountable for the system?
Staffing and organization..............  Are the operators and managers
                                          clearly identified? Is the
                                          system properly organized and
                                          staffed? Do personnel
                                          understand the management
                                          aspects of regulatory
                                          requirements and system
                                          operations? Do they have
                                          adequate expertise to manage
                                          water system operations (i.e.,
                                          to conduct implementation,
                                          monitor for E. coli)? Do
                                          personnel have the necessary
                                          licenses and certifications?
Effective external linkages............  Does the system interact well
                                          with customers, regulators,
                                          and other entities? Is the
                                          system aware of available
                                          external resources, such as
                                          technical and financial
                                          assistance?
------------------------------------------------------------------------
                           Financial Capacity
------------------------------------------------------------------------
Revenue sufficiency....................  Do revenues cover costs?
Creditworthiness.......................  Is the system financially
                                          healthy? Does it have access
                                          to capital through public or
                                          private sources?
Fiscal management and controls.........  Are adequate books and records
                                          maintained? Are appropriate
                                          budgeting, accounting, and
                                          financial planning methods
                                          used? Does the system manage
                                          its revenues effectively?
------------------------------------------------------------------------

    EPA looked at the major requirements of the RTCR that may affect 
the TMF capacity of PWSs. These requirements include: sample siting 
plan revision, monitoring, assessments, corrective actions, and PNs. 
Another factor that may affect the TMF capacity is the need for PWS 
personnel to familiarize themselves with the RTCR requirements. EPA 
developed a scoring system to analyze the impact of complying with 
these requirements on the TMF capacity of PWSs. A detailed discussion 
of EPA's analysis is presented in chapter 8.14 of the RTCR EA (USEPA 
2012a).
    The RTCR will apply to all PWSs and may affect 51,972 CWSs, 18,729 
NTNCWSs, and 84,136 TNCWSs--154,837 systems in all. While some systems 
may require increased TMF capacity to comply with the new RTCR 
requirements, or will need to tailor their compliance approaches to 
match their capacities, most systems will not.
    Small systems will likely face only a small challenge to their 
technical and managerial capacity as a result of efforts to familiarize 
themselves with the monitoring requirements of the RTCR. Routine and 
repeat monitoring requirements under the RTCR are essentially the same 
as under the 1989 TCR, with more explicit criteria to qualify for 
reduced monitoring. Therefore, understanding the RTCR monitoring 
requirements is not expected to pose many new technical or managerial 
capacity issues for small systems.
    Small system technical and managerial capacity may be affected by 
the assessment requirements of the RTCR. Performing assessments may 
require the system to increase staffing levels in addition to providing 
training to ensure that system staff understand how those assessments 
are to be performed. Reporting, record-keeping, and data administration 
requirements will also affect the managerial capacity of small systems.
    Small systems that are required to take corrective action are 
expected to experience the most significant financial challenge since 
some corrective actions may consist of a large, one-time capital 
expenditure to resolve the problem.
    Large systems will likely not face any significant challenge to 
their technical and managerial capacity as a result of efforts to 
familiarize themselves with the RTCR. Most large systems are familiar 
with the 1989 TCR and there are no changes in the basic monitoring 
requirements for large systems under the RTCR. They are therefore 
assumed to already have the TMF capacity in place for the RTCR.
    Only large systems performing assessments and corrective actions 
would be expected to face a significant challenge meeting the TMF 
capacity requirements. However, this requirement is only necessary when 
monitoring reveals potential problems, and this is not expected to 
occur significantly in large systems above that experienced under the 
1989 TCR. Many large systems already have the TMF capacity to conduct 
assessments and

[[Page 10344]]

corrective actions if they are needed. These systems will be affected 
less significantly than smaller systems that have to implement 
corrective actions because it is recognized that they are typically 
already implementing similar assessments and corrective actions when a 
routine monitoring sample tests positive for fecal indicators under the 
1989 TCR.

N. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the US. 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the US prior to publication of the rule in 
the FR. A Major rule cannot take effect until 60 days after it is 
published in the FR. This action is not a ``major rule'' as defined by 
5 U.S.C. 804(2). This rule will be effective April 15, 2013.

VIII. References

American Water Works Association (AWWA). 2010. Comment submitted on 
the Proposed Revised Total Coliform Rule. www.regulations.gov. 
Docket ID EPA-HQ-OW-2008-0878-0199.
Bennett, J. V., S.D. Holmberg, M.F. Rogers, and S.L. Solomon. 1987. 
Infectious and Parasitic Diseases. Closing the Gap: The Burden of 
Unnecessary Illness. Eds. R.W. Amler & H.B Dull. Oxford University 
Press, New York. 102-114.
Berlin, L.E., M.L. Rorabaugh, F. Heldrich, K. Roberts, T. Doran, and 
J.F. Modlin. 1993. Aseptic meningitis in infants http://www.cdc.gov/mmwR/preview/mmwrhtml/00045949.htm. Accessed July 2009.
CDC. 2007. ``List of Vaccine-Preventable Diseases.'' http://www.cdc.gov/vaccines//vpd-vac/vpd-list.htm. June 13, 2007. Accessed 
July 2009.
Cherry, J.D. 1995. Enteroviruses. In: Infectious Diseases of the 
Fetus and Newborn Infant, 4th ed. Remington and Klein, eds. 
Philadelphia, WB Saunders Company. pp. 404-446.
Clark, W. F., J.J. Mcnab, and J. M. Sontrop. 2008. The Walkerton 
Health Study, 2002-2008, Final Report Submitted to the Ontario 
Ministry of Health and Long-Term Care. 76 pp. (includes list of peer 
reviewed publications).
Clark, W. F., J.M. Sontrop, J.J. Macnab, M. Salvadori, L. Moist, R. 
Suri, and A. X. Garg. 2010. Long term risk for hypertension, renal 
impairment, and cardiovascular disease after gastroenteritis from 
drink water contaminated with Escherichia coli O157:H7: a 
prospective cohort study. British Medical Journal 2010;341:c6020 
doi:10.1136/bmj.c6020.
Clesceri, L.S., A.E. Greenberg, and A.D. Eaton, eds. 1998. Standard 
Methods for the Examination of Water and Wastewater, 20th ed. 
Washington, DC. American Public Health Association.
Cooley, M., D. Carychao, L. Crawford-Miksza, M.T. Jay, C. Myers, C. 
Rose, C. Keys, J. Farrar, and R.E. Mandrell. 2007. Incidence and 
tracking of Escherichia coli O157:H7 in a major produce production 
region in California. PLoS ONE. November 2007. 14;2(11):e1159. 
doi:10.1371/journal.pone.0001159.
Craun, G.F. 1996. Cases of illness required to initiate a waterborne 
outbreak investigation. Unpublished report to SAIC. September 18, 
1996. 38 pp.
Craun, G.F., R.L. Calderon and T.J. Wade, 2006. Assessing waterborne 
risks: an introduction. Journal of Water and Health 4(2):3-18.
Dalldorf, G., and J.L. Melnick. 1965. Coxsackie Viruses. In: Viral 
and Rickettsial Infections of Man. 4th ed. F.L. Horsefall and L. 
Tamms. eds. Philadelphia, J.B. Lippincott. pp. 474-511.
Dennehy, P.H. 2008. Rotavirus vaccines: an overview. Clinical 
Microbiology Reviews 21(1):198-208.
Eaton, A.D., L.S. Clesceri, E.W. Rice, and A.E. Greenberg, eds. 
2005. Standard Methods for the Examination of Water and Wastewater, 
21st ed. Washington, DC. American Public Health Association.
Edberg, S.C., E.W. Rice, R.J. Karlin and M. J. Allen. 2000. 
Escherichia coli: the best biological drinking water indicator for 
public health protection. Journal of Applied Microbiology 88:106S-
116S.
Farthing, M.J. 2000. Clinical Aspects of Human Cryptosporidiosis. 
In: Cryptosporidiosis and Microsporidiosis. vol. 6. 1st ed. F. 
Petry, ed. New York. S. Kargar. pp. 50-74.
Feng, P. 1995. Escherichia coli Serotype O157:H7: Novel Vehicles of 
Infection and Emergence of Phenotypic Variants, Emerging Infectious 
Diseases. 1(2):47-52.
Fricker, C., P. Warden, D. Silvaggio, E. Gleeseman, R. Tamanaha, J. 
Rust, B. Eldred. 2003. Comparison of Five Commercially Available 
Methods for Detection of Coliform and E. coli. AWWA Water Quality 
and Technology Conference. Philadelphia, PA. November 2003.
Frisby, H.R., D.G. Addiss, W.J. Reiser, B. Hancock, J.M. Vergeront, 
N.J. Hoxie, J.P. Davis. 1997. Clinical and epidemiologic features of 
a massive waterborne outbreak of cryptosporidiosis in persons with 
HIV infection. J. AIDS and Hum. Retrovirology 16:367-373.
Garg, A.X., R.S. Suri, N. Barrowman, F. Rehman, D. Matsell, M. P. 
Rosas-Arellano, M. Salvadori, R. B. Haynes, W.F. Clark. 2003. Long-
term Renal Prognosis of Diarrhea-Associated Hemolytic Uremic 
Syndrome, A Systematic Review, Meta-analysis, and Meta-regression. 
Journal American Medical Association. 290(10):1360-1370.
Gerba, C. P., J. B. Rose, and C. N. Haas. 1996. Sensitive 
Populations: who is at the greatest risk? Int. J. Food Micro. 
30:113-123.
Glass, R.I., J. Noel, T. Ando, R. Fankhauser, G. Belliot, A. Mounts, 
U.D. Parashar, J.S. Bresee, and S.S. Monroe. 2000. The Epidemiology 
of Enteric Caliciviruses from Humans: A Reassessment Using New 
Diagnostics. Journal of Infectious Diseases. 181(Suppl 2):S254-61.
Gould, L.H., L. Demma, T.F. Jones, S. Hurd, D.J. Vugia, K. Smith, B. 
Shiferaw, S. Segler, A. Palmer, S. Zensky, P.M. Griffin, and the 
Emerging Infections Program FoodNet Working Group. 2009. Hemolytic 
Uremic Syndrome and Death in Persons with Escherichia coli O157:H7 
Infection, Foodborne Diseases Active Surveillance Network Sites, 
2000-2006. Clincal Infectious Diseases. 49:1480-1485. DOI: 10.1086/
644621.
Griffin, P.M. and R.V. Tauxe, 1991. The Epidemiology of Infections 
Caused by Escherichia coli O157:H7, Other Enterohemorrhagic E. coli, 
and the Associated Hemolytic Uremic Syndrome. Epidemiologic Reviews 
13:60-98.
Health Canada. 2000. Waterborne Outbreak of Gastroenteritis 
Associated with a Contaminated Municipal Water Supply, Walkerton, 
Ontario, May-June 2000. Canada Communicable Disease Report. October 
15, 2000. Volume 26-20. pp. 170-173.
Helmi, K., S. Skraber, C. Gantzer, R. Willame, L. Hoffmann, and H.M. 
Cauchie. 2008. Interactions of Cryptosporidium parvum, Giardia 
lamblia, Vaccinal Poliovirus Type 1, and Bacteriophages phiX174 and 
MS2 with a Drinking Water Biofilm and a Wastewater Biofilm. Applied 
and Environmental Microbiology. 74(7):2079-2088.
Hopkins, R.S., P.M. Shillam, B. Gaspard, L. Eisnach, and R.J. 
Karlin. 1985. Waterborne Disease in Colorado: Three Years' 
Surveillance and 18 Outbreaks. Amer. Jour. Public Health. 73(3):254-
257.
Hussein, H.S., 2007. Prevalence and pathogenicity of Shiga toxin-
producing Escherichia coli in beef cattle and their products. 
Journal of Animal Science. 85 (E. Suppl.):E63-E72.

[[Page 10345]]

Kaper, J.B, J.P. Nataro, H.L.T. Mobley, 2004. Pathogenic Escherichia 
coli. Nature Reviews Microbiology 2:123-140.
Kramer, M.H., B.L. Herwaldt, G.F. Craun, R.L. Calderon, and D.D. 
Juranek, D.D. 1996. Waterborne disease: 1993-1994. Journal AWWA. 
March 1996. pp. 66-80.
L[aring]ngmark, J., M.V. Storey, N.J. Ashbolt, and T.A. 
Stenstr[ouml]m. 2007. The effects of UV disinfection on distribution 
pipe biofilm growth and pathogen incidence within the greater 
Stockholm area, Sweden. Water Research 41: 3327-3336.
Lieberman, R.J., Shadix, L.C., Newport, B.S., Crout, S.R., Buescher, 
SE., Safferman, R.S., Stetler, R.E., Lye, D., Fout, G.S., and 
Dahling, D. 1994. Source water microbial quality of some vulnerable 
public ground water supplies. In: Proceedings, Water Quality 
Technology Conference. San Francisco, CA. October, 1994.
Lieberman, R., L. Shadix, B. Newport, and C. Frebis. 2002. Microbial 
Monitoring of Vulnerable Public Groundwater Supplies. American Water 
Works Association Research Foundation, Denver, CO. 162 pp.
Livernois, J. 2002. The Economic Costs of the Walkerton Crisis. The 
Walkerton Inquiry. Commissioned Paper 14. Toronto: Ontario Ministry 
of the Attorney General. 62 pp.
Mead, P.S., L. Slutsker, V. Dietz, L.F. McCaig, J.S. Bresee, C. 
Shapiro, P.M. Griffin, R.V. Tauxe, 1999. Food-Related Illness and 
Death in the United States. Emerging Infectious Diseases. 5(5):607-
625.
Melnick, J.L. 1996. Enteroviruses: Poliovirus, Coxsackievirus, 
Echovirus, and Newer Enteroviruses. In: Fields Virology, 3rd ed. 
B.N. Fields, D.M. Knipe, and P.M. Howrey. eds. Philadelphia, 
Lippincott Raven Publishers. pp. 655-712.
Modlin, J.F. 1986. Perinatal Echovirus Infection: Insights from a 
Literature Review of 61 Cases of Serious Infection and 16 Outbreaks 
in Nurseries. Reviews of Infectious Diseases. 8(6):918-926.
Modlin, J.F. 1997. Enteroviruses: Coxsackievirus, Cchoviruses and 
Newer Enteroviruses. In: Principles and Practice of Pediatric 
Infectious Diseases. S.S. Long, et al. eds. New York. Churchill 
Livingston. pp. 1287-1295.
Moorin, R.E., J.S. Heyworth, G. M. Forbes and T.V. Riley. 2010. 
Long-term health risks for children and young adults after infective 
gastroenteritis. Emerging Infectious Diseases. 16(9):1440-1447.
NRC (National Research Council). 1997. Safe Water from Every Tap: 
Improving Water Service to Small Communities. National Academy 
Press. Washington, DC. pp. 28-47.
NY State DOH (New York State Department of Health). 2000. The 
Washington County Fair Outbreak Report. New York State Department of 
Health. Albany, New York. 108 pp.
Olsen, S.J., G. Miller, T. Breuer, M. Kennedy, C. Higgins, J. 
Walford, G. McKee, K. Fox, W. Bibb, and P. Mead. 2002. A Waterborne 
Outbreak of Escherichia coli O157:H7 Infections and Hemolytic Uremic 
Syndrome: Implications for Rural Water Systems. Emerging Infectious 
Diseases. 8(4):370-375.
OMB (Office of Management and Budget). 1996. Economic Analysis of 
Federal Regulations under Executive Order 12866. January 11, 1996. 
http://www.whitehouse.gov/omb/inforeg_riaguide/ (July 2009). 26 pp.
Parashar, U.D., J.S. Bresee, J.R. Gentsch and R. I. Glass, 1998. 
Rotavirus, Emerging Infectious Diseases 4(4): 561-570.
Parry, S. M., R.L. Salmon. 1998. Sporadic STEC 0157 Infection: 
Secondary Household Transmission in Wales. Emerging Infectious 
Diseases 4(4): 657-661.
Perz, J.F., F.K. Ennever, and S.M. Le Blancq. 1998. Cryptosporidium 
in Tap Water; Comparison of Predicted Risks with Observed Levels of 
Disease. Amer. J. Epidem. 147:289-301.
Rangel, J.M., P.H. Sparling, C. Crowe, P.M. Griffin, and D.L. 
Swerdlow. 2005. Epidemiology of Escherichia coli O157:H7 Outbreaks, 
United States, 1982-2002. Emerging Infectious Diseases. 11(4):603-
609.
Rose, J.B. 1997. Environmental Ecology of Cryptosporidium and Public 
Health Implications. Annual Rev Public Health. 18:135-161.
SAB (Science Advisory Board). 2010. Review of EPA's Supporting 
Analysis for Revisions of the Total Coliform Rule. Science Advisory 
Board Drinking Water Committee. March 19, 2010. EPA-SAB-10-004.
Skraber, S., J. Schijven, C. Gantzer, and A.M. de Roda Husman. 2005. 
Pathogenic viruses in drinking-water biofilms: a public health risk? 
Biofilms. 2:105-117.
Smith, W.G. 1970. Coxsackie B myopericarditis in adults. Am. Heart 
J. 80(1):34-46.
Swerdlow, D.L., B.A. Woodruff, R.C. Brady, P.M. Griffin, S. Tippen, 
H. Donnel Jr., E. Geldreich, B.J. Payne, A. Meyer Jr., J.G. Wells, 
K.D. Greene, M. Bright, N.H. Bean, and P.A. Blake. 1992. A 
Waterborne Outbreak in Missouri of Escherichia coli O157:H7 
Associated with Bloody Diarrhea and Death. Annals of Internal 
Medicine. 117(10):812-819.
Szewzyk, U., R. Szewzyk, W. Manz, and K.H. Schleifer. 2000. 
Microbiological safety of drinking water. Annual Review of 
Microbiology 54: 81-127.
USEPA. (United States Environmental Protection Agency). 1989a. 
Drinking Water; National Primary Drinking Water Regulations: Total 
Coliforms (Including Fecal Coliforms and E. coli); Final Rule. 54 FR 
27544. (June 29, 1989).
USEPA. 1989b. National Primary Drinking Water Regulations: 
Filtration, Disinfection, Turbidity, Giardia lamblia, Viruses, 
Legionella, and Heterotrophic Bacteria; Final Rule. 54 FR 27486. 
(June 29, 1989).
USEPA. 1998a. National Primary Drinking Water Regulations: Stage 1 
Disinfectants and Disinfection Byproducts; Final Rule. 63 FR 69389. 
(December 16, 1998).
USEPA. 1998b. National Primary Drinking Water Regulations: Interim 
Enhanced Surface Water Treatment Rule; Final Rule. 63 FR 69478. 
(December 16, 1998).
USEPA. 1999. Drinking Water Criteria Document for Enteroviruses and 
Hepatitis A: An Addendum. January 15, 1999. EPA-822-R-98-043.
USEPA. 2000a. Guidelines for Preparing Economic Analyses. US EPA 
Office of the Administrator. September 2000. EPA-240-R-00-003.
USEPA. 2000b. Health Risks of Enteric Viral Infections in Children. 
Office of Science and Technology, Washington, 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. 2006a. Economic Analysis for the Final Ground Water Rule. 
October 2006. EPA-815-R-06.014.
USEPA. 2006b. Information Collection Request for Contaminant 
Occurrence Data in Support of EPA's Second Six-Year Review of 
National Primary Drinking Water Regulations. EPA ICR Number 
2231.01., OMB Control No. 2040-NEW. August 2006.
USEPA. 2006c. National Primary Drinking Water Regulations: Ground 
Water Rule; Final Rule. 71 FR 65574. (November 8, 2006).
USEPA. 2006d. National Primary Drinking Water Regulations: Long Term 
2 Enhanced Surface Water Treatment Rule; Final Rule. 71 FR 654. 
(January 5, 2006).
USEPA. 2006e. National Primary Drinking Water Regulations: Stage 2 
Disinfectants and Disinfection Byproducts Rule; Final Rule. 71 FR 
388. (January 4, 2006).
USEPA. 2007a. Establishment of the Total Coliform Rule Distribution 
System Advisory Committee. 72 FR 35869. (June 29, 2007).
USEPA. 2007b. The Safe Drinking Water Information System--Federal 
Version (SDWIS/FED) data. Available online at http://epa.gov/enviro/html/sdwis/. Last accessed Apr 2009.
USEPA. 2007c. National Primary Drinking Water Regulations for Lead 
and Copper: Short-Term Regulatory Revisions and Clarifications; 
Final Rule. 72 FR 57782. (October 10, 2007).
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.

[[Page 10346]]

USEPA. 2008d. Total Coliform Rule/Distribution System Advisory 
Committee Meeting, 30-31 July 2008.
USEPA. 2009. National Primary Drinking Water Regulations: Airline 
Drinking Water Rule; Final Rule. 74 FR 53590. (October 19, 2009).
USEPA. 2010a. National Primary Drinking Water Regulations: Revisions 
to the Total Coliform Rule; Proposed Rule. 75 FR 40926. (July 14, 
2010).
USEPA. 2010b. Total Coliform Rule Compliance Monitoring Data Quality 
and Completion Report. EPA-815-R-10-003.
USEPA. 2010c. Six-Year Review 2 Contaminant Occurrence Data for the 
Proposed RTCR. Available by request at http://www.regulations.gov/ 
as part of the RTCR docket EPA-HQ-OW-2008-0878.
USEPA. 2010d. Proposed Revised Total Coliform Rule Assessments and 
Corrective Actions Guidance Manual, Draft. EPA-815-D-10-001.
USEPA 2012a. Economic Analysis for the Revised Total Coliform Rule. 
EPA-815-R-XX-XXX.
USEPA. 2012b. Technology and Cost Document for the Revised Total 
Coliform Rule. EPA-815-R-XX-XXX.
USEPA. 2012c. Information Collection Request for the Revised Total 
Coliform Rule. OMB Control No. 2040-AD94. EPA ICR No. 1895.06.
World Health Organization (WHO). 2004. Guidelines for Drinking-water 
Quality 3rd ed. Volume 1, Recommendations. WHO: Geneva.

List of Subjects

40 CFR Part 141

    Environmental protection, Chemicals, Incorporation by reference, 
Indian-lands, Intergovernmental relations, Radiation protection, 
Reporting and recordkeeping requirements, Water supply.

40 CFR Part 142

    Environmental protection, Administrative practice and procedure, 
Chemicals, Indian-lands, Radiation protection, Reporting and 
recordkeeping requirements, Water supply.

    Dated: December 20, 2012.
Lisa P. Jackson,
Administrator.

    For the reasons set forth in the preamble, Title 40 chapter 1 of 
the Code of Federal Regulations is amended as follows:

PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS

0
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.

0
2. Section 141.2 is amended by adding, in alphabetical order, 
definitions for ``Clean compliance history``, ``Level 1 assessment``, 
``Level 2 assessment``, ``Sanitary defect'', and ``Seasonal system'' to 
read as follows:

Sec.  141.2  Definitions.

* * * * *
    Clean compliance history is, for the purposes of subpart Y, a 
record of no MCL violations under Sec.  141.63; no monitoring 
violations under Sec.  141.21 or subpart Y; and no coliform treatment 
technique trigger exceedances or treatment technique violations under 
subpart Y.
* * * * *
    Level 1 assessment is an evaluation to identify the possible 
presence of sanitary defects, defects in distribution system coliform 
monitoring practices, and (when possible) the likely reason that the 
system triggered the assessment. It is conducted by the system operator 
or owner. Minimum elements include review and identification of 
atypical events that could affect distributed water quality or indicate 
that distributed water quality was impaired; changes in distribution 
system maintenance and operation that could affect distributed water 
quality (including water storage); source and treatment considerations 
that bear on distributed water quality, where appropriate (e.g., 
whether a ground water system is disinfected); existing water quality 
monitoring data; and inadequacies in sample sites, sampling protocol, 
and sample processing. The system must conduct the assessment 
consistent with any State directives that tailor specific assessment 
elements with respect to the size and type of the system and the size, 
type, and characteristics of the distribution system.
    Level 2 assessment is an evaluation to identify the possible 
presence of sanitary defects, defects in distribution system coliform 
monitoring practices, and (when possible) the likely reason that the 
system triggered the assessment. A Level 2 assessment provides a more 
detailed examination of the system (including the system's monitoring 
and operational practices) than does a Level 1 assessment through the 
use of more comprehensive investigation and review of available 
information, additional internal and external resources, and other 
relevant practices. It is conducted by an individual approved by the 
State, which may include the system operator. Minimum elements include 
review and identification of atypical events that could affect 
distributed water quality or indicate that distributed water quality 
was impaired; changes in distribution system maintenance and operation 
that could affect distributed water quality (including water storage); 
source and treatment considerations that bear on distributed water 
quality, where appropriate (e.g., whether a ground water system is 
disinfected); existing water quality monitoring data; and inadequacies 
in sample sites, sampling protocol, and sample processing. The system 
must conduct the assessment consistent with any State directives that 
tailor specific assessment elements with respect to the size and type 
of the system and the size, type, and characteristics of the 
distribution system. The system must comply with any expedited actions 
or additional actions required by the State in the case of an E. coli 
MCL violation.
* * * * *
    Sanitary defect is a defect that could provide a pathway of entry 
for microbial contamination into the distribution system or that is 
indicative of a failure or imminent failure in a barrier that is 
already in place.
* * * * *
    Seasonal system is a non-community water system that is not 
operated as a public water system on a year-round basis and starts up 
and shuts down at the beginning and end of each operating season.
* * * * *

0
3. Section 141.4 is revised to read as follows:

Sec.  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 Sec.  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 March 31, 2016, at which time 
the total coliform MCL is no longer effective.
    Note to paragraph (a): As provided in Sec.  142.304(a), small 
system variances are not available for rules addressing microbial 
contaminants, which would

[[Page 10347]]

include subparts H, P, S, T, W, and Y of this part.

0
4. Section 141.21 is amended by adding paragraph (h) to read as 
follows:

Sec.  141.21  Coliform sampling.

* * * * *
    (h) The provisions of paragraphs (a) and (d) of this section are 
applicable until March 31, 2016. The provisions of paragraphs (b), (c), 
(e), (f), and (g) of this section are applicable until all required 
repeat monitoring under paragraph (b) of this section and fecal 
coliform or E. coli testing under paragraph (e) of this section that 
was initiated by a total coliform-positive sample taken before April 1, 
2016 is completed, as well as analytical method, reporting, 
recordkeeping, public notification, and consumer confidence report 
requirements associated with that monitoring and testing. Beginning 
April 1, 2016, the provisions of subpart Y of this part are applicable, 
with systems required to begin regular monitoring at the same frequency 
as the system-specific frequency required on March 31, 2016.

0
5. Section 141.52 is revised to read as follows:

Sec.  141.52  Maximum contaminant level goals for microbiological 
contaminants.

    (a) MCLGs for the following contaminants are as indicated:

------------------------------------------------------------------------
                Contaminant                             MCLG
------------------------------------------------------------------------
(1) Giardia lamblia.......................  zero
(2) Viruses...............................  zero
(3) Legionella............................  zero
(4) Total coliforms (including fecal).....  zero
coliforms and Escherichia coli............
(5) Cryptosporidium.......................  zero
(6) Escherichia coli (E. coli)............  zero
------------------------------------------------------------------------

    (b) The MCLG identified in paragraph (a)(4) of this section is 
applicable until March 31, 2016. The MCLG identified in paragraph 
(a)(6) of this section is applicable beginning April 1, 2016.

0
6. Section 141.63 is revised to read as follows:

Sec.  141.63  Maximum contaminant levels (MCLs) for microbiological 
contaminants.

    (a) Until March 31, 2016, the total coliform MCL is based on the 
presence or absence of total coliforms in a sample, rather than 
coliform density.
    (1) For a system that collects at least 40 samples per month, if no 
more than 5.0 percent of the samples collected during a month are total 
coliform-positive, the system is in compliance with the MCL for total 
coliforms.
    (2) For a system that collects fewer than 40 samples per month, if 
no more than one sample collected during a month is total coliform-
positive, the system is in compliance with the MCL for total coliforms.
    (b) Until March 31, 2016, any fecal coliform-positive repeat sample 
or E. coli-positive repeat sample, or any total coliform-positive 
repeat sample following a fecal coliform-positive or E. coli-positive 
routine sample, constitutes a violation of the MCL for total coliforms. 
For purposes of the public notification requirements in subpart Q of 
this part, this is a violation that may pose an acute risk to health.
    (c) Beginning April 1, 2016, a system is in compliance with the MCL 
for E. coli for samples taken under the provisions of subpart Y of this 
part unless any of the conditions identified in paragraphs (c)(1) 
through (c)(4) of this section occur. For purposes of the public 
notification requirements in subpart Q of this part, violation of the 
MCL may pose an acute risk to health.
    (1) The system has an E. coli-positive repeat sample following a 
total coliform-positive routine sample.
    (2) The system has a total coliform-positive repeat sample 
following an E. coli-positive routine sample.
    (3) The system fails to take all required repeat samples following 
an E. coli-positive routine sample.
    (4) The system fails to test for E. coli when any repeat sample 
tests positive for total coliform.
    (d) Until March 31, 2016, a public water system must determine 
compliance with the MCL for total coliforms in paragraphs (a) and (b) 
of this section for each month in which it is required to monitor for 
total coliforms. Beginning April 1, 2016, 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.
    (f) The Administrator, pursuant to section 1412 of the Act, hereby 
identifies the technology, treatment techniques, or other means 
available identified in paragraph (e) of this section as affordable 
technology, treatment techniques, or other means available to systems 
serving 10,000 or fewer people for achieving compliance with the 
maximum contaminant level for total coliforms in paragraphs (a) and (b) 
of this section and for achieving compliance with the maximum 
contaminant level for E. coli in paragraph (c) of this section.

0
7. Section 141.71 is amended by revising paragraph (b)(5) to read as 
follows:

Sec.  141.71  Criteria for avoiding filtration.

* * * * *
    (b) * * *
    (5) The public water system must comply with the maximum 
contaminant level (MCL) for total coliforms in Sec.  141.63(a) and (b) 
and the MCL for E. coli in Sec.  141.63(c) at least 11 months of the 12 
previous months that the system served water to the public, on an 
ongoing basis, unless the State determines that failure to meet this 
requirement was not caused by a deficiency in treatment of the source 
water.
* * * * *
0
8. Section 141.74 is amended by revising paragraphs (b)(6)(i) and 
(c)(3)(i) to read as follows:

Sec.  141.74  Analytical and monitoring requirements.

* * * * *
    (b) * * *
    (6)(i) Until March 31, 2016, 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 Sec.  141.21.

[[Page 10348]]

Beginning April 1, 2016, 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 
Sec. Sec.  141.854 through 141.858. The State may allow a public water 
system which uses both a surface water source or a ground water source 
under direct influence of surface water, and a ground water source, to 
take disinfectant residual samples at points other than the total 
coliform sampling points if the State determines that such points are 
more representative of treated (disinfected) water quality within the 
distribution system. Heterotrophic bacteria, measured as heterotrophic 
plate count (HPC) as specified in paragraph (a)(1) of this section, may 
be measured in lieu of residual disinfectant concentration.
* * * * *
    (c) * * *
    (3)(i) Until March 31, 2016, 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 Sec.  141.21. Beginning April 1, 2016, 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 Sec. Sec.  141.854 through 
141.858. The State may allow a public water system which uses both a 
surface water source or a ground water source under direct influence of 
surface water, and a ground water source, to take disinfectant residual 
samples at points other than the total coliform sampling points if the 
State determines that such points are more representative of treated 
(disinfected) water quality within the distribution system. 
Heterotrophic bacteria, measured as heterotrophic plate count (HPC) as 
specified in paragraph (a)(1) of this section, may be measured in lieu 
of residual disinfectant concentration.
* * * * *

0
9. Section 141.132 is amended by revising paragraph (c)(1)(i) to read 
as follows:

Sec.  141.132  Monitoring requirements.

* * * * *
    (c) * * *
    (1) * * *
    (i) Routine monitoring. Until March 31, 2016, community and non-
transient non-community water systems that use chlorine or chloramines 
must measure the residual disinfectant level in the distribution system 
at the same point in the distribution system and at the same time as 
total coliforms are sampled, as specified in Sec.  141.21. Beginning 
April 1, 2016, community and non-transient non-community water systems 
that use chlorine or chloramines must measure the residual disinfectant 
level in the distribution system at the same point in the distribution 
system and at the same time as total coliforms are sampled, as 
specified in Sec. Sec.  141.854 through 141.858. Subpart H systems of 
this part may use the results of residual disinfectant concentration 
sampling conducted under Sec.  141.74(b)(6)(i) for unfiltered systems 
or Sec.  141.74(c)(3)(i) for systems which filter, in lieu of taking 
separate samples.
* * * * *

0
10. Section 141.153 is amended as follows:
0
a. By adding paragraphs (c)(4),
0
b. By revising paragraph (d)(4)(iv) introductory text,
0
c. By revising paragraph (d)(4)(vii) introductory text,
0
d. By revising paragraph (d)(4)(viii),
0
e. By adding paragraph (d)(4)(x), and
0
f. By adding paragraph (h)(7).

Sec.  141.153  Content of the reports.

* * * * *
    (c) * * *
    (4) A report that contains information regarding a Level 1 or Level 
2 Assessment required under Subpart Y of this part must include the 
applicable definitions:
    (i) Level 1 Assessment: A Level 1 assessment is a study of the 
water system to identify potential problems and determine (if possible) 
why total coliform bacteria have been found in our water system.
    (ii) Level 2 Assessment: A Level 2 assessment is a very detailed 
study of the water system to identify potential problems and determine 
(if possible) why an E. coli MCL violation has occurred and/or why 
total coliform bacteria have been found in our water system on multiple 
occasions.
    (d) * * *
    (4) * * *
    (iv) For contaminants subject to an MCL, except turbidity, total 
coliform, fecal coliform and E. coli, the highest contaminant level 
used to determine compliance with an NPDWR and the range of detected 
levels, as follows:
* * * * *
    (vii) For total coliform analytical results until March 31, 2016:
* * * * *
    (viii) For fecal coliform and E. coli until March 31, 2016: The 
total number of positive samples;
* * * * *
    (x) For E. coli analytical results under subpart Y: The total 
number of positive samples.
* * * * *
    (h) * * *
    (7) Systems required to comply with subpart Y. (i) Any system 
required to comply with the Level 1 assessment requirement or a Level 2 
assessment requirement that is not due to an E. coli MCL violation must 
include in the report the text found in paragraph (h)(7)(i)(A) and 
paragraphs (h)(7)(i)(B) and (C) of this section as appropriate, filling 
in the blanks accordingly and the text found in paragraphs 
(h)(7)(i)(D)(1) and (2) of this section if appropriate.
    (A) Coliforms are bacteria that are naturally present in the 
environment and are used as an indicator that other, potentially 
harmful, waterborne pathogens may be present or that a potential 
pathway exists through which contamination may enter the drinking water 
distribution system. We found coliforms indicating the need to look for 
potential problems in water treatment or distribution. When this 
occurs, we are required to conduct assessment(s) to identify problems 
and to correct any problems that were found during these assessments.
    (B) During the past year we were required to conduct [INSERT NUMBER 
OF LEVEL 1ASSESSMENTS] Level 1 assessment(s). [INSERT NUMBER OF LEVEL 1 
ASSESSMENTS] Level 1 assessment(s) were completed. In addition, we were 
required to take [INSERT NUMBER OF CORRECTIVE ACTIONS] corrective 
actions and we completed [INSERT NUMBER OF CORRECTIVE ACTIONS] of these 
actions.
    (C) During the past year [INSERT NUMBER OF LEVEL 2 ASSESSMENTS] 
Level 2 assessments were required to be completed for our water system. 
[INSERT NUMBER OF LEVEL 2 ASSESSMENTS] Level 2 assessments were 
completed. In addition, we were required to take [INSERT NUMBER OF 
CORRECTIVE ACTIONS] corrective actions and we completed [INSERT NUMBER 
OF CORRECTIVE ACTIONS] of these actions.
    (D) Any system that has failed to complete all the required 
assessments or correct all identified sanitary defects, is in violation 
of the treatment technique requirement and must also include one or 
both of the following statements, as appropriate:
    (1) During the past year we failed to conduct all of the required 
assessment(s).
    (2) During the past year we failed to correct all identified 
defects that were found during the assessment.

[[Page 10349]]

    (ii) Any system required to conduct a Level 2 assessment due to an 
E. coli MCL violation must include in the report the text found in 
paragraphs (h)(7)(ii)(A) and (B) of this section, filling in the blanks 
accordingly and the text found in paragraphs (h)(7)(ii)(C)(1) and (2) 
of this section, if appropriate.
    (A) E. coli are bacteria whose presence indicates that the water 
may be contaminated with human or animal wastes. Human pathogens in 
these wastes can cause short-term effects, such as diarrhea, cramps, 
nausea, headaches, or other symptoms. They may pose a greater health 
risk for infants, young children, the elderly, and people with severely 
compromised immune systems. We found E. coli bacteria, indicating the 
need to look for potential problems in water treatment or distribution. 
When this occurs, we are required to conduct assessment(s) to identify 
problems and to correct any problems that were found during these 
assessments.
    (B) We were required to complete a Level 2 assessment because we 
found E. coli in our water system. In addition, we were required to 
take [INSERT NUMBER OF CORRECTIVE ACTIONS] corrective actions and we 
completed [INSERT NUMBER OF CORRECTIVE ACTIONS] of these actions.
    (C) Any system that has failed to complete the required assessment 
or correct all identified sanitary defects, is in violation of the 
treatment technique requirement and must also include one or both of 
the following statements, as appropriate:
    (1) We failed to conduct the required assessment.
    (2) We failed to correct all sanitary defects that were identified 
during the assessment that we conducted.
    (iii) If a system detects E. coli and has violated the E. coli MCL, 
in addition to completing the table as required in paragraph (d)(4) of 
this section, the system must include one or more of the following 
statements to describe any noncompliance, as applicable:
    (A) We had an E. coli-positive repeat sample following a total 
coliform-positive routine sample.
    (B) We had a total coliform-positive repeat sample following an E. 
coli-positive routine sample.
    (C) We failed to take all required repeat samples following an E. 
coli-positive routine sample.
    (D) We failed to test for E. coli when any repeat sample tests 
positive for total coliform.
    (iv) If a system detects E. coli and has not violated the E. coli 
MCL, in addition to completing the table as required in paragraph 
(d)(4) of this section, the system may include a statement that 
explains that although they have detected E. coli, they are not in 
violation of the E. coli MCL.

0
11. Appendix A to Subpart O of Part 141 is amended as follows:
0
a. By revising the entries for ``Total Coliform Bacteria'' and ``Fecal 
Coliform and E. coli,''
0
b. By adding a second entry for ``Total Coliform Bacteria,''
0
c. By adding as a fourth entry ``E. coli,'' and
0
d. By adding two endnotes before Endnote 1.

                                               Appendix A to Subpart O of Part 141--Regulated Contaminants
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                 Traditional MCL in    To convert for                                         Major sources in
      Contaminant (units)               mg/L          CCR, multiply by    MCL in CCR units        MCLG         drinking water    Health effects language
--------------------------------------------------------------------------------------------------------------------------------------------------------
Microbiological contaminants:
    Total Coliform Bacteria      MCL (systems that   ..................  MCL (systems that                0  Naturally present   Coliforms are bacteria
     [dagger].                    collect >=40                            collect >=40                        in the              that are naturally
                                  samples/month) 5%                       samples/month) 5%                   environment.        present in the
                                  of monthly                              of monthly                                              environment and are
                                  samples are                             samples are                                             used as an indicator
                                  positive;                               positive;                                               that other,
                                  (systems that                           (systems that                                           potentially-harmful,
                                  collect month) 1                        samples/month) 1                                        present. Coliforms
                                  positive monthly                        positive monthly                                        were found in more
                                  sample.                                 sample..                                                samples than allowed
                                                                                                                                  and this was a warning
                                                                                                                                  of potential problems.
    Total Coliform Bacteria      TT................  ..................  TT................             N/A  Naturally present   Use language found in
     [Dagger].                                                                                                in the              Sec.
                                                                                                              environment.        141.153(h)(7)(i)(A)
Fecal coliform and E. coli       0.................  ..................  0.................               0  Human and animal    Fecal coliforms and E.
 [dagger].                                                                                                    fecal waste.        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.

[[Page 10350]]

 
E. coli [Dagger]...............  Routine and repeat  ..................  Routine and repeat               0  Human and animal    E. coli are bacteria
                                  samples are total                       samples are total                   fecal waste.        whose presence
                                  coliform-positive                       coliform-positive                                       indicates that the
                                  and either is E.                        and either is E.                                        water may be
                                  coli-positive or                        coli-positive or                                        contaminated with
                                  system fails to                         system fails to                                         human or animal
                                  take repeat                             take repeat                                             wastes. Human
                                  samples following                       samples following                                       pathogens in these
                                  E. coli-positive                        E. coli-positive                                        wastes can cause short-
                                  routine sample or                       routine sample or                                       term effects, such as
                                  system fails to                         system fails to                                         diarrhea, cramps,
                                  analyze total                           analyze total                                           nausea, headaches, or
                                  coliform-positive                       coliform-positive                                       other symptoms. They
                                  repeat sample for                       repeat sample for                                       may pose a greater
                                  E. coli.                                E. coli.                                                health risk for
                                                                                                                                  infants, young
                                                                                                                                  children, the elderly,
                                                                                                                                  and people with
                                                                                                                                  severely-compromised
                                                                                                                                  immune systems.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
[dagger] Until March 31, 2016.
[Dagger] Beginning April 1, 2016.

* * * * *

0
12. Section 141.202(a), Table 1, is amended by adding one sentence at 
the end of entry one (1) to read as follows:

Sec.  141.202  Tier 1 Public Notice--Form, manner, and frequency of 
notice.

* * * * *

  Table 1 to Sec.   141.202--Violation Categories and Other Situations
                    Requiring A Tier 1 Public Notice
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
(1) * * *
Violation of the MCL for E. coli (as specified in Sec.   141.63(c));
 
                              * * * * * * *
------------------------------------------------------------------------

0
13. Section 141.203(b)(2) is revised to read as follows:

Sec.  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.
* * * * *

0
14. Section 141.204(a), Table 1, is amended by revising entries (4) and 
(5) and adding entry (6) to read as follows:

Sec.  141.204  Tier 3 Public Notice--Form, manner, frequency of notice.

    (a) * * *

  Table 1 to Sec.   141.204--Violation Categories and Other Situations
                    Requiring a Tier 3 Public Notice
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
 
                              * * * * * * *
(4) Availability of unregulated contaminant monitoring results, as
 required under Sec.   141.207;
(5) Exceedance of the fluoride secondary maximum contaminant level
 (SMCL), as required under Sec.   141.208; and
(6) Reporting and Recordkeeping violations under subpart Y of 40 CFR
 part 141.
------------------------------------------------------------------------

* * * * *

0
15. Appendix A to subpart Q of Part 141 is amended as follows:
0
a. By revising entries I.A.1 and I.A.2,
0
b. By adding two endnotes before Endnote 1, and
0
c. By revising Endnote 1.

[[Page 10351]]

     Appendix A to Subpart Q of Part 141--NPDWR Violations and Other Situations Requiring Public Notice \1\
----------------------------------------------------------------------------------------------------------------
                                              MCL/MRDL/TT violations \2\        Monitoring, testing & reporting
                                         ------------------------------------        procedure violations
               Contaminant                                                   -----------------------------------
                                           Tier of public       Citation       Tier of public
                                           notice required                     notice required      Citation
----------------------------------------------------------------------------------------------------------------
I. Violations of National Primary
 Drinking Water Regulations (NPDWR): \3\
A. Microbiological Contaminants.........
    1.a Total coliform bacteria [dagger]                 2         141.63(a)                 3     141.21(a)-(e)
    1.b Total coliform (Monitoring or TT                 2        141.860(b)                 3        141.860(c)
     violations resulting from failure
     to perform assessments or
     corrective actions) [Dagger].......
    1.c Seasonal system failure to                       2     141.860(b)(2)  ................  ................
     follow State-approved start-up plan
     prior to serving water to the
     public. [Dagger]...................
    2.a Fecal coliform/E. coli [dagger].                 1         141.63(b)           \4\ 1,3         141.21(e)
    2.b E. coli [Dagger]................                 1       141.860 (a)                 3        141.860(c)
                                                                                                   141.860(d)(2)
    2.c E.coli (TT violations resulting                  2        141.860(b)  ................  ................
     from failure to perform level 2
     Assessments or corrective action)
     [Dagger]...........................
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

Appendix A--Endnotes

    [dagger] Until March 31, 2016.
    [Dagger] Beginning April 1, 2016.
    1. Violations and other situations not listed in this table 
(e.g., failure to prepare Consumer Confidence Reports), do not 
require notice, unless otherwise determined by the primacy agency. 
Primacy agencies may, at their option, also require a more stringent 
public notice tier (e.g., Tier 1 instead of Tier 2 or Tier 2 instead 
of Tier 3) for specific violations and situations listed in this 
Appendix, as authorized under Sec.  141.202(a) and Sec.  141.203(a).
    2. MCL--Maximum contaminant level, MRDL--Maximum residual 
disinfectant level, TT--Treatment technique
    3. The term Violations of National Primary Drinking Water 
Regulations (NPDWR) is used here to include violations of MCL, MRDL, 
treatment technique, monitoring, and testing procedure requirements.
    4. Failure to test for fecal coliform or E. coli is a Tier 1 
violation if testing is not done after any repeat sample tests 
positive for coliform. All other total coliform monitoring and 
testing procedure violations are Tier 3.

* * * * *

0
16. Appendix B to subpart Q of Part 141 is amended as follows:
0
a. By revising entries 1a and 1b,
0
b. By adding entries 1e, 1f, 1g and 1h, and
0
c. By adding two endnotes before Endnote 1.

          Appendix B to Subpart Q of Part 141--Standard Health Effects Language for Public Notification
----------------------------------------------------------------------------------------------------------------
                                                                                       Standard health effects
            Contaminant                    MCLG\1\mg/L             MCL\2\mg/L            language for public
                                                                                             notification
----------------------------------------------------------------------------------------------------------------
                               National Primary Drinking Water Regulations (NPDWR)
----------------------------------------------------------------------------------------------------------------
                                         A. Microbiological Contaminants
----------------------------------------------------------------------------------------------------------------
1a. Total coliform [dagger]........  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 [dagger]  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.
 

[[Page 10352]]

 
                                                  * * * * * * *
1e. Subpart Y Coliform Assessment    N/A...................  TT....................  Coliforms are bacteria that
 and/or Corrective Action                                                             are naturally present in
 Violations [Dagger].                                                                 the environment and are
                                                                                      used as an indicator that
                                                                                      other, potentially
                                                                                      harmful, waterborne
                                                                                      pathogens may be present
                                                                                      or that a potential
                                                                                      pathway exists through
                                                                                      which contamination may
                                                                                      enter the drinking water
                                                                                      distribution system. We
                                                                                      found coliforms indicating
                                                                                      the need to look for
                                                                                      potential problems in
                                                                                      water treatment or
                                                                                      distribution. When this
                                                                                      occurs, we are required to
                                                                                      conduct assessments to
                                                                                      identify problems and to
                                                                                      correct any problems that
                                                                                      are found.
                                                                                     [THE SYSTEM MUST USE THE
                                                                                      FOLLOWING APPLICABLE
                                                                                      SENTENCES.]
                                                                                     We failed to conduct the
                                                                                      required assessment.
                                                                                     We failed to correct all
                                                                                      identified sanitary
                                                                                      defects that were found
                                                                                      during the assessment(s).
1f. Subpart Y E.coli Assessment and/ N/A...................  TT....................  E. coli are bacteria whose
 or Corrective Action Violations                                                      presence indicates that
 [Dagger].                                                                            the water may be
                                                                                      contaminated with human or
                                                                                      animal wastes. Human
                                                                                      pathogens in these wastes
                                                                                      can cause short-term
                                                                                      effects, such as diarrhea,
                                                                                      cramps, nausea, headaches,
                                                                                      or other symptoms. They
                                                                                      may pose a greater health
                                                                                      risk for infants, young
                                                                                      children, the elderly, and
                                                                                      people with severely
                                                                                      compromised immune
                                                                                      systems. We violated the
                                                                                      standard for E. coli,
                                                                                      indicating the need to
                                                                                      look for potential
                                                                                      problems in water
                                                                                      treatment or distribution.
                                                                                      When this occurs, we are
                                                                                      required to conduct a
                                                                                      detailed assessment to
                                                                                      identify problems and to
                                                                                      correct any problems that
                                                                                      are found.
                                                                                     [THE SYSTEM MUST USE THE
                                                                                      FOLLOWING APPLICABLE
                                                                                      SENTENCES.]
                                                                                     We failed to conduct the
                                                                                      required assessment.
                                                                                     We failed to correct all
                                                                                      identified sanitary
                                                                                      defects that were found
                                                                                      during the assessment that
                                                                                      we conducted.
1g. E. coli [Dagger]...............  Zero..................  In compliance unless    E. coli are bacteria whose
                                                              one of the following    presence indicates that
                                                              conditions occurs:.     the water may be
                                                             (1) The system has an    contaminated with human or
                                                              E. coli-positive        animal wastes. Human
                                                              repeat sample           pathogens in these wastes
                                                              following a total       can cause short-term
                                                              coliform-positive       effects, such as diarrhea,
                                                              routine sample..        cramps, nausea, headaches,
                                                             (2) The system has a     or other symptoms. They
                                                              total coliform-         may pose a greater health
                                                              positive repeat         risk for infants, young
                                                              sample following an     children, the elderly, and
                                                              E. coli-positive        people with severely
                                                              routine sample..        compromised immune
                                                             (3) The system fails     systems.
                                                              to take all required
                                                              repeat samples
                                                              following an E. coli-
                                                              positive routine
                                                              sample..
                                                             (4) The system fails
                                                              to test for E. coli
                                                              when any repeat
                                                              sample tests positive
                                                              for total coliform..
1h. Subpart Y Seasonal System TT     N/A...................  TT....................  When this violation
 Violations [Dagger].                                                                 includes the failure to
                                                                                      monitor for total
                                                                                      coliforms or E. coli prior
                                                                                      to serving water to the
                                                                                      public, the mandatory
                                                                                      language found at
                                                                                      141.205(d)(2) must be
                                                                                      used.
                                                                                     When this violation
                                                                                      includes failure to
                                                                                      complete other actions,
                                                                                      the appropriate elements
                                                                                      found in 141.205(a) to
                                                                                      describe the violation
                                                                                      must be used.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[[Page 10353]]

Appendix B--Endnotes

    [dagger] Until March 31, 2016.
    [Dagger] Beginning April 1, 2016.
    1. MCLG--Maximum contaminant level goal
    2. MCL--Maximum contaminant level
    3. For water systems analyzing at least 40 samples per month, no 
more than 5.0 percent of the monthly samples may be positive for 
total coliforms. For systems analyzing fewer than 40 samples per 
month, no more than one sample per month may be positive for total 
coliforms.

* * * * *

0
17. Section 141.402 is amended by revising paragraph (a) to read as 
follows:

Sec.  141.402  Ground water source microbial monitoring and analytical 
methods.

    (a) Triggered source water monitoring--
    (1) General requirements. A ground water system must conduct 
triggered source water monitoring if the conditions identified in 
paragraphs (a)(1)(i) and either (a)(1)(ii) or (a)(1)(iii) of this 
section exist.
    (i) The system does not provide at least 4-log treatment of viruses 
(using inactivation, removal, or a State-approved combination of 4-log 
virus inactivation and removal) before or at the first customer for 
each ground water source; and either
    (ii) The system is notified that a sample collected under Sec.  
141.21(a) is total coliform-positive and the sample is not invalidated 
under Sec.  141.21(c) until March 31, 2016, or
    (iii) The system is notified that a sample collected under 
Sec. Sec.  141.854 through 141.857 is total coliform-positive and the 
sample is not invalidated under Sec.  141.853(c) beginning April 1, 
2016.
    (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 Sec.  141.21(a) until March 31, 2016, or collected under 
Sec. Sec.  141.854 through 141.857 beginning April 1, 2016, 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 Sec.  141.21(a) until March 31, 2016, or under Sec.  
141.853 beginning April 1, 2016, and that the system intends to use for 
representative sampling under this paragraph.
    (iii) Until March 31, 2016, 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 Sec.  141.21(b) and to satisfy 
the monitoring requirements of paragraph (a)(2) of this section for 
that ground water source only if the State approves the use of E. coli 
as a fecal indicator for source water monitoring under this paragraph 
(a). If the repeat sample collected from the ground water source is E. 
coli-positive, the system must comply with paragraph (a)(3) of this 
section.
    (iv) Beginning April 1, 2016, 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 Sec.  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 Sec.  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 Sec.  
141.21(a) until March 31, 2016, or under Sec. Sec.  141.854 through 
141.857 beginning April 1, 2016, must notify the wholesale system(s) 
within 24 hours of being notified of the total coliform-positive 
sample.
    (ii) In addition to the other requirements of this paragraph (a), a 
wholesale ground water system must comply with paragraphs (a)(4)(ii)(A) 
and (a)(4)(ii)(B) of this section.
    (A) A wholesale ground water system that receives notice from a 
consecutive system it serves that a sample collected under Sec.  
141.21(a) until March 31, 2016, or collected under Sec. Sec.  141.854 
through 141.857 beginning April 1, 2016, 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 Sec.  141.21(a) until March 
31, 2016, or under Sec. Sec.  141.854 through 141.857 beginning April 
1, 2016, is caused by a distribution system deficiency; or
    (ii) The total coliform-positive sample collected under Sec.  
141.21(a) until March 31, 2016, or under Sec. Sec.  141.854 through 
141.857 beginning April 1, 2016, is collected at a location that meets 
State criteria for distribution system conditions that will cause total 
coliform-positive samples.
* * * * *

0
18. Section 141.405 is amended by revising paragraph (b)(4) to read as 
follows:

Sec.  141.405  Reporting and recordkeeping for ground water systems.

* * * * *
    (b) * * *
    (4) For consecutive systems, documentation of notification to the 
wholesale system(s) of total coliform-positive samples that are not 
invalidated under Sec.  141.21(c) until March 31, 2016, or under Sec.  
141.853 beginning April 1,

[[Page 10354]]

2016. Documentation shall be kept for a period of not less than five 
years.
* * * * *

0
19. Section 141.803 is amended by revising paragraphs (a)(3) and (a)(5) 
to read as follows:

Sec.  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 Sec.  
141.21(f)(3) and 141.21(f)(6)) until March 31, 2016, and in accordance 
with the analytical methods approved in Sec.  141.852 beginning April 
1, 2016.
* * * * *
    (5) The invalidation of a total coliform sample result can be made 
only by the Administrator in accordance with Sec.  141.21(c)(1)(i), 
(ii), or (iii) or by the certified laboratory in accordance with Sec.  
141.21(c)(2) until March 31, 2016, or in accordance with Sec.  
141.853(c) beginning April 1, 2016, with the Administrator acting as 
the State.
* * * * *

0
20. Part 141 is amended by adding a new subpart Y to read as follows:
Subpart Y--Revised Total Coliform Rule
Sec.
141.851 General.
141.852 Analytical methods and laboratory certification.
141.853 General monitoring requirements for all public water 
systems.
141.854 Routine monitoring requirements for non-community water 
systems serving 1,000 or fewer people using only ground water.
141.855 Routine monitoring requirements for community water systems 
serving 1,000 or fewer people using only ground water.
141.856 Routine monitoring requirements for subpart H public water 
systems of this part serving 1,000 or fewer people.
141.857 Routine monitoring requirements for public water systems 
serving more than 1,000 people.
141.858 Repeat monitoring and E. coli requirements.
141.859 Coliform treatment technique triggers and assessment 
requirements for protection against potential fecal contamination.
141.860 Violations.
141.861 Reporting and recordkeeping.

Subpart Y--Revised Total Coliform Rule

Sec.  141.851  General.

    (a) General. The provisions of this subpart include both maximum 
contaminant level and treatment technique requirements.
    (b) Applicability. The provisions of this subpart apply to all 
public water systems.
    (c) Compliance date. Systems must comply with the provisions of 
this subpart beginning April 1, 2016, unless otherwise specified in 
this subpart.
    (d) Implementation with EPA as State. Systems falling under direct 
oversight of EPA, where EPA acts as the State, must comply with 
decisions made by EPA for implementation of subpart Y. EPA has 
authority to establish such procedures and criteria as are necessary to 
implement subpart Y.
    (e) Violations of national primary drinking water regulations. 
Failure to comply with the applicable requirements of Sec. Sec.  
141.851 through 141.861, including requirements established by the 
State pursuant to these provisions, is a violation of the national 
primary drinking water regulations under subpart Y.

Sec.  141.852  Analytical methods and laboratory certification.

    (a) Analytical methodology. (1) The standard sample volume required 
for analysis, regardless of analytical method used, is 100 ml.
    (2) Systems need only determine the presence or absence of total 
coliforms and E. coli; a determination of density is not required.
    (3) The time from sample collection to initiation of test medium 
incubation may not exceed 30 hours. Systems are encouraged but not 
required to hold samples below 10 deg. C during transit.
    (4) If water having residual chlorine (measured as free, combined, 
or total chlorine) is to be analyzed, sufficient sodium thiosulfate 
(Na2S2O3) must be added to the sample 
bottle before sterilization to neutralize any residual chlorine in the 
water sample. Dechlorination procedures are addressed in Section 
9060A.2 of Standard Methods for the Examination of Water and Wastewater 
(20th and 21st editions).
    (5) Systems must conduct total coliform and E. coli analyses in 
accordance with one of the analytical methods in the following table or 
one of the alternative methods listed in Appendix A to subpart C of 
part 141.

----------------------------------------------------------------------------------------------------------------
             Organism                 Methodology category            Method 1                 Citation 1
----------------------------------------------------------------------------------------------------------------
         Total Coliforms
                                   Lactose Fermentation       Standard Total Coliform   Standard Methods 9221
                                    Methods.                   Fermentation Technique.   B.1, B.2 (20th ed.;
                                                                                         21st ed.) 2 3
                                                                                        Standard Methods Online
                                                                                        9221 B.1, B.2-99 2 3
                                                              Presence-Absence (P-A)    Standard Methods 9221
                                                               Coliform Test.            D.1, D.2 (20th ed.;
                                                                                         21st ed.) 2 7
                                                                                        Standard Methods Online
                                                                                         9221 D.1, D.2-99 2 7
                                   Membrane Filtration        Standard Total Coliform   Standard Methods 9222 B,
                                    Methods.                   Membrane Filter           C (20th ed.; 21st ed.)
                                                               Procedure.                2 4
                                                                                        Standard Methods Online
                                                                                         9222 B-97 2 4, 9222 C-
                                                                                         97 2 4
                                                              Membrane Filtration       EPA Method 1604 2
                                                               using MI medium.
                                                              m-ColiBlue24[supreg]
                                                               Test 2 4
                                                              Chromocult 2 4..........
                                   Enzyme Substrate Methods.  Colilert[supreg]........  Standard Methods 9223 B
                                                                                         (20th ed.; 21st ed.) 2
                                                                                         5
                                                              Standard Methods Online
                                                               9223 B-97 2 5
                                                              Colisure[supreg]........  Standard Methods 9223 B
                                                                                         (20th ed.; 21st ed.) 2
                                                                                         5 6
                                                                                        Standard Methods Online
                                                                                        9223 B-97 2 5 6
                                                              E*Colite[supreg] Test 2.
                                                              Readycult[supreg] Test 2

[[Page 10355]]

 
                                                              modified Colitag[supreg]
                                                               Test 2.
Escherichia coli.................
                                   Escherichia coli           EC-MUG medium...........  Standard Methods 9221
                                    Procedure (following                                 F.1 (20th ed.; 21st
                                    Lactose Fermentation                                 ed.) 2
                                    Methods).
                                   Escherichia coli           EC broth with MUG (EC-    Standard Methods 9222
                                    Partition Method.          MUG).                     G.1c(2) (20th ed.; 21st
                                                                                         ed.) 2 8
                                                              NA-MUG medium...........  Standard Methods 9222
                                                                                         G.1c(1) (20th ed.; 21st
                                                                                         ed.) 2
                                   Membrane Filtration        Membrane Filtration       EPA Method 1604 2
                                    Methods.                   using MI medium.
                                                              m-ColiBlue24[supreg]
                                                               Test 2 4.
                                                              Chromocult 2 4..........
                                   Enzyme Substrate Methods.  Colilert[supreg]........  Standard Methods 9223 B
                                                                                         (20th ed.; 21st ed.) 2
                                                                                         5
                                                                                        Standard Methods Online
                                                                                         9223 B-97 2 5 6
                                                              Colisure[supreg]........  Standard Methods 9223 B
                                                                                         (20th ed.; 21st ed.) 2
                                                                                         5 6
                                                                                        Standard Methods Online
                                                                                        9223 B-97 2 5 6
                                                              E*Colite[supreg] Test 2.
                                                              Readycult[supreg] Test 2
                                                              modified Colitag[supreg]
                                                               Test 2.
----------------------------------------------------------------------------------------------------------------
1 The procedures must be done in accordance with the documents listed in paragraph (c) of this section. For
  Standard Methods, either editions, 20th (1998) or 21st (2005), may be used. For the Standard Methods Online,
  the year in which each method was approved by the Standard Methods Committee is designated by the last two
  digits following the hyphen in the method number. The methods listed are the only online versions that may be
  used. For vendor methods, the date of the method listed in paragraph (c) of this section is the date/version
  of the approved method. The methods listed are the only versions that may be used for compliance with this
  rule. Laboratories should be careful to use only the approved versions of the methods, as product package
  inserts may not be the same as the approved versions of the methods.
2 Incorporated by reference. See paragraph (c) of this section.
3 Lactose broth, as commercially available, may be used in lieu of lauryl tryptose broth, if the system conducts
  at least 25 parallel tests between lactose broth and lauryl tryptose broth using the water normally tested,
  and if the findings from this comparison demonstrate that the false-positive rate and false-negative rate for
  total coliforms, using lactose broth, is less than 10 percent.
4 All filtration series must begin with membrane filtration equipment that has been sterilized by autoclaving.
  Exposure of filtration equipment to UV light is not adequate to ensure sterilization. Subsequent to the
  initial autoclaving, exposure of the filtration equipment to UV light may be used to sanitize the funnels
  between filtrations within a filtration series. Alternatively, membrane filtration equipment that is pre-
  sterilized by the manufacturer (i.e., disposable funnel units) may be used.
5 Multiple-tube and multi-well enumerative formats for this method are approved for use in presence-absence
  determination under this regulation.
6 Colisure[supreg] results may be read after an incubation time of 24 hours.
7 A multiple tube enumerative format, as described in Standard Methods for the Examination of Water and
  Wastewater 9221, is approved for this method for use in presence-absence determination under this regulation.
8 The following changes must be made to the EC broth with MUG (EC-MUG) formulation: Potassium dihydrogen
  phosphate, KH2PO4, must be 1.5g, and 4-methylumbelliferyl-Beta-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 
associated contaminant(s)) used for compliance monitoring analyses 
under this rule.
    (c) Incorporation by reference. The standards required in this 
section are incorporated by reference into this section with the 
approval of the Director of the Federal Register under 5 U.S.C. 552(a) 
and 1 CFR part 51. To enforce any edition other than that specified in 
this section, EPA must publish notice of change in the Federal Register 
and the material must be available to the public. All approved material 
is available for inspection either electronically at 
www.regulations.gov, in hard copy at the Water Docket, or from the 
sources indicated below. The Docket ID is EPA-HQ-OW-2008-0878. Hard 
copies of these documents may be viewed at the Water Docket in the EPA 
Docket Center, (EPA/DC) EPA West, Room 3334, 1301 Constitution Ave. 
NW., Washington, DC. The EPA Docket Center Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is 1-202-
566-1744, and the telephone number for the Water Docket is 1-202-566-
2426. Copyrighted materials are only available for viewing in hard 
copy. These documents are also available for inspection at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 1-202-741-6030 or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_ locations.html.
    (1) American Public Health Association, 800 I Street, NW., 
Washington, DC 20001.
    (i) ``Standard Methods for the Examination of Water and 
Wastewater,'' 20th edition (1998):
    (A) Standard Methods 9221, ``Multiple-Tube Fermentation Technique 
for Members of the Coliform Group,'' B.1, B.2, ``Standard Total 
Coliform Fermentation Technique.''
    (B) Standard Methods 9221, ``Multiple-Tube Fermentation Technique 
for Members of the Coliform Group,'' D.1, D.2, ``Presence-Absence (P-A) 
Coliform Test.''
    (C) Standard Methods 9222, ``Membrane Filter Technique for Members 
of the Coliform Group,'' B, ``Standard Total Coliform Membrane Filter 
Procedure.''
    (D) Standard Methods 9222, ``Membrane Filter Technique for Members 
of the Coliform Group,'' C,

[[Page 10356]]

``Delayed-Incubation Total Coliform Procedure.''
    (E) Standard Methods 9223, ``Enzyme Substrate Coliform Test,'' B, 
``Enzyme Substrate Test,'' Colilert[supreg] and Colisure[supreg].
    (F) Standard Methods 9221, ``Multiple Tube Fermentation Technique 
for Members of the Coliform Group,'' F.1, ``Escherichia coli Procedure: 
EC-MUG medium.''
    (G) Standard Methods 9222, ``Membrane Filter Technique for Members 
of the Coliform Group,'' G.1.c(2), ``Escherichia coli Partition Method: 
EC broth with MUG (EC-MUG).''
    (H) Standard Methods 9222, ``Membrane Filter Technique for Members 
of the Coliform Group,'' G.1.c(1), ``Escherichia coli Partition Method: 
NA-MUG medium.''
    (ii) ``Standard Methods for the Examination of Water and 
Wastewater,'' 21st edition (2005):
    (A) Standard Methods 9221, ``Multiple-Tube Fermentation Technique 
for Members of the Coliform Group,'' B.1, B.2, ``Standard Total 
Coliform Fermentation Technique.''
    (B) Standard Methods 9221, ``Multiple-Tube Fermentation Technique 
for Members of the Coliform Group,'' D.1, D.2, ``Presence-Absence (P-A) 
Coliform Test.''
    (C) Standard Methods 9222, ``Membrane Filter Technique for Members 
of the Coliform Group,'' B, ``Standard Total Coliform Membrane Filter 
Procedure.''
    (D) Standard Methods 9222, ``Membrane Filter Technique for Members 
of the Coliform Group,'' C, ``Delayed-Incubation Total Coliform 
Procedure.''
    (E) Standard Methods 9223, ``Enzyme Substrate Coliform Test,'' B, 
``Enzyme Substrate Test,'' Colilert[supreg] and Colisure[supreg].
    (F) Standard Methods 9221, ``Multiple Tube Fermentation Technique 
for Members of the Coliform Group,'' F.1, ``Escherichia coli Procedure: 
EC-MUG medium.''
    (G) Standard Methods 9222, ``Membrane Filter Technique for Members 
of the Coliform Group,'' G.1.c(2), ``Escherichia coli Partition Method: 
EC broth with MUG (EC-MUG).''
    (H) Standard Methods 9222, ``Membrane Filter Technique for Members 
of the Coliform Group,'' G.1.c(1), ``Escherichia coli Partition Method: 
NA-MUG medium.''
    (iii) ``Standard Methods Online'' available at http://www.standardmethods.org:
    (A) Standard Methods Online 9221, ``Multiple-Tube Fermentation 
Technique for Members of the Coliform Group'' (1999), B.1, B.2-99, 
``Standard Total Coliform Fermentation Technique.''
    (B) Standard Methods Online 9221, ``Multiple-Tube Fermentation 
Technique for Members of the Coliform Group'' (1999), D.1, D.2-99, 
``Presence-Absence (P-A) Coliform Test.''
    (C) Standard Methods Online 9222, ``Membrane Filter Technique for 
Members of the Coliform Group'' (1997), B-97, ``Standard Total Coliform 
Membrane Filter Procedure.''
    (D) Standard Methods Online 9222, ``Membrane Filter Technique for 
Members of the Coliform Group'' (1997), C-97, ``Delayed-Incubation 
Total Coliform Procedure.''
    (E) Standard Methods Online 9223, ``Enzyme Substrate Coliform 
Test'' (1997), B-97, ``Enzyme Substrate Test'', Colilert[supreg] and 
Colisure[supreg].
    (2) Charm Sciences, Inc., 659 Andover Street, Lawrence, MA 01843-
1032, telephone 1-800-343-2170:
    (i) E*Colite[supreg]--``Charm E*ColiteTM Presence/
Absence Test for Detection and Identification of Coliform Bacteria and 
Escherichia coli in Drinking Water,'' January 9, 1998.
    (ii) [Reserved]
    (3) CPI International, Inc., 5580 Skylane Blvd., Santa Rosa, CA, 
95403, telephone 1-800-878-7654:
    (i) modified Colitag[supreg], ATP D05-0035--``Modified 
ColitagTM Test Method for the Simultaneous Detection of E. 
coli and other Total Coliforms in Water,'' August 28, 2009.
    (ii) [Reserved]
    (4) EMD Millipore (a division of Merck KGaA, Darmstadt Germany), 
290 Concord Road, Billerica, MA 01821, telephone 1-800-645-5476:
    (i) Chromocult--``Chromocult[supreg] Coliform Agar Presence/Absence 
Membrane Filter Test Method for Detection and Identification of 
Coliform Bacteria and Escherichia coli for Finished Waters,'' November 
2000, Version 1.0.
    (ii) Readycult[supreg]--``Readycult[supreg] Coliforms 100 Presence/
Absence Test for Detection and Identification of Coliform Bacteria and 
Escherichia coli in Finished Waters,'' January 2007, Version 1.1.
    (5) EPA's Water Resource Center (MC-4100T), 1200 Pennsylvania 
Avenue NW., Washington, DC 20460, telephone 1-202-566-1729:
    (i) EPA Method 1604, EPA 821-R-02-024--``EPA Method 1604: Total 
Coliforms and Escherichia coli in Water by Membrane Filtration Using a 
Simultaneous Detection Technique (MI Medium),'' September 2002, http://www.epa.gov/nerlcwww/1604sp02.pdf.
    (ii) [Reserved]
    (6) Hach Company, P.O. Box 389, Loveland, CO 80539, telephone 1-
800-604-3493:
    (i) m-ColiBlue24[supreg]--``Membrane Filtration Method m-
ColiBlue24[supreg] Broth,'' Revision 2, August 17, 1999.
    (ii) [Reserved]

Sec.  141.853  General monitoring requirements for all public water 
systems.

    (a) Sample siting plans. (1) Systems must develop a written sample 
siting plan that identifies sampling sites and a sample collection 
schedule that are representative of water throughout the distribution 
system not later than March 31, 2016. These plans are subject to State 
review and revision. Systems must collect total coliform samples 
according to the written sample siting plan. Monitoring required by 
Sec. Sec.  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) Systems must take at least the minimum number of required 
samples even if the system has had an E. coli MCL violation or has 
exceeded the coliform treatment technique triggers in Sec.  141.859(a).
    (4) A system may conduct more compliance monitoring than is 
required by this subpart to investigate potential problems in the 
distribution system and use monitoring as a tool to assist in 
uncovering problems. A system may take more than the minimum number of 
required routine samples and must include the results in calculating 
whether the coliform treatment technique trigger in Sec.  
141.859(a)(1)(i) and (ii) has been exceeded only if the samples are 
taken in accordance with the existing sample siting plan and are 
representative of water throughout the distribution system.
    (5) Systems must identify repeat monitoring locations in the sample 
siting plan. Unless the provisions of paragraphs (a)(5)(i) or 
(a)(5)(ii) of this section are met, the system must collect at least 
one repeat sample from the sampling tap where the original total 
coliform-positive sample was taken, and at least one repeat sample at a 
tap within five service connections upstream and at least one repeat 
sample

[[Page 10357]]

at a tap within five service connections downstream of the original 
sampling site. If a total coliform-positive sample is at the end of the 
distribution system, or one service connection away from the end of the 
distribution system, the system must still take all required repeat 
samples. However, the State may allow an alternative sampling location 
in lieu of the requirement to collect at least one repeat sample 
upstream or downstream of the original sampling site. Except as 
provided for in paragraph (a)(5)(ii) of this section, systems required 
to conduct triggered source water monitoring under Sec.  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 or require 
alternative monitoring locations as needed.
    (ii) Ground water systems serving 1,000 or fewer people may propose 
repeat sampling locations to the State that differentiate potential 
source water and distribution system contamination (e.g., by sampling 
at entry points to the distribution system). A ground water system with 
a single well required to conduct triggered source water monitoring 
may, with written State approval, take one of its repeat samples at the 
monitoring location required for triggered source water monitoring 
under Sec.  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 Sec.  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 Sec.  
141.402(a)(3). If a system takes more than one repeat sample at the 
monitoring location required for triggered source water monitoring, the 
system may reduce the number of additional source water samples 
required under Sec.  141.402(a)(3) by the number of repeat samples 
taken at that location that were not E. coli-positive.
    (B) If a system takes more than one repeat sample at the monitoring 
location required for triggered source water monitoring under Sec.  
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 Sec.  
141.403(a)(1).
    (C) If all repeat samples taken at the monitoring location required 
for triggered source water monitoring are E. coli-negative and a repeat 
sample taken at a monitoring location other than the one required for 
triggered source water monitoring is E. coli-positive, the system has 
violated the E. coli MCL, but is not required to comply with Sec.  
141.402(a)(3).
    (6) States may review, revise, and approve, as appropriate, repeat 
sampling proposed by systems under paragraphs (a)(5)(i) and (ii) of 
this section. The system must demonstrate 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 Sec.  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 Sec.  141.858(a), determines that the total 
coliform-positive sample resulted from a domestic or other non-
distribution system plumbing problem. The State cannot invalidate a 
sample on the basis of repeat sample results unless all repeat 
sample(s) collected at the same tap as the original total coliform-
positive sample are also total coliform-positive, and all repeat 
samples collected at a location other than the original tap are total 
coliform-negative (e.g., a State cannot invalidate a total coliform-
positive sample on the basis of repeat samples if all the repeat 
samples are total coliform-negative, or if the system has only one 
service connection).
    (iii) The State has substantial grounds to believe that a total 
coliform-positive result is due to a circumstance or condition that 
does not reflect water quality in the distribution system. In this 
case, the system must still collect all repeat samples required under 
Sec.  141.858(a), and use them to determine whether a coliform 
treatment technique trigger in Sec.  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 coliform-negative.
    (2) A laboratory must invalidate a total coliform sample (unless 
total coliforms are detected) if the sample produces a turbid culture 
in the absence of gas production using an analytical method where gas 
formation is examined (e.g., the Multiple-Tube Fermentation Technique), 
produces a turbid culture in the absence of an acid reaction in the 
Presence-Absence (P-A) Coliform Test, or exhibits confluent growth or 
produces colonies too numerous to count with an analytical method using 
a membrane filter (e.g., Membrane Filter Technique). If a laboratory 
invalidates a sample because of such interference, the system must 
collect another sample from the same location as the original sample 
within 24 hours of being notified of the interference problem, and have 
it analyzed for the presence of total coliforms. The system must 
continue to re-sample within 24 hours and have the samples analyzed 
until it obtains a valid result. The State may waive the 24-hour time 
limit on a case-by-case basis. Alternatively, the State may implement 
criteria for waiving the 24-hour

[[Page 10358]]

sampling time limit to use in lieu of case-by-case extensions.

Sec.  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 Sec.  141.2) 
and serving 1,000 or fewer people.
    (2) Following any total coliform-positive sample taken under the 
provisions of this section, systems must comply with the repeat 
monitoring requirements and E. coli analytical requirements in Sec.  
141.858.
    (3) Once all monitoring required by this section and Sec.  141.858 
for a calendar month has been completed, systems must determine whether 
any coliform treatment technique triggers specified in Sec.  141.859 
have been exceeded. If any trigger has been exceeded, systems must 
complete assessments as required by Sec.  141.859.
    (4) For the purpose of determining eligibility for remaining on or 
qualifying for quarterly monitoring under the provisions of paragraphs 
(f)(4) and (g)(2), respectively, of this section for transient non-
community water systems, the State may elect to not count monitoring 
violations under Sec.  141.860(c)(1) of this part if the missed sample 
is collected no later than the end of the monitoring period following 
the monitoring period in which the sample was missed. The system must 
collect the make-up sample in a different week than the routine sample 
for that monitoring period and should collect the sample as soon as 
possible during the monitoring period. The State may not use this 
provision under paragraph (h) of this section. This authority does not 
affect the provisions of Sec. Sec.  141.860(c)(1) and 141.861(a)(4) of 
this part.
    (b) Monitoring frequency for total coliforms. Systems must monitor 
each calendar quarter that the system provides water to the public, 
except for seasonal systems or as provided under paragraphs (c) through 
(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 Sec.  141.21 that were in effect on March 
31, 2016, unless any of the conditions for increased monitoring in 
paragraph (f) of this section are triggered on or after April 1, 2016, 
or unless otherwise directed by the State.
    (2) Beginning April 1, 2016, the State must perform a special 
monitoring evaluation during each sanitary survey to review the status 
of the system, including the distribution system, to determine whether 
the system is on an appropriate monitoring schedule. After the State 
has performed the special monitoring evaluation during each sanitary 
survey, the State may modify the system's monitoring schedule, as 
necessary, or it may allow the system to stay on its existing 
monitoring schedule, consistent with the provisions of this section. 
The State may not allow systems to begin less frequent monitoring under 
the special monitoring evaluation unless the system has already met the 
applicable criteria for less frequent monitoring in this section. For 
seasonal systems on quarterly or annual monitoring, this evaluation 
must include review of the approved sample siting plan, which must 
designate the time period(s) for monitoring based on site-specific 
considerations (e.g., during periods of highest demand or highest 
vulnerability to contamination). The seasonal system must collect 
compliance samples during these time periods.
    (d) Annual site visits. Beginning no later than calendar year 2017, 
systems on annual monitoring, including seasonal systems, must have an 
initial and recurring annual site visit by the State that is equivalent 
to a Level 2 assessment or an annual voluntary Level 2 assessment that 
meets the criteria in Sec.  141.859(b) to remain on annual monitoring. 
The periodic required sanitary survey may be used to meet the 
requirement for an annual site visit for the year in which the sanitary 
survey was completed.
    (e) Criteria for annual monitoring. Beginning April 1, 2016, the 
State may reduce the monitoring frequency for a well-operated ground 
water system from quarterly routine monitoring to no less than annual 
monitoring, if the system demonstrates that it meets the criteria for 
reduced monitoring in paragraphs (e)(1) through (e)(3) of this section, 
except for a system that has been on increased monitoring under the 
provisions of paragraph (f) of this section. A system on increased 
monitoring under paragraph (f) of this section must meet the provisions 
of paragraph (g) of this section to go to quarterly monitoring and must 
meet the provisions of paragraph (h) of this section to go to annual 
monitoring.
    (1) The system has a clean compliance history for a minimum of 12 
months;
    (2) The most recent sanitary survey shows that the system is free 
of sanitary defects or has corrected all identified sanitary defects, 
has a protected water source, and meets approved construction 
standards; and
    (3) The State has conducted an annual site visit within the last 12 
months and the system has corrected all identified sanitary defects. 
The system may substitute a Level 2 assessment that meets the criteria 
in Sec.  141.859(b) for the State annual site visit.
    (f) Increased Monitoring Requirements for systems on quarterly or 
annual monitoring. A system on quarterly or annual monitoring that 
experiences any of the events identified in paragraphs (f)(1) through 
(f)(4) of this section must begin monthly monitoring the month 
following the event. A system on annual monitoring that experiences the 
event identified in paragraphs (f)(5) of this section must begin 
quarterly monitoring the quarter following the event. The system must 
continue monthly or quarterly monitoring until the requirements in 
paragraph (g) of this section for quarterly monitoring or paragraph (h) 
of this section for annual monitoring are met. A system on monthly 
monitoring for reasons other than those identified in paragraphs (f)(1) 
through (f)(4) of this section is not considered to be on increased 
monitoring for the purposes of paragraphs (g) and (h) of this section.
    (1) The system triggers a Level 2 assessment or two Level 1 
assessments under the provisions of Sec.  141.859 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 or one 
subpart Y monitoring violation and one Level 1 assessment under the 
provisions of Sec.  141.859 in a rolling 12-month period for a system 
on quarterly monitoring.
    (5) The system has one subpart Y monitoring violation for a system 
on annual monitoring.
    (g) Requirements for returning to quarterly monitoring. The State 
may reduce the monitoring frequency for a system on monthly monitoring 
triggered under paragraph (f) of this section to quarterly monitoring 
if the system meets the criteria in paragraphs (g)(1) and (g)(2) of 
this section.
    (1) Within the last 12 months, the system must have a completed 
sanitary survey or a site visit by the State or a voluntary Level 2 
assessment by a party approved by the State, be free of sanitary 
defects, and have a protected water source; and

[[Page 10359]]

    (2) The system must have a clean compliance history for a minimum 
of 12 months.
    (h) Requirements for systems on increased monitoring to qualify for 
annual monitoring. The State may reduce the monitoring frequency for a 
system on increased monitoring under paragraph (f) of this section if 
the system meets the criteria in paragraph (g) of this section plus the 
criteria in paragraphs (h)(1) and (h)(2) of this section.
    (1) An annual site visit by the State and correction of all 
identified sanitary defects. The system may substitute a voluntary 
Level 2 assessment by a party approved by the State for the State 
annual site visit in any given year.
    (2) The system must have in place or adopt one or more additional 
enhancements to the water system barriers to contamination in 
paragraphs (h)(2)(i) through (h)(2)(v) of this section.
    (i) Cross connection control, as approved by the State.
    (ii) An operator certified by an appropriate State certification 
program or regular visits by a circuit rider certified by an 
appropriate State certification program.
    (iii) Continuous disinfection entering the distribution system and 
a residual in the distribution system in accordance with criteria 
specified by the State.
    (iv) Demonstration of maintenance of at least a 4-log removal or 
inactivation of viruses as provided for under Sec.  141.403(b)(3).
    (v) Other equivalent enhancements to water system barriers as 
approved by the State.
    (i) Seasonal systems. (1) Beginning April 1, 2016, all seasonal 
systems must demonstrate completion of a State-approved start-up 
procedure, which may include a requirement for startup sampling prior 
to serving water to the public.
    (2) A seasonal system must monitor every month that it is in 
operation unless it meets the criteria in paragraphs (i)(2)(i) through 
(iii) of this section to be eligible for monitoring less frequently 
than monthly beginning April 1, 2016, except as provided under 
paragraph (c) of this section.
    (i) Seasonal systems monitoring less frequently than monthly must 
have an approved sample siting plan that designates the time period for 
monitoring based on site-specific considerations (e.g., during periods 
of highest demand or highest vulnerability to contamination). Seasonal 
systems must collect compliance samples during this time period.
    (ii) To be eligible for quarterly monitoring, the system must meet 
the criteria in paragraph (g) of this section.
    (iii) To be eligible for annual monitoring, the system must meet 
the criteria under paragraph (h) of this section.
    (3) The State may exempt any seasonal system from some or all of 
the requirements for seasonal systems if the entire distribution system 
remains pressurized during the entire period that the system is not 
operating, except that systems that monitor less frequently than 
monthly must still monitor during the vulnerable period designated by 
the State.
    (j) Additional routine monitoring the month following a total 
coliform-positive sample. Systems collecting samples on a quarterly or 
annual frequency must conduct additional routine monitoring the month 
following one or more total coliform-positive samples (with or without 
a Level 1 treatment technique trigger). Systems must collect at least 
three routine samples during the next month, except that the State may 
waive this requirement if the conditions of paragraph (j)(1), (2), or 
(3) of this section are met. Systems may either collect samples at 
regular time intervals throughout the month or may collect all required 
routine samples on a single day if samples are taken from different 
sites. Systems must use the results of additional routine samples in 
coliform treatment technique trigger calculations under Sec.  
141.859(a).
    (1) The State may waive the requirement to collect three routine 
samples the next month in which the system provides water to the public 
if the State, or an agent approved by the State, performs a site visit 
before the end of the next month in which the system provides water to 
the public. Although a sanitary survey need not be performed, the site 
visit must be sufficiently detailed to allow the State to determine 
whether additional monitoring and/or any corrective action is needed. 
The State cannot approve an employee of the system to perform this site 
visit, even if the employee is an agent approved by the State to 
perform sanitary surveys.
    (2) The State may waive the requirement to collect three routine 
samples the next month in which the system provides water to the public 
if the State has determined why the sample was total coliform-positive 
and has established that the system has corrected the problem or will 
correct the problem before the end of the next month in which the 
system serves water to the public. In this case, the State must 
document this decision to waive the following month's additional 
monitoring requirement in writing, have it approved and signed by the 
supervisor of the State official who recommends such a decision, and 
make this document available to the EPA and public. The written 
documentation must describe the specific cause of the total coliform-
positive sample and what action the system has taken and/or will take 
to correct this problem.
    (3) The State may not waive the requirement to collect three 
additional routine samples the next month in which the system provides 
water to the public solely on the grounds that all repeat samples are 
total coliform-negative. If the State determines that the system has 
corrected the contamination problem before the system takes the set of 
repeat samples required in Sec.  141.858, and all repeat samples were 
total coliform-negative, the State may waive the requirement for 
additional routine monitoring the next month.

Sec.  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 Sec.  141.2) and 
serving 1,000 or fewer people.
    (2) Following any total coliform-positive sample taken under the 
provisions of this section, systems must comply with the repeat 
monitoring requirements and E. coli analytical requirements in Sec.  
141.858.
    (3) Once all monitoring required by this section and Sec.  141.858 
for a calendar month has been completed, systems must determine whether 
any coliform treatment technique triggers specified in Sec.  141.859 
have been exceeded. If any trigger has been exceeded, systems must 
complete assessments as required by Sec.  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 
Sec.  141.21 that were in effect on March 31, 2016, unless any of the 
conditions in paragraph (e) of this section are triggered on or after 
April 1, 2016, or unless otherwise directed by the State.
    (2) Beginning April 1, 2016, the State must perform a special 
monitoring

[[Page 10360]]

evaluation during each sanitary survey to review the status of the 
system, including the distribution system, to determine whether the 
system is on an appropriate monitoring schedule. After the State has 
performed the special monitoring evaluation during each sanitary 
survey, the State may modify the system's monitoring schedule, as 
necessary, or it may allow the system to stay on its existing 
monitoring schedule, consistent with the provisions of this section. 
The State may not allow systems to begin less frequent monitoring under 
the special monitoring evaluation unless the system has already met the 
applicable criteria for less frequent monitoring in this section.
    (d) Criteria for reduced monitoring. (1) The State may reduce the 
monitoring frequency from monthly monitoring to no less than quarterly 
monitoring if the system is in compliance with State-certified operator 
provisions and demonstrates that it meets the criteria in paragraphs 
(d)(1)(i) through (d)(1)(iii) of this section. A system that loses its 
certified operator must return to monthly monitoring the month 
following that loss.
    (i) The system has a clean compliance history for a minimum of 12 
months.
    (ii) The most recent sanitary survey shows the system is free of 
sanitary defects (or has an approved plan and schedule to correct them 
and is in compliance with the plan and the schedule), has a protected 
water source and meets approved construction standards.
    (iii) The system meets at least one of the following criteria:
    (A) An annual site visit by the State that is equivalent to a Level 
2 assessment or an annual Level 2 assessment by a party approved by the 
State and correction of all identified sanitary defects (or an approved 
plan and schedule to correct them and is in compliance with the plan 
and schedule).
    (B) Cross connection control, as approved by the State.
    (C) Continuous disinfection entering the distribution system and a 
residual in the distribution system in accordance with criteria 
specified by the State.
    (D) Demonstration of maintenance of at least a 4-log removal or 
inactivation of viruses as provided for under Sec.  141.403(b)(3).
    (E) Other equivalent enhancements to water system barriers as 
approved by the State.
    (e) Return to routine monthly monitoring requirements. Systems on 
quarterly monitoring that experience any of the events in paragraphs 
(e)(1) through (e)(4) of this section must begin monthly monitoring the 
month following the event. The system must continue monthly monitoring 
until it meets the reduced monitoring requirements in paragraph (d) of 
this section.
    (1) The system triggers a Level 2 assessment or two Level 1 
assessments in a rolling 12-month period.
    (2) The system has an E. coli MCL violation.
    (3) The system has a coliform treatment technique violation.
    (4) The system has two subpart Y monitoring violations in a rolling 
12-month period.
    (f) Additional routine monitoring the month following a total 
coliform-positive sample. Systems collecting samples on a quarterly 
frequency must conduct additional routine monitoring the month 
following one or more total coliform-positive samples (with or without 
a Level 1 treatment technique trigger). Systems must collect at least 
three routine samples during the next month, except that the State may 
waive this requirement if the conditions of paragraph (f)(1), (2), or 
(3) of this section are met. Systems may either collect samples at 
regular time intervals throughout the month or may collect all required 
routine samples on a single day if samples are taken from different 
sites. Systems must use the results of additional routine samples in 
coliform treatment technique trigger calculations.
    (1) The State may waive the requirement to collect three routine 
samples the next month in which the system provides water to the public 
if the State, or an agent approved by the State, performs a site visit 
before the end of the next month in which the system provides water to 
the public. Although a sanitary survey need not be performed, the site 
visit must be sufficiently detailed to allow the State to determine 
whether additional monitoring and/or any corrective action is needed. 
The State cannot approve an employee of the system to perform this site 
visit, even if the employee is an agent approved by the State to 
perform sanitary surveys.
    (2) The State may waive the requirement to collect three routine 
samples the next month in which the system provides water to the public 
if the State has determined why the sample was total coliform-positive 
and has established that the system has corrected the problem or will 
correct the problem before the end of the next month in which the 
system serves water to the public. In this case, the State must 
document this decision to waive the following month's additional 
monitoring requirement in writing, have it approved and signed by the 
supervisor of the State official who recommends such a decision, and 
make this document available to the EPA and the public. The written 
documentation must describe the specific cause of the total coliform-
positive sample and what action the system has taken and/or will take 
to correct this problem.
    (3) The State may not waive the requirement to collect three 
additional routine samples the next month in which the system provides 
water to the public solely on the grounds that all repeat samples are 
total coliform-negative. If the State determines that the system has 
corrected the contamination problem before the system takes the set of 
repeat samples required in Sec.  141.858, and all repeat samples were 
total coliform-negative, the State may waive the requirement for 
additional routine monitoring the next month.

Sec.  141.856  Routine monitoring requirements for subpart H public 
water systems serving 1,000 or fewer people.

    (a) General. (1) The provisions of this section apply to subpart H 
public water systems of this part serving 1,000 or fewer people.
    (2) Following any total coliform-positive sample taken under the 
provisions of this section, systems must comply with the repeat 
monitoring requirements and E. coli analytical requirements in Sec.  
141.858.
    (3) Once all monitoring required by this section and Sec.  141.858 
for a calendar month has been completed, systems must determine whether 
any coliform treatment technique triggers specified in Sec.  141.859 
have been exceeded. If any trigger has been exceeded, systems must 
complete assessments as required by Sec.  141.859.
    (4) Seasonal systems. (i) Beginning April 1, 2016, all seasonal 
systems must demonstrate completion of a State-approved start-up 
procedure, which may include a requirement for start-up sampling prior 
to serving water to the public.
    (ii) The State may exempt any seasonal system from some or all of 
the requirements for seasonal systems if the entire distribution system 
remains pressurized during the entire period that the system is not 
operating.
    (b) Routine monitoring frequency for total coliforms. Subpart H 
systems of this part (including consecutive systems) must monitor 
monthly. Systems may not reduce monitoring.
    (c) Unfiltered subpart H systems. A subpart H system of this part 
that does not practice filtration in compliance with subparts H, P, T, 
and W must

[[Page 10361]]

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 Sec.  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 Sec.  
141.859 has been exceeded.

Sec.  141.857  Routine monitoring requirements for public water systems 
serving more than 1,000 people.

    (a) General. (1) The provisions of this section apply to public 
water systems serving more than 1,000 persons.
    (2) Following any total coliform-positive sample taken under the 
provisions of this section, systems must comply with the repeat 
monitoring requirements and E. coli analytical requirements in Sec.  
141.858.
    (3) Once all monitoring required by this section and Sec.  141.858 
for a calendar month has been completed, systems must determine whether 
any coliform treatment technique triggers specified in Sec.  141.859 
have been exceeded. If any trigger has been exceeded, systems must 
complete assessments as required by Sec.  141.859.
    (4) Seasonal systems. (i) Beginning April 1, 2016, all seasonal 
systems must demonstrate completion of a State-approved start-up 
procedure, which may include a requirement for start-up sampling prior 
to serving water to the public.
    (ii) The State may exempt any seasonal system from some or all of 
the requirements for seasonal systems if the entire distribution system 
remains pressurized during the entire period that the system is not 
operating.
    (b) Monitoring frequency for total coliforms. The monitoring 
frequency for total coliforms is based on the population served by the 
system, as follows:

  Total Coliform Monitoring Frequency for Public Water Systems Serving
                         More Than 1,000 People
------------------------------------------------------------------------
                                                       Minimum number of
                  Population served                    samples per month
------------------------------------------------------------------------
1,001 to 2,500.......................................                  2
2,501 to 3,300.......................................                  3
3,301 to 4,100.......................................                  4
4,101 to 4,900.......................................                  5
4,901 to 5,800.......................................                  6
5,801 to 6,700.......................................                  7
6,701 to 7,600.......................................                  8
7,601 to 8,500.......................................                  9
8,501 to 12,900......................................                 10
12,901 to 17,200.....................................                 15
17,201 to 21,500.....................................                 20
21,501 to 25,000.....................................                 25
25,001 to 33,000.....................................                 30
33,001 to 41,000.....................................                 40
41,001 to 50,000.....................................                 50
50,001 to 59,000.....................................                 60
59,001 to 70,000.....................................                 70
70,001 to 83,000.....................................                 80
83,001 to 96,000.....................................                 90
96,001 to 130,000....................................                100
130,001 to 220,000...................................                120
220,001 to 320,000...................................                150
320,001 to 450,000...................................                180
450,001 to 600,000...................................                210
600,001 to 780,000...................................                240
780,001 to 970,000...................................                270
970,001 to 1,230,000.................................                300
1,230,001 to 1,520,000...............................                330
1,520,001 to 1,850,000...............................                360
1,850,001 to 2,270,000...............................                390
2,270,001 to 3,020,000...............................                420
3,020,001 to 3,960,000...............................                450
3,960,001 or more....................................                480
------------------------------------------------------------------------

    (c) Unfiltered subpart H systems. A subpart H system of this part 
that does not practice filtration in compliance with subparts H, P, T, 
and W must collect at least one total coliform sample near the first 
service connection each day the turbidity level of the source water, 
measured as specified in Sec.  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 
Sec.  141.859 has been exceeded.
    (d) Reduced monitoring. Systems may not reduce monitoring, except 
for non-community water systems using only ground water (and not ground 
water under the direct influence of surface water) serving 1,000 or 
fewer people in some months and more than 1,000 persons in other 
months. In months when more than 1,000 persons are served, the systems 
must monitor at the frequency specified in paragraph (a) of this 
section. In months when 1,000 or fewer people are served, the State may 
reduce the monitoring frequency, in writing, to a frequency allowed 
under Sec.  141.854 for a similarly situated system that always serves 
1,000 or fewer people, taking into account the provisions in Sec.  
141.854(e) through (g).

Sec.  141.858  Repeat monitoring and E. coli requirements.

    (a) Repeat monitoring. (1) If a sample taken under Sec. Sec.  
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. Alternatively, the State may implement 
criteria for the system to use in lieu of case-by-case extensions. In 
the case of an extension, the State must specify how much time 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 sample containers of any size, as long as the total volume 
collected is at least 300 ml.
    (3) The system must collect an additional set of repeat samples in 
the manner specified in paragraphs (a)(1) through (a)(3) of this 
section if one or more repeat samples in the current set of repeat 
samples is total coliform-positive. The system must collect the 
additional set of repeat samples within 24 hours of being notified of 
the positive result, unless the State extends the limit as provided in 
paragraph (a)(1) of this section. The system must continue to collect 
additional sets of repeat samples until either total coliforms are not 
detected in one complete set of repeat samples or the system determines 
that a coliform treatment technique trigger specified in Sec.  
141.859(a) has been exceeded as a result of a repeat sample being total 
coliform-positive and notifies the State. If a trigger identified

[[Page 10362]]

in Sec.  141.859 is exceeded as a result of a routine sample being 
total coliform-positive, systems are required to conduct only one round 
of repeat monitoring for each total coliform-positive routine sample.
    (4) After a system collects a routine sample and before it learns 
the results of the analysis of that sample, if it collects another 
routine sample(s) from within five adjacent service connections of the 
initial sample, and the initial sample, after analysis, is found to 
contain total coliforms, then the system may count the subsequent 
sample(s) as a repeat sample instead of as a routine sample.
    (5) Results of all routine and repeat samples taken under 
Sec. Sec.  141.854 through 141.858 not invalidated by the State must be 
used to determine whether a coliform treatment technique trigger 
specified in Sec.  141.859 has been exceeded.
    (b) Escherichia coli (E. coli) testing. (1) If any routine or 
repeat sample is total coliform-positive, the system must analyze that 
total coliform-positive culture medium to determine if E. coli are 
present. If E. coli are present, the system must notify the State by 
the end of the day when the system is notified of the test result, 
unless the system is notified of the result after the State office is 
closed and the State does not have either an after-hours phone line or 
an alternative notification procedure, in which case the system must 
notify the State before the end of the next business day.
    (2) The State has the discretion to allow a system, on a case-by-
case basis, to forgo E. coli testing on a total coliform-positive 
sample if that system assumes that the total coliform-positive sample 
is E. coli-positive. Accordingly, the system must notify the State as 
specified in paragraph (b)(1) of this section and the provisions of 
Sec.  141.63(c) apply.

Sec.  141.859  Coliform treatment technique triggers and assessment 
requirements for protection against potential fecal contamination.

    (a) Treatment technique triggers. Systems must conduct assessments 
in accordance with paragraph (b) of this section after exceeding 
treatment technique triggers in paragraphs (a)(1) and (a)(2) of this 
section.
    (1) Level 1 treatment technique triggers.
    (i) For systems taking 40 or more samples per month, the system 
exceeds 5.0% total 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, as specified in Sec.  141.860(a).
    (ii) A second Level 1 trigger as defined in paragraph (a)(1) of 
this section, within a rolling 12-month period, unless the State has 
determined a likely reason that the samples that caused the first Level 
1 treatment technique trigger were total coliform-positive and has 
established that the system has corrected the problem.
    (iii) For systems with approved annual monitoring, a Level 1 
trigger in two consecutive years.
    (b) Requirements for assessments. (1) Systems must ensure that 
Level 1 and 2 assessments are conducted in order to identify the 
possible presence of sanitary defects and defects in distribution 
system coliform monitoring practices. Level 2 assessments must be 
conducted by parties approved by the State.
    (2) When conducting assessments, systems must ensure that the 
assessor evaluates minimum elements that include review and 
identification of inadequacies in sample sites; sampling protocol; 
sample processing; atypical events that could affect distributed water 
quality or indicate that distributed water quality was impaired; 
changes in distribution system maintenance and operation that could 
affect distributed water quality (including water storage); source and 
treatment considerations that bear on distributed water quality, where 
appropriate (e.g., small ground water systems); and existing water 
quality monitoring data. The system must conduct the assessment 
consistent with any State directives that tailor specific assessment 
elements with respect to the size and type of the system and the size, 
type, and characteristics of the distribution system.
    (3) Level 1 Assessments. A system must conduct a Level 1 assessment 
consistent with State requirements if the system exceeds one of the 
treatment technique triggers in paragraph (a)(1) of this section.
    (i) The system must complete a Level 1 assessment as soon as 
practical after any trigger in paragraph (a)(1) of this section. In the 
completed assessment form, the system must describe sanitary defects 
detected, corrective actions completed, and a proposed timetable for 
any corrective actions not already completed. The assessment form may 
also note that no sanitary defects were identified. The system must 
submit the completed Level 1 assessment form to the State within 30 
days after the system learns that it has exceeded a trigger.
    (ii) If the State reviews the completed Level 1 assessment and 
determines that the assessment is not sufficient (including any 
proposed timetable for any corrective actions not already completed), 
the State must consult with the system. If the State requires revisions 
after consultation, the system must submit a revised assessment form to 
the State on an agreed-upon schedule not to exceed 30 days from the 
date of the consultation.
    (iii) Upon completion and submission of the assessment form by the 
system, the State must determine if the system has identified a likely 
cause for the Level 1 trigger and, if so, establish that the system has 
corrected the problem, or has included a schedule acceptable to the 
State for correcting the problem.
    (4) Level 2 Assessments. A system must ensure that a Level 2 
assessment consistent with State requirements is conducted if the 
system exceeds one of the treatment technique triggers in paragraph 
(a)(2) of this section. The system must comply with any expedited 
actions or additional actions required by the State in the case of an 
E. coli MCL violation.
    (i) The system must ensure that a Level 2 assessment is completed 
by the State or by a party approved by the State as soon as practical 
after any trigger in paragraph (a)(2) of this section. The system must 
submit a completed Level 2 assessment form to the State within 30 days 
after the system learns that it has exceeded a trigger. The assessment 
form must describe sanitary defects detected, corrective actions 
completed, and a proposed timetable for any corrective actions not 
already completed. The assessment form may also note that no sanitary 
defects were identified.
    (ii) The system may conduct Level 2 assessments if the system has 
staff or management with the certification or qualifications specified 
by the State unless otherwise directed by the State.
    (iii) If the State reviews the completed Level 2 assessment and 
determines that the assessment is not sufficient (including any 
proposed timetable for any corrective actions not already completed), 
the State must consult with the system. If the State requires revisions 
after consultation, the system must submit a revised assessment form to 
the State on an agreed-upon schedule not to exceed 30 days.
    (iv) Upon completion and submission of the assessment form by the 
system, the State must determine if the system

[[Page 10363]]

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 timetable approved by the 
State in consultation with the system. The system must notify the State 
when each scheduled corrective action is completed.
    (d) Consultation. At any time during the assessment or corrective 
action phase, either the water system or the State may request a 
consultation with the other party to determine the appropriate actions 
to be taken. The system may consult with the State on all relevant 
information that may impact on its ability to comply with a requirement 
of this subpart, including the method of accomplishment, an appropriate 
timeframe, and other relevant information.

Sec.  141.860  Violations.

    (a) E. coli MCL Violation. A system is in violation of the MCL for 
E. coli when any of the conditions identified in paragraphs (a)(1) 
through (a)(4) of this section occur.
    (1) The system has an E. coli-positive repeat sample following a 
total coliform-positive routine sample.
    (2) The system has a total coliform-positive repeat sample 
following an E. coli-positive routine sample.
    (3) The system fails to take all required repeat samples following 
an E. coli-positive routine sample.
    (4) The system fails to test for E. coli when any repeat sample 
tests positive for total coliform.
    (b) Treatment technique violation. (1) A treatment technique 
violation occurs when a system exceeds a treatment technique trigger 
specified in Sec.  141.859(a) and then fails to conduct the required 
assessment or corrective actions within the timeframe specified in 
Sec.  141.859(b) and (c).
    (2) A treatment technique violation occurs when a seasonal system 
fails to complete a State-approved start-up procedure prior to serving 
water to the public.
    (c) Monitoring violations. (1) Failure to take every required 
routine or additional routine sample in a compliance period is a 
monitoring violation.
    (2) Failure to analyze for E. coli following a total coliform-
positive routine sample is a monitoring violation.
    (d) Reporting violations. (1) Failure to submit a monitoring report 
or completed assessment form after a system properly conducts 
monitoring or assessment in a timely manner is a reporting violation.
    (2) Failure to notify the State following an E. coli-positive 
sample as required by Sec.  141.858(b)(1) in a timely manner is a 
reporting violation.
    (3) Failure to submit certification of completion of State-approved 
start-up procedure by a seasonal system is a reporting violation.

Sec.  141.861  Reporting and recordkeeping.

    (a) Reporting. (1) E. coli.
    (i) A system must notify the State by the end of the day when the 
system learns of an E. coli MCL violation, unless the system learns of 
the violation after the State office is closed and the State does not 
have either an after-hours phone line or an alternative notification 
procedure, in which case the system must notify the State before the 
end of the next business day, and notify the public in accordance with 
subpart Q of this part.
    (ii) A system must notify the State by the end of the day when the 
system is notified of an E. coli-positive routine sample, unless the 
system is notified of the result after the State office is closed and 
the State does not have either an after-hours phone line or an 
alternative notification procedure, in which case the system must 
notify the State before the end of the next business day.
    (2) A system that has violated the treatment technique for 
coliforms in Sec.  141.859 must report the violation to the State no 
later than the end of the next business day after it learns of the 
violation, and notify the public in accordance with subpart Q of this 
part.
    (3) A system required to conduct an assessment under the provisions 
of Sec.  141.859 of this part must submit the assessment report within 
30 days. The system must notify the State in accordance with Sec.  
141.859(c) when each scheduled corrective action is completed for 
corrections not completed by the time of submission of the assessment 
form.
    (4) A system that has failed to comply with a coliform monitoring 
requirement must report the monitoring violation to the State within 10 
days after the system discovers the violation, and notify the public in 
accordance with subpart Q of this part.
    (5) A seasonal system must certify, prior to serving water to the 
public, that it has complied with the State-approved start-up 
procedure.
    (b) Recordkeeping. (1) The system must maintain any assessment 
form, regardless of who conducts the assessment, and documentation of 
corrective actions completed as a result of those assessments, or other 
available summary documentation of the sanitary defects and corrective 
actions taken under Sec.  141.858 for State review. This record must be 
maintained by the system for a period not less than five years after 
completion of the assessment or corrective action.
    (2) The system must maintain a record of any repeat sample taken 
that meets State criteria for an extension of the 24-hour period for 
collecting repeat samples as provided for under Sec.  141.858(a)(1) of 
this part.

PART 142--NATIONAL PRIMARY DRINKING WATER REGULATIONS 
IMPLEMENTATION

0
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.

0
22. Section 142.14 is amended by revising paragraph (a)(1)(iii) and 
adding a new paragraph (a)(10) to read as follows:

Sec.  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 Sec. Sec.  141.63, 
141.71, and 141.72 of this chapter and with the limits specified in 
subpart Y of this chapter.
* * * * *
    (10) Records of each of the following decisions made pursuant to 
the provisions of subpart Y of part 141 must be made in writing and 
retained by the State.
    (i) Records of the following decisions or activities must be 
retained for five years.
    (A) Sections 141.858(a), 141.853(c)(2), 141.856(c), and 141.857(c) 
of this chapter--Any case-by-case decision to waive the 24-hour time 
limit for collecting repeat samples after a total coliform-positive 
routine sample, or to extend the 24-hour limit for collection of 
samples following invalidation, or for an unfiltered subpart H system 
of this part to collect a total coliform sample following a turbidity 
measurement exceeding 1 NTU.
    (B) Sections 141.854(j) and 141.855(f) of this chapter--Any 
decision to allow a system to waive the requirement for

[[Page 10364]]

three routine samples the month following a total coliform-positive 
sample. The record of the waiver decision must contain all the items 
listed in those sections.
    (C) Section 141.853(c) of this chapter--Any decision to invalidate 
a total coliform-positive sample. If the decision to invalidate a total 
coliform-positive sample as provided in Sec.  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 Sec.  141.861(a)(2) of this chapter.
    (ii) Records of each of the following decisions must be retained in 
such a manner so that each system's current status may be determined:
    (A) Section 141.854(e) of this chapter--Any decision to reduce the 
total coliform monitoring frequency for a non-community water system 
using only ground water and serving 1,000 or fewer people to less than 
once per quarter, as provided in Sec.  141.854(e) of this chapter, 
including what the reduced monitoring frequency is. A copy of the 
reduced monitoring frequency must be provided to the system.
    (B) Section 141.855(d) of this chapter--Any decision to reduce the 
total coliform monitoring frequency for a community water system 
serving 1,000 or fewer people to less than once per month, as provided 
in Sec.  141.855(d) of this chapter, including what the reduced 
monitoring frequency is. A copy of the reduced monitoring frequency 
must be provided to the system.
    (C) Section 141.857(d) of this chapter--Any decision to reduce the 
total coliform monitoring frequency for a non-community water system 
using only ground water and serving more than 1,000 persons during any 
month the system serves 1,000 or fewer people, as provided in Sec.  
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.
* * * * *

0
23. Section 142.15 is amended by adding paragraph (c)(3) to read as 
follows:

Sec.  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 Sec. Sec.  141.855 and 
141.854 of this chapter, including the applicable date of the reduced 
monitoring requirement for each system.
* * * * *

0
24. Section 142.16 is amended by adding a new paragraph (q) to read as 
follows:

Sec.  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 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.

[[Page 10365]]

    (ix) Criteria for extending the 24-hour period for collecting 
repeat samples.--Under Sec. Sec.  141.858(a) and 141.853(c)(2) of this 
chapter, criteria for systems to use in lieu of case-by-case decisions 
to waive the 24-hour time limit for collecting repeat samples after a 
total coliform-positive routine sample, or to extend the 24-hour limit 
for collection of samples following invalidation. If the State elects 
to use only case-by-case waivers, the State does not need to develop 
and submit criteria.

0
25. Section 142.63 is amended by revising paragraph (b) to read as 
follows:

Sec.  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 Sec.  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 March 31, 2016, at 
which time the total coliform MCL is no longer applicable.

[FR Doc. 2012-31205 Filed 2-12-13; 8:45 am]
BILLING CODE P
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