Document ID: EPA-HQ-OW-2008-0878-0001
Agency: epa
Document Type: Proposed Rule
Title: National Primary Drinking Water Regulations: Revisions to the Total Coliform Rule
Posted Date: 2010-07-14T04:00Z

[Federal Register: July 14, 2010 (Volume 75, Number 134)]
[Proposed Rules]               
[Page 40925-41016]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy10-21]                         

[[Page 40925]]

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Part III

Environmental Protection Agency

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40 CFR Parts 141 and 142

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

[[Page 40926]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 141 and 142

[EPA-HQ-OW-2008-0878; FRL-9166-8]
RIN 2040-AD94

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed Rule.

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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is 
proposing revisions to the 1989 Total Coliform Rule. The proposed 
Revised Total Coliform Rule offers a meaningful opportunity for greater 
public health protection beyond the current Total Coliform Rule. The 
proposed revisions require systems that have an indication of coliform 
contamination in the distribution system to assess the problem and take 
corrective action that may reduce cases of illnesses and deaths due to 
potential fecal contamination and waterborne pathogen exposure. This 
proposal also updates provisions in other rules that reference 
analytical methods and other requirements in the current TCR (e.g., 
Public Notification and Ground Water Rules). These proposed revisions 
are in accordance with the Safe Drinking Water Act as amended, which 
requires EPA to review and revise, as appropriate, each national 
primary drinking water regulation promulgated under the Safe Drinking 
Water Act not less often than every six years. As with the current 
Total Coliform Rule, the proposed Revised Total Coliform Rule applies 
to all public water systems.

DATES: Comments must be received on or before September 13, 2010.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2008-0878, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Water Docket, Environmental Protection Agency, 
Mailcode: 4101T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, 
Attention Docket ID No. EPA-HQ-OW-2008-0878. In addition, please mail a 
copy of your comments on the information collection provisions to the 
Office of Information and Regulatory Affairs, Office of Management and 
Budget (OMB), Attn: Desk Officer for EPA, 725 17th St., NW., 
Washington, DC 20503.
     Hand Delivery: EPA Docket Center, (EPA/DC) EPA West, Room 
B102, 1301 Constitution Ave., NW., Washington, DC. Such deliveries are 
only accepted during the Docket's normal hours of operation, and 
special arrangements should be made for deliveries of boxed 
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2008-
0878. EPA's policy is that all comments received will be included in 
the public docket without change and may be made available online at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through http://
www.regulations.gov, or e-mail. The http://www.regulations.gov Web site 
is an ``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through http://www.regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, EPA recommends that you include your name 
and other contact information in the body of your comment and with any 
disk or CD-ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses. For additional information about EPA's public 
docket, visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some 
information is not publicly available, i.e., CBI or other information 
whose disclosure is restricted by statue. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in http://www.regulations.gov or in hard copy at the Water Docket, EPA 
Docket Center, EPA/DC, EPA West, Room B102, 1301 Constitution Ave., 
NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 
4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for the Water Docket is (202) 566-2426.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Regulated Categories and Entities

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

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                                                Examples of regulated
                 Category                             entities
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Industry..................................  Privately-owned community
                                             water systems (CWSs),
                                             transient non-community
                                             water systems (TNCWSs), and
                                             non-transient non-community
                                             water systems (NTNCWSs).
State, Tribal, and local governments......  Publicly-owned CWSs, TNCWSs,
                                             and NTNCWSs.
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    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.  141.850(b) 
of this proposed rule. If you have questions regarding the 
applicability of this action to a particular entity, consult the person 
listed in the preceding FOR FURTHER INFORMATION CONTACT section.

[[Page 40927]]

B. Copies of This Document and Other Related Information

    This document is available for download at http://www.epa.gov/
safewater/disinfection/tcr/. For other related information, see 
preceding discussion on docket.

Abbreviations Used in This Document

ADWR Airline Drinking Water Rule
AGI Acute Gastrointestinal Illness
AIDS Acquired Immune Deficiency Syndrome
AIP Agreement in Principle
AWWA American Water Works Association
ATP Alternative Test Procedure
AWOP Area Wide Optimization Program
BAT Best Available Technology
C Celsius
CA Corrective Action
CBI Confidential Business Information
CCR Consumer Confidence Report
CDC Centers for Disease Control and Prevention
CFR Code of Federal Regulations
COI Cost of Illness
CWS Community Water System
DBPs Disinfection Byproducts
DWC Drinking Water Committee
EA Economic Analysis
EC E. coli
EC-MUG EC Medium with MUG
EPA United States Environmental Protection Agency
ETV Environmental Technology Verification
FR Federal Register
GW Ground Water
GWR Ground Water Rule
GWS Ground Water System
GWUDI Ground Water Under the Direct Influence of Surface Water
HRRCA Health Risk Reduction and Cost Analysis
HUS Hemolytic Uremic Syndrome
ICR Information Collection Request
IESWTR Interim Enhanced Surface Water Treatment Rule
M Million
MCL Maximum Contaminant Level
MCLG Maximum Contaminant Level Goal
mg/L Milligrams per Liter
ml Milliliters
MOU Memorandum of Understanding
MRDL Maximum Residual Disinfectant Level
MUG 4-methylumbelliferyl-Beta-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
PN Public Notification
PWS Public Water System
RFA Regulatory Flexibility Act
RICP Research and Information Collection Partnership
RTCR Revised Total Coliform Rule
SAB Science Advisory Board
SBA Small Business Administration
SDWA Safe Drinking Water Act
SDWIS Safe Drinking Water Information System
SDWIS/FED Safe Drinking Water Information System Federal Version
SOP Standard Operating Procedure
Stage 1 DBPR Stage 1 Disinfectants and Disinfection Byproducts Rule
Stage 2 DBPR Stage 2 Disinfectants and Disinfection Byproducts Rule
SW Surface Water
SWTR Surface Water Treatment Rule
TC Total Coliforms
TCR Total Coliform Rule
TCRDSAC Total Coliform Rule/Distribution System Advisory Committee
TNCWS Transient Non-Community Water System
T&C Technology and Cost
US United States
UV Ultraviolet Radiation
WRF Water Research Foundation

Table of Contents

I. General Information
    A. Regulated Categories and Entities
    B. Copies of This Document and Other Related Information
II. Background
    A. Statutory Authority
    B. Total Coliform Rule Distribution System Advisory Committee 
(TCRDSAC)
    C. Other Outreach Processes
    D. Public Health Concerns Addressed by the Proposed Revised 
Total Coliform Rule
    1. Public health concerns, fecal contamination, and waterborne 
pathogens
    2. Indicators
    3. Occurrence of fecal contamination and waterborne pathogens
III. Proposed Revised Total Coliform Rule
    A. Proposed Rule Provisions and Rationale
    1. Terms used in the proposed RTCR
    2. MCLG and MCL for E. coli, and coliform treatment technique
    3. Monitoring
    4. Repeat samples
    5. Treatment technique requirements
    6. Violations
    7. Providing notification and information to the public
    8. Reporting and recordkeeping requirements for systems
    9. Analytical methods
    B. Proposed Compliance Date
    C. Links to Other Drinking Water Rule Requirements
    1. SWTR, Stage 1 and Stage 2 DBPRs, ADWR
    2. GWR
    3. Sanitary surveys
    D. Best Available Technology (BAT)
    1. Provisions
    2. EPA's rationale
    3. Request for comment
    E. Variances and Exemptions
    1. Provisions
    2. EPA's rationale
    3. Request for comment
    F. Request for Comment on Other Issues Related to the Proposed 
RTCR
    1. Consistency between the proposed RTCR and the GWR
    2. Storage tank inspection and cleaning
    3. States under EPA direct implementation
    G. Limitations to the Public Comment on the Proposed RTCR
IV. State Implementation
    A. State Special Primacy Requirements
    B. State Recordkeeping Requirements
    C. State Reporting Requirements
    D. Interim Primacy
    E. Request for Comment
V. Distribution System Research and Information Collection 
Activities
    A. Research and Information Collection Partnership
    B. Distribution System Optimization Activities
    C. Request for Comment
VI. Economic Analysis (Health Risk Reduction and Cost Analysis)
    A. Regulatory Options Considered
    B. Major Sources of Data and Information used in Supporting 
Analyses
    1. Safe Drinking Water Information System Federal Version data
    2. Six-Year Review 2 data
    3. Other information sources
    C. Occurrence and Predictive Modeling
    1. Model used for public water systems serving 4,100 or fewer 
people
    2. Model used for public water systems serving more than 4,100 
people
    D. Baseline Profiles
    E. Anticipated Benefits of the Proposed RTCR
    1. Relative risk analysis
    2. Changes in violation rates and corrective actions
    3. Nonquantifiable benefits
    F. Anticipated Costs of the Proposed RTCR
    1. Total annualized present value costs
    2. PWS costs
    3. State costs
    4. Nonquantifiable costs
    G. Potential Impact of the Proposed RTCR on Households
    H. Incremental Costs and Benefits
    I. Benefits from Simultaneous Reduction of Co-occurring 
Contaminants
    J. Change in Risk from Other Contaminants
    K. Effects of Fecal Contamination and/or Waterborne Pathogens on 
the General Population and Sensitive Subpopulations
    1. Risk to children, pregnant women, and the elderly
    2. Risk to immunocompromised persons
    L. Uncertainties in the Benefit and Cost Estimates for the 
Proposed RTCR
    1. Inputs and their uncertainties
    2. Sensitivity analysis
    M. Benefit Cost Determination for the Proposed RTCR
    N. Request for Comment on the Economic Analysis
VII. Statutory and Executive Order Review
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination with 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From 
Environmental Health Risks and Safety Risks

[[Page 40928]]

    H. Executive Order 13211: Actions That Significantly Affect 
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations
    K. Consultations with the Science Advisory Board, National 
Drinking Water Advisory Council, and the Secretary of Health and 
Human Services
    L. Impacts on Sensitive Subpopulations as Required by Section 
1412(b)(3)(C)(i) of the 1996 Amendments of the Safe Drinking Water 
Act (SDWA)
    M. Plain Language
VIII. References

II. Background

A. Statutory Authority

    The Safe Drinking Water Act (SDWA) requires the EPA to review and 
revise, as appropriate, each existing national primary drinking water 
regulation (NPDWR) at least once every six years (SDWA section 
1412(b)(9), 42 U.S.C. 300g-1(b)(9)). In 2003, EPA completed its review 
of the Total Coliform Rule (TCR) and 68 NPDWRs for chemicals that were 
promulgated prior to 1997 (USEPA 2003, 68 FR 42908, July 18, 2003). The 
purpose of the review was to identify new health risk assessments, 
changes in technology, and other factors that would provide a health-
related or technological basis to support a regulatory revision that 
would maintain or improve public health protection. In the Six-Year 
Review 1 determination published in July 2003 (USEPA 2003, 68 FR 42908, 
July 18, 2003), EPA stated its intent to revise the 1989 TCR (also 
referred to as the ``current TCR'').

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

    In June 2007, EPA established the Total Coliform Rule/Distribution 
System Advisory Committee (``TCRDSAC'' or ``the advisory committee'') 
in accordance with the provisions of the Federal Advisory Committee 
Act, 5 U.S.C. App.2, 9 (c), to provide recommendations to EPA on 
revisions to the 1989 TCR and on what information about distribution 
system issues is needed to better understand and address possible 
public health impacts from potential degradation of drinking water 
distribution systems (USEPA 2007a, 72 FR 35869, June 29, 2007). The 
decision to include a review of distribution system issues was made, in 
part, to address recommendations made by the Stage 2 Microbial and 
Disinfection Byproducts Federal Advisory Committee in December 2000 
(USEPA 2000b, 65 FR 83015, December 29, 2000). The TCRDSAC used 
available information to analyze options for revisions to the TCR. The 
TCRDSAC also considered research and information needed to better 
understand and address public health risks from contamination of 
distribution systems.
    The advisory committee consisted of representatives of EPA, State 
and local public health and regulatory agencies, consumer 
organizations, environmental organizations, local elected officials, 
Indian Tribes, and drinking water suppliers. A technical workgroup was 
also formed to provide the advisory committee with necessary technical 
support and analysis to facilitate the committee's discussions. The 
advisory committee met on 13 occasions between July 2007 and September 
2008. All advisory committee members agreed to and signed the final 
Agreement in Principle (AIP) in September 2008. All of the 
recommendations of the advisory committee are found in the signed AIP. 
Pursuant to the AIP, EPA agreed to propose revisions to the TCR that, 
to the maximum extent consistent with EPA's legal obligations, have the 
same substance and effect as the elements of the AIP. Each party 
represented on the advisory committee agreed in the AIP not to take any 
action to inhibit the adoption and implementation of final rule(s) to 
the extent it and the corresponding preamble have the same substance 
and effect as the elements of the AIP. EPA also agreed in the AIP to 
develop a Research and Information Collection Partnership (RICP) to 
``inform and support the drinking water community in developing future 
national risk management decisions pertaining to drinking water 
distribution systems'' by providing ``a formal process for systematic 
planning, implementation, analysis, and communication of distribution 
system research and information collection'' (USEPA 2008c). A 
discussion of the RICP can be found in section V of this preamble. The 
AIP and details about the advisory committee can be found at EPA's Web 
site at: http://www.epa.gov/safewater/disinfection/tcr/regulation_
revisions.html.
    In addition to the outreach mentioned above, EPA agreed to engage 
in various future stakeholder meetings at least annually, to which all 
advisory committee members and the public at large would be invited. In 
April 2009, EPA held its first annual stakeholder meeting to provide 
draft proposed regulation updates and an opportunity for stakeholders 
to provide feedback on the development of the proposed RTCR.

C. Other Outreach Processes

    In addition to consulting with the advisory committee, EPA engaged 
in several other activities as part of the Agency's outreach to 
stakeholders in developing the proposed RTCR. EPA held a technical 
workshop in Washington, DC, from January 30 to February 1, 2007, to 
discuss available information on the current TCR and available 
information regarding risks in distribution systems in support of 
revisions to the TCR. Other EPA outreach activities, namely the 
National Drinking Water Advisory Council consultation, Science Advisory 
Board consultation, and the Tribal consultation, are discussed in 
section VII of this preamble.

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

1. Public Health Concerns, Fecal Contamination, and Waterborne 
Pathogens
    The proposed RTCR aims to increase public health protection through 
the reduction of potential pathways of entry for fecal contamination 
into the distribution system. Since these potential pathways represent 
vulnerabilities in the distribution system whereby fecal contamination 
and/or waterborne pathogens, including bacteria, viruses and parasitic 
protozoa could possibly enter the system, the reduction of these 
pathways in general should lead to reduced exposure and associated risk 
from these contaminants. Fecal contamination and waterborne pathogens 
can cause a variety of illnesses, including acute gastrointestinal 
illness (AGI) with diarrhea, abdominal discomfort, nausea, vomiting, 
and other symptoms. Most AGI cases are of short duration and result in 
mild illness. Other more severe illnesses caused by waterborne 
pathogens include hemolytic uremic syndrome (HUS) (kidney failure), 
hepatitis, and bloody diarrhea (WHO 2004). Chronic disease such as 
irritable bowel syndrome, reduced kidney function, hypertension and 
reactive arthritis can result from infection by a waterborne agent 
(Clark et al. 2008).
    When humans are exposed to and infected by waterborne enteric 
pathogens, the pathogens become capable of reproducing in the 
gastrointestinal tract. As a result, healthy humans shed pathogens in 
their feces for a period ranging from days to weeks. This shedding of 
pathogens often occurs in the absence of any signs of clinical illness. 
Regardless of whether a pathogen causes clinical illness in the

[[Page 40929]]

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

III. Proposed Revised Total Coliform Rule

    The proposed RTCR maintains and strengthens the objectives of the 
current

[[Page 40930]]

TCR and is consistent with the recommendations in the AIP. The 
objectives are: (1) To evaluate the effectiveness of treatment, (2) to 
determine the integrity of the distribution system, and (3) to signal 
the possible presence of fecal contamination. The proposed revision 
better addresses these objectives by requiring systems that may be 
vulnerable to fecal contamination (as indicated by their monitoring 
results) to do an assessment, to identify whether any sanitary 
defect(s) is (are) present, and to correct the defects. Therefore, the 
Agency anticipates greater public health protection under the proposed 
RTCR compared to the current TCR because of its more preventive 
approach to identifying and fixing problems that affect or may affect 
public health.
    The following is an overview of the key provisions of the proposed 
RTCR:
     MCLG and MCL for E. coli and coliform treatment technique 
for protection against potential fecal contamination. The proposed RTCR 
establishes a maximum contaminant level goal (MCLG) and maximum 
contaminant level (MCL) for E. coli. It takes a preventive approach to 
protecting public health by establishing a coliform treatment technique 
for protection against potential fecal contamination. The treatment 
technique uses both total coliforms and E. coli monitoring results to 
start an evaluation process that, where necessary, will require the PWS 
to conduct follow-up corrective action that could prevent future 
incidences of contamination and exposure to fecal contamination and/or 
waterborne pathogens. See section III.A.2 of this preamble for a 
detailed discussion on the MCLG, MCL, and treatment technique 
requirements.
     Monitoring. As with the current TCR, PWSs will continue to 
monitor for total coliforms and E. coli according to a sample siting 
plan and schedule specific to the system.
    Sample siting plans under the proposed RTCR must continue to be 
representative of the water throughout the distribution system. Under 
the proposed RTCR, systems have the flexibility to propose repeat 
sample locations that best verify and determine the extent of potential 
contamination of the distribution system rather than having to sample 
within five connections upstream and downstream of the total coliform-
positive sample location. In lieu of proposing new repeat sample 
locations, the systems may stay with the default used under the current 
TCR of five connections upstream and downstream of the total coliform-
positive sample location.
    As with the current TCR, the proposed RTCR allows reduced 
monitoring for some small ground water systems. The proposed RTCR is 
expected to improve public health protection compared to the current 
TCR by requiring small ground water systems that are on or wish to 
conduct reduced monitoring to meet certain eligibility criteria. 
Examples of the criteria include a sanitary survey showing that the 
system is free of sanitary defects, a clean TCR compliance history for 
12 months, and a recurring annual site visit by the State and/or a 
voluntary Level 2 assessment for systems on annual monitoring.
    For small ground water systems, the proposed RTCR requires 
increased monitoring for high-risk systems that meet certain criteria 
such as unacceptable compliance history under the RTCR. The proposed 
RTCR specifies conditions under which systems will no longer be 
eligible for reduced monitoring and be required to return to routine 
monitoring or to monitor at an increased frequency.
    The proposed RTCR requires systems on a quarterly or annual 
monitoring frequency (applicable only to ground water systems serving 
1,000 or fewer people) to conduct additional routine monitoring the 
month following one or more total coliform-positive samples. Under the 
proposed RTCR, systems must collect at least three routine samples 
during the next month, unless the State waives the additional routine 
monitoring. This is a reduction in the required number of additional 
routine samples from the current TCR, which requires at least five 
routine samples in the month following a total coliform-positive sample 
for all systems serving 4,100 or fewer people.
    The current TCR requires all systems serving 1,000 or fewer people 
to collect at least four repeat samples while PWSs serving 1,000 people 
or greater to collect three repeat samples. The proposed rule requires 
three repeat samples after a routine total coliform-positive sample, 
regardless of the system type and size.
    See sections III.A.3 and III.A.4 of this preamble for detailed 
discussions of the routine monitoring and repeat sampling requirements 
of the proposed RTCR.
     Seasonal systems. The proposed RTCR establishes monitoring 
requirements for seasonal systems for the first time. Seasonal systems 
represent a special case in that the shutdown and start-up of these 
water systems present additional opportunities for contamination to 
enter or spread through the distribution system. Seasonal systems must 
demonstrate completion of a State-approved start-up procedure. In 
addition, they must designate the time period(s) for monitoring based 
on site-specific considerations (such as during periods of highest 
demand or highest vulnerability to contamination) in their State-
approved sample siting plan. See section III.A.3 of this preamble for a 
detailed discussion of seasonal systems.
     Assessment and corrective action. As part of a treatment 
technique, all PWSs are required to assess their systems when 
monitoring results show that the system may be vulnerable to 
contamination. Systems must conduct a simple self-assessment (Level 1) 
or a more detailed assessment (Level 2) depending on the severity and 
frequency of contamination. The system is responsible for correcting 
any sanitary defect(s) found through either a Level 1 or Level 2 
assessment. See section III.A.5 of this preamble for more discussion of 
the treatment technique requirement of the proposed RTCR.
     Violations and public notification. The proposed RTCR 
establishes an E. coli MCL violation, a treatment technique violation, 
a monitoring violation, and a reporting violation. Public notification 
is required for each type of violation, with the type of notification 
dependent on the degree of potential public health concern. This is 
consistent with EPA's current public notification requirements under 40 
CFR part 141 subpart Q. The proposed RTCR also modifies the public 
notification and Consumer Confidence Report language to reflect the 
construct of the proposed rule. See sections III.A.6 and III.A.7 of 
this preamble for detailed discussions of violations and public 
notification under the proposed RTCR.
     Transition to the RTCR. The proposed RTCR allows all 
systems to transition to the new rule at their current TCR monitoring 
frequency, including systems on reduced monitoring under the current 
TCR. States will then evaluate the monitoring frequency during each 
sanitary survey conducted after the compliance effective date of the 
RTCR. This process reduces State burden by not requiring the State to 
determine appropriate monitoring frequency at the same time as when the 
State is trying to adopt primacy, develop policies, and train their own 
staff and the PWSs in the State.
    The provisions of the proposed RTCR are contained in the new 40 CFR 
part 141 subpart Y, superseding 40 CFR 141.21 beginning three years 
following the publication of the final revised rule.

[[Page 40931]]

A. Proposed Rule Provisions and Rationale

1. Terms used in the proposed RTCR
    a. Provisions. i. Clean compliance history. For the purposes of the 
proposed RTCR, EPA is proposing to define ``clean compliance history'' 
as a record of no maximum contaminant level (MCL) violations under 40 
CFR 141.63; no monitoring violations under 40 CFR 141.21 or subpart Y; 
and no coliform treatment technique trigger exceedances or coliform 
treatment technique violations under subpart Y.
    ii. Sanitary defect. EPA is proposing to define ``sanitary defect'' 
as a ``defect that could provide a pathway of entry for microbial 
contamination into the distribution system or that is indicative of a 
failure or imminent failure in a barrier that is already in place'' 
(USEPA 2008c).
    iii. Seasonal systems. EPA is proposing to define a seasonal system 
as a non-community water system that is operated in three or fewer 
calendar quarters per calendar year.
    b. EPA's rationale. i. Clean compliance history. EPA is proposing a 
definition of ``clean compliance history'' because without a 
definition, the use of the phrase could result in multiple 
interpretations. Clean compliance history is one of the criteria a 
system must meet to be eligible for reduced monitoring. The advisory 
committee recommended this definition (USEPA 2008c, AIP p. 10).
    ii. Sanitary defect. The advisory committee recommended the 
definition of sanitary defect. The proposed RTCR takes a more 
preventive approach to protect public health by establishing a 
framework for the assessment of public water systems to identify 
sanitary defects and to correct them as appropriate. The first part of 
the proposed definition of a ``sanitary defect'' focuses on problems in 
the distribution system that may provide a pathway for contaminants to 
enter the distribution system and its implication for potential 
exposure to both microbial and chemical contaminants. The second part 
of the definition also recognizes the importance of having barriers in 
place to prevent the entry of microbial contaminants into the 
distribution system. Indications of failure or imminent failure of 
these barriers are defects that require corrective action.
    Sanitary defect is a term specific to the proposed RTCR assessment 
and corrective action provisions. Sanitary defects are not intended to 
be linked directly to ``significant deficiencies'' under the Interim 
Enhanced Surface Water Treatment Rule (IESWTR) (USEPA 1998b, 63 FR 
69389, December 16, 1998) and Ground Water Rule (GWR) (USEPA 2006c, 71 
FR 65574, November 8, 2006), although some problems could meet either 
definition. Nothing in this proposed rule is intended to limit the 
existing authorities of States under other regulations.
    The following is a list of examples of sanitary defects and defects 
in the distribution system coliform monitoring practices (USEPA 2008c, 
AIP Appendix Y, p. 41).
    Examples of sanitary defects:
     Cross connection and backflow issues such as a required 
backflow prevention device not in place or not operating properly; or 
an unprotected cross connection found.
     Operator issues such as failure to follow standard 
operating procedures (SOPs) that protect distribution system integrity 
and sanitary conditions.
     Distribution system issues such as inadequate inspection 
and maintenance of the distribution system; loss of distribution system 
integrity such as main breaks; failure to maintain adequate pressure; 
improper flushing operations; improper construction of new, replaced, 
or renovated lines; inadequate disinfection during and after repair/
replacement activities; or inability to maintain required residual 
throughout the distribution system.
     Storage issues such as overflow, vents, hatches, and other 
penetrations not properly configured, screened, or sealed; inadequate 
maintenance of storage facilities; or inadequate disinfection during 
and after repair/replacement activities.
     Disinfection issues such as inability to maintain required 
residual throughout the distribution system.
    iii. Seasonal systems. Seasonal systems fall under the broader 
category of non-community water systems (NCWS) and therefore are 
subject to provisions applicable to that category of systems. However, 
seasonal systems have unique characteristics and timetables that make 
them particularly susceptible to contamination. Seasonal systems 
represent a special case in that the shut down and start-up of the 
water system present opportunities for contamination to enter or spread 
through the distribution system. For example, loss of pressure after a 
system's shut down can lead to intrusion of contaminants. Microbial 
growth prior to start-up can result in biofilm formation, which can 
lead to the accumulation of contaminants. These systems are also more 
susceptible to contamination due to changes in the conditions of the 
source water (such as variable contaminant loading due to increased 
septic tank or septic field use), the seasonal nature of the demand, 
and the stress that the system experiences. As a result, the Agency is 
establishing a definition for seasonal systems and setting forth 
provisions that mitigate the risk associated with the unique 
characteristics of this type of system. The advisory committee 
recommended that such provisions pertain to seasonal systems. See 
section III.A.3 of this preamble for specific provisions that seasonal 
systems must meet.
    c. Request for comment. EPA requests comment on the proposed 
definitions and whether they work within the construct of the proposed 
RTCR. Specifically, EPA requests comment on the proposed definition of 
seasonal systems. The advisory committee recommended that seasonal 
systems be identified and be subject to additional regulatory 
requirements because the shutdown and startup of the system presents 
opportunities for contaminants to enter or spread through the 
distribution system. These results are possible in any system that 
shuts down and does not maintain adequate pressure throughout the 
distribution system. The AIP describes a seasonal system as ``one which 
operates less than four calendar quarters per year'' (USEPA 2008c). EPA 
has interpreted this to mean that a seasonal system is one which is 
shut down for at least one full calendar quarter (i.e., it operates in 
three or fewer calendar quarters). EPA requests comment on whether this 
proposed definition of ``seasonal system'' is adequate to address the 
concern that motivated the advisory committee's recommendation and is 
consistent with its intent. For example, a system that operated from 
March to October would operate in all four calendar quarters and would 
not be considered a seasonal system, but would be subject to the same 
possibility of distribution system intrusion as a seasonal system that 
operated April to November (i.e., in only three calendar quarters). 
Should EPA modify the definition to address this issue? If so, how 
should the definition be modified? Should systems that close for some 
specified period (e.g., 30 days, 60 days, 90 days) be subject to 
seasonal system requirements? What should that specified period be?
    Systems that operate intermittently (e.g., only on weekends or only 
when a camp is open) may also be subject to distribution system 
contamination due to lack of adequate pressure. Should this be 
addressed? If so, how should it be addressed--through regulation, 
guidance, or some other approach? Is

[[Page 40932]]

there a specific shutdown time that should be considered for 
intermittent systems in developing the approach and determining which 
systems should be included?
    In addition to the public health benefits associated with these 
requirements, EPA is aware of the burden that States will have in 
determining which systems must comply and in tracking compliance. 
Therefore, EPA requests comment on ways to reduce State burden and 
facilitate implementation of seasonal system provisions.
2. MCLG and MCL for E. coli, and Coliform Treatment Technique
    a. Provisions. The current TCR established a maximum contaminant 
level goal (MCLG) of zero for total coliforms (including fecal 
coliforms and E. coli) and an MCL for total coliforms. EPA is proposing 
in the RTCR to eliminate the MCLG for total coliforms (including fecal 
coliforms) and the MCL for total coliforms. Under the proposed RTCR, 
EPA establishes an MCLG of zero and an MCL for E. coli and a treatment 
technique for coliform. The proposed MCL for E. coli is based on the 
monitoring results for total coliforms and E. coli. A system is in 
compliance with the E. coli MCL unless any of the following conditions 
occur:
     A system has an E. coli positive repeat sample following a 
total 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.
    The proposed MCL is similar to the criteria that define the 
conditions (if exceeded) when a Tier 1 acute MCL violation occurs under 
the current TCR but with two modifications. First, the proposed MCL 
excludes fecal coliforms. Second, the proposed MCL also includes an 
additional condition by which a system violates the MCL, namely failing 
to collect all repeat samples following an initial E. coli-positive 
sample. 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 are a subset of total coliforms. EPA is also 
proposing a coliform treatment technique, which uses total coliforms 
and E. coli as indicators of a possible breach in the distribution 
system that could lead to fecal contamination.
    b. EPA's rationale. i. Inclusion of MCLG for E. coli and removal of 
MCLG for total coliforms (including fecal coliforms). EPA is proposing 
in the RTCR to include an MCLG of zero for E. coli and to remove the 
current MCLG of zero for total coliforms (including fecal coliforms). 
This is because E. coli is a more specific indicator of fecal 
contamination and potential harmful pathogens in drinking water than 
are total coliforms (including fecal coliforms). Many of the organisms 
detected by total coliform and fecal coliform methods are not of fecal 
origin and do not have any direct public health implication. See also 
the discussion of fecal coliforms in section III.A.9 of this preamble. 
New information has become available since promulgation of the current 
TCR in 1989 that indicates that measurement of fecal coliforms 
sometimes detects organisms that may not have any connection to fecal 
contamination (Edberg et al. 2000). An MCLG of zero for E. coli is more 
appropriate than an MCLG of zero for total coliforms (including fecal 
coliforms) since E. coli is a more specific indicator of the presence 
of fecal contamination.
    Total coliforms (including fecal coliforms) do not in and of 
themselves pose a public health risk, but they may indicate the 
presence of a pathway by which fecal contamination can occur. 
Therefore, the removal of the MCLG for total coliforms (including fecal 
coliforms) would prevent possible public confusion as a result of 
attributing greater public health significance to the presence of total 
coliforms than is warranted. EPA believes that the removal of the MCLG 
for total coliforms, along with the other proposed changes discussed in 
the succeeding paragraphs, leads to a rule that is more protective of 
public health, and is less confusing to the public. The proposed MCLG 
of zero for E. coli and the removal of the MCLG for total coliforms 
(including fecal coliforms) are also consistent with the recommendation 
made by the advisory committee in the AIP.
    ii. Inclusion of MCL for E. coli and removal of MCLs for total 
coliforms and fecal coliforms. EPA is proposing to include in the RTCR 
an MCL for E. coli because approved analytical methods continue to be 
available to measure the presence of E. coli in water samples, i.e., 
the presence of E. coli is technologically feasible to ascertain. 
Violation of the proposed MCL for E. coli signifies fecal contamination 
occurrence and a possible high risk of exposure to pathogens. EPA is 
proposing to eliminate the MCLs for total coliforms and fecal coliforms 
because under the proposal there is no longer an MCLG for either total 
coliforms or fecal coliforms, for the reasons explained earlier. The 
proposed MCL for E. coli is consistent with the recommendation made by 
the advisory committee in the AIP.
    iii. Coliform treatment technique. The 1996 SDWA amendments 
authorize EPA to promulgate a treatment technique in lieu of an MCL if 
EPA determines that ``it is not economically or technologically 
feasible to ascertain the level of the contaminant'' (SDWA 
1412(b)(7)(A)). While it is technologically feasible to ascertain 
levels of E. coli (i.e., analytical methods continue to be available to 
measure the presence of E. coli in water samples), because of the 
intermittent nature of fecal contamination, it is not economically 
feasible to ascertain the level of E. coli occurrence below which the 
water may be deemed safe. This is because it is not economically 
feasible to monitor E. coli with sufficient frequency to ensure such 
safety.
    Because total coliform bacteria are part of the soil ecosystem, 
positive samples are indicators of fecal contaminant entry into 
drinking water via a pathway from the soil. EPA is proposing a coliform 
treatment technique, supplemental to directly measuring E. coli, to 
provide additional protection against fecal contamination. Under the 
proposed coliform treatment technique, as specified in the AIP, total 
coliform-positive samples, in the absence of E. coli, are still 
indicators of an E. coli or other fecal contaminant pathway.
    A PWS that exceeds a specified frequency of total coliform 
occurrence must conduct a Level 1 or Level 2 assessment to determine if 
any sanitary defect(s) exist(s) and, if found, to correct the 
defect(s). In addition, under the proposed treatment technique 
requirements, a PWS that incurs an E. coli MCL violation must conduct a 
Level 2 assessment and take remedial action if any sanitary defects are 
found. See section III.A.5 of this preamble for a full discussion of 
conditions that trigger and define Level 1 and Level 2 assessments.
    The treatment technique requirements as proposed enhance public 
health protection beyond the E. coli MCL for the following reasons:
     The assessment and corrective action provisions of the 
treatment technique when the MCL for E. coli is exceeded require PWSs 
to investigate the potential causes of the fecal contamination and 
require timely remedial action if any sanitary defects

[[Page 40933]]

are found. Under the current TCR, there are no requirements for 
investigation and corrective action after an MCL exceedance. Without 
such a find-and-fix provision, the pathway for contamination may not be 
identified and eliminated as sampling alone may not be adequate to 
identify intermittent sources of fecal contamination. The assessment 
and corrective action provisions of the proposed rule increase the 
likelihood of finding and correcting any sanitary defect and reduce the 
chance of recurrence of fecal contamination in the future.
     Using total coliforms in addition to E. coli as an 
indicator to prompt assessment and corrective action increases the 
sensitivity for identifying potential pathways for contamination. As 
discussed in section II.D.2 of this preamble, the presence of total 
coliforms indicates the potential existence of a pathway through which 
fecal contamination could follow. The absence (versus the presence) of 
total coliforms in the distribution system indicates a reduced 
likelihood that fecal contamination and/or waterborne pathogens are 
occurring in the distribution system. Analyses from EPA's 2005 Six-Year 
Review 2 data (USEPA 2006b; USEPA 2010e) (see section VI.B of this 
preamble for details on the Six-Year Review 2 data) and from the 
proposed RTCR Economic Analysis (EA) occurrence modeling show that 
total coliform presence in drinking water is approximately 20 to 40 
times higher than E. coli occurrence in drinking water (see chapter 4 
of the Proposed RTCR EA (USEPA 2010a)). Similarly, under the current 
TCR, non-acute MCL (also referred to as monthly MCL) violations 
(informed by total coliform occurrence) occur roughly 10 times more 
often than acute MCL violations (informed by total coliform and E. coli 
occurrence, essentially equivalent to the occurrence that triggers an 
E. coli MCL violation under this proposed rule). Thus, including 
monitoring of total coliforms, as well as E. coli, as part of a 
treatment technique to indicate when systems must find and fix any 
sanitary defects, substantially increases the likelihood of identifying 
such defects.
     The proposed treatment technique was supported by the 
advisory committee and is consistent with the recommendations in the 
AIP. See AIP, pages 6-7.
    c. Request for comment. EPA requests comment on its proposal to 
eliminate the MCLG and MCL provisions for total coliforms and fecal 
coliforms and to include an MCLG and MCL for E. coli and coliform 
treatment technique provisions based on monitoring for total coliforms 
and E. coli. EPA also requests comment on its proposed definition of 
the E. coli MCL.
3. Monitoring
    a. Provisions. As with the current TCR, the proposed RTCR requires 
all PWSs to collect and test samples for total coliforms and E. coli 
according to a sample siting plan and schedule specific to the system. 
Under the proposed RTCR, all PWSs are still required to take repeat 
samples within 24 hours of learning of any routine monitoring sample 
that is total coliform-positive. PWSs must comply with the repeat 
monitoring requirements and E. coli analytical requirement, discussed 
in detail in section III.A.4 of this preamble. All samples taken for 
proposed RTCR compliance (routine and repeat) may occur at a customer's 
premises, dedicated sampling station, or other designated compliance 
sampling location.
    Under the proposed RTCR, system sample siting plans must include 
routine and repeat sample sites and any sampling points necessary to 
meet the Ground Water Rule (GWR) requirements. The sample siting plan 
is subject to State review and revision. The PWS may propose repeat 
monitoring locations that are expected to be representative of a 
pathway for contamination into the distribution system (for example, 
near a storage tank). Instead of identifying set repeat sampling 
locations (i.e., within five service connections upstream and 
downstream of the original sampling location that tested total 
coliform-positive), systems may elect to specify criteria for selecting 
their repeat sampling locations on a situational basis in a standard 
operating procedure (SOP), which is part of the sample siting plan. 
Upon State review, the PWS must demonstrate to the State's satisfaction 
that the sample siting plan remains representative of the water quality 
in the distribution system. The State may modify the SOP as needed. To 
address access issues, small systems must specify in their sampling 
plans where the two additional samples will be taken. The State may 
determine that monitoring at the entry point to the distribution system 
(especially for undisinfected ground water systems) is effective to 
differentiate between potential source water and distribution problems.
    Under the proposed RTCR, PWSs may take more than the minimum 
required number of routine samples and include the results in 
calculating whether the total coliform treatment technique trigger for 
conducting an assessment has been exceeded only if the samples are 
taken in accordance with the sample siting plan and are representative 
of water throughout the distribution system (see sections III.A.3 and 
III.A.5 of this preamble).
    EPA is not proposing to make substantive changes to the current TCR 
requirements for (1) special purpose samples, and (2) invalidation of 
total coliform samples. EPA is proposing a minor modification to the 
provision for special purpose samples by changing ``total coliform 
MCL'' to ``coliform treatment technique trigger.''
    The following are the proposed monitoring requirements for 
different categories of systems.
    i. Ground water NCWSs serving <= 1,000 people. (a). Routine 
monitoring. The proposed RTCR requires ground water NCWS serving 1,000 
or fewer people to routinely monitor each quarter for total coliforms 
and E. coli. Seasonal systems under this category must routinely 
monitor every month (seasonal systems are discussed later in this 
section).
    (b). Transition to the RTCR. The proposed RTCR requires all ground 
water NCWSs serving 1,000 or fewer people, including seasonal systems, 
to continue with their TCR monitoring schedules as of the compliance 
date of the RTCR, unless or until any of the conditions for increased 
monitoring discussed later on in this section are triggered on or after 
the compliance date or unless otherwise directed by the State, 
including through the special monitoring evaluation conducted under a 
sanitary survey. In addition, systems on annual monitoring, including 
seasonal systems, must have an initial annual site visit by the State 
within one year of the compliance date (or an annual voluntary Level 2 
assessment by a party approved by the State) and an annual site visit 
each year thereafter to remain on annual monitoring.
    This rule proposes that after the compliance date of the final 
RTCR, during each sanitary survey the State (which would be either EPA 
or a State that has received primacy for this rule) must perform a 
special monitoring evaluation to review the status of the water system, 
including the distribution system, to determine whether the system is 
on an appropriate monitoring schedule and modify the monitoring 
schedule as necessary. States must evaluate system factors such as the 
pertinent water quality and compliance history, the establishment and 
maintenance of contamination barriers, and other appropriate 
protections and validate the appropriateness of the

[[Page 40934]]

water system's existing monitoring schedule and modify as necessary. 
For seasonal systems on quarterly or annual monitoring, this evaluation 
must also include review of the approved sample siting plan which 
designates the time period(s) for monitoring based on site-specific 
considerations (such as during periods of highest demand or highest 
vulnerability to contamination). The system must collect compliance 
samples during these time periods.
    (c). Reduced monitoring. The State has the discretion to reduce the 
monitoring frequency for well-operated ground water NCWSs from the 
quarterly routine monitoring to no less than annual monitoring, if the 
water system can demonstrate that it meets the criteria for reduced 
monitoring provided in this section.
    To be eligible to qualify for and remain on annual monitoring after 
the compliance date, a ground water NCWS serving 1,000 or fewer people 
must meet all of the following criteria:
     The most recent sanitary survey shows the system is free 
of sanitary defects, has a protected water source and meets approved 
construction standards;
     The system must have a clean compliance history (no MCL 
violations or monitoring violations under the current TCR and/or 
proposed RTCR, no Level 1 or Level 2 trigger exceedances or treatment 
technique violations under the proposed RTCR) for a minimum of 12 
months. (For a more detailed discussion on Level 1 and Level 2 
triggers, see section III.A.5 of this preamble); and
     An initial site visit by the State within the last 12 
months to qualify for reduced annual monitoring, and recurring annually 
to stay on reduced annual monitoring; and correction of all identified 
sanitary defects. A voluntary Level 2 assessment by a party approved by 
the State may be substituted for the State annual site visit in any 
given year.
    (d). Increased monitoring. Ground water NCWS serving 1,000 or fewer 
people on quarterly or annual monitoring that experience any of the 
following events must begin monthly monitoring the month following the 
event:
     The system triggers a Level 2 assessment or two Level 1 
assessments in a rolling 12 month period;
     The system has an E. coli MCL violation;
     The system has a coliform treatment technique violation 
(for example, if the system fails to conduct a Level 1 assessment or 
correct for sanitary defects if required to do so); or
     The system on quarterly monitoring has two monitoring 
violations in a rolling 12-month period or system on annual monitoring 
has one monitoring violation.
    The system must continue monthly monitoring until the requirements 
in this section for returning to quarterly or annual monitoring are 
met.
    (e). Requirements for returning to quarterly monitoring. To be 
eligible to return to quarterly monitoring, ground water NCWSs serving 
1,000 or fewer people must meet all of the following criteria:
     Within the last 12 months, the system must have a 
completed sanitary survey or a site visit by the State or a voluntary 
Level 2 assessment by a party approved by the State. The system is free 
of sanitary defects, and has a protected water source; and
     The system has a clean compliance history (no E. coli MCL 
violations, Level 1 or 2 triggers, coliform treatment technique 
violations or monitoring violations) for a minimum of 12 months.
    (f). Requirements for returning to reduced annual monitoring. To be 
eligible to return to reduced annual monitoring after being placed on 
increased monitoring, the system must meet the criteria to return to 
routine quarterly monitoring plus the following criteria:
     An annual site visit (recurring) by the State and 
correction of all identified sanitary defects. An annual voluntary 
Level 2 assessment may be substituted for the State annual site visit 
in any given year; and
     The system must have in place or adopt one or more 
additional enhancements to the water system barriers to contamination 
as approved by the State. These measures could include but are not 
limited to the following:

--Cross connection control, as approved by the State;
--An operator certified by an appropriate State certification program, 
which may include regular visits by a circuit rider;
--Continuous disinfection entering the distribution system and a 
residual in the distribution system in accordance with criteria 
specified by the State; and
--Maintenance of at least a 4-log inactivation or removal of viruses 
each day of the month based on daily monitoring as specified in the GWR 
(with allowance for a 4-hour exception).
--Other equivalent enhancements to water system barriers as approved by 
the State.

    (g). Seasonal systems. The proposed rule requires all seasonal 
systems to demonstrate completion of a State-approved start-up 
procedure on and after the compliance date of the final RTCR. Seasonal 
systems may continue with their TCR monitoring frequency after the 
compliance date of the final RTCR unless or until any of the conditions 
for increased monitoring discussed previously are triggered on or after 
the compliance date or as directed by the State. Under the proposed 
RTCR, seasonal systems are required to take routine samples monthly.
    To be eligible for reduced monitoring after the compliance date, 
seasonal systems must meet the following criteria:
     The system must have an approved sample siting plan that 
designates the time period for monitoring based on site-specific 
considerations (e.g., during periods of highest demand or highest 
vulnerability to contamination). The system must collect compliance 
samples during this time period; and
     To be eligible for reduced quarterly monitoring, the 
system must also meet all the reduced monitoring criteria discussed in 
section III.A.3.a.i.(e) of this preamble, Requirements for returning to 
quarterly monitoring.
     To be eligible for reduced annual monitoring, the system 
must also meet all the reduced monitoring criteria discussed in section 
III.A.3.a.i.(f) of this preamble, Requirements for returning to reduced 
annual monitoring.
    (h). Additional routine monitoring. All systems collecting samples 
on a quarterly or annual frequency must conduct additional routine 
monitoring following a single total coliform-positive sample (with or 
without a Level 1 trigger event). The additional routine monitoring 
consists of three samples in the month following the total coliform-
positive sample at routine monitoring locations identified in the 
sample siting plan. This is a change from the current TCR additional 
routine monitoring requirement of taking a total of five samples the 
month following a total coliform-positive sample for systems that take 
four or fewer samples per month. In this proposal, consistent with the 
current TCR, the State may waive the additional routine monitoring 
requirement if:
     The State, or an agent approved by the State, performs a 
site visit before the end of the next month the system provides water 
to the public. Although a sanitary survey need not be performed, the 
site visit must be sufficiently detailed to allow the State to 
determine whether additional monitoring and/or any corrective action

[[Page 40935]]

is needed. The State cannot approve an employee of the system to 
perform this site visit, even if the employee is an agent approved by 
the State to perform sanitary surveys.
     The State has determined why the sample was total 
coliform-positive and establishes that the system has corrected the 
problem or will correct the problem before the end of the next month 
the system serves water to the public. In this case, the State must 
document this decision to waive the following month's additional 
monitoring requirement in writing, have it approved and signed by the 
supervisor of the State official who recommends such a decision, and 
make this document available to the EPA and public. The written 
documentation must describe the specific cause of the total coliform-
positive sample and what action the system has taken and/or will take 
to correct this problem.
    The State may not waive the requirement to collect three additional 
routine samples the next month in which the system provides water to 
the public solely on the grounds that all repeat samples are total 
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.
    ii. Ground water CWSs serving <= 1,000 people. (a). Routine 
monitoring. The proposed RTCR requires ground water CWSs serving 1,000 
or fewer people to routinely monitor each month for total coliforms and 
E. coli.
    The State may reduce the monitoring frequency for ground water CWS 
from the monthly routine monitoring to quarterly reduced monitoring if 
the water system can demonstrate that it meets the criteria for reduced 
monitoring provided later in this section
    (b). Transition to the RTCR. All ground water CWSs serving 1,000 or 
fewer people continue with their current TCR monitoring schedules 
unless or until any of the increased monitoring requirements in this 
section occur or as directed by the State.
    After the compliance date of the final RTCR, the State must 
determine whether the system is on an appropriate monitoring schedule 
by performing a special monitoring evaluation during each sanitary 
survey to review the status of the PWS, including the distribution 
system. The State must evaluate system factors such as the pertinent 
water quality and compliance history, the establishment and maintenance 
of barriers to contamination, and other appropriate protections to 
validate the water system's existing monitoring schedule or require 
more frequent monitoring.
    (c). Reduced monitoring. The State has the flexibility to reduce 
the monitoring frequency for well-operated ground water CWS from the 
monthly routine monitoring to no less than quarterly monitoring if the 
water system can demonstrate that it meets the criteria for reduced 
monitoring provided in this section.
    To be eligible for quarterly reduced monitoring, ground water CWSs 
serving 1,000 or fewer people on monthly monitoring after the 
compliance date must be in compliance with State-certified operator 
provisions and meet each of the following criteria:
     The most recent sanitary survey shows the system is free 
of sanitary defects (or has an approved plan and schedule to correct 
them), has a protected water source, and meets approved construction 
standards;
     The system must have a clean compliance history (no MCL 
violations or monitoring violations under the current TCR and/or 
proposed RTCR, no Level 1 or Level 2 trigger exceedances or treatment 
technique violations under the proposed RTCR) for a minimum of 12 
months; and
     The system must meet at least one of the following 
criteria:

--An annual site visit by the State or a voluntary Level 2 assessment 
by a party approved by the State or meeting criteria established by the 
State and correction of all identified sanitary defects (or an approved 
plan and schedule to correct them), or
--A cross connection control program, as approved by the State, or
--The system must maintain continuous disinfection entering the 
distribution system and a residual in the distribution system in 
accordance with criteria specified by the State, or
--The system must maintain at least a 4-log inactivation or removal of 
viruses each day of the month based on daily monitoring as specified in 
the GWR (with allowance for a 4-hour exception) (USEPA 2006c, 71 FR 
65574, November 8, 2006); or
--Other equivalent enhancements to water systems as approved by the 
State.
    (d). Return to routine monitoring requirements. When a system on 
quarterly monitoring experiences any of the following events the system 
must begin monthly monitoring:
     System triggers a Level 2 assessment or two Level 1 
assessments in a rolling 12 month period;
     System has an E. coli MCL violation;
     System has a coliform treatment technique violation (e.g., 
fails to conduct a Level 1 or Level 2 assessment or to correct for a 
sanitary defect if required to do so); or
     System has two routine monitoring violations in a rolling 
12-month period.
    The system must continue monthly monitoring until all the reduced 
monitoring requirements discussed previously in this section are met. A 
system that loses its certified operator must also return to monthly 
monitoring the month following the loss.
    (e). Additional routine monitoring. All systems collecting samples 
on a quarterly frequency must conduct additional routine monitoring 
following a single total coliform-positive sample (with or without a 
Level 1 trigger event). The additional routine monitoring consists of 
three samples in the month following the total coliform-positive sample 
at routine monitoring locations identified in the sample siting plan. 
The current TCR additional routine monitoring requirements consist of 
taking a total of five samples the month following a total coliform-
positive sample for systems that take four or fewer samples per month. 
In this proposal, consistent with the current TCR, the State may waive 
the additional routine monitoring requirement if:
     The State, or an agent approved by the State, performs a 
site visit before the end of the next month the system provides water 
to the public. Although a sanitary survey need not be performed, the 
site visit must be sufficiently detailed to allow the State to 
determine whether additional monitoring and/or any corrective action is 
needed. The State cannot approve an employee of the system to perform 
this site visit, even if the employee is an agent approved by the State 
to perform sanitary surveys.
     The State has determined why the sample was total 
coliform-positive and establishes that the system has corrected the 
problem or will correct the problem before the end of the next month 
the system serves water to the public. In this case, the State must 
document this decision to waive the following month's additional 
monitoring requirement in writing, have it approved and signed by the 
supervisor of the State official who recommends such a decision, and 
make this document available to the EPA and public. The written 
documentation must describe the specific cause of the total coliform-
positive sample and what

[[Page 40936]]

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 the coliform treatment technique 
requirements.
    iii. Subpart H systems of this part serving <= 1,000 people. The 
monitoring requirements for subpart H systems of this part (PWSs 
supplied by surface water source or ground water source under the 
direct influence of surface water (GWUDI)) serving 1,000 or fewer 
people remain the same as under the current rule (see Sec.  141.856). 
These systems are not eligible for reduced monitoring. In addition, the 
proposed rule requires all seasonal systems, on and after the 
compliance date of the final RTCR, to demonstrate completion of a 
State-approved start-up procedure.
    iv. PWSs serving > 1,000 people. The monitoring requirements for 
PWSs serving more than 1,000 people remain the same as under the 
current TCR (see Sec.  141.857), with the exception of the applicable 
revisions to the repeat sampling locations provided in Sec.  141.858 
and additional routine monitoring provisions. Systems on monthly 
monitoring are not required to take additional routine samples the 
month following a total coliform-positive sample. These systems are not 
eligible for reduced monitoring. In addition, the proposed rule 
requires all seasonal systems, on and after the compliance date of the 
final RTCR, to demonstrate completion of a State-approved start-up 
procedure.
    b. EPA's rationale. i. Sampling sites and monitoring plans. 
Consistent with current practice, the proposed RTCR requires systems to 
develop a sample siting plan that is representative of the water 
throughout the distribution system. EPA is proposing to maintain the 
provision from the current TCR that indicates that sample siting plans 
are subject to State review and revision. The advisory committee 
recommended that States review and revise sample siting plans 
consistent with current practice and that the State develops and 
implements a process to ensure the adequacy of sample siting plans 
including a periodic review. The advisory committee also recommended 
that specific elements be included in the sampling plans such as the 
routine and repeat sample sites and sampling locations necessary to 
meet the requirements of the GWR. Alternative repeat monitoring 
locations (e.g., at storage tanks and entry points to the distribution 
system) are subject to State approval. The system must demonstrate to 
the State's satisfaction that these alternative monitoring locations 
are representative of the water quality in the distribution system.
    By allowing systems to specify criteria for selecting their repeat 
sampling locations in their SOP instead of setting fixed repeat 
sampling locations, systems can provide a more flexible and more 
protective response. The system can focus the repeat samples at 
locations that will best verify and determine the extent of potential 
contamination of the distribution system based on specific situations. 
In addition, EPA is proposing to require State approval if a ground 
water system serving 1,000 or fewer people wants to use a single sample 
to meet both the repeat monitoring requirements of the RTCR and the 
source water monitoring requirements of the GWR (see section III.A.4 of 
this preamble for further discussion of this topic).
    EPA is proposing to allow the use of dedicated sampling locations 
for the following reasons:
     To reduce potential contamination of the taps. Utilities 
will have more control to prevent contamination of the tap by 
preventing its use by unauthorized persons and allowing no routine use 
of the tap except for sampling;
     To facilitate access to sampling taps. Currently systems 
may be constrained by where they sample, e.g., only at public buildings 
or in certain individual customer's houses.
     To improve sampling representation of the distribution 
system. Allowing dedicated sample taps in areas where systems have not 
been able to gain access will facilitate better sampling representation 
of the distribution system.
    ii. Ground water PWSs serving <= 1,000 people. (a). Routine 
monitoring. The advisory committee recommended that ground water NCWSs 
serving 1,000 or fewer people remain under a routine quarterly 
monitoring as provided in the current TCR. They believed that in 
conjunction with the assessment and corrective action requirements, 
public health protection would be maintained or improved without 
increasing sampling costs over current TCR requirements. The advisory 
committee also recognized that current sampling costs are not 
insignificant for small systems, and wanted to recognize the good 
performance of systems by allowing them to be able to continue to 
qualify for reduced monitoring, but under the more specific and 
rigorous criteria described previously. To continue to provide adequate 
health protection, systems on reduced monitoring must adhere to 
criteria that ensure that barriers are in place and are effective. 
Furthermore, systems with problems that may indicate poor system 
integrity, maintenance, or operations, or systems that fail to monitor, 
are triggered into monthly monitoring. This approach leverages the 
limited resources of these small ground water NCWSs and of States, so 
that systems with minimal problems can minimize their costs and States 
can focus their resources on systems needing the greatest attention, 
such as systems with problems or vulnerabilities.
    The advisory committee thought it best to continue with existing 
routine monthly monitoring requirements for ground water CWSs serving 
1,000 or fewer people in order to maintain the current levels of effort 
to identify potential problems. Since sanitary surveys are required 
under the GWR and these surveys provide substantial diagnostic value 
and corrective action response for problems identified, specifying 
higher routine monitoring frequency for these systems was not deemed 
necessary. These systems may also qualify for reduced monitoring if 
they meet certain criteria.
    (b). Transition to the RTCR. The advisory committee was concerned 
about the ability of the States and systems to adopt the new 
regulations and to make all the determinations that may be necessary to 
determine the appropriate monitoring frequency within three years of 
rule promulgation. Requiring significant changes in monitoring 
frequencies in a short period (i.e., without a transition period) could 
overwhelm State resources. The advisory committee recommended phasing 
in the requirements and using the sanitary survey process to facilitate 
a successful transition and implementation. The advisory committee, 
therefore, recommended that these systems continue with their current 
monitoring frequency during a transition period and that the State 
review the monitoring frequency to determine whether it is appropriate 
during each sanitary survey (USEPA 2008c, AIP p.9). This gives the 
systems the opportunity to address operation

[[Page 40937]]

and maintenance issues to maintain existing monitoring frequency or 
qualify for reduced monitoring. Systems on reduced TCR monitoring stay 
on reduced monitoring during the transition period if they continue to 
meet the reduced monitoring criteria. During the special monitoring 
evaluation conducted as part of the periodic sanitary survey, the State 
will determine whether the individual systems are on the proper 
monitoring schedule.
    (c) Reduced monitoring. The reduced monitoring requirements are 
intended to recognize that well-operated systems may be less vulnerable 
to contamination. Therefore, certain conditions are specified under 
which reduced monitoring could be allowed. These include a clean 
compliance history for a minimum of 12 months, and an annual visit from 
the State for systems taking one sample per year and correction of all 
identified sanitary defects. Ground water NCWSs serving 1,000 or fewer 
people, with a routine quarterly monitoring frequency, could qualify 
for reduced annual monitoring, while ground water CWSs serving 1,000 or 
fewer people, with a routine monthly monitoring frequency, could 
qualify for reduced quarterly monitoring.
    For NCWSs on annual monitoring, the advisory committee believed 
that requiring a system to have an annual site visit or a Level 2 
assessment provides at least an equivalent level of diagnosis of 
problems and vulnerabilities that might exist as compared to quarterly 
monitoring without an annual site visit. Several States have elected to 
conduct annual site visits while also doing annual monitoring for some 
NCWSs.
    (d) Increased monitoring requirements for NCWSs. The advisory 
committee wanted to recognize that if certain vulnerabilities are 
identified in a system, the system should be required to conduct more 
frequent monitoring to identify and correct its problems and better 
protect public health. Other than sanitary surveys or other site 
visits, monitoring is the primary means to identify pathways for 
potential contamination. If the system is deemed more vulnerable to 
such pathways, as indicated by the increased monitoring criteria, it 
must conduct more monitoring.
    (e) Requirements for returning to routine monitoring and reduced 
monitoring. The advisory committee believed that systems that address 
or correct vulnerabilities as indicated by a clean compliance history 
should be allowed to return to routine monitoring, and subsequently to 
reduced monitoring (for NCWS). This provision allows for reduced 
monitoring costs.
    (f) Seasonal systems. The advisory committee recognized that 
seasonal systems have unique characteristics that make them more 
susceptible to contamination. These systems do not maintain pressure 
while not in operation, which can result in the intrusion of 
contaminants. During the time when a seasonal system is not in 
operation, septic tank drain fields or other pollution sources may 
accumulate that could affect the conditions or quality of the source 
water (especially for intermittent contaminants) that infrequent 
monitoring may not be able to capture. If monitoring is done only at 
the start-up, there may not be enough time for the system to reach 
equilibrium (i.e., there might not be enough time to recognize if 
microorganisms from a septic tank moved to the wellhead in seasonally 
operated systems). Therefore, the proposed rule requires seasonal 
systems to monitor routinely at a monthly frequency. Seasonal systems 
can qualify for reduced monitoring if they meet certain criteria. For a 
seasonal system to be allowed to monitor at a reduced frequency, the 
proposed rule requires the system to have an approved sample siting 
plan that designates the time period for monitoring and takes into 
consideration site-specific conditions. A system on a reduced 
monitoring schedule (less than monthly) must collect samples when there 
is the greatest chance that contamination could be identified and, due 
to the variability in water demands, when systems could be most 
challenged.
    (g) Additional routine monitoring. EPA is proposing to retain the 
requirement of taking additional routine samples the month following a 
total coliform-positive sample for systems on quarterly or annual 
monitoring. The advisory committee recognized both the benefits and the 
limitations of additional routine monitoring. Additional routine 
samples are meant to enhance the diagnostic ability and supplement the 
infrequent routine monitoring of systems on quarterly or annual 
monitoring. Without the provision of additional monitoring, systems on 
annual or quarterly monitoring with a total coliform-positive sample 
would not take any samples the following month. The advisory committee 
believed that additional samples collected the following month are 
appropriate to help recognize the problem if it still persists.
    For systems required to take the additional routine samples the 
following month (i.e., systems on quarterly or annual monitoring), the 
proposed RTCR changes the requirement from taking a total of five 
routine samples to a requirement of just three routine samples. The 
advisory committee recognized that it is appropriate to drop from five 
to three samples the following month to reduce monitoring costs while 
still maintaining a substantial likelihood of identifying a problem if 
a problem persists. EPA recognizes that a reduction in the number of 
samples taken could also mean a reduction in the number of positive 
samples found. However, the reduction in the number of additional 
routine samples in conjunction with the new assessment and corrective 
action provisions of the proposed RTCR (discussed in section III.A.5 of 
this preamble) leads to a rule that is ultimately more protective of 
public health (i.e., more E. coli MCL violations being prevented) and 
improvement in water quality (i.e., decrease in the total coliform and 
E. coli-positive hit rates observed as shown by the Proposed RTCR EA 
occurrence modeling results). See chapter 6 of the Proposed RTCR EA 
(USEPA 2010a) for more details.
    For systems taking at least one sample monthly, the advisory 
committee recommended no additional routine samples for these systems 
for the following reason. Taking no additional routine samples the 
following month substantially reduces monitoring costs. The assessment 
and corrective action provisions will give systems the ability to 
identify and prevent the occurrence of problems. EA modeling results 
show that although there is a decrease in the number of E. coli MCL 
violations found with the decrease in the number of additional routine 
samples taken (i.e., going from five samples to one during the month 
following a total coliform-positive), the assessment and corrective 
action provisions lead to more E. coli MCL violations being prevented 
compared to the current TCR (see Exhibit 6-7 of the Proposed RTCR EA 
(USEPA 2010a) for more details).
    In addition, whenever a total coliform-positive occurs during 
routine sampling, there is also a requirement to conduct repeat 
sampling to determine the extent of contamination or if potential 
pathways to contamination persist. For small systems serving 1,000 or 
fewer people on monthly monitoring, if a repeat sample is total 
coliform-positive, at least a Level 1 assessment will be triggered. If 
a sanitary defect(s) is (are) found, the system is required to correct 
the sanitary defect(s).
    For systems on monthly monitoring, the assessment and corrective 
action provisions and the repeat sampling provisions mitigate the need 
for

[[Page 40938]]

additional routine sampling for the following month.
    iii. Subpart H systems of this part serving <= 1,000 people. EPA is 
not proposing to change the routine monitoring requirements for systems 
using surface water or GWUDI serving 1,000 or fewer people, which 
include not allowing reduced monitoring for these systems. Since 
systems using surface water or ground water under the influence of 
surface water tend to have much higher levels of contaminants in their 
source water, and in general have more complex operations than ground 
water systems, it is appropriate to allow reduced routine monitoring 
for ground water systems but not for subpart H systems of this part. 
The advisory committee recommended that no reduced routine monitoring 
provisions be allowed for subpart H systems of this part serving 1,000 
or fewer people.
    iv. Public water systems serving > 1,000 people. EPA is proposing 
to eliminate the additional routine samples the month following a total 
coliform-positive sample for PWSs serving between 1,000 and 4,100 
people for the same reasons discussed previously for small ground water 
systems monitoring monthly. PWSs serving more than 1,000 people are 
currently required to routinely monitor monthly (one to four samples 
per month depending on size) and continue to do so under the proposed 
RTCR.
    c. Request for comment. EPA requests comment on the proposed 
monitoring requirements for PWSs. Specifically, EPA requests comment on 
the following questions: Are there other issues that EPA should 
consider in its approach to help systems transition to the RTCR? Should 
EPA develop guidance that would help States identify seasonal systems 
and implement the RTCR requirements (e.g., suggestions for start up 
procedures and identifying vulnerable time periods)? What start-up 
procedures or other provisions regarding seasonal systems would be 
appropriate for inclusion in such guidance? EPA also requests comment 
on whether seasonal systems should be required to comply with State-
directed shut down procedures (in addition to start-up procedures).
    EPA requests comment on the following additional questions: Should 
daily measurement of chlorine residual count toward the maximum 
residual disinfectant level (MRDL) monitoring and be one of the 
criteria for reduced monitoring? Should NTNCWSs be required to comply 
with the CWS requirements (as they are in other rules such as DBP 
rules) since NTNCWSs serve the same people over time and include 
populations that may be at greater risk (e.g., schools, hospitals, 
nursing homes)? Will the reduced, routine, and increased monitoring 
requirements for NCWSs shift the fixed State resources from CWS 
oversight to NCWS oversight in those States with large numbers of 
NCWSs? If so, what might be done to limit the impact? Should EPA 
develop guidance on how to develop a sample siting plan? Should sample 
siting plans require State approval?
    EPA and the advisory committee did not identify any specific issues 
regarding consecutive systems in the proposed RTCR. EPA requests 
comment on whether there are such issues and how they should be 
addressed in the RTCR.
4. Repeat Samples
    a. Provisions. Under the proposed RTCR, all systems must take at 
least three repeat samples for each routine total coliform-positive 
sample. This is a change from the current TCR requirements where 
systems serving 1,000 or fewer people must collect at least four repeat 
samples while the rest of the systems must collect three repeat 
samples. EPA is not changing the following provisions: The 24-hour 
limit within which the system must collect the repeat samples; the 
authority of the State to extend this limit on a case-by-case basis; 
and the non-waiver by the State of the requirement for a system to 
collect repeat samples.
    In addition to taking repeat samples, systems must test each 
routine total coliform-positive sample for E. coli. They must also test 
any repeat total coliform-positive sample for E. coli. As with the 
current TCR, if E. coli is present, the system must notify the State 
the same day it learns of the positive result or by the end of the next 
business day at the latest. The proposed rule is not changing the 
provision that a State has the discretion to allow the system to forgo 
E. coli testing in cases where the system assumes that the total 
coliform-positive sample is E. coli-positive. If the State allows a 
system to forgo E. coli testing, the system must still notify the State 
and comply with the E. coli MCL requirements specified in Sec.  
141.858.
    As with the current TCR, the system must collect at least one 
repeat sample from the sampling tap where the original total coliform-
positive sample was taken. Unless different locations are specified in 
its sample siting plan, the system must also collect at least one 
repeat sample at a tap within five service connections upstream, and at 
least one repeat sample at a tap within five service connections 
downstream of the original sampling site. The State may waive the 
requirement to collect at least one repeat sample upstream or 
downstream of the original sampling site if the total coliform-positive 
sample is at the end of the distribution system, or one service 
connection away from the end of the distribution system. The system may 
also propose alternative repeat monitoring locations in its sample 
siting plan as discussed in this section.
    Under the proposed rule, ground water systems (GWSs) required to 
conduct triggered source monitoring under the GWR must take ground 
water source samples in addition to the repeat samples. However, a 
ground water system serving 1,000 or fewer people may use a repeat 
sample collected from a ground water source to meet both the repeat 
monitoring requirements of the proposed RTCR and the source water 
monitoring requirements of the GWR, but only if the State approves the 
use of a single sample to meet both rule requirements (i.e., a dual 
purpose sample) and the use of E. coli as a fecal indicator for source 
water monitoring. If the sample is E. coli-positive, the system 
violates the E. coli MCL under the proposed RTCR and must also comply 
with the GWR requirements following a fecal indictor-positive sample. 
These provisions are consistent with the GWR.
    If a system with a limited number of monitoring locations (such as 
a system with only one service connection or a campground with only one 
tap) takes more than one repeat sample at the triggered source water 
monitoring location, the system may reduce the number of additional 
source water samples by the number of repeat samples taken at that 
location that were not E. coli-positive. For example, if a system takes 
two dual purpose samples and one is E. coli-positive and the other is 
E. coli-negative, the system has an E. coli MCL violation under the 
proposed RTCR and is required to take four additional source water 
samples, rather than five, under the GWR (see 40 CFR 141.402(a)(3)). If 
the system takes more than one of these repeat samples at the triggered 
source water monitoring location and has more than one repeat sample 
that is E. coli-positive, then the system would have both an E. coli 
MCL violation under the proposed RTCR and a second fecal indicator-
positive source sample under the GWR. The system would then need to 
also comply with the treatment technique requirements under 40 CFR 
141.403.
    Under the proposed rule, the system must collect all repeat samples 
on the same day consistent with current TCR requirements. The State may 
allow

[[Page 40939]]

systems with a single service connection to collect the required set of 
repeat samples over a three-day period or to collect a larger volume 
repeat sample(s) in one or more sample containers of any size, as long 
as the total volume collected is at least 300 ml.
    The proposed RTCR is not changing the requirement that systems 
collect an additional set of repeat samples for each total coliform-
positive repeat sample. As with the original set of repeat samples, the 
system must collect the additional repeat samples within 24 hours of 
being notified of the positive result, unless the State extends the 
time limit. The system must repeat this process until either total 
coliforms are not detected in one complete set of repeat samples or the 
system determines that the coliform treatment technique trigger has 
been exceeded and notifies the State. After a trigger (see section 
III.A.5 of this preamble) is reached, the system is required to conduct 
only one round of repeat monitoring after each total coliform-positive 
or E. coli-positive routine sample. If a trigger is reached as a result 
of a repeat sample being total coliform- or E. coli-positive, no 
further repeat monitoring related to that sample is necessary.
    The proposed RTCR is also not changing the current TCR provision 
that a subsequent routine sample, which is within five service 
connections of the initial routine sample and is collected after an 
initial routine sample but before the system learns the initial routine 
sample is total coliform-positive, may count as a repeat sample 
instead.
    Results of all routine and repeat samples not invalidated by the 
State must be used to determine whether the coliform treatment 
technique trigger has been exceeded (see section III.A.5 of this 
preamble for a discussion of the coliform treatment technique 
triggers).
    b. EPA's rationale. i. Why EPA is maintaining a provision for 
repeat sampling. As with the current TCR, the proposed RTCR requires 
systems to take repeat samples after a total coliform-positive sample. 
EPA believes that sampling immediately after an initial positive sample 
(i.e., conducting repeat sampling) increases the likelihood of 
identifying the source and/or nature of the possible contamination. 
Analysis conducted by EPA indicated that once a total coliform-positive 
is found, there is a much greater likelihood of finding another total 
coliform-positive within a short period of time of the initial finding 
(see Exhibit III-1). Repeat sampling (when total coliform-positive) can 
indicate a current pathway for potential external contamination into 
the distribution system.
    EPA used the Six-Year Review 2 (USEPA 2010e) data to support 
statistical modeling which produced estimates of average occurrence of 
routine total coliform-positive samples and repeat total coliform-
positive samples and to characterize how occurrence varies from system 
to system. EPA's occurrence model assumes that, among similar systems, 
the positive rate for total coliforms in routine samples varies as a 
beta random variable. EPA used the Six-Year Review 2 data (USEPA 2010e) 
to estimate the parameters for the distribution of occurrences of 
routine and repeat total coliform-positive samples.
    Exhibit III-1 shows the relative probability of finding a total 
coliform-positive result from routine samples versus from repeat 
samples for 27 basic subsets of systems. The table combines regular 
routine and additional routine samples since no distinction was 
available for the Six-Year Review 2 data set (USEPA 2010e). The 
relative probability is defined as the ratio of the probability of 
getting a total coliform-positive result from a repeat sample to the 
probability of getting a total coliform-positive result from a routine 
sample.

  Exhibit III-1--Relative Probability of Total Coliform-Positive Samples in Routine Compared to Repeat Samples
----------------------------------------------------------------------------------------------------------------
                                                                  Average  pRTTC  Average  pRPTC   Ratio  pRPTC/
                         System type \1\                          \2\  (percent)  \3\  (percent)       pRTTC
----------------------------------------------------------------------------------------------------------------
TNCWS undisinfected GW:
    < 101.......................................................             4.8              28             5.9
    101-1,000...................................................             4.8              25             5.2
    1,001-4,100.................................................             2.5              17             6.9
NTNCWS undisinfected GW:
    < 101.......................................................             3.7              26             7.0
    101-1,000...................................................             2.7              26             9.6
    1,001-4,100.................................................             2.7              26             9.6
CWS undisinfected GW:
    < 101.......................................................             3.1              19             6.0
    101-1,000...................................................             2.7              19             7.1
    1,001-4,100.................................................             2.7              13             4.9
TNCWS disinfected GW:
    < 101.......................................................             2.3              14             6.2
    101-1,000...................................................             2.3              14             6.2
    1,001-4,100.................................................             2.3              14             6.2
NTNCWS disinfected GW:
    < 101.......................................................             1.6              11             6.7
    101-1,000...................................................             1.1              11             9.4
    1,001-4,100.................................................             1.1              11             9.4
CWS disinfected GW:
    < 101.......................................................             1.6             9.4             5.9
    101-1,000...................................................             1.2             9.4             7.6
    1,001-4,100.................................................            0.78             5.2             6.7
TNCWS SW:
    < 101.......................................................             2.3              14             6.2
    101-1,000...................................................             2.3              14             6.2
    1,001-4,100.................................................             2.3              14             6.2
NTNCWS SW:
    < 101.......................................................             1.6              11             6.7

[[Page 40940]]

    101-1,000...................................................             1.1              11             9.4
    1,001-4,100.................................................             1.1              11             9.4
CWS SW:
    < 101.......................................................             1.5             6.5             4.3
    101-1,000...................................................            0.95             6.5             6.8
    1,001-4,100.................................................            0.59             3.4             5.8
----------------------------------------------------------------------------------------------------------------
\1\ The following acronyms are used: (1) TNCWS Transient Non-Community Water System; (2) NTNCWS Non-Transient
  Non-Community Water System; (3) CWS Community Water System; (4) GW Ground Water; (5) SW Surface Water.
\2\ Average probability of a total coliform-positive from a routine total coliform sample.
\3\ Average probability of a total coliform-positive from a repeat total coliform sample.

    Exhibit III-1 shows that for any type and size of system, 
regardless of source water and disinfection practice, repeat total 
coliform samples (triggered by positive routine samples) are much more 
likely to be positive than are routine samples. For small (serving 100 
or fewer people) CWSs that provide undisinfected ground water, the 
average repeat total coliform-positive rate (19 percent) is about six 
times as great as the average routine total coliform-positive rate (3.1 
percent) for these systems. The ratio of repeat to routine total 
coliform-positive rates is greater for some sets of systems and smaller 
for others, but a ratio of at least six to one is common. Similar 
ratios of repeat to routine monitoring total coliform-positive rates 
were found for disinfected systems (ground water and surface water 
systems).
    Exhibit III-2 shows maximum likelihood distributions for the 
positive rates in routine and repeat samples of small TNCWSs (serving 
100 people or fewer) serving undisinfected ground water. The vertical 
axis shows cumulative probability, which is the fraction of systems 
having at most the corresponding horizontal axis value. Corresponding 
to 0.5 on the vertical axis is the median probability of a total 
coliform-positive. For example, for half of the systems, the 
probability of getting a total coliform-positive is 1.3 percent (i.e., 
0.013 probability of total coliform-positive on horizontal axis) for 
routine samples. This is the median probability of total coliform-
positive in routine samples. For repeat samples, the median probability 
of a positive is 17.5 percent (i.e., 0.175 probability of total 
coliform-positive on horizontal axis), which is about 13 times greater 
than that of the routine samples.

[[Page 40941]]

[GRAPHIC] [TIFF OMITTED] TP14JY10.000

    ii. Frequency of repeat samples. The advisory committee recommended 
that the current TCR requirement for systems serving more than 1,000 
people to take three repeat samples subsequent to a routine total 
coliform-positive be retained. The advisory committee recommended that 
systems serving 1,000 or fewer people also be required to take three 
repeat samples rather than the four required under the current TCR. 
This view is supported by analysis of repeat sample records from the 
Six-Year Review 2 data (USEPA 2010e).
    Repeat sampling helps utility operators to better understand the 
extent and duration of potential pathways of contamination into the 
distribution system. The Six-Year Review 2 data (USEPA 2010e) show that 
the average percentage of samples that are positive among repeat 
samples is much higher than that of routine samples, demonstrating that 
when operators are required to take a second look at their systems 
following the positive routine sample, they find, on average, a higher 
rate of coliform presence than during routine sampling. In other words, 
the high repeat total coliform-positive rate indicates the persistence 
of total coliforms at such locations in the distribution system.
    Further analysis of the data shows that for all PWSs serving 1,000 
or fewer people, two or more of the repeat samples are positive in 75 
percent of those instances in which there are any positive repeat 
samples, as shown in Exhibit III-3. For those 75 percent of instances, 
reducing the number of repeat samples from four to three would have no 
effect on the number of systems that would be triggered to conduct an 
assessment of the system under the proposed RTCR. In these cases, at 
least one of the remaining repeat samples would still be total 
coliform-positive, and only one positive repeat sample is required to 
trigger an assessment.
    The data show that one repeat sample is positive in 25 percent of 
the instances in which any of the four repeat samples is positive. For 
these instances, EPA estimates that if only three repeat samples had 
been taken instead of four, three out of four (or 75 percent) of these 
positive samples would still have been encountered.

[[Page 40942]]

   Exhibit III-3--Percentage of Instances With 1 or >1 Positive Repeat
  Samples Among Those Instances in Which >=1 Repeat Samples Is Positive
------------------------------------------------------------------------
                                             Number of positive repeat
                                                      samples
             System category             -------------------------------
                                                 1              > 1
------------------------------------------------------------------------
Undisinfected GWSs Serving <=1000.......             23%             77%
All PWSs Serving <=1000.................              25              75
------------------------------------------------------------------------
Note: Based on the analysis of Six-Year Review 2 dataset (USEPA 2010e)
  (described in chapter 4 of the Proposed RTCR EA (USEPA 2010a)). The
  total number of instances of positive repeat samples for undisinfected
  GWSs <=1000 is 2953, while all PWSs <=1000 have 3537 positive repeat
  samples.
Source: Proposed RTCR EA Appendix H (USEPA 2010a).

    When both of the two situations in which at least one repeat sample 
is positive (either one positive repeat sample or more than one 
positive repeat sample) are considered together, it is possible to 
estimate the overall effect of reducing the number of repeats from four 
to three, as presented in Exhibit III-4. The estimates in the table 
indicate that if the number of required repeats were reduced from four 
to three, there would still be almost as many (approximately 94 
percent) situations leading to an assessment being triggered for the 
system.

Exhibit III-4--Estimated Effects of Reducing Number of Required Repeat Samples for PWSs Serving <=1000 From 4 to
                                                        3
----------------------------------------------------------------------------------------------------------------
                                                                                                     Estimated
                                                                     Estimated                        overall
                                                   Percentage of   percentage of                   percentage of
                                                    events \1\      events that    Percentage of    events that
                                                  with exactly 1    would still     events \1\      would still
                                                  total coliform-  have 1 TC+ if    with >1 TC+    have >=1 TC+
                                                  positive (TC+)    1 out of 4     repeat sample   repeat sample
                                                   repeat sample  repeat samples                   if 1 out of 4
                                                                  were not taken                  repeat samples
                                                                                                  were not taken
----------------------------------------------------------------------------------------------------------------
                                                               A      B = A*0.75               C         D = B+C
----------------------------------------------------------------------------------------------------------------
Undisinfected GWSs Serving <=1000...............             23%             18%             77%           94.2%
All PWSs Serving <=1000.........................             25%             19%             75%           93.8%
----------------------------------------------------------------------------------------------------------------
\1\ Based on the analysis of the Six-Year Review 2 dataset (USEPA 2010e) (described in chapter 4 of the Proposed
  RTCR EA (USEPA 2010a)). The total number of events for undisinfected GWSs <=1000 is 2953, while all PWSs
  <=1000 have 3537 events.
Source: Proposed RTCR EA Appendix H (USEPA 2010a).

    Although dropping the required number of repeat samples from four 
to three means that some fraction of triggers may be missed, the other 
provisions of the proposed RTCR compensate for that change and, taken 
as a whole, the provisions of the proposed RTCR provide for greater 
protection of public health. One such provision includes enhanced 
consequences for monitoring violations. For example, systems that do 
not take all of their repeat samples under the proposed RTCR are 
triggered to conduct a Level 1 assessment. This permits an increase in 
public health protection over the current TCR because PWSs are required 
to assess their systems when monitoring results show that the PWS may 
be vulnerable to contamination (indicated by exceeding the trigger). 
Moreover, because of the substantial cost of this potential 
consequence, systems would be more likely to take all of their required 
repeat samples in the first place.
    It is important to point out that the majority of systems in this 
category are ground water systems treating to less than 4-log 
inactivation for viruses (see Exhibit 4.1 of the Proposed RTCR EA 
(USEPA 2010a)). Because of the triggered source monitoring provision 
under the GWR, these systems are required to collect a fecal indicator 
sample from the source water following a total coliform-positive sample 
in the distribution system in addition to the repeat samples. Under the 
existing GWR and TCR, systems taking four repeat samples are permitted 
to take the fourth repeat sample at the source water if they measure 
for E. coli as the fecal indicator and if they have State approval. 
Under the proposed RTCR, systems would continue to take this source 
water sample to comply with the GWR in addition to the required repeat 
samples in the distribution system to comply with the TCR. A positive 
sample at the source that is not also considered a repeat sample would 
not trigger an assessment under the proposed RTCR, but it would provide 
diagnostic value to the system in addition to triggering additional 
requirements under the GWR (i.e., corrective action or five additional 
source water fecal indicator samples).
    As under the existing GWR and current TCR, with State approval, 
ground water systems serving 1,000 or fewer people may use the sample 
taken at the location required for triggered source monitoring to also 
count toward the repeat monitoring requirements of the proposed RTCR. 
In this case, the State must also approve the use of E. coli as the 
fecal indicator under the GWR, and the system would comply with both 
GWR and the proposed RTCR when a total coliform-positive or E. coli-
positive sample occurs. The advisory committee recommended this 
flexibility to reduce the burden on small ground water systems that in 
most cases will have a very limited distribution system and only one 
source, consistent with the GWR.
    iii. Location of repeat samples. The advisory committee believed 
that

[[Page 40943]]

requiring repeat samples to be taken within five service connections up 
and downstream of the original total coliform-positive location can be 
difficult for systems to implement within the required 24 hours for a 
repeat sample because of issues such as access to the site. Therefore, 
the advisory committee recommended that systems be allowed to develop 
standard operating procedures (SOPs) as part of their sample siting 
plan to identify alternative monitoring sites and facilitate the 
identification of the source and extent of any problem. EPA is not 
requiring prior State approval for this provision since there is no 
reduction in monitoring and the SOP is expected to be used only by 
larger systems with the technical resources to justify alternative 
monitoring sites.
    The advisory committee also recommended that ground water systems 
have the flexibility to propose repeat sampling locations that 
differentiate potential source water and distribution system 
contamination (e.g., by sampling at entry points to the distribution 
system). See section III.A.3 of this preamble for additional discussion 
on this topic. Consistent with its understanding of the intent of the 
TCRDSAC, EPA has proposed that systems be allowed to exercise this 
flexibility only with prior State approval. State approval is required 
because this constitutes a reduction in monitoring (no separate 
triggered source water samples). EPA believes that this reduction in 
monitoring is appropriate only if the State determines that the dual 
purpose sample provides public health protection equivalent to that 
provided by separate repeat and source water samples. EPA believes that 
many ground water systems serving 1,000 or fewer people, such as 
systems with extensive distribution systems, will not be able to show 
that this reduction in monitoring (i.e., a loss of repeat sample that 
is near the total coliform-positive routine sample site, but not near 
the source water sample site) will provide public health protection 
equivalent to separate samples. EPA believes that systems with limited 
or no distribution systems are the best candidate for approval.
    c. Request for comment. EPA requests comment on the foregoing 
proposed repeat sampling requirements. Specifically, EPA requests 
comment on the proposal to allow samples taken at the ground water 
source to serve both as a triggered source sample under the GWR and as 
one of the repeat samples under the proposed RTCR. EPA is also 
requesting comment on whether systems should be allowed to use a dual 
purpose sample simply by including that in the sample siting plan, 
without prior State approval. Also, should systems using repeat 
monitoring sites more than five connections upstream or downstream from 
the routine total coliform-positive site be required to get prior State 
approval?
5. Treatment Technique Requirements
    a. Provisions. i. Coliform treatment technique triggers. The non-
acute MCL violation for total coliforms under the current TCR is 
effectively replaced by a coliform treatment technique involving 
monitoring for total coliforms under the proposed RTCR. Under the 
proposed treatment technique framework, the presence of total coliforms 
is used as an indicator of a potential pathway of contamination into 
the distribution system. As discussed in section III.A.2 of this 
preamble, the proposed RTCR eliminates the associated MCLG and MCL for 
total coliforms. The proposed revision specifies two levels of 
treatment technique triggers, Level 1 and Level 2, and their 
corresponding levels of response. Whether systems are required to 
conduct either a Level 1 or Level 2 assessment is based on the degree 
of potential pathway for contamination. The proposed rule further lays 
out an additional trigger for a Level 1 assessment and defines Level 2 
triggers that require a more in-depth examination of the system and its 
monitoring and operational practices.
    The system has exceeded the trigger immediately once any of the 
following conditions have been met:
    Level 1 treatment technique triggers:
     For systems taking 40 or more samples per month, the PWS 
exceeds 5.0 percent total coliform-positive samples for the month; or
     For systems taking fewer than 40 samples per month, the 
PWS has two or more total coliform-positive samples in the same month; 
or
     The PWS fails to take every required repeat sample after 
any single routine total coliform-positive sample.
    Level 2 treatment technique triggers:
     The PWS has an E. coli MCL violation (see section III.A.6 
of this preamble for description of what constitutes an E. coli MCL 
violation); or
     The PWS has a second Level 1 treatment technique trigger 
within a rolling 12-month period, unless the first Level 1 treatment 
technique trigger was based on exceeding the allowable number of total 
coliform-positive samples, the State has determined a likely reason for 
the total coliform-positive samples that caused the initial Level 1 
treatment technique trigger, and the State establishes that the system 
has fully corrected the problem.
     For PWSs with approved reduced annual monitoring, a Level 
1 treatment technique trigger in two consecutive years.
    ii. Assessment. EPA is proposing an assessment process in the RTCR 
to strengthen public health protection. Under the current TCR, a system 
is not required to perform an assessment following a monthly/non-acute 
MCL violation or an acute MCL violation. In contrast, the proposed RTCR 
requires systems to conduct assessments following the triggers 
specified above.
    EPA is proposing two levels of assessment based on the associated 
treatment technique trigger: Level 1 assessment for a Level 1 treatment 
technique trigger and Level 2 assessment for a Level 2 treatment 
technique trigger. At a minimum, both Level 1 and 2 assessments must 
include review and identification of the following elements:
     Inadequacies in sample sites, sampling protocol, and 
sample processing,
     Atypical events that may affect distributed water quality 
or indicate that distributed water quality was impaired,
     Changes in distribution system maintenance and operation 
that may affect distributed water quality, including water storage,
     Source and treatment considerations that bear on 
distributed water quality, where appropriate, and
     Existing water quality monitoring data.
    EPA expects that States will tailor specific assessment elements to 
the size and type of the system and that each public water system in 
turn will tailor its assessment activities based on the characteristics 
of its distribution system.
    Level 1 assessment:
    A Level 1 assessment must be conducted when a PWS exceeds one or 
more of the Level 1 treatment technique triggers specified above. Under 
the proposed rule, this self-assessment shall consist of a basic 
examination of the source water, treatment, distribution system and 
relevant operational practices. The PWS might look at conditions that 
could have occurred prior to and caused the total coliform-positive 
sample. Example conditions include treatment process interruptions, 
loss of pressure, maintenance and operation activities, recent 
operational changes, etc. In addition, the PWS might check the 
conditions of the following elements: sample sites, distribution 
system, storage tanks, source water, etc.
    The PWS must complete the Level 1 assessment as soon as practical 
after

[[Page 40944]]

notification of its monitoring results or failure to take repeat 
samples. The PWS must submit the completed assessment form to the State 
for review within 30 days after determination that the PWS has exceeded 
the trigger. Failure to submit the completed assessment form within 30 
days is a reporting violation. If the State determines that the 
assessment is insufficient, the State will consult with the PWS. If 
necessary after consultation, the PWS must submit a revised assessment 
to the State on an agreed upon schedule not to exceed 30 days from the 
date of the initial consultation.
    The completed assessment form must include assessments conducted, 
all sanitary defects identified (or a statement that no sanitary 
defects were identified), corrective actions completed, and a timetable 
for any corrective actions not already completed. Upon completion and 
submission of the assessment form by the PWS to the State, the State 
shall determine if the system has identified the likely cause(s) for 
the Level 1 treatment technique trigger and establish whether the 
system has corrected the problem(s).
    Level 2 assessment:
    A Level 2 assessment must be conducted when a PWS exceeds one or 
more of the Level 2 treatment technique triggers specified previously.
    A Level 2 assessment is a more comprehensive examination of the 
system, its monitoring and operational practices than the Level 1 
assessment. The level of effort and resources committed to undertaking 
a Level 2 assessment will be commensurate with the more comprehensive 
investigation and review of available information, and engage 
additional parties and expertise relative to the Level 1 assessment 
(see Appendix X of the AIP) (USEPA 2008c). Level 2 assessments must be 
conducted by a party approved by the State: The State itself, a third 
party, or the PWS where the system has staff or management with the 
required certification or qualifications specified by the State. If the 
PWS or a third party conducts the Level 2 assessment, the PWS or third 
party must follow the State requirements for conducting the Level 2 
assessment.
    The PWS must complete the Level 2 assessment as soon as practical 
after notification that the PWS has exceeded a Level 2 treatment 
technique trigger. The PWS must submit the completed assessment form to 
the State for review within 30 days after determination that the PWS 
has exceeded the trigger. Failure to submit the completed assessment 
form after the PWS properly conducts the assessment is a reporting 
violation. The State may direct expedited action or additional actions 
such as in the case of an E. coli MCL violation. If the State 
determines that the assessment is insufficient, the State will consult 
with the PWS. If necessary after consultation, the PWS must submit a 
revised assessment to the State on an agreed upon schedule not to 
exceed 30 days from the date of the initial consultation.
    The completed assessment form must include assessments conducted, 
all sanitary defects (or a statement that no sanitary defects were 
identified), corrective actions completed, and a timetable for any 
corrective actions not already completed. Upon completion and 
submission of the assessment form by the PWS to the State, the State 
shall determine if the system has identified the likely cause(s) for 
the Level 2 treatment technique trigger and, if so, establish that the 
system has corrected the problem(s).
    iii. Corrective action. The current TCR does not require systems 
that have MCL violations to perform corrective actions. Under this 
proposal, EPA is requiring PWSs to correct sanitary defects found 
through either a Level 1 or Level 2 assessment. Ideally, systems will 
be able to correct any sanitary defects found in the assessment within 
30 days and report that correction on the assessment form. When the 
correction of sanitary defects is not completed by the time the PWS 
submits the completed assessment form to the State, the PWS must 
complete the corrective action(s) on a schedule determined by the 
State. This schedule may be developed in consultation with the PWS. The 
schedule must include when the corrective action will be completed and 
any necessary milestones and temporary public health protection 
measures. The PWS must notify the State when each scheduled corrective 
action is completed.
    At any time during the assessment or corrective action phase, 
either the PWS or the State may request a consultation with the other 
entity to discuss and determine the appropriate actions to be taken. 
The system may consult with the State on all relevant steps that the 
system is considering to complete the corrective action, including the 
method of accomplishment, an appropriate timeframe, and other relevant 
information.
    E. coli detection in the distribution system indicates a public 
health hazard and can result in an E. coli MCL violation. Under the 
proposed rule, when an E. coli MCL violation has occurred, the system 
must complete a Level 2 assessment and corrective action must be 
implemented as soon as practical. The Agency encourages systems to 
promptly find the source of E. coli and fix the problem before the 
completed assessment form is due to the State.
    b. EPA's rationale. i. Coliform treatment technique. The advisory 
committee indicated that the conditions leading to a monthly/non-acute 
MCL under the current TCR should trigger an assessment under the RTCR 
for several reasons. First, the advisory committee recognized that 
presence of total coliform indicates the potential presence of a 
pathway for contamination from external sources such as source water or 
through a loss of distribution system integrity. The change to a 
coliform treatment technique construct that uses total coliforms as an 
indicator of distribution system integrity places the emphasis on 
systems to take more preventive actions to address problems. These 
actions would better protect public health than the additional 
monitoring with no corrective action that is required under the current 
TCR. To address the high and constant number of PWSs with violations 
over the years under the current TCR, the proposed changes would be 
more protective by requiring systems to correct deficiencies associated 
with the non-acute MCL (see Exhibit VI.1 in section VI.C.1 of this 
preamble). Second, the advisory committee indicated that the public 
notice associated with non-acute violations is confusing because the 
presence of total coliforms is not necessarily an indication of a 
potential public health threat; however, it is an indicator of a 
potential pathway for fecal contamination to enter into the 
distribution system. Under the treatment technique requirement, the 
presence of total coliforms (at the level equivalent to a non-acute 
violation) indicates a need to assess whether a problem exists. When a 
system fails to conduct the assessment, the system will then incur a 
violation and be required to issue public notification. If the system 
does conduct the assessment and satisfies the requirements of the 
treatment technique (including corrective action when a sanitary defect 
is identified), no public notification is required. Third, the 
occurrence of total coliforms in the context of the coliform treatment 
technique requirement continues to inform and further the original 
objectives of the TCR: to evaluate the effectiveness of treatment, 
determine the integrity of the distribution system, and signal the

[[Page 40945]]

possible presence of fecal contamination. Finally, total coliform 
presence indicates the potential presence of a pathway for contaminants 
from external sources such as source water or through a loss of 
distribution system integrity.
    ii. Assessment. The proposed rule requires assessments to ensure 
that specific action is taken to identify whether potential pathways of 
contamination into the distribution system exist. The advisory 
committee indicated that assessments are significant actions that 
protect public health. Under the current rule, when a system has a non-
acute MCL violation and if any subsequent sampling did not detect total 
coliform, the problem may persist due to the intermittent nature of 
total coliform and remain unaddressed. However, the absence of total 
coliform-positive samples subsequent to an initial positive finding is 
not a reliable indicator that a contamination pathway no longer exists. 
In contrast, the proposed revisions would ensure that systems examine 
and assess the cause of the total coliform occurrence (that is 
equivalent to the current non-acute MCL level) and take any corrective 
action if necessary.
    Under the proposed rule, the system will also be required to 
conduct an assessment if it fails to conduct repeat monitoring 
following an initial total coliform-positive sample result. As 
discussed in section III.A.4 of this preamble, repeat monitoring is 
critical in identifying the extent, source, and characteristics of 
fecal contamination in a timely manner. Since the revised rule proposes 
to eliminate additional routine monitoring for systems that monitor at 
least monthly and decrease the number of additional routine monitoring 
and repeat monitoring samples for the smallest systems, the need to 
conduct repeat monitoring is more crucial than ever in providing 
immediate and useful information needed to protect public health. The 
cost for collecting and analyzing a repeat sample would be considerably 
less than the cost for conducting a Level 1 assessment. EPA expects 
that systems will want to ensure that assessments are conducted only 
when potential problems may exist rather than for failure to take 
repeat samples.
    The proposed rule specifies two different levels of assessments--
Level 1 and Level 2--to recognize that a higher level of effort to 
diagnose a problem applies to situations of greater potential of public 
health concern such as repeated Level 1 triggers or an E. coli MCL 
violation. Level 2 assessments are conducted by a party approved by the 
State, which may be the PWS where it has staff or management with the 
certification or qualifications as determined by the State. The Level 2 
assessments may also be conducted by the State or a third party 
approved by the State.
    To make more transparent what the Level 1 and Level 2 assessments 
entail and to facilitate consistent implementation among States, the 
proposed rule specifies minimum elements for these assessments. The 
advisory committee recommended that the minimum elements identified 
previously in this preamble be included in the Level 1 and Level 2 
assessments to identify potential flaws in monitoring or specific 
pathways of contamination. Although the proposed RTCR specifies the 
same minimum elements for both the Level 1 and Level 2 assessments, the 
Level 2 assessment involves a more in-depth examination of these 
elements compared to a Level 1 assessment. Specific examples of how the 
Level 2 assessments are more in-depth than Level 1 assessments may be 
found in Appendix X of the AIP (USEPA 2008c).
    EPA recognizes that not every assessment will identify a sanitary 
defect or find a reason or cause for the presence of total coliforms. 
If no sanitary defect is identified, the system must document that fact 
in the completed assessment form and provide supporting evidence for 
this conclusion. EPA expects that only systems that adhere to proper 
procedures and standards set by the State are eligible to arrive at 
this determination, and only after providing sufficient supporting 
evidence.
    The advisory committee recommended that the Level 1 and Level 2 
assessments be conducted as soon as practical after the PWS receives 
notice that the system has exceeded the treatment technique trigger. 
The advisory committee also recommended that systems submit the 
completed assessment forms to the State within 30 days after 
determination that the PWS has exceeded the trigger. The rationale for 
the 30-day interval is to allow sufficient time for problem 
identification and potential remediation of the problem in conjunction 
with the follow-up assessment, in most cases.
    To help States and PWSs conduct assessments, EPA intends to develop 
a draft assessment and corrective action guidance manual and to make it 
available for public comment prior to promulgation of the final rule 
and to finalize the guidance manual after the rule is finalized.
    iii. Corrective action. The advisory committee recognized that not 
every assessment will identify a sanitary defect. However, the advisory 
committee recommended that the RTCR require all sanitary defects be 
corrected by the system in a timely manner. The system, in consultation 
with the State as needed, identifies and determines the specific 
corrective action.
    Under the proposed rule, the State may allow the PWS additional 
time to conduct the corrective action if needed. EPA recognizes that 
some systems may not be able to fix sanitary defects before submitting 
the completed assessment form within the 30-day interval due to the 
extent and cost of the corrective action. In such situations, EPA 
encourages the State and PWS to work together to determine the 
appropriate schedule for corrective actions (which may include 
additional or more detailed assessment or engineering studies) to be 
completed as soon as possible. The system must comply with the agreed 
upon schedule and notify the State when each scheduled corrective 
action is completed.
    Either the PWS or the State may request consultation with the other 
party to determine the appropriate actions to be taken. EPA is not 
requiring this to be a mandatory consultation to provide ease of 
implementation for States. In many cases, consultation may not be 
necessary because the type of corrective action for the sanitary defect 
will be clear and can be fixed right away (for example, replacement of 
a missing screen).
    c. Request for comment. EPA requests comment on the: (1) Proposed 
change from the non-acute MCL for total coliforms to a coliform 
treatment technique requirement that uses total coliforms as an 
indicator of a pathway of contamination; (2) proposed requirement for 
systems to conduct an assessment following a trigger condition; (3) 
proposed levels of assessment required; and (4) proposed requirement 
for systems to correct all sanitary defects found during an assessment. 
In addition, EPA requests comment on how to ensure that a Level 2 
assessment is more comprehensive than a Level 1 assessment (e.g., 
should a Level 2 assessment include additional elements such as asset 
management and capacity development?). Should EPA provide more detail, 
either in guidance or rule language, on the elements and differences 
between a Level 1 and Level 2 assessments? If in rule language, how 
should the rule language distinguish the two levels of assessments? 
Please provide examples. Additionally, should EPA provide additional 
guidance on how systems might address the situation where a Level 1 or 
Level 2 assessment

[[Page 40946]]

fails to identify any sanitary defects (i.e., the trigger event remains 
unexplained). If so, what should such guidance say?
6. Violations
    a. Provisions. EPA is proposing to modify the definition of the 
existing MCL violation, establish a treatment technique violation, and 
revise the monitoring and reporting violations. EPA is proposing that 
public notice be required for each type of violation (see section 
III.A.7 of this preamble for detail information on public 
notification).
    i. E. coli MCL violation. A violation of the E. coli MCL occurs 
when:
     A routine sample is total coliform-positive and one of its 
associated repeat samples is E. coli-positive; or
     A routine sample is E. coli-positive and one of its 
associated repeat samples is total coliform-positive; or
     A system fails to take all required repeat samples 
following a routine sample that is positive for E. coli; or
     A system fails to test for E. coli when any repeat sample 
tests positive for total coliforms.
    ii. Coliform treatment technique violation. A coliform treatment 
technique violation occurs when:
     A system fails to conduct a required assessment within 30 
days of notification of the system exceeding the trigger (see section 
III.A.5 of this preamble for conditions under which monitoring results 
trigger a required assessment); or
     A system fails to correct any sanitary defect found 
through either a Level 1 or 2 assessment within 30 days (see also 
section III.A.6 of this preamble) or in accordance with State-derived 
schedule.
    There would be no treatment technique violation associated solely 
with a system exceeding one or more action triggers (Level 1 or Level 2 
triggers).
    iii. Monitoring violation. Under the current TCR, a monitoring 
violation occurs when a system fails to comply with the total coliform 
monitoring requirements, including the sanitary survey requirement. 
Under the proposed RTCR, a monitoring violation occurs when a system 
fails to take every required routine or additional routine sample in a 
compliance period, or when it fails to test for E. coli following a 
routine sample that is total coliform-positive.
    In addition, if a system on quarterly monitoring has a monitoring 
violation in two or more quarters, or if a system on annual monitoring 
misses its annual monitoring, it must begin monthly monitoring until it 
meets criteria for less frequent monitoring. See section III.A.3 of 
this preamble for a detailed discussion on monitoring frequency.
    iv. Reporting violation. A reporting violation occurs when a system 
that properly conducts monitoring or an assessment fails to submit a 
monitoring report or a correctly completed assessment form by the 
required deadline. The PWS is responsible for reporting this 
information to the State regardless of any arrangement with a 
laboratory. A reporting violation also occurs when a system fails to 
notify the State following an E. coli-positive sample.
    b. EPA's rationale. To define violations, the advisory committee 
built upon the principles underlying the current TCR violations and 
current TCR public notification and suggested changes to improve public 
health protection where they saw a specific need. This proposal 
specifies responses to different degrees of potential public health 
concern. As described in the next section on providing information and 
notification to the public, Tier 1, Tier 2, and Tier 3 public notices 
are required following violations corresponding to the severity of each 
violation type.
    i. E. coli MCL violation. An E. coli MCL violation (which includes 
failure to take all required repeat samples following an E. coli-
positive sample) creates concern of an immediate potential public 
health threat. For this reason, an E. coli MCL violation is considered 
an acute violation requiring immediate response by the system. 
Including an E. coli MCL violation condition for systems failing to 
collect all repeat samples following an initial E. coli-positive sample 
enhances public health protection by preventing a system from incurring 
only a monitoring violation when there is an indication of fecal 
contamination. As discussed previously in section II.D of this 
preamble, the presence of E. coli indicates a pathway of fecal 
contamination and should be taken seriously. Systems need to follow up 
with repeat samples to characterize the extent and source of such 
contamination. Failure to take the required repeat samples following an 
initial E. coli-positive sample is not protective of public health and 
is a serious violation.
    ii. Coliform treatment technique violation. A coliform treatment 
technique violation occurs when a potential pathway of contamination in 
the distribution system is unexplored and/or uncorrected. Performing 
the Level 1 and 2 assessments and taking corrective action are 
essential aspects of compliance with the treatment technique. A system 
which neglects to perform the prescribed assessment or corrective 
action is in violation of the proposed RTCR's treatment technique 
requirements.
    iii. Monitoring violation and reporting violation. Monitoring and 
reporting violations occur when a system fails to comply with the 
routine monitoring requirements or when a system fails to submit 
monitoring reports or completed assessment forms. EPA believes that 
monitoring violations and reporting violations need to be addressed so 
that a system is held accountable to take actions to reduce public 
health risk, including regular monitoring of water quality.
    c. Request for comment. EPA requests comment on the proposed 
violation determinations.
7. Providing Notification and Information to the Public
    a. Provisions. To correspond to the changes in the proposed revised 
rule, EPA is proposing some modifications to the public notice (PN) 
requirements contained in 40 CFR part 141 subpart Q. Tier 1 PN is 
required for an E. coli MCL violation. Tier 2 PN is required for a 
treatment technique violation for failure to conduct assessments or 
corrective actions. Tier 3 PN is required for a monitoring violation or 
a reporting violation.
    In the current TCR, if a system has an acute MCL violation which is 
based on the presence of fecal coliforms or E. coli, or which is based 
on the system's failure to test for fecal coliforms or E. coli 
following a total coliform-positive repeat sample, the system is 
required to publish Tier 1 PN. Under the proposed RTCR, a system is 
required to publish Tier 1 PN when it has an E. coli MCL violation (see 
section III.A.6 of this preamble for what constitutes an E. coli MCL 
violation). In addition, the system will continue to be required to 
notify the State after learning of an E. coli-positive sample, as 
currently is required under the TCR. As mentioned earlier in section 
III.A.2 of this preamble, EPA is proposing to eliminate the MCL for 
fecal coliforms. Under the proposed rule, the standard health effects 
language, which is required to be included in all public notification 
actions, is modified to delete the reference to the fecal coliform MCL 
and fecal coliforms. The language for a non-acute violation under the 
current TCR is modified to apply to a violation of the assessments and 
corrective action requirements of the coliform treatment technique.
    In the current TCR, a system is required to publish a Tier 2 PN 
when the system has a non-acute MCL violation, which is based on total

[[Page 40947]]

coliform presence. Under the proposed rule, a system is required to 
publish a Tier 2 PN if the system violates the coliform treatment 
technique requirements. Also, EPA is proposing to modify the standard 
health effects language for coliform to emphasize the assessment and 
corrective action requirements of the proposed rule.
    In the current TCR, a system is required to publish a Tier 3 PN 
when the system has a monitoring or reporting violation. In the 
proposed rule, the Tier 3 PN requirements are changed to incorporate 
the recommendation in the AIP that monitoring violations be considered 
distinct from reporting violations under the proposed RTCR. Both types 
of violations require Tier 3 PN.
    Consumer confidence report (CCR) requirements are also modified. 
Health effects language for the CCR, which is identical to the health 
effects language required for PN, is updated in the same way as 
described for PN. In addition, the proposed RTCR removes the CCR 
requirements that require the inclusion of total numbers of positive 
samples, or highest monthly percentage of positive samples for total 
coliforms as well as total number of positive samples for fecal 
coliforms. These provisions are replaced by requirements to include the 
number of Level 1 and Level 2 assessments required and completed, the 
corrective actions required and completed, and the total number of 
positive samples for E. coli. Unchanged and consistent with existing 
provisions under the current TCR, a CWS may provide Tier 3 PN using the 
annual CCR.
    b. EPA's rationale. The proposed public notification requirements 
are consistent with the AIP language as well as with the tier system 
described in 40 CFR part 141 subpart Q. These changes are appropriate 
because some of the types of violations in the proposed RTCR are 
different from the current TCR. The standard health effects language 
for the public notification is also revised as appropriate given the 
changes to what constitutes a violation under the proposed RTCR.
    The proposed Tier 1 PN requirement for an E. coli MCL violation is 
consistent with the current TCR. Tier 1 PN is required for NPDWR 
violations and situations with significant potential to have serious 
adverse effects on human health as a result of short term exposure. The 
existing Tier 1 PN requires public notice as soon as possible but no 
later than 24 hours after the system learns of the violation. Exposure 
to E. coli in drinking water can possibly result in serious, acute 
health effects, such as diarrhea, cramps, nausea, headaches, or other 
symptoms and possible greater health risks for infants, young children, 
some of the elderly, and people with severely compromised immune 
systems.
    Tier 2 PN is required for all NPDWR violations and situations with 
potential to have serious adverse effects on human health not requiring 
Tier 1 PN. The system must provide public notice as soon as practical, 
but no later than 30 days after the system learns of the violation. A 
treatment technique violation under the proposed RTCR meets these 
criteria because it is an indication that the public water system 
failed to conduct an assessment or complete corrective action following 
identification of sanitary defects. Identification of a sanitary defect 
indicates that a problem may exist in the distribution system that has 
potential to cause public health concern.
    Tier 3 PN is required for all other NPDWR violations and situations 
not included in Tier 1 or Tier 2. The existing Tier 3 PN requires a 
system to provide public notice no later than one year after the system 
learns of the violation or situation or begins operating under a 
variance or exemption. Monitoring violations and reporting violations 
meet these criteria because, while they do represent a violation of the 
proposed RTCR, the risk to public health is not as clearly linked as 
those that are Tier 1 or 2. Therefore, EPA believes that a public 
notice given at least annually fulfills the public's right-to-know 
about these violations.
    Consumer confidence report requirements are updated to reflect the 
advisory committee's recommendations that total coliforms be used as an 
indicator to start an evaluation process that, where necessary, will 
require the PWS to correct sanitary defects. EPA believes it is most 
appropriate to inform the public about actions taken, in the form of 
assessments and corrective actions, since failure to conduct these 
activities lead to treatment technique violations under the proposed 
RTCR. Because the proposed RTCR no longer includes the total coliform 
MCL but now includes a trigger, EPA believes that systems no longer 
need to report the number of total coliform-positive samples via the 
CCR, since that could cause confusion or inappropriate changes in 
behavior among consumers. In addition, the CCR requirements will also 
reflect the removal of fecal coliform provisions under the proposed 
RTCR.
    c. Request for comment. EPA requests comment on whether the PN and 
CCR language revisions are consistent with the provisions of the 
proposed RTCR that reflect the use of total coliforms as an indicator 
within a coliform treatment technique. Since EPA is not aware of health 
effects resulting solely from exposure to total coliforms, the proposed 
RTCR eliminates the public notification requirement for detection of 
total coliforms, but provides for public notification upon detection of 
E. coli, and for violation of the coliform treatment technique. The 
Agency does request comment, however, on the loss of information to 
consumers resulting from elimination of public notification 
requirements following positive sample results for total coliforms. EPA 
also requests comment on whether the proposed RTCR should require 
special notice to the public of sanitary defects, in addition to the PN 
requirements, similar to the GWR special notice requirements. This 
would be consistent with current requirements for other regulations 
that limit pathogens in ground water systems. Under 40 CFR 
141.403(a)(7)(i), a CWS must inform the public of the significant 
deficiency and/or fecal indicator-positive sample. The CWS must 
continue to inform the public annually until the significant deficiency 
is corrected or the fecal contamination in the ground water source has 
been determined by the State to be corrected. Under 40 CFR 
141.403(a)(7)(ii), an NCWS that receives notice from the State of a 
significant deficiency must inform the public of any significant 
deficiency that has not been corrected within 12 months of being 
notified by the State, or earlier if directed by the State. The NCWS 
must continue to inform the public annually until the significant 
deficiency is corrected.
8. Reporting and Recordkeeping Requirements for Systems
    a. Provisions. i. Reporting. In addition to the existing general 
reporting requirements provided in 40 CFR 141.31, the proposed RTCR 
requires a PWS to:
     Notify the State no later than the end of the next 
business day after it learns of an E. coli-positive sample.
     Report to the State an E. coli MCL violation no later than 
the end of the next business day after learning of the violation. The 
PWS is also required to notify the public according to the provisions 
laid out in 40 CFR part 141 subpart Q.
     Report to the State a treatment technique violation no 
later than the end of the next business day after it learns of the 
violation. The PWS must also notify the public in accordance with 40 
CFR part 141 subpart Q.

[[Page 40948]]

     Report to the State monitoring violations within ten days 
after the system discovers the violation, and notify the public in 
accordance with 40 CFR part 141 subpart Q.
     Notify the State when each scheduled corrective action is 
completed for corrections not completed by the time of the submission 
of the assessment form.
    In addition, systems triggered into conducting an assessment are 
required to submit the completed assessment form within 30 days after 
determination that the coliform treatment technique trigger has been 
exceeded (see section III.A.3 of this preamble for additional 
discussion).
    ii. Recordkeeping. EPA is proposing to maintain the current TCR 
requirements regarding retention of sample results and records of 
decisions related to monitoring schedules found in 40 CFR 141.33, 
including provisions that address the new requirements of the proposed 
RTCR pertaining to reduced and increased monitoring, treatment 
technique, etc. In addition, systems are required to maintain on file 
for State review the assessment form or other available summary 
documentation of the sanitary defects and corrective actions taken. 
Systems are required to maintain these documents for a period not less 
than five years after completion of the assessment or corrective 
action.
    b. EPA's rationale. In the case of an E. coli-positive sample, the 
proposed RTCR maintains the current TCR requirement that systems must 
notify the State by the end of the day when they are notified of the E. 
coli-positive result or by the end of the next business day if the 
State office is already closed. The advisory committee believed that 
this requirement is important to maintain because of the potential for 
immediate public health risk associated with E. coli presence and the 
desire for States to consider quickly whether additional actions might 
be appropriate. The same rationale applies to E. coli MCL violations.
    Since there are new requirements for conducting assessments and 
corrective actions, and new conditions for obtaining increased or 
reduced monitoring provisions, the proposed rule includes reporting and 
recordkeeping requirements to facilitate tracking of Level 1 and Level 
2 triggers and compliance with treatment technique requirements. 
Systems are required to maintain these files no less than five years. 
Since systems have to maintain these files no shorter than the maximum 
period allowed between sanitary surveys (i.e., five years; see 40 CFR 
142.16(b)(3) and 40 CFR 142.16(o)(2)), States have the opportunity to 
look at and review these files during sanitary surveys and/or annual 
visits. The five year period is also consistent with the recordkeeping 
requirements for microbiological analyses under 40 CFR 141.33(a).
    The timeframe by which reporting and recordkeeping are required 
under the proposed rule is consistent with EPA's practice regarding 
reporting and recordkeeping requirements in other regulations under 
SDWA.
    c. Request for comment. EPA requests comment on whether the 
timeframe required for reporting and recordkeeping requirements are 
appropriate.
9. Analytical Methods
    a. AIP-related method issues. i. Evaluation of currently-approved 
methods. The AIP contains several recommendations by the advisory 
committee regarding the analytical methods approved under the proposed 
RTCR. The advisory committee noted that the methods currently approved 
under the current TCR have varying sensitivities and specificities, and 
recommended that `` * * * the Agency evaluate all currently approved 
coliform analytical methods to determine whether these methods continue 
to be appropriate for use in drinking water compliance monitoring'' 
(USEPA 2008c, AIP p. 7).
    In the twenty years since the current TCR was promulgated, many 
methods have been developed and approved for use. Most of the approved 
methods that are used to support the current TCR were evaluated under 
EPA's Alternate Test Procedure (ATP) process. Under this process, a 
proposed method is evaluated in comparison to a reference method. A 
favorable comparison serves as the basis for subsequent approval of the 
method for use in regulatory compliance monitoring.
    The ATP evaluations are designed based on the ATP Microbiology 
Protocol (USEPA 2004), an EPA guidance document that outlines how the 
evaluation study should be conducted. In the years the ATP program has 
been in place, the ATP guidance document has been revised several 
times. As a result of different protocols being used over time, the 
current set of approved methods have not all been evaluated under 
identical conditions.
    In addition to the concerns expressed by the advisory committee 
that the approved methods may not be equivalent to each other, EPA 
notes that there have been additional concerns with some of the methods 
currently approved. This includes allegations that some of the approved 
methods may have been modified since approval without EPA's knowledge. 
EPA is also aware of reports of varying performance of some enzyme-
based methods (Oldstadt et al. 2007; Fricker et al. 2003). Lastly, EPA 
is aware of at least one circumstance where the manufacturer of an 
approved method placed a ``product hold'' and recall on the medium 
after the product was reported to be experiencing reduced recovery of 
E. coli.
    For these reasons, EPA believes that additional information may be 
needed regarding the performance of the currently approved methods in 
order to justify their continued approval. Among the options, EPA is 
considering a complete, side-by-side method evaluation study, whereby 
all the methods are compared to each other under identical conditions, 
according to the same protocol.
    EPA is considering an approach under which vendors of all currently 
approved methods would have the option of voluntarily participating in 
an independent, third-party laboratory evaluation through EPA's 
Environmental Technology Verification (ETV) Program. The goal of the 
ETV Program is to provide independent, objective, and credible 
performance data for commercial-ready environmental technologies. More 
information on this program is available on EPA's Web site at 
www.epa.gov/etv/index.
    Under the ETV approach, EPA anticipates that participating vendors 
would generally fund the majority of the cost of their method 
evaluation. Based on the results of the ETV study, as documented in the 
verification report, EPA would judge the appropriateness of each 
analytical method and would determine which should continue to be 
approved for future monitoring. EPA would then make any changes to the 
analytical methods approved under the RTCR through later rulemaking.
    If a vendor chooses not to participate in the ETV study, EPA would 
allow the vendor to propose, for EPA's consideration, an equivalent 
alternative approach for method evaluation. EPA will determine whether 
the proposed approach will provide an independent, effective, and 
credible evaluation. EPA emphasizes that any alternative approach would 
need to be equivalent in scope and rigor to the ETV program. As with 
the ETV study, EPA would use the results from an alternative study to 
judge the appropriateness of each analytical method and would determine 
which methods warrant approval for future monitoring under this 
regulation.

[[Page 40949]]

    As described at EPA's April 2009 stakeholder meeting, the time 
required to plan and conduct a proper method evaluation, and to assess 
the results, is such that EPA does not expect to be able to complete 
this effort and to take action on the method evaluation in time for the 
results to be included in the final RTCR. Instead, and to the extent 
necessary, EPA would address the disapproval of any of the current 
methods, or restrictions on any methods, in independent regulatory 
actions.
    ii. Review of ATP protocol. The AIP further recommends that EPA 
``engage stakeholders in a technical dialogue in its review of the 
Alternative Test Procedure (ATP) microbial protocol for TC/E. coli 
methods for drinking water to determine if the criteria for acceptance 
of methods are consistent with the intent and objectives of the TCR * * 
*'' (USEPA 2008c, AIP p. 7). In response, EPA notes that the study plan 
developed for the re-evaluation of current methods (under an ETV or 
alternative approach) could serve as a starting point for discussions 
with stakeholders regarding the basis for evaluating new methods. The 
study plan could be used as a model for a revised ATP protocol; lessons 
learned from the re-evaluation could also inform EPA's future 
assessment of new methods.
    iii. Approval of ``24-hour'' methods. The AIP also recommends that 
EPA ``consider approving methods that allow the timely (e.g. on the 
order of 24 hours) analytical results for E. coli and TC and that 
provide relatively concurrent analyses, without significantly 
sacrificing accuracy, precision and specificity'' (USEPA 2008c, AIP p. 
7). EPA notes that many of the approved methods that may be used in 
compliance with the proposed rule can be completed in approximately 24 
hours. However, the methods that detect lactose fermentation include a 
confirmation step that involves transfer of a presumptively positive 
culture into a more inhibitory confirmation medium which serves to 
ensure the initial positive was correct. As a result of this 
confirmatory step, lactose fermentation methods can take up to 96 hours 
to obtain a result. The enzyme based methods do not require this 
confirmation step, and their results can be obtained in a 24 to 48 hour 
time period.
    EPA is aware of some concerns that methods with a 24 hour 
incubation time may not be able to detect as many coliform bacteria as 
methods with a 48 hour incubation period. Since many of the coliform 
bacteria found in a distribution system are injured or stressed due to 
disinfection practices, and since injured/stressed organisms may take 
longer to detect than 24 hours, this concern is of interest to EPA. As 
part of, or in addition to, the method evaluation previously described, 
EPA may therefore further investigate the impact of incubation time on 
the recovery of stressed/injured organisms in drinking water using 
approved media. At this time, EPA believes that it is premature to 
conclude that either enzyme-based or lactose-based methods are 
inherently preferable.
    As discussed during the advisory committee meetings, the analysis 
time of the analytical methods is just one aspect in the overall amount 
of time it takes before a PWS obtains sample results from the 
laboratory and subsequently collects repeat samples. Factors that can 
impact how quickly the PWS receives notification of a positive result 
include whether the PWS uses an in-house laboratory or must ship the 
sample to a distant contract laboratory, and whether the sample results 
are reported via an electronic means or via traditional mail. In 
addition, the turnaround time for repeat sampling can be affected by 
such factors as the laboratory daily hours of operation. The current 
TCR specifies that repeat samples be collected within 24 hours, but 
States currently have the flexibility to extend this timeline. The 
current TCR does not contain provisions for how quickly the laboratory 
must notify the PWS when a positive result is obtained. This proposal 
does not change these provisions.
    iv. Elimination of fecal coliforms under the proposed RTCR. The AIP 
also contains a recommendation that EPA remove all provisions related 
to fecal coliforms under the proposed RTCR. Consistent with this 
recommendation, and for the following reasons, EPA is proposing to 
eliminate all fecal coliform provisions in the RTCR.
    First, the fecal coliform group can contain bacteria not associated 
with fecal contamination. E. coli is the most prominent member of the 
fecal coliform group. However, other coliform bacteria, such as 
thermotolerant strains of Klebsiella spp., have been shown to occur in 
the fecal coliform group (Warren et al. 1978). These non-E. coli 
bacteria are often found in environmental sources (for example, soil, 
vegetation, water) and, therefore, are not exclusively associated with 
feces. Due to the presence of these non-fecal bacteria, the fecal 
coliform group may not always provide the public water system with 
meaningful data regarding the vulnerability of their distribution 
system to fecal contamination.
    Secondly, when the current TCR was developed, there were few E. 
coli methods available. Many public water systems were familiar with 
and preferred to use the fecal coliform methods. However, since the 
current TCR was promulgated, many E. coli methods have been developed 
and approved for use. EPA believes that most systems nationwide 
currently test for E. coli, while few test for fecal coliform bacteria. 
Since the methods used to test for E. coli have approximately the same 
cost as those used to test for fecal coliform bacteria, this proposed 
change is not expected to create an additional burden on PWSs.
    EPA is proposing to eliminate all analytical method provisions for 
fecal coliforms that are included in the current TCR. EPA proposes 
instead to allow testing only for E. coli following a total coliform-
positive sample. This change will provide the water system with more 
meaningful information regarding potential fecal contamination of the 
distribution system.
    The current TCR specifies a number of analytical methods that can 
be used for compliance sample analysis (in 40 CFR 141.21(f)). Since 
fecal coliform bacteria are not regulated contaminants under this 
proposed rule, the analytical methods for fecal coliforms are no longer 
applicable and are removed from the list of analytical methods. All 
other methods used for compliance with the current TCR are maintained 
for compliance sample analysis under the proposed RTCR.
    v. Request for comment on AIP-related method issues. EPA is 
requesting comment on the following RTCR analytical method issues 
related to recommendations from the TCRDSAC in its AIP:
     The use of an ETV approach for a reevaluation of 
analytical methods.
     Whether the RTCR should include provisions to ensure a 
more expedited results notification process. The RTCR could, for 
example, include language requiring that PWSs arrange to be notified of 
a positive result by their laboratory within 24 hours.
     Whether the RTCR should require repeat samples be taken 
within 24 hours of a total coliform-positive with no (or limited) 
exceptions.
    b. Other method issues. In addition to addressing the 
recommendations of the advisory committee, EPA is proposing some minor 
technical changes related to analytical methods. Many of these changes 
document practices that are already followed by PWSs and laboratories, 
and are consistent with the

[[Page 40950]]

Manual for the Certification of Laboratories Analyzing Drinking Water 
(referred to as the ``Laboratory Certification Manual'') (USEPA 2005), 
an EPA document that outlines method requirements and good laboratory 
practices for certified laboratories conducting drinking water 
compliance sample analyses.
    Some of these changes were brought to the attention of EPA by EPA 
Regions and States involved in the implementation of the drinking water 
certification program. Other minor changes have been proposed to make 
the analytical methods section of this regulation easier to understand 
and implement. Each proposed change is described as follows with a 
discussion of the rationale for the change.
    i. Holding time. The proposed RTCR continues to provide a 30-hour 
holding time limit for the samples collected in compliance with this 
regulation (40 CFR 141.21(f)(3)). However, EPA is proposing to change 
the definition for holding time from ``the time from sample collection 
to initiation of analysis may not exceed 30 hours'' to ``the time from 
sample collection to initiation of test medium incubation may not 
exceed 30 hours.''
    ii. Dechlorinating agent for sample preservation of chlorinated 
water supplies. The proposed RTCR establishes the following provision: 
``If chlorinated water is to be analyzed, sufficient sodium thiosulfate 
(Na2S2O3) must be added to the sample 
bottle before sterilization to neutralize any residual chlorine in the 
water sample.'' Dechlorination procedures are addressed in section 
9060A.2 of Standard Methods for the Examination of Water and Wastewater 
(20th and 21st editions) (Clesceri et al. 1998; Eaton et al. 2005).
    iii. Filtration funnels. EPA is proposing to add the following 
footnote to the analytical methods table (Sec.  141.852) under the 
revised rule:

    All filtration series must begin with membrane filtration 
equipment that has been sterilized by autoclaving. Exposure of 
membrane filtration equipment to UV light is not adequate to ensure 
sterilization. Subsequent to the initial autoclaving, exposure of 
the filtration equipment to UV light may be used to sanitize the 
funnels between filtrations within a filtration series.

    iv. Analytical methods table changes. EPA is proposing the 
following changes to the analytical methods table:
     The table is organized by methodology (e.g., lactose-
fermentation methods vs. enzyme-substrate methods).
     E. coli methods are included in the table.
     18th and 19th editions of Standard Methods for the 
Examination of Water and Wastewater are no longer approved and have 
been removed.
     The references to Standard Methods 9221A and 9222A are 
removed.
     The reference to Standard Methods 9221B is changed to 
9221B.1, B.2.
     The reference to Standard Methods 9221D is changed to 
9221D.1, D.2.
     The table proposes to allow Standard Methods 9221D in the 
multiple tube format as described in Standard Methods 9221B.
     The citation for MI agar is changed to EPA Method 1604 for 
clarity and consistency.
     The table clarifies that Standard Methods 9221 F.1 and 
9222 G.1a (1), (2) may be used for E. coli analysis.
     The table clarifies the correct formulation for EC-MUG 
broth, when used in conjunction with Standard Methods 9222G.1a(2), 
through the addition of the following footnote:

    The following changes must be made to the EC broth with MUG (EC-
MUG) formulation: Potassium dihydrogen phosphate, 
KH2PO4 must be 1.5g and 4-methylumbelliferyl-
Beta-D-glucuronide must be 0.05 g.

     The table reflects the approval of a modified Colitag 
method for the simultaneous detection of E. coli and other total 
coliforms.
    v. EPA's rationale for proposed changes related to other method 
issues. (a). Holding time.
    The current rule states ``The time from sample collection to 
initiation of analysis may not exceed 30 hours'' (40 CFR 141.21 
(f)(3)). Since promulgation of the current TCR, some States and EPA 
Regions have commented that ``initiation of analysis'' may be 
interpreted several different ways, which can lead to the sample being 
held longer than the 30 hours intended by the rule. The proposed 
language more clearly defines the amount of time that the sample may be 
held and is consistent with section 6.4.1 of the Manual for the 
Certification of Laboratories Analyzing Drinking Water which states: 
``For the analysis of total coliform in drinking water, the time 
between sample collection and the placement of sample in the incubator 
must not exceed 30 hours.''
    EPA believes that changing the definition of holding time from 
``the time from sample collection to initiation of analysis'' to ``the 
time from sample collection to initiation of test medium incubation'' 
may slightly decrease the amount of time a PWS has to get the sample to 
a laboratory. EPA does not believe that this change will significantly 
reduce the amount of time a water system has to get a sample to the 
laboratory, as most of the methods approved under this rule require 30 
minutes or less to process and prepare the sample for the incubation 
step. Thus, the initial analytical steps should not constitute a large 
portion of the holding time as a whole. EPA recommends that PWSs that 
have difficulty meeting the holding time notify the laboratory that the 
samples are in transit and need to be given priority. The laboratory 
could begin analysis immediately upon sample arrival so that the 
samples could be placed in the incubator in time to meet the 30 hour 
holding time. EPA notes that a laboratory may have to make specific 
accommodations in their processes in order to properly analyze a sample 
received close to the end of the holding time. EPA believes that this 
is feasible with proper planning.
    (b). Dechlorinating agent for sample preservation of chlorinated 
water supplies. Under this proposal, EPA would require that chlorinated 
water samples be collected in bottles that contain the dechlorinating 
agent sodium thiosulfate. This is consistent with section 3.15.4 of the 
Laboratory Certification Manual, which states ``If chlorinated water is 
to be analyzed, sufficient sodium thiosulfate 
(Na2S2O3) must be added to the sample 
bottle before sterilization to neutralize any residual chlorine in the 
water sample.'' Neutralization ceases the bactericidal action of the 
chlorine during sample transit, thus allowing a more accurate 
assessment of what the true microbial content of the water sample was 
at the time of sample collection. Implementation of this new 
requirement should be straightforward since PWSs need only ask the 
laboratory for pre-treated sample containers. EPA does not believe this 
provision will cause an increase in cost to PWSs, as the cost of the 
bottles with the sodium thiosulfate is essentially the same as the cost 
of the bottles without the sodium thiosulfate.
    (c). Filtration funnels. Under this proposal, EPA is requiring that 
membrane filtration equipment be autoclaved before beginning a 
filtration series. This requirement is consistent with section 4.1.3 of 
the Laboratory Certification Manual, which states: ``Membrane filter 
equipment must be autoclaved before the beginning of a filtration 
series.''
    Under the current TCR, not all of the approved membrane filtration 
methods require that a filtration series begin with membrane filtration 
units that have been sterilized by autoclave. Some of the approved 
methods allow the laboratory to use ultraviolet (UV)

[[Page 40951]]

radiation exposure in lieu of autoclaving to sterilize filtration units 
between filtration series. EPA does not believe that ultraviolet 
radiation is sufficient to properly sterilize the membrane filtration 
equipment. Additionally, EPA believes that when ultraviolet radiation 
is used, not all areas of the membrane filtration equipment are 
exposed, and therefore microorganisms may persist and contaminate other 
water samples and the laboratory. For these reasons, EPA is proposing 
to include a footnote to the analytical methods table in order to 
ensure proper sterilization.
    EPA does, however, believe that ultraviolet light can be used to 
sanitize the filtration equipment between filtrations within a 
filtration series, as stated in section 4.1.4 of the Laboratory 
Certification Manual: ``Ultraviolet light (254 nm) may be used to 
sanitize equipment (after initial autoclaving for sterilization), if 
all supplies are pre-sterilized. Ultraviolet light may be used to 
reduce bacterial carry-over between samples during a filtration 
series.''
    (d). Analytical methods table. In this proposal, EPA is identifying 
a number of changes to the analytical methods table for clarity and 
accuracy.
    In the current TCR, the methods are listed by date approved and the 
E. coli methods are listed in a text format. In this proposal, the 
analytical methods table is organized by methodology (e.g., lactose-
fermentation methods vs. enzyme-substrate methods), and the E. coli 
methods are included in the table.
    Standard Methods for the Examination of Water and Wastewater is a 
reference document designed to represent ``the best current practice of 
American water analysts.'' Periodically, new editions are published in 
order to incorporate improvements in the methods contained within this 
manual. Thus, new editions of this publication contain more current and 
improved versions of the methods. Under the current TCR, four editions 
of this publication are approved, resulting in different, oftentimes 
outdated, versions of the same method being approved. Having multiple 
editions of this manual approved under this regulation also creates a 
burden for the laboratory certification officers who must understand 
the differences between the versions of the method for which the 
laboratory may be seeking certification. For these reasons, EPA is 
proposing to remove the 18th and 19th editions of Standard Methods for 
the Examination of Water and Wastewater for use in compliance sample 
analysis under the RTCR. EPA expects that the burden associated with 
this change will be minimal as most laboratories have already procured 
the newer editions or have arranged for access to the online 
publication.
    In this proposed regulation, the reference to Standard Methods 
9221A and 9222A are removed. These sections of the methods contain only 
introductory information, not any actual methodology. They do not 
represent methods approved for use under this regulation.
    The references to Standard Methods 9221B and 9221D are modified in 
this proposed regulation. In the current TCR, the methods are 
referenced as 9221B and 9221D with footnote 5 denoting that the 
``completed phase'' called for in the methods is not required. By more 
specifically citing Standard Methods 9221 B.1, B.2, and 9221 D.1, D.2 
(which contain the applicable, required steps of these methods) EPA is 
able to eliminate the original footnote and improve clarity.
    EPA is proposing to allow Standard Methods 9221D (Presence-Absence 
broth) to be used in a multiple tube format. This method has 
traditionally been used in a single bottle, allowing only the 
qualitative detection of total coliforms. However, there are published 
reports showing this method can be used in a multiple tube format for 
the quantitative detection of total coliforms (Rice et al. 1987; Rice 
et al. 1993). This medium would be used in the same manner that Lauryl 
Tryptose Broth (LTB) is described as being used in Standard Methods 
9221B. Allowing the use of this method in a multiple tube format would 
allow PWSs that use this method to quantitate any total coliforms that 
may occur in the water sample.
    EPA is proposing to change the citation for MI Agar. Under the 
current TCR, this method is cited as Standard Methods 9222, with a 
footnote citing the Applied and Environmental Microbiology article 
where the method was initially described. In this proposal, the method 
is now cited as EPA Method 1604, consistent with section 5.4.2.1.3 of 
the Laboratory Certification Manual. EPA Method 1604 is identical to 
the citation in the TCR and does not require the use of the original 
footnote. This change is also consistent with the citation of this 
method as listed in the Ground Water Rule (see 40 CFR 141.402).
    The current TCR describes the use of ``EC medium supplemented with 
50 [mu]g/mL of 4-methylumbelliferyl-Beta-D-glucuronide (MUG)'' (see 40 
CFR 141.21(f)(6)(i)). This proposal clarifies that this medium, 
included in both Standard Methods 9221F and Standard Methods 
9222G.1a(2), is approved for use under this regulation. This is 
consistent with the Laboratory Certification Manual, particularly 
section 5.1.8, which describes both of these methods as approved for 
use in the detection of E. coli under this regulation.
    Lastly, EPA is clarifying the formulation for EC broth with MUG 
(EC-MUG) given in Standard Methods 9222G.1a(2) to correct an error in 
the publication. The Standard Methods 9222G.1a(2) formulation calls for 
0.1 g of 4-methylumbelliferyl-Beta-D-glucuronide, and 1.4g 
KH2PO4. This formulation differs from that given 
in Standard Methods 9221F.1, which calls for 0.05 g and 1.5 g, 
respectively. EPA believes that the correct formulation is given in 
Standard Methods 9221F and has confirmed this with Standard Methods 
committee members (Rice 2009). Accordingly, EPA has added a footnote to 
the 9222G.1a(2) stating the proper formulation.
    EPA anticipates that these changes to the analytical methods table 
will not cause any additional burden to the PWSs.
    vi. Request for comment regarding holding temperature. The current 
TCR states the following regarding sample shipment: ``Systems are 
encouraged but not required to hold samples below 10 deg. C during 
transit.'' Other national primary drinking water regulations requiring 
microbial sampling require that the samples be shipped in cold 
conditions, and require the sample be maintained at a temperature of 10 
degrees Celsius (C) or less. Maintaining the sample temperature below 
10 degrees C serves to preserve the bacterial population by minimizing 
both bacterial cell death and cell multiplication, thus allowing for a 
more accurate representation of the microbial population in the sample 
at the time of sample collection. Also, Standard Methods for 
Examination of Water and Wastewater, 21st edition (Eaton et al. 2005) 
recommends that samples be shipped at less than 8 degrees C but not 
frozen.
    In the years since the promulgation of the current TCR, EPA has 
heard concern that at times, samples collected under the TCR may reach 
high temperatures during transit to the laboratory due to the lack of a 
requirement to ship samples on ice. High temperatures that may be 
reached during transit could have a deleterious or prolific effect on 
the bacterial cells present in the samples such that the samples may no 
longer represent the microbial content of the water at the time of 
sample collection.
    EPA recognizes that requiring the samples under the proposed RTCR 
to be held at 10 degrees C or less, but above

[[Page 40952]]

freezing, would result in an increased cost to the water systems (for 
shipping, supplies, etc.), but believes the extra burden may be 
warranted. EPA is seeking public comment on whether this passage should 
remain as is in the current TCR or whether the RTCR should require that 
the samples collected for compliance with this regulation be shipped in 
cold conditions, i.e., requiring a temperature of 10 degrees C or less, 
but above freezing to be maintained for better sample preservation. EPA 
also welcomes comments and supporting data on what the acceptable 
temperature range should be when samples are in transit.

B. Proposed Compliance Date

    Consistent with SDWA section 1412(b)(10), EPA proposes that the 
compliance date of the final RTCR be three years from the date on which 
the regulation is promulgated (i.e., the publication date of the final 
rule in the Federal Register). PWSs must comply with the requirements 
of the rule by the compliance date.
    EPA believes that capital improvements generally are not necessary 
to ensure compliance with the proposed RTCR. However, a State may allow 
individual systems up to two additional years to comply with the RTCR 
if the State determines that additional time is necessary for capital 
improvements, in accordance with SDWA section 1412(b)(10).
    EPA requests comment on the proposed compliance date of the 
proposed RTCR.

C. Links to Other Drinking Water Rule Requirements

    The proposed RTCR recognizes that existing NPDWRs contain linkages 
among monitoring requirements in different rules. The current residual 
disinfectant monitoring must be conducted at the same time and location 
at which TCR samples are taken, as provided for in the Surface Water 
Treatment Rule (SWTR) (USEPA 1989b, 54 FR 27486, June 29, 1989) and the 
Stage 1 Disinfectants and Disinfection Byproducts Rule (Stage 1 DBPR) 
(USEPA 1998a, 63 FR 69389, December 16, 1998). Under the GWR, TCR 
distribution system monitoring results determine whether a system is 
required to conduct source water monitoring. Under the SWTR, high 
measurements of turbidity in an unfiltered subpart H system of this 
part trigger additional total coliform samples. Sanitary survey 
provisions exist in surface water and ground water drinking water 
regulations. The proposed RTCR does not change the existing sanitary 
survey requirements except to add the special monitoring evaluation 
that States must conduct at systems serving 4,100 or fewer people. 
These evaluations do not increase the burden to conduct sanitary 
surveys because of the relatively simple nature of these systems and 
their monitoring requirements.
1. SWTR, Stage 1 and Stage 2 DBPRs, ADWR
    After considering the possible linkages among the proposed RTCR and 
the SWTR, Stage 1 DBPR, Stage 2 DBPR (USEPA 2006e, 71 FR 388, January 
4, 2006), and Airline Drinking Water Rule (ADWR) (USEPA 2009), EPA has 
concluded that the only necessary revision is to update the reference 
to the current TCR at 40 CFR 141.21, which is superseded by 40 CFR part 
141 subpart Y beginning three years following publication of the final 
rule. EPA is also proposing several revisions to other NPDWRs, 
discussed below, that are not necessary but would facilitate 
implementation of all applicable NPDWRs.
2. GWR
    As with the other drinking water rules mentioned above, EPA is 
proposing to update the references in the GWR to the current TCR at 40 
CFR 141.21, which will be superseded by 40 CFR part 141 subpart Y.
3. Sanitary Surveys
    Sanitary survey requirements are not included in the proposed RTCR. 
Under the current TCR, community water systems and non-community water 
systems that serve 4,100 or fewer people are required to conduct 
periodic sanitary surveys. Since the promulgation of the TCR in 1989, 
new sanitary survey requirements for surface water systems and ground 
water systems have been established for all system sizes and types 
under the Interim Enhanced Surface Water Treatment Rule (IESWTR) (USEPA 
1998b, 63 FR 69477, December 16, 1998) (40 CFR 142.16(b)(3)), and the 
Ground Water Rule (GWR) (40 CFR 142.16(o)(2)(i)). Public water systems 
began implementing the IESWTR sanitary survey requirements in 2001. 
Therefore, for surface water systems, the current TCR sanitary survey 
requirements have phased out since that time. Implementation of the GWR 
sanitary survey requirements began in December 2009 for ground water 
systems. Therefore, for ground water systems, the GWR sanitary survey 
requirements will be in effect by the time the RTCR is finalized.

D. Best Available Technology (BAT)

1. Provisions

    The proposed RTCR would maintain the provisions set forth in 40 CFR 
141.63(d) (proposed to be in Sec.  141.63(e)), regarding the best 
technology, treatment techniques, or other means available for 
achieving compliance with the MCL of either total coliforms or E. coli. 
EPA is proposing the following modifications:
     40 CFR 141.63(d)(1) (proposed Sec.  141.63(e)(1)) would be 
modified by replacing ``coliforms'' with ``fecal contaminants.''
     40 CFR 141.63(d)(3) (proposed Sec.  141.63(e)(3)) would be 
modified by including ``cross connection control'' in the list of 
proper maintenance practices for the distribution system.
     40 CFR 141.63(d)(4) (proposed Sec.  141.63(e)(4)) would be 
modified by including the subparts P, T, and W that describe filtration 
and/or disinfection of surface water, and subpart S for disinfection of 
ground water.
2. EPA's Rationale
    a. Change ``coliform'' to ``fecal contaminants.'' This change 
reflects the approach of the proposed RTCR that the presence of total 
coliforms does not necessarily have a direct public health implication. 
Instead, total coliform is used as an indicator of a potential pathway 
of contamination within a treatment technique requirement. For 
additional discussion on this topic, see section III.A.2 of this 
preamble.
    b. Inclusion of cross connection control. EPA believes that adding 
cross connection control to the list of proper maintenance practices 
for distribution systems is appropriate because of the significant 
contribution of cross connections and backflow to waterborne disease 
outbreaks. From 1981 to 1998, the CDC documented 9, 734 detected and 
reported illnesses from 57 waterborne outbreaks related to cross 
connections (NRC 2006). From 1970 to 2001, approximately 12,000 
illnesses resulted from 459 incidents of waterborne outbreaks from 
backflow events (NRC 2006).
    c. Addition of other relevant subparts of 141. This change adds 
references to subparts that contain provisions for the other drinking 
water rules promulgated since 1989 when the TCR was promulgated (in 
particular, subpart P for the IESWTR, subpart S for the GWR, subpart T 
for the Long Term Enhanced Surface Water Treatment Rule (USEPA 2002, 67 
FR 1812, January 14, 2002, and subpart W for the Long Term 2 Enhanced 
Surface Water Treatment Rule (USEPA 2006d, 71 FR 654, January 5,

[[Page 40953]]

2006)). These drinking water rules contain updated filtration and 
disinfection standards that were not part of the current TCR when it 
was promulgated in 1989.
3. Request for Comment
    EPA requests comment on the modifications to the existing BATs and 
whether there is a need to add or otherwise update the list of BATs.

E. Variances and Exemptions

1. Provisions
    EPA is proposing to not allow variances or exemptions to the E. 
coli MCL. EPA is also proposing to eliminate the variance provisions in 
40 CFR 141.4(b) that allow systems to demonstrate to the State that the 
violation of the monthly/non-acute total coliform MCL is due to biofilm 
and not fecal or pathogenic contamination. This change will also result 
in a parallel change in 40 CFR 142.63(b).
2. EPA's Rationale
    Under the proposed RTCR, E. coli is used as an indicator of fecal 
contamination that may contain waterborne pathogens. To the extent a 
variance or exemption would permit the continued presence of E. coli, 
the potential for pathogens to be present also would remain. EPA 
believes that water which exceeds the MCL for E. coli poses an 
unreasonable risk to public health. Therefore, EPA is not allowing any 
variances or exemptions to the E. coli MCL. This provision is 
consistent with the existing requirement, since the provision that 
allows variances applies only to the monthly/non-acute total coliform 
MCL violation and not to the acute violation associated with the 
presence of E. coli.
    Under the current TCR, EPA allows variances to the MCL for total 
coliforms when a system has demonstrated to the State that the 
violation of the total coliform MCL is due to a persistent growth of 
total coliforms in the distribution system (i.e., biofilm) rather than 
fecal or pathogenic contamination, a treatment lapse or deficiency, or 
a problem in the operation or maintenance of the distribution system.
    EPA is proposing to eliminate the variance in 40 CFR 141.4(b) 
because under the proposed RTCR, there would no longer be an MCL for 
total coliforms (see section III.A.2 of this preamble). The current TCR 
MCL for total coliforms was based on the presence or absence of total 
coliforms in a sample (see 40 CFR 141.63 for details). In the proposed 
RTCR, the presence of total coliforms at a certain level requires the 
system to comply with the coliform treatment technique requirements 
(see section III.A.5 of this preamble). The assessment and corrective 
action requirements under this proposed rule include the possibility of 
recognizing that the total coliform presence is associated with 
biofilm. EPA plans to include this information in a new assessment and 
corrective action guidance manual related to the RTCR.
3. Request for Comment
    EPA requests comment on its proposal to allow no variance or 
exemption to the E. coli MCL and to eliminate the variance provisions 
associated with the monthly/non-acute total coliform MCL.

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

1. Consistency Between the Proposed RTCR and the GWR
    EPA requests comment on the need for general consistency between 
the proposed RTCR and the GWR. Please provide specific examples. For 
example, under the current TCR, States are required to keep records of 
their decision to either waive or extend the 24-hour limit for 
collecting samples (that is, for repeat samples following a total 
coliform-positive sample, or for follow-up samples after high levels of 
turbidity) (see 40 CFR 142.14(a)(5)(i)(A) and 142.14(a)(5)(ii)(D)). The 
proposed RTCR also requires States to keep records of decisions to 
either waive or extend the 24-hour limit for repeat samples following a 
total coliform-positive sample, for samples following invalidation, or 
for follow-up samples after high levels of turbidity (see Sec. Sec.  
142.14(a)(10)(i)(A) and 142.14(a)(10)(ii)(D) of the proposed RTCR). 
Under the GWR, there are no recordkeeping requirements for the decision 
to waive or extend the 24-hour limit. Instead, the GWR includes special 
primacy requirements to describe criteria the State will use to extend 
the 24-hour limit (see 40 CFR 142.16(o)(3)(i)). EPA requests comment on 
whether it is appropriate to have States describe their criteria for 
waiving or extending the 24-hour limit as a primacy condition, or 
instead have States keep records of decisions to waive and/or extend 
the 24-hour limit.
2. Storage Tank Inspection and Cleaning
    EPA requests comment on the value and cost of periodic storage tank 
inspection and cleaning. There are instances of storage tanks being the 
source of waterborne disease outbreaks at PWSs. In December 1993, a 
Salmonella typhimurium outbreak in Gideon, Missouri resulted in over 
600 people affected by diarrhea, 31 cases of laboratory-confirmed 
salmonellosis and seven deaths of nursing home residents who had 
exhibited diarrheal illness (four deaths were confirmed by culture). 
The larger of the two storage tanks had a breach in the roof hatch that 
allowed pigeon droppings to be carried into the tank and likely 
accumulated in the several inches of sediment. This contaminated 
sediment, more than likely, was pulled into the distribution system by 
a flushing program that drained the tank (Clark et al. 1996). 
Salmonella typhimurium was isolated from the sediment of one of the 
towers, and tap water tested positive for fecal coliforms (CDC 1996).
    In March 2008, Alamosa, Colorado (with a population of about 9,000 
people) experienced a waterborne disease outbreak associated with 
Salmonella. The report released by the Colorado Department of Public 
Health and Environment (Falco and Williams 2009) indicated that the 
outbreak resulted in 442 reported cases of illnesses, 122 of which were 
laboratory confirmed, and one fatality. The State epidemiologist 
estimated that a total of 1,300 people may have been ill. Two storage 
tanks in Alamosa had several inches of sediment and breaches; one tank 
had breaches large enough for birds and animals to enter. Some of the 
key factors that contributed to these two outbreaks include significant 
levels of sediment (several inches to feet) and the presence of 
breaches of the integrity of the storage tank.
    Sediment accumulation occurs within storage facilities due to 
quiescent conditions which promote particle setting. Over time sediment 
continues to accumulate in a tank, even if the finished water is 
consistently treated to below 0.1 nephelometric turbidity unit (NTU). 
For surface water systems, it is not uncommon to have \1/4\ to \1/2\ 
inch or more of sediment accumulate after two to three years (Kirmeyer 
et al. 1999). While there are no turbidity regulations for ground water 
systems (except for ground water under the direct influence of surface 
water (GWUDI)), the levels of turbidity can be significant in the water 
pumped from an aquifer. Sand particles, if allowed to accumulate, 
provide pore spaces that house diverse populations of biota (which may 
include pathogenic microorganisms) (Kirmeyer et al. 1999; van der Kooij 
2003). Periodic high flows in the storage tank may scour, stir up, and 
suspend the sediment (along with entrapped bacteria and pathogens) and 
carry it into the distribution system, with greater accumulation of 
sediment

[[Page 40954]]

being a more significant concern. Other water quality problems 
associated with sediment accumulation include increased disinfectant 
demand and disinfection byproduct formation.
    The storage tank's vulnerability to contamination increases when 
breaches of the storage tank allow insects, animals, and birds and 
their associated diseases to enter. Contamination from bird and other 
animal excrement can potentially transmit disease-causing organisms to 
the finished water. Waterfowl, for example, are known carriers of many 
different waterborne pathogens including Vibrio cholerae (Ogg et al. 
1989).
    Based on the potential public health implications associated with 
poorly maintained storage tanks (e.g., as indicated by significant 
sediment accumulation and breaches), EPA is interested in receiving 
comments and supporting information regarding the state and condition 
of tanks that have been cleaned and inspected, costs of storage tank 
inspection and cleaning, and how public health can be better protected. 
EPA requests information on whether there are States that recommend or 
require periodic inspection and cleaning of storage tanks. If so, what 
are the requirements, the frequency of inspection and cleaning, and how 
successful are they? Are inspections and cleaning done by individual 
PWSs or by contractors?
3. States Under EPA Direct Implementation
    EPA does not have the authorities provided to other primacy 
agencies under 40 CFR part 142 to use in implementing rules in direct 
implementation entities (e.g., Tribal systems and Wyoming). To provide 
EPA the flexibility of other primacy agencies to modify monitoring 
requirements as necessary to protect public health (e.g., to require 
more stringent monitoring or to develop criteria such as those that 
primacy States develop under the special primacy conditions requirement 
in 40 CFR 142.16) and facilitate implementation of this rule. EPA is 
requesting comment on whether the Agency should have the same 
authorities specified in subpart Y, as States have in 40 CFR 142.16, 
for PWSs for which the Agency has direct implementation 
responsibilities. EPA is requesting comment on whether this authority 
should be added to subpart Y specifically.

G. Limitations to the Public Comment on the Proposed RTCR

    The proposed revisions to other drinking water regulations (SWTR, 
Stage 1 DBPR, Stage 2 DBPR, and ADWR) are made solely to update the 
reference to the current TCR at 40 CFR 141.21, which will be superseded 
by 40 CFR part 141 subpart Y beginning three years following 
publication of the final rule. This proposed rule would not change any 
substantive requirements of those rules and EPA is not soliciting 
public comments on those rules other than their proposed revised 
references to the current TCR or any other references to the current 
TCR that EPA may need to revise.

IV. State Implementation

    The proposed RTCR provides States with flexibility to implement the 
requirements of the rule in a manner that maximizes the efficiency of 
the rule for the States and water systems while increasing the 
effectiveness of the rule to protect public health. While the proposed 
rule provides some reduction in monitoring relative to the current TCR, 
overall, the proposed rule is more stringent and better protects public 
health. As a result, States must adopt these revisions, when final, or 
adopt or maintain more stringent requirements, in order to maintain 
primacy. This section describes the regulations and other procedures 
and policies States must adopt in order to obtain primacy to implement 
the RTCR, if finalized as proposed today.
    SDWA section 1413 establishes requirements that States or eligible 
Indian Tribes must meet to assume and maintain primary enforcement 
responsibility (primacy) for its PWSs. These requirements include:
     Adopting drinking water regulations that are no less 
stringent than Federal drinking water regulations;
     Adopting and implementing adequate procedures for 
enforcement;
     Keeping records and making reports available on activities 
that EPA requires by regulation;
     Issuing variances and exemptions (if allowed by the 
State), under conditions no less stringent than allowed under SDWA; and
     Adopting and being capable of implementing an adequate 
plan for the provisions of safe drinking water under emergency 
situations.
    States may adopt more stringent requirements (e.g., requiring all 
systems to conduct routine monthly monitoring). Many States have used 
this authority in the past to improve public health protection and/or 
simplify implementation.
    Section 1413(a)(1) of SDWA provides two years (plus up to two more 
years if the Administrator approves) after promulgation of the final 
RTCR for the State to adopt corresponding drinking water regulations in 
order to obtain primacy for the final RTCR. To implement the final 
RTCR, States would be required to adopt or maintain requirements that 
are at least as stringent as the following revisions to 41 CFR part 
141:
     Section 141.4--Variances and exemptions (if allowed by the 
State).
     Section 141.21--Coliform sampling.
     Section 141.52--Maximum contaminant level goals for 
microbiological contaminants.
     Section 141.63--Maximum contaminant levels (MCLs) for 
microbiological contaminants.
     Section 141.74--Analytical and monitoring requirements.
     Section 141.132--Monitoring requirements.
     Subpart 141.153--Content of the reports.
     Subpart 141.202--Tier 1 Public Notice--Form, manner, and 
frequency of notice.
     Subpart 141.203--Tier 2 Public Notice--Form, manner, and 
frequency of notice.
     Subpart 141.204--Tier 3 Public Notice--Form, manner, and 
frequency of notice.
     Subpart O--Consumer Confidence Reports, Appendix A, 
Regulated Contaminants.
     Subpart Q--Public Notification of Drinking Water 
Violations, Appendix A, NPDWR Violations and Other Situations.
     Subpart Q--Public Notification of Drinking Water 
Violations, Appendix B, NPDWR Violations and Other Situations.
     Subpart Y--Revised Total Coliform Rule.
    EPA's regulation at 40 CFR part 142 sets out the specific program 
implementation requirements for States to obtain primacy for the public 
water supply supervision program as authorized under SDWA section 1413. 
In addition to adopting basic primacy requirements specified in 40 CFR 
part 142, States may be required to adopt special primacy provisions 
pertaining to specific regulations where implementation of the rule 
involves activities beyond general primacy provisions. States must 
include these regulation-specific provisions in their application for 
approval of their program revision. States must continue to meet all 
other conditions of primacy for all other rules in 40 CFR part 142. 
Primacy requirements for the proposed RTCR are described below.
    The advisory committee recognized that this rule will require more 
tracking to ensure effective implementation.

[[Page 40955]]

Therefore, EPA plans to release an upgrade to SDWIS/State and SDWIS/FED 
(the State and Federal versions of the Safe Drinking Water Information 
System, respectively) within 18 months of final rule promulgation to 
accommodate monitoring data, tracking, compliance determinations and 
reporting of all rule related requirements, as appropriate.

A. State Special Primacy Requirements

    To ensure that a State program includes all the elements necessary 
for an effective and enforceable program under the proposed RTCR, a 
State primacy application must include a description of how the State 
will perform the following:
     Sample Siting Plans--States must describe the frequency 
and process used to review and revise sample siting plans in accordance 
with 40 CFR 141, subpart Y to determine adequacy.
     Reduced Monitoring Criteria--The primacy application must 
indicate whether the State will adopt the reduced monitoring provisions 
of subpart Y. If the State adopts the reduced monitoring provisions, it 
must describe the specific types or categories of water systems that 
will be covered by reduced monitoring and whether the State will use 
all or a reduced set of the optional criteria. For each of the reduced 
monitoring criteria, both mandatory and optional, the State must 
describe how the criteria will be evaluated to determine when systems 
qualify.
     Assessments and Corrective Actions--States must describe 
their process to implement the new assessment and corrective action 
phase of the rule. The description must include examples of sanitary 
defects, examples of assessment forms or formats, and methods that 
systems may use to consult with the State on appropriate corrective 
actions.
     Invalidation of routine and repeat samples collected under 
subpart Y--States must describe their criteria and process to 
invalidate total coliform-positive and E. coli-positive samples under 
subpart Y. This includes criteria to determine if a sample was 
improperly processed by the laboratory, reflects a domestic or other 
non-distribution system plumbing problem or reflects circumstances or 
condition that does not reflect water quality in the distribution 
system.
     Approval of individuals allowed to conduct subpart Y Level 
2 assessments--States must describe their criteria and process for 
approval of individuals allowed to conduct subpart Y Level 2 
assessments.
     Special monitoring evaluation--States must describe how 
they will perform special monitoring evaluations during sanitary 
surveys for ground water systems serving 1,000 or fewer people to 
determine whether systems are on an appropriate monitoring schedule.
     Seasonal systems--States must describe how they will 
identify seasonal systems, how they will determine when systems on less 
than monthly monitoring must monitor, and what will be the seasonal 
system start-up provisions.
     Additional criteria for reduced monitoring--States must 
describe how they will require systems on reduced monitoring to 
demonstrate:
    --Continuous disinfection entering the distribution system and a 
residual in the distribution system;
    --Cross connection control;
    --Other enhancements to water system barriers; and
    --Procedures for seasonal systems to start up operations at the 
beginning of each season.

B. State Recordkeeping Requirements

    The current regulations in 40 CFR 142.14 require States with 
primacy to keep records, including: Analytical results to determine 
compliance with MCLs, MRDLs, and treatment technique requirements; PWS 
inventories; State approvals; enforcement actions; and the issuance of 
variances and exemptions. The proposed RTCR requires States to keep 
additional records, including all supporting information and an 
explanation of the technical basis for each decision as follows. 
Records of the following decisions or activities must be retained for 
five years, consistent with recordkeeping requirements for existing 
regulations:
     Any decision to waive the 24-hour time limit for 
collecting repeat samples after a total coliform-positive routine 
sample, or to extend the 24-hour limit for collection of samples 
following invalidation, or for an unfiltered subpart H system of this 
part to collect a total coliform sample following a turbidity 
measurement exceeding 1 NTU.
     Any decision to allow a system to waive the requirement 
for three routine samples the month following a total coliform-positive 
sample. The record of the waiver decision must contain all the items 
listed in Sec. Sec.  141.854(j) and 141.855(f) of the proposed RTCR.
     Any decision to invalidate a total coliform-positive 
sample. If the State decides to invalidate a total coliform-positive 
sample as provided in Sec.  141.853(c)(1) of the proposed RTCR, the 
record of the decision must contain all the items listed in that 
paragraph.
     Completed and approved 40 CFR part 141 subpart Y 
assessments, including reports from the system that corrective action 
has been completed.

States must retain records of each of the following decisions in such a 
manner so that each system's current status may be determined at any 
time:
     Any decision to reduce the total coliform monitoring 
frequency for a community water system serving 1,000 or fewer people to 
less than once per month, as provided in Sec.  141.855(d) of the 
proposed RTCR; and what the reduced monitoring frequency is. A copy of 
the reduced monitoring frequency must be provided to the system.
     Any decision to reduce the total coliform monitoring 
frequency for a non-community water system using only ground water and 
serving 1,000 or fewer people to less than once per quarter, as 
provided in Sec.  141.854(e) of the proposed RTCR, and what the reduced 
monitoring frequency is. A copy of the reduced monitoring frequency 
must be provided to the system.
     Any decision to reduce the total coliform monitoring 
frequency for a non-community water system using only ground water and 
serving more than 1,000 persons during any month the system serves 
1,000 or fewer people, as provided in Sec.  141.857(d) of the proposed 
RTCR. A copy of the reduced monitoring frequency must be provided to 
the system.
     Any decision to waive the 24-hour limit for taking a total 
coliform sample for a public water system that uses surface water, or 
ground water under the direct influence of surface water, and that does 
not practice filtration in accordance with part 141, subparts H, P, T, 
and W, and that measures a source water turbidity level exceeding 1 NTU 
near the first service connection.
     Any decision to allow a public water system to forgo E. 
coli testing on a total coliform-positive sample if that system assumes 
that the total coliform-positive sample is E. coli- positive.

C. State Reporting Requirements

    EPA currently requires at 40 CFR 142.15 that States report to EPA 
information such as violations, variance and exemption status, and 
enforcement actions. The proposed RTCR requires States to develop and 
maintain a list of public water systems that the State is allowing to 
monitor less frequently than once per month for community water systems 
or less frequently than once per quarter for non-community water

[[Page 40956]]

systems, including the compliance date (the date that reduced 
monitoring was approved) of the reduced monitoring requirement for each 
system.

D. Interim Primacy

    On April 28, 1998, EPA amended its State primacy regulations at 40 
CFR 142.12 to incorporate the new process identified in the 1996 SDWA 
Amendments for granting primary enforcement authority to States while 
their applications to modify their primacy programs are under review 
(USEPA 1998c, 63 FR 23361, April 28, 1998). The new process grants 
interim primary enforcement authority for a new or revised regulation 
during the period in which EPA is making a determination with regard to 
primacy for that new or revised regulation. This interim enforcement 
authority begins on the date of the primacy application submission or 
the effective date of the new or revised State regulation, whichever is 
later, and ends when EPA makes a final determination. However, this 
interim primacy authority is only available to a State that has primacy 
(including interim primacy) for every existing NPDWR in effect when the 
new regulation is promulgated.
    As a result, States that have primacy (including interim primacy) 
for every existing NPDWR already in effect may obtain interim primacy 
for the RTCR, beginning on the date that the State submits the 
application for this rule to EPA, or the effective date of its revised 
regulations, whichever is later. A State that wishes to obtain interim 
primacy for future NPDWRs must obtain primacy for this rule.

E. Request for Comment

    EPA requests comment on the adequacy of the proposed RTCR 
requirements for State implementation, including but not limited to 
State special primacy requirements and State reporting and 
recordkeeping requirements. Specifically, EPA requests comment on 
whether there are any requirements that should be added to assure 
proper State oversight, or any that can be removed without detriment to 
implementation of the rule.

V. Distribution System Research and Information Collection Activities

A. Research and Information Collection Partnership

    The advisory committee recommended that a Research and Information 
Collection Partnership (RICP) be formed to inform and support the 
drinking water community in developing future national risk management 
decisions pertaining to drinking water distribution systems. The 
advisory committee recommended seven priority areas for research and 
information collection. These seven priority areas are: (1) Cross-
connection and backflow of contaminated water; (2) contamination due to 
storage facility design, operation, or maintenance; (3) contamination 
due to main installation, repair, or rehabilitation practices; (4) 
contaminant intrusion due to pressure conditions and physical gaps in 
distribution system infrastructure; (5) significance and control of 
biofilm and microbial growth; (6) nitrification issues that lead to 
public health effects; and (7) accumulation and release of contaminants 
from distribution system scales and sediments (USEPA 2008c, AIP p. 30).
    In January 2009, EPA and the Water Research Foundation (WRF or the 
Foundation) signed a memorandum of understanding (MOU) to form the RICP 
in response to recommendations from the advisory committee contained in 
the AIP (USEPA and WRF 2009). The MOU conveys the partners' agreement 
to collaborate and identify, define, prioritize, coordinate, and 
communicate critical decision-relevant distribution system research and 
information collection needs of the drinking water community. The RICP 
is directed by a steering committee comprised of nine members: Three 
members from EPA, three members from water utilities, and three 
additional members representing the public health, environmental 
advocate, and State regulator perspectives.
    The partners are developing a distribution system research and 
information collection agenda that focuses on characterizing and 
reducing public health risks. The identified priority information and 
research will allow better understanding and management of potential 
public health risks from drinking water distribution systems. See 
http://www.epa.gov/safewater/disinfection/tcr/regulation_revisions_
tcrdsac.html for further information on this effort.

B. Distribution System Optimization Activities

    As part of the AIP, the advisory committee encouraged ``the 
development of national and regional distribution system optimization 
partnerships that focus on protecting the integrity of drinking water 
quality once it is delivered to the distribution system. The purpose of 
the partnerships should be to inform and inspire proactive systems to 
implement best management practices that emphasize protection of public 
health. These partnerships, comprised, for example, of representatives 
from utilities, communities, academia, and regulatory organizations 
could develop continuous improvement programs that encompass water 
distribution optimization principles and practices for system design, 
operations, and maintenance. These partnerships should foster 
continuous review of distribution system issues and should define 
excellence in distribution system operation in terms of processes, 
systems, procedures, as well as measures. The optimization partnerships 
should encourage voluntary program participation of all drinking water 
utilities regardless of system size'' (USEPA 2008c, AIP p. 25).
    EPA is aware of two distribution system optimization programs that 
are currently being developed. EPA and the Foundation are concurrently 
developing distribution system optimization programs that focus on 
protecting public health in the distribution system. Developmental 
activities to support these efforts are occurring through the EPA's 
National Area Wide Optimization Program (AWOP) and the Foundation's 
project 4109. While these programs are being developed 
independently with differing measures of performance, both are founded 
on the optimization principles of improving water systems, and go 
beyond the regulatory requirements, while using existing staff and 
facilities. These principles and practices are currently being used 
through the in-plant treatment optimization programs operated through 
AWOP and the American Water Works Association's (AWWA) Partnership for 
Safe Water (the Partnership). For more information on the Partnership 
for Safe Water, see (http://www.awwa.org/Resources/
PartnershipforSafeWater.cfm?ItemNumber=3787&navItemNumber=33969).
    The goal of EPA's optimization program is to protect public health 
by addressing both the technical and management issues that limit the 
water system's ability to meet water quality performance goals. EPA has 
started developing a distribution system optimization program, which is 
currently focused on improving water treatment plant finished water 
quality while maintaining disinfectant residual and minimizing 
disinfection byproduct formation in the distribution system. Future 
work may focus on other water quality parameters or issues of concern. 
An outcome of this effort will be the identification of the key 
technical and management skills, practices, and tools

[[Page 40957]]

that a water system should implement to achieve long-term distribution 
system optimization. Ultimately, participating AWOP States will be 
introduced to distribution system optimization methods developed by 
EPA. At this time, additional development activities are needed before 
a distribution system optimization program will be available for State 
implementation.
    In 2007, the Foundation initiated project 4109 to identify 
a limited number of straightforward criteria that can be used by water 
utilities to measure distribution system optimization performance and 
to develop a self-assessment approach using standards of excellence. 
The results from this project will also be used to expand the 
Partnership for Safe Water Program treatment plant optimization program 
into distribution system optimization. The Foundation anticipates 
project 4109 to be completed by early 2010. With the results 
of project 4109, the Partnership anticipates finalizing a 
preliminary set of optimization goals and a model assessment process in 
calendar year 2010. Prior to finalizing the goals and assessment 
process, the Partnership will conduct trials at several volunteer 
utilities. The optimization goals and assessment process will be 
evaluated and refined based on those trials prior to consideration by 
the Partnership for adoption and implementation. AWWA anticipates that 
applications for the Partnership's Distribution System Optimization 
Program will be available in calendar year 2011.

C. Request for Comment

    EPA requests comment about these distribution system optimization 
projects and information about or suggestions for other possible 
approaches to distribution system optimization.

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

    This section summarizes the Health Risk Reduction and Cost Analysis 
(HRRCA) in support of the proposed RTCR as required by section 
1412(b)(3)(C) of the SDWA. EPA has prepared the RTCR Economic Analysis 
(EA) (USEPA 2010a) to comply with this requirement. The EA document for 
the proposed RTCR is available in the docket and is also published on 
the government's Web site at http://www.regulations.gov.
    The HRRCA consists of seven elements: (1) quantifiable and 
nonquantifiable health risk reduction benefits; (2) quantifiable and 
nonquantifiable health risk reduction benefits from reductions in co-
occurring contaminants; (3) quantifiable and nonquantifiable costs that 
are likely to occur solely as a result of compliance; (4) incremental 
costs and benefits of rule options; (5) effects of the contaminant on 
the general population and sensitive subpopulations including infants, 
children, pregnant women, elderly, and individuals with a history of 
serious illness; (6) any increased health risks that may occur as a 
result of compliance, including risks associated with co-occurring 
contaminants; and (7) other relevant factors such as uncertainties in 
the analysis and factors with respect to the degree and nature of risk. 
See SDWA section 1412(b)(3)(C). A summary of these elements is provided 
in this section of the preamble, and a complete discussion can be found 
in the Proposed RTCR EA (USEPA 2010a).
    The benefits described in this section are discussed qualitatively, 
and reductions in detection of total coliforms and E. coli and in Level 
2 assessments are used to describe the benefits, as described later in 
this section. The costs discussed in this section are presented as 
annualized present values in 2007 dollars. Both benefit and cost 
measures are adjusted using social discounting. In social discounting, 
future values of a rule's or policy's effects are multiplied by 
discount factors. The discount factors reflect both the amount of time 
between the present and the point at which these events occur and the 
degree to which current consumption is more highly valued than future 
consumption (USEPA 2000c). This process allows comparison of cost and 
benefit streams that are variable over a given time period. EPA uses 
social discount rates of both three percent and seven percent to 
calculate present values from the stream of benefits and costs and also 
to annualize the present value estimates. Historically, the use of 
three percent is based on rates of return on relatively risk-free 
financial instruments, while seven percent is generally an estimate of 
before-tax rate of return to incremental private investment. For 
further information, see USEPA 2000c and OMB 1996.
    In the Proposed RTCR EA (USEPA 2010a), EPA also presents the 
undiscounted stream of benefits and costs over the 25-year time frame 
(i.e., the year-to-year realization of benefits and costs presented in 
constant terms).
    The time frame used for both benefit and cost comparisons in this 
rule is 25 years. This time interval accounts for rule implementation 
activities occurring soon after promulgation (e.g., States adopting the 
criteria of the regulation) and the time for different types of 
compliance actions (e.g., assessments and corrective actions) to be 
realized up through the 25th year following rule promulgation.
    EPA was unable to quantify health benefits for the proposed RTCR 
because there are insufficient data reporting the co-occurrence in a 
single sample of fecal indicator E. coli and pathogenic organisms. In 
addition, the available fecal indicator E. coli data from the Six-Year 
Review 2 dataset (USEPA 2010e) described in this preamble were limited 
to presence-absence data because the current TCR requires only the 
reporting of presence or absence of fecal indicator E. coli using EPA-
approved standard methods. However, as discussed in chapter 6 of the 
Proposed RTCR EA (USEPA 2010a), even though health benefits could not 
be directly quantified, the potential benefits from the proposed RTCR 
include avoidance of a full range of health effects from the 
consumption of fecally contaminated drinking water, including the 
following: acute and chronic illness, endemic and epidemic disease, 
waterborne disease outbreaks, and death. Also, since fecal 
contamination may contain waterborne pathogens including bacteria, 
viruses, and parasitic protozoa, in general, a reduction in fecal 
contamination should reduce the risk from these other contaminants.
    The net costs of the rule stem mostly from the new assessment and 
corrective action requirements as well as the revised monitoring 
provisions described earlier in this preamble.
    This section of the preamble includes elements as follows: (A) 
Regulatory Options Considered, (B) Major Sources of Data and 
Information used in Supporting Analyses, (C) Occurrence and Predictive 
Modeling, (D) Baseline Profiles, (E) Anticipated Benefits of the 
Proposed RTCR, (F) Anticipated Costs of the Proposed RTCR, (G) 
Potential Impact of the Proposed RTCR on Households, (H) Incremental 
Costs and Benefits, (I) Benefits from Simultaneous Reduction of Co-
occurring Contaminants, (J) Change in Risk from Other Contaminants, (K) 
Effects of Fecal Contamination and/or Waterborne Pathogens on the 
General Population and Sensitive Subpopulations, (L) Uncertainties in 
the Benefit and Cost Estimates for the Proposed RTCR, (M) Benefit Cost 
Determination for the Proposed RTCR, and (N) Request for Comment.

A. Regulatory Options Considered

    EPA evaluated the following three regulatory options as part of 
this revised

[[Page 40958]]

rule proposal: (1) The current TCR option, (2) the AIP option, and (3) 
an Alternative option. EPA discusses the three regulatory options 
briefly in this preamble and in greater detail in chapter 3 of the 
Proposed RTCR EA (USEPA 2010a).
    First, the current TCR option reflects EPA's understanding of how 
the current TCR (USEPA 1989a, 54 FR 27544, June 29, 1989) is currently 
being implemented. That is, the current TCR option is assumed to 
include ``status quo'' PWS and State implementation practices. Next, 
the AIP option is a revised TCR based on the recommendations of the 
advisory committee. The provisions of this proposed rule are based on 
the AIP option and are described in detail in section III of this 
preamble. Third, the Alternative option parallels the AIP in most ways 
but includes variations of some of the provisions that were discussed 
by the advisory committee before consensus was reached on the AIP.
    The Alternative option differs from the AIP option in two ways. 
First, under the Alternative option, at the compliance date all PWSs 
are required to sample monthly for an initial period until they meet 
the eligibility criteria for reduced monitoring. EPA assumes that 
eligibility for reduced monitoring is determined during the next 
sanitary survey following the RTCR compliance date. This more stringent 
approach differs from the AIP option that allows PWSs to continue to 
monitor at their current frequencies (with an additional annual site 
visit or voluntary Level 2 assessment requirement for PWSs wishing to 
remain on annual monitoring) until they are triggered into an increased 
sampling frequency. Second, under the Alternative option, no PWSs are 
allowed to reduce monitoring to an annual basis. EPA defined the 
Alternative option this way and included it in the Proposed RTCR EA 
(USEPA 2010a) to assess the relative impacts of a more stringent rule 
and to better understand the balance between costs and public health 
protection.
    To understand the relative impacts of the options, EPA gathered 
available data and information to develop and provide input into an 
occurrence and predictive model. EPA estimated both baseline conditions 
and changes to these conditions anticipated to occur over time as a 
result of these revised rule options. The analysis is described in more 
detail in the Proposed RTCR EA (USEPA 2010a).

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

    This section of the preamble briefly discusses the data sources 
that EPA used in its supporting analyses for the proposed RTCR. For a 
more detailed discussion, see chapter 4 of the Proposed RTCR EA (USEPA 
2010a).
1. Safe Drinking Water Information System Federal Version Data
    Safe Drinking Water Information System Federal Version (SDWIS/FED) 
is EPA's national regulatory compliance database for the drinking water 
program and is the main source of PWS inventory and violation data for 
the proposed RTCR baseline. SDWIS/FED contains information on each of 
the approximately 155,000 active PWSs as reported by primacy agencies, 
EPA Regions, and EPA headquarters personnel. SDWIS/FED includes records 
of MCL violations and monitoring and reporting (MR) violations (both 
routine and repeat and minor and major). It does not include sample 
results. It also contains information to characterize the US inventory 
of PWSs including system name and location, retail population served, 
source water type (ground water (GW), surface water (SW), or ground 
water under the direct influence of surface water (GWUDI)), 
disinfection status, and PWS type (community water system (CWS), 
transient non-community water system (TNCWS), and 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 Proposed RTCR 
EA. These data represent all current, active PWSs and the population 
served by these systems.
    EPA also used the MCL violation data from SDWIS/FED to validate 
model predictions for systems serving 4,100 or fewer people and to 
predict E. coli (acute)---MCL violations (current TCR, AIP, and 
Alternative option), total coliform (non-acute or monthly) MCL 
violations (current TCR), and Level 1 and Level 2 assessment triggers 
(AIP and Alternative option) for systems serving more than 4,100 
people.
2. Six-Year Review 2 Data
    Through an Information Collection Request (USEPA 2006b), States 
voluntarily submitted electronically available TCR monitoring data 
(sample results) that were collected between January 1998 and December 
2005. EPA requested the TCR monitoring results with the intent of 
conducting analyses and developing models to assess the potential 
impacts of changes to the current TCR. EPA received data from 46 
States, Tribes, and territories. A Data Quality Report (USEPA 2010c) 
describes how TCR monitoring data were obtained, evaluated, and 
modified where necessary to make the database internally consistent and 
usable for analysis. Exhibit 2.1 in the Data Quality Report provides a 
complete list of States or territories that submitted data and a 
description of the use of these data.
    In this EA, EPA included data from 37 primacy agencies (35 States 
and 2 Tribes). Records included data for:
     PWS information (system type, population served, source 
water type)
     Sample type (routine, repeat, special purpose)
     Analytical result
     Sampling location--entry point, distribution system and, 
for repeat samples, original location, downstream, upstream, and other
     Analytical method
     Disinfectant residual data collected at TCR monitoring 
sites
    As discussed in greater detail in section 4.2.2.1 of the Proposed 
RTCR EA (USEPA 2010a), EPA used 2005 data exclusively in the analyses 
supporting the proposed RTCR because the 2005 data set was the most 
complete year of data among the Six-Year Review 2 data (USEPA 2010e). 
The 2005 data was also the most recent data available suggesting that 
it may be the most representative of present conditions.
    The Six-Year Review 2 data (USEPA 2010e) also informed EPA's 
assumptions regarding the proportions of GWSs serving 1,000 or fewer 
people that sample monthly, quarterly, or annually.
3. Other Information Sources
    Additional data and information sources included the Economic 
Analysis for the Ground Water Rule (GWR EA) (USEPA 2006a), the 
Technology and Cost Document for the Proposed Revised Total Coliform 
Rule (proposed RTCR T&C document) (USEPA 2010b), the U.S. Census data, 
and the knowledge and experience of stakeholders representing industry, 
States, small systems, and the public.
    The GWR EA provided occurrence information on E. coli in the source 
water of ground water PWSs for modeling the triggered monitoring 
component of GWR and informed the assumptions on the distribution of 
corrective actions taken in response to the presence of E. coli in the 
source water. As discussed in section VI.C.1 of

[[Page 40959]]

this preamble, the model developed for this economic analysis considers 
the effect of GWR both before and during implementation of the proposed 
revised rule. The proposed RTCR T&C document included estimates of unit 
costs for the major components of the proposed RTCR including labor, 
monitoring, assessments, and corrective actions. U.S. Census data were 
used to estimate population per household and to characterize sensitive 
subpopulations. Lastly, knowledge and experience from stakeholders 
helped to inform the assumptions that were made for the analysis.
    A more detailed discussion of these data sources and how EPA used 
them are included in the Proposed RTCR EA (USEPA 2010a).

C. Occurrence and Predictive Modeling

    EPA used the data to develop an occurrence and predictive model for 
PWSs serving 4,100 or fewer people based primarily on the 2005 Six-Year 
Review 2 data (USEPA 2010e). The model predicts changes in total 
coliform and E. coli occurrence, Level 1 and Level 2 assessments (based 
on simulated monitoring results), corrective actions, and violations 
over time. EPA developed another, simpler, predictive model, for PWSs 
serving more than 4,100 people, that predicts Level 1 and Level 2 
assessments (based on 2005 violation data from SDWIS/FED), corrective 
actions, and violations over time, but not total coliform and E. coli 
occurrence. EPA modeled systems serving more than 4,100 people 
separately because the Six-Year Review 2 data (USEPA 2010e) for larger 
PWSs were not as robust as the data for the smaller systems. In 
addition, while EPA is proposing new monitoring requirements for PWSs 
serving 4,100 people or fewer, proposed monitoring requirements for 
systems serving greater than 4,100 people remain essentially unchanged. 
This section briefly discusses the structures of each of the two models 
and how they used available data, information, and assumptions to make 
predictions over time resulting from the proposed regulatory options.
    Chapter 5 of the Proposed RTCR EA (USEPA 2010a) includes a more 
detailed description of the occurrence and predictive model used for 
PWSs serving 4,100 or fewer people, and the other simpler predictive 
model used for PWSs serving greater than 4,100 people.
1. Model Used for Public Water Systems Serving 4,100 or Fewer People
    The occurrence and predictive model used for PWSs serving 4,100 or 
fewer people has two components. The first component of the model 
characterized how the presence or positive rates of total coliform and 
E. coli detections vary across the population of small (serving 4,100 
or fewer people) public water systems in the U.S. These rates vary by 
the type of sample (routine or repeat), by analyte (total coliforms or 
E. coli), and by system type (CWS, NCWS, or TNCWS) and size. The second 
component of the model used the total coliform and E. coli occurrence 
distributions to simulate a set of nationally-representative systems 
within the context of the three regulatory options (TCR, AIP, and 
Alternative) to predict changes in total coliform and E. coli 
occurrence, triggers, assessments, corrective actions over time, and 
violations.
    The model assumed that the national occurrence of total coliforms 
and E. coli has reached a steady state in recent years under the 
current TCR. It assumed that cycles of normal deterioration and repair/
replacement are occurring at the individual system level. However, the 
numbers of violations at the national level have remained relatively 
unchanged. This assumption is based on evaluation of SDWIS/FED 
violation data. Exhibit VI-1 presents the number of PWSs with TCR 
violations over the last several years which shows that national 
violation rates have remained relatively steady over the past several 
years. Revisions to the TCR affect this steady state, likely resulting 
in a reduction of the underlying occurrence and associated violations. 
However, before the RTCR goes into effect, GWR implementation begins 
which is also expected to affect the steady state.
[GRAPHIC] [TIFF OMITTED] TP14JY10.001

[[Page 40960]]

    To estimate the effects that GWR implementation is expected to have 
on present steady state conditions, EPA used the occurrence and 
predictive model to simulate five years of implementation of the 
current TCR with the GWR, which became effective in December 2009. EPA 
assumed these five years to account for the approximately two years 
before the expected promulgation date of the final RTCR and an 
additional three years after that until the RTCR effective date. The 
assumptions made to account for the GWR are described in detail in the 
Proposed RTCR EA (USEPA 2010a) and summarized in Exhibit VI-2.

      Exhibit VI-2--Summary of Major Assumptions for Simulating GWR
                             Implementation
------------------------------------------------------------------------
             GWR provision                Modeling approach/ assumption
------------------------------------------------------------------------
Triggered Monitoring: GWSs not           Current model used same
 providing 4-log treatment for viruses    probabilities used in GWR EA
 that have total coliform-positive        (USEPA 2006a) to predict
 samples under current TCR are required   whether source water samples
 to take source water samples and test    will be E. coli-positive.
 for fecal indicator. If the sample is   GWSs required to conduct
 positive, they must take an additional   corrective action due to
 5 source water samples (unless the       monitoring results will either
 State requires corrective action). If    install disinfection or
 any of these is positive, they must      implement a nondisinfecting
 conduct corrective action.               corrective action as described
                                          in Proposed RTCR EA (USEPA
                                          2010a).
                                         GWSs installing disinfection
                                          will draw from the probability
                                          distributions for total
                                          coliforms and E. coli for
                                          disinfected systems for the
                                          remainder of analysis.
                                         GWSs implementing a
                                          nondisinfecting corrective
                                          action will experience no
                                          positive samples for the
                                          remainder of the year plus two
                                          additional years and will
                                          experience a 75 \1\ percent
                                          reduction in occurrence for
                                          five additional years.

Sanitary Surveys: GWR includes Federal   Model did not explicitly
 sanitary survey requirements for all     simulate sanitary surveys or
 GWSs, and requires States to perform     their results. Rather, it
 regular comprehensive sanitary surveys   assumed that the new sanitary
 including eight critical elements.       survey provisions will result
                                          in 10 percent \2\ reduced
                                          occurrence of total coliforms
                                          universally for entire
                                          analysis.
Compliance Monitoring: GWSs that         Model did not explicitly
 provide 4-log treatment for viruses      simulate compliance
 must demonstrate that they are           monitoring. Rather, it assumed
 providing this level of treatment by     that the provision will result
 conducting compliance monitoring..       in 10 percent \3\ reduced
                                          occurrence of total coliforms
                                          for those GWSs that are
                                          conducting compliance
                                          monitoring once assumed 4-log
                                          treatment for viruses begins
------------------------------------------------------------------------
1, 2, 3 Assumption reflects EPA best professional judgment.
Source: Proposed RTCR EA (USEPA 2010a) as informed by GWR EA (USEPA
  2006a).

    Actual reductions in occurrence that are expected to result from 
the implementation of GWR requirements may differ from what is 
presented here. However, based on assumptions used in this model, the 
analysis of how the AIP and Alternative option perform relative to each 
other are not affected.
    In addition to capturing the effect of implementation of GWR 
requirements with the current TCR for a five-year period of analysis, 
the model captures an additional 25 years with the current TCR, the AIP 
option, and the Alternative option. Along with changes in total 
coliform and E. coli occurrence, the model predicts behavioral changes: 
The number of Level 1 and Level 2 assessments (and associated Level 1 
or Level 2 corrective actions) to be performed, further resulting 
adjustments to occurrence, and changes in sampling regimens as systems 
qualify for reduced monitoring requirements. The assumptions used to 
simulate RTCR implementation are detailed in the Proposed RTCR EA 
(USEPA 2010a) and summarized in Exhibit VI-3.

 Exhibit VI-3--Summary of Major Assumptions for Simulating Proposed RTCR
                             Implementation
------------------------------------------------------------------------
   Proposed RTCR provision            Modeling approach/assumption
------------------------------------------------------------------------
Level 1 Assessment...........  Model simulates sampling and sampling
                                results and determines which PWSs will
                                be triggered to conduct an assessment.
                               Sanitary defects are found in 10 percent
                                \1\ of assessments (represents net
                                increase over current TCR).
                               All sanitary defects are corrected. Model
                                selects from distribution of potential
                                corrective actions as explained in
                                chapter 7 of the Proposed RTCR EA (USEPA
                                2010a).
                               PWSs implementing a corrective action as
                                a result of a Level 1 assessment
                                experience no positive samples for the
                                remainder of the year plus one
                                additional year and will experience 50
                                percent \2\ reduction in occurrence for
                                three additional years.
Level 2 Assessment...........  Model simulates sampling and sampling
                                results and determines which PWSs will
                                be triggered to conduct an assessment.
                               Sanitary defects will be found in 10
                                percent \3\ of assessments (represents
                                net increase over current TCR).
                               All sanitary defects are corrected. Model
                                selects from distribution of potential
                                corrective actions as explained in
                                chapter 7 of the Proposed RTCR EA (USEPA
                                2010a).
                               PWSs implementing a corrective action as
                                a result of a Level 2 assessment will
                                experience no positive samples for the
                                remainder of the year plus two
                                additional years and will experience 75
                                percent \4\ reduction in occurrence for
                                five additional years.
------------------------------------------------------------------------
1 3 Assumption based on conversation with State representatives with on-
  the-ground experience.
2 4 Assumption reflects EPA best professional judgment.

[[Page 40961]]

Note: EPA recognizes that there is a large uncertainty with the
  assumptions. Sensitivity analyses showed that the fundamental
  conclusions of the economic analysis do not change over a wide range
  of assumptions tested.
Source: Proposed RTCR EA (USEPA 2010a).

    EPA made different assumptions for the effectiveness of assessments 
and subsequent corrective actions to account for the differences 
between the two types of assessments. The Level 2 assessment is a more 
comprehensive investigation that may result in finding more substantial 
problems than what may be found during a Level 1 assessment, and for 
that reason the corrective actions that result from a Level 2 
assessment were modeled to have bigger and longer lasting effects than 
those of the Level 1 assessments. EPA conducted sensitivity analyses 
around the key assumptions summarized in Exhibit VI-2 as discussed in 
section VI.L of this preamble.
2. Model Used for Public Water Systems Serving More Than 4,100 People
    For systems serving more than 4,100 people, EPA estimated violation 
and trigger rates using SDWIS/FED because the Six-Year Review 2 data 
(USEPA 2010e) for PWSs serving more than 4,100 people were not as 
robust as the Six-Year Review 2 data (USEPA 2010e) for systems serving 
4,100 or fewer people. EPA did not quantify changes in violation or 
trigger rates for systems serving more than 4,100 people among the 
current TCR, AIP, and Alternative options because of: (1) Limited Six-
Year Review 2 data (USEPA 2010e) to characterize these systems, (2) the 
essentially unchanged monitoring requirements across options for these 
systems, and (3) the level of effort already occurring to implement the 
TCR.

D. Baseline Profiles

    The estimate of baseline conditions that EPA developed provides a 
reference point for understanding net impacts of the proposed rule 
revisions.
    Compliance with the GWR begins in December 2009, and the expected 
compliance date of the RTCR is approximately five years following 
commencement of the GWR implementation. The majority of PWSs are GWSs 
and these systems are expected to be affected by the GWR. Because GWR 
implementation prior to the effective date of RTCR is expected to cause 
changes to GWSs, the baseline conditions that EPA developed for GWSs 
account for the expected effects of the GWR.
    For PWSs serving more than 4,100 people, EPA assumed that present 
conditions, as reflected in 2005 SDWIS/FED data, are an appropriate 
representation of the conditions that are likely to exist when the RTCR 
becomes effective. EPA assumed that a steady state exists at the 
national level.
    The number of GW PWSs that disinfect is expected to change during 
implementation of the GWR before the expected rule compliance date of 
the proposed RTCR. Exhibit VI-4 shows the estimated baseline number of 
the GW PWSs at the proposed RTCR compliance date.
[GRAPHIC] [TIFF OMITTED] TP14JY10.002

    EPA estimated the numbers of GW PWSs that monitor monthly, 
quarterly, and annually under the current TCR based on an analysis of 
the Six-Year Review 2 data (USEPA 2010e) and individual State statutes 
conducted by EPA and the advisory committee Technical Work Group (TWG). 
Of the GW PWSs serving 1,000 or fewer people, EPA estimated that 
approximately 34,000 monitor monthly, 67,000 monitor quarterly, and 
27,000 monitor annually. EPA assumed that the numbers of systems on 
monthly, quarterly, and annual monitoring remain unchanged at the rule 
effective date for either a continuation of the current TCR or for the 
AIP option. Under the Alternative option, all PWSs, regardless of size 
or type, start at monthly monitoring at the rule effective date.
    The following two tables provide an overview of summary statistics 
relating to baseline water quality. Exhibit VI-5 shows the percentage 
of total 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

[[Page 40962]]

systems than in surface water systems; in smaller systems than in 
larger systems; and in NCWSs than in CWSs.
BILLING CODE 6560-50-P
[GRAPHIC] [TIFF OMITTED] TP14JY10.003

BILLING CODE 6560-50-C

[[Page 40963]]

    Exhibit VI-6 presents the number of acute and non-acute violations 
received by PWSs. The number of violations is also an indicator of 
baseline water quality prior to implementation of the proposed RTCR. As 
discussed in detail in chapter 5 of the Proposed RTCR EA (USEPA 2010a), 
EPA used these data to estimate the numbers of MCL violations and 
triggers for PWSs serving more than 4,100 people for the three options. 
Under the current TCR, larger systems incur a relatively small number 
of violations annually, while smaller systems incur the majority.

                                     Exhibit VI-6--Baseline Number of TCR Violations by System Size and Type (2005)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              GW PWSs                                SW PWSs
                                                              ------------------------------------------------------------------------------   All PWSs
                                                                Non-acute      Acute        Total      Non-acute      Acute        Total        total
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          CWSs
--------------------------------------------------------------------------------------------------------------------------------------------------------
<= 100.......................................................          905           52          957           16            3           19          976
101-500......................................................          809           34          843           50            7           57          900
501-1,000....................................................          203           13          216           16            3           19          235
1,001-3,300..................................................          272            8          280           55            7           62          342
3,301-10,000.................................................          171            8          179           75            3           78          257
10,001-50,000................................................          125            8          133           78            4           82          215
50,001-100,000...............................................           11            2           13            5            4            9           22
100,001-1 Million............................................            1            1            2            3            1            4            6
> 1 Million..................................................  ...........  ...........  ...........            1  ...........            1            1
                                                              ------------------------------------------------------------------------------------------
    Totals...................................................        2,497          126        2,623          299           32          331        2,954
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         NTNCWSs
--------------------------------------------------------------------------------------------------------------------------------------------------------
<= 100.......................................................          514           34          548            7            2            9          557
101-500......................................................          346           20          366            4  ...........            4          370
501-1,000....................................................           57            6           63            2  ...........            2           65
1,001-3,300..................................................           58            4           62  ...........  ...........  ...........           62
3,301-10,000.................................................            9            2           11            1  ...........            1           12
10,001-50,000................................................            1  ...........            1  ...........  ...........  ...........            1
50,001-100,000...............................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........
100,001-1 Million............................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........
> 1 Million..................................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........
                                                              ------------------------------------------------------------------------------------------
    Totals...................................................          985           66        1,051           14            2           16        1,067
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         TNCWSs
--------------------------------------------------------------------------------------------------------------------------------------------------------
<= 100.......................................................        2,665          278        2,943           19            5           24        2,967
101-500......................................................          833           76          909           11            1           12          921
501-1,000....................................................          133           11          144            4  ...........            4          148
1,001-3,300..................................................           58            2           60            1  ...........            1           61
3,301-10,000.................................................            5  ...........            5            1  ...........            1            6
10,001-50,000................................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........
50,001-100,000...............................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........
100,001-1 Million............................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........
> 1 Million..................................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........
                                                              ------------------------------------------------------------------------------------------
    Totals...................................................        3,694          367        4,061           36            6           42        4,103
                                                              ------------------------------------------------------------------------------------------
        Grand Total..........................................        7,176          559        7,735          349           40          389        8,124
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: The proposed RTCR EA uses violations data for PWSs serving greater than 4,100 people to estimate triggers for these systems. Data for other system
  sizes is provided for reference.
Source: SDWIS/FED 2005 3rd quarter data. OH, U.S. territories, Tribal PWS data excluded. See the Proposed RTCR EA (USEPA 2010a) for additional details.

E. Anticipated Benefits of the Proposed RTCR

    In promulgating the RTCR, EPA expects to further reduce the risk of 
contamination of public drinking water supplies from the current 
baseline risk under the current TCR. The options considered during 
development of this proposed rule and analyzed as part of the Proposed 
RTCR EA (USEPA 2010a) are designed to achieve this reduction while 
maintaining public health protection in a cost-effective manner.
    This section examines the benefits in terms of trade-offs among 
compliance with the current TCR option, the AIP option, and the 
Alternative option. Because there are insufficient data reporting the 
co-occurrence in a single sample of fecal indicator E. coli and 
pathogenic organisms and because the available fecal indicator E. coli 
data from the Six-Year Review 2 dataset (USEPA 2010e) were limited to 
presence-absence data, EPA was unable to quantify health benefits for 
the proposed RTCR. EPA used several methods to qualitatively evaluate 
the benefits of the proposed RTCR options. The qualitative evaluation 
uses both the judgment of EPA as informed by the TCRDSAC deliberations 
as well as quantitative estimates of changes in total coliform 
occurrence and counts of systems implementing corrective actions. The 
evaluation characterizes, in relative terms, the reduction in risk for 
each regulatory scenario as compared to baseline conditions.

[[Page 40964]]

    Since E. coli is an indicator of fecal contamination, EPA assumed 
that a decrease in E. coli occurrence in the distribution system would 
be associated with a decrease in fecal contamination in the 
distribution system. In general, this decrease in fecal contamination 
should reduce the potential risk to human health for PWS customers. 
Thus, any reduction in E. coli occurrence is considered a benefit of 
the proposed RTCR. Also, since fecal contamination may contain 
waterborne pathogens including bacteria, viruses, and parasitic 
protozoa, in general, a reduction in fecal contamination should also 
reduce the risk from these other contaminants.
    As presented in Exhibit VI-5, the percentages of samples that are 
positive for total coliforms and E. coli are generally higher for PWSs 
serving 4,100 or fewer people than those serving more than 4,100 
people. PWSs with higher total coliform and E. coli occurrence are more 
likely to be triggered into assessments and corrective action. As 
discussed previously, the assessments and corrective action lead to a 
decrease in total coliform and E. coli occurrence. Because the PWSs 
serving 4,100 or fewer people have a higher initial E. coli occurrence 
and are likely triggered into more assessments and corrective actions 
than larger PWSs, the increase in benefits for these small systems are 
likely more evident as compared to the larger systems. In particular, 
model results suggest that customers of small ground water TNCWSs 
serving 100 or fewer people, which constitute approximately 40 percent 
of PWSs, experience the most improvement in water quality under the 
proposed RTCR. That is, the occurrence of E. coli is predicted to 
decrease more for these systems than for other systems types.
1. Relative Risk Analysis
    When revising an existing drinking water regulation, one of the 
main concerns is to ensure that backsliding on water quality and public 
health protection does not occur. SDWA requires that EPA at least 
maintain or improve public health protection for any rule revision. The 
proposed RTCR is more stringent that the current TCR with regard to 
protecting public health. The basis for this perspective is provided in 
this subsection and the following subsections (sections VI.E.1-3) of 
this preamble.
    Risk reduction for the proposed RTCR is characterized by the 
activities performed that are presumed to reduce risk of exposing the 
public to contaminated water. These activities are considered under 
each rule component presented in Exhibit VI-8.
    More frequent monitoring has the potential to decrease the risk of 
contamination in PWSs based on an enhanced ability to diagnose and 
mitigate system issues in a more timely fashion. Conversely, less 
frequent monitoring has the potential to increase risk. Real-time 
continuous sampling would mitigate the most risk possible based on 
sampling schedule; however, it would cost prohibitively more than the 
periodic sampling practiced under the current TCR and included in the 
AIP and the Alternative options. EPA's objective in proposing the 
sampling schedules included in the AIP and Alternative options was to 
find an appropriate balance between the factors of risk mitigation and 
cost management.
    Under the AIP and Alternative options, the reduction in the number 
of repeat samples and additional routine samples for some PWSs has the 
potential to contribute to increased risk for PWS customers (see also 
sections III.A.3 and III.A.4 of this preamble for discussions on the 
repeat sample and additional routine sample provisions respectively). 
However, this increase in risk is expected to be more than offset by 
potential decreases in risk from increased routine monitoring (see 
section III.A.3 of this preamble) and the addition of the assessments 
and corrective action provisions (see section III.A.5 of this preamble) 
that find and fix problems indicated by monitoring. Exhibit VI-7 
illustrates the predicted reduced frequency at which total coliforms 
occur subsequent to the implementation of the AIP and Alternative 
options. As discussed previously, the proposed RTCR uses total coliform 
occurrence as an indicator of potential pathways for possible 
contamination to enter the distribution system (see section III.A.2 of 
this preamble). Exhibit VI-7 illustrates the combined effects on total 
coliform occurrence resulting from changes in monitoring and the 
effects of assessments and corrective actions for the different rule 
options illustrated. The relative trends indicated in Exhibit VI-7 for 
transient non-community water systems also pertain to other PWS 
categories as illustrated in chapter 5 of the Proposed RTCR EA (USEPA 
2010a). EPA chose to include the characterization for TNCWSs because 
they represent the system category of largest influence on the national 
impacts.

[[Page 40965]]

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    The effect that the proposed changes to public notification 
requirements for monthly/non-acute MCL violations have on risk is 
difficult to predict. Some factors, such as reduction in available 
public information and possible PWS complacency, lead to a potential 
increase in risk and other factors, such as less confusion (PN more in 
line with potential health risks) and PWSs resources used more 
efficiently, lead to a potential decrease, as discussed in Exhibit VI-
8. This change to PN is addressing a key concern expressed by various 
stakeholders in the advisory committee and during the Six-Year Review 1 
comment solicitation process. By eliminating the requirement and 
replacing it with assessment and corrective action requirements, the 
Agency expects less public confusion, more effective use of resources, 
and increased transparency. Other proposed rule components are expected 
to have a negligible effect on risk. However, the overall effect of the 
proposed RTCR is expected to be a further reduction in risk from the 
current baseline risk under the current TCR. Chapter 6 of the Proposed 
RTCR EA (USEPA 2010a) presents a detailed discussion of the potential 
influence on health risk for each proposed rule component.
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2. Changes in Violation Rates and Corrective Actions
    The quantified portion of the benefits analysis focuses on several 
measures that contribute to the changes in risk expected under the 
proposed RTCR. Specifically, EPA modeled the predicted outcomes based 
on each regulatory option considered--baseline (current TCR), the AIP, 
and the Alternative option--in the form of estimates of non-acute 
violations for the current TCR and assessment triggers for the AIP and 
Alternative option; E. coli violations; and the number of corrective 
actions implemented under each option. This section of the preamble 
includes six graphs (Exhibit VI-9 through Exhibit VI-14) that help to 
illustrate these endpoints.
    Evaluation of each of these endpoints informed EPA's understanding 
of potential changes to the underlying quality of drinking water. In 
particular, the number of corrective actions performed has a strong 
relationship to potential improvements in water quality and public 
health. For a given rate of total coliform and E. coli occurrence, an 
increase in the number of corrective actions implemented leads to 
improved water quality. However, a reduction in sampling likely leads 
to a reduction in total coliform and E. coli positives being found, 
which in turn likely leads to a reduction in assessments and corrective 
actions being implemented. The number of total coliform and E. coli 
positives that are prevented, missed, or found under each regulatory 
option considered in comparison to those predicted under the current 
TCR results in estimates of annual non-acute and acute violations 
(current TCR) and assessment triggers (AIP and Alternative options). 
Section 6.4 of the Proposed RTCR EA (USEPA 2010a) presents a step-wise 
sensitivity analysis of the competing effects of additional protective 
activity (e.g., assessments and corrective actions) and decreased 
additional routine and repeat sampling of the regulatory alternatives 
compared to the current TCR. The results of this sensitivity analysis 
showed that for all categories of systems, more total coliform and E. 
coli positives are prevented than missed under both regulatory options.
    For each of the graphs presented in Exhibit VI-9 through Exhibit 
VI-14, there are two main model drivers that affect the endpoints 
depicted: The total

[[Page 40968]]

number of samples taken over time (including routine, additional 
routine, and repeat samples) and the effect of corrective actions 
taken. When looking at the comparisons between the TCR with the AIP 
across all PWSs, the overall effect of the total numbers of samples 
taken is negligible because the total number of samples predicted to be 
taken throughout the period of analysis is almost the same 
(approximately 82 million samples) under both the TCR and AIP. For the 
Alternative option, the analysis predicts that approximately 87 million 
total samples are taken over the period of analysis. Exhibit VI-18 of 
this preamble presents estimated total numbers of samples taken over 
the 25-year period of analysis. Based on the relationships of total 
samples taken among the TCR, AIP, and Alternative options, the best way 
to interpret the graphs presented in this section is in a step-wise 
manner.
    The first comparison that should be made is between the current TCR 
and AIP options. Because similar total numbers of samples are taken 
under each option, the major effect seen in the graphs can be isolated 
to the effects that implementation of corrective actions has on 
underlying occurrence and how that occurrence influences the endpoint 
in question (assessments, E. coli MCL violations, and corrective 
actions). In each graph, this is depicted by a marked reduction in the 
endpoint under the AIP option compared to the current TCR option and is 
a reflection of overall better water quality. The second comparison can 
then be made of the Alternative option against the AIP option. In each 
graph, the predicted results (assessments, E. coli MCL violations, and 
corrective actions) for the Alternative option are above those for the 
AIP option and represent an additional benefit over the AIP option. 
This additional benefit is primarily a function of the additional 
diagnostic abilities gained through increased monitoring under the 
Alternative option, and is especially prominent in the early years of 
the analysis when all systems are required to monitor at least monthly.
    More detailed descriptions of each endpoint considered in terms of 
the evaluation process described previously are provided in this 
section as they apply to the individual graphs in Exhibit VI-9 through 
VI-14. Each of the graphs shown in this section is presented first in 
nondiscounted terms, and then based on a discount rate of three percent 
to reflect the reduced valuation of potential benefits over time, 
consistent with the presentation of costs in the section that follows. 
Graphs of benefits discounted using seven percent discounted rates are 
presented in Appendix B of the Proposed RTCR EA (USEPA 2010a).
    Exhibit VI-9 shows the effect (on average across all PWSs) of the 
AIP and the Alternative options on the annual number of non-acute 
violations (TCR) and assessment triggers (AIP and Alternative options) 
over time. The estimated reduction of annual assessment triggers (from 
the current TCR estimates of non-acute violations) by approximately 
1,000 events under the AIP option is a reflection of the improved water 
quality expected under the AIP option. A similar but smaller reduction 
in non-acute violations (Level 1 triggers) from the current TCR is seen 
under the Alternative option. The larger initial estimate of assessment 
triggers followed by a higher steady state number for the Alternative 
option than seen under the AIP option reflects the diagnostic abilities 
provided by increased sampling under the Alternative option. The 
additional triggers identified by increased sampling under the 
Alternative option translate into greater potential benefits than under 
the AIP option.
    Exhibit VI-10 shows the effect (on average across all PWSs) of the 
AIP and the Alternative option with respect to E. coli violations found 
over the 25-year period of analysis in comparison to the current TCR. 
The overall reduction in annual E. coli violations under the AIP option 
of more than 100 events is a measure that should correlate more closely 
with expected benefits (that is, reductions in adverse health outcomes) 
than non-acute events (as presented in Exhibit VI-9) because E. coli 
violations are a direct result of measurement of fecal contamination in 
water. A similar but smaller reduction is seen under the Alternative 
option after steady state is achieved. This is the result of two 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 AIP, 
even though the underlying ``true'' number of violations is lower. This 
lower number of ``true'' violations means that the Alternative option 
is more protective of public health, even though more violations are 
detected.
    Exhibit VI-11 presents estimates over the 25-year period of 
analysis of the increase in corrective actions (on average across all 
PWSs) attributable to the regulatory options considered. Performance of 
these additional corrective actions is expected to result in the most 
direct benefits under the proposed RTCR. Because only the incremental 
numbers of corrective actions estimated under the AIP and Alternative 
options were modeled, the reference point for comparison to the current 
TCR is the base (zero) line in the graph. The Proposed RTCR EA (USEPA 
2010a) assumes that corrective actions are already being performed 
under the current TCR. Baseline corrective actions are taken into 
account by assuming only a modest incremental increase of 10 percent in 
implementation of effective corrective actions under both regulatory 
options considered.
    Exhibit VI-11 indicates that more corrective actions are 
implemented under the Alternative option than under the AIP option. 
This is driven, again, by the increased diagnostic power of more 
sampling and reflects additional potential benefits beyond those gained 
under the AIP option.
    Taken together, Exhibit VI-9 through Exhibit VI-11 indicate that 
the modeled endpoints for the AIP and Alternative options predict 
positive benefits in comparison to the current TCR; in particular, the 
Alternative option captures more benefits than the AIP option. Similar 
to the patterns seen in Exhibits VI-9 through VI-11, for each of the 
discounted endpoints presented over time in Exhibits VI-12 though VI-
14, the graphs show that (on average across all PWSs) the Alternative 
option provides more benefit than the AIP, and both provide more 
benefit than the current TCR. These outcomes are consistent with the 
qualitative assessment of the benefits summarized in section VI.E.1.
    The major difference between the AIP option and Alternative option 
is the increased monitoring that is required under the Alternative 
option. The increased diagnostic ability of the extra samples taken 
under the Alternative option is seen in the large difference in the 
endpoint counts through the first several years in Exhibit VI-9 through 
Exhibit VI-14. Absent this effect, the Alternative option essentially 
mirrors the AIP option in the exhibits. Even though the predicted 
results (assessments, E. coli MCL violations, and corrective actions) 
under the Alternative option are greater than the current TCR at first, 
the trend is due to initially finding more problems through monitoring. 
The increased monitoring during the first several years under the 
Alternative option results in a frontloading of benefits at the 
beginning

[[Page 40969]]

of the implementation period. The benefits, however, tend to even out 
over time between the AIP and Alternative option as eligible systems 
qualify for less intense (quarterly) monitoring under the Alternative 
option. However, the Alternative option leads to a greater number of 
assessments, E. coli MCL violations, and corrective actions than the 
AIP option because all PWSs are required to sample no less than 
quarterly under the Alternative option while under the AIP option 
qualifying PWSs are permitted to sample at a minimum of once per year 
(more monitoring has the potential for more triggered assessments, 
corrective actions, and/or violations than less monitoring).
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3. Nonquantifiable Benefits
    a. Potential decreased incidence of endemic illness from fecal 
contamination, waterborne pathogens, and associated outbreaks. As 
discussed in section VI of this preamble and chapter 2 of the Proposed 
RTCR EA (USEPA 2010a), benefits from the proposed RTCR may include 
avoidance of a full range of health effects from the consumption of 
fecally contaminated drinking water, including the following: Acute and 
chronic illness, endemic and epidemic disease, waterborne disease 
outbreaks, and death. EPA recognizes that the EPA-approved standard 
methods available for E. coli do not typically identify the presence of 
the pathogenic E. coli strains, such as E. coli O157:H7. Thus, E. coli 
occurrence, as used in this EA, serves as an indication of fecal 
contamination but not necessarily pathogenic contamination. See also 
discussion in sections III.A.2 and III.A.9 of this preamble.
    EPA was unable to quantify the cases of morbidity or mortality 
avoided because there are insufficient data reporting the co-occurrence 
of fecal indicator E. coli and pathogenic organisms in a single water 
sample, and because the available fecal indicator E. coli data from the 
Six-Year Review 2 dataset (USEPA 2010e) were limited to presence-
absence data. Instead, EPA estimated changes in total coliform and 
fecal indicator E. coli occurrence (for systems serving 4,100 or fewer 
people) and changes in number of corrective actions (for systems 
serving greater than 4,100 people) as measures of reduced risk. As 
discussed previously, the assessments and corrective actions required 
under the RTCR will help lead to a decrease in total coliform and E. 
coli occurrence in drinking water. Since fecal contamination can 
contain waterborne pathogens including bacteria, viruses, and parasitic 
protozoa, in general, a reduction in fecal contamination should also 
reduce the potential risk from these other contaminants and the 
associated primary and secondary endemic disease burden, both acute and 
chronic.
    b. Other nonquantifiable benefits. Other nonquantified benefits may 
include those associated with increased knowledge regarding system 
operation, accelerated maintenance and repair, avoided costs of 
outbreaks, and reductions in averting behavior.
    By requiring PWSs to conduct assessments that meet minimum elements 
focused on identifying sanitary defects in response to triggers for 
total coliform- or E. coli-positive samples, the proposed RTCR 
increases the likelihood that PWS operators, in particular those of 
systems triggered to conduct assessments and corrective action, will 
develop further understanding of system operations and improve and 
practice preventive maintenance compared to the current TCR, which does 
not require PWSs to perform assessments and corrective action.
    Another non-quantified benefit is that systems may choose 
corrective actions that also address other drinking water contaminants. 
For example, correcting for a pathway of potential contamination into 
the distribution system can possibly also mitigate a variety of other 
potential contaminants. Due to the lack of data available on the effect 
of corrective action on contamination entering through distribution 
system pathways, EPA has not quantified such potential benefits.
    Some systems may see additional nonquantified benefits associated 
with the acceleration of their capital replacement fund investments in 
response to early identification of impending problems with large 
capital components. Although such capital investment will eventually 
occur anyway, earlier investment may ensure that problems are addressed 
in a preventive manner and may preclude some decrease in protection 
that might have occurred otherwise. At the very least, the increased 
operator awareness is expected to reduce the occurrence of unplanned 
capital expenditures in any given year. However, because of the 
difficulty of projecting when capital replacements would occur, EPA has 
not costed this acceleration of capital replacement, so there would 
also be a nonquantified cost of making such investments sooner.
    Another major non-health benefit is the avoided costs associated 
with outbreak response. Outbreaks can be very costly for both the PWS 
and the community in which they occur. Avoided outbreak response costs 
include such costs as issuing public health warnings, boiling drinking 
water and providing alternative supplies, remediation and repair, and 
testing and laboratory costs. Reduced total coliform occurrence 
resulting from the proposed RTCR may also lead to a reduction of costs 
associated with boil-water orders, which some States require following 
non-acute violations under the current TCR. Taken together, these 
expenses can be quite significant. For example, an analysis of the 
economic impacts of a waterborne disease outbreak in Walkerton, Ontario 
(population 5,000) estimated the economic impact, excluding medically 
related costs, to be over $45.9 million in 2007 Canadian dollars 
(approximately 42.8 million 2007 US dollars) (Livernois 2002). The 
author of the study believed that this was a conservative estimate.
    In addition, the proposed RTCR may also reduce uncertainty 
regarding drinking water safety, which may lead to reduced costs for 
averting behaviors. Averting behaviors include the use of bottled water 
and point-of-use devices. This benefit also includes the reductions in 
time spent on averting behavior such as the time spent obtaining 
alternative water supplies.

F. Anticipated Costs of the Proposed RTCR

    To understand the net impacts of the proposed RTCR on public water 
systems and States in terms of costs, EPA first used available data, 
information, and best professional judgment to characterize how PWSs 
and States are currently implementing the current TCR, and to estimate 
cost relative to a baseline of no RTCR. Then, EPA considered the net 
change in costs that results from implementing the AIP or Alternative 
options as compared to the costs of continuing with the current TCR. 
The objective was to present the net change in costs resulting from 
revisions to the current TCR rather than absolute totals. More detailed 
information on cost estimates is provided in the sections that follow 
and a complete discussion can be found in chapter 7 of the Proposed 
RTCR EA (USEPA 2010a). A detailed discussion of the proposed revisions 
is located in section III of this preamble.
1. Total Annualized Present Value Costs
    To compare cost of compliance activities for the three regulatory 
scenarios, the year or years in which all costs are expended are 
determined and the costs are then calculated as a net present value. 
For the purposes of this EA, one-time and yearly costs were projected 
over a 25-year time period to allow comparison with other drinking 
water regulations using the same analysis period. For this analysis, 
the net present values of costs in 2007 dollars are calculated using 
discount rates of three percent and seven percent. These present value 
costs are then annualized over the 25-year period using the two 
discount rates.
    Exhibit VI-15 summarizes the comparison of total and net change in 
annualized present value of the AIP and Alternative options relative to 
the current TCR baseline. A continuation of the current TCR will result 
in no net change in costs. The net change in mean annualized present 
value national costs of the AIP option is estimated to be

[[Page 40976]]

approximately $14 million (M) using either a three percent or seven 
percent discount rate. The net change in mean annualized present value 
national costs for the Alternative option are estimated to be 
approximately $27M using a three percent discount rate and $30M using a 
seven percent discount rate.
    Under the AIP option, public water systems are estimated to incur 
greater than 90 percent of the proposed revised rule's net annualized 
present value costs. States are expected to incur the remaining costs.
    Exhibit VI-16 presents the comparison of total and net change in 
annualized present value costs by rule component. The table shows that 
routine monitoring and corrective action costs are the most significant 
contributors to the net increase in costs for PWSs under both the AIP 
and Alternative options. For States, revising sampling plans contribute 
most to the cost increase. For both PWSs and States, a net decrease in 
costs associated with PN requirements helps to offset the total net 
cost increase.
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2. PWS Costs
    Like the current TCR, the proposed RTCR applies to all PWSs. 
Exhibit VI-17 presents the total and net change in annualized costs to 
PWSs by size and type for the three regulatory options. No net change 
in costs will result from a continuation of the current TCR. Among PWSs 
serving 4,100 or fewer people, looking at the three percent discount 
rate, the largest increase in aggregate net costs is incurred by the 
TNCWSs serving 100 or fewer people under either the AIP ($5.1M) or 
Alternative option ($13.4M) because of the large number of systems. On 
a per system basis, this translates to a net annualized present value 
increase of approximately $83 per system under the AIP and $217 per 
system under the Alternative option for the TNCWSs serving 100 or fewer 
people. As described in section VII.C of this preamble, none of the 
small TNCWSs are estimated to have costs that are greater than or equal 
to three percent of their revenue.
    The total net change in national annualized present value costs for 
all PWSs serving greater than 4,100 people (approximately $6M using 
three percent discount rate) is the same under the AIP and Alternative 
option. This is expected because the provisions for PWSs serving 
greater than 4,100 are the same under either option. Monitoring 
requirements for PWSs serving greater than 4,100 people remain 
essentially unchanged under either the AIP or Alternative option. The 
observed overall net increase in costs for PWSs serving greater than 
4,100 people is driven primarily by the requirements to conduct 
assessments and to correct any sanitary defects that are found.
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    a. Rule implementation and annual administration. Under the AIP and 
Alternative options, all PWSs subject to the proposed RTCR incur one-
time costs that include time for staff to read the RTCR, become 
familiar with its provisions, and to train employees on rule 
requirements. No additional implementation burden or costs will be 
incurred by PWSs if the current TCR option is maintained. Under the AIP 
and Alternative options, all PWSs subject to the proposed RTCR perform 
additional or transitional implementation activities. Based on previous 
experience with rule implementation, EPA estimated that PWSs require a 
total of four hours to

[[Page 40979]]

read and understand the rule, and a total of eight hours to plan and 
assign appropriate personnel and resources to carry out rule 
activities.
    b. Revising sampling plans. Under the AIP and Alternative options, 
all PWSs subject to the proposed RTCR incur one-time costs to revise 
existing sampling plans to identify sampling locations and collection 
schedules that are representative of water throughout the distribution 
system. Under the TCR, no additional burden or costs are expected to be 
incurred by PWSs to revise sampling plans, as these PWSs are already 
collecting total coliform samples in accordance with a written sampling 
plan. Based on previous experience, EPA estimated that PWSs require 2-8 
hours to revise their sampling plan, depending on PWS size.
    c. Monitoring. Monitoring costs for PWSs are calculated by 
multiplying the total numbers of routine, additional routine, and 
repeat samples required under the current TCR, AIP, and Alternative 
options by the monitoring costs per sample. Under the AIP, the 
increased stringency to qualify for reduced monitoring results in more 
routine samples being taken over time (fewer PWSs are on reduced 
monitoring). For the Alternative option, this effect is combined with 
the requirement that all PWSs start the implementation period on 
monthly monitoring. The Alternative option also prohibits annual 
monitoring, resulting in a greater increase in the number of routine 
samples compared to the AIP option. The resulting increases in costs 
due to increased monitoring are reflected in the routine monitoring 
costs.
    The overall reductions in the numbers of additional routine samples 
required under the AIP and Alternative option result in reduced costs. 
Under the AIP and Alternative options, additional routine monitoring is 
no longer required for systems that monitor at least monthly, and when 
additional routine monitoring is required, the number of samples 
required is reduced from five to three. Cost reductions are greater 
under the Alternative option than under the AIP because under the 
Alternative option all PWSs start on monthly monitoring and are not 
required to take additional routine samples during that period.
    Under the current TCR, PWSs serving 1,000 or fewer people take four 
repeat samples at and within five service connections upstream and 
downstream of the initial total coliform positive occurrence location 
over the course of 24 hours following the event. Under the AIP and 
Alternative options, they will only need to take three repeat samples, 
and they have greater flexibility about where to take them, consistent 
with the system sample siting plan that is developed in accordance with 
RTCR requirements and subject to review and revision by the State. The 
number of repeat samples required for PWSs serving more than 1,000 
people is the same under the current TCR and the AIP and Alternative 
options, although they too have greater flexibility in sample location.
    Exhibit VI-18 summarizes the cumulative number of samples taken by 
PWS size and category for routine, additional, and repeat monitoring 
under the TCR, AIP, and Alternative option over the entire 25-year 
period of analysis. Under the current TCR option, approximately 82.1 
million samples are taken over the 25-year period of analysis compared 
to approximately 82.2 million samples under the AIP option and 
approximately 87.9 million samples under the Alternative option (less 
than 10 percent more than current TCR option). Appendix A of the 
Proposed RTCR EA (USEPA 2010a) presents additional information on the 
number of samples taken each individual year during the analysis 
period.
    The annualized net present value total and net change cost 
estimates for PWSs and States to perform monitoring under the TCR, AIP, 
and Alternative options are presented in Exhibit VI-19.
BILLING CODE 6560-50-P

[[Page 40980]]

[GRAPHIC] [TIFF OMITTED] TP14JY10.016

[[Page 40981]]

[GRAPHIC] [TIFF OMITTED] TP14JY10.017

BILLING CODE 6560-50-C
    The overall estimated increase in monitoring costs seen under the 
AIP is driven by increases in routine monitoring due to stricter 
requirements to qualify for reduced monitoring. However, this is mostly 
offset by reductions in additional routine and repeat monitoring 
required under the revised regulations. For the Alternative option, the 
requirement for all PWSs to sample on a monthly basis at the beginning 
of rule implementation results in a much larger cost differential that 
is only partially offset by reduced costs due to reductions in 
additional routine monitoring requirements.
    d. Annual site visits. Under the AIP, any PWS on an annual 
monitoring schedule is required to also have an annual site visit 
conducted by the State or State-designated third party. A voluntary 
Level 2 site assessment can also satisfy the annual site visit 
requirement. For years in which the State performs a sanitary survey 
(at least every five years for NCWSs and three years for CWSs), a 
sanitary survey performed during the same year can also be used to 
satisfy this requirement. EPA uses the same assumptions to estimate 
costs associated with site visits for both the AIP and Alternative 
options.
    e. Assessments. Annualized cost estimates for Level 1 and Level 2 
assessments under the TCR, AIP, and Alternative options are calculated 
in the Proposed RTCR EA (USEPA 2010a) by multiplying the number of 
assessments estimated by the predictive modeling (summarized in Exhibit 
7.13 of the EA) by the unit costs (summarized in Exhibits 7-11 and 7-12 
of the EA). Appendix A of the Proposed RTCR EA (USEPA 2010a) provides a 
detailed breakout of the number of Level 1 and Level 2 assessments 
estimated by the occurrence model. Annualized cost estimates are 
presented in Exhibit VI-20 of this preamble.

[[Page 40982]]

[GRAPHIC] [TIFF OMITTED] TP14JY10.018

    Under the proposed RTCR, all PWSs are required to conduct 
assessments of their systems when they exceed Level 1 or Level 2 
treatment technique triggers. While PWSs are not required to conduct 
assessments under the current TCR, some PWSs do currently engage in 
assessment activity (which may or may not meet the proposed RTCR 
criteria) following non-acute and acute MCL violations. EPA estimates 
both the costs to PWSs to conduct assessments under the proposed RTCR 
as well as the level of effort that PWSs already put towards assessment 
activities under the current TCR. These estimates are based on the work 
of the stakeholders in the Technical Work Group (TWG) during the 
proceedings of the TCRDSAC. These estimates allowed EPA to determine 
the average net costs to conduct assessments under the proposed RTCR. 
EPA assumes that the numbers of non-acute and acute MCL violations 
would remain steady under a continuation of the current TCR (based on 
review of SDWIS/FED violation data). Under the proposed RTCR, EPA 
assumes that the numbers of assessments decreases from the steady state 
level seen under the current TCR over time to a new steady state level 
as a function of reduced fecal indicator occurrence associated with the 
effects of requiring assessments and corrective action.
    The overall number of assessments is larger under the Alternative 
option compared to the AIP option. This is a result of the initial 
monthly monitoring requirements for all PWSs under this analysis. The 
modeling results indicate that a greater number of samples early in the 
implementation period results in more positive samples and associated 
assessments despite the predicted long term reductions in occurrence as 
informed by the assumptions. This increase in total assessments 
performed, combined with the higher unit cost of performing assessments 
compared to existing practices under the TCR, results in a higher net 
cost increase for the Alternative option than under the AIP. The total 
net change in cost for the Alternative option is estimated to be 
positive, and nearly twice as high as under the AIP option. See Exhibit 
7.15 of the Proposed RTCR EA (USEPA 2010a).
    f. Corrective actions. Under the AIP and Alternative options, all 
PWSs are required to correct sanitary defects found through the 
performance of Level 1 or Level 2 assessments. For modeling purposes, 
EPA estimated the net change in the number of corrective actions 
performed under the AIP and Alternative options. EPA assumed that any 
corrective actions based on a positive source water sample are 
accounted for under the GWR and not under the proposed RTCR. Based on 
discussions with State representatives, EPA assumed that additional 
corrective actions are performed for only 10 percent of the assessments 
undertaken as a result of the proposed RTCR representing the net 
increase over the current TCR.
    To estimate the costs incurred for the correction of sanitary 
defects, EPA assumed the percent distribution of PWSs that perform 
different types of corrective actions as presented in the compliance 
forecast shown in Exhibit VI-21 based on best professional judgment. 
The compliance forecast presented in this section was informed by 
discussions of the TCRDSAC Technical Work Group and focuses on broad 
categories of types of corrective actions anticipated. EPA used best 
professional judgment to make simplifying assumptions on the 
distribution of these categories that are implemented by different 
systems based on size and type of system. For each of the categories 
listed, a PWS is assumed to take a specific action that falls under 
that general category. Detailed compliance forecasts showing the 
specific corrective actions used in the cost analysis are provided in 
Appendix D of the Proposed RTCR EA (USEPA 2010a), along with summary 
tables of the unit costs used in the analysis. Each corrective action 
in the detailed compliance forecast is also assigned a representative 
unit cost. Detailed descriptions of the derivation of unit costs are 
provided in Exhibits 5-1

[[Page 40983]]

through 5-47 of the Technology and Cost Document for the Proposed 
Revised Total Coliform Rule (USEPA 2010b).
[GRAPHIC] [TIFF OMITTED] TP14JY10.019

    As shown in the compliance forecast in Exhibit VI-21, EPA estimated 
that corrective actions found through Level 1 assessments result in 
corrective actions that focus more on transient solutions or training 
(columns A and B) than on permanent fixes to the PWS. However, in the 
case of flushing, EPA assumed that in a majority of instances, PWSs 
implement a regular flushing program as opposed to a single flushing, 
based on EPA and stakeholder best professional judgment. Level 1 
assessments generally are less involved than Level 2 assessments and 
may result in finding less complex problems.
    Corrective actions taken as a result of Level 2 assessments are 
expected to find a higher proportion of structural/technical issues 
(columns C-K) resulting in material fixes to the PWSs and distribution 
system. Consistent with the discussions of the TCRDSAC regarding major 
structural fixes or replacements, EPA did not include these major costs 
in the analysis. Distribution system appurtenances such as storage 
tanks generally have a useful life that is accounted for in water 
system capital planning and the assessments conducted in response to 
RTCR triggers could identify when that useful life has ended but are 
not solely responsible for the need to correct the defect. In addition, 
EPA ran two sensitivity analyses to assess the potential impacts of 
different distributions within the compliance forecast. Results of the 
sensitivity analyses are presented in Exhibit 7-24 of the Proposed RTCR 
EA (USEPA 2010a), which indicates that the low bound estimates of 
annualized net change in costs at three percent discount rate are 
approximately $3M for the AIP option and $15M for the Alternative 
option, and the high bound estimates are approximately $25M for the AIP 
option and $40M for the Alternative option. Varying the assumptions 
about the percentage of corrective actions identified and the 
effectiveness of those actions had less than a linear effect on 
outcomes, and the AIP option continues to be less costly than the 
Alternative option under all scenarios modeled.
    As indicated in the more detailed analysis presented in chapter 7 
of the Proposed RTCR EA (USEPA 2010a), PWSs also incur reporting and 
recordkeeping burden to notify the State upon completion of each 
corrective action. PWSs may also consult with the State or with outside 
parties to determine the appropriate corrective action to be 
implemented.
    Annualized cost estimates for PWSs to perform corrective actions 
are estimated by multiplying the number of Level 1 and Level 2 
corrective actions estimated by the predictive model, (i.e., 10 percent 
of Level 1 and Level 2 assessments) by the percentages in the 
compliance forecast and unit costs of corrective actions and associated 
reporting and recordkeeping. Exhibit 7.13 of the proposed RTCR EA 
(USEPA 2010a) presents the estimated totals of non-acute and acute MCL 
violations (current TCR) and Level 1 and Level 2 assessments (AIP and 
Alternative options). The model predicts a total of approximately 
109,000 single non-acute MCL violations, 58,000 cases of a second non-
acute MCL violation, and 16,000 acute MCL violations for the current 
TCR, under which some PWSs currently engage in assessment activity 
which may or may not meet the proposed RTCR criteria (see section 7.4.5 
of the proposed RTCR EA (USEPA 2010a) for details). For the AIP option, 
the model predicts approximately 104,000 Level 1 assessments and 52,000 
Level 2 assessments. For the Alternative option, the model predicts 
approximately 115,000 Level 1 assessments and 78,000 Level 2 
assessments. The total and net change costs of corrective actions are 
shown in Exhibit VI-22.

[[Page 40984]]

   Exhibit VI-22--Annualized PWS Cost Estimates for Corrective Actions
                Based on Level 1 and Level 2 Assessments
                           [$Millions, 2007$]
------------------------------------------------------------------------
                                            3% Discount     7% Discount
                                               rate            rate
------------------------------------------------------------------------
                                            Corrective Actions based on
                                                Level 1 Assessments
                                         -------------------------------
TCR--Total..............................  ..............  ..............
AIP--Total..............................           $9.17           $7.77
AIP--Net Change.........................            9.17            7.77
Alternative option--Total...............            9.39            8.01
Alternative option--Net Change..........            9.39            8.01
                                         -------------------------------
                                            Corrective Actions based on
                                                Level 2 Assessments
                                         -------------------------------
TCR--Total..............................  ..............  ..............
AIP--Total..............................           $2.72           $2.41
AIP--Net Change.........................            2.72            2.41
Alternative option--Total...............            3.53            3.36
Alternative option--Net Change..........            3.53            3.36
------------------------------------------------------------------------
Note: Detail may not add due to independent rounding.
Source: Proposed RTCR cost model, described in chapter 7 of the Proposed
  RTCR EA (USEPA 2010a).

    The differences in the net change in corrective action costs 
between the AIP and Alternative option are a function of the different 
number of assessments estimated to be performed in the predictive 
model.
    g. Public notification. Estimates of PWS unit costs for PN are 
derived by multiplying PWS labor rates from section 7.2.1 of the 
Proposed RTCR EA (USEPA 2010a) and burden hour estimates derived from 
the Draft Information Collection Request for the Public Water System 
Supervision Program (USEPA 2008c). PWS PN unit cost estimates are 
presented in Exhibit 7.19 of that document.
    Total and net change in annualized net present value costs for PN 
are estimated by multiplying the model estimates of PWSs with acute 
(Tier 1 public notification) and non-acute (Tier 2 public notification) 
violations by the PWS unit costs for performing PN activities. The 
proposed RTCR cost model assumed that all violations are addressed 
following initial PN, and no burden is incurred by PWSs for repeat 
notification. Annualized total and net cost estimates for PWSs and 
States to perform public notification under the TCR, AIP, and 
Alternative options are presented in Exhibit VI-23.

    Exhibit VI-23--Annualized National PWS Cost Estimates for Public
                              Notification
                           [$Millions, 2007$]
------------------------------------------------------------------------
                                            3% Discount     7% Discount
                                               rate            rate
------------------------------------------------------------------------
TCR--Total..............................           $3.75           $3.60
AIP--Total..............................           $0.26           $0.26
AIP--Net Change.........................         $(3.49)         $(3.35)
AIP--Percent Change.....................            -93%            -93%
Alternative Option--Total...............           $0.34           $0.35
Alternative Option--Net Change..........         $(3.41)         $(3.26)
Alternative Option--Percent Change......            -91%            -90%
------------------------------------------------------------------------
Note: Detail may not add due to independent rounding.
Source: Proposed RTCR cost model, described in chapter 7 of the Proposed
  RTCR EA (USEPA 2010a).

    A significant reduction in costs is estimated due to the 
elimination of Tier 2 public notification for non-acute/monthly MCL 
violations under both the AIP and Alternative options.
3. State Costs
    EPA estimated that all States nationally together incur a net 
increase in national annualized present value costs under the AIP 
option of $0.1M (at three percent discount rate) and $0.4M (at seven 
percent discount rate) and under the Alternative option of $0.3M (at 
three percent discount rate) and $0.6M (at seven percent discount 
rate). State costs include implementing and administering the rule, 
revising sampling plans, reviewing sampling results, conducting annual 
site visits, reviewing completed assessment forms, tracking corrective 
actions, and public notifications. The following sections summarize the 
key assumptions that EPA made to estimate the costs of the proposed 
RTCR. Chapter 7 of the Proposed RTCR EA (USEPA 2010a) provides a 
description of the analysis.
    a. Rule implementation and annual administration. States incur 
administrative costs to implement the proposed RTCR. These 
implementation costs are not directly required by specific provisions 
of the proposed RTCR alternatives, but are necessary for States to 
ensure the provisions of the proposed RTCR are properly carried out. 
States need to allocate time for their staff to establish and maintain 
the programs necessary to comply with the proposed RTCR, including 
developing and adopting State regulations and

[[Page 40985]]

modifying data management systems to track new required PWS reports to 
the States. Time requirements for a variety of State agency activities 
and responses are estimated in this EA. Exhibit 7.4 of the Proposed 
RTCR EA (USEPA 2010a) lists the activities required to revise the 
program following promulgation of the proposed RTCR along with their 
respective costs and burden including, for example, the net change in 
State burden associated with tracking the monitoring frequencies of 
PWSs (captured under ``modify data management systems''). EPA estimated 
a net increase in national annualized cost estimates incurred by States 
for rule implementation of $0.18M (three percent discount rate) and 
$0.26M (seven percent discount rate) under either the AIP or the 
Alternative option. Because time requirements for implementation and 
annual administration activities vary among State agencies, EPA 
recognizes that the unit costs used to develop national estimates may 
be an over- or under-estimate for some States.
    b. Revising sampling plans. Under the AIP and Alternative options, 
States are expected to incur one-time costs to review sampling plans 
and recommend any revisions to PWSs. Under the TCR option, no 
additional burden or costs are incurred by States to review sampling 
plans, as these PWSs' sampling plans have already been reviewed and 
approved. State costs are based on the number of PWSs submitting 
revised sampling plans to PWSs each year. Based on previous experience, 
EPA estimated that States require one to four hours to review revised 
sampling plans and provide any necessary revisions to PWSs, depending 
on PWS size. EPA estimated a net increase in national annualized cost 
estimates incurred by States for revising sampling plans of $0.42M 
(three percent discount rate) and $0.59M (seven percent discount rate) 
under either the AIP or the Alternative option.
    c. Monitoring. EPA assumed that States incur a monthly 15-minute 
burden to review each PWS's sample results under the current TCR. This 
estimate reflects the method used to calculate reporting and 
recordkeeping burden under the current TCR in the Draft Information 
Collection Request for the Microbial Rules (USEPA 2008a). Because the 
existing method calculates cost on a per PWS basis and the total number 
of PWSs is the same for cost modeling under the TCR and both proposed 
RTCR options, the net change in costs for reviewing monitoring results 
is assumed to be zero for the AIP and Alternative options. Specific 
actions by States related to positive samples are accounted for under 
the actions required in response to those samples.
    d. Annual site visits. Under the AIP option, any PWS on an annual 
monitoring schedule is required to also have an annual site visit 
conducted by the State or State-designated third party. A voluntary 
Level 2 site assessment can also satisfy the annual site visit 
requirement. In many cases a sanitary survey performed during the same 
year can also be used to satisfy this requirement. Although similar 
site visits are not currently required under the current TCR, 
discussions with States during the TCRDSAC proceedings revealed that 
some do, in fact, conduct such site visits for PWSs on annual 
monitoring schedules. Because of the high cost for an annual site visit 
by a State, for this analysis EPA assumed that no States choose to 
conduct annual site visits unless they already do so under the current 
TCR. Therefore, for overall costing purposes, no net change in State or 
PWS costs are assumed for annual monitoring site visits under the AIP 
option or Alternative option.
    e. Assessments. States incur burden to review completed assessment 
forms required to be filed by PWSs under the AIP and Alternative 
options. Although specific forms are not required under the current 
TCR, EPA assumes that PWSs engage in some form of consultation with the 
State. For costing purposes, EPA assumes that the level of effort 
required for such consultations under the current TCR is the same as 
that which would be required to review assessment forms under the AIP 
and Alternative options. State costs are based on the number of PWSs 
submitting assessment reports. EPA estimated that State burden to 
review PWS assessment forms ranges from one to eight hours depending on 
PWS size and type, as well as the level of the assessment. This burden 
includes any time required to consult with the PWS about the assessment 
report.
    Although some States may choose to conduct assessments for their 
PWSs, EPA does not quantify these costs. The costs are attributed to 
PWSs that are responsible for insuring that assessments are done.
    The reduction in the number of assessments under the AIP option 
compared to the current TCR (as explained in chapter 7 of the Proposed 
RTCR EA (USEPA 2010a), based on discussions with the technical 
workgroup supporting the advisory committee, EPA assumes a certain 
level of assessment activity already occurs under the current TCR) is 
estimated to translate directly to a small national cost savings 
($0.08M at either three or seven percent discount rate) while the 
increase in the number of assessments under the Alternative option is 
estimated to translate directly to a national cost increase ($0.03M at 
three percent discount rate and $0.07M at seven percent discount rate). 
Under the AIP, the overall number of assessments decreases as a 
function of reduced occurrence over time. The overall number of 
assessments is higher under the Alternative option as a result of the 
initial monthly monitoring requirements for all PWSs.
    f. Corrective actions. For each corrective action performed under 
AIP and Alternative option, States incur recordkeeping and reporting 
burden to review and coordinate with PWSs. This includes burden 
incurred from any optional consultations States may conduct with PWSs 
or outside parties to determine the appropriate corrective action to be 
implemented. The number of corrective actions under either the AIP or 
Alternative option is estimated to translate to a national net 
annualized cost increase to States of $0.01M at either three or seven 
percent discount rate
    g. Public notification. Under the TCR, AIP, and Alternative 
options, States incur recordkeeping and reporting burden to provide 
consultation, review the public notification certification, and file 
the report of the violation. A significant reduction in costs is 
estimated due to the elimination of Tier 2 public notification for non-
acute MCL violations under the AIP and Alternative options. Because 
State costs are calculated on a per-violation basis, State costs 
decline. Under the Alternative option, some of the decrease in cost is 
offset by additional Tier 1 public notification from the increase in 
the number of E. coli MCL violations detected. Burden hour estimate for 
State unit PN costs are derived from the Draft Information Collection 
Request for the Public Water System Supervision Program (USEPA 2008b). 
Exhibit VI-24 summarizes annualized State cost estimates for public 
notification.

[[Page 40986]]

 Exhibit VI-24--Annualized State Cost Estimates for Public Notification
                           [$Millions, 2007$]
------------------------------------------------------------------------
                                            3% Discount     7% Discount
                                               rate            rate
------------------------------------------------------------------------
TCR--Total..............................           $0.44           $0.42
AIP--Total..............................           $0.06           $0.06
AIP--Net Change.........................         $(0.38)         $(0.36)
AIP--Percent Change.....................            -86%            -86%
Alternative Option--Total...............           $0.08           $0.08
Alternative Option--Net Change..........         $(0.36)         $(0.34)
Alternative Option--Percent Change......            -82%            -80%
------------------------------------------------------------------------
Note: Detail may not add due to independent rounding.
Source: Proposed RTCR cost model, described in chapter 7 of the Proposed
  RTCR EA (USEPA 2010a).

4. Nonquantifiable Costs
    EPA believes that all of the rule elements that are the major 
drivers of the net change in costs from the current TCR have been 
quantified to the greatest degree possible. However, cost reductions 
related to fewer monitoring and reporting violations are not 
specifically accounted for in the cost analysis, and their exclusion 
from consideration may result in an overestimate of net change in cost 
between the TCR option and the AIP option or Alternative option.
    In addition under the TCR, AIP, and Alternative options, Tier 3 
public notification for monitoring and reporting violations are assumed 
to be reported once per year as part of the Consumer Confidence Reports 
(CCRs). Because of the use of the CCR to communicate Tier 3 public 
notification on a yearly basis, no cost differential between the 
current TCR and the AIP and Alternative options is estimated in the 
cost model. However, the advisory committee concluded that significant 
reductions in monitoring and reporting violations may be realized 
through the revised regulatory framework of the proposed RTCR, which 
includes new consequences for failing to comply with monitoring 
provisions such as the requirement to conduct an assessment or 
ineligibility for reduced monitoring. These possible reductions have 
not been quantified. System resources used to process monitoring 
violation notices for the CCR and respond to customer inquiries about 
the notices, as well as State resources to remind systems to take 
samples, may be reduced if significant reductions are realized. 
Exclusion of this potential cost savings may lead to an underestimate 
of the PN cost savings under both the AIP and Alternative option. Such 
cost savings to States may be significant given the high occurrence of 
monitoring and reporting violations under the current TCR.
    Additionally, as an underlying assumption to the costing 
methodology, EPA assumed that all PWSs subject to the proposed RTCR 
requirements are already complying with the current TCR. There may be 
some PWSs that are not in full compliance with the current TCR, and if 
so, additional costs and benefits are incurred.

G. Potential Impact of the Proposed RTCR on Households

    The household cost analysis considers the potential increase in a 
household's annual water bill if a CWS passed the entire cost increase 
resulting from the proposed rule on to their customers. This analysis 
is a tool to gauge potential impacts and should not be construed as a 
precise estimate of potential changes to household water bills. State 
costs and costs to TNCWSs and NTNCWSs are not included in this analysis 
since their costs are not typically passed through directly to 
households. Exhibit VI-25 presents the mean expected increases in 
annual household costs for all CWSs, including those systems that do 
not have to take corrective action. Exhibit VI-25 also presents the 
same information for CWSs that must take corrective action. Household 
costs tend to decrease as system size increases, due mainly to the 
economies of scale for the corrective actions.
    The first category in Exhibit VI-25 presents net costs per 
household under the AIP and Alternative options for all rule components 
spread across all CWSs. In this scenario, comparison to the current TCR 
shows a cost savings for some households. For those households that are 
expected to see a cost increase, the average annual water bill is 
expected to increase by less than five cents on average.
    While the average increase in annual household water bills to 
implement the AIP option is less than a dollar, customers served by a 
small CWS that have to take corrective actions as a result of the 
proposed rule incur slightly larger increases in their water bills. The 
subsequent categories of the exhibit present net costs per household 
for three different subsets of CWSs: (1) CWSs that perform assessments 
but no corrective actions, (2) CWSs that perform corrective actions, 
and (3) CWSs that do not perform assessments or corrective actions. 
Approximately 77 percent of households are served by CWSs that perform 
assessments but do not perform corrective actions over the 25-year 
period of analysis (because no sanitary defects are found). These 
households experience a slight cost savings on an annual basis. The 
nine percent of households belonging to CWSs that perform corrective 
actions over the 25-year period of analysis experience an increase in 
annual net household costs of less than $0.70 on average for CWSs 
serving greater than 4,100 people to approximately $4 on average for 
CWSs serving 4,100 or fewer people on an annual basis. EPA estimated 
that 14 percent of households are served by CWSs that do not perform 
assessments or corrective actions over the 25-year period of analysis. 
This group of households served by small systems (4,100 or fewer 
people) experiences a slight cost change on an annual basis, comparable 
to those performing assessments but no corrective actions. Overall, the 
main driver of additional household costs under the proposed RTCR is 
corrective actions.

[[Page 40987]]

             Exhibit VI-25--Summary of Net Annual Per-Household Costs for the Proposed RTCR (2007$)
----------------------------------------------------------------------------------------------------------------
                                                   3% Discount rate                    7% Discount rate
                                         -----------------------------------------------------------------------
        Population served by PWS           AIP option net      Alternative     AIP option net      Alternative
                                              cost per       option net cost      cost per       option net cost
                                              household       per household       household       per household
----------------------------------------------------------------------------------------------------------------
                                       All Community Water Systems (CWSs)
----------------------------------------------------------------------------------------------------------------
<= 4,100................................             $0.07             $0.09             $0.10             $0.12
> 4,100.................................              0.05              0.05              0.04              0.04
                                         -----------------------------------------------------------------------
    Total...............................              0.05              0.06              0.05              0.05
----------------------------------------------------------------------------------------------------------------
        Community Water Systems (CWSs) performing Level 1/Level 2 Assessments (and no Corrective Actions)
----------------------------------------------------------------------------------------------------------------
<= 4,100................................            (0.22)            (0.19)            (0.16)            (0.13)
> 4,100.................................            (0.02)            (0.01)            (0.01)            (0.01)
                                         -----------------------------------------------------------------------
    Total...............................            (0.02)            (0.01)            (0.01)            (0.01)
----------------------------------------------------------------------------------------------------------------
                          Community Water Systems (CWSs) performing Corrective Actions
----------------------------------------------------------------------------------------------------------------
<= 4,100................................              4.11              4.14              3.63              3.68
> 4,100.................................              0.65              0.65              0.54              0.54
                                         -----------------------------------------------------------------------
    Total...............................              0.78              0.78              0.66              0.66
----------------------------------------------------------------------------------------------------------------
        Community Water Systems (CWSs) not performing Level 1/Level 2 Assessments, or Corrective Actions
----------------------------------------------------------------------------------------------------------------
<= 4,100................................              0.00              0.02              0.04              0.06
> 4,100.................................              0.00              0.00              0.00              0.00
                                         -----------------------------------------------------------------------
    Total...............................              0.00              0.01              0.01              0.02
----------------------------------------------------------------------------------------------------------------
Source: Proposed RTCR EA (USEPA 2010a).

H. Incremental Costs and Benefits

    The proposed RTCR regulatory options achieve increasing levels of 
benefits at increasing levels of costs. The regulatory options for this 
proposed rule, in order of increasing costs and benefits (Option 1 
lowest, and option 3 highest) are as follows:
     Option 1: Current TCR option
     Option 2: AIP option
     Option 3: Alternative option

More information about the options is provided in the Proposed RTCR EA 
(USEPA 2010a).
    Incremental costs and benefits are those that are incurred or 
realized to reduce potential illnesses and deaths from one alternative 
to the next more stringent alternative. Estimates of incremental costs 
and benefits are useful when considering the economic efficiency of 
different regulatory alternatives considered by EPA. One goal of an 
incremental analysis is to identify the regulatory alternatives where 
net social benefits are maximized. However, incremental net benefits 
analysis is not possible when benefits are not monetized as in the case 
with the proposed RTCR.
    However, incremental analysis can still provide information on 
relative cost-effectiveness of different regulatory options. For the 
proposed RTCR, only costs were monetized. While benefits were not 
quantified, an indirect proxy for benefits was. To compare the 
additional net cost increases and associated incremental benefits of 
the AIP and the Alternative options, benefits are presented in terms of 
corrective actions performed since performance of corrective actions is 
expected to have an impact that is most directly translatable into 
potential health benefits.
    Exhibit VI-26 shows the incremental cost of the AIP over the 
current TCR and the Alternative option over the AIP option for costs 
annualized using three percent and seven percent discount rates. The 
incremental benefits of the Alternative option in terms of incremental 
corrective actions performed (114 at three percent and 135 and seven 
percent discount rates) are fewer than for the AIP (202 at three 
percent and 189 at seven percent discount rates), despite the increased 
costs. The non-monetized corrective action endpoints are discounted in 
order to make them comparable to monetized endpoints. The relationship 
between the incremental costs and benefits is examined further with 
respect to cost effectiveness in section VI.M of this preamble.

 Exhibit VI-26--Incremental Net Change in Annualized Present Value Costs ($Millions, 2007$) and Benefits (Number
                                             of Corrective Actions)
----------------------------------------------------------------------------------------------------------------
                                                               Costs                  Benefits (L2 corrective
                                                 --------------------------------            actions)
                Regulatory option                                                -------------------------------
                                                        3%              7%              3%              7%
----------------------------------------------------------------------------------------------------------------
Current TCR.....................................          $186.1          $178.4   \3\ No change   \3\ No change
AIP.............................................           199.8           192.5             202             189
Incremental AIP \1\.............................            13.7            13.7             202             189

[[Page 40988]]

Alternative.....................................           213.3           208.5             317             323
Incremental Alternative \2\.....................            13.5            16.0             114             135
----------------------------------------------------------------------------------------------------------------
\1\ Represents the incremental net change of the AIP option over the current TCR option.
\2\ Represents the incremental net change of the Alternative option over the AIP option. Add incremental net
  change for Alternative option to incremental net change for AIP option to calculate the total net change of
  the Alternative option over the current TCR option.
Note: The RTCR occurrence model yields the number of corrective actions that are expected to be implemented in
  addition to (net of) those already implemented under the current TCR. The model does not incorporate an
  estimate of the number of corrective actions implemented per year under the current TCR and does not yield a
  total for the AIP and Alternative option that includes the current TCR corrective actions. Benefits shown
  include corrective actions based on L2 assessments. Detailed benefits and cost information is provided in
  Appendices A and C, respectively, of the Proposed RTCR EA (USEPA 2010a).
\3\ As explained in section VI.F.2.f of this preamble, for modeling purposes, EPA estimates the net change only
  in the number of corrective actions performed under the AIP and Alternative options compared to the current
  TCR and thus did not quantify the (non-zero) baseline number of corrective actions performed under the Current
  TCR.

I. Benefits From Simultaneous Reduction of Co-Occurring Contaminants

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

J. Change in Risk From Other Contaminants

    All surface water systems are already required to disinfect under 
the SWTR (USEPA 1989b, 54 FR 27486, June 29, 1989) but this rule could 
impact currently non-disinfecting ground water systems. When 
disinfection is first introduced into a previously undisinfected GW 
system, the disinfectant can react with pipe scale causing increased 
risk from some contaminants that may be entrained in the pipe scales 
and other water quality problems. Examples of contaminants that could 
be released include lead, copper, and arsenic. Disinfection could also 
possibly lead to a temporary discoloration of the water as the scale is 
loosened from the pipe. These risks can be addressed by gradually 
phasing in disinfection to the system, by targeted flushing of 
distribution system mains, and by maintaining a proper corrosion 
control program.
    Introducing a disinfectant could also result in an increased risk 
from disinfection byproducts (DBPs). Risk from DBPs has already been 
addressed in the Stage 1 Disinfection Byproducts Rule (DBPR) (USEPA 
1998c) and additional consideration of DBP risk has been addressed in 
the final Stage 2 DBPR (USEPA 2006e). In general, ground water systems 
are less likely to experience high levels of DBPs than surface water 
systems because they have lower levels of naturally occurring organic 
materials (generally represented by total organic carbon (TOC)) that 
contribute to DBP formation.
    EPA does not expect many previously undisinfected systems to add 
disinfection as a result of either the AIP or Alternative rule options. 
Ground water systems that are not currently disinfecting may eventually 
install disinfection if RTCR distribution system monitoring and 
assessments, and/or subsequent source water monitoring required under 
the GWR, result in the determination that source water treatment is 
required. However, these impacts were already accounted for and costed 
under the GWR and EPA does not project additional systems switching to 
disinfection as a result of the RTCR. See section 7.4.6 of the Proposed 
RTCR EA (USEPA 2010a) for a discussion on corrective action.

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

    As discussed previously in this preamble, fecal contamination may 
contain waterborne pathogens including bacteria, viruses, and parasitic 
protozoa. Fecal contamination and waterborne pathogens can cause a 
variety of illnesses, including acute gastrointestinal illness (AGI) 
with diarrhea, abdominal discomfort, nausea, vomiting, and other 
symptoms. Most AGI cases are of short duration and result in mild 
illness. Other more severe illnesses caused by waterborne pathogens 
include hemolytic uremic syndrome (HUS) (kidney failure), hepatitis, 
and bloody diarrhea (WHO 2004). Chronic disease such as irritable bowel 
syndrome, reduced kidney function, hypertension and reactive arthritis 
can result from infection by a waterborne agent (Clark et al. 2008).
    When humans are exposed to and infected by an enteric pathogen, the 
pathogen becomes capable of reproducing in the gastrointestinal tract. 
As a result, healthy humans shed pathogens in their feces for a period 
ranging from days to weeks. This shedding of pathogens often occurs in 
the absence of any signs of clinical illness. Regardless of whether a 
pathogen causes clinical illness in the person who sheds it in his or 
her feces, the pathogen being shed may infect other people directly by 
person-to-person spread, contact with contaminated surfaces, and other 
means which are referred to as secondary spread. As a result, 
waterborne pathogens that are initially waterborne may subsequently 
infect other people through a variety of routes (WHO 2004).
    The general population typically experiences acute gastrointestinal 
illness (some illnesses may be severe such as kidney failure) when 
exposed to fecal contamination and/or waterborne pathogens. When 
sensitive subpopulations experience the same exposure as the general 
population,

[[Page 40989]]

more severe illness (and sometimes death) can occur.
    Examples of sensitive subpopulations are provided in chapter 2 of 
the Proposed RTCR EA (USEPA 2010a). This section discusses the 
potential health effects associated with sensitive population groups, 
especially children, pregnant women, and the elderly.
    It is anticipated that the requirements of the proposed RTCR will 
help reduce pathways of entry for fecal contamination and/or waterborne 
pathogens into the distribution system, thereby reducing risk to both 
the general population as well as to sensitive subpopulations.
1. Risk to Children, Pregnant Women, and the Elderly
    Children and the elderly are particularly vulnerable to kidney 
failure (hemolytic uremic syndrome) caused by the pathogenic bacterium 
E. coli O157:H7. Waterborne outbreaks due to E. coli O157:H7 have 
caused kidney failure in children and the elderly as the result of 
disease outbreaks from consuming ground water in Cabool, Missouri 
(Swerdlow et al. 1992); Alpine, Wyoming (Olsen et al. 2002); Washington 
County, New York (NY State DOH 2000); and Walkerton, Ontario, Canada 
(Health Canada 2000).
    The risk of acute illness and death due to viral contamination of 
drinking water depends on several factors, including the age of the 
exposed individual. Infants and young children have higher rates of 
infection and disease from enteroviruses than other age groups (USEPA 
1999). Several enteroviruses that can be transmitted through water can 
have serious health consequences in children. Enteroviruses (which 
include poliovirus, coxsackievirus, and echovirus) have been implicated 
in cases of flaccid paralysis, myocarditis, encephalitis, hemorrhagic 
conjunctivitis, and diabetes mellitus (Dalldorf and Melnick 1965; Smith 
1970; Berlin et al. 1993; Cherry 1995; Melnick 1996; CDC 1997; Modlin 
1997). Women may be at increased risk from enteric viruses during 
pregnancy (Gerba et al. 1996). Enterovirus infections in pregnant women 
can also be transmitted to the unborn child late in pregnancy, 
sometimes resulting in severe illness in the newborn (USEPA 2000d).
    Waterborne viruses can also be particularly harmful to children. 
Rotavirus disproportionately affects children less than five years of 
age (Parashar et al. 1998). However, the pentavalent rotavirus vaccine 
licensed for use in the United States has been shown to be 74 percent 
effective against rotavirus gastroenteritis of any severity (Dennehy 
2008). For echovirus, children are disproportionately at risk of 
becoming ill once infected (Modlin 1986). According to CDC, echovirus 
is not a vaccine-preventable disease (CDC 2009).
    The elderly are particularly at risk from diarrheal diseases (Glass 
et al. 2000) such as those associated with waterborne pathogens in the 
US. Approximately 53 percent of diarrheal deaths occur among those 
older than 74 years of age, and 77 percent of diarrheal deaths occur 
among those older than 64 years of age. In Cabool, Missouri (Swerdlow 
et al. 1992), a waterborne E. coli O157:H7 outbreak in a ground water 
system resulted in four deaths, all among the elderly. One death 
occurred from hemolytic uremic syndrome (kidney failure), the others 
from gastrointestinal illness.
    Hospitalizations due to diarrheal disease are higher in the elderly 
than younger adults (Glass et al. 2000). Average hospital stays for 
individuals older than 74 years of age due to diarrheal illness are 7.4 
days compared to 4.1 days for individuals aged 20 to 49 (Glass et al. 
2000).
    It is anticipated that the requirements of the proposed RTCR will 
help reduce pathways of entry for fecal contamination and/or waterborne 
pathogens into the distribution system, thereby reducing risk to both 
the general population as well as to sensitive subpopulations such as 
children, pregnant women, and the elderly.
2. Risk to Immunocompromised Persons
    AGI symptoms may be more severe in immunocompromised persons 
(Frisby et al. 1997; Carey et al. 2004). Such persons include those 
with acquired immune deficiency syndrome (AIDS), cancer patients 
undergoing chemotherapy, organ transplant recipients treated with drugs 
that suppress the immune system, and patients with autoimmune disorders 
such as lupus. In AIDS patients, Cryptosporidium, a waterborne 
protozoa, has been found in the lungs, ear, stomach, bile duct, and 
pancreas in addition to the small intestine (Farthing 2000). 
Immunocompromised patients with severe persistent cryptosporidiosis may 
die (Carey et al. 2004).
    For the immunocompromised, Gerba et al. (1996) reviewed the 
literature and reported that enteric adenovirus and rotavirus are the 
two waterborne viruses most commonly isolated in the stools of AIDS 
patients. For patients undergoing bone-marrow transplants, several 
studies cited by Gerba et al. (1996) reported mortality rates greater 
than 50 percent among patients infected with enteric viruses.
    It is anticipated that the requirements of the proposed RTCR will 
help reduce pathways of entry for fecal contamination and/or waterborne 
pathogens into the distribution system, thereby reducing risk to both 
the general population as well as to sensitive subpopulations such as 
the immunocompromised.

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

    A computer simulation model was used to estimate costs and 
indicators of benefits of the proposed RTCR. Exhibit VI-27 shows that 
these outputs depend on a number of key model inputs. This section 
describes analyses that were conducted to understand how uncertainties 
in these inputs contributed to uncertainty in model outputs.

[[Page 40990]]

[GRAPHIC] [TIFF OMITTED] TP14JY10.020

1. Inputs and Their Uncertainties
    It is anticipated that the requirements of the proposed RTCR will 
help reduce pathways of entry for fecal contamination and/or waterborne 
pathogens into the distribution system, thereby reducing exposure and 
illness from these contaminants in drinking water.
    These exposure and illness reductions could not be modeled and 
estimated quantitatively, due to a lack of a quantitative relationship 
between indicators and pathogens. Section VI.E.3 of this preamble and 
chapter 6 of the Proposed RTCR EA (USEPA 2010a) discuss this issue 
qualitatively.
    Model outputs include two important indicators of microbial 
exposure: E. coli occurrence in routine total coliform samples and the 
occurrence of Level 1 and 2 assessments. These outputs were monitored 
as endpoints in the sensitivity analyses described in this section.
    Quantified national cost estimates include costs of required 
monitoring, assessments, corrective actions, and public notifications. 
Total costs were monitored as end-points in the sensitivity analyses 
described in this section.
    None of the inputs shown in Exhibit VI-27 is perfectly known, so 
each has some degree of uncertainty. Some of these inputs are informed 
directly by data, so their uncertainties are due to limitations of the 
data. For example, uncertainty about the statistical model used to 
characterize occurrence is due to the limited numbers of systems and 
measurements per system in the Six-Year Review 2 dataset (USEPA 2010e). 
Other inputs are informed by professional judgment, so their 
uncertainties are expressed in terms of reasonable upper and lower 
bounds that are, themselves, based on expert judgment. For example, 10 
percent of assessments (representing the incremental increase over the 
current TCR) are expected to result in effective corrective actions, 
based on professional judgment, with reasonable upper and lower bounds 
of 20 percent and 5 percent, respectively.
    Sensitivity analyses were conducted to assess the degree to which 
uncertainties about selected inputs contribute to uncertainty in the 
resulting cost estimates. The analyses focused on the inputs that are 
listed in Exhibit VI-27. Varying the assumptions about the percentages 
of corrective actions identified and the effectiveness of those actions 
has a less than linear effect on outcomes, and the AIP option continues 
to be less costly than the Alternative option under all scenarios 
modeled. Exhibits 5.22a and 5.22b of the Proposed RTCR EA (USEPA 2010a) 
provide summaries of the driving model parameters and indicate where in 
the proposed RTCR EA the full discussion of uncertainty on each 
parameter is contained.

[[Page 40991]]

    Not shown in Exhibit VI-27 are some inputs that are very well 
known. These are inventory data, which include the list of all PWSs 
affected by the proposed RTCR and, for each system, information on its 
source water type, disinfection practice, and population served. 
Although this information is not perfect, any uncertainty is believed 
to have negligible impact on model outputs. EPA did not conduct 
sensitivity analyses to evaluate the importance of these small 
uncertainties.
2. Sensitivity Analysis
    Default values of the model inputs are considered reasonable best-
estimates. Model outputs that are obtained when the inputs are set to 
these default values are also considered to be reasonable best-
estimates. EPA conducted sensitivity analyses to learn how much the 
outputs might change when individual inputs are changed from their 
default values. The approach taken was to change each input to some 
reasonable upper and lower bounds, based on professional judgment.
    Many of the uncertainties are expected to impact the model output 
in a similar fashion for the current TCR, AIP, and the Alternative 
options. For example, an increase in a total coliform occurrence tends 
to increase the total cost and benefit estimates for all of the rule 
alternatives. Because the benefit and cost analyses focus on net 
changes among the current TCR, AIP, and Alternative options, these 
common sources of uncertainty may tend to cancel out in the net change 
analyses. Other uncertainties were expected to have stronger influence 
on net changes among the current TCR, AIP, and Alternative options 
because they influence some options, but not others. For example, 
assumptions about the effectiveness of corrective actions influences 
total costs of the proposed RTCR options, but not the current TCR 
option itself.
    Results of the sensitivity analyses (reported in the Proposed RTCR 
EA (USEPA 2010a)) showed that the fundamental conclusions of the 
economic analysis do not change over a wide range of assumptions. Both 
the AIP and Alternative options provide benefits as compared to the 
current TCR. Varying key assumptions has a less than linear effect on 
outcomes, and the AIP option continues to be less costly than the 
Alternative option under all scenarios modeled. See section 5.3.3.1 of 
the Proposed RTCR EA (USEPA 2010a) for details.

M. Benefit Cost Determination for the Proposed RTCR

    Pursuant to SDWA section 1412(b)(6)(A), EPA has determined that the 
benefits of the proposed RTCR justify the costs. In making this 
determination, EPA considered quantified and nonquantified benefits and 
costs as well as the other components of the HRRCA outlined in section 
1412(b)(3)(C) of the SDWA.
    Additionally, EPA used several other techniques to compare benefits 
and costs including a break-even analysis and a cost effectiveness 
analysis. The break-even analysis (see chapter 9 of the Proposed RTCR 
EA (USEPA 2010a)) was conducted using two example pathogens responsible 
for some (unknown) proportion of waterborne illnesses in the United 
States: shiga toxin-producing EC O157:H7 \1\ (STEC O157:H7) and 
Salmonella. Based on either example pathogen considered in the 
breakeven analysis, a small number of fatal cases annually would need 
to be avoided, relative to the CDC's estimate of cases caused by 
waterborne pathogens, in order to break even with rule costs. For 
example, under the AIP option, just two deaths would need to be avoided 
annually using a 3 percent discount rate based on consideration of the 
bacterial pathogen STEC O157:H7. Alternatively, approximately 3,000 or 
8,000 non-fatal cases, using the enhanced or traditional benefits 
valuations approaches,\2\ respectively, would need to be avoided to 
break even with rule costs. As expected based on its costs, the lower 
cost of the AIP option relative to the Alternative option means that 
fewer cases need to be avoided in order to break even. See Exhibit VI-
28.
---------------------------------------------------------------------------

    \1\ 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.''
    \2\ Both traditional and enhanced COI approaches count the value 
of the direct medical costs and of time lost that would been spent 
working for a wage, but differ in their assessment of the value of 
time lost that would be spent in nonmarket work (e.g., housework, 
yardwork, and raising children) and leisure (e.g., recreation, 
family time, and sleep). They also differ in their valuation of 
(other) disutility, which encompasses a range of factors of well 
being, including both inconvenience and any pain and suffering. A 
complete discussion of the traditional and enhanced COI approaches 
can be found in Appendix E of the RTCR EA (USEPA 2010a).
---------------------------------------------------------------------------

    As Exhibit VI-28 shows, approximately 2 deaths would need to be 
avoided from a Salmonella infection for the rule to break even. The 
estimated number of non-fatal Salmonella cases that would need to be 
avoided to break even is approximately 10,000 or 65,000 cases under the 
enhanced and traditional benefits valuations approaches, respectively. 
Given the large number of potential waterborne pathogens shown to occur 
in PWSs and the relatively low net costs of the proposed RTCR, EPA 
believes, as discussed in this section and in the Proposed RTCR EA 
(USEPA 2010a), that the AIP option is likely to at least break even. 
Chapter 9 of the Proposed RTCR EA (USEPA 2010a) has a complete 
discussion of the break-even analysis and how costs per case were 
calculated.

                            Exhibit VI-28--Estimated Breakeven Threshold for Avoided Cases of E. coli O157:H7 and Salmonella
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              AIP option                      Alternative option
                                                                  Discount rate  -----------------------------------------------------------------------
               Cost of illness (COI) methodology                    (percent)      Non-fatal cases  Fatal cases only   Non-fatal cases  Fatal cases only
                                                                                        only               \1\              only               \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. coli O157:H7:
    Traditional COI...........................................                 3             8,000               1.6            16,000               3.1
                                                                               7             8,000               1.5            17,000               3.4
    Enhanced COI..............................................                 3             3,000               1.6             5,000               3.1
                                                                               7             3,000               1.5             6,000               3.4
Salmonella:
    Traditional COI...........................................                 3            65,000               1.6           130,000               3.1
                                                                               7            65,000               1.6           141,000               3.4
    Enhanced COI..............................................                 3            10,000               1.6            20,000               3.1

[[Page 40992]]

                                                                               7            10,000               1.6            21,000               3.4
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Calculations for fatal cases include the non-fatal cost of illness (COI) component for the underlying illness prior to death.
Note: The number of cases needed to reach break-even threshold is calculated by dividing the net change in costs for the proposed RTCR by the average
  estimated value of avoided cases.
E. coli O157:H7 and Salmonella are only two of multiple pathogenic endpoints that could have been used for this analysis. Use of additional pathogenic
  contaminants in addition to these single endpoints would result in lower threshold values.
Detail may not add due to independent rounding.
Differences in the three percent and seven percent estimates among the AIP and Alternative Analysis can be explained by how costs accrue over the period
  of analysis. Cost for the AIP are relatively consistent across the period of analysis while greater costs for the Alternative occur early in the rule
  implementation period due to increases in monitoring and corrective actions.

    Cost-effectiveness is another way of examining the benefits and 
costs of the proposed rule. Exhibit VI-29 shows the cost of the rule 
per corrective action avoided. The cost-effectiveness analysis, as with 
the net benefits, is limited because EPA was able to only partially 
quantify and monetize the benefits of the proposed RTCR. As discussed 
previously and demonstrated in the Proposed RTCR EA (USEPA 2010a), the 
proposed rule, i.e., the AIP option, achieves the lowest cost per 
corrective action avoided among the options considered. The incremental 
cost-effectiveness analysis shows that the AIP has a lower cost per 
corrective action than the Alternative option.

     Exhibit VI-29--Total Net Annual Cost per Corrective Action (CA)
 Implemented Under AIP and Alternative Options, Annualized (Using Three
                Percent and Seven Percent Discount Rates)
                                 [$2007]
------------------------------------------------------------------------
                                                3% Discount  7% Discount
              Regulatory scenario                   rate         rate
------------------------------------------------------------------------
AIP Net Cost ($ Millions).....................        $13.7        $13.7
AIP Net Corrective Actions (L1 & L2)..........          598          555
AIP Cost Effectiveness Analysis (CEA) (net          $22,899      $24,610
 rule cost/CA)................................
Alternative Option Net Cost...................        $27.2        $29.7
Alternative Option Net Corrective Actions (L1           785          765
 & L2)........................................
Alternative Option CEA (net rule cost/CA).....      $34,718      $39,812
------------------------------------------------------------------------
Note: Corrective actions include those conducted as a result either
  Level 1 or Level 2 assessments. Total rule costs are shown in Exhibit
  9.14 of the Proposed RTCR EA (USEPA 2010a). Detailed benefits and cost
  information is provided in Appendices A and C, respectively, of the
  Proposed RTCR EA (USEPA 2010a).

    EPA also considered the incremental cost-effectiveness of the AIP 
option as compared to the Alternative option to determine the 
additional benefit associated with the portion of cost for the 
Alternative option that exceeds the cost of the AIP option. Exhibit VI-
30 shows that in incremental terms for all PWSs, the AIP option has a 
far lower unit cost per corrective action than the Alternative option. 
EPA further considered the group of 60,200 TNCWSs serving 100 or fewer 
people and using GW, which are the largest subset of systems by size 
and type. This group is expected to bear the highest aggregate burden 
under the proposed RTCR because of the number of systems in the group, 
but the per system cost of this group is relatively low, ($83 
annualized at 3% discount in 2007$). The two incremental analyses 
(Exhibit VI-30 and Exhibit VI-31) together indicate that, using a three 
percent discount rate to compare incremental benefits and costs, the 
AIP option is significantly more cost-effective than the Alternative 
option by a factor of about four for the most burdened subset of 
systems and by a factor of greater than three when considering all PWSs 
together. Additional information about this analysis and other methods 
used to compare benefits and costs can be found in chapter 9 of the 
Proposed RTCR EA (USEPA 2010a).

     Exhibit VI-30--Incremental Rule Cost per Corrective Action (CA)
 Implemented Under AIP and Alternative Options, Annualized (Using Three
                Percent and Seven Percent Discount Rates)
                                 [$2007]
------------------------------------------------------------------------
                                            3% Discount     7% Discount
           Regulatory scenario                 rate            rate
------------------------------------------------------------------------
A. AIP Incremental Net Costs ($                    $13.7           $13.7
 millions) \ 1\.........................
B. AIP Incremental Net Corrective                    598             555
 Actions (L1 & L2) \ 1\.................
C. AIP Incremental Cost per CA ($) (C =          $22,899         $24,610
 A/B)...................................
D. Alternative Option Incremental Net              $13.5           $16.0
 Costs ($ millions) \ 2\................
E. Alternative Option Incremental Net                187             210
 Corrective Actions (L1 & L2)\ 2\.......
F. Alternative Option Incremental Cost           $72,582         $76,299
 per CA ($) (F = D/E)...................
------------------------------------------------------------------------
Notes: Detail may not add due to independent rounding.

[[Page 40993]]

Exhibit includes only the number of corrective actions predicted by the
  RTCR occurrence model to be implemented in addition to those
  implemented under the current TCR. Includes corrective actions (CAs)
  in response to both Level 1 and Level 2 assessments. Total net costs
  for each option and total CAs (not incremental) are shown in Exhibit
  9.15 of the Proposed RTCR EA (USEPA 2010a). Detailed benefits and cost
  information is provided in Appendices A and C, respectively, of the
  Proposed RTCR EA (USEPA 2010a).
\1\ Represents the incremental increase of the AIP option over the
  current TCR.
\2\ Represents the incremental increase of the Alternative option over
  AIP option. Add incremental net values for Alternative option to
  incremental net values for AIP option to calculate total net values of
  Alternative option over current TCR.

   Exhibit VI-31--Incremental Rule Cost per Corrective Action (CA) for
     TNCWSs Using GW Implemented Under AIP and Alternative Options,
    Annualized (Using Three Percent and Seven Percent Discount Rates)
                                 [2007]
------------------------------------------------------------------------
                                            3% Discount     7% Discount
           Regulatory scenario                 rate            rate
------------------------------------------------------------------------
1. AIP Incremental Net Costs ($                     $5.1            $5.1
 millions) \1\..........................
2. AIP Incremental Corrective Actions                279             257
 (L1 & L2) (TNCWS < 101 only) \1\.......
3. AIP Incremental Cost per CA ($)......         $18,219         $19,965
4. Alternative Option Incremental Net               $8.3            $9.8
 Costs ($ millions) \2\.................
5. Alternative Option Incremental                    128             145
 Corrective Actions (L1 & L2) (TNCWS <
 101 only) \2\..........................
6. Alternative Option Incremental Cost           $64,731         $67,762
 per CA ($).............................
------------------------------------------------------------------------
\1\ Represents the incremental increase of the AIP option over the
  current TCR.
\2\ Represents the incremental increase of the Alternative option over
  AIP option. Add incremental net values for Alternative option to
  incremental net values for AIP option to calculate total net values of
  Alternative option over current TCR.
Note: Detail may not add due to independent rounding.
Incremental Net Costs are based on TNCWSs serving < 101 people. Detailed
  benefits and cost information is provided in Appendices A and C,
  respectively, of the Proposed RTCR EA (USEPA 2010a).

    The preferred option for the proposed RTCR is the AIP option. The 
analyses performed as part of the Proposed RTCR EA (USEPA 2010a) 
support the collective judgment and consensus of the advisory committee 
that the AIP requirements provide for effective and efficient revisions 
to the current TCR regulatory requirements. The estimated net cost of 
the AIP option is small ($14M annually) as compared to the current TCR 
and small compared to the net cost of the Alternative option ($27M-
$30M) as compared with the current TCR. In addition, the net benefits 
are expected to be positive under the AIP option and no backsliding in 
overall risk is predicted. While the number of corrective actions under 
the Alternative option is greater than under the AIP option, the 
achievement of these benefits is not as cost effective as under the AIP 
option.
    EPA's Proposed RTCR EA (USEPA 2010a) shows that additional 
monitoring is likely to lead to more corrective actions under the 
Alternative option than under either the current TCR option or the AIP 
option. The EPA Science Advisory Board (SAB) noted in its analysis of 
the EA (described in section VII.K of this preamble) that they are not 
generally supportive of decreased monitoring, and that overall, the 
Alternative option appears to address and protect public health sooner 
in time than the AIP proposed implementation. However, EPA concluded 
that the increased costs associated with the Alternative option are not 
justified by the increased benefits because under the AIP option, 
States could conduct site visits in place of increased monitoring and 
such site visits are more protective of public health. In particular, 
the cost-effectiveness analysis shows that the Alternative option is 
not as cost-effective as the proposed AIP option.

N. Request for Comment on the Economic Analysis

    EPA requests comment on the following aspects of the Proposed RTCR 
EA (USEPA 2010a):
     The EPA Science Advisory Board (SAB) noted in its review 
of the Proposed RTCR EA that overall, the Alternative option appears to 
address and protect public health sooner in time than the AIP proposed 
implementation. The SAB is concerned about decreased monitoring in the 
AIP option, compared to the Alternative option. Although the AIP option 
contains less overall monitoring than the Alternative option, EPA 
believes that having States conducting site visits in place of 
increased monitoring under the AIP option is more protective of public 
health. As discussed in this section, EPA evaluates the costs and 
benefits of all options and prefers the AIP option because the 
increased costs associated with the Alternative option are not 
justified by the increased short term benefits. EPA requests comment on 
whether this determination is reasonable and how the RTCR may best 
address the SAB's concern that the Alternative option appears to 
protect public health sooner in time than the proposed AIP option.
    In addition, the SAB noted in its review that measures other than 
total coliform may provide valuable supplemental information on the 
health risks of distributed water. The SAB provided example measures 
such as water age, biofilm assessment, implementation of Best 
Management Practices, indicators that would inform the structural and 
hydraulic integrity of distribution system, etc. The TCRDSAC also 
suggested that EPA develop measures to evaluate the long-term 
effectiveness of the rule. EPA requests comment on the measures that 
may be monitored and tracked to indicate the long-term effectiveness of 
the RTCR and how these measures may be implemented effectively.
     Major distribution system appurtenances such as storage 
tanks generally have a useful life that is accounted for in water 
system capital planning. While the assessments conducted under RTCR 
could identify when that useful life has ended, EPA assumes the 
replacement or maintenance of appurtenances is part of a water system's 
operations and maintenance activities and the associated cost is 
accounted for in its capital planning. During the TCRDSAC's 
deliberation, EPA worked closely with stakeholders to derive this 
assumption and, consistent with the discussions of the TCRDSAC 
regarding major structural fixes or replacements, EPA's analysis did 
not account for these costs as part of the cost of the RTCR, although 
such fixes may be undertaken to address sanitary defects identified in 
a Level 1 or Level 2 assessment. EPA

[[Page 40994]]

requests comment on whether the assumption is reasonable. Are there 
alternative approaches that could be used to address this issue? If so, 
what would be the basis?
     In calculating the State cost of the rule, EPA assumed 
that, based on stakeholder input and the cost of annual site visits, 
only those States that currently allow annual monitoring and conduct 
annual site visits under TCR would continue under the RTCR. EPA 
requests comment on whether this assumption is reasonable. Are there 
alternative approaches that could be used to derive a more reasonable 
assumption? If so, what would be the basis?
     In analyzing the potential benefits of the proposed RTCR, 
EPA assumed that 10 percent of Level 1 and Level 2 assessments under 
the RTCR would lead to corrective action above what is already 
occurring under the current TCR. This assumption was based on 
conversations with States. However, EPA recognizes that information 
about corrective actions conducted under the current TCR is limited and 
requests comment on this assumption and any information that relates to 
it.
     In assessing the benefits of the rule, EPA assumed that 
because Level 2 assessments would be more comprehensive investigations 
than Level 1 assessments, they would generally result in finding more 
substantial problems than Level 1 assessments and would be more 
effective at reducing future occurrences of total coliforms and E. 
coli. Specifically, for modeling purposes, EPA assumed that, on 
average, systems performing corrective action as a result of a Level 1 
assessment will experience no positive samples for the remainder of the 
year and one additional year, and will experience a 50 percent 
reduction in occurrence for three additional years, while systems 
performing corrective action as a result of a Level 2 assessment will 
experience no positive sample for the remainder of the year and two 
additional years, and a 75 percent reduction in occurrence for five 
additional years. EPA requests comment on whether these assumptions are 
reasonable, as well as any data or experience that commenters may 
provide that bears on the effectiveness of corrective action at 
reducing occurrence. Specifically, what differences between a Level 2 
and Level 1 assessment would lead the former to identify more 
substantial problems and result in greater, longer-lasting occurrence 
reductions?

VII. Statutory and Executive Order Review

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is a significant regulatory action. Accordingly, EPA submitted 
this action to the Office of Management and Budget (OMB) for review 
under Executive Order 12866 and any changes made in response to OMB 
recommendations have been documented in the docket for this action.
    EPA estimates that the proposed RTCR will have an overall impact on 
public water systems of $14 M and that the impact on small entities 
(PWSs serving 10,000 people or fewer) will be $9.4 M-$9.8 M annualized 
at 3 and 7 percent discount rates, respectively. These impacts are 
described in sections VI and VII.C of this preamble, respectively, and 
in the analysis that EPA prepared of the potential costs and benefits 
of this action, contained in the Proposed RTCR EA (USEPA 2010a).

B. Paperwork Reduction Act

    The information collection requirements for the proposed RTCR have 
been submitted for approval to the OMB under the Paperwork Reduction 
Act, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) 
document prepared by EPA has been assigned EPA ICR number 1895.06.
    The Paperwork Reduction Act requires EPA to estimate the burden on 
public water systems (PWSs) and State/primacy Agencies of complying 
with the rule. The information collected as a result of EPA's efforts 
toward proposing the proposed RTCR should allow States/primacy agencies 
and EPA to determine appropriate requirements for specific systems and 
evaluate compliance with the proposed RTCR. Burden is defined at 5 CFR 
1320.3(b) and means the total time, effort, and financial resources 
required to generate, maintain, retain, disclose, or provide 
information to or for a Federal agency. The burden includes the time 
needed to conduct the following State and public water system (PWS) 
activities:
    State activities:
     Read and understand the rule;
     Mobilize (including primacy application), plan, and 
implement;
     Train PWS and consultant staff;
     Track compliance;
     Analyze and review PWS data;
     Review sampling plans and recommend any revisions to PWSs;
     Make determinations concerning PWS monitoring 
requirements;
     Respond to PWSs with positive samples;
     Recordkeeping;
     Review completed assessment forms and consult with the PWS 
about the assessment report;
     Review and coordinate with PWSs to determine optimal 
corrective actions to be implemented; and
     Provide consultation, review public notification 
certifications, and file reports of violations.
    PWS activities:
     Read and understand the rule;
     Planning and mobilization activities;
     Revise existing sampling plans to identify sampling 
locations and collection schedules that are representative of water 
throughout the distribution system;
     Conduct routine, additional routine, and repeat 
monitoring;
     Complete a Level 1 Assessment if the PWS experiences a 
Level 1 trigger, and submit a timetable to the State to identify 
sanitary defects detected, corrective actions completed, and a 
timetable for any corrective actions not already completed;
     Complete a Level 2 Assessment if the PWS experiences a 
Level 2 trigger, and submit a timetable for any corrective actions not 
already completed;
     Correct sanitary defects found through the performance of 
Level 1 or Level 2 assessments;
     Develop and distribute Tier 1 public notices when E. coli 
MCL violations occur;
     Develop and distribute Tier 2 public notices when the PWSs 
failed to take corrective action; and
     Develop and distribute Tier 3 public notices when the PWSs 
failed to comply with the monitoring requirements or with mandatory 
reporting of required information within the specified timeframe.
    For the first three years after publication of the final rule in 
the Federal Register, the major information requirements apply to 
154,894 respondents. The total incremental burden associated with the 
change in moving from the information requirements of the current TCR 
to those in the proposed RTCR over the three years covered by the ICR 
is 2,518,878 hours, for an average of 839,526 hours per year. The total 
incremental cost over the three year clearance period is $71.3 million, 
for an average of $23.8 million per year (simple average over three 
years). (Note that this is higher than the annualized costs for the 
proposed rule because in the EA, the up-front costs that occur in the 
first three years, as well as future costs, are annualized over a 25-
year time

[[Page 40995]]

horizon). The average burden per response (i.e., the amount of time 
needed for each activity that requires a collection of information) is 
5.4 hours; the average cost per response is $153.4. The collection 
requirements are mandatory under SDWA (42 U.S.C. 300h et seq.). Detail 
on the calculation of the proposed rule information collection burden 
and costs can be found in the Information Collection Request for the 
Proposed Revised Total Coliform Rule (USEPA 2010d) and chapter 7 of the 
EA (USEPA 2010a). A summary of the burdens and costs of the proposed 
collection is presented in Exhibit VII-1.

                                   Exhibit VII-1--Average Annual Net Change Burden and Costs for the Proposed RTCR ICR
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                 Cost
                                                               ------------------------------------------------------------------------
               Respondent type                  Annual burden                     Annual operation                                      Annual responses
                                                    hours         Annual labor      & maintenance    Annual capital     Total annual
                                                                      cost           (O&M) cost           cost              cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
PWSs........................................           747,848       $20,171,639                $0                $0       $20,171,639           103,225
States and Territories......................            91,678         3,595,421                 0                 0         3,595,421            51,669
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................           839,526        23,767,060                 0                 0        23,767,060           154,894
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: Detail may not add exactly to total due to independent rounding.
``Annual Burden Hours'' reflects an annual average for all system sizes over the 3-year ICR period.
Source: Information Collection Request for the Proposed Revised Total Coliform Rule (USEPA 2010d).

    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in 40 CFR are listed in 40 CFR part 9. To comment on EPA's 
need for this information, the accuracy of the provided burden 
estimates, and any suggested methods for minimizing respondent burden, 
EPA has established a public docket for this proposed rule, which 
includes this ICR, under Docket ID number EPA-HQ-OW-2008-0878. Submit 
any comments related to the ICR to EPA and OMB. See ADDRESSES section 
at the beginning of this notice for where to submit comments to EPA. 
Send comments to OMB at the Office of Information and Regulatory 
Affairs, Office of Management and Budget, 725 17th Street, NW., 
Washington, DC 20503, Attention: Desk Officer for EPA. Since OMB is 
required to make a decision concerning the ICR between 30 and 60 days 
after July 14, 2010, a comment to OMB is best assured of having its 
full effect if OMB receives it by August 13, 2010. The final rule will 
respond to any OMB or public comments on the information collection 
requirements contained in this proposal.

C. Regulatory Flexibility Act (RFA)

    The Regulatory Flexibility Act (RFA) generally requires an agency 
to prepare a regulatory flexibility analysis of any rule subject to 
notice and comment rulemaking requirements under the Administrative 
Procedure Act or any other statute unless the agency certifies that the 
rule will not have a significant economic impact on a substantial 
number of small entities. Small entities include small businesses, 
small organizations, and small governmental jurisdictions.
    The RFA provides default definitions for each type of small entity. 
Small entities are defined as: (1) A small business as defined by the 
Small Business Administration's (SBA) regulations at 13 CFR 121.201; 
(2) a small governmental jurisdiction that is a government of a city, 
county, town, school district or special district with a population of 
less than 50,000; and (3) a small organization that is any ``not-for-
profit enterprise which is independently owned and operated and is not 
dominant in its field.'' However, the RFA also authorizes an agency to 
use alternative definitions for each category of small entity, ``which 
are appropriate to the activities of the agency'' after proposing the 
alternative definition(s) in the Federal Register and taking comment. 5 
USC 601(3)-(5). In addition, to establish an alternative small business 
definition, agencies must consult with SBA's Chief Counsel for 
Advocacy.
    For purposes of assessing the impacts of the proposed RTCR on small 
entities, EPA considered small entities to be PWSs serving fewer than 
10,000 people. This is the cut-off level specified by Congress in the 
1996 Amendments to the Safe Drinking Water Act for small system 
flexibility provisions. As required by the RFA, EPA proposed using this 
alternative definition in the Federal Register (63 FR 7620, February 
13, 1998), requested public comment, consulted with the SBA, and 
finalized the alternative definition in the Consumer Confidence Reports 
regulation (63 FR 44524, August 19, 1998). As stated in that Final 
Rule, the alternative definition would be applied for all future 
drinking water regulations.
    After considering the economic impacts of today's proposed rule on 
small entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. The small 
entities directly regulated by this proposed rule are small PWSs 
serving fewer than 10,000 people. These include small CWSs, NTNCWSs, 
and TNCWSs, entities such as municipal water systems (publicly and 
privately owned), and privately-owned PWSs and for profit businesses 
where provision of water may be ancillary, such as mobile home parks, 
day care centers, churches, schools and homeowner associations. We have 
determined that only 61 of 150,672 small systems (0.04%) will 
experience an impact of more than 1% of revenues, and that none of the 
small systems will experience an impact of 3% or greater of revenue. 
This information is described further in chapter 8 of the Proposed RTCR 
EA (USEPA 2010a).
    Although this proposed rule will not have a significant economic 
impact on a substantial number of small entities, EPA nonetheless has 
tried to reduce the impact of this rule on small PWSs. Provisions in 
the proposed RTCR that result in reduced costs for many small entities 
include:
     Reduced routine monitoring for qualifying PWS serving 
1,000 or fewer people.
     Reduced number of repeat samples required.
     Reduced additional routine monitoring for PWS serving 
4,100 or fewer people.
     Reduced public notification requirements for all systems, 
including small systems.
    EPA also conducted outreach to small entities and convened a Small 
Business Advocacy Review Panel to obtain advice

[[Page 40996]]

and recommendations of representatives of the small entities that 
potentially would be subject to the proposed rule's requirements. EPA 
consulted with small entity representatives before and during the 
review by the Panel. These small entity representatives included 
representatives from small water systems of various types and sizes, 
representatives from associations that assist and/or advocate for small 
systems, and Federal agencies that operate small systems. Panel members 
included representatives from OMB, the Small Business Administration, 
and the EPA Office of Ground Water and Drinking Water. The consultation 
led to the development of a report providing recommendations to EPA on 
how to revise the TCR to address small system concerns, which EPA 
considered in drafting this proposed RTCR (SBAR Panel 2008). EPA also 
made presentations to the advisory committee on the recommendations of 
the Panel so the advisory committee could consider their 
recommendations in developing the AIP.
    Consistent with the RFA/Small Business Regulatory Enforcement 
Fairness Act (SBREFA) requirements, the Panel evaluated the assembled 
materials and small-entity comments on issues and prepared a final 
report to the EPA Administrator. A copy of the Panel report is included 
in the docket for this proposed rule. The proposed rule is consistent 
with the Panel recommendations to use total coliforms as a trigger for 
investigation and/or corrective action, to balance monitoring 
requirements and costs with risk, to further differentiate requirements 
based on differences in water systems, to coordinate requirements with 
other related rules, and to consider reporting and recordkeeping costs 
in estimating burden. Consistent with the Panel recommendation to 
evaluate which parameters are most appropriate for routine monitoring 
and as potential triggers for investigative and corrective actions, EPA 
is conducting a review of existing methods for total coliform and E. 
coli analysis and is evaluating its Alternative Test Procedure protocol 
for approving new methods as described in section III.A.9 of this 
preamble. EPA is also one of the founding members of a Research and 
Information Collection Partnership, described in section V of this 
preamble, which is considering research and information needs to 
evaluate the magnitude of risks and potential risk mitigation options 
related to potential distribution system contamination.
    We continue to be interested in the potential impacts of the 
proposed rule on small entities and welcome comments on issues related 
to such impacts.

D. Unfunded Mandates Reform Act (UMRA)

    This proposed rule does not contain a Federal mandate that may 
result in expenditures to State, local, and Tribal governments, in the 
aggregate, or to the private sector, of $100 million or more in any one 
year. Expenditures associated with compliance, defined as the 
incremental costs beyond the current TCR, will not surpass $100 million 
in the aggregate in any year. Thus, this proposed rule is not subject 
to the requirements of sections 202 and 205 of UMRA.
    This proposed rule is also not subject to the requirements of 
section 203 of UMRA because it contains no regulatory requirements that 
might significantly or uniquely affect small governments. Costs to 
small entities are generally not significant, as described previously 
in section VII.C and are detailed in the Proposed RTCR EA (2010a). The 
regulatory requirements of the proposed RTCR are not unique to small 
governments, as they apply to all PWSs regardless of size.

E. Executive Order 13132: Federalism

    This action does not have Federalism implications. It will not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government as 
specified in Executive Order 13132. The net change in cost for State, 
local, and Tribal governments in the aggregate is estimated to be 
approximately $0.1M and $0.4M at three percent and seven percent 
discount rates, respectively. Thus, Executive Order 13132 does not 
apply to this proposed rule.
    Although section 6 of Executive Order 13132 does not apply to the 
proposed RTCR, EPA conducted a Federalism Consultation, consistent with 
Executive Order 13132, in July 2008. The consultation included a 
stakeholder meeting where EPA requested comments on the impacts of the 
potential revisions to the TCR with respect to State, county and local 
governments. EPA did not receive any comments in response to this 
consultation. In addition, the advisory committee included 
representatives of State, local and Tribal governments, and through 
this process EPA consulted with State, local, and Tribal government 
representatives to ensure that their views were considered when the AIP 
recommendations for the RTCR were developed.
    In the spirit of Executive Order 13132, and consistent with EPA 
policy to promote communications between EPA and State and local 
governments, EPA specifically solicits comment on this proposed action 
from State and local officials.

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

    This action does not have tribal implications, as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000). Thus, Executive 
Order 13175 does not apply to this action.
    Although Executive Order 13175 does not apply to this action, EPA 
consulted with Tribal officials in developing this action. EPA has 
consulted with Tribal governments through the EPA American Indian 
Environmental Office, included a representative of the Native American 
Water Association on the advisory committee which developed 
recommendations regarding the proposed rule and signed the AIP, and has 
addressed Tribal concerns throughout the regulatory development 
process, as appropriate. The consultation included participation in 
three Tribal conference calls (EPA regional Tribal call (February 
2008), National Indian Workgroup call (March 2008), and National Tribal 
Water Conference (March 2008)). EPA requested comments on the current 
TCR, requested suggestions for current TCR revisions (March 2008), and 
presented possible revisions to the current TCR to the National Tribal 
Council (April 2008). In addition, the advisory committee included 
entities representing Tribal governments, and through this process EPA 
ensured that their views were considered when the AIP recommendations 
for the RTCR were developed. None of these consultations identified 
issues that were particular to Tribal entities. As a result of the 
Tribal consultations and other Tribal outreach, EPA has determined that 
the proposed RTCR is not anticipated to have a negative impact on 
Tribal systems. Thus, Executive Order 13175 does not apply to this 
action.
    EPA specifically solicits additional comment on this proposed 
action from Tribal officials.

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

    The proposed RTCR is not subject to Executive Order 13045 (62 FR 
19885, April 23, 1997) because it is not economically significant as 
defined in

[[Page 40997]]

Executive Order 12866. This action's health and risk assessments 
regarding children are contained in section VI.K.1 of this preamble and 
in the Proposed RTCR EA (USEPA 2010a). EPA expects that the proposed 
RTCR would provide additional protection to both children and adults 
who consume drinking water supplied from PWSs. EPA also believes that 
the benefits of the proposed rule, including reduced health risk, 
accrue more to children because young children are more susceptible 
than adults to some waterborne illnesses. For example, the risk of 
mortality resulting from diarrhea is often greatest in the very young 
and elderly (Rose 1997; Gerba et al. 1996), and viral and bacterial 
illnesses often disproportionately affect children. Any overall 
benefits of the rule would reduce this mortality risk for children.
    The public is invited to submit comments or identify peer-reviewed 
studies and data that assess effects of early life exposure to drinking 
water that contains fecal contaminants.

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

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

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, 12(d) (15 U.S.C. 272 note) 
directs EPA to use voluntary consensus standards in its regulatory 
activities unless to do so would be inconsistent with applicable law or 
otherwise impractical. Voluntary consensus standards are technical 
standards (e.g., materials specifications, test methods, sampling 
procedures, and business practices) that are developed or adopted by 
voluntary consensus standards bodies. NTTAA directs EPA to provide 
Congress, through OMB, explanations when EPA decides not to use 
available and applicable voluntary consensus standards.
    The proposed RTCR involves technical voluntary consensus standards. 
EPA proposes to use several analytical methods to monitor for total 
coliforms and/or E. coli as they are described in Standard Methods for 
the Examination of Water and Wastewater, 20th and 21st editions 
(Clesceri et al. 1998; Eaton et al. 2005). Methods included in Standard 
Methods are voluntary consensus standards. The proposed rule includes 
11 methods that can be used to test for total coliforms. Four of the 11 
are described in Standard Methods.
    EPA welcomes comments on this aspect of the proposed rulemaking 
and, specifically, invites the public to identify potentially-
applicable voluntary consensus standards and to explain why such 
standards should be used in this regulation.

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

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

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

    In accordance with section 1412(d) and (e) of the SDWA, EPA 
consulted with the Science Advisory Board (SAB), the National Drinking 
Water Advisory Council (NDWAC), and the Secretary of the U.S. 
Department of Health and Human Services on the proposed RTCR.
    EPA met with the Drinking Water Committee of the SAB to discuss the 
proposed RTCR on May 20, 2009 (teleconference) and June 9 and 10, 2009 
(Washington, DC). The SAB Drinking Water Committee (DWC) review focused 
on (1) the data sources used to estimate baseline total coliform and E. 
coli occurrence, public water system profile, and sensitive 
subpopulations in the United States; (2) the occurrence analysis used 
to inform the benefits analysis; (3) the qualitative analysis used to 
assess the reduction in risk due to implementation of the rule 
requirements; and (4) analysis of the engineering costs and costs to 
States resulting from implementation of the revisions.
    Overall, the SAB DWC supported EPA's analysis. SAB members 
commended EPA for making use of the best available data to assess the 
impacts of the proposed rule. The SAB DWC supported the decision by EPA 
not to quantify public health benefits, acknowledging that EPA had 
insufficient data to do so. However, they noted in their analysis of 
the EA that they are not generally supportive of decreased monitoring, 
and that overall, the Alternative option appears to address and protect 
public health sooner in time than the AIP proposed implementation. The 
SAB DWC recommended that EPA clarify rationales for assumptions; expand 
explanations of sensitivity analyses that were included; provide 
further justification in those areas in which sensitivity analyses were 
not conducted; and collect data after promulgation of the rule to allow 
EPA to better understand the public health impacts of the RTCR.
    In response to the SAB DWC recommendations, EPA conducted 
sensitivity analyses to explore a wider range of assumptions regarding 
the

[[Page 40998]]

percentage of assessments leading to corrective actions and to 
demonstrate that using an annual average for occurrence provided 
results comparable to varying the occurrence based on the season. EPA 
also added an exhibit in the EA that summarizes all significant model 
parameters and assumptions, their influence on variability and 
uncertainty, and their most likely effect on benefits or costs. In 
addition, EPA added a request for comment to this preamble to obtain 
suggestions about what data should be collected and used to better 
understand the impacts of the RTCR. The added exhibits and expanded and 
clarified text can be found in the Proposed RTCR EA (USEPA 2010a). A 
copy of the SAB report (SAB 2010) is available in the docket for the 
proposed RTCR.
    EPA consulted with NDWAC on May 28, 2009, in Seattle, Washington, 
to discuss the proposed RTCR. NDWAC members expressed concern that a 
rule based on the AIP sounds complicated. Education was a common theme 
in the responses from NDWAC members. Some members recommended that EPA 
provide the utilities and States with tools to help them understand the 
revised rule provisions and to assist with providing public education. 
A few members stated that they would like to provide EPA with 
additional advice on public notification. In response to NDWAC's 
concern, EPA is requesting comment on whether the proposed RTCR would 
result in requirements that would be easier to implement compared to 
the current TCR.
    NDWAC members also suggested that EPA request comment on the costs 
and benefits of reduced monitoring. Specifically, NDWAC expressed 
concern that a reduction in the number of certain samples taken (such 
as the reduction in the number of repeat and additional routine samples 
for some small systems) could lessen the opportunity for systems to 
identify violations. Thus, EPA is requesting comment on the cost and 
benefit of reduced monitoring.
    A few NDWAC members stated that they would like to provide EPA with 
additional advice on public notification. To follow up on this request, 
EPA met with several NDWAC members on July 1, 2009, to review and 
discuss the current TCR public notification requirements, the advisory 
committee's recommendations on revisions to the public notification 
requirements, and to obtain feedback from NDWAC members. At this 
meeting, NDWAC members discussed potential changes to health effects 
language. They noted that while some portions of the health effects 
language would still be appropriate under the proposed RTCR, some 
changes or additions may be appropriate. Potential inclusions include 
the use of two different types of Tier 2 public notice to account for 
the difference between failure to conduct assessments and failure to 
complete corrective actions, as well as language concerning customer 
actions in response to violations (such as boiling water before use), 
and a change in the description of health effects of coliform exposure 
by sensitive subpopulations. They also recommended that EPA look at the 
public notification requirements for the GWR as they may also be 
appropriate for the proposed RTCR. EPA considered the recommendations 
from NDWAC in developing the public notification requirements for the 
proposed rule and is requesting comment on these issues (see section 
III.A.7.c of this preamble).
    EPA completed its consultation with the US Department of Health and 
Human Services on October 5, 2009, as required by SDWA section 1412(d). 
EPA also provided an informational briefing to the Food and Safety 
Group of the Food and Drug Administration.

L. Impacts on Sensitive Subpopulations as Required by Section 
1412(b)(3)(C)(i) of the 1996 Amendments of the Safe Drinking Water Act 
(SDWA)

    EPA is required to seek public comment regarding the effects of 
contamination associated with the proposed RTCR on the general 
population and sensitive subpopulations. Sensitive subpopulations 
include ``infants, children, pregnant women, the elderly, individuals 
with a history of serious illness, or other subpopulations that are 
identified as likely to be at greater risk of adverse health effects 
due to exposure to contaminants in drinking water than the general 
population'' (SDWA section 1412(b)(3)(C)(i)(V), 42 U.S.C 300g-
1(b)(3)(C)(i)(V)).
    Pregnant and lactating women may be at an increased risk from 
pathogens as well as act as a source of infection for newborns. 
Infection during pregnancy may also result in the transmission of 
infection from the mother to the child in utero, during birth, or 
shortly thereafter. Since very young children do not have fully 
developed immune systems, they are at increased risk and are 
particularly difficult to treat.
    Infectious diseases are also a major problem for the elderly 
because immune function declines with age. As a result, outbreaks of 
waterborne diseases can be devastating on the elderly community (e.g., 
nursing homes) and may increase the possibility of significantly higher 
mortality rates in the elderly than in the general population.
    Immunocompromised individuals are a growing proportion of the 
population with the continued increase in HIV/AIDS, the aging 
population, and the escalation in organ and tissue transplantations. 
Immunocompromised individuals are more susceptible to severe and 
invasive infection. These infections are particularly difficult to 
treat and can result in a significantly higher mortality than in 
immunocompetent persons.
    It is anticipated that the requirements of the proposed RTCR will 
help reduce pathways of entry for fecal contamination and/or waterborne 
pathogens into the distribution system, thereby reducing exposure and 
risk from these contaminants in drinking water to the entire general 
population. The proposed RTCR seeks to provide a similar level of 
drinking water protection to all groups including sensitive 
subpopulations, thus meeting the intent of this Federal policy.

M. Plain Language

    Executive Order 12866 requires each agency to write its rules in 
plain language. Readable regulations help the public find requirements 
quickly and understand them easily. Readable regulations may also 
increase compliance, strengthen enforcement, and decrease mistakes, 
frustration, phone calls, appeals, and distrust of government. EPA has 
made every effort to write this preamble to the proposed rule in as 
clear, concise, and unambiguous manner as possible. EPA requests 
comments on how to improve rule language to enhance readability and 
make it easier to understand.

VIII. References

Bennett, J. V., S.D. Holmberg, M.F. Rogers, and S.L. Solomon. 1987. 
Infectious and Parasitic Diseases. Closing the Gap: The Burden of 
Unnecessary Illness. Eds. R.W. Amler & H.B Dull. Oxford University 
Press, New York. 102-114.
Berlin, L.E., M.L. Rorabaugh, F. Heldrich, K. Roberts, T. Doran, and 
J.F. Modlin. 1993. Aseptic meningitis in infants < 2 years of age: 
diagnosis and etiology. J. Infect. Dis. 168:888-892.
Carey, C.M., H. Lee, and J.T. Trevors. 2004. Biology, persistence 
and detection of Cryptosporidium parvum and Cryptosporidium hominis 
oocyst. Wat. Res. 38: 818-862.
CDC. (Centers for Disease Control and Prevention). 1996. Morbidity 
and Mortality Weekly Report. April 12, 1996. Surveillance for 
Waterborne-Disease Outbreaks--United States, 1993-1994.
CDC. 1997. Paralytic Poliomyelitis United States, 1980-1994. 
Morbidity and

[[Page 40999]]

Mortality Weekly Report Weekly. 46(04):79-83. Available online at 
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, R.M., E.E. Geldreich, K.R. Fox, E.W. Rice, C.H. Johnson, J.A. 
Goodrich, J.A. Barnick, and F. Abdesaken. 1996. Tracking a 
Salmonella serovar typhimurium outbreak in Gideon, Missouri: role of 
contaminant propagation modeling. J. Water SRT-Aqua. 45(4): 171-183.
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).
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.
Falco, R. and S.I. Israel. 2009. Waterborne Salmonella Outbreak in 
Alamosa Colorado March and April 2008: Outbreak Identification, 
Response, and Investigation. Report. Colorado Department of Public 
Health and Environment. November 2009. 64 pp. and appendices. 
Available online at http://www.cdphe.state.co.us/wq/drinkingwater/
AlamosaOutbreak.html.
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.
Kaper, J.B, J.P. Nataro, H.L.T. Mobley, 2004. Pathogenic Escherichia 
coli. Nature Reviews Microbiology 2:123-140.
Kirmeyer, G.J., L. Kirby, B.M. Murphy, P.F. Noran, K.D. Martel, T.W. 
Lund, J.L. Anderson, and R. Medhurst. 1999. Maintaining Water 
Quality in Finished Water Storage Facilities. AWWA and AWWARF. 
Denver, CO. 324 pp.
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.
Lieberman, R.J., Shadix, L.C., Newport, B.S., Crout, S.R., Buescher, 
S.E., Safferman, R.S., Stetler, R.E., Lye, D., Fout, G.S., and 
Dahling, D. 1994. Source water microbial quality of some vulnerable 
public ground water supplies. In: Proceedings, Water Quality 
Technology Conference. San Francisco, CA. October, 1994.
Lieberman, R., L. Shadix, B. Newport, and C. Frebis. 2002. Microbial 
Monitoring of Vulnerable Public Groundwater Supplies. American Water 
Works Association Research Foundation, Denver, CO. 162 pp.
Livernois, J. 2002. The Economic Costs of the Walkerton Crisis. The 
Walkerton Inquiry. Commissioned Paper 14. Toronto: Ontario Ministry 
of the Attorney General. 62 pp.
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.
NRC (National Research Council). 1997. Safe Water from Every Tap: 
Improving Water Service to Small Communities. National Academy 
Press. Washington, DC. pp. 28-47.
NRC. 2006. Drinking Water Distribution Systems, Assessing and 
Reducing Risks. National Academy Press. Washington, DC. pp. 356-357.

[[Page 41000]]

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.
Ogg, J.E., R.A. Ryder, and H.L. Smith. 1989. Isolation of Vibrio 
cholerae from Aquatic Birds in Colorado and Utah. Applied and 
Environmental Microbiology. 55(1):95-99.
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.
Rice, Eugene W. 2009. Memo to Jennifer Best, USEPA Office of 
Groundwater and Drinking Water, Standard Methods for the Examination 
of Water and Wastewater, Sections 9221 D, F and 9222G, July 13, 
2009.
Rice, E. W., C. H. Johnson, M. E. Dunnigan, and D. J. Reasoner. 
1993. Rapid Glutamate Decarboxylase Assay for Detection of 
Escherichia coli. Applied and Environmental Microbiology. 59:4347-
4349.
Rice, E. W., K. R. Fox, H. D. Nash, E. J. Read, and A. P. Smith. 
1987. Comparison of Media for Recovery of Total Coliform Bacteria 
from Chemically Treated Water. Applied and Environmental 
Microbiology. 53:1571-1573.
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.
SBAR Panel (Small Business Advocacy Review Panel). 2008. Small 
Business Advocacy Review Panel on EPA Planned Revisions to Public 
Water System Requirements: Revisions to the Total Coliform 
Monitoring and Analytical Requirements and Consideration of 
Distribution System Issues. Final Report. March 31, 2008.
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.
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. 1998c. Revisions to State Primacy Requirements to Implement 
Safe Drinking Water Act Amendments; Final Rule. 63 FR 23361. (April 
28, 1998).
USEPA. 1999. Drinking Water Criteria Document for Enteroviruses and 
Hepatitis A: An Addendum. January 15, 1999. EPA-822-R-98-043.
USEPA. 2000a. An SAB Report on EPA's White Paper Valuing the 
Benefits of Fatal Cancer Risk Reduction. Prepared for the 
Environmental Economics Advisory Committee. July 27, 2000. EPA-SAB-
EEAC-00-013.
USEPA. 2000b. Stage 2 Microbial and Disinfection Byproducts Federal 
Advisory Committee Agreement in Principle. 65 FR 83015. (December 
29, 2000).
USEPA. 2000c. Guidelines for Preparing Economic Analyses. US EPA 
Office of the Administrator. September 2000. EPA-240-R-00-003.
USEPA. 2000d. Health Risks of Enteric Viral Infections in Children. 
Office of Science and Technology, Washington, DC September 30, 2000. 
EPA-822-R-00-010.
USEPA. 2002. National Primary Drinking Water Regulations: Long Term 
1 Enhanced Surface Water Treatment Rule; Final Rule. 67 FR 1812. 
(January 14, 2002).
USEPA. 2003. National Primary Drinking Water Regulations: 
Announcement of Completion of EPA's Review of Existing Drinking 
Water Standards. 68 FR 42908. (July 18, 2003).
USEPA. 2004. EPA Microbiological Alternate Test Procedure (ATP) 
Protocol for Drinking Water, Ambient Water, and Wastewater 
Monitoring Methods, Guidance. EPA 821-B-03-004.
USEPA. 2005. Manual for the Certification of Laboratories Analyzing 
Drinking Water 5th Edition. Office of Water. January 2005. EPA 815-
R-05-004.
USEPA. 2006a. Economic Analysis for the Final Ground Water Rule. 
October 2006. EPA-815-R-06.014.
USEPA. 2006b. Information Collection Request for Contaminant 
Occurrence Data in Support of EPA's Second 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. 2008a. Draft Information Collection Request for the Microbial 
Rules. OMB Control Number: 2040-0205. EPA Tracking Number: 1895.06. 
September 2008.
USEPA. 2008b. Draft Information Collection Request for the Public 
Water System Supervision Program. OMB Control Number: 2040-0090. EPA 
Tracking Number: 0270.43.
USEPA. 2008c. US Environmental Protection Agency Total Coliform 
Rule/Distribution Systems (TCRDS) Federal Advisory Committee 
Agreement In Principle. Available online at http://www.epa.gov//
safewater/disinfection/tcr/pdfs/tcrdsac/agreementinprinciple_
tcrdsac_2008-09-18.pdf. Accessed on June 2009.
USEPA. 2009. National Primary Drinking Water Regulations: Airline 
Drinking Water Rule; Final Rule. 74 FR 53590. (October 19, 2009).
USEPA 2010a. Economic Analysis for the Proposed Revised Total 
Coliform Rule. EPA-815-R-10-001.
USEPA. 2010b. Technology and Cost Document for the Proposed Revised 
Total Coliform Rule. EPA-815-R-10-002.
USEPA. 2010c. Total Coliform Rule Compliance Monitoring Data Quality 
and Completion Report. EPA-815-R-10-003.
USEPA. 2010d. Information Collection Request for the Proposed 
Revised Total

[[Page 41001]]

Coliform Rule. OMB Control No. 2040-AD94. EPA ICR No. 1895.06.
USEPA. 2010e. Six-Year Review 2 Contaminant Occurrence Data for the 
Proposed RTCR. Available by request at http://www.regulations.gov/as 
part of the Proposed RTCR docket EPA-HQ-OW-2008-0878.
USEPA and WRF. 2009. Memorandum of Understanding on the Total 
Coliform Rule/Distribution System Research and Information 
Collection Partnership Between the US Environmental Protection 
Agency and the Water Research Foundation (WRF). January 27, 2009.
van der Kooij, D. 2003. Managing regrowth in drinking water 
distribution systems. In: Heterotrophic Plate Counts and Drinking-
water Safety, The Significance of HPCs for Water Quality and Human 
Health. J.V. Cotruvo, M. Exner, C. Fricker, and A. Glasmacher. eds. 
London. IWA Publishing. pp.199-232.
Warren, L. S., R. E. Benoit, and J. A. Jessee. 1978. Rapid 
Enumeration of Fecal Coliforms in Water by a Colorimetric B-
Galactosidase Assay. Applied and Environmental Microbiology 
35(1):136-141.

List of Subjects

40 CFR Part 141

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

40 CFR Part 142

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

    Dated: June 16, 2010.
Lisa P. Jackson,
Administrator.

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

PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS

    1. The authority citation for part 141 continues to read as 
follows:

     Authority:  42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 
300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.

    2. Section 141.4 is revised to read as follows:

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 [DATE THREE YEARS FOLLOWING 
PUBLICATION OF THE FINAL RULE], at which time the total coliform MCL is 
no longer effective.

Sec.  141.13  [Removed and reserved]

    3. Section 141.13 is removed and reserved.
    4. Section 141.21 is amended by adding paragraph (h) to read as 
follows:

Sec.  141.21  Coliform sampling.

* * * * *
    (h) The provisions of paragraphs (a) and (d) are applicable until 
[DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE]. The 
provisions of paragraphs (b), (c), (e), (f), and (g) are applicable 
until all required repeat monitoring under paragraph (b) and fecal 
coliform or E. coli testing under paragraph (e) that was initiated by a 
total coliform-positive sample taken before [DATE THREE YEARS FOLLOWING 
PUBLICATION OF THE FINAL RULE] is completed, as well as analytical 
method, reporting, recordkeeping, public notification, and consumer 
confidence report requirements associated with that monitoring and 
testing. After [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL 
RULE], the provisions of subpart Y of this part are applicable, with 
systems required to begin regular monitoring at the same frequency as 
the frequency required on [DATE THREE YEARS FOLLOWING PUBLICATION OF 
THE FINAL RULE].

Sec.  141.22  [Removed and reserved]

    5. Section 141.22 is removed and reserved.
    6. 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 [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL 
RULE]. The MCLG identified in paragraph (a)(6) of this section is 
applicable beginning [DATE THREE YEARS FOLLOWING PUBLICATION OF THE 
FINAL RULE].
    7. Section 141.63 is revised to read as follows:

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

    (a) Until [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL 
RULE], the total coliform MCL is based on the presence or absence of 
total coliforms in a sample, rather than coliform density.
    (1) For a system that collects at least 40 samples per month, if no 
more than 5.0 percent of the samples collected during a month are total 
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 [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL 
RULE], any fecal coliform-positive repeat sample or E. coli-positive 
repeat sample, or any total coliform-positive repeat sample following a 
fecal coliform-positive or E. coli-positive routine sample, constitutes 
a violation of the MCL for total coliforms. For purposes of the public 
notification requirements in subpart Q of this part, this is a 
violation that may pose an acute risk to health.
    (c) Beginning [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL 
RULE], a system is in compliance with the MCL for E. coli for samples 
taken under the provisions of subpart Y of this part unless any of the 
conditions identified in paragraphs (c)(1) through (c)(4) of this 
section occur. For purposes of the public notification requirements in 
subpart Q of this part, violation of the MCL may pose an acute risk to 
health.
    (1) The system has an E. coli-positive repeat sample following a 
total coliform-positive routine sample.

[[Page 41002]]

    (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 [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL 
RULE], a public water system must determine compliance with the MCL for 
total coliforms in paragraphs (a) and (b) of this section for each 
month in which it is required to monitor for total coliforms. Beginning 
[DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], a public 
water system must determine compliance with the MCL for E. coli in 
paragraph (c) of this section for each month in which it is required to 
monitor for total coliforms.
    (e) The Administrator, pursuant to section 1412 of the Act, hereby 
identifies the following as the best technology, treatment techniques, 
or other means available for achieving compliance with the maximum 
contaminant level for total coliforms in paragraphs (a) and (b) of this 
section and for achieving compliance with the maximum contaminant level 
for E. coli in paragraph (c) of this section:
    (1) Protection of wells from fecal contamination by appropriate 
placement and construction;
    (2) Maintenance of a disinfectant residual throughout the 
distribution system;
    (3) Proper maintenance of the distribution system including 
appropriate pipe replacement and repair procedures, main flushing 
programs, proper operation and maintenance of storage tanks and 
reservoirs, cross connection control, and continual maintenance of 
positive water pressure in all parts of the distribution system;
    (4) Filtration and/or disinfection of surface water, as described 
in subparts H, P, T, and W of this part, or disinfection of ground 
water, as described in subpart S of this part, using strong oxidants 
such as chlorine, chlorine dioxide, or ozone; and
    (5) For systems using ground water, compliance with the 
requirements of an EPA-approved State Wellhead Protection Program 
developed and implemented under section 1428 of the SDWA.
    8. Section 141.74 is amended by revising paragraphs (b)(6)(i) and 
(c)(3)(i) to read as follows:

Sec.  141.74  Analytical and monitoring requirements.

* * * * *
    (b) * * *
    (6)(i) Until [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL 
RULE], the residual disinfectant concentration must be measured at 
least at the same points in the distribution system and at the same 
time as total coliforms are sampled, as specified in Sec.  141.21. 
Beginning [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], 
the residual disinfectant concentration must be measured at least at 
the same points in the distribution system and at the same time as 
total coliforms are sampled, as specified in Sec. Sec.  141.854 through 
141.857. The State may allow a public water system which uses both a 
surface water source or a ground water source under direct influence of 
surface water, and a ground water source, to take disinfectant residual 
samples at points other than the total coliform sampling points if the 
State determines that such points are more representative of treated 
(disinfected) water quality within the distribution system. 
Heterotrophic bacteria, measured as heterotrophic plate count (HPC) as 
specified in paragraph (a)(1) of this section, may be measured in lieu 
of residual disinfectant concentration.
* * * * *
    (c) * * *
    (3)(i) The residual disinfectant concentration must be measured at 
least at the same points in the distribution system and at the same 
time as total coliforms are sampled, as specified in Sec.  141.21, and 
as specified in Sec. Sec.  141.854 through 141.857 beginning [DATE 
THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], except that the 
State may allow a public water system which uses both a surface water 
source or a ground water source under direct influence of surface 
water, and a ground water source, to take disinfectant residual samples 
at points other than the total coliform sampling points if the State 
determines that such points are more representative of treated 
(disinfected) water quality within the distribution system. 
Heterotrophic bacteria, measured as heterotrophic plate count (HPC) as 
specified in paragraph (a)(1) of this section, may be measured in lieu 
of residual disinfectant concentration.
* * * * *
    9. Section 141.132 is amended by revising paragraph (c)(1)(i) to 
read as follows:

Sec.  141.132  Monitoring requirements.

* * * * *
    (c) * * *
    (1) * * *
    (i) Routine monitoring. Until [DATE THREE YEARS FOLLOWING 
PUBLICATION OF THE FINAL RULE], community and non-transient non-
community water systems that use chlorine or chloramines must measure 
the residual disinfectant level in the distribution system at the same 
point in the distribution system and at the same time as total 
coliforms are sampled, as specified in Sec.  141.21. Beginning [DATE 
THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], community and 
non-transient non-community water systems that use chlorine or 
chloramines must measure the residual disinfectant level in the 
distribution system at the same point in the distribution system and at 
the same time as total coliforms are sampled, as specified in 
Sec. Sec.  141.854 through 141.857. 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.
* * * * *
    10. Section 141.153 is amended as follows:
    (a) By revising paragraph (d)(4)(vii) introductory text.
    (b) By revising paragraph (d)(4)(viii).
    (c) By adding paragraphs (d)(4)(x) and (d)(4)(xi).

Sec.  141.153  Content of the reports.

* * * * *
    (d) * * *
    (4) * * *
    (vii) For total coliform analytical results until [DATE THREE YEARS 
FOLLOWING PUBLICATION OF THE FINAL RULE]:
* * * * *
    (viii) For fecal coliform until [DATE THREE YEARS FOLLOWING 
PUBLICATION OF THE FINAL RULE]: The total number of positive samples;
* * * * *
    (x) For total coliform taken under subpart Y:
    (A) The number of Level 1 and Level 2 assessments required and 
completed; and
    (B) The corrective actions required and completed; and
    (xi) For E. coli: The total number of positive samples.
* * * * *
    11. In Appendix A to Subpart O of Part 141, the table is amended by 
revising the entries for ``Total Coliform Bacteria'' and ``Fecal 
Coliform and E. coli,'' adding a second entry for ``Total

[[Page 41003]]

Coliform Bacteria,'' adding as a fourth entry ``E. coli,'' and adding 
two endnotes, to read as follows:

                                               Appendix A to Subpart O of Part 141--Regulated Contaminants
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      To convert
    Contaminant  (units)      Traditional MCL in mg/   for CCR,      MCL in CCR units        MCLG      Major sources in drinking       Health effects
                                        L            multiply by                                                 water                    language
--------------------------------------------------------------------------------------------------------------------------------------------------------
Microbiological
 contaminants:
    Total Coliform            MCL (systems that      ...........  MCL (systems that                0  Naturally present in the     Coliforms are
     Bacteria.[dagger].        collect >= 40                       collect >= 40                       environment.                 bacteria that are
                               samples/month) 5% of                samples/month) 5% of                                             naturally present in
                               monthly samples are                 monthly samples are                                              the environment and
                               positive; (systems                  positive; (systems                                               are used as an
                               that collect < 40                   that collect < 40                                                indicator that
                               samples/month) 1                    samples/month) 1                                                 other, potentially-
                               positive monthly                    positive monthly                                                 harmful, bacteria
                               sample.                             sample.                                                          may be present.
                                                                                                                                    Coliforms were found
                                                                                                                                    in more samples than
                                                                                                                                    allowed and this was
                                                                                                                                    a warning of
                                                                                                                                    potential problems.
    Total Coliform Bacteria   TT...................  ...........  TT...................          N/A  Naturally present in the     Coliforms are
     [Dagger].                                                                                         environment.                 bacteria that are
                                                                                                                                    naturally present in
                                                                                                                                    the environment and
                                                                                                                                    are used as an
                                                                                                                                    indicator that
                                                                                                                                    other, potentially
                                                                                                                                    harmful, bacteria
                                                                                                                                    may be present. The
                                                                                                                                    water system found
                                                                                                                                    coliforms indicating
                                                                                                                                    the need to look for
                                                                                                                                    potential problems
                                                                                                                                    in water treatment
                                                                                                                                    or distribution.
                                                                                                                                    When this occurs,
                                                                                                                                    public water systems
                                                                                                                                    are required to
                                                                                                                                    conduct assessments
                                                                                                                                    to identify problems
                                                                                                                                    and to correct any
                                                                                                                                    problems that are
                                                                                                                                    found. [THE SYSTEM
                                                                                                                                    MUST USE THE
                                                                                                                                    FOLLOWING APPLICABLE
                                                                                                                                    SENTENCES.] The
                                                                                                                                    water system failed
                                                                                                                                    to conduct the
                                                                                                                                    required
                                                                                                                                    assessment(s). The
                                                                                                                                    water system failed
                                                                                                                                    to correct all
                                                                                                                                    identified sanitary
                                                                                                                                    defects.
    Fecal coliform and E.     0....................  ...........  0....................            0  Human and animal fecal       Fecal coliforms and
     coli [dagger].                                                                                    waste.                       E. coli are bacteria
                                                                                                                                    whose presence
                                                                                                                                    indicates that the
                                                                                                                                    water may be
                                                                                                                                    contaminated with
                                                                                                                                    human or animal
                                                                                                                                    wastes. Microbes in
                                                                                                                                    these wastes can
                                                                                                                                    cause short-term
                                                                                                                                    effects, such as
                                                                                                                                    diarrhea, cramps,
                                                                                                                                    nausea, headaches,
                                                                                                                                    or other symptoms.
                                                                                                                                    They may pose a
                                                                                                                                    special health risk
                                                                                                                                    for infants, young
                                                                                                                                    children, some of
                                                                                                                                    the elderly, and
                                                                                                                                    people with severely
                                                                                                                                    compromised immune
                                                                                                                                    systems.
    E. coli [Dagger]........  Routine and repeat     ...........  In compliance unless             0  Human and animal fecal       E. coli are bacteria
                               samples are total                   one of the following                waste.                       whose presence
                               coliform-positive                   conditions occurs:                                               indicates that the
                               and either is E.                   (1) The system has an                                             water may be
                               coli-positive or                    E. coli-positive                                                 contaminated with
                               system fails to take                repeat sample                                                    human or animal
                               repeat samples                      following a total                                                wastes. Microbes in
                               following E. coli-                  coliform-positive                                                these wastes can
                               positive routine                    routine sample.                                                  cause short-term
                               sample or system                   (2) The system has a                                              effects, such as
                               fails to analyze                    total coliform-                                                  diarrhea, cramps,
                               total coliform-                     positive repeat                                                  nausea, headaches,
                               positive repeat                     sample following an                                              or other symptoms.
                               sample for E. coli.                 E. coli-positive                                                 They may pose a
                                                                   routine sample.                                                  greater health risk
                                                                  (3) The system fails                                              for infants, young
                                                                   to take all required                                             children, some of
                                                                   repeat samples                                                   the elderly, and
                                                                   following an E. coli-                                            people with severely-
                                                                   positive routine                                                 compromised immune
                                                                   sample.                                                          systems.
                                                                  (4) The system fails
                                                                   to test for E. coli
                                                                   when any repeat
                                                                   sample tests
                                                                   positive for total
                                                                   coliform.

[[Page 41004]]

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
[dagger] Until [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE].
[Dagger] Beginning [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE].

* * * * *

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

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));

                              * * * * * * *
------------------------------------------------------------------------

    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.
* * * * *
    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 violations under subpart Y of 40 CFR part 141.
------------------------------------------------------------------------

* * * * *
    15. Appendix A to subpart Q of Part 141 is amended by revising 
entries I.A.1 and I.A.2 and adding two endnotes to read as follows:

     Appendix A to Subpart Q of Part 141--NPDWR Violations and Other Situations Requiring Public Notice \1\
----------------------------------------------------------------------------------------------------------------
                                                  MCL/MRDL/TT violations \2\         Monitoring, testing and
                                               --------------------------------  reporting procedure  violations
                                                                               ---------------------------------
                  Contaminant                   Tier of public                  Tier of public
                                                    notice         Citation         notice          Citation
                                                   required                        required
----------------------------------------------------------------------------------------------------------------
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 (TT violations                        2      141.860(b)               3        141.860(c)
     resulting from failure to perform
     assessments or corrective actions)
     [Dagger].................................
    2.a Fecal coliform/E. coli [dagger].......               1       141.63(b)             1,3         141.21(e)
    2.b E. coli [Dagger]......................               1       141.63(c)               3     141.860(d)(2)

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Appendix A--Endnotes
[dagger] Until [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE].

[[Page 41005]]

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

* * * * *
    16. Appendix B to subpart Q of Part 141 is amended as follows:
    (a) By revising entries 1a and 1b.
    (b) By adding entries 1e and 1f.
    (c) By adding two endnotes.

         Appendix B to Subpart Q of Part 141--Standards Health Effects Language for Public Notification
----------------------------------------------------------------------------------------------------------------
                                                                               Standard health effects language
           Contaminant                 MCLG;\1\ mg/L         MCL\2\ mg/L            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.              Zero................  Zero...............  Fecal coliforms and E. coli are
 coli.[dagger].                                                                bacteria whose presence indicates
                                                                               that the water may be
                                                                               contaminated with human or animal
                                                                               wastes. Microbes in these wastes
                                                                               can cause short-term effects,
                                                                               such as diarrhea, cramps, nausea,
                                                                               headaches, or other symptoms.
                                                                               They may pose a special health
                                                                               risk for infants, young children,
                                                                               some of the elderly, and people
                                                                               with severely compromised immune
                                                                               systems.

                                                  * * * * * * *
1e. Subpart Y Coliform Assessment  N/A.................  TT \3\.............  Coliforms are bacteria that are
 and/or Corrective Action                                                      naturally present in the
 Violations.[Dagger].                                                          environment and are used as an
                                                                               indicator that other, potentially
                                                                               harmful, bacteria may be present.
                                                                               The water system found coliforms
                                                                               indicating the need to look for
                                                                               potential problems in water
                                                                               treatment or distribution. When
                                                                               this occurs, public water systems
                                                                               are required to conduct
                                                                               assessments to identify problems
                                                                               and to correct any problems that
                                                                               are found.
                                                                              [THE SYSTEM MUST USE THE FOLLOWING
                                                                               APPLICABLE SENTENCES.]
                                                                              The water system failed to conduct
                                                                               the required assessment.
                                                                              The water system failed to correct
                                                                               all identified sanitary defects.
1f. E. coli [Dagger].............  Zero................  In compliance        E. coli are bacteria whose
                                                          unless one of the    presence indicates that the water
                                                          following            may be contaminated with human or
                                                          conditions occurs:   animal wastes. Microbes in these
                                                         (1) The system has    wastes can cause short-term
                                                          an E. coli-          effects, such as diarrhea,
                                                          positive repeat      cramps, nausea, headaches, or
                                                          sample following a   other symptoms. They may pose a
                                                          total coliform-      greater health risk for infants,
                                                          positive routine     young children, some of the
                                                          sample.              elderly, and people with severely
                                                         (2) The system has    compromised immune systems.
                                                          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.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Appendix B--Endnotes
[dagger] Until [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE].
[Dagger] Beginning [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE].

* * * * *
    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

[[Page 41006]]

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 [DATE THREE YEARS FOLLOWING PUBLICATION OF 
THE FINAL RULE], 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 beginning [DATE THREE 
YEARS FOLLOWING PUBLICATION OF THE FINAL RULE].
    (2) Sampling requirements. A ground water system must collect, 
within 24 hours of notification of the total coliform-positive sample, 
at least one ground water source sample from each ground water source 
in use at the time the total coliform-positive sample was collected 
under Sec.  141.21(a) until [DATE THREE YEARS FOLLOWING PUBLICATION OF 
THE FINAL RULE], or collected under Sec. Sec.  141.854 through 141.857 
beginning [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], 
except as provided in paragraph (a)(2)(ii) of this section.
    (i) The State may extend the 24-hour time limit on a case-by-case 
basis if the system cannot collect the ground water source water sample 
within 24 hours due to circumstances beyond its control. In the case of 
an extension, the State must specify how much time the system has to 
collect the sample.
    (ii) If approved by the State, systems with more than one ground 
water source may meet the requirements of this paragraph (a)(2) by 
sampling a representative ground water source or sources. If directed 
by the State, systems must submit for State approval a triggered source 
water monitoring plan that identifies one or more ground water sources 
that are representative of each monitoring site in the system's sample 
siting plan under Sec.  141.21(a) until [DATE THREE YEARS FOLLOWING 
PUBLICATION OF THE FINAL RULE], or under Sec.  141.853 beginning [DATE 
THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], and that the 
system intends to use for representative sampling under this paragraph.
    (iii) Until [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL 
RULE], a ground water system serving 1,000 or fewer people may use a 
repeat sample collected from a ground water source to meet both the 
requirements of 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 [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL 
RULE], a ground water system serving 1,000 or fewer people may use a 
repeat sample collected from a ground water source to meet both the 
requirements of subpart Y and to satisfy the monitoring requirements of 
paragraph (a)(2) of this section for that ground water source only if 
the State approves the use of E. coli as a fecal indicator for source 
water monitoring under this paragraph (a) and approves the use of a 
single sample for meeting both the triggered source water monitoring 
requirements in this paragraph (a) and the repeat monitoring 
requirements in 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 [DATE THREE YEARS 
FOLLOWING PUBLICATION OF THE FINAL RULE], or under Sec. Sec.  141.854 
through 141.857 beginning [DATE THREE YEARS FOLLOWING PUBLICATION OF 
THE FINAL RULE], must notify the wholesale system(s) within 24 hours of 
being notified of the total 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 [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL 
RULE], or collected under Sec. Sec.  141.854 through 141.857 beginning 
[DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], is total 
coliform-positive must, within 24 hours of being notified, collect a 
sample from its ground water source(s) under paragraph(a)(2) of this 
section and analyze it for a fecal indicator under paragraph (c) of 
this section.
    (B) If the sample collected under paragraph (a)(4)(ii)(A) of this 
section is fecal indicator-positive, the wholesale ground water system 
must notify all consecutive systems served by that ground water source 
of the fecal indicator source water positive within 24 hours of being 
notified of the ground water source sample monitoring result and must 
meet the requirements of paragraph (a)(3) of this section.
    (5) Exceptions to the triggered source water monitoring 
requirements. A ground water system is not required to comply with the 
source water monitoring requirements of paragraph (a) of this section 
if either of the following conditions exists:
    (i) The State determines, and documents in writing, that the total 
coliform-positive sample collected under Sec.  141.21(a) until [DATE 
THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], or under 
Sec. Sec.  141.854 through 141.857 beginning [DATE THREE YEARS 
FOLLOWING PUBLICATION OF THE FINAL RULE], is caused by a distribution 
system deficiency; or
    (ii) The total coliform-positive sample collected under Sec.  
141.21(a) until [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL 
RULE], or under Sec. Sec.  141.854 through 141.857 beginning [DATE 
THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], is collected at a 
location that meets State criteria for distribution system conditions 
that will cause total coliform-positive samples.
* * * * *
    18. Section 141.405 is amended by revising paragraph (b)(4) to read 
as follows:

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 [DATE THREE YEARS FOLLOWING 
PUBLICATION OF THE FINAL RULE], or under Sec.  141.853 beginning [DATE 
THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE]. Documentation

[[Page 41007]]

shall be kept for a period of not less than five years.
* * * * *
    19. Section 141.803 is amended by revising paragraphs (a)(3) and 
(a)(5) to read as follows:

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. Sec.  
141.21(f)(3) and 141.21(f)(6) until [DATE THREE YEARS FOLLOWING 
PUBLICATION OF THE FINAL RULE], and under Sec.  141.852 beginning [DATE 
THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE].
* * * * *
    (5) The invalidation of a total coliform sample result can be made 
only by the Administrator in accordance with Sec. Sec.  
141.21(c)(1)(i), (ii), or (iii) or by the certified laboratory in 
accordance with Sec.  141.21(c)(2) until [DATE THREE YEARS FOLLOWING 
PUBLICATION OF THE FINAL RULE], or in accordance with Sec.  141.853(c) 
beginning [DATE THREE YEARS FOLLOWING PUBLICATION OF THE FINAL RULE], 
with the Administrator acting as the State.
* * * * *
    20. Part 141 is amended by adding a new subpart Y to read as 
follows:
Subpart Y--Revised Total Coliform Rule
Sec.
141.850 General.
141.851 Definitions.
141.852 Analytical methods and laboratory certification.
141.853 General monitoring requirements for all public water 
systems.
141.854 Routine monitoring requirements for non-community water 
systems serving 1,000 or fewer people using only ground water.
141.855 Routine monitoring requirements for community water systems 
serving 1,000 or fewer people using only ground water.
141.856 Routine monitoring requirements for subpart H public water 
systems of this part serving 1,000 or fewer people.
141.857 Routine monitoring requirements for public water systems 
serving more than 1,000 people.
141.858 Repeat monitoring and E. coli requirements.
141.859 Coliform treatment technique requirements for protection 
against potential fecal contamination.
141.860 Violations.
141.861 Reporting and recordkeeping.

Subpart Y--Revised Total Coliform Rule

Sec.  141.850  General.

    (a) General. The provisions of this subpart include both maximum 
contaminant level and treatment technique requirements.
    (b) Applicability. The provisions of this subpart apply to all 
public water systems.
    (c) Compliance date. Systems must comply with the provisions of 
this subpart beginning [DATE THREE YEARS FOLLOWING PUBLICATION OF THE 
FINAL RULE], unless otherwise specified in this subpart.

Sec.  141.851  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 treatment technique 
trigger exceedances or treatment technique violations under subpart Y.
    Sanitary defect is a defect that could provide a pathway of entry 
for microbial contamination into the distribution system or that is 
indicative of a failure or imminent failure in a barrier that is 
already in place.
    Seasonal system is a non-community water system that is operated in 
three or fewer calendar quarters per calendar year.

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 of either is not 
required.
    (3) The time from sample collection to initiation of test medium 
incubation may not exceed 30 hours. Systems are encouraged but not 
required to hold samples below 10 deg. C during transit.
    (4) If chlorinated water is to be analyzed, sufficient sodium 
thiosulfate (Na2S2O3) must be added to 
the sample bottle before sterilization to neutralize any residual 
chlorine in the water sample. Dechlorination procedures are addressed 
in Section 9060A.2 of Standard Methods for the Examination of Water and 
Wastewater (20th and 21st editions).
    (5) Systems must conduct total coliform analyses in accordance with 
one of the analytical methods in the following table or one of the 
alternative methods listed in Appendix A to subpart C of part 141.

----------------------------------------------------------------------------------------------------------------
             Organism                  Methodology category             Method \1\                Citation
----------------------------------------------------------------------------------------------------------------
Total Coliforms...................  Lactose Fermentation        Total Coliform Multiple     9221 B.1, B.2 \1\
                                     Methods.                    Tube Fermentation           \2\
                                                                 Technique.
                                                                Presence-Absence (P-A)      9221 D.1, D.2 \1\
                                                                 Coliform Test.              \12\
                                    Membrane Filtration         Total Coliform Membrane     9222 B, C \1\ \3\
                                     Methods.                    Filter Technique.
                                                                Membrane Filtration using   EPA Method 1604 \3\
                                                                 MI medium.                  \4\
                                                                m-ColiBlue24[supreg]
                                                                 Test.\3\ \5\
                                                                Chromocult.\3\ \6\
                                    Enzyme Substrate Methods..  Colilert[supreg]..........  9223 B \1\ \7\
                                                                Colisure[supreg]..........  9223 B \1, 7, 8\
                                                                E*Colite[supreg] Test.\9\
                                                                Readycult[supreg]
                                                                 Test.\10\
                                                                modified Colitag[supreg]
                                                                 Test.\11\
Escherichia coli..................  Escherichia coli Procedure  EC-MUG medium.............  9221 F.1 \1\
                                     (following Lactose
                                     Fermentation Methods).
                                    Escherichia coli Partition  EC broth with MUG (EC-MUG)  9222 G.1a(2) \1\
                                     Method.                                                 \13\
                                                                NA-MUG medium.............  9222 G.1a(1) \1\
                                    Membrane Filtration         Membrane Filtration using   EPA Method 1604 \3\
                                     Methods.                    MI medium.                  \4\
                                                                m-ColiBlue24[supreg]
                                                                 Test.\3\ \5\
                                                                Chromocult.\3\ \6\
                                    Enzyme Substrate Methods..  Colilert[supreg]..........  9223 B \1\ \7\
                                                                Colisure[supreg]..........  9223 B \1\ \7\ \8\
                                                                E*Colite[supreg] Test.\9\
                                                                Readycult[supreg]
                                                                 Test.\10\

[[Page 41008]]

                                                                modified Colitag[supreg]
                                                                 Test.\11\
----------------------------------------------------------------------------------------------------------------
The procedures must be done in accordance with the documents listed below. For vendor methods, the date of the
  method listed here is the date/version of the approved method. The methods listed are the only versions that
  may be used for compliance with this rule. Laboratories should be careful to use only the approved versions of
  the methods, as product package inserts may not be the same as the approved versions of the methods.
The Director of the Federal Register approved the incorporation by reference of the documents listed in
  footnotes 1, 4, 5, 6, 9, 10, and 11 in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51.
Copies of the documents may be obtained from the sources listed below. Information regarding these documents can
  be obtained from the Safe Drinking Water Hotline, telephone (800) 426-4791. Documents may be reviewed at EPA's
  Drinking Water Docket, EPA West, 1301 Constitution Avenue, NW., EPA West, Room B102, Washington, DC 20460
  (Telephone: 202-566-2426); or at the National Archives and Records Administration (NARA). For information on
  the availability of this material at NARA, call (202) 741-6030, or go to: http://www.archives.gov/federal-
  register/cfr/ibr-locations.html.
\1\ Methods are described in Standard Methods for the Examination of Water and Wastewater, 20th edition (1998),
  or 21st edition (2005). American Public Health Association, 800 I Street, NW., Washington, DC 20001. The cited
  methods published in either of these two editions may be used. In addition, the following online versions may
  also be used: 9221 B.1, B.2-99, D.1, D.2-99, 9222 B-97, 9222 C-97, and 9223 B-97. Standard Methods Online is
  available at http://www.standardmethods.org. The year in which each method was approved by the Standard
  Methods Committee is designated by the last two digits following the hyphen in the method number. The methods
  listed are the only online versions that may be used.
\2\ Lactose broth, as commercially available, may be used in lieu of lauryl tryptose broth, if the system
  conducts at least 25 parallel tests between lactose broth and lauryl tryptose broth using the water normally
  tested, and if the findings from this comparison demonstrate that the false-positive rate and false-negative
  rate for total coliforms, using lactose broth, is less than 10 percent.
\3\ All filtration series must begin with membrane filtration equipment that has been sterilized by autoclaving.
  Exposure of filtration equipment to UV light is not adequate to ensure sterilization. Subsequent to the
  initial autoclaving, exposure of the filtration equipment to UV light may be used to sanitize the funnels
  between filtrations within a filtration series.
\4\ EPA Method 1604: Total Coliforms and Escherichia coli in Water by Membrane Filtration Using a Simultaneous
  Detection Technique (MI Medium); September 2002, EPA 821-R-02-024. The method is available at http://
  www.epa.gov/nerlcwww/1604sp02.pdf or from EPA's Water Resource Center (RC-4100T), 1200 Pennsylvania Avenue,
  NW., Washington, DC 20460.
\5\ The m-ColiBlue24[supreg] test is described in the document ``Membrane Filtration Method m-ColiBlue24[supreg]
  Broth, Revision 2, August 17, 1999'', available from the Hach Company, P.O. Box 389, Loveland, CO 80539.
\6\ The Chromocult test is described in the document ``Chromocult[supreg] Coliform Agar Presence/Absence
  Membrane Filter Test Method for Detection and Identification of Coliform Bacteria and Escherichia coli in
  Finished Waters,'' November 2000, Version 1.0, available from EMD Chemicals (an affiliate of Merck KGaA,
  Darmstadt Germany), 480 S. Democrat Road, Gibbstown, NJ 08027-1297. (Telephone (800) 222-0342).
\7\ Multiple-tube and multi-well enumerative formats for this method are approved for use in presence-absence
  determination under this regulation.
\8\ Colisure[supreg] results may be read after an incubation time of 24 hours.
\9\ The E*Colite[supreg] test is described in the document ``Charm E*Colite\TM\ Presence/Absence Test for
  Detection and Identification of Coliform Bacteria and Escherichia coli in Drinking Water'', January 9, 1998,
  available from Charm Sciences, Inc., 659 Andover Street, Lawrence, MA 01843-1032.
\10\ The Readycult[supreg] test is described in the document ``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,'' available from EMD Chemicals (an affiliate of Merck KGaA, Darmstadt Germany), 480 S.
  Democrat Road, Gibbstown, NJ 08027-1297. (Telephone (800) 222-0342). Internet address http://
  www.readycult.com.
\11\ The Colitag[supreg] test is described in the document ``Modified Colitag\TM\ Test Method for the
  Simultaneous Detection of E. coli and other Total Coliforms in Water,'' August 28, 2009, available from CPI
  International, Inc., 5580 Skylane Blvd., Santa Rosa, CA 95403. (Telephone (800) 878-7654, Fax (707) 545-7901).
  Internet address http://www.cpiinternational.com.
\12\ 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.
\13\ 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 
contaminant used for compliance monitoring under this rule.

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 [DATE THREE YEARS AFTER PUBLICATION OF FINAL 
RULE]. Systems must collect total coliform samples according to the 
written sample siting plan. These plans are subject to State review and 
revision. Monitoring required by 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) A system may conduct more monitoring than is required by this 
subpart to investigate potential problems in the distribution system 
and use monitoring as a tool to assist in uncovering problems. A system 
may take more than the minimum number of required routine samples and 
include the results in calculating whether the coliform treatment 
technique trigger has been exceeded only if the samples are taken in 
accordance with the existing sample siting plan and are representative 
of water throughout the distribution system.
    (4) Systems must identify repeat monitoring locations in the sample 
siting plan. Unless the provisions of paragraphs (a)(4)(i) or 
(a)(4)(ii) of this section are met, the system must collect at least 
one repeat sample from the sampling tap where the original total 
coliform-positive sample was taken, and at least one repeat sample at a 
tap within five service connections upstream and at least one repeat 
sample at a tap within five service connections downstream of the 
original sampling site. If a total coliform-positive sample is at the 
end of the distribution system, or one service connection away from the 
end of the distribution system, the State may waive the requirement to 
collect at least one repeat sample upstream or

[[Page 41009]]

downstream of the original sampling site. Except as provided for in 
paragraph (a)(4)(ii) of this section, systems required to conduct 
triggered source water monitoring under 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 as needed.
    (ii) Ground water systems serving 1,000 or fewer people may propose 
repeat sampling locations to the State that differentiate potential 
source water and distribution system contamination (e.g. by sampling at 
entry points to the distribution system). A ground water system 
required to conduct triggered source water monitoring may, with written 
State approval, take one of its repeat samples at the monitoring 
location required for triggered source water monitoring under 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 with a limited number of monitoring 
locations takes more than one repeat sample at the monitoring location 
required for triggered source water monitoring, the system may reduce 
the number of additional source water samples required under 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 with a limited number of monitoring locations 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).
    (5) States may review, revise, and approve, as necessary, repeat 
sampling proposed by systems under paragraphs (a)(4)(i) and (ii) of 
this section. The system must demonstrate to the State's satisfaction 
that the sample siting plan remains representative of the water quality 
in the distribution system. The State may determine that monitoring at 
the entry point to the distribution system (especially for 
undisinfected ground water systems) is effective to differentiate 
between potential source water and distribution system problems.
    (b) Special purpose samples. Special purpose samples, such as those 
taken to determine whether disinfection practices are sufficient 
following pipe placement, replacement, or repair, must not be used to 
determine whether the coliform treatment technique trigger has been 
exceeded. Repeat samples taken pursuant to 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 within five service connections of the original tap 
are total coliform-negative (e.g., a State cannot invalidate a total 
coliform-positive sample on the basis of repeat samples if all the 
repeat samples are total coliform-negative, or if the system has only 
one service connection).
    (iii) The State has substantial grounds to believe that a total 
coliform-positive result is due to a circumstance or condition that 
does not reflect water quality in the distribution system. In this 
case, the system must still collect all repeat samples required under 
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.

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

[[Page 41010]]

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. Systems must monitor 
each calendar quarter that the system provides water to the public, 
except for seasonal systems or as provided under paragraphs (c) though 
(h) and (j) of this section. Seasonal systems must meet the monitoring 
requirements of paragraph (i) of this section.
    (c) Transition to subpart Y. (1) Systems, including seasonal 
systems, must continue to monitor according to the total coliform 
monitoring schedules under Sec.  141.21 that were in effect on [DATE 
THREE YEARS AFTER PUBLICATION OF THE FINAL RULE] unless any of the 
conditions for increased monitoring in paragraph (f) of this section 
are triggered on or after [DATE THREE YEARS AFTER PUBLICATION OF THE 
FINAL RULE] or unless otherwise directed by the State.
    (2) After [DATE THREE YEARS AFTER PUBLICATION OF THE FINAL RULE], 
the State must perform a special monitoring evaluation during each 
sanitary survey to review the status of the system, including the 
distribution system, to determine whether the system is on an 
appropriate monitoring schedule. After the State has performed the 
special monitoring evaluation during each sanitary survey, the State 
may modify the system's monitoring schedule as necessary. For seasonal 
systems on quarterly or annual monitoring, this evaluation must include 
review of the approved sample siting plan, which must designate the 
time period(s) for monitoring based on site-specific considerations 
(e.g. during periods of highest demand or highest vulnerability to 
contamination). The seasonal system must collect compliance samples 
during these time periods.
    (d) Annual site visits. Beginning no later than [DATE FOUR YEARS 
AFTER PUBLICATION OF THE FINAL RULE], systems on annual monitoring, 
including seasonal systems, must have an initial and recurring annual 
site visit by the State or an annual voluntary Level 2 assessment by a 
party approved by the State to remain on annual monitoring.
    (e) Reduced monitoring provisions. Beginning [DATE THREE YEARS 
AFTER PUBLICATION OF THE FINAL RULE], the State may reduce the 
monitoring frequency for a well-operated ground water system from 
quarterly routine monitoring to no less than annual monitoring, if the 
system demonstrates that it meets the criteria for reduced monitoring 
in paragraphs (e)(1) through (e)(3) of this section, except for a 
system that has been on increased monitoring under the provisions of 
paragraph (f) of this section. A system on increased monitoring under 
paragraph (f) of this section must meet the provisions of paragraph (g) 
of this section to go to quarterly monitoring and must meet the 
provisions of paragraph (h) of this section to go to annual monitoring.
    (1) The most recent sanitary survey shows that the system is free 
of sanitary defects, has a protected water source, and meets approved 
construction standards;
    (2) The system has a clean compliance history for a minimum of 12 
months; and
    (3) The State has conducted an annual site visit (recurring) within 
the last 12 months and the system has corrected all identified sanitary 
defects. The system may substitute a Level 2 assessment by a party 
approved by the State for the State annual site visit.
    (f) Increased Monitoring Requirements. A system on quarterly or 
annual monitoring that experiences any of the events identified in 
paragraphs (f)(1) through (f)(4) of this section must begin monthly 
monitoring the month following the event. The system must continue 
monthly monitoring until the requirements in paragraph (g) of this 
section for quarterly monitoring or paragraph (h) of this section for 
annual monitoring are met. A system on monthly monitoring for reasons 
other than those identified in paragraphs (f)(1) through (f)(4) of this 
section is not considered to be on increased monitoring for the 
purposes of paragraphs (g) and (h) of this section.
    (1) The system triggers a Level 2 assessment or two Level 1 
assessments in a rolling 12 month period.
    (2) The system has an E. coli MCL violation.
    (3) The system has a coliform treatment technique violation.
    (4) The system has two subpart Y monitoring violations in a rolling 
12-month period for a system on quarterly monitoring or one subpart Y 
monitoring violation for a system on annual monitoring.
    (g) Requirements for returning to quarterly monitoring. To be 
eligible to return to quarterly monitoring from monthly monitoring 
triggered under paragraph (f) of this section, a system on increased 
monitoring under paragraph (f) of this section must meet the criteria 
in paragraphs (g)(1) and (g)(2) of this section.
    (1) Within the last 12 months, the system must have a completed 
sanitary survey or a site visit by the State or a voluntary Level 2 
assessment by a party approved by the State, be free of sanitary 
defects, and have a protected water source; and
    (2) The system must have a clean compliance history for a minimum 
of 12 months.
    (h) Requirements for annual monitoring. To be eligible for annual 
monitoring, a system on increased monitoring under paragraph (f) of 
this section must meet the criteria in paragraph (g) of this section 
plus the criteria in paragraphs (h)(1) and (h)(2) of this section.
    (1) An annual site visit (recurring) by the State and correction of 
all identified sanitary defects. The system may substitute a voluntary 
Level 2 assessment by a party approved by the State for the State 
annual site visit in any given year.
    (2) The system must have in place or adopt one or more additional 
enhancements to the water system barriers to contamination in 
paragraphs (h)(2)(i) through (h)(2)(v) of this section.
    (i) Cross connection control, as approved by the State.
    (ii) An operator certified by an appropriate State certification 
program, which may include regular visits by a circuit rider.
    (iii) Continuous disinfection entering the distribution system and 
a residual in the distribution system in accordance with criteria 
specified by the State.
    (iv) Demonstration of maintenance of at least a 4-log removal or 
inactivation of viruses as provided for under Sec.  141.403(b)(3).
    (v) Other equivalent enhancements to water system barriers as 
approved by the State.
    (i) Seasonal systems. (1) Beginning [DATE THREE YEARS AFTER 
PUBLICATION OF THE FINAL RULE], all seasonal systems must demonstrate 
completion of a State-approved start-up procedure, which may include a 
requirement for a startup sample prior to serving water to the public.
    (2) Seasonal systems have a routine monitoring frequency of 
monthly.
    (3) A seasonal system must meet the criteria in paragraphs 
(i)(3)(i) through (iii) of this section to be eligible for monitoring 
less frequently than monthly after [DATE THREE YEARS AFTER PUBLICATION 
OF FINAL RULE], except as provided under paragraph (c) of this section.
    (i) The seasonal system must have an approved sample siting plan 
that designates the time period for monitoring based on site-specific

[[Page 41011]]

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

[[Page 41012]]

    (f) Additional routine monitoring. Systems collecting samples on a 
quarterly frequency must conduct additional routine monitoring the 
month following one or more total coliform-positive samples (with or 
without a Level 1 treatment technique trigger). Systems must collect at 
least three routine samples during the next month, except that the 
State may waive this requirement if the conditions of paragraph (f)(1), 
(2), or (3) of this section are met. Systems may either collect samples 
at regular time intervals throughout the month or may collect all 
required routine samples on a single day if samples are taken from 
different sites. Systems must use the results of additional routine 
samples in coliform treatment technique trigger calculations.
    (1) The State may waive the requirement to collect three routine 
samples the next month in which the system provides water to the public 
if the State, or an agent approved by the State, performs a site visit 
before the end of the next month in which the system provides water to 
the public. Although a sanitary survey need not be performed, the site 
visit must be sufficiently detailed to allow the State to determine 
whether additional monitoring and/or any corrective action is needed. 
The State cannot approve an employee of the system to perform this site 
visit, even if the employee is an agent approved by the State to 
perform sanitary surveys.
    (2) The State may waive the requirement to collect three routine 
samples the next month in which the system provides water to the public 
if the State has determined why the sample was total coliform-positive 
and has established that the system has corrected the problem or will 
correct the problem before the end of the next month in which the 
system serves water to the public. In this case, the State must 
document this decision to waive the following month's additional 
monitoring requirement in writing, have it approved and signed by the 
supervisor of the State official who recommends such a decision, and 
make this document available to the EPA and the public. The written 
documentation must describe the specific cause of the total coliform-
positive sample and what action the system has taken and/or will take 
to correct this problem.
    (3) The State may not waive the requirement to collect three 
additional routine samples the next month in which the system provides 
water to the public solely on the grounds that all repeat samples are 
total 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) Beginning [DATE THREE YEARS AFTER PUBLICATION OF THE FINAL 
RULE], all seasonal systems must demonstrate completion of a State-
approved start-up procedure, which may include a requirement for a 
startup sample prior to serving water to the public.
    (b) Routine monitoring frequency for total coliforms. Subpart H 
systems of this part (including consecutive systems) must monitor 
monthly. Systems may not reduce monitoring.
    (c) Unfiltered subpart H systems. A subpart H system of this part 
that does not practice filtration in compliance with subparts H, P, T, 
and W must collect at least one total coliform sample near the first 
service connection each day the turbidity level of the source water, 
measured as specified in 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) Beginning [DATE THREE YEARS AFTER PUBLICATION OF THE FINAL 
RULE], all seasonal systems must demonstrate completion of a State-
approved start-up procedure, which may include a requirement for a 
startup sample prior to serving water to the public.
    (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

[[Page 41013]]

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. In the case of an extension, the State must 
specify how much time the system has to collect the repeat samples. The 
State cannot waive the requirement for a system to collect repeat 
samples in paragraphs (a)(1) through (a)(3) of this section.
    (2) The system must collect all repeat samples on the same day, 
except that the State may allow a system with a single service 
connection to collect the required set of repeat samples over a three-
day period or to collect a larger volume repeat sample(s) in one or 
more ample containers of any size, as long as the total volume 
collected is at least 300 ml.
    (3) The system must collect an additional set of repeat samples in 
the manner specified in paragraphs (a)(1) through (a)(3) of this 
section if one or more repeat samples in the current set of repeat 
samples is total 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 has been exceeded as a 
result of a repeat sample being total coliform-positive and notifies 
the State. If a trigger identified 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 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, 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 requirements for protection 
against potential fecal contamination.

    (a) Treatment technique triggers. Systems must conduct assessments 
in accordance with paragraph (b) of this section after exceeding 
treatment technique triggers in paragraphs (a)(1) and (a)(2) of this 
section.
    (1) Level 1 treatment technique triggers.
    (i) For systems taking 40 or more samples per month, the system 
exceeds 5.0% total coliform-positive samples for the month.
    (ii) For systems taking fewer than 40 samples per month, the system 
has two or more total coliform-positive samples in the same month.
    (iii) The system fails to take every required repeat sample after 
any single total coliform-positive sample.
    (2) Level 2 treatment technique triggers.
    (i) An E. coli MCL violation, including failure to collect repeat 
samples within the required time following an E. coli- positive routine 
sample.
    (ii) A second Level 1 trigger as defined in paragraph (a)(1) of 
this section, within a rolling 12-month period, unless the State has 
determined a likely reason that the initial samples that caused the 
Level 1 treatment technique trigger were total coliform-positive and 
has established that the system has corrected the problem.
    (iii) For systems with approved annual monitoring, a Level 1 
trigger in two consecutive years.
    (b) Requirements for assessments. (1) Systems must ensure that 
Level 1 and 2 assessments are conducted in order to identify the 
possible presence of sanitary defects and defects in distribution 
system coliform monitoring practices. Level 2 assessments must be 
conducted by parties approved by the State.

[[Page 41014]]

    (2) When conducting assessments, systems must ensure that the 
assessor evaluates minimum elements that include review and 
identification of inadequacies in sample sites; sampling protocol; 
sample processing; atypical events that could affect distributed water 
quality or indicate that distributed water quality was impaired; 
changes in distribution system maintenance and operation that could 
affect distributed water quality (including water storage); source and 
treatment considerations that bear on distributed water quality, where 
appropriate (e.g., small ground water systems); and existing water 
quality monitoring data. The State may tailor specific assessment 
elements to the size and type of the system. Systems may tailor their 
assessment activities based on the characteristics of the distribution 
system (consistent with any State directives).
    (3) Level 1 Assessments. A system must conduct a Level 1 assessment 
consistent with State requirements if the system exceeds one of the 
treatment technique triggers in paragraph (a)(1) of this section.
    (i) The system must complete a Level 1 assessment as soon as 
practical after failure to take a repeat sample or after notification 
of monitoring results. In the completed assessment form, the system 
must identify sanitary defects detected, corrective actions completed, 
and a timetable for any corrective actions not already completed. The 
assessment form may also note that no sanitary defects were identified. 
The system must submit the completed Level 1 assessment form to the 
State within 30 days after determination of exceeding the trigger.
    (ii) If the State reviews the completed Level 1 assessment and 
determines that the assessment is not sufficient, the State must 
consult with the system. If necessary after consultation, the system 
must submit a revised assessment form to the State on an agreed-upon 
schedule not to exceed 30 days from the date of the consultation. Upon 
completion and submission of the assessment form by the system, the 
State must determine if the system has identified a likely cause for 
the Level 1 trigger and, if so, establish that the system has corrected 
the problem, or has included a schedule acceptable to the State for 
correcting the problem.
    (4) Level 2 Assessments. A system must ensure that a Level 2 
assessment consistent with State requirements is conducted if the 
system exceeds one of the treatment technique triggers in paragraph 
(a)(2) of this section. The State may direct expedited actions or 
additional actions in the case of an E. coli MCL violation.
    (i) The system must ensure that a Level 2 assessment is completed 
by the State or by a party approved by the State as soon as practical 
after failure to take a repeat sample or after notification of 
monitoring results. The system must submit a completed Level 2 
assessment form to the State within 30 days after the determination of 
exceeding the trigger. The assessment form must describe sanitary 
defects detected, corrective actions completed, and a timetable for any 
corrective actions not already completed. The assessment form may also 
note that no sanitary defects were identified.
    (ii) The system may conduct Level 2 assessments if the system has 
staff or management with the certification or qualifications specified 
by the State unless otherwise directed by the State.
    (iii) If the State reviews the completed Level 2 assessment and 
determines that the assessment is insufficient, the State must consult 
with the system. If necessary after consultation, the system must 
submit a revised assessment form to the State on an agreed-upon 
schedule not to exceed 30 days. Upon completion and submission of the 
assessment form by the system, the State must determine if the system 
has identified a likely cause for the Level 2 trigger and determine 
whether the system has corrected the problem, or has included a 
schedule acceptable to the State for correcting the problem.
    (c) Corrective Action. Systems must correct sanitary defects found 
through either Level 1 or 2 assessments conducted under paragraph (b) 
of this section. For corrections not completed by the time of 
submission of the assessment form, the system must complete the 
corrective action(s) in compliance with a schedule determined by the 
State in consultation with the system. The system must notify the State 
when each scheduled corrective action is completed.
    (d) Consultation. At any time during the assessment or corrective 
action phase, either the water system or the State may request a 
consultation with the other party to determine the appropriate actions 
to be taken. The system may consult with the State on all relevant 
information that may impact on its ability to comply with a requirement 
of this subpart, including the method of accomplishment, an appropriate 
timeframe, and other relevant information.

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. 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).
    (c) Monitoring violations. Failure to take every required routine 
or additional routine sample in a compliance period is a routine 
monitoring violation. Failure to analyze for E. coli following a total 
coliform routine sample is a monitoring violation.
    (d) Reporting violations. (1) Failure to submit a monitoring report 
or completed assessment form after a system properly conducts 
monitoring or assessment is a reporting violation.
    (2) Failure to notify the State following an E. coli-positive 
sample as required by Sec.  141.858(b)(1) is a reporting violation.

Sec.  141.861  Reporting and recordkeeping.

    (a) Reporting. (1) A system that has violated the E. coli MCL must 
report the violation to the State no later than the end of the next 
business day after it learns of the violation, and notify the public in 
accordance with subpart Q of this part. A system must notify the State 
no later than the end of the next business day after it learns of an E. 
coli-positive sample.
    (2) A system that has violated the treatment technique for total 
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. 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.
    (3) A system that has failed to comply with a coliform monitoring 
requirement must report the monitoring violation to the State within 10 
days after the system discovers the violation, and notify the

[[Page 41015]]

public in accordance with subpart Q of this part.
    (b) Recordkeeping. The system must maintain any assessment form, 
regardless of who conducts the assessment, and documentation of 
corrective actions completed as a result of those assessments, or other 
available summary documentation of the sanitary defects and corrective 
actions taken under 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.

PART 142--NATIONAL PRIMARY DRINKING WATER REGULATIONS 
IMPLEMENTATION

    21. The authority citation for part 142 continues to read as 
follows:

    Authority:  42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 
300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.

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

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(b)(2), 141.856(c), and 141.857(c) 
of this chapter--Any decision to waive the 24-hour time limit for 
collecting repeat samples after a total coliform-positive routine 
sample, or to extend the 24-hour limit for collection of samples 
following invalidation, or for an unfiltered subpart H system of this 
part to collect a total coliform sample following a turbidity 
measurement exceeding 1 NTU.
    (B) Sections 141.854(j) and 141.855(f) of this chapter--Any 
decision to allow a system to waive the requirement for three routine 
samples the month following a total coliform-positive sample. The 
record of the waiver decision must contain all the items listed in 
those sections.
    (C) Section 141.853(c) of this chapter--Any decision to invalidate 
a total coliform-positive sample. If the decision to invalidate a total 
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 141.855(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.
    (B) Section 141.854(e) of this chapter--Any decision to reduce the 
total coliform monitoring frequency for a non-community water system 
using only ground water and serving 1,000 or fewer people to less than 
once per quarter, as provided in 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.
    (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.
* * * * *
    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.
* * * * *
    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

[[Page 41016]]

that Level 2 assessments provide a more detailed examination of the 
system (including the system's monitoring and operational practices) 
than do Level 1 assessments through the use of more comprehensive 
investigation and review of available information, additional internal 
and external resources, and other relevant practices.
    (B) Examples of sanitary defects.
    (C) Examples of assessment forms or formats.
    (D) Methods that systems may use to consult with the State on 
appropriate corrective actions.
    (iv) Invalidation of routine and repeat samples collected under 40 
CFR part 141, subpart Y--The criteria and process for invalidating 
total coliform and E. coli-positive samples under 40 CFR part 141, 
subpart Y. This description must include criteria to determine if a 
sample was improperly processed by the laboratory, reflects a domestic 
or other non-distribution system plumbing problem or reflects 
circumstances or conditions that do not reflect water quality in the 
distribution system.
    (v) Approval of individuals allowed to conduct Level 2 assessments 
under 40 CFR part 141, subpart Y--The criteria and process for approval 
of individuals allowed to conduct Level 2 assessments under 40 CFR part 
141, subpart Y.
    (vi) Special monitoring evaluation--The procedure for performing 
special monitoring evaluations during sanitary surveys for ground water 
systems serving 1,000 or fewer people to determine whether systems are 
on an appropriate monitoring schedule.
    (vii) Seasonal systems--How the State will identify seasonal 
systems, how the State will determine when systems on less than monthly 
monitoring must monitor, and what start-up provisions seasonal system 
must meet under 40 CFR part 141, subpart Y.
    (viii) Additional criteria for reduced monitoring--How the State 
will require systems on reduced monitoring to demonstrate:
    (A) Continuous disinfection entering the distribution system and a 
residual in the distribution system.
    (B) Cross connection control.
    (C) Other enhancements to water system barriers.
    25. Section 142.63 is amended by revising paragraph (b) to read as 
follows:

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 [DATE THREE YEARS 
FOLLOWING PUBLICATION OF THE FINAL RULE], at which time the total 
coliform MCL is no longer applicable.

[FR Doc. 2010-15205 Filed 7-13-10; 8:45 am]
BILLING CODE 6560-50-P