[Federal Register Volume 75, Number 134 (Wednesday, July 14, 2010)]
[Proposed Rules]
[Pages 40926-41016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15205]
[[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
Federal Register / Vol. 75 , No. 134 / Wednesday, July 14, 2010 /
Proposed Rules
[[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:
[email protected]. 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
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H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act
J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations
K. Consultations with the Science Advisory Board, National
Drinking Water Advisory Council, and the Secretary of Health and
Human Services
L. Impacts on Sensitive Subpopulations as Required by Section
1412(b)(3)(C)(i) of the 1996 Amendments of the Safe Drinking Water
Act (SDWA)
M. Plain Language
VIII. References
II. Background
A. Statutory Authority
The Safe Drinking Water Act (SDWA) requires the EPA to review and
revise, as appropriate, each existing national primary drinking water
regulation (NPDWR) at least once every six years (SDWA section
1412(b)(9), 42 U.S.C. 300g-1(b)(9)). In 2003, EPA completed its review
of the Total Coliform Rule (TCR) and 68 NPDWRs for chemicals that were
promulgated prior to 1997 (USEPA 2003, 68 FR 42908, July 18, 2003). The
purpose of the review was to identify new health risk assessments,
changes in technology, and other factors that would provide a health-
related or technological basis to support a regulatory revision that
would maintain or improve public health protection. In the Six-Year
Review 1 determination published in July 2003 (USEPA 2003, 68 FR 42908,
July 18, 2003), EPA stated its intent to revise the 1989 TCR (also
referred to as the ``current TCR'').
B. Total Coliform Rule Distribution System Advisory Committee (TCRDSAC)
In June 2007, EPA established the Total Coliform Rule/Distribution
System Advisory Committee (``TCRDSAC'' or ``the advisory committee'')
in accordance with the provisions of the Federal Advisory Committee
Act, 5 U.S.C. App.2, 9 (c), to provide recommendations to EPA on
revisions to the 1989 TCR and on what information about distribution
system issues is needed to better understand and address possible
public health impacts from potential degradation of drinking water
distribution systems (USEPA 2007a, 72 FR 35869, June 29, 2007). The
decision to include a review of distribution system issues was made, in
part, to address recommendations made by the Stage 2 Microbial and
Disinfection Byproducts Federal Advisory Committee in December 2000
(USEPA 2000b, 65 FR 83015, December 29, 2000). The TCRDSAC used
available information to analyze options for revisions to the TCR. The
TCRDSAC also considered research and information needed to better
understand and address public health risks from contamination of
distribution systems.
The advisory committee consisted of representatives of EPA, State
and local public health and regulatory agencies, consumer
organizations, environmental organizations, local elected officials,
Indian Tribes, and drinking water suppliers. A technical workgroup was
also formed to provide the advisory committee with necessary technical
support and analysis to facilitate the committee's discussions. The
advisory committee met on 13 occasions between July 2007 and September
2008. All advisory committee members agreed to and signed the final
Agreement in Principle (AIP) in September 2008. All of the
recommendations of the advisory committee are found in the signed AIP.
Pursuant to the AIP, EPA agreed to propose revisions to the TCR that,
to the maximum extent consistent with EPA's legal obligations, have the
same substance and effect as the elements of the AIP. Each party
represented on the advisory committee agreed in the AIP not to take any
action to inhibit the adoption and implementation of final rule(s) to
the extent it and the corresponding preamble have the same substance
and effect as the elements of the AIP. EPA also agreed in the AIP to
develop a Research and Information Collection Partnership (RICP) to
``inform and support the drinking water community in developing future
national risk management decisions pertaining to drinking water
distribution systems'' by providing ``a formal process for systematic
planning, implementation, analysis, and communication of distribution
system research and information collection'' (USEPA 2008c). A
discussion of the RICP can be found in section V of this preamble. The
AIP and details about the advisory committee can be found at EPA's Web
site at: http://www.epa.gov/safewater/disinfection/tcr/regulation_revisions.html.
In addition to the outreach mentioned above, EPA agreed to engage
in various future stakeholder meetings at least annually, to which all
advisory committee members and the public at large would be invited. In
April 2009, EPA held its first annual stakeholder meeting to provide
draft proposed regulation updates and an opportunity for stakeholders
to provide feedback on the development of the proposed RTCR.
C. Other Outreach Processes
In addition to consulting with the advisory committee, EPA engaged
in several other activities as part of the Agency's outreach to
stakeholders in developing the proposed RTCR. EPA held a technical
workshop in Washington, DC, from January 30 to February 1, 2007, to
discuss available information on the current TCR and available
information regarding risks in distribution systems in support of
revisions to the TCR. Other EPA outreach activities, namely the
National Drinking Water Advisory Council consultation, Science Advisory
Board consultation, and the Tribal consultation, are discussed in
section VII of this preamble.
D. Public Health Concerns Addressed by the Proposed Revised Total
Coliform Rule
1. Public Health Concerns, Fecal Contamination, and Waterborne
Pathogens
The proposed RTCR aims to increase public health protection through
the reduction of potential pathways of entry for fecal contamination
into the distribution system. Since these potential pathways represent
vulnerabilities in the distribution system whereby fecal contamination
and/or waterborne pathogens, including bacteria, viruses and parasitic
protozoa could possibly enter the system, the reduction of these
pathways in general should lead to reduced exposure and associated risk
from these contaminants. Fecal contamination and waterborne pathogens
can cause a variety of illnesses, including acute gastrointestinal
illness (AGI) with diarrhea, abdominal discomfort, nausea, vomiting,
and other symptoms. Most AGI cases are of short duration and result in
mild illness. Other more severe illnesses caused by waterborne
pathogens include hemolytic uremic syndrome (HUS) (kidney failure),
hepatitis, and bloody diarrhea (WHO 2004). Chronic disease such as
irritable bowel syndrome, reduced kidney function, hypertension and
reactive arthritis can result from infection by a waterborne agent
(Clark et al. 2008).
When humans are exposed to and infected by waterborne enteric
pathogens, the pathogens become capable of reproducing in the
gastrointestinal tract. As a result, healthy humans shed pathogens in
their feces for a period ranging from days to weeks. This shedding of
pathogens often occurs in the absence of any signs of clinical illness.
Regardless of whether a pathogen causes clinical illness in the
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person who sheds it in his or her feces, the pathogen being shed may
infect other people directly by person-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.
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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.
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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
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read and understand the rule, and a total of eight hours to plan and
assign appropriate personnel and resources to carry out rule
activities.
b. Revising sampling plans. Under the AIP and Alternative options,
all PWSs subject to the proposed RTCR incur 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.
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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
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Berlin, L.E., M.L. Rorabaugh, F. Heldrich, K. Roberts, T. Doran, and
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Carey, C.M., H. Lee, and J.T. Trevors. 2004. Biology, persistence
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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
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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
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Clesceri, L.S., A.E. Greenberg, and A.D. Eaton, eds. 1998. Standard
Methods for the Examination of Water and Wastewater, 20th ed.
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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
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Craun, G.F., R.L. Calderon and T.J. Wade, 2006. Assessing waterborne
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Eaton, A.D., L.S. Clesceri, E.W. Rice, and A.E. Greenberg, eds.
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Edberg, S.C., E.W. Rice, R.J. Karlin and M. J. Allen. 2000.
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Falco, R. and S.I. Israel. 2009. Waterborne Salmonella Outbreak in
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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.
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Infection and Emergence of Phenotypic Variants, Emerging Infectious
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Fricker, C., P. Warden, D. Silvaggio, E. Gleeseman, R. Tamanaha, J.
Rust, B. Eldred. 2003. Comparison of Five Commercially Available
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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