EPA-815-Z-06-005
Wednesday,

November 8, 2006
Part II



Environmental

Protection Agency

40 CFR Parts 9, 141, and 142
National Primary Drinking Water
Regulations: Ground Water Rule; Final
Rule

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                                                                                                             67427
Corrections
                                       Federal Register

                                       Vol. 71,  No. 224

                                       Tuesday, November 21. 2006
This section of the FEDERAL REGISTER
contains editorial corrections of previously
published Presidential, Rule, Proposed Rule,
and Notice documents. These corrections are
prepared by the Office of the Federal
Register. Agency prepared corrections are
issued as signed documents and appear in
the appropriate document categories
elsewhere in the issue.
Wednesday, November 8, 2006, make
the following correction:

§141.402  [Corrected]

  On page 65655. in § 141.402(c)(2), the
table is corrected to read as follows:
ENVIRONMENTAL PROTECTION
AGENCY

40 CFR Part 141

[EPA-HQ-OW-2002-0061; FRL-8231-9]

RIN 2040-AA97

National Primary Drinking Water
Regulations: Ground Water Rule

Correction
  In rule document 06-8763 beginning
on page 65574 in the issue of
                               ANALYTICAL METHODS FOR SOURCE WATER MONITORING
              Fecal indicator1
                   Methodology
         Method citation
£. co//
Enterococci
Coliphage
    Colilert3 	
    Colisure3 	
    Membrane Filter Method with Ml Agar 	
    m-ColiBlue24Test5 	
    E*Colite Test6 	
    EC-MUG7	
    NA-MUG7	
    Multiple-Tube Technique	
    Membrane Filter Technique  	
    Membrane Filter Technique  	
    Enterolert9	
    Two-Step  Enrichment  Presence-Absence  Proce-
     dure.
    Single Agar Layer Procedure	
9223 B.2
9223 B.2
EPA Method 1604.4
9221 F.2
9222 G.2
9230B.2
9230C.2
EPA Method 1600.8

EPA Method 1601.10

EPA Method 1602.11
[FR Doc. C6-8763 Filed 11-20-06; 8:45 am]

BILLING CODE 1505-01-D

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65574    Federal  Register/Vol.  71, No.  216/Wednesday, November 8, 2006/Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY .

40 CFR Parts 9,141 and 142
[EPA-HQ-OW-2002-0061;  FRL-8231-9]
RIN 2040-AA97

National Primary Drinking Water
Regulations: Ground Water Rule

AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.

SUMMARY: The Environmental Protection
Agency is promulgating a National
Primary Drinking Water Regulation, the
Ground Water Rule, to provide for
increased protection against microbial
pathogens in public water systems that
use ground water sources. This final
rule is in accordance with the Safe
Drinking Water Act as amended, which
requires the Environmental Protection
Agency to promulgate National Primary
Drinking Water Regulations requiring
disinfection as a treatment technique for
all public water systems, including
surface water systems and, as necessary,
ground water systems.
  The Ground Water Rule establishes a
risk-targeted approach to target ground
water systems that are susceptible to
fecal contamination, instead of requiring
disinfection for all ground water
systems. The occurrence  of fecal
indicators in a drinking water supply is
an indication of the potential presence
of microbial pathogens that may  pose a
threat to public health. This  rule
requires ground water systems that are
at risk of fecal contamination to take
corrective action to reduce cases of
illnesses and deaths due  to exposure to
microbial pathogens.
DATES: This  final rule is effective on
January 8, 2007. The incorporation by
reference of certain publications listed
in this rule is approved by the Director
of the Federal Register as of January 8,
2007. For judicial review purposes, this
final rule is promulgated as of 1 p.m.
Eastern time on November 22, 2006, as
provided in  40 Code of Federal
Regulations  (CFR) 23.7. The  compliance
date, unless otherwise noted, for the
rule requirements is December 1, 2009.
ADDRESSES:  The Environmental
Protection Agency (EPA) has established
a docket for this action under Docket ID
No. EPA-HQ-OW-2002-0061. All
documents in the docket are listed on
the http://www.regulations.gov Web
site. Although listed in the index, some
information is not publicly available,
e.g., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such  as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically through
http://www.regulations.gov or in hard
copy at the Water Docket.
  Note: The EPA Docket Center suffered
damage due to flooding during the last week
of June 2006. The Docket Center is
continuing to operate. However, during the
cleanup, there will be temporary changes to
Docket Center telephone numbers, addresses,
and hours of operation for people who wish
to visit the Public Reading Room to view
documents. Consult EPA's Federal Register
notice at 71 FR 54815 (September 19, 2006)
or the EPA Web site at http://www.epa.gov/
epahome/dockets.htm for current
information on docket status, locations and
telephone numbers.

FOR FURTHER INFORMATION CONTACT:
Crystal Rodgers, 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)
564-5275; e-mail address:
rodgers.crystal@epa.gov. For general
information, contact the Safe Drinking
Water Hotline, telephone number: (800)
426-4791. The Safe Drinking Water
Hotline is open Monday through Friday,
excluding legal holidays, from 10 a.m.
to 4 p.m. Eastern time.
SUPPLEMENTARY INFORMATION:

I. General Information
  Entities potentially regulated by the
Ground Water Rule (GWR)  are public
water systems (PWSs) using ground
water as a drinking water source.
Regulated categories and entities
include the following:
Category
Industry
State, Local, Tribal or
Federal Govern-
ments.
Examples of
regulated entities
Public ground water
systems.
Public ground water
systems.
  This table is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
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
applicability criteria found in § 141.400
of this rule. If you have questions
regarding the applicability of this action
to a particular entity, consult the person
listed in the preceding FOR FURTHER
INFORMATION CONTACT section.

Abbreviations Used in This Document
AIDS  Acquired Immune Deficiency
    Syndrome
AGI  Acute Gastrointestinal Illness
AWWA  American Water Works Association
ASDWA  Association of State Drinking
    Water Administrators
AWWARF   American Water Works
    Association Research Foundation
AWWSCo  American Water Works Service
    Company
BGLB  Brilliant green lactose bile broth
BGM  Buffalo Green Monkey
BMPs  Best Management Practices
CAFO  Concentrated Animal Feeding
    Operation
CBI  Confidential Business Information
CCR Consumer Confidence Report
CDBG  Community Development Block
    Grant
CDC Centers for Disease Control and
    Prevention
CFR Code of Federal Regulation
COI  Cost of Illness
CT  The Residual Concentration of
    Disinfectant  (mg/L) Multiplied by the
    Contact Time (in minutes)
CWS  Community Water System
CWSS  Community Water System Survey
DBFs  Disinfection Byproducts
DWSRF  Drinking Water State Revolving
    Fund
EA  Economic Analysis
EPA United States Environmental
    Protection Agency
FR  Federal Register
GAO  United States Government
    Accountability Office
GI  Gastrointestinal
GWUDI  Ground Water Under the Direct
    Influence of Surface Water
GWR  Ground Water Rule
GWS  Ground Water  System
HAV  Hepatitis A Virus
HRRCA  Health  Risk Reduction and Cost
    Analysis
HSA  Hydrogeologic  Sensitivity Assessment
ICR  Information Collection Request
IESWTR  Interim Enhanced Surface Water
    Treatment Rule
IRFA  Initial Regulatory Flexibility Analysis
LTB Lauryl tryptose broth
m  Meters
mL   Milliliters
MCL  Maximum Contaminant Level
mg/L  Milligrams per Liter
MPNIU  Most Probable Number of Infectious
    Units
MRDL   Maximum Residual Disinfectant
    Level
MWCO  Molecular Weight Cut-Off
NCWS   Non-Community Water System
NDWAC  National Drinking Water Advisory
    Council
NF  Nanofiltration
NODA   Notice of Data Availability
NTNCWS  Non-Transient Non-Community
    Water System
NTTAA  National  Technology Transfer and
    Advancement Act of 1995
NPDWR  National Primary Drinking Water
    Regulation
O&M  Operation and Maintenance

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            Federal Register/Vol.  71, No. 216/Wednesday,  November 8, 2006/Rules and  Regulations     65575
OMB  Office of Management and Budget
F-A  Presence-absence
PCR  Polymerase Chain Reaction
PNR  Public Notification Rule
PWS   Public Water System
RFA  Regulatory Flexibility Act
R1A  Regulatory Impact Analysis
RO  Reverse Osmosis
RT-PCR  Reverse Transcriptase—
    Polymerase Chain Reaction
SAB  Science Advisory Board
SBREFA  Small Business Regulatory
    Enforcement Fairness Act
SD  Standard Deviation
SDWA  Safe Drinking Water Act
SDWIS  Safe Drinking Water Information
    System
SEFA~  Small Entity Flexibility Analysis
Stage 2 DBPR  Stage 2 Disinfectants and
    Disinfection Byproducts Rule
SWAP  Source Water Assessment Program
SWTR  Surface Water Treatment Rule
TCR  Total Coliform Rule
TNCWS   Transient Non-Community Water
    System
LJIC  Underground Injection Control
UMRA  Unfunded Mandates Reform Act
US  United States
USGS  United States Geological Survey
UV  Ultraviolet Radiation
VSL  Value of Statistical Life
WHO  World  Health Organization
WTP   Willingness To Pay

Table of Contents
I. General  Information
II. Summary
  A. Why  Is EPA Promulgating the GWR?
  B. What Docs the GWR Require?
  1. Sanitary Surveys
  2. Source Water Monitoring
  3. Treatment Technique Requirements
  4. Compliance Monitoring
  C. How  Has the Final Rule Changed From
    What  EPA Proposed?
  D. Does  This Regulation Apply to  My
    Water System?
III. Background
  A. What Is the Statutory Authority for the
    GWR?
  B. What Is the Regulatory History  of the
    GWR and How Were Stakeholders
    Involved?
  C. What Public Health Concerns Does the
    GWR Address?
  1. Introduction
  2. Waterborne Disease Outbreaks in
    Ground Water Systems
  3. Microbial  Contamination in Public
    Ground Water Systems
  4. Potential Risk Implications From
    Occurrence Data
IV. Discussion of GWR Requirements
  A. Sanitary Surveys
  1. What  Are the Requirements of This
    Rule?
  2. What  Is EPA's Rationale for the  GWR
    Sanitary Survey Requirements?
  3. What  Were the Key Issues Raised by
    Commenters on the Proposed GWR
    Sanitary Survey Requirements?
  B. Source Water Monitoring
  1. What  Are the Requirements of This
    Rule?
  2. What  Is EPA's Rationale for the  GWR
    Source Water Monitoring Requirements?
  3. What Were the Key Issues Raised by
    Commenters on the Proposed GWR
    Source Water Monitoring Requirements?
  C. Corrective Action Treatment Techniques
    for Systems With Significant
    Deficiencies or Source Water Fecal
    Contamination
  1. What Are the Requirements of This
    Rule?
  2. What Is EPA's Rationale for the GWR
    Treatment Technique Requirements?
  3. What Were the Key Issues Raised by
    Commenters on the Proposed GWR
    Treatment Technique Requirements?
  D. Providing Notification and Information
    to the Public
  1. What Are the Requirements of This
    Rule?
  2. What Is EPA's Rationale for the Public
    Notice Requirements?
  3. What Were  the Key Issues Raised by
    Commenters on the Proposed GWR
    Public Notification Requirements?
  E. What Are the Reporting and
    Recordkeeping Requirements for
    Systems?
  1. Reporting Requirements
  2. Recordkeeping Requirements
  3. What Were  the Key Issues Raised by
    Commenters on the Proposed GWR
    Reporting and Recordkeeping
    Requirements for Systems?
  F. What Are the Special Primacy,
    Reporting, and Recordkeeping
    Requirements for States?
  1. Primacy Requirements
  2. Reporting Requirements
  3. Recordkeeping Requirements
  4. What Were  the Key Issues Raised by
    Commenters on the Proposed GWR
    Special Primacy, Reporting, and
    Recordkeeping Requirements for States?
  G. Variances and Exemptions
  1. Variances
  2. Exemptions
V. Explanation of Extent of GWR
  A. Mixed Systems
  B. Cross-Connection Control
VI. Implementation
VII. Economic Analysis (Health Risk
    Reduction and Cost Analysis)
  A. How Has the Final Rule Alternative
    Changed From the Proposed Rule
    Alternative?
  B. Analyses That Support This Rule
  1. Occurrence Analysis
  2. Risk Analyses
  C. What Are~the Benefits of the GWR?
  1. Calculation of Baseline  Health Risk
  2. Calculation of Avoided Illnesses and
    Deaths
  3. Derivation of Quantified Benefits
  4. Nonquantifiable Benefits
  5. How Have the Benefits Changed Since
    the Proposal?
  D. What Are the Costs of the GWR?
  1. Summary of Quantified Costs
  2. Derivation of Quantified Costs
  3. Nonquantifiable Costs
  4. How Have the Costs Changed Since the
    Proposal?
  E. What Is the Potential Impact of the GWR
    on Households?
  F. What Are the Incremental Costs and
    Benefits of the GWR?
  G. Are There Any Benefits From
    Simultaneous Reduction of Co-Occurring
    Contaminants?
  H. Is There Any Increase in Risk From
    Other Contaminants?
  1. What Are the Effects of the Contaminant
    on the General Population and Groups
    Within the General Population That Are
    Identified as Likely To Be at Greater Risk
    of Adverse Health'Effects?
  1. Risk of Acute Viral Illness to Children
    and Pregnant Women
  2. Risk of Viral Illness to the Elderly and
    Immunocompromised
  J. What Are the Uncertainties in the Risk,
    Benefit, and Cost Estimates for the GWR?
  1. The Baseline Numbers of Ground Water
    Systems. Populations Served, and
    Associated Disinfection Practice
  2. The Numbers of Wells Designated as
    More Versus Less Vulnerable
  3. The Baseline Occurrence of Viruses and
    E. coli in Ground Water Wells
  4. For the Sanitary Survey Provisions, the
    Percentage of Systems Identified as
    Having Significant Deficiencies, the
    Percentage of These Deficiencies That
    Are Corrected, and  State Costs for
    Conducting Surveys
  5. The Predicted Rates at Which Virally
    Contaminated (and Non-Contaminated)
    Wells Will Be Required To Take Action
    After Finding E. coli Ground Water
    Sources
  6. The Infectivity of Echovirus and
    Rotavirus Used to Represent Viruses
    That Occur in Ground Water
  7. The Costs of Illnesses Due to Ingcstion
    of Contaminated Ground Water
  8. The Costs of Taking Action After
    Finding E. coli in Ground Water Sources
  9. Nonquantifiable Benefits
  10. Optional Assessment Source Water
    Monitoring
  11. Corrective Actions and Significant
    Deficiencies
  12. Uncertainty Summary
  K. What Is the Benefit/Cost Determination
    for the GWR?
  L. What Were Some of the Major
    Comments Received on the Economic
    Analysis and What  Are EPA's
    Responses?
  1. Costs
  2. Benefits
  3. Risk Management
VIII. Statutory and Executive Order Reviews
  A. Executive Order 12866: Regulatory
    Planning and Review
  B. Paperwork Reduction Act
  C. Regulatory Flexibility Act (RFA)
.  D. Unfunded Mandates Reform Act
    (UMRA)
  E. Executive Order 13132: Federalism
  F. Executive Order 13175: Consultation
    and Coordination With Indian Tribal
    Governments
  G. Executive Order 13045: Protection of
    Children From Environmental Health
    Risks and Safety Risks
  H. Executive Order 13211: Actions That
    Significantly Affect Energy Supply,
    Distribution,  or LIse
  1. Energy Supply
  2. Energy Distribution
  3. Energv Use

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65576    Federal Register/Vol. 71, No. 216/Wednesday, November  8,  2006/Rules  and  Regulations
  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. Congressional Review Act
  L. Analysis of the Likely Effect of
   Compliance With the GWR on the
   Technical, Financial, and Managerial
   Capacity of Public Water Systems
IX. Consultation With Science Advisory
   Board, National Drinking Water
   Advisory Council, and the Secretary of
   Health and Human Services; and Peer
   Review
X. References

II. Summary
  This section includes a discussion of
the purpose of the Ground Water Rule
(GWR) and a summary of the GWR
requirements.

A. Why Is EPA Promulgating the GWR?
  EPA is promulgating the GWR to
provide for increased protection against
microbial pathogens, specifically viral
and bacterial pathogens, in public water
systems (PWSs) that use ground water
sources. EPA is particularly concerned
about ground water systems (GWSs) that
are susceptible to fecal contamination
because these systems may be at risk of
supplying water that contains harmful
microbial pathogens. Viral pathogens
found in GWSs may include enteric
viruses such as Echovirus, Coxsackie
viruses, Hepatitis A and E, Rotavirus
and Noroviruses (i.e., Norwalk-like
viruses) and enteric bacterial pathogens
such as Escherichia coli (most E. coli is
harmless but a few species are
pathogenic, including E. coli O157:H7),
Salmonella species, Shigella species,
and Vibrio cholerae. Ingestion of these
pathogens can cause gastroenteritis or,
in certain cases, serious illnesses such
as meningitis, hepatitis, or myocarditis.
Health implications in  sensitive
subpopulations (e.g., children, elderly,
immuno-compromised) may be severe
(e.g., hemolytic uremic syndrome) and
may cause death.
  One goal of the GWR is to identify
and target GWSs that are susceptible to
fecal contamination because such
contamination is the likely source of
viral and bacterial pathogens in
drinking water supplies. Ground water
is fecally contaminated when fecal
indicators (e.g.. E. coli, enterococci, or
coliphage) are present. While fecal
indicators typically are not harmful
when ingested, their presence
demonstrates that there is a pathway for
pathogenic viruses and bacteria to enter
ground water sources. Another key
objective of the rule is to protect public
health by requiring these higher risk
GWSs to monitor and, when necessary,
take corrective action. Corrective action
can include correcting all significant
deficiencies; providing an alternate
source of water; eliminating the source
of contamination; or providing
treatment that reliably achieves at least
99.99 percent (4-log) treatment of
viruses (using inactivation, removal, or
a State-approved combination of 4-log
virus inactivation and removal) for each
contaminated ground water source.
Each of these corrective actions is
intended to remove all or nearly all fecal
contamination, including both viral and
bacterial pathogens. This rule
implements section 1412(b)(8) of the
1996 Safe Drinking Water Act (SDWA)
Amendments to promulgate a rule
requiring GWSs to disinfect "as
necessary." The risk-targeted approach
in this rule is a critical distinction from
the approach outlined in the 1986
SDWA, which would have required all
PWSs using surface water or ground
water to disinfect. Because there are so
many GWSs (approximately 147,000) in
the United  States, such a requirement
would have been a great challenge for
systems and States to implement.
  This rule is necessary to protect
public health because current regulatory
provisions  for GWSs (for example,
sanitary survey requirements in the
Total Coliform Rule (TCR) (54 FR 27544,
June 29, 1989) (USEPA, 1989a)) do not
adequately address fecal contamination
at the ground water source. In fact, no
Federal regulation exists that requires
either monitoring of ground water
sources or corrective action upon
finding fecal contamination or
identifying a significant deficiency
during a sanitary survey. In addition,
the U.S. Government Accountability
Office  (GAO) 1993 report (USGAO,
1993) found that many sanitary surveys
did not evaluate one or more of the
components that EPA recommended be
evaluated, and that efforts to ensure
correction were often limited. Also,
GAO found that follow-up on major
problems was often lacking. Moreover,
the report found that problems
associated with system infrastructure
identified during sanitary surveys
frequently remain uncorrected. The
GWR provides much needed public
health protection by requiring systems
that do not treat their ground water
sources to monitor their ground water
source and to take corrective actions
when fecal contamination or a
significant  deficiency is found.
  In addition, EPA has evaluated data
on outbreaks and the occurrence of
waterborne viral and bacterial
pathogens and indicators of fecal
contamination in ground water
supplying PWS wells. These data
indicate that there is a subset of GWSs
that are susceptible to fecal
contamination; therefore, EPA believes
that risk management strategies are
needed to protect public health.
Specifically, the Centers for Disease
Control and Prevention (CDC) reports
that between 1991 (the year in which
the TCR became effective) and 2000,
GWSs were associated with 68
waterborne disease outbreaks that
caused 10,926 illnesses (Moore et al.
(1993); Kramer et al. (1996); Levy et al.
(1998); Barwick et al. (2000); and Lee et
al. (2002)). These outbreaks accounted
for 51 percent  of all waterborne disease
outbreaks in the United States during
that time period. The major deficiencies
identified by the CDC report as the
likely cause of the outbreaks were
source water contamination and
inadequate treatment (or treatment
failures); see Section III.C.2 for a
summary of these outbreak data. Studies
of viral and bacterial pathogens and/or
fecal indicator occurrence in ground
waters that supply PWSs show that
dozens of the public ground water wells
sampled  had fecal indicator or viral
presence in their wells. See Section
III.C.3 of this preamble for a summary
of occurrence  studies. Based on these
outbreak and occurrence data, along
with concern about lack of monitoring
and follow-up actions for GWSs, EPA
has concluded that GWSs need to
implement targeted, risk management
strategies to protect public health from
bacterial  and viral pathogens in fecally
contaminated  ground water sources.
  To provide a flexible, risk-targeted
approach to achieve public health
protection, this rule builds on existing
State programs—some that emphasize
the importance of disinfection and
others that emphasize assessments and
technical assistance—to identify and
target susceptible GWSs. In addition,
the GWR establishes treatment
technique requirements, which  provide
public GWSs with multiple options to
correct source water fecal contamination
and significant deficiencies that present
a public health risk. Furthermore, this
rule establishes compliance monitoring
requirements to ensure that treatment
effectiveness is maintained.

B. What Does  the GWR Require?
  The GWR establishes a risk-targeted
approach to identify GWSs susceptible
to fecal contamination and requires
corrective action to correct significant
deficiencies and source water fecal
contamination in public GWSs. A
central objective of the GWR is to
identify the subset of ground water
sources that are at higher risk of fecal
contamination among the large number

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           Federal  Register/Vol.  71, No.  216/Wednesday, November  8, 2006/Rules  and Regulations    65577
of existing GWSs (approximately
147,000), and then further target those
systems that must take corrective action
to protect public health. This risk-
targeting strategy includes the
following:
  • Regular GWS sanitary surveys to
check for significant deficiencies in
eight key operational areas;
  • A flexible program for identifying
higher risk systems through existing
TCR monitoring and State
determinations; and
  • Ground water source monitoring to
detect fecal contamination at targeted
GWSs that do not provide 4-log
treatment of viruses.
  Measures  to protect public health
include the following:
  • Treatment technique requirements
to address sanitary survey significant
deficiencies and fecal contamination in
ground water; and
  • Compliance monitoring to ensure
that 4-log treatment of viruses is
maintained where it is used to comply
with this rule.
  To meet the treatment technique
requirements of this rule, GWSs with a
significant deficiency or evidence of
source water fecal contamination,
following consultation with their
primacy agency (herein referred to  as
"the State"), must implement one or
more of the following corrective action
options: Correct all significant
deficiencies; provide an alternate source
of water; eliminate the source of
contamination; or provide treatment
that reliably achieves at least 99.99
percent  (4-log) treatment of viruses
(using inactivation, removal, or a State-
approved combination of 4-log virus
inactivation and removal) for each
ground water source. Each of these
corrective actions is intended to remove
all or nearly all fecal contamination,
including both viral and bacterial
pathogens. In addition, the GWS must
inform its customers of any uncorrected
significant deficiencies or fecal
indicator-positive ground water source
samples.
  The following sections provide more
detailed information on the provisions
of the GWR.

1. Sanitary Surveys
  Sanitary surveys are an important tool
for identifying potential vulnerabilities
to fecal contamination at GWSs. The
final GWR includes Federal sanitary
survey requirements for all GWSs for
the first time. This rule requires States,
as a condition for primacy, to perform
regular comprehensive sanitary surveys
of the following eight critical
components to the extent that they
apply to the  individual water system
being surveyed: (1) Source; (2)
treatment; (3) distribution system; (4)
finished water storage; (5) pumps, pump
facilities, and controls; (6) monitoring,
reporting, and data verification; (7)
system management and operation; and
(8) operator compliance with State
requirements. This rule includes
conditions of primacy in 40 CFR part
142 under which States will have until
December 31, 2012 to complete the
initial sanitary survey cycle for
community water systems (CWSs),
except those that meet performance
criteria, and until December 31, 2014 to
complete the initial sanitary survey
cycle for all non-community water
system (NCWSs) and CWSs that meet
performance criteria (refer to Section
IV.A.I for crtieria). Following the initial
sanitary survey cycle, States must
conduct these surveys every three years
for CWSs (defined in § 141.2), and every
five years for all NCWSs and CWSs that
meet certain performance criteria as
discussed in Section IV.A.I.
  If a significant deficiency is identified
as a result of a sanitary survey, the
system must take corrective action. If
the system does not complete corrective
action within 120 days of receiving
notification from the State, or is not in
compliance with a State-approved
corrective action plan and schedule, the
system will be in violation of the
treatment technique requirements of
this rule.
  The final GWR sanitary survey
provision provides comprehensive and
effective public health protection by
specifying the scope and frequency of
sanitary surveys and by requiring
corrective action for systems with
significant deficiencies.

2. Source Water Monitoring
  This rule requires triggered source
water monitoring and provides States
with the option to require assessment
source water monitoring. Source water
monitoring is an effective tool to target
at-risk systems that must take corrective
action to protect public health.
Indications of risk  may come from total
coliform monitoring, hydrogeologic
sensitivity analyses, or other system-
specific data and information.
  In this rule, a GWS with a distribution
system TCR sample that tests positive
for total coliform is required to conduct
triggered source water monitoring to
evaluate whether the total coliform
presence in the distribution system is
due to fecal contamination in the
ground water source. A GWS that does
not provide at least 4-log treatment of
viruses must conduct triggered source
water monitoring upon being notified
that a TCR sample  is total coliform-
positive. Within 24 hours of receiving
the total coliform-positive notice, the
system must collect at least one ground
water sample from each ground water
source (unless the GWS has an
approved triggered  source water
monitoring plan that specifies the
applicable source for collecting source
samples). The GWS must test the
ground water source sample(s) for the
presence of one of three State-specified
fecal indicators (E. coli, enterococci, or
coliphage). If the source sample is fecal
indicator-positive, this rule requires the
GWS to notify the State and the public.
Unless directed by the State to take
immediate corrective action, the GWS
must collect and test five additional
source water samples for the presence of
the same State-specified fecal indicator
within 24 hours. If any one of the five
additional source water samples tests
positive  for the State-specified fecal
indicator (E. coli, enterococci, or
coliphage), this rule requires the GWS to
notify the State and the public and
comply with the treatment technique
requirements, which require the system
to take one of four corrective actions
discussed in the following section. The
compliance date of  the triggered source
water monitoring requirement is
December 1, 2009.
  As a complement to the triggered
source water monitoring provision,
States have the option of requiring
GWSs to conduct assessment source
water monitoring. This flexible
provision gives States the opportunity to
target higher risk GWSs for additional
source water monitoring and evaluation.
The State may require a GWS to conduct
assessment source water monitoring as
needed. EPA recommends that States
use Hydrogeologic Sensitivity
Assessments (HSAs) and TCR/triggered
source water monitoring results, along
with other information to identify
higher risk systems  for assessment
source water monitoring. For
assessment source water monitoring,
EPA recommends that GWSs take 12
monthly samples and test them for one
of the GWR indicators (E. coli,
enterococci, or coliphage). Corrective
action for systems performing
assessment source water monitoring is
determined by the State.

3. Treatment Technique Requirements
  This rule requires a GWS to comply
with the treatment technique
requirements if a significant deficiency
is identified during  a sanitary survey.
Also, the rule requires a GWS to comply
with the treatment technique
requirements if one  of the five
additional ground water source samples
(or at State discretion, the initial source

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65578   Federal Register/Vol.  71,  No. 216/Wednesday, November  8, 2006/Rules and Regulations
sample) has tested positive for fecal
contamination (i.e., the sample is
positive for one of the three fecal
indicators and is not invalidated by the
State). The treatment technique requires
that a GWS implement at least one of
the following corrective actions: correct
all significant deficiencies; provide an
alternate source of water; eliminate the
source of contamination; or provide
treatment that reliably achieves at least
4-log treatment of viruses. Furthermore,
the GWS must inform the public served
by the water system of any uncorrected
significant deficiencies and/or fecal
contamination in the ground water
source. The compliance date of the
treatment technique requirements is
December 1, 2009.

4. Compliance Monitoring
  Compliance monitoring requirements
are the final defense against viral and
bacterial pathogens provided by this
rule. All GWSs that provide at least 4-
log treatment of viruses using chemical
disinfection, membrane filtration, or a
State-approved alternative treatment
technology must conduct compliance
monitoring to demonstrate treatment
effectiveness. The compliance date of
the compliance monitoring requirement
is December 1, 2009.
C. How Has the Final Rule Changed
From What EPA Proposed?
  The primary elements  of the proposed
GWR were sanitary surveys, triggered
monitoring, HSAs, routine monitoring,
corrective action, and compliance
monitoring. EPA received numerous
comments on the proposed GWR and
has carefully considered those
comments in developing the final GWR.
This consideration has led to a number
of changes that the Agency believes will
result in a more flexible, more targeted,
more protective final GWR.
  Most of the changes are minor and are
discussed throughout this preamble in
the pertinent sections. The most
significant change from the proposed
rule to the final rule is to the routine
monitoring provision. The proposed
routine monitoring provision would
have required GWSs in sensitive
aquifers, as defined by a  State
performed HSA, to collect monthly
source water samples.
  EPA received many negative
comments on the HSA provision. Some
States said that the proposed GWR did
not allow sufficient time to conduct the
HSA prior to the start of  routine
monitoring, which would result in
GWSs in non-sensitive aquifers being
required to monitor. Others stated that
they would not do the HSA; rather, they
would require all GWSs to conduct
routine monitoring. In addition, EPA
received comments that the routine
monitoring provision was too
burdensome.
  If the HSA provision would not be
implemented in many States to target
the routine monitoring to systems in
sensitive aquifers that are most at risk,
then the Agency  agrees with the
commenters that the routine monitoring
provision would be overly burdensome.
This is because some systems, located in
non-sensitive aquifers, would be
conducting routine monitoring
unnecessarily. Moreover, EPA now
believes that it is more difficult to
capture contamination than estimated in
the proposal,  which further highlights
the importance of correctly identifying
systems for which source water
monitoring would be prudent.
Furthermore,  commenters strongly
supported revision of the GWR proposal
to maximize State flexibility and
discretion in making system-specific
decisions.
  Given the importance of correctly
targeting systems for source water
monitoring, in conjunction with the
State's desire  for enough flexibility to
ensure sensible decisions on a case-by-
case basis, EPA decided to redesign the
source water monitoring provision.
Accordingly, the final rule does not
include a national requirement for HSAs
and routine monitoring for systems in
sensitive aquifers. Rather, EPA
concludes that the States are in the best
position to assess which  systems would
most benefit from a source water
monitoring program. The final provision
is similar to routine  monitoring but is
now optional for States and has been
renamed assessment source water
monitoring. States argued in their
comments that the information available
to them from  other programs such as
source water assessments, wellhead
protection plans, and historical data
would be important factors to consider
when determining the need for source
water monitoring. Because States are
best  able to identify  higher risk systems,
the final GWR provides States with the
option to require GWSs to perform
assessment source water monitoring.
The  Agency finds the comments
received on the proposal to be
persuasive and to support the approach
in the final GWR.
  The purpose of the optional
assessment source water monitoring
requirement is to allow States to target
such monitoring to GWSs that the State
believes are at higher risk for fecal
contamination. States specifically
requested this flexibility and discretion
in their comments to EPA. The
flexibility of this provision provides
many benefits. First, it gives States the
ability to make case-by-case
determinations of the need for source
water monitoring. Given the variety of
aquifer and well conditions across the
United States and even within each
State, State programs make more sense
than a nationally-directed program.
Second, the optional assessment source
water monitoring requirement allows
States to require assessment source
water monitoring as needed. System
conditions change over time and the
ability of States to target this
requirement to a specific system and
time period will reduce burden and be
critical to protecting public health by
allowing States to focus attention on
problem systems. The lack of time
constraints will also allow States to
prioritize susceptibility assessments and
further target those systems most in
need.
  EPA recommends that States use
HSAs as one tool to identify high risk
systems for assessment source water
monitoring. HSAs can be an effective
screening tool to identify sensitive
hydrogeologic settings that transmit
water, and any pathogens in that water,
quickly from the surface to the aquifer.
States have other information available
to them to target high risk systems, such
as source water assessments, wellhead
protection plans, and historical
monitoring data. Data on past
indications of source water fecal
contamination, particularly from TCR
monitoring, in combination with GWR
triggered source water monitoring
results, can be another important tool.

D. Does This Regulation  Apply to My
Water System?
  The requirements in this final rule
apply to all PWSs (CWSs and NCWSs)
that use ground water sources, in whole
or in part (including consecutive
systems that receive finished ground
water from another PWS), except that
they do not apply to PWSs that combine
all of their ground water with surface
water or ground water under the direct
influence of surface water (GWUDI)
prior to treatment under the Surface
Water Treatment Rule (SWTR) (54 FR
27486, June 29, 1989) (USEPA, 1989b).
The GWR ensures that the same  level of
public health protection is provided to
persons served solely by GWSs as to
those served by mixed systems supplied
by both ground water and surface water
sources. See Section V.A of this
preamble for more information on
mixed systems.

III. Background
  This section includes a discussion of
the statutory requirements, regulatory

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           Federal Register/Vol. 71, No.  216/Wednesday,  November 8,  2006/Rules  and Regulations   65579
 history, stakeholder involvement, and
 the public health concerns that this rule
 addresses.
 A. What Is the Statutory Authority for
 the GWR?
  Section 1412(b)(8) of the SDWA, as
 amended on August 6, 1996, requires
 EPA to promulgate National Primary
 Drinking Water Regulations (NPDWRs)
 requiring disinfection as a treatment
 technique for all PWSs, including
 surface water systems and, as necessary,
 GWSs. In addition, section 1412(b)(8) "
 requires EPA to promulgate criteria as
 part of the regulations for determining
 whether disinfection should be required
 as a treatment technique for any PWS
 served by ground water. In contrast, the
 1986 Amendments to the SDWA
 directed EPA to promulgate regulations
 requiring disinfection at all PWSs using
 either surface water or ground water.
 The SWTR implemented that
 requirement for surface water systems,
 but when Congress amended the SDWA
 again in 1996, EPA had not promulgated
 regulations requiring disinfection for
 PWSs that use ground water. In the
 legislative history of the 1996
 Amendments to the SDWA, Congress
 identified several reasons for the delay,
 including the recognition that not all
 GWSs are at risk of contamination, as
 well as the high cost of across-the-board
 disinfection. This rule implements
 section 1412(b)(8) of the SDWA, as
 amended, by establishing a regulatory
 framework for determining which GWSs
 are susceptible to fecal contamination
 and requiring those systems to
 implement corrective action options,
 only one of which is to provide 4-log
 treatment of viruses (e.g.,  disinfection).
  Section 1413(a)(l) of the SDWA
 allows EPA to grant a State primary
 enforcement responsibility ("primacy")
 for NPDWRs when EPA has determined
 that the  State has adopted regulations
 that are no less stringent than EPA's. To
 obtain primacy for this rule, States must
 adopt comparable regulations within
two years of EPA's promulgation of the
 final rule, unless EPA grants the State a
 two-year extension.  State  primacy
requires, among other things, adequate
enforcement (including monitoring  and
 inspections) authority and reporting
 requirement. EPA must approve or deny
 State primacy applications within 90
 days of submission to EPA (SDWA
section 1413(b)(2)). In some cases, a
 State submitting revisions to adopt an
NPDWR has primacy enforcement
authority for the new regulation while
EPA's decision on the revision is
pending (SDWA section 1413(c)).
Section 1445 of the SDWA authorizes
the Administrator to establish
monitoring, recordkeeping, and
reporting regulations to assist the
Administrator in determining
compliance with the SDWA and in
advising the public of the risks of
unregulated contaminants. Section 1450
of the SDWA authorizes the
Administrator to prescribe such
regulations as are necessary or
appropriate to carry out his or her
functions under the Act.

B. What Is the Regulatory History of the
GWR and How Were Stakeholders
Involved?
  EPA has devoted a tremendous effort
to engage stakeholders in the
development of the GWR. EPA began
developing the GWR in 1987 to address
potential fecal contamination of GWSs
by requiring across-the-board
disinfection, as directed by the 1986
Amendments to the SDWA. A
preliminary public meeting on  issues
related to GWSs was held in 1990 (55
FR 21093, May 22, 1990) (USEPA,
1990). By 1992, EPA had developed a
draft proposed rule that would  have
required disinfection for all GWSs  (57
FR 33960, July 31,  1992) (USEPA, 1992).
The draft proposed rule incorporated
stakeholder input and was made
available for stakeholder review. While
some stakeholders  supported the
increased public health protection  for
people drinking ground water,  most
stakeholders were concerned that the
rule was crafted such that all GWSs
were assumed to be contaminated until
monitoring proved otherwise and that
disinfection waivers would be difficult
to obtain.
  Throughout the early and mid-1990s,
EPA conducted technical discussions
with ad hoc working groups during
more than 50 conference calls, with
participation of EPA Headquarters, EPA
Regional offices, States, local
governments, academicians, and trade
associations. In 1996, Congress
amended the SDWA and required EPA,
under section 1412(b)(8), to develop
regulations requiring disinfection as a
treatment technique for GWSs "as
necessary." As discussed previously,
this Amendment to the SDWA called for
a different regulatory framework to
address fecal contamination in  GWSs. In
light of this statutory change in
direction, EPA determined that further
stakeholder involvement would be
crucial to establishing an effective
approach for regulating fecal
contamination in PWSs that use ground
water sources.
  Technical meetings were held in
Irvine, California in July 1996 (USEPA,
1996), and in Austin, Texas in March
1997 (USEPA, 1997a). These technical
discussions focused primarily on
establishing a reasonable means for
determining if a ground water source
was vulnerable to fecal contamination.
EPA evaluated the possibility of
developing a  vulnerability assessment
tool that would consider hydrogeologic
information and sources of fecal
contamination.
  In addition, EPA held a series of
stakeholder meetings (in Portland, OR;
Madison, WI; Dallas, TX; Lincoln, NE;
and Washington, DC) designed to
engage all stakeholders in developing a
risk-based regulatory framework. The
purpose of these meetings was to review
available information on risk and to
discuss methods to identify GWSs that
are susceptible to  fecal contamination,
and therefore, should be required to take
corrective actions. EPA also held three
early involvement meetings with State
representatives (in Portland, OR;
Chicago, IL; and Washington, DC) and
received valuable  input from small
system operators as part of an Agency
outreach initiative under the Small
Business Regulatory Enforcement
Fairness Act.  Over the course of these
stakeholder meetings, the participants
evaluated a continuum of regulatory
approaches. The meetings fostered
EPA's understanding of how State
strategies fit together as a part of a
national strategy. Taken together, the
meetings were crucial in guiding the
Agency's development of regulatory
components for the GWR proposal.
  On February 3, 1999, EPA distributed
a preliminary draft preamble using the
approach developed during the
stakeholder meetings. Eighty individual
comment letters were received from
representatives of State and local
governments, trade associations,
academic institutions, individual PWSs,
and other Federal  agencies. EPA
considered all of the comments received
from this informal process  as the
Agency revised the draft proposal.
  The proposed GWR was published in
the Federal Register in 2000 (65 FR
30194, May 10,  2000) (USEPA, 2000a).
The comment period closed on August
9, 2000, and EPA received comments
from over 250 individuals,  corporations,
organizations, PWSs, States and Tribes,
industry and trade associations, and
environmental groups. EPA has
carefully considered all of these
comments in developing this final rule.
Comments received on the  proposed
rule, along with EPA's responses, are
compiled in the Public Comment and
Response Document for the Final
Ground Water Rule (USEPA, 2006c).
  EPA published a Notice of Data
Availability (NODA) in the Federal
Register in 2006 (71 FR 15105, March

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65580   Federal Register/Vol.  71, No. 216/Wednesday,  November 8,  2006/Rules  and Regulations
27, 2006) (USEPA, 2006e). The purpose
of the NODA was to present additional
studies that the Agency was considering
in conducting its economic analysis for
the final rule. The comment period
closed on April 26, 2006. EPA received
14 sets of comments from individuals,
trade associations, State and local
governments, an organization, and a
university. Comments received on the
NODA, along with EPA's responses, are
also compiled in the Public Comment
and Response Document for the Final
Ground Water Rule (USEPA, 2006c).
C. What Public Health Concerns Does
the GWR Address?
  This section explains the public
health concerns associated with fecal
contamination in  GWSs by summarizing
information on how ground water
sources could become fecallv
contaminated, the causes of ground
water outbreaks, and the health effects
of consuming contaminated water.
1. Introduction
  EPA estimates that approximately 114
million people consume drinking water
from PWSs that use ground water
sources (Table III-l). These PWSs (total
of about 147,000) distribute disinfected
or undisinfected ground water to their
customers. Approximately 18 percent
(20 million) of people served by PWSs
that use ground water sources receive
undisinfected water, while over 60
percent (70 million) receive either
undisinfected water or water treated to
less than  4-log inactivation or removal
of viruses.
  Over 100 million people receive
ground water from community water
systems (CWSs) (Table III-l), while
about 14 million people receive ground
water from non-community water
systems (NCWSs); non-transient non-
community water systems (NTNCWSs)
serve ground water to about five million
people and transient non-community
water systems (TNCWSs) serve ground
water to about nine million people.
Table III-l shows that, of the number of
people receiving water from CWSs,
NTNCWSs, and TNCWSs,
approximately 9.3 million (9.2 percent),
3.6 million (71 percent), and 7.2
million, (83 percent), respectively,
receive water that is not disinfected at
all. The Table also shows that 56.8
million people served by CWSs, 4.7
million people served by NTNCWSs,
and 8.6 million people served by
TNCWSs receive water that is either
undisinfected or treated to less than 4-
log.
                          TABLE 111-1.—POPULATION SERVED BY GROUND WATER SYSTEMS
                                                      [Millions]

CWSs 	
NTNCWSs 	
TNCWSs 	
Total population
served by ground
water systems
1004
5 1
8.7
Population served
untreated ground
water
93
36
7.2
Population served
ground water that is
either undisinfected
or treated to less
than 4-log
568
47
8.6
  Source: Exhibit 4.4 of the GWR EA (USEPA, 2006d).
  As discussed previously in Section
II.A, the CDC identified source water
contamination and inadequate treatment
as the major causes for ground water-
related outbreaks between 1991 and
2000. Untreated or inadequately treated
ground water may contain viral and
bacterial pathogens. Therefore,
undisinfected ground water or water
treated to less than 4-log may pose a
public health risk to consumers.
  Waterborne disease attributable to
viral and bacterial pathogens is a
significant public health problem. EPA's
Science Advisory Board cited drinking
water contamination, particularly
contamination by pathogenic
microorganisms, as one of the most
important environmental risks (USEPA/
SAB, 1990). The CDC reports significant
numbers of recent waterborne disease
outbreaks and cases of illness associated
with ground waters (Moore et al. (1993);
Kramer et al. (1996); Levy et al. (1998);
Barwick et al. (2000); Lee et al. (2002)).
  Most waterborne pathogens, including
viral and bacterial pathogens, cause
gastrointestinal (GI) illness with
diarrhea, abdominal discomfort, nausea,
vomiting, and other symptoms. The
effects of a waterborne disease are
usually acute, resulting from a single
exposure. Most GI illnesses are
generally of short duration and result in
mild illness, but  some can result in
severe illness and even death. For
example, during  a recent ground water
outbreak in New York, a healthy three-
year old child died from hemolytic
uremic syndrome (kidney failure) (New
York State Department of Health, 2000).
Waterborne pathogens also cause other
serious disorders such as hepatitis,
Legionnaires Disease, myocarditis,
paralysis, acute hemorrhagic
conjunctivitis, meningitis, and reactive
arthritis. Waterborne pathogens have
also been associated with diabetes,
encephalitis, and other diseases
(Lederberg, 1992).
  Sensitive populations are at greater
risk from waterborne disease from  viral
and bacterial pathogens than the general
population. These sensitive
subpopulations include children
(especially the very young); the elderly;
the malnourished; pregnant women;
chronically ill  patients (e.g., those  with
diabetes or cystic fibrosis); and a broad
category of those with compromised
immune systems, such as AIDS patients,
those with autoimmune disorders (e.g.,
rheumatoid arthritis, lupus
erythematosus, and multiple sclerosis),
organ transplant recipients, and those
receiving chemotherapy (Rose, 1997).
Sensitive subpopulations (or those with
compromised immune systems)
represent almost 20 percent of the
population in the United States (Gerba
et al., 1996). The severity and duration
of illness is often greater in sensitive
subpopulations than in healthy
individuals, and may occasionally result
in death.
  When humans are exposed to and
infected by an enteric pathogen, such as
a bacterium or virus, 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, etc.), which is
referred to as secondary spread.

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           Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations    65581
Waterborne pathogens thus may infect
people via a variety of routes.
  Fecal contamination of drinking water
is a primary cause of waterborne disease
(Szewzyk et al., 2000). Viral and
bacterial  pathogens associated with
fecal contamination can reach ground
water via pathways in the subsurface
and near surface. First, fecal
contamination from, for example,
improper storage or management of
manure, runoff from land-applied
manure, leaking sewer lines, or failed
septic systems can reach the ground
water source by traveling—sometimes
great distances—through the subsurface
(especially through transmissive
materials such as karst, gravel, or
fractured bedrock). Twenty-five million
households in the United States use
conventional  onsite wastewater
treatment systems, according to the
1990 Census.  These systems include
septic systems and  leach fields. A
national estimate of failure rates of these
systems is not available; however, a
National  Small Flows Clearinghouse
survey reports that in 1993 alone,
90,632 failures were reported (USEPA,
1997b). The volume of septic tank waste
alone that is released into the subsurface
has been  estimated at one trillion
gallons per year (Canter and Knox,
1984). This contamination may
eventually reach the intake zone of a
drinking water well.
  Second, fecal contamination from the
surface may enter a drinking water well
along the casing or through cracks in the
sanitary seal if it is not properly
constructed, protected, or maintained.
In addition to source contamination,
fecal contamination may also enter the
distribution system when cross-
connection controls fail or when
negative  pressure in a  leaking pipe
allows contaminant infiltration. A
subset of GWSs is susceptible to
contamination by one  or more of these
routes.

2. Waterborne Disease Outbreaks in
Ground Water Systems

  The Centers for Disease Control  and
Prevention (CDC) reports that between
1991 (the year in which implementation
of the TCR began) and 2000, GWSs (both
CWSs and NCWSs) were associated
with 68 outbreaks that caused 10,926
illnesses  (Table III—2).  These account for
51 percent of all waterborne disease
outbreaks in the United States during
that period. The outbreak data illustrate
that the major deficiency in GWSs was
source water contamination.
Contaminated source water was the
cause of 79 percent of the outbreaks in
GWSs (63 percent of CWS outbreaks and
86 percent of NCWS outbreaks), shown
as untreated ground water and treatment
deficiencies in Table III-2. Consumers
of undisinfected water are especially
vulnerable to source water
contamination.  Approximately 70
percent of GWSs provide either
untreated ground water or provide
treatment of less than 4-log virus
inactivation or removal as discussed in
the GWR EA (USEPA,  2006d).
  Of the 68 outbreaks in GWSs,  14 (21
percent) were associated with specific
bacterial pathogens (see Table III-3).
The fecal bacterial  pathogen Shigella
caused more reported outbreaks (five,
seven percent) than any other bacterial
agent. Identified viral pathogens were
associated with four (six percent)
reported outbreaks. Etiologic agents
were not identified in  39 (57 percent)
outbreaks; however, EPA suspects that
many of these outbreaks were caused by
viruses given that it is  generally  more
difficult to analyze for viral pathogens
than bacterial pathogens. EPA regulates
for protozoa, including Giardia and
Cryptosporidium, under the SWTRs,
which also cover GWUDI systems. For
the most part, the outbreaks associated
with protozoa that  occurred in GWSs
were later determined  by the State to be
GWUDI systems.
BILLING CODE 6560-50-P

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 65582   Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations

        Table III-2:  Sources of Waterborne Disease Outbreaks in Ground Water Systems, 1991 -
        2000
Cause of Contamination
Number of
Outbreaks
Percent
Outbreaks
Cases of
Illness
Percent
Illnesses
Cases
per
Outbreak
Community Water Systems
Untreated Ground Water
Treatment Deficiency
Distribution System Deficiency
Miscellaneous/Unknown
Total
5
7
5
2
19
26%
37%
26%
11%
100%
167
K624
803
183
2,777
6%
58%
29%
7%
100%
33
232
161
92
146
Noncommuniry Water Systems
Untreated Ground Water
Treatment Deficiency
Distribution System Deficiency
MiscellaneousAJnknown
Total
23
19
6
1
49
47%
39%
12%
2%
100%
4.057
3,264
442
386
8,149
50%
40%
5%
5%
100%
176
172
74
386
166
Combined
Untreated Ground Water
Treatment Deficiency
Distribution System Deficiency
Miscellaneous/Unknown
Total
28
26
11
3
68
41%
38%
16%
4%
100%
4,224
4,888
1,245
569
10,926
39%
45%
11%
5%
100%
151
188
113
190
161
       Sources: Moore et al. (1993); Kramer et al. (1996); Levy et al. (1998); Banvick et al. (2000); and Lee et al. (2002).
       Table III-3: Etiology of Waterborne Outbreaks in Ground Water Systems, 1991-2000



Causative Agent
Protozoa
Giardia
Cryptosporidium
Virus
Hepatitis A
Nonvalk Virus
Bacteria
Shigella
Campy/obacter
Salmonella, non-typhoid
S. lyphimurium
E. coli
Vibrio
Undetermined
Total



Outbreaks
8
5
3
-
-
-
6






5
19
CWSs

Cases of
Illness
1,675
136
1,539
-
-
-
1,037
83
172
625
124
22
11
65
2,777

Percent of
Total
Outbreaks
42.1%
26.3%
15.8%
0.0%
0.0%
0.0%
31.6%
5.3%
5.3%
5.3%
5.3%
5.3%
5.3%
26.3%
100.0%



Outbreaks
3
2
1
4
-
4
8
4
2
-
-
2
-
34
49
NCWSs

Cases of
Illness
576
25
551
1,806
-
1,806
1,309
473
51
-
-
785
-
4,458
8,149

Percent of
Total
Outbreaks
6.1%
4.1%
2.0%
8.2%
0.0%
8.2%
16.3%
8.2%
4.1%
0.0%
0.0%
4.1%
0.0%
69.4%
100.0%



Outbreaks
11
7
4
4
-
4
14
5
3
1
1
3
1
39
68
TOTAL

Cases of
Illness
2,251
161
2,090
1,806
-
1,806
2,346
556
223
625
124
807
11
4,523
10,926

Percent of
Total
Outbreaks
16.2%
10.3%
5.9%
5.9%
0.0%
5.9%
20.6%
7.4%
4.4%
1.5%
1.5%
4.4%
1.5%
57.4%
100.0%
       Note: Detail may not add to totals due to independent rounding.
       Sources: Moore et al. (1993); Kramer et al. (1996); Levy et al. (1998); Banvick et al. (2000); and Lee et al. (2002).
BILLING CODE 6560-SO-C

  Large outbreaks are rarely associated
with GWSs because most GWSs are
small. In addition, the number of
identified and reported outbreaks in the
CDC database is believed to
substantially understate the actual
incidence of waterborne disease
outbreaks and cases of illness (Craun
and Calderon, 1996; National Research
Council, 1997). This underestimation is
due to a number of factors. Many people
experiencing gastrointestinal illness do
not seek medical attention. Where
medical attention is provided, testing to
identify the pathogenic agent is often
not done and even if it is, the
pathogenic agent may not be identified
through correct testing (e.g., when a
sample is tested for a limited number of
pathogens). Physicians often lack
sufficient information to attribute
gastrointestinal illness to any specific
origin, such as drinking water, and few

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                                                                                                             65583
States have an active outbreak
surveillance program. Furthermore, the
outbreak reporting system in the U.S. is
paper-based and voluntary.
Consequently, waterborne disease
outbreaks are often not recognized in a
community or, if recognized, are not
traced to a drinking water source even
though it may be the cause of the
outbreak. Although it occurred in a
community served by a surface water
source, the 1993 Cryptosporidium
outbreak in Milwaukee, Wisconsin is an
example of how difficult it is to
recognize a drinking waterborne disease
outbreak. In one study of this  large
outbreak, only six percent sought health
care and only six percent of those health
care cases were tested for parasites (with
only four percent of those cases
specifically tested for Cryptosporidium)
(Juranek, 1997). Thus, over 99 percent of
estimated cases of illness went
undiagnosed in this outbreak. In
addition to epidemic illness, an
unknown but probably significant
portion  of waterborne disease is
endemic (i.e., isolated cases not
associated with an  outbreak) and is even
more difficult to recognize.
  Collectively, the  data indicate that
outbreaks in GWSs are a problem and
that source water contamination and
inadequate treatment (or treatment
failures) are responsible for the great
majority of outbreaks.

3. Microbial Contamination in Public
Ground Water Systems
  The extent to which viral and
bacterial pathogens occur in public
ground water supplies influences the
risk of exposure to  populations
consuming ground water from PWSs.
Such risks of exposure pertain to
populations using both undisinfected
and disinfected water supplies. For
undisinfected supplies, pathogens in the
water are an immediate risk, since no
treatment barrier exists prior to
consumption. For disinfected  supplies,
if disinfection  is inadequate or if
treatment plant upsets occur, pathogens
can reach consumers. These exposure
risks were discussed in Section III.C.2
from an outbreak perspective.  This
section will discuss data on the
occurrence of waterborne viral
pathogens and indicators of fecal
contamination in ground water
supplying PWS wells.
  a. Occurrence studies and data. For
this rule, EPA examined the occurrence
of viral pathogens and some fecal
indicators. EPA reviewed data from 24
studies on pathogen and fecal  indicator
occurrence in ground water wells that
supply PWSs. This total includes 16
studies described in the proposal, seven
                             studies that became available since
                             proposal as described in the NODA
                             (USEPA, 2006e), and one study that was
                             provided to EPA in comment as a result
                             of the NODA. Each study was
                             conducted independently and with a
                             different objective and scope. The
                             Occurrence and Monitoring Document
                             for the Final Ground Water Rule
                             (USEPA, 2006b) provides a detailed
                             discussion of each examined occurrence
                             study. The available data show  a wide
                             range of enterovirus and fecal indicator
                             occurrence in water drawn from wells
                             across the U.S. EPA selected 15 studies
                             to estimate national viral and fecal
                             indicator occurrence in ground  water.
                             To arrive at the conclusion that these 15
                             studies provide the best possible
                             representation of ground water
                             contamination at a national level, EPA
                             evaluated all available studies (24
                             studies) that were applicable to the risk
                             assessment analyses (USEPA, 2006d).
                             See Section VII.B.I of this preamble for
                             a discussion of study selection.
                              Enterovirus cell culture data from the
                             15 studies  were used to estimate the
                             baseline risk related to virus occurrence
                             in ground water. EPA believes that
                             enterovirus cell culture measurements
                             provide the best available basis  for
                             estimating pathogenic viral occurrence
                             since they  capture viruses that are
                             infectious. However, because the cell
                             culture  procedure only captures a
                             portion of all viruses that may actually
                             occur in well water due to assay
                             limitations, use of this method may
                             underestimate viral occurrence.
                              EPA used data on the indicator E.  coli
                             from these same studies to inform
                             estimates of fecal contamination
                             occurrence. Indicator data are important
                             because illness can result from
                             consuming ground water with fecal
                             contamination in the absence of
                             identified viruses. For example, some
                             viruses  such as infectious norovirus are
                             not recoverable, other viruses such as
                             enteroviruses have variable and limited
                             recovery, and a variety of bacteria of
                             fecal origin can cause disease. EPA
                             chose to use E. coli data instead of other
                             fecal indicator data for this analysis.
                             This choice was driven by EPA's
                             assessment that E. coli will be the most
                             likely fecal indicator used when PWSs
                             implement the GWR, because E. coli is
                             frequently used to fulfill follow-up
                             monitoring requirements under  the
                             TCR.  Therefore national estimates of E.
                             coli occurrence can be used to inform
                             potential cost implications for
                             implementing the GWR. EPA recognizes
                             that any indicator organism, including
                             E. coli, may or may not co-occur with
                             pathogens and that co-occurrence could
                             be intermittent. E. coli is an imperfect
indicator of viral occurrence. Some
wells with E. coli have no viral
occurrence. Some wells with viral
occurrence have no E. coli.
  b. Estimates of national occurrence of
viral and fecal indicator contamination.
This section discusses national
occurrence of viral and fecal indicator
(E. coli) contamination, which includes
estimates of viral concentrations in
contaminated wells and estimates of the
probability that a well may have
detectable viral and/or fecal  indicator
contamination. For purposes of this
analysis, EPA uses the term "sometime
contamination" as contamination that
occurs at one or more points in time.
Because fecal contamination is
intermittent, viruses and E. coli will
only be present at detectable levels
some fraction of the time in a
contaminated well. These fractions will
vary from well to well. Some wells may
be frequently contaminated but  others
may only be contaminated for a small
fraction of time.
  EPA analyzed the 15 studies for data
to inform the concentration analysis.
Among the 15 studies used for the
national occurrence analysis, 12
provided data on occurrence of
enterovirus cell culture and 11 provided
data on occurrence of E.  coli. Among the
12 data sets with enterovirus cell
culture measurement, three included
viral concentration data. Concentration
measurements in the three surveys
ranged from 0.09 to 212 enteric virus
infectious units (plaque forming units)
per 100 liters. Although the
measurement methods were often not
capable of detecting viruses at
concentrations below 0.2 units per 100
liters, it is likely that viruses also occur
at levels below the detection limit.
  Data from each of the 15 studies were
combined into one complete data set to
determine the probabilities of sometime
well contamination for viral  (indicated
by enterovirus cell culture) or fecal
indicator (indicated by E. coli)
contamination. The results of this effort
led naturally to a combined analysis,
which models occurrence and co-
occurrence of viruses and E.  coli. EPA's
analysis also considers uncertainty and
variability about these estimates. The
model serves  as the basis of EPA's
national quantitative occurrence
estimates. See the Occurrence and
Monitoring Document for the Final
Ground Water Rule for more
information (USEPA, 2006b).
  Overall, the analysis indicates a
public health concern in that
approximately 26 percent of the wells
sometimes have fecal contamination
(indicated by E. coli) and approximately
27 percent of the wells sometimes have

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65584   Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations
viral contamination. Due to the
intermittent nature of fecal
contamination, some of these wells are
only contaminated for a  small fraction
of time. On average, wells with
sometime virus occurrence have
detectable concentrations about 11
percent of the time, and  wells with
sometime E. coli occurrence have
detectable concentrations about 14
percent of the time. The  remainder of
the time, the well's water is essentially
virus free (assuming that concentration
is zero when not detected by
measurement methods like those used
in the occurrence studies). Compared to
the analysis in the proposal, the number
of wells with fecal contamination is
greater but the frequency at which
contamination occurs in each  well is
less.
  In summary, EPA's occurrence
analysis shows that fecal contamination
is intermittent and that some
individuals are at risk because
pathogens and/or fecal indicators occur
at PWSs that use ground water as a
source of drinking water. The  next
section discusses this risk.

4. Potential Risk  Implications  From
Occurrence Data
  As discussed previously, to assess the
public health risk associated with
drinking ground  water, EPA evaluated
information and  conducted analyses on
(1) Health effects data from a range of
pathogens, (2) waterborne disease
outbreak data, and (3) occurrence data
from ground water studies and surveys.
As a result of this evaluation and
analysis, EPA concludes that the
potential risk to public health posed by
a subset of PWSs with contaminated
ground water sources is  significant
enough to warrant regulation.
  When a PWS uses contaminated
source water, its  customers are at risk of
infection and illness. Their risk depends
on a number of factors including
whether the system provides at least 4-
log treatment of viruses, the frequency
at which the well is contaminated, the
level of contamination (i.e.,
concentration), and the infectivity of the
pathogens that are present.
  To develop risk estimates from viral
exposure, EPA considered two types of
viruses, Type A (represented by data
available on rotavirus) and Type B
(represented by data available on
enterovirus or echovirus), which are
used to estimate  risk from exposure to
viral-contaminated wells. These two
virus types have  different infection
morbidity and disease severity
characteristics. Type A viruses are
considered to be highly infectious but
cause primarily mild illness, while Type
B viruses are considered much less
infectious but may cause more severe
illnesses.
  The infectivity of a virus relates the
probability of infection to a given
amount, or dose, of virus consumed.
Together with infectivity, morbidity
(risk of illness given infection) and
mortality (risk of premature death given
an illness) are used to predict the
disease burden associated with a
particular virus level in drinking water.
As discussed in the previous section, a
typical contaminated well may have
detectable virus concentrations 11
percent of the time. The remainder of
the time, the well's water is essentially
virus free (assuming that concentration
is zero when not detected by
measurement methods  like those used
in the occurrence studies). EPA has viral
concentration data from the three
studies as discussed in  Section IILC.S.b
of this preamble. Virus  concentration
data  combined with viral exposure data
can be used to predict infection rates
given viral dose-response information.
Figure III—1 indicates the annual risk of
infection from exposure to rotavirus,
assuming one liter of water consumed
per day, based on a range of possible
mean annual source water
concentrations and different levels of
treatment. For example, if an untreated
ground water source had a mean annual
source water concentration of 0.1
viruses per 100 L (e.g., a source water
concentration of one virus per 100 L, 10
percent of the time), people consuming
one liter of this water per day would
have approximately a seven percent
probability of being infected in the
course of the year (90 percent
confidence interval of three percent  to
13 percent). The risk of infection
implications from exposure to echovirus
are 10 to 100 times less than those from
rotavirus, assuming the same levels of
exposure. However, illness resulting
from infection of echovirus may be more
severe than illness resulting from
infection by rotavirus.
  It is important to recognize that  EPA's
quantitative risk analysis is limited by
the data available, specifically data on
rotavirus and echovirus. Other
pathogenic viruses also cause disease
and may be more or less infectious than
those modeled. Pathogens may cause
chronic and acute illnesses in addition
to those considered in the quantitative
risk analysis. Furthermore, EPA's
quantitative risk analysis does not
consider bacterial illness and deaths
resulting from contaminated drinking
water due to limited data. Taken
together, these limitations imply an
underestimate of the actual illnesses
and deaths that result from exposure to
contaminated ground water when only
these sources of uncertainty are
considered. The GWR national risk
implications from exposure to
pathogenic viruses and bacteria are
discussed in Section VII of this
preamble and more fully discussed in
the GWR EA (USEPA, 2006d).
  Even at the levels EPA is able to
quantify, the risk analysis supports the
conclusion that a substantial number of
people served by GWSs are at risk of
exposure to waterborne pathogens.
EPA's occurrence analysis (USEPA,
2006b) demonstrates that some wells
have high viral occurrence while others
have lower occurrence, and thus lower
risk.  For public health protection, it is
most important to target those wells
with higher occurrence. In addition, the
occurrence analysis demonstrates that
contamination is intermittent. Because
of the intermittent nature of
contamination, an ongoing monitoring
program is critical to effectively target
higher risk systems.
  The intent of the GWR is to reduce
risk by targeting susceptible systems for
corrective action. The corrective action
options are: Correct all significant
deficiencies; provide an alternate source
of water; eliminate the source of
contamination; or provide treatment
that reliably achieves at least 4-log
treatment of viruses. As illustrated in
Figure III-l, treatment will provide
large improvements in public health.
Thus, the final GWR components of
sanitary surveys, source water
monitoring, and corrective action are
each critical steps to improving public
health in communities served by
undisinfected (or inadequately
disinfected) GWSs.
  Implementation of this rule is
expected to result in approximately
42,000 avoided viral illnesses and one
avoided death annually. The analysis is
uncertain and these estimates could be
an over-or under-estimate of actual
illnesses and  deaths. The nonqualified
benefits are those that the Agency was
unable to quantify due to data
limitations, which include decreased
incidence of other acute viral disease
endpoints, decreased incidence of
chronic viral  illness sequelae, decreased
incidence of bacterial illness and death,
decreased incidence of waterborne
disease outbreaks and epidemic illness,
and decreased illness through
minimizing treatment and distribution
system failures. The nonquantified
benefits associated with this rule are
significant and are discussed in detail  in
Section 5.4 of the GWR EA (USEPA,
2006d).

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          Federal Register/Vol.  71, No. 216/Wednesday, November  8, 2006/Rules and Regulations    65585

       Figure III-l: Estimated Annual Risks of Infection from Rotavirus for Different Exposure
       Conditions
         o
         ts
         I
0.01
               0.001
         Q.
         "5
              0.0001  -
             0.00001  -
                                      Ground Water Receivina 4-loa
            0.000001 -..
           0.0000001
                   0.01
                                                         — 90 percent confidence bounds around dose-
                             0.1                         1
                          Mean Well Water Concentration, per 100 L
                                                                                                  10
IV. Discussion of GWR Requirements
  This section describes the rule
requirements and rationale for each
component of the risk-targeted strategy
of this rule. A summary of, and
responses to, key comments on the
proposed rule are also provided.

A. Sanitary Surveys
  EPA believes that comprehensive,
periodic sanitary surveys and the
identification and correction of
significant deficiencies are
indispensable for ensuring the long-term
safety of drinking water supplies. They
                      are an important tool for identifying
                      potential vulnerabilities to fecal
                      contamination at GWSs. The final GWR
                      includes Federal requirements for
                      sanitary surveys of all GWSs for the first
                      time.
                        This rule provides the States with
                      flexibility to prioritize and carry out the
                      sanitary survey process, while ensuring
                      that the survey is an effective,
                      preventive tool for GWSs. The sanitary
                      survey provision in this rule builds on
                      existing State sanitary survey programs
                      established under the 1989 f CR and the
                      Interim Enhanced Surface Water
Treatment Rule (IESWTR) (63 FR 69477,
December 16, 1998) (USEPA, 1998b)
and gives States the authority to define
both outstanding performance and
significant deficiencies. At the same
time, the GWR's sanitary survey
requirements for minimum frequencies,
scope, documentation, and mandatory
corrective action strengthen existing
sanitary survey programs and address
many of the concerns associated with
current sanitary survey programs as
identified by the GA(D (USGAO, 1993).
BILLING CODE 6560-50-P

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65586   Federal Register/Vol.  71,  No. 216/Wednesday, November  8, 2006/Rules and Regulations

                 Figure IV-1: Sanitary Survey Requirements
                              State must conduct Sanitary Surveys at alt GWSs
                              CWS: Every 3 years (every 5 years if they meet
                              performance criteria)
                              NCWS: Every 5 years
                                 Sanitary Survey must cover 8 elements:
                                 (1)   Source
                                 (2)   Treatment
                                 (3)   Distribution system
                                 (4)   Finished water storage
                                 (5)   Pumps, pump facilities, and controls
                                 (6)   Monitoring, reporting, and data
                                      verification
                                 (7)   System  management and operation
                                 (8)   Operator compliance with State
                                      requirements
                                                                                       No
                                          Sanitary Survey identifies
                                           a significant deficiency?
                          State must do one of the following:
                          1.    Notify the GWS at the time of the Sanitary Survey, or
                          2.    Provide written notification within 30 days of the
                               Sanitary Survey
                                 • May specify corrective action in written notification
                                           Go to Section IV.C.1
BILLING CODE 6560-5O-C
1. What Are the Requirements of This
Rule?
  This rule requires States to perform
sanitary surveys for all GWSs. Ground
water systems must provide the State
with any pertinent, existing information
that will enable the State to perform the
sanitary survey. This rule goes beyond
the existing definition of sanitary survey
at § 141.2, explicitly references the use
and relevance of source water
assessments required  under the 1996
SDWA Amendments, and specifies in
more detail the scope of a sanitary
survey. Specifically, this rule requires
that States evaluate eight components as
part of the sanitary survey to the extent
that they apply to an individual system:
(1) Source; (2) treatment; (3) distribution
system; (4) finished water storage; (5)
pumps, pump facilities, and controls;
(6) monitoring, reporting, and data
verification; (7) system management and
operation; and (8) operator compliance
with State requirements. This rule
outlines the eight minimum elements
using broad categories and recognizes
that certain elements may not be present
in a particular system depending on its
size or complexity.
  This rule requires States to conduct
sanitary surveys of ground water CWSs
every three years (every five years for
CWSs that meet performance criteria as
described in the following paragraph)
and of ground water NCWSs every five
years. States are required to complete
the initial sanitary survey cycle by
December 31, 2012 for CWSs, except
those that meet performance criteria,
and December 31, 2014 for all NCWSs
and CWSs that meet performance
criteria. States may conduct more
frequent sanitary survey cycles for any
GWS as appropriate.
  This rule allows individual
components of a sanitary survey to be
conducted according to a phased review
process (e.g., as part of ongoing State
assessment programs). While all

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           Federal  Register/Vol.  71,  No. 216/Wednesday, November 8, 2006/Rules and Regulations    65587
applicable components need not be
evaluated at the same time, they must be
evaluated within the required three-or
five-year frequency interval. Also, this
rule allows the three-year CWS schedule
to be extended to a five-year frequency
if the system meets certain criteria
(referred to in  this  preamble as
"performance  criteria"). These
performance criteria are:
  •  Provides 4-log treatment of viruses
(using inactivation, removal, or a State-
approved combination of 4-log virus
inactivation and removal) before or at
the first customer for all its ground
water sources, or
  •  Has an outstanding performance
record (as defined  by the State)
documented in previous sanitary
surveys, and has no history of total
coliform MCL  or monitoring violations
under the TCR since the last sanitary
survey.
  Finally, this rule requires that GVVSs
correct any significant deficiencies
identified in sanitary surveys.
Significant deficiencies, as determined
by the  State, include, but are not limited
to, defects in design, operation, or
maintenance, or a failure or malfunction
of the sources, treatment, storage, or
distribution system that the State
determines to be causing, or have the
potential for causing, the introduction of
contamination  into the water delivered
to consumers.
  Significant deficiencies may include,
but are not limited to, the following:
  Source
  •  Well near a source of fecal
contamination  (e.g., failing septic
systems or a leaking sewer line).
  •  Well in a flood zone.
  •  Improperly constructed well (e.g.,
improper surface or subsurface seal).
  •  Spring boxes that are poorly
constructed and/or subject to flooding.
  Treatment
  •  Inadequate application of treatment
chemicals (e.g., disinfection contact
time is inadequate).
  •  Lack of redundant mechanical
components where disinfection is
required.
  •  Unprotected cross-connections with
treatment chemical systems.
  • Inadequate treatment process
monitoring.
  Distribution  System
  • Negative pressures that could result
in the entrance of contaminants.
  • Inadequate disinfectant residual
monitoring, when required.
  • Unprotected cross-connections.
  Finished Water Storage
  • Inadequate internal cleaning and
maintenance of storage tanks.
  • Lack of proper screening of
overflow pipes, drains, or vents.
  •  Storage tank roofs or covers need
repair (e.g., holes or hatch of improper
construction).
  Pumps, Pump Facilities, and Controls
  •  Inadequate pump capacity.
  •  Inadequate maintenance.
  •  Inadequate/inoperable control
system.
  Monitoring, Reporting, and Data
Verification
  •  Failure to properly monitor water
quality.
  •  Failure to meet reporting
requirements.
  •  Inadequate recordkeeping.
  System Management and Operation
  •  Failure to meet water supply
demands/interruptions to service (e.g.,
unreliable water source or lack of
auxiliary power).
  •  Lack of approved emergency
response plan.
  •  Inadequate follow-up to
deficiencies noted in previous
assessment/survey.
  Operator Compliance with State
Requirements
  •  Operator is not certified as required
by the State.
  •  Lack of operator training.
  The State must provide the GWS with
written notification, which describes
any significant deficiencies found, no
later than 30 days after the State
identifies the significant deficiency. The
notice may be sent to the PWS, or it may
be provided on-site either at the time
the sanitary survey is conducted or the
significant  deficiency is identified. The
State may specify appropriate follow-up
corrective action steps in the notice or
may notify the GWS of appropriate
corrective actions during the
consultation period. After receiving the
written notification, the GWS has 30
days to consult with the State regarding
corrective actions. However, the State
may prescribe corrective actions and
completion dates, including immediate
and/or interim corrective actions, in lieu
of the consultation process. Under this
rule, a GWS must complete corrective
action or be in compliance with a State-
approved corrective action plan and
schedule within  120 days of receiving
written notice from the State, as
described in Section IV.C of this
preamble. Failure to do so will result in
a treatment technique violation. This
rule requires systems to notify
customers of uncorrected significant
deficiencies. When a significant
deficiency is identified at a PWS that
uses both ground water and surface
water sources, the GWR treatment
technique requirements apply except in
cases where the State determines that
the significant deficiency is in a portion
of the distribution system that is served
by surface water (or ground water under
the direct influence of surface water).
2. What Is EPA's Rationale for the GWR
Sanitary Survey Requirements?
  As discussed in the proposed GWR,
sanitary surveys enable States (and
systems) to provide a comprehensive
and accurate review of the components
of water systems, to assess the operating
conditions and adequacy of the water
system, and to determine if past
recommendations have been
implemented effectively. A GWS has the
responsibility of providing the
information necessary to conduct a
sanitary survey to the State upon
request to enable a comprehensive
assessment of the system.  The purpose
of the sanitary survey is to evaluate and
document the capabilities of the water
system's sources, treatment, storage,
distribution network, operation and
maintenance, and overall management
to ensure the provision of safe water. In
addition, sanitary surveys provide an
opportunity for PWS inspectors to visit
the water system and educate operators
about proper monitoring and sampling
procedures and to provide technical
assistance.
  Historically, sanitary surveys have
been conducted by State drinking water
programs as preventative tools for
identifying water system deficiencies
before contamination occurs. In 1976,
EPA regulations required, as a condition
of primacy, that States develop a
systematic program for conducting
sanitary surveys, but EPA  did not define
the scope of sanitary surveys or specify
minimum criteria at that time. In 1989,
the TCR included a provision requiring
sanitary surveys for systems collecting
fewer than five  TCR samples per month
(systems serving fewer than 4,100
people). For those systems, sanitary
surveys are required under the TCR
once every five  years for CWSs and
NCWSs (but once every 10 years for
NCWSs that use protected or disinfected
ground water). However, the TCR did
not establish what must be evaluated in
a sanitary survey or specifically address
significant deficiencies.
  Consequently, a number of concerns
have been raised regarding post-TCR
sanitary survey  practices. For example,
the GAO investigated sanitary survey
practices in 1993 and found that many
surveys did not evaluate one or more of
the major components and operations
that EPA requires be evaluated under
the final GWR and that efforts to ensure
that deficiencies were corrected were
often limited (USGAO, 1993). A review
of State regulations found that many
States do not specifically require
systems to correct deficiencies. These

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65588   Federal Register/Vol. 71, No.  216/Wednesday, November  8, 2006/Rules  and Regulations
factors, coupled with information on
contaminant occurrence and analysis of
microbial waterborne disease outbreak
data, indicated that public health
protection can be strengthened by
requiring regular sanitary surveys,
specifying the scope of surveys, and
requiring corrective action of significant
deficiencies.
  In 1995, EPA and the States (through
the Association of State Drinking Water
Administrators) issued a joint guidance
on sanitary surveys entitled EPA/State
Joint Guidance on Sanitary Surveys
(USEPA/ASDWA, 1995). Recognizing
the essential role of sanitary surveys and
the need to define the broad areas that
all sanitary surveys should cover, the
guidance recommended eight elements
for a comprehensive sanitary survey.
The guidance also recommended the
development of assessment criteria,
proper documentation of results, and
thorough follow-up, tracking, and
enforcement after the survey. The
IESWTR, (USEPA, 1998b), requires
States to address the same eight
elements in sanitary surveys conducted
at surface water systems and at GWUDI
systems. The GWR incorporates the
same eight elements into the sanitary
survey requirements for GWSs to be
consistent with, and as comprehensive
as, the IESWTR. Based on consultation
with the States and EPA regions,  EPA
believes that the majority of States today
include  the eight elements in their
sanitary survey programs for both
surface water and GWSs.
  In addition to requiring these eight
elements, the GWR requires the State to
conduct sanitary surveys no less
frequently than every tbree years for
CWSs and every five years for NCWSs.
This rule provides the State with the
flexibility to reduce the frequency for
CWSs to every five years for systems
that meet performance criteria (refer to
Section  IV.A.I for criteria). These
frequencies are consistent with the
recommendations for surface water
systems made by the Microbial/
Disinfection Byproducts Federal
Advisory Committee, which included
various  stakeholders representing a
wide range of sectors in the drinking
water community. Given this, EPA
believes that the same three- and five-
year interval for conducting sanitary
surveys  is appropriate for GWSs. The
GWR requires the first sanitary survey
cycle to be completed by December 31,
2012 for CWSs, except those that meet
performance criteria, and December 31,
2014 for all NCWSs and  CWSs that meet
performance criteria. See Section VI of
this preamble for explanation of initial
sanitary survey completion dates.
  As noted earlier, this regulation
attempts to build on existing State
public health programs to the extent
possible. Consequently, the GWR allows
individual elements of a sanitary survey
to be conducted on a phased review
schedule as part of ongoing State
assessment programs within the
established three-or five-year frequency
interval. This allows States to more
efficiently use existing assessment
schedules and maximize the effective
allocation of staff resources and
expertise across a State in conjunction
with other priorities. EPA believes that
the frequency of sanitary surveys and
the required eight sanitary survey
elements in this rule ensure greater
public health protection while
providing  adequate flexibility for States
and systems to effectively implement
the requirements. The GWR requires the
initial sanitary surveys to be completed
six years after rule promulgation for
CWSs and eight years after rule
promulgation for NCWSs. The six to
eight year  time frame for initial sanitary
surveys is based on several
considerations. First, States need time to
adopt the rule and obtain primacy (two
to four years allowed by the SDWA at
1413(a)(l)). In addition, systems are
given three years to comply with
drinking water regulations by the SDWA
at (1412(b)(10)). Finally, States need
three  to five years to complete the first
cycle  of sanitary surveys because there
are many GWSs and States have limited
resources.
  A key finding of the GAO report was
that deficiencies identified in one
sanitary survey were often found still
unconnected at the next sanitary survey.
For example, in a four-State sample of
200 sanitary surveys, GAO found
approximately 60 percent of the surveys
cited  deficiencies that were also cited in
previous surveys. While the report
indicated that  smaller systems (serving
3,300 or fewer people) were in the
greatest need of improvement, GAO
found that, regardless of system size,
previously identified deficiencies
frequently went uncorrected. GAO
found that some States lacked the
authority to ensure that water system
owners and operators correct
documented deficiencies. Additional
causes for uncorrected deficiencies
included a lack of documentation or
ineffective tracking of survey results.
The Agency believes that a  sanitary
survey is an effective tool for identifying
significant deficiencies. Once identified,
it is also essential that such deficiencies
be corrected in a timely manner. A
study of the effectiveness of a range of
best management practices  shows that
follow-up and correction of sanitary
survey deficiencies were correlated with
lower levels of total coliform, fecal
coliform, and E. coli (ASDWA, 1998).
Thus, this rule requires that systems
coordinate with the State within 30 days
of being notified of the significant
deficiency and that the systems correct
the significant deficiency (or be on an
enforceable State-prescribed schedule)
within 120 days of being notified of the
significant deficiency. See Section IV.C
for details on corrective action time
frames.

3. What Were the Key Issues Raised by
Commenters on the Proposed GWR
Sanitary Survey Requirements?
  The majority of commenters on the
GWR proposal were supportive of a
sanitary survey requirement for all
GWSs. Most commenters supported the
proposed frequencies of three years for
CWSs and five years for NCWSs. Several
commenters noted that some States
conduct surveys at more frequent
intervals than  required in this rule.
However, a few commenters suggested
extending the  frequency interval for
CWSs, because they believed that CWSs
would be less  likely to have significant
deficiencies.
  The Agency believes that frequent,
comprehensive sanitary surveys are an'
important proactive public health
measure and that the minimum
frequencies of sanitary surveys under
this rule balance public health
protection with State implementation
issues. This rule requirement is
consistent with the frequency required
for surface water systems under the
IESWTR. The GWR provides flexibility
in allowing States to perform more
frequent sanitary surveys or to reduce
the frequency  for CWSs to five years if
the CWS meets performance criteria
(Section IV.A.I). States also have the
flexibility to phase-in the evaluation of
sanitary survey elements within the
required frequency interval. The Agency
believes that a frequency of three years
for CWSs and  five years"for NCWSs,
combined with flexibility on both
timing and implementation,
appropriately considers limited resource
issues while advancing public health
protection.
  EPA specifically requested comments
on "grandfathering" sanitary surveys
conducted under the TCR to satisfy the
initial  sanitary survey requirements of
the GWR.  The majority of comments
favored allowing the use of sanitary
surveys conducted under the TCR or
existing State programs to meet the
initial  sanitary survey requirements of
the GWR.  These comments were largely
based on an interest in reducing State

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           Federal  Register/Vol.  71,  No. 216/Wednesday,  November 8, 2006/Rules and  Regulations    65589
implementation burden and allowing
States to transition their existing
sanitary survey programs into programs
and schedules that meet the
requirements of the GWR.
  Because of the time frames laid out in
the GWR for initial and repeat sanitary
surveys, grandfathering sanitary surveys
is not practicable. States must complete
their initial CWS sanitary surveys six
years after rule promulgation for CWSs
and eight years for NCWSs. The
deadline for completing the first round
of sanitary surveys is longer than the
minimum required sanitary survey
frequency, so grandfathering would not
result in a burden reduction for the
State. For example, if a State were to
grandfather a CWS sanitary survey from
2005, they would be required to
complete a second sanitary survey by
2008 and a third by 2011, whereas a
State that completed their first sanitary
survey in  2009 would not be required to
complete their second sanitary survey
until 2012. As described in Section
IV.A.2, the six to eight year time frame
for initial sanitary surveys is based on
several considerations. First, States need
time to adopt the rule and obtain
primacy (two to four years allowed
under the SDWA at  1413(a)(l)). In
addition, systems are given three years
to comply with drinking water
regulations by the SDWA at
(1412(b)(10)). Finally, States need three
to five years to complete the first cycle
of sanitary surveys because there are
many GWSs and States have limited
resources.
  EPA believes that it is important to
reduce State implementation burden
and that information from existing
sanitary surveys and other sources is an
important resource.  Thus, this rule
allows States to reduce the frequency of
sanitary surveys for CWSs that meet
performance criteria (Section IV.A.I) at
any time subsequent to the effective
date of this rule from every three to
every five years. This allows States to
reduce the implementation burden of
sanitary surveys based on information
collected under the TCR and existing
sanitary survey programs while still
ensuring a minimum sanitary survey
frequency of five years for both CWSs
and NCWSs. Since a significant
proportion of GWSs are small NCWSs
and the  GAO report found the greatest
need for improvement in smaller
systems, EPA believes that a reduction
in frequency for NCWSs would not
advance public health protection. EPA
notes that surveys or elements of
sanitary surveys conducted under the
TCR or as part of site assessment  or
other State programs may be used to
meet the GWR requirements if they meet
the criteria specified in the GWR (i.e., if
the minimum eight elements specified
in the GWR are addressed at the
specified GWR frequency).
  EPA received a number of comments
on the 30-day time frame that States
have to notify a system when a
significant deficiency is identified in the
sanitary survey. Some commenters
noted that this requirement is consistent
with current procedures; notice of
significant deficiencies is often
provided to a system much sooner.
However, other commenters were
concerned that this requirement placed
an unnecessary deadline on the State
and that current State policies and
practices adequately address timely
notification of systems with significant
deficiencies.
  The Agency believes that timely
notification of significant deficiencies is
essential to the timely correction of
those deficiencies and to the safety of
drinking water. EPA believes requiring
a 30-day  maximum notification period
in all States is reasonable, given the
potential public health risk of
significant deficiencies, and ensures
equitable protection of public health
across the nation.
  EPA also received comments on what
constitutes a significant deficiency
under the GWR. EPA proposed defining
significant deficiencies as a defect in
design, operation, or maintenance,  or a
failure or malfunction of the sources,
treatment, storage, or distribution
system that the State determines to be
causing, or has the potential for causing,
the introduction of contamination into
the water delivered to consumers.
Several commenters urged EPA to go
beyond that definition and require
States to specify a minimum list of
significant deficiencies under each  of
the applicable eight sanitary survey
components set out in the EPA/State
Joint Guidance on Sanitary Surveys.
EPA also received comments regarding
specific examples of significant
deficiencies in each applicable
component. Section IV.A.I of this
preamble includes specific examples  of
some significant deficiencies provided
by commenters.
  The Agency believes that to provide
adequate public health protection,
States must identify and require
correction of all significant deficiencies.
Also, EPA recognizes the importance for
the State  to include additional case-
specific deficiencies. This rule states
that significant deficiencies "include,
but are not limited to, defects in design,
operation, or maintenance, or a failure
or malfunction of the sources, treatment,
storage, or distribution system that  the
State determines to be causing, or has
the potential for causing, the
introduction of contamination into the
water delivered to consumers." The
GWR requires each State, in its primacy
application, to define and describe at
least one specific significant deficiency
in each of the eight sanitary survey
elements. This enables States to work
within their existing programs to define
significant deficiencies as part of their
primacy application  and to define and
describe significant deficiencies that
may be unique to system size, type,
location, or State requirements. EPA
also recognizes that some systems may
not have all eight components; for
example, some TNCWSs may not have
storage or require certified operators.
  EPA requested comment  on having
public involvement and/or  meetings for
certain  PWSs to discuss the results of
sanitary surveys and specifically what
approaches might be practical and not
overly burdensome to involve the public
in working with water systems to
address the results of sanitary surveys.
Some commenters suggested publishing
the results in the system's Consumer
Confidence Report (CCR) or reviewing
the results at a public meeting. Others
supported notifying the public that the
results were available and how those
results could be obtained. Some
commenters noted that significant
deficiencies would be corrected rapidly
and that involving or informing the
public after the correction might not be
useful. One commenter suggested
posting the results of surveys in a public
place for non-community systems.
  EPA believes that adequate
opportunities exist for customers to
obtain information on the complete
sanitary survey of their water supplier.
Results of sanitary surveys and
notification from the  State to the water
supplier of significant deficiencies
would be available to the public upon
request from the State or the water
supplier. However, EPA also believes
that the public served by the water
system should be made aware of
significant deficiencies found in
sanitary surveys that  remain
uncorrected and be fully informed as to
how and when those deficiencies will
be corrected.  This rule requires systems
to notify customers of such  significant
deficiencies including the date and
nature of the  significant deficiency, the
schedule for correction,  any interim
measures taken, and the progress to
date. The State may require the system
to notify customers of corrected
significant deficiencies. This
requirement is described further in
Section IV.D of this preamble.
  EPA received comments suggesting
that the sanitary survey provisions of

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65590   Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations
the TCR are sufficient to address viral
and bacterial pathogens in GWSs and
there is no need for sanitary surveys
under the GWR. While EPA believes the
TCR was a significant step forward for
public health protection in 1989, the
TCR does not require systems to correct
significant deficiencies or require a
minimum frequency of sanitary surveys
for all systems. Thus, the GWR sanitary
survey requirement better addresses the
potential public health consequences of
uncorrected significant deficiencies.

B. Source Water Monitoring

  This rule requires ground water
source monitoring as an essential
element in its risk-targeted approach for
identifying those GWSs with source
water fecal  contamination that need
corrective action.  Systems targeted for
source water monitoring are those with
an indication that they may be at risk for
fecal contamination. Indicators of risk
may come from total coliform
monitoring, hydrogeologic sensitivity
analyses, or other system-specific data
and information. This rule requires
triggered source water monitoring and
provides States with the option to
require assessment source water
monitoring. Source water monitoring is
not required for any GWS that is already
providing at least 4-log treatment of
viruses.
  A GWS with a distribution system
TCR sample that tests positive for total
coliform is  required to conduct triggered
source water monitoring to evaluate
whether the total coliform presence in
the distribution system is due to fecal
contamination in the ground water
source. Triggered source water
monitoring provides a critical ongoing
evaluation of GWSs.
  As a complement to the triggered
source water monitoring provision, the
GWR gives  States the flexibility to
require more comprehensive assessment
source water monitoring on a case-by-
case basis. The purpose of this optional
assessment source water monitoring
requirement is to target source water
monitoring to systems that the State
determines are at higher risk for fecal
contamination. States are in the best
position to assess which systems are at
risk and would most benefit from source
water monitoring.
  EPA believes that source water
monitoring targeted at higher risk
systems, namely triggered source water
monitoring, in conjunction with
optional assessment source water
monitoring, will be  effective in
identifying systems with source water
fecal contamination. With
implementation  of the follow-up
corrective action requirements outlined
in Section IV.C, these requirements will
provide meaningful opportunities to
reduce public health risk for a
substantial number  of people served by
GWSs.
BILLING CODE 6560-50-P

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           Federal Register/Vol. 71, No.  216/Wednesday, November  8,  2006/Rules  and Regulations    65591

                Figure IV-2:  Triggered Source Water Monitoring Requirements
                                                GWS conducts routine TCR
                                                        monitoring
                                                      Total Conform
                                                    Positive Sample?1
                                                      GWS provides
                                                     4-log inactivation
                                                       of viruses?
            Compliance Monitoring
               GotolV.C.Lb
                                Within 24 hours, GWS collects one sample from each GW source
                                Within 24 hours,
                        GWS collects 5 repeat samples at
                         each source that tested positive
                                                                                   No
State requires immediate
   Corrective Action
 Go to Section IV.C.1
                                                      One or more
                                                     fecal indicator
                                                       Positive?
                                                                                  No
                                                               Yes
                                                    Corrective Action
                                                       Required
                                                  Go to Section IV.C.1
                1 Answer "no" if the sample is invalidated under 141.21(c) or the State determines that the cause of
                the total coliform-positive sample directly relates to the distribution system
                2lf approved by the State, systems with more than one ground water source may monitor at
                representative ground water source(s) according to a triggered source water monitoring plan
                3£. co//, enterococci, or coliphage
BILLING CODE 6560-50-C

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65592   Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations
1. What Are the Requirements of This
Rule?
  a. Triggered source water monitoring.
A GWS must conduct triggered source
water monitoring within 24 hours of
receiving notification that a routine
sample collected in accordance with
§ 141.21(a) (TCR) is total coliform-
positive. A GWS must collect at least
one ground water source sample from
each ground water source (e.g., a well or
spring) in use at the time the total
coliform-positive sample was collected.
Triggered  source water monitoring is
required unless: (1) The system provides
at least 4-log treatment of viruses (using
inactivation, removal, or a State-
approved  combination of 4-log virus
inactivation and  removal) before or at
the first customer for each ground water
source; (2) the system is notified that a
positive sample collected in accordance
with § 141.21(a) (TCR) has been
invalidated under § 141.21(c); or (3) the
cause of the total coliform-positive
collected under §141.21(a) directly
relates to the distribution system as
determined by the  system according to
State criteria or as determined by the
State. The State may extend the 24-hour
limit on a case-by-case basis if the State
determines that 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.
  Systems are not required to conduct
triggered source water monitoring if,
according to State criteria or a State
determination, the cause of the total
coliform-positive sample collected
under § 141.21(a) directly relates to the
distribution system. If the GWS makes
the decision according to State criteria,
the GWS must document the decision in
writing; if the decision is made by the
State, the State must document the
decision in writing. In the primacy
application, the State must include
criteria that will be used to determine
that the cause of a total coliform-
positive sample collected under
§ 141.21(a) is directly related to the
distribution system.
  If the State approves the use of E. coli
as a fecal indicator for triggered source
water monitoring, GWSs serving 1,000
people or  fewer may use a TCR repeat
sample collected from a ground water
source to simultaneously meet the
requirements of § 141.21(b) and satisfy
the GWR's triggered source water
monitoring requirements for that ground
water source only.
  If approved by the State, systems with
more  than one ground water source may
conduct triggered source water
monitoring at a representative ground
water source or sources. The State may
require systems with more than one
ground water source to submit for
approval a triggered source water
monitoring plan that the system will use
for representative sampling. A triggered
source water monitoring plan must
identify ground water sources that are
representative of each monitoring site in
the system's TCR sample siting plan.
  If any initial triggered source water
sample is fecal indicator-positive, the
system must collect five additional
source water samples within 24 hours at
that site, unless the State requires
immediate corrective action to address
contamination at that site. The samples
must be tested for the same fecal
indicator for which the initial source
water sample tested positive.
  Ground water systems that purchase
or sell finished drinking water (referred
to as consecutive or wholesale systems,
respectively) must comply with
triggered source water monitoring
provisions for their own sources.
  Consecutive and wholesale systems
must also comply with  other triggered
source water monitoring requirements.
A consecutive GWS that has a total
coliform-positive sample collected
under § 141.21(a) (TCR) must notify the
wholesale system(s) within 24 hours of
being notified of the total coliform-
positive sample. If a wholesale GWS
receives notice from a consecutive
system it serves that a sample collected
under § 141.21(a) (TCR) is total
coliform-positive, the wholesale GWS
must conduct triggered source water
monitoring. If the sample is fecal
indicator-positive, in addition to
notifying its own customers, the
wholesale GWS must notify all
consecutive systems served by that
ground water source. The consecutive
system is responsible for providing any
required public notice to the persons it
serves.
  b. Assessment  source water
monitoring. The GWR provides States
with the option to require systems to
conduct assessment source water
monitoring at any time and require
systems to take corrective action. See
Section IV.B.2.b for EPA's
recommendations of when assessment
source water monitoring may be
appropriate and how to structure the
monitoring program. If the State chooses
to use HSAs to determine the
appropriateness of assessment source
water monitoring, then systems must
comply with State requests for
information.
  c. Source water microbial indicators
and analytical methods. A system that
collects a source water sample to
comply with this rule must analyze the
sample for one of the three fecal
indicators (E. coli, enterococci, or
coliphage). Under this rule, GWSs must
use one of seven specified analytical
methods for E. coli, one of three
methods specified for enterococci, or
one of two methods specified for
coliphage. The system is required to test
at least a 100 mL sample volume for one
of the three fecal indicators (E. coli,
enterococci, or coliphage). All analyses
must be conducted by a laboratory
certified by the State  or EPA.
  d. Invalidation of a fecal indicator-
positive ground water source sample.
This rule allows  systems to obtain
written State invalidation of a fecal
indicator-positive ground water source
sample under either of the following
conditions: (1) The system provides the
State with written notice from the
laboratory that improper sample
analysis occurred; or (2) the State
determines and documents in writing
that there is substantial evidence that a
fecal indicator-positive ground water
source sample is due to a circumstance
that does not reflect source water
quality. If the State invalidates a fecal
indicator-positive ground water source
sample, the system must collect another
ground water source  sample within 24
hours of being notified of the
invalidation by the State and have it
analyzed for the  same fecal indicator.
The State may extend the 24-hour limit
on a case-by-case basis if it determines
that the system cannot collect the
ground water source  water sample
within 24 hours  due to circumstances
beyond the system's control. In the case
of an extension, the State must specify
how much time the system has to
collect the sample.
2. What Is EPA's Rationale for the GWR
Source Water Monitoring Requirements?
  a. Triggered source water monitoring.
  i. Overall basis for  provision. The
GWR builds on the public health
protection provided by the TCR by
requiring systems to collect a ground
water source sample  when a TCR
distribution system sample is total
coliform-positive. Because a total
coliform-positive sample in the
distribution system may be caused by
either a distribution system problem or
source water contamination, the GWR
triggered source  water monitoring
provision is necessary to distinguish
between these two possible sources of
fecal contamination.  Thus, using the
total coliform indicator is an efficient
way to target higher risk systems where
source water monitoring is warranted to
investigate potential  fecal

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          Federal Register/Vol.  71, No. 216/Wednesday, November  8,  2006/Rules and Regulations    65593
contamination. EPA believes that the
GWR triggered source water monitoring
provisions provide an effective means
for improving public health protection.
  Total coliform monitoring in the
distribution system is already required
under the TCR. Thus, total coliform
monitoring provides a no-cost screening
for potential fecal contamination and
pathogen occurrence at the source. Total
coliform is a sensitive indicator for the
presence of potential fecal
contamination. In the occurrence
studies evaluated for the GWR, wells
that were monitored with high
frequency for enterovirus and total
coliforms detected both enterovirus and
total coliform in their source water (i.e.,
Lieberman et al., 2002; Karim et al.,
2004; Wisconsin Department of Health,
2000). Total coliform presence in  source
water can also be an indicator of recent
surface and near surface water inflow to
ground water, and pathogens originate
at or near the surface.
  Triggered source water monitoring
provides an ongoing evaluation of fecal
contamination in the source water of all
GWSs. Because well conditions and
sources of fecal contamination can
change over time, EPA believes that the
ongoing continuous assessment
provided by triggered source water
monitoring is important.
  EPA believes that the triggered source
water monitoring requirements of the
GWR will effectively target higher risk
GWSs. EPA's analysis indicates that the
triggered source water monitoring
provisions will identify nearly 40
percent of those wells with fecal
contamination in their source water (See
Chapter 6 of USEPA,  2006d). In
addition, the wells with the highest
frequencies of fecal contamination
occurrence (which EPA believes are the
highest risk wells from a public health
perspective) will likely be captured first
and wells with less frequent fecal
contamination will be identified over
time (USEPA, 2006d).
  ii. Reduced burden for small systems.
Under the final GWR, a GWS serving
1,000 people or fewer may use a TCR
repeat sample to simultaneously meet
requirements of the TCR and the GWR.
Under the TCR, when a total coliform
sample at a small system (serving 1,000
people or fewer)  is positive, the TCR
requires the system to collect four repeat
samples (one upstream and proximate to
the initial total coliform-positive, one at
the same location, one downstream and
proximate to the original total coliform-
positive,  and one at another unspecified
location). If the State approves the use
of E. coli as a fecal  indicator for ground
water source monitoring, the GWR
allows these small  systems to meet the
repeat monitoring requirements of
§ 141.21(b) (TCR) by collecting their
unspecified fourth  repeat sample at the
ground water source, thereby satisfying
the GWR's triggered source water
monitoring requirements for that ground
water source at the same time. The
purpose of this provision is to mitigate
the triggered fecal indicator source
water monitoring burden for small
systems and to improve upon the
diagnostic value  of repeat sampling
under the TCR.
  The TCR repeat sample can be used
for satisfying both the TCR repeat
sample requirement and the initial
source water fecal indicator under the
GWR because the TCR methods and
requirements provide the information
necessary for complying with the GWR.
If the repeat sample is negative for total
coliform bacteria, then it is also negative
for E. coli bacteria, and no further
testing under the GWR is required.
Under the TCR, if a repeat sample is
positive for total  coliform bacteria, the
sample must then be further analyzed
for the presence of either E. coli or fecal
coliforms. If the sample is analyzed for
E. coli, that will satisfy the GWR
triggered  monitoring requirements.
  Total coliform  bacteria are a group of
bacteria that include E. coli. The
methods approved for the analysis of
the water samples taken under the TCR
can be found at § 141.21. Most of these
methods are also approved for E. coli
monitoring under the GWR (see Table
IV-1 and § 141.402(c)). The analytical
methods approved for use under the
TCR listed in Table IV-1 may all be
used for both total coliform detection,
and most can be used for subsequent E.
coli detection under the GWR. Two of
the methods approved under the TCR
(and listed with an asterix in Table IV-
1) can be used  for total coliform
detection only. In these two techniques
(one of which is multiple tube
fermentation and the other of which is
membrane filtration using m-Endo
medium), total coliforms are first
cultured and confirmed. The laboratory
analyst could then proceed to further
analyze the total coliform-positive
culture for either fecal coliforms or E.
coli by simply  choosing which
subsequent medium to inoculate.
Testing for fecal coliforms requires EC-
Broth while testing for E. coli requires
use of EC-MUG broth. These two broths
are similar, and require the same
incubation temperatures and conditions.
The only difference between the two
media is the addition of the substrate 4-
methylumbelliferone-(3-D-glucuronide
(MUG) to EC Broth, which is added to
detect E. coli. Thus, if the State has
approved E. coli as the fecal indicator
for the GWR, the E. coli sample
analyzed under the TCR will meet the
GWR source water sample requirements.
For the TCR repeat sample, a PWS must
collect a 100 mL water sample and
analyze it  for total coliform bacteria, and
further analyze it for a fecal indicator if
it is total coliform-positive. This means
that small systems (serving 1,000 people
or fewer) have  no additional sampling
burden or costs from the GWR triggered
source water monitoring requirement for
an initial source water sample.
 TABLE IV-1 .—METHODS APPROVED FOR DETECTION OF TOTAL COLIFORMS UNDER THE TCR AND FOR THE DETECTION
             OF E. coli UNDER THE GWR (SEE §141.402(C) FOR DETAILS REGARDING THESE METHODS)**
Method technology type
Multiple tube fermentation 	


Enzyme Substrate 	 	


Membrane filtration 	 	


Method
(LTB/P-A -H> BGLB)* 	
EC-MUG
NA-MUG 	 	
Colilert/Colilert-1 8 	
Colisure
E* Colite Test 	
(m-Endo->LTB/BGLB)* 	
EC-MUG
Ml Aaar 	
Total
coliforms
detected
X


X
X
X
X

X
E. coli
detected

X
X
X
x
X

x
X
TCR/GWR
approval
X
X
X
x
x
x
x
x
X

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65594    Federal Register/Vol. '71, No. 216/Wednesday, November  8,  2006/Rules  and Regulations

 TABLE IV-1.—METHODS APPROVED FOR DETECTION OF TOTAL COLIFORMS UNDER THE TCR AND FOR THE DETECTION
       OF E. co//UNDER THE  GWR (SEE §141.402(C) FOR DETAILS REGARDING THESE METHODS)**—Continued
Method technology type

Method
m-ColiBlue 24 Test 	
Total
coliforms
detected
X
E. coli
detected
X
TCR/GWR
approval
X
  * Methods in parentheses detect total coliforms but not E. coli; if a total coliform sample is determined by this method in the source water sam-
ple, the analyst can choose the appropriate inoculation medium to analyze for E. coli.
  ** If a total coliform sample is determined negative, no further testing under the GWR is required. If it is positive, the analyst can choose the
appropriate E. coli method.
  iii. Provision for total coliform-
positive result directly related to the
distribution system. EPA recognizes that
some systems may have a known
problem in their distribution system
that causes total coliform-positive
results. In cases when the cause of a
total coliform-positive result collected
under § 141.21(a) is directly related to
the distribution system according to
State criteria or a State determination,
systems are not required to collect
ground water source samples to
investigate potential fecal
contamination in the source water. A
State must include in its primacy
application the criteria it will use to
determine whether the cause of a total
coliform-positive sample collected
under § 141.21(a) is directly related to
the distribution system. Systems will
use these criteria to determine if the
cause of a total coliform-positive sample
is directly related to the distribution
system. If the sample meets the criteria,
the system is not required to do
triggered source water monitoring. The
State needs to  determine these criteria
as part of their primacy package so that
GWSs that collect a total coliform-
positive sample can decide whether
they need to collect a source water
sample(s) within the required 24 hour
timeframe. The system must document
this determination to the State within 30
days so the State can ensure that the
criteria are used correctly and that no
potential public health risk from source
water contamination has been
overlooked. For issues not covered by
the pre-determined criteria, the State
can also make a determination that the
cause of the total coliform-positive
sample directly relates to the
distribution system.
  iv. Basis for  additional fecal indicator
sampling following triggered source
water monitoring. Numerous public
comments on the proposal expressed
concern that a corrective action should
not be required based on one source
water indicator-positive  sample, as EPA
proposed for triggered source water
monitoring. The rationale for the
proposal was that the likelihood of a
false positive result occurring in both
the distribution system sample and the
fecal indicator source water sample
would be small, and therefore it would
be likely that the source water positive
result was caused by true
contamination.
  EPA has re-evaluated the use of repeat
samples under the triggered source
water monitoring provisions. Given that
total coliform-positives in the
distribution system can result from
either distribution system or source
water causes, a total coliform-positive in
the distribution system does not
necessarily predict fecal contamination
of the source water. The possibility of
false positives at the source and the
associated potential for unnecessary
follow-up corrective actions, even if
relatively infrequent, prompted EPA to
revise the final rule triggered source
water monitoring provisions to require
five additional samples following the
initial positive sample before requiring
corrective action (if one or more
additional sample is positive), unless
the State determines that immediate
corrective action is necessary. In
addition, the potential cost implications
for a corrective action could be
substantial, especially for small systems.
  EPA believes that in most cases these
five additional samples should capture
the fecal contamination event since the
samples are taken within 24 hours.
Discrete contamination releases, such as
fecal septage, together with discrete
precipitation events, become dispersed
by hydrogeological processes over time.
As a result, shorter duration events at
the original contamination source may
become longer duration (i.e., days or
weeks) but more diluted events at the
well. Thus, if an initial fecal indicator-
positive is detected at the well, that
occurrence should be detectable again
with additional samples within 24
hours. Nevertheless, since the nature
and source of contamination and the
subsurface condition vary from site to
site, prompt resampling within 24 hours
is needed to capture events that may not
be dispersed over time. Prompt
resampling is particularly important in
cases where the initial sampling event
transpires at the tail-end of the well
contamination event.
  b. Assessment source water
monitoring. As a complement to the
triggered source water monitoring
provision, States have the option of
requiring systems to conduct assessment
source water monitoring. This flexible
provision gives States the opportunity to
target higher risk systems for additional
source water monitoring and require
corrective action, if necessary. EPA
decided not to include requirements for
assessment source water monitoring in
the GWR for the reasons given in
Section II.C of the preamble. Rather,
EPA decided to give States flexibility to
require assessment source water
monitoring on a case-by-case basis. The
purpose for this optional source water
monitoring provision is to target
systems that the States believe are at
high risk from fecal contamination for a
thorough evaluation of source water
quality. Also, this allows lower  risk
GWSs to avoid unnecessary sampling
(as determined by States).
  While EPA believes that triggered
source water monitoring will capture
many high risk systems, EPA also
recognizes that tbe triggered source
water monitoring provisions have
limitations. Triggered source water
monitoring under the TCR may  not be
timely (soon enough) or frequent
enough to identify systems with
intermittent fecal contamination. Also,
coliforms are not a good indicator in
certain aquifers in which viruses travel
faster and further than bacteria.  EPA
believes that assessment source water
monitoring can be an important
complement to triggered source water
monitoring because assessment  source
water monitoring provides a thorough
examination of the source water at those
systems that States deem to be at
potentially high risk from fecal
contamination. The flexibility of this
requirement allows States to require
assessment source water monitoring
when and where it is needed most.
Source water quality can change over
time, so it is important for States to be

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           Federal  Register/Vol.  71,  No. 216/Wednesday,  November 8, 2006/Rules and Regulations    65595
able to use assessment source water
monitoring at any point in time. State
programs work closely with PWSs on a
daily basis and are thus knowledgeable
about system specific conditions and
issues. Therefore, EPA believes that the
States are in the best position to assess
for which systems the thorough
evaluation  of source water quality
provided by assessment source water
monitoring is most appropriate. EPA
believes that assessment source water
monitoring programs within the States'
discretion will be important to identify
fecally contaminated systems for which
corrective action is necessary to protect
public health. EPA expects that States
may use assessment source water
monitoring for high-risk systems that are
potentially susceptible to fecal
contamination, especially where
contamination is often present but
intermittent enough to be missed by
triggered source water monitoring.
  i. EPA's recommendations for
targeting systems for assessment source
water monitoring. Information on a
system's potential susceptibility to fecal
contamination is available to the States
from many sources. For example, HSAs,
source water assessments, wellhead
protection  plans, past microbial
monitoring data particularly triggered
source water monitoring results and
frequency,  and sanitary survey findings
are available to States. In addition to
these sources of information, EPA
recommends that States consider the
following risk factors in targeting
susceptible systems for assessment
source water monitoring: (1) High
population density combined with on-
site wastewater treatment systems,
particularly those in aquifers with
restricted geographic extent, such as
barrier island sand aquifers; (2) aquifers
in which viruses may travel faster and
further than bacteria (e.g. alluvial or
coastal plain sand aquifers); (3) shallow
unconfined aquifers; (4) aquifers with
thin  or absent soil cover; (5) wells
previously  identified as  having been
fecally contaminated; and (6) sensitive
aquifers. These factors are described in
more detail below.
  Some localities may be at high risk
because they serve large, sometimes
seasonal, populations in areas without
centralized sewage treatment and their
aquifers are of restricted geographic
extent, such as barrier island sand
aquifers and Great Lakes island karst
limestone aquifers. In these locations,
the large population using septic tanks
can overload the subsurface attenuation
capability. Outbreaks have occurred in
such resort communities (e.g., South
Bass Island, OH, Ohio EPA, 2005, CDC,
2005; Drummond Island, MI, Ground
Water Education in Michigan, 1992;
Chippewa County Health Department,
unpublished report, 1992) due to
overloaded septic tanks.
  Viruses travel faster and further than
bacteria in some aquifers. In barrier
island sand aquifers, traditional
bacterial fecal indicator organisms such
as total coliform and E. coli may not be
mobile or sufficiently long-lived in the
subsurface so as to adequately indicate
the hazard from longer-lived and more
mobile viral pathogens. Thus, a system
could have fecal contamination and yet
not be triggered for source water
monitoring by TCR monitoring results.
In such cases,  assessment source water
monitoring using coliphage would be
the best means for identifying fecal
contaminants because coliphage is a
viral fecal indicator and thus is more
likely to reach the well than bacterial
indicators such as E. coli and
enterococci.
  Shallow, unconfined aquifers are high
risk because the vertical flow path to tbe
aquifer is short and  unrestricted by
barriers. Pathogens originate at or near
the surface and may be more likely to
contaminate well water when the travel
time for infiltrating  precipitation is
short and unhindered.
  Wells previously identified as having
been fecally contaminated should be
considered high risk because such fecal
contamination can reoccur. For
example, wells in this category may
include wells associated with a previous
acute TCR violation related to the
source or those wells that had an initial
fecal indicator-positive triggered source
water sample but had five negative
additional samples (especially wells
with highly variable source water such
as those in sensitive aquifers). Wells
with highly variable source water may
be subject to occasional short-lived
contamination events. Thus it is
possible to have a true fecal indicator-
positive sample followed by true fecal
indicator-negative samples. Exposures
during intermittent contamination
events can be significant, so it is
important to identify such high-risk
systems. This is best accomplished
through a thorough source water
evaluation program  such as assessment
source water monitoring.
  Sensitive aquifers (e.g., karst,
fractured bedrock, or gravel) can have
fast (kilometers per day) and direct
ground water flow through large
interconnected openings (void spaces)
during which very little pathogen
attenuation may occur (either by natural
inactivation or attachment) between a
fecal source of contamination and the
well. Consequently, sensitive aquifers
are efficient at transmitting pathogens, if
present, from surface and near-surface
sources to PWS wells. Ground water
flow in non-sensitive aquifers (such as
a sand aquifer) tends to be very slow
(feet per day), takes a very indirect path
around a very large number of sand
grains, and provides more opportunities
for pathogen die-off and attachment.
The faster flow travel time within a
sensitive, as opposed to a non-sensitive,
aquifer enables a much larger
contaminant plume from potential fecal
contamination events (e.g., failing septic
systems or a leaking sewer line).
  When ground water flow is fast and
direct as in sensitive aquifers,
contamination can be short and
intermittent and difficult to capture.
The frequency by which triggered
source water monitoring is  prompted
via detection of a total coliform-positive
sample under the TCR may not be
timely enough to recognize that a well
is at risk from fecal contamination. First,
TCR monitoring at some systems is
infrequent. Small systems conduct
limited total coliform monitoring in the
distribution system under the TCR and
thus intermittent fecal contamination of
the source could be missed (i.e., these
systems may conduct triggered source
water monitoring infrequently under the
GWR). Second, the lag time between an
initial fecal contamination event  and
total coliform presence in the
distribution system may be several days.
Thus, if the fecal contamination event is
of short duration, triggered  source water
monitoring may not capture the initial
event.
  Some of the largest reported
waterborne disease outbreaks in GWSs
have occurred among systems drawing
water from sensitive aquifers. Table IV—
2 provides a summary of recent
outbreaks reported in sensitive aquifers.
The number and nature of recent
waterborne outbreaks shown in the table
suggest that additional measures  are
necessary to protect those consuming
water from PWS wells in sensitive
aquifers. Noteworthy among these
outbreaks is the South Bass Island, Ohio
outbreak. After that outbreak in 2004, 16
of the 18 TNCWSs on South Bass Island
tested positive for fecal indicator
organisms (Ohio EPA, 2005; CDC, 2005).
Thus, the monitoring protections offered
by the TCR were inadequate to protect
the community from experiencing a
waterborne disease outbreak in this
karst limestone aquifer.

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65596   Federal Register/Vol.  71, No. 216/Wednesday, November  8,  2006/Rules and Regulations

  TABLE IV-2.—RECENT WATERBORNE DISEASE OUTBREAKS (PWSs) REPORTED IN KARST LIMESTONE AND FRACTURED
                                          BEDROCK (SENSITIVE) AQUIFERS
                Location
                                                      Reference
                                               Number of illnesses/agent
                                         Outbreaks in Karst Limestone Aquifers
South Bass Island, OH 	
Walkerton, Ontario, Canada
Brushy Creek, TX 	

Reading, PA 	

Racine, MO  	

Drummond Island, Ml


Cabool, MO  	
 Ohio EPA, 2005; CDC, 2005 	
 Health Canada, 2000; Bopp era/., 2003; Wor-
   thington et al., 2002.
 Bergmire-Sweat et al., 1999; Lee et al., 2001

 Moore et al., 1993	
 MO Department of Health, unpublished report,
   1992.
 Ground Water Education in Michigan,  1992;
   Chippewa County Health Department,  un-
   published report, 1992.
 Swerdlow era/., 1992 	
1,450/Norovirus, Campylobacter, Salmonella.
1,346   cases/E.    coli    O157:H7    (+
  Campylobacter); 7 deaths.
1,300-1,500 cases/Cryptosporidium (not rec-
  ognized as GWUDI until after the outbreak).
551  cases/'Cryptosporidium (not recognized
  as GWUDI until after the outbreak).
28 cases/HAV.

39 cases/Unknown.
243 cases/E. coli O157:H7; 4 deaths.
                                        Outbreaks in Fractured Bedrock Aquifers
Big Horn Lodge WY
Atlantic City WY
Couer d'Alene ID
Island Park ID
Northern AZ

Anderson et al 2003
Parshionikar et al 2003
Rice ef al 1 999
CDC, 1996 	
Lawson et al 1991 	

35/Norovirus
84/Norovirus
1 1 7/Arcobacter butzleri
82 cases/Shigella
900 cases/Norwalk virus

  Where the type of aquifer is unknown,
EPA recommends that the State conduct
an HSA to identify sensitive aquifers
and to determine if assessment source
water monitoring is appropriate. In
sensitive aquifers, more frequent
monitoring could more quickly identify
wells  with fecal contamination. EPA
recommends that States use HSAs as a
tool to determine at-risk GWSs, and EPA
intends  to provide guidance on how to
conduct HSAs.
  Several means can be used to evaluate
wells  without site-specific inspections
to determine if they are located in
sensitive hydrogeologic settings. For
example, hydrogeologic data are
available from published and
unpublished materials such as maps,
reports,  and well logs. As discussed in
more  detail in the GWR proposal
(USEPA, 2000a), the United States
Geologic Survey (USGS), U.S.
Department of Agriculture's Natural
Resource Conservation Service, USGS
Earth  Resources Observation System
Data Center, the EPA Source  Water
Assessment Program and Wellhead
Protection Program, State geological
surveys, and universities have
substantial amounts of regional site-
specific information.  States can also
base assessments on available
information about the character of the
regional geology, regional maps, and
rock outcrop studies.
  In summary, HSAs can be an effective
screening tool for identifying GWSs
susceptible to fecal contamination for
which assessment source water
monitoring would be appropriate and
beneficial.
  ii. EPA's recommendations for
assessment source water monitoring
program. EPA recommends that States
require systems that are conducting
assessment source water monitoring to
collect a total of 12 ground water source
samples that represent each month the
system provides ground water to the
public. The 12 sample minimum is
based on several considerations:
  • The sampling frequency should
consider diminishing returns on the
effectiveness of identifying fecally
contaminated wells;
  • The sampling should be frequent
enough to capture a range of conditions
that can vary over the course of a year;
and
  • The sampling frequency should
consider ground water source
monitoring costs incurred by GWSs.
  EPA estimates that about 26 percent
of all wells have E. coli occurrence at
some time, but the periods of such
contamination may be very short and
thus difficult to detect by the triggered
source water monitoring requirements
for some systems.  With 12 assessment
ground water source samples alone (i.e.,
absent any triggered source water
monitoring), at least half of the wells
with sometime E. coli contamination
would be expected to test positive at
least once. Table IV-3  shows that as
sampling frequency increases above 12
samples, the ability to identify
additional wells that have E. coli
presence rises more slowly and that
relatively smaller percentages of
additional wells with E. coli are
identified per additional sample assay.
This table shows that the sampling with
12 assays (j'.e., tests) captures 52 percent
of the wells with sometime E. coli
contamination, but sampling with 24
assays only captures an additional nine
percent.

 TABLE  IV-3.—NUMBER OF E. coli AS-
  SAYS  AND PERCENT CONTAMINATED
  WELLS  IDENTIFIED
Number of assays
(N)
3 	
6 	
12 	
24 	
36
48 	
60

Fraction
identified
(Mean in
percent)
28
40
52
61
65
68
70

  The wells that the assessment source
water monitoring identifies as
contaminated tend to be those that have
frequent occurrence of E. coli. Those
wells with highly infrequent E. coli
occurrence would be difficult to capture
even with a significant increase in
number of samples because the overall
period of time of indicator occurrence is
small relative to when the sampling
occurs.
  Considering the costs of additional
assays  (beyond 12 assessment ground
water source samples) and the reduced
efficiency at identifying additional

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           Federal Register/Vol. 71, No. 216/Wednesday, November 8,  2006/Rules  and Regulations    65597
contaminated wells, EPA believes that
12 assays are appropriate.
  EPA recommends that the assessment
source water monitoring program be
representative of the system's typical
operation. Using a minimum of 12
samples for assessment source water
monitoring would also ensure sampling
for each month that most systems are in
operation, which is important because
of the impact that seasonal events can
have on contamination (e.g., heavy rain
events). For seasonal systems, EPA
recommends equally distributing 12
samples or sampling during consecutive
years.
  The option under the GWR for States
to specify assessment source water
monitoring requirements allows States
to initiate a more thorough source water
monitoring program than that resulting
from the triggered source water
monitoring provisions alone on a case-
by-case basis, as deemed appropriate.
For example, a sanitary survey may
indicate that there has been a recent
development of added source water
vulnerability that would warrant
additional source water sampling to
discern whether there is potential fecal
contamination beyond that which
would be triggered through the TCR.
Additionally, belated recognition of the
significance of karst limestone after an
outbreak (e.g., Walkerton, Ontario;
South Bass Island, Ohio) suggests that
States may choose to specify
identification of sensitive aquifers
combined with assessment source water
monitoring to enhance multi-barrier
protection.
  c. Source Water Samples
  i. Source water microbial indicators.
The final GWR requires GWSs that  are
performing triggered source water
monitoring to monitor their ground
water source(s) for one of three fecal
indicators (E. coli, enterococci, or
coliphage). The State must specify
which fecal indicator the GWSs must
test for in their ground water source(s).
EPA recommends that States use these
same requirements for GWSs performing
assessment source water monitoring.
  In this rule, EPA is authorizing the
use of E. coli and enterococci as
bacterial indicators of fecal
contamination. Both of these indicators
are closely associated with fresh fecal
contamination and are found in high
concentrations in  sewage and septage.
Approved analytical methods for these
indicators are commercially available,
simple, reliable, and inexpensive. E. coli
is monitored under the TCR and
therefore GWSs are familiar with its
measurement and interpretation.
Enterococci are recommended as one of
the indicators for fecally contaminated
recreational waters and therefore have
widespread use. Enterococci may be a
more sensitive fecal indicator than E.
coli in certain aquifer settings and
therefore may be the preferred indicator
in such locations.
  EPA is also authorizing the use of
coliphage as a viral indicator of fecal
contamination.  Coliphage are viruses
that infect the bacterium E. coli. They
are closely associated with fecal
contamination because they do not tend
to infect other non-fecal bacteria.
Because they are viruses, their stability
and transport through soil and certain
aquifer types are similar to the fate and
transport of pathogenic viruses. There
are two categories of coliphage—somatic
coliphage and male-specific coliphage.
Local knowledge of hydrogeological
conditions may inform which of the
indicators may be most effective for
identifying fecal contamination
(USEPA, 2006b). EPA plans to publish
a guidance manual to help to inform
such decisions. This rule gives States
the discretion to specify use of E. coli,
enterococci, or one of the coliphage
types to monitor for potential presence
of fecal contamination in ground water
sources.
  ii. Basis for requiring one versus more
than one fecal indicator. EPA's Science
Advisory Board  (SAB) and the National
Drinking Water Advisory Council
(NOWAC) recommended that EPA
require monitoring for coliphage  and
either E. coli or enterococci for source
water monitoring. The reasons stated by
SAB and NOW AC were that (1) Ground"
water occurrence data show that no
single indicator can fully capture all
fecal contamination, (2) coliphage is an
important indicator of enteric virus
contamination in terms of transport and
survival characteristics, and (3) a
significant portion of waterborne
disease risk is associated with exposure
to pathogenic viruses in ground water
sources utilized by a subset of PWSs
(USEPA, 2(H)Oh and 2000i).
  EPA had insufficient data to evaluate
the effectiveness, on a national level, of
using both coliphage and either E. coli
or enterococci as source water
indicators of fecal contamination. While
coliphage data is available for many  of
the occurrence studies used to estimate
national occurrence for E. coli, the
methods used to measure coliphage are
often based on high volume analysis
and a variety of methods different than
those specified under the final GWR.
Thus, EPA could not determine whether
SAB's proposal  would provide
additional effectiveness.
  EPA is concerned with the potential
increase in sampling burden relative to
the additional number of fecally
contaminated wells that would be
identified using two indicators
compared to the use of one indicator.
The analytical cost for coliphage (viral
fecal indicator) monitoring is estimated
to be about two to three times the cost
for bacterial fecal indicator monitoring.
Therefore, requiring a GWS to monitor
for both bacterial and viral fecal
indicators would more than double the
analytical costs for GWSs. Based on the
limited data available, EPA believes that
it is not reasonable to require all GWSs
to monitor for both a bacterial and a
coliphage indicator in their source
water.
  EPA believes that the most
appropriate indicator may vary from
State to State or site to site. This may
be due to regional or site-specific
differences or other reasons that may be
identified by  the State.  EPA intends to
provide guidance on how to determine
which  indicator may be most
appropriate to use.
  For the reasons discussed above, EPA
believes that the use of a single fecal
indicator [E. coli, enterococci, or
coliphage) provides a cost-effective
means  for identifying fecally
contaminated wells and protecting
public  health.
  iii. Sample volume and analytical
methods. This rule requires GWSs
performing triggered source water
monitoring to collect and test at least a
100 mL sample volume. EPA
recommends  that States use this
requirement for assessment source water
monitoring. The final GWR requires a
minimum sample volume of 100 mL
because most utilities are familiar with
this sample volume for bacterial
indicator analysis, and  the two EPA
approved coliphage methods include at
least this volume in their procedures.
EPA believes  that specifying a higher
minimum sample volume would unduly
increase the cost per sample (especially
due to  shipping). Furthermore, if a
higher  minimum sample volume were
specified in the GWR, small systems
would  not be  able to realize the
considerable monitoring cost savings
from use of TCR repeat sampling
previously discussed in Section
IV.B.2.a.ii.
  With regard to analytical methods
used for ground water source
monitoring under this rule, four of the
seven methods for the analysis of E. coli
in source waters allowed under this rule
are consensus methods described in
Standard Methods for the Examination
of Water and  Wastewater (20th editions)
(APHA, 1998). The three E. coli  methods
that are not consensus methods are as
follows: MI agar (a membrane filter
method), the ColiBlue 24 test (a

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65598   Federal Register/Vol.  71, No. 216/Wednesday, November 8, 2006/Rules  and Regulations
membrane filter method), and the
E*Colite test (a defined dehydrated
medium to which water is added). EPA
has already evaluated and approved
these three methods for use under the
TCR. In the proposed rule § 141.403(d),
footnotes 4 and 5, the use of MI agar
with Membrane Filtration Method was
allowed. Membrane Filtration Method is
an EPA-approved drinking water
method, as indicated in footnote 4,
while footnote 5 cites a manuscript
describing MI agar. Subsequent to the
proposal of the GWR, EPA developed
EPA method 1604 "Total Coliforms and
Escherichia coli in Water by Membrane
Filtration Using a Simultaneous
Detection Technique (MI Medium)"
(USEPA, 2002c). This method was
created to ensure consistency with other
EPA microbiological methods and was
promulgated under the Clean Water Act
for use in ambient water monitoring July
21, 2003(68 FR 43272-43283)at 40 CFR
136.3, Table 1A, footnote 22. Method
1604 is equivalent to both the
manuscript and the EPA-approved
Membrane Filtration Method, and EPA
has indicated in Section 5.4.2.1.3 of the
Manual for the Certification  of
Laboratories Analyzing Drinking Water
(USEPA, 2005b) that Method 1604 is
identical. EPA Method 1604 is available
on the  EPA Web site at http://
www.epa.gov/microbes. This rule allows
EPA Method 1604 because the Agency
believes it will be easily available to the
public.
  Three enterococci methods for the
analysis of source water are allowed
under this rule; two of these are
consensus methods in Standard
Methods (APHA, 1998), and  the third
(Enterolert) was published in a peer-
reviewed journal article (Budnick et al.,
1996). The description for each of the E.
coli and enterococci methods explicitly
states that the method is appropriate  for
fresh waters or drinking waters. The
proposed rule, § 141.403(d),  footnote  8
of the table, also proposed to allow EPA
Method 1600 (USEPA, 1997d) as an
approved variation of one of the two
consensus methods, Standard Method
9230C, for enterococci. However,
subsequent to the proposal of the GWR,
EPA slightly modified EPA Method
1600 (USEPA, 2002a) and promulgated
the new version under the Clean Water
Act on July 21, 2003 (68 FR 43272-
43283), at § 136.3, Table 1A, Footnote
25. The revised method replaced the
1997 version on the EPA Web site
(h ttp ://www. epa .gov/'microbes) .EPA
does not regard the changes in the
newer  version of Method 1600 as
substantive and, aside from changes in
format, contact, and grammar, has
indicated the differences between the
two versions in a memo dated March 12,
2004 that is included in the Water
Docket for the GWR. This rule allows
the more recent version of EPA Method
1600 because, and in addition to a few
updates and more clarifications, the
Agency believes that it will be much
more easily available to the public.
  EPA proposed to allow, and continues
to allow under this rule, the use of the
two coliphage methods, U.S. EPA
Methods 1601 and 1602 (USEPA, 2001a,
2001b), for source water testing—a new
two-step enrichment method  (Method
1601) and a single-agar layer method
(Method 1602) recently optimized for
ground water samples. These methods
have been round-robin tested (USEPA,
2003a and b) and the Agency  has also
conducted performance studies, using
10 laboratories, on the two proposed
methods. A full report of each of the two
performance studies is available in the
Water Docket. They are entitled (1)
Results of the Interlaboratory Validation
of EPA Method 1601 for Presence/
Absence of Male-specific (F+) and
Somatic Coliphage in Water by Two-
Step Enrichment (USEPA, 2003a), and
(2) Results of the Interlaboratory
Validation of EPA Method 1602 for
Enumeration of Male-specific (F+) and
Somatic Coliphage in Water by Single
Agar Layer (SAL) (USEPA, 2003b).
  With regard to method cost, EPA
queried seven laboratories that
participated in the round-robin
performance testing  of the proposed
coliphage tests. Based upon this survey,
EPA estir mtes that the coliphage tests
(not inck ding sampling or  shipping
costs) will cost about $59-$65 per test
(DynCorp, 2000). This compares to
about $20-25 for bacterial indicators.
  iv. Invalidation of a fecal indicator-
positive ground water source  sample.
This rule allows the  State to invalidate
a fecal indicator-positive triggered
source water monitoring sample if the
system provides the  State with written
notice from the laboratory that improper
sample analysis occurred, or if the State
determines and documents in writing
that there is substantial evidence that a
fecal indicator-positive ground water
source sample is not related to source
water quality. These provisions are
consistent with the sample  invalidation
criteria under the TCR and  provide a
necessary flexibility  to States.

3. What Were the Key Issues Raised by
Commenters on the Proposed GWR
Source Water Monitoring Requirements?
  a. Triggered source water monitoring.
  i. Use of total coliform-positive result
as a trigger for source water fecal
indicator monitoring. Many commenters
maintained that a single total coliform-
positive sample was too sensitive of a
trigger to prompt a requirement to
collect a ground water source sample.
Among their reasons were that a single
total coliform-positive sample in the
distribution system is not necessarily
linked to any source water problem or
even a public health risk. Some argued
that other triggers were more suitable,
such as an acute MCL violation or a
non-acute MCL violation under the
TCR. A number of commenters were
opposed to triggered source water
monitoring altogether.
  As discussed in Section IV.B.2, EPA
believes that triggered  source water
monitoring is an important requirement
to protect public health. In response to
commenters' concerns that a single total
coliform-positive sample in the
distribution system is not necessarily
linked to any source water problem,
EPA has added language in the final
GWR that allows States to determine
that the cause of a total coliform-
positive collected under § 141.21(a) is
directly related to the distribution
system and will thus not be a trigger for
fecal indicator source water monitoring.
Because the time available to make the
determination is short, the State may
develop criteria for systems to use to
make the determination, which would
be followed by a report to the State.
  Unless clearly indicated otherwise,
EPA believes that a total coliform-
positive sample in the distribution
system is an indication of potential
microbial contamination of the GWS
that may have originated from the
ground water source. This is a
potentially serious public health risk
that warrants follow-up action.
  EPA believes that basing triggered
source water monitoring on TCR MCL
violations would not be sensitive
enough to identify the majority of fecal
contamination events at the  source. EPA
estimated that the percentage of fecally
contaminated wells that would be
identified under such a provision would
be an order of magnitude less than
under the requirements of the final rule.
Consequently, EPA believes that such a
requirement would not be adequately
protective.
  ii.  Consecutive system and wholesale
system requirements. EPA requested
comment on which GWR requirements
should apply to consecutive systems
and specifically who should be
responsible for triggered source water
monitoring after a total coliform-
positive sample is found in the
consecutive system's distribution
system. Many commenters
recommended that the seller (or
wholesale)  system be responsible for

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           Federal  Register/Vol. 71, No. 216/Wednesday, November  8, 2006/Rules and Regulations   65599
ground water source monitoring, not the
consecutive system. Others suggested
the State should decide which system
should take the ground water source
sample. In addition, some commenters
maintained that the buyer (or
consecutive) system should not be
responsible for meeting the treatment
technique requirements (e.g., 4-log
treatment) for sources.
  EPA infers that some commenters
based their comments on an
understanding that consecutive systems
were only systems that received all their
finished water from a wholesale system,
although that is not always correct.
Since the GWR proposal, EPA defined
"consecutive system" and "wholesale
system" in § 141.2 in the Stage 2
Disinfectants and Disinfection
Byproducts Rule (DBPR) (71 FR 388,
January 4, 2006) (USEPA, 2006g). In
those definitions, which apply to all
requirements in 40 CFR Part 141
(including the GWR), EPA specified and
clarified that consecutive systems
include both systems that receive all of
their finished water from one or more
wholesale systems and systems that
receive some of their finished water
from one or more wholesale systems
(with the balance coming from a source
or sources operated and treated, as
necessary, by the consecutive system).
  The Agency has added requirements
to clarify the responsibilities of
consecutive and wholesale systems in
response to comments received, and to
facilitate implementation and
compliance. EPA believes that public
health and risk concerns underlying the
requirement for triggered ground water
source monitoring after a total coliform-
positive sample are equally  applicable
to consecutive systems and wholesale
systems. EPA also believes that the
system that operates the ground water
source should be responsible for any
required triggered or assessment source
water monitoring and any required
corrective actions, including 4-log
treatment installation, operation, and
compliance monitoring.
  Without treatment, water  quality
problems in the wholesale system will
remain in the water delivered to the
consecutive system and thus water
quality problems in the consecutive
system may be related to problems in
the wholesale system (even if the
wholesale system has not identified the
problems), therefore, in the GWR,
specific triggered source water
monitoring requirements apply to
consecutive  systems and wholesale
systems (as explained in the following
paragraphs) unless the cause of the  total
coliform-positive collected under
§ 141.21(a) directly relates to the
distribution system as determined by
the system according to State criteria, or
as determined by the State.
  Consecutive systems that have a total
coliform-positive sample must notify
the wholesale system(s) within 24 hours
of being notified of the total coliform-
positive sample so that the wholesale
system(s) can conduct triggered source
water monitoring, since the wholesale
system's source water may be the cause.
Also, a consecutive system with its own
ground water source(s) that has a total
coliform-positive sample under the TCR
must conduct triggered source water
monitoring of its own sources, just like
any other GWS that must conduct
triggered source water monitoring. A
consecutive system that has no source of
its own (i.e., it receives all of its finished
water from one or more wholesale
systems) is not required to conduct
triggered source water monitoring, since
it has no source water. Only systems
that produce finished ground water (i.e.,
have their own sources) are required to
conduct triggered source water
monitoring.
  Consecutive systems are required to
comply with the GWR treatment
technique requirements only in cases of
contamination in the consecutive
system's own ground water source.
Consecutive systems are not required to
comply with GWR treatment technique
requirements if a fecal indicator-positive
is detected only in the wholesale
system's ground water source; only the
system with the source contamination
must comply with the GWR treatment
technique requirements (in this case, the
wholesale system). Similarly, wholesale
systems are not required to comply with
GWR treatment technique requirements
if a fecal indicator-positive is detected
only in the consecutive system's ground
water source and not in the wholesale
system's source; again, only the system
with the source contamination must
comply with the GWR treatment
technique requirements (in this case, the
consecutive system).
  iii. Repeat samples to confirm initial
fecal indicator-positive. Several
commenters raised concerns that a
single positive fecal indicator source
water sample should not result in a
corrective action because the indicator
sample result may be a false positive.
The same commenters recommended
that repeat samples be taken to confirm
the initial result before requiring
corrective action.  In response to
commenters and based on the
discussion in Section IV.B.2, unless the
State determines that corrective action
should be taken following an initial
fecal indicator-positive source water
sample, the final GWR requires that the
GWS take five additional samples, and
that only if one of those samples is fecal
indicator-positive is corrective action
required. This prevents systems from
incurring costs from the application of
unnecessary corrective actions. The
State may require the system to take
corrective action after the first fecal
indicator-positive source water sample.
  EPA believes that five additional
samples following a positive triggered
source water monitoring sample
provides a reasonable balance between
ensuring that corrective actions are
warranted, avoiding excessive re-
sampling costs, and avoiding an
incorrect conclusion that the initial
positive was false (i.e., avoiding a
situation in  which corrective action is
needed but not taken because of false re-
sample results). EPA believes that
multiple samples, rather than one, are
needed to ensure  that corrective action
is taken when  necessary. EPA proposed
using five repeat samples under the
routine monitoring provisions (65  FR
30230) (USEPA, 2000a). Commenters
wanted EPA to use repeat samples for
the triggered monitoring provisions also
because they were concerned about false
positives and systems taking
unnecessary corrective actions. They
recommended four or five repeat
samples for  triggered monitoring. In
response to  comments, the final GWR
requires five repeat samples under the
triggered source water monitoring
provisions.
  iv. Source water monitoring burden.
In the final GWR,  EPA has reduced the
sampling burden for small systems
serving 1,000 people or fewer. Under
the TCR, a system that collects one or
fewer routine samples per month
(systems that serve 1,000 people or
fewer) with  a total coliform-positive
sample  (that has not been invalidated) is
already required to collect a set of four
repeat samples in the distribution
system within 24 hours of the total
coliform-positive  sample. Under this
rule, one of the four repeat samples
required under the TCR may be used to
satisfy the GWR source water
monitoring requirements if the sample
is taken at a  ground  water source and
only if the State approves the use of E.
coli as a fecal indicator.
  In addition, the final rule reduces
sampling burden for systems with more
than one well (e.g., many large systems).
Based on comments received, the GWR
provides flexibility for systems with
more than one well. The triggered
source water monitoring provision
allows systems with more than one
ground water source, upon State
approval, to  sample a representative
ground water source (or sources)

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65600   Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations
following any total coliform-positive
sample. The State may require systems
with more than one ground water source
to submit for approval a triggered source
water monitoring plan that the system
will use for representative sampling.
EPA believes that this alternative can be
as protective of public health as
monitoring all wellheads, provided that
the chosen wells are truly representative
of all wellheads. In addition, for
situations where a particular sample site
is inaccessible, the State may identify an
alternate sampling site that is
representative of the water quality of the
ground water at the inaccessible sample
site.
  b. Routine Monitoring. Many
comments regarding routine source
water monitoring were related to HSAs.
Many commenters suggested State
discretion on which systems should be
considered sensitive and thus be
required to do routine monitoring.
  EPA has taken public comments on
routine monitoring and HSAs into
consideration, as discussed in Section
II.C. The final GWR provides State the
option to require assessment source
water monitoring at GWSs that the State
determines to be most susceptible to
fecal contamination. EPA believes that
this optional provision is an important
tool that should be used by States to
protect public health.
  EPA recommends HSAs as one way to
identify higher risk systems for which
assessment source water monitoring
would be beneficial and appropriate.
Based on comments received, the final
GWR does not require HSAs or
assessment source water monitoring,
except as provided by the State (see
Section II.C).
  c. Source water microbial indicators
and analytical methods. This rule
allows a State to direct a system to use
E. coli, enterococci, or coliphage for
ground water source monitoring.
Regarding coliphage testing, one major
issue raised by commenters pertained to
the performance of the two proposed
coliphage methods. Many commenters
questioned method reliability,
specificity, sensitivity, false-positive
rates, and lack of comprehensive field
testing. They were also concerned about
analytical costs and the availability of
laboratory capacity. As explained
earlier, the Agency believes that the
results of performance studies indicate
that both methods have been validated
for reliable use in drinking water
contexts. As discussed in Section
IV.B.2, EPA recognizes that the
analytical costs for coliphage testing are
more than double the cost for bacterial
(E. coli and enterococci) analyses.
Therefore, EPA believes that many
States will specify a bacterial fecal
indicator for GWR source water
monitoring based on cost. However, the
Agency allows coliphage testing in this
rule due to awareness that some
laboratories are proficient in coliphage
analysis and that this indicator may be
preferred over others, depending on
site-specific knowledge. While EPA
recognizes that limited laboratory
capacity for coliphage testing may be an
issue, this rule provides States with
discretion in determining which fecal
indicators (E. coli, enterococci, or
coliphage) will be used. EPA expects
that one of the factors that States may
use to decide which fecal indicator to
specify is laboratory capacity.
C. Corrective Action Treatment
Techniques for Systems With Significant
Deficiencies or Source Water Fecal
Contamination
  The final GWR provides for regular,
comprehensive sanitary surveys of all
GWSs and triggered source water and
optional assessment source water
monitoring to determine at-risk GWSs.
This rule requires the subset of systems
with sanitary survey significant
deficiencies or source water  fecal
contamination to complete corrective
actions in a timely manner to ensure
public health protection. Failure to
complete corrective actions within 120
days, including meeting deadlines for
interim actions and measures, or
comply with a State-approved corrective
action plan and schedule, constitutes a
treatment technique violation under this
rule.
BILLING CODE  6560-50-P

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          Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations    65601

          Figure IV-3: Corrective Action Treatment Technique Requirements
                                         Significant Deficiency Identified
                                          or Corrective Action Required
                                           (See Figures IV-1 and IV-2)
                                      State requires a specific corrective action
                                                        or
                                     GWS must consult with the State within 30
                                     days of notification of significant deficiency
                                             or fecal indicator-positive
                                     Within 120 days of notification of significant
                                   deficiency or fecal indicator positive (or earlier if
                                         directed by the State) GWS must:

                                      Complete appropriate corrective actions
                                                       or
                                  Be in compliance with a State-approved schedule
                          Corrective Action options are:
                            (1) correct all significant deficiencies
                            (2) provide an alternate source of water
                            (3) eliminate the source of contamination*
                            (4) provide treatment that reliably achieves at least 4-log
                               treatment of viruses
                           If GWS provides 4-log treatment of viruses, it must install,
                           operate, and monitor one of the following to demonstrate
                           compliance:
                            •  Inactivation through disinfection,
                            •  Removal with membrane technologies, or
                            •  Inactivation, removal or combination of inactivation and
                               removal through alternative treatment technologies.
               * If the State and GWS cannot determine the cause of the source water contamination, and
               the State determines based on follow-up monitoring or other evidence that the
               contamination is unlikely to occur again,  the State may determine that the source of
               contamination has been eliminated.
BILLING CODE 6560-50-C

1. What Are the Requirements of This
Rule?

  When a system has a significant
deficiency, it must consult with the
State regarding appropriate corrective
action within 30 days of receiving a
written notice of the significant
deficiency. When a system receives a
written notice from a laboratory
indicating a fecal indicator positive
result in one of the five additional
triggered source water monitoring
samples, the system must consult with
the State regarding appropriate
corrective action. When a system
receives a written notice from a
laboratory indicating a fecal indicator

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65602    Federal Register/Vol.  71,  No. 216/Wednesday,  November 8, 2006/Rules and Regulations
positive result and the State has
determined that corrective action is
necessary, the system must consult with
the State regarding appropriate
corrective action. Consultation must
take place within 30 days. In any event,
the State may specify corrective action
without consultation. In the
consultation process, the State may
approve and/or modify corrective
actions and completion schedules
proposed by the system, or the State
may specify alternatives. The State may
also specify interim corrective action
measures.
  The GWR rule requires that within
120 days (or earlier if directed by the
State) of receiving the notification from
the State or laboratory described in the
preceding paragraph, the GWS must
either (i) Complete appropriate
corrective actions in accordance with
applicable State plan review processes
or other State guidance or direction, or
(ii) be in compliance with a State-
approved corrective action plan and
schedule. If a system is unable to
complete corrective action within 120
days or on the schedule specified by the
State, then the system is in violation of
the treatment technique requirement.
  Systems must notify the State within
30 days of completing any State
approved or specified corrective action.
As a condition of primacy, States must
verify that the corrective action has been
completed within the next 30 days.
States may verify that the corrective
action has been completed and has
successfully addressed  the significant
deficiency and/or fecal contamination
in the ground water source either by a
site visit or by written documentation
from the system, which could consist of
the system's notification to the State.
  a. What corrective action alternatives
are provided for in this rule? When a
system has a significant deficiency or a
fecal indicator-positive ground water
source sample (either by the initial
triggered sample, or positive additional
sample, as determined by the State), the
GWS must implement one or more of
the following corrective action options:
(1) Correct all significant deficiencies
(e.g., repairs to well pads and sanitary
seals, repairs to piping tanks and
treatment equipment, control of cross-
connections); (2) provide an alternate
source of water (e.g., new well,
connection to another PWS); (3)
eliminate the source of contamination
(e.g., remove point sources, relocate
pipelines and waste disposal, redirect
drainage or run-off, provide or fix
existing fencing or housing of the
wellhead); or (4) provide treatment that
reliably achieves at least 4-log treatment
of viruses (using inactivation, removal,
or a State-approved combination of
4-log virus inactivation and removal)
before or at the first customer for each
ground water source requiring
corrective action.
  b. Compliance monitoring for systems
providing at least 4-log treatment of
viruses. This rule also establishes
compliance monitoring requirements for
GWSs that provide at least 4-log
treatment of viruses as a corrective
action. This rule also establishes
compliance monitoring requirements for
those systems that have notified the
State that they provide at least 4-log
treatment of viruses for their ground
water sources before the first customer
and are therefore not  required to meet
the triggered source water monitoring
requirement of this rule.
  Treatment technologies capable of
providing at least a 4-log treatment of
viruses include the following:
  • Inactivation, with a sufficient
disinfection concentration and contact
time, through disinfection with
chlorine, chlorine dioxide, ozone, or
through anodic oxidation. Disinfectant
concentration and contact time (CT) can
be based on  existing CT tables (USEPA,
1991) or State-approved alternatives.
  • Removal with membrane
technologies with an absolute molecular
weight cut-off (MWCO), or an alternate
parameter that describes the exclusion
characteristics of the  membrane, that
can reliably  achieve at least a 4-log
removal of viruses.
  • Inactivation, removal or
combination of inactivation and
removal through alternative treatment
technologies (e.g., ultraviolet radiation
(UV)) approved by the State, if the
alternative treatment technology, alone
or in combination (e.g., UV with
filtration, chlorination with filtration),
can reliably  provide at least 4-log
treatment of viruses.
  Under this rule, systems providing 4-
log treatment of viruses using chemical
disinfection must monitor for and must
meet and maintain a State-determined
residual disinfectant  concentration (e.g.,
4-log inactivation of viruses based on
CT tables) or State-approved alternatives
every day the GWS serves from the
ground water source to the public.
  Systems serving greater than 3,300
people and using chemical disinfection
(e.g., chlorine) to provide 4-log
inactivation must continuously monitor
the residual disinfectant concentration
using analytical methods specified in
§141.74(a)(2) (Analytical and
monitoring requirements) at a location
approved by tbe State, and record the
lowest residual disinfectant level each
day that the GWS serves water from the
ground water source to the public. The
system must maintain the State-
determined residual disinfectant
concentration every day the GWS serves
from the ground water source.
  Systems serving 3,300 people or fewer
that use chemical disinfection must
monitor the residual disinfectant
concentration using analytical methods
specified in § 141.74(a)(2) (Analytical
and monitoring requirements) at a
location approved by the State either by
taking at least one grab sample every
day the GWS serves water to the public
or by continuously monitoring the
disinfectant residual. Systems collecting
grab samples must record the
disinfectant residual level each  day that
the GWS serves water from the ground
water source to the public. The  system
must take a grab sample during  the hour
of peak flow or at another time specified
by the State. Systems serving 3,300
people or fewer that use continuous
residual monitoring equipment  must
record the lowest residual disinfectant
level each day that the GWS serves
water from the ground water source to
the public.
  If a GWS taking grab samples  has a
sample measurement that falls below
the State-specified residual disinfectant
concentration, then the system must
take follow-up samples at least every
four hours until the State-specified
residual disinfectant level is restored. If
a system using continuous monitoring
equipment fails to maintain the State-
specified disinfectant  residual level
necessary to achieve 4-log inactivation
of viruses, the system  must restore the
disinfectant residual level to the State-
specified level within four hours. If
continuous disinfectant monitoring
equipment fails, the GWS must  take a
grab sample at least every four hours
until the equipment is back on-line. The
system has 14 days to  resume
continuous monitoring. Failure  to
restore the residual disinfectant level to
that required for 4-log inactivation of
viruses within four hours, using either
continuous monitoring or grab
sampling, is a treatment technique
violation.
  Ground water systems that use a
membrane filtration treatment
technology must maintain the integrity
of the membrane and monitor and
operate the membrane filtration system
in accordance with State-specified
monitoring and compliance
requirements (e.g., membrane
performance parameters and integrity
testing). If a system fails to meet these
requirements or maintain the integrity
of the membrane, it must correct the
problem within four hours or be in
violation of the treatment technique
requirement.

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           Federal  Register/Vol.  71,  No. 216/Wednesday,  November 8, 2006/Rules and  Regulations    65603
  Systems that use a State-approved
alternative treatment technology must
monitor and operate the alternative
treatment in accordance with all
compliance requirements that the State
determines to be necessary to
demonstrate that at least 4-log treatment
of viruses is achieved. If the system does
not comply with these requirements,
fails to maintain at least 4-log treatment
of viruses, and does not restore proper
operation within four hours, the system
is in violation of the treatment
technique requirement.
  GWSs providing at least 4-log
treatment of viruses may discontinue
treatment if the State determines (e.g.,
based on source water monitoring or
replacement of the source) and
documents in writing that the need for
4-log treatment of viruses no longer
exists for that ground water source.
GWSs that discontinue treatment with
State approval must comply with the
triggered source water requirements of
this rule. GWSs that provide 4-log
treatment of viruses and notify the State
that they are not subject to the source
water monitoring requirements of this
rule but subsequently discontinue 4-log
treatment of viruses must have State
approval and must comply with the
triggered source water requirements of
this rule.

2. What Is EPA's Rationale for the GWR
Treatment Technique Requirements?
  EPA believes that fecal contamination
in ground water sources of
undisinfected or minimally disinfected
GWSs and significant deficiencies
demonstrate public health risks that
require prompt corrective action.
Application of corrective actions in
cases of source water fecal
contamination or significant
deficiencies provides benefits of
eliminating existing problems and can
also preempt  future public health risks,
such as an outbreak. EPA believes that
requiring treatment technique
provisions to  respond to fecally
contaminated ground water sources
and/or significant deficiencies
identified by  sanitary surveys will
provide enforcement authority to EPA
and States to  ensure that appropriate
corrective actions will be implemented.
  The GAO reported that failure to
correct deficiencies identified in
sanitary surveys is a significant concern
(USGAO, 1993). An analysis of Best
Management  Practices (BMPs) (ASDWA,
1998) showed that correction of
deficiencies was correlated with lower
levels of total coliform, fecal coliform,
and E. coli. Therefore, EPA believes that
the  treatment technique requirements in
this rule will  result in reduced
exposures to fecal contamination and
associated health risks.
  Findings from a review of the
Environmental Law Reporter contained
in the Baseline Profile Document for the
Ground Water Rule (USEPA, 2000g)
indicate that (1) Not all States
specifically require systems to correct
deficiencies, and (2) a number of States
may not have the legal authority to
require systems to correct deficiencies.
The treatment technique requirements
of this rule provide for timely
correction, as well as public
notification, of fecal contamination and
significant deficiencies.  Treatment
corrective actions provide for
inactivation or removal of microbes of
public health concern in some ground
waters and results in reduced exposures
and associated health risks. The rule
also allows non-treatment alternatives
such as removing the source of
contamination or providing an alternate
source water, both  of whicb also result
in reduced exposures and associated
health risks.
  To avoid unwarranted action, EPA
has added a provision under the final
rule that allows additional sampling of
the source water with the initial fecal
indicator-positive sample before
requiring corrective action. If the State
determines that corrective action is
appropriate from the initial fecal
indicator-positive finding, then no
additional sampling would be required.
This provision is discussed in Section
IV.B.2.a.
  a. Corrective Actions and Treatment
Technique Requirements. To develop
the treatment technique  requirements,
EPA evaluated existing State
requirements and the measures
available to systems to address fecal
contamination. EPA believes that
effective corrective actions include
correcting significant deficiencies,
eliminating the source of contamination,
providing an alternate source of safe
drinking water, or providing 4-log
treatment of viruses. States and systems
have the flexibility to take site-specific
factors into consideration when
implementing these corrective actions.
  i. Corrective action technologies.
Chemical disinfection technologies are
commonly  used by both  ground water
and surface water systems to provide
disinfection prior to distribution of
drinking water. EPA believes that 4-log
inactivation is protective in disinfecting
GWSs (see Figure III-l).  Under the
SWTR, EPA requires at least 4-log
removal and/or inactivation of viruses.
Since the frequency of viral occurrence
and virus concentrations are generally
lower in ground water supplies than in
surface water supplies, EPA believes the
4-log requirement for GWSs is as
protective as the current treatment
requirements for surface water supplies.
Figure III-l indicates the range of
protection anticipated from the 4-log
requirement for GWSs having viral
contamination in their source water.
  Numerous studies have investigated
the efficacy of chemical disinfectants to
inactivate viruses. Free chlorine was
shown to be able to achieve 4-log
inactivation of hepatitis A virus (HAV)
at a temperature of 15 degrees Celsius,
a pH of 6-9, and a CT of four mg-min/
L (USEPA, 1991). Chlorine dioxide
achieves 4-log inactivation of HAV at a
temperature of 15 degrees Celsius, a pH
of 6-9, and a CT of 16.7 mg-min/L
(USEPA, 1991). Ozone achieves a 4-log
inactivation of poliovirus at a
temperature of 15 degrees Celsius, a pH
of 6-9, and a CT of 0.6 mg-min/L
(USEPA, 1991). Chemical disinfection is
a demonstrated technology that can
achieve 4-log inactivation of viruses.
The CT value needed to provide 4-log
inactivation of viruses is dependent on
site-specific conditions, including the
disinfectant demand, water temperature
and pH. States and systems may use
existing inactivation (CT) tables
(USEPA, 1991) or State-approved
alternatives to determine the chemical
disinfectant doses required to achieve a
4-log inactivation of viruses.
  Membrane filtration technologies can
achieve 4-log or greater removal of
viruses, as long as the absolute MWCO
of the membrane, or alternate parameter
that describes the exclusion
characteristics of the membrane, is
smaller than the diameter of viruses. For
instance, reverse osmosis (RO) can
achieve greater than 4-log removal of
particles (including viruses) larger than
0.5 nm in diameter when the absolute
MWCO of the RO membrane is less than
0.5 nm (Jacangelo et al., 1995). In
addition, nanofiltration (NF) can
achieve greater than 4-log removal of
particles with a diameter of 0.5 nm or
larger when the absolute MWCO of the
NF membrane is 200-400 Daltons.
Viruses range in diameter from 20-900
nm. The absolute MWCOs of specific
membranes must be determined for the
specific membranes to meet these
conditions. This rule also allows for
other filtration treatment technologies to
be used to meet the 4-log treatment
requirement.
  The GWR proposal explicitly
included UV light in the regulatory text
as a stand-alone treatment technology
that could provide a 4-log virus
inactivation. However, data published
subsequent to the GWR proposal
indicated that some viruses, particularly
adenoviruses, are very resistant to UV

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65604   Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations
light. The GWR proposal was based on
information available at the time of the
proposal regarding UV doses required to
provide a 4-log inactivation of HAV and
the design doses achieved by available
UV reactors, which are lower than the
UV doses needed to achieve 4-log
inactivation of adenovirus.
  Further, EPA believes that UV
reactors must undergo challenge testing
to validate the dose level delivered so
that effective public health protection is
provided in systems using UV
disinfection. At present, EPA is unaware
of available challenge testing procedures
that can be used to validate the
performance of UV reactors at dose
levels needed for a 4-log inactivation of
adenovirus.
  The final GWR modifies the proposal
by removing the explicit reference to UV
as a stand-alone technology to achieve
4-log virus inactivation.  EPA is
concerned that fecally-contaminated
ground water may contain adenoviruses,
or other viruses, that are more resistant
to UV inactivation  than HAV, and
currently available testing procedures
cannot validate UV reactor performance
at the UV dose levels needed for
inactivation.
  EPA believes that UV technology can
be used in a series configuration or in
combination with other inactivation or
removal technologies to provide a total
4-log treatment of viruses to meet this
rule's requirements. EPA also believes
that a UV reactor dose verification
procedure for 4-log inactivation of a
range of viruses may be developed in
the future. With the future development
of UV validation procedures, it may
become feasible for systems to
demonstrate that they  can achieve 4-log
inactivation of viruses with a single UV
light reactor. Therefore, this rule allows
States to approve and set compliance
monitoring and performance parameters
for  any alternative treatment, including
UV light or UV light in combination
with another treatment technology, that
will ensure that systems continuously
meet the 4-log virus treatment
requirements. This requirement is both
protective of public health and provides
systems and States with needed
flexibility for site-specific decisions. It
ensures protection against known heath
risks associated with waterborne
viruses; allows systems to make use of
technologies that are already in place or
are more appropriate for the system's
size, location, or configuration; and
provides the opportunity for systems to
take advantage of future technology
developments.
  ii. Corrective action time  frame. EPA
believes that timely correction of source
water fecal contamination and
significant deficiencies in GWSs is an
essential component of the public
health measures presented in this rule.
  EPA has extended the proposed 90-
day deadline for completing corrective
actions to 120 days, which includes
additional time for a 30-day GWS/State
consultation period. In the case of
source water fecal contamination, an
investigation into the cause of
contamination should be conducted
during this 30 day period. This
consultation allows the State, in
discussion with the system, to
determine the most appropriate
corrective action for the problem
identified to ensure public health
protection.  To reduce burden, the State
may specify the corrective action in its
significant deficiency notice to the
system.
  EPA believes that in many situations,
a system can complete corrective
actions within 120 days because many
corrective actions are easy to
implement, such as repairing a well
seal. Where this is not the case, for
example if a system needs to make
capital improvements, the GWR allows
States to determine an alternate
schedule. The State is in the best
position to make these case-by-case
determinations of the most appropriate
schedule to protect public health. The
GWR also allows the State to require
immediate interim corrective action to
protect consumers while longer-term
actions are implemented.
  There may be cases in which systems
and States have thoroughly investigated
and cannot determine the cause of fecal
contamination of the source water and
believe that the source is no longer
vulnerable to such  contamination. If the
State determines based on follow-up
monitoring or other evidence that the
contamination is unlikely to occur
again, the State may consider the source
of contamination to be eliminated. EPA
considers such a system to be high risk
and recommends that States follow up
such a determination with assessment
source water monitoring as described in
Section  IV.B.2.b. Commenters supported
State discretion in making system-
specific decisions.  EPA is providing this
interpretation in support of this goal.
  iii. Discontinuing treatment. If  the
State determines that the need for 4-log
treatment no longer exists, the State may
allow a  system to discontinue treatment.
EPA believes that in certain situations
(i.e., consolidation, replacement or
rehabilitation of ground water sources,
mitigation of source of contamination),
where both corrective action has
addressed the public health risks and
the system has demonstrated to the
State that corrective action has been
successful (e.g., through source water
monitoring or sanitary surveys), it may
be appropriate to allow systems to
discontinue 4-log treatment of ground
water sources. If the State allows a
system to discontinue 4-log treatment,
the system is  then subject to the source
water monitoring requirements of this
rule.
  b. Monitoring for the Effectiveness
and Reliability of Treatment. All GWSs
that provide treatment must routinely
monitor the treatment effectiveness to
ensure that public health is protected.
Because of considerations regarding
resources and the technical capacities  of
small water systems, this rule includes
different monitoring requirements for
systems of different sizes while still
effectively ensuring public health
protection. The 1996 Amendments to
the SDWA recognized the importance  of
considering both the  special needs of
small systems that serve 3,300 people  or
fewer and the need to ensure equal
public health protection to consumers
served by small and large PWSs.
  EPA believes that it is appropriate for
disinfecting systems serving greater than
3,300 people  to install and operate
continuous disinfection monitoring
equipment. These systems will
generally have the expertise to operate
and maintain the necessary equipment,
and continuous monitoring and
recording will alleviate some of the
monitoring burden for larger systems.
Systems serving 3,300 people or fewer
are provided the flexibility to use either
grab sampling or continuous
monitoring. This option is important
because some small systems may not
have the capacity to purchase, operate,
and maintain continuous disinfection
monitoring equipment. For all systems,
the monitoring must take place at or
prior to the first  customer to ensure that
the required level of treatment has been
achieved prior to serving water to the
public.
  For GWSs that use membrane
filtration systems to achieve at least
4-log removal of viruses, the system
must monitor the membrane filtration
process in accordance with all State-
specified monitoring requirements. In
addition, the  system must operate the
membrane filtration in accordance with
all State-specified compliance
requirements. A GWS that uses
membrane filtration is in compliance
with the 4-log removal requirement for
viruses when:
  • The  membrane has an absolute
MWCO, or alternate parameter that
describes the exclusion characteristics
of the membrane, that can reliably
achieve 4-log removal of viruses;

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           Federal  Register/Vol.  71, No. 216/Wednesday, November  8,  2006/Rules  and Regulations    65605
  • The membrane process is operated
in accordance with State-specified
compliance requirements; and
  • The integrity of the membrane is
intact.
To ensure compliance with the virus
removal requirements of the GWR in
systems that practice membrane
filtration, systems must monitor to
verify that the membrane filtration is
operating as specified and that the
membrane is intact. Without these
compliance monitoring requirements,
failure of membrane filtration may not
be detected by the system and
consumers may be exposed to
potentially fecally contaminated water.
This could result in a failure to maintain
at least 4-log treatment of viruses.
  In cases where 4-log treatment of
viruses  is interrupted, the requirement
that systems must restore 4-log
treatment of viruses is consistent with
requirements for surface water systems
under the SWTR (USEPA, 1989b) and
protects public health while providing
flexibility for GWSs to address
operational issues.
  If the State has not approved
compliance criteria for the system to use
to demonstrate 4-log treatment by  the
time that the system is required to
conduct compliance monitoring, the
system should comply with ground
water source monitoring in § 141.402
until the State approves compliance
criteria for the system to use to
demonstrate 4-log treatment. EPA  is
concerned that systems may
inadvertently provide inadequately
treated water (i.e., < 4-log treatment) if
they are not using State approved
compliance criteria.

3. What Were the Key Issues Raised by
Commenters on the Proposed GWR
Treatment Technique Requirements?
  a. State Consultation Versus
Approval. EPA received many
comments related to the State's ability
to require the system to implement a
specific treatment technique in response
to significant deficiencies or source
water fecal  contamination. The
proposed GWR required the system only
to consult with the State on the
appropriate corrective action option for
the system. Several commenters
expressed concern that with only a
consultation requirement, a system
could implement a treatment technique
that the State would consider
inappropriate or unreliable, such as  •
disinfection by a system that is
incapable of reliably operating a
disinfection treatment system. To
address these concerns, the final GWR
requires systems to implement
corrective actions in accordance with
applicable State plan review processes,
or other State guidance or direction,
including interim measures, or be in
compliance with a State-approved
corrective action plan and schedule.
EPA believes that existing State plan
review and permitting activities, such as
those established in accordance with  the
primacy requirements at § 142.10(b)(5),
will ensure that systems implement the
most appropriate corrective action.
  b. UVDisinfection. EPA received
comments on the use of UV technology
to meet the treatment technique
requirements of the GWR. The GWR
proposal included  UV as a stand-alone
treatment to meet the GWR treatment
requirements and provided monitoring
requirements for systems using UV
technology, as well as State-determined
performance requirements for UV
technology.
  Commenters requested more
information on the use of UV for virus
inactivation, including UV dose tables
and criteria to assist States in evaluating
UV reactors. Commenters also noted
that data published subsequent to the
GWR proposal indicated that some
viruses, in particular adenoviruses, are
very resistant to UV light. Data show
that a dose of 186 mj/cm2 is required  to
achieve 4-log inactivation of adenovirus
(68 FR 47713, August  11, 2003) (USEPA,
2003c). This information suggests that
HAV, the virus considered in the GWR
proposal discussion of UV, may not be
an appropriate indicator of the virus
inactivation performance of UV reactors.
EPA agrees that UV reactors may need
to provide higher doses than those
contemplated in the GWR proposal to
achieve 4-log inactivation of viruses.
Moreover, there is currently limited
information available for States to make
determinations regarding performance
requirements for UV reactors to ensure
that adequate virus inactivation is heing
achieved.
  Further, EPA believes that testing of
full-scale UV reactors is necessary to
ensure disinfection performance and a
consistent level of public health
protection. Full-scale testing avoids the
significant difficulties encountered in
predicting UV reactor disinfection
performance based solely on modeled
results or the results of testing at a
reduced scale. All flow-through UV
reactors deliver a distribution of doses
due to variations in light intensity
within the UV reactor  and the different
flow paths of particles passing through
the reactor. The reactor-delivered dose
also varies temporally due to processes
such as UV lamp aging and fouling,
changes in UV absorbance of the water
being treated, and fluctuations in reactor
flow rates.
  A full-scale test typically involves
using a surrogate microorganism.
However, EPA is not aware of an
available challenge microorganism that
allows for full-scale testing of UV
reactors to demonstrate a 4-log
inactivation of adenovirus. EPA believes
that methodologies for challenge testing
at doses necessary to inactivate UV-
resistant viruses may be developed in
the future.
  The final GWR does not include
specific performance, monitoring, or
design requirements related to the use of
UV technology. This is based on the
comments received regarding the use of
UV technology to meet the GWR
requirements, new data regarding UV
dosages necessary for virus inactivation,
and the difficulties in performing full-
scale demonstrations of 4-log virus
inactivation at those doses.
  However, EPA does believe that UV
technology may  be used in a series
configuration or in combination with
other inactivation or removal
technologies to provide a total 4-log
treatment of viruses to meet this rule's
requirements. The State has the
flexibility to approve treatment
alternatives not specified in the rule,
which could include UV disinfection.
When using an alternative treatment
technology, the State must specify
monitoring and compliance
requirements necessary to ensure that
the virus treatment requirements of this
rule are being met. The alternative
treatment option in this rule could be
applied to stand-alone UV disinfection
if challenge testing protocols for 4-log
virus inactivation are developed in tbe
future.
  c. Corrective Action Time Frame. EPA
requested comment on the
appropriateness  of the time frame for
providing corrective actions. Several
commenters suggested that the proposed
90-day corrective action time frame was
too short and that systems would not be
able to meet this deadline. Some
commenters also stated that 90 days
would not be sufficient for systems
seeking an extension of the 90-day
deadline for completing the corrective
action to obtain State approval of a plan
and schedule within 90 days due to
factors outside of the system's control,
such as the need to obtain competitive
bids or to gain the approval of the local
government. On  the other hand, several
commenters stated that a 90-day
corrective action time frame for systems
with fecally contaminated source water
was too long and would place
consumers at an  increased risk.
  EPA received additional comments
opposing the requirement on the State
to approve corrective action plans

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65606    Federal Register/Vol. 71, No. 216/Wednesday, November 8, 2006/Rules and Regulations
within the same 90 days required for the
system to submit the plans (for systems
seeking an extension of the 90-day
deadline for completing the corrective
action). The commenters pointed out
that under the proposed rule, systems
could potentially submit plans on the
90th day, leaving insufficient time for
the State to review the plans.
  The final GWR extends the proposed
90-day deadline for completing
corrective actions from 90 to 120 days,
which includes additional time for an
initial 30-day GWS/State consultation
period. This 30-day consultation serves
a number of purposes. First, GWSs and
States can investigate the cause of
contamination. Second, the GWS and
State may consult on the most
appropriate corrective action. Third, the
GWS and State may develop a corrective
action plan and schedule that could
extend beyond the 120-day period if
necessary. This addresses the concerns
that GWSs would not be able to
complete their corrective action or
receive an extension. This consultation
period provides the GWS and State the
assurance requested by commenters that
they not be subject to factors outside of
their control. Concerns about corrective
action taking too long have been
addressed by the provision to require
GWSs to do interim corrective action
measures at the State's request. In
addition, this rule requires States to
identify in their primacy application
their rules or other authorities to
demonstrate that they can ensure that
GWSs take the appropriate corrective
action, including interim measures, if
necessary, pending completion of
corrective actions.
  EPA believes that the revised process
for corrective actions under this rule
will (1) Allow the State to ensure that
the system is held accountable in a
reasonable time frame for implementing
corrective actions, and (2) utilize the
strengths of existing State plan review
processes or other State guidance,
requirements,  or direction. Systems and
States continue to have the flexibility to
complete corrective action on a more
rapid schedule than 120 days.

D. Providing Notification and
Information to the Public
  Section 1414(c)(l)  of the 1996 SDWA
amendments requires that PWSs notify
persons served when violations of
drinking water standards occur. EPA
published a revised Public Notification
Rule (PNR) in  2000 (65 FR 25981, May
4, 2000) (USEPA, 2000J). Subsequent
EPA drinking water regulations that
affect public notification requirements
typically include amendments  to the
PNR as a part of the individual
rulemaking. This rule amends the PNR
at § 141.202(a) and § 141.203(a) and
requires Tier 1 notice for detection of a
fecal indicator in a ground water source
sample (see § 141.403) and Tier 2 notice
for treatment technique violations (see
§ 141.404). Also, this rule requires Tier
3 notice for monitoring violations (see
§ 141.403 or § 141.404(b)). In addition,
this rule amends the Consumer
Confidence Report (CCR) (§ 141.153(b)
Appendix A to subpart O) requirements
and includes language to be used when
informing the public of significant
deficiencies and fecal indicator-positive
results in ground water source  samples.
Since the CCR only applies to CWSs, a
special notice requirement for
uncorrected significant deficiencies is
included in the treatment technique
section of this rule for NCWSs. The
language included in this section
parallels language included in the CCR.
Table IV-4 summarizes the GWR
notification requirements.
  The purpose of public notification is
to alert customers of potential risks from
violations of drinking water standards
and to inform them of any steps they
should take to avoid or minimize such
risks. A PWS is required to give public
notice when it fails to comply with
existing drinking water regulations, has
been granted a variance or exemption
from the regulations, or is facing  other
situations posing a potential risk to
public health. Public water systems are
required to provide such notices  to all
persons served by the water system. The
PNR divides the public notice
requirements into three tiers, based on
the seriousness of the violation or
situation.
  Tier 1 is  for violations and situations
with significant potential to have
serious adverse effects on human health
as a result of short-term exposure.
Notice is required within 24 hours of
the violation. Drinking water regulation
Tier 1 notice violation categories and
other situations include, but are not
limited to,  the following:
  • An acute violation of the MCL for
total coliforms when fecal coliform or E.
coli are present in the water distribution
system, or when the water system fails
to analyze the sample for fecal  coliforms
or E. coli when any repeat sample tests
positive for coliform (as specified in
  • Occurrence of waterborne disease
outbreaks, or other waterborne
emergencies; and
  • Other violations or situations with
significant potential to have serious
adverse effects on human health as a
result of short-term exposure, as
determined by the State either in its
regulations or on a case-by-case basis.
The State is explicitly authorized to add
other violations and situations to the
Tier 1 list when necessary to protect
public health where short-termexposure
is a concern.
  Tier 2 is for other violations and
situations with the potential to have
serious adverse effects on human health.
Notice is required within 30 days, with
an extension of up to three months
permitted at the discretion of the State.
Violations requiring a Tier 2 notice
include all  MCL and treatment
technique violations, except where Tier
1 notice is required, and specific
monitoring violations when determined
by the State.
  Tier 3 is for all other violations and
situations requiring a public notice not
included in Tier 1 and Tier 2. Notice is
required  within 12 months of the
violation and may be included in the
Consumer Confidence Report at the
option of the water system. Violations
requiring a Tier 3 notice are principally
monitoring and reporting violations.

1. What Are the Requirements of This
Rule?
  a. GWR violations requiring a Tier 1
notice. A Tier 1 notice is required if a
GWS has a  ground water source sample
collected under § 141.402(a) or
§ 141.402(b) that is positive for one of
the three fecal indicators that are
discussed in Section IV.B and is  not
invalidated by the State.
  b. GWR violations requiring a Tier 2
notice. A Tier 2 notice is required if:
  • A GWS with a significant
deficiency or with fecal contamination
in the ground water source fails to take
corrective action in accordance with the
treatment technique requirements in
§141.403(a);
  • A GWS fails to comply with a State-
approved schedule and plan, including
State-specified interim measures, to
correct a  significant deficiency and/or
eliminate fecal contamination in a
ground water source at any time  after
State approval or State direction
pursuant to § 141.403(a)(2); or
  • A GWS provides 4-log treatment of
viruses but fails to maintain 4-log
treatment, and the GWS does not restore
4-log treatment within four hours.
  c. GWR violations requiring a Tier 3
notice. A Tier 3 public notice is required
for  failure to conduct required ground
water source monitoring, including
source water monitoring when a  system
has a total coliform-positive sample in
the distribution system (§ 141.402(a)(2)),
source water monitoring following a
fecal indicator source water positive
(§ 141.402(a)(3)), and, if required by the
State, assessment source water
monitoring (§ 141.402(b)). Additionally,

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           Federal Register/Vol.  71, No.  216/Wednesday, November  8,  2006/Rules and Regulations    65607
failure to conduct required compliance
monitoring (§ 141.403(b)) requires a Tier
3 public notice.
  d. Special notice informing the public
of significant deficiencies and fecal
indicator-positives in ground water
source samples. In addition to the
public notice requirements of § 141.202,
§ 141.203, and § 141.204, this rule
requires PWSs that use ground water
sources to inform customers of an
uncorrected significant deficiency and
CWSs to inform customers of a fecal
indicator-positive ground water source
sample that is not invalidated by the
State. Under this rule, the GWS must
continue to inform the public annually
until the significant deficiency is
corrected and, in the case of CWSs, the
fecal contamination in the ground water
source is addressed under § 141.403(a).
The State may also direct GWSs to
inform the public of corrected
significant deficiencies.
  The information provided to the
public must include the following (as
applicable to CWSs and NCWSs as
described above): (1) The nature of the
uncorrected significant deficiency or
fecal contamination (for CWSs), if the
source is known, and the date the
significant deficiency was identified by
the State or the date of the fecal
indicator-positive ground water source
sample (for CWSs); (2) for CWSs, if the
fecal contamination in the ground water
source has been addressed under
§ 141.403(a) and the date of elimination;
(3) the State-approved plan  and
schedule for correction including
interim measures, progress to date, and
any interim measures completed, for
any significant deficiency and for CWSs,
fecal contamination in the ground water
source that has not  been addressed
under § 141.403(a); (4) for CWSs, a
description of the potential  health
effects using the health effects language
of § 141.153, Appendix A to subpart O,
if the system receives notice of a fecal
indicator-positive ground water source
sample that is not invalidated by the
State; and (5) if directed by the State,
notification of corrected deficiencies
and how and when they were corrected.
  To satisfy these special notification
requirements, the GWR requires a CWS
to inform the public served by the water
system in the CCR. A NCWS must
inform the public served by the water
system in a manner approved by the
State (e.g., posting in conspicuous
places in the area served by the water
system for a period of time or
distributing information directly to the
public served by the water system)
within 12 months of being notified of a
significant deficiency. Systems must
continue to inform the public annually
until the significant deficiency is
corrected and, in the case of CWSs, fecal
contamination in the ground water
source is addressed in accordance with
§ 141.403(a). If a significant deficiency
is corrected before the next CCR is
issued (for CWSs) or within 12 months
(for non-CWSs), public notification is
not required unless directed by the
State.
                        TABLE IV-4.—SUMMARY OF GWR PUBLIC NOTIFICATION REQUIREMENTS
             Systems must comply with the following
               notification requirements when . . .
                                              Reference
                                                 Tier 1 Public Notification
Triggered source water monitoring sample or assessment source water
  monitoring sample is  positive for E.  coli, enterococci, or coliphage
  (and is not invalidated).
                    §141.402(g).
                                                 Tier 2 Public Notification
A system fails to take corrective action following:
    •  State direction to take corrective action for a fecal  indicator-
      positive sample,
    •  Receipt  of laboratory  notice of fecal indicator-positive ground
      water source sample as a result of triggered source water moni-
      toring under § 141.402(a)(3), or
    •  Receipt  of State written notice of significant deficiency.
A system fails to comply with  a State-approved schedule and plan (in-
  cluding interim measures)  related to correcting a significant defi-
  ciency and/or eliminating fecal contamination  in  a  ground  water
  source.
A system that  elects to  provide such treatment  in  lieu of  triggered
  source water  monitoring fails to maintain  4-log treatment of viruses
  [NOTE: There is no violation  and public  notification required  if the
  system restores 4-log treatment within four hours.].
                    §141.404(d).
                    §141.404(d).
                    §141.404(d).
                                                 Tier 3 Public Notification
A system fails to conduct triggered source water monitoring or assess-
  ment source water monitoring.
A system fails to conduct monitoring to demonstrate compliance with 4-
  log treatment requirement.
                    §141.403(d).

                    §141.403(d).

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65608    Federal  Register/Vol. 71, No. 216/Wednesday, November  8,  2006/Rules and Regulations
                 TABLE  IV-4.—SUMMARY OF GWR PUBLIC  NOTIFICATION REQUIREMENTS—Continued
             Systems must comply with the following
               notification requirements when . . .
                                             Reference
                                            Special Notification Requirements
CWSs:
    System has an uncorrected significant deficiency (or corrected sig-
     nificant deficiency if directed by  the State) or  a source water
     fecal indicator-positive sample. System must repeat notice annu-
     ally until significant deficiency corrected or  fecal contamination
     addressed in accordance with § 141.403(1).
    •  Provide notice as part of CCR.
    •  If significant deficiency is corrected before the next CCR, notifi-
     cation is not required unless directed by the State.
NCWSs:
    System has an uncorrected significant deficiency (or corrected sig-
     nificant deficiency if directed by the State). System must repeat
     notice annually until significant deficiency corrected.
       •  Provide notice in  manner approved by the  State for signifi-
         cant  deficiencies  (e.g.,  posting in conspicuous places  in
         service area or direct  distribution  of information to  public
         served).
       •  If significant deficiency  is corrected within 12 months, noti-
         fication is not required unless directed by the State.
                    Notice must include:
                        —nature of significant deficiency or ground water fecal contamina-
                          tion, and date.
                        —if   the  fecal   contamination  has  been  addressed  under
                          §141.403(a), and date.
                        —State-approved plan and schedule, including interim measures
                          completed (if process ongoing).
                        —required fecal indicator-positive language at:
                           —§141.403(a)(7)(i).
                    Notice must include:
                        —nature of significant deficiency and date.
                        —State-approved plan and schedule, including interim measures
                          completed (if process ongoing).
                        —§141.403(a)(7)(ii).
2. What Is EPA's Rationale for the
Public Notice Requirements?

  EPA believes that to provide adequate
public health protection from fecally
contaminated ground water, the public
must be informed of both existing and
potential significant problems. EPA
recognizes that immediate  public
notification is key to providing effective
communication when there is an
imminent public health risk.  In the
proposed rule, EPA considered
requiring Tier 1 notice for all violations.
The final GWR, however, requires Tier
1 notice only when a ground  water
source sample tests positive for one of
the three fecal indicators that are
discussed in Section IV.B. The presence
of a fecal indicator in a ground water
source sample means that fecal
contamination  is likely to reach
consumers and may have significant
potential for serious adverse health
effects from a short-term exposure.
Other violations of this rule require Tier
2 or Tier 3 notice, depending on the
nature of the violation and potential for
adverse health  effects.
  The Agency believes that it is
important for the public to be informed
when systems are unable to comply
with the GWR requirements that are
established to protect public  health.
EPA's intent is  for the public to be
informed within an appropriate time
frame without unnecessary alarm.
Under the final GWR, the following
treatment technique violations have
been changed from Tier 1 to Tier 2
notice:
  • Failure to correct a significant
deficiency and/or eliminate fecal
contamination in a ground water source;
  • Failure to be in compliance with a
corrective action schedule and plan
within 120 days or to comply with the
plan and schedule after State approval;
and
  • Failure to restore 4-log treatment of
viruses within four hours.
  EPA believes that these violations
require Tier 2 notice because of the
potential for serious adverse health
effects from fecal contamination if
treatment technique requirements are
not met. Failure to conduct ground
water source monitoring  or compliance
monitoring under this rule requires a
Tier  3 notice public notice. EPA
believes that  the public notification
requirements of this rule are protective
of public health by providing timely and
appropriate public notification of
violations and situations that may  affect
public health.
  Public right-to-know was a key tenet
of the 1996 Amendments to the SDWA.
The final GWR requirements allow the
public to become involved in any
decision-making process for corrective
actions taken by the GWS and provide
information for individual health
decisions.
  Consistent with the requirements for
the Consumer Confidence Report (CCR)
to include all detected regulated
contaminants, the special public
information requirements of the GWR
require CWSs to include  information on
any fecal contamination  of its ground
water sources. In addition to addressing
the requirements for CCRs, EPA believes
this notice is important in informing
individual health decisions. Use of the
existing CCR public information process
for CWSs minimizes the burden on
CWSs. EPA believes that the Tier 1
notice requirements for NCWSs are
adequate and appropriate for informing
the public  of fecal contamination of
ground water sources and providing
information for individual health
decisions so no additional notice is
required for fecal contamination at
NCWSs.
  EPA also believes that the public must
be fully informed of uncorrected
significant deficiencies because such
deficiencies may affect their water
supply and pose a health risk. In
addition, EPA believes that this
notification of uncorrected significant
deficiencies will provide an additional
incentive to water systems for rapid
correction  of significant deficiencies. To
minimize the burden on CWS the  final
GWR requires them to use the CCR to
report uncorrected significant
deficiencies. Because the public: served
by NCWSs do not receive CCRs, this
rule requires States to determine the
appropriate method(s) (e.g., posting in
conspicuous places, hand delivery) for
NCWSs to  inform the public of
uncorrected significant deficiencies. In
order to provide the public with
complete information on their water
system, GWSs are required to continue
informing the public of uncorrected
significant deficiencies until corrective
actions are completed.
  Under the Tier 1 public notice
requirements, NCWSs must provide
public notice of a fecal indicator-
positive source water in a form and

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           Federal  Register/Vol.  71, No.  216/Wednesday, November 8, 2006/Rules and Regulations    65609
manner designed to reach transient and
non-transient users of the PWS. This
could include conspicuous posting,
hand delivery or other methods
approved by the State. This notice
would continue until fecal
contamination is corrected.
  EPA believes that there may be
circumstances when the public should
be informed of significant deficiencies
that have been corrected  and that States
are in the best position to make a
decision to require notification of the
public. These circumstances include
significant deficiencies that, although
corrected, presented a public health risk
prior to correction; significant
deficiencies that were uncorrected for
long periods of time; and significant
deficiencies at systems with persistent
significant deficiency issues.
Notification in these circumstances
allows the public served by a PWS to
become involved in any decision-
making processes for management,
operation, and maintenance of the water
system and it also provides information
for individual health decisions.
Notification of corrected significant
deficiencies that had been uncorrected
for long periods provides closure for the
public that has been  notified previously
of the uncorrected significant
deficiency. In addition, notification of
corrected significant deficiencies allows
a community to better evaluate the
management of their system because
they will have complete information on
significant deficiencies at their system.

3. What Were the Key Issues Raised by
Commenters on the Proposed GWR
Public Notification Requirements?
  a.  Treatment technique violations. In
the proposed GWR, EPA considered
Tier 1 notice for the following: (I)
Detection of a fecal indicator-positive  in
a ground water source sample that is not
invalidated by the State; (2) failure to
correct a State-identified  significant
deficiency or source water fecal
contamination within 90 days  or failure
to obtain, within the same 90 days, State
approval of a plan and schedule for
meeting the treatment technique
requirement; and (3)  failure to  perform
source water monitoring. In general,
commenters responded that Tier 1
notice for failure to correct a significant
deficiency within 90 days or in
accordance with the State-approved
time frame is not warranted. Other
commenters stated that only a
confirmed fecal indicator-positive
sample in the source water of a system
that does not provide 4-log treatment of
viruses should require Tier 1 notice. A
few commenters supported EPA's
proposed treatment technique violation
Tier 1 notice. However, most
commenters suggested that Tier 2
notice, rather than Tier 1 notice, is
appropriate for treatment technique
violations.
  EPA agrees that the public health risk
associated with documented fecal
contamination warrants a Tier 1 notice.
EPA agrees that not all failures to
correct a significant deficiency warrant
a Tier 1 notice, since not all significant
deficiencies will result in an imminent
danger to public health. For the specific
case of a failure to correct source water
fecal contamination, the existing Tier 1
notification requirements allow States to
continue to require public notification
for as long as fecal contamination is
present. The final GWR also requires
that CWSs and  NCWSs include notice of
uncorrected significant deficiencies and
that CWSs provide notice of source
water fecal contamination for as long as
significant deficiencies or fecal
contamination remain uncorrected.
CWSs must include this in  the CCR, and
NCWSs will use a form of notification
approved by the State.
  b. Monitoring violations.  Some
commenters responded that failure to
perform any source water monitoring
should not require Tier 1 notice but
rather Tier 2 notice. Other commenters
stated that failure to conduct triggered
source water monitoring should require
a Tier 1 notice,  while failure to conduct
assessment source water monitoring
should require a Tier 2 notice. In
general, commenters believed that
requiring a Tier 1 notice for failure to
collect a source water sample would
unnecessarily alarm the public. Other
commenters supported a Tier 3 notice
for failure to conduct source water
monitoring so that the GWR would be
consistent with other monitoring
violation notification requirements of
§141.204.
  EPA agrees that failure to collect
source water samples or conduct
compliance monitoring may not warrant
a Tier 1 notification since lack of
monitoring data does not indicate there
is an imminent  danger to public health
and such notification could
unnecessarily alarm the public.
Consistent with § 141.204, the final
GWR requires a Tier 3 notice for
violations of the monitoring
requirements, failure to collect ground
water source samples, or failure to
conduct compliance monitoring. EPA
notes that States continue to have the
authority to require a Tier 2 notice  for
monitoring violations if the State
determines that this level of notification
is warranted.
  Some commenters stated that since
the TCR governs the quality of water
provided to a system's customers, it is
inappropriate to require public notice
for failure to conduct source water
sampling under the GWR. EPA disagrees
with the comment and believes that it
is appropriate to establish public
notification requirements for GWSs that
fail to monitor for fecal contamination
in their source water because fecal
contamination can be a significant
health risk. EPA recognizes that the TCR
protects against distribution system
contamination; however, as part of the
GWR risk-targeting strategy, the Agency
believes that source water monitoring is
an integral component in both assessing
potential fecal contamination in the
source water and eliminating this
contamination before it reaches the
distribution systems.
   c. Special notice informing the public
of significant deficiencies or a fecal
indicator-positive ground water sample.
EPA requested comment on practicable
approaches to involve the public in
working with their systems to address
the results of sanitary surveys or
detection of source water fecal
contamination. Some commenters
suggested publishing the results in a
system's CCR, reviewing the results at a
public meeting, or posting the results of
surveys in a public place for NCWSs.
Others supported notifying the public
that the results were available and how
those results could be obtained. Some
commenters noted that significant
deficiencies or source water fecal
contamination would be corrected
rapidly and that involving or informing
the public after the correction might not
be useful.
   EPA believes that adequate
opportunities exist for customers to
obtain  general information on the
sanitary survey of their water supplier
since the complete sanitary survey
report is available from both the State
and the PWS upon request. EPA
believes that the public served by a
GWS should be made aware of
uncorrected significant deficiencies and
source water fecal contamination. The
final GWR uses an existing public
information process, the CCR, to inform
consumers of water from CWSs of
uncorrected significant deficiencies
found during sanitary surveys or of
source water fecal contamination.
NCWSs will use a State approved
process such as continuous posting in
conspicuous places and hand-delivered
notices to inform  consumers of
uncorrected significant deficiencies.
NCWSs will use the State-approved Tier
1 notification process to notify the
public  of fecal source water
contamination. No additional notice of
fecal contamination is required for

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65610   Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations
NCWSs. If directed by the State, GWSs
must also provide notification of
corrected significant deficiencies.

E. What Are the Reporting and
Recordkeeping Requirements for
Systems?

  The GWR establishes new reporting
and recordkeeping requirements for
GWSs that are necessary to ensure that
systems continue to meet the
requirements of the rule and that States
have the information needed to perform
their oversight responsibilities.
  Specifically, the GWR reporting
requirements ensure that States are
aware of any failure to provide an
adequate level of treatment, completed
corrective actions, and system decisions
that triggered source water monitoring is
not necessary based on State  criteria.
  The recordkeeping requirements of
this rule ensure that information is
available to States during sanitary
surveys or other instances to  verify that
systems are complying with the
requirements of this rule for corrective
actions, notice to the public, decisions .
not to conduct triggered source water
monitoring,  and  invalidation of fecal
indicator-positive ground water source
samples.
  This section discusses the new
requirements and the key issues raised
by commenters.

1. Reporting Requirements
  In  addition to the  reporting
requirements of §141.31, a GWS must
provide the following information to the
State (see § 141.405(a)): (1) A GWS
conducting compliance monitoring
must notify the State as soon as
possible, but in no case later than the
end of the next business day, any time
the system fails to meet any State-
specified compliance requirements
including, but not limited to, minimum
residual disinfectant concentration,
membrane operating criteria or
membrane integrity, and alternative
treatment operating  criteria, if operation
in accordance with the criteria or
requirements is not restored within four
hours; (2) a GWS must notify the State
within 30 days after completing any
corrective action for GWSs witb
significant deficiencies or source water
fecal contamination; and (3) if a GWS is
subject to source water monitoring
requirements but is not required to
monitor its source because it determines
using State criteria that a total coliform-
positive samples is related to
distribution systems conditions
pursuant to § 141.402(a)(5)(ii), then the
GWS must provide documentation that
it met the State criteria to the State
within 30 days of the total coliform-
positive sample.

2. Recordkeeping Requirements
  In addition to the reporting
requirements of § 141.31, a GWS must
maintain the following information in
its records (see § 141.405(b)): (1)
Documentation of corrective actions; (2)
documentation of notice to the public of
(a) An unconnected significant
deficiency, or (b) a fecal indicator-
positive ground water source sample
that is not invalidated; (3) records of
decisions where either (a) The State
determines, and documents in writing,
that the cause of a total coliform-
positive sample collected under routine
coliform  sampling is directly related to
the distribution system, or (b) the GWS
determines, according to State criteria,
that the cause of a total coliform-
positive sample collected under routine
coliform  sampling directly relates to the
distribution system; (4) for consecutive
systems,  documentation  of notification
to the wholesale system(s) of total
coliform-positive samples that are not
invalidated; and (5) for systems required
to perform compliance monitoring (a)
Records of the lowest daily residual
disinfectant value and records of the
date and duration of any failure to
maintain the State-prescribed minimum
residual for a period of more than four
hours, and  (b) records of State-specified
compliance requirements for membrane
filtration and of parameters specified by
the State for State-approved alternative
treatment and records of the date and
duration of any failure to meet the
membrane operating, membrane
integrity, or alternative treatment
operating requirements for more than
four hours.
3. What Were the Key Issues Raised by
Commenters on the Proposed GWR
Reporting and Recordkeeping
Requirements for Systems?
  Most commenters agreed with the
system recordkeeping and reporting
requirements in the proposed rule and
that recordkeeping and submittals are
appropriate for systems that disinfect.
Commenters mentioned that these
requirements should be consistent with
those required under other regulations,
such as the TCR or the Stage 1 DBPR.
  EPA agrees that the  recordkeeping
and reporting for systems under this
rule are appropriate and  ensure that
information is available to the State in
performing their oversight
responsibilities. The records must be
available for review during sanitary
surveys and investigations of treatment
technique failures. EPA believes that the
recordkeeping and reporting
requirements for systems under this rule
are consistent with those required under
other regulations.
  Commenters also mentioned that
systems should keep documentation of
how the system operators determined
the proper disinfectant concentration.
EPA notes that this is a recordkeeping
requirement for the State and is required
under this rule.
  Others commenters stated that
recordkeeping requirements in the
proposed rule were unrealistic and
excessive  for extremely small systems
(such as many NCWSs). EPA notes that
many of the recordkeeping requirements
for systems under this rule are
associated with corrective actions and
compliance monitoring, and that only
systems with significant deficiencies,
source water contamination, or source
water treatment would be required to
keep these records. The records must be
available for review during sanitary
surveys and investigations of treatment
technique failures.

F. What Are the Special Primacy,
Reporting, and Recordkeeping
Requirements for States?
  The GWR establishes new special
primacy, reporting, and recordkeeping
requirements for States.
  With regards to special primacy
requirements, 40 CFR part 142, National
Primary Drinking Water Regulations
Implementation, 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, 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 an application for
approval of their program revision.
  The special primacy conditions of this
rule  (§ 142.16(o)) ensure (1) That States
have the legal authority to require
correction of significant deficiencies
and/or source water fecal
contamination, as well as the authority
to require source water monitoring, (2)
that States adopt and implement
adequate procedures for sanitary
surveys, and that (3)  States develop
criteria for source water monitoring and
treatment technique requirements.
  With regards to reporting and
recordkeeping, the SDWA establishes
requirements that a State or eligible
Indian Tribe must meet to assume and
maintain primacy for its PWSs. Among
others, these requirements include

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           Federal  Register/Vol.  71,  No. 216/Wednesday, November 8, 2006/Rules and Regulations    65611
keeping records and making reports
available on activities that EPA requires
by regulation.
  The reporting requirements of this
rule ensure that EPA is notified when
the most recent sanitary survey was
completed, the date a system completed
corrective action, and of systems
providing at least 4-log treatment of
viruses.
  The recordkeeping requirements of
this rule ensure that States maintain
various records to determine
compliance with this rule.
  This section discusses these new
requirements and the key issues raised
by commenters on these requirements.

1. Primacy Requirements
  The SDWA established requirements
that a State or eligible Indian Tribe must
meet to assume and maintain primary
enforcement responsibility (i.e.,
primacy).  These requirements include
the following:
  •  Adopting drinking water
regulations that are no less stringent
than Federal drinking water  regulations;
  •  Adopting and implementing
adequate procedures for enforcement;
  •  Keeping records on EPA-regulated
activities and making records available;
  •  Issuing variances and exemptions
(if allowed by the State) under
conditions no less stringent than
allowed under the SDWA; and
  •  Adopting and being capable of
implementing an  adequate plan for the
provision  of safe drinking water under
emergency situations.
  To implement this rule, the State is
required to adopt the following
revisions to 40 CFR part 141:
  •  §141.21—Coliform sampling.
  •  § 141.28—Certified laboratories.
  •  § 141.153—Content of the  reports.
  • §141.202—Tier 1 Public Notice-
Form, manner, and frequency of notice.
  •  §141.203—Tier 2 Public Notice-
Form, manner, and frequency of notice.
  • § 141.204—Tier 3 Public Notice-
Form, manner, and frequency of notice.
  • Subpart O—Regulated
contaminants.
  • Subpart Q—Public Notification of
Drinking Water Violations, Appendix A,
NPDWR Violations and Other Situations
Requiring Public Notice.
  • Subpart Q—Public Notification of
Drinking Water Violations, Appendix B,
Standard Health Effects Language for
Public Notification.
  • Subpart Q—Public Notification of
Drinking Water Violations, Appendix C,
List of Acronyms  Used in Public
Notification Regulation.
  • Subpart S—Ground Water Rule.
  In addition to adopting the basic
primacy requirements specified in 40
CFR part 142, States are required to
address special primacy conditions
pertaining to specific requirements
where implementation of the rule
involves activities beyond general
primacy provisions. The State must
include these regulation-specific
provisions in an application for
approval of their program revision.
Under this rule, the special primacy
conditions are in the following four
categories: Legal Authority, Sanitary
Surveys, Source Water Microbial
Monitoring, and Treatment Technique
Requirements.
  The application for approval of a State
program revision that will adopt 40 CFR
part 141, subpart S, must contain a
description of how the State will
accomplish these four program
requirements.
  a. Legal authority. The application for
primacy must demonstrate that the State
has: (i) The authority contained in
statute or regulation to ensure that
GWSs take the appropriate corrective
actions, including interim measures, if
necessary, needed to address significant
deficiencies; (ii) the authority contained
in statute or regulation to ensure that
GWSs conduct source water monitoring;
(iii) the authority contained in statute or
regulation to ensure that GWSs take the
appropriate corrective actions,
including interim measures, if
necessary, to address any source water
fecal contamination identified during
source water monitoring; and (iv) the
authority contained in statute or
regulation to ensure that GWSs consult
with the State regarding corrective
action(s).
  b. State practices or procedures for
sanitary surveys. In addition to the
general requirements for sanitary
surveys, a primacy application must
describe how the State will implement
a sanitary  survey program and include
an evaluation of the following eight
sanitary survey components: source;
treatment; distribution system; finished
water storage; pumps, pump facilities,
and controls; monitoring, reporting, and
data verification; system management
and operation; and operator compliance
with State requirements.
  The State must conduct sanitary
surveys that address the eight sanitary
survey components no less frequently
than every three years for CWSs and
every five  years for NCWS.
  The State may conduct sanitary
surveys once every five years for CWSs
if the system  meets performance criteria
(see Section IV.A.I). In its primacy
application, the State must describe
how it will determine whether a CWS
has an outstanding performance record.
  The State must define and describe in
its primacy application at least one
specific significant deficiency in each of
the eight sanitary survey elements.
  As a condition of primacy, the State
must provide GWSs with written notice
describing any significant deficiencies
no later than 30 days after the State
identifies the significant  deficiency. The
notice may specify corrective actions
and deadlines for completion of
corrective actions.
  c. State practices or procedures for
source water microbial monitoring. The
State's primacy application must
include a description of the following:
(i) The criteria the State will use for
extending the 24-hour time limit for a
system to collect a ground water source
sample to comply with the source water
monitoring requirements; (ii) the criteria
the State or GWS will use to determine
that the cause of a total coliform-
positive sample is directly related to the
distribution system; (iii) the criteria the
State will use for determining whether
to invalidate a fecal indicator-positive
ground water source sample; and (iv)
the criteria the State will use to  allow
systems to conduct source water
microbial monitoring at a location after
treatment.
  d. State practices or procedures for
treatment technique requirements. As a
condition of primacy, the State must
verify within 30 days after the GWS has
reported to the State that it has
completed corrective action that
significant deficiencies or source water
fecal contamination have been
addressed either through written
confirmation from GWSs or a site visit
by the State. A GWS's written notice
may serve as this verification. The
State's primacy application must
include the following: (i) Notification
methods that the States will require
NCWSs to use to inform the public of
uncorrected significant deficiencies; (ii)
the process the State will use to confirm
that a GWS achieves at least a 4-log
treatment of viruses; (iii)  the process the
State will use to determine the
minimum residual disinfectant
concentration; (iv) the State-approved
alternative technologies to achieve at
least 4-log treatment of viruses; (v) the
monitoring and compliance
requirements the State will require for
GWSs treating to at least 4-log treatment
of viruses; (vi) the monitoring,
compliance and membrane integrity
testing requirements the State will
require to demonstrate virus removal for
GWSs using membrane filtration
technologies; and (vii) the criteria,
including public health-based
considerations and incorporating on-site
investigations and source water

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65612   Federal Register/Vol. 71, No.  216/Wednesday,  November 8, 2006/Rules and  Regulations
monitoring results, the State will use to
determine if a GWS may discontinue
4-log treatment of viruses.

2. Reporting Requirements
  States are required to report
violations, variance and exemption
status, and enforcement actions to EPA
according to the provisions of § 142.15.
The final GWR adds the following three
reporting requirements to these
provisions (§142.15(c)(7)): (i) The
month and year in which the most
recent sanitary survey was completed,
or for a State that uses a phased review
process, the date that the last element of
the applicable eight elements was
evaluated for each GWS, (ii) the date the
GWS completed corrective action, and
(iii) all GWSs providing at  least 4-log
treatment of viruses for a ground water
source.

3. Recordkeeping Requirements
  The regulation at § 142.14 requires
States with primacy to keep various
records. This rule requires  States to
keep the following additional records:
(i) Records of written notices of
significant deficiencies; (ii) Records of
corrective action plans, schedule
approvals, and State-specified interim
measures; (iii) Records of confirmations
that a significant deficiency has been
corrected and/or the fecal
contamination in the ground water
source has been addressed; (iv) Records
of State determinations and records of
ground water system's documentation
for not conducting triggered source
water monitoring; (v) Records of
invalidations of fecal indicator-positive
ground water source samples; (vi)
Records of State approvals of source
water monitoring plans; (vii) Records of
notices of the minimum residual
disinfection concentrations (when using
chemical disinfection) needed to
achieve  at least 4-log virus inactivation
before or at the first customer; (viii)
Records of notices of the State-specified
monitoring and compliance
requirements (when using  membrane
filtration or alternative treatment)
needed to achieve at least 4-log
treatment of viruses (using inactivation,
removal, or a State-approved
combination of 4-log inactivation and
removal) before or at the first customer;
(ix) Records of written notices from the
GWS that it provides at least 4-log
treatment of viruses (using inactivation,
removal, or a State-approved
combination of 4-log virus inactivation
and removal) before or at the first
customer for each ground water source;
and (x) Records of written
determinations that the GWS may
discontinue 4-log  treatment of viruses
(using inactivation, removal, or a State-
approved combination of 4-log
inactivation and removal).

4. What Were the Key Issues Raised by
Commenters on the Proposed GWR
Special Primacy, Reporting, and
Recordkeeping Requirements for States?
  Many commenters responded to this
request for comment and generally
indicated that the requirements sbould
be simplified and that a greater level of
flexibility be afforded to the States.
  Commenters questioned why the
States need to identify their approach
and rationale for determining the fecal
indicators to be used and commented
that States,  at their discretion, should be
able to use any EPA-approved method.
Commenters also felt that States should
have the latitude to allow different
indicators if changes in technologies or
laboratory resources prompt an
amendment. EPA agrees with these
comments,  and this rule does not
include a requirement regarding
selection of a fecal indicator.
  Some commenters believe that the
GWR should provide specific
information on how GWSs can achieve
4-log removal of viruses and how States
should evaluate treatment techniques to
assure compliance with the rule. In
particular, the commenters wanted more
information and guidance on how States
and GWSs would determine what
disinfectant residual level or operational
parameters (in the case of membrane
filtration or alternative treatment
technologies, such as UV) GWSs would
have to maintain to ensure that the GWS
is achieving 4-log treatment of viruses.
The commenters indicated that
describing in their primacy package the
approach they will use in determining
which specific treatment option is
appropriate in a given circumstance will
be an arduous task.
  EPA recognizes that selection and
approval of a treatment technique
option is system-specific. This rule does
not require States to describe in their
primacy package the approach they will
use in determining which specific
treatment option is appropriate in a
given circumstance. This rule does
require the  States to describe any State-
approved alternative technologies that
GWSs may  use to meet the treatment
technique requirements. With regard to
specific treatment techniques, EPA has
recently issued the Membrane Filtration
Guidance Manual (USEPA, 2005a) and
is developing an ultraviolet  disinfection
guidance manual. EPA intends to
develop a GWR Corrective Action
guidance for further information
regarding corrective actions and
treatment techniques for GWSs.
  Commenters indicated that a State
should not have to describe "how it will
consult" with water suppliers regarding
treatment requirements. EPA believes
that the process requiring PWS
consultation with the State prior to
implementing corrective action is
important in ensuring that appropriate
corrections occur. EPA recognizes that
States have a long history of consulting
with water systems, so the Agency
removed this provision from the special
primacy requirements in this rule.
Instead, the GWR requires that States
identify the authority that they have to
ensure consultation, which ensures that
corrective actions occur, as necessary.

G. Variances and Exemptions
  Section  1415  of the SDWA allows
States to grant variances from NPDWRs
under certain conditions; section 1416
establishes the conditions under which
States may grant exemptions to MCL or
treatment technique requirements.
These conditions and EPA's view on
their applicability to the GWR are
summarized as follows:

1. Variances
  Section  1415  of the SDWA specifies
two provisions under which general
variances to treatment technique
requirements may be granted:
  (1) A State that has primacy may grant
a variance to a PWS from any
requirement to use a specified treatment
technique for a contaminant if the PWS
demonstrates to the satisfaction  of the
State that the treatment technique is not
necessary to protect public health
because of the nature of the PWS's raw
water source. EPA may prescribe
monitoring and other requirements as
conditions of the variance (section
  (2) EPA may grant a variance from any
treatment tecbnique requirement upon a
showing by any person that an
alternative treatment technique not
included in such requirement is at least
as efficient in lowering the level of the
contaminant (section 1415(a)(3)).
  EPA does not believe that the variance
provision under the SDWA at
1415(a)(l)(B) is applicable to GWSs
under this rule. As discussed above, the
regulation employs a targeted approach
whereby corrective action is required
only for those systems that have the
most risk " those systems that have
found fecal contamination in their
source water as indicated by source
water monitoring, or have been found to
be susceptible to contamination as
indicated by a significant deficiency
from a sanitary survey. Thus, the
treatment technique requirements
account for the nature of the PWS raw

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           Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations
                                                                     65613
water source. The GWR does not require
the use of disinfection, nor does it
compel the system to address the raw
water source if, for example, an
alternate source of drinking water is
available.
  With respect to the variances
authorized under 1415(a)(3), EPA notes
that this provision  is unlikely to be used
because the four treatment techniques
provided in the GWR cover  a broad
range of options and States can approve
any alternative treatment technologies.
Given this broad range of treatment
technique options, it is unlikely that a
system could demonstrate to EPA that
an alternative treatment technique not
included in the regulation is at least as
efficient in lowering the level of the
contaminant of concern.
  Section 1415(e) of the SDWA
describes small PWS variances, but
these cannot be granted for a treatment
technique for a microbial contaminant.
Hence, small PWS  variances are not
allowed for the GWR.

2. Exemptions
  Under SDWA section 1416(a), a State
may exempt any PWS from a treatment
technique requirement upon a finding
that (1) due to compelling factors
(which may include economic  factors
such as qualification of the PWS as
serving a disadvantaged community),
the PWS is unable to comply with the
requirement or implement measures to
develop an alternative source of water
supply; (2) the PWS was in operation on
the effective date of the treatment
technique requirement, or for a PWS
that was not in operation by that date,
no reasonable alternative source of
drinking water is available to the new
PWS; (3) the exemption will not result
in an unreasonable risk to health; and
(4) management or restructuring
changes (or both) cannot reasonably
result in compliance with the Act or
improve the quality of drinking water.
  EPA believes that granting an
exemption to the treatment
requirements of the GWR would result
in an unreasonable risk to health. As
described in section III.C, microbial
contamination causes acute  health
effects, which may be severe in sensitive
subpopulations. Moreover, the
additional treatment requirements of the
GWR are targeted to PWSs with the
highest degree of risk. Due to these
factors, EPA does not support the
granting exemptions from the GWR.

V. Explanation of Extent of GWR

A. Mixed Systems
  This rule applies to PWSs (CWSs and
NCWSs) that use ground water  in whole
or in part (except GWUDI systems),
unless all ground water is commingled
with surface water before treatment at
the surface water treatment plant is
applied, in which case surface water
treatment regulations apply. This means
that the treatment technique
requirements of the GWR for significant
deficiencies apply  to any system using
both ground water and surface water
that has a significant deficiency
identified past the  point of surface water
treatment, unless the State determines
that the significant deficiency is in a
portion of the system served solely by
surface water. EPA believes that the
same level of public health protection
provided by this rule to persons served
solely by ground water must be
provided to persons served by ground
water supplies in mixed systems.
  EPA received comments regarding the
applicability of the proposed GWR to
systems that serve both ground water
and surface water. Commenters noted
that the requirements for these "mixed
systems" were not  explicit for the
individual rule components such as
sanitary surveys and triggered source
water monitoring. For example,
commenters specifically noted that the
proposed GWR did not address how to
conduct the triggered source water
monitoring requirement after a total
coliform-positive under the TCR was
detected in systems where  ground water
and surface water are blended in the
distribution system.
  EPA has included more explicit
regulatory language that describes how
"mixed systems" must comply with
individual components of this rule to
assist PWSs in understanding and
implementing the GWR provisions.
There are approximately 3,700 mixed
systems in the U.S. This rule explicitly
addresses general applicability and the
applicability of specific GWR
components to mixed systems. The
complexity and variety of configurations
and operations in these mixed systems
do not  allow for all the possible
scenarios to be addressed within a
regulatory framework, so States will
have the discretion to make a site-
specific determination whether a
significant deficiency is in  a portion of
the system served solely by surface
water.
  EPA will provide further information
through implementation guidance and
other non-regulatory approaches to
assist States and water systems in
meeting the intent of this rule, to target
GWSs that are at risk of fecal
contamination and to require these
systems to take corrective action to
protect public health. In some cases, it
may be possible to  identify customers or
portions of the distribution system in
mixed systems served solely by surface
water or ground water. In other cases, it
may not be possible or may be transitory
due to complex and/or variable system
hydraulic conditions.

B. Cross-Connection Control
  EPA is concerned about fecal
contamination entering distribution
systems; however, cross-connection
control requirements are not a part of
this rule, though the proposal contained
cross-connection consideration. The
Stage 2 Microbial and Disinfection
Byproducts Federal Advisory
Committee's Agreement in Principle (65
FR 83015, December 2000) (USEPA,
2000b) states that cross-connections and
backflow in distribution systems
represent a significant public health risk
and that EPA should initiate a process
to address cross-connection control and
backflow prevention requirements as
part of the six-year review of the TCR.
EPA has published its intent to consider
such requirements as part of the
revisions to the TCR (67 FR 19030, April
17, 2002) (USEPA, 2002b).
VI. Implementation
  This section describes the regulations
and other procedures and policies that
States must adopt, as well as the
requirements that public GWSs would
have to meet to implement this rule.
Also discussed are the compliance
deadlines for these requirements.
  States must continue to meet all other
conditions of primacy at 40 CFR part
142. Section 1413(a)(l) of the 1996
SDWA Amendments provides two years
(plus more time if the Region approves)
after promulgation of the final GWR for
the State to adopt drinking water
regulations that are no less stringent
than the final GWR in order to obtain
primacy for the GWR.
  GWSs must continue to meet all other
applicable requirements of 40 CFR part
141. The SDWA as amended  in 1996
(see section 1412(b)(10)) provides three
years after promulgation for compliance
with new regulatory requirements.
Accordingly, the GWR requirements
that apply to the PWS directly,
specifically the requirements found
under subpart S of 40 CFR part 141
(source water monitoring, corrective
actions and treatment technique
requirements, compliance monitoring,
recordkeeping and reporting, and public
notice and public information), take
effect three years after promulgation.
The State may, in the case of an
individual system, provide additional
time of up to two years for capital
improvements, if necessary, in
accordance with the statute.

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65614   Federal Register/Vol. 71, No.  216/Wednesday,  November 8, 2006/Rules and  Regulations
  This rule includes conditions of
primacy at 40 CFR part 142 under
which States will have until December
31, 2012 to complete the initial sanitary
survey cycle for CWSs, except those
meet performance criteria, and until
December 31, 2014 to complete the
initial sanitary survey cycle for all
NCWSs and  CWSs that meet
performance criteria (refer to Section
IV.A.I for criteria). These sanitary
survey implementation deadlines
provide time for  States to adopt the rule
and obtain primacy (two to four years
allowed by the SDWA at 1413(a)(l)). In
addition, systems are given three years
to comply with drinking water
regulations by the SDWA at
(1412(b)(10)). Finally,  States need three
to five years to complete the first cycle
of sanitary surveys because there are
many GWSs and States have limited
resources.
  The GWR places the same sanitary
survey frequency requirements on
GWSs as is currently required of surface
water systems under 40 CFR part 141
subpart H.
  GWSs must comply with all
applicable requirements beginning
December 1, 2009 unless otherwise
noted.
VII. Economic Analysis (Health Risk
Reduction and Cost Analysis)
  This section summarizes the Health
Risk Reduction and Cost Analysis
(HRRCA) in support of the final GWR.
This analysis has been revised and
updated from the HRRCA prepared for
the proposal as required by section
1412(b)(3)(C) of the SDWA. In addition,
under Executive  Order 12866,
Regulatory Planning and Review, EPA
must estimate the costs and benefits of
this rule in an Economic Analysis (EA).
EPA has prepared an EA (USEPA,
2006d) to comply with the requirements
of this order and to update the SDWA
HRRCA. The EA document for the GWR
is available in the docket and is also
published on the government's Web site
http://www.regulations.gov.
  The HRRCA consists of seven
elements as follows: (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 alternatives; (5) effects of the
contaminant on the general population
and sensitive subpopulations including
infants, children, pregnant women,
elderly, and immunocompromised; (6)
increased health risks  that  may occur as
a result of compliance; and (7) other
relevant factors such as uncertainties in
the analysis. A summary of these
elements is provided in this section of
the preamble, and a complete
discussion can be found in the GWR EA
(USEPA, 2006d).
  Both the benefits and the costs
discussed in this section are presented
as annualized present  values in 2003
dollars. This process allows comparison
of cost and benefit streams that are
variable over a given time period and
differs from the GWR proposal (USEPA,
2000a), which only used an annual
estimate. The time frame used for both
benefit and cost comparisons in this
rule is 25 years. This time interval
accounts for early rule implementation
activities (e.g., States adopting the
criteria of the regulation) and the time
for different types of compliance actions
to be realized up through year 25
following rule promulgation (e.g.,
identification and correction of sanitary
survey deficiencies, identification of
wells that are fecally contaminated and
subsequent corrective  action). The
Agency 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.
The GWR EA (USEPA, 2006d) also
shows the undiscounted stream of both
benefits and costs over the 25 year time
frame.
  The quantified benefits are calculated
based only on endemic, acute disease
illness, and death from some viral, but
not bacterial, contamination of PWS
wells. EPA was able to monetize only
this subset of total benefits which were
compared to the total costs of this rule.
The total benefits, both quantified and
nonquantified, are estimated using
illness and death data as well as non-
health benefits such as avoided costs
(e.g., restaurant closures) due to
outbreaks. Furthermore, the total health
benefits are estimated based on a full
range of health effects, including acute
and chronic illness and endemic and
epidemic disease from both bacteria and
virus contamination. EPA believes that
the quantified benefits for this rule
underestimate reduction in risk because
the Agency was only able to calculate a
subset of the total benefits; peer
reviewers of the GWR benefit analysis
agree that the quantified benefits are
biased low. The costs of the rule stem
mostly from the sanitary survey and the
correction of significant deficiencies as
well as the triggered source water
monitoring and corrective action
provisions described earlier in  this
preamble.
  This section of the preamble  includes
12 elements as follows: (A) Rationale for
choosing a different alternative from the
proposed alternative, (B) occurrence arid
risk analyses that support this rule, (C)
both quantified and nonquantified
benefits,  (D) both quantified and
nonquantified costs. (E) potential
impact on households, (F) incremental
costs and benefits, (G) benefits  from
simultaneous reduction of co-occurring
contaminants, (H) increases in risk due
to other contaminants, (I) effects on the
general population and special
subgroups, (J) uncertainties in risk,
benefit, and cost estimates, (K)  benefit/
cost determination, and (L) major
comments and responses. Section VII.F
presents the benefits and costs  for the
four regulatory alternatives that were
considered in this rule. Table VII-1
provides a summary of monetized
benefits and costs for each GWR
regulatory alternative.
               TABLE VII-1.—MONETIZED BENEFITS AND COSTS FOR GWR REGULATORY ALTERNATIVES
                                                   [Millions, 2003$]
Rule alternative
3% Discount rate
Mean
5th-95th
Percentiles
7% Discount rate
Mean
5th-95th
Percentiles
                                                National GWR Benefits
Enhanced COI:
Risk-Targeted Approach
Sanitary Survey . 	
Multi-barrier Accroach 	
$197
36
21.3
$6 5-$45 4
0.9-9.3
7.1-48.7
$16 8
2 9
18.2
$5 5-$38 6
07-75
6.0-41 .6

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           Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and  Regulations    65615

         TABLE VI1-1 .—MONETIZED BENEFITS AND COSTS FOR GWR REGULATORY ALTERNATIVES—Continued
                                                   [Millions, 2003$]
Rule alternative
Across the Board Disinfection
Traditional COI:
Risk-Targeted Approach
Sanitary Survey . .. ... 	
Multi-barrier Approach .. . 	 	
Across the Board Disinfection

3% Discount rate
Mean
70.2
10.0
1.9
10.8
35.5
5th-95th
Percentiles
18.3-177.0
2.2-27.0
0.3-5.5
2.5-28.9
6.5-102.4
7% Discount rate
Mean
61.9
8.6
1.5
9.3
31.5
5th-95th
Percentiles
16.1-156.3
1.9-22.9
0.2-4.5
2.1-24.8
5.7-90.8
                                                 National GWR Costs
Risk-Targeted Approach 	
Sanitary Survey .. 	
Multi-barrier Approach 	 	
Across the Board Disinfection

61.8
15.3
67.9
6864

45.2-81 .4
11.8-19.2
49.4-89.5
636 8-735 4

62.3
15.3
69.4
6653

46 1-81.6
11.9-19.0
51 .0-90.6
6123-7170

A. How Has the Final Rule Alternative
Changed From the Proposed Rule
Alternative?
  The primary elements of the GWR
alternative that EPA proposed were
sanitary surveys, triggered source water
monitoring, hydrogeologic sensitivity
analyses (HSAs), routine monitoring,
corrective action, and compliance
monitoring. This alternative was termed
"multi-barrier approach." After the
proposal, EPA considered comments
received as discussed in section II.C of
this preamble. This review resulted in
the Agency choosing a different  final
rule alternative, Alternative 2, or the
"risk-targeted approach." EPA believes
that the final rule is a logical outgrowth
of the proposed rule, that it is supported
by comments, and that it provides
public health benefits while
apportioning costs in a more flexible
targeted manner.
  EPA continues to believe that the
elements of the multi-barrier approach
are important. At first, EPA attempted to
redesign the multi-barrier approach to
resolve the issues raised by commenters.
In this redesigned structure, HSAs were
optional and routine monitoring
(renamed assessment source water
monitoring) was a required up-front
monitoring program limited to 1 year of
monthly samples. EPA has estimated
the costs and benefits for this variation
of the multi-barrier approach in the final
EA (Alternative 3). However, EPA
ultimately determined that the structure
of this variation of the multi-barrier
approach was too restrictive to achieve
the full potential benefits of an
assessment source water monitoring
program. In addition, it did not provide
sufficient flexibility to States, which
was a major theme of the comments
EPA received. Therefore, EPA decided
to redesign the source water monitoring
provision by making assessment source
water monitoring an option that States
can require as they see fit. The purpose
of this optional requirement is to target
source water monitoring to systems that
the States believe are at a higher risk for
microbial contamination. EPA believes
that States are in the best position to
assess which  systems would most
benefit from a comprehensive source
water monitoring program. EPA
recommends that States use HSAs as
one tool to identify high risk systems for
assessment source water monitoring.
The risk-targeted approach of  the final
rule contains  sanitary surveys, triggered
source water monitoring, optional
assessment source water monitoring,
corrective action, and compliance
monitoring.
  For the Economic Analysis of the final
rule alternative, EPA did not include
potential costs and benefits of
assessment source water monitoring.
This is because assessment source water
monitoring is an optional requirement
under the final GWR. Thus, the EA
considers quantified costs and benefits
only of sanitary surveys, triggered
source water monitoring, corrective
action, and compliance monitoring.
Throughout the EA, the final rule
alternative is listed as Alternative 2—
the risk-targeted approach. A discussion
of the costs and benefits for the
regulatory alternatives considered may
be found in Chapter 8 of the EA
(USEPA, 2006d).

B. Analyses That Support This Rule

  EPA estimates national viral and fecal
indicator occurrence based on data from
several studies. The following
discussion summarizes EPA's
occurrence and risk analyses that
support this rule.
1. Occurrence Analysis
   a. Study selection. As discussed in
Section III.C.3 of this preamble and in
the NODA, EPA examined data from 24
studies of pathogen and fecal indicator
occurrence in ground water wells that
supply PWSs (USEPA, 2006e). EPA
selected 15 of these studies to use in the
risk assessment analysis to estimate
national viral and fecal indicator
occurrence in ground water. The
Occurrence and Monitoring Document
for the Final Ground Water Rule
(USEPA, 2006b) provides a detailed
discussion of each occurrence study
evaluated.
  To assist study selection and
occurrence modeling, EPA convened a
two-day statistical workshop in May
2005. The core workgroup included
expert participants from several
government agencies and private
consulting firms working  as U.S.
government advisors. A summary of the
workgroup proceedings, including a list
of all participants, is included in the
final docket for  this rulemaking. The
charge to the workgroup was to consider
how to improve modeling of viral and
indicator occurrence. The statisticians
strongly recommended that EPA make
use of all the available data unless there
were known quality assurance problems
with a data set or the well
contamination scenario was outside the
normal operating range of U.S. PWS
wells.
  After the workshop, EPA followed
through on the workgroup's
recommendations and used all available
data sets having enterovirus and fecal
indicator occurrence in ground water
source(s) from PWS wells in the United
States with some exceptions. Of the 16
studies described in the proposed GWR,
EPA did not use data from five studies
to inform the national occurrence

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65616   Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations
estimates for this rule. EPA did not use
the data set of alluvial wells from
Missouri that were substantially affected
by severe Mississippi River flooding
(Vaughn, 1996). Data from a California
study (Yates ef al., 1999) were deleted
from further consideration because data
were available only by well and not by
sample, so the probability of viruses
detected by individual assays could not
be assessed.  Data from the Whittier,
California study (Yanko et al., 1999)
were not used because the study author,
in comment  on the proposal, suggested
that the observed somatic coliphage
occurrence was not due to fecal
contamination. EPA did not use data
from Honolulu, Hawaii (Fujioka and
Yoneyama, 2001) because the wells
were not sampled for pathogenic viruses
and because E. coli are endemic in
tropical ecosystems and not simply
indicators of fecal origin.  EPA did not
use data from the U.S.-Mexico Border
study because the human virus data
were never reported in written form.
  Of the seven studies that became
available since proposal and described
in the NODA, EPA did not use four
studies to inform national occurrence
estimates. EPA did not use the data from
the set of wells developed by Karim et
al. (2003; 2004), because these 20 wells
are also included in Abbaszadegan ef al
(2003). EPA  did not have  sufficient
information  to distinguish which of the
20 wells from Karim (2003; 2004) were
the same wells from Abbaszadegan et al.
(2003) and, therefore, only used the
larger data set. EPA did not use the
National Field Study data (USEPA,
2006f) because the data set includes
both PWS and domestic wells, and
insufficient information is available to
identify which wells are PWS wells.
Also, the National Field Study data set
(USEPA, 2006f) included virus cell
culture measurements using smaller
sample volumes than all of the other
data sets. EPA did not use data from La
Crosse, Wisconsin (Borchardt ef al.,
2004) because this was a small study of
four wells (and two other wells sampled
once only) in one  locality which,
although not regulated as GWUDI, were
under investigation to determine if that
regulatory determination  was correct.
EPA did not use data from another small
study of two wells in Missoula,
Montana because of the size of the data
set. In addition, EPA added one study
of 38 wells from Helena, Montana that
was submitted to EPA in response to the
NODA.
  b. Description of occurrence data used
to characterize national viral and
indicator occurrence. Table VII-2 shows
the 15 studies used to inform national
occurrence estimates for viruses and
indicators. One data set (Lieberman et
al., 2002), targeted wells based on
presence of total coliforms and other
indicators of vulnerability to fecal
contamination. Another data set
(Abbaszadegan ef al., 2003), targeted a
representation of wells throughout the
United States based on hydrogeological
conditions, but excluded any wells that
were poorly constructed, ground water
under the direct influence of surface
water (GWUDI), or without well logs.
Other studies sampled a subset of wells
in a particular State, region, or
hydrogeological setting. Most of the
studies were designed to capture subsets
of the total PWS well population. EPA
excluded data from wells that States had
identified as being GWUDI. Only  a
couple of the studies included such
wells in their sample set (Lieberman et
al., 2002, Atherholt ef al., 2003). PWS
using wells with GWUDI are required to
meet the same treatment technique
requirements for pathogens that pertain
surface water supplies and are not
subject to the requirements of this rule.
EPA's analysis to develop national
estimates for virus and indicator
frequency of occurrence in wells made
no attempt to weight any of the studies
to compensate for any perceived over-
or under-representation of the subset as
compared with the total population.

TABLE VII-2.—LIST OF STUDIES USED
 IN NATIONAL OCCURRENCE ANALYSIS

Lieberman et al,, 2002 (multiple States).
Abbaszadegan, et al., 2003 (multiple States).
Lindsey et al., 2002 (Pennsylvania Non-com-
  munity Wells).
Francy et al., 2004 (Southeast Michigan).
Atherholt et al., 2003 (New Jersey).
Davis and Witt, 2000 (Missouri Ozark Pla-
  teau #1).
Femmer, 2000 (Missouri Ozark  Plateau #2).
USEPA  et al.,  1998d (Wisconsin  Migrant
  Worker Camp).
Doherty, 1998 (New England).
Battigelli,  1999  (Three-State  Study:  Wis-
  consin).
Banks et al., 2001 (Three-State Study: Mary-
  land).
Banks  and   Battigelli,   2002  (Three-State
  Study: Maryland).
Minnesota DOH, 2000 (Three-State  Study:
  Minnesota).
USEPA, 1998a (EPA Vulnerability Study).
Miller and Meek, 2006 (Montana).

  Using enterovirus cell culture and E.
coli data from the 15  studies, EPA
modeled virus and fecal indicator (E.
coli) occurrence in ground water. EPA
believes that enterovirus cell culture
measurements provide the best available
basis for estimating pathogenic viral
occurrence since it captures viruses that
are alive and infectious. However,
because the  cell culture procedure only
captures a portion of the types of
pathogenic viruses that may actually
occur in well water, use of this metric
underestimates total viral occurrence.
EPA did not use PWS samples assayed
using PCR methods to estimate national
viral occurrence for this rule because
PCR methods cannot discriminate
between infectious and non-infectious
viruses. Three of the 15 studies
included viral concentration data
(Lieberman ef al., 2002, Abbaszadegan,
ef al., 2003 and Lindsey ef al., 2002).
EPA used data from these studies to
inform national estimates for viral
concentrations among wells modeled to
have viral occurrence. However, since
the sampling sites from Lieberman ef
ay., 2002 were selected because they had
a history of total coliform contamination
or other evidence of vulnerability
(whereas the sample sites from the other
two studies had no such site selection
bias), EPA only used viral concentration
data from Lieberman ef al.,  2002 for a
small portion of wells in the U.S.
  EPA used data on the indicator E. coli
to inform estimates of fecal
contamination occurrence. Indicator
data is important because illness can
result from consuming ground water
with fecal contamination in the absence
of identified viruses. EPA chose to use
E. coli as the indicator organism to
inform national fecal contamination
occurrence for several reasons. First,
analysis using two or more  indicator
organisms becomes increasingly
complex. Second, substantial variability
among studies in choice of indicators,
indicator assay method, sample volumes
and, in the case of coliphage, bacterial
host and host range, adds uncertainty
when data sets are  combined. Third, for
any one indicator other than E. coli, the
number of assays with consistency of
measurement is small. Fourth and most
important, EPA believes that E. coli will
be the most likely fecal indicator used
when PWS implement the GWR and
therefore national estimates of E. coli
occurrence can be used to inform
potential cost implications for
implementing the GWR.
  c. How data were used to estimate
national occurrence of viral and fecal
contamination. Data from each of 15
studies were combined into one single
data set used to determine the
probabilities of wells having anytime
viral (indicated by  enterovirus cell
culture) or fecal indicator (indicated by
E. coli) contamination. The results of
this effort led naturally to a combined
analysis, which also modeled co-
occurrence of viruses and E. coli. This
combined model serves as the basis of
EPA's national quantitative occurrence
estimates.

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           Federal  Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations    65617
  EPA's occurrence model includes four
categories of wells:
  • Wells with no E. coli occurrence,
but some virus occurrence,
  • Wells with both E. coli and virus
occurrence,
  • Wells with no virus, but some E.
coli occurrence, and
  • Wells with neither E. coli nor virus
occurrence.
  The fractions of wells falling into
these four categories are named PI, P2,
 P3, and P4, respectively. The categories
 and parameters Pi through P4 are
 illustrated in the Venn diagram of
 Figure VII—1.
       Figure VII-1:  Categories of Indicator and Viral Classification Among PWS Wells in U.S.
                                                        P4
                                                 (no virus, no indicator)
  Because fecal contamination is
intermittent, viruses and E. coli will
only be present some fraction of time in
a contaminated well. These fractions
will vary from well to well and EPA has
modeled these different fractions as
distributions. One parameter pair
describes the distribution for viruses
and another parameter pair describes
the distribution for E. coli. These four
parameters, together with the fractions
of wells falling into the four categories,
are the parameters estimated in the
national occurrence model.
  The Economic Analysis for the Final
Ground Water Rule describes the
statistical methods used to estimate
model parameters (USEPA, 2006d). That
document details the statistical model,
estimation methods, and summary
results. The GWR EA also includes a
number of Exhibits that describe the
central estimates (means) and their
uncertainties.
  Central estimates for key parameters
are as follows:
  • Pi = percentage of wells having
virus, but no E. coli = 10 percent
  • P2 = percentage of wells having
both virus and E. coli = 16 percent
  • P3 = percentage of wells having E.
coli, but no virus = 10 percent
  • P4 = percentage of wells having no
virus and no E, coli = 64 percent
  • On average, wells with some virus
occurrence have detectable
concentrations 11 percent of the time.
  • On average, wells with some E. coli
occurrence have detectable
concentrations 14 percent of the time.
  EPA attempted to evaluate occurrence
based on the hydrogeologic
characteristics of the aquifer. However,
because very few data sets  allowed for
differentiation of viral or indicator
presence among sensitive versus non-
sensitive wells, no significant difference
in viral or indicator presence could be
discerned from the limited data.
Therefore, the same PI, P2, P3, and P4
estimates were assumed for all wells,
without regard to aquifer sensitivity.
  Although EPA could not stratify the
available viral occurrence data between
wells drawn from sensitive or non-
sensitive aquifers, EPA was able to
discern two classifications  of well type
according to overall vulnerability
characteristics (more and less
vulnerable wells). The data from
Lieberman et  al., 2002 were used to
represent virus concentrations in more
vulnerable wells and the combined  data
from Abbaszadegan et al., 2003 and
Lindsey et al., 2002 were used to
represent concentrations in less
vulnerable wells.
  EPA used acute and non-acute TCR
maximum contaminant level (MCL)
violation data to estimate the percent of
wells considered more vulnerable.
Based on this data, EPA estimated that
about 2.5 percent of wells in the U.S.,
which have  modeled viral presence,
would have viral concentrations like the
non-GWUDI wells in Lieberman et al.,
2002 (more vulnerable). Similarly, EPA
estimated that about 97.5 percent of the
wells in the  U.S. (100—2.5 percent)
which have  modeled viral presence
would have  concentrations  like those of
Abbaszadegan et al. (2003) and Lindsey
et al. (2002)  (less vulnerable).

2. Risk Analyses

  a. Baseline risk estimates. The
framework for developing the estimates
of baseline risk from consumption of
contaminated ground water is in
accordance with the standard
framework detailed in the EPA Policy
for Risk Characterization (USEPA,
1995a), EPA's Guidance for Risk
Characterization (USEPA, 1995b), and
EPA's Policy for  Use of Probabilistic
Analysis in Risk  Assessment (USEPA,

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65618   Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations
1997c). A complete discussion of EPA's
risk analyses in support of this rule can
be found in the GWR EA (USEPA,
2006d). The discussion below is an
overview of the analyses, focusing on
how information on occurrence,
exposure, and  dose-response is
combined to produce estimates of health
risk.
  EPA's occurrence model predicts the
fraction of wells that have some degree
of viral contamination. The model also
predicts degree of contamination, in
terms of the varying fractions of time
that viruses can be detected. In the
probabilistic risk analysis,  Monte Carlo
techniques are used to simulate large
numbers of wells with differing
fractions of time that virus is present.
  In addition to assigning different
fractions of time, the risk model also
assigns different concentration levels to
the simulated contaminated wells. Each
well is assigned one concentration value
and this is treated as the well's
concentration whenever the well has
virus present. EPA does this by
sampling from the actual virus
concentrations that were observed in the
occurrence studies. Viral concentrations
among more vulnerable wells are
sampled from the measured values of
non-GWUDI wells in the Lieberman et
al., 2002, study. Concentrations in less
vulnerable wells are sampled from those
measured in the Abbaszadegan, ef al.,
2003 and Lindsey et al., 2002 studies.
  EPA's risk model then estimates
exposure levels, or doses, for consumers
of the contaminated well water. A
consumer's dose on a day when virus is
present depends on the virus
concentration, the level of disinfection
employed by the water system, and the
volume of tap water that the consumer
ingests. For systems that do not
disinfect, the tap water is assumed to
have the same  virus concentration as the
source water. In contrast, properly
operating systems that disinfect are
assumed to inactivate 99 percent (2-log)
to more than 99.99 percent  (4-log) of
viral pathogens, depending on the
disinfection practices employed. A
consumer's daily dose is computed as
the product of the tap water
concentration, the fraction of viral
pathogens NOT inactivated and the
volume of water ingested.
  Next, the consumer's daily dose is
translated to risk of infection via EPA's
dose-response  modeling. EPA's risk
model applies  the calculated dose,
based on viral  cell culture measurement,
for both Type A and Type B viruses.
Daily probabilities of infection are then
derived on the basis of the daily dose,
according to dose-response models.
Annual probabilities of infection are
then derived from the daily estimates,
based on the number of days per year
in which a virus is expected to be
present.
  Next, morbidity factors (risk of illness
given infection), secondary spread of
illness to other individuals, and
mortality factors (risk of premature
death given  an illness), derived from the
literature, are used to estimate the
annual probability for illness and
premature death. EPA's risk assessment
model includes variability and
uncertainty  ranges for morbidity and
mortality to  account for different effects
in different subpopulations.
  b. Risk reduction estimates. The
methodology for estimating the
reduction in risk for the regulatory
alternatives  builds upon the approach
and assumptions used to establish the
baseline risk. The primary difference
between the modeling for estimating the
baseline risk model and the modeling
for estimating the risk reduction from a
given regulatory alternative is that the
latter incorporates a change in the
concentration of viral pathogens
reaching the finished drinking water of
the exposed population. These changes
reflect either a reduction in pathogen
concentration between source water and
finished water due to disinfection or the
elimination  of the pathogen from other
non-treatment corrective actions
addressing the source water
contamination. In addition to
accounting for the magnitude of
pathogen exposure reduction, an
important component of the risk
reduction modeling is to account for the
timing of when those reductions occur
over a 25 year analysis timeframe
following promulgation of the rule.
  For the baseline risk analysis, each
well in the simulation process is
designated as either having a virus
present at some time or never having a
virus present. For those wells having
some viral occurrence, values are
assigned for the virus concentration and
the fraction  of time that virus occurs.
The risk reduction part of the model
uses the exact same simulated wells as
those generated in the baseline risk part
of the model.
  For the sake of efficiency in
implementing the simulation modeling
process, those wells designated as never
having a virus present are recognized as
having zero  risk reduction potential and
are counted  as such in the model
outputs, but are not run through the
detailed steps of the risk reduction
model.
  For those  wells that do have a virus
present, the  risk reduction model
answers the following three questions:
  (1) Is a corrective action performed on
this well as a result of the regulatory
alternative being considered?
  (2) What is the finished water virus
concentration following corrective
action?
  (3) In what year following rule
implementation is the corrective action
performed?
  The risk reduction model then
processes the reduced virus
concentrations through the dose-
response functions for infectivity and
the morbidity and mortality factors as in
the baseline risk assessment.
  Estimates  of cases avoided, calculated
for all of the individual wells, are then
aggregated across all  wells to arrive at
the total national estimates of risk
reduction. In addition, some of the
assumptions and data used in the risk
reduction model are uncertain and are
therefore input  as uncertainty
distributions. As a result of the
uncertainty reflected in those inputs,
together with the uncertainty reflected
in other inputs  to the baseline risk
model that are also carried into the risk
reduction model, the output of the
model is a range of values of cases
avoided. The range is used by EPA to
determine the expected value and the 90
percent confidence bounds on that
expected value.
  The GWR EA (USEPA, 2006d)
describes in more detail the specific
assumptions and inputs—including
considerations of uncertainty—that are
used to model risk reduction for each of
the four rule options at the individual
well level and the aggregation of those
well level estimates to obtain the overall
national estimates of risk reduction.

C. What Are the Benefits of the GWR?
  The quantified benefits of this rule
result from reductions in endemic acute
viral illness  and death from two groups
of viruses (called Type A and Type B).
Type A virus is represented by rotavirus
and is highly infectious but has
essentially only mild health effects.
Type B virus is  represented by
enterovirus or echovims (a member of
the enterovirus  group) and is
moderately infectious, but can have
severe health consequences though the
majority of illnesses from Type B
viruses are also mild. Additionally, the
quantified benefits are based only on
endemic, acute  illness that occurs as a
result of virus in PWS wells under
normal operating conditions. Illnesses
due to treatment interruptions or
failures or to distribution system
deficiencies are not quantified. Bacterial
illnesses and deaths avoided are also
not quantified.

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           Federal Register/Vol. 71, No. 216/Wednesday, November 8, 2006/Rules and Regulations    65619
  As shown in Table VII—3 below, the
annualized present value of the
quantified benefits of this rule are $19.7
million (using a three percent discount
rate and an enhanced cost-of-illness
value that includes lost unpaid labor
(e.g., household production) and leisure
time for people within and outside the
paid labor force), with a 90 percent
confidence interval of $6.5 to  $45.4
million. Using traditional cost-of-illness
values at the same discount rate, the
annualized present value of the
quantified benefits of the rule are $10.0
million, with a 90 percent confidence
interval of $2.2 to $27.0 million. At a
seven percent discount rate and the
enhanced cost-of-illness value, the
annualized present value of the
quantified benefits are $16.8 million,
with a 90 percent confidence interval of
$5.5 to $38.6 million. Using the
traditional cost-of-illness values, the
annualized present value of the
quantified benefits are $8.6 million,
with a 90 percent confidence interval of
$1.9 to $22.9 million at a seven percent
discount rate.
                   TABLE VI1-3.—SUMMARY OF ANNUALIZED PRESENT VALUE QUANTIFIED BENEFITS
                                                   [SMillions, 2003$]
System type
Enhanced COi:
CWSs
NTNCWSs
TNCWSs
Total 	
Traditional COI:
CWSs
NTNCWSs
TNCWSs
Total 	
Annualized benefits at three percent
discount rate
Mean
$16.0
0.9
2.7
19.7
8.2
0.5
1.3
10.0
90 Percent confidence bound
Lower
(5th %ile)
$5.4
0.3
0.8
6.5
1.9
0.1
0.3
2.2
Upper
(95th %ile)
$37.0
2.2
6.2
45.4
22.3
1.3
3.4
27.0
Annualized benefits at seven percent
discount rate
Mean
$13.7
0.8
2.3
16.8
7.1
0.4
1.1
8.6
90 Percent confidence bound
Lower
(5th %ile)
$4.6
0.2
0.7
5.5
1.6
0.1
0.2
1.9
Upper
(95th %ile)
$31.6
1.8
5.1
38.6
19.1
1.0
2.8
22.9
  Note: Estimates are derived from independent model runs and, therefore, detail may not add to total. Values are for endemic viral illnesses
and deaths avoided over the 25-year period, expressed in annualized dollars. See VII.C.4 for additional rule benefits.
I. Calculation of Baseline Health Risk
  As part of the quantitative analysis to
determine the GWR benefits, EPA
estimated the "baseline risk" (pre-
GWR)—the number of people becoming
ill and/or dying each year from Type A
(represented by rotavirus) and Type B
(represented by enterovirus or
echovirus) viral infection due to
consumption of ground water from
public water supplies (see Table VII-4).
The risk analysis uses these two viruses
as surrogates for waterborne viruses.
The annual estimated number of viral
illnesses from exposure to Type A and
Type B viruses ranges from about 33,000
to 476,000 cases, with a mean of
approximately 185,000 cases. EPA
estimates that about 0.3 to 11 deaths per
year (mean of three deaths) prior to this
rule as a result of exposure to viruses.
These numbers are the "baseline" used
to estimate the health risk reduction and
their associated monetized value of risk
reduction due to implementation of this
rule. As discussed earlier, bacterial
illnesses and deaths are not considered
in the baseline, and only endemic, acute
viral illnesses from the two surrogate
viruses are considered.
  TABLE VII-4.—ESTIMATES OF BASELINE VIRAL ILLNESSES AND DEATHS DUE TO CONTAMINATION OF GROUND WATER
                                                     SYSTEMS

Virus type
Type A (rotavirus) 	 	 	
Type B (enterovirus or echovirus) 	 	
Total

Illnesses per year
Mean
175,168
10,018
185,186
5th-95th
Percentiles
32,652-435,381
501-40,718
33,153-476,099
Deaths per year
Mean
1.2
2.0
3.2
5th-95th
Percentiles
0.2-2.9
0.0-8.1
0.3-1 1 .0
2. Calculation of Avoided Illnesses and
Deaths

  The GWR requirements are projected
to result in a significant reduction in
exposure to fecal contamination. EPA
used a risk assessment model to
estimate the avoided viral illnesses and
deaths. The risk assessment model
estimates reductions in baseline
incidence considering the effects of the
sanitary survey and triggered source
water monitoring. Assessment source
water monitoring is optional and is not
included in this analysis (see Section
VII J.10). Table VII-5a shows the
calculated viral illnesses and deaths
avoided due to the GWR. The rule is
expected to avoid (mean value)
approximately 42,000 viral illnesses and
one viral death annually (averaged over
25 years). Details of the assumptions
and methodology used in the model are
described in the GWR EA (USEPA,
2006d). Table VII-5b shows the

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65620   Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations
calculated viral illnesses and deaths      GWR benefits assessment and all data
avoided due to the GWR by system type,  and analyses used in predicting those
More detailed information about the
                                       benefits can be found in the GWR EA
                                       (USEPA, 2006d).
             TABLE VII-SA.—SUMMARY OF ANNUAL VIRAL ILLNESSES AND DEATHS AVOIDED FOR THE GWR

Virus type
Type A (rotavirus)
Type B (enterovirus or echovirus)
Total 	
Illnesses avoided per year
Mean
39,442
2,426
41.868
5th-95th
Percentiles
10,093-79,925
181-8,114
10.274-88.039
Deaths avoided per year
Mean
0.3
0.5
0.7
5th-95th
Percentiles
0.1-0.5
0.0-1.6
0.1-2.1
  Note: Details may not add to totals due to independent rounding and independent statistical analyses.
  Source: GWR Illness Model.

            TABLE VII-5B.—SUMMARY OF ANNUAL AVOIDED VIRAL ILLNESSES AND DEATHS BY SYSTEM TYPE

System type
CWSs 	
NTNCWSs 	
TNCWSs 	
Total 	 	

Illnesses avoided per year
Mean
32,031
2,094
7,743
41,868
5th-95th
Percentiles
8,704-68,994
533-4,308
1,037-14,738
10,274-88,039
Deaths avoided per year
Mean
0.6
0.03
0.1
0.7
5th-95th
Percentiles
0.1-1.8
0.0-0.1
0.01-0.2
0.1-2.1
  Note: Estimates are derived from independent model runs, and, therefore, detail may not add to total. Values are endemic, acute viral ill-
nesses and deaths avoided following full implementation of the GWR and only accounts for rotavirus and echovirus.
  Source: Derived from GWR model output.
3. Derivation of Quantified Benefits
  EPA quantified the benefits for the
GWR based on reductions in the risk of
endemic, acute viral illness as explained
in Section VII.B.2. Next, EPA monetized
benefits for nonfatal viral illnesses and
mortalities avoided by the GWR. Table
VII-3 shows the estimated monetized
value for viral illnesses and deaths
avoided by the GWR.
  Benefits for nonfatal cases of endemic,
acute viral illness were calculated using
a cost-of-illness (COI) approach.
Traditional COI valuations focus on
medical costs and lost work time and
leave out significant categories of
benefits, specifically, the reduced utility
from being sick (i.e., lost personal or
nonwork time, including activities such
as child care, homemaking, community
service, time spent with family, and
recreation), although some COI studies
also include an estimate for unpaid
labor (household production) valued at
an estimated wage rate designed to
reflect the market value of such labor
(e.g., median wage for household
domestic labor).
  Ideally, a comprehensive willingness
to pay (WTP) estimate would be used
that includes all categories of loss in a
single number. However, a review of the
literature indicated that the available
studies were not suitable for valuing
acute viral illness; hence, estimates from
this literature are inappropriate for use
in this analysis. Instead, EPA presents
two COI estimates: a traditional
approach that only includes valuation
for medical costs and lost work time
(including some portion of unpaid
household production) and an enhanced
approach that also factors in valuations
for lost unpaid work time for employed
people, reduced utility (or sense of well-
being) associated with decreased
enjoyment of time spent in non-work
activities, and lost productivity at work
on days when workers are ill but go to
work anyway. The first two categories of
loss are estimated by multiplying the
average wage rate by the number of non-
work waking hours. The third category
is estimated by multiplying all waking
hours (work and non-work) by 30
percent of the wage rate for days when
subjects are ill but report for work
anyway.
  The computation of COI involves two
broad categories of costs—direct and
indirect medical costs. All costs are
updated to a common year (2003) used
as the starting point for projecting
benefits into future time periods. For
Type A viruses, each cost component
has a separate estimate made based on
age and the health state of the
individual (healthy or
immunocompromised). For Type B
viruses, cost components  have separate
estimates based both on age and on the
type of care required (i.e., no medical
care, outpatient care, or inpatient care).
Chapter 5 of the GWR EA (USEPA,
2006d) has a detailed breakout of both
Type A and Type B COI estimates.
  For both the Enhanced COI and
Traditional COI, the direct cost for a
case of Type A or Type B viral illness
is derived by summing the costs of
outpatient and inpatient care (in 2003$).
Outpatient  care consists of an initial
physician visit ($114.55) and the
product of the cost of each follow-up
visit ($66.18) and the number of follow-
up visits. Multiplying this sum by the
percentage  of patients that utilize
outpatient services yields the weighted
unit cost of outpatient care. The cost of
inpatient care consists of the costs of the
initial doctor visit in the hospital
($152.87), any follow-up visits ($52.25),
and the hospital charges (calculated on
a per day basis, with costs ranging from
$1,007 per day for Type A illnesses to
$4,870 per day for a severe case of Type
B illness). As with outpatient costs,
multiplying the sum of doctor visits and
hospital charges by the percentage of
patients who require inpatient care
yields the weighted unit cost of
inpatient care.
  The sum of the weighted unit costs of
outpatient and inpatient care equals the
weighted direct costs. The weighted
direct medical costs per case of Type A
viral illness ranges from an average cost
of $0 (for healthy patients, five years old

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           Federal  Register/Vol.  71,  No. 216/Wednesday, November 8,  2006/Rules  and Regulations    65621
and up requiring no medical care) to
$4,486 (for immunocompromised
patients younger than five years old).
The weighted direct medical costs per
case of Type B viral illness range from
an average of $0 (for patients requiring
no medical care) to $23,431 (for patients
less than one month old requiring
inpatient care).
  Total indirect cost is the sum of the
value of patient days lost, the value of
productivity lost, and the value of care
giver days lost. For the Enhanced COI,
the total indirect cost associated with a
case of Type A viral illness ranges from
an average of $103 (for healthy patients
16 years old and older) to $2,136 (for
immunocompromised patients under
two years of age). Indirect costs
associated with cases of Type B viral
illness range from $336 (for patients 16
years old and older requiring no
medical care) to $2,990 (for patients
under 16 years of age requiring inpatient
care).
  For the Traditional COI, the total
indirect cost associated with a case of
Type A viral illness ranges from an
average of $39 (for healthy patients 16
years old and older) to $426 (for
immunocompromised patients two
years of age and younger). Indirect costs
associated with cases of Type B viral
illness range from $126 (for patients 16
years old and older requiring no
medical care) to $596 (for patients
requiring inpatient care).
  The valuation of children's time
presents unique problems. The best
approach when valuing children's
health effects is the use of child-specific
valuations of these effects. For direct
costs, EPA has used such valuations.
Indirect costs, however, prove more
challenging. As noted in the Children's
Health Valuation Handbook (USEPA,
2003c), "(children's! time lost to
sickness also has value, although no
direct measure exists for this loss." In
this instance, the Handbook states that,
"as a second-best option, *  *  * transfer
benefit values estimated for adults to
children." The Enhanced COI uses this
guideline, in conjuncture with
Executive Order 13045 ("Protection of
Children from Environmental Health
Risks and Safety Risks"), and assumes a
day lost due to illness (lost patient day)
for the duration of illness for patients
younger than 16 years to be valued at
$199.36 (based on the median post-tax
wage). In contrast, the Traditional COI
assigns no lost patient day value for
children under 16 years of age because
this approach assigns a monetary value
only to lost wages (or lost unpaid work
time for adults not in the paid labor
market). Both the Traditional and
Enhanced COI approaches assume that
a caregiver stays home with these
children, introducing additional lost
caregiver days for each lost patient day.
The number of days lost entirely to
illness, either by the adult patient or
caregiver, is multiplied by $227.79 (for
the Enhanced COI) or $85.12 (for the
Traditional COI), the average value of a
lost day.
  In addition, for days when an
individual is well enough to work but
still experiencing symptoms, such as
diarrhea, the Enhanced COI estimate
also includes a 30 percent loss of work
and leisure productivity (i.e. 30 percent
of the wage rate times 16 hours) based
on a study of giardiasis illness
(Harrington et al., 1985). In the
Traditional COI analysis, productivity
losses are not included for either work
or nonwork time. No productivity losses
are assigned to children under 16 years
of age under either the Traditional or
Enhanced COI approaches.
  The Agency believes that losses in
productivity and lost leisure time are
unquestionably present and that these
categories have positive value;
consequently, the Traditional COI
estimate understates the true value of
these loss categories. However, using
the wage rate to estimate the loss of
utility during non-work hours may
understate or overstate the value of this
loss, depending on severity of illness
and other factors. Similarly, using 30
percent of the wage rate to estimate the
value of lost productivity in work and
leisure when a person is still
experiencing symptoms but is well
enough to go to work may understate or
overstate benefits. EPA notes that these
estimates should not be regarded as
upper and lower bounds. In particular,
the Enhanced COI estimate may not be
an upper bound, because it may not
fully incorporate the value of pain and
suffering.
  As with the avoided mortality
valuation, the real wages used in the
COI estimates were increased by a real
income growth factor that varies by
year, but is the equivalent of about 1.8
percent per year over the  25-year period.
This approach of adjusting for real
income growth was recommended by
the SAB (USEPA, 2000d) because the
median real wage is expected to grow
each year (by approximately 1.8
percent). Correspondingly, the real
income growth factor of the COI
estimates increases by the equivalent of
1.8  percent per year (except for medical
costs, which are not directly tied to
wages).
  Reductions in mortalities were
monetized using EPA's standard
methodology for monetizing mortality
risk reduction. This methodology is
based on a distribution of value of
statistical life (VSL) estimates from 26
labor market and stated preference
studies. For this analysis, EPA
incorporated the Weibell Distribution
into the benefit model Monte-Carlo
simulation and updated the VSLs to
2003 dollars. The updated mean VSL in
2003 dollars is $7.4 million. A real
income growth factor was applied to
these estimates of approximately 1.8
percent per year for the 25-year time
span following implementation. Income
elasticity for VSL was estimated as a
triangular distribution that ranged from
0.08 to 1.00, with a mode of 0.40. VSL
values for the 25-year time span are
shown in the GWR EA in Exhibit B.6
(USEPA, 2006d). A more detailed
discussion of these studies and the VSL
estimate can be found in EPA's
Guidelines for Preparing Economic
Analyses (USEPA, 2000c).

4. Nonquantifiable Benefits
  There are substantial benefits
attributable to the GWR that are not
quantified as part of this rulemaking
because of data limitations. The GWR
quantifies only the endemic, acute
illnesses and deaths due to rotavirus
and enterovirus. By reducing bacterial
and other viral illnesses and deaths, this
rule provides significant health benefits
beyond the monetized benefit estimates.
Chronic illnesses (such as diabetes,
dilated cardiomyopathy, and reduced
kidney function), kidney failure, and
hypertension (e.g., Garg et al., 2005)
resulting from waterborne viral and
bacterial pathogens are also not
quantified but provide additional
benefits, although such cases are likely
to be relatively rare. Additional health
benefits will accrue from preventing
outbreaks, reducing periods with
insufficient disinfection, and
minimizing contaminant infiltration
into distribution systems.
  This rule will also result in non-
health benefits such as avoided outbreak
response costs,  increased information
gained through source water monitoring
that will in turn provide benefits to the
systems and their customers, and
reduced uncertainty regarding drinking
water safety, which may lead to reduced
costs for averting behaviors.
  In addition, the optional assessment
source water monitoring provision will
provide additional benefits similar to
those already described (i.e. reduction
in viral and bacterial illness). However,
EPA was not able to quantify either the
benefits or costs of this program because
EPA does not know the extent to which
States will use the option or the manner
in which they will implement it.
Because this provision could potentially

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65622    Federal Register/Vol. 71, No. 216/Wednesday, November 8,  2006/Rules  and  Regulations
increase both benefits and cost, a more
complete discussion can be found in the
Section VII. J. 10 of this preamble.
  EPA believes that, collectively, these
benefits, both health and non-health,
significantly exceed those which EPA
was able to quantify and are a major
basis for supporting the preferred
regulatory alternative. A qualitative
discussion of these nonquantified
benefits is included in Section 5.4 of the
GWR EA (USEPA, 2006d); a summary of
this discussion appears below.
  a. Decreased incidence of illness from
bacteria. In addition to reducing the
number of illnesses and deaths due to
drinking water related to some viral
illnesses, the ground water source
monitoring and corrective actions taken
under the GWR will also reduce the
number of illness and deaths due to
bacteria in drinking water. EPA was
unable to quantify the benefits from
preventing bacterial illness; however,
EPA provides a rough estimate of
illnesses and deaths prevented through:
  • Estimating potential bacterial
illnesses avoided;
  • Estimating a mortality rate for
waterborne bacterial illness; and
  • Estimating potential annual deaths
avoided by the GWR.
  The first of the analytical steps
applies the ratio of waterborne disease
outbreak incidence rates between
bacteria and viruses to the quantified
viral cases avoided to  estimate bacterial
cases avoided. The second analytical
step derives mortality rates for types of
bacterial illness associated with
waterborne disease outbreaks. The third
analytical step combines the first two
steps to devise a rough estimate of
annual bacterial deaths avoided. EPA
estimates that total quantified benefits
could increase by a factor of five if EPA
was able to account for additional
deaths and hospitalizations caused by
bacterial illness being avoided (i.e., not
even considering the value of reduced
non-fatal non-hospitalization caused
bacterial illnesses). More information on
this calculation can be found in Chapter
5 of the GWREA (USEPA, 2006d).
  b. Decreased illness from other
viruses. Quantified benefits accrue from
endemic, acute illnesses associated with
rotavirus (a Type A virus) and
enterovirus or echovirus (a Type  B
virus) as discussed previously.
Nonquantified health  benefits
attributable to viruses include decreased
incidence of gastroenteritis caused by
other Type A viruses such as norovirus,
astrovirus, and adenovirus; decreased
incidence of other acute disease
endpoints (e.g., hepatitis and
conjunctivitis) caused by types of
viruses not modeled in the quantified
benefits analysis; and decreased
incidence of chronic illness associated
with Type B virus (e.g., diabetes and
dilated cardiomyopathy).
  The health effects of norovirus (the
most common Type A virus) illness
include acute onset of nausea, vomiting,
abdominal cramps, and diarrhea
(USEPA, 2006d). EPA believes that
nausea and vomiting associated with
norovirus, typically absent in rotavirus
illness, suggest that the norovirus
disease burden (e.g., number of
productive days lost) associated with
PWS wells is important, especially for
adults with whom norovirus disease is
quite prevalent. EPA believes that if
norovirus were included in the
quantified benefits, there would be
significantly greater monetized benefits
for Type A viruses, because monetized
rotavirus disease burden (the only Type
A virus modeled) provides only a small
benefit for adults since most adults are
immune to rotavirus.
  Other acute and chronic viral
illnesses can be acquired from
consuming ground water contaminated
with other Type A or Type B viruses,
but the Agency was unable to quantify
or monetize them. These include severe,
acute illnesses such as hepatitis A;
milder, acute illnesses such as
conjunctivitis; and severe chronic
illnesses such as diabetes and dilated
cardiomyopathy. Most chronic illnesses
are costly to treat. Lifetime costs
associated with a new case of diabetes,
for example, assuming an average
illness duration of 30 years, are
estimated at $227,032 using a three
percent discount rate and $143,733
using a seven percent discount rate
(year 2003 dollars). For dilated
cardiomyopathy, the lifetime (21  year
average) cost is $61,117  (seven percent
discount rate, year 2003 dollars).  These
illnesses are discussed in further detail
in the GWR EA (USEPA, 2006d).
  c. Other nonquantifiable benefits.
Other nonquantified health benefits
include decreased incidence of
waterborne disease outbreaks and
epidemic illness and decreased illness
through minimizing treatment failures
or fewer episodes with inadequate
treatment. The nonquantified non-
health benefits include  improved
perception of ground water quality and
perception about reduced risk
associated with PWS wells, potential
reduced use of bottle water and point-
of-use devices, reduced time spent on
averting behavior such as obtaining
alternative water supplies, and avoided
costs associated with outbreak response.
  Pathogenic protozoa can occur in
PWS wells, typically when such
systems are misclassified and are not
recognized as GWUDI systems. In PWSs
with elevated ground water
temperatures, Naegleria fowleri can
colonize the distribution system, well,
well gravel-pack, or aquifer. N. fowleri
is fatal when inhaled (and treatment is
not timely) and two five-year old boys
died in the same week from exposure
via a GWS in Arizona (Marciano-Cabral
et al., 2003). N. fowleri is inactivated by
disinfection, so corrective  action
implemented as the result of this rule
that includes disinfection may prevent
death from this organism. However, the
benefits from avoiding these deaths are
nonquantified. Cryptosporidiosis and
giardiasis  outbreaks in sensitive PWS
wells have also occurred (see Section
III.C.2). Sanitary surveys and additional
monitoring under the GWR combined
with existing source water assessments
and Long Term 2 Surface Water
Treatment Rule (LT2ESWTR) (71 FR
654, January 5,  2006) (USEPA,  2006i)
implementation can, in combination,
minimize  the likelihood of
misclassification of PWS wells (as non-
GWUDI) and reduce the likelihood of
outbreaks  associated with  such
misclassification. This rule only
qualitatively considers the benefits of
identifying misclassified PWS wells.
  Several  nonhealth benefits from this
rule were  also recognized by EPA but
were not monetized. The nonhealth
benefits of this rule include avoided
outbreak response costs (such as the
costs of providing public health
warnings,  boiling drinking water and
providing alternative supplies,
remediation and repair, and testing and
laboratory costs). Expenses associated
with outbreaks  can be 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 $43 million in
Canadian  dollars (approximately $32
million in U.S.  dollars) (Livernois,
2002). The author believed that this was
a conservative estimate.

5. How Have the Benefits Changed
Since the Proposal?
  The estimated annual quantified
benefits for the  GWR have changed from
$205 million (year 2000 dollars, both at
3 percent and 7 percent discount rates)
to $19.7 million (year 2003 dollars, at 3
percent) using enhanced cost-of-illness
estimates and $10.0 million (year 2003
dollars, at 3 percent) using traditional
cost-of-illness estimates (these are $16.8
and $8.6 using a 7 percent discount
rate). The  proposal only included the
enhanced  cost-of-illness measure. The
change in  quantified benefits is due to

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Federal Register/Vol.  71,  No. 216/Wednesday, November  8,  2006/Rules and Regulations
                                                                                                             65623
 changes in both the economic analysis
 estimates (e.g., interpretation of
 occurrence and other data) and GWR
 provisions. However, changes in the
 economic analysis estimates are the
 dominant factor in explaining the large
 change in benefits from the proposal.
  Estimates in the GWR EA that were
 changed and that most influenced the
 change in the quantified benefit
 estimate include:
  • Frequency and duration of viral
 occurrence in  wells;
  • Percentage of wells associated with
 high versus low viral concentrations;
  • Efficiency by which virally
 contaminated  wells are identified and
 prescribed corrective action;
  • Severity of symptoms associated
 with predicted illnesses
  • Monetized value of illnesses
 avoided; and
  • Using net present values and then
 annualizing benefits.
  EPA believes that the changes made
 in the GWR EA since proposal
 substantially improve upon the
 scientific basis for the quantified
 benefits, a major issue raised by public
 comments (see Section VII. J of this
 preamble  for further discussion of
                            public comments). Chapter 5 of the
                            GWR EA describes the basis for the
                            analysis (USEPA, 2006d).
                              Changes in the rule provisions also
                            impacted the final benefit estimate but
                            these changes are not as significant as
                            the changes made in the economic
                            analysis. In addition, the benefits (as
                            well as costs) for the optional
                            assessment source water monitoring and
                            additional  fecal indicator sampling
                            following triggered source water
                            monitoring are not included in the final
                            rule analysis. These potential impacts
                            are discussed in Section VII.J. 10.
                              Another  major change in the GWR EA
                            since proposal is a more thorough
                            analysis of the nonquantified benefits.
                            EPA's analysis of the potential  benefits
                            from avoided bacterial illness suggests
                            that the nonquantified benefits may
                            exceed the  quantified benefits by a
                            factor of five (see Chapter 5.4 of the
                            GWR EA for a full description of
                            nonquantified benefits, USEPA, 2006d).
                            D. What Are the Costs of the GWR?

                            I. Summary of Quantified Costs
                              In estimating the costs of this rule, the
                            Agency considered impacts on  public
 water systems and on States. Table VII-
 6 summarizes these costs in terms of
 annualized present value: $61.8 million
 (using a three percent discount rate) and
 $62.3 million (using a seven percent
 discount rate). Most costs occur early in
 the implementation schedule, therefore
 the values do not differ much using
 different discount rates.
  To calculate the national costs of
 compliance, the Agency used a Monte-
 Carlo simulation model specifically
 developed for the GWR. The main
 advantage of this modeling approach is
 that in addition to providing average
 compliance costs, it also estimates the
 range of costs within each PWS size and
 category. It also allows the Agency to
 capture the variability and uncertainty
 in areas such as PWS configuration,
 current treatment in-place, source water
 quality, existing State requirements,
 unit costs of treatment technologies, and
 compliance forecasts. The 90 percent
 confidence bounds shown in Table VII-
 6 reflect the quantified uncertainties.
      Table VII-6: Total Annualized Present Value Costs (SMillions, 2003$)
Discount
Rate
3 percent
7 percent
Systems
Mean
Value
$ 50.0
S 50.6
90 Percent
Confidence Bound
Lower
(5th %ile)
$ 34.3
$ 35.2
Upper
(95th %ile)
$ 68.8
$ 69.0
States
Mean-
Value
$ 11.8
$ 11.7
90 Percent
Confidence Bound
Lower
(5th %ile)
$ 10.9
$ 10.9
Upper
(95th %ile)
$ 12.6
$ 12.6
Total
Mean
Value
S 61.8
S 62.3
90 Percent
Confidence Bound
Lower
(5th %ile)
S 45.2
$ 46.1
Upper
(95th %ile)
$ 81.4
$ 81.6
      Notes:  . Detail may not add to totals due to independent rounding.
  Table VII-6 shows the estimated
annualized present value costs of this
rule. Drinking water utilities will incur
approximately 81 percent of the rule's
costs. States will incur the remaining
costs of the rule. In addition to the mean
estimates of costs, the Agency
                            calculated 90 percent confidence
                            intervals by considering, for example,
                            the uncertainty in the mean unit
                            technology costs. Table VII-7 shows the
                            undiscounted capital costs and all one-
                            time costs for both water systems and
                            States. The derivation of these cost
numbers can be found in Chapter 6 of
the GWR EA (USEPA, 2006d). The
itemized costs of this rule are presented
below for systems and States,
respectively.

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65624    Federal Register/Vol. 71, No.  216/Wednesday, November  8, 2006/Rules and Regulations

      Table VII-7:  Total Initial Capital and One-Time Costs (SMillions, 2003$)

CWS Total Initial Capital
NTNCWS Total Initial Capital
TNCWS Total Initial Capital
Total Initial PWS Capital Costs
CWS Implementation Costs
NTNCWS Implementation Costs
TNCWS Implementation Costs
Total One-rime PWS Costs
State Start-Up Cost
Total State One-Time Costs
PWSs Serving <10,000
Mean
Value
$ 79
$ 31
$ 173
$ 283
$ 5
$ 2
$ 9
$ 16
90 Percent
Confidence Bound
Lower
(Sth %ile)
$ 29
$ 12
$ 64
$ 105
$ 5
$ 2
$ 9
$ 16
Upper
(95th %ile)
$ 158
$ 60
$ 339
$ 556
$ 5
$ 2
$ 9
$ 16
PWSs Serving > 10,000

Mean
Value
$ 62
$ 0
$ 1
$ 64
$ 0
$ 0
$ 0
$ 0
90 Percent
Confidence Bound
Lower
(Sth %ile)
$ 24
$ 0
$ 0
$ 24
$ 0
$ 0
$ 0
$ 0
Upper
(95th %ile)
$ 117
$ 1
$ 2
$ 120
$ 0
$ 0
$ 0
$ 0

Total

Mean
Value
$ 141
$ 31
$ 174
% 346
$ 5
$ 2
$ 9
$ 17
$ 13
$ 13
90 Percent
Confidence Bound
Lower
(Sth %ile)
$ 53
$ 12
$ 64
$ 129
$ 5
$ 2
$ 9
$ 17
$ 13
$ 13
Upper
(95th %ile)
$ 275
$ 61
$ 341
$ 676
$ 5
$ 2
$ 9
$ 17
$ 13
$ 13
      Notes:  Detail may not add to totals due to independent rounding.
            The mean and confidence bounds are equal for both systems and state implementation costs because EPA derived these costs from point estimates.
2. Derivation of Quantified Costs
  a. Summary of Baseline Estimate. To
quantify the effects of the rule, it is
necessary to have a baseline against
which to compare the set of regulatory
requirements. The baseline is a
characterization  of the industry and its
operations under the conditions
expected to exist before systems make
changes to meet  requirements of this
rule. As discussed in Section IV of this
preamble, the regulatory requirements
can be system, entry point, or well level
requirements. These requirements, to a
large extent, depend upon the levels of
existing protection from microbial risks,
e.g., disinfection levels. Table VII-8a
presents the major baseline information
for this rule. The number of entry  points
or wells varies by system size, with
larger systems generally having more
entry points. Chapter 4 of the GWR EA
for this rule provides a detailed
description of the GWR baselines
(USEPA, 2006d).
  b. Rule Implications. To calculate the
cost impact of each rule alternative on
GWSs, the Agency estimated how  many
systems and their associated entry
points to distribution systems and wells
would be affected by the various rule
requirements based on national fecal
indicator occurrence information, as
discussed in Section VII.B.I. The
Agency developed compliance forecast
estimates that predict the number of
systems, entry points, or wells that
incur costs to comply with each
regulatory requirement. Table VII-8b
shows these numbers broken down by
system type and size category. Chapter
6 of the GWR EA for this rule provides
further description of the estimates of
rule implications (USEPA, 2006d).
  c. System Costs. This rule is estimated
to cost public GWSs $50.0 million
annually using a three percent discount
rate ($50.6 million annually using a
seven percent discount rate). The cost
impacts to systems complying with the
GWR stem from implementing the rule,
assisting with sanitary surveys,
performing source water and
compliance monitoring, and  performing
corrective actions. Not every system is
expected to incur all of these costs
because the compliance activities for
systems depend on the results from
sanitary surveys, analysis of total
coliform samples under the TCR, and
source water monitoring.
  The estimated costs for each of the
rule requirements are summarized in
Table VII-8c with a mean, upper bound,
and lower bound. The mean and
confidence bounds are equal for some of
the costs because EPA derived these
costs from point estimates. The total
annualized costs to systems are
presented in Table VII-9 by system size
and type. The detailed calculation of
these cost numbers are presented in
Chapter 6 of the GWR EA (USEPA,
2006d).
  To analyze the different rule
components, the Agency had to
distinguish between correction of
significant deficiencies identified
during sanitary surveys and the
corrective actions that result from fecal
indicator-positive ground water source
samples. It was not possible  to estimate
costs for all conceivable corrective
actions that a system may potentially
encounter on a national  level due to
system-to-system variability. As a result,
the Agency estimated costs for
representative corrective actions that
may be implemented to address
significant deficiencies identified by
sanitary surveys and  source water fecal
contamination, respectively. Table VII—
10 shows the representative corrective
actions.
BILLING CODE 6560-50-P

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    Federal Register/Vol. 71, No. 216/Wednesday, November 8, 2006/Rules and Regulations   65625
Table VII-8a:  GWR Baselines: Number of Systems, Entry Points, and Wells
System Size

Total Number
of Systems
A
Community Water Systems (CWSs)
<100
101-500
501-1,000
1.001-3.300
3.301-10K
10.001-50K
50.001-100K
100.001-1 Million
> 1 Million
12.843
14,358
4.649
5,910
2.884
1.444
167
103
3
Number of
Entry Points
per System
B

1.3
1.6
2.0
2.4
3.2
5.6
11.3
12.4
11.4
Nontransieni Noncommunity Water Systems (NTNCWSs)
<100
101-500
501-1.000
1.001-3.300
3.301-10K
10.001-50K
50.001-100K
100,001-1 Million
> 1 Million
9,456
6.758
1.894
715
73
10
1
1
-
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
Transient Noncommunity Water Systems (TNCWSs)
<100
101-500
501-1.000
1,001-3,300
3.301-10K
10,001-SOK
50.001-100K
100.001-1 Million
> 1 Million
64,448
18.993
1,940
585
74
19
1
1
-
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
1.0
Number of
Wells per
System
c

1.5
2.0
2,3
3.1
4.6
9.8
16.1
499
49.9

1.5
2.0
2.3
3.1
4.6
9.8
16.1
49.9
49.9

1.5
2.0
23
3.1
4.6
9.8
16.1
49.9
49.9
Number of
Wells per
Entry Point
D=C/B

1.1
1.2
1.2
1.3
1.4
1.7
1.4
4.0
4.4

1.5
2.0
2.3
3.1
4.6
9.8
16.1
49.9
49.9

1.5
2.0
2.3
3.1
4.6
9.8
16.1
49.9
49.9
Entry Points
with at least 4
logs of Viral
Disinfection
e

3.996
8.873
3.547
5.378
3.547
3,856
583
545
34

850
608
170
64
7
1
0
0


1.160
342
35
11
1
0
0
0
-
Entry Points with
less than 4 logs
of Viral
Disinfection
F

3,689
8.191
3,274
4,964
3,274
3,559
538
503
-

1,892
1.352
379
143
15
2
0
0


10.441
3,077
314
95
12
3
0
0

Entry Points
without
Disinfection
G

9.168
6.343
2.262
4,002
2.459
698
770
227


6.714
4.798
1.345
508
52
7
1
1
-

52,847
15.574
1.591
480
61
16
1
1
-

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65626    Federal Register/Vol. 71, No. 216/Wednesday,  November 8, 2006/Rules and Regulations




   Table VII-8b: Summary of Rule Implications
System Size

Systems
Receiving
Sanitary
Survey
A
Systems with
Corrective
Actions for
Significant
Deficiencies
B
Community Water Systems (CWSs)
<100
101-500
501-1,000
1,001-3,300
3.301-10K
10.001-50K
50.001-100K
100,001-1 Million
> 1 Million
12,843
14,358
4,649
5,910
2.884
1,444
167
103
3
2.181
2,444
789
1,001
492
245
28
18

Entry Points
with
Triggered
Monitoring
c

12.797
14,819
5,578
8,910
5.638
4.357
1,295
749
-
Nontransient Noncommunity Water Systems (NTNCWSs)
<100
101-500
501-1,000
1,001-3,300
3.301-10K
10,001-SOK
50.001-100K
100,001-1 Million
> 1 Million
9,456
6,758
1,894
715
73
10
1
1
-
1.608
1,148
322
121
12
2
0
0

Transient Noncommunity Water Systems (TNCWSs)
<100
101-500
501-1,000
1,001-3,300
3.301-10K
10,001 -50K
50,001-100K
100.001-1 Million
> 1 Million
64,448
18,993
1,940
585
74
19
1
1
-
10,990
3,234
329
99
13
3
0
0
-
8,609
6,149
1,724
651
66
9
1
1
-

63,295
18,648
1.905
574
73
19
1
1
-
Entry Points
with
Corrective
Actions for
Triggered
Monitoring
D

1,249
1,625
608
712
617
655
226
136
-

687
533
149
86
10
2
0
0
-

6,915
2,026
208
76
12
3
0
0
-
Entry Points with
Viral Disinfection
Increased from
less than 4 logs
to 4 logs
E

358
917
360
396
353
548
93
94
-

150
119
33
19
2
0
0
0
-

1,143
337
35
12
2
1
0
0
-
Previously Non-
disinfecting Entry Points
Taking Corrective Action
F

891
709
248
317
264
107
133
42
-

537
415
117
67
8
1
0
0
-

5,772
1,689
174
63
10
3
0
0
-
Entry Points
with
Incremental
Compliance
Monitoring
G'

248
292
105
130
111
54
46
20
-

149
170
50
27
3
1
0
0
-

1,602
696
73
26
4
1
0
0

    *G indicates number of entn1 points with treatment corrective actions. F-G indicates non treatment corrective actions

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    Federal Register/Vol. 71, No. 216/Wednesday, November 8, 2006/Rules and Regulations   65627
Table VII-8c:  Annualized Costs for Meeting Each of the GWR Provisions to Systems and
States (SMillions, 2003$)



Rule
Implementation &
Annual
Administration
A
Sanitary
Surveys
B
Corrective
Actions for
Significant
Deficiencies
c
Triggered
Monitoring
o
Corrective Actions
for Triggered
Monitoring
E
Compliance
Monitoring
F
Total Costs
G
3%
Systems
States
Total
Mean
Lower Bound
(5th %ile)
Upper Bound
(95th %ile)
Mean
Lower Bound
(5th %ile)
Upper Bound
(95th %ile)
Mean
Lower Bound
(5th %ile)
Upper Bound
(95th %ile)
$0.93
$0.93
$0.93
' $9.20
$9.20
$9.20
$10.13
$10.13
$10.13
$0.21
$0.11
$0.31
$1.45
$0.66
$2.23
$1.66
$0.77
$2.54
S8.46
$5.74
$11.60
$0.56
$0.52
$0.61
$9.02
$6.25
$12.21
S5.44
$5.32
$5.56
$0.09
$0.06
$0.12
S5.52
$5.38
$5.67
$25.64
$14.90
$38.39
$0.46
$0.32
$0.61
$26.10
$15.22
$39.00
$9.35
$3.02
$16.97
$0.00
$0.00^
$0.01
$9.36
$3.02
$16.98
S50.02
$34.28
$68.76
$11.77
$10.87
$12.64
$61.79
$45.15
$81.41
7%
Systems
States

Total

Mean
Lower Bound
(5th %ile)
Upper Bound
(95th %ile)
Mean
Lower Bound
(5th %ile)
Upper Bound
(95th %ile)
Mean
Lower Bound
(5th %ile)
Upper Bound
(95th %ile)
$1.33
$1.33
$1.33
$9.18
$9.18
$9.18
$10.51
$10.51
$10.51
$0.20
$0.10
$0.30
$1.39
$0.63
$2.14
$1.59
$0.74
$2.44
S8.13
$5.51
$11.14
$0.54
$0.50
$0.59
$8.67
$6.01
$11.73
$5.39
$5.27
$5.51
$0.10
$0.07
$0.13
$5.48
$5.34
$5.64
$27.20
$15.89
$40.96
$0.52
$0.36
$0.69
$27.72
$16.26
$41.65
$8.32
$2.65
$15.17
$0.00
$0.00
$0.01
$8.32
$2.65
$15.18
$50.57
$35.22
$69.00
$11.74
$10.87
$12.61
$62.31
$46.09
$81.61

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65628   Federal Register/Vol. 71, No.  216/Wednesday,  November 8, 2006/Rules  and  Regulations
       Table VII-9:  Total Annualized Costs to Systems by System Size and Type (SMillions,
       2003$)
System Size
(Population Served)
At 3%
Mean
Value
90 Percent
Confidence Bound
Lower
(5th %ile)
Upper
(95th %ile)
At 7%

Mean
Value
90 Percent
Confidence Bound
Lower
(5th %ile)
Upper
(95th %ile)
Community Water Systems (CWSs)
<100
101-500
501-1,000
1,001-3,300
3.301-10K
10,001-SOK
50,001-100K
100.001-1M
>1 Million
All Sizes
$ 2.91
$ 3.61
$ 1.45
$ 1.96
$ 2.23
$ 2.85
$ 1.78
$ 1.89
$ 0.00
$ 18.67
$ 2.13
$ 2.54
$ 0.99
$ 1.29
$ 1.40
$ 1.87
$ 1.01
$ 1.14
$ 0.00
$ 12.39
$ 3.69
$ 4.94
$ 1.98
$ 2.76
$ 3.26
$ 4.06
$ 2.73
$ 2.89
$ 0.00
$ 26.31
$ 2.91
$ 3.59
$ 1.44
$ 1.94
$ 2.26
$ 3.05
$ 1.88
$ 2.12
$ 0.00
$ 19.19
S 2.16
$ 2.60
$ 1.00
$ 1.30
$ 1.49
$ 2.05
$ 1.11
$ 1.31
$ 0.00
$ 13.03
$ 3.72
$ 4.83
$ 1.94
$ 2.69
$ 3.25
$ 4.41
$ 2.84
$ 3.18
$ 0.00
$ 26.87
Nontransient Noncommunity Water Systems (NTNCWSs)
<100
101-500
501-1,000
1,001-3,300
3.301-10K
1 0,001 -50K
50.001-100K
100,001-1 M
>1 Million
All Sizes
$ 1.77
$ 1.86
$ 0.67
$ 0.46
$ 0.10
$ . 0.04
$ 0.01
$ 0.01
$
$ 4.91
$ 1.34
$ 1.21
$ 0.43
$ 0.28
$ 0.05
$ 0.02
$ 0.00
$ 0.00
$
$ 3.33
$ 2.27
$ 2.60
$ 0.97
$ 0.68
$ 0.16
$ 0.07
$ 0.01
$ 0.01
$
$ 6.77
$ 1.78
$ 1.83
$ 0.66
$ 0.46
$ 0.10
$ 0.04
$ 0.01
$ 0.01
$
$ 4.89
$ 1.34
$ 1.23
$ 0.42
$ 0.28
$ 0.06
$ 0.02
$ 0.00
$ 0.00
$
$ 3.36
$ 2.26
$ 2.53
$ 0.94
$ 0.67
$ 0.17
$ 0.07
$ 0.01
$ 0.02
$
$ 6.68
"ransient Noncommunity Water Systems (TNCWSs)
<100
101-500
501-1,000
1,001-3,300
3,301-1 OK
10.001-50K
50,001 -100K
1 00,001 -1M
>1 Million
All Sizes
TOTAL
$ 17.74
$ 7.07
$ 0.98
$ 0.42
$ 0.13
$ 0.08
$ 0.01
$ 0.01
$
$ 26.44
$ 50.02
$ 12.87
$ 4.75
$ 0.58
$ 0.25
$ 0.07
$ 0.04
$ 0.00
$ 0.01
$
$ 18.56
$ 34.28
$ 23.27
$ 9.95
$ 1.45
$ 0.63
$ 0.21
$ 0.14
$ 0.01
$ 0.02
$
$ 35.68
$ 68.76
$ 17.86
$ 7.00
$ 0.96
$ 0.42
$ 0.14
$ 0.09
$ 0.01
$ 0.01
$
$ 26.49
$ 50.57
$ 13.11
$ 4.76
$ 0.59
$ 0.26
$ 0.07
$ 0.04
$ 0.00
$ 0.01
$
$ 18.84
$ 35.22
$ 23.44
$ 9.61
$ 1.38
$ 0.63
$ 0.22
$ 0.15
$ 0.01
$ 0.02
$
$ 35.46
$ 69.00
       Notes:    Detail may not be consistent with summary presentations due to independent statistical analysis.
BILLING CODE 6560-50-C
  Because the exact timing and
distribution of problems among systems
that may be identified by the sanitary
surveys is not known, an average annual
GWS cost of correcting significant
defects is calculated by summing the
cost of correcting all significant
deficiencies over the  25-year period of
analysis and apportioning them evenly
over the period during which they are
performed.
  For entry points with fecal indicator-
positive ground water source samples
(from triggered source water
monitoring), systems must perform
corrective action to comply with the
GWR. For cost estimation purposes, the
model assumes that for every source
water positive sample, at least one
additional sample will also be positive
(i.e., corrective action ultimately follows
every source water positive) (see
Chapter 6 of GWR EA (USEPA, 2006d)
for a complete discussion of this
assumption). For non-disinfecting
systems, the model assigns one
representative nontreatment corrective
action or one disinfection/treatment
corrective action (Table VII-10). The
cost model assigns nondisinfecting
entry  points that need to take corrective
actions to the treatment category using
the current proportion of all entry
points providing treatment for different
size categories. The current proportion
is a range of the estimated existing
percentages of treatment entry points
among the entry points with less than 4-
log disinfection and without
disinfection.
  For nontreatment corrective actions to
comply with the GWR, the cost model
assigns equal proportions of entry
points to high and low cost scenarios
and then assigns a representative
corrective action according to the
corresponding percentages in that
scenario. For entry points predicted to
use treatment corrective actions, the
cost model  assigns one of the possible
treatment technologies based on the
relative percentage of CWSs currently
engaged in  those treatment practices.
Finally, for entry points that require
corrective actions because of source
water fecal  contamination (from

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           Federal  Register/Vol.  71, No.  216/Wednesday, November 8, 2006/Rules and Regulations    65629
triggered source water monitoring) and
already disinfect, but the disinfection
does not achieve at least a 4-log
treatment of viruses before or at the first
customer, the compliance forecast
assigns a corrective action that either
increases the dose for hypochlorination
or chlorine gas or adds storage. More
information regarding the compliance
forecasts of corrective actions can be
found in Chapter 6 of the GWR EA
(USEPA, Z006d).
                               TABLE VI1-10.—REPRESENTATIVE CORRECTIVE ACTIONS
                                              Representative corrective actions
                                                         Note
For Significant Deficiencies at Source Identified
  by Sanitary Survey.

For Entry Points with a Fecal Indicator-Positive
  Ground Water Source Sample.
 Replace a Sanitary Well Seal ...
 Rehabilitate an Existing Well 	
 Non-Treatment Options 	
 Rehabilitate an Existing Well
 Drill a New Well
 Purchase Water
 Eliminate Source of Contamination
 Treatment Options 	
 Disinfection Alternatives or Nanofiltration
 Low cost option.

 High cost option.
 Interim disinfection is included for costing.
                                                                               Chlorine gas and hypochlorite will be  most
                                                                                 likely choices for large and  small systems,
                                                                                 respectively.
  In addition to the treatment technique
costs, EPA estimated the cost for
systems to conduct monitoring. It is
important to remember that triggered
source water monitoring applies only to
systems that do not achieve 4-log
treatment of viruses. Compliance
monitoring applies to systems that
currently provide 4-log treatment of
viruses, or those that install treatment as
a result of this rule. Assessment source
water monitoring is optional and is not
included in either the cost or benefit
estimates (see Section VII.J.10).
  The triggered source water monitoring
costs are calculated based on the cost of
the test and the operator's time to
collect and transport the sample. GWSs
have to collect a ground water source
sample and analyze it for the selected
indicator organism when the system
experiences a total coliform-positive
under the TCR. If the indicator sample
is positive, the system either takes five
additional samples or does corrective
action immediately. If any of the
additional samples is positive, the
system must implement a corrective
action. Specific issues regarding the
monitoring cost estimate are described
in Section VII.C.3 of this preamble. The
GWR EA has a more detailed discussion
of the monitoring cost analysis (USEPA,
2006d).
  The cost of compliance monitoring
varies with system size.  Compliance
monitoring is required for any system
that currently provides 4-log treatment
of viruses or installs treatment  as a
result of complying with this rule's
treatment technique requirements. EPA
assumes that systems with treatment
technology in place prior to the GWR
promulgation incur minimal additional
capital or operation and maintenance
(O&M) costs for compliance monitoring
because GWSs should already have a
monitoring program in place and has
not included them in the cost analysis.
However, the Agency does include costs
for systems to notify the State that they
achieve at least 4-log treatment of
viruses or to notify the State in case of
system failure.
  For those systems adding a
technology that provides 4-log treatment
of viruses as a corrective action for
source water fecal contamination, EPA
assumes that monitoring equipment will
also be installed to perform compliance
monitoring. The cost varies by system
size because the monitoring
requirements vary by size category. A
more detailed explanation of
compliance monitoring schemes is
discussed in Section IV.C.
  d. State costs. As indicated in Table
VII-6,  EPA estimates that States will
incur less than $11.8 million in
annualized costs due to the additional
sanitary survey requirements in this rule
(including increased frequency of
sanitary surveys), tracking monitoring
information, reviewing action plans,
data management, and other activities.
Along  with system costs, State costs are
also summarized in Table VII—8c.
  States will incur administrative costs
while implementing the GWR. These
implementation costs are not directly
required by specific provisions of GWR
alternatives, but are necessary for States
to ensure the provisions of the GWR are
properly carried out. States will also be
required to spend time responding to
PWSs whose ground water sources are
found to be fecally contaminated, or
have significant deficiencies. These
costs include time to review plans and
specifications, prepare violation letters,
and enter data. States will need to
allocate time for their staff to establish
and then maintain the programs
necessary to comply with the GWR,
including developing and adopting
State regulations, modifying data
management systems to track newly
required system reports to the States,
and providing ongoing technical
assistance to GWSs. For those GWR
requirements that include monitoring
with a laboratory method not currently
required by the State, the State must
devote a portion of its staff time to
certifying laboratories for the new
analytical method. Time requirements
for a variety of State agency activities
and responses are estimated in Chapter
6 of the GWR EA (USEPA, 2006d).
  In addition to these one-time costs,
States will  use resources to continue
activities for the implementation of the
GWR unrelated to any specific
provision. States with primacy
enforcement responsibilities have
recordkeeping (§ 142.14) and reporting
(§ 142.15) requirements associated with
primacy enforcement and must
coordinate  with EPA for review of the
State primacy program. States must also
continue to train their personnel and
PWS staff, maintain laboratory
certifications, and report system
compliance information to the Safe
Drinking Water Information System
(SDWIS).
3. Nonquantifiable Costs
  Although EPA has quantified the
significant costs of the GWR, there are
some costs  that the Agency did not
quantify. Overall, EPA  believes that
these nonqualified costs are much
smaller than the nonqualified benefits.
These nonqualified costs result from
uncertainties surrounding rule
assumptions and from modeling
assumptions. For example, EPA
estimated that some systems may need
to acquire land if they need to build a
treatment facility or drill a new well.
This was not considered for most
systems because EPA expects that the
majority of the technologies that

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65630   Federal Register/Vol. 71, No. 216/Wednesday,  November 8,  2006/Rules and  Regulations
systems will use to comply with this
rule will fit within the existing plant
footprint. In addition, if the cost of land
is prohibitive, a system may choose
another lower cost alternative such as
connecting to another source. EPA has
also not quantified costs for systems
already using disinfection to conduct
compliance monitoring because EPA
believes that such systems are already
incurring these costs.
  In addition, the optional assessment
source water monitoring provision was
not included in the quantitative cost
analysis. EPA was not able to quantify
either the benefits or costs of this
program. Because this provision could
potentially increase both benefits and
cost, a more complete discussion can be
found in Section VII.J of this preamble.
Due to lack of information, EPA was
unable to quantify the costs (as well as
benefits) from the correction of sanitary
survey deficiencies in distribution
systems and treatment plants. This is
discussed in Section VII.J of this
preamble.
  Also, the Agency did not include the
costs for taking five additional samples
following a positive source water
sample. However, EPA overestimated
the cost of triggered source water
monitoring because  it assumed all
systems would take  an additional
sample beyond the current TCR
requirements. However, many small
systems (and most GWSs are small) will
be able to use one of their TCR repeat
samples to also comply with the GWR.
Overall, the impact of not including the
five additional sample cost
(approximately $200,000 per year) is
much smaller compared to the
overestimate of a few million dollars
associated with the initial fecal
indicator sampling cost already
conducted for TCR monitoring.
4. How Have the Costs Changed Since
the Proposal?
  The estimated annual quantified costs
for the GWR have changed from $183
million and $199 million (year 2000
dollars at proposal, using three and
seven percent discount rates,
respectively) to $61.8 million and $62.3
million (year 2003 dollars, using three
and seven percent discount rates,
respectively). The change in quantified
costs is due to changes in both the
economic analysis estimates (e.g.,
interpretation of occurrence and other
data) and GWR provisions. However,
changes in the economic analysis
estimates are the dominant factor in
explaining the large change in costs
from the proposal. The major changes in
economic analysis estimates include the
following:
  • The number of significant
deficiencies  and corrective actions in
wells from sanitary survey provisions;
  • State costs for the incremental
changes to existing sanitary survey
programs;
  • The total coliform-positive samples
under the TCR and the number of
triggered source water monitoring
samples required under the GWR;
  • The frequency and duration of fecal
indicator occurrence in wells;
  • The efficiency by which fecally
contaminated wells are identified and
therefore performing a corrective action;
  • Compliance forecasts include a
higher percentage of non-treatment
corrective actions; and
  • Using net present values and then
annualizing  costs.
  EPA believes that the changes made
in the GWR EA since proposal
substantially improve the basis for
quantifying the GWR costs with more
available data, a major issue raised by
public comments (see Section VII.L of
this preamble for further discussion of
major public comments).
  Changes in the rule provisions also
impacted the final cost estimate but
these changes are not as significant as
the changes  made in the economic
analysis. In addition, the costs (as well
as benefits) for optional assessment
source water monitoring and additional
fecal indicator sampling following
triggered source water monitoring are
not included in the final rule analysis.
These potential impacts are discussed in
Section VII.J,
  Another major change in the
Economic Analysis since the proposed
GWR is a more thorough analysis of the
nonquantified costs. Chapter 6 of the
GWR EA describes the basis for the
analysis (USEPA, 2006d). Rule changes
can be found in Section VILA of this
preamble.

E. What Is the Potential Impact of the
GWR on Households?

  This analysis considers the potential
increase in a household's water bill if a
CWS passed the entire cost increase
resulting from this 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.
  The household cost analysis only
considers the impact on CWSs. State
costs and costs to TNCWSs and
NTNCWSs are not included in this
analysis since their costs are not passed
through directly to households. Table
VII-11 presents the mean expected
increases in annual household costs for
all CWSs, including those systems that
do not have to take corrective action for
significant  deficiencies or source water
fecal contamination. Table VII-11 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.
  As shown in Table VII-11, the mean
annual household costs for systems
(including those that do not add
treatment) range from $0.21 to $16.54
(systems serving fewer households
generally have higher average annual
household  costs). Household costs for
the subset of systems that take
corrective actions range from $0.45 to
$52.38. EPA estimates that, as a whole,
households subject to the GWR face
minimal increases in their annual costs.
The lowest increases in household costs
are for those served by larger systems
due to significant economies of scale
and because many already disinfect.
Approximately 66 percent of the
households potentially affected by the
GWR are customers of systems that
serve at least 10,000 people. Households
served by small systems that take
corrective actions will face the greatest
increases in annual costs.

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           Federal Register/Vol. 71, No. 216/Wednesday, November  8, 2006/Rules and Regulations   65631

           Table VII-11: Summary of Annual Per-Household Costs for the GWR (2003$/Year)
Systems Size
(Population
Served)
Households
Mean
Median
90th
Percentile
All Community Water Systems (CWSs)
<100
101-500
501-1,000
1,001-3,300
3.301-10K
1 0,001 -50K
50.001-100K
>100.000
289,222
1 ,303,890
1,278,081
4,196,105
6,271,380
11,468,813
4,204,584
9,755,817
$ - 16.54
$ 3.51
$ 0.97
$ 0.37
$ 0.27
$ 0.21
$ 0.34
$ 0.21
$ 2.81
$ 0.64
$ 0.16
$ 0.04
$ 0.03
$ 0.04
$ 0.10
$ 0.04
$ 9.31
$ 6.11
$ 1.70
$ 0.61
$ 0.43
$ 0.49
$ 1.02
$ 0.62
Corrective Action Community Water Systems (CWSs)
<100
101-500
501-1,000
1,001-3,300
3.301-10K
1 0,001 -50K
50.001-100K
>1 00,000
70,563
312.484
302.557
919,133
1,487,159
2,871,250
1,215,544
2,283,144
$ 52.38
$ 12.00
$ 3.23
$ 1.33
$ 0.80
$ 0.45
$ 0.53
$ 0.68
$ 18.99
$ 4.52
$ 1.33
$ 0.47
$ 0.25
$ 0.18
$ 0.26
$ 0.39
$ 82.21
$ 25.76
$ 6.56
$ 2.59
$ 2.18
$ 1.18
$ 1.36
$ 1.65
                            Source:  GWR model output.
F. What Are the Incremental Costs and
Benefits of the GWR?
  The GWR regulatory alternatives
achieve increasing levels of benefits at
increasing levels of costs. The regulatory
alternatives  for this rule, in rank order
of increasing costs and benefits are as
follows:
  • Alternative 1: Sanitary Survey and
Corrective Action.
  • Alternative 2: Risk-Targeted
Approach.
  • Alternative 3: Multi-Barrier
Approach.
  • Alternative 4: Across-the-Board
Disinfection.
  More information about the
alternatives  is provided in the GWR EA
(USEPA, 2006d).
  Incremental  costs and benefits are
those that are incurred or realized in
reducing viral illnesses and deaths from
one alternative to the next more
stringent alternative. Estimates of
incremental costs and benefits are
useful in considering the economic
efficiency of different regulatory
alternatives  considered by the Agency.
Generally, the goal of an incremental
analysis is to identify the regulatory
alternatives where net social benefits are
maximized. However, the usefulness of
this analysis is constrained when major
benefits and/or costs are not quantified
or not monetized as in the case with the
GWR. Also, as pointed out by the
Environmental Economics Advisory
Committee of the Science Advisory
Board, efficiency is not the only
appropriate criterion for social
decisionmaking (USEPA, 2000d).
  For the GWR, presentation of
incremental quantitative benefit and
cost comparisons may be
unrepresentative of the true net benefits
of the rule because a significant portion
of the rule's potential benefits are not
quantified, particularly bacterial illness
and deaths (see Section VII.C.4).
  Table VII-12a and Table VII-12b
present the four regulatory alternatives
in order of increasing level of reduction
in waterborne pathogens or increasing
level of protection from illness. All
values are annualized mean present
values expressed in year 2003 dollars.
The lower and upper bounds of a 90
percent confidence interval are shown
below the mean numbers. As shown in
Tables VII-12a and b, incremental net
benefits for all alternatives are negative.
The nonquantified bacterial illness
benefits would add benefits to all
alternatives without any increase in
costs. EPA estimated that the total
benefits could increase by more than a
factor of five by accounting for
additional deaths and hospitalizations
caused by reduced bacterial illness
alone. These nonquantified benefits
have a significant positive impact on the
incremental benefits and incremental
net benefits. Both Alternative 3 and
Alternative 2  could have positive
incremental net benefits if the bacterial
benefits are considered. The next
highest alternative, Alternative 4, has
such highly negative incremental net
benefits, and the difference is so
substantial, that nonquantified  benefits
would be unlikely to compensate.
However,  comparisons between
Alternative 4  and the other alternatives
may be between two separate sets of
benefits, in the sense that they may be
distributed to somewhat different
populations.

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TABLE Vll-I2a.— INCREMENTAL NET BENEFITS BY RULE ALTERNATIVE— ENHANCED COI
[Annualized Present Value Mean, $Millions, 2003$]
Rule alternatives
Annual quantified costs
A
Annual quantified bene-
fits (enhanced COI)
B
Incremental
costs
C
Incremental
benefits*
D
Incremental
net benefits*
E = D-C
Three Percent Discount Rate
(in dollars)
Alternative 1' Sanitary Survey and Corrective Action . 	 	
Final Rule' Risk-targeted Approach** ... 	 	
Alternative 3' Multi-Barrier Approach
Alternative 4' Across-the-Board Disinfection

15.3 (11.8-19.2)
61.8 (45.2-81.4)
67.9 (49.4-89.5)
686.4 (636.8-735.4)
3.6 (0.9-9.3)
19.7(6.5-45.4)
21.3(7.1-48.7)
70.2(18.3-177.0)
15.3
46.5
6.1
618.5
3.6
16.1
1.6
48.9
-11.7
-30.4
-4.5
-569.6
Seven Percent Discount Rate
(in dollars)
Alternative 1 • Sanitary Survey and Corrective Action
Final Rule' Risk-targeted Approach**
Alternative 31 Multi-Barrier Approach
Alternative 4: Across-the-Board Disinfection 	
15.3 (11.9-19.0)
62.3(46.1-81.6)
69.4(51.0-90.6)
665.3 (612.3-717.0)
2.9 (0.7-7.5)
16.8(5.5-38.6)
18.2 (6.0-41.6)
61.9 (16.1-156.3)
15.3
47.0
7.1
595.9
2.9
13.9
1.4
43.8
-12.4
-33.1
-5.7
-552.2
  *Does not include significant nonqualified benefits. See GWR EA Section 5.4 (USEPA, 2006d).
  "Benefits and costs are also not included for optional assessment source water monitoring.
                                    TABLE Vll-I2b.—INCREMENTAL NET BENEFITS BY RULE ALTERNATIVE—TRADITIONAL COI
                                                            [Annualized Present Value Mean, SMillions, 2003$]
Rule alternatives
Annual quantified costs
A
Annual quantified bene-
fits (traditional COI)
B
Incremental
costs
C
Incremental
benefits*
D
Incremental
net benefits*
E = D-C
Three Percent Discount Rate
(in dollars)
Alternative 1' Sanitary Survey and Corrective Action
Final Rule' Risk-targeted Approach**
Alternative 3' Multi-Barrier Approach . 	 	
Alternative 4' Across-the-Board Disinfection 	

15.3 (11.8-19.2)
61.8(45.2-81.4)
67.9 (49.4-89.5)
686.4 (636.8-735.4)
1.9(0.3-5.5)
10.0(2.2-27.0)
10.8 (2.5-28.9)
35.5 (6.5-102.4)
15.3
46.5
6.1
618.5
1.9
8.2
0.8
24.7
-13.5
-38.3
-5.3
- 593.8
Seven Percent Discount Rate
(in dollars)
Alternative 1 ' Sanitary Survey and Corrective Action
Final Rule1 Risk-targeted Approach** 	
Alternative 3' Multi-Barrier Approch 	 	
Alternative 4: Across-the-Board Disinfection 	
15.3(11.9-19.0)
62.3(46.1-81.6)
69.4 (51.0-90.6)
665.3(612.3-717.0)
1.5(0.2-4.5)
8.6 (1.9-23.0)
9.3 (2.1-24.8)
31.5 (5.7-90.8)
15.3
47.0
7.1
595.9
1.5
7.1
0.7
22.2
-13.8
-39.9
-6.4
-573.7
  *Does not include significant nonquantified benefits. See GWR EA Section 5.4 (USEPA, 2006d).
  "Benefits and costs are also not included for optional assessment source water monitoring.
  Notes: The Traditional COI only includes valuation for medical costs and lost work time (including some portion of unpaid household production and caregiver time for sick children). The
Enhanced COI  also factors in  valuations for lost personal time (non-worktime) such as child care and homemaking (to the extent not covered by the traditional COI), time with family, and
recreation, and  lost productivity at work on days when workers are ill but go to work anyway.
  Source: Chapter 8 of the GWR EA (USEPA, 2006d). Ranges in parentheses are the 90 percent confidence bounds.

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           Federal  Register/Vol.  71, No. 216/Wednesday,  November 8,  2006/Rules and  Regulations    65633
G. Are There Any Benefits From
Simultaneous Reduction of Co-
Occurring Contaminants?

  As discussed in Section VII.B.2, the
GWR is expected to reduce not only
viral illnesses and deaths (the
monetized rule benefit) but also
bacterial illnesses and deaths. This rule
is also expected to decrease the risk of
outbreaks that would reduce illnesses
and deaths and other outbreak-related
costs. Additional health benefits of this
rule include the reduction in illnesses
and deaths associated with reduced
incidence of upsets or failures among
disinfecting supplies and reduced
incidence of distribution system
contamination among disinfecting and
non-disinfecting systems. EPA
anticipates reductions in disease
incidence in these areas to result from
the sanitary survey provisions and the
treatment and monitoring provisions
pertaining to  disinfected supplies.
  If a system  chooses to install
treatment, it may choose a technology
that would  also address other drinking
water contaminants. If a system had an
iron or manganese problem, for
example, the  addition of an oxidant and
filtration could treat this problem as
well as fecal contamination. Also, some
membrane technologies installed to
remove bacteria or viruses can reduce or
eliminate many other drinking water
contaminants, including arsenic. EPA
recognizes that some systems will
choose these  more expensive treatment
technologies. EPA has included them in
the decision tree in the cost analysis,
but no estimate of the additional benefit
from reducing co-occurring
contaminants has been made.

H. Is There Any Increase in Risk From
Other Contaminants?

  It is unlikely that the GWR will result
in a significant increase in risk from
other contaminants, although adding
disinfection to currently non-
disinfecting systems could result in
some increased risk. When disinfection
is first introduced into a previously
undisinfected system, the disinfectant
can react with pipe scale, causing
increased risk from some contaminants
and other water quality problems.
Contaminants that could be released
include lead,  copper, and arsenic. It
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.
  Using a chemical disinfectant could
also result in an increased risk from
disinfection byproducts (DBFs). Risk
from DBFs 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 recently
published final Stage 2 DBPR (USEPA,
2006g). In general, GWSs are less likely
to experience high levels of DBFs than
surface water systems because they have
lower levels of naturally occurring
organic materials (generally represented
by total organic carbon (TOG)) that
contribute to DBP formation. For the
most part, GWSs with high levels of
TOG in their ground water source are
located in States that already require
GWSs to disinfect, therefore decreasing
the chance that significant disinfection
byproduct problems would result from
this rule.

/. What Are the Effects of the
Contaminant on the General Population
and Groups Within the General
Population That Are Identified as Likely
To Be at Greater Risk of Adverse Health
Effects?
  EPA estimates that the average annual
baseline illnesses and deaths associated
with viruses in ground water are about
185,000 and 3, respectively (Table VII-
4). The general population typically
experiences GI illness when exposed to
waterborne viral and bacterial
pathogens, although other severe
diseases such as kidney failure can also
occur. Sensitive subpopulation
exposure to these pathogens can result
in more severe illness than in  the
general population, and sometimes
death.
  Examples of sensitive subpopulations
include pregnant women, infants,
elderly (over 65), cancer patients, and
AIDS patients (Gerba et al., 1996). Gerba
estimates  that these groups represent
almost 20 percent of the U.S.
population. The purpose of this section
is to discuss the potential health effects
associated with sensitive population
groups, especially children, pregnant
women, and the elderly.

1. Risk of Acute Viral Illness to Children
and Pregnant Women
  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 mellitis (CDC, 1997; Modlin,
1997; Melnick, 1996; Cherry, 1995;
Berlin et al., 1993; Smith,  1970; Dalldorf
and Melnick, 1965). 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, 2000e).
  a. Children's Environmental Health.
To  comply with  Executive Order 13045,
EPA calculated the baseline risk and
reduction of risk from waterborne viral
illness and death for children as a result
of this rule. To address the
disproportionate risk of waterborne viral
illness and death affecting children,
EPA used age-specific morbidity data in
the risk assessment. The risk assessment
first estimated the proportion of the
population that falls into several age
categories for which data are available
for  two model viruses: Type A
(represented by rotavirus data) and Type
B (represented by enterovirus or
echovirus data).
  While bacterial illnesses are not
addressed in the quantified benefits
analysis, EPA believes that the
nonquantified benefits associated with
consumption of undisinfected
bacterially contaminated PWS well
water could be significant  in sensitive
subpopulations.  In an alternative
analysis to the quantified benefits
calculation, EPA estimated that roughly
16,805 bacterial illnesses and 11
bacterial deaths annually could be
avoided in the general population. See
Section 5.4.3 of the GWR EA for details
of the analysis (USEPA, 2006d).
Children and the elderly are particularly
vulnerable to kidney failure (hemolytic
uremic syndrome) caused  by the
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).
  Type A viruses of high infectivity
(Type A, e.g., rotavirus)
disproportionately affect children less
than three years of age. Thus, the age
categories used in the hazard analysis
were less than three years of age and
greater than three years of  age. Based on
rotavirus data, it was assumed that 10 to

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65634    Federal Register/Vol.  71,  No. 216/Wednesday,  November 8, 2006/Rules and Regulations
88 percent of children less than three
years old would become ill once
infected with high infectivity viruses
and that 10 to 50 percent of the
population over three years of age
would become ill.
  For viruses of low-to-medium
infectivity (Type B, e.g., echovirus),
children are again disproportionately at
risk of becoming ill once infected. For
this virus  type, the age categories used
in the hazard analysis were less than
five years  of age, five to 19 years of age,
and greater than 19 years of age. Based
on echovirus data, EPA estimated that
50 to 78 percent of children less than
five years  old would become ill once
infected with low-to-medium infectivity
viruses, 12 to 57 percent of children five
to 19 years of age and 12 to 33 percent
of people  over 19 years of age would
become ill once infected.
  In addition to illness, EPA also
considered child mortality attributable
to waterborne viral illness. For viruses
of high infectivity (Type A), EPA
estimates  0.00057 to 0.00073 percent of
the ill population (including children)
will die (Tucker et al., 1998). This value,
based on rotavirus data from children
less than five years of age (20 deaths
from 2,730,000 to 3,500,000 illnesses),
was applied to individuals of all ages
because data for older individuals are
not available. For low-to-medium
infectivity viruses (Type B), EPA
estimates that 0.92 percent of children
less than one month of age who become
ill will die based on data from Jenista et
al. (1984), Modlin (1986) and Kaplan et
al. (1983). For those individuals greater
than one month in age, 0.02 percent
who become ill will die based on the
EPA assumption that one percent of
enterovirus illnesses are severe and two
percent of severe illnesses result in
death. The low-to-medium infectivity
viruses result in a higher mortality rate
than the high infectivity viruses because
they can cause more serious health
effects.
  To estimate the benefits to children
from this rule, the Agency calculated
the number of endemic, acute viral
illnesses and deaths avoided after rule
implementation for children less than
five years old and for children ages five
through 15 years old. Table VII-13
shows the estimates for annual illnesses
avoided in young children due to this
rule. Overall, this rule will result in
about 2,780 fewer endemic, acute viral
illnesses per year caused by Type A
(represented by rotavirus  data) and Type
B (represented by enterovirus or
echovirus data) viruses and 0.06 deaths
in children less than five years of age.
For older children aged five to 15 years
of age, this rule will result in 4,856
fewer acute illnesses per year (see
Chapter 5  of the GWR EA (USEPA,
2006d)). In addition to endemic, acute
viral illnesses avoided, EPA estimates
that there  will be  fewer deaths (less than
one death) in children of all ages.
  Of the total annual avoided
gastrointestinal illnesses predicted as
the result  of this rule, approximately 18
percent (7,636)  of the mean annual
illnesses avoided  occur in children aged
15 years or younger. Children are
disproportionately represented in the
average annual  number of illnesses
avoided. Because children are often
likely to be exposed via exposure
pathways  other than water in schools
and day care centers (including fomites,
respiratory, dermal, and person-to-
person), the waterborne proportion
probably does not dominate in total
exposure but it  may represent a
significant fraction. More serious
waterborne illnesses, such as hemolytic
uremic syndrome (kidney failure),
disproportionately affect children but
this calculation only considers
gastrointestinal illness.
         TABLE VII-13.—ANNUAL VIRAL ILLNESSES AVOIDED BY THE GWR IN CHILDREN, THE ELDERLY, AND THE
                                                IMMUNOCOMPROMISED
Virus type
Type A (Rotavirus)
Type B (Enterovirus or Echovirus)

Health
effect
Illness ...
Death ...
Illness
Death ...
Infants and
young children
<5 years old
2,588
0.02
191
0.04
Elderly adults >65
years old
Illness: 5,559 	
Deaths' 010

Immunocompromised
(all ages)
Illness' 126 .
Deaths' 0 002

Total sensitive
subgroups
Illness- 8 465
Deaths' 015

  Note: Detail may not sum due to independent statistical analyses and rounding. The figures presented represent only the quantifiable benefits
of the GWR. The nonquantified benefits are expected to comprise a significant portion of the overall benefits of the GWR  and are presented in
Section 5.4 of the GWR  EA (USEPA, 2006d). The immunocompromised population includes bone marrow transplant recipients, AIDS patients,
and organ transplant patients.
  Source: Number of Illnesses Avoided, Deaths Avoided, and Annual Benefits from GWR Model Output.
2. Risk of Viral Illness to the Elderly and
Immunocompromised
  The elderly are particularly at risk
from diarrheal diseases (Glass et al.,
2000), such as those associated with
waterborne microbial pathogens. Fifty-
three 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 GWS resulted in four
deaths, all among the elderly. One death
occurred from hemolytic uremic
syndrome (kidney failure); the others
from gastrointestinal illness. Table VII-
13 shows that this rule's estimates for
avoided viral illnesses and deaths per
year in the elderly population (> 65
years old) are approximately 5,559 and
0.1, respectively.
  Most epidemiological studies focus on
nursing homes because the cluster of
individuals improves data collection.
Nursing home populations are typically,
but not exclusively, elderly. Gerba et al.
(1996) compiled data to show that, for
the various waterborne microbial
pathogens, nursing home mortality rates
are significantly higher than in the
general population. In Gideon, Missouri,
a waterborne Salmonella typhimurium
outbreak (Angulo et al., 1997) resulted
in seven deaths from gastrointestinal
illness, all among nursing home
residents.
  Hospitalizations due to diarrheal
disease are higher in the elderly (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).
  For another significant sensitive
subpopulation, the
immunocompromised, Gerba et al.
(1996) summarized 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

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           Federal  Register/Vol.  71,  No.  216/Wednesday, November 8, 2006/Rules and Regulations    65635
studies cited by Gerba et al. (1996)
reported mortality rates greater than 50
percent among patients infected with
enteric viruses. Table VII-13 shows that
this rule's estimates for avoided
illnesses and deaths in the
immunocompromised groups (all ages)
are approximately 126 and 0.002,
respectively.
  Overall, this rule will provide
protection from waterborne viral and
bacterial illness to both the general
population and sensitive
subpopulations. To capture the impact
of the rule on both populations, the
Agency considered the different
severities of illness when valuing
reductions in illness that will result
from this rule.
/. What Are the Uncertainties in the
Risk, Benefit, and Cost Estimates for the
GWR?
  Many uncertain values are used to
derive estimates of baseline risk, risk
reductions, and costs of this rule. Most,
but not all, of these are mathematically
modeled so that a "realization" is
selected  for them in each "uncertainty
iteration" of EPA's probabilistic
economic analysis. These uncertainties
then propagate through the derivation of
final estimates so the total uncertainty
of those final estimates can be
understood. Each of those uncertainties,
or the assumption that is made by not
modeling it mathematically, is
summarized in Sections 5.6 (for
benefits) and 6.7 (for costs) in the GWR
EA (USEPA, 2006d) for its importance
and tendency to contribute
systematically to an over-or
understatement of the final estimate.
The paragraphs that follow discuss the
most important of these uncertain
quantities.
1. The Baseline Numbers of Ground
Water Systems, Populations Served, and
Associated Disinfection Practice
  The baseline number of systems is
uncertain because of data limitations in
the Safe Drinking Water Information
System (SDWIS). For example, some
systems use both ground and surface
water, but because of other regulatory
requirements,  they are labeled in SDWIS
as surface water systems. In addition,
the SDWIS data on NCWSs do not
reflect a consistent reporting convention
for population served. Some States may
report the population served by
TNCWSs over the course of a year,
while others may report the population
served on an average day. For example,
a State park may report the population
served yearly instead of daily. Thus,
SDWIS data may, in some cases,
overestimate the daily population
served. Also, SDWIS does not require
States to provide information on current
disinfection practices, resulting in
uncertainty in the percentage of
disinfecting systems providing 4-log or
greater virus treatment. Although these
different factors influencing the baseline
estimates are uncertain, EPA believes
that their relative degree of uncertainty
in influencing the estimates within the
GWR EA is small compared to other
uncertain components of the Economic
Analysis, so these are not treated
probabilistically in the analysis.

2. The Numbers of Wells Designated as
More Versus Less Vulnerable

  For the purposes of the GWR EA,
contaminated wells are classified as
more or less vulnerable, which
determines the assumptions used for the
concentrations of virus as discussed in
Section VII.B.l.c of this preamble. The
numbers of systems falling into these
two categories is uncertain and is also
modeled as an uncertain variable.

3. The Baseline Occurrence of Viruses
and E. coli in Ground  Water Wells

  EPA's occurrence analysis is based on
monitoring data from  over 1,200  public
drinking water supply wells that were
tested for culturable virus, E. coli, or
both. Compiled from 15 ground water
surveys that were designed for different
purposes, these wells  are believed to be
representative of ground water wells.
Although the number of wells is  large,
the number of assays per well is small,
and most wells were sampled only once
for either virus or E. coli. Because of the
limited amount of data, these data do
not provide precise occurrence
estimates. EPA's analysis recognizes the
limitations of the data, producing a large
"uncertainty sample" of estimates that
are consistent with the data. This
uncertainty sample is  an input to the
probabilistic economic analysis, where
these uncertainties are combined with
the uncertainties of other inputs to
portray total uncertainty in the GWR
cost and benefit estimates. EPA's
occurrence model includes
concentration differences between more
and less vulnerable wells, but applies
the same hit rate model to both types of
wells. Also, because of data limitations,
EPA was unable to make an assessment
of aquifer sensitivity as part of the final
rule and, therefore, no difference in hit
rates or concentration levels between
sensitive and nonsensitive wells  is
assumed. The GWR EA addresses
uncertainty about these assumptions in
a qualitative discussion (USEPA,
2006d).
4. For the Sanitary Survey Provisions,
the Percentage of Systems Identified as
Having Significant Deficiencies, the
Percentage of These Deficiencies That
Are Corrected, and State Costs for
Conducting Surveys

   For the sanitary survey provisions,
EPA estimated the impacts associated
with well deficiencies. EPA used data
from the 1998 ASDWA survey to
estimate the percentage of wells with
deficiencies (ASDWA, 1997). To
estimate benefits, EPA assumed that if a
correction of a well defect occurred at
a virally contaminated well, some, but
not all of these virally contaminated
wells would no longer have viral
contamination. EPA used an uncertainty
distribution for this estimate.
   To estimate costs for significant
deficiencies detected at or near the
source, EPA chose two representative
corrective actions to use in the cost
model: replacement of a sanitary well
seal or rehabilitation of an existing well.
Because  the corrections of significant
deficiencies are dependent upon the
deficiencies defined as significant by
States and the conditions of specific
systems, both of which are highly
variable, EPA used a high and low
scenario to bound the cost estimates.
The low-cost scenario assumes a greater
percentage of the systems with
significant deficiencies will have
deficiencies that are less expensive to
correct (e.g., more systems will have to
replace their sanitary well seal than will
have to perform a complete
rehabilitation of their well). This high/
low bounding provides an estimate of
the uncertainty with respect to the
percentages of each type of defect to be
corrected.
  While  the sanitary survey provisions
will also result in identification and
correction for deficiencies associated
with treatment or distribution system
deficiencies,  due to insufficient data,
EPA did  not quantify either costs or
benefits for these types of deficiencies.
In the GWR EA, EPA qualitatively
discusses these impacts (USEPA,
2006d).
  Finally, EPA assumes that most States
are already conducting sanitary surveys
that include the eight required elements,
and that  many States are already
conducting sanitary surveys for GWSs
that meet the frequency requirements in
the GWR, so EPA estimated incremental
costs for  these activities in only a
relatively small subset of States.

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65636    Federal Register/Vol. 71, No.  216/Wednesday, November  8, 2006/Rules and Regulations
5. The Predicted Rates at Which Virally
Contaminated (and Non-Contaminated)
Wells Will Be Required To Take Action
After Finding E. coli Ground Water
Sources
  EPA's occurrence model estimates the
percentage of wells that have only virus
present, both E. coli and virus present,
or only E. coli present. The occurrence
model also includes parameters that
describe how often contaminated wells
actually have the contaminant present.
For example, some contaminated wells
have E. coli present less than one
percent of the time, while others have
E. coli present more than 10 percent of
the time (some of which will also have
sometime viral presence). When E. coy/-
contaminated wells are tested for the
first time, those with frequent E. coli
occurrence are the most likely to be
identified as contaminated. As these
problems are addressed and corrected,
there should be fewer and fewer wells
with frequent E. coli occurrence (as well
as viral occurrence since a fraction of E.
coli wells will also have sometime viral
presence; see Section III.C.2 for further
elaboration). This diminishing rate of
fecal contamination identification is
included in the GWR EA (USEPA,
2006d). Uncertainty about the
diminishing rate is due to uncertainty
about the EPA's estimates of how often
E. coli occurs in contaminated wells. As
with other key uncertain inputs, this
uncertainty is represented by an
uncertainty sample of the relevant
parameters. Again, EPA assumes no
difference based on vulnerability or
sensitivity. The GWR EA qualitatively
discusses uncertainty of this assumption
(USEPA, 2006d).
  Undisinfected wells are subjected to
triggered source water monitoring. The
rate at which triggered source water
monitoring identifies a well as fecally-
contaminated depends on both the
fraction of time that E. coli is present in
the well and the frequency at which the
well is sampled. Data verification  (DV)
data on total coliform occurrence in
distribution systems provide the basis
for estimates of sampling frequency in
different types and sizes of systems.
Although the data are limited, EPA has
not modeled these as uncertain
estimates. Compared to other uncertain
parameters, these have relatively little
uncertainty and are expected to make
only minor contributions to the total
uncertainty in the GWR EA.
  EPA also did not consider the cost
impacts of additional fecal indicator
sampling following triggered source
water monitoring on corrective action
costs. The analysis assumes that for
every triggered source water monitoring
positive, at least one additional fecal
indicator sample will also be positive,
resulting in corrective action. The
rationale for this assumption is
explained in Chapter 6 of the GWR EA.
However, it is possible that some
systems will not have a positive
additional fecal indicator sample and
will therefore not incur costs for
corrective action. Accounting for this
would reduce the costs of the rule
associated with corrective actions and,
to the extent that these systems actually
do have viral or bacterial pathogens
present, would reduce the benefits of
the rule as well.
  EPA assumes that the occurrence of
fecal contamination will remain
constant throughout the  implementation
of the rule. However, this might not be
the case if increased development
results in fecal contamination of a larger
number of aquifers in areas served by
GWSs or if other rules, such as
Concentrated Animal Feeding
Operations (CAFO) and Class V
Underground Injections  Control (UIC)
Well regulations, result in decreased
fecal contamination. This uncertainty is
not mathematically  modeled in the
GWR Economic Analysis.

6. The Infectivity of Echovirus  and
Rotavirus Used To Represent Viruses
That Occur in Ground Water

  EPA does not have dose-response data
for all viruses associated with previous
ground water disease outbreaks. For
viral illness, the Agency used echovirus
and rotavirus as surrogates for all
pathogenic viruses from fecal
contamination that can be found in
ground water. By using these two
viruses, the Agency is capturing the
effects of both high infectivity (Type A)
viruses that cause mild illness  and low-
to-medium infectivity (Type B) viruses
that may cause more severe illness but
not the range of infectivity within each
type.  Further, there  is additional
uncertainty in the dose-response
functions used, even for these two
viruses. The dose-response relationship
was modeled in two steps. First,
infectivity, or the percentage of people
in the different age groups who become
infected after exposure to a given
quantity of water with a given
concentration of viruses, was estimated.
Then morbidity, or the percentage of
infected people who actually become ill,
was estimated. EPA models uncertainty
for morbidity within different age
categories and differences in morbidity
across different age  categories
(variability).
7. The Costs of Illnesses Due to
Ingestion of Contaminated Ground
Water

  There is also uncertainty in the
valuation of risk reduction benefits. For
this analysis, EPA used a cost of illness
(COI) approach based on the direct
medical care costs as well as the
indirect costs of becoming ill. However,
there is uncertainty in these estimates
and variability in the COI across
populations and geographic regions.
8. The Costs of Taking Action After
Finding E. coli in Ground Water Sources

  EPA recognizes that there are both
variability and uncertainty in unit cost
estimates for treatment. Variability is
expected in the actual costs that will be
experienced by different water systems
with similar flows installing the same
treatment technology. Otherwise similar
systems may experience different
capital and/or O&M costs due to site-
specific factors. Inputs to unit costs
such as water quality conditions, labor
rates, and land costs can be highly
variable and increase the system-to-
system variability in unit costs. In
developing the unit cost estimates, there
is insufficient information to fully
characterize what the distribution of
this variability will be on a national
scale for all of the treatments and all
possible conditions.
  The unit costs for the GWR EA are
developed as average or representative
estimates of what these unit costs will
be nationally. That is, in developing
unit costs, design criteria for the
technologies were selected to represent
typical, or average, conditions for the
universe of systems. As  a result, there is
uncertainty inherent in these unit cost
estimates since they are based on
independent assumptions with
supporting data and vendor quotes,
where available, rather than on  a
detailed aggregation of State, regional,
or local estimates based on actual field
conditions. EPA quantifies the
uncertainty in these national average
unit cost factors  for specific
technologies. The percentage
uncertainty bounds used to characterize
unit costs were developed based on
input from engineering professionals
and reflect recommendations from the
National Drinking Water Advisory
Council (NOWAC, 2001) in its review of
the national cost estimation
methodology for the Arsenic Rule. EPA
believes that the uncertainties in capital
and O&M costs for a given treatment
technology are independent of one
another and that uncertainties across all
technologies  are independent.

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           Federal Register/Vol. 71, No.  216/Wednesday, November  8, 2006/Rules and Regulations    65637
9. Nonquantifiable Benefits
  A major uncertainty concerns the
number of baseline bacterial illnesses
caused by ground water contamination.
The bacterial risk could not be modeled
because of the lack of occurrence and
dose-response data; therefore, the
Agency was unable to include these
benefits in the primary  analysis. Many
other nonquantifiable endpoints (as
discussed in Section VII.C.4 of this
preamble and in the GWR EA Chapter
5 (USEPA, 2006d) cause further
uncertainty. In summary, the quantified
benefits may be small as compared with
the total benefits. EPA's analysis of
benefits from avoided bacterial illnesses
and deaths suggests that these benefits
could exceed the monetized benefits by
a factor of five.

10.  Optional Assessment Source Water
Monitoring
  The Agency was not able  to estimate
the benefits or costs resulting from the
optional assessment source  water
monitoring program.  States  can
determine which systems they deem
most vulnerable to fecal contamination
and require these systems to conduct
assessment source water monitoring.
Systems would incur additional costs
from monitoring and reporting results as
well as any corrective action associated
with fecal indicator-positives. States
would incur additional costs for
determining what systems would be
required to monitor, assisting  systems
with corrective action decisions, and
recordkeeping. The types of illnesses
avoided would be similar to those
already described in this preamble such
as reduced viral and bacterial  illness.

11.  Corrective Actions and Significant
Deficiencies
  The Agency also did not develop
costs for corrective actions for all
conceivable significant deficiencies that
a system may encounter. Instead,
representative actions that span the
range of low cost to expensive actions
were used as shown in Table VII—10.
The corrective actions that are a result
of significant deficiencies identified
during sanitary surveys do not include
the ones performed within the treatment
plant or in the distribution system due
to lack of adequate data. Exclusion of
these costs from the cost analysis results
in an  underestimate of potential rule
costs, though the magnitude of the
underestimate is unknown. Data
limitations also exclude quantifying any
benefits that may be realized from these
corrective actions. More information
regarding these costs and benefits can be
found in the GWR EA (USEPA, 2006d)
(see Chapter 6.6 for cost and Chapter
5.4.7 and 5.4.8 for benefits).

12.  Uncertainty Summary
  Overall, EPA recognizes that there is
uncertainty in  various parts of its
estimates. The Agency has, however,
been careful to use the best available
data to account for uncertainty
quantitatively when possible, and to
avoid any consistent biases in
assumptions and the use of data. The
primary known bias is that some
benefits and costs have not been
quantified, and therefore are not
included in the quantitative comparison
of regulatory alternatives. However, as
explained above and in the EA, EPA
believes that the nonquantified benefits
are  significantly greater than the
quantified benefits. In summary, EPA
believes that the analyses presented
represent a solid foundation for the
decisions made for this rule.
K. What Is the Benefit/Cost
Determination for the GWR?
  As required by the SDWA, at the time
of proposal, the Agency determined that
the benefits of this rule justify the costs.
In making this determination, EPA
considered both 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.
  For the final rule, as shown in Table
VII—14, for the regulatory alternative
being finalized in this rule, the
annualized mean  quantified benefits are
approximately $20 million ($10 million
using traditional cost-of-illness values)
and the annualized mean quantified
costs are approximately $62 million
using a three percent discount rate ($17/
$9 million and $62 million,
respectively, using a seven percent
discount rate). Overall, the GWR will
reduce the risk of fecal contamination
reaching the consumer. The monetized
costs of these provisions were compared
to the monetized benefits that result
from the reduction in some viral
illnesses and deaths. In addition, other
non-monetized benefits further justify
the costs of this rule. For example,
including bacterial illness would
significantly increase the benefits
without any increases in costs.
  Table VII-15 shows the net benefits
for this rule as well as the three
regulatory alternatives considered. The
net benefits include only the monetized
values (i.e., nonquantified costs and
benefits are not considered). The
nonquantified benefits are likely to be
significantly greater than the quantified
benefits (and also  much greater that the
nonquantified costs). Thus, the net
benefits of each of the options may be
higher than shown in these estimates.
Nonquantified costs are also not
included.
               TABLE Vll-14.—ESTIMATED ANNUALIZED NATIONAL BENEFITS AND COSTS FOR THE GWR
                                                   [SMiliions, 2003$]

Enhanced COI:
Benefits 	 	
Costs
Net Benefits . 	
Traditional COI:
Benefits
Costs 	 	
Net Benefits 	
Nonquantified Benefits 	

3% Discount rate
Mean
$19.7
61.8
-42.1
10.0
61.8
-51.8
Decreased incid
Decreased incid
Decreased incid
90 percent confidence bound
Lower
(5th %ile)
$6.5
45.2
Note 1
2.2
45.2
Note 1
ence of other acu
ence of bacterial
ence of chronic b
Upper
(95th %ile)
$45.4
81.4
Note 1
27.0
81.4
Note 1
te viral disease e
llness and death
acterial or viral ill
7% Discount rate
Mean
$16.8
62.3
455
8.6
62.3
-53.7
ndpoints.
less sequellae.
90 percent confidence bound
Lower
(5th %ile)
$5.5
46.1
Note 1
1.9
46.1
Note 1
Upper
(95th %ile)
$38.6
81.6
Note 1
22.9
81.6
Note 1

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65638    Federal Register/Vol. 71, No.  216/Wednesday, November  8,  2006/Rules and  Regulations
          TABLE VI1-14.—ESTIMATED ANNUALIZED NATIONAL BENEFITS AND COSTS  FOR THE GWR—Continued
                                                        [SMillions, 2003$]

3% Discount rate
Mean
90 percent confidence bound
Lower
(5th %ile)
Upper
(95th %ile)
7% Discount rate
Mean
90 percent confidence bound
Lower
(5th %ile)
Upper
(95th %ile)
                                       Decreased incidence of waterborne disease outbreaks and epidemic illness.
                                       Decreased illness through minimizing treatment failures or fewer episodes with inadequate treatment.
                                       Potential decreased use of bottled water and point-of-use devices (material costs).
                                       Decreased time spent on averting behavior.
                                       Avoided costs associated with outbreak response.
                                       Perceived improvement in drinking water quality and reduction in risk associated with ingestion.
                                       Benefits from optional Assessment Source Water Monitoring.
                                       Benefits from correction of sanitary survey deficiencies identified in the distribution systems and
                                       treatment plant.
    Nonquantified Costs
Costs for optional Assessment Source Water Monitoring.
Costs from correction of sanitary survey deficiencies identified in the distribution systems and
treatment plant.
Some land costs depending on the treatment technology.
Cost for five additional samples  but this  is small compared to the overestimate of cost for the initial
fecal-indicator sample that systems would take.
Costs for compliance monitoring at some systems that already disinfect.
  Note 1:  Because benefits and costs are calculated using different model modules, bounds are not calculated on net benefits.
  Note 2:  The Traditional COI only includes valuation for medical costs and lost work time (including some portion of unpaid household produc-
tion). The  Enhanced COI also factors in valuations for lost personal time (non-worktime) such as child care and homemaking (to the extent not
covered by the traditional COI),  time with family, and  recreation, and lost productivity at work on days when workers are ill but  go to work
anyway.

              TABLE VII-15.—ANNUALIZED NET BENEFITS ($MILLIONS, 2003$) BY REGULATORY ALTERNATIVE
              Rule alternative
                                                                              Annualized value
                                                         3% discount rate
                                                             (dollars)
                                                              7% discount rate
                                                                 (dollars)
Enhanced COI:
    Alternative 1 	
    Final Rule 	
    Alternative 3 	
    Alternative 4 	
Traditional COI:
    Alternative 1 	
    Final Rule 	
    Alternative 3 	
    Alternative 4 	
    Nonquantified Benefits
                                         -11.7
                                         -42.1
                                         -46.6
                                        -616.2
 -12.4
 -45.5
 -51.2
-603.4
    Nonquantified Costs
                                         -13.5                                      -13.8
                                         -51.8                                      -53.7
                                         -57.1                                      -60.1
                                        -650.9                                     -633.8
     Decreased incidence of other acute viral disease endpoints.
     Decreased incidence of bacterial illness and death.
     Decreased incidence of chronic bacterial or viral illness sequellae.
     Decreased incidence of waterborne disease outbreaks and epidemic illness.
     Decreased illness through minimizing treatment failures or fewer episodes with inadequate
     treatment.
     Potential decreased use of bottled water and point-of-use devices (material costs).
     Decreased time spent on averting behavior.
     Avoided costs associated with outbreak response.
     Perceived improvement in drinking water quality and reduction in risk associated with ingestion.
     Benefits from optional Assessment Source Water Monitoring.
     Benefits from correction of sanitary survey deficiencies identified in the distribution systems and
     treatment plant.
     Costs for optional Assessment Source Water Monitoring.
     Costs from correction of sanitary survey deficiencies identified in the distribution systems and
     treatment plant.
     Some land costs depending on the treatment technology.
     Cost for five additional samples but this is small compared  to the overestimate of cost for the
     initial fecal-indicator sample that systems would take.
     Cost for compliance monitoring at some systems that already disinfect.

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           Federal
Register/Vol.  71,  No. 216/Wednesday, November  8, 2006/Rules and Regulations
                              65639
  In addition to examining the net
benefits of this rule, the Agency used
several other techniques to compare
benefits and costs. For example, Table
VII—16 shows the cost of the rule per
viral illness avoided. This cost
effectiveness measure is another way of
examining the benefits and costs of the
                    rule but should not be used to compare
                    alternatives because an alternative with
                    the lowest cost per illness avoided may
                    not result in the greatest net benefits.
                    The cost effectiveness analysis, as with
                    the net benefits, is limited because the
                    Agency was able to only partially
                    quantify and monetize the benefits of
the GWR. This rule achieves the lowest
cost per viral illness avoided.
Additional information about this
analysis and other methods used to
compare benefits and costs can be found
in Chapter  8 of the GWR EA (USEPA,
2006d).
         TABLE VII-16.—COST PER CASE OF VIRAL ILLNESS OR DEATH AVOIDED BY REGULATORY ALTERNATIVE
                                                      [2003S]

Rule alternative
Alternative 1
Final Rule . ....
Alternative 3 	 	 	 	 	 	 	
Alternative 4 	
Cost per viral i
3%
(dollars)
2 045
1 476
1,495
4.420
Iness avoided
7%
(dollars)
2044
1 488
1 527
4.284
  Note: Calculated using mean costs of illness avoided.
  Overall, the measures described above
are very close for the Final Rule and
Alternative 3 and EPA believes that the
nonquantified benefits of the rule would
result in positive net benefits for either
option. The Final Rule allows States to
implement the assessment source water
monitoring provision, which would
have been mandatory if EPA had chosen
Alternative 3, on a voluntary basis. The
final GWR is more flexible, targeted, and
protective than Alternative 3 (see
Section VILA of this preamble and
Chapter 8 of the GWR EA (USEPA,
2006d) for more details). The level at
which additional costs will be incurred
and benefits realized under the
voluntary provision is dependent on the
rate at which States elect to adopt the
provisions, and thus is not quantified as
part of the Economic Analysis.

L. What Were Some of the Major
Comments Received on the Economic
Analysis and What Are EPA's
Responses?

I. Costs
  EPA requested comment on all
aspects of cost analysis for the proposed
GWR, particularly on the flow estimate
for NTNCWSs and TNCWSs and
handling mixed systems. In addition to
these two issues, EPA also received
numerous comments on the following
analyses: sanitary survey costs, estimate
of treatment baseline, costs of corrective
actions, and compliance costs for small
systems or NCWSs.
  a. Flow estimate for NTNCWSs and
TNCWSs. EPA received a few comments
on NTNCWS and TNCWS flow
estimates. Some commenters indicated
that the alternative approach described
in the preamble of the proposed rule
would lead to greater disparities from
                   the true values. The other commenters
                   supported using the alternative
                   approach. For this rule, EPA continues
                   to apply the CWS regression equations
                   to NCWSs, recognizing that this may
                   overestimate flow and, therefore, costs.
                   This overestimate is addressed as part of
                   the uncertainties, which is discussed in
                   Chapter 4 of the GWR EA (USEPA,
                   2006d). Further discussion of the
                   alternative approach is also presented
                   there.
                     b. Mixed systems. EPA received
                   comments that regulatory impacts on
                   mixed systems were not adequately
                   characterized because either their costs
                   were underestimated or the
                   methodology for deriving the costs was
                   unclear. Since the available data was
                   insufficient to directly account for
                   ground water entry points in mixed
                   systems, EPA based the cost estimate for
                   mixed systems on the  primarily ground
                   water mixed system inventory report.
                   Primarily ground water mixed systems
                   are systems using ground water for more
                   than 50 percent of their source water;
                   the remainder of their source water is
                   surface water. The primarily ground
                   water-mixed CWSs identified by this
                   calculation were added to the solely
                   GWS inventory to produce the total
                   baseline number of GWSs used in the
                   economic analysis. Because NTNCWSs
                   and TNCWSs are typically a single
                   building or located in  a small area, a
                   simplifying assumption was made for
                   this analysis that all NCWSs draw from
                   a single source water type.
                     The total baseline number of GWSs is
                   treated as ground water-only systems
                   throughout subsequent analyses. This
                   methodology, treating mixed systems as
                   ground water-only systems, may
                   overestimate costs and benefits (i.e.,
some surface water entry points are now
counted as ground water entry points).
However, the ground water entry points
in the excluded mixed surface water
inventory (those mixed systems using
less than 50  percent ground water) are
not included in the analysis, potentially
underestimating costs and benefits. The
contrasting over- and under-accounting
for ground water entry points are
expected to offset one another to some
extent in the cost and benefit analyses.
Data are not  available to quantify the
direction or  magnitude  of the final effect
on overall national cost estimates, but
the effect is expected to be small.
Chapter 4 of the GWR EA (USEPA,
2006d) contains a detailed description
of the methodology for impact analysis
of mixed systems.
  c. Sanitary survey costs. EPA received
comments that the sanitary survey costs
were inadequately estimated because of
lack of considerations of the surveys
currently performed by States and travel
times needed for conducting surveys.
The sanitary survey cost estimates used
in this rule analysis have been updated
based on data that became available
after the proposed GWR. For the
proposed GWR, EPA used the same unit
costs as the ones used in a previous
economic analysis (IESWTR)  for
estimating costs of full sanitary surveys.
Fifty percent of full survey costs was
applied to all systems as the
incremental  costs resulting from the
GWR sanitary survey provision. This
percentage was used to  account for the
more comprehensive survey coverage
(i.e., evaluation of eight elements) under
the GWR than under existing
requirements of the TCR.
  For the final  rule, EPA revised its cost
analysis for conducting sanitary surveys

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65640   Federal Register/Vol.  71, No. 216/Wednesday,  November 8,  2006/Rules  and Regulations
based on new information from States.
First, EPA revised its estimates for
conducting full sanitary surveys
specifically for GWSs with and without
treatment. Second, EPA estimated the
number of additional full sanitary costs
(including travel time costs) that would
result from the higher frequency of
sanitary surveys required under the
GWR, over the number  that is currently
being implemented. This number of
additional sanitary surveys was
multiplied by the sanitary survey unit
costs to estimate national costs for this
effect.
  Third, for those sanitary surveys
already being conducted, EPA estimated
the percentage of systems for which
sanitary surveys would need to be
increased in scope to ensure that all 8
elements were being implemented.
Because all States currently have
sanitary surveys in place under the
IESWTR, TCR^ or other State programs,
most States are now conducting sanitary
surveys at the frequencies and scope
required by the GWR. The revised
sanitary survey costs thus assume no
incremental unit costs in most States
and are substantially lower than the
estimates costed for the proposed GWR.
Chapter 6 of the GWR EA (USEPA,
2006d) contains a detailed discussion of
sanitary survey costing  assumptions.
  d.  Treatment baseline. EPA received
comments that the percentage of
disinfecting systems currently achieving
4-log virus inactivation was
overestimated. For the proposed rule,
EPA based the estimate of systems
achieving 4-log inactivation (77 percent)
on the data from the AWWA
disinfection survey for community
GWSs. EPA recognizes the limited data
resources; AWWA data was the only
source available on a national level and
the disinfection rate estimate used in
the proposed rule is likely to bias high
due to relatively small sample size and
question complexity for the survey.
  In the final GWR EA, EPA re-
evaluated the AWWA data and made a
conservative assumption that those
community GWSs providing insufficient
information for the CT calculation in the
AWWA survey are not currently
achieving 4-log virus inactivation. As a
result, the 4-log disinfection rate was
revised downward to 52 percent.  A
similar change was made for NCWSs.
Chapter 4 of the GWR EA (USEPA,
2006d) provides the detailed discussion
of current disinfection rates.
  e.  Corrective action costs. EPA
received comments that corrective
action costs were underestimated,
especially the costs for  installing
disinfection units. The  commenters
questioned the cost estimates of the
additional land required and the
addition of storage tanks for achieving
sufficient CT values for 4-log virus
inactivation. EPA believes that the unit
costs of technologies provided in the
Technology and Cost Document for the
Final Ground Water Rule (USEPA,
2006h) (T&C document) are adequate to
derive the costs for complying with the
GWR corrective action provisions
because the costs were derived using the
best available published data, vendor
estimates and best professional
judgment.
  EPA understands that some
technologies used to comply with this
rule will not fit within the existing plant
footprints for some systems. When land
costs become expensive, systems have
the flexibility to consider other non-
treatment options such as well
rehabilitation or purchasing water. EPA
further recognizes the land costs as part
of nonquantified costs in the GWR EA
(USEPA, 2006d).
  The T&C document presents the unit
costs of disinfection apart from the unit
costs for storage tanks because
consultation with the field experts
indicates that some systems have
existing storage tanks or certain lengths
of pipes before the first costumers.
Systems that do not have existing
storage tanks will need to consider the
costs for them in cases when they would
need to  meet the CT values for 4-log
inactivation of viruses.  The detention
times in existing facilities could be
sufficient for achieving the 4-log CT
values with disinfectant doses within a
typical range. For these cases, EPA
assumes that no additional storage will
be required for installing disinfection or
that an increase of disinfectant doses
will be feasible for increasing viral
disinfection levels to 4-logs.
  EPA also recognizes that disinfection
and conducting compliance monitoring
may not be preferred by some systems
(particularly for small systems) because
of distribution system size and
configuration or operational complexity
(including compliance monitoring) and
costs. After further consultation with
State representatives, EPA revised the
compliance forecasts for this rule by
lowering the percentages of systems
taking treatment actions (and raising
percentages of systems taking non-
treatment actions) and adding a range of
estimates to quantify the uncertainty
around the compliance forecasts. The
consultation also resulted in the
addition of interim disinfection for
systems taking corrective actions due to
a fecal indicator-positive ground water
source sample. This is because some
immediate protection measures may
have to be in place prior to completing
corrective actions. Chapter 6 of the GWR
EA (USEPA, 2006d) contains a detailed
discussion of the corrective action costs.
  f. Compliance costs for small systems
or NCWSs. Some commenters
questioned whether EPA appropriately
considered the costs to small systems.
As part of the GWR regulatory
development process, EPA participated
in extensive consultations with small
system representatives to develop risk-
based rule requirements that would
minimize the time and financial burden
on small  systems. To address concerns
over the potential cost of additional
monitoring for small systems, the GWR
leverages the existing TCR monitoring
framework to the extent  possible (e.g.,
by using  the results  of the TCR
monitoring to determine if triggered
source water monitoring is required and
by allowing small systems to use TCR
repeat samples to satisfy GWR
requirements). In addition, the
implementation schedule for the
sanitary survey requirement is staggered
(e.g., every three to five years for CWSs
and every five years for NCWSs),
providing some relief for small systems
since there are many more small NCWSs
than CWSs. In addition to the targeted
requirements for minimizing small
systems burden, financial assistance to
small systems may be available from
programs administered by EPA or other
Federal agencies (http://www.epa.gov/
safewater/dwsrf/index.html).
  Some commenters noted that systems
may break into smaller units to fall
below SDWA regulatory thresholds.
Specifically, they noted that if a system
is no longer classified as a PWS, it
would be able to opt out of the GWR
requirements. However,  EPA believes
that systems would  most likely
consolidate with other systems to defray
costs rather than split up and lose
economies of scale and put the public
health at risk. Systems would also have
to consider the transaction costs
associated with dissolving into smaller
units such as drilling new wells and
separating distribution systems.
  EPA also received a number of
comments questioning if the Agency
considered the costs to NCWSs (i.e.,
NTNCWSs and TNCWSs). EPA did
consider the costs to NTNCWSs and
TNCWSs. The baseline number of
systems subject to GWR requirements
was derived from all CWSs, NTNCWSs,
and TNCWSs listed  in the SDW1S
inventory. The new occurrence database
also includes NCWSs. Costs were
estimated by system size and type
corresponding to applicable GWR
requirements and schedules and typical
operating characteristics (e.g.,
population served, treatment in place,

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           Federal  Register/Vol.  71,  No. 216/Wednesday, November 8,  2006/Rules  and Regulations    65641
flows, etc.). Detailed descriptions of all
costing procedures are presented in the
GWR EA (USEPA, 2006d). More
specifically, NTNCWS and TNCWS cost
estimates are presented by system size
in Exhibit 6.40 of the GWR EA.

2. Benefits
   a. Use of occurrence data in risk
assessment.  Some commenters
questioned the basis for EPA using  the
data from the Lieberman et al. (2002)
and Abbaszadegan (Abbaszadegan,  2002
and Abbaszadegan et al., 1999a—c and
2003) studies to represent national
microbial occurrence in the risk
assessment.  Issues raised included  use
of the studies to represent all CWSs and
NCWSs on a national level, use of the
Abbaszadegan et al. data set to represent
"properly constructed wells," and use
of the Lieberman data set to represent
"poorly constructed wells."
   Upon re-examination of all available
occurrence data, EPA has made several
changes to the occurrence analysis  used
to support the risk assessment. The
Agency has made changes to achieve
better representation of viral and fecal
indicator occurrence among all PWS
wells in the  U.S. as  described in Section
VII.B.
  Data from  all the studies used in the
occurrence analysis of the GWR EA
were cited in the NODA (USEPA, 2006e)
and made publicly available. EPA
believes that use of occurrence data
from the cited studies in Section VILA
rather than using only the two studies
used in the GWR EA under the proposal
(Lieberman et al.,  2002; Abbaszadegan,
2002 and Abbaszadegan et al., 1999a-c
and 2003) provides  a better national
estimate of intermittent enterovirus
occurrence in support of the GWR risk
assessment.
  Under the proposed rule, EPA used
the Lieberman ef al. (2002) data set  to
estimate enteric virus occurrence for
poorly constructed wells and the
Abbaszadegan (Abbaszadegan, 2002;
Abbaszadegan et al., 1999a-c and 2003)
data set to estimate enteric virus
occurrence in properly constructed
wells. In this rule, due to data
limitations, EPA assumes the same
enterovirus occurrence and percent time
of viral presence (as described in
Section  VII.B of this preamble) for all
wells.
  In this rule, EPA uses the terminology
"more vulnerable" and "less
vulnerable"  wells as categories for
differing enteric virus concentration
assumptions in differing groups  of
wells. Since  the wells sampled from the
Lieberman ef al. (2002) data were
selected because of likely vulnerability
to fecal contamination, the enteric virus
concentration data from Lieberman et
al. (2002) is assumed to be characteristic
of "more vulnerable" wells. Since the
wells from the Abbaszadegan et al.
(2002) and Lindsey ef al. (2002) studies
were not selected with  a bias toward
greater likelihood of fecal
contamination, enteric  viral
concentrations from these two studies
were assumed to be characteristic of
"less vulnerable" wells. A more
complete  description of this analysis  is
available in Chapters 4 and 5 of the
GWR EA (USEPA, 2006d).
  b. Variability and uncertainty. Some
commenters suggested  that EPA could
do more to address uncertainty and
variability when calculating the benefits
of this rule. As a result  of these
comments, EPA re-evaluated the data
used to support the proposed GWR and
the newer data published since the
proposal. EPA determined that the
values and/or analysis  used in the
proposed  rule should be revised to
better capture variability and
uncertainty. The following discussion
describes the significant changes that
were made in the analysis supporting
this rule as a result of the public
comments and EPA's re-analysis.
  EPA has significantly revised its
modeling of virus and indicator (E. coll)
occurrence in ground water sources of
drinking water in response to public
comments. Section VII.B describes
additional surveys and  their use to
produce a national assessment of
occurrence. The modeling framework
features probabilistic treatments of both
variability and uncertainty.
  In this rule, EPA modified the
mathematical expression that describes
the human challenge studies with
infectious rotavirus (infectivity of the
virus). The purpose of the challenge
study was to determine the rotavirus
dose required to cause  infection in
humans. Previously, EPA used an
approximation to the exact Beta-Poisson
distribution in describing the dose-
response data to simplify the Monte-
Carlo simulation computational
requirements. EPA's primary analysis
now recognizes that the approximation
is poor for some combinations of dose
and parameter values and when used to
predict low  dose risk. As a result, EPA
is using the exact expression for this
rule. In an alternative analysis, EPA
utilizes only data from  the lowest dose
used in the study. That dose (0.9
infectious units) is nearest the most
relevant environmental number
ingested: exactly one infectious unit. An
exponential dose-response model is
applied in the alternative analysis and
the small number of subjects (seven
exposed at this dose) results in
considerable uncertainty about the
model parameter.
  In this rule, EPA maintains as its
primary analysis a Beta-Poisson dose-
response model (Pareto approximation)
utilizing the full echovirus data set but
now includes an alternative analysis in
which an exponential model is utilized
with data from  all but the two highest
dose levels. Subjects who were not
infected at  the high dose levels
demonstrate that different individuals
have different levels of susceptibility (a
feature of the Beta-Poisson model), but
without the high dose data, the
remaining subjects appear equally
susceptible (a feature of the exponential
model). The alternative analysis
predicts significantly lower risk at
environmental exposure levels. EPA's
two analyses demonstrate considerable
uncertainty with respect to model and
data selection.
  In this rule, EPA revised the
morbidity value for rotavirus illness in
adults. The Agency now recognizes that
the variability in this value is
considerable and has included a range
of uncertainty in the morbidity estimate.
Because of limited data on common
source rotavirus outbreaks involving
adults, under the proposal, EPA had
assumed that most adults remain
immune due to multiple repeat
infections,  or if infected, do not often
become ill. Under the proposal, EPA
used a low value for the adult rotavirus
morbidity rate (0.10). However, EPA re-
examined the Ward ef al. (1986) data
and concluded that one-half of the
subjects in  the dose-response study
became ill after infection. Also, since
the proposal, Griffin et al. (2002)
analyzed previous outbreaks and
identified one rotavirus genotype that is
associated with outbreaks involving
adults in the U.S. This new knowledge
suggests that the morbidity value for
adults can be much more variable than
previously  believed depending on
which rotavirus genotype is consumed.
EPA now uses a range in the rotavirus
adult morbidity value from 0.10-0.50
and a uniform distribution. The
distribution selected reflects the
variability among rotavirus genotypes.
  EPA obtained additional echovirus
(Type B) morbidity data to improve the
analysis described in the proposal. The
proposal used only Echovirus type 30
morbidity data from the Seattle Virus
Watch Study (Hall ef al., 1970) based on
the  assumption that data from a single
strain would minimize variability
among the general population. In this
rule, EPA uses multiple echovirus
serotype data from both the Seattle and
New York Virus Watch Studies (Kogon
ef al., 1969) to determine the range of

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65642   Federal Register/Vol.  71, No.  216/Wednesday,  November 8,  2006/Rules  and  Regulations
morbidity rates in the general
population.
  c. Are the benefits and the data used
to estimate the benefits of the GWR
sufficient to justify regulatory action?
EPA received several comments that
addressed the calculation of benefits.
Most commenters questioned whether
the GWR benefits are sufficient to justify
regulatory action. In particular,
comments suggested that the probability
of an outbreak is low and there is no
linkage between undisinfected ground
water and waterborne disease. EPA also
received several comments about the
overall lack of information suitable for
estimating health benefits.
  In general, EPA recognizes that the
health effects data available for use in
calculating GWR benefits are limited
because there are no national
epidemiological studies to identify
waterborne disease from ground water
nor is there any national system for
reporting waterborne disease once  it is
identified.
  EPA has substantially revised its
benefits analysis to use a combination of
measured data, calculated values, and
reasonable assumptions to make
predictions about benefits. The benefits
determined for the GWR are based on
measurement of pathogenic enteric
viruses in public drinking water wells,
so these data are  directly applicable to
making predictions about possible
avoided illnesses due to elimination of
these pathogens from the drinking  water
supply. Furthermore, it should be
recognized that, in the benefits
calculation, EPA does not assume that
pathogen occurrence automatically
results in illness in all individuals
consuming water from that drinking
water supply well. EPA used dose-
response data from human feeding
studies to determine the probability that
an individual would become infected by
consuming water with a range of
pathogen concentrations. For echovirus
(one of the enteroviruses), illness rates
and ranges were determined from
epidemiology studies on the general
population. For rotavirus, illness rates
and ranges were determined from
epidemiology studies on the general
population and from the symptomatic
response to infection in human
challenge studies.
  d. Transparency of regulatory impact
analysis.  Some commenters expressed
that the Regulatory Impact Analysis for
the proposed GWR (USEPA, 2000f) did
not provide a clear description of the
critical assumptions underlying the cost
and benefit analysis.
  EPA believes that it has made the
GWR EA for the final rule more
transparent than the analysis done for
the proposal. Changes include (1)
Expanded text on the basis for most of
the assumptions used in the analysis, (2)
expanded text and new diagrams
describing how the different steps in the
analysis are combined to produce an
aggregate analysis, and (3) expanded
text on how the nonquantified benefits
complement the quantified benefits
analysis.

3. Risk Management
  a. What is EPA's response to
comments that EPA chose the wrong
option and that the benefits do not
justify the cost or that the rule is not
cost-effective? Consistent with EPA's
statutory requirements, the Agency
carefully considered benefits and costs
in proposing and promulgating the
GWR. The Agency's decision for the
final rule is described in VILA. The
Agency believes that this rule provides
benefits at a cost that is justified. In
making decisions for  the final rule, EPA
considered both quantified and
nonquantified benefits and costs as well
as the other components of the Health
Risk Reduction and Cost Analysis
(HRRCA) outlined in  section
1412(b)(3)(C) of the SDWA.
  In the proposal, the Multi-Barrier
approach  (Regulatory Alternative 3) had
net benefits similar to the proposed
regulatory Alternative 2, Sanitary
Survey and Triggered Monitoring.
However, the Multi-Barrier approach
provided a greater reduction in illnesses
and deaths, especially to children. After
an exhaustive review of the benefits and
cost estimates  used in the proposal
resulting from public comments, peer
review, and the NDWAC Arsenic
Review panel, the Agency updated both
the benefit and cost analysis for each
rule option. The risk-targeted approach,
which was selected for the final rule,
has lower net benefits than Alternative
1, but more than Alternatives 3 and 4.
EPA believes that the additional benefits
realized under Alternative 2 justify its
selection over Alternative 1, despite the
lower net benefits.
  Other commenters noted that the
proposed  rule  is not cost-effective. The
mean cost per viral illness avoided for
the final rule ranges from $1,476 to
$1,488, at three percent and seven
percent discount rates respectively.
These represent the lowest values of all
alternatives considered and are much
lower than either Alternative 1  or
Alternative 4. Thus, Alternative 2 is the
most cost-effective rule alternative by
this measure.
  b. Did the Agency consider that some
systems may have negative net benefits,
and did the Agency conduct an
incremental analysis  by system size and
type? Some commenters noted that the
costs may exceed benefits for smaller
size systems. EPA agrees that for some
drinking water regulations the costs may
exceed the benefits because the
populations served by these systems are
much smaller. Generally, large systems
benefit from economies of scale  which
eases the relative impact on these
systems. In addition, many GWR
benefits remain nonquantified.
  Other commenters suggested that EPA
should exclude or set different
standards for small systems based  on
benefit and cost analysis, including
incremental analysis, by system  size or
type. However,  the SDWA  does  not
generally provide a basis for
establishing tailored drinking water
standards as these commenters suggest.
Rather, the SDWA is designed to ensure
uniform levels of public health
protection across the country (except as
specifically provided for in variances
from the standard).
  Thus EPA disagrees with the
suggestion that  the level of the final
standard be altered to address system
size or type. However, as discussed in
detail in the preamble of this rule, the
rule provides flexibility that reduces
burden on small systems and reflects
individual system conditions. Financial
and technical assistance is also available
through various funding authorities.
Regarding affordability, variances based
on affordability are not allowed  by the
SDWA for regulations addressing
microbial contamination, and as a result
EPA did not conduct an affordability
analysis. However, EPA has considered
the SAB review of the Arsenic Rule and
the suggestions of the NDWAC Arsenic
Cost Working Group regarding the
further disaggregation of the analyses.
The NDWAC group recommended
calculation and presentation of cost
information in multiple size categories,
which is done in the GWR EA (USEPA,
2006d).
  In addition, the Agency took many
steps to reduce  the burden on small
systems where possible. More
information regarding this effort can be
found in Chapter 6 of the GWR EA
(USEPA, 2006d).

VIII. Statutory and Executive Order
Reviews

A. Executive Order 12866: Regulatory
Planning and Review
  Under Executive Order (EO) 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 EO
12866 and any changes made in

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           Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations
                                                                     65643
response to OMB recommendations
have been documented in the docket for
this action.
  In addition, EPA has prepared an
analysis of the potential costs and
benefits associated with this action.
This analysis is contained in the
Economic Analysis for the Final Ground
Water Rule (USEPA, 2006d). A copy of
the analysis is available in the docket
for this action and the analysis is briefly
summarized in Section VII of this
preamble.
B. Paperwork Reduction Act
  The Office of Management and Budget
(OMB) has approved the information
collection requirements contained in
this rule under the provisions of the
Paperwork Reduction Act, 44 U.S.C.
3501 et seq. and has assigned  OMB
control number 2040-0271.
  The information collected as a result
of this rule will allow the States and
EPA to make decisions and  evaluate
compliance with the rule. For the first
three  years after the promulgation of the
GWR, the major information
requirements are for States and PWSs to
prepare for implementation of the rule.
The information collection requirements
are described in 40 CFR part 141, for
systems, and part 142, for States, and
are mandatory. The information
collected is not confidential.
  EPA estimates that the annual burden
on PWSs and States for reporting and
recordkeeping will be 385,264 hours.
This annual burden is based on an
estimate that 57 States and territories
will each need to provide one response
each year with an average of 2,193 hours
per response, and that 49,110  systems
will each provide two responses each
year with an average of 2.6 hours  per
response. The total reporting and
recordkeeping cost over the three-year
period of the Information Collection
Request is $30,274,266 (labor  costs)
(USEPA,  2006a). It should be noted,
however, that much of the paperwork
burden of the rule will be incurred only
after the three-year time horizon
covered in this analysis. Subsequent ICR
submissions will address future burden
for activities such as triggered and
compliance monitoring. There are no
operation, maintenance or capital costs
estimated for the first three years. The
labor burden is estimated for the
following activities: reading and
understanding the rule, planning,
training, and meeting primacy
requirements. Burden means the total
time,  effort, or financial resources
expended by persons to generate,
maintain, retain, or disclose or provide
information to or for a Federal agency.
This includes the time needed to review
instructions; develop, acquire, install,
and utilize technology and systems for
the purposes of collecting, validating,
and verifying information, processing
and maintaining information, and
disclosing and providing information;
adjust the existing ways to comply with
any previously applicable instructions
and requirements; train personnel to be
able to respond to a collection of
information; search data sources;
complete and review the collection of
information; and transmit or otherwise
disclose the information.
  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. In
addition, EPA is amending the table in
40 CFR part 9 of currently approved
OMB control numbers for various
regulations to list the regulatory
citations for the information
requirements contained in this rule.

C. Regulatory Flexibility Act (RFA)
  The Regulatory Flexibility  Act (RFA)
generally requires an agency  to prepare
a regulatory flexibility analysis of any
rule subject to notice and comment
rulemaking requirements under the
Administrative Procedure Act or any
other statute unless the agency certifies
that the rule will not have a significant
economic impact  on a substantial
number of small entities. Small entities
include small businesses, small
organizations, and small governmental
jurisdictions.
  The RFA provides default definitions
for each type of small entity.  Small
entities are defined as: (1) A small
business as defined by the Small
Business Administration's (SBA)
regulations at 13 CFR 121.201; (2) a
small governmental jurisdiction that is a
government of a city, county, town,
school district or special district with a
population of less than 50,000; and (3)
a small organization that is any "not-for-
profit enterprise which is independently
owned and operated and is not
dominant in its  field." However, the
RFA also authorizes an agency to use
alternative definitions for each category
of small entity, "which are appropriate
to the activities of the agency" after
proposing the alternative definition(s) in
the  Federal Register and taking
comment.  5 U.S.C. 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 final GWR on small entities, EPA
considered defining "small entities" in
its regulatory flexibility assessments
under the RFA to be public water
systems serving 10,000 or fewer
persons. 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
Small Business Administration (SBA),
and finalized the alternative definition
in the Consumer Confidence Reports
regulation (63 FR 44511, August 19,
1998). As stated in that Final Rule, the
alternative definition applies to this
regulation as well.
  Pursuant to section 603 of the RFA,
EPA prepared an initial regulatory
flexibility analysis (IRFA) for the
proposed rule (see  65 FR 30193, May  10,
2000) and convened a Small Business
Advocacy Review Panel to obtain advice
and recommendations of representatives
of the regulated small entities (USEPA,
2000a). A detailed  discussion of the
Panel's advice and recommendations  is
found in the Panel  Report (docket
number EPA-HQ-OW-2002-0061;
document number  W-98-23-I.E-2). A
summary of the Panel's
recommendations is presented in the
GWR proposal at 65 FR 30253, May 10,
2000 (USEPA, 2000a).
  As required by section 604 of the
RFA,  we also prepared a final regulatory
flexibility analysis  (FRFA) for the final
GWR. The FRFA addresses the issues
raised by public comments on the IRFA,
which was part of the proposal of this
rule. The FRFA is available for review
in the docket and is summarized below.
  EPA is issuing this final rule to
comply with section 1412(b)(8) of the
SOW A", which directs EPA to
"promulgate national primary drinking
water regulations requiring disinfection
as a treatment technique for all public
water systems, including surface water
systems and, as necessary, ground water
systems." The need for tbis final rule is
based upon the substantial likelihood
that fecal contamination of ground
water supplies is occurring at
frequencies and levels that present
public health concern. Fecal
contamination refers to the
contaminants, particularly the
microorganisms, contained in human or
animal feces. These microorganisms
may include bacterial and viral
pathogens, which can cause illnesses in
the individuals that consume them. The
objective of the final GWR is to identify
those systems with fecal contamination
and undertake corrective action to
eliminate or address that contamination.
  Two significant issues were raised in
comments on the IRFA for the proposed
rule. First, several commenters wrote

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65644   Federal Register/Vol. 71, No.  216/Wednesday, November 8, 2006/Rules and Regulations
that small water systems lack the
customer base to defray the costs of
installing new treatment, such as
disinfection, or the cost of a new source.
EPA notes that the final GWR does not
mandate disinfection, but rather is a
flexible regulation, targeting those high-
risk systems or sources that are
vulnerable to contamination. EPA also
notes that financial assistance is
available to small systems through
programs such as tbe Drinking Water
State Revolving Fund, the Loan and
Grant program of the U.S. Department of
Agriculture's Rural Utilities Services
(RUS) and the Community Development
Block Grant Program of the Department
of Housing. The second significant issue
raised in comments on the IRFA was a
recommendation that EPA allow the
States flexibility to consider competing
fiscal impacts on small systems when
implementing the rule. EPA believes the
final rule has greater flexibility and is
less burdensome for States and small
systems than the proposal. For example,
a GWS serving 1,000 people or fewer
may use a repeat sample collected from
a ground water source to meet the TCR
to satisfy the GWR triggered source
water monitoring requirements if the
State approves the use of E. coli  as a
fecal indicator for ground water  source
monitoring.
  EPA assessed the potential impact of
the final GWR on small entities.  There
are 147,330 CWSs, NTNCWSs, and
TNCWSs providing potable ground
water to the public; 145,580 (99percent)
are classified by EPA as small entities.
EPA has determined that all small
systems are impacted by the sanitary
survey requirement and a substantial
number these systems will be impacted
by additional- requirements of the final
GWR, including the triggered source
water monitoring requirements and the
corrective action requirements.
  In addition, in the final GWR there are
a number of recordkeeping and
reporting requirements for all GWSs
(including small systems). To minimize
the burden with these provisions, the
final rule uses a risk-based regulatory
strategy, whereby the monitoring
requirements are based on system
characteristics and not directly related
to system size. In this manner, the rule
takes a system-specific approach to
regulation.
  To prevent conflict and overlap with
other Federal rules, this final rule
leverages the existing TCR monitoring
framework to the extent possible (e.g.,
by using the results of the routine TCR
monitoring to determine if source water
monitoring is required). GWSs that do
not reliably treat to 4-log inactivation or
removal of viruses are required to
collect a source water sample following
a total coliform-positive sample in the
distribution system. Additionally,
systems may utilize one of the follow-
up monitoring samples required under
the TCR to meet the triggered source
water sampling requirements of this
final rule.
  As a result of the input received from
stakeholders, the EPA workgroup, and
other interested parties, EPA
constructed four regulatory options: The
sanitary survey option, the sanitary
survey and triggered monitoring option,
the multi-barrier option, and the across-
the-board disinfection option. In
developing this final rule, EPA
considered the recommendations to
minimize the cost impact to small
systems. A risk-targeted approach, based
on sanitary surveys and triggered source
water monitoring (which only requires
corrective action if the GWS has a
sanitary survey significant deficiency or
source water fecal contamination), was
selected as the option to protect public
health and to reduce burden.
Assessment source water monitoring,
part of the preferred proposal option
(the multi-barrier option), has been
finalized as a discretionary requirement
as determined by the State, allowing
further flexibility and burden reduction.
  To mitigate the associated compliance
cost increases across water systems, this
final rule also provides States with
considerable flexibility when
implementing other requirements of the
rule. This flexibility will allow States to
consider the characteristics of
individual systems when determining
an appropriate corrective action. For
example, States have the flexibility to
allow systems to fix existing wells, drill
a new well, obtain a new source, or use
any disinfection treatment technology
that achieves 4-log inactivation or
removal of viruses. States may also
determine that the source of
contamination has been eliminated if,
after thorough investigation by the State
and the system, the State concludes that
contamination is unlikely to reoccur.
  As required by section 212 of the
Small Business Regulatory Enforcement
Fairness Act (SBREFA), EPA also is
preparing a Small Entity Compliance
Guide to help small entities comply
with this rule. This guide will be
available on EPA's Web site at http://
www.epa.gov/safewater/disinfection/
gwr/index.html or by calling  the Safe
Drinking Water Hotline at (800) 426-
4791.

D. Unfunded Mandates Reform Act
(UMRA)
  Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Pub. L.
104-4, establishes requirements for
Federal agencies to assess the effects of
their regulatory actions on State, local,
and Tribal governments and the private
sector. Under section 202 of UMRA,
EPA generally must prepare a written
statement, including a cost-benefit
analysis, for proposed and final rules
with "Federal mandates" 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.
Before promulgating an EPA rule for
which a written statement is needed,
section 205 of the UMRA generally
requires EPA to identify and consider a
reasonable number of regulatory
alternatives  and adopt the  least costly,
most cost-effective or least burdensome
alternative that achieves the objectives
of the rule. The provisions of section
205 do not apply when they are
inconsistent with applicable law.
Moreover, section 205 allows EPA to
adopt an alternative other than the least
costly, most cost-effective or least
burdensome alternative if the
Administrator publishes with the final
rule an explanation why that alternative
was not adopted. Before EPA establishes
any regulatory requirements that may •
significantly or uniquely affect small
governments, including Tribal
governments, it must have developed
under section 203 of the UMRA a small
government agency plan. The plan must
provide for notifying potentially
affected small governments, enabling
officials of affected small governments
to have meaningful and timely  input in
the development of EPA regulatory
proposals with significant Federal
intergovernmental  mandates, and
informing, educating, and  advising
small governments on compliance with
the regulatory requirements.
  EPA has determined that this rule
does not contain a Federal mandate that
may result in expenditures of $100
million or more for State, local, or Tribal
governments in the aggregate, or the
private sector in any one year (see Table
VIII-1). The rule is estimated to cost
State, local and Tribal governments
$41.5 to $41.9 million. Public water
systems that are privately owned will
incur total costs of $20.3 to $20.4
million per year. A more detailed
description is presented in the
Economic Analysis for the Final Ground
Water Rule (USEPA, 2006d), which is
available in  the water docket. Thus, this
rule is not subject to the requirements
of sections 202 and 205 of the UMRA.

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           Table VIII-1: Ground Water System, State, and Tribal Estimated Costs

           (Note: Detail may not add up to totals due to independent rounding)

Ground Water Systems Costs
State Costs
Tribal Costs
Total Public
Ground Water Systems Costs
Total Private
GRAND TOTAL
3% Discount
Rate
$ 29.5
$ 11.8
$ 0.2
$ 41.5
$ 20.3
$ 20.3
$ 61.8
7% Discount
Rate
$ 30.0
$ 11.7
$ 0.2
$ 41.9
$ 20.4
$ 20.4
$ 62.3
Percent of 3%
Grand Total
Costs
48%
19%
0%
67%
33%
33%
100%
Percent of 7%
Grand Total
Costs
48%
19%
0%
' 67%
33%
33%
100%
  In developing this rule, EPA
consulted with small governments
pursuant to its interim plan established
under section 203 of the UMRA to
address impacts of regulatory
requirements in the rule that might
significantly or uniquely affect  small
governments. EPA held four public
meetings for all stakeholders. Because of
the GWR's impact on small entities, the
Agency convened a Small Business
Advocacy Review (SBAR) Panel in
accordance with the Regulatory
Flexibility Act (RFA) as amended by the
Small Business Regulatory Enforcement
Fairness Act (SBREFA) to address small
entity concerns, including small local
governments specifically. EPA
consulted with small entity
representatives prior to convening the
Panel to get their input on the GWR. Of
the 22 small entity participants, five
represented small governments. EPA
also made presentations on the  GWR to
the national and some local chapters of
the American Water Works Association,
the Ground Water Foundation, the
National Ground Water Association, the
National Rural Water Association, and
the National League of Cities.

E. Executive Order 13132: Federalism
  Executive Order 13132, entitled
"Federalism" (64 FR 43255, August 10,
1999), requires EPA to develop  an
accountable process to ensure
"meaningful and timely input by  State
and local officials in the development of
regulatory policies that have federalism
implications."  "Policies that have
federalism implications" is defined in
the Executive Order to include
regulations that 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."
  This final rule 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. This rule does
not contain a "significant Federal
government mandate" under section
202 of the UMRA, nor does it have a
significant impact on small
governments. Thus, Executive Order
13132  does not apply to this rule.
  Although Section 6 of Executive
Order 13132 does not apply to this rule,
EPA did consult with State and local
officials in developing this rule (65 FR
30203 and 30263, May 10, 2000)
(USEPA, 2000a). A summary of the
concerns raised during that consultation
and EPA's response to those concerns
are provided in the proposal. In the
spirit of Executive Order 13132, and
consistent with EPA policy to promote
communications between EPA and State
and local governments, EPA specifically
solicited comment on the proposed rule
from State and local officials.
F. Executive Order 13175: Consultation
and Coordination With  Indian Tribal
Governments
  Executive Order 13175, entitled
"Consultation and Coordination with
Indian Tribal Governments" (65 FR
67249, November 9, 2000), requires EPA
to develop "an accountable process to
ensure meaningful and timely input by
tribal officials in the development of
regulatory policies that  have tribal
implications." Under Executive Order
13175, EPA may not issue a regulation
that has Tribal implications, that
imposes substantial direct compliance
costs, and that is not required by statute,
unless  the Federal government provides
the funds necessary to pay the direct
compliance costs incurred by Tribal
governments, or EPA consults with
Tribal officials early in the process of
developing the proposed regulation and
develops a Tribal summary impact
statement.
  EPA has concluded that this final rule
may have Tribal  implications because it
may impose substantial direct
compliance costs on Tribal governments
and the Federal government will not
provide the funds necessary to pay
those costs. This rule will significantly
affect communities of Tribal
governments because 87 percent of
PWSs in Indian Country are GWSs.
Accordingly, EPA provides the
following Tribal  summary impact
statement as required by section 5(b).
  EPA consulted with Tribal officials
early in the process of developing this
regulation to permit them to have
meaningful and timely input into its
development (see the proposed rule, 65
FR 30259, May 10, 2000) (USEPA,
2()00a). Two consultations took place at
national conferences; one for the
National Indian Health Board and the
other for the National Tribal
Environmental Council. A third
consultation was conducted in
conjunction with the  Inter-Tribal
Council of Arizona, Inc. EPA received
one comment on the proposed rule from
a Tribal organization. The organization
is concerned that the  GWR will have a
negative impact on their ability to
provide infrastructure improvements by
taking funding resources away from new
water supply construction programs and
applying these funds to cover
compliance costs for existing water
systems. EPA recognizes that the GWR
will increase the  compliance burden for
some Tribal PWSs, however, EPA
believes that the  GWR will provide
public health benefits that justify the
increase in burden. To offset some of
this burden, EPA has  provided
flexibility for small systems through
various mechanisms.  For a detailed
discussion, please see Section IV of this
preamble.

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65646   Federal Register/Vol. 71, No.  216/Wednesday,  November 8, 2006/Rules and  Regulations
  As required by section 7(a), EPA's
Tribal Consultation Official has certified
that the requirements of this Executive
Order have been met in a meaningful
and timely manner. A copy of the
certification is included in the docket
for this rule.

G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
  Executive Order 13045: "Protection of
Children from Environmental Health
Risks and Safety Risks" (62 FR 19885,
April 23, 1997) applies to any rule that:
(1) Is determined to be "economically
significant" as defined under Executive
Order 12866, and  (2) concerns an
environmental health or safety risk that
EPA has reason to believe may have  a
disproportionate effect on children. If
the regulatory action meets both criteria,
the Agency must evaluate the
environmental health or safety effects of
the planned rule on children, and
explain why the planned regulation  is
preferable to other potentially effective
and reasonably feasible alternatives
considered by the Agency.
  While this final  rule is not subject to
the Executive Order because it is not
economically significant as defined
under Executive Order 12866, we
nonetheless have reason to believe that
the environmental health or safety risk
addressed by this action may have a
disproportionate effect on children. As
a matter of EPA policy, we therefore
assessed the environmental health or
safety effects of viruses on  children.  The
results of this assessment are contained
in Section VII.I.I of the preamble of this
rulemaking as well as in the final GWR
EA (USEPA, 2006d).

H. Executive Order 13211:  Actions That
Significantly Affect Energy Supply,
Distribution, or Use
  This rule is not a "significant energy
action"  as defined in Executive Order
13211, "Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use" (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.

1. Energy Supply
  The GWR does not regulate power
generation, either  directly or indirectly.
The public and private PWSs that the
GWR regulates do not, in general,
generate power. Further, the cost
increases borne by customers of PWSs
as a result of the GWR represent a small
percentage of the total cost of water,
except for a very few small systems that
will need to spread the cost of installing
advanced technologies over a narrow
customer base. Therefore, the customers
that are power generation utilities are
unlikely to face any significant effects as
a result of the GWR. In summary, the
GWR does not regulate the supply of
energy, does not generally regulate the
utilities that supply energy, and is
unlikely to significantly affect the
customer base of energy suppliers.
Thus, the GWR will not adversely affect
the supply of energy.

2. Energy Distribution
  The GWR does not  regulate any aspect
of energy distribution. PWSs that are
regulated by the GWR already have
electrical service. The rule is projected
to increase peak electricity demand at
PWSs by only 0.001 percent (see below).
Therefore, EPA assumes that the
existing connections are adequate and
that the GWR has no discernable
adverse effect on energy distribution.

3. Energy Use
  Some PWSs are expected to add
treatment technologies that use
electrical power. This potential impact
of the GWR on the use of energy was
evaluated. The analyses that underlay
the estimation of costs are national in
scope and do not identify specific plants
or systems that may install treatment in
response to the GWR. As a result, no
analysis of the effect on specific energy
suppliers is possible with the available
data. Further data are required to
evaluate the effect on specific energy
suppliers. The approach used to
estimate the impact of energy use,
therefore, focuses on national-level
impacts. In this approach, EPA
estimates the additional energy use due
to the GWR and compares that to  the
national levels of power generation in
terms of average and peak loads.
  The first step is to estimate the  energy
used by the technologies or corrective
action expected to be installed as a
result of the GWR. Energy use is not
directly estimated in the Technology
and Cost Document for the Final
Ground Water Rule (USEPA, 2006h), but
the annual cost of energy  for each
technology and corrective action
addition or upgrade necessitated by the
GWR is provided. An estimate of  plant-
level energy use is derived by dividing
the total energy cost per plant for a
range of flows by an average national
cost of electricity of $0.076 per kilowatt
hour per year (kWh/y) (USDOE EIA,
2002). The energy use per plant for each
flow range and technology or corrective
action is then multiplied by the number
of plants predicted to install each
technology in a given flow range.  The
energy requirements for each flow range
are then added to produce a national
total. No electricity use is subtracted to
account for the technologies that may be
replaced by new technologies, resulting
in a conservative estimate of the
increase in energy use. An incremental
national annual energy usage of 4,521
megawatt hours (mWh) was calculated.
  The total increase in energy usage by
water systems as a result of the GWR is
predicted to be approximately 4.5
million kWh/y, which is less than  one-
ten-thousandth of one percent of the
total energy produced in 2003. While
the rule may have some adverse energy
effects, EPA does not believe that this
constitutes a significant adverse effect
on the energy supply. See the Economic
Analysis for the Final Ground Water
Rule '(USEPA, 2006d) for further detail.

/. National Technology Transfer and
Advancement Act
  As noted in the proposed rule,
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. The"NTTAA directs EPA to
provide Congress, through OMB,
explanations when the Agency decides
not to use available and applicable
voluntary consensus standards.
  This rulemaking involves technical
standards. EPA has identified some
consensus standards and developed or
modified methods for the remaining
methods requirements. These methods
are listed in § 141.402(c).
  Most of the methods that EPA is
approving for the detection  of E. coli in
source waters are consensus methods
described in Standard Methods for the
Examination of Water and Wastewater
(20th Edition) (APHA, 1998). The three
E. coli methods that are not consensus
methods are newly developed: MI  agar
(a membrane filter method), the
ColiBlue 24 test (a membrane filter
method) and the E*Colite test (a defined
dehydrated medium to which water is
added). EPA has already evaluated and
approved these three methods for use
under the TCR. Of the three enterococci
methods EPA is approving in this rule,
two are consensus methods in Standard
Methods; the third (Enterolert) was
described in a peer-reviewed journal
article (Budnick  et al., 1996).

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           Federal  Register/Vol. 71, No.  216/Wednesday,  November 8, 2006/Rules and Regulations    65647
  The two methods EPA proposed for
the detection of coliphage in source
water are not consensus methods. For
the coliphage tests, EPA is approving
the use of two methods: EPA Method
1601 (Two-Step Enrichment Presence-
Absence Procedure) (USEPA, 2001a)
and EPA Method 1602 (Single Agar
Layer Procedure) (USEPA, 2001b). EPA
Method 1601 is a new method
optimized for the detection of a single
coliphage in a small (100-1,000 mL)
water sample. EPA did not use the
consensus method for coliphage in
Standards Methods (20th edition)
(Method 9211D) (APHA, 1998) rather,
EPA modified and optimized Method
9211D to improve its sensitivity and
versatility.
/. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations

  Executive Order 12898 establishes a
Federal policy for incorporating
environmental justice into Federal
Agency missions by directing agencies
to identify and address
disproportionately high and adverse
human health or environmental effects
of its programs, policies, and activities
on minority and low-income
populations.
  The Environmental Justice Executive
Order requires the Agency to consider
environmental justice issues in the
rulemaking and to consult with
minority and low-income stakeholders.
The Agency has considered
environmental justice issues concerning
the potential impacts of this action and
has consulted  with minority and low-
income stakeholders. The GWR applies
to all PWSs (CWSs, NTNCWSs, and
NTCWSs) that use ground water as their
source water. Consequently, the health
protection benefits provided by this rule
are  equal across all income and minority
groups served  by these systems. Existing
regulations such as the SWTR, IESWTR,
and LT2ESWTR provide similar health
benefit protection to communities that
use surface water or ground water under
the  direct influence of surface  water.
  Nonetheless, the Agency held a
stakeholder meeting on March 12, 1998,
to address various components of
pending drinking water regulations and
how they may impact sensitive sub-
populations, minority populations, and
low-income populations. See the
discussion of this meeting in the
proposed rule for further information
(65  FR 30261, May 10, 2000) (USEPA,
2000a).
K. Congressional Review Act
  The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S.  Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule  in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is a "major rule" as defined
by 5 U.S.C. 804(2). This rule will be
effective January 8, 2007.
L. Analysis of the Likely Effect of
Compliance With the GWR on the
Technical, Financial, and Managerial
Capacity of Public Water Systems
  Section 1420(d)(3) of SDWA, as
amended, requires that in promulgating
an NPDWR, the Administrator shall
include an analysis of the likely  effect
of compliance with the regulation on
the technical, managerial, and financial
capacity of public water systems. This
analysis can be found in the GWR
Economic Analysis (USEPA, 2006d).
Analyses reflect only the impact of new
requirements, as established by the
GWR; the impacts  of previously
established requirements on system
capacity are not considered.
IX.  Consultation With  Science Advisory
Board, National Drinking Water
Advisory Council, and the Secretary of
Health and Human Services; and Peer
Review
  In accordance with sections 1412(d)
and 1412(e) of the  SDWA, the Agency
consulted with the Science Advisory
Board, the  National Drinking Water
Advisory Council (NOWAC), and the
Secretary of Health and Human
Services.
  In addition, this rule was supported
by influential scientific information.
Therefore,  the Agency  conducted a peer
review in accordance with OMB's Final
Information Quality Bulletin for  Peer
Review (OMB, December 15, 2004). EPA
developed charge questions related to
the  statistical approach used to
characterize national occurrence of viral
pathogens and fecal indicators; risk
characterization including dose-
response modeling; characterization of
morbidity, mortality, and severity for
Type A and Type B viruses;
characterization of nonquantified
benefits; and national risk reduction
(benefits) and costs for the GWR. The
Peer Review Report is located in the
docket for this rule.

X. References
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Abbaszadegan, M., P.W. Stewart, M.W.
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Abbaszadegan, M.. P.W. Stewart, and M.W.
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    Knipe, and P.M. Howrey. eds. Fields
    Virology. Philadelphia, Lippincott Raven
    Publishers.
Miller, K.J. and J. Meek. 2006. Helena Valley
    Ground Water: Pharmaceuticals,
    Personal Care Products, Endocrine
    Disruptors (PPCPs) and Microbial
    Indicators of Fecal Contamination.
    Montana Department of Environmental
    Quality Open File Report.
Minnesota Department of Health. 2000.
    Minnesota Department of Health Viral
    Occurrence Study. 7 pp.
Missouri Department of Health. 1992.
    Summary of Investigation, Hepatitis A
    Outbreak, Apostolic Church and School,
    Racine. MO. Unpublished report. 5 pp.
Modlin. J.F. 1986. Perinatal Echovirus
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    of Infectious Diseases. 8(6):918-926.
Modlin, J.F. 1997. Enteroviruses:
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    enteroviruses. In: Long. S.S., et al. eds.
    Principles and Practice of Pediatric
    Infectious Diseases. New York, Churchill
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Moore, A.C.. B.L. Herwaldt, G.F. Craun. R. L.
    Galderon, A.K. Highsmith. and D.D.
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    waterborne disease outbreaks—United
    States, 1991-1992. Morbidity and
    Mortality Weekly Report. Surveillance
    Summary SS-5, U.S. Centers for Disease
    Control and Prevention. 42(SS-05):l-22.
National  Drinking Water Advisory Council.
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National  Research Council. 1997. Safe Water
    From Every Tap, Improving Water
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    Academy Press, Washington, DC.
New York State Department of Health. 2000.
    The Washington County fair outbreak
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Ohio EPA. 2005. South Bass Island, Ottawa
    County Gastrointestinal Illness Summer
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    Reports/SBI_EPA.pdf.
Olsen, S.J.. G. Miller, T. Breuer, M. Kennedy,
    C. Higgins, J. Walford, G. McKee, K. Fox,
    W. Bibb, and P. Mead. 2002. A
    watorborne outbreak of Escherichia coli
    O157:H7 infections and hemolytic
    uremic syndrome: implications for rural
    systems. Emerging Infectious Diseases.
    8(4):370-375.
OMB. 2004.  Final Information Quality
    Bulletin fo' Peer Review. December 15,
    2004. 41 pp, http://www.whitehouse.gov/
    om b/in foreg/peer2004/peer_bul letin.pdf.
Parshionikar, S.U., S. Willian-True, G.S.
    Fout, D.E. Robbins, S.A. Seys, J.D.
    Cassady, and R. Harris. 2003. Waterborne
    outbreak of gastroenteritis associated
    with  a norovirus. Applied and
    Environmental Microbiology.
    69(9):5263-5268.
Rice, E.W., M.R. Rodgers, I.V. Wesley, C.H.
    Johnson, and S.A.  Tanner. 1999.
    Isolation of Arcobacter butzleri from
    ground water. Letters in Applied
    Microbiology. 28:31-35.
Rose, J.B. 1997. Environmental ecology of
    Cryptosporidium and public health
    implications. Annual Rev Public Health.
    18:135-161.
Smith, W.G. 1970. Coxsackie B
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    8()(l):34-46.
Swerdlow, D.L,, B.A. Woodruff, R.G. Brady,
    P.M. Griffin. S. Tippen, H. Donnel Jr.,'E.
    Geldreich, B.J. Payne, A. Meyer Jr., J.G.
    Wells, K.D. Greene, M. Bright, N.H.
    Bean, and P.A. Blake. 1992. A
    waterborne outbreak in Missouri of
    Escherichia coli O157:H7 associated
    with bloody diarrhea and death. Annals
    of Internal Medicine. 117(10):812-819.
Szewzyk. U., Szewzyk, R., Manz.  W. and
    Schleifer, K.-H. 2000. Microbiological
    safety of drinking water. Annual Review
    of Microbiology.  54:81-127.
Tucker, A.W., A.C/Haddix, J.S. Bresee. et al.
    1998. Cost-effectiveness analysis of a
    rotavirus immunization program for the
    United States. JAMA. 279(17):1371-
    1376.
U.S. Department of Energy, Energy
    Information Administration. 2002. Table
    7.1 Electricity Overview (Billion
    Kilowatthours). http://www.eia.doe.gov/
    emeu/mer/txt/mer7-l
USEPA. 2006a.  Information Collection
    Request for National Primary Drinking
    Water Regulations: Final Ground  Water
    Rule. EPA-815-R-06-011.
USEPA. 2006b.  Occurrence and Monitoring
    Document for the Final Ground Wafer
    Rule. EPA-815-R-06-012.
USEPA. 2006c.  Public Comment and
    Response Document for the Final
    Ground Water Rule. EPA-815-R-06-
    013.
USEPA. 2006d. Economic Analysis for the
    Final Ground Water Rule. EPA-815-R-
    06-014.
USEPA. 2006e. National Primary Drinking
    Water Regulations; Ground Water Rule:
    Notice of Data Availability. 71 FR 15105,
    March 27, 2006.
USEPA. 2006f. National Field Study for
    Coliphage Detection in Groundwater:
    Method 1601  and 1602 Evaluation in
    Regional Aquifers. EPA-822-R-06-002.
USEPA. 2006g. National Primary Drinking
    Water Regulations: Stage 2 Disinfectants
    and Disinfection  Byproducts Rule; Final
    Rule. 71 FR 388,  January 4, 2006.
USEPA. 2006h.  Technology and Cost
    Document for the Final Ground Water
    Rule. EPA-815-R-06-015.
USEPA. 2006i. National Primary Drinking
    Water Regulations: Long Term 2
    Enhanced Surface Water Treatment Rule
    ILT2ESWTR); Final Rule. 71 FR 654,
    January 5, 2006.
USEPA. 2005a. Membrane Filtration
    Guidance Manual. November, 2005. EPA
    815-R-06-009.
USEPA. 2005b. Manual for the Certification
    of Laboratories Analyzing Drinking
    Water. Fifth Edition,"January, 2005. EPA
    815-R-05-004.
USEPA. 2003a. Results of the Interlaboratory
    Validation of EPA Method 1601 for
    Presence/Absence of Malespecific (F+)
    and Somatic Coliphage in Water by Two-
    Step Enrichment. July, 2003. EPA-821-
    R-03-015.
USEPA. 2003b. Results of the Interlaboratory
    Validation of EPA Method 1602 for

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Federal Register/Vol. 71,  No.  216/Wednesday, November 8,  2006/Rules and  Regulations
    Enumeration of Malespecific (F+) and
    Somatic Coliphage in Water by Single
    Agar Layer (SAL). July. 2003. EPA-821-
    R-03-016.
USEPA. 2003c. Children's Health Valuation
    Handbook. October, 2003. EPA 100-R-
    01-002.
USEPA. 2002a. Method 1600. September.
    2002. EPA 821-R-02-022.
USEPA. 2002b. National Primary Drinking
    Water Regulations: Announcement of the
    Results ofEPA's Review of Existing
    Drinking Water Standards and Request
    for Public Comment. 67 FR 19030. April
    17, 2002.
USEPA. 2002c. 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.
USEPA. 2001a. Method 1601: Male-specific
    (F+) and Somatic Coliphage in Water by
    Two-step Enrichment Procedure. Office
    of Water, U.S. Environmental Protection
    Agency, Washington, DC 20460. EPA
    821-R-01-030.
USEPA. 2001b. Method 1602: Male-specific
    (F+) and Somatic Coliphage in Water bv
    Single Agar Lover (SAL) Procedure.
    Office of Water, U.S. Environmental
    Protection Agency, Washington, DC
    20460. EPA 821-R-01-029.
USEPA. 2000a. National Primary Drinking
    Water Regulations: Ground Water Rule:
    Proposed Rule. 65 FR 30194, May 10,
    2000. EPA-815-Z-00-002.
USEPA. 2000b. Stage 2 Microbial and
    Disinfection Byproducts Federal
    Advisory Committee Agreement in
    Principle. 65  FR 83015, December 29,
    2000.
USEPA. 2000c. Guidelines for Preparing
    Economic Analyses. September, 2000.
    EPA 240-R-00-003.
USEPA. 2000d. Science Advisory Board Final
    Report.  Prepared for Environmental
    Economics Advisory Committee. July 27,
    2000. EPA-SAB-EEAC-00-013.
USEPA. 2000e. Health Risks of Enteric Viral
    Infections in Children. Office of Science
    and Technology, Washington, DC. EPA-
    822-R-00-010'
USEPA. 2000f. Regulatory Impact Analysis of
    the Proposed Ground Water Rule. April
    5, 2000.
USEPA. 2000g. Baseline Profile Document for
    the Ground Water Rule. Final Draft. July,
    2000.
USEPA. 2000h. Science Advisory Board
    Letter Report on EPA's Draft Proposal for
    the Ground Water Rule. June 30,  2000.
    EPA-SAB-DWC-LTR-00-005.
USEPA. 2000L National Drinking Water
    Advisory Council Recommendations.
    May 11, 2000.
USEPA." 2000J. National Primary Drinking
    Water Regulations: Public Notification
    Rule. 65 FR 25982, May 4, 2000.
USEPA. 1999. Drinking Water Criteria
    Document for Enteroviruses and
    Hepatitis A: An Addendum. January 15,
    1999. EPA-822-R-98-043.
USEPA. 1998a. GWR vulnerability
    assessment study, April 3,1998.
    Unpublished report prepared by
                                  International Consultants, Inc. for the
                                  Office of Ground Water and Drinking
                                  Water, 29 pp.
                               USEPA. 1998b. National Primary Drinking
                                  Water Regulations. Interim Enhanced
                                  Surface Water Treatment Rule
                                  (IESWTR). 63 FR 69477, December 16,
                                  1998.
                               USEPA. 1998c. National Primary Drinking
                                  Water Regulations: Disinfectants and
                                  Disinfection Byproducts: Final Rule. 63
                                  FR 69389, December 16, 1998.
                               USEPA. 1998d. Wisconsin migrant worker
                                  camp drinking water quality study.
                                  Unpublished report. Prepared for U.S.
                                  EPA Region V, Safe Drinking Water
                                  Branch. July, 1998. 10 pp.
                               USEPA. 1997a. Ground Water Disinfection
                                  Rule Workshop on Ground Water
                                  Protection Barrier Elements—Final
                                  Proceedings. March 26-28, 1997.
                               USEPA. 1997b. Response to Congress on Use
                                  of Decentralized Wastewater Treatment
                                  Systems. April. 1997. EPA 832-R-97-
                                  OOlb.
                               USEPA. 1997c. Policy for Use of Probabilistic
                                  Analysis in Risk Assessment. Office of
                                  Research and Development. May 15,
                                  1997.
                               USEPA. 1997d. EPA Method 1600:
                                  Membrane Filter Test Method for
                                  Enterococci in Water." May. 1997. EPA-
                                  821-R-97-004.
                               USEPA. 1996. Ground Water Disinfection
                                  Rule—Workshop on Predicting Microbial
                                  Contamination of Ground Water
                                  Systems—fuly 10-11, 1996—Proceedings
                                  Report. September 1996.
                               USEPA. 1995a. EPA Risk Characterization
                                  Program. Memorandum. March 21, 1995.
                               USEPA. 1995b. Guidance for Risk
                                  Characterization. Science Policy
                                  Council. February. 1995. 15 pp.
                               USEPA/Association of State Drinking Water
                                  Administrators (ASDWA). 1995. EPA/
                                  State Joint Guidance on Sanitary
                                  Surveys. December 1995. Pp.1-8.
                               USEPA. 1992. Draft Ground-Water
                                  Disinfection Rule Available for Public
                                  Comment. Notice of Availability and
                                  Review in 57 FR 33960, July 3l", 1992.
                               USEPA. 1991. Guidance Manual for
                                  Compliance with the Filtration and
                                  Disinfection Requirements for Public
                                  Water Systems Using Surface  Water
                                  Sources. Contract No. 68-01-6989.
                               USEPA. 1990. Drinking Water;
                                  Announcement of Public Meeting to
                                  Discuss the Preliminary Concept Paper
                                  for the Ground Water Disinfection
                                  Requirements. Meeting Notice. 55 FR
                                  21093, May 22. 1990.
                               USEPA. 1989a. DrinWng Water: National
                                  Primary Drinking Wafer Regulations:
                                  Total Coliforms (Including Fecal
                                  Coliforms and E. Coli); Final Rule. 54 FR
                                  27544, June 29, 1989.
                               USEPA. 1989b. Drinking Water: National
                                  Primary Drinking IVoter Regulations:
                                  Disinfection: Turbidity, Giardia lamblia,
                                  Viruses, Legionella, and Heterotrophic
                                  Bacteria: Final Rule. 54 FR 27486, June
                                  29, 1989.
                               USEPA/Science Advisory Board (SAB). 1990.
                                  Reducing Risk: Setting Priorities and
                                  Strategies for Environmental Protection.
                                  September, 1990. SAB-EC-90-021.
US Government Accountability Office
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    1993.
Vaughn, J.M. 1996. Sample Analyses.
    Attachment, unpublished letter on the
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    J. Lane and K. Duzan, Missouri
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    in Volunteers: Determination of
    Infectious Dose and Serological
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    Infectious Diseases. 154(5):871.
Worthington, S.R.H.. C.C. Smart, and W.W.
    Ruland. 2002. Assessment of
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    D. Stolle, A.R. Piggott and J.J. Crowder'
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    Society. Pp. 1081-1086.
Yanko, W.A., J.L. Jackson, P.P. Williams, A.S.
    Walker, and M.S. Castillo. 1999. An
    unexpected temporal pattern of
    coliphage isolation in ground waters
    sampled from wells at varied distance
    from reclaimed water recharge sites.
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    A.M. Salazar.  1999. Detecting
    Enteroviruses in Water: Comparing
    Infectivity, Molecular, and Combination
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    Association. International Symposium
    on Waterborne Pathogens, Milwauke,
    WI.

List of Subjects

40 CFR Part 9
  Reporting and recordkeeping
requirements.

40 CFR Part 141
  Environmental protection, Chemicals,
Indians-lands, Incorporation by
reference, Intergovernmental relations,
Radiation protection, Reporting and
recordkeeping requirements, Water
supply.

40 CFR Part 142

  Environmental protection,
Administrative practice and procedure,
Chemicals, Indians-lands, Radiation
protection, Reporting and recordkeeping
requirements,  Water supply.
  Dated: October 11, 2006.
Stephen L. Johnson,
Administrator.
  For the reasons set forth in the
preamble, title 40 chapter I of the Code
of Federal Regulations is amended as
follows:

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           Federal  Register/Vol.  71,  No. 216/Wednesday,  November 8, 2006/Rules and Regulations    65651
PART 9—OMB APPROVALS UNDER
THE PAPERWORK REDUCTION ACT

• 1. The authority citation for part 9
continues to read as follows:
  Authority: 7 U.S.C.  135 et seq., 136-136y;
15 U.S.C. 2001, 2003,  2005, 2006, 2601-26~71;
21 U.S.C. 331J, 346a, 348; 31 U.S.C. 9701: 33
U.S.C. 1251 et seq., 1311, 1313d. 1314. 1318,
1321, 1326, 1330, 1342. 1344, 1345 (d) and
(e), 1361: Executive Order 11735, 38 FR
21243, 3 CFR, 1971-1975 Comp. p. 973; 42
U.S.C. 241, 242b. 243, 246, 300f, 300g, 300g-
1.300g-2,300g-3,300g-4, 300g-5. 300g-6,
300J-1, 300J-2. 300J-3, 300J-4, 300J-9, 1857
et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
• 2. In § 9.1 the table is amended by
adding entries § 141.401-141.405",
§ 142.14(d)(17)", § 142.15(c)(7}" and
§ 142.16(o)" in numerical order, as
follows:

§ 9.1  OMB approvals under the Paperwork
Reduction Act.
                                             40 CFR citation
                                                                  OMB control
                                                                      No.
                                       National Primary Drinking Water Regulations
141.401-141.405
                                                                                                           2040-0271
                                National Primary Drinking Water Regulations Implementation
142.14(d)(17)
                                                                    2040-0271
142.15(c)(7)
                                                                    2040-0271
142.16(0) ...
                                                                    2040-0271
PART 141—NATIONAL PRIMARY
DRINKING WATER REGULATIONS

• 3. The authority citation for part 141
continues to read as follows:
  Authority: 42 U.S.C. 300f, 300g-l, 300g-2.
300g-3, 300g-4, 300g-5, 300g-6, 300J-4,
300J-9, and 300J-11.

• 4. Section 141.21 is amended by
adding paragraph (d)(3) to read as
follows:

§ 141.21   Coliform sampling.
*****
  (d) * *  *
  (3) Sanitary surveys conducted by the
State under the provisions of
§ 142.16(o)(2) of this chapter may be
used to meet the sanitary survey
requirements of this section.
*****
• 5. Section 141.28 is amended by
revising paragraph (a) to read as follows:

§ 141.28   Certified laboratories.
  (a) For the purpose of determining
compliance with § 141.21 through
141.27, 141.30, 141.40, 141.74, 141.89
and 141.402, samples may be
considered only if they have been
analyzed by a laboratory certified by the
State except that measurements of
alkalinity, calcium, conductivity,
disinfectant residual, orthophosphate,
pH, silica, temperature and turbidity
may be performed by any person
acceptable to the State.
*****
• 6. Section 141.153 is amended by
adding a new paragraph (h)(6j to read as
follows:

§141.153  Content of the reports.
*****
  (h)*  *  *
  (6) Systems required to comply with
subpart S. (i) Any ground water system
that receives notice from the State of a
significant deficiency or notice from a
laboratory of a fecal indicator-positive
ground water source sample that is not
invalidated by the State under
§ 141.402(d) must inform its customers
of any  significant deficiency that is
uncorrected at the time of the next
report  or of any fecal indicator-positive
ground water source sample in the next
report. The system must continue to
inform the public annually until the
State determines that particular
significant deficiency is corrected or the
fecal contamination in the ground water
source is addressed under § 141.403(a).
Each report must include the following
elements.
  (A) The nature of the particular
significant deficiency or the source of
the fecal contamination (if the source is
known) and the date the significant
deficiency was identified by the State or
the dates of the fecal indicator-positive
ground water source samples;
  (B)  If the fecal  contamination in the
ground water source has been addressed
under § 141.403(a) and  the date of such
action;
  (C)  For each significant deficiency or
fecal contamination in the ground water
source that has not been addressed
under § 141.403(a), the  State-approved
plan and schedule for correction,
including interim measures, progress to
date, and any interim measures
completed; and
  (D)  If the system receives notice of a
fecal indicator-positive ground water
source sample that is not invalidated by
the State under § 141.402(d), the
potential health effects  using the health
effects language of Appendix A of
subpart O.

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65652
Federal Register/Vol. 71, No.  216/Wednesday,  November 8, 2006/Rules and Regulations
  (ii) If directed by the State, a system
with significant deficiencies that have
been corrected  before the next report is
issued must inform its customers of the
significant deficiency, how the
                             deficiency was corrected, and the date
                             of correction under paragraph (h)(6)(i) of
                             this section.
                                        • 7. Appendix A to subpart O is
                                        amended by adding a new entry "Fecal
                                        Indicators (enterococci or coliphage)" to
                                        read as follows:
                        APPENDIX A TO SUBPART O OF PART 141—REGULATED CONTAMINANTS
    Contaminant (units)
                 Traditional
                MCL in mg/L
To convert for
CCR, multiply
     by
MCL in CCR
   units
MCLG
Major sources
  in drinking
    water
Health effects language
Microbiological Contaminants:
Fecal Indicators (enterococci
  or coliphage).
                                          TT
                           N/A .
                                                                     Human and
                                                                       animal fecal
                                                                       waste.
                                                       Fecal indicators are mi-
                                                        crobes whose presence
                                                        indicates that the water
                                                        may be contaminated with
                                                        human or animal wastes.
                                                        Microbes in these wastes
                                                        can cause short-term
                                                        health effects, such as di-
                                                        arrhea, 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 com-
                                                        promised immune sys-
                                                        tems.
  TT=Treatment Technique.


• 8. Section 141.202 is amended by
redesignating entry (8) in Table 1 in
paragraph (a) as entry (9); and adding a
new paragraph (8) to read as follows:

§141.202 Tier 1 Public Notice—Form,
manner, and frequency of notice.

  (a) *  * *

Table 1 to § 141.202—Violation
Categories and Other Situations
Requiring a Tier 1 Public Notice
*****

  (8) Detection of E. coli, enterococci, or
coliphage in source water samples as
                             specified in §
                             §141.402(b).
             141.402(a) and
                             • 9. Section 141.203 is amended by
                             adding entry (4) to Table 1 in paragraph
                             (a) to read as follows:

                             § 141.203  Tier 2 Public Notice—Form,
                             manner, and frequency of notice.
                               (a)*  *  *
                             Table 1  to § 141.203—Violation
                             Categories and  Other Situations
                             Requiring a Tier 2 Public Notice
                            (4) Failure to take corrective action or
                          failure to maintain at least 4-log
                          treatment of viruses (using inactivation,
                          removal, or a State-approved
                          combination of 4-log virus inactivation
                          and removal) before or at the first
                          customer under § 141.403(a).
                          *****

                          • 10. Appendix A to Subpart Q of Part
                          141 is amended to read as follows:
                          • a. Adding I.A.ll;
                          • b. Redesignating entry IV.F as entry
                          IV.G; and
                          • c. Adding a new entry IV.F in
                          alphabetical order:
 APPENDIX A TO SUBPART Q OF PART 141—NPDWR VIOLATIONS AND OTHER SITUATIONS REQUIRING  PUBLIC NOTICE 1
                                                                  MCL/MRDL/TT violations2
                          Contaminant
                                                                                     Monitoring and testing
                                                                                     procedure violations
                                                                Tier of public
                                                                notice required
                                                                      Citation
                                                     Tier of public
                                                    notice  required
                                                                                                  Citation
                            I. Violations of National Primary Drinking Water Regulations (NPDWR):3
                                             A. Microbiological Contaminants
11. Ground Water Rule violations
                                                                         141.404
                                                                                                  141.402(h).
                                                                                                  141.403(d).

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           Federal Register/Vol.  71, No.  216/Wednesday, November  8,  2006/Rules and Regulations    65653
APPENDIX A TO SUBPART Q OF PART 141—NPDWR VIOLATIONS AND OTHER SITUATIONS REQUIRING PUBLIC NOTICE 1—
                                                       Continued
                                                                    MCL/MRDLATT violations2
                          Contaminant
                                                         Monitoring and testing
                                                         procedure violations
                                                                  Tier of public
                                                                 notice required
                                          Citation
                              Tier of public
                             notice required
                                                                      Citation
                                       IV. Other Situations Requiring Public Notification
F. Source Water  Sample Positive  for GWR Fecal indicators:  E.
  enterococci, or coliphage 	
                   coli,
                                          141.402(g)
                                      N/A
                                                                             N/A
  1 Violations and other situations not listed in this table  (e.g., failure to prepare Consumer Confidence Reports) do not require notice, unless
otherwise determined by the primacy agency. Primacy agencies may, at their option, also require a more stringent public notice tier (e.g., Tier 1
instead of Tier 2 or Tier 2 instead of Tier 3) for specific violations and situations listed in this Appendix, as authorized under §141.202(a) and
§141.203(a).
  2MCL—Maximum contaminant level, MRDL—Maximum residual disinfectant level, TT—Treatment technique.
  3The term Violations of National Primary Drinking Water Regulations (NPDWR) is used here to include violations of MCL, MRDL, treatment
technique, monitoring, and testing procedure requirements.
                                         • 11. Appendix B of Subpart Qof'Part
                                         141 is amended by adding entries A.l.c:
                                         and A.l.d in numerical order to read as
                                         follows:
     APPENDIX B TO SUBPART Q OF PART 141—STANDARD HEALTH EFFECTS LANGUAGE FOR PUBLIC NOTIFICATION
                  Contaminant
          MCLG1
           mg/L
MCL2
mg/L
Standard health effects language for public notification
                                    National Primary Drinking Water Regulations (NPDWR)
                                              A. Microbiological Contaminants
1c. Fecal indicators (GWR):
    i. E. coli
    ii. enterococci
    iii. coliphage
1d. Ground Water Rule (GWR) TT violations
       Zero 	  TT
       None  	  TT
       None  	  TT
       None  	  TT
          Fecal indicators are microbes  whose presence indi-
            cates that  the  water  may be  contaminated with
            human or animal wastes. Microbes in these wastes
            can cause  short-term health  effects, such as diar-
            rhea,  cramps, nausea, headaches,  or other  symp-
            toms. They may pose a special health risk  for in-
            fants, young children, some of the elderly, and peo-
            ple with severely compromised immune systems.
          Inadequately treated or inadequately protected water
            may contain disease-causing organisms. These or-
            ganisms can cause symptoms  such  as diarrhea,
            nausea, cramps, and associated headaches.
  1 MCLG—Maximum contaminant level goal.
  2 MCL—Maximum contaminant level.
• 12. Appendix C to Subpart Q is
amended by adding the following
abbreviations in alphabetical order:

Appendix C to Subpart Q of Part 141-
List of Acronyms Used in Public
Notification Regulations
GWR Ground Water Rule
• 13. A new subpart S is added to read
as follows:
Subpart S—Ground Water Rule

Sot:.
141.400  General requirements and
    applicability.
141.401  Sanitary surveys tor ground water
    systems.
141.402  Ground water source microbial
    monitoring and analytical methods.
141.403  Treatment technique requirements
    for ground water systems.
141.404  Treatment technique violations for
    ground water systems.
141.405  Reporting and recordkeeping for
    ground water systems.
                 Subpart S—Ground Water Rule

                 § 141.400  General requirements and
                 applicability.
                   (a) Scope of this subpart. The
                 requirements of this subpart S constitute
                 National Primary Drinking Water
                 Regulations.
                   (b) Applicability. This subpart applies
                 to all public water systems that use
                 ground water except that it does not
                 apply to public water systems that
                 combine all of their ground water with
                 surface water or with ground water
                 under the direct influence of surface
                 water prior to treatment under subpart

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65654    Federal Register/Vol.  71, No. 216/Wednesday,  November 8, 2006/Rules and Regulations
H. For the purposes of this subpart,
"ground water system" is defined as any
public water system meeting this
applicability statement, including
consecutive systems receiving finished
ground water.
  (c) General requirements. Systems
subject to this subpart must comply
with the following requirements:
  (1) Sanitary survey information
requirements for all ground water
systems as described in § 141.401.
  (2) Microbial source water monitoring
requirements for ground water systems
that do not treat all of their ground
water to at least 99.99 percent (4-log)
treatment of viruses (using inactivation,
removal, or a State-approved
combination of 4-log virus inactivation
and removal) before or at the first
customer as described in § 141.402.
  (3) Treatment technique requirements,
described in § 141.403, that apply to
ground water systems that have  fecally
contaminated source waters, as
determined by source water monitoring
conducted under § 141.402, or that have
significant deficiencies that are
identified by the State or that are
identified by EPA under SDWA section
1445. A ground water system with
fecally contaminated source water or
with significant deficiencies subject to
the treatment technique requirements of
this subpart  must implement one or
more of the following corrective action
options: correct all significant
deficiencies; provide an alternate source
of water; eliminate the source of
contamination;  or provide treatment
that reliably achieves at least 4-log
treatment of viruses (using inactivation,
removal, or a State-approved
combination of 4-log virus inactivation
and removal) before or at the first
customer.
  (4) Ground water systems that provide
at least 4-log treatment of viruses (using
inactivation, removal, or a State-
approved combination of 4-log virus
inactivation  and removal) before or at
the first customer are required to
conduct compliance monitoring to
demonstrate treatment effectiveness, as
described in § 141.403(b).
  (5) If requested by the State, ground
water systems must provide the  State
with any existing information that will
enable the State to  perform a
hydrogeologic sensitivity assessment.
For the purposes of this subpart,
"hydrogeologic sensitivity assessment"
is a determination of whether ground
water systems obtain water from
hydrogeologically sensitive settings.
  (d) Compliance date. Ground water
systems must comply, unless otherwise
noted, with the  requirements of this
subpart beginning December 1, 2009.
§ 141.401  Sanitary surveys for ground
water systems.
  (a) Ground water systems must
provide the State, at the State's request,
any existing information that will
enable the State to conduct a sanitary
survey.
  (b) For the purposes of this subpart,
a "sanitary survey," as conducted by the
State, includes but is not limited to, an
onsite review of the water source(s)
(identifying sources of contamination by
using results of source water
assessments or other relevant
information where available), facilities,
equipment, operation, maintenance, and
monitoring compliance of a public
water system to evaluate the adequacy
of the system, its sources and operations
and the distribution of safe drinking
water.
  (c) The sanitary survey must include
an evaluation of the applicable
components listed in paragraphs (c)(l)
through (8) of this section:
  (1) Source,
  (2) Treatment,
  (3) Distribution system,
  (4) Finished water storage,
  (5) Pumps, pump facilities, and
controls,
  (6) Monitoring, reporting, and data
verification,
  (7) System management and
operation, and
  (8) Operator compliance with State
requirements.

§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)(l)(i) and (a)(l)(ii) of this section
exist.
  (i) The system does not provide at
least 4-log treatment of viruses (using
inactivation, removal, or a State-
approved combination of 4-log virus
inactivation and removal) before or at
the first customer for each ground water
source; and
  (ii) The system is notified that a
sample collected under § 141.21(a) is
total coliform-positive and the sample is
not invalidated under § 141.21(c).
  (2) Sampling Requirements. A ground
water system must collect, within  24
hours of notification of the total
coliform-positive sample, at least one
ground water source sample  from  each
ground water source in use at the time
the total coliform-positive sample was
collected under § 141.21(a), 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 § 14.1.21(a) and that
the system intends to use for
representative sampling under this
paragraph.
  (iii) A ground water system serving
1,000 people or fewer may use a repeat
sample collected from a ground water
source to  meet both the requirements of
§ 141.21(b) and to satisfy the monitoring
requirements of paragraph (a)(2) of this
section for that ground water  source
only if the State approves  the use of E.
coli as a fecal indicator for source water
monitoring under this paragraph (a). If
the repeat sample collected from the
ground water source is E.coli positive,
the system must comply with paragraph
(a)(3) of this section.
  (3) Additional Requirements. If the
State does not require corrective action
under § 141.403(a)(2) for a fecal
indicator-positive source water sample
collected  under paragraph (a)(2)  of this
section that is not invalidated under
paragraph (d) of this section, the system
must collect five additional source
water samples from the same  source
within 24 hours of being notified of the
fecal indicator-positive sample.
  (4) Consecutive and Wholesale
Systems, (i). In addition to the other
requirements of this  paragraph (a),  a
consecutive ground water system that
has a total coliform-positive sample
collected  under § 141.21(a) must notify
the wholesale system(s) within 24 hours
of being notified of the total coliform-
positive sample.
  (ii) In addition to the other
requirements of this  paragraph (a), a
wholesale ground water system must
comply with paragraphs (a)(4)(ii)(A) and
(a)(4)(ii)(B) of this section.
  (A) A wholesale ground water system
that receives notice from a consecutive
system it serves that  a sample collected
under § 141.21(a) 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

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                                                                        65655
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 hy that
ground water source of the fecal
indicator source water positive within
24 hours of heing notified of the ground
water source sample monitoring result
and must meet the requirements of
paragraph (a)(3) of this section.
  (5) Exceptions to the Triggered Source
Water Monitoring Requirements. A
ground water system is not required to
comply with the source water
monitoring requirements of paragraph
(a) of this section if either of the
following conditions exists:
  (i) The State determines, and
documents in writing, that the total
coliform-positive sample collected
under § 141.21(a) is caused by a
distribution system deficiency; or
  (ii) The total coliform-positive sample
collected under § 141.21(a) is collected
at a location that meets State criteria for
distribution system conditions that will
cause total coliform-positive samples.
  (b) Assessment Source Wafer
Monitoring. If directed by the State,
ground water systems must conduct
assessment source water monitoring that
meets State-determined requirements
for such monitoring. A ground water
system conducting assessment source
water monitoring may use a triggered
source water sample collected under
paragraph (a)(2) of this section to meet
the requirements of paragraph (b) of this
section. State-determined assessment
source water monitoring requirements
may include:
  (1) Collection of a total of 12 ground
water source samples that represent
each month the system provides ground
water to the public,
  (2) Collection of samples from each
well unless the system obtains written
State approval to conduct monitoring at
one or more wells within the ground
water system that are representative of
multiple wells  used by that system and
that draw water from the same
hydrogeologic setting,
  (3) Collection of a standard sample
volume of at least 100 mL for fecal
indicator analysis regardless of the fecal
indicator or analytical method used,
  (4) Analysis of all ground water
source samples using one of the
analytical methods listed in the in
paragraph (c)(2) of this section for the
presence of E. coli, enterococci, or
coliphage,
  (5) Collection of ground water source
samples at a location prior to any
treatment of the ground water source
unless the State approves a sampling
location after treatment, and
  (6) Collection of ground water source
samples at the well itself unless the
system's configuration does not allow
for sampling at the well itself and the
State approves an alternate sampling
location that is representative of the
water quality of that well.
  (c) Analytical methods. (1) A ground
water system subject to the source water
monitoring requirements of paragraph
(a) of this section must collect a
standard sample volume of at least 100
mL for fecal indicator analysis
regardless of the fecal indicator or
analytical method used.
  (2) A ground water system must
analyze all ground water source samples
collected under paragraph (a) of this
section using one of the analytical
methods listed in the following table in
paragraph (c)(2) of this section for the
presence of E. coli, enterococci, or
coliphage:
                                ANALYTICAL METHODS FOR SOURCE WATER MONITORING
               Fecal indicator1
                    Methodology
                 Method citation
E. coli.
Enterococci
Coliphage
    Colilert3 	
    Colisure3 	
    Membrane Filter Method with Ml Agar 	
    m-ColiBlue24 Test5 	
    E*Colite Test6 	
    EC-MUG7 	
    NA-MUG7 	
    Multiple-Tube Technique	
    Membrane Filter Technique 	
    Enterolert9	
    Two-Step Enrichment  Presence-Absence  Proce-
      dure.
    Single Agar Layer Procedure	
       9223 B.2
       9223 B.2
       EPA Method 1604.4
       9221 F.2
       9222 G.2
       9230B.2
       EPA Method 1600.8

       EPA Method 1601.10

       EPA Method 1602.11
  Analyses must be conducted in accordance with the documents listed below. The Director of the Federal Register approves the incorporation
by reference of the documents listed in footnotes 2-11 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. Copies may be inspected 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/federaLregister/
code_of_federal_regulations/ibrJocations.html.
  1 The time from sample collection to initiation of analysis may not exceed 30 hours. The ground water system is encouraged but is not required
to hold samples below 10°C during transit.
  2 Methods are described in Standard Methods for the Examination of Water and  Wastewater 20th edition (1998) and copies may be obtained
from the American Public Health Association, 1015 Fifteenth  Street, NW., Washington, DC 20005-2605.
  3Medium is available through IDEXX Laboratories, Inc., One IDEXX Drive, Westbrook, Maine 04092.
  4 EPA Method 1604: Total Conforms and Escherichia coli in Water by Membrane  Filtration Using a Simultaneous Detection Technique (Ml Me-
dium); September 2002, EPA 821-R-02-024. 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 A description of the  m-ColiBlue24 Test, "Total Coliforms and E. coli Membrane Filtration Method with m-ColiBlue24® Broth," Method No.
10029 Revision  2, August 17,  1999, is available from Hach Company, 100 Dayton Ave., Ames, IA  50010 or from EPA's Water Resource  Center
(RC-4100T), 1200 Pennsylvania Avenue, NW., Washington,  DC 20460.
  6 A description of the E*Colite Test, "Charm E*Colite Presence/Absence Test for Detection and Identification of Coliform Bacteria and Esch-
erichia coli in Drinking Water, January 9, 1998,  is available from Charm Sciences, Inc., 659 Andover St., Lawrence, MA 01843-1032 or from
EPA's Water Resource Center (RC-4100T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
  7EC-MUG (Method 9221F) or NA-MUG (Method 9222G) can be used for E. contesting step as described in § 141.21(f)(6)(i) or (ii) after use
of Standard  Methods 9221 B, 9221 D, 9222 B, or 9222 C.

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Federal Register/Vol. 71, No. 216/Wednesday,  November 8, 2006/Rules  and  Regulations
  8 EPA Method 1600: Enterococci in Water by Membrane Filtration Using membrane-Enterococcus Indoxyl-p-D-Glucoside Agar (mEI) EPA
821-R-02-022 (September 2002) is an approved variation of Standard Method 9230C. The method is available at http://www.epa.gov/nerlcwww/
1600sp02.pdf or from EPA's Water Resource Center (RC-4100T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. The holding time
and temperature for ground water samples are specified in footnote 1 above, rather than as specified in Section 8 of EPA Method 1600.
  9 Medium is available through IDEXX Laboratories, Inc., One  IDEXX Drive, Westbrook, Maine 04092. Preparation and use of the medium is set
forth in the article "Evaluation of Enterolert for Enumeration of  Enterococci in Recreational Waters," by Budnick, G.E., Howard, R.T., and Mayo,
D.R., 1996, Applied and Environmental Microbiology, 62:3881-3884.
  10EPA Method 1601: Male-specific (F+) and Somatic Coliphage in Water by Two-step Enrichment Procedure; April 2001, EPA 821-R-01-030.
Method is available at http://www.epa.gov/nerlcwww/1601ap01.pdf or from EPA's Water Resource Center (RC-4100T), 1200 Pennsylvania Ave-
nue, NW., Washington, DC 20460.
  11 EPA Method 1602: Male-specific (F+) and Somatic Coliphage in Water by Single Agar Layer (SAL) Procedure; April 2001, EPA 821-R-01-
029. Method is available at http://www.epa.gov/nerlcwww/1602ap01.pdfor from  EPA's Water Resource Center (RC-4100T),  1200 Pennsylvania
Avenue, NW., Washington, DC 20460.
  (d) Invalidation of a fecal indicator-
positive ground water source sample. (1)
A ground water system may obtain State
invalidation of a fecal indicator-positive
ground water source sample collected
under paragraph (a) of this section only
under the conditions specified in
paragraphs (d)(l)(i) and (ii) of this
section.
  (i) The system provides the State with
written notice from the laboratory that
improper sample analysis occurred; or
  (ii) The State determines and
documents in writing that there is
substantial evidence that a fecal
indicator-positive ground water source
sample is not related to source water
quality.
  (2) If the  State invalidates a fecal
indicator-positive ground water source
sample, the ground water system  must
collect another source water sample
under paragraph (a) of this section
within 24 hours of being notified  by the
State of its invalidation decision and
have it analyzed for the same fecal
indicator using the analytical methods
in paragraph (c) of this section. The
State may extend the 24-hour time limit
on a case-by-case basis if the system
cannot collect the 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.
  (e) Sampling location. (I) Any ground
water source sample  required under
paragraph (a) of this section must be
collected at a location prior to any
treatment of the ground water source
unless the State approves a sampling
location after treatment.
  (2) If the  system's configuration does
not allow for sampling at the well itself,
the system  may collect a sample at a
State-approved location to meet the
requirements of paragraph (a) of this
section if the sample is representative of
the water quality of that well.
  (f) New Sources. If directed by the
State, a ground water system that  places
a new ground water source into service
after November 30, 2009, must conduct
assessment source water monitoring
under paragraph (b) of this section. If
                             directed by the State, the system must
                             begin monitoring before the ground
                             water source is used to provide water to
                             the public.
                               (g) Public Notification. A ground
                             water system with a ground water
                             source sample collected under
                             paragraph (a) or (b) of this section that
                             is fecal indicator-positive and that is not
                             invalidated under paragraph (d) of this
                             section, including consecutive systems
                             served by the ground water source, must
                             conduct public: notification under
                             §141.202.
                               (h) Monitoring Violations. Failure to
                             meet the requirements of paragraphs
                             (a)-(f) of this section is a monitoring
                             violation and requires the ground water
                             system to provide  public notification
                             under §141.204.

                             §141.403 Treatment technique
                             requirements for ground water systems.
                               (a) Ground water systems with
                             significant deficiencies or source water
                             fecal contamination.
                               (I) The treatment technique
                             requirements of this section must be met
                             by ground water systems when  a
                             significant deficiency is identified or
                             when a ground water source sample
                             collected under § 141.402(a)(3)  is fecal
                             indicator-positive.
                               (2) If directed by the State, a ground
                             water system with a ground water
                             source sample collected under
                             § 141.402(a)(2), § 141.402(a)(4),  or
                             §141.402(b) that is fecal indicator-
                             positive must comply with the
                             treatment technique requirements of
                             this section.
                               (3) When a significant deficiency is
                             identified at a Subpart H public water
                             system that uses both ground water and
                             surface water or ground water under the
                             direct influence of surface water, the
                             system must comply with provisions of
                             this paragraph except in cases where the
                             State determines that the significant
                             deficiency is in a portion of the
                             distribution system that is served solely
                             by surface water or ground water under
                             the direct influence of surface water.
                               (4) Unless the State directs the ground
                             water system to implement a specific
                             corrective action, the ground water
                             system must consult with the State
regarding the appropriate corrective
action within 30 days of receiving
written notice from the State of a
significant deficiency, written notice
from a laboratory that a ground water
source sample collected under
§ 141.402(a)(3) was found to be fecal
indicator-positive, or direction from the
State that a fecal indicator'positive
collected under § 141.402(a)(2),
§ 141.402(a){4), or § 141.402(b) requires
corrective action. For the purposes of
this subpart, significant deficiencies
include,  but are not limited to, defects
in design, operation, or maintenance, or
a failure  or malfunction of the sources,
treatment, storage, or distribution
system that the State determines to be
causing,  or have potential for causing,
the introduction of contamination into
the water delivered to consumers.
  (5) Within 120 days (or earlier if
directed  by the State) of receiving
written notification from the State of a
significant deficiency, written notice
from a laboratory that a ground water
source sample collected under
§ 141.402(a)(3) was found to be fecal
indicator-positive, or direction from the
State that a fecal indicator-positive
sample collected under § 141.402(a)(2),
§ 141.402(a)(4), or § 141.402(h) requires
corrective action, the ground water
system must either:
  (i) Have completed corrective action
in accordance with applicable State
plan review processes or other State
guidance or direction, if any, including
State-specified interim measures; or
  (ii) Be  in compliance with a State-
approved corrective action plan and
schedule subject to the conditions
specified in paragraphs (a)(5)(ii)(A) and
(a)(5)(ii)(B) of this section.
  (A)  Any subsequent modifications to
a State-approved corrective action plan
and schedule must  also be approved by
the State.
  (B) If the State specifies interim
measures for protection of the public
health pending State approval of the
corrective action plan and schedule or
pending  completion of the corrective
action plan, the system must comply
with these interim measures as well as

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           Federal Register/Vol.  71, No. 216/Wednesday,  November 8, 2006/Rules and Regulations   65657
with any schedule specified by the
State.
  (6) Corrective Action Alternatives.
Ground water systems that meet the
conditions of paragraph (a)(l) or (a)(2) of
this section must implement one or
more of the following corrective action
alternatives:
  (i) Correct all significant deficiencies;
  (ii) Provide an alternate source of
water;
  (iii) Eliminate the source of
contamination; or
  (iv) Provide treatment that reliably
achieves at least 4-log treatment of
viruses (using inactivation,  removal, or
a State-approved combination of 4-log
virus inactivation and removal) before
or at the first customer  for the ground
water source.
  (7) Special notice to the public of
significant deficiencies or source water
fecal contamination, (i) In addition to
the applicable public notification
requirements of § 141.202, a community
ground water system that receives
notice from the State of a significant
deficiency or notification of a fecal
indicator-positive ground water source
sample that is not invalidated by the
State under § 141.402(d) must inform
the public served  by the water system
under § 141.153(h)(6) of the fecal
indicator-positive source sample or of
any significant deficiency that has not
been corrected. The system must
continue to inform the  public annually
until the significant deficiency is
corrected or the fecal contamination in
the ground water source is determined
by the State to be corrected  under
paragraph (a)(5) of this section.
  (ii) In addition to the applicable
public notification requirements of
§ 141.202, a non-community ground
water system that receives notice from
the State of a significant deficiency must
inform the public served by the water
system in a manner approved by the
State 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
system must continue to inform the
public annually until the significant
deficiency is corrected. The information
must include:
  (A) The nature of the significant
deficiency and the date the significant
deficiency was identified by the State;
  (B) The State-approved plan and
schedule for correction of the significant
deficiency, including interim measures,
progress to date, and any interim
measures completed; and
  (C) For systems with a large
proportion of non-English speaking
consumers, as determined by the State,
information in the appropriate
language(s) regarding the importance of
the notice or a telephone number or
address where consumers may contact
the system to obtain a translated copy of
the notice or assistance in the
appropriate language.
  (iii) If directed by the State, a non-
community water system with
significant deficiencies that have been
corrected must inform its customers of
the significant deficiencies, how the
deficiencies were corrected, and the
dates of correction under paragraph
(a)(7)(ii) of this section.
  (b) Compliance n}onitoring—(1)
Existing ground water sources. A ground
water system that is not required to
meet the source water monitoring
requirements of this subpart for any
ground water source because it provides
at least 4-log treatment of viruses (using
inactivation, removal, or a State-
approved combination of 4-log virus
inactivation and removal) before or at
the first customer for any ground water
source before December 1, 2009, must
notify the  State in writing that it
provides at least 4-log treatment of
viruses (using inactivation, removal, or
a State-approved combination of 4-log
virus inactivation and removal) before
or at the first customer for the specified
ground water source and begin
compliance monitoring in accordance
with paragraph (b)(3) of this section by
December 1, 2009. Notification to the
State must include engineering,
operational, or other information that
the State requests to evaluate the
submission. If the system subsequently
discontinues 4-log treatment of viruses
(using inactivation, removal, or a State-
approved combination of 4-log virus
inactivation and removal) before or at
the first customer for a ground water
source, the system must conduct ground
water source monitoring as required
under §141.402.
  (2) New ground water sources. A
ground water system that places a
ground water source in service after
November 30, 2009, that is not required
to meet the source water monitoring
requirements of this subpart because the
system provides at least 4-log treatment
of viruses  (using inactivation, removal,
or a State-approved combination of 4-
log virus inactivation and removal)
before or at the first customer for the
ground water source must comply with
the requirements of paragraphs (b)(2)(i),
(b)(2)(ii) and (b)(2)(iii) of this section.
  (i) The system must notify the State in
writing that it provides at least 4-log
treatment of viruses (using inactivation,
removal, or a State-approved
combination of 4-log virus inactivation
and removal) before or at the first
customer for the ground water source.
Notification to the State must include
engineering, operational, or other
information that the State requests to
evaluate the submission.
  (ii) The system must conduct
compliance monitoring as required
under § 141.403(b)(3) of this subpart
within 30 days of placing the source in
service.
  (iii) The system must conduct ground
water source monitoring under
§141.402 if the system subsequently
discontinues 4-log treatment of viruses
(using inactivation, removal, or a State-
approved combination of 4-log virus
inactivation and removal) before or at
the first customer for the ground water
source.
  (3) Monitoring requirements. A
ground water system subject to the
requirements of paragraphs (a), (b)(l) or
(b)(2)  of this section must monitor the
effectiveness and reliability of treatment
for that ground water source before or  at
the first customer as follows:
  (i) Chemical disinfection—(A) Ground
water systems serving greater than 3,300
people. A ground water  system that
serves greater than 3,300 people must
continuously monitor the residual
disinfectant concentration using
analytical methods specified in
§ 141.74(a)(2) at a location approved by
the State and must record the lowest
residual disinfectant concentration each
day that water from the ground water
source is served to the public. The
ground water system must maintain the
State-determined residual disinfectant
concentration every day the ground
water system serves water from the
ground water source to the public. If
there is a failure in the continuous
monitoring equipment, the ground
water system must conduct grab
sampling every four hours until the
continuous monitoring equipment is
returned to service. The system must
resume continuous residual disinfectant
monitoring within 14 days.
  (B) Ground water systems serving
3,300 or fewer people. A ground water
system that serves 3,300 or fewer people
must monitor the residual disinfectant
concentration using analytical methods
specified in § 141.74(a)(2) at a location
approved by the State and record the
residual disinfection concentration each
day that water from the ground water
source is served to the public. The
ground water system must maintain the
State-determined residual disinfectant
concentration every day the ground
water system serves water from the
ground water source to the public. The
ground water system must take a daily
grab sample during the hour of peak
flow or at another time specified by the
State. If any daily grab sample

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65658    Federal  Register/Vol.  71,  No. 216/Wednesday,  November 8, 2006/Rules and Regulations
measurement falls below the State-
determined residual disinfectant
concentration, the ground water system
must take follow-up samples every four
hours until the residual disinfectant
concentration is restored to the State-
determined level. Alternatively, a
ground water system that serves 3,300
or fewer people may monitor
continuously and meet the requirements
of paragraph (b)(3)(i)(A) of this section.
  (ii) Membrane filtration. A ground
water system that uses membrane
filtration to meet the requirements of
this subpart must monitor the
membrane filtration process in
accordance with all State-specified
monitoring requirements and must
operate the membrane filtration in
accordance with all State-specified
compliance requirements. A ground
water system that uses membrane
filtration is in compliance with the
requirement to achieve at least 4-log
removal of viruses when:
  (A) The membrane has an absolute
molecular weight cut-off (MWCO), or an
alternate parameter that describes the
exclusion characteristics of the
membrane, that can reliably achieve at
least 4-log removal of  viruses;
  (B) The membrane process is operated
in accordance with State-specified
compliance requirements; and
  (C) The integrity of the membrane is
intact.
  (iii) Alternative treatment. A ground
water system that uses a State-approved
alternative treatment to meet the
requirements of this subpart by
providing at least 4-log treatment of
viruses (using inactivation, removal, or
a State-approved combination of 4-log
virus inactivation and removal) before
or at the first customer must:
  (A) Monitor the alternative treatment
in accordance with all State-specified
monitoring requirements; and
  (B) Operate the alternative treatment
in accordance with all compliance
requirements that the  State determines
to be necessary to'achieve at least 4-log
treatment of viruses.
  (c) Discontinuing treatment. A ground
water system may discontinue 4-log
treatment of viruses (using inactivation,
removal,  or a State-approved
combination of 4-log virus inactivation
and removal) before or at the first
customer for a ground water source if
the State  determines and documents in
writing that 4-log treatment of viruses is
no longer necessary for that ground
water source. A system that
discontinues 4-log treatment of viruses
is subject to the source water monitoring
and analytical methods requirements of
§ 141.402 of this subpart.
  (d) Failure to meet the monitoring
requirements of paragraph (b) of this
section is a monitoring violation and
requires the ground water system to
provide public: notification under
§141.204.

§ 141.404 Treatment technique violations
for ground water systems.
  (a) A ground water system with a
significant deficiency is in violation of
the treatment technique requirement if,
within 120 days (or earlier if directed by
the State) of receiving written notice
from the State of the significant
deficiency, the system:
  (1) Does not complete corrective
action  in accordance with any
applicable State plan review processes
or other State guidance and direction,
including State specified interim actions
and measures, or
  (2) Is not in compliance with a State-
approved corrective action plan and
schedule.
  (b) Unless the State invalidates a fecal
indicator-positive ground water source
sample under § 141.402(d), a ground
water system is in violation of the
treatment technique requirement if,
within 120 days (or earlier if directed by
the State) of meeting the conditions of
§ 141.403(a)(l) or § 141.403(a)(2), the
system:
  (1) Does not complete corrective
action  in accordance with any
applicable State plan review processes
or other State guidance and direction,
including State-specified interim
measures, or
  (2) Is not in compliance with a State-
approved corrective action plan and
schedule.
  (c) A ground water system subject to
the requirements of § 141.403(b)(3) that
fails to maintain at least 4-log treatment
of viruses (using inactivation, removal,
or a State-approved combination of 4-
log  virus inactivation and removal)
before  or at the first customer for a
ground water source is in violation of
the treatment technique requirement if
the failure is not corrected within four
hours of determining the system is not
maintaining at least 4-log treatment of
viruses before or at the first customer.
  (d) Ground water system must give
public  notification under § 141.203 for
the treatment technique violations
specified in paragraphs (a),  (b) and (c)
of this  section.

§141.405  Reporting and recordkeeping for
ground water systems.
  (a) Reporting. In addition to the
requirements of § 141.31, a ground
water system regulated under this
subpart must provide the following
information to the State:
  (1) A ground water system conducting
compliance monitoring under
§ 141.403(b) must notify the State any
time the system fails to meet any State-
specified requirements including, but
not limited to, minimum residual
disinfectant concentration, membrane
operating criteria or membrane integrity,
and alternative treatment operating
criteria, if operation in accordance with
the criteria or requirements is not
restored within four hours. The ground
water system must notify the State as
soon as possible, but in no case later
than the end of the next business day.
  (2) After completing any corrective
action under § 141.403(a), a ground
water system must notify the State
within 30 days of completion of the
corrective action.
  (3) If a ground water system subject to
the requirements of § 141.402(a) does
not conduct source water monitoring
under § 141.402(a)(5)(ii), the system
must provide documentation to the
State within 30 days of the total
coliform positive sample that it met the
State criteria.
  (b) Recordkeeping. In addition to the
requirements of § 141.33, a ground
water system regulated under this
subpart must maintain the following
information in its records:
  (1) Documentation of corrective
actions. Documentation shall be kept for
a period of not less than ten years.
  (2) Documentation of notice to the
public as required under § 141.403(a)(7).
Documentation shall be kept for a
period of not less than three years.
  (3) Records of decisions under
§ 141.402(a)(5)(ii) and records of
invalidation of fecal indicator-positive
ground water source  samples under
§141.402(d). Documentation shall  be
kept for a period of not less than five
years.
  (4) For consecutive systems,
documentation of notification to the
wholesale system(s) of total-coliform
positive samples that are not invalidated
under § 141.21 (c). Documentation shall
be kept for a period of not less than five
years.
  (5) For systems, including wholesale
systems, that are required  to perform
compliance monitoring under
§141.403(b):
  (i)  Records of the State-specified
minimum disinfectant residual.
Documentation shall be kept for a
period of not less than ten years.
  (ii) Records of the lowest daily
residual disinfectant  concentration and
records of the date and duration of any
failure to maintain the State-prescribed
minimum residual disinfectant
concentration for a period of more than

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           Federal Register/Vol.  71,  No. 216/Wednesday, November 8, 2006/Rules and Regulations    65659
four hours. Documentation shall be kept
for a period of not less than five years.
  (iii) Records of State-specified
compliance requirements for membrane
filtration and of parameters specified by
the State for State-approved alternative
treatment and records of the date and
duration of any failure to meet the
membrane operating, membrane
integrity, or alternative treatment
operating requirements for more than
four hours. Documentation shall be kept
for a period of not less than five years.

PART 142—NATIONAL PRIMARY
DRINKING WATER REGULATIONS
IMPLEMENTATION

• 14. The authority citation for part 142
continues to read as follows:
  Authority: 42 U.S.C. 300f. 300g-l, 300g-2,
3()0g-:i, 300g-4, 300g-5. 300g-6, 3UOJ-4,
300J-9, and 300J-11.

• 15. Section 142.14 is amended by
adding paragraph (d)(17) to read as
follows:

§ 142.14   Records kept by States.
*****
  (d)*  *  *
  (17) Records of the currently
applicable or most recent State
determination, including all supporting
information and an explanation of the
technical basis of each decision, made
under the following provisions of 40
CFR part 141, subpart S and 40 CFR part
142.
  (i) Section 142.16(o)(2)(v). Records of
written notices of significant
deficiencies.
  (ii) Section 141.403(a)(5)(ii) of this
chapter. Records of corrective action
plans, schedule approvals, and State-
specified interim measures.
  (iii) Section 142.16(o)(4). Records of
confirmations under § 141.403(a) of this
chapter that a significant deficiency has
been corrected or the fecal
contamination in the ground water
source has been addressed.
  (iv) Section 141.402(a)(5) of this
chapter. Records of State determinations
and records of ground water system's
documentation for not conducting
triggered source water monitoring.
  (v) Section 141.402(d) of this chapter.
Records of invalidations of fecal
indicator-positive ground water source
samples.
  (vi) Section 141.402(a)(2)(ii)  of this
chapter. Records of State approvals of
source water  monitoring plans,
  (vii) Section 142.16(o)(4)(ii). Records
of notices of the minimum residual
disinfection concentration (when using
chemical disinfection) needed  to
achieve at least 4-log virus inactivation
before or at the first customer.
  (viii) Sections 142.16(o)(4)(iv) and
142.16(o)(4)(v) Records of notices of the
State-specified monitoring and
compliance requirements (when using
membrane filtration or alternative
treatment) needed to achieve at least 4-
log treatment of viruses (using
inactivation, removal, or a State-
approved combination of 4-log
inactivation and removal) before  or at
the first customer.
  (ix) Sections 141.403(b)(l) and
141.403(b)(2) of this chapter. Records of
written notices  from the ground water
system that it provides at least 4-log
treatment of viruses (using inactivation,
removal, or a State-approved
combination of 4-log virus inactivation
and removal) before or at  the first
customer for a ground water source.
  (x) Section  142.16(o)(4)(vi). Records of
written determinations that the ground
water system may discontinue 4-log
treatment of viruses (using inactivation,
removal, or a State-approved
combination of 4-log inactivation and
removal).
*****

• 16. Section  142.15 is amended by
adding paragraph (c)(7) to read as
follows:

§142.15   Reports by States.
  (7) Ground water rule, (i) Sanitary
surveys. The month and year in which
the most recent sanitary survey was
completed or, for a State that uses a
phased review process, the date the last
element of the applicable eight elements
was evaluated under § 142.1B(o)(2) for
each ground water system.
  (ii) Corrective action requirements.
For any corrective action under
§ 141.403(a) of this chapter, the date the
ground water system completed
corrective action.
  (iii) Compliance monitoring. All
ground water systems providing at least
4-log treatment of viruses (using
inactivation, removal, or a State-
approved combination of 4-log virus
inactivation and removal) before or at
the first customer for any ground water
source(s).
*****

• 17. Section  142.16 is amended as
follows:
• a. Revise paragraph (a)(2)(iii), and
• b. Add paragraph (o) to read as
follows:

§ 142.16   Special primacy requirements.
  (a)*  *  *
  (2)* *  *
  (iii) Table 1 of 40 CFR 141.202(a)
(Items (5), (6), and (9))—To require
public water systems to give a Tier 1
public notice (rather than a Tier 2 or
Tier 3 notice) for violations or situations
listed in Appendix A of Subpart Q of
Part 141 of this chapter;
  (o) Requirements for States to adopt
40 CFR part 141, subpart S. In addition
to the general primacy requirements
specified elsewhere in this part,
including the requirement that State
regulations are no less stringent than the
Federal requirements, an application for
approval of a State program revision
that adopts 40 CFR part 141, subpart S,
must contain the information specified
in this paragraph (o).
  (1) Legal authority. The application
for  primacy  must demonstrate the State
has:
  (i) The authority contained in statute
or regulation to ensure that ground
water systems conduct source water
monitoring under § 141.402(a)(2),
§ 141.402(a)(3) and § 141.402(a)(4)(ii)(A)
of this chapter.
  (ii) The authority contained in  statute
or regulation to ensure that ground
water systems take the appropriate
corrective actions including interim
measures, if necessary, needed to
address significant deficiencies.
  (iii) The authority contained in statute
or regulation to ensure that ground
water systems take the appropriate
corrective actions, including interim
measures if necessary, to address anv
source water fecal contamination
identified during source water
monitoring under § 141.402 of this
chapter.
  (iv) The authority contained in statute
or regulation to ensure that ground
water systems consult with the State
regarding corrective action(s).
  (2) State practices or procedures for
sanitary surveys. In addition to the
general requirements for sanitary
surveys contained in § 142.10(b)(2), a
primacy application must describe how
the State will implement a sanitary
survey program that meets the
requirements of paragraph (o)(2)(i) of
this section. A "sanitary survey," as
conducted by the State, includes but is
not limited to, an onsite review of the
water source(s) (identifying sources of
contamination by using results of source
water assessments or other relevant
information where available), facilities,
equipment, operation, maintenance, and
monitoring compliance of a public
water system to evaluate the adequacy
of the system, its sources and operations
and the distribution of safe drinking
water.
  (i) The State must conduct sanitary
surveys that address the eight sanitary
survey components listed in this section
no less frequently than every three years

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65660    Federal  Register/Vol.  71,  No. 216/Wednesday,  November 8, 2006/Rules and Regulations
for community water systems, except as
provided in paragraph (o)(2)(iii) of this
section, and every five years for non-
community water systems. The State
may conduct more frequent sanitary
surveys for any system. The initial
sanitary survey for each community
water system must be  conducted by
December 31, 2012, unless the system
meets the requirements of paragraph
(o)(2)(iii) of this section. The initial
sanitary survey for each community
water system that meets the
requirements of paragraph (o)(2)(iii) of
this section and for each non-
community water system must be
conducted by December 31, 2014. The
sanitary survey must include an
evaluation of each of the following
elements as applicable:
  (A) Source,
  (B) Treatment,
  (C) Distribution system,
  (D) Finished water storage,
  (E) Pumps, pump facilities, and
controls,
  (F) Monitoring, reporting, and data
verification,
  (G) System management and
operation, and
  (H) Operator compliance with State
requirements.
  (ii) The State may use a phased
review process to meet the requirements
of (o)(2)(i) of this section if all the
applicable elements of paragraphs
(o)(2)(i)(A) through (o)(2)(i)(H) of this
section are evaluated within the
required interval.
  (iii) The State may conduct sanitary
surveys once every five years for
community water systems if the system
either provides at least 4-log treatment
of viruses (using inactivation, removal,
or a State-approved combination of
4-log inactivation and removal) before
or at the first customer for all its ground
water sources, or if it has an outstanding
performance record, as determined by
the State and documented in previous
sanitary surveys and has no history of
total coliform MCL or  monitoring
violations under § 141.21 of this chapter
since the last sanitary  survey. In its
primacy application, the State must
describe how it will determine whether
a community water system has an
outstanding performance record.
  (iv) The State must define and
describe in its primacy application at
least one specific significant deficiency
in each of the eight sanitary survey
elements in paragraphs (o)(2)(i)(A)
through (o)(2)(i)(H) of this section.
Significant deficiencies include, but are
not limited to, defects in design,
operation, or maintenance, or a failure
or malfunction of the sources, treatment,
storage, or distribution system that the
State determines to be causing, or have
potential for causing, the introduction of
contamination into the water delivered
to consumers.
  (v) As a condition of primacy, the
State must provide ground water
systems with written notice describing
any significant deficiencies no later than
30 days after the State identifies the
significant deficiency. The notice  may
specify corrective actions and deadlines
for completion of corrective actions. The
State may provide the written notice at
the time of the sanitary survey.
  (3) State practices or procedures for
source water microbial monitoring. The
State's primacy application must
include a description of the following:
  (i) The criteria the State will use
under §§ 141.402(a)(2)(i) and
141.402(d)(2) of this chapter for
extending the 24-hour time limit for a
system to collect a ground water source
sample to comply with the source water
monitoring requirements.
  (ii) The criteria the State will use
under §§ 141.402(a)(5)(i) and
141.402(a)(5)(ii) of this chapter to
determine whether the cause of the total
coliform-positive sample taken under
§ 141.21(a) of this chapter is directly
related to the distribution system.
  (iii) The criteria the State will use for
determining whether to invalidate a
fecal indicator-positive ground water
source sample under § 141.402(d)(l)(ii)
of this chapter.
  (iv) The criteria the State will use to
allow source water microbial
monitoring at a location after treatment
under § 141.402(e)(l) of this chapter.
  (4) State practices or procedures for
treatment technique requirements. As a
condition of primacy, the State must
verify that significant deficiencies or
source water fecal contamination have
been addressed. The State must verify
within 30 days after the ground water
system has reported to the State that it
has completed corrective action. The
State must verify either through written
confirmation from the ground water
system or a site visit by the State.
Written notice from the ground water
system under § 141.405(a)(2) of this
chapter may serve as this verification.
The State's primacy application must
include the following:
  (i) The process the State will use to
determine that a ground water system
achieves at least a  4-log treatment of
viruses (using inactivation, removal, or
a combination of inactivation and
removal) before or at the first customer
for a ground water source for systems
that are not subject to the source water
monitoring requirements of § 141.402(a)
of this chapter because the ground water
system has informed the State  that it
provides at least 4-log treatment of
viruses.
  (ii) The process the State will use to
determine the minimum residual
disinfectant concentration the  system
must provide prior to the first customer
for systems using chemical disinfection.
  (iii) The State-approved alternative
technologies that ground water systems
may use alone or in combination with
other approved technologies to achieve
at least 4-log treatment of viruses (using
inactivation, removal, or a State-
approved combination of 4-log
inactivation and removal) before or  at
the first customer for a ground water
source.
  (iv) The monitoring and compliance
requirements the State will require for
ground water systems treating  to at least
4-log treatment of viruses (using
inactivation, removal, or a State-
approved combination of inactivation
and removal) before or at the first
customer for State-approved alternative
treatment technologies.
  (v) The monitoring, compliance and
membrane integrity testing requirements
the State will require to demonstrate
virus removal for ground water systems
using membrane filtration technologies.
  (vi) The criteria, including public
health-based considerations and
incorporating on-site investigations and
source water monitoring results the
State will use to determine  if a ground
water system may  discontinue 4-log
treatment of viruses (using inactivation,
removal, or a State-approved
combination of inactivation and
removal) before or at the first customer.
[FR Dot;. 06-8763 Filed 11-7-06; 8:45 am]
BILLING CODE 6560-50-P

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