[Federal Register Volume 71, Number 216 (Wednesday, November 8, 2006)]
[Rules and Regulations]
[Pages 65574-65660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8763]
[[Page 65573]]
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Part II
Environmental Protection Agency
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40 CFR Parts 9, 141, and 142
National Primary Drinking Water Regulations: Ground Water Rule; Final
Rule
Federal Register / Vol. 71, No. 216 / Wednesday, November 8, 2006 /
Rules and Regulations
[[Page 65574]]
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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.
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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:
[email protected]. For general information, contact the Safe
Drinking Water Hotline, telephone number: (800) 426-4791. The Safe
Drinking Water Hotline is open Monday through Friday, excluding legal
holidays, from 10 a.m. to 4 p.m. Eastern time.
SUPPLEMENTARY INFORMATION:
I. General Information
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:
------------------------------------------------------------------------
Examples of regulated
Category entities
------------------------------------------------------------------------
Industry.................................. Public ground water systems.
State, Local, Tribal or Federal Public ground water systems.
Governments.
------------------------------------------------------------------------
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 Sec. 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
DBPs 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
[[Page 65575]]
OMB Office of Management and Budget
P-A Presence-absence
PCR Polymerase Chain Reaction
PNR Public Notification Rule
PWS Public Water System
RFA Regulatory Flexibility Act
RIA 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
UIC 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 Does 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?
I. 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 Ingestion 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 Use
1. Energy Supply
2. Energy Distribution
3. Energy Use
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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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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.1 for crtieria). Following the initial sanitary survey cycle,
States must conduct these surveys every three years for CWSs (defined
in Sec. 141.2), and every five years for all NCWSs and CWSs that meet
certain performance criteria as discussed in Section IV.A.1.
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
[[Page 65578]]
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
[[Page 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)(1) 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
[[Page 65580]]
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 fecally 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-1).
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-1), 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-1 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 III-1.--Population Served by Ground Water Systems
[Millions]
----------------------------------------------------------------------------------------------------------------
Population served
ground water that
Total population Population served is either
served by ground untreated ground undisinfected or
water systems water treated to less
than 4-log
----------------------------------------------------------------------------------------------------------------
CWSs............................................. 100.4 9.3 56.8
NTNCWSs.......................................... 5.1 3.6 4.7
TNCWSs........................................... 8.7 7.2 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.
[[Page 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.
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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
[[Page 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.1 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
[[Page 65584]]
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 III.C.3.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-1, 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 nonquantified 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).
[[Page 65585]]
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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 TCR 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 GAO (USGAO,
1993).
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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 Sec. 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
[[Page 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 GWSs 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
[[Page 65588]]
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 three
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.1 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)(1)). 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 uncorrected 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.1).
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
[[Page 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)(1)). 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.1) 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.1 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
[[Page 65590]]
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.
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[[Page 65592]]
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 Sec. 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 Sec. 141.21(a) (TCR) has been invalidated under Sec.
141.21(c); or (3) the cause of the total coliform-positive collected
under Sec. 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 Sec.
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 Sec.
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 Sec. 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 Sec. 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 Sec. 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
[[Page 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 Sec.
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 Sec. 141.21. Most of these methods are
also approved for E. coli monitoring under the GWR (see Table IV-1 and
Sec. 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-[beta]-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 Sec. 141.402(c) for Details Regarding These Methods) **
----------------------------------------------------------------------------------------------------------------
Total
Method technology type Method coliforms E. coli TCR/GWR
detected detected approval
----------------------------------------------------------------------------------------------------------------
Multiple tube fermentation............... (LTB/P-A [rarr] BGLB)*..... X ............ X
EC-MUG..................... ............ X X
NA-MUG..................... ............ X X
Enzyme Substrate......................... Colilert/Colilert-18....... X X X
Colisure................... X X X
E* Colite Test............. X X X
Membrane filtration...................... (m-Endo[rarr]LTB/BGLB)*.... X ............ X
EC-MUG..................... ............ X X
MI Agar.................... X X X
[[Page 65594]]
m-ColiBlue 24 Test......... X X 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 sample, 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 Sec. 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 Sec. 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 the 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
[[Page 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 the 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.
[[Page 65596]]
Table IV-2.--Recent Waterborne Disease Outbreaks (PWSs) Reported in
Karst Limestone and Fractured Bedrock (Sensitive) Aquifers
------------------------------------------------------------------------
Number of illnesses/
Location Reference agent
------------------------------------------------------------------------
Outbreaks in Karst Limestone Aquifers
------------------------------------------------------------------------
South Bass Island, OH....... Ohio EPA, 2005; CDC, 1,450/Norovirus,
2005. Campylobacter,
Salmonella.
Walkerton, Ontario, Canada.. Health Canada, 2000; 1,346 cases/E. coli
Bopp et al., 2003; O157:H7 (+
Worthington et al., Campylobacter); 7
2002. deaths.
Brushy Creek, TX............ Bergmire-Sweat et 1,300-1,500 cases/
al., 1999; Lee et Cryptosporidium
al., 2001. (not recognized as
GWUDI until after
the outbreak).
Reading, PA................. Moore et al., 1993.. 551 cases/
Cryptosporidium
(not recognized as
GWUDI until after
the outbreak).
Racine, MO.................. MO Department of 28 cases/HAV.
Health, unpublished
report, 1992.
Drummond Island, MI......... Ground Water 39 cases/Unknown.
Education in
Michigan, 1992;
Chippewa County
Health Department,
unpublished report,
1992.
Cabool, MO.................. Swerdlow et al., 243 cases/E. coli
1992. O157:H7; 4 deaths.
------------------------------------------------------------------------
Outbreaks in Fractured Bedrock Aquifers
------------------------------------------------------------------------
Big Horn Lodge, WY.......... Anderson et al., 35/Norovirus.
2003.
Atlantic City, WY........... Parshionikar et al., 84/Norovirus.
2003.
Couer d'Alene, ID........... Rice et al., 1999... 117/Arcobacter
butzleri.
Island Park, ID............. CDC, 1996........... 82 cases/Shigella.
Northern AZ................. Lawson et al., 1991. 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 (i.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 Assays and Percent Contaminated Wells
Identified
------------------------------------------------------------------------
Fraction
identified
Number of assays (N) (Mean in
percent)
------------------------------------------------------------------------
3.......................................................... 28
6.......................................................... 40
12......................................................... 52
24......................................................... 61
36......................................................... 65
48......................................................... 68
60......................................................... 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
[[Page 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 (NDWAC) recommended that EPA require monitoring for
coliphage and either E. coli or enterococci for source water
monitoring. The reasons stated by SAB and NDWAC 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, 2000h 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
[[Page 65598]]
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 Sec.
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, Sec. 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 Sec.
136.3, Table 1A, Footnote 25. The revised method replaced the 1997
version on the EPA Web site (http://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 estimates that the
coliphage tests (not including 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 Sec. 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
[[Page 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 Sec. 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 Sec. 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)
[[Page 65600]]
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
[[Page 65601]]
[GRAPHIC] [TIFF OMITTED] TR08NO06.004
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
[[Page 65602]]
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 Sec. 141.74(a)(2) (Analytical and
monitoring requirements) at a location approved by the 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 Sec. 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.
[[Page 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 which
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-1). 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-1 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
[[Page 65604]]
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;
[[Page 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 Sec. 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 Sec.
142.10(b)(5), will ensure that systems implement the most appropriate
corrective action.
b. UV Disinfection. 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 being 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 the 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
[[Page 65606]]
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)(1) 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 Sec. 141.202(a) and Sec.
141.203(a) and requires Tier 1 notice for detection of a fecal
indicator in a ground water source sample (see Sec. 141.403) and Tier
2 notice for treatment technique violations (see Sec. 141.404). Also,
this rule requires Tier 3 notice for monitoring violations (see Sec.
141.403 or Sec. 141.404(b)). In addition, this rule amends the
Consumer Confidence Report (CCR) (Sec. 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 Sec. 141.21(e));
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
Sec. 141.402(a) or Sec. 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 Sec.
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 Sec. 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 (Sec.
141.402(a)(2)), source water monitoring following a fecal indicator
source water positive (Sec. 141.402(a)(3)), and, if required by the
State, assessment source water monitoring (Sec. 141.402(b)).
Additionally,
[[Page 65607]]
failure to conduct required compliance monitoring (Sec. 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 Sec. 141.202, Sec.
141.203, and Sec. 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 Sec.
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 Sec.
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 Sec. 141.403(a); (4) for CWSs, a description of
the potential health effects using the health effects language of Sec.
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 Sec. 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 Sec. 141.402(g).
sample or assessment source water
monitoring sample is positive for E.
coli, enterococci, or coliphage (and
is not invalidated).
------------------------------------------------------------------------
Tier 2 Public Notification
------------------------------------------------------------------------
A system fails to take corrective Sec. 141.404(d).
action following:
[dec221] State direction to take
corrective action for a fecal
indicator-positive sample,
[dec221] Receipt of laboratory
notice of fecal indicator-positive
ground water source sample as a
result of triggered source water
monitoring under Sec.
141.402(a)(3), or
[dec221] Receipt of State written
notice of significant deficiency.
A system fails to comply with a State- Sec. 141.404(d).
approved schedule and plan (including
interim measures) related to
correcting a significant deficiency
and/or eliminating fecal contamination
in a ground water source.
A system that elects to provide such Sec. 141.404(d).
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.].
------------------------------------------------------------------------
Tier 3 Public Notification
------------------------------------------------------------------------
A system fails to conduct triggered Sec. 141.403(d).
source water monitoring or assessment
source water monitoring.
A system fails to conduct monitoring to Sec. 141.403(d).
demonstrate compliance with 4-log
treatment requirement.
------------------------------------------------------------------------
[[Page 65608]]
Special Notification Requirements
------------------------------------------------------------------------
CWSs: Notice must include:
System has an uncorrected significant --nature of significant
deficiency (or corrected significant deficiency or ground water
deficiency if directed by the State) fecal contamination, and date.
or a source water fecal indicator- --if the fecal contamination
positive sample. System must repeat has been addressed under Sec.
notice annually until significant 141.403(a), and date.
deficiency corrected or fecal --State-approved plan and
contamination addressed in accordance schedule, including interim
with Sec. 141.403(1). measures completed (if process
[dec221] Provide notice as part of CCR. ongoing).
[dec221] If significant deficiency is --required fecal indicator-
corrected before the next CCR, positive language at:
notification is not required unless --Sec. 141.403(a)(7)(i).
directed by the State.
NCWSs: Notice must include:
System has an uncorrected significant --nature of significant
deficiency (or corrected significant deficiency and date.
deficiency if directed by the State). --State-approved plan and
System must repeat notice annually schedule, including interim
until significant deficiency measures completed (if process
corrected. ongoing).
[dec221] Provide notice in manner --Sec. 141.403(a)(7)(ii).
approved by the State for significant
deficiencies (e.g., posting in
conspicuous places in service area or
direct distribution of information to
public served).
[dec221] If significant deficiency is
corrected within 12 months,
notification is not required unless
directed by the State.
------------------------------------------------------------------------
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
[[Page 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: (1) 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 Sec. 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 Sec. 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
[[Page 65610]]
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 Sec. 141.31, a GWS
must provide the following information to the State (see Sec.
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 with
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 Sec. 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 Sec. 141.31, a GWS
must maintain the following information in its records (see Sec.
141.405(b)): (1) Documentation of corrective actions; (2) documentation
of notice to the public of (a) An uncorrected 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 (Sec. 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
[[Page 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:
Sec. 141.21--Coliform sampling.
Sec. 141.28--Certified laboratories.
Sec. 141.153--Content of the reports.
Sec. 141.202--Tier 1 Public Notice--Form, manner, and
frequency of notice.
Sec. 141.203--Tier 2 Public Notice--Form, manner, and
frequency of notice.
Sec. 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.1). 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
[[Page 65612]]
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
Sec. 142.15. The final GWR adds the following three reporting
requirements to these provisions (Sec. 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 Sec. 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 should 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 1415(a)(1)(B)).
(2) EPA may grant a variance from any treatment technique
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)(1)(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
[[Page 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)(1) 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.
[[Page 65614]]
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.1 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)(1)). 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 and 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$]
----------------------------------------------------------------------------------------------------------------
3% Discount rate 7% Discount rate
---------------------------------------------------------------
Rule alternative 5th-95th 5th-95th
Mean Percentiles Mean Percentiles
----------------------------------------------------------------------------------------------------------------
National GWR Benefits
----------------------------------------------------------------------------------------------------------------
Enhanced COI:
Risk-Targeted Approach...................... $19.7 $6.5-$45.4 $16.8 $5.5-$38.6
Sanitary Survey............................. 3.6 0.9-9.3 2.9 0.7-7.5
Multi-barrier Approach...................... 21.3 7.1-48.7 18.2 6.0-41.6
[[Page 65615]]
Across the Board Disinfection............... 70.2 18.3-177.0 61.9 16.1-156.3
Traditional COI:
Risk-Targeted Approach...................... 10.0 2.2-27.0 8.6 1.9-22.9
Sanitary Survey............................. 1.9 0.3-5.5 1.5 0.2-4.5
Multi-barrier Approach...................... 10.8 2.5-28.9 9.3 2.1-24.8
Across the Board Disinfection............... 35.5 6.5-102.4 31.5 5.7-90.8
----------------------------------------------------------------------------------------------------------------
National GWR Costs
----------------------------------------------------------------------------------------------------------------
Risk-Targeted Approach.......................... 61.8 45.2-81.4 62.3 46.1-81.6
Sanitary Survey................................. 15.3 11.8-19.2 15.3 11.9-19.0
Multi-barrier Approach.......................... 67.9 49.4-89.5 69.4 51.0-90.6
Across the Board Disinfection................... 686.4 636.8-735.4 665.3 612.3-717.0
----------------------------------------------------------------------------------------------------------------
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
[[Page 65616]]
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 et
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 et 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 et 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 et 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 et 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-community Wells).
Francy et al., 2004 (Southeast Michigan).
Atherholt et al., 2003 (New Jersey).
Davis and Witt, 2000 (Missouri Ozark Plateau 1).
Femmer, 2000 (Missouri Ozark Plateau 2).
USEPA et al., 1998d (Wisconsin Migrant Worker Camp).
Doherty, 1998 (New England).
Battigelli, 1999 (Three-State Study: Wisconsin).
Banks et al., 2001 (Three-State Study: Maryland).
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 et al., 2002,
Abbaszadegan, et al., 2003 and Lindsey et 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 et al., 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 et 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.
[[Page 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
P1, P2, P3, and P4, respectively. The categories and parameters P1
through P4 are illustrated in the Venn diagram of Figure VII-1.
[GRAPHIC] [TIFF OMITTED] TR08NO06.005
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:
P1 = 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 P1, 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,
[[Page 65618]]
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, et 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 echovirus (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.
[[Page 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 $22.9 million at a seven percent discount rate.
Table VII-3.--Summary of Annualized Present Value Quantified Benefits
[$Millions, 2003$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized benefits at three percent Annualized benefits at seven percent
discount rate discount rate
-------------------------------------------------------------------------------------
System type 90 Percent confidence bound 90 Percent confidence bound
---------------------------------- ---------------------------------
Mean Lower (5th Upper (95th Mean Lower (5th Upper (95th
%ile) %ile) %ile) %ile)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enhanced COI:
CWSs.......................................................... $16.0 $5.4 $37.0 $13.7 $4.6 $31.6
NTNCWSs....................................................... 0.9 0.3 2.2 0.8 0.2 1.8
TNCWSs........................................................ 2.7 0.8 6.2 2.3 0.7 5.1
-------------------------------------------------------------------------------------
Total..................................................... 19.7 6.5 45.4 16.8 5.5 38.6
Traditional COI:
CWSs.......................................................... 8.2 1.9 22.3 7.1 1.6 19.1
NTNCWSs....................................................... 0.5 0.1 1.3 0.4 0.1 1.0
TNCWSs........................................................ 1.3 0.3 3.4 1.1 0.2 2.8
-------------------------------------------------------------------------------------
Total..................................................... 10.0 2.2 27.0 8.6 1.9 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.
1. 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
----------------------------------------------------------------------------------------------------------------
Illnesses per year Deaths per year
----------------------------------------------------------------------------------------------------------------
5th-95th 5th-95th
Virus type Mean Percentiles Mean Percentiles
----------------------------------------------------------------------------------------------------------------
Type A (rotavirus).......................... 175,168 32,652-435,381 1.2 0.2-2.9
Type B (enterovirus or echovirus)........... 10,018 501-40,718 2.0 0.0-8.1
-------------------------------------------------------------------
Total................................... 185,186 33,153-476,099 3.2 0.3-11.0
----------------------------------------------------------------------------------------------------------------
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
[[Page 65620]]
calculated viral illnesses and deaths avoided due to the GWR by system
type. More detailed information about the GWR benefits assessment and
all data and analyses used in predicting those benefits can be found in
the GWR EA (USEPA, 2006d).
Table VII-5a.--Summary of Annual Viral Illnesses and Deaths Avoided for the GWR
----------------------------------------------------------------------------------------------------------------
Illnesses avoided per year Deaths avoided per year
----------------------------------------------------------------------------------------------------------------
5th-95th 5th-95th
Virus type Mean Percentiles Mean Percentiles
----------------------------------------------------------------------------------------------------------------
Type A (rotavirus).......................... 39,442 10,093-79,925 0.3 0.1-0.5
Type B (enterovirus or echovirus)........... 2,426 181-8,114 0.5 0.0-1.6
-------------------------------------------------------------------
Total................................... 41,868 10,274-88,039 0.7 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
----------------------------------------------------------------------------------------------------------------
Illnesses avoided per year Deaths avoided per year
----------------------------------------------------------------------------------------------------------------
5th-95th 5th-95th
System type Mean Percentiles Mean Percentiles
----------------------------------------------------------------------------------------------------------------
CWSs........................................ 32,031 8,704-68,994 0.6 0.1-1.8
NTNCWSs..................................... 2,094 533-4,308 0.03 0.0-0.1
TNCWSs...................................... 7,743 1,037-14,738 0.1 0.01-0.2
-------------------------------------------------------------------
Total................................... 41,868 10,274-88,039 0.7 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 illnesses 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
[[Page 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
[[Page 65622]]
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 GWR EA (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
[[Page 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?
1. 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.
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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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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.1. 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.
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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
[[Page 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, 2006d).
Table VII-10.--Representative Corrective Actions
------------------------------------------------------------------------
Representative
corrective actions Note
------------------------------------------------------------------------
For Significant Deficiencies Replace a Sanitary Low cost option.
at Source Identified by Well Seal.
Sanitary Survey.
Rehabilitate an High cost option.
Existing Well.
For Entry Points with a Non-Treatment Interim disinfection
Fecal Indicator-Positive Options. is included for
Ground Water Source Sample. Rehabilitate an costing.
Existing Well.
Drill a New Well....
Purchase Water......
Eliminate Source of
Contamination.
Treatment Options... Chlorine gas and
Disinfection hypochlorite will
Alternatives or be most likely
Nanofiltration. 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 (Sec. 142.14) and reporting (Sec. 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 nonquantified costs are much smaller than the nonquantified
benefits. These nonquantified 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
[[Page 65630]]
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 VII.A 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.
[[Page 65631]]
[GRAPHIC] [TIFF OMITTED] TR08NO06.012
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.
[[Page 65632]]
Table VII-12a.--Incremental Net Benefits by Rule Alternative--Enhanced COI
[Annualized Present Value Mean, $Millions, 2003$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual quantified costs Annual quantified Incremental Incremental Incremental
benefits (enhanced COI) costs benefits* net benefits*
Rule alternatives -------------------------------------------------------------------------------------------------
A B C D E = D-C
--------------------------------------------------------------------------------------------------------------------------------------------------------
Three Percent Discount Rate
(in dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternative 1: Sanitary Survey and Corrective Action.. 15.3 (11.8-19.2) 3.6 (0.9-9.3) 15.3 3.6 -11.7
Final Rule: Risk-targeted Approach**.................. 61.8 (45.2-81.4) 19.7 (6.5-45.4) 46.5 16.1 -30.4
Alternative 3: Multi-Barrier Approach................. 67.9 (49.4-89.5) 21.3 (7.1-48.7) 6.1 1.6 -4.5
Alternative 4: Across-the-Board Disinfection.......... 686.4 (636.8-735.4) 70.2 (18.3-177.0) 618.5 48.9 -569.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Seven Percent Discount Rate
(in dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternative 1: Sanitary Survey and Corrective Action.. 15.3 (11.9-19.0) 2.9 (0.7-7.5) 15.3 2.9 -12.4
Final Rule: Risk-targeted Approach**.................. 62.3 (46.1-81.6) 16.8 (5.5-38.6) 47.0 13.9 -33.1
Alternative 3: Multi-Barrier Approach................. 69.4 (51.0-90.6) 18.2 (6.0-41.6) 7.1 1.4 -5.7
Alternative 4: Across-the-Board Disinfection.......... 665.3 (612.3-717.0) 61.9 (16.1-156.3) 595.9 43.8 -552.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
*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.
Table VII-12b.--Incremental Net Benefits by Rule Alternative--Traditional COI
[Annualized Present Value Mean, $Millions, 2003$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual quantified costs Annual quantified Incremental Incremental Incremental
benefits (traditional costs benefits* net benefits*
Rule alternatives ------------------------- COI) -----------------------------------------------
-------------------------
A B C D E = D-C
--------------------------------------------------------------------------------------------------------------------------------------------------------
Three Percent Discount Rate
(in dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternative 1: Sanitary Survey and Corrective Action.. 15.3 (11.8-19.2) 1.9 (0.3-5.5) 15.3 1.9 -13.5
Final Rule: Risk-targeted Approach**.................. 61.8 (45.2-81.4) 10.0 (2.2-27.0) 46.5 8.2 -38.3
Alternative 3: Multi-Barrier Approach................. 67.9 (49.4-89.5) 10.8 (2.5-28.9) 6.1 0.8 -5.3
Alternative 4: Across-the-Board Disinfection.......... 686.4 (636.8-735.4) 35.5 (6.5-102.4) 618.5 24.7 -593.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
Seven Percent Discount Rate
(in dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternative 1: Sanitary Survey and Corrective Action.. 15.3 (11.9-19.0) 1.5 (0.2-4.5) 15.3 1.5 -13.8
Final Rule: Risk-targeted Approach**.................. 62.3 (46.1-81.6) 8.6 (1.9-23.0) 47.0 7.1 -39.9
Alternative 3: Multi-Barrier Approch.................. 69.4 (51.0-90.6) 9.3 (2.1-24.8) 7.1 0.7 -6.4
Alternative 4: Across-the-Board Disinfection.......... 665.3 (612.3-717.0) 31.5 (5.7-90.8) 595.9 22.2 -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.
[[Page 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 (DBPs). Risk from DBPs has already
been addressed in the Stage 1 Disinfection Byproducts Rule (DBPR)
(USEPA, 1998c) and additional consideration of DBP risk has been
addressed in the recently published final Stage 2 DBPR (USEPA, 2006g).
In general, GWSs are less likely to experience high levels of DBPs than
surface water systems because they have lower levels of naturally
occurring organic materials (generally represented by total organic
carbon (TOC)) that contribute to DBP formation. For the most part, GWSs
with high levels of TOC 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.
I. 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
[[Page 65634]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infants and
Virus type Health effect young children Elderly adults >65 Immunocompromised (all Total sensitive
<5 years old years old ages) subgroups
--------------------------------------------------------------------------------------------------------------------------------------------------------
Type A (Rotavirus).................... Illness............... 2,588 Illness: 5,559........ Illness: 126............ Illness: 8,465.
Death................. 0.02
Type B (Enterovirus or Echovirus)..... Illness............... 191 Deaths: 0.10.......... Deaths: 0.002........... Deaths: 0.15.
Death................. 0.04
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
[[Page 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.
J. 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.1.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.
[[Page 65636]]
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. coli-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 (NDWAC, 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.
[[Page 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 $62 million, respectively, using a seven percent
discount rate). Overall, the GWR will reduce the risk of fecal
contamination reaching the consumer. The monetized costs of these
provisions were compared to the monetized benefits that result from the
reduction in some viral illnesses and deaths. In addition, other non-
monetized benefits further justify the costs of this rule. For example,
including bacterial illness would significantly increase the benefits
without any increases in costs.
Table VII-15 shows the net benefits for this rule as well as the
three regulatory alternatives considered. The net benefits include only
the monetized values (i.e., nonquantified costs and benefits are not
considered). The nonquantified benefits are likely to be significantly
greater than the quantified benefits (and also much greater that the
nonquantified costs). Thus, the net benefits of each of the options may
be higher than shown in these estimates. Nonquantified costs are also
not included.
Table VII-14.--Estimated Annualized National Benefits and Costs for the GWR
[$Millions, 2003$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
3% Discount rate 7% Discount rate
-----------------------------------------------------------------------------------------------
90 percent confidence bound 90 percent confidence bound
-------------------------------- -------------------------------
Mean Lower (5th Upper (95th Mean Lower (5th Upper (95th
%ile) %ile) %ile) %ile)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Enhanced COI:
Benefits............................................ $19.7 $6.5 $45.4 $16.8 $5.5 $38.6
Costs............................................... 61.8 45.2 81.4 62.3 46.1 81.6
Net Benefits........................................ -42.1 Note 1 Note 1 -45.5 Note 1 Note 1
Traditional COI:
Benefits............................................ 10.0 2.2 27.0 8.6 1.9 22.9
Costs............................................... 61.8 45.2 81.4 62.3 46.1 81.6
Net Benefits........................................ -51.8 Note 1 Note 1 -53.7 Note 1 Note 1
Nonquantified Benefits.............................. Decreased incidence of other acute viral disease endpoints.
Decreased incidence of bacterial illness and death.
Decreased incidence of chronic bacterial or viral illness sequellae.
[[Page 65638]]
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 production). 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
------------------------------------------------------------------------
Annualized value
---------------------------------------
Rule alternative 3% discount rate 7% discount rate
(dollars) (dollars)
------------------------------------------------------------------------
Enhanced COI:
Alternative 1............... -11.7............ -12.4
Final Rule.................. -42.1............ -45.5
Alternative 3............... -46.6............ -51.2
Alternative 4............... -616.2........... -603.4
Traditional COI:
Alternative 1............... -13.5............. -13.8
Final Rule.................. -51.8............ -53.7
Alternative 3............... -57.1............ -60.1
Alternative 4............... -650.9........... -633.8
Nonquantified Benefits...... 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.
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.
Cost for compliance monitoring at some
systems that already disinfect.
------------------------------------------------------------------------
[[Page 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
[2003$]
------------------------------------------------------------------------
Cost per viral illness avoided
Rule alternative -------------------------------
3% (dollars) 7% (dollars)
------------------------------------------------------------------------
Alternative 1........................... 2,045 2,044
Final Rule.............................. 1,476 1,488
Alternative 3........................... 1,495 1,527
Alternative 4........................... 4,420 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 VII.A 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?
1. 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
[[Page 65640]]
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 SDWIS 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,
[[Page 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 VII.A 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 et 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 et 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 et 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. coli) 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 et 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 et 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 et al., 1969) to determine the
range of
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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 VII.A. 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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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 SDWA, 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 this 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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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 the 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 (99 percent) 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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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, 2000a). 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.
[[Page 65646]]
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.1 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.
I. 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 Sec.
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).
[[Page 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.
J. 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 (NDWAC), 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.
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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. 2000i. 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-97-001b.
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--July 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 31, 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. Drinking Water; National Primary Drinking Water
Regulations: Total Coliforms (Including Fecal Coliforms and E.
Coli); Final Rule. 54 FR 27544, June 29, 1989.
USEPA. 1989b. Drinking Water; National Primary Drinking Water
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 (USGAO). Drinking Water Key
Quality Assurance Program is Flawed and Underfunded, GAO/RCED-93-97.
April 1993.
Vaughn, J.M. 1996. Sample Analyses. Attachment, unpublished letter
on the analysis of alluvial wells in Missouri by J. Lane and K.
Duzan, Missouri Department of Natural Resources, Rolla, MO, November
7, 1996.
Ward, R.L, D.I. Bernstein, E.C. Young, J.R. Sherwood, D.R. Knowlton,
and G.M. Schiff. 1986. Human Rotavirus Studies in Volunteers:
Determination of Infectious Dose and Serological Response to
Infection. Journal of Infectious Diseases. 154(5):871.
Worthington, S.R.H., C.C. Smart, and W.W. Ruland. 2002. Assessment
of groundwater velocities to the municipal wells at Walkerton.
Ground and Water: Theory to Practice. Proceedings of the 55th
Canadian Geotechnical and 3rd Joint IAH-CNC and CGS Groundwater
Specialty Conferences, Niagara Falls, Ontario, October 20-23, 2002.
Edited by D. Stolle, A.R. Piggott and J.J. Crowder and published by
the Southern Ontario Section of the Canadian Geotechnical Society.
Pp. 1081-1086.
Yanko, W.A., J.L. Jackson, F.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. Water Resource. 33:53-64.
Yates, M.V., R.W. Citek, M.F. Kamper, and A.M. Salazar. 1999.
Detecting Enteroviruses in Water: Comparing Infectivity, Molecular,
and Combination Models. American Water Works 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:
[[Page 65651]]
PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
0
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, 2601-2671; 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.
0
2. In Sec. 9.1 the table is amended by adding entries Sec. 141.401-
141.405'', Sec. 142.14(d)(17)'', Sec. 142.15(c)(7)'' and Sec.
142.16(o)'' in numerical order, as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB control
40 CFR citation 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(o)............................................... 2040-0271
------------------------------------------------------------------------
* * * * *
PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS
0
3. The authority citation for part 141 continues to read as follows:
Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9, and 300j-11.
0
4. Section 141.21 is amended by adding paragraph (d)(3) to read as
follows:
Sec. 141.21 Coliform sampling.
* * * * *
(d) * * *
(3) Sanitary surveys conducted by the State under the provisions of
Sec. 142.16(o)(2) of this chapter may be used to meet the sanitary
survey requirements of this section.
* * * * *
0
5. Section 141.28 is amended by revising paragraph (a) to read as
follows:
Sec. 141.28 Certified laboratories.
(a) For the purpose of determining compliance with Sec. 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.
* * * * *
0
6. Section 141.153 is amended by adding a new paragraph (h)(6) to read
as follows:
Sec. 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 Sec.
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 Sec.
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 Sec. 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 Sec. 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
Sec. 141.402(d), the potential health effects using the health effects
language of Appendix A of subpart O.
[[Page 65652]]
(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.
* * * * *
0
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Traditional MCL in To convert for Major sources in Health effects
Contaminant (units) mg/L CCR, multiply by MCL in CCR units MCLG drinking water language
--------------------------------------------------------------------------------------------------------------------------------------------------------
Microbiological Contaminants:
* * * * * * *
Fecal Indicators (enterococci or TT................ .................. TT................ N/A............... Human and animal Fecal indicators
coliphage). fecal waste. are microbes
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
diarrhea, cramps,
nausea,
headaches, or
other symptoms.
They may pose a
special health
risk for infants,
young children,
some of the
elderly, and
people with
severely
compromised
immune systems.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * *
TT=Treatment Technique.
0
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:
Sec. 141.202 Tier 1 Public Notice--Form, manner, and frequency of
notice.
(a) * * *
Table 1 to Sec. 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 Sec. 141.402(a) and Sec. 141.402(b).
* * * * *
0
9. Section 141.203 is amended by adding entry (4) to Table 1 in
paragraph (a) to read as follows:
Sec. 141.203 Tier 2 Public Notice--Form, manner, and frequency of
notice.
(a) * * *
Table 1 to Sec. 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 Sec. 141.403(a).
* * * * *
0
10. Appendix A to Subpart Q of Part 141 is amended to read as follows:
0
a. Adding I.A.11;
0
b. Redesignating entry IV.F as entry IV.G; and
0
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 violations \2\ Monitoring and testing
-------------------------------- procedure violations
-------------------------------
Contaminant Tier of public Tier of public
notice Citation notice Citation
required required
----------------------------------------------------------------------------------------------------------------
I. Violations of National Primary Drinking Water Regulations (NPDWR): \3\
A. Microbiological Contaminants
----------------------------------------------------------------------------------------------------------------
* * * * * * *
11. Ground Water Rule violations................ 2 141.404 3 141.402(h).
141.403(d).
[[Page 65653]]
* * * * * * *
IV. Other Situations Requiring Public Notification
----------------------------------------------------------------------------------------------------------------
* * * * * * *
F. Source Water Sample Positive for GWR Fecal 1 141.402(g) N/A N/A
indicators: E. coli, enterococci, or coliphage.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Violations and other situations not listed in this table (e.g., failure to prepare Consumer Confidence
Reports) do not require notice, unless otherwise determined by the primacy agency. Primacy agencies may, at
their option, also require a more stringent public notice tier (e.g., Tier 1 instead of Tier 2 or Tier 2
instead of Tier 3) for specific violations and situations listed in this Appendix, as authorized under Sec.
141.202(a) and Sec. 141.203(a).
\2\ MCL--Maximum contaminant level, MRDL--Maximum residual disinfectant level, TT--Treatment technique.
\3\ The term Violations of National Primary Drinking Water Regulations (NPDWR) is used here to include
violations of MCL, MRDL, treatment technique, monitoring, and testing procedure requirements.
* * * * *
0
11. Appendix B of Subpart Q of Part 141 is amended by adding entries
A.1.c and A.1.d in numerical order to read as follows:
Appendix B to Subpart Q of Part 141--Standard Health Effects Language for Public Notification
----------------------------------------------------------------------------------------------------------------
Standard health effects
Contaminant MCLG \1\ mg/L MCL \2\ mg/L language for public
notification
----------------------------------------------------------------------------------------------------------------
National Primary Drinking Water Regulations (NPDWR)
A. Microbiological Contaminants
----------------------------------------------------------------------------------------------------------------
* * * * * * *
1c. Fecal indicators (GWR): Zero.................. TT.................... Fecal indicators are
i. E. coli None.................. TT.................... microbes whose presence
ii. enterococci None.................. TT.................... indicates that the water
iii. coliphage may be contaminated with
human or animal wastes.
Microbes in these wastes
can cause short-term
health effects, such as
diarrhea, cramps, nausea,
headaches, or other
symptoms. They may pose a
special health risk for
infants, young children,
some of the elderly, and
people with severely
compromised immune
systems.
1d. Ground Water Rule (GWR) TT None.................. TT.................... Inadequately treated or
violations. inadequately protected
water may contain disease-
causing organisms. These
organisms can cause
symptoms such as diarrhea,
nausea, cramps, and
associated headaches.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ MCLG--Maximum contaminant level goal.
\2\ MCL--Maximum contaminant level.
* * * * *
0
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
* * * * *
0
13. A new subpart S is added to read as follows:
Subpart S--Ground Water Rule
Sec.
141.400 General requirements and applicability.
141.401 Sanitary surveys for 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
Sec. 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
[[Page 65654]]
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 Sec. 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 Sec. 141.402.
(3) Treatment technique requirements, described in Sec. 141.403,
that apply to ground water systems that have fecally contaminated
source waters, as determined by source water monitoring conducted under
Sec. 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 Sec. 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.
Sec. 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)(1) 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.
Sec. 141.402 Ground water source microbial monitoring and analytical
methods.
(a) Triggered source water monitoring.--(1) General requirements. A
ground water system must conduct triggered source water monitoring if
the conditions identified in paragraphs (a)(1)(i) and (a)(1)(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 Sec.
141.21(a) is total coliform-positive and the sample is not invalidated
under Sec. 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 Sec. 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 Sec. 141.21(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 Sec. 141.21(b) and to satisfy the monitoring
requirements of paragraph (a)(2) of this section for that ground water
source only if the State approves the use of E. coli as a fecal
indicator for source water monitoring under this paragraph (a). If the
repeat sample collected from the ground water source is E.coli
positive, the system must comply with paragraph (a)(3) of this section.
(3) Additional Requirements. If the State does not require
corrective action under Sec. 141.403(a)(2) for a fecal indicator-
positive source water sample collected under paragraph (a)(2) of this
section that is not invalidated under paragraph (d) of this section,
the system must collect five additional source water samples from the
same source within 24 hours of being notified of the fecal indicator-
positive sample.
(4) Consecutive and Wholesale Systems. (i). In addition to the
other requirements of this paragraph (a), a consecutive ground water
system that has a total coliform-positive sample collected under Sec.
141.21(a) must notify the wholesale system(s) within 24 hours of being
notified of the total coliform-positive sample.
(ii) In addition to the other requirements of this paragraph (a), a
wholesale ground water system must comply with paragraphs (a)(4)(ii)(A)
and (a)(4)(ii)(B) of this section.
(A) A wholesale ground water system that receives notice from a
consecutive system it serves that a sample collected under Sec.
141.21(a) 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
[[Page 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 by that ground water source
of the fecal indicator source water positive within 24 hours of being
notified of the ground water source sample monitoring result and must
meet the requirements of paragraph (a)(3) of this section.
(5) Exceptions to the Triggered Source Water Monitoring
Requirements. A ground water system is not required to comply with the
source water monitoring requirements of paragraph (a) of this section
if either of the following conditions exists:
(i) The State determines, and documents in writing, that the total
coliform-positive sample collected under Sec. 141.21(a) is caused by a
distribution system deficiency; or
(ii) The total coliform-positive sample collected under Sec.
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 Water 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 indicator \1\ Methodology Method citation
------------------------------------------------------------------------
E. coli....................... Colilert \3\.......... 9223 B.\2\
Colisure \3\.......... 9223 B.\2\
Membrane Filter Method EPA Method
with MI Agar. 1604.\4\
m-ColiBlue24 Test \5\. ................
E*Colite Test \6\..... ................
EC-MUG \7\............ 9221 F.\2\
NA-MUG \7\............ 9222 G.\2\
Enterococci Multiple-Tube 9230B.\2\
Technique.
Membrane Filter 9230C.\2\
Technique.
Membrane Filter EPA Method
Technique. 1600.\8\
Enterolert \9\........ ................
Coliphage..................... Two-Step Enrichment EPA Method
Presence-Absence 1601.\10\
Procedure.
Single Agar Layer EPA Method
Procedure. 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/federal_register/code_of_federal_regulations/ibr_locations.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[deg]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.
\3\ Medium is available through IDEXX Laboratories, Inc., One IDEXX
Drive, Westbrook, Maine 04092.
\4\ EPA Method 1604: Total Coliforms and Escherichia coli in Water by
Membrane Filtration Using a Simultaneous Detection Technique (MI
Medium); September 2002, EPA 821-R-02-024. 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[reg] 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
Escherichia 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.
\7\ EC-MUG (Method 9221F) or NA-MUG (Method 9222G) can be used for E.
coli testing step as described in Sec. 141.21(f)(6)(i) or (ii) after
use of Standard Methods 9221 B, 9221 D, 9222 B, or 9222 C.
[[Page 65656]]
\8\ EPA Method 1600: Enterococci in Water by Membrane Filtration Using
membrane-Enterococcus Indoxyl-[beta]-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.
\10\ EPA 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 Avenue,
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.pdf
or 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)(1)(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. (1) 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 Sec. 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
Sec. 141.204.
Sec. 141.403 Treatment technique requirements for ground water
systems.
(a) Ground water systems with significant deficiencies or source
water fecal contamination.
(1) 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 Sec.
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 Sec. 141.402(a)(2), Sec.
141.402(a)(4), or Sec. 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 Sec. 141.402(a)(3) was found to be fecal indicator-
positive, or direction from the State that a fecal indicator'positive
collected under Sec. 141.402(a)(2), Sec. 141.402(a)(4), or Sec.
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 Sec. 141.402(a)(3) was found to be fecal
indicator-positive, or direction from the State that a fecal indicator-
positive sample collected under Sec. 141.402(a)(2), Sec.
141.402(a)(4), or Sec. 141.402(b) 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
[[Page 65657]]
with any schedule specified by the State.
(6) Corrective Action Alternatives. Ground water systems that meet
the conditions of paragraph (a)(1) 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 Sec. 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 Sec.
141.402(d) must inform the public served by the water system under
Sec. 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 Sec. 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 monitoring--(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 Sec. 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 Sec. 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
Sec. 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)(1) 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 Sec. 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 Sec. 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
[[Page 65658]]
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 Sec. 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 Sec. 141.204.
Sec. 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 Sec. 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
Sec. 141.403(a)(1) or Sec. 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 Sec.
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 Sec.
141.203 for the treatment technique violations specified in paragraphs
(a), (b) and (c) of this section.
Sec. 141.405 Reporting and recordkeeping for ground water systems.
(a) Reporting. In addition to the requirements of Sec. 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
Sec. 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 Sec. 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 Sec.
141.402(a) does not conduct source water monitoring under Sec.
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 Sec. 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 Sec.
141.403(a)(7). Documentation shall be kept for a period of not less
than three years.
(3) Records of decisions under Sec. 141.402(a)(5)(ii) and records
of invalidation of fecal indicator-positive ground water source samples
under Sec. 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 Sec. 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 Sec. 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
[[Page 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
0
14. The authority citation for part 142 continues to read as follows:
Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9, and 300j-11.
0
15. Section 142.14 is amended by adding paragraph (d)(17) to read as
follows:
Sec. 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 Sec.
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)(1) 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).
* * * * *
0
16. Section 142.15 is amended by adding paragraph (c)(7) to read as
follows:
Sec. 142.15 Reports by States.
* * * * *
(c) * * *
(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 Sec. 142.16(o)(2) for
each ground water system.
(ii) Corrective action requirements. For any corrective action
under Sec. 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).
* * * * *
0
17. Section 142.16 is amended as follows:
0
a. Revise paragraph (a)(2)(iii), and
0
b. Add paragraph (o) to read as follows:
Sec. 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 Sec.
141.402(a)(2), Sec. 141.402(a)(3) and Sec. 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 any source water
fecal contamination identified during source water monitoring under
Sec. 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 Sec.
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
[[Page 65660]]
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 Sec. 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 Sec. Sec.
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 Sec. Sec.
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
Sec. 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
Sec. 141.402(d)(1)(ii) of this chapter.
(iv) The criteria the State will use to allow source water
microbial monitoring at a location after treatment under Sec.
141.402(e)(1) 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 Sec. 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
Sec. 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.
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[FR Doc. 06-8763 Filed 11-7-06; 8:45 am]
BILLING CODE 6560-50-P